Sample records for reference serum lot

  1. Serum free light chain reference values: a critical approach.

    PubMed

    Altinier, Sara; Seguso, Mara; Zaninotto, Martina; Varagnolo, Mariacristina; Adami, Fausto; Angeli, Paolo; Plebani, Mario

    2013-05-01

    The clinical usefulness of serum free light chain (FLC) measurement in the management of patients with plasma cell proliferative disorders has been reported in several papers, and most clinical studies use the reference ranges declared by the manufacturer. The aim of the present study was to evaluate the reproducibility of FLCs immunoassay and to validate the reference range, before introducing it in routine setting. Internal quality control materials and a pool of fresh serum samples were used to evaluate imprecision; 162 fresh sera from healthy blood donors were analyzed to evaluate the reference range for FLCs. In order to verify the κ/λ FLC ratio, 43 sera from patients with polyclonal hypergammaglobulinemia were tested. The FLC immunoassay was performed using a nephelometer with the Freelite reagents. The imprecision studies performed using a serum pool tested with two different lots of reagents showed a mean CV of 16.09% for κFLC and of 16.72% for λFLC. Lower CV%s and different mean values were found by calculating the results from each specific lot separately, while different results were obtained using the control materials provided by the manufacturer. In reference subjects, the 2.5-97.5th percentiles were found to be 4.52-22.33 and 4.84-21.88mg/L for κFLC and λFLC, respectively. The range for κ/λ ratio (0.65-2.36) was validated with the values obtained from subjects with polyclonal hypergammaglobulinemia. In retesting 15 samples from blood donor subjects with a different lot of reagents, mean bias percentages of 17.60 for κFLC and 15.26 for λFLC were obtained. These findings confirm the lot-to-lot variability of the FLC assays also in the measurement of polyclonal light chains, as well as the need to carefully validate the reference values. Published by Elsevier Inc.

  2. Comparative analyses of industrial-scale human platelet lysate preparations.

    PubMed

    Pierce, Jan; Benedetti, Eric; Preslar, Amber; Jacobson, Pam; Jin, Ping; Stroncek, David F; Reems, Jo-Anna

    2017-12-01

    Efforts are underway to eliminate fetal bovine serum from mammalian cell cultures for clinical use. An emerging, viable replacement option for fetal bovine serum is human platelet lysate (PL) as either a plasma-based or serum-based product. Nine industrial-scale, serum-based PL manufacturing runs (i.e., lots) were performed, consisting of an average ± standard deviation volume of 24.6 ± 2.2 liters of pooled, platelet-rich plasma units that were obtained from apheresis donors. Manufactured lots were compared by evaluating various biochemical and functional test results. Comprehensive cytokine profiles of PL lots and product stability tests were performed. Global gene expression profiles of mesenchymal stromal cells (MSCs) cultured with plasma-based or serum-based PL were compared to MSCs cultured with fetal bovine serum. Electrolyte and protein levels were relatively consistent among all serum-based PL lots, with only slight variations in glucose and calcium levels. All nine lots were as good as or better than fetal bovine serum in expanding MSCs. Serum-based PL stored at -80°C remained stable over 2 years. Quantitative cytokine arrays showed similarities as well as dissimilarities in the proteins present in serum-based PL. Greater differences in MSC gene expression profiles were attributable to the starting cell source rather than with the use of either PL or fetal bovine serum as a culture supplement. Using a large-scale, standardized method, lot-to-lot variations were noted for industrial-scale preparations of serum-based PL products. However, all lots performed as well as or better than fetal bovine serum in supporting MSC growth. Together, these data indicate that off-the-shelf PL is a feasible substitute for fetal bovine serum in MSC cultures. © 2017 AABB.

  3. Detection of bovine viral diarrhoea virus nucleic acid, but not infectious virus, in bovine serum used for human vaccine manufacture.

    PubMed

    Laassri, Majid; Mee, Edward T; Connaughton, Sarah M; Manukyan, Hasmik; Gruber, Marion; Rodriguez-Hernandez, Carmen; Minor, Philip D; Schepelmann, Silke; Chumakov, Konstantin; Wood, David J

    2018-06-22

    Bovine viral diarrhoea virus (BVDV) is a cattle pathogen that has previously been reported to be present in bovine raw materials used in the manufacture of biological products for human use. Seven lots of trivalent measles, mumps and rubella (MMR) vaccine and 1 lot of measles vaccine from the same manufacturer, together with 17 lots of foetal bovine serum (FBS) from different vendors, 4 lots of horse serum, 2 lots of bovine trypsin and 5 lots of porcine trypsin were analysed for BVDV using recently developed techniques, including PCR assays for BVDV detection, a qRT-PCR and immunofluorescence-based virus replication assays, and deep sequencing to identify and genotype BVDV genomes. All FBS lots and one lot of bovine-derived trypsin were PCR-positive for the presence of BVDV genome; in contrast all vaccine lots and the other samples were negative. qRT-PCR based virus replication assay and immunofluorescence-based infection assay detected no infectious BVDV in the PCR-positive samples. Complete BVDV genomes were generated from FBS samples by deep sequencing, and all were BVDV type 1. These data confirmed that BVDV nucleic acid may be present in bovine-derived raw materials, but no infectious virus or genomic RNA was detected in the final vaccine products. Copyright © 2018 International Alliance for Biological Standardization. All rights reserved.

  4. Strategies to Suspension Serum-Free Adaptation of Mammalian Cell Lines for Recombinant Glycoprotein Production.

    PubMed

    Caron, Angelo Luis; Biaggio, Rafael Tagé; Swiech, Kamilla

    2018-01-01

    Serum-free suspension cultures are preferably required for recombinant protein production due to its readiness in upstream/downstream processing and scale-up, therefore increasing process productivity and competitiveness. This type of culture replaces traditional cell culturing as the presence of animal-derived components may introduce lot-a-lot variability and adventitious pathogens to the process. However, adapting cells to serum-free conditions is challenging, time-consuming, and cell line and medium dependent. In this chapter, we present different approaches that can be used to adapt mammalian cell lines from an anchorage-dependent serum supplemented culture to a suspension serum-free culture.

  5. [Selecting methods of controls concentration for internal quality control and continuity of control chart between different reagent lots for HBsAg qualitative detection].

    PubMed

    Li, Jin-ming; Zheng, Huai-jing; Wang, Lu-nan; Deng, Wei

    2003-04-01

    To establish a model for one choosing controls with a suitable concentration for internal quality control (IQC) with qualitative ELISA detection, and a consecutive plotting method on Levey-Jennings control chart when reagent kit lot is changed. First, a series of control serum with 0.2, 0.5, 1.0, 2.0 and 5.0ng/ml HBsAg respectively were assessed for within-run and between-run precision according to NCCLs EP5 document. Then, a linear regression equation (y=bx + a) with best correlation coefficient (r > 0.99) was established based on S/CO values of the series of control serum. Finally, one could choose controls with S/CO value calculated from the equation (y = bx + a) minus the product of the S/CO value multiplying three-fold between-run CV to be still more than 1.0 for IQC use. For consecutive plotting on Levey-Jennings control chart when ELISA kit lot was changed, the new lot kits were used to detect the same series of HBsAg control serum as above. Then, a new linear regression equation (y2 = b2x2 + a2) with best correlation coefficient was obtained. The old one (y1 =b1x1 + a1) could be obtained based on the mean values from above precision assessment. The S/CO value of a control serum detected by new lot kit could be changed to that detected by old kit lot based on the factor of y2/y1. Therefore, the plotting on primary Levey-Jennings control chart could be continued. The within-run coefficient of variation CV of the ELISA method for control serum with 0.2, 0.5, 1.0, 2.0 and 5.0ng/ml HBsAg were 11.08%, 9.49%, 9.83%, 9.18% and 7.25%, respectively, and between-run CV were 13.25%, 14.03%, 15.11%, 13.29% and 9.92%. The linear regression equation with best correlation coefficient from a test at random was y = 3.509x + 0.180. The suitable concentration of control serum for IQC could be 0.5ng/ml or 1.0ng/ml. The linear regression equation from the old lot and other two new lots of the ELISA kits were y1 = 3.550(x1) + 0.226, y2 = 3.238(x2) +0.388, and y3 =3.428(x3) + 0.148, respectively. Then, the transferring factors of 0.960 (y2/y1) and 0.908 (y3/y1) were obtained. The results shows that the model established for IQC control serum concentration selecting and for consecutive plotting on control chart when the reagent lot is changed is effective and practical.

  6. Lack of evidence for the presence of emerging HoBi-like viruses in North American fetal bovine serum lots.

    USDA-ARS?s Scientific Manuscript database

    The detection of HoBi-like virus in fetal bovine serum (FBS) labeled as United States of America (USA) origin, but packaged in Europe, raised concerns that HoBi-like virus may have entered the USA. In this study, 90 lots of FBS originating in North America (NA) were screened for pestivirus antigen ...

  7. Immune responses to a recombinant, four-component, meningococcal serogroup B vaccine (4CMenB) in adolescents: a phase III, randomized, multicentre, lot-to-lot consistency study.

    PubMed

    Perrett, Kirsten P; McVernon, Jodie; Richmond, Peter C; Marshall, Helen; Nissen, Michael; August, Allison; Percell, Sandra; Toneatto, Daniela; Nolan, Terry

    2015-09-22

    For decades, a broadly effective vaccine against serogroup B Neisseria meningitidis (MenB) has remained elusive. Recently, a four-component recombinant vaccine (4CMenB) has been developed and is now approved in Europe, Canada, Australia and some Latin American countries. This phase III, randomized study evaluated the lot consistency, early immune responses and the safety profile of 4CMenB in 11 to 17-year-old adolescents in Australia and Canada (NCT01423084). In total, 344 adolescents received two doses of one of 2 lots of 4CMenB, 1-month apart. Immunogenicity was assessed before, 2-weeks and 1-month following the second vaccination. Serum bactericidal activity using human complement (hSBA) was measured against three reference strains 44/76-SL, 5/99 and NZ98/254, selected to express one of the vaccine antigens; Neisseria adhesin A (NadA), factor H binding protein (fHbp) and porin A (PorA) containing outer membrane vesicle (OMV), respectively. Responses to the Neisseria heparin binding antigen (NHBA) were assessed with enzyme linked immunosorbent assay (ELISA). Local and systemic reactions were recorded for 7 days following each vaccination; unsolicited adverse events were monitored throughout the study. Immunological equivalence of the two lots of 4CMenB was established at 1-month. At baseline, ≤7% of participants had hSBA titers ≥5 to all three reference strains. Two weeks following the second dose of 4CMenB, all participants had hSBA titers ≥5 against fHbp and NadA compared with 84-96% against the PorA reference strains. At 1-month, corresponding proportions were 99%, 100% and 70-79%, respectively. Both lots were generally well tolerated and had similar adverse event profiles. Two doses of 4CMenB had an acceptable safety profile and induced a robust immune response in adolescents. Peak antibody responses were observed at 14 days following vaccination. While a substantial non-uniform antigen-dependent early decline in antibody titers was seen thereafter, a significant percentage of participants continued to maintain protective hSBA titers at 1-month. Copyright © 2015 Elsevier Ltd. All rights reserved.

  8. Reassessment of the Access Testosterone chemiluminescence assay and comparison with LC-MS method.

    PubMed

    Dittadi, Ruggero; Matteucci, Mara; Meneghetti, Elisa; Ndreu, Rudina

    2018-03-01

    To reassess the imprecision and Limit of Quantitation, to evaluate the cross-reaction with dehydroepiandrosterone-sulfate (DHEAS), the accuracy toward liquid chromatography-mass spectrometry (LC-MS) and the reference interval of the Access Testosterone method, performed by DxI immunoassay platform (Beckman Coulter). Imprecision was evaluated testing six pool samples assayed in 20 different run using two reagents lots. The cross-reaction with DHEAS was studied both by a displacement curve and by spiking DHEAS standard in two serum samples with known amount of testosterone. The comparison with LC-MS was evaluated by Passing-Bablock analysis in 21 routine serum samples and 19 control samples from an External Quality Assurance (EQA) scheme. The reference interval was verified by an indirect estimation on 2445 male and 2838 female outpatients. The imprecision study showed a coefficient of variation (CV) between 2.7% and 34.7% for serum pools from 16.3 and 0.27 nmol/L. The value of Limit of Quantitation at 20% CV was 0.53 nmol/L. The DHEAS showed a cross-reaction of 0.0074%. A comparison with LC-MS showed a trend toward a slight underestimation of immunoassay vs LC-MS (Passing-Bablock equations: DxI=-0.24+0.906 LCMS in serum samples and DxI=-0.299+0.981 LCMS in EQA samples). The verification of reference interval showed a 2.5th-97.5th percentile distribution of 6.6-24.3 nmol/L for male over 14 years and <0.5-2.78 nmol/L for female subjects, in accord with the reference intervals reported by the manufacturer. The Access Testosterone method could be considered an adequately reliable tool for the testosterone measurement. © 2017 Wiley Periodicals, Inc.

  9. Lack of evidence for the presence of emerging HoBi-like viruses in North American fetal bovine serum lots.

    PubMed

    Bauermann, Fernando V; Flores, Eduardo F; Falkenberg, Shollie M; Weiblen, Rudi; Ridpath, Julia F

    2014-01-01

    The detection of an emerging pestivirus species, "HoBi-like virus," in fetal bovine serum (FBS) labeled as U.S. origin, but packaged in Europe, raised concerns that HoBi-like virus may have entered the United States. In the current study, 90 lots of FBS originating in North America (NA) were screened for pestivirus antigen and antibodies. Lots in group 1 (G1, 72 samples) and group 2 (G2, 9 samples) originated in NA and were packaged in the United States. Group 3 (G3) was composed of 9 lots collected in NA and processed in Europe. Lots in G1 were claimed negative for Bovine viral diarrhea virus (BVDV), while lots in G2 and G3 were claimed positive by the commercial processor. All lots in G1 and G2 tested negative by reverse transcription polymerase chain reaction (RT-PCR) using HoBi-like-specific primers. Two G1 lots tested positive by BVDV RT-PCR. One of these was also positive by virus isolation. All G2 lots were positive by BVDV RT-PCR. In addition, four G2 lots were VI positive while 1 lot was antigen-capture enzyme-linked immunosorbent assay (ELISA) positive. Two G3 lots were positive by HoBi-like-specific RT-PCR tests. All lots were negative for HoBi_D32/00 neutralizing antibodies. Seven lots (4 G1; 1 G2; 2 G3) had antibodies against BVDV by virus neutralization and/or antigen-capture ELISA. While there is no evidence of HoBi-like viruses in NA based on tested samples, further studies are required to validate HoBi-like virus-free status and develop means to prevent the spread of HoBi-like virus into NA.

  10. Evaluation of a computer-assisted, kinetics-based enzyme-linked immunosorbent assay for detection of coronavirus antibodies in cats.

    PubMed Central

    Barlough, J E; Jacobson, R H; Downing, D R; Marcella, K L; Lynch, T J; Scott, F W

    1983-01-01

    A computer-assisted, kinetics-based enzyme-linked immunosorbent assay was adapted for the detection of coronavirus antibodies in feline serum. An alkaline antigen diluent (carbonate-bicarbonate buffer, pH 9.6) used in initial experiments produced diffuse, nonspecific color reactions in both viral and control antigen cuvettes which were correlated, paradoxically, with coronavirus antibody levels in test sera. These interfering reactions were minimized by use of lower-pH antigen diluents such as water and phosphate-buffered saline. Background kinetics-based enzyme-linked immunosorbent assay reactivity directed against a noncoronaviral component of antigen tissue culture fluids could then detected in numerous sera, particularly in samples with lower titers. Much of this reactivity was shown to be associated with bovine gamma globulins in cell culture fluid. It was not serum lot or species specific, since a variety of bovine serum lots as well as individual lots of serum from other mammalian and avian species reacted. Reactivity was markedly reduced when cells for antigen preparation were grown in gamma globulin-free bovine serum. Generation of corrected slope values from the kinetics-based enzyme-linked immunosorbent assay made it possible to correct for residual background reactivity in individual test sera and thus eliminate a potentially major source of false-positive reactions. Collectively, these studies indicated that the control of nonspecific reactivity in feline coronavirus serology is absolutely essential to obtain useful estimates of specific antibody responses. PMID:6300184

  11. Evaluation of a computer-assisted, kinetics-based enzyme-linked immunosorbent assay for detection of coronavirus antibodies in cats.

    PubMed

    Barlough, J E; Jacobson, R H; Downing, D R; Marcella, K L; Lynch, T J; Scott, F W

    1983-02-01

    A computer-assisted, kinetics-based enzyme-linked immunosorbent assay was adapted for the detection of coronavirus antibodies in feline serum. An alkaline antigen diluent (carbonate-bicarbonate buffer, pH 9.6) used in initial experiments produced diffuse, nonspecific color reactions in both viral and control antigen cuvettes which were correlated, paradoxically, with coronavirus antibody levels in test sera. These interfering reactions were minimized by use of lower-pH antigen diluents such as water and phosphate-buffered saline. Background kinetics-based enzyme-linked immunosorbent assay reactivity directed against a noncoronaviral component of antigen tissue culture fluids could then detected in numerous sera, particularly in samples with lower titers. Much of this reactivity was shown to be associated with bovine gamma globulins in cell culture fluid. It was not serum lot or species specific, since a variety of bovine serum lots as well as individual lots of serum from other mammalian and avian species reacted. Reactivity was markedly reduced when cells for antigen preparation were grown in gamma globulin-free bovine serum. Generation of corrected slope values from the kinetics-based enzyme-linked immunosorbent assay made it possible to correct for residual background reactivity in individual test sera and thus eliminate a potentially major source of false-positive reactions. Collectively, these studies indicated that the control of nonspecific reactivity in feline coronavirus serology is absolutely essential to obtain useful estimates of specific antibody responses.

  12. Development of an Accelerated Hydrogen Embrittlement Test for Manganese Phosphated Steels

    DTIC Science & Technology

    2011-05-01

    from the same vendor (RSL Testing Systems) and lot (HT/ HTP ) were used. See Appendix B for the certifications for lots HT/ HTP . Note: lot HTP is...Based on the vendor certification of the notched tensile specimens from RSL lot HT/ HTP , the NTS was 373 ksi and the average load at failure was...Systems Lot HT/ HTP ). Note that use of a higher reference NTS and load to failure is a conservative approach since the specimens will experience

  13. Biosynthesis of Beta-Nitropropionic Acid and Its Esterification to Cellulose.

    DTIC Science & Technology

    1987-06-10

    A-9128 D-amino acid oxidase, Lot # 14 F 2) No. B-2252 bromelain , Lot # 113-F-0585 3) No. E-3128 carboxyl esterase, Lot # 34-F-8110 4) No. C-2770...Substrate pH method (U/G) Bromelain NPAME 6.3 HPLC 0 Bovine serum Albumen 7.5 0 Carboxyl Esterase ENA 8.5 Spectral 1370 8.0 1400 7.5 1840 7.0 1980 I...34 "’a’" .. -6". Table 6. Conditions for preparation of semisynthetic enzymes Enzyme Modifier Cross-linker 0.b mg/ml Bromelaine 5 mM NP 1.5 mM DS 1.5 mM

  14. Evapotranspiration from selected fallowed agricultural fields on the Tule Lake National Wildlife Refuge, California, during May to October 2000

    USGS Publications Warehouse

    Bidlake, W.R.

    2002-01-01

    An investigation of evapotranspiration, vegetation quantity and composition, and depth to the water table below the land surface was made at three sites in two fallowed agricultural lots on the 15,800-hectare Tule Lake National Wildlife Refuge in northern California during the 2000 growing season. All three sites had been farmed during 1999, but were not irrigated since the 1999 growing season. Vegetation at the lot C1B and lot 6 stubble sites included weedy species and small grain plants. The lot 6 cover crop site supported a crop of cereal rye that had been planted during the previous winter. Percentage of coverage by live vegetation ranged from 0 to 43.2 percent at the lot C1B site, from approximately 0 to 63.2 percent at the lot 6 stubble site, and it was estimated to range from 0 to greater than 90 percent at the lot 6 cover crop site. Evapotranspiration was measured using the Bowen ratio energy balance technique and it was estimated using a model that was based on the Priestley-Taylor equation and a model that was based on reference evapotranspiration with grass as the reference crop. Total evapotranspiration during May to October varied little among the three evapotranspiration measurement sites, although the timing of evapotranspiration losses did vary among the sites. Total evapotranspiration from the lot C1B site was 426 millimeters, total evapotranspiration from the lot 6 stubble site was 444 millimeters, and total evapotranspiration from the lot 6 cover crop site was 435 millimeters. The months of May to July accounted for approximately 78 percent of the total evapotranspiration from the lot C1B site, approximately 63 percent of the evapotranspiration from the lot 6 stubble site, and approximately 86 percent of the total evapotranspiration from the lot 6 cover crop site. Estimated growing season precipitation accounted for 16 percent of the growing-season evapotranspiration at the lot C1B site and for 17 percent of the growing-season evapotranspiration at the lot 6 stubble and cover crop sites. The ratio of evapotranspiration rate to the reference evapotranspiration rate was strongly correlated with percentage of site coverage by vegetation at the lot C1B and lot 6 stubble sites (correlation coefficient = 0.95, sample size = 6), where percentage of site coverage was determined from quantitative vegetation surveys. It is concluded that evapotranspiration was mediated by the vegetation at all three sites, and that the differences in seasonal timing of evapotranspiration losses were caused by differences in timing of vegetation growth and development and senescence among the sites. Depth to the water table below the land surface at lot C1B ranged from 0.67 meters in early July to greater than 1.39 meters in late August. Depth to the water table at lot 6 ranged from 0.77 meter in late May to greater than 1.40 meters in late August.

  15. [Evaluation of contamination of serum derived intravenous preparations].

    PubMed

    Aleksandrowicz, J; Fiejka, M; Słowikowska, M

    1994-01-01

    The concentration of Al in 4 lots of 5% Albumina and in 14 lots of 5% immunoglobulins were estimated by adsorptive stripping voltammetric method. Mean Al concentrations amounted to 142.6 micrograms/l in 5% Albumina and to 202 micrograms/l in IVIG preparations produced in Poland. Al concentrations in foreign IVIG preparations ranged from 14 to 54 micrograms/l. These data show the need to consider setting an upper limit of microgram Al/l in i.v. drug products produced or registered in Poland.

  16. Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials.

    PubMed

    Vesikari, Timo; Esposito, Susanna; Prymula, Roman; Ypma, Ellen; Kohl, Igor; Toneatto, Daniela; Dull, Peter; Kimura, Alan

    2013-03-09

    Meningococcal serogroup B disease disproportionately affects infants. We assessed lot-to-lot consistency, safety and immunogenicity, and the effect of concomitant vaccination on responses to routine vaccines of an investigational multicomponent vaccine (4CMenB) in this population. We did primary and booster phase 3 studies between March 31, 2008, and Aug 16, 2010, in 70 sites in Europe. We used two series of sponsor-supplied, computer-generated randomisation envelopes to allocate healthy 2 month-old infants to receive routine vaccinations (diphtheria-tetanus-acellular pertussis, inactivated poliovirus, hepatitis B plus Haemophilus influenzae type b, and seven-valent pneumococcal vaccine) at 2, 4, and 6 months of age alone, or concomitantly with 4CMenB or serogroup C conjugate vaccine (MenC) in: 1) an open-label, lot-to-lot immunogenicity and safety substudy of three 4CMenB lots compared with routine vaccines alone (1:1:1:1, block size eight); or 2) an observer-blind, lot-to-lot safety substudy of three 4CMenB lots compared with MenC (1:1:1:3, block size six). At 12 months, 4CMenB-primed children from either substudy were randomised (1:1, block size two) to receive 4CMenB booster, with or without measles-mumps-rubella-varicella (MMRV) vaccine. Immunogenicity was assessed by serum bactericidal assay with human complement (hSBA) against serogroup B test strains, and on randomly selected subsets of serum samples for routine vaccines; laboratory personnel were masked to assignment. The first coprimary outcome was lot-to-lot consistency (hSBA geometric mean ratio of all lots between 0·5 and 2·0), and the second was an immune response (hSBA titre ≥5) for each of the three strains. The primary outcome for the booster study was immune response to booster dose. Immunogenicity data for 4CMenB were for the modified intention-to-treat population, including all infants from the open-label substudy who provided serum samples. The safety population included all participants who contributed safety data after at least one dose of study vaccine. These trials are registered with ClinicalTrials.gov, numbers NCT00657709 and NCT00847145. We enrolled 2627 infants in the open-label phase, 1003 in the observer-blind phase, and 1555 in the booster study. Lot-to-lot consistency was shown for the three 4CMenB lots, with the lowest 95% lower confidence limit being 0·74 and the highest upper limit being 1·33. Of 1181–1184 infants tested 1 month after three 4CMenB doses (all lots pooled), 100% (95% CI 99–100) had hSBA titres of 5 or more against strains selective for factor H binding protein and neisserial adhesin A, and 84% (82–86) for New Zealand outer-membrane vesicle. In a subset (n=100), 84% (75–91) of infants had hSBA titres of 5 or more against neisseria heparin binding antigen. At 12 months of age, waning titres were boosted by a fourth dose, such that 95–100% of children had hSBA titres of 5 or more for all antigens, with or without concomitant MMRV. Immune responses to routine vaccines were much the same with or without concomitant 4CMenB, but concomitant vaccination was associated with increased reactogenicity. 77% (1912 of 2478) of infants had fever of 38·5°C or higher after any 4CMenB dose, compared with 45% (295 of 659) after routine vaccines alone and 47% (228 of 490) with MenC, but only two febrile seizures were deemed probably related to 4CMenB. 4CMenB is immunogenic in infants and children aged 12 months with no clinically relevant interference with routine vaccines, but increases reactogenicity when administered concomitantly with routine vaccines. This breakthrough vaccine offers an innovative solution to the major remaining cause of bacterial meningitis in infant and toddlers. Novartis Vaccines and Diagnostics.

  17. Platelet lysate as replacement for fetal bovine serum in mesenchymal stromal cell cultures.

    PubMed

    Bieback, Karen

    2013-10-01

    Mesenchymal stromal cells (MSC) emerged as highly attractive in cell-based regenerative medicine. Initially thought to provide cells capable of differentiation towards mesenchymal cell types (osteoblasts, chondrocytes, adipocytes etc.), by and by potent immunoregulatory and pro-regenerative activities have been discovered, broadening the field of potential applications from bone and cartilage regeneration to wound healing and treatment of autoimmune diseases. Due to the limited frequency in most tissue sources, ex vivo expansion of MSC is required compliant with good manufacturing practice (GMP) guidelines to yield clinically relevant cell doses. Though, still most manufacturing protocols use fetal bovine serum (FBS) as cell culture supplement to isolate and to expand MSC. However, the high lot-to-lot variability as well as risk of contamination and immunization call for xenogenic-free culture conditions. In terms of standardization, chemically defined media appear as the ultimate achievement. Since these media need to maintain all key cellular and therapy-relevant features of MSC, the development of chemically defined media is still - albeit highly investigated - only in its beginning. The current alternatives to FBS rely on human blood-derived components: plasma, serum, umbilical cord blood serum, and platelet derivatives like platelet lysate. Focusing on quality aspects, the latter will be addressed within this review.

  18. Platelet Lysate as Replacement for Fetal Bovine Serum in Mesenchymal Stromal Cell Cultures

    PubMed Central

    Bieback, Karen

    2013-01-01

    Summary Mesenchymal stromal cells (MSC) emerged as highly attractive in cell-based regenerative medicine. Initially thought to provide cells capable of differentiation towards mesenchymal cell types (osteoblasts, chondrocytes, adipocytes etc.), by and by potent immunoregulatory and pro-regenerative activities have been discovered, broadening the field of potential applications from bone and cartilage regeneration to wound healing and treatment of autoimmune diseases. Due to the limited frequency in most tissue sources, ex vivo expansion of MSC is required compliant with good manufacturing practice (GMP) guidelines to yield clinically relevant cell doses. Though, still most manufacturing protocols use fetal bovine serum (FBS) as cell culture supplement to isolate and to expand MSC. However, the high lot-to-lot variability as well as risk of contamination and immunization call for xenogenic-free culture conditions. In terms of standardization, chemically defined media appear as the ultimate achievement. Since these media need to maintain all key cellular and therapy-relevant features of MSC, the development of chemically defined media is still – albeit highly investigated – only in its beginning. The current alternatives to FBS rely on human blood-derived components: plasma, serum, umbilical cord blood serum, and platelet derivatives like platelet lysate. Focusing on quality aspects, the latter will be addressed within this review. PMID:24273486

  19. Opsonic and protective activity of immunoglobulin, modified immunoglobulin, and serum against neonatal Escherichia coli K1 infection.

    PubMed

    Bortolussi, R; Fischer, G W

    1986-02-01

    Because modified immune serum globulin (M-ISG) has been proposed for therapy in neonatal bacterial sepsis, we evaluated it in a suckling rat model of Escherichia coli K1 sepsis. We compared a M-ISG preparation (lot 2581), which was protective against group B streptococcal (GBS) sepsis, with other M-ISG, standard ISG preparations and with adult and cord serum. All immune serum preparations and sera demonstrated opsonic activity against E. coli K1 and were superior to saline in protecting against death due to E. coli K1 sepsis. Survival rates were higher for one M-ISG preparation (lot 2581) than for randomly selected standard immune serum globulin and cord sera but were similar to adult sera in these protection studies. Therapeutic and opsonic activity of standard immune serum globulin and M-ISG prepared from the same donors were similar, suggesting that the different processes used for their manufacture did not affect these activities. Because the M-ISG preparation studied showed protective activity to both GBS and E. coli K1, we studied it further by adsorbing the preparation with GBS and E. coli K1. Opsonic activity to E. coli K1 was removed by E. coli adsorption but not by adsorption with GBS, indicating that this activity was not due to a single cross-reacting antibody. Empirical therapy with M-ISG prescreened for opsonic activity to both E. coli K1 and GBS may be of clinical value. Trials appear warranted to study the pharmacology and efficacy of M-ISG in septic newborns.

  20. Patient-Specific Induced Pluripotent Stem Cell Models: Generation and Characterization of Cardiac Cells.

    PubMed

    Zanella, Fabian; Sheikh, Farah

    2016-01-01

    The generation of human induced pluripotent stem cell (hiPSC)-derived cardiomyocytes has been of utmost interest for the study of cardiac development, cardiac disease modeling, and evaluation of cardiotoxic effects of novel candidate drugs. Several protocols have been developed to guide human stem cells toward the cardiogenic path. Pioneering work used serum to promote cardiogenesis; however, low cardiogenic throughputs, lack of chemical definition, and batch-to-batch variability of serum lots constituted a considerable impediment to the implementation of those protocols to large-scale cell biology. Further work focused on the manipulation of pathways that mouse genetics indicated to be fundamental in cardiac development to promote cardiac differentiation in stem cells. Although extremely elegant, those serum-free protocols involved the use of human recombinant cytokines that tend to be quite costly and which can also be variable between lots. The latest generation of cardiogenic protocols aimed for a more cost-effective and reproducible definition of the conditions driving cardiac differentiation, using small molecules to manipulate cardiogenic pathways overriding the need for cytokines. This chapter details methods based on currently available cardiac differentiation protocols for the generation and characterization of robust numbers of hiPSC-derived cardiomyocytes under chemically defined conditions.

  1. Determination of supplier-to-supplier and lot-to-lot variability in glycation of recombinant human serum albumin expressed in Oryza sativa.

    PubMed

    Frahm, Grant E; Smith, Daryl G S; Kane, Anita; Lorbetskie, Barry; Cyr, Terry D; Girard, Michel; Johnston, Michael J W

    2014-01-01

    The use of different expression systems to produce the same recombinant human protein can result in expression-dependent chemical modifications (CMs) leading to variability of structure, stability and immunogenicity. Of particular interest are recombinant human proteins expressed in plant-based systems, which have shown particularly high CM variability. In studies presented here, recombinant human serum albumins (rHSA) produced in Oryza sativa (Asian rice) (OsrHSA) from a number of suppliers have been extensively characterized and compared to plasma-derived HSA (pHSA) and rHSA expressed in yeast (Pichia pastoris and Saccharomyces cerevisiae). The heterogeneity of each sample was evaluated using size exclusion chromatography (SEC), reversed-phase high-performance liquid chromatography (RP-HPLC) and capillary electrophoresis (CE). Modifications of the samples were identified by liquid chromatography-mass spectrometry (LC-MS). The secondary and tertiary structure of the albumin samples were assessed with far U/V circular dichroism spectropolarimetry (far U/V CD) and fluorescence spectroscopy, respectively. Far U/V CD and fluorescence analyses were also used to assess thermal stability and drug binding. High molecular weight aggregates in OsrHSA samples were detected with SEC and supplier-to-supplier variability and, more critically, lot-to-lot variability in one manufactures supplied products were identified. LC-MS analysis identified a greater number of hexose-glycated arginine and lysine residues on OsrHSA compared to pHSA or rHSA expressed in yeast. This analysis also showed supplier-to-supplier and lot-to-lot variability in the degree of glycation at specific lysine and arginine residues for OsrHSA. Both the number of glycated residues and the degree of glycation correlated positively with the quantity of non-monomeric species and the chromatographic profiles of the samples. Tertiary structural changes were observed for most OsrHSA samples which correlated well with the degree of arginine/lysine glycation. The extensive glycation of OsrHSA from multiple suppliers may have further implications for the use of OsrHSA as a therapeutic product.

  2. [Characterization and comparison of interferon reference standards using UPLC-MS].

    PubMed

    Tao, Lei; Pei, De-ning; Han, Chun-mei; Chen, Wei; Rao, Chun-ming; Wang, Jun-zhi

    2015-01-01

    The study aims to characterize and compare interferon reference standards from 5 manufacturers. By testing molecular mass and trypsin-digested peptide mass mapping, the amino acid sequence was verified and post-translational modifications such as disulfide bond were identified. Results show that the molecular mass and amino acid sequence were consistent with theory; the disulfide bonds of 4 lots of interferon were Cys1-Cys98/Cys29-Cys138, 1 lot was Cys29-Cys139/Cys86-Cys99; N-terminal "+Met", acetyl N-terminal and Met oxidation were identified in part of the sample. UPLC-MS can be used to characterize and compare interferon reference standards from different manufacturers.

  3. The processing and collaborative assay of a reference endotoxin.

    PubMed

    Hochstein, H D; Mills, D F; Outschoorn, A S; Rastogi, S C

    1983-10-01

    A preparation of Escherichia coli bacterial endotoxin, the latest of successive lots drawn from bulk material which has been studied in laboratory tests and in animals and humans for suitability as a reference endotoxin, has been filled and lyophilized in a large number of vials. Details of its characterization, including stability studies, are given. A collaborative assay was conducted by 14 laboratories using gelation end-points with Limulus amebocyte lysates. Approximate continuity of the unit of potency with the existing national unit was achieved. The lot was made from the single final bulk but had to be freeze-dried in five sublimators. An assessment was therefore made for possible heterogeneity. The results indicate that the lot can be used as a large homogeneous quantity. The advantages of using it widely as a standard for endotoxins are discussed.

  4. Negative Effects of Learning Spreadsheet Management on Learning Database Management

    ERIC Educational Resources Information Center

    Vágner, Anikó; Zsakó, László

    2015-01-01

    A lot of students learn spreadsheet management before database management. Their similarities can cause a lot of negative effects when learning database management. In this article, we consider these similarities and explain what can cause problems. First, we analyse the basic concepts such as table, database, row, cell, reference, etc. Then, we…

  5. Research on effect of ginkgo aglucone flavone to human body organs and immune function.

    PubMed

    Wang, Xiong

    2014-07-01

    Ginkgo aglucone flavone is a kind of effective natural antioxidant. Lots of researches show that ginkgo aglucone flavone has various biological activities and it is of great importance to antioxidant, anti-aging, free radial scavenging and immunoregulation. However, researches on effect of ginkgo aglucone flavone to immune function are rare so far. Thus, it is important to go into the effect of ginkgo aglucone flavone to immune function. We can find out more effective measurement that resist immunosuppression through research and provide referable science activity form and suggestion of sports nutrition supplements. It can guide people to improve habitus through supports and establish important basis for new area development of folium ginkgo extract. This paper aims to discuss the effect of ginkgo aglucone flavone to human body organs and immune function. Patients with ginkgo aglucone flavone indications are selected for experiment. Their peripheral blood T lymphocyte subsets and content of serum immunoglobin is detected before and two weeks after drug use. The result shows that specific ratio of T lymphocyte subsets CD3 and CD4 and the content of serum IgG significantly increase after pharmacy of patients. It can be concluded that ginkgo aglucone flavone have acceleration on immune system function.

  6. Suppression of humoral response during the course of Candida albicans infection in mice.

    PubMed

    Valdez, J C; Meson, O E; de Valdez, G A; Sirena, A

    1984-10-30

    This paper aims at demonstrating the non-specific immunosuppression as regards thyme-dependent antigens sheep erythrocytes (SRBC) during the course of Candida albicans systemic infection. Three lots of syngeneic/BALB/c mice, 8-12 weeks of age, were used. The first normal lot was inoculated via the intraperitoneal route with a (SRBC) suspension (4 X 10(8) cells ml) in a Hank's balanced saline solution. The primary response of antibodies formed by splenic cells was measured from 4 to 8 days after inoculation using the direct plaque forming cells technique. The second lot was infected by the same route with a suspension of Candida albicans (1 X 10(7) cells). Positive retrocultures from the blood and kidneys of these infected mice were obtained. These yeasts cultivated in a Sabouraud medium were harvested after 20 h at 37 degrees C. Following the same methodology the immune response to SRBC was determined. The serum obtained from infected mice was transferred to a third lot of mice at different intervals during the course of the infection. The immune response to SRBC was done by the direct plaque-forming cells technique. Controls were carried out using normal donors and recipients. A suppression of the immune response was obtained as from the 2nd day of inoculation up to the 28th day. It was not possible to transfer such suppression passively by means of the serum. These results suggest that the systemic infection by Candida albicans induce a non-specific immunosuppression in the organism, already demonstrated in viral infections, bacteria, protozoaria and metazoaria in mammals. In some way, this will contribute to explain the mechanisms of immune response to Candida albicans.

  7. 40 CFR 52.128 - Rule for unpaved parking lots, unpaved roads and vacant lots.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... where the exemption in paragraph (c)(2) of this section applies. (9) Motor vehicle—A self-propelled.... Research Triangle Park, N.C. May 1982. 3. “Method 9—Visible Determination of the Opacity of Emissions from... of the human eye—Reference 4.1 of section 4.) c. Angle of view 15 degrees maximum total angle d...

  8. 40 CFR 52.128 - Rule for unpaved parking lots, unpaved roads and vacant lots.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... where the exemption in paragraph (c)(2) of this section applies. (9) Motor vehicle—A self-propelled.... Research Triangle Park, N.C. May 1982. 3. “Method 9—Visible Determination of the Opacity of Emissions from... of the human eye—Reference 4.1 of section 4.) c. Angle of view 15 degrees maximum total angle d...

  9. 40 CFR 52.128 - Rule for unpaved parking lots, unpaved roads and vacant lots.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    .... Research Triangle Park, N.C. May 1982. 3. “Method 9—Visible Determination of the Opacity of Emissions from... other dust generating operations which have been terminated for over eight months. (3) The test methods... than or equal to a nominal 10 micrometers as measured by reference or equivalent methods that meet the...

  10. 40 CFR 52.128 - Rule for unpaved parking lots, unpaved roads and vacant lots.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    .... Research Triangle Park, N.C. May 1982. 3. “Method 9—Visible Determination of the Opacity of Emissions from... other dust generating operations which have been terminated for over eight months. (3) The test methods... than or equal to a nominal 10 micrometers as measured by reference or equivalent methods that meet the...

  11. 40 CFR 52.128 - Rule for unpaved parking lots, unpaved roads and vacant lots.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    .... Research Triangle Park, N.C. May 1982. 3. “Method 9—Visible Determination of the Opacity of Emissions from... other dust generating operations which have been terminated for over eight months. (3) The test methods... than or equal to a nominal 10 micrometers as measured by reference or equivalent methods that meet the...

  12. Molecular and phenotypic analysis of a working seed lot of yellow fever virus 17DD vaccine strain produced from the secondary seed lot 102/84 with an additional passage in chicken embryos.

    PubMed

    Marchevsky, Renato S; da Luz Leal, Maria; Homma, Akira; Coutinho, Evandro S F; Camacho, Luis A B; Jabor, Alfredo V; Galler, Ricardo; Freire, Marcos S

    2006-09-01

    Over the last 17 years, the yellow fever (YF) 17DD vaccine secondary seed lot 102/84 was used to produce many million doses of vaccine but it was recently used up. In the absence of other lots at the same passage level a large vaccine batch produced from 102/84 was turned into a new working seed. This new seed was characterized with regard to attenuation in the recommended internationally accepted monkey neurovirulence test (MNVT) using the 102/84 virus as reference. All rhesus monkeys (Macaca mulatta) developed limited viremia and comparable neutralizing antibody titers. Clinical evaluation and histological examination of the central nervous system (CNS) according to WHO criteria for acceptability gave consistent data that demonstrated an attenuated phenotype for the YF 17DD 993FB013Z (13Z) vaccine batch. It is concluded that the additional chicken embryo passage did not lead to any genetic change and the new working seed virus retained its attenuation for monkeys comparable to the 102/84 reference virus.

  13. Reproducibility of polycarbonate reference material in toxicity evaluation

    NASA Technical Reports Server (NTRS)

    Hilado, C. J.; Huttlinger, P. A.

    1981-01-01

    A specific lot of bisphenol A polycarbonate has been used for almost four years as the reference material for the NASA-USF-PSC toxicity screening test method. The reproducibility of the test results over this period of time indicate that certain plastics may be more suitable reference materials than the more traditional cellulosic materials.

  14. A survey of the concentrations of eleven metals in vaccines, allergenic extracts, toxoids, blood, blood derivatives and other biological products.

    PubMed

    May, J C; Rains, T C; Maienthal, F J; Biddle, G N; Progar, J J

    1986-10-01

    Approximately 85 samples of injectable biological products regulated by the Center for Drugs and Biologics of the United States Food and Drug Administration were surveyed for the presence of 11 elements, namely aluminum, arsenic, barium, cadmium, chromium, lead, mercury, selenium, thallium and zinc, by flame and flameless methods of atomic absorption spectrometry and flame emission spectrometry. The range of products tested included whole blood, red cells, plasma, normal serum albumin, antihemophilic factor, and other products derived from blood; allergenic extracts including honey bee venom and house dust allergenic extracts; vaccines such as measles virus vaccine and typhoid vaccine; and tetanus toxoid. The metal concentrations found in the majority of these products were low or undetectable. The metal levels varied from manufacturer to manufacturer, product and lot-to-lot of the same manufacturer's products. House dust allergenic extracts had the highest concentrations of arsenic (2.4 ppm), cadmium (0.28 ppm), chromium (0.6 ppm) and lead (1.5 ppm) found in the study. A high zinc concentration (24 ppm) in an immune serum globulin was attributed to the zinc-containing rubber stopper in contact with the product. A range of 0.36-3.30 ppm aluminum was found for seven 25% normal serum albumin samples from seven manufacturers. Values of 8.2, 17 and 18 ppm aluminum were found in one manufacturer's 25% normal serum albumin. These aluminum values appeared to be the result of an anomaly in this manufacturer's production that has not been repeated to date.

  15. Drifts in ADCC-related quality attributes of Herceptin®: Impact on development of a trastuzumab biosimilar.

    PubMed

    Kim, Seokkyun; Song, Jinsu; Park, Seungkyu; Ham, Sunyoung; Paek, Kyungyeol; Kang, Minjung; Chae, Yunjung; Seo, Heewon; Kim, Hyung-Chan; Flores, Michael

    A biosimilar product needs to demonstrate biosimilarity to the originator reference product, and the quality profile of the latter should be monitored throughout the period of the biosimilar's development to match the quality attributes of the 2 products that relate to efficacy and safety. For the development of a biosimilar version of trastuzumab, the reference product, Herceptin®, was extensively characterized for the main physicochemical and biologic properties by standard or state-of-the-art analytical methods, using multiple lots expiring between March 2015 and December 2019. For lots with expiry dates up to July 2018, a high degree of consistency was observed for all the tested properties. However, among the lots expiring in August 2018 or later, a downward drift was observed in %afucose (G0+G1+G2). Furthermore, the upward drift of %high mannose (M5+M6) was observed in the lots with expiry dates from June 2019 to December 2019. As a result, the combination of %afucose and %high mannose showed 2 marked drifts in the lots with expiry dates from August 2018 to December 2019, which was supported by the similar trend of biologic data, such as FcγRIIIa binding and antibody-dependent cell-mediated cytotoxicity (ADCC) activity. Considering that ADCC is one of the clinically relevant mechanisms of action for trastuzumab, the levels of %afucose and %high mannose should be tightly monitored as critical quality attributes for biosimilar development of trastuzumab.

  16. Drifts in ADCC-related quality attributes of Herceptin®: Impact on development of a trastuzumab biosimilar

    PubMed Central

    Kim, Seokkyun; Song, Jinsu; Park, Seungkyu; Ham, Sunyoung; Paek, Kyungyeol; Kang, Minjung; Chae, Yunjung; Seo, Heewon; Kim, Hyung-Chan; Flores, Michael

    2017-01-01

    ABSTRACT A biosimilar product needs to demonstrate biosimilarity to the originator reference product, and the quality profile of the latter should be monitored throughout the period of the biosimilar's development to match the quality attributes of the 2 products that relate to efficacy and safety. For the development of a biosimilar version of trastuzumab, the reference product, Herceptin®, was extensively characterized for the main physicochemical and biologic properties by standard or state-of-the-art analytical methods, using multiple lots expiring between March 2015 and December 2019. For lots with expiry dates up to July 2018, a high degree of consistency was observed for all the tested properties. However, among the lots expiring in August 2018 or later, a downward drift was observed in %afucose (G0+G1+G2). Furthermore, the upward drift of %high mannose (M5+M6) was observed in the lots with expiry dates from June 2019 to December 2019. As a result, the combination of %afucose and %high mannose showed 2 marked drifts in the lots with expiry dates from August 2018 to December 2019, which was supported by the similar trend of biologic data, such as FcγRIIIa binding and antibody-dependent cell-mediated cytotoxicity (ADCC) activity. Considering that ADCC is one of the clinically relevant mechanisms of action for trastuzumab, the levels of %afucose and %high mannose should be tightly monitored as critical quality attributes for biosimilar development of trastuzumab. PMID:28296619

  17. Evaluation of Commercially Available Diagnostic Tests for the Detection of Dengue Virus NS1 Antigen and Anti-Dengue Virus IgM Antibody

    PubMed Central

    Hunsperger, Elizabeth A.; Yoksan, Sutee; Buchy, Philippe; Nguyen, Vinh Chau; Sekaran, Shamala Devi; Enria, Delia A.; Vazquez, Susana; Cartozian, Elizabeth; Pelegrino, Jose L.; Artsob, Harvey; Guzman, Maria G.; Olliaro, Piero; Zwang, Julien; Guillerm, Martine; Kliks, Susie; Halstead, Scott; Peeling, Rosanna W.; Margolis, Harold S.

    2014-01-01

    Commercially available diagnostic test kits for detection of dengue virus (DENV) non-structural protein 1 (NS1) and anti-DENV IgM were evaluated for their sensitivity and specificity and other performance characteristics by a diagnostic laboratory network developed by World Health Organization (WHO), the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) and the Pediatric Dengue Vaccine Initiative (PDVI). Each network laboratory contributed characterized serum specimens for the panels used in the evaluation. Microplate enzyme-linked immunosorbent assay (ELISA) and rapid diagnostic test (RDT formats) were represented by the kits. Each ELISA was evaluated by 2 laboratories and RDTs were evaluated by at least 3 laboratories. The reference tests for IgM anti-DENV were laboratory developed assays produced by the Armed Forces Research Institute for Medical Science (AFRIMS) and the Centers for Disease Control and Prevention (CDC), and the NS1 reference test was reverse transcriptase polymerase chain reaction (RT-PCR). Results were analyzed to determine sensitivity, specificity, inter-laboratory and inter-reader agreement, lot-to-lot variation and ease-of-use. NS1 ELISA sensitivity was 60–75% and specificity 71–80%; NS1 RDT sensitivity was 38–71% and specificity 76–80%; the IgM anti-DENV RDTs sensitivity was 30–96%, with a specificity of 86–92%, and IgM anti-DENV ELISA sensitivity was 96–98% and specificity 78–91%. NS1 tests were generally more sensitive in specimens from the acute phase of dengue and in primary DENV infection, whereas IgM anti-DENV tests were less sensitive in secondary DENV infections. The reproducibility of the NS1 RDTs ranged from 92-99% and the IgM anti-DENV RDTs from 88–94%. PMID:25330157

  18. On Statistical Approaches for Demonstrating Analytical Similarity in the Presence of Correlation.

    PubMed

    Yang, Harry; Novick, Steven; Burdick, Richard K

    Analytical similarity is the foundation for demonstration of biosimilarity between a proposed product and a reference product. For this assessment, currently the U.S. Food and Drug Administration (FDA) recommends a tiered system in which quality attributes are categorized into three tiers commensurate with their risk and approaches of varying statistical rigor are subsequently used for the three-tier quality attributes. Key to the analyses of Tiers 1 and 2 quality attributes is the establishment of equivalence acceptance criterion and quality range. For particular licensure applications, the FDA has provided advice on statistical methods for demonstration of analytical similarity. For example, for Tier 1 assessment, an equivalence test can be used based on an equivalence margin of 1.5 σ R , where σ R is the reference product variability estimated by the sample standard deviation S R from a sample of reference lots. The quality range for demonstrating Tier 2 analytical similarity is of the form X̄ R ± K × σ R where the constant K is appropriately justified. To demonstrate Tier 2 analytical similarity, a large percentage (e.g., 90%) of test product must fall in the quality range. In this paper, through both theoretical derivations and simulations, we show that when the reference drug product lots are correlated, the sample standard deviation S R underestimates the true reference product variability σ R As a result, substituting S R for σ R in the Tier 1 equivalence acceptance criterion and the Tier 2 quality range inappropriately reduces the statistical power and the ability to declare analytical similarity. Also explored is the impact of correlation among drug product lots on Type I error rate and power. Three methods based on generalized pivotal quantities are introduced, and their performance is compared against a two-one-sided tests (TOST) approach. Finally, strategies to mitigate risk of correlation among the reference products lots are discussed. A biosimilar is a generic version of the original biological drug product. A key component of a biosimilar development is the demonstration of analytical similarity between the biosimilar and the reference product. Such demonstration relies on application of statistical methods to establish a similarity margin and appropriate test for equivalence between the two products. This paper discusses statistical issues with demonstration of analytical similarity and provides alternate approaches to potentially mitigate these problems. © PDA, Inc. 2016.

  19. Reference interval for thyrotropin in a ultrasonography screened Korean population

    PubMed Central

    Kim, Mijin; Kim, Soo Han; Lee, Yunkyoung; Park, Su-yeon; Kim, Hyung-don; Kwon, Hyemi; Choi, Yun Mi; Jang, Eun Kyung; Jeon, Min Ji; Kim, Won Gu; Shong, Young Kee; Kim, Won Bae

    2015-01-01

    Background/Aims The diagnostic accuracy of thyroid dysfunctions is primarily affected by the validity of the reference interval for serum thyroid-stimulating hormone (TSH). Thus, the present study aimed to establish a reference interval for TSH using a normal Korean population. Methods This study included 19,465 subjects who were recruited after undergoing routine health check-ups. Subjects with overt thyroid disease, a prior history of thyroid disease, or a family history of thyroid cancer were excluded from the present analyses. The reference range for serum TSH was evaluated in a normal Korean reference population which was defined according to criteria based on the guidelines of the National Academy of Clinical Biochemistry, ultrasound (US) findings, and smoking status. Sex and age were also taken into consideration when evaluating the distribution of serum TSH levels in different groups. Results In the presence of positive anti-thyroid peroxidase antibodies or abnormal US findings, the central 95 percentile interval of the serum TSH levels was widened. Additionally, the distribution of serum TSH levels shifted toward lower values in the current smokers group. The reference interval for TSH obtained using a normal Korean reference population was 0.73 to 7.06 mIU/L. The serum TSH levels were higher in females than in males in all groups, and there were no age-dependent shifts. Conclusions The present findings demonstrate that the serum TSH reference interval in a normal Korean reference population was higher than that in other countries. This result suggests that the upper and lower limits of the TSH reference interval, which was previously defined by studies from Western countries, should be raised for Korean populations. PMID:25995664

  20. "Thinking a Lot" Among the Khwe of South Africa: A Key Idiom of Personal and Interpersonal Distress.

    PubMed

    den Hertog, T N; de Jong, M; van der Ham, A J; Hinton, D; Reis, R

    2016-09-01

    "Thinking too much", and variations such as "thinking a lot", are common idioms of distress across the world. The contextual meaning of this idiom of distress in particular localities remains largely unknown. This paper reports on a systematic study of the content and cause, consequences, and social response and coping related to the local terms |x'an n|a te and |eu-ca n|a te, both translated as "thinking a lot", and was part of a larger ethnographic study among the Khwe of South Africa. Semi-structured exploratory interviews with community members revealed that "thinking a lot" refers to a common experience of reflecting on personal and interpersonal problems. Consequences were described in emotional, psychological, social, behavioral, and physical effects. Coping strategies included social support, distraction, and religious practices. Our contextualized approach revealed meanings and experiences of "thinking a lot" that go beyond a psychological state or psychopathology. The common experience of "thinking a lot" is situated in socio-political, economic, and social context that reflect the marginalized and displaced position of the Khwe. We argue that "thinking a lot" and associated local meanings may vary across settings, may not necessarily indicate psychopathology, and should be understood in individual, interpersonal, community, and socio-political dimensions.

  1. Harmonising Reference Intervals for Three Calculated Parameters used in Clinical Chemistry.

    PubMed

    Hughes, David; Koerbin, Gus; Potter, Julia M; Glasgow, Nicholas; West, Nic; Abhayaratna, Walter P; Cavanaugh, Juleen; Armbruster, David; Hickman, Peter E

    2016-08-01

    For more than a decade there has been a global effort to harmonise all phases of the testing process, with particular emphasis on the most frequently utilised measurands. In addition, it is recognised that calculated parameters derived from these measurands should also be a target for harmonisation. Using data from the Aussie Normals study we report reference intervals for three calculated parameters: serum osmolality, serum anion gap and albumin-adjusted serum calcium. The Aussie Normals study was an a priori study that analysed samples from 1856 healthy volunteers. The nine analytes used for the calculations in this study were measured on Abbott Architect analysers. The data demonstrated normal (Gaussian) distributions for the albumin-adjusted serum calcium, the anion gap (using potassium in the calculation) and the calculated serum osmolality (using both the Bhagat et al. and Smithline and Gardner formulae). To assess the suitability of these reference intervals for use as harmonised reference intervals, we reviewed data from the Royal College of Pathologists of Australasia/Australasian Association of Clinical Biochemists (RCPA/AACB) bias survey. We conclude that the reference intervals for the calculated serum osmolality (using the Smithline and Gardner formulae) may be suitable for use as a common reference interval. Although a common reference interval for albumin-adjusted serum calcium may be possible, further investigations (including a greater range of albumin concentrations) are needed. This is due to the bias between the Bromocresol Green (BCG) and Bromocresol Purple (BCP) methods at lower serum albumin concentrations. Problems with the measurement of Total CO 2 in the bias survey meant that we could not use the data for assessing the suitability of a common reference interval for the anion gap. Further study is required.

  2. Immunoturbidimetric quantification of serum immunoglobulin G concentration in foals.

    PubMed

    Bauer, J E; Brooks, T P

    1990-08-01

    Immunoturbidimetric determination of serum IgG concentration in foals was compared with the reference methods of single radial immunodiffusion and serum protein electrophoresis. High positive correlations were discovered when the technique was compared with either of these reference methods. The zinc sulfate turbidity test for serum IgG estimation was also evaluated. Although a positive correlation was discovered when the latter method was compared with reference methods, it was not as strong as the correlation between reference methods and the immunoturbidimetric method. The immunoturbidimetric method used in this study is specific and precise for equine serum IgG determination. It is rapid and, thus, is advantageous when timely evaluation of critically ill foals is necessary. The technique should be adaptable to various spectrophotometers and microcomputers for widespread application in veterinary medicine.

  3. Paradigm Diagnostics Salmonella Indicator Broth (PDX-SIB) for detection of Salmonella on selected environmental surfaces.

    PubMed

    Olstein, Alan; Griffith, Leena; Feirtag, Joellen; Pearson, Nicole

    2013-01-01

    The Paradigm Diagnostics Salmonella Indicator Broth (PDX-SIB) is intended as a single-step selective enrichment indicator broth to be used as a simple screening test for the presence of Salmonella spp. in environmental samples. This method permits the end user to avoid multistep sample processing to identify presumptively positive samples, as exemplified by standard U.S. reference methods. PDX-SIB permits the outgrowth of Salmonella while inhibiting the growth of competitive Gram-negative and -positive microflora. Growth of Salmonella-positive cultures results in a visual color change of the medium from purple to yellow when the sample is grown at 37 +/- 1 degree C. Performance of PDX-SIB has been evaluated in five different categories: inclusivity-exclusivity, methods comparison, ruggedness, lot-to-lot variability, and shelf stability. The inclusivity panel included 100 different Salmonella serovars, 98 of which were SIB-positive during the 30 to 48 h incubation period. The exclusivity panel included 33 different non-Salmonella microorganisms, 31 of which were SIB-negative during the incubation period. Methods comparison studies included four different surfaces: S. Newport on plastic, S. Anatum on sealed concrete, S. Abaetetuba on ceramic tile, and S. Typhimurium in the presence of 1 log excess of Citrobacter freundii. Results of the methods comparison studies demonstrated no statistical difference between the SIB method and the U.S. Food and Drug Administration-Bacteriological Analytical Manual reference method, as measured by the Mantel-Haenszel Chi-square test. Ruggedness studies demonstrated little variation in test results when SIB incubation temperatures were varied over a 34-40 degrees C range. Lot-to-lot consistency results suggest no detectable differences in manufactured goods using two reference Salmonella serovars and one non-Salmonella microorganism.

  4. Lot-to-lot consistency of live attenuated SA 14-14-2 Japanese encephalitis vaccine manufactured in a good manufacturing practice facility and non-inferiority with respect to an earlier product.

    PubMed

    Zaman, K; Naser, Abu Mohd; Power, Maureen; Yaich, Mansour; Zhang, Lei; Ginsburg, Amy Sarah; Luby, Stephen P; Rahman, Mahmudur; Hills, Susan; Bhardwaj, Mukesh; Flores, Jorge

    2014-10-21

    We conducted a four-arm, double-blind, randomized controlled trial among 818 Bangladeshi infants between 10 and 12 months of age to establish equivalence among three lots of live attenuated SA 14-14-2 JE vaccine manufactured by the China National Biotec Group's Chengdu Institute of Biological Products (CDIBP) in a new Good Manufacturing Practice (GMP) facility and to evaluate non-inferiority of the product with a lot of the same vaccine manufactured in CDIBP's original facility. The study took place in two sites in Bangladesh, rural Matlab and Mirpur in urban Dhaka. We collected pre-vaccination (Day 0) and post-vaccination Day 28 (-4 to +14 days) blood samples to assess neutralizing anti-JE virus antibody titers in serum by plaque reduction neutralization tests (PRNT). Seroprotection following vaccination was defined as a PRNT titer ≥1:10 at Day 28 in participants non-immune at baseline. Follow-up for reactogenicity and safety was conducted through home visits at Day 7 and monitoring for serious adverse events through Day 28. Seroprotection rates ranged from 80.2% to 86.3% for all four lots of vaccine. Equivalence of the seroprotection rates between pairs of vaccine lots produced in the new GMP facility was satisfied at the pre-specified 10% margin of the 95% confidence interval (CI) for two of the three pairwise comparisons, but not for the third (-4.3% observed difference with 95% CI of -11.9 to 3.3%). Nevertheless, the aggregate seroprotection rate for all three vaccine lots manufactured in the GMP facility was calculated and found to be within the non-inferiority margin (within 10%) to the vaccine lot produced in the original facility. All four lots of vaccine were safe and well tolerated. These study results should facilitate the use of SA 14-14-2 JE vaccine as a routine component of immunization programs in Asian countries. Copyright © 2014 Elsevier Ltd. All rights reserved.

  5. Yellow fever vaccine: comparison of the neurovirulence of new 17D-204 Stamaril™ seed lots and RK 168-73 strain.

    PubMed

    Moulin, Jean-Claude; Silvano, Jérémy; Barban, Véronique; Riou, Patrice; Allain, Caroline

    2013-07-01

    The neurovirulence of two new candidate 17D-204 Stamaril™ working seed lots and that of two reference preparations were compared. The Stamaril™ working seed lots have been used for more than twenty years for the manufacturing of vaccines of acceptable safety and efficacy. The preparation designated RK 168-73 and provided by the Robert Koch Institute was used as a reference. It was confirmed that RK 168-73 strain was not a good virus control in our study because it has a very low neurovirulence regarding both the clinical and histopathological scores in comparison with Stamaril™ strain and is not representative of a vaccine known to be satisfactory in use. The results were reinforced by the phenotypic characterization by plaque assay demonstrating that RK 168-73 was very different from the Stamaril™ vaccine, and by sequencing results showing 4 mutations between Stamaril™ and RK 168-73 viruses leading to amino acid differences in the NS4B and envelop proteins. Copyright © 2013 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

  6. Age- and sex-specific reference limits for creatinine, cystatin C and the estimated glomerular filtration rate.

    PubMed

    Hannemann, Anke; Friedrich, Nele; Dittmann, Kathleen; Spielhagen, Christin; Wallaschofski, Henri; Völzke, Henry; Rettig, Rainer; Endlich, Karlhans; Lendeckel, Uwe; Stracke, Sylvia; Nauck, Matthias

    2011-11-14

    Early detection of patients with chronic kidney disease is of great importance. This study developed reference limits for serum creatinine and serum cystatin C concentrations and for the estimated glomerular filtration rate (eGFR) in healthy subjects from the general population aged 25-65 years. This study defined a reference population including 985 subjects from the first follow-up of the Study of Health in Pomerania. Serum creatinine was measured with a modified kinetic Jaffé method. Serum cystatin C was measured with a nephelometric assay. The eGFR was calculated from serum creatinine according to the Cockcroft-Gault (eGFR(CG)) and the Modification of Diet in Renal Disease (eGFR(MDRD)) equation, respectively, as well as from serum cystatin C according to the formula by Larsson (eGFR(Larsson)). Non-parametric quantile regression was used to estimate the reference limits. For serum creatinine and serum cystatin C the 95th percentile and for eGFR(CG), eGFR(MDRD) and eGFR(Larsson) the 5th percentile were selected as reference limits. All data was weighted to reflect the age- and sex-structure of the German population in 2008. The reference limits for serum creatinine (men: 1.11-1.23 mg/dL; women: 0.93-1.00 mg/dL) and serum cystatin C levels (men: 0.92-1.04 mg/L; women: 0.84-1.02 mg/L) increased with advancing age. The reference limits for eGFR decreased with increasing age (eGFR(CG) men: 106.0-64.7 mL/min, women 84.4-57.9 mL/min; eGFR(MDRD) men: 82.5-62.2 mL/min/1.73 m², women 75.0-58.2 mL/min/1.73 m²; eGFR(Larsson) men: 85.5-72.9 mL/min, women 94.5-75.7 mL/min). This study presents age- and sex-specific reference limits for five measures of renal function based on quantile regression models.

  7. Evaluation of a xeno-free protocol for long-term cryopreservation of cord blood cells.

    PubMed

    Mairhofer, M; Schulz, J C; Parth, M; Beer, U; Zimmermann, H; Kolbus, A

    2013-01-01

    Cord blood is regarded as a powerful source for adult stem cells. Cord blood transplants have been used successfully to treat children and adults in autologous and allogeneic settings. Nevertheless, in many cases, the clinically relevant cell number (CD34+ cells and total leukocytes) is a limiting factor. To enable standardized cell banking and future in vitro expansion of adult stem/progenitor cells, elimination of serum, which inevitably differs from lot to lot and donor to donor, is highly desirable. Here, we demonstrate the feasibility of a xeno-free, chemically defined cryopreservation procedure for cord blood-derived cells over a period of 1 year. Cell recoveries with respect to retrieval of clinically relevant CD34+ cells, colony-forming units, and in vitro cultures of erythroid progenitor cells under standardized conditions were analyzed after 1 week or 1 year of cryopreservation and found to be very high and similar to the samples before freezing. The established xeno-free procedure is an important step toward using the full potential of adult stem cells from cord blood, enabling the elimination of serum-derived factors negatively influencing proliferation, differentiation, and survival of hematopoietic stem cells.

  8. Reference intervals for selected serum biochemistry analytes in cheetahs Acinonyx jubatus.

    PubMed

    Hudson-Lamb, Gavin C; Schoeman, Johan P; Hooijberg, Emma H; Heinrich, Sonja K; Tordiffe, Adrian S W

    2016-02-26

    Published haematologic and serum biochemistry reference intervals are very scarce for captive cheetahs and even more for free-ranging cheetahs. The current study was performed to establish reference intervals for selected serum biochemistry analytes in cheetahs. Baseline serum biochemistry analytes were analysed from 66 healthy Namibian cheetahs. Samples were collected from 30 captive cheetahs at the AfriCat Foundation and 36 free-ranging cheetahs from central Namibia. The effects of captivity-status, age, sex and haemolysis score on the tested serum analytes were investigated. The biochemistry analytes that were measured were sodium, potassium, magnesium, chloride, urea and creatinine. The 90% confidence interval of the reference limits was obtained using the non-parametric bootstrap method. Reference intervals were preferentially determined by the non-parametric method and were as follows: sodium (128 mmol/L - 166 mmol/L), potassium (3.9 mmol/L - 5.2 mmol/L), magnesium (0.8 mmol/L - 1.2 mmol/L), chloride (97 mmol/L - 130 mmol/L), urea (8.2 mmol/L - 25.1 mmol/L) and creatinine (88 µmol/L - 288 µmol/L). Reference intervals from the current study were compared with International Species Information System values for cheetahs and found to be narrower. Moreover, age, sex and haemolysis score had no significant effect on the serum analytes in this study. Separate reference intervals for captive and free-ranging cheetahs were also determined. Captive cheetahs had higher urea values, most likely due to dietary factors. This study is the first to establish reference intervals for serum biochemistry analytes in cheetahs according to international guidelines. These results can be used for future health and disease assessments in both captive and free-ranging cheetahs.

  9. Serum proteins by capillary zone electrophoresis: approaches to the definition of reference values.

    PubMed

    Petrini, C; Alessio, M G; Scapellato, L; Brambilla, S; Franzini, C

    1999-10-01

    The Paragon CZE 2000 (Beckman Analytical, Milan, Italy) is an automatic dedicated capillary zone electrophoresis (CZE) system, producing a five-zone serum protein pattern with quantitative estimation of the zones. With the view of substituting this instrument for two previously used serum protein electrophoresis techniques, we planned to produce reference values for the "new" systems leading to compatible interpretation of the results. High resolution cellulose acetate electrophoresis with visual inspection and descriptive reporting (HR-CAE) and five-zone cellulose acetate electrophoresis with densitometry (CAE-D) were the previously used techniques. Serum samples (n = 167) giving "normal pattern" with HR-CAE were assayed with the CZE system, and the results were statistically assessed to yield 0.95 reference intervals. One thousand normal and pathological serum samples were then assayed with the CAE-D and the CZE techniques, and the regression equations of the CAE-D values over the CZE values for the five zones were used to transform the CAE-D reference limits into the CZE reference limits. The two sets of reference values thereby produced were in good agreement with each other and also with reference values previously reported for the CZE system. Thus, reference values for the CZE techniques permit interpretation of results coherent with the previously used techniques and reporting modes.

  10. Proposed quality control guidelines for antimicrobial susceptibility tests using tilmicosin.

    PubMed Central

    Shryock, T R; White, D W; Werner, C S; Staples, J M

    1995-01-01

    Quality control guidelines for tilmicosin, a novel veterinary-use-only macrolide, were developed in a multi-laboratory study according to established National Committee for Clinical Laboratory Standards (NCCLS) procedures (M23-T2). Tilmicosin was incorporated into Sensititre plates for broth microdilution endpoint testing and into two lots of 15-micrograms disks for Kirby-Bauer agar disk diffusion testing. One common lot and five unique lots of Mueller-Hinton media were used. (Broth was cation adjusted, and agar was supplemented with 5% defibrinated sheep blood.) Bacteria used for reference strains included Pasteurella haemolytica 128K, Pasteurella multocida ATCC 43137, and Staphylococcus aureus ATCC 29213 (microdilution) and ATCC 25923 (disk). Replicate tests were conducted. Disk diffusion and broth microdilution quality control ranges are proposed. PMID:7714188

  11. Age and sex variation in serum albumin concentration: an observational study.

    PubMed

    Weaving, Gary; Batstone, Gifford F; Jones, Richard G

    2016-01-01

    In the UK, a common reference interval for serum albumin is widely used irrespective of age or sex. Implicit in this is that laboratories produce analytically similar results. This paper challenges the validity of this approach. A three-week collection of results sent to all primary care centres in England has been analysed by age, sex and laboratory. In all, 1,079,193 serum albumin reports were included in this analysis. The mean population serum albumin concentration increases to peak at around age 20 years and then decreases with increasing age. Values in females decrease more rapidly but become close to male values at 60 years. The variation between laboratories was large and potentially clinically significant. Reference intervals for serum albumin should be stratified by age and sex. Until there is greater methodological standardization, laboratories should determine their own reference intervals and not accept a single consensus reference interval. © The Author(s) 2015.

  12. Serum fructosamine concentrations in dogs with hypothyroidism.

    PubMed

    Reusch, C E; Gerber, B; Boretti, F S

    2002-10-01

    Serum fructosamine concentrations were measured in 11 untreated hypothyroid dogs with normal serum glucose and serum protein concentrations. The fructosamine level ranged between 276 and 441 micromol/L (median 376 micromol/L; reference range 207-340 micromol/L). Nine of the 11 dogs had fructosamine levels above the reference range. The fructosamine levels decreased significantly during treatment with levothyroxine. It is suggested that serum fructosamine concentrations may be high in hypothyroid dogs because of decelerated protein turnover, independent of the blood glucose concentration.

  13. Development and Use of a Serum Bactericidal Assay Using Pooled Human Complement To Assess Responses to a Meningococcal Group A Conjugate Vaccine in African Toddlers

    PubMed Central

    Lynn, Freyja; Mocca, Brian; Borrow, Ray; Findlow, Helen; Hassan-King, Musa; Preziosi, Marie-Pierre; Idoko, Olubukola; Sow, Samba; Kulkarni, Prasad; LaForce, F. Marc

    2014-01-01

    A meningococcal group A polysaccharide (PS) conjugate vaccine (PsA-TT) has been developed for African countries affected by epidemic meningitis caused by Neisseria meningitidis. Complement-mediated serum bactericidal antibody (SBA) assays are used to assess protective immune responses to meningococcal vaccination. Human complement (hC′) was used in early studies demonstrating antibody-mediated protection against disease, but it is difficult to obtain and standardize. We developed and evaluated a method for sourcing hC′ and then used the SBA assay with hC′ (hSBA) to measure bactericidal responses to PsA-TT vaccination in 12- to 23-month-old African children. Sera with active complement from 100 unvaccinated blood donors were tested for intrinsic bactericidal activity, SBA titer using rabbit complement (rSBA), and anti-group A PS antibody concentration. Performance criteria and pooling strategies were examined and then verified by comparisons of three independently prepared hC′ lots in two laboratories. hSBA titers of clinical trial sera were then determined using this complement sourcing method. Two different functional antibody tests were necessary for screening hC′. hSBA titers determined using three independent lots of pooled hC′ were within expected assay variation among lots and between laboratories. In African toddlers, PsA-TT elicited higher hSBA titers than meningococcal polysaccharide or Hib vaccines. PsA-TT immunization or PS challenge of PsA-TT-primed subjects resulted in vigorous hSBA memory responses, and titers persisted in boosted groups for over a year. Quantifying SBA using pooled hC′ is feasible and showed that PsA-TT was highly immunogenic in African toddlers. PMID:24671551

  14. Determination of serum calcium levels by 42Ca isotope dilution inductively coupled plasma mass spectrometry.

    PubMed

    Han, Bingqing; Ge, Menglei; Zhao, Haijian; Yan, Ying; Zeng, Jie; Zhang, Tianjiao; Zhou, Weiyan; Zhang, Jiangtao; Wang, Jing; Zhang, Chuanbao

    2017-11-27

    Serum calcium level is an important clinical index that reflects pathophysiological states. However, detection accuracy in laboratory tests is not ideal; as such, a high accuracy method is needed. We developed a reference method for measuring serum calcium levels by isotope dilution inductively coupled plasma mass spectrometry (ID ICP-MS), using 42Ca as the enriched isotope. Serum was digested with 69% ultrapure nitric acid and diluted to a suitable concentration. The 44Ca/42Ca ratio was detected in H2 mode; spike concentration was calibrated by reverse IDMS using standard reference material (SRM) 3109a, and sample concentration was measured by a bracketing procedure. We compared the performance of ID ICP-MS with those of three other reference methods in China using the same serum and aqueous samples. The relative expanded uncertainty of the sample concentration was 0.414% (k=2). The range of repeatability (within-run imprecision), intermediate imprecision (between-run imprecision), and intra-laboratory imprecision were 0.12%-0.19%, 0.07%-0.09%, and 0.16%-0.17%, respectively, for two of the serum samples. SRM909bI, SRM909bII, SRM909c, and GBW09152 were found to be within the certified value interval, with mean relative bias values of 0.29%, -0.02%, 0.10%, and -0.19%, respectively. The range of recovery was 99.87%-100.37%. Results obtained by ID ICP-MS showed a better accuracy than and were highly correlated with those of other reference methods. ID ICP-MS is a simple and accurate candidate reference method for serum calcium measurement and can be used to establish and improve serum calcium reference system in China.

  15. Serum PCB levels and congener profiles among teachers in PCB-containing schools: a pilot study

    PubMed Central

    2011-01-01

    Background PCB contamination in the built environment may result from the release of PCBs from building materials. The significance of this contamination as a pathway of human exposure is not well-characterized, however. This research compared the serum PCB concentrations, and congener profiles between 18 teachers in PCB-containing schools and referent populations. Methods Blood samples from 18 teachers in PCB-containing schools were analyzed for 57 PCB congeners. Serum PCB concentrations and congener patterns were compared between the teachers, to the 2003-4 NHANES (National Health and Nutrition Examination Survey) data, and to data from 358 Greater Boston area men. Results Teachers at one school had higher levels of lighter (PCB 6-74) congeners compared to teachers from other schools. PCB congener 47 contributed substantially to these elevated levels. Older teachers (ages 50-64) from all schools had higher total (sum of 33 congeners) serum PCB concentrations than age-comparable NHANES reference values. Comparing the teachers to the referent population of men from the Greater Boston area (all under age 51), no difference in total serum PCB levels was observed between the referents and teachers up to 50 years age. However, the teachers had significantly elevated serum concentrations of lighter congeners (PCB 6-74). This difference was confirmed by comparing the congener-specific ratios between groups, and principal component analysis showed that the relative contribution of lighter congeners differed between the teachers and the referents. Conclusions These findings suggest that the teachers in the PCB-containing buildings had higher serum levels of lighter PCB congeners (PCB 6-74) than the referent populations. Examination of the patterns, as well as concentrations of individual PCB congeners in serum is essential to investigating the contributions from potential environmental sources of PCB exposure. PMID:21668970

  16. An ABO blood grouping discrepancy: Probable B(A) phenotype.

    PubMed

    Jain, Ashish; Gupta, Anubhav; Malhotra, Sheetal; Marwaha, Neelam; Sharma, Ratti Ram

    2017-06-01

    In B(A) phenotype, an autosomal dominant phenotype, there is a weak A expression on group B RBCs. We herein report a case of a probable B(A) phenotype in a first time 20-year old male donor. The cell and serum grouping were done using tube technique and also with blood grouping gel card (Diaclone, ABD cards for donors, BioRad, Switzerland). The antisera used were commercial monoclonal IgM type. To check for the weak subgroup of A, cold adsorption and heat elution was performed. The cell grouping was A weak B RhD positive while the serum grouping was B. There was no agglutination with O cells and the autologous control was also negative. It was a group II ABO discrepancy with or without group IV discrepancy. Results for both the eluate and last wash were negative. Hence, the possibility of weak subgroup of A was unlikely. Blood grouping gel card also showed a negative reaction in the anti-A column. One lot of anti-A was showing 'weak +' agglutination while the other lot was showing 'negative' reaction with the donor RBCs by tube technique. There was no agglutination observed with anti-A1 lectin. Our case highlights the serological characteristics of a B(A) phenotype. This case emphasizes the vital role of cell and serum grouping in detecting such discrepancies especially in donors which can lead to mislabeling of the blood unit and may be a potential risk for the transfusion recipient if not resolved appropriately. Copyright © 2017 Elsevier Ltd. All rights reserved.

  17. A candidate reference method for serum potassium measurement by inductively coupled plasma mass spectrometry.

    PubMed

    Yan, Ying; Han, Bingqing; Zeng, Jie; Zhou, Weiyan; Zhang, Tianjiao; Zhang, Jiangtao; Chen, Wenxiang; Zhang, Chuanbao

    2017-08-28

    Potassium is an important serum ion that is frequently assayed in clinical laboratories. Quality assurance requires reference methods; thus, the establishment of a candidate reference method for serum potassium measurements is important. An inductively coupled plasma mass spectrometry (ICP-MS) method was developed. Serum samples were gravimetrically spiked with an aluminum internal standard, digested with 69% ultrapure nitric acid, and diluted to the required concentration. The 39K/27Al ratios were measured by ICP-MS in hydrogen mode. The method was calibrated using 5% nitric acid matrix calibrators, and the calibration function was established using the bracketing method. The correlation coefficients between the measured 39K/27Al ratios and the analyte concentration ratios were >0.9999. The coefficients of variation were 0.40%, 0.68%, and 0.22% for the three serum samples, and the analytical recovery was 99.8%. The accuracy of the measurement was also verified by measuring certified reference materials, SRM909b and SRM956b. Comparison with the ion selective electrode routine method and international inter-laboratory comparisons gave satisfied results. The new ICP-MS method is specific, precise, simple, and low-cost, and it may be used as a candidate reference method for standardizing serum potassium measurements.

  18. Analytical Bias Exceeding Desirable Quality Goal in 4 out of 5 Common Immunoassays: Results of a Native Single Serum Sample External Quality Assessment Program for Cobalamin, Folate, Ferritin, Thyroid-Stimulating Hormone, and Free T4 Analyses.

    PubMed

    Kristensen, Gunn B B; Rustad, Pål; Berg, Jens P; Aakre, Kristin M

    2016-09-01

    We undertook this study to evaluate method differences for 5 components analyzed by immunoassays, to explore whether the use of method-dependent reference intervals may compensate for method differences, and to investigate commutability of external quality assessment (EQA) materials. Twenty fresh native single serum samples, a fresh native serum pool, Nordic Federation of Clinical Chemistry Reference Serum X (serum X) (serum pool), and 2 EQA materials were sent to 38 laboratories for measurement of cobalamin, folate, ferritin, free T4, and thyroid-stimulating hormone (TSH) by 5 different measurement procedures [Roche Cobas (n = 15), Roche Modular (n = 4), Abbott Architect (n = 8), Beckman Coulter Unicel (n = 2), and Siemens ADVIA Centaur (n = 9)]. The target value for each component was calculated based on the mean of method means or measured by a reference measurement procedure (free T4). Quality specifications were based on biological variation. Local reference intervals were reported from all laboratories. Method differences that exceeded acceptable bias were found for all components except folate. Free T4 differences from the uncommonly used reference measurement procedure were large. Reference intervals differed between measurement procedures but also within 1 measurement procedure. The serum X material was commutable for all components and measurement procedures, whereas the EQA materials were noncommutable in 13 of 50 occasions (5 components, 5 methods, 2 EQA materials). The bias between the measurement procedures was unacceptably large in 4/5 tested components. Traceability to reference materials as claimed by the manufacturers did not lead to acceptable harmonization. Adjustment of reference intervals in accordance with method differences and use of commutable EQA samples are not implemented commonly. © 2016 American Association for Clinical Chemistry.

  19. Reference Values of 14 Serum Trace Elements for Pregnant Chinese Women: A Cross-Sectional Study in the China Nutrition and Health Survey 2010-2012.

    PubMed

    Liu, Xiaobing; Zhang, Yu; Piao, Jianhua; Mao, Deqian; Li, Yajie; Li, Weidong; Yang, Lichen; Yang, Xiaoguang

    2017-03-21

    The development of reference values of trace elements is recognized as a fundamental prerequisite for the assessment of trace element nutritional status and health risks. In this study, a total of 1400 pregnant women aged 27.0 ± 4.5 years were randomly selected from the China Nutrition and Health Survey 2010-2012 (CNHS 2010-2012). The concentrations of 14 serum trace elements were determined by high-resolution inductively coupled plasma mass spectrometry. Reference values were calculated covering the central 95% reference intervals (P2.5-P97.5) after excluding outliers by Dixon's test. The overall reference values of serum trace elements were 131.5 (55.8-265.0 μg/dL for iron (Fe), 195.5 (107.0-362.4) μg/dL for copper (Cu), 74.0 (51.8-111.3) μg/dL for zinc (Zn), 22.3 (14.0-62.0) μg/dL for rubidium (Rb), 72.2 (39.9-111.6) μg/L for selenium (Se), 45.9 (23.8-104.3) μg/L for strontium (Sr), 1.8 (1.2-3.6) μg/L for molybdenum (Mo), 2.4 (1.2-8.4) μg/L for manganese (Mn), 1.9 (0.6-9.0) ng/L for lead (Pb), 1.1 (0.3-5.6) ng/L for arsenic (As), 835.6 (219.8-4287.7) ng/L for chromium (Cr), 337.9 (57.0-1130.0) ng/L for cobalt (Co), 193.2 (23.6-2323.1) ng/L for vanadium (V), and 133.7 (72.1-595.1) ng/L for cadmium (Cd). Furthermore, some significant differences in serum trace element reference values were observed between different groupings of age intervals, residences, anthropometric status, and duration of pregnancy. We found that serum Fe, Zn, and Se concentrations significantly decreased, whereas serum Cu, Sr, and Co concentrations elevated progressively compared with reference values of 14 serum trace elements in pregnant Chinese women. The reference values of serum trace elements established could play a key role in the following nutritional status and health risk assessment.

  20. Certified reference materials (GBW09170 and 09171) of creatinine in human serum.

    PubMed

    Dai, Xinhua; Fang, Xiang; Shao, Mingwu; Li, Ming; Huang, Zejian; Li, Hongmei; Jiang, You; Song, Dewei; He, Yajuan

    2011-02-15

    Creatinine is the most widely used clinical marker for assessing renal function. Concentrations of creatinine in human serum need to be carefully checked in order to ensure accurate diagnosis of renal function. Therefore, development of certified reference materials (CRMs) of creatinine in serum is of increasing importance. In this study, two new CRMs (Nos. GBW09170 and 09171) for creatinine in human serum have been developed. They were prepared with mixtures of several dozens of healthy people's and kidney disease patient's serum, respectively. The certified values of 8.10, 34.1 mg/kg for these two CRMs have been assigned by liquid chromatography-isotope dilution mass spectrometry (LC-IDMS) method which was validated by using standard reference material (SRM) of SRM909b (a reference material obtained from National Institute of Standards and Technology, NIST). The expanded uncertainties of certified values for low and high concentrations were estimated to be 1.2 and 1.1%, respectively. The certified values were further confirmed by an international intercomparison for the determination of creatinine in human serum (Consultative Committee for Amount of Substance, CCQM) of K80 (CCQM-K80). These new CRMs of creatinine in human serum pool are totally native without additional creatinine spiked for enrichment. These new CRMs are capable of validating routine clinical methods for ensuring accuracy, reliability and comparability of analytical results from different clinical laboratories. They can also be used for instrument validation, development of secondary reference materials, and evaluating the accuracy of high order clinical methods for the determination of creatinine in human serum. Copyright © 2011 Elsevier B.V. All rights reserved.

  1. Hematologic and serum biochemistry reference values in wild-caught white-footed tamarins (Saguinus leucopus) housed in captivity.

    PubMed

    Fox, Maureen; Brieva, Claudia; Moreno, Carlos; MacWilliams, Peter; Thomas, Chet

    2008-12-01

    The white-footed tamarin (Saguinus leucopus) is an endangered primate that lives in a small forest corridor in northern Colombia, South America. Hematologic and serum biochemistry reference values are important tools in evaluating the health of the white-footed tamarin and serve to promote the survival of this species. The purpose of this study was to establish diagnostically important hematologic and serum biochemistry reference values for healthy white-footed tamarins and to determine whether there was significant variation with respect to age class (juveniles, adults), gender, and housing facility. Blood samples were collected for hematologic and serum biochemistry measurements from 29 wild-caught captive tamarins during February and April 2005, housed at three different facilities in central Colombia. Hematology and serum biochemistry values were similar in adults and juveniles. Female white-footed tamarins had absolute reticulocyte counts that were lower than those of male tamarins and males had lower serum chloride concentrations than female tamarins. Mean values for hemoglobin, mean cell hemoglobin, serum total protein, albumin, glucose, and alkaline phosphatase varied among the three housing facilities. Twenty-two of the 29 tamarins sampled were microfilaria-positive and had significantly higher mean serum alkaline phosphatase concentrations. Among the 29 tamarins sampled in this study, serum values for mean alkaline phosphatase and creatine kinase concentrations were higher than reported values for other mammals. The reference intervals determined in this study were comparable to normal ranges reported for other members of the family Callitrichidae.

  2. Systematic review of serum steroid reference intervals developed using mass spectrometry.

    PubMed

    Tavita, Nevada; Greaves, Ronda F

    2017-12-01

    The aim of this study was to perform a systematic review of the published literature to determine the available serum/plasma steroid reference intervals generated by mass spectrometry (MS) methods across all age groups in healthy subjects and to suggest recommendations to achieve common MS based reference intervals for serum steroids. MEDLINE, EMBASE and PubMed databases were used to conduct a comprehensive search for English language, MS-based reference interval studies for serum/plasma steroids. Selection of steroids to include was based on those listed in the Royal College of Pathologists of Australasia Quality Assurance Programs, Chemical Pathology, Endocrine Program. This methodology has been registered onto the PROSPERO International prospective register of systematic reviews (ID number: CRD42015029637). After accounting for duplicates, a total of 60 manuscripts were identified through the search strategy. Following critical evaluation, a total of 16 studies were selected. Of the 16 studies, 12 reported reference intervals for testosterone, 11 for 17 hydroxy-progesterone, nine for androstenedione, six for cortisol, three for progesterone, two for dihydrotestosterone and only one for aldosterone and dehydroepiandrosterone sulphate. No studies established MS-based reference intervals for oestradiol. As far as we are aware, this report provides the first comparison of the peer reviewed literature for serum/plasma steroid reference intervals generated by MS-based methods. The reference intervals based on these published studies can be used to inform the process to develop common reference intervals, and agreed reporting units for mass spectrometry based steroid methods. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  3. Reference intervals for serum osteocalcin concentrations in adult men and women from the study of health in Pomerania.

    PubMed

    Hannemann, Anke; Friedrich, Nele; Spielhagen, Christin; Rettig, Rainer; Ittermann, Till; Nauck, Matthias; Wallaschofski, Henri

    2013-03-13

    Osteocalcin (OC) is a bone-specific protein produced primarily by osteoblasts during bone formation. Besides its role in bone formation, osteocalcin may play a role in the regulation of energy metabolism and male fertility. To interpret serum OC data, reference intervals adapted to a specific laboratory method are needed. A healthy reference population was selected from the first follow-up of the Study of Health in Pomerania. Serum OC concentrations were measured with the IDS-iSYS N-Mid Osteocalcin assay on the IDS-iSYS Automated System (Immunodiagnostic Systems, Frankfurt am Main, Germany). The reference interval was defined as the central 95% range (2.5th-97.5th percentile). Age-specific reference intervals were calculated by quantile regression for 1107 men (25-79 years) and 545 premenopausal women (25-54 years). The reference interval for 498 postmenopausal women (50-79 years) was calculated irrespective of age. Median (1st-3rd quartile) serum OC concentrations were 15.4 ng/mL (12.0-19.4 ng/mL) in men, 14.4 ng/mL (11.3-18.5 ng/mL) in premenopausal women, and 18.6 ng/mL (13.6-25.6 ng/mL) in postmenopausal women. Serum OC concentrations were highest in men and premenopausal women aged 25-29 years, were stable during midlife, and rose again after 65 years of age in men and at transition to menopause in women. Serum OC concentrations were lower in women taking oral contraceptives or who were under hormone replacement therapy after menopause and in subjects with diabetes mellitus or with body mass index < 18 or > 30 kg/m2 than in subjects without these conditions. We established sex-specific adult reference intervals for the serum OC concentration measured by the IDS-iSYS N-Mid Osteocalcin assay.

  4. Reference intervals for acute phase protein and serum protein electrophoresis values in captive Asian elephants (Elephas maximus).

    PubMed

    Isaza, Ramiro; Wiedner, Ellen; Hiser, Sarah; Cray, Carolyn

    2014-09-01

    Acute phase protein (APP) immunoassays and serum protein electrophoresis (SPEP) are assays for evaluating the inflammatory response and have use as diagnostic tools in a variety of species. Acute phase proteins are markers of inflammation that are highly conserved across different species while SPEP separates and quantifies serum protein fractions based on their physical properties. In the current study, serum samples from 35 clinically healthy Asian elephants (Elephas maximus) were analyzed using automated assays for C-reactive protein, serum amyloid A, and haptoglobin and SPEP. Robust methods were used to generate reference intervals for the APPs: C-reactive protein (1.3-12.8 mg/l), serum amyloid A (0-47.5 mg/l), and haptoglobin (0-1.10 mg/ml). In addition, SPEP was performed on these samples to establish reference intervals for each protein fraction. A combination of APPs and SPEP measurements are valuable adjunctive diagnostic tools in elephant health care. © 2014 The Author(s).

  5. Safety and immunogenicity of a trivalent, inactivated, mammalian cell culture-derived influenza vaccine in healthy adults, seniors, and children.

    PubMed

    Halperin, Scott A; Smith, Bruce; Mabrouk, Taoufik; Germain, Marc; Trépanier, Pierre; Hassell, Thomas; Treanor, John; Gauthier, Richard; Mills, Elaine L

    2002-01-15

    We performed randomized, double-blind, controlled trials to assess the safety and immunogenicity of an inactivated, Madin Darby Canine Kidney (MDCK)-derived cell line produced influenza vaccine in healthy adults (19-50 years), children (3-12 years) and the elderly (> or =65 years). We studied three lots of cell culture-derived vaccine and one lot of licensed egg-derived vaccine in healthy adults (n=462), two lots of cell culture-derived vaccine and one lot of egg-derived vaccine in seniors (n=269), and one lot of each vaccine in children (n=209). Adverse events were collected during the first 3 days post-immunization; serum was collected before and 1 month after immunization. Rates of local and systemic adverse reactions were similar with both vaccines. An injection site adverse event rated at least moderate severity was reported by 21.9% of children who received the egg-derived vaccine and 25.0% of those who received the cell culture-derived vaccine. In healthy adults the proportions were 12.1 and 15.3%, respectively and 6.7 and 6.3%, respectively in seniors. Systemic events of at least moderate severity were 12.4 and 12.5% in children, 19.8 and 13.6% in healthy adults, and 14.1 and 9.7% in seniors; none of these differences were statistically significant. The antibody response against all three viruses was similar between the two vaccines. From 83 to 100% of children, healthy adults and seniors achieved hemagglutination inhibition titers in excess of 40 post-immunization. We conclude that the cell culture-derived vaccine was safe and immunogenic in children, healthy adults and seniors.

  6. Serum levels of lipoprotein(a) and homocysteine in patients on hemodialysis who take hydroxymethylglutaryl-CoA reductase inhibitors, vitamin B6, and folic acid.

    PubMed

    Shojaei, Mir Hatef; Djalali, Mamhmoud; Siassi, Fereydoun; Khatami, Mohammad Reza; Boroumand, Mohammad Ali; Eshragian, Mohammad Reza

    2009-07-01

    High serum levels of lipoprotein(a) and homocysteine are risk factors of cardiovascular disease which are prevalent in patients on hemodialysis. Controversy exists about the effects of hydroxymethylglutaryl-CoA reductase inhibitors on serum lipoprotein(a) levels in patients on hemodialysis. Also, deficiency of some water soluble vitamins and administration of statins may raise serum levels of homocysteine in these patients. This study was designed to investigate serum levels of lipoprotein(a) and homocysteine in patients on hemodialysis who were taking a statin, vitamin B6, and folic acid. We investigated on 152 patients with maintenance hemodialysis who were taking atorvastatin or lovastatin, vitamin B6, and folic acid for at least 6 months. Their serum levels were obtained to measure lipoprotein(a) and homocysteine levels, as well as triglyceride, total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol. The mean serum values of total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol and triglyceride were significantly less than the maximum reference values (P < .001). The mean serum level of lipoprotein(a) was also less than the reference value (P = .009), but homocysteine level was 33% higher on average than the reference value (P < .001). Our study demonstrated that in our patients on hemodialysis, the mean serum level of homocysteine was about 30% higher than the reference value although they were receiving vitamin B6 and folic acid. Hence, they were still exposed to the risk of cardiovascular disease.

  7. The elevated serum urea:creatinine ratio in canine babesiosis in South Africa is not of renal origin.

    PubMed

    de Scally, M P; Leisewitz, A L; Lobetti, R G; Thompson, P N

    2006-12-01

    Pigmented serum, usually due to free haemoglobin and/or bilirubin, is a common finding in dogs with babesiosis, resulting in interference with all biochemical tests that rely on photochemistry. This is particularly true of urea and creatinine determinations, complicating the diagnosis of acute renal failure, which is a serious complication of babesiosis. A disproportionately raised serum urea concentration of unknown origin occurs in severely anaemic canine babesiosis patients and gives rise to an increased serum urea:creatinine ratio. The assay for cystatin-C, an excellent measure of glomerular filtration rate, is unaffected by free serum haemoglobin, and due to its different intrinsic origins, is free of influence by the metabolic derangements and organ pathology, other than renal disease, encountered in canine babesiosis. Serum cystatin-C was used to compare the concentrations of serum urea and serum creatinine in dogs with the severely anaemic form of canine babesiosis as well as a canine babesiosis-free reference group. Mean serum urea and mean serum urea:creatinine ratio were significantly elevated in the babesia-infected group relative to the reference population in this study. Mean serum creatinine and mean serum cystatin-C were within the reference ranges. Therefore an elevated urea:creatinine ratio in canine babesiosis in the presence of a normal serum creatinine concentration is considered to be caused by an elevated serum urea concentration and is most likely of non-renal origin. Serum creatinine was therefore as specific a measure of renal function as serum cystatin-C in canine babesiosis in this study. The sensitivity of serum creatinine as a measure of renal function was not established by this study. Serum urea, however, proved to be of little use compared to serum cystatin-C and serum creatinine. Serum urea should therefore not be used to diagnose renal failure in canine babesiosis.

  8. Development of certified reference materials for electrolytes in human serum (GBW09124-09126).

    PubMed

    Feng, Liuxing; Wang, Jun; Cui, Yanjie; Shi, Naijie; Li, Haifeng; Li, Hongmei

    2017-05-01

    Three reference materials, at relatively low, middle, and high concentrations, were developed for analysis of the mass fractions of electrolytes (K, Ca, Na, Mg, Cl, and Li) in human serum. The reference materials were prepared by adding high purity chloride salts to normal human serum. The concentration range of the three levels is within ±20% of normal human serum. It was shown that 14 units with duplicate analysis is enough to demonstrate the homogeneity of these candidate reference materials. The statistical results also showed no significant trends in both short-term stability test for 1 week at 40 °C and long-term stability test for 14 months. The certification methods of the six elements include isotope dilution inductively coupled plasma mass spectrometry (ID-ICP-MS), inductively coupled plasma optical emission spectroscopy (ICP-OES), atomic absorption spectroscopy (AAS), ion chromatography (IC), and ion-selective electrode (ISE). The certification methods were validated by international comparisons among a number of national metrology institutes (NMIs). The combined relative standard uncertainties of the property values were estimated by considering the uncertainties of the analytical methods, homogeneity, and stability. The range of the expanded uncertainties of all the elements is from 2.2% to 3.9%. The certified reference materials (CRMs) are primarily intended for use in the calibration and validation of procedures in clinical analysis for the determination of electrolytes in human serum or plasma. Graphical Abstract Certified reference materials for K, Ca, Mg, Na, Cl and Li in human serum (GBW09124-09126).

  9. Serological reactions in Rhesus monkeys inoculated with the 17D strain of yellow fever virus.

    PubMed

    GROOT, H

    1962-01-01

    Haemagglutination-inhibition tests, which depend on the appearance of haemagglutination-inhibiting antibodies in the serum in virus infections, are in common use in the study of arthropod-borne diseases. This paper contains the results of an investigation into the appearance and pattern of haemagglutination-inhibiting antibodies in the serum of rhesus monkeys inoculated intracerebrally with the 17D strain of yellow fever virus during the testing of seed lots of yellow fever vaccine. These antibodies appeared on the tenth day after inoculation, and were still demonstrable four years later. In all of the eight monkeys tested complement-fixing and neutralizing antibodies against yellow fever antigens also developed, and in six out of the eight heterologous antigens developed.

  10. Identification of Mouse Serum miRNA Endogenous References by Global Gene Expression Profiles

    PubMed Central

    Mi, Qing-Sheng; Weiland, Matthew; Qi, Rui-Qun; Gao, Xing-Hua; Poisson, Laila M.; Zhou, Li

    2012-01-01

    MicroRNAs (miRNAs) are recently discovered small non-coding RNAs and can serve as serum biomarkers for disease diagnosis and prognoses. Lack of reliable serum miRNA endogenous references for normalization in miRNA gene expression makes single miRNA assays inaccurate. Using TaqMan® real-time PCR miRNA arrays with a global gene expression normalization strategy, we have analyzed serum miRNA expression profiles of 20 female mice of NOD/ShiLtJ (n = 8), NOR/LtJ (n = 6), and C57BL/6J (n = 6) at different ages and disease conditions. We identified five miRNAs, miR-146a, miR-16, miR-195, miR-30e and miR-744, to be stably expressed in all strains, which could serve as mouse serum miRNA endogenous references for single assay experiments. PMID:22348064

  11. Reference Values of 14 Serum Trace Elements for Pregnant Chinese Women: A Cross-Sectional Study in the China Nutrition and Health Survey 2010–2012

    PubMed Central

    Liu, Xiaobing; Zhang, Yu; Piao, Jianhua; Mao, Deqian; Li, Yajie; Li, Weidong; Yang, Lichen; Yang, Xiaoguang

    2017-01-01

    The development of reference values of trace elements is recognized as a fundamental prerequisite for the assessment of trace element nutritional status and health risks. In this study, a total of 1400 pregnant women aged 27.0 ± 4.5 years were randomly selected from the China Nutrition and Health Survey 2010–2012 (CNHS 2010–2012). The concentrations of 14 serum trace elements were determined by high-resolution inductively coupled plasma mass spectrometry. Reference values were calculated covering the central 95% reference intervals (P2.5–P97.5) after excluding outliers by Dixon’s test. The overall reference values of serum trace elements were 131.5 (55.8-265.0 μg/dL for iron (Fe), 195.5 (107.0–362.4) μg/dL for copper (Cu), 74.0 (51.8–111.3) μg/dL for zinc (Zn), 22.3 (14.0–62.0) μg/dL for rubidium (Rb), 72.2 (39.9–111.6) μg/L for selenium (Se), 45.9 (23.8-104.3) μg/L for strontium (Sr), 1.8 (1.2–3.6) μg/L for molybdenum (Mo), 2.4 (1.2–8.4) μg/L for manganese (Mn), 1.9 (0.6–9.0) ng/L for lead (Pb), 1.1 (0.3-5.6) ng/L for arsenic (As), 835.6 (219.8–4287.7) ng/L for chromium (Cr), 337.9 (57.0–1130.0) ng/L for cobalt (Co), 193.2 (23.6–2323.1) ng/L for vanadium (V), and 133.7 (72.1–595.1) ng/L for cadmium (Cd). Furthermore, some significant differences in serum trace element reference values were observed between different groupings of age intervals, residences, anthropometric status, and duration of pregnancy. We found that serum Fe, Zn, and Se concentrations significantly decreased, whereas serum Cu, Sr, and Co concentrations elevated progressively compared with reference values of 14 serum trace elements in pregnant Chinese women. The reference values of serum trace elements established could play a key role in the following nutritional status and health risk assessment. PMID:28335545

  12. Multicenter evaluation of the Bayer Immuno I CA 15-3 assay.

    PubMed

    Cheli, C D; Morris, D L; Kish, L; Goldblatt, J; Neaman, I; Allard, W J; Yeung, K K; Wu, A H; Moore, R; Chan, D W; Fritsche, H A; Schwartz, M K; Very, D L

    1998-04-01

    We conducted a multicenter evaluation of the analytical and clinical features of the automated Bayer Immuno 1 CA 15-3 assay and compared assay performance to two manual tests. Results of the 10-day imprecision study of the Bayer Immuno 1 assay pooled across four evaluation sites and three lots of reagent produced total CV < or = 4%. Lot-to-lot reproducibility for 26 different lots of reagents and calibrators manufactured over a 2-year period was demonstrated (CV, 1.1%). Results for the Bayer Immuno 1 assay correlated well with the Biomira TRUQUANT BR 27.29 and Centocor CA 15-3 RIAs (r > or = 0.94). The upper limit of the reference interval for the Bayer Immuno 1 assay was 35.9 kilounits/L (35.9 units/mL); values were similar for all methods. Longitudinal monitoring of healthy women yielded assay values with an average CV of 11% and 21% for the Bayer Immuno 1 and Biomira assays, respectively. The Bayer Immuno 1 assay demonstrated the analytical features, intermethod correlation, and long-term performance characteristics that are essential for longitudinal monitoring of breast cancer patients.

  13. Hematology and serum chemistry reference ranges of free-ranging moose (Alces alces) in Norway.

    PubMed

    Rostal, Melinda K; Evans, Alina L; Solberg, Erling J; Arnemo, Jon M

    2012-07-01

    Baseline reference ranges of serum chemistry and hematology data can be important indicators for the status of both individuals or populations of wild animals that are affected by emerging pathogens, toxicants, or other causes of disease. Frequently, reference ranges for these values are not available for wildlife species or subspecies. We present hematologic and serum chemistry reference ranges for moose (Alces alces) adults, yearlings, and calves in Norway sampled from 1992-2000. Additionally, we demonstrated that both induction time and chase time were correlated with initial rectal temperature, although they were not significantly correlated with cortisol, aspartate aminotransferase, glucose, or creatine kinase. Overall, the reference ranges given here are similar to those given for American moose, with a few differences that can be attributed to environment, testing methodology, or subspecies or species status. This is the first report, to our knowledge, of reference ranges for moose in Norway.

  14. Fertility in women of late reproductive age: the role of serum anti-Müllerian hormone (AMH) levels in its assessment.

    PubMed

    Meczekalski, B; Czyzyk, A; Kunicki, M; Podfigurna-Stopa, A; Plociennik, L; Jakiel, G; Maciejewska-Jeske, M; Lukaszuk, K

    2016-11-01

    Fertility is referred to the capability for having offspring and can be evaluated by fertility rate. Women's fertility is strictly dependent on individual's age. The fertility peak occurs in the early 20s, and it starts to decline in the third and fourth decades of life (falling sharply after age 35). The aim of this work is to review the available data concerning fertility in women of late reproductive age, especially the role of serum anti-Müllerian hormone (AMH) levels. There are a lot of factors responsible for decrease of fertility in women of late reproductive age. These factors can be classified as oocyte-dependent (decrease in oocyte quantity and quality) and oocyte-independent (reproductive organs [uterus, oviducts] status and general health). Anti-Müllerian hormone (AMH) is a dimeric glycoprotein of the transforming growth factor-β (TGF-β) superfamily produced directly by the ovarian granulosa cells of secondary, preantral, and early antral follicles. It has been used as an ovarian reserve marker since 2002. Anti-Müllerian hormone seems to be the best endocrine marker for assessing the age-related decline of the ovarian pool in healthy women. Evaluation of AMH's predictive value in the naturally aging population is important for counseling women about reproductive planning as well as for treatment planning for women experiencing hormone-sensitive gynecological conditions such as endometriosis and fibroids. AMH can be considered as an indicator of fertility in late reproductive age women and pregnancy outcome in assisted reproductive technology cycles. AMH can strongly predict poor response in the controlled ovarian stimulation.

  15. Frequency of Unnecessarily Biopsies among Patients with Suspicion of Prostate Cancer in Syrian Men.

    PubMed

    Bachour, Dala-Maria; Chahin, Emil; Al-Fahoum, Sahar

    2015-01-01

    The prevalence of prostate cancer is considered high in many countries, and screening tests are very important in order to detect prostate cancer in its early stages; however false positivity with these screening tests means that a lot of patients undergo unnecessary biopsy, which is an invasive procedure, for the confirmatory test. The purpose of this study was to estimate the frequency of unnecessary biopsy cases in patients referred for prostate biopsy in one of the most important and overload cancer centers in Syria. Retrospective data for a period of four years between January 2009 and December 2012 were collected in Al- Bayrouni University Medical hospital in Damascus, Syria. The patients from whom data were collected were referred to our histopathological department because of elevated prostate specific antigen (PSA) serum or an abnormal digital rectal examination (DRE). All patients underwent prostatic TRUS-guided biopsies. Diagnosis of prostate cancer (PCa) or benign prostatic hyperplasia (BPH) was based on histopathological examination and prostate cancers cases were graded and scored according to the Gleason score system. For the 406 patients referred to biopsy, the mean±SD age was 58.4 ±23.3 years. The mean ± SD PSA level was 49.2±21.5 ng/ ml. Of the total we found 237 patients diagnosed with PCa (58. 4%), 166 patients with BPH (40.9%) and 3 cases were unable to be diagnosed (0.7%) because of biopsy collection errors. Our study shows that a high percentage of patients are undergoing unnecessary biopsy, which suggests that the performed screening tests had a high level of false positive and may need re-evaluation.

  16. Porcine platelet lysate as a supplement for animal cell culture

    PubMed Central

    Aldén, Anna; Gonzalez, Lorena; Persson, Anna; Christensson, Kerstin; Holmqvist, Olov

    2007-01-01

    A novel supplementation of cell growth media based on a porcine platelet lysate was developed for culture of animal-derived cells. The platelet lysate was produced from porcine blood and contained lysate of platelets and plasma components. It showed satisfactory microbiological integrity and it carried only low amount of endotoxins (<10 EU/mL). The porcine platelet lysate supported well proliferation of Vero (African green monkey transformed kidney epithelial cells), Chinese hamster ovary (CHO) and hybridoma cells comparable to fetal bovine serum (FBS). Platelet lysate shows promise as a viable choice over FBS as it can be produced in large quantities, high lot-to-lot consistency and with an attractive price structure. Furthermore it is a strong alternative to FBS for ethical reasons. It is expected that it can be used as a general supplementation for most animal cells for research studies on the proliferation of cells and their expression of products. PMID:19002989

  17. Accuracy in Dental Medicine, A New Way to Measure Trueness and Precision

    PubMed Central

    Ender, Andreas; Mehl, Albert

    2014-01-01

    Reference scanners are used in dental medicine to verify a lot of procedures. The main interest is to verify impression methods as they serve as a base for dental restorations. The current limitation of many reference scanners is the lack of accuracy scanning large objects like full dental arches, or the limited possibility to assess detailed tooth surfaces. A new reference scanner, based on focus variation scanning technique, was evaluated with regards to highest local and general accuracy. A specific scanning protocol was tested to scan original tooth surface from dental impressions. Also, different model materials were verified. The results showed a high scanning accuracy of the reference scanner with a mean deviation of 5.3 ± 1.1 µm for trueness and 1.6 ± 0.6 µm for precision in case of full arch scans. Current dental impression methods showed much higher deviations (trueness: 20.4 ± 2.2 µm, precision: 12.5 ± 2.5 µm) than the internal scanning accuracy of the reference scanner. Smaller objects like single tooth surface can be scanned with an even higher accuracy, enabling the system to assess erosive and abrasive tooth surface loss. The reference scanner can be used to measure differences for a lot of dental research fields. The different magnification levels combined with a high local and general accuracy can be used to assess changes of single teeth or restorations up to full arch changes. PMID:24836007

  18. 2013 ETA Guideline: Management of Subclinical Hypothyroidism

    PubMed Central

    Pearce, Simon H.S.; Brabant, Georg; Duntas, Leonidas H.; Monzani, Fabio; Peeters, Robin P.; Razvi, Salman; Wemeau, Jean-Louis

    2013-01-01

    Subclinical hypothyroidism (SCH) should be considered in two categories according to the elevation in serum thyroid-stimulating hormone (TSH) level: mildly increased TSH levels (4.0-10.0 mU/l) and more severely increased TSH value (>10 mU/l). An initially raised serum TSH, with FT4 within reference range, should be investigated with a repeat measurement of both serum TSH and FT4, along with thyroid peroxidase antibodies, preferably after a 2- to 3-month interval. Even in the absence of symptoms, replacement therapy with L-thyroxine is recommended for younger patients (<65-70 years) with serum TSH >10 mU/l. In younger SCH patients (serum TSH <10 mU/l) with symptoms suggestive of hypothyroidism, a trial of L-thyroxine replacement therapy should be considered. For such patients who have been started on L-thyroxine for symptoms attributed to SCH, response to treatment should be reviewed 3 or 4 months after a serum TSH within reference range is reached. If there is no improvement in symptoms, L-thyroxine therapy should generally be stopped. Age-specific local reference ranges for serum TSH should be considered in order to establish a diagnosis of SCH in older people. The oldest old subjects (>80-85 years) with elevated serum TSH ≤10 mU/l should be carefully followed with a wait-and-see strategy, generally avoiding hormonal treatment. If the decision is to treat SCH, then oral L-thyroxine, administered daily, is the treatment of choice. The serum TSH should be re-checked 2 months after starting L-thyroxine therapy, and dosage adjustments made accordingly. The aim for most adults should be to reach a stable serum TSH in the lower half of the reference range (0.4-2.5 mU/l). Once patients with SCH are commenced on L-thyroxine treatment, then serum TSH should be monitored at least annually thereafter. PMID:24783053

  19. Preparation of canine C-reactive protein serum reference material: A feasibility study.

    PubMed

    Canalias, Francesca; Piñeiro, Matilde; Pato, Raquel; Peña, Raquel; Bosch, Lluís; Soler, Lourdes; García, Natalia; Lampreave, Fermín; Saco, Yolanda; Bassols, Anna

    2018-03-01

    The availability of a species-specific reference material is essential for the harmonization of results obtained in different laboratories by different methods. We describe the preparation of a canine C-reactive protein (cCRP) serum reference material containing purified cCRP stabilized in a serum matrix. The material can be used by manufacturers to assign values to their calibrator and control materials. The serum matrix was obtained using blood collected from healthy dogs, stabilized and submitted for a delipidation process. The reference material was prepared by diluting purified cCRP in the serum matrix containing 1.0 mol/L HEPES buffer, 3.0 mmol/L calcium chloride, 80,000 kUI/L aprotinin, and 1.0 mmol/L benzamidine hydrochloride monohydrate at a pH of 7.2, and dispensing (0.5 mL) the matrix into vials that were then frozen. The pilot batch of 200 vials was shown to be homogeneous and stable after a stability study at various temperatures and over a total time of 110 days. The prepared material was submitted to an assignment value study. Eight laboratories from different European countries participated by using the same reagents for an immunoturbidimetric method adapted for different analyzers. The obtained cCRP concentration in the reference material was 78.5 mg/L with an expanded uncertainty (k = 2) of 4.2 mg/L. Canine C-reactive protein serum reference material has been produced that allows harmonization of results obtained by different methods and different laboratories, thus reducing the possibility of errors and misunderstandings. © 2018 American Society for Veterinary Clinical Pathology.

  20. Analyses of laboratory data and establishment of reference values and intervals for healthy elderly people.

    PubMed

    Kubota, K; Kadomura, T; Ohta, K; Koyama, K; Okuda, H; Kobayashi, M; Ishii, C; Fujiwara, Y; Nishiora, T; Ohmae, Y; Ohmae, T; Kitajima, M

    2012-04-01

    Protein-energy malnutrition is a common disorder in the elderly. Although serum albumin is commonly used as a nutritional marker, data is lacking on serum albumin levels in the elderly. The purpose of this study was to determine whether serum albumin levels decrease with advancing age and to establish reference value and interval of laboratory data for elderly people (75 years and over). Blood samples from 13821 healthy people, 42064 outpatients, and 15959 inpatients were collected during 2008. Blood from 127 of our nutrition support team (NST) patients was also collected during August 2006 and May 2009, and analyzed. Serum albumin, hemoglobin, total cholesterol levels and lymphocyte count were determined. We analyzed the change in each parameter in accordance with age, compared the data for elderly people with younger people, and established new reference values. Clinical outcomes were examined depending on the improved reference values. Albumin was lower in older persons than in younger persons. The estimated reference value and interval were 42 (48-36) g/l in older persons and was much lower in NST patients. Hemoglobin was decreased while cholesterol and lymphocyte count were not changed in older persons: all were markedly decreased in NST patients. Terms of hospital stay were significantly longer and mortality rates were significantly higher in older persons, comparing from above to below using a new reference value of albumin (36 g/l). The serum albumin level decreases with advancing age, but it was maintained to some extent in healthy older people. Serum albumin levels related to the clinical outcome. Hemoglobin and cholesterol levels and lymphocyte count were all lower in NST patients. These measurements may be valuable markers of nutritional status and can help in guiding the need for nutritional support.

  1. 21 CFR 211.194 - Laboratory records.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... specific component, drug product container, closure, in-process material, or drug product, and lot tested... product container, closure, in-process material, or drug product tested. (7) The initials or signature of... of any testing and standardization of laboratory reference standards, reagents, and standard...

  2. Development of a NIST standard reference material containing thirty volatile organic compounds at 5 nmol/mol in nitrogen.

    PubMed

    Rhoderick, George C; Yen, James H

    2006-05-01

    Primary gravimetric gas cylinder standards containing 30 volatile organic compounds (VOCs) in nitrogen were prepared using a procedure previously developed to prepare gas mixture cylinder standards of VOCs at the 5 nmol/mol level. This set of primary standards was intercompared to existing gas cylinder standards, containing as many as 19 of the 30 volatile organics present in these new primaries, using gas chromatography with a hydrogen flame ionization detector coupled with cryogenic preconcentration. The linear regression analysis showed excellent agreement among the standards for each compound. Similar mixtures containing many of these compounds in treated aluminum gas cylinders have been evaluated over time and have shown stability for as much as 10 years. The development of these 30-component primary standards led to the preparation and certification of a reissue of Standard Reference Material (SRM) 1804 at the nominal amount-of-substance fraction of 5 nmol/mol for each analyte. A lot of 20 cylinders containing the mixture was prepared at NIST following previously demonstrated protocols for preparation of the cylinders. Each cylinder was analyzed against one cylinder from the lot, designated as the "lot standard," for each of the 30 compounds. As a result of the uncertainty analysis, the data showed that rather than declaring the lot homogeneous with a much higher uncertainty, each cylinder could be individually certified. The expanded uncertainty limits ranged from 1.5 to 10% for 28 of the 30 analytes, with two of the analytes having uncertainties as high as 19% in those SRM cylinders certified. Due to stability issues and some high uncertainties for a few analytes in 2 of the samples, 18 of the 20 candidate SRM samples were certified. These volatile organic gas mixtures represent the most complex gas SRMs developed at NIST.

  3. Hemoglobin A1c Point-of-Care Assays; a New World with a Lot of Consequences!

    PubMed Central

    Lenters-Westra, Erna; Slingerland, Robbert J.

    2009-01-01

    Background Point-of-care instruments for the measurement of hemoglobin A1c (HbA1c) may improve the glycemic control of people with diabetes by providing a rapid result if the performance of the instruments used is acceptable. A 0.5% HbA1c difference between successive results is considered a clinically relevant change. With this in mind, the In2it from Bio-Rad and the DCA Vantage from Siemens were evaluated according to Clinical and Laboratory Standards Institute (CLSI) protocols. Methods The CLSI protocols EP-5 and EP-9 were applied to investigate precision, accuracy, and bias. The bias was compared with three certified secondary reference measurement procedures. Differences between capillary and venous blood were investigated by an end-user group consisting of nurse practitioners at a diabetes care center. Results At HbA1c levels of 5.1 and 11.2%, total coefficients of variation (CV) for the In2it were 4.9 and 3.3%, respectively, and for the DCA Vantage were 1.7 to 1.8% and 3.7 to 5.5% depending on the lot number of the cartridges. Method comparisons showed significant lot number-dependent results for the In2it and the DCA Vantage compared with the three reference methods. No overall difference was observed between capillary and venous blood for both methods. Conclusion Performance results of the In2it and the DCA Vantage showed variable and lot number-dependent results. To maintain the interlaboratory CV of 5% for HbA1c, the Clinical Laboratory Improvement Amendments rules for waived point-of-care instruments should be revised. An obligation for participating in external quality schemes and taking adequate action should be considered for POC instruments that perform poorly. PMID:20144277

  4. Serum bicarbonate and mortality in adults in NHANES III.

    PubMed

    Raphael, Kalani L; Zhang, Yingying; Wei, Guo; Greene, Tom; Cheung, Alfred K; Beddhu, Srinivasan

    2013-05-01

    Low serum bicarbonate concentration is a risk factor for death in people with chronic kidney disease (CKD). Whether low serum bicarbonate is a mortality risk factor for people without CKD is unknown. National Health and Nutrition Examination Survey III (NHANES III) adult participants were categorized into one of four serum bicarbonate categories: <22, 22-25, 26-30 and ≥ 31 mM. Cox models were used to determine the hazards of death in each serum bicarbonate category, using 26-30 mM as the reference group, in the (i) entire population, (ii) non-CKD subgroup and (iii) CKD subgroup. After adjusting for age, gender, race, estimated glomerular filtration rate, albuminuria, diuretic use, smoking, C-reactive protein, cardiovascular disease, protein intake, diabetes, hypertension, body mass index, lung disease and serum albumin, the hazards of death in the <22 mM serum bicarbonate category were 1.75 (95% CI: 1.12-2.74), 1.56 (95% CI: 0.78-3.09) and 2.56 (95% CI: 1.49-4.38) in the entire population, non-CKD subgroup and CKD subgroup, respectively, compared with the reference group. Hazard ratios in the other serum bicarbonate categories in the entire population and non-CKD and CKD subgroups did not differ from the reference group. Among the NHANES III participants, low serum bicarbonate was not observed to be a strong predictor of mortality in people without CKD. However, low serum bicarbonate was associated with a 2.6-fold increased hazard of death in people with CKD.

  5. Pathogen-free, plasma-poor platelet lysate and expansion of human mesenchymal stem cells.

    PubMed

    Iudicone, Paola; Fioravanti, Daniela; Bonanno, Giuseppina; Miceli, Michelina; Lavorino, Claudio; Totta, Pierangela; Frati, Luigi; Nuti, Marianna; Pierelli, Luca

    2014-01-27

    Supplements to support clinical-grade cultures of mesenchymal stem cells (MSC) are required to promote growth and expansion of these cells. Platelet lysate (PL) is a human blood component which may replace animal serum in MSC cultures being rich in various growth factors. Here, we describe a plasma poor pathogen-free platelet lysate obtained by pooling 12 platelet (PLT) units, to produce a standardized and safe supplement for clinical-grade expansion of MSC. PL lots were obtained by combining 2 6-unit PLT pools in additive solution (AS) following a transfusional-based procedure including pathogen inactivation (PI) by Intercept technology and 3 cycles of freezing/thawing, followed by membrane removal. Three PI-PL and 3 control PL lots were produced to compare their ability to sustain bone marrow derived MSC selection and expansion. Moreover, two further PL, subjected to PI or not, were also produced starting from the same initial PLT pools to evaluate the impact of PI on growth factor concentration and capacity to sustain cell growth. Additional PI-PL lots were used for comparison with fetal bovine serum (FBS) on MSC expansion. Immunoregulatory properties of PI-PL-generated MSC were documented in vitro by mixed lymphocyte culture (MLC) and peripheral blood mononuclear cells (PBMC) mitogen induced proliferation. PI-PL and PL control lots had similar concentrations of 4 well-described growth factors endowed with MSC stimulating ability. Initial growth and MSC expansion by PI-PL and PL controls were comparable either using different MSC populations or in head to head experiments. Moreover, PI-PL and PL control sustained similar MSC growth of frozen/thawed MSC. Multilineage differentiation of PI-derived and PI-PL-derived MSC were maintained in any MSC cultures as well as their immunoregulatory properties. Finally, no direct impact of PI on growth factor concentration and MSC growth support was observed, whereas the capacity of FBS to sustain MSC expansion in basic medium was irrelevant as compared to PL and PI-PL. The replacement of animal additives with human supplements is a basic issue in MSC ex vivo production. PI-PL represents a standardized, plasma-poor, human preparation which appears as a safe and good candidate to stimulate MSC growth in clinical-scale cultures.

  6. Pathogen-free, plasma-poor platelet lysate and expansion of human mesenchymal stem cells

    PubMed Central

    2014-01-01

    Background Supplements to support clinical-grade cultures of mesenchymal stem cells (MSC) are required to promote growth and expansion of these cells. Platelet lysate (PL) is a human blood component which may replace animal serum in MSC cultures being rich in various growth factors. Here, we describe a plasma poor pathogen-free platelet lysate obtained by pooling 12 platelet (PLT) units, to produce a standardized and safe supplement for clinical-grade expansion of MSC. Methods PL lots were obtained by combining 2 6-unit PLT pools in additive solution (AS) following a transfusional-based procedure including pathogen inactivation (PI) by Intercept technology and 3 cycles of freezing/thawing, followed by membrane removal. Three PI-PL and 3 control PL lots were produced to compare their ability to sustain bone marrow derived MSC selection and expansion. Moreover, two further PL, subjected to PI or not, were also produced starting from the same initial PLT pools to evaluate the impact of PI on growth factor concentration and capacity to sustain cell growth. Additional PI-PL lots were used for comparison with fetal bovine serum (FBS) on MSC expansion. Immunoregulatory properties of PI-PL-generated MSC were documented in vitro by mixed lymphocyte culture (MLC) and peripheral blood mononuclear cells (PBMC) mitogen induced proliferation. Results PI-PL and PL control lots had similar concentrations of 4 well-described growth factors endowed with MSC stimulating ability. Initial growth and MSC expansion by PI-PL and PL controls were comparable either using different MSC populations or in head to head experiments. Moreover, PI-PL and PL control sustained similar MSC growth of frozen/thawed MSC. Multilineage differentiation of PI-derived and PI-PL-derived MSC were maintained in any MSC cultures as well as their immunoregulatory properties. Finally, no direct impact of PI on growth factor concentration and MSC growth support was observed, whereas the capacity of FBS to sustain MSC expansion in basic medium was irrelevant as compared to PL and PI-PL. Conclusion The replacement of animal additives with human supplements is a basic issue in MSC ex vivo production. PI-PL represents a standardized, plasma-poor, human preparation which appears as a safe and good candidate to stimulate MSC growth in clinical-scale cultures. PMID:24467837

  7. Hematologic and serum chemistry reference intervals for free-ranging lions (Panthera leo).

    PubMed

    Maas, Miriam; Keet, Dewald F; Nielen, Mirjam

    2013-08-01

    Hematologic and serum chemistry values are used by veterinarians and wildlife researchers to assess health status and to identify abnormally high or low levels of a particular blood parameter in a target species. For free-ranging lions (Panthera leo) information about these values is scarce. In this study 7 hematologic and 11 serum biochemistry values were evaluated from 485 lions from the Kruger National Park, South Africa. Significant differences between sexes and sub-adult (≤ 36 months) and adult (>36 months) lions were found for most of the blood parameters and separate reference intervals were made for those values. The obtained reference intervals include the means of the various blood parameter values measured in captive lions, except for alkaline phosphatase in the subadult group. These reference intervals can be utilized for free-ranging lions, and may likely also be used as reference intervals for captive lions. Copyright © 2013 Elsevier Ltd. All rights reserved.

  8. Community exposure to hazardous site remediation in rural New Zealand: an exposed-referent study of serum dioxins and health effects.

    PubMed

    McBride, David; Lovelock, Kirsten; Shepherd, Daniel; Dirks, Kim; Welch, David; Gray, Andrew

    2016-10-01

    The New Zealand Ministry of Health responded to community concern about dioxin exposure during on-site remediation of a pesticide-contaminated rural area by commissioning this exposed-referent study of serum dioxins and health in local residents. All 200 residents were eligible, with age and sex matching to demographically comparable referents. Face-to-face interviews included questions on health status, health-related quality of life (HRQOL) and perceptions about community consultation. Thirty serum samples were obtained, eligibility being based on likelihood of exposure and age. Both HRQOL and serum outcomes were analysed by the appropriate regression methods. Of 200 eligible residents, 139 (69.5%) participated, with 139 matched referents. Mapua residents had lower physical and psychological HRQOL scores, but no difference in health status. 2,3,7,8 TCDD was below the limit of detection in the majority of all serum samples, with some congeners being higher in referents. Perceptions of the communication process were equivocal. Both dioxin levels and measures of health did not differ significantly between the exposed community and controls. Implications for public health: The results suggest neither significant dioxin exposure nor community health effects. Oversight by expert panel with health expertise, allied to sound communication, may have helped the community understand the risks. © 2016 Public Health Association of Australia.

  9. Achievements and Future Directions of the APFCB Mass Spectrometry Harmonisation Project on Serum Testosterone.

    PubMed

    Greaves, Ronda F; Ho, Chung S; Hoad, Kirsten E; Joseph, John; McWhinney, Brett; Gill, Janice P; Koal, Therese; Fouracre, Chris; Iu, Heidi P; Cooke, Brian R; Boyder, Conchita; Pham, Hai T; Jolly, Lisa M

    2016-05-01

    As an outcome of the 2010 Asian Pacific Conference for Chromatography and Mass Spectrometry in Hong Kong, a collaborative working group was formed to promote the harmonisation of mass spectrometry methods. The Mass Spectrometry Harmonisation Working Group resides under the combined auspices of the Asia-Pacific Federation for Clinical Biochemistry and Laboratory Medicine (APFCB) and the Australasian Association of Clinical Biochemists (AACB). A decision was made to initially focus attention on serum steroids due to the common interest of members in this area; with the first steroid to assess being testosterone. In principle, full standardisation with traceability should be achievable for all steroids as they are small compounds with defined molecular weight and structure. In order to achieve this we need certified reference materials, reference methods, reference laboratories, reference intervals and external quality assurance programs; each being an important pillar in the process. When all the pillars are present, such as for serum testosterone, it is feasible to fully standardise the liquid chromatography - tandem mass spectrometry (LC-MS/MS) methods. In a collaborative process with interested stakeholders, we commenced on a pathway to provide ongoing assessment and seek opportunities for improvement in the LC-MS/MS methods for serum steroids. Here we discuss the outcomes to date and major challenges related to the accurate measurement of serum steroids with a focus on serum testosterone.

  10. Winter Roadway Maintenance Material Enhancers (Field) Evaluation

    DOT National Transportation Integrated Search

    2018-04-06

    In this study, the performance and cost analysis of four deicers products, i.e., Aqua Salina (AS), Beet Heet (BH), Green Blast (GB), Magic Minus Zero (MMZ), and two references, Rock Salt (RS) and/or Salt Brine (SB) were evaluated through parking lot ...

  11. Multiple sclerosis: Presence of serum antibodies to lipids and predominance of cholesterol recognition.

    PubMed

    Jurewicz, Anna; Domowicz, Malgorzata; Galazka, Grazyna; Raine, Cedric S; Selmaj, Krzysztof

    2017-10-01

    A lot of available data on lipid immunology in multiple sclerosis (MS) have been derived from studies using synthetic lipids, therefore the role of lipids in the immunopathogenesis of MS remains poorly defined. The present study on the lipid response in MS was performed on native lipids from autopsied brain tissue. For this, lipid fractions (n = 9) were prepared from MS (n = 3) and control (n = 2) white matter according to the Folch procedure and were characterized depending on their solubility in chloroform/methanol. TLC showed that, in brain from MS cases, neutral lipids were rich in cholesterol and cholesterol esters while lipids from control brains displayed a predominance of phospholipids. MS serum IgG and IgM were found to bind to MS brain lipid fractions with a higher efficacy (p < 0.05) than the control serum. F(ab) 2 fractionation revealed that MS serum IgG binding depended on a specific antibody-type of recognition. Pre-adsorption of serum with cholesterol, galactocerebrosides, sulfitides, and phosphatidylinositol prior to ELISA with MS brain lipids, showed that cholesterol diminished IgG and IgM binding up to 70%. Experiments with synthetic lipids confirmed the predominance of cholesterol binding by MS serum. Our results demonstrate that IgG and IgM fractions from MS serum specifically and predominantly recognize native cholesterol and cholesterol esters isolated from the brain tissue of patients with MS. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  12. The impact of change in albumin assay on reference intervals, prevalence of 'hypoalbuminaemia' and albumin prescriptions.

    PubMed

    Coley-Grant, Deon; Herbert, Mike; Cornes, Michael P; Barlow, Ian M; Ford, Clare; Gama, Rousseau

    2016-01-01

    We studied the impact on reference intervals, classification of patients with hypoalbuminaemia and albumin infusion prescriptions on changing from a bromocresol green (BCG) to a bromocresol purple (BCP) serum albumin assay. Passing-Bablok regression analysis and Bland-Altman plot were used to compare Abbott BCP and Roche BCG methods. Linear regression analysis was used to compare in-house and an external laboratory Abbott BCP serum albumin results. Reference intervals for Abbott BCP serum albumin were derived in two different laboratories using pathology data from adult patients in primary care. Prescriptions for 20% albumin infusions were compared one year before and one year after changing the albumin method. Abbott BCP assay had a negative bias of approximately 6 g/L compared with Roche BCG method.There was good agreement (y = 1.04 x - 1.03; R(2 )= 0.9933) between in-house and external laboratory Abbott BCP results. Reference intervals for the serum albumin Abbott BCP assay were 31-45 g/L, different to those recommended by Pathology Harmony and the manufacturers (35-50 g/L). Following the change in method there was a large increase in the number of patients classified as hypoalbuminaemic using Pathology Harmony references intervals (32%) but not when retrospectively compared to locally derived reference intervals (16%) compared with the previous year (12%). The method change was associated with a 44.6% increase in albumin prescriptions. This equated to an annual increase in expenditure of £35,234. We suggest that serum albumin reference intervals be method specific to prevent misclassification of albumin status in patients. Change in albumin methodology may have significant impact on hospital resources. © The Author(s) 2015.

  13. Serum ARCHITECT PIVKA-II reference interval in healthy Chinese adults: Sub-analysis from a prospective multicenter study.

    PubMed

    Yan, Cunling; Hu, Jian; Yang, Jia; Chen, Zhaoyun; Li, Huijun; Wei, Lianhua; Zhang, Wei; Xing, Hao; Sang, Guoyao; Wang, Xiaoqin; Han, Ruilin; Liu, Ping; Li, Zhihui; Li, Zhiyan; Huang, Ying; Jiang, Li; Li, Shunjun; Dai, Shuyang; Wang, Nianyue; Yang, Yongfeng; Ma, Li; Soh, Andrew; Beshiri, Agim; Shen, Feng; Yang, Tian; Fan, Zhuping; Zheng, Yijie; Chen, Wei

    2018-04-01

    Protein induced by vitamin K absence or antagonist-II (PIVKA-II) has been widely used as a biomarker for liver cancer diagnosis in Japan for decades. However, the reference intervals for serum ARCHITECT PIVKA-II have not been established in the Chinese population. Thus, this study aimed to measure serum PIVKA-II levels in healthy Chinese subjects. This is a sub-analysis from the prospective, cross-sectional and multicenter study (ClinicalTrials.gov Identifier: NCT03047603). A total of 892 healthy participants (777 Han and 115 Uygur) with complete health checkup results were recruited from 7 regional centers in China. Serum PIVKA-II level was measured by ARCHITECT immunoassay. All 95% reference ranges were estimated by nonparametric method. The distribution of PIVKA-II values showed significant difference with ethnicity and sex, but not age. The 95% reference range of PIVKA-II was 13.62-40.38 mAU/ml in Han Chinese subjects and 15.16-53.74 mAU/ml in Uygur subjects. PIVKA-II level was significantly higher in males than in females (P < 0.001). The 95% reference range of PIVKA-II was 15.39-42.01 mAU/ml in Han males while 11.96-39.13 mAU/ml in Han females. The reference interval of serum PIVKA-II on the Architect platform was established in healthy Chinese adults. This will be valuable for future clinical and laboratory studies performed using the Architect analyzer. Different ethnic backgrounds and analytical methods underline the need for redefining the reference interval of analytes such as PIVKA-II, in central laboratories in different countries. Copyright © 2018 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  14. Reference intervals for serum biochemistries of molting Pacific Black Brant (Branta bernicla nigricans) in Northern Alaska, USA

    USGS Publications Warehouse

    Franson, J. Christian; Flint, Paul L.; Schmutz, Joel A.

    2017-01-01

    We determined reference intervals for nine serum biochemistries in samples from 329 molting, after-hatch-year, Pacific Black Brant (Branta bernicla nigricans) in Alaska, US. Cholesterol and nonesterified fatty acids differed by sex, but no other differences were noted.

  15. Exploring Novel Spintronic Responses from Advanced Functional Organic Materials

    DTIC Science & Technology

    2015-08-10

    under 365 nm handheld UV lamp before (left) and after (right) writing letters with AA solution as ink. In summary, we could demonstrate a novel...to UV (360 nm) for 20 min, and the octadecyltrichlorosilane (OTS) treatment was carried out in an OTS vapor chamber (80 °C, vacuum, 2 h 30 min...serum to 20 mM in food and pharmaceuticals.5-7 A lot of analytical detection methods for AA have been developed including electrophoresis,8 UV -Vis

  16. A Rift Valley Fever Vaccine Trial. 1. Side Effects and Serologic Response Over a Six-Month Follow-Up

    DTIC Science & Technology

    1982-01-01

    strep - injection. One volunteer was excluded tomycin and 10 per cent fetal calf serum. from the trial following detection of se- The cells were...ml swelling, induration) were recorded. Each of lot 1. Three additional individuals who symptom was individually scored on a received the 1 ml dose...plaque-forming units of the tivities, nasal discharge, sore throat , ZH501 strain of Rift Valley fever virus cough, nausea or anorexia, vomiting, and and

  17. Comparative plasma and tissue distribution of Sun Pharma's generic doxorubicin HCl liposome injection versus Caelyx® (doxorubicin HCl liposome injection) in syngeneic fibrosarcoma-bearing BALB/c mice and Sprague-Dawley rats.

    PubMed

    Burade, Vinod; Bhowmick, Subhas; Maiti, Kuntal; Zalawadia, Rishit; Jain, Deepak; Rajamannar, Thennati

    2017-05-01

    The liposomal formulation of doxorubicin [doxorubicin (DXR) hydrochloride (HCl) liposome injection, Caelyx ® ] alters the tissue distribution of DXR as compared with nonliposomal DXR, resulting in an improved benefit-risk profile. We conducted studies in murine models to compare the plasma and tissue distribution of a proposed generic DXR HCl liposome injection developed by Sun Pharmaceuticals Industries Limited (SPIL DXR HCl liposome injection) with Caelyx ® . The plasma and tissue distributions of the SPIL and reference DXR HCl liposome injections were compared in syngeneic fibrosarcoma-bearing BALB/c mice and Sprague-Dawley rats. Different batches and different lots of the same batch of the reference product were also compared with each other. The SPIL and reference DXR HCl liposome injections exhibited generally comparable plasma and tissue distribution profiles in both models. While minor differences were observed between the two products in some tissues, different batches and lots of the reference product also showed some differences in the distribution of various analytes in some tissues. The ratios of estimated free to encapsulated DXR for plasma and tissue were generally comparable between the SPIL and reference DXR HCl liposome injections in both models, indicating similar extents of absorption into the tissues and similar rates of drug release from liposomes. The plasma and tissue distribution profiles of the SPIL and reference DXR HCl liposome injections were shown to be generally comparable. Inconsistencies between the products observed in some tissues were thought to be due to biological variation.

  18. Serum bicarbonate and mortality in adults in NHANES III

    PubMed Central

    Raphael, Kalani L.; Zhang, Yingying; Wei, Guo; Greene, Tom; Cheung, Alfred K.; Beddhu, Srinivasan

    2013-01-01

    Background Low serum bicarbonate concentration is a risk factor for death in people with chronic kidney disease (CKD). Whether low serum bicarbonate is a mortality risk factor for people without CKD is unknown. Methods National Health and Nutrition Examination Survey III (NHANES III) adult participants were categorized into one of four serum bicarbonate categories: <22, 22–25, 26–30 and ≥31 mM. Cox models were used to determine the hazards of death in each serum bicarbonate category, using 26–30 mM as the reference group, in the (i) entire population, (ii) non-CKD subgroup and (iii) CKD subgroup. Results After adjusting for age, gender, race, estimated glomerular filtration rate, albuminuria, diuretic use, smoking, C-reactive protein, cardiovascular disease, protein intake, diabetes, hypertension, body mass index, lung disease and serum albumin, the hazards of death in the <22 mM serum bicarbonate category were 1.75 (95% CI: 1.12–2.74), 1.56 (95% CI: 0.78–3.09) and 2.56 (95% CI: 1.49–4.38) in the entire population, non-CKD subgroup and CKD subgroup, respectively, compared with the reference group. Hazard ratios in the other serum bicarbonate categories in the entire population and non-CKD and CKD subgroups did not differ from the reference group. Conclusions Among the NHANES III participants, low serum bicarbonate was not observed to be a strong predictor of mortality in people without CKD. However, low serum bicarbonate was associated with a 2.6-fold increased hazard of death in people with CKD. PMID:23348878

  19. [Treatment of primary hypothyroidism in adult patients].

    PubMed

    Salmela, Pasi; Metso, Saara; Moilanen, Leena; Niskanen, Leo; Nuutila, Pirjo; Schalin-Jäntti, Camilla

    2016-01-01

    The diagnosis of hypothyroidism is based on the findings of an increased serum TSH (above the reference range) and decreased serum free T4 (below the reference range) concentration. Treatment of subclinical hypothyroidism is indicated if serum THS is above 10 mU/l. For less severe forms of subclinical hypothyroidism, the treatment should be individually tailored. The treatment of choice is synthetic human levothyroxine. The goals for treatment are amelioration of symptoms and normalization of TSH and free T4 concentrations.

  20. Normal reference intervals and the effects of time and feeding on serum bile acid concentrations in llamas.

    PubMed

    Andreasen, C B; Pearson, E G; Smith, B B; Gerros, T C; Lassen, E D

    1998-04-01

    Fifty clinically healthy llamas, 0.5-13 years of age (22 intact males, 10 neutered males, 18 females), with no biochemical evidence of liver disease or hematologic abnormalities, were selected to establish serum bile acid reference intervals. Serum samples submitted to the clinical pathology laboratory were analyzed using a colorimetric enzymatic assay to establish bile acid reference intervals. A nonparametric distribution of llama bile acid concentrations was 1-23 micromol/liter for llamas >1 year of age and 10-44 micromol/liter for llamas < or = 1 year of age. A significant difference was found between these 2 age groups. No correlation was detected between gender and bile acid concentrations. The reference intervals were 1.1-22.9 micromol/liter for llamas >1 year of age and 1.8-49.8 micromol/liter for llamas < or = 1 year of age. Additionally, a separate group of 10 healthy adult llamas (5 males, 5 females, 5-11 years of age) without biochemical or hematologic abnormalities was selected to assess the effects of feeding and time intervals on serum bile acid concentrations. These 10 llamas were provided fresh water and hay ad libitum, and serum samples were obtained via an indwelling jugular catheter hourly for 11 hours. Llamas were then kept from food overnight (12 hours), and subsequent samples were taken prior to feeding (fasting baseline time, 23 hours after trial initiation) and postprandially at 0.5, 1, 2, 4, and 8 hours. In feeding trials, there was no consistent interaction between bile acid concentrations and time, feeding, or 12-hour fasting. Prior feeding or time of day did not result in serum bile acid concentrations outside the reference interval, but concentrations from individual llamas varied within this interval over time.

  1. Cure of tuberculosis despite serum concentrations of antituberculosis drugs below published reference ranges.

    PubMed

    Meloni, Monica; Corti, Natascia; Müller, Daniel; Henning, Lars; Gutteck, Ursula; von Braun, Amrei; Weber, Rainer; Fehr, Jan

    2015-01-01

    Therapeutic target serum concentrations of first-line antituberculosis drugs have not been well defined in clinical studies in tuberculosis (TB) patients. We retrospectively investigated the estimated maximum serum concentrations (eC max) of antituberculosis drugs and clinical outcome of TB patients with therapeutic drug monitoring performed between 2010-2012 at our institution, and follow-up until March 2014. The eC max was defined as the highest serum concentration during a sampling period (2, 4 and 6 hours after drug ingestion). We compared the results with published eC max values, and categorised them as either "within reference range", "low eC max", or "very low eC max".Low/very low eC max-levels were defined as follows: isoniazid 2-3/<2 mg/l, rifampicin 4-8/<4 mg/l, rifabutin 0.2-0.3/<0.2 mg/l, ethambutol 1-2/<0.1 mg/l and pyrazinamide <20 mg/l. Concentrations of antituberculosis drugs in 175 serum samples of 17 patients with TB were analysed. In 12 (71%) patients, multiple therapeutic drug monitoring samples were collected over time, in 5 (29%) patients only one sample was available for therapeutic drug monitoring. Overall, 94% of all patients had at least one low antituberculosis drug concentration. Overall, 64% of all eC max levels were classified as "low" or "very low". The eC max was below the relevant reference range in 80% of isoniazid, 95% of rifampicin, 30% of pyrazinamide, and 30% of ethambutol measurements. All but one patient were cured of tuberculosis. Although many antituberculosis drug serum concentrations were below the widely used reference ranges, 16 of 17 patients were cured of tuberculosis. These results challenge the use of the published reference ranges for therapeutic drug monitoring.

  2. Reference ranges for serum total and monomeric prolactin for the current generation Abbott Architect assay.

    PubMed

    Whitehead, S J; Cornes, M P; Ford, C; Gama, R

    2015-01-01

    Exclusion of macroprolactinaemia, a well-recognised interference, as the cause of hyperprolactinaemia is essential to avoid potential misdiagnosis and mismanagement of patients. We have derived gender-specific serum total and post-polyethylene glycol (PEG) precipitation monomeric reference ranges for the recently re-standardised Abbott Architect prolactin assay. Prolactin was measured in serum samples obtained from males (n=49) and females (n=52) using the current Abbott Architect immunoassay pre- and post-PEG precipitation. Gender-specific reference ranges were derived for total and monomeric (post-PEG) prolactin. Routine patients' samples (n=175) with a serum total prolactin >700 mIU/L were screened for macroprolactinaemia to assess classification compared with our previous post-PEG precipitation percentage recovery-based approach. Reference ranges for serum total prolactin were 58-419 mIU/L (male) and 63-561 mIU/L (female). Male and female monomeric prolactin reference ranges were 32-309 mIU/L and 39-422 mIU/L, respectively. Mean (SD) post-PEG percentage recovery of the IS 84/500 prolactin standard was 80 (2.3)%. Of 175 patients' samples screened for macroprolactinaemia, 149 had monomeric prolactin concentrations (median monomeric prolactin=1035 mIU/L; median recovery=83%) above the gender-specific reference range. Monomeric prolactin concentrations (median monomeric prolactin=162 mIU/L; median recovery=20%) in the remaining 26 were within the reference ranges. One patient classified as macroprolactin positive and another classified as macroprolactin negative would not have been identified as such using the previous recovery-based approach. The use of post-PEG monomeric reference ranges not only identifies hyperprolactinaemia due solely to macroprolactinaemia but has the added advantage of identifying patients who have simultaneous true monomeric hyperprolactinaemia and elevated concentrations of macroprolactin. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  3. Perspective: The Case for an Evidence-Based Reference Interval for Serum Magnesium: The Time Has Come.

    PubMed

    Costello, Rebecca B; Elin, Ronald J; Rosanoff, Andrea; Wallace, Taylor C; Guerrero-Romero, Fernando; Hruby, Adela; Lutsey, Pamela L; Nielsen, Forrest H; Rodriguez-Moran, Martha; Song, Yiqing; Van Horn, Linda V

    2016-11-01

    The 2015 Dietary Guidelines Advisory Committee indicated that magnesium was a shortfall nutrient that was underconsumed relative to the Estimated Average Requirement (EAR) for many Americans. Approximately 50% of Americans consume less than the EAR for magnesium, and some age groups consume substantially less. A growing body of literature from animal, epidemiologic, and clinical studies has demonstrated a varied pathologic role for magnesium deficiency that includes electrolyte, neurologic, musculoskeletal, and inflammatory disorders; osteoporosis; hypertension; cardiovascular diseases; metabolic syndrome; and diabetes. Studies have also demonstrated that magnesium deficiency is associated with several chronic diseases and that a reduced risk of these diseases is observed with higher magnesium intake or supplementation. Subclinical magnesium deficiency can exist despite the presentation of a normal status as defined within the current serum magnesium reference interval of 0.75-0.95 mmol/L. This reference interval was derived from data from NHANES I (1974), which was based on the distribution of serum magnesium in a normal population rather than clinical outcomes. What is needed is an evidenced-based serum magnesium reference interval that reflects optimal health and the current food environment and population. We present herein data from an array of scientific studies to support the perspective that subclinical deficiencies in magnesium exist, that they contribute to several chronic diseases, and that adopting a revised serum magnesium reference interval would improve clinical care and public health. © 2016 American Society for Nutrition.

  4. Perspective: The Case for an Evidence-Based Reference Interval for Serum Magnesium: The Time Has Come12345

    PubMed Central

    Elin, Ronald J; Rosanoff, Andrea; Lutsey, Pamela L; Nielsen, Forrest H; Rodriguez-Moran, Martha

    2016-01-01

    The 2015 Dietary Guidelines Advisory Committee indicated that magnesium was a shortfall nutrient that was underconsumed relative to the Estimated Average Requirement (EAR) for many Americans. Approximately 50% of Americans consume less than the EAR for magnesium, and some age groups consume substantially less. A growing body of literature from animal, epidemiologic, and clinical studies has demonstrated a varied pathologic role for magnesium deficiency that includes electrolyte, neurologic, musculoskeletal, and inflammatory disorders; osteoporosis; hypertension; cardiovascular diseases; metabolic syndrome; and diabetes. Studies have also demonstrated that magnesium deficiency is associated with several chronic diseases and that a reduced risk of these diseases is observed with higher magnesium intake or supplementation. Subclinical magnesium deficiency can exist despite the presentation of a normal status as defined within the current serum magnesium reference interval of 0.75–0.95 mmol/L. This reference interval was derived from data from NHANES I (1974), which was based on the distribution of serum magnesium in a normal population rather than clinical outcomes. What is needed is an evidenced-based serum magnesium reference interval that reflects optimal health and the current food environment and population. We present herein data from an array of scientific studies to support the perspective that subclinical deficiencies in magnesium exist, that they contribute to several chronic diseases, and that adopting a revised serum magnesium reference interval would improve clinical care and public health. PMID:28140318

  5. Identification of Reliable Reference Genes for Quantification of MicroRNAs in Serum Samples of Sulfur Mustard-Exposed Veterans.

    PubMed

    Gharbi, Sedigheh; Shamsara, Mehdi; Khateri, Shahriar; Soroush, Mohammad Reza; Ghorbanmehr, Nassim; Tavallaei, Mahmood; Nourani, Mohammad Reza; Mowla, Seyed Javad

    2015-01-01

    In spite of accumulating information about pathological aspects of sulfur mustard (SM), the precise mechanism responsible for its effects is not well understood. Circulating microRNAs (miRNAs) are promising biomarkers for disease diagnosis and prognosis. Accurate normalization using appropriate reference genes, is a critical step in miRNA expression studies. In this study, we aimed to identify appropriate reference gene for microRNA quantification in serum samples of SM victims. In this case and control experimental study, using quantitative real-time polymerase chain reaction (qRT-PCR), we evaluated the suitability of a panel of small RNAs including SNORD38B, SNORD49A, U6, 5S rRNA, miR-423-3p, miR-191, miR-16 and miR-103 in sera of 28 SM-exposed veterans of Iran-Iraq war (1980-1988) and 15 matched control volunteers. Different statistical algorithms including geNorm, Normfinder, best-keeper and comparative delta-quantification cycle (Cq) method were employed to find the least variable reference gene. miR-423-3p was identified as the most stably expressed reference gene, and miR- 103 and miR-16 ranked after that. We demonstrate that non-miRNA reference genes have the least stabil- ity in serum samples and that some house-keeping miRNAs may be used as more reliable reference genes for miRNAs in serum. In addition, using the geometric mean of two reference genes could increase the reliability of the normalizers.

  6. 7 CFR 43.102 - Definitions.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... SAMPLING PLANS Definitions § 43.102 Definitions. Statistical and inspection or sampling terms and their... probability of acceptance (Pa) for the Limited Quality (LQ) lots. The consumer protection is 90 percent in... the standards of this subpart that have a ten percent probability of acceptance are referred to as a...

  7. Serum TSH reference interval in healthy Finnish adults using the Abbott Architect 2000i Analyzer.

    PubMed

    Schalin-Jäntti, Camilla; Tanner, Pirjo; Välimäki, Matti J; Hämäläinen, Esa

    2011-07-01

    Current serum TSH reference intervals have been criticized as they were established from unselected background populations. A special concern is that the upper limit, which defines subclinical hypothyroidism, is too high. The objective was to redefine the TSH reference interval in the adult Finnish population. The current reference interval for the widely used Abbott Architect method in Finland is 0.4-4.0 mU/L. Serum TSH and free T4 concentrations were derived from 606 healthy, non-pregnant, 18-91-year-old Finns from the Nordic Reference Interval Project (NORIP) and the possible effects of age, sex and thyroid peroxidase antibody (TPOAb) status were evaluated. After excluding TPOAb-positive subjects and outliers, a reference population of 511 subjects was obtained. In the reference population, no statistically significant gender- or age-specific differences in mean TSH (1.55 ± 3.30 mU/L) or TSH reference intervals were observed. The new reference interval was 0.5-3.6 mU/L (2.5th-97.5th percentiles). The current upper TSH reference limit is 10% too high. A TSH > 3.6 mU/L, confirmed with a repeat TSH sampling, may indicate subclinical hypothyroidism. Differences in ethnicity, regional iodine-intake and analytical methods underline the need for redefining the TSH reference interval in central laboratories in different countries.

  8. Space logistics simulation: Launch-on-time

    NASA Technical Reports Server (NTRS)

    Nii, Kendall M.

    1990-01-01

    During 1989-1990 the Center for Space Construction developed the Launch-On-Time (L-O-T) Model to help asses and improve the likelihood of successfully supporting space construction requiring multi-logistic delivery flights. The model chose a reference by which the L-O-T probability and improvements to L-O-T probability can be judged. The measure of improvement was chosen as the percent reduction in E(S(sub N)), the total expected amount of unscheduled 'hold' time. We have also previously developed an approach to determining the reduction in E(S(sub N)) by reducing some of the causes of unscheduled holds and increasing the speed at which the problems causing the holds may be 'fixed.' We provided a mathematical (binary linear programming) model for measuring the percent reduction in E(S(sub N)) given such improvements. In this presentation we shall exercise the model which was developed and draw some conclusions about the following: methods used, data available and needed, and make suggestions for areas of improvement in 'real world' application of the model.

  9. Serum reference interval of ARCHITECT alpha-fetoprotein in healthy Chinese Han adults: Sub-analysis of a prospective multi-center study.

    PubMed

    Yan, Cunling; Yang, Jia; Wei, Lianhua; Hu, Jian; Song, Jiaqi; Wang, Xiaoqin; Han, Ruilin; Huang, Ying; Zhang, Wei; Soh, Andrew; Beshiri, Agim; Fan, Zhuping; Zheng, Yijie; Chen, Wei

    2018-02-01

    Alpha-fetoprotein (AFP) has been widely used in clinical practice for decades. However, large-scale survey of serum reference interval for ARCHITECT AFP is still absent in Chinese population. This study aimed to measure serum AFP levels in healthy Chinese Han subjects, which is a sub-analysis of an ongoing prospective, cross-sectional, multi-center study (ClinicalTrials.gov Identifier: NCT03047603). This analysis included a total of 530 participants (41.43±12.14years of age on average, 48.49% males), enrolled from 5 regional centers. Serum AFP level was measured by ARCHITECT immunoassay. Statistical analysis was performed using SAS 9.4 and R software. AFP distribution did not show significant correlation with age or sex. The overall median and interquartile range of AFP was 2.87 (2.09, 3.83) ng/mL. AFP level did not show a trend of increasing with age. The new reference interval was 2.0-7.07ng/mL (LOQ- 97.5th percentiles). The reference interval for ARCHITECT AFP is updated with the data of adequate number of healthy Han adults. This new reference interval is more practical and applicable in Chinese adults. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  10. Roles of circulating WNT-signaling proteins and WNT-inhibitors in human adiposity, insulin resistance, insulin secretion, and inflammation.

    PubMed

    Almario, R U; Karakas, S E

    2015-02-01

    Wingless-type MMTV integration site family member (WNT) signaling and WNT-inhibitors have been implicated in regulation of adipogenesis, insulin resistance, pancreatic function, and inflammation. Our goal was to determine serum proteins involved in WNT signaling (WNT5 and WISP2) and WNT inhibition (SFRP4 and SFRP5) as they relate to obesity, serum adipokines, insulin resistance, insulin secretion, and inflammation in humans. Study population comprised 57 insulin resistant women with polycystic ovary syndrome (PCOS) and 27 reference women. In a cross-sectional study, blood samples were obtained at fasting, during oral, and frequently sampled intravenous glucose tolerance tests. Serum WNT5, WISP2, and SFRP4 concentrations did not differ between PCOS vs. reference women. Serum WNT5 correlated inversely with weight both in PCOS and reference women, and correlated directly with insulin response during oral glucose tolerance test in PCOS women. Serum WISP2 correlated directly with fatty acid binding protein 4. Serum SFRP5 did not differ between obese (n=32) vs. nonobese (n=25) PCOS women, but reference women had lower SFRP5 (p<5×10(-6) as compared to both PCOS groups). Serum SFRP5 correlated inversely with IL-1β, TNF-α, cholesterol, and apoprotein B. These findings demonstrated that WNT5 correlated inversely with adiposity and directly with insulin response, and the WNT-inhibitor SFRP5 may be anti-inflammatory. Better understanding of the role of WNT signaling in obesity, insulin resistance, insulin secretion, lipoprotein metabolism, and inflammation is important for prevention and treatment of metabolic syndrome, diabetes and cardiovascular disease. © Georg Thieme Verlag KG Stuttgart · New York.

  11. Fundamental Importance of Reference Glucose Analyzer Accuracy for Evaluating the Performance of Blood Glucose Monitoring Systems (BGMSs).

    PubMed

    Bailey, Timothy S; Klaff, Leslie J; Wallace, Jane F; Greene, Carmine; Pardo, Scott; Harrison, Bern; Simmons, David A

    2016-07-01

    As blood glucose monitoring system (BGMS) accuracy is based on comparison of BGMS and laboratory reference glucose analyzer results, reference instrument accuracy is important to discriminate small differences between BGMS and reference glucose analyzer results. Here, we demonstrate the important role of reference glucose analyzer accuracy in BGMS accuracy evaluations. Two clinical studies assessed the performance of a new BGMS, using different reference instrument procedures. BGMS and YSI analyzer results were compared for fingertip blood that was obtained by untrained subjects' self-testing and study staff testing, respectively. YSI analyzer accuracy was monitored using traceable serum controls. In study 1 (N = 136), 94.1% of BGMS results were within International Organization for Standardization (ISO) 15197:2013 accuracy criteria; YSI analyzer serum control results showed a negative bias (-0.64% to -2.48%) at the first site and a positive bias (3.36% to 6.91%) at the other site. In study 2 (N = 329), 97.8% of BGMS results were within accuracy criteria; serum controls showed minimal bias (<0.92%) at both sites. These findings suggest that the ability to demonstrate that a BGMS meets accuracy guidelines is influenced by reference instrument accuracy. © 2016 Diabetes Technology Society.

  12. Development of a candidate reference measurement procedure for the analysis of cortisol in human serum samples by isotope dilution-gas chromatography-mass spectrometry.

    PubMed

    Kawaguchi, Migaku; Takatsu, Akiko

    2009-08-01

    A candidate reference measurement procedure involving isotope dilution coupled with gas chromatography-mass spectrometry (GC-MS) has been developed and critically evaluated. An isotopically labeled internal standard, cortisol-d(2), was added to a serum sample. After equilibration, solid-phase extractions (SPE) for sample preparation and derivatization with heptafluorobutyric anhydride (HFBA) were performed for GC-MS analysis. The limit of detection (LOD) and the limit of quantification (LOQ) were 5 and 20 ng g(-1), respectively. The recovery of the added cortisol ranged from 99.8 to 101.0%. Excellent precision was obtained with a within-day variation (RSD) of 0.7% for GC-MS analysis. The accuracy of the measurement was evaluated by comparing of results of this reference measurement procedure on lyophilized human serum reference materials for cortisol (European Reference Materials (ERM)-DA 192) as Certified Reference Materials (CRMs). The results of this method for total cortisol agreed with the certified values within some uncertainty. This method, which demonstrates simply, easy, good accuracy, high precision, and is free from interferences from structural analogues, qualifies as a reference measurement procedure.

  13. Correlation of serum androgens and pituitary hormone levels with serum PSA less than 2.5 ng/ml.

    PubMed

    Sofikerim, Mustafa; Oruç, Ozgür; Eskicorapci, Sadettin; Guliyev, Fuat; Ozen, Haluk

    2007-07-27

    The aim of this clinical study was to determine whether there is a relationship between total serum testosterone, free testosterone, FSH (Follicle-Stimulating Hormone), LH (Luteinizing Hormone) and serum prostate specific antigen (PSA) levels. We postulated that such a correlation existed then the use of hormone specific reference ranges might enhance the usefullness of PSA concentrations <2.5 ng/mL as a marker for prostate cancer. Prior to digital rectal examination, serum was obtained from all patients between 8.30-10:00 AM for hormone and PSA concentrations. The study was performed on 210 male patients >40 years of age visiting our urology outpatient clinics. PSA was correlated to age (r = 0.23, p = 0.019), but there none between serum testosterone and age. No significant correlation was noted between testosterone or free testosterone and serum PSA levels, and none between serum FSH or LH and PSA. In age specific reference groups (41-49; 50-59; 60-69 years), we found no significant correlation between PSA and hormone concentrations. In this population of eugonadal men with serum PSA values less than 2.5 ng/ml, serum androgens and pituitary hormones do not appear to correlate with serum PSA.

  14. Utilization of paramagnetic microparticles for automated isolation of free circulating mRNA as a new tool in prostate cancer diagnostics.

    PubMed

    Fojtu, Michaela; Gumulec, Jaromir; Balvan, Jan; Raudenska, Martina; Sztalmachova, Marketa; Polanska, Hana; Smerkova, Kristyna; Adam, Vojtech; Kizek, Rene; Masarik, Michal

    2014-02-01

    Determination of serum mRNA gained a lot of attention in recent years, particularly from the perspective of disease markers. Streptavidin-modified paramagnetic particles (SMPs) seem an interesting technique, mainly due to possible automated isolation and high efficiency. The aim of this study was to optimize serum isolation protocol to reduce the consumption of chemicals and sample volume. The following factors were optimized: amounts of (i) paramagnetic particles, (ii) oligo(dT)20 probe, (iii) serum, and (iv) the binding sequence (SMPs, oligo(dT)20 , serum vs. oligo(dT)20 , serum and SMPs). RNA content was measured, and the expression of metallothionein-2A as possible prostate cancer marker was analyzed to demonstrate measurable RNA content with ability for RT-PCR detection. Isolation is possible on serum volume range (10-200 μL) without altering of efficiency or purity. Amount of SMPs can be reduced up to 5 μL, with optimal results within 10-30 μL SMPs. Volume of oligo(dT)20 does not affect efficiency, when used within 0.1-0.4 μL. This optimized protocol was also modified to fit needs of automated one-step single-tube analysis with identical efficiency compared to conventional setup. One-step analysis protocol is considered a promising simplification, making RNA isolation suitable for automatable process. © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  15. 40 CFR Appendix B to Part 60 - Performance Specifications

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 6216-98 is the reference for design specifications, manufacturer's performance specifications, and test... representative of a group of monitors produced during a specified period or lot, for conformance with the design... technique and a single analytical program are used. One Run may include results for more than one test...

  16. 40 CFR 160.3 - Definitions.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... under FIFRA sections 3, 4 or 24(c). (2) An application for an experimental use permit under FIFRA... distribution of a pesticide. Batch means a specific quantity or lot of a test, control, or reference substance... to a test system. Control substance means any chemical substance or mixture, or any other material...

  17. 40 CFR 160.3 - Definitions.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... under FIFRA sections 3, 4 or 24(c). (2) An application for an experimental use permit under FIFRA... distribution of a pesticide. Batch means a specific quantity or lot of a test, control, or reference substance... to a test system. Control substance means any chemical substance or mixture, or any other material...

  18. 40 CFR 160.3 - Definitions.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... under FIFRA sections 3, 4 or 24(c). (2) An application for an experimental use permit under FIFRA... distribution of a pesticide. Batch means a specific quantity or lot of a test, control, or reference substance... to a test system. Control substance means any chemical substance or mixture, or any other material...

  19. 40 CFR 160.3 - Definitions.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... under FIFRA sections 3, 4 or 24(c). (2) An application for an experimental use permit under FIFRA... distribution of a pesticide. Batch means a specific quantity or lot of a test, control, or reference substance... to a test system. Control substance means any chemical substance or mixture, or any other material...

  20. 40 CFR 160.3 - Definitions.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... under FIFRA sections 3, 4 or 24(c). (2) An application for an experimental use permit under FIFRA... distribution of a pesticide. Batch means a specific quantity or lot of a test, control, or reference substance... to a test system. Control substance means any chemical substance or mixture, or any other material...

  1. Composition and Potency Characterization of Mycobacterium avium subsp. paratuberculosis Purified Protein Derivatives

    PubMed Central

    Capsel, Randal T.; Thoen, Charles O.; Reinhardt, Timothy A.; Lippolis, John D.; Olsen, Renee; Stabel, Judith R.; Bannantine, John P.

    2016-01-01

    Mycobacterium avium subsp. paratuberculosis (MAP) purified protein derivatives (PPDs) are immunologic reagents prepared from cultured filtrates of the type strain. Traditional production consists of floating culture incubation at 37°C, organism inactivation by autoclaving, coarse filtration, and protein precipitation. Three traditional production PPDs were used in this study including lot 9801, which served as a reference and has been used in the field for decades. Alternative production PPDs (0902A and 0902B), in which the autoclaving step was removed, were also analyzed in this study. SDS-PAGE analysis revealed protein smearing in traditional PPDs, but distinct bands were observed in the alternative PPD preparations. Antibody bound distinct protein bands in the alternative PPDs by immunoblot analysis, whereas an immunoreactive smear was observed with the traditional PPDs. Mass spectrometry identified 194 proteins among three PPD lots representing the two different production methods, ten of which were present in all PPDs examined. Selected proteins identified by mass spectrometry were recombinantly expressed and purified from E. coli and evaluated by the guinea pig potency test. Seven recombinant proteins showed greater erythema as compared to the reference PPD lot 9801 in paired guinea pigs and were able to stimulate interferon-gamma production in blood from Johne’s positive animals. These results suggest that autoclaving culture suspensions is not a necessary step in PPD production and specific proteins could supplant the PPD antigen for intradermal skin testing procedures and for use as in-vitro assay reagents. PMID:27136199

  2. Serum PCB levels and congener profiles among US construction workers

    PubMed Central

    Herrick, Robert F; Meeker, John D; Hauser, Russ; Altshul, Larisa; Weymouth, George A

    2007-01-01

    Background The presence of PCB in caulking (sealant) material found in masonry buildings has been well-documented in several countries. A recent investigation of 24 buildings in the greater Boston area found that 8 buildings had high PCB levels in caulking materials used around window frames and in joints between masonry blocks. Workers removing caulking material have been shown to have elevated serum PCB levels. Methods This project compared serum PCB levels among male workers who installed and/or removed PCB-containing caulking material from buildings in the greater Boston area with reference serum PCB levels from 358 men from the same area. Serum PCB levels were measured in the same laboratory by liquid-liquid extraction, column chromatography clean-up and dual capillary column GC/microECD analysis. Results When the congener profiles were compared between the reference population and the construction workers, the serum levels of the more volatile, lighter PCBs (di-, tri-and tetrachloro, sum of IUPAC# 6–74) were substantially higher among the construction workers. One of the youngest workers had the lowest total serum PCB levels (sum of 57 congeners) of all 6 workers, but the contribution of more volatile (less chlorinated) PCB congeners (#16, 26,28,33,74,66, and 60) was markedly higher than in other 5 workers and reference men. Only this worker was working on a job that involved removing PCB caulking at the time of the blood sampling. Conclusion While the results of this pilot study are based upon small numbers (6 construction workers who handled PCB caulking), the serum PCB levels among the construction workers exceed the referents. Comparison of the congener profiles suggests that there are substantial differences between the construction workers and the general population samples. These differences, and the similarities of profiles among the construction workers strongly suggest that occupational contact with caulking material can be a major source of PCB exposure for construction workers. PMID:17764566

  3. Serum chemistry of free-ranging white whales (Delphinapterus leucas) in Svalbard.

    PubMed

    Tryland, Morten; Thoresen, Stein Istre; Kovacs, Kit M; Lydersen, Christian

    2006-06-01

    Abnormal physiological conditions and diseases can change the concentrations of enzymes, metabolites, and minerals in the body. Serum chemistry information may thus be indicative of a specific disease; interpretation of such information requires knowledge of serum chemistry reference intervals from a seemingly healthy population of the species. The aim of this study was to obtain serum chemistry reference intervals for a population of white whales. Blood samples were collected from 21 free-ranging white whales (beluga; Delphinapterus leucas). The whales were live-captured in nets during 1996-2001 in Storfjorden, Van Mijenfjorden, and Van Keulenfjorden (Svalbard, Norway). While the whales were briefly physically restrained, blood was collected from the caudal vein into vacuum tubes without anticoagulant. The blood was left to clot for 4-6 hours before serum was obtained by centrifugation. The serum samples were then kept at -20 degrees C until analysis. Enzymes (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase [ALP], creatine kinase, lactate dehydrogenase [LDH], amylase, lipase), metabolites (urea, creatinine, bilirubin, cholesterol, triglycerides, nonesterified fatty acids, glucose), and minerals (calcium, phosphate, magnesium, sodium, potassium, chloride) were analyzed in an Advia 1650 System (Bayer, Tarrytown, NY, USA). Cortisol was analyzed in an Immulite One system (Diagnostic Products Corporation, Los Angeles, CA, USA). The major blood proteins (albumin and globulins) were separated by gel electrophoresis in a Beckman Paragon electrophoresis system (Beckman Coulter, Inc., Fullerton, CA, USA). Serum values for all analytes were reported as median and range, and reference intervals were calculated as 10-90th percentiles. Activities of ALP and LDH and cortisol concentration were higher, and protein and bilirubin concentrations were lower compared with those previously reported for white whales from Canada; remaining results were strikingly similar in these 2 white whale populations. These data provide valuable serum chemistry reference intervals for future health assessments of white whales in Svalbard and other white whale populations, as well as captive individuals.

  4. Critical evaluation of connectivity-based point of care testing systems of glucose in a hospital environment.

    PubMed

    Floré, Katelijne M J; Fiers, Tom; Delanghe, Joris R

    2008-01-01

    In recent years a number of point of care testing (POCT) glucometers were introduced on the market. We investigated the analytical variability (lot-to-lot variation, calibration error, inter-instrument and inter-operator variability) of glucose POCT systems in a university hospital environment and compared these results with the analytical needs required for tight glucose monitoring. The reference hexokinase method was compared to different POCT systems based on glucose oxidase (blood gas instruments) or glucose dehydrogenase (handheld glucometers). Based upon daily internal quality control data, total errors were calculated for the various glucose methods and the analytical variability of the glucometers was estimated. The total error of the glucometers exceeded by far the desirable analytical specifications (based on a biological variability model). Lot-to-lot variation, inter-instrument variation and inter-operator variability contributed approximately equally to total variance. As in a hospital environment, distribution of hematocrit values is broad, converting blood glucose into plasma values using a fixed factor further increases variance. The percentage of outliers exceeded the ISO 15197 criteria in a broad glucose concentration range. Total analytical variation of handheld glucometers is larger than expected. Clinicians should be aware that the variability of glucose measurements obtained by blood gas instruments is lower than results obtained with handheld glucometers on capillary blood.

  5. Assessment of reproductive parameters in female Dwarf goat (Capra hircus) on the basis of progesterone profiles.

    PubMed

    Khanum, Shahnaz Adeeb; Hussain, Mujahid; Kausar, Rehana

    2007-12-01

    A study was undertaken to look into the reproductive performance of female Dwarf goats reared under traditional conditions at NIAB Farm, Faisalabad, Pakistan. The serum progesterone profile was used to monitor various reproductive parameters (length of postpartum period, resumption of cyclicity, gestation period, prepartum period, parturition) in two lots of goats. Litter size, birth weight of kids and kidding interval were also observed. Most of the animals conceived within 15-59 days of postpartum period. All the does conceived at first or second estrus. During gestation period, higher levels of progesterone were maintained with wide variations falling in the range of 3-13 ng ml(-1). However, a few days before parturition a decline was noticed at 6+/-0.9 days and it reached to the basal level of 0.1 ng ml(-1) after the completion of parturition process. The length of gestation period was found to be 145.8+/-5 days in the first lot and 145.2+/-4 days in the second lot. A very short kidding interval (203.7+/-46 days) and considerably bigger litter size (1.8+/-0.8) was observed. All the parturitions were normal and a considerable weight gain (8.2+/-0.3 kg) of mothers was recorded during pregnancy. The initial birth weight of kids was averaged as 2.1+/-0.5 kg in the first and 1.6+/-0.2 kg in the second lot. It was concluded that Dwarf goat has short gestation length, postpartum period and kidding interval along with multiple births being common. Due to these factors, its reproductive efficiency can be exploited for efficient goat meat production.

  6. Residual bovine serum albumin (BSA) quantitation in vaccines using automated Capillary Western technology.

    PubMed

    Loughney, John W; Lancaster, Catherine; Ha, Sha; Rustandi, Richard R

    2014-09-15

    Bovine serum albumin (BSA) is a major component of fetal bovine serum (FBS), which is commonly used as a culture medium during vaccine production. Because BSA can cause allergic reactions in humans the World Health Organization (WHO) has set a guidance of 50 ng or less residual BSA per vaccine dose. Vaccine manufacturers are expected to develop sensitive assays to detect residual BSA. Generally, sandwich enzyme-linked immunosorbent assays (ELISA) are used in the industry to detect these low levels of BSA. We report the development of a new improved method for residual BSA detection using the SimpleWestern technology to analyze residual BSA in an attenuated virus vaccine. The method is based on automated Capillary Western and has linearity of two logs, >80% spike recovery (accuracy), intermediate precision of CV <15%, and LOQ of 5.2 ng/ml. The final method was applied to analyze BSA in four lots of bulk vaccine products and was used to monitor BSA clearance during vaccine process purification. Copyright © 2014 Elsevier Inc. All rights reserved.

  7. Modifications to the NIST reference measurement procedure (RMP) for the determination of serum glucose by isotope dilution gas chromatography/mass spectrometry.

    PubMed

    Prendergast, Jocelyn L; Sniegoski, Lorna T; Welch, Michael J; Phinney, Karen W

    2010-07-01

    The definitive method (DM), now known as the reference measurement procedure (RMP), for the analysis of glucose in serum was originally published in 1982 by the National Institute of Standards and Technology (NIST). Over the years the method has been subject to a number of modifications to adapt to newer technologies and simplify sample preparation. We discuss here an adaptation of the method associated with serum glucose measurements using a modified isotope dilution gas chromatography/mass spectrometry (ID-GC/MS) method. NIST has used this modified method to certify the concentrations of glucose in SRM 965b, Glucose in Frozen Human Serum, and SRM 1950, Metabolites in Human Plasma. Comparison of results from the revised method with certified values for existing Standard Reference Materials (SRMs) demonstrated that these modifications have not affected the quality of the measurements, giving both good precision and accuracy, while reducing the sample preparation time by a day and a half.

  8. Acute phase proteins in healthy goats: establishment of reference intervals.

    PubMed

    Heller, Meera C; Johns, Jennifer L

    2015-03-01

    Acute inflammatory processes can trigger increased production of acute phase proteins (APPs) that can be useful biomarkers of inflammation. APPs are diverse and include proteins involved in coagulation, opsonization, iron regulation, and limitation of tissue injury. Haptoglobin, serum amyloid A, and alpha-1 acid glycoprotein have been proposed as useful APPs in goats. APPs can differ markedly by species, therefore species-specific reference intervals and studies are necessary. The objective of this study was to determine species-specific reference intervals for 4 APPs in goats. Haptoglobin, serum amyloid A, lipopolysaccharide binding protein, and alpha-1 acid glycoprotein were measured in in 54 clinically normal adult goats. APPs were measured using goat-specific commercial enzyme-linked immunosorbent assay kits. Results were analyzed by 1-way analysis of variance to compare sexes and breeding status. Reference Value Advisor was used to calculate reference limits according to the IFCC-CLSI guidelines. Only 1 APP was found to vary in healthy animals; serum haptoglobin was increased in lactating animals and decreased in pregnant does in their second trimester when compared with open, nonlactating does. No sex-based differences were seen for any of the APPs measured. We report normal reference intervals for 4 serum APPs that may be useful as disease markers. Haptoglobin should be interpreted with caution in animals with unknown pregnancy status. Further studies are needed to determine whether these APPs are useful biomarkers in goat disease states. © 2015 The Author(s).

  9. Combined dietary and exercise intervention for control of serum cholesterol in the workplace

    NASA Technical Reports Server (NTRS)

    Angotti, C. M.; Chan, W. T.; Sample, C. J.; Levine, M. S.

    2000-01-01

    PURPOSE: To elucidate a potential combined dietary and exercise intervention affect on cardiovascular risk reduction of the National Aeronautics and Space Administration Headquarters employees. DESIGN: A nonexperimental, longitudinal, clinical-chart review study (1987 to 1996) of an identified intervention group and a reference (not a control) group. SETTING: The study group worked in an office environment and participated in the annual medical examinations. SUBJECTS: An intervention group of 858 people with initially elevated serum cholesterol, and a reference group of 963 people randomly sampled from 10% of the study group. MEASURES: Serum cholesterol data were obtained for both groups, respectively, from pre- and postintervention and annual examinations. The reference group was adjusted by statistical exclusion of potential intervention participants. Regression equations (cholesterol vs. study years) for the unadjusted/adjusted reference groups were tested for statistical significance. INTERVENTION: An 8-week individualized, combined dietary and exercise program was instituted with annual follow-ups and was repeated where warranted. RESULTS: Only the unadjusted (but not the adjusted) reference group with initial mean total serum cholesterol levels above 200 mg/dL shows a significant 9-year decline trend and significant beta coefficient tests. An intervention effect is suggested. Mean high density lipoprotein cholesterol rose slightly in the intervention group but was maintained in the reference group. CONCLUSION: With potential design limitations, the NASA intervention program focusing on a high risk group may be associated to some degree, if not fully, with an overall cardiovascular risk profile improvement.

  10. Specific Immunoglobulin (Ig) G Reference Intervals for Common Food, Insect, and Mold Allergens.

    PubMed

    Martins, Thomas B; Bandhauer, Michael E; Wilcock, Diane M; Hill, Harry R; Slev, Patricia R

    2016-12-01

    The clinical utility of serum IgG measurement in the diagnosis of allergy and food-induced hypersensitivity has been largely discredited. Recent studies, however, have shown that specific IgG can inhibit IgE mediated allergies, and may play a role in allergen specific desensitization. Accurate reference intervals for IgG specific allergens have not been widely established and are needed for better interpretation of serum antibody concentrations. In this study we established 64 IgG reference intervals for 48 common food allergens, 5 venoms, and 11 molds. Specific IgG concentrations were determined employing an automated fluorescent enzyme immunoassay on serum samples from 130 normal adults (65 males and 65 females), age range 18-69 y, mean 37.3 y. The lower reference interval limit for all allergens tested (n=64) was <2 mcg/mL. The median upper reference interval value for all 64 allergens was 12.9 mcg/mL, with Tuna (f40) having the lowest upper interval limit at 3.8 mcg/mL, and the mold Setomelanomma rostrate (m8) demonstrating the highest upper interval limit at 131 mcg/L. The considerable variation observed among the upper reference interval limits emphasizes the need for the establishment of allergen specific ranges for IgG. These newly established ranges should be a useful aid for clinicians in the interpretation of laboratory serum IgG results. © 2016 by the Association of Clinical Scientists, Inc.

  11. The immunizing effect and reactogenicity of two live attenuated mumps virus vaccines in Swedish schoolchildren.

    PubMed

    Christenson, B; Heller, L; Böttiger, M

    1983-10-01

    An evaluation of the seroconversion and booster effects after vaccination with two different mumps vaccines, the Urabe Am 9 strain and the Jeryl Lynn strain, was carried out in schoolchildren. Four hundred and fifty-four schoolchildren aged 11 to 12 years with no previous history of mumps or mumps vaccination were enrolled for the study. The antibody responses were measured by serum neutralization (SN) and haemolysis-in-gel (HIG) tests. Of the 454 subjects, 130 were found to be initially seronegative. Two lots of different strengths of each vaccine were used to evaluate the relationships. The Urabe Am 9 vaccine lots had infectivity titres of 100 000 and 19 000 TCID50 per dose and the Jeryl Lynn vaccine titres of 59 000 and 28 000 TCID50 per dose. Only slight differences in seroconversion rates were seen between the lots. The overall seroconversion rate, measured by SN, was 94% for the Urabe Am 9 vaccine and 91% for the Jeryl Lynn vaccine, whereas the geometric mean titre for virus-neutralizing antibody in seroconverting children was 7.4 with the Urabe Am 9 vaccine and 10.7 with the Jeryl Lynn vaccine. In children who were seropositive prior to vaccination, a marked rise in antibody titre was found 8 weeks after vaccine injection indicating a booster effect. The miscellaneous post-vaccination side-effects were mild and inconsequential.

  12. Age-specific reference values for serum FSH and estradiol levels throughout the reproductive period.

    PubMed

    Grisendi, Valentina; Spada, Elena; Argento, Cindy; Plebani, Maddalena; Milani, Silvano; Seracchioli, Renato; Volpe, Annibale; La Marca, Antonio

    2014-06-01

    High serum day 3 FSH levels are associated with poor ovarian reserve and reduced fertility, but the interpretation of FSH values according to age is still not univocal. The purpose of this study was to determine age-dependent reference values in women with regular menstrual cycles and FSH as a guide for specialists. The study was performed at the Department of Mother-Infant of a University-based tertiary care centre. One-hundred ninety-two healthy normal menstruating women were recruited for the study. All patients attended the department on menstrual cycle day 3 for a blood sample for FSH and estradiol determination. A linear relationship between FSH or estradiol serum levels and age was observed. The FSH level increased by 0.11 IU for every year of age (1 IU for every 9 years of age). The values of FSH and estradiol corresponding to the 5th, 25th, 50th, 75th, 95th centiles for any specific age have been calculated. Serum FSH levels need to be interpreted according to age-dependent reference values. Serum FSH levels on 95th centile for any age may represent a warning sign for reduced ovarian reserve.

  13. Serum antioxidant capacity and peroxide level of seven healthy subjects after consumption of different foods.

    PubMed

    Laus, Maura N; Soccio, Mario; Alfarano, Michela; Pasqualone, Antonella; Lenucci, Marcello S; Di Miceli, Giuseppe; Pastore, Donato

    2016-12-01

    This article reports experimental data related to the research article entitled "Different effectiveness of two pastas supplemented with either lipophilic or hydrophilic/phenolic antioxidants in affecting serum as evaluated by the novel Antioxidant/Oxidant Balance approach" (M.N. Laus, M. Soccio, M. Alfarano, A. Pasqualone, M.S. Lenucci, G. Di Miceli, D. Pastore, 2016) [1]. Antioxidant status of blood serum of seven healthy subjects was evaluated during four hours after consumption of two functional pastas, supplemented with either bran oleoresin or bran water extract obtained from durum wheat. For comparison, the effect of a non-supplemented reference pasta was also evaluated, as well as the effects of glucose, of the wheat grain dietary supplement Lisosan G, and of the reference pasta consumed together with Lisosan G. Serum antioxidant status was evaluated by measuring both the serum antioxidant capacity, using LOX-FL, ORAC and TEAC methods, and the serum oxidant status, assessed as peroxide level.

  14. Goitrous hypothyroidism associated with treatment with trimethoprim-sulfamethoxazole in a young dog.

    PubMed

    Seelig, Davis M; Whittemore, Jacqueline C; Lappin, Michael R; Myers, Alan M; Avery, Paul R

    2008-04-15

    A 16-week-old female Boxer that had been treated for 5 weeks with trimethoprim-sulfamethoxazole and chloramphenicol because of aspiration pneumonia was evaluated for bilaterally symmetric masses in the subcutaneous tissues of the ventral neck, in the region of the larynx. Fine-needle aspirates were obtained from the neck masses; cytologic examination revealed well-differentiated thyroid epithelial tissue. A blood sample was collected for serum biochemical and thyroid function analyses. Mild hyperphosphatemia, severe hypercholesterolemia, mild hyperkalemia, and a mild increase in creatine kinase activity were identified. Serum concentration of total thyroxine was less than the lower reference limit, and that of thyroid-stimulating hormone was greater than the upper reference limit. Findings were consistent with a diagnosis of clinical hypothyroidism in a skeletally immature dog. Treatment with trimethoprim-sulfamethoxazole was discontinued. The dog was reevaluated 3 weeks later, at which time the neck masses were markedly decreased in size. Serum concentrations of cholesterol and potassium were lower; serum concentrations of total thyroxine and thyroid-stimulating hormone were near or within respective reference ranges. Age-appropriate increases in serum phosphorus concentration and serum alkaline phosphatase activity were also detected. To the authors' knowledge, this is the first report of antimicrobial-induced goiter in a dog. Cytologic examination of fine-needle aspirates and interpretation of data from serum biochemical and thyroid function analyses were needed to obtain a definitive diagnosis. Practitioners should include goiter among the differential diagnoses for ventral neck swellings in young dogs receiving potentiated sulfonamide antimicrobials.

  15. Serum Biochemical Phenotypes in the Domestic Dog

    PubMed Central

    Chang, Yu-Mei; Hadox, Erin; Szladovits, Balazs; Garden, Oliver A.

    2016-01-01

    The serum or plasma biochemical profile is essential in the diagnosis and monitoring of systemic disease in veterinary medicine, but current reference intervals typically take no account of breed-specific differences. Breed-specific hematological phenotypes have been documented in the domestic dog, but little has been published on serum biochemical phenotypes in this species. Serum biochemical profiles of dogs in which all measurements fell within the existing reference intervals were retrieved from a large veterinary database. Serum biochemical profiles from 3045 dogs were retrieved, of which 1495 had an accompanying normal glucose concentration. Sixty pure breeds plus a mixed breed control group were represented by at least 10 individuals. All analytes, except for sodium, chloride and glucose, showed variation with age. Total protein, globulin, potassium, chloride, creatinine, cholesterol, total bilirubin, ALT, CK, amylase, and lipase varied between sexes. Neutering status significantly impacted all analytes except albumin, sodium, calcium, urea, and glucose. Principal component analysis of serum biochemical data revealed 36 pure breeds with distinctive phenotypes. Furthermore, comparative analysis identified 23 breeds with significant differences from the mixed breed group in all biochemical analytes except urea and glucose. Eighteen breeds were identified by both principal component and comparative analysis. Tentative reference intervals were generated for breeds with a distinctive phenotype identified by comparative analysis and represented by at least 120 individuals. This is the first large-scale analysis of breed-specific serum biochemical phenotypes in the domestic dog and highlights potential genetic components of biochemical traits in this species. PMID:26919479

  16. Analysis of serum angiotensin-converting enzyme.

    PubMed

    Muller, B R

    2002-09-01

    Serum angiotensin-converting enzyme (SACE) levels are influenced by genetic polymorphism. Interpretation of serum levels with the appropriate genotypic reference range improves the diagnostic sensitivity of the assay for sarcoidosis. SACE assays are performed by a large number of routine clinical laboratories. However, there is no external quality assessment (EQA) for SACE other than an informal regional scheme. This showed analytical performance of SACE assays to be poor, with a diversity of reference ranges, leading to widely disparate clinical classification of EQA samples. Genetic polymorphism combined with poor analytical performance suggest that perhaps SACE assays should revert to being the province of specialized laboratories.

  17. Evaluation of p,p'-DDT as a reference toxicant in bioassays

    USGS Publications Warehouse

    Marking, Leif L.

    1966-01-01

    p,p'-DDT was tested as a reference standard toxicant against 19 species of freshwater fish, including 39 lots from 10 sources. In particular, the rapidity, nonselectivity, and consistency of its toxicity to fish were evaluated in 96-hour static bioassays. The chemical was rapidly and consistently toxic to lake trout, carp, green sunfish, bluegill, and yellow perch. It lacked either rapid or consistent toxicity to rainbow trout, brook trout, goldfish, fathead minnows, and longear sunfish in 96-hour tests. Thus, p,p'-DDT is of limited usefulness as a reference standard toxicant in large bioassays with many species of fish.

  18. Reference genes for measuring mRNA expression.

    PubMed

    Dundas, Jitesh; Ling, Maurice

    2012-12-01

    The aim of this review is to find answers to some of the questions surrounding reference genes and their reliability for quantitative experiments. Reference genes are assumed to be at a constant expression level, over a range of conditions such as temperature. These genes, such as GADPH and beta-actin, are used extensively for gene expression studies using techniques like quantitative PCR. There have been several studies carried out on identifying reference genes. However, a lot of evidence indicates issues to the general suitability of these genes. Recent studies had shown that different factors, including the environment and methods, play an important role in changing the expression levels of the reference genes. Thus, we conclude that there is no reference gene that can deemed suitable for all the experimental conditions. In addition, we believe that every experiment will require the scientific evaluation and selection of the best candidate gene for use as a reference gene to obtain reliable scientific results.

  19. Fundamental Importance of Reference Glucose Analyzer Accuracy for Evaluating the Performance of Blood Glucose Monitoring Systems (BGMSs)

    PubMed Central

    Bailey, Timothy S.; Klaff, Leslie J.; Wallace, Jane F.; Greene, Carmine; Pardo, Scott; Harrison, Bern; Simmons, David A.

    2016-01-01

    Background: As blood glucose monitoring system (BGMS) accuracy is based on comparison of BGMS and laboratory reference glucose analyzer results, reference instrument accuracy is important to discriminate small differences between BGMS and reference glucose analyzer results. Here, we demonstrate the important role of reference glucose analyzer accuracy in BGMS accuracy evaluations. Methods: Two clinical studies assessed the performance of a new BGMS, using different reference instrument procedures. BGMS and YSI analyzer results were compared for fingertip blood that was obtained by untrained subjects’ self-testing and study staff testing, respectively. YSI analyzer accuracy was monitored using traceable serum controls. Results: In study 1 (N = 136), 94.1% of BGMS results were within International Organization for Standardization (ISO) 15197:2013 accuracy criteria; YSI analyzer serum control results showed a negative bias (−0.64% to −2.48%) at the first site and a positive bias (3.36% to 6.91%) at the other site. In study 2 (N = 329), 97.8% of BGMS results were within accuracy criteria; serum controls showed minimal bias (<0.92%) at both sites. Conclusions: These findings suggest that the ability to demonstrate that a BGMS meets accuracy guidelines is influenced by reference instrument accuracy. PMID:26902794

  20. Human territoriality: an examination of a construct

    Treesearch

    Thomas D. Wickham; Harry C. Zinn

    2001-01-01

    Human territory research has generally been focused in a variety of settings including urban neighborhoods, libraries, mall parking lots, and areas around phones in public places. It refers to an intertwined system of emotions, beliefs, and behaviors that are place specific, socially and culturally influenced, and are linked to person-place transactions dealing with...

  1. Tuning the Blend

    ERIC Educational Resources Information Center

    Schaffhauser, Dian

    2012-01-01

    "Tuning the blend" is a phrase that educators hear a lot these days. It refers to finding the correct balance of online activities and face-to-face instruction in hybrid--or blended--courses. Finding a mix that meets the needs of both faculty and students requires experimentation, experience, and constant tweaking. And, as with coffee, the same…

  2. Case study: dairies utilizing ultra-high stock density grazing in the northeast

    USDA-ARS?s Scientific Manuscript database

    Ultra-high stock density (UHSD) grazing (also loosely referred to as ‘mob grazing’) has attracted a lot of attention and press in the forage industry. Numerous anecdotal articles can be found in trade magazines that promote the perceived benefits of UHSD grazing. However, there is little credible re...

  3. Formalin-inactivated Venezuelan Equine Encephalomyelitis (Trinidad Strain) Vaccine Produced in Rolling-Bottle Cultures of Chicken Embryo Cells

    PubMed Central

    Cole, Francis E.; May, Stephen W.; Robinson, David M.

    1973-01-01

    Formalin-inactivated Venezuelan equine encephalomyelitis vaccine was prepared from virus grown in rolling-bottle cultures of chicken embryo cells. Trinidad strain virus was propagated in these cultures with a maintenance medium consisting of serum-free medium 199 containing 0.25% human serum albumin (USP) and antibiotics. Manipulation of multiplicity of inoculum (0.06 to 0.00006) and maintenance medium volume (100 to 300 ml) resulted in high-titered virus yields and only moderate cell destruction when fluids from infected cultures were harvested at 18 to 24 hr. The virus was inactivated at 37 C by 0.05% Formalin within 8 to 10 hr and with 0.1% Formalin within 6 to 8 hr. Single dose, antigen extinction tests in mice performed with 30 small-scale vaccine lots showed excellent potency at either Formalin concentration with inactivation periods ranging from 24 to 96 hr. PMID:4694345

  4. Samsung Salmonella Detection Kit. AOAC Performance Tested Method(SM) 021203.

    PubMed

    Li, Jun; Cheung, Win Den; Opdyke, Jason; Harvey, John; Chong, Songchun; Moon, Cheol Gon

    2012-01-01

    Salmonella, one of the most common causes of foodborne illness, is a significant public health concern worldwide. There is a need in the food industry for methods that are simple, rapid, and sensitive for the detection of foodborne pathogens. In this study, the Samsung Salmonella Detection Kit, a real-time PCR assay for the detection of Salmonella, was evaluated according to the current AOAC guidelines. The validation consisted of lot-to-lot consistency, stability, robustness, and inclusivity/exclusivity studies, as well as a method comparison of 10 different food matrixes. In the validation, the Samsung Salmonella Detection Kit was used in conjunction with the Applied Biosystems StepOnePlus PCR system and the Samsung Food Testing Software for the detection of Salmonella species. The performance of the assays was compared to the U.S. Department of Agriculture/Food Safety and Inspection Service-Microbiology Laboratory Guidebook (USDA/FSIS-MLG) 4.05: Isolation and Identification of Salmonella from Meat, Poultry, Pasteurized Egg, and Catfish and the and U.S. Food and Drug Administration/Bacteriological Analytical Manual (FDA/BAM) Chapter 5 Salmonella reference methods. The validation was conducted using an unpaired study design for detection of Salmonella spp. in raw ground beef, raw pork, raw ground pork, raw chicken wings, raw salmon, alfalfa sprouts, pasteurized orange juice, peanut butter, pasteurized whole milk, and shell eggs. The Samsung Salmonella Detection Kit demonstrated lot-to-lot consistency among three independent lots as well as ruggedness with minor modifications to changes in enrichment incubation time, enrichment incubation temperature, and DNA sample volume for PCR reaction. Stability was observed for 13 months at -20 degrees C and 3 months at 5 degrees C. For the inclusivity/exclusivity study, the Samsung Salmonella Detection Kit correctly identified 147 Salmonella species isolates out of 147 isolates tested from each of three different enrichment broths (a total of 441 isolates detected), and correctly excluded all 31 nontarget strains analyzed. For the method comparison, statistical analysis was conducted according to the Mantel-Haenszel Chi-square formula for unpaired test portions, and there was no significant difference in the number of positive samples detected between the Samsung Salmonella Detection Kit and the USDA/FSIS-MLG and FDA/BAM reference methods for all 10 food matrixes.

  5. Assessment of criteria used by veterinary practitioners to diagnose hypothyroidism in sighthounds and investigation of serum thyroid hormone concentrations in healthy Salukis.

    PubMed

    Shiel, Robert E; Sist, MaryDee; Nachreiner, Raymond F; Ehrlich, Claire P; Mooney, Carmel T

    2010-02-01

    To assess use of serum thyroid hormone concentrations by veterinarians to diagnose hypothyroidism in sighthounds and to evaluate serum thyroid hormone concentrations in healthy Salukis. Retrospective case series and cross-sectional study. 398 sighthounds of various breeds with a diagnosis of hypothyroidism and 283 healthy Salukis. Pretreatment thyroid hormone assay results from sighthounds subsequently classified as hypothyroid by practitioners were retrieved from a laboratory database. In healthy Salukis, serum concentrations of total thyroxine (T(4)), free T(4), total triiodothyronine (T(3)), free T(3), and thyroid-stimulating hormone (TSH) and antibodies against thyroglobulin and thyroid hormones were assayed. Records indicated hypothyroidism had been diagnosed in 303 (76.1%) sight-hounds on the basis of low serum thyroid hormone concentrations alone and in 30 (7.5%) others despite all thyroid hormone indices being within reference limits. Only 65 (16.3%) dogs had a high TSH concentration or positive thyroglobulin autoantibody result to support the diagnosis. In healthy Salukis, median (reference limits) serum concentrations of total T(4), free T(4), total T(3), free T(3), and TSH were 13.0 nmol/L (2.8 to 40.0 nmol/L), 12.0 pmol/L (2.0 to 30.3 pmol/L), 1.0 nmol/L (0.4 to 2.1 nmol/L), 4.0 pmol/L (1.6 to 7.7 pmol/L), and 0.18 ng/mL (0 to 0.86 ng/mL), respectively. Diagnosis of hypothyroidism by practitioners was most often made without adequate supportive laboratory evidence. Thyroid hormone values in healthy Salukis differed markedly from standard reference limits for some, but not all, thyroid hormone indices. Breed-specific reference limits should be used when interpreting thyroid hormone profiles of sighthounds.

  6. How the reference values for serum parathyroid hormone concentration are (or should be) established?

    PubMed

    Souberbielle, J-C; Brazier, F; Piketty, M-L; Cormier, C; Minisola, S; Cavalier, E

    2017-03-01

    Well-validated reference values are necessary for a correct interpretation of a serum PTH concentration. Establishing PTH reference values needs recruiting a large reference population. Exclusion criteria for this population can be defined as any situation possibly inducing an increase or a decrease in PTH concentration. As recommended in the recent guidelines on the diagnosis and management of asymptomatic primary hyperparathyroidism, PTH reference values should be established in vitamin D-replete subjects with a normal renal function with possible stratification according to various factors such as age, gender, menopausal status, body mass index, and race. A consensus about analytical/pre-analytical aspects of PTH measurement is also needed with special emphasis on the nature of the sample (plasma or serum), the time and the fasting/non-fasting status of the blood sample. Our opinion is that blood sample for PTH measurement should be obtained in the morning after an overnight fast. Furthermore, despite longer stability of the PTH molecule in EDTA plasma, we prefer serum as it allows to measure calcium, a prerequisite for a correct interpretation of a PTH concentration, on the same sample. Once a consensus is reached, we believe an important international multicentre work should be performed to recruit a very extensive reference population of apparently healthy vitamin D-replete subjects with a normal renal function in order to establish the PTH normative data. Due to the huge inter-method variability in PTH measurement, a sufficient quantity of blood sample should be obtained to allow measurement with as many PTH kits as possible.

  7. The usefulness of rapid point-of-care creatinine testing for the prevention of contrast-induced nephropathy in the emergency department.

    PubMed

    You, Je Sung; Chung, Yong Eun; Park, Jong Woo; Lee, Woonhyoung; Lee, Hye-Jeong; Chung, Tae Nyoung; Chung, Sung Phil; Park, Incheol; Kim, Seungho

    2013-07-01

    Renal dysfunction is the most important factor to consider when predicting a patient's risk of developing contrast-induced nephropathy (CIN). Measurement of creatinine (Cr) via rapid point-of-care blood urea nitrogen/creatinine testing (POCT-BUN/Cr) to determine CIN risk could potentially reduce the time required to achieve an accurate diagnosis and to initiate and complete treatment in the emergency department (ED). The aim of our study was to compare the results of POCT-BUN/Cr and reference laboratory tests for BUN and serum Cr. A retrospective analysis of suspected stroke patients who presented between November 2009 and November 2010, and had BUN and Cr levels measured by POCT-BUN/Cr, and the reference laboratory tests performed with the blood sample which was transferred to the central laboratory by an air-shoot system. Two assays were conducted on the whole blood (POCT) and serum (reference) by trained technicians. The time interval from arrival at the ED to reporting of the results was assessed for both assays via a computerised physician order entry system. The mean standard deviation (SD) interval from arrival at the ED to reporting of the results was 11.4 (4.9) min for POCT-BUN/Cr and 46.8 (38.5) min for the serum reference laboratory tests (p<0.001). Intra-class correlation coefficient (ICC) analysis demonstrated a high level of agreement (the consistency agreement) between POCT and the serum reference tests for both BUN (ICC=0.914) and Cr (ICC=0.980). This study suggests that POCT-BUN/Cr results correlate well with those of serum reference tests in terms of BUN and Cr levels and, in turn, predicting CIN. POCT-BUN/Cr is easily performed with a rapid turnaround time, suggesting its use in the ED may have substantial clinical benefit.

  8. [Serum S100β protein reference values in a paediatric population].

    PubMed

    Arroyo Hernández, M; Rodríguez Suárez, J; Álvarez Menéndez, F

    2016-05-01

    S100β protein has been proposed as a potential biomarker for both chronic and acute neurological disorders. Reference values of this protein are well defined in adults but not in children, in whom serum levels appear to vary with age. Reference values for serum S100β in children from 0 to 14 years are presented. A prospective study was conducted on 257 healthy children, who were divided into three age groups (under 12 months, 12 to 24 months and over 24 months). The study included179 boys and 78 girls, with a mean age of 5.5 (3.75) years. The mean serum concentration of protein S100β was 0.156 (0.140-0.172) μg/l. In children under 12 months, serum S100β concentration was 0.350 (0.280-0.421) μg/l; 0.165 (0.139-0.190) μg/l in the group between 12 and 24 months and 0.121 (0.109-0.133) μg/l in children older than 24 months. An inverse relationship was observed between age and serum S100β, which declines as age increases. No differences were observed between sexes. The concentration of S100β remains stable after two years of age, being possible to establish a baseline of S100β for over two years. During the first two years of life, S100β serum concentration is higher, the lower the age of the child. No differences in serum S100β levels between sexes are observed. Copyright © 2015 Asociación Española de Pediatría. Published by Elsevier España, S.L.U. All rights reserved.

  9. Serum transferrin receptor status of healthy adult Arabs.

    PubMed

    Knox-Macaulay, Huxley; Gravell, David; Elender, Frances

    2007-01-01

    Several studies have provided reference ranges for the concentration of serum transferrin receptor (sTfR) in various white populations, but there is a dearth of relevant reference sTfR data in non-whites. The aim of this investigation was to establish sTfR reference ranges and mean values for a healthy non-white Arab population that could be used also for Arabs worldwide. sTfR and serum ferritin concentrations were estimated by immunoassays and blood counts were determined by conventional methods. Analysis of the data of 114 volunteer Arab blood donors (91 male, 23 female) revealed a higher mean sTfR concentration in males of 22.6+/-8.1 nmol/L (range 10.9-38.7 nmol/L) compared to that in females of 18.7+/-4.4 nmol/L (range 10.7-25.8 nmol/L, p=0.001). There was no significant correlation of sTfR concentration with age, serum ferritin level, or blood haemoglobin level, but a strong inverse correlation was demonstrated with mean cell volume and mean cell haemoglobin of red cells. Iron-replete volunteer subjects with alpha-thalassaemia trait appear to have relatively high mean sTfR concentration. We recommend the use of gender-dependent sTfR reference values for Arabs.

  10. Development of the Ion Exchange-Gravimetric Method for Sodium in Serum as a Definitive Method

    PubMed Central

    Moody, John R.; Vetter, Thomas W.

    1996-01-01

    An ion exchange-gravimetric method, previously developed as a National Committee for Clinical Laboratory Standards (NCCLS) reference method for the determination of sodium in human serum, has been re-evaluated and improved. Sources of analytical error in this method have been examined more critically and the overall uncertainties decreased. Additionally, greater accuracy and repeatability have been achieved by the application of this definitive method to a sodium chloride reference material. In this method sodium in serum is ion-exchanged, selectively eluted and converted to a weighable precipitate as Na2SO4. Traces of sodium eluting before or after the main fraction, and precipitate contaminants are determined instrumentally. Co-precipitating contaminants contribute less than 0.1 % while the analyte lost to other eluted ion-exchange fractions contributes less than 0.02 % to the total precipitate mass. With improvements, the relative expanded uncertainty (k = 2) of the method, as applied to serum, is 0.3 % to 0.4 % and is less than 0.1 % when applied to a sodium chloride reference material. PMID:27805122

  11. Occurrence of polycyclic aromatic hydrocarbons below coal-tar-sealed parking lots and effects on stream benthic macroinvertebrate communities

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Scoggins, M.; McClintock, N.L.; Gosselink, L.

    2007-12-15

    Parking-lot pavement sealants recently have been recognized as a major source of polycyclic aromatic hydrocarbons (PAHs) in urban stream sediments in Austin, Texas. Laboratory and field studies have shown that PAHs in sediments can be toxic to aquatic organisms and can degrade aquatic communities. After identifying increases in concentrations of PAHs in sediments below seal-coated parking lots, we investigated whether the increases had significant effects on stream biota in 5 Austin streams. We sampled sediment chemistry and biological communities above and below the point at which stormwater runoff from the parking lots discharged into the streams, thus providing 5 upstreammore » reference sites and 5 downstream treatment sites. Differences between upstream and downstream concentrations of total PAH ranged from 3.9 to 32 mg/kg. Analysis of the species occurrence data from pool and riffle habitats indicated a significant decrease in community health at the downstream sites, including decreases in richness, intolerant taxa, Diptera taxa, and density. In pool sediments, Chironomidae density was negatively correlated with PAH concentrations, whereas Oligochaeta density responded positively to PAH concentrations. In general, pool taxa responded more strongly than riffle taxa to PAHs, but riffle taxa responded more broadly than pool taxa. Increases in PAH sediment-toxicity units between upstream and downstream sites explained decreases in taxon richness and density in pools between upstream and downstream sites.« less

  12. Clinical biochemistry of pregnant and nursing mares.

    PubMed

    Harvey, John W; Pate, Melanie G; Kivipelto, Jan; Asquith, Richard L

    2005-09-01

    Pregnancy and lactation result in increased metabolic demands. Although homeostatic mechanisms function to keep substances in blood at relatively constant levels, some changes in the concentrations of routine clinical chemistry analytes are likely to occur. The purpose of this study was to determine what physiological changes occur in serum clinical biochemistry analytes in pregnant and nursing mares, and to determine whether the changes were substantial enough to warrant separate reference intervals for pregnant or lactating horses. Forty-two Quarter Horse, Thoroughbred, Saddlebred, Standardbred and Morgan mares were entered into the study while pregnant. They were bled once each month through birth. Studies were continued on 20 mares until their foals were weaned. Test results were tabulated by time before or after birth. Serum biochemistry values were determined by standard methods using automated analyzers. Test results were analyzed using the Kruskal-Wallis 1-way ANOVA on ranks. If a significant difference was found (P<.05), Dunn's multiple comparison procedure was performed on all pairs. Results from pregnant and nursing mares also were compared with a reference group of 19 open, nonlactating mares. Serum triglyceride, potassium, creatinine, and total bilirubin concentrations were lower during lactation than during pregnancy. Serum calcium concentration also was slightly decreased at 2 time points during lactation. Triglyceride concentration was highest during midgestation, while bilirubin and creatinine values increased, and potassium and calcium remained constant during pregnancy. Serum urea concentration also remained constant during pregnancy but increased during lactation. Serum phosphate concentration was lowest during midgestation and highest during lactation. Total CO2 values were highest, and anion gaps were lowest, during midgestation. No significant differences were found in serum albumin, globulin, albumin:globulin ratio, total protein, or glucose values. When compared with the reference group of open mares, serum triglyceride, potassium, bilirubin, and total CO2 concentrations were lower, and anion gap was higher in horses that were nursing. Although most biochemical values remained relatively constant, significant differences were observed during pregnancy and lactation. Changes in the concentrations of triglycerides, potassium, bilirubin, total CO2, and anion gap during lactation were substantial enough to warrant separate reference intervals for lactating horses.

  13. Issues and Challenges in Cataloguing Arabic Books in Malaysia Academic Libraries

    ERIC Educational Resources Information Center

    Ismail, Mohd Ikhwan; Roni, Nurul Azurah Md.

    2011-01-01

    Education in Library and Information Science is a requirement to become a librarian. There are a lot of syllabi and subjects to concentrate on such as cataloguing and classification, information retrieval, knowledge management, and reference. The library as a centre of information has been developing year by year with various types of collections…

  14. Designing a Personalized Guide Recommendation System to Mitigate Information Overload in Museum Learning

    ERIC Educational Resources Information Center

    Huang, Yong-Ming; Liu, Chien-Hung; Lee, Chun-Yi; Huang, Yueh-Min

    2012-01-01

    Museum learning has received a lot of attention in recent years. Museum learning refers to people's use of museums to acquire knowledge. However, a problem with information overload has caused in engaging in such learning. Information overload signifies that users encounter a mass of information and need to determine whether certain information…

  15. Serum fructosamine concentrations in 59 dogs naturally Infected with Angiostrongylus vasorum.

    PubMed

    Willesen, J L; Jensen, A L; Kristensen, A T; Kjelgaard-Hansen, M; Jessen, R; Koch, J

    2006-06-01

    Retrospectively, 89 cases of dogs infected with Angiostrongylus vasorum were examined. Fifty-nine of these 89 dogs fulfilled the criteria of not being dually infected with Crenosoma vulpis as well as having a full biochemistry profile including serum fructosamine available. The mean serum fructosamine value of the 59 dogs was 236 micromol/l (reference value 258-348 micromol/l) and significantly lower than the serum fructosamine level of 314 micromol/l in a control group of 42 clinically healthy dogs. Eleven dogs were available for follow up after successful treatment of angiostrongylosis. In this group, the serum fructosamine value rose from a mean of 244 micromol/l to a mean of 320 micromol/l following treatment. Serum glucose, albumin and protein were all within the respective reference ranges at all sampling points. The results indicate that serum fructosamine could be affected by infection with A. vasorum. Furthermore, this change cannot be explained by measurable changes in the level of glucose, albumin or protein. The clinical impact of this study is that a low fructosamine value may indicate infection with A. vasorum thereby suggesting a Baermann test to be performed.

  16. Baseline Assessment of 25-Hydroxyvitamin D Reference Material and Proficiency Testing/External Quality Assurance Material Commutability: A Vitamin D Standardization Program Study.

    PubMed

    Phinney, Karen W; Sempos, Christopher T; Tai, Susan S-C; Camara, Johanna E; Wise, Stephen A; Eckfeldt, John H; Hoofnagle, Andrew N; Carter, Graham D; Jones, Julia; Myers, Gary L; Durazo-Arvizu, Ramon; Miller, W Greg; Bachmann, Lorin M; Young, Ian S; Pettit, Juanita; Caldwell, Grahame; Liu, Andrew; Brooks, Stephen P J; Sarafin, Kurtis; Thamm, Michael; Mensink, Gert B M; Busch, Markus; Rabenberg, Martina; Cashman, Kevin D; Kiely, Mairead; Galvin, Karen; Zhang, Joy Y; Kinsella, Michael; Oh, Kyungwon; Lee, Sun-Wha; Jung, Chae L; Cox, Lorna; Goldberg, Gail; Guberg, Kate; Meadows, Sarah; Prentice, Ann; Tian, Lu; Brannon, Patsy M; Lucas, Robyn M; Crump, Peter M; Cavalier, Etienne; Merkel, Joyce; Betz, Joseph M

    2017-09-01

    The Vitamin D Standardization Program (VDSP) coordinated a study in 2012 to assess the commutability of reference materials and proficiency testing/external quality assurance materials for total 25-hydroxyvitamin D [25(OH)D] in human serum, the primary indicator of vitamin D status. A set of 50 single-donor serum samples as well as 17 reference and proficiency testing/external quality assessment materials were analyzed by participating laboratories that used either immunoassay or LC-MS methods for total 25(OH)D. The commutability test materials included National Institute of Standards and Technology Standard Reference Material 972a Vitamin D Metabolites in Human Serum as well as materials from the College of American Pathologists and the Vitamin D External Quality Assessment Scheme. Study protocols and data analysis procedures were in accordance with Clinical and Laboratory Standards Institute guidelines. The majority of the test materials were found to be commutable with the methods used in this commutability study. These results provide guidance for laboratories needing to choose appropriate reference materials and select proficiency or external quality assessment programs and will serve as a foundation for additional VDSP studies.

  17. Glycerophosphate is interchangeable with inorganic phosphate in terms of safety and serum pharmacokinetics.

    PubMed

    Topp, Heinrich; Hochfeld, Olena; Bark, Staffan; Grossmann, Matthias; Joukhadar, Christian; Westphal, Martin; Straatsma, Harald; Rothenburger, Markus

    2011-01-01

    The primary aim of the present investigation was to determine and compare the pharmacokinetic (PK) profiles of inorganic phosphate in serum and urine after intravenous administration of sodium glycerophosphate and inorganic sodium phosphate. Additionally, study product safety profiles were evaluated. In total, 27 healthy, white volunteers (17 male/10 female) were enrolled in this double-blinded, randomized, 2-sequence, crossover study and were assigned to receive an organic test drug (sodium glycerophosphate) and an inorganic reference preparation (sodium phosphate) on 2 occasions. Validated analytical methods were used, and concentrations of total inorganic phosphate in serum and urine were determined over 24 h following a single 4-hour continuous intravenous infusion of test and reference drugs at a dose of 80 mmol. Study days were separated by washout periods of 7 days. An analysis of variance, based on population means and 90% confidence intervals (CIs), was used for testing bioequivalence (BE; range 0.8-1.25) between investigational products. The geometric means of the ratio of the point estimates and corresponding 90% CIs for the area under the concentration-versus-time curve of inorganic serum phosphate from 0 to 24 h (AUC(0-24)), the phosphate's maximum concentration in serum (C(max)) and the total amount of inorganic phosphate excreted in urine over 24 h corrected for individual baseline values (Ae(0-24 bc)) were estimated. The test/reference ratios for inorganic phosphate were 1.04 (CI 1.00-1.07), 0.85 (CI 0.84-0.87) and 0.84 (CI 0.77-0.92) for AUC(0-24), C(max) in serum and Ae(0-24 bc) in urine, respectively. Hence, standard BE criteria were met for AUC(0-24) and C(max) in serum, while Ae(0-24 bc) marginally failed to demonstrate BE. After drug administration, a total of 15 subjects reported the occurrence of at least 1 treatment emergent adverse event (AE). All AEs were classified as mild to moderate in severity, and the two treatment groups were equally affected. No serious AEs occurred. The serum PK profiles of inorganic phosphate were almost superimposable following intravenous administration of equimolar doses of test and reference drugs. Thus, we conclude that the two study drugs are essentially similar in terms of serum PK profiles, safety and tolerability. Copyright © 2011 S. Karger AG, Basel.

  18. Analysis of serum and cerebrospinal fluid in clinically normal adult miniature donkeys.

    PubMed

    Mozaffari, A A; Samadieh, H

    2013-09-01

    To establish reference intervals for serum and cerebrospinal fluid (CSF) parameters in clinically healthy adult miniature donkeys. Experiments were conducted on 10 female and 10 male clinically normal adult miniature donkeys, randomly selected from five herds. Lumbosacral CSF collection was performed with the sedated donkey in the standing position. Cell analysis was performed immediately after the samples were collected. Blood samples were obtained from the jugular vein immediately after CSF sample collection. Sodium, potassium, glucose, urea nitrogen, total protein, calcium, chloride, phosphorous and magnesium concentrations were measured in CSF and serum samples. A paired t-test was used to compare mean values between female and male donkeys. The CSF was uniformly clear, colourless and free from flocculent material, with a specific gravity of 1.002. The range of total nucleated cell counts was 2-4 cells/μL. The differential white cell count comprised only small lymphocytes. No erythrocytes or polymorphonuclear cells were observed on cytological examination. Reference values were obtained for biochemical analysis of serum and CSF. Gender had no effect on any variables measured in serum or CSF (p>0.05). CSF analysis can provide important information in addition to that gained by clinical examination. CSF analysis has not previously been performed in miniature donkeys; this is the first report on the subject. In the present study, reference intervals for total nucleated cell count, total protein, glucose, urea nitrogen, sodium, potassium, chloride, calcium, phosphorous and magnesium concentrations of serum and CSF were determined for male and female miniature donkeys.

  19. Serum reference value of two potential doping candidates-myostatin and insulin-like growth factor-I in the healthy young male.

    PubMed

    Han, Der-Sheng; Huang, Chi-Huang; Chen, Ssu-Yuan; Yang, Wei-Shiung

    2017-01-01

    Myostatin negatively regulates muscle growth, and its inhibition by suitable proteins can increase muscle bulk and exercise performance. However, the reference values of serum myostatin in athletes performing strength training are still lacking. A cross-sectional study recruiting28 male collegiate athletes performing strength training and 29 age-matched normal controls was conducted. The serum concentration of myostatin and insulin-like growth factor 1 (IGF-1), grip strength, and body composition were the main outcome measures. We used regression models to analyze the correlation between serum markers and the physiological parameters. The athlete group had greater height, weight, body mass index (BMI), fat mass percentage, fat-free mass, muscle mass, waist girth, grip strength, and estimated daily energy expenditure. The IGF-1 concentration was higher in the athlete group (324 ± 80 vs. 263 ± 134 ng/ml), but the myostatin levels did not differ (12.1 ± 3.7 vs. 12.4 ± 3.5 ng/ml). The reference value for IGF-1 among the healthy young males was 293 ± 114 ng/ml, correlated with age and height; the value for myostatin was 12.3 ± 3.6 ng/ml, correlated negatively with BMI, fat mass percentage, and waist girth after adjustment for age. Myostatin level is negatively related to fat percentage, and serum IGF-1 is positively related to height. The reference values could provide a basis for future doping-related study.

  20. CSAHi study-2: Validation of multi-electrode array systems (MEA60/2100) for prediction of drug-induced proarrhythmia using human iPS cell-derived cardiomyocytes: Assessment of reference compounds and comparison with non-clinical studies and clinical information.

    PubMed

    Nozaki, Yumiko; Honda, Yayoi; Watanabe, Hitoshi; Saiki, Shota; Koyabu, Kiyotaka; Itoh, Tetsuji; Nagasawa, Chiho; Nakamori, Chiaki; Nakayama, Chiaki; Iwasaki, Hiroshi; Suzuki, Shinobu; Tanaka, Kohji; Takahashi, Etsushi; Miyamoto, Kaori; Morimura, Kaoru; Yamanishi, Atsuhiro; Endo, Hiroko; Shinozaki, Junko; Nogawa, Hisashi; Shinozawa, Tadahiro; Saito, Fumiyo; Kunimatsu, Takeshi

    2017-08-01

    With the aim of reconsidering ICH S7B and E14 guidelines, a new in vitro assay system has been subjected to worldwide validation to establish a better prediction platform for potential drug-induced QT prolongation and the consequent TdP in clinical practice. In Japan, CSAHi HEART team has been working on hiPS-CMs in the MEA (hiPS-CMs/MEA) under a standardized protocol and found no inter-facility or lot-to-lot variability for proarrhythmic risk assessment of 7 reference compounds. In this study, we evaluated the responses of hiPS-CMs/MEA to another 31 reference compounds associated with cardiac toxicities, and gene expression to further clarify the electrophysiological characteristics over the course of culture period. The hiPS-CMs/MEA assay accurately predicted reference compounds potential for arrhythmogenesis, and yielded results that showed better correlation with target concentrations of QTc prolongation or TdP in clinical setting than other current in vitro and in vivo assays. Gene expression analyses revealed consistent profiles in all samples within and among the testing facilities. This report would provide CiPA with informative guidance on the use of the hiPS-CMs/MEA assay, and promote the establishment of a new paradigm, beyond conventional in vitro and in vivo assays for cardiac safety assessment of new drugs. Copyright © 2017 Elsevier Inc. All rights reserved.

  1. Certification of NIST Room Temperature Low-Energy and High-Energy Charpy Verification Specimens

    PubMed Central

    Lucon, Enrico; McCowan, Chris N.; Santoyo, Ray L.

    2015-01-01

    The possibility for NIST to certify Charpy reference specimens for testing at room temperature (21 °C ± 1 °C) instead of −40 °C was investigated by performing 130 room-temperature tests from five low-energy and four high-energy lots of steel on the three master Charpy machines located in Boulder, CO. The statistical analyses performed show that in most cases the variability of results (i.e., the experimental scatter) is reduced when testing at room temperature. For eight out of the nine lots considered, the observed variability was lower at 21 °C than at −40 °C. The results of this study will allow NIST to satisfy requests for room-temperature Charpy verification specimens that have been received from customers for several years: testing at 21 °C removes from the verification process the operator’s skill in transferring the specimen in a timely fashion from the cooling bath to the impact position, and puts the focus back on the machine performance. For NIST, it also reduces the time and cost for certifying new verification lots. For one of the low-energy lots tested with a C-shaped hammer, we experienced two specimens jamming, which yielded unusually high values of absorbed energy. For both specimens, the signs of jamming were clearly visible. For all the low-energy lots investigated, jamming is slightly more likely to occur at 21 °C than at −40 °C, since at room temperature low-energy samples tend to remain in the test area after impact rather than exiting in the opposite direction of the pendulum swing. In the evaluation of a verification set, any jammed specimen should be removed from the analyses. PMID:26958453

  2. Certification of NIST Room Temperature Low-Energy and High-Energy Charpy Verification Specimens.

    PubMed

    Lucon, Enrico; McCowan, Chris N; Santoyo, Ray L

    2015-01-01

    The possibility for NIST to certify Charpy reference specimens for testing at room temperature (21 °C ± 1 °C) instead of -40 °C was investigated by performing 130 room-temperature tests from five low-energy and four high-energy lots of steel on the three master Charpy machines located in Boulder, CO. The statistical analyses performed show that in most cases the variability of results (i.e., the experimental scatter) is reduced when testing at room temperature. For eight out of the nine lots considered, the observed variability was lower at 21 °C than at -40 °C. The results of this study will allow NIST to satisfy requests for room-temperature Charpy verification specimens that have been received from customers for several years: testing at 21 °C removes from the verification process the operator's skill in transferring the specimen in a timely fashion from the cooling bath to the impact position, and puts the focus back on the machine performance. For NIST, it also reduces the time and cost for certifying new verification lots. For one of the low-energy lots tested with a C-shaped hammer, we experienced two specimens jamming, which yielded unusually high values of absorbed energy. For both specimens, the signs of jamming were clearly visible. For all the low-energy lots investigated, jamming is slightly more likely to occur at 21 °C than at -40 °C, since at room temperature low-energy samples tend to remain in the test area after impact rather than exiting in the opposite direction of the pendulum swing. In the evaluation of a verification set, any jammed specimen should be removed from the analyses.

  3. Participatory Action Research: An Overview--What Makes It Tick?

    ERIC Educational Resources Information Center

    Gaffney, Michael

    2008-01-01

    In this article I outline different elements of action research in an attempt to describe and define participatory action research (PAR). There is a lot more material available to readers these days, some of which I will refer you to in this article. I see my role here is to summarise enough of this material to help support your reading of the…

  4. 78 FR 50126 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of Filing of a Proposed Rule Change To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-16

    .... However, as the Commission has made clear with respect to BX's affiliate, the NASDAQ Stock Exchange LLC...: Manipulation patterns that monitor solely BX activity, including patterns that monitor activity that might... the opposite side of the BX market at an improved price (often referred to as ``odd lot manipulation...

  5. Reach for Reference. Nostalgia for Teachers, History for Students: Bowling, Beatniks, and Bell-Bottoms

    ERIC Educational Resources Information Center

    Safford, Barbara Ripp

    2005-01-01

    This article describes the U-X-L encyclopedia "Bowling, Beatniks, and Bell-Bottoms: Pop Culture of 20th Century America," a five-volume set, arranged chronologically with two decades in each volume. Each decade then is divided into topics, such as commerce (more exciting than it sounds with lots of inventions, consumer goods, and technology); film…

  6. 40 CFR Appendix 6 to Subpart A of... - Reverse Phase Extraction (RPE) Method for Detection of Oil Contamination in Non-Aqueous Drilling...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... rigorous statistical experimental design and interpretation (Reference 16.4). 14.0Pollution Prevention 14... fluids. 1.4This method has been designed to show positive contamination for 5% of representative crude....1Sample collection bottles/jars—New, pre-cleaned bottles/jars, lot-certified to be free of artifacts...

  7. 40 CFR Appendix 6 to Subpart A of... - Reverse Phase Extraction (RPE) Method for Detection of Oil Contamination in Non-Aqueous Drilling...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... rigorous statistical experimental design and interpretation (Reference 16.4). 14.0Pollution Prevention 14... fluids. 1.4This method has been designed to show positive contamination for 5% of representative crude....1Sample collection bottles/jars—New, pre-cleaned bottles/jars, lot-certified to be free of artifacts...

  8. 40 CFR Appendix 6 to Subpart A of... - Reverse Phase Extraction (RPE) Method for Detection of Oil Contamination in Non-Aqueous Drilling...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... rigorous statistical experimental design and interpretation (Reference 16.4). 14.0Pollution Prevention 14... fluids. 1.4This method has been designed to show positive contamination for 5% of representative crude....1Sample collection bottles/jars—New, pre-cleaned bottles/jars, lot-certified to be free of artifacts...

  9. 40 CFR Appendix 6 to Subpart A of... - Reverse Phase Extraction (RPE) Method for Detection of Oil Contamination in Non-Aqueous Drilling...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... rigorous statistical experimental design and interpretation (Reference 16.4). 14.0Pollution Prevention 14... oil contamination in drilling fluids. 1.4This method has been designed to show positive contamination....1Sample collection bottles/jars—New, pre-cleaned bottles/jars, lot-certified to be free of artifacts...

  10. Preparation and value assignment of standard reference material 968e fat-soluble vitamins, carotenoids, and cholesterol in human serum.

    PubMed

    Thomas, Jeanice B; Duewer, David L; Mugenya, Isaac O; Phinney, Karen W; Sander, Lane C; Sharpless, Katherine E; Sniegoski, Lorna T; Tai, Susan S; Welch, Michael J; Yen, James H

    2012-01-01

    Standard Reference Material 968e Fat-Soluble Vitamins, Carotenoids, and Cholesterol in Human Serum provides certified values for total retinol, γ- and α-tocopherol, total lutein, total zeaxanthin, total β-cryptoxanthin, total β-carotene, 25-hydroxyvitamin D(3), and cholesterol. Reference and information values are also reported for nine additional compounds including total α-cryptoxanthin, trans- and total lycopene, total α-carotene, trans-β-carotene, and coenzyme Q(10). The certified values for the fat-soluble vitamins and carotenoids in SRM 968e were based on the agreement of results from the means of two liquid chromatographic methods used at the National Institute of Standards and Technology (NIST) and from the median of results of an interlaboratory comparison exercise among institutions that participate in the NIST Micronutrients Measurement Quality Assurance Program. The assigned values for cholesterol and 25-hydroxyvitamin D(3) in the SRM are the means of results obtained using the NIST reference method based upon gas chromatography-isotope dilution mass spectrometry and liquid chromatography-isotope dilution tandem mass spectrometry, respectively. SRM 968e is currently one of two available health-related NIST reference materials with concentration values assigned for selected fat-soluble vitamins, carotenoids, and cholesterol in human serum matrix. This SRM is used extensively by laboratories worldwide primarily to validate methods for determining these analytes in human serum and plasma and for assigning values to in-house control materials. The value assignment of the analytes in this SRM will help support measurement accuracy and traceability for laboratories performing health-related measurements in the clinical and nutritional communities.

  11. Hypolipidemic Effect of Red Gram (Cajanus cajan L.) Prebiotic Oligosaccharides in Wistar NIN Rats.

    PubMed

    Shakappa, Devindra; Talari, Aruna; Rajkumar, Hemalatha; Shujauddin, Mohammed

    2017-08-24

    The hypolipidemic effect of red gram prebiotics of raffinose family oligosaccharides was studied in Wistar National Institute of Nutrition male rat strain. The study consisted of 36 rats randomly divided into three groups of 12 rats each. For 16 weeks, Group I was fed with the control diet; Group II was fed with a diet containing 3% standard raffinose as the reference group; Group III received the diet containing 3% red gram prebiotics. The results showed that the gain in body weight was low in the red gram prebiotics-supplemented group followed by the control group; highest increase of body weight was seen in the raffinose standard-fed group. Serum glucose levels of the red gram prebiotic-fed group decreased 14.92% compared to the control group and increased 2.07% compared to the reference group. The decrease in serum triglycerides (TG) levels of the red gram prebiotic-fed groups was 32.76% compared to the control group and 33.64% compared to the reference group. Decrease in the serum TC of the red gram-fed animals was 18.51% and 4.63% compared to the control group and the reference group, respectively. Increase in the level of serum high-density lipoprotein cholesterol (HDL-C) in the red gram-fed animals was 18.51% compared to the control group and 4.63% compared to the reference group. The present study can be a proof for the use of prebiotics as a preventive measure for overweight and obesity in humans, and legume prebiotics can be explored as a novel prebiotic product in the consumer market.

  12. The establishment of a WHO Reference Reagent for anti-malaria (Plasmodium falciparum) human serum.

    PubMed

    Bryan, Donna; Silva, Nilupa; Rigsby, Peter; Dougall, Thomas; Corran, Patrick; Bowyer, Paul W; Ho, Mei Mei

    2017-08-05

    At a World Health Organization (WHO) sponsored meeting it was concluded that there is an urgent need for a reference preparation that contains antibodies against malaria antigens in order to support serology studies and vaccine development. It was proposed that this reference would take the form of a lyophilized serum or plasma pool from a malaria-endemic area. In response, an immunoassay standard, comprising defibrinated human plasma has been prepared and evaluated in a collaborative study. A pool of human plasma from a malaria endemic region was collected from 140 single plasma donations selected for reactivity to Plasmodium falciparum apical membrane antigen-1 (AMA-1) and merozoite surface proteins (MSP-1 19 , MSP-1 42 , MSP-2 and MSP-3). This pool was defibrinated, filled and freeze dried into a single batch of ampoules to yield a stable source of naturally occurring antibodies to P. falciparum. The preparation was evaluated by an enzyme-linked immunosorbent assay (ELISA) in a collaborative study with sixteen participants from twelve different countries. This anti-malaria human serum preparation (NIBSC Code: 10/198) was adopted by the WHO Expert Committee on Biological Standardization (ECBS) in October 2014, as the first WHO reference reagent for anti-malaria (Plasmodium falciparum) human serum with an assigned arbitrary unitage of 100 units (U) per ampoule. Analysis of the reference reagent in a collaborative study has demonstrated the benefit of this preparation for the reduction in inter- and intra-laboratory variability in ELISA. Whilst locally sourced pools are regularly use for harmonization both within and between a few laboratories, the presence of a WHO-endorsed reference reagent should enable optimal harmonization of malaria serological assays either by direct use of the reference reagent or calibration of local standards against this WHO reference. The intended uses of this reference reagent, a multivalent preparation, are (1) to allow cross-comparisons of results of vaccine trials performed in different centres/with different products; (2) to facilitate standardization and harmonization of immunological assays used in epidemiology research; and (3) to allow optimization and validation of immunological assays used in malaria vaccine development.

  13. Age- and sex-specific reference values for fasting serum insulin levels and insulin resistance/sensitivity indices in healthy Iranian adults: Tehran Lipid and Glucose Study.

    PubMed

    Tohidi, Maryam; Ghasemi, Asghar; Hadaegh, Farzad; Derakhshan, Arash; Chary, Abdolreza; Azizi, Fereidoun

    2014-04-01

    Increased insulin concentration is a surrogate for insulin resistance and early assessment of fasting insulin may help in identifying those who are potentially at high risk of type 2 diabetes, hypertension, and cardiovascular disease. The aim of this study was to determine age- and sex-related reference values for serum insulin and insulin resistance/sensitivity indices in Iranian subjects. Serum insulin levels were measured by electrochemiluminescence immunoassay in 5786 participants of the Tehran Lipid and Glucose Study. After application of exclusion criteria, 309 non-obese healthy subjects (124 men and 185 women), aged 24-83 y, were included. The International Federation of Clinical Chemistry guidelines (non-parametric method) and the robust method were used for determining reference values. Overall 95% reference values for fasting insulin were 1.61-11.37, 2.34-11.98, and 2.11-12.49 μU/mL in men, women, and total population respectively. Mean fasting insulin concentration showed a decreasing trend with age in both genders (p for trend ≤0.001). Age, waist circumference, and systolic blood pressures were biological determinants of fasting insulin in both genders; in addition, insulin was modulated by triglycerides in men and fasting glucose in women. Reference intervals for HOMA1-IR, HOMA2-IR, and QUICKI were 0.63-2.68, 0.40-1.80, and 0.33-0.42, respectively. This study presents the first set of reference values for fasting serum insulin to be 2-12 μU/mL for both genders in a healthy sample of Iranian adults along with the reference values for insulin resistance/sensitivity indices. These values could be used for identifying subjects with insulin resistance in epidemiological and clinical research. Copyright © 2014 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  14. Evaluation of an anal sac adenocarcinoma tumor in a Spitz dog.

    PubMed

    Javanbakht, Javad; Tavassoli, Abbas; Sabbagh, Atefeh; Hassan, Mehdy Aghamohammmad; Samakkhah, Shohreh Alian; Shafiee, Radmehr; Lakzian, Ali; Ghalee, Vahideh Rahmani; Gharebagh, Sonia Shoja

    2013-01-01

    A 9-year-old emasculated male Spitz with tenesmus and constipation had a subcutaneous mass at the left ventral aspect of the anus with history of polyuria and polydipsia. A complete blood cell count, serum biochemistry panel, and urinalysis (cystocentesis sample) were evaluated. Abnormalities in the serum biochemistry panel included a mildly elevated serum cholesterol concentration (7.28 mmol/L; reference interval, 2.70-5.94 mmol/L), increased serum alkaline phosphatase activity (184 U/L; reference interval, 9-90 U/L), alanine transaminase (122 U/L; reference interval, 5-60 U/L) activity and aspartate aminotransferase (80 U/L; reference interval, 5-55 U/L) activity, severe increased total calcium concentration (16.3 mg/dL; reference interval, 8.2-12.4 mg/dL or 9.3-11.4 mg/dL), and decreased total calcium concentration (3.4 mg/dL, reference interval, 2.5-5.6mg/dL). Furthermore, testing revealed an increased intact parathyroid hormone concentration (38.6 pmol/L; reference interval, 3-17 pmol/L). On cytologic and histopathologic examinations, various types of cells were observed. Most of the cells were oval to polygonal and had elliptical or elongate nuclei and a moderate amount of pale to basophilic cytoplasm. The remaining cells had round to oval nuclei and pale to basophilic cytoplasm. Cells of both types were loosely adhered to each other and were arranged in rosette-like structures. Both neoplastic cell types had fine homogenous chromatin and either a small indistinct nucleolus or no visible nucleolus. Mild anisokaryosis and anisocytosis were observed. Histologically, the mass consists of glandular structures formed by cuboidal cells admixed with bundles of spindle cells. Based on location and histologic features, the final diagnosis was adenocarcinoma of the apocrine gland of the anal sac, which should be included as a cytologic differential diagnosis when spindle cells and typical epithelial cells are observed in masses in the region of the anal sac of dogs.

  15. Novel lipoprotein density profiling in healthy dogs of various breeds, healthy miniature schnauzers, and miniature schnauzers with hyperlipidemia

    PubMed Central

    2013-01-01

    Background Despite the importance of abnormalities in lipoprotein metabolism in clinical canine medicine, the fact that most previously used methods for lipoprotein profiling are rather laborious and time-consuming has been a major obstacle to the wide clinical application and use of lipoprotein profiling in this species. The aim of the present study was to assess the feasibility of a continuous lipoprotein density profile (CLPDP) generated within a bismuth sodium ethylenediaminetetraacetic acid (NaBiEDTA) density gradient to characterize and compare the lipoprotein profiles of healthy dogs of various breeds, healthy Miniature Schnauzers, and Miniature Schnauzers with primary hypertriacylglycerolemia. A total of 35 healthy dogs of various breeds with serum triacylglycerol (TAG) and cholesterol concentrations within their respective reference intervals were selected for use as a reference population. Thirty-one Miniature Schnauzers with serum TAG and cholesterol concentrations within their respective reference intervals and 31 Miniature Schnauzers with hypertriacylglyceridemia were also included in the study. Results The results suggest that CLPDP using NaBiEDTA provides unique diagnostic information in addition to measurements of serum TAG and cholesterol concentrations and that it is a useful screening method for dogs with suspected lipoprotein metabolism disorders. Using the detailed and continuous density distribution information provided by the CLPDP, important differences in lipoprotein profiles can be detected even among dogs that have serum TAG and cholesterol concentrations within the reference interval. Miniature Schnauzers with serum TAG and cholesterol concentrations within the reference interval had significantly different lipoprotein profiles than dogs of various other breeds. In addition, it was further established that specific lipoprotein fractions are associated with hypertriacylglyceridemia in Miniature Schnauzers. Conclusions The results of the present study suggest that density gradient ultracentrifugation using NaBiEDTA is a useful screening method for the study of lipoprotein profiles in dogs. Therefore, this method could potentially be used for diagnostic purposes for the separation of dogs suspected of having lipoprotein abnormalities from healthy dogs. PMID:23497598

  16. Studies on acid-base status (Stewart's model) of young camels (Camelus dromedarius) after acid-load with NH4Cl.

    PubMed

    Elkhair, Nawal M; Hartmann, Helmut

    2010-01-01

    The identification of the reference values of Stewart variables and the changes in the acid-base status of the blood and urine in relation to the age after acid-load were studied in desert species of camels. 14 healthy young camels (age: 3-5 months) and 22 adult camels (age: 5-8 years) were used to provide the reference and percentile ranges of the Stewart variables. In the experiments, 24 healthy young camels (age: < 3-5 months) were infused with 5M NH4Cl solution (dose: 1.0 ml/kg) through a permanent intravenous catheter. Venous blood and urine samples were collected before infusion (0 hours). After the start of infusion, venous blood samples were collected at 2, 4, 6, 8 and 24 hours, and urine samples were collected at 8, 24 and 48 hours. Blood and urine samples were used for the determination of the various acid-base parameters, including the non-respiratory Stewart variables. The reference range of serum-[strong ion difference = SID3] was 39-52 mmol/l for all age groups. The reference values of serum-[acid total = A-] were between 10-17 mmol/l for all age groups. Serum-[Atotprotein] and -[Atot-albumin] showed a reference range of 19-24 mmol/I and 20-28 mmol/l, respectively. By 2-8 hours after the NH4Cl-load, the Stewart variables (serum-[SID3] and serum-[A(tot-protein)]) decreased significantly, and as a consequence, the blood pH decreased. Generally, the loaded young camels showed a transient moderate hyperchloraemic acidosis with a slight hypoproteinaemic alkalosis. These malfunctions were accompanied by increased renal fractional excretion of chloride and sodium and decreased urine pH. The identified reference values of the Stewart variables can be used for the clinical diagnosis of acid-base disturbances in camels. With the assistance of the non-respiratory Stewart variables ([SID3] and [Atot]), we can detect the determining influence of strong electrolytes (Na+, K+ and Cl-) and weak acids (proteins, Pi) on the physiological and pathological acid-base status of the animals.

  17. An improved reference measurement procedure for triglycerides and total glycerides in human serum by isotope dilution gas chromatography-mass spectrometry.

    PubMed

    Chen, Yizhao; Liu, Qinde; Yong, Sharon; Teo, Hui Ling; Lee, Tong Kooi

    2014-01-20

    Triglycerides are widely tested in clinical laboratories using enzymatic methods for lipid profiling. As enzymatic methods can be affected by interferences from biological samples, this together with the non-specific nature of triglycerides measurement makes it necessary to verify the accuracy of the test results with a reference measurement procedure. Several such measurement procedures had been published. These procedures generally involved lengthy and laborious sample preparation steps. In this paper, an improved reference measurement procedure for triglycerides and total glycerides was reported which simplifies the sample preparation steps and greatly shortens the time taken. The procedure was based on isotope dilution gas chromatography-mass spectrometry (IDGC-MS)with tripalmitin as the calibration standard. Serum samples were first spiked with isotope-labeled tripalmitin. For the measurement of triglycerides, the serum samples were subjected to lipid extraction followed by separation of triglycerides from diglycerides and monoglycerides. Triglycerides were then hydrolyzed to glycerol, derivatized and injected into the GC–MS for quantification. For the measurement of total glycerides, the serum samples were hydrolyzed directly and derivatized before injection into the GC-MS for quantification. All measurement results showed good precision with CV <1%. A certified reference material (CRM) of lipids in frozen human serum was used to verify the accuracy of the measurement. The obtained values for both triglycerides and total glycerides were well within the certified ranges of the CRM, with deviation <0.4% from the certified values. The relative expanded uncertainties were also comparable with the uncertainties associated with the certified values of the CRM. The validated procedure was used in an External Quality Assessment (EQA) Program organized by our laboratory to establish the assigned values for triglycerides and total glycerides.

  18. Effect of Feeding an Iodine-Restricted Diet in Cats with Spontaneous Hyperthyroidism.

    PubMed

    Hui, T Y; Bruyette, D S; Moore, G E; Scott-Moncrieff, J C

    2015-01-01

    Exclusive feeding of an iodine-restricted diet has been proposed as a method for controlling clinical manifestations of hyperthyroidism in hyperthyroid cats. To determine the effect of feeding an iodine-restricted diet on TT4 concentrations and clinical signs in cats with spontaneous hyperthyroidism. Forty-nine client-owned cats with spontaneous hyperthyroidism. Retrospective case series. Hyperthyroid cats were exclusively fed a commercially available iodine-restricted diet. Clinical response was assessed by change in weight and heart rate and serum TT4, blood urea nitrogen (BUN), and creatinine concentrations at various times during dietary management (21-60 days, 60-180 days). Serum TT4 normalized in 20/48 cats (42%) and 39/47 cats (83%) at 21-60 days and 61-180 days, respectively. Cats in which the TT4 concentrations were still above reference range at 21-60 days had a significantly higher starting TT4 than those that normalized their TT4 levels during the same time period (P = .038). Body weight did not significantly increase (P = .34) nor heart rate decrease (P = .64) during the study. There was a significant decrease in serum creatinine (P = .028). Cats in the low reference range for serum TT4 concentrations did not have a significant increase in body weight (P = .41) nor creatinine (P = .54) when compared to those with high reference range. Restricted-iodine diets were effective at maintaining serum TT4 concentrations within reference ranges for a majority of cats with spontaneous hyperthyroidism over 1 year, although not all clinical signs of hyperthyroidism improved. Copyright © 2015 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

  19. Reference Ranges for Serum Uric Acid among Healthy Assamese People

    PubMed Central

    Das, Madhumita; Borah, N. C.; Ghose, M.; Choudhury, N.

    2014-01-01

    This study was designed to establish reference ranges for serum uric acid among healthy adult Assamese population. Samples from 1470 aged 35–86 years were used to establish age and sex related reference range by the centile method (central 95 percentile) for serum uric acid level. There were 51% (n = 754) males and 49% (n = 716) females; 75.9% (n = 1115) of them were from urban area and the rest 24.1% (n = 355) were from the rural area. Majority of the population were nonvegetarian (98.6%, n = 1450) and only 1.4% (n = 20) were vegetarian. The mean age, weight, height, and uric acid of the studied group were 53.6 ± 11.3 years, 62.6 ± 10.5 kg, 160 ± 9.4 cm, and 5.5 ± 1.4 mg/dL, respectively. There is a statistically significant difference in the mean value of the abovementioned parameters between male and female. The observed reference range of uric acid in the population is 2.6–8.2 mg/dL which is wider than the current reference range used in the laboratory. Except gender (P < 0.0001), we did not find any significant relation of uric acid with other selected factors. PMID:24672726

  20. Serum Penicillin G Levels Are Lower Than Expected in Adults within Two Weeks of Administration of 1.2 Million Units

    PubMed Central

    Hansen, Christian J.; Russell, Kevin L.; Blumer, Jeffrey L.

    2011-01-01

    When introduced in the 1950s, benzathine penicillin G (BPG) was shown to be effective in eradicating group A beta-hemolytic streptococcus (GAS) for at least 3 weeks after administration. Several studies since the 1990s suggest that at 3–4 weeks serum penicillin G levels are less than adequate (below MIC90 of 0.016 µg/ml). We studied these levels for 4 weeks after the recommended dose of BPG in military recruits, for whom it is used as prophylaxis against GAS. The 329 subjects (mean age 20 years) each received 1.2 million units BPG IM and gave sera 1 day post injection and twice more at staggered time points over 4 weeks. Serum penicillin G levels were measured by liquid chromatography/tandem mass spectometry. The half-life of serum penicillin G was 4.1 days. By day 11, mean levels were <0.02 µg/ml, and by day 15<0.01 µg/ml. Levels in more than 50% of the subjects were below 0.02 µg/ml on day 9, and <.01 µg/ml on day 16. There was no demonstrable effect of subject body-surface area nor of the four different lots of BPG used. These data indicate that in healthy young adults serum penicillin G levels become less than protective <2½ weeks after injection of 1.2 million units of BPG. The findings require serious consideration in future medical and public health recommendations for treatment and prophylaxis of GAS upper respiratory tract infections. PMID:21991307

  1. The Kjeldahl method as a primary reference procedure for total protein in certified reference materials used in clinical chemistry. I. A review of Kjeldahl methods adopted by laboratory medicine.

    PubMed

    Chromý, Vratislav; Vinklárková, Bára; Šprongl, Luděk; Bittová, Miroslava

    2015-01-01

    We found previously that albumin-calibrated total protein in certified reference materials causes unacceptable positive bias in analysis of human sera. The simplest way to cure this defect is the use of human-based serum/plasma standards calibrated by the Kjeldahl method. Such standards, commutative with serum samples, will compensate for bias caused by lipids and bilirubin in most human sera. To find a suitable primary reference procedure for total protein in reference materials, we reviewed Kjeldahl methods adopted by laboratory medicine. We found two methods recommended for total protein in human samples: an indirect analysis based on total Kjeldahl nitrogen corrected for its nonprotein nitrogen and a direct analysis made on isolated protein precipitates. The methods found will be assessed in a subsequent article.

  2. Committee on Diabetes Mellitus Indices of the Japan Society of Clinical Chemistry-recommended reference measurement procedure and reference materials for glycated albumin determination.

    PubMed

    Takei, Izumi; Hoshino, Tadao; Tominaga, Makoto; Ishibashi, Midori; Kuwa, Katsuhiko; Umemoto, Masao; Tani, Wataru; Okahashi, Mikiko; Yasukawa, Keiko; Kohzuma, Takuji; Sato, Asako

    2016-01-01

    Glycated albumin is an intermediate glycaemic control marker for which there are several measurement procedures with entirely different reference intervals. We have developed a reference measurement procedure for the purpose of standardizing glycated albumin measurements. The isotope dilution liquid chromatography/tandem mass spectrometry method was developed as a reference measurement procedure for glycated albumin. The stable isotopes of lysine and fructosyl-lysine, which serve as an internal standard, were added to albumin isolated from serum, followed by hydrogenation. After hydrolysis of albumin with hot hydrochloric acid, the liberated lysine and fructosyl-lysine were measured by liquid chromatography/tandem mass spectrometry, and their concentrations were determined from each isotope ratio. The reference materials (JCCRM611) for determining of glycated albumin were prepared from pooled patient blood samples. The isotope dilution-tandem mass spectrometry calibration curve of fructosyl-lysine and lysine showed good linearity (r = 0.999). The inter-assay and intra-assay coefficient of variation values of glycated albumin measurement were 1.2 and 1.4%, respectively. The glycated albumin values of serum in patients with diabetes assessed through the use of this method showed a good relationship with routine measurement procedures (r = 0.997). The relationship of glycated albumin values of the reference material (JCCRM611) between these two methods was the same as the relationship with the patient serum samples. The Committee on Diabetes Mellitus Indices of the Japan Society of Clinical Chemistry recommends the isotope dilution liquid chromatography/tandem mass spectrometry method as a reference measurement procedure, and JCCRM611 as a certified reference material for glycated albumin measurement. In addition, we recommend the traceability system for glycated albumin measurement. © The Author(s) 2015.

  3. Effects of Arctium lappa L. (Burdock) root tea on inflammatory status and oxidative stress in patients with knee osteoarthritis.

    PubMed

    Maghsoumi-Norouzabad, Leila; Alipoor, Beitollah; Abed, Reza; Eftekhar Sadat, Bina; Mesgari-Abbasi, Mehran; Asghari Jafarabadi, Mohammad

    2016-03-01

    This study was designed to examine the effect of Burdock root tea on inflammatory markers and oxidative stress indicators in patients with knee osteoarthritis (OA). Thirty-six patients (10 men and 26 women) aged 50-70 years old with knee osteoarthritis referred to the Physical Medicine and Rehabilitation Department of the Tabriz University of Medical Sciences Hospitals, were selected for the study and randomly divided into two groups. Anthropometric measurements, including height, weight and body mass index (BMI) were measured. For all individuals along the 42 days of study period, the same drug treatments, including two lots of 500 mg acetaminophen twice a day and one glucosamine 500 mg once a day,were considered. The intervention group received daily three cups of Burdock root tea (each cup containing 2 g/150 mL boiled water) half-hour after the meal. The control group received three cups containing 150 cc boiled water daily. We assessed inflammatory markers such as high sensitivity C-reactive protein (hs-CRP) and interleukin-6 (IL-6) and oxidative stress indicators such as total antioxidants capacity (TAC), glutathione peroxidase (GPX), superoxide dismutase (SOD) and thiobarbituric acid reactive substances before and after the intervention. The results showed that burdock root tea significantly decreased the levels of serum IL-6 (P = 0.002), hs-CRP (P = 0.003) and malondialdehyde (P < 0.001), while the levels of serum TAC (P < 0.001) and activities of SOD (P = 0.009) were significantly increased. GPX activities increased but not significantly. The results suggested that Arctium lappa L. root tea improves inflammatory status and oxidative stress in patients with knee osteoarthritis. © 2014 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

  4. Blood serum chemistry of wild Alaskan Black-capped Chickadees (Poecile atricapillus) with avian keratin disorder

    USGS Publications Warehouse

    Van Hemert, Caroline R.; Handel, Colleen M.

    2016-01-01

    We measured serum chemistries in wild Black-capped Chickadees (Poecile atricapillus) from Alaska to test for potential differences associated with beak deformities characteristic of avian keratin disorder. Lower uric acid in affected birds was the only difference detected between groups, although sample sizes were small. This difference could be associated with fasting or malnutrition in birds with beak deformities, but it is challenging to interpret its biologic significance without reference values. Black-capped Chickadees had high levels of aspartate aminotransferase, lactate dehydrogenase, and creatine kinase relative to reference values for companion birds. However, all serum chemistry parameters from our study were within the range of values reported from other apparently healthy wild-caught birds.

  5. Re-recognition of Age-dependent Reference Range for the Serum Creatinine Level in Teenagers - A Case of Slowly Progressive Tubulointerstitial Nephritis which Occurred in an Adolescent.

    PubMed

    Ono, Hiroyuki; Nagai, Kojiro; Shibata, Eriko; Matsuura, Motokazu; Kishi, Seiji; Inagaki, Taizo; Minato, Masanori; Yoshimoto, Sakiya; Ueda, Sayo; Obata, Fumiaki; Nishimura, Kenji; Tamaki, Masanori; Kishi, Fumi; Murakami, Taichi; Abe, Hideharu; Kinoshita, Yukiko; Urushihara, Maki; Kagami, Shoji; Doi, Toshio

    2017-08-15

    For the first time, a 15-year-old boy was found to have a slight degree of proteinuria and microscopic hematuria during annual school urinalysis screening. His kidney function had already severely deteriorated. A kidney biopsy revealed tubulointerstitial nephritis (TIN) with diffuse inflammatory cell infiltration. His medical records showed his serum creatinine level to be 0.98 mg/dL two years ago, which was abnormally high considering his age. Although the etiology of slowly progressive TIN was unclear, glucocorticoid and immunosuppressant therapy improved his kidney function. This case report suggests that all doctors should recognize the reference range for the serum creatinine level in teenagers.

  6. Re-recognition of Age-dependent Reference Range for the Serum Creatinine Level in Teenagers - A Case of Slowly Progressive Tubulointerstitial Nephritis which Occurred in an Adolescent -

    PubMed Central

    Ono, Hiroyuki; Nagai, Kojiro; Shibata, Eriko; Matsuura, Motokazu; Kishi, Seiji; Inagaki, Taizo; Minato, Masanori; Yoshimoto, Sakiya; Ueda, Sayo; Obata, Fumiaki; Nishimura, Kenji; Tamaki, Masanori; Kishi, Fumi; Murakami, Taichi; Abe, Hideharu; Kinoshita, Yukiko; Urushihara, Maki; Kagami, Shoji; Doi, Toshio

    2017-01-01

    For the first time, a 15-year-old boy was found to have a slight degree of proteinuria and microscopic hematuria during annual school urinalysis screening. His kidney function had already severely deteriorated. A kidney biopsy revealed tubulointerstitial nephritis (TIN) with diffuse inflammatory cell infiltration. His medical records showed his serum creatinine level to be 0.98 mg/dL two years ago, which was abnormally high considering his age. Although the etiology of slowly progressive TIN was unclear, glucocorticoid and immunosuppressant therapy improved his kidney function. This case report suggests that all doctors should recognize the reference range for the serum creatinine level in teenagers. PMID:28781321

  7. Reference Proteome Extracts for Mass Spec Instrument Performance Validation and Method Development

    PubMed Central

    Rosenblatt, Mike; Urh, Marjeta; Saveliev, Sergei

    2014-01-01

    Biological samples of high complexity are required to test protein mass spec sample preparation procedures and validate mass spec instrument performance. Total cell protein extracts provide the needed sample complexity. However, to be compatible with mass spec applications, such extracts should meet a number of design requirements: compatibility with LC/MS (free of detergents, etc.)high protein integrity (minimal level of protein degradation and non-biological PTMs)compatibility with common sample preparation methods such as proteolysis, PTM enrichment and mass-tag labelingLot-to-lot reproducibility Here we describe total protein extracts from yeast and human cells that meet the above criteria. Two extract formats have been developed: Intact protein extracts with primary use for sample preparation method development and optimizationPre-digested extracts (peptides) with primary use for instrument validation and performance monitoring

  8. Effect of delayed serum separation and storage temperature on serum glucose concentration in horse, dog, alpaca, and sturgeon.

    PubMed

    Collicutt, Nancy B; Garner, Bridget; Berghaus, Roy D; Camus, Melinda S; Hart, Kelsey

    2015-03-01

    Although delays between blood sample collection and analysis are common in veterinary medicine, the effect of prolonged serum-clot contact time on serum glucose concentration is not well established and species differences have not been elucidated. The objective was to investigate the effect of storage time and temperature on serum glucose concentration in stored whole blood samples from horse, dog, alpaca, and sturgeon. Whole blood specimens were divided into 7 no-additive tubes and serum was separated from one sample within one hour, serving as the reference sample. The remaining samples were stored at 4°C and 25°C, then centrifuged and serum glucose measured by automated analysis at 2, 4, and 8 hours postcollection. Glucose concentrations were compared using linear mixed models. The decline in serum glucose concentration for all samples stored at 4°C was not statistically significant, except for the 8-hour samples from sturgeon and dog. At 25°C, serum glucose concentration was comparable to reference values at 2 hours in sturgeon and alpaca, but significantly lower at 4 and 8 hours in those species, and at all time points in equine and canine specimens, being most prominent after 8 hours of storage in canine specimens. Storage at 4°C limits serum glucose decline for at least 4 hours in all species tested and up to 8 hours in specimens of horse and alpaca. At 25°C, serum-clot contact time should not exceed 1 hour in equine and canine samples, and 2 hours in specimens from alpaca and sturgeon. © 2014 American Society for Veterinary Clinical Pathology.

  9. Racial difference in serum Vitamin B/sub 12/ levels

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kwee, H.G.; Bowman, H.S.; Wells, L.W.

    1985-07-01

    Measurements of the serum Vitamin B/sub 12/ concentrations of 49 black and 49 white healthy adults demonstrate a significantly higher mean serum Vitamin B/sub 12/ level in blacks when compared to whites. The reason for this difference appears to be genetic, although environmental factors may also be involved. It is suggested that clinical laboratories should establish their own separate reference values of serum Vitamin B/sub 12/ for blacks and whites in order to prevent misinterpretation of test results.

  10. An assessment of contemporary atomic spectroscopic techniques for the determination of lead in blood and urine matrices

    NASA Astrophysics Data System (ADS)

    Parsons, Patrick J.; Geraghty, Ciaran; Verostek, Mary Frances

    2001-09-01

    The preparation and validation of a number of clinical reference materials for the determination of lead in blood and urine is described. Four candidate blood lead reference materials (Lots, 047-050), and four candidate urine lead reference materials (Lots, 034, 035, 037 and 038), containing physiologically-bound lead at clinically relevant concentrations, were circulated to up to 21 selected laboratories specializing in this analysis. Results from two interlaboratory studies were used to establish certified values and uncertainty estimates for these reference materials. These data also provided an assessment of current laboratory techniques for the measurement of lead in blood and urine. For the blood lead measurements, four laboratories used electrothermal atomization AAS, three used anodic stripping voltammetry and one used both ETAAS and ICP-MS. For the urine lead measurements, 11 laboratories used ETAAS (most with Zeeman background correction) and 10 used ICP-MS. Certified blood lead concentrations, ±S.D., ranged from 5.9±0.4 μg/dl (0.28±0.02 μmol/l) to 76.0±2.2 μg/dl (3.67±0.11 μmol/l) and urine lead concentrations ranged from 98±5 μg/l (0.47±0.02 μmol/l) to 641±36 μg/l (3.09±0.17 μmol/l). The highest concentration blood lead material was subjected to multiple analyses using ETAAS over an extended time period. The data indicate that more stringent internal quality control practices are necessary to improve long-term precision. While the certification of blood lead materials was accomplished in a manner consistent with established practices, the urine lead materials proved more troublesome, particularly at concentrations above 600 μg/l (2.90 μmol/l).

  11. From a Gloss to a Learning Tool: Does Visual Aids Enhance Better Sentence Comprehension?

    ERIC Educational Resources Information Center

    Sato, Takeshi; Suzuki, Akio

    2012-01-01

    The aim of this study is to optimize CALL environments as a learning tool rather than a gloss, focusing on the learning of polysemous words which refer to spatial relationship between objects. A lot of research has already been conducted to examine the efficacy of visual glosses while reading L2 texts and has reported that visual glosses can be…

  12. EFFECT OF THE LEVEL AND TYPE OF DIETARY FAT ON THE METABOLISM OF CHOLESTEROL AND BETA LIPOPROTEINS IN THE CEBUS MONKEY

    PubMed Central

    Portman, Oscar W.; Hegsted, D. Mark; Stare, Fredrick J.; Bruno, Dorothy; Murphy, Robert; Sinisterra, Leonardo

    1956-01-01

    A study was carried out to determine the effect of the level and type of dietary fat on the concentration of cholesterol and beta lipoproteins in the sera of Cebus monkeys. Three groups of monkeys were fed isocaloric diets containing a fixed ratio of alpha protein and cholesterol to calories but with different amounts of corn oil and sucrose. Corn oil provided 10, 32, and 45 per cent of the calories in the three diets, and the level of sucrose was varied inversely. After 8 weeks the serum cholesterol and Sf 12 to 100 beta lipoprotein concentrations were significantly greater in the medium and high fat groups. When corn oil was decreased from 45 to 10 per cent of dietary calories and sucrose was increased, the serum cholesterol fell in all cases, and when the reverse change was made, the concentration of serum cholesterol increased. Variation in dietary sucrose had no specific effect. Substitution of starch for sucrose with diets otherwise constant did not cause significant change in the concentration of serum cholesterol. When monkeys fed corn oil diets at any of three levels were changed to hydrogenated cottonseed oil diets at the same level, the serum cholesterol and Sf 12 to 100 beta lipoproteins rose. However, hydrogenated cottonseed oil had no greater hypercholesteremic effect than did corn oil in the absence of dietary cholesterol. Diets containing lard with cholesterol also produced strikingly greater serum lipide responses than did diets based on corn oil and cholesterol. Hydrogenated cottonseed oil had a greater hypercholesteremic effect than an unhydrogenated cottonseed oil from the same lot. Preliminary studies indicated that the saturated fats (hydrogenated cottonseed oil) produced the most striking elevation of serum cholesterol values (above controls fed corn oil) when casein was the dietary protein. PMID:13376806

  13. Age-Specific Normal Reference Range for Serum Anti-Müllerian Hormone in Healthy Chinese Han Women: A nationwide Population-Based Study.

    PubMed

    Du, Xiaofang; Ding, Ting; Zhang, Hanwang; Zhang, Cuilian; Ma, Wenmin; Zhong, Ying; Qu, Wenyu; Zheng, Jie; Liu, Yi; Li, Zhiying; Huang, Kecheng; Deng, Song; Ma, Lanfang; Yang, Jun; Jiang, Jingjing; Yang, Shuhong; Huang, Jia; Wu, Meng; Fang, Li; Lu, Yunping; Luo, Aiyue; Wang, Shixuan

    2016-08-01

    The increasing use of anti-Müllerian hormone (AMH) in clinic has raised concerns regarding the reliable reference range for this test. However, the reference range for AMH in normal Chinese female population has not been established. Furthermore, relationship between AMH and other clinical markers such as body mass index (BMI) and antral follicle counts (AFCs) and other sex-related hormones have not been examined in normal population-based women. We aimed to determine the age-specific reference range for serum AMH in healthy Chinese women throughout reproductive age to menopause and to estimate relationship between AMH and other clinical markers in healthy women. In this multicenter and nationwide study, advertisements were used to recruit 2055 women, aged 20 to 55 years, from 6 different regions in China; 1590 (77.37%) women met the inclusion criteria for the reference range population. We measured the baseline serum AMH levels using new Beckman Coulter Gen II assay. Serum concentration of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), testosterone (T), prolactin (PRL), progesterone (PRG), and AFCs were also determined in the follicular phase. The AMH-Age nomogram and AMH levels of different age-groups and the relationship between AMH and other clinical markers. Serum AMH concentrations declined progressively with age. A quadratic model defined as log (AMH) = (-1.970 + 0.296 × Age - 0.006 × Age(2)) fitted best the decline of AMH with age. The median AMH levels were 6.23, 5.65, 4.55, 3.74, 2.78, and 1.09 ng/mL for the 20 ≤ age < 25, 25 ≤ age < 30, 30 ≤ age < 33, 33 ≤ age < 37, 37 ≤ age < 40, and 40 ≤ age < 55 groups, respectively. The 5th to 95th percentiles of the AMH levels, as the reference range, were 2.06 to 12.66, 1.77 to 13.83, 1.48 to 11.45, 0.87 to 9.76, 0.56 to 9.49, and 0.08 to 5.70 ng/mL for each age-group. The AMH levels were positively correlated with AFCs and T, LH, PRL and PRG levels and negatively correlated with BMI and FSH levels and were not significantly correlated with E2 levels. The relationship between AMH and other variables remain unchanged except for PRL, which was not significantly correlated with AMH levels after controlling for both age and BMI. This study determined the normal reference ranges for serum AMH levels in a large population-based sample of healthy Chinese women. © The Author(s) 2016.

  14. Biochemical and hematologic reference values for free-ranging, chemically immobilized wild norwegian reindeer (rangifer tarandus tarandus) during early winter.

    PubMed

    Miller, Andrea L; Evans, Alina L; Os, Øystein; Arnemo, Jon M

    2013-04-01

    Hematologic and serum biochemistry values were evaluated in free-ranging, wild Norwegian reindeer (Rangifer tarandus tarandus) as part of a reintroduction program in southwestern Norway in November 1995 and 1996. Animals were immobilized with medetomidine-ketamine by dart from a helicopter. Blood was drawn for serum chemistry from 31 adults (nine males and 22 females) and for hematology from 29 adults (eight males and 21 females). Significant differences (P<0.05) were found between male and female results for alkaline phosphatase, selenium, and zinc. Although there was a significant difference between male and female gamma-globulin values and the total albumin:globulin ratio, the overall values are much lower than those reported for other Rangifer species. Sexual differences should be interpreted with caution due to the low number of males compared to females. References ranges are presented combining male and female results for hematology and serum chemistry and separately for males and females for serum electrophoresis. No correlation was found between induction time and aspartate transaminase, creatine kinase, glucose, cortisol, or total protein. Blood values were generally similar to those published for semidomestic reindeer (Rangifer tarandus tarandus) and free-ranging caribou (Rangifer tarandus caribou), but the effect of capture drugs, stress, season, and sample size should be considered with interpretation. This paper provides the first report of baseline hematologic and serum biochemistry reference ranges for free-ranging, wild Norwegian reindeer during early winter.

  15. Multicentre physiological reference intervals for serum concentrations of immunoglobulins A, G and M, complement C3c and C4 measured with Tina-Quant reagents systems.

    PubMed

    Fuentes-Arderiu, Xavier; Alonso-Gregorio, Eduardo; Alvarez-Funes, Virtudes; Ambrós-Marigómez, Carmen; Coca-Fábregas, Lluís; Cruz-Placer, Marta; Díaz-Fernández, Julián; Pinel-Julián, María Pilar; Gutiérrez-Cecchini, Beatriz; Herrero-Bernal, Pilar; Sempere-Alcocer, Marcos; García-Caballero, Francisca; Del Mar Larrea-Ortiz-Quintana, María; La-Torre-Marcellán, Pedro; Del Señor López-Vélez, María; Mar-Medina, Carmen; Martín-Oncina, Javier; Rodríguez-Hernández, María Victoria; Romero-Sotomayor, María Victoria; Serrano-López, Cándido; Sicilia-Enríquez-de-Salamanca, Adolfo; Velasco-Romero, Ana María; Juvé-Cuxart, Santiago

    2007-01-01

    Clinical laboratories seeking accreditation for compliance with ISO 15189:2003 need to demonstrate that the physiological reference intervals communicated to all users of the laboratory service are appropriate for the patient population served and for the measurement systems used. In the case of immunological quantities, few articles have been published in peer-reviewed journals. A total of 21 clinical laboratories in different regions of Spain collaborated in identifying reference individuals and determining adult reference intervals for some immunological quantities measured using RD/Hitachi Modular Analytics analysers and Tina-Quant reagent systems. These immunological quantities are the mass concentrations of immunoglobulin A, immunoglobulin G, immunoglobulin M, complement C3c and complement C4 in serum. All the logistic work was carried out in co-operation with the supplier of the reagents and analysers (Roche Diagnostics España, S.L., Sant Cugat del Vallès, Catalonia, Spain). From the set of reference values obtained by each laboratory, multicentre reference limits were estimated non-parametrically. The reference intervals estimated in this study for concentrations of serum components under consideration are: complement C3c, 0.62-1.64 g/L for women and men; complement C4, 0.14-0.72 g/L for women and men; immunoglobulin A, 0.89-4.80 g/L for women and men; immunoglobulin G, 6.5-14.3 g/L for women and men; and immunoglobulin M, 0.48-3.38 g/L for women and 0.41-2.46 g/L for men.

  16. Reference Intervals of Alpha-Fetoprotein and Carcinoembryonic Antigen in the Apparently Healthy Population.

    PubMed

    Zhang, Gao-Ming; Guo, Xu-Xiao; Ma, Xiao-Bo; Zhang, Guo-Ming

    2016-12-12

    BACKGROUND The aim of this study was to calculate 95% reference intervals and double-sided limits of serum alpha-fetoprotein (AFP) and carcinoembryonic antigen (CEA) according to the CLSI EP28-A3 guideline. MATERIAL AND METHODS Serum AFP and CEA values were measured in samples from 26 000 healthy subjects in the Shuyang area receiving general health checkups. The 95% reference intervals and upper limits were calculated by using MedCalc. RESULTS We provided continuous reference intervals from 20 years old to 90 years old for AFP and CEA. The reference intervals were: AFP, 1.31-7.89 ng/ml (males) and 1.01-7.10 ng/ml (females); CEA, 0.51-4.86 ng/ml (males) and 0.35-3.45ng/ml (females). AFP and CEA were significantly positively correlated with age in both males (r=0.196 and r=0.198) and females (r=0.121 and r=0.197). CONCLUSIONS Different races or populations and different detection systems may result in different reference intervals for AFP and CEA. Continuous reference intervals of age changes are more accurate than age groups.

  17. Reference values assessment in a Mediterranean population for small dense low-density lipoprotein concentration isolated by an optimized precipitation method.

    PubMed

    Fernández-Cidón, Bárbara; Padró-Miquel, Ariadna; Alía-Ramos, Pedro; Castro-Castro, María José; Fanlo-Maresma, Marta; Dot-Bach, Dolors; Valero-Politi, José; Pintó-Sala, Xavier; Candás-Estébanez, Beatriz

    2017-01-01

    High serum concentrations of small dense low-density lipoprotein cholesterol (sd-LDL-c) particles are associated with risk of cardiovascular disease (CVD). Their clinical application has been hindered as a consequence of the laborious current method used for their quantification. Optimize a simple and fast precipitation method to isolate sd-LDL particles and establish a reference interval in a Mediterranean population. Forty-five serum samples were collected, and sd-LDL particles were isolated using a modified heparin-Mg 2+ precipitation method. sd-LDL-c concentration was calculated by subtracting high-density lipoprotein cholesterol (HDL-c) from the total cholesterol measured in the supernatant. This method was compared with the reference method (ultracentrifugation). Reference values were estimated according to the Clinical and Laboratory Standards Institute and The International Federation of Clinical Chemistry and Laboratory Medicine recommendations. sd-LDL-c concentration was measured in serums from 79 subjects with no lipid metabolism abnormalities. The Passing-Bablok regression equation is y = 1.52 (0.72 to 1.73) + 0.07 x (-0.1 to 0.13), demonstrating no significant statistical differences between the modified precipitation method and the ultracentrifugation reference method. Similarly, no differences were detected when considering only sd-LDL-c from dyslipidemic patients, since the modifications added to the precipitation method facilitated the proper sedimentation of triglycerides and other lipoproteins. The reference interval for sd-LDL-c concentration estimated in a Mediterranean population was 0.04-0.47 mmol/L. An optimization of the heparin-Mg 2+ precipitation method for sd-LDL particle isolation was performed, and reference intervals were established in a Spanish Mediterranean population. Measured values were equivalent to those obtained with the reference method, assuring its clinical application when tested in both normolipidemic and dyslipidemic subjects.

  18. Reference intervals for serum reactive oxygen metabolites, biological antioxidant potential, and oxidative stress index in adult rams.

    PubMed

    Oikonomidis, Ioannis L; Kiosis, Evangelos A; Brozos, Christos N; Kritsepi-Konstantinou, Maria G

    2017-03-01

    OBJECTIVE To establish reference intervals for serum reactive oxygen metabolites (ROMs), biological antioxidant potential (BAP), and oxidative stress index (OSi) in adult rams by use of controlled preanalytic and analytic procedures. ANIMALS 123 healthy 1- to 4-year-old rams of 2 Greek breeds (Chios [n = 62] and Florina [61]). PROCEDURES 4 hours after rams were fed, a blood sample was obtained from each ram, and serum was harvested. Concentrations of ROMs and BAP were measured colorimetrically on a spectrophotometric analyzer. The OSi was calculated as ROMs concentration divided by BAP concentration. Combined and breed-specific reference intervals were calculated by use of nonparametric and robust methods, respectively. Reference intervals were defined as the 2.5th to 97.5th percentiles. RESULTS Reference intervals for ROMs, BAP, and OSi for all rams combined were 65 to 109 Carratelli units, 2,364 to 4,491 μmol/L, and 18.2 to 43.0 Carratelli units/(mmol/L), respectively. Reference intervals of Chios rams for ROMs, BAP, and OSi were 56 to 113 Carratelli units, 2,234 to 4,290 μmol/L, and 12.9 to 38.4 Carratelli units/(mmol/L), respectively. Reference intervals of Florina rams for ROMs, BAP, and OSi were 68 to 111 Carratelli units, 2,337 to 4,363 μmol/L, and 14.1 to 38.1 Carratelli units/(mmol/L), respectively. CONCLUSIONS AND CLINICAL RELEVANCE Reference intervals calculated in this study can be used as a guide for the interpretation of ROMs, BAP, and OSi results in rams and, under appropriate conditions, can be adopted for use by veterinary laboratories.

  19. Choice of Reference Serum Creatinine in Defining AKI

    PubMed Central

    Siew, Edward D.; Matheny, Michael E.

    2015-01-01

    Background/Aims The study of acute kidney injury (AKI) has expanded with the increasing availability of electronic health records and the use of standardized definitions. Understanding the impact of AKI between settings is limited by heterogeneity in the selection of reference creatinine to anchor the definition of AKI. In this mini-review, we discuss different approaches used to select reference creatinine and their relative merits and limitations. Methods We reviewed the literature to obtain representative examples of published baseline creatinine definitions when pre-hospital data were not available, as well as literature evaluating estimation of baseline renal function, using Pubmed and reference back-tracing within known works. Results 1) Prehospital creatinine values are useful in determining reference creatinine, and in high-risk populations, the mean outpatient serum creatinine value 7-365 days before hospitalization closely approximates nephrology adjudication, 2) in patients without pre-hospital data, the eGFR 75 approach does not reliably estimate true AKI incidence in most at-risk populations 3) using the lowest inpatient serum creatinine may be reasonable, especially in those with preserved kidney function, but may generously estimate AKI incidence and severity and miss community-acquired AKI that does not fully resolve, 4) using more specific definitions of AKI (e.g. KIDGO Stage 2 and 3) may help to reduce the effects of misclassification when using surrogate values, and 5) leveraging available clinical data may help refine the estimate of reference creatinine. Conclusions Choosing reference creatinine for AKI calculation is important for AKI classification and study interpretation. We recommend obtaining data on pre-hospital kidney function, wherever possible. In studies where surrogate estimates are used, transparency in how they are applied and discussion that informs the reader of potential biases should be provided. Further work to refine the estimation of reference creatinine is needed. PMID:26332325

  20. Serum Beta Hydroxybutyrate Concentrations in Cats with Chronic Kidney Disease, Hyperthyroidism, or Hepatic Lipidosis.

    PubMed

    Gorman, L; Sharkey, L C; Armstrong, P J; Little, K; Rendahl, A

    2016-01-01

    Ketones, including beta hydroxybutyrate (BHB), are produced in conditions of negative energy balance and decreased glucose utilization. Serum BHB concentrations in cats are poorly characterized in diseases other than diabetes mellitus. Serum BHB concentrations will be increased in cats with chronic kidney disease (CKD), hyperthyroidism (HT), or hepatic lipidosis (HL). Twenty-eight client-owned cats with CKD, 34 cats with HT, and 15 cats with HL; 43 healthy cats. Prospective observational study. Serum BHB concentrations were measured at admission in cats with CKD, HT, and HL, for comparison with a reference interval established using healthy cats. Results of dipstick urine ketone measurement, when available, were compared to BHB measurement. Beta hydroxybutyrate was above the reference interval (<0.11 mmol/L) in 6/28 cats (21%) with CKD, 7/34 cats (20%) with HT, and 11/15 cats (73%) with HL, significantly exceeding the expected 2.5% above the reference interval for healthy cats (P < .001 for all groups). Elevations were mild in CKD and HT groups (median BHB 0.1 mmol/L for both groups, 80th percentile 0.12 and 0.11 mmol/L, respectively), but more marked in HL cats (median BHB 0.2 mmol/L, 80th percentile 0.84 mmol/L). None of 11 cats with increased serum BHB concentration having urine dipstick analysis performed within 24 h of sampling for BHB were ketonuric. Increases in serum BHB concentrations occur in cats with CKD, HT, and HL, and might provide an useful index of catabolism. Copyright © 2016 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

  1. Association of Serum Thyrotropin with Anthropometric Markers of Obesity in the General Population.

    PubMed

    Tiller, Daniel; Ittermann, Till; Greiser, Karin H; Meisinger, Christa; Agger, Carsten; Hofman, Albert; Thuesen, Betina; Linneberg, Allan; Peeters, Robin; Franco, Oscar; Heier, Margit; Kluttig, Alexander; Werdan, Karl; Stricker, Bruno; Schipf, Sabine; Markus, Marcello; Dörr, Marcus; Völzke, Henry; Haerting, Johannes

    2016-09-01

    Except from associations study with body weight, there are few longitudinal data regarding the association between thyroid function and anthropometric measurements such as waist circumference, waist-to-hip ratio, or waist-to height ratio. This study aimed to investigate the association of thyrotropin (TSH) at baseline with changes in different anthropometric markers between baseline and follow-up in the general population. Data were used from four population-based longitudinal cohort studies and one population-based cross-sectional study. A total of 16,902 (8204 males) subjects aged 20-95 years from the general population were studied. Body mass index, waist circumference, waist-to-hip ratio, and waist-to-height ratio were measured. Multivariable median regression models were calculated adjusting for the following covariates: age, sex, baseline value of the respective anthropometric marker, smoking status, follow-up-time period, and study site. In cross-sectional analyses, serum TSH within the reference range was positively associated with waist circumference (β = 0.94 cm [confidence interval (CI) 0.56-1.32]) and waist-to-height-ratio (β = 0.029 [CI 0.017-0.042]). These associations were also present for the full range of TSH. In the longitudinal analyses, serum TSH at baseline was inversely associated with a five-year change of all considered anthropometric measures within the prior defined study-specific reference range, as well as in the full range of serum TSH. High TSH serum levels were positively associated with current anthropometric markers, even in the study-specific reference ranges. In contrast, high TSH serum levels were associated with decreased anthropometric markers over a time span of approximately five years. Further research is needed to determine possible clinical implications as well as public health consequences of these findings.

  2. Serum chemistry reference values for the common genet (Genetta genetta): variations associated with Leishmania infantum infection.

    PubMed

    Millán, Javier; Chirife, Andrea D; Altet, Laura

    2015-03-01

    The role of wildlife in the epidemiology of leishmaniosis in under debate, and determining whether infection with Leishmania infantum causes illness in wild carnivores is important to determine its potential role as a reservoir. To provide for the first time serum biochemistry reference values for the common genet (Genetta genetta), and to determine variations associated with L. infantum infection. Twenty-five serum biochemistry parameters were determined in 22 wild-caught genets. Blood samples were analyzed for L. infantum DNA by means of real-time polymerase chain reaction (PCR). Two female genets were positive for L. infantum DNA but did not show any external clinical sign upon physical examination. Among other variations in the biochemistry values of these genets, one presented a higher concentration of gamma-globulins and cholesterol, whereas the other genet presented increased creatinine, bilirubin, and chloride levels when compared to uninfected females. Sex-related differences in some parameters were also reported. Infection with L. infantum may sometimes be accompanied by abnormal serum biochemistry in wild carnivores. Clinical disease may occur in L. infantum-infected wild carnivores. This has implications in the epidemiology of leishmaniosis. In addition, the data provided here would also be useful as reference values for researchers or rehabilitators working with the common genet.

  3. Determination of perfluorinated alkyl acid concentrations in human serum and milk standard reference materials.

    PubMed

    Keller, Jennifer M; Calafat, Antonia M; Kato, Kayoko; Ellefson, Mark E; Reagen, William K; Strynar, Mark; O'Connell, Steven; Butt, Craig M; Mabury, Scott A; Small, Jeff; Muir, Derek C G; Leigh, Stefan D; Schantz, Michele M

    2010-05-01

    Standard Reference Materials (SRMs) are certified reference materials produced by the National Institute of Standards and Technology that are homogeneous materials well characterized with values for specified properties, such as environmental contaminant concentrations. They can be used to validate measurement methods and are critical in improving data quality. Disagreements in perfluorinated alkyl acid (PFAA) concentrations measured in environmental matrices during past interlaboratory comparisons emphasized the need for SRMs with values assigned for PFAAs. We performed a new interlaboratory comparison among six laboratories and provided, for the first time, value assignment of PFAAs in SRMs. Concentrations for perfluorooctane sulfonate (PFOS), perfluorooctanoate (PFOA), and other PFAAs in two human serum and two human milk SRMs are reported. PFAA concentration measurements agreed for serum SRM 1957 using different analytical methods in six laboratories and for milk SRM 1954 in three laboratories. The interlaboratory relative standard deviation for PFOS in SRM 1957 was 7%, which is an improvement over past interlaboratory studies. Matrix interferences are discussed, as well as temporal trends and the percentage of branched vs. linear isomers. The concentrations in these SRMs are similar to the present-day average concentrations measured in human serum and milk, resulting in representative and useful control materials for PFAA human monitoring studies.

  4. A New Method with General Diagnostic Utility for the Calculation of Immunoglobulin G Avidity

    PubMed Central

    Korhonen, Maria H.; Brunstein, John; Haario, Heikki; Katnikov, Alexei; Rescaldani, Roberto; Hedman, Klaus

    1999-01-01

    The reference method for immunoglobulin G (IgG) avidity determination includes reagent-consuming serum titration. Aiming at better IgG avidity diagnostics, we applied a logistic model for the reproduction of antibody titration curves. This method was tested with well-characterized serum panels for cytomegalovirus, Epstein-Barr virus, rubella virus, parvovirus B19, and Toxoplasma gondii. This approach for IgG avidity calculation is generally applicable and attains the diagnostic performance of the reference method while being less laborious and twice as cost-effective. PMID:10473525

  5. Combined use of serum HCG and sonography in the diagnosis of ectopic pregnancy

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kadar, N.; Taylor, K.J.W.; Rosenfield, A.T.

    1983-09-01

    During an 18 month period, 320 patients were referred with clinical suspicion of an ectopic pregnancy. This study is based on 19 patients with ectopic pregnancy who had both a sonographic examination of the pelvis and determination of serum beta human chorionic gonadotropin (HCG) before surgery. Emphasis is focused on the spectrum of sonographic appearances that may occur in ectopic gestation. These are illustrated, and the sonographic criteria that have been used both for a positive diagnosis and for the exclusion of ectopic pregnancy in the past are analyzed. It is suggested that the accuracy of sonography can be increasedmore » by determining the serum HCG level on the day of the scan and by interpreting the findings with reference to the discriminatory HCG zone.« less

  6. Age specific serum anti-Müllerian hormone levels in 1,298 Korean women with regular menstruation

    PubMed Central

    Yoo, Ji Hee; Cha, Sun Wha; Park, Chan Woo; Yang, Kwang Moon; Song, In Ok; Koong, Mi Kyoung; Kang, Inn Soo

    2011-01-01

    Objective To determine the age specific serum anti-Müllerian hormone (AMH) reference values in Korean women with regular menstruation. Methods Between May, 2010 and January, 2011, the serum AMH levels were evaluated in a total of 1,298 women who have regular menstrual cycles aged between 20 and 50 years. Women were classified into 6 categories by age: 20-31 years, 32-34 years, 35-37 years, 38-40 years, 41-43 years, above 43 years. Measurement of serum AMH was measured by commercial enzyme-linked immunoassay. Results The serum AMH levels correlated negatively with age. The median AMH level of each age group was 4.20 ng/mL, 3.70 ng/mL, 2.60 ng/mL, 1.50 ng/mL, 1.30 ng/mL, and 0.60 ng/mL, respectively. The AMH values in the lower 5th percentile of each age group were 1.19 ng/mL, 0.60 ng/mL, 0.42 ng/mL, 0.27 ng/mL, 0.14 ng/mL, and 0.10 ng/mL, respectively. Conclusion This study determined reference values of serum AMH in Korean women with regular menstruation. These values can be applied to clinical evaluation and treatment of infertile women. PMID:22384425

  7. Hematology and serum clinical chemistry reference intervals for free-ranging Scandinavian gray wolves (Canis lupus).

    PubMed

    Thoresen, Stein I; Arnemo, Jon M; Liberg, Olof

    2009-06-01

    Scandinavian free-ranging wolves (Canis lupus) are endangered, such that laboratory data to assess their health status is increasingly important. Although wolves have been studied for decades, most biological information comes from captive animals. The objective of the present study was to establish reference intervals for 30 clinical chemical and 8 hematologic analytes in Scandinavian free-ranging wolves. All wolves were tracked and chemically immobilized from a helicopter before examination and blood sampling in the winter of 7 consecutive years (1998-2004). Seventy-nine blood samples were collected from 57 gray wolves, including 24 juveniles (24 samples), 17 adult females (25 samples), and 16 adult males (30 samples). Whole blood and serum samples were stored at refrigeration temperature for 1-3 days before hematologic analyses and for 1-5 days before serum biochemical analyses. Reference intervals were calculated as 95% confidence intervals except for juveniles where the minimum and maximum values were used. Significant differences were observed between adult and juvenile wolves for RBC parameters, alkaline phosphatase and amylase activities, and total protein, albumin, gamma-globulins, cholesterol, creatinine, calcium, chloride, magnesium, phosphate, and sodium concentrations. Compared with published reference values for captive wolves, reference intervals for free-ranging wolves reflected exercise activity associated with capture (higher creatine kinase activity, higher glucose concentration), and differences in nutritional status (higher urea concentration).

  8. Preparation of Chemical Compounds for the U.S. Army Drug Development Program

    DTIC Science & Technology

    1990-09-14

    Aldrich, Lot No. ML0824ML Johns Manville , no Lot No. J.T. Baker, Lot No. A42837 Fisher Scientific Lot No. 885835-60 Ashland, Lot No. 0701768E...Aldrich, Lot No. 03905ET Moore-Tec, No Lot No. Lot Nos. KAPM and KDPA Aaper, Lot Nos. R9529, 89D19-R, 89K06 Kodak, Lot No. 807198C Johns Manville , Lot...89-K06-R and 90-A124-R Fisher, Lot Nos. 881166-60, 895184-36 and 894961-36 Kodak, Lot NO. 807198C Johns Manville Lot Nos. G5P34633 and 3P-291

  9. BiliChek transcutaneous bilirubin meter overestimates serum bilirubin as measured by the Doumas reference method.

    PubMed

    Karon, Brad S; Wickremasinghe, Andrea C; Lo, Stanley F; Saenger, Amy K; Cook, Walter J

    2010-08-01

    To determine the relationship between BiliChek TcB (Respironics, Marietta GA) and Doumas reference serum or plasma total bilirubin (TSB). Pooled samples with values assigned by the Doumas reference method were used to establish the relationship between a local laboratory and reference Doumas TSB. We then established the relationship between TcB and TSB in the 3 months before and after reassignment of calibrator setpoints undertaken to match the local laboratory to Doumas reference bilirubin values. Before calibrator setpoint reassignment TSB as measured in our laboratory overestimated Doumas reference bilirubin. After calibrator adjustment laboratory TSB was within 1.7-6.8 micromol/L (0.1-0.4 mg/dL) of Doumas reference values. Mean bias between BiliChek TcB and TSB was 42.8+/-22.2 micromol/L (2.5+/-1.3mg/dL) (n=94) before and 49.6+/-22.2 micromol/L (2.9+/-1.3mg/dL) (n=115) after calibration adjustment. BiliChek TcB significantly overestimates TSB as measured by the Doumas reference method. 2010 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  10. Serum concentrations of symmetric dimethylarginine and creatinine in cats with kidney stones.

    PubMed

    Hall, Jean A; Yerramilli, Maha; Obare, Edward; Li, Jun; Yerramilli, Murthy; Jewell, Dennis E

    2017-01-01

    Serum concentrations of symmetric dimethylarginine (SDMA) correlate with renal function in cats and SDMA has been shown to be a more reliable and earlier marker for chronic kidney disease (CKD) compared with serum creatinine (Cr). Calcium oxalate uroliths tend to develop in mid-to-older aged cats and kidney stones may cause a reduction in renal function with increased SDMA, but normal serum Cr. The purpose of this retrospective study was to determine if cats with kidney stones had increased serum SDMA concentrations, and whether SDMA increased earlier than serum creatinine concentrations. Cats in the colony with kidney stones diagnosed between August 2010 and December 2015 (n = 43) were compared with healthy geriatric cats (n = 21) without kidney stones. Serum SDMA concentrations were determined by liquid chromatography-mass spectrometry and serum Cr concentrations were determined by enzymatic colorimetry. Cats with kidney stones were diagnosed antemortem by radiographic imaging (n = 12) or by postmortem necropsy (n = 31). Retrospectively, serum SDMA was found to be increased above the upper reference limit in 39 of 43 cats with kidney stones. Serum Cr was increased above the upper reference limit in 18 of 43 cats; 6 of these 18 cats had terminal azotemia only. The mean time that serum SDMA was increased before serum Cr was increased was 26.9 months (range 0 to 60 months). Kidney stones were composed of calcium oxalate in 30 of 34 cats. The lifespan for cats with kidney stones (mean, 12.5 years; range, 6.1 to 18.1 years) was shorter (P < 0.001) than for control cats (mean, 15.2 years; range, 13.0 to 17.2 years), suggesting that non-obstructive kidney stones have an effect on mortality rate or rate of CKD progression. In conclusion, if SDMA concentrations are elevated in mid-to-older aged cats, further imaging studies are warranted to check for the presence of kidney stones.

  11. Serum concentrations of symmetric dimethylarginine and creatinine in cats with kidney stones

    PubMed Central

    Hall, Jean A.; Yerramilli, Maha; Obare, Edward; Li, Jun; Yerramilli, Murthy; Jewell, Dennis E.

    2017-01-01

    Serum concentrations of symmetric dimethylarginine (SDMA) correlate with renal function in cats and SDMA has been shown to be a more reliable and earlier marker for chronic kidney disease (CKD) compared with serum creatinine (Cr). Calcium oxalate uroliths tend to develop in mid-to-older aged cats and kidney stones may cause a reduction in renal function with increased SDMA, but normal serum Cr. The purpose of this retrospective study was to determine if cats with kidney stones had increased serum SDMA concentrations, and whether SDMA increased earlier than serum creatinine concentrations. Cats in the colony with kidney stones diagnosed between August 2010 and December 2015 (n = 43) were compared with healthy geriatric cats (n = 21) without kidney stones. Serum SDMA concentrations were determined by liquid chromatography-mass spectrometry and serum Cr concentrations were determined by enzymatic colorimetry. Cats with kidney stones were diagnosed antemortem by radiographic imaging (n = 12) or by postmortem necropsy (n = 31). Retrospectively, serum SDMA was found to be increased above the upper reference limit in 39 of 43 cats with kidney stones. Serum Cr was increased above the upper reference limit in 18 of 43 cats; 6 of these 18 cats had terminal azotemia only. The mean time that serum SDMA was increased before serum Cr was increased was 26.9 months (range 0 to 60 months). Kidney stones were composed of calcium oxalate in 30 of 34 cats. The lifespan for cats with kidney stones (mean, 12.5 years; range, 6.1 to 18.1 years) was shorter (P < 0.001) than for control cats (mean, 15.2 years; range, 13.0 to 17.2 years), suggesting that non-obstructive kidney stones have an effect on mortality rate or rate of CKD progression. In conclusion, if SDMA concentrations are elevated in mid-to-older aged cats, further imaging studies are warranted to check for the presence of kidney stones. PMID:28384169

  12. Analysis of the economic impact of the national unified carbon trading market mechanism Hebei province, for example

    NASA Astrophysics Data System (ADS)

    Sun, Yuxing

    2018-05-01

    In this paper, a grey prediction model is used to predict the carbon emission in Hebei province, and the impact analysis model based on TermCo2 is established. At the same time, we read a lot about CGE and study on how to build the scene, the selection of key parameters, and sensitivity analysis of application scenarios do industry for reference.

  13. Start Your Search Engines. Part One: Taming Google--and Other Tips to Master Web Searches

    ERIC Educational Resources Information Center

    Adam, Anna; Mowers, Helen

    2008-01-01

    There are a lot of useful tools on the Web, all those social applications, and the like. Still most people go online for one thing--to perform a basic search. For most fact-finding missions, the Web is there. But--as media specialists well know--the sheer wealth of online information can hamper efforts to focus on a few reliable references.…

  14. Comprehensive Characterization of Reference Standard Lots of HIV-1 Subtype C Gp120 Proteins for Clinical Trials in Southern African Regions

    PubMed Central

    Wang, Zihao; Lorin, Clarisse; Koutsoukos, Marguerite; Franco, David; Bayat, Babak; Zhang, Ying; Carfi, Andrea; Barnett, Susan W.; Porter, Frederick

    2016-01-01

    Two HIV-1 subtype C gp120 protein candidates were the selected antigens for several experimental vaccine regimens now under evaluation in HVTN 100 Phase I/II clinical trial aiming to support the start of the HVTN 702 Phase IIb/III trial in southern Africa, which is designed to confirm and extend the partial protection seen against HIV-1 infection in the RV144 Thai trial. Here, we report the comprehensive physicochemical characterization of the gp120 reference materials that are representative of the clinical trial materials. Gp120 proteins were stably expressed in Chinese Hamster Ovary (CHO) cells and subsequently purified and formulated. A panel of analytical techniques was used to characterize the physicochemical properties of the two protein molecules. When formulated in the AS01 Adjuvant System, the bivalent subtype C gp120 antigens elicited 1086.C- and TV1.C-specific binding antibody and CD4+ T cell responses in mice. All the characteristics were highly representative of the Clinical Trial Materials (CTM). Data from this report demonstrate the immunogenicity of the gp120 antigens, provide comprehensive characterization of the molecules, set the benchmark for assessment of current and future CTM lots, and lay the physicochemical groundwork for interpretation of future clinical trial data. PMID:27187483

  15. A comparison of LMC and SDL complexity measures on binomial distributions

    NASA Astrophysics Data System (ADS)

    Piqueira, José Roberto C.

    2016-02-01

    The concept of complexity has been widely discussed in the last forty years, with a lot of thinking contributions coming from all areas of the human knowledge, including Philosophy, Linguistics, History, Biology, Physics, Chemistry and many others, with mathematicians trying to give a rigorous view of it. In this sense, thermodynamics meets information theory and, by using the entropy definition, López-Ruiz, Mancini and Calbet proposed a definition for complexity that is referred as LMC measure. Shiner, Davison and Landsberg, by slightly changing the LMC definition, proposed the SDL measure and the both, LMC and SDL, are satisfactory to measure complexity for a lot of problems. Here, SDL and LMC measures are applied to the case of a binomial probability distribution, trying to clarify how the length of the data set implies complexity and how the success probability of the repeated trials determines how complex the whole set is.

  16. 3. A 40-years record of the polymetallic pollution of the Lot River system, France

    NASA Astrophysics Data System (ADS)

    Audry, S.; Schäfer, J.; Blanc, G.; Veschambre, S.; Jouanneau, J.-M.

    2003-04-01

    The Lot River system (southwest France) is known for historic Zn and Cd pollution that originates from Zn ore treatment in the small Riou-Mort watershed and affects seafood production in the Gironde Estuary. We present a sedimentary record from 2 cores taken in a dam lake downstream of the Riou-Mort watershed covering the evolution of metal inputs into the Lot River over the past 40 years (1960-2001). Depth profiles of Cd, Zn, Cu and Pb concentrations are comparable indicating common sources and transport. The constant Zn/Cd ratio (˜50) observed in the sediment cores is similar to that in SPM from the Riou-Mort watershed, indicating the dominance of point source pollution upon the geochemical background signal. Cadmium, Zn, Cu and Pb concentrations in the studied sediment cores show an important peak in 42-44 cm depth with up to 300 mg.kg-1 (Cd), 10,000 mg.kg-1 (Zn), 150 mg.kg-1 (Cu) and 930 mg.kg-1 (Pb). These concentrations are much higher than geochemical background values; For example, Cd concentrations are more than 350-fold higher than those measured in the same riverbed upstream the confluence with the Riou-Mort River. This peak coincides with the upper 137Cs peak resulting from the Chernobyl accident (1986). Therefore, this heavy metal peak is attributed to the latest accidental Cd pollution of the Lot-River in 1986. Several downward heavy metal peaks reflect varying input probably due to changes in industrial activities within the Riou-Mort watershed. Given mean sedimentation rate of about 2 cm.yr-1, the record suggests constant and much lower heavy metal concentrations since the early nineties due to restriction of industrial activities and remediation efforts in the Riou-Mort watershed. Nevertheless, Cd, Zn, Cu and Pb concentrations in the upper sediment remain high, compared to background values from reference sites in the upper Lot River system.

  17. Evaluation of an anal sac adenocarcinoma tumor in a Spitz dog

    PubMed Central

    Javanbakht, Javad; Tavassoli, Abbas; Sabbagh, Atefeh; Hassan, Mehdy Aghamohammmad; Samakkhah, Shohreh Alian; Shafiee, Radmehr; Lakzian, Ali; Ghalee, Vahideh Rahmani; Gharebagh, Sonia Shoja

    2013-01-01

    A 9-year-old emasculated male Spitz with tenesmus and constipation had a subcutaneous mass at the left ventral aspect of the anus with history of polyuria and polydipsia. A complete blood cell count, serum biochemistry panel, and urinalysis (cystocentesis sample) were evaluated. Abnormalities in the serum biochemistry panel included a mildly elevated serum cholesterol concentration (7.28 mmol/L; reference interval, 2.70–5.94 mmol/L), increased serum alkaline phosphatase activity (184 U/L; reference interval, 9–90 U/L), alanine transaminase (122 U/L; reference interval, 5–60 U/L) activity and aspartate aminotransferase (80 U/L; reference interval, 5–55 U/L) activity, severe increased total calcium concentration (16.3 mg/dL; reference interval, 8.2–12.4 mg/dL or 9.3–11.4 mg/dL), and decreased total calcium concentration (3.4 mg/dL, reference interval, 2.5–5.6mg/dL). Furthermore, testing revealed an increased intact parathyroid hormone concentration (38.6 pmol/L; reference interval, 3–17 pmol/L). On cytologic and histopathologic examinations, various types of cells were observed. Most of the cells were oval to polygonal and had elliptical or elongate nuclei and a moderate amount of pale to basophilic cytoplasm. The remaining cells had round to oval nuclei and pale to basophilic cytoplasm. Cells of both types were loosely adhered to each other and were arranged in rosette-like structures. Both neoplastic cell types had fine homogenous chromatin and either a small indistinct nucleolus or no visible nucleolus. Mild anisokaryosis and anisocytosis were observed. Histologically, the mass consists of glandular structures formed by cuboidal cells admixed with bundles of spindle cells. Based on location and histologic features, the final diagnosis was adenocarcinoma of the apocrine gland of the anal sac, which should be included as a cytologic differential diagnosis when spindle cells and typical epithelial cells are observed in masses in the region of the anal sac of dogs. PMID:23570021

  18. Colon Reference Set Application: Nam Kim - DiaDexus (2008) — EDRN Public Portal

    Cancer.gov

    The EDRN Colorectal reference samples will be useful in confirming the potential application of novel serum markers for colorectal cancer that can detect presence of cancer in high-risk asymptomatic patients.

  19. Stability of total nutrient admixtures in reference to ambient temperatures.

    PubMed

    Lee, Myung Duk; Yoon, Jeung-Ei; Kim, Sang-In; Kim, In-Chul

    2003-10-01

    To evaluate the stability of emulsions under different temperatures simulating clinical conditions of storage and exposure during infusion, five total nutrient admixture formulas in this institution were analyzed: adult, patients with hepatic failure, infants, stressed patients, and patients with renal failure. Each mixture was allocated in a sterile 100-mL glass bottle, which was prefilled and refilled with nitrogen gas. Bottles were stored at 4 degrees C for 0 d, 3 d, and 7 d and then exposed to three different temperatures: usual room temperature (18 degrees C to 25 degrees C), high (>28 degrees C) in a water bath, or storage (4 degrees C) for 24 and 48 h. The gross inspection of the emulsions and parallel measurements of pH, particle sizes, divalent ions, peroxide levels, and microbial cultures were performed. Every lot was stable near 18 degrees C, but 8 of 10 lots stored for 7 d (25 degrees C and >28 degrees C) and 15 of 20 lots stored for 3 and 7 d (25 degrees C and >28 degrees C) showed coalescence. The overall coalescence incidences by storage, exposure, and heat were statistically significant (P < 0.005). For the safety of total nutrient admixtures, special attention is required to keep the ambient temperature below 28 degrees C and completely exclude air from the container.

  20. Occupational exposure levels of bioaerosol components are associated with serum levels of the acute phase protein Serum Amyloid A in greenhouse workers.

    PubMed

    Madsen, Anne Mette; Thilsing, Trine; Bælum, Jesper; Garde, Anne Helene; Vogel, Ulla

    2016-01-20

    Occupational exposure to particles may be associated with increased inflammation of the airways. Animal experiments suggest that inhaled particles also induce a pulmonary acute phase response, leading to systemic circulation of acute phase proteins. Greenhouse workers are exposed to elevated levels of bioaerosols. The objective of this study is to assess whether greenhouse workers personal exposure to bioaerosol components was associated with serum levels of the acute phase proteins Serum Amyloid A (SAA) and C-reactive protein (CRP). SAA and CRP levels were determined in serum sampled repeatedly from 33 greenhouse workers. Blood was drawn repeatedly on Mondays and Thursdays during work weeks. Acute phase protein levels were compared to levels in a comparison group of 42 people and related to individual exposure levels to endotoxin, dust, bacteria, fungi and β-glucan. Serum levels of SAA and CRP were not significantly different in greenhouse workers and a reference group, or on the two work days. In a mixed model, SAA levels were positively associated with endotoxin exposure levels (p = 0.0007). Results for fungi were not clear. CRP levels were positively associated with endotoxin exposures (p = 0.022). Furthermore, when workers were categorized into three groups based on SAA and CRP serum levels endotoxin exposure was highest in the group with the highest SAA levels and in the group with middle and highest CRP levels. SAA and CRP levels were elevated in workers with asthma. Greenhouse workers did not have elevated serum levels of SAA and CRP compared to a reference group. However, occupational exposure to endotoxin was positively associated with serum levels of the acute phase proteins SAA and CRP. Preventive measures to reduce endotoxin exposure may be beneficial.

  1. Prevalence and prognostic importance of hypomagnesemia and hypocalcemia in horses that have colic surgery.

    PubMed

    Garcia-Lopez, J M; Provost, P J; Rush, J E; Zicker, S C; Burmaster, H; Freeman, L M

    2001-01-01

    To determine the prevalence of hypomagnesemia and hypocalcemia in horses with surgical colic. 35 horses with surgically managed colic. Serum concentrations of total magnesium (tMg2+) and calcium (tCa2+), as well as ionized magnesium (iMg2+) and calcium (iCa2+) were analyzed before surgery and 1, 3, 5, and 7 days following surgery. A lead-II ECG and pertinent clinical data were also obtained at each time. Preoperative serum tMg2+ and iMg2+ concentrations were below the reference range in 6 (17%) and 19 (54%) horses, respectively. Serum concentrations of tCa2+ and iCa2+ were less than the reference range in 20 (57%) and 30 (86%) horses before surgery. Horses with strangulating lesions of the gastrointestinal tract had significantly lower preoperative serum concentrations of iMg2+ and iCa2+, as well as a higher heart rate than horses with nonstrangulating lesions. Horses that developed postoperative ileus had significantly lower serum concentrations of iMg2+ after surgery. Serum concentrations of magnesium and calcium (total and ionized) correlated significantly with the PR, QRS, QT, and corrected QT (QTc) intervals. Horses that were euthanatized at the time of surgery (n = 7) had significantly lower preoperative serum concentrations of iMg2+, compared with horses that survived. Neither serum magnesium nor calcium concentrations were predictors of hospitalization time or survival. Hypomagnesemia and hypocalcemia were common during the perioperative period, particularly in horses with strangulating intestinal lesions and ileus. Serum concentrations of tMg2+ and tCa2+ were less sensitive than iMg2+ and iCa2+ in detecting horses with hypomagnesemia and hypocalcemia.

  2. Thyroid function in 36 dogs with leishmaniosis due to Leishmania infantum before and during treatment with allopurinol with or without meglumine antimonate.

    PubMed

    Saridomichelakis, Manolis N; Xenoulis, Panagiotis G; Chatzis, Manolis K; Kasabalis, Dimitris; Steiner, Jörg M; Suchodolski, Jan S; Petanides, Theodoros

    2013-10-18

    Hypothyroidism may predispose to the development of canine leishmaniosis or it may appear during the course of the latter due to infiltration and destruction of the thyroid gland by infected macrophages. The main purpose of this study was to evaluate thyroid function through measurement of serum total thyroxin (tT₄), free thyroxin (fT₄), and canine thyroid stimulating hormone (cTSH) concentrations in 36 dogs with leishmaniosis, before and after 2 and 4 weeks of treatment with allopurinol with or without meglumine antimonate. Before treatment 27/36 (75%) dogs had serum tT₄ concentrations below the lower limit of the reference interval but only 2 of them had concurrently serum fT₄ concentrations below the lower limit of the reference interval and none had increased serum cTSH concentrations. During treatment there were no significant changes in serum tT₄ or fT₄ concentrations, whereas a significant increase in serum cTSH was observed. Two dogs had decreased serum tT₄ and fT₄ but normal cTSH concentrations before treatment and two other dogs had decreased serum tT₄ and increased cTSH, but normal fT₄ concentrations during the treatment period. Although hypothyroidism could not be definitively excluded in these dogs it is considered unlikely based on their overall hormonal profile, clinical presentation, and response to treatment. Therefore, hypothyroidism does not appear to be an important predisposing disease or a frequent complication of canine leishmaniosis. Copyright © 2013 Elsevier B.V. All rights reserved.

  3. Serum levels of brominated flame retardants (BFRs: PBDE, HBCD) and influence of dietary factors in a population-based study on Swedish adults.

    PubMed

    Bjermo, Helena; Aune, Marie; Cantillana, Tatiana; Glynn, Anders; Lind, P Monica; Ridefelt, Peter; Darnerud, Per Ola

    2017-01-01

    The aim of this study was to investigate associations between serum concentrations of brominated flame retardants and personal characteristics, including diet, in adults participating in a population-based study in Sweden 2010-11. Moreover, observed concentrations were used in a health risk assessment, using published health-based reference values. Serum samples of 170 adult individuals of both sexes were analyzed for 10 PBDE congeners and HBCD by GC-MS. When including concentrations between LOD and LOQ, highest median serum concentration was observed for BDE-153 (1.2 ng/g serum lipid), followed by BDE-209 (0.95 ng/g lipid), BDE-47 (0.49 ng/g lipid) and BDE-100 (0.21 ng/g lipid). Median concentration of HBCD was 0.10 ng/g lipid. A few markedly elevated concentrations of BDE-209, HBCD (77-78 ng/g lipid) and BDE-47 (44 ng/g lipid) were observed. The only statistical significant findings were higher BDE-153 concentrations in men than in women, and positive associations between serum BDE-153 concentrations and consumption of fish (total), beef, mutton and poultry. PBDE concentrations were in accordance with concentrations reported in other European countries but generally lower than those found in North America. Median PBDE serum concentrations observed in adults from Sweden suggest sufficient health protection, when compared with published health-based reference values, although some outliers with high serum concentrations had lower safety margins. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  4. Evaluation of serum biochemical marker concentrations and survival time in dogs with protein-losing enteropathy.

    PubMed

    Equilino, Mirjam; Théodoloz, Vincent; Gorgas, Daniela; Doherr, Marcus G; Heilmann, Romy M; Suchodolski, Jan S; Steiner, Jörg M; Burgener Dvm, Iwan A

    2015-01-01

    To evaluate serum concentrations of biochemical markers and survival time in dogs with protein-losing enteropathy (PLE). Prospective study. 29 dogs with PLE and 18 dogs with food-responsive diarrhea (FRD). Data regarding serum concentrations of various biochemical markers at the initial evaluation were available for 18 of the 29 dogs with PLE and compared with findings for dogs with FRD. Correlations between biochemical marker concentrations and survival time (interval between time of initial evaluation and death or euthanasia) for dogs with PLE were evaluated. Serum C-reactive protein concentration was high in 13 of 18 dogs with PLE and in 2 of 18 dogs with FRD. Serum concentration of canine pancreatic lipase immunoreactivity was high in 3 dogs with PLE but within the reference interval in all dogs with FRD. Serum α1-proteinase inhibitor concentration was less than the lower reference limit in 9 dogs with PLE and 1 dog with FRD. Compared with findings in dogs with FRD, values of those 3 variables in dogs with PLE were significantly different. Serum calprotectin (measured by radioimmunoassay and ELISA) and S100A12 concentrations were high but did not differ significantly between groups. Seventeen of the 29 dogs with PLE were euthanized owing to this disease; median survival time was 67 days (range, 2 to 2,551 days). Serum C-reactive protein, canine pancreatic lipase immunoreactivity, and α1-proteinase inhibitor concentrations differed significantly between dogs with PLE and FRD. Most initial biomarker concentrations were not predictive of survival time in dogs with PLE.

  5. Reference measurement procedure for total glycerides by isotope dilution GC-MS.

    PubMed

    Edwards, Selvin H; Stribling, Shelton L; Pyatt, Susan D; Kimberly, Mary M

    2012-04-01

    The CDC's Lipid Standardization Program established the chromotropic acid (CA) reference measurement procedure (RMP) as the accuracy base for standardization and metrological traceability for triglyceride testing. The CA RMP has several disadvantages, including lack of ruggedness. It uses obsolete instrumentation and hazardous reagents. To overcome these problems the CDC developed an isotope dilution GC-MS (ID-GC-MS) RMP for total glycerides in serum. We diluted serum samples with Tris-HCl buffer solution and spiked 200-μL aliquots with [(13)C(3)]-glycerol. These samples were incubated and hydrolyzed under basic conditions. The samples were dried, derivatized with acetic anhydride and pyridine, extracted with ethyl acetate, and analyzed by ID-GC-MS. Linearity, imprecision, and accuracy were evaluated by analyzing calibrator solutions, 10 serum pools, and a standard reference material (SRM 1951b). The calibration response was linear for the range of calibrator concentrations examined (0-1.24 mmol/L) with a slope and intercept of 0.717 (95% CI, 0.7123-0.7225) and 0.3122 (95% CI, 0.3096-0.3140), respectively. The limit of detection was 14.8 μmol/L. The mean %CV for the sample set (serum pools and SRM) was 1.2%. The mean %bias from NIST isotope dilution MS values for SRM 1951b was 0.7%. This ID-GC-MS RMP has the specificity and ruggedness to accurately quantify total glycerides in the serum pools used in the CDC's Lipid Standardization Program and demonstrates sufficiently acceptable agreement with the NIST primary RMP for total glyceride measurement.

  6. Assessment of thyroid function during first-trimester pregnancy: what is the rational upper limit of serum TSH during the first trimester in Chinese pregnant women?

    PubMed

    Li, Chenyan; Shan, Zhongyan; Mao, Jinyuan; Wang, Weiwei; Xie, Xiaochen; Zhou, Weiwei; Li, Chenyang; Xu, Bin; Bi, Lihua; Meng, Tao; Du, Jianling; Zhang, Shaowei; Gao, Zhengnan; Zhang, Xiaomei; Yang, Liu; Fan, Chenling; Teng, Weiping

    2014-01-01

    Guidelines of the American Thyroid Association (ATA) proposed that the upper limit of the TSH reference range should be 2.5 mIU/L in first trimester, but the reported ranges in China are significantly higher. Our objective was to establish a rational reference range of serum TSH for diagnosis of subclinical hypothyroidism in the first trimester of pregnant women in China. We screened 4800 pregnant women in the first trimester and 2000 women who planned to become pregnant and evaluated 535 pregnant women in follow-up visits during the second and third trimester. Median concentrations of serum TSH decreased significantly from the seventh week of gestation. The median of TSH from 4 to 6 weeks was significantly higher than from 7 to 12 weeks (2.15 [0.56-5.31] mIU/L vs 1.47 [0.10-4.34] mIU/L, P<.001); however, there was no significant difference compared with nonpregnant women (2.07 [0.69-5.64] mIU/L; P=.784). The median of free T4 was not significantly altered in the first trimester. The prevalence of subclinical hypothyroidism in the 4800 pregnant women was 27.8% on the diagnostic criteria of TSH>2.5 mIU/L and 4.0% using the reference interval derived by our laboratory (0.14-4.87 mIU/L).Additionally, of 118 pregnant women who had serum TSH>2.5 mIU/L in the first trimester, only 30.0% and 20.3% of them at the 20th and 30th week of gestation had TSH>3.0 mIU/L. The reference range for nonpregnant women can be used for the assessment of pregnant women at 4 to 6 weeks of gestation. The upper limit of serum TSH in the first trimester was much higher than 2.5 mIU/L in Chinese pregnant women.

  7. Comparison of methods used to diagnose generalized inflammatory disease in manatees (Trichechus manatus latirostris)

    USGS Publications Warehouse

    Harr, K.E.; Harvey, J.W.; Bonde, R.K.; Murphy, D.; Lowe, Mark; Menchaca, M.; Haubold, E.M.; Francis-Floyd, R.

    2006-01-01

    Manatees (Trichechus manatus latirostris) are afflicted with inflammatory and infectious disease secondary to human interaction, such as boat strike and entanglement, as well as “cold stress syndrome” and pneumonia. White-blood-cell count and fever, primary indicators of systemic inflammation in most species, are insensitive in diagnosing inflammatory disease in manatees. Acute phase-response proteins, such as haptoglobin and serum amyloid A, have proven to be sensitive measures of inflammation/infection in domestic large animal species. This study assessed diagnosis of generalized inflammatory disease by different methods including total white-blood-cell count, albumin: globulin ratio, gel electrophoresis analysis, C-reactive protein, alpha1 acid glycoprotein, haptoglobin, fibrinogen, and serum amyloid A. Samples were collected from 71 apparently healthy and 27 diseased animals during diagnostic medical examination. Serum amyloid A, measured by ELISA, followed by albumin:globulin ratio, measured by plasma gel electrophoresis, were most sensitive in diagnosing inflammatory disease, with diagnostic sensitivity and specificity of approximately 90%. The reference interval for serum amyloid A is <10–50 μg/ml with an equivocal interval of 51–70 μg/ml. The reference interval for albumin:globulin ratio by plasma gel electrophoresis is 0.7–1.1. Albumin: globulin ratio, calculated using biochemical techniques, was not accurate due to overestimation of albumin by bromcresol green dye-binding methodology. Albumin:globulin ratio, measured by serum gel electrophoresis, has a low sensitivity of 15% due to the lack of fibrinogen in the sample. Haptoglobin, measured by hemoglobin titration, had a reference interval of 0.4–2.4 mg/ml, a diagnostic sensitivity of 60%, and a diagnostic specificity of 93%. The haptoglobin assay is significantly affected by hemolysis. Fibrinogen, measured by heat precipitation, has a reference interval of 100–400 mg/dl, a diagnostic sensitivity of 40%, and a diagnostic specificity of 95%.

  8. Comparison of methods used to diagnose generalized inflammatory disease in manatees (Trichechus manatus latirostris).

    PubMed

    Harr, Kendal; Harvey, John; Bonde, Robert; Murphy, David; Lowe, Mark; Menchaca, Maya; Haubold, Elsa; Francis-Floyd, Ruth

    2006-06-01

    Manatees (Trichechus manatus latirostris) are afflicted with inflammatory and infectious disease secondary to human interaction, such as boat strike and entanglement, as well as "cold stress syndrome" and pneumonia. White-blood-cell count and fever, primary indicators of systemic inflammation in most species, are insensitive in diagnosing inflammatory disease in manatees. Acute phase-response proteins, such as haptoglobin and serum amyloid A, have proven to be sensitive measures of inflammation/infection in domestic large animal species. This study assessed diagnosis of generalized inflammatory disease by different methods including total white-blood-cell count, albumin: globulin ratio, gel electrophoresis analysis, C-reactive protein, alpha, acid glycoprotein, haptoglobin, fibrinogen, and serum amyloid A. Samples were collected from 71 apparently healthy and 27 diseased animals during diagnostic medical examination. Serum amyloid A, measured by ELISA, followed by albumin:globulin ratio, measured by plasma gel electrophoresis, were most sensitive in diagnosing inflammatory disease, with diagnostic sensitivity and specificity of approximately 90%. The reference interval for serum amyloid A is <10-50 microg/ml with an equivocal interval of 51-70 microg/ml. The reference interval for albumin:globulin ratio by plasma gel electrophoresis is 0.7-1.1. Albumin: globulin ratio, calculated using biochemical techniques, was not accurate due to overestimation of albumin by bromcresol green dye-binding methodology. Albumin:globulin ratio, measured by serum gel electrophoresis, has a low sensitivity of 15% due to the lack of fibrinogen in the sample. Haptoglobin, measured by hemoglobin titration, had a reference interval of 0.4-2.4 mg/ml, a diagnostic sensitivity of 60%, and a diagnostic specificity of 93%. The haptoglobin assay is significantly affected by hemolysis. Fibrinogen, measured by heat precipitation, has a reference interval of 100-400 mg/dl, a diagnostic sensitivity of 40%, and a diagnostic specificity of 95%.

  9. Serum 25-hydroxyvitamin D and breast cancer in the military: a case-control study utilizing pre-diagnostic serum.

    PubMed

    Mohr, Sharif B; Gorham, Edward D; Alcaraz, John E; Kane, Christopher I; Macera, Caroline A; Parsons, J Kellogg; Wingard, Deborah L; Horst, Ronald; Garland, Cedric F

    2013-03-01

    The objective of this study was to ascertain whether a relationship exists between pre-diagnostic serum levels of 25-hydroxyvitamin D (25(OH)D) and risk of breast cancer in young women. About 600 incident cases of breast cancer were matched to 600 controls as part of a nested case-control study that utilized pre-diagnostic sera. Logistic regression was used to assess the relationship between serum 25(OH)D concentration and breast cancer risk, controlling for race and age. According to the conditional logistic regression for all subjects, odds ratios for breast cancer by quintile of serum 25(OH)D from lowest to highest were 1.2, 1.0, 0.9, 1.1, and 1.0 (reference) (p trend = 0.72). After multivariate regression for subjects whose blood had been collected within 90 days preceding diagnosis, odds ratios for breast cancer by quintile of serum 25(OH)D from lowest to highest were 3.3, 1.9, 1.7, 2.6, and 1.0 (reference) (p trend = 0.09). An inverse association between serum 25(OH)D concentration and risk of breast cancer was not present in the principal analysis, although an inverse association was present in a small subgroup analysis of subjects whose blood had been collected within 90 days preceding diagnosis. Further prospective studies of 25(OH)D and breast cancer risk are needed.

  10. [Impaired renal function: be aware of exogenous factors].

    PubMed

    van der Meijden, Wilbert A G; Smak Gregoor, Peter J H

    2013-01-01

    Renal function is currently estimated using the Modification of Diet in Renal Disease (MDRD) formula, which is partly based on the serum creatinine level. Patients with impaired renal function are referred to nephrologists in accordance with the Dutch national transmural agreement for 'Chronic renal impairment'. A 54-year-old woman without significant history was referred to analyse a coincidentally found decline in the estimated glomerular filtration rate (eGFR). The patient had no complaints and used no medication except creatine supplements. Additional diagnostic testing showed no abnormalities. After cessation of creatine supplementation, the calculated renal function normalized. Serum creatinine is a reflection of muscle mass. The use of creatine-containing dietary supplements, such as creatine ethyl ester, can influence serum creatinine levels and therefore the eGFR as calculated with the MDRD formula. The use of supplements deserves attention when taking the history.

  11. 77 FR 53906 - Notice of Proposed Withdrawal and Opportunity for Public Meeting; California

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-04

    ...\\; Sec. 32, lots 4 and 5; Sec. 34, lot 4. T. 13 N., R. 10 E., Sec. 2, lot 1, and lots 3 to 15, inclusive; Sec. 9, lots 8, 12, and 13, and SW\\1/4\\NE\\1/4\\; Sec. 10, lots 1 to 10, inclusive, E\\1/2\\NE\\1/4\\, E\\1/2..., inclusive, S\\1/2\\ of lot 5, S\\1/2\\ of lot 8, lots 11 and 13; Sec. 19, lot 24; Sec. 20, lots 1, 2, 3, and 8...

  12. Reference Intervals of Alpha-Fetoprotein and Carcinoembryonic Antigen in the Apparently Healthy Population

    PubMed Central

    Zhang, Gao-Ming; Guo, Xu-Xiao; Ma, Xiao-Bo; Zhang, Guo-Ming

    2016-01-01

    Background The aim of this study was to calculate 95% reference intervals and double-sided limits of serum alpha-fetoprotein (AFP) and carcinoembryonic antigen (CEA) according to the CLSI EP28-A3 guideline. Material/Methods Serum AFP and CEA values were measured in samples from 26 000 healthy subjects in the Shuyang area receiving general health checkups. The 95% reference intervals and upper limits were calculated by using MedCalc. Results We provided continuous reference intervals from 20 years old to 90 years old for AFP and CEA. The reference intervals were: AFP, 1.31–7.89 ng/ml (males) and 1.01–7.10 ng/ml (females); CEA, 0.51–4.86 ng/ml (males) and 0.35–3.45ng/ml (females). AFP and CEA were significantly positively correlated with age in both males (r=0.196 and r=0.198) and females (r=0.121 and r=0.197). Conclusions Different races or populations and different detection systems may result in different reference intervals for AFP and CEA. Continuous reference intervals of age changes are more accurate than age groups. PMID:27941709

  13. Variation of calcium, copper and iron levels in serum, bile and stone samples of patients having different types of gallstone: A comparative study.

    PubMed

    Khan, Mustafa; Kazi, Tasneem Gul; Afridi, Hassan Imran; Sirajuddin; Bilal, Muhammad; Akhtar, Asma; Khan, Sabir; Kadar, Salma

    2017-08-01

    Epidemiological data among the human population has shown a significantly increased incidence of gallstone (GS) disease worldwide. It was studied that some essential (calcium) and transition elements (iron and copper) in bile play an important role in the development of GS. The estimation of calcium, copper and iron were carried out in the serum, gall bladder bile and different types of GS (cholesterol, mixed and pigmented) of 172 patients, age ranged 20-55years. For comparative purpose age matched referents not suffering from GS diseases were also selected. Biliary concentrations of calcium (Ca), iron (Fe) and copper (Cu) were correlated with their concentrations in serum and different types of GS samples. The ratio of Ca, Fe and Cu in bile with serum was also calculated. Understudy metals were determined by flame atomic absorption spectroscopy after acid decomposition of matrices of selected samples. The Ca concentrations in serum samples were significantly higher in patients with pigmented GS as compared to controls (p<0.005), whereas for patients having cholesterol and mixed GS the concentrations were on the lower side. Biliary Ca concentrations of patients were found to be higher than controls, but difference was significant for pigmented GS patients (p>0.001). The contents of Cu and Fe in serum and bile of all patients (except female cholesterol GS patient have low serum iron concentration) were found to be higher than control, but difference was significant in those patients who have pigmented GS. The concentration of Ca, Fe and Cu in different types GS were found in the order, Pigmented>mixed>cholesterol. The bile/serum ratio for Ca, Cu and Fe was found to be significantly higher in pigmented GS patients. Gall bladder bile was slightly alkaline in patients as compared to referents. The density of bile was found to be higher in patients as compared to the referents. Various functional groups present in different types of GS samples were confirmed by Fourier transform infra-red spectroscopy. The higher density and pH of bile, elevated concentrations of transition elements in all types of biological samples (serum, bile and GS), could be an important factor for the formation of different types of GS. Copyright © 2017 Elsevier B.V. All rights reserved.

  14. Serum Creatinine: Not So Simple!

    PubMed

    Delanaye, Pierre; Cavalier, Etienne; Pottel, Hans

    2017-01-01

    Measuring serum creatinine is cheap and commonly done in daily practice. However, interpretation of serum creatinine results is not always easy. In this review, we will briefly remind the physiological limitations of serum creatinine due notably to its tubular secretion and the influence of muscular mass or protein intake on its concentration. We mainly focus on the analytical limitations of serum creatinine, insisting on important concept such as reference intervals, standardization (and IDMS traceability), analytical interferences, analytical coefficient of variation (CV), biological CV and critical difference. Because the relationship between serum creatinine and glomerular filtration rate is hyperbolic, all these CVs will impact not only the precision of serum creatinine but still more the precision of different creatinine-based equations, especially in low or normal-low creatinine levels (or high or normal-high glomerular filtration rate range). © 2017 S. Karger AG, Basel.

  15. Hypocholesterolemic effect of stilbenes containing extract-fraction from Cajanus cajan L. on diet-induced hypercholesterolemia in mice.

    PubMed

    Luo, Qing-Feng; Sun, Lan; Si, Jian-Yong; Chen, Di-Hua

    2008-11-01

    Cajanus cajan (L) is a natural plant which contains a lot of potential active components. In the present study, we identified the effects of the stilbenes containing extract-fraction from Cajanus cajan L (sECC) on diet-induced (for 4 weeks) hypercholesterolemia in Kunming mice. All experimental mice were divided into 5 groups: control group, model group, sECC-treated with 200 or 100 mg/kg/day, and simvastatin group. The effects of sECC were investigated by monitoring serum and liver lipid profile (cholesterol homeostasis and triglyceride) as well as serum superoxide dismutase activity in those mice. To further explore the mechanism of sECC, hepatic 3-hydroxy-3-methylglutaryl-CoA reductase (HMG-CoA reductase), cholesterol 7α-hydroxylase (CYP7A1), and low density lipoprotein receptor (LDL receptor) expressions in cholesterol homeostasis were analyzed by reverse transcription PCR. After 4 weeks pretreatment, compared with model group, the increased serum and hepatic total cholesterol were markedly attenuated by sECC (200 mg/kg) by 31.4% and 22.7% (p<0.01), respectively, the triglyceride levels of serum and liver were also lowered by 22.98% and 14.39%, respectively. At the same time, serum LDL cholesterol decreased by 52.8% (p<0.01) accompanied with the activities of serum superoxide dismutase increased by 20.98%. Atherogenic index and body weight were also reduced markedly. The mRNA expressions of HMG-CoA reductase, CYP7A1, and LDL-receptor were significantly enhanced in the mice administered with sECC (200 mg/kg/day), whereas those expressions were suppressed by the hypercholesterolemic diet. These data indicate that sECC reduces the atherogenic properties of dietary cholesterol in mice. Its hypocholesterolemic effect may involve enhancement of the hepatic LDL-receptor and cholesterol 7alpha-hydroxylase expression levels and bile acid synthesis.

  16. [The selenium content of food products and the blood of inhabitants of Norilsk].

    PubMed

    Golubkina, N A; Shagova, M V; Spirichev, V B; Khristenko, P P; Alftan, D; Laaksonen, P; Muratov, Iu M; Vachaeva, N N

    1992-01-01

    The intake of trace element selenium by Norilsk citizens was assessed by its levels in the serum, food and soil. It was found that soil and food made in the Norilsk region are rich in selenium, its serum concentration in the population is normal (102 micrograms/l). References to such values for the Moscow and Zaporoje (Ukraine) regions are made. Low selenium levels in the serum may be indicative of pulmonary diseases.

  17. Effect of body temperature on chondroitinase ABC's ability to cleave chondroitin sulfate glycosaminoglycans.

    PubMed

    Tester, Nicole J; Plaas, Anna H; Howland, Dena R

    2007-04-01

    Chondroitinase ABC (Ch'ase ABC) is a bacterial lyase that degrades chondroitin sulfate (CS), dermatan sulfate, and hyaluronan glycosaminoglycans (GAGs). This enzyme has received significant attention as a potential therapy for promoting central nervous system and peripheral nervous system repair based on its degradation of CS GAGs. Determination of the stability of Ch'ase ABC activity at temperatures equivalent to normal (37 degrees C) and elevated (39 degrees C) body temperatures is important for optimizing its clinical usage. We report here data obtained from examining enzymatic activity at these temperatures across nine lots of commercially available protease-free Ch'ase ABC. CS GAG degrading activity was assayed by using 1) immunohistochemical detection of unsaturated disaccharide stubs generated by digestion of proteoglycans in tissue sections and 2) fluorophore-assisted carbohydrate electrophoresis (FACE) and/or high-performance liquid chromatography (HPLC) to separate and quantify unsaturated disaccharide digestion products. Our results indicate that there is a significant effect of lot and time on enzymatic thermostability. Average enzymatic activity is significantly decreased at 1 and 3 days at 39 degrees C and 37 degrees C, respectively. Furthermore, the average activity seen after 1 day was significantly different between the two temperatures. Addition of bovine serum albumin as a stabilizer significantly preserved enzymatic activity at 1 day, but not 3 days, at 39 degrees C. These results show that the CS GAG degrading activity of Ch'ase ABC is significantly decreased with incubation at body temperature over time and that all lots do not show equal thermostability. These findings are important for the design and interpretation of experimental and potential clinical studies involving Ch'ase ABC. (c) 2007 Wiley-Liss, Inc.

  18. Proteomic evaluation of sheep serum proteins

    PubMed Central

    2012-01-01

    Background The applications of proteomic strategies to ovine medicine remain limited. The definition of serum proteome may be a good tool to identify useful protein biomarkers for recognising sub-clinical conditions and overt disease in sheep. Findings from bovine species are often directly translated for use in ovine medicine. In order to characterize normal protein patterns and improve knowledge of molecular species-specific characteristics, we generated a two-dimensional reference map of sheep serum. The possible application of this approach was tested by analysing serum protein patterns in ewes with mild broncho-pulmonary disease, which is very common in sheep and in the peripartum period which is a stressful time, with a high incidence of infectious and parasitic diseases. Results This study generated the first reference 2-DE maps of sheep serum. Overall, 250 protein spots were analyzed, and 138 identified. Compared with healthy sheep, serum protein profiles of animals with rhino-tracheo-bronchitis showed a significant decrease in protein spots identified as transthyretin, apolipoprotein A1 and a significant increase in spots identified as haptoglobin, endopin 1b and alpha1B glycoprotein. In the peripartum period, haptoglobin, alpha-1-acid glycoprotein, apolipoprotein A1 levels rose, while transthyretin content dropped. Conclusions This study describes applications of proteomics in putative biomarker discovery for early diagnosis as well as for monitoring the physiological and metabolic situations critical for ovine welfare. PMID:22630135

  19. Serum copper, follicular stimulating hormone, luteinizing hormone, prolactin, spermatic count, viability, progression and seminal zinc correlations in a human (male) infertility study

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Sella, G.E.; Cunnane, S.C.; McInnes, R.A.

    1981-06-01

    The role of copper and its correlations to other parameters has been investigated in a male-fertility pilot study at a University infertility clinic in Montreal. Serum and semen Cu concentrations were determined in 100 men (age 25 to 54 years) referred to the clinic for infertility evaluation. The results of the significant correlations between serum Cu concentrations and male fertility parameters such as (1) the serum concentrations of the hormones FSH, LH and prolactin; (2) spermatozoal count, viability and progression and (3) seminal zinc concentrations are reported.

  20. Reprocessing Multiyear GPS Data from Continuously Operating Reference Stations on Cloud Computing Platform

    NASA Astrophysics Data System (ADS)

    Yoon, S.

    2016-12-01

    To define geodetic reference frame using GPS data collected by Continuously Operating Reference Stations (CORS) network, historical GPS data needs to be reprocessed regularly. Reprocessing GPS data collected by upto 2000 CORS sites for the last two decades requires a lot of computational resource. At National Geodetic Survey (NGS), there has been one completed reprocessing in 2011, and currently, the second reprocessing is undergoing. For the first reprocessing effort, in-house computing resource was utilized. In the current second reprocessing effort, outsourced cloud computing platform is being utilized. In this presentation, the outline of data processing strategy at NGS is described as well as the effort to parallelize the data processing procedure in order to maximize the benefit of the cloud computing. The time and cost savings realized by utilizing cloud computing approach will also be discussed.

  1. [Geographical distribution of the Serum creatinine reference values of healthy adults].

    PubMed

    Wei, De-Zhi; Ge, Miao; Wang, Cong-Xia; Lin, Qian-Yi; Li, Meng-Jiao; Li, Peng

    2016-11-20

    To explore the relationship between serum creatinine (Scr) reference values in healthy adults and geographic factors and provide evidence for establishing Scr reference values in different regions. We collected 29 697 Scr reference values from healthy adults measured by 347 medical facilities from 23 provinces, 4 municipalities and 5 autonomous regions. We chose 23 geographical factors and analyzed their correlation with Scr reference values to identify the factors correlated significantly with Scr reference values. According to the Principal component analysis and Ridge regression analysis, two predictive models were constructed and the optimal model was chosen after comparison of the two model's fitting degree of predicted results and measured results. The distribution map of Scr reference values was drawn using the Kriging interpolation method. Seven geographic factors, including latitude, annual sunshine duration, annual average temperature, annual average relative humidity, annual precipitation, annual temperature range and topsoil (silt) cation exchange capacity were found to correlate significantly with Scr reference values. The overall distribution of Scr reference values featured a pattern that the values were high in the south and low in the north, varying consistently with the latitude change. The data of the geographic factors in a given region allows the prediction of the Scr values in healthy adults. Analysis of these geographical factors can facilitate the determination of the reference values specific to a region to improve the accuracy for clinical diagnoses.

  2. Quality specifications for the extra-analytical phase of laboratory testing: Reference intervals and decision limits.

    PubMed

    Ceriotti, Ferruccio

    2017-07-01

    Reference intervals and decision limits are a critical part of the clinical laboratory report. The evaluation of their correct use represents a tool to verify the post analytical quality. Four elements are identified as indicators. 1. The use of decision limits for lipids and glycated hemoglobin. 2. The use, whenever possible, of common reference values. 3. The presence of gender-related reference intervals for at least the following common serum measurands (besides obviously the fertility relate hormones): alkaline phosphatase (ALP), alanine aminotransferase (ALT), creatine kinase (CK), creatinine, gamma-glutamyl transferase (GGT), IgM, ferritin, iron, transferrin, urate, red blood cells (RBC), hemoglobin (Hb) and hematocrit (Hct). 4. The presence of age-related reference intervals. The problem of specific reference intervals for elderly people is discussed, but their use is not recommended; on the contrary it is necessary the presence of pediatric age-related reference intervals at least for the following common serum measurands: ALP, amylase, creatinine, inorganic phosphate, lactate dehydrogenase, aspartate aminotransferase, urate, insulin like growth factor 1, white blood cells, RBC, Hb, Hct, alfa-fetoprotein and fertility related hormones. The lack of such reference intervals may imply significant risks for the patients. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  3. Improvement of antigen detection efficiency with the use of two-dimensional photonic crystal as a substrate

    NASA Astrophysics Data System (ADS)

    Dovzhenko, Dmitriy; Terekhin, Vladimir; Vokhmincev, Kirill; Sukhanova, Alyona; Nabiev, Igor

    2017-01-01

    Multiplex detection of different antigens in human serum in order to reveal diseases at the early stage is of interest nowadays. There are a lot of biosensors, which use the fluorescent labels for specific detection of analytes. For instance, common method for detection of antigens in human serum samples is enzyme-linked immunosorbent assay (ELISA). One of the most effective ways to improve the sensitivity of this detection method is the use of a substrate that could enhance the fluorescent signal and make it easier to collect. Two-dimensional (2D) photonic crystals are very suitable structures for these purposes because of the ability to enhance the luminescent signal, control the light propagation and perform the analysis directly on its surface. In our study we have calculated optimal parameters for 2D-dimensional photonic crystal consisting of the array of silicon nano-rods, fabricated such photonic crystal on a silicon substrate using reactive ion etching and showed the possibility of its efficient application as a substrate for ELISA detection of human cancer antigens.

  4. Differences in serum thyroglobulin measurements by 3 commercial immunoradiometric assay kits and laboratory standardization using Certified Reference Material 457 (CRM-457).

    PubMed

    Lee, Ji In; Kim, Ji Young; Choi, Joon Young; Kim, Hee Kyung; Jang, Hye Won; Hur, Kyu Yeon; Kim, Jae Hyeon; Kim, Kwang-Won; Chung, Jae Hoon; Kim, Sun Wook

    2010-09-01

    Serum thyroglobulin (Tg) is essential in the follow-up of patients with differentiated thyroid carcinoma (DTC). However, interchangeability and standardization between Tg assays have not yet been achieved, even with the development of an international Tg standard (Certified Reference Material 457 [CRM-457]). Serum Tg from 30 DTC patients and serially diluted CRM-457 were measured using 3 different immunoradiometric assays (IRMA-1, IRMA-2, IRMA-3). The intraclass correlation coefficient (ICC) method was used to describe the concordance of each IRMA to CRM-457. The serum Tg measured by 3 different IRMAs correlated well (r > .85, p < .0001), but clinically relevant discrepancies were found in 13.3% of patients. IRMA-3, which claims to be standardized to CRM-457, showed the best ICC (p(1) = .98) for the CRM-457. Hospitals caring for patients with DTC should either set their own cutoffs for IRMAs for Tg based on their patient pools, or adopt IRMAs standardized to CRM-457 and calibrate their laboratory using CRM-457.

  5. The Human Serum Metabolome

    PubMed Central

    Psychogios, Nikolaos; Hau, David D.; Peng, Jun; Guo, An Chi; Mandal, Rupasri; Bouatra, Souhaila; Sinelnikov, Igor; Krishnamurthy, Ramanarayan; Eisner, Roman; Gautam, Bijaya; Young, Nelson; Xia, Jianguo; Knox, Craig; Dong, Edison; Huang, Paul; Hollander, Zsuzsanna; Pedersen, Theresa L.; Smith, Steven R.; Bamforth, Fiona; Greiner, Russ; McManus, Bruce; Newman, John W.; Goodfriend, Theodore; Wishart, David S.

    2011-01-01

    Continuing improvements in analytical technology along with an increased interest in performing comprehensive, quantitative metabolic profiling, is leading to increased interest pressures within the metabolomics community to develop centralized metabolite reference resources for certain clinically important biofluids, such as cerebrospinal fluid, urine and blood. As part of an ongoing effort to systematically characterize the human metabolome through the Human Metabolome Project, we have undertaken the task of characterizing the human serum metabolome. In doing so, we have combined targeted and non-targeted NMR, GC-MS and LC-MS methods with computer-aided literature mining to identify and quantify a comprehensive, if not absolutely complete, set of metabolites commonly detected and quantified (with today's technology) in the human serum metabolome. Our use of multiple metabolomics platforms and technologies allowed us to substantially enhance the level of metabolome coverage while critically assessing the relative strengths and weaknesses of these platforms or technologies. Tables containing the complete set of 4229 confirmed and highly probable human serum compounds, their concentrations, related literature references and links to their known disease associations are freely available at http://www.serummetabolome.ca. PMID:21359215

  6. Evaluation of the nutritional equivalency of soybean meal with the genetically modified trait DP-3O5423-1 when fed to laying hens.

    PubMed

    Mejia, L; Jacobs, C M; Utterback, P L; Parsons, C M; Rice, D; Sanders, C; Smith, B; Iiams, C; Sauber, T

    2010-12-01

    An experiment using 336 Hy-Line W-36 Single Comb White Leghorn hens was conducted to evaluate transgenic soybeans containing the gm-fad2-1 gene fragment and the gm-hra gene. Transcription of the gm-fad2-1 gene fragment results in an increased level of oleic acid (18:1) in the seed, and expression of the soybean acetolactate synthase protein (GM-HRA) encoded by the modified gm-hra gene, is used as a selectable marker during transformation. Pullets (20 wk of age) were placed in cage lots (7 hens/cage, 2 cages/lot) and were randomly assigned to 1 of 4 corn-soybean meal dietary treatments (6 lots/treatment) formulated with the following soybean meals: nontransgenic near-isoline control (control), nontransgenic commercial reference soybean meal A (92M72), nontransgenic commercial reference soybean meal B (93B15), or transgenic soybean meal produced from soybeans containing event DP-3Ø5423-1 (305423). Weeks 20 to 24 were a preconditioning period, and the 4 experimental diets were then fed from 25 to 36 wk of age. Differences between the 305423 and control group means were evaluated, with statistical significance at P < 0.05. Body weight, hen-day egg production, egg mass, feed consumption, and feed efficiency for hens fed the 305423 soybean meal were not significantly different from the respective values for hens fed diets formulated with the near-isoline soybean meal. Likewise, egg component weights, Haugh unit measures, and egg weights were similar regardless of the soybean meal source. This research indicates that performance of hens fed diets containing 305423 soybean meal, as measured by egg production and egg quality, was similar to that of hens fed diets formulated with the near-isoline control and commercial soybean meals.

  7. Choice of Reference Serum Creatinine in Defining Acute Kidney Injury.

    PubMed

    Siew, Edward D; Matheny, Michael E

    2015-01-01

    The study of acute kidney injury (AKI) has expanded with the increasing availability of electronic health records and the use of standardized definitions. Understanding the impact of AKI between settings is limited by heterogeneity in the selection of reference creatinine to anchor the definition of AKI. In this mini-review, we discuss different approaches used to select reference creatinine and their relative merits and limitations. We reviewed the literature to obtain representative examples of published baseline creatinine definitions when pre-hospital data were not available, as well as literature evaluating the estimation of baseline renal function, using PubMed and reference back-tracing within known works. (1) Pre-hospital creatinine values are useful in determining reference creatinine, and in high-risk populations, the mean outpatient serum creatinine value 7-365 days before hospitalization closely approximates nephrology adjudication, (2) in patients without pre-hospital data, the eGFR 75 approach does not reliably estimate true AKI incidence in most at-risk populations, (3) using the lowest inpatient serum creatinine may be reasonable, especially in those with preserved kidney function, but may generously estimate AKI incidence and severity and miss community-acquired AKI that does not fully resolve, (4) using more specific definitions of AKI (e.g., KIDGO stages 2 and 3) may help to reduce the effects of misclassification when using surrogate values and (5) leveraging available clinical data may help refine the estimate of reference creatinine. Choosing reference creatinine for AKI calculation is important for AKI classification and study interpretation. We recommend obtaining data on pre-hospital kidney function, wherever possible. In studies where surrogate estimates are used, transparency in how they are applied and discussion that informs the reader of potential biases should be provided. Further work to refine the estimation of reference creatinine is needed. © 2015 S. Karger AG, Basel.

  8. Serum phosphate and cognitive function in older men.

    PubMed

    Slinin, Yelena; Vo, Tien; Taylor, Brent C; Murray, Anne M; Schousboe, John; Langsetmo, Lisa; Ensrud, Kristine

    2018-01-01

    Determine whether serum phosphate is associated with concurrent cognitive impairment and subsequent cognitive decline in older men independent of demographic covariates and atherosclerotic risk factors. In a prospective study of 5529 men enrolled in the Osteoporotic Fractures in Men study, we measured baseline serum phosphate, baseline cognitive function, and change in cognitive function between baseline and follow-up exams an average of 4.6 years later using the Modified Mini-Mental State (3MS) Examination and Trails B. There was no association between serum phosphate and odds of cognitive impairment as assessed by baseline 3MS score or risk of cognitive decline as assessed by longitudinal change in 3MS score. Higher baseline serum phosphate was associated with higher odds of poor executive function as assessed by Trails B with fully adjusted odds ratios 1.12 (95% confidence interval: 0.83-1.52), 1.31 (0.97-1.77), and 1.45 (1.08-1.94) for men in the second, third, and fourth versus the bottom quartile (referent group) of serum phosphate (p-trend 0.007). However, higher phosphate level was not associated with risk of decline in executive function as assessed by longitudinal change in Trails B score with fully adjusted odds ratios 0.94 (95% confidence interval 0.69-1.28), 0.96 (0.70-1.32), and 1.21 (0.89-1.66) for men in the second, third, and fourth versus the bottom quartile (referent group) of serum phosphate (p-trend 0.22). Higher serum phosphate in older men was associated with a higher likelihood of poor executive function, but not with impaired global cognitive function or decline in executive or global cognition. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  9. Vitamin D and Sunlight Exposure in Newly-Diagnosed Parkinson's Disease.

    PubMed

    Wang, Juan; Yang, Deyu; Yu, Yu; Shao, Gaohai; Wang, Qunbo

    2016-03-04

    Circulating vitamin D has previously been found to be lower in patients with Parkinson's disease (PD), while the effects of sunlight exposure have not yet been fully investigated. Therefore, we evaluated the associations between serum vitamin D, vitamin D intake, sunlight exposure, and newly-diagnosed PD patients in a Chinese population. This case-control study measured serum 25-hydroxyvitamin D (25(OH)D) levels and sunlight exposure in 201 patients with newly-diagnosed PD and 199 controls without neurodegenerative diseases. Data on vitamin D intake and sunlight exposure were obtained using a self-report questionnaire. Multivariable logistic regressions were employed to evaluate the associations between serum 25(OH)D levels, sunlight exposure, and PD. Adjustments were made for sex, age, smoking, alcohol use, education, BMI, and vitamin D intake. There were significantly lower levels of serum 25(OH)D (20.6 ± 6.5 ng/mL), daily vitamin D intake (8.3 ± 3.7 g/day), and sunlight exposure (9.7 ± 4.1 h/week) in patients with PD compared to healthy controls (p < 0.05). Crude odds ratios (ORs) for PD in the quartiles of serum 25(OH)D were 1 (reference), 0.710 (0.401, 1.257), 0.631 (0.348, 1.209), and 0.483 (0.267, 0.874), respectively. Crude ORs for PD in quartiles of sunlight exposure were 1 (reference), 0.809 (0.454, 1.443), 0.623 (0.345, 1.124) and 0.533 (0.294, 0.966), respectively. A significant positive correlation between serum 25(OH)D and sunlight exposure was found, but serum 25(OH)D was not correlated with daily vitamin D intake. This study indicates that lower levels of serum 25(OH)D and sunlight exposure are significantly associated with an increased risk for PD.

  10. Evaluation of a tunable bandpass reaction cell inductively coupled plasma mass spectrometer for the determination of selenium in serum and urine

    NASA Astrophysics Data System (ADS)

    Nixon, David E.; Neubauer, Kenneth R.; Eckdahl, Steven J.; Butz, John A.; Burritt, Mary F.

    2003-01-01

    A Dynamic Reaction Cell™ inductively coupled plasma mass spectrometer (DRC-ICP-MS) was evaluated for the determination of selenium in serum and urine. Reaction cell conditions were evaluated for the suppression of Ar 2+ dimer at m/ z 78 and 80 using methane as the reaction gas. A diluent containing 10% ethanol, 1% nitric acid, 0.5% Triton X-100 with gallium and yttrium internal standards was used to dilute urine and serum samples. Instrument response calibration was achieved by using aqueous acidic standards spiked into a urine matrix. Slopes for aqueous inorganic selenium, seleno- DL-cystine, seleno- DL-methionine and trimethylselenonium iodide spiked into urine and serum matrices were nearly identical. In general, reagent blank readings and detection limits were significantly lower in the DRC mode (reaction cell pressurized) than the standard mode (cell vented). Average results for the analysis of National Institute of Standards and Technology Standard Reference Material (NIST SRM) 1598 bovine serum (attained over 13 days) are: 43.8±3.6 μg Se/l. Reference concentration is 43.6±3.6 μg Se/l. For NIST SRM 2670 Normal Urine the DRC-ICP-MS results are 30.7±4.6 μg Se/l with a certified concentration of 30±8 μg Se/l. For NIST SRM 2670 Elevated Urine the DRC-ICP-MS results are 463±35 μg Se/l with a certified concentration of 460±30 μg Se/l. The DRC-ICP-MS results for selenium determinations in urine and serum survey samples from the Institut National de Sante Publique du Quebec were compared with the reference concentrations and results produced by conventional ICP-MS. While conventional ICP-MS gave acceptable results for survey samples, DRC-ICP-MS gave excellent results for both urine and sera. Closer correlation was observed for DRC-ICP-MS results with target concentrations than with conventional ICP-MS.

  11. Development of a 100 nmol mol(-1) propane-in-air SRM for automobile-exhaust testing for new low-emission requirements.

    PubMed

    Rhoderick, George C

    2007-04-01

    New US federal low-level automobile emission requirements, for example zero-level-emission vehicle (ZLEV), for hydrocarbons and other species, have resulted in the need by manufacturers for new certified reference materials. The new emission requirement for hydrocarbons requires the use, by automobile manufacturing testing facilities, of a 100 nmol mol(-1) propane in air gas standard. Emission-measurement instruments are required, by federal law, to be calibrated with National Institute of Standards and Technology (NIST) traceable reference materials. Because a NIST standard reference material (SRM) containing 100 nmol mol(-1) propane was not available, the US Environmental Protection Agency (EPA) and the Automobile Industry/Government Emissions Research Consortium (AIGER) requested that NIST develop such an SRM. A cylinder lot of 30 gas mixtures containing 100 nmol mol(-1) propane in air was prepared in 6-L aluminium gas cylinders by a specialty gas company and delivered to the Gas Metrology Group at NIST. Another mixture, contained in a 30-L aluminium cylinder and included in the lot, was used as a lot standard (LS). Using gas chromatography with flame-ionization detection all 30 samples were compared to the LS to obtain the average of six peak-area ratios to the LS for each sample with standard deviations of <0.31%. The average sample-to-LS ratio determinations resulted in a range of 0.9828 to 0.9888, a spread of 0.0060, which corresponds to a relative standard deviation of 0.15% of the average for all 30 samples. NIST developed its first set of five propane in air primary gravimetric standards covering a concentration range 91 to 103 nmol mol(-1) with relative uncertainties of 0.15%. This new suite of propane gravimetric standards was used to analyze and assign a concentration value to the SRM LS. On the basis of these data each SRM sample was individually certified, furnishing the desired relative expanded uncertainty of +/-0.5%. Because automobile companies use total hydrocarbons to make their measurements, it was also vital to assign a methane concentration to the SRM samples. Some of the SRM samples were analyzed and found to contain 1.2 nmol mol(-1) methane. Twenty-five of the samples were certified and released as SRM 2765.

  12. Determination of element levels in human serum: Total reflection X-ray fluorescence applications

    NASA Astrophysics Data System (ADS)

    Majewska, U.; Łyżwa, P.; Łyżwa, K.; Banaś, D.; Kubala-Kukuś, A.; Wudarczyk-Moćko, J.; Stabrawa, I.; Braziewicz, J.; Pajek, M.; Antczak, G.; Borkowska, B.; Góźdź, S.

    2016-08-01

    Deficiency or excess of elements could disrupt proper functioning of the human body and could lead to several disorders. Determination of their concentrations in different biological human fluids and tissues should become a routine practice in medical treatment. Therefore the knowledge about appropriate element concentrations in human organism is required. The purpose of this study was to determine the concentration of several elements (P, S, Cl, K, Ca, Cr, Fe, Cu, Zn, Se, Br, Rb, Pb) in human serum and to define the reference values of element concentration. Samples of serum were obtained from 105 normal presumably healthy volunteers (66 women aged between 15 and 78 years old; 39 men aged between 15 and 77 years old). Analysis has been done for the whole studied population and for subgroups by sex and age. It is probably first so a wide study of elemental composition of serum performed in the case of Świętokrzyskie region. Total reflection X-ray fluorescence (TXRF) method was used to perform the elemental analysis. Spectrometer S2 Picofox (Bruker AXS Microanalysis GmbH) was used to identify and measure elemental composition of serum samples. Finally, 1st and 3rd quartiles were accepted as minimum and maximum values of concentration reference range.

  13. Reference values for serum levels of insulin-like growth factor 1 (IGF-1) and IGF-binding protein 3 (IGFBP-3) in the West Black Sea region of Turkey.

    PubMed

    Guven, Berrak; Can, Murat; Mungan, Gorkem; Acіkgoz, Serefden

    2013-03-01

    The aim of this study was to determine the normal values of serum IGF-1 and IGFBP-3 in Turkish children and adults (1-79 years). The study included 571 healthy children and 625 healthy adults from the West Black Sea region of Turkey. Serum IGF-1 and IGFBP-3 concentrations were determined using a chemiluminescent immunometric assay on an Immulite 1000 analyzer. IGF-1 and IGFBP-3 levels tended to be higher in girls compared to boys among the children. The differences were statistically significant in puberty from age 12-14 years for IGF-1 and prepubertally from age 9-10 years for IGFBP-3. Peaks of serum IGF-1 levels were observed 2 years earlier in girls (14 years) than boys (16 years). The general pattern of IGFBP-3 was similar to IGF-1 during puberty. In adults, IGF-1 and IGFBP-3 levels decreased by age. There was no significant difference in IGF-1 and IGFBP3 values between men and women in any age group. This study established age- and sex-specific reference values for serum IGF-1 and IGFBP-3 in healthy Turkish children and adults.

  14. Persistent low levels of serum hCG due to heterophilic mouse antibodies: an unrecognized pitfall in the diagnosis of trophoblastic disease.

    PubMed

    González Aguilera, B; Syrios, P; Gadisseur, R; Luyckx, F; Cavalier, E; Beckers, A; Valdes-Socin, H

    2016-06-01

    Phantom hCG refers to persistent mild elevations of hCG, leading physicians to unnecessary treatments whereas neither a true hCG nor a trophoblastic disease is present. We report the case of a 23-year-old woman with persistent low levels of serum hCG detected one month after miscarriage. As choriocarcinoma was suspected, a chemotherapy trial of methotrexate was prescribed, without any hCG reduction. Subsequently, laparoscopy ruled out a trophoblastic residue and the patient was referred to the Endocrine Unit for further investigations. While low levels of hCG were still detected in serum, no hCG was detected in the urine. In addition, when serum was processed in a HBT tube for revealing heterophilic antibodies, hCG was no longer detected. Such finding indicated the presence of phantom hCG due to heterophilic mouse antibodies interaction. This case raises the need of clinico-biological discussion to avoid inappropriate therapeutic decisions. Based on this case experience and after review of the literature, we suggest that current gynecological protocols for the diagnosis and treatment of trophoblastic disease should consider the inclusion of urinary hCG and/or a test for serum heterophilic antibodies when appropriate.

  15. Hypothyroidism in dogs: 66 cases (1987-1992).

    PubMed

    Panciera, D L

    1994-03-01

    Sixty-six dogs with hypothyroidism were identified from dogs examined over a 5-year period. Hypothyroidism was diagnosed only if the dog had a low, resting serum thyroxine concentration and serum thyroxine concentration was not higher than the lower limits of the reference range 6 hours after IV administration of bovine thyrotropin. The prevalence of hypothyroidism was 0.2%. Neutering was determined to be the most significant gender-associated risk factor for development of hypothyroidism. Neutered male and spayed female dogs had a higher relative risk of developing hypothyroidism than did sexually intact females. Sexually intact females had a lower relative risk. Breeds with a significantly increased risk, compared with other breeds, were the Doberman Pinscher and Golden Retriever. The most common clinical findings were obesity (41%), seborrhea (39%), alopecia (26%), weakness (21%), lethargy (20%), bradycardia (14%), and pyoderma (11%). Low voltage R-waves were found on 58% of ECG. Clinicopathologic abnormalities included hypercholesterolemia (73%), nonregenerative anemia (32%), high serum alkaline phosphatase activity (30%), and high serum creatine kinase activity (18%). Serum total triiodothyronine concentrations were within reference ranges in 15% of the hypothyroid dogs. Response to treatment was good in most dogs, but those with severe concurrent disease or neurologic abnormalities were less likely to respond with complete resolution of clinical signs.

  16. Minor changes in serum levels of cytokines after removal of amalgam restorations.

    PubMed

    Björkman, Lars; Brokstad, Karl A; Moen, Ketil; Jonsson, Roland

    2012-06-01

    Dental amalgam restorations release mercury and silver which is absorbed and distributed in the body. Animal studies have shown that both elements may interfere with the host by activation of the immune system in genetically susceptible strains at exposure levels relevant to those from dental amalgam restorations. The aim of this study was to test the hypothesis of no change over time in concentrations of a number of immune mediators in serum after removal of all dental amalgam restorations in patients with health complaints attributed to their amalgam restorations and compare with a healthy reference group. Twenty patients previously examined at a specialty unit for health complaints attributed to dental materials were included in a clinical trial and had all amalgam restorations replaced with other dental restorative materials. Serum samples were collected before amalgam removal and 3 and 12 months after the removal was finished. Twenty blood donors matched for age and gender were used as comparison group. A fluorescent bead-based (Luminex) immunoassay kit was used to measure cytokines, chemokines and growth factors in serum. At baseline, the patient group had slightly higher values for GM-CSF, IL-6, IL-2R, IFN-alpha, IL-7, and IL-12p40/p70 compared with the reference group. After amalgam removal a decrease towards the median value of the reference group was found for GM-CSF, IL-8, and IL-7. In conclusion, removal of all dental amalgam restorations and replacement with other dental restorative materials was associated with decreased concentrations of Th1-type proinflammatory markers in serum. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  17. Diagnostic reference range of κ/λ free light chain ratio to screen for Bence Jones proteinuria is not significantly influenced by GFR.

    PubMed

    Schmidt-Hieltjes, Yvonne; Elshof, Clemens; Roovers, Lian; Ruinemans-Koerts, Janneke

    2016-05-01

    The aim of our study was to analyse whether the κ/λ free light chain ratio reference range for screening for Bence Jones proteinuria should be dependent on the estimated glomerular filtration rate (eGFR). The serum κ/λ free light chain ratio, eGFR, serum M-protein and Bence Jones protein were measured in 544 patients for whom Bence Jones protein analysis was ordered. In the population of patients without Bence Jones proteinuria or a M-protein (n = 402), there is no gradual increase in κ/λ free light chain ratio with diminishing eGFR. The κ/λ free light chain ratio in this group was 0.56-1.86 (95% interval). With this diagnostic reference range of the κ/λ ratio, 105 of the 110 patients with Bence Jones protein could be identified correctly. Only five patients with Bence Jones proteinuria (<0.17 g/L) were missed, without diagnostic or therapeutic consequences. In 36 patients (6.6%), an abnormal κ/λ free light chain ratio was measured without the presence of Bence Jones proteinuria. A κ/λ free light chain ratio in serum can be used safely and efficiently to select urine samples which should be analysed for Bence Jones proteinuria with an electrophoresis/immunofixation technique. Using this diagnostic reference range, the number of urine samples which should be analysed by electrophoresis/immunofixation could be reduced by 74%. The diagnostic reference interval can be determined best in a group of patients for whom Bence Jones analysis is indicated. For calculation of this reference range, the eGFR value does not need to be taken into account. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  18. Establishing pediatric reference intervals for 13 biochemical analytes derived from normal subjects in a pediatric endocrinology clinic in Korea.

    PubMed

    Cho, Sun-Mi; Lee, Sang-Guk; Kim, Ho Seong; Kim, Jeong-Ho

    2014-12-01

    Defining pediatric reference intervals is one of the most difficult tasks for laboratory physicians. The continuously changing physiology of growing children makes their laboratory values moving targets. In addition, ethnic and behavioral differences might also cause variations. The aim of this study was to establish age- and sex-specific partitioned reference intervals for 13 serum biochemical analytes in Korean children. A total of 2474 patients, girls aged 2-14 years and boys aged 2-16 years, who underwent a short stature workup but were diagnosed as normal at the Pediatric Endocrinology Clinic of Severance Hospital (Seoul, Korea) between September 2010 and June 2012 were included in this study. The levels of serum calcium, inorganic phosphorus, blood urea nitrogen, creatinine, uric acid, glucose, total cholesterol, total protein, albumin, alkaline phosphatase, aspartic aminotransferase, alanine aminotransferase, and total bilirubin were measured using a Hitachi 7600 analyzer (Hitachi High-Technologies Corporation, Tokyo, Japan). Reference intervals were partitioned according to sex or age subgroups using the Harris and Boyd method. Most analytes except calcium and albumin required partitioning either by sex or age. Age-specific partitioned reference intervals for alkaline phosphatase, creatinine, and total bilirubin were established for both males and females after being partitioned by sex. Additional age-specific partitioning of aspartic aminotransferase in females and total protein and uric acid in males was also required. Inorganic phosphorus, total cholesterol, alanine aminotransferase, blood urea nitrogen, and glucose were partitioned only by sex. This study provided updated age- and sex-specific pediatric reference intervals for 13 basic serum chemistry analytes from a sufficient number of healthy children by using a modern analytical chemistry platform. Copyright © 2014 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  19. Thyroid Stimulating Hormone Reference Range and Prevalence of Thyroid Dysfunction in the Korean Population: Korea National Health and Nutrition Examination Survey 2013 to 2015

    PubMed Central

    2017-01-01

    Background No nationwide epidemiological study evaluating the prevalence of subclinical and overt forms of hypothyroidism and hyperthyroidism has yet been conducted in Korea. This study aimed to evaluate the reference range of serum thyroid stimulating hormone (TSH) and the national prevalence of thyroid dysfunctions in Korea. Methods Nation-wide cross-sectional data were analyzed from a representative sample of the civilian, non-institutionalized Korean population (n=6,564) who underwent blood testing for thyroid function and anti-thyroid peroxidase antibody (TPOAb) as part of the Korea National Health and Nutrition Examination Survey VI (2013 to 2015). Results The reference interval of serum TSH in the Korean reference population was 0.62 to 6.68 mIU/L. Based on this reference interval, the prevalence of overt and subclinical hypothyroidism was 0.73% (males 0.40%, females 1.10%) and 3.10% (males 2.26%, females 4.04%), respectively. The prevalence of hypothyroidism increased with age until the age group between 50 to 59 years. Positive TPOAb were found in 7.30% of subjects (males 4.33%, females 10.62%). The prevalence of overt and subclinical hypothyroidism TPOAb-positive subjects was 5.16% and 10.88%, respectively. The prevalence of overt and subclinical hyperthyroidism was 0.54% (males 0.30%, females 0.81%) and 2.98% (males 2.43%, females, 3.59%), respectively. Conclusion The Serum TSH reference levels in the Korean population were higher than the corresponding levels in Western countries. Differences were found in the prevalence of hypothyroidism and hyperthyroidism according to age, sex, and TPOAb positivity. This study provides important baseline information for understanding patterns of thyroid dysfunction and diseases in Korea. PMID:28116874

  20. Optimized angiotensin-converting enzyme activity assay for the accurate diagnosis of sarcoidosis.

    PubMed

    Csongrádi, Alexandra; Enyedi, Attila; Takács, István; Végh, Tamás; Mányiné, Ivetta S; Pólik, Zsófia; Altorjay, István Tibor; Balla, József; Balla, György; Édes, István; Kappelmayer, János; Tóth, Attila; Papp, Zoltán; Fagyas, Miklós

    2018-06-27

    Serum angiotensin-converting enzyme (ACE) activity determination can aid the early diagnosis of sarcoidosis. We aimed to optimize a fluorescent kinetic assay for ACE activity by screening the confounding effects of endogenous ACE inhibitors and interfering factors. Genotype-dependent and genotype-independent reference values of ACE activity were established, and their diagnostic accuracies were validated in a clinical study. Internally quenched fluorescent substrate, Abz-FRK(Dnp)P-OH was used for ACE-activity measurements. A total of 201 healthy individuals and 59 presumably sarcoidotic patients were enrolled into this study. ACE activity and insertion/deletion (I/D) genotype of the ACE gene were determined. Here we report that serum samples should be diluted at least 35-fold to eliminate the endogenous inhibitor effect of albumin. No significant interferences were detected: up to a triglyceride concentration of 16 mM, a hemoglobin concentration of 0.71 g/L and a bilirubin concentration of 150 μM. Genotype-dependent reference intervals were considered as 3.76-11.25 U/L, 5.22-11.59 U/L, 7.19-14.84 U/L for II, ID and DD genotypes, respectively. I/D genotype-independent reference interval was established as 4.85-13.79 U/L. An ACE activity value was considered positive for sarcoidosis when it exceeded the upper limit of the reference interval. The optimized assay with genotype-dependent reference ranges resulted in 42.5% sensitivity, 100% specificity, 100% positive predictive value and 32.4% negative predictive value in the clinical study, whereas the genotype-independent reference range proved to have inferior diagnostic efficiency. An optimized fluorescent kinetic assay of serum ACE activity combined with ACE I/D genotype determination is an alternative to invasive biopsy for confirming the diagnosis of sarcoidosis in a significant percentage of patients.

  1. [Clinical evaluation of a novel HBsAg quantitative assay].

    PubMed

    Takagi, Kazumi; Tanaka, Yasuhito; Naganuma, Hatsue; Hiramatsu, Kumiko; Iida, Takayasu; Takasaka, Yoshimitsu; Mizokami, Masashi

    2007-07-01

    The clinical implication of the hepatitis B surface antigen (HBsAg) concentrations in HBV-infected individuals remains unclear. The aim of this study was to evaluate a novel fully automated Chemiluminescence Enzyme Immunoassay (Sysmex HBsAg quantitative assay) by comparative measurements of the reference serum samples versus two independent commercial assays (Lumipulse f or Architect HBsAg QT). Furthermore, clinical usefulness was assessed for monitoring of the serum HBsAg levels during antiviral therapy. A dilution test using 5 reference-serum samples showed linear correlation curve in range from 0.03 to 2,360 IU/ml. The HBsAg was measured in total of 400 serum samples and 99.8% had consistent results between Sysmex and Lumipulse f. Additionally, a positive linear correlation was observed between Sysmex and Architect. To compare the Architect and Sysmex, both methods were applied to quantify the HBsAg in serum samples with different HBV genotypes/subgenotypes, as well as in serum contained HBV vaccine escape mutants (126S, 145R). Correlation between the methods was observed in results for escape mutants and common genotypes (A, B, C) in Japan. Observed during lamivudine therapy, an increase in HBsAg and HBV DNA concentrations preceded the aminotransferase (ALT) elevation associated with drug-resistant HBV variant emergence (breakthrough hepatitis). In conclusion, reliability of the Sysmex HBsAg quantitative assay was confirmed for all HBV genetic variants common in Japan. Monitoring of serum HBsAg concentrations in addition to HBV DNA quantification, is helpful in evaluation of the response to lamivudine treatment and diagnosis of the breakthrough hepatitis.

  2. Deceiving proteins! A case of lymphoma and high creatinine.

    PubMed

    Metraiah, El Hakem Abdelkarim; Regan, Helen; Louw, Johanna; Kidder, Dana

    2017-01-23

    Estimation of kidney function by measuring serum creatinine is one the commonest laboratory tests conducted in clinical practice. Enzymatic methods are often used to measure serum creatinine. Clinicians should be aware of the limitations of these methods, such as test interference with paraproteins.We present a case of falsely elevated serum creatinine in a patient referred for renal biopsy. The combination of fluctuating creatinine and normal blood urea level was unusual. Serum protein electrophoresis revealed the presence of an IgM paraprotein. Further investigations confirmed an underlying diagnosis of lymphoplasmacytoid lymphoma. This case highlights how IgM paraprotein can interfere with creatinine estimation by enzymatic assay and the utility of alternative methods of estimating serum creatinine. 2017 BMJ Publishing Group Ltd.

  3. Assessment of tolerant sunfish populations (Lepomis sp.) inhabiting selenium-laden coal ash effluents. 3. Serum chemistry and fish health indicators.

    PubMed

    Lohner, T W; Reash, R J; Willet, V E; Fletcher, J

    2001-11-01

    Sunfish were collected from fly ash discharge-receiving streams to assess the possible effects of exposure to elevated selenium. Concentrations of selenium, copper, and arsenic were statistically higher in fish tissue (liver) samples from effluent-exposed fish than in reference fish. Several biomarkers were indicative of metal exposure and effect. Plasma protein levels and cholesterol levels were significantly lower in exposed fish, indicating nutritional stress. Ion levels (i.e., K) increased with exposure to ash pond metals, indicating possible gill damage. Fish from the receiving streams also had increased serum glucose and osmolality indicating possible acute stress due to sampling. Fish health assessments revealed a lower incidence of fin erosion, kidney discoloration, urolithiasis or nephrocalcinosis, liver discoloration, and parasites in exposed fish and a higher incidence of skin, eye, and gill aberrations. Condition factors of exposed fish were correlated with biomarker response and were the same as or lower than those of reference fish, but not related to selenium levels. Although several serum biochemical indicators differed between the ash pond-receiving stream and reference sites, pollutant exposure was apparently not sufficient to cause functional damage to critical organ systems.

  4. Clinical and Biochemical Correlates of Serum L-Ergothioneine Concentrations in Community-Dwelling Middle-Aged and Older Adults

    PubMed Central

    Sotgia, Salvatore; Zinellu, Angelo; Mangoni, Arduino A.; Pintus, Gianfranco; Attia, John; Carru, Ciriaco; McEvoy, Mark

    2014-01-01

    Background Despite the increasing interest towards the biological role of L-ergothioneine, little is known about the serum concentrations of this unusual aminothiol in older adults. We addressed this issue in a representative sample of community-dwelling middle-aged and older adults. Methods Body mass index, estimated glomerular filtration rate, serum concentrations of L-ergothioneine, taurine, homocysteine, cysteine, glutathione, cysteinylglycine, and glutamylcysteine were evaluated in 439 subjects (age 55–85 years) randomly selected from the Hunter Community Study. Results Median L-ergothioneine concentration in the entire cohort was 1.01 IQR 0.78–1.33 µmol/L. Concentrations were not affected by gender (P = 0.41) or by presence of chronic medical conditions (P = 0.15). By considering only healthy subjects, we defined a reference interval for L-ergothioneine serum concentrations from 0.36 (90% CI 0.31–0.44) to 3.08 (90% CI 2.45–3.76) µmol/L. Using stepwise multiple linear regression analysis L-ergothioneine was negatively correlated with age (rpartial = −0.15; P = 0.0018) and with glutamylcysteine concentrations (rpartial = −0.13; P = 0.0063). Conclusions A thorough analysis of serum L-ergothioneine concentrations was performed in a large group of community-dwelling middle-aged and older adults. Reference intervals were established. Age and glutamylcysteine were independently negatively associated with L-ergothioneine serum concentration. PMID:24392160

  5. A traceable reference for direct comparative assessment of total naphthenic acid concentrations in commercial and acid extractable organic mixtures derived from oil sands process water.

    PubMed

    Brunswick, Pamela; Hewitt, L Mark; Frank, Richard A; Kim, Marcus; van Aggelen, Graham; Shang, Dayue

    2017-02-23

    The advantage of using naphthenic acid (NA) mixtures for the determination of total NA lies in their chemical characteristics and identification of retention times distinct from isobaric interferences. However, the differing homolog profiles and unknown chemical structures of NA mixtures do not allow them to be considered a traceable reference material. The current study provides a new tool for the comparative assessment of different NA mixtures by direct reference to a single, well-defined and traceable compound, decanoic-d 19 acid. The method employed an established liquid chromatography time-of-flight mass spectrometry (LC/QToF) procedure that was applicable both to the classic O2 NA species dominating commercial mixtures and additionally to the O4 species known to be present in acid extractable organics (AEOs) derived from oil sands process water (OSPW). Four different commercial NA mixtures and one OSPW-derived AEOs mixture were comparatively assessed. Results showed significant difference among Merichem Technical, Aldrich, Acros, and Kodak commercial NA mixtures with respect to "equivalent to decanoic-d 19 acid" concentration ratios to nominal. Furthermore, different lot numbers of single commercial NA mixtures were found to be inconsistent with respect to their homolog content by percent response. Differences in the observed homolog content varied significantly, particularly at the lower (n = 9-14) and higher (n = 20-23) carbon number ranges. Results highlighted the problem between using NA mixtures from different sources and different lot numbers but offered a solution to the problem from a concentration perspective. It is anticipated that this tool may be utilized in review of historical data in addition to future studies, such as the study of OSPW derived acid extractable organics (AEOs) and fractions employed during toxicological studies.

  6. Falls relate to vitamin D and parathyroid hormone in an Australian nursing home and hostel.

    PubMed

    Stein, M S; Wark, J D; Scherer, S C; Walton, S L; Chick, P; Di Carlantonio, M; Zajac, J D; Flicker, L

    1999-10-01

    To determine whether falling relates to serum levels of vitamin D and parathyroid hormone. A cross-sectional study with retrospective analysis. An aged-care institution in Melbourne Australia. Ambulant nursing home and hostel residents (n = 83). Frequency of falling, frequency of going outdoors, use of cane or walker, age, sex, weight, type of accommodation, and duration of residence. Serum concentrations of 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D, and parathyroid hormone (PTH). Plasma concentrations of albumin, calcium, phosphate, and creatinine. Use of furosemide or non-benzodiazepine anticonvulsants. Median age of residents was 84 years. The cohort was vitamin D deficient with a median (interquartile range) 25-hydroxyvitamin D level of 27 (18-37) nmol/L (one-third the reference range median), P < .001. The median (interquartile range) PTH of 5.2 (3.8-7.7) pmol/L exceeded the reference range median, P < .001. Residents who fell (n = 33) had lower serum 25-hydroxyvitamin D levels than other residents (medians 22 vs 29 nmol/L, P = .02) and higher serum PTH levels (medians 6.2 vs 4.8 pmol/L, P < .01). Sixty residents lived in the hostel (72%), and 41 (49%) walked without any walking aid. In a multiple logistic regression for falling, higher serum PTH remained independently associated with falling, with an odds ratio (95% confidence interval) for falling of 5.6 (1.7-18.5) per unit of the natural logarithm of serum PTH. Other terms in the regression were hostel accommodation, odds ratio .04 (.01-.25), and ability to walk without aids, odds ratio .07 (.01-.37). In ambulant nursing home and hostel residents, residents who fall have lower serum 25-hydroxyvitamin D and higher serum parathyroid hormone levels than other residents. The association between falling and serum PTH persists after adjustment for other variables.

  7. Estimating degradation in real time and accelerated stability tests with random lot-to-lot variation: a simulation study.

    PubMed

    Magari, Robert T

    2002-03-01

    The effect of different lot-to-lot variability levels on the prediction of stability are studied based on two statistical models for estimating degradation in real time and accelerated stability tests. Lot-to-lot variability is considered as random in both models, and is attributed to two sources-variability at time zero, and variability of degradation rate. Real-time stability tests are modeled as a function of time while accelerated stability tests as a function of time and temperatures. Several data sets were simulated, and a maximum likelihood approach was used for estimation. The 95% confidence intervals for the degradation rate depend on the amount of lot-to-lot variability. When lot-to-lot degradation rate variability is relatively large (CV > or = 8%) the estimated confidence intervals do not represent the trend for individual lots. In such cases it is recommended to analyze each lot individually. Copyright 2002 Wiley-Liss, Inc. and the American Pharmaceutical Association J Pharm Sci 91: 893-899, 2002

  8. The reference intervals of thyroid stimulating hormone in healthy individuals with normal levels of serum free thyroxine and without sonographic pathologies.

    PubMed

    Kutluturk, Faruk; Yildirim, Beytullah; Ozturk, Banu; Ozyurt, Huseyin; Bekar, Ulku; Sahin, Semsettin; Akturk, Yeliz; Akbas, Ali; Cetin, Ilhan; Etikan, Ilker

    2014-01-01

    The aim of the present study was to investigate the reference intervals for thyroid stimulating hormone (TSH) in healthy individuals with normal levels of serum free thyroxine (fT4) and without sonographic pathologies, and determine the effects of age, gender, and residence on the TSH reference intervals. This research was a population-based study conducted in 70 regions. The random sampling method was used to select the 1095 subjects of the study among inhabitants aged 18 and above. Patients who had a previous history of thyroid disease and had been taking medication were excluded from the study as this may have affected their fT4 or TSH levels. In addition, subjects who had serum fT4 without a reference range and abnormal ultrasonography findings were also excluded. A total of 408 subjects were used for establishing the reference intervals for TSH. The data for TSH in the study group were not normally distributed according to the Kolmogorov-Smirnov index. The geometric mean was 1.62 mIU/L, the median was 1.40 mIU/L, and the 95% reference intervals were 0.38-4.22 mIU/L. The median TSH level was higher in females compared to males (p < 0.05). In the female subjects 2.5th percentile of TSH was lower and 97.5th percentile was higher than those of males. The reference intervals of TSH were of lower values in subjects over 50 years old (p < 0.001). Studies suggest that determination of the TSH reference intervals may differ due to environmental influences or due to age, gender, and race. It is suggested that the lower limit of normal TSH for the adult Turkish population would be 0.38 mIU/L and the upper limit similar to the traditional value of 4.2 mIU/L. If each clinician uses their population-specific reference interval for TSH, thyroid function abnormalities can be accurately estimated.

  9. Collaborative study for the establishment of the WHO 3(rd) International Standard for Endotoxin, the Ph. Eur. endotoxin biological reference preparation batch 5 and the USP Reference Standard for Endotoxin Lot H0K354.

    PubMed

    Findlay, L; Desai, T; Heath, A; Poole, S; Crivellone, M; Hauck, W; Ambrose, M; Morris, T; Daas, A; Rautmann, G; Buchheit, K H; Spieser, J M; Terao, E

    2015-01-01

    An international collaborative study was organised jointly by the World Health Organization (WHO)/National Institute for Biological Standards and Control (NIBSC), the United States Pharmacopeia (USP) and the European Directorate for the Quality of Medicines & HealthCare (EDQM/Council of Europe) for the establishment of harmonised replacement endotoxin standards for these 3 organisations. Thirty-five laboratories worldwide, including Official Medicines Control Laboratories (OMCLs) and manufacturers enrolled in the study. Three candidate preparations (10/178, 10/190 and 10/196) were produced with the same material and same formulation as the current reference standards with the objective of generating a new (3(rd)) International Standard (IS) with the same potency (10 000 IU/vial) as the current (2(nd)) IS, as well as new European Pharmacopoeia (Ph. Eur.). and USP standards. The suitability of the candidate preparations to act as the reference standard in assays for endotoxin performed according to compendial methods was evaluated. Their potency was calibrated against the WHO 2(nd) IS for Endotoxin (94/580). Gelation and photometric methods produced similar results for each of the candidate preparations. The overall potency estimates for the 3 batches were comparable. Given the intrinsic assay precision, the observed differences between the batches may be considered unimportant for the intended use of these materials. Overall, these results were in line with those generated for the establishment of the current preparations of reference standards. Accelerated degradation testing of vials stored at elevated temperatures supported the long-term stability of the 3 candidate preparations. It was agreed between the 3 organisations that batch 10/178 be shared between WHO and EDQM and that batches 10/190 and 10/196 be allocated to USP, with a common assigned value of 10 000 IU/vial. This value maintains the continuity of the global harmonisation of reference materials and unitage for the testing of endotoxins in parenteral pharmaceutical products. Based on the results of the collaborative study, batch 10/178 was established by the European Pharmacopoeia Commission as the Ph. Eur. Endotoxin Biological Reference Preparation (BRP) batch 5. The same batch was also established by the Expert Committee on Biological Standardisation (ECBS) of WHO as the WHO 3(rd) IS for Endotoxin. Batch 10/190 was adopted as the USP Endotoxin Reference Standard, lot H0K354 and vials from this same batch (10/190) will serve as the United States Food and Drug Administration (USFDA) Endotoxin Standard, EC-7.

  10. Multifunctional iron oxide nanoparticles for biomedical applications

    NASA Astrophysics Data System (ADS)

    Bloemen, M.; Denis, C.; Van Stappen, T.; De Meester, L.; Geukens, N.; Gils, A.; Verbiest, T.

    2015-03-01

    Multifunctional nanoparticles have attracted a lot of attention since they can combine interesting properties like magnetism, fluorescence or plasmonic effects. As a core material, iron oxide nanoparticles have been the subject of intensive research. These cost-effective and non-toxic particles are used nowadays in many applications. We developed a heterobifunctional PEG ligand that can be used to introduce functional groups (carboxylic acids) onto the surface of the NP. Via click chemistry, a siloxane functionality was added to this ligand, for a subsequent covalent ligand exchange reaction. The functionalized nanoparticles have an excellent colloidal stability in complex environments like buffers and serum or plasma. Antibodies were coupled to the introduced carboxylic acids and these NP-antibody bioconjugates were brought into contact with Legionella bacteria for magnetic separation experiments.

  11. 76 FR 28076 - Notice of Inventory Completion: Museum of Anthropology, Washington State University, Pullman, WA...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-13

    ... scrapers, 1 bone scraper handle, 1 lot of mussel shells, 1 lot of red ochre, 2 bone awls, 1 lot of charcoal... lots of bag residue, 4 lots of animal bones, 1 stone net sinker, 1 lot of tin can fragments, 2...

  12. 9 CFR 101.6 - Cell cultures.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Cell cultures. 101.6 Section 101.6..., SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS DEFINITIONS § 101.6 Cell cultures. When used in conjunction with or in reference to cell cultures, which may be referred to as tissue cultures...

  13. 9 CFR 101.6 - Cell cultures.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Cell cultures. 101.6 Section 101.6..., SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS DEFINITIONS § 101.6 Cell cultures. When used in conjunction with or in reference to cell cultures, which may be referred to as tissue cultures...

  14. 9 CFR 101.6 - Cell cultures.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Cell cultures. 101.6 Section 101.6..., SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS DEFINITIONS § 101.6 Cell cultures. When used in conjunction with or in reference to cell cultures, which may be referred to as tissue cultures...

  15. 9 CFR 101.6 - Cell cultures.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Cell cultures. 101.6 Section 101.6..., SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS DEFINITIONS § 101.6 Cell cultures. When used in conjunction with or in reference to cell cultures, which may be referred to as tissue cultures...

  16. 9 CFR 101.6 - Cell cultures.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Cell cultures. 101.6 Section 101.6..., SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS DEFINITIONS § 101.6 Cell cultures. When used in conjunction with or in reference to cell cultures, which may be referred to as tissue cultures...

  17. A microbiological method for determining serum levels of broad spectrum β-lactam antibiotics in critically ill patients.

    PubMed

    Fridlund, Jimmy; Woksepp, Hanna; Schön, Thomas

    2016-10-01

    Recent studies show that suboptimal blood levels of β-lactam antibiotics are present in intensive care unit (ICU) patients. A common reference method for assessing drug concentrations is liquid chromatography coupled with mass-spectrometry (LC-MS) which is highly accurate but rarely available outside reference centres. Thus, our aim was to develop a microbiological method for monitoring β-lactam antibiotic serum levels which could be used at any hospital with a microbiological laboratory. The method was developed as a 96-well broth microdilution format to assess the concentrations of cefotaxime (CTX), meropenem (MER), and piperacillin (PIP). Patient serum containing antibiotics were diluted in suspensions of bacteria with known minimal inhibitory concentrations (MICs). Serum antibiotic concentrations were calculated by dividing the MIC with the dilution factor at which the serum inhibited growth of the bacterial suspension. Serum (n=88) from ICU patients at four hospitals in south-east Sweden were analysed and compared to LC-MS analysis. The overall accuracy and precision for spiked samples and patient samples was within the pre-set target of ±20.0% for all drugs. There was a significant correlation between the microbiological assay and LC-MS for the patient samples (CTX: r=0.86, n=31; MER: r=0.96, n=11; PIP: r=0.88, n=39) and the agreement around the clinical cut-off for CTX (4.0mg/l), MER (2.0mg/l) and PIP (16.0mg/l) was 90%, 100% and 87%, respectively. The microbiological method has a performance for determination of serum levels of meropenem, piperacillin and cefotaxime suitable for clinical use. It is an inexpensive method applicable in any microbiology laboratory. Copyright © 2016 Elsevier B.V. All rights reserved.

  18. Use of Fourier-transform infrared spectroscopy to quantify immunoglobulin G concentrations in alpaca serum.

    PubMed

    Burns, J; Hou, S; Riley, C B; Shaw, R A; Jewett, N; McClure, J T

    2014-01-01

    Rapid, economical, and quantitative assays for measurement of camelid serum immunoglobulin G (IgG) are limited. In camelids, failure of transfer of maternal immunoglobulins has a reported prevalence of up to 20.5%. An accurate method for quantifying serum IgG concentrations is required. To develop an infrared spectroscopy-based assay for measurement of alpaca serum IgG and compare its performance to the reference standard radial immunodiffusion (RID) assay. One hundred and seventy-five privately owned, healthy alpacas. Eighty-two serum samples were collected as convenience samples during routine herd visits whereas 93 samples were recruited from a separate study. Serum IgG concentrations were determined by RID assays and midinfrared spectra were collected for each sample. Fifty samples were set aside as the test set and the remaining 125 training samples were employed to build a calibration model using partial least squares (PLS) regression with Monte Carlo cross validation to determine the optimum number of PLS factors. The predictive performance of the calibration model was evaluated by the test set. Correlation coefficients for the IR-based assay were 0.93 and 0.87, respectively, for the entire data set and test set. Sensitivity in the diagnosis of failure of transfer of passive immunity (FTPI) ([IgG] <1,000 mg/dL) was 71.4% and specificity was 100% for the IR-based method (test set) as gauged relative to the RID reference method assay. This study indicated that infrared spectroscopy, in combination with chemometrics, is an effective method for measurement of IgG in alpaca serum. Copyright © 2014 by the American College of Veterinary Internal Medicine.

  19. Isotopic analysis of Cu in blood serum by multi-collector ICP-mass spectrometry: a new approach for the diagnosis and prognosis of liver cirrhosis?

    PubMed

    Costas-Rodríguez, Marta; Anoshkina, Yulia; Lauwens, Sara; Van Vlierberghe, Hans; Delanghe, Joris; Vanhaecke, Frank

    2015-03-01

    The isotopic composition of blood serum Cu has been investigated as a potential parameter for the diagnosis and prognosis of liver cirrhosis. Serum samples from supposedly healthy women (reference population) and from a group of female patients suffering from liver cirrhosis of different etiologies were analysed. The procedure for isolation of serum Cu and the measurement protocol for its isotopic analysis by multi-collector inductively coupled plasma-mass spectrometry (MC-ICP-MS) were evaluated. Significant differences in the isotopic composition of Cu were observed between the reference population and the patients. A wide spread in δ(65)Cu was observed within the cirrhosis population and δ(65)Cu seems to be linked to the severity of the disease. Patients with end-stage liver disease showed a significantly lighter serum Cu isotopic composition. Many clinical parameters used for the diagnosis and monitoring of liver diseases, i.e. the levels of aspartate aminotransferase, De Ritis ratio, prothrombin and international normalized ratio, albumin, bilirubin, Na and C-reactive protein, correlate well with the δ(65)Cu values, as did the ceruloplasmin level and the ceruloplasmin/Cu concentration ratio. The isotopic composition of serum Cu appears to reveal the synthetic and hepatocellular function of the liver synergistically with inflammation and fluid retention in the cohort studied. A relevant relationship was also observed between δ(65)Cu and scores of mortality risk, such as the Model for End-stage Liver Disease (MELD) and MELD-Na. Thus, the isotopic composition of serum Cu shows potential as a new approach for the prognosis of liver disease, and although further investigation is required, for evaluation of the mortality risk in end-stage liver disease and prioritization of liver transplants.

  20. Effects of Space Radiation on Humoral and Cellular Immunity in Rhesus Monkeys.

    DTIC Science & Technology

    1992-12-01

    55318-1084) immunoplates that are routinely used for quantitative assays of human Ig levels. It seemed justified to use the human system to test the...of Ig between the irradiated and control monkeys of different ages. The tests were set up and read at 18 and 72 h by the same operator, taking careful...note of the lot number and the standard reference curves for each test kit. The samples were suitably diluted to obtain clear-cut reactions (i.e

  1. Aircraft Modifications: Assessing the Current State of Air Force Aircraft Modifications and the Implications for Future Military Capability

    DTIC Science & Technology

    2007-01-25

    Air, Space , and Cyberspace." Introduction 3 group production lots together into ’spirals’ or ’increments’. These groupings, as well as an increased...important reference point for this work. The analysis of the modification process presented in this reserach , however, does help shed light on the...planning efforts. Chapter 7- The Future of Aircraft Modifications "Strategy is the art of making use of time and space . I am less concerned about the

  2. Environmental Impact Statement. Disposal and Reuse of Mather Air Force Base, California

    DTIC Science & Technology

    1992-04-01

    and Lt Col Bartol nave finished their presentations and e have you entered the hearing room tonight. The findings of that study as presented a recess...situ, but you rhe conments that you made with reference to transportation and the f ’ow of gave as some worthy comeents as to your ideas about the matter ...and whole matter of base closure. Thank you . we thnk yo for that And a lot of people including Assemblyman Consely, who is State Assemblymagn a d

  3. Validating urinary measurement of beta-2-microglobulin with a Roche reagent kit designed for serum measurements.

    PubMed

    Chan, Pak Cheung R; Kulasingam, Vathany; Lem-Ragosnig, Bonny

    2012-11-01

    To validate the use of a Roche serum beta-2-microglobulin (B2MG) kit for urinary B2MG measurements, and to establish reference limits for urinary B2MG/creatinine ratio from healthy individuals. The Roche B2MG Tina-Quant serum kit was used to measure urinary B2MG immunoturbidimetrically. Using human urine as a diluent, the B2MG method was linear from 73-2156 μg/L. The imprecision on a commercially available urine QC was 4.4% at a concentration of 380 μg/L. Limit of quantification at <20% CV was 40 μg/L. Method comparison with Immulite 2000 (Siemens) yielded slope=1.180 (95% CI 1.14-1.22), intercept=11.5 (95% CI -3.6-26.6), SEE=27.6 and r=0.99 (n=26) by the Deming regression analysis. The upper reference limit of B2MG/creatinine ratio determined from 195 healthy adults was 29 μg/mmol (97.5th centile). The serum B2MG Tina Quant reagent kit is acceptable to measure urinary B2MG. Copyright © 2012. Published by Elsevier Inc.

  4. Serum zinc, copper, retinol-binding protein, prealbumin, and ceruloplasmin concentrations in infants receiving intravenous zinc and copper supplementation.

    PubMed

    Lockitch, G; Godolphin, W; Pendray, M R; Riddell, D; Quigley, G

    1983-02-01

    One hundred twenty-seven newborn infants requiring parenteral nutrition were randomly assigned to receive differing amounts of zinc (40 to 400 micrograms/kg/day) and copper (20 or 40 micrograms/kg/day) supplementation within five birth weight groups (600 to 2,500 gm). The serum zinc concentration remained relatively constant in the group receiving the most zinc supplementation after two weeks of therapy, but declined sharply in the groups receiving less supplementation. No effect of increased copper intake was noted on ceruloplasmin values, but a difference in serum copper concentrations was noted at two weeks. No correlation was noted between serum zinc and copper values or among those for serum zinc, retinol-binding protein, and prealbumin. Reference ranges were defined for serum zinc, copper, retinol-binding protein, prealbumin, and ceruloplasmin in the preterm infant.

  5. The effect of red cell and plasma transfusion on serum zinc and copper levels in the neonate.

    PubMed

    Lockitch, G; Godolphin, W J; Pendray, M R; Quigley, G

    1983-11-01

    Transfusion of packed red cells (15 to 20 ml/kg) in 11 preterm infants resulted in a slight increase in mean serum zinc levels on the 3rd post transfusion day but no effect was noted on serum copper levels. No significant difference was found between the changes in serum zinc in 141 paired specimens collected a week apart when zero, one, two or three packed cell transfusions were given in the intervening week. A slight decrease in the mean copper level was noted when one transfusion was given. Transfusion of fresh frozen plasma in six newborns with abdominal wall defects resulted in initial serum copper levels two to three times greater than the reference mean for newborns. No effect was noted on zinc levels. Serum copper results should be interpreted with caution in infants who have been transfused with plasma.

  6. Folate and vitamin B12 status of adolescent girls in northern Nigeria.

    PubMed Central

    VanderJagt, D. J.; Spelman, K.; Ambe, J.; Datta, P.; Blackwell, W.; Crossey, M.; Glew, R. H.

    2000-01-01

    The diets of populations in many developing countries are low in folate and vitamin B12 and a deficiency of either of these vitamins results in increased risk for cardiovascular disease and neural tube defects. The rates of neural tube defects in Nigeria are among the highest reported worldwide. Since many girls marry at an early age in northern Nigeria, we therefore determined the folate and vitamin B12 status of adolescent girls between 12 and 16 years of age in Maiduguri, Nigeria. The mean serum folate concentration for subjects was 15.3 +/- 5.2 nmol/L. Whereas only four subjects (2.4%) had serum folate concentrations lower than 6.8 nmol/L, a level indicative of negative folate balance, 9% of the subjects had serum vitamin B12 concentrations at or below 134 pmol/L, the lower limit of the reference range for their age group. Serum homocysteine was measured in 56 of the 162 subjects and the mean level was 15.9 +/- 5.0 mumol/L. The majority of subjects had serum homocysteine concentrations above the upper limit of the reference range for their age group. We conclude that the adolescent girls we studied were at greater risk for vitamin B12 deficiency than folate deficiency. This conclusion is consistent with the fact that their diet included few foods that contained vitamin B12. PMID:10946529

  7. Oral cobalamin supplementation in cats with hypocobalaminaemia: a retrospective study.

    PubMed

    Toresson, Linda; Steiner, Joerg M; Olmedal, Gunilla; Larsen, MajBritt; Suchodolski, Jan S; Spillmann, Thomas

    2017-12-01

    Objectives The objective of the study was to evaluate whether oral cobalamin supplementation can restore normocobal-aminaemia in cats with hypocobalaminaemia and clinical signs of gastrointestinal disease. Methods This was a retrospective study based on a computerised database search for client-owned cats treated at Evidensia Specialist Animal Hospital, Helsingborg, Sweden, during the period December 2013 to August 2016. Inclusion criteria were cats with clinical signs of chronic enteropathy, an initial serum cobalamin concentration ⩽250 pmol/l (reference interval 214-738 pmol/l) and oral treatment with cobalamin tablets. Results Twenty-five cats met the inclusion criteria. The cats were treated with 0.25 mg cyanocobalamin tablets once daily. Serum cobalamin concentration was rechecked 27-94 days after continuous oral cobalamin supplementation. All cats had serum cobalamin concentrations above the reference interval after oral cobalamin supplementation. Median (range) serum cobalamin concentration was 128 pmol/l (111-250 pmol/l) prior to treatment and 2701 pmol/l (738-16,359 pmol/l) after supplementation. This difference was statistically significant ( P <0.0001). Conclusions and relevance Our results suggest that oral cobalamin supplementation is effective in increasing serum cobalamin to supranormal concentrations in cats with hypocobalaminaemia. Thus, oral cobalamin supplementation is a promising alternative to parenteral administration. Prospective comparative studies in cats being treated with parenteral vs oral cobalamin supplementation in a larger number of patients are warranted before oral supplementation can be recommended for routine use.

  8. Canine cancer screening via ultraviolet absorbance and fluorescence spectroscopy of serum proteins

    NASA Astrophysics Data System (ADS)

    Dickerson, Bryan D.; Geist, Brian L.; Spillman, William B., Jr.; Robertson, John L.

    2007-11-01

    A cost-effective optical cancer screening and monitoring technique was demonstrated in a pilot study of canine serum samples and was patented for commercialization. Compared to conventional blood chemistry analysis methods, more accurate estimations of the concentrations of albumin, globulins, and hemoglobin in serum were obtained by fitting the near UV absorbance and photoluminescence spectra of diluted serum as a linear combination of component reference spectra. Tracking these serum proteins over the course of treatment helped to monitor patient immune response to carcinoma and therapy. For cancer screening, 70% of dogs with clinical presentation of cancer displayed suppressed serum hemoglobin levels (below 20 mg/dL) in combination with atypical serum protein compositions, that is, albumin levels outside of a safe range (from 4 to 8 g/dL) and globulin levels above or below a more normal range (from 1.7 to 3.7 g/dL). Of the dogs that met these criteria, only 20% were given a false positive label by this cancer screening test.

  9. An improved, rapid competitive ELISA using a novel conserved 3B epitope for the detection of serum antibodies to foot-and-mouth disease virus.

    PubMed

    Chung, Chungwon J; Clavijo, Alfonso; Bounpheng, Mangkey A; Uddowla, Sabena; Sayed, Abu; Dancho, Brooke; Olesen, Ian C; Pacheco, Juan; Kamicker, Barbara J; Brake, David A; Bandaranayaka-Mudiyanselage, Carey L; Lee, Stephen S; Rai, Devendra K; Rieder, Elizabeth

    2018-06-01

    The highly contagious foot-and-mouth disease virus (FMDV) afflicts cloven-hoofed animals, resulting in significant costs because of loss of trade and recovery from disease. We developed a sensitive, specific, and rapid competitive ELISA (cELISA) to detect serum antibodies to FMDV. The cELISA utilized a monoclonal blocking antibody specific for a highly conserved FMDV nonstructural 3B epitope, a recombinant mutant FMDV 3ABC coating protein, and optimized format variables including serum incubation for 90 min at 20-25°C. Samples from 16 animals experimentally infected with one FMDV serotype (A, O, Asia, or SAT-1) demonstrated early detection capacity beginning 7 d post-inoculation. All samples from 55 vesicular stomatitis virus antibody-positive cattle and 44 samples from cloven-hoofed animals affected by non-FMD vesicular diseases were negative in the cELISA, demonstrating 100% analytical specificity. The diagnostic sensitivity was 100% against sera from 128 cattle infected with isolates of all FMDV serotypes, emphasizing serotype-agnostic results. Diagnostic specificities of U.S. cattle ( n = 1135) and swine ( n = 207) sera were 99.4% and 100%, respectively. High repeatability and reproducibility were demonstrated with 3.1% coefficient of variation in percent inhibition data and 100% agreement using 2 kit lots and 400 negative control serum samples, with no difference between bench and biosafety cabinet operation. Negative results from vaccinated, uninfected cattle, pig, and sheep sera confirmed the DIVA (differentiate infected from vaccinated animals) capability. This rapid (<3 h), select agent-free assay with high sensitivity and specificity, DIVA capability, and room temperature processing capability will serve as a useful tool in FMDV surveillance, emergency preparedness, response, and outbreak recovery programs.

  10. Intra- and extracellular magnesium levels and atheromatosis in haemodialysis patients.

    PubMed

    Tzanakis, Ioannis; Virvidakis, Kyriakos; Tsomi, Aggeliki; Mantakas, Emmanouel; Girousis, Nikolaos; Karefyllakis, Nektarios; Papadaki, Antonia; Kallivretakis, Nikolaos; Mountokalakis, Theodoros

    2004-06-01

    Traditional risk factors do not adequately explain the high prevalence of cardiovascular disease in patients with chronic renal insufficiency. Currently, there is a lot of evidence that hypomagnesaemia may play a significant role in the pathogenesis of cardiovascular diseases in general population. The aim of this study was to test the hypothesis that magnesium status in haemodialysis patients is related to the degree of atheromatosis of carotid arteries, as assessed by B-mode ultrasound. Intima-media thickness of both common carotids was assessed by B-mode ultrasound in 93 stable chronic haemodialysis patients and in 182 age- and sex-matched healthy controls. Intracellular magnesium as well as serum magnesium levels were obtained in the haemodialysis patients. Intracellular magnesium was estimated by determination of this ion in isolated peripheral lymphocytes. Haemodialysis patients had also a significantly higher mean common carotid intima-media thickness than controls (0.87+/-0.16 vs 0.76+/-0.13 mm, p < 0.001). Multivariate analysis revealed that in haemodialysis patients both serum magnesium and intracellular magnesium were negatively associated with common carotid intima-media thickness (p = 0.001 and p = 0.003 respectively). Significant associations between the age of the haemodialysis patients, the existence of diabetes mellitus as well as the serum calcium x serum phosphate product with common carotid intima-media thickness of haemodialysis patients were also observed. A strong negative association of both extracellular and intracellular magnesium with common carotid intima-media thickness exists in haemodialysis patients. The above finding suggests that magnesium may play an important protective role in the development and/or acceleration of arterial atherosclerosis in patients with chronic renal insufficiency.

  11. Identification of suitable reference gene and biomarkers of serum miRNAs for osteoporosis

    PubMed Central

    Chen, Jian; Li, Kai; Pang, Qianqian; Yang, Chao; Zhang, Hongyu; Wu, Feng; Cao, Hongqing; Liu, Hongju; Wan, Yumin; Xia, Weibo; Wang, Jinfu; Dai, Zhongquan; Li, Yinghui

    2016-01-01

    Our objective was to identify suitable reference genes in serum miRNA for normalization and screen potential new biomarkers for osteoporosis diagnosis by a systematic study. Two types of osteoporosis models were used like as mechanical unloading and estrogen deficiency. Through a large-scale screening using microarray, qPCR validation and statistical algorithms, we first identified miR-25-3p as a suitable reference gene for both type of osteoporosis, which also showed stability during the differentiation processes of osteoblast and osteoclast. Then 15 serum miRNAs with differential expression in OVX rats were identified by microarray and qPCR validation. We further detected these 15 miRNAs in postmenopausal women and bedrest rhesus monkeys and evaluated their diagnostic value by ROC analysis. Among these miRNAs, miR-30b-5p was significantly down-regulated in postmenopausal women with osteopenia or osteoporosis; miR-103-3p, miR-142-3p, miR-328-3p were only significantly decreased in osteoporosis. They all showed positive correlations with BMD. Except miR328-3p, the other three miRNAs were also declined in the rhesus monkeys after long-duration bedrest. Their AUC values (all >0.75) proved the diagnostic potential. Our results provided a reliable normalization reference gene and verified a group of circulating miRNAs as non-invasive biomarkers in the detection of postmenopausal- and mechanical unloading- osteoporosis. PMID:27821865

  12. Broiler Campylobacter Contamination and Human Campylobacteriosis in Iceland ▿ †

    PubMed Central

    Callicott, Kenneth A.; Harðardóttir, Hjördís; Georgsson, Franklín; Reiersen, Jarle; Friðriksdóttir, Vala; Gunnarsson, Eggert; Michel, Pascal; Bisaillon, Jean-Robert; Kristinsson, Karl G.; Briem, Haraldur; Hiett, Kelli L.; Needleman, David S.; Stern, Norman J.

    2008-01-01

    To examine whether there is a relationship between the degree of Campylobacter contamination observed in product lots of retail Icelandic broiler chicken carcasses and the incidence of human disease, 1,617 isolates from 327 individual product lots were genetically matched (using the flaA short variable region [SVR[) to 289 isolates from cases of human campylobacteriosis whose onset was within approximately 2 weeks from the date of processing. When there was genetic identity between broiler isolates and human isolates within the appropriate time frame, a retail product lot was classified as implicated in human disease. According to the results of this analysis, there were multiple clusters of human disease linked to the same process lot or lots. Implicated and nonimplicated retail product lots were compared for four lot descriptors: lot size, prevalence, mean contamination, and maximum contamination (as characterized by direct rinse plating). For retail product distributed fresh, Mann-Whitney U tests showed that implicated product lots had significantly (P = 0.0055) higher mean contamination than nonimplicated lots. The corresponding median values were 3.56 log CFU/carcass for implicated lots and 2.72 log CFU/carcass for nonimplicated lots. For frozen retail product, implicated lots were significantly (P = 0.0281) larger than nonimplicated lots. When the time frame was removed, retail product lots containing Campylobacter flaA SVR genotypes also seen in human disease had significantly higher mean and maximum contamination numbers than lots containing no genotypes seen in human disease for both fresh and frozen product. Our results suggest that cases of broiler-borne campylobacteriosis may occur in clusters and that the differences in mean contamination levels may provide a basis for regulatory action that is more specific than a presence-absence standard. PMID:18791017

  13. Haematological values in pregnant women in Port Harcourt, Nigeria II: Serum iron and transferrin, total and unsaturated iron binding capacity and some red cell and platelet indices.

    PubMed

    Amah-Tariah, F S; Ojeka, S O; Dapper, D V

    2011-12-20

    Previous studies on the normal values of serum iron, unsaturated iron binding capacity, total iron binding capacity, serum transferrin, percent transferrin saturation, red cell distribution width, and various platelet indices: Platelet count, mean platelet volume, platelet distribution width, plateletcrit and platelet larger cell ratio in pregnant subjects in Nigeria are relatively scanty. Present study aims to determine the values of these parameters in apparently healthy pregnant subjects residing in Port Harcourt south eastern Nigeria; and help establish normal reference ranges of these parameters for the population under reference. Cross sectional prospective study involving 220 female subjects attending for the first time, the ante-natal clinics of a tertiary health care facility in Port Harcourt. Subjects were divided into 73, 75 and 72 subjects in the first, second and third trimester of pregnancy respectively. Serum iron and unsaturated iron binding capacity, red cell distribution width, platelet count and platelet distribution width were determined by automated methods; total iron binding capacity, serum transferrin concentrations, percent transferrin saturation, mean platelet volume and plateletcrit were calculated using appropriate formulas. The values of serum iron, unsaturated iron binding capacity, total iron binding capacity and serum transferrin concentrations were found to show significant variations between the various trimesters of pregnancy. However, while serum iron showed significant decreases during pregnancy; unsaturated iron binding capacity, total iron binding capacity and serum transferrin concentrations were found to show significant increases during pregnancy amongst our subjects (p<0.05). By contrast the values of red cell distribution width, platelet count, mean platelet volume, platelet distribution width, plateletcrit and platelet larger cell ratio did not show any significant differences at the different trimesters of pregnancy in our subjects (p>0.05). The present study reports, for the first time, normative values for these parameters in apparently healthy pregnant subjects in Port Harcourt south eastern Nigeria. Apparently, increases in unsaturated and total iron binding capacity and serum transferrin values seen amongst our subjects with increasing gestation may perhaps be a mechanism to ensure a fetal adequate iron delivery on account of the decreasing serum iron concentration with gestation in our subjects. The study suggests that values of serum transferrin are perhaps a more useful screening tool for iron deficiency anemia during pregnancy amongst our subjects.

  14. Reference values for serum ferritin and percentage of transferrin saturation in Korean children and adolescents.

    PubMed

    Oh, Hea Lin; Lee, Jun Ah; Kim, Dong Ho; Lim, Jung Sub

    2018-03-01

    Ferritin reference values vary by age, gender, and ethnicity. We aimed to determine reference values of serum ferritin (SF) and the percentage of transferrin saturation (TSAT) for Korean children and adolescents. We analyzed data from 2,487 participants (1,311 males and 1,176 females) aged 10-20 years from the Korea National Health and Nutrition Examination Survey (2010-2012). We calculated age- and gender-stratified means and percentile values for SF and TSAT. We first plotted mean SF and TSAT by gender and according to age. In males, mean SF tended to be relatively constant among participants aged 10 to 14 years, with an upward trend thereafter. Mean SF trended downward among female participants until the age of 15 years and remained constant thereafter. Thus, significant gender differences in ferritin exist from the age of 14 years. High levels of SF were associated with obesity, and lower SF levels were associated with anemia and menarche status. We established reference values of SF and TSAT according to age and gender. The reference values for SF calculated in this study can be used to test the association between SF values and other defined diseases in Korean children and adolescents.

  15. Evaluation of Commercially Available Chikungunya Virus Immunoglobulin M Detection Assays

    PubMed Central

    Johnson, Barbara W.; Goodman, Christin H.; Holloway, Kimberly; de Salazar, P. Martinez; Valadere, Anne M.; Drebot, Michael A.

    2016-01-01

    Commercial chikungunya virus (CHIKV)–specific IgM detection kits were evaluated at the Centers for Disease Control and Prevention (CDC), the Public Health Agency of Canada National Microbiology Laboratory, and the Caribbean Public Health Agency (CARPHA). The Euroimmun Anti-CHIKV IgM ELISA kit had ≥ 95% concordance with all three reference laboratory results. The limit of detection for low CHIK IgM+ samples, as measured by serial dilution of seven sera up to 1:12,800 ranged from 1:800 to 1:3,200. The Euroimmun IIFT kit evaluated at CDC and CARPHA performed well, but required more retesting of equivocal results. The InBios CHIKjj Detect MAC-ELISA had 100% and 98% concordance with CDC and CARPHA results, respectively, and had equal sensitivity to the CDC MAC-ELISA to 1:12,800 dilution in serially diluted samples. The Abcam Anti-CHIKV IgM ELISA had high performance at CARPHA, but at CDC, performance was inconsistent between lots. After replacement of the biotinylated IgM antibody controls with serum containing CHIKV-specific IgM and additional quality assurance/control measures, the Abcam kit was rereleased and reevaluated at CDC. The reformatted Abcam kit had 97% concordance with CDC results and limit of detection of 1:800 to 1:3,200. Two rapid tests and three other CHIKV MAC-ELISAs evaluated at CDC had low sensitivity, as the CDC CHIKV IgM in-house positive controls were below the level of detection. In conclusion, laboratories have options for CHIKV serological diagnosis using validated commercial kits. PMID:26976887

  16. Reference intervals and diagnostic ranges for serum free κ and free λ immunoglobulin light chains vary by instrument platform: Implications for classification of patient results in a multi-center study.

    PubMed

    Cotten, Steven W; Shajani-Yi, Zahra; Cervinski, Mark A; Voorhees, Timothy; Tuchman, Sascha A; Korpi-Steiner, Nichole

    2018-06-06

    Serum free light chain (FLC) immunoglobulins are key biomarkers that aid in the diagnosis, prognosis and assessment of treatment response in patients with plasma cell disorders (PCD). Here we investigated the transference of manufacturer's reported κFLC, λFLC and κ to λ FLC reference intervals (RI) and established de novo FLC RI and diagnostic ranges on four instruments at three academic medical centers. In addition, we also compared the classification of patient FLC results using manufacturer's versus established RIs and diagnostic ranges. CLSI EP28-A3C protocol was applied to investigate transference and establishment of FLC reference intervals on the cobas (Roche), Immage (Beckman), Optilite and SPA Plus (Binding Site). Serum κ FLC and λ FLC were measured in reference sera (N = 126) with estimation of central 95% RIs and FLC ratio diagnostic range (total range). Frequencies (%) in patient FLC results (N > 380 per institution) classified above, below or within manufacturer's versus established FLC RI were compared. Three of four instrument platforms did not exhibit acceptable transference of manufacturer's reported κFLC RI. The manufacturer's reported FLC total diagnostic range did not encompass all values observed in reference sera for any of the four platforms evaluated. Established FLC ratio diagnostic ranges reduced the frequency of patient results classified above range for three of four platforms evaluated. Transference of manufacturer's reported FLC RIs may be inappropriate for select instrument platforms. De novo establishment of FLC RIs specific to instrument platform is highly recommended in order to assure correct patient result classification. Copyright © 2017. Published by Elsevier Inc.

  17. Effects of greening and community reuse of vacant lots on crime

    PubMed Central

    Kondo, Michelle; Hohl, Bernadette; Han, SeungHoon; Branas, Charles

    2016-01-01

    The Youngstown Neighborhood Development Corporation initiated a ‘Lots of Green’ programme to reuse vacant land in 2010. We performed a difference-in-differences analysis of the effects of this programme on crime in and around newly treated lots, in comparison to crimes in and around randomly selected and matched, untreated vacant lot controls. The effects of two types of vacant lot treatments on crime were tested: a cleaning and greening ‘stabilisation’ treatment and a ‘community reuse’ treatment mostly involving community gardens. The combined effects of both types of vacant lot treatments were also tested. After adjustment for various sociodemographic factors, linear and Poisson regression models demonstrated statistically significant reductions in all crime classes for at least one lot treatment type. Regression models adjusted for spatial autocorrelation found the most consistent significant reductions in burglaries around stabilisation lots, and in assaults around community reuse lots. Spill-over crime reduction effects were found in contiguous areas around newly treated lots. Significant increases in motor vehicle thefts around both types of lots were also found after they had been greened. Community-initiated vacant lot greening may have a greater impact on reducing more serious, violent crimes. PMID:28529389

  18. Vanadium release in whole blood, serum and urine of patients implanted with a titanium alloy hip prosthesis.

    PubMed

    Catalani, S; Stea, S; Beraudi, A; Gilberti, M E; Bordini, B; Toni, A; Apostoli, P

    2013-08-01

    Vanadium (V) is a minor constituent of the Titanium-Aluminum-Vanadium (TiAlV) alloy currently used in cementless hip prostheses. Present study aimed at verifying the correlation of vanadium levels among different matrices and assessing reference levels of the ion in a population of patients wearing a well-functioning hip prosthesis. Vanadium was measured using Inductive Coupled Plasma Mass Spectrometry (ICP-MS) in whole blood, serum and urine of 129 patients implanted with a TiAlV-alloy hip prosthesis. The values in the serum were above the upper limit of the reference values in 42% of patients (29% in urine and 13% in whole blood). A good correlation among matrices was observed (p < 0.001). The cohort of patients (N = 32) complaining of pain or in which a loosening or damage to the prosthesis was assessed showed a significantly higher excretion of vanadium in urine as compared with the remaining asymptomatic patients (p = 0.001). The 95th percentile distribution of vanadium in the cohort of patients with a well-functioning prosthesis was 0.3 μg/L in whole blood, 0.5 μg/L in serum and 2.8 μg/L in urine, higher that in the unexposed population, especially for urine. The presence of a prosthesis, even though well-functioning, may cause a possible release of vanadium into the blood and a significant urinary excretion. The reference values of vanadium of the asymptomatic patients with titanium alloy hip prostheses supplied information regarding the background exposure level of the ions and their lower and upper limits.

  19. Reference Intervals for Preprandial and Postprandial Serum Bile Acid in Adult Rhesus Macaques (Macaca mulatta)

    PubMed Central

    Lemoy, Marie-Josee MF; Westworth, Diccon R; Ardeshir, Amir; Tarara, Ross P

    2013-01-01

    The purpose of this study was to determine the 12-h fasting preprandial and 2-h postprandial serum bile acid concentration (SBAC) reference intervals for healthy, adult rhesus macaques (Macaca mulatta). We hypothesized that the mean 2-h postprandial SBAC would be significantly higher than the mean preprandial SBAC. We included 40 (24 male, 16 female) macaques after confirming that their health records, physical examinations, CBC, serum chemistry panels, and urinalyses were all within normal limits. In addition, hepatitis A titers were determined, an ultrasound examination of the liver was performed, and two 16-gauge ultrasound guided percutaneous liver biopsies were collected and submitted for histopathology. Macaques were confirmed healthy according to hepatitis A screens and sonographic and histologic evaluation of hepatic tissue. Within 2 wk of the screening procedures, preprandial and postprandial SBACs were measured. Preprandial SBAC (mean ± 1 SD) was 11.1 ± 1.9 µmol/L and postprandial SBAC was 19.7 ± 8.0 µmol/L, which was significantly higher than the preprandial value. Sex and hepatitis titers did not significantly influence preprandial and postprandial SBAC. The current study indicates that the SBAC reference values for rhesus macaques are higher than those reported for humans and companion animals. PMID:23849441

  20. Reference intervals for preprandial and postprandial serum bile acid in adult rhesus macaques (Macaca mulatta).

    PubMed

    Lemoy, Marie-Josee M F; Westworth, Diccon R; Ardeshir, Amir; Tarara, Ross P

    2013-07-01

    The purpose of this study was to determine the 12-h fasting preprandial and 2-h postprandial serum bile acid concentration (SBAC) reference intervals for healthy, adult rhesus macaques (Macaca mulatta). We hypothesized that the mean 2-h postprandial SBAC would be significantly higher than the mean preprandial SBAC. We included 40 (24 male, 16 female) macaques after confirming that their health records, physical examinations, CBC, serum chemistry panels, and urinalyses were all within normal limits. In addition, hepatitis A titers were determined, an ultrasound examination of the liver was performed, and two 16-gauge ultrasound guided percutaneous liver biopsies were collected and submitted for histopathology. Macaques were confirmed healthy according to hepatitis A screens and sonographic and histologic evaluation of hepatic tissue. Within 2 wk of the screening procedures, preprandial and postprandial SBACs were measured. Preprandial SBAC (mean ± 1 SD) was 11.1 ± 1.9 μmol/L and postprandial SBAC was 19.7 ± 8.0 μmol/L, which was significantly higher than the preprandial value. Sex and hepatitis titers did not significantly influence preprandial and postprandial SBAC. The current study indicates that the SBAC reference values for rhesus macaques are higher than those reported for humans and companion animals.

  1. Reference values of blood parameters in beef cattle of different ages and stages of lactation.

    PubMed Central

    Doornenbal, H; Tong, A K; Murray, N L

    1988-01-01

    Reference (normal) values for 12 blood serum components were determined for 48 Shorthorn cows (2-10 years old) and their 48 calves, 357 crossbred cows (12-14 years old), 36 feedlot bulls and 36 feedlot steers. In addition, hemoglobin, hematocrit, triiodothyronine, thyroxine and cortisol levels were determined for the crossbred cows, and feedlot bulls and steers. Reference values were tabulated according to sex, age and stage of lactation. Serum concentrations of urea, total protein and bilirubin, and serum activity of aspartate aminotransferase and lactate dehydrogenase increased with age (P less than 0.05), while calcium, phosphorus and alkaline phosphatase decreased with age (P less than 0.05) from birth to the age of ten years. The Shorthorn cows had the highest levels of glucose at parturition (P less than 0.05) with decreasing levels during lactation. Creatinine concentration decreased during lactation and increased during postweaning. Both lactate dehydrogenase and aspartate aminotransferase levels increased (P less than 0.05) during lactation. Urea and uric acid were present at higher concentrations in lactating than nonlactating cows (P less than 0.05). The values reported, based on a wide age range and large number of cattle, could serve as clinical guides and a basis for further research. PMID:3349406

  2. Current Practices of Measuring and Reference Range Reporting of Free and Total Testosterone in the United States.

    PubMed

    Le, Margaret; Flores, David; May, Danica; Gourley, Eric; Nangia, Ajay K

    2016-05-01

    The evaluation and management of male hypogonadism should be based on symptoms and on serum testosterone levels. Diagnostically this relies on accurate testing and reference values. Our objective was to define the distribution of reference values and assays for free and total testosterone by clinical laboratories in the United States. Upper and lower reference values, assay methodology and source of published reference ranges were obtained from laboratories across the country. A standardized survey was reviewed with laboratory staff via telephone. Descriptive statistics were used to tabulate results. We surveyed a total of 120 laboratories in 47 states. Total testosterone was measured in house at 73% of laboratories. At the remaining laboratories studies were sent to larger centralized reference facilities. The mean ± SD lower reference value of total testosterone was 231 ± 46 ng/dl (range 160 to 300) and the mean upper limit was 850 ± 141 ng/dl (range 726 to 1,130). Only 9% of laboratories where in-house total testosterone testing was performed created a reference range unique to their region. Others validated the instrument recommended reference values in a small number of internal test samples. For free testosterone 82% of laboratories sent testing to larger centralized reference laboratories where equilibrium dialysis and/or liquid chromatography with mass spectrometry was done. The remaining laboratories used published algorithms to calculate serum free testosterone. Reference ranges for testosterone assays vary significantly among laboratories. The ranges are predominantly defined by limited population studies of men with unknown medical and reproductive histories. These poorly defined and variable reference values, especially the lower limit, affect how clinicians determine treatment. Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  3. Simultaneous determination of creatinine and creatine in human serum by double-spike isotope dilution liquid chromatography-tandem mass spectrometry (LC-MS/MS) and gas chromatography-mass spectrometry (GC-MS).

    PubMed

    Fernández-Fernández, Mario; Rodríguez-González, Pablo; Añón Álvarez, M Elena; Rodríguez, Felix; Menéndez, Francisco V Álvarez; García Alonso, J Ignacio

    2015-04-07

    This work describes the first multiple spiking isotope dilution procedure for organic compounds using (13)C labeling. A double-spiking isotope dilution method capable of correcting and quantifying the creatine-creatinine interconversion occurring during the analytical determination of both compounds in human serum is presented. The determination of serum creatinine may be affected by the interconversion between creatine and creatinine during sample preparation or by inefficient chemical separation of those compounds by solid phase extraction (SPE). The methodology is based on the use differently labeled (13)C analogues ((13)C1-creatinine and (13)C2-creatine), the measurement of the isotopic distribution of creatine and creatinine by liquid chromatography-tandem mass spectrometry (LC-MS/MS) and the application of multiple linear regression. Five different lyophilized serum-based controls and two certified human serum reference materials (ERM-DA252a and ERM-DA253a) were analyzed to evaluate the accuracy and precision of the proposed double-spike LC-MS/MS method. The methodology was applied to study the creatine-creatinine interconversion during LC-MS/MS and gas chromatography-mass spectrometry (GC-MS) analyses and the separation efficiency of the SPE step required in the traditional gas chromatography-isotope dilution mass spectrometry (GC-IDMS) reference methods employed for the determination of serum creatinine. The analysis of real serum samples by GC-MS showed that creatine-creatinine separation by SPE can be a nonquantitative step that may induce creatinine overestimations up to 28% in samples containing high amounts of creatine. Also, a detectable conversion of creatine into creatinine was observed during sample preparation for LC-MS/MS. The developed double-spike LC-MS/MS improves the current state of the art for the determination of creatinine in human serum by isotope dilution mass spectrometry (IDMS), because corrections are made for all the possible errors derived from the sample preparation step.

  4. Activin B is a novel biomarker for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) diagnosis: a cross sectional study.

    PubMed

    Lidbury, Brett A; Kita, Badia; Lewis, Donald P; Hayward, Susan; Ludlow, Helen; Hedger, Mark P; de Kretser, David M

    2017-03-16

    Investigations of activin family proteins as serum biomarkers for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). CFS/ME is a disease with complex, wide-ranging symptoms, featuring persistent fatigue of 6 months or longer, particularly post exertion. No definitive biomarkers are available. A cross-sectional, observational study of CFS/ME patients fulfilling the 2003 Canadian Consensus Criteria, in parallel with healthy non-fatigued controls, was conducted. Comparisons with a previously defined activin reference population were also performed. For the total study cohort the age range was 18-65 years with a female: male participant ratio of greater than 3:1. All participants were assessed via a primary care community clinic. Blood samples were collected for pathology testing after physical examination and orthostatic intolerance assessment. Cytokines, activin A, activin B and follistatin were also measured in sera from these samples. All data were compared between the CFS/ME and control cohorts, with the activins and follistatin also compared with previously defined reference intervals. Serum activin B levels for CFS/ME participants were significantly elevated when compared to the study controls, as well as the established reference interval. Serum activin A and follistatin were within their normal ranges. All routine and special pathology markers were within the normal laboratory reference intervals for the total study cohort, with no significant differences detected between CFS/ME and control groups. Also, no significant differences were detected for IL-2, IL-4, IL-6, IL-10, IL-17A, TNF or IFN-gamma. Elevated activin B levels together with normal activin A levels identified patients with the diagnostic symptoms of CFS/ME, thus providing a novel serum based test. The activins have multiple physiological roles and capture the diverse array of symptoms experienced by CFS/ME patients.

  5. Hematology and serum biochemistry of Sumatran rhinoceroses (Dicerorhinus sumatrensis) in a rainforest sanctuary in Way Kambas National Park, Indonesia.

    PubMed

    Andriansyah; Candra, Dedi; Riyanto, Marcellus A C T; Barry, Jason; Radcliffe, Robin W

    2013-06-01

    There is a paucity of basic biological information for the Sumatran rhinoceros (Dicerorhinus sumatrensis). This information is fundamental to husbandry and management practices for captive animals and for support of in situ conservation efforts. Serial blood samples were collected over an 8-yr period to evaluate patterns in hematology and serum biochemistry values among five Sumatran rhinoceroses housed at the Sumatran Rhino Sanctuary in Way Kambas National Park, Lampung, Indonesia. Understanding the basis for variance in analytes both within and between subjects can allow use of more sensitive subject-based reference values, and is particularly suitable for small populations of endangered animals. Both intra- and intersubject variability was computed for each analyte and the associated index of individuality was determined. Previously published cutoff points for index of individuality indicate where population-based reference intervals can be used with confidence (index > 1.4) or with caution (0.6 < index < 1.4). Interrhino variability was small for the majority of analytes, with 12 of 19 analytes having an index of individuality greater than 1.4 and none having an index of individuality less than 0.6. With the high within-individual variability of most anayltes in the Sumatran rhinoceroses at the sanctuary, subject-based reference intervals offer little advantage over standard population-based reference intervals for monitoring the health of these endangered animals. Differences were noted (but not tested for statistical significance) in serum urea, aspartate aminotransferase (AST), lactate dehydrogenase (LDH), and cholesterol between young and old rhinoceroses, and in hematocrit, AST, alanine aminotransferase (ALT), LDH, and glucose between male and female rhinoceroses. Husbandry practices, animal management, nutrition and habitat factors may also impact hematology and biochemistry results, and these relationships deserve more careful investigation. This study represents the most comprehensive hematology and serum biochemistry comparison of Sumatran rhinoceroses held in natural rainforest conditions outside a traditional zoological setting.

  6. Co-infections with Chikungunya and Dengue Viruses, Guatemala, 2015.

    PubMed

    Edwards, Thomas; Signor, Leticia Del Carmen Castillo; Williams, Christopher; Donis, Evelin; Cuevas, Luis E; Adams, Emily R

    2016-11-01

    We screened serum samples referred to the national reference laboratory in Guatemala that were positive for chikungunya or dengue viruses in June 2015. Co-infection with both viruses was detected by reverse transcription PCR in 46 (32%) of 144 samples. Specimens should be tested for both arboviruses to detect co-infections.

  7. Hematology and Serum Biochemistry Reference Intervals for Six-Week-Old, Farm-Reared Chinese Ring-Necked Pheasants ( Phasianus colchicus ) from Minnesota.

    PubMed

    Dzikamunhenga, R S; Griffith, R W; Hostetter, S; Fisher, P; Larson, W

    2017-06-01

    Chinese ring-necked pheasants ( Phasianus colchicus ) are commonly farmed in intensive operations for purposes such as meat production, hunting preserves, or research. Under these conditions, pheasants frequently suffer medical ailments such as bacterial, viral, and parasitic infections or nutritional or metabolic disorders. Relatively little scientific information exists regarding clinical pathology reference intervals (RIs) for farm-reared pheasants. The objective of this study was to determine RIs for hematologic and serum biochemical variables for Chinese ring-necked pheasants from Minnesota at 6 wk of age. Blood samples from 119 clinically healthy Chinese ring-necked pheasants were analyzed using standard techniques. Reference intervals were generated in Microsoft® Excel® 2013 (Microsoft, Redmond, WA) using Reference Value Advisor freeware version 2.1 (Microsoft). Ninety-five percent RIs were determined using nonparametric methods that followed Clinical and Laboratory Standards Institute guidelines. These RIs will be useful for the monitoring of health and diagnosis of disease in confined Chinese ring-necked pheasant populations that are approximately 6 wk old.

  8. Mechanisms involved in the blood-testis barrier increased permeability induced by EMP.

    PubMed

    Wang, Xiao-Wu; Ding, Gui-Rong; Shi, Chang-Hong; Zeng, Li-Hua; Liu, Jun-Ye; Li, Jing; Zhao, Tao; Chen, Yong-Bin; Guo, Guo-Zhen

    2010-09-30

    The blood-testis barrier (BTB) plays an important role in male reproductive system. Lots of environmental stimulations can increase the permeability of BTB and then result in antisperm antibody (AsAb) generation, which is a key step in male immune infertility. Here we reported the results of male mice exposed to electromagnetic pulse (EMP) by measuring the expression of tight-junction-associated proteins (ZO-1 and Occludin), vimentin microfilaments, and transforming growth factor-beta (TGF-beta3) as well as AsAb level in serum. Male BALB/c mice were sham exposed or exposed to EMP at two different intensities (200kV/m and 400kV/m) for 200 pulses. The testes were collected at different time points after EMP exposure. Immunofluorescence histocytochemistry, western blotting, laser confocal microscopy and RT-PCR were used in this study. Compared with sham group, the expression of ZO-1 and TGF-beta3 significantly decreased accompanied with unevenly stained vimentin microfilaments and increased serum AsAb levels in EMP-exposed mice. These results suggest a potential BTB injury and immune infertility in male mice exposed to a certain intensity of EMP. Copyright 2010 Elsevier Ireland Ltd. All rights reserved.

  9. 75 FR 80872 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-23

    ... which it handles and executes odd lot and mixed lot orders.\\3\\ If CBSX is not displaying the NBBO and... mixed lot orders will be handled and executed in a more consistent manner with round lot orders. \\3\\ A... lot'' order is an order for a quantity that is less than 100. A ``mixed lot'' order is an order for a...

  10. Serum protein concentrations from clinically healthy horses determined by agarose gel electrophoresis.

    PubMed

    Riond, Barbara; Wenger-Riggenbach, Bettina; Hofmann-Lehmann, Regina; Lutz, Hans

    2009-03-01

    Serum protein electrophoresis is a useful screening test in equine laboratory medicine. The method can provide valuable information about changes in the concentrations of albumin and alpha-, beta-, and gamma-globulins and thereby help characterize dysproteinemias in equine patients. Reference values for horses using agarose gel as a support medium have not been reported. The purpose of this study was to establish reference intervals for serum protein concentrations in adult horses using agarose gel electrophoresis and to assess differences between warm-blooded and heavy draught horses. In addition, the precision of electrophoresis for determining fraction percentages and the detection limit were determined. Blood samples were obtained from 126 clinically healthy horses, including 105 Thoroughbreds and 21 heavy draught horses of both sexes and ranging from 2 to 20 years of age. The total protein concentration was determined by an automated biuret method. Serum protein electrophoresis was performed using a semi-automated agarose gel electrophoresis system. Coefficients of variation (CVs) were calculated for within-run and within-assay precision. Data from warm-blooded and draught horses were compared using the Mann-Whitney U test. Within-run and within-assay CVs were <5% for all protein fractions. No significant difference was found between warm-blooded and heavy draught horses and so combined reference intervals (2.5-97.5%) were calculated for total protein (51.0-72.0 g/L), albumin (29.6-38.5 g/L), alpha(1)-globulin (1.9-3.1 g/L), alpha(2)-globulin (5.3-8.7 g/L), beta(1)-globulin (2.8-7.3g/L), beta(2)-globulin (2.2-6.0 g/L), and gamma-globulin (5.8-12.7 g/L) concentrations, and albumin/globulin ratio (0.93-1.65). Using agarose gel as the supporting matrix for serum protein electrophoresis in horses resulted in excellent resolution and accurate results that facilitated standardization into 6 protein fractions.

  11. Evaluation of four commercial biuret reagent kits of serum total protein by the American Association for Clinical Chemistry reference measurement procedure.

    PubMed

    He, Meilin; Zhang, Jie

    2011-06-01

    In China, the traceability of clinical chemistry methods is still immature. Therefore, it is necessary to establish a reference measurement procedure and evaluate commercial reagent kits using such established procedures. We reproduced the reference measurement procedure for serum total protein, as recommended by the American Association for Clinical Chemistry (AACC). We evaluated the performance by Clinical Laboratory Standard Institute (CLSI) guidelines EP15-A and EP6-A. Subsequently, four commercial reagent kits were evaluated by the reproduced reference procedure following CLSI guideline EP9-A2. The performance of the reproduced reference procedure was as follows: CVs ranged from 0.47% to 0.85% at medical decision levels (X(c)) of 45 g/L, 60 g/L and 80 g/L. Linearity was Y=1.0022X-0.2121 (r=0.9999), and recovery ranged from 100.2% to 102.4%. The External Quality Assessment Scheme for Reference Laboratories in Laboratory Medicine (RELA) was applied, and the result was within the limit of equivalence. The linear relationships of four commercial reagent kits, Merit Choice, KHB, Leadman, and Olympus, were, respectively: Y=0.9922X+0.5776 (r=0.9961); Y=0.9936X+0.4316 (r=0.9992); Y=0.9949X+0.9129 (r=0.9987) and Y=0.9923X+0.8876 (r=0.9989). KHB showed slight negative bias, and the mean±SD was -0.03±0.60 g/L. Merit Choice, Leadman, and Olympus all showed positive bias, and the mean±SDs were 0.02±0.63 g/L, 0.55±0.77 g/L and 0.34±0.71 g/L, respectively. The correlation and bias of four commercial reagent kits for serum total protein were found to be acceptable. Thus, these reagent kits can be used reliably in China.

  12. Validation of serum free light chain reference ranges in primary care.

    PubMed

    Galvani, Luca; Flanagan, Jane; Sargazi, Mansour; Neithercut, William D

    2016-05-01

    The demand for measurement of serum immunoglobulin free kappa (κ) and lambda (λ) light chains has increased. The κ:λ ratio is used to assist in diagnosis/monitoring of plasma cell disorders. The binding site reference range for serum-free light chain κ:λ ratios of 0.26-1.65 was derived from healthy volunteers. Subsequently, a reference range of 0.37-3.1 for patients with chronic kidney disease has been proposed. Elevated free light chain concentrations and borderline raised free light chain ratios also may be found in polyclonal gammopathies and with other non-renal illnesses. This assessment was conducted to validate the established free light chain reference ranges in individuals from primary care. A total of 130 samples were identified from routine blood samples collected in primary care for routine biochemistry testing and estimated glomerular filtration rate calculation. The median and range of κ:λ ratios found in each estimated glomerular filtration rate group used for chronic kidney disease classification were higher than previously described. This was the case for individuals with normal or essentially normal renal function with estimated glomerular filtration rates>90, (0.58-1.76) and estimated glomerular filtration rate of 60-90 mL/min/1.73 m(2), (0.71-1.93). Individuals with estimated glomerular filtration rate 15-30, (0.72-4.50) and estimated glomerular filtration rate <15 ml/min/1.73 m(2) (0.71-4.95) also had higher values when compared to the current renal reference range of 0.37-3.10. Elevation of free light chain-κ:λ ratios may occur in the absence of a reduced renal function shown by a normal estimated glomerular filtration rate and in the presence of reduced renal function by estimated glomerular filtration rate when comparing results with the established reference ranges. Explanations include choice of analytical systems or the presence of other concurrent non-plasma cell illness. © The Author(s) 2016.

  13. Comprehensive analysis of statistical and model-based overlay lot disposition methods

    NASA Astrophysics Data System (ADS)

    Crow, David A.; Flugaur, Ken; Pellegrini, Joseph C.; Joubert, Etienne L.

    2001-08-01

    Overlay lot disposition algorithms in lithography occupy some of the highest leverage decision points in the microelectronic manufacturing process. In a typical large volume sub-0.18micrometers fab the lithography lot disposition decision is made about 500 times per day. Each decision will send a lot of wafers either to the next irreversible process step or back to rework in an attempt to improve unacceptable overlay performance. In the case of rework, the intention is that the reworked lot will represent better yield (and thus more value) than the original lot and that the enhanced lot value will exceed the cost of rework. Given that the estimated cost of reworking a critical-level lot is around 10,000 (based upon the opportunity cost of consuming time on a state-of-the-art DUV scanner), we are faced with the implication that the lithography lot disposition decision process impacts up to 5 million per day in decisions. That means that a 1% error rate in this decision process represents over 18 million per year lost in profit for a representative sit. Remarkably, despite this huge leverage, the lithography lot disposition decision algorithm usually receives minimal attention. In many cases, this lack of attention has resulted in the retention of sub-optimal algorithms from earlier process generations and a significant negative impact on the economic output of many high-volume manufacturing sites. An ideal lot- dispositioning algorithm would be an algorithm that results into the best economic decision being made every time - lots would only be reworked where the expected value (EV) of the reworked lot minus the expected value of the original lot exceeds the cost of the rework: EV(reworked lot)- EV(original lot)>COST(rework process) Calculating the above expected values in real-time has generally been deemed too complicated and maintenance-intensive to be practical for fab operations, so a simplified rule is typically used.

  14. Measurement of super large radius optics in the detection of gravitational waves

    NASA Astrophysics Data System (ADS)

    Yang, Cheng; Han, Sen; Wu, Quanying; Liang, Binming; Hou, Changlun

    2015-10-01

    The existence of Gravitational Wave (GW) is one of the greatest predictions of Einstein's relative theory. It has played an important part in the radiation theory, black hole theory, space explore and so on. The GW detection has been an important aspect of modern physics. With the research proceeding further, there are still a lot of challenges existing in the interferometer which is the key instrument in GW detection especially the measurement of the super large radius optics. To solve this problem, one solution , Fizeau interference, for measuring the super large radius has been presented. We change the tradition that curved surface must be measured with a standard curved surface. We use a flat mirror as a reference flat and it can lower both the cost and the test requirement a lot. We select a concave mirror with the radius of 1600mm as a sample. After the precision measurement and analysis, the experimental results show that the relative error of radius is better than 3%, and it can fully meet the requirements of the measurement of super large radius optics. When calculating each pixel with standard cylinder, the edges are not sharp because of diffraction or some other reasons, we detect the edge and calculate the diameter of the cylinder automatically, and it can improve the precision a lot. In general, this method is simple, fast, non-traumatic, and highly precision, it can also provide us a new though in the measurement of super large radius optics.

  15. Immunogenicity and safety of the candidate RTS,S/AS01 vaccine in young Nigerian children: a randomized, double-blind, lot-to-lot consistency trial.

    PubMed

    Umeh, Rich; Oguche, Stephen; Oguonu, Tagbo; Pitmang, Simon; Shu, Elvis; Onyia, Jude-Tony; Daniyam, Comfort A; Shwe, David; Ahmad, Abdullahi; Jongert, Erik; Catteau, Grégory; Lievens, Marc; Ofori-Anyinam, Opokua; Leach, Amanda

    2014-11-12

    For regulatory approval, consistency in manufacturing of vaccine lots is expected to be demonstrated in confirmatory immunogenicity studies using two-sided equivalence trials. This randomized, double-blind study (NCT01323972) assessed consistency of three RTS,S/AS01 malaria vaccine batches formulated from commercial-scale purified antigen bulk lots in terms of anti-CS-responses induced. Healthy children aged 5-17 months were randomized (1:1:1:1) to receive RTS,S/AS01 at 0-1-2 months from one of three commercial-scale purified antigen bulk lots (1600 litres-fermentation scale; commercial-scale lots), or a comparator vaccine batch made from pilot-scale purified antigen bulk lot (20 litres-fermentation scale; pilot-scale lot). The co-primary objectives were to first demonstrate consistency of antibody responses against circumsporozoite (CS) protein at one month post-dose 3 for the three commercial-scale lots and second demonstrate non-inferiority of anti-CS antibody responses at one month post-dose 3 for the commercial-scale lots compared to the pilot-scale lot. Safety and reactogenicity were evaluated as secondary endpoints. One month post-dose-3, anti-CS antibody geometric mean titres (GMT) for the 3 commercial scale lots were 319.6 EU/ml (95% confidence interval (CI): 268.9-379.8), 241.4 EU/ml (207.6-280.7), and 302.3 EU/ml (259.4-352.3). Consistency for the RTS,S/AS01 commercial-scale lots was demonstrated as the two-sided 95% CI of the anti-CS antibody GMT ratio between each pair of lots was within the range of 0.5-2.0. GMT of the pooled commercial-scale lots (285.8 EU/ml (260.7-313.3)) was non-inferior to the pilot-scale lot (271.7 EU/ml (228.5-323.1)). Each RTS,S/AS01 lot had an acceptable tolerability profile, with infrequent reports of grade 3 solicited symptoms. No safety signals were identified and no serious adverse events were considered related to vaccination. RTS,S/AS01 lots formulated from commercial-scale purified antigen bulk batches induced a consistent anti-CS antibody response, and the anti-CS GMT of pooled commercial-scale lots was non-inferior to that of a lot formulated from a pilot-scale antigen bulk batch. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  16. Pentobarbital quantitation using EMIT serum barbiturate assay reagents: application to monitoring of high-dose pentobarbital therapy.

    PubMed

    Pape, B E; Cary, P L; Clay, L C; Godolphin, W

    1983-01-01

    Pentobarbital serum concentrations associated with a high-dose therapeutic regimen were determined using EMIT immunoassay reagents. Replicate analyses of serum controls resulted in a within-assay coefficient of variation of 5.0% and a between-assay coefficient of variation of 10%. Regression analysis of 44 serum samples analyzed by this technique (y) and a reference procedure (x) were y = 0.98x + 3.6 (r = 0.98; x = ultraviolet spectroscopy) and y = 1.04x + 2.4 (r = 0.96; x = high-performance liquid chromatography). Clinical evaluation of the results indicates the immunoassay is sufficiently sensitive and selective for pentobarbital to allow accurate quantitation within the therapeutic range associated with high-dose therapy.

  17. Potential Health Benefits of Deep Sea Water: A Review

    PubMed Central

    Jaafar, A. B.; Mahdzir, A.; Musa, M. N.

    2016-01-01

    Deep sea water (DSW) commonly refers to a body of seawater that is pumped up from a depth of over 200 m. It is usually associated with the following characteristics: low temperature, high purity, and being rich with nutrients, namely, beneficial elements, which include magnesium, calcium, potassium, chromium, selenium, zinc, and vanadium. Less photosynthesis of plant planktons, consumption of nutrients, and organic decomposition have caused lots of nutrients to remain there. Due to this, DSW has potential to become a good source for health. Research has proven that DSW can help overcome health problems especially related to lifestyle-associated diseases such as cardiovascular disease, diabetes, obesity, cancer, and skin problems. This paper reviews the potential health benefits of DSW by referring to the findings from previous researches. PMID:28105060

  18. Potential Health Benefits of Deep Sea Water: A Review.

    PubMed

    Mohd Nani, Samihah Zura; Majid, F A A; Jaafar, A B; Mahdzir, A; Musa, M N

    2016-01-01

    Deep sea water (DSW) commonly refers to a body of seawater that is pumped up from a depth of over 200 m. It is usually associated with the following characteristics: low temperature, high purity, and being rich with nutrients, namely, beneficial elements, which include magnesium, calcium, potassium, chromium, selenium, zinc, and vanadium. Less photosynthesis of plant planktons, consumption of nutrients, and organic decomposition have caused lots of nutrients to remain there. Due to this, DSW has potential to become a good source for health. Research has proven that DSW can help overcome health problems especially related to lifestyle-associated diseases such as cardiovascular disease, diabetes, obesity, cancer, and skin problems. This paper reviews the potential health benefits of DSW by referring to the findings from previous researches.

  19. 7 CFR 983.52 - Failed lots/rework procedure.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ..., ARIZONA, AND NEW MEXICO Regulations § 983.52 Failed lots/rework procedure. (a) Substandard pistachios. Each lot of substandard pistachios may be reworked to meet aflatoxin or quality requirements. The... reporting. If a lot fails to meet the aflatoxin and/or the quality requirements of this part, a failed lot...

  20. Tocopherol in Elder Self-Neglect

    NASA Technical Reports Server (NTRS)

    Aung, K.; Burnett, J.; Dyer, C.; Smith, S. M.

    2009-01-01

    Although elder self-neglect is the most common form of elder mistreatment, its pathophysiology is not well understood. Alpha-tocopherol is a lipid soluble antioxidant required for the preservation of cell membranes. Since the association between tocopherol and cognitive impairment in older adults has been described, we explored the possibility of its role in elder self-neglect. OBJECTIVE: (1) To determine whether serum tocopherol levels are associated with elder self-neglect, and (2) to assess the association of serum tocopherol levels and cognitive function in elder self-neglect. METHODS: Serum tocopherol levels were measured in a cohort of 67 self-neglecting elders and 67 matched controls, recruited for the Consortium for Research in Elder Self-neglect of Texas. Pearson s correlation tests were performed to assess bivariate associations between serum tocopherol levels and cognitive function. RESULTS: Mean serum alpha-tocopherol levels were 10.8 +/- 4.7 ug/mL in self-neglect group and 13.0 +/- 4.9 ug/mL in control group (p = 0.006, unpaired student s t-test). None of the participants from either group had alpha-tocopherol level lower than the reference range. Mean serum gamma-tocopherol levels were 2.0 +/- 1.0 ug/mL in self-neglect group and 2.0 +/- 1.1 in control group (p=0.83). Proportion of the elders with gamma-tocopherol level lower than the reference range were 4.5% (3/66) in self-neglect group and 10.4% (7/67) in control group (p=0.32, Fisher s Exact Test). Among the self-neglecting elders, no association was found between serum alpha-tocopherol levels and the Mini-Mental State Examination (MMSE) or the Wolf-Klein Clock Drawing Test (CDT) scores (r =-0.42, p=0.75 for MMSE; r=0.08, p=0.54 for CDT). No association was found between serum gamma-tocopherol levels and the MMSE or the CDT (r=-0.12, p=0.35 for MMSE; r=0.05, p=0.68 for CDT). CONCLUSION: In our sample, neither alpha-tocopherol nor gamma-tocopherol appears to have a role in pathophysiology of elder self-neglect. Nevertheless, significantly lower serum alpha-tocopherol levels in the self neglect group merits further research.

  1. Short term serum pharmacokinetics of diammine silver fluoride after oral application.

    PubMed

    Vasquez, Elsa; Zegarra, Graciela; Chirinos, Edgar; Castillo, Jorge L; Taves, Donald R; Watson, Gene E; Dills, Russell; Mancl, Lloyd L; Milgrom, Peter

    2012-12-31

    There is growing interest in the use of diammine silver fluoride (DSF) as a topical agent to treat dentin hypersensitivity and dental caries as gauged by increasing published research from many parts of the world. While DSF has been available in various formulations for many years, most of its pharmacokinetic aspects within the therapeutic concentration range have never been fully characterized. This preliminary study determined the applied doses (3 teeth treated), maximum serum concentrations, and time to maximum serum concentration for fluoride and silver in 6 adults over 4 h. Fluoride was determined using the indirect diffusion method with a fluoride selective electrode, and silver was determined using inductively coupled plasma-mass spectrometry. The mean amount of DSF solution applied to the 3 teeth was 7.57 mg (6.04 μL). Over the 4 hour observation period, the mean maximum serum concentrations were 1.86 μmol/L for fluoride and 206 nmol/L for silver. These maximums were reached 3.0 h and 2.5 h for fluoride and silver, respectively. Fluoride exposure was below the U.S. Environmental Protection Agency (EPA) oral reference dose. Silver exposure exceeded the EPA oral reference dose for cumulative daily exposure over a lifetime, but for occasional use was well below concentrations associated with toxicity. This preliminary study suggests that serum concentrations of fluoride and silver after topical application of DSF should pose little toxicity risk when used in adults. NCT01664871.

  2. Short term serum pharmacokinetics of diammine silver fluoride after oral application

    PubMed Central

    2012-01-01

    Background There is growing interest in the use of diammine silver fluoride (DSF) as a topical agent to treat dentin hypersensitivity and dental caries as gauged by increasing published research from many parts of the world. While DSF has been available in various formulations for many years, most of its pharmacokinetic aspects within the therapeutic concentration range have never been fully characterized. Methods This preliminary study determined the applied doses (3 teeth treated), maximum serum concentrations, and time to maximum serum concentration for fluoride and silver in 6 adults over 4 h. Fluoride was determined using the indirect diffusion method with a fluoride selective electrode, and silver was determined using inductively coupled plasma-mass spectrometry. The mean amount of DSF solution applied to the 3 teeth was 7.57 mg (6.04 μL). Results Over the 4 hour observation period, the mean maximum serum concentrations were 1.86 μmol/L for fluoride and 206 nmol/L for silver. These maximums were reached 3.0 h and 2.5 h for fluoride and silver, respectively. Conclusions Fluoride exposure was below the U.S. Environmental Protection Agency (EPA) oral reference dose. Silver exposure exceeded the EPA oral reference dose for cumulative daily exposure over a lifetime, but for occasional use was well below concentrations associated with toxicity. This preliminary study suggests that serum concentrations of fluoride and silver after topical application of DSF should pose little toxicity risk when used in adults. Clinical trials registration NCT01664871. PMID:23272643

  3. Assessing gull abundance and food availability in urban parking lots

    USGS Publications Warehouse

    Clark, Daniel E.; Whitney, Jillian J.; MacKenzie, Kenneth G.; Koenen, Kiana K. G.; DeStefano, Stephen

    2015-01-01

    Feeding birds is a common activity throughout the world; yet, little is known about the extent of feeding gulls in urban areas. We monitored 8 parking lots in central Massachusetts, USA, during the fall and winter of 2011 to 2013 in 4 monitoring sessions to document the number of gulls present, the frequency of human–gull feeding interactions, and the effectiveness of signage and direct interaction in reducing human-provisioned food. Parking lots were divided between “education” and “no-education” lots. In education lots, we erected signs about problems caused when people feed birds and also asked people to stop feeding birds. We did not erect signs or ask people to stop feeding birds at no-education lots. We spent >1,200 hours in parking lots (range = 136 to 200 hours per parking lot), and gulls were counted every 20 minutes. We conducted >4,000 counts, and ring-billed gulls (Lorus delawarensis) accounted for 98% of all gulls. Our educational efforts were minimally effective. There were fewer feedings (P = 0.01) in education lots during one of the monitoring sessions but significantly more gulls (P = 0.008) in education lots during 2 monitoring sessions. While there was a marginal decrease (P = 0.055) in the number of feedings after no-education lots were transformed into education lots, there was no difference in gull numbers in these lots (P = 0.16). Education appears to have some influence in reducing the number of people feeding gulls, but our efforts were not able to reduce the number of human feeders or the amount of food enough to influence the number of gulls using parking lots.

  4. The contribution of lot-to-lot variation to the measurement uncertainty of an LC-MS-based multi-mycotoxin assay.

    PubMed

    Stadler, David; Sulyok, Michael; Schuhmacher, Rainer; Berthiller, Franz; Krska, Rudolf

    2018-05-01

    Multi-mycotoxin determination by LC-MS is commonly based on external solvent-based or matrix-matched calibration and, if necessary, the correction for the method bias. In everyday practice, the method bias (expressed as apparent recovery RA), which may be caused by losses during the recovery process and/or signal/suppression enhancement, is evaluated by replicate analysis of a single spiked lot of a matrix. However, RA may vary for different lots of the same matrix, i.e., lot-to-lot variation, which can result in a higher relative expanded measurement uncertainty (U r ). We applied a straightforward procedure for the calculation of U r from the within-laboratory reproducibility, which is also called intermediate precision, and the uncertainty of RA (u r,RA ). To estimate the contribution of the lot-to-lot variation to U r , the measurement results of one replicate of seven different lots of figs and maize and seven replicates of a single lot of these matrices, respectively, were used to calculate U r . The lot-to-lot variation was contributing to u r,RA and thus to U r for the majority of the 66 evaluated analytes in both figs and maize. The major contributions of the lot-to-lot variation to u r,RA were differences in analyte recovery in figs and relative matrix effects in maize. U r was estimated from long-term participation in proficiency test schemes with 58%. Provided proper validation, a fit-for-purpose U r of 50% was proposed for measurement results obtained by an LC-MS-based multi-mycotoxin assay, independent of the concentration of the analytes.

  5. 7 CFR 46.20 - Lot numbers.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 2 2011-01-01 2011-01-01 false Lot numbers. 46.20 Section 46.20 Agriculture... Receivers § 46.20 Lot numbers. An identifying lot number shall be assigned to each shipment of produce to be sold on consignment or joint account or for the account of another person or firm. A lot number should...

  6. 7 CFR 46.20 - Lot numbers.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 2 2013-01-01 2013-01-01 false Lot numbers. 46.20 Section 46.20 Agriculture... Receivers § 46.20 Lot numbers. An identifying lot number shall be assigned to each shipment of produce to be sold on consignment or joint account or for the account of another person or firm. A lot number should...

  7. 7 CFR 46.20 - Lot numbers.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 2 2014-01-01 2014-01-01 false Lot numbers. 46.20 Section 46.20 Agriculture... Receivers § 46.20 Lot numbers. An identifying lot number shall be assigned to each shipment of produce to be sold on consignment or joint account or for the account of another person or firm. A lot number should...

  8. 7 CFR 46.20 - Lot numbers.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 2 2012-01-01 2012-01-01 false Lot numbers. 46.20 Section 46.20 Agriculture... Receivers § 46.20 Lot numbers. An identifying lot number shall be assigned to each shipment of produce to be sold on consignment or joint account or for the account of another person or firm. A lot number should...

  9. 7 CFR 46.20 - Lot numbers.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 2 2010-01-01 2010-01-01 false Lot numbers. 46.20 Section 46.20 Agriculture... Receivers § 46.20 Lot numbers. An identifying lot number shall be assigned to each shipment of produce to be sold on consignment or joint account or for the account of another person or firm. A lot number should...

  10. Serum prolactin in coeliac disease: a marker for disease activity

    PubMed Central

    Reifen, R.; Buskila, D.; Maislos, M.; Press, J.; Lerner, A.

    1997-01-01

    Accepted 21 April 1997
 Prolactin, a polypeptide hormone of anterior pituitary origin, has pronounced physiological effects on growth, reproduction, and osmoregulation. Increasing evidence indicates that prolactin also has an immunomodulatory influence on the immune system. The status of prolactin in patients with coeliac disease was investigated by obtaining serum samples from 48 patients with active and non-active coeliac disease. These were compared with samples from 20 children with familial Mediterranean fever and 65 normal controls. Serum prolactin in patients with active coeliac disease was significantly higher than in the other groups studied and reference values. Serum prolactin correlated well with the degree of mucosal atrophy and with the serum concentration of antiendomysial antibodies. Prolactin may play a part in immune modulation in the intestinal damage of coeliac disease and serve as a potential marker for disease activity.

 PMID:9301358

  11. Elevation of serum CA 125 and D-dimer levels associated with rupture of ovarian endometrioma.

    PubMed

    Uharcek, P; Mlyncek, M; Ravinger, J

    2007-01-01

    Patients with endometriosis rarely have a serum CA 125 concentration >100 IU/mL. A raised plasma level of D-dimer indicates active fibrinolysis, either secondary to clot formation or primarily activated. This condition is seldom diagnosed in patients with endometriosis. A 53-year-old woman was referred to our institution for acute abdominal pain. Laparoscopic surgery revealed a large ovarian cyst with rupture on the left side. Preoperative laboratory tests detected high serum CA 125 and D-dimer levels. Adnexectomy was performed, resulting in a sharp decrease in serum CA 125 and D-dimer concentration. We describe the clinical course of the patient. Rupture of a large ovarian endometrioma can lead to a high serum concentration of CA 125, a condition which, in addition to the detected pelvic mass, may mimic a malignant process. The increased D-dimer plasma level indicated that a ruptured endometriotic cyst can induce coagulation reactions.

  12. Effects of long-term oral administration of levothyroxine sodium on serum thyroid hormone concentrations, clinicopathologic variables, and echocardiographic measurements in healthy adult horses.

    PubMed

    Frank, Nicholas; Buchanan, Benjamin R; Elliott, Sarah B

    2008-01-01

    To determine the effects of long-term oral levothyroxine sodium (L-T(4)) administration on serum thyroid hormone concentrations, thyroid gland function, clinicopathologic variables, and echocardiographic examination measurements in adult euthyroid horses. 6 healthy adult mares. Horses received L-T(4) (48 mg/d) orally for 48 weeks. Every 4 weeks, physical examinations were performed; blood samples were collected for CBC, plasma biochemical analyses, and assessments of serum total triiodothyronine (tT(3)) and thyroxine (tT(4)) concentrations. Plasma creatine kinase MB activity and cardiac troponin I concentration were also measured. Echocardiographic examinations were performed before and at 16, 32, and 48 weeks during the treatment period. During the treatment period, mean body weight decreased significantly; heart rate varied significantly, but the pattern of variation was not consistent. Significant time effects were detected for certain clinicopathologic variables, but mean values remained within reference ranges. Cardiac troponin I was only detectable in 8 of 24 plasma samples (concentration range, 0.01 to 0.03 ng/mL). Serum creatine kinase MB activity did not change significantly over time. Compared with the pretreatment value, 5.4-, 4.0-, and 3.7-fold increases in mean serum tT(4) concentrations were detected at 16, 32, and 48 weeks, respectively. Some cardiac measurements changed significantly over time, but mean values remained within published reference ranges. Mean fractional shortening was lower than the pretreatment mean value at 16 and 32 weeks. In horses, long-term oral administration of 48 mg of L-T(4)/d significantly increased serum tT(4) concentrations and did not appear to adversely affect health.

  13. Standardization of clinical enzyme analysis using frozen human serum pools with values assigned by the International Federation of Clinical Chemistry and Laboratory Medicine reference measurement procedures.

    PubMed

    Tong, Qing; Chen, Baorong; Zhang, Rui; Zuo, Chang

    Variation in clinical enzyme analysis, particularly across different measuring systems and laboratories, represents a critical but long-lasting problem in diagnosis. Calibrators with traceability and commutability are imminently needed to harmonize analysis in laboratory medicine. Fresh frozen human serum pools were assigned values for alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT), creatine kinase (CK) and lactate dehydrogenase (LDH) by six laboratories with established International Federation of Clinical Chemistry and Laboratory Medicine reference measurement procedures. These serum pools were then used across 76 laboratories as a calibrator in the analysis of five enzymes. Bias and imprecision in the measurement of the five enzymes tested were significantly reduced by using the value-assigned serum in analytical systems with open and single-point calibration. The median (interquartile range) of the relative biases of ALT, AST, GGT, CK and LDH were 2.0% (0.6-3.4%), 0.8% (-0.8-2.3%), 1.0% (-0.5-2.0%), 0.2% (-0.3-1.0%) and 0.2% (-0.9-1.1%), respectively. Before calibration, the interlaboratory coefficients of variation (CVs) in the analysis of patient serum samples were 8.0-8.2%, 7.3-8.5%, 8.1-8.7%, 5.1-5.9% and 5.8-6.4% for ALT, AST, GGT, CK and LDH, respectively; after calibration, the CVs decreased to 2.7-3.3%, 3.0-3.6%, 1.6-2.1%, 1.8-1.9% and 3.3-3.5%, respectively. The results suggest that the use of fresh frozen serum pools significantly improved the comparability of test results in analytical systems with open and single-point calibration.

  14. 78 FR 51742 - Notice of Proposed Withdrawal and Opportunity for Public Meeting; California

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-21

    ..., inclusive, and SE\\1/ 4\\NE\\1/4\\; sec. 26, lots 11, 12, and 13, S\\1/2\\SE\\1/4\\NE\\1/4\\, and N\\1/ 2\\NE\\1/4\\SE\\1/4..., lots 13 to 16, inclusive, and 18 to 22, inclusive, and a portion of lot 8 as described in the Donation... platted. sec. 19, lots 11, 13, and 16 to 19, inclusive; sec. 20, lot 4; sec. 29, lots 7 and 11; sec. 32...

  15. Lot-to-lot consistency of a tetravalent dengue vaccine in healthy adults in Australia: a randomised study.

    PubMed

    Torresi, Joseph; Heron, Leon G; Qiao, Ming; Marjason, Joanne; Chambonneau, Laurent; Bouckenooghe, Alain; Boaz, Mark; van der Vliet, Diane; Wallace, Derek; Hutagalung, Yanee; Nissen, Michael D; Richmond, Peter C

    2015-09-22

    The recombinant yellow fever-17D-dengue virus, live, attenuated, tetravalent dengue vaccine (CYD-TDV) has undergone extensive clinical trials. Here safety and consistency of immunogenicity of phase III manufacturing lots of CYD-TDV were evaluated and compared with a phase II lot and placebo in a dengue-naïve population. Healthy 18-60 year-olds were randomly assigned in a 3:3:3:3:1 ratio to receive three subcutaneous doses of either CYD-TDV from any one of three phase III lots or a phase II lot, or placebo, respectively in a 0, 6, 12 month dosing schedule. Neutralising antibody geometric mean titres (PRNT50 GMTs) for each of the four dengue serotypes were compared in sera collected 28 days after the third vaccination-equivalence among lots was demonstrated if the lower and upper limits of the two-sided 95% CIs of the GMT ratio were ≥0.5 and ≤2.0, respectively. 712 participants received vaccine or placebo and 614 (86%) completed the study; 17 (2.4%) participants withdrew after adverse events. Equivalence of phase III lots was demonstrated for 11 of 12 pairwise comparisons. One of three comparisons for serotype 2 was not statistically equivalent. GMTs for serotype 2 in phase III lots were close to each other (65.9, 44.1 and 58.1, respectively). Phase III lots can be produced in a consistent manner with predictable immune response and acceptable safety profile similar to previously characterised phase II lots. The phase III lots may be considered as not clinically different as statistical equivalence was shown for serotypes 1, 3 and 4 across the phase III lots. For serotype 2, although equivalence was not shown between two lots, the GMTs observed in the phase III lots were consistently higher than those for the phase II lot. As such, in our view, biological equivalence for all serotypes was demonstrated. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  16. Lipid composition of leprosy-derived corynebacteria, a distinct group of corynebacteria, and of a reference Corynebacterium.

    PubMed

    Gailly, C; David, F; Sandra, P; Laneelle, M A; Cocito, C

    1993-01-01

    Leprosy-derived corynebacteria (LDC) are diphtheroid organisms isolated from leprosy patients and previously characterized by DNA and cell wall analysis. Three groups of LDC components of taxonomic value, glycolipids, and phospholipids and cell-wall-bound lipids were analyzed in comparison with those of a reference strain C. hoffmannii (CH). The main CH glycolipid, "cord factor" (trehalose dimycolate), was missing from LDC. Among phospholipids, phosphatidylinositol and phosphatidylglycerol had lowered proportions in LDC, as compared to CH, whereas phosphatidylethanolamine and cardiolipin were absent from both microorganisms. Bound lipids in acidic extracts of delipidated LDC yielded arabinose corynomycolate in lesser quantity with respect to CH. Alkaline hydrolysis of whole cells released fatty acids and mycolic acids, which were analyzed by gas chromatography/mass spectrometry. Reference CH, grown in the absence of serum, yielded C16:0 and C18:1 (major) and C18:0 (minor) fatty acids, as well as C32, C34, and C36 corynomycolic acids. All these components, particularly mycolates, had lowered proportions when this organism was grown in the presence of serum. Dominant LDC components were, in addition to C16:0, C18:0, and CI8:u fatty acids, cholesterol from serum. Very low concentrations of corynomycolic acids with a high degree of unsaturation were found in these organisms, suggesting a dependence of lipid metabolism on growth conditions. The presence in LDC of tuberculostearic acid (C19r:0), a mycobacterial component found in some pathogenic corynebacteria, was carefully explored: Traces of C19r:0 were found in LDC 19 grown in the presence of delipidated serum, but not in LDC 15 nor in C. hoffmannii. Present data, in conjunction with previous studies on DNA and mycolic acids, disclose basic differences in the composition of LDC and conventional corynebacteria.

  17. Serum thyroid stimulating hormone, total and free T4 during the neonatal period: Establishing regional reference intervals

    PubMed Central

    Sheikhbahaei, Sara; Mahdaviani, Behnaz; Abdollahi, Alireza; Nayeri, Fatemeh

    2014-01-01

    Context: Congenital hypothyroidism (CH), the most common etiology of preventable mental retardation in children, is estimated to be more prevalent among Asian population. Aims: Since thyroid function tests (TFTs) varied among different ages and geographical regions, in this study, the neonatal thyroid reference intervals in a healthy neonatal population is determined for the first time in Iran. Settings and Design: A cross-sectional study performed on 246 healthy term newborns aged between 2 days and 1 month. Materials and Methods: Blood samples were obtained by venipuncture from all subjects. The median, 2.5th, 5th, 95th, and 97.5th percentile of serum thyroid-stimulating hormone (TSH), as well as the total and free T4 were assessed among different age groups. Statistical Analysis Used: Predictive Analytics Software (PASW Statistics 18) was used for the analysis. Results: Serum TSH, total and free T4 concentration peaked in 5th to 7th days of life, continued over 2 weeks, then decreased and started reaching to adult reference range. A significant negative correlation between age and serum concentration of TSH (P = 0.02), total T4 (P = 0.01) and free T4 (P = 0.01) was found. Conclusion: This study yielded fairly different values for TFTs compared compared values found in other countries and also different from values reported for laboratory kits we used. These differences were assumed to be due to variations in ethnicity, age, and laboratory methods used. Due to the lack of international standardization, conducting multicenter studies helps in making a more precise evaluation of thyroid status in neonates. PMID:24701428

  18. Reference values for serum leptin in healthy non-obese children and adolescents.

    PubMed

    Lausten-Thomsen, Ulrik; Christiansen, Michael; Louise Hedley, Paula; Esmann Fonvig, Cilius; Stjernholm, Theresa; Pedersen, Oluf; Hansen, Torben; Holm, Jens-Christian

    2016-11-01

    Adipokines are biologically active, low-molecular weight peptides, which play a major role in metabolic homeostasis in humans. Leptin has gained increasing attention in pediatrics as a biomarker for various metabolic pathologies. Yet, its usefulness is hampered by the relative lack of reference values from pediatric settings. Accordingly, this study aims to evaluate serum concentrations of leptin, soluble leptin receptor (sOB-R), and free leptin index (FLI) in healthy Danish schoolchildren aged 6-18 years and subsequently to establish reference intervals across sex and age groups. A total of 1193 healthy, non-obese Danish schoolchildren (730 girls, 463 boys) aged 6-18 years (median 11.9) were examined by trained medical staff. Serum leptin and sOB-R concentrations in venous fasting blood samples were quantitated by immunoassay. Percentile curves of leptin, sOB-R, and free leptin index were calculated using the General Additive Model for Location Scale and Shape (GAMLSS). Significant age and sex-dependent differences in circulating leptin levels were found. In boys, the median leptin concentration for all ages combined was 3.35 μg/L (95%-interval: 0.71-22.47) and in girls, it was 9.89 ng/L (95%-interval: 2.06-41.49). For SOB-R, no sex-specific difference was found, and the median sOB-R concentration was 8.24 μg/L (IQR: 3.58-23.74; range: < 1.56-744.15). We demonstrated an age-dependent correlation with both serum leptin concentration and free leptin index with a gradual and significant increase in girls throughout childhood and adolescence and a significantly higher leptin concentration and free leptin index bell-shaped peak in early adolescence in boys.

  19. AFRRI Reports, First Quarter 1993

    DTIC Science & Technology

    1993-05-01

    Oncology, Southern Califbrnia Sonw oifI these dlifferenles a rt: t hat, !or these Ia te Cancer Research Labo~ratory, U1Tniversity of’Southern Calilor- (fetp...acid WXR- 1065, lot BK 71 365 vas ob~taine’d fro nt I ndependently, the protective efh(’cts tof ’AR-151326 the )i~vision of’ Cancer Treatmniit...ion nttr one drn ativ kithbi . Cancer Rewarrauh. 45, 5-3 79-538 1. References ti’.~PRATNOr C~., 198.51h. ’’llre radii rotiriie~t’ r XVRI 065 Reeecsred

  20. Towards telecommunication payloads with photonic technologies

    NASA Astrophysics Data System (ADS)

    Vono, S.; Di Paolo, G.; Piccinni, M.; Pisano, A.; Sotom, M.; Aveline, M.; Ginestet, P.

    2017-11-01

    In the last decade, Thales Alenia Space has put a lot of its research effort on Photonic Technologies for Space Application with the aim to offer the market satellite telecommunication systems better performance and lower costs. This research effort has been concentrated on several activities, some of them sponsored by ESA. Most promising applications refer to Payload Systems. In particular, photonic payload applications have been investigated through the following two ESA studies: Artes-1 "Next Generation Telecommunication Payloads based on Photonic Technologies" and Artes-5 "OWR - Optical Wideband Receiver" activities.

  1. 7 CFR 983.152 - Failed lots/rework procedure.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 8 2012-01-01 2012-01-01 false Failed lots/rework procedure. 983.152 Section 983.152..., ARIZONA, AND NEW MEXICO Rules and Regulations § 983.152 Failed lots/rework procedure. (a) Inshell rework... the lot has been reworked and tested, it fails the aflatoxin test for a second time, the lot may be...

  2. 7 CFR 983.152 - Failed lots/rework procedure.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 8 2013-01-01 2013-01-01 false Failed lots/rework procedure. 983.152 Section 983.152..., ARIZONA, AND NEW MEXICO Rules and Regulations § 983.152 Failed lots/rework procedure. (a) Inshell rework... the lot has been reworked and tested, it fails the aflatoxin test for a second time, the lot may be...

  3. 7 CFR 983.152 - Failed lots/rework procedure.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 8 2011-01-01 2011-01-01 false Failed lots/rework procedure. 983.152 Section 983.152..., ARIZONA, AND NEW MEXICO Rules and Regulations § 983.152 Failed lots/rework procedure. (a) Inshell rework... the lot has been reworked and tested, it fails the aflatoxin test for a second time, the lot may be...

  4. 7 CFR 983.152 - Failed lots/rework procedure.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 8 2014-01-01 2014-01-01 false Failed lots/rework procedure. 983.152 Section 983.152..., ARIZONA, AND NEW MEXICO Rules and Regulations § 983.152 Failed lots/rework procedure. (a) Inshell rework... the lot has been reworked and tested, it fails the aflatoxin test for a second time, the lot may be...

  5. Establishment of Biological Reference Intervals and Reference Curve for Urea by Exploratory Parametric and Non-Parametric Quantile Regression Models.

    PubMed

    Sarkar, Rajarshi

    2013-07-01

    The validity of the entire renal function tests as a diagnostic tool depends substantially on the Biological Reference Interval (BRI) of urea. Establishment of BRI of urea is difficult partly because exclusion criteria for selection of reference data are quite rigid and partly due to the compartmentalization considerations regarding age and sex of the reference individuals. Moreover, construction of Biological Reference Curve (BRC) of urea is imperative to highlight the partitioning requirements. This a priori study examines the data collected by measuring serum urea of 3202 age and sex matched individuals, aged between 1 and 80 years, by a kinetic UV Urease/GLDH method on a Roche Cobas 6000 auto-analyzer. Mann-Whitney U test of the reference data confirmed the partitioning requirement by both age and sex. Further statistical analysis revealed the incompatibility of the data for a proposed parametric model. Hence the data was non-parametrically analysed. BRI was found to be identical for both sexes till the 2(nd) decade, and the BRI for males increased progressively 6(th) decade onwards. Four non-parametric models were postulated for construction of BRC: Gaussian kernel, double kernel, local mean and local constant, of which the last one generated the best-fitting curves. Clinical decision making should become easier and diagnostic implications of renal function tests should become more meaningful if this BRI is followed and the BRC is used as a desktop tool in conjunction with similar data for serum creatinine.

  6. Coal-tar-based pavement sealants—a potent source of PAHs

    USGS Publications Warehouse

    Mahler, Barbara J.; Van Metre, Peter C.

    2017-01-01

    P avement sealants are applied to the asphalt pavement of many parking lots, driveways, and even playgrounds in North America (Figure 1), where, when first applied, they render the pavement glossy black and looking like new. Sealant products used commercially in the central, eastern, and northern United States typically are coal-tarbased, whereas those used in the western United States typically are asphalt-based. Although the products look similar, they are chemically different. Coal-tarbased pavement sealants typically are 25-35 percent (by weight) coal tar or coal-tar pitch, materials that are known human carcinogens and that contain high concentrations of polycyclic aromatic hydrocarbons (PAHs) and related chemicals (unless otherwise noted, all Figure 1. Pavement sealant is commonly used to seal parking lots, playgrounds, and driveways throughout the United States. Sealants used in the central, northern, eastern, and southern United States typically contain coal tar or coal-tar pitch, both of which are known human carcinogens. Photos by the U.S. Geological Survey. data in this article are from Mahler et al. 2012 and references therein).

  7. A novel method for the elaboration of hydroxyapatite with high purity by sol-gel using the albumin and comparison with the classical methods

    NASA Astrophysics Data System (ADS)

    Mohammed, Eddya; Bouazza, Tbib; Khalil, El-Hami

    2018-02-01

    In this paper, we report the first synthesis of hydroxyapatite (Hap) by sol-gel using the albumin (egg white) compared with the four classical elaboration methods such as co-precipitation, solid state, and solid-liquid samples of hydroxyapatite. We use a reference sample of hydroxyapatite bought from Fluka Chemika company (Lot and Filling code 385330/1 14599). All samples are characterized by X-ray diffraction (XRD), Uv-visible spectroscopy (Uv-Vis), and Fourier transforms infrared spectroscopy (FT-IR). The XRD study showed the existence of a Hexagonal phase for all our samples prepared in our laboratory and an orthorhombic phase for the Fulka Chemika sample of Hap (Lot and Filling code 385330/1 14599). The study by Uv-visible spectroscopy was performed to determine and compare the optical gap and the disorder of each sample of Hap. The FT-IR spectroscopy demonstrated that all our Hap samples had a similar mode of vibration of the chemical bonds (OH-) and (PO4)3-.

  8. C-reactive protein reference percentiles among pre-adolescent children in Europe based on the IDEFICS study population.

    PubMed

    Schlenz, H; Intemann, T; Wolters, M; González-Gil, E M; Nappo, A; Fraterman, A; Veidebaum, T; Molnar, D; Tornaritis, M; Sioen, I; Mårild, S; Iacoviello, L; Ahrens, W

    2014-09-01

    C-reactive protein (CRP) is involved in a wide range of diseases. It is a powerful marker for inflammatory processes used for diagnostic and monitoring purposes. We aimed to establish reference values as data on the distribution of serum CRP levels in young European children are scarce. Reference values of high-sensitivity CRP concentrations were calculated for 9855 children aged 2.0-10.9 years, stratified by age and sex. The children were recruited during the population-based European IDEFICS study (Identification and prevention of Dietary- and lifestyle-induced health Effects in Children and infantS) with 18 745 participants recruited from 2007 to 2010. In 44.1% of the children, CRP values were below or equal the detection limit of 0.2 mg/l. Median CRP concentrations showed a slight negative age trend in boys and girls, whereas serum CRP values were slightly higher in girls than in boys across all age groups. Our population-based reference values of CRP may guide paediatric practice as elevated values may require further investigation or treatment. Therefore, the presented reference values represent a basis for clinical evaluation and for future research on risk assessment of diseases associated with increased CRP levels among children.

  9. Correlation between the Severity and Type of Acne Lesions with Serum Zinc Levels in Patients with Acne Vulgaris

    PubMed Central

    Rostami Mogaddam, Majid; Safavi Ardabili, Nastaran; Soflaee, Maedeh

    2014-01-01

    Acne vulgaris is the most common cutaneous disorder affecting adolescents and young adults. Some studies have reported an association between serum zinc levels and acne vulgaris. We aimed to evaluate the serum zinc level in patients with acne vulgaris and compare it with healthy controls. One hundred patients with acne vulgaris and 100 healthy controls were referred to our clinic. Acne severity was classified according to Global Acne Grading System (GAGS). Atomic absorption spectrophotometry was used to measure serum zinc levels. Mean serum level of zinc in acne patients and controls was 81.31 ± 17.63 μg/dl and 82.63 ± 17.49 μg/dl, respectively. Although the mean serum zinc level was lower in acne group, it was not statistically significant (P = 0.598). There was a correlation between serum zinc levels with severity and type of acne lesions. The results of our study suggest that zinc levels may be related to the severity and type of acne lesions in patients with acne vulgaris. Relative decrease of serum zinc level in acne patients suggests a role for zinc in the pathogenesis of acne vulgaris. PMID:25157359

  10. Correlation between the severity and type of acne lesions with serum zinc levels in patients with acne vulgaris.

    PubMed

    Rostami Mogaddam, Majid; Safavi Ardabili, Nastaran; Maleki, Nasrollah; Soflaee, Maedeh

    2014-01-01

    Acne vulgaris is the most common cutaneous disorder affecting adolescents and young adults. Some studies have reported an association between serum zinc levels and acne vulgaris. We aimed to evaluate the serum zinc level in patients with acne vulgaris and compare it with healthy controls. One hundred patients with acne vulgaris and 100 healthy controls were referred to our clinic. Acne severity was classified according to Global Acne Grading System (GAGS). Atomic absorption spectrophotometry was used to measure serum zinc levels. Mean serum level of zinc in acne patients and controls was 81.31 ± 17.63 μg/dl and 82.63 ± 17.49 μg/dl, respectively. Although the mean serum zinc level was lower in acne group, it was not statistically significant (P = 0.598). There was a correlation between serum zinc levels with severity and type of acne lesions. The results of our study suggest that zinc levels may be related to the severity and type of acne lesions in patients with acne vulgaris. Relative decrease of serum zinc level in acne patients suggests a role for zinc in the pathogenesis of acne vulgaris.

  11. Statistical distribution of building lot frontage: application for Tokyo downtown districts

    NASA Astrophysics Data System (ADS)

    Usui, Hiroyuki

    2018-03-01

    The frontage of a building lot is the determinant factor of the residential environment. The statistical distribution of building lot frontages shows how the perimeters of urban blocks are shared by building lots for a given density of buildings and roads. For practitioners in urban planning, this is indispensable to identify potential districts which comprise a high percentage of building lots with narrow frontage after subdivision and to reconsider the appropriate criteria for the density of buildings and roads as residential environment indices. In the literature, however, the statistical distribution of building lot frontages and the density of buildings and roads has not been fully researched. In this paper, based on the empirical study in the downtown districts of Tokyo, it is found that (1) a log-normal distribution fits the observed distribution of building lot frontages better than a gamma distribution, which is the model of the size distribution of Poisson Voronoi cells on closed curves; (2) the statistical distribution of building lot frontages statistically follows a log-normal distribution, whose parameters are the gross building density, road density, average road width, the coefficient of variation of building lot frontage, and the ratio of the number of building lot frontages to the number of buildings; and (3) the values of the coefficient of variation of building lot frontages, and that of the ratio of the number of building lot frontages to that of buildings are approximately equal to 0.60 and 1.19, respectively.

  12. Serum and Plasma Cholinesterase Activity in the Cape Griffon Vulture (Gyps coprotheres).

    PubMed

    Naidoo, Vinny; Wolter, Kerri

    2016-04-28

    Vulture (Accipitridae) poisonings are a concern in South Africa, with hundreds of birds dying annually. Although some of these poisonings are accidental, there has been an increase in the number of intentional baiting of poached rhinoceros (Rhinocerotidae) and elephant (Elephantidae) carcasses to kill vultures that alert officials to poaching sites by circling overhead. The primary chemicals implicated are the organophosphorous and carbamate compounds. Although most poisoning events can be identified by dead vultures surrounding the scavenged carcass, weak birds are occasionally found and brought to rehabilitation centers for treatment. The treating veterinarian needs to make an informed decision on the cause of illness or poisoning prior to treatment. We established the reference interval for serum and plasma cholinesterase activity in the Cape Griffon Vulture ( Gyps coprotheres ) as 591.58-1,528.26 U/L, providing a clinical assay for determining potential exposure to cholinesterase-depressing pesticides. Both manual and automated samplers were used with the butyrylthiocholine method. Species reference intervals for both serum and plasma cholinesterase showed good correlation and manual and automated measurements yielded similar results.

  13. Evaluation of serum lysyl oxidase as a blood test for colorectal cancer.

    PubMed

    Ward, S T; Weston, C J; Hepburn, E; Damery, S; Hejmadi, R K; Morton, D G; Middleton, G; Ismail, T; Adams, D H

    2014-06-01

    Lysyl oxidase (LOX) expression is elevated in colorectal cancer (CRC) tissue and associated with disease progression. A blood test may form a more acceptable diagnostic test for CRC although LOX has not previously been measured in the serum. We therefore sought to determine the clinical usefulness of a serum LOX test for CRC in a symptomatic population. Adult patients referred to a hospital colorectal clinic with bowel symptoms completed a questionnaire and provided a blood sample for serum LOX measurement. Associations between presenting symptoms, serum LOX concentrations and outcomes of investigations were tested by univariate and multivariate analyses to determine if serum LOX was clinically useful in the prediction of CRC. LOX expression in CRC and adjacent colon biopsies was evaluated by ELISA and immunohistochemistry. Thirty-one cases of colorectal cancer and 16 high-risk polyps were identified from a total of 962 participants. There was no association between serum LOX concentration and the presence of CRC, high-risk polyps or cancers at any site. LOX expression was significantly increased in CRC tissue compared to adjacent colon. Despite overexpression of LOX in CRC tissue, elevated serum levels could not be demonstrated. Serum LOX measurement is therefore not a clinically useful test for CRC. Copyright © 2013 Elsevier Ltd. All rights reserved.

  14. Glycerophosphate does not interact with components of parenteral nutrition.

    PubMed

    Topp, Heinrich; Hochfeld, Olena; Bark, Staffan; Grossmann, Matthias; Joukhadar, Christian; Westphal, Martin; Straatsma, Harald; Rothenburger, Markus

    2011-01-01

    The primary objective of this study was to determine and compare the pharmacokinetic (PK) profiles of inorganic phosphate in the serum after continuous administration of pure glycerophosphate and glycerophosphate contained in total parenteral nutrition (TPN) emulsions. This approach was selected to identify potential PK interactions between TPN components and glycerophosphate. The serum PK profile of inorganic phosphate after continuous intravenous administration of a sodium glycerophosphate containing TPN emulsion was determined in 10 healthy, white (5 male/5 female) volunteers. A pure sodium glycerophosphate formulation served as reference. Standard criteria of bioequivalence were applied. Subjects were enrolled in the double-blinded study and were randomly allocated to receive the test and reference preparations on two occasions in a 2-sequence crossover study design. The volunteers received 1/3 of the maximum recommended body weight- (BW) adjusted intravenous daily dosage (13.3 ml/kg BW) of the test drug over a period of 8 h. The amount of total phosphate (0.101 mmol/kg) and duration of administration were identical for the test and reference drugs. Study days were separated by washout periods of at least 88 h. Serum concentrations of total inorganic phosphate were measured serially over a 36-hour period using a validated method. A statistical mixed ANOVA, based on population averages, was used for testing bioequivalence between these study preparations. The 90% confidence intervals (90% CIs) of inorganic phosphate in serum were calculated for the test/reference ratios of the area under the time-concentration curve from time 0 to 36 h (AUC₀₋₃₆), the maximum concentration (C(max)) and the concentration 5 min before the end of infusion (C(ss)) for a bioequivalence range from 0.80 to 1.25. The mean test/reference ratios fell completely within the 90% CIs with values of 1.016 (90% CI 1.005-1.028), 1.013 (90% CI 0.981-1.047) and 0.932 (90% CI 0.886-0.980) for AUC(0-36), C(max) and C(ss), respectively. In total, 3 mild adverse events in the reference group were detected after starting intravenous infusion, while no adverse events were observed in the test group after treatment. Primary PK parameters were within the defined bioequivalence range of 0.8-1.25. Thus, inorganic phosphate levels were essentially similar between the two investigational medicinal products tested in the present study. These findings confirm the concept that nutritional components of the test drug do not significantly interact with glycerophosphate. The two study preparations proved to be safe during the investigation. Copyright © 2011 S. Karger AG, Basel.

  15. 76 FR 72469 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-23

    ...-lot'' order is an order for a quantity that is less than 100. A ``mixed-lot'' order is an order for a... mixed-lot order) are processed in the same manner as are round-lot orders, except (i) If an incoming odd... mixed-lot orders of HOLDRS in accordance with Rule 52.8, as described above. However, the prospectuses...

  16. Can “Cleaned and Greened” Lots Take on the Role of Public Greenspace?

    Treesearch

    Megan Heckert; Michelle Kondo

    2018-01-01

    Cities are increasingly greening vacant lots to reduce blight. Such programs could reduce inequities in urban greenspace access, but whether and how greened lots are used remains unclear. We surveyed three hundred greened lots in Philadelphia for signs of use and compared characteristics of used and nonused lots. We found physical signs of use that might be found in...

  17. The use of knowledge-based Genetic Algorithm for starting time optimisation in a lot-bucket MRP

    NASA Astrophysics Data System (ADS)

    Ridwan, Muhammad; Purnomo, Andi

    2016-01-01

    In production planning, Material Requirement Planning (MRP) is usually developed based on time-bucket system, a period in the MRP is representing the time and usually weekly. MRP has been successfully implemented in Make To Stock (MTS) manufacturing, where production activity must be started before customer demand is received. However, to be implemented successfully in Make To Order (MTO) manufacturing, a modification is required on the conventional MRP in order to make it in line with the real situation. In MTO manufacturing, delivery schedule to the customers is defined strictly and must be fulfilled in order to increase customer satisfaction. On the other hand, company prefers to keep constant number of workers, hence production lot size should be constant as well. Since a bucket in conventional MRP system is representing time and usually weekly, hence, strict delivery schedule could not be accommodated. Fortunately, there is a modified time-bucket MRP system, called as lot-bucket MRP system that proposed by Casimir in 1999. In the lot-bucket MRP system, a bucket is representing a lot, and the lot size is preferably constant. The time to finish every lot could be varying depends on due date of lot. Starting time of a lot must be determined so that every lot has reasonable production time. So far there is no formal method to determine optimum starting time in the lot-bucket MRP system. Trial and error process usually used for it but some time, it causes several lots have very short production time and the lot-bucket MRP would be infeasible to be executed. This paper presents the use of Genetic Algorithm (GA) for optimisation of starting time in a lot-bucket MRP system. Even though GA is well known as powerful searching algorithm, however, improvement is still required in order to increase possibility of GA in finding optimum solution in shorter time. A knowledge-based system has been embedded in the proposed GA as the improvement effort, and it is proven that the improved GA has superior performance when used in solving a lot-bucket MRP problem.

  18. Statistical validation of reagent lot change in the clinical chemistry laboratory can confer insights on good clinical laboratory practice.

    PubMed

    Cho, Min-Chul; Kim, So Young; Jeong, Tae-Dong; Lee, Woochang; Chun, Sail; Min, Won-Ki

    2014-11-01

    Verification of new lot reagent's suitability is necessary to ensure that results for patients' samples are consistent before and after reagent lot changes. A typical procedure is to measure results of some patients' samples along with quality control (QC) materials. In this study, the results of patients' samples and QC materials in reagent lot changes were analysed. In addition, the opinion regarding QC target range adjustment along with reagent lot changes was proposed. Patients' sample and QC material results of 360 reagent lot change events involving 61 analytes and eight instrument platforms were analysed. The between-lot differences for the patients' samples (ΔP) and the QC materials (ΔQC) were tested by Mann-Whitney U tests. The size of the between-lot differences in the QC data was calculated as multiples of standard deviation (SD). The ΔP and ΔQC values only differed significantly in 7.8% of the reagent lot change events. This frequency was not affected by the assay principle or the QC material source. One SD was proposed for the cutoff for maintaining pre-existing target range after reagent lot change. While non-commutable QC material results were infrequent in the present study, our data confirmed that QC materials have limited usefulness when assessing new reagent lots. Also a 1 SD standard for establishing a new QC target range after reagent lot change event was proposed. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  19. 12 CFR 1011.20 - Unlawful sales practices-regulatory provisions.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... lot is suitable for a septic tank operation or there is reasonable assurance that the lot can be served by a central sewage system; (3) The lot is legally accessible; and (4) The lot is free from...

  20. 12 CFR 1011.20 - Unlawful sales practices-regulatory provisions.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... lot is suitable for a septic tank operation or there is reasonable assurance that the lot can be served by a central sewage system; (3) The lot is legally accessible; and (4) The lot is free from...

  1. 12 CFR 1011.20 - Unlawful sales practices-regulatory provisions.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... lot is suitable for a septic tank operation or there is reasonable assurance that the lot can be served by a central sewage system; (3) The lot is legally accessible; and (4) The lot is free from...

  2. Statistical assessment of DNA extraction reagent lot variability in real-time quantitative PCR

    USGS Publications Warehouse

    Bushon, R.N.; Kephart, C.M.; Koltun, G.F.; Francy, D.S.; Schaefer, F. W.; Lindquist, H.D. Alan

    2010-01-01

    Aims: The aim of this study was to evaluate the variability in lots of a DNA extraction kit using real-time PCR assays for Bacillus anthracis, Francisella tularensis and Vibrio cholerae. Methods and Results: Replicate aliquots of three bacteria were processed in duplicate with three different lots of a commercial DNA extraction kit. This experiment was repeated in triplicate. Results showed that cycle threshold values were statistically different among the different lots. Conclusions: Differences in DNA extraction reagent lots were found to be a significant source of variability for qPCR results. Steps should be taken to ensure the quality and consistency of reagents. Minimally, we propose that standard curves should be constructed for each new lot of extraction reagents, so that lot-to-lot variation is accounted for in data interpretation. Significance and Impact of the Study: This study highlights the importance of evaluating variability in DNA extraction procedures, especially when different reagent lots are used. Consideration of this variability in data interpretation should be an integral part of studies investigating environmental samples with unknown concentrations of organisms. ?? 2010 The Society for Applied Microbiology.

  3. Exploring reserve lots of Cymbopogon citratus, Aloysia citrodora and Thymus × citriodorus as improved sources of phenolic compounds.

    PubMed

    Rita, Ingride; Pereira, Carla; Barros, Lillian; Ferreira, Isabel C F R

    2018-08-15

    Given the increasing consumers demand for novelty, tea companies have been presenting new added value products such as reserve lots of aromatic plants. Herein, infusions from different lots of three aromatic plants were assessed in terms of phenolic composition (HPLC-DAD-ESI/MS) and antioxidant properties (reducing power, free radical scavenging and lipid peroxidation inhibition capacity). Cymbopogon citratus (C. citratus; main compound 5-O-caffeoylquinic acid) and Aloysia citrodora (A. citrodora; prevalence of verbascoside) reserve lots revealed higher phenolic compounds concentration than the respective standard lots. Thymus × citriodorus (T. citriodorus; main compound rosmarinic acid) standard lot presented higher amounts of phenolic acids than the reserve lot, nonetheless, total flavonoids and phenolic compounds were not significantly different. The differences between both lots antioxidant activity were more noticeable in C. citratus, with the reserve lot presenting the highest activity. This study provides evidence of the differences between these plants chemical composition and bioactivity depending on the harvesting conditions. Copyright © 2018 Elsevier Ltd. All rights reserved.

  4. Joint-use park-and-ride lots.

    DOT National Transportation Integrated Search

    1989-01-01

    Joint-use park-and-ride lots have proven successful in Virginia as well as other states. As expected, there are both positive and negative aspects of such lots; these are described in this report. In addition, information on incentives to lot owners,...

  5. Evaluation of lot-to-lot repeatability and effect of assay media choice in the recombinant Factor C assay.

    PubMed

    McKenzie, Jennifer Helen; Alwis, K Udeni; Sordillo, Joanne E; Kalluri, Kesava Srinivas; Milton, Donald Kirby

    2011-06-01

    Measurement of environmental endotoxin exposures is complicated by variability encountered using current biological assay methods arising in part from lot-to-lot variability of the Limulus-amebocyte lysate (LAL) reagents. Therefore, we investigated the lot-to-lot repeatability of commercially available recombinant Factor C (rFC) kits as an alternative to LAL. Specifically, we compared endotoxin estimates obtained from rFC assay of twenty indoor dust samples, using four different extraction and assay media, to endotoxin estimates previously obtained by Limulus amebocyte lysate (LAL) assay and amounts of 3-hydroxy fatty acids (3-OHFA) in lipopolysaccharide (LPS) using gas-chromatography mass spectroscopy (GC-MS). We found that lot-to-lot variability of the rFC assay kits does not significantly alter endotoxin estimates in house dust samples when performed using three of the four assay media tested and that choice of assay media significantly altered endotoxin estimates obtained by rFC assay of house dust samples. Our findings demonstrate lot-to-lot reproducibility of rFC assay of environmental samples and suggest that use of rFC assay performed with Tris buffer or water as the extraction and assay medium for measurement of endotoxin in dust samples may be a suitable choice for developing a standardized methodology.

  6. Carbamazepine-induced hyperammonemia.

    PubMed

    Adams, Erin N; Marks, Alla; Lizer, Mitsi H

    2009-08-15

    A case of carbamazepine-induced hyperammonemia is presented. A 26-year-old man with bipolar disorder, seizures, and mild mental retardation secondary to a traumatic brain injury began treatment with carbamazepine for aggression and seizure control. After three weeks of carbamazepine therapy, the patient arrived at the emergency department (ED) with severe agitation and aggressive behavior. His oral medications included topiramate, carbamazepine, olanzapine, quetiapine, guanfacine, and desmopressin acetate. The patient's medications had been stable for at least six months except for the addition of carbamazepine one month before his arrival at the ED. Upon admission, the patient's vital signs were found to be within normal limits, as were his liver profile results, complete blood count, thyroid-stimulating-hormone level, and serum chemistry panel. His serum carbamazepine concentration was 3.9 microg/mL (reference range, 4-12 microg/mL), and his serum ammonia concentration was 127 microg/dL (reference range, 19-60 microg/dL). Carbamazepine was discontinued upon admission, and the patient was treated with oral lactulose. Since carbamazepine was discontinued and had been prescribed for bipolar disorder, his olanzapine dosage was increased, and trazodone was added at bedtime for insomnia. Of note, the patient had been on carbamazepine therapy one year earlier and had experienced the same adverse event. He had also developed elevated serum ammonia levels while on valproic acid. The patient's serum ammonia level returned to normal by hospital day 4, and he was discharged to his group home. A 26-year-old man with bipolar disorder developed hyperammonemia three weeks after initiating carbamazepine therapy.

  7. The relationship between caregivers' subjective social status and asthma symptoms and management for urban children.

    PubMed

    Diep, Judy; Fagnano, Maria; Tremblay, Paul; Halterman, Jill S

    2018-03-01

    Subjective social status (SSS) is a person's perception of his/her social standing among others. We explored the relationship between caregivers' SSS and asthma symptoms, visits, and medication use among children with persistent asthma. We analyzed baseline data of children (3-10 years) from the SB-TEAM trial in Rochester, NY. Using a modified MacArthur Scale of SSS, caregivers rated themselves "a lot worse off" to "a lot better off" compared to 4 groups (e.g., neighbors). "Low SSS" was defined by a response of "a lot worse off" or "somewhat worse off" for any of the referent groups. Caregivers reported their child's asthma symptoms, healthcare visits for asthma, and medication use. Bivariate and multivariate statistics were used. We found that, of the 230 children enrolled (participation rate:78%, 62% Black, 72% Medicaid), 29% of caregivers had low SSS. Caregivers with low SSS had more depressive symptoms (46% vs. 28%) and lower social support (69.1 vs. 77.7). In multivariable analyses, children of caregivers with low SSS had fewer symptom-free days/2 weeks (5.8 vs. 7.9, p = .01). While they were more likely to have a routine asthma visit in the past year (35% vs. 23%, adjusted p = .03), there was no difference in their use of preventive medication. Many caregivers of children with persistent asthma report low SSS. While children of these caregivers had fewer symptom-free days, they were not more likely to use preventive medications. Efforts are needed to support these caregivers to ensure optimal preventive care and reduce morbidity.

  8. The Effects of Tissue-Nonspecific Alkaline Phosphatase Gene Therapy on Craniosynostosis and Craniofacial Morphology in the FGFR2C342Y/+ Mouse Model of Crouzon Craniosynostosis

    PubMed Central

    Wang, E; Nam, HK; Liu, J; Hatch, NE

    2015-01-01

    Objectives Craniosynostosis, the premature fusion of cranial bones, has traditionally been described as a disease of increased bone mineralization. However, multiple mouse models of craniosynostosis display craniosynostosis simultaneously with diminished cranial bone volume and/or density. We propose an alternative hypothesis that craniosynostosis results from abnormal tissue mineralization through the downregulation of tissue-nonspecific alkaline phosphatase (TNAP) enzyme downstream of activating mutations in FGFRs. Material & Methods Neonatal Crouzon (FGFRC342Y/+) and wild type (FGFR+/+) mice were injected with lentivirus to deliver a recombinant form of TNAP. Mice were sacrificed at four weeks post-natal. Serum was collected to test for alkaline phosphatase (AP), phosphorus, and calcium levels. Craniofacial bone fusion and morphology was assessed by micro-computed tomography. Results Injection with the TNAP lentivirus significantly increased serum AP levels (increased serum AP levels are indicative of efficient transduction and production of the recombinant protein), but results were variable and dependent upon viral lot and the litter of mice injected. Morphologic analysis revealed craniofacial form differences for inferior surface (p=.023) and cranial height (p=.014) regions between TNAP lentivirus injected and vehicle-injected Crouzon mice. With each unit increase in AP level, the odds of lambdoid suture fusion decreased by 84.2% and these results came close to statistical significance (p=.068). Conclusion These results suggest that TNAP deficiency may mediate FGFR2-associated craniosynostosis. Future studies should incorporate injection of recombinant TNAP protein, to avoid potential side effects and variable efficacy of lentiviral gene delivery. PMID:25865549

  9. Evaluation of a CLEIA automated assay system for the detection of a panel of tumor markers.

    PubMed

    Falzarano, Renato; Viggiani, Valentina; Michienzi, Simona; Longo, Flavia; Tudini, Silvestra; Frati, Luigi; Anastasi, Emanuela

    2013-10-01

    Tumor markers are commonly used to detect a relapse of disease in oncologic patients during follow-up. It is important to evaluate new assay systems for a better and more precise assessment, as a standardized method is currently lacking. The aim of this study was to assess the concordance between an automated chemiluminescent enzyme immunoassay system (LUMIPULSE® G1200) and our reference methods using seven tumor markers. Serum samples from 787 subjects representing a variety of diagnoses, including oncologic, were analyzed using LUMIPULSE® G1200 and our reference methods. Serum values were measured for the following analytes: prostate-specific antigen (PSA), alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), cancer antigen 125 (CA125), carbohydrate antigen 15-3 (CA15-3), carbohydrate antigen 19-9 (CA19-9), and cytokeratin 19 fragment (CYFRA 21-1). For the determination of CEA, AFP, and PSA, an automatic analyzer based on chemiluminescence was applied as reference method. To assess CYFRA 21-1, CA125, CA19-9, and CA15-3, an immunoradiometric manual system was employed. Method comparison by Passing-Bablok analysis resulted in slopes ranging from 0.9728 to 1.9089 and correlation coefficients from 0.9977 to 0.9335. The precision of each assay was assessed by testing six serum samples. Each sample was analyzed for all tumor biomarkers in duplicate and in three different runs. The coefficients of variation were less than 6.3 and 6.2 % for within-run and between-run variation, respectively. Our data suggest an overall good interassay agreement for all markers. The comparison with our reference methods showed good precision and reliability, highlighting its usefulness in clinical laboratory's routine.

  10. Management of Subclinical Hypothyroidism in Pregnancy: A Comment from the Italian Society of Endocrinology and the Italian Thyroid Association to the 2017 American Thyroid Association Guidelines-"The Italian Way".

    PubMed

    Rotondi, Mario; Chiovato, Luca; Pacini, Furio; Bartalena, Luigi; Vitti, Paolo

    2018-05-01

    The 2017 American Thyroid Association guidelines for the diagnosis and management of thyroid disease during pregnancy and the postpartum were published six years after the previous ones. They provide comprehensive clinical recommendations for the whole spectrum of thyroid diseases, as well as for optimal iodine intake during pregnancy, postpartum, and lactation. The present position statement mainly regards the recommended flow chart for therapeutic decision making in pregnant women being diagnosed with subclinical hypothyroidism. Here, we comment on the major biochemical and clinical situations and the corresponding therapeutic recommendations. In particular, we welcome the critical revision of the thyrotropin (TSH) reference range in pregnancy, and we agree that there is no need to treat thyroid peroxidase antibody-negative women with a serum TSH ranging from 2.5 μIU/mL to the upper limit of the reference range. This recommendation will hopefully reduce the huge proportion of healthy pregnant women in whom, according to the previous guidelines, levothyroxine therapy had to be initiated. On the other hand, we are concerned with the recommendation to only "consider treatment" in thyroid peroxidase antibody-negative pregnant women with a serum TSH ranging from the upper limit of the reference range to 10.0 μIU/mL. This is because thyroid antibodies may be falsely negative during gestation, and serum negative chronic autoimmune thyroiditis is a well-known clinical entity even outside pregnancy. Based on these and other arguments, we recommend treatment with levothyroxine in pregnant women with TSH levels ranging between the upper limit of the reference range and 10.0 μIU/mL independently from their thyroid antibody status.

  11. Lot-to-Lot Variability of Test Strips and Accuracy Assessment of Systems for Self-Monitoring of Blood Glucose according to ISO 15197

    PubMed Central

    Baumstark, Annette; Pleus, Stefan; Schmid, Christina; Link, Manuela; Haug, Cornelia; Freckmann, Guido

    2012-01-01

    Background Accurate and reliable blood glucose (BG) measurements require that different test strip lots of the same BG monitoring system provide comparable measurement results. Only a small number of studies addressing this question have been published. Methods In this study, four test strip lots for each of five different BG systems [Accu-Chek® Aviva (system A), FreeStyle Lite® (system B), GlucoCheck XL (system C), Pura™/mylife™ Pura (system D), and OneTouch® Verio™ Pro (system E)] were evaluated with procedures according to DIN EN ISO 15197:2003. The BG system measurement results were compared with the manufacturer’s measurement procedure (glucose oxidase or hexokinase method). Relative bias according to Bland and Altman and system accuracy according to ISO 15197 were analyzed. A BG system consists of the BG meter itself and the test strips. Results The maximum lot-to-lot difference between any two of the four evaluated test strip lots per BG system was 1.0% for system E, 2.1% for system A, 3.1% for system C, 6.9% for system B, and 13.0% for system D. Only two systems (systems A and B) fulfill the criteria of DIN EN ISO 15197:2003 with each test strip lot. Conclusions Considerable lot-to-lot variability between test strip lots of the same BG system was found. These variations add to other sources of inaccuracy with the specific BG system. Manufacturers should regularly and effectively check the accuracy of their BG meters and test strips even between different test strip lots to minimize risk of false treatment decisions. PMID:23063033

  12. Serum IGF-I and IGFBP-3 levels of Turkish children during childhood and adolescence: establishment of reference ranges with emphasis on puberty.

    PubMed

    Bereket, Abdullah; Turan, Serap; Omar, Anjumanara; Berber, Mustafa; Ozen, Ahmet; Akbenlioglu, Cengiz; Haklar, Goncagul

    2006-01-01

    We established age- and sex-related reference ranges for serum insulin-like growth factor-I (IGF-I) and insulin-like growth factor binding protein-3 (IGFBP-3) levels in 807 healthy Turkish children (428 boys, 379 girls), and constructed a model for calculation of standard deviation scores of IGF-I and IGFBP-3 according to age, sex and pubertal stage. Serum IGF-I and IGFBP-3 concentrations tended to be higher in girls compared to boys of the same ages, but the differences were statistically significant only in pubertal ages (9-14 years) for IGF-I and only in prepubertal ages for IGFBP-3 (6-8 years) (p < 0.05). Peak IGF-I concentrations were observed earlier in girls than boys (14 vs. 15 years, Tanner stage IV vs. V) starting to decline thereafter. IGFBP-3 levels peaked at age 13 and at Tanner stage IV in both sexes with a subsequent fall. Serum levels of IGF-I and IGFBP-3 increased steadily with age in the prepubertal stage followed by a rapid increase in IGF-I in the early pubertal stages. A relatively steeper increase in IGF-I but not in IGFBP-3 levels was observed at age 10-11 years in girls and at 12-13 years in boys which preceded the reported age of pubertal growth spurt. At late pubertal stages, both IGF-I and IGFBP-3 either did not change or decreased by increasing age. Interrelationships between growth factors and anthropometric measurements have been described, and the physiologic consequences of these have been discussed in detail. Differences in the pattern of IGF-I and IGFBP-3 in the present paper and those reported in other studies emphasize the importance of locally established reference ranges. Establishment of this reference data and a standard deviation score prediction model based on age, sex and puberty will enhance the diagnostic power and utility of IGF-I and IGFBP-3 in evaluating growth disorders in our population. Copyright 2006 S. Karger AG, Basel

  13. Comparison of different commercial ELISAs for detection of antibodies against porcine respiratory and reproductive syndrome virus in serum.

    PubMed

    Sattler, Tatjana; Wodak, Eveline; Revilla-Fernández, Sandra; Schmoll, Friedrich

    2014-12-18

    In recent years, several new ELISAs for the detection of antibodies against the porcine reproductive and respiratory disease virus (PRRSV) in pig serum have been developed. To interpret the results, specificity and sensitivity data as well as agreement to a reference ELISA must be available. In this study, three commercial ELISAs (INgezim PRRS 2.0 - ELISA II, Priocheck® PRRSV Ab porcine - ELISA III and CIVTEST suis PRRS E/S PLUS - ELISA IV, detecting PRRSV type 1 antibodies) were compared to a standard ELISA (IDEXX PRRS X3 Ab Test - ELISA I). The serum of three pigs vaccinated with an attenuated PRRSV live vaccine (genotype 2) was tested prior to and several times after the vaccination. Furthermore, serum samples of 245 pigs of PRRSV positive herds, 309 pigs of monitored PRRSV negative herds, 256 fatteners of assumed PRRSV negative herds with unknown herd history and 92 wild boars were tested with all four ELISAs. ELISAs II and III were able to detect seroconversion of vaccinated pigs with a similar reliability. According to kappa coefficient, the results showed an almost perfect agreement between ELISA I as reference and ELISA II and III (kappa > 0.8), and substantial agreement between ELISA I and ELISA IV (kappa = 0.71). Sensitivity of ELISA II, III and IV was 96.0%, 100% and 91.5%, respectively. The specificity of the ELISAs determined in samples of monitored PRRSV negative herds was 99.0%, 95.1% and 96.4%, respectively. In assumed negative farms that were not continually monitored, more positive samples were found with ELISA II to IV. The reference ELISA I had a specificity of 100% in this study. All tested ELISAs were able to detect a PRRSV positive herd. The specificity and sensitivity of the tested commercial ELISAs, however, differed. ELISA II had the highest specificity and ELISA III had the highest sensitivity in comparison to the reference ELISA. ELISA IV had a lower sensitivity and specificity than the other ELISAs.

  14. Concentrations of polycyclic aromatic hydrocarbons (PAHs) and major and trace elements in simulated rainfall runoff from parking lots, Austin, Texas, 2003

    USGS Publications Warehouse

    Mahler, Barbara J.; Van Metre, Peter C.; Wilson, Jennifer T.

    2004-01-01

    Samples of creek bed sediment collected near seal-coated parking lots in Austin, Texas, by the City of Austin during 2001–02 had unusually elevated concentrations of polycyclic aromatic hydrocarbons (PAHs). To investigate the possibility that PAHs from seal-coated parking lots might be transported to urban creeks, the U.S. Geological Survey, in cooperation with the City of Austin, sampled runoff and scrapings from four test plots and 13 urban parking lots. The surfaces sampled comprise coal-tar-emulsion-sealed, asphalt-emulsion-sealed, unsealed asphalt, and unsealed concrete. Particulates and filtered water in runoff and surface scrapings were analyzed for PAHs. In addition, particulates in runoff were analyzed for major and trace elements. Samples of all three media from coal-tar-sealed parking lots had concentrations of PAHs higher than those from any other types of surface. The mean total PAH concentration in particulates in runoff from parking lots in use were 3,500,000, 620,000, and 54,000 micrograms per kilogram from coal-tar-sealed, asphalt-sealed, and unsealed (asphalt and concrete combined) lots, respectively. The probable effect concentration sediment quality guideline is 22,800 micrograms per kilogram. The mean total PAH (sum of detected PAHs) concentration in filtered water from parking lots in use was 8.6 micrograms per liter for coal-tar-sealed lots; the one sample analyzed from an asphalt-sealed lot had a concentration of 5.1 micrograms per liter and the one sample analyzed from an unsealed asphalt lot was 0.24 microgram per liter. The mean total PAH concentration in scrapings was 23,000,000, 820,000, and 14,000 micrograms per kilogram from coal-tar-sealed, asphalt-sealed, and unsealed asphalt lots, respectively. Concentrations of lead and zinc in particulates in runoff frequently exceeded the probable effect concentrations, but trace element concentrations showed no consistent variation with parking lot surface type.

  15. Pedestrian and traffic safety in parking lots at SNL/NM : audit background report.

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Sanchez, Paul Ernest

    2009-03-01

    This report supplements audit 2008-E-0009, conducted by the ES&H, Quality, Safeguards & Security Audits Department, 12870, during fall and winter of FY 2008. The study evaluates slips, trips and falls, the leading cause of reportable injuries at Sandia. In 2007, almost half of over 100 of such incidents occurred in parking lots. During the course of the audit, over 5000 observations were collected in 10 parking lots across SNL/NM. Based on benchmarks and trends of pedestrian behavior, the report proposes pedestrian-friendly features and attributes to improve pedestrian safety in parking lots. Less safe pedestrian behavior is associated with older parkingmore » lots lacking pedestrian-friendly features and attributes, like those for buildings 823, 887 and 811. Conversely, safer pedestrian behavior is associated with newer parking lots that have designated walkways, intra-lot walkways and sidewalks. Observations also revealed that motorists are in widespread noncompliance with parking lot speed limits and stop signs and markers.« less

  16. Heuristic for Critical Machine Based a Lot Streaming for Two-Stage Hybrid Production Environment

    NASA Astrophysics Data System (ADS)

    Vivek, P.; Saravanan, R.; Chandrasekaran, M.; Pugazhenthi, R.

    2017-03-01

    Lot streaming in Hybrid flowshop [HFS] is encountered in many real world problems. This paper deals with a heuristic approach for Lot streaming based on critical machine consideration for a two stage Hybrid Flowshop. The first stage has two identical parallel machines and the second stage has only one machine. In the second stage machine is considered as a critical by valid reasons these kind of problems is known as NP hard. A mathematical model developed for the selected problem. The simulation modelling and analysis were carried out in Extend V6 software. The heuristic developed for obtaining optimal lot streaming schedule. The eleven cases of lot streaming were considered. The proposed heuristic was verified and validated by real time simulation experiments. All possible lot streaming strategies and possible sequence under each lot streaming strategy were simulated and examined. The heuristic consistently yielded optimal schedule consistently in all eleven cases. The identification procedure for select best lot streaming strategy was suggested.

  17. [Analysis of biochemical markers in serum of guinea pigs after death caused by hypothermia].

    PubMed

    Li, Shi-ying; Deng, Kai-fei; Shao, Yu; Li, Zheng-dong; Qin, Zhi-qiang; Chen, Yi-jiu; Huang, Ping

    2014-08-01

    To explore the changes and rules of biochemical markers in serum of guinea pigs after death caused by hypothermia and to provide references for fatal hypothermia diagnosis by serum biochemical markers. Twenty guinea pigs were randomly divided into experimental group and control group. The guinea pigs in the experimental group were kept at -30 °C until death, while the ones in control group were decapitated after same survival intervals at 25 °C. The serum was extracted from the whole blood of right ventricular immediately. Subsequently, a series of serum biochemical markers were analyzed by auto bio-chemical analyzer. The levels of glucose, uric acid, creatinine and urea nitrogen in the experimental group were significantly higher than those in control group, respectively (P<0.05). Compared with the control group, the levels of total protein and albumin were significantly lower in the experimental group (P<0.05). There were no significantly differences of the levels of other markers such as serum enzymes and ions observed between the two groups. There are characteristic changes of some specific serum biochemical markers in fatal hypothermia, which may be potentially useful for auxiliary diagnosis of fatal hypothermia.

  18. [Metabolic Characteristics of Lethal Bradycardia Induced by Myocardial Ischemia].

    PubMed

    Wu, J Y; Wang, D; Kong, J; Wang, X X; Yu, X J

    2017-02-01

    To explore the metabolic characteristics of lethal bradycardia induced by myocardial ischemia in rat's serum. A rat myocardial ischemia-bradycardia-sudden cardiac death (MI-B-SCD) model was established, which was compared with the sham-operation group. The metabolic profile of postmortem serum was analyzed by gas chromatography-mass spectrometry (GC-MS), coupled with the analysis of serum metabolic characteristics using metabolomics strategies. The serum metabolic profiles were significantly different between the MI-B-SCD rats and the control rats. Compared to the control rats, the MI-B-SCD rats had significantly higher levels of lysine, ornithine, purine, serine, alanine, urea and lactic acid; and significantly lower levels of succinate, hexadecanoic acid, 2-ketoadipic acid, glyceraldehyde, hexendioic acid and octanedioic acid in the serum. There were some correlations among different metabolites. There is obvious metabolic alterations in the serum of MI-B-SCD rat. Both lysine and purine have a high value in diagnosing MI-B-SCD. The results are expected to provide references for forensic and clinical applications of prevention and control of sudden cardiac death. Copyright© by the Editorial Department of Journal of Forensic Medicine

  19. Comparison of the extraction and determination of serum exosome and miRNA in serum and the detection of miR-27a-3p in serum exosome of ALS patients.

    PubMed

    Xu, Qian; Zhao, Yuying; Zhou, Xiaoyan; Luan, Jing; Cui, Yazhou; Han, Jinxiang

    2018-02-01

    Amyotrophic Lateral Sclerosis (ALS) is a muscle-bone degenerative disease, which lacks a specific index for diagnosis. In our previous studies, we found that exosomes mediated the interaction mechanism between muscle and bone at the cellular level, and myoblast exosomes can transfer miR-27a-3p to promote osteoblast mineralization. Therefore, we suppose that the expression of miR-27a-3p in the serum exosomes of ALS patients also changes. In this study, we used healthy human serum as a sample to find out the conditions and methods for extraction and detection. Then through comparison of the expression of miR-27a-3p in the serum exosomes of 10 ALS patients and healthy subjects, we found that in the ALS patients miR-27a-3p was down-regulated, and may be involved in the development of ALS, and therefore has potential as a reference for the diagnosis of ALS in the clinic.

  20. Reference intervals for serum lipids and prevalence of dyslipidaemia in 6-12-year-old children: The Health Oriented Pedagogical Project (HOPP).

    PubMed

    Strand, Martin Frank; Fredriksen, Per Morten; Hjelle, Ole Petter; Lindberg, Morten

    2018-05-01

    Elevated serum lipid concentrations in childhood are thought to be risk factors for the development of cardiovascular disease later in life. The present study aims to provide age- and gender-related reference intervals for total cholesterol (TC), high-density lipoprotein (HDL) cholesterol, and non-HDL cholesterol in healthy school children. We also investigated the prevalence of dyslipidaemia using the published criteria for these biomarkers. Venous blood and anthropometric data were collected from 1340 children in the HOPP study, aged between 6 and 12 years. Age- and gender-related reference intervals (2.5th and 97.5th percentiles) were established according to the IFCC recommendations, using the software RefVal 4.10. Gender differences were observed for total cholesterol and non-HDL cholesterol, but not for HDL cholesterol. Age differences were observed for total cholesterol. The reference intervals were in the range of 3.1-5.9 mmol/L for total cholesterol, 1.0-2.4 mmol/L for HDL cholesterol and 1.4-4.2 mmol/L for non-HDL cholesterol. Dyslipidaemia prevalence was as follows: increased TC 9.6%, decreased HDL 1.6%, and increased non-HDL 5.6%. Age- and gender-related reference intervals in a Norwegian population are similar to those reported in other countries. The prevalence of dyslipidaemia among Norwegian children is significant, emphasising the importance of appropriate reference intervals in clinical practice.

  1. Commercial radioimmunoassay for beta subunit of human chorionic gonadotropin: falsely positive determinations due to elevated serum luteinizing hormone

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Fowler, J.E. Jr.; Platoff, G.E.; Kubrock, C.A.

    1982-01-01

    Among 17 men who had received seemingly curative treatment for unilateral non-seminomatous germ cell tumors for the testis and who had consistently normal serum human chorionic gonadotropin (HCG) levels at a reference laboratory, 7 (41%) had at least one falsely positive commercial serum HCG determination. To investigate the cause of these falsely positive determinations the authors measured the cross reactivity of luteinizing hormone (LH) and follicle stimulating hormone (FSH) standards in the commercial HCG assay, and studied the relationships between commercial HCG levels and serum LH levels, serum FSH levels and gonadal status in men with and without normal gonadalmore » function. The falsely positive HCG determinations appeared to be due to elevated serum LH levels and cross reactivity of LH in the commercial HCG assay because: 1) there was substantial cross reactivity of the LH standards in the commercial assay, 2) the serum LH was elevated in four of six men with solitary testes, 3) there was a striking correlation between elevated serum LH levels and falsely elevated commercial HCG levels in ten men with solitary or absent testes, and 4) there were no falsely positive HCG determinations in 13 normal men but there were falsely positive HCG determinations in seven of ten anorchid men.« less

  2. 7 CFR 983.52 - Failed lots/rework procedure.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 8 2013-01-01 2013-01-01 false Failed lots/rework procedure. 983.52 Section 983.52..., ARIZONA, AND NEW MEXICO Regulations § 983.52 Failed lots/rework procedure. (a) Substandard pistachios... committee may establish, with the Secretary's approval, appropriate rework procedures. (b) Failed lot...

  3. 7 CFR 983.52 - Failed lots/rework procedure.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 8 2012-01-01 2012-01-01 false Failed lots/rework procedure. 983.52 Section 983.52..., ARIZONA, AND NEW MEXICO Regulations § 983.52 Failed lots/rework procedure. (a) Substandard pistachios... committee may establish, with the Secretary's approval, appropriate rework procedures. (b) Failed lot...

  4. 7 CFR 983.52 - Failed lots/rework procedure.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 8 2014-01-01 2014-01-01 false Failed lots/rework procedure. 983.52 Section 983.52..., ARIZONA, AND NEW MEXICO Regulations § 983.52 Failed lots/rework procedure. (a) Substandard pistachios... committee may establish, with the Secretary's approval, appropriate rework procedures. (b) Failed lot...

  5. 7 CFR 29.35 - Lot seal.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 2 2010-01-01 2010-01-01 false Lot seal. 29.35 Section 29.35 Agriculture Regulations of the Department of Agriculture AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing... INSPECTION Regulations Definitions § 29.35 Lot seal. A seal approved by the Director for sealing lots of...

  6. 7 CFR 29.35 - Lot seal.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 2 2011-01-01 2011-01-01 false Lot seal. 29.35 Section 29.35 Agriculture Regulations of the Department of Agriculture AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing... INSPECTION Regulations Definitions § 29.35 Lot seal. A seal approved by the Director for sealing lots of...

  7. Chemical analysis of DC745 Materials: DEV Lot 1 reinvestigation; barcodes P053387, P053388, and P053389

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Dirmyer, Matthew R.

    This report serves as a follow up to our initial development lot 1 chemical analysis report (LA-UR-16-21970). The purpose of that report was to determine whether or not certain combinations of resin lots and curing agent lots resulted in chemical differences in the final material. One finding of that report suggested that pad P053389 was different from the three other pads analyzed. This report consists of chemical analysis of P053387, P053388, and a reinvestigation of P053389 all of which came from the potentially suspect combination of resin and curing agents lot. The goal of this report is to determine whethermore » the observations relating to P053389 were isolated to that particular pad or systemic to that combination of resin and curing agent lot. The following suite of analyses were performed on the pads: Differential Scanning Calorimetry (DSC), Thermogravimetric Analysis (TGA), Fourier Transform Infrared Spectroscopy (FT-IR), and Solid State Nuclear Magnetic Resonance (NMR). The overall conclusions of the study are that pads P053387 and P053388 behave more consistently with the pads of other resin lot and curing agent lot combinations and that the chemical observations made regarding pad P053389 are isolated to that pad and not representative of an issue with that resin lot and curing agent lot combination.« less

  8. The Importance of Reagent Lot Registration in External Quality Assurance/Proficiency Testing Schemes.

    PubMed

    Stavelin, Anne; Riksheim, Berit Oddny; Christensen, Nina Gade; Sandberg, Sverre

    2016-05-01

    Providers of external quality assurance (EQA)/proficiency testing schemes have traditionally focused on evaluation of measurement procedures and participant performance and little attention has been given to reagent lot variation. The aim of the present study was to show the importance of reagent lot registration and evaluation in EQA schemes. Results from the Noklus (Norwegian Quality Improvement of Primary Care Laboratories) urine albumin/creatinine ratio (ACR) and prothrombin time international normalized ratio (INR) point-of-care EQA schemes from 2009-2015 were used as examples in this study. The between-participant CV for Afinion ACR increased from 6%-7% to 11% in 3 consecutive surveys. This increase was caused by differences between albumin reagent lots that were also observed when fresh urine samples were used. For the INR scheme, the CoaguChek INR results increased with the production date of the reagent lots, with reagent lot medians increasing from 2.0 to 2.5 INR and from 2.7 to 3.3 INR (from the oldest to the newest reagent lot) for 2 control levels, respectively. These differences in lot medians were not observed when native patient samples were used. Presenting results from different reagent lots in EQA feedback reports can give helpful information to the participants that may explain their deviant EQA results. Information regarding whether the reagent lot differences found in the schemes can affect patient samples is important and should be communicated to the participants as well as to the manufacturers. EQA providers should consider registering and evaluating results from reagent lots. © 2016 American Association for Clinical Chemistry.

  9. The establishment of tocopherol reference intervals for Hungarian adult population using a validated HPLC method.

    PubMed

    Veres, Gábor; Szpisjak, László; Bajtai, Attila; Siska, Andrea; Klivényi, Péter; Ilisz, István; Földesi, Imre; Vécsei, László; Zádori, Dénes

    2017-09-01

    Evidence suggests that decreased α-tocopherol (the most biologically active substance in the vitamin E group) level can cause neurological symptoms, most likely ataxia. The aim of the current study was to first provide reference intervals for serum tocopherols in the adult Hungarian population with appropriate sample size, recruiting healthy control subjects and neurological patients suffering from conditions without symptoms of ataxia, myopathy or cognitive deficiency. A validated HPLC method applying a diode array detector and rac-tocol as internal standard was utilized for that purpose. Furthermore, serum cholesterol levels were determined as well for data normalization. The calculated 2.5-97.5% reference intervals for α-, β/γ- and δ-tocopherols were 24.62-54.67, 0.81-3.69 and 0.29-1.07 μm, respectively, whereas the tocopherol/cholesterol ratios were 5.11-11.27, 0.14-0.72 and 0.06-0.22 μmol/mmol, respectively. The establishment of these reference intervals may improve the diagnostic accuracy of tocopherol measurements in certain neurological conditions with decreased tocopherol levels. Moreover, the current study draws special attention to the possible pitfalls in the complex process of the determination of reference intervals as well, including the selection of study population, the application of internal standard and method validation and the calculation of tocopherol/cholesterol ratios. Copyright © 2017 John Wiley & Sons, Ltd.

  10. Rapid and simple determination of selenium in blood serum by inductively coupled plasma-mass spectrometry (ICP-MS).

    PubMed

    Labat, L; Dehon, B; Lhermitte, M

    2003-05-01

    An inductively coupled plasma mass spectrometer (ICP-MS) with a rapid sample-preparative procedure was used for the determination of selenium in blood serum. Blood serum was prepared by dilution in an acidic solution consisting of nitric acid (1%), X-triton (0.1%) and 1-butanol (0.8%). A calibration curve was established for 1-40 microg mL(-1) (r(2)>0.99). The limit of detection was 0.5 microg mL(-1). Repeatability and intermediate precision were satisfactory with relative standard deviations (RSD) of 2.0% and 3.2%, respectively. This method was easily applied to reference materials with satisfactory accuracy. Good correlation (r(2)=0.96) was observed between ICP-MS and atomic absorption spectrometry (AAS) for the determination of (82)Se in blood serum from 23 patients. These results suggest that the sample preparative procedure coupled with ICP-MS can be used for the routine determination of (82)Se in human blood serum.

  11. Serum α1-proteinase inhibitor concentrations in dogs with exocrine pancreatic disease, chronic hepatitis or proteinuric chronic kidney disease.

    PubMed

    Heilmann, R M; Grützner, N; Hokamp, J A; Lidbury, J A; Xenoulis, P G; Suchodolski, J S; Nabity, M B; Cianciolo, R; Steiner, J M

    2018-06-01

    Serum canine α 1 -proteinase inhibitor (cα 1 -PI) concentrations were evaluated in dogs with pancreatitis (n=24), exocrine pancreatic insufficiency (EPI; n=29), chronic hepatitis (CH; n=11) or proteinuric chronic kidney disease (CKD-P; n=61) to determine whether systemic proteinase/proteinase-inhibitor balance is altered in these conditions. Dogs with CKD-P had significantly lower cα 1 -PI concentrations than dogs with pancreatitis, EPI or CH; 16% of dogs with CKD-P had serum cα 1 -PI concentrations below the reference interval. Serum and urine cα 1 -PI concentrations were inversely correlated in dogs with CKD-P, but not in dogs with CH. This suggests that renal loss of cα 1 -PI contributes to decreased serum concentrations in dogs with CKD-P, while hepatic cα 1 -PI synthesis with CH either is not compromised or is counterbalanced by extrahepatic production. Copyright © 2018 Elsevier Ltd. All rights reserved.

  12. 7 CFR 987.102 - Lot number.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Lot number. 987.102 Section 987.102 Agriculture... RIVERSIDE COUNTY, CALIFORNIA Administrative Rules Definitions § 987.102 Lot number. Lot number is synonymous with code and means a combination of letters or numbers, or both, acceptable to the Committee, showing...

  13. 7 CFR 987.102 - Lot number.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 8 2011-01-01 2011-01-01 false Lot number. 987.102 Section 987.102 Agriculture... RIVERSIDE COUNTY, CALIFORNIA Administrative Rules Definitions § 987.102 Lot number. Lot number is synonymous with code and means a combination of letters or numbers, or both, acceptable to the Committee, showing...

  14. 7 CFR 987.102 - Lot number.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 8 2013-01-01 2013-01-01 false Lot number. 987.102 Section 987.102 Agriculture... RIVERSIDE COUNTY, CALIFORNIA Administrative Rules Definitions § 987.102 Lot number. Lot number is synonymous with code and means a combination of letters or numbers, or both, acceptable to the Committee, showing...

  15. 7 CFR 987.102 - Lot number.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 8 2014-01-01 2014-01-01 false Lot number. 987.102 Section 987.102 Agriculture... RIVERSIDE COUNTY, CALIFORNIA Administrative Rules Definitions § 987.102 Lot number. Lot number is synonymous with code and means a combination of letters or numbers, or both, acceptable to the Committee, showing...

  16. 7 CFR 987.102 - Lot number.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 8 2012-01-01 2012-01-01 false Lot number. 987.102 Section 987.102 Agriculture... RIVERSIDE COUNTY, CALIFORNIA Administrative Rules Definitions § 987.102 Lot number. Lot number is synonymous with code and means a combination of letters or numbers, or both, acceptable to the Committee, showing...

  17. An organic transistor-based system for reference-less electrophysiological monitoring of excitable cells

    PubMed Central

    Spanu, A.; Lai, S.; Cosseddu, P.; Tedesco, M.; Martinoia, S.; Bonfiglio, A.

    2015-01-01

    In the last four decades, substantial advances have been done in the understanding of the electrical behavior of excitable cells. From the introduction in the early 70's of the Ion Sensitive Field Effect Transistor (ISFET), a lot of effort has been put in the development of more and more performing transistor-based devices to reliably interface electrogenic cells such as, for example, cardiac myocytes and neurons. However, depending on the type of application, the electronic devices used to this aim face several problems like the intrinsic rigidity of the materials (associated with foreign body rejection reactions), lack of transparency and the presence of a reference electrode. Here, an innovative system based on a novel kind of organic thin film transistor (OTFT), called organic charge modulated FET (OCMFET), is proposed as a flexible, transparent, reference-less transducer of the electrical activity of electrogenic cells. The exploitation of organic electronics in interfacing the living matters will open up new perspectives in the electrophysiological field allowing us to head toward a modern era of flexible, reference-less, and low cost probes with high-spatial and high-temporal resolution for a new generation of in-vitro and in-vivo monitoring platforms. PMID:25744085

  18. Improvement of an enzyme immunosorbent assay for detecting antibodies against Dioctophyma renale.

    PubMed

    Pedrassani, Daniela; do Nascimento, Adjair Antonio; André, Marcos Rogério; Machado, Rosangela Zacarias

    2015-09-15

    An available enzyme-linked immunosorbent assay (ELISA) was studied for the detection of anti-Dioctophyma renale antibodies in the sera of dogs using, detection of parasite eggs in urine sediment as a reference test. ELISA uses a soluble antigenic preparation of esophagus of D. renale and the optimal dilutions of the antigen, serum and conjugate were determined by means of checker board titration, using positive (n=13) and negative (n=27) reference serum. The specificity and sensitivity of the ELISA were 93.8% and 92.3% respectively and the kappa index was good (0.76). These results suggest that ELISA described may prove to be an effective serological test for detecting dogs infected and exposed to this parasite mainly dogs that are not eliminating parasite eggs through their urine. Copyright © 2015 Elsevier B.V. All rights reserved.

  19. Biological Variation and Reference Change Value Data for Serum Neuron-Specific Enolase in a Turkish Population.

    PubMed

    Matyar, Selcuk; Goruroglu Ozturk, Ozlem; Ziyanoglu Karacor, Esin; Yuzbasioglu Ariyurek, Sedefgul; Sahin, Gulhan; Kibar, Filiz; Yaman, Akgun; Inal, Tamer

    2016-11-01

    Neuron-specific enolase (NSE) is a recognized biomarker for the assessment of cerebral injury in neurological disorders. This study aims to report a definitive assessment of the biological variation (BV) components of this biomarker, including within-subject BV (CVI), between-subject BV (CVG), index of individuality (II), and reference change value (RCV), in a cohort of Turkish participants using an experimental protocol. Six blood specimens were collected from each of the 13 apparently healthy volunteers (seven women, six men; ranging in age from 23 to 36) on the same day, every 2 weeks for 2 months. Serum specimens were stored at -20°C until analysis. Neuron-specific enolase levels were evaluated in serum samples using an electrochemiluminescence (ECLIA) immunoassay kit with a Roche Cobas e 411 auto-analyser. ANOVA test was used to calculate the variations. The CVI and CVG for NSE were 21.5% and 28.8%, respectively. Analytical variation (CVA) was calculated as 10.2%. Additionally, II and RCV were calculated as 0.74 and 66% (95% confident interval, CI), respectively. As the performance index (PI) was found to be less than 2 (PI = 0.95), it is concluded that the NSE measurements have a desirable performance for analytical imprecision. Since the II was found to be less than 1 (II: 0.74), the reference values will be of little use. Thus, RCV would provide better information for deciding whether a significant change has occurred. © 2016 Wiley Periodicals, Inc.

  20. Age related prostate-specific antigen reference range among men in south-East Caspian Sea.

    PubMed

    Mansourian, A R; Ghaemi, E O; Ahmadi, A R; Marjani, A; Moradi, A; Saifi, A

    2007-05-01

    The purpose of this study was to describe the distribution of serum prostate specific antigen (PSA) and to determine age-specific reference range in a population of Persian men. Venous blood samples were taken from 287 men, from Gorgan located in the North of Iran, South-East of Caspian Sea, aged 15 > or = 80 year. The serum PSA levels was measured using Enzyme-linked Immunosorbant-Assay (ELISA) technique and age-specific range for PSA level was determined. The serum prostate-specific antigen level for six age group of 15-40 years, 41-50 years, 51-60 years, 61-70 years, 71-80 years and >80 years were mainly in the range of 0-2.5 ng mL(-1), for 76.6%, 2.6-4 ng mL(-1) for 9.1% and as whole 85.7% of all men in this study had < or = 4 ng mL(-1), 8.7 and 5.6% all men of six age group had PSA level of 4.1-10 ng mL(-1) and >10 ng mL(-1), respectively. The findings of present study indicated that a large proportion (76.6%) men in this region have a lower PSA level of 0-2.5 ng mL(-1) and only 9.1% of men have PSA level of 2.6-4 ng mL(-1). It is therefore concluded that acceptable reference range of 0-4 ng mL(-1) for PSA level require further reassessment.

  1. Comparison of particle sizes between 238PuO 2 before aqueous processing, after aqueous processing, and after ball milling

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Mulford, Roberta Nancy

    Particle sizes determined for a single lot of incoming Russian fuel and for a lot of fuel after aqueous processing are compared with particle sizes measured on fuel after ball-milling. The single samples of each type are believed to have particle size distributions typical of oxide from similar lots, as the processing of fuel lots is fairly uniform. Variation between lots is, as yet, uncharacterized. Sampling and particle size measurement methods are discussed elsewhere.

  2. Development of β-lactoglobulin-specific chimeric human IgEκ monoclonal antibodies for in vitro safety assessment of whey hydrolysates.

    PubMed

    Knipping, Karen; Simons, Peter J; Buelens-Sleumer, Laura S; Cox, Linda; den Hartog, Marcel; de Jong, Niels; Teshima, Reiko; Garssen, Johan; Boon, Louis; Knippels, Léon M J

    2014-01-01

    Cow's milk-derived whey hydrolysates are nutritional substitutes for allergic infants. Safety or residual allergenicity assessment of these whey hydrolysates is crucial. Currently, rat basophilic leukemia RBL-2H3 cells expressing the human IgE receptor α-chain (huFcεRIα-RBL-2H3), sensitized with serum IgE from cow's milk allergic children, are being employed to assess in vitro residual allergenicity of these whey hydrolysates. However, limited availability and inter-lot variation of these allergic sera impede standardization of whey hydrolysate safety testing in degranulation assays. An oligoclonal pool of chimeric human (chu)IgE antibodies against bovine β-lactoglobulin (a major allergen in whey) was generated to increase sensitivity, specificity, and reproducibility of existing degranulation assays. Mice were immunized with bovine β-lactoglobulin, and subsequently the variable domains of dissimilar anti-β-lactoglobulin mouse IgG antibodies were cloned and sequenced. Six chimeric antibodies were generated comprising mouse variable domains and human constant IgE/κ domains. After sensitization with this pool of anti-β-lactoglobulin chuIgEs, huFcεRIα-expressing RBL-2H3 cells demonstrated degranulation upon cross-linking with whey, native 18 kDa β-lactoglobulin, and 5-10 kDa whey hydrolysates, whereas a 3 kDa whey hydrolysate and cow's milk powder (mainly casein) showed no degranulation. In parallel, allergic serum IgEs were less sensitive. In addition, our pool anti-β-lactoglobulin chuIgEs recognized multiple allergenic immunodominant regions on β-lactoglobulin, which were also recognized by serum IgEs from cow's milk allergic children. Usage of our 'unlimited' source and well-defined pool of β-lactoglobulin-specific recombinant chuIgEs to sensitize huFcεRIα on RBL-2H3 cells showed to be a relevant and sensitive alternative for serum IgEs from cow's milk allergic patients to assess safety of whey-based non-allergic hydrolyzed formula.

  3. Type material of Platyhelminthes (Monogenoidea) housed in the Helminthological Collection of the Oswaldo Cruz Institute/ FIOCRUZ (CHIOC), Rio de Janeiro, Brazil, from 1979 to 2016.

    PubMed

    Lopes, Daniela A; Mainenti, Adriana; Sanches, Magda; Knoff, Marcelo; Gomes, Delir Corrêa

    2016-01-01

    A catalogue of type material of monogenoids deposited in the Helminthological Collection of the Oswaldo Cruz Institute, FIOCRUZ (CHIOC), between 1979 and 2016, is presented, given that the last list of types was produced in 1979. The monogenoid collection comprises type lots for 203 species, distributed across 14 families and 68 genera. Specific names are listed systematically, followed by type host, infection site, type locality, specimens with the collection numbers and references. The classification and the nomenclature of the species have been updated.

  4. [Development of an optimal scheme for calculating results of the use of an immunoenzyme test-system for determining the antigenic activity of a cultured antirabies vaccine].

    PubMed

    Tsetlin, E M; Volkova, R A

    1996-01-01

    Ninety-eight lots of commercial antirabies vaccine manufactured by Immunopreparat Research and Production Amalgamation have been tested using enzyme immunoassay system for the detection of rabies virus antigens. Comparison of different variants of interpreting and expressing the results helped define the optimal method for assessment of vaccine titer and reference values: optical density value equal to 0.2 is taken as the cut-off. Antigenic activity of the vaccine may be expressed in international units, similarly as immunogenic activity.

  5. Comparative Nozzle Study for Applying Aqueous Film Forming Foam on Large-Scale Fires

    DTIC Science & Technology

    1978-04-01

    MATERIALS The AFFF concentrate used in all the tests was FC-206, Lot 60, and met Military Specification, MIL - F - 24385 (Reference 7). JP-4 was used as...1974. 7. Military Speciiication, MlL- F - 24385 (Navy), November 21, 1969 and Amendment-8, June 20, 1974, "Fire Extinguishing Agent, Aqueous Film Forming...cx.itairnd ca air- ) ’O A7473 IEDITION OF I NOV 6% IS OBSOLETE D$/1 0102-LF 014-6601 UN ASI F ]LD SEQAIY LA$IFCAIO O THIS PAGE ’Who% lie(& Cd St CUP!TY

  6. Type material of Platyhelminthes (Monogenoidea) housed in the Helminthological Collection of the Oswaldo Cruz Institute/ FIOCRUZ (CHIOC), Rio de Janeiro, Brazil, from 1979 to 2016

    PubMed Central

    Lopes, Daniela A.; Mainenti, Adriana; Sanches, Magda; Knoff, Marcelo; Gomes, Delir Corrêa

    2016-01-01

    Abstract A catalogue of type material of monogenoids deposited in the Helminthological Collection of the Oswaldo Cruz Institute, FIOCRUZ (CHIOC), between 1979 and 2016, is presented, given that the last list of types was produced in 1979. The monogenoid collection comprises type lots for 203 species, distributed across 14 families and 68 genera. Specific names are listed systematically, followed by type host, infection site, type locality, specimens with the collection numbers and references. The classification and the nomenclature of the species have been updated. PMID:27667946

  7. Comparison of serum serotonin and serum 5-HIAA LC-MS/MS assays in the diagnosis of serotonin producing neuroendocrine neoplasms: A pilot study.

    PubMed

    Lindström, Mikael; Tohmola, Niina; Renkonen, Risto; Hämäläinen, Esa; Schalin-Jäntti, Camilla; Itkonen, Outi

    2018-07-01

    Serotonin (5-hydroxytyramine) is a mediator of gastrointestinal smooth muscle contraction, and is secreted by neuroendocrine neoplasms (NENs). We developed a liquid chromatography tandem mass spectrometry (LC-MS/MS) assay for serum serotonin to be used in NEN diagnostics and follow-up. We used serum samples from healthy volunteers (n = 31) and patients suspected or monitored for NEN (n = 98). Serotonin-D 4 internal standard was added to samples before solid phase extraction (SPE) and quantification by LC-MS/MS. The effects of sample handling and preparation on serotonin stability were studied. Finally, we established a provisional reference range for serum serotonin and compared our assay with serum 5-hydroxyindoleacetic acid (5-HIAA) for detection of NENs. Our assay is sensitive and has a wide linear range (10-10,000 nmol/l). Serum serotonin is stable for 7 days at room temperature and for 3 months at -20 °C. Sampling temperature is not critical. Normal range for serum serotonin was 270-1490 nmol/l. We found that serum serotonin and 5-HIAA performed equally well as diagnostic tests for NENs. Our LC-MS/MS assay for serum serotonin is well suited for clinical research and patient diagnostics. Our results confirm that it can complement 5-HIAA in diagnosis of NENs. Copyright © 2018 Elsevier B.V. All rights reserved.

  8. 7 CFR 932.151 - Incoming regulations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... inspection station other than the one where the lot was sampled. (b) Lot identification. Immediately upon... complete Form COC 3A or 3C, weight and grade report or such other lot identification form as may be... performance of all actions connected with the identification of lots of olives, the weighing of boxes or bins...

  9. 7 CFR 27.12 - Classification request for each lot of cotton.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 2 2014-01-01 2014-01-01 false Classification request for each lot of cotton. 27.12... CONTAINER REGULATIONS COTTON CLASSIFICATION UNDER COTTON FUTURES LEGISLATION Regulations Classification Requests § 27.12 Classification request for each lot of cotton. For each lot or mark of cotton of which the...

  10. 7 CFR 27.12 - Classification request for each lot of cotton.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 2 2010-01-01 2010-01-01 false Classification request for each lot of cotton. 27.12... CONTAINER REGULATIONS COTTON CLASSIFICATION UNDER COTTON FUTURES LEGISLATION Regulations Classification Requests § 27.12 Classification request for each lot of cotton. For each lot or mark of cotton of which the...

  11. 7 CFR 27.12 - Classification request for each lot of cotton.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 2 2013-01-01 2013-01-01 false Classification request for each lot of cotton. 27.12... CONTAINER REGULATIONS COTTON CLASSIFICATION UNDER COTTON FUTURES LEGISLATION Regulations Classification Requests § 27.12 Classification request for each lot of cotton. For each lot or mark of cotton of which the...

  12. 7 CFR 27.12 - Classification request for each lot of cotton.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 2 2011-01-01 2011-01-01 false Classification request for each lot of cotton. 27.12... CONTAINER REGULATIONS COTTON CLASSIFICATION UNDER COTTON FUTURES LEGISLATION Regulations Classification Requests § 27.12 Classification request for each lot of cotton. For each lot or mark of cotton of which the...

  13. 7 CFR 27.12 - Classification request for each lot of cotton.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 2 2012-01-01 2012-01-01 false Classification request for each lot of cotton. 27.12... CONTAINER REGULATIONS COTTON CLASSIFICATION UNDER COTTON FUTURES LEGISLATION Regulations Classification Requests § 27.12 Classification request for each lot of cotton. For each lot or mark of cotton of which the...

  14. 46 CFR 160.077-23 - Production tests and inspections.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... fixed anchor, or (C) a tensile test machine that is capable of holding a given tension. The assembly... testing of each incoming lot of inflation chamber material before using that lot in production; (iii) Have... inspector must perform or supervise testing and inspection of at least one PFD lot in each five lots...

  15. A Comparative Study on the Lot Release Systems for Vaccines as of 2016.

    PubMed

    Fujita, Kentaro; Naito, Seishiro; Ochiai, Masaki; Konda, Toshifumi; Kato, Atsushi

    2017-09-25

    Many countries have already established their own vaccine lot release system that is designed for each country's situation: while the World Health Organization promotes for the convergence of these regulatory systems so that vaccines of assured quality are provided globally. We conducted a questionnaire-based investigation of the lot release systems for vaccines in 7 countries and 2 regions. We found that a review of the summary protocol by the National Regulatory Authorities was commonly applied for the independent lot release of vaccines, however, we also noted some diversity between countries, especially in regard to the testing policy. Some countries and regions, including Japan, regularly tested every lot of vaccines, whereas the frequency of these tests was reduced in other countries and regions as determined based on the risk assessment of these products. Test items selected for the lot release varied among the countries or regions investigated, although there was a tendency to prioritize the potency tests. An understanding of the lot release policy may contribute to improving and harmonizing the lot release system globally in the future.

  16. Greening vacant lots to reduce violent crime: a randomised controlled trial

    PubMed Central

    Garvin, Eugenia C; Cannuscio, Carolyn C; Branas, Charles C

    2014-01-01

    Background Vacant lots are often overgrown with unwanted vegetation and filled with trash, making them attractive places to hide illegal guns, conduct illegal activities such as drug sales and prostitution, and engage in violent crime. There is some evidence that greening vacant lots is associated with reductions in violent crime. Methods We performed a randomised controlled trial of vacant lot greening to test the impact of this intervention on police reported crime and residents’ perceptions of safety and disorder. Greening consisted of cleaning the lots, planting grass and trees, and building a wooden fence around the perimeter. We randomly allocated two vacant lot clusters to the greening intervention or to the control status (no intervention). Administrative data were used to determine crime rates, and local resident interviews at baseline (n=29) and at follow-up (n=21) were used to assess perceptions of safety and disorder. Results Unadjusted difference-in-differences estimates showed a non-significant decrease in the number of total crimes and gun assaults around greened vacant lots compared with control. People around the intervention vacant lots reported feeling significantly safer after greening compared with those living around control vacant lots (p<0.01). Conclusions In this study, greening was associated with reductions in certain gun crimes and improvements in residents’ perceptions of safety. A larger randomised controlled trial is needed to further investigate the link between vacant lot greening and violence reduction. PMID:22871378

  17. Reference values of coplanar and non-coplanar PCBs in serum samples from two Italian population groups.

    PubMed

    Turci, Roberta; Finozzi, Enrico; Catenacci, Giovanni; Marinaccio, Alessandro; Balducci, Claudio; Minoia, Claudio

    2006-04-10

    The main goal of this study is to establish the reference values of individual Polychlorinated biphenyl (PCB) congeners in non-occupationally exposed subjects. Since the PCB pattern in human serum is related to the living area, two different population groups from North and Central Italy, were compared. Serum concentrations of both coplanar and non-coplanar PCB congeners were measured by using gas chromatography coupled with low-resolution mass spectrometry (HRGC-LRMS). A fast and reliable method for the determination of 60 congeners had been previously validated. Its reliability was further verified by using high-resolution mass spectrometry. Thirty-one congeners out of 60 were found at detectable concentrations in at least one sample. The mean value for total PCBs was found to be 2.48 and 3.93 microg/L for the two population groups. Eight dioxin-like PCBs were detected. In accordance with the findings from the literature, the most abundant congeners were found to be 153, 138, 180, and 170. Both univariate and multivariate analysis showed that age is a significant determinant of PCB concentrations. The correlation increased with increasing chlorination. Slight differences in the PCB pattern were observed in the two population groups.

  18. Milk and serum standard reference materials for monitoring organic contaminants in human samples.

    PubMed

    Schantz, Michele M; Eppe, Gauthier; Focant, Jean-François; Hamilton, Coreen; Heckert, N Alan; Heltsley, Rebecca M; Hoover, Dale; Keller, Jennifer M; Leigh, Stefan D; Patterson, Donald G; Pintar, Adam L; Sharpless, Katherine E; Sjödin, Andreas; Turner, Wayman E; Vander Pol, Stacy S; Wise, Stephen A

    2013-02-01

    Four new Standard Reference Materials (SRMs) have been developed to assist in the quality assurance of chemical contaminant measurements required for human biomonitoring studies, SRM 1953 Organic Contaminants in Non-Fortified Human Milk, SRM 1954 Organic Contaminants in Fortified Human Milk, SRM 1957 Organic Contaminants in Non-Fortified Human Serum, and SRM 1958 Organic Contaminants in Fortified Human Serum. These materials were developed as part of a collaboration between the National Institute of Standards and Technology (NIST) and the Centers for Disease Control and Prevention (CDC) with both agencies contributing data used in the certification of mass fraction values for a wide range of organic contaminants including polychlorinated biphenyl (PCB) congeners, chlorinated pesticides, polybrominated diphenyl ether (PBDE) congeners, and polychlorinated dibenzo-p-dioxin (PCDD) and dibenzofuran (PCDF) congeners. The certified mass fractions of the organic contaminants in unfortified samples, SRM 1953 and SRM 1957, ranged from 12 ng/kg to 2200 ng/kg with the exception of 4,4'-DDE in SRM 1953 at 7400 ng/kg with expanded uncertainties generally <14 %. This agreement suggests that there were no significant biases existing among the multiple methods used for analysis.

  19. Milk and serum standard reference materials for monitoring organic contaminants in human samples

    PubMed Central

    Eppe, Gauthier; Focant, Jean-François; Hamilton, Coreen; Heckert, N. Alan; Heltsley, Rebecca M.; Hoover, Dale; Keller, Jennifer M.; Leigh, Stefan D.; Patterson, Donald G.; Pintar, Adam L.; Sharpless, Katherine E.; Sjödin, Andreas; Turner, Wayman E.; Vander Pol, Stacy S.; Wise, Stephen A.

    2016-01-01

    Four new Standard Reference Materials (SRMs) have been developed to assist in the quality assurance of chemical contaminant measurements required for human biomonitoring studies, SRM 1953 Organic Contaminants in Non-Fortified Human Milk, SRM 1954 Organic Contaminants in Fortified Human Milk, SRM 1957 Organic Contaminants in Non-Fortified Human Serum, and SRM 1958 Organic Contaminants in Fortified Human Serum. These materials were developed as part of a collaboration between the National Institute of Standards and Technology (NIST) and the Centers for Disease Control and Prevention (CDC) with both agencies contributing data used in the certification of mass fraction values for a wide range of organic contaminants including polychlorinated biphenyl (PCB) congeners, chlorinated pesticides, polybrominated diphenyl ether (PBDE) congeners, and polychlorinated dibenzo-p-dioxin (PCDD) and dibenzofuran (PCDF) congeners. The certified mass fractions of the organic contaminants in unfortified samples, SRM 1953 and SRM 1957, ranged from 12 ng/kg to 2200 ng/kg with the exception of 4,4′-DDE in SRM 1953 at 7400 ng/kg with expanded uncertainties generally <14 %. This agreement suggests that there were no significant biases existing among the multiple methods used for analysis. PMID:23132544

  20. Psoroptes mites infestation in a captive Burmese Red Serow (Capricornis sumatraensis subspecies rubidus) of Indo-Burma bio-diversity hotspot.

    PubMed

    Shah, Nirali; Borpojari, Dhrubajyoti; Sarma, Kalyan; Ali, M Ayub; Saikia, Basanta; Bayan, Hitesh; Ahmed, Fazal Ali; Das, Gunjan

    2018-06-01

    An 8 years old male Burmese Red Serow ( Capricornis sumatraensis sub species rubidus ) from Aizawl Zoological Park was presented to the Teaching Veterinary Clinical Complex. An exploratory skin scraping revealed existence of nymphal as well as adult stages of mites of the Psoroptes spp. which were not associated with any overt lesions typical to mite infestation such as pruritus, erythema or scaling of the epidermis. The mites were identified as per their morphology, size and shape. Haemato-biochemical analysis revealed alteration of certain haematological and biochemical parameters. The red blood corpuscles were found to have anucleate cells with mild to absent central pallor. The absolute counts showed neutrophilic leucocytosis with mild monocytosis and lymphocytosis. Eosinophilic count was towards the higher side, indicating that the infestation was mild. The serum calcium, albumin, triglyceride, urea nitrogen (BUN) were found to be lower than normal, whereas serum ALT, AST, LDH, ALP and serum amylase were higher than the established reference indices. Due to lack of haemato-biochemical reference values specific to captive Serow, emphasis was given in this report to establish baseline data for this species.

  1. Evaluation of a tunable bandpass reaction cell for an inductively coupled plasma mass spectrometer for the determination of chromium and vanadium in serum and urine

    NASA Astrophysics Data System (ADS)

    Nixon, David E.; Neubauer, Kenneth R.; Eckdahl, Steven J.; Butz, John A.; Burritt, Mary F.

    2002-05-01

    A Dynamic Reaction Cell™ inductively coupled argon plasma mass spectrometer (DRC-ICP-MS) was evaluated for the determination of chromium and vanadium in serum and urine. Reaction cell conditions were evaluated for the elimination of ArC + and ClOH + interferences on chromium at mass 52 and OCl + on vanadium at mass 51. A diluent containing only 1% nitric acid and internal standards (Y and Ga) was used to prepare serum and urine for analysis. Instrument response calibration was achieved by using aqueous acidic standards spiked into pooled sera or urine matrices. The slopes of the calibration curves prepared in urine and serum matrices were nearly identical. On average, chromium detection limits are 2.5 times lower using the DRC than Zeeman graphite furnace atomic absorption spectrometry (ZGFAAS). Vanadium detection limits are approximately 50 times lower. Average detection limits achieved with DRC-ICP-MS are 0.075 μg Cr/l and 0.028 μg V/l. Average results for the analysis of National Institute of Standards and Technology Standard Reference Material (NIST SRM) 1598 Bovine Serum (attained over 22 days) are: 0.14 μg Cr/l and 0.068 μg V/l. The reference concentrations for vanadium and chromium in NIST SRM 1598 are (0.06) μg V/l and 0.14±0.08 μg Cr/l, respectively. Results for chromium and vanadium determinations on ICP-MS survey samples from the Toxocologie du Quebec are equivalent to those reported by high resolution inductively coupled plasma mass spectrometry (HR-ICP-MS) for the same survey samples.

  2. Depletion of serum carotenoid and other fat-soluble vitamin concentrations following obesity surgery.

    PubMed

    Granado-Lorencio, Fernando; Simal-Antón, Alberto; Blanco-Navarro, Inmaculada; González-Dominguez, Teresa; Pérez-Sacristán, Belén

    2011-10-01

    Obesity constitutes a growing health problem, and surgical treatment of severe obesity is increasingly used. Nutrient deficiencies are common following bariatric surgery and the evidence indicates a progressive increase in the incidence and severity of the deficiency of certain vitamins and related clinical conditions. Because of the potential role of carotenoids in disease prevention, our aim was to assess the carotenoid status in candidates for obesity surgery and the time-course changes following two bariatric procedures. Seventy-five candidates for bariatric surgery (17 men, 58 women; age 43 ± 10 years) and a total of 362 serum samples after obesity surgery (i.e., Roux-en-Y gastric bypass (n = 187) and biliopancreatic diversion (n = 175)) were consecutively collected and assessed. Retinol, α- and γ-tocopherol, 25-OH-vitamin D3, lutein, zeaxanthin, α- and β-cryptoxanthin, lycopene (trans and cis), α- and β-carotene (trans and cis) were analyzed by high-performance liquid chromatography. Mean serum levels of carotenoids in candidates for obesity surgery were within the reference values reported in controls and seasonal variations were present in several analytes. After surgery, and regardless of the type of intervention, all serum carotenoids dropped following first-order kinetics. Cis/trans ratio of lycopene and β-carotene did not change after surgery, over the time or between surgical procedures. On a long-term, serum carotenoids were at or below fifth percentile of reference groups. The chronic low levels of carotenoids in these patients compromise their availability to tissues, constituting an additional risk factor for other clinical conditions. Dietary advice on carotenoid-rich, fortified foods or supplements should be also evaluated in these patients.

  3. Prevalence of Parvovirus B19 and Parvovirus V9 DNA and Antibodies in Paired Bone Marrow and Serum Samples from Healthy Individuals

    PubMed Central

    Heegaard, Erik D.; Petersen, Bodil Laub; Heilmann, Carsten J.; Hornsleth, Allan

    2002-01-01

    Parvovirus B19 (hereafter referred to as B19) exhibits a marked tropism to human bone marrow (BM), and infection may lead to erythema infectiosum, arthropathy, hydrops fetalis, and various hematologic disorders. Recently, a distinct parvovirus isolate termed V9 with an unknown clinical spectrum was discovered. In contrast to the many studies of B19 serology and viremia, valid information on the frequency of B19 or V9 DNA in the BM of healthy individuals is limited. To develop a reference value, paired BM and serum samples from healthy subjects were tested for the presence of B19 and V9 DNA and specific antibodies. Immunoglobulin M (IgM) was not found in any of the serum samples. The prevalence of IgG showed a gradual and steady increase from 37% in children aged 1 to 5 years to 87% in people aged >50 years. When 190 well-characterized subjects were examined, B19 DNA was detected in the BM of 4 individuals (2.1%; 95% confidence interval, 0.58 to 5.3%) while none of the paired serum samples showed evidence of circulating viral DNA. V9 DNA was not found in any of the BM or serum samples. The finding of B19 DNA probably indicated a primary infection in one 7-year-old individual and reinfection or reactivation of persistent infection in the remaining three persons, aged 47 to 58 years. Serving as a benchmark for future studies, these findings are useful when interpreting epidemiologic data, performing BM transplantation, or considering clinical implications of parvovirus infection. PMID:11880419

  4. Prevalence of parvovirus B19 and parvovirus V9 DNA and antibodies in paired bone marrow and serum samples from healthy individuals.

    PubMed

    Heegaard, Erik D; Petersen, Bodil Laub; Heilmann, Carsten J; Hornsleth, Allan

    2002-03-01

    Parvovirus B19 (hereafter referred to as B19) exhibits a marked tropism to human bone marrow (BM), and infection may lead to erythema infectiosum, arthropathy, hydrops fetalis, and various hematologic disorders. Recently, a distinct parvovirus isolate termed V9 with an unknown clinical spectrum was discovered. In contrast to the many studies of B19 serology and viremia, valid information on the frequency of B19 or V9 DNA in the BM of healthy individuals is limited. To develop a reference value, paired BM and serum samples from healthy subjects were tested for the presence of B19 and V9 DNA and specific antibodies. Immunoglobulin M (IgM) was not found in any of the serum samples. The prevalence of IgG showed a gradual and steady increase from 37% in children aged 1 to 5 years to 87% in people aged >50 years. When 190 well-characterized subjects were examined, B19 DNA was detected in the BM of 4 individuals (2.1%; 95% confidence interval, 0.58 to 5.3%) while none of the paired serum samples showed evidence of circulating viral DNA. V9 DNA was not found in any of the BM or serum samples. The finding of B19 DNA probably indicated a primary infection in one 7-year-old individual and reinfection or reactivation of persistent infection in the remaining three persons, aged 47 to 58 years. Serving as a benchmark for future studies, these findings are useful when interpreting epidemiologic data, performing BM transplantation, or considering clinical implications of parvovirus infection.

  5. Cholesterol concentrations in lipoprotein fractions separated by anion-exchange-high-performance liquid chromatography in healthy dogs and dogs with hypercholesterolemia.

    PubMed

    Oda, Hitomi; Mori, Akihiro; Hirowatari, Yuji; Takoura, Toshie; Manita, Daisuke; Takahashi, Tomoya; Shono, Saori; Onozawa, Eri; Mizutani, Hisashi; Miki, Yohei; Itabashi, Yukiko; Sako, Toshinori

    2017-10-01

    Anion-exchange (AEX)-high-performance liquid chromatography (HPLC) for measurement of cholesterol can be used to separate serum lipoproteins (high-density lipoprotein (HDL); low-density lipoprotein (LDL); intermediate-density lipoprotein (IDL); very-low-density lipoprotein (VLDL)) in humans. However, AEX-HPLC has not been applied in veterinary practice. We had three objectives: (i) the validation of AEX-HPLC methods including the correlation of serum cholesterol concentration in lipoprotein fraction measured by AEX-HPLC and gel permeation-HPLC (GP-HPLC) in healthy dogs and those with hypercholesterolemia was investigated; (ii) the reference intervals of lipoprotein fractions measured by AEX-HPLC from healthy dogs (n=40) was established; (iii) lipoprotein fractions from the serum of healthy dogs (n=12) and dogs with hypercholesterolemia (n=23) were compared. Analytic reproducibility and precision of AEX-HPLC were acceptable. Positive correlation between serum concentrations of total cholesterol (Total-Chol), HDL cholesterol (HDL-Chol), LDL cholesterol (LDL-Chol)+IDL cholesterol (IDL-Chol), and VLDL cholesterol (VLDL-Chol) was noted for AEX-HPLC and GP-HPLC in healthy dogs and dogs with hypercholesterolemia. Reference intervals measured by AEX-HPLC for serum concentrations of Total-Chol, HDL-Chol, and LDL-Chol were determined to be 2.97-9.32, 2.79-6.57, 0.16-3.28mmol/L (2.5-97.5% interval), respectively. Furthermore, there was significant difference in lipoprotein profiles between healthy and dogs with hypercholesterolemia. These results suggest that AEX-HPLC can be used to evaluate lipoprotein profiles in dogs and could be a new useful indicator of hyperlipidemia in dogs. Copyright © 2017 Elsevier Ltd. All rights reserved.

  6. Body mass index in relation to serum prostate-specific antigen levels and prostate cancer risk.

    PubMed

    Bonn, Stephanie E; Sjölander, Arvid; Tillander, Annika; Wiklund, Fredrik; Grönberg, Henrik; Bälter, Katarina

    2016-07-01

    High Body mass index (BMI) has been directly associated with risk of aggressive or fatal prostate cancer. One possible explanation may be an effect of BMI on serum levels of prostate-specific antigen (PSA). To study the association between BMI and serum PSA as well as prostate cancer risk, a large cohort of men without prostate cancer at baseline was followed prospectively for prostate cancer diagnoses until 2015. Serum PSA and BMI were assessed among 15,827 men at baseline in 2010-2012. During follow-up, 735 men were diagnosed with prostate cancer with 282 (38.4%) classified as high-grade cancers. Multivariable linear regression models and natural cubic linear regression splines were fitted for analyses of BMI and log-PSA. For risk analysis, Cox proportional hazards regression models were used to estimate hazard ratios (HR) and 95% confidence intervals (CI) and natural cubic Cox regression splines producing standardized cancer-free probabilities were fitted. Results showed that baseline Serum PSA decreased by 1.6% (95% CI: -2.1 to -1.1) with every one unit increase in BMI. Statistically significant decreases of 3.7, 11.7 and 32.3% were seen for increasing BMI-categories of 25 < 30, 30 < 35 and ≥35 kg/m(2), respectively, compared to the reference (18.5 < 25 kg/m(2)). No statistically significant associations were seen between BMI and prostate cancer risk although results were indicative of a positive association to incidence rates of high-grade disease and an inverse association to incidence of low-grade disease. However, findings regarding risk are limited by the short follow-up time. In conclusion, BMI was inversely associated to PSA-levels. BMI should be taken into consideration when referring men to a prostate biopsy based on serum PSA-levels. © 2016 UICC.

  7. Prognostic Significance of Baseline Serum Sodium in Heart Failure With Preserved Ejection Fraction.

    PubMed

    Patel, Yash R; Kurgansky, Katherine E; Imran, Tasnim F; Orkaby, Ariela R; McLean, Robert R; Ho, Yuk-Lam; Cho, Kelly; Gaziano, J Michael; Djousse, Luc; Gagnon, David R; Joseph, Jacob

    2018-06-13

    The purpose of this study was to evaluate the relationship between serum sodium at the time of diagnosis and long term clinical outcomes in a large national cohort of patients with heart failure with preserved ejection fraction. We studied 25 440 patients with heart failure with preserved ejection fraction treated at Veterans Affairs medical centers across the United States between 2002 and 2012. Serum sodium at the time of heart failure diagnosis was analyzed as a continuous variable and in categories as follows: low (115.00-134.99 mmol/L), low-normal (135.00-137.99 mmol/L), referent group (138.00-140.99 mmol/L), high normal (141.00-143.99 mmol/L), and high (144.00-160.00 mmol/L). Multivariable Cox regression and negative binomial regression were performed to estimate hazard ratios (95% confidence interval [CI]) and incidence density ratios (95% CI) for the associations of serum sodium with mortality and hospitalizations (heart failure and all-cause), respectively. The average age of patients was 70.8 years, 96.2% were male, and 14% were black. Compared with the referent group, low, low-normal, and high sodium values were associated with 36% (95% CI, 28%-44%), 6% (95% CI, 1%-12%), and 9% (95% CI, 1%-17%) higher risk of all-cause mortality, respectively. Low and low-normal serum sodium were associated with 48% (95% CI, 10%-100%) and 38% (95% CI, 8%-77%) higher risk of number of days of heart failure hospitalizations per year, and with 44% (95% CI, 32%-56%) and 18% (95% CI, 10%-27%) higher risk of number of days of all-cause hospitalizations per year, respectively. Both elevated and reduced serum sodium, including values currently considered within normal range, are associated with adverse outcomes in patients with heart failure with preserved ejection fraction. © 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

  8. Certified reference material of volatile organic compounds for environmental analysis: BTEX in methanol.

    PubMed

    Neves, Laura A; Almeida, Renato R R; Rego, Eliane P; Rodrigues, Janaína Marques; de Carvalho, Lucas Junqueira; de M Goulart, Ana Letícia

    2015-04-01

    The Brazilian Metrology Institute (National Institute of Metrology, Quality, and Technology, Inmetro) has been developing a certified reference material (CRM) of the volatile organic compounds benzene; toluene; ethylbenzene; and ortho, meta, and para-xylenes (BTEX) in methanol, to ensure quality control for environmental-analysis measurements. The objective of this paper is to present the results of certification studies: uncertainty estimates related to characterization, a homogeneity study, and a stability study on a single lot of CRM composed of BTEX in methanol. The method used analysis of variance (ANOVA), a statistical tool, to evaluate the homogeneity and stability of the BTEX CRM, which complies with ISO Guide 30 series. The homogeneity and stability of the BTEX CRM was confirmed for all analytes and their respective properties. All the procedures used in this study complied with ISO GUIDE 34, ISO GUIDE 35, and the guide to the expression of uncertainty of measurement (GUM).

  9. Standardized methods and quality control limits for agar and broth microdilution susceptibility testing of Mycoplasma pneumoniae, Mycoplasma hominis, and Ureaplasma urealyticum.

    PubMed

    Waites, Ken B; Duffy, Lynn B; Bébéar, Cécile M; Matlow, Anne; Talkington, Deborah F; Kenny, George E; Totten, Patricia A; Bade, Donald J; Zheng, Xiaotian; Davidson, Maureen K; Shortridge, Virginia D; Watts, Jeffrey L; Brown, Steven D

    2012-11-01

    An international multilaboratory collaborative study was conducted to develop standard media and consensus methods for the performance and quality control of antimicrobial susceptibility testing of Mycoplasma pneumoniae, Mycoplasma hominis, and Ureaplasma urealyticum using broth microdilution and agar dilution techniques. A reference strain from the American Type Culture Collection was designated for each species, which was to be used for quality control purposes. Repeat testing of replicate samples of each reference strain by participating laboratories utilizing both methods and different lots of media enabled a 3- to 4-dilution MIC range to be established for drugs in several different classes, including tetracyclines, macrolides, ketolides, lincosamides, and fluoroquinolones. This represents the first multilaboratory collaboration to standardize susceptibility testing methods and to designate quality control parameters to ensure accurate and reliable assay results for mycoplasmas and ureaplasmas that infect humans.

  10. Liquid chromatographic determination of benzo(a)pyrene in total particulate matter of cigarette smoke

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Tomkins, B.A.; Jenkins, R.A.; Griest, W.H.

    The benzo(a)pyrene (BaP) delivery of reference and commercially available tobacco cigarettes, as well as reference and placebo marijuana cigarettes, is determined using a sequential liquid chromatographic/liquid chromatographic procedure. The total particulate matter of sample cigarette smoke is collected using a Cambridge filter pad, which is ultrasonically extracted with acetone. The resulting extract is filtered, then fractionated using semipreparative-scale normal phase liquid chromatography (LC). Quantitative determination is achieved using analytical-scale reverse phase LC equipped with a fluorescence detector. The method is precise (+/- 10-15% relative standard deviation) and yields 85% or better BaP recovery at the ng/cig. level. A single padmore » may be analyzed in 8 person-hours, while a more typical lot of 12 pads (6 pads each for 2 cigarette brands) may be analyzed in 10 person-days.« less

  11. 21 CFR 610.2 - Requests for samples and protocols; official release.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Biologics Evaluation and Research, a manufacturer shall not distribute a lot of a product until the lot is... Evaluation and Research, a manufacturer shall not distribute a lot of a biological product until the lot is... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Requests for samples and protocols; official...

  12. 21 CFR 610.2 - Requests for samples and protocols; official release.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Biologics Evaluation and Research, a manufacturer shall not distribute a lot of a product until the lot is... Evaluation and Research, a manufacturer shall not distribute a lot of a biological product until the lot is... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Requests for samples and protocols; official...

  13. Evaluation program for secondary spacecraft cells: Initial evaluation tests of General Electric Company 12.0 ampere-hour nickel-cadmium spacecraft cells for the international ultraviolet explorer

    NASA Technical Reports Server (NTRS)

    Harkness, J. D.

    1976-01-01

    An evaluation test program was conducted to insure that all cells put into the life cycle program are of high quality by the screening of cells found to have electrolyte leakage, internal shorts, low capacity, or inability of any cell to recover its open-circuit voltage above 1.150 volts during the internal short test. The 20 cells were manufactured for the National Aeronautics and Space Administration, Goddard Space Flight Center (GSFC). The cells are from a lot of 175 cells procured for the International Ultraviolet Explorer project. Due to a change in requirements, the project selected to use 6.0 ampere-hour cells. Therefore, the remaining cells of this lot have been placed in storage at GSFC for use on a future GSFC project. All the cells are rated at 12.0 ampere-hours and contain double ceramic seals. Test limits specify those values in which a cell is to be terminated from a particular charge or discharge. Requirements are referred to as normally expected values based on past performance of aerospace nickel cadmium cells with demonstrated life characteristics.

  14. Dynamic laser speckle applied to the analysis of maturation process of irradiated fresh fruits

    NASA Astrophysics Data System (ADS)

    Vincitorio, F. M.; Budini, N.; Freyre, C.; Mulone, C.; Fiorucci, M. P.; López, A. J.; Ramil, A.

    2012-10-01

    The treatment of fresh fruits with different doses of ionizing radiation has been found effective for delaying ripening and, in this way, to extend shelf life. This preservation method is likely to produce some functional or constitutive changes in the cellular structure of the fruit. In this work, a test of the effectiveness of fruit irradiation with relatively low doses was performed by using dynamic speckle imaging. Bananas from a same lot were chosen, being a first series of them irradiated with different doses of 0.2, 0.4 and 0.6 kGy (Gy = J/kg) and a second series with doses of 0.2, 0.4, 0.6 and 1 kGy. Non irradiated bananas (0 kGy) were considered as the lot reference for contrast. Irradiation was carried out at the Semi-Industrial Cobalt 60 facility of the Ezeiza Atomic Center, with an activity of 6 × 105 Curie and a dose rate of 28.5 Gy/min. The objective of this work is to analyze differences in the maturation process between irradiated and nonirradiated fruits by means of dynamic speckle pattern evaluation.

  15. Happy Back to the Future Day

    NASA Image and Video Library

    2015-09-23

    You might see a DeLorean zipping around Greenbelt, Maryland, on Oct. 21, 2015, the day Marty McFly and Doc Brown arrive from 1985 in "Back to the Future, Part II," but don't look for flaming tread marks in its wake. The DeLorean DMC-12, commonly seen on the roads of NASA’s Goddard Space Flight Center in Greenbelt, Maryland, is better known for the version that starred as a plutonium-powered time machine in the “Back to the Future” trilogy. After some investigation, Goddard’s Office of Communications found the owner of the stainless steel, gull-winged, two-door coupe. Goddard software test engineer, Brendan Rebo bought the 1982 DeLorean off eBay about four and a half years ago. “The car attracts a lot more attention than I expected,” Rebo admitted. “I hear a lot of jokes about whether or not I’ve reached 88 miles per hour yet.” As “Back to the Future” fans around the world celebrate today, Rebo also celebrates his birthday. While the second film predicted technology, such as flying cars, that doesn’t yet exist, people can still marvel at the classic car and movie reference. Credit: NASA/Goddard/Rebecca Roth

  16. Compatibility and infectivity of a Cercospora rodmanii formulation with enhancing agents. Final report

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Pennington, J.C.; Theriot, E.A.

    1983-06-01

    A formulation of the fungus Cercospora rodmanii Conway has been produced, as a biocontrol of waterhyacinth (Eichhornia crassipes (Mart.) Solms.). To ensure the most efficient germination of the formulation, 12 potential enhancing agents were tested for addition during the spray application. The agents were aspartic acid, glucose, glutamic acid, gum xanthan, nutrient agar, Ortho X-77 Spreader, Tween 20, Tween 60, Tween 80, sodium alginate, Super Slupper, and yeast extract. Compatibility of test agents and combinations of test agents with two lots of the formulation was determined in the laboratory. All combinations of test agents were compatible with both lots ofmore » the C. rodmanii formulation. The C. rodmanii formulation was sprayed with test agents on waterhyacinth pseudolaminae. Damage was monitored each week for 8 weeks by assigning a disease index to each original and new pseudolaminae. No spots having characteristics suggestive of C. rodmanii infection were observed at any time during the study. Lack of infectivity could be remedied by isolating a virulent strain of C. rodmanii from the field. Agents determined to be compatible in this study could then be reexamined for enhancing infectivity on a virulent C. rodmanii formulation. 14 references, 2 figures, 5 tables.« less

  17. Comparison of the availability of groundwater information sources in Poland with other European countries. Knowledge inventory for hydrogeology research - project KINDRA

    NASA Astrophysics Data System (ADS)

    Tomaszewska, Barbara; Dendys, Marta; Tyszer, Magdalena

    2017-11-01

    Regulations of the Water Framework Directive 200/60/EC (WFD) had been applied by European Union countries into their legislation system. However, it does not guarantee that the groundwater research has the same standard and quality in EU countries. KINDRA international research project was launched to assessment of existing groundwater-related practical and scientific knowledge based on a new Hydrogeological Research Classification System (HRC-SYS). This classification is supported by a web-service - the European Inventory of Groundwater Research (EIGR). The main goal of the project is implementation policy of optimization in groundwater research in EU. The preliminary result of survey about groundwater management shows that in Poland is a good state of implementation WFD. Good level of implementation is especially related with groundwater monitoring. It is because a lot of institutions and municipal entities carry out their tasks referring to quality or quantity assessment. Results of their works are published as reports, newsletters, maps, bulletins etc. These materials are potential source of information which can be a valuable contribution to EIGR. However, a lot of information are published only in polish language, so it is impossible to spread this knowledge in Europe.

  18. The effect of vegetarian diet on selected essential nutrients in children.

    PubMed

    Laskowska-Klita, Teresa; Chełchowska, Magdalena; Ambroszkiewicz, Jadwiga; Gajewska, Joanna; Klemarczyk, Witold

    2011-01-01

    Vegetarian diets are considered to promote health and reduce the risk of some chronic diseases. It is also known that restriction or exclusion of animal foods may result in low intake of essential nutrients. The aim of the presented study was to assess the intake and serum status of vitamin B12, folate, vitamins A, E and D, as well as concentrations of homocysteine, total antioxidant status and iron balance in Polish vegetarian children. The study included 50 children, aged 5-11 who had been referred to the Institute of Mother and Child for dietary consultation. From those, 32 were vegetarians (aged 6.5±4.2 years) and 18 omnivores (aged 7.9±2.7 years). Dietary constituents were analyzed using the nutritional programme Dietetyk2®. Folate and vitamin B12 were determined with a chemiluminescence immunoassay, total homocysteine with a fluorescence polarization immunoassay and TAS (total antioxidant status) by colorimetric method. Vitamin A and E in serum were determined by the high-pressure liquid chromatography method (HPLC) and vitamin D by immunoenzymatic assay (ELISA). Concentrations of iron, ferritin, transferrin and total iron-binding capacity (TIBC) in serum were determined by commercially available kits. In vegetarian children daily intake of vitamin B12 (1.6 ěg) was in the recommended range, that of folate (195 ěg) and vitamin A (1245 ěg) higher, but vitamin E slightly lower (6.6 ěg) and three-fold lower vitamin D (1.1 ěg) than references allowance. Serum concentrations of vitamin B12 (548 pg/ml), folate (12.8 ng/ml), vitamin A (1.2 ěmol/L), vitamin E (15.6 ěmol/l) were within physiological range, but that of vitamin D (13.7 ěg/L) was only half of the lowest limit of the reference value. In vegetarian children in comparison to omnivorous similar levels of homocysteine (6.13 ěmol/L vs 5.45 ěmol/L) and vitamin A (1,17 ěmol/L vs 1.32 ěmol/L) were observed. Lower (p<0.05) values of vitamin E (15.6 ěmol/L vs 18.4 ěmol/L) and TAS (1.21 mmol/L vs 1.30 mmol/L; p<0.0001) were found. Concentrations of iron markers were in physiological range. Obtained results indicated that intakes of vitamin B12 and folic acid from vegetarian diets are sufficient to maintain serum concentrations of both homocysteine and iron in the range observed in omnivorous children. High consumption of vitamin A and low vitamin E only slightly affected their serum values. Significantly lower concentration of serum vitamin E in vegetarian children in comparison to nonvegetarians may be reflected with statistically significant lowering of total antioxidant status. Insufficient intake of vitamin D and its low serum concentration should be under close monitoring in vegetarian children. In order to prevent vitamin D deficiency appropriate age-dependent supplementation should be considered.

  19. Rhabdomyolysis and coeliac disease: A causal or casual association? A case report and review of literature.

    PubMed

    Mandato, Claudia; Rossi, Alessandro; Caldore, Mariano; Lamba, Marta; Rocco, Michele; Auricchio, Renata; Vajro, Pietro; Siani, Paolo

    2018-02-01

    Rhabdomyolysis is a rare, potentially life-threatening condition, caused by multiple disorders. The association with Coeliac Disease (CD) has been rarely reported and in these cases muscular damage was imputed to hypokalemia. Herein we describe a new case of severe rhabdomyolysis in a child subsequently diagnosed as affected by CD, and review previous reports. A 3-year-old boy was referred for diarrhea, brown urine, muscular pain/weakness, and no history of muscular trauma. At entry, laboratory tests showed elevated levels of creatine kinase (CK) (x100 unv) and aspartate aminotransferase (AST) (x10 unv), alanine aminotrasferase (ALT) (x5 unv); electrolytes were within the reference range. Twenty-four hours after admission serum CK peaked 115,000 U/L and transaminases increased up to 30 times unv. Hyperhydration treatment was started with renal function monitoring. Urine output decreased little, while serum creatinine and urea nitrogen stayed within the reference range. Serum potassium levels went down to 2.8 mEq/L at day 3, in spite of supplementation. The patient completely recovered at day 16. Main metabolic causes of rhabdomyolysis were ruled out by appropriate tests. Because of rarely reported cases of CD/rhabdomyolysis, anti-tissue transglutaminase (tTG) antibodies were measured and found positive (IgA 34 U/mL, unv <9). HLA typing was DQA1 05:02, DQB1 03:02. As jejunal biopsy showed patchy villous atrophy, gluten free diet (GFD) was prescribed. One year after starting GFD, histology was normal. Literature (search engines: PUB MED and GOOGLE SCHOLAR) from 1980 to 2016 retrieved 8 cases (age range: 12 to 75 years old) previously described. The present case suggests to check for CD in children with severe rhabdomyolysis. Because severe rhabdomyolysis itself may elevate the serum potassium levels, hypokalemia might go unrecognized as the cause of muscular damage. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  20. CLSI-based transference and verification of CALIPER pediatric reference intervals for 29 Ortho VITROS 5600 chemistry assays.

    PubMed

    Higgins, Victoria; Truong, Dorothy; Woroch, Amy; Chan, Man Khun; Tahmasebi, Houman; Adeli, Khosrow

    2018-03-01

    Evidence-based reference intervals (RIs) are essential to accurately interpret pediatric laboratory test results. To fill gaps in pediatric RIs, the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) project developed an age- and sex-specific pediatric RI database based on healthy pediatric subjects. Originally established for Abbott ARCHITECT assays, CALIPER RIs were transferred to assays on Beckman, Roche, Siemens, and Ortho analytical platforms. This study provides transferred reference intervals for 29 biochemical assays for the Ortho VITROS 5600 Chemistry System (Ortho). Based on Clinical Laboratory Standards Institute (CLSI) guidelines, a method comparison analysis was performed by measuring approximately 200 patient serum samples using Abbott and Ortho assays. The equation of the line of best fit was calculated and the appropriateness of the linear model was assessed. This equation was used to transfer RIs from Abbott to Ortho assays. Transferred RIs were verified using 84 healthy pediatric serum samples from the CALIPER cohort. RIs for most chemistry analytes successfully transferred from Abbott to Ortho assays. Calcium and CO 2 did not meet statistical criteria for transference (r 2 <0.70). Of the 32 transferred reference intervals, 29 successfully verified with approximately 90% of results from reference samples falling within transferred confidence limits. Transferred RIs for total bilirubin, magnesium, and LDH did not meet verification criteria and are not reported. This study broadens the utility of the CALIPER pediatric RI database to laboratories using Ortho VITROS 5600 biochemical assays. Clinical laboratories should verify CALIPER reference intervals for their specific analytical platform and local population as recommended by CLSI. Copyright © 2018 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  1. Bone turnover marker reference intervals in young females.

    PubMed

    Callegari, Emma T; Gorelik, Alexandra; Garland, Suzanne M; Chiang, Cherie Y; Wark, John D

    2017-07-01

    Background The use of bone turnover markers in clinical practice and research in younger people is limited by the lack of normative data and understanding of common causes of variation in bone turnover marker values in this demographic. To appropriately interpret bone turnover markers, robust reference intervals specific to age, development and sex are necessary. This study aimed to determine reference intervals of bone turnover markers in females aged 16-25 years participating in the Safe-D study. Methods Participants were recruited through social networking site Facebook and were asked to complete an extensive, online questionnaire and attend a site visit. Participants were tested for serum carboxy-terminal cross-linking telopeptide of type 1 collagen and total procollagen type 1 N-propeptide using the Roche Elecsys automated analyser. Reference intervals were determined using the 2.5th to 97.5th percentiles of normalized bone turnover marker values. Results Of 406 participants, 149 were excluded due to medical conditions or medication use (except hormonal contraception) which may affect bone metabolism. In the remaining 257 participants, the reference interval was 230-1000 ng/L for serum carboxy-terminal cross-linking telopeptide of type 1 collagen and 27-131  µg/L for procollagen type 1 N-propeptide. Both marker concentrations were inversely correlated with age and oral contraceptive pill use. Therefore, intervals specific to these variables were calculated. Conclusions We defined robust reference intervals for cross-linking telopeptide of type 1 collagen and procollagen type 1 N-propeptide in young females grouped by age and contraceptive pill use. We examined bone turnover markers' relationship with several lifestyle, clinical and demographic factors. Our normative intervals should aid interpretation of bone turnover markers in young females particularly in those aged 16 to 19 years where reference intervals are currently provisional.

  2. Performance of Commercial Enzyme-Linked Immunosorbent Assays for Detection of Antibodies to Bordetella pertussis▿

    PubMed Central

    Riffelmann, M.; Thiel, K.; Schmetz, J.; Wirsing von Koenig, C. H.

    2010-01-01

    Measuring antibodies to Bordetella pertussis antigens is mostly done by enzyme-linked immunosorbent assays (ELISAs). We compared the performance of ELISA kits that were commercially available in Germany. Eleven measured IgG antibodies, and nine measured IgA antibodies. An in-house ELISA with purified antigens served as a reference method. Samples included two WHO reference preparations, the former Food and Drug Administration (FDA)/Center for Biologics Evaluation and Research (CBER) reference preparations, serum samples from patients with clinically suspected pertussis, and serum samples from patients having received a combined tetanus, diphtheria, and pertussis (Tdap) vaccination. Kits using pertussis toxin (PT) as an antigen showed linearity compared to the WHO Reference preparation (r2 between 0.82 and 0.99), and these kits could quantify antibodies according to the reference preparation. ELISA kits using mixed antigens showed no linear correlation to the reference preparations. Patient results were compared to results of in-house ELISAs using a dual cutoff of either ≥100 IU/ml anti-PT IgG or ≥40 IU/ml anti-PT IgG together with ≥12 IU/ml anti-PT IgA. The sensitivities of kits measuring IgG antibodies ranged between 0.84 and 1.00. The specificities of kits using PT as an antigen were between 0.81 and 0.93. The specificities of kits using mixed antigens were between 0.51 and 0.59 and were thus not acceptable. The sensitivities of kits measuring IgA antibodies ranged between 0.53 and 0.73, and the specificities were between 0.67 and 0.94, indicating that IgA antibodies may be of limited diagnostic value. Our data suggest that ELISAs should use purified PT as an antigen and be standardized to the 1st International Reference preparation. PMID:20943873

  3. Monitoring health interventions – who's afraid of LQAS?

    PubMed Central

    Pezzoli, Lorenzo; Kim, Sung Hye

    2013-01-01

    Lot quality assurance sampling (LQAS) is used to evaluate health services. Subunits of a population (lots) are accepted or rejected according to the number of failures in a random sample (N) of a given lot. If failures are greater than decision value (d), we reject the lot and recommend corrective actions in the lot (i.e. intervention area); if they are equal to or less than d, we accept it. We used LQAS to monitor coverage during the last 3 days of a meningitis vaccination campaign in Niger. We selected one health area (lot) per day reporting the lowest administrative coverage in the previous 2 days. In the sampling plan we considered: N to be small enough to allow us to evaluate one lot per day, deciding to sample 16 individuals from the selected villages of each health area, using probability proportionate to population size; thresholds and d to vary according to administrative coverage reported; α ≤5% (meaning that, if we would have conducted the survey 100 times, we would have accepted the lot up to five times when real coverage was at an unacceptable level) and β ≤20% (meaning that we would have rejected the lot up to 20 times, when real coverage was equal or above the satisfactory level). We classified all three lots as with the acceptable coverage. LQAS appeared to be a rapid, simple, and statistically sound method for in-process coverage assessment. We encourage colleagues in the field to consider using LQAS in complement with other monitoring techniques such as house-to-house monitoring. PMID:24206650

  4. Monitoring health interventions--who's afraid of LQAS?

    PubMed

    Pezzoli, Lorenzo; Kim, Sung Hye

    2013-11-08

    Lot quality assurance sampling (LQAS) is used to evaluate health services. Subunits of a population (lots) are accepted or rejected according to the number of failures in a random sample (N) of a given lot. If failures are greater than decision value (d), we reject the lot and recommend corrective actions in the lot (i.e. intervention area); if they are equal to or less than d, we accept it. We used LQAS to monitor coverage during the last 3 days of a meningitis vaccination campaign in Niger. We selected one health area (lot) per day reporting the lowest administrative coverage in the previous 2 days. In the sampling plan we considered: N to be small enough to allow us to evaluate one lot per day, deciding to sample 16 individuals from the selected villages of each health area, using probability proportionate to population size; thresholds and d to vary according to administrative coverage reported; α ≤5% (meaning that, if we would have conducted the survey 100 times, we would have accepted the lot up to five times when real coverage was at an unacceptable level) and β ≤20% (meaning that we would have rejected the lot up to 20 times, when real coverage was equal or above the satisfactory level). We classified all three lots as with the acceptable coverage. LQAS appeared to be a rapid, simple, and statistically sound method for in-process coverage assessment. We encourage colleagues in the field to consider using LQAS in complement with other monitoring techniques such as house-to-house monitoring.

  5. Thyroid axis dysfunction in patients with Prader-Willi syndrome during the first 2 years of life.

    PubMed

    Vaiani, Elisa; Herzovich, Viviana; Chaler, Eduardo; Chertkoff, Lilien; Rivarola, Marco A; Torrado, Maria; Belgorosky, Alicia

    2010-10-01

    Prader-Willi syndrome (PWS) is a genetic disorder caused by the loss of expression of paternally transcribed genes in a highly imprinted region of chromosome 15q11-13. The clinical phenotype has been well characterized, mostly related to hypothalamic dysfunction. Even though central hypothyroidism has been documented in 20-30% of patients with PWS, thyroid function during the first 2 years of life has not been clearly defined. To evaluate hypothalamic-pituitary-thyroid function in infant PWS patients. Eighteen patients with PWS, aged 0.16-2 years, were included in a prospective study. PWS diagnosis was based on clinical features and molecular analysis. Serum total (T) T4, free (F) T4, T3 and thyroid-stimulating hormone (TSH) were evaluated in the patients with PWS included in the study. Serum hormone values were compared to those of a large reference population of the same age. In 13 of 18 patients with PWS (72.2%), serum TT4 and/or FT4 levels were below the 2.5th percentile of the reference population, while in only one PWS patient serum T3 was below this cut-off. The results of this study suggest that transient or definitive thyrotropin-releasing hormone (TRH)-TSH thyroid axis dysfunction may frequently be present in infant PWS patients. Paediatricians should be aware of this dysfunction in this critical period of thyroid hormone action on neurological development. © 2010 Blackwell Publishing Ltd.

  6. Development of small scale cell culture models for screening poloxamer 188 lot-to-lot variation.

    PubMed

    Peng, Haofan; Hall, Kaitlyn M; Clayton, Blake; Wiltberger, Kelly; Hu, Weiwei; Hughes, Erik; Kane, John; Ney, Rachel; Ryll, Thomas

    2014-01-01

    Shear protectants such as poloxamer 188 play a critical role in protecting cells during cell culture bioprocessing. Lot-to-lot variation of poloxamer 188 was experienced during a routine technology transfer across sites of similar scale and equipment. Cell culture medium containing a specific poloxamer 188 lot resulted in an unusual drop in cell growth, viability, and titer during manufacturing runs. After switching poloxamer lots, culture performance returned to the expected level. In order to control the quality of poloxamer 188 and thus maintain better consistency in manufacturing, multiple small scale screening models were developed. Initially, a 5L bioreactor model was established to evaluate cell damage by high sparge rates with different poloxamer 188 lots. Subsequently, a more robust, simple, and efficient baffled shake flask model was developed. The baffled shake flask model can be performed in a high throughput manner to investigate the cell damage in a bubbling environment. The main cause of the poor performance was the loss of protection, rather than toxicity. It was also suggested that suspicious lots can be identified using different cell line and media. The screening methods provide easy, yet remarkable models for understanding and controlling cell damage due to raw material lot variation as well as studying the interaction between poloxamer 188 and cells. © 2014 American Institute of Chemical Engineers.

  7. Mentha spicata L. infusions as sources of antioxidant phenolic compounds: emerging reserve lots with special harvest requirements.

    PubMed

    Rita, Ingride; Pereira, Carla; Barros, Lillian; Santos-Buelga, Celestino; Ferreira, Isabel C F R

    2016-10-12

    Mentha spicata L., commonly known as spearmint, is widely used in both fresh and dry forms, for infusion preparation or in European and Indian cuisines. Recently, with the evolution of the tea market, several novel products with added value are emerging, and the standard lots have evolved to reserve lots, with special harvest requirements that confer them with enhanced organoleptic and sensorial characteristics. The apical leaves of these batches are collected in specific conditions having, then, a different chemical profile. In the present study, standard and reserve lots of M. spicata were assessed in terms of the antioxidants present in infusions prepared from the different lots. The reserve lots presented the highest concentration in all the compounds identified in relation to the standard lots, with 326 and 188 μg mL -1 of total phenolic compounds, respectively. Both types of samples presented rosmarinic acid as the most abundant phenolic compound, at concentrations of 169 and 101 μg mL -1 for reserve and standard lots, respectively. The antioxidant activity was higher in the reserve lots which had the highest total phenolic compounds content, with EC 50 values ranging from 152 to 336 μg mL -1 . The obtained results provide scientific information that may allow the consumer to make a conscientious choice.

  8. Comparing age-wise reference intervals for serum creatinine concentration in a "Reality check" of the recommended cut-off.

    PubMed

    Verma, Mascha; Khadapkar, Rashmi; Sahu, Priyadarshi Soumyaranjan; Das, Bibhu Ranjan

    2006-09-01

    An increase in the communication within the healthcare services, both nationally and internationally, has strengthened the need for harmonization of measurements and reference intervals in laboratory medicine. In the present report, the calculated reference interval for serum creatinine (sCr) levels of healthy normal individuals (n=1121) in different sex and age groups are compared with the established interval. The calculated reference interval for sCr level was 0.4-1.3 mg/dL and 0.6 to 1.3 mg/dL in the age groups of 21-40 and 41-60 years respectively. The difference between the mean sCr values in total males and total females (age range 21-60 years) was statistically significant (p<0.0001); When male and female subjects were analyzed age-group wise, the data showed a significant difference in mean sCr values (p<0.0001) in three age groups (21-30, 31-40 and 41-50 years) however, in older age group (51-60 years), the difference was non-significant (p=0.07). The reference ranges were 0.7-1.3 and 0.4-1.0 mg/dL for males and females respectively where the lower limit was 0.1-0.2 units less than that of standard limits. An increase in the mean value of sCr was observed particularly in females with an increase in age. Hence it is of interest to validate an age specific reference ranges for sCr in our population.

  9. 7 CFR 983.18 - Lot.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Orders; Fruits, Vegetables, Nuts), DEPARTMENT OF AGRICULTURE PISTACHIOS GROWN IN CALIFORNIA, ARIZONA, AND NEW MEXICO Definitions § 983.18 Lot. Lot means any quantity of pistachios that is submitted for...

  10. 75 FR 36673 - Notice of Inventory Completion: Public Museum of West Michigan, Grand Rapids, MI

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-28

    ... red ochre, 1 shell bracelet, 1 lot of bird bone, 1 flint flake, and 1 projectile point fragment. At an... 33 associated funerary objects are 1 Busycon shell dipper, 16 lots of bone awls and fragments, 1... lots of polished bone, 1 pottery vessel, and 1 lot of turtle carapace fragments. In 1879, human remains...

  11. 38 CFR 36.4255 - Loans for the acquisition of a lot.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2010-07-01 2010-07-01 false Loans for the acquisition of a lot. 36.4255 Section 36.4255 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS... of a lot. (a) A loan to finance all or part of the cost of acquisition by the veteran of a lot on...

  12. 38 CFR 36.4255 - Loans for the acquisition of a lot.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2013-07-01 2013-07-01 false Loans for the acquisition of a lot. 36.4255 Section 36.4255 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS... of a lot. (a) A loan to finance all or part of the cost of acquisition by the veteran of a lot on...

  13. 38 CFR 36.4255 - Loans for the acquisition of a lot.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2012-07-01 2012-07-01 false Loans for the acquisition of a lot. 36.4255 Section 36.4255 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS... of a lot. (a) A loan to finance all or part of the cost of acquisition by the veteran of a lot on...

  14. 38 CFR 36.4255 - Loans for the acquisition of a lot.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2011-07-01 2011-07-01 false Loans for the acquisition of a lot. 36.4255 Section 36.4255 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS... of a lot. (a) A loan to finance all or part of the cost of acquisition by the veteran of a lot on...

  15. 38 CFR 36.4255 - Loans for the acquisition of a lot.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2014-07-01 2014-07-01 false Loans for the acquisition of a lot. 36.4255 Section 36.4255 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS... of a lot. (a) A loan to finance all or part of the cost of acquisition by the veteran of a lot on...

  16. Blood Phosphorus and Magnesium Levels in 130 Elite Track and Field Athletes

    PubMed Central

    Malliaropoulos, Nikolaos; Tsitas, Kostas; Porfiriadou, Anthoula; Papalada, Agapi; R.Ames, Paul; Del Buono, Angelo; Lippi, Giuseppe; Maffulli, Nicola

    2012-01-01

    Purpose This study tested the clinical utility and relevance of serum phosphorus and magnesium as markers possibly useful to monitor training in athletes. Methods Phosphorus and magnesium serum concentrations of 130 elite track and field athletes (65 males and 65 females, age range 20-30 years) from the National Athletics Sports Medicine Center database in Thessaloniki, Greece were measured. Results Abnormal results were found in 61 (47%) athletes (32 men and 29 women). In male athletes, serum phosphate was higher than normal in 18% and decreased in 1.5%, whereas serum magnesium concentration was higher in 26%, and lower in 3%. Regarding female athletes, higher serum phosphate and magnesium levels were detected in 26% and 17% respectively, whereas decreased serum magnesium was found in 3%. The most common alterations were higher serum phosphate (29/61, 47%) and magnesium concentrations (28/61, 46%). Abnormalities of serum phosphorus and magnesium concentrations were detected in almost half of the athletes. Hyperphosphataemia and hypermagnesaemia were the most common abnormalities. Conclusion The reference intervals used for general population cannot be used for athletes. Given the lack of pathological manifestations, the physiopathological significance of these findings is uncertain. Further studies on the interpretation of reported ion concentrations in athletes should take in account the type of sport practiced and also the possible variations during the training and competition season. PMID:23785576

  17. [Association between serum zinc level and hypercholesterolemia and insulin resistance in Brazilian children].

    PubMed

    Albuquerque, Fernanda Martins de; Filgueiras, Mariana De Santis; Rocha, Naruna Pereira; Castro, Ana Paula Pereira; Milagres, Luana Cupertino; Pessoa, Milene Cristine; Fransceschini, Sylvia do Carmo Castro; Novaes, Juliana Farias de

    2018-02-05

    The objective of the study was to assess the association between serum zinc level and cardiometabolic factors in prepubertal Brazilian children. This was a cross-sectional study in a representative sample of schoolchildren 8 to 9 years of age in public and private urban schools in Viçosa, Minas Gerais State, Brazil. Body composition was assessed with dual-energy x-ray absorptiometry. The study measured serum glucose, insulin, total cholesterol, high and low density lipoprotein cholesterol, triglycerides, apolipoproteins A (Apo A) and B, uric acid, leptin, homocysteine, ultrasenstive C-reactive protein, and serum zinc. Arterial pressure was measured with automatic inflation equipment. Zinc deficiency was observed in 1.3% of the children. Girls showed the worst cardiometabolic profile, with higher prevalence of increased android fat, triglycerides, insulin resistance, leptin, zinc, and Apo A. In the first tertile of serum zinc concentration, prevalence of insulin resistance was 96% higher (PR = 1.96; 95%CI: 1.04-3.66) and hypercholesterolemia was 23% lower (PR = 0.77; 95%CI: 0.61-0.96) than in the reference category (grouped 2nd and 3rd tertiles of serum zinc concentration). Despite the low prevalence of zinc deficiency, insulin resistance was more prevalent in children in the lowest third of serum zinc concentration. It is important to prevent cardiometabolic alterations in childhood, especially insulin resistance, with an emphasis on serum zinc level.

  18. Application of overlay modeling and control with Zernike polynomials in an HVM environment

    NASA Astrophysics Data System (ADS)

    Ju, JaeWuk; Kim, MinGyu; Lee, JuHan; Nabeth, Jeremy; Jeon, Sanghuck; Heo, Hoyoung; Robinson, John C.; Pierson, Bill

    2016-03-01

    Shrinking technology nodes and smaller process margins require improved photolithography overlay control. Generally, overlay measurement results are modeled with Cartesian polynomial functions for both intra-field and inter-field models and the model coefficients are sent to an advanced process control (APC) system operating in an XY Cartesian basis. Dampened overlay corrections, typically via exponentially or linearly weighted moving average in time, are then retrieved from the APC system to apply on the scanner in XY Cartesian form for subsequent lot exposure. The goal of the above method is to process lots with corrections that target the least possible overlay misregistration in steady state as well as in change point situations. In this study, we model overlay errors on product using Zernike polynomials with same fitting capability as the process of reference (POR) to represent the wafer-level terms, and use the standard Cartesian polynomials to represent the field-level terms. APC calculations for wafer-level correction are performed in Zernike basis while field-level calculations use standard XY Cartesian basis. Finally, weighted wafer-level correction terms are converted to XY Cartesian space in order to be applied on the scanner, along with field-level corrections, for future wafer exposures. Since Zernike polynomials have the property of being orthogonal in the unit disk we are able to reduce the amount of collinearity between terms and improve overlay stability. Our real time Zernike modeling and feedback evaluation was performed on a 20-lot dataset in a high volume manufacturing (HVM) environment. The measured on-product results were compared to POR and showed a 7% reduction in overlay variation including a 22% terms variation. This led to an on-product raw overlay Mean + 3Sigma X&Y improvement of 5% and resulted in 0.1% yield improvement.

  19. Screening for cystic fibrosis in New York State: considerations for algorithm improvements.

    PubMed

    Kay, Denise M; Maloney, Breanne; Hamel, Rhonda; Pearce, Melissa; DeMartino, Lenore; McMahon, Rebecca; McGrath, Emily; Krein, Lea; Vogel, Beth; Saavedra-Matiz, Carlos A; Caggana, Michele; Tavakoli, Norma P

    2016-02-01

    Newborn screening for cystic fibrosis (CF), a chronic progressive disease affecting mucus viscosity, has been beneficial in both improving life expectancy and the quality of life for individuals with CF. In New York State from 2007 to 2012 screening for CF involved measuring immunoreactive trypsinogen (IRT) levels in dried blood spots from newborns using the IMMUCHEM(™) Blood Spot Trypsin-MW ELISA kit. Any specimen in the top 5% IRT level underwent DNA analysis using the InPlex(®) CF Molecular Test. Of the 1.48 million newborns screened during the 6-year time period, 7631 babies were referred for follow-up. CF was confirmed in 251 cases, and 94 cases were diagnosed with CF transmembrane conductance regulated-related metabolic syndrome or possible CF. Nine reports of false negatives were made to the program. Variation in daily average IRT was observed depending on the season (4-6 ng/ml) and kit lot (<3 ng/ml), supporting the use of a floating cutoff. The screening method had a sensitivity of 96.5%, specificity of 99.6%, positive predictive value of 4.5%, and negative predictive value of 99.5%. Considerations for CF screening algorithms should include IRT variations resulting from age at specimen collection, sex, race/ethnicity, season, and manufacturer kit lots. Measuring IRT level in dried blood spots is the first-tier screen for CF. Current algorithms for CF screening lead to substantial false-positive referral rates. IRT values were affected by age of infant when specimen is collected, race/ethnicity and sex of infant, and changes in seasons and manufacturer kit lots The prevalence of CF in NYS is 1 in 4200 with the highest prevalence in White infants (1 in 2600) and the lowest in Black infants (1 in 15,400).

  20. Roche/BIOTECON Diagnostics LightCycler foodproof L. monocytogenes detection kit in combination with ShortPrep foodproof II Kit. Performance-Tested Method 070401.

    PubMed

    Junge, Benjamin; Berghof-Jäger, Kornelia

    2006-01-01

    A method was developed for the detection of L. monocytogenes in food based on real-time polymerase chain reaction (PCR). This advanced PCR method was designed to reduce the time needed to achieve results from PCR reactions and to enable the user to monitor the amplification of the PCR product simultaneously, in real-time. After DNA isolation using the Roche/BIOTECON Diagnostics ShortPrep foodproof II Kit (formerly called Listeria ShortPrep Kit) designed for the rapid preparation of L. monocytogenes DNA for direct use in PCR, the real-time detection of L. monocytogenes DNA is performed by using the Roche/BIOTECON Diagnostics LightCycler foodproof L. monocytogenes Detection Kit. This kit provides primers and hybridization probes for sequence-specific detection, convenient premixed reagents, and different controls for reliable interpretation of results. For repeatability studies, 20 different foods, covering the 15 food groups recommended from the AOAC Research Institute (AOAC RI) for L. monocytogenes detection were analyzed: raw meats, fresh produce/vegetables, processed meats, seafood, egg and egg products, dairy (cultured/noncultured), spices, dry foods, fruit/juices, uncooked pasta, nuts, confectionery, pet food, food dyes and colorings, and miscellaneous. From each food 20, samples were inoculated with a low level (1-10 colony-forming units (CFU)/25 g) and 20 samples with a high level (10-50 CFU/25 g) of L. monocytogenes. Additionally, 5 uninoculated samples were prepared from each food. The food samples were examined with the test kits and in correlation with the cultural methods according to U.S. Food and Drug Administration (FDA) Bacteriological Analytical Manual (BAM) or U.S. Department of Agriculture (USDA)/Food Safety and Inspection Service (FSIS) Microbiology Laboratory Guidebook. After 48 h of incubation, the PCR method in all cases showed equal or better results than the reference cultural FDA/BAM or USDA/FSIS methods. Fifteen out of 20 tested food types gave exactly the same amount of positive samples for both methods in both inoculation levels. For 5 out of 20 foodstuffs, the PCR method resulted in more positives than the reference method after 48 h of incubation. Following AOAC RI definition, these were false positives because they were not confirmed by the reference method (false-positive rate for low inoculated foodstuffs: 5.4%; for high inoculated foodstuffs: 7.1%). Without calculating these unconfirmed positives, the PCR method showed equal sensitivity results compared to the alternative method. With the unconfirmed PCR-positives included into the calculations, the alternative PCR method showed a higher sensitivity than the microbiological methods (low inoculation level: 100 vs 98.0%; sensitivity rate: 1; high inoculation level: 99.7 vs 97.7%; sensitivity rate, 1). All in-house and independently tested uninoculated food samples were negative for L. monocytogenes. The ruggedness testing of both ShortPrep foodproof II Kit and Roche/BIOTECON LightCycler foodproof L. monocytogenes Detection Kit showed no noteworthy influences to any variation of the parameters component concentration, apparatus comparison, tester comparison, and sample volumes. In total, 102 L. monocytogenes isolates (cultures and pure DNA) were tested and detected for the inclusivity study, including all isolates claimed by the AOAC RI. The exclusivity study included 60 non-L. monocytogenes bacteria. None of the tested isolates gave a false-positive result; specificity was 100%. Three different lots were tested in the lot-to-lot study. All 3 lots gave equal results. The stability study was subdivided into 3 parts: long-term study, stress test, and freeze-defrost test. Three lots were tested in 4 time intervals within a period of 13 months. They all gave comparable results for all test intervals. For the stress test, LightCycler L. monocytogenes detection mixes were stored at different temperatures and tested at different time points during 1 month. Stable results were produced at all storage temperatures. The freeze-defrost analysis showed no noteworthy aggravation of test results. The independent validation study examined by Campden and Chorleywood Food Research Association Group (CCFRA) demonstrated again that the LightCycler L. monocytogenes detection system shows a comparable sensitivity to reference methods. With both the LightCycler PCR and BAM methods, 19 out of 20 inoculated food samples were detected. The 24 h PCR results generated by the LightCycler system corresponded directly with the FDA/BAM culture results. However, the 48 h PCR results did not relate exactly to the FDA/BAM results, as one sample found to be positive by the 48 h PCR could not be culturally confirmed and another sample which was negative by the 48 h PCR was culturally positive.

  1. [Preparation and characterization of follwing the national standard anti-Brucella abortus serum, bovine].

    PubMed

    Li, Cui; Guan, Fushi; Dai, Zhihong; Jiang, Hui; Wen, Fang; Lu, Lianshou; Wang, Zaishi

    2011-05-01

    To prepare anti-Brucella abortus serum used for calibrate the agglutination test follwing the national standard, 4 anti-Brucella abortus sera were obtained from 4 cows infected with Brucella abortus naturally. By potency testing, the third serum was selected. Sterility, vaccum degree, residual moisture, uniformity and stability of this standard material were tested and proved to meet the national standard. Referring to the international standard, RBT (Rose-Bengal plate agglutination test), SAT (standard tube agglutination) and CFT (complement fixation test) titers of this standard material were measured to be 1:160 "+" 1:2 400 "++" and 1:800 "++", which are identical with the collaborative assay results. International unit of the standard material is 4 000 IU/mL.

  2. Simultaneous determination of glucose, triglycerides, urea, cholesterol, albumin and total protein in human plasma by Fourier transform infrared spectroscopy: direct clinical biochemistry without reagents.

    PubMed

    Jessen, Torben E; Höskuldsson, Agnar T; Bjerrum, Poul J; Verder, Henrik; Sørensen, Lars; Bratholm, Palle S; Christensen, Bo; Jensen, Lene S; Jensen, Maria A B

    2014-09-01

    Direct measurement of chemical constituents in complex biologic matrices without the use of analyte specific reagents could be a step forward toward the simplification of clinical biochemistry. Problems related to reagents such as production errors, improper handling, and lot-to-lot variations would be eliminated as well as errors occurring during assay execution. We describe and validate a reagent free method for direct measurement of six analytes in human plasma based on Fourier-transform infrared spectroscopy (FTIR). Blood plasma is analyzed without any sample preparation. FTIR spectrum of the raw plasma is recorded in a sampling cuvette specially designed for measurement of aqueous solutions. For each analyte, a mathematical calibration process is performed by a stepwise selection of wavelengths giving the optimal least-squares correlation between the measured FTIR signal and the analyte concentration measured by conventional clinical reference methods. The developed calibration algorithms are subsequently evaluated for their capability to predict the concentration of the six analytes in blinded patient samples. The correlation between the six FTIR methods and corresponding reference methods were 0.87

  3. Accuracy and User Performance Evaluation of a New, Wireless-enabled Blood Glucose Monitoring System That Links to a Smart Mobile Device.

    PubMed

    Bailey, Timothy S; Wallace, Jane F; Pardo, Scott; Warchal-Windham, Mary Ellen; Harrison, Bern; Morin, Robert; Christiansen, Mark

    2017-07-01

    The new Contour ® Plus ONE blood glucose monitoring system (BGMS) features an easy-to-use, wireless-enabled blood glucose meter that links to a smart mobile device via Bluetooth ® connectivity and can sync with the Contour ™ Diabetes app on a smartphone or tablet. The accuracy of the new BGMS was assessed in 2 studies according to ISO 15197:2013 criteria. In Study 1 (laboratory study), fingertip capillary blood samples from 100 subjects were tested in duplicate using 3 test strip lots. In Study 2 (clinical study), 134 subjects with type 1 or type 2 diabetes enrolled at 2 clinical sites. BGMS results and YSI analyzer (YSI) reference results were compared for fingertip blood obtained by untrained subjects' self-testing and for study staff-obtained fingertip, subject palm, and venous results. In Study 1, 99.0% (594/600) of combined results for all 3 test strip lots fulfilled ISO 15197:2013 Section 6.3 accuracy criteria. In Study 2, 99.2% (133/134) of subject-obtained capillary fingertip results, 99.2% (133/134) of study staff-obtained fingertip results, 99.2% (125/126) of subject-obtained palm results, and 100% (132/132) of study staff-obtained venous results met ISO 15197:2013 Section 8 accuracy criteria. Moreover, 95.5% (128/134) of subject-obtained fingertip self-test results were within ±10 mg/dl (±0.6 mmol/L) or ±10% of the YSI reference result. Questionnaire results showed that most subjects found the BGMS easy to use. The BGMS exceeded ISO 15197:2013 accuracy criteria both in the laboratory and in a clinical setting when used by untrained subjects with diabetes.

  4. Serum Trans Fatty Acids Are Not Associated with Weight Gain or Linear Growth in School-Age Children123

    PubMed Central

    Baylin, Ana; Perng, Wei; Mora-Plazas, Mercedes; Marin, Constanza; Villamor, Eduardo

    2015-01-01

    Background: Animal and human adult studies indicate that long-term intake of trans fatty acids (TFAs) may be associated with weight gain. High intake of fast foods and snacks, which are rich in TFAs, is linked to overweight status among school-age children. However, the specific effects of TFAs in this population are unknown. Objective: We examined whether serum TFAs, used as biomarkers of intake, are associated with faster weight gain and linear growth during school years. Methods: We quantified TFAs by GLC in serum samples of 668 children aged 5–12 y at the time of recruitment into an ongoing cohort study performed in Bogota (Colombia) since 2006. Serum proportions of trans palmitoleic acid (16:1t), trans oleic acid (18:1t), trans linoleic acid (18:2t), and total TFAs were used as biomarkers of intake. Anthropometric characteristics were measured periodically for a median of 30 mo. Body mass index-for-age z scores (BAZs) and height-for-age z scores (HAZs) were calculated with the use of the WHO reference. We estimated mean changes in BAZs and HAZs over follow-up according to quartiles of each TFA at baseline by using mixed-effects regression models with restricted cubic splines. Results: Proportions of trans palmitoleic acid, trans oleic acid, trans linoleic acid, and total TFAs (mean ± SD, % of total serum FAs), were 0.22 ± 0.06, 0.91 ± 0.37, 0.96 ± 0.27, and 2.10 ± 0.59, respectively. Serum TFAs were not associated with changes in BAZs and HAZs after adjusting for sex, baseline age, and socioeconomic status. In a subgroup analysis by sex, serum trans palmitoleic acid was positively associated with the estimated change in HAZs from ages 6 to 14 y in boys (with use of the first quartile as the reference, differences in HAZs for trans palmitoleic acid quartiles were 0.73, 0.53, and 0.70, P-trend = 0.03). Conclusions: Proportions of serum TFAs, used as biomarkers of TFA intake, were not associated with weight gain in children aged 6–14 y in low- and middle-income populations in Bogota. The proportion of trans palmitoleic acid was positively associated with linear growth in boys. Longer follow-up and studies in diverse cohorts with wider ranges of TFA intake are warranted. PMID:26180252

  5. Standard Specimen Reference Set: Colon — EDRN Public Portal

    Cancer.gov

    The Early Detection Research Network, Great Lakes-New England Clinical, Epidemiological and Validation Center (GLNE CVC) announces the availability of serum, plasma and urine samples for the early detection for colon cancer and validation studies.

  6. [Addison disease during pregnancy--a diagnostic dilemma. Symptoms are similar to normal pregnancy problems].

    PubMed

    Wålinder, Olov

    The symptoms of primary adrenocortical insufficiency (Addison's disease) such as fatigue, anorexia, hypotension and hyperpigmentation are similar to those of normal pregnancy. Addison's disease is rare and the diagnosis can easily be overlooked during pregnancy. The concentration of corticosteroid-binding globulin (CBG) and cortisol in serum as well as urinary free cortisol increase 2-3 times during pregnancy. Therefore, the reference ranges for nonpregnant persons cannot be used during pregnancy. The diagnosis of Addison's disease in pregnancy should be based on analysis of p-ACTH which remains within the reference range in normal pregnancy until delivery. A case of Addison's disease diagnosed during pregnancy is presented and it illustrates the diagnostic difficulties. In patients taking oral estrogen containing contraceptives, serum levels of CBG and cortisol also increase 2-3 times, making s-cortisol values difficult to interpret. Also in these patients, analysis of p-ACTH is of value when suspecting Addison's disease.

  7. Large-scale identification of core-fucosylated glycopeptide sites in pancreatic cancer serum using mass spectrometry.

    PubMed

    Tan, Zhijing; Yin, Haidi; Nie, Song; Lin, Zhenxin; Zhu, Jianhui; Ruffin, Mack T; Anderson, Michelle A; Simeone, Diane M; Lubman, David M

    2015-04-03

    Glycosylation has significant effects on protein function and cell metastasis, which are important in cancer progression. It is of great interest to identify site-specific glycosylation in search of potential cancer biomarkers. However, the abundance of glycopeptides is low compared to that of nonglycopeptides after trypsin digestion of serum samples, and the mass spectrometric signals of glycopeptides are often masked by coeluting nonglycopeptides due to low ionization efficiency. Selective enrichment of glycopeptides from complex serum samples is essential for mass spectrometry (MS)-based analysis. Herein, a strategy has been optimized using LCA enrichment to improve the identification of core-fucosylation (CF) sites in serum of pancreatic cancer patients. The optimized strategy was then applied to analyze CF glycopeptide sites in 13 sets of serum samples from pancreatic cancer, chronic pancreatitis, healthy controls, and a standard reference. In total, 630 core-fucosylation sites were identified from 322 CF proteins in pancreatic cancer patient serum using an Orbitrap Elite mass spectrometer. Further data analysis revealed that 8 CF peptides exhibited a significant difference between pancreatic cancer and other controls, which may be potential diagnostic biomarkers for pancreatic cancer.

  8. Recurrent suicide attempt and female hormones

    PubMed Central

    Mousavi, Seyed Ghafur; Bateni, Shima; Maracy, Mohammad Reza; Mardanian, Farahnaz; Mousavi, Seyedeh Hakimeh

    2014-01-01

    Background: Because of more frequency of suicidal attempts in females, we need to study about its relationship with the female hormones. The aim of this study was to evaluate the serum estrogen and progesterone concentration and their relationship with suicidal attempt ranking in the attempted females. Materials and Methods: The studied cases chose from patients who had referred to clinical toxicology emergency of Noor Hospital (Isfahan, Iran), during 2012, because of suicidal attempt. The estrogen and progesterone serum level of the 111 females were measured during 24 hours after suicidal attempt. The rank of their suicide, the demographic properties, and the menstrual cycle phase of them were also registered, as the patient's statement. The results were analyzed by ANCOVA and Kruscal-Wallis under SPSS16. Results: Mean serum concentration of the estrogen was 76.8 pg/mL, and the mean serum concentration of progesterone was 2.99 ng/mL. Of them, 62.2% were in the luteal phase, and 37.8% were in the follicular phase, as they said. The serum progesterone concentration of the patients with more than two times suicidal attempts was significantly higher than the others. Conclusion: The suicidal attempt ranks significantly related to the serum progesterone concentration and the luteal phase. PMID:25337531

  9. Serum and CSF soluble CD26 and CD30 concentrations in healthy pediatric surgical outpatients.

    PubMed

    Delezuch, W; Marttinen, P; Kokki, H; Heikkinen, M; Vanamo, K; Pulkki, K; Matinlauri, I

    2012-10-01

    Activated T-helper type 1 (Th1) lymphocytes induce a cellular type immune response, and Th2 lymphocytes, a humoral or antibody-mediated type immune response. Soluble CD26 (sCD26) and soluble CD30 (sCD30) are regarded as markers of Th1 and Th2 lymphocyte activation, respectively. Serum from 112 generally healthy pediatric surgical patients and cerebrospinal fluid (CSF) from 39, aged 1-17 years were measured for sCD26 and sCD30 using an enzyme-linked immunosorbent assay method. The detection limit for sCD26 was 6.8 ng/ml and for sCD30, 1.9 IU/ml. For serum sCD26 and sCD30, 2.5% and 97.5% percentiles constituted the reference limits, and the 95% credible intervals for the percentiles were calculated using regression models with a Bayesian approach. A significant between-gender difference was observed (P = 0.015) in serum sCD26 concentration, of which the lower limits ranged between 273 and 716 ng/ml for girls and 235 and 797 ng/ml for boys. The upper limits ranged between 1456 and 1898 ng/ml for girls and between 1419 and 1981 ng/ml for boys. Moreover, the concentrations of sCD26 increased in infants and children up to 10 years in girls and 12 years in boys. After this however, the values decreased. The serum sCD30 concentration was highest among the youngest infants aged 1 year (80-193 IU/ml), after which a consistent age-related decrease was found. The lowest values were found at the age of 17 years (10-89 IU/ml). A significant between-gender difference in sCD30 concentration was observed (P = 0.019). sCD26 and sCD30 concentrations were low in the CSF samples analyzed: 13.3 ng/ml (median); range 8.3-51.5 ng/ml and 7.6 IU/ml; 2.1-18.5 IU/ml, respectively. Reference limits for serum sCD26 in children aged 1-17 years were established as being 235-1800 ng/ml in toddlers and 400-1800 ng/ml in female adolescents and 700-2000 ng/ml in male adolescents. For sCD30; reference limits of 80-190 IU/ml were established in the youngest age group and 10-90 IU/ml in adolescents. © 2012 John Wiley & Sons A/S.

  10. Multiphoton fluorescence spectra and lifetimes of biliverdins and their protein-associated complex

    NASA Astrophysics Data System (ADS)

    Huang, Chin-Jie; Wu, Cheng-Ham; Liu, Tzu-Ming

    2012-03-01

    To investigate whether endogenous biliverdins can serve as a fluorescence metabolic marker in cancer diagnosis, we measured their multiphoton fluorescence spectra and lifetimes with femtosecond Cr:forsterite laser. Excited at 1230nm, the two-photon fluorescence of biliverdins peaks around 670nm. The corresponding lifetime (<100ps) was much shorter than those of porphyrins (~10ns), which is another commonly present metabolites in living cells. Further mixing biliverdins with proteins like fetal bovine serum (FBS), biliverdins reductase A (BVRA), or heme oxygenase-1 (HO-1), the yields of red autofluorescences didn't change a lot, but the corresponding lifetimes with HO-1 and BSA were lengthened to 200~300ps. This indicates that biliverdin can have an association with these proteins and change its lifetime. These spectral and temporal characteristics of fluorescence make biliverdin a potential marker fluorophore for hyperspectral diagnosis on the heme catabolism in human cells or tissues.

  11. The effects of tissue-non-specific alkaline phosphatase gene therapy on craniosynostosis and craniofacial morphology in the FGFR2C342Y/+ mouse model of Crouzon craniosynostosis.

    PubMed

    Wang, E; Nam, H K; Liu, J; Hatch, N E

    2015-04-01

    Craniosynostosis, the premature fusion of cranial bones, has traditionally been described as a disease of increased bone mineralization. However, multiple mouse models of craniosynostosis display craniosynostosis simultaneously with diminished cranial bone volume and/or density. We propose an alternative hypothesis that craniosynostosis results from abnormal tissue mineralization through the downregulation of tissue-non-specific alkaline phosphatase (TNAP) enzyme downstream of activating mutations in FGFRs. Neonatal Crouzon (FGFRC342Y/+) and wild-type (FGFR+/+) mice were injected with lentivirus to deliver a recombinant form of TNAP. Mice were sacrificed at 4 weeks postnatal. Serum was collected to test for alkaline phosphatase (AP), phosphorus, and calcium levels. Craniofacial bone fusion and morphology were assessed by micro-computed tomography. Injection with the TNAP lentivirus significantly increased serum AP levels (increased serum AP levels are indicative of efficient transduction and production of the recombinant protein), but results were variable and dependent upon viral lot and the litter of mice injected. Morphological analysis revealed craniofacial form differences for inferior surface (p=0.023) and cranial height (p=0.014) regions between TNAP lentivirus-injected and vehicle-injected Crouzon mice. With each unit increase in AP level, the odds of lambdoid suture fusion decreased by 84.2% and these results came close to statistical significance (p=0.068). These results suggest that TNAP deficiency may mediate FGFR2-associated craniosynostosis. Future studies should incorporate injection of recombinant TNAP protein, to avoid potential side effects and variable efficacy of lentiviral gene delivery. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  12. Optofluidic ring resonator sensor for sensitive label-free detection of breast cancer antigen CA15-3 in human serum

    NASA Astrophysics Data System (ADS)

    Zhu, Hongying; Dale, Paul S.; Fan, Xudong

    2009-05-01

    Breast cancer is the most frequently diagnosed malignancy in women worldwide. Because of its great impact on society, a lot of research funding has been used to develop novel detection tools for aiding breast cancer diagnosis and prognosis. In this work, we demonstrated a simple, fast, and sensitive detection of circulating breast cancer biomarker CA15-3 with opto-fluidic ring resonator (OFRR) sensors. The OFRR sensor employs a thin-walled capillary with wall thickness less than 4 μm. The circular cross section of the capillary forms the optical ring resonator, in which the light circulates in the form of whispering gallery modes (WGMs). The capillary wall is thin enough that the evanescent field of the WGM extends into the capillary core and responds to refractive index changes in the capillary core or close to its interior surface. The WGM spectral position will change when the biomolecules bind to the surface, yielding quantitative and kinetic information about the biomolecule interaction. Here, the direct immunoassay method was employed for the detection of CA15-3 antigen without any signal amplification steps. The sensor performance in both PBS buffer and human serum were investigated, respectively. The experimental detection limit was 5 units/mL in PBS buffer and 30 units/mL for CA15-3 spiked in serum, both of which satisfied clinical diagnosis requirements. The potential use of the OFRR as the point-of-care device for breast cancer detection was tested by measuring the CA15-3 level in blood samples collected from stage IV breast cancer patients and the results were compared with standard clinical test.

  13. 7 CFR 201.30b - Lot number or other lot identification of vegetable seed in containers of more than 1 pound.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 3 2012-01-01 2012-01-01 false Lot number or other lot identification of vegetable seed in containers of more than 1 pound. 201.30b Section 201.30b Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED)...

  14. 7 CFR 201.30b - Lot number or other lot identification of vegetable seed in containers of more than 1 pound.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 3 2011-01-01 2011-01-01 false Lot number or other lot identification of vegetable seed in containers of more than 1 pound. 201.30b Section 201.30b Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED)...

  15. 7 CFR 201.30b - Lot number or other lot identification of vegetable seed in containers of more than 1 pound.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 3 2013-01-01 2013-01-01 false Lot number or other lot identification of vegetable seed in containers of more than 1 pound. 201.30b Section 201.30b Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED)...

  16. 7 CFR 201.30b - Lot number or other lot identification of vegetable seed in containers of more than 1 pound.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Lot number or other lot identification of vegetable seed in containers of more than 1 pound. 201.30b Section 201.30b Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED)...

  17. 7 CFR 201.30b - Lot number or other lot identification of vegetable seed in containers of more than 1 pound.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 3 2014-01-01 2014-01-01 false Lot number or other lot identification of vegetable seed in containers of more than 1 pound. 201.30b Section 201.30b Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED)...

  18. Effects of greening and community reuse of vacant lots on crime

    Treesearch

    M. Kondo; B. Hohl; S. Han; C. Branas

    2016-01-01

    The Youngstown Neighborhood Development Corporation initiated a ‘Lots of Green’ programme to reuse vacant land in 2010. We performed a difference-in-differences analysis of the effects of this programme on crime in and around newly treated lots, in comparison to crimes in and around randomly selected and matched, untreated vacant lot controls. The effects of two types...

  19. 76 FR 30745 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-26

    ... Change Amending Its Rules To Remove the Concept of an ``Odd Lot Dealer'' May 19, 2011. Pursuant to... remove the concept of an ``Odd Lot Dealer.'' The text of the proposed rule change is available at the... proposes to amend its rules to remove the concept of an Odd Lot Dealer. An Odd Lot Dealer is any Market...

  20. Neighborhood blight, stress, and health: a walking trial of urban greening and ambulatory heart rate

    Treesearch

    Eugenia C. South; Michelle C. Kondo; Rose A. Cheney; Charles C. Branas

    2015-01-01

    We measured dynamic stress responses using ambulatory heart rate monitoring as participants in Philadelphia, Pennsylvania walked past vacant lots before and after a greening remediation treatment of randomly selected lots. Being in view of a greened vacant lot decreased heart rate significantly more than did being in view of a nongreened vacant lot or not in view of...

  1. Evaluation of serum cobalamin concentrations in dogs of 164 dog breeds (2006-2010).

    PubMed

    Grützner, Niels; Cranford, Shannon M; Norby, Bo; Suchodolski, Jan S; Steiner, Jörg M

    2012-11-01

    Altered serum cobalamin concentrations have been observed in dogs with gastrointestinal disorders such as exocrine pancreatic insufficiency (EPI) or gastrointestinal inflammation. The aims of the current study were 1) to identify breeds with a higher proportion of dogs with a decreased serum cobalamin concentration, 2) to determine whether dogs with such decreased concentrations tend to have serum canine trypsin-like immunoreactivity (cTLI) concentrations diagnostic for EPI, and 3) to compare the number of submissions for serum cobalamin analysis by breed to the American Kennel Club (AKC) breed ranking list of 2009. In this retrospective study, results of 28,675 cobalamin tests were reviewed. Akitas, Chinese Shar-Peis, German Shepherd Dogs, Greyhounds, and Labrador Retrievers had increased proportions of serum cobalamin concentrations below the lower limit of the reference interval (<251 ng/l; all P < 0.0001). Akitas, Chinese Shar-Peis, German Shepherd Dogs, and Border Collies had increased proportions of serum cobalamin concentrations below the detection limit of the assay (<150 ng/l; all P < 0.0001). Akitas, Border Collies, and German Shepherd Dogs with serum cobalamin concentrations <150 ng/l were more likely to have a serum cTLI concentration considered diagnostic for EPI (≤2.5 µg/l; all P ≤ 0.001). The breed with the highest proportion of samples submitted for serum cobalamin analysis in comparison with the AKC ranking list was the Greyhound (odds ratio: 84.6; P < 0.0001). In Akitas and Border Collies, further investigations are warranted to clarify if a potentially breed-specific gastrointestinal disorder is responsible for the increased frequency of decreased serum cobalamin and cTLI concentrations.

  2. Comparison of biochemical values in serum and plasma, fresh and frozen plasma, and hemolyzed samples from orange-winged Amazon parrots (Amazona amazonica).

    PubMed

    Hawkins, Michelle G; Kass, Philip H; Zinkl, Joseph G; Tell, Lisa A

    2006-06-01

    To the authors' knowledge, on the basis of sample type, storage condition, or hemolysis, differences in serum and plasma biochemical values have not been evaluated in orange-winged Amazon parrots (Amazona amazonica). The purpose of this study was to compare values for biochemical analytes in serum vs plasma, fresh vs frozen plasma, and nonhemolyzed vs hemolyzed samples in orange-winged Amazon parrots. We also compared differences in serum and plasma yield from whole-blood aliquots. Fifteen biochemical analytes were evaluated in paired serum and plasma, fresh and frozen plasma, nonhemolyzed and hemolyzed serum and plasma samples from orange-winged Amazon parrots (n = 10) using a wet reagent analyzer. Hemolysis was assessed qualitatively (visually) and quantitatively (hemoglobin [Hgb] measured spectrophotometrically). Serum and plasma yields from 500-microl whole-blood aliquots were determined from centrifuged samples. Analyte values significantly differed among sample groups, but were still within published reference intervals, with the exception of increases in potassium concentration in markedly hemolyzed serum and plasma samples. Clinically important changes in hemolyzed serum and plasma samples included increases in potassium, phosphorus, and albumin concentrations and lactate dehydrogenase activity. The degree of hemolysis assigned qualitatively did not correlate with quantitative Hgb concentration. A significantly greater yield of plasma (288 +/- 13 microL) than serum (241 +/- 44 microL) was obtained. Significant differences may occur in different sample types, however, only changes in potassium, phosphorus, albumin, and lactate dehydrogenase values in hemolyzed samples were considered clinically relevant. Lack of agreement between qualitative and quantitative Hgb concentration indicates the unreliability of visual estimation. Based on higher sample yield, and lack of clinically relevant differences from serum, plasma is a better sample choice for clinical chemistry analysis in birds.

  3. Parathyroid hormone related protein concentration in human serum and CSF correlates with age.

    PubMed

    Kushnir, Mark M; Peterson, Lisa K; Strathmann, Frederick G

    2018-02-01

    Parathyroid Hormone-Related Protein (PTHrP) is involved in intracellular calcium (Ca) regulation, and has been demonstrated to participate in regulation of Ca in brain cells, activation of neurons, and modulation of pain. However, there are conflicting reports regarding the presence of PTHrP in CSF. PTHrP and Ca were quantified in paired CSF and serum samples using mass spectrometry-based methods. Associations between PTHrP and Ca concentrations with age, sex and concentrations of nine CSF diagnostic markers in a set of 140 paired serum and CSF patient samples were evaluated. The observed median PTHrP concentration in CSF was 51 times higher than in serum; the median concentration of Ca in CSF was 1.8 times lower than in serum. We observed positive correlation between concentrations of PTHrP in CSF and serum (p=0.013). Distribution of PTHrP concentrations in serum was associated with age (p=0.0068) and the concentrations were higher in women. In samples with serum calcium concentrations within the reference intervals (n=118), central 95% distribution of concentrations for Ca-CSF, PTHrP-serum and PTHrP-CSF were 5.4 (4.5-6.1) mg/dL, 1.2 (0.5-2.5) pmol/L, 62 (22-125) pmol/L, respectively. Our data demonstrate that PTHrP is a normal constituent of human CSF with median concentrations 51 fold higher than in serum. Elevated serum PTHrP concentrations were positively correlated with age and significantly higher in women. Our data suggest that CSF could be a significant source of circulating PTHrP. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  4. Association between serum uric acid levels and obesity among university students (China).

    PubMed

    Duan, Ying; Liang, Wei; Zhu, Lijun; Zhang, Ting; Wang, Linghong; Nie, Zhognhua; Chen, Yan; He, Lianping; Jin, Yuelong; Yao, Yingshui

    2015-06-01

    To evaluate the association between serum uric acid and obesity among university students who participated in routine health screening in 2013. In this cross-sectional study, 3529 subjects were analyzed. Obesity categories were classified by BMI levels references in China. And serum uric acid levels were classified by serum uric acid quartiles. Two-sample T-test and Wilcoxon Rank sum test were used to compare age, biochemical and anthropometric parameters of subjects of two genders. Rank correlation used to analyze relationship between serum uric acid and obesity. There were 1285 males (mean age, 19.8 ± 1.3 years) and 2244 females (mean age, 19.9 ± 1.3 years) in this study. Association between 2nd serum uric acid quartile and normal in male are significant and coefficient was 0.519. The 3rd serum uric acid quartile and normal in female was associated significantly (r = 0.173, p = 0.010). And associations between overweight and 3rd and 4th serum uric acid quartiles in female were significant (r = 0.128, p = 0.038 in 1st quartile and r = 0.282, p = 0.004 in 4th quartile). The 4th serum uric acid quartile and Obesity in two gender groups were significantly associated (r = 0.291, p = 0.000 in male and r = 0.484, p = 0.001 in female). High serum uric acid was positively associated with obesity in overweight and obesity group. However, the association was weak between two variables because serum uric acid influenced obesity with other related factors together. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

  5. Interpreting magnesium status to enhance clinical care: key indicators.

    PubMed

    Costello, Rebecca B; Nielsen, Forrest

    2017-11-01

    To update advances in identifying factors affecting magnesium (Mg) status that assist in providing improved evidence-based clinical decision-making for assessing Mg status. Findings from recent cohort studies, small randomized control trials, and multiple meta-analyses reinforce earlier work that serum Mg concentrations, urinary Mg excretion, and Mg dietary intakes are inversely associated with cardiovascular disease, chronic kidney disease, and diabetes. These studies indicate that the reference range for serum Mg needs updating, and that individuals with serum Mg in the range of 0.75-0.85 mmol/l and displaying changes in other factors associated with a low Mg status may be Mg deficient. Individuals with serum Mg concentrations below this range most likely are Mg deficient and, above this range, are most likely Mg sufficient. The combined determination of serum Mg concentration, 24-h urinary Mg excretion, and dietary Mg intake is currently the most practical method to obtain a sound assessment of Mg status. The strong correlations of Mg deficiency with increased risk of several chronic diseases, some of which exist as comorbidities, indicate that Mg status should be ascertained in patients presenting such disorder.

  6. EDRN Breast and Ovary Cancer CVC, Study 4: Phase 3 Validation of Ovarian Cancer Serum Markers in Preclinical WHI Samples — EDRN Public Portal

    Cancer.gov

    The WHI offers an opportunity to evaluate ovarian cancer markers and screening decision rules developed and validated in EDRN CVC Studies 2 and 3 in women who were not being screened. It is particularly well suited to validation of risk markers, since many serum samples were drawn well before clinical diagnosis of cancer in the WHI cohorts. A strategy is needed to identify from among the general population of women over the age of 50 those at high-risk for a diagnosis of ovarian/fallopian tube cancer so that they can be referred for appropriate surveillance, imaging or surgical consult. Tools to identify high-risk women will be investigated including serum markers CA125, HE4, MSLN, and MMP7 and epidemiologic risk factors. We will optimize decision rules using stored serum samples from the WHI OS and conduct a simulated prospective validation using stored serum samples from the WHI CT. Decision rules to select women for ovarian cancer screening will be investigated as well as decision rules for use in ovarian cancer screening.

  7. Effect of Soybean Casein Digest Agar Lot on Number of Bacillus stearothermophilus Spores Recovered †

    PubMed Central

    Pflug, I. J.; Smith, Geraldine M.; Christensen, Ronald

    1981-01-01

    In recent years it has become increasingly apparent that Bacillus stearothermophilus spores are affected by various environmental factors that influence the performance of the spores as biological indicators. One environmental factor is the recovery medium. The effect of different lots of commercial soybean casein digest agar on the number of colony-forming units per plate was examined in two series of experiments: (i) several lots of medium from two manufacturers were compared in single experiments, and (ii) paired media experiments with four lots of medium were carried out and yielded three-point survivor curves. The results demonstrate that commercial soybean casein digest agar is variable on a lot-to-lot basis. The variation was lowest when recovering unheated or minimally heated spores and increased greatly with the severity of heating. PMID:16345822

  8. Parking lot sealcoat: An unrecognized source of urban polycyclic aromatic hydrocarbons

    USGS Publications Warehouse

    Mahler, B.J.; Van Metre, P.C.; Bashara, T.J.; Wilson, J.T.; Johns, D.A.

    2005-01-01

    Polycyclic aromatic hydrocarbons (PAHs) are a ubiquitous contaminant in urban environments. Although numerous sources of PAHs to urban runoff have been identified, their relative importance remains uncertain. We show that a previously unidentified source of urban PAHs, parking lot sealcoat, may dominate loading of PAHs to urban water bodies in the United States. Particles in runoff from parking lots with coal-tar emulsion sealcoat had mean concentrations of PAHs of 3500 mg/kg, 65 times higher than the mean concentration from unsealed asphalt and cement lots. Diagnostic ratios of individual PAHs indicating sources are similar for particles from coal-tar emulsion sealed lots and suspended sediment from four urban streams. Contaminant yields projected to the watershed scale for the four associated watersheds indicate that runoff from sealed parking lots could account for the majority of stream PAH loads.

  9. A Transcultural Model of the Centrality of "Thinking a Lot" in Psychopathologies Across the Globe and the Process of Localization: A Cambodian Refugee Example.

    PubMed

    Hinton, Devon E; Barlow, David H; Reis, Ria; de Jong, Joop

    2016-12-01

    We present a general model of why "thinking a lot" is a key presentation of distress in many cultures and examine how "thinking a lot" plays out in the Cambodian cultural context. We argue that the complaint of "thinking a lot" indicates the presence of a certain causal network of psychopathology that is found across cultures, but that this causal network is localized in profound ways. We show, using a Cambodian example, that examining "thinking a lot" in a cultural context is a key way of investigating the local bio-cultural ontology of psychopathology. Among Cambodian refugees, a typical episode of "thinking a lot" begins with ruminative-type negative cognitions, in particular worry and depressive thoughts. Next these negative cognitions may induce mental symptoms (e.g., poor concentration, forgetfulness, and "zoning out") and somatic symptoms (e.g., migraine headache, migraine-like blurry vision such as scintillating scotomas, dizziness, palpitations). Subsequently the very fact of "thinking a lot" and the induced symptoms may give rise to multiple catastrophic cognitions. Soon, as distress escalates, in a kind of looping, other negative cognitions such as trauma memories may be triggered. All these processes are highly shaped by the Cambodian socio-cultural context. The article shows that Cambodian trauma survivors have a locally specific illness reality that centers on dynamic episodes of "thinking a lot," or on what might be called the "thinking a lot" causal network.

  10. Studies of an alpha-fetoprotein assay using dry blood-spot samples to be used for the detection of fetal neural tube defects.

    PubMed

    Wong, P Y; Mee, A V; Doran, T A

    1982-06-01

    We modified the Pharmacia serum alpha-fetoprotein (AFP) kit to enable its use with dry blood-spots on filter paper. Reference values were established for blood from 253 women in the 16th to 18th weeks of gestation. The result by the present technique in a woman with a confirmed anencephalic fetus was elevated, and in agreement with the results of AFP assays in serum and amniotic fluid. Blood AFP was stable on dried filter paper sent by mail.

  11. Serum TSH within the reference range as a predictor of future hypothyroidism and hyperthyroidism: 11-year follow-up of the HUNT Study in Norway.

    PubMed

    Åsvold, Bjørn O; Vatten, Lars J; Midthjell, Kristian; Bjøro, Trine

    2012-01-01

    Serum TSH in the upper part of the reference range may sometimes be a response to autoimmune thyroiditis in early stage and may therefore predict future hypothyroidism. Conversely, relatively low serum TSH could predict future hyperthyroidism. The objective of the study was to assess TSH within the reference range and subsequent risk of hypothyroidism and hyperthyroidism. This was a prospective population-based study with linkage to the Norwegian Prescription Database. A total of 10,083 women and 5,023 men without previous thyroid disease who had a baseline TSH of 0.20-4.5 mU/liter and who participated at a follow-up examination 11 yr later. Predicted probabilities of developing hypothyroidism or hyperthyroidism during follow-up, by categories of baseline TSH, were estimated. During 11 yr of follow-up, 3.5% of women and 1.3% of men developed hypothyroidism, and 1.1% of women and 0.6% of men developed hyperthyroidism. In both sexes, the baseline TSH was positively associated with the risk of subsequent hypothyroidism. The risk increased gradually from TSH of 0.50-1.4 mU/liter [women, 1.1%, 95% confidence interval (CI) 0.8-1.4; men, 0.3%, 95% CI 0.1-0.6] to a TSH of 4.0-4.5 mU/liter (women, 31.5%, 95% CI 24.6-39.3; men, 14.7%, 95% CI 7.7-26.2). The risk of hyperthyroidism was higher in women with a baseline TSH of 0.20-0.49 mU/liter (3.9%, 95% CI 1.8-8.4) than in women with a TSH of 0.50-0.99 mU/liter (1.4%, 95% CI 0.9-2.1) or higher (∼1.0%). TSH within the reference range is positively and strongly associated with the risk of future hypothyroidism. TSH at the lower limit of the reference range may be associated with an increased risk of hyperthyroidism.

  12. 24 CFR 1715.20 - Unlawful sales practices-regulatory provisions.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... septic tank operation or there is reasonable assurance that the lot can be served by a central sewage system; (3) The lot is legally accessible; and (4) The lot is free from periodic flooding. ...

  13. 24 CFR 1715.20 - Unlawful sales practices-regulatory provisions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... septic tank operation or there is reasonable assurance that the lot can be served by a central sewage system; (3) The lot is legally accessible; and (4) The lot is free from periodic flooding. ...

  14. 24 CFR 1715.20 - Unlawful sales practices-regulatory provisions.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... septic tank operation or there is reasonable assurance that the lot can be served by a central sewage system; (3) The lot is legally accessible; and (4) The lot is free from periodic flooding. ...

  15. 24 CFR 1715.20 - Unlawful sales practices-regulatory provisions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... septic tank operation or there is reasonable assurance that the lot can be served by a central sewage system; (3) The lot is legally accessible; and (4) The lot is free from periodic flooding. ...

  16. Serum biochemical reference intervals for free-living Sand Tiger sharks (Carcharias taurus) from east Australian waters.

    PubMed

    Otway, Nicholas M

    2015-06-01

    Sharks are top-order predators in ocean food chains and the star attractions in aquaria worldwide. Unfortunately, blood biochemistry reference intervals (RI) have been determined for few species. The study aims to establish serum biochemical RI for free-living Sand Tiger sharks (Carcharias taurus) off eastern Australia. Thirty-seven sharks were captured and their sex, length, weight, reproductive maturity, and health status were recorded. After blood collection, serum analytes were quantified using standard analytical and statistical methods. Reference intervals, means, medians, and 90% confidence intervals were generated. Physiologic data from live and necropsied sharks were used to enhance the study results. Thirty healthy sharks were included in the study. Albumin could not be detected. With the exception of ALP activity, values were unaffected by sex, length, weight, age, and life-history stage. The means (RI) were: sodium 258 (249-267) mmol/L, potassium 5.0 (4.3-5.7) mmol/L, chloride 242 (227-257) mmol/L, inorganic phosphate 1.8 (1.7-2.0) mmol/L, total calcium 3.9 (3.3-4.4) mmol/L, magnesium 1.9 (1.6-2.2) mmol/L, glucose 2.7 (2.2-3.2) mmol/L, urea 377 (360-394) mmol/L, ALP 20 (8-31) U/L, ALT 3 U/L (no RI), AST 29 (13-45) U/L, CK 42 (5-79) U/L, total protein 30 (24-36) g/L, triglyceride 0.3 (0.1-0.6) mmol/L, cholesterol 1.4 (0.9-2.1) mmol/L, creatinine 32 μmol/L (no RI), total bilirubin 1.5 μmol/L (no RI), and osmolarity 1082 (1027-1136) mmol/L. These preliminary RI will assist with the clinical evaluation and treatment of captive and free-living Sand Tiger sharks worldwide. Studies with more animals will increase the precision of upper and lower reference limits. © 2015 American Society for Veterinary Clinical Pathology.

  17. Utility of serum IGF-1 for diagnosis of growth hormone deficiency following traumatic brain injury and sport-related concussion.

    PubMed

    Lithgow, Kirstie; Chin, Alex; Debert, Chantel T; Kline, Gregory A

    2018-04-02

    Growth hormone deficiency (GHD) is a potential consequence of traumatic brain injury (TBI), including sport-related concussion (SRC). GH stimulation testing is required for definitive diagnosis; however, this is resource intensive and can be associated with adverse symptoms or risks. Measurement of serum IGF-1 is more practical and accessible, and pituitary tumour patients with hypopituitarism and low serum IGF-1 have been shown to have a high probability of GHD. We aimed to evaluate IGF-1 measurement for diagnosing GHD in our local TBI population. We conducted a retrospective chart review of patients evaluated for GHD at the TBI clinic and referred for GH stimulation testing with insulin tolerance test (ITT) or glucagon stimulation test (GST) since December 2013. We obtained demographics, TBI severity, IGF-1, data pertaining to pituitary function, and GH stimulation results. IGF-1 values were used to calculate z-scores per age and gender specific reference ranges. Receiver operator curve analysis was performed to evaluate diagnostic threshold of IGF-1 z-score for determining GHD by GST or ITT. Sixty four patient charts were reviewed. 48 patients had mild, six had moderate, eight had severe TBI, and two had non-traumatic brain injuries. 47 patients underwent ITT or GST. 27 were confirmed to have GHD (peak hGH < 5 μg/L). IGF-1 level was within the age and gender specific reference range for all patients with confirmed GHD following GH stimulation testing. Only one patient had a baseline IGF-1 level below the age and gender specific reference range; this patient had a normal response to GH stimulation testing. ROC analysis showed IGF-1 z-score AUC f, confirming lack of diagnostic utility. Baseline IGF-1 is not a useful predictor of GHD in our local TBI population, and therefore has no value as a screening tool. TBI patients undergoing pituitary evaluation will require a dynamic test of GH reserve.

  18. Reference values for biochemical parameters in blood serum of young and adult alpacas (Vicugna pacos).

    PubMed

    Husakova, T; Pavlata, L; Pechova, A; Hauptmanova, K; Pitropovska, E; Tichy, L

    2014-09-01

    The aim of this study was to establish reference interval for biochemical parameters in blood of alpacas on the basis of large population of clinically healthy animals, and to determine the influence of sex, age and season on nitrogen and lipid metabolites, enzymes, electrolytes, vitamins and minerals in blood of alpacas. Blood samples were collected from 311 alpacas (61 males and 201 females >6 months of age and 49 crias (21 males and 28 females) ⩽6 months of age). Selected farms were located in Central Europe (Czech Republic and Germany). We determined 24 biochemical parameters from blood serum. We performed the comparison of results by the sex of animals and for the older group also the comparison of the results with regard to the season, respectively, to the feeding period. We found no highly significant difference (P<0.01) between males and females with the exception of γ-glutamyl transferase (GGT), alkaline phosphatase (ALP) and cholesterol. We found 15 significantly different parameters between the group of crias 6 months of age and the older alpacas. Based on our findings we suggest for most parameters to use different reference intervals (especially ALP, cholesterol, total protein, globulin, non-esterified fatty acids (NEFA), GGT and phosphorus) for the two above-mentioned age groups. Another important finding is the differences between some parameters in older group of alpacas in summer/winter feeding period. Animals in the summer feeding period have higher values of parameters related to fat mobilization (β-hydroxybutyrate, NEFA) and liver metabolism (bilirubin, alanine aminotransferase). The winter period with increased feeding of supplements with higher amount of fat, vitamins and minerals is characteristic by increased values of cholesterol, triglycerides, vitamins A and E, and some minerals (K, Ca, Mg and Cl) in blood serum. Clinical laboratory diagnosis of metabolic disturbances may be improved with use of age-based reference values and with consideration of seasonal differences.

  19. 7 CFR 33.7 - Less than carload lot.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... ISSUED UNDER AUTHORITY OF THE EXPORT APPLE ACT Definitions § 33.7 Less than carload lot. Less than carload lot means a quantity of apples in packages not exceeding 20,000 pounds gross weight or 400...

  20. 7 CFR 33.7 - Less than carload lot.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... ISSUED UNDER AUTHORITY OF THE EXPORT APPLE ACT Definitions § 33.7 Less than carload lot. Less than carload lot means a quantity of apples in packages not exceeding 20,000 pounds gross weight or 400...

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