Comparison of multianalyte proficiency test results by sum of ranking differences, principal component analysis, and hierarchical cluster analysis.

PubMed

Škrbić, Biljana; Héberger, Károly; Durišić-Mladenović, Nataša

2013-10-01

Sum of ranking differences (SRD) was applied for comparing multianalyte results obtained by several analytical methods used in one or in different laboratories, i.e., for ranking the overall performances of the methods (or laboratories) in simultaneous determination of the same set of analytes. The data sets for testing of the SRD applicability contained the results reported during one of the proficiency tests (PTs) organized by EU Reference Laboratory for Polycyclic Aromatic Hydrocarbons (EU-RL-PAH). In this way, the SRD was also tested as a discriminant method alternative to existing average performance scores used to compare mutlianalyte PT results. SRD should be used along with the z scores--the most commonly used PT performance statistics. SRD was further developed to handle the same rankings (ties) among laboratories. Two benchmark concentration series were selected as reference: (a) the assigned PAH concentrations (determined precisely beforehand by the EU-RL-PAH) and (b) the averages of all individual PAH concentrations determined by each laboratory. Ranking relative to the assigned values and also to the average (or median) values pointed to the laboratories with the most extreme results, as well as revealed groups of laboratories with similar overall performances. SRD reveals differences between methods or laboratories even if classical test(s) cannot. The ranking was validated using comparison of ranks by random numbers (a randomization test) and using seven folds cross-validation, which highlighted the similarities among the (methods used in) laboratories. Principal component analysis and hierarchical cluster analysis justified the findings based on SRD ranking/grouping. If the PAH-concentrations are row-scaled, (i.e., z scores are analyzed as input for ranking) SRD can still be used for checking the normality of errors. Moreover, cross-validation of SRD on z scores groups the laboratories similarly. The SRD technique is general in nature, i.e., it can be applied to any experimental problem in which multianalyte results obtained either by several analytical procedures, analysts, instruments, or laboratories need to be compared.

Accuracy of p53 Codon 72 Polymorphism Status Determined by Multiple Laboratory Methods: A Latent Class Model Analysis

PubMed Central

Walter, Stephen D.; Riddell, Corinne A.; Rabachini, Tatiana; Villa, Luisa L.; Franco, Eduardo L.

2013-01-01

Introduction Studies on the association of a polymorphism in codon 72 of the p53 tumour suppressor gene (rs1042522) with cervical neoplasia have inconsistent results. While several methods for genotyping p53 exist, they vary in accuracy and are often discrepant. Methods We used latent class models (LCM) to examine the accuracy of six methods for p53 determination, all conducted by the same laboratory. We also examined the association of p53 with cytological cervical abnormalities, recognising potential test inaccuracy. Results Pairwise disagreement between laboratory methods occurred approximately 10% of the time. Given the estimated true p53 status of each woman, we found that each laboratory method is most likely to classify a woman to her correct status. Arg/Arg women had the highest risk of squamous intraepithelial lesions (SIL). Test accuracy was independent of cytology. There was no strong evidence for correlations of test errors. Discussion Empirical analyses ignore possible laboratory errors, and so are inherently biased, but test accuracy estimated by the LCM approach is unbiased when model assumptions are met. LCM analysis avoids ambiguities arising from empirical test discrepancies, obviating the need to regard any of the methods as a “gold” standard measurement. The methods we presented here to analyse the p53 data can be applied in many other situations where multiple tests exist, but where none of them is a gold standard. PMID:23441193

Interlaboratory comparison of mutagenesis testing of coal fly ash derived from differenct coal conversion technologies

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

Chrisp, C.; Hobbs, C.; Clark, R.

1979-01-01

This experiment showed that mutagenicity of fly ash derived from different coal conversion technologies, as determined by the Ames plate incorporation test, was similar in all three laboratories. The differences in mutagenic activity of each fly ash between laboratories with different solvent extraction methods were no greater than one order of magnitude. In addition, there were much smaller, but still significant differences in mutagenic activity between laboratories when the same solvent extract of a particular fly ash was tested in each laboratory. There were also significant differences in mutagenicity of the positive control mutagen (maximum of fivefold) between laboratories. Becausemore » of this difference in Ames test sensitivity between laboratories, the influence of the solvent extraction methods on differences in mutagenicity was not clear. However, the data suggested that either there were significant differences in the degree of sensitivity of Ames tests for different complex mixtures within each laboratory, or else there were differences in mutagen extraction efficiency between different solvent extraction methods. Both Ames test sensitivity and solvent extraction may be important. Further work would be necessary to separate the contribution of these two factors. An important aspect of further work would be to separate the contribution of the innate sensitivity of substrains of Ames tester strains in each laboratory from the possible effects of differences in Ames testing methodology. This could be done by testing the same extracts of fly ash and positive control mutagens with substrains of tester strains exchanged between laboratories. This work also implies that caution should be exercised in assuming that the same solvent would have the same efficiency for extraction of mutagens from different fly ashes even within the same laboratory.« less

INTER LABORATORY COMBAT HELMET BLUNT IMPACT TEST METHOD COMPARISON

DTIC Science & Technology

2018-03-26

HELMET BLUNT IMPACT TEST METHOD COMPARISON by Tony J. Kayhart Charles A. Hewitt and Jonathan Cyganik March 2018 Final...Report March 2016 – August 2017 Approved for public release; distribution is unlimited U.S. Army Natick Soldier Research ...INTER-LABORATORY COMBAT HELMET BLUNT IMPACT TEST METHOD COMPARISON 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR

Thermal comfort of aeroplane seats: influence of different seat materials and the use of laboratory test methods.

PubMed

Bartels, Volkmar T

2003-07-01

This study determined the influence of different cover and cushion materials on the thermal comfort of aeroplane seats. Different materials as well as ready made seats were investigated by the physiological laboratory test methods Skin Model and seat comfort tester. Additionally, seat trials with human test subjects were performed in a climatic chamber. Results show that a fabric cover produces a considerably higher sweat transport than leather. A three-dimensional knitted spacer fabric turns out to be the better cushion alternative in comparison to a moulded foam pad. Results from the physiological laboratory test methods nicely correspond to the seat trials with human test subjects.

Accelerated Colorimetric Micro-assay for Screening Mold Inhibitors

Treesearch

Carol A. Clausen; Vina W. Yang

2014-01-01

Rapid quantitative laboratory test methods are needed to screen potential antifungal agents. Existing laboratory test methods are relatively time consuming, may require specialized test equipment and rely on subjective visual ratings. A quantitative, colorimetric micro-assay has been developed that uses XTT tetrazolium salt to metabolically assess mold spore...

Clinical Laboratories – Production Factories or Specialized Diagnostic Centers

PubMed Central

Tóth, Judit

2016-01-01

Since a large proportion of medical decisions are based on laboratory results, clinical laboratories should meet the increasing demand of clinicians and their patients. Huge central laboratories may process over 10 million tests annually; they act as production factories, measuring emergency and routine tests with sufficient speed and accuracy. At the same time, they also serve as specialized diagnostic centers where well-trained experts analyze and interpret special test results. It is essential to improve and constantly monitor this complex laboratory service, by several methods. Sample transport by pneumatic tube system, use of an advanced laboratory information system and point-of-care testing may result in decreased total turnaround time. The optimization of test ordering may result in a faster and more cost-effective laboratory service. Autovalidation can save time for laboratory specialists, when the analysis of more complex results requires their attention. Small teams of experts responsible for special diagnostic work, and their interpretative reporting according to predetermined principles, may help to minimize subjectivity of these special reports. Although laboratory investigations have become so diversely developed in the past decades, it is essential that the laboratory can provide accurate results relatively quickly, and that laboratory specialists can support the diagnosis and monitoring of patients by adequate interpretation of esoteric laboratory methods. PMID:27683528

Clinical microbiology laboratories do not always detect resistance of Haemophilus influenzae with disk or tablet diffusion methods. Finnish Study Group for Antimicrobial Resistance (FiRe).

PubMed

Manninen, R; Huovinen, P; Nissinen, A

1998-04-01

The performance of disk diffusion testing of Haemophilus influenzae was evaluated in 20 laboratories. Thirteen disk-medium-breakpoint-inoculum modifications were used in Finnish clinical microbiology laboratories. The performance of various methods was evaluated by testing a susceptible control strain and one with non-beta-lactamase-mediated ampicillin resistance 10 times in 16 laboratories. Gaps in millimeters were measured between these two groups of results. The strains were separated by a gap of at least 5 mm in 8/16 laboratories testing ampicillin, in 7/15 laboratories testing cefaclor, in 5/ 16 laboratories testing cefuroxime, and in 15/16 laboratories testing trimethoprim-sulfa. Detection of ampicillin resistance was better with 2.5 microg tablets than with 10 microg disks or 33 microg tablets. For MIC-determinations, 785 isolates and their disk diffusion results were collected. None of the 12 clinical isolates with non-beta-lactamase-mediated ampicillin resistance was detected as resistant in the participating laboratories. The ampicillin and cefaclor results of the isolates were no better even when a laboratory was able to separate the control strains. Cefaclor results were unreliable because of poor disk diffusion-MIC correspondence and incoherent breakpoint references. Interlaboratory variation of the zone diameters caused false intermediate results of cefuroxime-susceptible strains. When ampicillin, cefaclor and cefuroxime were tested, the discrimination of laboratories using disks and tablets was equal, whereas the laboratories using paper disks were better able to detect trimethoprim-sulfa resistance.

Transferability and inter-laboratory variability assessment of the in vitro bovine oocyte fertilization test.

PubMed

Tessaro, Irene; Modina, Silvia C; Crotti, Gabriella; Franciosi, Federica; Colleoni, Silvia; Lodde, Valentina; Galli, Cesare; Lazzari, Giovanna; Luciano, Alberto M

2015-01-01

The dramatic increase in the number of animals required for reproductive toxicity testing imposes the validation of alternative methods to reduce the use of laboratory animals. As we previously demonstrated for in vitro maturation test of bovine oocytes, the present study describes the transferability assessment and the inter-laboratory variability of an in vitro test able to identify chemical effects during the process of bovine oocyte fertilization. Eight chemicals with well-known toxic properties (benzo[a]pyrene, busulfan, cadmium chloride, cycloheximide, diethylstilbestrol, ketoconazole, methylacetoacetate, mifepristone/RU-486) were tested in two well-trained laboratories. The statistical analysis demonstrated no differences in the EC50 values for each chemical in within (inter-runs) and in between-laboratory variability of the proposed test. We therefore conclude that the bovine in vitro fertilization test could advance toward the validation process as alternative in vitro method and become part of an integrated testing strategy in order to predict chemical hazards on mammalian fertility. Copyright © 2015 Elsevier Inc. All rights reserved.

Multi-Laboratory Study of Five Methods for the Determination of Brevetoxins in Shellfish Tissue Extracts.

PubMed

Dickey, Robert W; Plakas, Steven M; Jester, Edward L E; El Said, Kathleen R; Johannessen, Jan N; Flewelling, Leanne J; Scott, Paula; Hammond, Dan G; Van Dolah, Frances M; Leighfield, Tod A; Bottein Dachraoui, Marie-Yasmine; Ramsdell, John S; Pierce, Richard H; Henry, Mike S; Poli, Mark A; Walker, Calvin; Kurtz, Jan; Naar, Jerome; Baden, Daniel G; Musser, Steve M; White, Kevin D; Truman, Penelope; Miller, Aaron; Hawryluk, Timothy P; Wekell, Marleen M; Stirling, David; Quilliam, Michael A; Lee, Jung K

A thirteen-laboratory comparative study tested the performance of four methods as alternatives to mouse bioassay for the determination of brevetoxins in shellfish. The methods were N2a neuroblastoma cell assay, two variations of the sodium channel receptor binding assay, competitive ELISA, and LC/MS. Three to five laboratories independently performed each method using centrally prepared spiked and naturally incurred test samples. Competitive ELISA and receptor binding (96-well format) compared most favorably with mouse bioassay. Between-laboratory relative standard deviations (RSDR) ranged from 10 to 20% for ELISA and 14 to 31% for receptor binding. Within-laboratory (RSDr) ranged from 6 to 15% for ELISA, and 5 to 31% for receptor binding. Cell assay was extremely sensitive but data variation rendered it unsuitable for statistical treatment. LC/MS performed as well as ELISA on spiked test samples but was inordinately affected by lack of toxin-metabolite standards, uniform instrumental parameters, or both, on incurred test samples. The ELISA and receptor binding assay are good alternatives to mouse bioassay for the determination of brevetoxins in shellfish.

Predictive performance and inter-laboratory reproducibility in assessing eye irritation potential of water- and oil-soluble mixtures using the Short Time Exposure test method.

PubMed

Abo, Takayuki; Hilberer, Allison; Behle-Wagner, Christine; Watanabe, Mika; Cameron, David; Kirst, Annette; Nukada, Yuko; Yuki, Takuo; Araki, Daisuke; Sakaguchi, Hitoshi; Itagaki, Hiroshi

2018-04-01

The Short Time Exposure (STE) test method is an alternative method for assessing eye irritation potential using Statens Seruminstitut Rabbit Cornea cells and has been adopted as test guideline 491 by the Organisation for Economic Co-operation and Development. Its good predictive performance in identifying the Globally Harmonized System (GHS) No Category (NC) or Irritant Category has been demonstrated in evaluations of water-soluble substances, oil-soluble substances, and water-soluble mixtures. However, the predictive performance for oil-soluble mixtures was not evaluated. Twenty-four oil-soluble mixtures were evaluated using the STE test method. The GHS NC or Irritant Category of 22 oil-soluble mixtures were consistent with that of a Reconstructed human Cornea-like Epithelium (RhCE) test method. Inter-laboratory reproducibility was then confirmed using 20 water- and oil-soluble mixtures blind-coded. The concordance in GHS NC or Irritant Category among four laboratories was 90%-100%. In conclusion, the concordance in comparison with the results of RhCE test method using 24 oil-soluble mixtures and inter-laboratory reproducibility using 20 water- and oil-soluble mixtures blind-coded were good, indicating that the STE test method is a suitable alternative for predicting the eye irritation potential of both substances and mixtures. Copyright © 2018 Elsevier Ltd. All rights reserved.

Interlaboratory comparability, bias, and precision for four laboratories measuring constituents in precipitation, November 1982-August 1983

USGS Publications Warehouse

Brooks, M.H.; Schroder, L.J.; Malo, B.A.

1985-01-01

Four laboratories were evaluated in their analysis of identical natural and simulated precipitation water samples. Interlaboratory comparability was evaluated using analysis of variance coupled with Duncan 's multiple range test, and linear-regression models describing the relations between individual laboratory analytical results for natural precipitation samples. Results of the statistical analyses indicate that certain pairs of laboratories produce different results when analyzing identical samples. Analyte bias for each laboratory was examined using analysis of variance coupled with Duncan 's multiple range test on data produced by the laboratories from the analysis of identical simulated precipitation samples. Bias for a given analyte produced by a single laboratory has been indicated when the laboratory mean for that analyte is shown to be significantly different from the mean for the most-probable analyte concentrations in the simulated precipitation samples. Ion-chromatographic methods for the determination of chloride, nitrate, and sulfate have been compared with the colorimetric methods that were also in use during the study period. Comparisons were made using analysis of variance coupled with Duncan 's multiple range test for means produced by the two methods. Analyte precision for each laboratory has been estimated by calculating a pooled variance for each analyte. Analyte estimated precisions have been compared using F-tests and differences in analyte precisions for laboratory pairs have been reported. (USGS)

Laboratory-based versus non-laboratory-based method for assessment of cardiovascular disease risk: the NHANES I Follow-up Study cohort

PubMed Central

Gaziano, Thomas A; Young, Cynthia R; Fitzmaurice, Garrett; Atwood, Sidney; Gaziano, J Michael

2008-01-01

Summary Background Around 80% of all cardiovascular deaths occur in developing countries. Assessment of those patients at high risk is an important strategy for prevention. Since developing countries have limited resources for prevention strategies that require laboratory testing, we assessed if a risk prediction method that did not require any laboratory tests could be as accurate as one requiring laboratory information. Methods The National Health and Nutrition Examination Survey (NHANES) was a prospective cohort study of 14 407 US participants aged between 25–74 years at the time they were first examined (between 1971 and 1975). Our follow-up study population included participants with complete information on these surveys who did not report a history of cardiovascular disease (myocardial infarction, heart failure, stroke, angina) or cancer, yielding an analysis dataset N=6186. We compared how well either method could predict first-time fatal and non-fatal cardiovascular disease events in this cohort. For the laboratory-based model, which required blood testing, we used standard risk factors to assess risk of cardiovascular disease: age, systolic blood pressure, smoking status, total cholesterol, reported diabetes status, and current treatment for hypertension. For the non-laboratory-based model, we substituted body-mass index for cholesterol. Findings In the cohort of 6186, there were 1529 first-time cardiovascular events and 578 (38%) deaths due to cardiovascular disease over 21 years. In women, the laboratory-based model was useful for predicting events, with a c statistic of 0·829. The c statistic of the non-laboratory-based model was 0·831. In men, the results were similar (0·784 for the laboratory-based model and 0·783 for the non-laboratory-based model). Results were similar between the laboratory-based and non-laboratory-based models in both men and women when restricted to fatal events only. Interpretation A method that uses non-laboratory-based risk factors predicted cardiovascular events as accurately as one that relied on laboratory-based values. This approach could simplify risk assessment in situations where laboratory testing is inconvenient or unavailable. PMID:18342687

AFNOR validation of Premi Test, a microbiological-based screening tube-test for the detection of antimicrobial residues in animal muscle tissue.

PubMed

Gaudin, Valerie; Juhel-Gaugain, Murielle; Morétain, Jean-Pierre; Sanders, Pascal

2008-12-01

Premi Test contains viable spores of a strain of Bacillus stearothermophilus which is sensitive to antimicrobial residues, such as beta-lactams, tetracyclines, macrolides and sulphonamides. The growth of the strain is inhibited by the presence of antimicrobial residues in muscle tissue samples. Premi Test was validated according to AFNOR rules (French Association for Normalisation). The AFNOR validation was based on the comparison of reference methods (French Official method, i.e. four plate test (FPT) and the STAR protocol (five plate test)) with the alternative method (Premi Test). A preliminary study was conducted in an expert laboratory (Community Reference Laboratory, CRL) on both spiked and incurred samples (field samples). Several method performance criteria (sensitivity, specificity, relative accuracy) were estimated and are discussed, in addition to detection capabilities. Adequate agreement was found between the alternative method and the reference methods. However, Premi Test was more sensitive to beta-lactams and sulphonamides than the FPT. Subsequently, a collaborative study with 11 laboratories was organised by the CRL. Blank and spiked meat juice samples were sent to participants. The expert laboratory (CRL) statistically analysed the results. It was concluded that Premi Test could be used for the routine determination of antimicrobial residues in muscle of different animal origin with acceptable analytical performance. The detection capabilities of Premi Test for beta-lactams (amoxicillin, ceftiofur), one macrolide (tylosin) and tetracycline were at the level of the respective maximum residue limits (MRL) in muscle samples or even lower.

Laboratory and clinical evaluation of on-site urine drug testing.

PubMed

Beck, Olof; Carlsson, Sten; Tusic, Marinela; Olsson, Robert; Franzen, Lisa; Hulten, Peter

2014-11-01

Products for on-site urine drug testing offer the possibility to perform screening for drugs of abuse directly at the point-of-care. This is a well-established routine in emergency and dependency clinics but further evaluation of performance is needed due to inherent limitations with the available products. Urine drug testing by an on-site product was compared with routine laboratory methods. First, on-site testing was performed at the laboratory in addition to the routine method. Second, the on-site testing was performed at a dependency clinic and urine samples were subsequently sent to the laboratory for additional analytical investigation. The on-site testing products did not perform with assigned cut-off levels. The subjective reading between the presence of a spot (i.e. negative test result) being present or no spot (positive result) was difficult in 3.2% of the cases, and occurred for all parameters. The tests performed more accurately in drug negative samples (specificity 96%) but less accurately for detecting positives (sensitivity 79%). Of all incorrect results by the on-site test the proportion of false negatives was 42%. The overall agreement between on-site and laboratory testing was 95% in the laboratory study and 98% in the clinical study. Although a high degree of agreement was observed between on-site and routine laboratory urine drug testing, the performance of on-site testing was not acceptable due to significant number of false negative results. The limited sensitivity of on-site testing compared to laboratory testing reduces the applicability of these tests.

The Accutrend sensor glucose analyzer may not be adequate in bedside testing for neonatal hypoglycemia.

PubMed

Rosenthal, Mark; Ugele, Bernhard; Lipowsky, Gerd; Küster, Helmut

2006-02-01

The aim of this prospective observational study was to compare a bedside test with the reference laboratory method in routine postnatal glucose monitoring. Term newborns with increased risk or clinical signs of hypoglycemia were screened with a bedside test. In case of a glucose value below 2.25 mmol/L, a second blood sample was taken and a duplicate glucose measurement done in the laboratory using a bedside test (Accutrend sensor) and the reference laboratory method (hexokinase method) at the same time and from the same sample. From 110 term newborns, 122 blood samples were obtained for duplicate measurements (median 1.69 mmol/L, SD 0.45 mmol/L). Of these 122, Accutrend correctly identified 97% as being <2.25 mmol/L by the laboratory method. A Bland-Altman plot revealed a mean underestimation of the Accutrend of only -0.09 mmol/L. However, due to high scattering, the maximal over- and underestimation was 0.89 and 1.39 mmol/L, respectively. Only 75% of the results from the Accutrend were within +/-20% of the result of the laboratory method. If the cut-off for low glucose concentrations was set 0.6 mmol/L higher for the bedside test as compared to the laboratory method, all patients except one would have been correctly identified as hypoglycemic. When using the Accutrend sensor, single infants with even marked hypoglycemia might be missed. Some delay in receiving accurate measurements might be more helpful for clinical decisions and long-term outcome than immediate but potentially misleading results.

Combined ultraviolet and water exposure as a preconditioning method in laboratory fungal durability testing

Treesearch

Rebecca E. Ibach; Craig M. Clemons; Nicole M. Stark

2003-01-01

During outdoor exposure, woodfiber-plastic composites (WPC) are subject to biological, moisture, and ultraviolet (UV) degradation. The purpose of laboratory evaluations is to simulate outdoor conditions and accelerate the testing for quicker results. Traditionally, biological, moisture, and W laboratory tests are done separately, and only combined in outdoor field...

Comparison of basic laboratory test results with more sophisticated laboratory and in-situ tests methods on soils in southeastern Wisconsin : final report, March 21, 2009.

DOT National Transportation Integrated Search

2009-03-21

This study investigates all of the generated soils data in an attempt to use the more 'routine' laboratory tests to determine geotechnical design parameters (such as phiangle, cohesion, wet unit weight, unconfined compression, consolidation character...

10 CFR 431.18 - Testing laboratories.

Code of Federal Regulations, 2010 CFR

2010-01-01

... EQUIPMENT Electric Motors Test Procedures, Materials Incorporated and Methods of Determining Efficiency... Technology/National Voluntary Laboratory Accreditation Program (NIST/NVLAP); or (2) A laboratory... of the National Institute of Standards and Technology (NIST) which is part of the U.S. Department of...

Laboratory test methods for evaluating the fire response of aerospace materials

NASA Technical Reports Server (NTRS)

Hilado, C. J.

1979-01-01

The test methods which were developed or evaluated were intended to serve as means of comparing materials on the basis of specific responses under specific sets of test conditions, using apparatus, facilities, and personnel that would be within the capabilities of perhaps the majority of laboratories. Priority was given to test methods which showed promise of addressing the pre-ignition state of a potential fire. These test methods were intended to indicate which materials may present more hazard than others under specific test conditions. These test methods are discussed and arranged according to the stage of a fire to which they are most relevant. Some observations of material performance which resulted from this work are also discussed.

Results of the first provisional technical secretariat interlaboratory comparison test

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

Stuff, J.R.; Hoffland, L.

1995-06-01

The principal task of this laboratory in the first Provisional Technical Secretariat (PTS) Interlaboratory Comparison Test was to verify and test the extraction and preparation procedures outlined in the Recommended Operating Procedures for Sampling and Analysis in the Verification of Chemical Disarmament in addition to our laboratory extraction methods and our laboratory analysis methods. Sample preparation began on 16 May 1994 and analysis was completed on 12 June 1994. The analytical methods used included NMR ({sup 1}H and {sup 31}P) GC/AED, GC/MS (EI and methane CI), GC/IRD, HPLC/IC, HPLC/TSP/MS, MS/MS(Electrospray), and CZE.

Comparative evaluation of two quantitative test methods for determining the efficacy of liquid sporicides and sterilants on a hard surface: a precollaborative study.

PubMed

Tomasino, Stephen F; Hamilton, Martin A

2007-01-01

Two quantitative carrier-based test methods for determining the efficacy of liquid sporicides and sterilants on a hard surface, the Standard Quantitative Carrier Test Method-ASTM E 2111-00 and an adaptation of a quantitative micro-method as reported by Sagripanti and Bonifacino, were compared in this study. The methods were selected based on their desirable characteristics (e.g., well-developed protocol, previous use with spores, fully quantitative, and use of readily available equipment) for testing liquid sporicides and sterilants on a hard surface. In this paper, the Sagripanti-Bonifacino procedure is referred to as the Three Step Method (TSM). AOAC Official Method 966.04 was included in this study as a reference method. Three laboratories participated in the evaluation. Three chemical treatments were tested: (1) 3000 ppm sodium hypochlorite with pH adjusted to 7.0, (2) a hydrogen peroxide/peroxyacetic acid product, and (3) 3000 ppm sodium hypochlorite with pH unadjusted (pH of approximately 10.0). A fourth treatment, 6000 ppm sodium hypochlorite solution with pH adjusted to 7.0, was included only for Method 966.04 as a positive control (high level of efficacy). The contact time was 10 min for all chemical treatments except the 6000 ppm sodium hypochlorite treatment which was tested at 30 min. Each chemical treatment was tested 3 times using each of the methods. Only 2 of the laboratories performed the AOAC method. Method performance was assessed by the within-laboratory variance, between-laboratory variance, and total variance associated with the log reduction (LR) estimates generated by each quantitative method. The quantitative methods performed similarly, and the LR values generated by each method were not statistically different for the 3 treatments evaluated. Based on feedback from the participating laboratories, compared to the TSM, ASTM E 2111-00 was more resource demanding and required more set-up time. The logistical and resource concerns identified for ASTM E 2111-00 were largely associated with the filtration process and counting bacterial colonies on filters. Thus, the TSM was determined to be the most suitable method.

Laboratory test for ice adhesion strength using commercial instrumentation.

PubMed

Wang, Chenyu; Zhang, Wei; Siva, Adarsh; Tiea, Daniel; Wynne, Kenneth J

2014-01-21

A laboratory test method for evaluating ice adhesion has been developed employing a commercially available instrument normally used for dynamic mechanical analysis (TA RSA-III). This is the first laboratory ice adhesion test that does not require a custom-built apparatus. The upper grip range of ∼10 mm is an enabling feature that is essential for the test. The method involves removal of an ice cylinder from a polymer coating with a probe and the determination of peak removal force (Ps). To validate the test method, the strength of ice adhesion was determined for a prototypical glassy polymer, poly(methyl methacrylate). The distance of the probe from the PMMA surface has been identified as a critical variable for Ps. The new test provides a readily available platform for investigating fundamental surface characteristics affecting ice adhesion. In addition to the ice release test, PMMA coatings were characterized using DSC, DCA, and TM-AFM.

Validation of a Laboratory Method for Evaluating Dynamic Properties of Reconstructed Equine Racetrack Surfaces

PubMed Central

Setterbo, Jacob J.; Chau, Anh; Fyhrie, Patricia B.; Hubbard, Mont; Upadhyaya, Shrini K.; Symons, Jennifer E.; Stover, Susan M.

2012-01-01

Background Racetrack surface is a risk factor for racehorse injuries and fatalities. Current research indicates that race surface mechanical properties may be influenced by material composition, moisture content, temperature, and maintenance. Race surface mechanical testing in a controlled laboratory setting would allow for objective evaluation of dynamic properties of surface and factors that affect surface behavior. Objective To develop a method for reconstruction of race surfaces in the laboratory and validate the method by comparison with racetrack measurements of dynamic surface properties. Methods Track-testing device (TTD) impact tests were conducted to simulate equine hoof impact on dirt and synthetic race surfaces; tests were performed both in situ (racetrack) and using laboratory reconstructions of harvested surface materials. Clegg Hammer in situ measurements were used to guide surface reconstruction in the laboratory. Dynamic surface properties were compared between in situ and laboratory settings. Relationships between racetrack TTD and Clegg Hammer measurements were analyzed using stepwise multiple linear regression. Results Most dynamic surface property setting differences (racetrack-laboratory) were small relative to surface material type differences (dirt-synthetic). Clegg Hammer measurements were more strongly correlated with TTD measurements on the synthetic surface than the dirt surface. On the dirt surface, Clegg Hammer decelerations were negatively correlated with TTD forces. Conclusions Laboratory reconstruction of racetrack surfaces guided by Clegg Hammer measurements yielded TTD impact measurements similar to in situ values. The negative correlation between TTD and Clegg Hammer measurements confirms the importance of instrument mass when drawing conclusions from testing results. Lighter impact devices may be less appropriate for assessing dynamic surface properties compared to testing equipment designed to simulate hoof impact (TTD). Potential Relevance Dynamic impact properties of race surfaces can be evaluated in a laboratory setting, allowing for further study of factors affecting surface behavior under controlled conditions. PMID:23227183

Audit of Helicobacter pylori Testing in Microbiology Laboratories in England: To Inform Compliance with NICE Guidance and the Feasibility of Routine Antimicrobial Resistance Surveillance

PubMed Central

Allison, Rosalie; Lecky, Donna M.; Bull, Megan; Turner, Kim; Godbole, Gauri

2016-01-01

Introduction. The National Institute for Health and Clinical Excellence (NICE) guidance recommends that dyspeptic patients are tested for Helicobacter pylori using a urea breath test, stool antigen test, or serology. Antibiotic resistance in H. pylori is globally increasing, but treatment in England is rarely guided by susceptibility testing or surveillance. Aims. To determine compliance of microbiology laboratories in England with NICE guidance and whether laboratories perform culture and antibiotic susceptibility testing (AST). Methods. In 2015, 170 accredited English microbiology laboratories were surveyed, by email. Results. 121/170 (71%) laboratories responded; 96% provided H. pylori testing (78% on site). 94% provided H. pylori diagnosis using stool antigen; only four provided serology as their noninvasive test; 3/4 of these encouraged urea breath tests in their acute trusts. Only 22/94 (23%) of the laboratories performed H. pylori cultures from gastric biopsies on site; 9/22 performed AST, but the vast majority processed less than one specimen/week. Conclusions. Only five laboratories in England do not comply with NICE guidance; these will need the guidance reinforced. National surveillance needs to be implemented; culture-based AST would need to be centralised. Moving forward, detection of resistance in H. pylori from stool specimens using molecular methods (PCR) needs to be explored. PMID:27829836

A SIMPLE METHOD FOR EVALUATING DATA FROM AN INTERLABORATORY STUDY

EPA Science Inventory

Large-scale laboratory-and method-performance studies involving more than about 30 laboratories may be evaluated by calculating the HORRAT ratio for each test sample (HORRAT=[experimentally found among-laboratories relative standard deviation] divided by [relative standard deviat...

Cosmetics Europe multi-laboratory pre-validation of the SkinEthic™ reconstituted human corneal epithelium test method for the prediction of eye irritation.

PubMed

Alépée, N; Bessou-Touya, S; Cotovio, J; de Smedt, A; de Wever, B; Faller, C; Jones, P; Le Varlet, B; Marrec-Fairley, M; Pfannenbecker, U; Tailhardat, M; van Goethem, F; McNamee, P

2013-08-01

Cosmetics Europe, The Personal Care Association, known as Colipa before 2012, conducted a program of technology transfer and assessment of Within/Between Laboratory (WLV/BLV) reproducibility of the SkinEthic™ Reconstituted Human Corneal Epithelium (HCE) as one of two human reconstructed tissue eye irritation test methods. The SkinEthic™ HCE test method involves two exposure time treatment procedures - one for short time exposure (10 min - SE) and the other for long time exposure (60 min - LE) of tissues to test substance. This paper describes pre-validation studies of the SkinEthic™ HCE test method (SE and LE protocols) as well as the Eye Peptide Reactivity Assay (EPRA). In the SE WLV study, 30 substances were evaluated. A consistent outcome with respect to viability measurement across all runs was observed with all substances showing an SD of less than 18%. In the LE WLV study, 44 out of 45 substances were consistently classified. These data demonstrated a high level of reproducibility within laboratory for both the SE and LE treatment procedures. For the LE BLV, 19 out of 20 substances were consistently classified between the three laboratories, again demonstrating a high level of reproducibility between laboratories. The results for EPRA WLV and BLV studies demonstrated that all substances analysed were categorised similarly and that the method is reproducible. The SkinEthic™ HCE test method entered into the experimental phase of a formal ECVAM validation program in 2010. Copyright © 2013. Published by Elsevier Ltd.

Interlaboratory evaluation of Hyalella azteca and Chironomus tentans short-term and long-term sediment toxicity tests

USGS Publications Warehouse

Norberg-King, T. J.; Sibley, P.K.; Burton, G.A.; Ingersoll, C.G.; Kemble, N.E.; Ireland, S.; Mount, D.R.; Rowland, C.D.

2006-01-01

Methods for assessing the long-term toxicity of sediments to Hyalella azteca and Chironomus tentans can significantly enhance the capacity to assess sublethal effects of contaminated sediments through multiple endpoints. Sublethal tests allow us to begin to understand the relationship between short-term and long-term effects for toxic sediments. We present an interlaboratory evaluation with long-term and 10-d tests using control and contaminated sediments in which we assess whether proposed and existing performance criteria (test acceptability criteria [TAC]) could be achieved. Laboratories became familiar with newly developed, long-term protocols by testing two control sediments in phase 1. In phase 2, the 10-d and long-term tests were examined with several sediments. Laboratories met the TACs, but results varied depending on the test organism, test duration, and endpoints. For the long-term tests in phase 1, 66 to 100% of the laboratories consistently met the TACs for survival, growth, or reproduction using H. azteca, and 70 to 100% of the laboratories met the TACs for survival and growth, emergence, reproduction, and hatchability using C. tentans. In phase 2, fewer laboratories participated in long-term tests: 71 to 88% of the laboratories met the TAC for H. azteca, whereas 50 to 67% met the TAC for C. tentans. In the 10-d tests with H. azteca, and C. tentans, 82 and 88% of the laboratories met the TAC for survival, respectively, and 80% met the TAC for C. tentans growth. For the 10-d and long-term tests, laboratories predicted similar toxicity. Overall, the interlaboratory evaluation showed good precision of the methods, appropriate endpoints were incorporated into the test protocols, and tests effectively predicted the toxicity of sediments.

A novel method to remotely measure food intake of free-living individuals in real time: the remote food photography method.

PubMed

Martin, Corby K; Han, Hongmei; Coulon, Sandra M; Allen, H Raymond; Champagne, Catherine M; Anton, Stephen D

2009-02-01

The aim of the present study was to report the first reliability and validity tests of the remote food photography method (RFPM), which consists of camera-enabled cell phones with data transfer capability. Participants take and transmit photographs of food selection and plate waste to researchers/clinicians for analysis. Following two pilot studies, adult participants (n 52; BMI 20-35 kg/m2 inclusive) were randomly assigned to the dine-in or take-out group. Energy intake (EI) was measured for 3 d. The dine-in group ate lunch and dinner in the laboratory. The take-out group ate lunch in the laboratory and dinner in free-living conditions (participants received a cooler with pre-weighed food that they returned the following morning). EI was measured with the RFPM and by directly weighing foods. The RFPM was tested in laboratory and free-living conditions. Reliability was tested over 3 d and validity was tested by comparing directly weighed EI to EI estimated with the RFPM using Bland-Altman analysis. The RFPM produced reliable EI estimates over 3 d in laboratory (r 0.62; P < 0.0001) and free-living (r 0.68; P < 0.0001) conditions. Weighed EI correlated highly with EI estimated with the RFPM in laboratory and free-living conditions (r>0.93; P < 0.0001). In two laboratory-based validity tests, the RFPM underestimated EI by - 4.7 % (P = 0.046) and - 5.5 % (P = 0.076). In free-living conditions, the RFPM underestimated EI by - 6.6 % (P = 0.017). Bias did not differ by body weight or age. The RFPM is a promising new method for accurately measuring the EI of free-living individuals. Error associated with the method is small compared with self-report methods.

Antianaerobic Antimicrobials: Spectrum and Susceptibility Testing

PubMed Central

Wexler, Hannah M.; Goldstein, Ellie J. C.

2013-01-01

SUMMARY Susceptibility testing of anaerobic bacteria recovered from selected cases can influence the choice of antimicrobial therapy. The Clinical and Laboratory Standards Institute (CLSI) has standardized many laboratory procedures, including anaerobic susceptibility testing (AST), and has published documents for AST. The standardization of testing methods by the CLSI allows comparisons of resistance trends among various laboratories. Susceptibility testing should be performed on organisms recovered from sterile body sites, those that are isolated in pure culture, or those that are clinically important and have variable or unique susceptibility patterns. Organisms that should be considered for individual isolate testing include highly virulent pathogens for which susceptibility cannot be predicted, such as Bacteroides, Prevotella, Fusobacterium, and Clostridium spp.; Bilophila wadsworthia; and Sutterella wadsworthensis. This review describes the current methods for AST in research and reference laboratories. These methods include the use of agar dilution, broth microdilution, Etest, and the spiral gradient endpoint system. The antimicrobials potentially effective against anaerobic bacteria include beta-lactams, combinations of beta-lactams and beta-lactamase inhibitors, metronidazole, chloramphenicol, clindamycin, macrolides, tetracyclines, and fluoroquinolones. The spectrum of efficacy, antimicrobial resistance mechanisms, and resistance patterns against these agents are described. PMID:23824372

PubMed Central

Petithory, J. C.; Ambroise-Thomas, P.; De Loye, J.; Pelloux, H.; Goullier-Fleuret, A.; Milgram, M.; Buffard, C.; Garin, J. P.

1996-01-01

Reported are the results of a multicentre study involving 40 laboratories that was carried out in France to assess all the currently available methods used for the serodiagnosis of toxoplasmosis. For this purpose 10 batches of control sera were prepared with titres in the range 0-260 IU per ml. These sera were tested in nine laboratories using immunofluorescence methods; in three laboratories using dye tests; in forty laboratories using enzyme-linked immunosorbent assay; in four laboratories using direct agglutination and haemagglutination; in seven laboratories using the high-sensitivity IgG agglutination test; and in three laboratories using the latex agglutination test. In this way, 70 series of titrations were carried out using seven procedures and the results were compared with those obtained using the WHO reference serum in 15 cases, with the French national E6 serum in 16 other cases, and in 39 cases using 15 reference sera supplied by the reagent manufacturers. Rigorous comparison of the tests was not possible in all cases because one aim of the study was to ensure that the tests were carried out under the usual working conditions that prevailed in the participating laboratories. The results obtained indicate that the serological tests currently available for toxoplasmosis are acceptable for its serodiagnosis. Presentation of the titres in IU has advantages; however, caution is required since the definition of IU varies according to the test and reagents used. It is therefore essential that the conditions and limits for a positive reaction be carefully defined in each case, especially for commercially available kits. PMID:8829878

Good Laboratory Practices of Materials Testing at NASA White Sands Test Facility

NASA Technical Reports Server (NTRS)

Hirsch, David; Williams, James H.

2005-01-01

An approach to good laboratory practices of materials testing at NASA White Sands Test Facility is presented. The contents include: 1) Current approach; 2) Data analysis; and 3) Improvements sought by WSTF to enhance the diagnostic capability of existing methods.

Antinuclear antibody determination in a routine laboratory.

PubMed Central

Feltkamp, T E

1996-01-01

Pitfalls in the method for demonstrating antinuclear antibodies (ANA) by the indirect immunofluorescence technique are described and the use of international standard preparations outlined. Determination of the optimal border dilution dividing positive from negative results is discussed. Each laboratory is a unique setting; it must define its own method, which should rarely be changed. One should not rely on copying methods from other laboratories or commercial firms, but the reproducibility of the nuclear substrate, the conjugate, and other variables should be controlled daily by the use of a control serum which has been related to the WHO standard preparation for ANA of the homogeneous type. Since many sera contain mixtures of different ANA, the results of routine tests are best expressed in titres or expressions of the intensity of fluorescence. The ANA test using the immunofluorescence technique should be used as a screening method for other tests allowing a more defined interpretation of the ANA. Each laboratory should individually determine the border between positive and negative results. Therefore about 200 sera from local healthy controls equally distributed over sex and age, and 100 sera from local patients with definite SLE should be tested. Since the local clinicians should become acquainted with this border it should rarely be changed. Finally each laboratory should participate regularly in national and international quality control rounds, where sera known to be difficult to interpret are tested. The judgment of the organisers of these rounds should stimulate improvements in the participating laboratories. PMID:8984936

Accounting for differing exposure patterns between laboratory tests and the field in the assessment of long-term risks of pesticides to terrestrial vertebrates.

PubMed

Fischer, David L

2005-11-01

Long-term risks of pesticides to birds and mammals are currently assessed by comparing effects thresholds determined in chronic laboratory studies to exposure levels expected to occur in the field. However, there is often a mismatch between exposure patterns tested in the laboratory tests (exposure levels held constant) and those experienced by animals in the field (exposure levels varying over time). Three methods for addressing this problem are presented and discussed. Time-weighted averaging (TWA) converts a variable field exposure regime to a single value that can be compared directly to the laboratory test results. Body-burden modeling (BBM) is applied to both laboratory and field exposure regimes allowing a straightforward comparison of body residue levels expected for each situation. Temporal analysis (TA) uses expert judgment to decide if the length of time exposure exceeds a toxicity threshold is long enough to cause biologically significant effects. To reduce uncertainty in long-term assessments, the conduct of specialized laboratory tests in which test subjects are administered a time-varying exposure that mimics what occurs in the field should be considered. Such tests may also be useful testing the validity of each of these assessment methods.

Round robin investigation of methods for the recovery of poliovirus from drinking water.

PubMed Central

Melnick, J L; Safferman, R; Rao, V C; Goyal, S; Berg, G; Dahling, D R; Wright, B A; Akin, E; Stetler, R; Sorber, C

1984-01-01

Six laboratories actively involved in water virology research participated in a methods evaluation study, conducted under the auspices of the American Society for Testing and Materials Committee on Viruses in the Aquatic Environment, Task Force on Drinking Water. Each participant was asked to examine the Viradel (virus adsorption-elution) method with cartridge-type Filterite filters for virus adsorption and organic flocculation and aluminum hydroxide-hydroextraction for reconcentration. Virus was adsorbed to filter media at pH 3.5 and eluted with either glycine buffer (pH 10.5) or beef extract-glycine (pHG 9.0). Considerable variation was noted in the quantity of virus recovered from four 100-liter samples of dechlorinated tapwater seeded with low (350 to 860 PFU) and high (1,837 to 4,689 PFU) doses of poliovirus type 1. To have a more uniform standard of comparison, all the test samples were reassayed in one laboratory, where titers were also determined for the virus seed. Test results of the Viradel-organic flocculation method indicated that the average percentage of virus recovery for low-input experiments was 66%, with a range of 8 to 20% in two laboratories, 49 to 63% in three laboratories, and 198% in one laboratory. For the high-input experiments, two laboratories reported recoveries of 6 to 12%, and four laboratories reported recoveries of 26 to 46%. For the Viradel aluminum hydroxide-hydroextraction procedure, two laboratories recovered 9 to 11%, whereas four obtained 17 to 34% for low-input experiments. For the high-input tests, two laboratories reported a recovery of 3 to 5%, and four recovered 11 to 18% of the seeded virus.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:6320720

Antimicrobial Testing Methods & Procedures Developed by EPA's Microbiology Laboratory

EPA Pesticide Factsheets

We develop antimicrobial testing methods and standard operating procedures to measure the effectiveness of hard surface disinfectants against a variety of microorganisms. Find methods and procedures for antimicrobial testing.

49 CFR 40.185 - Through what methods and to whom must a laboratory report split specimen results?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 1 2011-10-01 2011-10-01 false Through what methods and to whom must a laboratory report split specimen results? 40.185 Section 40.185 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Split Specimen Tests § 40.185 Through what methods and to whom...

Towards an evaluation framework for Laboratory Information Systems.

PubMed

Yusof, Maryati M; Arifin, Azila

Laboratory testing and reporting are error-prone and redundant due to repeated, unnecessary requests and delayed or missed reactions to laboratory reports. Occurring errors may negatively affect the patient treatment process and clinical decision making. Evaluation on laboratory testing and Laboratory Information System (LIS) may explain the root cause to improve the testing process and enhance LIS in supporting the process. This paper discusses a new evaluation framework for LIS that encompasses the laboratory testing cycle and the socio-technical part of LIS. Literature review on discourses, dimensions and evaluation methods of laboratory testing and LIS. A critical appraisal of the Total Testing Process (TTP) and the human, organization, technology-fit factors (HOT-fit) evaluation frameworks was undertaken in order to identify error incident, its contributing factors and preventive action pertinent to laboratory testing process and LIS. A new evaluation framework for LIS using a comprehensive and socio-technical approach is outlined. Positive relationship between laboratory and clinical staff resulted in a smooth laboratory testing process, reduced errors and increased process efficiency whilst effective use of LIS streamlined the testing processes. The TTP-LIS framework could serve as an assessment as well as a problem-solving tool for the laboratory testing process and system. Copyright © 2016 King Saud Bin Abdulaziz University for Health Sciences. Published by Elsevier Ltd. All rights reserved.

[How to Interpret and Use Routine Laboratory Data--Our Methods to Interpret Routine Laboratory Data--Chairmen's Introductory Remarks].

PubMed

Honda, Takayuki; Tozuka, Minoru

2015-09-01

In the reversed clinicopathological conference (R-CPC), three specialists in laboratory medicine interpreted routine laboratory data independently in order to understand the detailed state of a patient. R-CPC is an educational method to use laboratory data appropriately, and it is also important to select differential diagnoses in a process of clinical reasoning in addition to the present illness and physical examination. Routine laboratory tests can be performed repeatedly at a relatively low cost, and their time-series analysis can be performed. Interpretation of routine laboratory data is almost the same as taking physical findings. General findings are initially checked and then the state of each organ is examined. Although routine laboratory tests cost little, we can gain much more information from them about the patient than physical examinations.

Current status of accreditation for drug testing in hair.

PubMed

Cooper, Gail; Moeller, Manfred; Kronstrand, Robert

2008-03-21

At the annual meeting of the Society of Hair Testing in Vadstena, Sweden in 2006, a committee was appointed to address the issue of guidelines for hair testing and to assess the current status of accreditation amongst laboratories offering drug testing in hair. A short questionnaire was circulated amongst the membership and interested parties. Fifty-two responses were received from hair testing laboratories providing details on the amount and type of hair tests they offered and the status of accreditation within their facilities. Although the vast majority of laboratories follow current guidelines (83%), only nine laboratories were accredited to ISO/IEC 17025 for hair testing. A significant number of laboratories reporting that they were in the process of developing quality systems with a view to accrediting their methods within 2-3 years. This study provides an insight into the status of accreditation in hair testing laboratories and supports the need for guidelines to encourage best practice.

9 CFR 590.580 - Laboratory tests and analyses.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Laboratory tests and analyses. 590.580 Section 590.580 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... sequence, frequency, and approved laboratory methods as prescribed by the AMS Science Division Director...

9 CFR 590.580 - Laboratory tests and analyses.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Laboratory tests and analyses. 590.580 Section 590.580 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... sequence, frequency, and approved laboratory methods as prescribed by the AMS Science Division Director...

9 CFR 590.580 - Laboratory tests and analyses.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Laboratory tests and analyses. 590.580 Section 590.580 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... sequence, frequency, and approved laboratory methods as prescribed by the AMS Science Division Director...

International Council for Standardization in Haematology (ICSH) Recommendations for Laboratory Measurement of Direct Oral Anticoagulants.

PubMed

Gosselin, Robert C; Adcock, Dorothy M; Bates, Shannon M; Douxfils, Jonathan; Favaloro, Emmanuel J; Gouin-Thibault, Isabelle; Guillermo, Cecilia; Kawai, Yohko; Lindhoff-Last, Edelgard; Kitchen, Steve

2018-03-01

This guidance document was prepared on behalf of the International Council for Standardization in Haematology (ICSH) for providing haemostasis-related guidance documents for clinical laboratories. This inaugural coagulation ICSH document was developed by an ad hoc committee, comprised of international clinical and laboratory direct acting oral anticoagulant (DOAC) experts. The committee developed consensus recommendations for laboratory measurement of DOACs (dabigatran, rivaroxaban, apixaban and edoxaban), which would be germane for laboratories assessing DOAC anticoagulation. This guidance document addresses all phases of laboratory DOAC measurements, including pre-analytical (e.g. preferred time sample collection, preferred sample type, sample stability), analytical (gold standard method, screening and quantifying methods) and post analytical (e.g. reporting units, quality assurance). The committee addressed the use and limitations of screening tests such as prothrombin time, activated partial thromboplastin time as well as viscoelastic measurements of clotting blood and point of care methods. Additionally, the committee provided recommendations for the proper validation or verification of performance of laboratory assays prior to implementation for clinical use, and external quality assurance to provide continuous assessment of testing and reporting method. Schattauer GmbH Stuttgart.

[Interlaboratory Study on Evaporation Residue Test for Food Contact Products (Report 1)].

PubMed

Ohno, Hiroyuki; Mutsuga, Motoh; Abe, Tomoyuki; Abe, Yutaka; Amano, Homare; Ishihara, Kinuyo; Ohsaka, Ikue; Ohno, Haruka; Ohno, Yuichiro; Ozaki, Asako; Kakihara, Yoshiteru; Kobayashi, Hisashi; Sakuragi, Hiroshi; Shibata, Hiroshi; Shirono, Katsuhiro; Sekido, Haruko; Takasaka, Noriko; Takenaka, Yu; Tajima, Yoshiyasu; Tanaka, Aoi; Tanaka, Hideyuki; Tonooka, Hiroyuki; Nakanishi, Toru; Nomura, Chie; Haneishi, Nahoko; Hayakawa, Masato; Miura, Toshihiko; Yamaguchi, Miku; Watanabe, Kazunari; Sato, Kyoko

2018-01-01

An interlaboratory study was performed to evaluate the equivalence between an official method and a modified method of evaporation residue test using three food-simulating solvents (water, 4% acetic acid and 20% ethanol), based on the Japanese Food Sanitation Law for food contact products. Twenty-three laboratories participated, and tested the evaporation residues of nine test solutions as blind duplicates. For evaporation, a water bath was used in the official method, and a hot plate in the modified method. In most laboratories, the test solutions were heated until just prior to evaporation to dryness, and then allowed to dry under residual heat. Statistical analysis revealed that there was no significant difference between the two methods, regardless of the heating equipment used. Accordingly, the modified method provides performance equal to the official method, and is available as an alternative method.

Challenges of measles and rubella laboratory diagnostic in the era of elimination.

PubMed

Hübschen, J M; Bork, S M; Brown, K E; Mankertz, A; Santibanez, S; Ben Mamou, M; Mulders, M N; Muller, C P

2017-08-01

The Member States of the WHO European Region adopted the goal of measles and rubella elimination more than 10 years ago, but so far only 21 of 53 countries have reached this target. Laboratory investigation of suspected cases is essential to support disease elimination efforts. Therefore, WHO maintains a network of accredited laboratories providing high-quality testing. Laboratory investigation heavily relies on specific IgM serology and increasingly on virus detection by reverse transcription (RT)-PCR, but other methods such as IgG avidity testing and genetic characterization of virus strains have gained in importance. In elimination settings, often few samples from suspected cases are available for testing, but testing proficiency must be maintained. The predictive value of an IgM-positive result decreases and other rash-fever disease aetiologies become more important. In addition, cases with a rash after measles/rubella vaccination or with mild disease after waning of vaccine-induced antibodies are seen more often. Thus, it is necessary to perform comprehensive and potentially time-consuming and costly investigations of every suspected case using quality-controlled laboratory methods. At the same time rapid feedback to public health officers is required for timely interventions. The introduction of new laboratory methods for comprehensive case investigations requires training of staff under the supervision of WHO-accredited reference laboratories and the definition of appropriate test algorithms. Clinical, laboratory, and epidemiological data are essential for final case classification and investigation of chains of transmission in the endgame of measles and rubella elimination. Copyright © 2017 European Society of Clinical Microbiology and Infectious Diseases. All rights reserved.

Inter-laboratory Comparison of Three Earplug Fit-test Systems

PubMed Central

Byrne, David C.; Murphy, William J.; Krieg, Edward F.; Ghent, Robert M.; Michael, Kevin L.; Stefanson, Earl W.; Ahroon, William A.

2017-01-01

The National Institute for Occupational Safety and Health (NIOSH) sponsored tests of three earplug fit-test systems (NIOSH HPD Well-Fit™, Michael & Associates FitCheck, and Honeywell Safety Products VeriPRO®). Each system was compared to laboratory-based real-ear attenuation at threshold (REAT) measurements in a sound field according to ANSI/ASA S12.6-2008 at the NIOSH, Honeywell Safety Products, and Michael & Associates testing laboratories. An identical study was conducted independently at the U.S. Army Aeromedical Research Laboratory (USAARL), which provided their data for inclusion in this report. The Howard Leight Airsoft premolded earplug was tested with twenty subjects at each of the four participating laboratories. The occluded fit of the earplug was maintained during testing with a soundfield-based laboratory REAT system as well as all three headphone-based fit-test systems. The Michael & Associates lab had highest average A-weighted attenuations and smallest standard deviations. The NIOSH lab had the lowest average attenuations and the largest standard deviations. Differences in octave-band attenuations between each fit-test system and the American National Standards Institute (ANSI) sound field method were calculated (Attenfit-test - AttenANSI). A-weighted attenuations measured with FitCheck and HPD Well-Fit systems demonstrated approximately ±2 dB agreement with the ANSI sound field method, but A-weighted attenuations measured with the VeriPRO system underestimated the ANSI laboratory attenuations. For each of the fit-test systems, the average A-weighted attenuation across the four laboratories was not significantly greater than the average of the ANSI sound field method. Standard deviations for residual attenuation differences were about ±2 dB for FitCheck and HPD Well-Fit compared to ±4 dB for VeriPRO. Individual labs exhibited a range of agreement from less than a dB to as much as 9.4 dB difference with ANSI and REAT estimates. Factors such as the experience of study participants and test administrators, and the fit-test psychometric tasks are suggested as possible contributors to the observed results. PMID:27786602

19 CFR 151.73 - Importer's request for commercial laboratory test.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Hair § 151.73 Importer's request for commercial laboratory test. (a) Conditions for commercial test. If... request that a commercial test be made to determine the percentage clean yield of the wool or hair. (b... the wool or hair in dispute to be selected and tested by a commercial method approved by the...

19 CFR 151.73 - Importer's request for commercial laboratory test.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Hair § 151.73 Importer's request for commercial laboratory test. (a) Conditions for commercial test. If... request that a commercial test be made to determine the percentage clean yield of the wool or hair. (b... the wool or hair in dispute to be selected and tested by a commercial method approved by the...

19 CFR 151.73 - Importer's request for commercial laboratory test.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Hair § 151.73 Importer's request for commercial laboratory test. (a) Conditions for commercial test. If... request that a commercial test be made to determine the percentage clean yield of the wool or hair. (b... the wool or hair in dispute to be selected and tested by a commercial method approved by the...

19 CFR 151.73 - Importer's request for commercial laboratory test.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Hair § 151.73 Importer's request for commercial laboratory test. (a) Conditions for commercial test. If... request that a commercial test be made to determine the percentage clean yield of the wool or hair. (b... the wool or hair in dispute to be selected and tested by a commercial method approved by the...

19 CFR 151.73 - Importer's request for commercial laboratory test.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Hair § 151.73 Importer's request for commercial laboratory test. (a) Conditions for commercial test. If... request that a commercial test be made to determine the percentage clean yield of the wool or hair. (b... the wool or hair in dispute to be selected and tested by a commercial method approved by the...

Phosphorus blood test

MedlinePlus

... eds. Laboratory Tests and Diagnostic Procedures . 6th ed. St Louis, MO: Elsevier Saunders; 2013:878-880. Klemm ... Diagnosis and Management by Laboratory Methods . 23rd ed. St Louis, MO: Elsevier; 2017:chap 15. Kliegman RM, ...

Extracting laboratory test information from biomedical text

PubMed Central

Kang, Yanna Shen; Kayaalp, Mehmet

2013-01-01

Background: No previous study reported the efficacy of current natural language processing (NLP) methods for extracting laboratory test information from narrative documents. This study investigates the pathology informatics question of how accurately such information can be extracted from text with the current tools and techniques, especially machine learning and symbolic NLP methods. The study data came from a text corpus maintained by the U.S. Food and Drug Administration, containing a rich set of information on laboratory tests and test devices. Methods: The authors developed a symbolic information extraction (SIE) system to extract device and test specific information about four types of laboratory test entities: Specimens, analytes, units of measures and detection limits. They compared the performance of SIE and three prominent machine learning based NLP systems, LingPipe, GATE and BANNER, each implementing a distinct supervised machine learning method, hidden Markov models, support vector machines and conditional random fields, respectively. Results: Machine learning systems recognized laboratory test entities with moderately high recall, but low precision rates. Their recall rates were relatively higher when the number of distinct entity values (e.g., the spectrum of specimens) was very limited or when lexical morphology of the entity was distinctive (as in units of measures), yet SIE outperformed them with statistically significant margins on extracting specimen, analyte and detection limit information in both precision and F-measure. Its high recall performance was statistically significant on analyte information extraction. Conclusions: Despite its shortcomings against machine learning methods, a well-tailored symbolic system may better discern relevancy among a pile of information of the same type and may outperform a machine learning system by tapping into lexically non-local contextual information such as the document structure. PMID:24083058

Research and test facilities

NASA Technical Reports Server (NTRS)

1993-01-01

A description is given of each of the following Langley research and test facilities: 0.3-Meter Transonic Cryogenic Tunnel, 7-by 10-Foot High Speed Tunnel, 8-Foot Transonic Pressure Tunnel, 13-Inch Magnetic Suspension & Balance System, 14-by 22-Foot Subsonic Tunnel, 16-Foot Transonic Tunnel, 16-by 24-Inch Water Tunnel, 20-Foot Vertical Spin Tunnel, 30-by 60-Foot Wind Tunnel, Advanced Civil Transport Simulator (ACTS), Advanced Technology Research Laboratory, Aerospace Controls Research Laboratory (ACRL), Aerothermal Loads Complex, Aircraft Landing Dynamics Facility (ALDF), Avionics Integration Research Laboratory, Basic Aerodynamics Research Tunnel (BART), Compact Range Test Facility, Differential Maneuvering Simulator (DMS), Enhanced/Synthetic Vision & Spatial Displays Laboratory, Experimental Test Range (ETR) Flight Research Facility, General Aviation Simulator (GAS), High Intensity Radiated Fields Facility, Human Engineering Methods Laboratory, Hypersonic Facilities Complex, Impact Dynamics Research Facility, Jet Noise Laboratory & Anechoic Jet Facility, Light Alloy Laboratory, Low Frequency Antenna Test Facility, Low Turbulence Pressure Tunnel, Mechanics of Metals Laboratory, National Transonic Facility (NTF), NDE Research Laboratory, Polymers & Composites Laboratory, Pyrotechnic Test Facility, Quiet Flow Facility, Robotics Facilities, Scientific Visualization System, Scramjet Test Complex, Space Materials Research Laboratory, Space Simulation & Environmental Test Complex, Structural Dynamics Research Laboratory, Structural Dynamics Test Beds, Structures & Materials Research Laboratory, Supersonic Low Disturbance Pilot Tunnel, Thermal Acoustic Fatigue Apparatus (TAFA), Transonic Dynamics Tunnel (TDT), Transport Systems Research Vehicle, Unitary Plan Wind Tunnel, and the Visual Motion Simulator (VMS).

Toxicity and bioaccumulation of sediment-associated contaminants using freshwater invertebrates: A review of methods and applications

USGS Publications Warehouse

Ingersoll, C.G.; Ankley, G.T.; Benoit, D.A.; Brunson, E.L.; Burton, G.A.; Dwyer, F.J.; Hoke, R.A.; Landrum, P.F.; Norberg-King, T. J.; Winger, P.V.

1995-01-01

This paper reviews recent developments in methods for evaluating the toxicity and bioaccumulation of contaminants associated with freshwater sediments and summarizes example case studies demonstrating the application of these methods. Over the past decade, research has emphasized development of more specific testing procedures for conducting 10-d toxicity tests with the amphipod Hyalella azteca and the midge Chironomus tentans. Toxicity endpoints measured in these tests are survival for H. azteca and survival and growth for C. tentans. Guidance has also been developed for conducting 28-d bioaccumulation tests with the oligochaete Lumbriculus variegatus, including determination of bioaccumulation kinetics for different compound classes. These methods have been applied to a variety of sediments to address issues ranging from site assessments to bioavailability of organic and inorganic contaminants using field-collected and laboratory-spiked samples. Survival and growth of controls routinely meet or exceed test acceptability criteria. Results of laboratory bioaccumulation studies with L. variegatus have been confirmed with comparisons to residues (PCBs, PAHs, DDT) present from synoptically collected field populations of oligochaetes. Additional method development is currently underway to develop chronic toxicity tests and to provide additional data-confirming responses observed in laboratory sediment tests with natural benthic populations.

A Reference Method for Measuring Emissions of SVOCs in ...

EPA Pesticide Factsheets

Semivolatile organic compounds (SVOCs) are indoor air pollutants that may may have significant adverse effects on human health, and emission of SVOCs from building materials and consumer products is of growing concern. Few chamber studies have been conducted due to the challenges associated with SVOC analysis and the lack of validation procedures. Thus there is an urgent need for a reliable and accurate chamber test method to verify the performance of these measurements. A reference method employing a specially-designed chamber and experimental protocol has been developed and is undergoing extensive evaluation. A pilot interlaboratory study (ILS) has been conducted with five laboratories performing chamber tests under identical conditions. Results showed inter-laboratory variations at 25% for SVOC emission rates, with greater agreement observed between intra-laboratory measurements for most of the participating laboratories. The measured concentration profiles also compared reasonably well to the mechanistic model, demonstrating the feasibility of the proposed reference method to independently assess laboratory performance and validate SVOC emission tests. There is an urgent need for improved understanding of the measurement uncertainties associated with SVOC emissions testing. The creation of specially-designed chambers and well-characterized materials serves as a critical prerequisite for improving the procedure used to measure SVOCs emitted from indoor

A novel method to remotely measure food intake of free-living people in real-time

PubMed Central

Martin, Corby K.; Han, Hongmei; Coulon, Sandra M.; Allen, H. Raymond; Champagne, Catherine M.; Anton, Stephen D.

2008-01-01

The aim of this study was to report the first reliability and validity tests of the Remote Food Photography Method (RFPM), which consists of camera-enabled cell phones with data transfer capability. Participants take and transmit photographs of food selection and plate waste to researchers/clinicians for analysis. Following two pilot studies, adult participants (N=52, 20≤BMI≤35) were randomly assigned to the dine-in or take-out group. Energy intake (EI) was measured for three days. The dine-in group ate lunch and dinner in the laboratory. The take-out group ate lunch in the laboratory and dinner in free-living conditions (participants received a cooler with pre-weighed food that they returned the following morning). Energy intake was measured with the RFPM and by directly weighing foods. The RFPM was tested in laboratory and free-living conditions. Reliability was tested over three days and validity was tested by comparing directly weighed EI to EI estimated with the RFPM using Bland-Altman analysis. The RFPM produced reliable EI estimates over three days in laboratory (r=.62, p<.0001) and free-living (r=.68, p<.0001) conditions. Weighed EI correlated highly with EI estimated with the RFPM in laboratory and free-living conditions (r’s>.93, p<.0001). In two laboratory-based validity tests, the RFPM underestimated EI by -4.7% (p=.046) and -5.5% (p=.076). In free-living conditions, the RFPM underestimated EI by -6.6% (p=.017). Bias did not differ by body weight or age. The RFPM is a promising new method for accurately measuring the EI of free-living people. Error associated with the method is small compared to self-report methods. PMID:18616837

Antidiuretic hormone blood test

MedlinePlus

... eds. Laboratory Tests and Diagnostic Procedures . 6th ed. St Louis, MO: Elsevier Saunders; 2013:146. Guber HA, ... Diagnosis and Management by Laboratory Methods . 23rd ed. St Louis, MO: Elsevier; 2017:chap 24. Oh MS, ...

Creating and Evaluating a Hypertext System of Documenting Analytical Test Methods in a Chemical Plant Quality Assurance Laboratory.

ERIC Educational Resources Information Center

White, Charles E., Jr.

The purpose of this study was to develop and implement a hypertext documentation system in an industrial laboratory and to evaluate its usefulness by participative observation and a questionnaire. Existing word-processing test method documentation was converted directly into a hypertext format or "hyperdocument." The hyperdocument was designed and…

Integrated Data Collection Analysis (IDCA) Program - RDX Type II Class 5 Standard, Data Set 1

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

Sandstrom, Mary M.; Brown, Geoffrey W.; Preston, Daniel N.

This document describes the results of the first reference sample material—RDX Type II Class 5—examined in the proficiency study for small-scale safety and thermal (SSST) testing of explosive materials for the Integrated Data Collection Analysis (IDCA) Program. The IDCA program is conducting proficiency testing on homemade explosives (HMEs). The reference sample materials are being studied to establish the accuracy of traditional explosives safety testing for each performing laboratory. These results will be used for comparison to results from testing HMEs. This effort, funded by the Department of Homeland Security (DHS), ultimately will put the issues of safe handling of thesemore » materials in perspective with standard military explosives. The results of the study will add SSST testing results for a broad suite of different HMEs to the literature, potentially suggest new guidelines and methods for HME testing, and possibly establish what are the needed accuracies in SSST testing to develop safe handling practices. Described here are the results for impact, friction, electrostatic discharge, and scanning calorimetry analysis of a reference sample of RDX Type II Class 5. The results from each participating testing laboratory are compared using identical test material and preparation methods wherever possible. Note, however, the test procedures differ among the laboratories. These results are then compared to historical data from various sources. The performers involved are Lawrence Livermore National Laboratory (LLNL), Los Alamos National Laboratory (LANL), Air Force Research Laboratory/ RXQL (AFRL), Indian Head Division, Naval Surface Warfare Center, (IHD-NSWC), and Sandia National Laboratories (SNL). These tests are conducted as a proficiency study in order to establish some consistency in test protocols, procedures, and experiments and to understand how to compare results when test protocols are not identical.« less

Hydrogen Field Test Standard: Laboratory and Field Performance

PubMed Central

Pope, Jodie G.; Wright, John D.

2015-01-01

The National Institute of Standards and Technology (NIST) developed a prototype field test standard (FTS) that incorporates three test methods that could be used by state weights and measures inspectors to periodically verify the accuracy of retail hydrogen dispensers, much as gasoline dispensers are tested today. The three field test methods are: 1) gravimetric, 2) Pressure, Volume, Temperature (PVT), and 3) master meter. The FTS was tested in NIST's Transient Flow Facility with helium gas and in the field at a hydrogen dispenser location. All three methods agree within 0.57 % and 1.53 % for all test drafts of helium gas in the laboratory setting and of hydrogen gas in the field, respectively. The time required to perform six test drafts is similar for all three methods, ranging from 6 h for the gravimetric and master meter methods to 8 h for the PVT method. The laboratory tests show that 1) it is critical to wait for thermal equilibrium to achieve density measurements in the FTS that meet the desired uncertainty requirements for the PVT and master meter methods; in general, we found a wait time of 20 minutes introduces errors < 0.1 % and < 0.04 % in the PVT and master meter methods, respectively and 2) buoyancy corrections are important for the lowest uncertainty gravimetric measurements. The field tests show that sensor drift can become a largest component of uncertainty that is not present in the laboratory setting. The scale was calibrated after it was set up at the field location. Checks of the calibration throughout testing showed drift of 0.031 %. Calibration of the master meter and the pressure sensors prior to travel to the field location and upon return showed significant drifts in their calibrations; 0.14 % and up to 1.7 %, respectively. This highlights the need for better sensor selection and/or more robust sensor testing prior to putting into field service. All three test methods are capable of being successfully performed in the field and give equivalent answers if proper sensors without drift are used. PMID:26722192

Comparative evaluation of subgrade resilient modulus from non-destructive, in-situ, and laboratory methods.

DOT National Transportation Integrated Search

2007-08-01

Field and laboratory testing programs were conducted to develop models that predict the resilient modulus of subgrade soils from : the test results of DCP, CIMCPT, FWD, Dynaflect, and soil properties. The field testing program included DCP, CIMCPT, F...

[Quality Management and Quality Specifications of Laboratory Tests in Clinical Studies--Challenges in Pre-Analytical Processes in Clinical Laboratories].

PubMed

Ishibashi, Midori

2015-01-01

The cost, speed, and quality are the three important factors recently indicated by the Ministry of Health, Labour and Welfare (MHLW) for the purpose of accelerating clinical studies. Based on this background, the importance of laboratory tests is increasing, especially in the evaluation of clinical study participants' entry and safety, and drug efficacy. To assure the quality of laboratory tests, providing high-quality laboratory tests is mandatory. For providing adequate quality assurance in laboratory tests, quality control in the three fields of pre-analytical, analytical, and post-analytical processes is extremely important. There are, however, no detailed written requirements concerning specimen collection, handling, preparation, storage, and shipping. Most laboratory tests for clinical studies are performed onsite in a local laboratory; however, a part of laboratory tests is done in offsite central laboratories after specimen shipping. As factors affecting laboratory tests, individual and inter-individual variations are well-known. Besides these factors, standardizing the factors of specimen collection, handling, preparation, storage, and shipping, may improve and maintain the high quality of clinical studies in general. Furthermore, the analytical method, units, and reference interval are also important factors. It is concluded that, to overcome the problems derived from pre-analytical processes, it is necessary to standardize specimen handling in a broad sense.

Gasoline and Diesel Fuel Test Methods Additional Resources

EPA Pesticide Factsheets

Supporting documents on the Direct Final Rule that allows refiners and laboratories to use more current and improved fuel testing procedures for twelve American Society for Testing and Materials analytical test methods.

78 FR 20695 - Walk-Through Metal Detectors and Hand-Held Metal Detectors Test Method Validation

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-05

... Detectors and Hand-Held Metal Detectors Test Method Validation AGENCY: National Institute of Justice, DOJ... ensure that the test methods in the standards are properly documented, NIJ is requesting proposals (including price quotes) for test method validation efforts from testing laboratories. NIJ is also seeking...

Modeling Canadian Quality Control Test Program for Steroid Hormone Receptors in Breast Cancer: Diagnostic Accuracy Study.

PubMed

Pérez, Teresa; Makrestsov, Nikita; Garatt, John; Torlakovic, Emina; Gilks, C Blake; Mallett, Susan

The Canadian Immunohistochemistry Quality Control program monitors clinical laboratory performance for estrogen receptor and progesterone receptor tests used in breast cancer treatment management in Canada. Current methods assess sensitivity and specificity at each time point, compared with a reference standard. We investigate alternative performance analysis methods to enhance the quality assessment. We used 3 methods of analysis: meta-analysis of sensitivity and specificity of each laboratory across all time points; sensitivity and specificity at each time point for each laboratory; and fitting models for repeated measurements to examine differences between laboratories adjusted by test and time point. Results show 88 laboratories participated in quality control at up to 13 time points using typically 37 to 54 histology samples. In meta-analysis across all time points no laboratories have sensitivity or specificity below 80%. Current methods, presenting sensitivity and specificity separately for each run, result in wide 95% confidence intervals, typically spanning 15% to 30%. Models of a single diagnostic outcome demonstrated that 82% to 100% of laboratories had no difference to reference standard for estrogen receptor and 75% to 100% for progesterone receptor, with the exception of 1 progesterone receptor run. Laboratories with significant differences to reference standard identified with Generalized Estimating Equation modeling also have reduced performance by meta-analysis across all time points. The Canadian Immunohistochemistry Quality Control program has a good design, and with this modeling approach has sufficient precision to measure performance at each time point and allow laboratories with a significantly lower performance to be targeted for advice.

Culturing Stool Specimens for Campylobacter spp., Pennsylvania, USA

PubMed Central

M’ikanatha, Nkuchia M.; Dettinger, Lisa A.; Perry, Amanda; Rogers, Paul; Reynolds, Stanley M.

2012-01-01

In 2010, we surveyed 176 clinical laboratories in Pennsylvania regarding stool specimen testing practices for enteropathogens, including Campylobacter spp. Most (96.3%) routinely test for Campylobacter spp. In 17 (15.7%), a stool antigen test is the sole method for diagnosis. We recommend that laboratory practice guidelines for Campylobacter spp. testing be developed. PMID:22377086

Residue analysis of tetracyclines in poultry muscle: shortcomings revealed by a proficiency test.

PubMed

Berendsen, B J A; Van Rhijn, J A

2006-11-01

A proficiency test for tetracycline drug residues in poultry muscle was organized according to the guidelines of International Laboratory Accreditation Cooperation (ILAC) ILAC-G13:2000 (2000). For the proficiency test, three test materials were prepared. The homogeneity and stability of the materials during the study were demonstrated. Sixteen laboratories accepted the invitation to participate in the proficiency test; 11 laboratories reported results within the time frame of the study. Most notably, only four of the participating laboratories complied with the definition of the maximum residue limit (MRL) concerning the inclusion of 4-epimers as stated in European Commission Regulation 281/96 (1996). Most participants reported values for the decision limit (CCalpha) and detection capability (CCbeta) and hence were already in compliance with European Commission 2002/657/EC (2002) for this aspect of method validation. However, some CCalpha and CCbeta values were not in agreement with the actual within-laboratory reproducibility calculated from the results reported in this proficiency test. Although most laboratories obtained satisfactory results, it is clear that an effort is needed to include 4-epiOTC, 4-epiTC and 4-epiCTC in the analytical methods. Moreover, reconsideration of values determined for CCalpha and CCbeta with respect to their accuracy may be necessary in some cases.

46 CFR 63.25-9 - Incinerators.

Code of Federal Regulations, 2010 CFR

2010-10-01

... inspections and tests required by this section; (3) Have documentary proof of the laboratory's qualifications... methods and standards for testing emissions. The methods and standards for testing emissions that the...

Using Benchmarking To Strengthen the Assessment of Persistence.

PubMed

McLachlan, Michael S; Zou, Hongyan; Gouin, Todd

2017-01-03

Chemical persistence is a key property for assessing chemical risk and chemical hazard. Current methods for evaluating persistence are based on laboratory tests. The relationship between the laboratory based estimates and persistence in the environment is often unclear, in which case the current methods for evaluating persistence can be questioned. Chemical benchmarking opens new possibilities to measure persistence in the field. In this paper we explore how the benchmarking approach can be applied in both the laboratory and the field to deepen our understanding of chemical persistence in the environment and create a firmer scientific basis for laboratory to field extrapolation of persistence test results.

Testing of the Defense Waste Processing Facility Cold Chemical Dissolution Method in Sludge Batch 9 Qualification

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

Edwards, T.; Pareizs, J.; Coleman, C.

For each sludge batch that is processed in the Defense Waste Processing Facility (DWPF), the Savannah River National Laboratory (SRNL) tests the applicability of the digestion methods used by the DWPF Laboratory for elemental analysis of Sludge Receipt and Adjustment Tank (SRAT) Receipt samples and SRAT Product process control samples. DWPF SRAT samples are typically dissolved using a method referred to as the DWPF Cold Chemical or Cold Chem Method (CC), (see DWPF Procedure SW4- 15.201). Testing indicates that the CC method produced mixed results. The CC method did not result in complete dissolution of either the SRAT Receipt ormore » SRAT Product with some fine, dark solids remaining. However, elemental analyses did not reveal extreme biases for the major elements in the sludge when compared with analyses obtained following dissolution by hot aqua regia (AR) or sodium peroxide fusion (PF) methods. The CC elemental analyses agreed with the AR and PF methods well enough that it should be adequate for routine process control analyses in the DWPF after much more extensive side-by-side tests of the CC method and the PF method are performed on the first 10 SRAT cycles of the Sludge Batch 9 (SB9) campaign. The DWPF Laboratory should continue with their plans for further tests of the CC method during these 10 SRAT cycles.« less

Leaching Test Relationships, Laboratory-to-Field Comparisons and Recommendations for Leaching Evaluation using the Leaching Environmental Assessment Framework (LEAF)

EPA Science Inventory

This report presents examples of the relationships between the results of laboratory leaching tests, as defined by the Leaching Environmental Assessment Framework (LEAF) or analogous international test methods, and leaching of constituents from a broad range of materials under di...

Quality control ranges for testing broth microdilution susceptibility of Flavobacterium columnare and F. psychrophilium to nine antimicrobials

USDA-ARS?s Scientific Manuscript database

A multi-laboratory broth microdilution method trial was performed to standardize the specialized test conditions required for fish pathogens Flavobacterium columnare and F. pyschrophilum. Nine laboratories tested the quality control (QC) strains Escherichia coli ATCC 25922 and Aeromonas salmonicid...

Determination of Glucosamine in Raw Materials and Dietary Supplements Containing Glucosamine Sulfate and/or Glucosamine Hydrochloride by High-Performance Liquid Chromatography with FMOC-Su Derivatization: Collaborative Study

PubMed Central

Zhou, Joseph Ziqi; Waszkuc, Ted; Mohammed, Felicia

2008-01-01

A collaborative study was conducted for determination of glucosamine in raw materials and dietary supplements containing glucosamine sulfate and/or glucosamine hydrochloride by high-performance liquid Chromatography (HPLC) with N-(9-fluorenyl-methoxycarbonyloxy) succinimide (FMOC-Su) derivatization. Thirteen blind materials, one pair of which were duplicates, were tested by 12 collaborating laboratories. The test samples consisted of various commercial products, including tablets, capsules, drink mix, and liquids as well as raw materials, blanks, and those for spike recovery analyses. The tests with blank products and products spiked with glucosamine showed good specificity of the method. The average recoveries at spike levels of 100 and 150% of the declared amount were 99.0% with a relative standard deviation (RSD) of 2.1%, and 101% with an RSD of 2.3%, respectively. The test results between laboratories on each commercial product were reproducible with RSD values of no more than 4.0%, and the results were repeatable in the same laboratory with an average RSD of 0.7%. HorRat values ranged from 0.5 to 1.7 on both tests of spike recovery and reproducibility between laboratories on commercial products. The average determination coefficient of the calibration curves from the laboratories was 0.9995 with an RSD of 0.03%. All of the 12 collaborating laboratories succeeded in the study and none of their reported test results were outliers, partly indicating the robustness of the method. It is recommended that the method be accepted by AOAC INTERNATIONAL as Official First Action. PMID:16152919

The breaking load method - Results and statistical modification from the ASTM interlaboratory test program

NASA Technical Reports Server (NTRS)

Colvin, E. L.; Emptage, M. R.

1992-01-01

The breaking load test provides quantitative stress corrosion cracking data by determining the residual strength of tension specimens that have been exposed to corrosive environments. Eight laboratories have participated in a cooperative test program under the auspices of ASTM Committee G-1 to evaluate the new test method. All eight laboratories were able to distinguish between three tempers of aluminum alloy 7075. The statistical analysis procedures that were used in the test program do not work well in all situations. An alternative procedure using Box-Cox transformations shows a great deal of promise. An ASTM standard method has been drafted which incorporates the Box-Cox procedure.

Integrated Data Collection Analysis (IDCA) Program - Final Review September 12, 2012 at DHS

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

Sandstrom, Mary M.; Brown, Geoffrey W.; Warner, Kirstin F.

The Integrated Data Collection Analysis (IDCA) program conducted a final program review at the Department of Homeland Security on September 12, 2012. The review was focused on the results of the program over the complete performance period. A summary presentation delineating the accomplished tasks started the meeting, followed by technical presentations on various issues that arose during the performance period. The presentations were completed with a statistical evaluation of the testing results from all the participants in the IDCA Proficiency Test study. The meeting closed with a discussion of potential sources of funding for continuing work to resolve some ofmore » these technical issues. This effort, funded by the Department of Homeland Security (DHS), put the issues of safe handling of these materials in perspective with standard military explosives. The study added Small-Scale Safety and Thermal (SSST) testing results for a broad suite of different HMEs to the literature, and suggested new guidelines and methods to develop safe handling practices for HMEs. Each participating testing laboratory used identical test materials and preparation methods wherever possible. Note, however, the test procedures differ among the laboratories. The results were compared among the laboratories and then compared to historical data from various sources. The testing performers involved were Lawrence Livermore National Laboratory (LLNL), Los Alamos National Laboratory (LANL), Naval Surface Warfare Center, Indian Head Division (NSWC IHD), Sandia National Laboratories (SNL), and Air Force Research Laboratory, Tyndall AFB (AFRL/RXQL). These tests were conducted as a proficiency study in order to establish some consistency in test protocols, procedures, and experiments and to compare results when these testing variables cannot be made consistent.« less

76 FR 5319 - Regulation of Fuel and Fuel Additives: Alternative Test Method for Olefins in Gasoline

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-31

... Regulation of Fuel and Fuel Additives: Alternative Test Method for Olefins in Gasoline AGENCY: Environmental... proposing to allow refiners and laboratories to use an alternative test method for olefin content in... test method for compliance measurement while maintaining environmental benefits achieved from our fuels...

Developing a laboratory protocol for asphalt binder recovery.

DOT National Transportation Integrated Search

2014-10-01

Asphalt binder extraction and recovery are common laboratory procedures used to provide material for research and quality : assurance testing. The most common methods of recovery performed today include the Abson method and the rotary evaporator : (o...

Practical Aspects of Designing and Conducting Validation Studies Involving Multi-study Trials.

PubMed

Coecke, Sandra; Bernasconi, Camilla; Bowe, Gerard; Bostroem, Ann-Charlotte; Burton, Julien; Cole, Thomas; Fortaner, Salvador; Gouliarmou, Varvara; Gray, Andrew; Griesinger, Claudius; Louhimies, Susanna; Gyves, Emilio Mendoza-de; Joossens, Elisabeth; Prinz, Maurits-Jan; Milcamps, Anne; Parissis, Nicholaos; Wilk-Zasadna, Iwona; Barroso, João; Desprez, Bertrand; Langezaal, Ingrid; Liska, Roman; Morath, Siegfried; Reina, Vittorio; Zorzoli, Chiara; Zuang, Valérie

This chapter focuses on practical aspects of conducting prospective in vitro validation studies, and in particular, by laboratories that are members of the European Union Network of Laboratories for the Validation of Alternative Methods (EU-NETVAL) that is coordinated by the EU Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM). Prospective validation studies involving EU-NETVAL, comprising a multi-study trial involving several laboratories or "test facilities", typically consist of two main steps: (1) the design of the validation study by EURL ECVAM and (2) the execution of the multi-study trial by a number of qualified laboratories within EU-NETVAL, coordinated and supported by EURL ECVAM. The approach adopted in the conduct of these validation studies adheres to the principles described in the OECD Guidance Document on the Validation and International Acceptance of new or updated test methods for Hazard Assessment No. 34 (OECD 2005). The context and scope of conducting prospective in vitro validation studies is dealt with in Chap. 4 . Here we focus mainly on the processes followed to carry out a prospective validation of in vitro methods involving different laboratories with the ultimate aim of generating a dataset that can support a decision in relation to the possible development of an international test guideline (e.g. by the OECD) or the establishment of performance standards.

Catch-up validation study of an in vitro skin irritation test method based on an open source reconstructed epidermis (phase II).

PubMed

Groeber, F; Schober, L; Schmid, F F; Traube, A; Kolbus-Hernandez, S; Daton, K; Hoffmann, S; Petersohn, D; Schäfer-Korting, M; Walles, H; Mewes, K R

2016-10-01

To replace the Draize skin irritation assay (OECD guideline 404) several test methods based on reconstructed human epidermis (RHE) have been developed and were adopted in the OECD test guideline 439. However, all validated test methods in the guideline are linked to RHE provided by only three companies. Thus, the availability of these test models is dependent on the commercial interest of the producer. To overcome this limitation and thus to increase the accessibility of in vitro skin irritation testing, an open source reconstructed epidermis (OS-REp) was introduced. To demonstrate the capacity of the OS-REp in regulatory risk assessment, a catch-up validation study was performed. The participating laboratories used in-house generated OS-REp to assess the set of 20 reference substances according to the performance standards amending the OECD test guideline 439. Testing was performed under blinded conditions. The within-laboratory reproducibility of 87% and the inter-laboratory reproducibility of 85% prove a high reliability of irritancy testing using the OS-REp protocol. In addition, the prediction capacity was with an accuracy of 80% comparable to previous published RHE based test protocols. Taken together the results indicate that the OS-REp test method can be used as a standalone alternative skin irritation test replacing the OECD test guideline 404. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Forest Herbicide Washoff From Foliar Applications

Treesearch

J.L. Michael; Kevin L. Talley; H.C. Fishburn

1992-01-01

Field and laboratory experiments were conducted to develop and test methods for determining washoff of foliar applied herbicides typically used in forestry in the South.Preliminary results show good agreement between results of laboratory methods used and observations from field experiments on actual precipitation events. Methods included application of...

TEST METHODS TO DETERMINE THE MERCURY EMISSIONS FROM SLUDGE INCINERATION PLANTS

EPA Science Inventory

Two test methods for mercury are described along with the laboratory and field studies done in developing and validating them. One method describes how to homogenize and analyze large quantities of sewage sludge. The other test method describes how to measure the mercury emission...

2000-hour cyclic endurance test of a laboratory model multipropellant resistojet

NASA Technical Reports Server (NTRS)

Morren, W. Earl; Sovey, James S.

1987-01-01

The technological readiness of a long-life multipropellant resistojet for space station auxiliary propulsion is demonstrated. A laboratory model resistojet made from grain-stabilized platinum served as a test bed to evaluate the design characteristics, fabrication methods, and operating strategies for an engineering model multipropellant resistojet developed under contract by the Rocketdyne Division of Rockwell International and Technion Incorporated. The laboratory model thruster was subjected to a 2000-hr, 2400-thermal-cycle endurance test using carbon dioxide propellant. Maximum thruster temperatures were approximately 1400 C. The post-test analyses of the laboratory model thruster included an investigation of component microstructures. Significant observations from the laboratory model thruster are discussed as they relate to the design of the engineering model thruster.

A 2000-hour cyclic endurance test of a laboratory model multipropellant resistojet

NASA Technical Reports Server (NTRS)

Morren, W. Earl; Sovey, James S.

1987-01-01

The technological readiness of a long-life multipropellant resistojet for space station auxiliary propulsion is demonstrated. A laboratory model resistojet made from grain-stabilized platinum served as a test bed to evaluate the design characteristics, fabrication methods, and operating strategies for an engineering model multipropellant resistojet developed under contract by the Rocketdyne Division of Rockwell International and Technion Incorporated. The laboratory model thruster was subjected to a 2000-hr, 2400-thermal-cycle endurance test using carbon dioxide propellant. Maximum thruster temperatures were approximately 1400 C. The post-test analyses of the laboratory model thruster included an investigation of component microstructures. Significant observations from the laboratory model thruster are discussed as they relate to the design of the engineering model thruster.

Creating Best Practices for the Submission of Actionable Food and Feed Testing Data Generated in State and Local Laboratories.

PubMed

Wangsness, Kathryn; Salfinger, Yvonne; Randolph, Robyn; Shea, Shari; Larson, Kirsten

2017-07-01

Laboratory accreditation provides a level of standardization in laboratories and confidence in generated food and feed testing results. For some laboratories, ISO/IEC 17025:2005 accreditation may not be fiscally viable, or a requested test method may be out of the scope of the laboratory's accreditation. To assist laboratories for whom accreditation is not feasible, the Association of Public Health Laboratories Data Acceptance Work Group developed a white paper entitled "Best Practices for Submission of Actionable Food and Feed Testing Data Generated in State and Local Laboratories." The basic elements of a quality management system, along with other best practices that state and local food and feed testing laboratories should follow, are included in the white paper. It also covers program-specific requirements that may need to be addressed. Communication with programs and end data users is regarded as essential for establishing the reliability and accuracy of laboratory data. Following these suggested best practices can facilitate the acceptance of laboratory data, which can result in swift regulatory action and the quick removal of contaminated product from the food supply, improving public health nationally.

Environmental Chemistry Methods (ECM) Index - Q

EPA Pesticide Factsheets

Laboratories use testing methods to identify pesticides in water and soil. Environmental chemistry methods test soil and water samples to determine the fate of pesticides in the environment. Find methods for chemicals with Q as the first character.

Environmental Chemistry Methods (ECM) Index - D

EPA Pesticide Factsheets

Laboratories use testing methods to identify pesticides in water and soil. Environmental chemistry methods test soil and water samples to determine the fate of pesticides in the environment. Find methods for chemicals with D as the first character.

Environmental Chemistry Methods (ECM) Index - N

EPA Pesticide Factsheets

Laboratories use testing methods to identify pesticides in water and soil. Environmental chemistry methods test soil and water samples to determine the fate of pesticides in the environment. Find methods for chemicals with N as the first character.

Environmental Chemistry Methods (ECM) Index - P

EPA Pesticide Factsheets

Laboratories use testing methods to identify pesticides in water and soil. Environmental chemistry methods test soil and water samples to determine the fate of pesticides in the environment. Find methods for chemicals with P as the first character.

Environmental Chemistry Methods (ECM) Index - L

EPA Pesticide Factsheets

Laboratories use testing methods to identify pesticides in water and soil. Environmental chemistry methods test soil and water samples to determine the fate of pesticides in the environment. Find methods for chemicals with L as the first character.

Environmental Chemistry Methods (ECM) Index - T

EPA Pesticide Factsheets

Laboratories use testing methods to identify pesticides in water and soil. Environmental chemistry methods test soil and water samples to determine the fate of pesticides in the environment. Find methods for chemicals with T as the first character.

Environmental Chemistry Methods (ECM) Index - A

EPA Pesticide Factsheets

Laboratories use testing methods to identify pesticides in water and soil. Environmental chemistry methods test soil and water samples to determine the fate of pesticides in the environment. Find methods for chemicals with A as the first character.

Environmental Chemistry Methods (ECM) Index - E

EPA Pesticide Factsheets

Laboratories use testing methods to identify pesticides in water and soil. Environmental chemistry methods test soil and water samples to determine the fate of pesticides in the environment. Find methods for chemicals with E as the first character.

Environmental Chemistry Methods (ECM) Index - O

EPA Pesticide Factsheets

Laboratories use testing methods to identify pesticides in water and soil. Environmental chemistry methods test soil and water samples to determine the fate of pesticides in the environment. Find methods for chemicals with O as the first character.

Environmental Chemistry Methods (ECM) Index - Z

EPA Pesticide Factsheets

Laboratories use testing methods to identify pesticides in water and soil. Environmental chemistry methods test soil and water samples to determine the fate of pesticides in the environment. Find methods for chemicals with Z as the first character.

Environmental Chemistry Methods (ECM) Index - I

EPA Pesticide Factsheets

Laboratories use testing methods to identify pesticides in water and soil. Environmental chemistry methods test soil and water samples to determine the fate of pesticides in the environment. Find methods for chemicals with I as the first character.

Environmental Chemistry Methods (ECM) Index - S

EPA Pesticide Factsheets

Laboratories use testing methods to identify pesticides in water and soil. Environmental chemistry methods test soil and water samples to determine the fate of pesticides in the environment. Find methods for chemicals with S as the first character.

Environmental Chemistry Methods (ECM) Index - K

EPA Pesticide Factsheets

Laboratories use testing methods to identify pesticides in water and soil. Environmental chemistry methods test soil and water samples to determine the fate of pesticides in the environment. Find methods for chemicals with K as the first character.

Environmental Chemistry Methods (ECM) Index - R

EPA Pesticide Factsheets

Laboratories use testing methods to identify pesticides in water and soil. Environmental chemistry methods test soil and water samples to determine the fate of pesticides in the environment. Find methods for chemicals with R as the first character.

Environmental Chemistry Methods (ECM) Index - G

EPA Pesticide Factsheets

Laboratories use testing methods to identify pesticides in water and soil. Environmental chemistry methods test soil and water samples to determine the fate of pesticides in the environment. Find methods for chemicals with G as the first character.

Environmental Chemistry Methods (ECM) Index - F

EPA Pesticide Factsheets

Laboratories use testing methods to identify pesticides in water and soil. Environmental chemistry methods test soil and water samples to determine the fate of pesticides in the environment. Find methods for chemicals with F as the first character.

Environmental Chemistry Methods (ECM) Index - B

EPA Pesticide Factsheets

Laboratories use testing methods to identify pesticides in water and soil. Environmental chemistry methods test soil and water samples to determine the fate of pesticides in the environment. Find methods for chemicals with B as the first character.

Environmental Chemistry Methods (ECM) Index - M

EPA Pesticide Factsheets

Laboratories use testing methods to identify pesticides in water and soil. Environmental chemistry methods test soil and water samples to determine the fate of pesticides in the environment. Find methods for chemicals with M as the first character.

Environmental Chemistry Methods (ECM) Index - C

EPA Pesticide Factsheets

Laboratories use testing methods to identify pesticides in water and soil. Environmental chemistry methods test soil and water samples to determine the fate of pesticides in the environment. Find methods for chemicals with C as the first character.

Environmental Chemistry Methods (ECM) Index - H

EPA Pesticide Factsheets

Laboratories use testing methods to identify pesticides in water and soil. Environmental chemistry methods test soil and water samples to determine the fate of pesticides in the environment. Find methods for chemicals with H as the first character.

Application of laboratory fungal resistance tests to solid wood and wood-plastic composite

Treesearch

Craig Merrill Clemons; Rebecca E. Ibach

2003-01-01

The fungal resistance of high density polyethylene filled with 50% wood flour was investigated using laboratory soil block tests. Modifications to standard test methods were made to increase initial moisture content, increase exposure surface area, and track moisture content, mechanical properties, and weight loss over the exposure period. Mechanical properties...

40 CFR 136.6 - Method modifications and analytical requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

... PROGRAMS (CONTINUED) GUIDELINES ESTABLISHING TEST PROCEDURES FOR THE ANALYSIS OF POLLUTANTS § 136.6 Method... person or laboratory using a test procedure (analytical method) in this part. (2) Chemistry of the method means the reagents and reactions used in a test procedure that allow determination of the analyte(s) of...

40 CFR 136.6 - Method modifications and analytical requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... PROGRAMS (CONTINUED) GUIDELINES ESTABLISHING TEST PROCEDURES FOR THE ANALYSIS OF POLLUTANTS § 136.6 Method... person or laboratory using a test procedure (analytical method) in this Part. (2) Chemistry of the method means the reagents and reactions used in a test procedure that allow determination of the analyte(s) of...

40 CFR 136.6 - Method modifications and analytical requirements.

Code of Federal Regulations, 2012 CFR

2012-07-01

... PROGRAMS (CONTINUED) GUIDELINES ESTABLISHING TEST PROCEDURES FOR THE ANALYSIS OF POLLUTANTS § 136.6 Method... person or laboratory using a test procedure (analytical method) in this part. (2) Chemistry of the method means the reagents and reactions used in a test procedure that allow determination of the analyte(s) of...

40 CFR 136.6 - Method modifications and analytical requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

... PROGRAMS (CONTINUED) GUIDELINES ESTABLISHING TEST PROCEDURES FOR THE ANALYSIS OF POLLUTANTS § 136.6 Method... person or laboratory using a test procedure (analytical method) in this part. (2) Chemistry of the method means the reagents and reactions used in a test procedure that allow determination of the analyte(s) of...

Appraisal of within- and between-laboratory reproducibility of non-radioisotopic local lymph node assay using flow cytometry, LLNA:BrdU-FCM: comparison of OECD TG429 performance standard and statistical evaluation.

PubMed

Yang, Hyeri; Na, Jihye; Jang, Won-Hee; Jung, Mi-Sook; Jeon, Jun-Young; Heo, Yong; Yeo, Kyung-Wook; Jo, Ji-Hoon; Lim, Kyung-Min; Bae, SeungJin

2015-05-05

Mouse local lymph node assay (LLNA, OECD TG429) is an alternative test replacing conventional guinea pig tests (OECD TG406) for the skin sensitization test but the use of a radioisotopic agent, (3)H-thymidine, deters its active dissemination. New non-radioisotopic LLNA, LLNA:BrdU-FCM employs a non-radioisotopic analog, 5-bromo-2'-deoxyuridine (BrdU) and flow cytometry. For an analogous method, OECD TG429 performance standard (PS) advises that two reference compounds be tested repeatedly and ECt(threshold) values obtained must fall within acceptable ranges to prove within- and between-laboratory reproducibility. However, this criteria is somewhat arbitrary and sample size of ECt is less than 5, raising concerns about insufficient reliability. Here, we explored various statistical methods to evaluate the reproducibility of LLNA:BrdU-FCM with stimulation index (SI), the raw data for ECt calculation, produced from 3 laboratories. Descriptive statistics along with graphical representation of SI was presented. For inferential statistics, parametric and non-parametric methods were applied to test the reproducibility of SI of a concurrent positive control and the robustness of results were investigated. Descriptive statistics and graphical representation of SI alone could illustrate the within- and between-laboratory reproducibility. Inferential statistics employing parametric and nonparametric methods drew similar conclusion. While all labs passed within- and between-laboratory reproducibility criteria given by OECD TG429 PS based on ECt values, statistical evaluation based on SI values showed that only two labs succeeded in achieving within-laboratory reproducibility. For those two labs that satisfied the within-lab reproducibility, between-laboratory reproducibility could be also attained based on inferential as well as descriptive statistics. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

[Serodiagnosis of toxoplasmosis: a comparative multicenter study of a standard scale through various actual tests and expression of the results in international units. Groupe de travail toxoplasmose du Contrôle national de qualité en parasotologie. Syndicat des fabricants de réactifs de laboratoire. Groupe de travail standardisation des tests sérologiques du Réseau européen de lutte contre la toxoplasmose congénitale].

PubMed

Petithory, J C; Ambroise-Thomas, P; De Loye, J; Pelloux, H; Goullier-Fleuret, A; Milgram, M; Buffard, C; Garin, J P

1996-01-01

Reported are the results of a multicentre study involving 40 laboratories that was carried out in France to assess all the currently available methods used for the serodiagnosis of toxoplasmosis. For this purpose 10 batches of control sera were prepared with titres in the range 0-260 IU per ml. These sera were tested in nine laboratories using immunofluorescence methods; in three laboratories using dye tests; in forty laboratories using enzyme-linked immunosorbent assay; in four laboratories using direct agglutination and haemagglutination; in seven laboratories using the high-sensitivity IgG agglutination test; and in three laboratories using the latex agglutination test. In this way, 70 series of titrations were carried out using seven procedures and the results were compared with those obtained using the WHO reference serum in 15 cases, with the French national E6 serum in 16 other cases, and in 39 cases using 15 reference sera supplied by the reagent manufacturers. Rigorous comparison of the tests was not possible in all cases because one aim of the study was to ensure that the tests were carried out under the usual working conditions that prevailed in the participating laboratories. The results obtained indicate that the serological tests currently available for toxoplasmosis are acceptable for its serodiagnosis. Presentation of the titres in IU has advantages; however, caution is required since the definition of IU varies according to the test and reagents used. It is therefore essential that the conditions and limits for a positive reaction be carefully defined in each case, especially for commercially available kits.

Environmental Chemistry Methods (ECM) Index - 0-9

EPA Pesticide Factsheets

Laboratories use testing methods to identify pesticides in water and soil. Environmental chemistry methods test soil and water samples to determine the fate of pesticides in the environment. Find methods for chemicals with a number as the first character.

An audit of the laboratory diagnosis of cryptosporidiosis in England and Wales.

PubMed

Chalmers, Rachel M; Atchison, Christina; Barlow, Katrina; Young, Yvonne; Roche, Anita; Manuel, Rohini

2015-07-01

To assess the level of practice consistent with UK national standards for Cryptosporidium testing, an audit was performed of 156 publicly funded clinical microbiology laboratories in England and Wales between August 2013 and April 2014. Responses were received from 85 (54 %) laboratories. First line diagnostic methods used were mainly microscopy with modified Ziehl-Neelsen (mZN) or auramine phenol (AP) staining (68/85, 80 %), enzyme immunoassays (EIAs) (16/85, 19 %) or in-house PCR (1/85, 1 %). The use of EIAs was more widespread than reported previously. Various methods were used for confirmation of positive EIA reactions and laboratories frequently resorted to sending samples to the national reference laboratory for this purpose, indicating that guidance is required for performance monitoring and confirmation of positive reactions. Laboratory positivity rates were related to the diagnostic test used, with highest median rates reported by those using PCR, EIAs or AP microscopy, and the lowest by those using mZN microscopy. One-third of responding laboratories (28/85, 33 %) routinely tested all stools for Cryptosporidium. However, 16 (19 %) laboratories used stool consistency to decide whether to test for this parasite. Other selection criteria included patient age (n = 18; 21 % laboratories), history or clinical details (n = 40; 47 %), duration of hospitalization (n = 18; 21 %) or clinician requests (n = 25; 29 %). To encourage laboratories to test all stools submitted for the investigation of diarrhoeal illness for Cryptosporidium, revision of the guidance in the national standards is under way. This will enable improved assessment of the burden of illness and ability to monitor outbreaks, and measure changes in reported cases.

Reporting Results of Molecular Tests: A Retrospective Examination of BRAF Mutation Reporting.

PubMed

Treece, Amanda L; Gulley, Margaret L; Vasalos, Patricia; Paquette, Cherie; Lindeman, Neal I; Jennings, Lawrence J; Bartley, Angela N

2017-05-01

- With enormous growth in the field of molecular pathology, the reporting of results gleaned from this testing is essential to guide patient care. - To examine molecular reports from laboratories participating in proficiency testing for required elements to convey molecular laboratory test results to clinicians and patients. - Molecular laboratories participating in the College of American Pathologists (CAP) proficiency testing program for BRAF mutation analysis were solicited to submit examples of final reports from 2 separate proficiency testing reporting cycles. Reports were reviewed for the presence or absence of relevant components. - A total of 107 evaluable reports were received (57 demonstrating a positive result for the BRAF V600E mutation and 50 negative). Methods for BRAF testing varied, with 95% (102 of 107) of reports adequately describing their assay methods and 87% (93 of 107) of reports adequately describing the target(s) of their assays. Information on the analytic sensitivity of the assay was present in 74% (79 of 107) of reports and 83% (89 of 107) reported at least 1 assay limitation, though only 34% (36 of 107) reported on variants not detected by their assays. Analytic and clinical interpretive comments were included in 99% (106 of 107) and 90% (96 of 107) of reports, respectively. Of participants that perform a laboratory-developed test, 88% (88 of 100) included language addressing the development of the assay. - Laboratories participating in BRAF proficiency testing through the CAP are including most of the required reporting elements to unambiguously convey molecular results. Laboratories should continue to strive to report these results in a concise and comprehensive manner.

List of Laboratories Approved by EPA for the Fourth Unregulated Contaminant Monitoring Rule (UCMR 4)

EPA Pesticide Factsheets

This document provides a list of laboratories that met the Unregulated Contaminant Monitoring Rule 4 (UCMR 4) Laboratory Approval Program application and Proficiency Testing (PT) criteria for the methods indicated.

List of Laboratories Approved by EPA for the Third Unregulated Contaminant Monitoring Rule (UCMR 3)

EPA Pesticide Factsheets

This document provides a list of laboratories that met the Unregulated Contaminant Monitoring Rule 3 (UCMR 3) Laboratory Approval Program application and Proficiency Testing (PT) criteria for the methods indicated.

Analytical difficulties facing today's regulatory laboratories: issues in method validation.

PubMed

MacNeil, James D

2012-08-01

The challenges facing analytical laboratories today are not unlike those faced in the past, although both the degree of complexity and the rate of change have increased. Challenges such as development and maintenance of expertise, maintenance and up-dating of equipment, and the introduction of new test methods have always been familiar themes for analytical laboratories, but international guidelines for laboratories involved in the import and export testing of food require management of such changes in a context which includes quality assurance, accreditation, and method validation considerations. Decisions as to when a change in a method requires re-validation of the method or on the design of a validation scheme for a complex multi-residue method require a well-considered strategy, based on a current knowledge of international guidance documents and regulatory requirements, as well the laboratory's quality system requirements. Validation demonstrates that a method is 'fit for purpose', so the requirement for validation should be assessed in terms of the intended use of a method and, in the case of change or modification of a method, whether that change or modification may affect a previously validated performance characteristic. In general, method validation involves method scope, calibration-related parameters, method precision, and recovery. Any method change which may affect method scope or any performance parameters will require re-validation. Some typical situations involving change in methods are discussed and a decision process proposed for selection of appropriate validation measures. © 2012 John Wiley & Sons, Ltd.

Impact of Laboratory Test Use Strategies in a Turkish Hospital

PubMed Central

Yılmaz, Fatma Meriç; Kahveci, Rabia; Aksoy, Altan; Özer Kucuk, Emine; Akın, Tezcan; Mathew, Joseph Lazar; Meads, Catherine; Zengin, Nurullah

2016-01-01

Objectives Eliminating unnecessary laboratory tests is a good way to reduce costs while maintain patient safety. The aim of this study was to define and process strategies to rationalize laboratory use in Ankara Numune Training and Research Hospital (ANH) and calculate potential savings in costs. Methods A collaborative plan was defined by hospital managers; joint meetings with ANHTA and laboratory professors were set; the joint committee invited relevant staff for input, and a laboratory efficiency committee was created. Literature was reviewed systematically to identify strategies used to improve laboratory efficiency. Strategies that would be applicable in local settings were identified for implementation, processed, and the impact on clinical use and costs assessed for 12 months. Results Laboratory use in ANH differed enormously among clinics. Major use was identified in internal medicine. The mean number of tests per patient was 15.8. Unnecessary testing for chloride, folic acid, free prostate specific antigen, hepatitis and HIV testing were observed. Test panel use was pinpointed as the main cause of overuse of the laboratory and the Hospital Information System test ordering page was reorganized. A significant decrease (between 12.6–85.0%) was observed for the tests that were taken to an alternative page on the computer screen. The one year study saving was equivalent to 371,183 US dollars. Conclusion Hospital-based committees including laboratory professionals and clinicians can define hospital based problems and led to a standardized approach to test use that can help clinicians reduce laboratory costs through appropriate use of laboratory tests. PMID:27077653

Integrated Data Collection Analysis (IDCA) Program - KClO 4/Carbon Mixture

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

Sandstrom, Mary M.; Brown, Geoffrey W.; Preston, Daniel N.

The Integrated Data Collection Analysis (IDCA) program is conducting a proficiency study for Small- Scale Safety and Thermal (SSST) testing of homemade explosives (HMEs). Described here are the results for impact, friction, electrostatic discharge, and differential scanning calorimetry analysis of a mixture of KClO 4 and activated carbon—KClO 4/C mixture. This material was selected because of the challenge of performing SSST testing of a mixture of two solids. The mixture was found to be insensitive to impact, friction, and thermal stimulus, and somewhat sensitive to spark discharge. This effort, funded by the Department of Homeland Security (DHS), ultimately will putmore » the issues of safe handling of these materials in perspective with standard military explosives. The study is adding SSST testing results for a broad suite of different HMEs to the literature. Ultimately the study has the potential to suggest new guidelines and methods and possibly establish the SSST testing accuracies needed to develop safe handling practices for HMEs. Each participating testing laboratory uses identical test materials and preparation methods wherever possible. Note, however, the test procedures differ among the laboratories. The results are compared among the laboratories and then compared to historical data from various sources. The testing performers involved for the KClO 4/carbon mixture are Lawrence Livermore National Laboratory (LLNL), Los Alamos National Laboratory (LANL), Indian Head Division, Naval Surface Warfare Center, (NSWC IHD), and Air Force Research Laboratory (AFRL/RXQL). These tests are conducted as a proficiency study in order to establish some consistency in test protocols, procedures, and experiments and to understand how to compare results when these testing variables cannot be made consistent.« less

Cognitive tests predict real-world errors: the relationship between drug name confusion rates in laboratory-based memory and perception tests and corresponding error rates in large pharmacy chains

PubMed Central

Schroeder, Scott R; Salomon, Meghan M; Galanter, William L; Schiff, Gordon D; Vaida, Allen J; Gaunt, Michael J; Bryson, Michelle L; Rash, Christine; Falck, Suzanne; Lambert, Bruce L

2017-01-01

Background Drug name confusion is a common type of medication error and a persistent threat to patient safety. In the USA, roughly one per thousand prescriptions results in the wrong drug being filled, and most of these errors involve drug names that look or sound alike. Prior to approval, drug names undergo a variety of tests to assess their potential for confusability, but none of these preapproval tests has been shown to predict real-world error rates. Objectives We conducted a study to assess the association between error rates in laboratory-based tests of drug name memory and perception and real-world drug name confusion error rates. Methods Eighty participants, comprising doctors, nurses, pharmacists, technicians and lay people, completed a battery of laboratory tests assessing visual perception, auditory perception and short-term memory of look-alike and sound-alike drug name pairs (eg, hydroxyzine/hydralazine). Results Laboratory test error rates (and other metrics) significantly predicted real-world error rates obtained from a large, outpatient pharmacy chain, with the best-fitting model accounting for 37% of the variance in real-world error rates. Cross-validation analyses confirmed these results, showing that the laboratory tests also predicted errors from a second pharmacy chain, with 45% of the variance being explained by the laboratory test data. Conclusions Across two distinct pharmacy chains, there is a strong and significant association between drug name confusion error rates observed in the real world and those observed in laboratory-based tests of memory and perception. Regulators and drug companies seeking a validated preapproval method for identifying confusing drug names ought to consider using these simple tests. By using a standard battery of memory and perception tests, it should be possible to reduce the number of confusing look-alike and sound-alike drug name pairs that reach the market, which will help protect patients from potentially harmful medication errors. PMID:27193033

77 FR 41188 - Clinical Laboratory Improvement Advisory Committee (CLIAC)

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-12

... technological advances, such as new test methods and the electronic transmission of laboratory information... potential need for educational materials and resources for sites that test under a Provider-performed Microscopy Certificate; and the increased use of culture-independent microbiology diagnostics and the impact...

Investigation of laboratory test procedures for assessing the structural capacity of geogrid-reinforced aggregate base materials.

DOT National Transportation Integrated Search

2015-04-01

The objective of this research was to identify a laboratory test method that can be used to quantify improvements in structural capacity of aggregate base materials reinforced with geogrid. For this research, National Cooperative Highway Research Pro...

Preventing Boredom in the Language Laboratory

ERIC Educational Resources Information Center

Obanya, Pai

1978-01-01

An experimental year of oral testing using the language laboratory at Victoria University is described. A new first-year 12-credit course is primarily a language course based on audiovisual/lingual methods. The content, evaluation, and administration of oral expression tests and performance tapes are covered. (SW)

Performance Assessment of Internal Quality Control (IQC) Products in Blood Transfusion Compatibility Testing in China

PubMed Central

Li, Jing-Jing; Gao, Qi; Liu, Zhi-Dong; Kang, Qiong-Hua; Hou, Yi-Jun; Zhang, Luo-Chuan; Hu, Xiao-Mei; Li, Jie; Zhang, Juan

2015-01-01

Internal quality control (IQC) is a critical component of laboratory quality management, and IQC products can determine the reliability of testing results. In China, given the fact that most blood transfusion compatibility laboratories do not employ IQC products or do so minimally, there is a lack of uniform and standardized IQC methods. To explore the reliability of IQC products and methods, we studied 697 results from IQC samples in our laboratory from 2012 to 2014. The results showed that the sensitivity and specificity of the IQCs in anti-B testing were 100% and 99.7%, respectively. The sensitivity and specificity of the IQCs in forward blood typing, anti-A testing, irregular antibody screening, and cross-matching were all 100%. The reliability analysis indicated that 97% of anti-B testing results were at a 99% confidence level, and 99.9% of forward blood typing, anti-A testing, irregular antibody screening, and cross-matching results were at a 99% confidence level. Therefore, our IQC products and methods are highly sensitive, specific, and reliable. Our study paves the way for the establishment of a uniform and standardized IQC method for pre-transfusion compatibility testing in China and other parts of the world. PMID:26488582

7 CFR 160.17 - Laboratory analysis.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Laboratory analysis. 160.17 Section 160.17 Agriculture... STANDARDS FOR NAVAL STORES Methods of Analysis, Inspection, Sampling and Grading § 160.17 Laboratory analysis. The analysis and laboratory testing of naval stores shall be conducted, so far as is practicable...

7 CFR 160.17 - Laboratory analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Laboratory analysis. 160.17 Section 160.17 Agriculture... STANDARDS FOR NAVAL STORES Methods of Analysis, Inspection, Sampling and Grading § 160.17 Laboratory analysis. The analysis and laboratory testing of naval stores shall be conducted, so far as is practicable...

Building Diversified Multiple Trees for classification in high dimensional noisy biomedical data.

PubMed

Li, Jiuyong; Liu, Lin; Liu, Jixue; Green, Ryan

2017-12-01

It is common that a trained classification model is applied to the operating data that is deviated from the training data because of noise. This paper will test an ensemble method, Diversified Multiple Tree (DMT), on its capability for classifying instances in a new laboratory using the classifier built on the instances of another laboratory. DMT is tested on three real world biomedical data sets from different laboratories in comparison with four benchmark ensemble methods, AdaBoost, Bagging, Random Forests, and Random Trees. Experiments have also been conducted on studying the limitation of DMT and its possible variations. Experimental results show that DMT is significantly more accurate than other benchmark ensemble classifiers on classifying new instances of a different laboratory from the laboratory where instances are used to build the classifier. This paper demonstrates that an ensemble classifier, DMT, is more robust in classifying noisy data than other widely used ensemble methods. DMT works on the data set that supports multiple simple trees.

Changes in Ultrasonic Velocity from Fluid Substitution, Calculated with Laboratory Methods, Digital Rock Physics, and Biot Theory

NASA Astrophysics Data System (ADS)

Goldfarb, E. J.; Ikeda, K.; Tisato, N.

2017-12-01

Seismic and ultrasonic velocities of rocks are function of several variables including fluid saturation and type. Understanding the effect of each variable on elastic waves can be valuable when using seismic methods for subsurface modeling. Fluid type and saturation are of specific interest to volcanology, water, and hydrocarbon exploration. Laboratory testing is often employed to understand the effects of fluids on elastic waves. However, laboratory testing is expensive and time consuming. It normally requires cutting rare samples into regular shapes. Fluid injection can also destroy specimens as removing the fluid after testing can prove difficult. Another option is theoretical modeling, which can be used to predict the effect of fluids on elastic properties, but it is often inaccurate. Alternatively, digital rock physics (DRP) can be used to investigate the effect of fluid substitution. DRP has the benefit of being non invasive, as it does not require regular sample shapes or fluid injection. Here, we compare the three methods for dry and saturated Berea sandstone to test the reliability of DRP. First, ultrasonic velocities were obtained from laboratory testing. Second, for comparison, we used a purely theoretical approach - i.e., Hashin-Shtrikman and Biot theory - to estimate the wave speeds at dry and wet conditions. Third, we used DRP. The dry sample was scanned with micro Computed Tomography (µCT), and a three dimensional (3D) array was recorded. We employed a segmentation-less method to convert each 3D array value to density, porosity, elastic moduli, and wave speeds. Wave propagation was simulated numerically at similar frequency as the laboratory. To simulate fluid substitution, we numerically substituted air values for water and repeated the simulation. The results from DRP yielded similar velocities to the laboratory, and accurately predicted the velocity change from fluid substitution. Theoretical modeling could not accurately predict velocity, and under-predicted the velocity change from fluid substitution. The mathematical approach proved to be a poor comparison for the laboratory measurement. DRP proved to be effective, and could be used in future with drill cuttings, perhaps to limit the use of expensive cores. DRP could also limit the requirement for physically testing fluid substitution.

Accreditation of medical laboratories in Croatia--experiences of the Institute of Clinical Chemistry, University Hospital "Merkur", Zagreb.

PubMed

Flegar-Mestrić, Zlata; Nazor, Aida; Perkov, Sonja; Surina, Branka; Kardum-Paro, Mirjana Mariana; Siftar, Zoran; Sikirica, Mirjana; Sokolić, Ivica; Ozvald, Ivan; Vidas, Zeljko

2010-03-01

Since 2003 when the international norm for implementation of quality management in medical laboratories (EN ISO 15189, Medical laboratories--Particular requirements for quality and competence) was established and accepted, accreditation has become practical, generally accepted method of quality management and confirmation of technical competence of medical laboratories in the whole world. This norm has been translated into Croatian and accepted by the Croatian Institute for Norms as Croatian norm. Accreditation is carried out on voluntary basis by the Croatian Accreditation Agency that has up to now accredited two clinical medical biochemical laboratories in the Republic of Croatia. Advantages of accredited laboratory lie in its documented management system, constant improvement and training, reliability of test results, establishing users' trust in laboratory services, test results comparability and interlaboratory (international) test results acceptance by adopting the concept of metrological traceability in laboratory medicine.

ECM for Aldicarb in Soil - MRID 49477402

EPA Pesticide Factsheets

laboratories use testing methods to identify pesticides in water and soil. Environmental chemistry methods test soil and water samples to determine the fate of pesticides in the environment. Find methods for chemicals with A as the first character.

Do we really need in-situ bioassays?

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

Salazar, M.H.; Salazar, S.M.

1995-12-31

In-situ bioassays are needed to validate the results from laboratory testing and to understand biological interactions. Standard laboratory protocols provide reproducible test results, and the precision of those tests can be mathematically defined. Significant correlations between toxic substances and levels of response (bioaccumulation and bioeffects) have also been demonstrated with natural field populations and suggest that the laboratory results can accurately predict field responses. An equal number of studies have shown a lack of correlation between laboratory bioassay results and responses of natural field populations. The best way to validate laboratory results is with manipulative field testing; i.e., in-situ bioassaysmore » with caged organisms. Bioaccumulation in transplanted bivalves has probably been the most frequently used form of an in-situ bioassay. The authors have refined those methods to include synoptic measurements of bioaccumulation and growth. Growth provides an easily-measured bioeffects endpoint and a means of calibrating bioaccumulation. Emphasis has been on minimizing the size range of test animals, repetitive measurements of individuals and standardization of test protocols for a variety of applications. They are now attempting to standardize criteria for accepting and interpreting data in the same way that laboratory bioassays have been standardized. Others have developed methods for in-situ bioassays using eggs, larvae, unicellular organisms, crustaceans, benthic invertebrates, bivalves, and fish. In the final analysis, the in-situ approach could be considered as an exposure system where any clinical measurements are possible. The most powerful approach would be to use the same species in laboratory and field experiments with the same endpoints.« less

Collaborative Testing in Practical Laboratories: An Effective Teaching-Learning Method in Histology.

PubMed

Guo, Yuping; Li, Enzhong

2016-01-01

This article presents an experimental teaching and learning program used in histology with first-year students in the second term in the Faculty of Biology at Huanghuai University, China. Eighty-six students were divided randomly into two groups (n=43 per group). Tests were conducted at the end of each practical laboratory (10 laboratories in total) in which collaborative testing was used in the experimental group and traditional testing in the control group. To assess achievement, a final examination in histology was carried out at the end of the course. To determine students' attitude to the teaching styles, a questionnaire survey was conducted at the end of the term. Results showed that students preferred the collaborative testing format. In the experimental group, students' scores were significantly higher than those of students in the control group in final examinations. These findings indicate that collaborative testing enhances student learning and understanding of the material taught, and suggest that collaborative testing is an effective teaching-learning method in histology.

Standardization in laboratory medicine: Adoption of common reference intervals to the Croatian population.

PubMed

Flegar-Meštrić, Zlata; Perkov, Sonja; Radeljak, Andrea

2016-03-26

Considering the fact that the results of laboratory tests provide useful information about the state of health of patients, determination of reference value is considered an intrinsic part in the development of laboratory medicine. There are still huge differences in the analytical methods used as well as in the associated reference intervals which could consequently significantly affect the proper assessment of patient health. In a constant effort to increase the quality of patients' care, there are numerous international initiatives for standardization and/or harmonization of laboratory diagnostics in order to achieve maximum comparability of laboratory test results and improve patient safety. Through the standardization and harmonization processes of analytical methods the ability to create unique reference intervals is achieved. Such reference intervals could be applied globally in all laboratories using methods traceable to the same reference measuring system and analysing the biological samples from the populations with similar socio-demographic and ethnic characteristics. In this review we outlined the results of the harmonization processes in Croatia in the field of population based reference intervals for clinically relevant blood and serum constituents which are in accordance with ongoing activity for worldwide standardization and harmonization based on traceability in laboratory medicine.

Standardization in laboratory medicine: Adoption of common reference intervals to the Croatian population

PubMed Central

Flegar-Meštrić, Zlata; Perkov, Sonja; Radeljak, Andrea

2016-01-01

Considering the fact that the results of laboratory tests provide useful information about the state of health of patients, determination of reference value is considered an intrinsic part in the development of laboratory medicine. There are still huge differences in the analytical methods used as well as in the associated reference intervals which could consequently significantly affect the proper assessment of patient health. In a constant effort to increase the quality of patients’ care, there are numerous international initiatives for standardization and/or harmonization of laboratory diagnostics in order to achieve maximum comparability of laboratory test results and improve patient safety. Through the standardization and harmonization processes of analytical methods the ability to create unique reference intervals is achieved. Such reference intervals could be applied globally in all laboratories using methods traceable to the same reference measuring system and analysing the biological samples from the populations with similar socio-demographic and ethnic characteristics. In this review we outlined the results of the harmonization processes in Croatia in the field of population based reference intervals for clinically relevant blood and serum constituents which are in accordance with ongoing activity for worldwide standardization and harmonization based on traceability in laboratory medicine. PMID:27019800

CAP/ACMG proficiency testing for biochemical genetics laboratories: a summary of performance.

PubMed

Oglesbee, Devin; Cowan, Tina M; Pasquali, Marzia; Wood, Timothy C; Weck, Karen E; Long, Thomas; Palomaki, Glenn E

2018-01-01

PurposeTesting for inborn errors of metabolism is performed by clinical laboratories worldwide, each utilizing laboratory-developed procedures. We sought to summarize performance in the College of American Pathologists' (CAP) proficiency testing (PT) program and identify opportunities for improving laboratory quality. When evaluating PT data, we focused on a subset of laboratories that have participated in at least one survey since 2010.MethodsAn analysis of laboratory performance (2004 to 2014) on the Biochemical Genetics PT Surveys, a program administered by CAP and the American College of Medical Genetics and Genomics. Analytical and interpretive performance was evaluated for four tests: amino acids, organic acids, acylcarnitines, and mucopolysaccharides.ResultsSince 2010, 150 laboratories have participated in at least one of four PT surveys. Analytic sensitivities ranged from 88.2 to 93.4%, while clinical sensitivities ranged from 82.4 to 91.0%. Performance was higher for US participants and for more recent challenges. Performance was lower for challenges with subtle findings or complex analytical patterns.ConclusionUS clinical biochemical genetics laboratory proficiency is satisfactory, with a minority of laboratories accounting for the majority of errors. Our findings underscore the complex nature of clinical biochemical genetics testing and highlight the necessity of continuous quality management.

In vitro susceptibility of filamentous fungi to itraconazole, voriconazole and posaconazole by Clinical and Laboratory Standards Institute reference method and E-test.

PubMed

Kondori, N; Svensson, E; Mattsby-Baltzer, I

2011-09-01

The use of anti-fungal agents has increased dramatically in recent years and new drugs have been developed. Several methods are available for determinations of their specific biological activities, i.e. the standard method for minimum inhibitory concentration-determination is described in M-38 [Clinical and Laboratory Standards Institute document M-38 (CLSI M-38)]. However, alternative methods, such as the E-test, are currently available in Mycology laboratories. The susceptibilities of clinical isolates of Aspergillus spp. (n = 29), Fusarium spp. (n = 5), zygomycetes (n = 21) and Schizophyllum (n = 1) were determined for itraconazole, voriconazole and posaconazole, using the CLSI M-38-A broth dilution method and also by the E-test. A good overall agreement (83.7%) between the two methods for all drugs and organisms was observed. Analyses of voriconazole showed a better agreement (93%) between the methods than posaconazole and itraconazole (85% and 74% respectively). Aspergillus spp. were the most susceptible fungi to the anti-fungal agents tested in this study. Posaconazole was the most active drug against filamentous fungi in vitro, followed by itraconazole and voriconazole. The latter (voriconazole) demonstrated no significant in vitro activity against zygomycetes. © 2010 Blackwell Verlag GmbH.

Comparison of on-site field measured inorganic arsenic in rice with laboratory measurements using a field deployable method: Method validation.

PubMed

Mlangeni, Angstone Thembachako; Vecchi, Valeria; Norton, Gareth J; Raab, Andrea; Krupp, Eva M; Feldmann, Joerg

2018-10-15

A commercial arsenic field kit designed to measure inorganic arsenic (iAs) in water was modified into a field deployable method (FDM) to measure iAs in rice. While the method has been validated to give precise and accurate results in the laboratory, its on-site field performance has not been evaluated. This study was designed to test the method on-site in Malawi in order to evaluate its accuracy and precision in determination of iAs on-site by comparing with a validated reference method and giving original data on inorganic arsenic in Malawian rice and rice-based products. The method was validated by using the established laboratory-based HPLC-ICPMS. Statistical tests indicated there were no significant differences between on-site and laboratory iAs measurements determined using the FDM (p = 0.263, ά = 0.05) and between on-site measurements and measurements determined using HPLC-ICP-MS (p = 0.299, ά = 0.05). This method allows quick (within 1 h) and efficient screening of rice containing iAs concentrations on-site. Copyright © 2018 Elsevier Ltd. All rights reserved.

EGFR T790M mutation testing within the osimertinib AURA Phase I study.

PubMed

Dearden, Simon; Brown, Helen; Jenkins, Suzanne; Thress, Kenneth S; Cantarini, Mireille; Cole, Rebecca; Ranson, Malcolm; Jänne, Pasi A

2017-07-01

Reliable epidermal growth factor receptor (EGFR) mutation testing techniques are required to identify eligible patients with EGFR mutation/T790M positive advanced non-small cell lung cancer (NSCLC), for treatment with osimertinib (AZD9291), an oral, potent, irreversible EGFR tyrosine kinase inhibitor (TKI) selective for EGFR-TKI-sensitizing and T790M resistance mutations over wild-type EGFR. There is no current consensus regarding the best method to detect EGFR T790M mutations. The aim of this study was to describe the concordance between local testing, which used a variety of methods, and central testing, using the cobas ® EGFR Mutation Test, for EGFR-sensitizing mutations and the T790M resistance mutation. Tumor samples were obtained from all patients screened for inclusion onto the osimertinib Phase I expansion component of the AURA Phase I/II study (NCT01802632). Samples underwent central laboratory testing for EGFR-sensitizing mutations and T790M resistance mutation using the cobas ® EGFR Mutation Test. Results were compared with local laboratory test results, based on other testing methodologies including Sanger sequencing, therascreen ® , PNAClamp™, and Sequenom MassARRAY ® . Central laboratory testing was successful in 99% of samples passing histopathology review and testing success rates were comparable across the three central laboratories. Concordance between central and local testing for common sensitizing mutations was high (>98%) and concordance for the T790M mutation was also high (>90%). Tumor heterogeneity, along with other technical factors may have influenced this result. Within the osimertinib AURA Phase I study, EGFR mutation testing across three centralized laboratories using the cobas ® EGFR Mutation Test was feasible and successful, with strong concordance between local and central laboratory results, including for T790M. The cobas ® EGFR Mutation Test has subsequently been approved as the companion diagnostic test for osimertinib in the USA and Japan. Copyright © 2017 Elsevier B.V. All rights reserved.

Implementation of the soil compactor analyzer into test method TEX-113-E : technical report.

DOT National Transportation Integrated Search

2012-04-01

Test method Tex-113-E prepares laboratory aggregate base test specimens with an impact hammer : compactor. These specimens are used for compaction characteristics and design tests. Although the : historical Tex-113-E required a certain amount of comp...

Real-Time PCR in Clinical Microbiology: Applications for Routine Laboratory Testing

PubMed Central

Espy, M. J.; Uhl, J. R.; Sloan, L. M.; Buckwalter, S. P.; Jones, M. F.; Vetter, E. A.; Yao, J. D. C.; Wengenack, N. L.; Rosenblatt, J. E.; Cockerill, F. R.; Smith, T. F.

2006-01-01

Real-time PCR has revolutionized the way clinical microbiology laboratories diagnose many human microbial infections. This testing method combines PCR chemistry with fluorescent probe detection of amplified product in the same reaction vessel. In general, both PCR and amplified product detection are completed in an hour or less, which is considerably faster than conventional PCR detection methods. Real-time PCR assays provide sensitivity and specificity equivalent to that of conventional PCR combined with Southern blot analysis, and since amplification and detection steps are performed in the same closed vessel, the risk of releasing amplified nucleic acids into the environment is negligible. The combination of excellent sensitivity and specificity, low contamination risk, and speed has made real-time PCR technology an appealing alternative to culture- or immunoassay-based testing methods for diagnosing many infectious diseases. This review focuses on the application of real-time PCR in the clinical microbiology laboratory. PMID:16418529

INDOOR AIR EMISSIONS FROM OFFICE EQUIPMENT: TEST METHOD DEVELOPMENT AND POLLUTION PREVENTION OPPORTUNITIES

EPA Science Inventory

The report describes the development and evaluation of a large chamber test method for measuring emissions from dry-process photocopiers. The test method was developed in two phases. Phase 1 was a single-laboratory evaluation at Research Triangle Institute (RTI) using four, mid-r...

Effect of Accreditation on Accuracy of Diagnostic Tests in Medical Laboratories

PubMed Central

Jang, Mi-Ae; Yoon, Young Ahn; Song, Junghan; Kim, Jeong-Ho; Min, Won-Ki; Lee, Ji Sung

2017-01-01

Background Medical laboratories play a central role in health care. Many laboratories are taking a more focused and stringent approach to quality system management. In Korea, laboratory standardization efforts undertaken by the Korean Laboratory Accreditation Program (KLAP) and the Korean External Quality Assessment Scheme (KEQAS) may have facilitated an improvement in laboratory performance, but there are no fundamental studies demonstrating that laboratory standardization is effective. We analyzed the results of the KEQAS to identify significant differences between laboratories with or without KLAP and to determine the impact of laboratory standardization on the accuracy of diagnostic tests. Methods We analyzed KEQAS participant data on clinical chemistry tests such as albumin, ALT, AST, and glucose from 2010 to 2013. As a statistical parameter to assess performance bias between laboratories, we compared 4-yr variance index score (VIS) between the two groups with or without KLAP. Results Compared with the group without KLAP, the group with KLAP exhibited significantly lower geometric means of 4-yr VIS for all clinical chemistry tests (P<0.0001); this difference justified a high level of confidence in standardized services provided by accredited laboratories. Confidence intervals for the mean of each test in the two groups (accredited and non-accredited) did not overlap, suggesting that the means of the groups are significantly different. Conclusions These results confirmed that practice standardization is strongly associated with the accuracy of test results. Our study emphasizes the necessity of establishing a system for standardization of diagnostic testing. PMID:28224767

Development of a Contact Permeation Test Fixture and Method

DTIC Science & Technology

2013-04-01

direct contact with the skin, indicates the need for a quantitative contact test method. Comparison tests were conducted with VX on a standardized...Guide for the Care and Use of Laboratory Animals (8th ed.; National Research Council: Washington, DC, 2011). This test was also performed in...1 1.2 Development of a Contact-Based Permeation Test Method ........................................ 1 2. EXPERIMENTAL PROCEDURES

Integrated Data Collection Analysis (IDCA) Program - AN and Bullseye Smokeless Powder

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

Sandstrom, Mary M.; Brown, Geoffrey W.; Preston, Daniel N.

The Integrated Data Collection Analysis (IDCA) program is conducting a proficiency study for Small- Scale Safety and Thermal (SSST) testing of homemade explosives (HMEs). Described here are the results for impact, friction, electrostatic discharge, and differential scanning calorimetry analysis of ammonium nitrate (AN) mixed with Bullseye® smokeless powder (Gunpowder). The participants found the AN/Gunpowder to: 1) have a range of sensitivity to impact, comparable to or less than RDX, 2) be fairly insensitive to friction as measured by BAM and ABL, 3) have a range for ESD, from insensitive to more sensitive than PETN, and 4) have thermal sensitivity aboutmore » the same as PETN and Gunpowder. This effort, funded by the Department of Homeland Security (DHS), is putting the issues of safe handling of these materials in perspective with standard military explosives. The study is adding SSST testing results for a broad suite of different HMEs to the literature. Ultimately the study has the potential to suggest new guidelines and methods and possibly establish the SSST testing accuracies needed when developing safe handling practices for HMEs. Each participating testing laboratory uses identical test materials and preparation methods. Note, however, the test procedures differ among the laboratories. The testing performers involved are Lawrence Livermore National Laboratory (LLNL), Los Alamos National Laboratory (LANL), Indian Head Division, Naval Surface Warfare Center, (NSWC IHD), Sandia National Laboratories (SNL), and Air Force Research Laboratory (AFRL/RXQL). These tests are conducted as a proficiency study in order to establish some consistency in test protocols, procedures, and experiments and to compare results when these testing variables cannot be made consistent. Keywords: Small-scale safety testing, proficiency test, impact-, friction-, spark discharge-, thermal testing, round-robin test, safety testing protocols, HME, RDX, potassium perchlorate, potassium chlorate, sodium chlorate, sugar, dodecane, PETN, carbon, ammonium nitrate, Gunpowder, Bullseye® smokeless powder.« less

A new methodology for hydro-abrasive erosion tests simulating penstock erosive flow

NASA Astrophysics Data System (ADS)

Aumelas, V.; Maj, G.; Le Calvé, P.; Smith, M.; Gambiez, B.; Mourrat, X.

2016-11-01

Hydro-abrasive resistance is an important property requirement for hydroelectric power plant penstock coating systems used by EDF. The selection of durable coating systems requires an experimental characterization of coating performance. This can be achieved by performing accelerated and representative laboratory tests. In case of severe erosion induced by a penstock flow, there is no suitable method or standard representative of real erosive flow conditions. The presented study aims at developing a new methodology and an associated laboratory experimental device. The objective of the laboratory apparatus is to subject coated test specimens to wear conditions similar to the ones generated at the penstock lower generatrix in actual flow conditions. Thirteen preselected coating solutions were first been tested during a 45 hours erosion test. A ranking of the thirteen coating solutions was then determined after characterisation. To complete this first evaluation and to determine the wear kinetic of the four best coating solutions, additional erosion tests were conducted with a longer duration of 216 hours. A comparison of this new method with standardized tests and with real service operating flow conditions is also discussed. To complete the final ranking based on hydro-abrasive erosion tests, some trial tests were carried out on penstock samples to check the application method of selected coating systems. The paper gives some perspectives related to erosion test methodologies for materials and coating solutions for hydraulic applications. The developed test method can also be applied in other fields.

Full-life chronic toxicity of sodium salts to the mayfly Neocloeon triangulifer in tests with laboratory cultured food.

PubMed

Soucek, David J; Dickinson, Amy

2015-09-01

Although insects occur in nearly all freshwater ecosystems, few sensitive insect models exist for use in determining the toxicity of contaminants. The objectives of the present study were to adapt previously developed culturing and toxicity testing methods for the mayfly Neocloeon triangulifer (Ephemeroptera: Baetidae), and to further develop a method for chronic toxicity tests spanning organism ages of less than 24 h post hatch to adult emergence, using a laboratory cultured diatom diet. The authors conducted 96-h fed acute tests and full-life chronic toxicity tests with sodium chloride, sodium nitrate, and sodium sulfate. The authors generated 96-h median lethal concentrations (LC50s) of 1062 mg Cl/L (mean of 3 tests), 179 mg N-NO3 /L, and 1227 mg SO4 /L. Acute to chronic ratios ranged from 2.1 to 6.4 for chloride, 2.5 to 5.1 for nitrate, and 2.3 to 8.5 for sulfate. The endpoints related to survival and development time were consistently the most sensitive in the tests. The chronic values generated for chloride were in the same range as those generated by others using natural foods. Furthermore, our weight-versus-fecundity plots were similar to those previously published using the food culturing method on which the present authors' method was based, indicating good potential for standardization. The authors believe that the continued use of this sensitive mayfly species in laboratory studies will help to close the gap in understanding between standard laboratory toxicity test results and field-based observations of community impairment. © 2015 SETAC.

Diagnostic trends in Clostridium difficile detection in Finnish microbiology laboratories.

PubMed

Könönen, Eija; Rasinperä, Marja; Virolainen, Anni; Mentula, Silja; Lyytikäinen, Outi

2009-12-01

Due to increased interest directed to Clostridium difficile-associated infections, a questionnaire survey of laboratory diagnostics of toxin-producing C. difficile was conducted in Finland in June 2006. Different aspects pertaining to C. difficile diagnosis, such as requests and criteria used for testing, methods used for its detection, yearly changes in diagnostics since 1996, and the total number of investigations positive for C. difficile in 2005, were asked in the questionnaire, which was sent to 32 clinical microbiology laboratories, including all hospital-affiliated and the relevant private clinical microbiology laboratories in Finland. The situation was updated by phone and email correspondence in September 2008. In June 2006, 28 (88%) laboratories responded to the questionnaire survey; 24 of them reported routinely testing requested stool specimens for C. difficile. Main laboratory methods included toxin detection (21/24; 88%) and/or anaerobic culture (19/24; 79%). In June 2006, 18 (86%) of the 21 laboratories detecting toxins directly from feces, from the isolate, or both used methods for both toxin A (TcdA) and B (TcdB), whereas only one laboratory did so in 1996. By September 2008, all of the 23 laboratories performing diagnostics for C. difficile used methods for both TcdA and TcdB. In 2006, the number of specimens processed per 100,000 population varied remarkably between different hospital districts. In conclusion, culturing C. difficile is common and there has been a favorable shift in toxin detection practice in Finnish clinical microbiology laboratories. However, the variability in diagnostic activity reported in 2006 creates a challenge for national monitoring of the epidemiology of C. difficile and related diseases.

Diagnosis of coccidioidomycosis by culture: safety considerations, traditional methods, and susceptibility testing.

PubMed

Sutton, Deanna A

2007-09-01

The recovery of Coccidioides spp. by culture and confirmation utilizing the AccuProbe nucleic acid hybridization method by GenProbe remain the definitive diagnostic method. Biosafety considerations from specimen collection through culture confirmation in the mycology laboratory are critical, as acquisition of coccidioidomycosis by laboratory workers is well documented. The designation of Coccidioides spp. as select agents of potential bioterrorism has mandated strict regulation of their transport and inventory. The genus appears generally susceptible, in vitro, although no defined breakpoints exist. Susceptibility testing may assist in documenting treatment failures.

Promoting clinical and laboratory interaction by harmonization.

PubMed

Plebani, Mario; Panteghini, Mauro

2014-05-15

The lack of interchangeable results in current practice among clinical laboratories has underpinned greater attention to standardization and harmonization projects. Although the focus was mainly on the standardization and harmonization of measurement procedures and their results, the scope of harmonization goes beyond method and analytical results: it includes all other aspects of laboratory testing, including terminology and units, report formats, reference limits and decision thresholds, as well as test profiles and criteria for the interpretation of results. In particular, as evidence collected in last decades demonstrates that pre-pre- and post-post-analytical steps are more vulnerable to errors, harmonization initiatives should be performed to improve procedures and processes at the laboratory-clinical interface. Managing upstream demand, down-stream interpretation of laboratory results, and subsequent appropriate action through close relationships between laboratorians and clinicians remains a crucial issue of the laboratory testing process. Therefore, initiatives to improve test demand management from one hand and to harmonize procedures to improve physicians' acknowledgment of laboratory data and their interpretation from the other hand are needed in order to assure quality and safety in the total testing process. © 2013.

Regeneration of Exhausted Arsenic Adsorptive media of a Full Scale Treatment System

EPA Science Inventory

This presentation will describe the method and results of laboratory tests showing the feasibility of regenerating exhausted, iron-based, adsorptive media and the results of a follow up regeneration test at a full scale system in Twentynine Palms CA. The laboratory studies on se...

Review of the AGARD S and M panel evaluation program of the NASA-Lewis SRP approach to high-temperature LCF life prediction

NASA Technical Reports Server (NTRS)

Hirschberg, M. H.

1978-01-01

Twenty laboratories in six countries participated in testing their own materials of interest under their own laboratory conditions. In this way the results obtained provided validation of the Strainrange Partitioning (SRP) method for a wide range of materials and insured maximum usefulness to each of the participating laboratories. The various investigators shared their findings, thus providing the basis for an in-depth evaluation of the SRP method. While the results were variable from laboratory to laboratory, most investigators agreed that the SRP method was a significant step toward life prediction in the presence of high temperature and cyclic stresses.

Simple Flame Test Techniques Using Cotton Swabs

ERIC Educational Resources Information Center

Sanger, Michael J.; Phelps, Amy J.; Banks, Catherine

2004-01-01

Three alternative methods for performing flame tests using cheaply and easily available cotton swabs are described. These flame tests are useful for chemical demonstrations or laboratory experiments because they are quick and easy to perform with easy cleanup and disposal methods.

Statistics of software vulnerability detection in certification testing

NASA Astrophysics Data System (ADS)

Barabanov, A. V.; Markov, A. S.; Tsirlov, V. L.

2018-05-01

The paper discusses practical aspects of introduction of the methods to detect software vulnerability in the day-to-day activities of the accredited testing laboratory. It presents the approval results of the vulnerability detection methods as part of the study of the open source software and the software that is a test object of the certification tests under information security requirements, including software for communication networks. Results of the study showing the allocation of identified vulnerabilities by types of attacks, country of origin, programming languages used in the development, methods for detecting vulnerability, etc. are given. The experience of foreign information security certification systems related to the detection of certified software vulnerabilities is analyzed. The main conclusion based on the study is the need to implement practices for developing secure software in the development life cycle processes. The conclusions and recommendations for the testing laboratories on the implementation of the vulnerability analysis methods are laid down.

Implications of the introduction of laboratory demand management at primary care clinics in South Africa on laboratory expenditure

PubMed Central

Lekalakala, Ruth; Asmall, Shaidah; Cassim, Naseem

2016-01-01

Background Diagnostic health laboratory services are regarded as an integral part of the national health infrastructure across all countries. Clinical laboratory tests contribute substantially to health system goals of increasing quality of care and improving patient outcomes. Objectives This study aimed to analyse current laboratory expenditures at the primary healthcare (PHC) level in South Africa as processed by the National Health Laboratory Service and to determine the potential cost savings of introducing laboratory demand management. Methods A retrospective cross-sectional analysis of laboratory expenditures for the 2013/2014 financial year across 11 pilot National Health Insurance health districts was conducted. Laboratory expenditure tariff codes were cross-tabulated to the PHC essential laboratory tests list (ELL) to determine inappropriate testing. Data were analysed using a Microsoft Access database and Excel software. Results Approximately R35 million South African Rand (10%) of the estimated R339 million in expenditures was for tests that were not listed within the ELL. Approximately 47% of expenditure was for laboratory tests that were indicated in the algorithmic management of patients on antiretroviral treatment. The other main cost drivers for non-ELL testing included full blood count and urea, as well as electrolyte profiles usually requested to support management of patients on antiretroviral treatment. Conclusions Considerable annual savings of up to 10% in laboratory expenditure are possible at the PHC level by implementing laboratory demand management. In addition, to achieve these savings, a standardised PHC laboratory request form and some form of electronic gatekeeping system that must be supported by an educational component should be implemented. PMID:28879107

Laboratory diagnosis of Chlamydia pneumoniae infections

PubMed Central

Peeling, Rosanna W

1995-01-01

Chlamydia pneumoniae is an important cause of respiratory illness. There is a need for accurate and rapid laboratory diagnostic methods that will lead to improved patient care, appropriate use of antimicrobial therapy and a better understanding of the epidemiology of this emerging pathogen. Culture is highly specific but is technically demanding, expensive, has a long turnaround time and its sensitivity is highly dependent on transport conditions. Antigen detection tests such as enzyme immunoassay and direct fluorescent antibody assay, and molecular detection methods such as the polymerase chain reaction assay, may provide a rapid diagnosis without the requirement for stringent transport conditions. The results of these tests should be interpreted with caution until more thorough evaluation is available. Serology remains the method of choice. The limitations of different serological methods for the laboratory diagnosis of C pneumoniae are discussed. PMID:22514397

Clinical testing of BRCA1 and BRCA2: a worldwide snapshot of technological practices.

PubMed

Toland, Amanda Ewart; Forman, Andrea; Couch, Fergus J; Culver, Julie O; Eccles, Diana M; Foulkes, William D; Hogervorst, Frans B L; Houdayer, Claude; Levy-Lahad, Ephrat; Monteiro, Alvaro N; Neuhausen, Susan L; Plon, Sharon E; Sharan, Shyam K; Spurdle, Amanda B; Szabo, Csilla; Brody, Lawrence C

2018-01-01

Clinical testing of BRCA1 and BRCA2 began over 20 years ago. With the expiration and overturning of the BRCA patents, limitations on which laboratories could offer commercial testing were lifted. These legal changes occurred approximately the same time as the widespread adoption of massively parallel sequencing (MPS) technologies. Little is known about how these changes impacted laboratory practices for detecting genetic alterations in hereditary breast and ovarian cancer genes. Therefore, we sought to examine current laboratory genetic testing practices for BRCA1 / BRCA2 . We employed an online survey of 65 questions covering four areas: laboratory characteristics, details on technological methods, variant classification, and client-support information. Eight United States (US) laboratories and 78 non-US laboratories completed the survey. Most laboratories (93%; 80/86) used MPS platforms to identify variants. Laboratories differed widely on: (1) technologies used for large rearrangement detection; (2) criteria for minimum read depths; (3) non-coding regions sequenced; (4) variant classification criteria and approaches; (5) testing volume ranging from 2 to 2.5 × 10 5 tests annually; and (6) deposition of variants into public databases. These data may be useful for national and international agencies to set recommendations for quality standards for BRCA1/BRCA2 clinical testing. These standards could also be applied to testing of other disease genes.

Plasma creatinine in dogs: intra- and inter-laboratory variation in 10 European veterinary laboratories

PubMed Central

2011-01-01

Background There is substantial variation in reported reference intervals for canine plasma creatinine among veterinary laboratories, thereby influencing the clinical assessment of analytical results. The aims of the study was to determine the inter- and intra-laboratory variation in plasma creatinine among 10 veterinary laboratories, and to compare results from each laboratory with the upper limit of its reference interval. Methods Samples were collected from 10 healthy dogs, 10 dogs with expected intermediate plasma creatinine concentrations, and 10 dogs with azotemia. Overlap was observed for the first two groups. The 30 samples were divided into 3 batches and shipped in random order by postal delivery for plasma creatinine determination. Statistical testing was performed in accordance with ISO standard methodology. Results Inter- and intra-laboratory variation was clinically acceptable as plasma creatinine values for most samples were usually of the same magnitude. A few extreme outliers caused three laboratories to fail statistical testing for consistency. Laboratory sample means above or below the overall sample mean, did not unequivocally reflect high or low reference intervals in that laboratory. Conclusions In spite of close analytical results, further standardization among laboratories is warranted. The discrepant reference intervals seem to largely reflect different populations used in establishing the reference intervals, rather than analytical variation due to different laboratory methods. PMID:21477356

Field evaluation of an avian risk assessment model

USGS Publications Warehouse

Vyas, N.B.; Spann, J.W.; Hulse, C.S.; Borges, S.L.; Bennett, R.S.; Torrez, M.; Williams, B.I.; Leffel, R.

2006-01-01

We conducted two laboratory subacute dietary toxicity tests and one outdoor subacute dietary toxicity test to determine the effectiveness of the U.S. Environmental Protection Agency's deterministic risk assessment model for evaluating the potential of adverse effects to birds in the field. We tested technical-grade diazinon and its D Z N- 50W (50% diazinon active ingredient wettable powder) formulation on Canada goose (Branta canadensis) goslings. Brain acetylcholinesterase activity was measured, and the feathers and skin, feet. and gastrointestinal contents were analyzed for diazinon residues. The dose-response curves showed that diazinon was significantly more toxic to goslings in the outdoor test than in the laboratory tests. The deterministic risk assessment method identified the potential for risk to birds in general, but the factors associated with extrapolating from the laboratory to the field, and from the laboratory test species to other species, resulted in the underestimation of risk to the goslings. The present study indicates that laboratory-based risk quotients should be interpreted with caution.

Repeatability and validity of a field kit for estimation of cholinesterase in whole blood.

PubMed Central

London, L; Thompson, M L; Sacks, S; Fuller, B; Bachmann, O M; Myers, J E

1995-01-01

OBJECTIVES--To evaluate a spectrophotometric field kit (Test-Mate-OP) for repeatability and validity in comparison with reference laboratory methods and to model its anticipated sensitivity and specificity based on these findings. METHODS--76 farm workers between the age of 20 and 55, of whom 30 were pesticide applicators exposed to a range of organophosphates in the preceding 10 days, had blood taken for plasma cholinesterase (PCE) and erythrocyte cholinesterase (ECE) measurement by field kit or laboratory methods. Paired blinded duplicate samples were taken from subgroups in the sample to assess repeatability of laboratory and field kit methods. Field kits were also used to test venous blood in one subgroup. The variance obtained for the field kit tests was then applied to two hypothetical scenarios that used published action guidelines to model the kit's sensitivity and specificity. RESULTS--Repeatability for PCE was much poorer and for ECE slightly poorer than that of laboratory measures. A substantial upward bias for field kit ECE relative to laboratory measurements was found. Sensitivity of the kit to a 40% drop in PCE was 67%, whereas that for ECE was 89%. Specificity of the kit with no change in mean of the population was 100% for ECE and 91% for PCE. CONCLUSION--Field kit ECE estimation seems to be sufficiently repeatable for surveillance activities, whereas PCE does not. Repeatability of both tests seems to be too low for use in epidemiological dose-response investigations. Further research is indicated to characterise the upward bias in ECE estimation on the kit. PMID:7697143

Validation of a modification to Performance-Tested Method 010403: microwell DNA hybridization assay for detection of Listeria spp. in selected foods and selected environmental surfaces.

PubMed

Alles, Susan; Peng, Linda X; Mozola, Mark A

2009-01-01

A modification to Performance-Tested Method 010403, GeneQuence Listeria Test (DNAH method), is described. The modified method uses a new media formulation, LESS enrichment broth, in single-step enrichment protocols for both foods and environmental sponge and swab samples. Food samples are enriched for 27-30 h at 30 degrees C, and environmental samples for 24-48 h at 30 degrees C. Implementation of these abbreviated enrichment procedures allows test results to be obtained on a next-day basis. In testing of 14 food types in internal comparative studies with inoculated samples, there were statistically significant differences in method performance between the DNAH method and reference culture procedures for only 2 foods (pasteurized crab meat and lettuce) at the 27 h enrichment time point and for only a single food (pasteurized crab meat) in one trial at the 30 h enrichment time point. Independent laboratory testing with 3 foods showed statistical equivalence between the methods for all foods, and results support the findings of the internal trials. Overall, considering both internal and independent laboratory trials, sensitivity of the DNAH method relative to the reference culture procedures was 90.5%. Results of testing 5 environmental surfaces inoculated with various strains of Listeria spp. showed that the DNAH method was more productive than the reference U.S. Department of Agriculture-Food Safety and Inspection Service (USDA-FSIS) culture procedure for 3 surfaces (stainless steel, plastic, and cast iron), whereas results were statistically equivalent to the reference method for the other 2 surfaces (ceramic tile and sealed concrete). An independent laboratory trial with ceramic tile inoculated with L. monocytogenes confirmed the effectiveness of the DNAH method at the 24 h time point. Overall, sensitivity of the DNAH method at 24 h relative to that of the USDA-FSIS method was 152%. The DNAH method exhibited extremely high specificity, with only 1% false-positive reactions overall.

A laboratory medicine residency training program that includes clinical consultation and research.

PubMed

Spitzer, E D; Pierce, G F; McDonald, J M

1990-04-01

We describe a laboratory medicine residency training program that includes ongoing interaction with both clinical laboratories and clinical services as well as significant research experience. Laboratory medicine residents serve as on-call consultants in the interpretation of test results, design of testing strategies, and assurance of test quality. The consultative on-call beeper system was evaluated and is presented as an effective method of clinical pathology training that is well accepted by the clinical staff. The research component of the residency program is also described. Together, these components provide training in real-time clinical problem solving and prepare residents for the changing technological environment of the clinical laboratory. At the completion of the residency, the majority of the residents are qualified laboratory subspecialists and are also capable of running an independent research program.

First external quality assurance program of the Italian HLA-B*57:01 Network assessing the performance of clinical virology laboratories in HLA-B*57:01 testing.

PubMed

Meini, Genny; Dello Russo, Cinzia; Allice, Tiziano; Barresi, Renata; D'Arrigo, Roberta; Falasca, Francesca; Lipsi, Maria Rosaria; Paolucci, Stefania; Zanussi, Stefania; Antonetti, Raffaele; Baldanti, Fausto; Basaglia, Giancarlo; Bruzzone, Bianca; Polilli, Ennio; Ghisetti, Valeria; Pucillo, Leopoldo Paolo; Turriziani, Ombretta; Pirazzoli, Antonella; Navarra, Pierluigi; Zazzi, Maurizio

2016-05-01

Since the HLA-B*57:01 allele is strongly associated with abacavir hypersensitivity reaction, testing for the presence of HLA-B*57:01 is mandatory before administration of abacavir. While HLA-B*57:01 testing is usually provided by pharmacogenetics, genetics or blood transfusion services, clinical virology laboratories can be an optimal opportunity for HLA-B*57:01 testing since they receive blood samples for routine HIV monitoring and have the expertise for convenient and less expensive PCR-based point mutation assays. The Italian HLA-B*57:01 Network gathers accredited clinical virology laboratories offering HLA-B*57:01 testing in Italy with the aim to share protocols, test new methods, develop and maintain external quality assurance (EQA) programs. A panel of 9HLA-B*57:01-positive and 16HLA-B*57:01-negative frozen blood samples were blindly distributed to 10 units including 9 clinical virology laboratories and one reference pharmacology laboratory. Each laboratory was free to use its own routine method for DNA extraction and HLA-B*57:01 testing. DNA was extracted by automated workstations in 6 units and by manual spin columns in 4. Eight units used the Duplicα Real Time HLA-B*57:01 kit by Euroclone and two units used two different PCR homemade protocols. All the 10 units correctly identified all the 25 samples. The first HLA-B*57:01 EQA program run in Italy showed that clinical virology units are equipped and proficient for providing HLA-B*57:01 testing by inexpensive assays easy to integrate into their routine. Copyright © 2016 Elsevier B.V. All rights reserved.

Performance of the AOAC use-dilution method with targeted modifications: collaborative study.

PubMed

Tomasino, Stephen F; Parker, Albert E; Hamilton, Martin A; Hamilton, Gordon C

2012-01-01

The U.S. Environmental Protection Agency (EPA), in collaboration with an industry work group, spearheaded a collaborative study designed to further enhance the AOAC use-dilution method (UDM). Based on feedback from laboratories that routinely conduct the UDM, improvements to the test culture preparation steps were prioritized. A set of modifications, largely based on culturing the test microbes on agar as specified in the AOAC hard surface carrier test method, were evaluated in a five-laboratory trial. The modifications targeted the preparation of the Pseudomonas aeruginosa test culture due to the difficulty in separating the pellicle from the broth in the current UDM. The proposed modifications (i.e., the modified UDM) were compared to the current UDM methodology for P. aeruginosa and Staphylococcus aureus. Salmonella choleraesuis was not included in the study. The goal was to determine if the modifications reduced method variability. Three efficacy response variables were statistically analyzed: the number of positive carriers, the log reduction, and the pass/fail outcome. The scope of the collaborative study was limited to testing one liquid disinfectant (an EPA-registered quaternary ammonium product) at two levels of presumed product efficacies, high and low. Test conditions included use of 400 ppm hard water as the product diluent and a 5% organic soil load (horse serum) added to the inoculum. Unfortunately, the study failed to support the adoption of the major modification (use of an agar-based approach to grow the test cultures) based on an analysis of method's variability. The repeatability and reproducibility standard deviations for the modified method were equal to or greater than those for the current method across the various test variables. However, the authors propose retaining the frozen stock preparation step of the modified method, and based on the statistical equivalency of the control log densities, support its adoption as a procedural change to the current UDM. The current UDM displayed acceptable responsiveness to changes in product efficacy; acceptable repeatability across multiple tests in each laboratory for the control counts and log reductions; and acceptable reproducibility across multiple laboratories for the control log density values and log reductions. Although the data do not support the adoption of all modifications, the UDM collaborative study data are valuable for assessing sources of method variability and a reassessment of the performance standard for the UDM.

Current practice in laboratory diagnostics of autoimmune diseases in Croatia. 
Survey of the Working group for laboratory diagnostics of autoimmune diseases of the Croatian Society of Medical Biochemistry and Laboratory Medicine

PubMed Central

Kuna, Andrea Tešija; Đerek, Lovorka; Kozmar, Ana; Drvar, Vedrana

2016-01-01

Introduction With the trend of increasing incidence of autoimmune diseases, laboratories are faced with exponential growth of the requests for tests relating the diagnosis of these diseases. Unfortunately, the lack of laboratory personnel experienced in this specific discipline of laboratory diagnostic, as well as an unawareness of a method limitation often results in confusion for clinicians. The aim was to gain insight into number and type of Croatian laboratories that perform humoral diagnostics with the final goal to improve and harmonize laboratory diagnostics of autoimmune diseases in Croatia. Materials and methods In order to get insight into current laboratory practice two questionnaires, consisting of 42 questions in total, were created. Surveys were conducted using SurveyMonkey application and were sent to 88 medical biochemistry laboratories in Croatia for the first survey. Out of 33 laboratories that declared to perform diagnostic from the scope, 19 were selected for the second survey based on the tests they pleaded to perform. The survey comprised questions regarding autoantibody hallmarks of systemic autoimmune diseases while regarding organ-specific autoimmune diseases was limited to diseases of liver, gastrointestinal and nervous system. Results Response rate was high with 80 / 88 (91%) laboratories which answered the first questionnaire, and 19 / 19 (1.0) for the second questionnaire. Obtained results of surveys indicate high heterogeneity in the performance of autoantibody testing among laboratories in Croatia. Conclusions Results indicate the need of creating recommendations and algorithms in order to harmonize the approach to laboratory diagnostics of autoimmune diseases in Croatia. PMID:27812306

Cost-price estimation of clinical laboratory services based on activity-based costing: A case study from a developing country

PubMed Central

Mouseli, Ali; Barouni, Mohsen; Amiresmaili, Mohammadreza; Samiee, Siamak Mirab; Vali, Leila

2017-01-01

Background It is believed that laboratory tariffs in Iran don’t reflect the real costs. This might expose private laboratories at financial hardship. Activity Based Costing is widely used as a cost measurement instrument to more closely approximate the true cost of operations. Objective This study aimed to determine the real price of different clinical tests of a selected private clinical laboratory. Methods This study was a cross sectional study carried out in 2015. The study setting was the private laboratories in the city of Kerman, Iran. Of 629 tests in the tariff book of the laboratory (relative value), 188 tests were conducted in the laboratory that used Activity Based Costing (ABC) methodology to estimate cost-price. Analyzing and cost-price estimating of laboratory services were performed by MY ABCM software Version 5.0. Results In 2015, the total costs were $641,645. Direct and indirect costs were 78.3% and 21.7% respectively. Laboratory consumable costs by 37% and personnel costs by 36.3% had the largest share of the costing. Also, group of hormone tests cost the most $147,741 (23.03%), and other tests group cost the least $3,611 (0.56%). Also after calculating the cost of laboratory services, a comparison was made between the calculated price and the private sector’s tariffs in 2015. Conclusion This study showed that there was a difference between costs and tariffs in the private laboratory. One way to overcome this problem is to increase the number of laboratory tests with regard to capacity of the laboratories. PMID:28607638

Exploration of task performance tests in a physics laboratory

NASA Astrophysics Data System (ADS)

Liu, Dan; El Turkey, Houssein

2017-11-01

In this article, we investigate the implementation of task performance tests in an undergraduate physics laboratory. Two performance tests were carried out over two semesters using the task of building a DC circuit. The first implementation in Spring 2014 had certain concerns such as the privacy of students’ testing and their ‘trial and error’ attempts. These concerns were addressed in Fall 2015 through implementing a second performance test. The second implementation was administered differently but the content of the two tests was the same. We discuss the validity of both implementations and present the correlation (or lack of) between the time that students needed to complete the tests and their grades from a paper-based laboratory assessment method.

Review of laboratory-based terrestrial bioaccumulation assessment approaches for organic chemicals: Current status and future possibilities.

PubMed

Hoke, Robert; Huggett, Duane; Brasfield, Sandra; Brown, Becky; Embry, Michelle; Fairbrother, Anne; Kivi, Michelle; Paumen, Miriam Leon; Prosser, Ryan; Salvito, Dan; Scroggins, Rick

2016-01-01

In the last decade, interest has been renewed in approaches for the assessment of the bioaccumulation potential of chemicals, principally driven by the need to evaluate large numbers of chemicals as part of new chemical legislation, while reducing vertebrate test organism use called for in animal welfare legislation. This renewed interest has inspired research activities and advances in bioaccumulation science for neutral organic chemicals in aquatic environments. In January 2013, ILSI Health and Environmental Sciences Institute convened experts to identify the state of the science and existing shortcomings in terrestrial bioaccumulation assessment of neutral organic chemicals. Potential modifications to existing laboratory methods were identified, including areas in which new laboratory approaches or test methods could be developed to address terrestrial bioaccumulation. The utility of "non-ecotoxicity" data (e.g., mammalian laboratory data) was also discussed. The highlights of the workshop discussions are presented along with potential modifications in laboratory approaches and new test guidelines that could be used for assessing the bioaccumulation of chemicals in terrestrial organisms. © 2015 SETAC.

External quality assessment of dengue and chikungunya diagnostics in the Asia Pacific region, 2015

PubMed Central

Soh, Li Ting; Squires, Raynal C; Tan, Li Kiang; Pok, Kwoon Yong; Yang, HuiTing; Liew, Christina; Shah, Aparna Singh; Aaskov, John; Abubakar, Sazaly; Hasabe, Futoshi; Ng, Lee Ching

2016-01-01

Objective To conduct an external quality assessment (EQA) of dengue and chikungunya diagnostics among national-level public health laboratories in the Asia Pacific region following the first round of EQA for dengue diagnostics in 2013. Methods Twenty-four national-level public health laboratories performed routine diagnostic assays on a proficiency testing panel consisting of two modules. Module A contained serum samples spiked with cultured dengue virus (DENV) or chikungunya virus (CHIKV) for the detection of nucleic acid and DENV non-structural protein 1 (NS1) antigen. Module B contained human serum samples for the detection of anti-DENV antibodies. Results Among 20 laboratories testing Module A, 17 (85%) correctly detected DENV RNA by reverse transcription polymerase chain reaction (RT–PCR), 18 (90%) correctly determined serotype and 19 (95%) correctly identified CHIKV by RT–PCR. Ten of 15 (66.7%) laboratories performing NS1 antigen assays obtained the correct results. In Module B, 18/23 (78.3%) and 20/20 (100%) of laboratories correctly detected anti-DENV IgM and IgG, respectively. Detection of acute/recent DENV infection by both molecular (RT–PCR) and serological methods (IgM) was available in 19/24 (79.2%) participating laboratories. Discussion Accurate laboratory testing is a critical component of dengue and chikungunya surveillance and control. This second round of EQA reveals good proficiency in molecular and serological diagnostics of these diseases in the Asia Pacific region. Further comprehensive diagnostic testing, including testing for Zika virus, should comprise future iterations of the EQA. PMID:27508088

How Well Does Physician Selection of Microbiologic Tests Identify Clostridium difficile and other Pathogens in Paediatric Diarrhoea? Insights Using Multiplex PCR-Based Detection

PubMed Central

Stockmann, Chris; Rogatcheva, Margarita; Harrel, Brian; Vaughn, Mike; Crisp, Rob; Poritz, Mark; Thatcher, Stephanie; Korgenski, Ernest K; Barney, Trenda; Daly, Judy; Pavia, Andrew T

2014-01-01

The objective of this study was to compare the aetiologic yield of standard of care microbiologic testing ordered by physicians with that of a multiplex PCR platform. Stool specimens obtained from children and young adults with gastrointestinal illness were evaluated by standard laboratory methods and a developmental version of the FilmArray Gastrointestinal Diagnostic System (FilmArray GI Panel), a rapid multiplex PCR platform that detects 23 bacterial, viral, and protozoal agents. Results were classified according to the microbiologic tests requested by the treating physician. A median of 3 (range 1-10) microbiologic tests were performed by the clinical laboratory during 378 unique diarrhoeal episodes. A potential aetiologic agent was identified in 46% of stool specimens by standard laboratory methods and in 65% of specimens tested using the FilmArray GI Panel (P<0.001). For those patients who only had Clostridium difficile testing requested, an alternative pathogen was identified in 29% of cases with the FilmArray GI Panel. Notably, 11 (12%) cases of norovirus were identified among children who only had testing for C. difficile ordered. Among those who had C. difficile testing ordered in combination with other tests, an additional pathogen was identified in 57% of stool specimens with the FilmArray GI Panel. For patients who had no C. difficile testing performed, the FilmArray GI Panel identified a pathogen in 63% of cases, including C. difficile in 8%. Physician-specified laboratory testing may miss important diarrhoeal pathogens. Additionally, standard laboratory testing is likely to underestimate co-infections with multiple infectious diarrhoeagenic agents. PMID:25599941

[Knowledge management system for laboratory work and clinical decision support].

PubMed

Inada, Masanori; Sato, Mayumi; Yoneyama, Akiko

2011-05-01

This paper discusses a knowledge management system for clinical laboratories. In the clinical laboratory of Toranomon Hospital, we receive about 20 questions relevant to laboratory tests per day from medical doctors or co-medical staff. These questions mostly involve the essence to appropriately accomplish laboratory tests. We have to answer them carefully and suitably because an incorrect answer may cause a medical accident. Up to now, no method has been in place to achieve a rapid response and standardized answers. For this reason, the laboratory staff have responded to various questions based on their individual knowledge. We began to develop a knowledge management system to promote the knowledge of staff working for the laboratory. This system is a type of knowledge base for assisting the work, such as inquiry management, laboratory consultation, process management, and clinical support. It consists of several functions: guiding laboratory test information, managing inquiries from medical staff, reporting results of patient consultation, distributing laboratory staffs notes, and recording guidelines for laboratory medicine. The laboratory test information guide has 2,000 records of medical test information registered in the database with flexible retrieval. The inquiry management tool provides a methos to record all questions, answer easily, and retrieve cases. It helps staff to respond appropriately in a short period of time. The consulting report system treats patients' claims regarding medical tests. The laboratory staffs notes enter a file management system so they can be accessed to aid in clinical support. Knowledge sharing using this function can achieve the transition from individual to organizational learning. Storing guidelines for laboratory medicine will support EBM. Finally, it is expected that this system will support intellectual activity concerning laboratory work and contribute to the practice of knowledge management for clinical work support.

Evaluation of a standard test method for screening fuels in soils

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

Sorini, S.S.; Schabron, J.F.

1996-12-31

A new screening method for fuel contamination in soils was recently developed as American Society for Testing and Materials (ASTM) Method D-5831-95, Standard Test Method for Screening Fuels in Soils. This method uses low-toxicity chemicals and can be sued to screen organic- rich soils, as well as being fast, easy, and inexpensive to perform. Fuels containing aromatic compounds, such as diesel fuel and gasoline, as well as other aromatic-containing hydrocarbon materials, such as motor oil, crude oil, and cola oil, can be determined. The screening method for fuels in soils was evaluated by conducting a Collaborative study on the method.more » In the Collaborative study, a sand and an organic soil spiked with various concentrations of diesel fuel were tested. Data from the Collaborative study were used to determine the reproducibility (between participants) and repeatability (within participants) precision of the method for screening the test materials. The Collaborative study data also provide information on the performance of portable field equipment (patent pending) versus laboratory equipment for performing the screening method and a comparison of diesel concentration values determined using the screening method versus a laboratory method.« less

Lessons learned from implementing a wet laboratory molecular training workshop for beach water quality monitoring.

PubMed

Verhougstraete, Marc Paul; Brothers, Sydney; Litaker, Wayne; Blackwood, A Denene; Noble, Rachel

2015-01-01

Rapid molecular testing methods are poised to replace many of the conventional, culture-based tests currently used in fields such as water quality and food science. Rapid qPCR methods have the benefit of being faster than conventional methods and provide a means to more accurately protect public health. However, many scientists and technicians in water and food quality microbiology laboratories have limited experience using these molecular tests. To ensure that practitioners can use and implement qPCR techniques successfully, we developed a week long workshop to provide hands-on training and exposure to rapid molecular methods for water quality management. This workshop trained academic professors, government employees, private industry representatives, and graduate students in rapid qPCR methods for monitoring recreational water quality. Attendees were immersed in these new methods with hands-on laboratory sessions, lectures, and one-on-one training. Upon completion, the attendees gained sufficient knowledge and practice to teach and share these new molecular techniques with colleagues at their respective laboratories. Key findings from this workshop demonstrated: 1) participants with no prior experience could be effectively trained to conduct highly repeatable qPCR analysis in one week; 2) participants with different desirable outcomes required exposure to a range of different platforms and sample processing approaches; and 3) the collaborative interaction amongst newly trained practitioners, workshop leaders, and members of the water quality community helped foster a cohesive cohort of individuals which can advocate powerful cohort for proper implementation of molecular methods.

Lessons Learned from Implementing a Wet Laboratory Molecular Training Workshop for Beach Water Quality Monitoring

PubMed Central

Verhougstraete, Marc Paul; Brothers, Sydney; Litaker, Wayne; Blackwood, A. Denene; Noble, Rachel

2015-01-01

Rapid molecular testing methods are poised to replace many of the conventional, culture-based tests currently used in fields such as water quality and food science. Rapid qPCR methods have the benefit of being faster than conventional methods and provide a means to more accurately protect public health. However, many scientists and technicians in water and food quality microbiology laboratories have limited experience using these molecular tests. To ensure that practitioners can use and implement qPCR techniques successfully, we developed a week long workshop to provide hands-on training and exposure to rapid molecular methods for water quality management. This workshop trained academic professors, government employees, private industry representatives, and graduate students in rapid qPCR methods for monitoring recreational water quality. Attendees were immersed in these new methods with hands-on laboratory sessions, lectures, and one-on-one training. Upon completion, the attendees gained sufficient knowledge and practice to teach and share these new molecular techniques with colleagues at their respective laboratories. Key findings from this workshop demonstrated: 1) participants with no prior experience could be effectively trained to conduct highly repeatable qPCR analysis in one week; 2) participants with different desirable outcomes required exposure to a range of different platforms and sample processing approaches; and 3) the collaborative interaction amongst newly trained practitioners, workshop leaders, and members of the water quality community helped foster a cohesive cohort of individuals which can advocate powerful cohort for proper implementation of molecular methods. PMID:25822486

Problems in specimen collection for sexually transmitted diseases.

PubMed

Larsen, B

1985-03-01

Laboratory methods for the diagnosis of sexually transmitted diseases (STDs) are continuously undergoing improvement. It remains the responsibility of the clinician to become familiar with the tests available for the diagnosis of STDs. Those tests depend on obtaining clinical specimens from the proper site and on transporting them to the laboratory under satisfactory conditions.

A Laboratory Exercise for Compatibility Testing of Hazardous Wastes in an Environmental Analysis Course.

ERIC Educational Resources Information Center

Chang, J. C.; And Others

1986-01-01

Discusses a new program at the University of Michigan in hazardous waste management. Describes a laboratory demonstration that deals with the reactivity and potential violence of several reactions that may be encountered on a hazardous waste site. Provides criteria for selecting particular compatibility testing methods. (TW)

[An evaluation of the effectiveness of laboratory diagnostic methods for brucellosis].

PubMed

Gandara, B; Zheludkov, M M; Chernysheva, M I

1994-01-01

The diagnostic value of bacteriological and serological methods for the laboratory diagnosis of brucellosis was studied. In the analysis of milk and cheese specimens Brucella cultures were isolated and differentiated as B.melitensis, biovar I, and B.abortus, biovar 4. In 25.6% of cases B.melitensis culture, biovar 1, was isolated from the blood of persons suspected for brucellosis. The isolation of B.melitensis culture from milk showed that this infective agent migrated from small animals to cattle, which was indicative of a high risk of human infection in the state of Zacatecas, Mexico. The comparative evaluation of serological diagnostic methods (the agglutination test in test tubes, Huddleson's slide test, the acidic rose bengal test and the 2-mercaptoethanol test) showed high sensitivity of rapid tests (Huddleson's test and the rose bengal test in 93.7% and 87.9% of cases respectively). The 2-mercaptoethanol test which gave positive results in 63.8% of cases provided additional information characterizing the course of infections process.

Syphilis testing practices in the Americas.

PubMed

Trinh, Thuy T; Kamb, Mary L; Luu, Minh; Ham, D Cal; Perez, Freddy

2017-09-01

To present the findings of the Pan American Health Organization's 2014 survey on syphilis testing policies and practices in the Americas. Representatives of national/regional reference and large, lower-level laboratories from 35 member states were invited to participate. A semi-structured, electronically administered questionnaire collected data on syphilis tests, algorithms, equipment/commodities, challenges faced and basic quality assurance (QA) strategies employed (i.e. daily controls, standard operating procedures, technician training, participating in external QA programmes, on-site evaluations). The 69 participating laboratories from 30 (86%) member states included 41 (59%) national/regional reference and 28 (41%) lower-level laboratories. Common syphilis tests conducted were the rapid plasma reagin (RPR) (62% of surveyed laboratories), venereal disease research laboratory (VDRL) (54%), fluorescent treponemal antibody absorption (FTA-ABS) (41%) and Treponema pallidum haemagglutination assay (TPHA) (32%). Only three facilities reported using direct detection methods, and 28 (41% overall, 32% of lower-level facilities) used rapid tests. Most laboratories (62%) used only traditional testing algorithms (non-treponemal screening and treponemal confirmatory testing); however, 12% used only a reverse sequence algorithm (treponemal test first), and 14% employed both algorithms. Another nine (12%) laboratories conducted only one type of serologic test. Although most reference (97%) and lower-level (89%) laboratories used at least one QA strategy, only 16% reported using all five basic strategies. Commonly reported challenges were stock-outs of essential reagents or commodities (46%), limited staff training (73%) and insufficient equipment (39%). Many reference and clinical laboratories in the Americas face challenges in conducting appropriate syphilis testing and in ensuring quality of testing. © 2017 John Wiley & Sons Ltd The Pan-American Health Organization retains copyright and all other rights in the manuscript of this article as submitted for publication.

Numerical sedimentation particle-size analysis using the Discrete Element Method

NASA Astrophysics Data System (ADS)

Bravo, R.; Pérez-Aparicio, J. L.; Gómez-Hernández, J. J.

2015-12-01

Sedimentation tests are widely used to determine the particle size distribution of a granular sample. In this work, the Discrete Element Method interacts with the simulation of flow using the well known one-way-coupling method, a computationally affordable approach for the time-consuming numerical simulation of the hydrometer, buoyancy and pipette sedimentation tests. These tests are used in the laboratory to determine the particle-size distribution of fine-grained aggregates. Five samples with different particle-size distributions are modeled by about six million rigid spheres projected on two-dimensions, with diameters ranging from 2.5 ×10-6 m to 70 ×10-6 m, forming a water suspension in a sedimentation cylinder. DEM simulates the particle's movement considering laminar flow interactions of buoyant, drag and lubrication forces. The simulation provides the temporal/spatial distributions of densities and concentrations of the suspension. The numerical simulations cannot replace the laboratory tests since they need the final granulometry as initial data, but, as the results show, these simulations can identify the strong and weak points of each method and eventually recommend useful variations and draw conclusions on their validity, aspects very difficult to achieve in the laboratory.

New Rock Abrasivity Test Method for Tool Life Assessments on Hard Rock Tunnel Boring: The Rolling Indentation Abrasion Test (RIAT)

NASA Astrophysics Data System (ADS)

Macias, F. J.; Dahl, F.; Bruland, A.

2016-05-01

The tunnel boring machine (TBM) method has become widely used and is currently an important presence within the tunnelling industry. Large investments and high geological risk are involved using TBMs, and disc cutter consumption has a great influence on performance and cost, especially in hard rock conditions. Furthermore, reliable cutter life assessments facilitate the control of risk as well as avoiding delays and budget overruns. Since abrasive wear is the most common process affecting cutter consumption, good laboratory tests for rock abrasivity assessments are needed. A new abrasivity test method by rolling disc named Rolling Indentation Abrasion Test (RIAT) has been developed. The goal of the new test design and procedure is to reproduce wear behaviour on hard rock tunnel boring in a more realistic way than the traditionally used methods. Wear by rolling contact on intact rock samples is introduced and several rock types, covering a wide rock abrasiveness range, have been tested by RIAT. The RIAT procedure indicates a great ability of the testing method to assess abrasive wear on rolling discs. In addition and to evaluate the newly developed RIAT test method, a comprehensive laboratory testing programme including the most commonly used abrasivity test methods and the mineral composition were carried out. Relationships between the achieved results from conventional testing and RIAT results have been analysed.

The Effect of the Laboratory Specimen on Fatigue Crack Growth Rate

NASA Technical Reports Server (NTRS)

Forth, S. C.; Johnston, W. M.; Seshadri, B. R.

2006-01-01

Over the past thirty years, laboratory experiments have been devised to develop fatigue crack growth rate data that is representative of the material response. The crack growth rate data generated in the laboratory is then used to predict the safe operating envelope of a structure. The ability to interrelate laboratory data and structural response is called similitude. In essence, a nondimensional term, called the stress intensity factor, was developed that includes the applied stresses, crack size and geometric configuration. The stress intensity factor is then directly related to the rate at which cracks propagate in a material, resulting in the material property of fatigue crack growth response. Standardized specimen configurations and experimental procedures have been developed for laboratory testing to generate crack growth rate data that supports similitude of the stress intensity factor solution. In this paper, the authors present laboratory fatigue crack growth rate test data and finite element analyses that show similitude between standard specimen configurations tested using the constant stress ratio test method is unobtainable.

Policies and practices in haemostasis testing among laboratories in Croatia: a survey on behalf of a Working Group for Laboratory Coagulation of the Croatian Society of Medical Biochemistry and Laboratory Medicine

PubMed Central

Bronić, Ana; Herak, Desiree Coen; Margetić, Sandra; Milić, Marija

2017-01-01

Introduction The objective of this survey was to assess current policies and practice in haemostasis testing among both hospital and outpatient laboratories in Republic of Croatia. Materials and methods A questionnaire with seventy questions divided into nine sections was created in May 2015. Participants were asked about their practice related to test request form, sample collection, prothrombin time (PT) and activated partial thromboplastin time assays, other individual haemostasis assays, point-of-care testing (POCT), reporting of coagulation tests results and quality assurance of procedures, the personnel and other laboratory resources, as well as on issues related to education and implementation of additional coagulation assays in their laboratory. The survey was administered and data were collected between June and September 2015. Results A total survey response rate was 104/170 (61.2%). Most respondents were faced with incomplete information on prescribed therapy and diagnosis on the test request or inappropriate samples withdrawn on distant locations, but also do not have protocols for handling samples with high haematocrit values. Reporting of PT-INR and D-dimer results was different between laboratories. Although almost all laboratories developed a critical value reporting system, reporting a value to general practitioners is still a problem. Result on coagulation POCT testing showed that not all devices were supervised by laboratories, which is not in compliance with Croatian Chamber of Medical Biochemistry acts. Conclusion Obtained results highlighted areas that need improvement and different practice patterns in particular field of haemostasis testing among laboratories. A harmonization of the overall process of haemostasis testing at national level should be considered and undertaken. PMID:28392741

Integrated Data Collection Analysis (IDCA) program--KClO 4/Dodecane Mixture

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

Sandstrom, Mary M.; Brown, Geoffrey W.; Preston, Daniel N.

The Integrated Data Collection Analysis (IDCA) program is conducting a proficiency study for Small- Scale Safety and Thermal (SSST) testing of homemade explosives (HMEs). Described here are the results for impact, friction, electrostatic discharge, and differential scanning calorimetry analysis of a mixture of KClO 4 and dodecane—KClO 4/dodecane mixture. This material was selected because of the challenge of performing SSST testing of a mixture of solid and liquid materials. The mixture was found to: 1) be less sensitive to impact than RDX, and PETN, 2) less sensitive to friction than RDX and PETN, and 3) less sensitive to spark thanmore » RDX and PETN. The thermal analysis showed little or no exothermic features suggesting that the dodecane volatilized at low temperatures. A prominent endothermic feature was observed and assigned to a phase transition of KClO 4. This effort, funded by the Department of Homeland Security (DHS), ultimately will put the issues of safe handling of these materials in perspective with standard military explosives. The study is adding SSST testing results for a broad suite of different HMEs to the literature. Ultimately the study has the potential to suggest new guidelines and methods and possibly establish the SSST testing accuracies needed to develop safe handling practices for HMEs. Each participating testing laboratory uses identical test materials and preparation methods wherever possible. Note, however, the test procedures differ among the laboratories. The results are compared among the laboratories and then compared to historical data from various sources. The testing performers involved for the KClO 4/dodecane mixture are Lawrence Livermore National Laboratory (LLNL), Los Alamos National Laboratory (LANL), Indian Head Division, Naval Surface Warfare Center, (NSWC IHD), and Air Force Research Laboratory (AFRL/RXQL). These tests are conducted as a proficiency study in order to establish some consistency in test protocols, procedures, and experiments and to understand how to compare results when these testing variables cannot be made consistent.« less

Survey of laboratory practices for diagnosis of fungal infection in seven Asian countries: An Asia Fungal Working Group (AFWG) initiative.

PubMed

Chindamporn, Ariya; Chakrabarti, Arunaloke; Li, Ruoyu; Sun, Pei-Lun; Tan, Ban-Hock; Chua, Mitzi; Wahyuningsih, Retno; Patel, Atul; Liu, Zhengyin; Chen, Yee-Chun; Chayakulkeeree, Methee

2018-06-01

An online survey of mycology laboratories in seven Asian countries was conducted to assess the status, competence, and services available. Country representatives from the Asia Fungal Working Group (AFWG) contacted as many laboratories performing mycology diagnosis as possible in their respective countries, requesting that the laboratory heads complete the online survey. In total, 241 laboratories responded, including 71 in China, 104 in India, 11 in Indonesia, 26 in the Philippines, four in Singapore, 18 in Taiwan, and seven in Thailand. Overall, 129/241 (53.5%) surveyed mycology laboratories operate as separate designated mycology laboratories, 75/241 (31.1%) conduct regular formal staff training, 103/241 (42.7%) are accredited, and 88/157 (56.1%) participate in external quality assurance scheme (EQAS) programs. Microscopy and culture methods are available in nearly all laboratories, although few perform DNA sequencing (37/219; 16.9%) or use matrix-assisted laser desorption/ionization time-of-flight mass spectroscopy (MALDI-TOF MS) (27/219; 12.3%) for isolate identification. Antifungal susceptibility testing is performed in 142/241 (58.9%) laboratories, mainly for yeasts. The most commonly performed nonculture diagnostic is cryptococcal antigen testing (66 laboratories), followed by galactomannan testing (55), polymerase chain reaction (PCR) diagnosis (37), and beta-D-glucan testing (24). Therapeutic drug monitoring is conducted in 21 laboratories. There is almost no access to advanced diagnostic tests, like galactomannan, β-D-glucan, and PCR, in the surveyed laboratories in Indonesia, the Philippines, and Thailand. These results highlight the need for development of quality laboratories, accreditation and training of manpower in existing laboratories, and access to advanced non-culture-based diagnostic tests to facilitate the diagnosis of fungal infections in Asia.

Guidance for laboratories performing molecular pathology for cancer patients

PubMed Central

Cree, Ian A; Deans, Zandra; Ligtenberg, Marjolijn J L; Normanno, Nicola; Edsjö, Anders; Rouleau, Etienne; Solé, Francesc; Thunnissen, Erik; Timens, Wim; Schuuring, Ed; Dequeker, Elisabeth; Murray, Samuel; Dietel, Manfred; Groenen, Patricia; Van Krieken, J Han

2014-01-01

Molecular testing is becoming an important part of the diagnosis of any patient with cancer. The challenge to laboratories is to meet this need, using reliable methods and processes to ensure that patients receive a timely and accurate report on which their treatment will be based. The aim of this paper is to provide minimum requirements for the management of molecular pathology laboratories. This general guidance should be augmented by the specific guidance available for different tumour types and tests. Preanalytical considerations are important, and careful consideration of the way in which specimens are obtained and reach the laboratory is necessary. Sample receipt and handling follow standard operating procedures, but some alterations may be necessary if molecular testing is to be performed, for instance to control tissue fixation. DNA and RNA extraction can be standardised and should be checked for quality and quantity of output on a regular basis. The choice of analytical method(s) depends on clinical requirements, desired turnaround time, and expertise available. Internal quality control, regular internal audit of the whole testing process, laboratory accreditation, and continual participation in external quality assessment schemes are prerequisites for delivery of a reliable service. A molecular pathology report should accurately convey the information the clinician needs to treat the patient with sufficient information to allow for correct interpretation of the result. Molecular pathology is developing rapidly, and further detailed evidence-based recommendations are required for many of the topics covered here. PMID:25012948

Cell-Free DNA Analysis in Maternal Blood: Differences in Estimates between Laboratories with Different Methodologies Using a Propensity Score Approach.

PubMed

Bevilacqua, Elisa; Jani, Jacques C; Letourneau, Alexandra; Duiella, Silvia F; Kleinfinger, Pascale; Lohmann, Laurence; Resta, Serena; Cos Sanchez, Teresa; Fils, Jean-François; Mirra, Marilyn; Benachi, Alexandra; Costa, Jean-Marc

2018-06-13

To evaluate the failure rate and performance of cell-free DNA (cfDNA) testing, mainly in terms of detection rates for trisomy 21, performed by 2 laboratories using different analytical methods. cfDNA testing was performed on 2,870 pregnancies with the HarmonyTM Prenatal Test using the targeted digital analysis of selected regions (DANSR) method, and on 2,635 pregnancies with the "Cerba test" using the genome-wide massively parallel sequencing (GW-MPS) method, with available outcomes. Propensity score analysis was used to match patients between the 2 groups. A comparison of the detection rates for trisomy 21 between the 2 laboratories was made. In all, 2,811 patients in the Harmony group and 2,530 patients in the Cerba group had no trisomy 21, 18, or 13. Postmatched comparisons of the patient characteristics indicated a higher no-result rate in the Harmony group (1.30%) than in the Cerba group (0.75%; p = 0.039). All 41 cases of trisomy 21 in the Harmony group and 93 cases in the Cerba group were detected. Both methods of cfDNA testing showed low no-result rates and a comparable performance in detecting trisomy 21; yet GW-MPS had a slightly lower no-result rate than the DANSR method. © 2018 S. Karger AG, Basel.

Use of a hand-held meter for detecting subclinical ketosis in dairy cows.

PubMed

Voyvoda, Huseyin; Erdogan, Hasan

2010-12-01

The Optium Xceed is a new hand-held meter for determining blood β-hydroxybutyrate (BHBA) and glucose in human medicine. The objective of this study was to compare BHBA and glucose results obtained using the hand-held meter with those results made with a laboratory method and to evaluate its usefulness as a cowside test in the diagnosis of subclinical ketosis (SCK) in dairy cows. Seventy-eight blood samples from clinically healthy Holstein cows between 5 and 60 days post-calving were analysed. BHBA and glucose values were significantly higher with the hand-held meter versus laboratory methods. Correlation coefficients (r) for BHBA and glucose with the Optium Xceed versus laboratory methods were 0.97 and 0.63, respectively. Based on Bland-Altman plot and Passing-Bablok regression, agreement between two methods was good for BHBA but the agreement for glucose was only fair. When SCK was defined as plasma BHBA levels ≥ 1200 μmol/L, the sensitivity and specificity of the hand-held meter ketone testing in determining SCK were 85% and 94%, respectively. Raising the threshold of the laboratory method to ≥ 1400 μmol/L, the sensitivity and specificity incremented to 0.90 and 0.98, respectively. In conclusion, the blood ketone-monitoring device can be used as a rapid and reliable diagnostic test to detect SCK under field conditions. Copyright © 2010 Elsevier Ltd. All rights reserved.

Portuguese Family Physicians’ Awareness of Diagnostic and Laboratory Test Costs: A Cross-Sectional Study

PubMed Central

Sá, Luísa; Costa-Santos, Cristina; Teixeira, Andreia; Couto, Luciana; Costa-Pereira, Altamiro; Hespanhol, Alberto; Santos, Paulo; Martins, Carlos

2015-01-01

Background Physicians’ ability to make cost-effective decisions has been shown to be affected by their knowledge of health care costs. This study assessed whether Portuguese family physicians are aware of the costs of the most frequently prescribed diagnostic and laboratory tests. Methods A cross-sectional study was conducted in a representative sample of Portuguese family physicians, using computer-assisted telephone interviews for data collection. A Likert scale was used to assess physician’s level of agreement with four statements about health care costs. Family physicians were also asked to estimate the costs of diagnostic and laboratory tests. Each physician’s cost estimate was compared with the true cost and the absolute error was calculated. Results One-quarter (24%; 95% confidence interval: 23%–25%) of all cost estimates were accurate to within 25% of the true cost, with 55% (95% IC: 53–56) overestimating and 21% (95% IC: 20–22) underestimating the true actual cost. The majority (76%) of family physicians thought they did not have or were uncertain as to whether they had adequate knowledge of diagnostic and laboratory test costs, and only 7% reported receiving adequate education. The majority of the family physicians (82%) said that they had adequate access to information about the diagnostic and laboratory test costs. Thirty-three percent thought that costs did not influence their decision to order tests, while 27% were uncertain. Conclusions Portuguese family physicians have limited awareness of diagnostic and laboratory test costs, and our results demonstrate a need for improved education in this area. Further research should focus on identifying whether interventions in cost knowledge actually change ordering behavior, in identifying optimal methods to disseminate cost information, and on improving the cost-effectiveness of care. PMID:26356625

Antimicrobial susceptibility testing by Australian veterinary diagnostic laboratories.

PubMed

Hardefeldt, L Y; Marenda, M; Crabb, H; Stevenson, M A; Gilkerson, J R; Billman-Jacobe, H; Browning, G F

2018-04-01

The national strategy for tackling antimicrobial resistance highlights the need for antimicrobial stewardship in veterinary practice and for surveillance of antimicrobial susceptibility in veterinary pathogens. Diagnostic laboratories have an important role in facilitating both of these processes, but it is unclear whether data from veterinary diagnostic laboratories are similar enough to allow for compilation and if there is consistent promotion of appropriate antimicrobial use embedded in the approaches of different laboratories to susceptibility testing. A cross-sectional study of antimicrobial susceptibility testing and reporting procedures by Australian veterinary diagnostic laboratories was conducted in 2017 using an online questionnaire. All 18 veterinary diagnostic laboratories in Australia completed the questionnaire. Kirby-Bauer disc diffusion was the method predominantly used for antimicrobial susceptibility testing and was used to evaluate 86% of all isolates, although two different protocols were used across the 18 laboratories (CLSI 15/18, CDS 3/18). Minimum inhibitory concentrations were never reported by 61% of laboratories. Common isolates were consistently reported on across all species, except for gram-negative isolates in pigs, for which there was some variation in the approach to reporting. There was considerable diversity in the panels of antimicrobials used for susceptibility testing on common isolates and no consistency was apparent between laboratories for any bacterial species. We recommend that nationally agreed and consistent antimicrobial panels for routine susceptibility testing should be developed and a uniform set of guidelines should be adopted by veterinary diagnostic laboratories in Australia. © 2018 Australian Veterinary Association.

Experimental Protocol to Determine the Chloride Threshold Value for Corrosion in Samples Taken from Reinforced Concrete Structures

PubMed Central

Angst, Ueli M.; Boschmann, Carolina; Wagner, Matthias; Elsener, Bernhard

2017-01-01

The aging of reinforced concrete infrastructure in developed countries imposes an urgent need for methods to reliably assess the condition of these structures. Corrosion of the embedded reinforcing steel is the most frequent cause for degradation. While it is well known that the ability of a structure to withstand corrosion depends strongly on factors such as the materials used or the age, it is common practice to rely on threshold values stipulated in standards or textbooks. These threshold values for corrosion initiation (Ccrit) are independent of the actual properties of a certain structure, which clearly limits the accuracy of condition assessments and service life predictions. The practice of using tabulated values can be traced to the lack of reliable methods to determine Ccrit on-site and in the laboratory. Here, an experimental protocol to determine Ccrit for individual engineering structures or structural members is presented. A number of reinforced concrete samples are taken from structures and laboratory corrosion testing is performed. The main advantage of this method is that it ensures real conditions concerning parameters that are well known to greatly influence Ccrit, such as the steel-concrete interface, which cannot be representatively mimicked in laboratory-produced samples. At the same time, the accelerated corrosion test in the laboratory permits the reliable determination of Ccrit prior to corrosion initiation on the tested structure; this is a major advantage over all common condition assessment methods that only permit estimating the conditions for corrosion after initiation, i.e., when the structure is already damaged. The protocol yields the statistical distribution of Ccrit for the tested structure. This serves as a basis for probabilistic prediction models for the remaining time to corrosion, which is needed for maintenance planning. This method can potentially be used in material testing of civil infrastructures, similar to established methods used for mechanical testing. PMID:28892023

Experimental Protocol to Determine the Chloride Threshold Value for Corrosion in Samples Taken from Reinforced Concrete Structures.

PubMed

Angst, Ueli M; Boschmann, Carolina; Wagner, Matthias; Elsener, Bernhard

2017-08-31

The aging of reinforced concrete infrastructure in developed countries imposes an urgent need for methods to reliably assess the condition of these structures. Corrosion of the embedded reinforcing steel is the most frequent cause for degradation. While it is well known that the ability of a structure to withstand corrosion depends strongly on factors such as the materials used or the age, it is common practice to rely on threshold values stipulated in standards or textbooks. These threshold values for corrosion initiation (Ccrit) are independent of the actual properties of a certain structure, which clearly limits the accuracy of condition assessments and service life predictions. The practice of using tabulated values can be traced to the lack of reliable methods to determine Ccrit on-site and in the laboratory. Here, an experimental protocol to determine Ccrit for individual engineering structures or structural members is presented. A number of reinforced concrete samples are taken from structures and laboratory corrosion testing is performed. The main advantage of this method is that it ensures real conditions concerning parameters that are well known to greatly influence Ccrit, such as the steel-concrete interface, which cannot be representatively mimicked in laboratory-produced samples. At the same time, the accelerated corrosion test in the laboratory permits the reliable determination of Ccrit prior to corrosion initiation on the tested structure; this is a major advantage over all common condition assessment methods that only permit estimating the conditions for corrosion after initiation, i.e., when the structure is already damaged. The protocol yields the statistical distribution of Ccrit for the tested structure. This serves as a basis for probabilistic prediction models for the remaining time to corrosion, which is needed for maintenance planning. This method can potentially be used in material testing of civil infrastructures, similar to established methods used for mechanical testing.

7 CFR 90.102 - Quality assurance review.

Code of Federal Regulations, 2011 CFR

2011-01-01

... INTRODUCTION Quality Assurance § 90.102 Quality assurance review. (a) Each laboratory performing tests and... review of the adequacy of quality control measures taken by the laboratory for the standardized method of...

7 CFR 90.102 - Quality assurance review.

Code of Federal Regulations, 2012 CFR

2012-01-01

... INTRODUCTION Quality Assurance § 90.102 Quality assurance review. (a) Each laboratory performing tests and... review of the adequacy of quality control measures taken by the laboratory for the standardized method of...

7 CFR 90.102 - Quality assurance review.

Code of Federal Regulations, 2013 CFR

2013-01-01

... INTRODUCTION Quality Assurance § 90.102 Quality assurance review. (a) Each laboratory performing tests and... review of the adequacy of quality control measures taken by the laboratory for the standardized method of...

7 CFR 90.102 - Quality assurance review.

Code of Federal Regulations, 2014 CFR

2014-01-01

... INTRODUCTION Quality Assurance § 90.102 Quality assurance review. (a) Each laboratory performing tests and... review of the adequacy of quality control measures taken by the laboratory for the standardized method of...

Develop a new testing and evaluation protocol to assess flexbase performance using strength of soil binder.

DOT National Transportation Integrated Search

2008-01-01

This research involved a detailed laboratory study of a new test method for evaluating road base materials based on : the strength of the soil binder. In this test method, small test specimens (5.0in length and 0.75in square cross : section) of binde...

HCG blood test - qualitative

MedlinePlus

... pregnancy. Other HCG tests include: HCG urine test Quantitative pregnancy test (checks specific level of HCG in ... eds. Henry's Clinical Diagnosis and Management by Laboratory Methods . 23rd ed. Philadelphia, PA: Elsevier; 2017:chap 74. ...

[Building and implementation of management system in laboratories of the National Institute of Hygiene].

PubMed

Rozbicka, Beata; Brulińska-Ostrowska, Elzbieta

2008-01-01

The rules of good laboratory practice have always been observed in the laboratories of National Institute of Hygiene (NIH) and the reliability of the results has been carefully cared after when performing tests for clients. In 2003 the laboratories performing analyses related to food safety were designated as the national reference laboratories. This, added to the necessity of compliance with work standards and requirements of EU legislation and to the need of confirmation of competence by an independent organisation, led to a decision to seek accreditation of Polish Centre of Accreditation (PCA). The following stages of building and implementation of management system were presented: training, modifications of Institute's organisational structure, elaboration of management system's documentation, renovation and refurbishment of laboratory facilities, implementation of measuring and test equipment's supervision, internal audits and management review. The importance of earlier experiences and achievements with regard to validation of analytical methods and guarding of the quality of the results through organisation and participation in proficiency tests was highlighted. Current status of accreditation of testing procedures used in NIH laboratories that perform analyses in the field of chemistry, microbiology, radiobiology and medical diagnostic tests was presented.

Repeatability and Reproducibility of Compression Strength Measurements Conducted According to ASTM E9

NASA Technical Reports Server (NTRS)

Luecke, William E.; Ma, Li; Graham, Stephen M.; Adler, Matthew A.

2010-01-01

Ten commercial laboratories participated in an interlaboratory study to establish the repeatability and reproducibility of compression strength tests conducted according to ASTM International Standard Test Method E9. The test employed a cylindrical aluminum AA2024-T351 test specimen. Participants measured elastic modulus and 0.2 % offset yield strength, YS(0.2 % offset), using an extensometer attached to the specimen. The repeatability and reproducibility of the yield strength measurement, expressed as coefficient of variations were cv(sub r)= 0.011 and cv(sub R)= 0.020 The reproducibility of the test across the laboratories was among the best that has been reported for uniaxial tests. The reported data indicated that using diametrically opposed extensometers, instead of a single extensometer doubled the precision of the test method. Laboratories that did not lubricate the ends of the specimen measured yield stresses and elastic moduli that were smaller than those measured in laboratories that lubricated the specimen ends. A finite element analysis of the test specimen deformation for frictionless and perfect friction could not explain the discrepancy, however. The modulus measured from stress-strain data were reanalyzed using a technique that finds the optimal fit range, and applies several quality checks to the data. The error in modulus measurements from stress-strain curves generally increased as the fit range decreased to less than 40 % of the stress range.

21 CFR 118.8 - Testing methodology for Salmonella Enteritidis (SE).

Code of Federal Regulations, 2010 CFR

2010-04-01

... Salmonella Web site is located at http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/ucm114716.htm... you may examine a copy at the Center for Food Safety and Applied Nutrition's Library, 5100 Paint... Edition, is located at http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalytical...

Agreement between clinical and laboratory methods assessing tonic and cross-link components of accommodation and vergence.

PubMed

Neveu, Pascaline; Priot, Anne-Emmanuelle; Philippe, Matthieu; Fuchs, Philippe; Roumes, Corinne

2015-09-01

Several tests are available to optometrists for investigating accommodation and vergence. This study sought to investigate the agreement between clinical and laboratory methods and to clarify which components are actually measured when tonic and cross-link of accommodation and vergence are assessed. Tonic vergence, tonic accommodation, accommodative vergence (AC/A) and vergence accommodation (CA/C) were measured using several tests. Clinical tests were compared to the laboratory assessment, the latter being regarded as an absolute reference. The repeatability of each test and the degree of agreement between the tests were quantified using Bland-Altman analysis. The values obtained for each test were found to be stable across repetitions; however, in most cases, significant differences were observed between tests supposed to measure the same oculomotor component. Tonic and cross-link components cannot be easily assessed because proximal and instrumental responses interfere with the assessment. Other components interfere with oculomotor assessment. Specifically, accommodative divergence interferes with tonic vergence estimation and the type of accommodation considered in the AC/A ratio affects its magnitude. Results on clinical tonic accommodation and clinical CA/C show that further investigation is needed to clarify the limitations associated with the use of difference of Gaussian as visual targets to open the accommodative loop. Although different optometric tests of accommodation and vergence rely on the same basic principles, the results of this study indicate that clinical and laboratory methods actually involve distinct components. These differences, which are induced by methodological choices, must be taken into account, when comparing studies or when selecting a test to investigate a particular oculomotor component. © 2015 The Authors. Clinical and Experimental Optometry © 2015 Optometry Australia.

Frederick National Laboratory Rallies to Meet Demand for Zika Vaccine | Frederick National Laboratory for Cancer Research

Cancer.gov

The Frederick National Laboratory for Cancer Research is producing another round of Zika vaccine for ongoing studies to determine the best delivery method and dosage. This will lay the groundwork for additional tests to see if the vaccine prevents i

Verification of examination procedures in clinical laboratory for imprecision, trueness and diagnostic accuracy according to ISO 15189:2012: a pragmatic approach.

PubMed

Antonelli, Giorgia; Padoan, Andrea; Aita, Ada; Sciacovelli, Laura; Plebani, Mario

2017-08-28

Background The International Standard ISO 15189 is recognized as a valuable guide in ensuring high quality clinical laboratory services and promoting the harmonization of accreditation programmes in laboratory medicine. Examination procedures must be verified in order to guarantee that their performance characteristics are congruent with the intended scope of the test. The aim of the present study was to propose a practice model for implementing procedures employed for the verification of validated examination procedures already used for at least 2 years in our laboratory, in agreement with the ISO 15189 requirement at the Section 5.5.1.2. Methods In order to identify the operative procedure to be used, approved documents were identified, together with the definition of performance characteristics to be evaluated for the different methods; the examination procedures used in laboratory were analyzed and checked for performance specifications reported by manufacturers. Then, operative flow charts were identified to compare the laboratory performance characteristics with those declared by manufacturers. Results The choice of performance characteristics for verification was based on approved documents used as guidance, and the specific purpose tests undertaken, a consideration being made of: imprecision and trueness for quantitative methods; diagnostic accuracy for qualitative methods; imprecision together with diagnostic accuracy for semi-quantitative methods. Conclusions The described approach, balancing technological possibilities, risks and costs and assuring the compliance of the fundamental component of result accuracy, appears promising as an easily applicable and flexible procedure helping laboratories to comply with the ISO 15189 requirements.

Interlaboratory Study of Quality Control Isolates for a Broth Microdilution Method (Modified CLSI M38-A) for Testing Susceptibilities of Dermatophytes to Antifungals▿

PubMed Central

Ghannoum, M. A.; Arthington-Skaggs, B.; Chaturvedi, V.; Espinel-Ingroff, A.; Pfaller, M. A.; Rennie, R.; Rinaldi, M. G.; Walsh, T. J.

2006-01-01

The Clinical and Laboratory Standards Institute (CLSI; formerly National Committee for Clinical Laboratory Standards, or NCCLS) M38-A standard for the susceptibility testing of filamentous fungi does not specifically address the testing of dermatophytes. In 2003, a multicenter study investigated the reproducibility of the microdilution method developed at the Center for Medical Mycology, Cleveland, Ohio, for testing the susceptibility of dermatophytes. Data from that study supported the introduction of this method for testing dermatophytes in the future version of the CLSI M38-A standard. In order for the method to be accepted by CLSI, appropriate quality control isolates needed to be identified. To that end, an interlaboratory study, involving the original six laboratories plus two additional sites, was conducted to evaluate potential candidates for quality control isolates. These candidate strains included five Trichophyton rubrum strains known to have elevated MICs to terbinafine and five Trichophyton mentagrophytes strains. Antifungal agents tested included ciclopirox, fluconazole, griseofulvin, itraconazole, posaconazole, terbinafine, and voriconazole. Based on the data generated, two quality control isolates, one T. rubrum isolate and one T. mentagrophytes isolate, were identified and submitted to the American Type Culture Collection (ATCC) for inclusion as reference strains. Ranges encompassing 95.2 to 97.9% of all data points for all seven drugs were established. PMID:17050812

High-temperature acoustic test facilities and methods

NASA Astrophysics Data System (ADS)

Pearson, Jerome

1994-09-01

The Wright Laboratory is the Air Force center for air vehicles, responsible for developing advanced technology and incorporating it into new flight vehicles and for continuous technological improvement of operational air vehicles. Part of that responsibility is the problem of acoustic fatigue. With the advent of jet aircraft in the 1950's, acoustic fatigue of aircraft structure became a significant problem. In the 1960's the Wright Laboratory constructed the first large acoustic fatigue test facilities in the United States, and the laboratory has been a dominant factor in high-intensity acoustic testing since that time. This paper discusses some of the intense environments encountered by new and planned Air Force flight vehicles, and describes three new acoustic test facilities of the Wright Laboratory designed for testing structures in these dynamic environments. These new test facilities represent the state of the art in high-temperature, high-intensity acoustic testing and random fatigue testing. They will allow the laboratory scientists and engineers to test the new structures and materials required to withstand the severe environments of captive-carry missiles, augmented lift wings and flaps, exhaust structures of stealth aircraft, and hypersonic vehicle structures well into the twenty-first century.

External quality assessment unravels interlaboratory differences in quality of RAS testing for anti-EGFR therapy in colorectal cancer.

PubMed

Tack, Véronique; Ligtenberg, Marjolijn J L; Tembuyser, Lien; Normanno, Nicola; Vander Borght, Sara; Han van Krieken, J; Dequeker, Elisabeth M C

2015-03-01

Regulations for the selection of patients with metastatic colorectal cancer for anti-EGFR treatment changed at the end of 2013. The set of mutations to be tested extended from KRAS codons 12 and 13 to KRAS and NRAS exons 2, 3, and 4. A European external quality assessment scheme monitored the performance of laboratories and evaluated the implementation of the new regulations. The 131 participating laboratories received 10 samples of formalin-fixed paraffin-embedded material, including RAS (exon 2, 3, 4) and BRAF mutations. Mock clinical data were provided for three cases. Using their routine methods, laboratories determined the genotypes and submitted three written reports. Assessors scored the results according to predefined evaluation criteria. Half of the participants (49.3%) had completely implemented the new test requirements (codons 12, 13, 59, 61, 117, and 146 of KRAS and NRAS), and 96 laboratories (73.3%) made no genotype mistakes. Correct nomenclature, according to the Human Genome Variation Society, was used by 82 laboratories (62.6%). Although regulations were effective for several months, many laboratories were not ready for full RAS testing in the context of anti-EGFR therapy. Nevertheless, in each participating country, there are laboratories that provide complete and correct testing. External quality assessments can be used to monitor implementation of new test regulations and to stimulate the laboratories to improve their testing procedures. Because the results of this program are available on the website of the European Society of Pathology, patients and clinicians can refer test samples to a reliable laboratory. ©AlphaMed Press.

HLA-B27 antigen

MedlinePlus

... eds. Laboratory Tests and Diagnostic Procedures . 6th ed. St Louis, MO: Elsevier Saunders; 2013:654-655. Fagoaga ... Diagnosis and Management by Laboratory Methods . 23rd ed. St Louis, MO: Elsevier; 2017:chap 49. Inman RD. ...

Assuring the Quality of Test Results in the Field of Nuclear Techniques and Ionizing Radiation. The Practical Implementation of Section 5.9 of the EN ISO/IEC 17025 Standard

NASA Astrophysics Data System (ADS)

Cucu, Daniela; Woods, Mike

2008-08-01

The paper aims to present a practical approach for testing laboratories to ensure the quality of their test results. It is based on the experience gained in assessing a large number of testing laboratories, discussing with management and staff, reviewing results obtained in national and international PTs and ILCs and exchanging information in the EA laboratory committee. According to EN ISO/IEC 17025, an accredited laboratory has to implement a programme to ensure the quality of its test results for each measurand. Pre-analytical, analytical and post-analytical measures shall be applied in a systematic manner. They shall include both quality control and quality assurance measures. When designing the quality assurance programme a laboratory should consider pre-analytical activities (like personnel training, selection and validation of test methods, qualifying equipment), analytical activities ranging from sampling, sample preparation, instrumental analysis and post-analytical activities (like decoding, calculation, use of statistical tests or packages, management of results). Designed on different levels (analyst, quality manager and technical manager), including a variety of measures, the programme shall ensure the validity and accuracy of test results, the adequacy of the management system, prove the laboratory's competence in performing tests under accreditation and last but not least show the comparability of test results. Laboratory management should establish performance targets and review periodically QC/QA results against them, implementing appropriate measures in case of non-compliance.

A new LAMP-based assay for the molecular diagnosis of toxoplasmosis: comparison with a proficient PCR assay.

PubMed

Varlet-Marie, Emmanuelle; Sterkers, Yvon; Perrotte, Marina; Bastien, Patrick

2018-05-01

Toxoplasmosis is generally a benign infection caused by the protozoan parasite Toxoplasma gondii but can have severe consequences in fetuses of mothers infected during pregnancy (congenital toxoplasmosis) and immunocompromised individuals. PCR-based diagnostic tests have become crucial for its diagnosis. However, this molecular diagnosis essentially relies upon laboratory-developed methods and suffers from a lack of standardization, leading to great variation in methods and performance among laboratories. With the need for accreditation of clinical microbiological laboratories, the use of commercial PCR kits has become an attractive alternative; but thorough evaluation of newly commercialized kits by proficient groups is necessary before any recommendation can be made to parasitology laboratories by health authorities or learned societies. Here, we compared the performance of an original commercial method, the Iam TOXO Q-LAMP (DiaSorin®), using Loop-mediated isothermal amplification (LAMP) technology, with our reference laboratory-developed method using real-time PCR. The kit was first tested using amniotic fluid (AF) and plasma samples (either negative or spiked with live T. gondii tachyzoites at different concentrations (from 7 to 10 5  tachyzoites/mL)). It was then assessed using a cohort of 11 AF, five placental and 32 blood clinical samples preserved at -20 °C. For the processing of placental/blood samples, a pretreatment step was used, which did not strictly follow the manufacturer's recommendations. The practical ease of use and compliance with good laboratory practices were also evaluated. Although the LAMP assay was less sensitive than the laboratory-developed method at very low parasite concentrations (0.1 T. gondii genome equivalents/mL), the two methods yielded identical results qualitatively and, in some instances, quantitatively, particularly for AF samples. Copyright © 2018. Published by Elsevier Ltd.

A multilaboratory peer assessment quality assurance program-based evaluation of anticardiolipin antibody, and beta2-glycoprotein I antibody testing.

PubMed

Favaloro, Emmanuel J; Wong, Richard C W; Silvestrini, Roger; McEvoy, Robert; Jovanovich, Susan; Roberts-Thomson, Peter

2005-02-01

We evaluated the performance of anticardiolipin (aCL) and beta2-glycoprotein I (beta2-GPI) antibody assays through a large external quality assurance program. Data from the 2002 cycle of the Royal College of Pathologists of Australasia Quality Assurance Program (RCPA QAP) were analyzed for variation in reported numerical values and semiquantitative results or interpretations according to method type or group and in conjunction with available clinical data. High interlaboratory variation in numerical results and notable method-based variation, combined with a general lack of consensus in semiquantitative reporting, continues to be observed. Numerical results from cross-laboratory testing of 12 serum samples (for immunoglobulin G [IgG]-aCL, IgM-aCL, and IgG-beta2-GPI) yielded interlaboratory coefficients of variation (CVs) that were higher than 50% in six of 12 (50%) specimens for IgG-aCL, and 12 of 12 (100%) specimens for IgM-aCL and IgG-beta2-GPI. Semiquantitative reporting also varied considerably, with total (100%) consensus occurring in only four of 36 (11%) occasions. General consensus (where > 90% of participating laboratories agreed that a given serum sample gave a result of either negative or positive) was only obtained on 13 of 36 (36%) occasions. Variation in results between different method types or groups were also present, resulting in potential biasing of the RCPA QAP-defined target results by the large number of laboratories using the dominant aCL assays. Finally, laboratory findings frequently did not agree with the available clinical information. In conclusion, in a large proportion of specimens from the 2002 RCPA QAP cycle, laboratories could not agree on whether a serum sample tested was aCL-positive or aCL-negative, or beta2-GPI-positive or beta2-GPI-negative. Despite prior attempts to improve the standardization of testing and reporting practices, laboratory testing for aCL and anti-beta2-GPI still demonstrates significant interlaboratory and intermethod variation, which needs to be taken into account for the clinical interpretation of test results, especially those from different laboratories.

Kidney function tests

MedlinePlus

Kidney function tests are common lab tests used to evaluate how well the kidneys are working. Such tests include: ... Oh MS, Briefel G. Evaluation of renal function, water, electrolytes ... and Management by Laboratory Methods . 23rd ed. Philadelphia, ...

Reduction in in vivo testing at the National Veterinary Services Laboratories of the United States Department of Agriculture.

PubMed

Hyde, R L

1986-01-01

Efforts are being made at the National Veterinary Services Laboratories to reduce in vivo testing of USDA licensed veterinary vaccines. A hemagglutination test for determining potency of killed parvovirus vaccine is currently being used for canine and swine adjuvanted and nonadjuvanted products; a serum neutralization inhibition test (SNIT) is being developed for potency testing of killed adjuvanted infectious bovine rhinotracheitis (IBR), bovine virus diarrhea (BVD) and parainfluenza (PI3) vaccines: and a tissue culture titration method for live avian encephalomyelitis virus vaccine is being pursued as a replacement for the old hatch-out chick embryo titration method. Difficulties in separating the antigen from oil emulsion products are preventing significant advances in developing in vitro testing procedures for poultry killed-virus vaccines.

Automated cognitive testing of monkeys in social groups yields results comparable to individual laboratory-based testing.

PubMed

Gazes, Regina Paxton; Brown, Emily Kathryn; Basile, Benjamin M; Hampton, Robert R

2013-05-01

Cognitive abilities likely evolved in response to specific environmental and social challenges and are therefore expected to be specialized for the life history of each species. Specialized cognitive abilities may be most readily engaged under conditions that approximate the natural environment of the species being studied. While naturalistic environments might therefore have advantages over laboratory settings for cognitive research, it is difficult to conduct certain types of cognitive tests in these settings. We implemented methods for automated cognitive testing of monkeys (Macaca mulatta) in large social groups (Field station) and compared the performance to that of laboratory-housed monkeys (Laboratory). The Field station animals shared access to four touch-screen computers in a large naturalistic social group. Each Field station subject had an RFID chip implanted in each arm for computerized identification and individualized assignment of cognitive tests. The Laboratory group was housed and tested in a typical laboratory setting, with individual access to testing computers in their home cages. Monkeys in both groups voluntarily participated at their own pace for food rewards. We evaluated performance in two visual psychophysics tests, a perceptual classification test, a transitive inference test, and a delayed matching-to-sample memory test. Despite the differences in housing, social environment, age, and sex, monkeys in the two groups performed similarly in all tests. Semi-free ranging monkeys living in complex social environments are therefore viable subjects for cognitive testing designed to take advantage of the unique affordances of naturalistic testing environments.

Automated cognitive testing of monkeys in social groups yields results comparable to individual laboratory based testing

PubMed Central

Gazes, Regina Paxton; Brown, Emily Kathryn; Basile, Benjamin M.; Hampton, Robert R.

2013-01-01

Cognitive abilities likely evolved in response to specific environmental and social challenges and are therefore expected to be specialized for the life history of each species. Specialized cognitive abilities may be most readily engaged under conditions that approximate the natural environment of the species being studied. While naturalistic environments might therefore have advantages over laboratory settings for cognitive research, it is difficult to conduct certain types of cognitive tests in these settings. We implemented methods for automated cognitive testing of monkeys (Macaca mulatta) in large social groups (Field station) and compared the performance to that of laboratory housed monkeys (Laboratory). The Field station animals shared access to four touch screen computers in a large naturalistic social group. Each Field station subject had an RFID chip implanted in each arm for computerized identification and individualized assignment of cognitive tests. The Laboratory group was housed and tested in a typical laboratory setting, with individual access to testing computers in their home cages. Monkeys in both groups voluntarily participated at their own pace for food rewards. We evaluated performance in two visual psychophysics tests, a perceptual classification test, a transitive inference test, and a delayed matching to sample memory test. Despite differences in housing, social environment, age, and sex, monkeys in the two groups performed similarly in all tests. Semi-free ranging monkeys living in complex social environments are therefore viable subjects for cognitive testing designed to take advantage of the unique affordances of naturalistic testing environments. PMID:23263675

Development of fire test methods for airplane interior materials

NASA Technical Reports Server (NTRS)

Tustin, E. A.

1978-01-01

Fire tests were conducted in a 737 airplane fuselage at NASA-JSC to characterize jet fuel fires in open steel pans (simulating post-crash fire sources and a ruptured airplane fuselage) and to characterize fires in some common combustibles (simulating in-flight fire sources). Design post-crash and in-flight fire source selections were based on these data. Large panels of airplane interior materials were exposed to closely-controlled large scale heating simulations of the two design fire sources in a Boeing fire test facility utilizing a surplused 707 fuselage section. Small samples of the same airplane materials were tested by several laboratory fire test methods. Large scale and laboratory scale data were examined for correlative factors. Published data for dangerous hazard levels in a fire environment were used as the basis for developing a method to select the most desirable material where trade-offs in heat, smoke and gaseous toxicant evolution must be considered.

[Interlaboratory Study on Evaporation Residue Test for Food Contact Products (Report 2)].

PubMed

Ohno, Hiroyuki; Mutsuga, Motoh; Abe, Tomoyuki; Abe, Yutaka; Amano, Homare; Ishihara, Kinuyo; Ohsaka, Ikue; Ohno, Haruka; Ohno, Yuichiro; Ozaki, Asako; Kakihara, Yoshiteru; Kobayashi, Hisashi; Sakuragi, Hiroshi; Shibata, Hiroshi; Shirono, Katsuhiro; Sekido, Haruko; Takasaka, Noriko; Takenaka, Yu; Tajima, Yoshiyasu; Tanaka, Aoi; Tanaka, Hideyuki; Nakanishi, Toru; Nomura, Chie; Haneishi, Nahoko; Hayakawa, Masato; Miura, Toshihiko; Yamaguchi, Miku; Yamada, Kyohei; Watanabe, Kazunari; Sato, Kyoko

2018-01-01

An interlaboratory study was performed to evaluate the equivalence between an official method and a modified method of evaporation residue test using heptane as a food-simulating solvent for oily or fatty foods, based on the Japanese Food Sanitation Law for food contact products. Twenty-three laboratories participated, and tested the evaporation residues of nine test solutions as blind duplicates. In the official method, heating for evaporation was done with a water bath. In the modified method, a hot plate was used for evaporation, and/or a vacuum concentration procedure was skipped. In most laboratories, the test solutions were heated until just prior to dryness, and then allowed to dry under residual heat. Statistical analysis revealed that there was no significant difference between the two methods. Accordingly, the modified method provides performance equal to the official method, and is available as an alternative method. Furthermore, an interlaboratory study was performed to evaluate and compare two leaching solutions (95% ethanol and isooctane) used as food-simulating solvents for oily or fatty foods in the EU. The results demonstrated that there was no significant difference between heptane and these two leaching solutions.

Reducing Overutilization of Testing for Clostridium difficile Infection in a Pediatric Hospital System: A Quality Improvement Initiative.

PubMed

Klatte, J Michael; Selvarangan, Rangaraj; Jackson, Mary Anne; Myers, Angela L

2016-01-01

Study objectives included addressing overuse of Clostridium difficile laboratory testing by decreasing submission rates of nondiarrheal stool specimens and specimens from children ≤12 months of age and determining resultant patient and laboratory cost savings associated with decreased testing. A multifaceted initiative was developed, and components included multiple provider education methods, computerized order entry modifications, and automatic declination from laboratory on testing stool specimens of nondiarrheal consistency and from children ≤12 months old. A run chart, demonstrating numbers of nondiarrheal plus infant stool specimens submitted over time, was developed to analyze the initiative's impact on clinicians' test-ordering practices. A p-chart was generated to evaluate the percentage of these submitted specimens tested biweekly over a 12-month period. Cost savings for patients and the laboratory were assessed at the study period's conclusion. Run chart analysis revealed an initial shift after the interventions, suggesting a temporary decrease in testing submission; however, no sustained differences in numbers of specimens submitted biweekly were observed over time. On the p-chart, the mean percentage of specimens tested before the intervention was 100%. After the intervention, the average percentage of specimens tested dropped to 53.8%. Resultant laboratory cost savings totaled nearly $3600, and patient savings on testing charges were ∼$32 000. Automatic laboratory declination of nondiarrheal stools submitted for CDI testing resulted in a sustained decrease in the number of specimens tested, resulting in significant laboratory and patient cost savings. Despite multiple educational efforts, no sustained changes in physician ordering practices were observed. Copyright © 2016 by the American Academy of Pediatrics.

HPLC and LC-MS/MS methods for determination of sodium benzoate and potassium sorbate in food and beverages: performances of local accredited laboratories via proficiency tests in Turkey.

PubMed

Gören, Ahmet C; Bilsel, Gökhan; Şimşek, Adnan; Bilsel, Mine; Akçadağ, Fatma; Topal, Kevser; Ozgen, Hasan

2015-05-15

High Performance Liquid Chromatography LC-UV and LC-MS/MS methods were developed and validated for quantitative analyses of sodium benzoate and potassium sorbate in foods and beverages. HPLC-UV and LC-MS/MS methods were compared for quantitative analyses of sodium benzoate and potassium sorbate in a representative ketchup sample. Optimisation of the methods enabled the chromatographic separation of the analytes in less than 4 min. A correlation coefficient of 0.999 was achieved over the measured calibration range for both compounds and methods (HPLC and LC-MS/MS). The uncertainty values of sodium benzoate and potassium sorbate were found as 0.199 and 0.150 mg/L by HPLC and 0.072 and 0.044 mg/L by LC-MS/MS, respectively. Proficiency testing performance of Turkish accredited laboratories between the years 2005 and 2013 was evaluated and reported herein. The aim of the proficiency testing scheme was to evaluate the performance of the laboratories, analysing benzoate and sorbate in tomato ketchup. Copyright © 2014 Elsevier Ltd. All rights reserved.

Bridging naturalistic and laboratory assessment of memory: the Baycrest mask fit test.

PubMed

Armson, Michael J; Abdi, Hervé; Levine, Brian

2017-09-01

Autobiographical memory tests provide a naturalistic counterpoint to the artificiality of laboratory research methods, yet autobiographical events are uncontrolled and, in most cases, unverifiable. In this study, we capitalised on a scripted, complex naturalistic event - the mask fit test (MFT), a standardised procedure required of hospital employees - to bridge the gap between naturalistic and laboratory memory assessment. We created a test of recognition memory for the MFT and administered it to 135 hospital employees who had undertaken the MFT at various points over the past five years. Multivariate analysis revealed two dimensions defined by accuracy and response bias. Accuracy scores showed the expected relationship to encoding-test delay, supporting the validity of this measure. Relative to younger adults, older adults' memory for this naturalistic event was better than would be predicted from the cognitive ageing literature, a result consistent with the notion that older adults' memory performance is enhanced when stimuli are naturalistic and personally relevant. These results demonstrate that testing recognition memory for a scripted event is a viable method of studying autobiographical memory.

Multilaboratory evaluation of methods for detecting enteric viruses in soils.

PubMed Central

Hurst, C J; Schaub, S A; Sobsey, M D; Farrah, S R; Gerba, C P; Rose, J B; Goyal, S M; Larkin, E P; Sullivan, R; Tierney, J T

1991-01-01

Two candidate methods for the recovery and detection of viruses in soil were subjected to round robin comparative testing by members of the American Society for Testing and Materials D19:24:04:04 Subcommittee Task Group. Selection of the methods, designated "Berg" and "Goyal," was based on results of an initial screening which indicated that both met basic criteria considered essential by the task group. Both methods utilized beef extract solutions to achieve desorption and recovery of viruses from representative soils: a fine sand soil, an organic muck soil, a sandy loam soil, and a clay loam soil. One of the two methods, Goyal, also used a secondary concentration of resulting soil eluants via low-pH organic flocculation to achieve a smaller final assay volume. Evaluation of the two methods was simultaneously performed in replicate by nine different laboratories. Each of the produced samples was divided into portions, and these were respectively subjected to quantitative viral plaque assay by both the individual, termed independent, laboratory which had done the soil processing and a single common reference laboratory, using a single cell line and passage level. The Berg method seemed to produce slightly higher virus recovery values; however, the differences in virus assay titers for samples produced by the two methods were not statistically significant (P less than or equal to 0.05) for any one of the four soils. Despite this lack of a method effect, there was a statistically significant laboratory effect exhibited by assay titers from the independent versus reference laboratories for two of the soils, sandy loam and clay loam. PMID:1849712

Multilaboratory evaluation of methods for detecting enteric viruses in soils.

PubMed

Hurst, C J; Schaub, S A; Sobsey, M D; Farrah, S R; Gerba, C P; Rose, J B; Goyal, S M; Larkin, E P; Sullivan, R; Tierney, J T

1991-02-01

Two candidate methods for the recovery and detection of viruses in soil were subjected to round robin comparative testing by members of the American Society for Testing and Materials D19:24:04:04 Subcommittee Task Group. Selection of the methods, designated "Berg" and "Goyal," was based on results of an initial screening which indicated that both met basic criteria considered essential by the task group. Both methods utilized beef extract solutions to achieve desorption and recovery of viruses from representative soils: a fine sand soil, an organic muck soil, a sandy loam soil, and a clay loam soil. One of the two methods, Goyal, also used a secondary concentration of resulting soil eluants via low-pH organic flocculation to achieve a smaller final assay volume. Evaluation of the two methods was simultaneously performed in replicate by nine different laboratories. Each of the produced samples was divided into portions, and these were respectively subjected to quantitative viral plaque assay by both the individual, termed independent, laboratory which had done the soil processing and a single common reference laboratory, using a single cell line and passage level. The Berg method seemed to produce slightly higher virus recovery values; however, the differences in virus assay titers for samples produced by the two methods were not statistically significant (P less than or equal to 0.05) for any one of the four soils. Despite this lack of a method effect, there was a statistically significant laboratory effect exhibited by assay titers from the independent versus reference laboratories for two of the soils, sandy loam and clay loam.

Multi-laboratory evaluations of the performance of Catellicoccus marimammalium PCR assays developed to target gull fecal sources

USGS Publications Warehouse

Sinigalliano, Christopher D.; Ervin, Jared S.; Van De Werfhorst, Laurie C.; Badgley, Brian D.; Ballestée, Elisenda; Bartkowiaka, Jakob; Boehm, Alexandria B.; Byappanahalli, Muruleedhara N.; Goodwin, Kelly D.; Gourmelon, Michèle; Griffith, John; Holden, Patricia A.; Jay, Jenny; Layton, Blythe; Lee, Cheonghoon; Lee, Jiyoung; Meijer, Wim G.; Noble, Rachel; Raith, Meredith; Ryu, Hodon; Sadowsky, Michael J.; Schriewer, Alexander; Wang, Dan; Wanless, David; Whitman, Richard; Wuertz, Stefan; Santo Domingo, Jorge W.

2013-01-01

Here we report results from a multi-laboratory (n = 11) evaluation of four different PCR methods targeting the 16S rRNA gene of Catellicoccus marimammalium originally developed to detect gull fecal contamination in coastal environments. The methods included a conventional end-point PCR method, a SYBR® Green qPCR method, and two TaqMan® qPCR methods. Different techniques for data normalization and analysis were tested. Data analysis methods had a pronounced impact on assay sensitivity and specificity calculations. Across-laboratory standardization of metrics including the lower limit of quantification (LLOQ), target detected but not quantifiable (DNQ), and target not detected (ND) significantly improved results compared to results submitted by individual laboratories prior to definition standardization. The unit of measure used for data normalization also had a pronounced effect on measured assay performance. Data normalization to DNA mass improved quantitative method performance as compared to enterococcus normalization. The MST methods tested here were originally designed for gulls but were found in this study to also detect feces from other birds, particularly feces composited from pigeons. Sequencing efforts showed that some pigeon feces from California contained sequences similar to C. marimammalium found in gull feces. These data suggest that the prevalence, geographic scope, and ecology of C. marimammalium in host birds other than gulls require further investigation. This study represents an important first step in the multi-laboratory assessment of these methods and highlights the need to broaden and standardize additional evaluations, including environmentally relevant target concentrations in ambient waters from diverse geographic regions.

First proficiency testing to evaluate the ability of European Union National Reference Laboratories to detect staphylococcal enterotoxins in milk products.

PubMed

Hennekinne, Jacques-Antoine; Gohier, Martine; Maire, Tiphaine; Lapeyre, Christiane; Lombard, Bertrand; Dragacci, Sylviane

2003-01-01

The European Commission has designed a network of European Union-National Reference Laboratories (EU-NRLs), coordinated by a Community Reference Laboratory (CRL), for control of hygiene of milk and milk products (Council Directive 92/46/ECC). As a common contaminant of milk and milk products such as cheese, staphylococcal enterotoxins are often involved in human outbreaks and should be monitored regularly. The main tasks of the EU-CRLs were to select and transfer to the EU-NRLs a reference method for detection of enterotoxins, and to set up proficiency testing to evaluate the competency of the European laboratory network. The first interlaboratory exercise was performed on samples of freeze-dried cheese inoculated with 2 levels of staphylococcal enterotoxins (0.1 and 0.25 ng/g) and on an uninoculated control. These levels were chosen considering the EU regulation for staphylococcal enterotoxins in milk and milk products and the limit of detection of the enzyme-linked immunosorbent assay test recommended in the reference method. The trial was conducted according to the recommendations of ISO Guide 43. Results produced by laboratories were compiled and compared through statistical analysis. Except for data from 2 laboratories for the uninoculated control and cheese inoculated at 0.1 ng/g, all laboratories produced satisfactory results, showing the ability of the EU-NRL network to monitor the enterotoxin contaminant.

Laboratory-based testing to evaluate abuse-deterrent formulations and satisfy the Food and Drug Administration's recommendation for Category 1 Testing.

PubMed

Altomare, Christopher; Kinzler, Eric R; Buchhalter, August R; Cone, Edward J; Costantino, Anthony

The US Food and Drug Administration (FDA) considers the development of abuse-deterrent formulations of solid oral dosage forms a public health priority and has outlined a series of premarket studies that should be performed prior to submitting an application to the Agency. Category 1 studies are performed to characterize whether the abuse-deterrent properties of a new formulation can be easily defeated. Study protocols are designed to evaluate common abuse patterns of prescription medications as well as more advanced methods that have been reported on drug abuse websites and forums. Because FDA believes Category 1 testing should fully characterize the abuse-deterrent characteristics of an investigational formulation, Category 1 testing is time consuming and requires specialized laboratory resources as well as advanced knowledge of prescription medication abuse. Recent Advisory Committee meetings at FDA have shown that Category 1 tests play a critical role in FDA's evaluation of an investigational formulation. In this article, we will provide a general overview of the methods of manipulation and routes of administration commonly utilized by prescription drug abusers, how those methods and routes are evaluated in a laboratory setting, and discuss data intake, analysis, and reporting to satisfy FDA's Category 1 testing requirements.

In vitro eye irritation testing using the open source reconstructed hemicornea - a ring trial.

PubMed

Mewes, Karsten R; Engelke, Maria; Zorn-Kruppa, Michaela; Bartok, Melinda; Tandon, Rashmi; Brandner, Johanna M; Petersohn, Dirk

2017-01-01

The aim of the present ring trial was to test whether two new methodological approaches for the in vitro classification of eye irritating chemicals can be reliably transferred from the developers' laboratories to other sites. Both test methods are based on the well-established open source reconstructed 3D hemicornea models. In the first approach, the initial depth of injury after chemical treatment in the hemicornea model is derived from the quantitative analysis of histological sections. In the second approach, tissue viability, as a measure for corneal damage after chemical treatment, is analyzed separately for epithelium and stroma of the hemicornea model. The three independent laboratories that participated in the ring trial produced their own hemicornea models according to the test producer's instructions, thus supporting the open source concept. A total of 9 chemicals with different physicochemical and eye-irritating properties were tested to assess the between-laboratory reproducibility (BLR), the predictive performance, as well as possible limitations of the test systems. The BLR was 62.5% for the first and 100% for the second method. Both methods enabled to discriminate Cat. 1 chemicals from all non-Cat. 1 substances, which qualifies them to be used in a top-down approach. However, the selectivity between No Cat. and Cat. 2 chemicals still needs optimization.

Lack of grading agreement among international hemostasis external quality assessment programs

PubMed Central

Olson, John D.; Jennings, Ian; Meijer, Piet; Bon, Chantal; Bonar, Roslyn; Favaloro, Emmanuel J.; Higgins, Russell A.; Keeney, Michael; Mammen, Joy; Marlar, Richard A.; Meley, Roland; Nair, Sukesh C.; Nichols, William L.; Raby, Anne; Reverter, Joan C.; Srivastava, Alok; Walker, Isobel

2018-01-01

Laboratory quality programs rely on internal quality control and external quality assessment (EQA). EQA programs provide unknown specimens for the laboratory to test. The laboratory's result is compared with other (peer) laboratories performing the same test. EQA programs assign target values using a variety of methods statistical tools and performance assessment of ‘pass’ or ‘fail’ is made. EQA provider members of the international organization, external quality assurance in thrombosis and hemostasis, took part in a study to compare outcome of performance analysis using the same data set of laboratory results. Eleven EQA organizations using eight different analytical approaches participated. Data for a normal and prolonged activated partial thromboplastin time (aPTT) and a normal and reduced factor VIII (FVIII) from 218 laboratories were sent to the EQA providers who analyzed the data set using their method of evaluation for aPTT and FVIII, determining the performance for each laboratory record in the data set. Providers also summarized their statistical approach to assignment of target values and laboratory performance. Each laboratory record in the data set was graded pass/fail by all EQA providers for each of the four analytes. There was a lack of agreement of pass/fail grading among EQA programs. Discordance in the grading was 17.9 and 11% of normal and prolonged aPTT results, respectively, and 20.2 and 17.4% of normal and reduced FVIII results, respectively. All EQA programs in this study employed statistical methods compliant with the International Standardization Organization (ISO), ISO 13528, yet the evaluation of laboratory results for all four analytes showed remarkable grading discordance. PMID:29232255

Failure analysis of electronic parts: Laboratory methods. [for destructive and nondestructive testing

NASA Technical Reports Server (NTRS)

Anstead, R. J. (Editor); Goldberg, E. (Editor)

1975-01-01

Failure analysis test methods are presented for use in analyzing candidate electronic parts and in improving future design reliability. Each test is classified as nondestructive, semidestructive, or destructive. The effects upon applicable part types (i.e. integrated circuit, transitor) are discussed. Methodology is given for performing the following: immersion tests, radio graphic tests, dewpoint tests, gas ambient analysis, cross sectioning, and ultraviolet examination.

College of American Pathologists/American College of Medical Genetics proficiency testing for constitutional cytogenomic microarray analysis.

PubMed

Brothman, Arthur R; Dolan, Michelle M; Goodman, Barbara K; Park, Jonathan P; Persons, Diane L; Saxe, Debra F; Tepperberg, James H; Tsuchiya, Karen D; Van Dyke, Daniel L; Wilson, Kathleen S; Wolff, Daynna J; Theil, Karl S

2011-09-01

To evaluate the feasibility of administering a newly established proficiency test offered through the College of American Pathologists and the American College of Medical Genetics for genomic copy number assessment by microarray analysis, and to determine the reproducibility and concordance among laboratory results from this test. Surveys were designed through the Cytogenetic Resource Committee of the two colleges to assess the ability of testing laboratories to process DNA samples provided and interpret results. Supplemental questions were asked with each Survey to determine laboratory practice trends. Twelve DNA specimens, representing 2 pilot and 10 Survey challenges, were distributed to as many as 74 different laboratories, yielding 493 individual responses. The mean consensus for matching result interpretations was 95.7%. Responses to supplemental questions indicate that the number of laboratories offering this testing is increasing, methods for analysis and evaluation are becoming standardized, and array platforms used are increasing in probe density. The College of American Pathologists/American College of Medical Genetics proficiency testing program for copy number assessment by cytogenomic microarray is a successful and efficient mechanism for assessing interlaboratory reproducibility. This will provide laboratories the opportunity to evaluate their performance and assure overall accuracy of patient results. The high level of concordance in laboratory responses across all testing platforms by multiple facilities highlights the robustness of this technology.

Comparison of the Modified-Hodge test, Carba NP test, and carbapenem inactivation method as screening methods for carbapenemase-producing Enterobacteriaceae.

PubMed

Yamada, Kageto; Kashiwa, Machiko; Arai, Katsumi; Nagano, Noriyuki; Saito, Ryoichi

2016-09-01

We compared three screening methods for carbapenemase-producing Enterobacteriaceae. While the Modified-Hodge test and Carba NP test produced false-negative results for OXA-48-like and mucoid NDM producers, the carbapenem inactivation method (CIM) showed positive results for these isolates. Although the CIM required cultivation time, it is well suited for general clinical laboratories. Copyright © 2016 Elsevier B.V. All rights reserved.

Proficiency testing of Hb A1c: a 4-year experience in Taiwan and the Asian Pacific region.

PubMed

Shiesh, Shu-Chu; Wiedmeyer, Hsiao-Mei; Kao, Jau-Tsuen; Vasikaran, Samuel D; Lopez, Joseph B

2009-10-01

The correlation between hemoglobin A(1c) (Hb A(1c)) and risk for complications in diabetic patients heightens the need to measure Hb A(1c) with accuracy. We evaluated the current performance for measuring Hb A(1c) in the Asian and Pacific region by examining data submitted by laboratories participating in the Taiwan proficiency-testing program. Five fresh-pooled blood samples were sent to participating laboratories twice each year. The results were evaluated against target values assigned by the National Glycohemoglobin Standardization Program network laboratories; a passing criterion of +/-7% of the target value was used. Measurement uncertainty at Hb A(1c) concentrations of 7.0% and 8.0% were determined. A total of 276 laboratories from 11 countries took part in the Hb A(1c) survey. At the Hb A(1c) concentrations tested method-specific interlaboratory imprecision (CVs) were 1.1%-13.9% in 2005, 1.3%-10.1% in 2006, 1.2%-8.2% in 2007, and 1.1%-6.1% in 2008. Differences between target values and median values from the commonly used methods ranged from -0.24% to 0.22% Hb A(1c) in 2008. In 2005 83% of laboratories passed the survey, and in 2008 93% passed. At 7.0% Hb A(1c), measurement uncertainty was on average 0.49% Hb A(1c). The use of accuracy-based proficiency testing with stringent quality criteria has improved the performance of Hb A(1c) testing in the Asian and Pacific laboratories during the 4 years of assessment.

Development of an evidence-based approach to external quality assurance for breast cancer hormone receptor immunohistochemistry: comparison of reference values.

PubMed

Makretsov, Nikita; Gilks, C Blake; Alaghehbandan, Reza; Garratt, John; Quenneville, Louise; Mercer, Joel; Palavdzic, Dragana; Torlakovic, Emina E

2011-07-01

External quality assurance and proficiency testing programs for breast cancer predictive biomarkers are based largely on traditional ad hoc design; at present there is no universal consensus on definition of a standard reference value for samples used in external quality assurance programs. To explore reference values for estrogen receptor and progesterone receptor immunohistochemistry in order to develop an evidence-based analytic platform for external quality assurance. There were 31 participating laboratories, 4 of which were previously designated as "expert" laboratories. Each participant tested a tissue microarray slide with 44 breast carcinomas for estrogen receptor and progesterone receptor and submitted it to the Canadian Immunohistochemistry Quality Control Program for analysis. Nuclear staining in 1% or more of the tumor cells was a positive score. Five methods for determining reference values were compared. All reference values showed 100% agreement for estrogen receptor and progesterone receptor scores, when indeterminate results were excluded. Individual laboratory performance (agreement rates, test sensitivity, test specificity, positive predictive value, negative predictive value, and κ value) was very similar for all reference values. Identification of suboptimal performance by all methods was identical for 30 of 31 laboratories. Estrogen receptor assessment of 1 laboratory was discordant: agreement was less than 90% for 3 of 5 reference values and greater than 90% with the use of 2 other reference values. Various reference values provide equivalent laboratory rating. In addition to descriptive feedback, our approach allows calculation of technical test sensitivity and specificity, positive and negative predictive values, agreement rates, and κ values to guide corrective actions.

Laboratory diagnosis of creatine deficiency syndromes: a technical standard and guideline of the American College of Medical Genetics and Genomics.

PubMed

Sharer, J Daniel; Bodamer, Olaf; Longo, Nicola; Tortorelli, Silvia; Wamelink, Mirjam M C; Young, Sarah

2017-02-01

Disclaimer: These ACMG Standards and Guidelines are intended as an educational resource for clinical laboratory geneticists to help them provide quality clinical laboratory genetic services. Adherence to these standards and guidelines is voluntary and does not necessarily assure a successful medical outcome. These Standards and Guidelines should not be considered inclusive of all proper procedures and tests or exclusive of others that are reasonably directed to obtaining the same results. In determining the propriety of any specific procedure or test, clinical laboratory geneticists should apply their professional judgment to the specific circumstances presented by the patient or specimen. Clinical laboratory geneticists are encouraged to document in the patient's record the rationale for the use of a particular procedure or test, whether or not it is in conformance with these Standards and Guidelines. They also are advised to take notice of the date any particular guideline was adopted, and to consider other relevant medical and scientific information that becomes available after that date. It also would be prudent to consider whether intellectual property interests may restrict the performance of certain tests and other procedures.Cerebral creatine deficiency syndromes are neurometabolic conditions characterized by intellectual disability, seizures, speech delay, and behavioral abnormalities. Several laboratory methods are available for preliminary and confirmatory diagnosis of these conditions, including measurement of creatine and related metabolites in biofluids using liquid chromatography-tandem mass spectrometry or gas chromatography-mass spectrometry, enzyme activity assays in cultured cells, and DNA sequence analysis. These guidelines are intended to standardize these procedures to help optimize the diagnosis of creatine deficiency syndromes. While biochemical methods are emphasized, considerations for confirmatory molecular testing are also discussed, along with variables that influence test results and interpretation.Genet Med 19 2, 256-263.

Recent advances in materials toxicology

NASA Technical Reports Server (NTRS)

Russo, D. M.

1979-01-01

An overview of the fire toxicology program, its principal objectives and approach, is outlined. The laboratory methods of assessing pyrolysis product toxicity for two experiments are presented. The two experiments are: a comparison of test end points; and an evaluation of operant techniques. A third experiment is outlined for a comparison of full-scale and laboratory toxicity tests, with the purpose of determining animal survivability in full-scale tests. Future research plans are also outlined.

Transferability and within- and between-laboratory reproducibilities of EpiSensA for predicting skin sensitization potential in vitro: A ring study in three laboratories.

PubMed

Mizumachi, Hideyuki; Sakuma, Megumi; Ikezumi, Mayu; Saito, Kazutoshi; Takeyoshi, Midori; Imai, Noriyasu; Okutomi, Hiroko; Umetsu, Asami; Motohashi, Hiroko; Watanabe, Mika; Miyazawa, Masaaki

2018-05-03

The epidermal sensitization assay (EpiSensA) is an in vitro skin sensitization test method based on gene expression of four markers related to the induction of skin sensitization; the assay uses commercially available reconstructed human epidermis. EpiSensA has exhibited an accuracy of 90% for 72 chemicals, including lipophilic chemicals and pre-/pro-haptens, when compared with the results of the murine local lymph node assay. In this work, a ring study was performed by one lead and two naive laboratories to evaluate the transferability, as well as within- and between-laboratory reproducibilities, of EpiSensA. Three non-coded chemicals (two lipophilic sensitizers and one non-sensitizer) were tested for the assessment of transferability and 10 coded chemicals (seven sensitizers and three non-sensitizers, including four lipophilic chemicals) were tested for the assessment of reproducibility. In the transferability phase, the non-coded chemicals (two sensitizers and one non-sensitizer) were correctly classified at the two naive laboratories, indicating that the EpiSensA protocol was transferred successfully. For the within-laboratory reproducibility, the data generated with three coded chemicals tested in three independent experiments in each laboratory gave consistent predictions within laboratories. For the between-laboratory reproducibility, 9 of the 10 coded chemicals tested once in each laboratory provided consistent predictions among the three laboratories. These results suggested that EpiSensA has good transferability, as well as within- and between-laboratory reproducibility. Copyright © 2018 John Wiley & Sons, Ltd.

Competency assessment of microbiology medical laboratory technologists in Ontario, Canada.

PubMed

Desjardins, Marc; Fleming, Christine Ann

2014-08-01

Accreditation in Ontario, Canada, requires that licensed clinical laboratories participate in external quality assessment (also known as proficiency testing) and perform competency evaluation of their staff. To assess the extent of ongoing competency assessment practices, the Quality Management Program--Laboratory Services (QMP-LS) Microbiology Committee surveyed all 112 licensed Ontario microbiology laboratories. The questionnaire consisted of a total of 21 questions that included yes/no, multiple-choice, and short-answer formats. Participants were asked to provide information about existing programs, the frequency of testing, what areas are evaluated, and how results are communicated to the staff. Of the 111 responding laboratories, 6 indicated they did not have a formal evaluation program since they perform only limited bacteriology testing. Of the remaining 105 respondents, 87% perform evaluations at least annually or every 2 years, and 61% include any test or task performed, whereas 16% and 10% focus only on problem areas and high-volume complex tasks, respectively. The most common methods of evaluation were review of external quality assessment (EQA) challenges, direct observation, and worksheet review. With the exception of one participant, all communicate results to staff, and most take remedial action to correct the deficiencies. Although most accredited laboratories have a program to assess the ongoing competency of their staff, the methods used are not standardized or consistently applied, indicating that there is room for improvement. The survey successfully highlighted potential areas for improvement and allowed the QMP-LS Microbiology Committee to provide guidance to Ontario laboratories for establishing or improving existing microbiology-specific competency assessment programs. Copyright © 2014, American Society for Microbiology. All Rights Reserved.

Competency Assessment of Microbiology Medical Laboratory Technologists in Ontario, Canada

PubMed Central

Fleming, Christine Ann

2014-01-01

Accreditation in Ontario, Canada, requires that licensed clinical laboratories participate in external quality assessment (also known as proficiency testing) and perform competency evaluation of their staff. To assess the extent of ongoing competency assessment practices, the Quality Management Program—Laboratory Services (QMP-LS) Microbiology Committee surveyed all 112 licensed Ontario microbiology laboratories. The questionnaire consisted of a total of 21 questions that included yes/no, multiple-choice, and short-answer formats. Participants were asked to provide information about existing programs, the frequency of testing, what areas are evaluated, and how results are communicated to the staff. Of the 111 responding laboratories, 6 indicated they did not have a formal evaluation program since they perform only limited bacteriology testing. Of the remaining 105 respondents, 87% perform evaluations at least annually or every 2 years, and 61% include any test or task performed, whereas 16% and 10% focus only on problem areas and high-volume complex tasks, respectively. The most common methods of evaluation were review of external quality assessment (EQA) challenges, direct observation, and worksheet review. With the exception of one participant, all communicate results to staff, and most take remedial action to correct the deficiencies. Although most accredited laboratories have a program to assess the ongoing competency of their staff, the methods used are not standardized or consistently applied, indicating that there is room for improvement. The survey successfully highlighted potential areas for improvement and allowed the QMP-LS Microbiology Committee to provide guidance to Ontario laboratories for establishing or improving existing microbiology-specific competency assessment programs. PMID:24899030

Postdoctoral Professional Fellowships in Laboratory Medicine.

PubMed

Straseski, Joely A

2013-04-01

Doctoral level scientists often pursue a traditional academic route, focusing their efforts on research and education. However, additional options exist for those that are interested in using their laboratory and research skills in a clinical setting. Clinical laboratory directors serve as the interface between the clinical laboratory and the users of laboratory test results. This article describes these career paths options for PhD scientists. Clinical laboratory directors are primarily trained via one of two routes: physicians that have been trained in clinical pathology or non-physician doctoral scientists that have completed professional fellowship training. This article will focus on the latter of these 2 routes. In the United States, completing a postdoctoral fellowship in laboratory-specific professional fields qualifies non-physician doctoral scientists as laboratory directors and consultants. Their expert consultation provides invaluable insight into testing procedures such as possible sources of interference or inaccurate test results, preferred testing for specific clinical situations, and confirmatory methods. They must also be knowledgeable about current instrumentation, assay limitations, and the newest available technologies. One of the older and more developed professional fellowships in the United States, clinical chemistry, encompasses many laboratory disciplines and will be highlighted in detail. Training information specific to clinical immunology, clinical microbiology, and clinical genetics is also discussed.

Validation of a laboratory and hospital information system in a medical laboratory accredited according to ISO 15189

PubMed Central

Biljak, Vanja Radisic; Ozvald, Ivan; Radeljak, Andrea; Majdenic, Kresimir; Lasic, Branka; Siftar, Zoran; Lovrencic, Marijana Vucic; Flegar-Mestric, Zlata

2012-01-01

Introduction The aim of the study was to present a protocol for laboratory information system (LIS) and hospital information system (HIS) validation at the Institute of Clinical Chemistry and Laboratory Medicine of the Merkur University Hospital, Zagreb, Croatia. Materials and methods: Validity of data traceability was checked by entering all test requests for virtual patient into HIS/LIS and printing corresponding barcoded labels that provided laboratory analyzers with the information on requested tests. The original printouts of the test results from laboratory analyzer(s) were compared with the data obtained from LIS and entered into the provided template. Transfer of data from LIS to HIS was examined by requesting all tests in HIS and creating real data in a finding generated in LIS. Data obtained from LIS and HIS were entered into a corresponding template. The main outcome measure was the accuracy of transfer obtained from laboratory analyzers and results transferred from LIS and HIS expressed as percentage (%). Results: The accuracy of data transfer from laboratory analyzers to LIS was 99.5% and of that from LIS to HIS 100%. Conclusion: We presented our established validation protocol for laboratory information system and demonstrated that a system meets its intended purpose. PMID:22384522

Increasing Efficiency of Fecal Coliform Testing Through EPA-Approved Alternate Method Colilert*-18

NASA Technical Reports Server (NTRS)

Cornwell, Brian

2017-01-01

The 21 SM 9221 E multiple-tube fermentation method for fecal coliform analysis requires a large time and reagent investment for the performing laboratory. In late 2010, the EPA approved an alternative procedure for the determination of fecal coliforms designated as Colilert*-18. However, as of late 2016, only two VELAP-certified laboratories in the Commonwealth of Virginia have been certified in this method.

Survey of Clinical Laboratory Practices for 2015 Middle East Respiratory Syndrome Coronavirus Outbreak in the Republic of Korea

PubMed Central

Lee, Mi-Kyung; Kim, Sinyoung; Kim, Mi-Na; Kweon, Oh Joo; Lim, Yong Kwan; Ki, Chang-Seok; Kim, Jae-Seok; Seong, Moon-Woo; Sung, Heungsup; Yong, Dongeun; Lee, Hyukmin; Choi, Jong-Rak

2016-01-01

Background It is crucial to understand the current status of clinical laboratory practices for the largest outbreak of Middle East respiratory syndrome coronavirus (MERS-CoV) infections in the Republic of Korea to be well prepared for future emerging infectious diseases. Methods We conducted a survey of 49 clinical laboratories in medical institutions and referral medical laboratories. A short questionnaire to survey clinical laboratory practices relating to MERS-CoV diagnostic testing was sent by email to the directors and clinical pathologists in charge of the clinical laboratories performing MERS-CoV testing. The survey focused on testing volume, reporting of results, resources, and laboratory safety. Results A total of 40 clinical laboratories responded to the survey. A total of 27,009 MERS-CoV real-time reverse transcription PCR (rRT-PCR) tests were performed. Most of the specimens were sputum (73.5%). The median turnaround time (TAT) was 5.29 hr (first and third quartile, 4.11 and 7.48 hr) in 26 medical institutions. The median TAT of more than a half of the laboratories (57.7%) was less than 6 hr. Many laboratories were able to perform tests throughout the whole week. Laboratory biosafety preparedness included class II biosafety cabinets (100%); separated pre-PCR, PCR, and post-PCR rooms (88.6%); negative pressure pretreatment rooms (48.6%); and negative pressure sputum collection rooms (20.0%). Conclusions Clinical laboratories were able to quickly expand their diagnostic capacity in response to the 2015 MERS-CoV outbreak. Our results show that clinical laboratories play an important role in the maintenance and enhancement of laboratory response in preparation for future emerging infections. PMID:26709263

Analysis of laboratory compaction methods of roller compacted concrete

NASA Astrophysics Data System (ADS)

Trtík, Tomáš; Chylík, Roman; Bílý, Petr; Fládr, Josef

2017-09-01

Roller-Compacted Concrete (RCC) is an ordinary concrete poured and compacted with machines typically used for laying of asphalt road layers. One of the problems connected with this technology is preparation of representative samples in the laboratory. The aim of this work was to analyse two methods of preparation of RCC laboratory samples with bulk density as the comparative parameter. The first method used dynamic compaction by pneumatic hammer. The second method of compaction had a static character. The specimens were loaded by precisely defined force in laboratory loading machine to create the same conditions as during static rolling (in the Czech Republic, only static rolling is commonly used). Bulk densities obtained by the two compaction methods were compared with core drills extracted from real RCC structure. The results have shown that the samples produced by pneumatic hammer tend to overestimate the bulk density of the material. For both compaction methods, immediate bearing index test was performed to verify the quality of compaction. A fundamental difference between static and dynamic compaction was identified. In static compaction, initial resistance to penetration of the mandrel was higher, after exceeding certain limit the resistance was constant. This means that the samples were well compacted just on the surface. Specimens made by pneumatic hammer actively resisted throughout the test, the whole volume was uniformly compacted.

Evaluation of a rabies ELISA as an alternative method to seroneutralisation tests in the context of international trade of domestic carnivores.

PubMed

Wasniewski, M; Labbe, A; Tribout, L; Rieder, J; Labadie, A; Schereffer, J L; Cliquet, F

2014-01-01

For several years, international movements with pets have greatly increased. Most countries have relaxed their quarantine measures and adopted a scheme combining vaccination of pets against rabies followed by a serological test to check the efficacy of vaccination. This new scheme has been strongly supported by the OIE, WHO and the European Commission to facilitate the free movement of people and pets around the world. Currently, only two reference methods are recognised and prescribed (the FAVN test and the RFFIT) to measure rabies antibody levels in serum samples for international trade. They are reliable and valuable methods of assessing the efficacy of rabies vaccination but they are time-consuming and require well-trained people and specialised laboratory facilities. A few years ago, an ELISA (Platelia™ Rabies II kit ad usum Veterinarium) was developed for domestic carnivores and wildlife. To our knowledge, this ELISA is the only one certified and prescribed by the OIE. Following its marketing, one task of the EURL for rabies serology was to evaluate the performance of laboratories using this new kit. The results revealed that 26% of the participants, which were already approved laboratories for rabies serology, failed the inter-laboratory trial. Such unsatisfactory results have never been observed during any of the previous proficiency tests organised annually since 2000 by the EURL for rabies serology using reference methods. More investigations were undertaken through internal and collaborative studies to assess the performance of this newly marketed ELISA kit. The results of the internal study revealed that even with a specificity of 100%, the sensitivity evaluated on 593 samples of domestic carnivores came to 78.2%. An issue regarding the underestimation of serum titres was also revealed during the study. The results of a collaborative study involving 23 international laboratories reinforced the preliminary conclusions regarding lack of sensitivity. Indeed, only 5 laboratories out of the 23 obtained satisfactory results. We therefore suggest adopting a threshold of 0.3 EU/mL instead of 0.5 EU/mL to increase the sensitivity of the test. Copyright © 2013 Elsevier B.V. All rights reserved.

Laboratory practice at the periphery in developing countries.

PubMed

Lewis, S M

2002-08-01

An effective national health service structure requires a comprehensive programme for primary health care in peripheral and rural areas. This is especially important in under-resourced countries where facilities are sparse, the population is widely dispersed and transport is limited. Haematology has a key role in diagnosis and patient management by selecting tests for their clinical relevance and utility for the specific circumstances, and ensuring their technical reliability when used in health clinics and point-of-care testing. WHO has proposed a basic menu of tests in three categories: (a) tests such as haemoglobin screen which can be performed by nurses, midwives, health-aides or community doctors, (b) tests such as haemoglobinometry, microhaematocrit and microscopic examination of stained preparations which can be performed by a technician or laboratory assistant in a health centre, (c) tests requiring greater technical expertise of a laboratory technician or trained doctor. The peripheral health clinics and district laboratories must be familiar with the guidelines on standardized methods for collecting and storing specimens and transporting them to a regional laboratory or a reference centre. A training syllabus should be provided at the health centres and district laboratories, and this should include on-site instruction from supervisors and access to training manuals and distance-learning material. A co-ordinated programme of quality assurance and standardization of test methods should be established by a reference centre or national health authority with a network which encompasses all laboratories and health clinics undertaking any tests. Each regional laboratory should foster lower level laboratories or clinics within its neighbourhood. Of particular concern is the reliable diagnosis and management of anaemia. WHO reports indicate that 40% of the world population suffer from anaemia, especially affecting pregnant women, and a high proportion of infants and children in developing countries. The Haemoglobin Colour Scale (HCS) was recently developed for WHO as a simple, cheap and portable device which reads haemoglobin within 1 g/dl of the true value. It has been validated in a number of studies and is now manufactured commercially in accordance with WHO specifications under control of a WHO Collaborating Centre. It has an important potential role in the resource-limited environment where anaemia screening presently usually depends on unreliable clinical examination.

The Changing Role of the Clinical Microbiology Laboratory in Defining Resistance in Gram-negatives.

PubMed

Endimiani, Andrea; Jacobs, Michael R

2016-06-01

The evolution of resistance in Gram-negatives has challenged the clinical microbiology laboratory to implement new methods for their detection. Multidrug-resistant strains present major challenges to conventional and new detection methods. More rapid pathogen identification and antimicrobial susceptibility testing have been developed for use directly on specimens, including fluorescence in situ hybridization tests, automated polymerase chain reaction systems, microarrays, mass spectroscopy, next-generation sequencing, and microfluidics. Review of these methods shows the advances that have been made in rapid detection of resistance in cultures, but limited progress in direct detection from specimens. Copyright © 2016 Elsevier Inc. All rights reserved.

Standardization of Terminology in Laboratory Medicine II

PubMed Central

Lee, Kap No; Yoon, Jong-Hyun; Min, Won Ki; Lim, Hwan Sub; Song, Junghan; Chae, Seok Lae; Jang, Seongsoo; Ki, Chang-Seok; Bae, Sook Young; Kim, Jang Su; Kwon, Jung-Ah; Lee, Chang Kyu

2008-01-01

Standardization of medical terminology is essential in data transmission between health care institutes and in maximizing the benefits of information technology. The purpose of this study was to standardize medical terms for laboratory observations. During the second year of the study, a standard database of concept names for laboratory terms that covered those used in tertiary health care institutes and reference laboratories was developed. The laboratory terms in the Logical Observation Identifier Names and Codes (LOINC) database were adopted and matched with the electronic data interchange (EDI) codes in Korea. A public hearing and a workshop for clinical pathologists were held to collect the opinions of experts. The Korean standard laboratory terminology database containing six axial concept names, components, property, time aspect, system (specimen), scale type, and method type, was established for 29,340 test observations. Short names and mapping tables for EDI codes and UMLS were added. Synonym tables were prepared to help match concept names to common terms used in the fields. We herein described the Korean standard laboratory terminology database for test names, result description terms, and result units encompassing most of the laboratory tests in Korea. PMID:18756062

FIELD CHECK MANUAL FOR LANGUAGE LABORATORIES, A SERIES OF TESTS WHICH A NON-TECHNICAL PERSON CAN CONDUCT TO VERIFY SPECIFICATIONS.

ERIC Educational Resources Information Center

GRITTNER, FRANK; PAVLAT, RUSSELL

IN ORDER TO ASSIST NON-TECHNICAL PEOPLE IN SCHOOLS TO CONDUCT A FIELD CHECK OF LANGUAGE LABORATORY EQUIPMENT BEFORE THEY MAKE FINAL PAYMENTS, THIS MANUAL OFFERS CRITERIA, TESTS, AND METHODS OF SCORING THE QUALITY OF THE EQUIPMENT. CHECKLISTS ARE PROVIDED FOR EVALUATING CONSOLE FUNCTIONS, TAPE RECORDERS, AMPLIFIERS, SOUND QUALITY (INCLUDING…

Developing Methodologies to Find Abbreviated Laboratory Test Names in Narrative Clinical Documents by Generating High Quality Q-Grams.

PubMed

Kim, Kyungmo; Choi, Jinwook

2017-01-01

Laboratory test names are used as basic information to diagnose diseases. However, this kind of medical information is usually written in a natural language. To find this information, lexicon based methods have been good solutions but they cannot find terms that do not have abbreviated expressions, such as "neuts" that means "neutrophils". To address this issue, similar word matching can be used; however, it can be disadvantageous because of significant false positives. Moreover, processing time is longer as the size of terms is bigger. Therefore, we suggest a novel q-gram based algorithm, named modified triangular area filtering, to find abbreviated laboratory test terms in clinical documents, minimizing the possibility to impair the lexicons' precision. In addition, we found the terms using the methodology with reasonable processing time. The results show that this method can achieve 92.54 precision, 87.72 recall, 90.06 f1-score in test sets when edit distance threshold(τ) = 3.

A study of the impact of collaborative learning on student learning of major concepts in a microbiology laboratory exercise

NASA Astrophysics Data System (ADS)

Baumgarten, Kristyne A.

This study investigated the possible relationship between collaborative learning strategies and the learning of core concepts. This study examined the differences between two groups of nursing students enrolled in an introductory microbiology laboratory course. The control group consisted of students enrolled in sections taught in the traditional method. The experimental group consisted of those students enrolled in the sections using collaborative learning strategies. The groups were assessed on their degrees of learning core concepts using a pre-test/post-test method. Scores from the groups' laboratory reports were also analyzed. There was no difference in the two group's pre-test scores. The post-test scores of the experimental group averaged 11 points higher than the scores of the control group. The lab report scores of the experimental group averaged 15 points higher than those scores of the control group. The data generated from this study demonstrated that collaborative learning strategies can be used to increase students learning of core concepts in microbiology labs.

Guidance for laboratories performing molecular pathology for cancer patients.

PubMed

Cree, Ian A; Deans, Zandra; Ligtenberg, Marjolijn J L; Normanno, Nicola; Edsjö, Anders; Rouleau, Etienne; Solé, Francesc; Thunnissen, Erik; Timens, Wim; Schuuring, Ed; Dequeker, Elisabeth; Murray, Samuel; Dietel, Manfred; Groenen, Patricia; Van Krieken, J Han

2014-11-01

Molecular testing is becoming an important part of the diagnosis of any patient with cancer. The challenge to laboratories is to meet this need, using reliable methods and processes to ensure that patients receive a timely and accurate report on which their treatment will be based. The aim of this paper is to provide minimum requirements for the management of molecular pathology laboratories. This general guidance should be augmented by the specific guidance available for different tumour types and tests. Preanalytical considerations are important, and careful consideration of the way in which specimens are obtained and reach the laboratory is necessary. Sample receipt and handling follow standard operating procedures, but some alterations may be necessary if molecular testing is to be performed, for instance to control tissue fixation. DNA and RNA extraction can be standardised and should be checked for quality and quantity of output on a regular basis. The choice of analytical method(s) depends on clinical requirements, desired turnaround time, and expertise available. Internal quality control, regular internal audit of the whole testing process, laboratory accreditation, and continual participation in external quality assessment schemes are prerequisites for delivery of a reliable service. A molecular pathology report should accurately convey the information the clinician needs to treat the patient with sufficient information to allow for correct interpretation of the result. Molecular pathology is developing rapidly, and further detailed evidence-based recommendations are required for many of the topics covered here. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Laboratory tests for hot-mix asphalt characterization in Virginia.

DOT National Transportation Integrated Search

2005-01-01

This project reviewed existing laboratory methods for accurately describing the constitutive behavior of the mixes used in the Commonwealth of Virginia. Indirect tensile (IDT) strength, resilient modulus, static creep in the IDT and uniaxial modes, f...

A comparison of the BAX system method to the U.S. Food and Drug Administration's Bacteriological Analytical Manual and International Organization for Standardization reference methods for the detection of Salmonella in a variety of soy ingredients.

PubMed

Belete, Tamrat; Crowley, Erin; Bird, Patrick; Gensic, Joseph; Wallace, F Morgan

2014-10-01

The performances of two DuPont BAX System PCR assays for detecting Salmonella on a variety of low-moisture soy ingredients were evaluated against the U. S. Food and Drug Administration's Bacteriological Analytical Manual (FDA BAM) method or the International Organization for Standardization (ISO) 6579 reference method. These evaluations were conducted as a single laboratory validation at an ISO 17025 accredited third-party laboratory. Validations were conducted on five soy ingredients: isolated soy protein (ISP), soy fiber, fluid soy lecithin, deoiled soy lecithin, and soy nuggets, using a paired-study design. The ISP was analyzed as both 25- and 375-g composite test portions, whereas all other sample matrices were analyzed as 375-g composite test portions. To evaluate 25-g test portions of ISP, the test material was inoculated using Salmonella enterica subsp. enterica serovar Mbandaka (Q Laboratories isolate 11031.1). Salmonella enterica subsp. enterica serovar Tennessee (Q Laboratories isolate 11031.3) was used for all other trials. For each trial of the method comparison, 25 samples were analyzed for each matrix: 5 uninoculated controls and 20 samples inoculated at low levels (0.2 to 2 CFU per test portion) that were targeted to achieve fractionally positive results (25 to 75%). Using McNemar's chi-square analysis, no significant difference at P ≥ 0.05 (χ(2) ≤ 3.84) was observed between the number of positives obtained by the BAX System and the reference methods for all five test matrices evaluated. These studies indicate that the BAX System PCR assays, in combination with the single buffered peptone water primary enrichment and subsequent brain heart infusion regrowth step, demonstrate equivalent sensitivity and robustness compared with the FDA BAM and ISO reference methods for both 25- and 375-g composite samples. Moreover, there was no observed reduction of sensitivity in the larger 375-g composite samples for all five matrices.

Operational plans for life science payloads - From experiment selection through postflight reporting

NASA Technical Reports Server (NTRS)

Mccollum, G. W.; Nelson, W. G.; Wells, G. W.

1976-01-01

Key features of operational plans developed in a study of the Space Shuttle era life science payloads program are presented. The data describes the overall acquisition, staging, and integration of payload elements, as well as program implementation methods and mission support requirements. Five configurations were selected as representative payloads: (a) carry-on laboratories - medical emphasis experiments, (b) mini-laboratories - medical/biology experiments, (c) seven-day dedicated laboratories - medical/biology experiments, (d) 30-day dedicated laboratories - Regenerative Life Support Evaluation (RLSE) with selected life science experiments, and (e) Biomedical Experiments Scientific Satellite (BESS) - extended duration primate (Type I) and small vertebrate (Type II) missions. The recommended operational methods described in the paper are compared to the fundamental data which has been developed in the life science Spacelab Mission Simulation (SMS) test series. Areas assessed include crew training, experiment development and integration, testing, data-dissemination, organization interfaces, and principal investigator working relationships.

Comparison of a New and Rapid Method: Brucella Coombs Gel Test With Other Diagnostic Tests.

PubMed

Kalem, Fatma; Ergün, Ayşe Gül; Durmaz, Süleyman; Doğan, Metin; Ertuğrul, Ömür; Gündem, Seval

2016-09-01

The aim of this study was to detect reliability of Brucella Coombs gel test (BCGT) by comparing with with ELISA (IgG + IgM), Standard agglutination test, and Brucella immunocapture agglutination methods in serological diagnosis of brucellosis. Brucella Coombs gel test (BCGT), Brucella ELISA (IgG + IgM), Standard agglutination test, and Brucella immunocapture agglutination tests of 78 patients with presumptive diagnosis of brucellosis which were sent to Microbiology Laboratory of Konya Numune Hospital from various regions of Konya were studied. Of 78 patients with ELISA IgG and IgM, STA, BICA and BCGT; 26, 21, 10, 12 and 12 were positive. When compared with BICA, the sensitivity and specifity of BCGT were 100% and 100%, respectively. According to results BCGT can be used as a diagnostic test in routine laboratories after more comprehensive studies in control groups and patients. © 2016 Wiley Periodicals, Inc.

Physicochemical inactivation of Lassa, Ebola, and Marburg viruses and effect on clinical laboratory analyses

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

Mitchell, S.W.; McCormick, J.B.

1984-09-01

Clinical specimens from patients infected with Lassa, Ebola, or Marburg virus may present a serious biohazard to laboratory workers. The authors have examined the effects of heat, alteration of pH, and gamma radiation on these viruses in human blood and on the electrolytes, enzymes, and coagulation factors measured in laboratory tests that are important in the care of an infected patient. Heating serum at 60 degrees C for 1 h reduced high titers of these viruses to noninfectious levels without altering the serum levels of glucose, blood urea nitrogen, and electrolytes. Dilution of blood in 3% acetic acid, diluent formore » a leukocyte count, inactivated all of these viruses. All of the methods tested for viral inactivation markedly altered certain serum proteins, making these methods unsuitable for samples that are to be tested for certain enzyme levels and coagulation factors.« less

An improved stress corrosion test medium for aluminum alloys

NASA Technical Reports Server (NTRS)

Humphries, T. S.; Coston, J. E.

1981-01-01

A laboratory test method that is only mildly corrosive to aluminum and discriminating for use in classifying the stress corrosion cracking resistance of aluminum alloys is presented along with the method used in evaluating the media selected for testing. The proposed medium is easier to prepare and less expensive than substitute ocean water.

Evaluation of the performance of a micromethod for measuring urinary iodine by using six sigma quality metrics.

PubMed

Hussain, Husniza; Khalid, Norhayati Mustafa; Selamat, Rusidah; Wan Nazaimoon, Wan Mohamud

2013-09-01

The urinary iodine micromethod (UIMM) is a modification of the conventional method and its performance needs evaluation. UIMM performance was evaluated using the method validation and 2008 Iodine Deficiency Disorders survey data obtained from four urinary iodine (UI) laboratories. Method acceptability tests and Sigma quality metrics were determined using total allowable errors (TEas) set by two external quality assurance (EQA) providers. UIMM obeyed various method acceptability test criteria with some discrepancies at low concentrations. Method validation data calculated against the UI Quality Program (TUIQP) TEas showed that the Sigma metrics were at 2.75, 1.80, and 3.80 for 51±15.50 µg/L, 108±32.40 µg/L, and 149±38.60 µg/L UI, respectively. External quality control (EQC) data showed that the performance of the laboratories was within Sigma metrics of 0.85-1.12, 1.57-4.36, and 1.46-4.98 at 46.91±7.05 µg/L, 135.14±13.53 µg/L, and 238.58±17.90 µg/L, respectively. No laboratory showed a calculated total error (TEcalc)

Exponential error reduction in pretransfusion testing with automation.

PubMed

South, Susan F; Casina, Tony S; Li, Lily

2012-08-01

Protecting the safety of blood transfusion is the top priority of transfusion service laboratories. Pretransfusion testing is a critical element of the entire transfusion process to enhance vein-to-vein safety. Human error associated with manual pretransfusion testing is a cause of transfusion-related mortality and morbidity and most human errors can be eliminated by automated systems. However, the uptake of automation in transfusion services has been slow and many transfusion service laboratories around the world still use manual blood group and antibody screen (G&S) methods. The goal of this study was to compare error potentials of commonly used manual (e.g., tiles and tubes) versus automated (e.g., ID-GelStation and AutoVue Innova) G&S methods. Routine G&S processes in seven transfusion service laboratories (four with manual and three with automated G&S methods) were analyzed using failure modes and effects analysis to evaluate the corresponding error potentials of each method. Manual methods contained a higher number of process steps ranging from 22 to 39, while automated G&S methods only contained six to eight steps. Corresponding to the number of the process steps that required human interactions, the risk priority number (RPN) of the manual methods ranged from 5304 to 10,976. In contrast, the RPN of the automated methods was between 129 and 436 and also demonstrated a 90% to 98% reduction of the defect opportunities in routine G&S testing. This study provided quantitative evidence on how automation could transform pretransfusion testing processes by dramatically reducing error potentials and thus would improve the safety of blood transfusion. © 2012 American Association of Blood Banks.

Demonstrating Hemostasis with a Student-Designed Prothrombin Time Test

ERIC Educational Resources Information Center

Fardy, Richard Wiley

1978-01-01

Describes a blood coagulation test developed by two high school biology students. Although the test lacks some precision, results indicate that the technique is comparable to standard methods used in laboratories. (MA)

The Daniel K. Inouye College of Pharmacy Scripts: Updates on Clostridium difficile Infection: Advances in Laboratory Testing to Aid Diagnosis and Treatment.

PubMed

Lteif, Louis

2017-02-01

Clostridium difficile remains a major source of nosocomial infections and associated diarrhea. More recently, community-acquired cases are on the rise creating a concern for a serious public health threat. Appropriate infection control precautions as well as prevention and optimal management may help to avoid detrimental outbreaks. A key step is utilizing laboratory testing for quick and accurate diagnosis of potential cases. This overview article describes Clostridium difficile infection control and prevention methods and updates the most recent management strategies including a focus on the utilization and interpretation of laboratory diagnostic testing and appropriate treatment.

Analytic Validation of Immunohistochemistry Assays: New Benchmark Data From a Survey of 1085 Laboratories.

PubMed

Stuart, Lauren N; Volmar, Keith E; Nowak, Jan A; Fatheree, Lisa A; Souers, Rhona J; Fitzgibbons, Patrick L; Goldsmith, Jeffrey D; Astles, J Rex; Nakhleh, Raouf E

2017-09-01

- A cooperative agreement between the College of American Pathologists (CAP) and the United States Centers for Disease Control and Prevention was undertaken to measure laboratories' awareness and implementation of an evidence-based laboratory practice guideline (LPG) on immunohistochemical (IHC) validation practices published in 2014. - To establish new benchmark data on IHC laboratory practices. - A 2015 survey on IHC assay validation practices was sent to laboratories subscribed to specific CAP proficiency testing programs and to additional nonsubscribing laboratories that perform IHC testing. Specific questions were designed to capture laboratory practices not addressed in a 2010 survey. - The analysis was based on responses from 1085 laboratories that perform IHC staining. Ninety-six percent (809 of 844) always documented validation of IHC assays. Sixty percent (648 of 1078) had separate procedures for predictive and nonpredictive markers, 42.7% (220 of 515) had procedures for laboratory-developed tests, 50% (349 of 697) had procedures for testing cytologic specimens, and 46.2% (363 of 785) had procedures for testing decalcified specimens. Minimum case numbers were specified by 85.9% (720 of 838) of laboratories for nonpredictive markers and 76% (584 of 768) for predictive markers. Median concordance requirements were 95% for both types. For initial validation, 75.4% (538 of 714) of laboratories adopted the 20-case minimum for nonpredictive markers and 45.9% (266 of 579) adopted the 40-case minimum for predictive markers as outlined in the 2014 LPG. The most common method for validation was correlation with morphology and expected results. Laboratories also reported which assay changes necessitated revalidation and their minimum case requirements. - Benchmark data on current IHC validation practices and procedures may help laboratories understand the issues and influence further refinement of LPG recommendations.

Laboratory assessment of novel oral anticoagulants: method suitability and variability between coagulation laboratories.

PubMed

Helin, Tuukka A; Pakkanen, Anja; Lassila, Riitta; Joutsi-Korhonen, Lotta

2013-05-01

Laboratory tests to assess novel oral anticoagulants (NOACs) are under evaluation. Routine monitoring is unnecessary, but under special circumstances bioactivity assessment becomes crucial. We analyzed the effects of NOACs on coagulation tests and the availability of specific assays at different laboratories. Plasma samples spiked with dabigatran (Dabi; 120 and 300 μg/L) or rivaroxaban (Riva; 60, 146, and 305 μg/L) were sent to 115 and 38 European laboratories, respectively. International normalized ratio (INR) and activated partial thromboplastin time (APTT) were analyzed for all samples; thrombin time (TT) was analyzed specifically for Dabi and calibrated anti-activated factor X (anti-Xa) activity for Riva. We compared the results with patient samples. Results of Dabi samples were reported by 73 laboratories (13 INR and 9 APTT reagents) and Riva samples by 22 laboratories (5 INR and 4 APTT reagents). Both NOACs increased INR values; the increase was modest, albeit larger, for Dabi, with higher CV, especially with Quick (vs Owren) methods. Both NOACs dose-dependently prolonged the APTT. Again, the prolongation and CVs were larger for Dabi. The INR and APTT results varied reagent-dependently (P < 0.005), with less prolongation in patient samples. TT results (Dabi) and calibrated anti-Xa results (Riva) were reported by only 11 and 8 laboratories, respectively. The screening tests INR and APTT are suboptimal in assessing NOACs, having high reagent dependence and low sensitivity and specificity. They may provide information, if laboratories recognize their limitations. The variation will likely increase and the sensitivity differ in clinical samples. Specific assays measure NOACs accurately; however, few laboratories applied them. © 2013 American Association for Clinical Chemistry.

Emerging Technologies for the Clinical Microbiology Laboratory

PubMed Central

Buchan, Blake W.

2014-01-01

SUMMARY In this review we examine the literature related to emerging technologies that will help to reshape the clinical microbiology laboratory. These topics include nucleic acid amplification tests such as isothermal and point-of-care molecular diagnostics, multiplexed panels for syndromic diagnosis, digital PCR, next-generation sequencing, and automation of molecular tests. We also review matrix-assisted laser desorption ionization–time of flight (MALDI-TOF) and electrospray ionization (ESI) mass spectrometry methods and their role in identification of microorganisms. Lastly, we review the shift to liquid-based microbiology and the integration of partial and full laboratory automation that are beginning to impact the clinical microbiology laboratory. PMID:25278575

Comparison of results of fluconazole disk diffusion testing for Candida species with results from a central reference laboratory in the ARTEMIS global antifungal surveillance program.

PubMed

Pfaller, M A; Hazen, K C; Messer, S A; Boyken, L; Tendolkar, S; Hollis, R J; Diekema, D J

2004-08-01

The accuracy of antifungal susceptibility tests is important for accurate resistance surveillance and for the clinical management of patients with serious infections. Our main objective was to compare the results of fluconazole disk diffusion testing of Candida spp. performed by ARTEMIS participating centers with disk diffusion and MIC results obtained by the central reference laboratory. A total of 2,949 isolates of Candida spp. were tested by NCCLS disk diffusion and reference broth microdilution methods in the central reference laboratory. These results were compared to the results of disk diffusion testing performed in the 54 participating centers. All tests were performed and interpreted following NCCLS recommendations. Overall categorical agreement between participant disk diffusion test results and reference laboratory MIC results was 87.4%, with 0.2% very major errors (VME) and 3.3% major errors (ME). The categorical agreement between the disk diffusion test results obtained in the reference laboratory with the MIC test results was similar: 92.8%. Likewise, good agreement was observed between participant disk diffusion test results and reference laboratory disk diffusion test results: 90.4%, 0.4% VME, and 3.4% ME. The disk diffusion test was especially reliable in detecting those isolates of Candida spp. that were characterized as resistant by reference MIC testing. External quality assurance data obtained by surveillance programs such as the ARTEMIS Global Antifungal Surveillance Program ensure the generation of useful surveillance data and result in the continued improvement of antifungal susceptibility testing practices.

Comparison of the diagnostic accuracy of a rapid immunochromatographic test and the rapid plasma reagin test for antenatal syphilis screening in Mozambique.

PubMed Central

Montoya, Pablo J.; Lukehart, Sheila A.; Brentlinger, Paula E.; Blanco, Ana J.; Floriano, Florencia; Sairosse, Josefa; Gloyd, Stephen

2006-01-01

OBJECTIVE: Programmes to control syphilis in developing countries are hampered by a lack of laboratory services, delayed diagnosis, and doubts about current screening methods. We aimed to compare the diagnostic accuracy of an immunochromatographic strip (ICS) test and the rapid plasma reagin (RPR) test with the combined gold standard (RPR, Treponema pallidum haemagglutination assay and direct immunofluorescence stain done at a reference laboratory) for the detection of syphilis in pregnancy. METHODS: We included test results from 4789 women attending their first antenatal visit at one of six health facilities in Sofala Province, central Mozambique. We compared diagnostic accuracy (sensitivity, specificity, and positive and negative predictive values) of ICS and RPR done at the health facilities and ICS performed at the reference laboratory. We also made subgroup comparisons by human immunodeficiency virus (HIV) and malaria status. FINDINGS: For active syphilis, the sensitivity of the ICS was 95.3% at the reference laboratory, and 84.1% at the health facility. The sensitivity of the RPR at the health facility was 70.7%. Specificity and positive and negative predictive values showed a similar pattern. The ICS outperformed RPR in all comparisons (P<0.001). CONCLUSION: The diagnostic accuracy of the ICS compared favourably with that of the gold standard. The use of the ICS in Mozambique and similar settings may improve the diagnosis of syphilis in health facilities, both with and without laboratories. PMID:16501726

Using an interlaboratory study to revise methods for conducting 10-d to 42-d water or sediment toxicity tests with Hyalella azteca

USGS Publications Warehouse

Ivey, Chris D.; Ingersoll, Christopher G.; Brumbaugh, William G.; Hammer, Edward J.; Mount, David R.; Hockett, J. Russell; Norberg-King, Teresa J.; Soucek, Dave; Taylor, Lisa

2016-01-01

Studies have been conducted to refine US Environmental Protection Agency, ASTM International, and Environment Canada standard methods for conducting 42-d reproduction tests with Hyalella azteca in water or in sediment. Modifications to the H. azteca method include better-defined ionic composition requirements for exposure water (i.e., >15 mg/L of chloride and >0.02 mg/L of bromide) and improved survival, growth, and reproduction with alternate diets provided as increased rations over time in water-only or whole-sediment toxicity tests. A total of 24 laboratories volunteered to participate in the present interlaboratory study evaluating the performance of H. azteca in 42-d studies in control sand or control sediment using the refined methods. Improved growth and reproduction of H. azteca was observed with 2 alternate diets of 1) ramped diatoms (Thalassiosira weissflogii) + ramped Tetramin or 2) yeast–cerophyll–trout chow (YCT) + ramped Tetramin, especially when compared with results from the traditional diet of 1.8 mg YCT/d. Laboratories were able to meet proposed test acceptability criteria and in most cases had lower variation in growth or reproduction compared with previous interlaboratory studies using the traditional YCT diet. Laboratory success in conducting 42-d H. azteca exposures benefited from adherence to several key requirements of the detailed testing, culturing, and handling methods. Results from the present interlaboratory study are being used to help revise standard methods for conducting 10-d to 42-d water or sediment toxicity exposures with H. azteca.

Comparison of HbA1c Measurements using 3 Methods in 75 Patients Referred to One Outpatient Department.

PubMed

Roth, Johannes; Müller, Nicolle; Lehmann, Thomas; Böer, Klas; Löbel, Sven; Pum, Joachim; Müller, Ulrich Alfons

2018-01-01

HbA 1c is the most important surrogate parameter to assess the quality of diabetes care and is also used for the diagnosis of diabetes mellitus (DM) since 2010. We investigated the comparability of 3 HbA 1c methods in the city of Jena (Germany). The HbA 1c determination was carried out in 50 healthy subjects and 24 people with DM (age 51.2±16.3 years, HbA 1c 6.8±2.2%) with 3 different hemoglobin A 1c testing methods at 4 locations in one city. Our laboratory (HPLC method) served as a reference for comparing the results. All methods are IFCC standardized and all devices are certified by the interlaboratory test. The mean HbA 1c of people without diabetes was: laboratory A (TOSOH G8, HPLC) 5.7±0.3%; laboratory B (TOSOH G8, HPLC) 5.5±0.3%, laboratory C (VARIANT II) 5.2±0.3%; laboratory D (COBAS INT.) 5.6±0.3%. All differences are significant (p=0.001).The mean HbA 1c of patients with mild to moderate elevated HbA 1c was: Laboratory A 7.5±0.9%; B 7.3±1.0%; C 7.0±0.9%; D 7.5±1.1%. Differences are significant (p=0.001) except between laboratory A and D (p=0.8).The mean HbA 1c of patients with massively increased HbA 1c was: laboratory A 11.5±1.8%; laboratory B 11.4±1.8%; laboratory C 10.8±1.6%; laboratory D 11.5±1.5%. Differences between laboratory A and C, as well as between C and D were significant (p=0.001). The mean IFCC standardized HbA 1c from 75 people differs by up to 0.5% absolute between 4 laboratories. This difference is clinically significant and may lead to misdiagnosis and wrong treatment decisions, while HbA 1c value from one patient were analyzed in different laboratories within a short time. © Georg Thieme Verlag KG Stuttgart · New York.

Teaching Analytical Method Transfer through Developing and Validating Then Transferring Dissolution Testing Methods for Pharmaceuticals

ERIC Educational Resources Information Center

Kimaru, Irene; Koether, Marina; Chichester, Kimberly; Eaton, Lafayette

2017-01-01

Analytical method transfer (AMT) and dissolution testing are important topics required in industry that should be taught in analytical chemistry courses. Undergraduate students in senior level analytical chemistry laboratory courses at Kennesaw State University (KSU) and St. John Fisher College (SJFC) participated in development, validation, and…

A MULTI-LABORATORY EVALUATION OF METHODS FOR DETECTING ENTERIC VIRUSES IN SOILS

EPA Science Inventory

Two candidate methods for the recovery and detection of viruses in soil were subjected to round robin comparative testing by members of the American Society for Testing and Materials D19:24:04:04 Subcommittee Task Group. Selection of the methods, designated “Berg” and “Goyal,” wa...

Ring trial among National Reference Laboratories for parasites to detect Trichinella spiralis larvae in pork samples according to the EU directive 2075/2005.

PubMed

Marucci, Gianluca; Pezzotti, Patrizio; Pozio, Edoardo

2009-02-23

To control Trichinella spp. infection in the European Union, all slaughtered pigs should be tested by one of the approved digestion methods described in EU directive 2075/2005. The aim of the present work was to evaluate, by a ring trial, the sensitivity of the digestion method used at the National Reference Laboratories for Parasites (NRLP). These Laboratories are responsible for the quality of the detection method in their own country. Of the 27 EU countries, only three (Hungary, Luxembourg and Malta) did not participate in the ring trial. Each participating laboratory received 10 samples of 100g of minced pork containing 3-5 larvae (3 samples), 10-20 larvae (3 samples), 30-50 larvae (3 samples), and one negative control. In each positive sample, there were living Trichinella spiralis larvae without the collagen capsule, obtained by partial artificial digestion of muscle tissue from infected mice. No false positive sample was found in any laboratories, whereas nine laboratories (37.5%) failed to detect some positive samples with the percentage of false negatives ranging from 11 to 100%. The variation between expected and reported larval counts observed among the participating laboratories was statistically significant. There was a direct correlation between the consistency of the results and the use of a validated/accredited digestion method. Conversely, there was no correlation between the consistency of the results and the number of digestions performed yearly by the NRLP. These results support the importance of validating the test.

Evaluation of the Illumigene Malaria LAMP: A Robust Molecular Diagnostic Tool for Malaria Parasites

PubMed Central

Lucchi, Naomi W.; Gaye, Marie; Diallo, Mammadou Alpha; Goldman, Ira F.; Ljolje, Dragan; Deme, Awa Bineta; Badiane, Aida; Ndiaye, Yaye Die; Barnwell, John W.; Udhayakumar, Venkatachalam; Ndiaye, Daouda

2016-01-01

Isothermal nucleic acid amplification assays such as the loop mediated isothermal amplification (LAMP), are well suited for field use as they do not require thermal cyclers to amplify the DNA. To further facilitate the use of LAMP assays in remote settings, simpler sample preparation methods and lyophilized reagents are required. The performance of a commercial malaria LAMP assay (Illumigene Malaria LAMP) was evaluated using two sample preparation workflows (simple filtration prep (SFP)) and gravity-driven filtration prep (GFP)) and pre-dispensed lyophilized reagents. Laboratory and clinical samples were tested in a field laboratory in Senegal and the results independently confirmed in a reference laboratory in the U.S.A. The Illumigene Malaria LAMP assay was easily implemented in the clinical laboratory and gave similar results to a real-time PCR reference test with limits of detection of ≤2.0 parasites/μl depending on the sample preparation method used. This assay reliably detected Plasmodium sp. parasites in a simple low-tech format, providing a much needed alternative to the more complex molecular tests for malaria diagnosis. PMID:27827432

Research on air sprays and unique foam application methods. Phase II report. Laboratory investigation of foam systems

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

Not Available

1982-06-01

The objective of this study is to assess the effectiveness of air sprays and foam systems for dust control on longwall double-drum shearer faces. Laboratory testing has been conducted using foam systems and promising results have been obtained. Upon Bureau approval, underground testing will be scheduled to assess the effectiveness of foam systems under actual operating conditions. Laboratory testing of air sprays is being conducted at present. This report presents the results of the laboratory testing of foam systems. Specifically, the results obtained on the evaluation of selected foaming agents are presented, the feasibility investigation of flushing foam through themore » shearer-drum are demonstrated, and conceptual layout of the foam system on the shearer is discussed. The laboratory investigation of the selected foaming agents reveal that the Onyx Microfoam, Onyx Maprosyl and DeTer Microfoam foaming agents have higher expansion ratios compared to the others tested. Flushing foam through the shearer drum is entirely feasible and could be a viable technique for dust suppression on longwall faces.« less

Validation of pharmaceutical potency determinations by quantitative nuclear magnetic resonance spectrometry.

PubMed

Webster, Gregory K; Marsden, Ian; Pommerening, Cynthia A; Tyrakowski, Christina M

2010-05-01

With the changing development paradigms in the pharmaceutical industry, laboratories are challenged to release materials for clinical studies with rapid turnaround times. To minimize cost demands, many businesses are looking to develop ways of using early Good Manufacturing Practice (GMP) materials of active pharmaceutical ingredients (API) for Good Laboratory Practice (GLP) toxicology studies. To make this happen, the analytical laboratory releases the material by one of three scenarios: (1) holding the GLP release until full GMP testing is ready, (2) issuing a separate lot number for a portion of the GMP material and releasing the material for GLP use, or (3) releasing the lot of material for GLP using alternate (equivalent) method(s) not specified for GMP release testing. Many companies are finding the third scenario to be advantageous in terms of cost and efficiency through the use of quantitative nuclear magnetic resonance (q-NMR). The use of q-NMR has proved to be a single-point replacement for routine early development testing that previously combined elements of identity testing, chromatographic assay, moisture analysis, residual solvent analysis, and elemental analysis. This study highlights that q-NMR can be validated to meet current regulatory analytical method guidelines for routine pharmaceutical analysis.

Interlaboratory comparison for the determination of the soluble fraction of metals in welding fume samples.

PubMed

Berlinger, Balazs; Harper, Martin

2018-02-01

There is interest in the bioaccessible metal components of aerosols, but this has been minimally studied because standardized sampling and analytical methods have not yet been developed. An interlaboratory study (ILS) has been carried out to evaluate a method for determining the water-soluble component of realistic welding fume (WF) air samples. Replicate samples were generated in the laboratory and distributed to participating laboratories to be analyzed according to a standardized procedure. Within-laboratory precision of replicate sample analysis (repeatability) was very good. Reproducibility between laboratories was not as good, but within limits of acceptability for the analysis of typical aerosol samples. These results can be used to support the development of a standardized test method.

Evaluation of a bioluminescence method, contact angle measurements and topography for testing the cleanability of plastic surfaces under laboratory conditions

NASA Astrophysics Data System (ADS)

Redsven, I.; Kymäläinen, H.-R.; Pesonen-Leinonen, E.; Kuisma, R.; Ojala-Paloposki, T.; Hautala, M.; Sjöberg, A.-M.

2007-04-01

Detection of adenosine triphosphate (ATP) by bioluminescence is used, for instance, in the food industry and in hospitals to assess the hygiene status of surfaces. The aim of this laboratory study was to investigate the feasibility of the ATP method for estimating the cleanability of resilient floor coverings from biological soil. The surfaces were worn using a Soiling and Wearing Drum Tester, and soiled and cleaned with an Erichsen Washability and Scrubbing Resistance Tester. In the laboratory test carried out with the bioluminescence method, most of the new and worn floor coverings that were biologically soiled were cleaned efficiently. According to this study, the semiquantitative ATP screening method can be used for hygiene monitoring of flooring materials. No correlation was found between cleanability and contact angles or surface topography measured using a profilometer. However, by revealing local irregularities and damage on surfaces, scanning electron micrographs appeared useful in explaining differences in cleanability.

Interlaboratory study of a liquid chromatography method for erythromycin: determination of uncertainty.

PubMed

Dehouck, P; Vander Heyden, Y; Smeyers-Verbeke, J; Massart, D L; Marini, R D; Chiap, P; Hubert, Ph; Crommen, J; Van de Wauw, W; De Beer, J; Cox, R; Mathieu, G; Reepmeyer, J C; Voigt, B; Estevenon, O; Nicolas, A; Van Schepdael, A; Adams, E; Hoogmartens, J

2003-08-22

Erythromycin is a mixture of macrolide antibiotics produced by Saccharopolyspora erythreas during fermentation. A new method for the analysis of erythromycin by liquid chromatography has previously been developed. It makes use of an Astec C18 polymeric column. After validation in one laboratory, the method was now validated in an interlaboratory study. Validation studies are commonly used to test the fitness of the analytical method prior to its use for routine quality testing. The data derived in the interlaboratory study can be used to make an uncertainty statement as well. The relationship between validation and uncertainty statement is not clear for many analysts and there is a need to show how the existing data, derived during validation, can be used in practice. Eight laboratories participated in this interlaboratory study. The set-up allowed the determination of the repeatability variance, s(2)r and the between-laboratory variance, s(2)L. Combination of s(2)r and s(2)L results in the reproducibility variance s(2)R. It has been shown how these data can be used in future by a single laboratory that wants to make an uncertainty statement concerning the same analysis.

Childhood lead poisoning investigations: evaluating a portable instrument for testing soil lead.

PubMed

Reames, Ginger; Lance, Larrie L

2002-04-01

The Childhood Lead Poisoning Prevention Branch of the California Department of Health Services evaluated a portable X-ray fluorescence (XRF) instrument for use as a soil lead-testing tool during environmental investigations of lead-poisoned children's homes. A Niton XRF was used to test soil at 119 sampling locations in the yards of 11 San Francisco Bay Area houses. Niton XRF readings were highly correlated with laboratory results and met the study criteria for an acceptable screening method. The data suggest that the most health-protective and time-efficient approach to testing for soil lead above regulatory levels is to take either surface readings or readings of a test cup of soil prepared by grinding with a mortar and pestle. The advantage of the test cup method is that the test cup with soil may be submitted to a laboratory for confirmatory analysis.

Forensic analysis of explosives using isotope ratio mass spectrometry (IRMS)--part 2: forensic inter-laboratory trial: bulk carbon and nitrogen stable isotopes in a range of chemical compounds (Australia and New Zealand).

PubMed

Benson, Sarah J; Lennard, Christopher J; Maynard, Philip; Hill, David M; Andrew, Anita S; Neal, Ken; Stuart-Williams, Hilary; Hope, Janet; Walker, G Stewart; Roux, Claude

2010-01-01

Comparability of data over time and between laboratories is a key issue for consideration in the development of global databases, and more broadly for quality assurance in general. One mechanism that can be utilized for evaluating traceability is an inter-laboratory trial. This paper addresses an inter-laboratory trial conducted across a number of Australian and New Zealand isotope ratio mass spectrometry (IRMS) laboratories. The main objective of this trial was to determine whether IRMS laboratories in these countries would record comparable values for the distributed samples. Four carbon containing and four nitrogen containing compounds were distributed to seven laboratories in Australia and one in New Zealand. The laboratories were requested to analyze the samples using their standard procedures. The data from each laboratory was evaluated collectively using International Standard ISO 13528 (Statistical methods for use in proficiency testing by inter-laboratory comparisons). "Warning signals" were raised against one participant in this trial. "Action signals" requiring corrective action were raised against four participants. These participants reviewed the data and possible sources for the discrepancies. This inter-laboratory trial was successful in providing an initial snapshot of the potential for traceability between the participating laboratories. The statistical methods described in this article could be used as a model for others needing to evaluate stable isotope results derived from multiple laboratories, e.g., inter-laboratory trials/proficiency testing. Ongoing trials will be conducted to improve traceability across the Australian and New Zealand IRMS community.

SRC-I demonstration plant analytical laboratory methods manual. Final technical report

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

Klusaritz, M.L.; Tewari, K.C.; Tiedge, W.F.

1983-03-01

This manual is a compilation of analytical procedures required for operation of a Solvent-Refined Coal (SRC-I) demonstration or commercial plant. Each method reproduced in full includes a detailed procedure, a list of equipment and reagents, safety precautions, and, where possible, a precision statement. Procedures for the laboratory's environmental and industrial hygiene modules are not included. Required American Society for Testing and Materials (ASTM) methods are cited, and ICRC's suggested modifications to these methods for handling coal-derived products are provided.

Evaluation of new aquatic toxicity test methods for oil dispersants

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

Pace, C.B.; Clark, J.R.; Bragin, G.E.

1994-12-31

Current aquatic toxicity test methods used for dispersant registration do not address real world exposure scenarios. Current test methods require 48 or 96 hour constant exposure conditions. In contrast, environmentally realistic exposures can be described as a pulse in which the initial concentration declines over time. Recent research using a specially designed testing apparatus (the California system) has demonstrated that exposure to Corexit 9527{reg_sign} under pulsed exposure conditions may be 3 to 22 times less toxic compared to continuous exposure scenarios. The objectives of this study were to compare results of toxicity tests using the California test system to resultsmore » from standardized tests, evaluate sensitivity of regional (Holmesimysis cast and Atherinops affinis) vs. standard test species (Mysidopsis bahia and Menidia beryllina) and determine if tests using the California test system and method are reproducible. All tests were conducted using Corexit 9527{reg_sign} as the test material. Standard toxicity tests conducted with M. bahia and H. cast resulted in LC50s similar to those from tests using the California apparatus. LC50s from tests conducted in the authors` laboratory with the California system and standard test species were within a factor of 2 to 6 of data previously reported for west coast species. Results of tests conducted with H. cast in the laboratory compared favorably to data reported by Singer et al. 1991.« less

Laboratory Capacity for Antimicrobial Susceptibility Surveillance of Neisseria gonorrhoeae-District of Columbia, 2007-2012.

PubMed

Garrett, Tiana A; Davies-Cole, John; Furness, Bruce

2015-08-01

In the District of Columbia (DC), Neisseria gonorrhoeae (gonorrhea) infections accounted for more than 25% of 9321 incident sexually transmitted infections reported in 2011; untreated infections can lead to reproductive complications and a higher risk for HIV transmission. In DC, limited capacity to measure the prevalence of antibiotic-resistant N. gonorrhoeae is available; culture-based antibiotic susceptibility testing (AST) is needed to monitor antimicrobial resistance. We examined the capacity of laboratories that report to the DC Department of Health to perform AST for ongoing surveillance of antibiotic-resistant N. gonorrhoeae and to identify suspected treatment failures. We created a survey about diagnostic methods for gonorrhea testing and identified 33 laboratories that reported gonorrhea results to Department of Health in 2007 to 2012. Laboratories were assessed for use of bacterial culture or nucleic acid amplification testing (NAAT) for gonorrhea testing, prevalence of AST on gonorrhea-positive cultures, and types of antibiotics tested during AST. We estimated the prevalence of laboratory practices on the basis of self-report by staff. Nineteen (58%) laboratories completed the survey, representing 92% of the gonorrhea reporting. Seventeen (89%) of 19 laboratories conducted testing by culture; only 6 (35%) performed AST; 79% performed NAAT. Barriers to AST included longer completion times and limited number of provider requests for AST. Commercial laboratories (32%) were more likely to conduct both culture and NAAT, compared with health care facilities (11%). We report a low prevalence of laboratories performing AST because of multiple barriers. State-specific strategies addressing these barriers are needed to improve detection of antibiotic-resistant gonorrhea stains circulating among the population.

A comparison of two microscale laboratory reporting methods in a secondary chemistry classroom

NASA Astrophysics Data System (ADS)

Martinez, Lance Michael

This study attempted to determine if there was a difference between the laboratory achievement of students who used a modified reporting method and those who used traditional laboratory reporting. The study also determined the relationships between laboratory performance scores and the independent variables score on the Group Assessment of Logical Thinking (GALT) test, chronological age in months, gender, and ethnicity for each of the treatment groups. The study was conducted using 113 high school students who were enrolled in first-year general chemistry classes at Pueblo South High School in Colorado. The research design used was the quasi-experimental Nonequivalent Control Group Design. The statistical treatment consisted of the Multiple Regression Analysis and the Analysis of Covariance. Based on the GALT, students in the two groups were generally in the concrete and transitional stages of the Piagetian cognitive levels. The findings of the study revealed that the traditional and the modified methods of laboratory reporting did not have any effect on the laboratory performance outcome of the subjects. However, the students who used the traditional method of reporting showed a higher laboratory performance score when evaluation was conducted using the New Standards rubric recommended by the state. Multiple Regression Analysis revealed that there was a significant relationship between the criterion variable student laboratory performance outcome of individuals who employed traditional laboratory reporting methods and the composite set of predictor variables. On the contrary, there was no significant relationship between the criterion variable student laboratory performance outcome of individuals who employed modified laboratory reporting methods and the composite set of predictor variables.

Recommendations for Filler Material Composition and Delivery Method for Bench-Scale Testing

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

Hardin, Ernest; Brady, Patrick Vane

This report supplements Joint Workplan on Filler Investigations for DPCs (SNL 2017) providing new and some corrected information for use in planning Phase 1 laboratory testing of slurry cements as possible DPC fillers. The scope description is to "Describe a complete laboratory testing program for filler composition, delivery, emplacement in surrogate canisters, and post-test examination. To the extent possible specify filler material and equipment sources." This report includes results from an independent expert review (Dr. Arun Wagh, retired from Argonne National Laboratory and contracted by Sandia) that helped to narrow the range of cement types for consideration, and to providemore » further guidance on mix variations to optimize injectability, durability, and other aspects of filler performance.« less

Medical microbiology: laboratory diagnosis of invasive pneumococcal disease.

PubMed

Werno, Anja M; Murdoch, David R

2008-03-15

The laboratory diagnosis of invasive pneumococcal disease (IPD) continues to rely on culture-based methods that have been used for many decades. The most significant recent developments have occurred with antigen detection assays, whereas the role of nucleic acid amplification tests has yet to be fully clarified. Despite developments in laboratory diagnostics, a microbiological diagnosis is still not made in most cases of IPD, particularly for pneumococcal pneumonia. The limitations of existing diagnostic tests impact the ability to obtain accurate IPD burden data and to assess the effectiveness of control measures, such as vaccination, in addition to the ability to diagnose IPD in individual patients. There is an urgent need for improved diagnostic tests for pneumococcal disease--especially tests that are suitable for use in underresourced countries.

Field assessment of dried Plasmodium falciparum samples for malaria rapid diagnostic test quality control and proficiency testing in Ethiopia.

PubMed

Tamiru, Afework; Boulanger, Lucy; Chang, Michelle A; Malone, Joseph L; Aidoo, Michael

2015-01-21

Rapid diagnostic tests (RDTs) are now widely used for laboratory confirmation of suspected malaria cases to comply with the World Health Organization recommendation for universal testing before treatment. However, many malaria programmes lack quality control (QC) processes to assess RDT use under field conditions. Prior research showed the feasibility of using the dried tube specimen (DTS) method for preserving Plasmodium falciparum parasites for use as QC samples for RDTs. This study focused on the use of DTS for RDT QC and proficiency testing under field conditions. DTS were prepared using cultured P. falciparum at densities of 500 and 1,000 parasites/μL; 50 μL aliquots of these along with parasite negative human blood controls (0 parasites/μL) were air-dried in specimen tubes and reactivity verified after rehydration. The DTS were used in a field study in the Oromia Region of Ethiopia. Replicate DTS samples containing 0, 500 and 1,000 parasites/μL were stored at 4°C at a reference laboratory and at ambient temperatures at two nearby health facilities. At weeks 0, 4, 8, 12, 16, 20, and 24, the DTS were rehydrated and tested on RDTs stored under manufacturer-recommended temperatures at the RL and on RDTs stored under site-specific conditions at the two health facilities. Reactivity of DTS stored at 4°C at the reference laboratory on RDTs stored at the reference laboratory was considered the gold standard for assessing DTS stability. A proficiency-testing panel consisting of one negative and three positive samples, monitored with a checklist was administered at weeks 12 and 24. At all the seven time points, DTS stored at both the reference laboratory and health facility were reactive on RDTs stored under the recommended temperature and under field conditions, and the DTS without malaria parasites were negative. At the reference laboratory and one health facility, a 500 parasites/μL DTS from the proficiency panel was falsely reported as negative at week 24 due to errors in interpreting faint test lines. The DTS method can be used under field conditions to supplement other RDT QC methods and health worker proficiency in Ethiopia and possibly other malaria-endemic countries.

Development of a Fan-Filter Unit Test Standard, LaboratoryValidations, and its Applications across Industries

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

Xu, Tengfang

2006-10-20

Lawrence Berkeley National Laboratory (LBNL) is now finalizing the Phase 2 Research and Demonstration Project on characterizing 2-foot x 4-foot (61-cm x 122-cm) fan-filter units in the market using the first-ever standard laboratory test method developed at LBNL.[1][2][3] Fan-filter units deliver re-circulated air and provide particle filtration control for clean environments. Much of the energy in cleanrooms (and minienvironments) is consumed by 2-foot x 4-foot (61-cm x 122-cm) or 4-foot x 4-foot (122-cm x 122-cm) fan-filter units that are typically located in the ceiling (25-100% coverage) of cleanroom controlled environments. Thanks to funding support by the California Energy Commission's Industrialmore » Program of the Public Interest Energy Research (PIER) Program, and significant participation from manufacturers and users of fan-filter units from around the world, LBNL has developed and performed a series of standard laboratory tests and reporting on a variety of 2-foot x 4-foot (61-cm x 122-cm) fan-filter units (FFUs). Standard laboratory testing reports have been completed and reported back to anonymous individual participants in this project. To date, such reports on standard testing of FFU performance have provided rigorous and useful data for suppliers and end users to better understand, and more importantly, to quantitatively characterize performance of FFU products under a variety of operating conditions.[1] In the course of the project, the standard laboratory method previously developed at LBNL has been under continuous evaluation and update.[2][3] Based upon the updated standard, it becomes feasible for users and suppliers to characterize and evaluate energy performance of FFUs in a consistent way.« less

Open-source Software for Demand Forecasting of Clinical Laboratory Test Volumes Using Time-series Analysis

PubMed Central

Mohammed, Emad A.; Naugler, Christopher

2017-01-01

Background: Demand forecasting is the area of predictive analytics devoted to predicting future volumes of services or consumables. Fair understanding and estimation of how demand will vary facilitates the optimal utilization of resources. In a medical laboratory, accurate forecasting of future demand, that is, test volumes, can increase efficiency and facilitate long-term laboratory planning. Importantly, in an era of utilization management initiatives, accurately predicted volumes compared to the realized test volumes can form a precise way to evaluate utilization management initiatives. Laboratory test volumes are often highly amenable to forecasting by time-series models; however, the statistical software needed to do this is generally either expensive or highly technical. Method: In this paper, we describe an open-source web-based software tool for time-series forecasting and explain how to use it as a demand forecasting tool in clinical laboratories to estimate test volumes. Results: This tool has three different models, that is, Holt-Winters multiplicative, Holt-Winters additive, and simple linear regression. Moreover, these models are ranked and the best one is highlighted. Conclusion: This tool will allow anyone with historic test volume data to model future demand. PMID:28400996

National and international veterinary reference laboratories for infectious diseases.

PubMed

Edwards, S; Alexander, D

1998-08-01

Reference laboratories play an increasingly important role in the harmonisation of laboratory diagnostic tests and the standardisation of veterinary vaccines. This is particularly important in building confidence between international trading partners. The authors review aspects of the organisation, designation and support of reference laboratories for infectious diseases of animals and discuss the principal activities which such laboratories would normally perform. These activities include advice and consultancy, publications and communication, training, research, disease surveillance, maintenance of culture collections, evaluation of reference methods, preparation of reference materials and organisation of inter-laboratory comparisons.

Errors in clinical laboratories or errors in laboratory medicine?

PubMed

Plebani, Mario

2006-01-01

Laboratory testing is a highly complex process and, although laboratory services are relatively safe, they are not as safe as they could or should be. Clinical laboratories have long focused their attention on quality control methods and quality assessment programs dealing with analytical aspects of testing. However, a growing body of evidence accumulated in recent decades demonstrates that quality in clinical laboratories cannot be assured by merely focusing on purely analytical aspects. The more recent surveys on errors in laboratory medicine conclude that in the delivery of laboratory testing, mistakes occur more frequently before (pre-analytical) and after (post-analytical) the test has been performed. Most errors are due to pre-analytical factors (46-68.2% of total errors), while a high error rate (18.5-47% of total errors) has also been found in the post-analytical phase. Errors due to analytical problems have been significantly reduced over time, but there is evidence that, particularly for immunoassays, interference may have a serious impact on patients. A description of the most frequent and risky pre-, intra- and post-analytical errors and advice on practical steps for measuring and reducing the risk of errors is therefore given in the present paper. Many mistakes in the Total Testing Process are called "laboratory errors", although these may be due to poor communication, action taken by others involved in the testing process (e.g., physicians, nurses and phlebotomists), or poorly designed processes, all of which are beyond the laboratory's control. Likewise, there is evidence that laboratory information is only partially utilized. A recent document from the International Organization for Standardization (ISO) recommends a new, broader definition of the term "laboratory error" and a classification of errors according to different criteria. In a modern approach to total quality, centered on patients' needs and satisfaction, the risk of errors and mistakes in pre- and post-examination steps must be minimized to guarantee the total quality of laboratory services.

Literature review : an analysis of laboratory fatigue tests.

DOT National Transportation Integrated Search

1975-01-01

This report discusses the various types of fatigue tests, grouped by the type of specimen (beam, plate, Marshall, etc.) used. The discussion under each type of specimen covers the test, and the analytical methods used in evaluating the data. The test...

Can vaccinia virus be replaced by MVA virus for testing virucidal activity of chemical disinfectants?

PubMed

Rabenau, Holger F; Rapp, Ingrid; Steinmann, Jochen

2010-06-23

Vaccinia virus strain Lister Elstree (VACV) is a test virus in the DVV/RKI guidelines as representative of the stable enveloped viruses. Since the potential risk of laboratory-acquired infections with VACV persists and since the adverse effects of vaccination with VACV are described, the replacement of VACV by the modified vaccinia Ankara strain (MVA) was studied by testing the activity of different chemical biocides in three German laboratories. The inactivating properties of different chemical biocides (peracetic acid, aldehydes and alcohols) were tested in a quantitative suspension test according to the DVV/RKI guideline. All tests were performed with a protein load of 10% fetal calf serum with both viruses in parallel using different concentrations and contact times. Residual virus was determined by endpoint dilution method. The chemical biocides exhibited similar virucidal activity against VACV and MVA. In three cases intra-laboratory differences were determined between VACV and MVA - 40% (v/v) ethanol and 30% (v/v) isopropanol are more active against MVA, whereas MVA seems more stable than VACV when testing with 0.05% glutardialdehyde. Test accuracy across the three participating laboratories was high. Remarkably inter-laboratory differences in the reduction factor were only observed in two cases. Our data provide valuable information for the replacement of VACV by MVA for testing chemical biocides and disinfectants. Because MVA does not replicate in humans this would eliminate the potential risk of inadvertent inoculation with vaccinia virus and disease in non-vaccinated laboratory workers.

Musk as a Pheromone? Didactic Exercise.

ERIC Educational Resources Information Center

Bersted, Chris T.

A classroom/laboratory exercise has been used to introduce college students to factorial research designs, differentiate between interpretations for experimental and quasi-experimental variables, and exemplify application of laboratory research methods to test practical questions (advertising claims). The exercise involves having randomly divided…

Validation of a modification to Performance-Tested Method 070601: Reveal Listeria Test for detection of Listeria spp. in selected foods and selected environmental samples.

PubMed

Alles, Susan; Peng, Linda X; Mozola, Mark A

2009-01-01

A modification to Performance-Tested Method (PTM) 070601, Reveal Listeria Test (Reveal), is described. The modified method uses a new media formulation, LESS enrichment broth, in single-step enrichment protocols for both foods and environmental sponge and swab samples. Food samples are enriched for 27-30 h at 30 degrees C and environmental samples for 24-48 h at 30 degrees C. Implementation of these abbreviated enrichment procedures allows test results to be obtained on a next-day basis. In testing of 14 food types in internal comparative studies with inoculated samples, there was a statistically significant difference in performance between the Reveal and reference culture [U.S. Food and Drug Administration's Bacteriological Analytical Manual (FDA/BAM) or U.S. Department of Agriculture-Food Safety and Inspection Service (USDA-FSIS)] methods for only a single food in one trial (pasteurized crab meat) at the 27 h enrichment time point, with more positive results obtained with the FDA/BAM reference method. No foods showed statistically significant differences in method performance at the 30 h time point. Independent laboratory testing of 3 foods again produced a statistically significant difference in results for crab meat at the 27 h time point; otherwise results of the Reveal and reference methods were statistically equivalent. Overall, considering both internal and independent laboratory trials, sensitivity of the Reveal method relative to the reference culture procedures in testing of foods was 85.9% at 27 h and 97.1% at 30 h. Results from 5 environmental surfaces inoculated with various strains of Listeria spp. showed that the Reveal method was more productive than the reference USDA-FSIS culture procedure for 3 surfaces (stainless steel, plastic, and cast iron), whereas results were statistically equivalent to the reference method for the other 2 surfaces (ceramic tile and sealed concrete). An independent laboratory trial with ceramic tile inoculated with L. monocytogenes confirmed the effectiveness of the Reveal method at the 24 h time point. Overall, sensitivity of the Reveal method at 24 h relative to that of the USDA-FSIS method was 153%. The Reveal method exhibited extremely high specificity, with only a single false-positive result in all trials combined for overall specificity of 99.5%.

Update on the College of American Pathologists Experience With High-Risk Human Papillomavirus Proficiency Testing for Cytology.

PubMed

Ghofrani, Mohiedean; Zhao, Chengquan; Davey, Diane D; Fan, Fang; Husain, Mujtaba; Laser, Alice; Ocal, Idris T; Shen, Rulong Z; Goodrich, Kelly; Souers, Rhona J; Crothers, Barbara A

2016-12-01

- Since 2008, the College of American Pathologists has provided the human papillomavirus for cytology laboratories (CHPV) proficiency testing program to help laboratories meet the requirements of the Clinical Laboratory Improvement Amendments of 1988. - To provide an update on trends in proficiency testing performance in the College of American Pathologists CHPV program during the 4-year period from 2011 through 2014 and to compare those trends with the preceding first 3 years of the program. - Responses of laboratories participating in the CHPV program from 2011 through 2014 were analyzed using a nonlinear mixed model to compare different combinations of testing medium and platform. - In total, 818 laboratories participated in the CHPV program at least once during the 4 years, with participation increasing during the study period. Concordance of participant responses with the target result was more than 98% (38 280 of 38 892). Overall performance with all 3 testing media-ThinPrep (Hologic, Bedford, Massachusetts), SurePath (Becton, Dickinson and Company, Franklin Lakes, New Jersey), or Digene (Qiagen, Valencia, California)-was equivalent (P = .51), and all 4 US Food and Drug Administration (FDA)-approved platforms-Hybrid Capture 2 (Qiagen), Cervista (Hologic), Aptima (Hologic), and cobas (Roche Molecular Systems, Pleasanton, California)-outperformed laboratory-developed tests, unspecified commercial kits, and other (noncommercial) methods in ThinPrep medium (P < .001). However, certain off-label combinations of platform and medium, most notably Cervista with SurePath, demonstrated suboptimal performance (P < .001). - Laboratories demonstrated proficiency in using various combinations of testing media and platforms offered in the CHPV program, with statistically significant performance differences in certain combinations. These observations may be relevant in the current discussions about FDA oversight of laboratory-developed tests.

Viability testing of material derived from Mycobacterium tuberculosis prior to removal from a Containment Level-III Laboratory as part of a Laboratory Risk Assessment Program

PubMed Central

Blackwood, Kym S; Burdz, Tamara V; Turenne, Christine Y; Sharma, Meenu K; Kabani, Amin M; Wolfe, Joyce N

2005-01-01

Background In the field of clinical mycobacteriology, Mycobacterium tuberculosis (MTB) can be a difficult organism to manipulate due to the restrictive environment of a containment level 3 (CL3) laboratory. Tests for rapid diagnostic work involving smears and molecular methods do not require CL3 practices after the organism has been rendered non-viable. While it has been assumed that after organism deactivation these techniques can be performed outside of a CL3, no conclusive study has consistently confirmed that the organisms are noninfectious after the theoretical 'deactivation' steps. Previous studies have shown that initial steps (such as heating /chemical fixation) may not consistently kill MTB organisms. Methods An inclusive viability study (n = 226) was undertaken to determine at which point handling of culture extraction materials does not necessitate a CL3 environment. Four different laboratory protocols tested for viability included: standard DNA extractions for IS6110 fingerprinting, crude DNA preparations for PCR by boiling and mechanical lysis, protein extractions, and smear preparations. For each protocol, laboratory staff planted a proportion of the resulting material to Bactec 12B medium that was observed for growth for 8 weeks. Results Of the 208 isolates initially tested, 21 samples grew within the 8-week period. Sixteen (7.7%) of these yielded positive results for MTB that included samples of: deactivated culture resuspensions exposed to 80°C for 20 minutes, smear preparations and protein extractions. Test procedures were consequently modified and tested again (n = 18), resulting in 0% viability. Conclusions This study demonstrates that it cannot be assumed that conventional practices (i.e. smear preparation) or extraction techniques render the organism non-viable. All methodologies, new and existing, should be examined by individual laboratories to validate the safe removal of material derived from MTB to the outside of a CL3 laboratory. This process is vital to establish in house biosafety-validated practices with the aim of protecting laboratory workers conducting these procedures. PMID:15667662

Determination of insoluble, soluble, and total dietary fiber (CODEX definition) by enzymatic-gravimetric method and liquid chromatography: collaborative study.

PubMed

McCleary, Barry V; DeVries, Jonathan W; Rader, Jeanne I; Cohen, Gerald; Prosky, Leon; Mugford, David C; Okuma, Kazuhiro

2012-01-01

A method for the determination of insoluble (IDF), soluble (SDF), and total dietary fiber (TDF), as defined by the CODEX Alimentarius, was validated in foods. Based upon the principles of AOAC Official Methods 985.29, 991.43, 2001.03, and 2002.02, the method quantitates water-insoluble and water-soluble dietary fiber. This method extends the capabilities of the previously adopted AOAC Official Method 2009.01, Total Dietary Fiber in Foods, Enzymatic-Gravimetric-Liquid Chromatographic Method, applicable to plant material, foods, and food ingredients consistent with CODEX Definition 2009, including naturally occurring, isolated, modified, and synthetic polymers meeting that definition. The method was evaluated through an AOAC/AACC collaborative study. Twenty-two laboratories participated, with 19 laboratories returning valid assay data for 16 test portions (eight blind duplicates) consisting of samples with a range of traditional dietary fiber, resistant starch, and nondigestible oligosaccharides. The dietary fiber content of the eight test pairs ranged from 10.45 to 29.90%. Digestion of samples under the conditions of AOAC 2002.02 followed by the isolation, fractionation, and gravimetric procedures of AOAC 985.29 (and its extensions 991.42 and 993.19) and 991.43 results in quantitation of IDF and soluble dietary fiber that precipitates (SDFP). The filtrate from the quantitation of water-alcohol-insoluble dietary fiber is concentrated, deionized, concentrated again, and analyzed by LC to determine the SDF that remains soluble (SDFS), i.e., all dietary fiber polymers of degree of polymerization = 3 and higher, consisting primarily, but not exclusively, of oligosaccharides. SDF is calculated as the sum of SDFP and SDFS. TDF is calculated as the sum of IDF and SDF. The within-laboratory variability, repeatability SD (Sr), for IDF ranged from 0.13 to 0.71, and the between-laboratory variability, reproducibility SD (SR), for IDF ranged from 0.42 to 2.24. The within-laboratory variability Sr for SDF ranged from 0.28 to 1.03, and the between-laboratory variability SR for SDF ranged from 0.85 to 1.66. The within-laboratory variability Sr for TDF ranged from 0.47 to 1.41, and the between-laboratory variability SR for TDF ranged from 0.95 to 3.14. This is comparable to other official and approved dietary fiber methods, and the method is recommended for adoption as Official First Action.

Improving lab compaction specifications for flexible bases within the Texas DOT.

DOT National Transportation Integrated Search

2009-04-01

In Test Methods Tex-113-E and Tex-114-E, the Texas Department of Transportation (TxDOT) employs an impact hammer method of sample compaction for laboratory preparation of road base and subgrade materials for testing. In this third and final report do...

A transient laboratory method for determining the hydraulic properties of 'tight' rocks-I. Theory

USGS Publications Warehouse

Hsieh, P.A.; Tracy, J.V.; Neuzil, C.E.; Bredehoeft, J.D.; Silliman, Stephen E.

1981-01-01

Transient pulse testing has been employed increasingly in the laboratory to measure the hydraulic properties of rock samples with low permeability. Several investigators have proposed a mathematical model in terms of an initial-boundary value problem to describe fluid flow in a transient pulse test. However, the solution of this problem has not been available. In analyzing data from the transient pulse test, previous investigators have either employed analytical solutions that are derived with the use of additional, restrictive assumptions, or have resorted to numerical methods. In Part I of this paper, a general, analytical solution for the transient pulse test is presented. This solution is graphically illustrated by plots of dimensionless variables for several cases of interest. The solution is shown to contain, as limiting cases, the more restrictive analytical solutions that the previous investigators have derived. A method of computing both the permeability and specific storage of the test sample from experimental data will be presented in Part II. ?? 1981.

DNA-Based Methods in the Immunohematology Reference Laboratory

PubMed Central

Denomme, Gregory A

2010-01-01

Although hemagglutination serves the immunohematology reference laboratory well, when used alone, it has limited capability to resolve complex problems. This overview discusses how molecular approaches can be used in the immunohematology reference laboratory. In order to apply molecular approaches to immunohematology, knowledge of genes, DNA-based methods, and the molecular bases of blood groups are required. When applied correctly, DNA-based methods can predict blood groups to resolve ABO/Rh discrepancies, identify variant alleles, and screen donors for antigen-negative units. DNA-based testing in immunohematology is a valuable tool used to resolve blood group incompatibilities and to support patients in their transfusion needs. PMID:21257350

Topics on Test Methods for Space Systems and Operations Safety: Applicability of Experimental Data

NASA Technical Reports Server (NTRS)

Hirsch, David B.

2009-01-01

This viewgraph presentation reviews topics on test methods for space systems and operations safety through experimentation and analysis. The contents include: 1) Perception of reality through experimentation and analysis; 2) Measurements, methods, and correlations with real life; and 3) Correlating laboratory aerospace materials flammability data with data in spacecraft environments.

Laboratory Diagnosis of Tuberculosis in Resource-Poor Countries: Challenges and Opportunities

PubMed Central

Parsons, Linda M.; Somoskövi, Ákos; Gutierrez, Cristina; Lee, Evan; Paramasivan, C. N.; Abimiku, Alash'le; Spector, Steven; Roscigno, Giorgio; Nkengasong, John

2011-01-01

Summary: With an estimated 9.4 million new cases globally, tuberculosis (TB) continues to be a major public health concern. Eighty percent of all cases worldwide occur in 22 high-burden, mainly resource-poor settings. This devastating impact of tuberculosis on vulnerable populations is also driven by its deadly synergy with HIV. Therefore, building capacity and enhancing universal access to rapid and accurate laboratory diagnostics are necessary to control TB and HIV-TB coinfections in resource-limited countries. The present review describes several new and established methods as well as the issues and challenges associated with implementing quality tuberculosis laboratory services in such countries. Recently, the WHO has endorsed some of these novel methods, and they have been made available at discounted prices for procurement by the public health sector of high-burden countries. In addition, international and national laboratory partners and donors are currently evaluating other new diagnostics that will allow further and more rapid testing in point-of-care settings. While some techniques are simple, others have complex requirements, and therefore, it is important to carefully determine how to link these new tests and incorporate them within a country's national diagnostic algorithm. Finally, the successful implementation of these methods is dependent on key partnerships in the international laboratory community and ensuring that adequate quality assurance programs are inherent in each country's laboratory network. PMID:21482728

MODULAR ANALYTICS: A New Approach to Automation in the Clinical Laboratory.

PubMed

Horowitz, Gary L; Zaman, Zahur; Blanckaert, Norbert J C; Chan, Daniel W; Dubois, Jeffrey A; Golaz, Olivier; Mensi, Noury; Keller, Franz; Stolz, Herbert; Klingler, Karl; Marocchi, Alessandro; Prencipe, Lorenzo; McLawhon, Ronald W; Nilsen, Olaug L; Oellerich, Michael; Luthe, Hilmar; Orsonneau, Jean-Luc; Richeux, Gérard; Recio, Fernando; Roldan, Esther; Rymo, Lars; Wicktorsson, Anne-Charlotte; Welch, Shirley L; Wieland, Heinrich; Grawitz, Andrea Busse; Mitsumaki, Hiroshi; McGovern, Margaret; Ng, Katherine; Stockmann, Wolfgang

2005-01-01

MODULAR ANALYTICS (Roche Diagnostics) (MODULAR ANALYTICS, Elecsys and Cobas Integra are trademarks of a member of the Roche Group) represents a new approach to automation for the clinical chemistry laboratory. It consists of a control unit, a core unit with a bidirectional multitrack rack transportation system, and three distinct kinds of analytical modules: an ISE module, a P800 module (44 photometric tests, throughput of up to 800 tests/h), and a D2400 module (16 photometric tests, throughput up to 2400 tests/h). MODULAR ANALYTICS allows customised configurations for various laboratory workloads. The performance and practicability of MODULAR ANALYTICS were evaluated in an international multicentre study at 16 sites. Studies included precision, accuracy, analytical range, carry-over, and workflow assessment. More than 700 000 results were obtained during the course of the study. Median between-day CVs were typically less than 3% for clinical chemistries and less than 6% for homogeneous immunoassays. Median recoveries for nearly all standardised reference materials were within 5% of assigned values. Method comparisons versus current existing routine instrumentation were clinically acceptable in all cases. During the workflow studies, the work from three to four single workstations was transferred to MODULAR ANALYTICS, which offered over 100 possible methods, with reduction in sample splitting, handling errors, and turnaround time. Typical sample processing time on MODULAR ANALYTICS was less than 30 minutes, an improvement from the current laboratory systems. By combining multiple analytic units in flexible ways, MODULAR ANALYTICS met diverse laboratory needs and offered improvement in workflow over current laboratory situations. It increased overall efficiency while maintaining (or improving) quality.

MODULAR ANALYTICS: A New Approach to Automation in the Clinical Laboratory

PubMed Central

Zaman, Zahur; Blanckaert, Norbert J. C.; Chan, Daniel W.; Dubois, Jeffrey A.; Golaz, Olivier; Mensi, Noury; Keller, Franz; Stolz, Herbert; Klingler, Karl; Marocchi, Alessandro; Prencipe, Lorenzo; McLawhon, Ronald W.; Nilsen, Olaug L.; Oellerich, Michael; Luthe, Hilmar; Orsonneau, Jean-Luc; Richeux, Gérard; Recio, Fernando; Roldan, Esther; Rymo, Lars; Wicktorsson, Anne-Charlotte; Welch, Shirley L.; Wieland, Heinrich; Grawitz, Andrea Busse; Mitsumaki, Hiroshi; McGovern, Margaret; Ng, Katherine; Stockmann, Wolfgang

2005-01-01

MODULAR ANALYTICS (Roche Diagnostics) (MODULAR ANALYTICS, Elecsys and Cobas Integra are trademarks of a member of the Roche Group) represents a new approach to automation for the clinical chemistry laboratory. It consists of a control unit, a core unit with a bidirectional multitrack rack transportation system, and three distinct kinds of analytical modules: an ISE module, a P800 module (44 photometric tests, throughput of up to 800 tests/h), and a D2400 module (16 photometric tests, throughput up to 2400 tests/h). MODULAR ANALYTICS allows customised configurations for various laboratory workloads. The performance and practicability of MODULAR ANALYTICS were evaluated in an international multicentre study at 16 sites. Studies included precision, accuracy, analytical range, carry-over, and workflow assessment. More than 700 000 results were obtained during the course of the study. Median between-day CVs were typically less than 3% for clinical chemistries and less than 6% for homogeneous immunoassays. Median recoveries for nearly all standardised reference materials were within 5% of assigned values. Method comparisons versus current existing routine instrumentation were clinically acceptable in all cases. During the workflow studies, the work from three to four single workstations was transferred to MODULAR ANALYTICS, which offered over 100 possible methods, with reduction in sample splitting, handling errors, and turnaround time. Typical sample processing time on MODULAR ANALYTICS was less than 30 minutes, an improvement from the current laboratory systems. By combining multiple analytic units in flexible ways, MODULAR ANALYTICS met diverse laboratory needs and offered improvement in workflow over current laboratory situations. It increased overall efficiency while maintaining (or improving) quality. PMID:18924721

Use of proficiency samples to assess diagnostic laboratories in France performing a Trichinella digestion assay.

PubMed

Vallée, Isabelle; Macé, Pauline; Forbes, Lorry; Scandrett, Brad; Durand, Benoit; Gajadhar, Alvin; Boireau, Pascal

2007-07-01

Routine diagnosis of animal trichinellosis for food safety and trade relies on a method of artificial digestion to free Trichinella muscle larvae from meat for subsequent identification by microscopy. As part of a quality control system, the French National Reference Laboratory (NRL) initiated ring trials to determine the sensitivity of the test performed in the 72 routine diagnostic laboratories in France. A method was devised to obtain calibrated meat samples containing known numbers of capsules with Trichinella spiralis muscle larvae. This method was based on an incomplete artificial digestion of Trichinella-infected mice carcasses to allow the collection of intact Trichinella capsules. Capsules were placed into a meatball of 100 +/- 2 g of pork and horsemeat to produce proficiency samples. Three categories of samples were prepared: small (3 to 5 capsules), medium (7 to 10), and large (12 to 15). The sensitivity was expressed as the percentage of muscle larvae recovered from each proficiency sample. Reproducibility was tested with ring trials organized between two NRLs (France and Canada), and a reference sensitivity of 84.9% was established. National ring trials were then organized in France, with the 72 routine diagnostic laboratories each receiving four proficiency samples per session. After five sessions, an improvement in the digest test sensitivity was observed. Results at the fifth session indicated sensitivities of 78.60% +/- 23.70%, 81.19% +/- 19.59%, and 80.52% +/- 14.71% muscle larvae for small, medium, and large samples, respectively. This study supports the use of proficiency samples to accurately evaluate the performance of routine diagnostic laboratories that conduct digestion tests for animal trichinellosis diagnosis.

Measurement of Henry's Law Constants Using Internal Standards: A Quantitative GC Experiment for the Instrumental Analysis or Environmental Chemistry Laboratory

ERIC Educational Resources Information Center

Ji, Chang; Boisvert, Susanne M.; Arida, Ann-Marie C.; Day, Shannon E.

2008-01-01

An internal standard method applicable to undergraduate instrumental analysis or environmental chemistry laboratory has been designed and tested to determine the Henry's law constants for a series of alkyl nitriles. In this method, a mixture of the analytes and an internal standard is prepared and used to make a standard solution (organic solvent)…

A rapid method for soil cement design : Louisiana slope value method.

DOT National Transportation Integrated Search

1964-03-01

The current procedure used by the Louisiana Department of Highways for laboratory design of cement stabilized soil base and subbase courses is taken from standard AASHO test methods, patterned after Portland Cement Association criteria. These methods...

Review of the Agard S&M panel evaluation program of the NASA-Lewis 'SRP' approach to high-temperature LCF life prediction. [Strainrange Partitioning for Low Cycle Fatigue

NASA Technical Reports Server (NTRS)

Hirschberg, M. H.

1978-01-01

Twenty laboratories in six countries participated in this program, each testing its own materials of interest under its own laboratory conditions. In this way the results obtained provided validation of the Strainrange Partitioning (SRP) method for a wide range of materials and insured maximum usefulness to each of the participating laboratories. The first, very necessary step in the evaluation of any life prediction approach - assessing the ability of the method to predict life of simple laboratory specimens subjected to complex loading, was thereby taken. The culmination of this program was the Specialists Meeting that was held in Aalborg, Denmark in April of 1978. At that meeting the various investigators shared their findings, thus providing the basis for an in-depth evaluation of the SRP method. While the results were variable from laboratory to laboratory, most investigators agreed that the SRP method was a significant step toward life prediction in the presence of high temperature and cyclic stresses.

EVOKED POTENTIALS, PHYSIOLOGICAL METHODS WITH HUMAN APPLICATIONS

EPA Science Inventory

A number of tests and test batteries have been developed and implemented for detecting potential neurotoxicity in humans. n some cases test results may suggest specific dysfunction. hile tests in laboratory animals are often used to project the potential for adverse health effect...

Effects of laboratory heating, cyclic pore pressure, and cyclic loading on fracture properties of asphalt mixture.

DOT National Transportation Integrated Search

2012-04-01

This study involved the identification and evaluation of laboratory conditioning methods and testing protocols considering heat oxidation, moisture, and load that more effectively simulate asphalt mixture aging in the field, and thereby help to prope...

Theoretical Evaluation of the Transient Response of Constant Head and Constant Flow-Rate Permeability Tests

USGS Publications Warehouse

Zhang, M.; Takahashi, M.; Morin, R.H.; Esaki, T.

1998-01-01

A theoretical analysis is presented that compares the response characteristics of the constant head and the constant flowrate (flow pump) laboratory techniques for quantifying the hydraulic properties of geologic materials having permeabilities less than 10-10 m/s. Rigorous analytical solutions that describe the transient distributions of hydraulic gradient within a specimen are developed, and equations are derived for each method. Expressions simulating the inflow and outflow rates across the specimen boundaries during a constant-head permeability test are also presented. These solutions illustrate the advantages and disadvantages of each method, including insights into measurement accuracy and the validity of using Darcy's law under certain conditions. The resulting observations offer practical considerations in the selection of an appropriate laboratory test method for the reliable measurement of permeability in low-permeability geologic materials.

Use of Lean response to improve pandemic influenza surge in public health laboratories.

PubMed

Isaac-Renton, Judith L; Chang, Yin; Prystajecky, Natalie; Petric, Martin; Mak, Annie; Abbott, Brendan; Paris, Benjamin; Decker, K C; Pittenger, Lauren; Guercio, Steven; Stott, Jeff; Miller, Joseph D

2012-01-01

A novel influenza A (H1N1) virus detected in April 2009 rapidly spread around the world. North American provincial and state laboratories have well-defined roles and responsibilities, including providing accurate, timely test results for patients and information for regional public health and other decision makers. We used the multidisciplinary response and rapid implementation of process changes based on Lean methods at the provincial public health laboratory in British Columbia, Canada, to improve laboratory surge capacity in the 2009 influenza pandemic. Observed and computer simulating evaluation results from rapid processes changes showed that use of Lean tools successfully expanded surge capacity, which enabled response to the 10-fold increase in testing demands.

Underdiagnosis of Clostridium difficile across Europe: the European, multicentre, prospective, biannual, point-prevalence study of Clostridium difficile infection in hospitalised patients with diarrhoea (EUCLID).

PubMed

Davies, Kerrie A; Longshaw, Christopher M; Davis, Georgina L; Bouza, Emilio; Barbut, Frédéric; Barna, Zsuzsanna; Delmée, Michel; Fitzpatrick, Fidelma; Ivanova, Kate; Kuijper, Ed; Macovei, Ioana S; Mentula, Silja; Mastrantonio, Paola; von Müller, Lutz; Oleastro, Mónica; Petinaki, Efthymia; Pituch, Hanna; Norén, Torbjörn; Nováková, Elena; Nyč, Otakar; Rupnik, Maja; Schmid, Daniela; Wilcox, Mark H

2014-12-01

Variations in testing for Clostridium difficile infection can hinder patients' care, increase the risk of transmission, and skew epidemiological data. We aimed to measure the underdiagnosis of C difficile infection across Europe. We did a questionnaire-based study at 482 participating hospitals across 20 European countries. Hospitals were questioned about their methods and testing policy for C difficile infection during the periods September, 2011, to August, 2012, and September, 2012, to August, 2013. On one day in winter, 2012-13 (December, 2012, or January, 2013), and summer, 2013 (July or August), every hospital sent all diarrhoeal samples submitted to their microbiology laboratory to a national coordinating laboratory for standardised testing of C difficile infection. Our primary outcome measures were the rates of testing for and cases of C difficile infection per 10 000 patient bed-days. Results of local and national C difficile infection testing were compared with each other. If the result was positive at the national laboratory but negative at the local hospital, the result was classified as undiagnosed C difficile infection. We compared differences in proportions with the Mann-Whitney test, or McNemar's test if data were matched. During the study period, participating hospitals reported a mean of 65·8 tests (country range 4·6-223·3) for C difficile infection per 10 000 patient-bed days and a mean of 7·0 cases (country range 0·7-28·7) of C difficile infection per 10 000 patient-bed days. Only two-fifths of hospitals reported using optimum methods for testing of C difficile infection (defined by European guidelines), although the number of participating hospitals using optimum methods increased during the study period, from 152 (32%) of 468 in 2011-12 to 205 (48%) of 428 in 2012-13. Across all 482 European hospitals on the two sampling days, 148 (23%) of 641 samples positive for C difficile infection (as determined by the national laboratory) were not diagnosed by participating hospitals because of an absence of clinical suspicion, equating to about 74 missed diagnoses per day. A wide variety of testing strategies for C difficile infection are used across Europe. Absence of clinical suspicion and suboptimum laboratory diagnostic methods mean that an estimated 40 000 inpatients with C difficile infection are potentially undiagnosed every year in 482 European hospitals. Astellas Pharmaceuticals Europe. Copyright © 2014 Elsevier Ltd. All rights reserved.

Interactive laboratory classes enhance neurophysiological knowledge in Thai medical students.

PubMed

Wongjarupong, Nicha; Niyomnaitham, Danai; Vilaisaktipakorn, Pitchamol; Suksiriworaboot, Tanawin; Qureshi, Shaun Peter; Bongsebandhu-Phubhakdi, Saknan

2018-03-01

Interactive laboratory class (ILC) is a two-way communication teaching method that encourages students to correlate laboratory findings with materials from lectures. In Thai medical education, active learning methods are uncommon. This paper aims to establish 1) if ILCs would effectively promote physiology learning; 2) if effectiveness would be found in both previously academically high-performing and low-performing students; and 3) the acceptability of ILCs to Thai medical students as a novel learning method. Two hundred seventy-eight second-year medical students were recruited to this study. We conducted three ILC sessions, which followed corresponding lectures. We carried out multiple-choice pre- and post-ILC assessments of knowledge and compared by repeated-measures ANOVA and unpaired t-test. Subgroup analysis was performed to compare high-performance (HighP) and low-performance (LowP) students. After the ILCs, participants self-rated their knowledge and satisfaction. Post-ILC test scores increased significantly compared with pre-ILC test scores in all three sessions. Mean scores of each post-ILC test increased significantly from pre-ILC test in both LowP and HighP groups. More students self-reported a "very high" and "high" level of knowledge after ILCs. Most students agreed that ILCs provided more discussion opportunity, motivated their learning, and made lessons more enjoyable. As an adjunct to lectures, ILCs can enhance knowledge in medical students, regardless of previous academic performance. Students perceived ILC as useful and acceptable. This study supports the active learning methods in physiology education, regardless of cultural context.

Point-of-Care Hemoglobin A1c Testing: An Evidence-Based Analysis

PubMed Central

2014-01-01

Background The increasing prevalence of diabetes in Ontario means that there will be growing demand for hemoglobin A1c (HbA1c) testing to monitor glycemic control for the management of this chronic disease. Testing HbA1c where patients receive their diabetes care may improve system efficiency if the results from point-of-care HbA1c testing are comparable to those from laboratory HbA1c measurements. Objectives To review the correlation between point-of-care HbA1c testing and laboratory HbA1c measurement in patients with diabetes in clinical settings. Data Sources The literature search included studies published between January 2003 and June 2013. Search terms included glycohemoglobin, hemoglobin A1c, point of care, and diabetes. Review Methods Studies were included if participants had diabetes; if they compared point-of-care HbA1c devices (licensed by Health Canada and available in Canada) with laboratory HbA1c measurement (reference method); if they performed point-of-care HbA1c testing using capillary blood samples (finger pricks) and laboratory HbA1c measurement using venous blood samples within 7 days; and if they reported a correlation coefficient between point-of-care HbA1c and laboratory HbA1c results. Results Three point-of-care HbA1c devices were reviewed in this analysis: Bayer's A1cNow+, Bio-Rad's In2it, and Siemens’ DCA Vantage. Five observational studies met the inclusion criteria. The pooled results showed a positive correlation between point-of-care HbA1c testing and laboratory HbA1c measurement (correlation coefficient, 0.967; 95% confidence interval, 0.960–0.973). Limitations Outcomes were limited to the correlation coefficient, as this was a commonly reported measure of analytical performance in the literature. Results should be interpreted with caution due to risk of bias related to selection of participants, reference standards, and the multiple steps involved in POC HbA1c testing. Conclusions Moderate quality evidence showed a positive correlation between point-of-care HbA1c testing and laboratory HbA1c measurement. Five observational studies compared 3 point-of-care HbA1c devices with laboratory HbA1c assays, and all reported strong correlation between the 2 tests. PMID:26316922

Comparative Validation of Five Quantitative Rapid Test Kits for the Analysis of Salt Iodine Content: Laboratory Performance, User- and Field-Friendliness

PubMed Central

Rohner, Fabian; Kangambèga, Marcelline O.; Khan, Noor; Kargougou, Robert; Garnier, Denis; Sanou, Ibrahima; Ouaro, Bertine D.; Petry, Nicolai; Wirth, James P.; Jooste, Pieter

2015-01-01

Background Iodine deficiency has important health and development consequences and the introduction of iodized salt as national programs has been a great public health success in the past decades. To render national salt iodization programs sustainable and ensure adequate iodization levels, simple methods to quantitatively assess whether salt is adequately iodized are required. Several methods claim to be simple and reliable, and are available on the market or are in development. Objective This work has validated the currently available quantitative rapid test kits (quantRTK) in a comparative manner for both their laboratory performance and ease of use in field settings. Methods Laboratory performance parameters (linearity, detection and quantification limit, intra- and inter-assay imprecision) were conducted on 5 quantRTK. We assessed inter-operator imprecision using salt of different quality along with the comparison of 59 salt samples from across the globe; measurements were made both in a laboratory and a field setting by technicians and non-technicians. Results from the quantRTK were compared against iodometric titration for validity. An ‘ease-of-use’ rating system was developed to identify the most suitable quantRTK for a given task. Results Most of the devices showed acceptable laboratory performance, but for some of the devices, use by non-technicians revealed poorer performance when working in a routine manner. Of the quantRTK tested, the iCheck® and I-Reader® showed most consistent performance and ease of use, and a newly developed paper-based method (saltPAD) holds promise if further developed. Conclusions User- and field-friendly devices are now available and the most appropriate quantRTK can be selected depending on the number of samples and the budget available. PMID:26401655

Methods for microbiological and immunological studies of space flight crews

NASA Technical Reports Server (NTRS)

Taylor, G. R. (Editor); Zaloguev, S. N. (Editor)

1978-01-01

Systematic laboratory procedures compiled as an outgrowth of a joint U.S./U.S.S.R. microbiological-immunological experiment performed during the Apollo-Soyuz Test Project space flight are presented. Included are mutually compatible methods for the identification of aerobic and microaerophilic bacteria, yeast and yeastlike microorganisms, and filamentous fungi; methods for the bacteriophage typing of Staphylococcus aureus; and methods for determining the sensitivity of S. aureus to antibiotics. Immunological methods using blood and immunological and biochemical methods using salivary parotid fluid are also described. Formulas for media and laboratory reagents used are listed.

Cost evaluation of clinical laboratory in Taiwan's National Health System by using activity-based costing.

PubMed

Su, Bin-Guang; Chen, Shao-Fen; Yeh, Shu-Hsing; Shih, Po-Wen; Lin, Ching-Chiang

2016-11-01

To cope with the government's policies to reduce medical costs, Taiwan's healthcare service providers are striving to survive by pursuing profit maximization through cost control. This article aimed to present the results of cost evaluation using activity-based costing performed in the laboratory in order to throw light on the differences between costs and the payment system of National Health Insurance (NHI). This study analyzed the data of costs and income of the clinical laboratory. Direct costs belong to their respective sections of the department. The department's shared costs, including public expenses and administrative assigned costs, were allocated to the department's respective sections. A simple regression equation was created to predict profit and loss, and evaluate the department's break-even point, fixed cost, and contribution margin ratio. In clinical chemistry and seroimmunology sections, the cost per test was lower than the NHI payment and their major laboratory tests had revenues with the profitability ratio of 8.7%, while the other sections had a higher cost per test than the NHI payment and their major tests were in deficit. The study found a simple linear regression model as follows: "Balance=-84,995+0.543×income (R2=0.544)". In order to avoid deficit, laboratories are suggested to increase test volumes, enhance laboratory test specialization, and become marginal scale. A hospital could integrate with regional medical institutions through alliances or OEM methods to increase volumes to reach marginal scale and reduce laboratory costs, enhancing the level and quality of laboratory medicine.

40 CFR 258.41 - Project XL Bioreactor Landfill Projects.

Code of Federal Regulations, 2012 CFR

2012-07-01

... using the Standard Test Method for Measuring Mass per Unit Area of Geotextiles, ASTM D-5261-92... determined by the Standard Test Method for Laboratory Determination of Water (Moisture) Content of Soil and... with the provisions of the FESOP, during the entire period of leachate recirculation and the post...

40 CFR 258.41 - Project XL Bioreactor Landfill Projects.

Code of Federal Regulations, 2011 CFR

2011-07-01

... using the Standard Test Method for Measuring Mass per Unit Area of Geotextiles, ASTM D-5261-92... determined by the Standard Test Method for Laboratory Determination of Water (Moisture) Content of Soil and... with the provisions of the FESOP, during the entire period of leachate recirculation and the post...

40 CFR 258.41 - Project XL Bioreactor Landfill Projects.

Code of Federal Regulations, 2013 CFR

2013-07-01

... using the Standard Test Method for Measuring Mass per Unit Area of Geotextiles, ASTM D-5261-92... determined by the Standard Test Method for Laboratory Determination of Water (Moisture) Content of Soil and... with the provisions of the FESOP, during the entire period of leachate recirculation and the post...

Performance Tested Method multiple laboratory validation study of ELISA-based assays for the detection of peanuts in food.

PubMed

Park, Douglas L; Coates, Scott; Brewer, Vickery A; Garber, Eric A E; Abouzied, Mohamed; Johnson, Kurt; Ritter, Bruce; McKenzie, Deborah

2005-01-01

Performance Tested Method multiple laboratory validations for the detection of peanut protein in 4 different food matrixes were conducted under the auspices of the AOAC Research Institute. In this blind study, 3 commercially available ELISA test kits were validated: Neogen Veratox for Peanut, R-Biopharm RIDASCREEN FAST Peanut, and Tepnel BioKits for Peanut Assay. The food matrixes used were breakfast cereal, cookies, ice cream, and milk chocolate spiked at 0 and 5 ppm peanut. Analyses of the samples were conducted by laboratories representing industry and international and U.S governmental agencies. All 3 commercial test kits successfully identified spiked and peanut-free samples. The validation study required 60 analyses on test samples at the target level 5 microg peanut/g food and 60 analyses at a peanut-free level, which was designed to ensure that the lower 95% confidence limit for the sensitivity and specificity would not be <90%. The probability that a test sample contains an allergen given a prevalence rate of 5% and a positive test result using a single test kit analysis with 95% sensitivity and 95% specificity, which was demonstrated for these test kits, would be 50%. When 2 test kits are run simultaneously on all samples, the probability becomes 95%. It is therefore recommended that all field samples be analyzed with at least 2 of the validated kits.

Diagnostic tests in HIV management: a review of clinical and laboratory strategies to monitor HIV-infected individuals in developing countries.

PubMed Central

Kimmel, April D.; Losina, Elena; Freedberg, Kenneth A.; Goldie, Sue J.

2006-01-01

We conducted a systematic review on the performance of diagnostic tests for clinical and laboratory monitoring of HIV-infected adults in developing countries. Diagnostic test information collected from computerized databases, bibliographies and the Internet were categorized as clinical (non-laboratory patient information), immunologic (information from immunologic laboratory tests), or virologic (information from virologic laboratory tests). Of the 51 studies selected for the review 28 assessed immunologic tests, 12 virologic tests and seven clinical and immunologic tests. Methods of performance evaluation were primarily sensitivity and specificity for the clinical category and correlation coefficients for immunologic and virologic categories. In the clinical category, the majority of test performance measures was reported as >70% sensitive and >65% specific. In the immunologic category, correlation coefficients ranged from r=0.54 to r=0.99 for different CD4 count enumeration techniques, while correlation for CD4 and total lymphocyte counts was between r=0.23 and r=0.74. In the virologic category, correlation coefficients for different human immunodeficiency virus (HIV) ribonucleic acid (RNA) quantification techniques ranged from r=0.54 to r=0.90. Future research requires consensus on designing studies, and collecting and reporting data useful for decision-makers. We recommend classifying information into clinically relevant categories, using a consistent definition of disease across studies and providing measures of both association and accuracy. PMID:16878233

Reproducibility of risk figures in 2nd-trimester maternal serum screening for down syndrome: comparison of 2 laboratories.

PubMed

Benn, Peter A; Makowski, Gregory S; Egan, James F X; Wright, Dave

2006-11-01

Analytical error affects 2nd-trimester maternal serum screening for Down syndrome risk estimation. We analyzed the between-laboratory reproducibility of risk estimates from 2 laboratories. Laboratory 1 used Bayer ACS180 immunoassays for alpha-fetoprotein (AFP) and human chorionic gonadotropin (hCG), Diagnostic Systems Laboratories (DSL) RIA for unconjugated estriol (uE3), and DSL enzyme immunoassay for inhibin-A (INH-A). Laboratory 2 used Beckman immunoassays for AFP, hCG, and uE3, and DSL enzyme immunoassay for INH-A. Analyte medians were separately established for each laboratory. We used the same computational algorithm for all risk calculations, and we used Monte Carlo methods for computer modeling. For 462 samples tested, risk figures from the 2 laboratories differed >2-fold for 44.7%, >5-fold for 7.1%, and >10-fold for 1.7%. Between-laboratory differences in analytes were greatest for uE3 and INH-A. The screen-positive rates were 9.3% for laboratory 1 and 11.5% for laboratory 2, with a significant difference in the patients identified as screen-positive vs screen-negative (McNemar test, P<0.001). Computer modeling confirmed the large between-laboratory risk differences. Differences in performance of assays and laboratory procedures can have a large effect on patient-specific risks. Screening laboratories should minimize test imprecision and ensure that each assay performs in a manner similar to that assumed in the risk computational algorithm.

Comparison of a New Cobinamide-Based Method to a Standard Laboratory Method for Measuring Cyanide in Human Blood

PubMed Central

Swezey, Robert; Shinn, Walter; Green, Carol; Drover, David R.; Hammer, Gregory B.; Schulman, Scott R.; Zajicek, Anne; Jett, David A.; Boss, Gerry R.

2013-01-01

Most hospital laboratories do not measure blood cyanide concentrations, and samples must be sent to reference laboratories. A simple method is needed for measuring cyanide in hospitals. The authors previously developed a method to quantify cyanide based on the high binding affinity of the vitamin B12 analog, cobinamide, for cyanide and a major spectral change observed for cyanide-bound cobinamide. This method is now validated in human blood, and the findings include a mean inter-assay accuracy of 99.1%, precision of 8.75% and a lower limit of quantification of 3.27 µM cyanide. The method was applied to blood samples from children treated with sodium nitroprusside and it yielded measurable results in 88 of 172 samples (51%), whereas the reference laboratory yielded results in only 19 samples (11%). In all 19 samples, the cobinamide-based method also yielded measurable results. The two methods showed reasonable agreement when analyzed by linear regression, but not when analyzed by a standard error of the estimate or paired t-test. Differences in results between the two methods may be because samples were assayed at different times on different sample types. The cobinamide-based method is applicable to human blood, and can be used in hospital laboratories and emergency rooms. PMID:23653045

Validation of the OECD reproduction test guideline with the New Zealand mudsnail Potamopyrgus antipodarum using trenbolone and prochloraz.

PubMed

Geiß, Cornelia; Ruppert, Katharina; Askem, Clare; Barroso, Carlos; Faber, Daniel; Ducrot, Virginie; Holbech, Henrik; Hutchinson, Thomas H; Kajankari, Paula; Kinnberg, Karin Lund; Lagadic, Laurent; Matthiessen, Peter; Morris, Steve; Neiman, Maurine; Penttinen, Olli-Pekka; Sanchez-Marin, Paula; Teigeler, Matthias; Weltje, Lennart; Oehlmann, Jörg

2017-04-01

The Organisation for Economic Cooperation and Development (OECD) provides several standard test methods for the environmental hazard assessment of chemicals, mainly based on primary producers, arthropods, and fish. In April 2016, two new test guidelines with two mollusc species representing different reproductive strategies were approved by OECD member countries. One test guideline describes a 28-day reproduction test with the parthenogenetic New Zealand mudsnail Potamopyrgus antipodarum. The main endpoint of the test is reproduction, reflected by the embryo number in the brood pouch per female. The development of a new OECD test guideline involves several phases including inter-laboratory validation studies to demonstrate the robustness of the proposed test design and the reproducibility of the test results. Therefore, a ring test of the reproduction test with P. antipodarum was conducted including eight laboratories with the test substances trenbolone and prochloraz and results are presented here. Most laboratories could meet test validity criteria, thus demonstrating the robustness of the proposed test protocol. Trenbolone did not have an effect on the reproduction of the snails at the tested concentration range (nominal: 10-1000 ng/L). For prochloraz, laboratories produced similar EC 10 and NOEC values, showing the inter-laboratory reproducibility of results. The average EC 10 and NOEC values for reproduction (with coefficient of variation) were 26.2 µg/L (61.7%) and 29.7 µg/L (32.9%), respectively. This ring test shows that the mudsnail reproduction test is a well-suited tool for use in the chronic aquatic hazard and risk assessment of chemicals.

Utility of NIST Whole-Genome Reference Materials for the Technical Validation of a Multigene Next-Generation Sequencing Test.

PubMed

Shum, Bennett O V; Henner, Ilya; Belluoccio, Daniele; Hinchcliffe, Marcus J

2017-07-01

The sensitivity and specificity of next-generation sequencing laboratory developed tests (LDTs) are typically determined by an analyte-specific approach. Analyte-specific validations use disease-specific controls to assess an LDT's ability to detect known pathogenic variants. Alternatively, a methods-based approach can be used for LDT technical validations. Methods-focused validations do not use disease-specific controls but use benchmark reference DNA that contains known variants (benign, variants of unknown significance, and pathogenic) to assess variant calling accuracy of a next-generation sequencing workflow. Recently, four whole-genome reference materials (RMs) from the National Institute of Standards and Technology (NIST) were released to standardize methods-based validations of next-generation sequencing panels across laboratories. We provide a practical method for using NIST RMs to validate multigene panels. We analyzed the utility of RMs in validating a novel newborn screening test that targets 70 genes, called NEO1. Despite the NIST RM variant truth set originating from multiple sequencing platforms, replicates, and library types, we discovered a 5.2% false-negative variant detection rate in the RM truth set genes that were assessed in our validation. We developed a strategy using complementary non-RM controls to demonstrate 99.6% sensitivity of the NEO1 test in detecting variants. Our findings have implications for laboratories or proficiency testing organizations using whole-genome NIST RMs for testing. Copyright © 2017 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

Harmonization in laboratory medicine: Requests, samples, measurements and reports.

PubMed

Plebani, Mario

2016-01-01

In laboratory medicine, the terms "standardization" and "harmonization" are frequently used interchangeably as the final goal is the same: the equivalence of measurement results among different routine measurement procedures over time and space according to defined analytical and clinical quality specifications. However, the terms define two distinct, albeit closely linked, concepts based on traceability principles. The word "standardization" is used when results for a measurement are equivalent and traceable to the International System of Units (SI) through a high-order primary reference material and/or a reference measurement procedure (RMP). "Harmonization" is generally used when results are equivalent, but neither a high-order primary reference material nor a reference measurement procedure is available. Harmonization is a fundamental aspect of quality in laboratory medicine as its ultimate goal is to improve patient outcomes through the provision of accurate and actionable laboratory information. Patients, clinicians and other healthcare professionals assume that clinical laboratory tests performed by different laboratories at different times on the same sample and specimen can be compared, and that results can be reliably and consistently interpreted. Unfortunately, this is not necessarily the case, because many laboratory test results are still highly variable and poorly standardized and harmonized. Although the initial focus was mainly on harmonizing and standardizing analytical processes and methods, the scope of harmonization now also includes all other aspects of the total testing process (TTP), such as terminology and units, report formats, reference intervals and decision limits as well as tests and test profiles, requests and criteria for interpretation. Several projects and initiatives aiming to improve standardization and harmonization in the testing process are now underway. Laboratory professionals should therefore step up their efforts to provide interchangeable and comparable laboratory information in order to ultimately assure better diagnosis and treatment in patient care.

Evaluation of FEM engineering parameters from insitu tests

DOT National Transportation Integrated Search

2001-12-01

The study looked critically at insitu test methods (SPT, CPT, DMT, and PMT) as a means for developing finite element constitutive model input parameters. The first phase of the study examined insitu test derived parameters with laboratory triaxial te...

Alkali content of fly ash : measuring and testing strategies for compliance : [tech transfer summary].

DOT National Transportation Integrated Search

2015-04-01

This study investigated the test methods used to determine the : alkali content of fly ash. It also evaluated if high-alkali fly ash : exacerbates alkali-silica reaction in laboratory tests and field : concrete.

Microfermentation Test For Identification Of Yeast

NASA Technical Reports Server (NTRS)

Pierson, D. L.; Mishra, S. K.; Molina, Thomas C.

1995-01-01

Microfermentation test developed as supplementary method for use in identifying yeasts, especially in clinical and environmental studies. In comparison with traditional fermentation tests, simpler and easier, and requiries less equipment, material, and laboratory space. Results obtained in days instead of weeks.

[Establishment of Quality Control System of Nucleic Acid Detection for Ebola Virus in Sierra Leone-China Friendship Biological Safety Laboratory].

PubMed

Wang, Qin; Zhang, Yong; Nie, Kai; Wang, Huanyu; Du, Haijun; Song, Jingdong; Xiao, Kang; Lei, Wenwen; Guo, Jianqiang; Wei, Hejiang; Cai, Kun; Wang, Yanhai; Wu, Jiang; Gerald, Bangura; Kamara, Idrissa Laybohr; Liang, Mifang; Wu, Guizhen; Dong, Xiaoping

2016-03-01

The quality control process throughout the Ebola virus nucleic acid detection in Sierra Leone-China Friendship Biological Safety Laboratory (SLE-CHN Biosafety Lab) was described in detail, in order to comprehensively display the scientific, rigorous, accurate and efficient practice in detection of Ebola virus of first batch detection team in SLE-CHN Biosafety Lab. Firstly, the key points of laboratory quality control system was described, including the managements and organizing, quality control documents and information management, instrument, reagents and supplies, assessment, facilities design and space allocation, laboratory maintenance and biosecurity. Secondly, the application of quality control methods in the whole process of the Ebola virus detection, including before the test, during the test and after the test, was analyzed. The excellent and professional laboratory staffs, the implementation of humanized management are the cornerstone of the success; High-level biological safety protection is the premise for effective quality control and completion of Ebola virus detection tasks. And professional logistics is prerequisite for launching the laboratory diagnosis of Ebola virus. The establishment and running of SLE-CHN Biosafety Lab has landmark significance for the friendship between Sierra Leone and China, and the lab becomes the most important base for Ebola virus laboratory testing in Sierra Leone.

Prioritizing CD4 Count Monitoring in Response to ART in Resource-Constrained Settings: A Retrospective Application of Prediction-Based Classification

PubMed Central

Liu, Yan; Li, Xiaohong; Johnson, Margaret; Smith, Collette; Kamarulzaman, Adeeba bte; Montaner, Julio; Mounzer, Karam; Saag, Michael; Cahn, Pedro; Cesar, Carina; Krolewiecki, Alejandro; Sanne, Ian; Montaner, Luis J.

2012-01-01

Background Global programs of anti-HIV treatment depend on sustained laboratory capacity to assess treatment initiation thresholds and treatment response over time. Currently, there is no valid alternative to CD4 count testing for monitoring immunologic responses to treatment, but laboratory cost and capacity limit access to CD4 testing in resource-constrained settings. Thus, methods to prioritize patients for CD4 count testing could improve treatment monitoring by optimizing resource allocation. Methods and Findings Using a prospective cohort of HIV-infected patients (n = 1,956) monitored upon antiretroviral therapy initiation in seven clinical sites with distinct geographical and socio-economic settings, we retrospectively apply a novel prediction-based classification (PBC) modeling method. The model uses repeatedly measured biomarkers (white blood cell count and lymphocyte percent) to predict CD4+ T cell outcome through first-stage modeling and subsequent classification based on clinically relevant thresholds (CD4+ T cell count of 200 or 350 cells/µl). The algorithm correctly classified 90% (cross-validation estimate = 91.5%, standard deviation [SD] = 4.5%) of CD4 count measurements <200 cells/µl in the first year of follow-up; if laboratory testing is applied only to patients predicted to be below the 200-cells/µl threshold, we estimate a potential savings of 54.3% (SD = 4.2%) in CD4 testing capacity. A capacity savings of 34% (SD = 3.9%) is predicted using a CD4 threshold of 350 cells/µl. Similar results were obtained over the 3 y of follow-up available (n = 619). Limitations include a need for future economic healthcare outcome analysis, a need for assessment of extensibility beyond the 3-y observation time, and the need to assign a false positive threshold. Conclusions Our results support the use of PBC modeling as a triage point at the laboratory, lessening the need for laboratory-based CD4+ T cell count testing; implementation of this tool could help optimize the use of laboratory resources, directing CD4 testing towards higher-risk patients. However, further prospective studies and economic analyses are needed to demonstrate that the PBC model can be effectively applied in clinical settings. Please see later in the article for the Editors' Summary PMID:22529752

Analytical control test plan and microbiological methods for the water recovery test

NASA Technical Reports Server (NTRS)

Traweek, M. S. (Editor); Tatara, J. D. (Editor)

1994-01-01

Qualitative and quantitative laboratory results are important to the decision-making process. In some cases, they may represent the only basis for deciding between two or more given options or processes. Therefore, it is essential that handling of laboratory samples and analytical operations employed are performed at a deliberate level of conscientious effort. Reporting erroneous results can lead to faulty interpretations and result in misinformed decisions. This document provides analytical control specifications which will govern future test procedures related to all Water Recovery Test (WRT) Phase 3 activities to be conducted at the National Aeronautics and Space Administration/Marshall Space Flight Center (NASA/MSFC). This document addresses the process which will be used to verify analytical data generated throughout the test period, and to identify responsibilities of key personnel and participating laboratories, the chains of communication to be followed, and ensure that approved methodology and procedures are used during WRT activities. This document does not outline specifics, but provides a minimum guideline by which sampling protocols, analysis methodologies, test site operations, and laboratory operations should be developed.

Building America Top Innovations 2014 Profile: HVAC Cabinet Air Leakage Test Method

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

none,

This 2014 Top Innovation profile describes Building America-funded research by teams and national laboratories that resulted in the development of an ASHRAE standard and a standardized testing method for testing the air leakage of HVAC air handlers and furnace cabinets and has spurred equipment manufacturers to tighten the cabinets they use for residential HVAC systems.

Levofloxacin susceptibility testing against Helicobacter pylori: evaluation of a modified disk diffusion method compared to E test.

PubMed

Boyanova, Lyudmila; Ilieva, Juliana; Gergova, Galina; Mitov, Ivan

2016-01-01

We compared levofloxacin (1 μg/disk) disk diffusion method to E test against 212 Helicobacter pylori strains. Using diameter breakpoints for susceptibility (≥15 mm) and resistance (≤9 mm), very major error, major error rate, and categoric agreement were 0.0%, 0.6%, and 93.9%, respectively. The method may be useful in low-resource laboratories. Copyright © 2016 Elsevier Inc. All rights reserved.

Use of the laboratory tests of soil modulus in modelling pile behaviour

NASA Astrophysics Data System (ADS)

Dyka, Ireneusz

2012-10-01

This article deals with the question of theoretical description of behaviour of a single pile rested in a layered soil medium. Particular attention is paid to soil modulus which is used in calculation method for pile load-settlement curve. A brief analysis of the results obtained by laboratory tests to assess soil modulus and its nonlinear variability has been presented. The results of tests have been used in triaxial apparatus and resonant column/torsional shear device. There have also been presented the results of load-settlement calculation for a single pile under axial load with implementation of different models of soil modulus degradation. On this basis, possibilities of using particular kinds of laboratory tests in calculation procedure of foundation settlement have been presented as well as further developments of them.

Laboratory Analytical Procedures | Bioenergy | NREL

Science.gov Websites

analytical procedures (LAPs) to provide validated methods for biofuels and pyrolysis bio-oils research . Biomass Compositional Analysis These lab procedures provide tested and accepted methods for performing

First round of external quality assessment of dengue diagnostics in the WHO Western Pacific Region, 2013.

PubMed

Pok, Kwoon Yong; Squires, Raynal C; Tan, Li Kiang; Takasaki, Tomohiko; Abubakar, Sazaly; Hasebe, Futoshi; Partridge, Jeffrey; Lee, Chin Kei; Lo, Janice; Aaskov, John; Ng, Lee Ching; Konings, Frank

2015-01-01

Accurate laboratory testing is a critical component of dengue surveillance and control. The objective of this programme was to assess dengue diagnostic proficiency among national-level public health laboratories in the World Health Organization (WHO) Western Pacific Region. Nineteen national-level public health laboratories performed routine dengue diagnostic assays on a proficiency testing panel consisting of two modules: one containing commercial serum samples spiked with cultured dengue viruses for the detection of nucleic acid and non-structural protein 1 (NS1) (Module A) and one containing human serum samples for the detection of anti-dengue virus antibodies (Module B). A review of logistics arrangements was also conducted. All 16 laboratories testing Module A performed reverse transcriptase polymerase chain reaction (RT-PCR) for both RNA and serotype detection. Of these, 15 had correct results for RNA detection and all 16 correctly serotyped the viruses. All nine laboratories performing NS1 antigen detection obtained the correct results. Sixteen of the 18 laboratories using IgM assays in Module B obtained the correct results as did the 13 laboratories that performed IgG assays. Detection of ongoing/recent dengue virus infection by both molecular (RT-PCR) and serological methods (IgM) was available in 15/19 participating laboratories. This first round of external quality assessment of dengue diagnostics was successfully conducted in national-level public health laboratories in the WHO Western Pacific Region, revealing good proficiency in both molecular and serological testing. Further comprehensive diagnostic testing for dengue virus and other priority pathogens in the Region will be assessed during future rounds.

Woodstove smoke and CO emissions: comparison of reference methods with the VIP sampler.

PubMed

Jaasma, D R; Champion, M C; Shelton, J W

1990-06-01

A new field sampler has been developed for measuring the particulate matter (PM) and carbon monoxide emissions of woodburning stoves. Particulate matter is determined by carbon balance and the workup of a sample train which is similar to a room-temperature EPA Method 5G train. A steel tank, initially evacuated, serves as the motive force for sampling and also accumulates a gas sample for post-test analysis of time-averaged stack CO and CO2 concentrations. Workup procedures can be completed within 72 hours of sampler retrieval. The system has been compared to reference methods in two laboratory test series involving six different woodburning appliances and two independent laboratories. The correlation of field sampler emission rates and reference method rates is strong.

Woodstove smoke and CO emissions: Comparison of reference methods with the VIP sampler

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

Jaasma, D.R.; Champion, M.C.; Shelton, J.W.

1990-06-01

A new field sampler has been developed for measuring the particulate matter (PM) and carbon monoxide emissions of woodburning stoves. Particulate matter is determined by carbon balance and the workup of a sample train which is similar to a room-temperature EPA Method 5G train. A steel tank, initially evacuated, serves as the motive force for sampling and also accumulates a gas sample for post-test analysis of time-averaged stack CO and CO{sub 2} concentrations. Workup procedures can be completed within 72 hours of sampler retrieval. The system has been compared to reference methods in two laboratory test series involving six differentmore » woodburning appliances and two independent laboratories. The correlation of field sampler emission rates and reference method rates is strong.« less

The Significance of A Neglected Romanian Book - "The Methods of the Clinical Laboratory", by Ioan Manta and Alexandru Ciplea.

PubMed

Barsu, Cristian

2017-04-06

"The Methods of Clinical Laboratory" was the first comprehensive Romanian book in the medical laboratory field, having utility in clinical practice. It was written by Prof. Ioan Manta (1900-1979) and Alexandru Ciplea (1912-1988), both from the Cluj Faculty of Medicine. The volume was published for the first time in 1944, during the refuge of this Faculty in Sibiu, and for the second time in 1947, in Cluj. Our aim is to make a brief analysis of its structure and to put into evidence the importance of this book for the Romanian laboratory medicine, some techniques (e.g. microscopic techniques) keeping their validity until today. The authors made over 800 detailed presentations about: laboratory sampling and preservation techniques, different types of tests and methods for qualitative and quantitative determinations, techniques to prepare various solutions, microbiological culture media, laboratory stains and reagents, as well as maneuvering of some laboratory equipments. For each method, Manta and Ciplea presented: the principle of working method, reagents required, the working technique, mode of calculation, the result and its interpretation. It also includes some laboratory apparatus descriptions, as well as their mode of working. With regard to the scientific value and to the practical utility of this book, it remains a very important milestone in the Romanian medical literature of the XX-th century.

Antimicrobial Susceptibility Testing, Drug Resistance Mechanisms, and Therapy of Infections with Nontuberculous Mycobacteria

PubMed Central

Nash, Kevin A.; Wallace, Richard J.

2012-01-01

Summary: Within the past 10 years, treatment and diagnostic guidelines for nontuberculous mycobacteria have been recommended by the American Thoracic Society (ATS) and the Infectious Diseases Society of America (IDSA). Moreover, the Clinical and Laboratory Standards Institute (CLSI) has published and recently (in 2011) updated recommendations including suggested antimicrobial and susceptibility breakpoints. The CLSI has also recommended the broth microdilution method as the gold standard for laboratories performing antimicrobial susceptibility testing of nontuberculous mycobacteria. This article reviews the laboratory, diagnostic, and treatment guidelines together with established and probable drug resistance mechanisms of the nontuberculous mycobacteria. PMID:22763637

FEASIBILITY OF HYDRAULIC FRACTURING OF SOILS TO IMPROVE REMEDIAL ACTIONS

EPA Science Inventory

Hydraulic fracturing, a technique commonly used to increase the yields of oil wells, could improve the effectiveness of several methods of in situ remediation. This project consisted of laboratory and field tests in which hydraulic fractures were created in soil. Laboratory te...

Computer Series, 61: Bits & Pieces, 24.

ERIC Educational Resources Information Center

Moore, John W., Ed.

1985-01-01

Describes: (1) laboratory information science in the clinical chemistry curriculum; (2) testing Boyle's Law, a context for statistical methods in undergraduate laboratories; (3) acquiring chemical concepts using microcomputers as tutees; and (4) using Data Interchange Format files for Apple microcomputers. Includes feedback from a previous article…

National survey on intra-laboratory turnaround time for some most common routine and stat laboratory analyses in 479 laboratories in China

PubMed Central

Fei, Yang; Zeng, Rong; Wang, Wei; He, Falin; Zhong, Kun

2015-01-01

Introduction To investigate the state of the art of intra-laboratory turnaround time (intra-TAT), provide suggestions and find out whether laboratories accredited by International Organization for Standardization (ISO) 15189 or College of American Pathologists (CAP) will show better performance on intra-TAT than non-accredited ones. Materials and methods 479 Chinese clinical laboratories participating in the external quality assessment programs of chemistry, blood gas, and haematology tests organized by the National Centre for Clinical Laboratories in China were included in our study. General information and the median of intra-TAT of routine and stat tests in last one week were asked in the questionnaires. Results The response rate of clinical biochemistry, blood gas, and haematology testing were 36% (479 / 1307), 38% (228 / 598), and 36% (449 / 1250), respectively. More than 50% of laboratories indicated that they had set up intra-TAT median goals and almost 60% of laboratories declared they had monitored intra-TAT generally for every analyte they performed. Among all analytes we investigated, the intra-TAT of haematology analytes was shorter than biochemistry while the intra-TAT of blood gas analytes was the shortest. There were significant differences between median intra-TAT on different days of the week for routine tests. However, there were no significant differences in median intra-TAT reported by accredited laboratories and non-accredited laboratories. Conclusions Many laboratories in China are aware of intra-TAT control and are making effort to reach the target. There is still space for improvement. Accredited laboratories have better status on intra-TAT monitoring and target setting than the non-accredited, but there are no significant differences in median intra-TAT reported by them. PMID:26110033

Enhancement of hepatitis virus immunoassay outcome predictions in imbalanced routine pathology data by data balancing and feature selection before the application of support vector machines.

PubMed

Richardson, Alice M; Lidbury, Brett A

2017-08-14

Data mining techniques such as support vector machines (SVMs) have been successfully used to predict outcomes for complex problems, including for human health. Much health data is imbalanced, with many more controls than positive cases. The impact of three balancing methods and one feature selection method is explored, to assess the ability of SVMs to classify imbalanced diagnostic pathology data associated with the laboratory diagnosis of hepatitis B (HBV) and hepatitis C (HCV) infections. Random forests (RFs) for predictor variable selection, and data reshaping to overcome a large imbalance of negative to positive test results in relation to HBV and HCV immunoassay results, are examined. The methodology is illustrated using data from ACT Pathology (Canberra, Australia), consisting of laboratory test records from 18,625 individuals who underwent hepatitis virus testing over the decade from 1997 to 2007. Overall, the prediction of HCV test results by immunoassay was more accurate than for HBV immunoassay results associated with identical routine pathology predictor variable data. HBV and HCV negative results were vastly in excess of positive results, so three approaches to handling the negative/positive data imbalance were compared. Generating datasets by the Synthetic Minority Oversampling Technique (SMOTE) resulted in significantly more accurate prediction than single downsizing or multiple downsizing (MDS) of the dataset. For downsized data sets, applying a RF for predictor variable selection had a small effect on the performance, which varied depending on the virus. For SMOTE, a RF had a negative effect on performance. An analysis of variance of the performance across settings supports these findings. Finally, age and assay results for alanine aminotransferase (ALT), sodium for HBV and urea for HCV were found to have a significant impact upon laboratory diagnosis of HBV or HCV infection using an optimised SVM model. Laboratories looking to include machine learning via SVM as part of their decision support need to be aware that the balancing method, predictor variable selection and the virus type interact to affect the laboratory diagnosis of hepatitis virus infection with routine pathology laboratory variables in different ways depending on which combination is being studied. This awareness should lead to careful use of existing machine learning methods, thus improving the quality of laboratory diagnosis.

Clinical utility of routine laboratory testing to identify possible secondary causes in older men with osteoporosis: the Osteoporotic Fractures in Men (MrOS) Study

PubMed Central

Fink, Howard A.; Litwack-Harrison, Stephanie; Taylor, Brent C.; Bauer, Douglas C.; Orwoll, Eric S.; Lee, Christine G.; Barrett-Connor, Elizabeth; Schousboe, John T.; Kado, Deborah M.; Garimella, Pranav S.; Ensrud, Kristine E.

2016-01-01

Purpose To evaluate the utility of recommended laboratory testing to identify secondary causes in older men with osteoporosis, we examined prevalence of laboratory abnormalities in older men with and without osteoporosis. Methods 1572 men aged ≥65 years in the Osteoporotic Fractures in Men study completed bone mineral density (BMD) testing and a battery of laboratory measures, including serum calcium, phosphorus, alkaline phosphatase, parathyroid hormone (PTH), thyroid-stimulating hormone (TSH), 25-OH vitamin D, total testosterone, spot urine calcium/creatinine ratio, spot urine albumin-creatinine ratio, creatinine-derived estimate glomerular filtration rate, 24-hour urine calcium, and 24-hour urine free cortisol. Using cross-sectional analyses, we calculated prevalence ratios (PR) and 95% confidence intervals (CI) for the association of any and specific laboratory abnormalities with osteoporosis, and the number of men with osteoporosis needed to test to identify one additional laboratory abnormality compared to testing men without osteoporosis. Results Approximately 60% of men had ≥1 laboratory abnormality in both men with and without osteoporosis. Among individual tests, only vitamin D insufficiency (PR, 1.13; 95% CI, 1.05–1.22) and high alkaline phosphatase (PR, 3.05; 95% CI, 1.52–6.11) were more likely in men with osteoporosis. Hypercortisolism and hyperthyroidism were uncommon and not significantly more frequent in men with osteoporosis. No osteoporotic men had hypercalciuria. Conclusions Though most of these older men had ≥1 laboratory abnormality, few routinely recommended individual tests were more common in men with osteoporosis than in those without osteoporosis. Possibly excepting vitamin D and alkaline phosphatase, benefit of routine laboratory testing to identify possible secondary causes in older osteoporotic men appears low. Results may not be generalizable to younger men or to older men in whom history and exam findings raise clinical suspicion for a secondary cause of osteoporosis. PMID:26458388

Evaluation of an inhouse rapid ELISA test for detection of giardia in domestic sheep (Ovis aries).

PubMed

Wilson, Jolaine M; Hankenson, F Claire

2010-11-01

Sheep (Ovis aries) are increasingly used at our institution as models of human disease. Within the research environment, routine husbandry and handling of sheep has potential for transmission of zoonotic agents, including Giardia. The prevalence of Giardia in sheep may approach 68%. Classic diagnostic testing involves microscopic examination for fecal cysts or trophozoites; however, limitations of microscopy include time, labor, and potential false-negative results due to intermittent shedding. We wished to determine whether a commercial rapid ELISA used for Giardia detection in dogs and cats could be used in sheep. Fecal samples collected from sheep (n = 93) were tested with a combination of 6 methods: reference laboratory fecal flotation, reference laboratory ELISA, inhouse fecal flotation, and commercially available tests (enzyme immunoassay, direct fluorescence antibody assay, and rapid ELISA). Prevalence of Giardia infection in facility sheep was 11.8% (11 of 93 animals). Of the 11 samples considered positive, 3 were confirmed by multiple testing methods, and 5 were positive by microscopy alone. Inhouse fecal flotation for 8 samples was positive on only 1 of 2 consecutive testing days. The rapid ELISA test exhibited 0% sensitivity for sheep giardiasis. Overall, the examined methods had low sensitivities and low positive predictive values. Despite limitations, microscopic analysis of repeat fecal samples remained the most accurate diagnostic method for ovine giardiasis among the methods tested.

District, state or regional veterinary diagnostic laboratories.

PubMed

Gosser, H S; Morehouse, L G

1998-08-01

The district, regional or state laboratory is the local laboratory to which veterinarian practitioners usually submit samples, and consequently these laboratories are usually the first to observe a suspected disease problem. In most countries, these laboratories are under the jurisdiction of the State or region in which they are located. In the United States of America (USA), most veterinary diagnostic laboratories are State-associated and operate under the aegis of either the State Department of Agriculture or a university. The national laboratory provides reference assistance to the State laboratories. In the USA, the national Laboratory (the National Veterinary Services Laboratories) acts as a consultant to confirm difficult diagnoses and administer performance tests for State-associated laboratories. District, state or regional laboratories need to share information regarding technological advances in diagnostic procedures. This need was met in the USA by the formation of the American Association of Veterinary Laboratory Diagnosticians (AAVLD) in the late 1950s. Another requirement of district, state or regional diagnostic laboratories is a method to confirm quality assurance, which was fulfilled in the USA by an accreditation programme established through the AAVLD. The Accreditation Committee evaluates laboratories (on request) in terms of organisation, personnel, physical facilities and equipment, records, finance and budget. Those laboratories which meet the standards as established in the 'Essential Requirements for Accreditation' are given accreditation status, which indicates that they have the expertise and facilities to perform tests on food-producing animals for shipment in national or international commerce and on companion, laboratory or zoo animals. While confidentiality of test records is most important, it is becoming necessary to release certain types of animal disease test information if a country is to participate in the exportation of animals and animal products. As district, state and regional laboratories operate under many different administrative entities (i.e., universities, State governments and the Federal government), various checks at different administrative levels provide safeguards and reduce the possibility of faulty disease reporting.

A Lean Six Sigma approach to the improvement of the selenium analysis method.

PubMed

Cloete, Bronwyn C; Bester, André

2012-11-02

Reliable results represent the pinnacle assessment of quality of an analytical laboratory, and therefore variability is considered to be a critical quality problem associated with the selenium analysis method executed at Western Cape Provincial Veterinary Laboratory (WCPVL). The elimination and control of variability is undoubtedly of significant importance because of the narrow margin of safety between toxic and deficient doses of the trace element for good animal health. A quality methodology known as Lean Six Sigma was believed to present the most feasible solution for overcoming the adverse effect of variation, through steps towards analytical process improvement. Lean Six Sigma represents a form of scientific method type, which is empirical, inductive and deductive, and systematic, which relies on data, and is fact-based. The Lean Six Sigma methodology comprises five macro-phases, namely Define, Measure, Analyse, Improve and Control (DMAIC). Both qualitative and quantitative laboratory data were collected in terms of these phases. Qualitative data were collected by using quality-tools, namely an Ishikawa diagram, a Pareto chart, Kaizen analysis and a Failure Mode Effect analysis tool. Quantitative laboratory data, based on the analytical chemistry test method, were collected through a controlled experiment. The controlled experiment entailed 13 replicated runs of the selenium test method, whereby 11 samples were repetitively analysed, whilst Certified Reference Material (CRM) was also included in 6 of the runs. Laboratory results obtained from the controlled experiment was analysed by using statistical methods, commonly associated with quality validation of chemistry procedures. Analysis of both sets of data yielded an improved selenium analysis method, believed to provide greater reliability of results, in addition to a greatly reduced cycle time and superior control features. Lean Six Sigma may therefore be regarded as a valuable tool in any laboratory, and represents both a management discipline, and a standardised approach to problem solving and process optimisation.

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.

Determination of dissolved oxygen in the cryosphere: a comprehensive laboratory and field evaluation of fiber optic sensors.

PubMed

Bagshaw, E A; Wadham, J L; Mowlem, M; Tranter, M; Eveness, J; Fountain, A G; Telling, J

2011-01-15

Recent advances in the Cryospheric Sciences have shown that icy environments are host to consortia of microbial communities, whose function and dynamics are often controlled by the concentrations of dissolved oxygen (DO) in solution. To date, only limited spot determinations of DO have been possible in these environments. They reveal the potential for rates of change that exceed realistic manual sampling rates, highlighting the need to explore methods for the continuous measurement of DO concentrations. We report the first comprehensive field and laboratory performance tests of fiber-optic sensors (PreSens, Regensburg, Germany) for measuring DO in icy ecosystems. A series of laboratory tests performed at low and standard temperatures (-5 to 20 °C) demonstrates high precision (0.3% at 50 μmol/kg and 1.3% at 300 μmol/kg), rapid response times (<20 s), and minimal drift (<0.4%). Survival of freeze thaw was problematic, unless the sensor film was mechanically fixed to the fiber and protected by a stainless steel sheath. Results of two field deployments of sensors to the Swiss Alps and Antarctica largely demonstrate a performance consistent with laboratory tests and superior to traditional methods.

Analysis of negative historical control group data from the in vitro micronucleus assay using TK6 cells.

PubMed

Lovell, David P; Fellows, Mick; Marchetti, Francesco; Christiansen, Joan; Elhajouji, Azeddine; Hashimoto, Kiyohiro; Kasamoto, Sawako; Li, Yan; Masayasu, Ozaki; Moore, Martha M; Schuler, Maik; Smith, Robert; Stankowski, Leon F; Tanaka, Jin; Tanir, Jennifer Y; Thybaud, Veronique; Van Goethem, Freddy; Whitwell, James

2018-01-01

The recent revisions of the Organisation for Economic Co-operation and Development (OECD) genetic toxicology test guidelines emphasize the importance of historical negative controls both for data quality and interpretation. The goal of a HESI Genetic Toxicology Technical Committee (GTTC) workgroup was to collect data from participating laboratories and to conduct a statistical analysis to understand and publish the range of values that are normally seen in experienced laboratories using TK6 cells to conduct the in vitro micronucleus assay. Data from negative control samples from in vitro micronucleus assays using TK6 cells from 13 laboratories were collected using a standard collection form. Although in some cases statistically significant differences can be seen within laboratories for different test conditions, they were very small. The mean incidence of micronucleated cells/1000 cells ranged from 3.2/1000 to 13.8/1000. These almost four-fold differences in micronucleus levels cannot be explained by differences in scoring method, presence or absence of exogenous metabolic activation (S9), length of treatment, presence or absence of cytochalasin B or different solvents used as vehicles. The range of means from the four laboratories using flow cytometry methods (3.7-fold: 3.5-12.9 micronucleated cells/1000 cells) was similar to that from the nine laboratories using other scoring methods (4.3-fold: 3.2-13.8 micronucleated cells/1000 cells). No laboratory could be identified as an outlier or as showing unacceptably high variability. Quality Control (QC) methods applied to analyse the intra-laboratory variability showed that there was evidence of inter-experimental variability greater than would be expected by chance (i.e. over-dispersion). However, in general, this was low. This study demonstrates the value of QC methods in helping to analyse the reproducibility of results, building up a 'normal' range of values, and as an aid to identify variability within a laboratory in order to implement processes to maintain and improve uniformity. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Hematology and pathology devices; reclassification; restricted devices; OTC test sample collection systems for drugs of abuse testing. Food and Drug Administration, HHS. Final rule.

PubMed

2000-04-07

The Food and Drug Administration (FDA) is reclassifying over-the-counter (OTC) test sample collection systems for drugs of abuse testing from class III (premarket approval) into class I (general controls) and exempting them from premarket notification (510(k)) and current good manufacturing practice (CGMP) requirements. FDA is also designating OTC test sample collection systems for drugs of abuse testing as restricted devices under the Federal Food, Drug, and Cosmetic Act (the act) and establishing restrictions intended to assure consumers that: The underlying laboratory test(s) are accurate and reliable; the laboratory performing the test(s) has adequate expertise and competency; and the product has adequate labeling and methods of communicating test results to consumers. Finally, FDA is adding a conforming amendment to the existing classification regulation for specimen transport and storage containers to clarify that it does not apply to specimen transport and storage containers that are part of an OTC test sample collection system for the purpose of testing for the presence of drugs of abuse or their metabolites in a laboratory.

CERTS Microgrid Laboratory Test Bed - PIER Final Project Report

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

Eto, Joseph H.; Eto, Joseph H.; Lasseter, Robert

2008-07-25

The objective of the CERTS Microgrid Laboratory Test Bed project was to enhance the ease of integrating small energy sources into a microgrid. The project accomplished this objective by developing and demonstrating three advanced techniques, collectively referred to as the CERTS Microgrid concept, that significantly reduce the level of custom field engineering needed to operate microgrids consisting of small generating sources. The techniques comprising the CERTS Microgrid concept are: 1) a method for effecting automatic and seamless transitions between grid-connected and islanded modes of operation; 2) an approach to electrical protection within the microgrid that does not depend on highmore » fault currents; and 3) a method for microgrid control that achieves voltage and frequency stability under islanded conditions without requiring high-speed communications. The techniques were demonstrated at a full-scale test bed built near Columbus, Ohio and operated by American Electric Power. The testing fully confirmed earlier research that had been conducted initially through analytical simulations, then through laboratory emulations, and finally through factory acceptance testing of individual microgrid components. The islanding and resychronization method met all Institute of Electrical and Electronics Engineers 1547 and power quality requirements. The electrical protections system was able to distinguish between normal and faulted operation. The controls were found to be robust and under all conditions, including difficult motor starts. The results from these test are expected to lead to additional testing of enhancements to the basic techniques at the test bed to improve the business case for microgrid technologies, as well to field demonstrations involving microgrids that involve one or mroe of the CERTS Microgrid concepts.« less

Emergency Physicians’ Views of Direct Notification of Laboratory and Radiology Results to Patients Using the Internet: A Multisite Survey

PubMed Central

2015-01-01

Background Patients are increasingly using the Internet to communicate with health care providers and access general and personal health information. Missed test results have been identified as a critical safety issue with studies showing up to 75% of tests for emergency department (ED) patients not being followed-up. One strategy that could reduce the likelihood of important results being missed is for ED patients to have direct access to their test results. This could be achieved electronically using a patient portal tied to the hospital’s electronic medical record or accessed from the relevant laboratory information system. Patients have expressed interest in accessing test results directly, but there have been no reported studies on emergency physicians’ opinions. Objective The aim was to explore emergency physicians’ current practices of test result notification and attitudes to direct patient notification of clinically significant abnormal and normal test results. Methods A cross-sectional survey was self-administered by senior emergency physicians (site A: n=50; site B: n=39) at 2 large public metropolitan teaching hospitals in Australia. Outcome measures included current practices for notification of results (timing, methods, and responsibilities) and concerns with direct notification. Results The response rate was 69% (61/89). More than half of the emergency physicians (54%, 33/61) were uncomfortable with patients receiving direct notification of abnormal test results. A similar proportion (57%, 35/61) was comfortable with direct notification of normal test results. Physicians were more likely to agree with direct notification of normal test results if they believed it would reduce their workload (OR 5.72, 95% CI 1.14-39.76). Main concerns were that patients could be anxious (85%, 52/61), confused (92%, 56/61), and lacking in the necessary expertise to interpret their results (90%, 55/61). Conclusions Although patients’ direct access to test results could serve as a safety net reducing the likelihood of abnormal results being missed, emergency physicians’ concerns need further exploration: which results are suitable and the timing and method of direct release to patients. Methods of access, including secure Web-based patient portals with drill-down facilities providing test descriptions and result interpretations, or laboratories sending results directly to patients, need evaluation to ensure patient safety is not compromised and the processes fit with ED clinician and laboratory work practices and patient needs. PMID:25739322

Field demonstration of on-site analytical methods for TNT and RDX in ground water

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

Craig, H.; Ferguson, G.; Markos, A.

1996-12-31

A field demonstration was conducted to assess the performance of eight commercially-available and emerging colorimetric, immunoassay, and biosensor on-site analytical methods for explosives 2,4,6-trinitrotoluene (TNT) and hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX) in ground water and leachate at the Umatilla Army Depot Activity, Hermiston, Oregon and US Naval Submarine Base, Bangor, Washington, Superfund sites. Ground water samples were analyzed by each of the on-site methods and results compared to laboratory analysis using high performance liquid chromatography (HPLC) with EPA SW-846 Method 8330. The commercial methods evaluated include the EnSys, Inc., TNT and RDX colorimetric test kits (EPA SW-846 Methods 8515 and 8510) with amore » solid phase extraction (SPE) step, the DTECH/EM Science TNT and RDX immunoassay test kits (EPA SW-846 Methods 4050 and 4051), and the Ohmicron TNT immunoassay test kit. The emerging methods tested include the antibody-based Naval Research Laboratory (NRL) Continuous Flow Immunosensor (CFI) for TNT and RDX, and the Fiber Optic Biosensor (FOB) for TNT. Accuracy of the on-site methods were evaluated using linear regression analysis and relative percent difference (RPD) comparison criteria. Over the range of conditions tested, the colorimetric methods for TNT and RDX showed the highest accuracy of the emerging methods for TNT and RDX. The colorimetric method was selected for routine ground water monitoring at the Umatilla site, and further field testing on the NRL CFI and FOB biosensors will continue at both Superfund sites.« less

Validation of an In Vitro Sun Protection Factor (SPF) method in blinded ring-testing.

PubMed

Pissavini, M; Tricaud, C; Wiener, G; Lauer, A; Contier, M; Kolbe, L; Trullás Cabanas, C; Boyer, F; Nollent, V; Meredith, E; Dietrich, E; Matts, P J

2018-04-20

The objective of this work was to investigate the utility of a new in vitro SPF test method in blinded ring-testing, against new ISO acceptance criteria. 24 blinded, commercial, emulsion-type, primary sunscreen products, covering the full range of labelled SPF in Europe (SPF6 - 50+), were tested by 3 test institutes using the current ISO24444:2010 In Vivo SPF Test Method and simultaneously by 3 separate test laboratories using a new candidate in vitro SPF test method, developed under the leadership of Cosmetics Europe (CE). The resulting relationship between in vitro SPF and in vivo SPF values was then compared with acceptance criteria developed recently by the International Standards (ISO) TC217 / WG7 Sun Protection Test Methods Working Group. Analysis of the mean inter-laboratory in vitro and mean inter-institute in vivo SPF values revealed a strong correlation between in vitro and in vivo values, with a Pearson correlation coefficient of r 2 =0.88 (p<0.0001), a slope of 1.01 and a non-significant intercept (-1.48; p=0.62). When these data were compared to the new ISO WG7 acceptance criteria, method bias was found to be extremely low and over 95% of the coupled data lay within the model "funnel" (defined by upper and lower confidence intervals). In conclusion, the results of blinded ring testing and comparison to new ISO WG7 acceptance criteria indicate that a new in vitro SPF test method meets (and exceeds) these minimum criteria and is an interesting candidate for possible deployment as an industry test methodology. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Benchmarking in pathology: development of an activity-based costing model.

PubMed

Burnett, Leslie; Wilson, Roger; Pfeffer, Sally; Lowry, John

2012-12-01

Benchmarking in Pathology (BiP) allows pathology laboratories to determine the unit cost of all laboratory tests and procedures, and also provides organisational productivity indices allowing comparisons of performance with other BiP participants. We describe 14 years of progressive enhancement to a BiP program, including the implementation of 'avoidable costs' as the accounting basis for allocation of costs rather than previous approaches using 'total costs'. A hierarchical tree-structured activity-based costing model distributes 'avoidable costs' attributable to the pathology activities component of a pathology laboratory operation. The hierarchical tree model permits costs to be allocated across multiple laboratory sites and organisational structures. This has enabled benchmarking on a number of levels, including test profiles and non-testing related workload activities. The development of methods for dealing with variable cost inputs, allocation of indirect costs using imputation techniques, panels of tests, and blood-bank record keeping, have been successfully integrated into the costing model. A variety of laboratory management reports are produced, including the 'cost per test' of each pathology 'test' output. Benchmarking comparisons may be undertaken at any and all of the 'cost per test' and 'cost per Benchmarking Complexity Unit' level, 'discipline/department' (sub-specialty) level, or overall laboratory/site and organisational levels. We have completed development of a national BiP program. An activity-based costing methodology based on avoidable costs overcomes many problems of previous benchmarking studies based on total costs. The use of benchmarking complexity adjustment permits correction for varying test-mix and diagnostic complexity between laboratories. Use of iterative communication strategies with program participants can overcome many obstacles and lead to innovations.

The ideal laboratory information system.

PubMed

Sepulveda, Jorge L; Young, Donald S

2013-08-01

Laboratory information systems (LIS) are critical components of the operation of clinical laboratories. However, the functionalities of LIS have lagged significantly behind the capacities of current hardware and software technologies, while the complexity of the information produced by clinical laboratories has been increasing over time and will soon undergo rapid expansion with the use of new, high-throughput and high-dimensionality laboratory tests. In the broadest sense, LIS are essential to manage the flow of information between health care providers, patients, and laboratories and should be designed to optimize not only laboratory operations but also personalized clinical care. To list suggestions for designing LIS with the goal of optimizing the operation of clinical laboratories while improving clinical care by intelligent management of laboratory information. Literature review, interviews with laboratory users, and personal experience and opinion. Laboratory information systems can improve laboratory operations and improve patient care. Specific suggestions for improving the function of LIS are listed under the following sections: (1) Information Security, (2) Test Ordering, (3) Specimen Collection, Accessioning, and Processing, (4) Analytic Phase, (5) Result Entry and Validation, (6) Result Reporting, (7) Notification Management, (8) Data Mining and Cross-sectional Reports, (9) Method Validation, (10) Quality Management, (11) Administrative and Financial Issues, and (12) Other Operational Issues.

LAPR: An experimental aircraft pushbroom scanner

NASA Technical Reports Server (NTRS)

Wharton, S. W.; Irons, J. I.; Heugel, F.

1980-01-01

A three band Linear Array Pushbroom Radiometer (LAPR) was built and flown on an experimental basis by NASA at the Goddard Space Flight Center. The functional characteristics of the instrument and the methods used to preprocess the data, including radiometric correction, are described. The radiometric sensitivity of the instrument was tested and compared to that of the Thematic Mapper and the Multispectral Scanner. The radiometric correction procedure was evaluated quantitatively, using laboratory testing, and qualitatively, via visual examination of the LAPR test flight imagery. Although effective radiometric correction could not yet be demonstrated via laboratory testing, radiometric distortion did not preclude the visual interpretation or parallel piped classification of the test imagery.

A thesis on the Development of an Automated SWIFT Edge Detection Algorithm

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

Trujillo, Christopher J.

Throughout the world, scientists and engineers such as those at Los Alamos National Laboratory, perform research and testing unique only to applications aimed towards advancing technology, and understanding the nature of materials. With this testing, comes a need for advanced methods of data acquisition and most importantly, a means of analyzing and extracting the necessary information from such acquired data. In this thesis, I aim to produce an automated method implementing advanced image processing techniques and tools to analyze SWIFT image datasets for Detonator Technology at Los Alamos National Laboratory. Such an effective method for edge detection and point extractionmore » can prove to be advantageous in analyzing such unique datasets and provide for consistency in producing results.« less

[The diagnostic methods applied in mycology].

PubMed

Kurnatowska, Alicja; Kurnatowski, Piotr

2008-01-01

The systemic fungal invasions are recognized with increasing frequency and constitute a primary cause of morbidity and mortality, especially in immunocompromised patients. Early diagnosis improves prognosis, but remains a problem because there is lack of sensitive tests to aid in the diagnosis of systemic mycoses on the one hand, and on the other the patients only present unspecific signs and symptoms, thus delaying early diagnosis. The diagnosis depends upon a combination of clinical observation and laboratory investigation. The successful laboratory diagnosis of fungal infection depends in major part on the collection of appropriate clinical specimens for investigations and on the selection of appropriate microbiological test procedures. So these problems (collection of specimens, direct techniques, staining methods, cultures on different media and non-culture-based methods) are presented in article.

Fast preparation of a long chimeric armored RNA as controls for external quality assessment for molecular detection of Zika virus.

PubMed

Lin, Guigao; Zhang, Kuo; Zhang, Dong; Han, Yanxi; Xie, Jiehong; Li, Jinming

2017-03-01

The emergence of Zika virus demands accurate laboratory diagnostics. Nucleic acid testing is currently the definitive method for diagnosis of Zika infection. In 2016, an external quality assurance (EQA) for assessing the quality of molecular testing of Zika virus was carried out in China. A single armored RNA encapsulating a 4942-nucleotides (nt) long specific RNA sequence of Zika virus was prepared and used as positive samples. A pre-tested EQA panel, consisting of 4 negative and 6 positive samples with different concentrations of armored RNA, was distributed to 38 laboratories that perform molecular detection of Zika virus. A total of 39 data sets (1 laboratory used two test kits in parallel), produced by using commercial (n=38) or laboratory developed (n=1) quantitative reverse-transcriptase PCR (qRT-PCR) kits, were received. Of these, 35 (89.7%) had correct results for all 10 samples, and 4 (10.3%) reported at least 1 error (11 in total). The testing errors were all false-negatives, highlighting the need of improvements in detecting sensitivity. The EQA reveals that the majority of participating laboratories are proficient in molecular testing of Zika virus. Copyright © 2017 Elsevier B.V. All rights reserved.

Comparison of Different Methods to Identify tdh-Positive Pathogenic Vibrio parahaemolyticus Isolates.

PubMed

Zhang, Hongzhi; Chen, Min

2018-01-01

We evaluated the accuracy and ease of operation of three methods to identify tdh-positive Vibrio parahaemolyticus isolates, including the Kanagawa phenomenon test (KP test), a tdh gene PCR test, and a colloidal gold immunochromatographic assay (CGIA). A total of 221 V. parahaemolyticus isolates were collected from patients, freshly harvested seafood, and fresh seawater. Using the KP test, 92% of V. parahaemolyticus isolates from patients were identified tdh-positive, including four weak KP-positive isolates. The PCR test and CGIA also identified 92% of the isolates as tdh-positive. However, PCR and CGIA only confirmed one of the four weak KP-positive isolates. Similar results were obtained using the three methods to identify V. parahaemolyticus isolates from the other sources. Among the three methods, the KP test was the simplest to perform because it lacked any requirement for sample pretreatment, and was low cost, with no equipment requirements. Therefore, the KP test has been applied widely in many first-line quarantine laboratories. However, the sensitivity and accuracy of KP test were lower than those of the other two methods. PCR can identify the tdh rapidly, specifically, and sensitively. However, PCR requires equipment and facilities that are unavailable in first-line quarantine laboratories. The CGIA can compensate for the disadvantages of the other two methods by its higher sensitivity, accuracy, and ease of operation. Therefore, the CGIA has the highest potential to be used to identify tdh-positive V. parahaemolyticus isolates to guarantee food safety.

HSRP and HSRP Partner Analytical Methods and Protocols

EPA Pesticide Factsheets

HSRP has worked with various partners to develop and test analytical methods and protocols for use by laboratories charged with analyzing environmental and/or buildling material samples following contamination incident.

Space Systems - Safety and Compatibility of Materials - Method to Determine the Flammability Thresholds of Materials

NASA Technical Reports Server (NTRS)

Hirsch, David

2009-01-01

Spacecraft fire safety emphasizes fire prevention, which is achieved primarily through the use of fire-resistant materials. Materials selection for spacecraft is based on conventional flammability acceptance tests, along with prescribed quantity limitations and configuration control for items that are non-pass or questionable. ISO 14624-1 and -2 are the major methods used to evaluate flammability of polymeric materials intended for use in the habitable environments of spacecraft. The methods are upward flame-propagation tests initiated in static environments and using a well-defined igniter flame at the bottom of the sample. The tests are conducted in the most severe flaming combustion environment expected in the spacecraft. The pass/fail test logic of ISO 14624-1 and -2 does not allow a quantitative comparison with reduced gravity or microgravity test results; therefore their use is limited, and possibilities for in-depth theoretical analyses and realistic estimates of spacecraft fire extinguishment requirements are practically eliminated. To better understand the applicability of laboratory test data to actual spacecraft environments, a modified ISO 14624 protocol has been proposed that, as an alternative to qualifying materials as pass/fail in the worst-expected environments, measures the actual upward flammability limit for the material. A working group established by NASA to provide recommendations for exploration spacecraft internal atmospheres realized the importance of correlating laboratory data with real-life environments and recommended NASA to develop a flammability threshold test method. The working group indicated that for the Constellation Program, the flammability threshold information will allow NASA to identify materials with increased flammability risk from oxygen concentration and total pressure changes, minimize potential impacts, and allow for development of sound requirements for new spacecraft and extravehicular landers and habitats. Furthermore, recent research has shown that current normal gravity materials flammability tests do not correlate with flammability in ventilated, micro- or reduced-gravity conditions. Currently, the materials selection for spacecraft is based on the assumption of commonality between ground flammability test results and spacecraft environments, which does not appear to be valid. Materials flammability threshold data acquired in normal gravity can be correlated with data obtained in microgravity or reduced-gravity experiments, and consequently a more accurate assessment of the margin of safety of the material in the real environment can be made. In addition, the method allows the option of selecting better or best space system materials, as opposed to what would be considered just acceptable from a flammability point of view and realistic assessment of spacecraft fire extinguishment needs, which could result in significant weight savings. The knowledge afforded by this technique allows for limited extrapolations of flammability behavior to conditions not specifically tested and that could potentially result in significant cost and time savings. The intent of this Technical Specification is to bring to the attention of International Aerospace Community the importance of correlating laboratory test data with real-life space systems applications. The method presented is just one of the possibilities that are believed will lead to better understanding the applicability of laboratory aerospace materials flammability test data. International feedback on improving the proposed method, as well as suggestions for correlating other laboratory aerospace test data with real-life applications relevant to space systems are being sought.

[AT THE CROSSROADS: THE ROLE OF LABORATORY MEDICINE IN THE PATIENT CARE PROCESS].

PubMed

Geffen, Yuval; Zaidise, Itzhak

2017-06-01

In recent decades, the laboratory medicine profession has undergone significant changes due to both technological developments and economic constraints. Technological innovations support automation, provide faster and more accurate equipment, and allow increased efficiency through the use of commercial test kits. These changes, combined with budgetary constraints, have led to mergers and centralization of medical laboratories to optimize work and cut costs. While this centralization may be a business necessity, it leads to a disconnection between the laboratory and the clinical context. In addition, laboratory tests are treated as a commodity, which places emphasis on price only, rather than quality. In this article, we review the developments and changes that medical laboratories and the laboratory medicine profession have undergone in recent decades. We focus on technological and structural challenges affecting the functioning of medical laboratories and the relations between laboratory workers and medical teams. We then introduce vocational education changes required for the laboratory medicine profession. We propose defining the role of medical laboratory directors in terms of their basic training as medical doctors or doctors of science. We suggest that laboratory employees should become a reliable source of information regarding selection of appropriate test methods, processing data and presenting the results to the medical staff. Laboratory workers must deepen their clinical knowledge and become an integral part of the patient care process, along with medical and nursing staff. Special training programs for medical laboratory workers and directors must be developed in order to match the complex activities currently being conducted in laboratories.

40 CFR 136.6 - Method modifications and analytical requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... person or laboratory using a test procedure (analytical method) in this Part. (2) Chemistry of the method... (analytical method) provided that the chemistry of the method or the determinative technique is not changed... prevent efficient recovery of organic pollutants and prevent the method from meeting QC requirements, the...

Evaluation of first-draw whole blood, point-of-care cardiac markers in the context of the universal definition of myocardial infarction: a comparison of a multimarker panel to troponin alone and to testing in the central laboratory.

PubMed

Lee-Lewandrowski, Elizabeth; Januzzi, James L; Grisson, Ricky; Mohammed, Asim A; Lewandrowski, Grant; Lewandrowski, Kent

2011-04-01

Previous studies evaluating point-of-care testing (POCT) for cardiac biomarkers did not use current recommendations for troponin cutoff values or recognize the recent universal definition of acute myocardial infarction. Traditionally, achieving optimal sensitivity for the detection of myocardial injury on initial presentation required combining cardiac troponin and/or creatine kinase isoenzyme MB with an early marker, usually myoglobin. In recent years, the performance of central laboratory combining cardiac troponin assays has improved significantly, potentially obviating the need for a multimarker panel to achieve optimum sensitivity. To compare 2 commonly used POCT strategies to a fourth generation, central laboratory cardiac troponin T assay on first-draw specimens from patients being evaluated for acute myocardial infarction in the emergency department. The 2 strategies included a traditional POCT multimarker panel and a newer POCT method using cardiac troponin I alone. Blood specimens from 204 patients presenting to the emergency department with signs and/or symptoms of myocardial ischemia were measured on the 2 POCT systems and by a central laboratory method. The diagnosis for each patient was determined by retrospective chart review. The cardiac troponin T assasy alone was more sensitive for acute myocardial infarction than the multimarker POCT panel with equal or better specificity. When compared with a POCT troponin I, the cardiac troponin T was also more sensitive, but this difference was not significant. The POCT troponin I alone also had the same sensitivity as the multimarker panel. Testing for combining cardiac troponin alone using newer, commercially available, central laboratory or POCT assays performed with equal or greater sensitivity to acute myocardial infarction as the older, traditional, multimarker panel. In the near future, high-sensitivity, central laboratory troponins will be available for routine clinical use. As a result, the quality gap between central laboratories and older POCT methods will continue to widen, unless the performance of the POCT methods is improved.

DNA: The Strand that Connects Us All

ScienceCinema

Kaplan, Matt [Univ. of Arizona, Tucson, AZ (United States). Genetics Core Facility

2018-04-26

Learn how the methods and discoveries of human population genetics are applied for personal genealogical reconstruction and anthropological testing. Dr. Kaplan starts with a short general review of human genetics and the biology behind this form of DNA testing. He looks at how DNA testing is performed and how samples are processed in the University of Arizona laboratory. He also examines examples of personal genealogical results from Family Tree DNA and personal anthropological results from the Genographic Project. Finally, he describes the newest project in the UA laboratory, the DNA Shoah Project.

Barriers and facilitators to reducing frequent laboratory testing for patients who are stable on warfarin: a mixed methods study of de-implementation in five anticoagulation clinics.

PubMed

Barnes, Geoffrey D; Misirliyan, Sevan; Kaatz, Scott; Jackson, Elizabeth A; Haymart, Brian; Kline-Rogers, Eva; Kozlowski, Jay; Krol, Gregory; Froehlich, James B; Sales, Anne

2017-07-14

Patients on chronic warfarin therapy require regular laboratory monitoring to safely manage warfarin. Recent studies have challenged the need for routine monthly blood draws in the most stable warfarin-treated patients, suggesting the safety of less frequent laboratory testing (up to every 12 weeks). De-implementation efforts aim to reduce the use of low-value clinical practices. To explore barriers and facilitators of a de-implementation effort to reduce the use of frequent laboratory tests for patients with stable warfarin management in nurse/pharmacist-run anticoagulation clinics, we performed a mixed-methods study conducted within a state-wide collaborative quality improvement collaborative. Using a mixed-methods approach, we conducted post-implementation semi-structured interviews with a total of eight anticoagulation nurse or pharmacist staff members at five participating clinic sites to assess barriers and facilitators to de-implementing frequent international normalized ratio (INR) laboratory testing among patients with stable warfarin control. Interview guides were based on the Tailored Implementation for Chronic Disease (TICD) framework. Informed by interview themes, a survey was developed and administered to all anticoagulation clinical staff (n = 62) about their self-reported utilization of less frequent INR testing and specific barriers to de-implementing the standard (more frequent) INR testing practice. From the interviews, four themes emerged congruent with TICD domains: (1) staff overestimating their actual use of less frequent INR testing (individual health professional factors), (2) barriers to appropriate patient engagement (incentives and resources), (3) broad support for an electronic medical record flag to identify potentially eligible patients (incentives and resources), and (4) the importance of personalized nurse/pharmacist feedback (individual health professional factors). In the survey (65% response rate), staff report offering less frequent INR testing to 56% (46-66%) of eligible patients. Most survey responders (n = 24; 60%) agreed that an eligibility flag in the electronic medical record would be very helpful. Twenty-four (60%) respondents agreed that periodic, personalized feedback on use of less frequent INR testing would also be helpful. Leveraging information system notifications, reducing additional work load burden for participating patients and providers, and providing personalized feedback are strategies that may improve adoption and utilization new policies in anticoagulation clinics that focus on de-implementation.

HEATED PURGE AND TRAP METHOD DEVELOPMENT AND TESTING

EPA Science Inventory

The goal of the research was to develop a heated purge and trap method that could be used in conjunction with SW-846 method 8240 for the analysis of volatile, water soluble Appendix VIII analytes. The developed method was validated according to a partial single laboratory method ...

Diagnostic methods of TSH in thyroid screening tests.

PubMed

Matyjaszek-Matuszek, Beata; Pyzik, Aleksandra; Nowakowski, Andrzej; Jarosz, Mirosław J

2013-01-01

Reliable and quick thyreologic diagnostics, as well as verification of the effectiveness of the therapy undertaken, is of great importance for the state of health of society. The measurement of plasma TSH is the commonly accepted and most sensitive screening test for primary thyroid disorders, which are the most frequent diseases related to the endocrine glands. At present, the available methods for the determination of TSH are characterized by high sensitivity ≤0.01 µIU/ml and lack of cross-reactivity. However, many drugs and substances, as well as pathological conditions, may affect the TSH level. evaluation of contemporary laboratory methods for the determination of TSH and the principles of interpretation of screening tests. In many countries, the TSH test is the only test performed in the diagnostics of thyroid function; nevertheless, it seems that for genuine and objective assessment of thyroid status the TSH level, together with FT4 level, should be absolutely determined, which allows the differentiation and assessment of the intensity of thyroid function disorders and foresee its consequences. The interpretation of TSH results in screening tests is different in such population groups as: children aged under 14, pregnant women, the elderly, and patients with non-thyroidal illnesses. From among currently used laboratory methods for determination of TSH levels, third generation non-isotopic methods are most frequently recommended, especially the method of immunochemiluminescence.

Alkali deposits found in biomass power plants: A preliminary investigation of their extent and nature. Volume 1

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

Miles, T.R.; Miles, T.R. Jr.; Baxter, L.L.

1995-04-15

Alkali in the ash of annual crop biomass fuels creates serious fouling and slagging in conventional boilers. Even with the use of sorbents and other additives, power plants can only fire limited amounts of these fuels in combination with wood. The National Renewable Energy Laboratory (NREL), US Department of Energy, and the biomass power industry carried out eight full-scale firing tests and several laboratory experiments to study the nature and occurrence of deposits with the goal of increasing the quantities of these biofuels that can be used. This report describes the results of the laboratory and power plant tests thatmore » included: tracking and analyzing fuels and deposits by various methods; recording operating conditions; and extensive laboratory testing. The paper describes the occurrence of deposits, fuel and deposit analyses, boiler design and operation, fouling and slagging indicators, and recommendations. 37 refs., 41 figs., 17 tabs.« less

Los Alamos and Lawrence Livermore National Laboratories Code-to-Code Comparison of Inter Lab Test Problem 1 for Asteroid Impact Hazard Mitigation

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

Weaver, Robert P.; Miller, Paul; Howley, Kirsten

The NNSA Laboratories have entered into an interagency collaboration with the National Aeronautics and Space Administration (NASA) to explore strategies for prevention of Earth impacts by asteroids. Assessment of such strategies relies upon use of sophisticated multi-physics simulation codes. This document describes the task of verifying and cross-validating, between Lawrence Livermore National Laboratory (LLNL) and Los Alamos National Laboratory (LANL), modeling capabilities and methods to be employed as part of the NNSA-NASA collaboration. The approach has been to develop a set of test problems and then to compare and contrast results obtained by use of a suite of codes, includingmore » MCNP, RAGE, Mercury, Ares, and Spheral. This document provides a short description of the codes, an overview of the idealized test problems, and discussion of the results for deflection by kinetic impactors and stand-off nuclear explosions.« less

Virtual laboratory learning media development to improve science literacy skills of mechanical engineering students on basic physics concept of material measurement

NASA Astrophysics Data System (ADS)

Jannati, E. D.; Setiawan, A.; Siahaan, P.; Rochman, C.

2018-05-01

This study aims to determine the description of virtual laboratory learning media development to improve science literacy skills of Mechanical Engineering students on the concept of basic Physics. Quasi experimental method was employed in this research. The participants of this research were first semester students of mechanical engineering in Majalengka University. The research instrument was readability test of instructional media. The results of virtual laboratory learning media readability test show that the average score is 78.5%. It indicates that virtual laboratory learning media development are feasible to be used in improving science literacy skill of Mechanical Engineering students in Majalengka University, specifically on basic Physics concepts of material measurement.

Use of Lean Response to Improve Pandemic Influenza Surge in Public Health Laboratories

PubMed Central

Chang, Yin; Prystajecky, Natalie; Petric, Martin; Mak, Annie; Abbott, Brendan; Paris, Benjamin; Decker, K.C.; Pittenger, Lauren; Guercio, Steven; Stott, Jeff; Miller, Joseph D.

2012-01-01

A novel influenza A (H1N1) virus detected in April 2009 rapidly spread around the world. North American provincial and state laboratories have well-defined roles and responsibilities, including providing accurate, timely test results for patients and information for regional public health and other decision makers. We used the multidisciplinary response and rapid implementation of process changes based on Lean methods at the provincial public health laboratory in British Columbia, Canada, to improve laboratory surge capacity in the 2009 influenza pandemic. Observed and computer simulating evaluation results from rapid processes changes showed that use of Lean tools successfully expanded surge capacity, which enabled response to the 10-fold increase in testing demands. PMID:22257385

Current Landscape and New Paradigms of Proficiency Testing and External Quality Assessment for Molecular Genetics

PubMed Central

Kalman, Lisa V.; Lubin, Ira M.; Barker, Shannon; du Sart, Desiree; Elles, Rob; Grody, Wayne W.; Pazzagli, Mario; Richards, Sue; Schrijver, Iris; Zehnbauer, Barbara

2015-01-01

Context Participation in proficiency testing (PT) or external quality assessment (EQA) programs allows the assessment and comparison of test performance among different clinical laboratories and technologies. In addition to the approximately 2300 tests for individual genetic disorders, recent advances in technology have enabled the development of clinical tests which quickly and economically analyze the entire human genome. New PT/EQA approaches are needed to ensure the continued quality of these complex tests. Objective To review the availability and scope of PT/EQA for molecular genetic testing for inherited conditions in Europe, Australasia and the United States; to evaluate the successes and demonstrated value of available PT/EQA programs; and to examine the challenges to the provision of comprehensive PT/EQA posed by new laboratory practices and methodologies. Data Sources The available literature on this topic was reviewed and supplemented with personal experiences of several PT/EQA providers. Conclusions PT/EQA schemes are available for common genetic disorders tested in many clinical laboratories, but are not available for most genetic tests offered by only one or a few laboratories. Provision of broad, method-based PT schemes, such as DNA sequencing, would allow assessment of a large number of tests for which formal PT is not currently available. Participation in PT/EQA improves the quality of testing by identifying inaccuracies that laboratories can trace to errors in the testing process. Areas of research and development to ensure that PT/EQA programs can meet the needs of new and evolving genetic tests and technologies are identified and discussed. PMID:23808472

[External quality control system in medical microbiology and parasitology in the Czech Republic].

PubMed

Slosárek, M; Petrás, P; Kríz, B

2004-11-01

The External Quality Control System (EQAS) of laboratory activities in medical microbiology and parasitology was implemented in the Czech Republic in 1993 with coded sera samples for diagnosis of viral hepatitis and bacterial strains for identification distributed to first participating laboratories. The number of sample types reached 31 in 2003 and the number of participating laboratories rised from 79 in 1993 to 421 in 2003. As many as 15.130 samples were distributed to the participating laboratories in 2003. Currently, almost all microbiology and parasitology laboratories in the Czech Republic involved in examination of clinical material participate in the EQAS. Based on the 11-year experience gained with the EQAS in the Czech Republic, the following benefits were observed: higher accuracy of results in different tests, standardisation of methods and the use of most suitable test kits.

Clean Water Act Analytical Methods

EPA Pesticide Factsheets

EPA publishes laboratory analytical methods (test procedures) that are used by industries and municipalities to analyze the chemical, physical and biological components of wastewater and other environmental samples required by the Clean Water Act.

Intra- and interlaboratory variability in acute toxicity tests with glochidia and juveniles of freshwater mussels (Unionidae)

USGS Publications Warehouse

Wang, N.; Augspurger, T.; Barnhart, M.C.; Bidwell, Joseph R.; Cope, W.G.; Dwyer, F.J.; Geis, S.; Greer, I.E.; Ingersoll, C.G.; Kane, C.M.; May, T.W.; Neves, R.J.; Newton, T.J.; Roberts, A.D.; Whites, D.W.

2007-01-01

The present study evaluated the performance and variability in acute toxicity tests with glochidia and newly transformed juvenile mussels using the standard methods outlined in American Society for Testing and Materials (ASTM). Multiple 48-h toxicity tests with glochidia and 96-h tests with juvenile mussels were conducted within a single laboratory and among five laboratories. All tests met the test acceptability requirements (e.g., ???90% control survival). Intralaboratory tests were conducted over two consecutive mussel-spawning seasons with mucket (Actinonaias ligamentina) or fatmucket (Lampsilis siliquoidea) using copper, ammonia, or chlorine as a toxicant. For the glochidia of both species, the variability of intralaboratory median effective concentrations (EC50s) for the three toxicants, expressed as the coefficient of variation (CV), ranged from 14 to 27% in 24-h exposures and from 13 to 36% in 48-h exposures. The intralaboratory CV of copper EC50s for juvenile fatmucket was 24% in 48-h exposures and 13% in 96-h exposures. Interlaboratory tests were conducted with fatmucket glochidia and juveniles by five laboratories using copper as a toxicant. The interlaboratory CV of copper EC50s for glochidia was 13% in 24-h exposures and 24% in 48-h exposures, and the interlaboratory CV for juveniles was 22% in 48-h exposures and 42% in 96-h exposures. The high completion success and the overall low variability in test results indicate that the test methods have acceptable precision and can be performed routinely. ?? 2007 SETAC.

Development of laboratory test methods to replace the simulated high-temperature grout fluidity test.

DOT National Transportation Integrated Search

2014-06-01

This report contains a summary of the research performed to develop a replacement for the high-temperature grout : fluidity (HTGF) test. The HTGF test was employed in the past by FDOT to qualify post-tensioning (PT) grouts for use in : post-tensioned...

21 CFR 660.43 - Potency test.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Potency test. 660.43 Section 660.43 Food and Drugs... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.43 Potency test... antibody in the appropriate sera of the reference panel by all test methods recommended by the manufacturer...

Current practice in laboratory diagnostics of autoimmune diseases in Croatia. 
Survey of the Working group for laboratory diagnostics of autoimmune diseases of the Croatian Society of Medical Biochemistry and Laboratory Medicine.

PubMed

Kuna, Andrea Tešija; Đerek, Lovorka; Kozmar, Ana; Drvar, Vedrana

2016-10-15

With the trend of increasing incidence of autoimmune diseases, laboratories are faced with exponential growth of the requests for tests relating the diagnosis of these diseases. Unfortunately, the lack of laboratory personnel experienced in this specific discipline of laboratory diagnostic, as well as an unawareness of a method limitation often results in confusion for clinicians. The aim was to gain insight into number and type of Croatian laboratories that perform humoral diagnostics with the final goal to improve and harmonize laboratory diagnostics of autoimmune diseases in Croatia. In order to get insight into current laboratory practice two questionnaires, consisting of 42 questions in total, were created. Surveys were conducted using SurveyMonkey application and were sent to 88 medical biochemistry laboratories in Croatia for the first survey. Out of 33 laboratories that declared to perform diagnostic from the scope, 19 were selected for the second survey based on the tests they pleaded to perform. The survey comprised questions regarding autoantibody hallmarks of systemic autoimmune diseases while regarding organ-specific autoimmune diseases was limited to diseases of liver, gastrointestinal and nervous system. Response rate was high with 80 / 88 (91%) laboratories which answered the first questionnaire, and 19 / 19 (1.0) for the second questionnaire. Obtained results of surveys indicate high heterogeneity in the performance of autoantibody testing among laboratories in Croatia. Results indicate the need of creating recommendations and algorithms in order to harmonize the approach to laboratory diagnostics of autoimmune diseases in Croatia.

Noncontact methods for measuring water-surface elevations and velocities in rivers: Implications for depth and discharge extraction

USGS Publications Warehouse

Nelson, Jonathan M.; Kinzel, Paul J.; McDonald, Richard R.; Schmeeckle, Mark

2016-01-01

Recently developed optical and videographic methods for measuring water-surface properties in a noninvasive manner hold great promise for extracting river hydraulic and bathymetric information. This paper describes such a technique, concentrating on the method of infrared videog- raphy for measuring surface velocities and both acoustic (laboratory-based) and laser-scanning (field-based) techniques for measuring water-surface elevations. In ideal laboratory situations with simple flows, appropriate spatial and temporal averaging results in accurate water-surface elevations and water-surface velocities. In test cases, this accuracy is sufficient to allow direct inversion of the governing equations of motion to produce estimates of depth and discharge. Unlike other optical techniques for determining local depth that rely on transmissivity of the water column (bathymetric lidar, multi/hyperspectral correlation), this method uses only water-surface information, so even deep and/or turbid flows can be investigated. However, significant errors arise in areas of nonhydrostatic spatial accelerations, such as those associated with flow over bedforms or other relatively steep obstacles. Using laboratory measurements for test cases, the cause of these errors is examined and both a simple semi-empirical method and computational results are presented that can potentially reduce bathymetric inversion errors.

Field and laboratory determination of a poly(vinyl/vinylidene chloride) additive in brick mortar.

PubMed

Law, S L; Newman, J H; Ptak, F L

1990-02-01

A polymerized vinyl/vinylidene chloride additive, used in brick mortar during the 60s and 70s, is detected at the building site by the field method, which employs a commercially available chloride test strip. The field test results can then be verified by the laboratory methods. In one method, total chlorine in the mortar is determined by an oxygen-bomb method and the additive chloride is determined by difference after water-soluble chlorides have been determined on a separate sample. In the second method, the polymerized additive is extracted directly from the mortar with tetrahydrofuran (THF). The difference in weight before and after extraction of the additive gives the weight of additive in the mortar. Evaporation of the THF from the extract leaves a thin film of the polymer, which gives an infrared "fingerprint" spectrum characteristic of the additive polymer.

EMQN/CMGS best practice guidelines for the molecular genetic testing of Huntington disease.

PubMed

Losekoot, Monique; van Belzen, Martine J; Seneca, Sara; Bauer, Peter; Stenhouse, Susan A R; Barton, David E

2013-05-01

Huntington disease (HD) is caused by the expansion of an unstable polymorphic trinucleotide (CAG)n repeat in exon 1 of the HTT gene, which translates into an extended polyglutamine tract in the protein. Laboratory diagnosis of HD involves estimation of the number of CAG repeats. Molecular genetic testing for HD is offered in a wide range of laboratories both within and outside the European community. In order to measure the quality and raise the standard of molecular genetic testing in these laboratories, the European Molecular Genetics Quality Network has organized a yearly external quality assessment (EQA) scheme for molecular genetic testing of HD for over 10 years. EQA compares a laboratory's output with a fixed standard both for genotyping and reporting of the results to the referring physicians. In general, the standard of genotyping is very high but the clarity of interpretation and reporting of the test result varies more widely. This emphasizes the need for best practice guidelines for this disorder. We have therefore developed these best practice guidelines for genetic testing for HD to assist in testing and reporting of results. The analytical methods and the potential pitfalls of molecular genetic testing are highlighted and the implications of the different test outcomes for the consultand and his or her family members are discussed.

A laboratory experiment in evaluating means of imparting a harsh texture to portland cement concrete surfaces.

DOT National Transportation Integrated Search

1970-01-01

The purpose of this study was to explore methods of obtaining a rough, durable texture on test slabs fabricated in the laboratory in an attempt to provide high skid resistance. The exploration involved the investigation of types of texture, time of t...

Quicklime specification and test methods

DOT National Transportation Integrated Search

1987-04-01

Samples of pebble quicklime were obtained from each of the six major : lime producers' plants in Texas. These samples were used for laboratory : testing which determined chemical composition of the dry lime, physical : properties of slurries prepared...

Using the failure mode and effects analysis model to improve parathyroid hormone and adrenocorticotropic hormone testing

PubMed Central

Magnezi, Racheli; Hemi, Asaf; Hemi, Rina

2016-01-01

Background Risk management in health care systems applies to all hospital employees and directors as they deal with human life and emergency routines. There is a constant need to decrease risk and increase patient safety in the hospital environment. The purpose of this article is to review the laboratory testing procedures for parathyroid hormone and adrenocorticotropic hormone (which are characterized by short half-lives) and to track failure modes and risks, and offer solutions to prevent them. During a routine quality improvement review at the Endocrine Laboratory in Tel Hashomer Hospital, we discovered these tests are frequently repeated unnecessarily due to multiple failures. The repetition of the tests inconveniences patients and leads to extra work for the laboratory and logistics personnel as well as the nurses and doctors who have to perform many tasks with limited resources. Methods A team of eight staff members accompanied by the Head of the Endocrine Laboratory formed the team for analysis. The failure mode and effects analysis model (FMEA) was used to analyze the laboratory testing procedure and was designed to simplify the process steps and indicate and rank possible failures. Results A total of 23 failure modes were found within the process, 19 of which were ranked by level of severity. The FMEA model prioritizes failures by their risk priority number (RPN). For example, the most serious failure was the delay after the samples were collected from the department (RPN =226.1). Conclusion This model helped us to visualize the process in a simple way. After analyzing the information, solutions were proposed to prevent failures, and a method to completely avoid the top four problems was also developed. PMID:27980440

Highlight on Bottlenecks in Food Allergen Analysis: Detection and Quantification by Mass Spectrometry.

PubMed

Planque, Mélanie; Arnould, Thierry; Renard, Patricia; Delahaut, Philippe; Dieu, Marc; Gillard, Nathlie

2017-07-01

Food laboratories have developed methods for testing allergens in foods. The efficiency of qualitative and quantitative methods is of prime importance in protecting allergic populations. Unfortunately, food laboratories encounter barriers to developing efficient methods. Bottlenecks include the lack of regulatory thresholds, delays in the emergence of reference materials and guidelines, and the need to detect processed allergens. In this study, ultra-HPLC coupled to tandem MS was used to illustrate difficulties encountered in determining method performances. We measured the major influences of both processing and matrix effects on the detection of egg, milk, soy, and peanut allergens in foodstuffs. The main goals of this work were to identify difficulties that food laboratories still encounter in detecting and quantifying allergens and to sensitize researchers to them.

Bottom-up or top-down: unit cost estimation of tuberculosis diagnostic tests in India.

PubMed

Rupert, S; Vassall, A; Raizada, N; Khaparde, S D; Boehme, C; Salhotra, V S; Sachdeva, K S; Nair, S A; Hoog, A H Van't

2017-04-01

Of 18 sites that participated in an implementation study of the Xpert® MTB/RIF assay in India, we selected five microscopy centres and two reference laboratories. To obtain unit costs of diagnostic tests for tuberculosis (TB) and drug-resistant TB. Laboratories were purposely selected to capture regional variations and different laboratory types. Both bottom-up and the top-down methods were used to estimate unit costs. At the microscopy centres, mean bottom-up unit costs were respectively US$0.83 (range US$0.60-US$1.10) and US$12.29 (US$11.61-US$12.89) for sputum smear microscopy and Xpert. At the reference laboratories, mean unit costs were US$1.69 for the decontamination procedure, US$9.83 for a solid culture, US$11.06 for a liquid culture, US$29.88 for a drug susceptibility test, and US$18.18 for a line-probe assay. Top-down mean unit cost estimates were higher for all tests, and for sputum smear microscopy and Xpert these increased to respectively US$1.51 and US$13.58. The difference between bottom-up and top-down estimates was greatest for tests performed at the reference laboratories. These unit costs for TB diagnostics can be used to estimate resource requirements and cost-effectiveness in India, taking into account geographical location, laboratory type and capacity utilisation.

Correlation between microdilution, Etest, and disk diffusion methods for antifungal susceptibility testing of fluconazole against Candida sp. blood isolates.

PubMed

Menezes, Everardo Albuquerque; Vasconcelos Júnior, Antônio Alexandre de; Ângelo, Maria Rozzelê Ferreira; Cunha, Maria da Conceição dos Santos Oliveira; Cunha, Francisco Afrânio

2013-01-01

Antifungal susceptibility testing assists in finding the appropriate treatment for fungal infections, which are increasingly common. However, such testing is not very widespread. There are several existing methods, and the correlation between such methods was evaluated in this study. The susceptibility to fluconazole of 35 strains of Candida sp. isolated from blood cultures was evaluated by the following methods: microdilution, Etest, and disk diffusion. The correlation between the methods was around 90%. The disk diffusion test exhibited a good correlation and can be used in laboratory routines to detect strains of Candida sp. that are resistant to fluconazole.

Performance and Cost Efficiency of KRAS Mutation Testing for Metastatic Colorectal Cancer in Routine Diagnosis: The MOKAECM Study, a Nationwide Experience

PubMed Central

Chatellier, Gilles; Côté, Jean-François; Pages, Jean-Christophe; de Fraipont, Florence; Boyer, Jean-Christophe; Merlio, Jean Philippe; Morel, Alain; Gorisse, Marie-Claude; de Cremoux, Patricia; Leroy, Karen; Milano, Gérard; Ouafik, L’Houcine; Merlin, Jean-Louis; Le Corre, Delphine; Aucouturier, Pascaline; Sabourin, Jean-Christophe; Nowak, Frédérique; Frebourg, Thierry; Emile, Jean-François; Durand-Zaleski, Isabelle; Laurent-Puig, Pierre

2013-01-01

Purpose Rapid advances in the understanding of cancer biology have transformed drug development thus leading to the approval of targeted therapies and to the development of molecular tests to select patients that will respond to treatments. KRAS status has emerged as a negative predictor of clinical benefit from anti-EGFR antibodies in colorectal cancer, and anti-EGFR antibodies use was limited to KRAS wild type tumors. In order to ensure wide access to tumor molecular profiling, the French National Cancer Institute (INCa) has set up a national network of 28 regional molecular genetics centers. Concurrently, a nationwide external quality assessment for KRAS testing (MOKAECM) was granted to analyze reproducibility and costs. Methods 96 cell-line DNAs and 24 DNA samples from paraffin embedded tumor tissues were sent to 40 French laboratories. A total of 5448 KRAS results were collected and analyzed and a micro-costing study was performed on sites for 5 common methods by an independent team of health economists. Results This work provided a baseline picture of the accuracy and reliability of KRAS analysis in routine testing conditions at a nationwide level. Inter-laboratory Kappa values were >0.8 for KRAS results despite differences detection methods and the use of in-house technologies. Specificity was excellent with only one false positive in 1128 FFPE data, and sensitivity was higher for targeted techniques as compared to Sanger sequencing based methods that were dependent upon local expertise. Estimated reagent costs per patient ranged from €5.5 to €19.0. Conclusion The INCa has set-up a network of public laboratories dedicated to molecular oncology tests. Our results showed almost perfect agreements in KRAS testing at a nationwide level despite different testing methods ensuring a cost-effective equal access to personalized colorectal cancer treatment. PMID:23935912

A System Approach to Navy Medical Education and Training. Appendix 25. Competency Curricula for Clinical Laboratory Assistant and Medical Laboratory Technician.

DTIC Science & Technology

1974-08-31

morphology 10I I Platelet morphology Estimating platelet numbers Normal values Use of oil immersion microscope Use of differential cell tabulator i 1...by use of impregnated discs on the surface of media (Mueller Hinton) seeded with test organism, or by bacteria or serum tube dilution methods...result Physiologic incompatibilities of test results Use and operation of refractometer , urinometer and centrifuge microscope Recognition of

Comparison of RFFIT tests with different standard sera and testing procedures.

PubMed

Yu, Peng-cheng; Noguchi, Akira; Inoue, Satoshi; Tang, Qing; Rayner, Simon; Liang, Guo-dong

2012-06-01

The World Health Organization (WHO) standard assay for determining antibody level is the rapid fluorescent focus inhibition test (RFFIT) and is used to determine the degree of immunity after vaccination against rabies. To compare the difference in RFFIT results between the laboratories of The National Institute of Infectious Disease in Japan (NIID) and the Chinese Centre for Disease Control (CCDC) as well the influence of the choice of standard serum (STD) for the detection, the two laboratories detection methods were simultaneously manipulated by RFFIT. The reference serums used in NIID and the WHO standard serum used in CCDC were compared in the same RFFIT detection to determine the titer of four sera samples C1, S1, S2 and S4 in parallel, and the titers of the detected sera samples were calculated using the standard formula for neutralizing antibody titer. No significant difference was found in RFFIT methods from the two laboratories and the RFFIT testing procedures of the two laboratories have good consistency. However, different titers were obtained with the tentative internal standard serum (TI-STD) produced by adjusting to 2.0 IU of WHO standard serum in NIID and the WHO STD. The titer determined with the TI-STD was higher than that determined with WHO STD, This difference appears to be significant and requires further investigation.

Sensitivity, specificity, and reproducibility of four measures of laboratory turnaround time.

PubMed

Valenstein, P N; Emancipator, K

1989-04-01

The authors studied the performance of four measures of laboratory turnaround time: the mean, median, 90th percentile, and proportion of tests reported within a predetermined cut-off interval (proportion of acceptable tests [PAT]). Measures were examined with the use of turnaround time data from 11,070 stat partial thromboplastin times, 16,761 urine cultures, and 28,055 stat electrolyte panels performed by a single laboratory. For laboratories with long turnaround times, the most important quality of a turnaround time measure is high reproducibility, so that improvement in reporting speed can be distinguished from random variation resulting from sampling. The mean was found to be the most reproducible of the four measures, followed by the median. The mean achieved acceptable precision with sample sizes of 100-500 tests. For laboratories with normally rapid turnaround times, the most important quality of a measure is high sensitivity and specificity for detecting whether turnaround time has dropped below standards. The PAT was found to be the best measure of turnaround time in this setting but required sample sizes of at least 500 tests to achieve acceptable accuracy. Laboratory turnaround time may be measured for different reasons. The method of measurement should be chosen with an eye toward its intended application.

40 CFR 80.47 - Performance-based Analytical Test Method Approach.

Code of Federal Regulations, 2014 CFR

2014-07-01

... chemistry and statistics, or at least a bachelor's degree in chemical engineering, from an accredited... be compensated for any known chemical interferences using good laboratory practices. (3) The test... section, individual test results shall be compensated for any known chemical interferences using good...

Comparing the field and laboratory emission cell (FLEC) with traditional emissions testing chambers

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

Roache, N.F.; Guo, Z.; Fortmann, R.

1996-12-31

A series of tests was designed to evaluate the performance of the field and laboratory emission cell (FLEC) as applied to the testing of emissions from two indoor coating materials, floor wax and latex paint. These tests included validation of the repeatability of the test method, evaluation of the effect of different air velocities on source emissions, and a comparison of FLEC versus small chamber characterization of emissions. The FLEC exhibited good repeatability in characterization of emissions when applied to both sources under identical conditions. Tests with different air velocities showed significant effects on the emissions from latex paint, yetmore » little effect on emissions from the floor wax. Comparisons of data from the FLEC and small chamber show good correlation for measurements involving floor wax, but less favorable results for emissions from latex paint. The procedures and findings are discussed; conclusions are limited and include emphasis on the need for additional study and development of a standard method.« less

A Method for Evaluating the Efficacy of Antifouling Paints Using Mytilus galloprovincialis in the Laboratory in a Flow-Through System

PubMed Central

Satuito, Cyril Glenn Perez; Katsuyama, Ichiro; Ando, Hirotomo; Seki, Yasuyuki; Senda, Tetsuya

2016-01-01

A laboratory test with a flow-through system was designed and its applicability for testing antifouling paints of varying efficacies was investigated. Six different formulations of antifouling paints were prepared to have increasing contents (0 to 40 wt.%) of Cu2O, which is the most commonly used antifouling substance, and each formulation of paint was coated on just one surface of every test plate. The test plates were aged for 45 days by rotating them at a speed of 10 knots inside a cylinder drum. A behavioral test was then conducted using five mussels (Mytilus galloprovincialis) that were pasted onto the coated surface of each aged test plate. The number of the byssus threads produced by each mussel generally decreased with increasing Cu2O content of the paint. The newly designed method was considered valid owing to the high consistency of its results with observations from the field experiment. PMID:27959916

The Synthetic Experiment: E. B. Titchener's Cornell Psychological Laboratory and the Test of Introspective Analysis.

PubMed

Evans, Rand B

2017-01-01

Beginning in 1 9a0, a major thread of research was added to E. B. Titchener's Cornell laboratory: the synthetic experiment. Titchener and his graduate students used introspective analysis to reduce a perception, a complex experience, into its simple sensory constituents. To test the validity of that analysis, stimulus patterns were selected to reprodiuce the patterns of sensations found in the introspective analyses. If the original perception can be reconstructed in this way, then the analysis was considered validated. This article reviews development of the synthetic method in E. B. Titchener's laboratory at Cornell University and examines its impact on psychological research.

Requirements for diagnosis of malaria at different levels of the laboratory network in Africa.

PubMed

Long, Earl G

2009-06-01

The rapid increase of resistance to cheap, reliable antimalarials, the increasing cost of effective drugs, and the low specificity of clinical diagnosis has increased the need for more reliable diagnostic methods for malaria. The most commonly used and most reliable remains microscopic examination of stained blood smears, but this technique requires skilled personnel, precision instruments, and ideally a source of electricity. Microscopy has the advantage of enabling the examiner to identify the species, stage, and density of an infection. An alternative to microscopy is the rapid diagnostic test (RDT), which uses a labeled monoclonal antibody to detect circulating parasitic antigens. This test is most commonly used to detect Plasmodium falciparum infections and is available in a plastic cassette format. Both microscopy and RDTs should be available at all levels of laboratory service in endemic areas, but in peripheral laboratories with minimally trained staff, the RDT may be a more practical diagnostic method.

The standardization of urine particle counting in medical laboratories--a Polish experience with the EQA programme.

PubMed

Cwiklińska, Agnieszka; Kąkol, Judyta; Kuchta, Agnieszka; Kortas-Stempak, Barbara; Pacanis, Anastasis; Rogulski, Jerzy; Wróblewska, Małgorzata

2012-02-01

Given the common problems with the standardization of urine particle counting methods and the great variability in the results obtained by Polish laboratories under international Labquality External Quality Assessment (EQA), we initiated educational recovery activities. Detailed instructions on how to perform the standardized examination were sent to EQA participants, as was a questionnaire forms which enabled information to be gathered in respect to the procedures being applied. Laboratory results were grouped according to the method declared on the EQA 'Result' form or according to a manual examination procedure established on the basis of the questionnaire. The between-laboratory CVs for leukocyte and erythrocyte counts were calculated for each group and compared using the Mann-Whitney test. Significantly lower between-laboratory CVs (p = 0.03) were achieved for leukocyte counting among the laboratories that analysed control specimens in accordance with standardized procedures as compared with those which used non-standardized procedures. We also observed a visible lower variability for erythrocyte counting. Unfortunately despite our activities, only a few of the Polish laboratories applied the standardized examination procedures, and only 29% of the results could have been considered to be standardized (16% - manual methods, 13% - automated systems). The standardization of urine particle counting methods continues to be a significant problem in medical laboratories and requires further recovery activities which can be conducted using the EQA scheme.

The Italian external quality assessment for RAS testing in colorectal carcinoma identifies methods-related inter-laboratory differences.

PubMed

Normanno, Nicola; Pinto, Carmine; Castiglione, Francesca; Fenizia, Francesca; Barberis, Massimo; Marchetti, Antonio; Fontanini, Gabriella; De Rosa, Gaetano; Taddei, Gian Luigi

2015-09-03

In 2014 the European Medicines Agency included exon 2, 3 and 4 KRAS and NRAS testing for the selection of metastatic colorectal cancer (mCRC) patients eligible for the therapy with anti-EGFR monoclonal antibodies. The Italian Association of Medical Oncology (AIOM) and the Italian Society of Pathology and Cytology (SIAPEC) organized an external quality assessment (EQA) scheme for CRC to evaluate inter-laboratory consistency and to ensure standardization of the results in the transition from KRAS to all-RAS testing. Ten formalin fixed paraffin embedded specimens including KRAS/NRAS (exons 2, 3, 4) and BRAF (codon 600) mutations were validated by three referral laboratories and sent to 88 participant centers. Molecular pathology sample reports were also requested to each laboratory. A board of assessors from AIOM and SIAPEC evaluated the results according to a predefined scoring system. The scheme was composed of two rounds. In the first round 36% of the 88 participants failed, with 23 centers having at least one false positive or false negative while 9 centers did not meet the deadline. The genotyping error rate was higher when Sanger sequencing was employed for testing as compared with pyrosequencing (3 vs 1.3%; p = 0.01; Pearson Chi Square test). In the second round, the laboratories improved their performance, with 23/32 laboratories passing the round. Overall, 79/88 participants passed the RAS EQA scheme. Standardized Human Genome Variation Society nomenclature was incorrectly used to describe the mutations identified and relevant variations were noticed in the genotype specification. The results of the Italian RAS EQA scheme indicate that the mutational analyses are performed with good quality in many Italian centers, although significant differences in the methods used were highlighted. The relatively high number of centers failing the first round underlines the fundamental role in continued education covered by EQA schemes.

Task-shifting point-of-care CD4+ testing to lay health workers in HIV care and treatment services in Namibia.

PubMed

Kaindjee-Tjituka, Francina; Sawadogo, Souleymane; Mutandi, Graham; Maher, Andrew D; Salomo, Natanael; Mbapaha, Claudia; Neo, Marytha; Beukes, Anita; Gweshe, Justice; Muadinohamba, Alexinah; Lowrance, David W

2017-01-01

Access to CD4+ testing remains a common barrier to early initiation of antiretroviral therapy among persons living with HIV/AIDS in low- and middle-income countries. The feasibility of task-shifting of point-of-care (POC) CD4+ testing to lay health workers in Namibia has not been evaluated. From July to August 2011, Pima CD4+ analysers were used to improve access to CD4+ testing at 10 selected public health facilities in Namibia. POC Pima CD4+ testing was performed by nurses or lay health workers. Venous blood samples were collected from 10% of patients and sent to centralised laboratories for CD4+ testing with standard methods. Outcomes for POC Pima CD4+ testing and patient receipt of results were compared between nurses and lay health workers and between the POC method and standard laboratory CD4+ testing methods. Overall, 1429 patients received a Pima CD4+ test; 500 (35.0%) tests were performed by nurses and 929 (65.0%) were performed by lay health workers. When Pima CD4+ testing was performed by a nurse or a lay health worker, 93.2% and 95.2% of results were valid ( p = 0.1); 95.6% and 98.1% of results were received by the patient ( p = 0.007); 96.2% and 94.0% of results were received by the patient on the same day ( p = 0.08). Overall, 97.2% of Pima CD4+ results were received by patients, compared to 55.4% of standard laboratory CD4+ results ( p < 0.001). POC CD4+ testing was feasible and effective when task-shifted to lay health workers. Rollout of POC CD4+ testing via task-shifting can improve access to CD4+ testing and retention in care between HIV diagnosis and antiretroviral therapy initiation in low- and middle-income countries.

An investigation of the direct-drive method of susceptibility testing

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

Bonn, R.H.

1992-07-01

The Naval Surface Weapons Laboratory has constructed a small electrical subsystem for the purpose of evaluating electrical upset from various electromagnetic sources. The subsystem consists of three boxes, two of which are intended to be illuminated by electromagnetic waves. The two illuminated boxes are connected by two unshielded cable bundles. The goal of the Navy test series is to expose the subsystem to electromagnetic illumination from several different types of excitation, document upset levels, and compare the results. Before its arrival at Sandia National Laboratories (SNL) the system was illuminated in a mode stirred chamber and in an anechoic chamber.more » This effort was a continuation of that test program. The Sandia tests involved the test methodology referred to as bulk current injection (BCI). Because this is a poorly-shielded, multiple-aperture system, the method was not expected to compare closely to the other test methods. The test results show that. The BCI test methodology is a useful test technique for a subset of limited aperture systems; the methodology will produce incorrect answers when used improperly on complex systems; the methodology can produce accurate answers on simple systems with a well-controlled electromagnetic topology. This is a preliminary study and the results should be interpreted carefully.« less

Inter-laboratory exercise on antibiotic drugs analysis in aqueous samples.

PubMed

Roig, B; Brogat, M; Mompelat, S; Leveque, J; Cadiere, A; Thomas, O

2012-08-30

An inter-laboratory exercise was organized under the PHARMAS EU project, by the Advanced School of Public Health (EHESP), in order to evaluate the performances of analytical methods for the measurement of antibiotics in waters (surface and tap). This is the first time such an exercise on antibiotics has been organized in Europe, using different kinds of analytical methods and devices. In this exercise thirteen laboratories from five countries (Canada, France, Italy, the Netherlands and Portugal) participated, and a total number of 78 samples were distributed. During the exercise, 2 testing samples (3 bottles of each) prepared from tap water and river water, respectively, spiked with antibiotics, were sent to participants and analyzed over a period of one month. A final number of 77 (98.7%) testing samples were considered. Depending on substances studied by each participant, 305 values in duplicate were collected, with the results for each sample being expressed as the target concentration. A statistical study was initiated using 611 results. The mean value, standard deviation, coefficient of variation, standard uncertainty of the mean, median, the minimum and maximum values of each series as well as the 95% confidence interval were obtained from each participant laboratory. In this exercise, 36 results (6% of accounted values) were outliers according to the distribution over the median (box plot). The outlier results were excluded. In order to establish the stability of testing samples in the course of the exercise, differences between variances obtained for every type of sample at different intervals were evaluated. The results showed no representative variations and it can be considered that all samples were stable during the exercise. The goals of this inter-laboratory study were to assess results variability when analysis is conducted by different laboratories, to evaluate the influence of different matrix samples, and to determine the rate at which participating laboratories successfully completed the tests initiated. Copyright © 2012 Elsevier B.V. All rights reserved.

Drop Testing Representative Multi-Canister Overpacks

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

Snow, Spencer D.; Morton, Dana K.

The objective of the work reported herein was to determine the ability of the Multi- Canister Overpack (MCO) canister design to maintain its containment boundary after an accidental drop event. Two test MCO canisters were assembled at Hanford, prepared for testing at the Idaho National Engineering and Environmental Laboratory (INEEL), drop tested at Sandia National Laboratories, and evaluated back at the INEEL. In addition to the actual testing efforts, finite element plastic analysis techniques were used to make both pre-test and post-test predictions of the test MCOs structural deformations. The completed effort has demonstrated that the canister design is capablemore » of maintaining a 50 psig pressure boundary after drop testing. Based on helium leak testing methods, one test MCO was determined to have a leakage rate not greater than 1x10 -5 std cc/sec (prior internal helium presence prevented a more rigorous test) and the remaining test MCO had a measured leakage rate less than 1x10 -7 std cc/sec (i.e., a leaktight containment) after the drop test. The effort has also demonstrated the capability of finite element methods using plastic analysis techniques to accurately predict the structural deformations of canisters subjected to an accidental drop event.« less

Laboratory diagnosis of Ebola virus disease and corresponding biosafety considerations in the China Ebola Treatment Center.

PubMed

Huang, Qing; Fu, Wei-Ling; You, Jian-Ping; Mao, Qing

2016-10-01

Ebola virus disease (EVD), caused by Ebola virus (EBOV), is a potent acute infectious disease with a high case-fatality rate. Etiological and serological EBOV detection methods, including techniques that involve the detection of the viral genome, virus-specific antigens and anti-virus antibodies, are standard laboratory diagnostic tests that facilitate confirmation or exclusion of EBOV infection. In addition, routine blood tests, liver and kidney function tests, electrolytes and coagulation tests and other diagnostic examinations are important for the clinical diagnosis and treatment of EVD. Because of the viral load in body fluids and secretions from EVD patients, all body fluids are highly contagious. As a result, biosafety control measures during the collection, transport and testing of clinical specimens obtained from individuals scheduled to undergo EBOV infection testing (including suspected, probable and confirmed cases) are crucial. This report has been generated following extensive work experience in the China Ebola Treatment Center (ETC) in Liberia and incorporates important information pertaining to relevant diagnostic standards, clinical significance, operational procedures, safety controls and other issues related to laboratory testing of EVD. Relevant opinions and suggestions are presented in this report to provide contextual awareness associated with the development of standards and/or guidelines related to EVD laboratory testing.

Wireless vibration monitoring for damage detection of highway bridges

NASA Astrophysics Data System (ADS)

Whelan, Matthew J.; Gangone, Michael V.; Janoyan, Kerop D.; Jha, Ratneshwar

2008-03-01

The development of low-cost wireless sensor networks has resulted in resurgence in the development of ambient vibration monitoring methods to assess the in-service condition of highway bridges. However, a reliable approach towards assessing the health of an in-service bridge and identifying and localizing damage without a priori knowledge of the vibration response history has yet to be formulated. A two-part study is in progress to evaluate and develop existing and proposed damage detection schemes. The first phase utilizes a laboratory bridge model to investigate the vibration response characteristics induced through introduction of changes to structural members, connections, and support conditions. A second phase of the study will validate the damage detection methods developed from the laboratory testing with progressive damage testing of an in-service highway bridge scheduled for replacement. The laboratory bridge features a four meter span, one meter wide, steel frame with a steel and cement board deck composed of sheet layers to regulate mass loading and simulate deck wear. Bolted connections and elastomeric bearings provide a means for prescribing variable local stiffness and damping effects to the laboratory model. A wireless sensor network consisting of fifty-six accelerometers accommodated by twenty-eight local nodes facilitates simultaneous, real-time and high-rate acquisition of the vibrations throughout the bridge structure. Measurement redundancy is provided by an array of wired linear displacement sensors as well as a scanning laser vibrometer. This paper presents the laboratory model and damage scenarios, a brief description of the developed wireless sensor network platform, an overview of available test and measurement instrumentation within the laboratory, and baseline measurements of dynamic response of the laboratory bridge model.

Improvement of coagulation laboratory practice in Thailand: the first-year experience of the national external quality assessment scheme for blood coagulation.

PubMed

Tientadakul, Panutsaya; Opartkiattikul, Nisarat; Wongtiraporn, Wanida

2009-01-01

In Thailand until 2005 there had been no external quality assessment scheme at the national level for blood coagulation tests. Only a few laboratories had an external quality assessment for these tests. In the year 2005, the Thailand National External Quality Assessment Scheme for Blood Coagulation was founded. To describe the establishment of the Thailand National External Quality Assessment Scheme for Blood Coagulation (including problems encountered and solutions), its progression and expansion, and the improvement of coagulation laboratory practice in Thailand during 2 trial surveys and 4 formal surveys conducted in the first 1 1/2 years. Between 2005 and 2006, the external quality assessment samples for prothrombin time/international normalized ratio and activated partial thromboplastin time were distributed to the participants as well as the instructions and suggestions for the improvement of laboratory practice. From the data collected, the all-method coefficient of variation of the international normalized ratio and activated partial thromboplastin time was calculated for each survey. The number of participants increased during the first 1 1/2 years that the surveys were conducted, from 109 to 127. Survey data demonstrate an improvement in response rate and an increase in the number of laboratories that determine their own reference ranges and repeat this for every change of reagent lot, using the appropriate anticoagulant. The increased precision of tests is indicated by the decrease of the all-method coefficient of variation of the international normalized ratio and activated partial thromboplastin time. Examples of individual laboratory improvement through feedback are also described. The improvement of coagulation laboratory practice both through the instructions provided and liaison with participants was observed during the course of this scheme.

Department of Homeland Security (DHS) Proficiency Testing on Small-Scale Safety and Thermal Testing of Improvised Explosives

NASA Astrophysics Data System (ADS)

Reynolds, John; Sandstrom, Mary; Brown, Geoffrey; Warner, Kirstin; Phillips, Jason; Shelley, Timothy; Reyes, Jose; Hsu, Peter

2013-06-01

One of the first steps in establishing safe handling procedures for explosives is small-scale safety and thermal (SSST) testing. To better understand the response of improvised materials or HMEs to SSST testing, 18 HME materials were compared to 3 standard military explosives in a proficiency-type round robin study among five laboratories--2 DoD and 3 DOE--sponsored by DHS. The testing matrix has been designed to address problems encountered with improvised materials--powder mixtures, liquid suspensions, partially wetted solids, immiscible liquids, and reactive materials. Over 30 issues have been identified that indicate standard test methods may require modification when applied to HMEs to derive accurate sensitivity assessments needed for development safe handling and storage practices. This presentation will discuss experimental difficulties encountered when testing these problematic samples, show inter-laboratory testing results, show some statistical interpretation of the results, and highlight some of the testing issues. Some of the work was performed under the auspices of the U.S. Department of Energy by Lawrence Livermore National Laboratory under Contract DE-AC52-07NA27344. LLNL-ABS-617519 (721812).

Biomagnetic Pair Therapy and Typhoid Fever: A Pilot Study.

PubMed

Frank, Bryan L

2017-10-01

Objective: This pilot study examined the laboratory responses of patients with laboratory-documented typhoid fever who were treated with Biomagnetic Pair Therapy (BPT; medical biomagnetism), a specific application of pairs of magnets for various ailments that are infectious and otherwise. Materials and Methods: This study was an assessment of patients' response to treatment with only BPT for Salmonella typhi infections (typhoid fever) using standard conventional laboratory techniques. The research was conducted in an outpatient village clinic in Kenya. There were 52 participants who were evaluated for possible systemic illness, including typhoid fever, from an open-label study. Participants who felt sick and requested testing for possible typhoid fever were tested with a standard Widal test by a certified laboratory technician. Participants who tested positive (13 patients) were then treated with BPT (a "First Aid" approach) only. These participants then returned for follow-up laboratory and clinical evaluations after 2 days. Results: Most of the participants (10 of 13) retested as negative, and all patients reported symptomatic clinical improvement. Conclusions: As a significant majority of participants demonstrated clearing of their S. typhi after BPT, this technique should be studied further in larger trials for its efficacy in treating typhoid fever.

Restructuring of international council for standardization in haematology (ICSH) in Asia.

PubMed

Tatsumi, N; Lewis, S M

2002-08-01

Standardization and harmonization in Laboratory testing are a key issue in the midst of globalization era, because most of laboratory testing has been currently achieved with various kinds of automated systems. In the developed countries, automated systems with highly-regulated principles are commonly used in the routine laboratory. However, there are so many undeveloped and developing countries in Asia that diversity of testing levels can be observed in the area. Some laboratories use glass chamber method for blood cell counting, while other laboratory use semi-automated or fully automated analyzers for complete blood count. International standardization on Hematology is focused on the developed system but not for the developing system. Established standardized documents therefore whould not be unsuitable for Asian societies. In the context, International Council for Standardization in Hematology (ICSH) changed its rules to adjust our Asian Societies and ICSH started to restructure the body. International ICSH society is divided into 5 region sub-groups. Asian area is able to possess one new sub-society, ICSH-Asia. Its reconstruction work has been just started with Asain colleagues, and we are now extending the new societies to discuss Asian problems on the quality of hematology testing.

European Proficiency testing of national reference laboratories for the confirmation of sulfonamide residues in muscle and milk.

PubMed

Juhel-Gaugain, Murielle; Fourmond, Marie-Pierre; Delepine, Bernard; Laurentie, Michel; Brigitte, Roudaut; Sanders, Pascal

2005-03-01

Two interlaboratory studies were organized in 2002-2003 in order to check the proficiency of laboratories in confirming the presence of sulfonamide residues in muscle and milk. These studies involved 25 EU National Reference Laboratories (NRLs) from 21 different European Countries in charge of statutory monitoring of antimicrobial residues in food of animal origin at a national level. The study was conducted according to international and national guidelines by the Community Reference Laboratory (CRL) in charge of antimicrobial substances. Four different test matrices of sheep muscle and four different test matrices of bovine milk containing different sulfonamide substances were prepared and sent to the participants. Each participant was asked to use his own routine confirmatory method and to analyse each sample in triplicate within a period of about six weeks during which the stability of the materials was checked by the organizer. The sulfonamide content of each material was determined by calculating the robust means of all the results and the deviation of the results from the assigned values was assessed by calculating Z-scores. Overall, results were satisfactory, particularly considering that it was the first proficiency test dealing with sulfonamides organised by the Community Reference Laboratory.

Utilization of Genetic Testing Prior to Subspecialist Referral for Cerebellar Ataxia

PubMed Central

Fogel, Brent L.; Vickrey, Barbara G.; Walton-Wetzel, Jenny; Lieber, Eli

2013-01-01

Objective: To evaluate the utilization of laboratory testing in the diagnosis of cerebellar ataxia, including the completeness of initial standard testing for acquired causes, the early use of genetic testing, and associated clinical and nonclinical factors, among a cohort referred for subspecialty consultation. Methods: Data were abstracted from records of 95 consecutive ataxia patients referred to one neurogenetics subspecialist from 2006–2010 and linked to publicly available data on characteristics of referral clinicians. Multivariable logistic and linear regression models were used to analyze unique associations of clinical and nonclinical factors with laboratory investigation of acquired causes and with early genetic testing prior to referral. Results: At referral, 27 of 95 patients lacked evidence of any of 14 laboratory studies suggested for initial work-up of an acquired cause for ataxia (average number of tests=4.5). In contrast, 92% of patients had undergone brain magnetic resonance imaging prior to referral. Overall, 41.1% (n=39) had genetic testing prior to referral; there was no association between family history of ataxia and obtaining genetic testing prior to referral (p=0.39). The level of early genetic testing was 31.6%, primarily due to genetic testing despite an incomplete laboratory evaluation for acquired causes and no family history. A positive family history was consistently associated with less extensive laboratory testing (p=0.004), and referral by a neurologist was associated with higher levels of early genetic testing. Conclusions: Among consecutive referrals to a single center, a substantial proportion of sporadic cases had genetic testing without evidence of a work-up for acquired causes. Better strategies to guide decision making and subspecialty referrals in rare neurologic disorders are needed, given the cost and consequences of genetic testing. PMID:23725007

C-B3-03: Development and Pilot Testing of Guidelines to Monitor High-Risk Medications in the Ambulatory Setting

PubMed Central

Tjia, Jennifer; Field, Terry; Garber, Lawrence; Raebel, Marsha; Donovan, Jennifer; Kanaan, Abir; Fischer, Shira; Gagne, Shawn; Zhao, Yanfang; Fuller, Jackie; Gurwitz, Jerry

2010-01-01

Background: Inadequate laboratory monitoring of high-risk medications contributes to preventable adverse drug events. One barrier to appropriate monitoring is lack of standardized monitoring guidelines. The study aims were to develop guidelines to monitor high-risk medications and to assess the prevalence of laboratory testing for these medications in a multispecialty group practice. Methods: We developed guidelines for laboratory monitoring of high-risk medications as part of a patient safety intervention trial. An advisory committee of national experts and local leaders (clinicians, pharmacists, pharmacoepidemiologists, and patient safety experts) used a two-round, internet-based Delphi process to select guideline medications based on the importance of monitoring for efficacy, safety, and drug-drug interactions. Test frequency recommendations were developed by academic pharmacists based on literature review and local interdisciplinary consensus. To estimate the potential impact of the intervention, we determined the prevalence of high-risk drug dispensings and laboratory testing for guideline medications between January 1, 2008 and July 31, 2008. Results: Consensus on medications to include in the guidelines was achieved in two rounds. Final guidelines included 35 drugs/drug classes and 61 laboratory tests. The prevalence of monitoring ranged from <50% to >90%, with infrequently prescribed drugs having a lower prevalence of recommended testing. When more than one test was recommended for a selected medication, monitoring within a medication sometimes differed by > 50%. Conclusions: Even among drugs where there is general consensus that laboratory monitoring is important, prevalence of monitoring is highly variable. Further, infrequently prescribed medications are at higher risk for poor monitoring.

Research on the Error Characteristics of a 110 kV Optical Voltage Transformer under Three Conditions: In the Laboratory, Off-Line in the Field and During On-Line Operation

PubMed Central

Xiao, Xia; Hu, Haoliang; Xu, Yan; Lei, Min; Xiong, Qianzhu

2016-01-01

Optical voltage transformers (OVTs) have been applied in power systems. When performing accuracy performance tests of OVTs large differences exist between the electromagnetic environment and the temperature variation in the laboratory and on-site. Therefore, OVTs may display different error characteristics under different conditions. In this paper, OVT prototypes with typical structures were selected to be tested for the error characteristics with the same testing equipment and testing method. The basic accuracy, the additional error caused by temperature and the adjacent phase in the laboratory, the accuracy in the field off-line, and the real-time monitoring error during on-line operation were tested. The error characteristics under the three conditions—laboratory, in the field off-line and during on-site operation—were compared and analyzed. The results showed that the effect of the transportation process, electromagnetic environment and the adjacent phase on the accuracy of OVTs could be ignored for level 0.2, but the error characteristics of OVTs are dependent on the environmental temperature and are sensitive to the temperature gradient. The temperature characteristics during on-line operation were significantly superior to those observed in the laboratory. PMID:27537895

Research on the Error Characteristics of a 110 kV Optical Voltage Transformer under Three Conditions: In the Laboratory, Off-Line in the Field and During On-Line Operation.

PubMed

Xiao, Xia; Hu, Haoliang; Xu, Yan; Lei, Min; Xiong, Qianzhu

2016-08-16

Optical voltage transformers (OVTs) have been applied in power systems. When performing accuracy performance tests of OVTs large differences exist between the electromagnetic environment and the temperature variation in the laboratory and on-site. Therefore, OVTs may display different error characteristics under different conditions. In this paper, OVT prototypes with typical structures were selected to be tested for the error characteristics with the same testing equipment and testing method. The basic accuracy, the additional error caused by temperature and the adjacent phase in the laboratory, the accuracy in the field off-line, and the real-time monitoring error during on-line operation were tested. The error characteristics under the three conditions-laboratory, in the field off-line and during on-site operation-were compared and analyzed. The results showed that the effect of the transportation process, electromagnetic environment and the adjacent phase on the accuracy of OVTs could be ignored for level 0.2, but the error characteristics of OVTs are dependent on the environmental temperature and are sensitive to the temperature gradient. The temperature characteristics during on-line operation were significantly superior to those observed in the laboratory.

Indications for laboratory tests in primary care: assessment of the most frequent indications and requests with blank clinical information

PubMed Central

Salinas, Maria; López-Garrigós, Maite; Flores, Emilio; Leiva-Salinas, Maria; Esteban, Patricia; Ahumada, Miguel; Leiva-Salinas, Carlos

2016-01-01

Introduction The aim of this work is twofold. Firstly, to study the temporal evolution in the number of laboratory requests from primary care without clinical indication, and to analyse the number of such requests before and after the implementation of an automated requesting procedure. Secondly, to investigate what are the most frequent clinical indications that prompted laboratory testing. Materials and methods This is a retrospective observational study conducted from January 2009 to December 2015. We counted the requests without clinical question, calculated the number of such requests per total number of requests and listed the most frequent indications. Results The number of tests requests with a blank clinical indication was significantly higher in 2009 when compared to 2015 (80% vs. 20%; P < 0.001). For every year in this 7-year period, dyslipidemia, essential hypertension and diabetes were the most prevalent diagnoses that prompted a laboratory test in primary care, accounting for more than 20% of all indications. Conclusions The number of primary care requests without patient clinical question has decreased after the implementation of an automated requesting procedure. Disorders of lipid metabolism, essential hypertension and diabetes mellitus were the most prevalent diagnoses that prompted a laboratory test in primary care. PMID:27812310

Interlaboratory evaluation of a standardized inductively coupled plasma mass spectrometry method for the determination of trace beryllium in air filter samples.

PubMed

Ashley, Kevin; Brisson, Michael J; Howe, Alan M; Bartley, David L

2009-12-01

A collaborative interlaboratory evaluation of a newly standardized inductively coupled plasma mass spectrometry (ICP-MS) method for determining trace beryllium in workplace air samples was carried out toward fulfillment of method validation requirements for ASTM International voluntary consensus standard test methods. The interlaboratory study (ILS) was performed in accordance with an applicable ASTM International standard practice, ASTM E691, which describes statistical procedures for investigating interlaboratory precision. Uncertainty was also estimated in accordance with ASTM D7440, which applies the International Organization for Standardization Guide to the Expression of Uncertainty in Measurement to air quality measurements. Performance evaluation materials (PEMs) used consisted of 37 mm diameter mixed cellulose ester filters that were spiked with beryllium at levels of 0.025 (low loading), 0.5 (medium loading), and 10 (high loading) microg Be/filter; these spiked filters were prepared by a contract laboratory. Participating laboratories were recruited from a pool of over 50 invitees; ultimately, 20 laboratories from Europe, North America, and Asia submitted ILS results. Triplicates of each PEM (blanks plus the three different loading levels) were conveyed to each volunteer laboratory, along with a copy of the draft standard test method that each participant was asked to follow; spiking levels were unknown to the participants. The laboratories were requested to prepare the PEMs by one of three sample preparation procedures (hotplate or microwave digestion or hotblock extraction) that were described in the draft standard. Participants were then asked to analyze aliquots of the prepared samples by ICP-MS and to report their data in units of mu g Be/filter sample. Interlaboratory precision estimates from participating laboratories, computed in accordance with ASTM E691, were 0.165, 0.108, and 0.151 (relative standard deviation) for the PEMs spiked at 0.025, 0.5, and 10 microg Be/filter, respectively. Overall recoveries were 93.2%, 102%, and 80.6% for the low, medium, and high beryllium loadings, respectively. Expanded uncertainty estimates for interlaboratory analysis of low, medium, and high beryllium loadings, calculated in accordance with ASTM D7440, were 18.8%, 19.8%, and 24.4%, respectively. These figures of merit support promulgation of the analytical procedure as an ASTM International standard test method, ASTM D7439.

Moving Force Identification: a Time Domain Method

NASA Astrophysics Data System (ADS)

Law, S. S.; Chan, T. H. T.; Zeng, Q. H.

1997-03-01

The solution for the vertical dynamic interaction forces between a moving vehicle and the bridge deck is analytically derived and experimentally verified. The deck is modelled as a simply supported beam with viscous damping, and the vehicle/bridge interaction force is modelled as one-point or two-point loads with fixed axle spacing, moving at constant speed. The method is based on modal superposition and is developed to identify the forces in the time domain. Both cases of one-point and two-point forces moving on a simply supported beam are simulated. Results of laboratory tests on the identification of the vehicle/bridge interaction forces are presented. Computation simulations and laboratory tests show that the method is effective, and acceptable results can be obtained by combining the use of bending moment and acceleration measurements.

[Method validation according to ISO 15189 and SH GTA 04: application for the detection of KRAS mutations using PCR TaqMan assay].

PubMed

Harlé, Alexandre; Dubois, Cindy; Rouyer, Marie; Merlin, Jean-Louis

2013-01-01

Since January 16(th) 2010, the French legislation requires that the medical laboratories must be accredited according to ISO 15189 standards. Thus, all medical laboratories in France must be accredited for at least part of their biological tests before the end of October 2013. Molecular biology tests are also concerned by the accreditation. Validation of molecular biology methods is made difficult, for reasons related to the methods, but also by the type of analytes that are basically rare. This article describes the validation of the qualitative detection of KRAS mutations in metastatic colorectal cancer using TaqMan PCR according to ISO 15189 and to the technical guide for accreditation in Human Health, SH-GTA-04, edited by the COFRAC.

Laboratory diagnostics of malaria

NASA Astrophysics Data System (ADS)

Siahaan, L.

2018-03-01

Even now, malaria treatment should only be administered after laboratory confirmation. There are several principal methods for diagnosing malaria. All these methods have their disadvantages.Presumptive treatment of malaria is widely practiced where laboratory tests are not readily available. Microscopy of Giemsa-stained thick and thin blood films remains the gold standard for the diagnosis of malaria infection. The technique of slide preparation, staining and reading are well known and standardized, and so is the estimate of the parasite density and parasite stages. Microscopy is not always available or feasible at primary health services in limited resource settings due to cost, lack of skilled manpower, accessories and reagents required. Rapid diagnostic tests (RDTs) are potential tools for parasite-based diagnosis since the tests are accurate in detecting malaria infections and are easy to use. The test is based on the capture of parasite antigen that released from parasitized red blood cells using monoclonal antibodies prepared against malaria antigen target. Polymerase Chain Reaction (PCR), depend on DNA amplification approaches and have higher sensitivity than microscopy. PCR it is not widely used due to the lack of a standardized methodology, high costs, and the need for highly-trained staff.

What food and feeding rates are optimum for the Chironomus dilutus sediment toxicity test method?

EPA Science Inventory

Laboratory tests with benthic macroinvertebrates conducted using standard toxicity test procedures are used to assess the potential toxicity of contaminated sediments. Results are compared across sites or for batches of samples, and the performance of organisms in control treatme...

Low-Cost Method for Quantifying Sodium in Coconut Water and Seawater for the Undergraduate Analytical Chemistry Laboratory: Flame Test, a Mobile Phone Camera, and Image Processing

ERIC Educational Resources Information Center

Moraes, Edgar P.; da Silva, Nilbert S. A.; de Morais, Camilo de L. M.; das Neves, Luiz S.; de Lima, Kassio M. G.

2014-01-01

The flame test is a classical analytical method that is often used to teach students how to identify specific metals. However, some universities in developing countries have difficulties acquiring the sophisticated instrumentation needed to demonstrate how to identify and quantify metals. In this context, a method was developed based on the flame…

Comparison of High-Speed Operating Characteristics of Size 215 Cylindrical-Roller Bearings as Determined in Turbojet Engine and in Laboratory Test Rig

NASA Technical Reports Server (NTRS)

Macks, E Fred; Nemeth, Zolton N

1952-01-01

A comparison of the operating characteristics of 75-millimeter-bore (size 215) cylindrical-roller one-piece inner-race-riding cage-type bearings was made by means of a laboratory test rig and a turbojet engine. Cooling correlation parameters were determined by means of dimensional analysis, and the generalized results for both the inner- and the outer-race bearing operating temperatures are computed for the laboratory test rig and the turbojet engine. A method is given that enables the designer to predict the inner- and outer-race turbine roller-bearing temperatures from single curves, regardless of variations in speed, load, oil flow, oil inlet temperature, oil inlet viscosity, oil-jet diameter, or any combination of these parameters.

An easy, rapid and inexpensive method to monitor tributyltin (TBT) toxicity in the laboratory.

PubMed

Cruz, Andreia; Moreira, Rafael; Mendo, Sónia

2014-05-01

Tributyltin (TBT) contamination remains a major problem worldwide. Many laboratories are committed to the development of remediation methodologies that could help reduce the negative impact of this compound in the environment. Furthermore, it is important to have at hand simple methodologies for evaluating TBT toxicity in the laboratory, besides the use of complex and costly analytical instrumentation. With that purpose, a method was adapted that is based on the inhibition of growth of an indicator strain, Micrococcus luteus ATCC 9341, under TBT. Different types of matrices, of TBT concentrations and sample treatments were tested. The results herein reported show that the bioassay method can be applied for both aqueous and soil samples and also for a high range of TBT concentrations (at least up to 500 μmol/L). Besides being cheap and easy to perform, it can be performed in any laboratory. Additionally, one possible application of the method to monitor TBT degradation is presented as an example.

Prediction of Frequency for Simulation of Asphalt Mix Fatigue Tests Using MARS and ANN

PubMed Central

Fakhri, Mansour

2014-01-01

Fatigue life of asphalt mixes in laboratory tests is commonly determined by applying a sinusoidal or haversine waveform with specific frequency. The pavement structure and loading conditions affect the shape and the frequency of tensile response pulses at the bottom of asphalt layer. This paper introduces two methods for predicting the loading frequency in laboratory asphalt fatigue tests for better simulation of field conditions. Five thousand (5000) four-layered pavement sections were analyzed and stress and strain response pulses in both longitudinal and transverse directions was determined. After fitting the haversine function to the response pulses by the concept of equal-energy pulse, the effective length of the response pulses were determined. Two methods including Multivariate Adaptive Regression Splines (MARS) and Artificial Neural Network (ANN) methods were then employed to predict the effective length (i.e., frequency) of tensile stress and strain pulses in longitudinal and transverse directions based on haversine waveform. It is indicated that, under controlled stress and strain modes, both methods (MARS and ANN) are capable of predicting the frequency of loading in HMA fatigue tests with very good accuracy. The accuracy of ANN method is, however, more than MARS method. It is furthermore shown that the results of the present study can be generalized to sinusoidal waveform by a simple equation. PMID:24688400

Prediction of frequency for simulation of asphalt mix fatigue tests using MARS and ANN.

PubMed

Ghanizadeh, Ali Reza; Fakhri, Mansour

2014-01-01

Fatigue life of asphalt mixes in laboratory tests is commonly determined by applying a sinusoidal or haversine waveform with specific frequency. The pavement structure and loading conditions affect the shape and the frequency of tensile response pulses at the bottom of asphalt layer. This paper introduces two methods for predicting the loading frequency in laboratory asphalt fatigue tests for better simulation of field conditions. Five thousand (5000) four-layered pavement sections were analyzed and stress and strain response pulses in both longitudinal and transverse directions was determined. After fitting the haversine function to the response pulses by the concept of equal-energy pulse, the effective length of the response pulses were determined. Two methods including Multivariate Adaptive Regression Splines (MARS) and Artificial Neural Network (ANN) methods were then employed to predict the effective length (i.e., frequency) of tensile stress and strain pulses in longitudinal and transverse directions based on haversine waveform. It is indicated that, under controlled stress and strain modes, both methods (MARS and ANN) are capable of predicting the frequency of loading in HMA fatigue tests with very good accuracy. The accuracy of ANN method is, however, more than MARS method. It is furthermore shown that the results of the present study can be generalized to sinusoidal waveform by a simple equation.

[Fundamentals of quality control systems in medical-biochemical laboratories--the role of marketing].

PubMed

Topić, E; Turek, S

2000-01-01

The basic criterion for the overall quality system in medical biochemistry laboratories concerning equipment, premises and laboratory staff in primary health care (PHC) (Regulations on quality systems and good laboratory practice of the Croatian Medical Biochemists Chamber, 1995, Regulations on categorization of medical biochemistry laboratories of the Croatian Medical Biochemists Chamber, 1996, EC4: Essential criteria for quality systems in medical laboratories. Eur J Clin Chem Clin Biochem 1997 in medical biochemical laboratories included in the First Croatia health project, Primary health care subproject, has been met by the marketing approach to the project. The equipment ensuring implementation of the complete laboratory program (NN/96), more accurate and precise analytical procedures, and higher reliability of laboratory test results compared with previous equipment, has been purchased by an international tender. Uniform technology and methods of analysis have ensured high standards of good laboratory services, yielding test results than can be transferred from primary to secondary health care level. The new equipment has improved organization between central and detached medical biochemistry laboratory units, while the high quality requirement has led to improvement in the staff structure, e.g., medical biochemists have been employed in laboratories that had previously worked without such a professional. Equipment renewal has been accompanied by proper education for all levels of PHC professionals.

Segmentation-less Digital Rock Physics

NASA Astrophysics Data System (ADS)

Tisato, N.; Ikeda, K.; Goldfarb, E. J.; Spikes, K. T.

2017-12-01

In the last decade, Digital Rock Physics (DRP) has become an avenue to investigate physical and mechanical properties of geomaterials. DRP offers the advantage of simulating laboratory experiments on numerical samples that are obtained from analytical methods. Potentially, DRP could allow sparing part of the time and resources that are allocated to perform complicated laboratory tests. Like classic laboratory tests, the goal of DRP is to estimate accurately physical properties of rocks like hydraulic permeability or elastic moduli. Nevertheless, the physical properties of samples imaged using micro-computed tomography (μCT) are estimated through segmentation of the μCT dataset. Segmentation proves to be a challenging and arbitrary procedure that typically leads to inaccurate estimates of physical properties. Here we present a novel technique to extract physical properties from a μCT dataset without the use of segmentation. We show examples in which we use segmentation-less method to simulate elastic wave propagation and pressure wave diffusion to estimate elastic properties and permeability, respectively. The proposed method takes advantage of effective medium theories and uses the density and the porosity that are measured in the laboratory to constrain the results. We discuss the results and highlight that segmentation-less DRP is more accurate than segmentation based DRP approaches and theoretical modeling for the studied rock. In conclusion, the segmentation-less approach here presented seems to be a promising method to improve accuracy and to ease the overall workflow of DRP.

Validation of a Rapid Rabies Diagnostic Tool for Field Surveillance in Developing Countries

PubMed Central

Léchenne, Monique; Naïssengar, Kemdongarti; Lepelletier, Anthony; Alfaroukh, Idriss Oumar; Bourhy, Hervé; Zinsstag, Jakob; Dacheux, Laurent

2016-01-01

Background One root cause of the neglect of rabies is the lack of adequate diagnostic tests in the context of low income countries. A rapid, performance friendly and low cost method to detect rabies virus (RABV) in brain samples will contribute positively to surveillance and consequently to accurate data reporting, which is presently missing in the majority of rabies endemic countries. Methodology/Principal findings We evaluated a rapid immunodiagnostic test (RIDT) in comparison with the standard fluorescent antibody test (FAT) and confirmed the detection of the viral RNA by real time reverse transcription polymerase chain reaction (RT-qPCR). Our analysis is a multicentre approach to validate the performance of the RIDT in both a field laboratory (N’Djamena, Chad) and an international reference laboratory (Institut Pasteur, Paris, France). In the field laboratory, 48 samples from dogs were tested and in the reference laboratory setting, a total of 73 samples was tested, representing a wide diversity of RABV in terms of animal species tested (13 different species), geographical origin of isolates with special emphasis on Africa, and different phylogenetic clades. Under reference laboratory conditions, specificity was 93.3% and sensitivity was 95.3% compared to the gold standard FAT test. Under field laboratory conditions, the RIDT yielded a higher reliability than the FAT test particularly on fresh and decomposed samples. Viral RNA was later extracted directly from the test filter paper and further used successfully for sequencing and genotyping. Conclusion/Significance The RIDT shows excellent performance qualities both in regard to user friendliness and reliability of the result. In addition, the test cassettes can be used as a vehicle to ship viral RNA to reference laboratories for further laboratory confirmation of the diagnosis and for epidemiological investigations using nucleotide sequencing. The potential for satisfactory use in remote locations is therefore very high to improve the global knowledge of rabies epidemiology. However, we suggest some changes to the protocol, as well as careful further validation, before promotion and wider use. PMID:27706156

Inter-laboratory analysis of selected genetically modified plant reference materials with digital PCR.

PubMed

Dobnik, David; Demšar, Tina; Huber, Ingrid; Gerdes, Lars; Broeders, Sylvia; Roosens, Nancy; Debode, Frederic; Berben, Gilbert; Žel, Jana

2018-01-01

Digital PCR (dPCR), as a new technology in the field of genetically modified (GM) organism (GMO) testing, enables determination of absolute target copy numbers. The purpose of our study was to test the transferability of methods designed for quantitative PCR (qPCR) to dPCR and to carry out an inter-laboratory comparison of the performance of two different dPCR platforms when determining the absolute GM copy numbers and GM copy number ratio in reference materials certified for GM content in mass fraction. Overall results in terms of measured GM% were within acceptable variation limits for both tested dPCR systems. However, the determined absolute copy numbers for individual genes or events showed higher variability between laboratories in one third of the cases, most possibly due to variability in the technical work, droplet size variability, and analysis of the raw data. GMO quantification with dPCR and qPCR was comparable. As methods originally designed for qPCR performed well in dPCR systems, already validated qPCR assays can most generally be used for dPCR technology with the purpose of GMO detection. Graphical abstract The output of three different PCR-based platforms was assessed in an inter-laboratory comparison.

GC-C-IRMS in routine doping control practice: 3 years of drug testing data, quality control and evolution of the method.

PubMed

Polet, Michael; Van Eenoo, Peter

2015-06-01

In order to detect the misuse of endogenous anabolic steroids, doping control laboratories require methods that allow differentiation between endogenous steroids and their synthetic copies. Gas chromatography combustion isotope ratio mass spectrometry (GC-C-IRMS) is capable of measuring the carbon isotope ratio of urinary steroids and this allows differentiation between both. GC-C-IRMS and its application to doping control has evolved a lot during the last decade and so have the World Anti-Doping Agency (WADA) technical documents that describe how GC-C-IRMS should be applied. Especially the WADA technical document of 2014 introduced a number of obligatory quality controls and a fixed methodology that should be used by all the doping control laboratories. This document imposed more uniform methods between the laboratories in order to decrease the interlaboratory standard deviation and acquire similar results for the analysis of the same urine samples. In this paper, 3 years of drug testing data of our GC-C-IRMS method in routine doping control practice is described, with an emphasis on the new WADA technical document and its implementation. Useful data for other doping control laboratories is presented focussing on general method setup, quality control and data collected from routine samples. The paper concentrates on how IRMS results shift or remain similar by switching to the 2014 WADA technical document and gives insight in a straightforward approach to calculate the measurement uncertainty.

Development of Gold Standard Ion-Selective Electrode-Based Methods for Fluoride Analysis

PubMed Central

Martínez-Mier, E.A.; Cury, J.A.; Heilman, J.R.; Katz, B.P.; Levy, S.M.; Li, Y.; Maguire, A.; Margineda, J.; O’Mullane, D.; Phantumvanit, P.; Soto-Rojas, A.E.; Stookey, G.K.; Villa, A.; Wefel, J.S.; Whelton, H.; Whitford, G.M.; Zero, D.T.; Zhang, W.; Zohouri, V.

2011-01-01

Background/Aims: Currently available techniques for fluoride analysis are not standardized. Therefore, this study was designed to develop standardized methods for analyzing fluoride in biological and nonbiological samples used for dental research. Methods A group of nine laboratories analyzed a set of standardized samples for fluoride concentration using their own methods. The group then reviewed existing analytical techniques for fluoride analysis, identified inconsistencies in the use of these techniques and conducted testing to resolve differences. Based on the results of the testing undertaken to define the best approaches for the analysis, the group developed recommendations for direct and microdiffusion methods using the fluoride ion-selective electrode. Results Initial results demonstrated that there was no consensus regarding the choice of analytical techniques for different types of samples. Although for several types of samples, the results of the fluoride analyses were similar among some laboratories, greater differences were observed for saliva, food and beverage samples. In spite of these initial differences, precise and true values of fluoride concentration, as well as smaller differences between laboratories, were obtained once the standardized methodologies were used. Intraclass correlation coefficients ranged from 0.90 to 0.93, for the analysis of a certified reference material, using the standardized methodologies. Conclusion The results of this study demonstrate that the development and use of standardized protocols for F analysis significantly decreased differences among laboratories and resulted in more precise and true values. PMID:21160184

[Standardization of terminology in laboratory medicine I].

PubMed

Yoon, Soo Young; Yoon, Jong Hyun; Min, Won Ki; Lim, Hwan Sub; Song, Junghan; Chae, Seok Lae; Lee, Chang Kyu; Kwon, Jung Ah; Lee, Kap No

2007-04-01

Standardization of medical terminology is essential for data transmission between health-care institutions or clinical laboratories and for maximizing the benefits of information technology. Purpose of our study was to standardize the medical terms used in the clinical laboratory, such as test names, units, terms used in result descriptions, etc. During the first year of the study, we developed a standard database of concept names for laboratory terms, which covered the terms used in government health care centers, their branch offices, and primary health care units. Laboratory terms were collected from the electronic data interchange (EDI) codes from National Health Insurance Corporation (NHIC), Logical Observation Identifier Names and Codes (LOINC) database, community health centers and their branch offices, and clinical laboratories of representative university medical centers. For standard expression, we referred to the English-Korean/ Korean-English medical dictionary of Korean Medical Association and the rules for foreign language translation. Programs for mapping between LOINC DB and EDI code and for translating English to Korean were developed. A Korean standard laboratory terminology database containing six axial concept names such as components, property, time aspect, system (specimen), scale type, and method type was established for 7,508 test observations. Short names and a mapping table for EDI codes and Unified Medical Language System (UMLS) were added. Synonym tables for concept names, words used in the database, and six axial terms were prepared to make it easier to find the standard terminology with common terms used in the field of laboratory medicine. Here we report for the first time a Korean standard laboratory terminology database for test names, result description terms, result units covering most laboratory tests in primary healthcare centers.

LABORATORY ASSESSMENT OF THE PERMEABILITY AND DIFFUSION CHARACTERISTICS OF FLORIDA CONCRETES - PHASE I - METHODS DEVELOPMENT AND TESTING

EPA Science Inventory

The report gives results of Phase I of a laboratory assessment of the permeability and diffusion characteristics of Florida concretes. (NOTE: The ability of concrete to permit air flow under pressure (permeability) and the passage of radon gas without any pressure difference (dif...

75 FR 30041 - Medicare Program; Public Meeting in Calendar Year 2010 for New Clinical Laboratory Tests Payment...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1340-N... CY 2011 Clinical Laboratory Fee Schedule. The first method, called ``cross-walking,'' is used when a...-walk or gap-fill. II. Format This meeting to receive comments and recommendations (including...

[Urinalysis in Italy in 2006].

PubMed

Gai, M; Lanfranco, G

2007-01-01

Urinalysis and proteinuria testing represent fundamental tests for the clinician, even though they too often lack standardization. Through the Italian Society of Nephrology Mailing List we sent a questionnaire to 282 centers, in order to assess the state of the art in Italy in the year 2006. 82% of the questionnaires were completed (nephrology laboratories: 64%, general laboratories: 36%). The questionnaire dealt with the main steps of preparation, analysis and report of urinalysis, and proteinuria / microalbuminuria measurement. 85% of the centers use first morning urine, and 7% second morning urine; only 57% of the centers supply with written instructions, 189 laboratories (82%) have only one bright field microscope, rate and time of centrifugation are very varied among centers, different units of measurement are used in reports. Few laboratories measure routinely the proteinuria / creatininuria ratio, there is no agreement on the urine sample type for microalbuminuria assay, total urinary proteins are measured through different methods. 92% of the centers is endowed with an internal quality control system, but only 47% participate in an external quality control program. These data confirm the lack of standardization for urine analysis methods and procedures.

Improving diagnostic capability for HPV disease internationally within the NIH-NIAID-Division of AIDS Clinical Trial Networks

PubMed Central

Godfrey, Catherine C.; Michelow, Pamela M.; Godard, Mandana; Sahasrabuddhe, Vikrant V.; Darden, Janice; Firnhaber, Cynthia S.; Wetherall, Neal T.; Bremer, James; Coombs, Robert W.; Wilkin, Timothy

2014-01-01

Objectives To evaluate an external quality assurance (EQA) program for the laboratory diagnosis of human papillomavirus (HPV) disease that was established to improve international research capability within the Division of AIDS at the National Institute of Allergy and Infectious Disease–supported Adult AIDS Clinical Trials Group network. Methods A three-component EQA scheme was devised comprising assessments of diagnostic accuracy of cytotechnologists and pathologists using available EQA packages, review of quality and accuracy of clinical slides from local sites by an outside expert, and HPV DNA detection using the commercially available HPV test kit. Results Seven laboratories and 17 pathologists in Africa, India, and South America participated. EQA scores were suboptimal for standard packages in three of seven laboratories. There was good agreement between the local laboratory and the central reader 70% of the time (90% confidence interval, 42%-98%). Performance on the College of American Pathologists’ HPV DNA testing panel was successful in all laboratories tested. Conclusions The prequalifying EQA round identified correctable issues that will improve the laboratory diagnosis of HPV related cervical disease at the international sites and will provide a mechanism for ongoing education and continuous quality improvement. PMID:24225757

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

Lundstrom, Blake; Chakraborty, Sudipta; Lauss, Georg

This paper presents a concise description of state-of-the-art real-time simulation-based testing methods and demonstrates how they can be used independently and/or in combination as an integrated development and validation approach for smart grid DERs and systems. A three-part case study demonstrating the application of this integrated approach at the different stages of development and validation of a system-integrated smart photovoltaic (PV) inverter is also presented. Laboratory testing results and perspectives from two international research laboratories are included in the case study.

The use of digital PCR to improve the application of quantitative molecular diagnostic methods for tuberculosis.

PubMed

Devonshire, Alison S; O'Sullivan, Denise M; Honeyborne, Isobella; Jones, Gerwyn; Karczmarczyk, Maria; Pavšič, Jernej; Gutteridge, Alice; Milavec, Mojca; Mendoza, Pablo; Schimmel, Heinz; Van Heuverswyn, Fran; Gorton, Rebecca; Cirillo, Daniela Maria; Borroni, Emanuele; Harris, Kathryn; Barnard, Marinus; Heydenrych, Anthenette; Ndusilo, Norah; Wallis, Carole L; Pillay, Keshree; Barry, Thomas; Reddington, Kate; Richter, Elvira; Mozioğlu, Erkan; Akyürek, Sema; Yalçınkaya, Burhanettin; Akgoz, Muslum; Žel, Jana; Foy, Carole A; McHugh, Timothy D; Huggett, Jim F

2016-08-03

Real-time PCR (qPCR) based methods, such as the Xpert MTB/RIF, are increasingly being used to diagnose tuberculosis (TB). While qualitative methods are adequate for diagnosis, the therapeutic monitoring of TB patients requires quantitative methods currently performed using smear microscopy. The potential use of quantitative molecular measurements for therapeutic monitoring has been investigated but findings have been variable and inconclusive. The lack of an adequate reference method and reference materials is a barrier to understanding the source of such disagreement. Digital PCR (dPCR) offers the potential for an accurate method for quantification of specific DNA sequences in reference materials which can be used to evaluate quantitative molecular methods for TB treatment monitoring. To assess a novel approach for the development of quality assurance materials we used dPCR to quantify specific DNA sequences in a range of prototype reference materials and evaluated accuracy between different laboratories and instruments. The materials were then also used to evaluate the quantitative performance of qPCR and Xpert MTB/RIF in eight clinical testing laboratories. dPCR was found to provide results in good agreement with the other methods tested and to be highly reproducible between laboratories without calibration even when using different instruments. When the reference materials were analysed with qPCR and Xpert MTB/RIF by clinical laboratories, all laboratories were able to correctly rank the reference materials according to concentration, however there was a marked difference in the measured magnitude. TB is a disease where the quantification of the pathogen could lead to better patient management and qPCR methods offer the potential to rapidly perform such analysis. However, our findings suggest that when precisely characterised materials are used to evaluate qPCR methods, the measurement result variation is too high to determine whether molecular quantification of Mycobacterium tuberculosis would provide a clinically useful readout. The methods described in this study provide a means by which the technical performance of quantitative molecular methods can be evaluated independently of clinical variability to improve accuracy of measurement results. These will assist in ultimately increasing the likelihood that such approaches could be used to improve patient management of TB.

Comparison of Refractory Performance in Black Liquor Gasifiers and a Smelt Test System

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

Peascoe, RA

2001-09-25

Prior laboratory corrosion studies along with experience at the black liquor gasifier in New Bern, North Carolina, clearly demonstrate that serious material problems exist with the gasifier's refractory lining. Mullite-based and alumina-based refractories used at the New Bern facility suffered significant degradation even though they reportedly performed adequately in smaller scale systems. Oak Ridge National Laboratory's involvement in the failure analysis, and the initial exploration of suitable replacement materials, led to the realization that a simple and reliable, complementary method for refractory screening was needed. The development of a laboratory test system and its suitability for simulating the environment ofmore » black liquor gasifiers was undertaken. Identification and characterization of corrosion products were used to evaluate the test system as a rapid screening tool for refractory performance and as a predictor of refractory lifetime. Results from the test systems and pl ants were qualitatively similar.« less

Multiplex molecular testing for management of infectious gastroenteritis in a hospital setting: a comparative diagnostic and clinical utility study.

PubMed

Halligan, E; Edgeworth, J; Bisnauthsing, K; Bible, J; Cliff, P; Aarons, E; Klein, J; Patel, A; Goldenberg, S

2014-08-01

Laboratory diagnosis and clinical management of inpatients with diarrhoea is complex and time consuming. Tests are often requested sequentially and undertaken in different laboratories. This causes prolonged unnecessary presumptive isolation of patients, because most cases are non-infectious. A molecular multiplex test (Luminex(®) Gastrointestinal Pathogen Panel (GPP)) was compared with conventional testing over 8 months to determine diagnostic accuracy, turnaround times, laboratory costs, use of isolation facilities and user acceptability. A total of 262 (12%) patients had a pathogen detected by conventional methods compared with 483 (22.1%) by GPP. Most additional cases were detected in patients developing symptoms in the first 4 days of admission. Additional cases were detected because of presumed improved diagnostic sensitivity but also because clinicians had not requested the correct pathogen. Turnaround time (41.8 h) was faster than bacterial culture (66.5 h) and parasite investigation (66.5 h) but slower than conventional testing for Clostridium difficile (17.3 h) and viruses (27 h). The test could allow simplified requesting by clinicians and a consolidated laboratory workflow, reducing the overall number of specimens received by the laboratory. A total of 154 isolation days were saved at an estimated cost of £30 800. Consumables and labour were estimated at £150 641 compared with £63 431 for conventional testing. Multiplex molecular testing using a panel of targets allowed enhanced detection and a consolidated laboratory workflow. This is likely to be of greater benefit to cases that present within the first 4 days of hospital admission. © 2013 The Authors Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.

Dynamic spiking studies using the DNPH sampling train

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

Steger, J.L.; Knoll, J.E.

1996-12-31

The proposed aldehyde and ketone sampling method using aqueous 2,4-dinitrophenylhydrazine (DNPH) was evaluated in the laboratory and in the field. The sampling trains studied were based on the train described in SW 846 Method 0011. Nine compounds were evaluated: formaldehyde, acetaldehyde, quinone, acrolein, propionaldeyde, methyl isobutyl ketone, methyl ethyl ketone, acetophenone, and isophorone. In the laboratory, the trains were spiked both statistically and dynamically. Laboratory studies also investigated potential interferences to the method. Based on their potential to hydrolyze in acid solution to form formaldehyde, dimethylolurea, saligenin, s-trioxane, hexamethylenetetramine, and paraformaldehyde were investigated. Ten runs were performed using quadruplicate samplingmore » trains. Two of the four trains were dynamically spiked with the nine aldehydes and ketones. The test results were evaluated using the EPA method 301 criteria for method precision (< + pr - 50% relative standard deviation) and bias (correction factor of 1.00 + or - 0.30).« less

A teaching intervention for reading laboratory experiments in college-level introductory chemistry

NASA Astrophysics Data System (ADS)

Kirk, Maria Kristine

The purpose of this study was to determine the effects that a pre-laboratory guide, conceptualized as a "scientific story grammar," has on college chemistry students' learning when they read an introductory chemistry laboratory manual and perform the experiments in the chemistry laboratory. The participants (N = 56) were students enrolled in four existing general chemistry laboratory sections taught by two instructors at a women's liberal arts college. The pre-laboratory guide consisted of eight questions about the experiment, including the purpose, chemical species, variables, chemical method, procedure, and hypothesis. The effects of the intervention were compared with those of the traditional pre-laboratory assignment for the eight chemistry experiments. Measures included quizzes, tests, chemistry achievement test, science process skills test, laboratory reports, laboratory average, and semester grade. The covariates were mathematical aptitude and prior knowledge of chemistry and science processes, on which the groups differed significantly. The study captured students' perceptions of their experience in general chemistry through a survey and interviews with eight students. The only significant differences in the treatment group's performance were in some subscores on lecture items and laboratory items on the quizzes. An apparent induction period was noted, in that significant measures occurred in mid-semester. Voluntary study with the pre-laboratory guide by control students precluded significant differences on measures given later in the semester. The groups' responses to the survey were similar. Significant instructor effects on three survey items were corroborated by the interviews. The researcher's students were more positive about their pre-laboratory tasks, enjoyed the laboratory sessions more, and were more confident about doing chemistry experiments than the laboratory instructor's groups due to differences in scaffolding by the instructors.

Evaluation of ability of reference toxicity tests to identify stress in laboratory populations of the amphipod Hyalella azteca

USGS Publications Warehouse

McNulty, E.W.; Dwyer, F.J.; Ellersieck, Mark R.; Greer, E.I.; Ingersoll, C.G.; Rabeni, C.F.

1999-01-01

Standard methods for conducting toxicity tests imply that the condition of test organisms can be established using reference toxicity tests. However, only a limited number of studies have evaluated whether reference toxicity tests can actually be used to determine if organisms are in good condition at the start of a test. We evaluated the ability of reference toxicants to identify stress associated with starvation in laboratory populations of the amphipod Hyalella azteca using acute toxicity tests and four reference toxicants: KCl, CdCl2, sodium pentachlorophenate (NaPCP), and carbaryl. Stress associated with severe starvation was observed with exposure of amphipods to carbaryl or NaPCP but not with exposure to KCl or CdCl2 (i.e., lower LC50 with severe starvation). Although the LC50s for NaPCP and carbaryl were statistically different between starved and fed amphipods, this difference may not be biologically significant given the variability expected in acute lethality tests. Stress associated with sieving, heat shock, or cold shock of amphipods before the start of a test was not evident with exposure to carbaryl or KCl as reference toxicants. The chemicals evaluated in this study provided minimal information about the condition of the organisms used to start a toxicity test. Laboratories should periodically perform reference toxicity tests to assess the sensitivity of life stages or strains of test organisms. However, use of other test acceptability criteria required in standard methods such as minimum survival, growth, or reproduction of organisms in the control treatment at the end of a test, provides more useful information about the condition of organisms used to start a test compared to data generated from reference toxicity tests.

Application of laboratory and portable attenuated total reflectance infrared spectroscopic approaches for rapid quantification of alpaca serum immunoglobulin G

PubMed Central

Burns, Jennifer B.; Riley, Christopher B.; Shaw, R. Anthony; McClure, J. Trenton

2017-01-01

The objective of this study was to develop and compare the performance of laboratory grade and portable attenuated total reflectance infrared (ATR-IR) spectroscopic approaches in combination with partial least squares regression (PLSR) for the rapid quantification of alpaca serum IgG concentration, and the identification of low IgG (<1000 mg/dL), which is consistent with the diagnosis of failure of transfer of passive immunity (FTPI) in neonates. Serum samples (n = 175) collected from privately owned, healthy alpacas were tested by the reference method of radial immunodiffusion (RID) assay, and laboratory grade and portable ATR-IR spectrometers. Various pre-processing strategies were applied to the ATR-IR spectra that were linked to corresponding RID-IgG concentrations, and then randomly split into two sets: calibration (training) and test sets. PLSR was applied to the calibration set and calibration models were developed, and the test set was used to assess the accuracy of the analytical method. For the test set, the Pearson correlation coefficients between the IgG measured by RID and predicted by both laboratory grade and portable ATR-IR spectrometers was 0.91. The average differences between reference serum IgG concentrations and the two IR-based methods were 120.5 mg/dL and 71 mg/dL for the laboratory and portable ATR-IR-based assays, respectively. Adopting an IgG concentration <1000 mg/dL as the cut-point for FTPI cases, the sensitivity, specificity, and accuracy for identifying serum samples below this cut point by laboratory ATR-IR assay were 86, 100 and 98%, respectively (within the entire data set). Corresponding values for the portable ATR-IR assay were 95, 99 and 99%, respectively. These results suggest that the two different ATR-IR assays performed similarly for rapid qualitative evaluation of alpaca serum IgG and for diagnosis of IgG <1000 mg/dL, the portable ATR-IR spectrometer performed slightly better, and provides more flexibility for potential application in the field. PMID:28651006

Application of laboratory and portable attenuated total reflectance infrared spectroscopic approaches for rapid quantification of alpaca serum immunoglobulin G.

PubMed

Elsohaby, Ibrahim; Burns, Jennifer B; Riley, Christopher B; Shaw, R Anthony; McClure, J Trenton

2017-01-01

The objective of this study was to develop and compare the performance of laboratory grade and portable attenuated total reflectance infrared (ATR-IR) spectroscopic approaches in combination with partial least squares regression (PLSR) for the rapid quantification of alpaca serum IgG concentration, and the identification of low IgG (<1000 mg/dL), which is consistent with the diagnosis of failure of transfer of passive immunity (FTPI) in neonates. Serum samples (n = 175) collected from privately owned, healthy alpacas were tested by the reference method of radial immunodiffusion (RID) assay, and laboratory grade and portable ATR-IR spectrometers. Various pre-processing strategies were applied to the ATR-IR spectra that were linked to corresponding RID-IgG concentrations, and then randomly split into two sets: calibration (training) and test sets. PLSR was applied to the calibration set and calibration models were developed, and the test set was used to assess the accuracy of the analytical method. For the test set, the Pearson correlation coefficients between the IgG measured by RID and predicted by both laboratory grade and portable ATR-IR spectrometers was 0.91. The average differences between reference serum IgG concentrations and the two IR-based methods were 120.5 mg/dL and 71 mg/dL for the laboratory and portable ATR-IR-based assays, respectively. Adopting an IgG concentration <1000 mg/dL as the cut-point for FTPI cases, the sensitivity, specificity, and accuracy for identifying serum samples below this cut point by laboratory ATR-IR assay were 86, 100 and 98%, respectively (within the entire data set). Corresponding values for the portable ATR-IR assay were 95, 99 and 99%, respectively. These results suggest that the two different ATR-IR assays performed similarly for rapid qualitative evaluation of alpaca serum IgG and for diagnosis of IgG <1000 mg/dL, the portable ATR-IR spectrometer performed slightly better, and provides more flexibility for potential application in the field.

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

Wiedenman, B. J.; White, T. L.; Mahannah, R. N.

Ion Chromatography (IC) is the principal analytical method used to support studies of Sludge Reciept and Adjustment Tank (SRAT) chemistry at DWPF. A series of prior analytical ''Round Robin'' (RR) studies included both supernate and sludge samples from SRAT simulant, previously reported as memos, are tabulated in this report.2,3 From these studies it was determined to standardize IC column size to 4 mm diameter, eliminating the capillary column from use. As a follow on test, the DWPF laboratory, the PSAL laboratory, and the AD laboratory participated in the current analytical RR to determine a suite of anions in SRAT simulantmore » by IC, results also are tabulated in this report. The particular goal was to confirm the laboratories ability to measure and quantitate glycolate ion. The target was + or - 20% inter-lab agreement of the analyte averages for the RR. Each of the three laboratories analyzed a batch of 12 samples. For each laboratory, the percent relative standard deviation (%RSD) of the averages on nitrate, glycolate, and oxalate, was 10% or less. The three laboratories all met the goal of 20% relative agreement for nitrate and glycolate. For oxalate, the PSAL laboratory reported an average value that was 20% higher than the average values reported by the DWPF laboratory and the AD laboratory. Because of this wider window of agreement, it was concluded to continue the practice of an additional acid digestion for total oxalate measurement. It should also be noted that large amounts of glycolate in the SRAT samples will have an impact on detection limits of near eluting peaks, namely Fluoride and Formate. A suite of scoping experiments are presented in the report to identify and isolate other potential interlaboratory disceprancies. Specific ion chromatography inter-laboratory method conditions and differences are tabulated. Most differences were minor but there are some temperature control equipment differences that are significant leading to a recommendation of a heated jacket for analytical columns that are remoted for use in radiohoods. A suggested method improvement would be to implement column temperture control at a temperature slightly above ambient to avoid peak shifting due to temperature fluctuations. Temperature control in this manner would improve short and longer term peak retention time stability. An unknown peak was observed during the analysis of glycolic acid and SRAT simulant. The unknown peak was determined to best match diglycolic acid. The development of a method for acetate is summaraized, and no significant amount of acetate was observed in the SRAT products tested. In addition, an alternative Gas Chromatograph (GC) method for glycolate is summarized.« less

A high-performance liquid chromatography method for the serotonin release assay is equivalent to the radioactive method.

PubMed

Sono-Koree, N K; Crist, R A; Frank, E L; Rodgers, G M; Smock, K J

2016-02-01

The serotonin release assay (SRA) is considered the gold standard laboratory test for heparin-induced thrombocytopenia (HIT). The historic SRA method uses platelets loaded with radiolabeled serotonin to evaluate platelet activation by HIT immune complexes. However, a nonradioactive method is desirable. We report the performance characteristics of a high-performance liquid chromatography (HPLC) SRA method. We validated the performance characteristics of an HPLC-SRA method, including correlation with a reference laboratory using the radioactive method. Serotonin released from reagent platelets was quantified by HPLC using fluorescent detection. Results were expressed as % release and classified as positive, negative, or indeterminate based on previously published cutoffs. Serum samples from 250 subjects with suspected HIT were tested in the HPLC-SRA and with the radioactive method. Concordant classifications were observed in 230 samples (92%). Sera from 41 healthy individuals tested negative. Between-run imprecision studies showed standard deviation of <6 (% release) for positive, weak positive, and negative serum pools. Stability studies demonstrated stability after two freeze-thaw cycles or up to a week of refrigeration. The HPLC-SRA has robust performance characteristics, equivalent to the historic radioactive method, but avoids the complexities of working with radioactivity. © 2015 John Wiley & Sons Ltd.

A Study on the Effects of Sympathetic Skin Response Parameters in Diagnosis of Fibromyalgia Using Artificial Neural Networks.

PubMed

Ozkan, Ozhan; Yildiz, Murat; Arslan, Evren; Yildiz, Sedat; Bilgin, Suleyman; Akkus, Selami; Koyuncuoglu, Hasan R; Koklukaya, Etem

2016-03-01

Fibromyalgia syndrome (FMS), usually observed commonly in females over age 30, is a rheumatic disease accompanied by extensive chronic pain. In the diagnosis of the disease non-objective psychological tests and physiological tests and laboratory test results are evaluated and clinical experiences stand out. However, these tests are insufficient in differentiating FMS with similar diseases that demonstrate symptoms of extensive pain. Thus, objective tests that would help the diagnosis are needed. This study analyzes the effect of sympathetic skin response (SSR) parameters on the auxiliary tests used in FMS diagnosis, the laboratory tests and physiological tests. The study was conducted in Suleyman Demirel University, Faculty of Medicine, Physical Medicine and Rehabilitation Clinic in Turkey with 60 patients diagnosed with FMS for the first time and a control group of 30 healthy individuals. In the study all participants underwent laboratory tests (blood tests), certain physiological tests (pulsation, skin temperature, respiration) and SSR measurements. The test data and SSR parameters obtained were classified using artificial neural network (ANN). Finally, in the ANN framework, where only laboratory and physiological test results were used as input, a simulation result of 96.51 % was obtained, which demonstrated diagnostic accuracy. This data, with the addition of SSR parameter values obtained increased to 97.67 %. This result including SSR parameters - meaning a higher diagnostic accuracy - demonstrated that SSR could be a new auxillary diagnostic method that could be used in the diagnosis of FMS.

Detection of BRAF V600 Mutations in Melanoma: Evaluation of Concordance between the Cobas® 4800 BRAF V600 Mutation Test and the Methods Used in French National Cancer Institute (INCa) Platforms in a Real-Life Setting

PubMed Central

Mourah, Samia; Denis, Marc G.; Narducci, Fabienne Escande; Solassol, Jérôme; Merlin, Jean-Louis; Sabourin, Jean-Christophe; Scoazec, Jean-Yves; Ouafik, L’Houcine; Emile, Jean-François; Heller, Remy; Souvignet, Claude; Bergougnoux, Loïc; Merlio, Jean-Philippe

2015-01-01

Vemurafenib is approved for the treatment of metastatic melanoma in patients with BRAF V600 mutation. In pivotal clinical trials, BRAF testing has always been done with the approved cobas 4800 BRAF test. In routine practice, several methods are available and are used according to the laboratories usual procedures. A national, multicenter, non-interventional study was conducted with prospective and consecutive collection of tumor samples. A parallel evaluation was performed in routine practice between the cobas 4800 BRAF V600 mutation test and home brew methods (HBMs) of 12 national laboratories, labelled and funded by the French National Cancer Institute (INCa). For 420 melanoma samples tested, the cobas method versus HBM showed a high concordance (93.3%; kappa = 0.86) in BRAF V600 genotyping with similar mutation rates (34.0% versus 35.7%, respectively). Overall, 97.4% and 98.6% of samples gave valid results using the cobas and HBM, respectively. Of the 185 samples strictly fulfilling the cobas guidelines, the concordance rate was even higher (95.7%; kappa = 0.91; 95%CI [0.85; 0.97]). Out of the 420 samples tested, 28 (6.7%) showed discordance between HBM and cobas. This prospective study shows a high concordance rate between the cobas 4800 BRAF V600 test and home brew methods in the routine detection of BRAF V600E mutations. PMID:25789737

Comparison between the Standardized Clinical and Laboratory Standards Institute M38-A2 Method and a 2,3-Bis(2-Methoxy-4-Nitro-5-[(Sulphenylamino)Carbonyl]-2H-Tetrazolium Hydroxide- Based Method for Testing Antifungal Susceptibility of Dermatophytes ▿

PubMed Central

Shehata, Atef S.; Mukherjee, Pranab K.; Ghannoum, Mahmoud A.

2008-01-01

In this study, we determined the utility of a 2,3-bis(2-methoxy-4-nitro-5-[(sulfenylamino)carbonyl]-2H-tetrazolium hydroxide (XTT)-based assay for determining antifungal susceptibilities of dermatophytes to terbinafine, ciclopirox, and voriconazole in comparison to the Clinical and Laboratory Standards Institute (CLSI) M38-A2 method. Forty-eight dermatophyte isolates, including Trichophyton rubrum (n = 15), Trichophyton mentagrophytes (n = 7), Trichophyton tonsurans (n = 11), and Epidermophyton floccosum (n = 13), and two quality control strains, were tested. In the XTT-based method, MICs were determined spectrophotometrically at 490 nm after addition of XTT and menadione. For the CLSI method, the MICs were determined visually. With T. rubrum, the XTT assay revealed MIC ranges of 0.004 to >64 μg/ml, 0.125 to 0.25 μg/ml, and 0.008 to 0.025 μg/ml for terbinafine, ciclopirox, and voriconazole, respectively. Similar MIC ranges were obtained against T. rubrum by using the CLSI method. Additionally, when tested with T. mentagrophytes, T. tonsurans, and E. floccosum isolates, the XTT and CLSI methods resulted in comparable MIC ranges. Both methods revealed similar lowest drug concentrations that inhibited 90% of the isolates for the majority of tested drug-dermatophyte combinations. The levels of agreement within 1 dilution between both methods were as follows: 100% with terbinafine, 97.8% with ciclopirox, and 89.1% with voriconazole. However, the agreement within 2 dilutions between these two methods was 100% for all tested drugs. Our results revealed that the XTT assay can be a useful tool for antifungal susceptibility testing of dermatophytes. PMID:18832129

Validation of Dissolution Testing with Biorelevant Media: An OrBiTo Study.

PubMed

Mann, James; Dressman, Jennifer; Rosenblatt, Karin; Ashworth, Lee; Muenster, Uwe; Frank, Kerstin; Hutchins, Paul; Williams, James; Klumpp, Lukas; Wielockx, Kristina; Berben, Philippe; Augustijns, Patrick; Holm, Rene; Hofmann, Michael; Patel, Sanjaykumar; Beato, Stefania; Ojala, Krista; Tomaszewska, Irena; Bruel, Jean-Luc; Butler, James

2017-12-04

Dissolution testing with biorelevant media has become widespread in the pharmaceutical industry as a means of better understanding how drugs and formulations behave in the gastrointestinal tract. Until now, however, there have been few attempts to gauge the reproducibility of results obtained with these methods. The aim of this study was to determine the interlaboratory reproducibility of biorelevant dissolution testing, using the paddle apparatus (USP 2). Thirteen industrial and three academic laboratories participated in this study. All laboratories were provided with standard protocols for running the tests: dissolution in FaSSGF to simulate release in the stomach, dissolution in a single intestinal medium, FaSSIF, to simulate release in the small intestine, and a "transfer" (two-stage) protocol to simulate the concentration profile when conditions are changed from the gastric to the intestinal environment. The test products chosen were commercially available ibuprofen tablets and zafirlukast tablets. The biorelevant dissolution tests showed a high degree of reproducibility among the participating laboratories, even though several different batches of the commercially available medium preparation powder were used. Likewise, results were almost identicalbetween the commercial biorelevant media and those produced in-house. Comparing results to previous ring studies, including those performed with USP calibrator tablets or commercially available pharmaceutical products in a single medium, the results for the biorelevant studies were highly reproducible on an interlaboratory basis. Interlaboratory reproducibility with the two-stage test was also acceptable, although the variability was somewhat greater than with the single medium tests. Biorelevant dissolution testing is highly reproducible among laboratories and can be relied upon for cross-laboratory comparisons.

Use of FTA gene guard filter paper for the storage and transportation of tumor cells for molecular testing.

PubMed

Dobbs, Larry J; Madigan, Merle N; Carter, Alexis B; Earls, Lori

2002-01-01

Efficient methods of storing tumor specimens for molecular testing are needed in the modern surgical pathology laboratory. The FTA Gene Guard system is a novel method for the collection and room temperature storage of blood samples for DNA testing. The method uses index card-sized filter papers that provide an ideal medium on which to store tumor specimens for DNA testing. To determine whether FTA filter paper can be used in the surgical pathology laboratory to store tumor cells for DNA testing. Cell suspensions were prepared from 60 surgical specimens, and DNA was extracted either immediately or after storage on FTA paper. The DNA extracted by each method was tested by polymerase chain reaction (PCR) for the beta-globin and interferon gamma genes, and the results were compared. Fifteen lymph node specimens stored on FTA paper were then tested for immunoglobulin heavy chain (IgH) gene rearrangement by PCR, and these results were compared with those obtained for immediately extracted DNA. University medical center. The DNA extracted from cells stored on FTA paper performed as well in the PCR as the freshly extracted DNA in nearly all cases (>95%). The results of tests for IgH gene rearrangements showed 100% concordance between the 2 methods of DNA extraction.Conclusion.-Cells from surgical specimens can be stored on FTA paper for extended lengths of time, and DNA can be extracted from these cells for PCR-based testing. FTA filter paper is a reliable medium for the storage and/or transport of tumor cells for PCR-based DNA analysis.

Local lymph node assay: how testing laboratories apply OECD TG 429 for REACH purposes.

PubMed

Rovida, Costanza

2011-01-01

The Local Lymph Node Assay (LLNA) is the official method for assessing the allergic contact dermatitis potential of chemicals for the purposes of REACH regulation. The LLNA went through a validation process that allowed the delineation of a robust protocol for performing new tests. The OECD accepted this method in 2002 and published OECD TG 429. The European Chemical Agency (ECHA) recently published data that were submitted in the registration dossiers of chemicals. This database was analysed to determine how testing laboratories apply OECD TG 429. This analysis comes after a detailed analysis of four full study reports that were also prepared for REACH purposes. Although the majority of the tests are fully compliant with OECD TG 429, some showed major deviations, and a number of others used more animals than necessary. This suggests that in vivo tests need to be planned more carefully and consciously to obtain meaningful results with the minimum animal number necessary.

Analysis of laboratory testing results collected in an enhanced chlamydia surveillance system in Australia, 2008–2010

PubMed Central

2014-01-01

Background Chlamydial infection is the most common notifiable disease in Australia, Europe and the US. Australian notifications of chlamydia rose four-fold from 20,274 cases in 2002 to 80,846 cases in 2011; the majority of cases were among young people aged less than 29 years. Along with test positivity rates, an understanding of the number of tests performed and the demographics of individuals being tested are key epidemiological indicators. The ACCESS Laboratory Network was established in 2008 to address this issue. Methods The ACCESS Laboratory Network collected chlamydia testing data from 15 laboratories around Australia over a three-year period using data extraction software. All chlamydia testing data from participating laboratories were extracted from the laboratory information system; patient identifiers converted to a unique, non-reversible code and de-identified data sent to a single database. Analysis of data by anatomical site included all specimens, but in age and sex specific analysis, only one testing episode was counted. Results From 2008 to 2010 a total of 628,295 chlamydia tests were referred to the 15 laboratories. Of the 592,626 individual episodes presenting for testing, 70% were from female and 30% from male patients. In female patients, chlamydia positivity rate was 6.4% overall; the highest rate in 14 year olds (14.3%). In male patients, the chlamydia positivity rate was 9.4% overall; the highest in 19 year olds (16.5%). The most common sample type was urine (57%). In 3.2% of testing episodes, multiple anatomical sites were sampled. Urethral swabs gave the highest positivity rate for all anatomical sites in both female (7.7%) and male patients (14%), followed by urine (7.6% and 9.4%, respectively) and eye (6.3% and 7.9%, respectively). Conclusions The ACCESS Laboratory Network data are unique in both number and scope and are representative of chlamydia testing in both general practice and high-risk clinics. The findings from these data highlight much lower levels of testing in young people aged 20 years or less; in particular female patients aged less than 16 years, despite being the group with the highest positivity rate. Strategies are needed to increase the uptake of testing in this high-risk group. PMID:24920016

Rapid high temperature field test method for evaluation of geothermal calcite scale inhibitors

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

Asperger, R.G.

1982-08-01

A test method is described which allows the rapid field testing of calcite scale inhibitors in high- temperature geothermal brines. Five commercial formulations, chosen on the basis of laboratory screening tests, were tested in brines with low total dissolved solids at ca 500 F. Four were found to be effective; of these, 2 were found to be capable of removing recently deposited scale. One chemical was tested in the full-flow brine line for 6 wks. It was shown to stop a severe surface scaling problem at the well's control valve, thus proving the viability of the rapid test method. (12more » refs.)« less

External quality assurance of HER2 fluorescence in situ hybridisation testing: results of a UK NEQAS pilot scheme

PubMed Central

Bartlett, John M S; Ibrahim, Merdol; Jasani, Bharat; Morgan, John M; Ellis, Ian; Kay, Elaine; Magee, Hilary; Barnett, Sarah; Miller, Keith

2007-01-01

Background and Aims Trastuzumab provides clinical benefit for advanced and early breast cancer patients whose tumours over‐express or have gene amplification of the HER2 oncogene. The UK National External Quality Assessment Scheme (NEQAS) for immunohistochemical testing was established to assess and improve the quality of HER2 immunohistochemical testing. However, until recently, no provision was available for HER2 fluorescence in situ hybridisation (FISH) testing. A pilot scheme was set up to review the performance of FISH testing in clinical diagnostic laboratories. Methods FISH was performed in 6 reference and 31 participating laboratories using a cell line panel with known HER2 status. Results Using results from reference laboratories as a criterion for acceptable performance, 60% of all results returned by participants were appropriate and 78% either appropriate or acceptable. However, 22.4% of results returned were deemed inappropriate, including 13 cases (4.2%) where a misdiagnosis would have been made had these been clinical specimens. Conclusions The results of three consecutive runs show that both reference laboratories and a proportion of routine clinical diagnostic (about 25%) centres can consistently achieve acceptable quality control of HER2 testing. Data from a significant proportion of participating laboratories show that further steps are required, including those taken via review of performance under schemes such as NEQAS, to improve quality of HER2 testing by FISH in the “real world”. PMID:16963466

Enhancing maximum measurable sound reduction index using sound intensity method and strong receiving room absorption.

PubMed

Hongisto, V; Lindgren, M; Keränen, J

2001-01-01

The sound intensity method is usually recommended instead of the pressure method in the presence of strong flanking transmission. Especially when small and/or heavy specimens are tested, the flanking often causes problems in laboratories practicing only the pressure method. The purpose of this study was to determine experimentally the difference between the maximum sound reduction indices obtained by the intensity method, RI,max, and by the pressure method, Rmax. In addition, the influence of adding room absorption to the receiving room was studied. The experiments were carried out in an ordinary two-room test laboratory. The exact value of RI,max was estimated by applying a fitting equation to the measured data points. The fitting equation involved the dependence of the pressure-intensity indicator on measured acoustical parameters. In an empty receiving room, the difference between RI,max and Rmax was 4-15 dB, depending on frequency. When the average reverberation time was reduced from 3.5 to 0.6 s, the values of RI,max increased by 2-10 dB compared to the results in the empty room. Thus, it is possible to measure wall structures having 9-22 dB better sound reduction index using the intensity method than with the pressure method. This facilitates the measurements of small and/or heavy specimens in the presence of flanking. Moreover, when new laboratories are designed, the intensity method is an alternative to the pressure method which presupposes expensive isolation structures between the rooms.

Cognitive tests predict real-world errors: the relationship between drug name confusion rates in laboratory-based memory and perception tests and corresponding error rates in large pharmacy chains.

PubMed

Schroeder, Scott R; Salomon, Meghan M; Galanter, William L; Schiff, Gordon D; Vaida, Allen J; Gaunt, Michael J; Bryson, Michelle L; Rash, Christine; Falck, Suzanne; Lambert, Bruce L

2017-05-01

Drug name confusion is a common type of medication error and a persistent threat to patient safety. In the USA, roughly one per thousand prescriptions results in the wrong drug being filled, and most of these errors involve drug names that look or sound alike. Prior to approval, drug names undergo a variety of tests to assess their potential for confusability, but none of these preapproval tests has been shown to predict real-world error rates. We conducted a study to assess the association between error rates in laboratory-based tests of drug name memory and perception and real-world drug name confusion error rates. Eighty participants, comprising doctors, nurses, pharmacists, technicians and lay people, completed a battery of laboratory tests assessing visual perception, auditory perception and short-term memory of look-alike and sound-alike drug name pairs (eg, hydroxyzine/hydralazine). Laboratory test error rates (and other metrics) significantly predicted real-world error rates obtained from a large, outpatient pharmacy chain, with the best-fitting model accounting for 37% of the variance in real-world error rates. Cross-validation analyses confirmed these results, showing that the laboratory tests also predicted errors from a second pharmacy chain, with 45% of the variance being explained by the laboratory test data. Across two distinct pharmacy chains, there is a strong and significant association between drug name confusion error rates observed in the real world and those observed in laboratory-based tests of memory and perception. Regulators and drug companies seeking a validated preapproval method for identifying confusing drug names ought to consider using these simple tests. By using a standard battery of memory and perception tests, it should be possible to reduce the number of confusing look-alike and sound-alike drug name pairs that reach the market, which will help protect patients from potentially harmful medication errors. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Diagnostic performance of smear microscopy and incremental yield of Xpert in detection of pulmonary tuberculosis in Rwanda.

PubMed

Ngabonziza, Jean Claude Semuto; Ssengooba, Willy; Mutua, Florence; Torrea, Gabriela; Dushime, Augustin; Gasana, Michel; Andre, Emmanuel; Uwamungu, Schifra; Nyaruhirira, Alaine Umubyeyi; Mwaengo, Dufton; Muvunyi, Claude Mambo

2016-11-08

Tuberculosis control program of Rwanda is currently phasing in light emitting diode-fluorescent microscopy (LED-FM) as an alternative to Ziehl-Neelsen (ZN) smear microscopy. This, alongside the newly introduced Xpert (Cepheid, Sunnyvale, CA, USA) is expected to improve diagnosis of tuberculosis and detection of rifampicin resistance in patients at health facilities. We assessed the accuracy of smear microscopy and the incremental sensitivity of Xpert at tuberculosis laboratories in Rwanda. This was a cross-sectional study involving four laboratories performing ZN and four laboratories performing LED-FM microscopy. The laboratories include four intermediate (ILs) and four peripheral (PLs) laboratories. After smear microscopy, the left-over of samples, of a single early-morning sputum from 648 participants, were tested using Xpert and mycobacterial culture as a reference standard. Sensitivity of each test was compared and the incremental sensitivity of Xpert after a negative smear was assessed. A total of 96 presumptive pulmonary tuberculosis participants were culture positive for M. tuberculosis. The overall sensitivity in PL of ZN was 55.1 % (40.2-69.3 %), LED-FM was 37 % (19.4-57.6 %) and Xpert was 77.6 % (66.6-86.4 %) whereas in ILs the same value for ZN was 58.3 % (27.7-84.8 %), LED-FM was 62.5 % (24.5-91.5 %) and Xpert was 90 (68.3-98.8 %). The sensitivity for all tests was significantly higher among HIV-negative individuals (all test p <0.05). The overall incremental sensitivity of Xpert over smear microscopy was 32.3 %; p < 0.0001. The incremental sensitivity of Xpert was statistically significant for both smear methods at PL (32.9 %; p = 0.001) but not at the ILs (30 %; p = 0.125) for both smear methods. Our study findings of the early implementation of the LED-FM did not reveal significant increment in sensitivity compared to the method being phased out (ZN). This study showed a significant incremental sensitivity for Xpert from both smear methods at peripheral centers where majority of TB patients are diagnosed. Overall our findings support the recommendation for Xpert as an initial diagnostic test in adults and children presumed to have TB.

The efficacy of semi-quantitative urine protein-to-creatinine (P/C) ratio for the detection of significant proteinuria in urine specimens in health screening settings.

PubMed

Chang, Chih-Chun; Su, Ming-Jang; Ho, Jung-Li; Tsai, Yu-Hui; Tsai, Wei-Ting; Lee, Shu-Jene; Yen, Tzung-Hai; Chu, Fang-Yeh

2016-01-01

Urine protein detection could be underestimated using the conventional dipstick method because of variations in urine aliquots. This study aimed to assess the efficacy of the semi-quantitative urine protein-to-creatinine (P/C) ratio compared with other laboratory methods. Random urine samples were requested from patients undergoing chronic kidney disease screening. Significant proteinuria was determined by the quantitative P/C ratio of at least 150 mg protein/g creatinine. The semi-quantitative P/C ratio, dipstick protein and quantitative protein concentrations were compared and analyzed. In the 2932 urine aliquots, 156 (5.3 %) urine samples were considered as diluted and 60 (39.2 %) were found as significant proteinuria. The semi-quantitative P/C ratio testing had the best sensitivity (70.0 %) and specificity (95.9 %) as well as the lowest underestimation rate (0.37 %) when compared to other laboratory methods in the study. In the semi-quantitative P/C ratio test, 19 (12.2 %) had positive, 52 (33.3 %) had diluted, and 85 (54.5 %) had negative results. Of those with positive results, 7 (36.8 %) were positive detected by traditional dipstick urine protein test, and 9 (47.4 %) were positive detected by quantitative urine protein test. Additionally, of those with diluted results, 25 (48.1 %) had significant proteinuria, and all were assigned as no significant proteinuria by both tests. The semi-quantitative urine P/C ratio is clinically applicable based on its better sensitivity and screening ability for significant proteinuria than other laboratory methods, particularly in diluted urine samples. To establish an effective strategy for CKD prevention, urine protein screening with semi-quantitative P/C ratio could be considered.

[Laboratory diagnosis of genital herpes--direct immunofluorescence method].

PubMed

Majewska, Anna; Romejko-Wolniewicz, Ewa; Zareba-Szczudlik, Julia; Kilijańczyk, Marek; Gajewska, Małgorzata; Młynarczyk, Grazyna

2013-07-01

Aim of the study was to determine clinical usefulness of direct immunofluorescence method in the laboratory diagnosis of genital herpes in women. Overall 187 anogenital swabs were collected from 120 women. Using a dacron-tipped applicator 83 swabs were collected from women suspected of genital herpes and 104 from patients with no signs of genital infection. All samples were tested using cell culture (Vero cell line) and then direct immunofluorescence method (DIF) for the identification of antigens of herpes simplex viruses: HSV-1 and HSV-2. Characteristic cytopathic effect (CPE), indicative of alphaherpesvirus infection, was observed in 43.4% of cultures with clinical specimens collected from women with suspected genital herpes and in 29.8% of cultures of clinical specimens taken from patients with no clinical symptoms of genital herpes. Herpes simplex viruses were determined in 73 samples by direct immunofluorescence method after amplification of the virus in cell culture. The DIF test confirmed the diagnosis based on the microscopic CPE observation in 85%. In 15% of samples (taken from pregnant women without clinical signs of infection) we reported positive immunofluorescence in the absence of CPE. The frequency of antigen detection was statistically significantly higher in samples that were positive by culture study (chi-square test with Yates's correction, p < 0.01). This method proved to be highly sensitive (97%) in women with clinically suspected infection. High negative predictive value (99%) proves the clinical utility of the DIF in these group of patients. In asymptomatic infections, viral antigens were detected most frequently in the swabs from the cervical canal, and in cases of suspected genital herpes in swabs taken from the vestibule of the vagina and the vulva. However, there was no statistically significant difference in the frequency of detection of Herpes Simplex Virus antigens in specimens from different parts of the genital tract in both groups of women (chi-square test, p > 0.05). In our study HHV-1 was the main causative agent of genital herpes. The growing worldwide prevalence of genital herpes, challenges with the clinical diagnosis, and availability of effective antiviral therapy are the main reasons for a growing interest in rapid, proper laboratory diagnosis of infected patients. Optimal testing diagnostic algorithm depends on patient population, clinical circumstances and availability. Our results indicated that combination of laboratory tests may help to establish the diagnosis if genital herpes is suspected but there are no typical signs.

Test method for assessing resistance of pine lumber and waferboard to mold

Treesearch

Carol A. Clausen; Michael West

2005-01-01

Methods are needed to evaluate the ability of framing lumber and composite construction materials to withstand mold growth when they are exposed to rain between manufacture and installation. A laboratory-controlled rain chamber was developed to expose biocide-treated specimens of pine lumber and waferboard to bi-weekly wetting followed by re-inoculation with test fungi...

Using pathology-specific laboratory profiles in Clinical Pathology to reduce inappropriate test requesting: two completed audit cycles

PubMed Central

2012-01-01

Background Systematic reviews have shown that, although well prepared, the Consensus Guidelines have failed to change clinical practice. In the healthcare district of Castelnovo né Monti (Reggio Emilia, Italy), it became necessary for the GPs and Clinical Pathologists to work together to jointly define laboratory profiles. Methods Observational study with two cycles of retrospective audit on test request forms, in a primary care setting. Objectives of the study were to develop pathology-specific laboratory profiles and to increase the number of provisional diagnoses on laboratory test request forms. A Multiprofessional Multidisciplinary Inter-hospital Work Team developed pathology-specific laboratory profiles for more effective test requesting. After 8 training sessions that used a combined strategy with multifaceted interventions, the 23 General Practitioners (GPs) in the trial district (Castelnovo nè Monti) tested the profiles; the 21 GPs in the Puianello district were the control group; all GPs in both districts participated in the trial. All laboratory tests for both healthcare districts are performed at the Laboratory located in the trial district. A baseline and a 1-year audit were performed in both districts on the GPs’ request forms. Results Seven pathology-specific laboratory profiles for outpatients were developed. In the year after the first audit cycle: 1) the number of tests requested in the trial district was distinctly lower than that in the previous year, with a decrease of about 5% (p < 0.001); 2) the provisional diagnosis on the request forms was 52.8% in the trial district and 42% in the control district (P < 0.001); 3) the decrease of the number of tests on each request form was much more marked in the trial district (8.73 vs. 10.77; p < 0.001). Conclusions The first audit cycle showed a significant decrease in the number of tests ordered only in the trial district. The combined strategy used in this study improved the prescriptive compliance of most of the GPs involved. The presence of the clinical pathologist is seen as an added value. PMID:22759353

[Examination of drinking water used in livestock production. Microbiological and physico-chemical methods. Ready to use test kits in field experiments].

PubMed

Sassen, J

2000-08-01

Livestock health care service is very much involved and interested in surveillance of the drinking water as well. However, in order to examine the water immediately "on the fly", test kits have to be provided, which offer results comparable to these obtained in the laboratories according to official prescription. The German Army was confronted with a similar situation during the secently performed mission in crisis regions. At the early state of a mission usually laboratory equipment is not yet established. Therefore a set of test kits was compiled suitable for mobile microbiological examination of drinking water. This set was excessively examined comparison with reference methods. In conclusion it is shown, that the mobile set gains equal or even better results compared to those obtained according to legally prescribed standard procedures.

Combined target factor analysis and Bayesian soft-classification of interference-contaminated samples: forensic fire debris analysis.

PubMed

Williams, Mary R; Sigman, Michael E; Lewis, Jennifer; Pitan, Kelly McHugh

2012-10-10

A bayesian soft classification method combined with target factor analysis (TFA) is described and tested for the analysis of fire debris data. The method relies on analysis of the average mass spectrum across the chromatographic profile (i.e., the total ion spectrum, TIS) from multiple samples taken from a single fire scene. A library of TIS from reference ignitable liquids with assigned ASTM classification is used as the target factors in TFA. The class-conditional distributions of correlations between the target and predicted factors for each ASTM class are represented by kernel functions and analyzed by bayesian decision theory. The soft classification approach assists in assessing the probability that ignitable liquid residue from a specific ASTM E1618 class, is present in a set of samples from a single fire scene, even in the presence of unspecified background contributions from pyrolysis products. The method is demonstrated with sample data sets and then tested on laboratory-scale burn data and large-scale field test burns. The overall performance achieved in laboratory and field test of the method is approximately 80% correct classification of fire debris samples. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

EVALUATION OF ARG-1 SAMPLES PREPARED BY CESIUM CARBONATE DISSOLUTION DURING THE ISOLOK SME ACCEPTABILITY TESTING

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

Edwards, T.; Hera, K.; Coleman, C.

2011-12-05

Evaluation of Defense Waste Processing Facility (DWPF) Chemical Process Cell (CPC) cycle time identified several opportunities to improve the CPC processing time. The Mechanical Systems & Custom Equipment Development (MS&CED) Section of the Savannah River National Laboratory (SRNL) recently completed the evaluation of one of these opportunities - the possibility of using an Isolok sampling valve as an alternative to the Hydragard valve for taking DWPF process samples at the Slurry Mix Evaporator (SME). The use of an Isolok for SME sampling has the potential to improve operability, reduce maintenance time, and decrease CPC cycle time. The SME acceptability testingmore » for the Isolok was requested in Task Technical Request (TTR) HLW-DWPF-TTR-2010-0036 and was conducted as outlined in Task Technical and Quality Assurance Plan (TTQAP) SRNLRP-2011-00145. RW-0333P QA requirements applied to the task, and the results from the investigation were documented in SRNL-STI-2011-00693. Measurement of the chemical composition of study samples was a critical component of the SME acceptability testing of the Isolok. A sampling and analytical plan supported the investigation with the analytical plan directing that the study samples be prepared by a cesium carbonate (Cs{sub 2}CO{sub 3}) fusion dissolution method and analyzed by Inductively Coupled Plasma - Optical Emission Spectroscopy (ICP-OES). The use of the cesium carbonate preparation method for the Isolok testing provided an opportunity for an additional assessment of this dissolution method, which is being investigated as a potential replacement for the two methods (i.e., sodium peroxide fusion and mixed acid dissolution) that have been used at the DWPF for the analysis of SME samples. Earlier testing of the Cs{sub 2}CO{sub 3} method yielded promising results which led to a TTR from Savannah River Remediation, LLC (SRR) to SRNL for additional support and an associated TTQAP to direct the SRNL efforts. A technical report resulting from this work was issued that recommended that the mixed acid method be replaced by the Cs{sub 2}CO{sub 3} method for the measurement of magnesium (Mg), sodium (Na), and zirconium (Zr) with additional testing of the method by DWPF Laboratory being needed before further implementation of the Cs{sub 2}CO{sub 3} method at that laboratory. While the SME acceptability testing of the Isolok does not address any of the open issues remaining after the publication of the recommendation for the replacement of the mixed acid method by the Cs{sub 2}CO{sub 3} method (since those issues are to be addressed by the DWPF Laboratory), the Cs{sub 2}CO{sub 3} testing associated with the Isolok testing does provide additional insight into the performance of the method as conducted by SRNL. The performance is to be investigated by looking to the composition measurement data generated by the samples of a standard glass, the Analytical Reference Glass - 1 (ARG-1), that were prepared by the Cs{sub 2}CO{sub 3} method and included in the SME acceptability testing of the Isolok. The measurements of these samples were presented as part of the study results, but no statistical analysis of these measurements was conducted as part of those results. It is the purpose of this report to provide that analysis, which was supported using JMP Version 7.0.2.« less

A normalization method for combination of laboratory test results from different electronic healthcare databases in a distributed research network.

PubMed

Yoon, Dukyong; Schuemie, Martijn J; Kim, Ju Han; Kim, Dong Ki; Park, Man Young; Ahn, Eun Kyoung; Jung, Eun-Young; Park, Dong Kyun; Cho, Soo Yeon; Shin, Dahye; Hwang, Yeonsoo; Park, Rae Woong

2016-03-01

Distributed research networks (DRNs) afford statistical power by integrating observational data from multiple partners for retrospective studies. However, laboratory test results across care sites are derived using different assays from varying patient populations, making it difficult to simply combine data for analysis. Additionally, existing normalization methods are not suitable for retrospective studies. We normalized laboratory results from different data sources by adjusting for heterogeneous clinico-epidemiologic characteristics of the data and called this the subgroup-adjusted normalization (SAN) method. Subgroup-adjusted normalization renders the means and standard deviations of distributions identical under population structure-adjusted conditions. To evaluate its performance, we compared SAN with existing methods for simulated and real datasets consisting of blood urea nitrogen, serum creatinine, hematocrit, hemoglobin, serum potassium, and total bilirubin. Various clinico-epidemiologic characteristics can be applied together in SAN. For simplicity of comparison, age and gender were used to adjust population heterogeneity in this study. In simulations, SAN had the lowest standardized difference in means (SDM) and Kolmogorov-Smirnov values for all tests (p < 0.05). In a real dataset, SAN had the lowest SDM and Kolmogorov-Smirnov values for blood urea nitrogen, hematocrit, hemoglobin, and serum potassium, and the lowest SDM for serum creatinine (p < 0.05). Subgroup-adjusted normalization performed better than normalization using other methods. The SAN method is applicable in a DRN environment and should facilitate analysis of data integrated across DRN partners for retrospective observational studies. Copyright © 2015 John Wiley & Sons, Ltd.

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

Rodriguez, J.R.; Ahrens, J.S.; Lowe, D.L.

Throughout the years, Sandia National Laboratories (SNL) has performed various laboratory evaluations of entry control devices, including biometric identity verifiers. The reports which resulted from this testing have been very well received by the physical security community. This same community now requires equally informative field study data. To meet this need we have conducted a field study in an effort to develop the tools and methods which our customers can use to translate laboratory data into operational field performance. The field testing described in this report was based on the Recognition Systems Inc.`s (RSI) model ID3D HandKey biometric verifier. Thismore » device was selected because it is referenced in DOE documents such as the Guide for Implementation of the DOE Standard Badge and is the de facto biometric standard for the DOE. The ID3D HandKey is currently being used at several DOE sites such as Hanford, Rocky Flats, Pantex, Savannah River, and Idaho Nuclear Engineering Laboratory. The ID3D HandKey was laboratory tested at SNL. It performed very well during this test, exhibiting an equal error point of 0.2 percent. The goals of the field test were to identify operational characteristics and design guidelines to help system engineers translate laboratory data into field performance. A secondary goal was to develop tools which could be used by others to evaluate system effectiveness or improve the performance of their systems. Operational characteristics were determined by installing a working system and studying its operation over a five month period. Throughout this test we developed tools which could be used by others to similarly gauge system effectiveness.« less

Project development laboratories energy fuels and oils based on NRU “MPEI”

NASA Astrophysics Data System (ADS)

Burakov, I. A.; Burakov, A. Y.; Nikitina, I. S.; Khomenkov, A. M.; Paramonova, A. O.; Khtoo Naing, Aung

2017-11-01

In the process of improving the efficiency of power plants a hot topic is the use of high-quality fuels and lubricants. In the process of transportation, preparation for use, storage and maintenance of the properties of fuels and lubricants may deteriorate, which entails a reduction in the efficiency of power plants. One of the ways to prevent the deterioration of the properties is a timely analysis of the relevant laboratories. In this day, the existence of laboratories of energy fuels and energy laboratory oil at thermal power stations is satisfactory character. However, the training of qualified personnel to work in these laboratories is a serious problem, as the lack of opportunities in these laboratories a complete list of required tests. The solution to this problem is to explore the possibility of application of methods of analysis of the properties of fuels and lubricants in the stage of training and re-training of qualified personnel. In this regard, on the basis of MPEI developed laboratory projects of solid, liquid and gaseous fuels, power and energy oils and lubricants. Projects allow for a complete list of tests required for the timely control of properties and prevent the deterioration of these properties. Assess the financial component of the implementation of the developed projects based on the use of modern equipment used for tests. Projects allow for a complete list of tests required for the timely control of properties and prevent the deterioration of these properties.

Sigma metric analysis for performance of creatinine with fresh frozen serum.

PubMed

Kang, Fengfeng; Zhang, Chuanbao; Wang, Wei; Wang, Zhiguo

2016-01-01

Six sigma provides an objective and quantitative methodology to describe the laboratory testing performance. In this study, we conducted a national trueness verification scheme with fresh frozen serum (FFS) for serum creatinine to evaluate its performance in China. Two different concentration levels of FFS, targeted with reference method, were sent to 98 laboratories in China. Imprecision and bias of the measurement procedure were calculated for each participant to further evaluate the sigma value. Quality goal index (QGI) analysis was used to investigate the reason of unacceptable performance for laboratories with σ < 3. Our study indicated that the sample with high concentration of creatinine had preferable sigma values. For the enzymatic method, 7.0% (5/71) to 45.1% (32/71) of the laboratories need to improve their measurement procedures (σ < 3). And for the Jaffe method, the percentages were from 11.5% (3/26) to 73.1% (19/26). QGI analysis suggested that most of the laboratories (62.5% for the enzymatic method and 68.4% for the Jaffe method) should make an effort to improve the trueness (QGI > 1.2). Only 3.1-5.3% of the laboratories should improve both of the precision and trueness. Sigma metric analysis of the serum creatinine assays is disappointing, which was mainly due to the unacceptable analytical bias according to the QGI analysis. Further effort is needed to enhance the trueness of the creatinine measurement.

Evaluation of Targeted Next-Generation Sequencing for Detection of Bovine Pathogens in Clinical Samples.

PubMed

Anis, Eman; Hawkins, Ian K; Ilha, Marcia R S; Woldemeskel, Moges W; Saliki, Jeremiah T; Wilkes, Rebecca P

2018-07-01

The laboratory diagnosis of infectious diseases, especially those caused by mixed infections, is challenging. Routinely, it requires submission of multiple samples to separate laboratories. Advances in next-generation sequencing (NGS) have provided the opportunity for development of a comprehensive method to identify infectious agents. This study describes the use of target-specific primers for PCR-mediated amplification with the NGS technology in which pathogen genomic regions of interest are enriched and selectively sequenced from clinical samples. In the study, 198 primers were designed to target 43 common bovine and small-ruminant bacterial, fungal, viral, and parasitic pathogens, and a bioinformatics tool was specifically constructed for the detection of targeted pathogens. The primers were confirmed to detect the intended pathogens by testing reference strains and isolates. The method was then validated using 60 clinical samples (including tissues, feces, and milk) that were also tested with other routine diagnostic techniques. The detection limits of the targeted NGS method were evaluated using 10 representative pathogens that were also tested by quantitative PCR (qPCR), and the NGS method was able to detect the organisms from samples with qPCR threshold cycle ( C T ) values in the 30s. The method was successful for the detection of multiple pathogens in the clinical samples, including some additional pathogens missed by the routine techniques because the specific tests needed for the particular organisms were not performed. The results demonstrate the feasibility of the approach and indicate that it is possible to incorporate NGS as a diagnostic tool in a cost-effective manner into a veterinary diagnostic laboratory. Copyright © 2018 Anis et al.

Content of children's loss of control eating episodes assessed by self-report and laboratory test meal

PubMed Central

Theim, Kelly R.; Wilfley, Denise E.; Beach, Elizabeth; Tanofsky-Kraff, Marian; Goldschmidt, Andrea B.

2014-01-01

Pediatric loss of control (LOC) eating heightens risk for excessive weight gain and further disordered eating. Assessment of LOC typically involves self-report interview or laboratory test meal, although no study has concurrently examined data from both methods. We gathered eating episode data via interview (Child Eating Disorder Examination; ChEDE) and a laboratory test meal, among 22 overweight girls (aged 7-12 years) reporting LOC eating. Children consumed more energy during ChEDE episodes, although ChEDE and test meal episodes did not differ in macronutrient content. Episodes' correlation for amount consumed (grams) did not reach significance, p=.076. In exploratory analyses among the 7 children reporting LOC during the test meal, episodes were significantly correlated for grams consumed. Findings provide preliminary data to suggest that semi-structured interviews accurately capture children's LOC episode quantity. Episodes did not qualitatively differ, although children reported consuming more energy during self-reported episodes. Replication is warranted in larger studies. PMID:24019221

NREL and SDG&E Collaboration to Support SDG&E Grid and Storage Efforts: Cooperative Research and Development Final Report, CRADA Number CRD-14-562

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

Baggu, Murali

2017-01-01

This project will enable effective utilization of high penetration of photovoltaics (PV) in islanded microgrids, increasing overall system efficiency, decreased fuel costs and resiliency of the overall system to help meet the SunShot goals of enhancing system integration methods to increase penetration of PV. National Renewable Energy Laboratory (NREL) will collaborate with San Diego Gas & Electric (SDG&E) to provide research and testing support to address their needs in energy storage sizing and placement, Integrated Test Facility (ITF) development, Real Time Digital Simulator (RTDS) Modeling and simulation support at ITF, Visualization and Virtual connection to Energy Systems Integration Facility (ESIF),more » and microgrid simulation and testing areas. Specifically in this project a real microgrid scenario with high penetration of PV (existing in SDG&E territory) is tested in the ESIF laboratory. Multiple control cases for firming PV using storage in a microgrid scenario will be investigated and tested in the laboratory setup.« less

Evaluation of Performance of Laboratories and Manufacturers Within the Framework of the IFCC model for Quality Targets of HbA1c.

PubMed

Weykamp, Cas; Siebelder, Carla

2017-11-01

HbA1c is a key parameter in diabetes management. For years the test has been used exclusively for monitoring of long-term diabetic control. However, due to improvement of the performance, HbA1c is considered more and more for diagnosis and screening. With this new application, quality demands further increase. A task force of the International Federation of Clinical Chemistry and Laboratory Medicine developed a model to set and evaluate quality targets for HbA1c. The model is based on the concept of total error and takes into account the major sources of analytical errors in the medical laboratory: bias and imprecision. Performance criteria are derived from sigma-metrics and biological variation. This review shows 2 examples of the application of the model: at the level of single laboratories, and at the level of a group of laboratories. In the first example data of 125 individual laboratories of a recent external quality assessment program in the Netherlands are evaluated. Differences between laboratories as well as their relation to method principles are shown. The second example uses recent and 3-year-old data of the proficiency test of the College of American Pathologists. The differences in performance between 26 manufacturer-related groups of laboratories are shown. Over time these differences are quite consistent although some manufacturers improved substantially either by better standardization or by replacing a test. The IFCC model serves all who are involved in HbA1c testing in the ongoing process of better performance and better patient care.