[Serological screening for Trypanosoma cruzi among blood donors in central Brazil].

PubMed

de Andrade, A L; Martelli, C M; Luquetti, A O; de Oliveira, O S; Almeida e Silva, S; Zicker, F

1992-07-01

The present study compares the results of serological screening for Trypanosoma cruzi infection done at blood banks with results obtained in Chagas' disease studies undertaken by the Reference Laboratory of the Federal University of Goiás (UFG) and evaluates the use of the enzyme-linked immunosorbent assay (ELISA) for this purpose. The study was conducted with data from six of the eight blood banks in the city of Goiânia in central Brazil, an urban area in which this infection is highly endemic. The population studied consisted of 1,513 volunteers who had donated blood for the first time between October 1988 and April 1989. The sample represented 50% of all first-time blood donors during the period. Of these donors, 94% were residents of urban areas, and of these, approximately 26% had migrated from the countryside. Nearly 90% of the blood donations in the city are received at these banks, which normally use the indirect hemagglutination and complement-fixation tests. The samples selected for the study of T. cruzi antibody in first-time blood donors were assayed at the Reference Laboratory of the Federal University of Goiás using the indirect hemagglutination (IH), indirect immunofluorescence (IF), and enzyme-linked immunosorbent assay (ELISA) tests, independently of the serological classification performed by the blood banks. Comparison of the results provided by the latter with the positivity pattern established in the study (IH and IF yielded simultaneous positive results in the Reference Laboratory) revealed a relative sensitivity of 77%, with extremes ranging between 50% and 100%, depending on the blood bank studied.(ABSTRACT TRUNCATED AT 250 WORDS)

Measuring the glycemic index of foods: interlaboratory study.

PubMed

Wolever, Thomas M S; Brand-Miller, Jennie C; Abernethy, John; Astrup, Arne; Atkinson, Fiona; Axelsen, Mette; Björck, Inger; Brighenti, Furio; Brown, Rachel; Brynes, Audrey; Casiraghi, M Cristina; Cazaubiel, Murielle; Dahlqvist, Linda; Delport, Elizabeth; Denyer, Gareth S; Erba, Daniela; Frost, Gary; Granfeldt, Yvonne; Hampton, Shelagh; Hart, Valerie A; Hätönen, Katja A; Henry, C Jeya; Hertzler, Steve; Hull, Sarah; Jerling, Johann; Johnston, Kelly L; Lightowler, Helen; Mann, Neil; Morgan, Linda; Panlasigui, Leonora N; Pelkman, Christine; Perry, Tracy; Pfeiffer, Andreas F H; Pieters, Marlien; Ramdath, D Dan; Ramsingh, Rayna T; Robert, S Daniel; Robinson, Carol; Sarkkinen, Essi; Scazzina, Francesca; Sison, Dave Clark D; Sloth, Birgitte; Staniforth, Jane; Tapola, Niina; Valsta, Liisa M; Verkooijen, Inge; Weickert, Martin O; Weseler, Antje R; Wilkie, Paul; Zhang, Jian

2008-01-01

Many laboratories offer glycemic index (GI) services. We assessed the performance of the method used to measure GI. The GI of cheese-puffs and fruit-leather (centrally provided) was measured in 28 laboratories (n=311 subjects) by using the FAO/WHO method. The laboratories reported the results of their calculations and sent the raw data for recalculation centrally. Values for the incremental area under the curve (AUC) reported by 54% of the laboratories differed from central calculations. Because of this and other differences in data analysis, 19% of reported food GI values differed by >5 units from those calculated centrally. GI values in individual subjects were unrelated to age, sex, ethnicity, body mass index, or AUC but were negatively related to within-individual variation (P=0.033) expressed as the CV of the AUC for repeated reference food tests (refCV). The between-laboratory GI values (mean+/-SD) for cheese-puffs and fruit-leather were 74.3+/-10.5 and 33.2+/-7.2, respectively. The mean laboratory GI was related to refCV (P=0.003) and the type of restrictions on alcohol consumption before the test (P=0.006, r2=0.509 for model). The within-laboratory SD of GI was related to refCV (P<0.001), the glucose analysis method (P=0.010), whether glucose measures were duplicated (P=0.008), and restrictions on dinner the night before (P=0.013, r2=0.810 for model). The between-laboratory SD of the GI values is approximately 9. Standardized data analysis and low within-subject variation (refCV<30%) are required for accuracy. The results suggest that common misconceptions exist about which factors do and do not need to be controlled to improve precision. Controlled studies and cost-benefit analyses are needed to optimize GI methodology. The trial was registered at clinicaltrials.gov as NCT00260858.

Field Identification of Andic Soil Properties for Soils of North-central Idaho

Treesearch

Brian Gardner

2007-01-01

Currently, laboratory measurements are definitive for identifying andic soil properties in both the USDA Soil Taxonomy (Soil Survey Staff 1999) and the World Reference Base for Soil Resources (FAO/ISRIC/ISSS 1998). Andic soil properties, as described in Soil Taxonomy, result mainly from the presence of significant amounts of allophone, imogolite, ferrihydrite or...

[Analysis of productivity, quality and cost of first grade laboratories: blood biometry].

PubMed

Avila, L; Hernández, P; Cruz, A; Zurita, B; Terres, A M; Cruz, C

1999-04-01

Assessment of productivity, quality and production costs and determination of the efficiency of top grade clinical laboratories in Mexico. Ten laboratories were selected from among the total number (52) existing in Mexico City, and the Donabedian model of structure, process and results were applied. Blood count was selected as a tracer. The principal problems found were: inadequate distribution of trained human resources, poor glass material, inadequate analytic process and low productivity. These factors are reflected in the unit costs, which exceed reference laboratory costs by 200%. Only 50% of the laboratories analyzed generate reliable results. Only 20% of the laboratories studied operate efficiently. To solve the problems identified requires integral strategies at different levels. A specific recomendation for the improvement of quality and productivity is an assessment of the cost/benefit of creating a central laboratory and using the remaining sites exclusively for the collection of samples.

Implementation of a reference standard and proficiency testing programme by the World Wide Antimalarial Resistance Network (WWARN)

PubMed Central

2010-01-01

Background The Worldwide Antimalarial Resistance Network (WWARN) is a global collaboration to support the objective that anyone affected by malaria receives effective and safe drug treatment. The Pharmacology module aims to inform optimal anti-malarial drug selection. There is an urgent need to define the drug exposure - effect relationship for most anti-malarial drugs. Few anti-malarials have had their therapeutic blood concentration levels defined. One of the main challenges in assessing safety and efficacy data in relation to drug concentrations is the comparability of data generated from different laboratories. To explain differences in anti-malarial pharmacokinetics in studies with different measurement laboratories it is necessary to confirm the accuracy of the assay methods. This requires the establishment of an external quality assurance process to assure results that can be compared. This paper describes this process. Methods The pharmacology module of WWARN has established a quality assurance/quality control (QA/QC) programme consisting of two separate components: 1. A proficiency testing programme where blank human plasma spiked with certified reference material (CRM) in different concentrations is sent out to participating bioanalytical laboratories. 2. A certified reference standard programme where accurately weighed amounts of certified anti-malarial reference standards, metabolites, and internal standards are sent to participating bioanalytical and in vitro laboratories. Conclusion The proficiency testing programme is designed as a cooperative effort to help participating laboratories assess their ability to carry out drug analysis, resolve any potential problem areas and to improve their results - and, in so doing, to improve the quality of anti-malarial pharmacokinetic data published and shared with WWARN. By utilizing the same source of standards for all laboratories, it is possible to minimize bias arising from poor quality reference standards. By providing anti-malarial drug standards from a central point, it is possible to lower the cost of these standards. PMID:21184684

Multiplex real-time quantitative PCR, microscopy and rapid diagnostic immuno-chromatographic tests for the detection of Plasmodium spp: performance, limit of detection analysis and quality assurance.

PubMed

Khairnar, Krishna; Martin, Donald; Lau, Rachel; Ralevski, Filip; Pillai, Dylan R

2009-12-09

Accurate laboratory diagnosis of malaria species in returning travelers is paramount in the treatment of this potentially fatal infectious disease. A total of 466 blood specimens from returning travelers to Africa, Asia, and South/Central America with suspected malaria infection were collected between 2007 and 2009 at the reference public health laboratory. These specimens were assessed by reference microscopy, multipex real-time quantitative polymerase chain reaction (QPCR), and two rapid diagnostic immuno-chromatographic tests (ICT) in a blinded manner. Key clinical laboratory parameters such as limit of detection (LOD) analysis on clinical specimens by parasite stage, inter-reader variability of ICTs, staffing implications, quality assurance and cost analysis were evaluated. QPCR is the most analytically sensitive method (sensitivity 99.41%), followed by CARESTART (sensitivity 88.24%), and BINAXNOW (sensitivity 86.47%) for the diagnosis of malaria in returning travelers when compared to reference microscopy. However, microscopy was unable to specifically identify Plasmodia spp. in 18 out of 170 positive samples by QPCR. Moreover, the 17 samples that were negative by microscopy and positive by QPCR were also positive by ICTs. Quality assurance was achieved for QPCR by exchanging a blinded proficiency panel with another reference laboratory. The Kappa value of inter-reader variability among three readers for BINAXNOW and CARESTART was calculated to be 0.872 and 0.898 respectively. Serial dilution studies demonstrated that the QPCR cycle threshold correlates linearly with parasitemia (R(2) = 0.9746) in a clinically relevant dynamic range and retains a LOD of 11 rDNA copies/microl for P. falciparum, which was several log lower than reference microscopy and ICTs. LOD for QPCR is affected not only by parasitemia but the parasite stage distribution of each clinical specimen. QPCR was approximately 6-fold more costly than reference microscopy. These data suggest that multiplex QPCR although more costly confers a significant diagnostic advantage in terms of LOD compared to reference microscopy and ICTs for all four species. Quality assurance of QPCR is essential to the maintenance of proficiency in the clinical laboratory. ICTs showed good concordance between readers however lacked sensitivity for non-falciparum species due to antigenic differences and low parasitemia. Multiplex QPCR but not ICTs is an essential adjunct to microscopy in the reference laboratory detection of malaria species specifically due to the superior LOD. ICTs are better suited to the non-reference laboratory where lower specimen volumes challenge microscopy proficiency in the non-endemic setting.

Harmonizing lipidomics: NIST interlaboratory comparison exercise for lipidomics using SRM 1950-Metabolites in Frozen Human Plasma.

PubMed

Bowden, John A; Heckert, Alan; Ulmer, Candice Z; Jones, Christina M; Koelmel, Jeremy P; Abdullah, Laila; Ahonen, Linda; Alnouti, Yazen; Armando, Aaron M; Asara, John M; Bamba, Takeshi; Barr, John R; Bergquist, Jonas; Borchers, Christoph H; Brandsma, Joost; Breitkopf, Susanne B; Cajka, Tomas; Cazenave-Gassiot, Amaury; Checa, Antonio; Cinel, Michelle A; Colas, Romain A; Cremers, Serge; Dennis, Edward A; Evans, James E; Fauland, Alexander; Fiehn, Oliver; Gardner, Michael S; Garrett, Timothy J; Gotlinger, Katherine H; Han, Jun; Huang, Yingying; Neo, Aveline Huipeng; Hyötyläinen, Tuulia; Izumi, Yoshihiro; Jiang, Hongfeng; Jiang, Houli; Jiang, Jiang; Kachman, Maureen; Kiyonami, Reiko; Klavins, Kristaps; Klose, Christian; Köfeler, Harald C; Kolmert, Johan; Koal, Therese; Koster, Grielof; Kuklenyik, Zsuzsanna; Kurland, Irwin J; Leadley, Michael; Lin, Karen; Maddipati, Krishna Rao; McDougall, Danielle; Meikle, Peter J; Mellett, Natalie A; Monnin, Cian; Moseley, M Arthur; Nandakumar, Renu; Oresic, Matej; Patterson, Rainey; Peake, David; Pierce, Jason S; Post, Martin; Postle, Anthony D; Pugh, Rebecca; Qiu, Yunping; Quehenberger, Oswald; Ramrup, Parsram; Rees, Jon; Rembiesa, Barbara; Reynaud, Denis; Roth, Mary R; Sales, Susanne; Schuhmann, Kai; Schwartzman, Michal Laniado; Serhan, Charles N; Shevchenko, Andrej; Somerville, Stephen E; St John-Williams, Lisa; Surma, Michal A; Takeda, Hiroaki; Thakare, Rhishikesh; Thompson, J Will; Torta, Federico; Triebl, Alexander; Trötzmüller, Martin; Ubhayasekera, S J Kumari; Vuckovic, Dajana; Weir, Jacquelyn M; Welti, Ruth; Wenk, Markus R; Wheelock, Craig E; Yao, Libin; Yuan, Min; Zhao, Xueqing Heather; Zhou, Senlin

2017-12-01

As the lipidomics field continues to advance, self-evaluation within the community is critical. Here, we performed an interlaboratory comparison exercise for lipidomics using Standard Reference Material (SRM) 1950-Metabolites in Frozen Human Plasma, a commercially available reference material. The interlaboratory study comprised 31 diverse laboratories, with each laboratory using a different lipidomics workflow. A total of 1,527 unique lipids were measured across all laboratories and consensus location estimates and associated uncertainties were determined for 339 of these lipids measured at the sum composition level by five or more participating laboratories. These evaluated lipids detected in SRM 1950 serve as community-wide benchmarks for intra- and interlaboratory quality control and method validation. These analyses were performed using nonstandardized laboratory-independent workflows. The consensus locations were also compared with a previous examination of SRM 1950 by the LIPID MAPS consortium. While the central theme of the interlaboratory study was to provide values to help harmonize lipids, lipid mediators, and precursor measurements across the community, it was also initiated to stimulate a discussion regarding areas in need of improvement. Copyright © 2017 by the American Society for Biochemistry and Molecular Biology, Inc.

Comparison of plasma ammonia results from seven different automated platforms in use throughout Central Australia.

PubMed

Markus, Corey; Metz, Michael

2017-04-01

The clinical catchment area for the Metabolic service at the Women's and Children's Hospital in Adelaide, South Australia, covers nearly 2.5millionkm 2 . Care of children with metabolic disorders in these remote areas is assisted from Adelaide, and at times, using plasma ammonia results from laboratories up to 3000km away. There are seven different platforms measuring plasma ammonia within this vast clinical catchment area. Hence, a correlation study was conducted to examine the relationship between plasma ammonia results from the seven different platforms in use throughout central Australia. Multiple aliquots of plasma from remainder EDTA samples for haematological investigations were frozen. Samples were then dispatched on dry ice to the laboratories being correlated. At an agreed date and time correlation samples were thawed and plasma ammonia measured. Passing-Bablok regression analysis showed slopes ranging from 1.00 to 1.10 and y-intercepts ranging from -10μmol/L to 1μmol/L. Despite the absence of a reference method or reference material and troublesome pre-analytical effects in ammonia measurement, plasma ammonia results from the different platforms in general compare well. The study also demonstrates that samples for ammonia measurement can be transported over great distances and still correlate well. Furthermore, a common reference interval for plasma ammonia may be a possibility. Crown Copyright © 2016. Published by Elsevier Inc. All rights reserved.

Standardization of Laboratory Methods for the PERCH Study

PubMed Central

Karron, Ruth A.; Morpeth, Susan C.; Bhat, Niranjan; Levine, Orin S.; Baggett, Henry C.; Brooks, W. Abdullah; Feikin, Daniel R.; Hammitt, Laura L.; Howie, Stephen R. C.; Knoll, Maria Deloria; Kotloff, Karen L.; Madhi, Shabir A.; Scott, J. Anthony G.; Thea, Donald M.; Adrian, Peter V.; Ahmed, Dilruba; Alam, Muntasir; Anderson, Trevor P.; Antonio, Martin; Baillie, Vicky L.; Dione, Michel; Endtz, Hubert P.; Gitahi, Caroline; Karani, Angela; Kwenda, Geoffrey; Maiga, Abdoul Aziz; McClellan, Jessica; Mitchell, Joanne L.; Morailane, Palesa; Mugo, Daisy; Mwaba, John; Mwansa, James; Mwarumba, Salim; Nyongesa, Sammy; Panchalingam, Sandra; Rahman, Mustafizur; Sawatwong, Pongpun; Tamboura, Boubou; Toure, Aliou; Whistler, Toni; O’Brien, Katherine L.; Murdoch, David R.

2017-01-01

Abstract The Pneumonia Etiology Research for Child Health study was conducted across 7 diverse research sites and relied on standardized clinical and laboratory methods for the accurate and meaningful interpretation of pneumonia etiology data. Blood, respiratory specimens, and urine were collected from children aged 1–59 months hospitalized with severe or very severe pneumonia and community controls of the same age without severe pneumonia and were tested with an extensive array of laboratory diagnostic tests. A standardized testing algorithm and standard operating procedures were applied across all study sites. Site laboratories received uniform training, equipment, and reagents for core testing methods. Standardization was further assured by routine teleconferences, in-person meetings, site monitoring visits, and internal and external quality assurance testing. Targeted confirmatory testing and testing by specialized assays were done at a central reference laboratory. PMID:28575358

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

Reference Intervals of Common Clinical Chemistry Analytes for Adults in Hong Kong.

PubMed

Lo, Y C; Armbruster, David A

2012-04-01

Defining reference intervals is a major challenge because of the difficulty in recruiting volunteers to participate and testing samples from a significant number of healthy reference individuals. Historical literature citation intervals are often suboptimal because they're be based on obsolete methods and/or only a small number of poorly defined reference samples. Blood donors in Hong Kong gave permission for additional blood to be collected for reference interval testing. The samples were tested for twenty-five routine analytes on the Abbott ARCHITECT clinical chemistry system. Results were analyzed using the Rhoads EP evaluator software program, which is based on the CLSI/IFCC C28-A guideline, and defines the reference interval as the 95% central range. Method specific reference intervals were established for twenty-five common clinical chemistry analytes for a Chinese ethnic population. The intervals were defined for each gender separately and for genders combined. Gender specific or combined gender intervals were adapted as appropriate for each analyte. A large number of healthy, apparently normal blood donors from a local ethnic population were tested to provide current reference intervals for a new clinical chemistry system. Intervals were determined following an accepted international guideline. Laboratories using the same or similar methodologies may adapt these intervals if deemed validated and deemed suitable for their patient population. Laboratories using different methodologies may be able to successfully adapt the intervals for their facilities using the reference interval transference technique based on a method comparison study.

Laboratory Surge Response to Pandemic (H1N1) 2009 Outbreak, New York City Metropolitan Area, USA

PubMed Central

Crawford, James M.; Stallone, Robert; Zhang, Fan; Gerolimatos, Mary; Korologos, Diamanto D.; Sweetapple, Carolyn; de Geronimo, Marcella; Dlugacz, Yosef; Armellino, Donna M.

2010-01-01

The North Shore–Long Island Jewish Health System Laboratories serve 15 hospitals and affiliated regional physician practices in the New York City metropolitan area, with virus testing performed at a central reference laboratory. The influenza A pandemic (H1N1) 2009 outbreak began in this area on April 24, 2009, and within weeks respiratory virus testing increased 7.5 times. In response, laboratory and client service workforces were increased, physical plant build-out was completed, testing paradigms were converted from routine screening tests and viral culture to a high-capacity molecular assay for respiratory viruses, laboratory information system interfaces were built, and same-day epidemiologic reports were produced. Daily review by leadership of data from emergency rooms, hospital facilities, and the Health System Laboratories enabled real-time management of unfolding events. The ability of System laboratories to rapidly increase to high-volume comprehensive diagnostics, including influenza A subtyping, provided key epidemiologic information for local and state public health departments. PMID:20031036

Laboratory surge response to pandemic (H1N1) 2009 outbreak, New York City metropolitan area, USA.

PubMed

Crawford, James M; Stallone, Robert; Zhang, Fan; Gerolimatos, Mary; Korologos, Diamanto D; Sweetapple, Carolyn; de Geronimo, Marcella; Dlugacz, Yosef; Armellino, Donna M; Ginocchio, Christine C

2010-01-01

The North Shore-Long Island Jewish Health System Laboratories serve 15 hospitals and affiliated regional physician practices in the New York City metropolitan area, with virus testing performed at a central reference laboratory. The influenza A pandemic (H1N1) 2009 outbreak began in this area on April 24, 2009, and within weeks respiratory virus testing increased 7.5 times. In response, laboratory and client service workforces were increased, physical plant build-out was completed, testing paradigms were converted from routine screening tests and viral culture to a high-capacity molecular assay for respiratory viruses, laboratory information system interfaces were built, and same-day epidemiologic reports were produced. Daily review by leadership of data from emergency rooms, hospital facilities, and the Health System Laboratories enabled real-time management of unfolding events. The ability of System laboratories to rapidly increase to high-volume comprehensive diagnostics, including influenza A subtyping, provided key epidemiologic information for local and state public health departments.

Working toward a sustainable laboratory quality improvement programme through country ownership: Mozambique's SLMTA story.

PubMed

Masamha, Jessina; Skaggs, Beth; Pinto, Isabel; Mandlaze, Ana Paula; Simbine, Carolina; Chongo, Patrina; de Sousa, Leonardo; Kidane, Solon; Yao, Katy; Luman, Elizabeth T; Samogudo, Eduardo

2014-01-01

Launched in 2009, the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme has emerged as an innovative approach for the improvement of laboratory quality. In order to ensure sustainability, Mozambique embedded the SLMTA programme within the existing Ministry of Health (MOH) laboratory structure. This article outlines the steps followed to establish a national framework for quality improvement and embedding the SLMTA programme within existing MOH laboratory systems. The MOH adopted SLMTA as the national laboratory quality improvement strategy, hired a dedicated coordinator and established a national laboratory quality technical working group comprising mostly personnel from key MOH departments. The working group developed an implementation framework for advocacy, training, mentorship, supervision and audits. Emphasis was placed on building local capacity for programme activities. After receiving training, a team of 25 implementers (18 from the MOH and seven from partner organisations) conducted baseline audits (using the Stepwise Laboratory Quality Improvement Process Towards Accreditation [SLIPTA] checklist), workshops and site visits in six reference and two central hospital laboratories. Exit audits were conducted in six of the eight laboratories and their results are presented. The six laboratories demonstrated substantial improvement in audit scores; median scores increased from 35% at baseline to 57% at exit. It has been recommended that the National Tuberculosis Reference Laboratory apply for international accreditation. Successful implementation of SLMTA requires partnership between programme implementers, whilst effectiveness and long-term viability depend on country leadership, ownership and commitment. Integration of SLMTA into the existing MOH laboratory system will ensure durability beyond initial investments. The Mozambican model holds great promise that country leadership, ownership and institutionalisation can set the stage for programme success and sustainability.

Nationwide Multicenter Reference Interval Study for 28 Common Biochemical Analytes in China.

PubMed

Xia, Liangyu; Chen, Ming; Liu, Min; Tao, Zhihua; Li, Shijun; Wang, Liang; Cheng, Xinqi; Qin, Xuzhen; Han, Jianhua; Li, Pengchang; Hou, Li'an; Yu, Songlin; Ichihara, Kiyoshi; Qiu, Ling

2016-03-01

A nationwide multicenter study was conducted in the China to explore sources of variation of reference values and establish reference intervals for 28 common biochemical analytes, as a part of the International Federation of Clinical Chemistry and Laboratory Medicine, Committee on Reference Intervals and Decision Limits (IFCC/C-RIDL) global study on reference values. A total of 3148 apparently healthy volunteers were recruited in 6 cities covering a wide area in China. Blood samples were tested in 2 central laboratories using Beckman Coulter AU5800 chemistry analyzers. Certified reference materials and value-assigned serum panel were used for standardization of test results. Multiple regression analysis was performed to explore sources of variation. Need for partition of reference intervals was evaluated based on 3-level nested ANOVA. After secondary exclusion using the latent abnormal values exclusion method, reference intervals were derived by a parametric method using the modified Box-Cox formula. Test results of 20 analytes were made traceable to reference measurement procedures. By the ANOVA, significant sex-related and age-related differences were observed in 12 and 12 analytes, respectively. A small regional difference was observed in the results for albumin, glucose, and sodium. Multiple regression analysis revealed BMI-related changes in results of 9 analytes for man and 6 for woman. Reference intervals of 28 analytes were computed with 17 analytes partitioned by sex and/or age. In conclusion, reference intervals of 28 common chemistry analytes applicable to Chinese Han population were established by use of the latest methodology. Reference intervals of 20 analytes traceable to reference measurement procedures can be used as common reference intervals, whereas others can be used as the assay system-specific reference intervals in China.

Nationwide Multicenter Reference Interval Study for 28 Common Biochemical Analytes in China

PubMed Central

Xia, Liangyu; Chen, Ming; Liu, Min; Tao, Zhihua; Li, Shijun; Wang, Liang; Cheng, Xinqi; Qin, Xuzhen; Han, Jianhua; Li, Pengchang; Hou, Li’an; Yu, Songlin; Ichihara, Kiyoshi; Qiu, Ling

2016-01-01

Abstract A nationwide multicenter study was conducted in the China to explore sources of variation of reference values and establish reference intervals for 28 common biochemical analytes, as a part of the International Federation of Clinical Chemistry and Laboratory Medicine, Committee on Reference Intervals and Decision Limits (IFCC/C-RIDL) global study on reference values. A total of 3148 apparently healthy volunteers were recruited in 6 cities covering a wide area in China. Blood samples were tested in 2 central laboratories using Beckman Coulter AU5800 chemistry analyzers. Certified reference materials and value-assigned serum panel were used for standardization of test results. Multiple regression analysis was performed to explore sources of variation. Need for partition of reference intervals was evaluated based on 3-level nested ANOVA. After secondary exclusion using the latent abnormal values exclusion method, reference intervals were derived by a parametric method using the modified Box–Cox formula. Test results of 20 analytes were made traceable to reference measurement procedures. By the ANOVA, significant sex-related and age-related differences were observed in 12 and 12 analytes, respectively. A small regional difference was observed in the results for albumin, glucose, and sodium. Multiple regression analysis revealed BMI-related changes in results of 9 analytes for man and 6 for woman. Reference intervals of 28 analytes were computed with 17 analytes partitioned by sex and/or age. In conclusion, reference intervals of 28 common chemistry analytes applicable to Chinese Han population were established by use of the latest methodology. Reference intervals of 20 analytes traceable to reference measurement procedures can be used as common reference intervals, whereas others can be used as the assay system-specific reference intervals in China. PMID:26945390

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

PubMed

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

2013-07-01

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

Spot protein-creatinine ratio and spot albumin-creatinine ratio in the assessment of pre-eclampsia: a diagnostic accuracy study with decision-analytic model-based economic evaluation and acceptability analysis.

PubMed

Waugh, Jason; Hooper, Richard; Lamb, Edmund; Robson, Stephen; Shennan, Andrew; Milne, Fiona; Price, Christopher; Thangaratinam, Shakila; Berdunov, Vladislav; Bingham, Jenn

2017-10-01

The National Institute for Health and Care Excellence (NICE) guidelines highlighted the need for 'large, high-quality prospective studies comparing the various methods of measuring proteinuria in women with new-onset hypertensive disorders during pregnancy'. The primary objective was to evaluate quantitative assessments of spot protein-creatinine ratio (SPCR) and spot albumin-creatinine ratio (SACR) in predicting severe pre-eclampsia (PE) compared with 24-hour urine protein measurement. The secondary objectives were to investigate interlaboratory assay variation, to evaluate SPCR and SACR thresholds in predicting adverse maternal and fetal outcomes and to assess the cost-effectiveness of these models. This was a prospective diagnostic accuracy cohort study, with decision-analytic modelling and a cost-effectiveness analysis. The setting was 36 obstetric units in England, UK. Pregnant women (aged ≥ 16 years), who were at > 20 weeks' gestation with confirmed gestational hypertension and trace or more proteinuria on an automated dipstick urinalysis. Women provided a spot urine sample for protein analysis (the recruitment sample) and were asked to collect a 24-hour urine sample, which was stored for secondary analysis. A further spot sample of urine was taken immediately before delivery. Outcome data were collected from hospital records. There were four index tests on a spot sample of urine: (1) SPCR test (conducted at the local laboratory); (2) SPCR test [conducted at the central laboratory using the benzethonium chloride (BZC) assay]; (3) SPCR test [conducted at the central laboratory using the pyrogallol red (PGR) assay]; and (4) SACR test (conducted at the central laboratory using an automated chemistry analyser). The comparator tests on 24-hour urine collection were a central test using the BZC assay and a central test using the PGR assay. The primary reference standard was the NICE definition of severe PE. Secondary reference standards were a clinician diagnosis of severe PE, which is defined as treatment with magnesium sulphate or with severe PE protocol; adverse perinatal outcome; one or more of perinatal or infant mortality, bronchopulmonary dysplasia, necrotising enterocolitis or grade III/IV intraventricular haemorrhage; and economic cost and outcomes. Health service data on service use and costs followed published economic models. In total, 959 women were available for primary analysis and 417 of them had severe PE. The diagnostic accuracy of the four assays on spot urine samples against the reference standards was similar. The three SPCR tests had sensitivities in excess of 90% at prespecified thresholds, with poor specificities and negative likelihood ratios of ≥ 0.1. The SACR test had a significantly higher sensitivity of 99% (confidence interval 98% to 100%) and lower specificity. Receiver operating characteristic (ROC) curves were similar (area under ROC curve between 0.87 and 0.89); the area under the central laboratory's SACR curve was significantly higher ( p  = 0.004). The central laboratory's SACR test was the most cost-effective option, generating an additional 0.03 quality-adjusted life-years at an additional cost of £45.07 compared with the local laboratory's SPCR test. The probabilistic analysis showed it to have a 100% probability of being cost-effective at the standard willingness-to-pay threshold recommended by NICE. Implementation of NICE guidelines has led to an increased intervention rate in the study population that affected recruitment rates and led to revised sample size calculations. Evidence from this clinical study does not support the recommendation of 24-hour urine sample collection in hypertensive pregnant women. The SACR test had better diagnostic performance when predicting severe pre-eclampsia. All four tests could potentially be used as rule-out tests for the NICE definition of severe PE. Testing SACR at a threshold of 8 mg/mmol should be studied as a 'rule-out' test of proteinuria. Current Controlled Trials ISRCTN82607486. This project was funded by the National Institute Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 21, No. 61. See the NIHR Journals Library website for further project information.

Adventures in Laser Produced Plasma Research

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

Key, M

2006-01-13

In the UK the study of laser produced plasmas and their applications began in the universities and evolved to a current system where the research is mainly carried out at the Rutherford Appleton Laboratory Central Laser Facility ( CLF) which is provided to support the universities. My own research work has been closely tied to this evolution and in this review I describe the history with particular reference to my participation in it.

Towards the distribution network of time and frequency

NASA Astrophysics Data System (ADS)

Lipiński, M.; Krehlik, P.; Śliwczyński, Ł.; Buczek, Ł.; Kołodziej, J.; Nawrocki, J.; Nogaś, P.; Dunst, P.; Lemański, D.; Czubla, A.; Pieczerak, J.; Adamowicz, W.; Pawszak, T.; Igalson, J.; Binczewski, A.; Bogacki, W.; Ostapowicz, P.; Stroiński, M.; Turza, K.

2014-05-01

In the paper the genesis, current stage and perspectives of the OPTIME project are described. The main goal of the project is to demonstrate that the newdeveloped at AGH technology of fiber optic transfer of the atomic clocks reference signals is ready to be used in building the domestic Time and Frequency distribution network. In the first part we summarize the two-year continuous operation of 420 kmlong link connecting the Laboratory of Time and Frequency at Central Office of Measures GUM in Warsaw and Time Service Laboratory at Astrogeodynamic Obserwatory AOS in Borowiec near Poznan. For the first time, we are reporting the two year comparison of UTC(PL) and UTC(AOS) atomic timescales with this link, and we refer it to the results of comparisons performed by GPS-based methods. We also address some practical aspects of maintaining time and frequency dissemination over fiber optical network. In the second part of the paper the concept of the general architecture of the distribution network with two Reference Time and Frequency Laboratories and local repositories is proposed. Moreover the brief project of the second branch connecting repositories in Poznan Polish Supercomputing and Networking Center and Torun Nicolaus Copernicus University with the first end-users in Torun such as National Laboratory of Atomic, Molecular and Optical Physics and Nicolaus Copernicus Astronomical Center is described. In the final part the perspective of developing the network both in the domestic range as far as extention with the international connections possibilities are presented.

[Inter-laboratory reproducibility of pulsed-field electrophoresis for the study of 12 types of Pseudomonas aeruginosa].

PubMed

Foissaud, V; Puyhardy, J M; Chapalain, J C; Salord, H; Depina, J J; Morillon, M; Nicolas, P; Perrier-Gros-Claude, J D

1999-12-01

The increasing hospital-to-hospital transmission of multiple drug-resistant bacteria is a major concern for bacteriology laboratories involved in nosocomial infection control. The interlaboratory reproducibility of pulsed-field gel electrophoresis (PFGE) for Pseudomonas aeruginosa typing was evaluated by asking four hospital laboratories (two in Lyon, one in Brest, and one in Marseille) to study 11 P. aeruginosa isolates, some of which were epidemiologically related, and the reference strain ATCC 27853. Two laboratories used the Genepath system, one the Chef DR II, system, and one the Chef Mapper system, Bio-Rad, restriction/Spe I. Profiles were read visually and by computerized comparison of restriction band molecular weights (Taxotron, software, PAD Grimont, Pasteur Institute, Paris, France). These two methods led to similar epidemiological conclusions. However, centralization of the data showed poor center-to-center reproducibility due to inadequate standardization of the procedure.

Performance of Paracheck™-Pf, SD Bioline malaria Ag-Pf and SD Bioline malaria Ag-Pf/pan for diagnosis of falciparum malaria in the Central African Republic

PubMed Central

2014-01-01

Background Rapid diagnostic tests (RDTs) are the current complement to microscopy for ensuring prompt malaria treatment. We determined the performance of three candidate RDTs (Paracheck™-Pf, SD Bioline malaria Ag-Pf and SD Bioline malaria Ag-Pf/pan) for rapid diagnosis of malaria in the Central African Republic. Methods Blood samples from consecutive febrile patients who attended for laboratory analysis of malaria at the three main health centres of Bangui were screened by microscopy and the RDTs. Two reference standards were used to assess the performance of the RDTs: microscopy and, a combination of microscopy plus nested PCR for slides reported as negative, on the assumption that negative results by microscopy were due to sub-patent parasitaemia. Results We analysed 436 samples. Using the combined reference standard of microscopy + PCR, the sensitivity of Paracheck™-Pf was 85.7% (95% CI, 80.8–89.8%), that of SD Bioline Ag-Pf was 85.4% (95% CI, 80.5–90.7%), and that of SD Bioline Ag-Pf/pan was 88.2% (95% CI, 83.2–92.0%). The tests performed less well in cases of low parasitaemia; however, the sensitivity was > 95% at > 500 parasites/μl. Conclusions Overall, SD Bioline malaria Ag-Pf and SD Bioline malaria Ag-Pf/pan performed slightly better than Paracheck™-Pf. Use of RDTs with reinforced microscopy practice and laboratory quality assurance should improve malaria treatment in the Central African Republic. PMID:24568311

Quality assurance in the HIV/AIDS laboratory network of China.

PubMed

Jiang, Yan; Qiu, Maofeng; Zhang, Guiyun; Xing, Wenge; Xiao, Yao; Pan, Pinliang; Yao, Jun; Ou, Chin-Yih; Su, Xueli

2010-12-01

In 2009, there were 8273 local screening laboratories, 254 confirmatory laboratories, 35 provincial confirmatory central laboratories and 1 National AIDS Reference Laboratory (NARL) in China. These laboratories were located in Center for Disease Control and Prevention (CDC) facilities, hospitals, blood donation clinics, maternal and child health (MCH) hospitals and border health quarantine health-care facilities. The NARL and provincial laboratories provide quality assurance through technical, bio-safety and managerial training; periodic proficiency testing; on-site supervisory inspections; and commercial serologic kit evaluations. From 2002 to 2009, more than 220 million HIV antibody tests were performed at screening laboratories, and all reactive and indeterminate samples were confirmed at confirmatory laboratories. The use of highly technically complex tests, including CD4 cell enumeration, viral load, dried blood spot (DBS)-based early infant diagnosis (EID), drug resistance (DR) genotyping, HIV-1 subtyping and incidence assays, have increased in recent years and their performance quality is closely monitored. China has made significant progress in establishing a well-coordinated HIV laboratory network and QA systems. However, the coverage and intensity of HIV testing and quality assurance programmes need to be strengthened so as to ensure that more infected persons are diagnosed and that they receive timely prevention and treatment services.

National Survey of Adult and Pediatric Reference Intervals in Clinical Laboratories across Canada: A Report of the CSCC Working Group on Reference Interval Harmonization.

PubMed

Adeli, Khosrow; Higgins, Victoria; Seccombe, David; Collier, Christine P; Balion, Cynthia M; Cembrowski, George; Venner, Allison A; Shaw, Julie

2017-11-01

Reference intervals are widely used decision-making tools in laboratory medicine, serving as health-associated standards to interpret laboratory test results. Numerous studies have shown wide variation in reference intervals, even between laboratories using assays from the same manufacturer. Lack of consistency in either sample measurement or reference intervals across laboratories challenges the expectation of standardized patient care regardless of testing location. Here, we present data from a national survey conducted by the Canadian Society of Clinical Chemists (CSCC) Reference Interval Harmonization (hRI) Working Group that examines variation in laboratory reference sample measurements, as well as pediatric and adult reference intervals currently used in clinical practice across Canada. Data on reference intervals currently used by 37 laboratories were collected through a national survey to examine the variation in reference intervals for seven common laboratory tests. Additionally, 40 clinical laboratories participated in a baseline assessment by measuring six analytes in a reference sample. Of the seven analytes examined, alanine aminotransferase (ALT), alkaline phosphatase (ALP), and creatinine reference intervals were most variable. As expected, reference interval variation was more substantial in the pediatric population and varied between laboratories using the same instrumentation. Reference sample results differed between laboratories, particularly for ALT and free thyroxine (FT4). Reference interval variation was greater than test result variation for the majority of analytes. It is evident that there is a critical lack of harmonization in laboratory reference intervals, particularly for the pediatric population. Furthermore, the observed variation in reference intervals across instruments cannot be explained by the bias between the results obtained on instruments by different manufacturers. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Electronic reporting of all reference laboratory results: An important step toward a truly all-encompassing, integrated health record.

PubMed

Kratz, Alexander

2016-09-01

Results from reference laboratories are often not easily available in electronic health records. This article describes a multi-pronged, long-term approach that includes bringing send-out tests in-house, upgrading the laboratory information system, interfacing more send-out tests and more reference laboratories, utilizing the "miscellaneous assay" option offered by some reference laboratories, and scanning all remaining paper reports from reference laboratories for display in the electronic health record. This allowed all laboratory results obtained in association with a patient visit, whether performed in-house or at a reference laboratory, to be available in the integrated electronic health record. This was achieved without manual data entry of reference laboratory results, thereby avoiding the risk of transcription errors. A fully integrated electronic health record that contains all laboratory results can be achieved by maximizing the number of interfaced reference laboratory assays and making all non-interfaced results available as scanned documents. © The Author(s) 2015.

International GPS Service 2001 - 2002 Technical Reports

NASA Technical Reports Server (NTRS)

Gowey, Ken (Editor); Neilan, Ruth (Editor); Moore, Angelyn (Editor)

2004-01-01

Applications of the Global Positioning System (GPS) to Earth Science are numerous. The International GPS Service (IGS), a federation of government agencies and universities, plays an increasingly critical role in support of GPS-related research and engineering activities. Contributions from the IGS Governing Board and Central Bureau, analysis and data centers, station operators, and others constitute the 2001 / 2002 Technical Reports. Hard copies of each volume can be obtained by contacting the IGS Central Bureau at the Jet Propulsion Laboratory. This report is published in black and white. To view graphs or plots that use color to represent data trends or information, please refer to the online PDF version at http://igscb.jpl.nasa.gov/overview/pubs.html.

The theory of reference values: an unfinished symphony.

PubMed

Siest, Gerard; Henny, Joseph; Gräsbeck, Ralph; Wilding, Peter; Petitclerc, Claude; Queraltó, Josep M; Hyltoft Petersen, Peter

2013-01-01

The history of the theory of reference values can be written as an unfinished symphony. The first movement, allegro con fuoco, played from 1960 to 1980: a mix of themes devoted to the study of biological variability (intra-, inter-individual, short- and long-term), preanalytical conditions, standardization of analytical methods, quality control, statistical tools for deriving reference limits, all of them complex variations developed on a central melody: the new concept of reference values that would replace the notion of normality whose definition was unclear. Additional contributions (multivariate reference values, use of reference limits from broad sets of patient data, drug interferences) conclude the movement on the variability of laboratory tests. The second movement, adagio, from 1980 to 2000, slowly develops and implements initial works. International and national recommendations were published by the IFCC-LM (International Federation of Clinical Chemistry and Laboratory Medicine) and scientific societies [French (SFBC), Spanish (SEQC), Scandinavian societies…]. Reference values are now topics of many textbooks and of several congresses, workshops, and round tables that are organized all over the world. Nowadays, reference values are part of current practice in all clinical laboratories, but not without difficulties, particularly for some laboratories to produce their own reference values and the unsuitability of the concept with respect to new technologies such as HPLC, GCMS, and PCR assays. Clinicians through consensus groups and practice guidelines have introduced their own tools, the decision limits, likelihood ratios and Reference Change Value (RCV), creating confusion among laboratorians and clinicians in substituting reference values and decision limits in laboratory reports. The rapid development of personalized medicine will eventually call for the use of individual reference values. The beginning of the second millennium is played allegro ma non-troppo from 2000 to 2012: the theory of reference values is back into fashion. The need to revise the concept is emerging. The manufacturers make a friendly pressure to facilitate the integration of Reference Intervals (RIs) in their technical documentation. Laboratorians are anxiously awaiting the solutions for what to do. The IFCC-LM creates Reference Intervals and Decision Limits Committee (C-RIDL) in 2005. Simultaneously, a joint working group IFCC-CLSI is created on the same topic. In 2008 the initial recommendations of IFCC-LM are revised and new guidelines are published by the Clinical and Laboratory Standards Institute (CLSI C28-A3). Fundamentals of the theory of reference values are not changed, but new avenues are explored: RIs transference, multicenter reference intervals, and a robust method for deriving RIs from small number of subjects. Concomitantly, other statistical methods are published such as bootstraps calculation and partitioning procedures. An alternative to recruiting healthy subjects proposes the use of biobanks conditional to the availability of controlled preanalytical conditions and of bioclinical data. The scope is also widening to include veterinary biology! During the early 2000s, several groups proposed the concept of 'Universal RIs' or 'Global RIs'. Still controversial, their applications await further investigations. The fourth movement, finale: beyond the methodological issues (statistical and analytical essentially), important questions remain unanswered. Do RIs intervene appropriately in medical decision-making? Are RIs really useful to the clinicians? Are evidence-based decision limits more appropriate? It should be appreciated that many laboratory tests represent a continuum that weakens the relevance of RIs. In addition, the boundaries between healthy and pathological states are shady areas influenced by many biological factors. In such a case the use of a single threshold is questionable. Wherever it will apply, individual reference values and reference change values have their place. A variation on an old theme! It is strange that in the period of personalized medicine (that is more stratified medicine), the concept of reference values which is based on stratification of homogeneous subgroups of healthy people could not be discussed and developed in conjunction with the stratification of sick patients. That is our message for the celebration of the 50th anniversary of Clinical Chemistry and Laboratory Medicine. Prospects are broad, enthusiasm is not lacking: much remains to be done, good luck for the new generations!

Quality-control materials in the USDA National Food and Nutrient Analysis Program (NFNAP).

PubMed

Phillips, Katherine M; Patterson, Kristine Y; Rasor, Amy S; Exler, Jacob; Haytowitz, David B; Holden, Joanne M; Pehrsson, Pamela R

2006-03-01

The US Department of Agriculture (USDA) Nutrient Data Laboratory (NDL) develops and maintains the USDA National Nutrient Databank System (NDBS). Data are released from the NDBS for scientific and public use through the USDA National Nutrient Database for Standard Reference (SR) ( http://www.ars.usda.gov/ba/bhnrc/ndl ). In 1997 the NDL initiated the National Food and Nutrient Analysis Program (NFNAP) to update and expand its food-composition data. The program included: 1) nationwide probability-based sampling of foods; 2) central processing and archiving of food samples; 3) analysis of food components at commercial, government, and university laboratories; 4) incorporation of new analytical data into the NDBS; and 5) dissemination of these data to the scientific community. A key feature and strength of the NFNAP was a rigorous quality-control program that enabled independent verification of the accuracy and precision of analytical results. Custom-made food-control composites and/or commercially available certified reference materials were sent to the laboratories, blinded, with the samples. Data for these materials were essential to ongoing monitoring of analytical work, to identify and resolve suspected analytical problems, to ensure the accuracy and precision of results for the NFNAP food samples.

North Pacific Acoustic Laboratory: Deep Water Acoustic Propagation in the Philippine Sea

DTIC Science & Technology

2010-09-30

Similar behavior had previously been observed in the central North Pacific (Gaul et al., 2007 ). The minimum noise levels presumably correspond to times...REFERENCES Gaul, R. D., D. P. Knobles, J. A. Shooter, and A. F. Wittenborn ( 2007 ), Ambient noise analysis of deep-ocean measurements in the Northeast...September 2009, Hall, J., Harrison, D. E. and Stammer , D., Eds., ESA Publication WPP-306. [in press, refereed] Farrell, W. E. and W. H. Munk (2010

[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.

[Quality assessment of microscopic examination in tuberculosis diagnostic laboratories: a preliminary study].

PubMed

Simşek, Hülya; Ceyhan, Ismail; Tarhan, Gülnur; Güner, Uğur

2010-10-01

Recently, the diagnosis of pulmonary tuberculosis (TB) has based on smear microscopy in the Direct Observed Treatment Strategy (DOTS) programme which provides the basis of treatment worldwide. Microscopic detection of AFB (Acid-Fast Bacilli) is one of the main components in the National TB Control Programmes (NTCP). Precision level in microscopy procedures and evaluations are the most important steps for accurate diagnosis of the disease and to initiate proper treatment. Therefore, the external quality assessment (EQA) is the most important implement to provide the reliability and validity of tests. In countries where NTCP are performed, this task is fulfilled by the National Reference Laboratories (NRL) according to the guidelines of the World Health Organization (WHO). For this purpose a pilot study was initiated by the central NRL of Turkey for EQA of AFB smear microscopy as part of the NTCP on January 1, 2005. A total of 5 laboratories of which 2 were district TB laboratories (A, B), 2 were tuberculosis control dispensaries (C, D), 1 was a national reference laboratory (E), participated in this study. Blind re-checking method (re-examination of randomly selected slides) was used for the evaluation, and the slides were sent to the central NRL with 3 months interval, four times a year, selected according to LQAS (Lot Quality Assurance Sampling) guides. In the re-evaluation of the slides, false positivity (FP), false negativity (FN) and quantification errors (QE) were noted. Laboratory A, sent totally 525 slides between January 1, 2005 and April 1, 2008. In the result of re-checking, 514 (97.9%) slides were found concordant, and 11 (2.1%) were discordant (10 FP, 1 FN). Laboratory B, participated in the study between October 1, 2005 and July 1, 2006 and of the 67 re-examined slides, 60 (89.5%) were concordant and 7 (10.5%) were discordant (2 FP, 0 FN, 5 QE). Laboratory C, sent 235 slides between January 1, 2005 and April 1, 2006; of them 218 (92.8%) were detected as compatible and 17 (7.2%) slides were incompatible (4 FP, 9 FN, 4 QE). Laboratory D, participated in QC for only once between January 1, 2008 and April 1, 2008; and all the 50 slides were found compatible, with no FP, FN and QE. Laboratory E, was included in the study between January 1, 2005 and January 1, 2008 and of the 696 re-checked slides, 690 (99.1%) were reported as compatible and 6 (0.9%) were incompatible (3 FN, 3 QE). Following EQA, on-site evaluation of the laboratories with major errors, was performed and necessary adjustments and training were done. In conclusion, external quality control measures for AFB microscopy is crucial and essential for the tuberculosis laboratory performances for accurate and reliable results.

Bias and precision of selected analytes reported by the National Atmospheric Deposition Program and National Trends Network, 1984

USGS Publications Warehouse

Brooks, M.H.; Schroder, L.J.; Willoughby, T.C.

1987-01-01

The U.S. Geological Survey operated a blind audit sample program during 1974 to test the effects of the sample handling and shipping procedures used by the National Atmospheric Deposition Program and National Trends Network on the quality of wet deposition data produced by the combined networks. Blind audit samples, which were dilutions of standard reference water samples, were submitted by network site operators to the central analytical laboratory disguised as actual wet deposition samples. Results from the analyses of blind audit samples were used to calculate estimates of analyte bias associated with all network wet deposition samples analyzed in 1984 and to estimate analyte precision. Concentration differences between double blind samples that were submitted to the central analytical laboratory and separate analyses of aliquots of those blind audit samples that had not undergone network sample handling and shipping were used to calculate analyte masses that apparently were added to each blind audit sample by routine network handling and shipping procedures. These calculated masses indicated statistically significant biases for magnesium, sodium , potassium, chloride, and sulfate. Median calculated masses were 41.4 micrograms (ug) for calcium, 14.9 ug for magnesium, 23.3 ug for sodium, 0.7 ug for potassium, 16.5 ug for chloride and 55.3 ug for sulfate. Analyte precision was estimated using two different sets of replicate measures performed by the central analytical laboratory. Estimated standard deviations were similar to those previously reported. (Author 's abstract)

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.

An analysis of reference laboratory (send out) testing: an 8-year experience in a large academic medical center.

PubMed

MacMillan, Donna; Lewandrowski, Elizabeth; Lewandrowski, Kent

2004-01-01

Utilization of outside reference laboratories for selected laboratory testing is common in the United States. However, relatively little data exist in the literature describing the scope and impact of these services. In this study, we reviewed use of reference laboratory testing at the Massachusetts General Hospital, a large urban academic medical center in Boston, Massachusetts. A retrospective review of hospital and laboratory administrative records over an 8-year period from fiscal years (FY) 1995-2002. Over the 8 years studied, reference laboratory expenses increased 4.2-fold and totaled 12.4% of the total laboratory budget in FY 2002. Total reference laboratory test volume increased 4-fold to 68,328 tests in FY 2002 but represented only 1.06% of the total test volume in the hospital. The menu of reference laboratory tests comprised 946 tests (65.7% of the hospital test menu) compared to 494 (34.3%) of tests performed in house. The average unit cost of reference laboratory tests was essentially unchanged but was approximately 13 times greater than the average unit cost in the hospital laboratory. Much of the growth in reference laboratory cost can be attributed to the addition of new molecular, genetic, and microbiological assays. Four of the top 10 tests with the highest total cost in 2002 were molecular diagnostic tests that were recently added to the test menu. Reference laboratory testing comprises a major component of hospital clinical laboratory services. Although send out tests represent a small percentage of the total test volume, these services account for the majority of the hospital laboratory test menu and a disproportionate percentage of laboratory costs.

[Bacterial identification methods in the microbiology laboratory].

PubMed

Bou, Germán; Fernández-Olmos, Ana; García, Celia; Sáez-Nieto, Juan Antonio; Valdezate, Sylvia

2011-10-01

In order to identify the agent responsible of the infectious process and understanding the pathogenic/pathological implications, clinical course, and to implement an effective antimicrobial therapy, a mainstay in the practice of clinical microbiology is the allocation of species to a microbial isolation. In daily routine practice microbiology laboratory phenotypic techniques are applied to achieve this goal. However, they have some limitations that are seen more clearly for some kinds of microorganism. Molecular methods can circumvent some of these limitations, although its implementation is not universal. This is due to higher costs and the level of expertise required for thei implementation, so molecular methods are often centralized in reference laboratories and centers. Recently, proteomics-based methods made an important breakthrough in the field of diagnostic microbiology and will undoubtedly have a major impact on the future organization of the microbiology services. This paper is a short review of the most noteworthy aspects of the three bacterial identification methods described above used in microbiology laboratories. Copyright © 2011 Elsevier España, S.L. All rights reserved.

Relative accuracy of the BD Logic and FreeStyle blood glucose meters.

PubMed

2007-04-01

The BD Logic((R)) (Becton, Dickinson and Co., Franklin Lakes, NJ) and FreeStyle((R)) (Abbott Diabetes Care, Alameda, CA) meters are used to transmit data directly to insulin pumps for calculation of insulin doses and to calibrate continuous glucose sensors as well as to monitor blood glucose levels. The accuracy of the two meters was evaluated in two inpatient studies conducted by the Diabetes Research in Children Network (DirecNet). In both studies, meter glucose measurements made with either venous or capillary blood were compared with reference glucose measurements made by the DirecNet Central Laboratory at the University of Minnesota using a hexokinase enzymatic method. The BD Logic tended to read lower than the laboratory reference regardless of whether venous (median difference = -9 mg/dL) or capillary blood (median difference = -7 mg/dL) was used. This resulted in lower accuracy of the BD Logic compared with the FreeStyle meter based on the median relative absolute difference (RAD) for both venous blood (median RAD, 9% vs. 5%, P < 0.001) and capillary blood (median RAD, 11% vs. 6%, P = 0.008). The greatest discrepancy in the performance of the two meters was at higher reference glucose values. Accuracy was not significantly different when the reference was < or = 70 mg/dL. The BD Logic meter is less accurate than the FreeStyle meter.

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

PubMed

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

2018-04-01

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

Impact of clinical awareness and diagnostic tests on the underdiagnosis of Clostridium difficile infection.

PubMed

Alcalá, L; Reigadas, E; Marín, M; Martín, A; Catalán, P; Bouza, E

2015-08-01

A multicenter study of Clostridium difficile infection (CDI) performed during 2008 in Spain revealed that two of every three episodes went undiagnosed or were misdiagnosed owing to nonsensitive diagnostic tests or lack of clinical suspicion and request. Since then, efforts have been made to improve the diagnostic tests used by laboratories and to increase the awareness of this disease among both clinicians and microbiologists. Our objective was to evaluate the impact of these efforts by assessing the current magnitude of underdiagnosis of CDI in Spain using two point-prevalence studies performed on one day each in January and July of 2013. A total of 111 Spanish laboratories selected all unformed stool specimens received for microbiological diagnosis on these days, and toxigenic culture was performed at a central reference laboratory. Toxigenic isolates were characterized both pheno- and genotypically. The reference laboratory detected 103 episodes of CDI in patients aged 2 years or more. Half (50.5 %) of the episodes were not diagnosed in the participating laboratories, owing to insensitive diagnostic tests (15.5 %) or the lack of clinical suspicion and request (35.0 %). The main ribotypes were 014, 078/126, 001/072, and 106. Ribotype 027 caused 2.9 % of all cases. Despite all the interventions undertaken, CDI remains a highly neglected disease because of the lack of sensitive diagnostic tests in some institutions and, especially, the absence of clinical suspicion, mainly in patients with community-associated CDI. Toxigenic C. difficile should be routinely sought in unformed stools sent for microbiological diagnosis, regardless of their origin.

A digital microfluidic system for serological immunoassays in remote settings.

PubMed

Ng, Alphonsus H C; Fobel, Ryan; Fobel, Christian; Lamanna, Julian; Rackus, Darius G; Summers, Aimee; Dixon, Christopher; Dryden, Michael D M; Lam, Charis; Ho, Man; Mufti, Nooman S; Lee, Victor; Asri, Mohd Afiq Mohd; Sykes, Edward A; Chamberlain, M Dean; Joseph, Rachael; Ope, Maurice; Scobie, Heather M; Knipes, Alaine; Rota, Paul A; Marano, Nina; Chege, Paul M; Njuguna, Mary; Nzunza, Rosemary; Kisangau, Ngina; Kiogora, John; Karuingi, Michael; Burton, John Wagacha; Borus, Peter; Lam, Eugene; Wheeler, Aaron R

2018-04-25

Serosurveys are useful for assessing population susceptibility to vaccine-preventable disease outbreaks. Although at-risk populations in remote areas could benefit from this type of information, they face several logistical barriers to implementation, such as lack of access to centralized laboratories, cold storage, and transport of samples. We describe a potential solution: a compact and portable, field-deployable, point-of-care system relying on digital microfluidics that can rapidly test a small volume of capillary blood for disease-specific antibodies. This system uses inexpensive, inkjet-printed digital microfluidic cartridges together with an integrated instrument to perform enzyme-linked immunosorbent assays (ELISAs). We performed a field validation of the system's analytical performance at Kakuma refugee camp, a remote setting in northwestern Kenya, where we tested children aged 9 to 59 months and caregivers for measles and rubella immunoglobulin G (IgG). The IgG assays were determined to have sensitivities of 86% [95% confidence interval (CI), 79 to 91% (measles)] and 81% [95% CI, 73 to 88% (rubella)] and specificities of 80% [95% CI, 49 to 94% (measles)] and 91% [95% CI, 76 to 97% (rubella)] (measles, n = 140; rubella, n = 135) compared with reference tests (measles IgG and rubella IgG ELISAs from Siemens Enzygnost) conducted in a centralized laboratory. These results demonstrate a potential role for this point-of-care system in global serological surveillance, particularly in remote areas with limited access to centralized laboratories. Copyright © 2018 The Authors, some rights reserved; exclusive licensee American Association for the Advancement of Science. No claim to original U.S. Government Works.

[The history of organization of the research laboratories based at the Department of Otorhinolaryngology of the Faculty of General Medicine].

PubMed

Lapchenko, A S; Kucherov, A G; Ivanets, I V; Aslamazova, V I; Order, R Ya; Yushkina, M A

This article was designed to describe the history of the establishment and development of the research divisions based at the Department of Otorhinolaryngology of the Faculty of General Medicine, N.I. Pirogov Russian National Research Medical University, including laser, vestibulogical, and audiological laboratories. The authors present an overview of the main research activities and achievements of the Department with special reference to the management of Meniere's disease, cochlear-vestibular disorders associated with sensorineural hearing loss, injuries to the organs of hearing, and diseases of the central nervous system. Also discussed are the peculiarities of the laser-assisted medical care and the possibilities for the application of therapeutic and surgical lasers for the purposes of the practical otorhinolaryngological work.

Estimating implementation and operational costs of an integrated tiered CD4 service including laboratory and point of care testing in a remote health district in South Africa.

PubMed

Cassim, Naseem; Coetzee, Lindi M; Schnippel, Kathryn; Glencross, Deborah K

2014-01-01

An integrated tiered service delivery model (ITSDM) has been proposed to provide 'full-coverage' of CD4 services throughout South Africa. Five tiers are described, defined by testing volumes and number of referring health-facilities. These include: (1) Tier-1/decentralized point-of-care service (POC) in a single site; Tier-2/POC-hub servicing processing < 30-40 samples from 8-10 health-clinics; Tier-3/Community laboratories servicing ∼ 50 health-clinics, processing < 150 samples/day; high-volume centralized laboratories (Tier-4 and Tier-5) processing < 300 or > 600 samples/day and serving > 100 or > 200 health-clinics, respectively. The objective of this study was to establish costs of existing and ITSDM-tiers 1, 2 and 3 in a remote, under-serviced district in South Africa. Historical health-facility workload volumes from the Pixley-ka-Seme district, and the total volumes of CD4 tests performed by the adjacent district referral CD4 laboratories, linked to locations of all referring clinics and related laboratory-to-result turn-around time (LTR-TAT) data, were extracted from the NHLS Corporate-Data-Warehouse for the period April-2012 to March-2013. Tiers were costed separately (as a cost-per-result) including equipment, staffing, reagents and test consumable costs. A one-way sensitivity analyses provided for changes in reagent price, test volumes and personnel time. The lowest cost-per-result was noted for the existing laboratory-based Tiers- 4 and 5 ($6.24 and $5.37 respectively), but with related increased LTR-TAT of > 24-48 hours. Full service coverage with TAT < 6-hours could be achieved with placement of twenty-seven Tier-1/POC or eight Tier-2/POC-hubs, at a cost-per-result of $32.32 and $15.88 respectively. A single district Tier-3 laboratory also ensured 'full service coverage' and < 24 hour LTR-TAT for the district at $7.42 per-test. Implementing a single Tier-3/community laboratory to extend and improve delivery of services in Pixley-ka-Seme, with an estimated local ∼ 12-24-hour LTR-TAT, is ∼ $2 more than existing referred services per-test, but 2-4 fold cheaper than implementing eight Tier-2/POC-hubs or providing twenty-seven Tier-1/POCT CD4 services.

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

PubMed

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

2011-07-01

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

The quality of veterinary in-clinic and reference laboratory biochemical testing.

PubMed

Rishniw, Mark; Pion, Paul D; Maher, Tammy

2012-03-01

Although evaluation of biochemical analytes in blood is common in veterinary practice, studies assessing the global quality of veterinary in-clinic and reference laboratory testing have not been reported. The aim of this study was to assess the quality of biochemical testing in veterinary laboratories using results obtained from analyses of 3 levels of assayed quality control materials over 5 days. Quality was assessed by comparison of calculated total error with quality requirements, determination of sigma metrics, use of a quality goal index to determine factors contributing to poor performance, and agreement between in-clinic and reference laboratory mean results. The suitability of in-clinic and reference laboratory instruments for statistical quality control was determined using adaptations from the computerized program, EZRules3. Reference laboratories were able to achieve desirable quality requirements more frequently than in-clinic laboratories. Across all 3 materials, > 50% of in-clinic analyzers achieved a sigma metric ≥ 6.0 for measurement of 2 analytes, whereas > 50% of reference laboratory analyzers achieved a sigma metric ≥ 6.0 for measurement of 6 analytes. Expanded uncertainty of measurement and ± total allowable error resulted in the highest mean percentages of analytes demonstrating agreement between in-clinic and reference laboratories. Owing to marked variation in bias and coefficient of variation between analyzers of the same and different types, the percentages of analytes suitable for statistical quality control varied widely. These findings reflect the current state-of-the-art with regard to in-clinic and reference laboratory analyzer performance and provide a baseline for future evaluations of the quality of veterinary laboratory testing. © 2012 American Society for Veterinary Clinical Pathology.

Determination of reference ranges for elements in human scalp hair.

PubMed

Druyan, M E; Bass, D; Puchyr, R; Urek, K; Quig, D; Harmon, E; Marquardt, W

1998-06-01

Expected values, reference ranges, or reference limits are necessary to enable clinicians to apply analytical chemical data in the delivery of health care. Determination of references ranges is not straightforward in terms of either selecting a reference population or performing statistical analysis. In light of logistical, scientific, and economic obstacles, it is understandable that clinical laboratories often combine approaches in developing health associated reference values. A laboratory may choose to: 1. Validate either reference ranges of other laboratories or published data from clinical research or both, through comparison of patients test data. 2. Base the laboratory's reference values on statistical analysis of results from specimens assayed by the clinical reference laboratory itself. 3. Adopt standards or recommendations of regulatory agencies and governmental bodies. 4. Initiate population studies to validate transferred reference ranges or to determine them anew. Effects of external contamination and anecdotal information from clinicians may be considered. The clinical utility of hair analysis is well accepted for some elements. For others, it remains in the realm of clinical investigation. This article elucidates an approach for establishment of reference ranges for elements in human scalp hair. Observed levels of analytes from hair specimens from both our laboratory's total patient population and from a physician-defined healthy American population have been evaluated. Examination of levels of elements often associated with toxicity serves to exemplify the process of determining reference ranges in hair. In addition the approach serves as a model for setting reference ranges for analytes in a variety of matrices.

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.

Public health microbiology in Germany: 20 years of national reference centers and consultant laboratories.

PubMed

Beermann, Sandra; Allerberger, Franz; Wirtz, Angela; Burger, Reinhard; Hamouda, Osamah

2015-10-01

In 1995, in agreement with the German Federal Ministry of Health, the Robert Koch Institute established a public health microbiology system consisting of national reference centers (NRCs) and consultant laboratories (CLs). The goal was to improve the efficiency of infection protection by advising the authorities on possible measures and to supplement infectious disease surveillance by monitoring selected pathogens that have high public health relevance. Currently, there are 19 NRCs and 40 CLs, each appointed for three years. In 2009, an additional system of national networks of NRCs and CLs was set up in order to enhance effectiveness and cooperation within the national reference laboratory system. The aim of these networks was to advance exchange in diagnostic methods and prevention concepts among reference laboratories and to develop geographic coverage of services. In the last two decades, the German public health laboratory reference system coped with all major infectious disease challenges. The European Union and the European Centre for Disease Prevention and Control (ECDC) are considering implementing a European public health microbiology reference laboratory system. The German reference laboratory system should be well prepared to participate actively in this upcoming endeavor. Copyright © 2015 Elsevier GmbH. All rights reserved.

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

Point-of-care device to diagnose and monitor neonatal jaundice in low-resource settings

PubMed Central

Keahey, Pelham A.; Simeral, Mathieu L.; Schroder, Kristofer J.; Bond, Meaghan M.; Mtenthaonnga, Prince J.; Miros, Robert H.; Dube, Queen

2017-01-01

Newborns are at increased risk of jaundice, a condition in which excess bilirubin accumulates in blood. Left untreated, jaundice can lead to neurological impairment and death. Jaundice resulting from unconjugated hyperbilirubinemia is easily treated with exposure to blue light, and phototherapy systems have been developed for low-resource settings; however, there are no appropriate solutions to diagnose and monitor jaundice in these settings. To address this need we present BiliSpec, a low-cost reader and disposable lateral flow card designed to measure the concentration of total bilirubin from several drops of blood at the point of care. We evaluated the performance of BiliSpec, using blood from normal volunteers spiked with varying amounts of bilirubin; results measured using BiliSpec correlated well with a reference laboratory bilirubinometer (r = 0.996). We then performed a pilot clinical study using BiliSpec to measure total bilirubin in neonates at risk for jaundice at Queen Elizabeth Central Hospital in Blantyre, Malawi. Concentrations measured using BiliSpec correlated well with those measured using a laboratory reference standard in 94 patient samples ranging from 1.1 mg/dL to 23.0 mg/dL in concentration (r = 0.973). The mean difference between bilirubin levels measured with BiliSpec and the reference standard was 0.3 mg/dL (95% CI: −1.7–2.2 mg/dL). PMID:29203650

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

Establishment of an international database for genetic variants in esophageal cancer.

PubMed

Vihinen, Mauno

2016-10-01

The establishment of a database has been suggested in order to collect, organize, and distribute genetic information about esophageal cancer. The World Organization for Specialized Studies on Diseases of the Esophagus and the Human Variome Project will be in charge of a central database of information about esophageal cancer-related variations from publications, databases, and laboratories; in addition to genetic details, clinical parameters will also be included. The aim will be to get all the central players in research, clinical, and commercial laboratories to contribute. The database will follow established recommendations and guidelines. The database will require a team of dedicated curators with different backgrounds. Numerous layers of systematics will be applied to facilitate computational analyses. The data items will be extensively integrated with other information sources. The database will be distributed as open access to ensure exchange of the data with other databases. Variations will be reported in relation to reference sequences on three levels--DNA, RNA, and protein-whenever applicable. In the first phase, the database will concentrate on genetic variations including both somatic and germline variations for susceptibility genes. Additional types of information can be integrated at a later stage. © 2016 New York Academy of Sciences.

Prospective, observational study comparing automated and visual point-of-care urinalysis in general practice

PubMed Central

van Delft, Sanne; Goedhart, Annelijn; Spigt, Mark; van Pinxteren, Bart; de Wit, Niek; Hopstaken, Rogier

2016-01-01

Objective Point-of-care testing (POCT) urinalysis might reduce errors in (subjective) reading, registration and communication of test results, and might also improve diagnostic outcome and optimise patient management. Evidence is lacking. In the present study, we have studied the analytical performance of automated urinalysis and visual urinalysis compared with a reference standard in routine general practice. Setting The study was performed in six general practitioner (GP) group practices in the Netherlands. Automated urinalysis was compared with visual urinalysis in these practices. Reference testing was performed in a primary care laboratory (Saltro, Utrecht, The Netherlands). Primary and secondary outcome measures Analytical performance of automated and visual urinalysis compared with the reference laboratory method was the primary outcome measure, analysed by calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) and Cohen's κ coefficient for agreement. Secondary outcome measure was the user-friendliness of the POCT analyser. Results Automated urinalysis by experienced and routinely trained practice assistants in general practice performs as good as visual urinalysis for nitrite, leucocytes and erythrocytes. Agreement for nitrite is high for automated and visual urinalysis. κ's are 0.824 and 0.803 (ranked as very good and good, respectively). Agreement with the central laboratory reference standard for automated and visual urinalysis for leucocytes is rather poor (0.256 for POCT and 0.197 for visual, respectively, ranked as fair and poor). κ's for erythrocytes are higher: 0.517 (automated) and 0.416 (visual), both ranked as moderate. The Urisys 1100 analyser was easy to use and considered to be not prone to flaws. Conclusions Automated urinalysis performed as good as traditional visual urinalysis on reading of nitrite, leucocytes and erythrocytes in routine general practice. Implementation of automated urinalysis in general practice is justified as automation is expected to reduce human errors in patient identification and transcribing of results. PMID:27503860

Prospective, observational study comparing automated and visual point-of-care urinalysis in general practice.

PubMed

van Delft, Sanne; Goedhart, Annelijn; Spigt, Mark; van Pinxteren, Bart; de Wit, Niek; Hopstaken, Rogier

2016-08-08

Point-of-care testing (POCT) urinalysis might reduce errors in (subjective) reading, registration and communication of test results, and might also improve diagnostic outcome and optimise patient management. Evidence is lacking. In the present study, we have studied the analytical performance of automated urinalysis and visual urinalysis compared with a reference standard in routine general practice. The study was performed in six general practitioner (GP) group practices in the Netherlands. Automated urinalysis was compared with visual urinalysis in these practices. Reference testing was performed in a primary care laboratory (Saltro, Utrecht, The Netherlands). Analytical performance of automated and visual urinalysis compared with the reference laboratory method was the primary outcome measure, analysed by calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) and Cohen's κ coefficient for agreement. Secondary outcome measure was the user-friendliness of the POCT analyser. Automated urinalysis by experienced and routinely trained practice assistants in general practice performs as good as visual urinalysis for nitrite, leucocytes and erythrocytes. Agreement for nitrite is high for automated and visual urinalysis. κ's are 0.824 and 0.803 (ranked as very good and good, respectively). Agreement with the central laboratory reference standard for automated and visual urinalysis for leucocytes is rather poor (0.256 for POCT and 0.197 for visual, respectively, ranked as fair and poor). κ's for erythrocytes are higher: 0.517 (automated) and 0.416 (visual), both ranked as moderate. The Urisys 1100 analyser was easy to use and considered to be not prone to flaws. Automated urinalysis performed as good as traditional visual urinalysis on reading of nitrite, leucocytes and erythrocytes in routine general practice. Implementation of automated urinalysis in general practice is justified as automation is expected to reduce human errors in patient identification and transcribing of results. 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/

Quantification of Cells with Specific Phenotypes I: Determination of CD4+ Cell Count Per Microliter in Reconstituted Lyophilized Human PBMC Prelabeled with Anti-CD4 FITC Antibody

PubMed Central

Stebbings, Richard; Wang, Lili; Sutherland, Janet; Kammel, Martin; Gaigalas, Adolfas K; John, Manuela; Roemer, Bodo; Kuhne, Maren; Schneider, Rudolf J; Braun, Michael; Engel, Andrea; Dikshit, Dinesh K; Abbasi, Fatima; Marti, Gerald E; Paola Sassi, Maria; Revel, Laura; Kim, Sook-Kyung; Baradez, Marc-Olivier; Lekishvili, Tamara; Marshall, Damian; Whitby, Liam; Jing, Wang; Ost, Volker; Vonsky, Maxim; Neukammer, Jörg

2015-01-01

A surface-labeled lyophilized lymphocyte (sLL) preparation has been developed using human peripheral blood mononuclear cells prelabeled with a fluorescein isothiocyanate conjugated anti-CD4 monoclonal antibody. The sLL preparation is intended to be used as a reference material for CD4+ cell counting including the development of higher order reference measurement procedures and has been evaluated in the pilot study CCQM-P102. This study was conducted across 16 laboratories from eight countries to assess the ability of participants to quantify the CD4+ cell count of this reference material and to document cross-laboratory variability plus associated measurement uncertainties. Twelve different flow cytometer platforms were evaluated using a standard protocol that included calibration beads used to obtain quantitative measurements of CD4+ T cell counts. There was good overall cross-platform and counting method agreement with a grand mean of the laboratory calculated means of (301.7 ± 4.9) μL−1 CD4+ cells. Excluding outliers, greater than 90% of participant data agreed within ±15%. A major contribution to variation of sLL CD4+ cell counts was tube to tube variation of the calibration beads, amounting to an uncertainty of 3.6%. Variation due to preparative steps equated to an uncertainty of 2.6%. There was no reduction in variability when data files were centrally reanalyzed. Remaining variation was attributed to instrument specific differences. CD4+ cell counts obtained in CCQM-P102 are in excellent agreement and show the robustness of both the measurements and the data analysis and hence the suitability of sLL as a reference material for interlaboratory comparisons and external quality assessment. © 2015 The Authors. Published by Wiley Periodicals, Inc. PMID:25655255

The Joint Committee for Traceability in Laboratory Medicine (JCTLM) - its history and operation.

PubMed

Jones, Graham R D; Jackson, Craig

2016-01-30

The Joint Committee for Traceability in Laboratory Medicine (JCTLM) was formed to bring together the sciences of metrology, laboratory medicine and laboratory quality management. The aim of this collaboration is to support worldwide comparability and equivalence of measurement results in clinical laboratories for the purpose of improving healthcare. The JCTLM has its origins in the activities of international metrology treaty organizations, professional societies and federations devoted to improving measurement quality in physical, chemical and medical sciences. The three founding organizations, the International Committee for Weights and Measures (CIPM), the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the International Laboratory Accreditation Cooperation (ILAC) are the leaders of this activity. The main service of the JCTLM is a web-based database with a list of reference materials, reference methods and reference measurement services meeting appropriate international standards. This database allows manufacturers to select references for assay traceability and provides support for suppliers of these services. As of mid 2015 the database lists 295 reference materials for 162 analytes, 170 reference measurement procedures for 79 analytes and 130 reference measurement services for 39 analytes. There remains a need for the development and implementation of metrological traceability in many areas of laboratory medicine and the JCTLM will continue to promote these activities into the future. Copyright © 2015 Elsevier B.V. All rights reserved.

The Most Proficient Enzyme as the Central Theme in an Integrated, Research-based Biochemistry Laboratory Course

ERIC Educational Resources Information Center

Smiley, Jeffrey A.

2002-01-01

The enzyme orotidine-5'-monophosphate decarboxylase is an attractive choice for the central theme of an integrated, research-based biochemistry laboratory course. A series of laboratory exercises common to most instructional laboratories, including enzyme assays, protein purification, enzymatic characterization, elementary kinetics, and…

First Nine Cases of Candida auris Infection Reported in Central America: Importance of Acurate Diagnosis and Susceptibility Testing

PubMed Central

Rodriguez, Ana Belen Arauz; Caceres, Diego H; Santiago, Erika; Armstrong, Paige; French, Amalia Rodriguez; Arosemena, Susan; Ramos, Carolina; Espinosa-Bode, Andres; Borace, Jovanna; Hayer, Lizbeth; Cedeño, Israel; Sosa, Nestor; Berkow, Elizabeth L; Lockhart, Shawn R; Jackson, Brendan R; Chiller, Tom

2017-01-01

Abstract Background Candida auris is an emerging multidrug-resistant pathogen associated with invasive infections and high mortality. This report describes the first 9 cases of C. auris in Central America in a hospital in Panama City, Panama, and highlights the challenges of accurate identification and methods for susceptibility testing. Methods Isolates initially identified at a Panama City acute care hospital during July–October 2016 as Candida haemulonii (a common misidentification for C. auris) or Candida species by Vitek® 2 automated system (bioMérieux) were further characterized by molecular methods. Antifungal susceptibility testing was performed and results were compared between standard and reference methodologies. Patient demographic, clinical, and laboratory data were collected from the medical record. Results A total of 14 isolates from 9 hospitalized patients were confirmed as C. auris. Isolates were from urine (11), blood (1), catheter tip (1) and pleural fluid (1). Results of susceptibility testing were highly discrepant between automated and reference techniques for fluconazole (92% resistant vs. 77%, respectively) and amphotericin B (100% vs. 8%). Six (67%) patients were male, and the mean age was 53 years (range 42–78). All patients were admitted to the intensive care unit and were mechanically ventilated. Seven (78%) patients died. Conclusion C. auris is present in Central America. Healthcare facilities in the region should be vigilant for this concerning pathogen, particularly given challenges in its identification and need for infection control precautions. Although automated testing overestimated amphotericin B resistance, most initial isolates were susceptible by reference testing. Disclosures All authors: No reported disclosures.

Transport equations of electrodiffusion processes in the laboratory reference frame.

PubMed

Garrido, Javier

2006-02-23

The transport equations of electrodiffusion processes use three reference frames for defining the fluxes: Fick's reference in diffusion, solvent-fixed reference in transference numbers, and laboratory fluxes in electric conductivity. The convenience of using only one reference frame is analyzed here from the point of view of the thermodynamics of irreversible processes. A relation between the fluxes of ions and solvent and the electric current density is deduced first from a mass and volume balance. This is then used to show that (i) the laboratory and Fick's diffusion coefficients are identical and (ii) the transference numbers of both the solvent and the ion in the laboratory reference frame are related. Finally, four experimental methods for the measurement of ion transference numbers are analyzed critically. New expressions for evaluating transference numbers for the moving boundary method and the chronopotentiometry technique are deduced. It is concluded that the ion transport equation in the laboratory reference frame plays a key role in the description of electrodiffusion processes.

Laser frequency stabilization and control through offset sideband locking to optical cavities.

PubMed

Thorpe, J I; Numata, K; Livas, J

2008-09-29

We describe a class of techniques whereby a laser frequency can be stabilized to a fixed optical cavity resonance with an adjustable offset, providing a wide tuning range for the central frequency. These techniques require only minor modifications to the standard Pound-Drever-Hall locking techniques and have the advantage of not altering the intrinsic stability of the frequency reference. We discuss the expected performance and limitations of these techniques and present a laboratory investigation in which both the sideband techniques and the standard, on-tunable Pound-Drever- Hall technique reached the 100Hz/square root(Hz) level.

Comparison of hematologic measurements between local and central laboratories: data from the BABY HUG trial.

PubMed

Kalpatthi, Ram; Thompson, Bruce; Lu, Ming; Wang, Winfred C; Patel, Niren; Kutlar, Abdullah; Howard, Thomas; Luchtman-Jones, Lori; Miller, Scott T

2013-02-01

To investigate the concordance of blood count indices measured locally and at a central laboratory. In a multi-center clinical trial of hydroxyurea therapy in infants with sickle cell anemia (BABY HUG), the concordance between blood count indices measured locally and at a central laboratory was investigated. Local laboratory measurements of neutrophil and monocyte counts were significantly higher (44% and 37%, respectively) compared to the central measurements (p<0.0001), and mean corpuscular volume (MCV) was higher centrally. Overnight shipping with processing delay causes spurious reductions in absolute neutrophil count (ANC) and absolute monocyte count (AMC) that may result in incorrect monitoring decisions in multicenter clinical trials. Copyright © 2012 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Estimating Implementation and Operational Costs of an Integrated Tiered CD4 Service including Laboratory and Point of Care Testing in a Remote Health District in South Africa

PubMed Central

Cassim, Naseem; Coetzee, Lindi M.; Schnippel, Kathryn; Glencross, Deborah K.

2014-01-01

Background An integrated tiered service delivery model (ITSDM) has been proposed to provide ‘full-coverage’ of CD4 services throughout South Africa. Five tiers are described, defined by testing volumes and number of referring health-facilities. These include: (1) Tier-1/decentralized point-of-care service (POC) in a single site; Tier-2/POC-hub servicing processing <30–40 samples from 8–10 health-clinics; Tier-3/Community laboratories servicing ∼50 health-clinics, processing <150 samples/day; high-volume centralized laboratories (Tier-4 and Tier-5) processing <300 or >600 samples/day and serving >100 or >200 health-clinics, respectively. The objective of this study was to establish costs of existing and ITSDM-tiers 1, 2 and 3 in a remote, under-serviced district in South Africa. Methods Historical health-facility workload volumes from the Pixley-ka-Seme district, and the total volumes of CD4 tests performed by the adjacent district referral CD4 laboratories, linked to locations of all referring clinics and related laboratory-to-result turn-around time (LTR-TAT) data, were extracted from the NHLS Corporate-Data-Warehouse for the period April-2012 to March-2013. Tiers were costed separately (as a cost-per-result) including equipment, staffing, reagents and test consumable costs. A one-way sensitivity analyses provided for changes in reagent price, test volumes and personnel time. Results The lowest cost-per-result was noted for the existing laboratory-based Tiers- 4 and 5 ($6.24 and $5.37 respectively), but with related increased LTR-TAT of >24–48 hours. Full service coverage with TAT <6-hours could be achieved with placement of twenty-seven Tier-1/POC or eight Tier-2/POC-hubs, at a cost-per-result of $32.32 and $15.88 respectively. A single district Tier-3 laboratory also ensured ‘full service coverage’ and <24 hour LTR-TAT for the district at $7.42 per-test. Conclusion Implementing a single Tier-3/community laboratory to extend and improve delivery of services in Pixley-ka-Seme, with an estimated local ∼12–24-hour LTR-TAT, is ∼$2 more than existing referred services per-test, but 2–4 fold cheaper than implementing eight Tier-2/POC-hubs or providing twenty-seven Tier-1/POCT CD4 services. PMID:25517412

Practical challenges related to point of care testing.

PubMed

Shaw, Julie L V

2016-04-01

Point of care testing (POCT) refers to laboratory testing that occurs near to the patient, often at the patient bedside. POCT can be advantageous in situations requiring rapid turnaround time of test results for clinical decision making. There are many challenges associated with POCT, mainly related to quality assurance. POCT is performed by clinical staff rather than laboratory trained individuals which can lead to errors resulting from a lack of understanding of the importance of quality control and quality assurance practices. POCT is usually more expensive than testing performed in the central laboratory and requires a significant amount of support from the laboratory to ensure the quality testing and meet accreditation requirements. Here, specific challenges related to POCT compliance with accreditation standards are discussed along with strategies that can be used to overcome these challenges. These areas include: documentation of POCT orders, charting of POCT results as well as training and certification of individuals performing POCT. Factors to consider when implementing connectivity between POCT instruments and the electronic medical record are also discussed in detail and include: uni-directional versus bidirectional communication, linking patient demographic information with POCT software, the importance of positive patient identification and considering where to chart POCT results in the electronic medical record.

Responses to a questionnaire on networking between OIE Reference Laboratories and OIE Collaborating Centres.

PubMed

Brückner, G K; Linnane, S; Diaz, F; Vallat, B

2007-01-01

Two separate questionnaires were distributed to 20 OIE Collaborating Centres and 160 OIE Reference Laboratories to assess the current status of networking and collaboration among OIE Reference Laboratories and between OIE Reference Laboratories and OIE Collaborating Centres. The questionnaire for the OIE Reference Laboratories contained 7 sections with questions on networking between laboratories, reporting of information, biosecurity quality control, and financing. Emphasis was placed in obtaining information on inter-laboratory relationships and exchange of expertise, training needs and sharing of data and information. The questionnaire for the OIE Collaborating Centres contained six sections with the emphasis on aspects related to awareness of services that can be provided, expertise that could be made available, sharing of information and the relationship with the national veterinary services of the countries concerned. The responses to the questionnaires were collated, categorised and statistically evaluated to allow for tentative inferences on the data provided. Valuable information emanated from the data identifying the current status of networking and indicating possible shortcomings that could be addressed to improve networking.

[A case of Crimean-Congo hemorrhagic fever with long incubation period in Kocaeli, Turkey].

PubMed

Meriç Koç, Meliha; Willke, Ayşe

2012-01-01

Crimean-Congo hemorrhagic fever (CCHF) is a viral hemorrhagic disease with high mortality rate. CCHF is endemic in Central Anatolia and East and Central Black Sea parts of Turkey, however sporadic cases have been detected in the other regions. The incubation period of the disease is between 1-3 days (maximum 12 days). In this report, a very rare CCHF case with a long incubation period of 30 days, was reported. A 40-year-old female patient living in a village of Kocaeli, Turkey was admitted to a health center in June 2010 with the complaints of headache, myalgia, nausea, vomiting, fatigue and fever. Since laboratory results revealed severe thrombocytopenia (18.300/mm3), the patient was referred to the university hospital in Kocaeli. It was learned from her history that she had been working in the garden and removed a tick from the skin of gluteal area a month ago without seeking any medical help. Physical examination of the patient revealed that her general condition was well, oriented and cooperative, body temperature was 36.6°C, pulse 82/minute, trombocyte count 69.400/mm3 and liver enzymes were elevated (ALT: 194 U/L, AST: 499 U/L, GGT: 384 U/L, LDH: 1290 U/L). Petecchial lesions were seen on hard palate and extremities and a hyperemic lesion was detected at the gluteal area where the tick had attached. In-house real-time polymerase chain reaction test for CCHF, performed at Refik Saydam National Public Health Agency, Virology Reference and Research Laboratory, revealed positive result. This case was presented to withdraw attention to a long incubation period CCHF and also of its epidemiological importance since it was the first case in Kocaeli province, Turkey.

Serologic screening for Trypanosoma cruzi among blood donors in central Brazil.

PubMed

de Andrade, A L; Martelli, C M; Luquetti, A O; de Oliveira, O S; Almeida e Silva, S; Zicker, F

1992-01-01

The study reported here compares results obtained by blood banks screening sera for chagasic (Trypanosoma cruzi) infection with results obtained by the Chagas' Disease Reference Laboratory of the Federal University of Goiás in Goiânia, Brazil. It also evaluates results obtained using the ELISA technique to screen the study sera. The survey used data from six of eight blood banks serving the city of Goiânia, an urban region of Central Brazil where Chagas' disease is highly endemic. The survey population consisted of 1,513 voluntary first-time blood donors whose donations occurred between October 1988 and April 1989. This group included 50% of all the first-time blood donors in that period. The six participating blood banks, which accounted for about 90% of all blood donations in Goiânia during the study period, routinely used indirect hemagglutination (IHA) and complement fixation (CF) tests to screen sera for antibodies to T. cruzi. Comparison of the results provided by the blood banks with the reference laboratory's results indicated a relative sensitivity of 77%, which ranged from 50% to 100% depending on the blood bank studied. The comparison, which found 12 false negative results, indicated that transfusions of infected blood might have occurred despite the serologic screening performed by the blood banks. Relative to the standard of positivity established for the study, the enzyme-linked immunosorbent assay (ELISA) technique was found to have a sensitivity of 96.3%. Considering as positive only those sera yielding positive IHA and indirect immunofluorescence (IIF) test results, the ELISA technique yielded 2 false negative and 41 false positive responses.(ABSTRACT TRUNCATED AT 250 WORDS)

Closely Spaced Independent Parallel Runway Simulation.

DTIC Science & Technology

1984-10-01

facility consists of the Central Computer Facility, the Controller Laboratory, and the Simulator Pilot Complex. CENTRAL COMPUTER FACILITY. The Central... Computer Facility consists of a group of mainframes, minicomputers, and associated peripherals which host the operational and data acquisition...in the Controller Laboratory and convert their verbal directives into a keyboard entry which is transmitted to the Central Computer Complex, where

Recommendation for the review of biological reference intervals in medical laboratories.

PubMed

Henny, Joseph; Vassault, Anne; Boursier, Guilaine; Vukasovic, Ines; Mesko Brguljan, Pika; Lohmander, Maria; Ghita, Irina; Andreu, Francisco A Bernabeu; Kroupis, Christos; Sprongl, Ludek; Thelen, Marc H M; Vanstapel, Florent J L A; Vodnik, Tatjana; Huisman, Willem; Vaubourdolle, Michel

2016-12-01

This document is based on the original recommendation of the Expert Panel on the Theory of Reference Values of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), updated guidelines were recently published under the auspices of the IFCC and the Clinical and Laboratory Standards Institute (CLSI). This document summarizes proposals for recommendations on: (i) The terminology, which is often confusing, noticeably concerning the terms of reference limits and decision limits. (ii) The method for the determination of reference limits according to the original procedure and the conditions, which should be used. (iii) A simple procedure allowing the medical laboratories to fulfill the requirements of the regulation and standards. The updated document proposes to verify that published reference limits are applicable to the laboratory involved. Finally, the strengths and limits of the revised recommendations (especially the selection of the reference population, the maintenance of the analytical quality, the choice of the statistical method used…) will be briefly discussed.

Make versus buy: a financial perspective.

PubMed

Kisner, Harold J

2003-01-01

Clinical laboratories are often faced with the decision to either perform a service in-house using their own assets or outsource the service to another vendor. This decision affects many aspects of the laboratory's business, from the macroeconomic perspective of outsourcing the laboratory service to a laboratory vendor, to the microeconomics of determining whether to refer a test out to their reference laboratory or perform the test in-house. The basis for decision making includes many variables, but a detailed financial analysis is usually the basis for the decision, especially when the decision only affects the laboratory and not the rest of the institution. Other factors often come into play, and depending on the magnitude, the "make versus buy" decision could be based more on strategic or political factors than economics. Even when noneconomic factors are involved, an effort usually is made to quantify those factors so that the make versus buy decision is reduced to financial terms. The previous article in this issue, "Effectively Managing Your Reference Laboratory Relationship" by Ronald L. Weiss, M.D., focused on the "buy" decision relating to managing the reference laboratory relationship. Although that article took a more clinical perspective through the eyes of the reference laboratory, this article looks at the make versus buy decision from a financial perspective through the eyes of the buying party.

Laboratory-based surveillance of Neisseria meningitidis isolates from disease cases in Latin American and Caribbean countries, SIREVA II 2006-2010.

PubMed

Ibarz-Pavón, Ana Belén; Lemos, Ana Paula; Gorla, Maria Cecilia; Regueira, Mabel; Gabastou, Jean-Marc

2012-01-01

Published data on the epidemiology of meningococcal disease in Latin America and the Caribbean region is scarce and, when available, it is often published in Spanish and/or in non-peer-reviewed journals, making it difficult for the international scientific community to have access. Laboratory data on 4,735 Neisseria meningitidis strains was collected and reported by the National Reference Laboratories in 19 Latin American countries and the Caribbean Epidemiology Centre (CAREC) between 2006 and 2010 as part of the work carried out by the SIREVA II network. Serogroup and MIC to penicillin, rifampin and chloramphenicol were determined. Isolates were mainly obtained from patients <5 years, but each year around 25% of isolates came from adult patients. Serogroup distribution was highly variable among countries. Serogroup C was the main cause of disease in Brazil; the majority of disease seen in the Southern cone was caused by serogroup B, but serogroup W135 strains have increased in recent years. In the Andean and Mexico, Central America and Caribbean regions, serogroups B and C were equally present, and serogroup Y was frequently isolated. Isolates were generally susceptible to chloramphenicol, penicillin and rifampin, but almost 60% of isolates characterized in Southern cone countries presented intermediate resistance to penicillin. Five rifampin-resistant isolates have been isolated in Uruguay and Brazil. Serogroup distribution is highly variable among countries, but some geographic structuring can be inferred from these data. Epidemiological and laboratory data are scarce among Andean and Mexico, Central America and Caribbean countries. Evaluation and implementation of corrective measures on disease surveillance and reporting systems and the implementation of molecular diagnostic techniques and molecular characterization on meningococcal isolates are advised.

Using centralized laboratory data to monitor trends in herpes simplex virus type 1 and 2 infection in British Columbia and the changing etiology of genital herpes.

PubMed

Gilbert, Mark; Li, Xuan; Petric, Martin; Krajden, Mel; Isaac-Renton, Judith L; Ogilvie, Gina; Rekart, Michael L

2011-01-01

Understanding the regional epidemiology of genital Herpes Simplex Virus (HSV) infections is important for clinical and public health practice, due to the increasing availability of type-specific serologic testing in Canada and the contribution of genital HSV-2 infection to ongoing HIV transmission. We used centralized laboratory data to describe trends in viral identifications of genital HSV in BC and assess the utility of these data for ongoing population surveillance. Records of viral identifications (1997-2005) were extracted from the Provincial Public Health Microbiology & Reference Laboratory database. Classification as genital or other site was based on documented specimen site. We conducted a descriptive analysis of trends over time, and calculated odds of HSV-1 infection among individuals with genital herpes. Of 48,183 viral identifications, 56.8% were genital, 10.0% were peri-oral and 9.1% cutaneous; site was unknown for 22.9%. Among genital identifications, HSV-1 infection was more likely in females, younger age groups, and later time periods. The proportion of genital herpes due to HSV-1 increased over time from 31.4% to 42.8% in BC. Our analysis of population-level laboratory data demonstrates that the proportion of genital herpes due to HSV-1 is increasing over time in BC, particularly among women and younger age groups; this has implications for clinical practice including the interpretation of type-specific serology. Provincial viral identification data are useful for monitoring the distribution of genital HSV-1 and HSV-2 infections over time. Improving clinical documentation of specimen site would improve the utility of these data.

Uptake of recommended common reference intervals for chemical pathology in Australia.

PubMed

Jones, Graham Rd; Koetsier, Sabrina

2017-05-01

Background Reference intervals are a vital part of reporting numerical pathology results. It is known, however, that variation in reference intervals between laboratories is common, even when analytical methods support common reference intervals. In response to this, in Australia, the Australasian Association of Clinical Biochemists together with the Royal College of Pathologists of Australasia published in 2014 a set of recommended common reference intervals for 11 common serum analytes (sodium, potassium, chloride, bicarbonate, creatinine male, creatinine female, calcium, calcium adjusted for albumin, phosphate, magnesium, lactate dehydrogenase, alkaline phosphatase and total protein). Methods Uptake of recommended common reference intervals in Australian laboratories was assessed using data from four annual cycles of the RCPAQAP reference intervals external quality assurance programme. Results Over three years, from 2013 to 2016, the use of the recommended upper and lower reference limits has increased from 40% to 83%. Nearly half of the intervals in use by enrolled laboratories in 2016 have been changed in this time period, indicating an active response to the guidelines. Conclusions These data support the activities of the Australasian Association of Clinical Biochemists and Royal College of Pathologists of Australasia in demonstrating a change in laboratory behaviour to reduce unnecessary variation in reference intervals and thus provide a consistent message to doctor and patients irrespective of the laboratory used.

Association of Reference Pricing for Diagnostic Laboratory Testing With Changes in Patient Choices, Prices, and Total Spending for Diagnostic Tests.

PubMed

Robinson, James C; Whaley, Christopher; Brown, Timothy T

2016-09-01

Prices for laboratory and other clinical services vary widely. Employers and insurers increasingly are adopting "reference pricing" policies to create incentives for patients to select lower-priced facilities. To measure the association between implementation of reference pricing and patient choice of laboratory, test prices, patient out-of-pocket spending, and insurer spending. We conducted an observational study of changes in laboratory pricing and selection by employees of a large national grocery firm (n = 30 415) before and after the firm implemented a reference pricing policy for laboratory services and compared the findings with changes over the same period for policy holders of a large national insurer that did not implement reference pricing (n = 181 831). The grocery firm established a maximum payment limit at the 60th percentile of the distribution of prices for each laboratory test in each region. Employees were provided with data on prices at all laboratories through a mobile digital platform. Patients selecting a laboratory that charged more than the payment limit were required to pay the full difference themselves. A total of 2.13 million claims were analyzed for 285 types of in vitro diagnostic tests between 2010 and 2013. Patient choice of laboratory, price paid per test, patient out-of-pocket costs, and employer spending. Compared with trends in prices paid by insurance policy holders not subject to reference pricing, and after adjusting for characteristics of tests and patients, implementation of reference pricing was associated with a 31.9% reduction (95% CI, 20.6%-41.6%) in average price paid per test by the third year of the program. In these 3 years, total spending on laboratory tests declined by $2.57 million (95% CI, $1.59-$3.35 million). Out-of-pocket costs by patients declined by $1.05 million (95% CI, $0.73-$1.37 million). Spending by the employer declined by $1.70 million (95% CI, $0.92-$2.48 million). When combined with access to price information, reference pricing was associated with patient choice of lower-cost laboratories and reductions in prices and payments by both employer and employees.

Internet-based transfer of cardiac ultrasound images

NASA Technical Reports Server (NTRS)

Firstenberg, M. S.; Greenberg, N. L.; Garcia, M. J.; Morehead, A. J.; Cardon, L. A.; Klein, A. L.; Thomas, J. D.

2000-01-01

A drawback to large-scale multicentre studies is the time required for the centralized evaluation of diagnostic images. We evaluated the feasibility of digital transfer of echocardiographic images to a central laboratory for rapid and accurate interpretation. Ten patients undergoing trans-oesophageal echocardiographic scanning at three sites had representative single images and multiframe loops stored digitally. The images were analysed in the ordinary way. All images were then transferred via the Internet to a central laboratory and reanalysed by a different observer. The file sizes were 1.5-72 MByte and the transfer rates achieved were 0.6-4.8 Mbit/min. Quantitative measurements were similar between most on-site and central laboratory measurements (all P > 0.25), although measurements differed for left atrial width and pulmonary venous systolic velocities (both P < 0.05). Digital transfer of echocardiographic images and data to a central laboratory may be useful for multicentre trials.

Impact of RNA Degradation on Viral Diagnosis: An Understated but Essential Step for the Successful Establishment of a Diagnosis Network

PubMed Central

Relova, Damarys; Acevedo, Ana M.; Coronado, Liani; Perera, Carmen L.

2018-01-01

The current global conditions, which include intensive globalization, climate changes, and viral evolution among other factors, have led to an increased emergence of viruses and new viral diseases; RNA viruses are key drivers of this evolution. Laboratory networks that are linked to central reference laboratories are required to conduct both active and passive environmental surveillance of this complicated global viral environment. These tasks require a continuous exchange of strains or field samples between different diagnostic laboratories. The shipment of these samples on dry ice represents both a biological hazard and a general health risk. Moreover, the requirement to ship on dry ice could be hampered by high costs, particularly in underdeveloped countries or regions located far from each other. To solve these issues, the shipment of RNA isolated from viral suspensions or directly from field samples could be a useful way to share viral genetic material. However, extracted RNA stored in aqueous solutions, even at −70 °C, is highly prone to degradation. The current study evaluated different RNA storage conditions for safety and feasibility for future use in molecular diagnostics. The in vitro RNA-transcripts obtained from an inactivated highly pathogenic avian influenza (HPAI) H5N1 virus was used as a model. The role of secondary structures in the protection of the RNA was also explored. Of the conditions evaluated, the dry pellet matrix was best able to protect viral RNA under extreme storage conditions. This method is safe, cost-effective and assures the integrity of RNA samples for reliable molecular diagnosis. This study aligns with the globally significant “Global One Health” paradigm, especially with respect to the diagnosis of emerging diseases that require confirmation by reference laboratories. PMID:29415432

[The laboratory of tomorrow. Particular reference to hematology].

PubMed

Cazal, P

1985-01-01

A serious prediction can only be an extrapolation of recent developments. To be exact, the development has to continue in the same direction, which is only a probability. Probable development of hematological technology: Progress in methods. Development of new labelling methods: radio-elements, antibodies. Monoclonal antibodies. Progress in equipment: Cell counters and their adaptation to routine hemograms is a certainty. From analyzers: a promise that will perhaps become reality. Coagulometers: progress still to be made. Hemagglutination detectors and their application to grouping: good achievements, but the market is too limited. Computerization and automation: What form will the computerizing take? What will the computer do? Who will the computer control? What should the automatic analyzers be? Two current levels. Relationships between the automatic analysers and the computer. rapidity, fidelity and above all, reliability. Memory: large capacity and easy access. Disadvantages: conservatism and technical dependency. How can they be avoided? Development of the environment: Laboratory input: outside supplies, electricity, reagents, consumables. Samples and their identification. Output: distribution of results and communication problems. Centralization or decentralization? What will tomorrow's laboratory be? 3 hypotheses: optimistic, pessimistic, and balanced.

Reference Ranges for Serum Uric Acid among Healthy Assamese People

PubMed Central

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

2014-01-01

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

An Integrated Tiered Service Delivery Model (ITSDM) Based on Local CD4 Testing Demands Can Improve Turn-Around Times and Save Costs whilst Ensuring Accessible and Scalable CD4 Services across a National Programme

PubMed Central

Glencross, Deborah K.; Coetzee, Lindi M.; Cassim, Naseem

2014-01-01

Background The South African National Health Laboratory Service (NHLS) responded to HIV treatment initiatives with two-tiered CD4 laboratory services in 2004. Increasing programmatic burden, as more patients access anti-retroviral therapy (ART), has demanded extending CD4 services to meet increasing clinical needs. The aim of this study was to review existing services and develop a service-model that integrated laboratory-based and point-of-care testing (POCT), to extend national coverage, improve local turn-around/(TAT) and contain programmatic costs. Methods NHLS Corporate Data Warehouse CD4 data, from 60–70 laboratories and 4756 referring health facilities was reviewed for referral laboratory workload, respective referring facility volumes and related TAT, from 2009–2012. Results An integrated tiered service delivery model (ITSDM) is proposed. Tier-1/POCT delivers CD4 testing at single health-clinics providing ART in hard-to-reach areas (<5 samples/day). Laboratory-based testing is extended with Tier-2/POC-Hubs (processing ≤30–40 CD4 samples/day), consolidating POCT across 8–10 health-clinics with other HIV-related testing and Tier-3/‘community’ laboratories, serving ≤40 health-clinics, processing ≤150 samples/day. Existing Tier-4/‘regional’ laboratories serve ≤100 facilities and process <350 samples/day; Tier-5 are high-volume ‘metro’/centralized laboratories (>350–1500 tests/day, serving ≥200 health-clinics). Tier-6 provides national support for standardisation, harmonization and quality across the organization. Conclusion The ITSDM offers improved local TAT by extending CD4 services into rural/remote areas with new Tier-3 or Tier-2/POC-Hub services installed in existing community laboratories, most with developed infrastructure. The advantage of lower laboratory CD4 costs and use of existing infrastructure enables subsidization of delivery of more expensive POC services, into hard-to-reach districts without reasonable access to a local CD4 laboratory. Full ITSDM implementation across 5 service tiers (as opposed to widespread implementation of POC testing to extend service) can facilitate sustainable ‘full service coverage’ across South Africa, and save>than R125 million in HIV/AIDS programmatic costs. ITSDM hierarchical parental-support also assures laboratory/POC management, equipment maintenance, quality control and on-going training between tiers. PMID:25490718

The Conterminous United States Mineral Appraisal Program; background information to accompany folio of geologic, geochemical, geophysical, and mineral resources maps of the Tonopah 1 by 2 degree Quadrangle, Nevada

USGS Publications Warehouse

John, David A.; Nash, J.T.; Plouff, Donald; Whitebread, D.H.

1991-01-01

The Tonopah 1 ? by 2 ? quadrangle in south-central Nevada was studied by an interdisciplinary research team to appraise its mineral resources. The appraisal is based on geological, geochemical, and geophysical field and laboratory investigations, the results of which are published as a folio of maps, figures, and tables, with accompanying discussions. This circular provides background information on the investigations and integrates the information presented in the folio. The selected bibliography lists references to the geology, geochemistry, geophysics, and mineral deposits of the Tonopah 1 ? by 2 ? quadrangle.

Fermilab computing at the Intensity Frontier

DOE PAGES

Group, Craig; Fuess, S.; Gutsche, O.; ...

2015-12-23

The Intensity Frontier refers to a diverse set of particle physics experiments using high- intensity beams. In this paper I will focus the discussion on the computing requirements and solutions of a set of neutrino and muon experiments in progress or planned to take place at the Fermi National Accelerator Laboratory located near Chicago, Illinois. In addition, the experiments face unique challenges, but also have overlapping computational needs. In principle, by exploiting the commonality and utilizing centralized computing tools and resources, requirements can be satisfied efficiently and scientists of individual experiments can focus more on the science and less onmore » the development of tools and infrastructure.« less

U.S. Geological Survey Standard Reference Sample Project: Performance Evaluation of Analytical Laboratories

USGS Publications Warehouse

Long, H. Keith; Daddow, Richard L.; Farrar, Jerry W.

1998-01-01

Since 1962, the U.S. Geological Survey (USGS) has operated the Standard Reference Sample Project to evaluate the performance of USGS, cooperator, and contractor analytical laboratories that analyze chemical constituents of environmental samples. The laboratories are evaluated by using performance evaluation samples, called Standard Reference Samples (SRSs). SRSs are submitted to laboratories semi-annually for round-robin laboratory performance comparison purposes. Currently, approximately 100 laboratories are evaluated for their analytical performance on six SRSs for inorganic and nutrient constituents. As part of the SRS Project, a surplus of homogeneous, stable SRSs is maintained for purchase by USGS offices and participating laboratories for use in continuing quality-assurance and quality-control activities. Statistical evaluation of the laboratories results provides information to compare the analytical performance of the laboratories and to determine possible analytical deficiences and problems. SRS results also provide information on the bias and variability of different analytical methods used in the SRS analyses.

[On the way to national reference system of laboratory medicine].

PubMed

Muravskaia, N P; Men'shikov, V V

2014-10-01

The application of standard samples and reference techniques of implementation of measurements is needed for a valid support of reliability of analyses applied in clinical diagnostic laboratories. They play role of landmarks under metrologic monitoring, calibration of devices and control of quality of results. The article presents analysis of shortcomings interfering with formation of national reference system in Russia harmonized with possibilities provided by international organizations. Among them are the joint Committee on metrologic monitoring in laboratory medicine under the auspices of the International Bureau of Weights and Measures, the International Federation of clinical chemistry and laboratory medicine, etc. The results of the recent development of national normative documents, standard samples and techniques assisted by the authors of article are considered. They are the first steps to organization of national reference system which would comprise all range of modern analytical technologies of laboratory medicine. The national and international measures are proposed to enhance the promptest resolving of task of organization of national reference system for laboratory medicine in the interests of increasing of effectiveness of medical care to citizen of Russia.

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.

Estrogen and progesterone receptor testing in breast carcinoma: concordance of results between local and reference laboratories in Brazil.

PubMed

Wludarski, Sheila Cristina Lordelo; Lopes, Lisandro Ferreira; Duarte, Ivison Xavier; Carvalho, Filomena Marino; Weiss, Lawrence; Bacchi, Carlos Eduardo

2011-01-01

Breast cancer accounts for approximately one quarter of all cancers in females. Estrogen and progesterone receptor testing has become an essential part of the clinical evaluation of breast carcinoma patients, and accurate results are critical in identifying patients who may benefit from hormone therapy. The present study had the aim of investigating the concordance of the results from hormone receptor tests between a reference laboratory and local (or community) laboratories in Brazil. Retrospective study at a reference pathology laboratory. The concordance in the results from hormone receptor tests between a reference laboratory and 146 local laboratories in Brazil was compared in relation to 500 invasive breast carcinoma cases, using immunohistochemistry. There was concordance in 89.4% (447/500 cases) and 85.0% (425/500 cases) of the results from estrogen (κ = 0.744, P < 0.001) and progesterone (κ = 0.688, P < 0.001) receptor tests, respectively, between local and reference laboratories. This was similar to findings in other countries. The false negative rates from estrogen and progesterone receptor tests in local laboratories were 8.7% and 14.4%, respectively. The false positive rates from estrogen and progesterone receptor tests in local laboratories were 15.5% and 16.0%, respectively. Technical and result interpretation issues may explain most of the discordances in hormone receptor testing in local laboratories. Validation of estrogen and progesterone receptor tests at local laboratories, with rigorous quality control measures, is strongly recommended in order to avoid erroneous treatment of breast cancer patients.

[Laboratory medicine in the obligatory postgraduate clinical training system--common clinical training program in the department of laboratory medicine in our prefectural medical university hospital].

PubMed

Okamoto, Yasuyuki

2003-04-01

I propose a postgraduate common clinical training program to be provided by the department of laboratory medicine in our prefectural medical university hospital. The program has three purposes: first, mastering basic laboratory tests; second, developing the skills necessary to accurately interpret laboratory data; third, learning specific techniques in the field of laboratory medicine. For the first purpose, it is important that medical trainees perform testing of their own patients at bedside or in the central clinical laboratory. When testing at the central clinical laboratory, instruction by expert laboratory technicians is helpful. The teaching doctors in the department of laboratory medicine are asked to advise the trainees on the interpretation of data. Consultation will be received via interview or e-mail. In addition, the trainees can participate in various conferences, seminars, and meetings held at the central clinical laboratory. Finally, in order to learn specific techniques in the field of laboratory medicine, several special courses lasting a few months will be prepared. I think this program should be closely linked to the training program in internal medicine.

Variable frequency microprocessor clock generator

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

Branson, C.N.

A microprocessor-based system is described comprising: a digital central microprocessor provided with a clock input and having a rate of operation determined by the frequency of a clock signal input thereto; memory means operably coupled to the central microprocessor for storing programs respectively including a plurality of instructions and addressable by the central microprocessor; peripheral device operably connected to the central microprocessor, the first peripheral device being addressable by the central microprocessor for control thereby; a system clock generator for generating a digital reference clock signal having a reference frequency rate; and frequency rate reduction circuit means connected between themore » clock generator and the clock input of the central microprocessor for selectively dividing the reference clock signal to generate a microprocessor clock signal as an input to the central microprocessor for clocking the central microprocessor.« less

National laboratory policies and plans in sub-Saharan African countries: gaps and opportunities

PubMed Central

van der Broek, Ankie; Jansen, Christel; de Bruijn, Hilde; Schultsz, Constance

2017-01-01

Background The 2008 Maputo Declaration calls for the development of dedicated national laboratory policies and strategic plans supporting the enhancement of laboratory services in response to the long-lasting relegation of medical laboratory systems in sub-Saharan Africa. Objectives This study describes the extent to which laboratories are addressed in the national health policies and plans created directly following the 2008 momentum for laboratory strengthening. Method National health policies and plans from 39 sub-Saharan African countries, valid throughout and beyond 31 December 2010 were collected in March 2012 and analysed during 2013. Results Laboratories were addressed by all countries. Human resources were the most addressed topic (38/39) and finances and budget were the least addressed (< 5/39). Countries lagging behind in national laboratory strategic planning at the end of 2013 (17/39) were more likely to be francophone countries located in West-Central Africa (13/17) and have historically low HIV prevalence. The most common gaps anticipated to compromise the implementation of the policies and plans were the disconnect between policies and plans, under-developed finance sections and monitoring and evaluating frameworks, absence of points of reference to define gaps and shortages, and inappropriate governance structure. Conclusion The availability of laboratory policy and plan implementation can be improved by strictly applying a more standardised methodology for policy development, using harmonised norms to set targets for improvement and intensifying the establishment of directorates of laboratory services directly under the authority of Ministries of Health. Horizontal programmes such as the Global Health Security Agenda could provide the necessary impulse to take the least advanced countries on board. PMID:28879152

Reference intervals and physiologic alterations in hematologic and biochemical values of free-ranging desert tortoises in the Mojave Desert

USGS Publications Warehouse

Christopher, Mary M.; Berry, Kristin H.; Wallis, I.R.; Nagy, K.A.; Henen, B.T.; Peterson, C.C.

1999-01-01

Desert tortoise (Gopherus agassizii) populations have experienced precipitous declines resulting from the cumulative impact of habitat loss, and human and disease-related mortality. Evaluation of hematologic and biochemical responses of desert tortoises to physiologic and environmental factors can facilitate the assessment of stress and disease in tortoises and contribute to management decisions and population recovery. The goal of this study was to obtain and analyze clinical laboratory data from free-ranging desert tortoises at three sites in the Mojave Desert (California, USA) between October 1990 and October 1995, to establish reference intervals, and to develop guidelines for the interpretation of laboratory data under a variety of environmental and physiologic conditions. Body weight, carapace length, and venous blood samples for a complete blood count and clinical chemistry profile were obtained from 98 clinically healthy adult desert tortoises of both sexes at the Desert Tortoise Research Natural area (western Mojave), Goffs (eastern Mojave) and Ivanpah Valley (northeastern Mojave). Samples were obtained four times per year, in winter (February/March), spring (May/June), summer (July/August), and fall (October). Years of near-, above- and below-average rainfall were represented in the 5 yr period. Minimum, maximum and median values, and central 95 percentiles were used as reference intervals and measures of central tendency for tortoises at each site and/or season. Data were analyzed using repeated measures analysis of variance for significant (P < 0.01) variation on the basis of sex, site, season, and interactions between these variables. Significant sex differences were observed for packed cell volume, hemoglobin concentration, aspartate transaminase activity, and cholesterol, triglyceride, calcium, and phosphorus concentrations. Marked seasonal variation was observed in most parameters in conjunction with reproductive cycle, hibernation, or seasonal rainfall. Year-to-year differences and long-term alterations primarily reflected winter rainfall amounts. Site differences were minimal, and largely reflected geographic differences in precipitation patterns, such that results from these studies can be applied to other tortoise populations in environments with known rainfall and forage availability patterns.

Quality Assurance of Rapid Diagnostic Tests for Malaria in Routine Patient Care in Rural Tanzania

PubMed Central

McMorrow, Meredith L.; Masanja, M. Irene; Kahigwa, Elizeus; Abdulla, Salim M. K.; Kachur, S. Patrick

2010-01-01

Histidine-rich protein II (HRP2)-based malaria rapid diagnostic tests (RDTs) have shown high sensitivity and specificity for detecting Plasmodium falciparum malaria in a variety of study settings. However, RDTs are susceptible to heat and humidity and variation in individual performance, which may affect their use in field settings. We evaluated sensitivity and specificity of RDTs during routine use for malaria case management in peripheral health facilities. From December 2007 to October 2008, HRP2-based ParaHIT-f RDTs were introduced in 12 facilities without available microscopy in Rufiji District, Tanzania. Health workers received a single day of instruction on how to perform an RDT and thick blood smear. Job aids, Integrated Management of Childhood Illness guidelines, and national malaria treatment algorithms were reviewed. For quality assurance (QA), thick blood smears for reference microscopy were collected for 2 to 3 days per week from patients receiving RDTs; microscopy was not routinely performed at the health facilities. Slides were stained and read centrally within 72 hours of collection by a reference microscopist. When RDT and blood smear results were discordant, blood smears were read by additional reference microscopists blinded to earlier results. Facilities were supervised monthly by the district laboratory supervisor or a member of the study team. Ten thousand six hundred fifty (10,650) patients were tested with RDTs, and 51.5% (5,488/10,650) had a positive test result. Blood smear results were available for 3,914 patients, of whom 40.1% (1,577/3,914) were positive for P. falciparum malaria. Overall RDT sensitivity was 90.7% (range by facility 85.7–96.5%) and specificity was 73.5% (range 50.0–84.3%). Sensitivity increased with increasing parasite density. Successful implementation of RDTs was achieved in peripheral health facilities with adequate training and supervision. Quality assurance is essential to the adequate performance of any laboratory test. Centralized staining and reading of blood smears provided useful monitoring of RDT performance. However, this level of QA may not be sustainable nationwide. PMID:20065013

Hematological reference values of healthy Malaysian population.

PubMed

Roshan, T M; Rosline, H; Ahmed, S A; Rapiaah, M; Wan Zaidah, A; Khattak, M N

2009-10-01

Health and disease can only be distinguished by accurate and reliable reference values of a particular laboratory test. It is now a proven fact that there is considerable variation in hematology reference intervals depending on the demographic and preanalytical variables. There are evidences that values provided by manufacturers do not have appropriate application for all populations. Moreover, reference ranges provided by different laboratory manuals and books also do not solve this problem. We are presenting here normal reference ranges of Malaysian population. These values were determined by using Sysmex XE-2100 and ACL 9000 hematology and coagulation analyzers. Results from this study showed that there were considerable differences in the reference values from manufacturers, western population or laboratory manuals compared with those from the local population.

[Logistics of collection and transportation of biological samples and the organization of the central laboratory in the ELSA-Brasil].

PubMed

Fedeli, Ligia G; Vidigal, Pedro G; Leite, Claudia Mendes; Castilhos, Cristina D; Pimentel, Robércia Anjos; Maniero, Viviane C; Mill, Jose Geraldo; Lotufo, Paulo A; Pereira, Alexandre C; Bensenor, Isabela M

2013-06-01

The ELSA (Estudo Longitudinal de Saúde do Adulto - Brazilian Longitudinal Study for Adult Health) is a multicenter cohort study which aims at the identification of risk factors associated with type 2 diabetes and cardiovascular diseases in the Brazilian population. The paper describes the strategies for the collection, processing, transportation, and quality control of blood and urine tests in the ELSA. The study decided to centralize the tests at one single laboratory. The processing of the samples was performed at the local laboratories, reducing the weight of the material to be transported, and diminishing the costs of transportation to the central laboratory at the Universidade de São Paulo Hospital. The study included tests for the evaluation of diabetes, insulin resistance, dyslipidemia, electrolyte abnormalities, thyroid hormones, uric acid, hepatic enzyme abnormalities, inflammation, and total blood cell count. In addition, leukocyte DNA, urine, plasma and serum samples were stored. The central laboratory performed approximately 375,000 tests.

A UK NEQAS ICC and ISH multicentre study using the Kreatech Poseidon HER2 FISH probe: intersite variation can be rigorously controlled using FISH.

PubMed

Bartlett, John M S; Campbell, Fiona M; Ibrahim, Merdol; Thomas, Jeremy; Wencyk, Pete; Ellis, Ian; Kay, Elaine; Connolly, Yvonne; O'Grady, Anthony; Barnett, Sarah; Starczynski, Jane; Cunningham, Paul; Miller, Keith

2010-02-01

To assess a new HER2 fluorescence in situ hybridization (FISH) test and report on multicentre intrasite and intersite variation. HER2 results were scored from 45 breast cancers in eight laboratories using the Kreatech Poseidon HER2 FISH probe (Kreatech Diagnostics, Amsterdam, the Netherlands). Overall, 80.9% of cores were successfully analysed. Mean intrasite variation for HER2 ratio assessment was low (4.74%). Intersite variation in ratio was in line with previous reports (11.9+/-0.8%) for both reference and non-reference laboratories; only one laboratory displayed significantly higher intersite variation (P=0.009) than the remaining seven laboratories. The overall incidence of misclassification of cores was <1.3%, demonstrating an excellent level of concordance (>98.7%) across all eight laboratories, irrespective of whether they were 'reference' or 'routine diagnostic' laboratories. The Kreatech Poseidon HER2 FISH test is robust and reproducible. Highly quantitatively reproducible FISH results were obtained from eight 'diagnostic' and 'reference' laboratories; however, continued quality assessments are essential to good performance.

Enhancing Chemical Inventory Management in Laboratory through a Mobile-Based QR Code Tag

NASA Astrophysics Data System (ADS)

Shukran, M. A. M.; Ishak, M. S.; Abdullah, M. N.

2017-08-01

The demand for a greater inventory management system which can provide a lot of useful information from a single scan has made laboratory inventory management using barcode technology more difficult. Since the barcode technology lacks the ability to overcome the problem and is not capable of providing information needed to manage the chemicals in the laboratory, thus employing a QR code technology is the best solution. In this research, the main idea is to develop a standalone application running with its own database that is periodically synchronized with the inventory software hosted by the computer and connected to a specialized network as well. The first process required to establish this centralized system is to determine all inventory available in the chemical laboratory by referring to the documented data in order to develop the database. Several customization and enhancement were made to the open source QR code technology to ensure the developed application is dedicated for its main purposes. As the end of the research, it was proven that the system is able to track the position of all inventory and showing real time information about the scanned chemical labels. This paper intends to give an overview about the QR tag inventory system that was developed and its implementation at the National Defence University of Malaysia’s (NDUM) chemical laboratory.

Reference values of thirty-one frequently used laboratory markers for 75-year-old males and females

PubMed Central

Ryden, Ingvar; Lind, Lars

2012-01-01

Background We have previously reported reference values for common clinical chemistry tests in healthy 70-year-old males and females. We have now repeated this study 5 years later to establish reference values also at the age of 75. It is important to have adequate reference values for elderly patients as biological markers may change over time, and adequate reference values are essential for correct clinical decisions. Methods We have investigated 31 frequently used laboratory markers in 75-year-old males (n = 354) and females (n = 373) without diabetes. The 2.5 and 97.5 percentiles for these markers were calculated according to the recommendations of the International Federation of Clinical Chemistry. Results Reference values are reported for 75-year-old males and females for 31 frequently used laboratory markers. Conclusion There were minor differences between reference intervals calculated with and without individuals with cardiovascular diseases. Several of the reference intervals differed from Scandinavian reference intervals based on younger individuals (Nordic Reference Interval Project). PMID:22300333

33 Shafts Category of Transuranic Waste Stored Below Ground within Area G

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

Hargis, Kenneth Marshall; Monk, Thomas H

This report compiles information to support the evaluation of alternatives and analysis of regulatory paths forward for the 33 shafts. The historical information includes a form completed by waste generators for each waste package (Reference 6) that included a waste description, estimates of Pu-239 and uranium-235 (U-235) based on an accounting technique, and calculations of mixed fission products (MFP) based on radiation measurements. A 1979 letter and questionnaire (Reference 7) provides information on waste packaging of hot cell waste and the configuration of disposal shafts as storage in the 33 Shafts was initiated. Tables of data by waste package weremore » developed during a review of historical documents that was performed in 2005 (Reference 8). Radiological data was coupled with material-type data to estimate the initial isotopic content of each waste package and an Oak Ridge National Laboratory computer code was used to calculate 2009 decay levels. Other sources of information include a waste disposal logbook for the 33 shafts (Reference 9), reports that summarize remote-handled waste generated at the CMR facility (Reference 10) and placement of waste in the 33 shafts (Reference 11), a report on decommissioning of the LAMPRE reactor (Reference 12), interviews with an employee and manager involved in placing waste in the 33 shafts (References 13 and 14), an interview with a long-time LANL employee involved in waste operations (Reference 15), a 2002 plan for disposition of remote-handled TRU waste (Reference 16), and photographs obtained during field surveys of several shafts in 2007. The WIPP Central Characterization Project (CCP) completed an Acceptable Knowledge (AK) summary report for 16 canisters of remote-handled waste from the CMR Facility that contains information relevant to the 33 Shafts on hot-cell operations and timeline (Reference 17).« less

Comparison of estrogen receptor results from pathology reports with results from central laboratory testing.

PubMed

Collins, Laura C; Marotti, Jonathan D; Baer, Heather J; Tamimi, Rulla M

2008-02-06

We compared estrogen receptor (ER) assay results abstracted from pathology reports with ER results determined on the same specimens by a central laboratory with an immunohistochemical assay. Paraffin sections were cut from tissue microarrays containing 3093 breast cancer specimens from women enrolled in the Nurses' Health Study, 1851 of which had both pathology reports and tissue available for central laboratory testing. All sections were immunostained for ER at the same time. The original assays were biochemical for 1512 (81.7%) of the 1851 specimens, immunohistochemical for 336 (18.2%), and immunofluorescent for three (0.2%). ER results from pathology reports and repeat central laboratory testing were in agreement for 87.3% of specimens (1615 of the 1851 specimens; kappa statistic = 0.64, P < .001). When the comparison was restricted to the specimens for which the ER assays were originally performed by immunohistochemistry, the agreement rate increased to 92.3% of specimens (310 of the 336 specimens; kappa statistic = 0.78, P < .001). Thus, ER assay results from pathology reports appear to be a reasonable alternative to central laboratory ER testing for large, population-based studies of patients with breast cancer.

Results of the U. S. Geological Survey's analytical evaluation program for standard reference samples distributed in April 2001

USGS Publications Warehouse

Woodworth, M.T.; Connor, B.F.

2001-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for six standard reference samples -- T-165 (trace constituents), M-158 (major constituents), N-69 (nutrient constituents), N-70 (nutrient constituents), P-36 (low ionic-strength constituents), and Hg-32 (mercury) -- that were distributed in April 2001 to laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data received from 73 laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Results of the U. S. Geological Survey's Analytical Evaluation Program for Standard Reference Samples Distributed in March 2002

USGS Publications Warehouse

Woodworth, M.T.; Conner, B.F.

2002-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for six standard reference samples -- T- 169 (trace constituents), M- 162 (major constituents), N-73 (nutrient constituents), N-74 (nutrient constituents), P-38 (low ionic-strength constituents), and Hg-34 (mercury) -- that were distributed in March 2002 to laboratories enrolled in the U.S. Geological Survey sponsored intedaboratory testing program. Analytical data received from 93 laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Results of the U.S. Geological Survey's analytical evaluation program for standard reference samples distributed in September 2002

USGS Publications Warehouse

Woodworth, Mark T.; Connor, Brooke F.

2003-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for six standard reference samples -- T-171 (trace constituents), M-164 (major constituents), N-75 (nutrient constituents), N-76 (nutrient constituents), P-39 (low ionic-strength constituents), and Hg-35 (mercury) -- that were distributed in September 2002 to laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data received from 102 laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Results of the U.S. Geological Survey's analytical evaluation program for standard reference samples distributed in September 2001

USGS Publications Warehouse

Woodworth, Mark T.; Connor, Brooke F.

2002-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for six standard reference samples -- T-167 (trace constituents), M-160 (major constituents), N-71 (nutrient constituents), N-72 (nutrient constituents), P-37 (low ionic-strength constituents), and Hg-33 (mercury) -- that were distributed in September 2001 to laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data received from 98 laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Results of the U.S. Geological Survey's Analytical Evaluation Program for Standard Reference Samples Distributed in March 2000

USGS Publications Warehouse

Farrar, Jerry W.; Copen, Ashley M.

2000-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for six standard reference samples -- T-161 (trace constituents), M-154 (major constituents), N-65 (nutrient constituents), N-66 nutrient constituents), P-34 (low ionic strength constituents), and Hg-30 (mercury) -- that were distributed in March 2000 to 144 laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 132 of the laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Results of the U.S. Geological Survey's analytical evaluation program for standard reference samples distributed in October 1999

USGS Publications Warehouse

Farrar, T.W.

2000-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for six standard reference samples -- T-159 (trace constituents), M-152 (major constituents), N-63 (nutrient constituents), N-64 (nutrient constituents), P-33 (low ionic strength constituents), and Hg-29 (mercury) -- that were distributed in October 1999 to 149 laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 131 of the laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Results of the U.S. Geological Survey's analytical evaluation program for standard reference samples distributed in March 2003

USGS Publications Warehouse

Woodworth, Mark T.; Connor, Brooke F.

2003-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for six standard reference samples -- T-173 (trace constituents), M-166 (major constituents), N-77 (nutrient constituents), N-78 (nutrient constituents), P-40 (low ionic-strength constituents), and Hg-36 (mercury) -- that were distributed in March 2003 to laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data received from 110 laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Results of the U. S. Geological Survey's analytical evaluation program for standard reference samples distributed in October 2000

USGS Publications Warehouse

Connor, B.F.; Currier, J.P.; Woodworth, M.T.

2001-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for six standard reference samples -- T-163 (trace constituents), M-156 (major constituents), N-67 (nutrient constituents), N-68 (nutrient constituents), P-35 (low ionic strength constituents), and Hg-31 (mercury) -- that were distributed in October 2000 to 126 laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 122 of the laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

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

PubMed

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

2010-08-01

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

Microscopic diagnosis of sodium acetate-acetic acid-formalin-fixed stool samples for helminths and intestinal protozoa: a comparison among European reference laboratories.

PubMed

Utzinger, J; Botero-Kleiven, S; Castelli, F; Chiodini, P L; Edwards, H; Köhler, N; Gulletta, M; Lebbad, M; Manser, M; Matthys, B; N'Goran, E K; Tannich, E; Vounatsou, P; Marti, H

2010-03-01

The present study aimed to compare the diagnostic performance of different European reference laboratories in diagnosing helminths and intestinal protozoa, using an ether-concentration method applied to sodium acetate-acetic acid-formalin (SAF)-preserved faecal samples. In total, 102 stool specimens were analysed during a cross-sectional parasitological survey in urban farming communities in Côte d'Ivoire. Five SAF-preserved faecal samples were prepared from each specimen and forwarded to the participating reference laboratories, processed and examined under a microscope adhering to a standard operating procedure (SOP). Schistosoma mansoni (cumulative prevalence: 51.0%) and hookworm (cumulative prevalence: 39.2%) were the predominant helminths. There was excellent agreement (kappa > 0.8; p < 0.001) among the reference laboratories for the diagnosis of S. mansoni, hookworm, Trichuris trichiura and Ascaris lumbricoides. Moderate agreement (kappa = 0.54) was found for Hymenolepis nana, and lesser agreement was observed for other, less prevalent helminths. The predominant intestinal protozoa were Entamoeba coli (median prevalence: 67.6%), Blastocystis hominis (median prevalence: 55.9%) and Entamoeba histolytica/Entamoeba dispar (median prevalence: 47.1%). Substantial agreement among reference laboratories was found for E. coli (kappa = 0.69), but only fair or moderate agreement was found for other Entamoeba species, Giardia intestinalis and Chilomastix mesnili. There was only poor agreement for B. hominis, Isospora belli and Trichomonas intestinalis. In conclusion, although common helminths were reliably diagnosed by European reference laboratories, there was only moderate agreement between centres for pathogenic intestinal protozoa. Continued external quality assessment and the establishment of a formal network of reference laboratories is necessary to further enhance both accuracy and uniformity in parasite diagnosis.

Measurement of gauge blocks by interferometry

NASA Astrophysics Data System (ADS)

Matus, M.; Haas, S.; Piree, H.; Gavalyugov, V.; Tamakyarska, D.; Thalmann, R.; Balling, P.; Garnaes, J.; Hald, J.; Farid, N.; Prieto, E.; Lassila, A.; Salgado, J. A.; Lewis, A.; Bandis, C.; Mudronja, V.; Banreti, E.; Balsamo, A.; Pedone, P.; Bergmans, R. H.; Karlsson, H.; Ramotowski, Z.; Eusebio, L.; Saraiva, F.; Duta, A.; Zelenika, S.; Bergstrand, S.; Fira, R.; Yandayan, T.; Sendogdu, D.; Ganioglu, O.; Asli Akgoz, S.; Franke, P.

2016-01-01

The key comparison EURAMET.L-K1.2011 on gauge blocks was carried out in the framework of a EURAMET project starting in 2012 and ending in 2015. It involved the participation of 24 National Metrology Institutes from Europe and Egypt, respectively. 38 gauge blocks of steel and ceramic with nominal central lengths between 0.5 mm and 500 mm were circulated. The comparison was conducted in two loops with two sets of artifacts. A statistical technique for linking the reference values was applied. As a consequence the reference value of one loop is influenced by the measurements of the other loop although they did not even see the artifacts of the others. This influence comes solely from three "linking laboratories" which measure both sets of artifacts. In total there were 44 results were not fully consistent with the reference values. This represents 10% of the full set of 420 results which is a considerable high number. At least 12 of them are clearly outliers where the participants have been informed by the pilot as soon as possible. The comparison results help to support the calibration and measurement capabilities (CMCs) of the laboratories involved in the CIPM MRA. Main text To reach the main text of this paper, click on Final Report. Note that this text is that which appears in Appendix B of the BIPM key comparison database kcdb.bipm.org/. The final report has been peer-reviewed and approved for publication by the CCL, according to the provisions of the CIPM Mutual Recognition Arrangement (CIPM MRA).

SENIORLAB: a prospective observational study investigating laboratory parameters and their reference intervals in the elderly.

PubMed

Risch, Martin; Nydegger, Urs; Risch, Lorenz

2017-01-01

In clinical practice, laboratory results are often important for making diagnostic, therapeutic, and prognostic decisions. Interpreting individual results relies on accurate reference intervals and decision limits. Despite the considerable amount of resources in clinical medicine spent on elderly patients, accurate reference intervals for the elderly are rarely available. The SENIORLAB study set out to determine reference intervals in the elderly by investigating a large variety of laboratory parameters in clinical chemistry, hematology, and immunology. The SENIORLAB study is an observational, prospective cohort study. Subjectively healthy residents of Switzerland aged 60 years and older were included for baseline examination (n = 1467), where anthropometric measurements were taken, medical history was reviewed, and a fasting blood sample was drawn under optimal preanalytical conditions. More than 110 laboratory parameters were measured, and a biobank was set up. The study participants are followed up every 3 to 5 years for quality of life, morbidity, and mortality. The primary aim is to evaluate different laboratory parameters at age-related reference intervals. The secondary aims of this study include the following: identify associations between different parameters, identify diagnostic characteristics to diagnose different circumstances, identify the prevalence of occult disease in subjectively healthy individuals, and identify the prognostic factors for the investigated outcomes, including mortality. To obtain better grounds to justify clinical decisions, specific reference intervals for laboratory parameters of the elderly are needed. Reference intervals are obtained from healthy individuals. A major obstacle when obtaining reference intervals in the elderly is the definition of health in seniors because individuals without any medical condition and any medication are rare in older adulthood. Reference intervals obtained from such individuals cannot be considered representative for seniors in a status of age-specific normal health. In addition to the established methods for determining reference intervals, this longitudinal study utilizes a unique approach, in that survival and long-term well-being are taken as indicators of health in seniors. This approach is expected to provide robust and representative reference intervals that are obtained from an adequate reference population and not a collective of highly selected individuals. The present study was registered under International Standard Randomized Controlled Trial Number registry: ISRCTN53778569.

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.

Assessment of a Technique for Estimating Total Column Water Vapor Using Measurements of the Infrared Sky Temperature

NASA Technical Reports Server (NTRS)

Merceret, Francis J.; Huddleston, Lisa L.

2014-01-01

A method for estimating the integrated precipitable water (IPW) content of the atmosphere using measurements of indicated infrared zenith sky temperature was validated over east-central Florida. The method uses inexpensive, commercial off the shelf, hand-held infrared thermometers (IRT). Two such IRTs were obtained from a commercial vendor, calibrated against several laboratory reference sources at KSC, and used to make IR zenith sky temperature measurements in the vicinity of KSC and Cape Canaveral Air Force Station (CCAFS). The calibration and comparison data showed that these inexpensive IRTs provided reliable, stable IR temperature measurements that were well correlated with the NOAA IPW observations.

External Quality Assessment Scheme for reference laboratories - review of 8 years' experience.

PubMed

Kessler, Anja; Siekmann, Lothar; Weykamp, Cas; Geilenkeuser, Wolf Jochen; Dreazen, Orna; Middle, Jonathan; Schumann, Gerhard

2013-05-01

We describe an External Quality Assessment Scheme (EQAS) intended for reference (calibration) laboratories in laboratory medicine and supervised by the Scientific Division of the International Federation of Clinical Chemistry and Laboratory Medicine and the responsible Committee on Traceability in Laboratory Medicine. The official EQAS website, RELA (www.dgkl-rfb.de:81), is open to interested parties. Information on all requirements for participation and results of surveys are published annually. As an additional feature, the identity of every participant in relation to the respective results is disclosed. The results of various groups of measurands (metabolites and substrates, enzymes, electrolytes, glycated hemoglobins, proteins, hormones, thyroid hormones, therapeutic drugs) are discussed in detail. The RELA system supports reference measurement laboratories preparing for accreditation according to ISO 17025 and ISO 15195. Participation in a scheme such as RELA is one of the requirements for listing of the services of a calibration laboratory by the Joint Committee on Traceability in Laboratory Medicine.

An automated and objective method for age partitioning of reference intervals based on continuous centile curves.

PubMed

Yang, Qian; Lew, Hwee Yeong; Peh, Raymond Hock Huat; Metz, Michael Patrick; Loh, Tze Ping

2016-10-01

Reference intervals are the most commonly used decision support tool when interpreting quantitative laboratory results. They may require partitioning to better describe subpopulations that display significantly different reference values. Partitioning by age is particularly important for the paediatric population since there are marked physiological changes associated with growth and maturation. However, most partitioning methods are either technically complex or require prior knowledge of the underlying physiology/biological variation of the population. There is growing interest in the use of continuous centile curves, which provides seamless laboratory reference values as a child grows, as an alternative to rigidly described fixed reference intervals. However, the mathematical functions that describe these curves can be complex and may not be easily implemented in laboratory information systems. Hence, the use of fixed reference intervals is expected to continue for a foreseeable time. We developed a method that objectively proposes optimised age partitions and reference intervals for quantitative laboratory data (http://research.sph.nus.edu.sg/pp/ppResult.aspx), based on the sum of gradient that best describes the underlying distribution of the continuous centile curves. It is hoped that this method may improve the selection of age intervals for partitioning, which is receiving increasing attention in paediatric laboratory medicine. Copyright © 2016 Royal College of Pathologists of Australasia. Published by Elsevier B.V. All rights reserved.

Activities of the Korean Institute of Tuberculosis

PubMed Central

Ryoo, Sungweon; Kim, Hee Jin

2014-01-01

The Korean National Tuberculosis Association (KNTA) set up the Korean Institute of Tuberculosis (KIT) in 1970 to foster research and technical activities pertaining to tuberculosis (TB). The KNTA/KIT had successfully conducted a countrywide TB prevalence survey from 1965 to 1995 at 5-year intervals. The survey results (decline in TB rates) established Korea as a country that had successfully implemented national control programs for TB. The KIT developed the Korea Tuberculosis Surveillance System and the Laboratory Management Information System, both of which were transferred to the Korea Centers for Disease Control and Prevention after its establishment. The KIT functions as a central and supranational reference TB laboratory for microbiological and epidemiological research and provides training and education for health-care workers and medical practitioners. Recently, the KIT has expanded its activities to countries such as Ethiopia, Laos, and Timor-Leste to support TB control and prevention. The KIT will continue to support research activities and provide technical assistance in diagnosing the infection until it is completely eliminated in Korea. PMID:25861580

Data on nearshore wave process and surficial beach deposits, central Tamil Nadu coast, India.

PubMed

Joevivek, V; Chandrasekar, N

2017-08-01

The chronicles of nearshore morphology and surficial beach deposits provide valuable information about the nature of the beach condition and the depositional environment. It imparts an understanding about the spatial and temporal relationship of nearshore waves and its influence over the distribution of beach sediments. This article contains data about wave and sediment dynamics of the ten sandy beaches along the central Tamil Nadu coast, India. This present dataset comprises nearshore wave parameters, breaker wave type, beach morphodynamic state, grain size distribution and weight percentage of heavy and light mineral distribution. The dataset will figure out the beach morphology and hydrodynamic condition with respect to the different monsoonal season. This will act as a field reference to realize the coastal dynamics in an open sea condition. The nearshore entities were obtained from the intensive field survey between January 2011 and December 2011, while characteristics of beach sediments are examined by the chemical process in the laboratory environment.

Genetic diversity of Mycobacterium tuberculosis strains isolated in Algeria: Results of spoligotyping.

PubMed

Ifticene, Malika; Kaïdi, Saïd; Khechiba, Mesbah-Mounir; Yala, Djamel; Boulahbal, Fadila

2015-12-01

Molecular typing tools, including spoligotyping, are currently widely used in the monitoring and study of the dynamics of tuberculosis epidemics. A study of the molecular profile of a sample of 129 Myobacterium tuberculosis strains isolated during 2011 was carried out in the National Reference Laboratory for Tuberculosis and Mycobacteria at the Pasteur Institute of Algeria. This sample was selected at random from a set of 350 strains isolated from tuberculosis patients from central and eastern areas of the country. Genotypic analysis helped to clarify the frequencies of the different genotypes in the current study population: H family, 29%; LAM family, 26%; T family, 25%; S family, 5%, and other genomic families, including orphan strains, 15%. The study of strains isolated between January and December 2011 has allowed insight into the frequency of different genomic families and the importance of existing clusters in the population of central and eastern Algeria. Copyright © 2015 Asian African Society for Mycobacteriology. Published by Elsevier Ltd. All rights reserved.

Quality assurance and quality control in light stable isotope laboratories: A case study of Rio Grande, Texas, water samples

USGS Publications Warehouse

Coplen, T.B.; Qi, H.

2009-01-01

New isotope laboratories can achieve the goal of reporting the same isotopic composition within analytical uncertainty for the same material analysed decades apart by (1) writing their own acceptance testing procedures and putting them into their mass spectrometric or laser-based isotope-ratio equipment procurement contract, (2) requiring a manufacturer to demonstrate acceptable performance using all sample ports provided with the instrumentation, (3) for each medium to be analysed, prepare two local reference materials substantially different in isotopic composition to encompass the range in isotopic composition expected in the laboratory and calibrated them with isotopic reference materials available from the International Atomic Energy Agency (IAEA) or the US National Institute of Standards and Technology (NIST), (4) using the optimum storage containers (for water samples, sealing in glass ampoules that are sterilised after sealing is satisfactory), (5) interspersing among sample unknowns local laboratory isotopic reference materials daily (internationally distributed isotopic reference materials can be ordered at three-year intervals, and can be used for elemental analyser analyses and other analyses that consume less than 1 mg of material) - this process applies to H, C, N, O, and S isotope ratios, (6) calculating isotopic compositions of unknowns by normalising isotopic data to that of local reference materials, which have been calibrated to internationally distributed isotopic reference materials, (7) reporting results on scales normalised to internationally distributed isotopic reference materials (where they are available) and providing to sample submitters the isotopic compositions of internationally distributed isotopic reference materials of the same substance had they been analysed with unknowns, (8) providing an audit trail in the laboratory for analytical results - this trail commonly will be in electronic format and might include a laboratory information management system, (9) making at regular intervals a complete backup of laboratory analytical data (both of samples logged into the laboratory and of mass spectrometric analyses), being sure to store one copy of this backup offsite, and (10) participating in interlaboratory comparison exercises sponsored by the IAEA and other agencies at regular intervals. ?? Taylor & Francis.

[Establishing biological reference intervals of alanine transaminase for clinical laboratory stored database].

PubMed

Guo, Wei; Song, Binbin; Shen, Junfei; Wu, Jiong; Zhang, Chunyan; Wang, Beili; Pan, Baishen

2015-08-25

To establish an indirect reference interval based on the test results of alanine aminotransferase stored in a laboratory information system. All alanine aminotransferase results were included for outpatients and physical examinations that were stored in the laboratory information system of Zhongshan Hospital during 2014. The original data were transformed using a Box-Cox transformation to obtain an approximate normal distribution. Outliers were identified and omitted using the Chauvenet and Tukey methods. The indirect reference intervals were obtained by simultaneously applying nonparametric and Hoffmann methods. The reference change value was selected to determine the statistical significance of the observed differences between the calculated and published reference intervals. The indirect reference intervals for alanine aminotransferase of all groups were 12 to 41 U/L (male, outpatient), 12 to 48 U/L (male, physical examination), 9 to 32 U/L (female, outpatient), and 8 to 35 U/L (female, physical examination), respectively. The absolute differences when compared with the direct results were all smaller than the reference change value of alanine aminotransferase. The Box-Cox transformation combined with the Hoffmann and Tukey methods is a simple and reliable technique that should be promoted and used by clinical laboratories.

Establishment of Traceability of Reference Grade Hydrometers at National Physical Laboratory, India (npli)

NASA Astrophysics Data System (ADS)

Kumar, Anil; Kumar, Harish; Mandal, Goutam; Das, M. B.; Sharma, D. C.

The present paper discusses the establishment of traceability of reference grade hydrometers at National Physical Laboratory, India (NPLI). The reference grade hydrometers are calibrated and traceable to the primary solid density standard. The calibration has been done according to standard procedure based on Cuckow's Method and the reference grade hydrometers calibrated covers a wide range. The uncertainty of the reference grade hydrometers has been computed and corrections are also calculated for the scale readings, at which observations are taken.

Report on the U.S. Geological Survey's Evaluation Program Standard Reference Samples Distributed in October 1995: T-137 (Trace Constituents), M-136 (Major Constituents), N-47 (Nutrient Constituents), N-48 (Nutrient Constituents), P-25 (Low Ionic Strength Constituents), and Hg-21 (Mercury)

USGS Publications Warehouse

Farrar, Jerry W.; Long, H. Keith

1996-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for 6 standard reference samples--T-137 (trace constituents), M-136 (major constituents), N-47 (nutrient constituents), N-48 (nutrient constituents), P-25 (low ionic strength constituents), and Hg-21 (mercury)--that were distributed in October 1995 to 149 laboratories registered in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 136 of the laboratories were evaluated with respect to: overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Report on the U.S. Geological Survey's evaluation program for standard reference samples distributed in April 1994; T-129 (trace constituents), M-130 (major constituents), N-42 (nutrients), P-22 (low ionic strength), and Hg-18 (mercury)

USGS Publications Warehouse

Long, H. Keith; Farrar, Jerry W.

1994-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for five standard reference samples--T-129 (trace constituents), M-130 (major constituents), N-42 (nutrients), P-22 (low ionic strength), Hg-18(mercury),--that were distributed in April 1994 to 157 laboratories registered in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 133 of the laboratories were evaluated with respect to: overall laboratory performance and relative laboratory performance for each analyte in the five reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the five standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Report of the U.S. Geological Survey's evaluation program for standard reference samples distributed in April 1993; T-123 (trace constituents), T-125 (trace constituents), M-126 (major constituents, N-38 (nutrients), N-39 (nutrients), P-20 (low ionic strength, and Hg-16 (mercury)

USGS Publications Warehouse

Long, H.K.; Farrar, J.W.

1993-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for seven standard reference samples--T-123 (trace constituents), T-125 (trace constituents), M-126 (major constituents), N-38 (nutrients), N-39 (Nutrients), P-20 (precipitation-low ionic strength), and Hg-16 (mercury)--that were distributed in April 1993 to 175 laboratories registered in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data received from 131 of the laboratories were evaluated with respect to: overall laboratory performance and relative laboratory performance for each analyte in the 7 reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the seven standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Results of the U.S. Geological Survey's Analytical Evaluation Program for standard reference samples distributed in March 1999

USGS Publications Warehouse

Farrar, Jerry W.; Chleboun, Kimberly M.

1999-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for 8 standard reference samples -- T-157 (trace constituents), M-150 (major constituents), N-61 (nutrient constituents), N-62 (nutrient constituents), P-32 (low ionic strength constituents), GWT-5 (ground-water trace constituents), GWM- 4 (ground-water major constituents),and Hg-28 (mercury) -- that were distributed in March 1999 to 120 laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 111 of the laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the seven reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the 8 standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

[Urinary evaluations of drug consumption among workers having high risk of accident: technical difficulties, limits and possibilities of increasing efficacy of the law].

PubMed

D'Orso, M I; Grosso, D; Colli, M; Gironi, A; Riva, M A; Cesana, G

2012-01-01

Urinary evaluations of drug consumption among workers having high risk of accident became compulsory in Italian legislation few years ago. We report results of 322.110 single urinary drug detections carried out between 2008 and 2011 on 35.789 subjects. We verified technical difficulties arisen during laboratory detections and organizational difficulties evidenced by Occupational Doctors during collections of samples. We screened 701 positive samples (1.96%), mostly to Cannabinoids and Cocaine, verified using first and second level screening according to national law. Many patients referred regular or irregular use of medicines active on Central Nervous System frequently ignoring their collateral effects. After the evidence of a positive result, during a second medical visit, many workers referred assumption of "natural diet supplements" acquired not in traditional commercial distributors. In two cases we have had the possibility of analyzing these supplements which have shown the presence of law concentrations of drugs in their compositions.

Estrogen- and progesterone-receptor status in ECOG 2197: comparison of immunohistochemistry by local and central laboratories and quantitative reverse transcription polymerase chain reaction by central laboratory.

PubMed

Badve, Sunil S; Baehner, Frederick L; Gray, Robert P; Childs, Barrett H; Maddala, Tara; Liu, Mei-Lan; Rowley, Steve C; Shak, Steven; Perez, Edith A; Perez, Edith D; Shulman, Lawrence J; Martino, Silvana; Davidson, Nancy E; Sledge, George W; Goldstein, Lori J; Sparano, Joseph A

2008-05-20

Central and local laboratory concordance for hormone receptor measurement is therapeutically important. This study compares estrogen receptor (ER) and progesterone receptor (PR) measured by local laboratory immunohistochemistry (IHC), central IHC, and central reverse-transcriptase polymerase chain reaction (RT-PCR) using a proprietary 21-gene assay. A case-control sample of 776 breast cancer patients from Eastern Cooperative Oncology Group (ECOG) study E2197 was evaluated. Central IHC Allred score for ER and PR was obtained using tissue microarrays and 1D5 ER antibody and 636 PR antibody. Quantitative RT-PCR for ER and PR in whole sections was performed using the 21-gene assay. For ER, the concordance between local and central IHC was 90% (95% CI, 88% to 92%), between local IHC and central RT-PCR was 91% (95% CI, 89% to 93%), and between central IHC and central RT-PCR was 93% (95% CI, 91% to 95%). For PR, the concordance between local IHC and central IHC was 84% (95% CI, 82% to 87%), between local IHC and central RT-PCR was 88% (95% CI, 85% to 90%), and between central IHC and central RT-PCR was 90% (95% CI, 88% to 92%). Although concordance was high, IHC ER-negative cases that were RT-PCR positive were more common than IHC ER-positive cases that were RT-PCR negative. In ER-positive patients, ER expression by central IHC Allred score was marginally associated with recurrence (P = .091), and ER expression by central RT-PCR was significantly associated with recurrence (P = .014). However, recurrence score, which incorporates additional genes/pathways, was a highly significant predictor of recurrence (P < .0001). There is a high degree of concordance among local IHC, central IHC, and central RT-PCR by the proprietary gene assay for ER and PR status. Although ER expression is marginally associated with relapse in ER-positive patients treated with chemohormonal therapy, recurrence score is a highly significant predictor of recurrence.

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.

Centrally Determined Standardization of Flow Cytometry Methods Reduces Interlaboratory Variation in a Prospective Multicenter Study.

PubMed

Westera, Liset; van Viegen, Tanja; Jeyarajah, Jenny; Azad, Azar; Bilsborough, Janine; van den Brink, Gijs R; Cremer, Jonathan; Danese, Silvio; D'Haens, Geert; Eckmann, Lars; Faubion, William; Filice, Melissa; Korf, Hannelie; McGovern, Dermot; Panes, Julian; Salas, Azucena; Sandborn, William J; Silverberg, Mark S; Smith, Michelle I; Vermeire, Severine; Vetrano, Stefania; Shackelton, Lisa M; Stitt, Larry; Jairath, Vipul; Levesque, Barrett G; Spencer, David M; Feagan, Brian G; Vande Casteele, Niels

2017-11-02

Flow cytometry (FC) aids in characterization of cellular and molecular factors involved in pathologic immune responses. Although FC has potential to facilitate early drug development in inflammatory bowel disease, interlaboratory variability limits its use in multicenter trials. Standardization of methods may address this limitation. We compared variability in FC-aided quantitation of T-cell responses across international laboratories using three analytical strategies. Peripheral blood mononuclear cells (PBMCs) were isolated from three healthy donors, stimulated with phorbol 12-myristate 13-acetate and ionomycin at a central laboratory, fixed, frozen, and shipped to seven international laboratories. Permeabilization and staining was performed in triplicate at each laboratory using a common protocol and centrally provided reagents. Gating was performed using local gating with a local strategy (LGLS), local gating with a central strategy (LGCS), and central gating (CG). Median cell percentages were calculated across triplicates and donors, and reported for each condition and strategy. The coefficient of variation (CV) was calculated across laboratories. Between-strategy comparisons were made using a two-way analysis of variance adjusting for donor. Mean interlaboratory CV ranged from 1.8 to 102.1% depending on cell population and gating strategy (LGLS, 4.4-102.1%; LGCS, 10.9-65.6%; CG, 1.8-20.9%). Mean interlaboratory CV differed significantly across strategies and was consistently lower with CG. Central gating was the only strategy with mean CVs consistently lower than 25%, which is a proposed standard for pharmacodynamic and exploratory biomarker assays.

CSF Aβ1-42 - an excellent but complicated Alzheimer's biomarker - a route to standardisation.

PubMed

Kuhlmann, Julia; Andreasson, Ulf; Pannee, Josef; Bjerke, Maria; Portelius, Erik; Leinenbach, Andreas; Bittner, Tobias; Korecka, Magdalena; Jenkins, Rand G; Vanderstichele, Hugo; Stoops, Erik; Lewczuk, Piotr; Shaw, Leslie M; Zegers, Ingrid; Schimmel, Heinz; Zetterberg, Henrik; Blennow, Kaj

2017-04-01

The 42 amino acid form of amyloid β (Aβ 1 - 42 ) in cerebrospinal fluid (CSF) has been widely accepted as a central biomarker for Alzheimer's disease. Several immunoassays for CSF Aβ 1-42 are commercially available, but can suffer from between laboratory and batch-to-batch variability as well as lack of standardisation across assays. As a consequence, no general cut-off values have been established for a specific context of use (e.g., clinical diagnostics) and selection of individuals for enrolment in clinical trials (patient stratification) remains challenging. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has initiated a working group for CSF proteins (WG-CSF) to facilitate standardisation of CSF Aβ 1-42 measurement results. The efforts of the IFCC WG-CSF include the development of certified reference materials (CRMs) and reference measurement procedures (RMPs) for key biomarkers. Two candidate RMPs for quantification of Aβ 1-42 in CSF based on liquid chromatography tandem mass spectrometry have been developed and tested in two ring trials. Furthermore, two commutability studies including native CSF pools, artificial CSF and spiked materials have been completed. On the basis of these studies, human CSF pools containing only endogenous Aβ 1-42 at three concentrations were selected as the format for future CRMs that are now being processed. Copyright © 2016 Elsevier B.V. All rights reserved.

Multiple-layer compression-coated tablets: formulation and humidity studies of novel chewable amoxicillin/clavulanate tablet formulations.

PubMed

Wardrop, J; Jaber, A B; Ayres, J W

1998-08-01

The purpose of this study was to produce novel multiple-layer, compression-coated, chewable tablet formulations containing amoxicillin trihydrate, and clavulanic acid as potassium clavulanate, and to test in vitro dissolution characteristics and the effect of humidity stability compared to Augmentin chewable tablets as a reference. Double- and triple-layer tablets were manufactured on a laboratory scale by multiple-layer dry compression, and dissolution profiles of both active ingredients were determined. Tablets were subjected to stability evaluation in laboratory-scale humidity tanks maintained at constant humidity. Assay of content was determined by HPLC or UV spectroscopy. Physical characteristics of the powder mixture, such as angle of repose, and of tablets for hardness and friability, were also determined. Chewable tablets showed similar dissolution profiles in vitro for both active ingredients, compared to the marketed reference, Augmentin. The stability of clavulanic acid, but not amoxicillin, was increased in the novel triple or bilayer formulation. The tablets showed suitable friability, hardness, and angle of repose for starting materials to suggest that industrial scale-up is feasible. This approach to formulation of drugs containing multiple or moisture-sensitive ingredients has been shown to increase the stability of the central core drug without changing the dissolution pattern of the active ingredients. This formulation is expected to be bioequivalent in vivo based on these in vitro results.

Evaluation of GRCh38 and de novo haploid genome assemblies demonstrates the enduring quality of the reference assembly.

PubMed

Schneider, Valerie A; Graves-Lindsay, Tina; Howe, Kerstin; Bouk, Nathan; Chen, Hsiu-Chuan; Kitts, Paul A; Murphy, Terence D; Pruitt, Kim D; Thibaud-Nissen, Françoise; Albracht, Derek; Fulton, Robert S; Kremitzki, Milinn; Magrini, Vincent; Markovic, Chris; McGrath, Sean; Steinberg, Karyn Meltz; Auger, Kate; Chow, William; Collins, Joanna; Harden, Glenn; Hubbard, Timothy; Pelan, Sarah; Simpson, Jared T; Threadgold, Glen; Torrance, James; Wood, Jonathan M; Clarke, Laura; Koren, Sergey; Boitano, Matthew; Peluso, Paul; Li, Heng; Chin, Chen-Shan; Phillippy, Adam M; Durbin, Richard; Wilson, Richard K; Flicek, Paul; Eichler, Evan E; Church, Deanna M

2017-05-01

The human reference genome assembly plays a central role in nearly all aspects of today's basic and clinical research. GRCh38 is the first coordinate-changing assembly update since 2009; it reflects the resolution of roughly 1000 issues and encompasses modifications ranging from thousands of single base changes to megabase-scale path reorganizations, gap closures, and localization of previously orphaned sequences. We developed a new approach to sequence generation for targeted base updates and used data from new genome mapping technologies and single haplotype resources to identify and resolve larger assembly issues. For the first time, the reference assembly contains sequence-based representations for the centromeres. We also expanded the number of alternate loci to create a reference that provides a more robust representation of human population variation. We demonstrate that the updates render the reference an improved annotation substrate, alter read alignments in unchanged regions, and impact variant interpretation at clinically relevant loci. We additionally evaluated a collection of new de novo long-read haploid assemblies and conclude that although the new assemblies compare favorably to the reference with respect to continuity, error rate, and gene completeness, the reference still provides the best representation for complex genomic regions and coding sequences. We assert that the collected updates in GRCh38 make the newer assembly a more robust substrate for comprehensive analyses that will promote our understanding of human biology and advance our efforts to improve health. © 2017 Schneider et al.; Published by Cold Spring Harbor Laboratory Press.

Comparison of laboratory and ambulatory measures of central blood pressure and pulse wave reflection: hitting the target or missing the mark?

PubMed

Burns, Matthew J; Seed, Jeremy D; Incognito, Anthony V; Doherty, Connor J; Notay, Karambir; Millar, Philip J

2018-04-01

Prior studies demonstrating clinical significance of noninvasive estimates of central blood pressure (BP) and pulse wave reflection have relied primarily on discrete resting measures. The aim of this study was to compare central BP and pulse wave reflection measures sampled during a single resting laboratory visit against those obtained under ambulatory conditions. The secondary aim was to investigate the reproducibility of ambulatory central BP and pulse wave reflection measurements. Forty healthy participants (21 males; 24 ± 3 years) completed three measurements of brachial artery pulse wave analysis (Oscar 2 with SphygmoCor Inside) in the laboratory followed by 24 hours of ambulatory monitoring. Seventeen participants repeated the 24-hour ambulatory monitoring visit after at least 1 week. Ambulatory measures were divided into daytime (9 AM-9 PM), nighttime (1 AM-6 AM), and 24-hour periods. Compared with laboratory measurements, central systolic BP, augmentation pressure, and augmentation index (with and without heart rate normalization) were higher (all P < .01) during daytime and 24-hour periods but lower during the nighttime period (all P < .001). The drop in nighttime brachial systolic BP was larger than central systolic pressure (Δ -20 ± 6 vs. -15 ± 6 mm Hg; P < .0001). Repeat ambulatory measurements of central BP and pulse wave reflection displayed good-to-excellent intraclass correlation coefficients (r = 0.58-0.86; all P < .01), although measures of pulse wave reflection had higher coefficients of variation (14%-41%). The results highlight absolute differences in central BP and pulse wave reflection between discrete laboratory and ambulatory conditions. The use of ambulatory measures of central BP and pulse wave reflection warrant further investigation for clinical prognostic value. Copyright © 2018 American Heart Association. Published by Elsevier Inc. All rights reserved.

Instantaneous progression reference frame for calculating pelvis rotations: Reliable and anatomically-meaningful results independent of the direction of movement.

PubMed

Kainz, Hans; Lloyd, David G; Walsh, Henry P J; Carty, Christopher P

2016-05-01

In motion analysis, pelvis angles are conventionally calculated as the rotations between the pelvis and laboratory reference frame. This approach assumes that the participant's motion is along the anterior-posterior laboratory reference frame axis. When this assumption is violated interpretation of pelvis angels become problematic. In this paper a new approach for calculating pelvis angles based on the rotations between the pelvis and an instantaneous progression reference frame was introduced. At every time-point, the tangent to the trajectory of the midpoint of the pelvis projected into the horizontal plane of the laboratory reference frame was used to define the anterior-posterior axis of the instantaneous progression reference frame. This new approach combined with the rotation-obliquity-tilt rotation sequence was compared to the conventional approach using the rotation-obliquity-tilt and tilt-obliquity-rotation sequences. Four different movement tasks performed by eight healthy adults were analysed. The instantaneous progression reference frame approach was the only approach that showed reliable and anatomically meaningful results for all analysed movement tasks (mean root-mean-square-differences below 5°, differences in pelvis angles at pre-defined gait events below 10°). Both rotation sequences combined with the conventional approach led to unreliable results as soon as the participant's motion was not along the anterior-posterior laboratory axis (mean root-mean-square-differences up to 30°, differences in pelvis angles at pre-defined gait events up to 45°). The instantaneous progression reference frame approach enables the gait analysis community to analysis pelvis angles for movements that do not follow the anterior-posterior axis of the laboratory reference frame. Copyright © 2016 Elsevier B.V. All rights reserved.

Comparison of microbiological diagnosis of urinary tract infection in young children by routine health service laboratories and a research laboratory: Diagnostic cohort study.

PubMed

Birnie, Kate; Hay, Alastair D; Wootton, Mandy; Howe, Robin; MacGowan, Alasdair; Whiting, Penny; Lawton, Michael; Delaney, Brendan; Downing, Harriet; Dudley, Jan; Hollingworth, William; Lisles, Catherine; Little, Paul; O'Brien, Kathryn; Pickles, Timothy; Rumsby, Kate; Thomas-Jones, Emma; Van der Voort, Judith; Waldron, Cherry-Ann; Harman, Kim; Hood, Kerenza; Butler, Christopher C; Sterne, Jonathan A C

2017-01-01

To compare the validity of diagnosis of urinary tract infection (UTI) through urine culture between samples processed in routine health service laboratories and those processed in a research laboratory. We conducted a prospective diagnostic cohort study in 4808 acutely ill children aged <5 years attending UK primary health care. UTI, defined as pure/predominant growth ≥105 CFU/mL of a uropathogen (the reference standard), was diagnosed at routine health service laboratories and a central research laboratory by culture of urine samples. We calculated areas under the receiver-operator curve (AUC) for UTI predicted by pre-specified symptoms, signs and dipstick test results (the "index test"), separately according to whether samples were obtained by clean catch or nappy (diaper) pads. 251 (5.2%) and 88 (1.8%) children were classified as UTI positive by health service and research laboratories respectively. Agreement between laboratories was moderate (kappa = 0.36; 95% confidence interval [CI] 0.29, 0.43), and better for clean catch (0.54; 0.45, 0.63) than nappy pad samples (0.20; 0.12, 0.28). In clean catch samples, the AUC was lower for health service laboratories (AUC = 0.75; 95% CI 0.69, 0.80) than the research laboratory (0.86; 0.79, 0.92). Values of AUC were lower in nappy pad samples (0.65 [0.61, 0.70] and 0.79 [0.70, 0.88] for health service and research laboratory positivity, respectively) than clean catch samples. The agreement of microbiological diagnosis of UTI comparing routine health service laboratories with a research laboratory was moderate for clean catch samples and poor for nappy pad samples and reliability is lower for nappy pad than for clean catch samples. Positive results from the research laboratory appear more likely to reflect real UTIs than those from routine health service laboratories, many of which (particularly from nappy pad samples) could be due to contamination. Health service laboratories should consider adopting procedures used in the research laboratory for paediatric urine samples. Primary care clinicians should try to obtain clean catch samples, even in very young children.

Quality assurance of reference standards from nine European solar-ultraviolet monitoring laboratories.

PubMed

Gröbner, Julian; Rembges, Diana; Bais, Alkiviadis F; Blumthaler, Mario; Cabot, Thierry; Josefsson, Weine; Koskela, Tapani; Thorseth, Trond M; Webb, Ann R; Wester, Ulf

2002-07-20

A program for quality assurance of reference standards has been initiated among nine solar-UV monitoring laboratories. By means of a traveling lamp package that comprises several 1000-W ANSI code DXW-type quartz-halogen lamps, a 0.1-ohm shunt, and a 6-1/2 digit voltmeter, the irradiance scales used by the nine laboratories were compared with one another; a relative uncertainty of 1.2% was found. The comparison of 15 reference standards yielded differences of as much as 9%; the average difference was less than 3%.

Comparative analytical costs of central laboratory glucose and bedside glucose testing: a College of American Pathologists Q-Probes study.

PubMed

Howanitz, Peter J; Jones, Bruce A

2004-07-01

One of the major attributes of laboratory testing is cost. Although fully automated central laboratory glucose testing and semiautomated bedside glucose testing (BGT) are performed at most institutions, rigorous determinations of interinstitutional comparative costs have not been performed. To compare interinstitutional analytical costs of central laboratory glucose testing and BGT and to provide suggestions for improvement. Participants completed a demographic form about their institutional glucose monitoring practices. They also collected information about the costs of central laboratory glucose testing, BGT at a high-volume testing site, and BGT at a low-volume testing site, including specified cost variables for labor, reagents, and instruments. A total of 445 institutions enrolled in the College of American Pathologists Q-Probes program. Median cost per glucose test at 3 testing sites. The median (10th-90th percentile range) costs per glucose test were 1.18 dollars (5.59 dollars-0.36 dollars), 1.96 dollars (9.51 dollars-0.77 dollars), and 4.66 dollars (27.54 dollars-1.02 dollars) for central laboratory, high-volume BGT sites, and low-volume BGT sites, respectively. The largest percentages of the cost per test were for labor (59.3%, 72.7%, and 85.8%), followed by supplies (27.2%, 27.3%, and 13.4%) and equipment (2.1%, 0.0%, and 0.0%) for the 3 sites, respectively. The median number of patient specimens per month at the high-volume BGT sites was 625 compared to 30 at the low-volume BGT sites. Most participants did not include labor, instrument maintenance, competency assessment, or oversight in their BGT estimated costs until required to do so for the study. Analytical costs per glucose test were lower for central laboratory glucose testing than for BGT, which, in turn, was highly variable and dependent on volume. Data that would be used for financial justification for BGT were widely aberrant and in need of improvement.

Validation of a motor activity system by a robotically controlled vehicle and using standard reference compounds.

PubMed

Patterson, John P; Markgraf, Carrie G; Cirino, Maria; Bass, Alan S

2005-01-01

A series of experiments were undertaken to evaluate the accuracy, precision, specificity, and sensitivity of an automated, infrared photo beam-based open field motor activity system, the MotorMonitor v. 4.01, Hamilton-Kinder, LLC, for use in a good laboratory practices (GLP) Safety Pharmacology laboratory. This evaluation consisted of two phases: (1) system validation, employing known inputs using the EM-100 Controller Photo Beam Validation System, a robotically controlled vehicle representing a rodent and (2) biologic validation, employing groups of rats treated with the standard pharmacologic agents diazepam or D-amphetamine. The MotorMonitor's parameters that described the open-field activity of a subject were: basic movements, total distance, fine movements, x/y horizontal ambulations, rearing, and total rest time. These measurements were evaluated over a number of zones within each enclosure. System validation with the EM-100 Controller Photo Beam Validation System showed that all the parameters accurately and precisely measured what they were intended to measure, with the exception of fine movements and x/y ambulations. Biologic validation using the central nervous system depressant diazepam at 1, 2, or 5 mg/kg, i.p. produced the expected dose-dependent reduction in rat motor activity. In contrast, the central nervous system stimulant D-amphetamine produced the expected increases in rat motor activity at 0.1 and 1 mg/kg, i.p, demonstrating the specificity and sensitivity of the system. Taken together, these studies of the accuracy, precision, specificity, and sensitivity show the importance of both system and biologic validation in the evaluation of an automated open field motor activity system for use in a GLP compliant laboratory.

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.

[The hygienic situation of the central drinking water supply in the former East Germany--an evaluation of the annual reports on water hygiene from 1984 to 1989].

PubMed

Schlosser, F U; Schulze, E

1991-12-01

In the former GDR an annual report on the situation in the field of communal hygiene had to be elaborated and submitted to the minister of public health. One part of this was the report on the hygienic situation in water supply, worked out by the Reference Laboratory for Water Hygiene in Bad Elster. After the political changes in autumn 1989 it became possible to analyse these reports as a whole. In this paper the reports from 1984 to 1989 are interpreted. The results of the laboratory measurements and field controls by the State Sanitary Inspectorates are shown in 17 graphics and compared to the bacteriological and chemical limits in drinking water standards. Special issue is drawn on the estimation of the number of inhabitants concerned by reduced drinking-water quality or any hazardous situations. The special problems of the different districts are compared in some graphics. The hygienic safety of the central drinking-water supply units is assessed basing on the results of the field controls by the State Sanitary Inspectorate. The Sanitation of the central drinking-water supply facilities in the new federal countries of the FRG is connected with the solution of a variety of technological problems, particularly the improvement of the water treatment techniques and the restoration of the pipe systems. The use of surface waters from extremely polluted rivers generates a high hygienic risk and requires the sanitation of the rivers. The high number of existing protection zones in the catchment areas for drinking-water is a valuable precondition to ensure the hygienic safety of the drinking-water supply in the new federal countries.

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.

75 FR 73128 - Certain Printing and Imaging Devices and Components Thereof; Notice of Commission Determination...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-29

...'' include any line extending parallel to the central axis of the roller? Or, does this refer to the central... ``a longitudinal direction'' can include any line extending parallel to the central axis of the roller...) The finding that the Taylor reference (``A Telerobot on the World Wide Web'') (RX-281) does not...

GFT centrality: A new node importance measure for complex networks

NASA Astrophysics Data System (ADS)

Singh, Rahul; Chakraborty, Abhishek; Manoj, B. S.

2017-12-01

Identifying central nodes is very crucial to design efficient communication networks or to recognize key individuals of a social network. In this paper, we introduce Graph Fourier Transform Centrality (GFT-C), a metric that incorporates local as well as global characteristics of a node, to quantify the importance of a node in a complex network. GFT-C of a reference node in a network is estimated from the GFT coefficients derived from the importance signal of the reference node. Our study reveals the superiority of GFT-C over traditional centralities such as degree centrality, betweenness centrality, closeness centrality, eigenvector centrality, and Google PageRank centrality, in the context of various arbitrary and real-world networks with different degree-degree correlations.

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

PubMed

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

2016-01-01

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

Quality-assurance results for routine water analyses in U.S. Geological Survey laboratories, water year 1998

USGS Publications Warehouse

Ludtke, Amy S.; Woodworth, Mark T.; Marsh, Philip S.

2000-01-01

The U.S. Geological Survey operates a quality-assurance program based on the analyses of reference samples for two laboratories: the National Water Quality Laboratory and the Quality of Water Service Unit. Reference samples that contain selected inorganic, nutrient, and low-level constituents are prepared and submitted to the laboratory as disguised routine samples. The program goal is to estimate precision and bias for as many analytical methods offered by the participating laboratories as possible. Blind reference samples typically are submitted at a rate of 2 to 5 percent of the annual environmental-sample load for each constituent. The samples are distributed to the laboratories throughout the year. The reference samples are subject to the identical laboratory handling, processing, and analytical procedures as those applied to environmental samples and, therefore, have been used as an independent source to verify bias and precision of laboratory analytical methods and ambient water-quality measurements. The results are stored permanently in the National Water Information System and the Blind Sample Project's data base. During water year 1998, 95 analytical procedures were evaluated at the National Water Quality Laboratory and 63 analytical procedures were evaluated at the Quality of Water Service Unit. An overall evaluation of the inorganic and low-level constituent data for water year 1998 indicated 77 of 78 analytical procedures at the National Water Quality Laboratory met the criteria for precision. Silver (dissolved, inductively coupled plasma-mass spectrometry) was determined to be imprecise. Five of 78 analytical procedures showed bias throughout the range of reference samples: chromium (dissolved, inductively coupled plasma-atomic emission spectrometry), dissolved solids (dissolved, gravimetric), lithium (dissolved, inductively coupled plasma-atomic emission spectrometry), silver (dissolved, inductively coupled plasma-mass spectrometry), and zinc (dissolved, inductively coupled plasma-mass spectrometry). At the National Water Quality Laboratory during water year 1998, lack of precision was indicated for 2 of 17 nutrient procedures: ammonia as nitrogen (dissolved, colorimetric) and orthophosphate as phosphorus (dissolved, colorimetric). Bias was indicated throughout the reference sample range for ammonia as nitrogen (dissolved, colorimetric, low level) and nitrate plus nitrite as nitrogen (dissolved, colorimetric, low level). All analytical procedures tested at the Quality of Water Service Unit during water year 1998 met the criteria for precision. One of the 63 analytical procedures indicated a bias throughout the range of reference samples: aluminum (whole-water recoverable, inductively coupled plasma-atomic emission spectrometry, trace).

In vitro vaccine potency testing: a proposal for reducing animal use for requalification testing.

PubMed

Brown, K; Stokes, W

2012-01-01

This paper proposes a program under which the use of animals for requalification of in vitro potency tests could be eliminated. Standard References (USDA/CVB nomenclature) would be developed, characterized, stored and monitored by selected reference laboratories worldwide. These laboratories would employ scientists skilled in protein and glycoprotein chemistry and equipped with state-of-the-art instruments for required analyses. After Standard References are established, the reference laboratories would provide them to the animal health industry as "gold standards". Companies would then establish and validate a correlation between the Standard Reference and the company Master Reference (USDA/CVB nomenclature) using an internal in vitro assay. After this correlation is established, the company could use the Standard References for qualifying, monitoring and requalifying company Master References without the use of animals. Such a program would eliminate the need for animals for requalification of Master References and the need for each company to develop and validate a battery of Master Reference Monitoring assays. It would also provide advantages in terms of reduced costs and reduced time for requalification testing. As such it would provide a strong incentive for companies to develop and use in vitro assays for potency testing.

Manganese recycling in the United States in 1998

USGS Publications Warehouse

Jones, Thomas S.

2003-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for six standard reference samples -- T-163 (trace constituents), M-156 (major constituents), N-67 (nutrient constituents), N-68 (nutrient constituents), P-35 (low ionic strength constituents), and Hg-31 (mercury) -- that were distributed in October 2000 to 126 laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 122 of the laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Analysis of on-line clinical laboratory manuals and practical recommendations.

PubMed

Beckwith, Bruce; Schwartz, Robert; Pantanowitz, Liron

2004-04-01

On-line clinical laboratory manuals are a valuable resource for medical professionals. To our knowledge, no recommendations currently exist for their content or design. To analyze publicly accessible on-line clinical laboratory manuals and to propose guidelines for their content. We conducted an Internet search for clinical laboratory manuals written in English with individual test listings. Four individual test listings in each manual were evaluated for 16 data elements, including sample requirements, test methodology, units of measure, reference range, and critical values. Web sites were also evaluated for supplementary information and search functions. We identified 48 on-line laboratory manuals, including 24 academic or community hospital laboratories and 24 commercial or reference laboratories. All manuals had search engines and/or test indices. No single manual contained all 16 data elements evaluated. An average of 8.9 (56%) elements were present (range, 4-14). Basic sample requirements (specimen and volume needed) were the elements most commonly present (98% of manuals). The frequency of the remaining data elements varied from 10% to 90%. On-line clinical laboratory manuals originate from both hospital and commercial laboratories. While most manuals were user-friendly and contained adequate specimen-collection information, other important elements, such as reference ranges, were frequently absent. To ensure that clinical laboratory manuals are of maximal utility, we propose the following 13 data elements be included in individual test listings: test name, synonyms, test description, test methodology, sample requirements, volume requirements, collection guidelines, transport guidelines, units of measure, reference range, critical values, test availability, and date of latest revision.

[The requirements of standard and conditions of interchangeability of medical articles].

PubMed

Men'shikov, V V; Lukicheva, T I

2013-11-01

The article deals with possibility to apply specific approaches under evaluation of interchangeability of medical articles for laboratory analysis. The development of standardized analytical technologies of laboratory medicine and formulation of requirements of standards addressed to manufacturers of medical articles the clinically validated requirements are to be followed. These requirements include sensitivity and specificity of techniques, accuracy and precision of research results, stability of reagents' quality in particular conditions of their transportation and storage. The validity of requirements formulated in standards and addressed to manufacturers of medical articles can be proved using reference system, which includes master forms and standard samples, reference techniques and reference laboratories. This approach is supported by data of evaluation of testing systems for measurement of level of thyrotrophic hormone, thyroid hormones and glycated hemoglobin HB A1c. The versions of testing systems can be considered as interchangeable only in case of results corresponding to the results of reference technique and comparable with them. In case of absence of functioning reference system the possibilities of the Joined committee of traceability in laboratory medicine make it possible for manufacturers of reagent sets to apply the certified reference materials under development of manufacturing of sets for large listing of analytes.

42 CFR 493.1264 - Standard: Parasitology.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Systems § 493.1264 Standard: Parasitology. (a) The laboratory must have available a reference collection... these references in the laboratory for appropriate comparison with diagnostic specimens. (b) The...

Early Predictors of Fever in Patients with Aneurysmal Subarachnoid Hemorrhage.

PubMed

Rocha Ferreira da Silva, Ivan; Rodriguez de Freitas, Gabriel

2016-12-01

Fever is commonly observed in patients who have had aneurysmal subarachnoid hemorrhage (SAH), and it has been associated with the occurrence of delayed cerebral ischemia and worse outcomes in previous studies. Frequently, fever is not the result of bacterial infections, and distinction between infection-related fever and fever secondary to brain injury (also referred as central fever) can be challenging. The current study aimed to identify risk factors on admission for the development of central fever in patients with SAH. Databank analysis was performed using information from demographic data (age, gender), imaging (transcranial Doppler ultrasound, computed tomography, and cerebral angiogram), laboratory (white blood cell count, hemoglobin, renal function, and electrolytes), and clinical assessment (Hunt-Hess and modified Fisher scales on admission, occurrence of fever). A multivariate logistic regression model was created. Of 55 patients, 32 developed fever during the first 7 days of hospital stay (58%). None of the patients had identifiable bacterial infections during their first week in the neurocritical care unit. Hunt-Hess scale >2 and leukocytosis on admission were associated to the development of central fever, even after correction in a logistic regression model. Leukocytosis and a poor neurologic examination on admission might help predict which subset of patients with SAH are at higher risk of developing central fever early in their hospital stay. Copyright © 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Centrally Determined Standardization of Flow Cytometry Methods Reduces Interlaboratory Variation in a Prospective Multicenter Study

PubMed Central

Westera, Liset; van Viegen, Tanja; Jeyarajah, Jenny; Azad, Azar; Bilsborough, Janine; van den Brink, Gijs R; Cremer, Jonathan; Danese, Silvio; D'Haens, Geert; Eckmann, Lars; Faubion, William; Filice, Melissa; Korf, Hannelie; McGovern, Dermot; Panes, Julian; Salas, Azucena; Sandborn, William J; Silverberg, Mark S; Smith, Michelle I; Vermeire, Severine; Vetrano, Stefania; Shackelton, Lisa M; Stitt, Larry; Jairath, Vipul; Levesque, Barrett G; Spencer, David M; Feagan, Brian G; Vande Casteele, Niels

2017-01-01

Objectives: Flow cytometry (FC) aids in characterization of cellular and molecular factors involved in pathologic immune responses. Although FC has potential to facilitate early drug development in inflammatory bowel disease, interlaboratory variability limits its use in multicenter trials. Standardization of methods may address this limitation. We compared variability in FC-aided quantitation of T-cell responses across international laboratories using three analytical strategies. Methods: Peripheral blood mononuclear cells (PBMCs) were isolated from three healthy donors, stimulated with phorbol 12-myristate 13-acetate and ionomycin at a central laboratory, fixed, frozen, and shipped to seven international laboratories. Permeabilization and staining was performed in triplicate at each laboratory using a common protocol and centrally provided reagents. Gating was performed using local gating with a local strategy (LGLS), local gating with a central strategy (LGCS), and central gating (CG). Median cell percentages were calculated across triplicates and donors, and reported for each condition and strategy. The coefficient of variation (CV) was calculated across laboratories. Between-strategy comparisons were made using a two-way analysis of variance adjusting for donor. Results: Mean interlaboratory CV ranged from 1.8 to 102.1% depending on cell population and gating strategy (LGLS, 4.4–102.1% LGCS, 10.9–65.6% CG, 1.8–20.9%). Mean interlaboratory CV differed significantly across strategies and was consistently lower with CG. Conclusions: Central gating was the only strategy with mean CVs consistently lower than 25%, which is a proposed standard for pharmacodynamic and exploratory biomarker assays. PMID:29095427

Results of the U.S. Geological Survey's Analytical Evaluation Program for standard reference samples: T-155 (trace constituents), M-148 (major constituents), N-59 (nutrient constituents), N-60 (nutrient constituents), P-31 (low ionic strength constituents), GWT-4 (ground-water trace constituents) and Hg-27 (Mercury) distributed in September 1998

USGS Publications Warehouse

Farrar, Jerry W.

1999-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for seven standard reference samples -- T-155 (trace constituents), M-148 (major constituents), N-59 (nutrient constituents), N-60 (nutrient constituents), P-31 (low ionic strength constituents), GWT-4 (ground-water trace constituents), and Hg- 27 (mercury) -- which were distributed in September 1998 to 162 laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 136 of the laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the seven reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the seven standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Report on the U.S. Geological Survey's evaluation program for standard reference samples distributed in October 1993 : T-127 (trace constituents), M-128 (major constituents), N-40 (nutrients), N-41 (nutrients), P-21 (low ionic strength), Hg-17 (mercury), AMW-3 (acid mine water), and WW-1 (whole water)

USGS Publications Warehouse

Long, H.K.; Farrar, J.W.

1994-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for eight standard reference samples--T-127 (trace constituents), M-128 (major constituents), N-40 (nutrients), N-41 (nutrients), P-21 (low ionic strength), Hg-17 (mercury), AMW-3 (acid mine water), and WW-1 (whole water)--that were distributed in October 1993 to 158 laboratories registered in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 145 of the laboratories were evaluated with respect to: overall laboratory performance and relative laboratory performance for each analyte in the eight reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the eight standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Report on the U.S. Geological Survey's evaluation program for standard reference samples distributed in October 1994 : T-131 (trace constituents), T-133 (trace constituents), M-132 (major constituents), N-43 (nutrients), N-44 (nutrients), P-23 (low ionic strength) and Hg-19 (mercury)

USGS Publications Warehouse

Long, H. Keith; Farrar, Jerry W.

1995-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for 7 standard reference samples--T-131 (trace constituents), T-133 (trace constituents), M-132 (major constituents), N-43 (nutrients), N-44 (nutrients), P-23 (low ionic strength), and Hg-19 (mercury). The samples were distributed in October 1994 to 131 laboratories registered in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 121 of the laboratories were evaluated with respect to: overall laboratory performance and relative laboratory performance for each analyte in the seven reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the seven standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Rapid, comprehensive, and affordable mycobacterial diagnosis with whole-genome sequencing: a prospective study

PubMed Central

Pankhurst, Louise J; del Ojo Elias, Carlos; Votintseva, Antonina A; Walker, Timothy M; Cole, Kevin; Davies, Jim; Fermont, Jilles M; Gascoyne-Binzi, Deborah M; Kohl, Thomas A; Kong, Clare; Lemaitre, Nadine; Niemann, Stefan; Paul, John; Rogers, Thomas R; Roycroft, Emma; Smith, E Grace; Supply, Philip; Tang, Patrick; Wilcox, Mark H; Wordsworth, Sarah; Wyllie, David; Xu, Li; Crook, Derrick W

2016-01-01

Summary Background Slow and cumbersome laboratory diagnostics for Mycobacterium tuberculosis complex (MTBC) risk delayed treatment and poor patient outcomes. Whole-genome sequencing (WGS) could potentially provide a rapid and comprehensive diagnostic solution. In this prospective study, we compare real-time WGS with routine MTBC diagnostic workflows. Methods We compared sequencing mycobacteria from all newly positive liquid cultures with routine laboratory diagnostic workflows across eight laboratories in Europe and North America for diagnostic accuracy, processing times, and cost between Sept 6, 2013, and April 14, 2014. We sequenced specimens once using local Illumina MiSeq platforms and processed data centrally using a semi-automated bioinformatics pipeline. We identified species or complex using gene presence or absence, predicted drug susceptibilities from resistance-conferring mutations identified from reference-mapped MTBC genomes, and calculated genetic distance to previously sequenced UK MTBC isolates to detect outbreaks. WGS data processing and analysis was done by staff masked to routine reference laboratory and clinical results. We also did a microcosting analysis to assess the financial viability of WGS-based diagnostics. Findings Compared with routine results, WGS predicted species with 93% (95% CI 90–96; 322 of 345 specimens; 356 mycobacteria specimens submitted) accuracy and drug susceptibility also with 93% (91–95; 628 of 672 specimens; 168 MTBC specimens identified) accuracy, with one sequencing attempt. WGS linked 15 (16% [95% CI 10–26]) of 91 UK patients to an outbreak. WGS diagnosed a case of multidrug-resistant tuberculosis before routine diagnosis was completed and discovered a new multidrug-resistant tuberculosis cluster. Full WGS diagnostics could be generated in a median of 9 days (IQR 6–10), a median of 21 days (IQR 14–32) faster than final reference laboratory reports were produced (median of 31 days [IQR 21–44]), at a cost of £481 per culture-positive specimen, whereas routine diagnosis costs £518, equating to a WGS-based diagnosis cost that is 7% cheaper annually than are present diagnostic workflows. Interpretation We have shown that WGS has a scalable, rapid turnaround, and is a financially feasible method for full MTBC diagnostics. Continued improvements to mycobacterial processing, bioinformatics, and analysis will improve the accuracy, speed, and scope of WGS-based diagnosis. Funding National Institute for Health Research, Department of Health, Wellcome Trust, British Colombia Centre for Disease Control Foundation for Population and Public Health, Department of Clinical Microbiology, Trinity College Dublin. PMID:26669893

Interlaboratory comparison of reference materials for nitrogen-isotope-ratio measurements

USGS Publications Warehouse

Böhlke, John Karl; Coplen, Tyler B.

1995-01-01

Aliquots of seven different reference materials were distributed for an interlaboratory comparison of stable nitrogen-isotope-ratio measurements. Results from 15 laboratories were compiled and evaluated selectively to yield provisional values of 515N for each material, i, with respect to atmospheric N2 (o1SN,7air). The 515N values reported by the different laboratories are correlated in such a way that some of the major discrepancies may be removed by normalization (/. e., by altering the length of the ô N scale for each laboratory by an amount defined by local measurements of reference materials with extreme values).

The Pitfalls of Companion Diagnostics: Evaluation of Discordant EGFR Mutation Results from a Clinical Laboratory and a Central Laboratory.

PubMed

Turner, Scott A; Peterson, Jason D; Pettus, Jason R; de Abreu, Francine B; Amos, Christopher I; Dragnev, Konstantin H; Tsongalis, Gregory J

2016-05-01

Accurate identification of somatic mutations in formalin-fixed, paraffin-embedded tumor tissue is required for enrollment into clinical trials for many novel targeted therapeutics, including trials requiring EGFR mutation status in non-small-cell lung carcinomas. Central clinical trial laboratories contracted to perform this analysis typically rely on US Food and Drug Administration-approved targeted assays to identify these mutations. We present two cases in which central laboratories inaccurately reported EGFR mutation status because of improper identification and isolation of tumor material and failure to accurately report assay limitations, resulting in enrollment denial. Such cases highlight the need for increased awareness by clinical trials of the limitation of these US Food and Drug Administration-approved assays and the necessity for a mechanism to reevaluate discordant results by alternative laboratory-developed procedures, including clinical next-generation sequencing. Copyright © 2016 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

Development of a candidate reference material for adventitious virus detection in vaccine and biologicals manufacturing by deep sequencing

PubMed Central

Mee, Edward T.; Preston, Mark D.; Minor, Philip D.; Schepelmann, Silke; Huang, Xuening; Nguyen, Jenny; Wall, David; Hargrove, Stacey; Fu, Thomas; Xu, George; Li, Li; Cote, Colette; Delwart, Eric; Li, Linlin; Hewlett, Indira; Simonyan, Vahan; Ragupathy, Viswanath; Alin, Voskanian-Kordi; Mermod, Nicolas; Hill, Christiane; Ottenwälder, Birgit; Richter, Daniel C.; Tehrani, Arman; Jacqueline, Weber-Lehmann; Cassart, Jean-Pol; Letellier, Carine; Vandeputte, Olivier; Ruelle, Jean-Louis; Deyati, Avisek; La Neve, Fabio; Modena, Chiara; Mee, Edward; Schepelmann, Silke; Preston, Mark; Minor, Philip; Eloit, Marc; Muth, Erika; Lamamy, Arnaud; Jagorel, Florence; Cheval, Justine; Anscombe, Catherine; Misra, Raju; Wooldridge, David; Gharbia, Saheer; Rose, Graham; Ng, Siemon H.S.; Charlebois, Robert L.; Gisonni-Lex, Lucy; Mallet, Laurent; Dorange, Fabien; Chiu, Charles; Naccache, Samia; Kellam, Paul; van der Hoek, Lia; Cotten, Matt; Mitchell, Christine; Baier, Brian S.; Sun, Wenping; Malicki, Heather D.

2016-01-01

Background Unbiased deep sequencing offers the potential for improved adventitious virus screening in vaccines and biotherapeutics. Successful implementation of such assays will require appropriate control materials to confirm assay performance and sensitivity. Methods A common reference material containing 25 target viruses was produced and 16 laboratories were invited to process it using their preferred adventitious virus detection assay. Results Fifteen laboratories returned results, obtained using a wide range of wet-lab and informatics methods. Six of 25 target viruses were detected by all laboratories, with the remaining viruses detected by 4–14 laboratories. Six non-target viruses were detected by three or more laboratories. Conclusion The study demonstrated that a wide range of methods are currently used for adventitious virus detection screening in biological products by deep sequencing and that they can yield significantly different results. This underscores the need for common reference materials to ensure satisfactory assay performance and enable comparisons between laboratories. PMID:26709640

Chemical mutagenesis in laboratory mammals. A bibliography on the effects of chemicals on germ cells

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

Von Halle, E.S.

1973-09-01

A list of references is presented on chemical mutagenesis in laboratory mammals. The references relate primarily to chemical effects on germ cells. Only references to the use of chemicals or chemicals and radiation are included. The publication includes a citation index, agent index, chemical abstracts registry number index, organism index, KWIC index, author index, and first author index. (ERB)

Resident training in point-of-care testing.

PubMed

Campbell, Sheldon; Howanitz, Peter J

2007-06-01

Although central laboratory testing has been the norm for the last few decades and point-of-care testing (POCT) is considered an emerging area, physicians were performing POCT long before the existence of central laboratory testing. As medical directors of POCT programs, pathologists need the basic knowledge and skills associated with directing laboratory-based testing programs as well as additional knowledge and skills about testing at the point of care. Although the essential elements of quality testing are the same for laboratory-based and POCT, the enormous variety of settings, technologies, and workers involved present unique challenges.

Identification of phlebotomine sand flies using one MALDI-TOF MS reference database and two mass spectrometer systems.

PubMed

Mathis, Alexander; Depaquit, Jérôme; Dvořák, Vit; Tuten, Holly; Bañuls, Anne-Laure; Halada, Petr; Zapata, Sonia; Lehrter, Véronique; Hlavačková, Kristýna; Prudhomme, Jorian; Volf, Petr; Sereno, Denis; Kaufmann, Christian; Pflüger, Valentin; Schaffner, Francis

2015-05-10

Rapid, accurate and high-throughput identification of vector arthropods is of paramount importance in surveillance programmes that are becoming more common due to the changing geographic occurrence and extent of many arthropod-borne diseases. Protein profiling by MALDI-TOF mass spectrometry fulfils these requirements for identification, and reference databases have recently been established for several vector taxa, mostly with specimens from laboratory colonies. We established and validated a reference database containing 20 phlebotomine sand fly (Diptera: Psychodidae, Phlebotominae) species by using specimens from colonies or field-collections that had been stored for various periods of time. Identical biomarker mass patterns ('superspectra') were obtained with colony- or field-derived specimens of the same species. In the validation study, high quality spectra (i.e. more than 30 evaluable masses) were obtained with all fresh insects from colonies, and with 55/59 insects deep-frozen (liquid nitrogen/-80 °C) for up to 25 years. In contrast, only 36/52 specimens stored in ethanol could be identified. This resulted in an overall sensitivity of 87 % (140/161); specificity was 100 %. Duration of storage impaired data counts in the high mass range, and thus cluster analyses of closely related specimens might reflect their storage conditions rather than phenotypic distinctness. A major drawback of MALDI-TOF MS is the restricted availability of in-house databases and the fact that mass spectrometers from 2 companies (Bruker, Shimadzu) are widely being used. We have analysed fingerprints of phlebotomine sand flies obtained by automatic routine procedure on a Bruker instrument by using our database and the software established on a Shimadzu system. The sensitivity with 312 specimens from 8 sand fly species from laboratory colonies when evaluating only high quality spectra was 98.3 %; the specificity was 100 %. The corresponding diagnostic values with 55 field-collected specimens from 4 species were 94.7 % and 97.4 %, respectively. A centralized high-quality database (created by expert taxonomists and experienced users of mass spectrometers) that is easily amenable to customer-oriented identification services is a highly desirable resource. As shown in the present work, spectra obtained from different specimens with different instruments can be analysed using a centralized database, which should be available in the near future via an online platform in a cost-efficient manner.

[Laboratory accreditation and proficiency testing].

PubMed

Kuwa, Katsuhiko

2003-05-01

ISO/TC 212 covering clinical laboratory testing and in vitro diagnostic test systems will issue the international standard for medical laboratory quality and competence requirements, ISO 15189. This standard is based on the ISO/IEC 17025, general requirements for competence of testing and calibration laboratories and ISO 9001, quality management systems-requirements. Clinical laboratory services are essential to patient care and therefore should be available to meet the needs of all patients and clinical personnel responsible for human health care. If a laboratory seeks accreditation, it should select an accreditation body that operates according to this international standard and in a manner which takes into account the particular requirements of clinical laboratories. Proficiency testing should be available to evaluate the calibration laboratories and reference measurement laboratories in clinical medicine. Reference measurement procedures should be of precise and the analytical principle of measurement applied should ensure reliability. We should be prepared to establish a quality management system and proficiency testing in clinical laboratories.

2015 Annual Wastewater Reuse Report for the Idaho National Laboratory Site’s Central Facilities Area Sewage Treatment Plant

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

Lewis, Michael George

This report describes conditions, as required by the state of Idaho Wastewater Reuse Permit (#LA-000141-03), for the wastewater land application site at the Idaho National Laboratory Site’s Central Facilities Area Sewage Treatment Plant from November 1, 2014, through October 31, 2015.

Making War Work for Industry: The United Alkali Company's Central Laboratory During World War One.

PubMed

Reed, Peter

2015-02-01

The creation of the Central Laboratory immediately after the United Alkali Company (UAC) was formed in 1890, by amalgamating the Leblanc alkali works in Britain, brought high expectations of repositioning the company by replacing its obsolete Leblanc process plant and expanding its range of chemical products. By 1914, UAC had struggled with few exceptions to adopt new technologies and processes and was still reliant on the Leblanc process. From 1914, the Government would rely heavily on its contribution to the war effort. As a major heavy-chemical manufacturer, UAC produced chemicals for explosives and warfare gases, while also trying to maintain production of many essential chemicals including fertilisers for homeland consumption. UAC's wartime effort was led by the Central Laboratory, working closely with the recently established Engineer's Department to develop new process pathways, build new plant, adapt existing plant, and produce the contracted quantities, all as quickly as possible to meet the changing battlefield demands. This article explores how wartime conditions and demands provided the stimulus for the Central Laboratory's crucial R&D work during World War One.

Dominance of international 'high-risk clones' among metallo-β-lactamase-producing Pseudomonas aeruginosa in the UK.

PubMed

Wright, Laura L; Turton, Jane F; Livermore, David M; Hopkins, Katie L; Woodford, Neil

2015-01-01

Carbapenem-resistant isolates of Pseudomonas aeruginosa producing metallo-β-lactamases (MBLs) are increasingly reported worldwide and often belong to particular 'high-risk clones'. This study aimed to characterize a comprehensive collection of MBL-producing P. aeruginosa isolates referred to the UK national reference laboratory from multiple UK laboratories over a 10 year period. Isolates were referred to the UK national reference laboratory between 2003 and 2012 for investigation of resistance mechanisms and/or outbreaks. MBL genes were detected by PCR. Typing was carried out by nine-locus variable-number tandem repeat (VNTR) analysis and MLST. MBL-producing P. aeruginosa isolates were referred from 267 source patients and 89 UK laboratories. The most common isolation sites were urine (24%), respiratory (18%), wounds (17%) and blood (13%). VIM-type MBLs predominated (91% of all MBLs found), but a few IMP- and NDM-type enzymes were also identified. Diverse VNTR types were seen, but 86% of isolates belonged to six major complexes. MLST of representative isolates from each complex showed that they corresponded to STs 111, 233, 235, 357, 654 and 773, respectively. Isolates belonging to these complexes were received from between 9 and 25 UK referring laboratories each. The incidence of MBL-producing P. aeruginosa is increasing in the UK. The majority of these isolates belong to several 'high-risk clones', which have been previously reported internationally as host clones of MBLs. © Crown copyright 2014.

Multicomponent blood lipid analysis by means of near infrared spectroscopy, in geese.

PubMed

Bazar, George; Eles, Viktoria; Kovacs, Zoltan; Romvari, Robert; Szabo, Andras

2016-08-01

This study provides accurate near infrared (NIR) spectroscopic models on some laboratory determined clinicochemical parameters (i.e. total lipid (5.57±1.95 g/l), triglyceride (2.59±1.36 mmol/l), total cholesterol (3.81±0.68 mmol/l), high density lipoprotein (HDL) cholesterol (2.45±0.58 mmol/l)) of blood serum samples of fattened geese. To increase the performance of multivariate chemometrics, samples significantly deviating from the regression models implying laboratory error were excluded from the final calibration datasets. Reference data of excluded samples having outlier spectra in principal component analysis were not marked as false. Samples deviating from the regression models but having non outlier spectra in PCA were identified as having false reference constituent values. Based on the NIR selection methods, 5% of the reference measurement data were rated as doubtful. The achieved models reached R(2) of 0.864, 0.966, 0.850, 0.793, and RMSE of 0.639 g/l, 0.232 mmol/l, 0.210 mmol/l, 0.241 mmol/l for total lipid, triglyceride, total cholesterol and HDL cholesterol, respectively, during independent validation. Classical analytical techniques focus on single constituents and often require chemicals, time-consuming measurements, and experienced technicians. NIR technique provides a quick, cost effective, non-hazardous alternative method for analysis of several constituents based on one single spectrum of each sample, and it also offers the possibility for looking at the laboratory reference data critically. Evaluation of reference data to identify and exclude falsely analyzed samples can provide warning feedback to the reference laboratory, especially in the case of analyses where laboratory methods are not perfectly suited to the subjected material and there is an increased chance of laboratory error. Copyright © 2016 Elsevier B.V. All rights reserved.

[Useful web sites for information about the recommendations of good practices in laboratory medicine].

PubMed

Szymanowicz, A; Watine, J

2010-12-01

In this paper are presented some useful web sites to find updated reference tables concerning the recommendations of professional practices in laboratory medicine. The knowledge of these reference tables can allow the biologist to develop its role of advice to the clinicians. It can also help him to assure a relevant interpretation of the laboratory results and to value the interest for the patient.

Continuous age- and sex-adjusted reference intervals of urinary markers for cerebral creatine deficiency syndromes: a novel approach to the definition of reference intervals.

PubMed

Mørkrid, Lars; Rowe, Alexander D; Elgstoen, Katja B P; Olesen, Jess H; Ruijter, George; Hall, Patricia L; Tortorelli, Silvia; Schulze, Andreas; Kyriakopoulou, Lianna; Wamelink, Mirjam M C; van de Kamp, Jiddeke M; Salomons, Gajja S; Rinaldo, Piero

2015-05-01

Urinary concentrations of creatine and guanidinoacetic acid divided by creatinine are informative markers for cerebral creatine deficiency syndromes (CDSs). The renal excretion of these substances varies substantially with age and sex, challenging the sensitivity and specificity of postanalytical interpretation. Results from 155 patients with CDS and 12 507 reference individuals were contributed by 5 diagnostic laboratories. They were binned into 104 adjacent age intervals and renormalized with Box-Cox transforms (Ξ). Estimates for central tendency (μ) and dispersion (σ) of Ξ were obtained for each bin. Polynomial regression analysis was used to establish the age dependence of both μ[log(age)] and σ[log(age)]. The regression residuals were then calculated as z-scores = {Ξ - μ[log(age)]}/σ[log(age)]. The process was iterated until all z-scores outside Tukey fences ±3.372 were identified and removed. Continuous percentile charts were then calculated and plotted by retransformation. Statistically significant and biologically relevant subgroups of z-scores were identified. Significantly higher marker values were seen in females than males, necessitating separate reference intervals in both adolescents and adults. Comparison between our reconstructed reference percentiles and current standard age-matched reference intervals highlights an underlying risk of false-positive and false-negative events at certain ages. Disease markers depending strongly on covariates such as age and sex require large numbers of reference individuals to establish peripheral percentiles with sufficient precision. This is feasible only through collaborative data sharing and the use of appropriate statistical methods. Broad application of this approach can be implemented through freely available Web-based software. © 2015 American Association for Clinical Chemistry.

Isotope reference materials

USGS Publications Warehouse

Coplen, Tyler B.

2010-01-01

Measurement of the same isotopically homogeneous sample by any laboratory worldwide should yield the same isotopic composition within analytical uncertainty. International distribution of light element isotopic reference materials by the International Atomic Energy Agency and the U.S. National Institute of Standards and Technology enable laboratories to achieve this goal.

Theory testing in prehistoric North America: fruits of one of the world's great archeological natural laboratories.

PubMed

Bingham, Paul M; Souza, Joanne

2013-01-01

This paper has several interconnected goals. First and most generally, we will review the project represented by the papers in this dedicated issue and the SAA Symposium (2012) on Social Complexity and the Bow. This project centers on the ever-stronger and broader theory testing now becoming feasible in archeology and anthropology, in this case exploiting the unique natural laboratory represented by what we refer to as the North American Neolithic transitions. Second, we will strive to synopsize the papers in this issue as opportunities to falsify two general theories of the cause of increases in social complexity associated with the North American Neolithic: warfare and social coercion theories.(1) We argue that, though much work remains to be done, the current evidence supports one of the central predictions of both these theories, that the local arrival of elite bow technology was a central driver of local transitions to increased social complexity. This conclusion, if ultimately verified, has profound implications for the possibility of general theories of history. Third, we will argue that several important details of this evidence falsify warfare theory and support (fail to falsify) social coercion theory (the authors' favored perspective). Moreover, several potential falsifications of social coercion theory are amenable to alternative interpretations, leading to new falsifiable predictions. Finally, we discuss how interactions with our colleagues in this project produced new insights into several details of the predictions of social coercion theory, improving our interpretative capacity. Copyright © 2013 Wiley Periodicals, Inc.

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

Results of an inter and intra laboratory exercise on the assessment of complex autosomal DNA profiles.

PubMed

Benschop, Corina C G; Connolly, Edward; Ansell, Ricky; Kokshoorn, Bas

2017-01-01

The interpretation of complex DNA profiles may differ between laboratories and reporting officers, which can lead to discrepancies in the final reports. In this study, we assessed the intra and inter laboratory variation in DNA mixture interpretation for three European ISO17025-accredited laboratories. To this aim, 26 reporting officers analyzed five sets of DNA profiles. Three main aspects were considered: 1) whether the mixed DNA profiles met the criteria for comparison to a reference profile, 2) the actual result of the comparison between references and DNA profiling data and 3) whether the weight of the DNA evidence could be assessed. Similarity in answers depended mostly on the complexity of the tasks. This study showed less variation within laboratories than between laboratories which could be the result of differences between internal laboratory guidelines and methods and tools available. Results show the profile types for which the three laboratories report differently, which informs indirectly on the complexity threshold the laboratories employ. Largest differences between laboratories were caused by the methods available to assess the weight of the DNA evidence. This exercise aids in training forensic scientists, refining laboratory guidelines and explaining differences between laboratories in court. Undertaking more collaborative exercises in future may stimulate dialog and consensus regarding interpretation. For training purposes, DNA profiles of the mixed stains and questioned references are made available. Copyright © 2016 The Chartered Society of Forensic Sciences. Published by Elsevier Ireland Ltd. All rights reserved.

CLSI-based transference and verification of CALIPER pediatric reference intervals for 29 Ortho VITROS 5600 chemistry assays.

PubMed

Higgins, Victoria; Truong, Dorothy; Woroch, Amy; Chan, Man Khun; Tahmasebi, Houman; Adeli, Khosrow

2018-03-01

Evidence-based reference intervals (RIs) are essential to accurately interpret pediatric laboratory test results. To fill gaps in pediatric RIs, the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) project developed an age- and sex-specific pediatric RI database based on healthy pediatric subjects. Originally established for Abbott ARCHITECT assays, CALIPER RIs were transferred to assays on Beckman, Roche, Siemens, and Ortho analytical platforms. This study provides transferred reference intervals for 29 biochemical assays for the Ortho VITROS 5600 Chemistry System (Ortho). Based on Clinical Laboratory Standards Institute (CLSI) guidelines, a method comparison analysis was performed by measuring approximately 200 patient serum samples using Abbott and Ortho assays. The equation of the line of best fit was calculated and the appropriateness of the linear model was assessed. This equation was used to transfer RIs from Abbott to Ortho assays. Transferred RIs were verified using 84 healthy pediatric serum samples from the CALIPER cohort. RIs for most chemistry analytes successfully transferred from Abbott to Ortho assays. Calcium and CO 2 did not meet statistical criteria for transference (r 2 <0.70). Of the 32 transferred reference intervals, 29 successfully verified with approximately 90% of results from reference samples falling within transferred confidence limits. Transferred RIs for total bilirubin, magnesium, and LDH did not meet verification criteria and are not reported. This study broadens the utility of the CALIPER pediatric RI database to laboratories using Ortho VITROS 5600 biochemical assays. Clinical laboratories should verify CALIPER reference intervals for their specific analytical platform and local population as recommended by CLSI. Copyright © 2018 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

46 CFR 164.013-2 - Incorporation by reference.

Code of Federal Regulations, 2014 CFR

2014-10-01

.... All approved material incorporated by reference may be inspected at the National Archives and Records... Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE., Washington...: Underwriters Laboratories (UL) Underwriters Laboratories, Inc., P.O. Box 13995, Research Triangle Park, NC...

46 CFR 164.013-2 - Incorporation by reference.

Code of Federal Regulations, 2013 CFR

2013-10-01

.... All approved material incorporated by reference may be inspected at the National Archives and Records... Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE., Washington...: Underwriters Laboratories (UL) Underwriters Laboratories, Inc., P.O. Box 13995, Research Triangle Park, NC...

Extensively Drug-Resistant Tuberculosis (XDR TB)

MedlinePlus

... TB Reference Laboratory Network, the National TB Surveillance System in the United States, the national reference laboratory of South Korea, and ... capacity in the U.S. and abroad; and Developing education, risk, and media communications ... – United States, 1993–2006 CDC. CDC’s Role in Preventing XDR ...

Storage and utilization of HLA genomic data--new approaches to HLA typing.

PubMed

Helmberg, W

2000-01-01

Currently available DNA-based HLA typing assays can provide detailed information about sequence motifs of a tested sample. It is still a common practice, however, for information acquired by high-resolution sequence specific oligonucleotide probe (SSOP) typing or sequence specific priming (SSP) to be presented in a low-resolution serological format. Unfortunately, this representation can lead to significant loss of useful data in many cases. An alternative to assigning allele equivalents to suchDNA typing results is simply to store the observed typing pattern and utilize the information with the help of Virtual DNA Analysis (VDA). Interpretation of the stored typing patterns can then be updated based on newly defined alleles, assuming the sequence motifs detected by the typing reagents are known. Rather than updating reagent specificities in individual laboratories, such updates should be performed in a central, publicly available sequence database. By referring to this database, HLA genomic data can then be stored and transferred between laboratories without loss of information. The 13th International Histocompatibility Workshop offers an ideal opportunity to begin building this common database for the entire human MHC.

Monte Carlo study of a 60Co calibration field of the Dosimetry Laboratory Seibersdorf.

PubMed

Hranitzky, C; Stadtmann, H

2007-01-01

The gamma radiation fields of the reference irradiation facility of the Dosimetry Laboratory Seibersdorf with collimated beam geometry are used for calibrating radiation protection dosemeters. A close-to-reality simulation model of the facility including the complex geometry of a 60Co source was set up using the Monte Carlo code MCNP. The goal of this study is to characterise the radionuclide gamma calibration field and resulting air-kerma distributions inside the measurement hall with a total of 20 m in length. For the whole range of source-detector-distances (SDD) along the central beam axis, simulated and measured relative air-kerma values are within +/-0.6%. Influences on the accuracy of the simulation results are investigated, including e.g., source mass density effects or detector volume dependencies. A constant scatter contribution from the lead ring-collimator of approximately 1% and an increasing scatter contribution from the concrete floor for distances above 7 m are identified, resulting in a total air-kerma scatter contribution below 5%, which is in accordance to the ISO 4037-1 recommendations.

Comparison of 133 xenon ventilation equilibrium scan (XV) and 99m technetium transmission (TT) scan for use in regional lung analysis by 2D gamma scintigraphy in healthy and cystic fibrosis lungs.

PubMed

Zeman, Kirby L; Wu, Jihong; Donaldson, Scott H; Bennett, William D

2013-04-01

Quantification of particle deposition in the lung by gamma scintigraphy requires a reference image for location of regions of interest (ROIs) and normalization to lung thickness. In various laboratories, the reference image is made by a transmission scan ((57)Co or (99m)Tc) or gas ventilation scan ((133)Xe or (81)Kr). There has not been a direct comparison of measures from the two methods. We compared (99m)Tc transmission scans to (133)Xe equilibrium ventilation scans as reference images for 38 healthy subjects and 14 cystic fibrosis (CF) patients for their effects on measures of regional particle deposition: the central-to-peripheral ratio of lung counts (C/P); and ROI area versus forced vital capacity. Whole right lung ROI was based on either an isocontour threshold of three times the soft tissue transmission (TT) or a threshold of 20% of peak xenon ventilation counts (XV). We used a central ROI drawn to 50% of height and of width of the whole right lung ROI and placed along the left lung margin and centered vertically. In general, the correlation of normalized C/P (nC/P) between the two methods was strong. However, the value of nC/P was significantly smaller for the XV method than the TT method. Regression equations for the relationship of nC/P between the two methods were, for healthy subjects, y=0.75x+0.61, R(2)=0.64 using rectangular ROIs and y=0.76x+0.45, R(2)=0.66 using isocontour ROIs; and for CF patients, y=0.94x+0.46, R(2)=0.43 and y=0.85x+0.42, R(2)=0.41, respectively. (1) A transmission scan with an isocontour outline in combination with a rectangular central region to define the lung borders may be more useful than a ventilation scan. (2) Close correlation of nC/Ps measured by transmission or gas ventilation should allow confident comparison of values determined by the two methods.

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.

[TDM management system for contribution to proper use of anti-mRSA drugs--establishment of cooperation support system between pharmacy and clinical laboratory in hospital].

PubMed

Yodoshi, Masahiro; Iwasaki, Naomi; Satoh, Kaori; Nomura, Morihiro; Morishima, Yoshiyuki; Nakae, Kenichi; Yamazoe, Yuzuru

2013-02-01

In team medicine, highly specialized pharmacists have recently been in demand. As one of the specialties, there is therapeutic drug monitoring (TDM). It is important for the optimal dosing of a wide range of drugs. In our hospital, a TDM service was started in 1987 at the clinical laboratory. A clinical laboratory technologist with the license of a pharmacist has performed administration plans for anti-methicillin-resistant Staphylococcus aureus (MRSA) drugs, vancomycin, teicoplanin, and arbekacin. In particular, the pharmacist in charge of TDM services, a TDM-specialized pharmacist, plays a central role in administration plans for anti MRSA drugs. Furthermore, we examined the active use of the TDM service to expand pharmaceutical care. Therefore, at first, we have worked in partnership with the clinical laboratory, as it is called the "Cooperation Support System", since September 2010. As a result, after the introduction of this system, from August 2011 to July 2012, the rate that the doctor referred to the administration plan was markedly improved by approximately 90%. We have been able to enhance TDM in practical training for pharmacology as an extension of this system. We thought that drug therapy can be performed more appropriately by increasing the number of executions of TDM in the future. For drug therapy to be done more appropriately, efforts made through cooperation with the clinical laboratory are essential for an effective TDM system. Naturally, an effective TDM process requires a collaborative, multidisciplinary approach with input from doctors, nurses, and clinical pharmacists.

External quality assessment for KRAS testing is needed: setup of a European program and report of the first joined regional quality assessment rounds.

PubMed

Bellon, Ellen; Ligtenberg, Marjolijn J L; Tejpar, Sabine; Cox, Karen; de Hertogh, Gert; de Stricker, Karin; Edsjö, Anders; Gorgoulis, Vassilis; Höfler, Gerald; Jung, Andreas; Kotsinas, Athanassios; Laurent-Puig, Pierre; López-Ríos, Fernando; Hansen, Tine Plato; Rouleau, Etienne; Vandenberghe, Peter; van Krieken, Johan J M; Dequeker, Elisabeth

2011-01-01

The use of epidermal growth factor receptor-targeting antibodies in metastatic colorectal cancer has been restricted to patients with wild-type KRAS tumors by the European Medicines Agency since 2008, based on data showing a lack of efficacy and potential harm in patients with mutant KRAS tumors. In an effort to ensure optimal, uniform, and reliable community-based KRAS testing throughout Europe, a KRAS external quality assessment (EQA) scheme was set up. The first large assessment round included 59 laboratories from eight different European countries. For each country, one regional scheme organizer prepared and distributed the samples for the participants of their own country. The samples included unstained sections of 10 invasive colorectal carcinomas with known KRAS mutation status. The samples were centrally validated by one of two reference laboratories. The laboratories were allowed to use their own preferred method for histological evaluation, DNA isolation, and mutation analysis. In this study, we analyze the setup of the KRAS scheme. We analyzed the advantages and disadvantages of the regional scheme organization by analyzing the outcome of genotyping results, analysis of tumor percentage, and written reports. We conclude that only 70% of laboratories correctly identified the KRAS mutational status in all samples. Both the false-positive and false-negative results observed negatively affect patient care. Reports of the KRAS test results often lacked essential information. We aim to further expand this program to more laboratories to provide a robust estimate of the quality of KRAS testing in Europe, and provide the basis for remedial measures and harmonization.

Iowa Central Quality Fuel Testing Laboratory

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

Heach, Don; Bidieman, Julaine

2013-09-30

The objective of this project is to finalize the creation of an independent quality fuel testing laboratory on the campus of Iowa Central Community College in Fort Dodge, Iowa that shall provide the exploding biofuels industry a timely and cost-effective centrally located laboratory to complete all state and federal fuel and related tests that are required. The recipient shall work with various state regulatory agencies, biofuel companies and state and national industry associations to ensure that training and testing needs of their members and American consumers are met. The recipient shall work with the Iowa Department of Ag and Landmore » Stewardship on the development of an Iowa Biofuel Quality Standard along with the Development of a standard that can be used throughout industry.« less

Laboratory and software applications for clinical trials: the global laboratory environment.

PubMed

Briscoe, Chad

2011-11-01

The Applied Pharmaceutical Software Meeting is held annually. It is sponsored by The Boston Society, a not-for-profit organization that coordinates a series of meetings within the global pharmaceutical industry. The meeting generally focuses on laboratory applications, but in recent years has expanded to include some software applications for clinical trials. The 2011 meeting emphasized the global laboratory environment. Global clinical trials generate massive amounts of data in many locations that must be centralized and processed for efficient analysis. Thus, the meeting had a strong focus on establishing networks and systems for dealing with the computer infrastructure to support such environments. In addition to the globally installed laboratory information management system, electronic laboratory notebook and other traditional laboratory applications, cloud computing is quickly becoming the answer to provide efficient, inexpensive options for managing the large volumes of data and computing power, and thus it served as a central theme for the meeting.

Assessment of central haemomodynamics from a brachial cuff in a community setting

PubMed Central

2012-01-01

Background Large artery stiffening and wave reflections are independent predictors of adverse events. To date, their assessment has been limited to specialised techniques and settings. A new, more practical method allowing assessment of central blood pressure from waveforms recorded using a conventional automated oscillometric monitor has recently been validated in laboratory settings. However, the feasibility of this method in a community based setting has not been assessed. Methods One-off peripheral and central haemodynamic (systolic and diastolic blood pressure (BP) and pulse pressure) and wave reflection parameters (augmentation pressure (AP) and index, AIx) were obtained from 1,903 volunteers in an Austrian community setting using a transfer-function like method (ARCSolver algorithm) and from waveforms recorded with a regular oscillometric cuff. We assessed these parameters for known differences and associations according to gender and age deciles from <30 years to >80 years in the whole population and a subset with a systolic BP < 140 mmHg. Results We obtained 1,793 measures of peripheral and central BP, PP and augmentation parameters. Age and gender associations with central haemodynamic and augmentation parameters reflected those previously established from reference standard non-invasive techniques under specialised settings. Findings were the same for patients with a systolic BP below 140 mmHg (i.e. normotensive). Lower values for AIx in the current study are possibly due to differences in sampling rates, detection frequency and/or averaging procedures and to lower numbers of volunteers in younger age groups. Conclusion A novel transfer-function like algorithm, using brachial cuff-based waveform recordings, provides robust and feasible estimates of central systolic pressure and augmentation in community-based settings. PMID:22734820

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.

[How many kids are there with excess weight? What information should be published?

PubMed

Pérez-Ríos, Mónica; Santiago-Pérez, María I; Malvar Pintos, Alberto; Suanzes Hernández, Jorge; Hervada Vidal, Xurxo

2018-06-11

In epidemiological studies, there is no consensus on which references should be used to characterize the weight status of schoolchildren after estimating their body mass index. The aim of this study is to evaluate the influence that different criteria have on the characterization of the weight status of Galician schoolchildren from 6 to 15 years old and to identify the criterion that best characterizes central obesity. Cross-sectional study on a sample of 7.438 schoolchildren representative by sex and age of the Galician population of 6 to 15 year olds. The prevalence of central obesity and underweight, normal weight, overweight and obesity was estimated using the reference standards of the World Health Organization (WHO), Cole, Orbegozo-2011 and the Enkid study. In order to identify the criterion that best characterizes central obesity, the positive predictive values of obesity and the negative ones of overweight and obesity were calculated. The characterization of schoolchildren according to their weight status was different depending on the reference used with estimates that vary by 20.4 percentage points being prevalence of excess weight using WHO references 41.5% while with Enkid it is 21.1%. The reference with the best predictive capacity of central obesity was those proposed by Cole. The variability observed in the characterization of the weight status of schoolchildren asso- ciated with the use of different reference criteria is very important. If central obesity is a good indicator of excess of weight, the reference proposed by Cole would be the one with the best capacity to characterize the child and youth population, related to the best predictive capacity.

[Investigation of reference intervals of blood gas and acid-base analysis assays in China].

PubMed

Zhang, Lu; Wang, Wei; Wang, Zhiguo

2015-10-01

To investigate and analyze the upper and lower limits and their sources of reference intervals in blood gas and acid-base analysis assays. The data of reference intervals were collected, which come from the first run of 2014 External Quality Assessment (EQA) program in blood gas and acid-base analysis assays performed by National Center for Clinical Laboratories (NCCL). All the abnormal values and errors were eliminated. Data statistics was performed by SPSS 13.0 and Excel 2007 referring to upper and lower limits of reference intervals and sources of 7 blood gas and acid-base analysis assays, i.e. pH value, partial pressure of carbon dioxide (PCO2), partial pressure of oxygen (PO2), Na+, K+, Ca2+ and Cl-. Values were further grouped based on instrument system and the difference between each group were analyzed. There were 225 laboratories submitting the information on the reference intervals they had been using. The three main sources of reference intervals were National Guide to Clinical Laboratory Procedures [37.07% (400/1 079)], instructions of instrument manufactures [31.23% (337/1 079)] and instructions of reagent manufactures [23.26% (251/1 079)]. Approximately 35.1% (79/225) of the laboratories had validated the reference intervals they used. The difference of upper and lower limits in most assays among 7 laboratories was moderate, both minimum and maximum (i.e. the upper limits of pH value was 7.00-7.45, the lower limits of Na+ was 130.00-156.00 mmol/L), and mean and median (i.e. the upper limits of K+ was 5.04 mmol/L and 5.10 mmol/L, the upper limits of PCO2 was 45.65 mmHg and 45.00 mmHg, 1 mmHg = 0.133 kPa), as well as the difference in P2.5 and P97.5 between each instrument system group. It was shown by Kruskal-Wallis method that the P values of upper and lower limits of all the parameters were lower than 0.001, expecting the lower limits of Na+ with P value 0.029. It was shown by Mann-Whitney that the statistic differences were found among instrument system groups and between most of two instrument system groups in all assays. The difference of reference intervals of blood gas and acid-base analysis assays used in China laboratories is moderate, which is better than other specialties in clinical laboratories.

Genetics Home Reference: central core disease

MedlinePlus

... Twitter Home Health Conditions Central core disease Central core disease Printable PDF Open All Close All Enable ... to view the expand/collapse boxes. Description Central core disease is a disorder that affects muscles used ...

Comparison of microbiological diagnosis of urinary tract infection in young children by routine health service laboratories and a research laboratory: Diagnostic cohort study

PubMed Central

Birnie, Kate; Hay, Alastair D.; Wootton, Mandy; Howe, Robin; MacGowan, Alasdair; Whiting, Penny; Lawton, Michael; Delaney, Brendan; Downing, Harriet; Dudley, Jan; Hollingworth, William; Lisles, Catherine; Little, Paul; O’Brien, Kathryn; Pickles, Timothy; Rumsby, Kate; Thomas-Jones, Emma; Van der Voort, Judith; Waldron, Cherry-Ann; Harman, Kim; Hood, Kerenza; Butler, Christopher C.; Sterne, Jonathan A. C.

2017-01-01

Objectives To compare the validity of diagnosis of urinary tract infection (UTI) through urine culture between samples processed in routine health service laboratories and those processed in a research laboratory. Population and methods We conducted a prospective diagnostic cohort study in 4808 acutely ill children aged <5 years attending UK primary health care. UTI, defined as pure/predominant growth ≥105 CFU/mL of a uropathogen (the reference standard), was diagnosed at routine health service laboratories and a central research laboratory by culture of urine samples. We calculated areas under the receiver-operator curve (AUC) for UTI predicted by pre-specified symptoms, signs and dipstick test results (the “index test”), separately according to whether samples were obtained by clean catch or nappy (diaper) pads. Results 251 (5.2%) and 88 (1.8%) children were classified as UTI positive by health service and research laboratories respectively. Agreement between laboratories was moderate (kappa = 0.36; 95% confidence interval [CI] 0.29, 0.43), and better for clean catch (0.54; 0.45, 0.63) than nappy pad samples (0.20; 0.12, 0.28). In clean catch samples, the AUC was lower for health service laboratories (AUC = 0.75; 95% CI 0.69, 0.80) than the research laboratory (0.86; 0.79, 0.92). Values of AUC were lower in nappy pad samples (0.65 [0.61, 0.70] and 0.79 [0.70, 0.88] for health service and research laboratory positivity, respectively) than clean catch samples. Conclusions The agreement of microbiological diagnosis of UTI comparing routine health service laboratories with a research laboratory was moderate for clean catch samples and poor for nappy pad samples and reliability is lower for nappy pad than for clean catch samples. Positive results from the research laboratory appear more likely to reflect real UTIs than those from routine health service laboratories, many of which (particularly from nappy pad samples) could be due to contamination. Health service laboratories should consider adopting procedures used in the research laboratory for paediatric urine samples. Primary care clinicians should try to obtain clean catch samples, even in very young children. PMID:28199403

46 CFR 164.013-2 - Incorporation by reference.

Code of Federal Regulations, 2012 CFR

2012-10-01

.... All approved material incorporated by reference may be inspected at the National Archives and Records Administration (NARA), and at the U.S. Coast Guard, Lifesaving and Fire Safety Division (CG-ENG-4), 2100 2nd St... as follows: Underwriters Laboratories (UL) Underwriters Laboratories, Inc., P.O. Box 13995, Research...

Japanese Society for Laboratory Hematology flow cytometric reference method of determining the differential leukocyte count: external quality assurance using fresh blood samples.

PubMed

Kawai, Y; Nagai, Y; Ogawa, E; Kondo, H

2017-04-01

To provide target values for the manufacturers' survey of the Japanese Society for Laboratory Hematology (JSLH), accurate standard data from healthy volunteers were needed for the five-part differential leukocyte count. To obtain such data, JSLH required an antibody panel that achieved high specificity (particularly for mononuclear cells) using simple gating procedures. We developed a flow cytometric method for determining the differential leukocyte count (JSLH-Diff) and validated it by comparison with the flow cytometric differential leukocyte count of the International Council for Standardization in Haematology (ICSH-Diff) and the manual differential count obtained by microscopy (Manual-Diff). First, the reference laboratory performed an imprecision study of JSLH-Diff and ICSH-Diff, as well as performing comparison among JSLH-Diff, Manual-Diff, and ICSH-Diff. Then two reference laboratories and seven participating laboratories performed imprecision and accuracy studies of JSLH-Diff, Manual-Diff, and ICSH-Diff. Simultaneously, six manufacturers' laboratories provided their own representative values by using automated hematology analyzers. The precision of both JSLH-Diff and ICSH-Diff methods was adequate. Comparison by the reference laboratory showed that all correlation coefficients, slopes and intercepts obtained by the JSLH-Diff, ICSH-Diff, and Manual-Diff methods conformed to the criteria. When the imprecision and accuracy of JSLH-Diff were assessed at seven laboratories, the CV% for lymphocytes, neutrophils, monocytes, eosinophils, and basophils was 0.5~0.9%, 0.3~0.7%, 1.7~2.6%, 3.0~7.9%, and 3.8~10.4%, respectively. More than 99% of CD45 positive leukocytes were identified as normal leukocytes by JSLH-Diff. When JSLH-Diff method were validated by comparison with Manual-Diff and ICSH-Diff, JSLH-Diff showed good performance as a reference method. © 2016 John Wiley & Sons Ltd.

Diffusion-controlled reference material for VOC emissions testing: proof of concept.

PubMed

Cox, S S; Liu, Z; Little, J C; Howard-Reed, C; Nabinger, S J; Persily, A

2010-10-01

Because of concerns about indoor air quality, there is growing awareness of the need to reduce the rate at which indoor materials and products emit volatile organic compounds (VOCs). To meet consumer demand for low emitting products, manufacturers are increasingly submitting materials to independent laboratories for emissions testing. However, the same product tested by different laboratories can result in very different emissions profiles because of a general lack of test validation procedures. There is a need for a reference material that can be used as a known emissions source and that will have the same emission rate when tested by different laboratories under the same conditions. A reference material was created by loading toluene into a polymethyl pentene film. A fundamental emissions model was used to predict the toluene emissions profile. Measured VOC emissions profiles using small-chamber emissions tests compared reasonably well to the emissions profile predicted using the emissions model, demonstrating the feasibility of the proposed approach to create a diffusion-controlled reference material. To calibrate emissions test chambers and improve the reproducibility of VOC emission measurements among different laboratories, a reference material has been created using a polymer film loaded with a representative VOC. Initial results show that the film's VOC emission profile measured in a conventional test chamber compares well to predictions based on independently determined material/chemical properties and a fundamental emissions model. The use of such reference materials has the potential to build consensus and confidence in emissions testing as well as 'level the playing field' for product testing laboratories and manufacturers.

The Then and Now of Reference Conditions in Streams of the Central Plains

NASA Astrophysics Data System (ADS)

Huggins, D.; Angelo, R.; Baker, D. S.; Welker, G.

2005-05-01

Models of contemporary and pre-settlement reference conditions were constructed for streams that once drained the tallgrass prairies of Iowa, Nebraska, Kansas and Missouri (e.g. Western Corn Belt Plains ecoregion), and for streams within the heart of the mixed grass prairie (e.g. Southwestern Tablelands ecoregion). Data on watershed, habitat, chemistry and biology compiled for existing reference streams (least or minimally impacted systems) were used to characterize contemporary reference conditions. Contemporary reference conditions within these two prairie regions are contrasted against hypothetical pre-settlement conditions using information from the best streams (upper 25%) of the current reference population, historical accounts, museum records, natural heritage programs, Public Land Survey and current remote sensing data. Similar comparisons were made between historical and current reference conditions for the Southwestern Tablelands located in central Kansas and Oklahoma. Much of this region remains in mixed grass prairie; has limited hydrological alterations (e.g. impoundments, dewatering) and low human and livestock densities. Within the tablelands these factors have preserved reference conditions that resemble historic conditions. Qualitative and quantitative comparisons indicate that many regions within the Central Plains require caution when using "least disturbed" reference streams and conditions to identify regional biological integrity goals relative to the Clean Water Act.

A survey of coagulation laboratory practices and satisfaction ratings of member laboratories of the Thailand National External Quality Assessment Scheme for blood coagulation.

PubMed

Chuntarut, A; Tientadakul, P; Wongkrajang, P

2016-06-01

The Thailand National External Quality Assessment Scheme (NEQAS) for blood coagulation was established in 2005. The objective of this study was to collect data of coagulation laboratory practices and satisfaction of NEQAS member. Two hundred seventy-six questionnaires were sent to laboratories that are members of NEQAS to obtain data relating to coagulation laboratory practice and satisfaction in 2014. Data from this survey were compared with data from the survey conducted in 2005 to evaluate levels of improvement. Of 276 questionnaires sent, 212 (76.8%) were returned. Improvements were characterized by the number of laboratories that (i) decreased use of 3.8% sodium citrate as anticoagulant; (ii) implemented use of at least two control levels for internal quality control; and (iii) implemented reporting of reference values with results, as well as establishing their own reference range and using geometric mean as the denominator for international normalized ratio calculation. For overall satisfaction, 179 of 206 (86.9%) participant laboratories reported being satisfied or very satisfied. Improvements in coagulation laboratory practices in Thailand were observed in every step of the total testing process. However, additional improvements are still needed, such as determination and use of a local reference range. © 2016 John Wiley & Sons Ltd.

[The National Reference Centres and Reference Laboratories. Importance and tasks].

PubMed

Laude, G; Ammon, A

2005-09-01

Since 1995, the German Federal Ministry for Health and Social Security funds National Reference Centres (NRC) for the laboratory surveillance of important pathogens and syndromes. Which pathogens or syndromes are selected to be covered by a NRC depends on their epidemiological relevance, the special diagnostic tools, problems with antimicrobial resistance and necessary infection control measures. Currently, there are 15 NRC, which are appointed for a period of 3 years (currently from January 2005 through December 2007). Towards the end of their appointment all NRC are evaluated by a group of specialists. The assessment of their achievements is guided by a catalogue of tasks for the NRC. In addition to the NRC, a total of 50 laboratories are appointed which provide specialist expertise for additional pathogens in order to have a broad range of pathogens for which specialist laboratories are available. Their predominant task is to give advice and support for special diagnostic problems. Both NRC and the specialist laboratories are important parts of the network for infectious disease epidemiology.

Laboratory Activities in Israel

ERIC Educational Resources Information Center

Mamlok-Naaman, Rachel; Barnea, Nitza

2012-01-01

Laboratory activities have long had a distinctive and central role in the science curriculum, and science educators have suggested that many benefits accrue from engaging students in science laboratory activities. Many research studies have been conducted to investigate the educational effectiveness of laboratory work in science education in…

Laboratory twinning to build capacity for rabies diagnosis.

PubMed

Fooks, Anthony R; Drew, Trevor W; Tu, Changchun

2016-03-05

In 2009, the UK's OIE Reference Laboratory for rabies, based at the APHA in Weybridge, was awarded a project to twin with the Changchun Veterinary Research Institute in the People's Republic of China to help the institute develop the skills and methods necessary to become an OIE Reference Laboratory itself. Here, Tony Fooks, Trevor Drew and Changchun Tu describe the OIE's twinning project and the success that has since been realised in China. British Veterinary Association.

The Kjeldahl method as a primary reference procedure for total protein in certified reference materials used in clinical chemistry. II. Selection of direct Kjeldahl analysis and its preliminary performance parameters.

PubMed

Vinklárková, Bára; Chromý, Vratislav; Šprongl, Luděk; Bittová, Miroslava; Rikanová, Milena; Ohnútková, Ivana; Žaludová, Lenka

2015-01-01

To select a Kjeldahl procedure suitable for the determination of total protein in reference materials used in laboratory medicine, we reviewed in our previous article Kjeldahl methods adopted by clinical chemistry and found an indirect two-step analysis by total Kjeldahl nitrogen corrected for its nonprotein nitrogen and a direct analysis made on isolated protein precipitates. In this article, we compare both procedures on various reference materials. An indirect Kjeldahl method gave falsely lower results than a direct analysis. Preliminary performance parameters qualify the direct Kjeldahl analysis as a suitable primary reference procedure for the certification of total protein in reference laboratories.

Orbitally shaken shallow fluid layers. II. An improved wall shear stress model

NASA Astrophysics Data System (ADS)

Alpresa, Paola; Sherwin, Spencer; Weinberg, Peter; van Reeuwijk, Maarten

2018-03-01

A new model for the analytical prediction of wall shear stress distributions at the base of orbitally shaken shallow fluid layers is developed. This model is a generalisation of the classical extended Stokes solution and will be referred to as the potential theory-Stokes model. The model is validated using a large set of numerical simulations covering a wide range of flow regimes representative of those used in laboratory experiments. It is demonstrated that the model is in much better agreement with the simulation data than the classical Stokes solution, improving the prediction in 63% of the studied cases. The central assumption of the model—which is to link the wall shear stress with the surface velocity—is shown to hold remarkably well over all regimes covered.

Library and Information Networks: Centralization and Decentralization.

ERIC Educational Resources Information Center

Segal, JoAnn S.

1988-01-01

Describes the development of centralized library networks and the current factors that make library sharing on a smaller scale feasible. The discussion covers the need to decide the level at which library cooperation should occur and the possibility of linking via the Open System Interface Reference Model. (37 references) (CLB)

Physics Laboratory Investigation of Vocational High School Field Stone and Concrete Construction Techniques in the Central Java Province (Indonesia)

ERIC Educational Resources Information Center

Purwandari, Ristiana Dyah

2015-01-01

The investigation aims in this study were to uncover the observations of infrastructures and physics laboratory in vocational high school for Stone and Concrete Construction Techniques Expertise Field or Teknik Konstruksi Batu dan Beton (TKBB)'s in Purwokerto Central Java Province, mapping the Vocational High School or Sekolah Menengah Kejuruan…

EPA LABORATORIES IMPLEMENT EMS PROGRAM

EPA Science Inventory

This paper highlights the breadth and magnitude of carrying out an effective Environmental Management System (EMS) program at the U.S. EPA's research and development laboratories. Federal research laboratories have unique operating challenges compared to more centralized industr...

Clinical Variant Classification: A Comparison of Public Databases and a Commercial Testing Laboratory.

PubMed

Gradishar, William; Johnson, KariAnne; Brown, Krystal; Mundt, Erin; Manley, Susan

2017-07-01

There is a growing move to consult public databases following receipt of a genetic test result from a clinical laboratory; however, the well-documented limitations of these databases call into question how often clinicians will encounter discordant variant classifications that may introduce uncertainty into patient management. Here, we evaluate discordance in BRCA1 and BRCA2 variant classifications between a single commercial testing laboratory and a public database commonly consulted in clinical practice. BRCA1 and BRCA2 variant classifications were obtained from ClinVar and compared with the classifications from a reference laboratory. Full concordance and discordance were determined for variants whose ClinVar entries were of the same pathogenicity (pathogenic, benign, or uncertain). Variants with conflicting ClinVar classifications were considered partially concordant if ≥1 of the listed classifications agreed with the reference laboratory classification. Four thousand two hundred and fifty unique BRCA1 and BRCA2 variants were available for analysis. Overall, 73.2% of classifications were fully concordant and 12.3% were partially concordant. The remaining 14.5% of variants had discordant classifications, most of which had a definitive classification (pathogenic or benign) from the reference laboratory compared with an uncertain classification in ClinVar (14.0%). Here, we show that discrepant classifications between a public database and single reference laboratory potentially account for 26.7% of variants in BRCA1 and BRCA2 . The time and expertise required of clinicians to research these discordant classifications call into question the practicality of checking all test results against a database and suggest that discordant classifications should be interpreted with these limitations in mind. With the increasing use of clinical genetic testing for hereditary cancer risk, accurate variant classification is vital to ensuring appropriate medical management. There is a growing move to consult public databases following receipt of a genetic test result from a clinical laboratory; however, we show that up to 26.7% of variants in BRCA1 and BRCA2 have discordant classifications between ClinVar and a reference laboratory. The findings presented in this paper serve as a note of caution regarding the utility of database consultation. © AlphaMed Press 2017.

Effluent-Monitoring Procedures: Basic Laboratory Skills. Student Reference Manual.

ERIC Educational Resources Information Center

Engel, William T.; And Others

This is one of several short-term courses developed to assist in the training of waste water treatment plant operational personnel in the tests, measurements, and report preparation required for compliance with their NPDES Permits. This Student Reference Manual provides a review of basic mathematics as it applies to the chemical laboratory. The…

Bacterial and fungal components in house dust of farm children, Rudolf Steiner school children and reference children--the PARSIFAL Study.

PubMed

Schram, D; Doekes, G; Boeve, M; Douwes, J; Riedler, J; Ublagger, E; von Mutius, E; Budde, J; Pershagen, G; Nyberg, F; Alm, J; Braun-Fahrländer, C; Waser, M; Brunekreef, B

2005-05-01

Growing up on a farm and an anthroposophic lifestyle are associated with a lower prevalence of allergic diseases in childhood. It has been suggested that the enhanced exposure to endotoxin is an important protective factor of farm environments. Little is known about exposure to other microbial components on farms and exposure in anthroposophic families. To assess the levels and determinants of bacterial endotoxin, mould beta(1,3)-glucans and fungal extracellular polysaccharides (EPS) in house dust of farm children, Steiner school children and reference children. Mattress and living room dust was collected in the homes of 229 farm children, 122 Steiner children and 60 and 67 of their respective reference children in five European countries. Stable dust was collected as well. All samples were analysed in one central laboratory. Determinants were assessed by questionnaire. Levels of endotoxin, EPS and glucans per gram of house dust in farm homes were 1.2- to 3.2-fold higher than levels in reference homes. For Steiner children, 1.1- to 1.6-fold higher levels were observed compared with their reference children. These differences were consistently found across countries, although mean levels varied considerably. Differences between groups and between countries were also significant after adjustment for home and family characteristics. Farm children are not only consistently exposed to higher levels of endotoxin, but also to higher levels of mould components. Steiner school children may also be exposed to higher levels of microbial agents, but differences with reference children are much less pronounced than for farm children. Further analyses are, however, required to assess the association between exposure to these various microbial agents and allergic and airway diseases in the PARSIFAL population.

GCR Simulator Reference Field and a Spectral Approach for Laboratory Simulation

NASA Technical Reports Server (NTRS)

Slaba, Tony C.; Blattnig, Steve R.; Norbury, John W.; Rusek, Adam; La Tessa, Chiara; Walker, Steven A.

2015-01-01

The galactic cosmic ray (GCR) simulator at the NASA Space Radiation Laboratory (NSRL) is intended to deliver the broad spectrum of particles and energies encountered in deep space to biological targets in a controlled laboratory setting. In this work, certain aspects of simulating the GCR environment in the laboratory are discussed. Reference field specification and beam selection strategies at NSRL are the main focus, but the analysis presented herein may be modified for other facilities. First, comparisons are made between direct simulation of the external, free space GCR field and simulation of the induced tissue field behind shielding. It is found that upper energy constraints at NSRL limit the ability to simulate the external, free space field directly (i.e. shielding placed in the beam line in front of a biological target and exposed to a free space spectrum). Second, variation in the induced tissue field associated with shielding configuration and solar activity is addressed. It is found that the observed variation is likely within the uncertainty associated with representing any GCR reference field with discrete ion beams in the laboratory, given current facility constraints. A single reference field for deep space missions is subsequently identified. Third, an approach for selecting beams at NSRL to simulate the designated reference field is presented. Drawbacks of the proposed methodology are discussed and weighed against alternative simulation strategies. The neutron component and track structure characteristics of the simulated field are discussed in this context.

Standardization of gamma-glutamyltransferase assays by intermethod calibration. Effect on determining common reference limits.

PubMed

Steinmetz, Josiane; Schiele, Françoise; Gueguen, René; Férard, Georges; Henny, Joseph

2007-01-01

The improvement of the consistency of gamma-glutamyltransferase (GGT) activity results among different assays after calibration with a common material was estimated. We evaluated if this harmonization could lead to reference limits common to different routine methods. Seven laboratories measured GGT activity using their own routine analytical system both according to the manufacturer's recommendation and after calibration with a multi-enzyme calibrator [value assigned by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) reference procedure]. All samples were re-measured using the IFCC reference procedure. Two groups of subjects were selected in each laboratory: a group of healthy men aged 18-25 years without long-term medication and with alcohol consumption less than 44 g/day and a group of subjects with elevated GGT activity. The day-to-day coefficients of variation were less than 2.9% in each laboratory. The means obtained in the group of healthy subjects without common calibration (range of the means 16-23 U/L) were significantly different from those obtained by the IFCC procedure in five laboratories. After calibration, the means remained significantly different from the IFCC procedure results in only one laboratory. For three calibrated methods, the slope values of linear regression vs. the IFCC procedure were not different from the value 1. The results obtained with these three methods for healthy subjects (n=117) were gathered and reference limits were calculated. These were 11-49 U/L (2.5th-97.5th percentiles). The calibration also improved the consistency of elevated results when compared to the IFCC procedure. The common calibration improved the level of consistency between different routine methods. It permitted to define common reference limits which are quite similar to those proposed by the IFCC. This approach should lead to a real benefit in terms of prevention, screening, diagnosis, therapeutic monitoring and for epidemiological studies.

[The "Instituto de Salud Carlos III" and the public health in Spain. Origin of laboratory medicine and of the central laboratories and research in public health].

PubMed

Nájera Morrondo, Rafael

2006-01-01

The "Instituto de Salud Carlos III" is the Central Public Health Laboratory in Spain with an important component of scientific research in health related areas, such as cancer, cardiovascular diseases, infectious diseases and environmental health. The article describes the development of the Public Health Institutes. arising from the introduction and development of scientific and laboratory based medicine and the introduction of vaccination and sanitation with the control of water and food. At about the same time, the discoveries in microbiology and immunology were produced, being the research activities incardinated with the practical advances in the control of products. To cope with the practical needs, Institutions were created with the responsibility of providing smallpox vaccine but incorporating very soon production of sera and other vaccines and water and sanitation control and foods control. At the same time. colonization of countries specially in Africa, South East Asia and explorations in Central America confront the Europeans with new diseases and the need of laboratories where to study them. These circumstances gave rise to the birth of the Central Public Health Laboratories and the National institutes of Health at the beginning of the XX century in many countries. In Spain, the Spanish Civil War was a breaking point in the development of such an institution that finally was reinvented with the creation of the Instituto de Salud Carlos III, in 1986, incorporating research and epidemiological surveillance and control of diseases and also the responsibilities of the Food and Drug Control, lately separated from it.

Optical Fiber Power Meter Comparison Between NIST and NIM.

PubMed

Vayshenker, I; Livigni, D J; Li, X; Lehman, J H; Li, J; Xiong, L M; Zhang, Z X

2010-01-01

We describe the results of a comparison of reference standards between the National Institute of Standards and Technology (NIST-USA) and National Institute of Metrology (NIM-China). We report optical fiber-based power measurements at nominal wavelengths of 1310 nm and 1550 nm. We compare the laboratories' reference standards by means of a commercial optical power meter. Measurement results showed the largest difference of less than 2.6 parts in 10(3), which is within the combined standard (k = 1) uncertainty for the laboratories' reference standards.

Preanalytic process linked to spuriously elevated HIV viral loads: improvement on an FDA-approved process.

PubMed

Procop, Gary W; Taege, Alan J; Starkey, Colleen; Tungsiripat, Marisa; Warner, Diane; Schold, Jesse D; Yen-Lieberman, Belinda

2017-09-01

The processing of specimens often occurs in a central processing area within laboratories. We demonstrated that plasma centrifuged in the central laboratory but allowed to remain within the primary tube following centrifugation was associated with spuriously elevated HIV viral loads compared with recentrifugation of the plasma just prior to testing. Copyright © 2016 Elsevier Inc. All rights reserved.

Use of diagnostic accuracy as a metric for evaluating laboratory proficiency with microarray assays using mixed-tissue RNA reference samples.

PubMed

Pine, P S; Boedigheimer, M; Rosenzweig, B A; Turpaz, Y; He, Y D; Delenstarr, G; Ganter, B; Jarnagin, K; Jones, W D; Reid, L H; Thompson, K L

2008-11-01

Effective use of microarray technology in clinical and regulatory settings is contingent on the adoption of standard methods for assessing performance. The MicroArray Quality Control project evaluated the repeatability and comparability of microarray data on the major commercial platforms and laid the groundwork for the application of microarray technology to regulatory assessments. However, methods for assessing performance that are commonly applied to diagnostic assays used in laboratory medicine remain to be developed for microarray assays. A reference system for microarray performance evaluation and process improvement was developed that includes reference samples, metrics and reference datasets. The reference material is composed of two mixes of four different rat tissue RNAs that allow defined target ratios to be assayed using a set of tissue-selective analytes that are distributed along the dynamic range of measurement. The diagnostic accuracy of detected changes in expression ratios, measured as the area under the curve from receiver operating characteristic plots, provides a single commutable value for comparing assay specificity and sensitivity. The utility of this system for assessing overall performance was evaluated for relevant applications like multi-laboratory proficiency testing programs and single-laboratory process drift monitoring. The diagnostic accuracy of detection of a 1.5-fold change in signal level was found to be a sensitive metric for comparing overall performance. This test approaches the technical limit for reliable discrimination of differences between two samples using this technology. We describe a reference system that provides a mechanism for internal and external assessment of laboratory proficiency with microarray technology and is translatable to performance assessments on other whole-genome expression arrays used for basic and clinical research.

Evaluation of locally established reference intervals for hematology and biochemistry parameters in Western Kenya.

PubMed

Odhiambo, Collins; Oyaro, Boaz; Odipo, Richard; Otieno, Fredrick; Alemnji, George; Williamson, John; Zeh, Clement

2015-01-01

Important differences have been demonstrated in laboratory parameters from healthy persons in different geographical regions and populations, mostly driven by a combination of genetic, demographic, nutritional, and environmental factors. Despite this, European and North American derived laboratory reference intervals are used in African countries for patient management, clinical trial eligibility, and toxicity determination; which can result in misclassification of healthy persons as having laboratory abnormalities. An observational prospective cohort study known as the Kisumu Incidence Cohort Study (KICoS) was conducted to estimate the incidence of HIV seroconversion and identify determinants of successful recruitment and retention in preparation for an HIV vaccine/prevention trial among young adults and adolescents in western Kenya. Laboratory values generated from the KICoS were compared to published region-specific reference intervals and the 2004 NIH DAIDS toxicity tables used for the trial. About 1106 participants were screened for the KICoS between January 2007 and June 2010. Nine hundred and fifty-three participants aged 16 to 34 years, HIV-seronegative, clinically healthy, and non-pregnant were selected for this analysis. Median and 95% reference intervals were calculated for hematological and biochemistry parameters. When compared with both published region-specific reference values and the 2004 NIH DAIDS toxicity table, it was shown that the use of locally established reference intervals would have resulted in fewer participants classified as having abnormal hematological or biochemistry values compared to US derived reference intervals from DAIDS (10% classified as abnormal by local parameters vs. >40% by US DAIDS). Blood urea nitrogen was most often out of range if US based intervals were used: <10% abnormal by local intervals compared to >83% by US based reference intervals. Differences in reference intervals for hematological and biochemical parameters between western and African populations highlight importance of developing local reference intervals for clinical care and trials in Africa.

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

PubMed

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

2007-01-01

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

Analysis of Thiodiglycol: Validation of Semi-Volatile Analysis by HPLC-MS/MS by EPA Method MS777

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

Owens, J; Koester, C

The Environmental Protection Agency's (EPA) Region 5 Chicago Regional Laboratory (CRL) developed a method for the analysis of thiodiglycol, the breakdown product of the sulfur mustard HD, in water by high performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS), titled Method EPA MS777 (hereafter referred to as EPA CRL SOP MS777). This draft standard operating procedure (SOP) was distributed to multiple EPA laboratories and to Lawrence Livermore National Laboratory, which was tasked to serve as a reference laboratory for EPA's Environmental Reference Laboratory Network (ERLN) and to develop and validate analytical procedures. The primary objective of this study was to verifymore » the analytical procedures described in MS777 for analysis of thiodiglycol in aqueous samples. The gathered data from this study will be used to: (1) demonstrate analytical method performance; (2) generate quality control acceptance criteria; and (3) revise the SOP to provide a validated method that would be available for use during a homeland security event. The data contained in this report will be compiled, by EPA CRL, with data generated by other EPA Regional laboratories so that performance metrics of Method EPA MS777 can be determined.« less

Simulation of large scale motions and small scale structures in planetary atmospheres and oceans: From laboratory to space experiments on ISS

NASA Astrophysics Data System (ADS)

Egbers, Christoph; Futterer, Birgit; Zaussinger, Florian; Harlander, Uwe

2014-05-01

Baroclinic waves are responsible for the transport of heat and momentum in the oceans, in the Earth's atmosphere as well as in other planetary atmospheres. The talk will give an overview on possibilities to simulate such large scale as well as co-existing small scale structures with the help of well defined laboratory experiments like the baroclinic wave tank (annulus experiment). The analogy between the Earth's atmosphere and the rotating cylindrical annulus experiment only driven by rotation and differential heating between polar and equatorial regions is obvious. From the Gulf stream single vortices seperate from time to time. The same dynamics and the co-existence of small and large scale structures and their separation can be also observed in laboratory experiments as in the rotating cylindrical annulus experiment. This experiment represents the mid latitude dynamics quite well and is part as a central reference experiment in the German-wide DFG priority research programme ("METSTRÖM", SPP 1276) yielding as a benchmark for lot of different numerical methods. On the other hand, those laboratory experiments in cylindrical geometry are limited due to the fact, that the surface and real interaction between polar and equatorial region and their different dynamics can not be really studied. Therefore, I demonstrate how to use the very successful Geoflow I and Geoflow II space experiment hardware on ISS with future modifications for simulations of small and large scale planetary atmospheric motion in spherical geometry with differential heating between inner and outer spheres as well as between the polar and equatorial regions. References: Harlander, U., Wenzel, J., Wang, Y., Alexandrov, K. & Egbers, Ch., 2012, Simultaneous PIV- and thermography measurements of partially blocked flow in a heated rotating annulus, Exp. in Fluids, 52 (4), 1077-1087 Futterer, B., Krebs, A., Plesa, A.-C., Zaussinger, F., Hollerbach, R., Breuer, D. & Egbers, Ch., 2013, Sheet-like and plume-like thermal flow in a spherical convection experiment performed under microgravity, J. Fluid Mech., vol. 75, p 647-683

NASA's DC-8 flying laboratory seen at sunset after a flight supporting the AirSAR 2004 Mesoamerica campaign

NASA Image and Video Library

2004-03-06

NASA's DC-8 flying laboratory seen at sunset after a flight supporting the AirSAR 2004 Mesoamerica campaign. AirSAR 2004 Mesoamerica is a three-week expedition by an international team of scientists that uses an all-weather imaging tool, called the Airborne Synthetic Aperture Radar (AirSAR) which is located onboard NASA's DC-8 airborne laboratory. Scientists from many parts of the world including NASA's Jet Propulsion Laboratory are combining ground research done in several areas in Central America with NASA's AirSAR technology to improve and expand on the quality of research they are able to conduct. The radar, developed by NASA's Jet Propulsion Laboratory, can penetrate clouds and also collect data at night. Its high-resolution sensors operate at multiple wavelengths and modes, allowing AirSAR to see beneath treetops, through thin sand, and dry snow pack. AirSAR's 2004 campaign is a collaboration of many U.S. and Central American institutions and scientists, including NASA; the National Science Foundation; the Smithsonian Institution; National Geographic; Conservation International; the Organization of Tropical Studies; the Central American Commission for Environment and Development; and the Inter-American Development Bank.

Automating the Analytical Laboratories Section, Lewis Research Center, National Aeronautics and Space Administration: A feasibility study

NASA Technical Reports Server (NTRS)

Boyle, W. G.; Barton, G. W.

1979-01-01

The feasibility of computerized automation of the Analytical Laboratories Section at NASA's Lewis Research Center was considered. Since that laboratory's duties are not routine, the automation goals were set with that in mind. Four instruments were selected as the most likely automation candidates: an atomic absorption spectrophotometer, an emission spectrometer, an X-ray fluorescence spectrometer, and an X-ray diffraction unit. Two options for computer automation were described: a time-shared central computer and a system with microcomputers for each instrument connected to a central computer. A third option, presented for future planning, expands the microcomputer version. Costs and benefits for each option were considered. It was concluded that the microcomputer version best fits the goals and duties of the laboratory and that such an automted system is needed to meet the laboratory's future requirements.

Etiologic Agents of Central Nervous System Infections among Febrile Hospitalized Patients in the Country of Georgia

PubMed Central

Akhvlediani, Tamar; Bautista, Christian T.; Shakarishvili, Roman; Tsertsvadze, Tengiz; Imnadze, Paata; Tatishvili, Nana; Davitashvili, Tamar; Samkharadze, Tamar; Chlikadze, Rusudan; Dvali, Natia; Dzigua, Lela; Karchava, Mariam; Gatserelia, Lana; Macharashvili, Nino; Kvirkvelia, Nana; Habashy, Engy Emil; Farrell, Margaret; Rowlinson, Emily; Sejvar, James; Hepburn, Matthew; Pimentel, Guillermo; Dueger, Erica; House, Brent; Rivard, Robert

2014-01-01

Objectives There is a large spectrum of viral, bacterial, fungal, and prion pathogens that cause central nervous system (CNS) infections. As such, identification of the etiological agent requires multiple laboratory tests and accurate diagnosis requires clinical and epidemiological information. This hospital-based study aimed to determine the main causes of acute meningitis and encephalitis and enhance laboratory capacity for CNS infection diagnosis. Methods Children and adults patients clinically diagnosed with meningitis or encephalitis were enrolled at four reference health centers. Cerebrospinal fluid (CSF) was collected for bacterial culture, and in-house and multiplex RT-PCR testing was conducted for herpes simplex virus (HSV) types 1 and 2, mumps virus, enterovirus, varicella zoster virus (VZV), Streptococcus pneumoniae, HiB and Neisseria meningitidis. Results Out of 140 enrolled patients, the mean age was 23.9 years, and 58% were children. Bacterial or viral etiologies were determined in 51% of patients. Five Streptococcus pneumoniae cultures were isolated from CSF. Based on in-house PCR analysis, 25 patients were positive for S. pneumoniae, 6 for N. meningitidis, and 1 for H. influenzae. Viral multiplex PCR identified infections with enterovirus (n = 26), VZV (n = 4), and HSV-1 (n = 2). No patient was positive for mumps or HSV-2. Conclusions Study findings indicate that S. pneumoniae and enteroviruses are the main etiologies in this patient cohort. The utility of molecular diagnostics for pathogen identification combined with the knowledge provided by the investigation may improve health outcomes of CNS infection cases in Georgia. PMID:25369023

Predictive value and efficiency of laboratory testing.

PubMed

Galen, R S

1980-11-01

Literature on determining reference values and reference intervals on "normal" or "healthy" individuals is abundant. It is impossible, however, to evaluate a data set of reference values and select a suitable reference interval that will be meaningful for the practice of medicine. The reference interval, no matter how derived statistically, tells us nothing about disease. This is the main reason the concepts of "normal values" have failed us and why "reference values" will prove similarly disappointing. By studying these same constituents in a variety of disease states as well, it will be possible to select "referent values" that will make the test procedure meaningful for diagnostic purposes. In order to obtain meaningful referent values for predicting disease, it is necessary to study not only the "healthy" reference population, but patients with the disease in question, and patients who are free of the disease in question but who have other diseases. Studies of this type are not frequently found for laboratory tests that are in common use today.

External Quality Assessment for KRAS Testing Is Needed: Setup of a European Program and Report of the First Joined Regional Quality Assessment Rounds

PubMed Central

Bellon, Ellen; Ligtenberg, Marjolijn J.L.; Tejpar, Sabine; Cox, Karen; de Hertogh, Gert; de Stricker, Karin; Edsjö, Anders; Gorgoulis, Vassilis; Höfler, Gerald; Jung, Andreas; Kotsinas, Athanassios; Laurent-Puig, Pierre; López-Ríos, Fernando; Hansen, Tine Plato; Rouleau, Etienne; Vandenberghe, Peter; van Krieken, Johan J.M.

2011-01-01

The use of epidermal growth factor receptor–targeting antibodies in metastatic colorectal cancer has been restricted to patients with wild-type KRAS tumors by the European Medicines Agency since 2008, based on data showing a lack of efficacy and potential harm in patients with mutant KRAS tumors. In an effort to ensure optimal, uniform, and reliable community-based KRAS testing throughout Europe, a KRAS external quality assessment (EQA) scheme was set up. The first large assessment round included 59 laboratories from eight different European countries. For each country, one regional scheme organizer prepared and distributed the samples for the participants of their own country. The samples included unstained sections of 10 invasive colorectal carcinomas with known KRAS mutation status. The samples were centrally validated by one of two reference laboratories. The laboratories were allowed to use their own preferred method for histological evaluation, DNA isolation, and mutation analysis. In this study, we analyze the setup of the KRAS scheme. We analyzed the advantages and disadvantages of the regional scheme organization by analyzing the outcome of genotyping results, analysis of tumor percentage, and written reports. We conclude that only 70% of laboratories correctly identified the KRAS mutational status in all samples. Both the false-positive and false-negative results observed negatively affect patient care. Reports of the KRAS test results often lacked essential information. We aim to further expand this program to more laboratories to provide a robust estimate of the quality of KRAS testing in Europe, and provide the basis for remedial measures and harmonization. PMID:21441573

Semantics, Cross-Cultural Style

ERIC Educational Resources Information Center

Machery, Edouard; Mallon, Ron; Nichols, Shaun; Stich, Stephen P.

2004-01-01

Theories of reference have been central to analytic philosophy, and two views, "the descriptivist view of reference" and "the causal-historical view of reference," have dominated the field. In this research tradition, theories of reference are assessed by consulting one's intuitions about the reference of terms in hypothetical situations. However,…

Evaluation of OMNIgene®•SPUTUM-stabilised sputum for long-term transport and Xpert® MTB/RIF testing in Nepal.

PubMed

Maharjan, B; Kelly-Cirino, C D; Weirich, A; Curry, P S; Hoffman, H; Avsar, K; Shrestha, B

2016-12-01

German Nepal TB Project, National Tuberculosis Reference Laboratory, Kathmandu, Nepal. To evaluate whether transporting samples in OMNIgene®•SPUTUM (OM-S) reagent from a peripheral collection site to a central laboratory in Nepal can improve tuberculosis (TB) detection and increase the sensitivity of Xpert® MTB/RIF testing. One hundred sputum samples were split manually. Each portion was assigned to the OM-S group (OM-S added at collection, airline-couriered without cold chain, no other processing required) or the standard-of-care (SOC) group (samples airline-couriered on ice, sodium hydroxide + N-acetyl-L-cysteine processing required at the laboratory). Smear microscopy and Xpert testing were performed. Transport time was 2-13 days. Overall smear results were comparable (respectively 58% and 56% smear-negative results in the OM-S and SOC groups). The rate of smear-positive, Mycobacterium tuberculosis-positive (MTB+) sample detection was identical for both treatment groups, at 95%. More smear-negative MTB+ samples were detected in the OM-S group (17% vs. 13%, P = 0.0655). Sputum samples treated with OM-S can undergo multiday ambient-temperature transport and yield comparable smear and Xpert results to those of SOC samples. Further investigation with larger sample sizes is required to assess whether treating sputum samples with OM-S could increase the sensitivity of Xpert testing in smear-negative samples.

[Study of quality of a branch laboratory--an opinion of a laboratory manager].

PubMed

Yazawa, Naoyuki

2006-11-01

At the stage of establishing a branch laboratory, quality evaluation is extremely difficult. Even the results of a control survey by the headquarters of the branch laboratory are unhelpful. For a clinical laboratory, the most important function is to provide reliable data all the time, and to maintain the reliability of clinical doctors with informed responses. We mostly refer to control surveys and daily quality control data to evaluate a clinical laboratory, but we rarely check its fundamental abilities, such as planning events, preserving statistical data about the standard range, using the right method for quality control and others. This is generally disregarded and it is taken for granted that they will be correct the first time. From my six years of experience working with X's branch laboratory, I realized that there might be some relation between the quality of a branch laboratory and the fundamental abilities of the company itself. I would never argue that all branch laboratories are ineffective, but they should be conscious of fundamental activities. The referring laboratory, not the referral laboratory, should be responsible for ensuring that the referral laboratory's examination results and findings are correct.

Exploration geothermal gradient drilling, Platanares, Honduras, Central America

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

Goff, S.J.; Laughlin, A.W.; Ruefenacht, H.D.

1988-01-01

This paper is a review and summary of the core drilling operations component of the Honduras Geothermal Resource Development Project at the Platanares geothermal prospect in Honduras, Central America. Three intermediate depth (428 to 679 m) coreholes are the first continuously cored geothermal exploration boreholes in Honduras. These coring operations are part of the Central America Energy Resource Project (CAERP) effort funded by the Agency for International Development (AID) and implemented by the Los Alamos National Laboratory (Los Alamos) in cooperation with the Empresa Nacional de Energia Electrica (ENEE) and the United States Geological Survey (USGS). This report emphasizes coringmore » operations with reference to the stratigraphy, thermal gradient, and flow test data of the boreholes. The primary objectives of this coring effort were (1) to obtain quantitative information on the temperature distribution as a function of depth, (2) to recover fluids associated with the geothermal reservoir, (3) to recover 75% or better core from the subsurface rock units, and (4) to drill into the subsurface rock as deeply as possible in order to get information on potential reservoir rocks, fracture density, permeabilities, and alteration histories of the rock units beneath the site. The three exploration coreholes drilled to depths of 650, 428 and 679 m, respectively, encountered several hot water entries. Coring operations and associated testing began in mid-October 1986 and were completed at the end of June 1987.« less

Features and dimensions of the Hayward Fault Zone in the Strawberry and Blackberry Creek Area, Berkeley, California

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

Williams, P.L.

1995-03-01

This report presents an examination of the geometry of the Hayward fault adjacent to the Lawrence Berkeley Laboratory and University of California campuses in central Berkeley. The fault crosses inside the eastern border of the UC campus. Most subtle geomorphic (landform) expressions of the fault have been removed by development and by the natural processes of landsliding and erosion. Some clear expressions of the fault remain however, and these are key to mapping the main trace through the campus area. In addition, original geomorphic evidence of the fault`s location was recovered from large scale mapping of the site dating frommore » 1873 to 1897. Before construction obscured and removed natural landforms, the fault was expressed by a linear, northwest-tending zone of fault-related geomorphic features. There existed well-defined and subtle stream offsets and beheaded channels, fault scarps, and a prominent ``shutter ridge``. To improve our confidence in fault locations interpreted from landforms, we referred to clear fault exposures revealed in trenching, revealed during the construction of the Foothill Housing Complex, and revealed along the length of the Lawson Adit mining tunnel. Also utilized were the locations of offset cultural features. At several locations across the study area, distress features in buildings and streets have been used to precisely locate the fault. Recent published mapping of the fault (Lienkaemper, 1992) was principally used for reference to evidence of the fault`s location to the northwest and southeast of Lawrence Berkeley Laboratory.« less

Mining of hospital laboratory information systems: a model study defining age- and gender-specific reference intervals and trajectories for plasma creatinine in a pediatric population.

PubMed

Søeby, Karen; Jensen, Peter Bjødstrup; Werge, Thomas; Sørensen, Steen

2015-09-01

The knowledge of physiological fluctuation and variation of even commonly used biochemical quantities in extreme age groups and during development is sparse. This challenges the clinical interpretation and utility of laboratory tests in these age groups. To explore the utility of hospital laboratory data as a source of information, we analyzed enzymatic plasma creatinine as a model analyte in two large pediatric hospital samples. Plasma creatinine measurements from 9700 children aged 0-18 years were obtained from hospital laboratory databases and partitioned into high-resolution gender- and age-groups. Normal probability plots were used to deduce parameters of the normal distributions from healthy creatinine values in the mixed hospital datasets. Furthermore, temporal trajectories were generated from repeated measurements to examine developmental patterns in periods of changing creatinine levels. Creatinine shows great age dependence from birth throughout childhood. We computed and replicated 95% reference intervals in narrow gender and age bins and showed them to be comparable to those determined in healthy population studies. We identified pronounced transitions in creatinine levels at different time points after birth and around the early teens, which challenges the establishment and usefulness of reference intervals in those age groups. The study documents that hospital laboratory data may inform on the developmental aspects of creatinine, on periods with pronounced heterogeneity and valid reference intervals. Furthermore, part of the heterogeneity in creatinine distribution is likely due to differences in biological and chronological age of children and should be considered when using age-specific reference intervals.

15 CFR 200.104 - Standard reference materials.

Code of Federal Regulations, 2014 CFR

2014-01-01

... the NIST National Measurement Laboratory administers a program to provide many types of well... be readily referred to a common base. NIST SP 260 is a catalog of Standard Reference Materials available from NIST. ...

15 CFR 200.104 - Standard reference materials.

Code of Federal Regulations, 2013 CFR

2013-01-01

... the NIST National Measurement Laboratory administers a program to provide many types of well... be readily referred to a common base. NIST SP 260 is a catalog of Standard Reference Materials available from NIST. ...

15 CFR 200.104 - Standard reference materials.

Code of Federal Regulations, 2011 CFR

2011-01-01

... the NIST National Measurement Laboratory administers a program to provide many types of well... be readily referred to a common base. NIST SP 260 is a catalog of Standard Reference Materials available from NIST. ...

15 CFR 200.104 - Standard reference materials.

Code of Federal Regulations, 2010 CFR

2010-01-01

... the NIST National Measurement Laboratory administers a program to provide many types of well... be readily referred to a common base. NIST SP 260 is a catalog of Standard Reference Materials available from NIST. ...

15 CFR 200.104 - Standard reference materials.

Code of Federal Regulations, 2012 CFR

2012-01-01

... the NIST National Measurement Laboratory administers a program to provide many types of well... be readily referred to a common base. NIST SP 260 is a catalog of Standard Reference Materials available from NIST. ...

Lyme Disease Diagnosed by Alternative Methods: A Phenotype Similar to That of Chronic Fatigue Syndrome.

PubMed

Patrick, David M; Miller, Ruth R; Gardy, Jennifer L; Parker, Shoshana M; Morshed, Muhammad G; Steiner, Theodore S; Singer, Joel; Shojania, Kam; Tang, Patrick

2015-10-01

A subset of patients reporting a diagnosis of Lyme disease can be described as having alternatively diagnosed chronic Lyme syndrome (ADCLS), in which diagnosis is based on laboratory results from a nonreference Lyme specialty laboratory using in-house criteria. Patients with ADCLS report symptoms similar to those reported by patients with chronic fatigue syndrome (CFS). We performed a case-control study comparing patients with ADCLS and CFS to each other and to both healthy controls and controls with systemic lupus erythematosus (SLE). Subjects completed a history, physical exam, screening laboratory tests, 7 functional scales, reference serology for Lyme disease using Centers for Disease Control and Prevention criteria, reference serology for other tick-associated pathogens, and cytokine expression studies. The study enrolled 13 patients with ADCLS (12 of whom were diagnosed by 1 alternative US laboratory), 25 patients with CFS, 25 matched healthy controls, and 11 SLE controls. Baseline clinical data and functional scales indicate significant disability among ADCLS and CFS patients and many important differences between these groups and controls, but no significant differences between each other. No ADCLS patient was confirmed as having positive Lyme serology by reference laboratory testing, and there was no difference in distribution of positive serology for other tick-transmitted pathogens or cytokine expression across the groups. In British Columbia, a setting with low Lyme disease incidence, ADCLS patients have a similar phenotype to that of CFS patients. Disagreement between alternative and reference laboratory Lyme testing results in this setting is most likely explained by false-positive results from the alternative laboratory. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

[Point-of-care-testing--the intensive care laboratory].

PubMed

Müller, M M; Hackl, W; Griesmacher, A

1999-01-01

After successful centralization of laboratory analyses since more than 30 years, advances in biosensors, microprocessors, measurement of undiluted whole blood and miniaturization of laboratory analyzers are leading nowadays more and more to a re-decentralization in the laboratory medicine. Point-of-care-testing (POCT), which is defined as any laboratory test performed outside central or decentralized laboratories, is becoming more and more popular. The theoretical advantages of POCT are faster turn-around-times (TAT), more rapid medical decisions, avoidance of sample identification and sample transport problems and the need of only small specimen volumes. These advantages are frequently mentioned, but are not associated with a clear clinical benefit. The disadvantages of POCT such as incorrect handling and/or maintenance of the analyzers by nontrained clinical staff, inadequate or even absent calibrations and/or quality controls, lack of cost-effectiveness because of an increased number of analyzers and more expensive reagents, insufficient documentation and difficult comparability of the obtained POCT-results with routine laboratory results, are strongly evident. According to the authors' opinion the decision for the establishing of POCT has only to be made in a close co-operation between physicians and laboratorians in order to vouch for necessity and high quality of the analyses. Taking the local situation into consideration (24-h-central laboratory, etc.) the spectrum of parameters measured by means of POCT should be rigorously restricted to the vital functions. Such analytes should be: hemoglobin or hematocrit, activated whole blood clotting time, blood gases, sodium, potassium, ionized calcium, glucose, creatinine, ammonia and lactate.

Optical-Fiber Power Meter Comparison between NIST and KRISS.

PubMed

Vayshenker, I; Kim, S K; Hong, K; Lee, D-H; Livigni, D J; Li, X; Lehman, J H

2012-01-01

We describe the results of a comparison of reference standards between the National Institute of Standards and Technology (NIST-USA) and Korea Research Institute of Standards and Science (KRISS-R.O. Korea) for optical fiber-based power measurements at wavelengths of 1302 nm and 1546 nm. We compare the laboratories' reference standards by means of a temperature-controlled optical trap detector. Measurement results showed the largest difference of less than 2.5 parts in 10(3), which is within the combined standard (k=1) uncertainty for the two laboratories' reference standards.

Optical-Fiber Power Meter Comparison Between NIST and PTB.

PubMed

Vayshenker, I; Haars, H; Li, X; Lehman, J H; Livigni, D J

2003-01-01

We describe the results of a comparison of reference standards between the National Institute of Standards and Technology (NIST-USA) and Physikalisch-Technische Bundesanstalt (PTB-Germany) at nominal wavelengths of 1300 nm and 1550 nm using an optical-fiber cable. Both laboratories used thermal detectors as reference standards. A novel temperature-controlled, optical-trap detector was used as a transfer standard to compare two reference standards. Measurement results showed differences of less than 1.5 × 10(-3), which is within the combined uncertainty for both laboratories.

Structure and biological activity of endogenous and synthetic agonists of GPR119

NASA Astrophysics Data System (ADS)

Tyurenkov, I. N.; Ozerov, A. A.; Kurkin, D. V.; Logvinova, E. O.; Bakulin, D. A.; Volotova, E. V.; Borodin, D. D.

2018-02-01

A G-protein-coupled receptor, GPR119, is a promising pharmacological target for a new class of hypoglycaemic drugs with an original mechanism of action, namely, increase in the glucose-dependent incretin and insulin secretion. In 2005, the first ligands were found and in the subsequent years, a large number of GPR119 agonists were synthesized in laboratories in various countries; the safest and most promising agonists have entered phase I and II clinical trials as agents for the treatment of type 2 diabetes mellitus and obesity. The review describes the major endogenous GPR119 agonists and the main trends in the design and modification of synthetic structures for increasing the hypoglycaemic activity. The data on synthetic agonists are arranged according to the type of the central core of the molecules. The bibliography includes 104 references.

The Palmyra Atoll Research Consortium

USGS Publications Warehouse

Suchanek, Thomas H.

2012-01-01

Palmyra functions as a living laboratory. It is a low-lying coral atoll located about 1,800 kilometers south/southwest of Hawaii near the equator in the central Pacific Ocean (latitude 5°53'N, longitude 162°05'W). Palmyra Atoll and nearby Kingman Reef are U.S. territories and represent the northern atolls/reefs of the U.S. Line Islands. Palmyra also is one of the nine sovereign territories of the United States commonly referred to as the U.S. Pacific Remote Island Areas (PRIAs) that straddle the equator (fig. 1). Palmyra Atoll and nearby Kingman Reef also were included as part of the seven territories that comprise the Pacific Remote Islands Marine National Monument set aside by President Bush in 2009 (Proclamation 8336), which includes the same territories as the PRIAS, except Rose Atoll and Midway Atoll.

Breed-specific reference intervals for assessing thyroid function in seven dog breeds.

PubMed

Hegstad-Davies, Rebecca L; Torres, Sheila M F; Sharkey, Leslie C; Gresch, Sarah C; Muñoz-Zanzi, Claudia A; Davies, Peter R

2015-11-01

Thyroxine (T4), free T4 (FT4), and thyrotropin (TSH) concentrations were measured in serum from 693 healthy representatives from 7 dog breeds (Alaskan Malamute, Collie, English Setter, Golden Retriever, Keeshond, Samoyed, or Siberian Husky) to determine whether breed-specific reference intervals (RIs) are warranted. Veterinarians reviewed the health history, performed a physical examination, and approved laboratory data for the enrolled dogs. Many purebred dogs had T4 and FT4 concentrations that were at, or below, the lower limits previously determined for non-breed-specific RIs. Mean concentrations of T4, FT4, and TSH varied significantly among breeds. The range of mean concentration of T4 (19.7 nmol/L [1.53 µg/dL] in English Setters to 29.0 nmol/L [2.25 µg/dL] in Keeshonds) and FT4 (12.6 pmol/L [0.98 ng/dL] in English Setters to 20.2 pmol/L [1.57 ng/dL] in Samoyeds) was considerable. Median TSH values ranged from 6.10 mIU/L (0.07 ng/mL; Alaskan Malamute and Golden Retriever) to 17.6 mIU/L (0.26 ng/mL; Collie). Mean T4 and FT4 concentrations were higher in females. Increasing age was associated with decreasing T4 and FT4, and increasing TSH concentration. The substantial ranges across breeds of measures of central tendency (mean, median) for all hormones indicate that breed-specific RIs are warranted. RIs encompassing the central 95% of reference values for all breeds combined, and for individual breeds, were calculated using nonparametric (TSH) and robust (T4, FT4) methods. Use of breed-specific RIs in combination with careful attention to the potential for pre-analytical and analytical variability in test results will improve thyroid function assessment in these breeds. © 2015 The Author(s).

Clinical pathology accreditation: standards for the medical laboratory

PubMed Central

Burnett, D; Blair, C; Haeney, M R; Jeffcoate, S L; Scott, K W M; Williams, D L

2002-01-01

This article describes a new set of revised standards for the medical laboratory, which have been produced by Clinical Pathology Accreditation (UK) Ltd (CPA). The original standards have been in use since 1992 and it was recognised that extensive revision was required. A standards revision group was established by CPA and this group used several international standards as source references, so that the resulting new standards are compatible with the most recent international reference sources. The aim is to make the assessment of medical laboratories as objective as possible in the future. CPA plans to introduce these standards in the UK in 2003 following extensive consultation with professional bodies, piloting in selected laboratories, and training of assessors. PMID:12354795

Do Graduate Teaching Assistants Benefit from Teaching Inquiry-Based Laboratories?

ERIC Educational Resources Information Center

French, Donald; Russell, Connie

2002-01-01

Introduces a study investigating graduate teaching assistants' (GTA) perceptions on their role in conducting laboratories and explores the benefits of inquiry-based laboratories for GTAs considering their experiences and knowledge. (Contains 22 references.) (YDS)

Aligning Perceptions of Laboratory Demonstrators' Responsibilities to Inform the Design of a Laboratory Teacher Development Program

ERIC Educational Resources Information Center

Flaherty, Aishling; O'Dwyer, Anne; Mannix-McNamara, Patricia; Leahy, J. J.

2017-01-01

Throughout countries such as Ireland, the U.K., and Australia, graduate students who fulfill teaching roles in the undergraduate laboratory are often referred to as "laboratory demonstrators". The laboratory demonstrator (LD) model of graduate teaching is similar to the more commonly known graduate teaching assistant (GTA) model that is…

Development of a reference material for routine performance monitoring of methods measuring polychlorinated dibenzo-p-dioxins, polychlorinated dibenzofurans and dioxin-like polychlorinated biphenyls.

PubMed

Selliah, S S; Cussion, S; MacPherson, K A; Reiner, E J; Toner, D

2001-06-01

Matrix-matched environmental certified reference materials (CRMs) are one of the most useful tools to validate analytical methods, assess analytical laboratory performance and to assist in the resolution of data conflicts between laboratories. This paper describes the development of a lake sediment as a CRM for polychorinated dibenzo-p-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs) and dioxin-like polychlorinated biphenyls (DLPCBs). The presence of DLPCBs in the environment is of increased concern and analytical methods are being developed internationally for monitoring DLPCBs in the environment. This paper also reports the results of an international interlaboratory study involving thirty-five laboratories from seventeen countries, conducted to characterize and validate levels of a sediment reference material for PCDDs, PCDFs and DLPCBs.

Recent developments in the field of environmental reference materials at the JRC Ispra.

PubMed

Muntau, H

2001-06-01

The production of reference materials for environmental analysis started in the Joint Research Centre at Ispra/Italy in 1972 with the objective of later certification by the BCR, but for obvious budget reasons only a fraction of the total production achieved at Ispra ever reached certification level, although all materials were produced according to the severe quality requirements requested for certified reference materials. Therefore, the materials not destinated to certification are in growing demand as inter-laboratory test materials and as laboratory reference materials, for internal quality control, e.g., by control charts. The history of reference material production within the Joint Research Centre is briefly reviewed and the latest additions described. New developments such as micro-scale reference materials intended for analytical methods requiring sample intakes at milligram or sub-milligram level and therefor not finding supply on the reference material market, and "wet" environmental reference materials, which meet more precisely the "real-world" environmental analysis conditions, are presented and the state-of-the-art discussed.

An overview of the U.S. Army Research Laboratory's Sensor Information Testbed for Collaborative Research Environment (SITCORE) and Automated Online Data Repository (AODR) capabilities

NASA Astrophysics Data System (ADS)

Ward, Dennis W.; Bennett, Kelly W.

2017-05-01

The Sensor Information Testbed COllaberative Research Environment (SITCORE) and the Automated Online Data Repository (AODR) are significant enablers of the U.S. Army Research Laboratory (ARL)'s Open Campus Initiative and together create a highly-collaborative research laboratory and testbed environment focused on sensor data and information fusion. SITCORE creates a virtual research development environment allowing collaboration from other locations, including DoD, industry, academia, and collation facilities. SITCORE combined with AODR provides end-toend algorithm development, experimentation, demonstration, and validation. The AODR enterprise allows the U.S. Army Research Laboratory (ARL), as well as other government organizations, industry, and academia to store and disseminate multiple intelligence (Multi-INT) datasets collected at field exercises and demonstrations, and to facilitate research and development (R and D), and advancement of analytical tools and algorithms supporting the Intelligence, Surveillance, and Reconnaissance (ISR) community. The AODR provides a potential central repository for standards compliant datasets to serve as the "go-to" location for lessons-learned and reference products. Many of the AODR datasets have associated ground truth and other metadata which provides a rich and robust data suite for researchers to develop, test, and refine their algorithms. Researchers download the test data to their own environments using a sophisticated web interface. The AODR allows researchers to request copies of stored datasets and for the government to process the requests and approvals in an automated fashion. Access to the AODR requires two-factor authentication in the form of a Common Access Card (CAC) or External Certificate Authority (ECA)

A guide to utilization of the microbiology laboratory for diagnosis of infectious diseases: 2013 recommendations by the Infectious Diseases Society of America (IDSA) and the American Society for Microbiology (ASM)(a).

PubMed

Baron, Ellen Jo; Miller, J Michael; Weinstein, Melvin P; Richter, Sandra S; Gilligan, Peter H; Thomson, Richard B; Bourbeau, Paul; Carroll, Karen C; Kehl, Sue C; Dunne, W Michael; Robinson-Dunn, Barbara; Schwartzman, Joseph D; Chapin, Kimberle C; Snyder, James W; Forbes, Betty A; Patel, Robin; Rosenblatt, Jon E; Pritt, Bobbi S

2013-08-01

The critical role of the microbiology laboratory in infectious disease diagnosis calls for a close, positive working relationship between the physician and the microbiologists who provide enormous value to the health care team. This document, developed by both laboratory and clinical experts, provides information on which tests are valuable and in which contexts, and on tests that add little or no value for diagnostic decisions. Sections are divided into anatomic systems, including Bloodstream Infections and Infections of the Cardiovascular System, Central Nervous System Infections, Ocular Infections, Soft Tissue Infections of the Head and Neck, Upper Respiratory Infections, Lower Respiratory Tract infections, Infections of the Gastrointestinal Tract, Intraabdominal Infections, Bone and Joint Infections, Urinary Tract Infections, Genital Infections, and Skin and Soft Tissue Infections; or into etiologic agent groups, including Tickborne Infections, Viral Syndromes, and Blood and Tissue Parasite Infections. Each section contains introductory concepts, a summary of key points, and detailed tables that list suspected agents; the most reliable tests to order; the samples (and volumes) to collect in order of preference; specimen transport devices, procedures, times, and temperatures; and detailed notes on specific issues regarding the test methods, such as when tests are likely to require a specialized laboratory or have prolonged turnaround times. There is redundancy among the tables and sections, as many agents and assay choices overlap. The document is intended to serve as a reference to guide physicians in choosing tests that will aid them to diagnose infectious diseases in their patients.

Executive summary: a guide to utilization of the microbiology laboratory for diagnosis of infectious diseases: 2013 recommendations by the Infectious Diseases Society of America (IDSA) and the American Society for Microbiology (ASM)(a).

PubMed

Baron, Ellen Jo; Miller, J Michael; Weinstein, Melvin P; Richter, Sandra S; Gilligan, Peter H; Thomson, Richard B; Bourbeau, Paul; Carroll, Karen C; Kehl, Sue C; Dunne, W Michael; Robinson-Dunn, Barbara; Schwartzman, Joseph D; Chapin, Kimberle C; Snyder, James W; Forbes, Betty A; Patel, Robin; Rosenblatt, Jon E; Pritt, Bobbi S

2013-08-01

The critical role of the microbiology laboratory in infectious disease diagnosis calls for a close, positive working relationship between the physician and the microbiologists who provide enormous value to the health care team. This document, developed by both laboratory and clinical experts, provides information on which tests are valuable and in which contexts, and on tests that add little or no value for diagnostic decisions. Sections are divided into anatomic systems, including Bloodstream Infections and Infections of the Cardiovascular System, Central Nervous System Infections, Ocular Infections, Soft Tissue Infections of the Head and Neck, Upper Respiratory Infections, Lower Respiratory Tract infections, Infections of the Gastrointestinal Tract, Intraabdominal Infections, Bone and Joint Infections, Urinary Tract Infections, Genital Infections, and Skin and Soft Tissue Infections; or into etiologic agent groups, including Tickborne Infections, Viral Syndromes, and Blood and Tissue Parasite Infections. Each section contains introductory concepts, a summary of key points, and detailed tables that list suspected agents; the most reliable tests to order; the samples (and volumes) to collect in order of preference; specimen transport devices, procedures, times, and temperatures; and detailed notes on specific issues regarding the test methods, such as when tests are likely to require a specialized laboratory or have prolonged turnaround times. There is redundancy among the tables and sections, as many agents and assay choices overlap. The document is intended to serve as a reference to guide physicians in choosing tests that will aid them to diagnose infectious diseases in their patients.

A Guide to Utilization of the Microbiology Laboratory for Diagnosis of Infectious Diseases: 2013 Recommendations by the Infectious Diseases Society of America (IDSA) and the American Society for Microbiology (ASM)a

PubMed Central

Baron, Ellen Jo; Miller, J. Michael; Weinstein, Melvin P.; Richter, Sandra S.; Gilligan, Peter H.; Thomson, Richard B.; Bourbeau, Paul; Carroll, Karen C.; Kehl, Sue C.; Dunne, W. Michael; Robinson-Dunn, Barbara; Schwartzman, Joseph D.; Chapin, Kimberle C.; Snyder, James W.; Forbes, Betty A.; Patel, Robin; Rosenblatt, Jon E.; Pritt, Bobbi S.

2013-01-01

The critical role of the microbiology laboratory in infectious disease diagnosis calls for a close, positive working relationship between the physician and the microbiologists who provide enormous value to the health care team. This document, developed by both laboratory and clinical experts, provides information on which tests are valuable and in which contexts, and on tests that add little or no value for diagnostic decisions. Sections are divided into anatomic systems, including Bloodstream Infections and Infections of the Cardiovascular System, Central Nervous System Infections, Ocular Infections, Soft Tissue Infections of the Head and Neck, Upper Respiratory Infections, Lower Respiratory Tract infections, Infections of the Gastrointestinal Tract, Intraabdominal Infections, Bone and Joint Infections, Urinary Tract Infections, Genital Infections, and Skin and Soft Tissue Infections; or into etiologic agent groups, including Tickborne Infections, Viral Syndromes, and Blood and Tissue Parasite Infections. Each section contains introductory concepts, a summary of key points, and detailed tables that list suspected agents; the most reliable tests to order; the samples (and volumes) to collect in order of preference; specimen transport devices, procedures, times, and temperatures; and detailed notes on specific issues regarding the test methods, such as when tests are likely to require a specialized laboratory or have prolonged turnaround times. There is redundancy among the tables and sections, as many agents and assay choices overlap. The document is intended to serve as a reference to guide physicians in choosing tests that will aid them to diagnose infectious diseases in their patients. PMID:23845951

15. VIEW OF LABORATORY EQUIPMENT IN THE BUILDING 771 ANALYTICAL ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

15. VIEW OF LABORATORY EQUIPMENT IN THE BUILDING 771 ANALYTICAL LABORATORY. THE LAB ANALYZED SAMPLES FOR PLUTONIUM, AMERICIUM, URANIUM, NEPTUNIUM, AND OTHER RADIOACTIVE ISOTOPES. (9/25/62) - Rocky Flats Plant, Plutonium Recovery & Fabrication Facility, North-central section of plant, Golden, Jefferson County, CO

TREAT Asia Quality Assessment Scheme (TAQAS) to standardize the outcome of HIV genotypic resistance testing in a group of Asian laboratories

PubMed Central

Land, Sally; Cunningham, Philip; Zhou, Jialun; Frost, Kevin; Katzenstein, David; Kantor, Rami; Chen, Yi-Ming Arthur; Oka, Shinichi; DeLong, Allison; Sayer, David; Smith, Jeffery; Dax, Elizabeth M.; Law, Matthew

2010-01-01

The TREAT Asia (Therapeutics, Research, Education, and AIDS Training in Asia) Network is building capacity for Human Immunodeficiency Virus Type-1 (HIV-1) drug resistance testing in the region. The objective of the TREAT Asia Quality Assessment Scheme – designated TAQAS – is to standardize HIV-1 genotypic resistance testing (HIV genotyping) among laboratories to permit rigorous comparison of results from different clinics and testing centres. TAQAS has evaluated three panels of HIV-1-positive plasma from clinical material or low-passage, culture supernatant for up to 10 Asian laboratories. Laboratory participants used their standard protocols to perform HIV genotyping. Assessment was in comparison to a target genotype derived from all participants and the reference laboratory’s result. Agreement between most participants at the edited nucleotide sequence level was high (>98%). Most participants performed to the reference laboratory standard in detection of drug resistance mutations (DRMs). However, there was variation in the detection of nucleotide mixtures (0–83%) and a significant correlation with the detection of DRMs (p < 0.01). Interpretation of antiretroviral resistance showed ~70% agreement among participants when different interpretation systems were used but >90% agreement with a common interpretation system, within the Stanford University Drug Resistance Database. Using the principles of external quality assessment and a reference laboratory, TAQAS has demonstrated high quality HIV genotyping results from Asian laboratories. PMID:19490972

Status, quality and specific needs of Zika virus (ZIKV) diagnostic capacity and capability in National Reference Laboratories for arboviruses in 30 EU/EEA countries, May 2016

PubMed Central

Mögling, Ramona; Zeller, Hervé; Revez, Joana; Koopmans, Marion; Reusken, Chantal

2017-01-01

With international travel, Zika virus (ZIKV) is introduced to Europe regularly. A country's ability to robustly detect ZIKV introduction and local transmission is important to minimise the risk for a ZIKV outbreak. Therefore, sufficient expertise and diagnostic capacity and capability are required in European laboratories. To assess the capacity, quality, operational specifics (guidelines and algorithms), technical and interpretation issues and other possible difficulties that were related to ZIKV diagnostics in European countries, a questionnaire was conducted among national reference laboratories in 30 countries in the European Union/European Economic Area (EU/EEA) in May 2016. While the coverage and capacity of ZIKV diagnostics in the EU/EEA national reference laboratories were found to be adequate, the assessment of the quality and needs indicated several crucial points of improvement that will need support at national and EU/EEA level to improve ZIKV preparedness, response and EU/EEA ZIKV surveillance activities. PMID:28920574

76 FR 62062 - Proposed Approval of the Central Characterization Project's Remote-Handled Transuranic Waste...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-06

... Central Characterization Project's Remote-Handled Transuranic Waste Characterization Program at Sandia..., remote-handled (RH), transuranic (TRU) waste characterization program implemented by the Central Characterization Project (CCP) at Sandia National Laboratory (SNL) in Albuquerque, New Mexico. This waste is...

76 FR 33277 - Proposed Approval of the Central Characterization Project's Remote-Handled Transuranic Waste...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-08

... Central Characterization Project's Remote-Handled Transuranic Waste Characterization Program at Bettis... radioactive remote-handled (RH) transuranic (TRU) waste characterization program implemented by the Central Characterization Project (CCP) at Bettis Atomic Power Laboratory (BAPL) in West Mifflin, Pennsylvania. This waste...

Hematology and plasma chemistry reference intervals for mature laboratory pine voles (Microtus pinetorum) as determined by using the nonparametric rank percentile method.

PubMed

Harvey, Stephen B; Krimer, Paula M; Correa, Maria T; Hanes, Martha A

2008-07-01

Plasma biochemical and hematologic values are important parameters for assessing animal health and experimental results. Although normal reference values for many rodent species have been published, there is a dearth of similar information for the genus Microtus. In addition, most studies use a mean and standard deviation to establish reference intervals, but doing so is not the recommendation of the Clinical and Laboratory Standards Institute (formerly the National Committee on Clinical Laboratory Standards) or the International Federation of Clinical Chemistry and Laboratory Medicine. The purpose of this study was to establish normal reference parameters for plasma biochemistry and hematology in mature pine voles (Microtus pinetorum) by using the nonparametric rank percentile method as recommended by the 2 laboratory medicine organizations mentioned. Samples of cardiac blood from a closed colony of pine voles were collected at euthanasia and evaluated under rodent settings on 2 automated hematology analyzers from 2 different manufacturers and on the same type of automated biochemistry analyzer. There were no sex-associated clinically significant differences between the sexes; younger animals had a lower hematocrit, higher mean corpuscular volume, and lower mean corpuscular hemoglobin concentration than did older animals. Only platelet counts differed when comparing hematologic values from different analyzers. Relative to rats and mice, pine voles have a lower mean corpuscular volume and higher red blood cell count, higher blood urea nitrogen, much higher alanine aminotransferase, and lower glucose and phosphorous concentrations. Hematology and plasma biochemical results obtained in this study are considered representative for healthy adult laboratory pine voles under similar environmental conditions.

The volcano mouse Neotomodon alstoni of central Mexico, a biological model in the study of breeding, obesity and circadian rhythms.

PubMed

Miranda-Anaya, M; Pérez-Mendoza, M; Juárez-Tapia, C R; Carmona-Castro, A

2018-04-24

The "Mexican volcano mouse" Neotomodon alstoni, is endemic of the Transverse Neovolcanic Ridge in central Mexico. It is considered as least concern species and has been studied as a potential laboratory model from different perspectives. Two lines of research in neuroendocrinology have been addressed: reproduction and parental care, particularly focused on paternal attention and the influence of testosterone, and studies on physiology and behavior of circadian rhythms, focused on the circadian biology of the species, its circadian locomotor activity and daily neuroendocrine regulation of metabolic parameters related to energy balance. Some mice, when captive, spontaneously develop obesity, which allows for comparisons between lean and obese mice of daily changes in neuronal and metabolic parameters associated with changes in food intake and locomotor activity. This review includes studies that consider this species an attractive animal model where the alteration of circadian rhythms influences the pathogenesis of obesity, specifically with the basic regulation of food intake and metabolism and differences related to sex. This study can be considered as a reference to the comparative animal physiology among rodents. Copyright © 2018. Published by Elsevier Inc.

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.

HER2 Status in Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Adenocarcinoma for Entry to the TRIO-013/LOGiC Trial of Lapatinib.

PubMed

Press, Michael F; Ellis, Catherine E; Gagnon, Robert C; Grob, Tobias J; Buyse, Marc; Villalobos, Ivonne; Liang, Zhiyong; Wu, Shafei; Bang, Yung-Jue; Qin, Shu-Kui; Chung, Hyun Cheol; Xu, Jianming; Park, Joon Oh; Jeziorski, Krzysztof; Afenjar, Karen; Ma, Yanling; Estrada, Monica C; Robinson, Douglas M; Scherer, Stefan J; Sauter, Guido; Hecht, J Randolph; Slamon, Dennis J

2017-01-01

HER2/ERBB2 status is used to select patients for HER2-targeted therapy. HER2/ERBB2 amplification/overexpression of upper gastrointestinal (UGI) adenocarcinomas was determined locally or in two central laboratories to select patients for the TRIO-013/LOGiC trial of chemotherapy with or without lapatinib. Patients selected locally had central laboratory confirmation of HER2 amplification for inclusion in the primary efficacy population. HER2 was assessed with PathVysion or IQ PharmDx FISH and HercepTest immunohistochemistry assays. Associations with outcomes were retrospectively evaluated. Overall, HER2 status was determined in UGI cancers from 4,674 patients in a central laboratory for eligibility (1,995 cases) and for confirmation of local HER2 results (333 cases). Of 1,995 adenocarcinomas screened centrally, 322 (16.1%) had HER2-amplified disease with 29 (1.5%) showing HER2 genomic heterogeneity. Men and older patients had higher rates of amplification. Of 545 patients accrued to the trial (gastric, 87.3%; GEJ, 8.3% and esophageal cancer, 4.4%), 487 patients (89%) were centrally confirmed as having HER2-amplified disease. Concordance between central and local HER2 testing was 83%. Concordance between PathVysion and IQ PharmDx FISH assays was 99% and FISH in the two central laboratories was 95%. Lapatinib-treated Asian participants and those less than 60 years had significant improvement in progression-free survival (PFS), particularly among those whose cancers had 5.01-10.0 and >10.0-fold amplification of HER2 In conclusion, HER2 is commonly amplified in UGI adenocarcinomas with amplification highly correlated to overexpression, and HER2 amplification levels correlated with PFS. While HER2 genomic heterogeneity occurs, its prevalence is low. Mol Cancer Ther; 16(1); 228-38. ©2016 AACR. ©2016 American Association for Cancer Research.

WHO Melting-Point Reference Substances

PubMed Central

Bervenmark, H.; Diding, N. Å.; Öhrner, B.

1963-01-01

Batches of 13 highly purified chemicals, intended for use as reference substances in the calibration of apparatus for melting-point determinations, have been subjected to a collaborative assay by 15 laboratories in 13 countries. All the laboratories performed melting-point determinations by the capillary methods described in the proposed text for the second edition of the Pharmacopoea Internationalis and some, in addition, carried out determinations by the microscope hot stage (Kofler) method, using both the “going-through” and the “equilibrium” technique. Statistical analysis of the data obtained by the capillary method showed that the within-laboratory variation was small and that the between-laboratory variation, though constituting the greatest part of the whole variance, was not such as to warrant the exclusion of any laboratory from the evaluation of the results. The average values of the melting-points obtained by the laboratories can therefore be used as constants for the substances in question, which have accordingly been established as WHO Melting-Point Reference Substances and included in the WHO collection of authentic chemical substances. As to the microscope hot stage method, analysis of the results indicated that the values obtained by the “going-through” technique did not differ significantly from those obtained by the capillary method, but the values obtained by the “equilibrium” technique were mostly significantly lower. PMID:20604137

2012 Annual Wastewater Reuse Report for the Idaho National Laboratory Site's Central facilities Area Sewage Treatment Plant

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

Mike Lewis

2013-02-01

This report describes conditions, as required by the state of Idaho Wastewater Reuse Permit (#LA-000141-03), for the wastewater land application site at Idaho National Laboratory Site’s Central Facilities Area Sewage Treatment Plant from November 1, 2011, through October 31, 2012. The report contains the following information: • Site description • Facility and system description • Permit required monitoring data and loading rates • Status of compliance conditions and activities • Discussion of the facility’s environmental impacts. During the 2012 permit year, no wastewater was land-applied to the irrigation area of the Central Facilities Area Sewage Treatment Plant.

Field and laboratory data describing physical and chemical characteristics of metal-contaminated flood-plain deposits downstream from Lead, west-central South Dakota

USGS Publications Warehouse

Marron, D.C.

1988-01-01

Samples from metal-contaminated flood-plain sediments at 9 sites downstream from Lead, in west-central South Dakota, were collected during the summers of 1985-87 to characterize aspects of the sedimentology, chemistry, and geometry of a deposit that resulted from the discharge of a large volume of mining wastes into a river system. Field and laboratory data include stratigraphic descriptions, chemical contents and grain-size distributions of samples, and surveyed flood-plain positions of samples. This report describes sampling-site locations, and methods of sample collection and preservation, and subsequent laboratory analysis. Field and laboratory data are presented in 4 figures and 11 tables in the ' Supplemental Data ' section at the back of the report. (USGS)

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

PubMed

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

2013-03-13

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

Interior. Balance room for chemistry laboratory. Storage room for glassware ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

Interior. Balance room for chemistry laboratory. Storage room for glassware and reference room with frequently used chemistry and chemical engineering texts. - Thomas A. Edison Laboratories, Building No. 2, Main Street & Lakeside Avenue, West Orange, Essex County, NJ

Reference values of brachial-ankle pulse wave velocity according to age and blood pressure in a central Asia population.

PubMed

Yiming, Gulinuer; Zhou, Xianhui; Lv, Wenkui; Peng, Yi; Zhang, Wenhui; Cheng, Xinchun; Li, Yaodong; Xing, Qiang; Zhang, Jianghua; Zhou, Qina; Zhang, Ling; Lu, Yanmei; Wang, Hongli; Tang, Baopeng

2017-01-01

Brachial-ankle pulse wave velocity (baPWV), a direct measure of aortic stiffness, has increasingly become an important assessment for cardiovascular risk. The present study established the reference and normal values of baPWV in a Central Asia population in Xinjiang, China. We recruited participants from a central Asia population in Xinjiang, China. We performed multiple regression analysis to investigate the determinants of baPWV. The median and 10th-90th percentiles were calculated to establish the reference and normal values based on these categories. In total, 5,757 Han participants aged 15-88 years were included in the present study. Spearman correlation analysis showed that age (r = 0.587, p < 0.001) and mean blood pressure (MBP, r = 0.599, p <0.001) were the major factors influencing the values of baPWV in the reference population. Furthermore, in the multiple linear regression analysis, the standardized regression coefficients of age (0.445) and MBP (0.460) were much higher than those of body mass index, triglyceride, and glycemia (-0.054, 0.035, and 0.033, respectively). In the covariance analysis, after adjustment for age and MBP, only diabetes was the significant independent determinant of baPWV (p = 0.009). Thus, participants with diabetes were excluded from the reference value population. The reference values ranged from 14.3 to 25.2 m/s, and the normal values ranged from 13.9 to 21.2 m/s. This is the first study that has established the reference and normal values for baPWV according to age and blood pressure in a Central Asia population.

The Effect of Motion Analysis Activities in a Video-Based Laboratory in Students' Understanding of Position, Velocity and Frames of Reference

ERIC Educational Resources Information Center

Koleza, Eugenia; Pappas, John

2008-01-01

In this article, we present the results of a qualitative research project on the effect of motion analysis activities in a Video-Based Laboratory (VBL) on students' understanding of position, velocity and frames of reference. The participants in our research were 48 pre-service teachers enrolled in Education Departments with no previous strong…

Reference intervals: current status, recent developments and future considerations.

PubMed

Ozarda, Yesim

2016-01-01

Reliable and accurate reference intervals (RIs) for laboratory analyses are an integral part of the process of correct interpretation of clinical laboratory test results. RIs given in laboratory reports have an important role in aiding the clinician in interpreting test results in reference to values for healthy populations. Since the 1980s, the International Federation of Clinical Chemistry (IFCC) has been proactive in establishing recommendations to clarify the true significance of the term 'RIs, to select the appropriate reference population and statistically analyse the data. The C28-A3 guideline published by the Clinical and Laboratory Standards Institute (CLSI) and IFCC is still the most widely-used source of reference in this area. In recent years, protocols additional to the Guideline have been published by the IFCC, Committee on Reference Intervals and Decision Limits (C-RIDL), including all details of multicenter studies on RIs to meet the requirements in this area. Multicentric RIs studies are the most important development in the area of RIs. Recently, the C-RIDL has performed many multicentric studies to obtain common RIs. Confusion of RIs and clinical decision limits (CDLs) remains an issue and pediatric and geriatric age groups are a significant problem. For future studies of RIs, the genetic effect would seem to be the most challenging area. 
The aim of the review is to present the current theory and practice of RIs, with special emphasis given to multicenter RIs studies, RIs studies for pediatric and geriatric age groups, clinical decision limits and partitioning by genetic effects on RIs.

Reference intervals: current status, recent developments and future considerations

PubMed Central

Ozarda, Yesim

2016-01-01

Reliable and accurate reference intervals (RIs) for laboratory analyses are an integral part of the process of correct interpretation of clinical laboratory test results. RIs given in laboratory reports have an important role in aiding the clinician in interpreting test results in reference to values for healthy populations. Since the 1980s, the International Federation of Clinical Chemistry (IFCC) has been proactive in establishing recommendations to clarify the true significance of the term ‘RIs, to select the appropriate reference population and statistically analyse the data. The C28-A3 guideline published by the Clinical and Laboratory Standards Institute (CLSI) and IFCC is still the most widely-used source of reference in this area. In recent years, protocols additional to the Guideline have been published by the IFCC, Committee on Reference Intervals and Decision Limits (C-RIDL), including all details of multicenter studies on RIs to meet the requirements in this area. Multicentric RIs studies are the most important development in the area of RIs. Recently, the C-RIDL has performed many multicentric studies to obtain common RIs. Confusion of RIs and clinical decision limits (CDLs) remains an issue and pediatric and geriatric age groups are a significant problem. For future studies of RIs, the genetic effect would seem to be the most challenging area.
The aim of the review is to present the current theory and practice of RIs, with special emphasis given to multicenter RIs studies, RIs studies for pediatric and geriatric age groups, clinical decision limits and partitioning by genetic effects on RIs. PMID:26981015

Conventional early infant diagnosis in Lesotho from specimen collection to results usage to manage patients: Where are the bottlenecks?

PubMed Central

Hoffman, Heather J.; Isavwa, Anthony; Mokone, Mafusi; Foso, Matokelo; Safrit, Jeffrey T.; Mofenson, Lynne M.; Tylleskär, Thorkild

2017-01-01

Introduction Early infant diagnosis is an important step in identifying children infected with HIV during the perinatal period or in utero. Multiple factors contribute to delayed antiretroviral treatment initiation for HIV-infected children, including delays in the early infant HIV diagnosis cascade. Methods We conducted a retrospective study to evaluate early infant diagnosis turnaround times in Lesotho. Trained staff reviewed records of HIV-exposed infants (aged-6-8 weeks) who received an HIV test during 2011. Study sites were drawn from Highlands, Foothills and Lowlands regions of Lesotho. Central laboratory database data were linked to facility and laboratory register information. Turnaround time geometric means (with 95% CI) were calculated and compared by region using linear mixed models. Results 1,187 individual infant records from 25 facilities were reviewed. Overall, early infant diagnosis turnaround time was 61.7 days (95%CI: 55.3–68.7). Mean time from specimen collection to district laboratory was 14 days (95%CI: 12.1–16.1); from district to central laboratory, 2 days (95%CI 0.8–5.2); results from central laboratory to district hospital, 23.3 days (95%CI: 18.7–29.0); from district hospital to health facility, 3.2 days (95%CI 1.9–5.5); and from health facility to caregiver, 10.4 days (95%CI, 7.9–13.5). Mean times from specimen transfer to the central laboratory and for result transfer from central laboratory to district hospital were significantly shorter in the Lowlands Region (0.9 and 16.2 days, respectively), compared to Highlands Region (6.0 [P = 0.030] and 34.3 days [P = 0.0099]. Turnaround time from blood draw to receipt of results was significantly shorter for HIV infected infants compared to HIV uninfected infants [p = 0.0036] at an average of 47.1 days (95%CI: 38.9–56.9) and 62 days (95%CI: 55.9–68.7) respectively. Of 47 HIV-infected infants, 36 were initiated on antiretroviral therapy at an average of 1.3 days (95%CI: 0.3, 5.7) after caregiver received the result. Conclusion HIV-infected infants received results earlier and were rapidly initiated on antiretroviral therapy once the result was delivered to caregiver. However, average early infant diagnosis turnaround time was two months; the longest period of delay was transfer of results from central laboratory to district hospital. Turnaround time of results based on geographical regions or between hospitals and health centres varied but did not reach statistical significance. PMID:29016634

CLSI-derived hematology and biochemistry reference intervals for healthy adults in eastern and southern Africa.

PubMed

Karita, Etienne; Ketter, Nzeera; Price, Matt A; Kayitenkore, Kayitesi; Kaleebu, Pontiano; Nanvubya, Annet; Anzala, Omu; Jaoko, Walter; Mutua, Gaudensia; Ruzagira, Eugene; Mulenga, Joseph; Sanders, Eduard J; Mwangome, Mary; Allen, Susan; Bwanika, Agnes; Bahemuka, Ubaldo; Awuondo, Ken; Omosa, Gloria; Farah, Bashir; Amornkul, Pauli; Birungi, Josephine; Yates, Sarah; Stoll-Johnson, Lisa; Gilmour, Jill; Stevens, Gwynn; Shutes, Erin; Manigart, Olivier; Hughes, Peter; Dally, Len; Scott, Janet; Stevens, Wendy; Fast, Pat; Kamali, Anatoli

2009-01-01

Clinical laboratory reference intervals have not been established in many African countries, and non-local intervals are commonly used in clinical trials to screen and monitor adverse events (AEs) among African participants. Using laboratory reference intervals derived from other populations excludes potential trial volunteers in Africa and makes AE assessment challenging. The objective of this study was to establish clinical laboratory reference intervals for 25 hematology, immunology and biochemistry values among healthy African adults typical of those who might join a clinical trial. Equal proportions of men and women were invited to participate in a cross sectional study at seven clinical centers (Kigali, Rwanda; Masaka and Entebbe, Uganda; two in Nairobi and one in Kilifi, Kenya; and Lusaka, Zambia). All laboratories used hematology, immunology and biochemistry analyzers validated by an independent clinical laboratory. Clinical and Laboratory Standards Institute guidelines were followed to create study consensus intervals. For comparison, AE grading criteria published by the U.S. National Institute of Allergy and Infectious Diseases Division of AIDS (DAIDS) and other U.S. reference intervals were used. 2,990 potential volunteers were screened, and 2,105 (1,083 men and 1,022 women) were included in the analysis. While some significant gender and regional differences were observed, creating consensus African study intervals from the complete data was possible for 18 of the 25 analytes. Compared to reference intervals from the U.S., we found lower hematocrit and hemoglobin levels, particularly among women, lower white blood cell and neutrophil counts, and lower amylase. Both genders had elevated eosinophil counts, immunoglobulin G, total and direct bilirubin, lactate dehydrogenase and creatine phosphokinase, the latter being more pronounced among women. When graded against U.S. -derived DAIDS AE grading criteria, we observed 774 (35.3%) volunteers with grade one or higher results; 314 (14.9%) had elevated total bilirubin, and 201 (9.6%) had low neutrophil counts. These otherwise healthy volunteers would be excluded or would require special exemption to participate in many clinical trials. To accelerate clinical trials in Africa, and to improve their scientific validity, locally appropriate reference ranges should be used. This study provides ranges that will inform inclusion criteria and evaluation of adverse events for studies in these regions of Africa.

Using Pulsed Power for Hydrodynamic Code Validation

DTIC Science & Technology

2001-06-01

Air Force Research Laboratory ( AFRL ). A...bank at the Air Force Research Laboratory ( AFRL ). A cylindrical aluminum liner that is magnetically imploded onto a central target by self-induced...James Degnan, George Kiuttu Air Force Research Laboratory Albuquerque, NM 87117 Abstract As part of ongoing hydrodynamic code

Interlaboratory Reproducibility of Droplet Digital Polymerase Chain Reaction Using a New DNA Reference Material Format.

PubMed

Pinheiro, Leonardo B; O'Brien, Helen; Druce, Julian; Do, Hongdo; Kay, Pippa; Daniels, Marissa; You, Jingjing; Burke, Daniel; Griffiths, Kate; Emslie, Kerry R

2017-11-07

Use of droplet digital PCR technology (ddPCR) is expanding rapidly in the diversity of applications and number of users around the world. Access to relatively simple and affordable commercial ddPCR technology has attracted wide interest in use of this technology as a molecular diagnostic tool. For ddPCR to effectively transition to a molecular diagnostic setting requires processes for method validation and verification and demonstration of reproducible instrument performance. In this study, we describe the development and characterization of a DNA reference material (NMI NA008 High GC reference material) comprising a challenging methylated GC-rich DNA template under a novel 96-well microplate format. A scalable process using high precision acoustic dispensing technology was validated to produce the DNA reference material with a certified reference value expressed in amount of DNA molecules per well. An interlaboratory study, conducted using blinded NA008 High GC reference material to assess reproducibility among seven independent laboratories demonstrated less than 4.5% reproducibility relative standard deviation. With the exclusion of one laboratory, laboratories had appropriate technical competency, fully functional instrumentation, and suitable reagents to perform accurate ddPCR based DNA quantification measurements at the time of the study. The study results confirmed that NA008 High GC reference material is fit for the purpose of being used for quality control of ddPCR systems, consumables, instrumentation, and workflow.

NASA's DC-8 flying laboratory takes off from Juan Santamaria International Airport in San Jose, Costa Rica, on NASA's AirSAR 2004 campaign

NASA Image and Video Library

2004-03-06

NASA's DC-8 flying laboratory takes off from Juan Santamaria International Airport in San Jose, Costa Rica, on NASA's AirSAR 2004 campaign. AirSAR 2004 Mesoamerica is a three-week expedition by an international team of scientists that uses an all-weather imaging tool, called the Airborne Synthetic Aperture Radar (AirSAR) which is located onboard NASA's DC-8 airborne laboratory. Scientists from many parts of the world including NASA's Jet Propulsion Laboratory are combining ground research done in several areas in Central America with NASA's AirSAR technology to improve and expand on the quality of research they are able to conduct. The radar, developed by NASA's Jet Propulsion Laboratory, can penetrate clouds and also collect data at night. Its high-resolution sensors operate at multiple wavelengths and modes, allowing AirSAR to see beneath treetops, through thin sand, and dry snow pack. AirSAR's 2004 campaign is a collaboration of many U.S. and Central American institutions and scientists, including NASA; the National Science Foundation; the Smithsonian Institution; National Geographic; Conservation International; the Organization of Tropical Studies; the Central American Commission for Environment and Development; and the Inter-American Development Bank.

Strategies of organization and service for the critical-care laboratory.

PubMed

Fleisher, M; Schwartz, M K

1990-08-01

Critical-care medicine requires rapidity of treatment decisions and clinical management. To meet the objectives of critical-care medicine, the critical-care laboratory must consider four major aspects of laboratory organization in addition to analytical responsibilities: specimen collection and delivery, training of technologists, selection of reliable instrumentation, and efficient data dissemination. One must also consider the advantages and disadvantages of centralization vs decentralization, the influence of such a laboratory on patient care and personnel needs, and the space required for optimal operation. Centralization may lead to workflow interruption and increased turnaround time (TAT); decentralization requires redundancy of instrumentation and staff but may shorten TAT. Minimal TAT is the hallmark of efficient laboratory service. We surveyed 55 laboratories in 33 hospitals and found that virtually all hospitals with 200 or more beds had a critical-care laboratory operating as a satellite of the main laboratory. We present data on actual TAT, although these were available in only eight of the 15 routine laboratories that provided emergency service and in eight of the 40 critical-care laboratories. In meeting the challenges of an increasing workload, a reduced clinical laboratory work force, and the need to reduce TAT, changes in traditional laboratory practice are mandatory. An increased reliance on whole-blood analysis, for example, should eliminate delays associated with sample preparation, reduce the potential hazards associated with centrifugation, and eliminate excess specimen handling.

Evolution in a centralized transfusion service.

PubMed

AuBuchon, James P; Linauts, Sandra; Vaughan, Mimi; Wagner, Jeffrey; Delaney, Meghan; Nester, Theresa

2011-12-01

The metropolitan Seattle area has utilized a centralized transfusion service model throughout the modern era of blood banking. This approach has used four laboratories to serve over 20 hospitals and clinics, providing greater capabilities for all at a lower consumption of resources than if each depended on its own laboratory and staff for these functions. In addition, this centralized model has facilitated wider use of the medical capabilities of the blood center's physicians, and a county-wide network of transfusion safety officers is now being developed to increase the impact of the blood center's transfusion expertise at the patient's bedside. Medical expectations and traffic have led the blood center to evolve the centralized model to include on-site laboratories at facilities with complex transfusion requirements (e.g., a children's hospital) and to implement in all the others a system of remote allocation. This new capability places a refrigerator stocked with uncrossmatched units in the hospital but retains control over the dispensing of these through the blood center's computer system; the correct unit can be electronically cross-matched and released on demand, obviating the need for transportation to the hospital and thus speeding transfusion. This centralized transfusion model has withstood the test of time and continues to evolve to meet new situations and ensure optimal patient care. © 2011 American Association of Blood Banks.

Shingles Transmission

MedlinePlus

... Clinical Overview Diagnosis & Testing Prevention in Health Care Settings Laboratory Testing Collecting VZV Specimens CDC National VZV Laboratory Surveillance Resources & References Multimedia Related Links Medline Plus NIH SeniorHealth ...

Performance of serological tests for syphilis in sexually transmitted diseases clinics in Guangxi Autonomous Region, China: implications for syphilis surveillance and control.

PubMed

Yin, Yue-Ping; Wei, Wan-Hui; Wang, Hong-Chun; Zhu, Bang-Yong; Yu, Yan-Hua; Chen, Xiang-Sheng; Peeling, Rosanna W; Cohen, Myron S

2009-03-01

China is experiencing a growing syphilis epidemic. Individuals are currently screened and cases are confirmed using traditional serological testing methods. A total of 11 558 serum specimens from patients at 14 sexually transmitted diseases (STD) clinics at provincial, prefecture and county levels in Guangxi Autonomous Region were tested at local clinics using the toluidine red unheated serum test (TRUST) and the SD Bioline Syphilis 3.0 Treponema Pallidum (SD-TP) test and then transported to the National STD Reference Laboratory for TRUST and confirmatory Treponema pallidum particle assay (TPPA) testing. In local clinics, 13.2% of specimens were TRUST positive and 12.8% were TRUST and SD-TP positive. At the Reference Laboratory, 15.4% of specimens were TRUST positive and 11.8% were TRUST and TPPA positive. Local clinics showed a significantly higher prevalence of active syphilis compared with results from the Reference Laboratory (12.8 v. 11.8%, chi(2) = 4.59, P = 0.03). The local TRUST tests had consistent results with Reference Laboratory tests qualitatively among 96.2% of the specimens and quantitatively among 95.5% of the specimens. The algorithm of TRUST screening and then SD-TP confirmation among positive TRUST specimens at local STD clinics had 96.6% sensitivity and 99.3% specificity in diagnosing active syphilis compared with the 'gold standard' based on TRUST and TPPA positivity at the Reference Laboratory (positive predictive value 95.1% and negative predictive value 99.5%). The TRUST screening and SD-TP confirmation in combination can be used at local STD clinics for the efficient diagnosis of serologically active syphilis. However, continuing capacity building and quality assurance remain critical in ensuring the quality of syphilis diagnosis at local clinics.

Measurement uncertainty: Friend or foe?

PubMed

Infusino, Ilenia; Panteghini, Mauro

2018-02-02

The definition and enforcement of a reference measurement system, based on the implementation of metrological traceability of patients' results to higher order reference methods and materials, together with a clinically acceptable level of measurement uncertainty, are fundamental requirements to produce accurate and equivalent laboratory results. The uncertainty associated with each step of the traceability chain should be governed to obtain a final combined uncertainty on clinical samples fulfilling the requested performance specifications. It is important that end-users (i.e., clinical laboratory) may know and verify how in vitro diagnostics (IVD) manufacturers have implemented the traceability of their calibrators and estimated the corresponding uncertainty. However, full information about traceability and combined uncertainty of calibrators is currently very difficult to obtain. Laboratory professionals should investigate the need to reduce the uncertainty of the higher order metrological references and/or to increase the precision of commercial measuring systems. Accordingly, the measurement uncertainty should not be considered a parameter to be calculated by clinical laboratories just to fulfil the accreditation standards, but it must become a key quality indicator to describe both the performance of an IVD measuring system and the laboratory itself. Copyright © 2018 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Safety in the Chemical Laboratory: Learning How to Run Safer Undergraduate Laboratories.

ERIC Educational Resources Information Center

Mohrig, Jerry R.

1983-01-01

Discusses responsibilities for providing safe experiments and for teaching about safety. Provides lists of references on chemical safety and regulated/potential carcinogens. Also discusses general laboratory safety procedures including waste disposal and recycling of solvents. (JM)

Sources and performance criteria of uncertainty of reference measurement procedures.

PubMed

Mosca, Andrea; Paleari, Renata

2018-05-29

This article wants to focus on the today available Reference Measurement Procedures (RMPs) for the determination of various analytes in Laboratory Medicine and the possible tools to evaluate their performance in the laboratories who are currently using them. A brief review on the RMPs has been performed by investigating the Joint Committee for Traceability in Laboratory Medicine (JCTLM) database. In order to evaluate their performances, we have checked the organization of three international ring trials, i.e. those regularly performed by the IFCC External Quality assessment scheme for Reference Laboratories in Laboratory Medicine (RELA), by the Center for Disease Control and Prevention (CDC) cholesterol network and by the IFCC Network for HbA 1c . Several RMPs are available through the JCTLM database, but the best way to collect information about the RMPs and their uncertainties is to look at the reference measurement service providers (RMS). This part of the database and the background on how to listed in the database is very helpful for the assessment of expanded uncertainty (MU) and performance in general of RMPs. Worldwide, 17 RMS are listed in the database, and for most of the measurands more than one RMS is able to run the relative RMPs, with similar expanded uncertainties. As an example, for a-amylase, 4 SP offer their services with MU between 1.6 and 3.3%. In other cases (such as total cholesterol, the U may span over a broader range, i.e. from 0.02 to 3.6%). With regard to the performance evaluation, the approach is often heterogenous, and it is difficult to compare the performance of laboratories running the same RMP for the same measurand if involved in more than one EQAS. The reference measurement services have been created to help laboratory professionals and manufacturers to implement the correct metrological traceability, and the JCTLM database is the only correct way to retrieve all the necessary important information to this end. Copyright © 2018 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Diabetes insipidus - central

MedlinePlus

... Alternative Names Central diabetes insipidus; Neurogenic diabetes insipidus Images Endocrine glands References Brimioulle S. Diabetes insipidus. In: Vincent J-L, Abraham E, Moore FA, Kochanek PM, Fink ...

Central Core Laboratory versus Site Interpretation of Coronary CT Angiography: Agreement and Association with Cardiovascular Events in the PROMISE Trial.

PubMed

Lu, Michael T; Meyersohn, Nandini M; Mayrhofer, Thomas; Bittner, Daniel O; Emami, Hamed; Puchner, Stefan B; Foldyna, Borek; Mueller, Martin E; Hearne, Steven; Yang, Clifford; Achenbach, Stephan; Truong, Quynh A; Ghoshhajra, Brian B; Patel, Manesh R; Ferencik, Maros; Douglas, Pamela S; Hoffmann, Udo

2018-04-01

Purpose To assess concordance and relative prognostic utility between central core laboratory and local site interpretation for significant coronary artery disease (CAD) and cardiovascular events. Materials and Methods In the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial, readers at 193 North American sites interpreted coronary computed tomographic (CT) angiography as part of the clinical evaluation of stable chest pain. Readers at a central core laboratory also interpreted CT angiography blinded to clinical data, site interpretation, and outcomes. Significant CAD was defined as stenosis greater than or equal to 50%; cardiovascular events were defined as a composite of cardiovascular death or myocardial infarction. Results In 4347 patients (51.8% women; mean age ± standard deviation, 60.4 years ± 8.2), core laboratory and site interpretations were discordant in 16% (683 of 4347), most commonly because of a finding of significant CAD by site but not by core laboratory interpretation (80%, 544 of 683). Overall, core laboratory interpretation resulted in 41% fewer patients being reported as having significant CAD (14%, 595 of 4347 vs 23%, 1000 of 4347; P < .001). Over a median follow-up period of 25 months, 1.3% (57 of 4347) sustained myocardial infarction or cardiovascular death. The C statistic for future myocardial infarction or cardiovascular death was 0.61 (95% confidence interval [CI]: 0.54, 0.68) for the core laboratory and 0.63 (95% CI: 0.56, 0.70) for the sites. Conclusion Compared with interpretation by readers at 193 North American sites, standardized core laboratory interpretation classified 41% fewer patients as having significant CAD. © RSNA, 2017 Online supplemental material is available for this article. Clinical trial registration no. NCT01174550.

Lab Plays Central Role in Groundbreaking National Clinical Trial in Precision Medicine | Frederick National Laboratory for Cancer Research

Cancer.gov

The Molecular Characterization Laboratory at the Frederick National Laboratory for Cancer Research lies at the heart of an ambitious new approach for testing cancer drugs that will use the newest tools of precision medicine to select the best treatme

Clinical utility of Abbott Precision Xceed Pro® ketone meter in diabetic patients.

PubMed

Yu, Hoi-Ying Elsie; Agus, Michael; Kellogg, Mark D

2011-11-01

Diagnosis and management of diabetic ketoacidosis (DKA) often rely on the measurement of urine ketones along with blood glucose, anion gap, and pH. These values, however, do not reliably reflect the severity of ketoacidosis. The Abbott Precision Xceed Pro® meter is an FDA-approved device that quantitatively measures β-hydroxybutyrate (BOH) in whole blood. This study was undertaken to determine whether the ketone meter meets the analytical criteria to aid DKA diagnosis and management in the hospital. 54 heparinized venous whole blood BOH concentrations from 27 diabetic patients were measured by the Abbott meter, and compared with the plasma BOH concentrations measured with Stanbio reagent (reference method). Measurements were done in the hospital central laboratory. Of the 54 pairs of specimens analyzed, 17 pairs displayed a difference of >15% between the two methods. Nearly all discrepant points occurred when BOH >5 mmol/L (reference method). Linearity evaluation revealed that the meter is not linear from 0.0 to 8.0 mmol/L, contrary to the claim by the manufacturer. Further, we identified acetoacetate, a metabolite commonly present in DKA patients, as a potential interfering substance for the meter BOH measurement. BOH measurements by the Abbott meter up to 3 mmol/L correlate well with the reference method, but become discrepant above that point. While this characteristic may be useful in the diagnosis of DKA, it may not allow clinicians to serially follow the response to therapy in hospitalized DKA patients with BOH values greater than 5 mmol/L (reference method). © 2011 John Wiley & Sons A/S.

Human epidermal growth factor receptor 2 assessment in a case-control study: comparison of fluorescence in situ hybridization and quantitative reverse transcription polymerase chain reaction performed by central laboratories.

PubMed

Baehner, Frederick L; Achacoso, Ninah; Maddala, Tara; Shak, Steve; Quesenberry, Charles P; Goldstein, Lynn C; Gown, Allen M; Habel, Laurel A

2010-10-01

The optimal method to assess human epidermal growth factor receptor 2 (HER2) status remains highly controversial. Before reporting patient HER2 results, American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines mandate that laboratories demonstrate ≥ 95% concordance to another approved laboratory or methodology. Here, we compare central laboratory HER2 assessed by fluorescence in situ hybridization (FISH) and quantitative reverse transcriptase polymerase chain reaction (RT-PCR) using Oncotype DX in lymph node-negative, chemotherapy-untreated patients from a large Kaiser Permanente case-control study. Breast cancer specimens from the Kaiser-Genomic Health study were examined. Central FISH assessment of HER2 amplification and polysomy 17 was conducted by PhenoPath Laboratories (ratios > 2.2, 1.8 to 2.2, and < 1.8 define HER2 positive, HER2 equivocal, and HER2 negative, respectively). HER2 expression by RT-PCR was conducted using Oncotype DX by Genomic Health (normalized expression units ≥ 11.5, 10.7 to < 11.5, and < 10.7 define HER2 positive, HER2 equivocal, and HER2 negative, respectively). Concordance analyses followed ASCO/CAP guidelines. HER2 concordance by central FISH and central RT-PCR was 97% (95% CI, 96% to 99%). Twelve percent (67 of 568 patients) and 11% (60 of 568 patients) of patients were HER2 positive by RT-PCR and FISH, respectively. HER2-positive patients had increased odds of dying from breast cancer compared with HER2-negative patients. Polysomy 17 was demonstrated in 12.5% of all patients and 33% of FISH-positive patients. Nineteen of 20 FISH-positive patients with polysomy 17 were also RT-PCR HER2 positive. Although not statistically significantly different, HER2-positive/polysomy 17 patients tended to have the worst prognosis, followed by HER2-positive/eusomic, HER2-negative/polysomy 17, and HER2-negative/eusomic patients. There is a high degree of concordance between central FISH and quantitative RT-PCR using Oncotype DX for HER2 status, and the assay warrants additional study in a trastuzumab-treated population.

An online paradigm for exploring the self-reference effect

PubMed Central

Bentley, Sarah V.; Greenaway, Katharine H.; Haslam, S. Alexander

2017-01-01

People reliably encode information more effectively when it is related in some way to the self—a phenomenon known as the self-reference effect. This effect has been recognized in psychological research for almost 40 years, and its scope as a tool for investigating the self-concept is still expanding. The self-reference effect has been used within a broad range of psychological research, from cultural to neuroscientific, cognitive to clinical. Traditionally, the self-reference effect has been investigated in a laboratory context, which limits its applicability in non-laboratory samples. This paper introduces an online version of the self-referential encoding paradigm that yields reliable effects in an easy-to-administer procedure. Across four studies (total N = 658), this new online tool reliably replicated the traditional self-reference effect: in all studies self-referentially encoded words were recalled significantly more than semantically encoded words (d = 0.63). Moreover, the effect sizes obtained with this online tool are similar to those obtained in laboratory samples, and are robust to experimental variations in encoding time (Studies 1 and 2) and recall procedure (Studies 3 and 4), and persist independent of primacy and recency effects (all studies). PMID:28472160

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.

About Region 8’s Central Regional Laboratory

EPA Pesticide Factsheets

The Region 8 laboratory plays a critical role in protecting people's health and the environment through the analysis of air, water, soil, and biota samples (plant, fish, and occasionally, mammalian tissue).

Complex reference values for endocrine and special chemistry biomarkers across pediatric, adult, and geriatric ages: establishment of robust pediatric and adult reference intervals on the basis of the Canadian Health Measures Survey.

PubMed

Adeli, Khosrow; Higgins, Victoria; Nieuwesteeg, Michelle; Raizman, Joshua E; Chen, Yunqi; Wong, Suzy L; Blais, David

2015-08-01

Defining laboratory biomarker reference values in a healthy population and understanding the fluctuations in biomarker concentrations throughout life and between sexes are critical to clinical interpretation of laboratory test results in different disease states. The Canadian Health Measures Survey (CHMS) has collected blood samples and health information from the Canadian household population. In collaboration with the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER), the data have been analyzed to determine reference value distributions and reference intervals for several endocrine and special chemistry biomarkers in pediatric, adult, and geriatric age groups. CHMS collected data and blood samples from thousands of community participants aged 3 to 79 years. We used serum samples to measure 13 immunoassay-based special chemistry and endocrine markers. We assessed reference value distributions and, after excluding outliers, calculated age- and sex-specific reference intervals, along with corresponding 90% CIs, according to CLSI C28-A3 guidelines. We observed fluctuations in biomarker reference values across the pediatric, adult, and geriatric age range, with stratification required on the basis of age for all analytes. Additional sex partitions were required for apolipoprotein AI, homocysteine, ferritin, and high sensitivity C-reactive protein. The unique collaboration between CALIPER and CHMS has enabled, for the first time, a detailed examination of the changes in various immunochemical markers that occur in healthy individuals of different ages. The robust age- and sex-specific reference intervals established in this study provide insight into the complex biological changes that take place throughout development and aging and will contribute to improved clinical test interpretation. © 2015 American Association for Clinical Chemistry.

Operation of pneumococcal polysaccharide radioimmunoassay reference laboratory: coordination of the serological aspects of otitis media field trials. Annual report 28 Jun 77--27 Jun 78

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

Schiffman, G.

1978-04-03

The contract supports a serologic reference laboratory for the performance of radioimmunoassay of antibodies to pneumococcal polysaccharides. Antibody assays have been performed for a number of investigators studying the response of humans to pneumococcal vaccines. In addition, a large quantity of labeled polysaccharides for use in the assay have been prepared and stored.

Managing Inadvertent Arterial Catheterization During Central Venous Access Procedures

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

Nicholson, Tony, E-mail: Tony.Nicholson@leedsth.nhs.uk; Ettles, Duncan; Robinson, Graham

2004-01-15

Purpose: Approximately 200,000 central venous catheterizations are carried out annually in the National Health Service in the United Kingdom. Inadvertent arterial puncture occurs in up to 3.7%. Significant morbidity and death has been reported. We report on our experience in the endovascular treatment of this iatrogenic complication. Methods: Retrospective analysis was carried out of 9 cases referred for endovascular treatment of inadvertent arterial puncture during central venous catheterization over a 5 year period. Results: It was not possible to obtain accurate figures on the numbers of central venous catheterizations carried out during the time period. Five patients were referred withmore » carotid or subclavian pseudoaneurysms and hemothorax following inadvertent arterial catheter insertion and subsequent removal. These patients all underwent percutaneous balloon tamponade and/or stent-graft insertion. More recently 4 patients were referred with the catheter still in situ and were successfully treated with a percutaneous closure device. Conclusion: If inadvertent arterial catheterization during central venous access procedures is recognized and catheters removed, sequelae can be treated percutaneously. However, once the complication is recognized it is better to leave the catheter in situ and seal the artery percutaneously with a closure device.« less

[Unnecessary routine laboratory tests in patients referred for surgical services].

PubMed

Mata-Miranda, María del Pilar; Cano-Matus, Norberto; Rodriguez-Murrieta, Margarita; Guarneros-Zapata, Idalia; Ortiz, Mario

2016-01-01

To question the usefulness of the lab analysis considered routine testing for the identification of abnormalities in the surgical care. To determine the percentage of unnecessary laboratory tests in the preoperative assessment as well as to estimate the unnecessary expenses. A descriptive, cross-sectional study of patients referred for surgical evaluation between January 1st and March 31st 2013. The database of laboratory testing and electronic files were reviewed. Reference criteria from surgical services were compared with the tests requested by the family doctor. In 65% of the patients (n=175) unnecessary examinations were requested, 25% (n=68) were not requested the tests that they required, and only 10% of the patients were requested laboratory tests in accordance with the reference criteria (n=27). The estimated cost in unnecessary examinations was $1,129,552 in a year. The results were similar to others related to this theme, however, they had not been revised from the perspective of the first level of attention regarding the importance of adherence to the reference criteria which could prevent major expenditures. It is a priority for leaders and operational consultants in medical units to establish strategies and lines of action that ensure compliance with institutional policies so as to contain spending on comprehensive services, and which in turn can improve the medical care. Copyright © 2015 Academia Mexicana de Cirugía A.C. Published by Masson Doyma México S.A. All rights reserved.

Reasons for Ineligibility in Phase 1 and 2A HIV Vaccine Clinical Trials at Kenya Aids Vaccine Initiative (KAVI), Kenya

PubMed Central

Omosa-Manyonyi, Gloria S.; Jaoko, Walter; Anzala, Omu; Ogutu, Hilda; Wakasiaka, Sabina; Malogo, Roselyn; Nyange, Jacqueline; Njuguna, Pamela; Ndinya-Achola, Jeckoniah; Bhatt, Kirana; Farah, Bashir; Oyaro, Micah; Schmidt, Claudia; Priddy, Frances; Fast, Patricia

2011-01-01

Background With the persistent challenges towards controlling the HIV epidemic, there is an ongoing need for research into HIV vaccines and drugs. Sub-Saharan African countries - worst affected by the HIV pandemic - have participated in the conduct of clinical trials for HIV vaccines. In Kenya, the Kenya AIDS Vaccine Initiative (KAVI) at the University of Nairobi has conducted HIV vaccine clinical trials since 2001. Methodology Participants were recruited after an extensive informed consent process followed by screening to determine eligibility. Screening included an assessment of risk behavior, medical history and physical examination, and if clinically healthy, laboratory testing. In the absence of locally derived laboratory reference ranges, the ranges used in these trials were derived from populations in the West. Principal findings Two hundred eighty-one participants were screened between 2003 and 2006 for two clinical trials. Of these, 167 (59.4%) met the inclusion/exclusion criteria. Overall, laboratory abnormalities based on the non-indigenous laboratory references used were the most frequent reasons (61.4%) for ineligibility. Medical abnormalities contributed 30.7% of the total reasons for ineligibility. Based on the laboratory reference intervals now developed from East and Southern Africa, those ineligible due to laboratory abnormalities would have been 46.3%. Of the eligible participants, 18.6% declined enrolment. Conclusions Participant recruitment for HIV vaccine clinical trials is a rigorous and time-consuming exercise. Over 61% of the screening exclusions in clinically healthy people were due to laboratory abnormalities. It is essential that laboratory reference ranges generated from local populations for laboratory values be used in the conduct of clinical trials to avoid unnecessary exclusion of willing participants and to avoid over-reporting of adverse events for enrolled participants. Trial registration Protocol IAVI VRC V001 [1]. ClinicalTrials.gov NCT00124007 Protocol IAVI 010 [2] (registration with ClincalTrials.gov is in progress) Protocols IAVI 002 and IAVI 004 are Phase 1 trials only mentioned in introductory paragraphs; details will not be reported. Registration was not required when they were conducted. PMID:21283743

How do laboratory technicians perceive their role in the tuberculosis diagnostic process? A cross-sectional study among laboratory technicians in health centers of Central Java Province, Indonesia.

PubMed

Widjanarko, Bagoes; Widyastari, Dyah Anantalia; Martini, Martini; Ginandjar, Praba

2016-01-01

Detection of acid-fast bacilli in respiratory specimens serves as an initial pulmonary tuberculosis (TB) diagnosis. Laboratories are the essential and fundamental part of all health systems. This study aimed to describe how laboratory technicians perceived their own self and work. This included perceived self-efficacy, perceived role, perceived equipment availability, perceived procedures, perceived reward and job, and perceived benefit of health education, as well as level of knowledge and attitudes related to work performance of laboratory technicians. This was a cross-sectional quantitative study involving 120 laboratory technicians conducted in Central Java. Interviews and observation were conducted to measure performance and work-related variables. Among 120 laboratory technicians, 43.3% showed fairly good performance. They complied with 50%-75% of all procedures, including sputum collection, laboratory tools utilization, sputum smearing, staining, smear examination, grading of results, and universal precaution practice. Perceived role, perceived self-efficacy, and knowledge of laboratory procedures were significantly correlated to performance, besides education and years of working as a laboratory technician. Perceived equipment availability was also significantly correlated to performance after the education variable was controlled. Most of the laboratory technicians believed that they have an important role in TB patients' treatment and should display proper self-efficacy in performing laboratory activities. The result may serve as a basic consideration to develop a policy for enhancing motivation of laboratory technicians in order to improve the TB control program.

78 FR 77019 - Energy Conservation Program: Energy Conservation Standards for Certain Consumer Products

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-20

... Regulations the definitions for ``through-the-wall central air conditioner'' and ``through-the-wall central... superseded effective in 2006, and the now defunct references to the ``through-the-wall air conditioner and... definitions for ``through-the-wall central air conditioner'' and ``through-the-wall central air conditioning...

Catalog of Federal metrology and calibration capabilities: 1980 edition

NASA Astrophysics Data System (ADS)

Leedy, K. O.

1980-09-01

Federal laboratories involved in metrology and calibration are listed. Included is the name of a person to contact at each laboratory telephone number and address. The capabilities of each laboratory are indicated in a tabular listing by agency. To provide geographical distribution, the laboratories are listed by States. In addition, the laboratories are shown on a map by coded number. Other references are described.

19. VIEW OF THE GENERAL CHEMISTRY LABORATORY IN BUILDING 881. ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

19. VIEW OF THE GENERAL CHEMISTRY LABORATORY IN BUILDING 881. (4/12/62) - Rocky Flats Plant, General Manufacturing, Support, Records-Central Computing, Southern portion of Plant, Golden, Jefferson County, CO

Profile of central research and application laboratory of Aǧrı İbrahim Çeçen University

NASA Astrophysics Data System (ADS)

Türkoǧlu, Emir Alper; Kurt, Murat; Tabay, Dilruba

2016-04-01

Aǧrı İbrahim Çeçen University built a central research and application laboratory (CRAL) in the east of Turkey. The CRAL possesses 7 research and analysis laboratories, 12 experts and researchers, 8 standard rooms for guest researchers, a restaurant, a conference hall, a meeting room, a prey room and a computer laboratory. The CRAL aims certain collaborations between researchers, experts, clinicians and educators in the areas of biotechnology, bioimagining, food safety & quality, omic sciences such as genomics, proteomics and metallomics. It also intends to develop sustainable solutions in agriculture and animal husbandry, promote public health quality, collect scientific knowledge and keep it for future generations, contribute scientific awareness of all stratums of society, provide consulting for small initiatives and industries. It has been collaborated several scientific foundations since 2011.

Hematology and Plasma Chemistry Reference Intervals for Mature Laboratory Pine Voles (Microtus pinetorum) as Determined by Using the Nonparametric Rank Percentile Method

PubMed Central

Harvey, Stephen B; Krimer, Paula M; Correa, Maria T; Hanes, Martha A

2008-01-01

Plasma biochemical and hematologic values are important parameters for assessing animal health and experimental results. Although normal reference values for many rodent species have been published, there is a dearth of similar information for the genus Microtus. In addition, most studies use a mean and standard deviation to establish reference intervals, but doing so is not the recommendation of the Clinical and Laboratory Standards Institute (formerly the National Committee on Clinical Laboratory Standards) or the International Federation of Clinical Chemistry and Laboratory Medicine. The purpose of this study was to establish normal reference parameters for plasma biochemistry and hematology in mature pine voles (Microtus pinetorum) by using the nonparametric rank percentile method as recommended by the 2 laboratory medicine organizations mentioned. Samples of cardiac blood from a closed colony of pine voles were collected at euthanasia and evaluated under rodent settings on 2 automated hematology analyzers from 2 different manufacturers and on the same type of automated biochemistry analyzer. There were no sex-associated clinically significant differences between the sexes; younger animals had a lower hematocrit, higher mean corpuscular volume, and lower mean corpuscular hemoglobin concentration than did older animals. Only platelet counts differed when comparing hematologic values from different analyzers. Relative to rats and mice, pine voles have a lower mean corpuscular volume and higher red blood cell count, higher blood urea nitrogen, much higher alanine aminotransferase, and lower glucose and phosphorous concentrations. Hematology and plasma biochemical results obtained in this study are considered representative for healthy adult laboratory pine voles under similar environmental conditions. PMID:18702449

Proceedings of the Flat-Plate Solar Array Project Research Forum on the Design of Flat-Plate Photovoltaic Arrays for Central Stations

NASA Technical Reports Server (NTRS)

1983-01-01

The Flat Plate Solar Array Project, focuses on advancing technologies relevant to the design and construction of megawatt level central station systems. Photovoltaic modules and arrays for flat plate central station or other large scale electric power production facilities require the establishment of a technical base that resolves design issues and results in practical and cost effective configurations. Design, qualification and maintenance issues related to central station arrays derived from the engineering and operating experiences of early applications and parallel laboratory reserch activities are investigated. Technical issues are examined from the viewpoint of the utility engineer, architect/engineer and laboratory researcher. Topics on optimum source circuit designs, module insulation design for high system voltages, array safety, structural interface design, measurements, and array operation and maintenance are discussed.

A review of international biobanks and networks: success factors and key benchmarks.

PubMed

Vaught, Jim; Kelly, Andrea; Hewitt, Robert

2009-09-01

Biobanks and biobanking networks are involved in varying degrees in the collection, processing, storage, and dissemination of biological specimens. This review outlines the approaches that 16 of the largest biobanks and biobanking networks in Europe, North America, Australia, and Asia have taken to collecting and distributing human research specimens and managing scientific initiatives while covering operating costs. Many are small operations that exist as either a single or a few freezers in a research laboratory, hospital clinical laboratory, or pathology suite. Larger academic and commercial biobanks operate to support large clinical and epidemiological studies. Operational and business models depend on the medical and research missions of their institutions and home countries. Some national biobanks operate with a centralized physical biobank that accepts samples from multiple locations. Others operate under a "federated" model where each institution maintains its own collections but agrees to list them on a central shared database. Some collections are "project-driven" meaning that specimens are collected and distributed to answer specific research questions. "General" collections are those that exist to establish a reference collection, that is, not to meet particular research goals but to be available to respond to multiple requests for an assortment of research uses. These individual and networked biobanking systems operate under a variety of business models, usually incorporating some form of partial cost recovery, while requiring at least partial public or government funding. Each has a well-defined biospecimen-access policy in place that specifies requirements that must be met-such as ethical clearance and the expertise to perform the proposed experiments-to obtain samples for research. The success of all of these biobanking models depends on a variety of factors including well-defined goals, a solid business plan, and specimen collections that are developed according to strict quality and operational controls.

Human herpesvirus infections of the central nervous system: laboratory diagnosis based on DNA detection by nested PCR in plasma and cerebrospinal fluid samples.

PubMed

Rimério, Carla Aparecida Tavares; De Oliveira, Renato Souza; de Almeida Bonatelli, Murilo Queiroz; Nucci, Anamarli; Costa, Sandra Cecília Botelho; Bonon, Sandra Helena Alves

2015-04-01

Infections of the central nervous systems (CNS) present a diagnostic problem for which an accurate laboratory diagnosis is essential. Invasive practices, such as cerebral biopsy, have been replaced by obtaining a polymerase chain reaction (PCR) diagnosis using cerebral spinal fluid (CSF) as a reference method. Tests on DNA extracted from plasma are noninvasive, thus avoiding all of the collateral effects and patient risks associated with CSF collection. This study aimed to determine whether plasma can replace CSF in nested PCR analysis for the detection of CNS human herpesvirus (HHV) diseases by analysing the proportion of patients whose CSF nested PCR results were positive for CNS HHV who also had the same organism identified by plasma nested PCR. In this study, CSF DNA was used as the "gold standard," and nested PCR was performed on both types of samples. Fifty-two patients with symptoms of nervous system infection were submitted to CSF and blood collection. For the eight HHV, one positive DNA result-in plasma and/or CSF nested PCR-was considered an active HHV infection, whereas the occurrence of two or more HHVs in the same sample was considered a coinfection. HHV infections were positively detected in 27/52 (51.9%) of the CSF and in 32/52 (61.5%) of the plasma, difference not significant, thus nested PCR can be performed on plasma instead of CSF. In conclusion, this findings suggest that plasma as a useful material for the diagnosis of cases where there is any difficulty to perform a CSF puncture. © 2015 Wiley Periodicals, Inc.

Neurocognitive performance and physical function do not change with physical-cognitive-mindfulness training in female laboratory technicians with chronic musculoskeletal pain

PubMed Central

Jay, Kenneth; Brandt, Mikkel; Schraefel, mc; Jakobsen, Markus Due; Sundstrup, Emil; Sjøgaard, Gisela; Vinstrup, Jonas; Andersen, Lars L.

2016-01-01

Abstract Background: Cognitive and physical performance can be negatively affected by chronic pain. This study evaluates the effect of combined physical-, cognitive-, and mindfulness training (PCMT) on cognitive and physical performance. Methods: From a large pharmaceutical company in Denmark we randomly allocated 112 female laboratory technicians with chronic upper limb pain to group-based PCMT at the worksite or a reference group for 10 weeks. Neurocognitive performance was measured by the computerized central nervous system vital signs neurocognitive assessment battery. Physical function was assessed in terms of shoulder external rotation strength and rate of force development in a custom-made dynamometer setup. Results: No between-group differences (least square means [95% confidence interval]) from baseline to follow-up could be detected in any of the neurocognitive domains as measured by the central nervous system vital signs neurocognitive assessment battery, for example, Psychomotoer Speed 1.9 (−1.0 to 4.7), Reaction Time −4.0 (−19.5 to 11.6), Complex Attention −0.3 (−1.9 to 1.4), and Executive Function −0.2 (−3.5 to 3.0). Similarly, we found no change in maximal voluntary isometric strength −0.63 (−4.8 to 3.6), or rate of force development 14.8 (−12.6 to 42.2) of the shoulder external rotators. Finally, test–retest reliability of maximal voluntary contraction and rate of force development shoulder external rotation showed high reliability at 0 to 30 ms, 0 to 50 ms, 0 to 100 ms, and 0 to 200 ms with ICCs at 0.95, 0.92, 0.93, 0.92, and 0.91, respectively. Conclusion: Ten weeks of PCMT did not improve neurocognitive or physical performance. PMID:27977585

The Laboratory. Guides for the Improvement of Instruction in Higher Education, No. 9.

ERIC Educational Resources Information Center

Alexander, Lawrence T.; And Others

This guide for the improvement of instruction in higher education is designed to aid the educator in planning and conducting laboratory instruction. The examples used refer primarily to science laboratories. Topics discussed include: deciding whether or not to use the laboratory method (with a discussion of discovery learning or the processes of…

Pilot-Scale Laboratory Instruction for Chemical Engineering: The Specific Case of the Pilot-Unit Leading Group

ERIC Educational Resources Information Center

Billet, Anne-Marie; Camy, Severine; Coufort-Saudejaud, Carole

2010-01-01

This paper presents an original approach for Chemical Engineering laboratory teaching that is currently applied at INP-ENSIACET (France). This approach, referred to as "pilot-unit leading group" is based on a partial management of the laboratories by the students themselves who become temporarily in charge of one specific laboratory. In…

[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.

New Brunswick Laboratory: Progress report, October 1993 through September 1994

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

NONE

The mission of the New Brunswick Laboratory of the US Department of Energy (DOE) is to serve as the National Certifying Authority for nuclear reference materials and to provide an independent Federal technical staff and laboratory resource performing nuclear material measurement, safeguards and non-proliferation functions in support of multiple program sponsors. During FY 94 New Brunswick Laboratory (NBL) completed development of a Strategic Plan which will aid in better defining performance oriented laboratory goals and objectives in each functional area consistent with the changing needs of the global nuclear community. This annual report describes accomplishments achieved in carrying out NBL`smore » assigned missions. Details of completed projects are reported in separate topical reports or as open-literature publications. Programs discussed here are: (1) safeguards assistance; (2) reference materials program; (3) measurement evaluation; (4) measurement services; and (5) measurement development.« less

New Ca-Tims and La-Icp Analyses of GJ-1, Plesovice, and FC1 Reference Materials

NASA Astrophysics Data System (ADS)

Feldman, J. D.; Möller, A.; Walker, J. D.

2014-12-01

Laser ablation inductively coupled plasma mass spectrometry (LA-ICP-MS) U-Pb zircon geochronology relies on external reference standards to monitor and correct for different mass fractionation effects and instrument drift. Common zircon reference materials used within the community, including the KU Isotope Geochemistry Laboratory, are GJ-1 (207Pb/206Pb age: 608.53 +/- 0.37Ma; Jackson et al., 2004), Plesovice (337.13 +/- 0.37 Ma; Slama et al., 2008), and FC-1 (1099.0 +/-0.6 Ma; Paces and Miller, 1993). The age distribution of zircon reference material varies slightly from sample fraction to sample fraction, and the published results for GJ-1 are slightly discordant. As a result, using the published data for the distributed standard splits can lead to small systematic variations when comparing datasets from different labs, and more high precision data are needed to evaluate potential inhomogeneity of sample splits used in different laboratories. Here we characterize these reference materials with cathodoluminescence, LA-ICP-MS traverses across grains, and high precision CA-TIMS to better constrain the ages and assess zoning of these standards, and present the data for comparison with other laboratories. Reducing systematic error by dating our own reference material lends confidence to our analyses and allows for inter-laboratory age reproducibility of unknowns. Additionally, the reduction in propagated uncertainties (especially in GJ-1, for which both the red and yellow variety will be analyzed) will be used to improve long-term reproducibility, comparisons between samples of similar age, detrital populations and composite pluton zircons. Jackson, S.E., et al., 2004, Chemical Geology, v. 211, p. 47-69. Paces, J.B. & Miller, J.D., 1993, Journal of Geophysical Research, v. 80, p. 13997-14013. Slama, J., et al., 2008, Chemical Geology, v. 249. p. 1-35.

Dental Laboratory Technology.

ERIC Educational Resources Information Center

Department of the Air Force, Washington, DC.

The Air Force dental laboratory technology manual is designed as a basic training text as well as a reference source for dental laboratory technicians, a specialty occupation concerned with the design, fabrication, and repair of dental prostheses. Numerous instructive diagrams and photographs are included throughout the manual. The comprehensive…

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.

The Second National Ballistics Imaging Comparison (NBIC-2)

PubMed Central

Vorburger, TV; Yen, J; Song, JF; Thompson, RM; Renegar, TB; Zheng, A; Tong, M; Ols, M

2014-01-01

In response to the guidelines issued by the American Society of Crime Laboratory Directors/Laboratory Accreditation Board (ASCLD/LAB-International) to establish traceability and quality assurance in U.S. crime laboratories, NIST and the ATF initiated a joint project, entitled the National Ballistics Imaging Comparison (NBIC). The NBIC project aims to establish a national traceability and quality system for ballistics identifications in crime laboratories utilizing ATF’s National Integrated Ballistics Information Network (NIBIN). The original NBIC was completed in 2010. In the second NBIC, NIST Standard Reference Material (SRM) 2461 Cartridge Cases were used as reference standards, and 14 experts from 11 U.S. crime laboratories each performed 17 image acquisitions and correlations of the SRM cartridge cases over the course of about half a year. Resulting correlation scores were collected by NIST for statistical analyses, from which control charts and control limits were developed for the proposed quality system and for promoting future assessments and accreditations for firearm evidence in U.S. forensic laboratories in accordance with the ISO 17025 Standard. PMID:26601051

The Second National Ballistics Imaging Comparison (NBIC-2).

PubMed

Vorburger, T V; Yen, J; Song, J F; Thompson, R M; Renegar, T B; Zheng, A; Tong, M; Ols, M

2014-01-01

In response to the guidelines issued by the American Society of Crime Laboratory Directors/Laboratory Accreditation Board (ASCLD/LAB-International) to establish traceability and quality assurance in U.S. crime laboratories, NIST and the ATF initiated a joint project, entitled the National Ballistics Imaging Comparison (NBIC). The NBIC project aims to establish a national traceability and quality system for ballistics identifications in crime laboratories utilizing ATF's National Integrated Ballistics Information Network (NIBIN). The original NBIC was completed in 2010. In the second NBIC, NIST Standard Reference Material (SRM) 2461 Cartridge Cases were used as reference standards, and 14 experts from 11 U.S. crime laboratories each performed 17 image acquisitions and correlations of the SRM cartridge cases over the course of about half a year. Resulting correlation scores were collected by NIST for statistical analyses, from which control charts and control limits were developed for the proposed quality system and for promoting future assessments and accreditations for firearm evidence in U.S. forensic laboratories in accordance with the ISO 17025 Standard.

Classification of neural tumors in laboratory rodents, emphasizing the rat.

PubMed

Weber, Klaus; Garman, Robert H; Germann, Paul-Georg; Hardisty, Jerry F; Krinke, Georg; Millar, Peter; Pardo, Ingrid D

2011-01-01

Neoplasms of the nervous system, whether spontaneous or induced, are infrequent in laboratory rodents and very rare in other laboratory animal species. The morphology of neural tumors depends on the intrinsic functions and properties of the cell type, the interactions between the neoplasm and surrounding normal tissue, and regressive changes. The incidence of neural neoplasms varies with sex, location, and age of tumor onset. Although the onset of spontaneous tumor development cannot be established in routine oncogenicity studies, calculations using the time of diagnosis (day of death) have revealed significant differences in tumor biology among different rat strains. In the central nervous system, granular cell tumors (a meningioma variant), followed by glial tumors, are the most common neoplasms in rats, whereas glial cell tumors are observed most frequently in mice. Central nervous system tumors usually affect the brain rather than the spinal cord. Other than adrenal gland pheochromocytomas, the most common neoplasms of the peripheral nervous system are schwannomas. Neural tumors may develop in the central nervous system and peripheral nervous system from other cell lineages (including extraneural elements like adipose tissue and lymphocytes), but such lesions are very rare in laboratory animals.

A Low Cost Microcomputer Laboratory for Investigating Computer Architecture.

ERIC Educational Resources Information Center

Mitchell, Eugene E., Ed.

1980-01-01

Described is a microcomputer laboratory at the United States Military Academy at West Point, New York, which provides easy access to non-volatile memory and a single input/output file system for 16 microcomputer laboratory positions. A microcomputer network that has a centralized data base is implemented using the concepts of computer network…

Human friendly architectural design for a small Martian base

NASA Astrophysics Data System (ADS)

Kozicki, J.; Kozicka, J.

2011-12-01

The manned mission to Mars is expected to last almost three years. A human factor must be taken seriously into account in such a long-term mission. A big comfortable habitat can help to overcome sociopsychological problems, that occur in ICEs (Isolated and Confined Environments). Authors have come forward to this issue and have developed a Martian base design as a human friendly habitat. The project is based on researches of extreme conditions on Mars, architecture in ICEs and contemporary building technologies. The base consists of five modules: a Central Module (CM), an Agriculture Dome (AD), a Residential Dome (RD), a Laboratory Dome (LD) and a Garage (G). Each element has its own functional purpose. The CM is a metal capsule similar to the Reference Mission module (RM, NASA, 1997). Domes are inflatable multilayer structures, which interiors are "open planned". Interiors can be arranged and divided into rooms by using modular partition walls designed by authors.

Summary report of mission acceleration measurements for Spacehab-01, STS-57 launched 21 June 1993

NASA Technical Reports Server (NTRS)

Finley, Brian; Grodsinsky, Carlos; Delombard, Richard

1994-01-01

The maiden voyage of the commercial Spacehab laboratory module onboard the STS-57 mission was integrated with several accelerometer packages, one of which was the Space Acceleration Measurement System (SAMS). The June 21st 1993, launch was the seventh successful mission for the Office of Life and Microgravity Sciences and Application's (OLMSA) SAMS unit. This flight was also complemented by a second accelerometer system. The Three Dimensional Microgravity Accelerometer (3-DMA), a Code C funded acceleration measurement system, offering an on-orbit residual calibration as a reference for the unit's four triaxial accelerometers. The SAMS accelerometer unit utilized three remote triaxial sensor heads mounted on the forward Spacehab module bulkhead and on one centrally located experiment locker door. These triaxial heads had filter cut-offs set to 5, 50, and 1000 Hz. The mission also included other experiment specific accelerometer packages in various locations.

Aquatic effects assessment: needs and tools.

PubMed

Marchini, Silvia

2002-01-01

In the assessment of the adverse effects pollutants can produce on exposed ecosystems, different approaches can be followed depending on the quality and quantity of information available, whose advantages and limits are discussed with reference to the aquatic compartment. When experimental data are lacking, a predictive approach can be pursued by making use of validated quantitative structure-activity relationships (QSARs), which provide reliable ecotoxicity estimates only if appropriate models are applied. The experimental approach is central to any environmental hazard assessment procedure, although many uncertainties underlying the extrapolation from a limited set of single species laboratory data to the complexity of the ecosystem (e.g., the limitations of common summary statistics, the variability of species sensitivity, the need to consider alterations at higher level of integration) make the task difficult. When adequate toxicity information are available, the statistical extrapolation approach can be used to predict environmental compatible concentrations.

Effects of laboratory housing on exploratory behaviour, novelty discrimination and spatial reference memory in a subterranean, solitary rodent, the Cape mole-rat (Georychus capensis).

PubMed

Oosthuizen, Maria Kathleen; Scheibler, Anne-Gita; Bennett, Nigel Charles; Amrein, Irmgard

2013-01-01

A large number of laboratory and field based studies are being carried out on mole-rats, both in our research group and others. Several studies have highlighted the development of adverse behaviours in laboratory animals and have emphasised the importance of enrichment for captive animals. Hence we were interested in evaluating how laboratory housing would affect behavioural performance in mole-rats. We investigated exploratory behaviour, the ability to discriminate between novel and familiar environments and reference memory in the solitary Cape mole-rat (Georychus capensis). Our data showed that both wild and captive animals readily explore open spaces and tunnels. Wild animals were however more active than their captive counterparts. In the Y maze two trial discrimination task, wild animals failed to discriminate between novel and familiar environments, while laboratory housed mole-rats showed preferential spatial discrimination in terms of the length of time spent in the novel arm. The performance of the laboratory and wild animals were similar when tested for reference memory in the Y maze, both groups showed a significant improvement compared to the first day, from the 3rd day onwards. Wild animals made more mistakes whereas laboratory animals were slower in completing the task. The difference in performance between wild and laboratory animals in the Y-maze may be as a result of the lower activity of the laboratory animals. Laboratory maintained Cape mole-rats show classic behaviours resulting from a lack of stimulation such as reduced activity and increased aggression. However, they do display an improved novelty discrimination compared to the wild animals. Slower locomotion rate of the laboratory animals may increase the integration time of stimuli, hence result in a more thorough inspection of the surroundings. Unlike the captive animals, wild animals show flexibility in their responses to unpredictable events, which is an important requirement under natural living conditions.

Effects of Laboratory Housing on Exploratory Behaviour, Novelty Discrimination and Spatial Reference Memory in a Subterranean, Solitary Rodent, the Cape Mole-Rat (Georychus capensis)

PubMed Central

Oosthuizen, Maria Kathleen; Scheibler, Anne-Gita; Charles Bennett, Nigel; Amrein, Irmgard

2013-01-01

A large number of laboratory and field based studies are being carried out on mole-rats, both in our research group and others. Several studies have highlighted the development of adverse behaviours in laboratory animals and have emphasised the importance of enrichment for captive animals. Hence we were interested in evaluating how laboratory housing would affect behavioural performance in mole-rats. We investigated exploratory behaviour, the ability to discriminate between novel and familiar environments and reference memory in the solitary Cape mole-rat ( Georychus capensis ). Our data showed that both wild and captive animals readily explore open spaces and tunnels. Wild animals were however more active than their captive counterparts. In the Y maze two trial discrimination task, wild animals failed to discriminate between novel and familiar environments, while laboratory housed mole-rats showed preferential spatial discrimination in terms of the length of time spent in the novel arm. The performance of the laboratory and wild animals were similar when tested for reference memory in the Y maze, both groups showed a significant improvement compared to the first day, from the 3rd day onwards. Wild animals made more mistakes whereas laboratory animals were slower in completing the task. The difference in performance between wild and laboratory animals in the Y-maze may be as a result of the lower activity of the laboratory animals. Laboratory maintained Cape mole-rats show classic behaviours resulting from a lack of stimulation such as reduced activity and increased aggression. However, they do display an improved novelty discrimination compared to the wild animals. Slower locomotion rate of the laboratory animals may increase the integration time of stimuli, hence result in a more thorough inspection of the surroundings. Unlike the captive animals, wild animals show flexibility in their responses to unpredictable events, which is an important requirement under natural living conditions. PMID:24040422

Validation of reference materials for uranium radiochronometry in the frame of nuclear forensic investigations

DOE PAGES

Varga, Z.; Mayer, K.; Bonamici, C. E.; ...

2015-05-11

The results of a joint effort by expert nuclear forensic laboratories in the area of age dating of uranium, i.e. the elapsed time since the last chemical purification of the material are presented and discussed. Completely separated uranium materials of known production date were distributed among the laboratories, and the samples were dated according to routine laboratory procedures by the measurement of the ²²⁰Th/²³⁴U ratio. The measurement results were in good agreement with the known production date showing that the concept for preparing uranium age dating reference material based on complete separation is valid. Detailed knowledge of the laboratory proceduresmore » used for uranium age dating allows the identification of possible improvements in the current protocols and the development of improved practice in the future. The availability of age dating reference materials as well as the evolvement of the age dating best-practice protocol will increase the relevance and applicability of age dating as part of the tool-kit available for nuclear forensic investigations.« less

Validation of reference materials for uranium radiochronometry in the frame of nuclear forensic investigations

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

Varga, Z.; Mayer, K.; Bonamici, C. E.

The results of a joint effort by expert nuclear forensic laboratories in the area of age dating of uranium, i.e. the elapsed time since the last chemical purification of the material are presented and discussed. Completely separated uranium materials of known production date were distributed among the laboratories, and the samples were dated according to routine laboratory procedures by the measurement of the ²²⁰Th/²³⁴U ratio. The measurement results were in good agreement with the known production date showing that the concept for preparing uranium age dating reference material based on complete separation is valid. Detailed knowledge of the laboratory proceduresmore » used for uranium age dating allows the identification of possible improvements in the current protocols and the development of improved practice in the future. The availability of age dating reference materials as well as the evolvement of the age dating best-practice protocol will increase the relevance and applicability of age dating as part of the tool-kit available for nuclear forensic investigations.« less

21 CFR 660.25 - Potency tests without reference preparations.

Code of Federal Regulations, 2012 CFR

2012-04-01

... manufacturer's package insert using red blood cells showing heterozygous or diminished expression of the... SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.25 Potency tests without reference preparations. Products for which Reference Blood...

21 CFR 660.25 - Potency tests without reference preparations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... manufacturer's package insert using red blood cells showing heterozygous or diminished expression of the... SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.25 Potency tests without reference preparations. Products for which Reference Blood...

21 CFR 660.25 - Potency tests without reference preparations.

Code of Federal Regulations, 2014 CFR

2014-04-01

... manufacturer's package insert using red blood cells showing heterozygous or diminished expression of the... SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.25 Potency tests without reference preparations. Products for which Reference Blood...

21 CFR 660.25 - Potency tests without reference preparations.

Code of Federal Regulations, 2011 CFR

2011-04-01

... manufacturer's package insert using red blood cells showing heterozygous or diminished expression of the... SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.25 Potency tests without reference preparations. Products for which Reference Blood...

21 CFR 660.25 - Potency tests without reference preparations.

Code of Federal Regulations, 2013 CFR

2013-04-01

... manufacturer's package insert using red blood cells showing heterozygous or diminished expression of the... SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.25 Potency tests without reference preparations. Products for which Reference Blood...

From High-Throughput Microarray-Based Screening to Clinical Application: The Development of a Second Generation Multigene Test for Breast Cancer Prognosis

PubMed Central

Brase, Jan C.; Kronenwett, Ralf; Petry, Christoph; Denkert, Carsten; Schmidt, Marcus

2013-01-01

Several multigene tests have been developed for breast cancer patients to predict the individual risk of recurrence. Most of the first generation tests rely on proliferation-associated genes and are commonly carried out in central reference laboratories. Here, we describe the development of a second generation multigene assay, the EndoPredict test, a prognostic multigene expression test for estrogen receptor (ER) positive, human epidermal growth factor receptor (HER2) negative (ER+/HER2−) breast cancer patients. The EndoPredict gene signature was initially established in a large high-throughput microarray-based screening study. The key steps for biomarker identification are discussed in detail, in comparison to the establishment of other multigene signatures. After biomarker selection, genes and algorithms were transferred to a diagnostic platform (reverse transcription quantitative PCR (RT-qPCR)) to allow for assaying formalin-fixed, paraffin-embedded (FFPE) samples. A comprehensive analytical validation was performed and a prospective proficiency testing study with seven pathological laboratories finally proved that EndoPredict can be reliably used in the decentralized setting. Three independent large clinical validation studies (n = 2,257) demonstrated that EndoPredict offers independent prognostic information beyond current clinicopathological parameters and clinical guidelines. The review article summarizes several important steps that should be considered for the development process of a second generation multigene test and offers a means for transferring a microarray signature from the research laboratory to clinical practice. PMID:27605191

Drug resistance of Mycobacterium tuberculosis in Malawi: a cross-sectional survey

PubMed Central

Abouyannis, Michael; Dacombe, Russell; Dambe, Isaias; Mpunga, James; Faragher, Brian; Gausi, Francis; Ndhlovu, Henry; Kachiza, Chifundo; Suarez, Pedro; Mundy, Catherine; Banda, Hastings T; Nyasulu, Ishmael

2014-01-01

Abstract Objective To document the prevalence of multidrug resistance among people newly diagnosed with – and those retreated for – tuberculosis in Malawi. Methods We conducted a nationally representative survey of people with sputum-smear-positive tuberculosis between 2010 and 2011. For all consenting participants, we collected demographic and clinical data, two sputum samples and tested for human immunodeficiency virus (HIV).The samples underwent resistance testing at the Central Reference Laboratory in Lilongwe, Malawi. All Mycobacterium tuberculosis isolates found to be multidrug-resistant were retested for resistance to first-line drugs – and tested for resistance to second-line drugs – at a Supranational Tuberculosis Reference Laboratory in South Africa. Findings Overall, M. tuberculosis was isolated from 1777 (83.8%) of the 2120 smear-positive tuberculosis patients. Multidrug resistance was identified in five (0.4%) of 1196 isolates from new cases and 28 (4.8%) of 581 isolates from people undergoing retreatment. Of the 31 isolates from retreatment cases who had previously failed treatment, nine (29.0%) showed multidrug resistance. Although resistance to second-line drugs was found, no cases of extensive drug-resistant tuberculosis were detected. HIV testing of people from whom M. tuberculosis isolates were obtained showed that 577 (48.2%) of people newly diagnosed and 386 (66.4%) of people undergoing retreatment were positive. Conclusion The prevalence of multidrug resistance among people with smear-positive tuberculosis was low for sub-Saharan Africa – probably reflecting the strength of Malawi’s tuberculosis control programme. The relatively high prevalence of such resistance observed among those with previous treatment failure may highlight a need for a change in the national policy for retreating this subgroup of people with tuberculosis. PMID:25378741

European multicentre validation study of the accuracy of E/e' ratio in estimating invasive left ventricular filling pressure: EURO-FILLING study.

PubMed

Galderisi, Maurizio; Lancellotti, Patrizio; Donal, Erwan; Cardim, Nuno; Edvardsen, Thor; Habib, Gilbert; Magne, Julien; Maurer, Gerald; Popescu, Bogdan A

2014-07-01

The non-invasive estimation of left ventricular filling pressures (LVFPs) represents a main goal in the clinical setting. Current recommendations encourage the use of pulsed-wave Tissue Doppler for calculating the ratio between the preload-dependent transmitral E velocity and the average of septal and lateral early diastolic velocities (e') of the mitral annulus. Despite its wide use, real utility of the E/e' ratio has been recently challenged in patients with either very advanced heart failure or preserved left ventricular (LV) ejection fraction. However, only few studies performed the invasive and non-invasive estimation of LVFP simultaneously. The EURO-FILLING Study will validate the E/e' ratio (and additional non-invasive estimates) against simultaneously measured LVFP obtained by left heart catheterization in a multicentre study involving reference European echo laboratories collecting a wide population sample size of cardiac patients with and without heart failure. The EURO-FILLING study is a large, prospective observational study in which simultaneous assessment of invasive and non-invasive measurements of LVFP will be acquired in eight reference European centres. Centralized reading of the collected parameters will be performed in a core laboratory. Not only standardized echo Doppler measurements but also novel echo parameters such as LV global longitudinal strain and global atrial strain (obtainable by two-dimensional speckle tracking echocardiography) will be tested for predicting invasive measurements of LVFP. The EURO-FILLING study is expected to provide important information on non-invasive assessment of LVFP and to contribute to the standardization of this assessment in clinical practice. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

Cholera Rapid Test with Enrichment Step Has Diagnostic Performance Equivalent to Culture

PubMed Central

Ontweka, Lameck N.; Deng, Lul O.; Rauzier, Jean; Debes, Amanda K.; Tadesse, Fisseha; Parker, Lucy A.; Wamala, Joseph F.; Bior, Bior K.; Lasuba, Michael; But, Abiem Bona; Grandesso, Francesco; Jamet, Christine; Cohuet, Sandra; Ciglenecki, Iza; Serafini, Micaela; Sack, David A.; Quilici, Marie-Laure; Azman, Andrew S.; Luquero, Francisco J.

2016-01-01

Cholera rapid diagnostic tests (RDT) could play a central role in outbreak detection and surveillance in low-resource settings, but their modest performance has hindered their broad adoption. The addition of an enrichment step may improve test specificity. We describe the results of a prospective diagnostic evaluation of the Crystal VC RDT (Span Diagnostics, India) with enrichment step and of culture, each compared to polymerase chain reaction (PCR), during a cholera outbreak in South Sudan. RDTs were performed on alkaline peptone water inoculated with stool and incubated for 4–6 hours at ambient temperature. Cholera culture was performed from wet filter paper inoculated with stool. Molecular detection of Vibrio cholerae O1 by PCR was done from dry Whatman 903 filter papers inoculated with stool, and from wet filter paper supernatant. In August and September 2015, 101 consecutive suspected cholera cases were enrolled, of which 36 were confirmed by PCR. The enriched RDT had 86.1% (95% CI: 70.5–95.3) sensitivity and 100% (95% CI: 94.4–100) specificity compared to PCR as the reference standard. The sensitivity of culture versus PCR was 83.3% (95% CI: 67.2–93.6) for culture performed on site and 72.2% (95% CI: 54.8–85.8) at the international reference laboratory, where samples were tested after an average delay of two months after sample collection, and specificity was 98.5% (95% CI: 91.7–100) and 100% (95% CI: 94.5–100), respectively. The RDT with enrichment showed performance comparable to that of culture and could be a sustainable alternative to culture confirmation where laboratory capacity is limited. PMID:27992488

Reliability on intra-laboratory and inter-laboratory data of hair mineral analysis comparing with blood analysis.

PubMed

Namkoong, Sun; Hong, Seung Phil; Kim, Myung Hwa; Park, Byung Cheol

2013-02-01

Nowadays, although its clinical value remains controversial institutions utilize hair mineral analysis. Arguments about the reliability of hair mineral analysis persist, and there have been evaluations of commercial laboratories performing hair mineral analysis. The objective of this study was to assess the reliability of intra-laboratory and inter-laboratory data at three commercial laboratories conducting hair mineral analysis, compared to serum mineral analysis. Two divided hair samples taken from near the scalp were submitted for analysis at the same time, to all laboratories, from one healthy volunteer. Each laboratory sent a report consisting of quantitative results and their interpretation of health implications. Differences among intra-laboratory and interlaboratory data were analyzed using SPSS version 12.0 (SPSS Inc., USA). All the laboratories used identical methods for quantitative analysis, and they generated consistent numerical results according to Friedman analysis of variance. However, the normal reference ranges of each laboratory varied. As such, each laboratory interpreted the patient's health differently. On intra-laboratory data, Wilcoxon analysis suggested they generated relatively coherent data, but laboratory B could not in one element, so its reliability was doubtful. In comparison with the blood test, laboratory C generated identical results, but not laboratory A and B. Hair mineral analysis has its limitations, considering the reliability of inter and intra laboratory analysis comparing with blood analysis. As such, clinicians should be cautious when applying hair mineral analysis as an ancillary tool. Each laboratory included in this study requires continuous refinement from now on for inducing standardized normal reference levels.

DOE research and development report. Progress report, October 1980-September 1981

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

Bingham, Carleton D.

The DOE New Brunswick Laboratory (NBL) is the US Government's Nuclear Materials Standards and Measurement Laboratory. NBL is assigned the mission to provide and maintain, as an essential part of federal statutory responsibilities related to national and international safeguards of nuclear materials for USA defense and energy programs, an ongoing capability for: the development, preparation, certification, and distribution of reference materials for the calibration and standardization of nuclear materials measurements; the development, improvement, and evaluation of nuclear materials measurement technology; the assessment and evaluation of the practice and application of nuclear materials measurement technology; expert and reliable specialized nuclear materialsmore » measurement services for the government; and technology exchange and training in nuclear materials measurement and standards. Progress reports for this fiscal year are presented under the following sections: (1) development or evaluation of measurement technology (elemental assay of uranium plutonium; isotope composition); (2) standards and reference materials (NBL standards and reference materials; NBS reference materials); and (3) evaluation programs (safeguards analytical laboratory evaluation; general analytical evaluation program; other evaluation programs).« less

Quantity quotient reporting. A proposal for a standardized presentation of laboratory results.

PubMed

Haeckel, Rainer; Wosniok, Werner

2009-01-01

Laboratory results are reported in different units (despite international recommendations for SI units) together with different reference limits, of which several exist for many quantities. It is proposed to adopt the concept of the intelligence quotient and to report quantitative results as a quantity quotient (QQ) in laboratory medicine. This quotient is essentially the difference (measured result minus mean or mode value of the reference interval) divided by the observed biological variation CV(o). Thus, all quantities are reported in the same unit system with the same reference limits (for convenience shifted to e.g., 80-120). The critical difference can also be included in this standardization concept. In this way the information of reference intervals and the original result are integrated into one combined value, which has the same format for all quantities suited for quotient reporting (QR). The proposal of QR does not interfere with neither the current concepts of traceability, SI units or method standardization. This proposal represents a further step towards harmonization of reporting. It provides simple values which can be interpreted easily by physicians and their patients.

Importance of clinical microbiologists for U.S. healthcare infrastructure.

PubMed

Carvalho, John

2011-01-01

Clinical microbiologists are highly skilled scientists within national hospitals and reference laboratories who diagnose patients with infections by emerging pathogens. Most advanced training for clinical microbiologists occurs at universities, where an individual can receive certification as a "Medical Laboratory Scientist" (MLS). Unfortunately, many MLS programs have closed in the United States and this has caused a shortage of clinical microbiologists at U.S. hospitals and reference laboratories. This paper explores the present crisis in MLS training and its ramifications for the emergence of antibiotic-resistant bacteria, the economics of hospitals, and the overall health of the nation, and provides resolutions for better public health policy with respect to MLS education.

[Comparison of serological procedures used for the diagnosis of viral exanthema in laboratories participating in the measles elimination plan].

PubMed

de Ory, Fernando; Sanz, Juan Carlos; Echevarría, Juan Emilio; Mosquera, María del Mar; Guisasola, María Eulalia

2004-01-01

The comparison of serological methods used by the laboratories participating in the Network for the Elimination of Measles to diagnose measles virus infection as well as differential diagnosis with other exanthematic diseases are compared. One panel of 20 serum samples including measles (12), rubella (4), parvovirus B19 (2) and dengue (2) infections was established. All cases were diagnosed by detection of specific IgM. The panel was sent to the laboratories of the Network. The results were compared with those obtained at the reference laboratory. Regarding measles, IgM response from 20 laboratories (19 by ELISA and 1 by indirect immunofluorescence) was obtained, with an agreement of 91.5%. Related to rubella IgM, replay from 6 laboratories, using ELISA, was received, with an agreement of 98.7%. With respect to parvovirus B19 IgM, response from 10 laboratories (8 by ELISA and 2 by indirect immunofluorescence) was obtained, with an agreement of 94.6%. Results about dengue virus were not reported by any laboratory. Some laboratories from the network should review the methods used for the diagnosis of measles and other exanthematic diseases. The results reassert the need for a reference laboratory to support confirmation of the results.

Photovoltaic Calibrations at the National Renewable Energy Laboratory and Uncertainty Analysis Following the ISO 17025 Guidelines

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

Emery, Keith

The measurement of photovoltaic (PV) performance with respect to reference conditions requires measuring current versus voltage for a given tabular reference spectrum, junction temperature, and total irradiance. This report presents the procedures implemented by the PV Cell and Module Performance Characterization Group at the National Renewable Energy Laboratory (NREL) to achieve the lowest practical uncertainty. A rigorous uncertainty analysis of these procedures is presented, which follows the International Organization for Standardization (ISO) Guide to the Expression of Uncertainty in Measurement. This uncertainty analysis is required for the team’s laboratory accreditation under ISO standard 17025, “General Requirements for the Competence ofmore » Testing and Calibration Laboratories.” The report also discusses additional areas where the uncertainty can be reduced.« less

An International Ki67 Reproducibility Study

PubMed Central

2013-01-01

Background In breast cancer, immunohistochemical assessment of proliferation using the marker Ki67 has potential use in both research and clinical management. However, lack of consistency across laboratories has limited Ki67’s value. A working group was assembled to devise a strategy to harmonize Ki67 analysis and increase scoring concordance. Toward that goal, we conducted a Ki67 reproducibility study. Methods Eight laboratories received 100 breast cancer cases arranged into 1-mm core tissue microarrays—one set stained by the participating laboratory and one set stained by the central laboratory, both using antibody MIB-1. Each laboratory scored Ki67 as percentage of positively stained invasive tumor cells using its own method. Six laboratories repeated scoring of 50 locally stained cases on 3 different days. Sources of variation were analyzed using random effects models with log2-transformed measurements. Reproducibility was quantified by intraclass correlation coefficient (ICC), and the approximate two-sided 95% confidence intervals (CIs) for the true intraclass correlation coefficients in these experiments were provided. Results Intralaboratory reproducibility was high (ICC = 0.94; 95% CI = 0.93 to 0.97). Interlaboratory reproducibility was only moderate (central staining: ICC = 0.71, 95% CI = 0.47 to 0.78; local staining: ICC = 0.59, 95% CI = 0.37 to 0.68). Geometric mean of Ki67 values for each laboratory across the 100 cases ranged 7.1% to 23.9% with central staining and 6.1% to 30.1% with local staining. Factors contributing to interlaboratory discordance included tumor region selection, counting method, and subjective assessment of staining positivity. Formal counting methods gave more consistent results than visual estimation. Conclusions Substantial variability in Ki67 scoring was observed among some of the world’s most experienced laboratories. Ki67 values and cutoffs for clinical decision-making cannot be transferred between laboratories without standardizing scoring methodology because analytical validity is limited. PMID:24203987

33 CFR 209.340 - Laboratory investigations and materials testing.

Code of Federal Regulations, 2010 CFR

2010-07-01

... hydraulic laboratories, and to the Inter-Agency Sedimentation Project. (c) References. (1) AR 37-20. (2) AR... ordinary business channels. (3) Performance of the work will not interfere with provisions of services... with the same procedures as apply to Division Materials Laboratories. (3) Inter-Agency Sedimentation...

33 CFR 209.340 - Laboratory investigations and materials testing.

Code of Federal Regulations, 2011 CFR

2011-07-01

... hydraulic laboratories, and to the Inter-Agency Sedimentation Project. (c) References. (1) AR 37-20. (2) AR... ordinary business channels. (3) Performance of the work will not interfere with provisions of services... with the same procedures as apply to Division Materials Laboratories. (3) Inter-Agency Sedimentation...

40 CFR 792.105 - Test, control, and reference substance characterization.

Code of Federal Regulations, 2011 CFR

2011-07-01

... or concomitantly according to written standard operating procedures, which provide for periodic...) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference...

40 CFR 792.105 - Test, control, and reference substance characterization.

Code of Federal Regulations, 2014 CFR

2014-07-01

... or concomitantly according to written standard operating procedures, which provide for periodic...) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference...

40 CFR 792.105 - Test, control, and reference substance characterization.

Code of Federal Regulations, 2013 CFR

2013-07-01

... or concomitantly according to written standard operating procedures, which provide for periodic...) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference...

40 CFR 792.105 - Test, control, and reference substance characterization.

Code of Federal Regulations, 2012 CFR

2012-07-01

... or concomitantly according to written standard operating procedures, which provide for periodic...) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference...

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

PubMed

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

2015-01-01

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

[Epidemiology of parechovirus infections of the central nervous system in a French pediatric unit].

PubMed

Escuret, A; Mirand, A; Dommergues, M-A; Couzon, B; Foucaud, P; Peigue-Lafeuille, H; Marque-Juillet, S

2013-05-01

Human parechoviruses (HPeV), like their counterpart enteroviruses (EV), are associated with clinical manifestations ranging from asymptomatic disease to infections of the central nervous system. Newborn and young infants are particularly at risk for severe infection. In the last 5 years, the molecular diagnosis of HPeV infection in cerebrospinal fluid (CSF) and the identification of the associated HPeV type revealed the specific association between HPeV3 and meningitis or sepsis-like illness in neonates and infants. HPeV infection is not yet routinely diagnosed in clinical virology laboratories. To determine the clinical, biological, and epidemiological characteristics of HPeV infections of patients hospitalized at the Centre Hospitalier de Versailles, France. A total of 380 CSF samples originally referred to our laboratory for enterovirus testing between January 1st, 2007 and August 31st, 2011, were selected and retrospectively screened for the genome detection of HPeV. All HPeV detected were identified by amplification and sequencing of the complete 1D sequence encoding the VP1 protein. The HPeV genome was detected in CSF samples from nine (2.8%) patients. All were young infants under 18 months of age (median, 30 days; age range, 8 days to 18 months). Fever was observed for all children and eight out of nine (89%) presented with irritability. No pleiocytosis and normal glucose and protein levels were observed. The mean duration of the hospital stay was 4 days (range, 2-7 days) and antibiotics were administered to five patients (55.6%). Yearly frequency of genome detection varied remarkably: 1.1% in 2007, 0% in 2008 and 2011, 2.9% in 2009 and 7.1% in 2010. All genotyped viruses were HPeV3. This study confirmed the importance of the HPeV genome detection in CSF samples from patients presenting with sepsis-like illness or suspected infection of the central nervous system, particularly in children under 2 years of age. The introduction of the molecular diagnosis of HPeV infection broadens the panel of diagnosis of neonatal sepsis and central nervous system symptoms in young children. Rapid identification of HPeV by PCR could also contribute to shorter duration of both antibiotic use and hospital stay. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

Implications of false positive serology of Toxoplasma gondii in a pre-transplant patient.

PubMed

Beal, Stacy; Racsa, Lori; Alatoom, Adnan

2014-01-01

A 21-year-old white male with cystic fibrosis. Pre-transplant workup in preparation for bilateral lung transplant. Cystic fibrosis diagnosed at age 3, onset of insulin-dependent diabetes around age 20, and multiple hospitalizations for pulmonary and gastrointestinal complications. FAMILY AND SOCIAL HISTORY: The patient lives with his father and stepmother, has a pet bearded dragon, and has multiple tattoos and piercings. His stepmother has a cat, but he does not clean the litter box. The pre-transplant workup included several tests for infectious diseases, tests of organ function, radiology studies, and markers of malignancy. The only significant finding was a positive Toxoplasma gondii (T. gondii) IgM titer (> or = 1:40) (reference values for IgM: negative; < 1:40, positive; > or = 1:40) and IgG (1:2048) (reference values for IgG: negative; < 1:16, equivocal; > or = 1:16 - < 1:256, positive; > or = 1:256). Testing was done by indirect immunofluorescence assay (IFA) in April 2012 in our hospital laboratory. The patient was treated with sulfadiazine, leucovorin, and pyrimethamine. Three months later (July), he returned for follow-up testing. Real-time polymerase chain reaction (PCR) for T. gondii DNA performed by a reference laboratory was negative. One month later (August), Toxoplasma serology was performed by enzyme-linked immunosorbent assay (ELISA) by a different reference laboratory and showed an elevated IgM of 0.95 IU/mL (reference values: negative; < 0.55 IU/mL, equivocal; > or = 0.55- < 0.65 IU/mL, positive; > or = 0.65 IU/mL) and a normal level of IgG (< 4 IU/mL). At this time, PCR was repeated and was negative. An additional month later (September), the patient's serology studies were performed at a third reference laboratory and showed an elevated IgM of 1.32 IU/mL (reference values: negative; 0.89, equivocal; 0.90 - 1.09, positive; > 1.10) and a normal IgG.

40 CFR 792.107 - Test, control, and reference substance handling.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 31 2010-07-01 2010-07-01 true Test, control, and reference substance handling. 792.107 Section 792.107 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference...

Estimating clinical chemistry reference values based on an existing data set of unselected animals.

PubMed

Dimauro, Corrado; Bonelli, Piero; Nicolussi, Paola; Rassu, Salvatore P G; Cappio-Borlino, Aldo; Pulina, Giuseppe

2008-11-01

In an attempt to standardise the determination of biological reference values, the International Federation of Clinical Chemistry (IFCC) has published a series of recommendations on developing reference intervals. The IFCC recommends the use of an a priori sampling of at least 120 healthy individuals. However, such a high number of samples and laboratory analysis is expensive, time-consuming and not always feasible, especially in veterinary medicine. In this paper, an alternative (a posteriori) method is described and is used to determine reference intervals for biochemical parameters of farm animals using an existing laboratory data set. The method used was based on the detection and removal of outliers to obtain a large sample of animals likely to be healthy from the existing data set. This allowed the estimation of reliable reference intervals for biochemical parameters in Sarda dairy sheep. This method may also be useful for the determination of reference intervals for different species, ages and gender.

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

How do laboratory technicians perceive their role in the tuberculosis diagnostic process? A cross-sectional study among laboratory technicians in health centers of Central Java Province, Indonesia

PubMed Central

Widjanarko, Bagoes; Widyastari, Dyah Anantalia; Martini, Martini; Ginandjar, Praba

2016-01-01

Purpose Detection of acid-fast bacilli in respiratory specimens serves as an initial pulmonary tuberculosis (TB) diagnosis. Laboratories are the essential and fundamental part of all health systems. This study aimed to describe how laboratory technicians perceived their own self and work. This included perceived self-efficacy, perceived role, perceived equipment availability, perceived procedures, perceived reward and job, and perceived benefit of health education, as well as level of knowledge and attitudes related to work performance of laboratory technicians. Methods This was a cross-sectional quantitative study involving 120 laboratory technicians conducted in Central Java. Interviews and observation were conducted to measure performance and work-related variables. Results Among 120 laboratory technicians, 43.3% showed fairly good performance. They complied with 50%–75% of all procedures, including sputum collection, laboratory tools utilization, sputum smearing, staining, smear examination, grading of results, and universal precaution practice. Perceived role, perceived self-efficacy, and knowledge of laboratory procedures were significantly correlated to performance, besides education and years of working as a laboratory technician. Perceived equipment availability was also significantly correlated to performance after the education variable was controlled. Conclusion Most of the laboratory technicians believed that they have an important role in TB patients’ treatment and should display proper self-efficacy in performing laboratory activities. The result may serve as a basic consideration to develop a policy for enhancing motivation of laboratory technicians in order to improve the TB control program. PMID:27660502

LABORATORY DESIGN CONSIDERATIONS FOR SAFETY.

ERIC Educational Resources Information Center

National Safety Council, Chicago, IL. Campus Safety Association.

THIS SET OF CONSIDERATIONS HAS BEEN PREPARED TO PROVIDE PERSONS WORKING ON THE DESIGN OF NEW OR REMODELED LABORATORY FACILITIES WITH A SUITABLE REFERENCE GUIDE TO DESIGN SAFETY. THERE IS NO DISTINCTION BETWEEN TYPES OF LABORATORY AND THE EMPHASIS IS ON GIVING GUIDES AND ALTERNATIVES RATHER THAN DETAILED SPECIFICATIONS. AREAS COVERED INCLUDE--(1)…

46 CFR 25.01-3 - Incorporation by reference.

Code of Federal Regulations, 2013 CFR

2013-10-01

..., Devices Providing Backfire Flame Control for Gasoline Engines in Marine Applications, June 1989 25.35-1 Underwriter's Laboratories (UL) 12 Laboratory Drive, Research Triangle Park, NC 27709 UL 1111, Marine...

46 CFR 25.01-3 - Incorporation by reference.

Code of Federal Regulations, 2014 CFR

2014-10-01

..., Devices Providing Backfire Flame Control for Gasoline Engines in Marine Applications, June 1989 25.35-1 Underwriter's Laboratories (UL) 12 Laboratory Drive, Research Triangle Park, NC 27709 UL 1111, Marine...

46 CFR 25.01-3 - Incorporation by reference.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Drive, Warrendale, PA 15096 SAE J-1928, Devices Providing Backfire Flame Control for Gasoline Engines in Marine Applications, June 1989 25.35-1 Underwriter's Laboratories (UL) 12 Laboratory Drive, Research...

Bibliographic Control in South Africa

ERIC Educational Resources Information Center

Musiker, Reuben

1972-01-01

The author sets as his task the consideration of the present state of bibliographical control of South Africa's bookstock with special reference to centralization and decentralization. (20 references) (Author/SJ)

GHEP-ISFG collaborative simulated exercise for DVI/MPI: Lessons learned about large-scale profile database comparisons.

PubMed

Vullo, Carlos M; Romero, Magdalena; Catelli, Laura; Šakić, Mustafa; Saragoni, Victor G; Jimenez Pleguezuelos, María Jose; Romanini, Carola; Anjos Porto, Maria João; Puente Prieto, Jorge; Bofarull Castro, Alicia; Hernandez, Alexis; Farfán, María José; Prieto, Victoria; Alvarez, David; Penacino, Gustavo; Zabalza, Santiago; Hernández Bolaños, Alejandro; Miguel Manterola, Irati; Prieto, Lourdes; Parsons, Thomas

2016-03-01

The GHEP-ISFG Working Group has recognized the importance of assisting DNA laboratories to gain expertise in handling DVI or missing persons identification (MPI) projects which involve the need for large-scale genetic profile comparisons. Eleven laboratories participated in a DNA matching exercise to identify victims from a hypothetical conflict with 193 missing persons. The post mortem database was comprised of 87 skeletal remain profiles from a secondary mass grave displaying a minimal number of 58 individuals with evidence of commingling. The reference database was represented by 286 family reference profiles with diverse pedigrees. The goal of the exercise was to correctly discover re-associations and family matches. The results of direct matching for commingled remains re-associations were correct and fully concordant among all laboratories. However, the kinship analysis for missing persons identifications showed variable results among the participants. There was a group of laboratories with correct, concordant results but nearly half of the others showed discrepant results exhibiting likelihood ratio differences of several degrees of magnitude in some cases. Three main errors were detected: (a) some laboratories did not use the complete reference family genetic data to report the match with the remains, (b) the identity and/or non-identity hypotheses were sometimes wrongly expressed in the likelihood ratio calculations, and (c) many laboratories did not properly evaluate the prior odds for the event. The results suggest that large-scale profile comparisons for DVI or MPI is a challenge for forensic genetics laboratories and the statistical treatment of DNA matching and the Bayesian framework should be better standardized among laboratories. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

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

2011 Annual Wastewater Reuse Report for the Idaho National Laboratory Site’s Central Facilities Area Sewage Treatment Plant

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

Michael G. Lewis

2012-02-01

This report describes conditions, as required by the state of Idaho Wastewater Reuse Permit (LA-000141-03), for the wastewater land application site at Idaho National Laboratory Site's Central Facilities Area Sewage Treatment Plant from November 1, 2010, through October 31, 2011. The report contains the following information: (1) Site description; (2) Facility and system description; (3) Permit required monitoring data and loading rates; (4) Status of special compliance conditions and activities; and (5) Discussion of the facility's environmental impacts. During the 2011 permit year, approximately 1.22 million gallons of treated wastewater was land-applied to the irrigation area at Central Facilities Areamore » Sewage Treatment plant.« less

40 CFR 160.107 - Test, control, and reference substance handling.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Test, control, and reference substance handling. 160.107 Section 160.107 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.107 Test...

Bushland Reference ET Calculator with QA/QC capabilities and iPhone/iPad application

USDA-ARS?s Scientific Manuscript database

Accurate daily reference evapotranspiration (ET) values are needed to estimate crop water demand for irrigation management and hydrologic modeling purposes. The USDA-ARS Conservation and Production Research Laboratory at Bushland, Texas developed the Bushland Reference ET (BET) Calculator for calcul...

21 CFR 660.52 - Reference preparations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Reference preparations. 660.52 Section 660.52 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Anti-Human Globulin § 660.52 Reference...

21 CFR 660.3 - Reference panel.

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Antibody to Hepatitis B Surface Antigen § 660.3 Reference panel. A Reference Hepatitis B Surface Antigen Panel shall be obtained from the Center... shall be used for determining the potency and specificity of Antibody to Hepatitis B Surface Antigen...

21 CFR 660.3 - Reference panel.

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Antibody to Hepatitis B Surface Antigen § 660.3 Reference panel. A Reference Hepatitis B Surface Antigen Panel shall be obtained from the Center... shall be used for determining the potency and specificity of Antibody to Hepatitis B Surface Antigen...

21 CFR 660.3 - Reference panel.

Code of Federal Regulations, 2011 CFR

2011-04-01

... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Antibody to Hepatitis B Surface Antigen § 660.3 Reference panel. A Reference Hepatitis B Surface Antigen Panel shall be obtained from the Center for... used for determining the potency and specificity of Antibody to Hepatitis B Surface Antigen. [40 FR...

21 CFR 660.3 - Reference panel.

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Antibody to Hepatitis B Surface Antigen § 660.3 Reference panel. A Reference Hepatitis B Surface Antigen Panel shall be obtained from the Center... shall be used for determining the potency and specificity of Antibody to Hepatitis B Surface Antigen...

21 CFR 660.3 - Reference panel.

Code of Federal Regulations, 2010 CFR

2010-04-01

... ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Antibody to Hepatitis B Surface Antigen § 660.3 Reference panel. A Reference Hepatitis B Surface Antigen Panel shall be obtained from the Center... shall be used for determining the potency and specificity of Antibody to Hepatitis B Surface Antigen...

Collaborative study for the calibration of replacement batches for the heparin low-molecular-mass for assay biological reference preparation.

PubMed

Terao, E; Daas, A

2016-01-01

The European Pharmacopoeia (Ph. Eur.) prescribes the control of the activity of low molecular mass heparins by assays for anti-Xa and anti-IIa activities (monograph 0828), using a reference standard calibrated in International Units (IU). An international collaborative study coded BSP133 was launched in the framework of the Biological Standardisation Programme (BSP) run under the aegis of the Council of Europe and the European Commission to calibrate replacement batches for the dwindling stocks of the Heparin low-molecular-mass for assay Biological Reference Preparation (BRP) batch 8. Thirteen official medicines control and manufacturers laboratories from European and non-European countries took part in this study to calibrate two freeze-dried candidate batches against the 3rd International Standard (IS) for heparin, low molecular weight (11/176; 3rd IS). The Heparin low-molecular-mass for assay BRP (batch 8) was also included in the test panel to check the continuity between subsequent BRP batches. Taking into account the stability data, the results of this collaborative study and on the basis of the central statistical analysis performed at the European Directorate for the Quality of Medicines & HealthCare (EDQM), the 2 candidate batches were officially adopted by the Commission of the European Pharmacopoeia as Heparin low-molecular-mass for assay BRP batches 9 and 10 with assigned anti-Xa activities of 102 and 100 IU/vial and anti-IIa activities of 34 and 33 IU/vial respectively.

Current status of verification practices in clinical biochemistry in Spain.

PubMed

Gómez-Rioja, Rubén; Alvarez, Virtudes; Ventura, Montserrat; Alsina, M Jesús; Barba, Núria; Cortés, Mariano; Llopis, María Antonia; Martínez, Cecilia; Ibarz, Mercè

2013-09-01

Verification uses logical algorithms to detect potential errors before laboratory results are released to the clinician. Even though verification is one of the main processes in all laboratories, there is a lack of standardization mainly in the algorithms used and the criteria and verification limits applied. A survey in clinical laboratories in Spain was conducted in order to assess the verification process, particularly the use of autoverification. Questionnaires were sent to the laboratories involved in the External Quality Assurance Program organized by the Spanish Society of Clinical Biochemistry and Molecular Pathology. Seven common biochemical parameters were included (glucose, cholesterol, triglycerides, creatinine, potassium, calcium, and alanine aminotransferase). Completed questionnaires were received from 85 laboratories. Nearly all the laboratories reported using the following seven verification criteria: internal quality control, instrument warnings, sample deterioration, reference limits, clinical data, concordance between parameters, and verification of results. The use of all verification criteria varied according to the type of verification (automatic, technical, or medical). Verification limits for these parameters are similar to biological reference ranges. Delta Check was used in 24% of laboratories. Most laboratories (64%) reported using autoverification systems. Autoverification use was related to laboratory size, ownership, and type of laboratory information system, but amount of use (percentage of test autoverified) was not related to laboratory size. A total of 36% of Spanish laboratories do not use autoverification, despite the general implementation of laboratory information systems, most of them, with autoverification ability. Criteria and rules for seven routine biochemical tests were obtained.

46 CFR 25.01-3 - Incorporation by reference.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., PA 15096 SAE J-1928, Devices Providing Backfire Flame Control for Gasoline Engines in Marine Applications, June 1989 25.35-1 Underwriter's Laboratories (UL) 12 Laboratory Drive, Research Triangle Park, NC...

46 CFR 25.01-3 - Incorporation by reference.

Code of Federal Regulations, 2011 CFR

2011-10-01

..., PA 15096 SAE J-1928, Devices Providing Backfire Flame Control for Gasoline Engines in Marine Applications, June 1989 25.35-1 Underwriter's Laboratories (UL) 12 Laboratory Drive, Research Triangle Park, NC...

A Laboratory-Based Nonlinear Dynamics Course for Science and Engineering Students.

ERIC Educational Resources Information Center

Sungar, N.; Sharpe, J. P.; Moelter, M. J.; Fleishon, N.; Morrison, K.; McDill, J.; Schoonover, R.

2001-01-01

Describes the implementation of a new laboratory-based, interdisciplinary undergraduate course on linear dynamical systems. Focuses on geometrical methods and data visualization techniques. (Contains 20 references.) (Author/YDS)

The OIE World Animal Health Information System: the role of OIE Reference Laboratories and Collaborating Centres in disease reporting.

PubMed

Ben Jebara, K

2010-12-01

One of the main objectives of the World Organisation for Animal Health (OIE) is to ensure transparency in and knowledge of the world animal health situation. To achieve this objective, the OIE relies on its network of Member Countries, which is complemented by the activities of 221 Reference Laboratories (RLs) and Collaborating Centres. The RL mandate states that, in the case of positive results for diseases notifiable to the OIE, the laboratory should inform the OIE Delegate of the Member Country from which the samples originated and send a copy of the information to OIE Headquarters. However, since 2006 the OIE has received a lower than expected number of notifications from RLs, which implies eitherthat the majority of samples are sent to national laboratories or that some RLs are not fully complying with their mandate. The OIE sent a questionnaire to RLs in preparation for the Second Global Conference of OIE Reference Laboratories and Collaborating Centres (Paris, France, 21-23 June 2010). Two main factors emerged: the need for RLs to clarify their role and responsibilities in disease reporting and the need for an awareness campaign to sensitise national Veterinary Services to the importance of conducting more surveillance (and consequently of submitting samples to RLs) for all OIE-listed diseases. Reference laboratories indicated two main reasons for not sharing more data on positive samples with the OIE: i) a perceived contradiction between their mandate as OIE RLs and the standards of the International Organization for Standardization (ISO) dealing with confidentiality; and ii) certain Member Countries or stakeholders asking RLs not to share positive results with the OIE, for political or economic reasons. The OIE has put forward proposals to help RLs resolve these problems in future. The use of ISO standards must be clarified and there must be improved communication between the OIE and its RLs. A lack of transparency about a significant disease event can jeopardise the biosecurity of several countries, an entire region or even the whole world. The reference status of a non-transparent RL could be questioned.

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.

Impact of removing mucosal barrier injury laboratory-confirmed bloodstream infections from central line-associated bloodstream infection rates in the National Healthcare Safety Network, 2014.

PubMed

See, Isaac; Soe, Minn M; Epstein, Lauren; Edwards, Jonathan R; Magill, Shelley S; Thompson, Nicola D

2017-03-01

Central line-associated bloodstream infection (CLABSI) event data reported to the National Healthcare Safety Network from 2014, the first year of required use of the mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI) definition, were analyzed to assess the impact of removing MBI-LCBI events from CLABSI rates. CLABSI rates decreased significantly in some location types after removing MBI-LCBI events, and MBI-LCBI events will be removed from publicly reported CLABSI rates. Published by Elsevier Inc.

Electromagnetic Measurements Conducted by the Central Radio Propagation Laboratory During Operation Upshot-Knothole (Redacted)

DTIC Science & Technology

1954-03-31

b . ABSTRACT c. THIS PAGE 19b. TELEPHONE NUMBER (include area code) Standard Form 298 (Re . 8-98) v Prescribed by ANSI Std. Z39.18 31...March 1954 Final report Electromagnetic Measurements Conducted by the Central Radio Propagation Laboratory During Operation Upshot-Knothole B /216/E...Vubington 25, D. C. COD fw 5 U.S.C. § 552 ( b )( 6) O££ice (or AtOIIIie Fnergy, DCS/0 r r T l A . O!tp1rtment o£ the 1\\ir force \\ ·-’ . If

On Deciding How to Decide: To Centralize or Decentralize.

ERIC Educational Resources Information Center

Chaffee, Ellen Earle

Issues concerning whether to centralize or decentralize decision-making are addressed, with applications for colleges. Centralization/decentralization (C/D) must be analyzed with reference to a particular decision. Three components of C/D are locus of authority, breadth of participation, and relative contribution by the decision-maker's staff. C/D…

Increased arterial stiffness in children with congenital heart disease.

PubMed

Häcker, Anna-Luisa; Reiner, Barbara; Oberhoffer, Renate; Hager, Alfred; Ewert, Peter; Müller, Jan

2018-01-01

Objective Central systolic blood pressure (SBP) is a measure of arterial stiffness and strongly associated with atherosclerosis and end-organ damage. It is a stronger predictor of cardiovascular events and all-cause mortality than peripheral SBP. In particular, for children with congenital heart disease, a higher central SBP might impose a greater threat of cardiac damage. The aim of the study was to analyse and compare central SBP in children with congenital heart disease and in healthy counterparts. Patients and methods Central SBP was measured using an oscillometric method in 417 children (38.9% girls, 13.0 ± 3.2 years) with various congenital heart diseases between July 2014 and February 2017. The test results were compared with a recent healthy reference cohort of 1466 children (49.5% girls, 12.9 ± 2.5 years). Results After correction for several covariates in a general linear model, central SBP of children with congenital heart disease was significantly increased (congenital heart disease: 102.1 ± 10.2 vs. healthy reference cohort: 100.4 ± 8.6, p < .001). The analysis of congenital heart disease subgroups revealed higher central SBP in children with left heart obstructions (mean difference: 3.6 mmHg, p < .001), transpositions of the great arteries after arterial switch (mean difference: 2.2 mmHg, p = .017) and univentricular hearts after total cavopulmonary connection (mean difference: 2.1 mmHg, p = .015) compared with the reference. Conclusion Children with congenital heart disease have significantly higher central SBP compared with healthy peers, predisposing them to premature heart failure. Screening and long-term observations of central SBP in children with congenital heart disease seems warranted in order to evaluate the need for treatment.

40 CFR 98.284 - Monitoring and QA/QC requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

..., Hydrogen, and Nitrogen in Laboratory Samples of Coal (incorporated by reference, see § 98.7). (d) For... Instrumental Determination of Carbon, Hydrogen, and Nitrogen in Laboratory Samples of Coal (incorporated by...

40 CFR 98.284 - Monitoring and QA/QC requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

..., Hydrogen, and Nitrogen in Laboratory Samples of Coal (incorporated by reference, see § 98.7). (d) For... Instrumental Determination of Carbon, Hydrogen, and Nitrogen in Laboratory Samples of Coal (incorporated by...

40 CFR 98.284 - Monitoring and QA/QC requirements.

Code of Federal Regulations, 2012 CFR

2012-07-01

..., Hydrogen, and Nitrogen in Laboratory Samples of Coal (incorporated by reference, see § 98.7). (d) For... Instrumental Determination of Carbon, Hydrogen, and Nitrogen in Laboratory Samples of Coal (incorporated by...

40 CFR 98.284 - Monitoring and QA/QC requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

..., Hydrogen, and Nitrogen in Laboratory Samples of Coal (incorporated by reference, see § 98.7). (d) For... Instrumental Determination of Carbon, Hydrogen, and Nitrogen in Laboratory Samples of Coal (incorporated by...

Are Your Cells Pregnant? Relating Biology Laboratory Exercises to Everyday Life.

ERIC Educational Resources Information Center

Rhodes, Simon J.; Banner, Lisa R.

2001-01-01

Presents a laboratory exercise that allows students to investigate the principles of hormone release from endocrine cells, which is highly relevant to students' everyday lives. (Contains 17 references.) (ASK)

Publications - GMC 367 | Alaska Division of Geological & Geophysical

Science.gov Websites

. Minerals Management Service, and Core Laboratories Publication Date: Aug 2009 Publisher: Alaska Division of Bibliographic Reference U.S. Minerals Management Service, and Core Laboratories, 2009, Sidewall core analyses

46 CFR 160.076-11 - Incorporation by reference.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Laboratories, Inc., 12 Laboratory Drive, Research Triangle Park, NC 27709-3995 (Phone (919) 549-1400; Facsimile... affected are as follows: American Society for Testing and Materials (ASTM) 100 Barr Harbor Drive, West...

[Capability of national reference laboratories in Latin America to detect emerging resistance mechanisms].

PubMed

Corso, Alejandra; Guerriero, Leonor; Pasterán, Fernando; Ceriana, Paola; Callejo, Raquel; Prieto, Mónica; Tuduri, Ezequiel; Lopardo, Horacio; Vay, Carlos; Smayevsky, Jorgelina; Tokumoto, Marta; Alvarez, Jorge Matheu; Pardo, Pilar Ramón; Galas, Marcelo

2011-12-01

To evaluate the capability of 17 national reference laboratories participating in the Latin American Quality Control Program in Bacteriology and Antibiotic Resistance (LA-EQAS) to detect emerging resistance mechanisms- namely: resistance of enterobacteria to carbapenems due to the presence of Klebsiella pneumoniae carbapenemase (KPC) and metallo-beta-lactamase (MBL) type IMP, and intermediate resistance of Staphylococcus aureus isolates to vancomycin (vancomycin-intermediate resistant S. aureus-VISA). The following three isolates were sent to the 17 participating LA-EQAS laboratories: KPC -producing Klebsiella pneumoniae PAHO-161, IMP-producing Enterobacter cloacae PAHO-166, and S. aureus PAHO-165 with intermediate resistance to vancomycin. Performance of each of the following operations was evaluated: interpretation of sensitivity tests, detection of the resistance mechanism, and assessment of either inhibition halo size (disk diffusion method) or minimum inhibitory concentration (MIC). Concordance in the detection of resistance mechanisms was 76.4%, 73.3%, and 66.7% for the K. pneumoniae PAHO-161, E. cloacae PAHO-166, and S. aureus PAHO-165 strains, respectively. Concordance between the inhibition areas observed by the participating laboratories and the ranges established by the coordinating laboratory was acceptable for all three isolates, at 90.8%, 92.8%, and 88.9%, respectively. Overall concordance in on the detection of KPC, MBL, and VISA resistance mechanisms was 72.1%. We consider the national reference laboratories in Latin America capable of recognizing these emerging resistance mechanisms and expect that maximum levels of concordance will be reached in the future.

The use of reference change values in clinical laboratories.

PubMed

Bugdayci, Guler; Oguzman, Hamdi; Arattan, Havva Yasemin; Sasmaz, Guler

2015-01-01

The use of Reference Change Values (RCV) has been advocated as very useful for monitoring individuals. Most of these are performed for monitoring individuals in acute situations and for following up the improvement or deterioration of chronic diseases. In our study, we aimed at evaluating the RCV calculation for 24 clinical chemistry analytes widely used in clinical laboratories and the utilization of this data. Twenty-four serum samples were analyzed with Abbott kits (Abbott Laboratories, Abbott Park, IL, USA), manufactured for use with the Architect c8000 (Abbott Laboratories, Abbott Park, IL, USA) auto-analyzer. We calculated RCV using the following formula: RCV = Z x 2 1/2x (CVA2 + CVw2)1/2. Four reference change values (RCV) were calculated for each analyte using four statistical probabilities (0.95, and 0.99, unidirectional and bidirectional). Moreover, by providing an interval after identifying upper and lower limits with the Reference Change Factor (RCF), serially measured tests were calculated by using two formulas: exp (Z x 2 1/2 x (CV(A)2 + CVw2)½/100) for RCF(UP) and (1/RCF(UP)) for RCF(DOWN). RCVs of these analytes were calculated as 14.63% for glucose, 29.88% for urea, 17.75% for ALP, 53.39% for CK, 46.98% for CK-MB, 21.00% amylase, 8.00% for total protein, 8.70% for albumin, 51.08% for total bilirubin, 86.34% for direct bilirubin, 6.40% for calcium, 15.03% for creatinine, 21.47% for urate, 14.19% for total cholesterol, 46.62% for triglyceride, 20.51% for HDL-cholesterol, 29.59% for AST, 46.31% for ALT, 31.54% for GGT, 20.92% for LDH, 19.75% for inorganic phosphate, 3.05% for sodium, 11.75% for potassium, 4.44% for chloride (RCV, p < 0.05, unidirectionally). We suggest using RCV as well as using population-based reference intervals in clinical laboratories. RCV could be available as a tool for making clinical decision, especially when monitoring individuals.

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.

Reference intervals for 24 laboratory parameters determined in 24-hour urine collections.

PubMed

Curcio, Raffaele; Stettler, Helen; Suter, Paolo M; Aksözen, Jasmin Barman; Saleh, Lanja; Spanaus, Katharina; Bochud, Murielle; Minder, Elisabeth; von Eckardstein, Arnold

2016-01-01

Reference intervals for many laboratory parameters determined in 24-h urine collections are either not publicly available or based on small numbers, not sex specific or not from a representative sample. Osmolality and concentrations or enzymatic activities of sodium, potassium, chloride, glucose, creatinine, citrate, cortisol, pancreatic α-amylase, total protein, albumin, transferrin, immunoglobulin G, α1-microglobulin, α2-macroglobulin, as well as porphyrins and their precursors (δ-aminolevulinic acid and porphobilinogen) were determined in 241 24-h urine samples of a population-based cohort of asymptomatic adults (121 men and 120 women). For 16 of these 24 parameters creatinine-normalized ratios were calculated based on 24-h urine creatinine. The reference intervals for these parameters were calculated according to the CLSI C28-A3 statistical guidelines. By contrast to most published reference intervals, which do not stratify for sex, reference intervals of 12 of 24 laboratory parameters in 24-h urine collections and of eight of 16 parameters as creatinine-normalized ratios differed significantly between men and women. For six parameters calculated as 24-h urine excretion and four parameters calculated as creatinine-normalized ratios no reference intervals had been published before. For some parameters we found significant and relevant deviations from previously reported reference intervals, most notably for 24-h urine cortisol in women. Ten 24-h urine parameters showed weak or moderate sex-specific correlations with age. By applying up-to-date analytical methods and clinical chemistry analyzers to 24-h urine collections from a large population-based cohort we provide as yet the most comprehensive set of sex-specific reference intervals calculated according to CLSI guidelines for parameters determined in 24-h urine collections.

Employment references: defamation law in the clinical laboratory.

PubMed

Parks, D G

1993-01-01

The law of defamation and the risks involved in issuing employment references are discussed. A hypothetical scenario is used to illustrate the legal standards governing the tort of defamation and to apply those standards to employment references. Practical suggestions for a "controlled reference" policy are provided, with the objective of allowing for responsible exchange of employment information and avoiding a defamation lawsuit.

Advanced Food Science and Nutrition Reference Book.

ERIC Educational Resources Information Center

Texas Tech Univ., Lubbock. Home Economics Curriculum Center.

Developed with input from personnel in the industries, this reference book complements the curriculum guide for a laboratory course on the significance of nutrition in food science. The reference book is organized into 25 chapters, each beginning with essential elements and objectives. Within the text, italicized, bold-faced vocabulary terms are…

A simple method for the small scale synthesis and solid-phase extraction purification of steroid sulfates.

PubMed

Waller, Christopher C; McLeod, Malcolm D

2014-12-01

Steroid sulfates are a major class of steroid metabolite that are of growing importance in fields such as anti-doping analysis, the detection of residues in agricultural produce or medicine. Despite this, many steroid sulfate reference materials may have limited or no availability hampering the development of analytical methods. We report simple protocols for the rapid synthesis and purification of steroid sulfates that are suitable for adoption by analytical laboratories. Central to this approach is the use of solid-phase extraction (SPE) for purification, a technique routinely used for sample preparation in analytical laboratories around the world. The sulfate conjugates of sixteen steroid compounds encompassing a wide range of steroid substitution patterns and configurations are prepared, including the previously unreported sulfate conjugates of the designer steroids furazadrol (17β-hydroxyandrostan[2,3-d]isoxazole), isofurazadrol (17β-hydroxyandrostan[3,2-c]isoxazole) and trenazone (17β-hydroxyestra-4,9-dien-3-one). Structural characterization data, together with NMR and mass spectra are reported for all steroid sulfates, often for the first time. The scope of this approach for small scale synthesis is highlighted by the sulfation of 1μg of testosterone (17β-hydroxyandrost-4-en-3-one) as monitored by liquid chromatography-mass spectrometry (LCMS). Copyright © 2014 Elsevier Inc. All rights reserved.

An update on the use of cerebrospinal fluid analysis as a diagnostic tool in multiple sclerosis.

PubMed

Gastaldi, Matteo; Zardini, Elisabetta; Franciotta, Diego

2017-01-01

Intrathecal B-lymphocyte activation is a hallmark of multiple sclerosis (MS), a multi-factorial inflammatory-demyelinating disease of the central nervous system. Such activation has a counterpart in the cerebrospinal fluid (CSF) oligoclonal IgG bands (OCB), whose diagnostic role in MS has been downgraded within the current McDonald's criteria. With a theoretico-practical approach, the authors review the physiopathological basis of the CSF dynamics, and the state-of-the-art of routine CSF analysis and CSF biomarkers in MS. Areas covered: The authors discuss pros and cons of CSF analysis, including critical evaluations of both well-established, and promising diagnostic and prognostic laboratory tools. New acquisitions on the CSF and cerebral interstitial fluid dynamics are also presented. The authors searched the PubMed database for English-language articles reported between January 2010 and June 2016, using the key words 'multiple sclerosis', 'cerebrospinal fluid', 'oligoclonal bands'. Reference lists of relevant articles were scanned for additional studies. Expert commentary: The availability of performing high-quality, routine CSF tests in specialized laboratories, the emerging potential of novel CSF biomarkers, and the trend for early treatments should induce a reappraisal of CSF analysis for diagnostic and prognostic purposes in MS. Further procedural and methodological improvements seem to be necessary in both research and translational diagnostic CSF settings.

Screening retreatment tuberculosis patients for drug resistance in mid-west Nepal: how well are we doing?

PubMed Central

Harries, A. D.; Goel, S.; Srivastava, S.; Kumar, A. M. V.; Adhikari, M.; Shrestha, B.; Maharjan, B.; Khadka, H.

2014-01-01

Setting: Multidrug-resistant tuberculosis (MDR-TB, defined as resistance to isoniazid and rifampicin) is poorly detected in Nepal; one reason may be poor functioning of culture and drug susceptibility testing (CDST) services for retreatment tuberculosis (TB) patients. Objectives: To determine, among retreatment TB patients in mid-west Nepal, 1) the number of patients registered for treatment between July 2011 and July 2012; 2) the number submitting sputum specimens for CDST to the Central Reference Laboratory (CRL), Kathmandu, along with the results; and 3) the length of time for submission and receipt of specimens. Design: Retrospective cohort study involving the review of treatment and laboratory registers from the Nepalgunj TB Referral Centre and the CRL. Results: Of 431 retreatment patients, 66 (15%) submitted sputum samples, of which 63 reached the CRL. Of these, 39 (62%) were culture-positive; 13 (33%) patients had MDR-TB. The CDST results of 19 patients were received back at the TB Referral Centre. The median turnaround time from sending specimens to receipt of results at the TB Referral Centre was 119 days. Conclusion: Less than 10% of retreatment TB patients in mid-West Nepal had CDST results recorded, leading to the underdiagnosis of MDR-TB in the region. Urgent solutions are needed to rectify this problem. PMID:26423764

40 CFR 160.105 - Test, control, and reference substance characterization.

Code of Federal Regulations, 2014 CFR

2014-07-01

... concomitantly according to written standard operating procedures, which provide for periodic analysis of each...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.105 Test...

40 CFR 160.105 - Test, control, and reference substance characterization.

Code of Federal Regulations, 2010 CFR

2010-07-01

... concomitantly according to written standard operating procedures, which provide for periodic analysis of each...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.105 Test...

40 CFR 160.105 - Test, control, and reference substance characterization.

Code of Federal Regulations, 2011 CFR

2011-07-01

... concomitantly according to written standard operating procedures, which provide for periodic analysis of each...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.105 Test...

40 CFR 160.105 - Test, control, and reference substance characterization.

Code of Federal Regulations, 2012 CFR

2012-07-01

... concomitantly according to written standard operating procedures, which provide for periodic analysis of each...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.105 Test...

40 CFR 160.105 - Test, control, and reference substance characterization.

Code of Federal Regulations, 2013 CFR

2013-07-01

... concomitantly according to written standard operating procedures, which provide for periodic analysis of each...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.105 Test...

Characterization of X-ray fields at the center for devices and radiological health

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

Cerra, F.

This talk summarizes the process undertaken by the Center for Devices and Radiological Health (CDRH) for establishing reference x-ray fields in its accredited calibration laboratory. The main considerations and their effects on the calibration parameters are discussed. The characterization of fields may be broken down into two parts: (1) the initial setup of the calibration beam spectra and (2) the ongoing measurements and controls which ensure consistency of the reference fields. The methods employed by CDRH for both these stages and underlying considerations are presented. Uncertainties associated with the various parameters are discussed. Finally, the laboratory`s performance, as evidenced bymore » ongoing measurement quality assurance results, is reported.« less

PP165. Treatment approaches for preeclampsia: A sample from a big city of a developing country.

PubMed

De Oliveira, L; Rocha, R M; Da Silva, L L; Rosas, C F; Korkes, H; Sass, N

2012-07-01

Preeclampsia is a major cause of maternal morbidity and mortality worldwide, mainly in developing countries. Here we show an example of how is the clinical condition of these patients when they are referred from first care units to a tertiary care teaching maternity in the city of São Paulo, Brazil. To evaluate how has been the approach for preeclamptic women in a big city of Brazil, an example of developing country. This is a retrospective study that evaluated 41 patients that were referred to our hospital from August 2010 to December 2011. In most of the cases patients were referred due to elevations in blood pressure. The diagnosis of preeclampsia was based on the ISSHP recommendations. The diagnosis of severe preeclampsia was based either on clinical symptoms and/or laboratory parameters. Fetal distress was defined when Doppler velocimetry assessment demonstrated abnormal parameters (centralization with abnormal diastolic blood flow at umbilical arteries). Severe preeclampsia was diagnosed in 26 cases (63.4%) and 34 patients were treated with magnesium sulfate (82.9%). One case of eclampsia (2.4%) and five cases of "Abruptio Placentae" (12.1%) were registered. Fetal distress was diagnosed at the moment of admission in 13 cases (31.7%) and two of these fetuses ended in stillbirth (4.8%). Neonatal death occurred in three cases (7.3%), mainly due to extreme preterm delivery. Other outcomes are reported in the following table. ICU: Intensive Care Unit. This is a good example of how has been the approach of preeclamptic women in a big city of Brazil. Our results suggest that a special concern about the moment of referring these patients to tertiary care units should be taken by doctors at first care units. Copyright © 2012. Published by Elsevier B.V.

Influence of the amount of body weight support on lower limb joints' kinematics during treadmill walking at different gait speeds: Reference data on healthy adults to define trajectories for robot assistance.

PubMed

Ferrarin, Maurizio; Rabuffetti, Marco; Geda, Elisabetta; Sirolli, Silvia; Marzegan, Alberto; Bruno, Valentina; Sacco, Katiuscia

2018-06-01

Several robotic devices have been developed for the rehabilitation of treadmill walking in patients with movement disorders due to injuries or diseases of the central nervous system. These robots induce coordinated multi-joint movements aimed at reproducing the physiological walking or stepping patterns. Control strategies developed for robotic locomotor training need a set of predefined lower limb joint angular trajectories as reference input for the control algorithm. Such trajectories are typically taken from normative database of overground unassisted walking. However, it has been demonstrated that gait speed and the amount of body weight support significantly influence joint trajectories during walking. Moreover, both the speed and the level of body weight support must be individually adjusted according to the rehabilitation phase and the residual locomotor abilities of the patient. In this work, 10 healthy participants (age range: 23-48 years) were asked to walk in movement analysis laboratory on a treadmill at five different speeds and four different levels of body weight support; besides, a trial with full body weight support, that is, with the subject suspended on air, was performed at two different cadences. The results confirm that lower limb kinematics during walking is affected by gait speed and by the amount of body weight support, and that on-air stepping is radically different from treadmill walking. Importantly, the results provide normative data in a numerical form to be used as reference trajectories for controlling robot-assisted body weight support walking training. An electronic addendum is provided to easily access to such reference data for different combinations of gait speeds and body weight support levels.

The Asian project for collaborative derivation of reference intervals: (1) strategy and major results of standardized analytes.

PubMed

Ichihara, Kiyoshi; Ceriotti, Ferruccio; Tam, Tran Huu; Sueyoshi, Shigeo; Poon, Priscilla M K; Thong, Mee Ling; Higashiuesato, Yasushi; Wang, Xuejing; Kataoka, Hiromi; Matsubara, Akemi; Shiesh, Shu-Chu; Muliaty, Dewi; Kim, Jeong-Ho; Watanabe, Masakazu; Lam, Christopher W K; Siekmann, Lothar; Lopez, Joseph B; Panteghini, Mauro

2013-07-01

A multicenter study conducted in Southeast Asia to derive reference intervals (RIs) for 72 commonly measured analytes (general chemistry, inflammatory markers, hormones, etc.) featured centralized measurement to clearly detect regionality in test results. The results of 31 standardized analytes are reported, with the remaining analytes presented in the next report. The study included 63 clinical laboratories from South Korea, China, Vietnam, Malaysia, Indonesia, and seven areas in Japan. A total of 3541 healthy individuals aged 20-65 years (Japan 2082, others 1459) were recruited mostly from hospital workers using a well-defined common protocol. All serum specimens were transported to Tokyo at -80°C and collectively measured using reagents from four manufacturers. Three-level nested ANOVA was used to quantitate variation (SD) of test results due to region, sex, and age. A ratio of SD for a given factor over residual SD (representing net between-individual variations) (SDR) exceeding 0.3 was considered significant. Traceability of RIs was ensured by recalibration using value-assigned reference materials. RIs were derived parametrically. SDRs for sex and age were significant for 19 and 16 analytes, respectively. Regional difference was significant for 11 analytes, including high density lipoprotein (HDL)-cholesterol and inflammatory markers. However, when the data were limited to those from Japan, regionality was not observed in any of the analytes. Accordingly, RIs were derived with or without partition by sex and region. RIs applicable to a wide area in Asia were established for the majority of analytes with traceability to reference measuring systems, whereas regional partitioning was required for RIs of the other analytes.

Markers of Renal Function and Injury

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

Ragan, Harvey A.; Weller, Richard E.

1999-04-15

Designed to aid the laboratory animal veterinarian, researcher, or toxicologist in the proper evaluation of organ function, this updated and revised edition provides the only comprehensive reference of the clinical chemistry of laboratory animals. With contributions from recognized experts in the field, new chapters are included that focus on the pig and the ferret, while many chapters have been rewritten. Expanded coverage was given to urine chemistry, hormones, including melatonin, and the control mechanisms of analytes. Reference values are given in both conventional and S.I. units.

The National Ballistics Imaging Comparison (NBIC) project.

PubMed

Song, J; Vorburger, T V; Ballou, S; Thompson, R M; Yen, J; Renegar, T B; Zheng, A; Silver, R M; Ols, M

2012-03-10

In response to the guidelines issued by the American Society of Crime Laboratory Directors/Laboratory Accreditation Board (ASCLD/LAB-International) to establish traceability and quality assurance in U.S. crime laboratories, a NIST/ATF joint project entitled National Ballistics Imaging Comparison (NBIC) was initialized in 2008. The NBIC project aims to establish a National Traceability and Quality System for ballistics identifications in crime laboratories within the National Integrated Ballistics Information Network (NIBIN) of the U.S. NIST Standard Reference Material (SRM) 2460 bullets and 2461 cartridge cases are used as reference standards. 19 ballistics examiners from 13 U.S. crime laboratories participated in this project. They each performed 24 periodic image acquisitions and correlations of the SRM bullets and cartridge cases over the course of a year, but one examiner only participated in Phase 1 tests of SRM cartridge case. The correlation scores were collected by NIST for statistical analyses, from which control charts and control limits were developed for the proposed Quality System and for promoting future assessments and accreditations for firearm evidence in U.S. forensic laboratories in accordance with the ISO 17025 Standard. Published by Elsevier Ireland Ltd.

Burkholderia pseudomallei: Challenges for the Clinical Microbiology Laboratory.

PubMed

Hemarajata, Peera; Baghdadi, Jonathan D; Hoffman, Risa; Humphries, Romney M

2016-12-01

Melioidosis is a potentially fatal infection caused by the bacterium Burkholderia pseudomallei Clinical diagnosis of melioidosis can be challenging since there is no pathognomonic clinical syndrome, and the organism is often misidentified by methods used routinely in clinical laboratories. Although the disease is more prevalent in Thailand and northern Australia, sporadic cases may be encountered in areas where it is not endemic, including the United States. Since the organism is considered a tier 1 select agent according to the Centers for Disease Control and Prevention and the U.S. Department of Agriculture Animal and Plant Health Inspection Service, clinical laboratories must be proficient at rapidly recognizing isolates suspicious for B. pseudomallei, be able to safely perform necessary rule-out tests, and to refer suspect isolates to Laboratory Response Network reference laboratories. In this minireview, we report a case of melioidosis encountered at our institution and discuss the laboratory challenges encountered when dealing with clinical isolates suspicious for B. pseudomallei or clinical specimens from suspected melioidosis cases. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

Student Reciprocal Peer Teaching as a Method for Active Learning: An Experience in an Electrotechnical Laboratory

NASA Astrophysics Data System (ADS)

Muñoz-García, Miguel A.; Moreda, Guillermo P.; Hernández-Sánchez, Natalia; Valiño, Vanesa

2013-10-01

Active learning is one of the most efficient mechanisms for learning, according to the psychology of learning. When students act as teachers for other students, the communication is more fluent and knowledge is transferred easier than in a traditional classroom. This teaching method is referred to in the literature as reciprocal peer teaching. In this study, the method is applied to laboratory sessions of a higher education institution course, and the students who act as teachers are referred to as "laboratory monitors." A particular way to select the monitors and its impact in the final marks is proposed. A total of 181 students participated in the experiment, experiences with laboratory monitors are discussed, and methods for motivating and training laboratory monitors and regular students are proposed. The types of laboratory sessions that can be led by classmates are discussed. This work is related to the changes in teaching methods in the Spanish higher education system, prompted by the Bologna Process for the construction of the European Higher Education Area

Standardization for oxygen isotope ratio measurement - still an unsolved problem.

PubMed

Kornexl; Werner; Gehre

1999-07-01

Numerous organic and inorganic laboratory standards were gathered from nine European and North American laboratories and were analyzed for their delta(18)O values with a new on-line high temperature pyrolysis system that was calibrated using Vienna standard mean ocean water (VSMOW) and standard light Antartic precipitation (SLAP) internationally distributed reference water samples. Especially for organic materials, discrepancies between reported and measured values were high, ranging up to 2 per thousand. The reasons for these discrepancies are discussed and the need for an exact and reliable calibration of existing reference materials, as well as for the establishment of additional organic and inorganic reference materials is stressed. Copyright 1999 John Wiley & Sons, Ltd.

Linking results of key and supplementary comparisons of AC/DC voltage transfer references

NASA Astrophysics Data System (ADS)

Velychko, Oleh

2018-04-01

A regional key comparison (KC) COOMET.EM-K6.a and a supplementary comparison (SC) COOMET.EM-S1 of AC/DC voltage transfer references were conducted between participating laboratories from the Eurasian region. Measurements were made over the period 2004-2014. The results showed good agreement between all but one of the participating laboratories. The proposed procedure of linking results of key and SCs of regional metrology organization of AC/DC voltage transfer references is presented. Linking results is realized for COOMET.EM-K6.a and CCEM-K6.a KCs, and for COOMET.EM-K6.a KC and COOMET.EM-S1 SC.

Mobile Technology Education Laboratory: An Alternative for Elementary Technology Education in a Restructuring School District in Central California.

ERIC Educational Resources Information Center

Britton, Steven M.

The purpose of this study was to explore what options exist for a school district that has chosen to implement or reinforce an elementary technology education program. The option selected was a mobile technology education laboratory. A mobile laboratory can offer the advantages of financial flexibility, currentness, ability to serve a large…

[Reference values for the blood coagulation tests in Mexico: usefulness of the pooled plasma from blood donors].

PubMed

Calzada-Contreras, Adriana; Moreno-Hernández, Manuel; Castillo-Torres, Noemi Patricia; Souto-Rosillo, Guadalupe; Hernández-Juárez, Jesús; Ricardo-Moreno, María Tania; Sánchez-Fernández, Maria Guadalupe de Jesús; García-González, América; Majluf-Cruz, Abraham

2012-01-01

The blood coagulation system maintains the blood in a liquid state and bleeding and thrombosis are the manifestations of its malfunction. Blood coagulation laboratory evaluates the physiology of this system. To establish both, the reference values for several tests performed at the blood coagulation laboratory as well as the utility of the pooled plasma to perform these assays. MATERIAL AND: In this descriptive, cross-sectional, randomized study, we collected plasma from Mexican Mestizos. Each pooled plasma was prepared with the plasma from at least 20 blood donors. We performed screening and special tests and the Levey-Jennings graphs were built and interpreted after each pass. Results of the tests were analyzed and their distribution was established using the Kolmogorov-Smirnov test. To establish the reference values we used 95% confidence intervals. We collected 72 pooled plasmas. The distribution for PT, APTT, and TT tests was abnormal. Although the PT test showed a bimodal distribution it was normal for factor VII. The reference values for the hemostatic, anticoagulant, and fibrinolytic factors were different from those suggested by the manufacturers. We established the reference values for the blood coagulation tests in the adult Mexican population. We have shown that the pooled plasma must be used for the screening tests. We suggest that each clinical laboratory should establish its own reference values (at least for the screening tests). To reach this objective, we encourage the use of the pooled plasma.

Subacute combined degeneration

MedlinePlus

... SCD Images Central nervous system and peripheral nervous system Central nervous system References Pytel P, Anthony DC. Peripheral nerves and ... chap 27. So YT. Deficiency diseases of the nervous system. In: Daroff RB, Jankovic J, Mazziotta JC, Pomeroy ...

Empirical insights and considerations for the OBT inter-laboratory comparison of environmental samples.

PubMed

Kim, Sang-Bog; Roche, Jennifer

2013-08-01

Organically bound tritium (OBT) is an important tritium species that can be measured in most environmental samples, but has only recently been recognized as a species of tritium in these samples. Currently, OBT is not routinely measured by environmental monitoring laboratories around the world. There are no certified reference materials (CRMs) for environmental samples. Thus, quality assurance (QA), or verification of the accuracy of the OBT measurement, is not possible. Alternatively, quality control (QC), or verification of the precision of the OBT measurement, can be achieved. In the past, there have been differences in OBT analysis results between environmental laboratories. A possible reason for the discrepancies may be differences in analytical methods. Therefore, inter-laboratory OBT comparisons among the environmental laboratories are important and would provide a good opportunity for adopting a reference OBT analytical procedure. Due to the analytical issues, only limited information is available on OBT measurement. Previously conducted OBT inter-laboratory practices are reviewed and the findings are described. Based on our experiences, a few considerations were suggested for the international OBT inter-laboratory comparison exercise to be completed in the near future. Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.

46 CFR 169.115 - Incorporation by reference.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Exhaust Systems for Propulsion and Auxiliary Engines” (1973) H-24.9 (g) and (h)—“Fuel Strainers and Fuel...) Underwriters Laboratories, Inc. (UL), 12 Laboratory Drive, Research Triangle Park, NC 27709-3995 UL 19-78...

Whether a Building or a State of Mind, the Central Office Must Evolve

ERIC Educational Resources Information Center

Mizell, Hayes

2010-01-01

The central office is both a physical place and a state of mind. In some school systems, the central office is a separate building located away from schools. In other communities, the office is housed in one of the school buildings. When someone mentions "central office," they may not be referring only to the building. They may also mean the tip…

Pacific Pediatric Advanced Care Initiative

DTIC Science & Technology

2009-10-01

Prepare IV ports:  Identify IV ports (UVC, Femoral venous line, other central venous lines, or PIV) for easy access to push meds or administer volume...Supply Department CVL central venous line CXR chest xray DC discontinue DI Diagnostic Imaging DIC disseminated intravascular coagulation diff...programs at KMCWC. These include the blood bank, blood utilization committee, clinical laboratories, operating room, central supply, pharmacy

Classroom Assessment for Student Learning: Impact on Elementary School Mathematics in the Central Region. Final Report. NCEE 2011-4005

ERIC Educational Resources Information Center

Randel, Bruce; Beesley, Andrea D.; Apthorp, Helen; Clark, Tedra F.; Wang, Xin; Cicchinelli, Louis F.; Williams, Jean M.

2011-01-01

This study was conducted by the Central Region Educational Laboratory (REL Central) administered by Mid-continent Research for Education and Learning to provide educators and policymakers with rigorous evidence about the potential of Classroom Assessment for Student Learning (CASL) to improve student achievement. CASL is a widely used professional…

Mortality among British Columbians testing for hepatitis C antibody.

PubMed

Yu, Amanda; Spinelli, John J; Cook, Darrel A; Buxton, Jane A; Krajden, Mel

2013-04-02

Hepatitis C virus (HCV) infection is a major preventable and treatable cause of morbidity and mortality. The ability to link population based centralized laboratory HCV testing data with administrative databases provided a unique opportunity to compare mortality between HCV seronegative and seropositive individuals. Through the use of laboratory testing patterns and results, the objective of this study was to differentiate the viral effects of mortality due to HCV infection from risk behaviours/activities that are associated with acquisition of HCV infection. Serological testing data from the British Columbia (BC) Centre for Disease Control Public Health Microbiology and Reference Laboratory from 1992-2004 were linked to the BC Vital Statistics Agency death registry. Four groups of HCV testers were defined by their HCV antibody (anti-HCV) testing patterns: single non-reactive (SNR); serial multiple tested non-reactive (MNR); reactive at initial testing (REAC); and seroconverter (SERO) (previously seronegative followed by reactive, a marker for incident infection). Standardized mortality ratios (SMRs) were calculated to compare the relative risk of all cause and disease specific mortality to that of the BC population for each serological group. Time dependent Cox proportional hazard regression was used to compare hazard ratios (HRs) among HCV serological groups. All anti-HCV testers had higher SMRs than the BC population. Referent to the SNR group, the REAC group had higher risks for liver (HR: 9.62; 95% CI=8.55-10.87) and drug related mortality (HR: 13.70; 95% CI=11.76-16.13). Compared to the REAC group, the SERO group had a lower risk for liver (HR: 0.53; 95% CI=0.24-0.99), but a higher risk for drug related mortality (HR: 1.54; 95% CI=1.12-2.05). These findings confirm that individuals who test anti-HCV positive have increased mortality related to progressive liver disease, and that a substantial proportion of the mortality is attributable to drug use and risk behaviours/activities associated with HCV acquisition. Mortality reduction in HCV infected individuals will require comprehensive prevention programming to reduce the harms due to behaviours/activities which relate to HCV acquisition, as well as HCV treatment to prevent progression of chronic liver disease.

Role of the "National Reference Centre for Genetically Modified Organisms (GMO) detection" in the official control of food and feed.

PubMed

Ciabatti, I; Marchesi, U; Froiio, A; Paternò, A; Ruggeri, M; Amaddeo, D

2005-08-01

The National Reference Centre for Genetically Modified Organisms (GMO) detection was established in 2002 within the Istituto Zooprofilattico Sperimentale Lazio e Toscana, with the aim of providing scientific and technical support to the National Health System and to the Ministry of Health within the scope of the regulation of GMO use in food and feed.The recently adopted EU legislation on GMOs (Regulation CE no. 1829/2003 and no. 1830/2003) introduced more rigorous procedures for the authorisation, labelling and analytical control of food and feed consisting, containing or derived from GMOs. The National Reference Centre, besides its institutional tasks as one of the laboratories of the Italian National Health System, collects and analyses data and results of the national official control of GMOs; carries out scientific research aimed at developing, improving, validating and harmonising detection and quantification methods, in cooperation with other scientific institutions, the Community Reference Laboratory and within the European Network of GMOs laboratories (ENGL); collaborates with the Ministry of Health in the definition of control programmes and promotes educational and training initiatives. Objectives defined for 2004-2006, activities in progress and goals already achieved are presented.

Interlaboratory Study Characterizing a Yeast Performance Standard for Benchmarking LC-MS Platform Performance*

PubMed Central

Paulovich, Amanda G.; Billheimer, Dean; Ham, Amy-Joan L.; Vega-Montoto, Lorenzo; Rudnick, Paul A.; Tabb, David L.; Wang, Pei; Blackman, Ronald K.; Bunk, David M.; Cardasis, Helene L.; Clauser, Karl R.; Kinsinger, Christopher R.; Schilling, Birgit; Tegeler, Tony J.; Variyath, Asokan Mulayath; Wang, Mu; Whiteaker, Jeffrey R.; Zimmerman, Lisa J.; Fenyo, David; Carr, Steven A.; Fisher, Susan J.; Gibson, Bradford W.; Mesri, Mehdi; Neubert, Thomas A.; Regnier, Fred E.; Rodriguez, Henry; Spiegelman, Cliff; Stein, Stephen E.; Tempst, Paul; Liebler, Daniel C.

2010-01-01

Optimal performance of LC-MS/MS platforms is critical to generating high quality proteomics data. Although individual laboratories have developed quality control samples, there is no widely available performance standard of biological complexity (and associated reference data sets) for benchmarking of platform performance for analysis of complex biological proteomes across different laboratories in the community. Individual preparations of the yeast Saccharomyces cerevisiae proteome have been used extensively by laboratories in the proteomics community to characterize LC-MS platform performance. The yeast proteome is uniquely attractive as a performance standard because it is the most extensively characterized complex biological proteome and the only one associated with several large scale studies estimating the abundance of all detectable proteins. In this study, we describe a standard operating protocol for large scale production of the yeast performance standard and offer aliquots to the community through the National Institute of Standards and Technology where the yeast proteome is under development as a certified reference material to meet the long term needs of the community. Using a series of metrics that characterize LC-MS performance, we provide a reference data set demonstrating typical performance of commonly used ion trap instrument platforms in expert laboratories; the results provide a basis for laboratories to benchmark their own performance, to improve upon current methods, and to evaluate new technologies. Additionally, we demonstrate how the yeast reference, spiked with human proteins, can be used to benchmark the power of proteomics platforms for detection of differentially expressed proteins at different levels of concentration in a complex matrix, thereby providing a metric to evaluate and minimize preanalytical and analytical variation in comparative proteomics experiments. PMID:19858499

Heparin-induced thrombocytopenia: reducing misdiagnosis via collaboration between an inpatient anticoagulation pharmacy service and hospital reference laboratory.

PubMed

Burnett, Allison E; Bowles, Harmony; Borrego, Matthew E; Montoya, Tiffany N; Garcia, David A; Mahan, Charles

2016-11-01

Misdiagnosis of heparin-induced thrombocytopenia (HIT) is common and exposes patients to high-risk therapies and potentially serious adverse events. The primary objective of this study was to evaluate the impact of collaboration between an inpatient pharmacy-driven anticoagulation management service (AMS) and hospital reference laboratory to reduce inappropriate HIT antibody testing via pharmacist intervention and use of the 4T pre-test probability score. Secondary objectives included clinical outcomes and cost-savings realized through reduced laboratory testing and decreased unnecessary treatment of HIT. This was a single center, pre-post, observational study. The hospital reference laboratory contacted the AMS when they received a blood sample for an enzyme-linked immunosorbent HIT antibody (HIT Ab). Trained pharmacists prospectively scored each HIT Ab ordered by using the 4T score with subsequent communication to physicians recommending for or against processing and reporting of lab results. Utilizing retrospective chart review and a database for all patients with a HIT Ab ordered during the study period, we compared the incidence of HIT Ab testing before and after implementation of the pharmacy-driven 4T score intervention. Our intervention significantly reduced the number of inappropriate HIT Ab tests processed (176 vs. 63, p < 0.0001), with no increase in thrombotic or hemorrhagic events. Overall incidence of suspected and confirmed HIT was <3 and <0.005 %, respectively. Overall cost savings were $75,754 (US) or 62 % per patient exposed to heparin between the pre and post intervention groups. Collaboration between inpatient pharmacy AMS and hospital reference laboratories can result in reduction of misdiagnosis of HIT and significant cost savings with similar safety.

Multi-center evaluation of the cobas® Liat® Influenza A/B & RSV assay for rapid point of care diagnosis.

PubMed

Gibson, Jane; Schechter-Perkins, Elissa M; Mitchell, Patricia; Mace, Sharon; Tian, Yu; Williams, Kemi; Luo, Robert; Yen-Lieberman, Belinda

2017-10-01

Point of Care Testing (POCT) provides the capability for rapid laboratory test results in patient care environments where a traditional clinical laboratory is not available. POCTs have shorter turn-around times (TATs), they may be performed by non-laboratory personnel, and the need for transport time is eliminated. The Food and Drug Administration (FDA) recently granted Clinical Laboratory Improvements Amendment (CLIA) waiver status to the cobas ® Influenza A/B & RSV assay, a rapid, accurate point-of-care test for Influenza and respiratory syncytial virus (RSV) performed on the Liat ® System. The performance characteristics of this test were determined though a multi-site study consisting of different point of care testing environments. Prospectively collected Nasopharyngeal (NP) swabs from 1361 patients seen at 8 primary care clinics and 4 emergency departments (EDs) and 295 retrospectively identified specimens were tested for Influenza A/B and RSV on the cobas ® Liat ® platform. Performance characteristics were determined through comparison to ProFlu+, a laboratory-based PCR test for Influenza A/B and RSV (reference test). Discordant specimens were adjudicated following bi-directional sequencing. The cobas ® Influenza A/B and RSV assay showed sensitivities of 99.6%, 99.3%, and 96.8% for Influenza A, Influenza B, and RSV, respectively as determined from percent positive agreement (PPA) following comparison to the reference test. Sequencing confirmed cobas ® Influenza A/B and RSV results in 49.2% of reference test discordant specimens, while crossing threshold data suggest increased sensitivity compared to the reference test. The cobas ® Influenza A/B and RSV assay was found to be a rapid, sensitive POCT for the detection of these viruses, and provides laboratory-quality PCR-based diagnostic results in point of care settings. Copyright © 2017 Elsevier B.V. All rights reserved.

External quality assurance of HER2 fluorescence in situ hybridisation testing: results of a UK NEQAS pilot scheme.

PubMed

Bartlett, John M S; Ibrahim, Merdol; Jasani, Bharat; Morgan, John M; Ellis, Ian; Kay, Elaine; Magee, Hilary; Barnett, Sarah; Miller, Keith

2007-07-01

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. FISH was performed in 6 reference and 31 participating laboratories using a cell line panel with known HER2 status. 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. 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".

Preparation and Certification of Two New Bulk Welding Fume Reference Materials for Use in Laboratories Undertaking Analysis of Occupational Hygiene Samples

PubMed Central

Butler, Owen; Musgrove, Darren; Stacey, Peter

2014-01-01

Workers can be exposed to fume, arising from welding activities, which contain toxic metals and metalloids. Occupational hygienists need to assess and ultimately minimize such exposure risks. The monitoring of the concentration of particles in workplace air is one assessment approach whereby fume, from representative welding activities, is sampled onto a filter and returned to a laboratory for analysis. Inductively coupled plasma-atomic emission spectrometry and inductively coupled plasma-mass spectrometry are generally employed as instrumental techniques of choice for the analysis of such filter samples. An inherent difficulty, however, with inductively coupled plasma-based analytical techniques is that they typically require a sample to be presented for analysis in the form of a solution. The efficiency of the required dissolution step relies heavily upon the skill and experience of the analyst involved. A useful tool in assessing the efficacy of this dissolution step would be the availability and subsequent analysis of welding fume reference materials with stated elemental concentrations and matrices that match as closely as possible the matrix composition of welding fume samples submitted to laboratories for analysis. This article describes work undertaken at the Health and Safety Laboratory to prepare and certify two new bulk welding fume reference materials that can be routinely used by analysts to assess the performance of the digestion procedures they employ in their laboratories. PMID:24499055

Preparation and certification of two new bulk welding fume reference materials for use in laboratories undertaking analysis of occupational hygiene samples.

PubMed

Butler, Owen; Musgrove, Darren; Stacey, Peter

2014-01-01

Workers can be exposed to fume, arising from welding activities, which contain toxic metals and metalloids. Occupational hygienists need to assess and ultimately minimize such exposure risks. The monitoring of the concentration of particles in workplace air is one assessment approach whereby fume, from representative welding activities, is sampled onto a filter and returned to a laboratory for analysis. Inductively coupled plasma-atomic emission spectrometry and inductively coupled plasma-mass spectrometry are generally employed as instrumental techniques of choice for the analysis of such filter samples. An inherent difficulty, however, with inductively coupled plasma-based analytical techniques is that they typically require a sample to be presented for analysis in the form of a solution. The efficiency of the required dissolution step relies heavily upon the skill and experience of the analyst involved. A useful tool in assessing the efficacy of this dissolution step would be the availability and subsequent analysis of welding fume reference materials with stated elemental concentrations and matrices that match as closely as possible the matrix composition of welding fume samples submitted to laboratories for analysis. This article describes work undertaken at the Health and Safety Laboratory to prepare and certify two new bulk welding fume reference materials that can be routinely used by analysts to assess the performance of the digestion procedures they employ in their laboratories.

Reference earth orbital research and applications investigations (blue book). Volume 3: Physics

NASA Technical Reports Server (NTRS)

1971-01-01

The definition of physics experiments to be conducted aboard the space station is presented. The four functional program elements are: (1) space physics research laboratory, (2) plasma physics and environmental perturbation laboratory, (3) cosmic ray physics laboratory, and (4) physics and chemistry laboratory. The experiments to be conducted by each facility are defined and the crew member requirements to accomplish the experiments are presented.

Establishing a China malaria diagnosis reference laboratory network for malaria elimination.

PubMed

Yin, Jian-hai; Yan, He; Huang, Fang; Li, Mei; Xiao, Hui-hui; Zhou, Shui-sen; Xia, Zhi-gui

2015-01-28

In China, the prevalence of malaria has reduced dramatically due to the elimination programme. The continued success of the programme will depend upon the accurate diagnosis of the disease in the laboratory. The basic requirements for this are a reliable malaria diagnosis laboratory network and quality management system to support case verification and source tracking. The baseline information of provincial malaria laboratories in the China malaria diagnosis reference laboratory network was collected and analysed, and a quality-assurance activity was carried out to assess their accuracies in malaria diagnosis by microscopy using WHO standards and PCR. By the end of 2013, nineteen of 24 provincial laboratories have been included in the network. In the study, a total of 168 staff were registered and there was no bias in their age, gender, education level, and position. Generally Plasmodium species were identified with great accuracy by microscopy and PCR. However, Plasmodium ovale was likely to be misdiagnosed as Plasmodium vivax by microscopy. China has established a laboratory network for primary malaria diagnosis which will cover a larger area. Currently, Plasmodium species can be identified fairly accurately by microscopy and PCR. However, laboratory staff need additional trainings on accurate identification of P. ovale microscopically and good performance of PCR operations.

KEY COMPARISON: Final report of the SIM 60Co absorbed-dose-to-water comparison SIM.RI(I)-K4

NASA Astrophysics Data System (ADS)

Ross, C. K.; Shortt, K. R.; Saravi, M.; Meghzifene, A.; Tovar, V. M.; Barbosa, R. A.; da Silva, C. N.; Carrizales, L.; Seltzer, S. M.

2008-01-01

Transfer chambers were used to compare the standards for 60Co absorbed dose to water maintained by seven laboratories. Six of the laboratories were members of the Sistema Interamericano de Metrología (SIM) regional metrology organization while the seventh was the International Atomic Energy Agency (IAEA) laboratory in Vienna. The National Research Council (NRC) acted as the pilot laboratory for the comparison. Because of the participation of laboratories holding primary standards, the comparison results could be linked to the key comparison reference value maintained by the Bureau International des Poids et Mesures (BIPM). The results for all laboratories were within the expanded uncertainty (two standard deviations) of the reference value. The estimated relative standard uncertainty on the comparison between any pair of laboratories ranged from 0.6% to 1.4%. The largest discrepancy between any two laboratories was 1.3%. Main text. To reach the main text of this paper, click on Final Report. Note that this text is that which appears in Appendix B of the BIPM key comparison database kcdb.bipm.org/. The final report has been peer-reviewed and approved for publication by the CCRI Section I, according to the provisions of the CIPM Mutual Recognition Arrangement (MRA).

KEY COMPARISON: Final report of the SIM 60Co air-kerma comparison SIM.RI(I)-K1

NASA Astrophysics Data System (ADS)

Ross, C. K.; Shortt, K. R.; Saravi, M.; Meghzifene, A.; Tovar, V. M.; Barbosa, R. A.; da Silva, C. N.; Carrizales, L.; Seltzer, S. M.

2008-01-01

Transfer chambers were used to compare the standards for 60Co air kerma maintained by seven laboratories. Six of the laboratories are members of the Sistema Interamericano de Metrología (SIM) regional metrology organization while the seventh is the International Atomic Energy Agency (IAEA) laboratory in Vienna. The National Research Council (NRC) acted as the pilot laboratory for the comparison. Because of the participation of laboratories holding primary standards, the comparison results could be linked to the key comparison reference value maintained by the Bureau International des Poids et Mesures (BIPM). The results for all laboratories were within the expanded uncertainty (two standard deviations) of the reference value. The estimated relative standard uncertainty of the comparison between any pair of laboratories ranged from 0.5% to 1.0%. The largest discrepancy between any two laboratories was 1.0%. Main text. To reach the main text of this paper, click on Final Report. Note that this text is that which appears in Appendix B of the BIPM key comparison database kcdb.bipm.org/. The final report has been peer-reviewed and approved for publication by the CCRI Section I, according to the provisions of the CIPM Mutual Recognition Arrangement (MRA).

Centralization and Decentralization: An International Viewpoint on an American Dilemma. A Special CASEA Report.

ERIC Educational Resources Information Center

Walker, William G.

This report outlines the history of the centralization-decentralization dilemma in the goverance of organizations, discusses two types of centralization-decentralization continua, and suggests further research. The first type of continuum discussed -- the traditional American -- refers to decisionmaking in the areas of public debate and partisan…

The Central Hardwood Forest: its boundaries and physiographic provinces

Treesearch

James S. Fralish

2003-01-01

The Central Hardwood Forest (CHF) refers to the area where deciduous hardwood species overwhelmingly, but not exclusively, dominate the stands and cover types that occur as repeating units across the landscape. Transition zones where Central Hardwood species mix with species from adjacent regions identify boundaries of the region. These regions are the Northern...

The Central Hardwood Forest: Its Boundaries and Physiographic Provinces

Treesearch

James S. Fralish

2003-01-01

The Central Hardwood Forest (CHF) refers to the area where deciduous hardwood species overwhelmingly, but not exclusively, dominate the stands and cover types that occur as repeating units across the landscape. Transition zones where Central Hardwood species mix with species from adjacent regions identify boundaries of the region. These regions are the Northern...

Standardization of glycohemoglobin results and reference values in whole blood studied in 103 laboratories using 20 methods.

PubMed

Weykamp, C W; Penders, T J; Miedema, K; Muskiet, F A; van der Slik, W

1995-01-01

We investigated the effect of calibration with lyophilized calibrators on whole-blood glycohemoglobin (glyHb) results. One hundred three laboratories, using 20 different methods, determined glyHb in two lyophilized calibrators and two whole-blood samples. For whole-blood samples with low (5%) and high (9%) glyHb percentages, respectively, calibration decreased overall interlaboratory variation (CV) from 16% to 9% and from 11% to 6% and decreased intermethod variation from 14% to 6% and from 12% to 5%. Forty-seven laboratories, using 14 different methods, determined mean glyHb percentages in self-selected groups of 10 nondiabetic volunteers each. With calibration their overall mean (2SD) was 5.0% (0.5%), very close to the 5.0% (0.3%) derived from the reference method used in the Diabetes Control and Complications Trial. In both experiments the Abbott IMx and Vision showed deviating results. We conclude that, irrespective of the analytical method used, calibration enables standardization of glyHb results, reference values, and interpretation criteria.

Role of Sample Processing Strategies at the European Union National Reference Laboratories (NRLs) Concerning the Analysis of Pesticide Residues.

PubMed

Hajeb, Parvaneh; Herrmann, Susan S; Poulsen, Mette E

2017-07-19

The guidance document SANTE 11945/2015 recommends that cereal samples be milled to a particle size preferably smaller than 1.0 mm and that extensive heating of the samples should be avoided. The aim of the present study was therefore to investigate the differences in milling procedures, obtained particle size distributions, and the resulting pesticide residue recovery when cereal samples were milled at the European Union National Reference Laboratories (NRLs) with their routine milling procedures. A total of 23 NRLs participated in the study. The oat and rye samples milled by each NRL were sent to the European Union Reference Laboratory on Cereals and Feedingstuff (EURL) for the determination of the particle size distribution and pesticide residue recovery. The results showed that the NRLs used several different brands and types of mills. Large variations in the particle size distributions and pesticide extraction efficiencies were observed even between samples milled by the same type of mill.

Creatine and guanidinoacetate reference values in a French population.

PubMed

Joncquel-Chevalier Curt, Marie; Cheillan, David; Briand, Gilbert; Salomons, Gajja S; Mention-Mulliez, Karine; Dobbelaere, Dries; Cuisset, Jean-Marie; Lion-François, Laurence; Des Portes, Vincent; Chabli, Allel; Valayannopoulos, Vassili; Benoist, Jean-François; Pinard, Jean-Marc; Simard, Gilles; Douay, Olivier; Deiva, Kumaran; Tardieu, Marc; Afenjar, Alexandra; Héron, Delphine; Rivier, François; Chabrol, Brigitte; Prieur, Fabienne; Cartault, François; Pitelet, Gaëlle; Goldenberg, Alice; Bekri, Soumeya; Gerard, Marion; Delorme, Richard; Porchet, Nicole; Vianey-Saban, Christine; Vamecq, Joseph

2013-11-01

Creatine and guanidinoacetate are biomarkers of creatine metabolism. Their assays in body fluids may be used for detecting patients with primary creatine deficiency disorders (PCDD), a class of inherited diseases. Their laboratory values in blood and urine may vary with age, requiring that reference normal values are given within the age range. Despite the long known role of creatine for muscle physiology, muscle signs are not necessarily the major complaint expressed by PCDD patients. These disorders drastically affect brain function inducing, in patients, intellectual disability, autistic behavior and other neurological signs (delays in speech and language, epilepsy, ataxia, dystonia and choreoathetosis), being a common feature the drop in brain creatine content. For this reason, screening of PCDD patients has been repeatedly carried out in populations with neurological signs. This report is aimed at providing reference laboratory values and related age ranges found for a large scale population of patients with neurological signs (more than 6 thousand patients) previously serving as a background population for screening French patients with PCDD. These reference laboratory values and age ranges compare rather favorably with literature values for healthy populations. Some differences are also observed, and female participants are discriminated from male participants as regards to urine but not blood values including creatine on creatinine ratio and guanidinoacetate on creatinine ratio values. Such gender differences were previously observed in healthy populations; they might be explained by literature differential effects of testosterone and estrogen in adolescents and adults, and by estrogen effects in prepubertal age on SLC6A8 function. Finally, though they were acquired on a population with neurological signs, the present data might reasonably serve as reference laboratory values in any future medical study exploring abnormalities of creatine metabolism and transport. © 2013 Elsevier Inc. All rights reserved.

Dense rain forest in the La Selva region of Costa Rica

NASA Image and Video Library

2004-03-05

Dense rain forest in the La Selva region of Costa Rica. AirSAR 2004 Mesoamerica is a three-week expedition by an international team of scientists that uses an all-weather imaging tool, called the Airborne Synthetic Aperture Radar (AirSAR) which is located onboard NASA's DC-8 airborne laboratory. Scientists from many parts of the world including NASA's Jet Propulsion Laboratory are combining ground research done in several areas in Central America with NASA's AirSAR technology to improve and expand on the quality of research they are able to conduct. The radar, developed by NASA's Jet Propulsion Laboratory, can penetrate clouds and also collect data at night. Its high-resolution sensors operate at multiple wavelengths and modes, allowing AirSAR to see beneath treetops, through thin sand, and dry snow pack. AirSAR's 2004 campaign is a collaboration of many U.S. and Central American institutions and scientists, including NASA; the National Science Foundation; the Smithsonian Institution; National Geographic; Conservation International; the Organization of Tropical Studies; the Central American Commission for Environment and Development; and the Inter-American Development Bank.

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

Interior. Storage room for glassware and reference room with frequentlyused ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

Interior. Storage room for glassware and reference room with frequently-used chemistry and chemical engineering texts. - Thomas A. Edison Laboratories, Building No. 2, Main Street & Lakeside Avenue, West Orange, Essex County, NJ

Electron gun for a multiple beam klystron with magnetic compression of the electron beams

DOEpatents

Ives, R. Lawrence; Tran, Hien T; Bui, Thuc; Attarian, Adam; Tallis, William; David, John; Forstall, Virginia; Andujar, Cynthia; Blach, Noah T; Brown, David B; Gadson, Sean E; Kiley, Erin M; Read, Michael

2013-10-01

A multi-beam electron gun provides a plurality N of cathode assemblies comprising a cathode, anode, and focus electrode, each cathode assembly having a local cathode axis and also a central cathode point defined by the intersection of the local cathode axis with the emitting surface of the cathode. Each cathode is arranged with its central point positioned in a plane orthogonal to a device central axis, with each cathode central point an equal distance from the device axis and with an included angle of 360/N between each cathode central point. The local axis of each cathode has a cathode divergence angle with respect to the central axis which is set such that the diverging magnetic field from a solenoidal coil is less than 5 degrees with respect to the projection of the local cathode axis onto a cathode reference plane formed by the device axis and the central cathode point, and the local axis of each cathode is also set such that the angle formed between the cathode reference plane and the local cathode axis results in minimum spiraling in the path of the electron beams in a homogenous magnetic field region of the solenoidal field generator.

Genetics Home Reference: lymphedema-distichiasis syndrome

MedlinePlus

... on PubMed or Free article on PubMed Central Erickson RP, Dagenais SL, Caulder MS, Downs CA, Herman ... article on PubMed Central Fang J, Dagenais SL, Erickson RP, Arlt MF, Glynn MW, Gorski JL, Seaver ...

Reference field specification and preliminary beam selection strategy for accelerator-based GCR simulation

NASA Astrophysics Data System (ADS)

Slaba, Tony C.; Blattnig, Steve R.; Norbury, John W.; Rusek, Adam; La Tessa, Chiara

2016-02-01

The galactic cosmic ray (GCR) simulator at the NASA Space Radiation Laboratory (NSRL) is intended to deliver the broad spectrum of particles and energies encountered in deep space to biological targets in a controlled laboratory setting. In this work, certain aspects of simulating the GCR environment in the laboratory are discussed. Reference field specification and beam selection strategies at NSRL are the main focus, but the analysis presented herein may be modified for other facilities and possible biological considerations. First, comparisons are made between direct simulation of the external, free space GCR field and simulation of the induced tissue field behind shielding. It is found that upper energy constraints at NSRL limit the ability to simulate the external, free space field directly (i.e. shielding placed in the beam line in front of a biological target and exposed to a free space spectrum). Second, variation in the induced tissue field associated with shielding configuration and solar activity is addressed. It is found that the observed variation is likely within the uncertainty associated with representing any GCR reference field with discrete ion beams in the laboratory, given current facility constraints. A single reference field for deep space missions is subsequently identified. Third, a preliminary approach for selecting beams at NSRL to simulate the designated reference field is presented. This approach is not a final design for the GCR simulator, but rather a single step within a broader design strategy. It is shown that the beam selection methodology is tied directly to the reference environment, allows facility constraints to be incorporated, and may be adjusted to account for additional constraints imposed by biological or animal care considerations. The major biology questions are not addressed herein but are discussed in a companion paper published in the present issue of this journal. Drawbacks of the proposed methodology are discussed and weighed against alternative simulation strategies.

Mini-Special Issue: Taking Practical Work Beyond the Laboratory.

ERIC Educational Resources Information Center

Hodson, Derek

1998-01-01

Reviews the traditional definition of practical work in science, offers a different definition of it, and points out that practical work is not always laboratory based. Discusses the logistics of coordinating fieldwork. Contains 17 references. (DDR)

Chemical Analysis of Soils: An Environmental Chemistry Laboratory for Undergraduate Science Majors.

ERIC Educational Resources Information Center

Willey, Joan D.; Avery, G. Brooks, Jr.; Manock, John J.; Skrabal, Stephen A.; Stehman, Charles F.

1999-01-01

Describes a laboratory exercise for undergraduate science students in which they evaluate soil samples for various parameters related to suitability for crop production and capability for retention of contaminants. (Contains 18 references.) (WRM)

Restored agricultural wetlands in Central Iowa: habitat quality and amphibian response

USGS Publications Warehouse

Reeves, Rebecca A.; Pierce, Clay; Smalling, Kelly L.; Klaver, Robert W.; Vandever, Mark W.; Battaglin, William A.; Muths, Erin L.

2016-01-01

Amphibians are declining throughout the United States and worldwide due, partly, to habitat loss. Conservation practices on the landscape restore wetlands to denitrify tile drainage effluent and restore ecosystem services. Understanding how water quality, hydroperiod, predation, and disease affect amphibians in restored wetlands is central to maintaining healthy amphibian populations in the region. We examined the quality of amphibian habitat in restored wetlands relative to reference wetlands by comparing species richness, developmental stress, and adult leopard frog (Lithobates pipiens) survival probabilities to a suite of environmental metrics. Although measured habitat variables differed between restored and reference wetlands, differences appeared to have sub-lethal rather than lethal effects on resident amphibian populations. There were few differences in amphibian species richness and no difference in estimated survival probabilities between wetland types. Restored wetlands had more nitrate and alkaline pH, longer hydroperiods, and were deeper, whereas reference wetlands had more amphibian chytrid fungus zoospores in water samples and resident amphibians exhibited increased developmental stress. Restored and reference wetlands are both important components of the landscape in central Iowa and maintaining a complex of fish-free wetlands with a variety of hydroperiods will likely contribute to the persistence of amphibians in this landscape.

Factitious diarrhea induced by stimulant laxatives: accuracy of diagnosis by a clinical reference laboratory using thin layer chromatography.

PubMed

Shelton, Joseph H; Santa Ana, Carol A; Thompson, Donald R; Emmett, Michael; Fordtran, John S

2007-01-01

Surreptitious ingestion of laxatives can lead to serious factitious diseases that are difficult to diagnose. Most cases involve ingestion of bisacodyl or senna. Thin layer chromatography (TLC) of urine or stool is the only commercially available test for these laxatives. Such testing is considered highly reliable, but its accuracy in clinical practice is unknown. Our aim was to evaluate the reliability of TLC laxative testing by a clinical reference laboratory in the United States. Diarrhea was induced in healthy volunteers by ingestion of bisacodyl, senna, or a control laxative (n = 11 for each laxative group). Samples of urine and diarrheal stool were sent in blinded fashion to the clinical reference laboratory for bisacodyl and senna analysis. TLC testing for bisacodyl-induced diarrhea revealed a sensitivity of 73% and specificity of 91% when urine was tested and sensitivity and specificity of 91% and 96%, respectively, when stool was analyzed. When diarrhea was induced by senna, the TLC assay for senna failed to identify even a single urine or stool specimen as positive (zero% sensitivity). Considering the expected prevalence of surreptitious laxative abuse in patients with chronic idiopathic diarrhea (2.4%-25%, depending on the clinical setting), TLC of urine or stool for bisacodyl by this reference laboratory would often produce misleading results, and testing for senna would have no clinical value. The major problems are false-positive tests for bisacodyl and false-negative tests for senna.

Characterization of 107 Genomic DNA Reference Materials for CYP2D6, CYP2C19, CYP2C9, VKORC1, and UGT1A1

PubMed Central

Pratt, Victoria M.; Zehnbauer, Barbara; Wilson, Jean Amos; Baak, Ruth; Babic, Nikolina; Bettinotti, Maria; Buller, Arlene; Butz, Ken; Campbell, Matthew; Civalier, Chris; El-Badry, Abdalla; Farkas, Daniel H.; Lyon, Elaine; Mandal, Saptarshi; McKinney, Jason; Muralidharan, Kasinathan; Noll, LeAnne; Sander, Tara; Shabbeer, Junaid; Smith, Chingying; Telatar, Milhan; Toji, Lorraine; Vairavan, Anand; Vance, Carlos; Weck, Karen E.; Wu, Alan H.B.; Yeo, Kiang-Teck J.; Zeller, Markus; Kalman, Lisa

2010-01-01

Pharmacogenetic testing is becoming more common; however, very few quality control and other reference materials that cover alleles commonly included in such assays are currently available. To address these needs, the Centers for Disease Control and Prevention's Genetic Testing Reference Material Coordination Program, in collaboration with members of the pharmacogenetic testing community and the Coriell Cell Repositories, have characterized a panel of 107 genomic DNA reference materials for five loci (CYP2D6, CYP2C19, CYP2C9, VKORC1, and UGT1A1) that are commonly included in pharmacogenetic testing panels and proficiency testing surveys. Genomic DNA from publicly available cell lines was sent to volunteer laboratories for genotyping. Each sample was tested in three to six laboratories using a variety of commercially available or laboratory-developed platforms. The results were consistent among laboratories, with differences in allele assignments largely related to the manufacturer's assay design and variable nomenclature, especially for CYP2D6. The alleles included in the assay platforms varied, but most were identified in the set of 107 DNA samples. Nine additional pharmacogenetic loci (CYP4F2, EPHX1, ABCB1, HLAB, KIF6, CYP3A4, CYP3A5, TPMT, and DPD) were also tested. These samples are publicly available from Coriell and will be useful for quality assurance, proficiency testing, test development, and research. PMID:20889555

Internal quality control indicators of cervical cytopathology exams performed in laboratories monitored by the External Quality Control Laboratory.

PubMed

Ázara, Cinara Zago Silveira; Manrique, Edna Joana Cláudio; Tavares, Suelene Brito do Nascimento; de Souza, Nadja Lindany Alves; Amaral, Rita Goreti

2014-09-01

To evaluate the impact of continued education provided by an external quality control laboratory on the indicators of internal quality control of cytopathology exams. The internal quality assurance indicators for cytopathology exams from 12 laboratories monitored by the External Quality Control Laboratory were evaluated. Overall, 185,194 exams were included, 98,133 of which referred to the period preceding implementation of a continued education program, while 87,061 referred to the period following this intervention. Data were obtained from the Cervical Cancer Database of the Brazilian National Health Service. Following implementation of the continued education program, the positivity index (PI) remained within recommended limits in four laboratories. In another four laboratories, the PI progressed from below the limits to within the recommended standards. In one laboratory, the PI remained low, in two laboratories, it remained very low, and in one, it increased from very low to low. The percentage of exams compatible with a high-grade squamous intraepithelial lesion (HSIL) remained within the recommended limits in five laboratories, while in three laboratories it progressed from below the recommended levels to >0.4% of the total number of satisfactory exams, and in four laboratories it remained below the standard limit. Both the percentage of atypical squamous cells of undetermined significance (ASC-US) in relation to abnormal exams, and the ratio between ASC-US and intraepithelial lesions remained within recommended levels in all the laboratories investigated. An improvement was found in the indicators represented by the positivity index and the percentage of exams compatible with a high-grade squamous intraepithelial lesion, showing that the role played by the external quality control laboratory in providing continued education contributed towards improving laboratory staff skills in detecting cervical cancer precursor lesions.

The total laboratory solution: a new laboratory E-business model based on a vertical laboratory meta-network.

PubMed

Friedman, B A

2001-08-01

Major forces are now reshaping all businesses on a global basis, including the healthcare and clinical laboratory industries. One of the major forces at work is information technology (IT), which now provides the opportunity to create a new economic and business model for the clinical laboratory industry based on the creation of an integrated vertical meta-network, referred to here as the "total laboratory solution" (TLS). Participants at the most basic level of such a network would include a hospital-based laboratory, a reference laboratory, a laboratory information system/application service provider/laboratory portal vendor, an in vitro diagnostic manufacturer, and a pharmaceutical/biotechnology manufacturer. It is suggested that each of these participants would add value to the network primarily in its area of core competency. Subvariants of such a network have evolved over recent years, but a TLS comprising all or most of these participants does not exist at this time. Although the TLS, enabled by IT and closely akin to the various e-businesses that are now taking shape, offers many advantages from a theoretical perspective over the current laboratory business model, its success will depend largely on (a) market forces, (b) how the collaborative networks are organized and managed, and (c) whether the network can offer healthcare organizations higher quality testing services at lower cost. If the concept is successful, new demands will be placed on hospital-based laboratory professionals to shift the range of professional services that they offer toward clinical consulting, integration of laboratory information from multiple sources, and laboratory information management. These information management and integration tasks can only increase in complexity in the future as new genomic and proteomics testing modalities are developed and come on-line in clinical laboratories.

Pre-Employment Laboratory Training. A Guide for Coordinated Vocational-Academic Education Shop and Laboratory Instructors. Revised.

ERIC Educational Resources Information Center

East Texas State Univ., Commerce. Occupational Curriculum Lab.

This guide is designed to serve as a reference for both beginning and experienced teachers in a preemployment laboratory that is part of a coordinated vocational-academic education program. Addressed in the individual sections of the guide are the following topics: student eligibility and approved coordinated vocational-academic programs, safety…

1. VIEW IN ROOM 125, BIOASSAY LABORATORY, SHOWN IS THE ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

1. VIEW IN ROOM 125, BIOASSAY LABORATORY, SHOWN IS THE FIRST STEP IN A SIX-STEP PROCESS TO ANALYZE URINE SAMPLES FOR PLUTONIUM AND URANIUM CONTAMINATION. IN THIS STEP, NITRIC ACID IS ADDED TO SAMPLE, AND THE SAMPLE IS BOILED DOWN TO A WHITE POWDER. - Rocky Flats Plant, Health Physics Laboratory, On Central Avenue between Third & Fourth Streets, Golden, Jefferson County, CO

2. VIEW IN ROOM 111, ATOMIC ABSORPTION BERYLLIUM ANALYSIS LABORATORY. ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

2. VIEW IN ROOM 111, ATOMIC ABSORPTION BERYLLIUM ANALYSIS LABORATORY. AIR FILTERS AND SWIPES ARE DISSOLVED WITH ACIDS AND THE REMAINING RESIDUES ARE SUSPENDED IN NITRIC ACID SOLUTION. THE SOLUTION IS PROCESSED THROUGH THE ATOMIC ABSORPTION SPECTROPHOTOMETER TO DETECT THE PRESENCE AND LEVELS OF BERYLLIUM. - Rocky Flats Plant, Health Physics Laboratory, On Central Avenue between Third & Fourth Streets, Golden, Jefferson County, CO

Forest Products Laboratory : supporting the nation's armed forces with valuable wood research for 90 years

Treesearch

Christopher D. Risbrudt; Robert J. Ross; Julie J. Blankenburg; Charles A. Nelson

2007-01-01

Founded in 1910 by the U.S. Forest Service to serve as a centralized, national wood research laboratory, the USDA Forest Products Laboratory (FPL) has a long history of providing technical services to other government agencies, including those within the Defense (DoD). A recent search of FPL’s library and correspondence files revealed that approximately 10,000...

SCIENTIFIC AND RESEARCH INSTITUTIONS IN HUNGARY: I. NUCLEAR SCIENCE

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

Bacha, E.

1959-05-22

Scientific and research institutions in Hungary engaged in research in the field of nuclear science are discussed. Brief descriptions are included of the Central Research Institute of Physics, the Institute of Nuclear Research the Joliot-Curie Central Research Institute of Radiobiology, and the Physics Laboratory of the Otvos Lorand Radium and X-Ray Institute. The recently completed experimental reactor at Budapest and isotope research laboratories are described. Plans for an atomic power plant are discussed. Uranium deposits in Hungary are also discussed. A list of recent publications in the field of nuclear science is included. (C.W)

FSL_FASES

NASA Image and Video Library

2013-06-19

ISS036-E-009550 (19 June 2013) --- European Space Agency astronaut Luca Parmitano, Expedition 36 flight engineer, installs the Fundamental and Applied Studies of Emulsion Stability (FASES) experiment container into the Central Experiment Module (CEM) Lower of Fluid Science Laboratory (FSL) in the Columbus laboratory of the International Space Station.

Lab Plays Central Role in Groundbreaking National Clinical Trial in Precision Medicine | FNLCR Staging

Cancer.gov

The Molecular Characterization Laboratory at the Frederick National Laboratory for Cancer Research lies at the heart of an ambitious new approach for testing cancer drugs that will use the newest tools of precision medicine to select the best treatme

US Army Institute of Surgical Research Annual Research Progress Report for Fiscal Year 1987.

DTIC Science & Technology

1987-10-01

oases, respiratory rate, chest roentgenograms), cardiovascular (blood pressure, central venous pressure, cardiac output), and renal (urine output, urine...Monitoring includes the precordial and/or esophageal stethoscope, peripheral pulse, blood pressure, central venous pressure, Swan-Ganz catheter... central venous , peripheral venous , and Swan-Ganz (7F, American Edward Laboratories, Irvine CA) catheters and an esophageal balloon were inserted. After a 2

Clinical symptoms and laboratory findings supporting early diagnosis of Crimean-Congo hemorrhagic fever in Iran.

PubMed

Mostafavi, Ehsan; Pourhossein, Behzad; Chinikar, Sadegh

2014-07-01

Crimean-Congo hemorrhagic fever (CCHF) is a zoonotic disease, which is usually transmitted to humans by tick bites or contact with blood or other infected tissues of livestock. Patients suffering from CCHF demonstrate an extensive spectrum of clinical symptoms. As it can take considerable time from suspecting the disease in hospital until reaching a definitive diagnosis in the laboratory, understanding the clinical symptoms and laboratory findings of CCHF patients is of paramount importance for clinicians. The data were collected from patients who were referred to the Laboratory of Arboviruses and Viral Hemorrhagic Fevers at the Pasteur institute of Iran with a primary diagnosis of CCHF between 1999 and 2012 and were assessed by molecular and serologic tests. Referred patients were divided into two groups: patients with a CCHF positive result and patients with a CCHF negative result. The laboratory and clinical findings of these two groups were then compared. Two-thousand five hundred thirty-six probable cases of CCHF were referred to the laboratory, of which 871 cases (34.3%) were confirmed to be CCHF. Contact with infected humans and animals increased the CCHF infection risk (P < 0.001). A tick bite was not a risk factor. Fever; bleeding, vomiting, leucopoenia, thrombocytopenia, and increases in alanine transaminase (ALT) and aspartate transaminase (AST) levels were also indicative of CCHF infection. Accurate and speedy diagnosis of CCHF and appropriate treatment play an important role in patient survival and the application of the findings of this study can prove helpful as a key for early diagnosis. © 2014 Wiley Periodicals, Inc.

Expressing analytical performance from multi-sample evaluation in laboratory EQA.

PubMed

Thelen, Marc H M; Jansen, Rob T P; Weykamp, Cas W; Steigstra, Herman; Meijer, Ron; Cobbaert, Christa M

2017-08-28

To provide its participants with an external quality assessment system (EQAS) that can be used to check trueness, the Dutch EQAS organizer, Organization for Quality Assessment of Laboratory Diagnostics (SKML), has innovated its general chemistry scheme over the last decade by introducing fresh frozen commutable samples whose values were assigned by Joint Committee for Traceability in Laboratory Medicine (JCTLM)-listed reference laboratories using reference methods where possible. Here we present some important innovations in our feedback reports that allow participants to judge whether their trueness and imprecision meet predefined analytical performance specifications. Sigma metrics are used to calculate performance indicators named 'sigma values'. Tolerance intervals are based on both Total Error allowable (TEa) according to biological variation data and state of the art (SA) in line with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Milan consensus. The existing SKML feedback reports that express trueness as the agreement between the regression line through the results of the last 12 months and the values obtained from reference laboratories and calculate imprecision from the residuals of the regression line are now enriched with sigma values calculated from the degree to which the combination of trueness and imprecision are within tolerance limits. The information and its conclusion to a simple two-point scoring system are also graphically represented in addition to the existing difference plot. By adding sigma metrics-based performance evaluation in relation to both TEa and SA tolerance intervals to its EQAS schemes, SKML provides its participants with a powerful and actionable check on accuracy.

On factors controlling precursor slip fronts in the laboratory and their relation to slow slip events in nature

NASA Astrophysics Data System (ADS)

Selvadurai, Paul A.; Glaser, Steven D.; Parker, Jessica M.

2017-03-01

Spatial variations in frictional properties on natural faults are believed to be a factor influencing the presence of slow slip events (SSEs). This effect was tested on a laboratory frictional interface between two polymethyl methacrylate (PMMA) bodies. We studied the evolution of slip and slip rates that varied systematically based on the application of both high and low normal stress (σ0=0.8 or 0.4 MPa) and the far-field loading rate (VLP). A spontaneous, frictional rupture expanded from the central, weaker, and more compliant section of the fault that had fewer asperities. Slow rupture propagated at speeds Vslow˜0.8 to 26 mm s-1 with slip rates from 0.01 to 0.2 μm s-1, resulting in stress drops around 100 kPa. During certain nucleation sequences, the fault experienced a partial stress drop, referred to as precursor detachment fronts in tribology. Only at the higher level of normal stress did these fronts exist, and the slip and slip rates mimicked the moment and moment release rates during the 2013-2014 Boso SSE in Japan. The laboratory detachment fronts showed rupture propagation speeds Vslow/VR∈ (5 to 172) × 10-7 and stress drops ˜ 100 kPa, which both scaled to the aforementioned SSE. Distributions of asperities, measured using a pressure sensitive film, increased in complexity with additional normal stress—an increase in normal stress caused added complexity by increasing both the mean size and standard deviation of asperity distributions, and this appeared to control the presence of the detachment front.

Response to the great East Japan earthquake of 2011 and the Fukushima nuclear crisis: the case of the Laboratory Animal Research Center at Fukushima Medical University.

PubMed

Katahira, Kiyoaki; Sekiguchi, Miho

2013-01-01

A magnitude 9.0 great earthquake, the 2011 off the Pacific coast of Tohoku Earthquake, occurred on March 11, 2011, and subsequent Fukushima Daiichi Nuclear Power Station (Fukushima NPS) accidents stirred up natural radiation around the campus of Fukushima Medical University (FMU). FMU is located in Fukushima City, and is 57 km to the northwest of Fukushima NPS. Due to temporary failure of the steam boilers, the air conditioning system for the animal rooms, all autoclaves, and a cage washer could not be used at the Laboratory Animal Research Center (LARC) of FMU. The outside air temperature dropped to zero overnight, and the temperature inside the animal rooms fell to 10°C for several hours. We placed sterilized nesting materials inside all cages to encourage rodents to create nests. The main water supply was cut off for 8 days in all, while supply of steam and hot water remained unavailable for 12 days. It took 20 days to restore the air conditioning system to normal operation at the facility. We measured radiation levels in the animal rooms to confirm the safety of care staff and researchers. On April 21, May 9, and June 17, the average radiation levels at a central work table in the animal rooms with HEPA filters were 46.5, 44.4, and 43.4 cpm, respectively, which is equal to the background level of the equipment. We sincerely hope our experiences will be a useful reference regarding crisis management for many institutes having laboratory animals.

Selective testing of women based on age for genital Chlamydia trachomatis and Neisseria gonorrhoeae infection in a centralized regional microbiology laboratory.

PubMed

Church, Deirdre L; Amante, L; Semeniuk, H; Gregson, D B

2007-04-01

Calgary Laboratory Services, Alberta, Canada, provides microbiology services via a centralized laboratory to the Calgary Health Region. A selective genital Chlamydia trachomatis (CT)/Neisseria gonorrhoeae (GC) testing policy for women >35 years was implemented. The changes in physician ordering practice, the rate of detection of infections, and the test turnaround times were monitored. The volume of tests, the cost/test, and the total service costs accrued in the year before and after this policy change were compared. An immediate impact was a 30% decrease in tests performed due to the laboratory rejecting samples from older women. Subsequently, physicians' practice changed so that tests were ordered when test criteria were met. Detection rates did not change in any age group. A 27.9% decrease in the total service costs resulted in a labor reduction of 0.2 FTE. Selective testing of women >35 years with a low prevalence of CT/GC infection is clinically relevant and cost-effective.

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

PubMed

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

2016-01-01

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

Turnaround Time for Early Infant HIV Diagnosis in Rural Zambia: A Chart Review

PubMed Central

Sutcliffe, Catherine G.; van Dijk, Janneke H.; Hamangaba, Francis; Mayani, Felix; Moss, William J.

2014-01-01

Background Early infant HIV diagnosis is challenging in sub-Saharan Africa, particularly in rural areas where laboratory capacity is limited. Specimens must be transported to central laboratories for testing, leading to delays in diagnosis and initiation of antiretroviral therapy. This study was undertaken in rural Zambia to measure the turnaround time for confirmation of HIV infection and identify delays in diagnosis. Methods Chart reviews were conducted from 2010–2012 for children undergoing early infant HIV diagnosis at Macha Hospital in Zambia. Relevant dates, receipt of drugs by mother and child for the prevention of mother-to-child transmission (PMTCT), and test results were abstracted. Results 403 infants provided 476 samples for early infant diagnosis. The median age at the “6-week” and “6-month” assessments was 8.1 weeks and 7.0 months, respectively. The majority of mothers (80%) and infants (67%) received PMTCT. The median time between sample collection and arrival at the central laboratory in Lusaka was 17 days (IQR: 10, 28); arrival at the central laboratory to testing was 6 days (IQR: 5, 11); testing to return of results to the clinic was 29 days (IQR: 17, 36); arrival of results at the clinic to return of results to the caregiver was 45 days (IQR: 24, 79). The total median time from sample collection to return of results to the caregiver was 92 days (IQR: 84, 145). The proportion of HIV PCR positive samples was 12%. The total median turnaround time was shorter for HIV PCR positive as compared to negative or invalid samples (85 vs. 92 days; p = 0.08). Conclusions Delays in processing and communicating test results were identified, particularly in returning results from the central laboratory to the clinic and from the clinic to the caregiver. A more efficient process is needed so that caregivers can be provided test results more rapidly, potentially resulting in earlier treatment initiation and better outcomes for HIV-infected infants. PMID:24475214

USE OF NATURAL WATERS AS U. S. GEOLOGICAL SURVEY REFERENCE SAMPLES.

USGS Publications Warehouse

Janzer, Victor J.

1985-01-01

The U. S. Geological Survey conducts research and collects hydrologic data relating to the Nation's water resources. Seven types of natural matrix reference water samples are prepared for use in the Survey's quality assurance program. These include samples containing major constituents, trace metals, nutrients, herbicides, insecticides, trace metals in a water and suspended-sediment mixture, and precipitation (snowmelt). To prepare these reference samples, natural water is collected in plastic drums and the sediment is allowed to settle. The water is then filtered, selected constituents are added, and if necessary the water is acidified and sterilized by ultraviolet irradiation before bottling in plastic or glass. These reference samples are distributed twice yearly to more than 100 laboratories for chemical analysis. The most probable values for each constituent are determined by evaluating the data submitted by the laboratories using statistical techniques recommended by ASTM.

Calibration standards for major greenhouse gases and carbon monoxide: status and challenges.

NASA Astrophysics Data System (ADS)

Zellweger, Christoph; Mohn, Joachim; Wyss, Simon A.; Brewer, Paul; Mace, Tatiana; Nieuwenkamp, Gerard; Pearce-Hill, Ruth; Tarhan, Tanil; Walden, Jari; Emmenegger, Lukas

2017-04-01

Human influence on increasing greenhouse gas mole fractions in the atmosphere and effects on positive radiative forcing as well as observed global warming and sea level rise are well accepted [1]. For interpretation of global or continental scale greenhouse gas data, obtained from different laboratories, measurement results have to coincide within compatibility goals set by the World Meteorological Organization (WMO) [2]. Despite significant advances in measurement techniques [3], WMO compatibility goals are regularly missed, shown by round-robin experiments of standard gases and comparisons of field samples or parallel measurements. Therefore, precise and accurate calibration using standards with good long-term stability is needed to reduce uncertainties of atmospheric measurements. This is addressed by the WMO Global Atmosphere Watch Programme (GAW), where Central Calibration Laboratories (CCLs) maintain calibration scales to ensure consistency of measurements within the network to primary reference materials. Furthermore, participating GAW laboratories are supported by World Calibration Centres (WCCs) performing audits and organizing round-robin comparisons. The CCL participates regularly in comparisons with independent primary scales to assure traceability of established primary reference materials to fundamental quantities (SI) [e.g. 4]. Within the European Metrology Research Programme (EMRP) ENV52 project "Metrology for high-impact greenhouse gases" (HIGHGAS), static and dynamic primary reference gas mixtures for ambient levels of CO2, CH4, N2O and CO in air were prepared by different National Metrology Institutes (NMIs). In order to progress beyond the state of the art, research focused on improving passivation chemistry, quantification of target impurities in the air matrix, and determining the isotopic composition. These primary reference gas mixtures were compared in a round robin experiment against standards calibrated against reference gases currently used by the GAW community. We will show results of the comparison of the HIGHGAS and the WMO reference standards, and put this into the context of the WMO/GAW quality management framework. [1] IPCC, 2013: Climate Change 2013: The Physical Science Basis. Contribution of Working Group I to the Fifth Assessment Report of the Intergovernmental Panel on Climate Change [Stocker, T.F., D. Qin, G.-K. Plattner, M. Tignor, S.K. Allen, J. Boschung, A. Nauels, Y. Xia, V. Bex and P.M. Midgley (eds.)]. Cambridge University Press, Cambridge, United Kingdom and New York, NY, USA, 1535 pp. [2] WMO: 18th WMO/IAEA Meeting on Carbon Dioxide, Other Greenhouse Gases and Related Tracers Measurement Techniques (GGMT-2015), La Jolla, CA, USA, 13-17 September 2015, GAW Report No. 229, World Meteorological Organization, Geneva, Switzerland, 2016. [3] Zellweger, C., Emmenegger, L., Firdaus, M., Hatakka, J., Heimann, M., Kozlova, E., Spain, T. G., Steinbacher, M., van der Schoot, M. V., and Buchmann, B.: Assessment of recent advances in measurement techniques for atmospheric carbon dioxide and methane observations, Atmos. Meas. Tech., 9, 4737-4757, 2016. [4] Flores, E., Viallon, J., Choteau, T., Moussay, P., Wielgosz, R., Kang, N., Kim, B. M., Zalewska, E., van der Veen, A., Konopelko, L., Wu, H., Han, Q., Rhoderick, G., Guenther, F. R., Watanabe, T., Shimosaka, T., Kato, K., Hall, B., and Brewer, P.: International comparison CCQM-K82: methane in air at ambient level (1800 to 2200) nmol/mol, Metrologia, 52, 08001, 2015.

Genetics Home Reference: central precocious puberty

MedlinePlus

... girls and between ages 9 and 14 in boys, girls with central precocious puberty begin exhibiting signs before ... of puberty is even earlier than normal in girls than in boys. Boys with an MKRN3 gene mutation inherited from ...

Genetics Home Reference: congenital central hypoventilation syndrome

MedlinePlus

... M, Stevens CA, Berry-Kravis EM, Weese-Mayer DE. PHOX2B mutation-confirmed congenital central hypoventilation syndrome: presentation ... on PubMed Axelrod FB, Chelimsky GG, Weese-Mayer DE. Pediatric autonomic disorders. Pediatrics. 2006 Jul;118(1): ...

Index to limnological data for southcentral Alaska Lakes

USGS Publications Warehouse

Maurer, M.A.; Woods, P.F.

1987-01-01

South-central Alaska lakes are a valuable natural resource and provide a variety of recreational opportunities to the public. Lakeside development has increased significantly in the past 10 years and several south-central Alaskan lakes have documented pollution problems. Cultural eutrophication, the process by which man-induced nutrient loading to a lake results in large increases in biological productivity, can also produce noxious algae blooms, dissolved oxygen depletion at depth, reduced water transparency, and fish kills. The potential for cultural eutrophication of south-central Alaska lakes prompted the U.S. Geological Survey (USGS) Water Resources Division and the Alaska Department of Natural Resources-Division of Geological and Geophysical Surveys (ADGGS) to provide lake researchers, managers, and the public with this index of published historical and current limnological references. The purpose of the index is to provide reference to the data which can be used to identify and monitor cultural eutrophication of south-central Alaska lakes. (Lantz-PTT)

Programmer's Reference Manual for Dynamic Display Software System

DOT National Transportation Integrated Search

1971-01-01

In 1968, the display sysems group of the Systems Laboratory of the NASA/Electronics Research Center undertook a research task in the area of computer controlled flight information systems for aerospace application. The display laboratory of the Trans...

Environmental Response Laboratory Network (ERLN) WebEDR Quick Reference Guide

EPA Pesticide Factsheets

The Web Electronic Data Review is a web-based system that performs automated data processing on laboratory-submitted Electronic Data Deliverables (EDDs). Enables users to perform technical audits on data, and against Measurement Quality Objectives (MQOs).

Antibody Characterization Lab | Office of Cancer Clinical Proteomics Research

Cancer.gov

The Antibody Characterization Lab (ACL), an intramural reference laboratory located at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, thoroughly characterizes monoclonal antibodies or other renewable affinity binding reagents for use in cancer related research.

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

PubMed

Ceriotti, Ferruccio

2017-07-01

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

Uncertainty evaluation in normalization of isotope delta measurement results against international reference materials.

PubMed

Meija, Juris; Chartrand, Michelle M G

2018-01-01

Isotope delta measurements are normalized against international reference standards. Although multi-point normalization is becoming a standard practice, the existing uncertainty evaluation practices are either undocumented or are incomplete. For multi-point normalization, we present errors-in-variables regression models for explicit accounting of the measurement uncertainty of the international standards along with the uncertainty that is attributed to their assigned values. This manuscript presents framework to account for the uncertainty that arises due to a small number of replicate measurements and discusses multi-laboratory data reduction while accounting for inevitable correlations between the laboratories due to the use of identical reference materials for calibration. Both frequentist and Bayesian methods of uncertainty analysis are discussed.

Software Engineering Laboratory (SEL) relationships, models, and management rules

NASA Technical Reports Server (NTRS)

Decker, William; Hendrick, Robert; Valett, Jon D.

1991-01-01

Over 50 individual Software Engineering Laboratory (SEL) research results, extracted from a review of published SEL documentation, that can be applied directly to managing software development projects are captured. Four basic categories of results are defined and discussed - environment profiles, relationships, models, and management rules. In each category, research results are presented as a single page that summarizes the individual result, lists potential uses of the result by managers, and references the original SEL documentation where the result was found. The document serves as a concise reference summary of applicable research for SEL managers.

[Antimicrobial resistance testing in clinical practice].

PubMed

Doi, Yohei

2012-02-01

Previously unrecognized or underrecognized antimicrobial resistant bacteria, including NDM-1-producing Enterobacteriaceae and multidrug-resistant Acinetobacter baumannii, were recently identified in health care facilities in Japan. Vigilance in the clinical microbiology laboratory for these organisms is the key to early recognition of their emergence. Many of these organisms can be confirmed or at least suspected through routine susceptibility testing, which can then be referred to reference laboratories for further phenotypic or genetic testing. Antimicrobial resistance testing plays a crucial role in patient management, infection control and monitoring of local as well as national and international epidemiology.

Assembly of a Robust and Economical MnO[subscript2]-Based Reference Electrode

ERIC Educational Resources Information Center

Masse´, Robert C.; Gerken, James B.

2015-01-01

There is a dearth of base-stable reference electrodes that are suitable for use by students in a teaching laboratory or undergraduate research context. To remedy this, we have developed a technique to produce reference electrodes suitable for alkaline environments. By utilizing components of a commercially available alkaline-type battery, an…

Construction of Ag/AgCl Reference Electrode from Used Felt-Tipped Pen Barrel for Undergraduate Laboratory

ERIC Educational Resources Information Center

Inamdar, Shaukatali N.; Bhat, Mohsin A.; Haram, Santosh K.

2009-01-01

A reference electrode is one of the prerequisites of electrochemical investigations. Many electrodes are commercially available but are expensive and prone to accidental breakage by students. Here we report a simple, easy-to-fabricate, inexpensive, reliable, unbreakable, and reproducible Ag/AgCl reference electrode. The empty barrel of a…

Interlaboratory comparison for the measurement of particle size and zeta potential of silica nanoparticles in an aqueous suspension

NASA Astrophysics Data System (ADS)

Lamberty, Andrée; Franks, Katrin; Braun, Adelina; Kestens, Vikram; Roebben, Gert; Linsinger, Thomas P. J.

2011-12-01

The Institute for Reference Materials and Measurements has organised an interlaboratory comparison (ILC) to allow the participating laboratories to demonstrate their proficiency in particle size and zeta potential measurements on monomodal aqueous suspensions of silica nanoparticles in the 10-100 nm size range. The main goal of this ILC was to identify competent collaborators for the production of certified nanoparticle reference materials. 38 laboratories from four different continents participated in the ILC with different methods for particle sizing and determination of zeta potential. Most of the laboratories submitted particle size results obtained with centrifugal liquid sedimentation (CLS), dynamic light scattering (DLS) or electron microscopy (EM), or zeta potential values obtained via electrophoretic light scattering (ELS). The results of the laboratories were evaluated using method-specific z scores, calculated on the basis of consensus values from the ILC. For CLS (13 results) and EM (13 results), all reported values were within the ±2 | z| interval. For DLS, 25 of the 27 results reported were within the ±2 | z| interval, the two other results were within the ±3 | z| interval. The standard deviations of the corresponding laboratory mean values varied between 3.7 and 6.5%, which demonstrates satisfactory interlaboratory comparability of CLS, DLS and EM particle size values. From the received test reports, a large discrepancy was observed in terms of the laboratory's quality assurance systems, which are equally important for the selection of collaborators in reference material certification projects. Only a minority of the participating laboratories is aware of all the items that are mandatory in test reports compliant to ISO/IEC 17025 (ISO General requirements for the competence of testing and calibration laboratories. International Organisation for Standardization, Geneva, 2005b). The absence of measurement uncertainty values in the reports, for example, hindered the calculation of zeta scores.

Evaluation of the Use of Remote Laboratories for Secondary School Science Education

ERIC Educational Resources Information Center

Lowe, David; Newcombe, Peter; Stumpers, Ben

2013-01-01

Laboratory experimentation is generally considered central to science-based education. Allowing students to "experience" science through various forms of carefully designed practical work, including experimentation, is often claimed to support their learning and motivate their engagement while fulfilling specific curriculum requirements. However,…

Benefits of a comprehensive quality program for cryopreserved PBMC covering 28 clinical trials sites utilizing an integrated, analytical web-based portal

PubMed Central

Ducar, Constance; Smith, Donna; Pinzon, Cris; Stirewalt, Michael; Cooper, Cristine; McElrath, M. Juliana; Hural, John

2014-01-01

The HIV Vaccine Trials Network (HVTN) is a global network of 28 clinical trial sites dedicated to identifying an effective HIV vaccine. Cryopreservation of high-quality peripheral blood mononuclear cells (PBMC) is critical for the assessment of vaccine-induced cellular immune functions. The HVTN PBMC Quality Management Program is designed to ensure viable PBMC are processed, stored and shipped for clinical trial assays from all HVTN clinical trial sites. The program has evolved by developing and incorporating best practices for laboratory and specimen quality and implementing automated, web-based tools. These tools allow the site-affiliated processing laboratories and the central Laboratory Operations Unit to rapidly collect, analyze and report PBMC quality data. The HVTN PBMC Quality Management Program includes five key components: 1) Laboratory Assessment, 2) PBMC Training and Certification, 3) Internal Quality Control, 4) External Quality Control (EQC), and 5) Assay Specimen Quality Control. Fresh PBMC processing data is uploaded from each clinical site processing laboratory to a central HVTN Statistical and Data Management Center database for access and analysis on a web portal. Samples are thawed at a central laboratory for assay or specimen quality control and sample quality data is uploaded directly to the database by the central laboratory. Four year cumulative data covering 23,477 blood draws reveals an average fresh PBMC yield of 1.45×106 ±0.48 cells per milliliter of useable whole blood. 95% of samples were within the acceptable range for fresh cell yield of 0.8–3.2×106 cells/ml of usable blood. Prior to full implementation of the HVTN PBMC Quality Management Program, the 2007 EQC evaluations from 10 international sites showed a mean day 2 thawed viability of 83.1% and recovery of 67.5%. Since then, four year cumulative data covering 3338 specimens used in immunologic assays shows that 99.88% had acceptable viabilities (>66%) for use in cellular assays (mean, 91.46% ±4.5%), and 96.2% had acceptable recoveries (50%–130%) with a mean of recovery of 85.8% ±19.12% of the originally cryopreserved cells. EQC testing revealed that since August 2009, failed recoveries dropped from 4.1% to 1.6% and failed viabilities dropped from 1.0% to 0.3%. The HVTN PBMC quality program provides for laboratory assessment, training and tools for identifying problems, implementing corrective action and monitoring for improvements. These data support the benefits of implementing a comprehensive, web-based PBMC quality program for large clinical trials networks. PMID:24709391

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.

Central African Field Epidemiology and Laboratory Training Program: building and strengthening regional workforce capacity in public health.

PubMed

Andze, Gervais Ondobo; Namsenmo, Abel; Illunga, Benoit Kebella; Kazambu, Ditu; Delissaint, Dieula; Kuaban, Christopher; Mbopi-Kéou, Francois-Xavier; Gabsa, Wilfred; Mulumba, Leopold; Bangamingo, Jean Pierre; Ngulefac, John; Dahlke, Melissa; Mukanga, David; Nsubuga, Peter

2011-01-01

The Central African Field Epidemiology and Laboratory Training Program (CAFELTP) is a 2-year public health leadership capacity building training program. It was established in October 2010 to enhance capacity for applied epidemiology and public health laboratory services in three countries: Cameroon, Central African Republic, and the Democratic Republic of Congo. The aim of the program is to develop a trained public health workforce to assure that acute public health events are detected, investigated, and responded to quickly and effectively. The program consists of 25% didactic and 75% practical training (field based activities). Although the program is still in its infancy, the residents have already responded to six outbreak investigations in the region, evaluated 18 public health surveillance systems and public health programs, and completed 18 management projects. Through these various activities, information is shared to understand similarities and differences in the region leading to new and innovative approaches in public health. The program provides opportunities for regional and international networking in field epidemiology and laboratory activities, and is particularly beneficial for countries that may not have the immediate resources to host an individual country program. Several of the trainees from the first cohort already hold leadership positions within the ministries of health and national laboratories, and will return to their assignments better equipped to face the public health challenges in the region. They bring with them knowledge, practical training, and experiences gained through the program to shape the future of the public health landscape in their countries.

Central African Field Epidemiology and Laboratory Training Program: building and strengthening regional workforce capacity in public health

PubMed Central

Ondobo Andze, Gervais; Namsenmo, Abel; Kebella Illunga, Benoit; Kazambu, Ditu; Delissaint, Dieula; Kuaban, Christopher; Mbopi-Kéou, Francois-Xavier; Gabsa, Wilfred; Mulumba, Leopold; Pierre Bangamingo, Jean; Ngulefac, John; Dahlke, Melissa; Mukanga, David; Nsubuga, Peter

2011-01-01

The Central African Field Epidemiology and Laboratory Training Program (CAFELTP) is a 2-year public health leadership capacity building training program. It was established in October 2010 to enhance capacity for applied epidemiology and public health laboratory services in three countries: Cameroon, Central African Republic, and the Democratic Republic of Congo. The aim of the program is to develop a trained public health workforce to assure that acute public health events are detected, investigated, and responded to quickly and effectively. The program consists of 25% didactic and 75% practical training (field based activities). Although the program is still in its infancy, the residents have already responded to six outbreak investigations in the region, evaluated 18 public health surveillance systems and public health programs, and completed 18 management projects. Through these various activities, information is shared to understand similarities and differences in the region leading to new and innovative approaches in public health. The program provides opportunities for regional and international networking in field epidemiology and laboratory activities, and is particularly beneficial for countries that may not have the immediate resources to host an individual country program. Several of the trainees from the first cohort already hold leadership positions within the ministries of health and national laboratories, and will return to their assignments better equipped to face the public health challenges in the region. They bring with them knowledge, practical training, and experiences gained through the program to shape the future of the public health landscape in their countries. PMID:22359692

Inter-laboratory variation in the chemical analysis of acidic forest soil reference samples from eastern North America

Treesearch

D.S. Ross; S.W. Bailey; R.D. Briggs; J. Curry; I.J. Fernandez; G. Fredriksen; C.L. Goodale; P.W. Hazlett; P.R. Heine; C.E. Johnson; J.T. Larson; G.B. Lawrence; R.K. Kolka; R. Ouimet; D. Pare; D. deB Richter; C.D. Schirmer; R.A. Warby

2015-01-01

Long-term forest soil monitoring and research often requires a comparison of laboratory data generated at different times and in different laboratories. Quantifying the uncertainty associated with these analyses is necessary to assess temporal changes in soil properties. Forest soil chemical properties, and methods to measure these properties, often differ from...

Critical laboratory values in hemostasis: toward consensus.

PubMed

Lippi, Giuseppe; Adcock, Dorothy; Simundic, Ana-Maria; Tripodi, Armando; Favaloro, Emmanuel J

2017-09-01

The term "critical values" can be defined to entail laboratory test results that significantly lie outside the normal (reference) range and necessitate immediate reporting to safeguard patient health, as well as those displaying a highly and clinically significant variation compared to previous data. The identification and effective communication of "highly pathological" values has engaged the minds of many clinicians, health care and laboratory professionals for decades, since these activities are vital to good laboratory practice. This is especially true in hemostasis, where a timely and efficient communication of critical values strongly impacts patient management. Due to the heterogeneity of available data, this paper is hence aimed to analyze the state of the art and provide an expert opinion about the parameters, measurement units and alert limits pertaining to critical values in hemostasis, thus providing a basic document for future consultation that assists laboratory professionals and clinicians alike. KEY MESSAGES Critical values are laboratory test results significantly lying outside the normal (reference) range and necessitating immediate reporting to safeguard patient health. A broad heterogeneity exists about critical values in hemostasis worldwide. We provide here an expert opinion about the parameters, measurement units and alert limits pertaining to critical values in hemostasis.

Analysis of Carbamate Pesticides: Validation of Semi-Volatile Analysis by HPLC-MS/MS by EPA Method MS666

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

Owens, J; Koester, C

The Environmental Protection Agency's (EPA) Region 5 Chicago Regional Laboratory (CRL) developed a method for analysis of aldicarb, bromadiolone, carbofuran, oxamyl, and methomyl in water by high performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS), titled Method EPA MS666. This draft standard operating procedure (SOP) was distributed to multiple EPA laboratories and to Lawrence Livermore National Laboratory, which was tasked to serve as a reference laboratory for EPA's Environmental Reference Laboratory Network (ERLN) and to develop and validate analytical procedures. The primary objective of this study was to validate and verify the analytical procedures described in MS666 for analysis of carbamatemore » pesticides in aqueous samples. The gathered data from this validation study will be used to: (1) demonstrate analytical method performance; (2) generate quality control acceptance criteria; and (3) revise the SOP to provide a validated method that would be available for use during a homeland security event. The data contained in this report will be compiled, by EPA CRL, with data generated by other EPA Regional laboratories so that performance metrics of Method EPA MS666 can be determined.« less

Analysis of Ethanolamines: Validation of Semi-Volatile Analysis by HPLC-MS/MS by EPA Method MS888

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

Owens, J; Vu, A; Koester, C

The Environmental Protection Agency's (EPA) Region 5 Chicago Regional Laboratory (CRL) developed a method titled 'Analysis of Diethanolamine, Triethanolamine, n-Methyldiethanolamine, and n-Ethyldiethanolamine in Water by Single Reaction Monitoring Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS): EPA Method MS888'. This draft standard operating procedure (SOP) was distributed to multiple EPA laboratories and to Lawrence Livermore National Laboratory, which was tasked to serve as a reference laboratory for EPA's Environmental Reference Laboratory Network (ERLN) and to develop and validate analytical procedures. The primary objective of this study was to validate and verify the analytical procedures described in 'EPA Method MS888' for analysis of themore » listed ethanolamines in aqueous samples. The gathered data from this validation study will be used to: (1) demonstrate analytical method performance; (2) generate quality control acceptance criteria; and (3) revise the SOP to provide a validated method that would be available for use during a homeland security event. The data contained in this report will be compiled, by EPA CRL, with data generated by other EPA Regional laboratories so that performance metrics of 'EPA Method MS888' can be determined.« less