rdf:type |
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lifeskim:mentions |
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pubmed:issue |
11
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pubmed:dateCreated |
1997-3-10
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pubmed:abstractText |
A number of quantitative assays have been developed by using amplification techniques to measure human immunodeficiency virus type 1 RNA in the plasma of infected individuals. The Virology Committee of the AIDS Clinical Trials Group in the Division of AIDS, National Institute of Allergy and Infectious Diseases, has established a quality assurance program (QAP) for quantitative assays of HIV-1 RNA levels in plasma. The primary objective of the QAP was to ascertain that a laboratory could maintain the precision required to have a 90% power to detect a fivefold difference in RNA copy number between two samples in the same batch. To achieve this goal, the QAP required an intra-assay standard deviation of no greater than 0.15 log10 RNA copies per ml. Panels for proficiency testing consisted of coded replicate samples and a common set of standards. To date, 41 laboratories have participated in the program and have used both commercial and in-house assays. We demonstrated that 65% of the laboratories were capable of attaining the necessary level of intra-assay precision. The fitted regressions indicated that the differences among laboratories that used the same kit were generally greater than the differences among population-average regressions for the kits themselves. The use of an external QAP and a common set of standards reduced differences both among laboratories that used the same kit and among laboratories that used different kits. Thus, use of a common set of standards across clinical trial protocols would allow for cross-protocol comparisons.
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pubmed:grant |
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pubmed:commentsCorrections |
http://linkedlifedata.com/resource/pubmed/commentcorrection/8897167-1371054,
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pubmed:language |
eng
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pubmed:journal |
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pubmed:citationSubset |
IM
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pubmed:chemical |
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pubmed:status |
MEDLINE
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pubmed:month |
Nov
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pubmed:issn |
0095-1137
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pubmed:author |
pubmed-author:BrambillaDD,
pubmed-author:BremerJJ,
pubmed-author:CoombsRR,
pubmed-author:CroninMM,
pubmed-author:HermanSS,
pubmed-author:JacksonBB,
pubmed-author:KatzensteinDD,
pubmed-author:LeungSS,
pubmed-author:LiuH SHS,
pubmed-author:PalumboPP,
pubmed-author:RasheedSS,
pubmed-author:ReichelderferPP,
pubmed-author:ToddJJ,
pubmed-author:VaheyMM,
pubmed-author:Yen-LiebermanBB
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pubmed:issnType |
Print
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pubmed:volume |
34
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
2695-701
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pubmed:dateRevised |
2009-11-18
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pubmed:meshHeading |
pubmed-meshheading:8897167-Clinical Protocols,
pubmed-meshheading:8897167-Clinical Trials as Topic,
pubmed-meshheading:8897167-Evaluation Studies as Topic,
pubmed-meshheading:8897167-HIV-1,
pubmed-meshheading:8897167-Humans,
pubmed-meshheading:8897167-Laboratories,
pubmed-meshheading:8897167-Multicenter Studies as Topic,
pubmed-meshheading:8897167-National Institutes of Health (U.S.),
pubmed-meshheading:8897167-Quality Control,
pubmed-meshheading:8897167-RNA, Viral,
pubmed-meshheading:8897167-Reference Standards,
pubmed-meshheading:8897167-United States,
pubmed-meshheading:8897167-Virology
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pubmed:year |
1996
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pubmed:articleTitle |
Evaluation of a quality assurance program for quantitation of human immunodeficiency virus type 1 RNA in plasma by the AIDS Clinical Trials Group virology laboratories.
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pubmed:affiliation |
Cleveland Clinic Foundation, University Hospitals of Cleveland, Ohio, USA.
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pubmed:publicationType |
Journal Article,
Research Support, U.S. Gov't, P.H.S.
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