Journal article
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
Journal of clinical microbiology, Vol.34(11), pp.2695-2701
11/1996
DOI: 10.1128/JCM.34.11.2695-2701.1996
PMCID: PMC229388
PMID: 8897167
Abstract
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.
Details
- Title: Subtitle
- 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
- Creators
- Belinda Yen-Lieberman - Cleveland Clinic Foundation, University Hospitals of Cleveland, Ohio, USADonald Brambilla - Cleveland Clinic Foundation, University Hospitals of Cleveland, Ohio, USABrooks Jackson - Cleveland Clinic Foundation, University Hospitals of Cleveland, Ohio, USAJames Bremer - Cleveland Clinic Foundation, University Hospitals of Cleveland, Ohio, USARobert Coombs - Cleveland Clinic Foundation, University Hospitals of Cleveland, Ohio, USAMike Cronin - Cleveland Clinic Foundation, University Hospitals of Cleveland, Ohio, USASteven Herman - Cleveland Clinic Foundation, University Hospitals of Cleveland, Ohio, USADavid Katzenstein - Cleveland Clinic Foundation, University Hospitals of Cleveland, Ohio, USASheila Leung - Cleveland Clinic Foundation, University Hospitals of Cleveland, Ohio, USAHSIANG JU LIN - Cleveland Clinic Foundation, University Hospitals of Cleveland, Ohio, USAPaul Palumbo - Cleveland Clinic Foundation, University Hospitals of Cleveland, Ohio, USASuraiya Rasheed - Cleveland Clinic Foundation, University Hospitals of Cleveland, Ohio, USAJohn Todd - Cleveland Clinic Foundation, University Hospitals of Cleveland, Ohio, USAMaryanne Vahey - Cleveland Clinic Foundation, University Hospitals of Cleveland, Ohio, USAPatricia Reichelderfer - Cleveland Clinic Foundation, University Hospitals of Cleveland, Ohio, USA
- Resource Type
- Journal article
- Publication Details
- Journal of clinical microbiology, Vol.34(11), pp.2695-2701
- DOI
- 10.1128/JCM.34.11.2695-2701.1996
- PMID
- 8897167
- PMCID
- PMC229388
- ISSN
- 0095-1137
- eISSN
- 1098-660X
- Language
- English
- Date published
- 11/1996
- Academic Unit
- Pathology; VPMA - Administration
- Record Identifier
- 9984047699402771
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