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

Belinda Yen-Lieberman, Donald Brambilla, Brooks Jackson, James Bremer, Robert Coombs, Mike Cronin, Steven Herman, David Katzenstein, Shiela Leung, Hsiang Ju Lin, Paul Palumbo, Suraiya Rasheed, John Todd, Maryanne Vahey, Patricia Reichelderfer

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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.

Original languageEnglish (US)
Pages (from-to)2695-2701
Number of pages7
JournalJournal of Clinical Microbiology
Volume34
Issue number11
Publication statusPublished - Nov 1996

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ASJC Scopus subject areas

  • Microbiology (medical)
  • Microbiology

Cite this

Yen-Lieberman, B., Brambilla, D., Jackson, B., Bremer, J., Coombs, R., Cronin, M., ... Reichelderfer, P. (1996). 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, 34(11), 2695-2701.