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.
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.
Yen-Lieberman
B
B
Cleveland Clinic Foundation, University Hospitals of Cleveland, Ohio, USA.
Brambilla
D
D
Jackson
B
B
Bremer
J
J
Coombs
R
R
Cronin
M
M
Herman
S
S
Katzenstein
D
D
Leung
S
S
Lin
H J
HJ
Palumbo
P
P
Rasheed
S
S
Todd
J
J
Vahey
M
M
Reichelderfer
P
P
D002985:Clinical Protocols / Q000592:standards; D002986:Clinical Trials as Topic / Q000592:standards; D005069:Evaluation Studies as Topic; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D007753:Laboratories; D015337:Multicenter Studies as Topic / Q000592:standards; D009316:National Institutes of Health (U.S.); D011786:Quality Control; D012367:RNA, Viral / Q000097:blood* / Q000235:genetics / Q000592:standards*; D012015:Reference Standards; D014481:United States; D014773:Virology / Q000379:methods* / Q000592:standards*
D012367:RNA, Viral