Multicenter evaluation of quantification methods for plasma human immunodeficiency virus type 1 RNA.
Six procedures for quantifying plasma human immunodeficiency virus type 1 (HIV-1) RNA were evaluated by nine laboratories. The procedures differed in their sample volume and preparation of samples and methods of amplification and detection. Coded samples in a 10-fold dilution series of HIV-1-spiked plasma were correctly ranked by all six procedures. Subsequently, coded duplicate plasma samples from 16 HIV-1-infected patients were tested using a common set of standards. Several HIV-1 RNA procedures were sufficiently reproducible so that an empiric 4-fold change could be viewed as significant. HIV-1 RNA levels in the patients (up to 370,000 RNA copies/mL) correlated with proviral HIV-1 DNA and were inversely correlated with CD4 cell counts; HIV-1 RNA assays were more sensitive than plasma viremia, standard p24 antigen, or immune complex-dissociated p24 antigen assays. This study demonstrated that several HIV-1 RNA quantitative assays are ready for use in clinical trials.
Lin
H J
HJ
Division of Molecular Virology, Baylor College of Medicine, Houston, Texas.
Myers
L E
LE
Yen-Lieberman
B
B
Hollinger
F B
FB
Henrard
D
D
Hooper
C J
CJ
Kokka
R
R
Kwok
S
S
Rasheed
S
S
Vahey
M
M
D000163:Acquired Immunodeficiency Syndrome / Q000097:blood / Q000175:diagnosis*; D001800:Blood Specimen Collection; D015496:CD4-Positive T-Lymphocytes; D016655:HIV Core Protein p24 / Q000097:blood; D018023:HIV Seronegativity; D006679:HIV Seropositivity / Q000097:blood / Q000175:diagnosis*; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D007753:Laboratories / Q000592:standards; D007958:Leukocyte Count; D011237:Predictive Value of Tests; D012367:RNA, Viral / Q000097:blood*; D012680:Sensitivity and Specificity; D014766:Viremia / Q000097:blood
D016655:HIV Core Protein p24; D012367:RNA, Viral