title: Multicenter evaluation of quantification methods for plasma human immunodeficiency virus type 1 RNA.
abstract: 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.
authors.affiliation: Division of Molecular Virology, Baylor College of Medicine, Houston, Texas.
authors.forename: H J
authors.initials: HJ
authors.lastname: Lin
authors.forename: L E
authors.initials: LE
authors.lastname: Myers
authors.forename: B
authors.initials: B
authors.lastname: Yen-Lieberman
authors.forename: F B
authors.initials: FB
authors.lastname: Hollinger
authors.forename: D
authors.initials: D
authors.lastname: Henrard
authors.forename: C J
authors.initials: CJ
authors.lastname: Hooper
authors.forename: R
authors.initials: R
authors.lastname: Kokka
authors.forename: S
authors.initials: S
authors.lastname: Kwok
authors.forename: S
authors.initials: S
authors.lastname: Rasheed
authors.forename: M
authors.initials: M
authors.lastname: Vahey
mesh_terms: 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
chemical_list: D016655:HIV Core Protein p24; D012367:RNA, Viral