Multicenter evaluation of quantification methods for plasma human immunodeficiency virus type 1 RNA

J Infect Dis. 1994 Sep;170(3):553-62. doi: 10.1093/infdis/170.3.553.

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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Acquired Immunodeficiency Syndrome / blood
  • Acquired Immunodeficiency Syndrome / diagnosis*
  • Blood Specimen Collection
  • CD4-Positive T-Lymphocytes
  • HIV Core Protein p24 / blood
  • HIV Seronegativity*
  • HIV Seropositivity / blood
  • HIV Seropositivity / diagnosis*
  • HIV-1 / isolation & purification*
  • Humans
  • Laboratories / standards
  • Leukocyte Count
  • Predictive Value of Tests
  • RNA, Viral / blood*
  • Sensitivity and Specificity
  • Viremia / blood

Substances

  • HIV Core Protein p24
  • RNA, Viral