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

Hsiang Ju Lin, Lawrence E. Myers, Belinda Yen-Lieberman, F. Blaine Hollinger, Denis Henrard, Carol J. Hooper, Robert Kokka, Shirley Kwok, Suraiya Rasheed, Maryanne Vahey, Mark A. Winters, Lisa J. Mc Quay, Peter L. Nara, Patricia Reichelderfer, Robert W. Coombs, J. Brooks Jackson

Research output: Contribution to journalArticlepeer-review

132 Scopus citations


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 IO-folddilution series of HIV-L-spiked plasma were correctly ranked by all six procedures. Subsequently, coded duplicate plasma samples from 16 HIV-I-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-I RNA levels in the patients (up to 370, 000 RNA copiesjmL) correlated with proviral HIV-I 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.

Original languageEnglish (US)
Pages (from-to)553-562
Number of pages10
JournalJournal of Infectious Diseases
Issue number3
StatePublished - Sep 1994
Externally publishedYes


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