VALIDATION OF A QUANTITATIVE RNA PCR ASSAY FOR HIV-1 IN HUMAN PLASMA

A quantitative human immunodeficiency virus type 1 (HIV-1) RNA polymer ase chain reaction assay has been validated analytically and clinicall y in > 13,000 samples. The assay is highly reproducible with intra- an d inter-assay precision of 16% and 19%, respectively. In 1,542 of 1,54 8 subjects with CD4(+) counts of 0-500 cells per mm(3), viral RNA leve ls were quantifiable and ranged from similar to 3,000-52,200,000 copie s per milliliter. Median plasma HIV-1 RNA values were inversely propor tional to CD4(+) counts from 0-400 cells per mm(3). When patients were off antiretroviral therapies for similar to 14 days prior to the init ial baseline RNA PCR evaluation, the mean variance between the two bas eline values was 23% (0.1 log). Of these patients, 95% had a sufficien t plasma viral load to quantitate a 10-fold (1 log) diminulion in vira l load caused by antiviral therapy. In contrast, only 20% and 45% of t hese subjects had sufficient p24 and ICD p24 levels to detect a 50% di minution in circulating virus. The high precision and reproducibility of this quantitative RNA PCR assay provide an enhanced means of evalua ting therapeutic drug regimens far HIV-1. (C) 1996 Wiley-Liss, Inc.