Validation of a quantitative RNA PCR assay for HIV-1 in human plasma

✍ Scribed by L. K. Wathen; D. J. Crampton; R. K. Patel; K. W. Nuorala; S. M. Poppe; T. J. Dueweke; K. A. Re'; K. S. Krieger; W. G. Tarpley

• Publisher: John Wiley and Sons
• Year: 1996
• Tongue: English
• Weight: 699 KB
• Volume: 10
• Category: Article
• ISSN: 0887-8013
• DOI: 10.1002/(sici)1098-2825(1996)10:5<262::aid-jcla6>3.0.co;2-a

✦ Synopsis

A quantitative human immunodeficiency virus type 1 (HIV-1) RNA polymerase chain reaction assay has been validated analytically and clinically in > 13,000 samples. The assay is highly reproducible with intra-and inter-assay precision of 16% and 19%, respectively. In 1,542 of 1,548 subjects with CD4' counts of 0-500 cells per mm3, viral RNA levels were quantifiable and ranged from -3,000-52,200,000 copies per milliliter. Median plasma HIV-1 RNA values were inversely propodional to CD4' counts from 0400 cells per mm3. When patients were off antiretroviral therapies for -14 days prior to the initial baseline RNA PCR evaluation, the mean variance between the two baseline values was 23% (0.1 log). Of these patients, 95% had a sufficient plasma viral load to quantitate a 10-fold (1 log) diminution in viral load caused by antiviral therapy. In contrast, only 20% and 45% of these subjects had sufficient p24 and ICD p24 levels to detect a 50% diminution in circulating virus.The high precision and reproducibility of this quantitative RNA PCR assay provide an enhanced means of evaluating therapeutic drug regimens for HIV-1. o 1996Wiley-Liss, Inc.