Open AccessValidation of a quantitative RNA PCR assay for HIV‐1 in human plasma
Author(s) -
Wathen L. K.,
Crampton D. J.,
Patel R. K.,
Nuorala K. W.,
Poppe S. M.,
Dueweke T. J.,
Re' K. A.,
Krieger K. S.,
Tarpley W. G.
Publication year - 1996
Publication title -
journal of clinical laboratory analysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.536
H-Index - 50
eISSN - 1098-2825
pISSN - 0887-8013
DOI - 10.1002/(sici)1098-2825(1996)10:5<262::aid-jcla6>3.0.co;2-a
Subject(s) - viral load , rna , virology , liter , virus , real time polymerase chain reaction , reverse transcriptase , human immunodeficiency virus (hiv) , microbiology and biotechnology , lentivirus , biology , medicine , viral disease , biochemistry , gene
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 mm 3 , viral RNA levels were quantifiable and ranged from ∼ 3,000–52,200,000 copies per milliliter. Median plasma HIV‐1 RNA values were inversely proportional to CD4 + counts from 0–400 cells per mm 3 . 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. © 1996 Wiley‐Liss, Inc.