TY - JOUR
T1 - Clinical Evaluation of Branched DNA Signal Amplification for Quantifying HIV Type 1 in Human Plasma
AU - Cao, Yunzhen
AU - ho, David D.
AU - Todd, John
AU - Kokka, Robert
AU - Urdea, Mickey
AU - Lifson, Jeffrey D.
AU - Piatak, Michael
AU - Chen, Shande
AU - Hahn, Beatrice H.
AU - Saag, Michael S.
AU - Shaw, George M.
PY - 1995/3
Y1 - 1995/3
N2 - Quantification of HIV-1 RNA in human plasma has provided unique insight into AIDS pathogenesis and promises to hasten progress in antiretroviral therapy and vaccine research. However, no generally available HIV-1 RNA assay has yet been subjected to rigorous clinical testing or to comparative evaluation with research-based RNA assays using large numbers of well-characterized clinical specimens. In this study, the Chiron Quantiplex branched DNA (bDNA) signal amplification assay was used to measure viral RNA in the plasma of 152 HIV-1-positive individuals at all stages of infection and in 12 patients before and after initiating zidovudine therapy. Eighty-six percent of patients had bDNA assay results above the 10,000-RNA Eq/ml sensitivity cutoff. Branched DNA values were significantly correlated with plasma viral RNA levels determined by quantitative competitive polymerase chain reaction (QC-PCR) assay (Spearman rank correlation, r = 0.89), infectious plasma virus titers (r = 0.72), p24 antigen levels (r = 0.51), immune complex dissociated p24 antigen levels (r = 0.56), and CD4+ lymphocyte counts (r = -0.72; p < 0.0001 for all comparisons). Plasma viral RNA determinations by bDNA and QC-PCR assays were quantitatively similar in the range of 104 to 107 RNA molecules/ml [log bDNA = 0.93 + 0.80 (log QC-PCR); R = 0.81,p < 0.0001] and declined identically following the institution of zidovudine therapy (68-73% decrease from baseline). The close quantitative correlation between bDNA and QC-PCR results, and their significant association with other viral markers and CD4+ counts, support the use of plasma viral RNA measurement in HIV-1 clinical trials.
AB - Quantification of HIV-1 RNA in human plasma has provided unique insight into AIDS pathogenesis and promises to hasten progress in antiretroviral therapy and vaccine research. However, no generally available HIV-1 RNA assay has yet been subjected to rigorous clinical testing or to comparative evaluation with research-based RNA assays using large numbers of well-characterized clinical specimens. In this study, the Chiron Quantiplex branched DNA (bDNA) signal amplification assay was used to measure viral RNA in the plasma of 152 HIV-1-positive individuals at all stages of infection and in 12 patients before and after initiating zidovudine therapy. Eighty-six percent of patients had bDNA assay results above the 10,000-RNA Eq/ml sensitivity cutoff. Branched DNA values were significantly correlated with plasma viral RNA levels determined by quantitative competitive polymerase chain reaction (QC-PCR) assay (Spearman rank correlation, r = 0.89), infectious plasma virus titers (r = 0.72), p24 antigen levels (r = 0.51), immune complex dissociated p24 antigen levels (r = 0.56), and CD4+ lymphocyte counts (r = -0.72; p < 0.0001 for all comparisons). Plasma viral RNA determinations by bDNA and QC-PCR assays were quantitatively similar in the range of 104 to 107 RNA molecules/ml [log bDNA = 0.93 + 0.80 (log QC-PCR); R = 0.81,p < 0.0001] and declined identically following the institution of zidovudine therapy (68-73% decrease from baseline). The close quantitative correlation between bDNA and QC-PCR results, and their significant association with other viral markers and CD4+ counts, support the use of plasma viral RNA measurement in HIV-1 clinical trials.
UR - http://www.scopus.com/inward/record.url?scp=0028986503&partnerID=8YFLogxK
U2 - 10.1089/aid.1995.11.353
DO - 10.1089/aid.1995.11.353
M3 - Article
C2 - 7786581
AN - SCOPUS:0028986503
SN - 0889-2229
VL - 11
SP - 353
EP - 361
JO - AIDS Research and Human Retroviruses
JF - AIDS Research and Human Retroviruses
IS - 3
ER -