Clinical Evaluation of Branched DNA Signal Amplification for Quantifying HIV Type 1 in Human Plasma

Yunzhen Cao, David D. ho, John Todd, Robert Kokka, Mickey Urdea, Jeffrey D. Lifson, Michael Piatak, Shande Chen, Beatrice H. Hahn, Michael S. Saag, George M. Shaw

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108 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)353-361
Number of pages9
JournalAIDS Research and Human Retroviruses
Volume11
Issue number3
DOIs
StatePublished - Mar 1995

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    Cao, Y., ho, D. D., Todd, J., Kokka, R., Urdea, M., Lifson, J. D., Piatak, M., Chen, S., Hahn, B. H., Saag, M. S., & Shaw, G. M. (1995). Clinical Evaluation of Branched DNA Signal Amplification for Quantifying HIV Type 1 in Human Plasma. AIDS Research and Human Retroviruses, 11(3), 353-361. https://doi.org/10.1089/aid.1995.11.353