Comparison of two amplification technologies for detection and quantitation of human immunodeficiency virus type 1 RNA in the female genital tract

Human immunodeficiency virus type 1 (HIV-1) RNA levels in female genital tr act and peripheral blood samples were compared using two commercial amplifi cation technologies: the Roche AMPLICOR HIV-1 MONITOR test and either the O rganon Teknika nucleic acid sequence-based amplification (NASBA-QT) assay o r the NucliSens assay. Estimates of HIV-1 RNA copy number were derived from internal kit standards and analyzed unadjusted and adjusted to a common se t of external standards. We found a discordance rate of approximately 18% b etween the two technologies for the detection of HIV-1 in either the genita l tract or peripheral blood samples. Detection discordance was not consiste nt among specimens or among women. There were no significant differences In adjusted or unadjusted estimates of HIV-1 RNA copy number in the genital t ract samples using the AMPLICOR HIV-1 MONITOR test and either the NASBA-QT assay or the NucliSens assay, In addition, the estimated HIV-1 RNA copy num ber in peripheral blood samples did not differ when tested with the NucliSe ns assay and the AMPLICOR HIV-1 MONITOR test using kit standards. However, there was a significant difference In estimated RNA copy number between the NASBA-QT assay and the AMPLICOR HIV-1 MONITOR test for internal kit standa rds, which, as we have previously shown, was eliminated after adjustment wi th the external standards. Our results suggest that the Roche and Organon T eknika assays are equivalent for quantifying HIV-1 RNA in female genital tr act specimens, although variation in detection does exist.