Comparative evaluation of the QUANTIPLEX HIV-1 RNA 2.0 and 3.0 (bDNA) assays and the AMPLICOR HIV-1 MONITOR v1.5 test for the quantitation of human immunodeficiency virus type 1 RNA in plasma

HIV-1 RNA measurements from 84 plasma specimens obtained with the QUANTIPLE X HIV-1 RNA 2.0 and 3.0 (bDNA) assays (Chiron Diagnostics, Emeryville, CA) and with the AMPLICOR HIV-1 MONITOR (TM) Test, version 1.5 with ultra-sensi tive specimen preparation (Roche Diagnostic Systems, Inc., Branchburg, NJ) were compared. The absolute RNA values of tested specimens differed signifi cantly between bDNA 2.0 and bDNA 3.0 or Monitor v1.5 measurements (Wilcoxon signed-rank test P < 0.001). Results generated with bDNA 3.0 or with Monit or v1.5 were approximately twofold greater than those generated with bDNA 2 .0, with smaller differences at higher HIV-1 RNA levels and greater differe nces at RNA levels below 1000 copies per mi. Although highly correlated (r = 0.92 and 0.86, respectively), viral load data generated with bDNA 2.0 and either bDNA 3.0 or Monitor v1.5 were in poor agreement. Concordant results (difference in log(10) copies per ml < 0.5) were found at frequencies of 8 0% for bDNA 2.0 and bDNA 3.0 and only at 58.5% for bDNA 2.0 and Monitor v1. 5. In contrast, bDNA 3.0 and Monitor v1.5 measurements were highly correlat ed (r = 0.96) and in good agreement (92.7%). (C) 2001 Elsevier Science B.V. All rights reserved.