Evaluation of the Abbott m2000rt RealTime™ HIV-1 assay with manual sample preparation compared with the ROCHE COBAS® AmpliPrep™/AMPLICOR™ HIV-1 MONITOR® v1.5 using specimens from East Africa

Abstract: The performance of the Abbott m2000rt RealTime™ HIV-1 assay (RealTime HIV-1) with manual sample preparation was compared against the ROCHE COBAS® AmpliPrep™/AMPLICOR™ HIV-1 MONITOR® Test v1.5 (CAP/CA HIV-1) using samples collected from 100 donors infected with HIV and 20 donors not infected with HIV in northern Tanzania where HIV-1 subtypes A, C, D, and their recombinant forms predominate. The RealTime HIV-1 appeared to have more within-run variability at high HIV-1 RNA concentrations, but total assay variability over the dynamic range tested was within the manufacturer''s claim of <0.3SDcopies/mL. Accuracy studies showed 100% concordance for positive and negative values. When continuous values were examined, CAP/CA HIV-1 yielded higher values than the RealTime HIV-1 at higher nominal HIV-1 RNA concentrations. The RealTime HIV-1 assay showed excellent linearity between 2.5 and 7.0logcopies/mL. Of negative samples, 100% showed negative results, and >95% of samples with nominal concentrations of 40copies/mL were detected at ≥40copies/mL by RealTime HIV-1. Manual sample preparation may contribute to higher total assay variability. This study suggests that the Abbott m2000rt RealTime HIV-1 assay with manual sample preparation is an acceptable and feasible alternative to the conventional ROCHE COBAS AmpliPrep/AMLICOR HIV-1 Monitor v1.5 assay and that the RealTime HIV-1 assay performs well on samples from East Africa. [Copyright &y& Elsevier]