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

The performance of the Abbott m2000rt RealTime(TM) HIV-1 assay (RealTime HIV-1) with manual sample preparation was compared against the ROCHE COBAS super(()R) AmpliPrep(TM)/AMPLICOR(TM) HIV-1 MONITOR super(()R) 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 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.