Papers Published

1. JA Crump, LE Scott, E Msuya, AB Morrissey, EE Kimaro, JF Shao, WS Stevens, Evaluation of the Abbott m2000rt RealTime HIV-1 assay with manual sample preparation compared with the ROCHE COBAS((R)) AmpliPrep/AMPLICOR HIV-1 MONITOR((R)) v1.5 using specimens from East Africa., Journal of virological methods, Netherlands, vol. 162 no. 1-2 (December, 2009), pp. 218-22, ISSN 1879-0984
   (last updated on 2009/10/13)

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