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.

Published

Journal Article

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 <0.3 SD copies/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 7.0 log copies/mL. Of negative samples, 100% showed negative results, and >95% of samples with nominal concentrations of 40 copies/mL were detected at > or = 40 copies/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.

Full Text

Duke Authors

Cited Authors

  • Crump, JA; Scott, LE; Msuya, E; Morrissey, AB; Kimaro, EE; Shao, JF; Stevens, WS

Published Date

  • December 2009

Published In

Volume / Issue

  • 162 / 1-2

Start / End Page

  • 218 - 222

PubMed ID

  • 19729037

Pubmed Central ID

  • 19729037

Electronic International Standard Serial Number (EISSN)

  • 1879-0984

Digital Object Identifier (DOI)

  • 10.1016/j.jviromet.2009.08.013

Language

  • eng

Conference Location

  • Netherlands