Scott L.E., Noble L.D., Moloi J., Erasmus L., Venter W.D.F., Stevens W.
Evaluation of the Abbott m2000 RealTime human immunodeficiency virus type 1 (HIV-1) assay for HIV load monitoring in South Africa compared to the Roche Cobas AmpliPrep-Cobas Amplicor, Roche Cobas AmpliPrep-Cobas TaqMan HIV-1, and BioMerieux NucliSENS Easy
Department of Molecular Medicine and Haematology, University of Witwatersrand, School of Pathology, 7 York Road Parktown, Johannesburg 2000, South Africa; Reproductive Health and HIV Research Unit, University of Witwatersrand, Johannesburg, South Africa
Scott, L.E., Department of Molecular Medicine and Haematology, University of Witwatersrand, School of Pathology, 7 York Road Parktown, Johannesburg 2000, South Africa; Noble, L.D., Department of Molecular Medicine and Haematology, University of Witwatersrand, School of Pathology, 7 York Road Parktown, Johannesburg 2000, South Africa; Moloi, J., Department of Molecular Medicine and Haematology, University of Witwatersrand, School of Pathology, 7 York Road Parktown, Johannesburg 2000, South Africa; Erasmus, L., Department of Molecular Medicine and Haematology, University of Witwatersrand, School of Pathology, 7 York Road Parktown, Johannesburg 2000, South Africa; Venter, W.D.F., Reproductive Health and HIV Research Unit, University of Witwatersrand, Johannesburg, South Africa; Stevens, W., Department of Molecular Medicine and Haematology, University of Witwatersrand, School of Pathology, 7 York Road Parktown, Johannesburg 2000, South Africa
The implementation of antiretroviral therapy demands the need for increased access to viral load (VL) monitoring. Newer real-time VL testing technologies are faster and have larger dynamic ranges and fully automated extraction to benefit higher throughputs in resource-poor environments. The Abbott RealTime human immunodeficiency virus type 1 (HIV-1) assay was evaluated as a new option for testing for HIV-1 subtype C in South Africa, and its performance was compared to the performance of existing assays (the Cobas AmpliPrep-Cobas TaqMan HIV-1, version 1, assay; the AmpliPrep-Cobas Monitor standard HIV-1 assay; and the NucliSENS EasyQ-EasyMag HIV-1 assay) in a high-throughput laboratory. The total precision of the RealTime HIV-1 assay was acceptable over all viral load ranges. This assay compared most favorably with the Cobas AmpliPrep-Cobas TaqMan HIV-1 assay (R2 = 0.904), with a low standard deviation of difference being detected (0.323 copies/ml). The bias against comparator assays ranged from -0.001 copies/ml to -0.228 copies/ml. Variability in the reporting of VLs for a 20-member subtype panel compared to the variability of other assays was noted with subtypes G and CRF02-AG. The RealTime HIV-1 assay can test 93 samples per day with minimal manual preparation, less staff, and the minimization of contamination through automation. This assay is suitable for HIV-1 subtype C VL quantification in South Africa. Copyright © 2009, American Society for Microbiology. All Rights Reserved.
accuracy; article; controlled study; gene amplification; human; Human immunodeficiency virus 1; intermethod comparison; laboratory automation; major clinical study; nonhuman; priority journal; real time polymerase chain reaction; South Africa; virus load; virus typing; HIV Infections; HIV-1; Humans; Molecular Diagnostic Techniques; Reagent Kits, Diagnostic; South Africa; Viral Load; Human immunodeficiency virus 1