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Journal of Clinical Microbiology, July 2009, p. 2209-2217, Vol. 47, No. 7
0095-1137/09/$08.00+0     doi:10.1128/JCM.01761-08
Copyright © 2009, American Society for Microbiology. All Rights Reserved.

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 EasyQ HIV-1 Assays{triangledown}

Lesley E. Scott,1* Lara D. Noble,1 Jackie Moloi,1 Linda Erasmus,1 Willem D. F. Venter,2 and Wendy Stevens1

Department of Molecular Medicine and Haematology, University of Witwatersrand, Faculty of Health Sciences, School of Pathology, 7 York Road Parktown, Room 3B20, Johannesburg 2000, South Africa,1 Reproductive Health and HIV Research Unit, University of Witwatersrand, Johannesburg, South Africa2

Received 12 September 2008/ Returned for modification 4 November 2008/ Accepted 12 April 2009

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.

* Corresponding author. Mailing address: Department of Molecular Medicine and Haematology, University of Witwatersrand, Faculty of Health Sciences, School of Pathology, 7 York Road Parktown, Room 3B20, Johannesburg 2000, South Africa. Phone: 27 11 489 8567. Fax: 27 484 5812. E-mail: lesley.scott{at}nhls.ac.za

{triangledown} Published ahead of print on 6 May 2009.

Journal of Clinical Microbiology, July 2009, p. 2209-2217, Vol. 47, No. 7
0095-1137/09/$08.00+0     doi:10.1128/JCM.01761-08
Copyright © 2009, American Society for Microbiology. All Rights Reserved.





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