Division of Infectious Diseases and International Health, Department of Medicine, Duke University Medical Center, Box 102359, Durham, NC 27710, United States; Duke Global Health Institute, Duke University, Box 90519, Durham, NC 27710, United States; Kilimanjaro Christian Medical Centre, PO Box 3010, Moshi, Tanzania; Kilimanjaro Christian Medical College, Tumaini University, PO Box 2240, Moshi, Tanzania; Department of Molecular Medicine and Haematology, School of Pathology, Faculty of Health Sciences, Private Bag 3, Parktown, Wits 2050, South Africa; National Health Laboratory Service, 1 Modderfontein Road, Sandringham, South Africa
Crump, J.A., Division of Infectious Diseases and International Health, Department of Medicine, Duke University Medical Center, Box 102359, Durham, NC 27710, United States, Duke Global Health Institute, Duke University, Box 90519, Durham, NC 27710, United States, Kilimanjaro Christian Medical Centre, PO Box 3010, Moshi, Tanzania, Kilimanjaro Christian Medical College, Tumaini University, PO Box 2240, Moshi, Tanzania; Scott, L.E., Department of Molecular Medicine and Haematology, School of Pathology, Faculty of Health Sciences, Private Bag 3, Parktown, Wits 2050, South Africa; Msuya, E., Kilimanjaro Christian Medical Centre, PO Box 3010, Moshi, Tanzania; Morrissey, A.B., Division of Infectious Diseases and International Health, Department of Medicine, Duke University Medical Center, Box 102359, Durham, NC 27710, United States; Kimaro, E.E., Kilimanjaro Christian Medical Centre, PO Box 3010, Moshi, Tanzania; Shao, J.F., Kilimanjaro Christian Medical Centre, PO Box 3010, Moshi, Tanzania, Kilimanjaro Christian Medical College, Tumaini University, PO Box 2240, Moshi, Tanzania; Stevens, W.S., Department of Molecular Medicine and Haematology, School of Pathology, Faculty of Health Sciences, Private Bag 3, Parktown, Wits 2050, South Africa, National Health Laboratory Service, 1 Modderfontein Road, Sandringham, South Africa
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 ≥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. © 2009 Elsevier B.V. All rights reserved.