Laboratory evaluation of the Liat HIV Quant (IQuum) whole-blood and plasma HIV-1 viral load assays for point-of-care testing in South Africa.
Point-of-care (POC) HIV viral load (VL) testing offers the potential to reduce turnaround times for antiretroviral therapy monitoring, offer near-patient acute HIV diagnosis in adults, extend existing centralized VL services, screen women in labor, and prompt pediatrics to early treatment. The Liat HIV Quant plasma and whole-blood assays, prerelease version, were evaluated in South Africa. The precision, accuracy, linearity, and agreement of the Liat HIV Quant whole-blood and plasma assays were compared to those of reference technologies (Roche CAP CTMv2.0 and Abbott RealTime HIV-1) on an HIV verification plasma panel (n = 42) and HIV clinical specimens (n = 163). HIV Quant plasma assay showed good performance, with a 2.7% similarity coefficient of variation (CV) compared to the Abbott assay and a 1.8% similarity CV compared to the Roche test on the verification panel, and 100% specificity. HIV Quant plasma had substantial agreement (pc [concordance correlation] = 0.96) with Roche on clinical specimens and increased variability (pc = 0.73) in the range of <3.0 log copies/ml range with the HIV Quant whole-blood assay. HIV Quant plasma assay had good linearity (2.0 to 5.0 log copies/ml; R(2) = 0.99). Clinical sensitivity at a viral load of 1,000 copies/ml of the HIV Quant plasma and whole-blood assays compared to that of the Roche assay (n = 94) was 100% (confidence interval [CI], 95.3% to 100%). The specificity of HIV Quant plasma was 88.2% (CI, 63.6% to 98.5%), and that for whole blood was 41.2% (CI, 18.4% to 67.1%). No virological failure (downward misclassification) was missed. Liat HIV Quant plasma assay can be interchanged with existing VL technology in South Africa. Liat HIV Quant whole-blood assay would be advantageous for POC early infant diagnosis at birth and adult adherence monitoring and needs to be evaluated further in this clinical context. LIAT cartridges currently require cold storage, but the technology is user-friendly and robust. Clinical cost and implementation modeling is required.
Department of Haematology and Molecular Medicine, School of Pathology, Faculty of Health Science, University of Witwatersrand, Johannesburg, South Africa Lesley.Scott@nhls.ac.za.
Lesley
L
Scott
Department of Haematology and Molecular Medicine, School of Pathology, Faculty of Health Science, University of Witwatersrand, Johannesburg, South Africa.
Natasha
N
Gous
Department of Haematology and Molecular Medicine, School of Pathology, Faculty of Health Science, University of Witwatersrand, Johannesburg, South Africa National Health Laboratory Services, National Priority Program, Johannesburg, South Africa.
Sergio
S
Carmona
Department of Haematology and Molecular Medicine, School of Pathology, Faculty of Health Science, University of Witwatersrand, Johannesburg, South Africa National Health Laboratory Services, National Priority Program, Johannesburg, South Africa.
Wendy
W
Stevens
D000328:Adult; D001769:Blood / Q000821:virology*; D015658:HIV Infections / Q000821:virology*; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D000067716:Point-of-Care Testing; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013019:South Africa; D019562:Viral Load / Q000379:methods*