Clinical Evaluation of an Affordable Qualitative Viral Failure Assay for HIV Using Dried Blood Spots in Uganda

PloS One
Sheila N BalindaART–A consortium

Abstract

WHO recommends regular viral load (VL) monitoring of patients on antiretroviral therapy (ART) for timely detection of virological failure, prevention of acquired HIV drug resistance (HIVDR) and avoiding unnecessary switching to second-line ART. However, the cost and complexity of routine VL testing remains prohibitive in most resource limited settings (RLS). We evaluated a simple, low-cost, qualitative viral-failure assay (VFA) on dried blood spots (DBS) in three clinical settings in Uganda. We conducted a cross-sectional diagnostic accuracy study in three HIV/AIDS treatment centres at the Joint Clinical Research Centre in Uganda. The VFA employs semi-quantitative detection of HIV-1 RNA amplified from the LTR gene. We used paired dry blood spot (DBS) and plasma with the COBASAmpliPrep/COBASTaqMan, Roche version 2 (VLref) as the reference assay. We used the VFA at two thresholds of viral load, (>5,000 or >1,000 copies/ml). 496 paired VFA and VLref results were available for comparative analysis. Overall, VFA demonstrated 78.4% sensitivity, (95% CI: 69.7%-87.1%), 93% specificity (95% CI: 89.7%-96.4%), 89.3% accuracy (95% CI: 85%-92%) and an agreement kappa = 0.72 as compared to the VLref. The predictive values of positivity and n...Continue Reading

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Citations

Apr 4, 2017·Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology·Wei LuoSilvina Masciotra
Oct 3, 2017·AIDS Research and Human Retroviruses·George AlemnjiRachel Albalak
Oct 17, 2020·Avian Pathology : Journal of the W.V.P.A·Suwarak WannaratanaSomsak Pakpinyo

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Methods Mentioned

BETA
PCR
Assay

Software Mentioned

PASER
REGA HIV - 1 subtyping tool
Stata®

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