Abstract
Rapid diagnostic tests (RDTs) are the mainstay of HIV diagnosis in the developing world but might have poor sensitivity among individuals taking antiretroviral therapy (ART). We leveraged a home-based HIV testing program linked to clinical data to compare the sensitivity of RDTs between individuals using versus not using ART. Field workers tested 6802 individuals using 2 HIV RDTs, which were compared to a single HIV immunoassay tested on dried blood spots. Approximately 5% (371/6802) tested positive by immunoassay, of whom 157 (42%) were currently on ART. The sensitivity of the Abon RDT among those never versus currently on ART was 91.6% (95% CI 88.3–94.3) and 96.6% (95% CI 88.3–94.3), respectively, and 95.4% (95% CI 92.8–97.3) versus 99.3% (95% CI 95.2–99.7) for the Advanced Quality assay. We report similar sensitivity of RDTs in ART-naïve and ART-experienced individuals, which mitigates concerns about their use among treated individuals in population-based epidemiologic surveys and those transferring care.
Highlights
The World Health Organization supports use of rapid diagnostic tests (RDTs) for diagnosis of HIV in settings where laboratory-based confirmatory assays are not available (Consolidated guidelines on HIV testing services, 2015)
There was no evidence of a difference in age between individuals on antiretroviral therapy (ART) and those who had never been on ART (P=0.19, by Wilcoxon rank sum test), but a higher proportion of those on ART were female (90% versus 70%, respectively, Pb0.001 by χ2 test)
We found that approximately 95% of HIV enzyme immunoassay-positive individuals actively taking ART in the public sector in South Africa tested positive by RDT compared to approximately 92% in those without a history of ART use
Summary
The World Health Organization supports use of rapid diagnostic tests (RDTs) for diagnosis of HIV in settings where laboratory-based confirmatory assays are not available (Consolidated guidelines on HIV testing services, 2015). RDTs allow rapid, low-cost, point-of-care diagnostic evaluation for HIV without need for complex laboratory infrastructure or extensive human resource expertise. These characteristics make them a cornerstone of HIV diagnostic in much of the developing world. Updated WHO guidelines in 2019 suggest use of 3 sequential positive tests that rely on excellent sensitivity and moderately high specificity of RDTs (World Health Organization, 1997; 2019)
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