Evaluation of operational characteristics and performance of HIV rapid diagnostic tests (RDTs): Systematic review and meta-analysis of the literature from 2012 to 2020

Abstract

AbstractBackgroundMost countries have rolled out HIV Rapid diagnostic tests (RDTs) due to their significant advantages over laboratory-based serological testing. These advantages are lower cost, ease of use, interpretation speed, and relatively high acceptability; the HIV diagnostic landscape has evolved fast, and newer technologies have been developed and deployed. Given the many options available, selecting an HIV rapid diagnostic test for a particular clinical program, self-test, or research setting can be daunting without the precise knowledge of their performance characteristics. This systematic review and meta-analysis aimed to compare the field diagnostic performance of available HIV rapid test kits, cost-effectiveness, ease of use, and acceptability.MethodsPubMed and Web of Science were searched for publications on rapid HIV tests using blood specimens. We then performed a meta-analysis and systematic analysis to quantitatively and qualitatively evaluate the diagnostic performance of rapid HIV tests compared with the western blot (WB), enzyme-linked immunosorbent assay (ELISA), or an HIV diagnostic algorithm in terms of pooled sensitivity, specificity, area under the summary receiver operating characteristic (SROC) curve, and diagnostic odds ratio (DOR).ResultsThe meta-analysis for the diagnostic test included 26 studies for diagnostic accuracy, while the qualitative analysis included 15 studies. On average, the RDT sensitivities were 99%; [95% CI=0.99-100%], while specificity was optimal at 100%; [95% CI=99%-100%]. The diagnostic odds ratio estimates that a single test performed better than a dual test: dual test DOR=44612.33 and single test DOR=14323.1. The impact of unobserved heterogeneity using the quantity I2 for sensitivity was 99.47%, while that for specificity was 99.96, indicating significant heterogeneity and justifying stratified analysis of the selected studies. The diagnostic test from Unigold had the best-pooled sensitivity, specificity, and diagnostic odds ratio at 99%, 99.35%, and 2896.667, respectively. Qualitative data indicate shorter time to results is preferred by both the clients and health care providers.ConclusionThe average of the RDT sensitivities for diagnostic accuracy were 99% (95% CI=0.99-100%), while specificity was optimal at 100%; 95% CI=99-100. The diagnostic odds ratio was DOR=44612 (95% CI=14323-138954), thus indicating better RDT test performance. The performance of single test kits in HIV diagnosis was better than those for dual tests.