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

Background Most 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. Methods PubMed 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). Results The 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 I 2 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. Conclusion The 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.