Performance of SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing and self-sampling in comparison to molecular and professional-use antigen tests: A systematic review and meta-analysis

Abstract

Abstract Purpose Self-testing is an effective tool to bridge the testing gap for several infectious diseases; however, its performance in detecting SARS-CoV-2 using antigen-detection rapid diagnostic tests (Ag-RDTs) has not been systematically reviewed. To inform WHO guideline development, we evaluated the accuracy of COVID-19 self-testing and/or self-sampling using Ag-RDTs. Methods: We searched multiple databases for articles evaluating the accuracy of COVID-19 self-testing or self-sampling through November 7th, 2022. Cohen’s kappa was estimated to assess concordance between self-testing/self-sampling and fully professional-use Ag-RDT results. Bivariate meta-analysis was performed to obtain pooled performance estimates compared to molecular testing. The QUADAS-2 and GRADE tools were used to evaluate quality and certainty of evidence. Results: Among 43 studies included in the review, twelve reported on self-testing, while 31 studies assessed self-sampling only. The risk of bias was low in 49.6% of the studies. Overall concordance with professional-use Ag-RDTs (n = 7 datasets) was high (kappa 0.92 [95% confidence interval (CI) 0.89 to 0.95]). Overall pooled sensitivity and specificity of Ag-RDT testing using self-testing/self-sampling (n = 54 datasets) was 70.5% (95% CI 64.3 to 76.0) and 99.4% (95% CI 99.1–99.6), respectively. Conclusion: Despite high heterogeneity among studies, COVID-19 self-testing/self-sampling exhibits high concordance with professional-use Ag-RDTs. This suggest that self-testing/self-sampling can be offered as part of COVID-19 testing strategies. Trial registration PROSPERO: CRD42021250706