Comparing SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing/self-sampling with molecular and professional-use tests: a systematic review and meta-analysis

Abstract

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. This study aimed to inform WHO guidelines by evaluating the accuracy of COVID-19 self-testing and self-sampling coupled with professional Ag-RDT conduct and interpretation. Articles on this topic were searched until November 7th, 2022. Concordance between self-testing/self-sampling and fully professional-use Ag-RDTs was assessed using Cohen’s kappa. Bivariate meta-analysis yielded pooled performance estimates. Quality and certainty of evidence were evaluated using QUADAS-2 and GRADE tools. Among 43 studies included, twelve reported on self-testing, and 31 assessed self-sampling only. Around 49.6% showed low risk of bias. Overall concordance with professional-use Ag-RDTs was high (kappa 0.91 [95% confidence interval (CI) 0.88–0.94]). Comparing self-testing/self-sampling to molecular testing, the pooled sensitivity and specificity were 70.5% (95% CI 64.3–76.0) and 99.4% (95% CI 99.1–99.6), respectively. Higher sensitivity (i.e., 93.6% [95% CI 90.4–96.8] for Ct < 25) was estimated in subgroups with higher viral loads using Ct values as a proxy. Despite high heterogeneity among studies, COVID-19 self-testing/self-sampling exhibits high concordance with professional-use Ag-RDTs. This suggests that self-testing/self-sampling can be offered as part of COVID-19 testing strategies.Trial registration: PROSPERO: CRD42021250706.

Clinical accuracy of instrument-based SARS-CoV-2 antigen diagnostic tests: a systematic review and meta-analysis

“…This study expands on systematic reviews previously published by our group, which assessed the clinical accuracy of commercially available instrument-free and instrument-based antigen-detection rapid diagnostic tests (Ag-RDTs) for SARS-CoV-2 [ 9 , 18 , 19 ]. The methodology of our most recent analysis was applied in the present review as appropriate [ 19 ], following the standards of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist [ 20 ] (Supplementary Material, File S1 ). The study protocol was registered on PROSPERO (ID CRD42021276232) [ 21 ].…”

“…We systematically searched MEDLINE (PubMed), Web of Science, medRxiv, and bioRxiv using search terms and strategy on the basis of the earlier reviews cited above [ 9 , 18 ]. The full list of search terms was adapted from our previous reviews and is available in Supplementary Material (File S1 ) [ 9 , 19 ]. No language or geographic restrictions were applied.…”

“…The selection of studies, data extraction, and quality assessment were carried out as described previously [ 9 , 19 ]. When needed, we reached out to the study authors to request any missing information or clarification.…”

“…Statistical analysis and data synthesis were conducted as previously established [ 19 ]. In summary, we calculated the performance estimates when these outcomes were assessed in at least four studies (with ≥ 20 positive samples).…”

Enabling preprint discovery, evaluation, and analysis with Europe PMC

“…Systematic reviewers can export all or a selection of search results in various data formats including XML and CSV. As a result, Europe PMC adoption as a search engine for preprints in systematic reviews of the research literature has been referenced by numerous studies [62][63][64][65][66][67][68][69][70][71].…”