Population health and implementation outcomes of self-testing for SARS-CoV-2 using antigen detecting diagnostics: a...

COVID-19 antigen-based rapid diagnostic tests (Ag-RDTs) for self-testing (C19ST) have been widely implemented. However, evidence on population health and implementation outcomes remains limited. We systematically evaluated population health and implementation outcomes of C19ST to inform WHO guidelines and pandemic preparedness.

We conducted a systematic review and meta-analysis (PROSPERO CRD42022299977), searching Embase, MEDLINE, Web of Science, MedRxiv, clinicaltrials.gov and the Cochrane Library from Dec 1, 2020, to Oct 1, 2025. We included cohort, case-control, cross-sectional, before-and-after, and randomised studies with symptomatic and asymptomatic participants using commercially available C19ST Ag-RDTs. Primary outcomes included C19ST population health (case detection, test positivity, number needed to test (NNT)) and implementation outcomes (uptake, adherence, result reporting). Meta-analyses used binomial-normal generalised linear mixed models; study quality assessment used the JBI Quasi-Experimental Tool.

Of 19,473 records screened, 61 studies (87 datasets) with 25,288,225 participants (78% asymptomatic) were included. C19ST detected 31 (95% CI 14-65) cases per 1000 individuals, missing 14% (95% CI 1-65%) compared to molecular testing. Test positivity was 7 per 1000 tests (95% CI 3-15); false positives occurred in 0.4% (95% CI 0.2-1.0%). NNT was 75 in symptomatic and 1002 in asymptomatic individuals. Uptake, adherence, and result reporting were high, but estimates were limited by selection bias. C19ST was also reported to improve perceptions of safety, and reduce self-isolation, workplace absenteeism, and other societal disruptions, supporting the continuity of daily activities. Heterogeneity was substantial.

C19ST improves case detection and supports pandemic control with acceptable accuracy and meaningful societal benefits. These findings support the use of antigen-based self-testing as a complementary tool for a pandemic response. Studies included further highlight the limited use of standardised frameworks for evaluating population health and implementation outcomes of novel diagnostics.

Ministry of Science, Research and Arts of the State of Baden-Wuerttemberg, Germany.