The clinical utility and epidemiological impact of self-testing for SARS-CoV-2 using antigen detecting diagnostics: a systematic review and meta-analysis

Introduction Self-testing for COVID-19 (C19ST) based on antigen detecting diagnostics could significantly support controlling the SARS-CoV-2 pandemic. To inform the World Health Organization in developing a C19ST guideline, we performed a systematic review and meta-analysis of the available literature. Methods We electronically searched Medline and the Web of Science core collection, performed secondary reference screening, and contacted experts for further relevant publications. Any study published between December 1, 2020 and November 30, 2021 assessing the epidemiological impact and clinical utility of C19ST was included. Study quality was evaluated using the Newcastle Ottawa Scale (NOS). The review was registered on PROSPERO (CRD42022299977). Results 11 studies only from high-income countries with an overall low quality (median of 3/9 stars on the NOS) were found. Pooled C19ST positivity was 0.2% (95% CI 0.1% to 0.4%; eight data sets) in populations where otherwise no dedicated testing would have occurred. The impact of self-testing on virus transmission was uncertain. Positive test results mainly resulted in people having to isolate without further confirmation of results (eight data sets). When testing was voluntary by study design, pooled testing uptake was 53.2% (95% CI 36.7% to 68.9%; five data sets. Outside direct health impacts, C19ST reduced quarantine duration and absenteeism from work, and made study participants feel safer. Study participants favored self-testing and were confident that they performed testing and sampling correctly. Conclusions The present data suggests that C19ST could be a valuable tool in reducing the spread of COVID-19, as it can achieve good uptake, may identify additional cases, and was generally perceived as positive by study participants. However, data was very limited and heterogenous, and further research especially in low- and middle-income countries is needed to assess the clinical utility and epidemiological impact of C19ST in more detail. CONTRIBUTIONS TO THE LITERATURE ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement The study was supported by the Ministry of Science, Research and Arts of the State of Baden-Wuerttemberg, Germany (no grant number; ) and internal funds from the Heidelberg University Hospital (no grant number; ) to CMD. Further, this project was funded by United Kingdom (UK) aid from the British people (grant number: 300341-102; Foreign, Commonwealth & Development Office (FCMO), former UK Department of International Devel-opment (DFID); [www.gov.uk/fcdo][1]), and supported by a grant from the World Health Organiza-tion (WHO; no grant number; ) and a grant from Unitaid (grant number: 2019-32-FIND MDR; ) to the Foundation of New Diagnostics (FIND; SO, AM, BE). This study was also funded by the National Science Foundation GRFP (grant number DGE1745303) to SM. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Finally, WHO used internal funds and funding provided by Unitaid (under the WHO HIV and Co-Infections/Co-Morbidities Enabler Grant [HIV&COIMS], no grant number; ), to develop the C19ST guidelines. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Data extracted from included studies and used for all analysis is publicly available under . * Ag-RDT : Antigen-based rapid diagnostic tests C19ST : COVID-19 self-testing CI : Confidence Interval GDP : Gross Domestic Product NOS : Newcastle-Ottawa Scale rRT-PCR : Real-time reverse transcriptase polymerase chain reaction WHO : Word Health Organisation [1]: http://www.gov.uk/fcdo