Self-testing for the detection of SARS-CoV-2 infection with rapid antigen tests for people with suspected COVID-19 in the community

Stohr, J.J.J.M.; Zwart, V.F.; Goderski, G.; Meijer, A.; Nagel-Imming, C.R.S.; Kluytmans-van den Bergh, M.F.Q.; Pas, S.D.; van den Oetelaar, F.; Hellwich, M.; Gan, K.H.; Rietveld, A.; Verweij, J.J.; Murk, J.L.; van den Bijllaardt, W.; Kluytmans, J.A.J.W.

OBJECTIVES: Self-testing for COVID-19 infection with lateral flow assay SARS-CoV-2 rapid antigen detection tests (RDT), provides rapid results and could enable frequent and extensive testing in the community, thereby improving the control of SARS-CoV-2. The objective of this study was to evaluate the performance of nasal mid-turbinate self-testing using RDT for persons suspected with COVID-19 in the community. METHODS: Participants visiting a municipal SARS-CoV-2 testing centre, received self-testing kits containing either the BD Veritor System (BD-RDT) or Roche SARS-CoV-2 antigen detection test (Roche-RDT). Oro-nasopharyngeal swabs were collected from the participants for qRT-PCR testing. As a proxy for contagiousness, viral culture was performed on a selection of qRT-PCR positive samples to determine the Ct-value at which the chance of a positive culture was dropping below 0.5 (Ct-value cut-off). Sensitivity and specificity of self-testing were compared to qRT-PCR with a Ct-value below the Ct value cut-off. Determinants independently associated with a false-negative self-test result were determined. RESULTS: A total of 3,201 participants were included (BD-RDT n=1595; Roche-RDT n=1606). Sensitivity and specificity of self-testing compared to the qRT-PCR results with a Ct-value below the Ct-value cut-off was 78.4% (95% CI:73.2-83.5) and 99.4% (95%CI: 99.1-99.7) respectively. A higher age was independently associated with a false-negative self-testing result with an odds ratio of 1.024 (95%CI:1.003-1.044). CONCLUSIONS: Self-testing using currently available RDT’s has a high specificity and relatively high sensitivity to identify individuals with a high probability of contagiousness.