• Katy Jl Bell, Yuyang Li, Ellie Medcalf, and Deonna Ackermann.
• School of Public Health, the University of Sydney, Sydney, NSW.
• Med. J. Aust. 2023 Dec 11; 219 (11): 551558551-558.

ObjectivesTo review evaluations of the diagnostic accuracy of coronavirus disease 2019 (COVID-19) rapid antigen tests (RATs) approved by the Therapeutic Goods Administration (TGA) for self-testing by ambulatory people in Australia; to compare these estimates with values reported by test manufacturers.Study DesignSystematic review of publications in any language that reported cross-sectional, case-control, or cohort studies in which the participants were ambulatory people in the community or health care workers in hospitals in whom severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was suspected, and the results of testing self-collected biological samples with a TGA-approved COVID-19 RAT were compared with those of reverse transcription-polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Estimates of diagnostic accuracy (sensitivity, specificity) were checked and compared with manufacturer estimates published on the TGA website.Data SourcesPublications (to 1 September 2022) identified in the Cochrane COVID-19 Study Register and the World Health Organization COVID-19 research database. Information on manufacturer diagnostic accuracy evaluations was obtained from the TGA website.Data SynthesisTwelve publications that reported a total of eighteen evaluations of eight RATs approved by the TGA for self-testing (manufacturers: All Test, Roche, Flowflex, MP Biomedicals, Clungene, Panbio, V-Chek, Whistling) were identified. Five studies were undertaken in the Netherlands, two each in Germany and the United States, and one each in Denmark, Belgium, and Canada; test sample collection was unsupervised in twelve studies, and supervised by health care workers or researchers in six. Estimated sensitivity with unsupervised sample collection ranged from 20.9% (MP Biomedicals) to 74.3% (Roche), and with supervised collection from 7.7% (V-Chek) to 84.4% (Panbio); the estimates were between 8.2 and 88 percentage points lower than the values reported by the manufacturers. Test specificity was high for all RATs (97.9-100%).ConclusionsThe risk of false negative results when using COVID-19 RATs for self-testing may be considerably higher than apparent in manufacturer reports on the TGA website, with implications for the reliability of these tests for ruling out infection.© 2023 The Authors. Medical Journal of Australia published by John Wiley & Sons Australia, Ltd on behalf of AMPCo Pty Ltd.

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