COVID‐19 rapid antigen tests approved for self‐testing in Australia: published diagnostic test accuracy studies and manufacturer‐supplied information. A systematic review

Abstract

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.