Background Rapid antigen diagnostic tests (Ag-RDTs) are the most widely used point-of-care tests for detecting SARS-CoV-2 infection. Since the accuracy may have altered by changes in SARS-CoV-2 epidemiology, indications for testing, sampling and testing procedures, and roll-out of COVID-19 vaccination, we evaluated the performance of three prevailing SARS-CoV-2 Ag-RDTs. Methods In this cross-sectional study, we consecutively enrolled individuals aged >16 years presenting for SARS-CoV-2 testing at three Dutch public health service COVID-19 test sites. In the first phase, participants underwent either BD-Veritor System (Becton Dickinson ), PanBio (Abbott ), or SD-Biosensor (Roche Diagnostics ) testing with routine sampling procedures. In a subsequent phase, participants underwent SD-Biosensor testing with a less invasive sampling method (combined oropharyngeal-nasal [OP-N] swab). Diagnostic accuracies were assessed against molecular testing. Results Six thousand nine hundred fifty-five of 7005 participants (99%) with results from both an Ag-RDT and a molecular reference test were analysed. SARS-CoV-2 prevalence and overall sensitivities were 13% (188/1441) and 69% (129/188, 95% CI 62–75) for BD-Veritor, 8% (173/2056) and 69% (119/173, 61–76) for PanBio, and 12% (215/1769) and 74% (160/215, 68–80) for SD-Biosensor with routine sampling and 10% (164/1689) and 75% (123/164, 68–81) for SD-Biosensor with OP-N sampling. In those symptomatic or asymptomatic at sampling, sensitivities were 72–83% and 54–56%, respectively. Above a viral load cut-off (≥5.2 log 10 SARS-CoV-2 E-gene copies/mL), sensitivities were 86% (125/146, 79–91) for BD-Veritor, 89% (108/121, 82–94) for PanBio, and 88% (160/182, 82–92) for SD-Biosensor with routine sampling and 84% (118/141, 77–89) with OP-N sampling. Specificities were >99% for all tests in most analyses. Sixty-one per cent of false-negative Ag-RDT participants returned for testing within 14 days (median: 3 days, interquartile range 3) of whom 90% tested positive. Conclusions Overall sensitivities of three SARS-CoV-2 Ag-RDTs were 69–75%, increasing to ≥86% above a viral load cut-off. The decreased sensitivity among asymptomatic participants and high positivity rate during follow-up in false-negative Ag-RDT participants emphasise the need for education of the public about the importance of re-testing after an initial negative Ag-RDT should symptoms develop. For SD-Biosensor, the diagnostic accuracy with OP-N and deep nasopharyngeal sampling was similar; adopting the more convenient sampling method might reduce the threshold for professional testing. Supplementary Information The online version contains supplementary material available at 10.1186/s12916-022-02300-9.
【저자키워드】 COVID-19, SARS-CoV-2, Rapid antigen tests, Diagnostic accuracy, 【초록키워드】 public health, cross-sectional, SARS-COV-2 infection, diagnostic test, diagnostic, Symptom, Antigen, Prevalence, sensitivity, Diagnostic accuracy, cross-sectional study, Viral, Asymptomatic, COVID-19 vaccination, Accuracy, SARS-CoV-2 testing, Viral load, nasopharyngeal, diagnostic tests, symptomatic, Rapid, sampling, Follow-up, Swab, molecular, point-of-care test, threshold, Ag-RDT, E-gene, SARS-CoV-2 epidemiology, RDTs, COVID-19 test, Abbott, public health service, interquartile range, reference test, supplementary material, 95% CI, individual, indication, Ag-RDTs, participant, false, sensitivities, cut-off, positive, Becton Dickinson, PanBio, point-of-care tests, Roche Diagnostics, Specificities, System, invasive, initial, log, Result, enrolled, tested, develop, subsequent, evaluated, nine, analysed, less, changes in, reduce, presenting, analyses, returned, Above, false-negative Ag-RDT, were assessed, 【제목키워드】 cross-sectional, diagnostic, detection, Antigen, Diagnostic accuracy, Accuracy, General population,