Abstract
Background: Point-of-care SARS-CoV-2 antigen tests have great potential to help combat the COVID-19 pandemic. In the performance of a rapid, antigen-based SARS-CoV-2 test (RAT), our study had 3 main objectives: to determine the accuracy of nasal swabs, the accuracy of using nasopharyngeal swabs for nasal collection (nasalNP), and the effectiveness of using residual extraction buffer for real-time reverse-transcriptase PCR (RT-PCR) confirmation of positive RAT (rPan).
Methods: Symptomatic adults recently diagnosed with COVID-19 in the community were recruited into the study. Nasal samples were collected using either a nasalNP or nasal swab and tested immediately with the RAT in the individual’s home by a health care provider. 500 µL of universal transport media was added to the residual extraction buffer after testing and sent to the laboratory for SARS-CoV-2 testing using RT-PCR. Parallel throat swabs tested with RT-PCR were used as the reference comparators.
Results: One hundred and fifty-five individuals were included in the study (99 nasal swabs, 56 nasalNP). Sensitivities of nasal samples tested on the RAT using either nasal or nasalNP were 89.0% [95% confidence interval (CI) 80.7%-94.6%] and 90.2% (95% CI 78.6%-96.7%), respectively. rPan positivity agreement compared to throat RT-PCR was 96.2%.
Conclusions: RAT reliably detect SARS-CoV-2 from symptomatic adults in the community presenting within 7 days of symptom onset using nasal swabs or nasalNP. High agreement with rPan can avoid the need for collecting a second swab for RT-PCR confirmation or testing of variants of concern from positive RAT in this population.
Keywords: COVID-19; POCT; SARS-CoV-2; antigen; nasal swab; rapid diagnostics.
【저자키워드】 COVID-19, SARS-CoV-2, Antigen, POCT, nasal swab, rapid diagnostics., 【초록키워드】 Health care, COVID-19 pandemic, variants of concern, nasal, RT-PCR, diagnostics, variants, Laboratory, Antigen, Nasopharyngeal swab, point-of-care, Health, Accuracy, SARS-CoV-2 testing, Transport media, nasopharyngeal swabs, POCT, Effectiveness, Community, Swab, antigen tests, SARS-CoV-2 antigen, nasal swab, Care, Nasal sample, care provider, symptom onset, confidence interval, 95% CI, 95% confidence interval, individual, help, symptomatic adults, sensitivities, positive, throat swab, nasal swabs, SARS-CoV-2 test, nasal samples, reverse-transcriptase PCR, extraction buffer, tested, detect, collected, recruited, were used, added, determine, presenting, diagnosed with COVID-19, symptomatic adult, 【제목키워드】 Test, Rapid, performance, confirmation, extraction, residual, Collection,