One Swab Fits All: Performance of a Rapid, Antigen-Based SARS-CoV-2 Test Using a Nasal Swab, Nasopharyngeal Swab for Nasal Collection, and RT-PCR Confirmation from Residual Extraction Buffer

JOURNAL OF APPLIED LABORATORY MEDICINE(2022)

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摘要
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 (nasaINP), 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 nasaINP or nasal swab and tested immediately with the RAT in the individual's home by a health care provider. 500 mu L 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 nasaINP). Sensitivities of nasal samples tested on the RAT using either nasal or nasaINP 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 7days of symptom onset using nasal swabs or nasaINP. 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.
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关键词
COVID-19,POCT,SARS-CoV-2,antigen,nasal swab,rapid diagnostics
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