The journal of applied laboratory medicine · 2022
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.
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Stokes William, Berenger Byron M, Scott Brittney, Szelewicki Jonas, Singh Takshveer, Portnoy Danielle, Turnbull LeeAnn, Pabbaraju Kanti, Shokoples Sandy, Wong Anita A, Gill Kara, Hu Jia, Tipples Graham
Аннотация
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.
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.