Abstract
We compared the performance of the Abbott BinaxNOW COVID-19 antigen card to that of a standard reverse transcription-PCR (RT-PCR) assay (Thermo Fisher TaqPath COVID-19 Combo kit) for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 2,645 asymptomatic students presenting for screening at the University of Utah. SARS-CoV-2 RNA was detected in 1.7% of the study participants by RT-PCR. BinaxNOW identified 24 infections but missed 21 infections that were detected by RT-PCR. The analytical sensitivity (positive agreement) and analytical specificity (negative agreement) for the BinaxNOW were 53.3% and 100%, respectively, compared to the RT-PCR assay. The median cycle threshold ( C T ) value in the specimens that had concordant positive BinaxNOW antigen results was significantly lower than that of specimens that were discordant ( C T of 17.6 versus 29.6; P < 0.001). In individuals with presumably high viral loads ( C T of <23.0), a 95.8% positive agreement was observed between the RT-PCR assay and BinaxNOW. Due to the possibility of false-negative results, caution must be taken when utilizing rapid antigen testing for screening asymptomatic individuals.
Keywords: BinaxNOW COVID-19 antigen card; SARS-CoV-2; asymptomatic screening; rapid antigen tests.
【저자키워드】 SARS-CoV-2, Rapid antigen tests, asymptomatic screening, BinaxNOW COVID-19 antigen card, 【초록키워드】 COVID-19, coronavirus, Infection, severe acute respiratory syndrome Coronavirus, RT-PCR, reverse transcription-PCR, Antigen, Rapid antigen tests, Asymptomatic individuals, Asymptomatic, Viral load, cycle threshold, SARS-CoV-2 RNA, false-negative results, university, Utah, false-negative, RT-PCR assay, analytical sensitivity, TaqPath, Abbott, Analytical specificity, acute respiratory syndrome, acute respiratory syndrome coronavirus, acute respiratory syndrome coronavirus 2, caution, individual, specimen, Study participants, positive, Thermo Fisher, significantly lower, median, presenting, study participant, 【제목키워드】 COVID-19, Screening, performance, university, individual, Card, setting,