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.

中文翻译：

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BinaxNOW COVID-19抗原卡在大学环境中筛选无症状个体的性能特点

我们比较了Abbott BinaxNOW COVID-19抗原卡与标准逆转录PCR（RT-PCR）检测（Thermo Fisher TaqPath COVID-19 Combo kit）的性能，以检测严重的急性呼吸综合征冠状病毒2（SARS） -CoV-2）在2,645名无症状的学生中进行筛查，并在犹他大学进行筛查。通过RT-PCR在1.7％的研究参与者中检测到SARS-CoV-2 RNA。BinaxNOW识别出24种感染，但漏掉了21种通过RT-PCR检测到的感染。与RT-PCR分析相比，BinaxNOW的分析灵敏度（阳性一致性）和分析特异性（阴性一致性）分别为53.3％和100％。中位循环阈值（C _TBinaxNOW抗原结果一致的标本中的）值显着低于不一致的标本（C _T分别为17.6和29.6；P <0.001）。在病毒载量较高（C _T <23.0）的个体中，RT-PCR测定法和BinaxNOW之间观察到95.8％的阳性一致性。由于可能会产生假阴性结果，因此在使用快速抗原检测筛查无症状个体时必须小心。