Okoye Nkemakonam C, Barker Adam P, Curtis Kenneth, Orlandi Richard R, Snavely Emily A, Wright Cameron, Hanson Kimberly E, Pearson Lauren N
Department of Pathology, University of Utah School of Medicine, Salt Lake City, Utah, USA.
Department of Pathology, Section of Clinical Microbiology, University of Utah School of Medicine, Salt Lake City, Utah, USA.
J Clin Microbiol. 2021 Mar 19;59(4). doi: 10.1128/JCM.03282-20.
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 ( ) value in the specimens that had concordant positive BinaxNOW antigen results was significantly lower than that of specimens that were discordant ( of 17.6 versus 29.6; < 0.001). In individuals with presumably high viral loads ( 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.
我们比较了雅培BinaxNOW新冠病毒抗原检测卡与标准逆转录聚合酶链反应（RT-PCR）检测法（赛默飞世尔TaqPath新冠病毒组合检测试剂盒）在检测2645名前来犹他大学进行筛查的无症状学生中严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的性能。通过RT-PCR在1.7%的研究参与者中检测到SARS-CoV-2 RNA。BinaxNOW检测出24例感染，但漏检了21例通过RT-PCR检测出的感染。与RT-PCR检测法相比，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%。BinaxNOW抗原检测结果呈阳性且一致的标本中的中位循环阈值（ ）值显著低于结果不一致的标本（分别为17.6和29.6； < 0.001）。在病毒载量可能较高（ <23.0）的个体中，RT-PCR检测法与BinaxNOW之间的阳性一致性为95.8%。由于存在假阴性结果的可能性，在使用快速抗原检测筛查无症状个体时必须谨慎。
