Allan-Blitz Lao-Tzu, Klausner Jeffrey D
Division of Global Health Equity, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Department of Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.
J Clin Microbiol. 2021 Sep 20;59(10):e0110721. doi: 10.1128/JCM.01107-21. Epub 2021 Aug 4.
The reported sensitivity of rapid, antigen-based diagnostics for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection varies. Few studies have evaluated rapid antigen tests in real-world settings or among large populations. Beginning October 2020, Florida offered individuals presenting for SARS-CoV-2 testing PCR testing if they tested positive by the Abbott BinaxNOW COVID-19 antigen (Ag) card, were symptomatic, or required or requested PCR testing. We compared results among individuals who received both types of tests at four publicly accessible testing sites across Florida. We calculated the positive percent agreement (PPA) between the two test types by symptom status. Subsequently, we evaluated the PPA among individuals regardless of symptoms with lower cycle threshold values (<30). Overall, 18,457 individuals were tested via both methods, of which 3,153 (17.1%) were positive by PCR. The PPA for the Abbott BinaxNOW COVID-19 Ag card using the PCR comparator was 49.2% (95% confidence interval [CI], 47.4% to 50.9%). Among symptomatic individuals the PPA was 51.9% (95% CI, 49.7% to 54.0%). When restricted to positive PCR tests with a cycle threshold value of <30, regardless of symptom status, the PPA was 75.3% (95% CI, 72.8% to 77.6%). The PPA of the Abbott BinaxNOW COVID-19 Ag card compared with PCR was lower than that previously reported. Our findings may reflect the performance of the BinaxNOW antigen test in real-world settings.
据报道，基于抗原的快速诊断方法对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染的敏感性各不相同。很少有研究在实际环境中或在大量人群中评估快速抗原检测。从2020年10月开始，佛罗里达州为前来进行SARS-CoV-2检测的个人提供聚合酶链反应（PCR）检测，如果他们通过雅培BinaxNOW新冠病毒抗原（Ag）卡检测呈阳性、有症状，或者需要或要求进行PCR检测。我们比较了在佛罗里达州四个公共场所检测点接受两种检测的个人的检测结果。我们按症状状态计算了两种检测类型之间的阳性百分一致性（PPA）。随后，我们评估了循环阈值较低（<30）的个体（无论有无症状）的PPA。总体而言，18457人通过两种方法进行了检测，其中3153人（17.1%）PCR检测呈阳性。使用PCR作为对照，雅培BinaxNOW新冠病毒Ag卡的PPA为49.2%（95%置信区间[CI]，47.4%至50.9%）。有症状个体的PPA为51.9%（95%CI，49.7%至54.0%）。当仅限于循环阈值<30的阳性PCR检测时，无论症状状态如何，PPA为75.3%（95%CI，72.8%至77.6%）。与PCR相比，雅培BinaxNOW新冠病毒Ag卡的PPA低于先前报道的值。我们的研究结果可能反映了BinaxNOW抗原检测在实际环境中的性能。
