Department of Pathology, Stanford University, Stanford, California, USA.
Chan Zuckerberg Biohub, San Francisco, California, USA.
J Infect Dis. 2021 Apr 8;223(7):1139-1144. doi: 10.1093/infdis/jiaa802.
We evaluated the performance of the Abbott BinaxNOW rapid antigen test for coronavirus disease 2019 (Binax-CoV2) to detect virus among persons, regardless of symptoms, at a public plaza site of ongoing community transmission. Titration with cultured severe acute respiratory syndrome coronavirus 2 yielded a human observable threshold between 1.6 × 104-4.3 × 104 viral RNA copies (cycle threshold [Ct], 30.3-28.8). Among 878 subjects tested, 3% (26 of 878) were positive by reverse-transcription polymerase chain reaction, of whom 15 of 26 had a Ct <30, indicating high viral load; of these, 40% (6 of 15) were asymptomatic. Using this Ct threshold (<30) for Binax-CoV2 evaluation, the sensitivity of Binax-CoV2 was 93.3% (95% confidence interval, 68.1%-99.8%) (14 of 15) and the specificity was 99.9% (99.4%-99.9%) (855 of 856).
我们评估了雅培 BinaxNOW 快速抗原检测对新型冠状病毒病（Binax-CoV2）的检测性能，以检测无症状人群在社区传播进行中的公共广场地点的病毒。用培养的严重急性呼吸综合征冠状病毒 2 进行滴定，得到人类可观察到的阈值在 1.6×104-4.3×104 病毒 RNA 拷贝（循环阈值[Ct]，30.3-28.8）之间。在 878 名接受检测的受试者中，3%（26/878）通过逆转录聚合酶链反应呈阳性，其中 26 名中有 15 名 Ct<30，表明病毒载量高；其中，40%（6/15）无症状。使用此 Ct 阈值（<30）进行 Binax-CoV2 评估，Binax-CoV2 的灵敏度为 93.3%（95%置信区间，68.1%-99.8%）（15 例中的 14 例），特异性为 99.9%（99.4%-99.9%）（856 例中的 855 例）。
