University of California, San Francisco, San Francisco, California (J.S., C.M., D.B., G.C., V.J., D.H.).
Unidos en Salud, San Francisco, California (G.P., S.Ribeiro, J.M., J.P., D.J., D.M.).
Ann Intern Med. 2022 May;175(5):682-690. doi: 10.7326/M22-0202. Epub 2022 Mar 15.
BACKGROUND: SARS-CoV-2 rapid antigen tests are an important public health tool. OBJECTIVE: To evaluate field performance of the BinaxNOW rapid antigen test (Abbott) compared with reverse transcriptase polymerase chain reaction (RT-PCR) for detecting infection with the Omicron variant of SARS-CoV-2. DESIGN: Cross-sectional surveillance study. SETTING: Free, walk-up, outdoor, urban community testing and vaccine site led by Unidos en Salud, serving a predominantly Latinx community highly impacted by COVID-19. PARTICIPANTS: Persons seeking COVID-19 testing in January 2022. MEASUREMENTS: Simultaneous BinaxNOW and RT-PCR from nasal, cheek, and throat swabs, including cycle threshold (Ct) measures; a lower Ct value is a surrogate for higher amounts of virus. RESULTS: Among 731 persons tested with nasal swabs, there were 296 (40.5%) positive results on RT-PCR; 98.9% were the Omicron variant. BinaxNOW detected 95.2% (95% CI, 91% to 98%) of persons who tested positive on RT-PCR with a Ct value below 30, 82.1% (CI, 77% to 87%) of those who tested positive on RT-PCR with a Ct value below 35, and 65.2% (CI, 60% to 71%) of all who were positive on RT-PCR. Among 75 persons with simultaneous nasal and cheek swabs, BinaxNOW using a cheek swab failed to detect 91% (20 of 22) of specimens that were positive on BinaxNOW with a nasal swab. Among persons with simultaneous nasal and throat swabs who were positive on RT-PCR with a Ct value below 30, 42 of 49 (85.7%) were detected by nasal BinaxNOW, 23 of 49 (46.9%) by throat BinaxNOW, and 44 of 49 (89.8%) by either. LIMITATION: Participants were a cross-sectional sample from a community-based sentinel surveillance site, precluding study of viral or symptom dynamics. CONCLUSION: BinaxNOW detected persons with high SARS-CoV-2 levels during the Omicron surge, enabling rapid responses to positive test results. Cheek or throat swabs should not replace nasal swabs. As currently recommended, high-risk persons with an initial negative BinaxNOW result should have repeated testing. PRIMARY FUNDING SOURCE: University of California, San Francisco.
背景：SARS-CoV-2 快速抗原检测是一种重要的公共卫生工具。 目的：评估 BinaxNOW 快速抗原检测（Abbott）与逆转录酶聚合酶链反应（RT-PCR）在检测 SARS-CoV-2 奥密克戎变异株感染方面的现场性能。 设计：横断面监测研究。 地点：由 Unidos en Salud 领导的免费、上门、户外、城市社区检测和疫苗接种点，为受 COVID-19 严重影响的主要拉丁裔社区服务。 参与者：2022 年 1 月寻求 COVID-19 检测的人。 测量方法：同时从鼻腔、脸颊和喉咙拭子进行 BinaxNOW 和 RT-PCR，包括循环阈值（Ct）测量；Ct 值越低，表示病毒量越高。 结果：在 731 名接受鼻腔拭子检测的人中，296 人（40.5%）在 RT-PCR 上呈阳性；98.9%为奥密克戎变异株。BinaxNOW 检测到 95.2%（95%CI，91%至 98%）的 RT-PCR 阳性者 Ct 值低于 30，82.1%（CI，77%至 87%）的 RT-PCR 阳性者 Ct 值低于 35，65.2%（CI，60%至 71%）的所有 RT-PCR 阳性者。在 75 名同时接受鼻腔和脸颊拭子的人中，BinaxNOW 使用脸颊拭子未能检测到 22 份标本中的 20 份（91%），这些标本在 BinaxNOW 鼻腔拭子上为阳性。在 RT-PCR 阳性且 Ct 值低于 30 的同时接受鼻腔和喉咙拭子的人中，49 人中的 42 人（85.7%）通过鼻腔 BinaxNOW 检测到，49 人中的 23 人（46.9%）通过喉咙 BinaxNOW 检测到，49 人中的 44 人（89.8%）通过任意一种方法检测到。 局限性：参与者是来自基于社区的哨点监测站点的横断面样本，排除了对病毒或症状动态的研究。 结论：BinaxNOW 在奥密克戎激增期间检测到 SARS-CoV-2 水平较高的人群，能够对阳性检测结果做出快速反应。脸颊或喉咙拭子不能代替鼻腔拭子。如目前建议的那样，最初 BinaxNOW 结果为阴性的高风险人群应重复检测。 主要资金来源：加利福尼亚大学旧金山分校。
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