MMWR Morb Mortal Wkly Rep. 2021 Jan 22;70(3):100-105. doi: 10.15585/mmwr.mm7003e3.
Rapid antigen tests, such as the Abbott BinaxNOW COVID-19 Ag Card (BinaxNOW), offer results more rapidly (approximately 15-30 minutes) and at a lower cost than do highly sensitive nucleic acid amplification tests (NAATs) (1). Rapid antigen tests have received Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for use in symptomatic persons (2), but data are lacking on test performance in asymptomatic persons to inform expanded screening testing to rapidly identify and isolate infected persons (3). To evaluate the performance of the BinaxNOW rapid antigen test, it was used along with real-time reverse transcription-polymerase chain reaction (RT-PCR) testing to analyze 3,419 paired specimens collected from persons aged ≥10 years at two community testing sites in Pima County, Arizona, during November 3-17, 2020. Viral culture was performed on 274 of 303 residual real-time RT-PCR specimens with positive results by either test (29 were not available for culture). Compared with real-time RT-PCR testing, the BinaxNOW antigen test had a sensitivity of 64.2% for specimens from symptomatic persons and 35.8% for specimens from asymptomatic persons, with near 100% specificity in specimens from both groups. Virus was cultured from 96 of 274 (35.0%) specimens, including 85 (57.8%) of 147 with concordant antigen and real-time RT-PCR positive results, 11 (8.9%) of 124 with false-negative antigen test results, and none of three with false-positive antigen test results. Among specimens positive for viral culture, sensitivity was 92.6% for symptomatic and 78.6% for asymptomatic individuals. When the pretest probability for receiving positive test results for SARS-CoV-2 is elevated (e.g., in symptomatic persons or in persons with a known COVID-19 exposure), a negative antigen test result should be confirmed by NAAT (1). Despite a lower sensitivity to detect infection, rapid antigen tests can be an important tool for screening because of their quick turnaround time, lower costs and resource needs, high specificity, and high positive predictive value (PPV) in settings of high pretest probability. The faster turnaround time of the antigen test can help limit transmission by more rapidly identifying infectious persons for isolation, particularly when used as a component of serial testing strategies.
快速抗原检测，如 Abbott BinaxNOW COVID-19 Ag 卡（BinaxNOW），与高度敏感的核酸扩增检测（NAAT）相比，提供结果的速度更快（约 15-30 分钟）且成本更低（1）。快速抗原检测已获得美国食品和药物管理局（FDA）的紧急使用授权（EUA），可用于有症状的人（2），但缺乏无症状人群的检测性能数据，无法提供信息来扩大筛查检测，以便快速识别和隔离感染人群（3）。为评估 BinaxNOW 快速抗原检测的性能，在 2020 年 11 月 3 日至 17 日，在亚利桑那州皮马县的两个社区检测点，对 303 份实时 RT-PCR 检测结果阳性的标本中的 274 份进行了病毒培养，并对来自 2 个社区检测点、年龄≥10 岁的 3419 名有症状和无症状个体采集的配对标本进行了检测。实时 RT-PCR 检测结果阳性的标本中，274 份进行了病毒培养，BinaxNOW 抗原检测对有症状个体的标本敏感性为 64.2%，对无症状个体的标本敏感性为 35.8%，两组标本的特异性均接近 100%。病毒培养从 274 份标本中分离出 96 份（35.0%），包括 85 份（57.8%）抗原和实时 RT-PCR 检测均阳性的标本、11 份（8.9%）抗原检测阴性而实时 RT-PCR 检测阳性的标本和 3 份抗原检测阳性而实时 RT-PCR 检测阴性的标本。在病毒培养阳性的标本中，有症状个体和无症状个体的敏感性分别为 92.6%和 78.6%。当 SARS-CoV-2 阳性检测结果的先验概率较高（例如，在有症状的个体或有已知 COVID-19 接触史的个体中）时，阴性抗原检测结果应通过 NAAT 来确认（1）。尽管快速抗原检测对感染的检测敏感性较低，但由于其检测周转时间较短、成本和资源需求较低、特异性较高以及在高先验概率的情况下阳性预测值（PPV）较高，因此仍然是一种重要的筛查工具。抗原检测更快的检测周转时间有助于通过更快地识别传染性个体进行隔离来限制传播，特别是当作为连续检测策略的一部分时。
