MMWR Morb Mortal Wkly Rep. 2021 Jan 1;69(5152):1642-1647. doi: 10.15585/mmwr.mm695152a3.
Antigen-based tests for SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), are inexpensive and can return results within 15 minutes (1). Antigen tests have received Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for use in asymptomatic and symptomatic persons within the first 5-12 days after symptom onset (2). These tests have been used at U.S. colleges and universities and other congregate settings (e.g., nursing homes and correctional and detention facilities), where serial testing of asymptomatic persons might facilitate early case identification (3-5). However, test performance data from symptomatic and asymptomatic persons are limited. This investigation evaluated performance of the Sofia SARS Antigen Fluorescent Immunoassay (FIA) (Quidel Corporation) compared with real-time reverse transcription-polymerase chain reaction (RT-PCR) for SARS-CoV-2 detection among asymptomatic and symptomatic persons at two universities in Wisconsin. During September 28-October 9, a total of 1,098 paired nasal swabs were tested using the Sofia SARS Antigen FIA and real-time RT-PCR. Virus culture was attempted on all antigen-positive or real-time RT-PCR-positive specimens. Among 871 (79%) paired swabs from asymptomatic participants, the antigen test sensitivity was 41.2%, specificity was 98.4%, and in this population the estimated positive predictive value (PPV) was 33.3%, and negative predictive value (NPV) was 98.8%. Antigen test performance was improved among 227 (21%) paired swabs from participants who reported one or more symptoms at specimen collection (sensitivity = 80.0%; specificity = 98.9%; PPV = 94.1%; NPV = 95.9%). Virus was isolated from 34 (46.6%) of 73 antigen-positive or real-time RT-PCR-positive nasal swab specimens, including two of 18 that were antigen-negative and real-time RT-PCR-positive (false-negatives). The advantages of antigen tests such as low cost and rapid turnaround might allow for rapid identification of infectious persons. However, these advantages need to be balanced against lower sensitivity and lower PPV, especially among asymptomatic persons. Confirmatory testing with an FDA-authorized nucleic acid amplification test (NAAT), such as RT-PCR, should be considered after negative antigen test results in symptomatic persons, and after positive antigen test results in asymptomatic persons (1).
用于检测导致 2019 冠状病毒病（COVID-19）的 SARS-CoV-2 病毒的抗原检测价格低廉，可在 15 分钟内出结果（1）。此类检测已获得美国食品和药物管理局（FDA）的紧急使用授权（EUA），可用于症状出现后 5-12 天内的无症状和有症状人群（2）。这些检测已在美国的高校和其他人群聚集场所（如疗养院、惩教和拘留设施）使用，对无症状者进行连续检测有助于早期发现病例（3-5）。然而，针对有症状和无症状者的检测性能数据有限。本研究评估了在威斯康星州的两所大学中，Sofia SARS 抗原荧光免疫分析（FIA）（Quidel 公司）与实时逆转录聚合酶链反应（RT-PCR）检测 SARS-CoV-2 在无症状和有症状者中的表现。在 9 月 28 日至 10 月 9 日期间，共有 1098 对鼻拭子同时使用 Sofia SARS 抗原 FIA 和实时 RT-PCR 进行了检测。对所有抗原阳性或实时 RT-PCR 阳性的标本均进行了病毒培养。在 871 对（79%）来自无症状参与者的配对拭子中，抗原检测的灵敏度为 41.2%，特异性为 98.4%，在该人群中估计阳性预测值（PPV）为 33.3%，阴性预测值（NPV）为 98.8%。在 227 对（21%）来自于标本采集时报告有 1 种或多种症状的参与者的配对拭子中，抗原检测的性能有所提高（灵敏度为 80.0%；特异性为 98.9%；PPV 为 94.1%；NPV 为 95.9%）。从 73 份抗原阳性或实时 RT-PCR 阳性的鼻拭子标本中分离出 34 份（46.6%）病毒，包括 18 份抗原阴性和实时 RT-PCR 阳性的标本中的 2 份（假阴性）。抗原检测的优势在于成本低、周转时间快，可能有助于快速识别传染性个体。然而，这些优势需要与较低的灵敏度和较低的 PPV相平衡，尤其是在无症状者中。对于症状性个体，在抗原检测结果为阴性后，以及无症状个体抗原检测结果为阳性后，应考虑使用 FDA 批准的核酸扩增检测（NAAT），如 RT-PCR 进行确证性检测（1）。
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