Successful containment strategies for the SARS-CoV-2 pandemic will depend on reliable diagnostic assays. Point-of-care antigen tests (POCT) may provide an alternative to time-consuming PCR tests to rapidly screen for acute infections on site. Here, we evaluated two SARS-CoV-2 antigen tests: the STANDARD™ F COVID-19 Ag FIA (FIA) and the SARS-CoV-2 Rapid Antigen Test (RAT). For diagnostic assessment, we used a large set of PCR-positive and PCR-negative respiratory swabs from asymptomatic and symptomatic patients and health care workers in the setting of two University Hospitals in Munich, Germany, i.e. emergency rooms, patient care units or employee test centers. For FIA, overall clinical sensitivity and specificity were 45.4% (n = 381) and 97.8% (n = 360), respectively, and for RAT, 50.3% (n = 445) and 97.7% (n = 386), respectively. For primary diagnosis of asymptomatic and symptomatic individuals, diagnostic sensitivities were 60.9% (FIA) (n = 189) and 64.5% (RAT) (n = 256). This questions these tests’ utility for the reliable detection of acute SARS-CoV-2-infected individuals, in particular in high-risk settings. We support the proposal that convincing high-quality outcome data on the impact of false-negative and false-positive antigen test results need to be obtained in a POCT setting. Moreover, the efficacy of alternative testing strategies to complement PCR assays must be evaluated by independent laboratories, prior to widespread implementation in national and international test strategies.

SARS-CoV-2大流行的成功遏制策略将取决于可靠的诊断方法。即时护理抗原测试（POCT）可以替代耗时的PCR测试，以快速筛查现场的急性感染。在这里，我们评估了两种SARS-CoV-2抗原测试：STANDARD™F COVID-19 Ag FIA（FIA）和SARS-CoV-2快速抗原测试（RAT）。为了进行诊断评估，我们在德国慕尼黑的两家大学医院中使用了无症状和有症状患者以及医护人员的大量PCR阳性和PCR阴性呼吸拭子，即急诊室，患者护理单位或员工测试中心。对于FIA，总体临床敏感性和特异性分别为45.4％（n  = 381）和97.8％（n =分别为360和RAT，分别为50.3％（n  = 445）和97.7％（n  = 386）。对于无症状和有症状个体的初步诊断，诊断敏感性为60.9％（FIA）（n  = 189）和64.5％（RAT）（n = 256）。这质疑了这些测试对可靠检测急性SARS-CoV-2感染个体的效用，尤其是在高风险环境中。我们支持这样的建议，即需要在POCT设置中获得令人信服的关于假阴性和假阳性抗原检测结果的高质量结果数据。此外，在国家和国际测试策略中广泛实施之前，必须由独立实验室评估补充PCR分析的替代测试策略的功效。