Abstract：
Immunoassays designed to detect SARS-CoV-2 protein antigens (Ag) are commonly used to diagnose COVID-19. The most widely used tests are lateral flow assays that generate results in approximately 15 minutes for diagnosis at the point-of-care. Higher throughput, laboratory-based SARS-CoV-2 Ag assays have also been developed. The number of commercially available SARS-CoV-2 Ag detection tests has increased rapidly, as has the COVID-19 diagnostic literature. The Infectious Diseases Society of America (IDSA) convened an expert panel to perform a systematic review of the literature and develop best-practice guidance related to SARS-CoV-2 Ag testing. This guideline is an update to the third in a series of frequently updated COVID-19 diagnostic guidelines developed by the IDSA. IDSA\'s goal was to develop evidence-based recommendations or suggestions that assist clinicians, clinical laboratories, patients, public health authorities, administrators, and policymakers in decisions related to the optimal use of SARS-CoV-2 Ag tests in both medical and nonmedical settings. A multidisciplinary panel of infectious diseases clinicians, clinical microbiologists, and experts in systematic literature review identified and prioritized clinical questions related to the use of SARS-CoV-2 Ag tests. A review of relevant, peer-reviewed published literature was conducted through 1 April 2022. Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations. The panel made 10 diagnostic recommendations that address Ag testing in symptomatic and asymptomatic individuals and assess single versus repeat testing strategies. US Food and Drug Administration (FDA) SARS-CoV-2 Ag tests with Emergency Use Authorization (EUA) have high specificity and low to moderate sensitivity compared with nucleic acid amplification testing (NAAT). Ag test sensitivity is dependent on the presence or absence of symptoms and, in symptomatic patients, on timing of testing after symptom onset. In most cases, positive Ag results can be acted upon without confirmation. Results of point-of-care testing are comparable to those of laboratory-based testing, and observed or unobserved self-collection of specimens for testing yields similar results. Modeling suggests that repeat Ag testing increases sensitivity compared with testing once, but no empirical data were available to inform this question. Based on these observations, rapid RT-PCR or laboratory-based NAAT remain the testing methods of choice for diagnosing SARS-CoV-2 infection. However, when timely molecular testing is not readily available or is logistically infeasible, Ag testing helps identify individuals with SARS-CoV-2 infection. Data were insufficient to make a recommendation about the utility of Ag testing to guide release of patients with COVID-19 from isolation. The overall quality of available evidence supporting use of Ag testing was graded as very low to moderate.
摘要：
背景：用于检测SARS-CoV-2蛋白抗原（Ag）的免疫测定通常用于诊断COVID-19。最广泛使用的测试是侧流测定,其在大约15分钟内产生结果用于在护理点诊断。更高的吞吐量，还开发了基于实验室的SARS-CoV-2Ag检测方法。市售的SARS-CoV-2Ag检测试验数量迅速增加,COVID-19诊断文献也是如此。美国传染病学会（IDSA）召集了一个专家小组，对文献进行了系统的审查，并制定了与SARS-CoV-2Ag测试相关的最佳实践指南。该指南是对IDSA制定的一系列不断更新的COVID-19诊断指南中的第三项的更新。
目的：IDSA的目标是制定基于证据的建议或帮助临床医生的建议，临床实验室,病人,公共卫生当局,与在医疗和非医疗环境中最佳使用SARS-CoV-2Ag测试相关的决策的管理者和决策者。
方法：传染病临床医生的多学科小组，临床微生物学家和专家在系统文献综述中确定并优先考虑与使用SARS-CoV-2Ag测试相关的临床问题。相关审查，同行评审的已发表文献进行到2022年4月1日.建议评估的分级，使用开发和评估（GRADE）方法来评估证据的确定性并提出测试建议。
结果：专家组提出了十项诊断建议。这些建议解决了有症状和无症状个体的Ag测试，并评估了单次与重复测试策略。
结论：与核酸扩增检测（NAAT）相比，美国食品药品监督管理局（FDA）的SARS-CoV-2Ag检测与紧急使用授权（EUA）相比具有高特异性和低至中等敏感性。Ag测试灵敏度取决于症状的存在或不存在，在有症状的患者中，症状发作后的测试时间。相比之下,Ag测试具有很高的特异性，and,在大多数情况下,阳性Ag结果可以在没有确认的情况下采取行动。即时测试的结果与实验室测试的结果相当，和观察到的或未观察到的自我收集的标本进行测试产生类似的结果。建模表明，与一次测试相比，重复Ag测试增加了灵敏度，但没有经验数据可以解释这个问题。基于这些观察,快速RT-PCR或基于实验室的NAAT仍然是诊断SARS-CoV-2感染的首选测试方法。然而,当及时的分子检测不容易获得或在逻辑上不可行时，Ag检测有助于识别SARS-CoV-2感染的个体。数据不足以就Ag检测指导COVID-19患者从隔离中释放的实用性提出建议。支持使用Ag测试的可用证据的总体质量被分级为非常低至中等。
目的：IDSA的目标是制定基于证据的建议或帮助临床医生的建议，临床实验室,病人,公共卫生当局,与在医疗和非医疗环境中最佳使用SARS-CoV-2Ag测试相关的决策的管理者和决策者。
方法：传染病临床医生的多学科小组，临床微生物学家和专家在系统文献综述中确定并优先考虑与使用SARS-CoV-2Ag测试相关的临床问题。相关审查，同行评审的已发表文献进行到2022年4月1日.建议评估的分级，使用开发和评估（GRADE）方法来评估证据的确定性并提出测试建议。
结果：专家组提出了十项诊断建议。这些建议解决了有症状和无症状个体的Ag测试，并评估了单次与重复测试策略。
结论：与核酸扩增检测（NAAT）相比，美国食品药品监督管理局（FDA）的SARS-CoV-2Ag检测与紧急使用授权（EUA）相比具有高特异性和低至中等敏感性。Ag测试灵敏度取决于症状的存在或不存在，在有症状的患者中，症状发作后的测试时间。相比之下,Ag测试具有很高的特异性，and,在大多数情况下,阳性Ag结果可以在没有确认的情况下采取行动。即时测试的结果与实验室测试的结果相当，和观察到的或未观察到的自我收集的标本进行测试产生类似的结果。建模表明，与一次测试相比，重复Ag测试增加了灵敏度，但没有经验数据可以解释这个问题。基于这些观察,快速RT-PCR或基于实验室的NAAT仍然是诊断SARS-CoV-2感染的首选测试方法。然而,当及时的分子检测不容易获得或在逻辑上不可行时，Ag检测有助于识别SARS-CoV-2感染的个体。数据不足以就Ag检测指导COVID-19患者从隔离中释放的实用性提出建议。支持使用Ag测试的可用证据的总体质量被分级为非常低至中等。
