The Infectious Diseases Society of America Guidelines on the Diagnosis of Coronavirus Disease 2019 (COVID-19): Antigen Testing
The Infectious Diseases Society of America Guidelines on the Diagnosis of Coronavirus Disease 2019 (COVID-19): Antigen Testing
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DOI：
10.1093/cid/ciab557
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发表时间：
2021-10-22
影响因子：
11.8
通讯作者：
Mustafa, Reem A.
中科院分区：
文献类型：
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作者：
Hanson, Kimberly E.;Altayar, Osama;Mustafa, Reem A.
旨在检测 SARS-CoV-2 蛋白抗原的免疫测定现已上市。最广泛使用的测试是快速侧流检测，可在大约 15 分钟内生成结果，以便在护理点进行诊断。更高通量、基于实验室的 SARS-CoV-2 抗原 (Ag) 检测也已开发出来。然而，SARS-CoV-2 Ag 检测的总体准确性尚未明确。美国传染病学会 (IDSA) 召集了一个专家小组，对文献进行系统审查，并制定与 SARS-CoV-2 Ag 检测相关的最佳实践指南。本指南是 IDSA 制定的一系列快速、频繁更新的 COVID-19 诊断指南中的第三部分。 IDSA 的目标是制定基于证据的建议或建议，协助临床医生、临床实验室、患者、公共卫生当局、管理人员和政策制定者做出与在医疗和非医疗环境中最佳使用 SARS-CoV-2 Ag 检测相关的决策。由传染病临床医生、临床微生物学家和系统文献综述专家组成的多学科小组确定了与使用 SARS-CoV-2 Ag 检测相关的临床问题并确定了优先顺序。使用建议评估、制定和评价分级 (GRADE) 方法来评估证据的确定性并提出测试建议。专家组就 5 项诊断建议达成一致。这些建议涉及有症状和无症状个体的抗原检测，以及评估单次检测与重复检测策略。获得紧急使用授权的美国食品和药物管理局 SARS-CoV-2 Ag 检测的临床表现数据大多仅限于单次、一次性检测，而以标准核酸扩增检测 (NAAT) 作为参考标准。与参考 NAAT 方法相比，快速 Ag 检测具有高特异性和低至中等灵敏度。抗原测试的敏感性在很大程度上取决于病毒载量，有症状的个体与无症状的个体之间观察到的差异以及症状出现后的测试时间。基于这些观察，快速逆转录酶聚合酶链反应 (RT-PCR) 或基于实验室的 NAAT 仍然是诊断 SARS-CoV-2 感染的首选诊断方法。然而，当分子检测不易获得或在逻辑上不可行时，Ag 检测可以帮助识别一些感染 SARS-CoV-2 的个体。支持使用银测试的现有证据的总体质量被评为非常低到中等。
Immunoassays designed to detect SARS-CoV-2 protein antigens are now commercially available. The most widely used tests are rapid lateral flow assays that generate results in similar to 15 minutes for diagnosis at the point-of-care. Higher throughput, laboratory-based SARS-CoV-2 antigen (Ag) assays have also been developed. The overall accuracy of SARS-CoV-2 Ag tests, however, is not well defined. 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 the third in a series of rapid, frequently updated COVID-19 diagnostic guidelines developed by 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. Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations. The panel agreed on 5 diagnostic recommendations. These recommendations address Ag testing in symptomatic and asymptomatic individuals as well as assess single versus repeat testing strategies. Data on the clinical performance of US Food and Drug Administration SARS-CoV-2 Ag tests with Emergency Use Authorization are mostly limited to single, one-time testing versus standard nucleic acid amplification testing (NAAT) as the reference standard. Rapid Ag tests have high specificity and low to modest sensitivity compared with reference NAAT methods. Antigen test sensitivity is heavily dependent on viral load, with differences observed between symptomatic compared with asymptomatic individuals and the time of testing post-onset of symptoms. Based on these observations, rapid reverse transcriptase-polymerase chain reaction (RT-PCR) or laboratory-based NAAT remain the diagnostic methods of choice for diagnosing SARS-CoV-2 infection. However, when molecular testing is not readily available or is logistically infeasible, Ag testing can help identify some individuals with SARS-CoV-2 infection. The overall quality of available evidence supporting use of Ag testing was graded as very low to moderate.