Abstract：
Accurate molecular diagnostic tests are necessary for confirming a diagnosis of coronavirus disease 2019 (COVID-19) and for identifying asymptomatic carriage of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The number of available SARS-CoV-2 nucleic acid detection tests continues to increase as does the COVID-19 diagnostic literature. Thus, the Infectious Diseases Society of America (IDSA) developed an evidence-based diagnostic guideline to assist clinicians, clinical laboratorians, patients, and policymakers in decisions related to the optimal use of SARS-CoV-2 nucleic acid amplification tests. In addition, we provide a conceptual framework for understanding molecular diagnostic test performance, discuss nuances of test result interpretation in a variety of practice settings, and highlight important unmet research needs related to COVID-19 diagnostic testing. IDSA convened a multidisciplinary panel of infectious diseases clinicians, clinical microbiologists, and experts in systematic literature review to identify and prioritize clinical questions and outcomes related to the use of SARS-CoV-2 molecular diagnostics. 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 12 diagnostic recommendations. Access to accurate SARS-CoV-2 nucleic acid testing is critical for patient care, hospital infection prevention, and the public health response to COVID-19 infection. Information on the clinical performance of available tests continues to grow, but the quality of evidence of the current literature to support this updated molecular diagnostic guideline remains moderate to very low. Recognizing these limitations, the IDSA panel weighed available diagnostic evidence and recommends nucleic acid testing for all symptomatic individuals suspected of having COVID-19. In addition, testing is suggested for asymptomatic individuals with known or suspected contact with a COVID-19 case when the results will impact isolation/quarantine/personal protective equipment (PPE) usage decisions. Evidence in support of rapid testing and testing of upper respiratory specimens other than nasopharyngeal swabs, which offer logistical advantages, is sufficient to warrant conditional recommendations in favor of these approaches.
摘要：
准确的分子诊断测试对于确认2019年冠状病毒病（COVID-19）的诊断和识别无症状携带严重急性呼吸综合征冠状病毒2（SARS-CoV-2）是必要的。可用的SARS-CoV-2核酸检测测试的数量继续增加，COVID-19诊断文献也是如此。因此，美国传染病学会（IDSA）制定了基于证据的诊断指南，以帮助临床医生，临床实验室，病人,以及与SARS-CoV-2核酸扩增测试的最佳使用相关的决策的决策者。此外,我们提供了一个理解分子诊断测试性能的概念框架，讨论各种实践设置中测试结果解释的细微差别，并强调与COVID-19诊断测试相关的重要未满足的研究需求。IDSA召集了一个多学科的传染病临床医生小组，临床微生物学家，和专家进行系统文献综述，以确定和优先考虑与使用SARS-CoV-2分子诊断相关的临床问题和结果。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。专家组同意12项诊断建议。获得准确的SARS-CoV-2核酸检测对患者护理至关重要，医院感染预防,以及对COVID-19感染的公共卫生反应。有关可用测试的临床表现的信息持续增长，但目前支持这一最新分子诊断指南的文献的证据质量仍为中等至非常低.认识到这些限制，IDSA小组权衡了现有的诊断证据,并建议对所有疑似患有COVID-19的有症状个体进行核酸检测.此外,建议对已知或怀疑与COVID-19病例接触的无症状个体进行检测，因为检测结果会影响隔离/隔离/个人防护装备（PPE）的使用决定。支持快速检测和检测除鼻咽拭子外的上呼吸道标本的证据，提供后勤优势，足以保证支持这些方法的有条件建议。
