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首页> 外文期刊>Journal of Clinical Microbiology >Understanding, Verifying, and Implementing Emergency Use Authorization Molecular Diagnostics for the Detection of SARS-CoV-2 RNA
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Understanding, Verifying, and Implementing Emergency Use Authorization Molecular Diagnostics for the Detection of SARS-CoV-2 RNA

机译：理解，验证和实施紧急使用授权分子诊断检测SARS-COV-2 RNA

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The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has brought a new wave of challenges to health care, particularly in the area of rapid diagnostic test development and implementation. The diagnosis of acute coronavirus disease 2019 (COVID-19) is critically dependent on the detection of SARS-CoV-2 RNA from clinical specimens (e.g., nasopharyngeal swabs). While laboratory-developed testing for SARS-CoV-2 is an essential component of diagnostic testing for this virus, the majority of clinical microbiology laboratories are dependent on commercially available SARS-CoV-2 molecular assays. ABSTRACT The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has brought a new wave of challenges to health care, particularly in the area of rapid diagnostic test development and implementation. The diagnosis of acute coronavirus disease 2019 (COVID-19) is critically dependent on the detection of SARS-CoV-2 RNA from clinical specimens (e.g., nasopharyngeal swabs). While laboratory-developed testing for SARS-CoV-2 is an essential component of diagnostic testing for this virus, the majority of clinical microbiology laboratories are dependent on commercially available SARS-CoV-2 molecular assays. In contrast to assays approved or cleared by the U.S. Food and Drug Administration (FDA) for in vitro diagnostic use, assays for the detection of SARS-CoV-2 nucleic acids have emergency use authorization (EUA) from the FDA. Outside of highly specialized academic and commercial laboratory settings, clinical microbiology laboratories are likely unfamiliar with the EUA classification, and thus, assay verification can be daunting. Further compounding anxiety for laboratories are major issues with the supply chain that are dramatically affecting the availability of test reagents and requiring laboratories to implement multiple commercial EUA tests. Here, we describe guidance for the verification of assays with EUA for the detection of SARS-CoV-2 nucleic acid from clinical specimens.
机译：严重的急性呼吸综合征冠状病毒2（SARS-COV-2）大流行为医疗保健带来了新的挑战，特别是在快速诊断测试开发和实施领域。急性冠状病毒疾病2019（Covid-19）的诊断主要取决于来自临床标本（例如鼻咽拭子）的SARS-COV-2 RNA的检测。虽然对SARS-COV-2的实验室开发的测试是该病毒诊断测试的必要组分，但大多数临床微生物学实验室依赖于商业上可获得的SARS-COV-2分子测定。摘要严重的急性呼吸综合征冠状病毒2（SARS-COV-2）大流行为医疗保健带来了新的挑战，特别是在快速诊断测试开发和实施领域。急性冠状病毒疾病2019（Covid-19）的诊断主要取决于来自临床标本（例如鼻咽拭子）的SARS-COV-2 RNA的检测。虽然对SARS-COV-2的实验室开发的测试是该病毒诊断测试的必要组分，但大多数临床微生物学实验室依赖于商业上可获得的SARS-COV-2分子测定。与由美国食品和药物管理局（FDA）批准或清除的测定相反，用于检测SARS-COV-2核酸的测定具有来自FDA的紧急使用授权（EUA）。在高度专业化的学术和商业实验室设置之外，临床微生物学实验室可能不熟悉欧盟分类，因此，测定验证可能是令人生畏的。对实验室的进一步混合焦虑是供应链的主要问题，这些供应链显着影响试剂的可用性，并要求实验室实施多种商业EUA测试。在此，我们描述了从临床标本检测SARS-COV-2核酸的EUA测定的指导。

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