Comparison of Four Molecular In Vitro Diagnostic Assays for the Detection of SARS-CoV-2 in Nasopharyngeal Specimens
Comparison of Four Molecular In Vitro Diagnostic Assays for the Detection of SARS-CoV-2 in Nasopharyngeal Specimens
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DOI：
10.1128/jcm.00743-20
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发表时间：
2020-08-01
影响因子：
9.4
通讯作者：
Berry, Gregory J.
中科院分区：
文献类型：
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作者：
Zhen, Wei;Manji, Ryhana;Berry, Gregory J.
严重急性呼吸综合征冠状病毒2型（SARS-CoV-2）是导致2019冠状病毒病（COVID-19）的新型人类冠状病毒，于2019年12月首次被发现，是中国湖北省武汉市爆发肺炎的原因。COVID-19的临床表现相当非特异性，症状与人群中同时流行的其他季节性呼吸道感染的症状重叠。此外，据估计，多达80%的感染者出现轻微症状或无症状，这使根据经验可靠诊断COVID-19的努力受到影响。为支持感染控制措施，迫切需要快速准确的分子诊断，以识别covid -19阳性患者。在本研究中，我们利用有症状患者的鼻咽拭子，评估了以下四种获得FDA紧急使用授权的SARS-CoV-2分子诊断试剂盒的分析敏感性和临床表现：纽约SARS-CoV-2实时逆转录酶(RT)-PCR诊断小组（改良的CDC）检测、Simplexa COVID-19 Direct （Diasorin Molecular）检测、GenMark ePlex SARS-CoV-2 （GenMark）检测和Hologic Panther Fusion SARS-CoV-2 （Hologic）检测。这些信息对于实验室和临床团队决定实施哪个检测平台至关重要。
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the novel human coronavirus that causes coronavirus disease 2019 (COVID-19), was first discovered in December 2019 as the cause of an outbreak of pneumonia in the city of Wuhan, Hubei province, China. The clinical presentation of COVID-19 is fairly non-specific, and symptoms overlap those of other seasonal respiratory infections concurrently circulating in the population. Furthermore, it is estimated that up to 80% of infected individuals experience mild symptoms or are asymptomatic, confounding efforts to reliably diagnose COVID-19 empirically. To support infection control measures, there is an urgent need for rapid and accurate molecular diagnostics to identify COVID-19-positive patients. In the present study, we evaluated the analytical sensitivity and clinical performance of the following four SARS-CoV-2 molecular diagnostic assays granted emergency use authorization by the FDA using nasopharyngeal swabs from symptomatic patients: the New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel (modified CDC) assay, the Simplexa COVID-19 Direct (Diasorin Molecular) assay, GenMark ePlex SARS-CoV-2 (GenMark) assay, and the Hologic Panther Fusion SARS-CoV-2 (Hologic) assay. This information is crucial for both laboratories and clinical teams as decisions on which testing platform to implement are made.