Etievant Sibyle, Bal Antonin, Escuret Vanessa, Brengel-Pesce Karen, Bouscambert Maude, Cheynet Valérie, Generenaz Laurence, Oriol Guy, Destras Gregory, Billaud Geneviève, Josset Laurence, Frobert Emilie, Morfin Florence, Gaymard Alexandre
Laboratoire de Virologie, Institut des Agents Infectieux (IAI), Hospices Civils de Lyon, Groupement Hospitalier Nord, 69004 Lyon, France.
Centre National de Référence des Virus Respiratoires, Hospices Civils de Lyon, Groupement Hospitalier Nord, 69004 Lyon, France.
J Clin Med. 2020 Jun 16;9(6):1871. doi: 10.3390/jcm9061871.
A reliable diagnostic assay is crucial to early detect new COVID-19 cases and limit severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission. Since the onset of the COVID-19 pandemic, the World Health Organization has published several diagnostic molecular approaches developed by referral laboratories, including Charité (Germany), HKU (Hong Kong), China CDC (China), US CDC (United States), and Institut Pasteur, Paris (France). We aimed to compare the sensitivity and specificity of these different RT-PCR assays using SARS-CoV-2 cell culture supernatants and clinical respiratory samples. Overall, the different RT-PCR assays performed well for SARS-CoV-2 detection and were all specific except the N Charité (Germany), and N2 US CDC (United States) assays. RdRp Institut Pasteur (IP2, IP4), N China CDC, and N1 US CDC were found to be the most sensitive assays. The data presented herein are of prime importance to facilitate the equipment choice of diagnostic laboratories, as well as for the development of marketed tests.
一种可靠的诊断检测方法对于早期发现新型冠状病毒肺炎（COVID-19）病例以及限制严重急性呼吸综合征冠状病毒2（SARS-CoV-2）传播至关重要。自COVID-19大流行开始以来，世界卫生组织已发布了几家参考实验室开发的多种诊断分子方法，包括德国的夏里特医院、中国香港大学、中国疾病预防控制中心、美国疾病预防控制中心以及法国巴黎的巴斯德研究所。我们旨在使用SARS-CoV-2细胞培养上清液和临床呼吸道样本比较这些不同逆转录聚合酶链反应（RT-PCR）检测方法的敏感性和特异性。总体而言，不同的RT-PCR检测方法在检测SARS-CoV-2方面表现良好，除了德国夏里特医院的N检测方法和美国疾病预防控制中心的N2检测方法外，其余均具有特异性。发现巴斯德研究所的RdRp（IP2、IP4）、中国疾病预防控制中心的N以及美国疾病预防控制中心的N1检测方法最为敏感。本文提供的数据对于促进诊断实验室的设备选择以及市售检测产品的开发至关重要。
