Performance Assessment of SARS-CoV-2 PCR Assays Developed by WHO Referral Laboratories
Performance Assessment of SARS-CoV-2 PCR Assays Developed by WHO Referral Laboratories
复制标题
DOI：
10.3390/jcm9061871
复制
发表时间：
2020-06-01
影响因子：
3.9
通讯作者：
Gaymard, Alexandre
中科院分区：
文献类型：
--
作者：
Etievant, Sibyle;Bal, Antonin;Gaymard, Alexandre
可靠的诊断方法对于早期发现新的COVID-19病例和限制严重急性呼吸道综合征冠状病毒2（SARS-CoV-2）传播至关重要。自2019冠状病毒病大流行爆发以来，世界卫生组织公布了由转介实验室开发的几种诊断分子方法，包括Charite（德国）、香港大学（香港）、中国疾病预防控制中心（中国）、美国疾病预防控制中心（美国）和巴斯德研究所（巴黎）（法国）。我们的目的是比较这些不同的RT-PCR检测的灵敏度和特异性，使用SARS-CoV-2细胞培养上清液和临床呼吸道样本。总的来说，不同的RT-PCR检测方法对SARS-CoV-2检测效果良好，除N Charite（德国）和N2 US CDC（美国）检测方法外，所有检测方法都具有特异性。发现RdRp Institut Pasteur（IP 2、IP 4）、N China CDC和N1 US CDC是最敏感的检测试剂盒。本文提供的数据对于促进诊断实验室的设备选择以及市场测试的开发至关重要。
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 Charite (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 Charite (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.