Chen Jonathan Hon-Kwan, Yip Cyril Chik-Yan, Chan Jasper Fuk-Woo, Poon Rosana Wing-Shan, To Kelvin Kai-Wang, Chan Kwok-Hung, Cheng Vincent Chi-Chung, Yuen Kwok-Yung
Department of Microbiology, Queen Mary Hospital, Hong Kong Special Administrative Region, China
Department of Microbiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, China.
J Clin Microbiol. 2020 Jul 23;58(8). doi: 10.1128/JCM.00936-20.
In December 2019, the coronavirus disease 2019 (COVID-19) pandemic caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) was first reported in the Hubei province of China and later spread all over the world. There was an urgent need of a high-throughput molecular test for screening the COVID-19 patients in the community. The Luminex NxTAG CoV extended panel is a high-throughput FDA emergency use-authorized molecular diagnostic assay for SARS-CoV-2 detection. This system targets three genes (ORF1ab, N, and E genes) of SARS-CoV-2, the ORF1ab region of SARS-CoV, and the ORF5 region of MERS-CoV. In this study, we evaluated the diagnostic performance of this system with nasopharyngeal swab specimens of 214 suspected COVID-19 patients in Hong Kong. The results were compared with our routine COVID-19 reverse transcription-PCR (RT-PCR) protocol with a LightMix SarbecoV E-gene kit and an in-house RdRp/Hel RT-PCR assay. The NxTAG CoV extended panel demonstrated 97.8% sensitivity and 100% specificity to SARS-CoV-2 in nasopharyngeal specimens. On low-viral load specimens, the sensitivity of the NxTAG panel could still maintain at 85.71%. Strong agreement was observed between the NxTAG panel and the routine COVID-19 RT-PCR protocol (kappa value = 0.98). Overall, the E gene target of the NxTAG panel demonstrated the highest sensitivity among the three SARS-CoV-2 targets, while the N gene targets demonstrated the least. In conclusion, the NxTAG CoV extended panel is simple to use, and it has high diagnostic sensitivity and specificity to SARS-CoV-2 in nasopharyngeal specimens. We recommend this diagnostic system for high-throughput COVID-19 screening in the community.
2019年12月，由严重急性呼吸综合征冠状病毒2（SARS-CoV-2）引起的2019冠状病毒病（COVID-19）大流行首次在中国湖北省报告，随后蔓延至全球。社区迫切需要一种高通量分子检测方法来筛查COVID-19患者。Luminex NxTAG CoV扩展检测板是一种经美国食品药品监督管理局（FDA）紧急使用授权的用于检测SARS-CoV-2的高通量分子诊断检测方法。该系统针对SARS-CoV-2的三个基因（ORF1ab、N和E基因）、SARS-CoV的ORF1ab区域以及MERS-CoV的ORF5区域。在本研究中，我们用香港214例疑似COVID-19患者的鼻咽拭子标本评估了该系统的诊断性能。将结果与我们使用LightMix SarbecoV E基因试剂盒和内部RdRp/Hel逆转录聚合酶链反应（RT-PCR）检测方法的常规COVID-19 RT-PCR方案进行比较。NxTAG CoV扩展检测板对鼻咽标本中SARS-CoV-2的敏感性为97.8%，特异性为100%。在低病毒载量标本中，NxTAG检测板的敏感性仍可保持在85.71%。NxTAG检测板与常规COVID-19 RT-PCR方案之间观察到高度一致性（kappa值=0.98）。总体而言，NxTAG检测板的E基因靶点在三个SARS-CoV-2靶点中敏感性最高，而N基因靶点敏感性最低。总之，NxTAG CoV扩展检测板使用简便，对鼻咽标本中的SARS-CoV-2具有较高的诊断敏感性和特异性。我们推荐该诊断系统用于社区COVID-19的高通量筛查。
