PDF(Pubmed)
Abstract：
There is a massive demand to identify alternative methods to detect new cases of COVID-19 as well as to investigate the epidemiology of the disease. In many countries, importation of commercial kits poses a significant impact on their testing capacity and increases the costs for the public health system. We have developed an ELISA to detect IgG antibodies against SARS-CoV-2 using a recombinant viral nucleocapsid (rN) protein expressed in E. coli. Using a total of 894 clinical samples we showed that the rN-ELISA was able to detect IgG antibodies against SARS-CoV-2 with high sensitivity (97.5%) and specificity (96.3%) when compared to a commercial antibody test. After three external validation studies, we showed that the test accuracy was higher than 90%. The rN-ELISA IgG kit constitutes a convenient and specific method for the large-scale determination of SARS-CoV-2 antibodies in human sera with high reliability.
摘要：
大量需要确定检测新病例的替代方法，以及调查该疾病的流行病学。在许多国家,进口商业试剂盒对其检测能力产生重大影响，并增加公共卫生系统的成本。我们已经开发了一种ELISA，使用在大肠杆菌中表达的重组病毒核衣壳（rN）蛋白来检测针对SARS-CoV-2的IgG抗体。使用总共894个临床样品，我们表明，与商业抗体测试相比，rN-ELISA能够以高灵敏度（97.5％）和特异性（96.3％）检测针对SARS-CoV-2的IgG抗体。经过三次外部验证研究,我们表明，测试的准确性高于90％。rN-ELISAIgG试剂盒为大规模测定人血清中SARS-CoV-2抗体提供了一种简便，特异的方法，可靠性高。
