DEVELOPMENT AND VALIDATION OF AN ENZYME-LINKED IMMUNOASSAY KIT FOR DIAGNOSIS AND SURVEILLANCE OF COVID-19.

IF 1.6 Q4 INFECTIOUS DISEASES Journal of clinical virology plus Pub Date : 2022-08-17 DOI:10.1016/j.jcvp.2022.100103

Flávia F Bagno, Sarah A R Sérgio, Maria Marta Figueiredo, Lara C Godoi, Luis A F Andrade, Natália C Salazar, Camila P Soares, Andressa Aguiar, Flávia Jaqueline Almeida, Edimilson D da Silva, Antônio G P Ferreira, Edison Luiz Durigon, Ricardo T Gazzinelli, Santuza M R Teixeira, Ana Paula S M Fernandes, Flavio G da Fonseca

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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.

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开发和验证用于诊断和监测科维-19 的酶联免疫测定试剂盒。

目前急需找到检测 COVID-19 新病例的替代方法，并对该疾病的流行病学进行调查。在许多国家，进口商业试剂盒严重影响了其检测能力，并增加了公共卫生系统的成本。我们利用在大肠杆菌中表达的重组病毒核壳蛋白（rN），开发了一种检测 SARS-CoV-2 IgG 抗体的酶联免疫吸附试验（ELISA）。通过对 894 份临床样本的检测，我们发现与商业抗体检测相比，rN-ELISA 能够检测出 SARS-CoV-2 的 IgG 抗体，灵敏度（97.5%）和特异性（96.3%）都很高。经过三次外部验证研究，我们发现该检测方法的准确率高于 90%。rN-ELISA IgG试剂盒是大规模测定人血清中SARS-CoV-2抗体的一种方便、特异、可靠的方法。

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