一种用于新型冠状病毒肺炎诊断和监测的酶联免疫分析试剂盒的研发与验证
DEVELOPMENT AND VALIDATION OF AN ENZYME-LINKED IMMUNOASSAY KIT FOR DIAGNOSIS AND SURVEILLANCE OF COVID-19.
作者信息
Bagno Flávia F, Sérgio Sarah A R, Figueiredo Maria Marta, Godoi Lara C, Andrade Luis A F, Salazar Natália C, Soares Camila P, Aguiar Andressa, Almeida Flávia Jaqueline, da Silva Edimilson D, Ferreira Antônio G P, Durigon Edison Luiz, Gazzinelli Ricardo T, Teixeira Santuza M R, Fernandes Ana Paula S M, da Fonseca Flavio G
机构信息
Centro de Tecnologia de Vacinas (CT Vacinas), BH-Tec, UFMG. Belo Horizonte, MG, Brazil.
Fundação Oswaldo Cruz-Fiocruz, Instituto Oswaldo Cruz, Rio de Janeiro, RJ, Brazil.
出版信息
J Clin Virol Plus. 2022 Aug 17:100103. doi: 10.1016/j.jcvp.2022.100103.
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 . 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.
迫切需要找到替代方法来检测新型冠状病毒肺炎（COVID-19）新病例，并调查该疾病的流行病学情况。在许多国家，进口商业试剂盒对其检测能力产生重大影响，并增加了公共卫生系统的成本。我们开发了一种酶联免疫吸附测定（ELISA），使用在……中表达的重组病毒核衣壳（rN）蛋白来检测针对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的免疫球蛋白G（IgG）抗体。使用总共894份临床样本，我们发现与商业抗体检测相比，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。经过三项外部验证研究，我们发现检测准确率高于90%。rN-ELISA IgG试剂盒是一种方便、特异的方法，可用于大规模检测人血清中SARS-CoV-2抗体，具有很高的可靠性。
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