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
{"title":"DEVELOPMENT AND VALIDATION OF AN ENZYME-LINKED IMMUNOASSAY KIT FOR DIAGNOSIS AND SURVEILLANCE OF COVID-19.","authors":"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","doi":"10.1016/j.jcvp.2022.100103","DOIUrl":null,"url":null,"abstract":"<p><p>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 <i>E. coli</i>. 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.</p>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":" ","pages":"100103"},"PeriodicalIF":1.6000,"publicationDate":"2022-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9384617/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of clinical virology plus","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1016/j.jcvp.2022.100103","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
引用次数: 0
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.