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":"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。","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":"{\"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}","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}
DEVELOPMENT AND VALIDATION OF AN ENZYME-LINKED IMMUNOASSAY KIT FOR DIAGNOSIS AND SURVEILLANCE OF COVID-19.
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.
京公网安备 11010802042870号
京ICP备2023020795号-1
分享
求助内容：
应助结果提醒方式：
扫码关注我们
