Development and validation of an enzyme-linked immunoassay kit for diagnosis and surveillance of COVID-19

被引：14

作者：

Bagno, Flavia F. ^{[1
,2
]}

Sergio, Sarah A. R. ^{[1
]}

Figueiredo, Maria Marta ^{[1
,8
]}

Godoi, Lara C. ^{[1
]}

Andrade, Luis A. F. ^{[1
]}

Salazar, Natalia C. ^{[1
]}

Soares, Camila P. ^{[3
]}

Aguiar, Andressa ^{[9
]}

Almeida, Flavia Jaqueline ^{[10
]}

da Silva, Edimilson D. ^{[2
]}

Ferreira, Antonio G. P. ^{[2
]}

Durigon, Edison Luiz ^{[3
]}

Gazzinelli, Ricardo T. ^{[1
,4
]}

Teixeira, Santuza M. R. ^{[1
,5
]}

Fernandes, Ana Paula S. M. ^{[1
,6
]}

da Fonseca, Flavio G. ^{[1
,7
]}

机构：

[1] Univ Fed Minas Gerais, BH Tec, Ctr Tecnol Vacinas CT Vacinas, Belo Horizonte, MG, Brazil

[2] Fundacao Oswaldo Cruz Fiocruz, Inst Oswaldo Cruz, Rio De Janeiro, RJ, Brazil

[3] Univ Sao Paulo, Inst Ciencias Biomed, Sao Paulo, SP, Brazil

[4] Fundacao Oswaldo Cruz Fiocruz, Ctr Pesquisas Rene Rachou, Belo Horizonte, MG, Brazil

[5] Univ Fed Minas Gerais, Dept Bioquim & Imunol, Belo Horizonte, MG, Brazil

[6] Univ Fed Minas Gerais, Fac Farm, Belo Horizonte, MG, Brazil

[7] Univ Fed Minas Gerais, Dept Microbiol, ICB UFMG, Belo Horizonte, MG, Brazil

[8] Univ Estadual Minas Gerais, Divinopolis, MG, Brazil

[9] Geriatr & Convalescent Hosp Dom Pedro II, Sao Paulo, SP, Brazil

[10] Santa Casa Sao Paulo Sch Med Sci, Dept Pediat, Sao Paulo, SP, Brazil

来源：

JOURNAL OF CLINICAL VIROLOGY PLUS | 2022年 / 2卷 / 03期

关键词：

SARS-CoV-2; COVID-19; Diagnosis; Serological assay; ELISA; Prototyping; INFECTION; ASSAY;

D O I：

10.1016/j.jcvp.2022.100101

中图分类号：

R51 [传染病];

学科分类号：

100401 ;

摘要：

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.

引用

页数：6

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