Development of a Recombinant Nucleocapsid Protein‐Based ELISA for Detection of IgM and IgG Antibodies to SARS‐CoV‐2

Covid-19 is a global concern for public health. Thus, early and accurate diagnosis is a critical step in management of this infectious disease. Currently, RT-PCR is routine diagnosis test for covid-19, but it has some limitations and false negative results. ELISA against SARS-CoV-2 antigens seems to be an appropriate approach for serodiagnosis of Covid-19. In the current study, an ELISA system, using a recombinant nucleocapsid (N) protein, was developed for detection of IgM and IgG antibodies to SARS-CoV-2. The related protein was expressed, purified, and used in an ELISA system. Sera samples (67) for Covid-19 patients, as well as sera samples from healthy volunteers (112), along with sera samples (30) from non-Covid-19 patients were examined by the ELISA system. The expression and purity of the recombinant N protein were approved by SDS-PAGE and western blotting. The sensitivity of ELISA system was 91.04%, and 92.53% for the detection of IgG and IgM antibodies, respectively. Moreover, the specificity of the developed ELISA system for IgG and IgM were 98.21% and 97.32%, respectively. Our developed ELISA system showed satisfactory sensitivity and specificity for detection of antiSARS-CoV-2 IgM and IgG antibodies and could be used as a complementary approach for proper diagnosis of Covid-19.

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