biostudies-literatureUnknown519Fernandez ZSerological tests developed for COVID-19 diagnostic are based on antibodies specific for SARS-CoV-2 antigens. Most of the antigens consist of a fragment or a whole amino acid sequence of the nucleocapsid or spike proteins. We evaluated a chimeric recombinant protein as an antigen in an ELISA test, using the most conserved and hydrophilic portions of the S1-subunit of the S and Nucleocapsid (N) proteins. These proteins, individually, indicated a suitable sensitivity of 93.6 and 100% and a specificity of 94.5 and 91.3%, respectively. However, our study with the chimera containing S1 and N proteins of SARS-CoV-2 suggested that the recombinant protein could better balance both the sensitivity (95.7%) and the specificity (95.5%) of the serological assay when comparing with the ELISA test using Journal of immunological methods113489https://www.ebi.ac.uk/biostudies/studies/S-EPMC10174469biostudies-literatureDevelopment and validity assessment of ELISA test with recombinant chimeric protein of SARS-CoV-2.PMC10174469Silva MRde Arruda Rodrigues RDos Santos LRDemarchi LHFSarti EFBZardin MUde Souza VFBertolli GFLichs GCuenca VTorres JMMarcon GEBFernandez ZFavacho AAraujo Dde Castro Ferreira EGoncalves CCMde Araujo FRGuilhermino JfalseDevelopment and validity assessment of ELISA test with recombinant chimeric protein of SARS-CoV-2.Serological tests developed for COVID-19 diagnostic are based on antibodies specific for SARS-CoV-2 antigens. Most of the antigens consist of a fragment or a whole amino acid sequence of the nucleocapsid or spike proteins. We evaluated a chimeric recombinant protein as an antigen in an ELISA test, using the most conserved and hydrophilic portions of the S1-subunit of the S and Nucleocapsid (N) proteins. These proteins, individually, indicated a suitable sensitivity of 93.6 and 100% and a specificity of 94.5 and 91.3%, respectively. However, our study with the chimera containing S1 and N proteins of SARS-CoV-2 suggested that the recombinant protein could better balance both the sensitivity (95.7%) and the specificity (95.5%) of the serological assay when comparing with the ELISA test using 2023-01-01T00:00:00Z2023 Aug2025-04-04T10:19:46.389Z2025-02-19T00:12:20.125ZS-EPMC101744693717901110.1016/j.jim.2023.113489