Development and evaluation of a set of spike and receptor binding domain-based enzyme-linked immunosorbent assays for sars-cov-2 serological testing

Rosa Camacho-Sandoval, Alejandro Nieto-Patlán, Gregorio Carballo-Uicab, Alejandra Montes-Luna, María C. Jiménez-Martínez, Luis Vallejo-Castillo, Edith González-González, Hugo Iván Arrieta-Oliva, Keyla Gómez-Castellano, Omar U. Guzmán-Bringas, María Pilar Cruz-Domínguez, Gabriela Medina, Laura A. Montiel-Cervantes, Maricela Gordillo-Marín, Roberto Vázquez-Campuzano, Belem Torres-Longoria, Irma López-Martínez, Sonia M. Pérez-Tapia, Juan Carlos Almagro

Research output: Contribution to journalArticlepeer-review

10 Scopus citations

Abstract

The implementation and validation of anti-SARS-CoV-2 IgG serological assays are reported in this paper. S1 and RBD proteins were used to coat ELISA plates, and several secondary antibodies served as reporters. The assays were initially validated with 50 RT-PCR positive COVID-19 sera, which showed high IgG titers of mainly IgG1 isotype, followed by IgG3. Low or no IgG2 and IgG4 titers were detected. Then, the RBD/IgG assay was further validated with 887 serum samples from RT-PCR positive COVID-19 individuals collected at different times, including 7, 14, 21, and 40 days after the onset of symptoms. Most of the sera were IgG positive at day 40, with seroconversion happening after 14–21 days. A third party conducted an additional performance test of the RBD/IgG assay with 406 sera, including 149 RT-PCR positive COVID-19 samples, 229 RT-PCR negative COVID-19 individuals, and 28 sera from individuals with other viral infections not related to SARS-CoV-2. The sensitivity of the assay was 99.33%, with a specificity of 97.82%. All the sera collected from individuals with infectious diseases other than COVID-19 were negative. Given the robustness of this RBD/IgG assay, it received approval from the sanitary authority in Mexico (COFEPRIS) for production and commercialization under the name UDISTEST-V2G® .

Original languageEnglish
Article number1506
JournalDiagnostics
Volume11
Issue number8
DOIs
StatePublished - Aug 2021

Keywords

  • COVID-19
  • IgG isotypes
  • Seroconversion
  • Serological diagnostics
  • UDITEST-V2G®

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