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Development and Evaluation of a Set of Spike and Receptor Binding Domain-Based Enzyme-Linked Immunosorbent Assays for SARS-CoV-2 Serological Testing

Authors :
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
Source :
Diagnostics, Vol 11, Iss 8, p 1506 (2021)
Publication Year :
2021
Publisher :
MDPI AG, 2021.

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®.

Details

Language :
English
ISSN :
20754418
Volume :
11
Issue :
8
Database :
Directory of Open Access Journals
Journal :
Diagnostics
Publication Type :
Academic Journal
Accession number :
edsdoj.4a657da22e8345dfb8ddf5ffac0a94c4
Document Type :
article
Full Text :
https://doi.org/10.3390/diagnostics11081506