TY - JOUR
T1 - Development and evaluation of a set of spike and receptor binding domain-based enzyme-linked immunosorbent assays for sars-cov-2 serological testing
AU - Camacho-Sandoval, Rosa
AU - Nieto-Patlán, Alejandro
AU - Carballo-Uicab, Gregorio
AU - Montes-Luna, Alejandra
AU - Jiménez-Martínez, María C.
AU - Vallejo-Castillo, Luis
AU - González-González, Edith
AU - Arrieta-Oliva, Hugo Iván
AU - Gómez-Castellano, Keyla
AU - Guzmán-Bringas, Omar U.
AU - Cruz-Domínguez, María Pilar
AU - Medina, Gabriela
AU - Montiel-Cervantes, Laura A.
AU - Gordillo-Marín, Maricela
AU - Vázquez-Campuzano, Roberto
AU - Torres-Longoria, Belem
AU - López-Martínez, Irma
AU - Pérez-Tapia, Sonia M.
AU - Almagro, Juan Carlos
N1 - Publisher Copyright:
© 2021 by the authors. Licensee MDPI, Basel, Switzerland.
PY - 2021/8
Y1 - 2021/8
N2 - 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® .
AB - 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® .
KW - COVID-19
KW - IgG isotypes
KW - Seroconversion
KW - Serological diagnostics
KW - UDITEST-V2G®
UR - http://www.scopus.com/inward/record.url?scp=85114100878&partnerID=8YFLogxK
U2 - 10.3390/diagnostics11081506
DO - 10.3390/diagnostics11081506
M3 - Artículo
C2 - 34441440
AN - SCOPUS:85114100878
SN - 2075-4418
VL - 11
JO - Diagnostics
JF - Diagnostics
IS - 8
M1 - 1506
ER -