Development and Evaluation of a Set of Spike and Receptor Binding Domain-Based Enzyme-Linked Immunosorbent Assays for SARS-CoV-2 Serological Testing
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 hi...
| Main Authors: | , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2021-08-01
|
| Series: | Diagnostics |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2075-4418/11/8/1506 |
| _version_ | 1797524163047456768 |
|---|---|
| author | 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 |
| author_facet | 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 |
| author_sort | Rosa Camacho-Sandoval |
| collection | DOAJ |
| description | 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<sup>®</sup>. |
| first_indexed | 2024-03-10T08:52:31Z |
| format | Article |
| id | doaj.art-4a657da22e8345dfb8ddf5ffac0a94c4 |
| institution | Directory Open Access Journal |
| issn | 2075-4418 |
| language | English |
| last_indexed | 2024-03-10T08:52:31Z |
| publishDate | 2021-08-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Diagnostics |
| spelling | doaj.art-4a657da22e8345dfb8ddf5ffac0a94c42023-11-22T07:21:29ZengMDPI AGDiagnostics2075-44182021-08-01118150610.3390/diagnostics11081506Development and Evaluation of a Set of Spike and Receptor Binding Domain-Based Enzyme-Linked Immunosorbent Assays for SARS-CoV-2 Serological TestingRosa Camacho-Sandoval0Alejandro Nieto-Patlán1Gregorio Carballo-Uicab2Alejandra Montes-Luna3María C. Jiménez-Martínez4Luis Vallejo-Castillo5Edith González-González6Hugo Iván Arrieta-Oliva7Keyla Gómez-Castellano8Omar U. Guzmán-Bringas9María Pilar Cruz-Domínguez10Gabriela Medina11Laura A. Montiel-Cervantes12Maricela Gordillo-Marín13Roberto Vázquez-Campuzano14Belem Torres-Longoria15Irma López-Martínez16Sonia M. Pérez-Tapia17Juan Carlos Almagro18Unidad de Desarrollo e Investigación en Bioprocesos (UDIBI), Escuela Nacional de Ciencias Biológicas, Instituto Politécnico Nacional, Mexico City 11340, MexicoUnidad de Desarrollo e Investigación en Bioprocesos (UDIBI), Escuela Nacional de Ciencias Biológicas, Instituto Politécnico Nacional, Mexico City 11340, MexicoUnidad de Desarrollo e Investigación en Bioprocesos (UDIBI), Escuela Nacional de Ciencias Biológicas, Instituto Politécnico Nacional, Mexico City 11340, MexicoUnidad de Desarrollo e Investigación en Bioprocesos (UDIBI), Escuela Nacional de Ciencias Biológicas, Instituto Politécnico Nacional, Mexico City 11340, MexicoDepartamento de Bioquímica, Facultad de Medicina UNAM, Mexico City 06800, MexicoUnidad de Desarrollo e Investigación en Bioprocesos (UDIBI), Escuela Nacional de Ciencias Biológicas, Instituto Politécnico Nacional, Mexico City 11340, MexicoUnidad de Desarrollo e Investigación en Bioprocesos (UDIBI), Escuela Nacional de Ciencias Biológicas, Instituto Politécnico Nacional, Mexico City 11340, MexicoUnidad de Desarrollo e Investigación en Bioprocesos (UDIBI), Escuela Nacional de Ciencias Biológicas, Instituto Politécnico Nacional, Mexico City 11340, MexicoUnidad de Desarrollo e Investigación en Bioprocesos (UDIBI), Escuela Nacional de Ciencias Biológicas, Instituto Politécnico Nacional, Mexico City 11340, MexicoUnidad de Desarrollo e Investigación en Bioprocesos (UDIBI), Escuela Nacional de Ciencias Biológicas, Instituto Politécnico Nacional, Mexico City 11340, MexicoDivisión de Investigación, Hospital de Especialidades Centro Médico Nacional La Raza, IMSS, Mexico City 02990, MexicoUnidad de Investigación Traslacional en Enfermedades Hemato-Oncológicas, Hospital de Especialidades Centro Médico Nacional La Raza, IMSS, Mexico City 02990, MexicoUnidad de Investigación Traslacional en Enfermedades Hemato-Oncológicas, Hospital de Especialidades Centro Médico Nacional La Raza, IMSS, Mexico City 02990, MexicoInstituto de Diagnóstico y Referencia Epidemiológicos (InDRE) “Dr. Manuel Martínez Báez”, Mexico City 01480, MexicoInstituto de Diagnóstico y Referencia Epidemiológicos (InDRE) “Dr. Manuel Martínez Báez”, Mexico City 01480, MexicoInstituto de Diagnóstico y Referencia Epidemiológicos (InDRE) “Dr. Manuel Martínez Báez”, Mexico City 01480, MexicoInstituto de Diagnóstico y Referencia Epidemiológicos (InDRE) “Dr. Manuel Martínez Báez”, Mexico City 01480, MexicoUnidad de Desarrollo e Investigación en Bioprocesos (UDIBI), Escuela Nacional de Ciencias Biológicas, Instituto Politécnico Nacional, Mexico City 11340, MexicoUnidad de Desarrollo e Investigación en Bioprocesos (UDIBI), Escuela Nacional de Ciencias Biológicas, Instituto Politécnico Nacional, Mexico City 11340, MexicoThe 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<sup>®</sup>.https://www.mdpi.com/2075-4418/11/8/1506COVID-19IgG isotypesserological diagnosticsseroconversionUDITEST-V2G<sup>®</sup> |
| spellingShingle | 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 Development and Evaluation of a Set of Spike and Receptor Binding Domain-Based Enzyme-Linked Immunosorbent Assays for SARS-CoV-2 Serological Testing Diagnostics COVID-19 IgG isotypes serological diagnostics seroconversion UDITEST-V2G<sup>®</sup> |
| title | Development and Evaluation of a Set of Spike and Receptor Binding Domain-Based Enzyme-Linked Immunosorbent Assays for SARS-CoV-2 Serological Testing |
| title_full | Development and Evaluation of a Set of Spike and Receptor Binding Domain-Based Enzyme-Linked Immunosorbent Assays for SARS-CoV-2 Serological Testing |
| title_fullStr | Development and Evaluation of a Set of Spike and Receptor Binding Domain-Based Enzyme-Linked Immunosorbent Assays for SARS-CoV-2 Serological Testing |
| title_full_unstemmed | Development and Evaluation of a Set of Spike and Receptor Binding Domain-Based Enzyme-Linked Immunosorbent Assays for SARS-CoV-2 Serological Testing |
| title_short | Development and Evaluation of a Set of Spike and Receptor Binding Domain-Based Enzyme-Linked Immunosorbent Assays for SARS-CoV-2 Serological Testing |
| title_sort | development and evaluation of a set of spike and receptor binding domain based enzyme linked immunosorbent assays for sars cov 2 serological testing |
| topic | COVID-19 IgG isotypes serological diagnostics seroconversion UDITEST-V2G<sup>®</sup> |
| url | https://www.mdpi.com/2075-4418/11/8/1506 |
| work_keys_str_mv | AT rosacamachosandoval developmentandevaluationofasetofspikeandreceptorbindingdomainbasedenzymelinkedimmunosorbentassaysforsarscov2serologicaltesting AT alejandronietopatlan developmentandevaluationofasetofspikeandreceptorbindingdomainbasedenzymelinkedimmunosorbentassaysforsarscov2serologicaltesting AT gregoriocarballouicab developmentandevaluationofasetofspikeandreceptorbindingdomainbasedenzymelinkedimmunosorbentassaysforsarscov2serologicaltesting AT alejandramontesluna developmentandevaluationofasetofspikeandreceptorbindingdomainbasedenzymelinkedimmunosorbentassaysforsarscov2serologicaltesting AT mariacjimenezmartinez developmentandevaluationofasetofspikeandreceptorbindingdomainbasedenzymelinkedimmunosorbentassaysforsarscov2serologicaltesting AT luisvallejocastillo developmentandevaluationofasetofspikeandreceptorbindingdomainbasedenzymelinkedimmunosorbentassaysforsarscov2serologicaltesting AT edithgonzalezgonzalez developmentandevaluationofasetofspikeandreceptorbindingdomainbasedenzymelinkedimmunosorbentassaysforsarscov2serologicaltesting AT hugoivanarrietaoliva developmentandevaluationofasetofspikeandreceptorbindingdomainbasedenzymelinkedimmunosorbentassaysforsarscov2serologicaltesting AT keylagomezcastellano developmentandevaluationofasetofspikeandreceptorbindingdomainbasedenzymelinkedimmunosorbentassaysforsarscov2serologicaltesting AT omaruguzmanbringas developmentandevaluationofasetofspikeandreceptorbindingdomainbasedenzymelinkedimmunosorbentassaysforsarscov2serologicaltesting AT mariapilarcruzdominguez developmentandevaluationofasetofspikeandreceptorbindingdomainbasedenzymelinkedimmunosorbentassaysforsarscov2serologicaltesting AT gabrielamedina developmentandevaluationofasetofspikeandreceptorbindingdomainbasedenzymelinkedimmunosorbentassaysforsarscov2serologicaltesting AT lauraamontielcervantes developmentandevaluationofasetofspikeandreceptorbindingdomainbasedenzymelinkedimmunosorbentassaysforsarscov2serologicaltesting AT maricelagordillomarin developmentandevaluationofasetofspikeandreceptorbindingdomainbasedenzymelinkedimmunosorbentassaysforsarscov2serologicaltesting AT robertovazquezcampuzano developmentandevaluationofasetofspikeandreceptorbindingdomainbasedenzymelinkedimmunosorbentassaysforsarscov2serologicaltesting AT belemtorreslongoria developmentandevaluationofasetofspikeandreceptorbindingdomainbasedenzymelinkedimmunosorbentassaysforsarscov2serologicaltesting AT irmalopezmartinez developmentandevaluationofasetofspikeandreceptorbindingdomainbasedenzymelinkedimmunosorbentassaysforsarscov2serologicaltesting AT soniampereztapia developmentandevaluationofasetofspikeandreceptorbindingdomainbasedenzymelinkedimmunosorbentassaysforsarscov2serologicaltesting AT juancarlosalmagro developmentandevaluationofasetofspikeandreceptorbindingdomainbasedenzymelinkedimmunosorbentassaysforsarscov2serologicaltesting |