Validation of N Protein Antibodies to Diagnose Previous SARS-CoV-2 Infection in a Large Cohort of Healthcare Workers: Use of Roche Elecsys<sup>®</sup> Immunoassay in the S Protein Vaccination Era
The aim of this study was to validate the detection of anti-nucleocapsid protein (N protein) antibodies for the diagnosis of SARS-CoV-2 infection in light of the fact that most COVID-19 vaccines use the spike (S) protein as the antigen. Here, 3550 healthcare workers (HCWs) were enrolled from May 202...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-04-01
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| Series: | Viruses |
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| Online Access: | https://www.mdpi.com/1999-4915/15/4/930 |
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| author | Juan Francisco Delgado Mònica Vidal Germà Julià Gema Navarro Rosa María Serrano Eva van den Eynde Marta Navarro Joan Calvet Jordi Gratacós Mateu Espasa Pilar Peña |
| author_facet | Juan Francisco Delgado Mònica Vidal Germà Julià Gema Navarro Rosa María Serrano Eva van den Eynde Marta Navarro Joan Calvet Jordi Gratacós Mateu Espasa Pilar Peña |
| author_sort | Juan Francisco Delgado |
| collection | DOAJ |
| description | The aim of this study was to validate the detection of anti-nucleocapsid protein (N protein) antibodies for the diagnosis of SARS-CoV-2 infection in light of the fact that most COVID-19 vaccines use the spike (S) protein as the antigen. Here, 3550 healthcare workers (HCWs) were enrolled from May 2020 (when no S protein vaccines were available). We defined SARS-CoV-2 infection if HCWs were found to be positive by RT-PCR or found to be positive in at least two different serological immunoassays. Serum samples from Biobanc I3PT-CERCA were analyzed by Roche Elecsys<sup>®</sup> (N protein) and Vircell IgG (N and S proteins) immunoassays. Discordant samples were reanalyzed with other commercial immunoassays. Roche Elecsys<sup>®</sup> showed the positivity of 539 (15.2%) HCWs, 664 (18.7%) were found to be positive by Vircell IgG immunoassays, and 164 samples (4.6%) showed discrepant results. According to our SARS-CoV-2 infection criteria, 563 HCWs had SARS-CoV-2 infection. The Roche Elecsys<sup>®</sup> immunoassay has a sensitivity, specificity, accuracy, and concordance with the presence of infection of 94.7%, 99.8%, 99.3%, and 0.96, respectively. Similar results were observed in a validation cohort of vaccinated HCWs. We conclude that the Roche Elecsys<sup>®</sup> SARS-CoV-2 N protein immunoassay demonstrated good performance in diagnosing previous SARS-CoV-2 infection in a large cohort of HCWs. |
| first_indexed | 2024-03-11T04:25:50Z |
| format | Article |
| id | doaj.art-1a3727d2bbf44749bf5cec785508347b |
| institution | Directory Open Access Journal |
| issn | 1999-4915 |
| language | English |
| last_indexed | 2024-03-11T04:25:50Z |
| publishDate | 2023-04-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Viruses |
| spelling | doaj.art-1a3727d2bbf44749bf5cec785508347b2023-11-17T21:45:48ZengMDPI AGViruses1999-49152023-04-0115493010.3390/v15040930Validation of N Protein Antibodies to Diagnose Previous SARS-CoV-2 Infection in a Large Cohort of Healthcare Workers: Use of Roche Elecsys<sup>®</sup> Immunoassay in the S Protein Vaccination EraJuan Francisco Delgado0Mònica Vidal1Germà Julià2Gema Navarro3Rosa María Serrano4Eva van den Eynde5Marta Navarro6Joan Calvet7Jordi Gratacós8Mateu Espasa9Pilar Peña10Immunology Laboratory, Clinic Laboratories Service, Parc Taulí Hospital Universitari, Institut d’Investigació i Innovació Parc Taulí (I3PT-CERCA), Departament de Medicina, Universitat Autònoma de Barcelona, 8207 Sabadell, SpainImmunology Laboratory, Clinic Laboratories Service, Parc Taulí Hospital Universitari, Institut d’Investigació i Innovació Parc Taulí (I3PT-CERCA), Departament de Medicina, Universitat Autònoma de Barcelona, 8207 Sabadell, SpainImmunology Laboratory, Clinic Laboratories Service, Parc Taulí Hospital Universitari, Institut d’Investigació i Innovació Parc Taulí (I3PT-CERCA), Departament de Medicina, Universitat Autònoma de Barcelona, 8207 Sabadell, SpainEpidemiology Service, Parc Taulí Hospital Universitari, Institut d’Investigació i Innovació Parc Taulí (I3PT-CERCA), Universitat Autònoma de Barcelona, 8207 Sabadell, SpainOccupational Health Department, Parc Taulí Hospital Universitari, Institut d’Investigació i Innovació Parc Taulí (I3PT-CERCA), Universitat Autònoma de Barcelona, 8207 Sabadell, SpainInfection Disease Department, Parc Taulí Hospital Universitari, Institut d’Investigació i Innovació Parc Taulí (I3PT-CERCA), Universitat Autònoma de Barcelona, 8207 Sabadell, SpainInfection Disease Department, Parc Taulí Hospital Universitari, Institut d’Investigació i Innovació Parc Taulí (I3PT-CERCA), Universitat Autònoma de Barcelona, 8207 Sabadell, SpainRheumatology Service, Parc Taulí Hospital Universitari, Institut d’Investigació i Innovació Parc Taulí (I3PT-CERCA), Departament de Medicina, Universitat Autònoma de Barcelona, 8207 Sabadell, SpainRheumatology Service, Parc Taulí Hospital Universitari, Institut d’Investigació i Innovació Parc Taulí (I3PT-CERCA), Departament de Medicina, Universitat Autònoma de Barcelona, 8207 Sabadell, SpainMicrobiology Section, Laboratory Service, Parc Taulí Hospital Universitari, Institut d’Investigació i Innovació Parc Taulí (I3PT-CERCA), Universitat Autònoma de Barcelona, 8207 Sabadell, SpainOccupational Health Department, Parc Taulí Hospital Universitari, Institut d’Investigació i Innovació Parc Taulí (I3PT-CERCA), Universitat Autònoma de Barcelona, 8207 Sabadell, SpainThe aim of this study was to validate the detection of anti-nucleocapsid protein (N protein) antibodies for the diagnosis of SARS-CoV-2 infection in light of the fact that most COVID-19 vaccines use the spike (S) protein as the antigen. Here, 3550 healthcare workers (HCWs) were enrolled from May 2020 (when no S protein vaccines were available). We defined SARS-CoV-2 infection if HCWs were found to be positive by RT-PCR or found to be positive in at least two different serological immunoassays. Serum samples from Biobanc I3PT-CERCA were analyzed by Roche Elecsys<sup>®</sup> (N protein) and Vircell IgG (N and S proteins) immunoassays. Discordant samples were reanalyzed with other commercial immunoassays. Roche Elecsys<sup>®</sup> showed the positivity of 539 (15.2%) HCWs, 664 (18.7%) were found to be positive by Vircell IgG immunoassays, and 164 samples (4.6%) showed discrepant results. According to our SARS-CoV-2 infection criteria, 563 HCWs had SARS-CoV-2 infection. The Roche Elecsys<sup>®</sup> immunoassay has a sensitivity, specificity, accuracy, and concordance with the presence of infection of 94.7%, 99.8%, 99.3%, and 0.96, respectively. Similar results were observed in a validation cohort of vaccinated HCWs. We conclude that the Roche Elecsys<sup>®</sup> SARS-CoV-2 N protein immunoassay demonstrated good performance in diagnosing previous SARS-CoV-2 infection in a large cohort of HCWs.https://www.mdpi.com/1999-4915/15/4/930SARS-CoV-2antibody responseinfectionvaccinationnucleocapsid proteinspike protein |
| spellingShingle | Juan Francisco Delgado Mònica Vidal Germà Julià Gema Navarro Rosa María Serrano Eva van den Eynde Marta Navarro Joan Calvet Jordi Gratacós Mateu Espasa Pilar Peña Validation of N Protein Antibodies to Diagnose Previous SARS-CoV-2 Infection in a Large Cohort of Healthcare Workers: Use of Roche Elecsys<sup>®</sup> Immunoassay in the S Protein Vaccination Era Viruses SARS-CoV-2 antibody response infection vaccination nucleocapsid protein spike protein |
| title | Validation of N Protein Antibodies to Diagnose Previous SARS-CoV-2 Infection in a Large Cohort of Healthcare Workers: Use of Roche Elecsys<sup>®</sup> Immunoassay in the S Protein Vaccination Era |
| title_full | Validation of N Protein Antibodies to Diagnose Previous SARS-CoV-2 Infection in a Large Cohort of Healthcare Workers: Use of Roche Elecsys<sup>®</sup> Immunoassay in the S Protein Vaccination Era |
| title_fullStr | Validation of N Protein Antibodies to Diagnose Previous SARS-CoV-2 Infection in a Large Cohort of Healthcare Workers: Use of Roche Elecsys<sup>®</sup> Immunoassay in the S Protein Vaccination Era |
| title_full_unstemmed | Validation of N Protein Antibodies to Diagnose Previous SARS-CoV-2 Infection in a Large Cohort of Healthcare Workers: Use of Roche Elecsys<sup>®</sup> Immunoassay in the S Protein Vaccination Era |
| title_short | Validation of N Protein Antibodies to Diagnose Previous SARS-CoV-2 Infection in a Large Cohort of Healthcare Workers: Use of Roche Elecsys<sup>®</sup> Immunoassay in the S Protein Vaccination Era |
| title_sort | validation of n protein antibodies to diagnose previous sars cov 2 infection in a large cohort of healthcare workers use of roche elecsys sup r sup immunoassay in the s protein vaccination era |
| topic | SARS-CoV-2 antibody response infection vaccination nucleocapsid protein spike protein |
| url | https://www.mdpi.com/1999-4915/15/4/930 |
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