Validation of Serological Methods for COVID-19 and Retrospective Screening of Health Employees and Visitors to the São Paulo University Hospital, Brazil
Reliable serological tests for the detection of SARS-CoV-2 antibodies among infected or vaccinated individuals are important for epidemiological and clinical studies. Low-cost approaches easily adaptable to high throughput screenings, such as Enzyme-Linked Immunosorbent Assays (ELISA) or electrochem...
| Main Authors: | , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2022-06-01
|
| Series: | Frontiers in Cellular and Infection Microbiology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fcimb.2022.787411/full |
| _version_ | 1818243572239958016 |
|---|---|
| author | Robert Andreata-Santos Robert Andreata-Santos Rafael Rahal Guaragna Machado Rúbens Prince dos Santos Alves Natiely Silva Sales Camila Pereira Soares Karine Bitencourt Rodrigues Mariângela Oliveira Silva Marianna Teixeira de Pinho Favaro Mônica Josiane Rodrigues-Jesus Márcio Massao Yamamoto Juliana Bannwart de Andrade Juliana Bannwart de Andrade Ricardo Ambrósio Fock Ricardo Ambrósio Fock Paulo Francisco Ramos Margarido Cristiane Rodrigues Guzzo Carvalho Silvia Beatriz Boscardin Edison Luiz Durigon Luís C. S. Ferreira Luís C. S. Ferreira |
| author_facet | Robert Andreata-Santos Robert Andreata-Santos Rafael Rahal Guaragna Machado Rúbens Prince dos Santos Alves Natiely Silva Sales Camila Pereira Soares Karine Bitencourt Rodrigues Mariângela Oliveira Silva Marianna Teixeira de Pinho Favaro Mônica Josiane Rodrigues-Jesus Márcio Massao Yamamoto Juliana Bannwart de Andrade Juliana Bannwart de Andrade Ricardo Ambrósio Fock Ricardo Ambrósio Fock Paulo Francisco Ramos Margarido Cristiane Rodrigues Guzzo Carvalho Silvia Beatriz Boscardin Edison Luiz Durigon Luís C. S. Ferreira Luís C. S. Ferreira |
| author_sort | Robert Andreata-Santos |
| collection | DOAJ |
| description | Reliable serological tests for the detection of SARS-CoV-2 antibodies among infected or vaccinated individuals are important for epidemiological and clinical studies. Low-cost approaches easily adaptable to high throughput screenings, such as Enzyme-Linked Immunosorbent Assays (ELISA) or electrochemiluminescence immunoassay (ECLIA), can be readily validated using different SARS-CoV-2 antigens. A total of 1,119 serum samples collected between March and July of 2020 from health employees and visitors to the University Hospital at the University of São Paulo were screened with the Elecsys® Anti-SARS-CoV-2 immunoassay (Elecsys) (Roche Diagnostics) and three in-house ELISAs that are based on different antigens: the Nucleoprotein (N-ELISA), the Receptor Binding Domain (RBD-ELISA), and a portion of the S1 protein (ΔS1-ELISA). Virus neutralization test (CPE-VNT) was used as the gold standard to validate the serological assays. We observed high sensitivity and specificity values with the Elecsys (96.92% and 98.78%, respectively) and N-ELISA (93.94% and 94.40%, respectively), compared with RBD-ELISA (90.91% sensitivity and 88.80% specificity) and the ΔS1-ELISA (77.27% sensitivity and 76% specificity). The Elecsys® proved to be a reliable SARS-CoV-2 serological test. Similarly, the recombinant SARS-CoV-2 N protein displayed good performance in the ELISA tests. The availability of reliable diagnostic tests is critical for the precise determination of infection rates, particularly in countries with high SARS-CoV-2 infection rates, such as Brazil. Collectively, our results indicate that the development and validation of new serological tests based on recombinant proteins may provide new alternatives for the SARS-CoV-2 diagnostic market. |
| first_indexed | 2024-12-12T14:03:15Z |
| format | Article |
| id | doaj.art-8edff3b146fb4b189c8edf0c5531c5bb |
| institution | Directory Open Access Journal |
| issn | 2235-2988 |
| language | English |
| last_indexed | 2024-12-12T14:03:15Z |
| publishDate | 2022-06-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Cellular and Infection Microbiology |
| spelling | doaj.art-8edff3b146fb4b189c8edf0c5531c5bb2022-12-22T00:22:17ZengFrontiers Media S.A.Frontiers in Cellular and Infection Microbiology2235-29882022-06-011210.3389/fcimb.2022.787411787411Validation of Serological Methods for COVID-19 and Retrospective Screening of Health Employees and Visitors to the São Paulo University Hospital, BrazilRobert Andreata-Santos0Robert Andreata-Santos1Rafael Rahal Guaragna Machado2Rúbens Prince dos Santos Alves3Natiely Silva Sales4Camila Pereira Soares5Karine Bitencourt Rodrigues6Mariângela Oliveira Silva7Marianna Teixeira de Pinho Favaro8Mônica Josiane Rodrigues-Jesus9Márcio Massao Yamamoto10Juliana Bannwart de Andrade11Juliana Bannwart de Andrade12Ricardo Ambrósio Fock13Ricardo Ambrósio Fock14Paulo Francisco Ramos Margarido15Cristiane Rodrigues Guzzo Carvalho16Silvia Beatriz Boscardin17Edison Luiz Durigon18Luís C. S. Ferreira19Luís C. S. Ferreira20Vaccine Development Laboratory, Biomedical Sciences Institute, University of São Paulo, São Paulo, BrazilRetrovirology Laboratory, Immunology and Microbiology Department, Federal University of São Paulo, São Paulo, BrazilClinical and Molecular Virology Laboratory, Microbiology Department, Institute of Biomedical Sciences, University of São Paulo, São Paulo, BrazilVaccine Development Laboratory, Biomedical Sciences Institute, University of São Paulo, São Paulo, BrazilVaccine Development Laboratory, Biomedical Sciences Institute, University of São Paulo, São Paulo, BrazilClinical and Molecular Virology Laboratory, Microbiology Department, Institute of Biomedical Sciences, University of São Paulo, São Paulo, BrazilVaccine Development Laboratory, Biomedical Sciences Institute, University of São Paulo, São Paulo, BrazilVaccine Development Laboratory, Biomedical Sciences Institute, University of São Paulo, São Paulo, BrazilVaccine Development Laboratory, Biomedical Sciences Institute, University of São Paulo, São Paulo, BrazilVaccine Development Laboratory, Biomedical Sciences Institute, University of São Paulo, São Paulo, BrazilDepartment of Parasitology, Institute of Biomedical Sciences, University of São Paulo, São Paulo, BrazilSchool of Pharmaceutical Sciences, University of São Paulo, São Paulo, BrazilClinical Laboratory Division, Pharmacy and Clinical Laboratory Department, University Hospital, University of São Paulo, São Paulo, BrazilSchool of Pharmaceutical Sciences, University of São Paulo, São Paulo, BrazilClinical Laboratory Division, Pharmacy and Clinical Laboratory Department, University Hospital, University of São Paulo, São Paulo, BrazilSchool of Pharmaceutical Sciences, University of São Paulo, São Paulo, BrazilMolecular and Structural Biology, Secretion Systems and c-di-GMP Signalling Laboratory, Department of Microbiology, Institute of Biomedical Sciences, University of São Paulo, São Paulo, BrazilDepartment of Parasitology, Institute of Biomedical Sciences, University of São Paulo, São Paulo, BrazilClinical and Molecular Virology Laboratory, Microbiology Department, Institute of Biomedical Sciences, University of São Paulo, São Paulo, BrazilVaccine Development Laboratory, Biomedical Sciences Institute, University of São Paulo, São Paulo, BrazilScientific Platform Pasteur/USP, University of São Paulo, São Paulo, BrazilReliable serological tests for the detection of SARS-CoV-2 antibodies among infected or vaccinated individuals are important for epidemiological and clinical studies. Low-cost approaches easily adaptable to high throughput screenings, such as Enzyme-Linked Immunosorbent Assays (ELISA) or electrochemiluminescence immunoassay (ECLIA), can be readily validated using different SARS-CoV-2 antigens. A total of 1,119 serum samples collected between March and July of 2020 from health employees and visitors to the University Hospital at the University of São Paulo were screened with the Elecsys® Anti-SARS-CoV-2 immunoassay (Elecsys) (Roche Diagnostics) and three in-house ELISAs that are based on different antigens: the Nucleoprotein (N-ELISA), the Receptor Binding Domain (RBD-ELISA), and a portion of the S1 protein (ΔS1-ELISA). Virus neutralization test (CPE-VNT) was used as the gold standard to validate the serological assays. We observed high sensitivity and specificity values with the Elecsys (96.92% and 98.78%, respectively) and N-ELISA (93.94% and 94.40%, respectively), compared with RBD-ELISA (90.91% sensitivity and 88.80% specificity) and the ΔS1-ELISA (77.27% sensitivity and 76% specificity). The Elecsys® proved to be a reliable SARS-CoV-2 serological test. Similarly, the recombinant SARS-CoV-2 N protein displayed good performance in the ELISA tests. The availability of reliable diagnostic tests is critical for the precise determination of infection rates, particularly in countries with high SARS-CoV-2 infection rates, such as Brazil. Collectively, our results indicate that the development and validation of new serological tests based on recombinant proteins may provide new alternatives for the SARS-CoV-2 diagnostic market.https://www.frontiersin.org/articles/10.3389/fcimb.2022.787411/fullSARS-CoV-2serologyELISAhealth employeesECLIAsurveillance |
| spellingShingle | Robert Andreata-Santos Robert Andreata-Santos Rafael Rahal Guaragna Machado Rúbens Prince dos Santos Alves Natiely Silva Sales Camila Pereira Soares Karine Bitencourt Rodrigues Mariângela Oliveira Silva Marianna Teixeira de Pinho Favaro Mônica Josiane Rodrigues-Jesus Márcio Massao Yamamoto Juliana Bannwart de Andrade Juliana Bannwart de Andrade Ricardo Ambrósio Fock Ricardo Ambrósio Fock Paulo Francisco Ramos Margarido Cristiane Rodrigues Guzzo Carvalho Silvia Beatriz Boscardin Edison Luiz Durigon Luís C. S. Ferreira Luís C. S. Ferreira Validation of Serological Methods for COVID-19 and Retrospective Screening of Health Employees and Visitors to the São Paulo University Hospital, Brazil Frontiers in Cellular and Infection Microbiology SARS-CoV-2 serology ELISA health employees ECLIA surveillance |
| title | Validation of Serological Methods for COVID-19 and Retrospective Screening of Health Employees and Visitors to the São Paulo University Hospital, Brazil |
| title_full | Validation of Serological Methods for COVID-19 and Retrospective Screening of Health Employees and Visitors to the São Paulo University Hospital, Brazil |
| title_fullStr | Validation of Serological Methods for COVID-19 and Retrospective Screening of Health Employees and Visitors to the São Paulo University Hospital, Brazil |
| title_full_unstemmed | Validation of Serological Methods for COVID-19 and Retrospective Screening of Health Employees and Visitors to the São Paulo University Hospital, Brazil |
| title_short | Validation of Serological Methods for COVID-19 and Retrospective Screening of Health Employees and Visitors to the São Paulo University Hospital, Brazil |
| title_sort | validation of serological methods for covid 19 and retrospective screening of health employees and visitors to the sao paulo university hospital brazil |
| topic | SARS-CoV-2 serology ELISA health employees ECLIA surveillance |
| url | https://www.frontiersin.org/articles/10.3389/fcimb.2022.787411/full |
| work_keys_str_mv | AT robertandreatasantos validationofserologicalmethodsforcovid19andretrospectivescreeningofhealthemployeesandvisitorstothesaopaulouniversityhospitalbrazil AT robertandreatasantos validationofserologicalmethodsforcovid19andretrospectivescreeningofhealthemployeesandvisitorstothesaopaulouniversityhospitalbrazil AT rafaelrahalguaragnamachado validationofserologicalmethodsforcovid19andretrospectivescreeningofhealthemployeesandvisitorstothesaopaulouniversityhospitalbrazil AT rubensprincedossantosalves validationofserologicalmethodsforcovid19andretrospectivescreeningofhealthemployeesandvisitorstothesaopaulouniversityhospitalbrazil AT natielysilvasales validationofserologicalmethodsforcovid19andretrospectivescreeningofhealthemployeesandvisitorstothesaopaulouniversityhospitalbrazil AT camilapereirasoares validationofserologicalmethodsforcovid19andretrospectivescreeningofhealthemployeesandvisitorstothesaopaulouniversityhospitalbrazil AT karinebitencourtrodrigues validationofserologicalmethodsforcovid19andretrospectivescreeningofhealthemployeesandvisitorstothesaopaulouniversityhospitalbrazil AT mariangelaoliveirasilva validationofserologicalmethodsforcovid19andretrospectivescreeningofhealthemployeesandvisitorstothesaopaulouniversityhospitalbrazil AT mariannateixeiradepinhofavaro validationofserologicalmethodsforcovid19andretrospectivescreeningofhealthemployeesandvisitorstothesaopaulouniversityhospitalbrazil AT monicajosianerodriguesjesus validationofserologicalmethodsforcovid19andretrospectivescreeningofhealthemployeesandvisitorstothesaopaulouniversityhospitalbrazil AT marciomassaoyamamoto validationofserologicalmethodsforcovid19andretrospectivescreeningofhealthemployeesandvisitorstothesaopaulouniversityhospitalbrazil AT julianabannwartdeandrade validationofserologicalmethodsforcovid19andretrospectivescreeningofhealthemployeesandvisitorstothesaopaulouniversityhospitalbrazil AT julianabannwartdeandrade validationofserologicalmethodsforcovid19andretrospectivescreeningofhealthemployeesandvisitorstothesaopaulouniversityhospitalbrazil AT ricardoambrosiofock validationofserologicalmethodsforcovid19andretrospectivescreeningofhealthemployeesandvisitorstothesaopaulouniversityhospitalbrazil AT ricardoambrosiofock validationofserologicalmethodsforcovid19andretrospectivescreeningofhealthemployeesandvisitorstothesaopaulouniversityhospitalbrazil AT paulofranciscoramosmargarido validationofserologicalmethodsforcovid19andretrospectivescreeningofhealthemployeesandvisitorstothesaopaulouniversityhospitalbrazil AT cristianerodriguesguzzocarvalho validationofserologicalmethodsforcovid19andretrospectivescreeningofhealthemployeesandvisitorstothesaopaulouniversityhospitalbrazil AT silviabeatrizboscardin validationofserologicalmethodsforcovid19andretrospectivescreeningofhealthemployeesandvisitorstothesaopaulouniversityhospitalbrazil AT edisonluizdurigon validationofserologicalmethodsforcovid19andretrospectivescreeningofhealthemployeesandvisitorstothesaopaulouniversityhospitalbrazil AT luiscsferreira validationofserologicalmethodsforcovid19andretrospectivescreeningofhealthemployeesandvisitorstothesaopaulouniversityhospitalbrazil AT luiscsferreira validationofserologicalmethodsforcovid19andretrospectivescreeningofhealthemployeesandvisitorstothesaopaulouniversityhospitalbrazil |