Real-world accuracy of SARS-CoV-2 antigen detection compared with qPCR: A cross-sectional study in Toledo - PR, Brazil
Rapid Antigen Tests (Ag-RDTs) for the detection of SARS-CoV-2 is an important diagnostic tool for containing virus spread. However, their accuracy ‒ the proportion of correct results (both true positives and true negatives) ‒ still needs to be proven when used in a real large-scale context. Accordin...
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Elsevier
2025-05-01
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| Series: | Brazilian Journal of Infectious Diseases |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S1413867025000236 |
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| author | Carla Adriane Royer Regis Goulart Rosa Maicon Falavigna Jaqueline Carvalho de Oliveira Mariana Motta Dias da Silva Carolina Gracia Poitevin Hellen Abreu Valter Antonio Baura Ana Claudia Bonatto Daniela Fiori Gradia Cristina de Oliveira Rodrigues Rafael Messias Luiz Ana Paula Carneiro Brandalize Josélia Larger Manfio Cintia Laura Pereira de Araujo Ana Paula de Souza Daniel Sganzerla Caroline Cabral Robinson Fernanda Kelly Romeiro Silva Gabriela Almeida Kucharski Fernando Pedrotti Srinivas Rao Valluri Amit Srivastava Viviane Wal Julião Olga Chameh Melone Florence Lefebvre d'Hellencourt Moe H Kyaw Julia Spinardi Graciela del Carmen Morales Castillo Emanuel Maltempi de Souza |
| author_facet | Carla Adriane Royer Regis Goulart Rosa Maicon Falavigna Jaqueline Carvalho de Oliveira Mariana Motta Dias da Silva Carolina Gracia Poitevin Hellen Abreu Valter Antonio Baura Ana Claudia Bonatto Daniela Fiori Gradia Cristina de Oliveira Rodrigues Rafael Messias Luiz Ana Paula Carneiro Brandalize Josélia Larger Manfio Cintia Laura Pereira de Araujo Ana Paula de Souza Daniel Sganzerla Caroline Cabral Robinson Fernanda Kelly Romeiro Silva Gabriela Almeida Kucharski Fernando Pedrotti Srinivas Rao Valluri Amit Srivastava Viviane Wal Julião Olga Chameh Melone Florence Lefebvre d'Hellencourt Moe H Kyaw Julia Spinardi Graciela del Carmen Morales Castillo Emanuel Maltempi de Souza |
| author_sort | Carla Adriane Royer |
| collection | DOAJ |
| description | Rapid Antigen Tests (Ag-RDTs) for the detection of SARS-CoV-2 is an important diagnostic tool for containing virus spread. However, their accuracy ‒ the proportion of correct results (both true positives and true negatives) ‒ still needs to be proven when used in a real large-scale context. Accordingly, we provide data from a cross-sectional study conducted in Toledo - PR, Brazil, on the accuracy of rapid tests compared with qPCR within the Brazilian Unified Health System. A total of 2882 thousand individuals presenting symptoms suggestive of COVID-19 were screened. Overall, the antigen tests showed a sensitivity, specificity, and accuracy of 59 % (0.56‒0.62), 99 % (0.98‒0.99), and 82 % (0.81‒0.84) respectively. However, a significant difference was found when analysing two brand tests individually. In addition, for patients with a low quantification Cycle (Cq) < 20 (which indicates a high viral load), the agreement between test results was high (90.85 %). However, this agreement decreased significantly when the viral load decreased, dropping to 5.59 % for samples with Cq ≥ 33, which indicates a lower viral load. While rapid antigen tests are a valuable tool in combating virus spread, their accuracy can vary significantly between manufacturers and under conditions of low viral load. |
| format | Article |
| id | doaj-art-ea16453fa1744b08b05c8a083a1ce3e2 |
| institution | OA Journals |
| issn | 1413-8670 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Brazilian Journal of Infectious Diseases |
| spelling | doaj-art-ea16453fa1744b08b05c8a083a1ce3e22025-08-20T02:31:56ZengElsevierBrazilian Journal of Infectious Diseases1413-86702025-05-0129310452010.1016/j.bjid.2025.104520Real-world accuracy of SARS-CoV-2 antigen detection compared with qPCR: A cross-sectional study in Toledo - PR, BrazilCarla Adriane Royer0Regis Goulart Rosa1Maicon Falavigna2Jaqueline Carvalho de Oliveira3Mariana Motta Dias da Silva4Carolina Gracia Poitevin5Hellen Abreu6Valter Antonio Baura7Ana Claudia Bonatto8Daniela Fiori Gradia9Cristina de Oliveira Rodrigues10Rafael Messias Luiz11Ana Paula Carneiro Brandalize12Josélia Larger Manfio13Cintia Laura Pereira de Araujo14Ana Paula de Souza15Daniel Sganzerla16Caroline Cabral Robinson17Fernanda Kelly Romeiro Silva18Gabriela Almeida Kucharski19Fernando Pedrotti20Srinivas Rao Valluri21Amit Srivastava22Viviane Wal Julião23Olga Chameh Melone24Florence Lefebvre d'Hellencourt25Moe H Kyaw26Julia Spinardi27Graciela del Carmen Morales Castillo28Emanuel Maltempi de Souza29Department of Genetics; Federal University of Parana (UFPR); Curitiba, (PR), BrazilResearch Unit, Inova Medical, Porto Alegre, RS, Brazil; Research Institute, Hospital Moinhos de Vento (HMV), Porto Alegre, RS, Brazil; Internal Medicine Department, HMV, Porto Alegre, RS, BrazilResearch Unit, Inova Medical, Porto Alegre, RS, Brazil; Research Institute, Hospital Moinhos de Vento (HMV), Porto Alegre, RS, Brazil; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, CanadaDepartment of Genetics; Federal University of Parana (UFPR); Curitiba, (PR), Brazil; Correspondence author at. Department of Genetics; Federal University of Parana; Curitiba, 81531-980, Brazil.Research Institute, Hospital Moinhos de Vento (HMV), Porto Alegre, RS, Brazil.Department of Genetics; Federal University of Parana (UFPR); Curitiba, (PR), Brazil.Department of Genetics; Federal University of Parana (UFPR); Curitiba, (PR), Brazil.Department of Biochemistry and Molecular Biology, UFPR, Curitiba, PR, BrazilDepartment of Genetics; Federal University of Parana (UFPR); Curitiba, (PR), Brazil.Department of Genetics; Federal University of Parana (UFPR); Curitiba, (PR), Brazil.Faculty of Medicine - Campus Toledo, UFPR, BrazilFaculty of Medicine - Campus Toledo, UFPR, BrazilFaculty of Medicine - Campus Toledo, UFPR, BrazilResearch Institute, Hospital Moinhos de Vento (HMV), Porto Alegre, RS, Brazil.Research Institute, Hospital Moinhos de Vento (HMV), Porto Alegre, RS, Brazil.Research Institute, Hospital Moinhos de Vento (HMV), Porto Alegre, RS, Brazil.Research Unit, Inova Medical, Porto Alegre, RS, Brazil.; Research Institute, Hospital Moinhos de Vento (HMV), Porto Alegre, RS, Brazil.Research Unit, Inova Medical, Porto Alegre, RS, Brazil.Research Institute, Hospital Moinhos de Vento (HMV), Porto Alegre, RS, Brazil.Department of Health of Toledo, Toledo, PR, BrazilDepartment of Health of Toledo, Toledo, PR, BrazilPfizer, Vaccines Medical and Scientific Affairs – Emerging Markets, Collegeville, PA, USAPfizer, Vaccines Medical and Scientific Affairs – Emerging Markets, Collegeville, PA, USA; Orbital Therapeutics, Cambridge, MA, USAPfizer, Vaccines Medical and Scientific Affairs – Emerging Markets, Collegeville, PA, USAPfizer, Vaccines Medical and Scientific Affairs – Emerging Markets, Collegeville, PA, USAPfizer, Vaccines Medical and Scientific Affairs – Emerging Markets, Collegeville, PA, USAPfizer, Vaccines Medical and Scientific Affairs – Emerging Markets, Collegeville, PA, USAPfizer, Vaccines Medical and Scientific Affairs – Emerging Markets, Collegeville, PA, USAPfizer, Vaccines Medical and Scientific Affairs – Emerging Markets, Collegeville, PA, USADepartment of Biochemistry and Molecular Biology, UFPR, Curitiba, PR, BrazilRapid Antigen Tests (Ag-RDTs) for the detection of SARS-CoV-2 is an important diagnostic tool for containing virus spread. However, their accuracy ‒ the proportion of correct results (both true positives and true negatives) ‒ still needs to be proven when used in a real large-scale context. Accordingly, we provide data from a cross-sectional study conducted in Toledo - PR, Brazil, on the accuracy of rapid tests compared with qPCR within the Brazilian Unified Health System. A total of 2882 thousand individuals presenting symptoms suggestive of COVID-19 were screened. Overall, the antigen tests showed a sensitivity, specificity, and accuracy of 59 % (0.56‒0.62), 99 % (0.98‒0.99), and 82 % (0.81‒0.84) respectively. However, a significant difference was found when analysing two brand tests individually. In addition, for patients with a low quantification Cycle (Cq) < 20 (which indicates a high viral load), the agreement between test results was high (90.85 %). However, this agreement decreased significantly when the viral load decreased, dropping to 5.59 % for samples with Cq ≥ 33, which indicates a lower viral load. While rapid antigen tests are a valuable tool in combating virus spread, their accuracy can vary significantly between manufacturers and under conditions of low viral load.http://www.sciencedirect.com/science/article/pii/S1413867025000236COVID-19PerformanceRapid antigen testsViral load |
| spellingShingle | Carla Adriane Royer Regis Goulart Rosa Maicon Falavigna Jaqueline Carvalho de Oliveira Mariana Motta Dias da Silva Carolina Gracia Poitevin Hellen Abreu Valter Antonio Baura Ana Claudia Bonatto Daniela Fiori Gradia Cristina de Oliveira Rodrigues Rafael Messias Luiz Ana Paula Carneiro Brandalize Josélia Larger Manfio Cintia Laura Pereira de Araujo Ana Paula de Souza Daniel Sganzerla Caroline Cabral Robinson Fernanda Kelly Romeiro Silva Gabriela Almeida Kucharski Fernando Pedrotti Srinivas Rao Valluri Amit Srivastava Viviane Wal Julião Olga Chameh Melone Florence Lefebvre d'Hellencourt Moe H Kyaw Julia Spinardi Graciela del Carmen Morales Castillo Emanuel Maltempi de Souza Real-world accuracy of SARS-CoV-2 antigen detection compared with qPCR: A cross-sectional study in Toledo - PR, Brazil Brazilian Journal of Infectious Diseases COVID-19 Performance Rapid antigen tests Viral load |
| title | Real-world accuracy of SARS-CoV-2 antigen detection compared with qPCR: A cross-sectional study in Toledo - PR, Brazil |
| title_full | Real-world accuracy of SARS-CoV-2 antigen detection compared with qPCR: A cross-sectional study in Toledo - PR, Brazil |
| title_fullStr | Real-world accuracy of SARS-CoV-2 antigen detection compared with qPCR: A cross-sectional study in Toledo - PR, Brazil |
| title_full_unstemmed | Real-world accuracy of SARS-CoV-2 antigen detection compared with qPCR: A cross-sectional study in Toledo - PR, Brazil |
| title_short | Real-world accuracy of SARS-CoV-2 antigen detection compared with qPCR: A cross-sectional study in Toledo - PR, Brazil |
| title_sort | real world accuracy of sars cov 2 antigen detection compared with qpcr a cross sectional study in toledo pr brazil |
| topic | COVID-19 Performance Rapid antigen tests Viral load |
| url | http://www.sciencedirect.com/science/article/pii/S1413867025000236 |
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