Performance of a Point of Care Test for Detecting IgM and IgG Antibodies Against SARS-CoV-2 and Seroprevalence in Blood Donors and Health Care Workers in Panama
Novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the etiologic agent of the ongoing coronavirus disease 2019 (COVID-19) pandemic, which has reached 28 million cases worldwide in 1 year. The serological detection of antibodies against the virus will play a pivotal role in complem...
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Format: | Article |
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Frontiers Media S.A.
2021-03-01
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Series: | Frontiers in Medicine |
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Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2021.616106/full |
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language |
English |
format |
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sources |
DOAJ |
author |
Alcibiades Villarreal Giselle Rangel Xu Zhang Xu Zhang Xu Zhang Digna Wong Gabrielle Britton Patricia L. Fernandez Ambar Pérez Diana Oviedo Diana Oviedo Carlos Restrepo María B. Carreirra Dilcia Sambrano Gilberto A. Eskildsen Gilberto A. Eskildsen Carolina De La Guardia Julio Flores-Cuadra Jean-Paul Carrera Yamitzel Zaldivar Danilo Franco Sandra López-Vergès Dexi Zhang Dexi Zhang Dexi Zhang Fangjing Fan Fangjing Fan Fangjing Fan Baojun Wang Xavier Sáez-Llorens Rodrigo DeAntonio Ivonne Torres-Atencio Isabel Blanco Fernando Diaz Subía Laiss Mudarra Aron Benzadon Walter Valverde Lineth López Nicolás Hurtado Neyla Rivas Julio Jurado Aixa Carvallo Juan Rodriguez Yaseikiry Perez Johanna Morris Odemaris Luque David Cortez Eduardo Ortega-Barria Rao Kosagisharaf Ricardo Lleonart Chong Li Chong Li Chong Li Amador Goodridge |
spellingShingle |
Alcibiades Villarreal Giselle Rangel Xu Zhang Xu Zhang Xu Zhang Digna Wong Gabrielle Britton Patricia L. Fernandez Ambar Pérez Diana Oviedo Diana Oviedo Carlos Restrepo María B. Carreirra Dilcia Sambrano Gilberto A. Eskildsen Gilberto A. Eskildsen Carolina De La Guardia Julio Flores-Cuadra Jean-Paul Carrera Yamitzel Zaldivar Danilo Franco Sandra López-Vergès Dexi Zhang Dexi Zhang Dexi Zhang Fangjing Fan Fangjing Fan Fangjing Fan Baojun Wang Xavier Sáez-Llorens Rodrigo DeAntonio Ivonne Torres-Atencio Isabel Blanco Fernando Diaz Subía Laiss Mudarra Aron Benzadon Walter Valverde Lineth López Nicolás Hurtado Neyla Rivas Julio Jurado Aixa Carvallo Juan Rodriguez Yaseikiry Perez Johanna Morris Odemaris Luque David Cortez Eduardo Ortega-Barria Rao Kosagisharaf Ricardo Lleonart Chong Li Chong Li Chong Li Amador Goodridge Performance of a Point of Care Test for Detecting IgM and IgG Antibodies Against SARS-CoV-2 and Seroprevalence in Blood Donors and Health Care Workers in Panama Frontiers in Medicine COVID-19 Panama serology biomarker immunochromatographic assay diagnosis |
author_facet |
Alcibiades Villarreal Giselle Rangel Xu Zhang Xu Zhang Xu Zhang Digna Wong Gabrielle Britton Patricia L. Fernandez Ambar Pérez Diana Oviedo Diana Oviedo Carlos Restrepo María B. Carreirra Dilcia Sambrano Gilberto A. Eskildsen Gilberto A. Eskildsen Carolina De La Guardia Julio Flores-Cuadra Jean-Paul Carrera Yamitzel Zaldivar Danilo Franco Sandra López-Vergès Dexi Zhang Dexi Zhang Dexi Zhang Fangjing Fan Fangjing Fan Fangjing Fan Baojun Wang Xavier Sáez-Llorens Rodrigo DeAntonio Ivonne Torres-Atencio Isabel Blanco Fernando Diaz Subía Laiss Mudarra Aron Benzadon Walter Valverde Lineth López Nicolás Hurtado Neyla Rivas Julio Jurado Aixa Carvallo Juan Rodriguez Yaseikiry Perez Johanna Morris Odemaris Luque David Cortez Eduardo Ortega-Barria Rao Kosagisharaf Ricardo Lleonart Chong Li Chong Li Chong Li Amador Goodridge |
author_sort |
Alcibiades Villarreal |
title |
Performance of a Point of Care Test for Detecting IgM and IgG Antibodies Against SARS-CoV-2 and Seroprevalence in Blood Donors and Health Care Workers in Panama |
title_short |
Performance of a Point of Care Test for Detecting IgM and IgG Antibodies Against SARS-CoV-2 and Seroprevalence in Blood Donors and Health Care Workers in Panama |
title_full |
Performance of a Point of Care Test for Detecting IgM and IgG Antibodies Against SARS-CoV-2 and Seroprevalence in Blood Donors and Health Care Workers in Panama |
title_fullStr |
Performance of a Point of Care Test for Detecting IgM and IgG Antibodies Against SARS-CoV-2 and Seroprevalence in Blood Donors and Health Care Workers in Panama |
title_full_unstemmed |
Performance of a Point of Care Test for Detecting IgM and IgG Antibodies Against SARS-CoV-2 and Seroprevalence in Blood Donors and Health Care Workers in Panama |
title_sort |
performance of a point of care test for detecting igm and igg antibodies against sars-cov-2 and seroprevalence in blood donors and health care workers in panama |
publisher |
Frontiers Media S.A. |
series |
Frontiers in Medicine |
issn |
2296-858X |
publishDate |
2021-03-01 |
description |
Novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the etiologic agent of the ongoing coronavirus disease 2019 (COVID-19) pandemic, which has reached 28 million cases worldwide in 1 year. The serological detection of antibodies against the virus will play a pivotal role in complementing molecular tests to improve diagnostic accuracy, contact tracing, vaccine efficacy testing, and seroprevalence surveillance. Here, we aimed first to evaluate a lateral flow assay's ability to identify specific IgM and IgG antibodies against SARS-CoV-2 and second, to report the seroprevalence estimates of these antibodies among health care workers and healthy volunteer blood donors in Panama. We recruited study participants between April 30th and July 7th, 2020. For the test validation and performance evaluation, we analyzed serum samples from participants with clinical symptoms and confirmed positive RT-PCR for SARS-CoV-2, and a set of pre-pandemic serum samples. We used two by two table analysis to determine the test positive and negative percentage agreement as well as the Kappa agreement value with a 95% confidence interval. Then, we used the lateral flow assay to determine seroprevalence among serum samples from COVID-19 patients, potentially exposed health care workers, and healthy volunteer donors. Our results show this assay reached a positive percent agreement of 97.2% (95% CI 84.2–100.0%) for detecting both IgM and IgG. The assay showed a Kappa of 0.898 (95%CI 0.811–0.985) and 0.918 (95% CI 0.839–0.997) for IgM and IgG, respectively. The evaluation of serum samples from hospitalized COVID-19 patients indicates a correlation between test sensitivity and the number of days since symptom onset; the highest positive percent agreement [87% (95% CI 67.0–96.3%)] was observed at ≥15 days post-symptom onset (PSO). We found an overall antibody seroprevalence of 11.6% (95% CI 8.5–15.8%) among both health care workers and healthy blood donors. Our findings suggest this lateral flow assay could contribute significantly to implementing seroprevalence testing in locations with active community transmission of SARS-CoV-2. |
topic |
COVID-19 Panama serology biomarker immunochromatographic assay diagnosis |
url |
https://www.frontiersin.org/articles/10.3389/fmed.2021.616106/full |
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doaj-aa97be51f8f54ba6a671e9e54778ce372021-03-03T16:16:44ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2021-03-01810.3389/fmed.2021.616106616106Performance of a Point of Care Test for Detecting IgM and IgG Antibodies Against SARS-CoV-2 and Seroprevalence in Blood Donors and Health Care Workers in PanamaAlcibiades Villarreal0Giselle Rangel1Xu Zhang2Xu Zhang3Xu Zhang4Digna Wong5Gabrielle Britton6Patricia L. Fernandez7Ambar Pérez8Diana Oviedo9Diana Oviedo10Carlos Restrepo11María B. Carreirra12Dilcia Sambrano13Gilberto A. Eskildsen14Gilberto A. Eskildsen15Carolina De La Guardia16Julio Flores-Cuadra17Jean-Paul Carrera18Yamitzel Zaldivar19Danilo Franco20Sandra López-Vergès21Dexi Zhang22Dexi Zhang23Dexi Zhang24Fangjing Fan25Fangjing Fan26Fangjing Fan27Baojun Wang28Xavier Sáez-Llorens29Rodrigo DeAntonio30Ivonne Torres-Atencio31Isabel Blanco32Fernando Diaz Subía33Laiss Mudarra34Aron Benzadon35Walter Valverde36Lineth López37Nicolás Hurtado38Neyla Rivas39Julio Jurado40Aixa Carvallo41Juan Rodriguez42Yaseikiry Perez43Johanna Morris44Odemaris Luque45David Cortez46Eduardo Ortega-Barria47Rao Kosagisharaf48Ricardo Lleonart49Chong Li50Chong Li51Chong Li52Amador Goodridge53Centro de Biología Celular y Molecular de las Enfermedades, City of Knowledge, Instituto de Investigaciones Científicas y Servicios de Alta Tecnología (INDICASAT-AIP), Panama City, PanamaCentro de Biología Celular y Molecular de las Enfermedades, City of Knowledge, Instituto de Investigaciones Científicas y Servicios de Alta Tecnología (INDICASAT-AIP), Panama City, PanamaInstitute of Biophysics, Chinese Academy of Sciences, Beijing, ChinaBeijing Zhongke Jianlan Biotechnology Co. Ltd., Beijing, ChinaZhongke Jianlan International Medical Research Institute, Melbourne, VIC, AustraliaCentro de Biología Celular y Molecular de las Enfermedades, City of Knowledge, Instituto de Investigaciones Científicas y Servicios de Alta Tecnología (INDICASAT-AIP), Panama City, PanamaCentro de Biología Celular y Molecular de las Enfermedades, City of Knowledge, Instituto de Investigaciones Científicas y Servicios de Alta Tecnología (INDICASAT-AIP), Panama City, PanamaCentro de Biología Celular y Molecular de las Enfermedades, City of Knowledge, Instituto de Investigaciones Científicas y Servicios de Alta Tecnología (INDICASAT-AIP), Panama City, PanamaCentro de Biología Celular y Molecular de las Enfermedades, City of Knowledge, Instituto de Investigaciones Científicas y Servicios de Alta Tecnología (INDICASAT-AIP), Panama City, PanamaCentro de Biología Celular y Molecular de las Enfermedades, City of Knowledge, Instituto de Investigaciones Científicas y Servicios de Alta Tecnología (INDICASAT-AIP), Panama City, PanamaEscuela de Psicología, Universidad Santa María La Antigua, Panama City, PanamaCentro de Biología Celular y Molecular de las Enfermedades, City of Knowledge, Instituto de Investigaciones Científicas y Servicios de Alta Tecnología (INDICASAT-AIP), Panama City, PanamaCentro de Biología Celular y Molecular de las Enfermedades, City of Knowledge, Instituto de Investigaciones Científicas y Servicios de Alta Tecnología (INDICASAT-AIP), Panama City, PanamaCentro de Biología Celular y Molecular de las Enfermedades, City of Knowledge, Instituto de Investigaciones Científicas y Servicios de Alta Tecnología (INDICASAT-AIP), Panama City, PanamaCentro de Biología Celular y Molecular de las Enfermedades, City of Knowledge, Instituto de Investigaciones Científicas y Servicios de Alta Tecnología (INDICASAT-AIP), Panama City, PanamaFacultad de Medicina, Universidad de Panamá, Panama City, PanamaCentro de Biología Celular y Molecular de las Enfermedades, City of Knowledge, Instituto de Investigaciones Científicas y Servicios de Alta Tecnología (INDICASAT-AIP), Panama City, PanamaCentro de Neurociencia, Instituto de Investigaciones Científicas y Servicios de Alta Tecnología, AIP (INDICASAT AIP), Panama City, PanamaDepartment of Research in Virology and Biotechnology, Gorgas Memorial Institute of Health Studies, Panama City, PanamaDepartment of Research in Surveillance and Biologic Risk 3, Gorgas Memorial Institute of Health Studies, Panama City, PanamaDepartment of Research in Virology and Biotechnology, Gorgas Memorial Institute of Health Studies, Panama City, PanamaDepartment of Research in Virology and Biotechnology, Gorgas Memorial Institute of Health Studies, Panama City, PanamaInstitute of Biophysics, Chinese Academy of Sciences, Beijing, ChinaBeijing Zhongke Jianlan Biotechnology Co. Ltd., Beijing, ChinaZhongke Jianlan International Medical Research Institute, Melbourne, VIC, AustraliaInstitute of Biophysics, Chinese Academy of Sciences, Beijing, ChinaBeijing Zhongke Jianlan Biotechnology Co. Ltd., Beijing, ChinaZhongke Jianlan International Medical Research Institute, Melbourne, VIC, Australia0Beijing Kewei Clinical Diagnostic Reagent Inc., Beijing, China1Centro de Vacunación e Investigación, Centro de Vacunación e Investigación Panama Clinic, Panama City, Panama1Centro de Vacunación e Investigación, Centro de Vacunación e Investigación Panama Clinic, Panama City, PanamaFacultad de Medicina, Universidad de Panamá, Panama City, Panama2Medical Research Center, Pacifica Salud, Hospital Punta Pacifica, Panama City, Panama2Medical Research Center, Pacifica Salud, Hospital Punta Pacifica, Panama City, Panama3Departamento de Microbiología Humana/Inmunología, Facultad de Medicina, Universidad de Panamá, Panama City, Panama4Servicio de Neurología. Complejo Hospitalario Dr. AAM, Universidad Nacional de Panamá, Panama City, Panama5Complejo Hospitalario Metropolitano Dr. Arnulfo Arias Madrid, Caja de Seguro Social, Panama City, Panama6Servicio de Hematología. Complejo Hospitalario Metropolitano Dr. Arnulfo Arias Madrid, Caja de Seguro Social, Panama City, Panama7Compleo Hospitalario Manuel Amador Guerrero, Caja de Seguro Social, Colón, Panama7Compleo Hospitalario Manuel Amador Guerrero, Caja de Seguro Social, Colón, Panama7Compleo Hospitalario Manuel Amador Guerrero, Caja de Seguro Social, Colón, Panama7Compleo Hospitalario Manuel Amador Guerrero, Caja de Seguro Social, Colón, Panama7Compleo Hospitalario Manuel Amador Guerrero, Caja de Seguro Social, Colón, Panama8Servicio de Hematología, Banco de Sangre. Complejo Hospitalario Metropolitano Dr. Arnulfo Arias Madrid, Caja de Seguro Social, Panama City, Panama6Servicio de Hematología. Complejo Hospitalario Metropolitano Dr. Arnulfo Arias Madrid, Caja de Seguro Social, Panama City, Panama7Compleo Hospitalario Manuel Amador Guerrero, Caja de Seguro Social, Colón, Panama9Dirección Nacional de Laboratorios Clínicos, Ministerio de Salud, Panama City, Panama0GlaxoSmithKline Vaccines, City of Knowledge, Panama City, PanamaCentro de Biología Celular y Molecular de las Enfermedades, City of Knowledge, Instituto de Investigaciones Científicas y Servicios de Alta Tecnología (INDICASAT-AIP), Panama City, PanamaCentro de Biología Celular y Molecular de las Enfermedades, City of Knowledge, Instituto de Investigaciones Científicas y Servicios de Alta Tecnología (INDICASAT-AIP), Panama City, PanamaInstitute of Biophysics, Chinese Academy of Sciences, Beijing, ChinaBeijing Zhongke Jianlan Biotechnology Co. Ltd., Beijing, ChinaZhongke Jianlan International Medical Research Institute, Melbourne, VIC, AustraliaCentro de Biología Celular y Molecular de las Enfermedades, City of Knowledge, Instituto de Investigaciones Científicas y Servicios de Alta Tecnología (INDICASAT-AIP), Panama City, PanamaNovel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the etiologic agent of the ongoing coronavirus disease 2019 (COVID-19) pandemic, which has reached 28 million cases worldwide in 1 year. The serological detection of antibodies against the virus will play a pivotal role in complementing molecular tests to improve diagnostic accuracy, contact tracing, vaccine efficacy testing, and seroprevalence surveillance. Here, we aimed first to evaluate a lateral flow assay's ability to identify specific IgM and IgG antibodies against SARS-CoV-2 and second, to report the seroprevalence estimates of these antibodies among health care workers and healthy volunteer blood donors in Panama. We recruited study participants between April 30th and July 7th, 2020. For the test validation and performance evaluation, we analyzed serum samples from participants with clinical symptoms and confirmed positive RT-PCR for SARS-CoV-2, and a set of pre-pandemic serum samples. We used two by two table analysis to determine the test positive and negative percentage agreement as well as the Kappa agreement value with a 95% confidence interval. Then, we used the lateral flow assay to determine seroprevalence among serum samples from COVID-19 patients, potentially exposed health care workers, and healthy volunteer donors. Our results show this assay reached a positive percent agreement of 97.2% (95% CI 84.2–100.0%) for detecting both IgM and IgG. The assay showed a Kappa of 0.898 (95%CI 0.811–0.985) and 0.918 (95% CI 0.839–0.997) for IgM and IgG, respectively. The evaluation of serum samples from hospitalized COVID-19 patients indicates a correlation between test sensitivity and the number of days since symptom onset; the highest positive percent agreement [87% (95% CI 67.0–96.3%)] was observed at ≥15 days post-symptom onset (PSO). We found an overall antibody seroprevalence of 11.6% (95% CI 8.5–15.8%) among both health care workers and healthy blood donors. Our findings suggest this lateral flow assay could contribute significantly to implementing seroprevalence testing in locations with active community transmission of SARS-CoV-2.https://www.frontiersin.org/articles/10.3389/fmed.2021.616106/fullCOVID-19Panamaserologybiomarkerimmunochromatographic assaydiagnosis |