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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7968482/ https://www.ncbi.nlm.nih.gov/pubmed/33748157 http://dx.doi.org/10.3389/fmed.2021.616106 |
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author | Villarreal, Alcibiades Rangel, Giselle Zhang, Xu Wong, Digna Britton, Gabrielle Fernandez, Patricia L. Pérez, Ambar Oviedo, Diana Restrepo, Carlos Carreirra, María B. Sambrano, Dilcia Eskildsen, Gilberto A. De La Guardia, Carolina Flores-Cuadra, Julio Carrera, Jean-Paul Zaldivar, Yamitzel Franco, Danilo López-Vergès, Sandra Zhang, Dexi Fan, Fangjing Wang, Baojun Sáez-Llorens, Xavier DeAntonio, Rodrigo Torres-Atencio, Ivonne Blanco, Isabel Subía, Fernando Diaz Mudarra, Laiss Benzadon, Aron Valverde, Walter López, Lineth Hurtado, Nicolás Rivas, Neyla Jurado, Julio Carvallo, Aixa Rodriguez, Juan Perez, Yaseikiry Morris, Johanna Luque, Odemaris Cortez, David Ortega-Barria, Eduardo Kosagisharaf, Rao Lleonart, Ricardo Li, Chong Goodridge, Amador |
author_facet | Villarreal, Alcibiades Rangel, Giselle Zhang, Xu Wong, Digna Britton, Gabrielle Fernandez, Patricia L. Pérez, Ambar Oviedo, Diana Restrepo, Carlos Carreirra, María B. Sambrano, Dilcia Eskildsen, Gilberto A. De La Guardia, Carolina Flores-Cuadra, Julio Carrera, Jean-Paul Zaldivar, Yamitzel Franco, Danilo López-Vergès, Sandra Zhang, Dexi Fan, Fangjing Wang, Baojun Sáez-Llorens, Xavier DeAntonio, Rodrigo Torres-Atencio, Ivonne Blanco, Isabel Subía, Fernando Diaz Mudarra, Laiss Benzadon, Aron Valverde, Walter López, Lineth Hurtado, Nicolás Rivas, Neyla Jurado, Julio Carvallo, Aixa Rodriguez, Juan Perez, Yaseikiry Morris, Johanna Luque, Odemaris Cortez, David Ortega-Barria, Eduardo Kosagisharaf, Rao Lleonart, Ricardo Li, Chong Goodridge, Amador |
author_sort | Villarreal, Alcibiades |
collection | PubMed |
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. |
format | Online Article Text |
id | pubmed-7968482 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-79684822021-03-18 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 Villarreal, Alcibiades Rangel, Giselle Zhang, Xu Wong, Digna Britton, Gabrielle Fernandez, Patricia L. Pérez, Ambar Oviedo, Diana Restrepo, Carlos Carreirra, María B. Sambrano, Dilcia Eskildsen, Gilberto A. De La Guardia, Carolina Flores-Cuadra, Julio Carrera, Jean-Paul Zaldivar, Yamitzel Franco, Danilo López-Vergès, Sandra Zhang, Dexi Fan, Fangjing Wang, Baojun Sáez-Llorens, Xavier DeAntonio, Rodrigo Torres-Atencio, Ivonne Blanco, Isabel Subía, Fernando Diaz Mudarra, Laiss Benzadon, Aron Valverde, Walter López, Lineth Hurtado, Nicolás Rivas, Neyla Jurado, Julio Carvallo, Aixa Rodriguez, Juan Perez, Yaseikiry Morris, Johanna Luque, Odemaris Cortez, David Ortega-Barria, Eduardo Kosagisharaf, Rao Lleonart, Ricardo Li, Chong Goodridge, Amador Front Med (Lausanne) Medicine 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. Frontiers Media S.A. 2021-03-02 /pmc/articles/PMC7968482/ /pubmed/33748157 http://dx.doi.org/10.3389/fmed.2021.616106 Text en Copyright © 2021 Villarreal, Rangel, Zhang, Wong, Britton, Fernandez, Pérez, Oviedo, Restrepo, Carreirra, Sambrano, Eskildsen, De La Guardia, Flores-Cuadra, Carrera, Zaldivar, Franco, López-Vergès, Zhang, Fan, Wang, Sáez-Llorens, DeAntonio, Torres-Atencio, Blanco, Subía, Mudarra, Benzadon, Valverde, López, Hurtado, Rivas, Jurado, Carvallo, Rodriguez, Perez, Morris, Luque, Cortez, Ortega-Barria, Kosagisharaf, Lleonart, Li and Goodridge. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Medicine Villarreal, Alcibiades Rangel, Giselle Zhang, Xu Wong, Digna Britton, Gabrielle Fernandez, Patricia L. Pérez, Ambar Oviedo, Diana Restrepo, Carlos Carreirra, María B. Sambrano, Dilcia Eskildsen, Gilberto A. De La Guardia, Carolina Flores-Cuadra, Julio Carrera, Jean-Paul Zaldivar, Yamitzel Franco, Danilo López-Vergès, Sandra Zhang, Dexi Fan, Fangjing Wang, Baojun Sáez-Llorens, Xavier DeAntonio, Rodrigo Torres-Atencio, Ivonne Blanco, Isabel Subía, Fernando Diaz Mudarra, Laiss Benzadon, Aron Valverde, Walter López, Lineth Hurtado, Nicolás Rivas, Neyla Jurado, Julio Carvallo, Aixa Rodriguez, Juan Perez, Yaseikiry Morris, Johanna Luque, Odemaris Cortez, David Ortega-Barria, Eduardo Kosagisharaf, Rao Lleonart, Ricardo Li, Chong Goodridge, Amador 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 | 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_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_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 |
topic | Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7968482/ https://www.ncbi.nlm.nih.gov/pubmed/33748157 http://dx.doi.org/10.3389/fmed.2021.616106 |
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