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Performance estimation of two in-house ELISA assays for COVID-19 surveillance through the combined detection of anti-SARS-CoV-2 IgA, IgM, and IgG immunoglobulin isotypes

The main objective of this study was to estimate the performance, under local epidemiological conditions, of two in-house ELISA assays for the combined detection of anti-SARS-CoV-2 IgA, IgM, and IgG immunoglobulins. A total of 94 serum samples were used for the assessment, where 44 corresponded to s...

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Autores principales: Ramírez-Reveco, Alfredo, Velásquez, Gerardo, Aros, Christopher, Navarrete, Gabriela, Villarroel-Espíndola, Franz, Navarrete, Maritza, Fica, Alberto, Plaza, Anita, Castro, Natalia, Verdugo, Claudio, Acosta-Jamett, Gerardo, Verdugo, Cristóbal C.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9901778/
https://www.ncbi.nlm.nih.gov/pubmed/36745590
http://dx.doi.org/10.1371/journal.pone.0270388
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author Ramírez-Reveco, Alfredo
Velásquez, Gerardo
Aros, Christopher
Navarrete, Gabriela
Villarroel-Espíndola, Franz
Navarrete, Maritza
Fica, Alberto
Plaza, Anita
Castro, Natalia
Verdugo, Claudio
Acosta-Jamett, Gerardo
Verdugo, Cristóbal C.
author_facet Ramírez-Reveco, Alfredo
Velásquez, Gerardo
Aros, Christopher
Navarrete, Gabriela
Villarroel-Espíndola, Franz
Navarrete, Maritza
Fica, Alberto
Plaza, Anita
Castro, Natalia
Verdugo, Claudio
Acosta-Jamett, Gerardo
Verdugo, Cristóbal C.
author_sort Ramírez-Reveco, Alfredo
collection PubMed
description The main objective of this study was to estimate the performance, under local epidemiological conditions, of two in-house ELISA assays for the combined detection of anti-SARS-CoV-2 IgA, IgM, and IgG immunoglobulins. A total of 94 serum samples were used for the assessment, where 44 corresponded to sera collected before the pandemic (free of SARS-CoV-2 antibodies), and 50 sera were collected from confirmed COVID-19 patients admitted to the main public hospital in the city of Valdivia, southern Chile. The Nucleocapsid (Np) and the receptor-binding domain (RBD) proteins were separately used as antigens (Np and RBD ELISA, respectively) to assess their diagnostic performance. A receiver operating characteristic (ROC) analysis was performed to estimate the optical density (OD) cut-off that maximized the sensitivity (Se) and specificity (Sp) of the ELISA assays. Np ELISA had a mean Se of 94% (95% CI = 83.5–98.8%) and a mean Sp of 100% (95% CI = 92.0–100%), with an OD 450 nm positive cut-off value of 0.88. On the other hand, RBD ELISA presented a mean Se of 96% (95% CI = 86.3–99.5%) and a mean Sp of 90% (95% CI = 78.3–97.5%), with an OD 450 nm positive cut off value of 0.996. Non-significant differences were observed between the Se distributions of Np and RBD ELISAs, but the latter presented a significant lower Sp than Np ELISA. In parallel, collected sera were also analyzed using a commercial lateral flow chromatographic immunoassay (LFCI), to compare the performance of the in-house ELISA assays against a commercial test. The LFCI had a mean sensitivity of 94% (95% CI = 87.4–100%) and a mean specificity of 100% (95% CI = 100–100%). When compared to Np ELISA, non-significant differences were observed on the performance distributions. Conversely, RBD ELISA had a significant lower Sp than the LFCI. Although, Np ELISA presented a similar performance to the commercial test, this was 2.5 times cheaper than the LFCI assay (labor cost not considered). Thus, the in-house Np ELISA could be a suitable alternative tool, in resource limited environments, for the surveillance of SARS-CoV-2 infection, supporting further epidemiological studies.
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spelling pubmed-99017782023-02-07 Performance estimation of two in-house ELISA assays for COVID-19 surveillance through the combined detection of anti-SARS-CoV-2 IgA, IgM, and IgG immunoglobulin isotypes Ramírez-Reveco, Alfredo Velásquez, Gerardo Aros, Christopher Navarrete, Gabriela Villarroel-Espíndola, Franz Navarrete, Maritza Fica, Alberto Plaza, Anita Castro, Natalia Verdugo, Claudio Acosta-Jamett, Gerardo Verdugo, Cristóbal C. PLoS One Research Article The main objective of this study was to estimate the performance, under local epidemiological conditions, of two in-house ELISA assays for the combined detection of anti-SARS-CoV-2 IgA, IgM, and IgG immunoglobulins. A total of 94 serum samples were used for the assessment, where 44 corresponded to sera collected before the pandemic (free of SARS-CoV-2 antibodies), and 50 sera were collected from confirmed COVID-19 patients admitted to the main public hospital in the city of Valdivia, southern Chile. The Nucleocapsid (Np) and the receptor-binding domain (RBD) proteins were separately used as antigens (Np and RBD ELISA, respectively) to assess their diagnostic performance. A receiver operating characteristic (ROC) analysis was performed to estimate the optical density (OD) cut-off that maximized the sensitivity (Se) and specificity (Sp) of the ELISA assays. Np ELISA had a mean Se of 94% (95% CI = 83.5–98.8%) and a mean Sp of 100% (95% CI = 92.0–100%), with an OD 450 nm positive cut-off value of 0.88. On the other hand, RBD ELISA presented a mean Se of 96% (95% CI = 86.3–99.5%) and a mean Sp of 90% (95% CI = 78.3–97.5%), with an OD 450 nm positive cut off value of 0.996. Non-significant differences were observed between the Se distributions of Np and RBD ELISAs, but the latter presented a significant lower Sp than Np ELISA. In parallel, collected sera were also analyzed using a commercial lateral flow chromatographic immunoassay (LFCI), to compare the performance of the in-house ELISA assays against a commercial test. The LFCI had a mean sensitivity of 94% (95% CI = 87.4–100%) and a mean specificity of 100% (95% CI = 100–100%). When compared to Np ELISA, non-significant differences were observed on the performance distributions. Conversely, RBD ELISA had a significant lower Sp than the LFCI. Although, Np ELISA presented a similar performance to the commercial test, this was 2.5 times cheaper than the LFCI assay (labor cost not considered). Thus, the in-house Np ELISA could be a suitable alternative tool, in resource limited environments, for the surveillance of SARS-CoV-2 infection, supporting further epidemiological studies. Public Library of Science 2023-02-06 /pmc/articles/PMC9901778/ /pubmed/36745590 http://dx.doi.org/10.1371/journal.pone.0270388 Text en © 2023 Ramírez-Reveco et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Ramírez-Reveco, Alfredo
Velásquez, Gerardo
Aros, Christopher
Navarrete, Gabriela
Villarroel-Espíndola, Franz
Navarrete, Maritza
Fica, Alberto
Plaza, Anita
Castro, Natalia
Verdugo, Claudio
Acosta-Jamett, Gerardo
Verdugo, Cristóbal C.
Performance estimation of two in-house ELISA assays for COVID-19 surveillance through the combined detection of anti-SARS-CoV-2 IgA, IgM, and IgG immunoglobulin isotypes
title Performance estimation of two in-house ELISA assays for COVID-19 surveillance through the combined detection of anti-SARS-CoV-2 IgA, IgM, and IgG immunoglobulin isotypes
title_full Performance estimation of two in-house ELISA assays for COVID-19 surveillance through the combined detection of anti-SARS-CoV-2 IgA, IgM, and IgG immunoglobulin isotypes
title_fullStr Performance estimation of two in-house ELISA assays for COVID-19 surveillance through the combined detection of anti-SARS-CoV-2 IgA, IgM, and IgG immunoglobulin isotypes
title_full_unstemmed Performance estimation of two in-house ELISA assays for COVID-19 surveillance through the combined detection of anti-SARS-CoV-2 IgA, IgM, and IgG immunoglobulin isotypes
title_short Performance estimation of two in-house ELISA assays for COVID-19 surveillance through the combined detection of anti-SARS-CoV-2 IgA, IgM, and IgG immunoglobulin isotypes
title_sort performance estimation of two in-house elisa assays for covid-19 surveillance through the combined detection of anti-sars-cov-2 iga, igm, and igg immunoglobulin isotypes
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9901778/
https://www.ncbi.nlm.nih.gov/pubmed/36745590
http://dx.doi.org/10.1371/journal.pone.0270388
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