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Clinical Evaluation of an Immunochromatographic-Based IgM/IgG Antibody Assay (GenBody™ COVI040) for Detection of Antibody Seroconversion in Patients with SARS-CoV-2 Infection
There is a need for accurate diagnostic tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease (COVID-19). This study aimed to evaluate the diagnostic accuracy of an immunochromatography-based immunoglobulin G (IgG)/immunoglobulin M (IgM) antibody as...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8002734/ https://www.ncbi.nlm.nih.gov/pubmed/33802842 http://dx.doi.org/10.3390/diagnostics11030537 |
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author | Kim, Doyeong Lee, Jihoo Bal, Jyotiranjan Chong, Chom-Kyu Lee, Jong Ho Park, Hyun |
author_facet | Kim, Doyeong Lee, Jihoo Bal, Jyotiranjan Chong, Chom-Kyu Lee, Jong Ho Park, Hyun |
author_sort | Kim, Doyeong |
collection | PubMed |
description | There is a need for accurate diagnostic tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease (COVID-19). This study aimed to evaluate the diagnostic accuracy of an immunochromatography-based immunoglobulin G (IgG)/immunoglobulin M (IgM) antibody assay (GenBody™ COVI040) for detecting SARS-CoV-2 antibody seroconversion in COVID-19 patients. A total of 130 samples, serially collected from patients with confirmed COVID-19, and 100 negative control samples were tested for anti-SARS-CoV-2 IgM and IgG using the GenBody™ COVI040 assay following the South Korean Ministry of Food and Drug Safety guidelines on the review and approval of in vitro diagnostic devices for COVID-19. Reverse-transcription polymerase chain reaction results were used as the comparator. The overall sensitivity of the GenBody™ COVI040 assay was 97.69% (95% confidence interval (CI): 93.40–99.52%). The sensitivity of the assay increased with time post symptom onset (PSO) (sensitivity ≤6 days PSO: 78.57%, 95% CI: 49.20–95.34%; sensitivity 7–13 days PSO: 100%, 95% CI: 87.23–100%; and sensitivity ≥14 days PSO: 100%, 95% CI: 95.94–100%). The specificity of the assay was 100% (95% CI: 96.38–100%). The GenBody™ COVI040 assay showed high sensitivity and specificity, making it a promising diagnostic test to monitor COVID-19. |
format | Online Article Text |
id | pubmed-8002734 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-80027342021-03-28 Clinical Evaluation of an Immunochromatographic-Based IgM/IgG Antibody Assay (GenBody™ COVI040) for Detection of Antibody Seroconversion in Patients with SARS-CoV-2 Infection Kim, Doyeong Lee, Jihoo Bal, Jyotiranjan Chong, Chom-Kyu Lee, Jong Ho Park, Hyun Diagnostics (Basel) Article There is a need for accurate diagnostic tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease (COVID-19). This study aimed to evaluate the diagnostic accuracy of an immunochromatography-based immunoglobulin G (IgG)/immunoglobulin M (IgM) antibody assay (GenBody™ COVI040) for detecting SARS-CoV-2 antibody seroconversion in COVID-19 patients. A total of 130 samples, serially collected from patients with confirmed COVID-19, and 100 negative control samples were tested for anti-SARS-CoV-2 IgM and IgG using the GenBody™ COVI040 assay following the South Korean Ministry of Food and Drug Safety guidelines on the review and approval of in vitro diagnostic devices for COVID-19. Reverse-transcription polymerase chain reaction results were used as the comparator. The overall sensitivity of the GenBody™ COVI040 assay was 97.69% (95% confidence interval (CI): 93.40–99.52%). The sensitivity of the assay increased with time post symptom onset (PSO) (sensitivity ≤6 days PSO: 78.57%, 95% CI: 49.20–95.34%; sensitivity 7–13 days PSO: 100%, 95% CI: 87.23–100%; and sensitivity ≥14 days PSO: 100%, 95% CI: 95.94–100%). The specificity of the assay was 100% (95% CI: 96.38–100%). The GenBody™ COVI040 assay showed high sensitivity and specificity, making it a promising diagnostic test to monitor COVID-19. MDPI 2021-03-17 /pmc/articles/PMC8002734/ /pubmed/33802842 http://dx.doi.org/10.3390/diagnostics11030537 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) ). |
spellingShingle | Article Kim, Doyeong Lee, Jihoo Bal, Jyotiranjan Chong, Chom-Kyu Lee, Jong Ho Park, Hyun Clinical Evaluation of an Immunochromatographic-Based IgM/IgG Antibody Assay (GenBody™ COVI040) for Detection of Antibody Seroconversion in Patients with SARS-CoV-2 Infection |
title | Clinical Evaluation of an Immunochromatographic-Based IgM/IgG Antibody Assay (GenBody™ COVI040) for Detection of Antibody Seroconversion in Patients with SARS-CoV-2 Infection |
title_full | Clinical Evaluation of an Immunochromatographic-Based IgM/IgG Antibody Assay (GenBody™ COVI040) for Detection of Antibody Seroconversion in Patients with SARS-CoV-2 Infection |
title_fullStr | Clinical Evaluation of an Immunochromatographic-Based IgM/IgG Antibody Assay (GenBody™ COVI040) for Detection of Antibody Seroconversion in Patients with SARS-CoV-2 Infection |
title_full_unstemmed | Clinical Evaluation of an Immunochromatographic-Based IgM/IgG Antibody Assay (GenBody™ COVI040) for Detection of Antibody Seroconversion in Patients with SARS-CoV-2 Infection |
title_short | Clinical Evaluation of an Immunochromatographic-Based IgM/IgG Antibody Assay (GenBody™ COVI040) for Detection of Antibody Seroconversion in Patients with SARS-CoV-2 Infection |
title_sort | clinical evaluation of an immunochromatographic-based igm/igg antibody assay (genbody™ covi040) for detection of antibody seroconversion in patients with sars-cov-2 infection |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8002734/ https://www.ncbi.nlm.nih.gov/pubmed/33802842 http://dx.doi.org/10.3390/diagnostics11030537 |
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