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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...

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Detalles Bibliográficos
Autores principales: Kim, Doyeong, Lee, Jihoo, Bal, Jyotiranjan, Chong, Chom-Kyu, Lee, Jong Ho, Park, Hyun
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
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
Descripción
Sumario: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.