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 assay (GenBody (TM) 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 (TM) 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 (TM) 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 (TM) COVI040 assay showed high sensitivity and specificity, making it a promising diagnostic test to monitor COVID-19.

Automated summary

This study evaluated the diagnostic accuracy of an immunochromatography-based immunoglobulin G (IgG)/immunoglobulin M (IgM) antibody assay (GenBody (TM) COVI040) for detecting SARS-CoV-2 antibody seroconversion in COVID-19 patients. The assay showed high sensitivity and specificity, making it a promising diagnostic test to monitor COVID-19.