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KMID : 1100820210110040275
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Laboratory Medicine Online
2021 Volume.11 No. 4 p.275 ~ p.282
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Evaluation of Clinical and Analytical Performance of a Nucleocapsid Protein Antigen-based ELISA for Detecting Antibodies against SARS-CoV-2
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Suh In-Bum
Kim Ha-Na
Kim Chae-Eun
Park Jong-Chan
Kim Soo-Hyun
Mihn Do-Cic
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Abstract
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Background: As the coronavirus disease 2019 (COVID-19) pandemic evolves, the development of immunoassays that will help assess population exposure and potentially predict immunity has become a pressing priority.
Methods: We evaluated the performance of the R-FIND COVID-19 enzyme-linked immunosorbent assay (ELISA) (SG Medical. Inc., Korea) for semi-quantitative detection of IgG, IgM, and IgG/M/A total antibodies in serum samples, using the SARS-CoV-2 nucleocapsid protein as antigen. Serum samples from 87 patients with COVID-19 were tested for IgG and IgG/M/A. Samples from 19 patients were tested for IgM. Specimens from 160 patients without COVID-19 served as negative controls. Analytical performance was evaluated according to Ministry of Food and Drug Safety guidelines. Sensitivity and specificity were the primary measures of clinical performance.
Results: The analytical performance of the R-FIND COVID-19 ELISA met Ministry guidelines. Sensitivity and specificity were 94.25% and 98.13% for IgG, 95.40% and 98.13% for IgG/M/A, and 84.21% and 100% for IgM, respectively. IgM showed a 100% positive rate within 1 week of hospitalization, then decreased. IgG and IgG/M/A antibodies displayed 100% positivity after 2 weeks. IgG and IgG/M/A antibody titers steadily increased throughout patient hospitalization, but IgM titers gradually decreased.
Conclusions: The R-FIND COVID-19 ELISA detects IgG, IgM, and IgG/M/A and displays excellent analytical performance, sensitivity, and specificity. IgG titers increased steadily throughout hospitalization, but IgM titers peaked at one week post-hospitalization, and then steadily declined.
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KEYWORD
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COVID-19, SARS-CoV-2, Antibodies, ELISA, Serology
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