The pandemic of novel coronavirus disease COVID-19 is rapidly expanding across the world. A positive result of antibody tests suggests that the individual has potentially been exposed to SARS-CoV-2, thus allowing to identify asymptomatic infections and determine the seroprevalence in a given population. The aim of this study was to evaluate the performances of a newly developed high throughput immunoassay for anti-SARS-CoV-2 IgM antibody detection on the Luminex MAGPIX platform. Clinical agreement studies were performed in 42 COVID-19 patient serum samples and 162 negative donor serum/plasma samples. Positive percent agreement (PPA) was 42.86% (95% CI: 9.90% to 81.59%), 71.43% (95% CI: 29.04% to 96.33%), and 28.57% (95% CI: 13.22% to 48.67%) for samples collected on 0–7 days, 8–14 days, and 2–8 weeks from symptom onset, respectively. Negative Percent Agreement (NPA) was 97.53% (95% CI: 93.80% to 99.32%). There was no cross-reactivity with the SARS-CoV-2 IgG antibody. Hemoglobin (200 mg/dL), bilirubin (2 mg/dL), triglyceride (250 mg/dL) and EDTA (10 mM) showed no significant interfering effect on this assay. In conclusion, an anti-SARS-CoV-2 IgM antibody assay with high sensitivity and specificity has been developed. With the high throughput, this assay will speed up the anti-SARS-CoV-2 IgM testing.
【초록키워드】 COVID-19, SARS-CoV-2, pandemic, antibody, novel coronavirus disease, cross-reactivity, immunoassay, IgG antibody, Antibody detection, Sensitivity and specificity, clinical, asymptomatic infection, Triglyceride, Antibody test, agreement, platform, anti-SARS-CoV-2 IgM, Donor, Bilirubin, symptom onset, positive result, serum/plasma, EDTA, COVID-19 patient serum, negative, identify, performed, collected, evaluate, determine, the SARS-CoV-2, 【제목키워드】 COVID-19, diagnostics, immunoassay, anti-SARS-CoV-2 IgM,