Highlights • A new immunoassay was developed for anti-SARS-CoV-2 IgG detection. • The assay is based on Luminex platform and has specificity <98 %. • The assay shows sensitivity > 97.5 % for patients beyond 2 weeks after symptom onset. • Serum heat-activation is not suitable for this beads-based fluorescence immunoassay. Background Serology tests for detecting the antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can identify previous infection and help to confirm the presence of current infection. Objective The aim of this study was to evaluate the performances of a newly developed high throughput immunoassay for anti-SARS-CoV-2 IgG antibody detection. Results Clinical agreement studies were performed in 107 COVID-19 patient serum samples and 226 negative donor serum/plasma samples. Positive percent agreement (PPA) was 46.15 % (95 % CI: 19.22 % ∼74.87 %), 61.54 % (95 % CI: 31.58 % ∼86.14 %), and 97.53 % (95 % CI: 91.36 % ∼99.70 %) for samples collected on 0−7 days, 8−14 days, and ≥15 days from symptom onset, respectively. Negative Percent Agreement (NPA) was 98.23 % (95 % CI: 95.53 % ∼99.52 %). No cross-reactivity was observed to patient samples positive for IgG antibodies against the following pathogens: HIV, HAV, HBV, RSV, CMV, EBV, Rubella, Influenza A, and Influenza B . Hemoglobin (200 mg/dL), bilirubin (2 mg/dL) and EDTA (10 mM) showed no significant interfering effect on this assay. Conclusion An anti-SARS-CoV-2 IgG antibody assay with high sensitivity and specificity has been developed. With the high throughput, this assay will speed up anti-SARS-CoV-2 IgG testing.
【저자키워드】 COVID-19, SARS-CoV-2, immunoassay, IgG test, 【초록키워드】 HIV, coronavirus, antibody, Infection, HBV, cross-reactivity, sensitivity, specificity, IgG antibody, Antibody detection, Sensitivity and specificity, RSV, anti-SARS-CoV-2 IgG, clinical, Patient, CMV, agreement, EBV, Donor, Bilirubin, rubella, symptom onset, acute respiratory syndrome, help, serum/plasma, EDTA, positive, COVID-19 patient serum, negative, objective, Luminex platform, Result, identify, performed, collected, evaluate, HAV, the antibody, 【제목키워드】 IgG, platform,