A high-throughput Anti-SARS-CoV-2 IgG testing platform for COVID-19

•A new immunoassay was developed for anti-SARS-CoV-2 IgG detection.•The assay is based on Luminex platform and has specificity 97.5 % for patients beyond 2 weeks after symptom onset.•Serum heat-activation is not suitable for this beads-based fluorescence immunoassay. Serology tests for detecting th...

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Bibliographic Details
Published in:Journal of virological methods 2021-01, Vol.287, p.114009-114009, Article 114009
Main Authors: Du, Jinwei, Chu, Eric, Zhang, Dayu, Lu, Chuanyi M., Zhang, Aiguo, Sha, Michael Y.
Format: Article
Language:English
Subjects:
Antibodies, Viral - blood
COVID-19
COVID-19 - blood
COVID-19 - diagnosis
COVID-19 Serological Testing - methods
High-Throughput Screening Assays
Humans
IgG test
Immunoassay
Immunoglobulin G - blood
Reproducibility of Results
SARS-CoV-2
SARS-CoV-2 - immunology
SARS-CoV-2 - isolation & purification
Sensitivity and Specificity
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Summary:•A new immunoassay was developed for anti-SARS-CoV-2 IgG detection.•The assay is based on Luminex platform and has specificity 97.5 % for patients beyond 2 weeks after symptom onset.•Serum heat-activation is not suitable for this beads-based fluorescence immunoassay. 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. 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. 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. 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.
ISSN:0166-0934
1879-0984
DOI:10.1016/j.jviromet.2020.114009