Table 1.
Approved SARS-CoV-2 IgG Immunoassays.
| Company | Assay Name | Type | Antigen | Type of Test | Sensitivity (%) | Specificity (%) |
|---|---|---|---|---|---|---|
| Abbott Abbott Babson Diagnostics Beckman Coulter Beckman Coulter Roche Roche DiaSorin Inc. DiaSorin Inc. Beijing Wantai Beijing Wantai Beijing Wantai Euroimmun Euroimmun Euroimmun Bio-Rad Labs, Inc. BioMerieux Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Snibe Diagnostic Snibe Diagnostic Siemens Healthineers PerkinElmer Mindray Gold Standard Diagnostics Mediagnost |
SARS-CoV-2 IgG SARS-CoV-2 IgG II Semi-Quant Babson Diagnostics aC19G1 Access SARS-CoV-2 IgG Access SARS-CoV-2 IgG II Elecsys Anti-SARS-CoV-2 Elecsys Anti-SARS-CoV-2 S Liaison SARS-CoV-2 S1/S2 IgG Liaison SARS-CoV-2 Trimeric S IgG SARS-CoV-2 Total Ab Wantai SARS-CoV-2 IgG (Quantitative) Wantai SARS-CoV-2 Neutralizing Abs Anti-SARS-CoV-2 IgG Anti-SARS-CoV-2 NCP Anti-SARS-CoV-2 QuantiVac Platelia SARS-CoV-2 Total Ab Vidas SARS-COV-2 IgG Vitros Anti-SARS-CoV-2 IgG Vitros Anti-SARS-CoV-2 Total Test Maglumi 2019-nCoV (SARS-CoV-2) IgM/IgG SARS-CoV-2 S-RBD IgG SARS-CoV-2 Total Assay GSP/DELFIA Anti-SARS-CoV-2 IgG SARS-CoV-2 IgG NovaLisa® SARS-CoV-2 IgG Anti-SARS-CoV-2 IgG |
CMIA 1 CMIA CLIA 2 CLIA CLIA ECLIA 3 ECLIA CLIA CLIA ELISA 4 ELISA ELISA ELISA ELISA ELISA ELISA ELFA 5 CLIA CLIA CLIA CLIA CLIA CLIA ELISA ELISA ELISA |
N RBD ? RBD RBD N RBD S1/S2 S RBD ? - S1 N S1 N ? S S ? RBD S1 RBD S1 ? S S1 RBD |
Qualitative Semi-quantitative Qualitative Qualitative Semi-quantitative Qualitative Quantitative Quantitative Quantitative Qualitative Quantitative Quantitative Qualitative Qualitative Quantitative Semi-quantitative Qualitative Qualitative Qualitative Qualitative Qualitative Qualitative Qualitative Qualitative Qualitative Qualitative |
100 100 100 96.8 100 100 98.8 97.9 98.7 94.4 100 - 90 94.6 90.3 97.5 96.6 90 100 89–95 100 100 96.2 ? 99.9 95.3 |
99.9 99.9 100 99.6 98.9 99.8 100 98.5 99.5 100 100 - 100 99.8 99.8 99.6 99.9 100 100 96 99.6 99.8 100 ? 99.5 98.6 |
1 Chemiluminescent microparticle immunoassay. 2 Chemiluminescent immunoassay. 3 Electro-chemiluminescence immunoassay. 4 Enzyme-linked immunosorbent assay. 5 Enzyme-linked fluorescent assay. ? Not mentioned.