Table 1.
Manufacturers and Details of Antibody Tests Approved by US Food and Drug Administration as of April 30, 2020
| Manufacturer | Test Type | Antibodies Detected | Sensitivity, % | Specificity, % |
|---|---|---|---|---|
| Cellex | Rapid test, LFIA | IgM and IgG | 93.75 | 96 |
| Ortho Clinical Diagnostics | ELISA | Total antibody (IgM and IgG) | 83.33 | 100 |
| Chembio Diagnostic System | Rapid test, LFIA | IgM and IgG | 93.55 | 93.95 |
| Mount Sinai Laboratory | ELISA | IgG only | 92.50 | 100 |
| Autobio Diagnostics | Rapid test, LFIA | IgM and IgG | 88.15 | 99.04 |
| DiaSorin | CLIA | IgG only | 70.90 | 99.27 |
| Ortho Clinical Diagnostics | ELISA | IgG only | 87.50 | 100 |
| Abbott Laboratories | CMIA | IgG only | 89.34 | 99.63 |
| Bio-Rad Laboratories | ELISA | Total (IgM, IgG, and IgA) | 92.16 | 99.56 |
| Wadsworth Center, New York State Department of Health | CMIA | Total (IgM, IgG, and IgA) | 57.84 | 98.85 |
| Average | 84.90 | 98.63 |
CLIA, chemiluminescent immunoassay; CMIA, chemiluminescent microparticle immunoassay; ELISA, enzyme-linked immunosorbent assay; LFIA, lateral flow immunoassay.