Table 3. Diagnostic Tests Approved for COVID-19 in the USA as per FDA.
| Company/method of testing | Country of development | Sensitivity and specificity of the test |
|---|---|---|
| Mount Sinai laboratory COVID-19 ELISA IgG antibody test/ELISA | USA | Not available |
| VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack/Total Calibrator (Ortho Clinical Diagnostics)/Modified ELISA | USA | Sensitivity: 83%, specificity: 100% |
| Cellex/RDT | USA/China | Sensitivity: 93.8%, specificity: 95.6% |
| ChemBio/RDT | USA | Not available |
| Epitope Diagnostics, Ltd/ELISA | USA | Not available |
| BioMedomics/RDT for research use only | USA | Sensitivity: 88.66%, specificity: 90.63% |
| Ray Biotech/RDT for research use only | USA | Not available |
| Emory University/ELISA for research use only | USA | Not available |
ELISA: enzyme-linked immunosorbent assay; COVID-19: coronavirus disease 2019; FDA: Food and Drug Administration; IgG: immunoglobulin G; RDT: rapid diagnostic test.