Table 4.
Serology or Antibody Tests granted FDA Emergency Use Authorization.
| Company Name | Diagnostic Product (EUA Date) | Assay Technology |
|---|---|---|
| Abbott Laboratories | SARS-CoV-2 IgG assay (04/26/2020) | Chemiluminescent microparticle immunoassay, IgG |
| Azure Biotech | Assure COVID-19 IgG/IgM Rapid Test Device (09/23/2020) | Lateral flow chromatographic immunoassay, IgG and IgM |
| Beckman Coulter | Access SARS-CoV-2 IgG assay (06/26/2020) | paramagnetic particle, chemiluminescent two-step immunoassay, IgG |
| Bio-Rad Laboratories | Platelia SARS-CoV-2 Total Ab assay (04/29/2020) | Total Antibody, Enzyme-linked immunosorbent assay |
| Cellex | qSARS-CoV-2 IgG/IgM Rapid Test (04/01/2020) | Lateral flow assay, IgG and IgM |
| DiaSorin | LIAISON SARS-CoV-2 S1/S2 IgG (04/24/2020); LIAISON SARS-CoV-2 IgM (09/29/2020) | Chemiluminescent microparticle immunoassay, IgG and IgM |
| Emory Medical Laboratories | SARS-CoV-2 RBD IgG test (06/15/2020) | Enzyme-linked immunosorbent assay, IgG |
| Hangzhou Biotest Biotech | RightSign COVID-19 IgG/IgM Rapid Test Cassette (06/04/2020) | IgG and IgM, Lateral Flow, fingerstick whole blood |
| Healgen Scientific | COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) (05/29/2020) | IgG and IgM, Lateral Flow |
| InBios International | SCoV-2 Detect IgM ELISA (06/30/2020) | IgM, Enzyme-linked immunosorbent assay |
| Mount Sinai Laboratory | COVID-19 ELISA IgG Antibody Test (04/15/2020) | IgG, Enzyme-linked immunosorbent assay |
| Ortho Clinical Diagnostics | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack (04/14/2020) | Total Antibody, Chemiluminescent microparticle immunoassay |
| Roche Diagnostics | Elecsys Anti-SARS-CoV-2 (05/02/2020) | Total Antibody, Electrochemiluminescence immunoassay |
| Siemens Healthcare Diagnostics Inc. | Dimension Vista SARS-CoV-2 Total antibody assay (COV2T) (06/08/2020) | Total Antibody, Chemiluminescent microparticle immunoassay |
| Thermo Fisher Scientific | OmniPATH COVID-19 Total Antibody ELISA Test (10/02/2020) | Total Antibodys(including IgM, IgA and IgG to SARS-CoV-2), ELISA |
| Vibrant America Clinical Labs | Vibrant COVID-19 Ab Assay (06/04/2020) | IgG and IgM, Chemiluminescent microparticle immunoassay |
| Wadsworth Center, New York | New York SARS-CoV Microsphere Immunoassay for Antibody Detection (04/30/2020) | Total Antibody, Fluorescent microsphere Immunoassay |
|
Specimen Types: human serum, plasma, fingerstick whole blood or venous whole blood; Approved FDA EUA Use: human SARS-CoV-2 IgM (immunoglobulin-M), IgG (immunoglobulin-G), and total antibodies | ||