Table 1.
Tests for anti-SARS-CoV-2 antibodies.
| Tests Acceptable for Use in the Manufacture of High Titer COVID-19 Convalescent Plasma | ||
|---|---|---|
| Manufacturer (listed alphabetically) | Assay | Qualifying Result |
| Abbott | SARS-CoV-2 IgG (ARCHITECT and Alinity i) | Index (S/C) ≥ 4.5 |
| Beckman Coulter | Access SARS-CoV-2 IgG | S/CO ≥ 3.3 |
| EUROIMMUN | Anti-SARS-CoV-2 ELISA (IgG) | Ratio ≥ 3.5 |
| GenScript | cPass SARS-CoV-2 Neutralization Antibody Detection Kit | Inhibition ≥ 68% |
| Kantaro | COVID-SeroKlir, Kantaro SemiQuantitative SARSCoV-2 IgG Antibody Kit | Spike ELISA > 47 AU/mL |
| Mount Sinai | COVID-19 ELISA IgG | Spike ELISA titer ≥ 1:2880 |
| Ortho | VITROS Anti-SARSCoV-2 IgG | S/C ≥ 9.5 |
| Roche | Elecsys Anti-SARSCoV-2 | ≥ 132 U/mL |
| Siemens | ADVIA Centaur SARS-CoV-2 IgG (COV2G) | Index ≥ 4.8 |
Source: Hinton-FDA, 2021.