TABLE 1.
Attributes for the evaluated anti-SARS-CoV-2 IgG serologic assaysa
| Attribute | Data for: |
|||
|---|---|---|---|---|
| Abbott | Epitope | Euroimmun | Ortho-Clinical | |
| Assay principleb | CMIA | ELISA | ELISA | CLIA |
| Solid-phase antigen | Nucleocapsid | Nucleocapsid | Spike S1 | Spike |
| Specimen type | Serum, plasma | Serum | Serum | Serum |
| Sample volume | 25 μl | 10 μl | 10 μl | 20 μl |
| EUA status | Granted | Submitted | Granted | Granted |
| Result calculation | Index (S/Co) | Index (S/Co) | Index (S/Co) | Index (S/Co) |
| Positive cutoff threshold | ≥1.4 | ≥1.21c | ≥1.1 | ≥1.00 |
| Indeterminate cutoff range | NA | ≥1.01 to <1.21c | ≥0.8 to <1.1 | NA |
| Operational type | Continuous, random access | Batch | Batch | Continuous, random access |
| Time to first result | 29 min | 80 min | 120 min | 48 min |
| Test throughput per 8 h | 1,600 | 630c | 630d | 1,040 to 1,200 |
Abbreviations: CMIA, chemiluminescent microparticle immunoassay; ELISA, enzyme-linked immunosorbent assay; CLIA, chemiluminescence immunoassay; EUA, emergency use authorization; S/Co, signal-to-cutoff; NA, not applicable.
All assays are indirect in format.
Laboratory-determined cutoff threshold.
Testing performed on the Dynex Agility automated ELISA processor (Chantilly, VA).