Table 1.
Selected approved CLIA-based tests as Lab-based and high throughput COVID-19 detection strategies based on FDA Serology Test Performance [44].
| Company | Test | Technology | Target | Antigen | Sensitivity (Day 15 after Symptom Onset) | Specificity | Throughput |
|---|---|---|---|---|---|---|---|
| Ortho Clinical Diagnostics, Inc. | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack | CLIA | Total Antibody | S | 100% | 100% | 150 tests/h with one result in 48 min |
| Beckman Coulter, Inc. | Access SARS-CoV-2 IgG | Automated CLIA | IgG | S | 96.8% | 99.6% | 50–200 tests/h |
| Babson Diagnostics, Inc. | Babson Diagnostics aC19G1 | Fully Automated CLIA | IgG | S | 100% | 100% | 440 tests/h |
| Ortho Clinical Diagnostics, Inc. | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack | CLIA | IgG | S | 90.0% | 100% | 150 tests/h |
| Siemens Healthcare Diagnostics Inc. | ADVIA Centaur SARS-CoV-2 Total (COV2T) | Automated-Semi-quantitative CMIA | Total Antibody | S | 100% | 99.8% | 240 samples/h with one result in 18 min |
| Siemens Healthcare Diagnostics Inc. | Atellica IM SARS-CoV-2 Total (COV2T) | Automated CMIA | Total Antibody | S | 100% | 99.8% | 440 tests/h with one result in 10 min |
| DiaSorin | LIAISON SARS-CoV-2 S1/S2 IgG | Complex Automated CLIA | IgG | S (S1/S2) | 97.6% | 99.3% | 170 tests/h and 35 min time to first result |
| Vibrant America Clinical Labs | Vibrant COVID-19 Ab Assay | CLIA | IgM and IgG | S and N | 98.1% | 98.6% | 24–36 h |
| SNIBE Diagnostic | MAGLUMI 2019-nCoV IgM/IgG | Automated CLIA | IgM and IgG | S and N | 64.3% | 100% | 30 min for one test |
| Diazyme Laboratories, Inc. | Diazyme SARS-CoV-2 IgM CLIA test | CLIA | IgM | S and N | 94.4% | 98.3% | 50 tests/h |
| Diazyme Laboratories, Inc. | Diazyme DZ-Lite SARS-CoV-2 IgG CLIA Kit | Automated CLIA | IgG | S and N | 100% | 97.4% | 50 tests/h |
| Roche Diagnostics | Elecsys Anti-SARS-CoV-2 | ECLIA | Total Antibody | N | 100% | 99.8% | 300 tests/h |
| Abbott Laboratories Inc. | Architect SARS-CoV-2 IgG | CMIA | IgG | N | 100% | 99.6% | 100 samples in 70 min |
| Abbott Laboratories Inc. | Alinity i SARS-CoV-2 IgG | CMIA | IgG | N | 100% | 99.0% | 4000 tests in 24 h, with a 29 min time to first result |