Antibody Equipment-based
Updated as of 17 May 2023
results
| # | Rapid Antibody Test Kits | Manufacturer | IgM Clinical Sensitivity (95% CI) | IgM Clinical Specificity (95% CI) | IgG Clinical Sensitivity (95% CI) | IgG Clinical Specificity (95% CI) | OVERALL | Date Performed | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 8-14 | Day 15-21 | Day ≥ 22 | TOTAL | Day 8-14 | Day 15-21 | Day ≥ 22 | TOTAL | SENSITIVITY | SPECIFICITY | ||||||
| 1 | MAGLUMI 2019-nCoV IgM/IgG (CLIA) | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 96% (79.65 to 99.90) | 92% (73.97 to 99.02) | 92% (73.97 to 99.02) | 93.33% (85.12 to 97.80) | 92% (83.40 to 97.01) | 76% (54.87 to 90.64) | 72% (50.61 to 87.93) | 80% (59.30 to 93.17) | 76% (64.75 to 85.11) | 97.33% (90.70 to 99.68) | 84.67% (77.89 to 90.02) | 92.67% (87.17 to 96.26) | November 23-27, 2020 |
| 2 | Elecsys Anti-SARS-CoV-2 (300 tests, for use in cobas e 801/200 tests, for use in cobas e 411, e 601, e 602) | Roche Diagnostic GmbH | 96% (80.36 to 99.90) | 80% (59.30 to 93.17) | 100% (86.28 to 100) | 92% (83.40 to 97.01) | 100% (95.20 to 100) | 96% (80.36 to 99.90) | 80% (59.30 to 93.17) | 100% (86.28 to 100) | 92% (83.40 to 97.01) | 100% (95.20 to 100) | 92% (83.40 to 97.01) | 100% (95.20 to 100) | November 25-27, 2020 |
| 3 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG | Ortho-Clinical Diagnostics, Inc. | – | – | – | – | – | 100% (86.28 to 100) | 100% (86.28 to 100) | 100% (86.28 to 100) | 100% (86.28 to 100) | 98.67% (92.79 to 99.97) | 100% (95.20 to 100) | 98.67% (92.79 to 99.7) | |
| 4 | VITROS Anti-SARS-CoV-2 Total Assay | Ortho-Clinical Diagnostics, Inc. | 100% (86.28 to 100) | 100% (86.28 to 100) | 100% (86.28 to 100) | 100% (86.28 to 100) | 98.67% (92.79 to 99.97) | 100% (86.28 to 100) | 100% (86.28 to 100) | 100% (86.28 to 100) | 100% (86.28 to 100) | 98.67% (92.79 to 99.97) | 100% (95.20 to 100) | 98.67% (92.79 to 99.7) | |
| 5 | LIAISON SARS-CoV-2 IgM Assay | Diasorin Italia S.p.A | 96.15 (80.36 to 99.90) | 80.00% (59.30 to 93.17) | 100% (86.28 to 100) | 92.00 (83.40 to 97.01) | 100% (95.20 to 100) | 92.00% (83.40 to 97.01) | 100% (95.20 to 100) | February 13, 2023 | |||||