EVALUATION OF Enzyme Immunoassays
Last updated: 1 June 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 | Platelia SARS-CoV-2 Total Ab | Bio-Rad Laboratories | 100% (86.28 to 100) | 84% (63.92 to 95.46) | 92% (73.97 to 99.02) | 92% (83.40 to 97.01) | 100% (95.20 to 100) | 100% (86.28 to 100) | 84% (63.92 to 95.46) | 92% (73.97 to 99.02) | 92% (83.40 to 97.01) | 100% (95.20 to 100) | 92% (83.40 to 97.01) | 100% (95.20 to 100) | November 19, 2020 |
| 2 | COVID-19 IgM/IgG Confirmation | Dia.Pro Diagnostic Bioprobes S.R.L | 96% (79.65 to 99.90) | 84% (63.92 to 95.46) | 92% (73.97 to 99.02) | 90.67% (81.71 to 96.16) | 100% (95.20 to 100) | 84% (63.92 to 95.46) | 91.67% (73 to 98.97) | 96% (79.65 to 99.90) | 90.54% (81.48 to 96.11) | 100% (95.07 to 100) | 90.60% (97.54 to 100) | 100% (97.54 to 100) | March 3, 2021 |
| 3 | GA CoV-2 IgG, IgM, IgG+ | GA Generic Assays Gmbh | 72.00% (50.61 to 87.93) | 64.00% (42.52 to 82.03) | 52.00% (31.31 to 72.20) | 62.67% (50.73 to 73.57) | 100% (95.20 to 100) | 96.00% (79.65 to 99.90) | 100.00% (86.28 to 100.00) | 100.00% (86.28 to 100.00) | 98.67% (92.79 to 99.97) | 85.14% (74.96 to 92.34) | 80.67% (73.43 to 86.65) | 92.62% (87.17 to 96.26) | |
| 4 | SARS-CoV-2 IgG Screen | Imbian Lab Llc. | N/A | N/A | N/A | N/A | N/A | 52.00% (31.31 to 72.20) | 64.00% (42.52 to 82.03) | 92% (73.97 to 99.02) | 69.33% (57.62 to 79.47) | 98.67% (92.79 to 99.97) | 69.33% (57.62 to 79.47) | 98.67% (92.79 to 99.73) | |