Summary of performance of COVID-19 serological assays following laboratory evaluation by PHE15
| Company (total number of samples used for PHE validation) | Roche Elecsys Anti-SARS-CoV-2 (93 convalescent, 472 negative samples) | Ortho Clinical Diagnostics VITROS Immunodiagnostic (93 convalescent, 490 negative samples) | Ortho Clinical Diagnostics VITROS Immunodiagnostic (100 convalescent, 491 negative samples) | Beckman Coulter Access (100 convalescent, 499 negative samples) | Siemens Atellica-IM (100 convalescent, 499 negative serum samples) |
| Assay target (type of assay) | Total antibody (electrochemiluminescent) | IgG (chemiluminescent) | Total serology (chemiluminescent) | IgG (chemiluminescent) | Total antibody (chemiluminescent) |
| Specificity (manufacturer) | 99.8 (99.7 to 99.9) | 100 (99.1 to 100.0) | 100 (99.1 to 100.0) | 99.8 (99.4 to 99.9) | 99.82 (91.59 to 99.98) |
| Sensitivity (manufacturer) | 100 (88.1 to 100.0) (samples taken ≥14 post-PCR confirmation) | 90.0 (76.3 to 97.2) (samples taken >15 days after symptom onset) | 100 (92.7 to 100.0) (samples taken >8 days after symptom onset) | 100 (93.8 to 100.0) (samples taken >18 days from positive PCR test) | 100 (91.59 to 100.0) (samples taken ≥14 post PCR confirmation) |
| Specificity (PHE) | 100 (99.1 to 100.0) | 99.7 (98.6 to 100.0) | 99.5 (98.2 to 99.9) | 99.3 (97.8 to 99.8) | 100 (99.1 to 100.0) |
| Sensitivity ≥14 days after symptom onset (PHE) | 86.1 (76.5 to 92.8) | 79.7 (69.2 to 88.0) | 91.8 (83.3 to 96.6) | 76.5 (66.0 to 85.0) | 89.4 (80.8 to 95.0) |
| Sensitivity of the assay at ≥21 days after symptom onset (PHE) | 86.7 (76.8 to 93.4) | 81.3 (70.7 to 89.4) | 93.5 (85.5 to 97.9) | 79.2 (93.8 to 100.0) | 92.4 (84.2 to 97.2) |
| Company (total number of samples used for PHE validation) | Euroimmun Medizinische Labordiagnostika AG (93 convalescent,499 negative samples) | Abbott (96 convalescent, 760 negative samples) | DiaSorin LIAISON (100 serum, 472 negative samples) | ||
| Assay target (type of assay) | IgG (ELISA) | IgG (chemiluminescent) | S1/S2 IgG (chemiluminescent) | ||
| Specificity (manufacturer) | 99.6 (No CI) | 99.6 (99.1 to 99.9) | 98.5 (97.6 to 99.1) | ||
| Sensitivity (manufacturer) | 94.4 (no CI) (≥10 days after symptom onset) | 100 (95.9 to 100.0) (≥14 days after symptom onset) | 97.4 (86.8 to 99.5) | ||
| Specificity (PHE) | 99.0 (97.5 to 99.7) | 100 (99.1 to 100.0) | 97.7 (95.8 to 99.0) | ||
| Sensitivity of ≥14 days after symptom onset (PHE) | 73.4 (62.3 to 82.7) | 93.9 (86.3 to 98.0) | 69.4 (58.5 to 79.0) | ||
| Sensitivity of the assay at ≥21 days after symptom onset (PHE) | 74.7 (63.3 to 84.0) | 93.5 (85.5 to 97.9) | 71.4 (60.0 to 81.2) | ||
Sensitivity and specificity are presented as percentages and confidence intervals in brackets.
CI, confidence intervals; PHE, Public Health England; S, spike protein.