Table 2. Results for all LFIAs analysed.
| Sensitivity |
Specificity |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Sera (vs positives on S-ELISA and/or hybrid DABA) |
Finger-prick self-test (vs positives on S-ELISA and/or hybrid DABA) |
Police force sera Nov 2019 (all positives considered false) |
|||||||||
| Lateral flow assay | Sensitivity | 95% CI | n/N | Sensitivity | 95% CI | n/N | Specificity | 95% CI | n= | Invalidity (n) | |
| Phase 1 | W0NDF0(lgM/lgG combined) | 80% | 70.2 to 87.4 | 75/94 | 22% | 13.1 to 33.1 | 16/73 | 99.4% | 98.3 to 99.9 | 497/500 | 0% (0) |
| MENARINI (separate IgM and IgG) | 93% | (86.3 to 96.5 | 112/121 | 96% | 84.9 to 99.5 | 43/45 | 97.8% | 96.1 to 98.9 | 489/500 | 0.6% (3) | |
| FORTRESS (separate IgM and IgG) | 88% | 83.3 to 91.2 | 255/291 | 84% | 70.5 to 93.5 | 38/45 | 98.6% | 97.1 to 99.4 | 493/500 | 0.6% (3) | |
| BIOPANDA 1 (separate IgM and IgG) | 65% | 56.7 to 72.2 | 101/156 | 67% | 55.5 to 76.6 | 56/84 | 99.8% | 98.9to 100.0 | 499/500 | 0% (0) | |
| BIOSURE/MOLOGIC 1 (IgG only) | 71% | 62.2 to 77.9 | 98/139 | 61% | 46.2 to 74.8 | 30/49 | 97.2% | 95.3 to 98.5 | 486/500 | 1.6% (8) | |
|
| |||||||||||
| Phase II | SURE-BIOTECH (separate IgM and IgG) | 68% | 57.3 to 77.1 | 63/93 | |||||||
| BIOSURE/MOLOGIC II (IgG only)* | 48% | 40.8 to 55.9 | 87/180 | ||||||||
| BIOPANDA II (separate IgM and IgG) | 82% | 75.7 to 86.4 | 151/184 | 98.4% | 96.5 to 99.2 | 442/450 | 0% (0) | ||||
| BIOMERICA (separate IgM and IgG) | 81% | 74.7 to 86.4 | 149/184 | 97.8% | 96.1 to 98.9 | 489/500 | 0% (0) | ||||
| SURESCREEN (separate IgM and IgG) | 88% | 81.8 to 91.9 | 161/184 | 99.8% | 98.9 to 100 | 499/500 | 0% (0) | ||||
| ABBOTT (separate IgM and IgG) | 91% | 85.6 to 94.5 | 167/184 | 99.8% | 98.9 to 100 | 499/500 | 0% (0) | ||||
|
| |||||||||||
| Reference assays | Laboratory test | vs PCR-confirmed cases | |||||||||
| S-ELISA | 94.5% | 91.4 to 96.8 | 293/310 | ||||||||
| RBD hybrid DABA | 94.8% | 91.6 to 97.1 | 274/289 | ||||||||
| Composite ELISA/hybrid DABA positivity | 95.2% | 92.2 to 97.3 | 296/311 | ||||||||
Biosure/Mologic II was tested with 5 μι serum in phase II (in accordance with instructions provided at time). Manufacturer advises test should be performed with 10 μι serum. DABA, Double antigen bridging assay; IgG, immunoglobulin G; IgM, immunoglobulin M; RBD, Receptor binding domain; S-ELISA, spike protein ELISA.