9. Sensitivity and specificity by test brand (IgM).
| Test namea | Test method |
IgM sensitivity by time since onset of symptoms Studies (true positives/COVID‐19 cases) Sensitiivity (95% CI) |
IgM specificity Studies (false positives/COVID‐19 cases) Specificity (95% CI) |
||||
| 1‐7 days | 8‐14 days | 15‐21 days | 22‐35 days | > 35 days | |||
| Artron Laboratories IgM/IgG | CGIA | 1 (5/7) | 1 (12/15) | 1 (8/8) | |||
| 71.4% (29.0 to 96.3) | 80.0% (51.9 to 95.7) | 100% (63.1 to 100) | |||||
| Autobio Diagnostics IgM/IgG | CGIA | 1 (6/7) | 1 (14/15) | 1(8/8) | |||
| 85.7% (42.1 to 99.6) | 93.3% (68.1 to 99.8) | 100% (63.1 to 100) | |||||
| Beijing Hotgen | ELISA | 1 (10/22) | 1 (72/92) | 1 (72/92) | 1 (41/45) | 1 (0/100) | |
| 45.5% (24.4 to 67.8) | 78.3% (68.4 to 86.2) | 78.3% (68.4 to 86.2) | 91.1% (78.8 to 97.5) | 100% (96.4 to 100) | |||
| Beijing Hotgen | CGIA | 1 (22/72) | |||||
| 69.4% (57.5 to 79.8) | |||||||
| Beijing Wantai | ELISA | 1 (3/513) | |||||
| 99.4% (98.3 to 99.9) | |||||||
| Beijing Wantai | CGIA | 1 (4/209) | |||||
| 98.1% (95.2 to 99.5) | |||||||
| Bioscience Co (Chongqing) | CLIA | 1 (34/67) | 1 (34/67) | 1 (131/134) | 1 (13/13) | ||
| 50.7% (38.2 to 63.2) | 50.7% (38.2 to 63.2) | 97.8% (93.6 to 99.5) | 100% (75.3 to 100) | ||||
| CTK Biotech OnSite IgG/IgM | CGIA | 1 (5/7) | 1 (14/15) | 1 (8/8) | |||
| 71.4% (29.0 to 96.3) | 93.3% (68.1 to 99.8) | 100% (63.1 to 100) | |||||
| Darui Biotech | ELISA | 1 (14/64) | |||||
| 78.1% (66.0 to 87.5) | |||||||
| Dynamiker Biotechnology IgG/IgM | CGIA | 1 (5/7) | 1 (14/15) | 1 (8/8) | |||
| 71.4% (29.0 to 96.3) | 93.3% (68.1 to 99.8) | 100% (63.1 to 100) | |||||
| EUROIMMUN | ELISA | 1 (76/82) | |||||
| 92.7% (84.8 to 97.3) | |||||||
| EUROIMMUN Anti‐SARS‐Cov | IIFT | 1 (1/10) | |||||
| 90.0% (55.5 to 99.7) | |||||||
| Hangzhou Alltest ‐ IgG/IgM | CGIA | 1 (1/8) | 2 (23/42) | 2 (58/68) | 2 (0/45) | ||
| 12.5% (0.3 to 52.7) | 54.8% (38.7 to 70.2) | 85.3% (74.6 to 92.7) | 100% (92.1 to 100) | ||||
| Shenzhen YHLO | CLIA | 7 (10/321) | |||||
| 96.9% (94.3 to 98.5) | |||||||
| Vivachek ‐ VivaDiag IgM/IgG | CGIA | 2 (1/42) | |||||
| 97.6% (87.4 to 99.9) | |||||||
| Xiamen InnodDx Biotech | CLIA | 1 (2/300) | |||||
| 99.3% (97.6 to 99.9) | |||||||
| Zhuhai Livzon | CGIA | 1 (7/36) | 1 (31/34) | 1 (35/38) | 2 (0/35) | ||
| 19.4% (8.2 to 36.0) | 91.2% (76.3 to 98.1) | 92.1% (78.6 to 98.3) | 100% ( 90.0 to 100) | ||||
| Zhuhai Livzon | ELISA | 3 (14/66) | 2 (150/202) | 2 (159/166) | 1 (43/45) | 5 (3/351) | |
| 21.2% (12.1 to 33.0) | 74.3% (67.7 to 80.1) | 95.8% (91.5 to 98.3) | 95.6% (84.9 to 99.5) | 99.1% (97.5 to 99.8) | |||
| CGIA: colloidal gold immunoassay; CI: confidence interval; CLIA: chemiluminescence immunoassay; ELISA: enzyme‐linked immunosorbent assay; FIA: fluorescence immunoassay; IIFT: indirect immunofluorescence assay; LFA: lateral flow assay | |||||||
aSee Appendix 12 for details of manufacturer product codes, where available.