Table 1 Overview of the assay performance of anti-SmD1 and anti-SmD3 ELISAs determined in independent studies
Disease/control group | SmD1 ELISA | SmD3 ELISA | ||||||
|---|---|---|---|---|---|---|---|---|
| Â | Previous studies | Present study | Â | Present study, panel I | ||||
| Â | Riemekasten and colleagues, 1998 [15] | Jaekel and colleagues, 2001 [20] | Panel I (25 units) | Panel I (100 units) | Panel III (25 units) | Panel III (100 units) | Mahler and colleagues, 2005 [14] | Â |
Systemic lupus erythematosus (n) | 167 | 111 | 48 | 48 | 100 | 100 | 176 | 48 |
Controls (n) | 372 | 144 | 99 | 99 | 100 | 100 | 449 | 99 |
Primary Sjögren syndrome (n) | 15 | 10 | - | - | 7 | 7 | 24 | - |
Mixed connective tissue disease (n) | 23 | 13 | 16 | 16 | 7 | 7 | 26 | 16 |
Rheumatoid arthritis (n) | 28 | 10 | 50 | 50 | 22 | 22 | 86 | 50 |
Miscellaneous (n) | 73 | 21 | 15 | 15 | 5 | 5 | 21 | 15 |
Undifferentiated connective tissue disease (n) | - | 22 | - | - | - | - | - | - |
Scleroderma (n) | 20 | 11 | 17 | 17 | 18 | 18 | 26 | 17 |
Normal human donor (n) | 105 | 50 | - | - | 20 | 20 | 192 | - |
Polymyositis scleroderma overlap syndrome (n) | - | 7 | 11 | 11 | 6 | 6 | - | 11 |
Human immunodeficiency virus (n) | 88 | - | - | - | 5 | 5 | - | - |
Hepatitis B virus (n) | 20 | - | - | - | 5 | 5 | - | - |
Hepatitis C virus (n) | - | - | - | - | 5 | 5 | 30 | - |
Cytomagalovirus (n) | - | - | - | - | - | - | 22 | - |
Epstein–Barr virus (n) | - | - | - | - | - | - | 25 | - |
Sensitivity (%) | 70 | 36 | 45.8 | 12.5 | 47 | 21 | 15.9 | 12.5 |
Specificity (%) | 91.7 | 97.2 | 77.8 | 100 | 84 | 100 | 99.8 | 100 |