Table 2.
Sensitivity, specificity, and reproducibility of the assay
| Assay | Sensitivity | Specificity | ĸ (95% CI) | Comments |
|---|---|---|---|---|
| Autoantibodies (one or more) | 83 | 92 | 0.70 (0.58–0.82) | Combination of three or more autoantibodies increases the risk |
| Anti-GAD65 | 68 | 98 | ||
| Anti-ICA512 | 58 | 99 | ||
| Anti-ICA | 59 | 94 | ||
| Cellular immunoblot | 74 | 88 | 0.63 (0.41–0.86) | Requires fresh cells, large volumes, and multiple antigens, not biased by HLA; 18 antigenic blots |
| T-cell proliferation | 60 | 69 | 0.52 (0.30–0.73) | Up to 20 antigens tested; requires fresh cells; antigens can be grouped |
| Class II tetramer | 46 | 72 | 0.41 (0.15–0.68) | HLA restriction; can be performed on frozen cells; specificity useful for perspective study |
| U.K.-ELISPOT | 61 | 69 | 0.08 (−0.20–0.36) | Optimally performed on frozen cells; HLA restricted; eight antigens tested |
Abbreviations: CI, confidence interval; HLA, human leukocyte antigen; ELISPOT, enzyme-linked immunosorbent spot.