Table 1.
Results of acceptance criteria for the capture ELISA immunoglobulin assaysa
| Acceptance criteria | IgG | IgM | IgE |
|---|---|---|---|
| Linearity (r2) | 0.993 | 0.999 | 0.999 |
| Precision | |||
| System (%CV) | 5 | 2 | 6 |
| Method (%CV) | 17, 21, 23 | 4, 5, 11, 6, 7 | 17, 16, 4 |
| Accuracy (%O/E) | 140, 120 | 100, 102 | 136, 123 |
| Specificity | |||
| Immunological | Curves parallel | Curves parallel | Curves parallel |
| Biological | Acceptable | Acceptable | Acceptable |
| Detection limit (ng/ml) | 5 | 7 | 39 |
| Range (ng/ml) | 5–86 | 27–219 | 39–265 |
a
CV, Coefficient of variation; O/E, observed/experimental.