Table 8.
MMACA assay validation performance statistics.
| Parameter | Acceptance Criteria | Performance |
||||
|---|---|---|---|---|---|---|
| Act | Fha | Fim2/3 | Prn | Pt | ||
|
| ||||||
| Accuracy | Median %Error ≤25% | 23.84% | 10.97% | 5.97% | 19.76% | 1.93% |
| Goodness of Fit | Mean r2 | 0.9990 | 0.9989 | 0.9994 | 0.9996 | 0.9991 |
| Intra-operator Precision | Median %CV ≤40% | 18.10%–27.07% | 9.49%–22.96% | 9.16%–22.47% | 11.59%–15.92% | 12.63%–20.24% |
| Inter-operator (Intermediate) Precision | Median %CV ≤40% | 22.77% | 16.76% | 17.07% | 19.68% | 16.03% |
| Dilutional Linearity: | ||||||
| r2 | ≥0.9 | 0.91 | 0.99 | 0.99 | 0.98 | 0.97 |
| Slope | 0.9 to 1.1 | 0.93 | 1.00 | 1.02 | 0.98 | 1.01 |
| Intercept | −4.0 to 4.0 | −0.035 | 0.046 | −0.009 | 0.108 | −0.017 |
| Lower Limit of Quantification (LLOQ) | Median %Error ≤40% and %CV ≤40% | 0.09 AU/mL | 0.15 IU/mL | 0.06 AU/mL | 0.04 IU/mL | 0.08 IU/mL |
Act – Adenylate cyclase; Fha – filamentous hemagglutinin; Fim2/3 - Fimbria; Prn – Pertactin; Pt – Pertussis toxin antigens.