Table 2. System suitability-Sensitive Assay: Excellent accuracy and linearity.
BoNT/A Dilutional linearity//Recovery Table for Sensitive Assay | ||||||
Concentration | Expected Relative Potency | Actual Relative Potency | Confidence Interval (CI) | Percent Recovery | Number of assays | Number of assay with CI overlapping 1 |
0.57× | 1.75 | 1.69 | 1.54–1.85 | 96.3 | 4 | 0 of 4 |
0.66× | 1.5 | 1.50 | 1.36–1.66 | 100 | 4 | 0 of 4 |
0.8× | 1.25 | 1.34 | 1.26–1.41 | 106.8 | 4 | 0 of 4 |
1.33× | 0.75 | 0.85 | 0.78–0.91 | 111.9 | 4 | 0 of 4 |
1.5× | 0.66 | 0.68 | 0.63–0.73 | 103.3 | 4 | 0 of 4 |
2.0× | 0.5 | 0.55 | 0.52–0.59 | 111.6 | 4 | 0 of 4 |