Table 1.
Accuracy and precision data for neurounina-1 from the pre-study validation in beagle dog plasma.
| Nominal value | 1 ng/mL |
1.5 ng/mL |
30 ng/mL |
240 ng/mL |
400 ng/mL |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Batch identification | Val. 1 | Val. 2 | Val. 3 | Val. 1 | Val. 2 | Val. 3 | Val. 1 | Val. 2 | Val. 3 | Val. 1 | Val. 2 | Val. 3 | Val. 1 | Val. 2 | Val. 3 |
| Individual concentration values | 1.3 | 1.05 | 1.26 | 1.75 | 1.66 | 1.74 | 30.75 | 29.02 | 29.03 | 225.83 | 230.3 | 224.19 | 390.3 | 401.4 | 384.91 |
| 1.13 | 1.01 | 0.88 | 1.52 | 1.72 | 1.46 | 30.78 | 29.01 | 28.68 | 228.15 | 237.39 | 227.31 | 393.52 | 400.99 | 383.35 | |
| 1.15 | 0.86 | 1.17 | 1.41 | 1.64 | 1.66 | 30.41 | 29.08 | 30.16 | 224.93 | 230.01 | 231.55 | 399.52 | 386.85 | 376.37 | |
| 1.21 | 1.04 | 0.81 | 1.52 | 1.28 | 1.55 | 29.84 | 30.96 | 29.35 | 228.29 | 229.99 | 225.94 | 386.95 | 392.3 | 382.44 | |
| 1.19 | 1.1 | 1.08 | 1.32 | 1.68 | 1.59 | 29.13 | 31.31 | 29.74 | 229 | 232.18 | 230.03 | 404.31 | 404.53 | 377.86 | |
| 1.22 | 1.11 | 1.09 | 1.71 | 1.8 | 1.6 | 28.71 | 28.45 | 29.71 | 234.66 | 232.4 | 226.96 | 392.94 | 389.26 | 374.23 | |
| 0.98 | 1.05 | 0.88 | 1.65 | 1.48 | 1.68 | 28.81 | 29.49 | 27.89 | 226.92 | 226.12 | 228.19 | 387.97 | 397.01 | 375.87 | |
| Mean (ng/mL) | 1.17 | 1.03 | 1.02 | 1.55 | 1.61 | 1.61 | 29.8 | 29.6 | 29.2 | 228 | 231 | 228 | 394 | 396 | 379 |
| Intra-run precision (CV%) | 8.5 | 8.1 | 16.5 | 10.2 | 10.8 | 5.7 | 3.0 | 3.7 | 2.6 | 1.4 | 1.5 | 1.1 | 1.6 | 1.7 | 1.1 |
| Intra-run accuracy (%) | 116.9 | 103.1 | 102.4 | 103.6 | 107.2 | 107.4 | 99.3 | 98.7 | 97.4 | 95.1 | 96.3 | 94.9 | 98.4 | 99.0 | 94.8 |
| Inter-run mean (ng/mL) | 1.075 | 1.59 | 29.54 | 229.1 | 389.7 | ||||||||||
| Inter-run precision (CV%) | 12.6 | 8.9 | 3.1 | 1.4 | 2.4 | ||||||||||
| Inter-run accuracy (%) | 107.5 | 106.1 | 98.5 | 95.4 | 97.4 | ||||||||||
Val, validation; CV% = [(SD/M) × 100]; Accuracy % = [(E - T)/T] × 100; CV, coefficient of variation; M, mean; SD, standard deviation of M; E, experimentally determined concentration; T, theoretical concentration.