Table 2. Validation Results of Accuracy and Precision for CP-III Concentrations in Human Plasmaa.
| nominal CP-III concentrations (ng/mL) | ||||||
|---|---|---|---|---|---|---|
| endogenous | LLOQ sample | low QC sample | mid QC sample | high QC sample | ||
| 0.01 + endo | 0.03 + endo | 15 + endo | 40 + endo | |||
| within-run | ||||||
| 1 | mean (ng/mL) | 0.0355 | 0.0438 | 0.0606 | 14.2 | 35.9 |
| accuracy (%) | 96.3 [81.3–103.3] | 92.5 [87.0–97.7] | 94.5 [89.5–101.0] | 90.0 [87.6–92.8] | ||
| precision (%CV) | 14.8 | 8.05 | 3.99 | 4.44 | 2.06 | |
| 2 | mean (ng/mL) | 0.0422 | 0.0527 | 0.0678 | 13.7 | 37.1 |
| accuracy (%) | 101.0 [88.2–116.9] | 94.0 [85.9–103.9] | 91.3 [89.5–94.8] | 92.7 [87.4–98.9] | ||
| precision (%CV) | 9.43 | 9.22 | 6.22 | 1.90 | 4.32 | |
| 3 | mean (ng/mL) | 0.0500 | 0.0522 | 0.0695 | 14.6 | 38.4 |
| accuracy (%) | 89.3 [81.7–91.7] | 106.8 [87.5–96.3] | 96.9 [90.0–107.0] | 95.8 [86.5–108.4] | ||
| precision (%CV) | 8.08 | 3.90 | 4.03 | 6.69 | 8.57 | |
| run-to-run | ||||||
| accuracy (%) | 95.5 | 92.1 | 94.2 | 92.9 | ||
| precision (%CV) | 17.4 | 11.0 | 8.21 | 5.49 | 6.64 | |
a
CP-III, coproporphyrin-III; LLOQ, lower limit of quantitation; QC, quality control; Endo, endogenous level; CV, coefficient of variation.