Table 1.
Validation results and acceptance criteria.
| Validation Parameter | Acceptance Criteria | Results | Conclusion |
|---|---|---|---|
| Calibration model | 80–120% recovery CV < 20% |
four-parameteric logistics (1/Y2) 99–101% recovery CV < 20% |
Complies |
| ULoQ | 80–120% recovery CV < 20% |
900 pg·mL−1
102% recovery CV 5.0% |
Complies |
| LLoQ | 80–120% recovery CV < 20% |
1.23 pg·mL−1
101% recovery CV 15.3% |
Complies |
| LoD (pg·mL−1) | zero calibrator +3× SD | 0.44 pg·mL−1 | |
| Intra-assay precision | mid-range: CV < 15% high-/low-range: CV < 20% |
CV 13.5% CV 12.9–15.3% |
Complies |
| Inter-assay precision | CV < 20% | CV 10.7–19.4% | Complies |
| Recovery | 80–120% recovery | 90–99% recovery | Complies |
| Dilutional linearity | 80–120% recovery | 82–117% recovery | Complies |
| Parallelism | 80–120% recovery | 91–115% recovery | Complies |
| Analyte stability | 80–120% recovery | 83–105% recovery | Complies |
CV: coefficient of variation; ULoQ: upper limit of quantification; LLoQ: lower limit of quantification.