Table 2: Validation parameters and followed criteria.
Parameter | What/How | Criterion |
Sensitivity/Linearity | Linearity check from five levels | Deviation of back - calculated concentration from true concentration (x - Residulas) ≤ 20% |
LOQ | Lowest spike level meeting the method performance criteria for trueness and precision | - |
Specificity | Response in the blank samples | - |
Trueness | Average recovery for each spike level tested | 70-120% |
Precision (RSDr) | Repeatability for each spike level tested | ≤ 20% |
Precision (RSDwR) | Within - laboratory reproducibility, derived from on-going method validation/verification | ≤ 20% |
Robustness | Average recovery and RSDwR derived from on-going method validation/verification | See above |