Validation result summary | ||||
---|---|---|---|---|
Test Parameter | Acceptance Criteria | Result | ||
Accuracy | Recovery 90–110% ([18F]FET spiked with [18F]fluoride) | [18F]fluoride concentration | Recovery | |
1% | 105.0% | |||
3% | 104.6% | |||
5% | 105.9% | |||
Repeatability | 6 repetitions (5% [18F]fluoride) | RSD ≤5% | RSD = 1.96% | |
Intermediate Precision | RSD ≤5% (3 analysts) | RSD = 2.90% | ||
Specificity | Resolution of > 2 between peaks | Resolution of[18F]fluoride and [18F]FET | Rs = 5.7 | |
Limit of Quantification | S/N ratio ≥ 10 | 24 kBq/ml | ||
Linearity | 12–1232 kBq/ml (5 concentrations in triplicate) | R > 0.99 | R = 0.995 | |
Range | Reported value | 4.8–1232 MBq/ml |