Table 2.
Summary of the specifications and results for the validation of the radio-HPLC method (RAD detection).
| Parameter | Criteria | Specifications | Results |
|---|---|---|---|
| Identity | RRT | 0.95–1.05 | Isomer 1:1.01 Isomer 2:1.006 |
| Linearity | R2 value | R2 ≥ 0.99 | 0.9975 |
| Specificity | R value | R > 1.5 | 1.99–4.76 |
| Repeatability (%) | RRT | CV ≤ 2 | < 1.8 |
| Accuracy (%) | Recovery | ≥ 95 | 95.6 ± 0.6 |
| LOQ (MBq/mL) | Radio detection | Signal/noise ratio > 10 | Isomer 2:8 68Ga3+:0.228 |
| LOD (MBq/mL) | Radio detection | Signal/noise ratio > 3 | Isomer 2:1.05 68Ga3+:0.097 |
| HR test | Radio detection | No extra signal | No extra signal |