Table 11.
Summary of validation.
| No. | Validation items | Results | ||||
|---|---|---|---|---|---|---|
| 1 | Cut point (screen, confirmation, titer) | SCP: 1.08 | ||||
| CCP: 12.65 | ||||||
| TCP: 1.17 | ||||||
| 2 | Sensitivity, LPC, titer | Sensitivity: 33.0 ng/mL | ||||
| LPC: 41.0 ng/mL | ||||||
| HPC titer acceptance range: 320–1280 | ||||||
| 3 | Establish system suitability control acceptance criteria | |||||
| 4 | Precision | Samples | Mean | STD | RSD% | |
| Intra-plate SNR | HPC | 10.84 | 1.91 | 17.62 | ||
| LPC | 1.53 | 0.15 | 9.80 | |||
| NC | 1.00 | 0.02 | 2.00 | |||
| Inter-plates SNR | HPC | 8.83 | 1.19 | 13.48 | ||
| LPC | 1.58 | 0.17 | 10.76 | |||
| NC | 1.00 | 0.03 | 3.00 | |||
| 5 | Drug tolerance | HPC level: up to 768.0 μg/mL 100.0 ng/mL HLX26 ADA level: up to 291.0 μg/mL |
||||
| 6 | Target interference | HPC & LPC: no false negative detected NC: 74.0 ng/mL (a false positive is detected if LAG-3 > 74.0 ng/mL) |
||||
| 7 | Matrix effect | |||||
| Selectivity | Pass | |||||
| Hemolysis | Pass | |||||
| Lipemia | Pass | |||||
| 8 | Hook effect | Pass | ||||
| 9 | Assay robustness | Pass | ||||
| 10 | Stability | |||||
| Room temperature | Pass (up to 24 h) | |||||
| 2–8 °C | Pass (up to 7 d) | |||||
| Freeze-thaw | Pass (up to 6 cycles) | |||||