|
| 质量标准 | 批号 | 稳定性实验 | ||
|
| 120618 | 120628 | 120708 | 批号120708 | |
| 准确性 | ±10% | 103.5 | 99.7 | 101.1 | 105.3 |
| 线性 | r ≥ 0.9900 | 0.9997 | 0.9999 | 0.9998 | 0.9999 |
| 敏感性 | ≤1.0 U/mL | 0.1 | 0.1 | 0.1 | 0.1 |
| 质控血清 | L: 24～36 U/mL | 32.1 | 32.0 | 30.6 | 32.8 |
|
| H: 400～600 U/mL | 503.4 | 500.0 | 494.2 | 532.4 |
| 重复性 | 批内CV ≤ 15.0% | 2.8 | 3.6 | 3.0 | 3.7 |
|
| 批间CV ≤ 15.0% | 三批试剂的批间CV值3.4% | / | ||