|
293宿主蛋白残留检测试剂盒 |
性能指标 |
结果 |
|
|
1.线性范围 |
定量范围 |
10.2~1000 ng/mL |
PASS |
|
四参数拟合R2 |
>0.99 |
PASS |
|
|
2.准确性 |
企业参考品偏差 |
RSD≤20% |
PASS |
|
3.回收率 |
模拟样本回收率 |
70%~130% |
PASS |
|
4精密度 |
批内差 |
CV≤20%（定量上下限≤25%） |
PASS |
|
批间差 |
CV≤25% |
PASS |
|
|
5.特异性 |
1μg/mL CHO，E.coli，VeroHCP检测值低于检测下限 |
PASS |
|
|
6.干扰性 |
1 mg/mL HSA 与5 mg/mL HAS均无干扰 |
PASS |
|
|
7.定量上限 |
10.2 ng/mL |
PASS |
|
|
8.定量下限 |
1000 ng/mL |
PASS |
|
|
9.耐用性 |
仪器适用性 |
MD SpectraMax i3x/BioTek ELx800/ Thermo Fish Multiskan TM SkyHigh |
PASS |
|
10.稳定性 |
有效期 |
2~8℃保存12月 |
PASS |
