一种全自动血凝仪在人凝血因子Ⅷ浓缩剂效价检测中的应用

目的对STAGO全自动血凝仪检测人凝血因子Ⅷ浓缩剂(FⅧ)效价进行检测方法(一期法)确认。方法使用不同稀释液(样品稀释液(来自2015版中国药典)、Owren-Koller稀释液(来自法国DIAGNOSTICA STAGO公司))检测FⅧ效价,比较二者结果的差异。根据2015版中国药典要求进行检测方法确认,包括准确度、线性和范围、精密度及选择性。结果在(0.125-1)IU/mL范围内,人凝血因子Ⅷ国家标准品(GB)和FⅧ的效价LOG(IU/mL)]和凝固时间LOG(S)]均呈线性,相关系数均>0.990,各浓度回算值的回收率为96%-104%;准确度确认中GB回收率100%,各测定值CV≤5.4%;批内和批间精密度结果均CV<10.0%;选择性确认中GB回收率96%,且各效价结果均CV≤5.9%。2种稀释液检测效价结果差值在5%以内。结论 STAGO全自动血凝仪可满足FⅧ效价检测要求;2种稀释液对检测结果无明显差异。

Application of STAGO Compact analyzer in potency assay of human coagulation factor Ⅷ

Objective To assess the one-stage method in potency assay of factor Ⅷ coagulant activity(FⅧ∶C) determinationsby STAGO Compact analyzer.Methods We compared the FⅧ∶C potencies obtained using two kinds of dilutions from either Chinese Pharmacopoeia(2015 edition) or Owren-Koller.The accuracy, linearity and range, precision and selectivity of assay methodologies were evaluated according to the requirements of Chinese Pharmacopoeia(2015 edition).Results Linearity and range: the potency(LOG(IU/mL)) and coagulation time(LOG(S)) of Human coagulation FⅧ reference(GB) and FⅧ were all linearwithin the range of(1-0.125)IU/mL.The correlation coefficients were more than 0.990, and the recovery rates of all the potency assay results were in the range of 96%-104%. Accuracy: the recovery rate of GB was 100% with CVs no more 5.4%. Precision: the CVs in intra-and inter-lots were less than 10%. Selectivity: the recovery rate of GB was 96% and all CVs were no more than 5.9%. The differences of potency assay results with two dilutions were less than 5%.Conclusion STAGO analyzer can meet the requirement of FⅧ potency assay. There was no obvious difference between the potency estimates obtained with two dilutions.