中文摘要：

目的利用新鲜冰冻血浆制备抗凝血酶、蛋白C、蛋白S活性检测质控物,评价其均匀性和稳定性,并试用于室内质控。方法依据ISO Guide35及CNAS-GL03的要求,对2个批次自制质控物的均匀性和稳定性进行评价。将质控物试应用于室内质控,同时检测商品质控物作为对照。结果均匀性评价结果显示质控物样品间均匀性良好,差异无统计学意义（P〉0.05）,AT、PC和PS的瓶间均匀性不确定度ubb的分布范围分别为0.30%～2.39%,0.16%～2.45%和0.19%～3.62%;复融后在室温和冷藏条件下3种抗凝蛋白活性稳定时间分别为24h和24h、8h和12h、3h和12h。第1批次质控物长期稳定性评价结果显示正常和异常浓度水平的AT和PC质控物的稳定时间为24周,正常浓度的PS质控物稳定时间为19周,异常低浓度的PS质控物稳定时间为12周;3个项目的长期稳定性不确定度ults范围分别为2.45%～3.68%、1.32%～3.19%和3.97%～10.17%。室内质控试应用结果显示3个项目第1批次各批号质控物检测结果的CV均小于厂商规定的批间不精密度,与商品质控物具有可比性。结论质控物的均匀性、稳定性符合相关指南要求,可应用于室内质控。

英文摘要：

Objective To evaluate the homogeneity and stability of internal quality control materials for antithrombin,protein C,and protein S activity testing,with freshly frozen plasma,and to investigate the application of the preparation in internal quality control.Methods The homogeneity and stability of 2batches of quality control materials were evaluated according to ISO Guide 35 and CNAS-GL 03.They were also applied to internal quality control and compared with manufacturer′s quality control materials.Results Homogeneity evaluation showed that the samples had good uniformity,no significant differences were found（P〉0.05）.The uncertainty of homogeneity between bottles of AT,PC and PS quality control materials ranges from 0.30% ～2.39%,0.16% ～2.45% and 0.19% ～3.62%,respectively.The stable times of three kinds of anticoagulant proteins activity materials after thawing at room temperature and refrigeration were as follows：24h and 24 h,8hand 12 h,3hand 12 h.Long-term stability evaluation showed that the stabilization time of the first batch of quality control materials under-80℃ were as follows：24wks for normal and abnormal levels of AT and PC,19 wks for normal level of PS,and 12 wks for abnormal low levels of PS.The long-term stability uncertainty ranges of AT,PC and PS were 2.45%～3.68%,1.32% ～3.19% and 3.97% ～10.17%,respectively.The internal quality control results showed that the imprecision of three lots of the first batch quality control materials test results were lower than the extra-assay imprecision prescribed by the manufacturer,and they were comparable with commercial quality control materials.Conclusions The uniformity and stability of quality control materials for the anticoagulant proteins activity testing were acceptable in accordance with the relevant guidelines.They may be applied to internal quality control.