STAGO全自动血凝仪在人凝血因子活性测定上的应用  

Application of full-automatic STAGO coagulation analyzer in determination of human coagulation factor activity

作　　者：刘朝阳[1] 方曼莉 徐樱妹[1] 郁佳俊[1] 马雷钧[1] 程鹏飞[1] 

机构地区：[1]上海生物制品研究所有限责任公司质量检定室,上海200052

出　　处：《中国生物制品学杂志》2015年第12期1305-1310,共6页Chinese Journal of Biologicals

摘　　要：目的探讨STAGO全自动血凝仪在人凝血因子活性测定上的应用。方法对STAGO全自动血凝仪按照GMP要求进行安装确认(installation qualification,IQ):实施信息核查并记录;运行确认(operational qualification,OQ):准确度、精密度(批内精密度及批间精密度)、干扰试验及参考范围的验证确认;性能确认(performance qualification,PQ):按STAGO凝血分析仪相关SOP检测6份人凝血因子Ⅷ样品活性,并计算6份样品检测值间的相对标准偏差(relative standard deviation,RSD)。结果已核实STAGO全自动血凝仪基本信息,安装环境及安装过程均符合要求,并已进行记录。厂家提供的正常及病理值质控血清测定3次的均值均在厂家提供的质控范围内;批内及批间精密性的变异系数(coefficient of variation,CV)均<10%;随机组与对照组相比平均偏差<10%;20份体检样本的均值、标准偏差(standard deviation,SD)及结果在正常参考范围的例数与总标本数的比例(R值)>0.9。6份人凝血因子Ⅷ样品检测值的RSD值为1.95%。结论经全面的设备确认,STAGO全自动血凝仪符合人凝血因子活性测定的要求。Objective To investigate the application of full-automatic STAGO coagulation analyzer in determination of human coagulation factor activity. Methods The installation qualification（IQ）, operational qualification（OQ） and performance qualification（PQ） of full-automatic STAGO coagulation analyzer were carried out according to the requirements in GMP, while the accuracy, precision（in intra- and inter-assays）, interference test and reference range were verified. Six samples of human coagulation factor Ⅷ（FⅧ）were determined for activity by using the STAGO coagulation analyzer according to the SOP, of which the relative standard deviation（RSD） was calculated. Results The basic information as well as installation environment and procedure met the GMP requirements and were recorded. The mean measured values in three tests of normal and pathological control sera provided by the manufacturers were within the scope of quality control provided. Both the coefficients of variation in intra- and inter-assays were less than 10%. The deviation of interference test results in random and control groups were less than 10%. The proportion of samples with mean, SD and result within the normal range to those of total samples（R value） was more than 0. 9. The RSD of test results of six samples of human F Ⅷ was 1. 95%. Conclusion Comprehensive device confirmation confirmed that STAGO coagulation analyzer met the requirements for determination of human coagulation factor activity.

关 键 词：STAGO全自动血凝仪 人凝血因子 设备验证 

分 类 号：R448[医药卫生—诊断学]