试剂因子敏感性差异导致APTT室间质量评价失控分析  

Analysis of failures in EQA induced by intrinsic pathway factor responsiveness of APTT reagents

作　　者：王威[1] 袁莉[1] 何晓璇[1] 王刚[1] WANG Wei;YUAN Li;HE Xiaoxuan;WANG Gang(Department of Clinical Laboratory,the First Affiliated Hospital of Xi'an Jiaotong University,Xi'an 710061,Shaanxi,China)

机构地区：[1]西安交通大学第一附属医院检验科,陕西西安710061

出　　处：《检验医学》2018年第12期1136-1139,共4页Laboratory Medicine

摘　　要：目的通过分析活化部分凝血活酶时间(APTT)室间质量评价(EQA)失控原因,进一步探讨EQA方案存在的问题。方法分析EQA回报结果,逐步排查失控原因。参照CLSI H47-A2文件中APTT试剂因子敏感性评估方法,量化评估某国产试剂(鞣花酸法)与仪器原厂配套试剂(鞣花酸法)内源性凝血因子的敏感性。APTT试剂因子敏感性由非线性回归曲线与正常参考区间上限的交叉点确定,并用百分活度(%)表示。结果回报结果均为正偏移,失控标本均为低值标本。EQA当月实验室各项记录正常,人员操作合规,质评物正常。上报系统显示,凝血项目EQA按仪器分组,未按试剂/仪器检测系统分组。某国产试剂的因子敏感性为:FⅧ54.0%,FⅨ37.3%,FⅪ56.5%,FⅫ36.4%;原厂配套试剂的因子敏感性为:FⅧ42.9%,FⅨ30.0%,FⅪ45.3%,FⅫ28.4%。结论 EQA APTT项目失控是由所使用试剂的内源性凝血因子敏感性与原厂配套试剂不一致导致的。APTT项目的EQA不应仅按仪器分组,应按试剂/仪器检测系统分组,以避免对参评实验室的错误判断。Objective To investigate the failures of activated partial thromboplastin time(APTT)external quality assessment(EQA),and to analyze the problems in EQA.Methods The results of EQA and failures were analyzed step by step.According to the Clinical and Laboratory Standards Institute(CLSI)H47-A2guideline,the intrinsic pathway factor responsiveness of domestic reagent(ellagic acid)and original reagent(ellagic acid)was analyzed.The APTT responsiveness in percent activity(%)could be determined from the intersection of curve and the upper limit of APTT normal reference range.Results All of the results were positive bias,and the samples with failures were low-value samples.The laboratory documentations were normal in the EQA month.The experimental operators strictly followed the standards of operation.The EQA materials were normal.The reported data showed that EQA coagulation items were classified according to instruments,not according to reagents/instruments.The APTT responsiveness of domestic reagent was FⅧ54.0%,FⅨ37.3%,FⅪ56.5%and FⅫ36.4%.The APTT responsiveness of original reagent was FⅧ42.9%,FⅨ30.0%,FⅪ45.3%and FⅫ28.4%.Conclusions The failures of APTT EQA are caused by the difference of intrinsic pathway factor responsiveness between original and domestic reagents.The item of APTT should not only be grouped by instruments,but also be grouped by reagents/instruments to avoid false judgement for participating laboratories.

关 键 词：活化部分凝血活酶时间 室间质量评价 失控原因 因子敏感性 

分 类 号：R446.62[医药卫生—诊断学]