摘要目的 应用常规凝血项目质评数据(EQA)建立常规凝血项目目标测量不确定度(MU).方法 北京市临床检验中心(BCCL)采用"自上而下(up-down)"的方法,依据北京市93家医院临床实验室室间质量评价(EQA)数据,建立常规6项凝血项目,即活化部分凝血活酶时间(APTT)、纤维蛋白原(FBG)、国际标准化比值(INR)、凝血酶原时间(PT)、凝血酶时间(TT)和D二聚体(D-dimer)的目标测量不确定度.并与CLIA′88标准进行比较,以观察当前凝血项目的检测水平.结果 6项凝血项目各实验室仪器组测量不确定结果与CLIA′88标准比较显示:APTT项目的B仪器组;FBG项目的A、B、C仪器组;INR项目的B仪器组和D-dimer项目的B仪器组第90百分位数均符合标准.INR项目的A、C仪器组;PT项目的C仪器组第75百分位数符合标准.APTT项目的A、C仪器组;PT项目的A仪器组;INR项目的D仪器组中位数符合标准.结论 仅用EQA数据,建立了常规凝血项目目标测量不确定度.仅用EQA数据评定测量不确定度的方法,简化了实验室测量不确定度的评定过程;同时,可以根据EQA计划的频次,持续更新实验室测量不确定度的数据,具有良好的临床实用价值.但在该方法的使用中亦应充分考虑其适用性.

abstractsObjective To establish the target measurement uncertainty(MU)of the routine coagulation assay according to the External Quality Assessment data(EQA)of routine coagulation assay. Methods Beijing Center for Clinical Laboratory(BCCL)established the target measurementuncertainty for routine coagulation assayswith the"up-down"methodon the basis of 93 clinical laboratoriesEQA datain BeijingThese assays includedActivated partial thromboplastine time(APTT), Fibrinogen(FBG), International Normalized Ratio(INR), Prothrombin time(PT), Thrombin time(TT)and D-dimer, Compared with CLIA′88,the proficiency of current coagulation assayswas observed.Results The MU of six routine coagulation assayscompared with CLIA ′88 showed that: The 90th percentile MU met the creteriain APTTof group B,FBG of group A&B&C,INR of group B and D-dimer of group B.The 75th percentile MU met the creteriainINR of group A&C,PT of group C.The medium met the creteriainAPTT of group A&C,PT of group A and INR of group D.Conclusions Target Measurement Uncertainty was establishedin routine coagulation assay by using EQA data only,whichcan simplify the procedure of determining MU and continuously update MU according to the frequency of EQA.It has good clinical practical value.However, the applicability of this method should also be considered.