摘要
目的评定常规凝血项目测量不确定度,探讨利用室内质控(IQC)及能力验证数据评定测量不确定度方法的可行性。方法参照CNAS-TRL-001文件,收集2017年9月~2018年8月3个水平的IQC数据和2016~2018年卫生部临检中心组织的6次能力验证数据,采用“自上而下”的评定方法,评定凝血酶原时间(PT)、国际标准化比值(INR)、部分凝血活酶时间(APTT)、血浆纤维蛋白原浓度(FIB)的相对扩展不确定度。结果各项目的不确定度从水平1到水平3依次为:PT(11.02;11.91;13.10)、INR(13.94;14.67;16.26)、APPT(12.22;13.97;13.24)、FIB(16.17;15.76;15.48)。结论采用IQC及能力验证数据评定常规凝血项目的不确定度符合CLIA,88目标测量不确定度的要求,是一种简便易行的评定方法,具有良好的应用价值。
Objective To evaluate the measurement uncertainty of conventional coagulation items,and to explore the feasibility of evaluating measurement uncertainty using indoor quality control(IQC)and proficiency testing data.Methods With reference to the CNAS-TRL-001 document,collect three levels of IQC data from September 2017 to August 2018 and six capacity verification data organized by the Clinical Inspection Center of the Ministry of Health from 2016 to 2018.Evaluation method,to assess the relative extended uncertainty of prothrombin time(PT),international standardized ratio(INR),partial thromboplastin time(APTT),and plasma fibrinogen concentration(FIB).Results The uncertainty of each item from level 1 to level 3 is:PT(11.02;11.91;13.10),INR(13.94;14.67;16.26),APPT(12.22;13.97;13.24),FIB(16.17;15.76;15.48).Conclusion The IQC and proficiency testing data are used to evaluate the uncertainty of conventional coagulation items in line with the requirements of CLIA,88 target measurement uncertainty.It is a simple and easy evaluation method with good application value.
作者
刘振玲
LIU Zhen-ling(Department of Clinical Laboratory,Jizhou District People's Hospital,Tianjin 301900,China)
出处
《医学信息》
2020年第3期165-167,共3页
Journal of Medical Information
关键词
不确定度
凝血项目
能力验证数据
Uncertainty
Coagulation items
Proficiency testing data
