检验医学与临床2017，Vol.14Issue(1)：1-2,6,3.DOI:10.3969/j.issn.1672-9455.2017.01.001
基于质控数据用Top-Down方法评定凝血检验项目测量不确定度
Evaluation of measurement uncertainty in coagulation detection items by Top-Down method based on quality control data
摘要
Abstract
Objective To explore the application of measurement uncertainty evaluation in clinical coagulation detection items by using the Top‐Down method combining with the quality control data .Methods The internal quality control(IQC) data of clinical laboratory department of our hospital in 6 consecutive months during 2015 and the return report results of ten times of external quality assessment(EQA) of the National Health and Family Planning Commission or Jiangsu Provincial Clinical Laboratory Center were collected .The measurement uncertainties of PT ,APTT and Fbg were evaluated by adopting the Top‐Down method .Results The relative synthesis standard uncertainty (uc ,% ) of PT ,APTT and Fbg detected by the CA7000 automatic blood coagulation ana‐lyzer ,with the IQC data combining with the EQA data of the National Clinical Laboratory Center were 4 .10% ,5 .46% and 4 .71%respectively .With data of IQC combining with EQA data of Jiangsu Provincial Clinical Laboratory Center ,the assessed uc (% ) of PT ,APTT and Fbg were 3 .96% ,4 .38% and 6 .17% respectively .All uncertainties were lower than the target uncertainties set ac‐cording to CLIA′88 .Conclusion Adopting the Top‐Down method combining with EQC data for evaluating the measurement uncer‐tainty of PT ,APTT and Fbg detected by the CA7000 automatic blood coagulation analyzer can reflect the measurement uncertainty of this method under usual condition and is a economical and feasible way with some clinical application value .关键词
自上而下法/测量不确定度/质控数据/凝血项目Key words
Top-Down method/measurement uncertainty/quality control data/coagulation item引用本文复制引用
崔明,鞠少卿,保方,景蓉蓉..基于质控数据用Top-Down方法评定凝血检验项目测量不确定度[J].检验医学与临床,2017,14(1):1-2,6,3.基金项目
国家自然科学基金资助项目（81201349）；江苏省南通市前沿与关键技术创新项目（M S22015049）。 （）
