新指南CLSI EP9-A3在凝血分析仪比对中的研究与运用  

The application of new Guidelines CLSI EP9-A3 in the blood coagulation analyzer comparison

作　　者：施雄飞[1] 林云[1] 张兴宗[1] 刘晓敏[1] 刘曦[1] 詹倩[1] SHI Xiongfei LIN Yun ZHANG Xingzong LIU Xiaomin LIU Xi ZAN Qian(Department of Clinical laboratory, The Traditional Chinese Medicine Hospital of Yunnan ,Kunming 650021 ,China,)

机构地区：[1]云南省中医医院检验科,昆明650021

出　　处：《检验医学与临床》2017年第13期1901-1902,1905,共3页Laboratory Medicine and Clinic

摘　　要：目的运用美国临床和实验室标准化协会(CLSI)EP9-A3指南对该科室2台不同凝血检测仪进行检测结果比对。方法以STAGO-Evlution凝血分析仪为参照系统(X),STAGO-Compact凝血分析仪为实验系统(Y),依据CLSI EP9-A3文件要求,分别测定40例标本的血浆凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)、血浆纤维蛋白原(FIB)。结果应用ESD法进行离群值检验,选用最佳回归模型拟合回归方程,计算各检测项目95%置信区间(CI)和医学决定水平处的偏倚,≤1/2 TEa为可接受标准。结果 ESD法未发现离群值点。PT、FIB差值具有恒定CV变化,采用加权最小二乘法(WLS)回归分析;APTT差值为混合变化,使用Passing-Bablok回归分析;应用回归方程直接计算医学决定水平处的偏倚及回归各项目可信区间,其偏倚均小于可接受标准。结论 STAGO-Evlution与STAGO-Compact 2台凝血仪检测PT、APTT、FIB结果具有可比性。Objective Using the guidelines CLSI EP9-A3 in this department to compare testing results in different clotting detector. Methods PT（plasma prothrombin time）,APTT（activated partial thromboplastin time）,FIB（plasma fibrinogen）. In serum of 40 specimens were measured by STAGO-Evlution of blood coagulation analyzeras reference system（X） and STAGO-Compact blood coagulation analyzer for experiment system（Y） ,according to CLSI EP9-A3 document requirements. Outlier test were analyze by application of ESD technique . Those bias of 95% confidence interval and Medical decision level were tested by the best regression model fitting regression equation. 1/2 TEa or less were acceptance criteria . Results Outliers were not identified through the ESD. Those CV of PT and FIB . Were not chang by Using the WLS regression analysis. APTT were mix change by the Passing - Bablok regression analysis. Those bias of medical decision level and 95 % confidence interval were accepted . Conclusion The resuits of the PT,APTT,FIB were measured by STAGO-Evlution and STAGO-Compact were consistent .

关 键 词：EP9-A3文件 结果比对 凝血分析仪 

分 类 号：R446.112[医药卫生—诊断学]