两台凝血仪国际标准化比值的一致性比对分析  

Comparative Analysis on Consistency of International Normalization Ratio Measured by Two Blood Coagulation Analyzers

作　　者：张开民[1] 梁影[1] 王海涛[1] 汪从祥[1] 

机构地区：[1]亳州市人民医院检验科,安徽亳州236800

出　　处：《中国医疗设备》2014年第3期34-36,148,共4页China Medical Devices

摘　　要：目的分析两台不同厂家生产的凝血仪所测凝血酶原时间国际标准比值(INR)有无差别及差别可否被接受,能否为病人用药监测提供一致性参考。方法根据美国临床实验室标准化协会(CLSI)EP9-A2文件内容,对我科2台凝血仪所测的INR值进行比对和偏倚评估。以法国STAGO compact型凝血仪为参比仪器,日本Sysmex CA7000凝血仪为试验仪器;以我国卫生部规定的<美国临床实验室改进修正案CLIA’88允许总误差(TEa)的1/2为偏倚可接受标准,并对最终统计数据进行t检验。结果两台仪器所测得INR值偏倚<CLIA’88允许总误差(TEa)的1/2,并且<生物学变异TEa的期望值,t检验统计分析(P>0.5)两结果间无显著性差异。结论 STAGO和Sysmex凝血仪所测INR值结果间无显著性差异,偏倚可被接受,可为临床提供一致性参考结果。Objective To analyze the difference of international normalization ratio （1NR） of prothrombin time between two coagulation analyzers and their difference acceptability, and whether it can provide consistency reference for drug treatment of patients. Methods According to the file contents of the American Clinical Laboratory Standards Institute （CLSI） EP9-A2, method comparison and bias evaluation of INR are carried out in our department from two blood coagulation analyzers. With the bias acceptance criteria of the Ministry of Health in China less than the half of the total error （TEa） allowed by the United States Clinical Laboratory Improvement Amendment （CLIA） ＇88, this study chose French STAGO compact blood coagulation analyzer as reference instrument, Japan Sysmex CA7000 coagulation analyzer as testing instrument, and then performed t test by using statistical data from the two instruments. Results The bias value of 1NR measured by two instruments was less than the half of TEa allowed by CLIA ＇88, and less than the TEa expected by the biological variation. There was no significant difference between the two instruments by t test statistics （P〉0.5）. Conclusion INR value between the two instruments has no significant difference, and bias can be accepted. This result showed that the two instruments can provide consistent reference results in clinic.

关 键 词：凝血仪 凝血试剂 凝血酶原时间 INR 

分 类 号：R446.1[医药卫生—诊断学] TH776[医药卫生—临床医学]