不同全自动凝血仪检测结果的分析研究

目的:探讨不同全自动凝血分析仪检测结果是否具有可比性,同时对其检测结果临床可接受性进行评估,使不同全自动凝血分析仪检测结果标准化.方法:连续30天用SYSMEX CA- 1500及CA-7000全自动凝血分析仪同时检测并比对仪器配套定值质控物的PT、INR、APTT、FIB、TT值；同时连续30天利用两台仪器检测并对比新鲜血标本的PT、INR、APTT、FIB、TT值.结果:SYSMEX CA- 1500及CA-7000日间质控物各检测项目:PT、INR、APTT、FIB、TT变异系数均小于5％.CA- 1500及CA-7000全自动凝血分析仪检测新鲜血标本:PT、INR、APTT、FIB、TT统计分析结果,t检验其P值均＞0.05；相关系数r在0.993-0.999之间；两台仪器的偏差均符合1/2美国CLIA’88能力验证分析质量要求.结论:两台仪器PT、INR、APTT、FIB、TT的检测结果具有很好的相关性,经统计分析两台仪器检测结果无统计学意义.对不同凝血分析仪进行比对分析,不仅能够及时发现仪器存在的系统误差.而且使其检测结果具有很好的一致性,给临床可提供一个准确、可靠一致的实验室检测结果,使临床对疾病的诊断、疗效观察有一个统一的评判标准.

Comparative Analysis of Results with Different Automatic Blood Coagulation Analyzers

Objective:The purpose of our study was to analyze results comparability with different automatic blood coagulation analyzers and to estimate clinical acceptability in order to standardize the results with different automatic blood coagulation analyzers.Methods:The values of PT,INR,APTT,FIB and TT were obtained and compared in fresh blood samples and quality controls with instrument matching definite values with SYSMEX CA-1500 and CA-7000 analyzers for 30 days continuously.Results:The coefficient of variations of values of PT,INR,APTT,FIB and TT in inter-day quality controls with SYSMEX CA-1500 and CA-7000 were all less than 5%.Statistical analysis on values of PT,INR,APTT,FIB and TT in fresh blood samples with CA-1500 and CA-7000 analyzers indicated that the p values of t tests were more than 5% and correlation coefficients were between 0.993 and 0.999.The deviations of two instrument were accepted within quality range of USA deviation CLIA 1/2’88 ability requirements.Conclusions:The detected values of PT,INR,APTT,FIB and TT with the two analyzers had close correlation and there was not statistically significantly different.The comparative study on different blood coagulation analyzers was helpful for not only timely finding systematic error,but also ensuring good consistency of detected values in order to provide clinic accurate and consistent detected results and unified evaluation standard of disease diagnosis and observation of curative effect.