普利生凝血试剂在Sysmex CA-530全自动血凝仪上的应用评价

Application evaluation of domestic Precil coagulation reagent in Japan Sysmex coagulometer

目的 :比对国产普利生凝血试剂与原装进口Siemens试剂在日本Sysmex CA-530全自动血凝仪上使用结果有无显著差异。方法:分别用普利生凝血酶时间(prothrombin time,PT)和活化部分凝血活酶时间(actived partial thromboplastin time,APTT)测定试剂与原装Siemens试剂检测临床标本,统计结果后进行分析。结果:国产普利生PT和APTT测定试剂与原装Siemens试剂检测结果无显著差异,PT、国际化标准比率(international normalized,INR)与APTT值偏差均符合美国CLIA'88标准要求。结论:国产普利生PT和APTT测定试剂与原装试剂相关性良好,可以替代Siemens试剂在Sysmex CA-530全自动血凝仪上使用。

Objective To investigate the difference between domestic Precil coagulation reagent and imported reagent Siemens used in Japan Sysmex CA-530 automated coagulometer. Methods The clinical specimens were tested for prothrombin time（PT） and activated partial thromboplastin time（APTT） with Precil reagents and Siemens reagents respectively,and then the results were analyzed statistically. Results There were no significant differences between the results of PT and APTT by Precil and Siemens reagents, and Clinical Laboratory Improvement Amendments of 1988（CLIA ＇88） was met in biases of PT, international normalized ratio（INR） and APTT. Conclusion There is high correlation between Precil PT and APTT reagents and the original ones, which can replace Siemens reagents for Sysmex Coagulometer.