Sekisui CP3000与STA Compact Max凝血分析仪检测项目比对分析  

Evaluation of the comparability of the Sekisui CP3000 and STA Compact Max Coagulation Analyzer

作　　者：邹文毕 杨永强 黄光秀 廖美艳 史争虎 Zou Wenbi;Yang Yongqiang;Huang Guangxiu;Liao Meiyan;Shi Zhenghu(Department of Clinical Lab,Foshan Sanshui District People’s Hospital,Foshan 528100,China;Department of Clinical Lab,The Second Affiliated Hospital of Shaanxi University of Chinese Medicine,Xianyang 712000,China)

机构地区：[1]佛山市三水区人民医院检验科,佛山528100 [2]陕西中医药大学第二附属医院检验科,咸阳712000

出　　处：《现代仪器与医疗》2022年第3期46-49,共4页Modern Instruments & Medical Treatment

基　　金：2022年佛山市卫生健康局医学科研课题(20220413)。

摘　　要：目的探讨本科室两台不同全自动凝血分析仪对凝血酶原时间(Prothrombin time,PT)、活化部分凝血活酶时间(Activatedpartial thromboplastin time,APTT)、纤维蛋白原(Fibrinogen,FIB)和凝血时间(Thrombin time,TT)4项检测结果的可比性和一致性.方法使用与试剂配套的质控物对两台凝血仪进行稳定性分析;随机收集50例患者新鲜全血,分别在两台凝血分析仪上进行检测,并对结果进行相关性分析,求出回归方程和相关系数,最后采用Bland-Altman分析法对两台仪器的一致性进行评价.结果两台凝血分析仪各项目CV%均≤5.0,稳定性较好;测定PT、APTT、FIB和TT结果相关性良好,相关性系数分别为0.972、0.930、0.907和0.983;采用Bland-Altman法对两种仪器检测结果的一致性进行分析,PT、APTT、FIB和TT一致性界限外的点为8.0%、4.0%、4.0%和6.0%.结论两台仪器检测结果的一致性良好,但CP3000仪器测定结果受标本类型和药物影响较大.因此,在后续工作中对于特殊标本应固定仪器检测,同时应定期进行仪器间的比对,以保证检测结果的一致性和准确性.Objective To analyze the comparability of the PT,APTT,FIB and TT testing results of two different coagulation analyzers in our laboratory.Methods 50 patients with fresh plasma were randomly selected and the results obtained by these two coagulation analyzers.The correlation analysis of the results was performed to obtain the regression equation and correlation coefficient.The Bland-Altman analysis method was used to evaluate the consistency of the two coagulation analyzers.At the same time,use reagents and quality control materials for stability evaluation.In addition,the quality control was used to evaluate stability.Results In the precision study,the CV of two coagulation analyzers were less than 5%.In the regression analysis study,the results demonstrated the good agreement between each analyzer,and the correlation coefficients are 0.972,0.930,0.907 and 0.983,respectively.In the comparison study,the Bland-Altman analysis demonstrated the good agreement between each coagulation analyzer.The points out of the 95%limits of PT,APTT,FIB,and TT were 8.0%,4.0%,4.0%,and 6.0%,respectively.Conclusion Verification studies of the results were acceptable by two instruments coagulation analyzer.But in comparison studies of CP3000 coagulation analyzer,we saw that there are still problems with affected by some reasons(such as drugs,jaundice etc.).In the future work,the special sample should be tested by the coagulation analyzer with less influence,and compared regularly to ensure the consistency and accuracy of the test results.

关 键 词：凝血分析仪 一致性 Bland-Altman法 

分 类 号：R569[医药卫生—呼吸系统]