床旁即时检测凝血仪的INR检测性能验证  

The performance verification of CoaguCheck XS system in INR testing

作　　者：孔莹 刘泽金[2] 刘世国 

机构地区：[1]湖北中山医院检验科,湖北武汉430033 [2]武汉亚洲心脏病医院检验中心,湖北武汉430022

出　　处：《诊断学理论与实践》2011年第6期545-547,共3页Journal of Diagnostics Concepts & Practice

摘　　要：目的:验证Coagu Check XS凝血仪的国际标准化比值(INR)检测性能。方法:选取体检正常者140名,其中男性70名,女性70名,年龄25~45(34±8)岁;另选武汉亚洲心脏病医院心脏瓣膜置换术后口服华法林抗凝6周以上的门诊患者116例,其中男性67例,女性49例,年龄42~63(40±15)岁。参照ISO17593文件程序,评价CoaguCheck XS凝血仪检测INR的性能。结果:15名正常体检者与30例抗凝患者的INR范围为0.9~4.5,每例个体2次INR结果的重复性达到5%的要求,重复性得到验证。Coagu Check XS凝血仪与ACL TOP血凝仪INR检测结果的相关性R2为0.945,ACL TOP血凝仪检测结果较低,平均偏差为-0.08(95%置信区间:-0.12^-0.05),INR检测结果均达到了ISO17593的最小准确性验证要求,准确度得到了验证。根据120名正常体检者建立的INR参考区间为0.73~1.39。结论:Coagu Check XS凝血仪的INR检测性能达到了ISO17593的检测性能要求,可使用此仪器检测患者的INR。Objective To verify the performance of CoaguCheck XS Point-of-Care Testing（POCT） system in the testing of international normalized ratio（INR）.Methods Blood samples were taken from 140 normal healthy subjects aged 25 to 45（33.5±8.3）years（70 men and 70 women） and 116 patients aged 42 to 63（40.3±15.4）years（67 men and 49 women） who had taken warfarin for more than 6 weeks after replacement of heart valve.The performance of CoaguCheck XS system was evaluated in accordance with the International Organization for Standardization（ISO） 17593 standard.Results The results of INR testing in 15 normal healthy subjects and 30 patients taking warfarin ranged from 0.9 to 4.5,and the bias between the results of two duplicate INR testing of each sample was less than 5%.The correlation coefficient R2 between the results of CoaguCheck XS system and ACL TOP system was 0.945.Result of ACL TOP system was slightly lower than that of CoaguCheck XS system,and the mean bias was-0.08（95% confidence interval：-0.12 to-0.05）.The accuracy of CoaguCheck XS system met the minimal accuracy requirements of ISO 15793.The reference interval of INR established in accordance with 120 normal healthy subjects was from 0.73 to 1.39.Conclusions The performance of CoaguCheck XS system in INR testing met the requirements in ISO 15793.It could be used for examining the INR in patients.

关 键 词：国际标准化比值 床旁即时检测 性能验证 

分 类 号：R558.9[医药卫生—血液循环系统疾病]