Moon Ju Ryoung, Jeong Soo In, Huh June, Lee Heung Jae, Park Pyo Won, Kang I-Seok
Cardiac & Vascular Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Gangnam-gu, Seoul, Korea 135-710.
Ann Clin Lab Sci. 2010 Summer;40(3):247-51.
The CoaguChek XS international normalized ratio (INR) assay was compared to INR assay by a standard laboratory method in children with heart disease on anticoagulant therapy. The data comprised 120 pairs of INR values for 42 patients (age <16 yr) who attended a cardiology clinic between 1 May 2007 and 30 January 2008. Parallel INR assays by the CoaguChek XS and the standard method were performed within 1 hr by a single qualified technician and the paired results were evaluated by linear regression and Bland-Altman analysis. The mean difference in the INR values was -0.08 +/- 0.04 units (p = 0.63); the difference between the two results was consistently <0.5 INR units. The slope of the regression line was 0.98 (95% CI: 0.96 to 1.01) and the y-intercept was 0.014 (95% CI: -0.01 to 0.04). In the Bland-Altman analysis, the mean difference in INR between the two methods was 0.08 units and values for 99.4% of the patients fell within the limit of agreement (-0.17 to 0.28 units). In summary, INR assays in children by the CoaguChek XS device are as accurate as the standard method, but faster and more convenient.
在接受抗凝治疗的心脏病患儿中，将CoaguChek XS国际标准化比值（INR）检测与标准实验室方法进行INR检测相比较。数据包括2007年5月1日至2008年1月30日期间在心脏病诊所就诊的42例（年龄<16岁）患者的120对INR值。由一名合格技术人员在1小时内采用CoaguChek XS和标准方法并行进行INR检测，并通过线性回归和Bland-Altman分析评估配对结果。INR值的平均差异为-0.08±0.04单位（p = 0.63）；两个结果之间的差异始终<0.5 INR单位。回归线的斜率为0.98（95% CI：0.96至1.01），y轴截距为0.014（95% CI：-0.01至0.04）。在Bland-Altman分析中，两种方法之间INR的平均差异为0.08单位，99.4%的患者的值落在一致性界限内（-0.17至0.28单位）。总之，CoaguChek XS设备在儿童中进行的INR检测与标准方法一样准确，但更快且更方便。
