某血管外科即时护理装置与临床实验室分析仪国际标准化比值结果比较

Ayman H. K. Alserr, R. Menshawey, A. Kotb, Nourhan Hussein, Noha Kotp, Mahmoud Ashraf-Taha, Nouran Anwar, Asma M Abdalla, Menna Abdullah, Shaimaa Abol Ela, H. Khairy
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摘要

目的:本前瞻性比较研究旨在评估CoaguChek XS点护理系统(罗氏诊断有限公司,曼海姆,德国)与标准中心实验室国际标准化比率(INR)结果在血管外科病房中的准确性和有效性。方法采用中心实验室分析仪和CoaguChek XS测量的54对INR数据,采用类内相关系数进行比较。其他结果包括从患者的角度来看服务的时间和成本。采用Pearson相关检验评估相关性。进行Bland-Altman分析以确定平均差异和95%一致性限。采用Cohen κ检验评价两种方法的一致性。结果CoaguChek XS和标准实验室(Sysmex Ca-1500系统)的INR平均值;西门子医疗诊断公司(德国埃尔兰根)分别为1.21±0.28和1.24±0.43。所有108项测量的Pearson相关系数为(r) = 0.591(95%置信区间为0.38-0.74;P < 0.0001),表明中度正相关。总体类内相关系数为0.803(95%可信区间为0.324 ~ 0.707),信度较好。Bland-Altman分析显示偏差为0.035,95%的一致性范围为- 0.63至0.70。两种方法间存在显著性差异(κ = 0.694;, 0.108;95%置信区间为0.481-0.907)。获得CoaguChek XS结果,平均比标准实验室快213分钟。结论与标准实验室相比,CoaguChek XS具有正相关性,一致性强,可靠性好。因此,建议在医院环境中使用。
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A Comparison of International Normalized Ratio Results by Point-of-Care Device and Clinical Laboratory Analyzers in a Vascular Surgery Department
Purpose This prospective comparative study aims to evaluate the accuracy and validity of CoaguChek XS point-of-care system (Roche Diagnostics GmbH, Mannheim, Germany), compared with the standard central laboratory international normalized ratio (INR) results, in a vascular surgery ward. Methods Data based on 54 INR pairs, measured by the central laboratory analyzer and CoaguChek XS, were compared using the intraclass correlation coefficient. Other outcomes included the time and cost of the service from the patient's perspectives. Correlation was assessed using Pearson correlation test. Bland-Altman analysis was done to determine mean difference and 95% limits of agreement. Cohen κ test was done to assess agreement between the 2 methods. Results The mean INR values for CoaguChek XS and standard laboratory (Sysmex Ca-1500 system; Siemens Healthcare Diagnostics, Erlangen, Germany) were 1.21 ± 0.28 and 1.24 ± 0.43, respectively. The Pearson correlation coefficient in all 108 measurements was (r) = 0.591 (95% confidence interval, 0.38–0.74; P < 0.0001), indicating a moderately positive correlation. Overall intraclass correlation coefficient was 0.803 (95% confidence interval, 0.324–0.707) indicating good reliability. Bland-Altman analysis showed a bias of 0.035 and a 95% limits of agreement ranging from −0.63 to 0.70. There was substantial agreement between the 2 methods (κ = 0.694; SE, 0.108; 95% confidence interval, 0.481–0.907). CoaguChek XS results were obtained, on average, 213 minutes faster than the standard laboratory. Conclusions CoaguChek XS appears to have positive correlation, substantial agreement, and good reliability when compared with the standard laboratory. Thus, it is recommended to be used in hospital settings.
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