Disciplines of Public Health, The University of Adelaide, Adelaide, South Australia, Australia.
Pathology. 2010 Feb;42(2):155-9. doi: 10.3109/00313020903494045.
To assess the level of agreement between international normalised ratio (INR) results obtained from pathology laboratories and point of care testing (PoCT) devices used in a general practice setting.
INR pathology results were collected from multiple pathology laboratories and CoaguChek S PoCT devices over a 6 month period. Agreement was assessed using both clinically relevant agreement and the Bland Altman method.
Analysis was based on 1664 dual measurements collected on 417 patients from 26 general practices across Australia. The percentage of dual measurements satisfying the expanded and narrow agreement criteria were 91% and 89%, respectively. The mean difference in results and the 95% limits of agreement depended on the average INR result: mean difference = -0.30 + 0.08 x average; 95% limits of agreement = -0.30 + 0.08 x average +/- 0.77.
The current study provides further evidence that PoCT is an acceptable alternative to pathology laboratory testing in a general practice setting. The Bland Altman method is a useful and flexible tool for assessing agreement. Limits of agreement should be reported in future method comparison studies to assist clinicians in patient management.
评估在一般实践环境中，从病理学实验室获得的国际标准化比值（INR）结果与即时检测（PoCT）设备之间的一致性水平。
在 6 个月的时间内，从多个病理学实验室和 CoaguChek S PoCT 设备收集 INR 病理学结果。使用临床相关一致性和 Bland Altman 方法评估一致性。
分析基于来自澳大利亚 26 家普通诊所的 417 名患者的 1664 对双测量值。满足扩展和狭义一致性标准的双测量值百分比分别为 91%和 89%。结果的平均差异和 95%的一致性界限取决于平均 INR 结果：平均差异= -0.30 + 0.08 x 平均；95%的一致性界限= -0.30 + 0.08 x 平均 +/- 0.77。
本研究进一步证明，PoCT 是一般实践环境中替代病理学实验室检测的可接受方法。Bland Altman 方法是评估一致性的有用且灵活的工具。未来的方法比较研究应报告一致性界限，以帮助临床医生进行患者管理。
