Boehlen Françoise, Reber Guido, de Moerloose Philippe
Haemostasis Unit, Department of Medicine, University Hospital, 1211 Geneva 14, Switzerland.
Thromb Res. 2005;115(1-2):131-4. doi: 10.1016/j.thromres.2004.06.023.
The objective of the study was to compare in anticoagulated patients the international normalized ratio (INR) measured with a new capillary whole-blood device, the i-STAT Portable Clinical Analyser, with conventional plasma INR obtained from the central laboratory.
Between-cartridge variability was first determined with two lyophilized controls with INR levels of 1.60 and 2.75 (n=10). Next, in 35 patients under different intensities of oral anticoagulation, capillary blood INR was measured with two i-STAT devices and was compared to central laboratory plasma INR (Innovin reagent and BCS analyser).
Between-cartridge coefficients of variation were 5% (95%, CI 3.4-9.1) and 3% (95%, CI 2.1-5.5) at INR levels of 1.60 and 2.75. Mean INR difference between the two i-STAT devices was 0.1, and the correlation coefficient was 0.98. Between i-STAT and central laboratory INR, the correlation coefficient was 0.95. Bias values were 0.04, 0.2, and -0.04 at INR levels of 2.0, 2.5, and 3.5, respectively.
The INR measured with the i-STAT Portable Clinical Analyser is precise and compares well with plasma INR performed in a central laboratory.
本研究的目的是比较在接受抗凝治疗的患者中，使用新型毛细管全血检测设备i-STAT便携式临床分析仪测量的国际标准化比值（INR）与从中心实验室获得的传统血浆INR。
首先使用两种INR水平分别为1.60和2.75的冻干对照品（n = 10）测定不同试剂盒间的变异性。接下来，在35例接受不同强度口服抗凝治疗的患者中，使用两台i-STAT设备测量毛细管血INR，并与中心实验室血浆INR（Innovin试剂和BCS分析仪）进行比较。
在INR水平为1.60和2.75时，不同试剂盒间的变异系数分别为5%（95%置信区间3.4 - 9.1）和3%（95%置信区间2.1 - 5.5）。两台i-STAT设备之间的平均INR差值为0.1，相关系数为0.98。在i-STAT与中心实验室INR之间，相关系数为0.95。在INR水平为2.0、2.5和3.5时，偏倚值分别为0.04、0.2和 -0.04。
使用i-STAT便携式临床分析仪测量的INR精确，与中心实验室检测的血浆INR具有良好的可比性。
