Comparison of the INR Values Measured by CoaguChek XS Coagulometer and Conventional Laboratory Methods in Patients on VKA Therapy.

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Warfarin, which is a widely used oral anticoagulant, has a narrow therapeutic window and requires regular international normalized ratio (INR) monitoring to maintain optimal anticoagulation. Recently, several portable coagulometers have been developed to measure INR levels. To compare the INR results obtained by a portable coagulometer (CoaguChek XS) and a standard laboratory method (STAGO STA-R). Overall, 433 consecutive patients (male: 191, median age: 61 [44-86] years) who were admitted to outpatient anticoagulation clinic were enrolled in this study. Each patient was tested for INR using portable CoaguChek XS and STAGO STA-R automatic laboratory coagulometer. Correlation between methods was assessed using the Pearson correlation test and Cohen κ test. Bland-Altman plot was used to identify mean difference and 95% limits of agreement. The mean INR values for CoaguChek XS and STAGO STA-R were 2.54 ± 1.17 and 2.79 ± 1.39, respectively. There was a strong positive correlation between the 2 methods ( r = .966; 95% confidence interval [CI]: 0.95-0.97, P < .001). The Bland-Altman analysis gave a mean difference of 0.26 ± 0.40 between the 2 methods, with a 95% limit of agreement of -0.54 to 1.05. In patients with INR values >5.0, there was only a moderate correlation ( r = .676; 95% CI: 0.38-0.89, P = .002), and the mean difference of INR tended to increase as mean INR values increased. There was a high overall agreement between the 2 methods (κ = .751; 95% CI: 0.69-0.80; P < .001). There was good consistency between traditional laboratory testing and CoaguChek XS coagulometer, which provides rapid and reliable INR analysis.