• Mayo Clinic proceedings · Feb 2005

    Comparative Study Clinical Trial

    Importance of device evaluation for point-of-care prothrombin time international normalized ratio testing programs.

    • Robert D McBane, Cindy L Felty, Mindy L Hartgers, Rajeev Chaudhry, Lisa K Beyer, and Paula J Santrach.
    • Department of Internal Medicine and Division of Cardiovascular Diseases, Mayo Clinic College of Medicine, Rochester, Minn 55905, USA. mcbane.robert@mayo.edu
    • Mayo Clin. Proc. 2005 Feb 1;80(2):181-6.

    ObjectiveTo determine the accuracy of 2 commercially available point-of-care devices relative to plasma international normalized ratio (INR) values.Patients And MethodsPoint-of-care INR testing was performed with the CoaguChek and ProTime 3 devices in consecutive patients attending an anticoagulation clinic between June 18, 2003, and August 6, 2003. Results were compared with plasma INRs using a sensitive thromboplastin (International Sensitivity Index, 1.0).ResultsNinety-four patients agreed to participate in the study. Relative to the plasma INR, values were in agreement +/-0.4 INR unit 82% and 39% of the time for the CoaguChek and ProTime 3 devices, respectively. The mean +/- SD CoaguChek INRs were 0.2+/-0.31 unit lower, whereas ProTime 3 INRs were 0.8+/-0.68 unit higher than plasma INR values. Treatment decisions based on these data would have resulted in inappropriate dose adjustments 10% and 22% of the time for these 2 respective devices. Correlation with plasma was greater for the CoaguChek (r2=0.90) compared with the ProTime 3 device (r2=0.73).ConclusionsOptimal warfarin treatment requires accurate measurement of the INR. The choice of a point-of-care device for INR management depends on the reliability of INR data generated by the device.

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