Importance of device evaluation for point-of-care prothrombin time international normalized ratio testing programs.
OBJECTIVE
To determine the accuracy of 2 commercially available point-of-care devices relative to plasma international normalized ratio (INR) values.


METHODS
Point-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).


RESULTS
Ninety-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).


CONCLUSIONS
Optimal 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.
McBane
Robert D
RD
Department of Internal Medicine and Division of Cardiovascular Diseases, Mayo Clinic College of Medicine, Rochester, Minn 55905, USA. mcbane.robert@mayo.edu
Felty
Cindy L
CL
Hartgers
Mindy L
ML
Chaudhry
Rajeev
R
Beyer
Lisa K
LK
Santrach
Paula J
PJ
D000328:Adult; D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage; D019544:Equipment Failure Analysis; D005260:Female; D006801:Humans; D019934:International Normalized Ratio / Q000295:instrumentation*; D008297:Male; D008875:Middle Aged; D019095:Point-of-Care Systems; D011517:Prothrombin Time / Q000295:instrumentation*; D015203:Reproducibility of Results; D014859:Warfarin / Q000008:administration & dosage
D000925:Anticoagulants; D014859:Warfarin