Accuracy of a Portable International Normalization Ratio Monitor in Outpatients Receiving Long-Term Oral Anticoagulant Therapy: Comparison with a Laboratory Reference Standard Using Clinically Relevant Criteria for Agreement

Abstract

The accuracy of a new, portable INR monitor (CoaguChek, Boehringer-Mannheim, Indianapolis, IN) was evaluated by comparing INR results from the portable monitor with results obtained by a laboratory-based method. Dual INR measurements (portable monitor, laboratory) were performed in 163 consecutive outpatients receiving warfarin. Agreement in dual INR measurements was defined based on clinically-relevant expanded and narrow criteria and statistical criteria. Agreement in dual INR measurements also was evaluated as a function of increasing INR. The proportion of dual INR measurements that satisfied the clinically-relevant expanded, and narrow agreement criteria was 90%, and 86%, respectively. Seventy-nine percent of all dual measurements were within 0.5 INR units. The accuracy of the portable monitor was greatest for INR values less than 3.0; above this INR level, the portable monitor underestimated laboratory INR values. The proportion of dual INR measurements within 0.5 INR units for laboratory INR ranges of <2.0, 2.0 –3.0, 3.1–4.0, and >4.0 was 98%, 87%, 57%, and 21%, respectively. We conclude that the portable INR monitor achieved a clinically acceptable level of accuracy when compared to the traditional laboratory method and provides a suitable alternative method of monitoring the INR in patients receiving warfarin.