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Abstract

Aim: To evaluate the accuracy of the CoaguChek XS international normalised ratio (INR) monitor
compared to the laboratory method.
Methods: The accuracy and ease of use of the recently marketed CoaguChek XS portable INR
monitor was evaluated in 17 patients involved in a trial of warfarin home-monitoring. INR results from
the monitor were compared to the laboratory method. Clinical applicability was measured by
discrepant INR values, defined in the literature by expanded and narrow agreement criteria, and by the
proportion of INR values differing by more than 15% and 20% from the laboratory method.
Results: Participants provided 59 comparison INR measurements for analysis. The paired results were
highly correlated (r = 0.91). Expanded and narrow agreement between paired INR values occurred
100% of the time. Only three CoaguChek XS (5.1%) results differed by >15% compared to the
laboratory method; no results differed by more than 20% or were more than 0.5 INR units discrepant.
Conclusions: In the hands of patients the CoaguChek XS demonstrated good correlation with
laboratory determination of INR and compared very well with expanded and narrow clinical agreement
criteria. Both patients and doctors were highly satisfied with the accuracy and ease of use of the
CoaguChek XS.

Item Type:	Article
Authors/Creators:	Bereznicki, LRE and Jackson, SL and Peterson, GM and Jeffrey, EC and Marsden, KA and Jupe, DML
Keywords:	warfarin, international normalised ratio, point-of-care, monitor, accuracy
Journal or Publication Title:	Journal of Clinical Pathology
Publisher:	BMJ Publishing Group
ISSN:	0021-9746
DOI / ID Number:	10.1136/jcp.2006.037820
Additional Information:	This article has been accepted for publication in JCP following peer review. The definitive copyedited, typeset version in the Journal of Clinical Pathology 2007;60:311-314 is available online at : http://jcp.bmjjournals.com/
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