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KMID : 0383820080650060417
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Tuberculosis and Respiratory Diseases
2008 Volume.65 No. 6 p.417 ~ p.475
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Utility of CoaguChek XS for Monitoring the Prothrombin Time
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Park Ro-Jin
Sung Ki-Bum
Shin Jeong-Won
Shin Hee-Bong
Lee You-Kyeong
Kim Yong-Hyun
Kwon Kyung-Ock
Na Jong-Sung
Won Yong-Soon
Lee Nae-Hee
Choi Tae-Youn
Lee Yong-Wha
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Abstract
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Background: In order to achieve a maintenance level and to prevent hemorrhagic complications, regular monitoring
of the INR is mandatory for patients on oral anticoagulation therapy (OAT). A point-of-care instrument for INR
monitoring is convenient for users, but the accuracy of the results has been controversial, and so this calls for
exact evaluation of the point-of-care instrument that is used for INR monitoring.
Methods: From Aug 2007 through Feb 2008, 85 patients on OAT among the all the patients who were admitted
to Soonchunhyang University Bucheon Hospital were involved in this study. Parallel measurements of the PT INR
were performed using a CoaguChek-XS and, a CA-7000 laboratory reference instrument and the results were
analyzed. In addition, the patients’ clinical data, including the diagnosis and the frequency and interval of the
INR measurements, were also analyzed.
Results: Of the 85 patients, 25 were admitted more than once to undergo INR testing and the mean interval between
testing was 8.6 weeks with 39% and 38% of the tests being less than INR 2 units with using the CoaguChek-XS
and the reference method, respectively. The coefficients of variation of CoaguChek-XS were 4.50 and 2.45 for
the high and low INR patients, respectively. An excellent correlation was found between the two methods with
a R2 of 0.966 (p＜0.001). Through Bland-Altman analysis, the mean INR difference between the two methods was
0.13 with the limit of agreement being ?0.47∼＋0.72 with a 95% confidence interval. CoaguChek-XS was shown
to overestimate the INR value for patients with an increasing INR, as compared to the reference method.
Conclusion: CoaguChek-XS demonstrated great precision and accuracy for patients on OAT when compared to
the laboratory INR results. Accordingly, the instrument should help to monitor the INR in the patients on OAT.
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KEYWORD
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Prothrombin time, INR, CoaguChek-XS, Oral anticoagulant therapy
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