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Kim, Kim, Kim, Han, Paik, Yu, Park, Cha, Kim, Kim, and Han: Comparison between the Portable Prothrombin Time Self Monitor CoaguChek XS and a Standard Laboratory Method, Sysmex CA-1500 for Monitoring Anticoagulant Therapy of Outpatients
Original Article
Korean Circulation Journal

Korean Circulation Journal 2007; 37(5): 216-220.

Published online: 31 May 2007

DOI: https://doi.org/10.4070/kcj.2007.37.5.216

Comparison between the Portable Prothrombin Time Self Monitor CoaguChek XS and a Standard Laboratory Method, Sysmex CA-1500 for Monitoring Anticoagulant Therapy of Outpatients

Ja Won Kim, MD1, Moo Hyun Kim, MD1, Kyung Ho Kim, MD1, Jin Han, MD1, Jeung Hoan Paik, MD1, Long Hao Yu, MD1, Tae Ho Park, MD1, Kwang Soo Cha, MD1, Young Dae Kim, MD1, Kyung Eun Kim, MD2, Jin Yeong Han, MD2

1Department of Internal Medicine, College of Medicine, Dong-A University, Busan, Korea.

2Department of Laboratory Medicine, College of Medicine, Dong-A University, Busan, Korea.

Corresponding author (kimmh@dau.ac.kr)

Received 5 December 2006       Revised 23 February 2007       Accepted 16 April 2007

© 2007, The Korean Society of Circulation

Abstract

Background and Objectives

Patients on oral anticoagulation therapy (OAT) require regular monitoring of the prothrombin time (PT) and dosage adjustment to prevent thromboembolic diseases without the risk of hemorrhage. Portable self PT monitors have been recently developed because the standard PT measurements are complicated and take considerable time. This study compared the International normalized ratio (INR) results that were obtained with using the CoaguChek XS device (Roche Diagnostic, Mannheim, Germany) with those obtained using a standard laboratory method Sysmex CA-1500 (Sysmex Corporation, Kobe, Japan) in the patients on OAT and also a healthy control group.

Subjects and Methods

100 outpatients on OAT and 20 healthy controls were enrolled on a volunteer basis after providing informed consent at the Dong-A University Hospital. The outpatients and the healthy control group provided us the INR measurements with using both the CoaguChek XS and the Sysmex CA-1500.

Results

The coefficients of variation for CoaguChek XS and Sysmex CA-1500 were less than 10%. The PT (INR) results of CoaguChek XS and Sysmex CA-1500 were 2.0±0.7 and 2.2±0.7, respectively (p<0.001). There was a good correlation between CoaguChek XS and Sysmex CA-1500 (r=0.974, p<0.001). On the regression analysis, the slope of the regression line was 0.9197 and the y-intercept was 0.0058. On the Bland-Altman analysis, the INR mean difference (bias) between the two methods (CoaguChek XS INR-Sysmex CA-1500 INR) was -0.2 and the limit of agreement was +0.168~-0.568.

Conclusion

The measurement with using CoaguChek XS has high repeatability, rapid availability and good accuracy that are comparable to the standard laboratory method. Therefore, CoaguChek XS can be a valuable tool for the self-monitoring of patients on OAT.

Keywords: Prothrombin time, Anticoagulants, Monitor

Figures and Tables

Fig. 1
Comparison between CoaguChek XS and Sysmex CA-1500. Regression analysis: y=0.9197x-0.0058.
kcj-37-216-g001
Fig. 2
Bland-Altman analysis of comparison between CoaguChek XS and Sysmex CA-150. The INR mean difference (bias) between the two methods (CoaguChek XS INR-Sysmex CA-1500 INR) was -0.2 and the limit of agreement was +0.168~-0.568 PT (INR). INR: international normalized ratio.
kcj-37-216-g002
Table 1
Clinical characteristics of patients (n=100)
kcj-37-216-i001
Table 2
Comparison of INR categories for Coaguchek XS and Sysmex CA-1500 among patients and healthy controls
kcj-37-216-i002

PT: prothrombin time, INR: international normalized ratio

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