Tuberculosis and Respiratory Diseases

The Korean Academy of Tuberculosis and Respiratory Diseases (대한결핵및호흡기학회)
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Utility of CoaguChek XS for Monitoring the Prothrombin Time

프로트롬빈시간 모니터링을 위한 CoaguChek XS의 유용성

  • Park, Rojin (Department of Laboratory Medicine, Soonchunhyang University Hospital) ;
  • Kim, Yong-Hyun (Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital) ;
  • Kwon, Kyung Ock (Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital) ;
  • Na, Jongsung (Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital) ;
  • Won, Yong Soon (Department of Thoracic and Cardiovascular Surgery, Soonchunhyang University Bucheon Hospital) ;
  • Sung, Ki Bum (Department of Neurology, Soonchunhyang University Bucheon Hospital) ;
  • Lee, Nae-Hee (Department of Internal Medicine, Soonchunhyang University Bucheon Hospital) ;
  • Choi, Tae Youn (Department of Laboratory Medicine, Soonchunhyang University Hospital) ;
  • Shin, Jeong Won (Department of Laboratory Medicine, Soonchunhyang University Hospital) ;
  • Shin, Hee Bong (Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital) ;
  • Lee, Yong-Wha (Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital) ;
  • Lee, You Kyeong (Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital)
  • 박노진 (순천향대학교병원 진단검사의학과) ;
  • 김용현 (순천향대학교 부천병원 진단검사의학과) ;
  • 권경옥 (순천향대학교 부천병원 진단검사의학과) ;
  • 나종성 (순천향대학교 부천병원 진단검사의학과) ;
  • 원용순 (순천향대학교 부천병원 흉부외과) ;
  • 성기범 (순천향대학교 부천병원 신경과) ;
  • 이내희 (순천향대학교 부천병원 내과) ;
  • 최태윤 (순천향대학교병원 진단검사의학과) ;
  • 신정원 (순천향대학교병원 진단검사의학과) ;
  • 신희봉 (순천향대학교 부천병원 진단검사의학과) ;
  • 이용화 (순천향대학교 부천병원 진단검사의학과) ;
  • 이유경 (순천향대학교 부천병원 진단검사의학과)
  • Received : 2008.11.10
  • Accepted : 2008.12.04
  • Published : 2008.12.30
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Abstract

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 $R^2$ 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.

연구배경: 와파린의 치료 효과를 유지하고 부작용을 방지하기 위해서는 수시로 프로트롬빈 시간을 모니터링 할 필요가 있다. 이러한 목적의 현장검사기기는 편리하지만 그 정확성에 있어서 문제가 될 수 있으므로 평가가 필요하다. 방 법: 2007년 8월부터 2008년 2월까지 순천향대학교 부천병원에 내원한 환자 중에서 경구용 항응고제(와파린)를 복용하는 85명의 환자들을 대상으로 하여 검사실 표준검사법과 CoaguChek-XS를 사용하여 각각 INR값을 측정하고 비교 분석하였다. 결 과: 전체 85명 환자 중 2번 이상 INR을 측정한 사람 은 모두 25명으로 이들의 INR 측정간격은 평균 8.6주이었고, CoaguChek-XS와 표준검사법에서 INR 2.0 미만의 측정값들이 각각 39%, 38%를 차지하였다. 와파린을 복용하는 환자에서 표준검사법으로 측정한 INR값이 높고, 낮은 두 명의 환자에서 각각 5번씩 측정한 결과 CoaguChek-XS의 변이계수는 각각 4.50, 2.45, CA-7000은 각각 1.67, 0.66이었다. 두 검사 기기간의 상관성은 $R^2$이 0.966으로서 우수하였으며 Bland-Altman 분석을 통해서 두 기기간 차이의 평균이 0.13이었고 일치범위의 한계(95% 신뢰구간)는 -0.47~+0.72이었다. 또한 INR 값이 증가할수록 CoaguChek-XS의 측정값은 표준방법에 비해서 높게 측정되는 경향을 보였다. 결 론: CoaguChek-XS는 정밀도가 좋고 기존의 검사실표준검사법과의 상관성이 우수하였다. 따라서 CoguChek-XS는 경구 항응고제 치료환자의 INR을 모니터링 하는데 도움이 될 것으로 생각된다.

Keywords

References

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