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Annals of Clinical & Laboratory Science 38:37-40 (2008)
© 2008 Association of Clinical Scientists

Evaluation of the Roche CoaguChek XS Handheld Coagulation Analyzer in a Cardiac Outpatient Clinic

Myung-Hyun Nam1, Kyoung Ho Roh1, Hui-Nam Pak2, Chang Kyu Lee1, Young-Hoon Kim2, Kap No Lee1 and Yunjung Cho1
1 Departments of Laboratory Medicine and 2 Internal Medicine, College of Medicine, Korea University, Seoul, Korea

Address correspondence to Dr. Yunjung Cho, Department of Laboratory Medicine, Korea University Medical College, 126-1 Anam-dong, Sungbuk-gu, Seoul, Korea 136-705; tel 82 2 920 5612; fax 82 2 920 5538; e-mail eqcho1ku{at}korea.ac.kr.

This study evaluated the performance of a handheld coagulation analyzer for measurements of capillary blood specimens of 93 outpatient cardiology patients with atrial fibrillation who were receiving oral anti-coagulant therapy. The international normalized ratio (INR) results of the CoaguChek XS system (Roche Diagnostics) were compared with those obtained in the central laboratory with citrated venous blood specimens using the ACL9000 coagulation analyzer (Instrumentation Laboratory). The INR results for prothrombin time by the CoaguChek XS analyzer were closely correlated with the central laboratory’s results in the INR range of 0.96~8.53 (r = 0.964). A statistically significant difference was noted between 2 lots of test strips, but the difference was miniscule (mean ± 95% confidence interval: 0.04±0.02). The CV of 8 replicate assays with the CoaguChek XS for a blood specimen with high INR value (INR=3.9) was 1.4%; for a blood specimen with medium INR value (INR=1.3), the CV of 8 replicate assays was <0.1%. This study shows that the CoaguChek XS analyzer is precise and reliable for assessment of INR results at clinically significant ranges in cardiac outpatients.

Keywords: coagulation analyzer, point-of-care testing, prothrombin time, INR






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