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Research Articles |
BACKGROUND: The CoaguChek S is the next-generation coagulation monitor for measuring the international normalized ratio (INR) that replaces the CoaguChek device. Studies are lacking comparing the CoaguChek S with local laboratory INR assessment to ensure its accuracy and precision for monitoring patients on anticoagulation. OBJECTIVE: To evaluate accuracy, precision, and technical ease-of-use of the CoaguChek S compared with laboratory measurements. METHODS: Accuracy was evaluated in 101 patients by parallel assessment of INRs (CoaguChek S and laboratory); precision was evaluated in 31 patients using duplicate INRs from CoaguChek S and laboratory and from liquid quality controls. Accuracy was determined using orthogonal regression, Bland-Altman plot, and clinical applicability (INRs discrepant in categorization of INR goal and resulting in different therapeutic decisions). Precision was examined by comparing mean difference +/- SD between repeated INRs from CoaguChek S and laboratory, coefficient of variation (CV), and coefficient of repeatability (CR). The influence of low and elevated INRs on accuracy and precision was also examined. To assess ease-of-use of the monitor, the number of technical errors was recorded. RESULTS: The CoaguChek S significantly correlated to laboratory measurement (r = 0.93); 16.7% of INRs resulted in discrepant categorization and 24.5% would have required a different therapeutic plan. The CV and CR compared well between CoaguChek S and laboratory (6% vs. 4.9%; 0.455 vs. 0.346, respectively). When subgroups of INR values <4.0 and <3.0 were evaluated, the precision improved with both methods. Precision, based on liquid quality controls, was good (CV 4.6% = low-level; 3.3% = high-level). The CoaguChek S was found to have an error rate of 1.8%. CONCLUSIONS: The CoaguChek S is an accurate and precise alternative to laboratory assessment of the INR at values <4.0; it is an efficient device with a low likelihood of errors during testing.
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  M.-H. Nam, K. H. Roh, H.-N. Pak, C. K. Lee, Y.-H. Kim, K. N. Lee, and Y. Cho Evaluation of the Roche CoaguChek XS Handheld Coagulation Analyzer in a Cardiac Outpatient Clinic Ann. Clin. Lab. Sci., January 1, 2008; 38(1): 37 - 40. [Abstract] [Full Text] [PDF]
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 P. Sie and A. Steib Central laboratory and point of care assessment of perioperative hemostasis: [Examens de l'hemostase perioperatoire realises en laboratoire et au lit du patient] Can J Anesth, June 1, 2006; 53(6_suppl): S12 - S20. [Abstract] [Full Text] [PDF]
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