Quality Assessment of CoaguChek Point-of-Care Prothrombin Time Monitors: Comparison of the European Community-Approved Procedure and Conventional External Quality Assessment

Precision and accuracy of CoaguChek S and XS monitors: The need for external quality assessment

“…The observations of the authors on accuracy are most important and their results are similar to those of the joint European Action on Anticoagulation (EAA)/European Concerted Action on Thrombosis (ECAT) study (10) where CoaguChek and CoaguChek S monitor results deviated in over 20% of tests by more than 15% INR from certified INR values on the same set of plasmas. They concluded that external quality assessment (EQA) and perhaps calibration of CoaguChek monitors seems mandatory.…”

Quality Assessment of CoaguChek Point-of-Care International Normalized Ratio Monitors: A Note of Caution

“…On the basis of their study results, Poller et al (1 ) concluded that a proportion of CUC monitors in current everyday use for dosage control gave unsatisfactory results. Our experience suggests that although this conclusion may be true for lyophilized plasmas, it should not be assumed that the same conclusion applies to whole-blood samples.…”

Novel analysis of clinically relevant diagnostic errors in point‐of‐care devices

“…Published papers have used a diverse array of techniques to assess agreement between INR measures. A standard developed in the UK determines that INR measures do not agree if they not within 15% of each other [12][13][14][15]. However, methods that use percentage difference to assess agreement have been shown to correspond poorly with clinical decision-making [16].…”