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Clinical Chemistry 53: 1555-1556, 2007; 10.1373/clinchem.2007.088435
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(Clinical Chemistry. 2007;53:1555-1556.)
© 2007 American Association for Clinical Chemistry, Inc.


Letters to the Editor

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

Steve Kitchena, Dianne Kitchen, Ian Jennings, Tim Woods and Isobel Walker

UK NEQAS Blood Coagulation, Rutledge Mews, Sheffield Teaching Hospitals, NHS Foundation Trust, Sheffield, United Kingdom

aAddress correspondence to this author at: UK NEQAS Blood Coagulation, Rutledge Mews, 3 Southbourne Rd., Sheffield Teaching Hospitals NHS Foundation Trust S10 2QN, United Kingdom. Fax 44-0-114-271-2149; e-mail Steve.kitchen@sth.nhs.uk.

The first 20% of the full text of this article appears below.


To the Editor:

In a recent publication Poller et al. (1) described quality assessment (QA) of CoaguChek (CUC) point-of-care (POC) international normalized ratio (INR) monitors and compared 2 procedures. The study compared the proportion of 523 CUC monitors having unsatisfactory performance as indicated by either a >15% deviation of INR results from the INR assigned to 5 lyophilized QA plasmas or a >15% deviation from the overall median of INRs obtained on the monitors included in the survey. The INRs assigned to QA plasmas had been derived from a full calibration in compliance with WHO-recommended procedures and a local mean normal prothrombin time.

The CUC device is calibrated by the manufacturer for use with non-anticoagulated whole blood. Patients using the device analyze whole blood and not plasma. Furthermore, the calibration procedure employed by Poller et al. (1) used whole blood samples to derive the International Sensitivity Index for assigning INRs to the lyophilized plasma samples. . . . [Full Text of this Article]







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