CoaguChek® XS Plus & Pro systems

Point-of-care coagulation monitoring for healthcare professionals

  • Convenient, portable and user-friendly systems for monitoring oral anticoagulation therapy
  • Determine the International Normalized Ratio (INR) (Prothrombin Time (PT)) value from a single drop of capillary whole blood (just 8 μL)
  • Immediate and accurate results 
  • Developed exclusively for professional use
  • Results are comparable to those obtained with the patient’s device – the CoaguChek XS system – as they use the same technology and the same strips
  • Both instruments can be connected to a wireless infrared printer
  • Simple, precise and reliable

For more detailed information please visit www.CoaguChek.com

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CoaguChek Plus Pro 01
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  • Sample types: Fresh capillary or non-anticoagulated venous whole blood 
  • Test principle: Electrochemical measurement technique 
  • User interface: Large touchscreen with icons for intuitive operation
  • Memory capacity: 2,000 test results with date and time
  • Built-in quality control checks each and every strip automatically
  • Liquid control available for dedicated QC requirements
  • Automatic code chip identification to match lot-specific information with test strips in use
  • Extended data management capabilities:
    • industry standard POCT1-A (can be connected to any POC IT solution) 
    • complete documentation of results including patient and operator identification
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On the spot adjustment of patient treatment – no need to wait for lab results

The CoaguChek® XS Plus & Pro systems deliver benefits in a number of key areas:

Fast and safe decision making

  • Immediate results mean patient treatment can be adjusted on-the-spot in the comfort of the physician’s office
  • Patient barcode scanner (CoaguChek XS Pro) and operator identification enhance both safety and workflow
  • Onboard Quality Control (QC) for every strip plus optional liquid controls
  • Optional operator and QC lockouts to meet any regulatory requirements and ensure consistency of INR results
  • Extensive data management and connectivity options

Reliable results

  • No heparin interference (both unfractionated and low molecular weight) at therapeutic levels
  • Lab-equivalent accuracy and precision through use of human recombinant thromboplastin with an ISI of 1.0 to enhance test accuracy (compliant with WHO recommendations) and a CV below 4.5 %1, 2

Simple fingerstick test

  • Most patients prefer having capillary blood testing over having blood drawn from a vein3
  • Easy blood application: top or side dosing

Immediate results in alternative site testing (AST) facilities

  • AST reduces the rate of complications of patients: Studies indicate a 59% reduction in major hemorrhagic events and a 68% reduction in thrombotic events when care is managed by an anticoagulation management service4

Combination of warfarin plus INR monitoring is a proven success

  • Guarantee increased compliance5, 6
  • Keep costs under control7, 8 
  • Ensure that even subgroups of patients with special conditions are treated correctly5

1: Validation of the international normalized ratio (INR) in a new point-of-care system designed for home monitoring of oral anticoagulation therapy. Plesch W, van den Besselaar AM PH. Int. Jnl. Lab. Hem. 2009, 31, 20–25.

Summary
This study was performed to confirm the correct INR results received from two routinely manufactured lots of test strips when compared with the international reference preparations (IRP) rTF/95 and ERM-AD149.

The results of the study confirm the successful calibration of two lots of the CoaguChek XS system, demonstrate the validity of the calibration concept and prove the accuracy of the system in comparison with the IRP. Clinical decisions in oral anticoagulation therapy may be reliably made upon the INR results of the system.

2: Results of the performance verification of the CoaguChek XS system. Plesch W, Wolf T, Breitenbeck N, Dikkeschei LD, Cervero A ., Perez PL, van den Besselaar AM HP. Thromb Res. 2008;123(2):381-9.

Summary
The first paper reporting a performance verification study of a point-of-care (POC) monitor for prothrombin time (PT) testing according to the requirements given in chapter 8 of the International Organization for Standardization (ISO) 17593:2007 standard "Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy".

The system demonstrated a high level of trueness and accuracy, and low imprecision in INR testing. It can be concluded that the CoaguChek XS system complies with the requirements in chapter 8 of the ISO standard 17593:2007.

3: Patient preferences for capillary vs. venous INR determination in an anticoagulation clinic: a randomized controlled trial. Woods, K., Douketis, J.D., Schnurr, T., Kinnon, K., Powers, P. et al. (2004). Thromb Res 114(3), 161-165.

Summary
Although previous studies suggest that capillary blood monitoring of the international normalize ratio (INR) is rapid and reliable, patient preferences for the method of blood drawing have not been investigated.

The findings support the routine use of capillary blood testing, using a portable monitor, for the management of patients in outpatient anticoagulation clinics.

4: Optimizing the efficacy and safety of oral anticoagulant therapy: high-quality dose management, anticoagulation clinics, and patient self-management. Ansell, J.E. (2003). Semin Vasc Med 3(3), 261-270.

Summary
Poor management of oral anticoagulation is a prime factor influencing the occurrence of adverse events.

As a result of these problems, special programs or anticoagulation management services (AMSs) have developed to manage oral anticoagulation. Such programs have demonstrated a significant improvement in outcomes compared with traditional or usual care (UC) by individual physicians. With the introduction of point-of-care prothrombin time monitors, the potential for patient self-testing and self-management has developed. Studies show the possibility of even further improvement in outcomes compared with UC, although the differences from those achieved with an AMS are less impressive.

5: 2011 ACCF/AHA/HRS focused update on the management of patients with atrial fibrillation (update on dabigatran): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Wann LS, Curtis AB, Ellenbogan KA, Estes DAM, Ezekowitz MD, Jackman WM, January CT, Lowe JE, Page RL, Slotwiner DJ, Stevenson WG and Tracy CM. J Am Coll Cardiol 2011;57:1330-1337

Summary
Dabigatran is useful as an alternative to warfarin for the prevention of stroke and systemic thromboembolism in patients with paroxysmal to permanent AF and risk factors for stroke or systemic embolization who do not have a prosthetic heart valve or hemodynamically significant valve disease, severe renal failure (creatinine clearance <15 mL/min) or advanced liver disease (impaired baseline clotting function).

Selection of patients with AF and at least 1 additional risk factor for stroke who could benefit from treatment with dabigatran as opposed to warfarin should consider individual clinical features, including the ability to comply with twice-daily dosing, availability of an anticoagulation management program to sustain routine monitoring of INR, patient preferences, cost, and other factors.

6: Anticoagulation control and prediction of adverse events in patients with atrial fibrillation: a systematic review. Wan Y, Heneghan C, Perera R, Roberts N, Hollowell J, Glasziou P, Bankhead C and Xu Y. Circ Cardiovasc Qual Outcomes 2008;1:84-91

Summary
Until 2008, there has been no systematic examination of the relationship between international normalized ratio (INR) control measurements and the prediction of adverse events in patients with atrial fibrillation on oral anticoagulation.

In atrial fibrillation patients receiving orally administered anticoagulation treatment, TTR and percentage of INRs in range effectively predict INR control. Data from retrospective studies support the use of TTR to accurately predict reductions in adverse events.

7: Hospital budget implications of substituting dabigatran for warfarin in an anticoagulation service. Clin Appl Thromb Hemost. Atay JK, Fiumara K, Piazza G, Fanikos J and Goldhaber SZ Electronic version published August, 2011

Summary
The aim of the study was to assess hospital budget implications of substituting dabigatran for warfarin in patients enrolled in a large anticoagulation service.

Substituting dabigatran for warfarin will result in increased expense due to drug cost.

8: Point of care international normalized ratio (INR) monitoring devices for patients on long-term oral anticoagulation therapy: an evidence-based analysis. Medical Advisory Secretariat, Ontario Health Technology Assessment Series 2009; 9(12)

Summary

What is the cost-effectiveness of POC INR monitoring devices in various settings compared to standard laboratory-based INR determination?

POC strategies are cost-effective versus traditional INR laboratory testing. The healthcare staff testing strategy has potential cost savings because of one device per multiple patients. The PSM strategy appears to be the most cost-effective method i.e. this population may be more inclined to adjust their INRs more readily, thereby keeping INR values within target ranges.