CoaguChek® XS system

Coagulation self-testing made easy

  • Convenient, portable and user-friendly instrument for monitoring oral anticoagulation therapy
  • Determines the International Normalized Ratio (INR) (Prothrombin Time (PT)) value from a single drop of capillary whole blood (just 8 μL)
  • Immediate and accurate PT/INR results 
  • Ready for use anywhere at any time
  • Patients can use it for self-testing and self-management at home or on vacation
  • Simple, precise and reliable

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CoaguChek XS System

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CoaguChek XS with travel kit

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  • Sample types: Fresh capillary or non-anticoagulated venous whole blood
  • Measuring range: INR: 0.8 - 8.0; %Quick: 120 - 5; Seconds: 9.6 - 96
  • Test principle: Electrochemical determination of the Prothrombin Time (PT) after activation of coagulation with human recombinant thromboplastin
  •  Memory capacity: 300 test results with date and time
  • Built-in quality control checks each and every strip automatically 
  • Blood application: May be applied to top, left or right side of strip
  • Data transfer: Infrared interface
  • User interface: Icon-based LCD display; on/off, memory and set buttons
  • Comes with a travel kit

The simple, fast and reliable way to monitor oral anticoagulation therapy

Rapid, reliable results

  • 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

Improved patient outcomes

  • Frequent testing minimizes side effects and increases time spent within therapeutic range4

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

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

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, based on the INR results of the system.

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

The first paper reporting a performance verification study of a POC monitor for 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: Woods, K., Douketis, JD., Schnurr, T., Kinnon, K., Powers, P. et al. (2004). Patient preferences for capillary vs. venous INR determination in an anticoagulation clinic: a randomized controlled trial. Thromb Res 114(3), 161-165.

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: Heneghan, C., Alonso-Coello, P., Garcia-Alamino, JM., Meats, E., and Glasziou, P. (2006). Self-monitoring of oral anticoagulation: a systemic review and meta-analysis. Lancet 367,404-411

A systematic review and meta-analysis of all randomised controlled trials that assessed the effects of self-monitoring or self-management (self-testing and self-dosage) of anticoagulation compared with standard monitoring.
Self-management improves the quality of oral anticoagulation. Patients capable of self-monitoring and self-adjusting therapy have fewer thromboembolic events and lower mortality than those who self-monitor alone. However, self-monitoring is not feasible for all patients, and requires identification and education of suitable candidates.

5: 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., (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. J Am Coll Cardiol 57, 1330-1337

Dabigatran is useful as an alternative to warfarin for the prevention of stroke and systemic thromboembolism in patients with paroxysmal to permanent atrial fibrillation (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.