CoaguChek® INRange

IVD For in vitro diagnostic use.

For confident control of Vitamin K antagonist (VKA) therapy

CoaguChek® INRange is the connected self-testing meter that enables your patients to self-test their International Normalized Ratio (INR) whenever, wherever.*

The CoaguChek INRange system determines prothrombin time (PT) in fresh capillary blood, a coagulation test to monitor VKA therapy.

CoaguChek technology and quality have been recognized to facilitate VKA patient self-testing in a safe, accurate, and reliable manner.1

Male patient holding CoaguChek® INRange inserting a CoaguChek XS® PT Test PST test strip into the device
Benefits at a glance

Benefits at a glance

Built-in wireless, Bluetooth® technology allows you to be connected to your patients, who can now transmit their PT/INR results from their meter to you. This will help you to keep patients on track and in range–anytime, anywhere.

For more information about compatible software for data transfer with the CoaguChek® INRange meter please contact your local Roche Diagnostics customer support.

  • Keep patients engaged with reminders that can be set for important events such as when to test, take medication, or next doctor's appointment
  • On-screen help provides text guidance throughout the test procedure
  • The color display makes important information such as color-coded results noticeable so that they are easy to read and understand
  • Set up targets in your CoaguChek® INRange so your patients are notified if their results are out of that range
  • CoaguChek® INRange lets patients know if their most recent result is higher or lower than their last result to help them understand trends
  • The patient can enter up to 6 comments with each result to help them remember any past actions that may have affected the result

Studies show that patients who spend more than 70% of their time in the therapeutic range achieve better clinical outcomes, which can be facilitated through self-testing with CoaguChek® technology.1-4 Research indicates that patient self-testing not only increases time spent in the therapeutic range but also results in fewer extreme INR values, a reduction in thromboembolic events, improved quality of life, and greater treatment satisfaction, compared to standard care.4-13

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Overview

Ordering Information

Product specification Value
Measuring & sampling
Detection system Amperometric (electrochemical) determination of the PT time after activation of the coagulation with human recombinant thromboplastin
User interface Intuitive user interface with color display, on/off, enter, back, and up/down button
Sample application Outside the meter top and 2 sides: left or right,-dosing options
Operating conditions
Temperature + 15° C to + 32° C (59° F to 90° F)
Humidity 10 -85%
Maximum altitude 4300 m (14,000 ft)
Placement First option: Operate the monitor on a level surface, free of vibrations
Second option: Hold the monitor in your hand, so that it is roughly horizontal
Measuring range INR 0.8 -8.0
Interface USB (Type B) and Bluetooth
Power Battery -Four 1.5v AAA alkali-manganese batteries
# of tests per set of batteries
Up to 60 tests or 1 year
Size 145 x 75 x 30 mm
Weight 135 g (without batteries)
Memory 400 test results
Auto power off Auto-off after 2 minutes of inactivity
Sample material
Sample type Fresh capillary whole blood
Sample size ≥ 8 μl
Interferences Refer to the test-strip package insert
Test strips
ISI Approx. 1.0
Sensitivity to heparin Not at therapeutic levels, up to 0.8 I.U/ml for UFH and to 2 anti-Xa U/ml for LMWH
Quality control On each strip, through the same channel as the blood passes
Stability 21 months from production (+ 2° C to + 30° C)
Display
Colour Display of target range
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Contact us

Do you have questions about our products or services? We’re here to help. Contact a Roche representative in your region.

*Do not use the meter at an altitude higher than 14,000 feet (4,300 meters).

References

  1. Sharma, P., Scotland, G., Cruickshank, M., Tassie, E., Fraser, C., et al. (2015). Is self-monitoring an effective option for people receiving long-term vitamin K antagonist therapy? A systematic review and economic evaluation. BMJ Open 5:e007758
  2. Gallagher,A.M., Setakis, E., Plumb, J.M., Clemens, A., van Staa, T.P. (2011). Risks of stroke and mortality associated with suboptimal anticoagulation in atrial fibrillation patients. Thromb Haemost 106, 968–977

  3. Wan, Y., Heneghan, C., Perera, R., Roberts, N., Hollowell, J., et al. (2008). Anticoagulation control and prediction of adverse events in patients with atrial fibrillation: a systematic review. Circ Cardiovasc Qual Outcomes 1, 84–91
  4. Ward A, Tompson A, Fitzmaurice D, Sutton S, PereraR., et al. (2015). Cohort study of Anticoagulation Self-Monitoring (CASM): a prospective study of its effectiveness in the community. Br J Gen Pract. 65(636):e428-43
  5. Heneghan C., Ward A., Perera R., et al. (2012). Self-monitoring of oral anticoagulation:systematic review and meta-analysis of individual patient data. Lancet 379:322-334
  6. Bereznicki, L.R.E., Jackson, S.L., Peterson, G.M. (2013). Supervised patient self-testing of warfarin therapy using an online system. J Med Internet Res 15, e138
  7. Christensen, H., Lauterlein, J.-J., Sørensen, P.D., Petersen, E.R.B., Madsen, et al. (2011). Home management of oral anticoagulation via telemedicine versus conventional hospital-based treatment. Telemed J E-Health Off J Am Telemed Assoc 17, 169–17
  8. Bussey, H.I., Bussey M., Bussey-Smith K.L., Frei, C.R. (2013). Evaluation of warfarin management with international normalized ratio self-testing and online remote monitoring and management plus low-dose vitamin k with genomic considerations: a pilot study. Pharmacotherapy 33, 1136–1146
  9. Heneghan, C., Ward, A., Perera, R., Bankhead, C., Fuller, A., et al. (2012). Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data. Lancet 379, 322–33
  10. Heneghan, C., Alonso-Coello, P., Garcia-Alamino, J.M., Perera, R., Meats, E., Glasziou, P. (2006). Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet 367, 404–411
  11. Matchar, D.B., Jacobson, A., Dolor, R., Edson, R., Uyeda, L., et al. (2010). Effect of home testing of international normalized ratio on clinical events. N Engl J Med 363, 1608–1620
  12. Salvador, C.H., Ruiz-Sanchez, A., González de Mingo, M.A., Carmona Rodríguez, M., Carrasco, et al. (2008). Evaluation of a telemedicine based service for the follow-up and monitoring of patients treated with oral anticoagulant therapy. EEE Trans Inf Technol Biomed 12, 696–706
  13. Gardiner, C., Williams, K., Mackie, I.J., Machin, S.J., Cohen, H. (2005). Patient self-testing is a reliable and acceptable alternative to laboratory INR monitoring. Br J Haematol 128, 242–247