Roche today confirms the safety and accuracy of CoaguChek PT/INR devices for use by healthcare professionals at the point of care and by patients who test at home.
Point-of-care and patient self-testing (PST) are growing standards of care for patients requiring regular PT/INR tests for warfarin therapy. These convenient forms of testing help patients adhere to their prescribed testing frequency and healthcare professionals make more timely treatment decisions. Patients who adhere to their testing schedule spend more time in their therapeutic range, which results in lower incidence of stroke1 or bleeding.2 Additionally, 50–60% of patients remain in their target range if monitoring of INR occurs monthly, 77–85% if monitored weekly and up to 92% if monitored every three days.3 Patients who spend a high proportion of time (> 70%) in therapeutic range achieve better clinical outcomes.4,5
“Patients and caregivers are often pleased to learn that they can test at home rather than have blood drawn in a lab. In appropriately selected patients, CoaguChek PT/INR testing provides precise, accurate results, time savings and convenience” said Dr. Alan Wright, Chief Medical Officer, Roche Diagnostics Corporation.
With PT/INR testing and associated devices in the news, it’s important to note the following:
- Roche is committed to continuing to support patients, caregivers and healthcare professionals by supplying CoaguChek PT/ INR meters. Roche is extremely confident in the quality, accuracy, safety and value of CoaguChek PT/INR meters;
- The CoaguChek XS system is 97% accurate compared to lab results6;
- CoaguChek meters have been offered in the U.S. for more than 20 years and there are more than one million CoaguChek XS devices in use around the world;
- Over 250,000 CoaguChek XS PT test strips are used globally per day; and
- Nine of the top 10 U.S. integrated health networks (IHNs) choose CoaguChek technology7.
View the full press release here.
1. Heneghan C, Ward A, Perera R, et al. Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data. Lancet. 2012;379:322-334.
2. 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.
3. Khan TI, Kamali F, Kesteven P, Avery P, Wynne H. The value of education and self-monitoring in the management of warfarin therapy in older patients with unstable control of anticoagulation. Br J Haematol. 2004;126(4):557-654.
4. 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.
5. Wan, Y., Heneghan, C., Perera, R., Roberts, N., Hollowell, J., Glasziou, P. et al. (2008). Anticoagulation control and prediction of adverse events in patients withatrial fibrillation: a systematic review. Circ Cardiovasc Qual Outcomes 1, 84–91.
6. 97% correlation with lab results using Dade Innovin reagent. See package insert for more information. CoaguChek XS PT Test [package insert 05967694001(05)]. Indianapolis, Ind.: Roche Diagnostics; 2016.
7. GHX Market Intelligence. Data on file. Roche Diagnostics.