Coagulation Testing with the CoaguChek® Point-of-Care Systems
PROBLEM AND SOLUTION
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Figure 1 Figure 2 |
Figure 3a and 3b |
The CoaguChek® INRange system set consists of the instrument, disposable test strips, control materials and a lancing system (see Figure 3a and 3b). Instead of detecting the clot by mechanical or optical methods, the CoaguChek® INRange system monitors the activity of thrombin, the final protease for both plasmatic coagulation pathways. These measured INR-values are comparable to laboratory INR-values1. Furthermore, the system offers information such as trending reports, comments and color coded graphs, via with patients can quickly see their results. The meter enables patients to track their time in range by graphically displaying how many times they have been within, above or below their target therapeutic range (see Figure 4). Up to six comments with each result can be entered which help the patients to remember what is happening in their life that may have affected the results. Furthermore, reminders can be set directly on the meter for when to test or take medication. The PT test strip contains two reagents in dried form: Human recombinant Tissue Factor, also known as thromboplastin to start the extrinsic coagulation cascade and a peptide substrate Electrozym to generate the electrochemical detection signal. When the patient blood reaches the reagent zone on the test strip, FVIII from the sample binds to tissue factor and starts the coagulation process until the formation of thrombin. Thrombin reacts with the Electrozym substrate, resulting in the release of Phenylenediamine. Phenylenediamine is further oxidized at the working electrode, resulting in a current. The time between the wetting of the reagents with sample and the raise in current, due to Phenylenediamine formation is measured and converted by calibration to INR values. The CoaguChek® Softclix lancing system and matching lancets allow virtually pain-free blood sampling from your fingertip. It is handy, hygienic and safe (thanks to minimal post-test bleeding). It delivers precisely the amount of blood required without any need for venous puncture. |
MNBS/SSI Advantages
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Benefits for Patients, Healthcare Professionals and Healthcare Systems
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Economic Impact
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Cooperation / FundingIn-house development without external funding. Showcase of Smart System and pictures provided byRoche Diagnostics Deutschland GmbH
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References:
- [1] Leichsenring, I. et al. (2005). AMHP: Results of master lot calibration of a new coagulation monitoring system for patient self-testing. J Thromb Haemost. 3, (SUPPL 1):P0884.
- [2] Leichsenring, I. et al. (2005). AMHP: Results of master lot calibration of a new coagulation monitoring system for patient self-testing. J Thromb Haemost. 3, (SUPPL 1):P0884.
- [3] Heneghan, C. et al. (2012). Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data. Lancet 379 (9813), 322-334.
- [4] Koertke, H., Koerfer, R.(2001). International normalized ratio self-management after mechanical heart calce replacement: is an early start advantageous? Ann Thorac Surg 72, 44-48.
- [5] Bereznicki, L., et al. (2013). Supervised patient self-testing of warfarin therapy using an online system. J Med Internet Res 15, e138.
- [6] Gallagher, A.M., et al. (2011). Risks of stroke and mortality associated with suboptimal anticoagulation in atrial fibrillation patients. Thromb Haemost 106, 968–977.
- [7] 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.
- [8] Gallagher, A.M., et al. (2011). Risks of stroke and mortality associated with suboptimal anticoagulation in atrial fibrillation patients. Thromb Haemost 106, 968–977.
- [9] Wan, Y., et al. (2008). Anticoagulation control and prediction of adverse events in patients withatrial fibrillation: a systematic review. Circ Cardiovasc Qual Outcomes 1, 84–91.
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