Coagulation Testing with the CoaguChek® Point-of-Care Systems

PROBLEM AND SOLUTION

Millions of people worldwide take Vitamin-K-Antagonists (VKA) for conditions such as atrial fibrillation, mechanical heart valve replacement or due to a high risk of thromboembolism. Vitamin-K-Antagonists are oral anticoagulants, also known with the commercial names, such as Marcumar and Warfarin. These drugs are used to prevent the development of blood clots. To best monitor the efficacy of VKAs, the prothrombin time PT (INR) needs to be frequently measured.

The CoaguChek^® product family (see Figure 1) is designed for the determination of prothrombin time (PT) and activated partial thromboplastin time (aPTT, only with CoaguChek® Pro II system) in typical Point-of-Care settings, such as hospital point of care, alternate site testing (ambulatory care), and patient self-testing (home).

Since 1993, CoaguChek^® systems from Roche have set the standard in Point-of-Care INR testing for patients on oral anticoagulant therapy–giving clinicians confidence in making critical treatment decisions. The CoaguChek^® XS system and its successor CoaguChek^® INRange system are used for patient self-testing (lay use), the CoaguChek^® XS Plus system, the CoaguChek^® XS Pro system, and the CoaguChek^® Pro II system are designed for professional testing in physician office labs or hospitals (see Figure 2).

From now on, we will focus on the CoaguChek^® INRange system as it is the new standard of care for patients taking VKA / oral anticoagulation therapy as it enables patients to self-test their PT/INR at home or wherever they happen to be. It is suitable for properly selected and appropriately trained VKA patients and their caregivers.

17116_inSSIght_Roche - Coagucheck - Figure 1.png

Figure 1

17116_inSSIght_Roche - Coagucheck - Figure 2.png

Figure 2

171116_inSSIght_Roche - Coagucheck - Figure 3a.jpg

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

The CoaguChek^® INRange system is:

Simple and fast

It only takes a few easy steps and one minute to get your INR result
Side- or top-dosing of the blood drop on the strips reduces the risk of incorrect application
You can test yourself anytime as strips can be stored at room temperature

Safe and precise

Automatic check of the integrity of the strips (directly in the measuring channel) and instrument’s functionality
Lab-equivalent accuracy and precision²

Small and convenient

Connect your meter using Bluetooth or USB to quickly and easily send results to your healthcare professional
The CoaguChek^® INRange system offers more information than just your PT/INR result. With trending reports, comments and color coded graphs, you can quickly see your results, and how it relates to recent activity

Improved patient outcomes (see Figure 5)

Frequent testing leads to fewer life threatening events^{3, 4}, and increases your quality of life⁵.

Figure 4

17116_inSSIght_Roche - Coagucheck - Figure 5.png

Figure 5

Benefits for Patients, Healthcare Professionals and Healthcare Systems

Patients: Being able to accurately monitor their coagulation status anywhere, yet remaining connected to a healthcare professional means convenience, freedom and peace of mind for people taking anticoagulants. Patients are also more likely to become better informed and knowledgeable about their PT/INR levels and treatment through regular testing.
Healthcare professionals: Healthcare professionals can be confident that results are as reliable as from a laboratory. Detailed data patterns and trend reports can help to optimize treatment decisions in near real-time.
Healthcare systems: Frequent monitoring helps reduce the risk of complications⁶, helping improve patients’ quality of life and health outcomes.

Economic Impact

Millions of people worldwide are taking Vitamin-K-Antagonists (VKAs) for a variety of indications or conditions, such as atrial fibrillation (AF), deep vein thrombosis (DVT), pulmonary embolism (PE), and the presence of a mechanical heart valve (MHV)
To best monitor the efficacy of VKAs, the prothrombin time PT (INR) needs to be frequently measured
It has been demonstrated that 50–60%⁷ of patients can be expected to 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. 1 Patients who spend a high proportion of time (> 70%) in the therapeutic range achieve better clinical outcomes^{8, 9}
The Roche CoaguChek^® INRange system with Bluetooth technology sets a new standard of care in coagulation monitoring by enabling healthcare professionals to remotely monitor patient INR data in near-real time, while reducing visits to the lab.

Cooperation / Funding

In-house development without external funding.

Showcase of Smart System and pictures provided by

Roche Diagnostics Deutschland GmbH
Sandhofer Strasse 116; D 68305 Mannheim; Telefon +49 621 759 0; Telefax +49 621 759 2890
Sitz der Gesellschaft: Mannheim - Registergericht: AG Mannheim HRB 708167 - Geschäftsführung: Dr. Thomas Schinecker - Aufsichtsratsvorsitzender: Dr. Severin Schwan

https://www.roche.de/diagnostics/index.html

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.

---------------------

	Construction and Civil Engineering
	Safety, Security & Reliability
	Communications
	Energy
	Home & Entertainment
	Manufacturing & Factory Automation
	Aerospace
	Transport & Mobility
	Agriculture, fisheries, food & beverage
	Clothing and Textiles
	Health & Well-being
	The Environment