First-in-class Smart Strip technology allows for convenient, safer, accurate, at-home patient testing without the need to visit a specialised clinic for an INR blood test.
Technology widely used in gaming and mobile phone accelerometers has been further refined to add a sensitivity element to the sensor. The sensor cantilever itself is one-six the thickness of a human hair and beats many times per minute in the blood sample, sensing minute changes in the viscosity of the blood as a clot starts to form.
An in-built 'memory chip', individually coded to improve accuracy, stores all the information the system needs to safely run the test in every strip. Other parameters such as calibration data, data about lot numbers/expiry date and even vendor specific information can also be stored.
The Smart Strip can be used to detect a variety of substances by measuring changes in viscosity.
If the strip is out of date or has already been used, the system will reject it before testing is initiated. Two on-board quality control sensors monitor humidity and temperature. If either of these change colour, for example when a strip is left out of its protective wrapper for too long, the meter will again reject the strip.
The micro capillary and hydrophilic top sheet combine to make this one of the easiest INR testing system on the market. The blood is drawn up the test strip by capillary action requiring only 5µL of blood to successfully run the test. The strips are individually wrapped and available in boxes of 24 and 48.
‘Chip on a strip’
Each Smart Strip has an embedded memory microchip which allows it to store calibration data, expiry date and lot number.
On board QC
Each strip has two qualitative controls to monitor the humidity and temperature the strip has been subjected to prior to use. If the strip is compromised, it will be rejected by the CoagMax® monitor.
Low blood volume
The Smart Strip INR uses only 5µL of blood, which enables use of significantly less painful lancets.
Each strip is individually wrapped with a smart humidity wafer to keep it in perfect condition prior to use.
The test strip has an alignment notch to ensure efficient use requiring only a small blood sample.
It is usually carried out in one of two ways:
To ensure people using these medications stay within the desired therapeutic range, the Prothrombin Time (PT) test was developed. This was further improved in the early 1980s and standardised to PT/INR (International Normalised Ratio). Essentially your INR result indicates how much slower your blood is clotting than normal. For example, an INR result of 2, means your blood is taking twice as long to clot as it usually would if you weren't taking oral anticoagulation therapy.
To ensure this doesn’t happen, you will be given a target INR range. In healthy people an INR of 1.1 or below is considered normal.
Today PT/INR testing is usually performed in either a hospital-based clinic or in the GP surgery and generally requires a 24-hour wait for your result and any dosage changes. To avoid potentially serious complications such as bleeding or strokes, testing must be performed regularly so dosage adjustments can be made.
The technology available for self-testing has improved greatly in recent years and result generally follow those generated by the laboratory. Dosing adjustments are still carried out by a qualified physician, but patients can often avoid unnecessary visits to see the doctor.
The CoagMax® monitor using Smart Strip technology allows you to self-test in a significantly easier and less painful manner that ever before. Taking our cues from the blood glucose testing industry, we have designed a system with the patient in mind that allows the patient to take the meter to their finger rather than having to manipulate their finger towards the meter.
*Reference: The Lancet Dec 2011 Heneghan. Ward. Perera ‘Self-monitoring of oral anticoagulation: systematic review and meta analysis of individual patient data’.
Compliance – Ability to discuss patient’s INR result with them in real time ensures you can positively reinforce any compliance issue face-to-face.
Workflow – A fingerstick test is quick to perform, providing results within 3 minutes.
Flexibility – For patients requiring testing in the community, CoagMax® is a small monitor with its own carrying case that can be taken to the patient. Test results can be easily added to the patient’s record when back at the physician’s office.
Quality control – The CoagMax® Smart Strip has built-in quality checks to ensure the strip is in premium condition for testing. Users can also run external liquid quality control and EQA samples to ensure absolute integrity of the system and results.
Accessibility – Regular Point-of-Care INR testing can improve control, reduce concerns about risk and allow a greater percentage of AF patients to be moved to Oral Anticoagulant Therapy.
Self-testing can free yourself from regular hospital/laboratory visits and give you control over your anticoagulation regime. Key questions to check suitability to self-test:
•Are you on long-term oral anticoagulation? E.g. Coumadin® (Warfarin)/Marcumar® (Phenprocoumon)
•Are you confident enough to take a greater role in your anticoagulation management?
•Would you prefer to test your own INR using a Fingerstick device or visit a clinic to have a venous blood sample taken?
If you answered yes to the above, ask your doctor about supporting a change in monitoring.
Maintaining a steady and safe INR is reliant on ensuring you take the required dosage of anticoagulant every day, at the same time.
Vitamin K – These drugs work by reducing the amount of Vitamin K your body has to make blood coagulation factors, so anything you eat with large amounts of Vitamin K will influence your anticoagulant need and may require dosage adjustment accordingly. These foods include kiwi, blueberries, broccoli, cabbage, Brussels sprouts, asparagus, cauliflower, peas, lettuce, spinach, parsley, kale, vitamins, soybeans, cashews, beef or pork liver.
Alcohol – Alcohol can affect the performance of anticoagulants. Serious problems can occur with alcohol and Coumadin (warfarin) when you drink more than 2-4 units a day or when you change your usual pattern.
Aspirin – Any product containing aspirin may lessen the ability of your blood to form clots and may harm you when you take Coumadin (Warfarin). If you take any aspirin containing medication, ask your doctor what dose is right for you.