The CALEX® Valve is an easy to use device designed by BÜHLMANN which allows precise and quantitative stool extraction to be used for calprotectin home testing. It consists of the sampling pin, the body and a valve to release a precise amount of stool extract onto the test cassette. The body is pre-filled with extraction buffer and thus delivered ready to use.
The CalApp® turns your smartphone into a test cassette reader using state of the art image processing. First the CalApp® guides the user through the test procedures step by step with an intuitive tutorial. Once the test cassette is ready, the CalApp® scans the cassette and calculates an quantitative calprotectin concentration. The CalApp® is available for iOS and Android.
The IBDoc® Portal serves as a platform for Health Care Professionals to register and manage patient information and to follow their test results over time. The Health Care Professionals are immediately notified about every new test result of one of their patients. The IBDoc® Portal is designed with the highest security standards to keep confidential information safe and serves as communication platform between patient and doctor.
After downloading and starting the CalApp® the patient logs in with his or her IBDoc® account username and password and is ready to start the test procedure. The first step is to collect a stool sample with the easy to use stool collection paper sheet included in the IBDoc® Test Kit.
After collection of the stool sample the pin of the CALEX® Valve extraction device is dipped into the sample a few times with a twisting motion so that a predefined amount of stool sticks to the grooves of the CALEX® Valve sampling pin. Then the pin is placed back into the tube through the upper funnel.
The CALEX® Valve tube is applied onto the cassette and a precise amount of extract is released by turning the throttle. After a few seconds, when the membrane strip of the cassette gets visibly soaked, the throttle is closed.
To read the result the camera is placed above the cassette, the overlay is focused and a picture is automatically taken. The image is analysed through a sophisticated image processing and a quantitative result is calculated by the CalApp®.
The result is classified as NORMAL, MODERATE, or HIGH, shown in a traffic light code and saved. All the results performed on one smartphone are saved locally and can be accessed at any time later on.
The result taken with the CalApp® is automatically transferred to the IBDoc® Portal and the patient’s doctor is immediately notified. Depending on the test result the doctor can communicate with the patients to advise on further therapeutic steps to be taken.
All components of the IBDoc® systems have been developed to measure up to the highest standards of the industry resulting in a robust and reliable test – the first of its kind. Quality is not just a statement, but part of BÜHLMANN’s daily commitment.
The IBDoc® Test Kit provides an easy to use therapy monitoring home testing system for IBD Patients – empowering the patients, connecting them with their doctors and allowing them to manage the disease as a team.
BÜHLMANN takes great care that patient information is transmitted and stored in a secure way. The IBDoc® Portal works with online-banking grade data encryption and only a patient’s treating physician has access to medical information.
Calprotectin is a heterodimeric protein also known as MRP8/14 and is abundantly present in macrophages and neutrophil granulocytes; inflammatory cells of the immune system. Calprotectin is released from these cells at the site of active inflammation and therefore elevated calprotectin levels indicate an ongoing inflammation. Calprotectin can be measured in both blood and faecal samples.
Measurement of faecal calprotectin is considered a reliable indicator of inflammation and numerous studies show that while faecal calprotectin concentrations are significantly elevated in patients with inflammatory bowel disease (IBD), patients suffering from non-organic bowel disease (IBS) do not have increased calprotectin levels. Such increased levels are shown to correlate well with both endoscopic and histological assessment of disease activity.
Around 2 million people in Europe suffer from IBD. Crohn’s Disease (CD) and Ulcerative Colitis (UC) are incurable serious chronic diseases of the intestinal tract. The symptoms are distressing, embarrassing and even debilitating. Once symptoms appear, they resemble those of other conditions of functional origin (IBS), which make it very difficult for doctors to correctly diagnose.
The clinical course of most patients with IBD is marked by periods of remission with intermittent relapses characterized by increased intestinal inflammation. Numerous published studies have looked at faecal calprotectin levels in patients during the course of the disease. The results show that calprotectin is a good predictor of relapse in patients with IBD. The treatment aim in IBD patients is of course clinical remission. Because sustained clinical remission is associated with mucosal healing in the gut and reduced rates of hospitalisation, identifying patients likely to relapse enables their clinicians to adapt the patients treatment accordingly and to ease the relapse severity.
BÜHLMANN is a fully independent, medium sized and family owned Swiss company. Founded in 1976, BÜHLMANN today has local teams in Switzerland, France, Italy, Germany, Austria, Brasil, the USA and distributors worldwide.
BÜHLMANN has become the prime calprotectin company within few years, offering the broadest range with a fully automatable, high-throughput BÜHLMANN fCAL™ ELISA and the quantitative Quantum Blue® Calprotectin rapid tests. BÜHLMANN does not only stand for calprotectin, but a selection of unique, high-quality assays for clinical routine use such as the BÜHLMANN Flow CAST® product group for Basophil Activation Testing, and the BÜHLMANN GanglioCombi™ products, the only screening ELISAs for anti-ganglioside testing. As unique as our products are our distribution fields with leading suppliers in the field of molecular diagnostics.
The Quality Management System is ISO 9001:2008 and 13485:2003 certified and the products are manufactured according to GMP standards.
*IBDoc® is not available in the US.