Test Kit Launched for Crohn’s and Ulcerative Colitis

By LabMedica International staff writers
Posted on 07 May 2015

The first in vitro diagnostic test to measure the fecal inflammation marker calprotectin at home has been launched allowing people to self-test for gastrointestinal inflammation that may including the inflammatory bowel diseases Crohn’s and ulcerative colitis.

Inflammatory bowel disease refers to chronic inflammation of all or a portion of the digestive tract. Crohn’s disease is a chronic gastrointestinal tract inflammatory condition that can affect any region of the gastrointestinal tract and ulcerative colitis is a chronic large intestinal disease.

Image: 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 (Photo courtesy of BÜHLMANN).

Calprotectin is a fecal-based biomarker that can be used to measure gastrointestinal inflammation. Scientists have found that it corresponds with gastrointestinal damage and with measurements made using endoscopy in both Crohn’s disease and ulcerative colitis. It is believed to be a better biomarker than those measured using blood tests.

BÜHLMANN Laboratories AG (Schönenbuch, Switzerland) has launched the testing kit that combines a stool extraction device called CALEX, a calprotectin test strip and IBDoc smart phone app. Individuals with these potential inflammatory bowel diseases will no longer need to bring stool samples to a clinic or laboratory for testing. Patients are able to read the test result via an image and communicate with healthcare providers using the internet, rather than going to a medical office. A web portal is available and the patient can monitor the test results continuously. The company also assures a high level of security and confidentiality is in place. The test kit is Conformité Européene (CE)-marked.

Thomas Hafen, PhD, the CEO of BÜHLMANN, said, “IBDoc is a milestone for patients, but also a milestone in the still young history of smart phone based clinical applications. Never before has such a sophisticated biologic test system been brought to patients’ homes.” Christian Reinhard, PhD, the company product manager said, “The feedback from enrolled patients so far is phenomenal. Patients are so motivated and they really like to be in charge and at the same time communicating with their nurse or physician.”

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BÜHLMANN Laboratories AG