IBDoc® vs SmarTest Calprotectin

IBDoc® is an in vitro diagnostic immunoassay for the quantitative determination of fecal calprotectin in human stool. It is intended as an aid to the assessment of inflammation of the intestinal mucosa for inflammatory bowel disease (e.g. Crohn’s Disease and Ulcerative Colitis) monitoring. As part of the IBDoc® calprotectin home test, the IBDoc® app allows measuring the calprotectin concentration in a stool sample using a smartphone. The app contains an easy to understand tutorial explaining the test procedure step by step from the collection of the stool sample to sample extraction and loading of the pregnancy test-like test cassette. Once the test cassette is prepared, the IBDoc® app controls the mobile device camera to take a picture of the test cassette. The optical signal of the test is analyzed with the help of a specific barcode on the test cassette. The signal is translated into a result that indicates the calprotectin concentration in the stool sample. The test information is managed on the smartphone itself and at the same time transmitted via a secure and encrypted connection to the IBDoc® Portal. The test results and connected patient information are stored securely on the IBDoc® Portal and can only be accessed by both the patient and his responsible healthcare practitioner. The IBDoc® app features include: -tutorial with schematic drawings and text explaining the test procedure step by step -A list of all test results performed by the patient -help menu with a tutorial video and support contact --------------------------------------------------- IMPORTANT NOTICE --------------------------------------------------- Please be aware that the IBDoc® app only works with an IBDoc® Account and an IBDoc® test kit. This Account has to be set up by a healthcare practitioner. Please contact your IBD doctor or IBD clinic for additional information. Please read the Instruction for Use included in the IBDoc® test kit carefully before performing the first test. The IBDoc® app has been validated for specific smartphone models to ensure accurate results, please consult the list of validated smartphones here: www.ibdoc.net/support A data connection is required. Depending on your carrier additional costs might arise. -------------------------------------------------- For IBDoc® app (BI-IBDOCAND and BI-IBDOCIOS) and IBDoc® Portal (BI-IBDOCPOR) software device: We, BÜHLMANN Laboratories AG, declare under sole responsibility that the device specified above meets the provision of the IVD Regulation (EU) 2017/746 for in vitro diagnostic medical devices, the Canadian Medical Devices Regulations SOR/98-282, and is in conformity with other relevant Union legislations, common specifications (CS) and other normative documents - CE-marked product: CE0123 - Health Canada License 98903 - In the USA, IBDoc® is available for Investigational Use Only and shall not be used for diagnostic procedures. IBDoc® and CALEX® are registered trademarks of BUHLMANN Laboratories AG in many countries.

Reliable and simple app for quantitative determination of calprotectin in stool for in vitro diagnostic use. SmarTest Calprotectin is a manually performed rapid test including a smartphone app developed for its evaluation to quantitatively detect the inflammatory marker Calprotectin in human stool. It provides assistance in the follow-up and therapy monitoring of chronic inflammatory bowel diseases (e.g. Crohn's disease or ulcerative colitis). Calprotectin is a calcium-binding protein that is produced in large quantities by specific immune cells, the neutrophil granulocytes (neutrophils), and released during inflammatory events. In inflammatory bowel diseases, neutrophils migrate into the intestinal lumen and release calprotectin, which can then be detected in the stool. However, on the basis of clinical symptoms, it is often difficult to distinguish patients with inflammatory bowel diseases (IBD) such as Crohn's disease and ulcerative colitis from patients suffering from the usual irritable bowel syndrome. With the additional determination of calprotectin in the stool, however, inflammation in the intestinal tract can be diagnosed with clinical certainty. An increased calprotectin concentration in the stool provides information about the presence of inflammation in the intestine. This non-invasive determination of calprotectin can often spare patients with common irritable bowel syndrome an unnecessary invasive colonoscopy in case of low concentrations. Since scientific studies have shown that the concentration of calprotectin in stool correlates well with histological and endoscopic findings of disease activity in patients with IBD, the calprotectin concentration in stool can also be used diagnostically to objectively document therapeutic success. Furthermore, it can be used to monitor currently asymptomatic IBD patients in order to detect and control relapse of IBD at an early stage.