BIOHIT Healthcare Ltd

Model PST11001EP04 - SmarTest Calprotectin Home test (Preventis)

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SmarTest® faecal calprotectin home test is a simple-to-use inflammatory bowel disease stool test that enables individuals with Crohn’s disease or Ulcerative colitis to monitor their disease activity at home. Patients can use the quantitative calprotectin test at home, or indeed anywhere, with minimum test preparation or disruption to their day. This in vitro bowel inflammation test measures calprotectin using gold-conjugated anti-calprotectin antibodies in a lateral flow test in conjunction with a smartphone app which quantifies and reports the result so that patients and providers can evaluate the effectiveness of treatment controlling the disease. The SmarTest app scans and analyses the faecal calprotectin test result according to the intensity of the control and test lines on the lateral flow test. The quantitative results of the test are then sent automatically to the Online Portal for the patient’s IBD clinical team to monitor remotely. The SmarTest Calprotectin Home test app also features a clinically validated disease activity questionnaire for Monitoring IBD at home (MIAH), providing a subjective approach to evaluating disease activity in conjunction with the bowel inflammation test.

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Close monitoring of inflammatory bowel disease activity promotes early identification of mucosal inflammation, enables rapid intervention, and treatment optimisation, which is associated with better long-term outcomes. Gaining control, reaching deep remission, and preventing flares, are considered priority treatment goals for IBD patients. The gold standard for assessment of mucosal inflammation is endoscopy and therefore not suitable, available or sustainable for routine monitoring of disease and so faecal calprotectin serves as a valuable objective non-invasive biomarker to monitor intestinal inflammation. Testing faecal calprotectin at home delivers immediate, actionable results, and promotes Patient initiated follow up (PIFU) for faster intervention, without the need for utilising hospital or laboratory resources.

The SmarTest faecal calprotectin home test is a self-test for calprotectin that can be easily performed by the patient in their home or by healthcare professionals in a primary care setting to monitor ulcerative colitis (UC) and Crohn’s disease (CD) activity removing the inconvenience, cost and time associated with preparing and shipping sample collection kits and patient samples, and eliminating turn-around delays. Patients can test their own faecal calprotectin – a useful inflammatory marker in stool, at prescribed intervals for regular monitoring or as needed, for example when experiencing signs of a disease flare such as abdominal pain, abnormal bowel function, change in stool consistency, frequency or urgency, or episodes of fatigue.

Preventis SmarTest is a solution to monitor inflammatory bowel disease remotely by measuring calprotectin in stool samples in combination with the SmarTest Calprotectin Home test app, which together help patients and healthcare professionals stay on top of disease activity, making treatment adjustments and optimisation quicker and simpler.

  1. Access the online portal and set up a Competence Centre

IBD clinical teams can register with the Preventis Web Portal free of charge. Once registered they can create their Competence Centre(s) within the portal. Their Competence Centre is the central hub where clinicians manage users and patients, and view test results. Patients’ faecal calprotectin results and their responses to the IBD disease activity questionnaire are automatically uploaded together to the portal. This enables clinicians to not only monitor inflammatory bowel disease markers, but also to understand the type and severity of symptoms that patient is experiencing. Having the ability to monitor patients, and become alerted to increasing or high calprotectin levels remotely, offers convenience for both the patient and the medical team.

  1. Enrol patients

Patients are enrolled in the Competence Centre where a Patient Information Sheet containing a patient-specific QR code gets automatically generated. Give this to the patient once they have been inducted into the SmarTest Calprotectin test programme, and they can simply connect their SmarTest Calprotectin app to the inflammatory bowel disease (IBD) team’s Competence Centre by scanning the QR code using their app. Once connected to the Competence Centre, all faecal calprotectin test results and disease activity questionnaire responses will be synchronised automatically with the Competence Centre, collated, and monitored. The SmarTest bowel inflammation test is simple to use for the patient and the medical monitoring team.

  1. Monitor your patients

Once a patient has been enrolled into the SmarTest Calprotectin programme, each result generated from the faecal calprotectin test and the disease activity questionnaire automatically gets sent from their smartphone to the Competence Centre. The faecal calprotectin home test results along with the responses to the IBD activity questionnaire are logged in the online web portal where the IBD team can assess and monitor them from anywhere. The Preventis SmarTest system is the perfect tool for detecting active or escalating disease in patients outside of the clinic setting, and is designed to give easily readable and actionable results that help the patient receive fast and effective medical care.

The Preventis SmarTest faecal calprotectin home test is a pocket-sized individual kit that contains everything the patient needs to check faecal calprotectin levels in the comfort of their home. This quick and easy to use bowel inflammation test takes less than twenty minutes to complete and provides fast numerical test results. Patients can store the calprotectin test kit at room temperature, so there is no need for any refrigerated storage and the test can be taken anywhere. This makes work, travel and day to day activities easier. Each test accurately checks for calprotectin in stool – a recognised and routine inflammatory bowel disease marker, with a measuring range of 31-4,000 µg/g.