Case Finding for Coeliac Disease Using a Point of Care Test in a Pharmacy Setting
Condition: Coeliac Disease
MeSH terms: Celiac Disease
Study type: Interventional

Summary: 
      This study aims to assess whether it is feasible to use a point of care test to increase the
      detection of coeliac disease in a pharmacy setting.
    

Detailed description: 
      Coeliac disease (CD) is an autoimmune condition characterised by mucosal damage of the small
      intestine by dietary gluten. CD affects 1 in 100 people. However, patients do not always have
      symptoms, resulting in 5 undiagnosed patients to every known case of CD. Undiagnosed CD can
      lead to complications such as vitamin and mineral deficiencies, osteoporosis and small bowel
      lymphoma, as well as impairing quality of life.

      Currently, patients are diagnosed with a conventional blood test for coeliac antibodies
      (anti-TTG) as a first line test. Simtomax®, a new coeliac point of care test (POCT), has
      become available. It is a finger prick test that provides results of a coeliac antibody,
      deaminated gliadin peptide, within 10 minutes. Studies showed that Simtomax is as accurate as
      anti-TTG, with a 92.7% chance of detecting CD and 98.7% chance of ruling out CD.

      This study aims to assess whether the POCT can increase the detection of adult coeliac
      disease when used in a pharmacy setting. A feasibility study using a case-finding approach
      will be conducted at 5 pharmacies in Sheffield over 20 months. It will be funded by Professor
      Sanders' research funds.

      Customers who enter the pharmacies will be approached by the principal investigator (PI).
      Eligible participants (those with symptoms suggestive of or risk factors for CD) will be
      consented for the POCT by the PI. The POCT will be carried out at the pharmacies. Any
      participant with a positive test will be advised to see his GP to be referred for a
      gastroscopy at the Royal Hallamshire Hospital to confirm the diagnosis. Once diagnosed, the
      participant will follow the standard management pathway for any patients with CD.

      Results of the study will be compared to the established prevalence of CD of 1%, to assess
      whether using POCT in a pharmacy setting can increase the detection of adult CD.
    

Intervention name(s): Simtomax
Intervention type(s): Device
Intervention description(s): Patients will undertake a finger prick point of care test, Simtomax, at the pharmacy. A sample of 25 μl of capillary venous blood is required which can be obtained through a simple finger prick technique. The sample is then applied to the test device, followed by the application of 5 drops of the provided buffer solution. The result can be read after 10 minutes. Positive results are indicated by the presence of a solid red line, with a single line for a combined IgA and IgG DGP positivity, and a single line for the presence of total IgA. An in-built control line ensures a correctly functioning test.
Other intervention name(s): Point of care test
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Point of care test; Diagnosis; Case finding