Check4® Gluten Intolerance

Check4® Gluten Intolerance (150084AG) is a quick, accurate and easy-to-use self-test for the detection of gluten intolerance and coeliac disease. Quick, accurate and easy-to-use self-test that can performed in the comfort of your own home.

Description

Quick, accurate and easy-to-use self-test that can performed in the comfort of your own home.

Coeliac disease is a long-term autoimmune disorder affecting the small intestine that can occur in genetically predisposed people. It is caused by intolerance to the ingestion of gluten which are various proteins found in wheat, barley and rye. It is estimated to affect 1% of people worldwide. Typical symptoms include chronic diarrhoea, abdominal pain, gas, weight loss, anaemia, osteoporosis, extreme fatigue and even delayed growth in children.

Presently, the only treatment for Coeliac disease, after being diagnosed, is a strict lifelong gluten-free diet. Highly effective whole blood tests are the first point of screening method to detect Coeliac disease. These tests are mainly based on the detection of anti tissue- transglutaminase (t-TG) IgA type antibodies. Check4® Gluten Intolerance is a highly specific immunological rapid test for the detection of anti t-TG IgA type antibodies in finger prick whole blood samples.

The box contains the material necessary to perform a test:

  • 1 sealed aluminium pouch containing: 1 test device, 1 plastic pipette and 1 desiccant bag.
  • 1 sterile lancet for blood sampling.
  • 1 dropper bottle containing 1 ml of diluent.
  • 1 instruction leaflet.

All our Check4® range of self-test products are:

  • CE-Marked for home self-test use
  • Made and Evaluated in France
  • Easy-to-use and easy to read results
  • Accurate and trust worthy
  • Quick with results in a matter of minutes

Product Specification

Specification Type Specification Value
Product Range Self-Tests
Product Code 150084AG
Product Name Check4® Gluten Intolerance
Product Category Health Condition Tests
Product Analyte t-TG
Product Size 1 x 1 Test
Product Storage 2°C to 30°C
How does the Check4® Gluten Intolerance test work?

When gluten intolerance is present, there is a production of IgA type specific antibodies directed against t-TG. The Check4® Gluten Intolerance test allows the detection of these specific antibodies and therefore showing evidences of gluten intolerance.

The sensitivity of the Check4® Gluten Intolerance test is 10U/mL.

When should the Check4® Gluten Intolerance test be used?

The Check4® Gluten Intolerance test should be performed in case of gluten intolerance symptoms or in the case members of the family are already showing this problem. This disease is indeed occurring in genetically predisposed individuals.

The test should be performed while being on regular diet (not Gluten free diet) to make the result valid.

Can the result be incorrect?

The results are accurate as far as the instructions are carefully respected. Nevertheless, the result can be incorrect if the Check4® Gluten Intolerance test gets wet before test performing or if the quantity of blood dispensed in the sample well is not sufficient. The plastic pipette provided in the box allows making sure the collected blood volume is correct.

How do you interpret the test if the colour and the intensity of the lines are different?

The colour and intensity of the lines have no importance for result interpretation. The lines should only be homogeneous and clearly visible. The test should be considered as positive whatever the colour intensity of the test line (T) is.

What is the line that appears under the mark C (Control) for?

When this line appears, it only means that the test was performing well.

If I read the result after 20 minutes, will the result be reliable?

No. The result should be read within 15 minutes after adding the diluent. The result is reliable up to 20 minutes.

What do I have to do if the result is positive?

If the result is positive, it means that anti-t-TG IgA type antibodies are present in blood and that you should consult a doctor to show the test results. Then, the doctor will decide whether additional investigation should be performed.

What do I have to do if the result is negative?

If the result is negative, it means that the test could not detect anti-t-TG IgA type antibodies in blood sample. In limited cases, IgA deficiency may also lead to false negative results. Meanwhile it is recommended to consult a doctor if symptoms persist.

How accurate is the Check4® Gluten Intolerance test?

The Check4® Gluten Intolerance test is accurate. Evaluation reports show an overall agreement of at least 97% with reference methods. Although this test is reliable, false positive or false negative results could be obtained.

Where can I find out more information or get further assistance on coeliac disease and gluten intolerance?

For more information on coeliac disease and gluten intolerance you can visit the below:

  • https://www.nhs.uk/conditions/coeliac-disease/
  • https://www.coeliac.org.uk/
  • https://gutscharity.org.uk/