Gluten allergy self-test: GlutenCHECK

Gluten intolerance (Coeliac disease), known as  sprue in adults, is an autoimmune disorder of the small intestine, when the immune system attacks the body‘s own tissues. The common symptoms of gluten intolerance include bloating and diarrhea, caused by a reaction to a gluten protein found in many foods. The following symptoms could be also a sign of gluten intolerance: weight loss, malnutrition and skin disorders.

GlutenCHECK© is intended as an aid in the detection of gluten intolerance. GlutenCHECK© as an immunochromatographic rapid test detects the presence of anti-tTG IgA antibodies in whole blood. If the blood sample contains anti-tTG IgA antibodies, these will bind with the colloidal gold labelled anti-hIgA antibodies and the tTG (derived from the lysis of red blood cells in the dilution buffer). tTG will then bind the complex to the stationary protein line (test line) forming a visible, red line.

GlutenCHECK© detects tTG-IgA values greater than 5 U/mL with a positive test result.

The test has also a control system with a control line. Since anti-tTG IgA-antibody levels normalizes slowly when on a strict gluten-free diet, the test should not be used to detect gluten intolerance after switching to a gluten-free diet.

Performance upon comparing with a reference method:

• Sensitivity: 98.0%
• Specificity: 96.7%
• Accuracy: 98.0%
• Trueness: 97.5%

The test result must be confirmed by a physician with further recommendation to maintain a gluten-free diet.

An explanation of how to read and interpret the test result is given in this instruction pamphlet. Therefore, it is important to fully understand the entire instruction pamphlet before performing the test.

The package contains:

• 1 testcassette in sealed pouch
• 1 transfer pipette
• 1 glass capillary in protective container
• 1 buffer vial
• 1 safety lancet
• 1 alcohol swab

Also needed, not provided in the package:

• 1 timer