Rapid self-test for the detection of anti-tissue transglutaminase IgA antibodies associated with Gluten intolerance and, therefore, celiac disease in blood.

Celiac 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% people worldwide. Typical symptoms include chronic diarrhea, abdominal pain, gas, weight loss but also anaemia, osteoporosis, extreme fatigue and even delayed growth in case children are affected. Currently, the only treatment for Celiac disease, after being diagnosed, is a strict life long gluten-free diet. Currently, highly effective whole blood tests are the first line screening method to detect the Celiac disease. They are mainly based on the detection of anti tissue-transglutaminase (t-TG) IgA type antibodies.

Who is the test for?

For individuals seeking to determine the presence of anti-t-TG IgA type antibodies in blood.

How to use

  1. Prepare the test device, the pipette and the diluent dropper vial. Take them out from the protective pouch (tear at the notch. Remove the screw cap of the diluent dropper vial and leave it nearby).
  2. Clean the tip of the middle finger or ring finger with cotton wool moistened with alcohol. Press the lancet firmly against the side of the previously cleaned finger and press the release button.
  3. Without pressing the bulb, put in contact the plastic pipette with the blood sample. The whole blood migrates into the pipette through capillarity to the line indicated on the pipette.
  4. Dispense the blood into the sample well of the cassette, pressing down on the bulb of the pipette. Wait 30-40 seconds for blood absorption. Unscrew the blue cap from the dropper bottle, keeping the white cap secure. Add 4 drops of diluent to the well, spacing each drop 2-3 seconds apart. Read the result after 15 minutes. Do not interpretafter 20 minutes.

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Results and recommendations




  The test is positive
Two coloured lines appear in the window under the marks T (Test) and C (Control). The colour intensity of the T line may be clearer than the intensity of the C line. This result means that blood sample contains anti-t-TG IgA type antibodies and that you should consult a doctor.
 Test is negative
Only one coloured line appears under the mark C (Control). This result means that no anti-t-TG IgA type antibodies are detected in the blood sample.
 Invalid result
No line appears under the mark C. In this case, it is not possible to interpret the test, which must be considered as invalid. It is recommended to repeat the test with another GLUTEN’ALARM® test with a new blood sample.

Questions and answers

How does GLUTEN’ALARM® work?
When gluten intolerance is present, there is a production of IgA type specificantibodies directed against t-TG. The GLUTEN’ALARM® test is detectingthe anti-t-TG IgA antibodies in whole blood samples. A unique combinationof anti-human IgA dye conjugate and t-TG membrane antigen allows thespecific detection of these antibodies. When present at a minimum concentration of 10 U/mL (determined againstsamples reference panels), a pink coloured band will appear under the Tmark and will show evidences of gluten intolerance. Another pink band willalways appear under the C mark indicating that the test performed well.
GLUTEN’ALARM® test should be performed in case of gluten intolerancesymptoms or in the case members of the family are already showingthis problem. This disease is indeed occurring in genetically predisposedindividuals. The test should be performed while being on regular diet (notgluten free diet) to make the result valid.
The results are accurate as long as the instructions are carefully respected. Nevertheless, the result can be incorrect if GLUTEN’ALARM® test gets wetbefore test performing or if the quantity of blood dispensed in the samplewell is not correct. The plastic pipette provided in the box makes sure thecollected blood volume is correct.
The colour and intensity of the lines have no importance for resultinterpretation. The lines should only be homogeneous and complete.The test should be considered as positive regardless of the colour intensityof the test line (T), even weak.
When this line appears, it only means that the test has been performed well.
No. The result should be read within 15 minutes after adding the diluent. The result is reliable up to 20 minutes.
If the result is positive, it means that anti-t-TG IgA type antibodies arepresent in blood and that you should consult a doctor to show thetest results. Then, the doctor will decide whether additional investigationshould be performed.
If the result is negative, it means that the test could not detect anti-t-TG IgAtype antibodies in blood sample. In limited cases, IgAdeficiency may also lead to false negative results. Meanwhile it isrecommended to consult a doctor if symptoms persist

The GLUTEN’ALARM® test is accurate. Evaluation reports show an overall agreement higher than 96,7% [91,4 – 99,2**] with reference methods. Although this test is reliable, false positive or false negative results could be obtained.

** CI 95%: 95% Confidence Interval