Gluten'Alarm® is a CE-marked and clinically validated home test for celiac disease screening. The test detects anti-tissue transglutaminase (tTG) IgA antibodies in finger blood, a key marker of gluten-triggered autoimmune reaction. With a detection limit of 10 U/ml, an analysis time of 15 minutes and a stated accuracy of over 96.7%, it provides a quick and practical first step for people with suspected celiac disease, familial risk or persistent gastrointestinal symptoms.

Compared to general tests for gluten intolerance, this is a targeted immunological rapid test that looks for anti-tTG IgA, one of the most important markers used in first-line screening for suspected celiac disease. The test must be used while eating a normal gluten-containing diet, as a gluten-free diet can give a false negative result. A positive test does not replace a medical diagnosis, but provides a clear basis for further assessment by a doctor.

• Detects anti-tTG IgA antibodies in one drop of finger blood
• Gives an answer in 15 minutes with a clear positive, negative or invalid reading
• Detection limit of 10 U/ml for early screening for suspected celiac disease
• CE-IVD approved and manufactured under the ISO 13485 standard
• Claimed accuracy above 96.7% with 95% CI 91.4 to 99.2%
• Practical home use for symptoms such as diarrhoea, bloating, abdominal pain, fatigue, anemia or weight loss

Gluten'Alarm® can be particularly relevant for adults and children with recurrent digestive complaints, unexplained iron deficiency, osteoporosis, low energy or a family history of celiac disease. In practice, the test can be used when you want a quick clarification before a doctor's appointment, for symptoms that come on after a normal diet of wheat, barley or rye, or when several members of the family want screening. In contrast to waiting for a laboratory appointment, you can get an initial indication at home, but the result must always be interpreted in a medical context.

The test is an immunochromatographic lateral flow test that uses anti-human IgA conjugate and tTG antigen on membrane for specific binding. For correct use, the test bag is opened immediately before testing, the fingertip is disinfected, and the pipette is filled to the mark without squeezing the finger hard. The blood is dripped into the test field, followed by 4 drops of diluent at 2 to 3 second intervals. The result is read after 15 minutes, and not after 20 minutes. Two pink lines at T and C mean a positive result, only a C line means a negative, and a missing C line means an invalid test. The color intensity is not decisive as long as the lines are homogeneous.

An important caveat is that people with IgA deficiency can get a false negative result even with actual celiac disease. This means that a negative test does not always rule out disease, especially in the case of persistent symptoms or if you already eat gluten-free. If the result is positive, you should contact a doctor for confirmatory blood tests and any further investigation, such as total IgA assessment and biopsy where relevant. Stored at 4 to 30°C, has a shelf life of 24 months and is designed as an IVD diagnostic tool, not as a treatment or dietary supplement.