Gluten'Alarm® - Home test for celiac disease (anti-tTG IgA antibodies)
Gluten'Alarm® is a CE-marked, clinically validated rapid test that allows you to detect anti-tissue transglutaminase (tTG) IgA antibodies in the blood - one of the most important markers for gluten intolerance and celiac disease. Celiac disease affects around 1% of the population and occurs in genetically predisposed people when they consume gluten from wheat, barley and rye. Symptoms can be chronic diarrhoea, abdominal pain, bloating, gas, weight loss, anaemia, osteoporosis, fatigue and, in children, delayed growth. The test only requires one drop of blood from the finger and gives an answer in 15 minutes. For a valid result, the test must be performed while eating a normal gluten-containing diet.

Brief description
Gluten'Alarm® is a simple self-test that detects anti-tTG IgA antibodies (>10 U/ml) used in screening for celiac disease. A positive result requires medical follow-up. Accuracy >96.7%, CE-IVD approved and used by healthcare professionals in Europe. 🩸🌾

Health effects
Gluten'Alarm® is a diagnostic tool that provides insight into immune reactions to gluten and can reveal the basis for symptoms related to malabsorption and small intestinal inflammation.
• Early detection of gluten intolerance: Identifies antibodies that are normally produced in celiac disease.
• Support for familial risk: Useful for genetically predisposed people who want early screening.
• Follow-up for stomach and intestinal symptoms: Provides a basis for further testing and assessment by a doctor.

No EFSA-approved health claims apply to this product.

Top 2 main functions or health effects
• Detection of anti-tTG IgA antibodies: The test uses specific IgA conjugate and tTG antigen, so that even low levels of antibodies can be identified early.
• First-line screening for suspected celiac disease: Recommended by gastroenterology guidelines before further investigation (blood tests and possibly biopsy).

A surprising or lesser-known health effect
People with IgA deficiency (about 1 in 500) may have a false negative test, even though they actually have celiac disease. This emphasizes the importance of doctors assessing total IgA for correct diagnosis.

Technical details and specifications
Gluten'Alarm® is an immunochromatographic rapid test (lateral flow) that uses anti-human IgA dye conjugate and tTG membrane antigen for specific binding of antibodies. Minimum detection limit: 10 U/ml. Accuracy: >96.7% (95% CI: 91.4–99.2%). Storage: 4–30 °C. Shelf life: 24 months. Certification: CE-IVD, ISO 13485.

Grant facts
Not applicable - this is a diagnostic test tool, not a dietary supplement.

Ingredients list
Not relevant. The test contains immunological reagents (anti-IgA, tTG antigen) and buffer solution.

Recommended use

1. Open the test bag and prepare the test cassette, pipette and diluent.

2. Disinfect your fingertip and use the lancet.

3. Hold the pipette against the drop of blood without squeezing - fill to the mark.

4. Drip the blood into the test field and wait 30-40 seconds.

5. Add 4 drops of diluent at 2-3 second intervals.

6. Read the result after 15 minutes (not after 20 minutes).

The test must be carried out while you are eating food containing gluten.

Result interpretation
• Positive: Two pink lines (T + C) → anti-tTG IgA detected, contact doctor.
• Negative: C line only → no antibodies detected.
• Invalid: No C-line → test must be repeated.

The color intensity has no meaning as long as the lines are homogeneous.

Questions and answers
How does the test work? It identifies IgA antibodies against tTG, which are formed in a gluten-triggered autoimmune reaction.
When should the test be taken? In case of symptoms or family risk, and always while eating gluten.
Could the result be wrong? Yes, in case of IgA deficiency, incorrect execution or if the test is used while following a gluten-free diet.
What do I do if I test positive? See a doctor for verifying blood tests and biopsy assessment.
What about a negative test? Consult a doctor if symptoms persist.

Reservation
Gluten'Alarm® is a medical diagnostic tool (IVD) for screening. A positive test always requires medical assessment. A negative test does not rule out celiac disease, especially with IgA deficiency or a gluten-free diet. Pregnant, breastfeeding and people with medical conditions should consult a doctor before use. Keep out of the reach of children.

Freedom of expression and right to information
Uno Vita shares publicly available research in line with the right to freedom of expression as formulated in the UN Declaration of Human Rights Article 19, ICCPR Article 19, the Constitution §100 and the US First Amendment.

Scientific references

1. Lebwohl B, et al. Semin Immunopathol. 2021.

2. Gujral N, et al. Dig Dis Sci. 2012.

3. Rubio-Tapia A, et al. Am J Gastroenterol. 2013.

4. Caio G, et al. BMC Med. 2019.

5. Singh P, et al. Clin Gastroenterol Hepatol. 2018.

6. Swiss Point of Care Validation Report GLUTEN'ALARM® 2023.

7. FHI – Celiac disease in Norway 2025.

8. Ludvigsson JF, et al. Gut. 2013.

9. Hill ID, et al. J Pediatr Gastroenterol Nutr. 2016.

10. Al-Toma A, et al. UNREGISTERED 2019.

11. Volta U, et al. You Live Dis. 2010.

12. Giersiepen K, et al. Cochrane Review. 2012.

13. Lewis NR, et al. Aliment Pharmacol Ther. 2010.

14. Halmos EP, et al. Gastroenterology. 2014.

15. Catassi C, et al. Nutrients. 2015.

16. Sapone A, et al. BMC Med. 2012.

17. Fasano A, Catassi C. N Engl J Med. 2012.

18. Green PHR, et al. Am J Gastroenterol. 2007.

19. Rostami-Nejad M, et al. Autoimmune Rev. 2020.

20. Abadie V, et al. N Engl J Med. 2020.

21. EFSA Journal. 2011