Information about the Coeliac disease test Gluten’Alarm
The Coeliac disease test is a certified medical device for testing at home.
The test is a tTG blood test that detects the presence of specific anti-tissue transglutaminase IgA type antibodies in whole blood (IgA-tTG).
Anti-tissue transglutaminase antibodies in the blood are a clinical sign of the coeliac disease. Experts recommend IgA-tTG blood tests for initial testing of coeliac disease.1
Testing with this coeliac disease test is very easy. It is carried out in three steps:
- withdraw blood from a fingertip,
- add the blood and buffer to the testing device,
- wait 15 minutes for the result.
Individuals usually need 5-10 minutes to complete the coeliac disease test at home. Above that, there is an additional 15-minute waiting time for the result to appear.
The test is manufactured in France. It is ISO 13485 compliant and CE certified in Germany by the Notification body 04832.
The test is very accurate. The clinical performance evaluation study showed that this coeliac disease test detected the result correctly in 96,9 % cases.
The Coeliac disease test comes with the Sanotest Quality Guarantee and will be replaced to you free of charge in case you were not able to obtain the result.
Testing kit includes everything you need to perform testing for the coeliac disease at home, and it comes with easy-to-follow instructions for use.
You will receive the coeliac disease test in discreet packaging so that nobody will know what is inside the package.
Coeliac disease, gluten intolerance and non-celiac gluten sensitivity
Coeliac disease and gluten intolerance can be two different conditions, but often they have common symptoms. If coeliac disease is not the case, it might be gluten intolerance or non-celiac gluten sensitivity.
Coeliac disease is an autoimmune disorder that is induced by gluten at genetically predisposed individuals.3
Experts estimate that 1% to 2% of the world population suffers coeliac disease and can reach a 20% share in the high-risk population.4
A higher risk of developing coeliac disease have those who are related to a person with coeliac disease, especially those if the coeliac disease has someone within the family (father, mother, brother or sister).5
Gluten intolerance and Non-celiac gluten sensitivity
Individuals without the coeliac disease can still experience symptoms of coeliac disease. Experts define such state as gluten intolerance or Non-Celiac Gluten Sensitivity (NCGS).
“Non-Coeliac Gluten Sensitivity is a syndrome characterized by intestinal and extra-intestinal symptoms related to the ingestion of gluten-containing food, in subjects that are not affected by either celiac disease or wheat allergy.”6
The latest research shows that non-celiac gluten sensitivity could be present at 6% of the population (this is 6-times more common condition that coeliac disease).
Typical symptoms of NCGS are similar to those of coeliac disease and include abdominal pain, eczema or itching, headache, weight-loos, behavioural changes, fatigue, diarrhoea, anaemia, leg numbness, bone and joint pain.7
Specific diagnostic tests for non-coeliac gluten sensitivity do not exist. The NCGS is diagnosed with ruling out other conditions that might be causing symptoms, like coeliac disease and wheat allergy.
When to get tested for the coeliac disease?
Experts recommend testing for the coeliac disease, especially to individuals who experience symptoms of coeliac disease after ingestion of gluten,3 such as:
- chronic diarrhoea,
- chronic abdominal pain,
- weight loss,
- GERD (gastroesophageal reflux disease),
- iron-deficiency anaemia,
It is important to note that individuals with coeliac disease are mostly not even aware they have it. 80% to 90% of conditions are still not identified.8
By identifying the root cause of complaints, one can potentially prevent health complications that might arise due to coeliac disease or other gluten-related disorders.
A higher risk of developing coeliac disease have family members of individuals with coeliac disease.3 In such a case, it is recommended for the entire family to get tested.
There is an increased risk of developing coeliac disease also at individuals with down syndrome, type 1 diabetes, autoimmune thyroid disease.3
Benefits of testing for the coeliac disease at home
Doing this coeliac blood test at home is a convenient, time and cost-efficient approach for screening the presence of tTG antibodies that are a clinical sign of the coeliac disease.
Its unique design enables individuals with no knowledge or experience in medical self-testing to complete the analysis.
The main benefit you get by performing the coeliac disease test at home is that you get the result almost instantly (15 minutes).
You do not need to go anywhere or send your samples to a laboratory for analysis. This tTG blood test highly correlates with the results obtained in the laboratory.
How accurate is the coeliac disease test?
This coeliac disease test is very accurate. Performance evaluations studies showed that the test is 96,9 % accurate. Such accuracy means that the coeliac disease test showed the correct result in 96,9 % of cases in comparison with reference method.
European Society for Pediatric Gastroenterology, Hepatology, and Nutrition Guidelines for the Diagnosis of Coeliac Disease considers an antibody blood test for coeliac disease as reliable if it shows at least 95% agreement with the reference standard.9
The test is manufactured in France, and it is ISO1348510compliant and CE certified in Germany by Notification body 04832.
How to perform the coeliac disease test at home?
Testing with this coeliac blood test is straightforward. You only need to follow step-by-step instructions for use that come with the testing kit.
The test is a serology test. Therefore a small sample of blood from a fingertip needs to be collected. Accessories for blood collection come with the kit.
You carry out testing in three steps:
- withdraw blood from a fingertip,
- add the blood and buffer to the testing device,
- wait 15 minutes for the result.
Individuals usually need 5-10 minutes to complete the coeliac disease test. Above that, there is an additional 15-minute waiting time for the result to appear.
You should read instructions for use before you start the testing procedure. Individuals usually do not have difficulties using the test, but in case you find it difficult, we are here to help you. Contact our customer service.
The usefulness of the results obtained with the coeliac disease home test
Results obtained with this coeliac disease test are beneficial as a first step in the identification of a coeliac disease or other gluten-related disorders like non-coeliac gluten sensitivity.
Results are interpreted visually as positive, negative or invalid.
In case of a positive result: avoid food containing gluten and consult with your doctor about further steps.
In case of a negative result: monitor the symptoms of the coeliac disease. If you experience the symptoms again, it might be beneficial to perform another test. If symptoms persist, you should consult your doctor for further investigation.
Important notice: If the result of the test is negative and symptoms of the coeliac disease persist, you might be suffering from non-celiac gluten sensitivity. We advise you to consult with your doctor.
In case of an invalid result: the Sanotest Quality Guarantee applies. Please contact us.
Limitations of the coeliac disease test
With many advantages of this coeliac disease home test, there are also some limitations you should consider before ordering the test.
The test is not suitable for individuals on a gluten-free diet.
This coeliac blood test detects specific anti-tissue transglutaminase IgA type antibodies in whole blood. These antibodies are produced by the body’s immune system when an individual ingests gluten.
If you are on a gluten-free diet, your body will not produce IgA-tTG antibodies. In such a case, the result of the test will be a false negative, despite you might have a coeliac disease.
To ensure accurate results, you should perform the test while being on a regular diet (including gluten).
This test is not suitable for children under two years old.
Due to weaker sensitivity of serological tests, experts do not recommend tTG blood test for children under two years old. Other diagnostic methods should be considered.8
Please consult your doctor if your child needs to get tested.
You should not establish a diagnosis on your own and solely based on this coeliac disease test.
Although the test is highly accurate, you should not establish a diagnosis and conclusions about the treatment solely based on the result of this coeliac disease test. You should always consult your doctor for further investigation, diagnosis, and potential treatment.
The coeliac disease test is for single use and one person only.
You should never combine blood samples or reuse the coeliac disease test. Only one person should use the test. Once the analysis is complete, you cannot reuse any parts of the testing kit.
Questions and answers about the coeliac disease test
In the following are summarized questions individuals frequently ask us about the coeliac disease test. Perhaps you find the answers useful.
If you have other questions, do not hesitate to contact us. Please send us your question by email to firstname.lastname@example.org.
Can I perform the test if I am on a gluten-free diet?
Yes, you can. You should perform the test while being on a regular diet (including gluten) to ensure accurate results.
Can this test be used to test for gluten sensitivity?
Not directly. There are no specific tests for gluten sensitivity. Gluten sensitivity is diagnosed by ruling out other gluten-related conditions, like coeliac disease or wheat allergy.
In this context, the coeliac blood test is particularly beneficial, since it can help to rule out the presence of IgA-tTG antibodies that are a clinical sign of the coeliac disease.
How do you know that a testing device works correctly?
A testing device has an internal control integrated. When a colour line appears in the control area of a testing device, it means that a testing device works correctly.
Are blood collection accessories included in the testing kit?
Yes, they are. You receive everything you need to perform the H. pylori test at home.
1 NASPGHAN, 2005. Clinical Guideline: Guideline for the Diagnosis and Treatment of Celiac Disease in Children: Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. Journal of Pediatric Gastroenterology and Nutrition, 2005(40), 1-19.
2 European Commission. Tools and Databases, Legislation. Accessible at: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.nb&refe_cd=EPOS_43805 (10. 03. 2020).
3 Kelly, C. P., Bai, J. C., Liu, E., & Leffler, D. A. (2015). Advances in diagnosis and management of celiac disease. Gastroenterology, 148(6), 1175–1186.
4 Jean-Pierre O., et al., 2014. New European Recommendations for the Diagnosis of Celiac Disease in Children: Did the Experts Make it Simple? International Journal of Celiac Disease, 2014(2(3)), 86-88.
5 Freeman J. H., 2010. Risk factors in familial forms of celiac disease. World Journal of Gastroenterology, 2010(16(15)), 1828-1831.
6 Catassi, C., Elli, L., Bonaz, B., Bouma, G., Carroccio, A., Castillejo, G., Cellier, C., Cristofori, F., de Magistris, L., Dolinsek, J., Dieterich, W., Francavilla, R., Hadjivassiliou, M., Holtmeier, W., Körner, U., Leffler, D. A., Lundin, K. E., Mazzarella, G., Mulder, C. J., Pellegrini, N., … Fasano, A. (2015). Diagnosis of Non-Celiac Gluten Sensitivity (NCGS): The Salerno Experts’ Criteria. Nutrients, 7(6), 4966–4977.
7 Sapone A., et al., 2012. Spectrum of gluten-related disorders: consensus on new nomenclature and classification. BMC Medicine, 2012, 10:13.
8 Steel R. Diagnosis and management of coeliac disease in children. Postgraduate Medical Journal, 2011(87), 19-25.
9 Husby S. et al. ESPGHAN Guidelines for Diagnosis of Coeliac Disease. Journal of Pediatric Gastroenterology and Nutrition, 2012, 54(1).
10 International Organization for Standardization. ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes. Accessible at: https://www.iso.org/standard/59752.html (10. 03. 2020).