Essential information about the Patris Health® Coeliac Disease Home Test
The Patris Health® Coeliac Disease Home Test is a certified immunological rapid test to determine tTG-IgA antibodies in the blood, which are a clinical sign of coeliac disease.
Anti-tTG IgA antibodies are a first-level clinical marker in the diagnosis of coeliac disease.
Frequently asked questions about the Patris Health® Coeliac Disease Home Test
The test kit includes:
- one testing device,
- one diluent buffer,
- two micro-pipettes for blood transfer,
- two lancets to puncture a fingertip,
- one alcohol pad to disinfect the puncture site,
- detailed instructions for use with the illustrative step-by-step testing procedure.
Note: You need only one pipette and one lancet to perform the test. Extra one pipette and one lancet are included in the kit as spare parts if you need them to complete the testing procedure successfully.
You do not need to ingest gluten right before performing the test. Nevertheless, it would be best if you weren’t on a gluten-free diet.
If, for any reason, the test device does not work, please take a photo of it, and send it to us by email at [email protected]
Please note: Our tests are straightforward and designed for non-professionals. Errors happen when individuals do not follow instructions for use strictly. You must not skip any step of the testing procedure, and you must respect the exact quantity of blood and testing solution and time. The test kit comes with illustrated and explanatory instructions for use. If you follow them, you will not have any difficulties.
Yes, testing is effortless. You need to collect a drop of blood from your fingertip. Then you add it to the test device, and add a test solution afterwards.
Individuals usually need about 5 minutes to perform the analysis. Then there is a 15-minute waiting time for the result.
Why Patris Health® Coeliac Disease Home Test?
It is more sensitive and specific for coeliac disease than conventional DPG (deamidated gliadin peptide) tests.
It is more accurate (97%) than recommended standard of 95 % by the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition Guidelines for the Diagnosis of Coeliac Disease.1
You do it yourself: Your carry out the analysis by yourself at home. There is no need to send a sample in the laboratory or visit a doctor office to perform the test.
It is fast: Testing takes only 15 minutes of your time, 5 minutes for the analysis and 10 minutes waiting time for the result.
It is easy: No special training is required. Test kits are designed for non-professionals. Even if you do not have any experience with self-testing, you will be able to perform the analysis flawlessly. Explanatory step-by-step instructions will guide you throughout the testing procedure.
It is accurate and reliable: You can trust the result. The test is clinically validated and it is based on the technology used also in laboratories.
1 Husby S. et al. ESPGHAN Guidelines for Diagnosis of Coeliac Disease. Journal of Pediatric Gastroenterology and Nutrition, 2012, 54(1).
2 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.
Accuracy and Reliability
A clinical performance evaluation study demonstrated that the test is at least 97% accurate.
Moreover, it is very reliable. It is based on proven technology used in clinical settings for over 10 years.
The Patris Health® Coeliac Disease Home Test is manufactured in France with premium materials according to ISO13485. It is CE0483 certified in Germany and approved for home use by the European authorities.
1-2% of people worldwide have coeliac disease, many suffering, but not diagnosed.
Testing will take 20 minutes of your time. Individuals usually need about 5 minutes to perform the analysis, and then there is a 15-minute waiting time for the result.
- Draw a drop of blood from a fingertip.
- Add the blood and testing solution to the test device.
- Wait 15 minutes and read the result.
The test kit comes with detailed instructions for use. Follow the procedure exactly as instructed, and you will not have any difficulties performing the analysis.
Interpretation of the results
Results are interpreted visually as positive, negative or invalid. The colour intensity of the test line and control line can be different. If the line is visible, the result should be taken into account.
Positive: Control (C) and Test (T) lines appear.
- Such a result indicates that your blood contains anti-t-TG IgA type antibodies, and you might have a coeliac disease.
- Do not panic.
- Consult your doctor about further examination.
Negative: Only a Control line (C) appears.
- There are no anti-t-TG IgA type antibodies or below the detection limit (10 U/mL tTG reference).
- If you still experience symptoms of coeliac disease, you might have a non-celiac gluten sensitivity. In such a case, you should consult with your doctor.
Invalid: Invalid result appears if you do not carefully follow instructions for use. Please take a photo of such a test result and contact us at [email protected]