Essential Information about the The Patris Health® Coeliac Disease Home Test
How to perform the 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.
- Intended use: Detection of anti-Tissue Transglutaminase (tTG) IgA antibodies.
- For self-testing: No experience needed.
- Sample type: Finger capillary blood.
- Testing time: 20 minutes.
- Accuracy: At least 97,03%, clinically validated.
- Certificates: ISO13485, CE0483
- Compliance: European directive 98/79/EC on the in vitro diagnostic medical devices.
- Trade name: Patris Health® – Coeliac Disease Home Test
- Made in France
The Patris Health® Coeliac Disease Home 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.
Testing takes about 20 minutes. 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, you should take the result into account.
Positive result: 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 result: 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 result: 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 firstname.lastname@example.org
Frequently Asked Questions about the Patris Health® Coeliac Disease Home Test
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 you are on a gluten-free diet for longer than two months, this test is not relevant. Probably, your blood will not contain detectable antibodies against tissue-transglutaminase that this test detects. Therefore, testing is irrelevant.
The test is not suitable for children under two years old. In such a case, consult your doctor for an appropriate laboratory examination.
Not directly. Unfortunately no specific tests for gluten sensitivity exist. 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 rule out the presence of IgA-tTG antibodies that are a clinical sign of coeliac disease.
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.
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.
If, for any reason, the test does not work, please take a photo of it, and send it to us by email at email@example.com
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. The test kit comes with illustrated and explanatory instructions for use. If you follow them, you will not have any difficulties.