Essential information about the Patris Health® Helicobacter pylori Home Test
Key Facts
After infection with H. pylori, the immune system produces specific antibodies directed against bacteria. Our H. pylori Home Test is a serology test that detects these antibodies in the blood and, on this principle, indicates the infection.
- Intended use: Detection of antibodies against Helicobacter pylori.
- For self-testing: No experience needed.
- Sample type: Finger capillary blood.
- Testing time: 15 minutes
- Accuracy: At least 90%, clinically validated.
- Certificates: ISO 13485, CE0483
- Compliance: European directive 98/79/EC on the in vitro diagnostic medical devices.
- Trade name: Patris Health® – Helicobacter pylori Home Test
- Made in France
Kit Contents
The Patris Health® Helicobacter pylori 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 Procedure
Testing will take 15 minutes of your time. Individuals usually need about 5 minutes to perform the analysis, and then there is a 10-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 10 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: Control (C) and Test (T) lines appear.
- Such a result indicates an infection with H. pylori.
- Do not panic.
- Consult your doctor about further examination.
Negative: Only a Control line (C) appears.
- Such a result indicates that you are not infected.
- The negative result may also be due to the low concentration of anti-H. pylori antibodies. This may also be the case if you got infected just recently and the immune system did not yet produce a detectable concentration of antibodies.
- If symptoms persist, consult your doctor for laboratory examination.
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 help@patrisadmin
Frequently Asked Questions about the Patris Health® Helicobacter pylori Home Test
No. Serology tests like ours are not appropriate because antibodies against H. pylori can stay in the blood for several years after treatment, and the result can be false-positive. It means that the test can show positive results although you are not infected.
No. Serology is not a suitable diagnostic technique for the eradication treatment follow-up. Consult your doctor for laboratory examination.
No, it is not necessary to stop. Specific antibodies against Helicobacter pylori can also be detected in case of ongoing therapy with PPI medications.1
1 Enko, Dietmar & Halwachs-Baumann, Gabriele & Stolba, Robert & Rössler, Ortrun & Kriegshäuser, Gernot. (2016). Performance evaluation of a rapid whole-blood immunoassay for the detection of IgG antibodies against Helicobacter pylori in daily clinical practice. Annals of Clinical Microbiology and Antimicrobials.
Yes, even though the test line (T) is barely visible, you should interpret such a result as positive. The Colour intensity of the test line and control line can also be different. It only matters that is visible, no matter the colour intensity.
A clinical performance evaluation study demonstrated that the test is at least 90% accurate. Results were compared against results obtained with ELISA, Western Blot, and Biopsy cell culture techniques.
Competitive brands compare performance only to ELISA laboratory technique. In this category, our test achieved the following.
Sensitivity: 94.12 %
Specificity: 100 %
Moreover, our H. pylori test is very reliable. It is based on proven technology and has been used in clinical settings for over 10 years.
The Patris Health® Helicobacter pylori 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.
If, for any reason, the test does not work, please take a photo of it, and send it to us by email at help@patris-health.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.
