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About the Patris Health® FIT Home Test (Faecal Immunochemical Test)
The Patris Health® FIT Home Test is a highly specific immunological rapid test. It is not necessary to follow a particular diet before performing the test, as it is in the case of standard guaiac-based tests.
The test is at least 93% accurate and highly reliable. It is manufactured in France according to the ISO13485 standard and certified (CE0483) for self-testing faecal occult blood.
Key Facts
- Intended use: Detection of Occult Blood in Faeces.
- For self-testing: No experience needed.
- Sample type: Faeces.
- Testing time: 15 minutes. Samples need to be collected on three consecutive days.
- Accuracy: At least 93%, clinically validated.
- Certificates: ISO13485, CE0483
- Compliance: European directive 98/79/EC on the in vitro diagnostic medical devices.
- Trade name: Patris Health® – FIT Home Test
- Made in France
Kit Contents
The Patris Health® FIT Home Test kit includes:
- one testing device,
- three faecal sample collection paper strips,
- one sample collector (syringe) with extraction solution,
- detailed instructions for use with the illustrative step-by-step testing procedure.
Testing Procedure
Testing takes about 15 minutes. Individuals usually need about 5 minutes to perform the analysis, and then there is a 10-minute waiting time for the result.
Before performing the test, you must collect faeces samples on three consecutive days.
- Collect a stool sample in three consecutive days (one sample each day).
- Mix the stool sample with the extraction solution.
- Add the extract to the testing device.
- Wait 10 minutes for 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.
- Blood is present in the faeces.
- Do not panic.
- Blood in faeces does not necessarily mean that you have bowel cancer.
- Consult your doctor about further examination.
Negative result: Only a Control line (C) appears.
- There is no blood present in the faeces, or it is below 10 ng/mL.
- From time to time, check for the occult blood in the stool.
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 help@patris-health.com
Frequently Asked Questions about the Patris Health® FIT Home Test
In most cases, in the early stage of diseases, polyps are not bleeding all the time but only intermittently. Therefore, for more reliable information on a condition, stool samples must be collected in three consecutive days to increase the probability of detecting these intermittent bleedings.
Such a procedure gives more accurate test results for the patient, especially in the early stages of diseases and, therefore, a greater probability of curing them.
No, you do not need to follow any diet before testing. The Patris Health® FIT Home Test detects specifically human haemoglobin; therefore, blood from food (e.g. meat) will not affect the test result.
We recommend regulating your bowel movement first and the carry out the test. Moreover, the stool you need to sample should not contact toilet water. Therefore it is better to wait until the stool is back in a healthy state. If diarrhoea persists, we recommend you consult a doctor.
A clinical performance evaluation study demonstrated that the test is at least 93% accurate. It is based on proven technology and has been used in clinical settings for over 10 years.
The Patris Health® FIT 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.
