Essential information about the Patris Health® PSA Home Test
Key Facts
The Patris Health® PSA Home Test detects the concentration of Prostate-Specific Antigen higher than 4 ng/mL, which is a reference standard in screening for benign or malignant prostate hypertrophy.
- Intended use: Detection of Prostate Specific Antigens (PSA).
- For self-testing: No experience needed.
- Sample type: Finger capillary blood.
- Testing time: 15 minutes
- Accuracy: At least 87%, clinically validated.
- Certificates: ISO 13485, CE0483
- Compliance: European directive 98/79/EC on the in vitro diagnostic medical devices.
- Trade name: Patris Health® – PSA Home Test
- Made in France
Kit Contents
The Patris Health® PSA 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.
Important: You should wait indicated time before performing the test in the following cases:
- Cycling/Ergometry: 24 hours
- Ejaculation: 24 hours
- Prostate massage: 2-3 days
- Transrectal ultrasounds: 2-3 days
- Cystoscopy: 1 week
- Prostate transurethral resection/biopsy: 4-6 weeks
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 the PSA level is higher than 4 ng/mL.
- Do not panic.
- Consult your doctor about further examination.
Negative: Only a Control line (C) appears.
- Such a result indicates that the PSA level is under 4 ng/mL.
- From time to time, check your PSA, especially if there are know prostate conditions in the family.
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@patris-health.com
Frequently Asked Questions about the Patris Health® PSA Home Test
Screening is especially recommended to men over 50 years. Moreover, The risk of being diagnosed with prostate cancer increases twofold if one first-degree relative is diagnosed and by a factor of four if two or more relatives are affected.1
1 Giri, V. N., & Beebe-Dimmer, J. L. (2016). Familial prostate cancer. Seminars in oncology, 43(5), 560–565. https://doi.org/10.1053/j.seminoncol.2016.08.001
No. A positive result does not necessarily mean that you have prostate cancer. Still, it indicates changes in the physiological condition of the prostate that increased the level of PSA in the blood.
Various activities can increase the level of PSA in blood. Therefore, if anything of the following relates to you, you should wait indicated time before performing the test.
Cycling/Ergometry: 24 hours
Ejaculation: 24 hours
Prostate massage: 2-3 days
Transrectal ultrasounds: 2-3 days
Cystoscopy: 1 week
Prostate transurethral resection/biopsy: 4-6 weeks
A clinical performance evaluation study demonstrated that the test is at least 87% accurate.
Moreover, it is very reliable. It is based on proven technology used in clinical settings for over 10 years.
The Patris Health® PSA 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.
