Prostate Specific Antigen (PSA)

Table of contentsAbout the Patris Health® PSA Home TestKey FactsKit ContentsTesting ProcedureInterpretation of the ResultsFrequently Asked Questions about the Patris Health® PSA Home TestAbout the Patris Health® PSA Home TestThe 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.Our PSA blood test is highly accurate and reliable. It is at least 87% accurate and has been used for over 10 years in hospitals and laboratories. It is manufactured in France according to ISO13485 and approved by the European authorities for self-testing.Key Facts 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 FranceKey facts about the Patris Health® Prostate PSA Home Test.Kit ContentsThe 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.Display of the Patris Health® Prostate PSA Home Test kit contents.Testing ProcedureTesting 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 hoursEjaculation: 24 hoursProstate massage: 2-3 daysTransrectal ultrasounds: 2-3 daysCystoscopy: 1 weekProstate transurethral resection/biopsy: 4-6 weeksIllustration of the testing procedure of the Patris Health® Prostate PSA Home Test.Interpretation of the ResultsResults 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 [email protected] of the possible results of the Patris Health® Prostate PSA Home Test.Frequently Asked Questions about the Patris Health® PSA Home TestTo whom is the screening for benign or malignant prostate hypertrophy recommended?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.11 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.2016.08.001If my result is positive, does this mean that I have prostate cancer?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.When shouldn’t the Patris Health® PSA Home Test be performed?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 hoursEjaculation: 24 hoursProstate massage: 2-3 daysTransrectal ultrasounds: 2-3 daysCystoscopy: 1 weekProstate transurethral resection/biopsy: 4-6 weeksHow accurate and reliable is the Patris Health® PSA Home Test?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.What should I do if the test does not work?If, for any reason, the test does not work, please take a photo of it, and send it to us by email at [email protected] 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.