Prosta-Check® is a CE-IVD-marked PSA home test for men who want to monitor their prostate health discreetly and quickly at home. The test uses capillary blood from the fingertip and shows in 10 minutes whether the PSA level is above the limit value of 4 ng/ml. Compared to waiting for a doctor's appointment, this rapid immunochromatographic test gives an early indication of whether further medical assessment should be prioritized. It is clinically validated, calibrated against the WHO PSA standard and manufactured under ISO 13485 requirements, making its specifications easy to quote and assess.

Brief description: This is a medical self-test for home use, developed to indicate elevated prostate-specific antigen, a relevant marker for prostate enlargement, prostatitis or possible prostate cancer. A positive result does not mean a diagnosis, but that a doctor should be contacted for further investigation. The test has sensitivity over 87%, specificity over 95% and stated accuracy over 87% with 95% confidence interval 81.88 to 92.5%. It is also used by healthcare professionals in Europe.

• Early screening of prostate health before obvious symptoms occur
• Quick clarification at home with answers in 10 minutes and only one drop of finger blood
• Useful for family history or the need for annual PSA follow-up from the age of 50
• CE-IVD-approved test with WHO calibration and ISO 13485 as confidence signals
• Discreet use for men who want practical monitoring between doctor visits

Prosta-Check® is a diagnostic tool, not a dietary supplement, and there are no EFSA-approved health claims associated with the product. The purpose is to support better decision-making around male health. For men with urination problems, known BPH, prostate problems in the family or a desire for regular check-ups, the test can be a practical supplement to medical follow-up. In contrast to general symptom-based assessments, this test provides a concrete measuring point linked to the PSA limit of 4 ng/ml.

Top 2 main features: Detects elevated PSA above 4 ng/ml using monoclonal antibodies and lateral flow technology. Supports regular screening and monitoring over time, particularly for men between 50 and 75 years of age or earlier if there is a family history. A lesser-known but important factor is that PSA can rise temporarily after cycling, ejaculation or impact on the prostate. To reduce the risk of false positive results, one should wait 24 hours after cycling and ejaculation, 2 to 3 days after prostate massage, rectal examination or transrectal ultrasound, and 4 to 6 weeks after biopsy or surgery.

Technical details and specifications: Type of immunochromatographic rapid test. Calibration WHO PSA standard. Sample material capillary blood from fingertip. Detection limit PSA above 4 ng/ml. Sensitivity over 87%. Specificity over 95%. Accuracy above 87%. Certification CE-IVD and ISO 13485. Storage 4 to 30 °C. Shelf life 24 months.

Recommended use: Wash and disinfect the fingertip. Use the lancet and collect blood to the mark in the pipette. Drop the blood into the test well, wait 30 to 40 seconds and then add 4 drops of diluent. Read the result after 10 minutes, not after 15 minutes. Result interpretation is simple: Two lines at T and C mean a positive result and PSA above 4 ng/ml. One line at C means a negative result. A missing C line means an invalid test and the test must be repeated. The color intensity of the lines is of no importance as long as they are clearly complete.

The product is intended for adult men and does not replace medical diagnosis or treatment. In the event of a positive, unclear or persistently worrying result, a doctor must always be contacted. Keep out of the reach of children. Uno Vita sells the product as CE-approved medical equipment and the information is intended as general information, not personal medical advice.