PSA Self-Test for Home Use (Prostate Check)

Test your PSA levels at home in peace and quiet with our fast, CE-marked self-test. With a simple prick on the fingertip (capillary blood), you get a reliable indication of potentially elevated PSA levels within 5 minutes. Sent in a completely neutral and discreetly packaged envelope directly to your mailbox.

How to perform the test in short

1. Sampling: Clean the fingertip with the provided alcohol pad and prick with the sterile lancet. Wipe away the first drop of blood and collect new blood with the capillary dropper up to the marked line.
2. Preparation: Add 1 drop of blood into the specimen well (S) on the test cassette, followed by 1 drop of buffer.
3. Reading: Read the result at 5 minutes. (Do not interpret the result after 10 minutes have passed).

Result interpretation & Important advice

• Positive result (Two colored lines C and T): Indicates that the PSA level in the blood is 4 ng/mL or higher. Important: A positive result does not automatically mean you have prostate cancer, as elevated PSA values can also be caused by benign prostatic hyperplasia (BPH) or inflammation (prostatitis). However, you should always contact a doctor or healthcare center for further clinical evaluation.
• Negative result (One colored line at C): Indicates that the PSA level is below 4 ng/mL. If you have persistent urinary tract symptoms (e.g., difficulty urinating or frequent urge), you should still consult a doctor.
• Important limitations: The test is an indicative rapid test and does not replace a full medical evaluation by a physician.

Specifications & Product Information

CE-marked IVD product for self-testing by laypersons according to IVDR (EU) 2017/746

• Product name: Prostate-Specific Antigen (PSA) Rapid Test (REF: TPS-NQ402H)
• Risk class (IVDR): Class C
• Intended purpose: Rapid test for the qualitative detection of total Prostate Specific Antigen (PSA) in human finger prick blood
• Detection limit (Cut-off): 4 ng/mL
• Results within: 5 minutes (do not interpret after 10 minutes)
• Sample type: Capillary blood (finger prick blood)
• Performance characteristics:
  • Diagnostic sensitivity: 98.0 %
  • Diagnostic specificity: 99.1 %
  • Overall agreement: 98.8 %
• CE marking & Notified body: CE 3018
• Legal manufacturer: Hangzhou AllTest Biotech Co., Ltd., #550 Yinhai Street, Hangzhou, China
• EU Authorized Representative: MedNet EC-REP GmbH, Borkstrasse 10, 48163 Muenster, Germany