Prostate PSA self-test for home use

What is being investigated?

The PSA self-test measures the prostate-specific antigen (PSA) in the blood. PSA is a protein produced in the prostate gland and, among other things, contributes to the liquefaction of the ejaculate.

Determining the PSA level can provide indications of changes in the prostate and serves as a guide for self-assessment .

For whom might the test be useful?

The test can be used as part of regular screening , especially for:

• Men aged approximately 45 and over
• Men with urinary tract problems , such as increased urge to urinate or difficulty urinating

Regular monitoring of PSA levels can help to detect abnormalities early and, if necessary, to investigate them further.

Test principle and performance data

The PSA test is a rapid immunochromatographic test that detects PSA levels above the threshold of 4 ng/mL .

Performance data of the test:

• Specificity: 87.13%
• Sensitivity: 97.22%
• Accuracy: 92.34%

implementation

The test is conducted entirely at home :

• Taking a blood sample with a sterile lancet
• Take up the blood sample with the capillary pipette up to the mark
• Apply the sample to the designated well (S) of the test cassette.
• Add 2 drops of thinner
• Reading the result after 5 minutes

A line appears in the control area (C), confirming that the test was performed correctly.

Interpretation of the results

• Negative: The PSA level is within the normal range.
• Positive: The PSA level is above the limit – a medical examination is recommended.

The color or intensity of the test line is not decisive for the assessment. Any visible test line is considered positive.

Scope of delivery

The test kit contains:

• 1 test cassette
• 1 dropper bottle with thinner
• 2 sterile lancets
• 1 capillary pipette for blood collection
• 1 antiseptic cleaning gauze
• Instructions for use