PRIMA Home Test - Prostrate Test Kit - PSA Health Test - An easy to use visual test to detect abnormal levels of Prostate Specific Antigen (PSA) above the normal range

This test (for men only) is an easy to use visual test to detect abnormal levels of Prostate Specific Antigen (PSA) above the normal range. This test is easy to use and results can be read in 10 minutes.

Pack Contents

• 1 device for the test and 1 desiccant bag
• 1 dropper vial containing 1mL of diluent
• 2 painless sterile lancets for blood sampling
• 1 instructions for use

Prostate Test Kit

In-Vitro Diagnostic Self Test For Home Use.

An easy to use visual test to detect abnormal levels of Prostate Specific Antigen (PSA) above the normal range in men.

What is PSA?

Prostate Specific Antigen (PSA) is a protein in mens blood secreted by the prostate gland. PSA appears in your bloodstream in higher concentrations when the gland is enlarged or cancerous.

How does this test work?

The level of PSA is measured in the blood sample. Elevated levels (greater than 4ng/ml) may be an important signal of possible prostate disease. This test is designed with a cut off level of 4ng/ml.

What do I do if the test indicates a positive result?

This test is meant only as a screening tool, if you get a positive result, call your doctor and discuss the result. Your doctor may decide to run more tests.

How long do I have to wait to read the results?

The test results must be read at 10 minutes after the addition of the test solution. The results are not valid if they are read after 10 minutes.

What if the lines in the results window are not the same colour or intensity?

The colour or intensity of the lines in the results window do not have any significance. If the lines are visible then they can be interpreted as explained in the test results interpretation section of this leaflet.

What is the purpose of the line in the control area?

The line in the control area assures you that the test was run correctly. If no line appears in the control area then the test is invalid and should be repeated.

Test Contents:

• 1x Foil Pouch containing test device and dropper
• 1 x vial of test solution
• Finger prick devices

ADDITIONAL MATERIALS REQUIRED (Not supplied in this kit): Watch, clock or timer with a ‘second’ and ‘minute’ counter.

Limitations of the Test

This is a screening test. Additional clinical investigations will be needed for a final diagnosis. If you get a positive result, you should consult your doctor immediately. Further medical consultation and investigations with your GP are essential, this may include a further PSA test and a digital rectal exam and other methods of diagnosing prostate disease.

The test is not reusable. The test only works if the instructions are followed very carefully. Once the test has finished and the results obtained, the device and all the related items, including the used finger pricker, should be returned to the original packaging, resealed and disposed of with the usual household waste.

This test uses a multi-layer filtration, flow and antibody system to develop a coloured line to show the test is working correctly and if the level of PSA present is greater than 4ng/ml in whole blood. Although the One-Step Whole Blood Test is very accurate, erroneous results may occur. Always check with your doctor if you get unexpected results.

Further Information

• Store in a dry place at 15-30°C. Do not freeze.
• Keep out of the reach of children.
• Do not use after the expiry date.
• Do not use if the package is torn or damaged. If the carton is not intact return the product to the place of purchase.
• For in-vitro diagnostic use. Not for internal use.

Instructions For Use

To download the full instructions for use please click on a link below:-

- Prostrate PSA Test Instructions - English (EN), Spanish (ES) and Portuguese (PT)

- Prostrate PSA Test Instructions - Germand (DE), French (FR) and Italian (IT)

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