Prostate Screening Test Instructions

In-Vitro Diagnostic Self Test For Home Use. For external Use Only.

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

What is PSA?

Prostate Specific Antigen (PSA) is a protein in your blood secreted by the prostate gland.

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.

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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: Watch, clock or timer with a ‘second’ and ‘minute’ counter.

How to Use the Test

1) Wash your hands with soap and rinse with clear warm water.

2) Tear the protective pouch (from the notch) and only get out the device and the pipette. Dispose of the small desiccant bag.

3) Push the orange small rod into the body of the lancet until hearing a CLICK indicating the device is activated.

Be careful not to push the trigger because the needle can come out too early.

4) Remove the orange rod by turning it on the left or on the right.

5) Clean the end of the forefinger or of the middle finger with a cotton pad damped with alcohol.

Massage the end of the finger, from the base of the finger to the end, to enhance the blood flow.

6) Strongly press the extremity of the lancet on the part of the finger which is cleaned with alcohol in order to obtain a very good contact.
Press on the trigger button.

The tip retracts automatically and safely after use.

7) Keeping the hand down massage the end that was stung to obtain a blood drop.

8) Without pressing the pipette bulb, put it in contact with the drop.

The blood migrates into the pipette through the capillarity to the line indicated on the pipette.
You may massage again your finger to obtain more blood if the line is not reached. As far as possible, avoid of air bubbles.

9) Put the blood collected with the pipette into the sample well of the device, by pressing on the pipette bulb.

10) Wait for the blood totally being dispensed in the well. Using the dropper bottle, add 5 drops of diluent into the sample well of the device.

11) Read the result after 10 minutes.

How to read your results

POSITIVE RESULT
Two coloured lines appear in the window under the marks T (Test) and C (Control). The intensity of the line T may be clearer than the intensity of the line C.
This result means that the prostate specific antigen level is higher than the norm and that you should consult a doctor.

NEGATIVE RESULT
Only one coloured line appears under the mark C (Control). This result means that the prostate specific antigen level is normal.

NON VALID RESULT
No line appears or a coloured line appears under the mark T (Test) without any line under the mark C. In this case, it is not possible to interpret the test, which must be considered as non valid. It is recommended to repeat the test with a new Test PSA and a sample of fresh blood.

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 One-Step Whole Blood 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.

The One-Step Whole Blood 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.

To download the full instructions for use please click ont h link below;

Instructions of use – English

Istruzioni per l’uso – Italiano

Gebrauchsanweisung – Deutsch

Notice d’utilisation – Français