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Prostate Screening Test Instructions

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

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

About PSA

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.

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

1 test device and dropper
1 vial of test solution
2 finger prick devices
1 alcohol swab
(lancets – National Standards Authority of Ireland (NSAI) Identification No. 0050. 93/42/EEC)

ADDITIONAL MATERIALS REQUIRED
Watch, clock or timer with a ‘second’ and ‘minute’ counter.

How to Use the Test

  1. Wash your hands. Remove the test device and dropper from the foil package by tearing along the perforation on the package.

  2. Wipe the finger you intend to prick with the alcohol swab. Warm up your hands by massaging them.
  3. Using the finger prick device (lancet) provided, prick your finger as follows:
    Turn the white protective tab completely round at least two times, then pull the white protective tab carefully from the finger pricker. Protate_Test_Intstructions
    Place the lancet firmly against your fingertip and press. Whilst pressing, push the white button firmly until a ‘click’ is heard. The needle will retract into the finger pricker for safe disposal. You will feel a rather painless prick in the finger. The finger pricker is for single use only and may not be reused. Protate_Test_Intstructions_2
    Squeeze your finger, making sure you get a large hanging drop of blood Protate_Test_Intstructions_3
  4. Hold the dropper provided horizontally (flat) and touch the tip of the dropper to the drop of blood. Do not squeeze the bulb. Blood will flow into the dropper. You may need to squeeze your finger to get additional blood. There is a line on the dropper. Fill to the line.
  5. Place the filled dropper against the sample well (round hole) marked with an S on the test device.
  6. Squeeze the top of the dropper, ensuring the entire blood sample fills the test device.
  7. Wait 90 seconds after adding the blood to the sample well, twist open the cap of the test solution vial and slowly add five (5) drops of test solution to the diluent well, marked with a D.
  8. Start the timer.
  9. Read the results at exactly 10 minutes. Do not attempt to read or obtain a test result before or after 10 minutes.

How to read your results

Look at the test device – in the results window there is a ‘control area’ marked with a C and a ‘test area’ marked with a T.

If there are two lines in the results window, one in the control area and one in the test area, the test is positive.
If there is only one line in the results window, in the control area, then the test is negative. Protate_Test_Intstructions_2
If there are no lines in the results window or if there is only one line, in the test area, then the test is invalid and should be repeated. Protate_Test_Intstructions_2

Please Note: When you read the results, the colour and intensity of the lines do not matter. It does not matter which line is darker. If the line is visible and unbroken, you can interpret the result as described above. Call your doctor to discuss your test results or if you have any concerns or prolonged symptoms.

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 EZ-PSATM 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 EZ-PSATM 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 EZ-PSATM One-Step Whole Blood Test is very accurate, erroneous results may occur. Always check with your doctor if you get unexpected results.

Further Information

Particular attention should be paid to: