TEST
PROSTATE

SELF-DIAGNOSTIC

Description
Self-test for the detection of prostate-specific antigen (PSA) in whole blood samples.

How to use
1) Wash your hands with warm, soapy water, rinse with clean water, and dry, or use the provided cleansing gauze. Note: Using warm water facilitates capillary blood sampling because it induces vasodilation.
2) Prepare the necessary materials as follows: open the aluminum pouch, remove only the cassette, and discard the desiccant sachet. Open the plastic pouch containing the pipette. Open the vial by unscrewing the white cap, being careful not to drop it.
3) Carefully rotate the protective cap of the lancet 360° without pulling it. Remove and discard the released cap.
4) Carefully massage the fingertip chosen for the puncture (the side of the ring finger is recommended). It's important to massage from the palm of the hand to the fingertip to improve blood flow. Press the lancet, from the side where the cap was removed, against the fingertip. The tip of the lancet automatically retracts safely after use. If the lancet malfunctions, use the second one provided. If the second one is not needed, it can be disposed of without special precautions.
5) Keeping your hand facing downward, massage your finger until a large drop of blood forms. It's important to massage from the palm of your hand to the knuckle to improve blood flow.
6) Take the pipette without pressing the bulb. Two sampling methods are suggested:
- Hold the pipette horizontally without pressing the bulb and place it in contact with the drop of blood; the blood will flow naturally by capillary action. Remove the pipette when it reaches the black line. If there isn't enough blood, continue massaging your finger until it reaches that line;
– Place the pipette on a clean, flat surface, with the tip protruding. Then, place the drop of blood in contact with the pipette; it will flow naturally by capillary action. Remove your finger when you reach the black line. If there isn't enough blood, continue massaging your finger until you reach that line. Avoid interrupting contact between the blood and the pipette whenever possible to prevent air bubbles from forming.
7) Take the previously opened vial and immediately pipette the blood collected into it. Press the pipette bulb 2 or 3 times to ensure all the blood has flowed into the diluent. Then replace the screw cap on the bottle and mix well for at least 10 seconds.
8) Unscrew the blue cap from the dropper bottle (leave the white cap tightly screwed on). Place 3 drops in the well indicated on the cassette (S).
9) Wait 5 minutes and read the results referring to the next section for interpretation of the results.
INTERPRETATION OF THE RESULTS
READ THE RESULT AFTER EXACTLY 5 MINUTES
The intensity of the color of the lines has no importance for the interpretation of the test result.
POSITIVE RESULT
Two colored lines appear in the reading window corresponding to the T (Test) and C (Control) marks. The intensity of the T line may be lower than the C line. The test should therefore be considered positive regardless of the intensity of the T test line. This result indicates the presence of anti-DGP antibodies in the blood and therefore probable celiac disease. You should consult your doctor to continue the diagnostic process.
NEGATIVE RESULT
Only a colored line appears under the C (Control) mark. This result indicates that there are no anti-DGP antibodies in the blood or that their level is below the detectable limit of the test.
INVALID RESULT
No lines appear, or only a single line appears under the T (Test) mark and not under the C (Control) mark. In this case, the test result cannot be interpreted and should be considered invalid. It is recommended to perform a new test.

Warnings
- Read the instructions for use carefully before performing the test. The test is reliable if the instructions are carefully followed.
- Keep out of reach of children.
- Do not use the test after the expiration date or if the package is damaged.
- Follow the procedure exactly, respecting the indicated quantities of blood and diluent.
- Use the test and the lancet only once.
- The test is for external use only. Do not ingest.
- In vitro diagnostic device for individual use.
- Not recommended for use by people taking medicines that thin the blood (anticoagulants) or by people with haemophilia problems.
- After use, dispose of all components in accordance with local regulations, ask your pharmacist for advice.

Conservation
Store at temperatures between 4°C and 30°C.
Shelf life in intact packaging: 24 months.

Format
Package containing:
- hermetically sealed aluminum pouch containing: 1 PROSTATE PSA TEST cassette and 1 desiccant sachet;
- sterile lancets for self-pricking blood samples;
- dropper bottle containing the PROSTATE PSA TEST diluent, sufficient for 1 test;
- plastic bag containing 1 pipette for blood sampling;
- alcoholic cleansing gauze;
- 1 instruction sheet for use.

Cod. MM-PSA