Prosta-check - self diagnostic psa test

Product Description

Self-testing device for the detection of prostate-specific antigen in the blood.

Indications

Prosta-check is a self-testing device for the detection of prostate-specific antigen in the blood. The PSA test can be performed at least once a year in men over 50 or with family members with prostate problems. The PROSTA-Check® test allows the detection of an elevated blood level of prostate-specific antigen above 4 ng/mL (determined relative to the WHO reference*), which could indicate benign or malignant prostatic hyperplasia.

How to use

The testing procedure always begins with good preparation. Place the contents of the box
on a clean, dry, and flat surface (e.g., a table). Then perform the test:

1. Wash your hands thoroughly. Use soap and warm water. Dry your hands with a clean towel.
2. Prepare the test device and pipette. Remove them from the protective pouch (tear off the notch) and place them within reach (you will need them later). Remove the desiccant pouch.
3. Prepare the test. Hold the test without touching the activation button. Unlock the cap by rotating it 1/4 turn until you feel it separate, then continue rotating (2-3 turns). Do not pull; twist and discard the cap when finished.
4. Clean the tip of your middle or ring finger with cotton swab moistened with alcohol. Rub the chosen finger toward the tip for 10-15 seconds to increase blood flow.
5.  Press the test firmly against the side of the previously cleaned finger and press the release button;
6. The tip automatically retracts into the device.
7. Rub the tip of your finger to obtain a sufficient blood sample.
8. Without pressing, touch the blood sample to the plastic pipette. The blood will move into the pipette by capillary action up to the line indicated on the pipette. You can rub your finger again to obtain more blood if the line is not reached. Avoid air bubbles as much as possible.
9. Put the blood collected with the pipette into the sample port of the device, pressing on the bulb of the pipette.
10. Wait 30-40 seconds for the blood to be fully absorbed into the sample. Unscrew the blue cap of the diluent dropper bottle (leave the white cap tightly screwed on) and add the diluent as follows:
    Hold the diluent bottle upright and slowly add exactly 4 drops to the sample in Device 7 with a 2-3 second interval between each drop.
11. Read the result after 10 minutes. Do not interpret after 15 minutes.

Interpretation of Results

The intensity and color of the lines have no importance for the interpretation of the
test results.

1. Positive Result: Two colored lines appear in the window below the T (Test) and C (Control). The intensity of the T line may be higher than the C (Control). clearer than the C line. This result means that the prostate-specific antigen level is higher than normal and that you should consult a doctor.
2. Negative result: Only one colored line appears under the C (Control). This result means that the specific antigen level is normal.
   Invalid result: No line appears or a colored line appears under the T (Test) without any line under the C. In this case, the test cannot be interpreted and should be considered invalid. We recommend repeating the test with a new PROSTACheck® and a new blood sample.

Warnings

This test is intended for in vitro diagnostics only. For external use only. Do not ingest. Read the instructions carefully before performing the test. The test is interpretable only if the instructions are carefully followed. Strictly follow the indicated time, blood quantities and diluent. Store between +4°C and +30°C. Do not freeze. Do not use after the expiry date printed on the label and the protective pouch, or if the pouch is damaged. Do not reuse the Prosta-Check test. Keep it out of the reach of children. After use, all components can be thrown away.

Format

1 sealed aluminum pouch containing:

• 1 test device;
• 1 plastic pipette;
• 1 desiccant sachet. Open the pouch only when you are ready to use the test. The desiccant sachet should not be used.
• 1 dropper bottle containing 1 mL of diluent;
• 1 sterile blood sampling needle; 1 instruction leaflet