CONTENT OF THE KIT
- Test cassette
- Pipette
- Sterile safety lancet
- Alcohol pad
PRECAUTIONS
-
Carefully follow the instructions exactly.
- Only use supplied materials.
- Wash the hands thoroughly to avoid contamination of the specimen. Contamination may cause erroneous result.
- This kit is for in vitro use only. Do not swallow.
- Discard after first use. The test can only be used once.
- Do not use test kit beyond the expiration date.
- Do not use the kit if the pouch is punctured or not well sealed.
- Keep out of children's reach.
STORAGE AND STABILITY
- Store at 4°C to 30°C in the sealed pouch up to expiration date.
- Keep away from sunlight, moisture and heat.
- Use the test shortly after opening the pouch.
TEST PROCEDURE
- When the test have been stored in a cold room, wait for it to reach room temperature (10 - 30°C).
- Open the pouch and place the cassette on a level surface.
- Clean the area to be lanced with the alcohol pad. Wait for the area to dry completely (do not blow on it).
- Use the safety lancet and pipette. The safety lancet can only be used once.
|
Twist off the green protective
cap, and then pull it straight out |
|
Press the lancet firmly against the puncture site to activate the device
|
|
Gently apply intermittent pressure near the puncture site to obtain the required blood volume |
Squeeze the pipette together and collect blood by slowly releasing the pressure.
- Add Three drops of blood to the round well of the cassette.
HOW TO INTERPRET THE RESULT
Read the test result after 5 - 15 minutes. Do not read the result after 15 minutes.
Positive (Elevated PSA value):
Two (2) pink/purple bands form, and the color of the test band is equal to or more intense than that of the control/reference band. This result indicates the presence of PSA in the specimen at a level equal to or greater than 4 ng/ml.
Negative (Normal PSA value):
One (1) pink/purple band forms in the control region and no band is found in the test region, or the color of the test band is less intense than that of the control band. This result indicates the presence of PSA in the specimen at a level lower than 4 ng/ml.
Invalid:
No visible band at all, or there is a visible band only in the test region but not in the control region. The most common reason for this is that the instructions have not been followed exactly.
