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Test instructions: Hepatitis C (Anti-HCV)

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CONTENT OF THE KIT

  1. Test cassette
  2. Pipette
  3. Bottle of buffer solution
  4. Sterile safety lancet
  5. Alcohol pad

PRECAUTIONS

  1. Carefully follow the instructions exactly.
  2. Only use supplied materials.
  3. Wash the hands thoroughly to avoid contamination of the specimen. Contamination may cause erroneous result.
  4. This kit is for in vitro use only. Do not swallow.
  5. Discard after first use. The test can only be used once.
  6. Do not use test kit beyond the expiration date.
  7. Do not use the kit if the pouch is punctured or not well sealed.
  8. Keep out of children's reach.

STORAGE AND STABILITY

  1. Store at 4°C to 30°C in the sealed pouch up to expiration date.
  2. Keep away from sunlight, moisture and heat.
  3. Use the test shortly after opening the pouch.

TEST PROCEDURE

  1. When the test have been stored in a cold room, wait for it to reach room temperature (10 - 30°C).
  2. Open the pouch and place the cassette on a level surface.
  3. Clean the area to be lanced with the alcohol pad. Wait for the area to dry completely (do not blow on it).
  4. 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.

  5. Add One drop of sample, from the pipette, to the round well of the cassette (marked with S).
  6. Wait 20 seconds.
  7. Add Two drops of buffer solution, from the bottle, to the round well of the cassette (marked with D).
  8. If the liquid is not moving across the membrane within one minute, add one more drop of buffer solution to the round well of the cassette (marked with D).

HOW TO INTERPRET THE RESULT

Read the test result after 15 minutes. Do not read the result after 20 minutes.

Positive (Hepatitis C infection):

Colored lines are visible in the control region and the test region. This means that infection by Hepatitis C has been detected. Another test is required 6 months later, if this test also is positive, the diagnosis is chronic Hepatitis C infection.

Note:

There is no meaning attributed to line color intensity or width.

Negative (No Hepatitis C infection):

One colored line is visible in the control region and no colored line in the test region. This means that no Hepatitis C infection was detected.

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.

LIMITATIONS:

  1. This test is a qualitative test. The test can not be used to determine the quantitative concentration of Anti-HCV.
  2. A negative test does not rule out infection by Hepatitis C because the antibodies may be absent or may not be present in sufficient quantity to be detected at early stages of infection.
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