Hepatitis Test Manual

Hepatitis C (Anti-HCV) Test Cassette Manual

CONTENT OF THE KIT

1. White pouch (white test cassette, dessicant, plastic pipette)
2. Bottle of buffer solution
3. Sterile safety lancet

PRECAUTIONS

1. Carefully follow the instructions exactly.
2. Only use the included pipette.
3. This kit is for in vitro use only. Do not swallow.
4. Contaminated blood may cause erroneous results.
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 childrens reach.

STORAGE AND STABILITY

1. Store at 4ºC to 30ºC 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.
4. Do not freeze.

TEST PROCEDURE

1. When the test have been stored in a cold room, wait for it to reach room temperature (10- 30°C).
2. Wash the hands thoroughly to avoid contamination of the specimen.
3. Open the pouch and place the cassette on a level surface.
4. Use the safety lancet and pipette. The safety lancet can only be used once.

Squeeze the pipette together and collect blood by slowly releasing the pressure.

1. Add One drop of blood to the well of the cassette marked with S.
2. Add Two drops of buffer solution to the well of the cassette marked with D.

HOW TO INTERPRET THE RESULT

Read the result after 15 minutes. Do not read the result after 20 minutes.A positive result may develop even sooner at a high concentration. However, the lower the concentration of the Anti-HCV, the longer time it takes to develop a test band; therefore, a negative result should be determined at 15 minutes to ensure it is truly negative instead of weak positive.

Positive (Hepatitis C infection):

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

The intensity of the color of the lines can vary; no meaning is 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:

There are no colored lines or only a colored line in the test region. The most common reason for an invalid test result is that the test procedure was not carried out properly.