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Test instructions: Colorectal Cancer (FOB)

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CONTENT OF THE KIT

  1. Test cassette
  2. Bottle of buffer solution with collector

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.
  9. Do not collect sample when patient has hemorrhoids bleeding or during the menstrual period.
  10. If the subject ate meat, pluck or chalybeate food, the Chemical Method test result may show positive.

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.

SPECIMEN COLLECTION AND PREPARATION

  1. Unscrew the cap of the buffer bottle and take out the collection stick.
  2. Collect sample by dipping the stick into three different places of the stool sample.
  3. Put the collection stick back in the cap and screw the cap back on the buffer bottle.

TEST PROCEDURE

  1. When the test have been stored in a cold room, wait for it to reach room temperature (10 - 30°C).
  2. Collect sample.
  3. Shake the buffer bottle until specimen is dissolved.
  4. Open the top of the cap and squeeze out 2-3 drops of solution into the middle well marked with an S.

HOW TO INTERPRET THE RESULT

Read the Chemical Method result through the sample pad in 1 minute and read the Immune Colloidal Method result through the result window after 5 minutes.

Interpretation of Immune Colloidal Method:

  1. Positive: Colored lines are visible in the control region and the test region.
  2. Negative: One colored line is visible in the control region and no colored line in the test region.
  3. Invalid: No visible band at all, or there is a visible band only in the test region but not in the control region.

Interpretation of Chemical Method:

  1. Positive: The color of the sample pad changes from orange to yellow-green or dark green within 1 minute after adding the sample.
  2. Negative: There is no color change in the sample pad within 1 minute after adding the sample.

Final interpretation:

  1. Both methods show positive: the final result is positive which indicates bleeding in the specimen.
  2. The Immune Colloidal Method shows positive while Chemical Method shows negative: this indicates occult bleeding.
  3. The Immune Colloidal Method shows negative while Chemical Method shows positive: This is probably because the high concentration of hemoglobin causes antigen excess and have hook effect. The sample should be diluted 100 times and retested, if Immune Colloidal Method shows positive this indicates the enteron is bleeding profusely, if Immune Colloidal Method still shows negative, this indicates that some substances interfered and the result should be negative.
  4. Both methods show negative: The result is negative
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