Package leaflet

  • GENERAL

    Blood in the stool may be an indication of various gastrointestinal diseases. These diseases can have a variety of causes such as ulcers, polyps, colitis, anal fissures and colorectal cancer. These disorders cannot be detected by visual examination, and the symptoms are often unnoticeable. A gastrointestinal disorder can only be diagnosed by the presence of blood in the stool. From the age of 45, the stool must be checked for traces of blood at least once a year. The FECOTEST® is a very specific, rapid, immunological test. Unlike guaiac tests, FECOTEST® does not require you to follow a specific diet beforehand. There are indications to suggest that, in the majority of early diagnosed cases, polyps only bleed intermittently. That is why stool samples must be collected for 3 consecutive days to increase the likelihood of detecting bleeds, to obtain a more accurate diagnosis for the patient.

  • PRESENTATION

    The box contains the equipment required for one test:

    1 aluminium pouch, hermetically sealed, containing: 1 test kit, 1 desiccant pouch.

    Only open the foil package and use the test kit after you have collected stool samples over 3 consecutive days. The desiccant pouch in the aluminium package should not be used.

    3 special paper strips to collect the stool samples.

    1 syringe containing 2 ml extraction liquid in a protective transparent plastic bag

    1 instructions for use.

  • PRECAUTIONS FOR USE

    1. This test is only intended for in vitro diagnostic use. For external use only. DO NOT SWALLOW.
    2. Read the instructions for use carefully before performing the test. The test can only be interpreted if the instructions are followed precisely. Adhere strictly to the specified quantities and times.
    3. Store between +4°C and +30°C. Do not freeze.
    4. Do not use after the expiry date printed on the label and on the protective bag, or if the bag is damaged.
    5. Do not reuse the FECOTEST®.
    6. Keep out of the reach of children.
    7. Important: Female users should perform the test outside of their menstrual period to prevent contamination of the samples with menstrual blood.
    8. Throw away all materials in the bin after use.

  • PROCEDURE

    Before performing the test, stool samples must be collected following the sampling procedure described below:

    A- Sample collection 
    First stool
    1. Wash your hands with soap and rinse with clean water.
    2. The stool sample is collected on the special paper strip provided. Use a new strip every day.
    3. Unscrew the cap on the syringe and dip the stick (about 2 cm) into the stool sample in 3 different places.
    4. Insert the stick covered with the stool into the tube with the solution, screw the cap on firmly, and shake. After each sample has been taken, put the tube in its plastic bag and store in the refrigerator.
    5. Flush away the paper strip used to collect the stool.
    Second stool
    Repeat steps 1 to 5.
    Third stool
    Repeat steps 1 to 5.

    B- Perform the test after collecting the 3 stools

    6. Tear open the aluminium pouch (starting from the notch) and take out just the test kit. Dispose of the bag containing the desiccant pouch.
    7. Wait for the syringe to reach room temperature before performing the test. Break off the tip of the tube. 
    8. Place the test kit on a flat surface (e.g. a table) and squeeze the body of the syringe to dispense 6 drops into the sample well. 
    9. Read the test results after 10 minutes. Do not read results after more than15 minutes.

  • READING THE RESULTS

    The colour intensity of the lines is not relevant to the interpretation of the test results.

    1. Positive result

    Two coloured lines appear in the result window under the letters T (Test) and C (Control). The colour intensity of line T may be weaker than that of line C, but this does not alter the result.

    This result indicates that blood is present in the stool and that you should see your doctor.

    2. Negative result

    One coloured strip appears under the letter C (Control). This result means that no blood could be detected in the stool.

    3. Invalid result

    Either no line or a coloured strip appears under the letter T (Test) and there is no line under the letter C. In this case, it is not possible to interpret the test, which should therefore be considered invalid. You are therefore advised to repeat the test with a new FECOTEST® and with fresh stool samples.