Indications for Use

Reese’s ColoTest® Immunochemical Fecal Occult Blood Test is a qualitative immunoassay for detection of fecal occult blood. Fecal occult blood is blood in your stool. It is intended for professional and over the counter use.

Warnings & Precautions

  1. For In Vitro Diagnostic Use
  2. Bleeding in the digestive systems may be intermittent (not continuous). If concerned, it is recommended to perform the test on three different days with new feces samples each time to increase the chance of detecting fecal occult blood.
  3. Hands and test area should be kept clean and free from blood to avoid contamination.
  4. Treat fecal samples and used test materials as if they are potentially infectious by using gloves and dispose according to federal, state, and local requirements.
  5. Taking Aspirin or nonsteroidal anti-inflammatory medications may cause bleeding in your digestive system and may make the FOB test positive.
  6. Keep the kit and test components out of the reach of children.
  7. Do not use an expired device.

Limitations of the Test

  1. This test is for testing human fecal samples only and loose stool samples have not been validated for this device to provide accurate results.
  2. This test is not used to diagnose a condition or to replace other diagnostic procedures.
  3. A positive result should be confirmed by a physician with additional confirmatory diagnostic procedures.
  4. Occasionally, a negative result may be obtained even when a gastrointestinal disorder is present. For example, some polyps and colorectal cancers may bleed intermittently or not at all during certain stages of the disease.
  5. Negative results may also occur when occult blood is not uniformly distributed throughout the bowel movement and the formation of a fecal sample. Repeat testing if a pathological condition is suspected.
  6. Limit assay reading time to 1-10 minutes.
  7. Specimen should not be collected or used with the following conditions that may interfere with the test results:

    A. Menstrual bleeding
    B. Bleeding hemorrhoids
    C. Constipation bleeding
    D. Urinary bleeding

Important Risk Information

ColoTest® should not be used if you:

  • Have a history of colorectal cancer or other related cancers
  • Had a positive result from another colorectal cancer screening test within the last 6 months
  • Have a condition that places you at high risk for colorectal cancer, including Inflammatory Bowel Disease (IBD) or certain hereditary syndromes or a family history of colorectal cancer

Talk to your healthcare provider if any of these situations apply to you.

Your ColoTest® result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Many conditions may cause blood in your stool. Patients with a positive test result should contact their physician for next steps, likely including a colonoscopy.

A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their healthcare provider when they need to be tested again. ColoTest® is an annual stool screening method for colorectal cancer.

For more information on ColoTest®, please click here.

Please read all instructions before using the test.