Description
Fob Measurement of Fecal Occult Blood
Fecal Occult Blood Test FOB MonlabTest® is a rapid, visual immunochromatographic test for the qualitative detection of human blood hemoglobin in fecal samples. This test is intended as an aid in the diagnosis of lower gastrointestinal (g.i.) disorders. The test is recommended for professional use.
The primary use of FOB MonlabTest® is to screen for lower g.i. pathologies, such as colorectal cancers and large adenomas that bleed. Colorectal cancer is one of the most commonly diagnosed cancers and a leading cause of cancer death in the United States. Screening for colorectal cancer probably increases the cancer detection at an early stage, therefore reduces the mortality. Earlier commercially available FOB MonlabTest® utilized the guaiac test, which requires special dietary restriction to minimize false positive and false negative results. MonlabTest® are specially designed to detect human samples using immunochemical methods, which improved specificity for the detection of lower g.i. disorders, including colorectal cancers and adenomas.
What is the FOB MonlabTest® used for?
The primary use of FOB MonlabTest® is to screen for lower g.i. pathologies, such as colorectal cancers and large adenomas that bleed. Colorectal cancer is one of the most commonly diagnosed cancers and a leading cause of cancer death in the United States. Screening for colorectal cancer probably increases the cancer detection at an early stage, therefore reduces the mortality. Earlier commercially available FOB MonlabTest® utilized the guaiac test, which requires special dietary restriction to minimize false positive and false negative results. MonlabTest® are specially designed to detect human samples using immunochemical methods, which improved specificity for the detection of lower g.i. disorders, including colorectal cancers and adenomas.
Fecal Occult Blood Test FOB, REAGENTS AND MATERIALS SUPPLIED
- Individually wrapped test cassette. Each test cassette contains one test strip with anti-human hemoglobin monoclonal antibody coated membrane and colored anti-human hemoglobin monoclonal antibody pad.
- Sample Collection Tubes: Each contains 2ml of 0.9% NaCl with 0.02% sodium azide.
- Test instruction.
MATERIALS REQUIRED BUT NOT SUPPLIED
- A clean dry container or receptacle for the collection of fecal sample.
- A piece of tissue paper to prevent solution from splashing
Test Procedure
Review “Specimen Collection” instructions. Test cassette, patient’s samples, and controls should be brought to room temperature (10 -30ºC) prior to testing. Do not open pouches until ready to perform the assay.
• Remove the test cassette from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour. Remove the test cassette from its protective pouch (bring the cassette to room temperature before opening the pouch to avoid condensation of moisture on the membrane). Label the cassette with patient or control number.
• Shake the collection tube thoroughly to ensure proper mixing of the fecal sample with the extraction solution.
• Using a piece of tissue paper, break the tip of the collection tube using a twisting motion. Hold the collection tube vertically and dispense 2~3 drops (about 90-135µl) of solution into the sample well of the test cassette.
• Observe the result in 5 minutes. Strong positive results may be observed sooner. Do not interpret after 8 minutes.
Interpretation of results

Two red lines are visible in the control (“C”) and test (“T”) region of the test window. The intensity of the test line may be less than that of the control line; this still means positive result.

The control line appears in the test window, but the test line is not visible.

The test is invalid if the control line is not visible at five minutes. The test failed, or the test procedure was not followed properly. Verify the test procedure and repeat the test with a new testing cassette.