FOB Rapid Test Device is an immunochromatographic in vitro assay for qualitative determination of human hemoglobin in feces. Hemoglobin in feces is an indication of internal bleedings associated with pathological conditions of gastrointestinal tract such as colon polyps, colorectal carcinoma, ulcerative colitis, and crohn's disease
 
Colorectal cancer is the third most common cancer in the world.  "Fecal occult blood" is generally defined as a blood loss of less than 50 ml/d.  The appearance of occult blood in human fecal specimen is often associated with gastrointestinal diseases, which might cause colorectal cancer if not treated promptly and properly. Traditional guaiac-based method lacks sensitivity and specificity, and has diet restriction prior to testing.  
 
FOB Rapid Test Device uses technology of lateral flow double antibody sandwich assay.  The test is more sensitive and more specific than the traditional guaiac assay does.  It is easier to interpret the result.  In addition, unlike the guaiac assays, the accuracy of the test is not affected by the diet of the patients.
 
FOB Rapid Test Device is composed of two units, a fecal collection tube and a test device.  Fecal specimen is collected in the collection tube containing sample extraction buffer and then added to the test device.  When the sample is added to sample pad, it moves through the conjugate pad and mobilizes gold anti-human hemoglobin antibody conjugate that is coated on the conjugate pad.  The mixture moves along the membrane by capillary action and reacts with anti-human hemoglobin antibody that is coated on the test region.  If hemoglobin is present of 50ng/ml or greater, the result is the formation of a colored band in the test region.  If there is no hemoglobin in the sample, the test area will remain colorless.  The sample continues to move to the control area where Goat anti-mouse IgG antibody will capture gold-sample antibody conjugate to form a pink to purple color, indicating the test is working and the result is valid.