Testing for abnormally high levels of fecal hemoglobin is recommended by the American Cancer Society (ACS), Center for Disease Control and Prevention (CDC), and the Center for Medical Service (CMS) of the Department of Health of the United States. The fecal occult blood (FOB) rapid test has been used in the past 40 years toward this purpose.
However, screening for occult blood by means of guaiac tests has an unsatisfactory sensitivity for the detection of colorectal neoplasm in addition to a dietary restriction drawback. They also do not give any insight into the severity of bleeding in the lower gastrointestinal system. Immunochemical FOB tests dramatically increases the analytical sensitivity and specificity in the detection of human hemoglobin in feces. Several clinical trials have shown that immunochemical FOB tests are superior in clinical diagnostics sensitivity and specificity compared to guaiac FOB tests.
This q-FOB™ assay uses human hemoglobin-specific antibodies and brings significant advantages over the qualitative FOB rapid test. The assay does not require dietary restrictions to be placed on a subject or patient. This q-FOB™ assay detects human hemoglobin levels in 100-fold lower concentrations than the guaiac FOB test to avoid false-negatives. Because highly specific human hemoglobin antibodies are used, false positive results are also practically excluded.