The StrongStep® FOB Rapid Test Strip (Feces) is a rapid visual immunoassay for the qualitative presumptive detection of human hemoglobin in human fecal specimens. This kit is intended to be used as an aid in the diagnosis of lower gastrointestinal (g.i.) pathologies.
INTRODUCTION
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 tests utilized the guaiac test, which requires special dietary restriction to minimize false positive and false negative results. The FOB Rapid Test Strip (Feces) are especially designed to detect human hemoglobin in fecal samples using Immunochemical methods, which improved specificity for the detection of lower gastrointestinal. disorders, including colorectal cancers and adenomas.
PRINCIPLE
The FOB Rapid Test Strip (Feces) has been designed to detect human hemoglobin through visual interpretation of color development in the internal strip. The membrane was immobilized with anti-human hemoglobin antibodies on the test region. During the test, the specimen is allowed to react with colored anti-human hemoglobin antibodies colloidal gold conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interact with reagents on the membrane. If there were enough human hemoglobin in specimens, a colored band will form at the test region of the membrane. Presence of this colored band indicates a positive result,