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7 ChemtrueTM One-Step FOB Test 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.

7 The primary use of One-Step FOB Test 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 One-Step FOB Tests utilized the guaiac test, which requires special dietary restriction to minimize false positive and false negative results. ChemtrueTM One-Step FOB Tests are specially designed to detect human hemoglobin in fecal samples using immunochemical methods, which improved specificity for the detection of lower g. i. disorders, including colorectal cancers and adenomas.