Intended Use; Clinical Background - Biohit ColonView Hb/Hp Test Instructions D'utilisation

1. INTENDED USE

ColonView Hb/Hp Fecal Occult Blood Test is a visual, immuno-
chromatography quick test for the qualitative detection of human
hemoglobin/haptoglobin complex (Hb/Hp) in stool samples. For
professional, in vitro diagnostic use.

2. CLINICAL BACKGROUND

ColonView Hb/Hp Fecal Occult Blood Test (FOB) test was de-
signed to aid diagnosis of lower GI 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 (1-2). Screening for colorectal
cancer probably increases the cancer detection rate at an early
stage, therefore reducing the mortality (3-5).
Earlier commercially available FOB tests utilized the guaiac test,
which requires special dietary restriction to minimize false positive
and false negative results. ColonView Hb/Hp tests are specially
designed to detect human Hb/Hp in stool samples using immu-
nochemical methods, which improved specificity for the detection
of lower GI disorders, including colorectal cancers and adenomas
(6-10).
A molecule of Hb consists of 2 pairs of peptide (alpha and beta
globins) chains and four heme groups, each with one atom of
iron. Free Hb may separate into alpha-beta molecules, which are
bound to a protein called haptoglobin. Hb/Hp complex plays an im-
portant role in the retrieval of hemoglobin from lyzed erythrocytes
and is relatively stable against acid and proteolytic degradation.
Therefore the Hb/Hp complex can be detected even after longer
passages through the bowel. This means that blood caused by
larger intestinal polyps and higher carcinomas can also be de-
tected. Detection of the Hb/Hp complex displays a significant in-
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