Intended Use - Gima 24530 Bedienungsanleitung

A rapid, one step test for the qualitative detection of Human Occult Blood in feces. For professional in
vitro diagnostic use only.
The FOB One Step Fecal Occult Blood Test Device (Feces) is a rapid chromatographic immunoassay
for the qualitative detection of Human Occult Blood in feces.
Many diseases can cause hidden blood in the feces. This is also known as Fecal Occult Blood (FOB),
Human Occult Blood, or Human Hemoglobin. In the early stages, gastrointestinal problems such as
colon cancer, ulcers, polyps, colitis, diverticulitis, and fissures may not show any visible symptoms,
only occult blood. Traditional guaiac-based methods lack sensitivity and specificity, and also have diet
restrictions prior to testing.
to qualitatively detect low levels of Fecal Occult Blood. The test uses a double antibodysandwich
assay to selectively detect Fecal Occult Blood at 50 ng/mL or higher, or 6 µg/g feces. In addition,
unlike guaiac assays, the accuracy of the test is not affected by the diet of the patients.
The FOB One Step Fecal Occult Blood Test Device (Feces) is a qualitative, lateral flow immunoassay
for the detection of Human Occult Blood in feces. The membrane is pre-coated with anti-hemoglobin
antibody on the test line region of the test. During testing, the specimen reacts with the particle coated
with anti-hemoglobin antibody. The mixture migrates upward on the membrane chromatographically
by capillary action to react with anti-hemoglobin antibody on the membrane and generate a colored
line. The presence of this colored line in the test line region indicates a positive result, while its absence
indicates a negative result. To serve as a procedural control, a colored line will always appear in the
control line region, indicating that the proper volume of specimen has been added and membrane
wicking has occurred.
The test contains anti-hemoglobin antibody particles and anti-hemoglobin antibody coated on the
membrane.
• For professional in vitro diagnostic use only. Do not use after expiration date.
• The test must remain in the sealed pouch until use.
• Do not eat, drink or smoke in the area where the specimens or kits are handled.
• Do not use test if pouch is damaged.
• Handle all specimens as if they contain infectious agents. Observe established precautions against
microbiological hazards throughout the testing and follow standard procedures for proper disposal of
specimens.
• Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens
are being tested.
• The used test should be discarded according to local regulations.
• Humidity and temperature can adversely affect results.
One Step Fecal Occult Blood Test Device (Feces)

INTENDED USE

SUMMARY
The FOB One Step Fecal Occult Blood Test Device (Feces) is a rapid test
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PRINCIPLE
REAGENTS
PRECAUTIONS
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