FECAL OCCULT BLOOD (FOB) TEST

For the qualitative assessment of human hemoglobin in feces

INTENDED USE

The Fecal Occult Blood test is a qualitative test that detects human hemoglobin in human fecal specimens. The test is a visual one step, in-vitro assay. It is intended for professional use to help diagnose gastrointestinal bleeding.

SPECIFICATION:

1)        Specimen: feces

2)        Format: strip/cassette

3)        Sensitivity: 50 ng/ml

FEATURE

1)        Simple: simply add specimen into sample well

2)        Rapid: results come out between 5 and 10 minutes

3)        Visually interpreted: don’t need any equipment

4)        Stable: more than 12 month period of validity

PACKING

1)        Strip: 100 tests/box

2)        Cassette: 25 tests/box, 50 tests/box

PROCEDURE:

1)        Bring all materials and specimens to room temperature (8–30ºC).

2)        Remove the test card from the sealed foil pouch.

3)        Shake the collection tube vigorously to ensure a good liquid suspension.

4)        Holding the tube upright with tip pointed toward the direction away from the test performer; snap off the tip.

5)        Hold the tube in a vertical position over the sample well of the test card and deliver 3 drops (120-150 mL) of sample into the sample well.

6)        Read the result between 3 and 10 minutes.

PRINCIPLE:

The Fecal Occult Blood Test is composed of two units, a fecal collection tube and a test device. A fecal specimen is collected in the collection tube containing sample extraction buffer, and then added to the test device. When sample is added to sample pad, it moves through the conjugate pad and mobilizes the gold anti-h hemoglobin antibody conjugate that is coated on the conjugate pad. The mixture moves along the membrane by capillary action and reacts with anti-h hemoglobin antibody that is coated on the test region. If hemoglobin is present at levels of 50 ng/mL or greater, the result is the formation of a colored band in the test region. If there is no h hemoglobin in the sample, the area will remain colorless. The sample continues to move to the control area where goat anti-mouse IgG antibody will capture gold-antibody conjugate to form a pink to purple color, indicating the test is working and the result is valid.