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RAPID HELICOBACTER PYLORI ANTIGEN TEST
Immunochromatographic rapid assay for the Detection of Helicobacter pylori Antigens in Human Stool Specimens
INTENDED USE:
Rapid H. pylori Antigen Test is an in vitro qualitative immunochromatographic assay for the rapid detection of Helicobacter pylori antigens in human stool specimen. The test results are intended to aid in the diagnosis of H. pylori infection, to monitor the effectiveness of therapeutic treatment and to confirm the eradication of H. pylori in peptic ulcer patients.
SPECIFICATION:
1) Specimen: feces
2) Format: cassette
3) Accuracy: 97.5%
FEATURE:
1) Simple: simply add specimen and dilution(if necessary) into sample well
2) Rapid: results come out within 15 minutes
3) Visually interpreted: don’t need any equipment
4) Stable: more than 12 month period of validity
PACKING
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) Hold the sample bottle upright with the tip point toward the direction away from the test performer, snap off the tip.
4) Hold the bottle in a vertical position over the sample well of the test card, deliver 3 drops ( 120 -150 μL ) of diluted stool sample to the sample well.
5) Read the result within 15 minutes. A strong positive sample may show result earlier.
PRINCIPLE:
Rapid H. pylori Antigen Test is a sandwich solid phase immunochromatographic assay. To perform the test, an aliquot of diluted stool sample is added to the sample well of the test cassette. The sample flows through a label pad containing H. pylori antibody coupled to red-colored colloidal gold. If the sample contains H. pylori antigens, the antigen will bind to the antibody coated on the colloidal gold particles to form antigen-antibody-gold complexes. These complexes move on the nitrocellulose membrane by capillary action toward the test line region on which H. pylori specific antibodies are immobilized. As the complexes reach the test line, they will bind to the antibody on the membrane in the form of a line. A second red control line will always appear in the result window to indicate that the test has been correctly performed and the test device functions properly. If H. pylori antigen is not present or lower than the detection limit of the test, only the control line will be visible. If the control line dose not developed, the test is invalid.
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