H.Pylori antigen & antibody rapid test kits

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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. RAPID HELICOBACTER PYLORI ANTIBODY TEST Immunochromatographic rapid assay for the Detection of Helicobacter pylori Antibody in Human whole blood, serum or plasma INTENDED USE: Rapid H. Pylori Antibody Test is a rapid immunochromatographic assay for the detection of antibodies to H. pylori in human whole blood, serum or plasma. The assay is to provide an aid in diagnosis of H. pylori infection. SPECIFICATION: 1) Specimen: whole blood/serum/plasma 2) Format: cassette FEATURE: 1) Simple: simply add specimen and dilution(if necessary) into sample well 2) Rapid: results come out at10 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 the kit components to room temperature before testing. 2) Open the pouch and remove the Card. Once opened, the test card must be used immediately. 3) Label the test card with patients identity. 4) Apply 3 drops (120-150 μL) of serum, plasma or whole blood to the sample well marked as “S’. 5) At the end of 10 minutes read the results. A strong positive sample may show result earlier. PRINCIPLE: Rapid H. Pylori Antibody Test employs chromatographic lateral flow test device in a cassette format. Colloidal gold conjugated H. pylori antigens (Au-Ag) are dry-immobilized at the end of nitrocellulose membrane strip. H. Pylori antigens are bond at the Test Zone (T) When the sample is added, it migrates by capillary diffusion rehydrating the gold conjugate. If anti-H. pylori antibodies present in sample, Antibodies will bind with the gold conjugated antigens forming particles. These particles will continue to migrate along the strip until the Test Zone (T) where they are captured by H. pylori antigens generating a visible red line. If there are no anti-H. Pylori antibodies in sample, no red line is formed in the Test Zone (T). A built-in control line will always appear in the Control Zone (C) when the test has performed properly, regardless of the presence or absence of anti-H. pylori antibodies in the specimen.

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Boson Biotechnology Co,.Ltd.

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