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.