Catalog # 750720 – 20 tests

Description

Rapid 5 minutes immunoassay, based on a lateral flow chromatography technique using a monoclonal antibody, for the qualitative detection of Helicobacter pylori Antigens in human stool.

The Premier Platinum HpSA, a microtiter assay from Meridian Bioscience, after extensive evaluation, was accepted as an accurate tool for non-invasive Helicobacter pylori infection diagnosis. This single test format provides new flexibility to the Helicobacter pylori Stool Antigen testing. It is the convenient choice when testing a limited number of specimens and a simpler procedure is desired.

Unlike serological tests, the detection of H.pylori stool antigens is able to identify current infections, using a truly non-invasive method, and can be used for diagnosing the infection, as well as for confirming the eradication four weeks after the end of the therapy.

Features

-          One-step single test

-          5 minutes room temperature incubation

-          Internal procedure control

Specimen handling

The stool specimen, collected in an empty container, can be stored up to 3 days at 2-8°C before testing. If testing is not performed within this time frame, specimens should be frozen upon receipt (-20°C to –80°C).

Kit Components

Test cards (20), Sample Diluent vials (20), Positive Control, Transfer Pipettes.

Test Procedure

1. Using the applicator stick of the diluent vial, transfer a small portion (5-6 mm diameter) of stool specimen into the sample diluent.  Vortex 15 seconds.

2. Hold the vial and break the tip off.

3. Dispense 4 drops into the round window at the lower end of the device and read the result after 5 minutes.

Interpretation of Results

Negative: one BLUE line (control)

Positive: one BLUE line (control) and one PINK-RED line (test).

Storage

The kit must be stored at 2-8°C.

Performance

The ImmunoCard STAT! HpSA provides an accuracy comparable to Premier Platinum HpSA. In an evaluation including 104 patients undergoing endoscopy, the sensitivity and the specificity resulted 96 and 91 respectively, compared to biopsy based tests.

The stool antigen test is recommended by the Maastricht 2000 consensus guidelines for non-invasive diagnosis and therapy follow-up test.

Additional Information

Click here for more information (complete procedure, safety data sheet, literature).