H. Pylori Antigen Detection Test Kit

For the qualitative detection of Antigens to H. Pylori in feces

Intended Use

The H. pylori Rapid Test is a chromatographic immunoassay (CIA) for the rapid determination of antigens to H. pylori in stool specimens. The test is to be used as an aid in the diagnosis of infection due to H. pylori.

The infection of Helicobacter pylori (H.pylori) is associated with a variety of gastro-intestinal diseases, such as stomach ulcer, chronic active gastritis and gastric, duodenal and gastric adenocarcinoma. Detecting these specific antigens to H. pylori can be use as a qualitative assay in the diagnosis of H. pylori infection. It may be used either as an adjunction to endoscopy or as an alternative measure in symptomatic patients.

Principle

The H.pylori Rapid Test is a lateral flow, immunochromatographic-screening test. H. pylori antibodies are precoated onto membrane as a capture reagent on the test band region.

During the assay the specimen is allowed to react with H. pylori antibodies-gold conjugate. The mixture then moves laterally on the membrane chromatographically to the test region with immobilized antibodies of H. pylori.

If H. pylori antigens are present in the specimen, two colored bands are formed on the test region. One colored band in the test region indicates a negative result.

Sample Collection and Preparation

1. Collect stool sample by using the sample collection device provided.

2. Unscrew the top of the sample collection device, take out the sample collection stick, and collect the sample by dipping the stick into 3 different places of the stool sample.

3. Put the sample collection stick back in the sample collection device and screw together tightly.

4. If the sample cannot be tested on the day of collection, store the stool sample at 4°C. Bring the specimen to room temperature before testing.

Assay Procedure

1. Remove the test device from foil pouch by tearing along the notch.

2. Specimen collection. Please see also SPECIMEN COLLECTION

3. Shake the sample collection device several times.

4. Holding the sample collection device upright, carefully screw off the cap of collection device.

5. Squeeze 2-3 drops (80-100ul) of the sample solution on the test sample pad.

6. Observe the result in 15 minutes. Don’t read result after 15 minutes. To avoid confusion, discard the test device after interpreting the result.

Interpretation of Results

Negative:

Only one pink band appears. This indicates that no H. pylori antibodies have been detected.

Positive:

Two pink bands appear. This indicates that the specimen contains H. pylori antibodies.

Invalid:

If no band appears, this indicates a possible error in performing the test. The test should be repeated using a new device.