H. Pylori rapid Test Cassette

For the qualitative detection of antibodies to H. Pylori in serum /plasma and whole blood

Home Use H.Pylori Rapid Test Kit High Precision Detection Cassette For Helicobacter Pylori

Intended Use

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. Antibodies to H. pylori are developed in individuals infected with H. pylori as a serological response. Detecting these specific antibodies 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.

The H. pylori Rapid Test is a chromatographic immunoassay (CIA) for the rapid determination of antibodies to H. pylori in serum/plasma/whole blood specimens. The test is to be used as an aid in the diagnosis of infection due to H. pylori.

Reagents and Materials Provided

☀ One pouched cassette with desiccant.

☀ One bottle of diluent buffer.

☀ Instruction for use.

Materials Required But Not Provided

☀ Clock or timer

☀ Specimen collection tube

Assay Procedure

Serum/Plasma
Add 70-100 ul or 2-3 drops serum or plasma into sample well. Observe the result in 10-15 minutes.

Whole blood
Add 1 drop of whole blood into sample well, after all blood completely absorbed, add 1 drop of whole blood diluent. Observe the result in 10-15 minutes. add 1 drop of diluent. Observe the result in 5-15 minutes.

Warning and Precautions

☀ For in vitro diagnostic use only.

☀ All patient samples should be treated as if capable of transmitting diseases.

☀ Do not interchange reagents from different lots or use test kit beyond expiration date.

☀ Icteric, lipemic, hemolysis, heat treated and contaminated sera may cause erroneous results.

Storage

Store the test kits at temperature 4-30°C,in the sealed pouch for the duration of the shelf life (24 months).

Summary and Explanation of The Test

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. Antibodies to H.pylori are developed in individuals infected with H. pylori as a serological response. Detecting these specific antibodies to H. pylori can be used 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.

The H. pylori Rapid Test is a chromatographic immunoassay (CIA) for the rapid determination of antibodies to H. pylori in serum /plasma and whole blood specimens. The test is to be used as an aid in the diagnosis of infection due to H. pylori.