Whole Blood In Vitro Diagnostic FDA H Pylori Rapid Test Kit

Product Specification

H. Pylori rapid Test Cassette

For the Qualitative Detection of Antibodies to H. Pylori in serum /plasma and whole blood

One Step Helicobacter Pylori Rapid Diagnostic Kit High Accurate Detection Kit

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.

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.

Materials Required But Not Provided

☀ Clock or timer

☀ Specimen collection tube

Reagents and Materials Provided

☀ One pouched cassette with desiccant.

☀ One bottle of diluent buffer.

☀ Instruction for use.

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.

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.

Storage

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

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.