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.
