H. Pylori rapid Test Cassette
For the qualitative detection of Antibodies to H. Pylori in serum
/plasma and whole Blood
Main Features
☀ High Sensitivity
☀ High Specificity
☀ Reliable: high accurate, early detection of the presence of
H.Pylori
☀ Simple: No Instrument Required
☀ Convenient: Room Temperature Storage, Built-In Control line
☀ Fast: Results in 5-30 minutes, strong positive results may be
observed promptly within 3 minutes
☀ Certified by Authoritative Certification System and Standards
☀Winner of "the National Rapid Diagnostic Kit for Clinical
Performance Assessment"
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.
Principle
The H. pylori Rapid Test is a lateral flow,
immunochromatographic-screening test. H. pylori antigens are
precoated onto membrane as a capture reagent on the test band
region. During the assay the specimen serum is allowed to react
with H. pylori antigens-gold conjugate. The mixture then moves
laterally on the membrane chromatographically to the test region
with immobilized antigens of H. pylori. If H. pylori antibodies 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.
Reagents and Materials Provided
1. One pouched cassette with desiccant.
2. One bottle of diluent buffer.
3. Instruction for use.
Materials Required But Not Provided
1. Clock or timer
2. Specimen collection tube
Warning and Precautions
1. For in vitro diagnostic use only.
2. All patient samples should be treated as if capable of
transmitting diseases.
3. Do not interchange reagents from different lots or use test kit
beyond expiration date.
4. 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).
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.
