FDA Whole blood Helicobacter Pylori Ab Test Cassette

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.