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Helicobacter Pylori (HP) Antigen Rapid Test
Cat. No.: RH216I
The Helicobacter-Pylori antigen rapid test kit (stool) is a rapid visual immunoassay for the qualitative detection of helicobacter pylori antigen in human stool specimens. This kit is used as an aid in the diagnosis of H. pylori infection.
Helicobacter pylori (also known as Campylobacter pylori) as a spiral-shaped gram negative bacteria which infects the gastric mucosa. H. pylori to causes several gastro-enteric diseases such as non-ulcerous dyspepsia, gastric and duodenal ulcer, active gastritis and can even increase the risk of stomach adenocarcinoma.
The epidemiologic study shows that more than 50% of the world's population is infected by H. pylori strains. Infection is more prevalent in developing countries. The lowest infection rate is 20%, and the highest infection rate can be 90% in developing countries. H. pylori strains is the major reason to cause chronic gastritis and gastric ulcers, 80%-90% chronic gastritis patients and 95%-100% gastric ulcers patients are infected by H. pylori strains. So the detection and treatment of H. pylori strains infection is very important.
At present several invasive and non-invasive approaches are available to detect this infection state. Invasive methodologies require endoscopy of the gastric mucosa with histologic, cultural and urease investigation, which are expensive and require some time for diagnosis. Alternatively, non-invasive methods are available such as breath tests, which are extremely complicated and not highly selective, and classical ELISA and immunoblot assays. This Kit belongs to non-invasive approach.
This kit is designed to detect helicobacter pylori through visual interpretation of the color development in the internal strip based on the specific The membrane was immobilized with antibodies-specific on the test well (T) and corresponding antibodies on the control well(C) .
During testing, the specimen is added to the sample region (S) and reacts with anti-H. pylori antibodies conjugated to colored particles and precoated onto the sample pad of the test. Then, the mixture migrates through the membrane by capillary effect and interacts with reagents on the membrane. If there is sufficient H. pylori antigens in the specimen, a colored band will form at the test well (T) of the membrane, and this colored band indicates a positive result, while its absence indicates a negative result. A colored band at the control well(C) serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
|Individual packed test cassette||Each cassette contains a strip with colored conjugates and reactive reagents precoated at the corresponding position.||20 pieces|
|Specimen tube with extracting solution||Main Ingredients: NaCl , EDTA, sodium azide and purified Water||2ml*20|
|Package insert||For operating instruction||1pc|
MATERIALS REQUIRED BUT NOT PROVIDED
|Timer||For timing use|
STORAGE AND VALIDITY
Read the entire procedure carefully prior to testing. Keep test kit and specimen at room temperature (15-30°C) before use.
INTERPRETATION OF RESULTS
POSITIVE RESULT: Two colored bands appear on the membrane. One band appears in the control well (C) and another band appears in the test well (T). Positive result indicates the specimen with helicobacter pylori antigen.
NEGATIVE RESULT: Only one colored band appears in the control well (C). No apparent colored band appears in the test well (T).Negative result indicates the specimen without helicobacter pylori antigen
INVALID RESULT: Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat the test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
The intensity of the color in test well (T) may vary depending on the concentration of aimed substances present in the specimen. But in the valid time, even the color band is very week, the result shall be regarded as positive.
LIMITATIONS OF THE TEST
Cross reactivity with the following organisms. The following organisms produced negative results when testing with the One Step Helicobacter-Pylori Antigen Test Kit (stool)
|Candida albicans (ATCC10231)||Candida tropicalis (ACCC20005)||Candida parapsilosis (ACCC20221)|
|Proteus mirabilis (CMCC49005)||Streptococcus Faecium (ATCC29212)||Staphylococcus aureus (ATCC6538)|
|Pseudomonas aeruginosa (ATCC9027)|
Span Biotech Ltd. is a research based company for rapid tests, with strong support from National Key Laboratory of Technology Projects of 10th and 11th Five-Year Plan and Faculty of Life Sciences of HuBei University. SpanBio also housed a R&D team that is developing gene recombination, cell cultivation and protein purification techniques. SpanBio pays strict attention on rapid tests for human being, animal diseases and food safety detection. It provides a number of customized services to professional distributors and partnering affiliates with excellent quality, competitive prices and super service.
Contact Person: Ms. Anna Lee