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Helicobacter Pylori INTENDED USE
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 INTRODUCTION
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.
Helicobacter Pylori PRINCIPLE
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.
Helicobacter Pylori PERFORMANCE CHARACTERISTICS
1. Positive Coincidence Rate:100%
2. Negative Coincidence Rate:100%
3. Analytical Specificity:
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) Escherichia coli (ATCC8739) Pseudomonas aeruginosa (ATCC9027)
4. Analytical Sensitivity: The result is positive when testing with 150ng HP antigen/ml dilution.
5. Intra-batch Discrepancy: The test results are the same in one batch
6. Inter-batch Discrepancy: The test results are the same in different batch
7. Comparison: Compared with other famous branded H. Pylori Antigen Test Kit, the coincidence rate is 91.8%, and the clinical coincidence rate is 94.6%
8. Anti-interference Performance: No interference by human hemoglobin 1000mg/dl and Animal hemoglobin 2000mg/dl
Helicobacter Pylori PRECAUTIONS
For disposable use only
For professional in vitro diagnostic use only.
The specimen dilution buffer contains sodium azide which may react with lead or copper plumbing to form
potentially explosive metal azides. Do not drink or smell it.
Do not use the devices when the package damaged
Do not interchange or mix reagents from different lots
Do not use after the expiration date indicated on the package
Do not touch membrane before us
After completing assay, dispose the test kit and tube carefully after autoclaving them at 121°C for at least 20mintues. Or treat them with 0.5% sodium hypochloride for 40-60 minutes, or burn them.
Contact Person: Ms. Anna Lee