| Customization: | Available |
|---|---|
| Type: | IVD Reagent |
| Certificate: | CE, ISO |
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Intended Use
The H. pylori Antigen Rapid Test (Feces) is a rapid visual immunoassay for the qualitative presumptive detection of Helicobacter pylori antigens in human fecal specimens. This kit is intended to be used as an aid in the diagnosis of H. pylori infection.
Introduction
Helicobacter pylori (also known as Campylobacter pylori) is a spiral-shaped with a typical flagellum, Gram negative bacteria, infecting gastric mucosa. It 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, so as to be classified as carcinogen agent type I.
At present several invasive and non-invasive approaches are available to detect this infection state. Invasive methodologies requires endoscopy of the gastric mucosa with a histologic, cultural and urease investigation, which are cost-effective and requiring long times to come to a correct final diagnosis.
Alternatively, non-invasive methods are available such as Breath Test, which is extremely complicated and not highly selective, or classical ELISA and immunoblotting assays.
Method
The H. pylori Antigen Rapid Test (Feces) has been designed to detect Helicobacter pylori through visual interpretation of color development in the internal strip. The membrane was immobilized with anti-H. pylori monoclonal antibody on the test region. During the test, the specimen is allowed to react with colored anti-H. pylori monoclonal antibody colloidal gold conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interact with reagents on the membrane. If there were enough H. pylori antigens in specimens, a colored band will form at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.
Main Contents
• One pouch containing a rapid test cassette with desiccant
• Specimens dilution tube with buffer
• Package insert
Storage Condition
• Store at 2 ~ 30 º C in the sealed pouch for 24 months.
• Keep away from direct sunlight, moisture and heat.
• DO NOT FREEZE.
| Product Name | Cat# | Method | Accuracy | Lead Time | Certification |
| H.Pylori Antigen Rapid Test | HP-DF02 | Colloidal Gold | 99.9% | 5-20 work days | CE, ISO |
Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.
1. Specimen collection and pre-treatment:
1) Best results will be obtained if the assay is performed within 6 hours after collection.
2) Unscrew and remove the dilution tube applicator stick. Be careful not to spill or spatter solution from the tube. Collect specimens by inserting the applicator stick into at least 4 different sites of the feces to collect approximately 50 mg of feces (equivalent to 1/4 of a pea).
3) Place the applicator stick back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.
4) Shake the specimen collection tube vigorously to mix the specimen and the extraction buffer.
2. Testing:
1) Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. To obtain a best result, the assay should be performed within one hour.
2) Using a piece of tissue paper, break the tip of the dilution tube. Hold the tube vertically and dispense 2-3 drops of solution into the specimen well (S) of the test device. Avoid trapping air bubbles in the specimen well (S), and do not drop any solution in observation window. As the test begins to work, you will see color move across the membrane.
3. Wait for the colored band(s) to appear. The result should be read in 15 minutes.
4. Results reading.
1) POSITIVE: The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.
2) NEGATIVE: The presence of only control line (C) within the result window indicates a negative result.
3) INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid.
Rapid • Accurate • Simple
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