HP H Pylori Antigen Rapid Test Cassette Immunochromatography Feces Specimen CE ISO

Brand Name:Dewei
Certification:CE, ISO
Model Number:HP-DF02
Minimum Order Quantity:5000 Tests
Delivery Time:in 20 working days
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HP H.Pylori Rapid Test Cassette Immunochromatography (Feces Specimen) CE ISO


【H. Pylori 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.
Many H. pylori strains have been isolated: among them, the strain expressing CagA antigen is strongly immunogenic and, according to this, it is of utmost clinical importance because it is associated to the cytotoxic factor. It is widely reported in many literature articles that, in infected patients showing antibodies against CagA gene product, the risk of gastric cancer is up to five times higher than the reference group infected with a CagA negative bacterial strain.
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 require 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.

【H. pylori Ag RAPID TEST 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.
Product NameCat#Result timeSpecimenCertificates
H.Pylori AntigenHP-DF0215 MINSFecesCE, ISO13485

【MAIN CONTENTS】

One pouch containing a rapid test cassette with desiccant.
Specimens dilution tube with buffer
Package insert

【PRECAUTIONS】
 For professional in vitro diagnostic use only.
 Do not use after the expiration date indicated on the package. Do not use the test if the foil pouch
is damaged. Do not reuse tests.
 Used testing materials should be discarded according to local regulations

【H. pylori Ag DIRECTION OF USE】

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 3 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 (80-100 μL) 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.
Note: If the specimen does not migrate (presence of particles), centrifuge the extracted specimens contained in the extraction buffer vial. Collect 80 µL of supernatant, dispense into the specimen well(S) of a new test device and start afresh following the instructions mentioned above.

【INTERPRETATION OF RESULTS】
POSITIVE:
The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.
NEGATIVE:
The presence of only control line (C) within the result window indicates a negative result.
INVALID:
If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.

【DETAILED PHOTO】


FRQ:

1What is the cause of H pylori infection?H. pylori bacteria are usually passed from person to person through direct contact with saliva, vomit or stool. H. pylori may also be spread through contaminated food or water. The exact way H. pylori bacteria causes gastritis or a peptic ulcer in some people is still unknown.
2What are the signs and symptoms of H. pylori?H. pylori is a bacteria that can cause peptic ulcer disease and gastritis. It mostly occurs in children. Only 20% of those infected have symptoms. Symptoms include dull or burning stomach pain, unplanned weight loss and bloody vomit.
3Can H. pylori be cured completely?In some cases, H pylori can't be cured with any therapy, though the symptoms may be able to be reduced. If cured, reinfection may occur in areas where sanitary conditions are poor.
4How serious is H pylori infection?It can damage the tissue in your stomach and the first part of your small intestine (the duodenum). This can cause pain and inflammation. In some cases, it can also cause painful sores called peptic ulcers in your upper digestive tract. H. pylori is common.
5What do bowel movements look like with H. pylori?pylori infection, you might have blood in your stool. In most cases, the blood appears very dark — almost black. Your stools might have a tarry appearance or consistency. If you have bloody stools, you should call our office right away so we can get any bleeding under control.
6What not to eat when you have H. pylori?Citrus fruits such as lemons and pineapple can increase stomach acid and cause pain and heartburn. Spicy foods. Spicy or acidic foods like garlic, mustard and pepper can all have a negative effect on people with H.
7What is the fastest way to cure H. pylori?Ulcers caused by H. pylori are usually treated with a combination of antibiotics and a proton pump inhibitor (PPI). Triple therapy: Therapies that combine PPIs with two antibiotics remain the first-line options for treating H. pylori.
8What is the first stage of H. pylori?Although a staging system for the H pylori infection does not exist, some steps in the disease process are well described. The first step is chronic gastritis, followed after a time by the second step, atrophic gastritis. The third step is intestinal metaplasia, which may evolve into dysplasia.
9What happens if you test positive for H. pylori?A positive test result means that you have an H. pylori infection. Your provider will usually prescribe one or more antibiotics to treat the infection. You will usually take other medicines to relieve your symptoms and help heal your stomach.
10How contagious is H. pylori?H. pylori is commonly transmitted person-to-person by saliva. The bacteria can also be spread by fecal contamination of food or water. In developing countries, a combination of untreated water, crowded conditions, and poor hygiene contributes to higher H.
11Can your body get rid of H. pylori by itself?The almost invincible human immune system fails to eliminate H. pylori because of successful immune evasion strategies and also because of the complex intrinsic genetic variability adopted by this bacterium.
12Which probiotic kills H. pylori?pylori treatment reveals that single-strained probiotics, particularly those containing Lactobacillus spp., Bifidobacterium spp., and Saccharomyces spp. are more commonly used. These probiotics have shown promise in increasing the success rate of H. pylori eradication and in mitigating side effects.
13Can stress cause H. pylori?Certain health and lifestyle factors increase the risk of damage to the stomach and intestinal lining. These factors make it more likely that a person will develop an ulcer, including a stress-related ulcer: H. pylori infection.
14What is the natural killer of H. pylori?In human studies , daily consumption of broccoli sprouts reduced H. pylori colonization and gastric inflammation, with some cases resulting in complete eradication of the bacteria.
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HP H Pylori Antigen Rapid Test Cassette Immunochromatography Feces Specimen CE ISO

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