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Medical H.pylori antigen rapid test - INC-312

Medical H.pylori antigen rapid test, 1)specimen:stool., 2)reading time:10 min, 3)MOQ is 1000pcs - more info check here: http://www.sourcingappliances.com/Medical-H-pylori-antigen-rapid-test-30137718/

Quick Brief

Place of Origin: Guangdong China (Mainland) Brand Name: GEMINOL Model Number: INC-312 sensitivity: 95% specificity: 95.7% format: strip reading time: 10 min specimen: stool MOQ: 1000pcs delivery time: 7-14 days package: neutral pouch bulk package

Product Features:

Medical H.pylori antigen rapid test

1)specimen:stool.

2)reading time:10 min

3)MOQ is 1000pcs

Business Terms:

Price Terms:FOB,CIF,EXW

Payment Terms: T/T,Western Union,MoneyGram,L/C

Minimum Order: Negotiatable

Delivery Port: Customized

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Medical H.pylori antigen rapid test
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Product Packagings & Delivery Terms:

Packaging Detail: neutral pouch bulk package

Delivery Detail: 7-14 days

Specifications and Product Details:

Medical H.pylori antigen rapid test

INTENDED USE

The H. pylori Rapid Test Device (Feces) is a rapid chromatographic immunoassay for the qualitative detection of antigens to H. pylori in feces to aid in the diagnosis of H. pylori infection.

INTRODUCTION

H.Pylori Stool Card is a screening immunochromatographic assay to detect Helicobacter pylori antigen in stool samples.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.

The presence of the gene itself determines the persistence of the infection, the ulceration and the protein associated, VacA toxin is frequently the main cause of infiltrations in the gastric mucosa. This antigen associated to others, such as CagII, CagC, seems to act as starting agent of a sudden inflammatory response which can provoke ulceration (peptic ulcer), allergic episodes, and a decrease of the therapy efficacy. 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.

PRINCIPLE

H.Pylori Stool Card is a non-invasive lateral flow assay, rapid, precise and easy to perform.This test makes use of specific antibodies against H. pylori antigen adsorbed onto a reactive membrane. If H. pylori is present in stool specimen, the specific antigen is bound by the second antibody which is conjugated with colloidal gold particles. A generic antibody, fixed onto the reactive membrane, in shape of the band, is able to capture the second conjugated antibody, assuring the correctness of the test

ASSAY PROCEDURE

Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.

1. Specimen collection and pre-treatment:

1) Unscrew and remove the dilution tube applicator. 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.

2) Place the applicator back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.

3) Shake the specimen collection tube vigorously to mix the specimen and the extraction buffer. Specimens prepared in the specimen collection tube may be stored for 6 months at -20°C if not tested within 1 hour after preparation.

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 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 at 5 minutes. Do not interpret the result after 10 minutes.

INTERPRETATION OF RESULTS

1. Positive: In addition to the control band (C), a distinct colored band also appears in the test region (T).

2. Negative: Only one colored band appears on the control region (C). No colored band in the test region (T).

3. Invalid: If no bands appear, or a test band appears without a control band, the test should be repeated using a new test device.

GEMINOL

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