Быстрый иммунотест для кассеты H-pylory

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Трекер стоимости

Характеристики

  rapid immunoassay test for H-pylory Ag Cassette

INTENDED USE

The H.pylori Stool Antigen Test is an in vitro qualitative immunochromatographic assay for the rapid detection of Helicobacter pylori antigens in human stool specimen. The test results are intended to aid in the diagnosis of H. pylori infection, to monitor the effectiveness of therapeutic treatment and to confirm the eradication of H. pylori in peptic ulcer patients.

Helicobacter pylori is a corkscrew-shaped, gram-negative rod that lives in the mucous layer of the stomach. H. pylori infection is now accepted as the most common cause of gastritis, and is etiologically involved in gastric ulcer, duodenal ulcer, gastric adenocarcinoma and primary gastric B-cell lymphoma.1,2 The organism is very common, infected at least half of the world’s population. H. pylori infection is typically acquired in childhood. Once acquired, infection persists chronically, probably continuing in the. stomach throughout life. The damage to gastric structure and function of stomach is constant and direct. Approximately one in six of H. pylori infection develops peptic ulcer disease and a small portion of H. pylori infection leads to gastric cancer.3 The diagnostic tests for H. pylori can be classified into two categories: Invasive and Noninvasive tests. Direct detection by invasive test procedures requires an endoscopy and biopsy specimens from antrum and stomach body.4 The presence of H. pylori is then confirmed by direct culture, histological examination or rapid urease test. The endoscopy and biopsy specimens offer direct detection of active H. pylori infections. Although the procedure is highly specific and high positive predictive value, the cost and discomfort to the patients are very high. The most widely available noninvasive test is probably the serological based test. The serology test detects H. pylori specific IgG antibody in patient serum with current or prior infection.5,6 Serology test is a simple, convenient test with relative high sensitivity. The main limitation of serology test is the inability to distinguish current and past infections. Antibody may be present in the patient’s serum long after eradication of the organism.6 The urease breath test (UBT) with 14C or 13C labeled urea, is a noninvasive test based on the urease activity of the organism. UBT detects active H. pylori infection and is highly sensitive and specific. The UBT requires a high density and active bacteria and should not be performed until 4 weeks after therapy to allow residual bacterial to increase to a sufficient number for detection.7

H. pylori Antigen Test is an mmunochromatographic assay that uses antibody- coated colloidal gold to detect the presence of H. pylori antigens in stool specimens. The test detects directly antigens in specimens for an active infection. The test is simple and easy to perform and the test results can be visually interpreted within 15 minutes

PRINCIPLE OF THE ASSAY

H. pylori Stool Antigen Test is a sandwich solid phase immunochromatographic assay. To perform the test, an aliquot of diluted stool sample is added to the sample well of the test cassette. The sample flows through a label pad containing H. pylori antibody coupled to red-colored colloidal gold. If the sample contains H. pylori antigens, the antigen will bind to the antibody coated on the colloidal gold particles to form antigen-antibody-gold complexes. These complexes move on the nitrocellulose membrane by capillary action toward the test line region on which H. pylori specific antibodies are immobilized. As the complexes reach the test line, they will bind to the antibody on the membrane in the form of a line. A second red control line will always appear in the result window to indicate that the test has been correctly performed and the test device functions properly. If H. pylori antigen is not present or lower than the detection limit of the test, only the control line will be visible. If the control line dose not developed, the test is invalid.

SPECIMEN COLLECTION

Stool specimens should be collected in containers that do not contain media, preservatives, animal serum or detergents as any of these additives may interfere with the HP Stool Ag Test. Specimens may be stored at 2-8°C for 3 days without interfering with the assay performance. For long-term storage of specimens, -20°C or colder is recommended. Repeated freezing and thawing of specimens is not recommended and may cause erroneous results. Do not store specimens in self-defrosting freezers.

The HP Stool Ag Test can be stored at any temperaturebetween 4-30°C.Do not freeze. The stability of the kit under these storageconditions is 24 months. Use up the reagents as soon as possible after the kit is unpacked within 3 months.

RESULT

INTERPRETATION OF RESULTS

Negative:  One pink line appears in control line, showing the test has been carried out correctly.There will be no line in test region

Positive:  In addition to a pink colored control line, a distinct pink colored band will also appear in the test region.

Invalid:  A total absence of color in both regions is an indication of procedure error and/or that the test reagent has deteriorated. The test should be repeated using a new strip.

Assay Specificity

Following bacterial and viral strains were used to test the specificity of HP Stool Ag Test. Positive and negative stools were spiked with >1x108 organism/ml and tested by HP Stool Ag Test. H. pylori positive stool remained positive with the spiked organisms. Negative stool remained negative with the spiked organisms.

Our Services

1:Factory direct price .price is competitive with high quality

2: Original manufacturer provide OEM service for you.

3: Smooth delivery near beijing and tianjin Port.

4: Free samples available sent for your evalutaiton

5: GMP, ISO9001:2008, SFDA and ISO13485 certificates

 

Company Information

Our company is in Beijing, China beginning built in 1988.Specialized in the field of ELISA TESTS&RAPID TESTS as both supplier and manufacturer with GMP,ISO9001:2008, SFDA and ISO13485 certificates. Our company was the earliest domestic high-tech enterprise which specializes in the research, test, manufacture and sale of genetic engineering drugs and diagnostic reagent.

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