H.Pylori Ag ELISA Test Kit

INTENDED USE

An enzyme immunoassay (EIA) for the qualitative and quantitative detection of Helicobacter pylori (H. pylori) Antigen in human stool. For professional in vitro diagnostic use only.

The H. pylori Antigen EIA Test Kit is an enzyme immunoassay for the qualitative and quantitative detection of H. pylori antigen in human stool. It is intended as an aid in the diagnosis of possible H. pylori infection and in the follow-up of patients undergoing antimicrobial therapy.

SUMMARY AND CLINICAL SIGNIFICANCE

H. pylori is a small, spiral-shaped bacterium that lives in the surface of the stomach and duodenum. It is associated in the etiology of a variety of gastrointestinal diseases including duodenal and gastric ulcer, non-ulcer dyspepsia and active and chronic gastritis.1,2 H. pylori infection is present in over 90% of duodenal ulcers, 80% of gastric ulcers, and 70% of gastritis. The transmission route for H. pylori is currently unknown but believed to be transmitted by oral-oral or fecal-oral route. Methods of diagnosing H. pylori infection have been developed along two lines including the direct detection of the organism and the detection of antibodies to H. pylori. The direct, invasive and costly methods include urease testing (presumptive), culture, and/or histologic staining of biopsy material. Another direct method is the urea breath test, though non-invasive and highly sensitive and specific, requires expensive laboratory equipment and moderate radiation exposure. The most common non-invasive method is the serological detection of antibodies specific to H. pylori. Individuals infected with H. pylori develop serum antibodies which correlate strongly with histologically confirmed H. pylori infection.3,4,5 Early in the course of active infection, IgM antibody levels are detectable followed by a rise of IgG and IgA antibodies which remain constantly high until infection is eliminated. More recently, the use of enzyme immunoassay to detect the H. pylori antigens, which illicit the immune response, has been used for diagnosis of active H. pylori infection, patient monitoring after eradication therapy or reinfection. The H. pylori Antigen EIA Test Kit is an immunoassay for the qualitative and quantitative detection of the presence of H. pylori Antigen in human stool. The test utilizes antibodies to H. pylori to selectively detect H. pylori Antigen in human stool.

Product list

PRINCIPLE

The H. pylori Antigen EIA Test Kit is a solid phase enzyme immunoassay based on sandwich principle for the qualitative and quantitative detection of H. pylori antigen in human stool. The microwell plate is coated with anti-H. pylori antibodies. During testing, the antigens are extracted out with extraction solution and added to the antibodies coated microwell plate with the enzyme-conjugated antibodies to H. pylori and then incubated. If the specimens contain H. pylori antigens, it will bind to the antibodies coated on the microwell plate and simultaneously bind to the conjugate to form immobilized antibody-H. pylori antigen-conjugate complexes. If the specimens do not contain H. pylori antigens, the complexes will not be formed. After initial incubation, the microwell plate is washed to remove unbound materials. Substrate A and substrate B are added and then incubated to produce a blue color indicating the amount of H. pylori antigens present in the specimens. Sulfuric acid solution is added to the microwell plate to stop the reaction producing a color change from blue to yellow. The color intensity, which corresponds to the amount of H. pylori antigens present in the specimens, is measured with a microplate reader at 450/630-700 nm or 450 nm.

PRECAUTIONS

• For professional in vitro diagnostic use only. Do not use after expiration date.

• Do not mix reagents from other kits with different lot numbers.

• Avoid cross contamination between reagents to ensure valid test results.

• Follow the wash procedure to ensure optimum assay performance.

• Use Plate Sealer to cover microwell plate during incubation to minimize evaporation.

• Use a new pipet tip for each specimen assayed.

• Ensure that the bottom of the plate is clean and dry and that no bubbles are present on the surface of the liquid before reading the plate. Do not allow wells to dry out during the assay procedure.

• Do not touch the bottom of the wells with pipette tips. Do not touch the bottom of the microwell plate with fingertips.

• Do not allow sodium hypochlorite fumes from chlorine bleach or other sources to contact the microwell plate during the assay as the color reaction may be inhibited.

• All equipment should be used with care, calibrated regularly and maintained following the equipment manufacturer’s instructions.

STORAGE AND STABILITY

•Unopened test kits should be stored at 2-8°C upon receipt. All unopened reagents are stable through the expiration date printed on the box if stored between 2-8°C. Once opened, all reagents are stable for up to 3 months after the first opening date if stored between 2-8°C. Return reagents to 2-8°C immediately after use.

• Allow the sealed pouch to reach room temperature before opening the pouch and remove the required number of strips to prevent condensation of the microwell plate. The remaining unused strips should be stored in the original resealable pouch with desiccant supplied at 2-8C and can be used within 3 months of the opening date. Return the remaining unused strips and supplied desiccant to the original resealable pouch, firmly press the seal closure to seal the pouch completely and immediately store at 2-8C.

• Concentrated Wash Buffer may be stored at room temperature to avoid crystallization. If crystals are present, warm up the solution at 37°C. Working Wash Buffer is stable for 2 weeks at room temperature.

• Do not expose reagents especially the Substrate to strong light or hypochlorite fumes during storage or incubation steps. • Do not store Stop Solution in a shallow dish or return it to the original bottle after use.

PREPARATIONS

1. Allow all specimens and reagents to reach room temperature (~25°C) and mix thoroughly by gentle inversion before use.

2.Prepare Wash Buffer by diluting Wash Concentrate 20-fold with deionized water. The diluted wash solution is stable in room temperature for at least one week.

PRECAUTION FOR USERS

1. Handling should preclude any pipetting by mouth. Use only pipettes with disposable tips for each specimen.

2.Do not mix materials from different master lots. Do not use kit components beyond the expiration date.

3.All materials should be brought to room temperature before use.

Biovantion Inc is independent from international department of Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro diagnostic reagents manufacturer engaged in the research, development, production, and focus on clinical testing for infectious diseases, such as Hepatitis virus, Noro virus, Parvo virus test kits, our products include rapid test cassette and Elisa kits.

All our products have been registered in National Medical Products Administration of China, in year 2020 we get Certificate of ISO 13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from SGS. More importantly, we have awarded the registration certificate from National Medical Products Administration for Diagnostic Kit for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during the outbreak in China, and also we developed COVID-19 Antigen test ; Neutralizing Antibody Test, these products selling well all overthe world