Diagnostic Automation offers H. pylori IgG ELISA kit for evaluating the serologic status to H. pylori infection in patients with gastrointestinal symptoms. H. pylori elisa testing the presence of H. pylori specific IgG antibody, is the technique of choice for serologic tests because of its accuracy and simplicity.


Materials Provided with H. pylori IgG Elisa Kit:

1. Purified H. pylori antigen coated Microwell, 12 X 8 Strips
2. Sample Diluent, 22 ml
3. H. pylori IgG ELISA Test Calibrator, 150ul
4. H. pylori IgG EIA kit Negative Control, 150ul
5. H. pylori IgG EIA kit Positive Control, 150ul
6. Washing Concentrate 20X, 50ml
7. H. pylori IgG ELISA Test Enzyme Conjugate, 12ml
8. TMB Chromogenic Substrate, l2ml
9. Stop Solution, 12ml


Materials & Instrumentations required, not included:

1. Precision pipettes and tips
2. Distilled or deionized water
3. EIA kit Microplate Washer
4. EIA kit Microplate Reader 450nm



H. pylori ELISA Kit Background Information
Helicobacter pylori is a spiral bacterium cultured from human gastric mucosa identified by Marshall in 1982. Studies have indicated that H. pylori detection is associated with a variety of gastrointestinal diseases including gastritis, duodenal and gastric ulcer, non-ulcer dyspepsia, gastric adenocarcinoma and lymphoma. The organism is present in 95-98% of patients with duodenal ulcer and 60-90% of patients with gastric ulcers. Multiple studies have also demonstrated that removal of the organism by antimicrobial therapy is correlated with the resolution of symptoms and cure of diseases. Patients who present with clinical symptoms relating to the gastrointestinal tract can be diagnosed for H. pylori infection by two methods:
1. Invasive techniques include biopsy followed by culture or histologic examination of biopsy specimen or direct detection of urease activity
2. Non-invasive techniques include urea breath tests and serological methods. Serologic tests are employed to detect antibodies as human immune response to H. pylori. Two methods appear to be of great interest regarding their use in H. pylori routine serology, namely the ELISA and the Western immunoblot because they offer the most versatility in regards to immunoglobulin specificity and relative ease of use.


H. pylori ELISA Test Kit Principle
Purified H. pylori antigen is coated on the surface of microwells. Diluted patient serum is added to wells and H. pylori IgG specific antibody, if present, binds to the antigen. All unbound materials are washed away. After adding enzyme conjugate, it binds to the antibody-antigen complex. Excess enzyme conjugate is washed off and TMB Chromogenic substrate is added. The enzyme conjugate catalytic reaction is stopped at a specific time. The intensity of the color generated is proportional to the amount of IgG specific antibody in the sample. The results are read by a microwell reader compared in a parallel manner with calibrator and controls.


H. pylori ELISA Test Results Interpretation
Negative: H. pylori M Index of 0.90 or less are seronegative for IgG antibody to H. pylori.
Positive: H. pylori M Index of 1.00 or greater are seropositive. For additional details please refer to the instructions for use.


H. pylori ELISA Test Performance Characteristics
Total of 347 patient samples were used to evaluate specificity and sensitivity of this H. pylori elisa test.
The precision of the assay was evaluated by testing three different sera, eight replicates on 3 days. The intra-assay and inter-assay C.V. are summarized below:
Intra-assay: Negative 9.1% Low positive 8.5% Positive 6.4%
Inter-assay: Negative 10.5% Low positive 8.9% Positive 7.5%


Precaution with H. pylori ELISA Kit
The calibrator and controls contain human source components which have been tested and found
Non-reactive for hepatitis B surface antigen as well as HIV antibody with FDA licensed reagents. However, these reagents should be handled at the Biosafety Level 2.


H. pylori Related ELISA Kits:

H. pylori IgA ELISA kit

http://www.rapidtest.com/index.php?i=H.-pylori-IgA-ELISA-kit&id=141&cat=16


H. pylori IgM ELISA kit

http://www.rapidtest.com/index.php?i=H.-pylori-IgM-ELISA-kit&id=142&cat=16


H. Pylori Antigen ELISA kit

http://www.rapidtest.com/index.php?i=H.-Pylori-Antigen-ELISA-kit&id=613&cat=16


H. pylori Rapid Tests


H. Pylori Rapid Test Serum (Cassette) 118561-1

http://www.rapidtest.com/index.php?i=H.-Pylori-Rapid-Test--Serum---(Cassette)-&id=387&cat=26

H. Pylori Rapid Test (Cassette Serum / Whole Blood Test) 118562-1

http://www.rapidtest.com/index.php?i=H.-Pylori-Rapid-Test-(Cassette-Serum-/-Whole-Blood-Test)&id=668&cat=26

H. Pylori Antigen Rapid Test (Cassette)118564-1

http://www.rapidtest.com/index.php?i=H.-Pylori-Antigen-Rapid-Test-(Cassette)-&id=388&cat=26

Diagnostic Automation Inc. also provides other Test Kits:

http://www.rapidtest.com/index.php?product


For more information about ELISA Kits, Rapid Tests, IFA Kits, CLIA Test Kits, or Serology tests, please see our website home page, or contact our Customer Service Representative
at 818-591-3030.