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H. pylori IgM ELISA Test


H. pylori IgM ELISA kit

Full name

Human Helicobacter pylori IgM ELISA Test kit

Category Name Infectious Disease ELISA kits
Test 96
Method ELISA: Enzyme Linked Immunosorbent Assay
Principle ELISA - Indirect; Antigen Coated Plate
Detection Range Qualitative Positive; Negative control & Cut off
Sample 5ul Serum
Specificity 98%
Sensitivity 98%
Total Time ~90 min
Shelf Life 12 Months from the manufacturing date

Item #:                    1504-11   Quantity:               

H. pylori IgM ELISA Test


H. pylori IgM ELISA Test

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H. pylori IgM ELISA Test description:

Diagnostic Automation offers H. pylori IgM 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 IgM antibody is the technique of choice for serologic tests because of its accuracy and simplicity.

Materials Provided with H. pylori IgM Elisa Kit:

1. Purified H. pylori antigen coated Microwell, 12 X 8 Strips
2. Sample Diluent, 22 ml
3. H. pylori IgM ELISA Test Calibrator, 150ul
4. H. pylori IgM EIA kit Negative Control, 150ul
5. H. pylori IgM EIA kit Positive Control, 150ul
6. Washing Concentrate 20X, 50ml
7. H. pylori IgM 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 IgM ELISA Kit Background Information
Helicobacter pylori is a spiral bacterium cultured from human gastric mucosa identified by Marshall in 1982. Studies have indicated that the presence of H. pylori 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 IgM ELISA Test Principle
Purified H. pylori antigen is coated on the surface of microwells. Diluted patient serum is added to wells and H. pylori IgM 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 IgM specific antibody in the sample. The results are read by a microwell reader compared in a parallel manner with calibrator and controls.

H. pylori IgM ELISA Test Results Interpretation
Negative: H. pylori M Index of 0.90 or less are seronegative for IgM 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.

Precaution with H. pylori IgM 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


H. pylori IgG ELISA Kit


H. Pylori Antigen ELISA kit


H. pylori Rapid Tests

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


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


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

Diagnostic Automation Inc. also provides other Test Kits:


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.

Product Note:

Our H. Pylori IgM ELISA kit has high specificity and sensitivity.

The most recent study shows that oropharynx constitutes an  extragastric reservoir of H. pylori infection. This  reservoir could serve as  an aetiopathogenetic factor for chronic  tonsillitis and tonsillar haperplasia.

Ref: Nártová E. et al.  Eur Arch Otorhinolaryngol. 2013 Jul 18