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H. Pylori Antigen ELISA Test

Name

H. Pylori Antigen ELISA test kit

Full name

Human Helicobacter pylori Antigen Stool ELISA Test Kit

Category Name Infectious Disease ELISA kits
Test 96
Method ELISA: Enzyme Linked Immunosorbent Assay
Principle ELISA: Sandwich Antibody Coated Plate
Detection Range Quantitative: 0-100 ng/ml
Sample 100 ul of Treated Stool Sample
Specificity Not Determined
Sensitivity 0.5 ng/ml
Total Time ~ 75 min
Shelf Life 12 Months from the manufacturing date

Item #:                    1506-11   Quantity:               

H. Pylori Antigen ELISA Test


H. Pylori Antigen ELISA Test

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H. Pylori Antigen ELISA Test description:




Diagnostic Automation Helicobacter pylori Antigen ELISA Test is a quantitative assay for the detection of H. pylori antigens in human stool specimens. 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.

Materials Provided with H. pylori Antigen ELISA Kit:

1. Purified monoclonal H. pylori antibody coated Microwell, 12 X 8 Strips
2. Sample Treatment Solution, 100 ml
3. H. pylori Antigen ELISA Test Calibrator Set: 0, 6.3, 12.5, 25, 50, 100ng/ml, 1 ml/ vial
4. H. pylori Antigen EIA Negative Control, 1ml
5. H. pylori Antigen EIA Positive Control, 1ml
6. Washing Concentrate 20X, 50ml
7. H. pylori Antigen ELISA Test Enzyme Conjugate, 12ml
8. TMB Chromogenic Substrate, l2ml
9. Stop Solution, 12ml


Materials & Instrumentations required, not included with H. pylori ELISA Kit:

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 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 Antigen Elisa Test Kit Principle
Purified H. pylori antibody is coated on the surface of microwells. An aliquot of diluted stool sample is added to wells, and the H. pylori antigens, if present, bind to the antibody. 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 antigen in the sample. The results are read by a microwell reader compared in a parallel manner with calibrator and controls.


H. Pylori Antigen Elisa Test Results Interpretation
Minimum detectable concentration: 0.5ng/ml
Negative: < 15 ng/ml
Positive: > 20 ng/ml


H. pylori elisa test Performance & Characteristics:
H. pylori elisa kit Cross Reactivity
A study was performed to determine the cross-reactivity with the following bacterial and viral strains: Camplylobactor coli, Camplylobactor fetus, Camplylobactor jejuni, Camplylobactor lari, Candida albicans, Enterobacter cloacae, Helicobacter cinaedi
All above positive samples were tested negative for Helicobacter pylori Antigen test.
H. pylori elisa kit Precision
The precision of the assay was evaluated by testing three different sera and eight replicate readings in 3 days. The intra-assay and inter-assay %CV are summarized below:
Low Positive Middle positive High Positive
Intra-assay 6.7% 4.7% 3.3%
Inter-assay 7.4% 2.7% 16.7%



H. pylori Antigen elisa Related test Kits:

H. pylori IgA ELISA kit

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

H. pylori IgG ELISA kit

http://www.rapidtest.com/index.php?i=H.-pylori-ELISA-Test&id=140&cat=16

H. pylori IgM ELISA kit

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

H. pylori Rapid Tests

H. Pylori Rapid Test (Cassette Serum) 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.



Product Note:


At least half the world's populations are infected by H. pylori, making it the most widespread infection in the world.  Actual infection rates vary from nation to nation.  The developing world has much higher infection rates than the West, including Australasia, North America, and Europe where rates are estimated to be around 25%.
Pounder RE, & Ng D (1995).  Aliment. Pharmacol. Ther. 9 (Suppl 2): 339. PMID 8547526

The age at which H. pylori is acquired seems to influence the possible pathologic outcome of the infection.   People infected with it at an early age are likely to develop more intense inflammation leading to atrophic gastritis with a higher subsequent risk of gastric ulcer, gastric cancer or both. Acquisition at an older age brings different gastric changes more likely to lead to duodenal ulcer.
Brown LM (2000). Epidemiol Rev 22 (2): 28397. PMID 11218379

Up to 85% of people infected with H. pylori never experience symptoms or complications
Bytzer P. etal., ( 2011). Dan Med Bull 58 (4): C4271. PMID 21466771

Our H. Pylori Antigen ELISA KIT with high sensitivity and specificity is a great tool for detecting H. pylori infection.




H. Pylori Antigen ELISA KIT INTENDED USE

Diagnostic Automation Helicobacter pylori Antigen ELISA is a quantitative assay for the detection of H. 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.

SUMMARY AND EXPLANATION OF THE TEST

Helicobacter pylori is a spiral bacterium cultured from human gastric mucosa by Marshall in 19821. 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. The studies have also demonstrated that removal of the organism by antimicrobial therapy is correlated with the resolution of symptoms and cure of diseases2. 

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 histological examination of biopsy specimen or direct detection of urease activity. The cost and discomfort to the patients are very high and biopsy samples are subject to errors related to sampling and interference of contaminated bacteria. 
2) Non-invasive techniques include urea breath tests (UBT)3 and serological methods4. The UBT requires a high density and active bacteria and should not be performed until 4 weeks after therapy to allow resisdual bacteria to increase to the detection level. The main limitation of serology test is the inability to distinguish current and past infections. 

Our H. Pylori Antigen ELISA KIT have high sensitivity and specificity.