The Calbiotech Helicobacter pylori (H. pylori) IgM ELISA Kit is intended for the detection of IgM antibody to H. pylori in human serum or plasma.
SUMMARY AND EXPLANATION
H. pylori is detectable in nearly 100% of adult patients with duodenal ulcer and about 80% of patients with gastric ulcer.An association between H. pylori and gastric cancer is confirmed. In developing countries, where most children become infected by the age of 10, gastric cancer rates are very high. In the USA and other developed countries, standards of hygiene and the increasing socioeconomic status of the population have reduced the incidence of infection, and in parallel, the rates of peptic ulcers and gastric cancer have declined. There is excellent correlation between the clinical presentation of gastritis, the presence of H. pylori in the stomach and elevated serum H. pylori antibodies. ELISA sensitivity and specificity are 90%, and the predictive value of a negative result for is very high. H. pylori-specific antibodies falls significantly after successful antibacterial therapy. Eradication of H. pylori is associated with a significant reduction in duodenal ulcer recurrence. H. pylori strains are classified into two broad groups – those that express both VacA and CagA (type I) and those that produce neither (type II).Type I strains are predominate in patients with ulcers and cancer. Up to 50% of adults is infected with H. pylori, but most of them are asymptotic and will not develop ulcer. The reason is they are infected with type II. 80-100% of patients with duodenal ulcer disease produce CagA antibodies against a 128 kd antigen compared with 60-63% of H. pylori-infected persons with gastritis only, indicating that serologic responses to the 128 kd protein are more prevalent among H. pylori-infected persons with duodenal ulcers than infected persons without peptic ulceration.In H. pylori-infected patients who develop gastric cancer, antibodies against CagA are94% sensitive and 93% specific,indicating that detection of antibodies to CagA is useful marker for diagnosis of duodenal ulcer and gastric cancer.
PRINCIPLE OF THE TEST
Diluted patient serum (serum diluent contains sorbent to remove rheumatoid factor and human IgG interference) is added to wells coated with purified antigen. IgM specific antibody, if present, binds to the antigen. All unbound materials are washed away and the enzyme conjugate is added to bind to the antibody-antigen complex, if present. Excess enzyme conjugate is washed off and substrate is added. The plate is incubated to allow the hydrolysis of the substrate by the enzyme. The intensity of the color generated is proportional to the amount of IgM specific antibody in the sample.