H. pylori IgM ELISA Kit

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Enzyme Immunoassay for the Qualitative Determination of H. pylori IgM in Human Serum

Introduction

Helicobacter pylori (H. pylori) is a gram-negative bacterium commonly found in gastric mucosa. It is present in approximately 95–98% of patients with duodenal ulcers and 60–90% of patients with gastric ulcers (Peterson, 1991). Various diagnostic techniques, including bacteriological, histological, and serological tests, estimate an infection rate of 90% among symptomatic patients. Additionally, about 50% of adults over 50 years of age are colonized by the bacterium without clinical symptoms (McGuigan, 1988). Studies have demonstrated that eradication of H. pylori through antimicrobial therapy is associated with symptom resolution and disease cure (Podolsky, 1989).

Patients exhibiting gastrointestinal symptoms may be diagnosed using:

  1. Invasive techniques – biopsy followed by culture, histological examination, or urease activity detection.
  2. Non-invasive techniques – urea breath tests and serological methods.

Serological tests, such as enzyme-linked immunosorbent assays (ELISA), are valuable for detecting specific immune responses to H. pylori. The H. pylori IgM ELISA test is particularly useful for identifying early-stage infections by measuring IgM antibodies, making it a preferred diagnostic tool (Perez & Blaser, 1991).

Clinical Significance

H. pylori infections are associated with various gastrointestinal disorders, including chronic gastritis, peptic ulcers, and gastric malignancies. The presence of IgM antibodies against H. pylori is indicative of a recent or active infection, distinguishing it from IgG, which signifies past exposure (Perez & Blaser, 1991). Early diagnosis via IgM detection is critical in initiating timely treatment and preventing complications such as gastric cancer and mucosa-associated lymphoid tissue (MALT) lymphoma.

Test Principle

The H. pylori IgM ELISA kit is based on an indirect ELISA technique. Microtiter wells are pre-coated with H. pylori antigens. Diluted serum samples are added to the wells. If IgM antibodies are present, they bind to the antigen. Wells are washed to remove unbound components. Anti-human IgM horseradish peroxidase (HRP)-conjugated secondary antibody is added. After a second incubation and wash, chromogen-substrate solution is introduced, producing a blue color. The reaction is stopped using an acid solution, changing the color to yellow, which is then measured spectrophotometrically at 450 nm. The absorbance is directly proportional to the concentration of specific anti-H. pylori IgM.

References

  • McGuigan, J. E. (1988). Peptic ulcer and gastritis. Harrison’s Principles of Internal Medicine, 12th ed., 1229–1248.
  • Peterson, W. L. (1991). pylori and peptic ulcer disease. New England Journal of Medicine, 324, 1024–1047.
  • Podolsky, I. (1989). Prevalence of pylori in healthy subjects and patients with peptic disease. Gastroenterology, 96(suppl), A394.
  • Perez, C. I., & Blaser, M. O. (1991). Serodiagnosis of pylori: Comparison of enzyme-linked immunosorbent assays. Journal of Clinical Microbiology, 29, 1635–1639.