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Helicobacter Pylori IgM ELISA Kit

INTENDED USE

Human Helicobacter pylori IgM ELISA kit is a procedure designed for measuring in-vitro quantitative amounts of human IgM antibodies to helicobacter pylori (helicobacter pylori-IgM) using serum or plasma samples. This assay has a minimum analytical sensitivity limit of 1.0 U/ml.

BACKGROUND

Helicobacter pylori is a bacterium which can cause infections of the stomach and the duodenum (upper part of small intestine), it can result in peptic ulcers. Some of the most common tests that are used to detect H. pylori include: blood antibody test, stool antigen test and stomach biopsy. If a positive test is obtained then treatment needs to be carried out in order to clear the infection, this in many cases will lead to healing the ulcer and also prevent it from returning. Helicobacter is a spiral shaped organism which also possess a flagella. It contains a potent multi-subunit urease enzyme, allowing it to survive the acidic pH conditions and colonize in the gastric environment. The human body’s natural defence system is unable to combat H. pylori since white and killer T cells are unable to penetrate through the stomach lining, these eventually die and spill their superoxide radicals on the cells lining the stomach, the H. pylori are able to feed on these.

HELICOBACTER PYLORI IGM ELISA KIT CONTENT

All reagents supplied need to be stored at 2 °C – 8 °C, unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.

  • Helicobacter pylori antigen coated microtiter strips.
  • Enzyme Conjugate.
  • TMB Substrate.
  • Calibrator A (Negative Control).
  • Calibrator D (Positive Control).
  • Calibrator B (Cut-Off Standard).
  • Calibrator C (Weak Positive Control).
  • Sample Diluent.
  • Washing Buffer (10x).
  • Stop Solution.

SENSITIVITY

The minimum detection sensitivity level of IgM antibodies directed against helicobacter pylori (helicobacter pylori IgM) using current human helicobacter pylori-IgM ELISA kit was 1.0 U/ml. The dynamic range for this assay is 1.0 – 150.0 U/ml.

ASSAY CHARACTERSTICS

– Helicobacter pylori ELISA: IgM
– Intra-Assay-Precision: 8.1 %
– Inter-Assay-Precision: 11.3 %
– Inter-Lot-Precision: 4.4 – 12.7 %
– Analytical Sensitivity: 1.03 U/mL
– Recovery: 88 – 107 %
– Linearity: 84 – 122 %
– Cross-Reactivity: No cross-reactivity to Yersinia enterocolitis.
– Interferences: No interferences to bilirubin up to 0.3 mg/mL, hemoglobin up to 8.0 mg/mL and triglycerides up to 5.0 mg/mL.
– Clinical Specificity: 99 %
– Clinical Sensitivity: 85 %

REFERENCES

  1. Usefulness of specific IgM in the diagnosis of Helicobacter pylori infection. Pediatrics. (1994) 93 (2): 342-3. Blecker U. and Vandenplas Y.
  2. Diagnostic value of detection of IgM antibodies to Helicobacter pylori. Exp Mol Pathol. (2002) 72 (1): 77-83. Alem M., et al.
  3. Downward shift in serum IgM with Helicobacter pylori seropositivity. J Infect. (2000) 41 (3): 240-4. Dobbs R.J., et al.
  4. Helicobacter pylori-specific IgM antibodies in children born to infected mothers. J Pediatr Gastroenterol Nutr. (1996) 22 (3): 337-8. Blecker U. and Vandenplas Y.

ADDITIONAL INFORMATION

  • Full Name: Helicobacter Pylori IgM ELISA Kit
  • Reactivity: Human
  • Sample Type: Serum, Plasma
  • Sensitivity: 1.0 U/ml

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