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Helicobacter Pylori IgG ELISA Kit

INTENDED USE

Human helicobacter pylori IgG ELISA kit is designed for detecting in-vitro quantitative levels of human IgG antibodies against helicobacter pylori (helicobacter pylori-IgG) in serum and plasma. This assay has a minimum analytical sensitivity limit of 1.16 U/ml.

BACKGROUND

Helicobacter pylori (H. pylori) is a gram negative bacteria which is usually associated with stomach cancers (especially non-cardia gastric cancer). It has the ability to enter the body and attack the lining of the stomach, which is functioning to protect from the acid used to digest food. Prolonged infection can lead to the development of ulcers, excess bleeding and prevention of food moving through the digestive tract. H. pylori are helix-shaped bacteria which are also called curved rods, having a diameter of 0.5μm and length 3μm.

HELICOBACTER PYLORI IGG 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.
  • Sample Diluent.
  • Washing Buffer (10x).
  • Stop Solution.
  • Calibrator B (Cut-Off Standard).
  • Calibrator D (Positive Control).
  • Calibrator C (Weak Positive Control).
  • Calibrator A (Negative Control).

SENSITIVITY

The minimum detection sensitivity level of IgG antibodies to helicobacter pylori (helicobacter pylori IgG) using current human helicobacter pylori-IgG ELISA kit was 1.16 U/ml. The dynamic range for this assay is 1.0 – 150.0 U/ml.

ASSAY CHARACTERSTICS

– Helicobacter pylori ELISA: IgG
– Intra-Assay-Precision: 8.5 %
– Inter-Assay-Precision: 6.3 %
– Inter-Lot-Precision: 3.6 – 10.8 %
– Analytical Sensitivity: 1.16 U/mL
– Recovery: 90 – 93 %
– Linearity: 82 – 118 %
– 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: 96 %
– Clinical Sensitivity: 86 %

REFERENCES

  1. Preferential placental transfer of Helicobacter pylori specific IgG. J Matern Fetal Neonatal Med. (2004) 16 (5): 297-301. Doroudchi M., et al.
  2. Usefulness of serological IgG antibody determinations for confirming eradication of Helicobacter pylori infection. Am J Gastroenterol. (1999) 94 (8): 2105-8. Marchildon P., et al.
  3. Performance evaluation of a rapid whole-blood immunoassay for the detection of IgG antibodies against Helicobacter pylori in daily clinical practice. Ann Clin Microbiol Antimicrob. (2016) 15 (1): 47. Enko D., et al.
  4. IgG antibody titer against Helicobacter pylori correlates with presence of cytotoxin associated gene A-positive H. pylori strains. FEMS Immunol Med Microbiol. (2000) 28 (2): 139-41. Loffeld R.J., et al.
  5. Four-year trends in Helicobacter pylori IgG serology following successful eradication. Am J Med. (1998) 105 (1): 18-20. Cutler A.F., et al.

ADDITIONAL INFORMATION

  • Full Name: Helicobacter Pylori IgG ELISA Kit
  • Reactivity: Human
  • Sample Type: Serum, Plasma
  • Sensitivity: 1.16 U/ml

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