Helicobacter Pylori IgG ELISA Kit

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


Helicobacter pylori (H. pylori) is a gram negative bacteria which is usually associated with stomach cancers (especially non-cardia gastric cancer). It can enter the body and attack the lining of the stomach, the acid used in the stomach to digest food functions to protect the lining from the bacteria.

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.


Human helicobacter pylori IgG ELISA kit is designed for detecting in-vitro 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.


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).


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


– 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 %


  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.


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