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Helicobacter Pylori IgA ELISA Kit

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

BACKGROUND

Helicobacter pylori which is most often shortened to H. pylori is a gram negative microaerophilic bacterium that can be found living in the sticky mucus that lines the stomach. They are spiral/helix-shaped bacteria that are often classified as curved rod, about 0.5μm in diameter and 3μm in length. H. pylori bacteria are unique by the fact they produce the enzyme urease themselves which allows it to live in the harsh environment of the stomach.

The infections caused by H. pylori are mostly harmless, however, they can be responsible for a large number of ulcers that are found in the stomach or the small intestines. H. pylori is considered contagious and can be passed from person to person by saliva, fecal contamination and through poor hygiene practices.

INTENDED USE

Human helicobacter pylori IgA ELISA kit is a procedure for in-vitro analysis of human IgA antibodies to helicobacter pylori (helicobacter pylori-IgA) using plasma or serum. This assay has a minimum analytical sensitivity limit of 1.0 U/ml.

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

SENSITIVITY

The minimum detection sensitivity level of human IgA antibodies against helicobacter pylori (helicobacter pylori-IgA) using current helicobacter pylori IgA ELISA kit was 1.0 U/ml. The dynamic range for this assay is 1.0 – 200.0 U/ml.

ASSAY CHARACTERSTICS

– Intra-Assay-Precision: 8.1 %
– Inter-Assay-Precision: 9.4 %
– Inter-Lot-Precision: 3.3 – 10.5 %
– Analytical Sensitivity: 1.04 U/mL
– Recovery: 113 – 126 %
– Linearity: 77 – 125 %
– 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: 95 %
– Clinical Sensitivity: 83 %

REFERENCES

  1. Helicobacter pylori participates in the pathogenesis of IgA nephropathy. Ren Fail. (2016) 38 (9): 1398-1404. Zhu T.T., et al.
  2. Decreased Helicobacter pylori-specific gastric secretory IgA antibodies in infected patients. Digestion. (1998) 59 (6): 638-45. Birkholz S., et al.
  3. Relationship between mucosal levels of Helicobacter pylori-specific IgA, interleukin-8 and gastric inflammation. Clin Sci (Lond). (1999) 96 (4): 409-14. Zhang Q.B., et al.
  4. Investigation of human colostrum Helicobacter pylori IgA content in lactating women. Eur J Obstet Gynecol Reprod Biol. (2006) 124 (1): 58-60. Tanriverdi H.A., et al.
  5. Helicobacter pylori_infections in IgA deficiency: lack of role for the secretory immune system. Clin Exp Immunol. (1996) 105 (2): 202-4. Bogstedt A.K., et al.

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