Helicobacter pylori IgG/A Serological Testing

Improve sensitivity and specificity for the most virulent strains with GSD's H. pylori EIA kit.

Gold Standard Diagnostics H. pylori IgG and IgA ELISA tests offer excellent sensitivity and specificity, especially for the more virulent CagA and VacA strains of H. pylori.

Research has demonstrated a link between strains that express CagA and VacA antigen, and increased risk of gastric cancer1 and ulcer2. H. pylori serological testing detects the most virulent strains that express CagA and VacA antigens.

Gold Standard Diagnostics H. pylori EIA's are manufactured using a proprietary antigen and purification process developed by an H. pylori specialist from the Institute for Medical Microbiology and Hygiene in Germany.

Please contact us for ordering information.

 

GSD H. pylori Serological Testing Advantages

Non-invasive, automated and cost-effective... Best option for pre-treatment diagnosis.

Key Benefits:

  • FDA Cleared
  • Excellent sensitivity & specificity.
  • Detects CagA & VacA positive strains.
  • Best option for pre-treatment testing.
  • Non-invasive and low cost compared to other diagnostic methods.

Important H. pylori Antigens

Proteins:

  • CagA - virulent H. pylori strains
  • VacA - virulent H. pylori strains
  • UreA - general H. pylori marker

Alternative Diagnostic Methods

Serological testing is a non-invasive, reliable and cost-effective method of diagnosing an H. pylori infection. Alternative methods include: Biopsy, Urea Testing and Stool Testing.

Method Sample Detection
Culture Biopsy Living Bacteria
Histology Biopsy Bacteria
Urea Rapid Test Biopsy Ammonia Ions
Urea Breath Test Breathe 13C-labelled CO2
Antigen ELISA Stool H. pylori antigen
Antibody ELISA Serum H. pylori antibody
Antibody Western Blot Serum H. pylori antibody

Culture and Histology directly detect the presence of H. pylori bacteria.

  • Biopsy of gastric mucosa required.
  • Extremely invasive and expensive.

13/14C-Urea Breath Test detects 13/14C-labelled urea produced by H. pylori.

  • Requires expensive equipment.
  • Patient must fast.
  • Performed in a doctor’s office with specially trained personnel.
  • False negatives: after antibiotic therapy.
  • False positives: Achlorydria, and other urease-producing bacteria.

Antigen Stool ELISAs detect H. pylori antigens in stool specimen.

  • Good to confirm eradication.
  • Moderately invasive.
  • Cost-effective.

H. pylori Facts & Treatment

H. pylori Quick Facts:

  • Cork-screw shaped, gram negative bacterium
  • Lives in the stomach of 3 billion people worldwide
  • Linked to Peptic Ulcer Disease, MALT Lymphoma and Gastric Cancer.
  • World Health Organization – Class 1 Carcinogen

H. pylori Treatment

  • Antibiotic treatment is effective (up to 90%)
  • Lifelong immunity likely after successful treatment

Treatment benefits:

  • Infection cured
  • Symptoms often disappear
  • Low risk of relapse

Diagnosis & Treatment Process

Once a physician suspects an H. pylori infection may be causing gastrointestinal issues for the patient, a number of different tests can be used to detect H. pylori. Certain medications and complicating factors may limit which types of tests are able to be used. Serological testing, however, is not affected by any recent medications or other bacteria that metabolize urease. Except for children or patients with severe, recurring or persistent symptoms is being tested, serological testing provides a straightforward method of diagnosis.

H. pylori Diagnostics Studies

  1. Clinical relevance of the cagA, vacA, and iceA status of Helicobacter pylori. Leen-Jan van Doorn, Ceu Figueiredo, Ricardo Sanna, Anton Plaisier, Peter Schneeberger, Wink de Boer, Wim Quint. Received 10 December 1997; accepted 13 March 1998.Gastroenterology Volume 115, Issue 1 , Pages 58-66, July 1998.
  2. Risk for gastric cancer in people with CagA positive or CagA negative Helicobacter pylori infection. J Parsonnet, G D Friedman, N Orentreich, H Vogelman Gut 1997;40:297-301 doi:10.1136/gut.40.3.297
  3. Helicobacter pylori infection and the development of gastric cancer. Uemura N, Okamoto S, Yamamoto S, Matsumura N, Yamaguchi ,Yamakido M, Taniyama K, Sasaki N, Schlemper RJ. N Engl J Med. 2001 Sep 13;345(11):784-9.
  4. CagA+ Helicobacter pylori infection and gastric cancer risk in the EPIC-EURGAST study. CA Gonzalez et al., Int J Cancer, February 15, 2007; 120(4):859-67
  5. Combined serum IgG response to Helicobacter pylori VacA and CagA predicts gastric Cancer. LP Andersen et al., FEMS Immunol Med Microbiol, July 1, 2007;50(2):220-5