Helicobacter pylori (H. pylori) is a spiral, gram-negative bacillus known to be the causative agent in chronic gastritis. The bacterium is one of the most common causes of duodenal and gastric ulcers as well as gastric carcinoma and gastric lymphoma. It currently infects an estimated two-thirds of the world’s population with 500,000-850,000 new cases of H. pylori annually diagnosed.
Despite thorough investigation the reservoirs of H. pylori remain undetermined. Contaminated water sources are a likely reservoir of the bacterium with poor water supply, hygiene and sanitation and crowded living conditions thought to contribute to incidence. Subsequently the transmission mode of H. pylori is also unknown but oral to oral or faecal to oral routes are most likely.
Helicobacter pylori diagnosis is comprised of both invasive and non-invasive methods. Gastroscopy and histological diagnosis have produced highly accurate results along with the urea breath test with all methods considered gold standards. The urea breath test can be used for non-invasive detection of active infection or to determine if successful eradication of the pathogen has occurred. Diagnosis through serological methods can determine if an immune response to H. pylori has occurred by detecting antibodies to the bacterium.
The evaluation performed aims to determine the performance of the DiaSorin Helicobacter pylori IgG on the DiaSorin Liaison XL in comparison to in comparison to the currently used SD BIOLINE H. pylori Rapid Test, and determine whether the DiaSorin Helicobacter pylori IgG is suitable candidate for use in the detection of IgG class antibodies as a possible sero-diagnostic technique to be used at Pathology North, Royal North Shore Hospital.