Gastritis and peptic ulcer are major illnesses that affect a significant number of individuals each year. Since the discovery of H. pylori in 1983, many reports have suggested a relationship between the presence of H. pylori and gastrointestinal disorders. Evidence of such correlation between the presence of H. pylori on gastric mucosa of patients with histological confirmed gastric, and peptic ulcer disease stimulated the development of serological techniques for the detection of antibodies to H. pylori. Many reports have shown that such serological techniques are simple and convenient for the detection of H. pylori in infected individuals. Detection of IgG antibodies against H. pylori in patient serum has been shown to be an aid for the detection of H. pylori infection in symptomatic patients.

There are significant differences in the choice of antigens for antibody detection and a wide variety of antigens have been used in assays measuring antibodies to H. pylori. For detection of H. pylori infection by serological methods, in addition to major antigenic components such as urease, the presence of proteins associated with CagA and VacA genes in the antigenic mixture are essential. Antibodies to CagA and VacA proteins are found in patients with peptic ulcer. Recent studies suggest that the presence of antibodies against CagA and VacA proteins may serve as markers for those strains of H. pylori associated with the greatest clinical impact. Several independent laboratories have compared the performance of the MDI H. pylori Kit to those of other commercially available kits. These laboratories have reported a better performance rate for the MDI H. pylori Kit.

Studies conducted by several independent laboratories compared the results obtained using well known commercially available kits with the results using MDI kits. The results of these studies showed better performance while MDI kits were used.