A novel immunoassay based on monoclonal antibodies for the detection of Helicobacter pylori antigens in human stool.

BACKGROUND AND AIM: With the Premier Platinum HpSA EIAtrade mark a new enzyme immunoassay was developed for diagnosis of H. pylori infection, using polyclonal antibodies against H. pylori antigens in human stool. Here we evaluated FemtoLab H. pyloritrade mark based on the use of monoclonal antibodies in comparison to established reference methods.
METHODS: 53 consecutive patients (27male, 26 female, age: 17-85 years) undergoing routine upper gastrointestinal endoscopy were enrolled in this study. The H. pylori status was determined by 4 reference methods: Histology, rapid urease test (HUT), (13)C-urea breath test ((13)C-UBT) and serology. Patients were considered to be infected with H. pylori if at least 2 of the 4 reference tests were positive. Stool samples were aliquoted after reception and stored frozen (-20 degrees C) until tested. The FemtoLab H. pyloritrade mark (Connex GmbH, Germany) and the Premier Platinum HpSA EIAtrade mark (Meridian, Connecticut, Ohio, USA) were performed according to the manufacturers protocols.
RESULTS: 26 of the 53 patients were H. pylori infected. 3 were false-negative by the FemtoLab H. pyloritrade mark and one false-positive result was obtained (sensitivity 88,5 %, specificity 96,3 %). The concordance between the 2 stool tests was 94,3 % (50/53 cases).
CONCLUSION: The diagnostic quality of the novel FemtoLab H. pyloritrade mark Enzyme Immunoassay is comparable with the established Premier Platinum HpSA EIAtrade mark. The differences between positive and negative results obtained with the FemtoLab H. pyloritrade mark are greater in comparison to the Premier Platinum HpSA EIAtrade mark and therefore this test system allows a better distinction.