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 EIA (TM) a new enzyme im munoassay was developed for diagnosis of H. pylori infection, using polyclo nal antibodies against H. pylori antigens in human stool. Here we evaluated FemtoLab H. pylori (TM) based on the use of monoclonal antibodies in compa rison to established reference methods. Methods: 53 consecutive patients (27 male, 26 female, age: 17-85 years) und ergoing routine upper gastrointestinal endoscopy were enrolled in this stud y. The H. pylori status was determined by 4 reference methods: Histology, r apid urease test (HUT), C-13-urea breath test (C-13-UBT) and serology. Pati ents were considered to be infected with H. pylori if at least 2 of the 4 r eference tests were positive. Stool samples were aliquoted after reception and stored frozen (-20 degreesC) until tested. The FemtoLab H. pylori (TM) (Connex GmbH, Germany) and the Premier Platinum HpSA EIA (TM) (Meridian, Co nnecticut, Ohio, USA) were performed according to the manufacturers protoco ls. Results: 26 of the 53 patients were H. pylori infected. 3 were false-ne gative by the FemtoLab H. pylori (TM) and one false-positive result was obt ained (sensitivity 88,5%, specificity 96,3%). The concordance between the 2 stool tests was 94,3 % (50/53 cases). Conclusion: The diagnostic quality o f the novel FemtoLab H. pylori (TM) Enzyme Immunoassay is comparable with t he established Premier Platinum HpSA EIA (TM). The differences between posi tive and negative results obtained with the FemtoLab H. pylori (TM) are gre ater in comparison to the Premier Platinum HpSA EIA (TM) and therefore this test system allows a better distinction.