[Diagnosis of Helicobacter pylori infection in childhood with a novel immunoenzyme method (HpStAR) which detects antigens in feces using monoclonal antibodies ].

BACKGROUND

Premier Platinum HpSA EIA is an enzyme immunoassay developed for diagnosis of H. pylori infection using polyclonal antibodies against H. pylori in human stool. A new H. pylori stool antigen test, based on monoclonal antibodies, has been developed. Our aim was to evaluate prospectively the accuracy of the novel antigen stool test (DAKO HpStAR) using monoclonal antibodies for detection of H. pylori infection in children.

METHODS AND RESULTS

Total of 93 children undergoing upper gastrointestinal endoscopy were included in the study. Biopsy specimens were sampled from the gastric antrum and from the corpus. Patients were classified as H. pylori positive if histology and urease test were positive. All children provided a stool sample within 3 days after gastroscopy. IgG serology against H. pylori was also employed. HpStAR test was performed according to the manufacturers protocol. Results were read at 450/630 nm by spectrophotometry (cut-off point 0.150). Of the 93 children, 26 were H. pylori positive (13.1 +/- 3.2 yr), and 67 patients were H. pylori negative (12.8 +/- 4.7 yr). Only 2 children were misclassified (1 false negative, and 1 false positive). Sensitivity was 96.1%, specificity 98.5%, the positive and negative predicting values were 96.1% and 98.5%, respectively. Serology showed sensitivity 88.5%, specificity 70.2%; the positive and negative predicting values were 53.5% and 94% respectively.

CONCLUSION

HpStAR test based on monoclonal antibodies can be considered an accurate, non-invasive, reliable method for the diagnosis of H. pylori infection in children.