Background. Premier Platinum HpSA EIAis 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 93c hildren 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 testwere positive. All children provided a stool samplewithin 3da ys 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 (l 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.
H. pylori, diagnosis, stool antigen, monoclonal antibodies, children.