The evaluation of a new rapid stool antigen test showed different levels of sensitivity for final readings of test results at 20 min (59.1%) and 30 min (76.9%). Significant differences in performance were observed between the two sexes and the various age categories, with higher efficiency in male patients and young adults. Generally, this test is efficient and can be used to detect H. pylori infection in adults. However, further studies are required to confirm its accuracy.Helicobacter pylori is well recognized as a major cause of gastrointestinal diseases (10,11). Patients with successful eradication therapy show evidence for this cause-and-effect relationship; gastritis and ulcers often are cured, and the risk of recurrence is greatly reduced (4). Therefore, reliable detection of H. pylori infection is of major importance. In the last years interest has been focused on noninvasive methods, especially the detection of the pathogen in feces. The H. pylori stool antigen test provides a simple alternative to the urea breath test and is appropriate for diagnosis and follow-up of infection (3,9,11,12,14,(16)(17)(18). While the value of enzyme immunoassays (EIAs) using either polyclonal or monoclonal antibodies is well documented, the sporadic existing data for the first developed and commercially available rapid test (ImmunoCard STAT! HpSA) showed enormous differences among the studies (1,7,8,14,17), and its reliability is reported to be somewhat lower than that of monoclonal fecal antigen EIA (2, 9).Rapid Hp StAR (DakoCytomation Ltd., United Kingdom) is a newly developed qualitative immunochromatographic membrane-based assay using monoclonal antibodies and amplification technology for the direct detection of H. pylori antigens in human feces. The test has two capture lines, one coated with an H. pylori-specific amplified capture reagent (test line) and one with a control capture reagent (control line). A recent study reported good performance with posttreatment patients (14). No data are available on its reliability as a screening test for primary diagnosis. Moreover, the results of stool antigen tests may vary according to geographical locations (3, 9, 12). The objective of this trial was to evaluate the performance of this novel test with a group of dyspeptic adults in our region, in comparison to a well-defined H. pylori status established by invasive diagnostic methods. To determine sources of heterogeneity that may have an influence on applicability, the test was evaluated in relation to clinical manifestations and the ages and genders of the patients.(The results of this study were presented in part at the 17th European Congress of Clinical Microbiology and Infectious Diseases, Munich, Germany, 2007.) A total of 72 consecutive patients (37 females and 35 males) (mean age, 58.4 Ϯ 12 years; range, 24 to 88 years) who were referred to the Department of Surgery at the University Hospital of Kiel and to a gastroenterological private practice were enrolled in the study between 2002 and 2003. All patients who pre...