Evaluation of an enzyme immunoassay for detecting Helicobacter pylori antigens in human stool samples

So far, the detection of Helicobacter pylori (Hp) infection by stool analysis appeared to be almost impossible. With the Premier Platinum HpSA EIA a new enzyme immunoassay was developed for diagnosis of Hp infection, using polyclonal antibodies against Hp antigens in human stool. We evaluated this new test in its diagnostic accuracy in comparison to established reference methods.

From 54 consecutive patients (29 male, 25 female, age: 19 to 85 years) undergoing routine upper gastrointestinal endoscopy antral and corpus biopsies were taken for histology and Helicobacter urease test (HUT). Endoscopy, 13C-urea breath test (13C-UBT), serology, and stool probes sampling were performed within two days. Stool samples were aliquoted after reception and stored frozen (-20 degrees C) until tested. The Premier Platinum HpSA test (Meridian, Connecticut, Ohio, USA) was performed according to the manufactures protocol. Patients were considered to be infected with Hp if two of the four reference tests were positive.

28 of the 54 patients were Hp-infected. Only one of these was found to be false-negative by the HpSA EIA. Two false-positive results were obtained in the noninfected group (sensitivity 96.4%, specificity 92.3%).

In this group of patients investigated, the novel HpSA Enzyme Immunoassay (EIA) proved to be highly accurate for diagnosis of Hp infection. Collection and testing of stool are noninvasive and easy to perform, therefore this test will become an important tool for diagnosing Hp infection in clinical practice.