Evaluation of SD BIOLINE rapid antibody test for diagnosis of Helicobacter pylori infection

Abstract

Helicobacter pylori infection is most prevalent and known to cause chronic gastritis and peptic ulcer disease in Ethiopia. To date, simple and rapid point-of-care tests are commercially available; however, information is limited regarding their diagnostic significance. This cross-sectional study was conducted to evaluate the diagnostic performance of SD BIOLINE H. pylori rapid antibody test. A consecutive 203 enzyme linked immunosorbent assay (ELISA) confirmed sera (148 H. pylori positive and 55 negative) from dyspeptic patients were tested using SD BIOLINE H. pylori kit (Standard Diagnostic Inc, Korea) at Hawassa Teaching and Referral Hospital, southern Ethiopia from October, 2012 to January, 2013. Individuals under 15 years old, who were on anti-H. pylori treatment during the month prior to the study, those with discordant ELISA results, and refused to participate, were excluded. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the SD BIOLINE H. pylori test kit were 95.3, 94.5, 97.9, 88.1 and 95.1%, respectively. Therefore, this point-of-care test could be used as alternative to ELISA testing and best fit our context.