Sensitivity and Specificity of an in-house Rapid Urease test for Detecting Helicobacter pylori Infection on Gastro-duodenal Biopsies in Sudan

Background: Helicobacter pylori (H. pylori) infection is commonlyassociated with chronic gastritis, peptic ulcer, and gastric carcinoma. This organism has a strong urease reaction due to a preformed enzyme; a characteristic that can be used for rapid detection of the pathogen. Objective: To assess the sensitivity and specificity of an in-house rapid urease test(iRUT) for detecting H. pylori Infection on gastro-duodenal biopsies in Sudan. Materials and methods: This was a descriptive, cross-sectional, qualitative study. 120 endoscopic biopsies were collected fromgastro-duodenal inflammation patients attending Fedheil Specialized Hospital (Khartoum, Sudan); during October to December, 2014. All biopsies were investigated by culture and iRUT; while culture results were proposed as gold standard. Results: Over a period of 3 month study, a total of 120 patients consisting of 59 males (49.2%) and 61 females (50.8%), aged >20 years with upper abdominal dyspeptic complaints referred for endoscopy. H. pylori was isolated from 70 patients (58.3%)after the cultivation of biopsy samples. 50 samples (41.7%) were negative. As regard the iRUT, 66 biopsy specimens (55.0%) were found positive for H. pylori and 54 specimens (45.0%) were found negative.The results of iRUT compared to culture results showed a sensitivity and specificity of 75.7% and 75.5% respectively.Cross tabulation of the iRUT and culture results showed 53 biopsy specimens (44.2%) were found positive for H. pylori by both iRUT and culture techniques; while 37 specimens (30.9%) were found negative by these two techniques. Conclusion: Our results indicate that the iRUT is a-sensitive, specific, simple, and cost effective test. It can be appropriately applied for detecting H. pylori infection in gastric biopsy specimens.