Abstract
Objective: The aim of our study was to evaluate the diagnostic performance of a rapid serological test ELISA (Pylorix (R)) in patients seen in digestive endoscopy using as reference histology.
Patients and methods: This is a prospective case-control study was conducted at the University Hospital of Cocody about 3 months. Were included 88 patients aged 14 to 78 years old received for performing upper endoscopy. In each of them, we applied the test Pylorix (R) and systematically realized five gastric biopsies (3 antrals and fundic 2) for looking for Helicobacter pylori at Histology (reference test to judge the performance of serological test used). Based on test results, patients were divided into two groups, i.e. case group (Pylorix (R) test positive) and control group (Pylorix (R) test negative). Case and control groups were compared according to the histology result.
Results: The average age of our patients was 40.5 +/- 16.9 years with a median of 35 years. The sex-ratio was 1.75 for women. Ten of 88 patients (11.4%) had taken anti-ulcer at least 30 days before endoscopy. The epigastric pain was the main ground for review with 61.8% of cases. Endoscopically, no lesions were objectified in 75% and 61.8% respectively in the fundus and antrum. The erythematosus aspect was the most frequent lesion with 14.8% of cases in the fundus and 21.6% in the antrum. The Pylorix test used was positive in 40.9% of cases, while in histology prevalence was 54.5%. Compared to histology, the performances of the Pylorix (R) were: Se: 52.1%, Sp: 72.5%, PPV 69.4%, VPN: 55.8%. But these performances improved in patients without anti-ulcer and / or antibiotics, while they remained poor in those who had taken.
Conclusion: The Pylorix (R) test used in our study shows poor performance. Therefore, it can not be recommended in our current practices.