Comparison of GastroPanel® and GENEDIA® in Diagnosing Helicobacter pylori Infection and Gastric Lesions.

Abstract

Serological tests for Helicobacter pylori needs local validation as the diagnostic accuracy may vary depending on the prevalence of H. pylori. This study examined the diagnostic performance of two ELISA, GastroPanel^® (GastroPanel ELISA; Biohit Oyj) and GENEDIA^® (GENEDIA^® H. pylori ELISA, Green Cross Co.) in Korean population. One thousand seventy seven patients who visited for esophagogastroduodenoscopy between 2013 and 2023 were prospectively enrolled, and serum samples from the subjects were tested using both GastroPanel^® and GENEDIA^®. The two tests were compared for their diagnostic accuracy in detecting atrophic gastritis (AG), intestinal metaplasia (IM), gastric adenoma (GA), and gastric cancer (GC), and the positivity rates by age and sex were observed. There was substantial correlation (Pearson coefficient [r] = 0.512, P < 0.001) and agreement (Cohen's Kappa coefficient [κ] = 0.723, P < 0.001) between the results obtained using GastroPanel^® and GENEDIA^®. The test results from the two kits did not match perfectly with a discrepancy observed in approximately 16% of cases, that 67 subjects were positive only on GENEDIA^® while 75 subjects were positive only on GastroPanel^®. The area under receiver operating characteristic curve for AG, IM, GA, and GC using GastroPanel^® were 0.666, 0.635, 0.540, and 0.575, while the results tested using GENEDIA^® were 0.649, 0.604, 0.553, and 0.555, respectively, without significant difference between the two results. GastroPanel^® and GENEDIA^® showed similar performance in terms of diagnostic accuracy; but the test results did not match perfectly. A large-scale validation study in Koreans is needed.