A Comparison of Accuracy between IMMULITE2000® and GENEDIA® for Helicobacter pylori Infection

Abstract

Background/Aims: In serological tests for <i>Helicobacter pylori</i> (<i>H. pylori</i>), an enzyme-linked immunosorbent assay (GENEDIA^®) and a solid-phase, two-step chemiluminescent enzyme immunoassay (IMMULITE^®), which are easy to perform, inexpensive, and widely available, are commonly used. However, local validation of the test performance of IMMULITE^® is required. This study aimed to examine the performance of IMMULITE^® in comparison with that of GENEDIA^® in a Korean health checkup population.Materials and Methods: The sera of 300 subjects among those who underwent health checkup were analyzed using IMMULITE^®, and results were compared with those of GENEDIA^®. The two serological tests were compared for their ability to predict atrophic gastritis (AG) or intestinal metaplasia (IM) on endoscopy.Results: We found significant correlation (Pearson correlation coefficient=0.903, <i>P</i><0.0001) and an almost perfect agreement (Cohen’s Kappa coefficient=0.987, <i>P</i><0.0001) between the results of GENEDIA^® and IMMULITE^®. The area under the receiver operating characteristics curve (AUC) for AG using GENEDIA^® and IMMULITE^® were 0.590 and 0.604, respectively, and showed no statistically significant difference in predictive ability for AG (<i>Z</i>-statistics=-0.517, <i>P</i>=0.605). The AUC for IM by GENEDIA^® and IMMULITE^® were 0.578 and 0.593, respectively, with no statistically significant difference in predictive ability for IM between the two values (<i>Z</i>-statistics=-0.398, <i>P</i>=0.691).Conclusions: No statistically significant difference in diagnostic value for <i>H. pylori</i> infection was found between GENEDIA^® and IMMULITE^®.