Korean J Helicobacter Up Gastrointest Res.  2020 Mar;20(1):54-62. 10.7704/kjhugr.2019.0014.

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

Affiliations
  • 1Department of Internal Medicine, Seoul National University Hospital Healthcare System Gangnam Center and Healthcare Research Institute, Seoul, Korea
  • 2Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
  • 3Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea
  • 4Department of Internal Medicine, College of Medicine, Hallym University, Chuncheon, Korea
  • 5Chuncheon, Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea
  • 6Department of Internal Medicine, Dankook University College of Medicine, Cheonan, Korea
  • 7Department of Internal Medicine, Jeju National University School of Medicine, Jeju, Korea
  • 8Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea
  • 9Department of Internal Medicine, Wonkwang University School of Medicine, Iksan, Korea
  • 10Department of Internal Medicine and Institute of Health Science, Gyeongsang National University School of Medicine, Jinju, Korea

Abstract

Background/Aims
In serological tests for Helicobacter pylori (H. pylori), 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, P<0.0001) and an almost perfect agreement (Cohen’s Kappa coefficient=0.987, P<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 (Z-statistics=-0.517, P=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 (Z-statistics=-0.398, P=0.691).
Conclusions
No statistically significant difference in diagnostic value for H. pylori infection was found between GENEDIA® and IMMULITE®.

Keyword

Enzyme-linked immunosorbent assay; ; Immunoenzyme techniques; Serology
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