A Comparison of Accuracy between IMMULITE2000® and GENEDIA® for Helicobacter pylori Infection
- Author:
Seon Hee LIM
1
;
Nayoung KIM
;
Sung Eun KIM
;
Gwang Ho BAIK
;
Ju Yup LEE
;
Kyung Sik PARK
;
Jeong Eun SHIN
;
Hyun Joo SONG
;
Dae-Seong MYUNG
;
Suck Chei CHOI
;
Hyun Jin KIM
Author Information
- Publication Type:Original Article
- From:The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2020;20(1):54-62
- CountryRepublic of Korea
- Language:Korean
-
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®.
