Accuracy of GenediaTM H. pylori ELISA for the Diagnosis of Helicobacter pylori Infection in Korean Population

Chung, In Sik; Kim, Sang Woo; Go, Jae Sung; Kim, Na Young; Kim, Jae Gyu; Kim, Jin Ho; Kim, Hak Yang; Kim, Jae Jun; Sim, Jae Geon; Roe, Im Hwan; Ahn, Hyeong Sik; Yoon, Byung Chul; Lee, Sang Woo; Lee, Yong Chan; Jung, Hwoon Yong; Hong, Won Seon; Choi, Kyoo Wan

Abstract

BACKGROUND: GenediaTM H. pylori ELISA is a newly developed diagnostic method which detects serum anti-H. pylori IgG antibody. The aim of this study was to assess the accuracy of GenediaTM H. pylori ELISA for the diagnosis of H. pylori infection in Korean population.
METHODS
GenediaTM H. pylori ELISA and GAP-IgG were performed in 353 adult sera and Pyloriset-IgG EIA in 184 subjects. In children, 43 serum samples were tested with GenediaTM H. pylori ELISA. H. pylori infection was determined by rapid urease test, histology, culture or 13C-urea breath test in adults. In children, the subject was considered to be H. pylori positive if 13C-urea breath test was positive.
RESULTS
In adults, the sensitivity and specificity of GenediaTM H. pylori ELISA were 93.2% and 83.5% with positive and negative predictive values of 85.1% and 92.5%. Those for GAP-IgG and Pyloriset-IgG EIA were 67.2%, 82.4%, 79.3%, 71.4% and 89.1%, 88.4%, 71.9%, 96.1%, respectively. In children, sensitivity, specificity, positive and negative predictive values of GenediaTM H. pylori ELISA were 80%, 84.8%, 61.5%, and 93.3%. Sensitivity and negative predictive value of GenediaTM H. pylori ELISA were significantly higher than those of GAP-IgG (93.2% vs. 67.2%; plt;0.005 and 92.5% vs 71.4%; p<0.005, respectively).
CONCLUSION
GenediaTM H. pylori ELISA is a relatively accurate method for the serodiagnosis of H. pylori infection in Korean subjects compared to GAP-IgG. These results may suggest the clinical use of GenediaTM H. pylori ELISA for epidemiological studies of H. pylori infection in Korea.