Korean J Gastroenterol.  2000 Jul;36(1):20-28.

A Comparison of Accuracy between A New Commercial ELISA Test, GenediaTM Test and Other Commercial ELISA Tests for Serological Diagnosis of Helicobacter pylori Infection in Korea

• Youn YH
• Shin SK
• Lee YC
• Moon BS
• Chon CY
• Moon YM
• Park IS

Abstract

BACKGROUND/AIMS
A new commercial enzyme linked immunosorbent assay (ELISA) test using Korean Helicobacter pylori (H. pylori) as an antigen, GenediaTM test, was compared to other serologic tests for H. pylori infection. METHODS: Among two hundred seventy three subjects, H. pylori-positive group was consisted of 132 patients (50 peptic ulcer diseases, 52 chronic gastritis, and 30 gastric cancers) and H. pylori-negative group was consisted of 141 patients (121 adults and 20 pediatric patients). Endoscopic antral biopsy specimens were obtained for microscopy and rapid urease test (CLOTM test). We also performed GenediaTM IgG, IgA ELISA, G.A.P IgG, IgA ELISA, and Cobas-core IgG EIA. H. pylori infection was defermined when H. pylori was detected histologically or the results of CLOTM tests were positive. RESULTS: The sensitivities and specificities of the serologic tests were 96.2% and 46.1% in GenediaTM IgG, 91.7% and 52.5% in GenediaTM IgA, 81.8% and 46.8% in G.A.P IgG, 25.0% and 85.1% in G.A.P IgA, 96.9% and 38.6% in Cobas-core test, respectively. In H. pylori-negative pediatric patients, the specificity of the tests was 80% in GenediaTM IgG, 95% in GenediaTM IgA, 60% in G.A.P. IgG, 100% in G.A.P IgA, and 75% in Cobas-core test. CONCLUSIONS: In Korea, GenediaTM test was comparable or superior to general serologic tests used for diagnosing H. pylori infection. However, it is necessary to improve the specificity of the GenediaTM test.

Keyword

Helicobacter pylori; Korean H. pylori; Serologic diagnosis; ELISA test; GenediaTM test; ELISA; GenediaTM

MeSH Terms

Adult
Biopsy
Diagnosis*
Enzyme-Linked Immunosorbent Assay*
Gastritis
Helicobacter pylori*
Helicobacter*
Humans
Immunoglobulin A
Immunoglobulin G
Korea*
Microscopy
Peptic Ulcer
Sensitivity and Specificity
Serologic Tests
Urease
Immunoglobulin A
Immunoglobulin G
Urease