J Clin Pathol Qual Control.  2000 Jun;22(1):197-201.

Evaluation of Diagnostic Usefulness for Genedia(R) Helicobacter pylori ELISA

• Yang JH
• Lim YA
• Lee KB

Abstract

BACKGROUND: Helicobacter pylori (H. pylori) is known to be an important pathogen for gastritis, peptic ulcer, and gastric cancer. The serologic tests for the diagnosis of H. pylori infection are preferred because on non-invasiveness, simplicity, and rapidity. Many reagents for detecting antibodies of H. pylori are available in Korea, however, they are mostly foreign-made. Genedia(R) Helicobacter pylori ELISA (Green Cross, Korea) is a product made from Korean patients infected with the organism. Its effectiveness for the diagnosis of H. pylori infection, however, has not been well established. The authors, thus, evaluated the diagnostic usefulness of Genedia(R) Helicobacter pylori ELISA. METHOD: Two hundred fifty-four patients, whose gastric biopsies and serologic samples are available, were included for review. H. pylori was detected on histologic specimens stained with both the Hematoxylin-Eosin and Giemsa techniques. The serologic tests were carried out according to the insert of Genedia(R) Helicobacter pylori ELISA.
RESULTS
Compared with the findings of biopsies, Genedia(R) Helicobacter pylori ELISA has sensitivity of 96.2%, specificity of 56.8%, positive predictive value of 78.9%, negative predictive value of 90%, and efficacy of 81.5%. In 194 patients whose Genedia(R) Helicobacter pylori ELISA was positive and specimen absorbance/standard absorbance ratio was more than 2, H. pylori was found in 84.7% (133/157) of the biopsies. However, H. pylori was detected in only 54.1% (20/37) of the biopsies when the specimen absorbance/standard absorbance ratio was less than 2.
CONCLUSION
Genedia(R) Helicobacter pylori ELISA made in Korea is a useful screening test because of its low specificity and high sensitivity as well as high negative predictability. Specimen absorbance/standard absorbance ratio is also thought to be helpful in the diagnosis of H. pylori infection.

MeSH Terms

Antibodies
Biopsy
Diagnosis
Enzyme-Linked Immunosorbent Assay*
Gastritis
Helicobacter pylori*
Helicobacter*
Humans
Indicators and Reagents
Korea
Mass Screening
Peptic Ulcer
Sensitivity and Specificity
Serologic Tests
Stomach Neoplasms
Antibodies
Indicators and Reagents