Evaluation of Diagnostic Usefulness for Genedia Helicobacter Pylori ELISA
Genedia Helicobacter pylori ELISA 시약의 임상적 유용성 검토
양, 진혁; 임, 영애; 이, 기범
Imsang pyŏngri wa chŏngdo kwanri, 22(1):197-202, 2000
Imsang pyŏngri wa chŏngdo kwanri; Journal of clinical pathology and quality control; 임상병리와 정도관리
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 of non-invasiveness, simplicity, and rapidity. Many reagents for detecting antibodies of H. pylori are available in Korea, however, they are mostly foreign-made. Genedia 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
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 technics. The serologic tests were
carried out according to the insert of Genedia Helicobacter pylori ELISA.
Result : Compared with the findings of biopsies, Genedia 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 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 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
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