Clinical Usefulness of Helicobacter pylori IgG Ab Assay: Comparison of Six Commercial Kits

Yong, Dongeun; Lee, Hyukmin; Kim, Hyon Suk; Lee, Joon Gu; Lee, Yong Chan

Abstract

BACKGROUND: The diagnostic significance of the serological detection of antibodies to Helicobacter pylori (H. pylori) has been reported by many investigators. But the comparison data between the various serological kits were not established in Korea.
METHODS
Forty nine patients with upper gastrointestinal symptoms were studied from June 1997 to September 1997 in Yonsei University College of Medicine, Severance hospital. Endoscopic gastric biopsy specimens were obtained for microscopic examination of the bacteria and rapid urease test (CLO test). The sera of these patients were obtained for the serological test at the same time. The six commercial kits (Cobas Core II, G.A.P. test IgG, PYLORAGEN, QuickVue, BIOCARD Helicobacter pylori IgG, EZ-H.P.) for the detection H. pylori antibodies were evaluated for diagnosis and screening of H. pylori infection.
RESULTS
Sensitivities for the six kits were from 71% to 96%, specificities were from 24% to 71%, positive predictive values were from 68% to 81%, negative predictive values were from 60% to 80%, respectively. There were statistically significant differences in four groups, between G.A.P. test and Cobas Core, G.A.P. test and PYLORAGEN, QuickVue and Cobas Core, QuickVue and PYLORAGEN.
CONCLUSIONS
Sensitivities and specificities obtained in different studies revealed as great differences in the results with the same kits as between the results obtained with different kits in the same study. So, the serologic method alone for the diagnosis of H. pylori infection is not recommended. But in the screening of H. pylori infection, it can be used, because sensitivities and negative predictive values are relatively high.