Abstract
BackgroundA number of noninvasive diagnostic tests are available to detect Helicobacter pylori infection. Data on serologic testing of children are lacking, however, and thus it remains unclear whether the serology cutoff points used for adults are appropriate for children.MethodsSerum and stool samples were obtained from 73 children who visited 5 hospitals in Japan between March 1993 and December 2009. Analysis of stool samples was carried out using an H pylori stool antigen enzyme-linked immunosorbent assay (HpSA ELISA), and serum antibodies to H pylori were examined using an antibody determination kit (E-Plate Eiken H pylori antibody). The validity of the serologic test was evaluated based on its sensitivity, specificity, and receiver operating characteristics curve.ResultsOf the 73 children included in this study, 34 were HpSA-positive and 39 were negative. Among the 34 HpSA-positive patients, 32 were IgG-positive and 2 were IgG-negative. Of the 39 patients who were HpSA-negative, 38 were IgG-negative and 1 was IgG-positive. The sensitivity, specificity, and positive likelihood ratio for IgG antibody testing were 91.2%, 97.4%, and 35.6, respectively, based on the recommended adult cutoff point of 10 U/ml. Among children, use of cutoff points in the range of 7 to 9 U/ml yielded optimal values for sensitivity and specificity, as well as a positive likelihood ratio.ConclusionsThe performance of the E-plate anti-H pylori IgG antibody test was comparable to that of the stool antigen test and is therefore suitable for epidemiologic studies of H pylori infection in large samples.
Highlights
IntroductionNumerous noninvasive diagnostic tests are available to detect H pylori infection, including serologic, stool antigen (HpSA), and 13C-urea breath testing.[9,10,11] Each test has strengths and weaknesses in terms of diagnostic accuracy, performance characteristics for the various samples collected in epidemiologic studies, and rapidity as a bedside diagnostic test
The prevalence of H pylori infection remains high among Japanese adults, a marked decrease has been observed among Japanese children.[5,6,7]
We compared the results of a serologic test and HpSA assay for H pylori infection in 73 Japanese children and found that the serologic test yielded excellent sensitivity and specificity, with the HpSA assay as the gold standard
Summary
Numerous noninvasive diagnostic tests are available to detect H pylori infection, including serologic, stool antigen (HpSA), and 13C-urea breath testing.[9,10,11] Each test has strengths and weaknesses in terms of diagnostic accuracy, performance characteristics for the various samples collected in epidemiologic studies, and rapidity as a bedside diagnostic test. The serologic test for H pylori infection can be done using stored sera in epidemiologic studies involving large samples; concerns regarding validity have been raised due to its lower sensitivity and specificity as compared with the stool antigen and urea breath tests.[12] there are few data on serologic tests for children, and it remains unclear whether the serology cutoffs used for adults are applicable to children. Conclusions: The performance of the E-plate anti-H pylori IgG antibody test was comparable to that of the stool antigen test and is suitable for epidemiologic studies of H pylori infection in large samples
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