S. Kato et al., Urine-based enzyme-linked immunosorbent assay for the detection of Helicobacter pylori infection in children, PEDIATRICS, 107(6), 2001, pp. NIL_6-NIL_10
Objective. Serology and C-13-urea breath test have been widely used as noni
nvasive tests to detect Helicobacter pylori infection. However, easier coll
ection of samples and lower costs are desirable for diagnosis of the indivi
dual patient or for use in epidemiologic studies. Our aim was to study the
diagnostic accuracy of a recently developed urine-based enzyme-linked immun
osorbent assay (ELISA) kit for the detection of H pylori-specific immunoglo
bulin G (IgG) antibodies in children.
Study Design. Specimens of serum and randomly voided urine were collected f
rom 816 children (0-15 years old) and were analyzed using 2 serum-based ELI
SA kits and a urine-based ELISA kit, respectively. Based on results of sero
logy, the sensitivity, specificity, and accuracy of the urine-based ELISA k
it were evaluated. With regard to false-positive and false-negative results
, urinary IgG concentrations and IgG/creatinine levels were studied.
Results. Both serum-based ELISAs were positive in 41 children and were nega
tive in 666, who were enrolled in this study. The remaining 109 children we
re excluded because of disagreement between the results of the 2 serum-base
d ELISAs, including indeterminate values. Overall sensitivity, specificity,
and accuracy of urine-based ELISA test compared with serology were 85.4%,
95.5%, and 94.9%, respectively. On positivity rates, the urine-based ELISA
was closely coincident with the serum-based ELISA in each age group. There
was no correlation between antibody levels detected by urine-based ELISA an
d each serum-based ELISA. Urinary IgG concentrations and IgG/creatinine lev
els were significantly higher in false-positives and were lower in false-ne
gatives than in true-positives plus true-negatives for serology. Most of th
ose with false-positive results had trace to moderate proteinuria.
Conclusions. The urine-based ELISA is an alternative to serum-based ELISA f
or diagnosis of H pylori infection in children and should be suitable for l
arge-scale epidemiologic studies concerning the organism. In children with
proteinuria, results of the test should be interpreted with caution. It is
possible that the urine-based ELISA method would be applicable to diagnosis
of other infectious diseases.