Evaluation of a new serologic test for diagnosis of Helicobacter pylori infection in children.

A new semiquantitative enzyme immunoassay (Platelia Helicobacter pylori; Sanofi Diagnostics Pasteur, France) was evaluated and compared with two other serological assays (Gap-test IgG; Bio-Rad, France; and Cobas Core; Roche, Switzerland) for the diagnosis of Helicobacter pylori infection in children. The three tests were compared with the examination of biopsy samples obtained from 160 dyspeptic subjects (mean age, 9 +/- 4.7 years). Discrepant results were studied using an immunoblot technique. The response obtained for the Platelia assay in children was significantly lower than that obtained in a previously described population of 92 adults (Helicobacter pylori-negative mean ratios, 0.376 vs. 0.504, P<0.000783; Helicobacter pylori-positive mean ratios, 1.95 vs. 2.67, P<0.000003). Thus, the optimal cut-off for children (0.80) was lower than the one recommended for adults (1.10). According to the Receiver Operating Characteristic (ROC) curve analysis and to the Wilcoxon value, the Platelia and Cobas Core assays showed the highest discriminatory properties (Wilcoxon value, 0.94 for both) compared with the Gap-test IgG (Wilcoxon value, 0.91). When the newly established cut-off value (0.80) was used, the performance of Platelia was equivalent to that of Cobas Core (sensitivity: 94.4% for each; respective specificities, 86.8% and 90.6%). The Gap-test IgG had a lower sensitivity (maximum, 79%) and a higher specificity (maximum, 95.3%), but there were difficulties in interpretation because its grey zone encompassed 12% of the sera. In conclusion, the results showed good performance of the Platelia Helicobacter pylori assay and confirmed the merit of a specific cut-off value for use of this test in children.