Comparison of rapid office-based serology with formal laboratory-based ELISA testing for diagnosis of Helicobacter pylori gastritis.

Accurate and cost-effective diagnosis of Helicobacter pylori gastritis has taken on major importance. Several serologic tests for the diagnosis of H. pylori infection are commercially available. We compared the performance of the FlexSure HP rapid IgG antibody test with the conventional HM-CAP ELISA to evaluate whether qualitative office-based serology is reliable enough to replace formal laboratory-based testing. We assessed H. pylori status by concordance in 100 consecutive patients with antral biopsy, rapid urease, and 1 microCi[14C]urea breath tests. Both antibody tests had good sensitivity and specificity (>86%). Concordance between the two antibody tests occurred in 87/93 patients (94%). Based on our data, the office-based FlexSure HP performed equally well as the laboratory-based formal ELISA and may be a better choice for initial serologic diagnosis in untreated patients.