OBJECTIVE: Four commercially available enzyme-linked immunosorbent assays (ELISA) were evaluated for serological diagnosis of Helicobacter pylori (H. pylori) infection in 79 untreated patients. METHODS: Infection has been diagnosed in 40 patients, in whom culture and/or urease test and histopathology from antral biopsies, were positive for H. pylori. RESULTS: Sensitivity (Se) and specificity (Sp) of these tests, calculated with indeterminate serological results (9 patients) classified as positive (ind +) or negative (ind -), were not statistically different: GAP-test (Bio-Rad), Se = 95% (ind +), 90% (ind -), Sp = 84.6% (ind +), 89.7% (ind -); Pylori-Stat (Biowhittaker), Se = 97.5% (ind + or -), Sp = 71.8% (ind +), 71.9% (ind -); Premier H. pylori (Biomedical Diagnostics), Se = 92.5% (ind +), 90% (ind -), Sp = 84.6% (ind +), 81.2% (ind -); Cobas-Core (Roche), Se = 92.5% (ind + or -), Sp = 76.9% (ind +), 79.5% (ind -). There was a strong correlation between mucosal inflammation and H. pylori status. Discrepancies between infectious status and at least one serology result were observed in 16 patients (11 H. pylori negative and 5 H. pylori positive patients). CONCLUSION: These 4 tests are of equivalent diagnostic value. Thus, the selection of one of them should take into account cost and practicability.
OBJECTIVE: Four commercially available enzyme-linked immunosorbent assays (ELISA) were evaluated for serological diagnosis of Helicobacter pylori (H. pylori) infection in 79 untreated patients. METHODS: Infection has been diagnosed in 40 patients, in whom culture and/or urease test and histopathology from antral biopsies, were positive for H. pylori. RESULTS: Sensitivity (Se) and specificity (Sp) of these tests, calculated with indeterminate serological results (9 patients) classified as positive (ind +) or negative (ind -), were not statistically different: GAP-test (Bio-Rad), Se = 95% (ind +), 90% (ind -), Sp = 84.6% (ind +), 89.7% (ind -); Pylori-Stat (Biowhittaker), Se = 97.5% (ind + or -), Sp = 71.8% (ind +), 71.9% (ind -); Premier H. pylori (Biomedical Diagnostics), Se = 92.5% (ind +), 90% (ind -), Sp = 84.6% (ind +), 81.2% (ind -); Cobas-Core (Roche), Se = 92.5% (ind + or -), Sp = 76.9% (ind +), 79.5% (ind -). There was a strong correlation between mucosal inflammation and H. pylori status. Discrepancies between infectious status and at least one serology result were observed in 16 patients (11 H. pylori negative and 5 H. pylori positive patients). CONCLUSION: These 4 tests are of equivalent diagnostic value. Thus, the selection of one of them should take into account cost and practicability.