[Comparative study of four commercialized serologic methods for the diagnosis of gastric Helicobacter pylori infection].

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.