COMPARATIVE-STUDY OF 4 COMMERCIAL SEROLOG ICAL TESTS FOR THE DIAGNOSIS OF HELICOBACTER-PYLORI INFECTION

Objective. - Four commercially available enzyme-linked immunosorbent a ssays (ELISA) were evaluated for serological diagnosis of Helicobacter pylori (H. pylori) infection in 79 untreated patients. Methods. - Inf ection has been diagnosed in 40 patients, in whom culture and/or ureas e test and histopathology from antral biopsies, were positive for H. p ylori. Results. - Sensitivity (Se) and specificity (Sp) of these tests , calculated with indeterminate serological results (9 patients) class ified as positive (ind +) or negative (ind -), were not statistically different: GAP-rest (Bio-Rad), Se = 95 % (ind +), 90 % (ind -), Sp = 8 4.6 % (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 correlatio n between mucosal inflammation and H. pylori status. Discrepancies bet ween infectious status and at least one serology result were observed in 16 patients (11 H. pylori negative and 5 H. pylori positive patient s). Conclusion. - These 4 tests are of equivalent diagnostic value. Th us, the selection of one of them should take into account cost and pra cticability.