Evaluation of a new immunochromatographic based whole blood near patient test for the diagnosis of Helicobacter pylori infection.

BACKGROUND

Infection with H pylori is very common and may cause chronic gastritis, predisposes to gastric and duodenal ulcers, leads in some cases to gastric lymphoma and has been recognised as a class I gastric carcinogen. Rapid, inexpensive, reliable tests are needed to facilitate the diagnosis.

METHODS

This prospective clinical study was undertaken to evaluate a new whole blood antibody test (helicoCare) in correlation to three tests for diagnosis of H pylori infection (histology, ELISA and rapid urease test). 304 patients (mean age 56.5 years, range of 11-93 years) referred for esophagogastroduodenoscopy were included in this uni-centric study over a nine-month period. According to the guidelines for clinical trials in H pylori infection, patients with at least two positive tests were classified as positive for H pylori.

RESULTS

132 patients (43.4 %) were positive for H pylori, of which helicoCare identified 118 missing one gastric and one duodenal ulcer. 172 patients (56.6 %) were H pylori negative, of which helicoCare identified 163. Sensitivity was proven to be 89.4 % and specificity 94.8 %. In a special subgroup of 75 patients younger or equal to 45 years, 28 patients were positive for H pylori (37.3 %). In this group a sensitivity of 85.7 % and a specificity of 97.9 % was found for the helicoCare.

CONCLUSIONS

The helicoCare test showed sufficient sensitivity and satisfying specificity for H pylori diagnosis similar to or better than those of rapid urease test or ELISA. The helicoCare whole blood test may be useful for in-office H pylori diagnosis especially in patients under 45 years.