Performance of current infection marker test for the diagnosis of Helicobacter pylori current infection: a multicenter clinical trial

Objective: To evaluate the performance of the ASSURE(TM) Helicobacter pylori (H. pylori) rapid test [current infection marker (CIM) kit, Genelabs Diagnostics] in detecting the current infection marker CIM for the diagnosis of H. pylori in adult patients.

Methods: For this multicenter and controlled clinical trial, a total of 300 patients with an average age of (41 ± 16) years old were recruited from 7 participating hospitals. There were 128 men and 172 women, never received any H. pylori eradication therapy. Each subject received a (13)C-urea breath test ((13)C-UBT) and a CIM test. Such performance parameters as sensitivity, specificity, positive and negative predictive values and accuracy were determined by (13)C-UBT for the diagnosis of current H. pylori infection.

Results: According to the gold standard, there were 131 positive and 169 negative subjects. The accuracy rate, sensitivity, specificity, positive and negative predictive values of CIM test were 89.0% (267/300), 87.8% (115/131), 89.9% (152/169), 87.1% (115/132) and 90.5% (152/168) respectively.

Conclusions: As a simple, rapid, accurate and affordable assay, CIM test may be useful for a non-invasive diagnosis of H. pylori infection in cases without eradication therapy.