Evaluation of the Ez-HBT Helicobacter blood test to establish Helicobacter pylori eradication.

BACKGROUND The urea blood test (Ez-HBT) has been shown to compare favourably with the urea breath test in the diagnosis of active Helicobacter pylori infection. AIM To examine the performance characteristics of the Ez-HBT Helicobacter blood test in establishing success or failure of therapy in H. pylori-infected adults using the 13C urea breath test as the reference method. METHODS 13C urea breath test and Ez-HBT Helicobacter blood test were performed 4-6 weeks after completion of treatment in H. pylori positive subjects. Basal urea breath samples were collected; basal Ez-HBT Helicobacter blood test samples were not. Ez-HBT Helicobacter blood test results were reported as positive, negative, or indeterminate. RESULTS Seventy patients generated 126 measurable sets of urea breath and blood tests. The H. pylori cure rate was 93%. The sensitivity, specificity, and accuracy of the Ez-HBT Helicobacter blood test were 100%, 97%, and 97%, respectively. Six of eight false positive and indeterminate Ez-HBT Helicobacter blood test results could be attributed to incomplete fasting or a 13C enriched diet. After correcting for the non-fasting state, the positive predictive value of the Ez-HBT Helicobacter blood test improved from 56% to 86%. CONCLUSION The performance characteristics of the Ez-HBT Helicobacter blood test are comparable with that of 13C-urea breath test in establishing H. pylori eradication after therapy. Errors related to incomplete fasting can be mitigated by collection of a basal blood sample.