Comparison of helisal rapid blood test and ¹⁴C-urea breath test in determining Helicobacter pylori status and predicting ulcer disease in dyspeptic patients

Objective: Noninvasive tests for Helicobacter pylori are used increasingly. Our aim was to compare the Helisal Rapid Blood (HRB) test and ¹⁴C-urea breath test (UBT) for determining H. pylori status and predicting ulcer disease. Methods: Three hundred fifty-one consecutive patients with dyspepsia (mean age 40 yr; range 16-77 yr) had an HRB test and UBT followed by endoscopy with biopsies of the antrum and body for histology and antral urease slide test (CLO test). Patients were excluded if they had previously confirmed ulcer disease, gastric surgery, or anti-H. pylori therapy or were taking nonsteroidal anti-inflammatory drugs. Results: Sixty-three percent of the patients were 'gold standard' H. pylori positive (positive CLO test, positive staining), 34% were gold standard negative (negative CLO test, negative staining), and 3% had conflicting CLO test and histology. The UBT was superior to HRB for determining H. pylori status (sensitivity 98% vs 92%, p = 0.04; specificity 100% vs 69%, p < 0.001). The specificity of the HRB decreased with increasing patient age (74% for age <46 yr; 57% for age ≥46 yr). A negative UBT was superior to a negative HRB test for predicting the absence of ulcer disease (47% vs 36%; p < 0.01). A positive UBT was similar to a positive HRB in predicting the presence of ulcer disease (92% vs 84%; p = 0.23). Conclusions: The HRB test is inferior to the UBT for determining H. pylori status. The tests have a similar ability to predict the presence of ulcer disease when positive, but a negative UBT is a better predictor of the absence of ulcer disease.