In-practice evaluation of whole-blood Helicobacter pylori test: its usefulness in detecting peptic ulcer disease

Background. Approximately 10% of patients presenting with dyspepsia to the general practitioner have peptic ulcers; the large majority of which are re lated to infection with Helicobactor pylori, Office-based tests for H. pylo ri detection are generally validated and evaluated in selected patient grou ps. Aim. To evaluate the clinical effectiveness of a whole-blood serology test for infection with Helicobacter pylori in detecting peptic ulcer disease (P UD) in daily general practice. Method. A descriptive study of 171 primary care dyspepsia patients selected for open-access endoscopy in primary care and aged between 18 and 75 years , in 92 general practices in central, southern, and eastern parts of the Ne therlands. H. pylori status was assessed using the BM-test Helicobacter pyl ori, which is identical to the Helisal rest. Dyspepsia severity score was m easured using a validated symptom score. Symptom characteristics and probab ility of relevant disease were assessed by the general practitioner. Endosc opy was carried out in local hospitals, Diagnostic outcome of both endoscop y and tl. pylori reference test was supplied by local specialists, The BM-t est was evaluated against endoscopic results. Results, A high number (61.8%) of false-negative BM-tests resulted in a low sensitivity (95% confidence interval [CI] = 48-75%) for detection of H. py lori infection. Only 12 out of 32 patients with PUD had a positive BM-test, resulting in a positive likelihood ratio (LR) for PUD of 1.41 and a negati ve LR of 0.85. Conclusions This study confirms the relatively poor performance of the BM-t est in daily general practice, and shows the limited diagnostic value of H. pylori office-tests for detecting PUD in primary care. The discriminative value of the test result is too small to support either a 'test-and-endosco pe' or a "test-and-treat' strategy in general practice.