Background and aim: The performance of existing near patient tests for the diagnosis of Helicobacter pylori remains unsatisfactory. The aim of this study is to evaluate the accuracy of a new near patient test (Signify H. pylori) for the diagnosis of H. pylori and the usefulness of the Signify H. pylori test for a test and treat strategy.
Methods: Consecutive dyspeptic patients referred for upper endoscopy were recruited. Rapid urease test and histology were used as the gold standard. After endoscopy, blood was collected for the Signify H. pylori test and compared with a gold standard.
Results: Two hundred and forty-four patients were eligible for analysis and 121 (49.5%) were positive for H. pylori. The Signify H. pylori test showed a sensitivity, specificity, and accuracy of 84.3, 89.4%, and 86.9%, respectively, for whole blood and 79.3, 88.6, and 84.0% for serum, respectively. The sensitivity and specificity of the Signify H. pylori whole blood test was 87.5 and 92.6% for patients less than 45-years-old and the accuracy was similar between patients referred from primary care physicians or gastroenterologists. The test is easy to operate and results are available within 5 min.
Conclusion: The Signify H. pylori test is accurate for the near patient diagnosis of H. pylori infection.
Copyright 2002 Blackwell Publishing Asia Pty Ltd