Background: Near patient tests for Helicobacter pylori were developed to assist in the management of dyspepsia patients in general practice. Most studies were performed in western populations.
Aim: To evaluate the rapid whole blood test (Flexpack HP) for H. pylori in the Chinese population.
Methods: Consecutive dyspeptic patients referred for upper endoscopy were recruited. During upper endoscopy, biopsies were taken from the antrum and corpus for rapid urease test (CLO test) and histological examination. After endoscopy, the whole blood test (FlexPack HP) was performed according to the manufacturer's instruction. Patients then received a 13C-urea breath test. Results of the whole blood test were compared with the gold standard (CLO test, histology and 13C-urea breath test).
Results: A total of 294 consecutive patients gave a valid Flexpack HP result for interpretation. The mean age of patients was 47.7 (range 15-85) years. Analysis showed a sensitivity, specificity, positive predictive value, negative predictive value and accuracy of 58%, 92%, 91%, 63% and 73% respectively.
Conclusion: The FlexPack HP whole blood test showed good specificity but lacked sensitivity. It is not sensitive enough to be used in a general practice setting for the test-and-treat approach in the Chinese population.