A comparison of two rapid whole-blood tests and laboratory serology, in the diagnosis of Helicobacter pylori infection.

Objective: To compare two rapid whole-blood serology tests for Helicobacter pylori and a laboratory serology assay against a gold standard.

Design: Prospective comparison of tests in 81 patients.

Setting: A hospital rapid access endoscopy clinic.

Participants: Dyspeptic patients requiring assessment of H. pylori status.

Interventions: Measurement of H. pylori antibody status by Quickvue One-step, Helisal, and Premier H. pylori test; 13C urea breath test for H. pylori, and gastric biopsies for histology, culture and rapid urease test.

Main Outcome Measure: Sensitivity and specificity of Quickvue One-step, Helisal and Premier tests, compared to a gold standard based on 13C urea breath test, biopsy culture, histology and urease test.

Results: The Quickvue assay has significantly greater sensitivity (81%) than Helisal (67%), but without appreciable loss of specificity (86% and 93%, respectively). The Premier laboratory assay is significantly more sensitive than both of the rapid blood tests (96%), with comparable specificity to the Quickvue assay.

Conclusion: The rapid serology tests used in this study are quick and convenient to use, but do not approach the sensitivity of a laboratory assay in detecting H. pylori status in this group of dyspeptic patients attending an endoscopy clinic.