Diagnostic Value of the Pylori DuoTect Test for Helicobacter pylori Detection in the Vietnamese Population.

OBJECTIVES: To evaluate the diagnostic accuracy in Helicobacter pylori detection using blood test with FliD and CagA antibodies (Pylori DuoTect), comparing with rapid urease test (RUT) and urease breath test (UBT) in Vietnamese patients with upper GI symptoms. METHODS: A cross-sectional study was conducted at the Institute of Gastroenterology and Hepatology in Hanoi, Vietnam on adults with upper GI symptoms, no prior treatment of peptic ulcers, and no history of H. pylori infection. Participants underwent upper GI endoscopy and three H. pylori tests, including rapid urease test (RUT), urea breath test (UBT), and Pylori DuoTect. Pylori DuoTect was considered positive if either FliD or CagA antibodies were detected. The H. pylori infection was defined as both RUT and UBT positive. Endoscopic findings were classified using the Kyoto classification score for gastritis. Diagnostic accuracy was evaluated using sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). RESULTS: From December 1, 2023, to August 9, 2024, 333 patients were recruited (mean age 45.9 years, 39.9% male). The most common symptom was epigastric pain (49.5%). The prevalences of gastritis, gastric ulcers, and duodenal ulcers were 92.7%, 12.1%, and 8.1%, respectively. Pylori DuoTect was positive in 51.9% of patients (FliD: 34.8% and CagA: 66.6%). Using the gold standard, 33.6% were diagnosed with H. pylori infection. The sensitivity, specificity, PPV, and NPV of Pylori DuoTect were 83.0%, 64.0%, 54.0%, and 88.0%, respectively. Combining Pylori DuoTect and endoscopy findings (peptic ulcer or Kyoto score ≥ 2) improved the sensitivity from 0.83 to 0.88 and increased NPV. CONCLUSION: Pylori DuoTect had moderate sensitivity and low specificity in the diagnosis of H. pylori infection in Vietnamese adult patients.