Performance and reproducibility of Pylori DuoTect® in a high Helicobacter pylori prevalence Latin American population.

BACKGROUND

An accurate, rapid, non-invasive test is critically needed for Helicobacter pylori infection, particularly in under-resourced populations at increased risk of gastric cancer.

AIMS: This study compared the performance of Pylori DuoTect® to a spectrum of other tests.

METHODS

Serum samples collected from Chilean adults with gastrointestinal symptoms who had undergone esophagogastroduodenoscopy were tested with the Pylori DuoTect® test for anti-FliD (flagellar hook-associated protein) and anti-CagA (cytotoxin-associated antigen gene A) antibodies, and compared to testing by urease, histology, whole-cell ELISA, CagA ELISA, and H. pylori-NAPPA array. We calculated sensitivity, specificity, and agreement based on Cohen's kappa statistic of the Pylori DuoTect® test to other tests.

RESULTS

Based on histology or rapid urease testing, 156 of 300 individuals (52%) were positive for H. pylori. Based on the Pylori DuoTect® test, 70 (45%) were seropositive for FliD, 94 (60%) for CagA, 127 (81%) for either FliD or CagA, and 37 (24%) for both. Sensitivity of either FliD or CagA detection for a positive H. pylori test by histology or urease testing was 81.1% and specificity was 29.2%. The Pylori DuoTect® test had the highest level of agreement with the CagA NAPPA and ELISA tests (81.3-82.0%).

CONCLUSIONS

The Pylori DuoTect® test showed high sensitivity but low specificity for H. pylori detection compared to histology or urease testing. However, it aligned well with performance of CagA detection. While this assay may hold promise based on ease of use, it requires additional optimization and validation to better define the performance characteristics across diverse, global populations.