Comparison of two chemiluminescence assays for the detection of Helicobacter pylori antigen in stool samples.

INTRODUCTION

Non-invasive methods, particularly stool antigen detection, are widely employed for the diagnosis of Helicobacter pylori infection, and the evaluation of new diagnostic platforms is of practical interest. We evaluated the agreement between two chemiluminescence techniques, CLIA LIAISON® H. pylori SA and the recently developed H. pylori Ag VIRCLIA® Monotest.

METHODS

We analysed 200 stool samples from patients with suspected infection.

RESULTS

92 samples were positive and 94 negative in both tests. Of the discordant samples, 9 were positive by LIAISON® and negative by VIRCLIA®, and 5 were positive by VIRCLIA® and negative by LIAISON®. Overall agreement was 93.0%, positive percent agreement (PPA) was 92.9%, and negative percent agreement (NPA) was 93.1%. Kappa coefficient was 0.86 (95% CI 0.79-0.93; p<0.0001).

CONCLUSIONS

The VIRCLIA® assay demonstrated a high level of agreement with the LIAISON® assay for the detection of H. pylori stool antigen.