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Comparative Study
. 2025 Jan;133(1):e13483.
doi: 10.1111/apm.13483. Epub 2024 Oct 25.

Evaluation of five different methods for diagnosis of Helicobacter pylori from fecal samples

Jenni Horsma-Heikkinen  1 , Anu Pätäri-Sampo  1 , Tanja Holma  1 , Annika Nevalainen  1 , Nathalie Friberg  1 , Hanna Jarva  1 , Raisa Loginov  1 , Jenni Antikainen  1
Affiliations
Comparative Study

Evaluation of five different methods for diagnosis of Helicobacter pylori from fecal samples

Jenni Horsma-Heikkinen et al. APMIS. 2025 Jan.

Abstract

Accurate detection of Helicobacter pylori and its antimicrobial resistance is essential for eradication of the infections. The aim of this study was to compare five different CE-IVD marked assays in detection of H. pylori from 268 clinical stool samples. Samples were considered positive for H. pylori when at least three of the five tests were positive. Amplified IDEIA Hp StAR (Oxoid) and Premier Platinum HpSA PLUS (Meridian Bioscience Inc.) assays showed sensitivity of 100% [95% CI (confidence interval): 87-100] and LIAISON® Meridian H. pylori SA (DiaSorin) of 83.3% (95% CI: 66-93). Specificities of the assays were 94.5% (95% CI: 91-97), 95.4%; (95% CI: 92-97), and 97.1% (95% CI: 94-99) respectively. Amplidiag® H. pylori + ClariR (Mobidiag) assay showed 93.3% (95% CI: 78-99) and Allplex™ H. pylori & ClariR Assay (Seegene Inc.) 36.7% (95% CI: 22-55) sensitivity, while specificity of both was 97.9% (95% CI: 95-99). The Amplidiag® and Allplex™ assays concordantly detected clarithromycin resistance in positive for H. pylori samples. The Amplidiag® assay showed the highest accuracy, namely 97.4% (95% CI: 95-99). These data provide helpful information for planning laboratory diagnostics of H. pylori and detection of clarithromycin resistance from stool samples.

Keywords: Helicobacter pylori; antigen test; clarithromycin; molecular diagnostics; stool sample.

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