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EVALUATION OF MOLECULAR-BASED CLARITHROMYCIN RESISTANCE TESTING IN HELICOBACTER PYLORI COMPARED TO CULTURE-BASED TESTING IN THE IRISH HEALTHCARE SETTING

Stephen Molloy 1, Thomas Butler 1, Isabella Merrigan 1, Vikrant Parihar 2, Kevin Van Der Merwe 2, Deirdre McNamara 1,3, Sinead Smith 1,3

Affiliations

1 Trinity College Dublin, Dublin, Ireland

2 Letterkenny University Hospital, Letterkenny, Ireland

3 Tallaght University Hospital, Dublin, Ireland

Summary

AI Generated

A prospective Irish study comparing molecular and culture-based clarithromycin susceptibility testing in 191 H. pylori-positive patients found that the RIDA®GENE assay had 74.2% sensitivity and 94.7% specificity versus culture, with agreement in 84.3% of cases.

Culture-based methods detected clarithromycin resistance in 49.2% of patients versus 38.7% by molecular testing (P=0.05), with results agreeing in 84.3% of cases.
The RIDA®GENE assay showed 74.2% sensitivity (95% CI: 64.4-82.6%) and 94.7% specificity (95% CI: 88.0-98.3%) compared to culture and E-test as the reference standard.
Positive predictive value was 93.5% and negative predictive value was 78.1% for the molecular assay.
The molecular assay was faster and easier to use than culture but the authors suggest the low sensitivity may limit its use to cases where culture fails.
The study enrolled adults regardless of prior H. pylori treatment history from two Irish university hospitals, with biopsies from antrum and corpus analysed using EUCAST 2023 resistance criteria.

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This summary was generated by an AI large language model based on the content transcript. It is for informational purposes only and should not be considered a substitute for clinical judgment. Always rely on your professional expertise and the full clinical context when making clinical decisions.

Abstract

Introduction

Antibiotic resistance in H. pylori (Hp) is becoming a more significant challenge in the management of Hp infection. Resistance surveillance is recommended to guide clinicians in the most appropriate therapy in a given population. Molecular methods offer a more rapid alternative for the detection of Hp resistance to antibiotics than traditional culture-based methods.

Aims & Methods

To evaluate the diagnostic accuracy of molecular-based clarithromycin susceptibility testing in Hp compared to culture and E-test in the Irish healthcare setting.
Following ethical approval and informed consent, adults were recruited prospectively from 2 centres (Tallaght University Hospital and Letterkenny University Hospital, Ireland), regardless of previous Hp treatment history. During routine gastroscopy, subjects had two supplementary biopsies (1 antrum and 1 corpus) taken for Hp culturing and DNA extraction. After successful Hp growth, clarithromycin susceptibility testing was performed by the Etest (Biomerieux) method and resistance was determined according to EUCAST 2023 guidelines. DNA was then extracted from biopsies and underwent PCR using the RIDA®GENE Helicobacter pylori assay (R-Biopharm AG, Germany) for detection of Hp and clarithromycin resistance-associated point mutations (A2146C, A2146G and A2147G).

Results

In all, samples from 191 culture-positive patients (mean age 48.4 ± 15.3 years; 45.0% (N=86) female) were analysed. The rates of clarithromycin resistance detected by culture-based and molecular methods were 49.2% (N=94/191) and 38.7% (N=74/191), respectively (P=0.05; Fisher’s exact test). Results were in agreement between both methods in 84.3% (N=161/191) of cases. The sensitivity and specificity of the Ridagene assay compared to culture for the detection of clarithromycin resistance were 74.2% (95% CI: 64.4-82.6%) and 94.7% (95% CI: 88.0-98.3%), respectively. The positive predictive value was 93.5% (95% CI: 85.5-97.9%) and the negative predictive value was 78.1% (95% CI: 69.4-85.3%).

Conclusion

While the Ridagene assay was easy to use and more rapid than Hp culture, the low sensitivity compared to culture in our cohort may limit its use to cases where culture-based methods are unsuccessful. Further studies are required to characterise the full spectrum of clarithromycin resistance mechanisms present in our population.

Conference

UEG Week Copenhagen 2023

Topics

Stomach & H. Pylori

Submission format

Abstract

Session

PP 02 H. pylori (Posters)

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

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The role of nurses/technicians in performing endoscopic necrosectomy of peripancreatic collections

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