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Detection of Shiga toxin-producing and other diarrheagenic Escherichia coli by the BioFire FilmArray® Gastrointestinal Panel in human fecal samples

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Abstract

The purpose of this investigation was the evaluation of the performance of the BioFire FilmArray® Gastrointestinal (FA-GI) Panel, a multiplexed molecular stool screening assay, for the detection of diarrheagenic Escherichia coli (DEC), with emphasis on Shiga toxin-producing E. coli (STEC). A dilution series of 12 STEC reference strains was tested with the FA-GI Panel to assess the analytical sensitivity. A total of 389 patient samples were analyzed with the FA-GI Panel and confirmation of the detected DEC was attempted with an in-house culture-based polymerase chain reaction (PCR) method. All Shiga toxin genes, except the one encoding Stx2f, were detected in bacterial dilutions ranging from 104 to 102 colony-forming units (CFU)/ml. eae + stx2f + STEC was misclassified as enteropathogenic E. coli (EPEC). Different sensitivities for various gene targets present in one isolate led to differing identifications depending on the concentration. Using the in-house method as a reference, the FA-GI Panel had a sensitivity of 90.6 % [confidence interval (CI) 75.0 %–98.0 %] and a specificity of 97.2 % (CI 94.9 %–98.6 %) for STEC detection in feces. At least one DEC was reported in 35.5 % (171/389) of the patient specimens, with EPEC being the most prevalent (n = 71). Only 59.7 % of the detected DEC could be confirmed, presumably because the comparator method was not applied directly on feces. The FA-GI Panel could not detect the stx2f subtype, misclassified certain pathogens, and the high detection rate of EPEC needs further investigation. Nevertheless, we believe that this sensitive and convenient system will prove to be an invaluable tool for the rapid diagnosis of most DEC infections, but culturing of the detected microorganisms should always be attempted.

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Acknowledgments

K. De Rauw contributed to the study design, execution of the experiments, analysis and interpretation of the data, and writing of the manuscript. L. Detemmerman contributed to the execution of the experiments, analysis and interpretation of the data, and writing of the manuscript. J. Breynaert contributed to the execution of the experiments. D. Piérard contributed to the study design, analysis and interpretation of the data, and writing of the manuscript.

We gratefully thank bioMérieux (France) for providing the FilmArray instrument and the Gastrointestinal Panel test kits for this study.

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Correspondence to K. De Rauw.

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For this type of study, formal consent is not required.

Funding information

Part of this work was performed in the frame of the Belgian National Reference Centre for STEC supported by the Belgian Ministry of Social Affairs through a fund within the Health Insurance System. The FilmArray instrument and the Gastrointestinal Panel test kits for this study were provided by bioMérieux (France).

Conflict of interest

This study was accomplished thanks to the support of the company bioMérieux (France), who supplied us with the needed FilmArray instrument and the Gastrointestinal Panel test kits. However, the company did not have any involvement in the study design; in the acquisition, analysis, and interpretation of the data; in the writing of the manuscript; and in the decision to submit the article for publication. Therefore, we declare that there are no conflicts of interest.

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De Rauw, K., Detemmerman, L., Breynaert, J. et al. Detection of Shiga toxin-producing and other diarrheagenic Escherichia coli by the BioFire FilmArray® Gastrointestinal Panel in human fecal samples. Eur J Clin Microbiol Infect Dis 35, 1479–1486 (2016). https://doi.org/10.1007/s10096-016-2688-7

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  • DOI: https://doi.org/10.1007/s10096-016-2688-7

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