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Retrospective and prospective evaluation of the FluoroType®-Mycobacteria VER 1.0 assay for the identification of mycobacteria from cultures in a French center

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European Journal of Clinical Microbiology & Infectious Diseases Aims and scope Submit manuscript

Abstract

Purpose

Rapid, reliable identification of mycobacteria from positive cultures is essential for patient management, particularly for the differential diagnosis of Mycobacterium tuberculosis complex (MTBC) and nontuberculous mycobacteria (NTM) species. The aim of the present study was to evaluate a new “In-Vitro-Diagnostic”-certified PCR kit, FluoroType®-Mycobacteria VER 1.0 (Hain Lifescience GmbH) for NTM and MTBC identification from cultures.

Methods

Mycobacteria identification isolated from positive cultures during routine practice at the Lyon university hospital mycobacteria laboratory obtained by hsp65 amplification/sequencing were compared retrospectively and prospectively to those obtained by and the FluoroType®-Mycobacteria VER 1.0 kit.

Results

The overall agreement between hsp65 amplification/sequencing and the FluoroType®-Mycobacteria VER 1.0 kit was 88.4% (84/95); 91.2% (52/57) for the retrospective period and 84.2% (32/38) for the prospective period. There were 9 (9.5%) minor discrepancies (species in the FluoroType®-Mycobacteria VER 1.0 database and identified at genus level): 4 during the retrospective period, 5 during the prospective period; and 2 (2.1%) major discrepancies (species in the FluoroType®-Mycobacteria VER 1.0 database and identified incorrectly to species level): 1 during the retrospective period (M. kumamotonense identified as M. abscessus subsp massiliense by the kit) and 1 during the prospective period (M. chimaera identified as M. smegmatis by the kit). Including concordant results at genus level and minor discrepancies, 17.9% (17/95) of strains were identified as Mycobacterium sp. by the FluoroType®-Mycobacteria-VER 1.0 kit.

Conclusion

The good performance of the FluoroType®-Mycobacteria-VER 1.0 kit with few major discrepancies could enable its use for first-line identification of positive mycobacteria cultures. However, an alternative identification method at least for reference laboratories is needed owing to the non-negligible proportion of NTM strains were identified at genus level.

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Data availability

The datasets generated during and analysed during the current study are available from the corresponding author on reasonable request.

Code Availability

Not applicable.

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Acknowledgements

The authors thank Philip Robinson (DRS, Hospices Civils de Lyon, Lyon, France) for help with manuscript preparation.

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The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.

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Authors and Affiliations

  1. Laboratoire des Mycobactérie, Laboratoire de biologie médicale multi-site, Groupement Hospitalier Nord, Hospices civils de Lyon, Lyon, France

    Lisa Piasecki, Charlotte Genestet, Yvonne Benito, Jean-Philippe Rasigade, Gérard Lina, Oana Dumitrescu & Elisabeth Hodille

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  1. Lisa Piasecki
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  2. Charlotte Genestet
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  3. Yvonne Benito
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  4. Jean-Philippe Rasigade
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  7. Elisabeth Hodille
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Contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Lisa Piasecki, Charlotte Genestet, Yvonne Benito, Jean-Philippe Rasigade, Gérard Lina, Oana Dumitrescu and Elisabeth Hodille. The first draft of the manuscript was written by Elisabeth Hodille and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

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Correspondence to Elisabeth Hodille.

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The present study was in accordance with the decision of the ethics committee of the Lyon university hospital, France (declared sample collection: DC-2011-1306). In accordance with French legislation, written informed patient consent was not required to compare the technical performance of assays with clinical specimens or clinical isolates collected following clinical recommendations.

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Piasecki, L., Genestet, C., Benito, Y. et al. Retrospective and prospective evaluation of the FluoroType®-Mycobacteria VER 1.0 assay for the identification of mycobacteria from cultures in a French center. Eur J Clin Microbiol Infect Dis (2024). https://doi.org/10.1007/s10096-024-04825-8

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