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Master Thesis

Extension et accréditation d’un test commercial moléculaire pour le diagnostic des infections à Clostridioides difficile

Abstract : Clostridioides difficile is the major cause of healthcare-associated diarrhoea. Many different approaches are available for the laboratory detection of C. difficile infection (CDI). European guidelines recommend testing stool samples with a two-step algorithm including, first the detection of glutamate dehydrogenase (GDH) as a screening method and second the detection of toxins. Meridian Bioscience offers an algorithm using enzyme immunoassay (EIA) ImmunoCard® C. difficile GDH followed by a loop-mediated isothermal amplification Alethia C. difficile for toxin gene detection. Amplification inhibitors could impair the results. We developped and validated a toxigenic culture using Alethia if necessary. Implement CDI diagnosis algorithm accreditation according to the ISO 15189 standard is actually difficult for microbiologists. The French commit for the accreditation (COFRAC) produced some guides but did not show an example to follow. We suggest a pre-filled form for the validation of the Meridian Bioscience for CDI diagnosis.
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https://dumas.ccsd.cnrs.fr/dumas-02447413
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Cécile Juillard. Extension et accréditation d’un test commercial moléculaire pour le diagnostic des infections à Clostridioides difficile. Sciences du Vivant [q-bio]. 2019. ⟨dumas-02447413⟩

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