title: [Microbiology method validation: illustration with Bact'Alert 3D].
abstract: As far as laboratories accreditation according to ISO 15189 is concerned, validation of each method used has to be achieved. Manufacturer's recommendations are not always helpful in this context. That's why each laboratory must proceed systematically to a logical risk analysis. Few publications are available on this subject concerning microbiology. We propose to illustrate it with the example of a blood culture automate: the Bact'Alert 3D commercialised by Biomérieux(®).
authors.affiliation: Laboratoire de biologie médicale, HIA Legouest, Metz. serge.vedy@santarm.fr
authors.forename: Serge
authors.initials: S
authors.lastname: Védy
mesh_terms: D000068:Accreditation / Q000331:legislation & jurisprudence / Q000592:standards*; D001769:Blood / Q000382:microbiology; D003666:Decontamination / Q000331:legislation & jurisprudence / Q000592:standards; D004780:Environment, Controlled; D006801:Humans; D007753:Laboratories / Q000331:legislation & jurisprudence* / Q000592:standards*; D008828:Microbiological Techniques / Q000592:standards*; D017410:Practice Guidelines as Topic; D011786:Quality Control; D012306:Risk; D013048:Specimen Handling / Q000592:standards; D054928:Validation Studies as Topic
keywords: ISO 15189; accreditation; blood culture; microbiology