title: [In-house PCR practical knowledge: a sufficient validation according to NF EN ISO 15189?].
abstract: As far as molecular biology is concerned, numerous are laboratories using in-house method. Used since many years, medical biologists have often a good practical knowledge about them. According to ISO 15189 accreditation, is this knowledge sufficient for the validation of these methods? We have asked this question ourselves about our in-house Leishmaniasis PCR.
authors.affiliation: Laboratoire de biologie médicale, HIA Legouest, France. serge.vedy@santarm.fr
authors.forename: Serge
authors.initials: S
authors.lastname: Védy
authors.forename: Aude
authors.initials: A
authors.lastname: Valois
authors.forename: David
authors.initials: D
authors.lastname: Budzilawski
authors.forename: Pascale
authors.initials: P
authors.lastname: Perez
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Puyhardy
mesh_terms: D000068:Accreditation / Q000331:legislation & jurisprudence* / Q000592:standards; D001800:Blood Specimen Collection / Q000592:standards; D002983:Clinical Competence / Q000331:legislation & jurisprudence / Q000592:standards; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D016773:Leishmaniasis, Cutaneous / Q000097:blood / Q000175:diagnosis* / Q000235:genetics; D017056:Medical Laboratory Personnel / Q000193:education / Q000331:legislation & jurisprudence / Q000592:standards; D008828:Microbiological Techniques / Q000592:standards; D016133:Polymerase Chain Reaction / Q000592:standards*; D011364:Professional Practice / Q000592:standards*; D012680:Sensitivity and Specificity; D054928:Validation Studies as Topic
keywords: ISO 15189; PCR; in-house; leishmaniasis