title: Recommendation for the review of biological reference intervals in medical laboratories.
abstract: This document is based on the original recommendation of the Expert Panel on the Theory of Reference Values of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), updated guidelines were recently published under the auspices of the IFCC and the Clinical and Laboratory Standards Institute (CLSI). This document summarizes proposals for recommendations on: (i) The terminology, which is often confusing, noticeably concerning the terms of reference limits and decision limits. (ii) The method for the determination of reference limits according to the original procedure and the conditions, which should be used. (iii) A simple procedure allowing the medical laboratories to fulfill the requirements of the regulation and standards. The updated document proposes to verify that published reference limits are applicable to the laboratory involved. Finally, the strengths and limits of the revised recommendations (especially the selection of the reference population, the maintenance of the analytical quality, the choice of the statistical method used…) will be briefly discussed.
authors.forename: Joseph
authors.initials: J
authors.lastname: Henny
authors.forename: Anne
authors.initials: A
authors.lastname: Vassault
authors.forename: Guilaine
authors.initials: G
authors.lastname: Boursier
authors.forename: Ines
authors.initials: I
authors.lastname: Vukasovic
authors.forename: Pika
authors.initials: P
authors.lastname: Mesko Brguljan
authors.forename: Maria
authors.initials: M
authors.lastname: Lohmander
authors.forename: Irina
authors.initials: I
authors.lastname: Ghita
authors.forename: Francisco A Bernabeu
authors.initials: FA
authors.lastname: Andreu
authors.forename: Christos
authors.identifier: http://orcid.org/0000-0002-5876-2599
authors.initials: C
authors.lastname: Kroupis
authors.forename: Ludek
authors.initials: L
authors.lastname: Sprongl
authors.forename: Marc H M
authors.initials: MH
authors.lastname: Thelen
authors.forename: Florent J L A
authors.initials: FJ
authors.lastname: Vanstapel
authors.forename: Tatjana
authors.initials: T
authors.lastname: Vodnik
authors.forename: Willem
authors.initials: W
authors.lastname: Huisman
authors.forename: Michel
authors.initials: M
authors.lastname: Vaubourdolle
mesh_terms: D002624:Chemistry, Clinical / Q000592:standards; D064790:Clinical Laboratory Services / Q000592:standards*; D006801:Humans; D007753:Laboratories / Q000592:standards*; D012015:Reference Standards