title: IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 degrees C. International Federation of Clinical Chemistry and Laboratory Medicine. Part 7. Certification of four reference materials for the determination of enzymatic activity of gamma-glutamyltransferase, lactate dehydrogenase, alanine aminotransferase and creatine kinase accord.
abstract: This paper is the seventh in a series dealing with reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 degrees C and the certification of reference preparations. Other parts deal with: Part 1. The Concept of Reference Procedures for the Measurement of Catalytic Activity Concentrations of Enzymes; Part 2. Reference Procedure for the Measurement of Catalytic Concentration of Creatine Kinase; Part 3. Reference Procedure for the Measurement of Catalytic Concentration of Lactate Dehydrogenase; Part 4. Reference Procedure for the Measurement of Catalytic Concentration of Alanine Aminotransferase; Part 5. Reference Procedure for the Measurement of Catalytic Concentration of Aspartate Aminotransferase; Part 6. Reference Procedure for the Measurement of Catalytic Concentration of Gamma-Glutamyltransferase. A document describing the determination of preliminary reference values is also in preparation. The certification of the catalytic activity concentrations as determined by the recently elaborated IFCC primary reference methods at 37 degrees C of four enzyme preparations, namely IRMM/IFCC 452 (gamma-glutamyltransferase), IRMM/IFCC 453 (lactate dehydrogenase 1), IRMM/IFCC 454 (alanine aminotransferase) and IRMM/IFCC 455 (creatine kinase) is described. Homogeneity data were derived from previous results. Stability was assessed using recently obtained data as well as data from previous stability studies. The collaborative study for value assignment was performed under a strict quality control scheme to ensure traceability to the primary reference method. Uncertainty of the materials was assessed in compliance with the Guide to the Expression of Uncertainty in Measurement. The certified values obtained at 37 degrees C are 1.90 microkat/l +/- 0.04 microkat/l (114.1 U/l +/- 2.4 U/l), for gamma-glutamyltransferase, 8.37 microkat/l +/- 0.12 microkat/l (502 U/l +/- 7 U/l), for lactate dehydrogenase 1, 3.09 microkat/l +/- 0.07 microkat/l (186 U/l +/- 4 U/l), for alanine aminotransferase and 1.68 microkat/l +/- 0.07 microkat/l (101 U/l +/- 4 U/l), for creatine kinase. The materials are intended for internal quality control as well as for the evaluation of test systems as required by recent European Union legislation. Furthermore, the materials can be used to transfer accuracy from a reference method to a routine procedure provided the procedures exhibit the same analytical specificity and the certified materials are commutable.
authors.affiliation: Institut für Klinische Biochemie, Universität Bonn, Germany.
authors.forename: Lothar
authors.initials: L
authors.lastname: Siekmann
authors.forename: Roberto
authors.initials: R
authors.lastname: Bonora
authors.forename: Carl A
authors.initials: CA
authors.lastname: Burtis
authors.forename: Ferruccio
authors.initials: F
authors.lastname: Ceriotti
authors.forename: Pascale
authors.initials: P
authors.lastname: Clerc-Renaud
authors.forename: Georges
authors.initials: G
authors.lastname: Férard
authors.forename: Carlo A
authors.initials: CA
authors.lastname: Ferrero
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Forest
authors.forename: Paul F H
authors.initials: PF
authors.lastname: Franck
authors.forename: F-Javier
authors.initials: FJ
authors.lastname: Gella
authors.forename: Wieland
authors.initials: W
authors.lastname: Hoelzel
authors.forename: Poul Jørgen
authors.initials: PJ
authors.lastname: Jørgensen
authors.forename: Takashi
authors.initials: T
authors.lastname: Kanno
authors.forename: Art
authors.initials: A
authors.lastname: Kessner
authors.forename: Rainer
authors.initials: R
authors.lastname: Klauke
authors.forename: Nina
authors.initials: N
authors.lastname: Kristiansen
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Lessinger
authors.forename: Thomas P J
authors.initials: TP
authors.lastname: Linsinger
authors.forename: Hideo
authors.initials: H
authors.lastname: Misaki
authors.forename: Mathias M
authors.initials: MM
authors.lastname: Mueller
authors.forename: Mauro
authors.initials: M
authors.lastname: Panteghini
authors.forename: Jean
authors.initials: J
authors.lastname: Pauwels
authors.forename: Françoise
authors.initials: F
authors.lastname: Schiele
authors.forename: Heinz G
authors.initials: HG
authors.lastname: Schimmel
authors.forename: Arlette
authors.initials: A
authors.lastname: Vialle
authors.forename: Gerhard
authors.initials: G
authors.lastname: Weidemann
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schumann
mesh_terms: D000410:Alanine Transaminase / Q000032:analysis / Q000592:standards; D004796:Clinical Enzyme Tests / Q000379:methods / Q000592:standards; D003402:Creatine Kinase / Q000032:analysis / Q000592:standards; D004798:Enzymes / Q000032:analysis / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D007770:L-Lactate Dehydrogenase / Q000032:analysis / Q000592:standards; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D005723:gamma-Glutamyltransferase / Q000032:analysis / Q000592:standards
chemical_list: D004798:Enzymes; D007770:L-Lactate Dehydrogenase; D005723:gamma-Glutamyltransferase; D000410:Alanine Transaminase; D003402:Creatine Kinase