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.
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.
Siekmann
Lothar
L
Institut für Klinische Biochemie, Universität Bonn, Germany.
Bonora
Roberto
R
Burtis
Carl A
CA
Ceriotti
Ferruccio
F
Clerc-Renaud
Pascale
P
Férard
Georges
G
Ferrero
Carlo A
CA
Forest
Jean-Claude
JC
Franck
Paul F H
PF
Gella
F-Javier
FJ
Hoelzel
Wieland
W
Jørgensen
Poul Jørgen
PJ
Kanno
Takashi
T
Kessner
Art
A
Klauke
Rainer
R
Kristiansen
Nina
N
Lessinger
Jean-Marc
JM
Linsinger
Thomas P J
TP
Misaki
Hideo
H
Mueller
Mathias M
MM
Panteghini
Mauro
M
Pauwels
Jean
J
Schiele
Françoise
F
Schimmel
Heinz G
HG
Vialle
Arlette
A
Weidemann
Gerhard
G
Schumann
Gerhard
G
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
D004798:Enzymes; D007770:L-Lactate Dehydrogenase; D005723:gamma-Glutamyltransferase; D000410:Alanine Transaminase; D003402:Creatine Kinase