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BY THE IFCC:
AN OVERVIEW
JEAN-CLAUDE FOREST, MD, PhD, FRCPC, Chair, Scientific Division,
IFCC and CARL. A. BURTIS,
PhD, Past Chair, Scientific Division, IFCC.
Since its foundation, one of the main goals of the IFCC has been
to promote standardization in laboratory medicine. Over the years,
IFCC has sponsored the development of a great number of reference
methods for the measurement of constituents in biological fluids of
clinical significance and of primary and secondary reference
materials. More recently, IFCC has entered in a new phase of
involvement regarding standardization seeking international
collaboration with other organizations such as IRMM, NIST, NCCLS,
WHO, ISO, CEN and national societies and corporate members to
harmonize the various standardization activities around the world.
IFCC is now promoting actively the implementation of Reference
Systems in Laboratory Medicine based on the concept of traceability
and the monitoring of uncertainty, as outlined in the International
Vocabulary of Basic and General Terms in Metrology (VIM). Its
strategy is to encourage the establishment of a reference system
encompassing the development of reference methods, the production
of reference materials and the constitution worldwide of Networks
of Reference Laboratories.
As examples of reference methods achieved or currently under
development by Committees or Working Groups of the IFCC, one can
mention : reference method for the measurement of
HbA1c, reference procedures for the measurement of
catalytic activity concentrations of enzymes at 37 �C,
reference method for measurement of homocysteine, in vitro
diagnostic procedures in diagnosis and monitoring of thyroid
disease (ongoing project sponsored by the European Commission), to
name only a few. A number of reference materials have been
prepared : Plasma Proteins : CRM 470 ; Apolipoprotein
A1 : SP1, Apolipoprotein B : SP3 ; PSA Free : WHO
(free) 96/668 ; PSA Complexed : WHO (90 :10) 96/700 ;
Cortisol : IRMM/IFCC 451 ; Enzymes :
g-Glutamyltransferase : IRMM/IFCC 452 ; Enzymes : Human
Lactate Dehydrogenase Isoenzyme 1 : IRMM/IFCC 453 ;
Enzymes : Alanine aminotransferase : IRMM/IFCC 454 ;
Enzymes : Human Creatine Kinase CK-MB : IRMM/IFCC 454.
Other reference materials are presently under development such
as : HCG-Related Preparations ; HbA1c ; Myoglobin ; Troponin I
; L(p)a ; Soluble Transferrin Receptor in CRM 470 ; Factor V R:506Q
Leiden.
IFCC is presently actively implicated with other national and
international organizations and manufacturers in the establishment
of a Joint Committee for Traceability in Laboratory Medicine
(JCTLM) which would have as one of its tasks to establish Networks
of Reference Laboratories and seeking sponsorship to sustain these
networks. In brief, the main goal of this Joint Committee would
be :
� to achieve international equivalence in
laboratory medicine by development of international conventional
reference systems comprising reference materials, reference
measurement procedures, implementation of reference measurement
laboratories for selected and prioritized analytes in relation to
medical needs �.
The participant expert laboratories for quantification of
well-defined analytes will be competent in using the best
internationally recognized analytical procedures and their main
responsibility will be to assign values to reference materials
using the metrological approach to establish through a chain of
comparisons the traceability and uncertainties of routine methods.
IFCC has already established a number of Networks of Reference
Laboratories such as the Network on Reference Laboratories in
Clinical Enzymology or the Network of Reference Laboratories for
Standardization of HbA1c. More details about the
standardization activities of the IFCC can be found on the Website
of the IFCC : www.ifcc.org.
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