Editorial from Graham Beastall, IFCC President
Method Standardization and Harmonization
For several years IFCC,
through its Scientific Division, has been a global leader in method
standardization. Several projects have resulted in the production
of reference materials, reference measurement procedures and
international reference laboratories. Working with the diagnostics
industry it has become possible to demonstrate traceability and
commutability between these reference standards and the results
obtained in service laboratories using commercial products. Method
standardization has been achieved for a growing number of the most
commonly performed analytes in clinical chemistry. A list of
standardized methods is available from the website of the Joint
Committee for Traceability in Laboratory Medicine (JCTLM), which is
strongly supported by IFCC (www.bipm.org/jctlm).
This programme of method standardization will continue to be
supported by IFCC. In addition, however, there is a growing
realization that patient safety is being compromised by
method dependent differences for many clinically important
biomarkers. This is especially true in the developing areas of
microbiology and molecular diagnostics. In many cases it is
not currently possible to meet the exacting requirements of method
standardization.
Consequently, a project has commenced under the leadership of
the American Association of Clinical Chemistry (AACC). This project
aims to reduce between method variability through harmonization
rather than full standardization. A summary of the project and an
explanation of the differences between standardization and
harmonization have recently been published: Millar WG, Myers GL,
Gantzer MLet al. Roadmap for harmonization of clinical chemistry
laboratory measurement procedures.Clin Chem2011; 58: 1108-1117
IFCC supports the harmonization project and is working with AACC
and other international stakeholders to introduce a co-ordinated
system that enable an increased number of important biomarkers to
be considered for method standardization or harmonization. This is
truly a project of global importance.
Further updates will be available through future issues of IFCC
News. In the mean time if you have comments or suggestions then
please direct them to Graham Beastall (gbeastall@googlemail.com
)