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41
| 2 | 2010
Klinisk Biokemi i Norden
(Fortsætter side 42)
• Facilitate the development and implementation
of diagnostic strategies.
• Establish standards for scientific and technical
aspects of good laboratory practice.
• Respond to scientific and technical needs of
IFCC Member Societies, IFCC Corporate Mem-
bers and external agencies.
• Participate actively in the scientific programs of
IFCC congresses and other scientific meetings.
• Ensure the quality of IFCC scientific documents.
• Organise Master Discussions.
The SD is composed of a Division Executive Com-
mittee, Committees, and Working Groups. The SD
Executive committee consists of up to six members,
including the Chair and the Vice-Chair, and additio-
nally one individual is nominated by the Corporate
Members of IFCC. The current Chair of SD is Pro-
fessor Mauro Panteghini from Italy. You will find the
minutes of the Executive Committee meetings on the
IFCC website under Scientific Activities (www.ifcc.
org). There is a lot of interesting information of the
important work of SD.
Committees usually consist of up to five members,
including the chair. In addition, committees have as
many Corresponding Members as are nominated by
their National Societies or Corporate Members. The
chairs are nominated by the Executive Committee of
the SD, and approved and appointed by the EB. The
term of office of each Committee member is three
years, with a possibility of extension for another three
year period.
The number of members in Working Groups
varies. Members may be appointed or dismissed
according to the terms of reference of the specific
WG. The chair is nominated by the WG members
and appointed by the Division Executive Committee.
At the moment SD has 6 Committees and 13 Wor-
king Groups. You will find the list of all these units on
the IFCC website as well as their composition, terms
of reference and lists of their current projects.
The standardization and the new unit of hemoglo-
bin A
1c
is presently the best known project of SD. It
is an excellent example of how to implement a new
standard and how to achieve this by cooperating with
the clinicians and the industry. The story of HbA
1c
began when SD Committee on Nomenclature, Pro-
perties and Units (C-NPU) first published the new
standard, name and unit for HbA
1c
. The development
of the IFCC reference system for HbA
1C
took many
years to achieve when the new nomenclature and the
suggested new units were introduced, clinicians from
all over the world expressed their wish not the change
then current system.
Following that outburst, IFCC organized meetings
with the associations and federations representing the
diabetes community (The American Diabetes Asso-
ciation ADA, European Association for the Study of
Diabetes EASD, and the International Diabetes Fede-
ration IDF). The clinicians worldwide expressed their
worry that the new reference method to standardize
the HbA
1C
results does indeed indicate average blood
glucose, and they proposed changes in the reporting
of A
1C
test results. To reach an agreement a meeting
was held in Milan, Italy, on 4 May 2007, and a con-
sensus statement was approved. It was agreed that
HbA
1C
test results should be standardized worldwide,
including the reference system and results reporting
and that the new IFCC reference system for HbA
1C
represents the only valid anchor to implement stan-
dardization of the measurement. HbA
1C
results are
to be reported worldwide in IFCC units (mmol/mol)
and derived NGSP units (%), using the IFCC-NGSP
master equation. At that point “average blood glucose
was included in the statement providing that the on-
going “average plasma glucose study” fulfills its a pri-
ori–specified criteria, an A
1C
-derived average glucose
(ADAG) value calculated from the A
1C
result will also
be reported as an interpretation of the A
1C
results.
IFCC organized a manufacturers’ meeting in
Milan, Italy, on December 12, 2007 and 14 major
companies in the field attended. The meeting agreed
that all manufacturers should implement worldwide
the traceability to the IFCC reference system for
HbA
1c
. In the European Union (EU) the implemen-
tation of calibration traceability in Laboratory Medi-
cine to higher-order standards is already mandatory.
The EU directive 98/79/EC on IVD medical devices
explicitly requires manufacturers to ensure and docu-
ment metrological traceability of their products. The
deadline for implementing traceability to the IFCC
reference system was December 31
st
, 2009 for all the
instruments in current use. From January 1
st
, 2011 all
the new instrumentation will report (as a result of an
HbA
1c
test) both IFCC and NGSP derived units, in
agreement with the Consensus Statement.
A second consensus meeting was held at the IDF
