Improving the supply of clinical reference materials via collaborative efforts for
the coordination of reference measurements.
G. O’Connor, Braunschweig, DE
Physikalisch-Technische Bundesanstalt (PTB), Braunschweig, Germany and
Technische Universität Braunschweig, Braunschweig, Germany
National Measurement Institutes (NMIs) currently assure the traceability of their
measurement results for a small number of highest priority clinical measurands by
conduct comparison studies to demonstrate their equivalence and hence their
capabilities for providing traceable measurement results for supporting globally
comparable patient measurement results.
The procedures used by the NMIs in these comparisons are the same as those used to
characterise reference materials and to provide assigned values to proficiency testing
schemes. Whilst these procedures provide the best trueness and lowest measurement
uncertainty, they are highly labour intensive and time consuming and therefore the
number of such studies are limited. To address this issue the Organic Analysis Working
Group (OAWG) of the Consultative Committee for Amount of Substance: Metrology in
Chemistry and Biology (CCQM) co-ordinates studies that enable NMIs to back broader
claims by looking at specific measurands that challenge particular analytical skills and
that can be reasonably assumed to represent a wider group of measurands as agreed
by the technical experts within the working group. This provides a mechanism for
assuring the equivalence of measurement results provided by NMIs when assigning
values to certified reference materials (CRMs).
The number of measurands being prioritised by clinical laboratory experts is increase,
as to is their complexity and the challenges of dealing with lower concentrations.
Therefore, it is not possible for a single NMI to cover the wide range of materials or
reference measurement being requested. To address these issues NMIs are starting to
coordinate their activities. An example of this is the newly formed European Metrology
Network for Traceability in Laboratory Medicine, where NMIs are working together to
ensure a broader scope of activities and limited the duplication of effort between NMIs.
In order to fully achieve their aims, NMIs must work closely and collaboratively with
clinical lab medicine experts, invitro diagnostic providers and legislators to ensure that
measurands are appropriately prioritised and that reference measurement procedures
and commutable RMs are available to assure the comparability of real patient
measurement results.