Establishing metrological traceability for small molecule measurands in laboratory medicine.

ABSTRACT

For molecules that can be well described metrologically in the sense of the definition of measurands, and which can also be recorded analytically as individual substances, reference measurement service traceability to a metrologically sound foundation is a necessity. The establishment of traceability chains must be initiated by National Metrology Institutes (NMIs) according to applicable standards; they are at the top and leading position in this concept. If NMIs are not in the position to take up this task, alternative approaches must be sought. Traceability initiatives established by in vitro device industry or academia must meet the quality standards of NMIs. Adherence to International Organization for Standardization (ISO) procedure 15193 must be a matter of course for the establishment of reference measurement procedures (RMPs). Certified reference material (CRM) characterization must be thorough, e.g., by the application of quantitative nuclear magnetic resonance measurements and by adherence to ISO 15194. Both for RMPs and CRMs Joint Committee for Traceability in Laboratory Medicine (JCTLM) listing must be the ultimate goal. Results must be shared in a transparent manner to allow other stakeholders including NMIs to reproduce and disseminate the reference measurement procedures.