Lecture
Implementation of Metrological Traceability for Small Molecules IVD Assays: An Industrial Perspective
- at -
- ICM Saal 4a
- Type: Lecture
Lecture description
Judith Taibon1, Neeraj Singh1, Elie Fux1
1 Roche Diagnostics GmbH, Penzberg, Germany
Standardization is fundamental to analytical measurement in laboratory medicine, ensuring the consistency of patient results across different laboratories and timeframes. However, achieving comparability remains a significant challenge due to the frequent
absence of primary reference materials (PRMs) and reference measurement procedures (RMPs) for many small molecule analytes. While National Metrology Institutes (NMIs) establish primary traceability chains, the vast number of clinically relevant parameters necessitates that in vitro diagnostic (IVD) manufacturers and academic institutions actively drive traceability initiatives. This presentation details a collaborative effort to bridge this gap for small molecules.
To support the standardization of clinical mass spectrometry and chemistry assays, Isotope Dilution Mass Spectrometry (ID-LC-MS/MS) based RMPs were developed and validated in adherence to ISO 15193. Traceability to SI units was established using
commercially available PRMs or, where unavailable, materials characterized internally via quantitative nuclear magnetic resonance (qNMR) in compliance with ISO 15194.
The primary objective of this workflow is the listing of RMPs with the Joint Committee for Traceability in Laboratory Medicine (JCTLM) following peer-reviewed publication and transparent protocol dissemination.
For numerous small molecule analytes, existing reference systems were either unavailable or unsuitable for the specific working ranges required by clinical assays. Therefore, an extensive portfolio of ID-LC-MS/MS-based reference measurement
procedures (RMPs) was developed to ensure traceability. These methods were used to assign target concentrations to a native sample curve panel and thereby standardize routine IVD assays. This initiative has currently resulted in over a dozen methods being listed in the JCTLM database, with an additional dozen currently under review for publication and listing.
This session will provide a technical overview of the progress made in establishing metrological traceability for small molecules. We will highlight the methodologies and validation processes employed and demonstrate how mass spectrometry-based RMPs
are practically applied for the target value assignment of calibrators and the ongoing assessment of routine assay performance
1 Roche Diagnostics GmbH, Penzberg, Germany
Standardization is fundamental to analytical measurement in laboratory medicine, ensuring the consistency of patient results across different laboratories and timeframes. However, achieving comparability remains a significant challenge due to the frequent
absence of primary reference materials (PRMs) and reference measurement procedures (RMPs) for many small molecule analytes. While National Metrology Institutes (NMIs) establish primary traceability chains, the vast number of clinically relevant parameters necessitates that in vitro diagnostic (IVD) manufacturers and academic institutions actively drive traceability initiatives. This presentation details a collaborative effort to bridge this gap for small molecules.
To support the standardization of clinical mass spectrometry and chemistry assays, Isotope Dilution Mass Spectrometry (ID-LC-MS/MS) based RMPs were developed and validated in adherence to ISO 15193. Traceability to SI units was established using
commercially available PRMs or, where unavailable, materials characterized internally via quantitative nuclear magnetic resonance (qNMR) in compliance with ISO 15194.
The primary objective of this workflow is the listing of RMPs with the Joint Committee for Traceability in Laboratory Medicine (JCTLM) following peer-reviewed publication and transparent protocol dissemination.
For numerous small molecule analytes, existing reference systems were either unavailable or unsuitable for the specific working ranges required by clinical assays. Therefore, an extensive portfolio of ID-LC-MS/MS-based reference measurement
procedures (RMPs) was developed to ensure traceability. These methods were used to assign target concentrations to a native sample curve panel and thereby standardize routine IVD assays. This initiative has currently resulted in over a dozen methods being listed in the JCTLM database, with an additional dozen currently under review for publication and listing.
This session will provide a technical overview of the progress made in establishing metrological traceability for small molecules. We will highlight the methodologies and validation processes employed and demonstrate how mass spectrometry-based RMPs
are practically applied for the target value assignment of calibrators and the ongoing assessment of routine assay performance
