Metrological Traceability for IVD Standardisation Needs Rigorous Implementation, Not Just Formal Claims
Despite broad agreement that IVD measurements should be traceable to higher-order references, a non-negligible number of measurands still lack proper implementation, posing patient safety risks from non-harmonised results. This review calls on reference material providers, manufacturers, and EQA organisers to rigorously apply ISO 17511:2020 and JCTLM standards, while urging laboratories to abandon non-selective methods in favour of IVD-MDs with proper analytical selectivity.
The original study
An improved implementation of metrological traceability concepts is needed to benefit from standardization of laboratory results.
- Authors
- Panteghini M
- Journal
- Clinical chemistry and laboratory medicine
- Type
- Journal Article, Review
- PMID
- 38687497
Original abstract
Non-harmonization of laboratory results represents a concrete risk for patient safety. To avoid harms, it is agreed that measurements by in vitro diagnostic medical devices (IVD-MD) on clinical samples should be traceable to higher-order references and adjusted to give the same result. However, metrological traceability is not a formal claim and has to be correctly implemented, which in practice does not happen for a non-negligible number of measurands. Stakeholders, such as higher-order reference providers, IVD manufacturers, and External Quality Assessment organizers, have major responsibilities and should improve their contribution by unambiguously and rigorously applying what is described in the International Organization for Standardization 17511:2020 standard and other documents provided by the international scientific bodies, such as Joint Committee on Traceability in Laboratory Medicine and IFCC. For their part, laboratory professionals should take responsibility to abandon non-selective methods and move to IVD-MDs displaying proper selectivity, which is one of the indispensable prerequisites for the correct implementation of metrological traceability. The practicality of metrological traceability concepts is not impossible but relevant education and appropriate training of all involved stakeholders are essential to obtain the expected benefits in terms of standardization.