The biennial Joint Committee for Traceability in Laboratory Medicine (JCTLM) Members and Stakeholders meeting was held at the BIPM, on 30 November and 1 December 2015. A total of 35 presentations covered sessions on: Developments in Traceability requirements in in vitro diagnostics around the Globe; Future priorities in Traceability in Laboratory Medicine; New Challenges for Traceability in Laboratory Medicine; and JCTLM Committee and Members Activities.
- Session I: Update on JCTLM Activities:
This update from the Executive Committee presented a revised structure and governance for the JCTLM; reviewed the current status and operation of the JCTLM Database and announced the creation of a Working Group for Traceability, Education and Promotion. A lively discussion followed with Members supportive of the developments.
- Session II: JCTLM Member Activities:
This session comprised presentations from nine JCTLM Members from seven different countries. An impressive range and quality of activities was reported. Several reference materials and measurement procedures are produced by these Members in response to requests from clinicians, users of laboratory services and companies. Some of the presentations referred to External Quality Assurance (EQA) schemes based on traceable materials. It was gratifying to see the commitment to education and innovation in support of improved traceability and standardization in laboratory medicine.
- Session III: Developments in Traceability Requirements around the Globe:
Two presentations addressed the status of traceability in laboratory medicine in China and Latin America, respectively. The role of the WHO Expert Committee for Biological Standardization was presented together with plans for new International Standards and reference reagents. Finally, a presentation was given of the work on method harmonization protocols that is taking place as part of the revision of ISO 17511.
- Session IV: Identifying Future Priorities in Traceability in Laboratory Medicine:
Two presentations addressed the opportunities that exist for the production of further reference materials and methods. A gap analysis looked at the assays for commonly performed analytes that do not have entries in the JCTLM Database whilst the need for other developments was highlighted by examining assays that perform poorly in EQA schemes. The evolving International Consortium for the Harmonization of Clinical Laboratory Results and the expanding RELA External Quality Assessment Scheme for Calibration Laboratories also pointed towards future priorities.
- Session V: New Challenges for Traceability in Laboratory Medicine:
The session with the most speakers (14) addressed areas of laboratory medicine where there are challenges in introducing or delivering traceability.
- Three presentations reviewed the current situation in haematology and coagulation, including two different approaches to reference methods for blood cell counting.
- Four presentations addressed the need for and approach to producing reference materials and methods for nucleic acid testing in infectious disease and cancer diagnostics.
- The importance of traceable methods in clinical practice was examined based on long-established lipid methods and an alternative approach to cardiovascular risk assessment was proposed based on counting lipoprotein particles rather than measuring lipid content.
- The production of the first traceable reference material in autoantibody testing was reported, as was the glyco-engineering approach to producing a possible reference preparation of TSH.
- Two presentations highlighted that after reference materials and methods have been produced, there will still be challenges of implementation.
- Finally, the topic of commutability of reference materials was clarified with logical protocols and commutability criteria.
The 2015 JCTLM Members and Stakeholders meeting was a stimulating experience for all participants. It indicated that there is increasing recognition of the importance of reference materials and reference methods as anchors for quality assays in laboratory medicine. Individual presentations can be downloaded from the JCTLM webpages.
The next meeting to be held under the auspices of the JCTLM will take place on 1 to 3 June 2016, in Chengdu, Sichuan Province, China, with a focus on 'Protein and Peptide Diagnostics and Therapeutics: Research and Quality Assurance'. Interest in participation in the workshop and requests for further information can be registered by sending an email to jctlm(a)bipm.org.
|Relative enumeration of lyophilised CD4+ cells, taken from the presentation of J. Neukammer (PTB) on 'Metrological traceability in cell concentration determination'.
|Lipoprotein size vs. density taken from the presentation of V. Delatour (LNE) on 'Traceable lipoprotein counting for Cardiovascular disease risk assessment'.