In February 2017 two JRC certified reference materials have been listed as higher-order reference materials in the database of the Joint Committee for Traceability in Laboratory Medicine.
Two certified reference materials (CRM) for healthcare measurements, one with an additional certified concentration for the cancer marker beta 2-microglobulin (ERM-DA470k/IFCC) and the other for a marker for the autoimmune disease vasculitis (ERM-DA476/IFCC) have been produced according to ISO Guide 34 and were both released in April 2015.
In February 2017, after an additional international review and approval process, both CRMs have been listed as higher-order reference materials by the Joint Committee for Traceability in Laboratory Medicine (JCTLM) in the corresponding global database (http://www.bipm.org/jctlm).
CRM ERM-DA470k/IFCC is a human serum material certified for the mass concentration of 13 proteins. For 12 proteins (amongst which important analytes like albumin, IgG, IgM, and transferrin) the certified values were released in 2008. In 2015 the material was additionally certified for the concentration of beta 2-microglobulin (B2M). B2M is used for the staging of multiple myeloma, and important for the prognosis and treatment of the cancer.
CRM ERM-DA476/IFCC is another human serum material which has been developed in collaboration with the International Federation for Clinical Chemistry and Laboratory Medicine (IFCC) Working Group for the Harmonisation of Autoimmune Tests. It is certified for the concentration of IgG antibodies against myeloperoxidase (IgG MPO ANCA). These antibodies represent the cornerstones of the diagnosis and monitoring of small vessel-associated vasculitis, together with IgG PR3 ANCA.
European Directive 98/79/EC on In vitro Diagnostic Medical Devices lays down that, if available, in-vitro diagnostics manufacturers need to use higher order reference material for the calibration of their in-vitro diagnostics assays. A higher order reference material fulfils beside the general requirements for CRMs also the specific ones related to clinical traceability as laid down in the standard ISO 15194:2009.
- 31 Marts 2017