Health diagnostics: two JRC certified reference materials listed as higher-order reference materials by the Joint Committee for Traceability in Laboratory Medicine.
Two certified reference materials (CRM) for healthcare measurements, one containing a sensitive marker for inflammation and tissue damage (CRM ERM-DA474/IFCC) and the other to support the diagnosis of kidney damage (CRM ERM-DA471/IFCC), have been produced according to ISO Guide 34 and were released in October 2011 and May 2010, respectively.
In February 2013, 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-DA474/IFCC is a human serum material containing a defined mass concentration of C-reactive protein (CRP). CRP is a very sensitive marker of inflammation and tissue damage and the routine clinical uses include the diagnosis of bacterial and viral infections as well as the assessment of disease activity in inflammatory conditions like rheumatoid arthritis.
CRM ERM-DA471/IFCC is another human serum material with a defined mass concentration of the protein Cystatin C. In clinical chemistry Cystatin C is an important analyte determined in plasma or serum samples of patients, used to diagnose kidney damage by establishing the glomerular filtration rate (GFR). ERM-DA471/IFCC is used for the calibration of these clinical measurement methods.
European Directive 98/79/EC on In vitro Diagnostic Medical Devices (IVDMD) 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.