Certification of Cystatin C in the Human Serum Reference Material ERM-DA471/IFCC - Certified Reference Material ERM®-DA471/IFCC

The production of ERM-DA471/IFCC, certified for the mass concentration of cystatin C, is described. Serum was produced from blood collected in 2 collection centres according to a procedure ensuring that it was obtained from healthy donors, and that the lipid content of the serum was low. The serum was processed, spiked with recombinant cystatin C, and lyophilised. It was verified that the material is homogenous and stable. The material was characterised using a pure protein primary reference preparation (PRP) as calibrant. The PRP was prepared from recombinant cystatin C, and its concentration determined by dry mass determination. The characterisation of ERM-DA471/IFCC was performed by particle enhanced immuno-nephelometry, particle enhanced immuno-turbidimetry and enzyme amplified single radial immuno-diffusion. The certified cystatin C mass concentration in ERM-DA471/IFCC, if reconstituted according to the specified procedure, is 5.48 mg/L, the expanded uncertainty (k = 2) is 0.15 mg/L.JRC.DG.D.2-Reference material

First Certified Reference Material for Cystatin C in Human Serum ERM-DA471/IFCC

The IFCC Working Group for standardisation of Cystatin C (WG-SCC) in collaboration with the Institute for Reference Materials and Measurements (IRMM) announces the availability of the new certified reference material ERM-DA471/IFCC. The material was characterised using a pure protein primary reference preparation (PRP) as calibrant. The PRP was prepared from recombinant cystatin C and its concentration determined by dry mass determination. The characterisation of ERM-DA471/IFCC was performed by particle enhanced immune-nephelometry, particle enhanced immuno-turbidimetry, and enzyme amplified single radial ummuno-diffusion. The certified cystatin C mass concentration in ERM-DA471/IFCC is 5.48 mg/L, the expanded uncertainty (k= 2) being 0.15 mg/LJRC.D.2-Reference material

Preliminary Commutability Study on Candidate Reference Material for Cystatin C

Plasma (or serum) cystatin C has been proposed as a marker for the glomerular filtration rate, a measure of the capacity of the kidneys to filter plasma (GFR). Several studies, as well as one meta-analysis, have suggested that it is superior to serum creatinine for estimation of GFR. The IFCC working group for the standardisation of cystatin C has, in collaboration with the IRMM, prepared a candidate reference material (RM) for cystatin C. here the results from a preliminary study, performed in order to optimise the design of a planned large-scale commutability study, are presented.JRC.D.2-Reference material