Standardization of Cystatin C: development of primary and secondary reference preparations.

Summary, in English

A Primary Reference Preparation has been produced using pure, recombinant, Cystatin C in a solvent of 0.1 mol/L KCl. Dry mass determination of the Primary Reference Preparation resulted in a Cystatin C concentration of 5.20 g/L. Agarose-electrophoresis and SDS-electrophoresis, as well as N-terminal sequencing, verified the purity, homogeneity and identity of Cystatin C in the Primary Reference Preparation. For the Secondary Reference Preparation, a serum pool was collected and stabilized. A pilot batch was made to verify the selected procedure and spiking with the pure, recombinant Cystatin C. The final Secondary Reference Preparation is now produced (4468 vials) and ready for value assignment and further characterization.

• Author: Soren Blirup; Anders Grubb; Veronica Lindström; C Schmidt; H Althaus
• Department/s: Division of Clinical Chemistry and Pharmacology
• Publishing year: 2008
• Language: English
• Pages: 67-70
• Publication/Series: Scandinavian Journal of Clinical & Laboratory Investigation
• Volume: 68
• Issue: s241
• Links: http://www.ncbi.nlm.nih.gov/pubmed/18569968?dopt=Abstract; http://dx.doi.org/10.1080/00365510802150067
• Document type: Journal article
• Publisher: Informa Healthcare
• Topic: Medicinal Chemistry; Pharmacology and Toxicology
• Keywords: Primary Reference Preparation; Secondary Reference Preparation; standardization of Cystatin C; dry mass determination; Cystatin C
• Status: Published
• ISBN/ISSN/Other: ISSN: 1502-7686