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Standardization of Cystatin C: Development of Primary and Secondary Reference Preparations

Overview
Journal Scand J Clin Lab Invest Suppl
Specialty Pathology
Date 2008 Aug 21
PMID 18569968
Citations 35
Authors
S Blirup-Jensen
A Grubb
V Lindstrom
C Schmidt
H Althaus
Affiliations
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Abstract

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.

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