Standardization of Cystatin C:: Development of primary and secondary reference preparations

被引：66

作者：

Blirup-Jensen, S. ^{[1
]}

Grubb, A. ^{[1
]}

Lindstroem, V. ^{[1
]}

Schmidt, C. ^{[2
,3
]}

Althaus, H. ^{[4
]}

机构：

[1] Univ Lund Hosp, Dept Clin Chem, S-22185 Lund, Sweden

[2] Dako AS, Global Clin Immunochem, Glostrup, Denmark

[3] Dako AS, OEM, Glostrup, Denmark

[4] Dade Behring Marburg GmbH, Marburg, Germany

来源：

SCANDINAVIAN JOURNAL OF CLINICAL & LABORATORY INVESTIGATION | 2008年 / 68卷

关键词：

Cystatin C; dry mass determination; Primary Reference Preparation; Secondary Reference Preparation; standardization of Cystatin C;

D O I：

10.1080/00365510802150067

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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.

引用

页码：67 / 70

页数：4

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