First certified reference material for cystatin C in human serum ERM-DA471/IFCC

First certified reference material for cystatin C in human serum ERM-DA471/IFCC
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DOI:
10.1515/cclm.2010.318
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发表时间:
2010-11-01
影响因子:
6.8
通讯作者:
Zegers, Ingrid
Zegers, Ingrid
中科院分区:
医学2区
文献类型:
--
作者:
Grubb, Anders;Blirup-Jensen, Soren;Zegers, Ingrid

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IFCC胱抑素C标准化工作组(WG-SCC)与标准物质和测量研究所(IRMM)合作,宣布提供新的认证标准物质ERM-DA 471/IFCC。使用纯蛋白质一级参比制剂(PRP)作为校准品对材料进行表征。从重组半胱氨酸蛋白酶抑制剂C制备PRP,并使用干质量测定法测量其浓度。通过颗粒增强免疫比浊法、颗粒增强免疫比浊法和酶放大单向免疫扩散进行ERM-DA 471/IFCC的表征。如果按照规定程序复溶,则ERM-DA 471/IFCC中经认证的胱抑素C质量浓度为5.48 mg/L,扩展不确定度(k=2)为0.15 mg/L。临床化学实验室医学2010;48:1619-21。
The IFCC Working Group for the 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 measured using 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) being 0.15 mg/L. Clin Chem Lab Med 2010;48:1619-21.