欧洲标准局IRMM JRC 参考物质 可追溯性证明文件 ERM-DA474_IFCC Traceability.pdf

EUROPEAN COMMISSION DIRECTORATE-GENERAL JOINT RESEARCH CENTRE Directorate F - Health, Consumers & Reference Materials (Geel/Ispra) Reference Materials Unit Geel, 8 May 2018 Subject: Traceability of the certified values of ERM-DA474/IFCC To whom it may concern: The certified value for c-reactive protein (CRP) of ERM-DA474/IFCC was assigned by immunonephelometry and immunoturbidimetry using ERM-DA470 as calibrant. ERM-DA470 is physically the same material as BCR-470 [1], but was re-branded under the ® ERM brand in 2004. The certified value for CRM of BCR-470/ERM-DA470 is traceable to the first international standard for CRM, i.e. CRP 85/506 [2]. This means that the certified value of ERM-DA474/IFCC is traceable to the WHO international standard 85/506 via calibration with ERM-DA470. Dr Thomas Linsinger Responsible RM Distribution 1 S. Baudner et al, The certification of a matrix reference material for Immunochemical measurement of 15 Serum Proteins , EUR Report 15243 EN, Luxembourg: Office for Official Publications of the European Communities, 1993; https://publications.europa.eu/en/publication-detail/-/publication/ee6a9d91-8db6-4510-a465- 230294075591 ; accessed 8.5.2018 2 WHO international standard. Human C-reactive protein 1st international standard. NIBSC code: 85/506. /documents/ifu/85-506.pdf; accessed 8.5.2018 Retieseweg 111, B-2440 Geel - Belgium. Telephone: direct line (32-14) 571-956. Fax: (32-14) 571-548. E-mail: thomas.linsinger@ec.europa.eu