Community Research and Development Information Service - CORDIS

FP7

Certification of C-reactive protein in reference material, ERM-DA472/IFCC, Certified Reference Material ERM-DA472/IFCC

Funded under: FP7-JRC

Abstract

The production and certification of ERM-DA472/IFCC, a new reference material certified for C-reactive protein (CRP), is described.
Serum was produced from blood collected in 6 blood collection centres according to a procedure ensuring that it was obtained from healthy donors, and that the lipid content of the serum was low.
The serum was processed in 5 batches, and then pooled, spiked with beta 2 microglobulin (B2M) and CRP and filled into ampoules (approximately 1 mL serum per ampoule). The serum was stored at -70 C. It was verified that the material was homogenous and stable. ERM-DA472/IFCC was characterised using the reference material ERM-DA470 as calibrant. This was achieved using a value transfer protocol that can be considered as a reference procedure. The principles used to measure the CRP concentration were immunonephelometry and immunoturbidimetry. The measurements were performed with different platform/reagent combinations (Abbott Architect, Beckman Immage, BN II, different Hitachi instruments, and Olympus AU640). In total 8 laboratories participated in the value assignment. The certified CRP mass concentration is 41.8 mg/L, the expanded uncertainty (k = 2) 2.5 mg/L.

Additional information

Authors: LINSINGER T, European Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Geel (BE);BIRGERSSON-LIEBICH A, European Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Geel (BE);PELLIZZATO F, European Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Geel (BE);VENELINOV T, European Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Geel (BE);VOORSPOELS S, European Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Geel (BE);LAMBERTY A, European Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Geel (BE)
Bibliographic Reference: EUR 23756 EN (2009), 28 pp. Free of charge
Availability: Available from European Commission, JRC Knowledge Management Unit, Ispra (IT) Tel: +39 033278 9893 Fax: +39 033278 5409 E-mail: jrc-info@ec.europa.eu or Bruxelles (BE) Tel: +32 2 295 76 24 Fax: +32 2 299 63 22
ISBN: ISBN: 978-92-79-11326-0
Record Number: 200910180 / Last updated on: 2009-02-26
Category: PUBLICATION
Original language: en
Available languages: en