LGC Standards offers new IRMM reference material for C-reactive protein
16 Nov 2011
Updated reference material for C-reactive protein available from LGC Standards
LGC Standards, Europe’s leading supplier of reference materials, has expanded its range of clinical reference standards from the Institute for Reference Materials and Measurements (IRMM), to include an updated material for C-reactive protein (CRP).
CRP is a very sensitive marker of inflammation and tissue damage, making it one of the most important analytes in clinical chemistry. Results of CRP analysis are routinely used in the diagnosis of bacterial and viral infections, the assessment of disease activity in inflammatory conditions such as rheumatoid arthritis and the determination of the long-term risk of cardiovascular disease and heart attacks.
IRMM has released a new reference material certified for CRP (ERM-DA474/IFCC) as the successor to reference materials ERM-DA472/IFCC and ERM-DA470, which have been almost entirely sold out following intense worldwide demand. Characterised using the reference material ERM-DA470 as a calibrant, the new material will ensure continuity in the standardisation of CRP, making it possible for laboratories worldwide to compare results over time and between hospitals and countries.
The new reference material ERM-DA474/IFCC is intended to be used to assign values to calibrators that are an integral part of in vitro diagnostic medical devices (IVD). The EU Directive on In Vitro Diagnostic Medical Devices (IVD-MD) (Directive 98/79/EC) requires traceability of calibrants and control materials to reference measurement procedures and/or reference materials of higher order. The International Federation of Clinical Chemistry (IFCC), which actively supports standardisation in clinical chemistry, has collaborated with IRMM on the development of ERM-DA474/IFCC.
Intensive research during production has led to an improved formulation of the material (e.g. liquid frozen instead of lyophilised and the addition of calcium chloride), to ensure that the CRP displays the same characteristics as the protein in fresh patient samples. The preparation of the material and its characterisation are described in a comprehensive certification report, which is available together with the certificate.
For further information on this new C-reactive protein reference material, or to place an order please visit the LGC webshop (www.lgcstandards.com), contact your local LGC Standards sales office, or email:email@example.com.