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C-reactive protein (CRP) is one of the most important analytes in clinical chemistry. It is a very sensitive marker of inflammation and tissue damage. Routine clinical uses of CRP results include the diagnosis of bacterial and viral infections, the assessment of disease activity in inflammatory conditions like rheumatoid arthritis, and the determination of the long-term risk of cardiovascular disease and heart attacks. 
 
The Institute for Reference Materials and Measurements (IRMM) has released a new reference material certified for CRP. The reference material, ERM-DA474/IFCC, is the successor of ERM-DA472/IFCC and ERM-DA470, which were until recently used worldwide as the standard for CRP. These materials were on such a high demand that the production of a replacement was required. The new material will ensure continuity in the standardisation of CRP, which is crucial in clinical chemistry. It makes it possible for laboratories worldwide to use common reference ranges, and to compare results over time and between hospitals and countries.

The 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.

The ERM-DA474/IFCC was produced from serum from blood collected in 4 blood collection centres according to a well-controlled procedure ensuring that it was obtained from healthy donors and that ERM-DA474/IFCC is most suited for the IVD devices currently available. The material was characterized using the reference material ERM-DA470 as a calibrant. For the production ERM-DA474/IFCC intensive research has been carried out on all stages of its development, from the effect of the processing on the physicochemical characteristics of the proteins to the validity of the metrological traceability chain and the commutability of the final material. These efforts have led to a different and optimised formulation of the material (e.g., liquid frozen instead of lyophilised, addition of calcium chloride), ensuring that the CRP is behaving like the protein in fresh patient samples.

The preparation of the material and its characterization are described in a comprehensive certification report, which is available together with the certificate.

JRC-IRMM has released two new reference materials which will enable food-testing laboratories to reliably detect and quantify oxytetracycline in milk.

Oxytetracycline is a broad-spectrum antibiotic and highly effective against many pathogenic bacteria and widely used in lactating and non-lactating dairy cattle for treatment of bacterial infections such as enteritis, pneumonia, and diphtheria. However, to protect consumers from possible adverse side effects, a maximum residue limit (MRL) of 100 μg OTC/kg milk has been stipulated in EU legislation (Commission Regulation No. 508/1999).

A set of two certified reference material is now available: oxytetracycline in partially skimmed milk (ERM-BB492) and partially skimmed milk blank material (ERM-BB493). Spray-dried milk powder was chosen for the matrix format, as it best meets the stability requirements while assuring good reconstituteability.

The reference materials are intended to be used for method validation purposes (trueness estimation) and method performance control. The certified value for ERM-BB492 is 101 ± 11 μg/kg (mean ± expanded uncertainty, k=2) and is based on an inter-laboratory characterisation study; the uncertainty value contains contributions from the characterisation study, the common calibrant, and the homogeneity and stability assessment. For ERM-BB493, the certified value was established as "< 5 µg/kg" and corresponds to the LOQ of the most sensitive method in the intercomparison. Both values are traceable to the International System of Units (SI). The material has been processed and certified in accordance to ISO Guides 34 and 35. Details about material processing and certification are described in detail in the certification report.

A new scientific facility to develop measurement standards in challenging areas such as life sciences was inaugurated on 23 November 2010 at the European Commission's Joint Research Centre in Geel, Belgium. The Flemish Minister-President, Kris Peeters, and the European Commission's Director-General for Enterprise and Industry, Heinz Zourek, performed the ribbon-cutting.

(Watch the video of the inauguration ceremony)

The European Commissioner for Research, Innovation and Science, Máire Geoghegan-Quinn, said: "From buying food in the supermarket to undergoing clinical tests, European citizens depend on measurements and testing to be as accurate and harmonised as possible. This is particularly important for emerging technologies, such as genetic testing and nanotechnology. This new facility will enable the European Commission's Joint Research Centre (JRC) to remain at the forefront of measurement science, by developing internationally-recognised measurement standards that are used as benchmarks in analytical laboratories across Europe and worldwide."

The new facility will be used to develop and produce reference materials, which possess a precisely-known property and are the basis for complex measurements, such as the amount of genetically modified maize or the number of bacteria in a food sample. The total cost of the facility was 11 M€ – of which 4.5 M€ was funded from revenue from JRC's reference material activities.

The reference materials developed and produced at JRC's Institute for Reference Materials and Measurements (IRMM) provide laboratories around the world with a benchmark to deliver accurate, harmonised and traceable result and help implement legislation through accurate and reliable testing, also in emerging areas such as molecular biosciences and personalised medicine.

The building features a large and flexible production hall which brings together processing and measurement equipment in an innovative manner. It will provide Europe with a unique facility for the development and production of reference materials, bridging the gap between laboratory and industrial scale. The new building also houses laboratories for the analysis of heavy metals and proteins and a special laboratory for the safe handling of biomaterials.

(Download the press release: English, Deutsch, français.)

About reference materials

There are countless examples in which accurate measurements are crucial, such as hospital blood tests, measuring the size of nanoparticles or checking shipments of foodstuffs for the presence of genetically modified organisms, and they all have a direct impact on the citizens' every day life.

Reference materials play a crucial role behind the scenes, enabling analytical laboratories over the world to carry out tests in a comparable and harmonised manner. They are used by laboratories to calibrate their instruments, to develop reliable testing methods and to perform their regular quality controls.

The JRC's Institute for Reference Materials and Measurements (IRMM) is one of the leading developers and producers of reference materials in the world, particularly in the clinical, food and GMO application areas. It currently provides over 670 reference materials, and distributes around 20,000 units per year.

Some examples of JRC-IRMM’s reference materials:

• JRC-IRMM produced the world’s first ever certified reference materials for GMO quantification in food and feed in 1999, and is today recognised as a world leader in the area of GMO reference materials in food and feed.

• Measurements of serum proteins are used for the diagnosis of many conditions including infection, liver or kidney disorders and the monitoring of autoimmune diseases. The JRC-IRMM's reference materials for human serum proteins are since the 1990s the de facto standards which enable laboratories worldwide to use common reference ranges in diagnosis and to compare results between hospitals and countries over time. More recently, replacement reference materials for 12 proteins were released in 2008, and a separate one for the important C-reactive protein in 2009 – which is unique in the world.

• In 2009, three reference materials produced by JRC-IRMM for genetic testing became the first ever reference materials to be accepted internationally in the area of genetic testing by the Joint Committee for Traceability in Laboratory Medicine (JCTLM). These reference materials are suitable for the quality control of the identification of a human genetic mutation.

• JRC-IRMM produces in addition highly specialised reference materials to check and account for irradiated nuclear fuel in nuclear safeguards applications.

The JRC Institute for Reference Materials (IRMM)

The mission of the IRMM is to promote a common and reliable European measurement system in support of EU policies. The prime objective of the IRMM is to build confidence in the comparability of measurements by the production and dissemination of internationally accepted quality assurance tools, including validated methods, reference materials, reference measurements, interlaboratory comparisons and training.

The JRC-IRMM's new building for reference material production was officially inaugurated by the Flemish Minister-President, Kris Peeters (right), and the European Commission's Director-General for Enterprise and Industry, Heinz Zourek (left), with the Director of JRC-IRMM, Krzysztof Maruszewski (centre) presiding.

The Director of JRC-IRMM, Krzysztof Maruszewski, addresses the guests during the opening ceremony. The inauguration of the new building for reference material production also marked the opening of a three-day international conference entitled "The Future of Reference Materials - Science and Innovation", held under the auspices of the Belgian Presidency of the EU.

Flemish Minister-President, Kris Peeters, inspects some processed pistachio nuts during a tour of the production hall.

JRC-IRMM would like to inform our internet visitors that we have recently changed the underlying software used to host the internet site.

In general, the website has retained the same look and feel. However, the new software means that the URL addresses of all the pages have changed, and this may result in out-of-date bookmarks. Please also note that the Community Reference Laboratories pages are now located in the section "European Union Reference Laboratories".

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The symposium aims at mapping out the current and upcoming measurement and testing needs for which challenging demands on reference materials are envisaged. Forward-looking contributions are invited on the scientific and technological demands and developments for the design, preparation and certification of such measurement standards. For more information, click here.

JRC-IRMM has released Application Note 6 on the correct use of ERM certificates and materials. The note describes some practical aspects associated with handling and use of certified reference materials (CRMs) in laboratories, and is now also available in all EU languages, as well as in Chinese and Japanese. The various values provided on a certificate, re-use of materials, applying a moisture correction and interpretation of the traceability statement are also explained.

JRC-IRMM User support - ERM Application Notes