Objective
Specific Objectives
- To provide a vital link for building a common reference system in the clinical chemistry sector not only within the European Research Area but also rather on an international level.
- To provide clinical CRMs to users world-wide as required to support international health care and in co-operation with the IFCC;
- CRMs for alpha amylase, first steps towards a calibration panel of glycated haemoglobin and the certification of RMs, such as cardiac markers (myoglobin), serum reference solutions and reference materials for genetic markers.
Planned Deliverables
Specific Deliverables to DGs
- Production and short term stability of a Hb1Ac reference material;
- Production and homogeneity study of a myoglobin reference material;
- Completion of homogeneity and short term stability study of progestorone and total protein CRM;
- Setting up the JCTLM committee under the auspices of BIPM to achieve a common reference system in the clinical sector.
Deliverables as a result of the research
- Finalisation of the commutability study on amylase;
- Publication of 4 international reference procedures for enzyme activity measurements;
- Progress report of the CRMGEN project (production of human DNA CRMs).
Summary of deliverables made by: 31/12/2001
Certification ASAT DG RTD/IFCC
The certification of ASAT reference material at 37°c instead of 30°c is now mandatory because most routine measurements of catalytic activity are carried out at this, the normal body temperature.
ASAHI developed a recombinant material and has freeze dried a trial batch offering significant advantages compared to a liquid frozen material. If proven to be commutable and since ASAHI can only produce the material in screw cap vials IRMM will produce the material in ampoules and is awaiting information regarding the commutability study. The reference procedure has been submitted to the IFCC committee for ballot and invitations to tender for the homogeneity study and the stability studies have been sent to the European participants.
Certification alpha amylase Directive 98/79/EC (IVDMD) DG RTD/IFCC
The certification of alpha amylase at 37°C instead of 30°C is now mandatory because most routine measurements of enzyme catalytic activity are carried out this, the normal body temperature.
The technical meeting for the discussion of characterisation measurements took place in March. As the quality of the results is good so certification was deemed possible. The certification report was drafted and finalised and send for printing. A commutability study was planned in agreement with the University for Medicine Hannover, Germany.
Calibration panel glycated haemoglobine Directive 98/79/EC (IVDMD) DG RTD/IFCC
This potential reference material will become one of the most important parameters to measure the glucose concentration in patient's blood and will, as such, improve the diagnosis of diabetes.
A batch of several hundred mg of purified Hb1Ac and HbA0 materials (including protocols for production and characterisation) have been offered to IRMM by Roche to become IRMM/IFCC reference materials. The worldwide network of reference laboratories will need these materials. The commutability and feasibility study for matrix reference materials was completed by the working group.
Price and quantity of the individual HbA1c and HbA0 batches was negotiated with Roche and the purchase procedure of the material was initiated.
Myoglobin as a Cardiac Marker Directive 98/79/EC (IVDMD) DG RTD/IFCC
Myoglobin is one of the proteins which is released in high amount in blood circulation during heart infarction. The standardisation of its measurement is therefore useful for a more precise diagnosis of heart infarction. The commutability study was finalised and IRMM carried out the statistical analysis and was requested to propose the most suitable candidates. The working group for cardiac markers as performed by IRMM unanimously accepted the primary evaluation and it was decided to base the final certified value on the preparation rather than on the measurements. The producer of the selected material (HyTest Ltd.) will now be contacted to discuss the modalities of the production of a second batch and quality control material still available from the original batch.
Progesterone in human serum high level Directive 98/79/EC (IVDMD) DG RTD/IFCC
Measurement of progesterone in blood is performed for the evaluation of ovulation.
After lengthy investigation a supplier of suitable sera was found, the material ordered and delivered to NIBSC. There the material is presently being ampouled and lyophilised.
Total protein in human serum Directive 98/79/EC (IVDMD) DG RTD/IFCC
The total serum proteins level can be characteristic of specific diseases.
The discussion on value assignment protocol (type of method and calibrants) continued in close co-operation with the IFCC committee on serum proteins and IRC was contracted regarding the price of the calibrator. The design of the homogeneity, stability and characterisation studies were decided upon.
Definition of future projects
- A proposal on thyroid function tests (free T4 (thyroxin), total T3 (triiodothyronin) and T4, TSH) was accepted for funding by M&T. The contract negotiations are presently ongoing;
- A proposal for Factor V Leiden genetic disorder accepted and the contract negotiations are ongoing;
- Agreement was obtained with the IFCC committee on molecular biology to produce and certify a CRM for Factor II genetic disorder and consideration was made on the longer term for the production of cytochrom P450 polymorphism CRMs (important sequence for metabolism of pharmaceutics). Factor II and factor V are important to assess the risk of patients to get thrombosis;
- Interest of CDC (Atlanta, USA) in a co-operation with IRMM in the field of bone/osteoporosis markers (pyridinoline and deoxypyridinoline) was expressed. The CRMs have been characterised by ID-MS at CDC and CDC would like to make them available as CRMs for IRMM;
- Interest of the IFCC working group on osteocalcin to co-operate with IRMM and to certify two purified isoforms was expressed;
- Preparation of a draft "revenue of sales agreement" for various subunits of chorionic gonatropin. The material is already available and its value has been estimated at 900.000.
Output Indicators and Impact
IRMM and IFCC will stimulate global collaboration for the establishment of reference systems for in vitro diagnostic measurements - collaboration is presently being negotiated with NIST (USA), BIPM (Paris) and NMIs. Clinical CRMs to support the implementation of the IVD Directive will be produced followed by the necessary studies to characterise them. The Reference Materials unit at IRMM is presently being extended to include special laboratories for the production of potentially infectious clinical reference materials and for CRMs related to genetic diseases - an area of future importance for clinical chemistry and the healthcare sector, especially with increasing knowledge on the human genome. First studies towards human genome reference materials will be launched. Global networking and collaboration with IVD producers via IFCC should increase not only to ensure the efficient implementation of the IVD Directive in Europe but also to achieve worldwide comparability of clinical measurements and consequently mutual recognition of clinical reference materials and measurements.
Summary of the project
Certified Reference Materials (CRMs) are needed to ensure the reliability and comparability of measurements in clinical chemistry. IRMM has unique facilities and expertise for the production of clinical CRMs. The project is demand driven wherein the main customers are the International Federation of Clinical Chemistry (IFCC), the in-vitro diagnostics producers (particularly SMEs), clinical laboratories and hospitals.
Rationale
The stated purpose of the European "in vitro diagnostic (IVD) Directive" (98/79/EC) is to eliminate trade barriers within Europe and to ensure better measurements for healthcare decision-making, by creating a single channel of approval for all IVD products within the European Union. It requires, more specifically, from manufacturers of in-vitro diagnostics who wish to sell their products in the EU, that they demonstrate that these are "traceable to reference systems (e.g. reference materials and/or reference methods) of a higher order". A direct consequence of this new situation is that an enormous need of internationally recognised certified reference materials (CRMS) has been generated. At present, however, neither CRMs nor reference methods are available for quite a number of the analytes measured in clinical laboratories. It is the common interest of IRMM and IFCC to stimulate global collaboration for the establishment of reference systems for in vitro diagnostic measurements.
IRMM has developed unique high technology equipment and expertise for the highly efficient production of a large variety of highest quality clinical reference materials. The Reference Materials laboratory at IRMM is considered to be the best RM production facility in the world and hosts a unique multi-functional and flexible production laboratory, clean chambers, cryo grinding, freeze drying, high purity milling and ultra fine classification. This highly flexible laboratory can quickly adapt its production facilities to cater for urgent requests that stem from the policy makers, the healthcare sector and has a modern adjoining analytical laboratory fully equipped to monitor and control the production process.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- medical and health sciences clinical medicine angiology vascular diseases
- medical and health sciences clinical medicine endocrinology diabetes
- natural sciences biological sciences genetics genomes
- natural sciences biological sciences biochemistry biomolecules proteins enzymes
- natural sciences biological sciences molecular biology
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Coordinator
B-2440 Geel
Belgium
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