Information on Bio- Metrology and Measurement Standards in Biosciences

Transcription

1 RM-Unit, HS, Ispra, 5 June th Meeting of the EC-US Task Force on Biotechnology Research 1 Information on Bio- Metrology and Measurement Standards in Biosciences Heinz Schimmel IRMM - Institute for Reference Materials and Measurements Geel - Belgium

2 RM-Unit, HS, Ispra, 5 June th Meeting of the EC-US Task Force on Biotechnology Research 2 Quantification of DNA/nucleotides and proteins/peptides Biotech R&D at JRC-IRMM Bioanalytical Research Health Reference Measurement Systems Evaluation of BSE/TSE tests Prions TSE QCMs RM Developments International harmonisation & standardisation Clinical CRMs Enzymes Microorganisms Microbiol. CRMs Food/Feed CRMs DNA GMO CRMs Hormones Proteins

3 Bio-Science Measurement Challenges RM-Unit, HS, Ispra, 5 June th Meeting of the EC-US Task Force on Biotechnology Research 3 Dealing with complex compounds: - Compounds are not clearly defined chemical entities and can be measured targeting different parts of the molecules. - Not only the amount of such compounds but also structure / degree of denaturation, fragmentation / isoform pattern, immunological reactivity and kinetics, biological activity (if relevant) and microenvironment/matrix effects are relevant. - Appropriate methods and calibrant reference materials, together with qualified laboratories forming a reference system, are required to come up with reliable and comparable measurement data.

4 Standardisation in Bio-Science RM-Unit, HS, Ispra, 5 June th Meeting of the EC-US Task Force on Biotechnology Research 4 - Involvement of all stakeholders (academia, reference laboratories, RM developers, industry) and proper understanding / definition of the analyte. - Biochemical skills to produce suitable calibrators and QA tools for complex analytes. - Sophisticated multiparametric measurement approaches / range of tools to characterise complex analytes sufficiently well required. - Assessment of suitability of calibrators.

5 RM-Unit, HS, Ispra, 5 June th Meeting of the EC-US Task Force on Biotechnology Research 5 Laboratories CLSI etc. Laboratories A-CRM ERM RM Producers IRMM NIST CIPM Standards Metrology issues REMCO Standardisation ISO Sector Organisations VAMAS Accreditation & Conformity assessment EA AOAC Codex etc. ILAC Laboratories Laboratories

6 Impact of ERM-DA470 RM-Unit, HS, Ispra, 5 June th Meeting of the EC-US Task Force on Biotechnology Research 6 Haptoglobin, HPT(KC EQAS data)

7 Impact of ERM-DA470 RM-Unit, HS, Ispra, 5 June th Meeting of the EC-US Task Force on Biotechnology Research 7 C reactive protein, CRP (KL EQAS data)

8 Impact of ERM-DA470 RM-Unit, HS, Ispra, 5 June th Meeting of the EC-US Task Force on Biotechnology Research 8 C reactive protein, CRP (KL EQAS data 2005) nephelometry turbidimetry fluorimetry dry chemistry

9 Bioscience Measurement Issues RM-Unit, HS, Ispra, 5 June th Meeting of the EC-US Task Force on Biotechnology Research 9 Consequences of lacking comparability and reproducibility of measurement results in Bioscience: - interpretation of data and decision making limited - diagnostic potential reduced - redundancies (verifications, repetitions) - inconsistencies hamper technical / scientific progress

10 Bio-Science Measurement Standards RM-Unit, HS, Ispra, 5 June th Meeting of the EC-US Task Force on Biotechnology Research 10 National or regional standards may help to harmonise measurement results within those regions, however: - Bioscience is an international playing field - Existence of local reference systems usually does not remove discrepancies in measurement results between regions and create technological and trade barriers Standardisation on international level desirable!

11 Customers / networks RM-Unit, HS, Ispra, 5 June th Meeting of the EC-US Task Force on Biotechnology Research 11 VAMAS CIPM CCQM ISO REMCO & TCs IFCC JCTLM ILAC AOAC EA CEN TREN Eurachem AGRI IES EURAMET ENV ERM Cooperation ENTR IHCP FSQ RM RTD IPTS IM Research groups SANCO TAXUD JRC IRMM ENGL CRLs EC CLSI ERA WW

12 JRC-IRMM collaborations RM-Unit, HS, Ispra, 5 June th Meeting of the EC-US Task Force on Biotechnology Research 12 - Collaboration agreement with NIST - Collaboration with IFCC - Representation in ISO TC s, e.g. ISO TC212 (clinical laboratory testing and in vitro diagnostic test systems) - Contributions to a CSLI standard on commutable reference materials C-53P - Discussion with WHO regarding their guidelines on standards preparation - Representation at JCTLM, issuing recommendations on the use of CRMs for IVD calibration - Participation in CCQM Bio-analysis Working Group

13 Overall support in QA RM-Unit, HS, Ispra, 5 June th Meeting of the EC-US Task Force on Biotechnology Research 13 Certificates Certification reports CRM development Guidance documents Application Notes On-line user support Training courses