RM-Unit, HS, Ispra, 5 June 2008 – 18th 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 MeasurementsGeel - Belgium

http://irmm.jrc.ec.europa.eu/http://www.jrc.ec.europa.eu/

RM-Unit, HS, Ispra, 5 June 2008-18th Meeting of the EC-US Task Force on Biotechnology Research 2

Microbiol.CRMs Food/Feed

CRMs

TSEQCMs

ClinicalCRMs

GMOCRMs

Micro-organisms

Prions

Proteins

Enzymes

Hormones

DNA

Biotech R&D at JRC-IRMM

Evaluation of BSE/TSE tests

Bioanalytical Research

RM Developments

Health Reference Measurement

Systems

Quantification of DNA/nucleotides

andproteins/peptides

International harmonisation & standardisation

RM-Unit, HS, Ispra, 5 June 2008-18th Meeting of the EC-US Task Force on Biotechnology Research 3

Bio-Science Measurement Challenges

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 micro-environment/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.

RM-Unit, HS, Ispra, 5 June 2008-18th Meeting of the EC-US Task Force on Biotechnology Research 4

Standardisation in Bio-Science

- 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 characterisecomplex analytes sufficiently well required.

- Assessment of suitability of calibrators.

RM-Unit, HS, Ispra, 5 June 2008-18th Meeting of the EC-US Task Force on Biotechnology Research 5

Accreditation & Conformity assessment

ILACEA

Codexetc.

“Sector Organisations”AOAC

CLSI

VAMAS

RM Producers

ERMA-CRM

NIST

etc.

Metrology

CIPM

ISO

Standardisation

REMCO

Standardsissues

Laboratories

Laboratories

LaboratoriesLa

bora

torie

s

IRMM

RM-Unit, HS, Ispra, 5 June 2008-18th Meeting of the EC-US Task Force on Biotechnology Research 6

Impact of ERM-DA470

Haptoglobin, HPT(DGKC EQAS data)

RM-Unit, HS, Ispra, 5 June 2008-18th Meeting of the EC-US Task Force on Biotechnology Research 7

Impact of ERM-DA470

C reactive protein, CRP (DGKL EQAS data)

RM-Unit, HS, Ispra, 5 June 2008-18th Meeting of the EC-US Task Force on Biotechnology Research 8

Impact of ERM-DA470

C reactive protein, CRP (DGKL EQAS data 2005)

fluorimetry

nephelometry turbidimetry

‘dry chemistry’

RM-Unit, HS, Ispra, 5 June 2008-18th Meeting of the EC-US Task Force on Biotechnology Research 9

Bioscience Measurement Issues

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

RM-Unit, HS, Ispra, 5 June 2008-18th Meeting of the EC-US Task Force on Biotechnology Research 10

Bio-Science Measurement Standards

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 !

RM-Unit, HS, Ispra, 5 June 2008-18th Meeting of the EC-US Task Force on Biotechnology Research 11

VAMAS

ILAC

CIPMCCQM

CLSI

ISOREMCO & TCs

JCTLM

IFCC

WW

EA

CENEurachem

EURAMET ERMCooperation Research

groups ENGL

ERADG

TREN

DGAGRI

DGENV

DGENTR

DGRTD

DGSANCO DG

TAXUD

ECIES

IHCP IPTS

JRCIRMMIMFSQ

AOAC

RM

Customers / networks

CRLs

RM-Unit, HS, Ispra, 5 June 2008-18th Meeting of the EC-US Task Force on Biotechnology Research 12

JRC-IRMM collaborations

- 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

RM-Unit, HS, Ispra, 5 June 2008-18th Meeting of the EC-US Task Force on Biotechnology Research 13

Overall support in QA

Certificates Certificationreports

Guidancedocuments

On-line user support

Training courses

ApplicationNotes

CRM development