Dear Colleagues:
As co-chairs of Working Group 1 of the Joint Committee on Traceability in Laboratory Medicine (JCTLM), we are requesting your assistance in gathering information for the nomination and review of “Reference Materials and Reference Methods and/or Procedures of higher order” required for compliance with European Directive 98/79/EC on in vitro diagnostic (IVD) medical devices. Further information about the activities of the JCTLM in general -- and Working Group-1 in particular -- and the procedure for nomination of Reference Materials or Reference Methods is provided below.
IF, after reviewing this request, you wish to nominate a method or material, please use the attached Excel file containing 4 spreadsheets:
· Reference Materials Template illustrated with examples
· Reference Methods Template illustrated with examples
· Blank Reference Materials Template to be completed with your nominations
· Blank Reference Methods Template to be completed with your nominations.
The schedule for the nomination and review process is as follows:
· Completed Spreadsheets to be returned to by 01 December 2002
· Information provided on spreadsheets will be sorted and provided to the Review Teams in early January 2003
· Progress Reports from each Review Team will be presented and discussed at a JCTLM WG-1 Meeting in Geel, Belgium in Early March, 2003
· Recommendations for “Reference Methods and Reference Materials of Higher Order” will be made -- by analyte category -- at a Plenary Session of the JCTLM at the BIPM on 20 June 2003.
As you are perhaps aware, the EC IVD Directive was published on December 7, 1998, marking the start of a transition period of five years. By December 2003 all new IVD products that are placed on the market must be labeled with the CE mark. Alternatively, it remains possible to place new IVD products on the market under the old national regulations until December 2003, and it remains allowed to put already existing IVD products without a CE mark into service until December 2005. Further information regarding this directive can be found at the website - http://www.tuvam.com/services/fitness/downloads/ivd.pdf.
One of the major components of this Directive is a requirement that “the traceability of values assigned to calibrators and control materials for in vitro diagnostic devices must be assured through available reference measurement procedures and/or reference materials of higher order”. The definition of the term “higher order” was left undefined in the Directive. There are, however two ISO Draft Standards (ISO/FDIS 15193 and 15194) that describe the essential requirements for higher order reference materials and methods.
To facilitate the identification of these methods and materials, The Joint Committee on Traceability in Laboratory Medicine (JCTLM) was created at a meeting held at the BIPM in early June 2002. The aim of the Joint Committee is to meet the need for a worldwide platform to promote and give guidance on internationally recognized and accepted equivalence of measurements in Laboratory Medicine and traceability to appropriate measurement standards. The JCTLM created two working groups:
· Reference Materials and Reference Procedures
· Reference Laboratory Networks.
The Terms of Reference for Working Group 1, currently co-chaired by Dr. Willie E. May from NIST (USA) and Dr. Heinz Schimmel, from IRMM (Belgium), are to identify Reference Materials and Reference Procedures and endorse those appropriate to meet the requirements of the EC Directive regarding in vitro diagnostic medical devices.
Prof. Dr. Lothar Siekmann, University of Bonn (Germany) and Prof. Dr. Linda Thienpont, University of Ghent (Belgium) were appointed as Co-Chairs of Working Group-II. The Terms of Reference of Working Group 2 are to:
· Collect information on existing and candidate reference measurement laboratories (RMLs)
· Encourage and facilitate the formation of networks of RMLs for different groups of measurable quantities (concerning electrolytes, substrates/metabolites, enzymes, HbA1c, low molecular hormones, ...)
· Establish a procedure for the approval of RMLs on the basis of their metrological level according to ISO 15195 and their performance as demonstrated in inter-laboratory comparisons linked to an NMI.
The first task for these two Working Groups is to provide practical support to the Worldwide IVD industry with respect to the traceability of values assigned to calibrators and/or control materials required by the European Directive on in vitro diagnostics and by comparable regulations in other countries.
JCTLM Working Group-I met at NIST on 28-29 August 2002. The agenda for that meeting is a provided as Appendix I. At this meeting, we (JCTLM-WG1) decided to move forward by putting out an open solicitation for candidate Reference Methods and Certified Reference Materials that might be included in a listing (perhaps ultimately a database) of “reference methods and reference materials of higher order”.
In order to facilitate the review process, WG1 has organized into Review Teams based on analyte category (Appendix II). We are asking that information be returned to us in a common format defined by the attached Templates for Reference Materials and Reference Methods respectively. We have assured, to the extent possible, that each Review Team has representation from IVD manufacturers, National Metrology Institutes, accreditation organizations, and professional societies from the US, Europe, and Asia Pacific.
As stated earlier, completed Spreadsheets to be returned to by 01 December 2002. Information provided on spreadsheets will be sorted and provided to the Review Teams in early January 2003. Progress Reports from each Review Team will be presented and discussed at a JCTLM WG-1 Meeting in Geel, Belgium in Early March, 2003. Recommendations for “Reference Methods and Reference Materials of Higher Order” will be made -- by analyte category -- at a Plenary Session of the JCTLM at the BIPM on 20 June 2003.
The Templates are intended to solicit most of the information that will be required for the Review Teams to make their assessments. However, the Review Teams might need to request additional information for some or all of your nominations, so please make sure to complete the “Contact Information for Additional Details” field of each Template.
Working Group II is now in the process of soliciting nominations for candidate reference measurement laboratories to provide “calibration services” for the analyte categories listed earlier. For additional information concerning the Reference Laboratory nomination process, please contact:
Dr. Angela E Samuel, JCTLM Secretariat
Bureau International des Poids et Mesures
Pavillon de Breteuil
F-92312 Sèvres Cedex
FRANCE
Tel: +33 1 4507 6272
Fax: +33 1 4534 8670
E-mail:
If there are questions about Working Group-I activities in general or any particulars about the Reference Method and/or Reference Materials review process, please contact:
Dr. Willie E May
National Institute of Standards and Technology (NIST)
Chemical Science and Technology Laboratory/Analytical Chemistry Division
ACSL (227), Room A109, MS 8390
Gaithersburg, Maryland 20899-8390
UNITED STATES
Tel: +1 301 975 3108; Fax: +1 301 926 8671
E-mail:
Dr. Heinz Schimmel
Institute for Reference Materials and Measurements (IRMM)
European Commission - Directorate General JRC
Retieseweg
B-2440 Geel
BELGIUM
Tel: +32 14 571 720; Fax: +32 14 590 406
E-mail:
Appendix 1
JCTLM Working Group-I Agenda
Reference Materials and Reference Measurement Procedures
Chair: W. May (NIST), M. Grasserbauer (JRC-IRMM)
Wednesday, August 28, 2002
National Institute of Standards and Technology
9:00 Welcome, Introductions, and Meeting Scope
9:30 EU IVD Directive: Interpretation and Clarification of Traceability Requirements
10:00 Higher Order Reference Materials and Procedures: Stakeholder Needs
· AACC
· ADVAMED
· CAP
· EDMA
· EQALM
· FDA
· IFCC
· ILAC
· JACR
· NIBSC
Noon Lunch
13:00 Higher Order Reference Materials and Procedures: Ongoing Activities
· CENAM
· IRMM
· LGC
· NIST
· NMIJ
· PTB
· EU Projects
15:00 Coffee
15:15 Criteria for Higher Order Reference Materials and Procedures
16.00 Higher Order Reference Materials and Procedures: Resources and Tools Currently Available
· BIPM Database [Internationally Vetted Reference Methods and Materials]
· BCR-IRMM CRMs
· WHO RMs
· RMs of other providers
· AACC Reference Methods
JCTLM Working Group-I Agenda
Reference Materials and Reference Measurement Procedures
Chair: W. May (NIST), M. Grasserbauer (JRC-IRMM)
Thursday, August 29, 2002
National Institute of Standards and Technology
9:00 Establishing List of Category A and Category B Measurands
10:30 Coffee
10:45 Relationship Between Duties of JCTLM WG-1 and WG-2
11:15 Other issues
Noon Adjourn
13:00- 15:00 Laboratory Visits
Appendix 2
Analyte categories
[The measurands listed under the various “Analyte categories” are not meant to represent an exhaustive list; but rather only examples of the types of analytes that would be representative of each of the Analyte Categories.]
Highest Priority
Analyte Category Review Team Chair
(With representative examples)
Electrolytes Richard Miller, Dade Behring
Calcium
Chloride
CO2
Lithium
Magnesium
Potassium
Sodium
Enzymes Mauro Panteghini, Azienda Ospedaliera “Spedali Civili”
AST
ALT
AMYLASE
CK
GGT
Metabolites and Substrates Michael Welch, NIST
Cholesterol
Creatinine
Glucose
Urea
Uric Acid
Triglycerides
Lactate
Proteins David Sogin, Abbott Laboratories
Albumin
Troponin-I
PSA
Nucleic Acids Helen Parkes, LGC
Drugs Andre Henrion, PTB
Digoxin
Digitoxin
Dilantin
Phenobarbital
Theophylline
Tegretol
Valproic Acid
Cocaine
Delta-9 THC
Hormones (Non-Peptide) Heinz Schimmel, IRMM
Aldosterone
Cortisol
Estradiol-17ß
Estriol
Progesterone
17-Hydroxy-progesterone
Testosterone
Thyroxine
Coagulation Factor TBD
Medium Priority
Vitamins TBD
Non-Electrolyte Metals TBD