# Presentation: 461280

## Process for Evaluating Reference Materials and Methods of a Higher Order

- R. Miller
- Electrolytes Review Team
- 22 July 2003

## Agenda

- Overview
- Nomination Process
- Selection Process
- Discussion of Findings
- Status of recommendations

- JCTLM Manufacturer's Update 22 July, 2003

## WG1 Analyte Review Teams Goal

- Identify  reference materials and reference procedures and recommend for endorsement by the JCLM WG 1 those appropriate to meet the EC requirements regarding In Vitro Medical Devices
- Limited to specific analyte class (I.e. electrolytes, metabolites, proteins
- Although the main driver is the IVD Directive, the interest of the group is not limited to any one geographical region or trade issue.

- JCTLM Manufacturer's Update 22 July, 2003

## The Team Leaders

- Electrolytes 	R. Miller		Dade Behring
- Enzymes		Dr. M. Panteghini	Azienda Ospedalera
- Metabolites		Dr. M. Welch		NIST
- Drugs		Dr. A. Hendrion	Physikalisch- Technische 						Bundesanstalt
- Proteins		Dr. D. Sogin		Abbott
- Coagulation 	Dr. E. Gray		NIBSC
- Nucleic Acids	Dr. H. Parks		Laboratory of The 							Government Chemist, 						Middlesex
- LMW Hormones	Dr. Heinz Schimmel	IRMM

- JCTLM Manufacturer's Update 22 July, 2003

## The Process

- Nominations solicited - (Via NIST & B IPM)
- Spreadsheets developed for nominations One for Reference Methods, One for Reference Materials
- Recruited Teams - 6-16 persons/team
- Well Balanced Geographically
- Balance of representation from NMIs, Clinical Laboratories, IVD Industry, Reference Laboratories
- Received 436 nominations for reference materials and 79 for reference methods

- JCTLM Manufacturer's Update 22 July, 2003

## The Process Continued

- Members of the teams divided the work by analyte
- Used ISO 15193 and ISO 15194 as guides
- Reviewed the Nominations
- Individuals made recommendations to the group
- Group input used to obtain consensus
- Prepared recommendation for June 20 2003 JCTLM Meeting

- JCTLM Manufacturer's Update 22 July, 2003

## Materials Nomination Spreadsheet

- JCTLM Manufacturer's Update 22 July, 2003

## Materials Nomination Spreadsheet - cont.

- JCTLM Manufacturer's Update 22 July, 2003

## Laboratory Review

- The review teams are also starting to review the nominated laboratories for compliance to EN/ISO 15195.  As described by Dr Thienpont.
- The results of this first review is expected to be completed this fall.

- JCTLM Manufacturer's Update 22 July, 2003

## Key Issues   

- Many of the methods and materials were designed before the standards were available and do not meet _all_ of the elements of the standards
- Recommend, for formatting requirements, that they be recommended (unconditionally)
- Recommend, for certain technical requirements, that they be provisionally recommended referring the specific issues to WG3 for a plan for addressing them

- JCTLM Manufacturer's Update 22 July, 2003

## Key Issues

- Commutability - Many materials state that the material is either a trueness control or is to be used with “field” or clinical methods but commutability data for that analyte does not exist.
- Recommend - If the certificate states that the material is intended for use as a trueness control or in the calibration of clinical procedures the material will be recommended conditionally if commutability studies are not available.

- JCTLM Manufacturer's Update 22 July, 2003

## Key Issues

- Recommend a clarification of commutability requirements in the future
- When needed
- How to determine
- How to report

- JCTLM Manufacturer's Update 22 July, 2003

## Key Issues

- Some materials do not have uncertainty estimates on the values assigned.
- The IVD manufacturers must understand the uncertainty of the reference material so they may use it in their uncertainty estimates (this is a requirement of ISO 17511)
- Recommendation still under consideration

- JCTLM Manufacturer's Update 22 July, 2003

## Recommendations to the JCTLM

- The Review Teams for Electrolytes, Enzymes, Drugs and Metabolites have made recommendations regarding Methods and Materials.  These lists, one  for methods and another for materials, have been segmented into 3 groups.
-  - fully compliant
- - not fully compliant but still recommended
- - not recommended

- JCTLM Manufacturer's Update 22 July, 2003

## Recommendations to the JCTLM

- Recommendations for low molecular weight hormones will be made in September.
- For the “type B” analytes/measurands (proteins, coagulation, nucleic acids), there is still difficulty in uniformly applying the ISO Standards.  Work is continuing.

- JCTLM Manufacturer's Update 22 July, 2003

## Final Work Product

- The final work product will be a single list of acceptable materials and methods to be published in the Fall and updated on a periodic basis.
- The current plan is to publish it on the BIPM/JCTLM web site when it is available this fall  (http://www.bipm.fr/enus/2_Committees/JCTLM.shtml)

- JCTLM Manufacturer's Update 22 July, 2003

- JCTLM Manufacturer's Update 22 July, 2003