Day1
May 27, 08:30 –17:45
HIGH-PRIORITY REFERENCE MATERIALS FOR TRACEABILITY
IN LABORATORY MEDICINE – FILLING THE GAP

Session description: The total number of clinically relevant analytes measured routinely has been estimated at over 2000. Some analytes are measured very frequently and others less. To adhere to regulatory requirements in vitro diagnostics (IVDs) specific analytes are classified as high or a lower risk determined by the intended purpose of the IVD and the inherent risks of inadvertent false positive or negative results. The global harmonization of laboratory medicine is facilitated by the development and implementation of Reference Measurement Systems including appropriate Certified Reference Materials (CRMs). There are a relatively small but growing number of national laboratories that are able to produce CRMs for these applications worldwide. With these limited resources the prioritization of efforts is key as is the interaction of different producers in meeting global needs for the highest priority CRMs that ensures supply and maximises the number of analytes that can be covered with sufficient redundancy.

Goals:

• Understand the current prioritization exercises that exist and their level of consistency;
• Understand the current activities on-going to meet high priority CRM development and maintenance needs;
• Make recommendations on how optimised efficiency of the processes for filling the gap of missing CRMs, maintenance of CRM supply, and optimised redundancy of CRMs can be achieved.

Day2
May 28, 09:00 –16:30
ESTABLISHING METROLOGICAL TRACEABILITY TO INTERNATIONAL SYSTEM OF UNITS (SI)
FOR SERUM AND URINARY ALBUMIN MEASUREMENTS

Session description: Albumin measurements in serum and urine have important diagnostic and prognostic roles. However, non-standardized measurement procedures are still used in medical laboratories. While much progress toward providing tools for standardizing urine albumin measurements has been made in the last 15 years, serum albumin still lacks an approach for the implementation of metrological traceability to the SI, starting by employing alternative methods for CRM characterization. This workshop will provide an analysis of the current status of Reference Measurement System components for serum and urine albumin measurements, including discussion on how to improve standardization and highlighting some important aspects that still require clarifications. The discussion will also be useful for IVD manufacturers when introducing changes in metrological traceability of serum and urine albumin measurement procedures to assure traceability to SI.

Goals:

• Provide a comprehensive analysis of metrological traceability tools for standardizing urine albumin measurements;
• Understand the interchangeability of available higher-order CRMs and reference measurement procedures when employed to establish metrological traceability of IVD measurement procedures for urine albumin to SI;
• Discuss about analytical performance specifications that should be fulfilled when using serum and urine albumin measurements for patient management decisions;
• Agree on how to redesign the approach needed for the implementation of metrological traceability to the SI for serum albumin and plan the related studies.