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ANALYTICAL PERFORMANCE SPECIFICATIONS (APS): MOVING FROM MODELS TO PRACTICAL RECOMMENDATIONS.

Ideally APSs are criteria that specify (in numerical terms) the quality required for analytical performance to deliver laboratory test information that would satisfy clinical needs for improving health outcomes.

The aim of this conference is to go through and discuss the three different models agreed by the Milan 2014 EFLM Strategic Conference to set APS for the medical laboratory and to give practical examples on how this can be done.
 

Time Thursday October 12, 2023
12:30 - 13.30 Registration
  Opening and Introduction
Moderators: Mauro Panteghini – Sverre Sandberg
13:30 - 13:40 Welcome
– Tomas Zima
– Tomris Ozben
13:40 - 14:10 What the Milan conference about APS model definition and measurand allocation has taught us
– Mauro Panteghini
14:10 - 14:30 What do we want to achieve during this conference
– Sverre Sandberg
  Session 1: The role of APS in providing a suitable laboratory contribution to patient care
Moderator: Mario Plebani
14:30 - 14:50 The role of APS in international guidelines and standards dealing with metrological traceability in Laboratory Medicine
– Greg Miller
14:50 - 15:10 The role of APS in validating measuring systems: the IVD manufacturer’s perspective
– Victoria Petrides (Abbott)
15:10 - 15:30 How medical laboratories select and use APS
– Ferruccio Ceriotti
15:30 - 15:50 Discussion
15:50 - 16:20 Coffee break
  Session 2: Further developments and examples in the use of the three Milan models
Moderator: Elvar Theodorsson
16:20 - 16:50 Outcome-based model: how to fill the gap between the need of adequate studies and the lack of them. Examples
– Andrea Rita Horvath
16:50 - 17:10 Discussion
17:10 - 17:45 The biological variation model and the EFLM database for Biological variation
– Sverre Sandberg
17:45 - 18:10 Discussion
18:10 - 18:40 State-of-the-art model: How to define the highest level of analytical performance technically achievable. Examples of APS
– Francesca Borrillo
18:40 - 19:00 Discussion

 

Time Friday October 13, 2023
  Session 3: APS in different applications
Moderator: Greg Miller
08:30 - 09:00 APS for combined uncertainty budget in the implementation of metrological traceability
– Mauro Panteghini
09:00 - 09:30 How to use APS for lot-to-lot reagent and calibrator variation
– Marc Thelen
09:30 - 10:00 How to use APS for EQA/PT schemes
– Dalius Vitkus
10:00 - 10:30 How to use APS in a single laboratory
– Graham Jones
10:30 - 11:00 How to use APS in a healthcare system assembling multiple laboratories
– Elvar Theodorsson
11:00 - 11:30 Coffee Break
11:30 - 12:30 General discussion, summing up and further work
– Sverre Sandberg