Activity Number:
|
367
- Section on Medical Devices and Diagnostics P.M. Roundtable Discussion (Added Fee)
|
|
Type:
|
Roundtables
|
|
Date/Time:
|
Tuesday, August 1, 2017 : 12:30 PM to 1:50 PM
|
|
Sponsor:
|
Section on Medical Devices and Diagnostics
|
|
Abstract #324527
|
|
|
Title:
|
Design Specifications of Performance for an Analytical Laboratory Method
|
|
Author(s):
|
Beimar Iriarte*
|
|
Companies:
|
Abbott Laboratories
|
|
Keywords:
|
Uncertainty ;
Total Error ;
Equivalence ;
Quality specifications
|
|
Abstract:
|
This roundtable session will discuss current models and principles utilized in the setting of design specifications of performance of an analytical method or a laboratory test. It will review the principles for an acceptable/justifiable margin of equivalence in comparison studies. The session will also discuss and evaluate prevailing understanding of total error and uncertainty of measurement and approaches of estimation. It will explore analysis methodologies of equivalence of total error, as opposed to equivalence of bias and imprecision separately.
|
Authors who are presenting talks have a * after their name.
