JSM 2005 - Toronto

Abstract #304362

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 439
Type: Topic Contributed
Date/Time: Wednesday, August 10, 2005 : 2:00 PM to 3:50 PM
Sponsor: Section on Statistics in Epidemiology
Abstract - #304362
Title: Precision and Accuracy of an Analytical Method: Total Error of Measurement
Author(s): Beimar Iriarte*+
Companies: Abbott Laboratories
Address: 1436 Vineyard Drive, Gurnee, IL, 60031, United States
Keywords: Accuracy ; Precision ; Total Error ; Total Error Allowable
Abstract:

Variability of measurement is inherent to an analytical method. There is an analytical total error associated with every measurement. For a medical diagnostic analytical method, the amount of total error that can be tolerated without invalidating the medical usefulness of the test is known as Total Error Allowable (TEa). This TEa can be considered a design performance goal for the manufacturer of a diagnostic test. The TEa is most relevant at levels where shifts of the measured are medically important for diagnostic accuracy. The TEa is derived and related to the intrinsic biological variability of the measured in an individual and between individuals in the normal population. The Total Error (TE) can be portioned into Systematic Error (SE) and Random Error (RE) to reflect the accuracy and precision of the method, respectively. This Total Error can then be compared to the Total Error Allowable to derive a performance metric (Sigma level), which is associated with the rate of exceedance of the TEa. The relationships between Total Error, Total Error Allowable, and Sigma metric can be displayed in a Method Decision Chart.


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Revised March 2005