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Activity Number: 343
Type: Contributed
Date/Time: Tuesday, July 31, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #304397
Title: Operating Characteristics in Assessing Agreement Between Two Instruments of Quantitative Measurement
Author(s): Jeng Mah*+
Companies: Beckman Coulter
Address: 3339 Owasso Height Road, Shoreview, MN, 55126, United States
Keywords: Measurements of accuracy ; actionable decision ; true positive rate ; true negative rate ; simultaneous operating characteristics

The accuracy of a new instrument or assay is typically assessed by the agreement between measurements of identical samples made by the test and established instruments. Agreement is quantified in multiple dimensions, e.g. differences (Bland-Altman, 1983) and linear relationship (Passing-Bablok, 1983) between measurements pairs. These measurements provide informational, quantitative representations of agreement. However, there is no simple way to determine how much agreement is enough for the new instrument to be deemed accurate. Consequently, the effect of the agreement thresholds used to render an actionable decision, i.e. instrument-level pass/fail, on the accuracy of the evaluation is not well known.

We examine the accuracy of a dichotomous decision based simultaneously on estimations in limit of agreement and the slope and intercept of a linear regression between the measurements when assessing a new instrument or assay. The probabilities of accepting an accurate instrument and rejecting an inaccurate one, dependent on the choice of decision thresholds and pre-defined specifications of accuracy, are examined using simulated data with known instrument accuracies.

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