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Activity Number: 471 - Statistical Methods and Challenges in Diagnostic Medicine
Type: Contributed
Date/Time: Wednesday, August 2, 2017 : 8:30 AM to 10:20 AM
Sponsor: Section on Medical Devices and Diagnostics
Abstract #322417 View Presentation
Title: Essential Statistical Methods for Molecular Diagnostics
Author(s): Jesse Albert Canchola* and Pari Hemyari
Companies: Roche Molecular Systems Inc. and Roche Molecular Systems Inc.
Keywords: molecular diagnostics ; performance metrics ; assay development ; diagnostics clinical trials
Abstract:

Traditional molecular diagnostics is concerned with the development and optimization of the assay or test that is used to detect, diagnose or monitor a pathogen (e.g., bacterium, virus or other organism that may cause disease). Statistical performance metrics for assay development and optimization include, for example, precision, linearity, accuracy, sensitivity/specificity or method comparison. At this time, no single publication exists that substantially unifies the statistical methodologies used in molecular diagnostics. The authors endeavor to present these methodologies with relevant applications.


Authors who are presenting talks have a * after their name.

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