Imprecision Studies for Qualitative Tests: A Framework
View Presentation *Marina Kondratovich, CDRH/FDA *Kristen Meier, CDRH/FDA Keywords: precision, qualitative diagnostic test Analogous to quantitative test, it is important to understand the imprecision (random variation) associated with a qualitative test. This talk will describe a framework and terminology for how to think about imprecision of a qualitative test and provide suggestions for how to evaluate it. This framework is described in recently published CLSI document EP12-A2 (2008): User Protocol for evaluation of qualitative test performance: Approved guideline, and it is also referenced in Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices, issued on January 30, 2008.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC