TL19: Measuring Interval
*Vicki Petrides, Abbott Diagnostics Keywords: The terms measuring interval, reportable range and analytical measuring range have all been used to describe the values that can be quantified and reported by an in vitro diagnostic test. The concepts may seem straightforward, but there is debate about which studies should be used for manufacturers to establish and laboratories to verify a measuring interval. Traditionally the limit of quantitation (LoQ), linearity, precision and method comparison data serve as the key studies to establish a measuring interval. One question for developers is, how close to the limits of the measuring interval do the samples tested need to be in order to support the claim? Another challenge in meeting the current expectations is that the current consensus guidance on linearity, CLSI EP6-A, suggests testing samples 20 – 30% above the desired measuring interval. While manufacturers may follow this advice, one could argue that doing so does not make sense as by definition, the assay cannot accurately quantify above the upper limit of the measuring interval. An additional question that often arises is what evidence is necessary to support a claim for a new product with a desired measuring interval that is larger than that of the predicate device? Should new products be limited by the upper limit of the predicate’s measuring interval? Please join us in discussing these questions as we hear the perspectives of FDA, industry and laboratory speakers.
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Key Dates
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November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC