= Emerging. More than 5 years before clinical availability. (24.37%, 2023)
= Expected to be clinically available in 1 to 4 years. (39.50%, 2023)
= Clinically available now. (36.13%, 2023)
MSACL 2023 : Doyle

MSACL 2023 Abstract

Self-Classified Topic Area(s): Practical Training

Podium Presentation in Colton on Thursday at 15:15 (Chair: TBA)

Practical Guidance and Examples of Estimating Reference Intervals by Indirect Methods for LDT Mass Spectrometry Assays

Kelly Doyle (1,2), Elizabeth Frank (1,2)
(1) University of Utah Health, (2) ARUP Laboratories

Kelly Doyle, PhD (Presenter)
University of Utah Health / ARUP Laboratories

Presenter Bio: I am a board certified clinical chemist (DABCC) with research and clinical interests in mass spectrometry, pediatrics, endocrinology, and toxicology.

I am fortunate to be engaged in clinical service and education. I enjoy collaborating on laboratory processes optimization, development of robust methods, and in efforts focused on improving patient care.

I received a Ph.D. in Medicinal Chemistry and completed a ComACC accredited fellowship the Department of Pathology at the University of Utah School of Medicine in Clinical Chemistry.



Reference intervals (RIs) are an integral component and regulatory requirement of laboratory medicine practice and LC-MS/MS assay development. Establishing RIs using the traditional approach by direct sampling is complicated by insufficient access to patients within varying interval partitions (e.g., pediatrics), and adoption or transferring of RIs is hindered by lack of assay standardization and unique population demographics. However, indirect sampling techniques using laboratory database results have significant practical advantages compared to direct sampling methods. The use of stored patient data can offer a faster and less costly means to developing RIs. Modernized approaches, based on ready to use R packages and web-interfaced applications, can aid in the development of accurate reference values. The aim of this presentation is to demonstrate the utility of refineR, Truncated Minimum Chi-Square (TMC), and kosmic indirect methods. Clean up and characterization of data sets as well as the indirect comparison tool, RIBench, will be discussed.

Take Home Pearls:
1. Learn how indirect methods are used to estimate reference intervals in clinical laboratory practice.
2. Understand how data preparation and characterization are necessary prior to use in indirect methods.
3. Gain practical knowledge in the use of novel indirect methods to estimate population/sex/age-based reference intervals.

Financial Disclosure

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IP Royaltyno

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