Topic: Practical Training
Podium Presentation in Room 6 on Wednesday at 11:00 (Chair: Elizabeth Frank / Jacqueline Hubbard)
Authors: Elizabeth Frank, Kelly Doyle
Session description: Although assessment of reference intervals (RIs) is an integral component of laboratory medicine practice and so a requirement of LC-MS/MS assay development, establishing RIs using the traditional approach as described in the Clinical and Laboratory Standards Institute (CLSI) guidelines may not be feasible due to limited resources. Direct sampling is complicated by insufficient access to patients within varying interval partitions (e.g., pediatrics, pregnancy), 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, particularly if multiple partitions based on characteristics such as age and sex are required or if selection criteria would cause much of a general healthy population to be excluded from participation in the study.
Numerous techniques designed to identify the distribution of healthy values in an uncharacterized dataset have been proposed. Recent reports have exposed flaws in the application of some techniques and reveal the need for careful evaluation of indirect methods to avoid potential limitations of these techniques and ensure development of accurate reference values.
In this practical training course, we will provide a brief review of the concept of RIs and the fundamentals for establishing, transferring, and verifying RIs. Our experience evaluating RIs for various LDT mass spectrometry assays with differing patient populations will be presented and examples of indirect methods using stored patient data to estimate RIs will be discussed.
Take Home Pearls
Attendees will gain knowledge of
1. Establishment and use of reference intervals in clinical laboratory practice.
2. Regulatory and guidance documents for establishing, transferring and verifying reference intervals.
3. Appropriate application of direct and indirect methods to determine population/sex/age-based reference intervals.
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