Gwen McMillin (Presenter)
Authorship: (1) Stephanie J. Marin, Ph.D., (2) Simuli L. Wabuyele, Ph.D., (3) Gwen A. McMillin, Ph.D.
(1) Biotage, Charlotte, NC, (2) ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT, (3) ARUP Laboratories, University of Utah Health Sciences Center, Salt Lake City, UT
Within the first two years of testing, volumes were taxing the laboratory resources such that the original assay was not sustainable. We were also starting to understand the strengths and weaknesses (clinical and analytical) of the assay so we wanted to make some improvements. In this section changes in homogenization and assay design, as well as a switch to LC-MS/MS will be discussed with outcomes on throughput and quality of results.
There is a misconception that once a developed and validated method goes live in the clinical lab, that is the end of the story; however, often issues with the performance of a clinical assay are discovered after months or years in the production lab. Assays often undergo modifications during their lifetime to address key issues with analytical/clinical performance, workflow, turn-around time, cost or increasing sample volumes. Many laboratory developed tests are eventually completely reworked and revalidated to meet the demands/needs for routine clinical utilization. This presentation will focus on the history of a clinical assay to detect drugs and drug metabolites in umbilical cord tissue by LC-MS/MS as an example.
Part 1 will review proof of concept studies, method development and initial validation of the assay. Part 2 discusses subsequent changes that were validated and implemented over time in the production lab and their effect on the performance of the assay. Part 3 presents how the assay was reworked and its status today.
Conclusions & Discussion
References & Acknowledgements:
1. Marin SJ, Christensen RD, Baer VL, Clark CJ, McMillin GA., Ther Drug Monit. 2011 Feb;33(1):80-5.
2. Marin SJ, Metcalf A, Krasowski MD, Linert BS, Clark CJ, Strathmann FG, McMillin GA., Ther Drug Monit. 2014 Feb;36(1):119-24.
3. Haglock-Adler CJ, McMillin GA, Strathmann FG., Clin Biochem. 2016 Sep;49(13-14):1092-5.
IP Royalty: no
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