= Emerging. More than 5 years before clinical availability. (16.60%, 2024)
= Expected to be clinically available in 1 to 4 years. (37.02%, 2024)
= Clinically available now. (46.38%, 2024)
MSACL 2024 : Shi

MSACL 2024 Abstract

Self-Classified Topic Area(s): Small Molecule > Tox / TDM / Endocrine > Assays Leveraging Technology

Podium Presentation in Steinbeck 1 on Thursday at 10:30 (Chair: Angela Fung / Nicholas Spies)

The Old Assay in the New Era: Re-Evaluation of Mass Spectrometric Immunosuppressant Assay

Junyan Shi (1, 2), Meng Wang (1)
(1) Vancouver General Hospital, Vancouver Coastal Health, Vancouver, Canada (2) Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, Canada

Junyan Shi, PhD, DABCC, FCACB (Presenter)
Vancouver Coastal Health, University of British Columbia

Presenter Bio: Dr. Shi earned her doctoral degree from the University of British Columbia in Canada, and subsequently completed a Clinical Chemistry fellowship at the University of Washington Medical Center in the United States. She holds both American and Canadian board certifications in Clinical Chemistry. Dr. Shi serves as a clinical biochemist at Vancouver General Hospital and the discipline lead of the tumor marker laboratory. During her training, Dr. Shi developed a strong interest in clinical proteomics, focusing on harnessing the potential of mass spectrometry for the quantitative analysis of large molecules in clinical applications. She actively contributes to knowledge translation through presentations at ADLM (formerly AACC) and MSACL. Her clinical research work, involving the mass spectrometric analysis of thyroglobulin, apolipoprotein A1, and ACTH, has been published in the Journal of Mass Spectrometry and Clinical Chemistry and Clinical Chemistry, respectively.


Introduction: The number of solid organ and stem cell transplantation continues to increase worldwide, Organ transplantation is a multidisciplinary field, requiring a diverse community of professionals to collaborate to support various transplant programs. Clinical laboratories play pivotal roles encompassing all phases of transplantation including pre-transplant, transplant, and post-transplant stages. While non-specific tests such as serum creatinine/eGFR, liver enzymes, complete blood counts are useful for routine investigation, transplant-specific tests guide more important clinical decision-making and ultimately impact clinical outcomes in transplant recipients. Therapeutic Drug Monitoring (TDM) for immunosuppressants (cyclosporine, tacrolimus, and sirolimus) stands at the intersection of precision medicine and efficient healthcare delivery, ensuring optimal drug dosages and minimizing adverse effects. In this rapidly evolving era, laboratories encounter significant challenges, from method selection concerns to operational optimization and the need for data-driven insights.

Objectives: The study aims to explore the challenges in immunosuppressant testing using mass spectrometry, provide solutions to optimize the entire workflow, and demonstrate how data analytics can greatly facilitate decision-making to maximize efficiency and quality in clinical laboratories.

Methods: Clinical-driven and data analytics-based approaches were applied to examine the bottlenecks of the laboratory-developed mass spectrometric immunosuppressant assay that has been in routine clinical use for over two decades. We conducted a retrospective data analysis from the laboratory information system, utilizing open-source R software, to identify trends in test volume, test order patterns for both inpatient and outpatient settings, turn-around time, and variations in efficiency among technologists. To address the identified barriers throughout the entire workflow, we introduced solutions at various phases. In the pre-analytical phase, we developed new sample batching and processing strategies. In the analytical phase, we re-evaluated the existing assay to improve run time and throughput. In the post-analytical phase, we reinforced procedures aimed at improving the quality of results.

Results: Over the past two decades, the total test volume of immunosuppressant testing has substantially increased by 4 folds in our laboratory, rising from 30 samples to 120 samples per day. Inpatients and outpatients from transplant clinics of our hospital contributed to 58% of the total volume. The majority of inpatient samples were received before 10am, while the majority of outpatient samples were received before 12pm. Our analysis revealed that the delay occurring in the analytical phase, as opposed to the delay from collection to receipt in the pre-analytical phase. Furthermore, we observed substantial variation and inconsistency in turn-around times among different technologists. The new workflow and the modified mass spectrometric method resulted in significant reduction in the turn-around time, an increase in testing throughput, improvement in assay precision by minimizing variations among technologists, as well to help alleviate staffing shortages to some extent from the operational perspective.

Conclusion: This study highlights the significance of re-evaluation of laboratory-developed immunosuppressant assay to meet the growing demands from transplant patients. By leveraging data analytics, we were able to objectively identify workflow bottlenecks and facilitate informed decision-making in clinical laboratories. The implementation of improvements aimed at enhancing efficiency and quality provided a model in addressing the evolving clinical needs and staffing shortages.

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