= Discovery stage. (16.60%, 2024)
= Translation stage. (37.02%, 2024)
= Clinically available. (46.38%, 2024)
MSACL 2024 : Vogeser

MSACL 2024 Abstract

Self-Classified Topic Area(s): Small Molecule > Emerging Technologies > Assays Leveraging Technology

Podium Presentation in Steinbeck 3 on Wednesday at 14:10 (Chair: Robert Voyksner / Jessica Colón-Franco)

Pilot Study on the Prototype of a Fully Automated Mass-Spectrometry Based Clinical Laboratory Analyzer System

Michael Vogeser (1), Antje Reuter (2), Christian Schneider-Thauern (2), Katharina Habler (1)
(1) Hospital of the University of Munich, Institute of Laboratory Medicine, Munich, Germany (2) Roche Diagnostics GmbH, Mannheim, Germany

Michael Vogeser, Prof. Dr. med. (Presenter)
University Hospital, LMU Munich


Presenter Bio: Dr. Michael Vogeser, MD, is specialist in Laboratory Medicine and senior physician at the Hospital of the University of the Ludwig-Maximilians-University Munich, Germany (LMU; Institute of Laboratory Medicine). As an Associate Professor he is teaching Clinical Chemistry and Laboratory Medicine. The main scope of his scientific work is the application of mass spectrometric technologies in routine clinical laboratory testing as translational diagnostics. Besides method development in therapeutic drug monitoring and endocrinology a further particular field of his work is quality and risk management in mass spectrometry and in clinical testing in general. Michael has published >240 articles in peer reviewed medical journals. Michael heads the Commission for In Vitro Diagnostics in the German Association of Scientific Medical Societies (AWMF).)


OBJECTIVES: The main objective of this study was to investigate the practicality, robustness, turnaround time, and sample throughput of the prototype version of the fully automated MS-based analyzer. Investigating the analytical performance characteristics was not in focus, given the prototype status of all components.

METHODS: An evaluation program was performed by two experienced technicians from the Institute of Laboratory Medicine, University Hospital of LMU Munich, Germany, after a three-day training and familiarization program in Q3 and Q4 2022. Leftover clinical samples were used to simulate routine like conditions. The instrument studied is a fully automated and integrated solution for mass spec testing. Query downloading and result uploading was performed online, with the analytical system connected to a laboratory information system-like study tool.

In particular, the specified evaluation protocol included high-throughput random access simulations, daily QCs, stress testing, and a systematic assessment of overall reliability, using a number of representative assays. Operator experience and practicality were also systematically assessed.

RESULTS: The time to the first result was 37 minutes. Sample throughput in random access mode was up to 100 samples per hour. Ready to use reagent cartridges were loaded on the fly. Practicability on the level of state-of-the-art standard high-throughput analytical systems for clinical laboratories was observed, with automated timed start-up procedures, automatic shutdown, and extended walk-away times. Peak identification and quantification was fully automated without any need for user intervention. Already at this stage of the instrument development a high degree of calibration stability was observed. System-related run interruptions, as to be expected with a prototype, were noticed. However, in all cases, solvable root causes were identified and were the subject of further instrument development.

CONCLUSION: Based on our results, observations, and handling experience, we believe that further development and maturation of the system under study will most likely result in the first MS/MS-based analytical system that can be seamlessly integrated into comprehensive high-throughput, multi-technology laboratory solutions.

Financial Disclosure

GrantsyesRoche Diagnostics
Board MemberyesRoche Diagnostics
ExpensesyesRoche Diagnostics
IP Royaltyno

Planning to mention or discuss specific products or technology of the company(ies) listed above: