MSACL 2019 EU

LC-MS in Clinical Research – Be Sure of Performance, Today and Tomorrow
Claudio DeNardi, Thermo Fisher Scientific, EU

The superior selectivity, specificity, robustness, and sensitivity offered by liquid-chromatography (LC) - mass spectrometry (MS) has made this technique one of the most advantageous in the field, here we highlight our comprehensive portfolio of LC-MS platforms and novel applications.

Increased Confidence in Data with High Resolution Accurate Mass: Screening and Quantifying Fentanyls and NPS
Speaker: Simon Hudson, Technical Director, LGC; Fordham, England, UK

Trying to stay one-step ahead – how High-Resolution Accurate Mass LCMS has enabled early detection of fentanyl analogues (including carfentanil) and synthetic cannabinoids in the UK

One of the biggest challenges facing forensic toxicology is to ensure that detection methodologies keep up with new drugs, such as New Psychoactive Substances (NPS) that are continuously entering the (black) marketplace. High Resolution Accurate Mass based LCMS allows the analyst to rapidly respond to new drug threats and to even monitor for predicted new designer compounds whilst still covering all the existing drug threats.

Two screening workflows are described:

1. The detection of fentanyl analogues as part of a broad drug screen including the first detection of carfentanil in post mortem samples in the UK in February 2017
2. The continuing evolution and detection of synthetic cannabinoid receptor agonists (SCRAs) in the UK.

Precise Quantitative Serum LC-MS/MS Profiling: The Impact of Sample Preparation and Sample Source on Biomarker Discovery Studies
Alexander Boychenko, Thermo Fisher Scientific, Germering, Germany

Laboratory-Developed Mass Spectrometry testing vs Regulatory-Approved tests: Pros and Cons
Moderator: Torsten Binscheck-Domass, Lead Scientist, Clinical Mass Spectrometry, Thermo Fisher Scientific

Summary: Current LC-MS/MS methods often are Lab-Developed-Tests (LDT) whose development and implementation can be challenging for clinical laboratories. To establish accurate and reproducible MS-based LDTs, a significant level of expertise is required. In the end, MS-based LDTs should be fit-for-clinical purpose and behave consistently in time and space. As most MS-based LDTs are at best only partially automated, they encompass numerous manual steps.  The latter all contribute to measurement uncertainty, which might be reduced in case of full automation. For clinical applications, both regulatory-approved MS-based tests and MS-based LDTs should be compliant with ISO 15189, ISO 17511, the current IVD Directive 98/79/EC, and in the near future with the upcoming IVD 2017/746. Prof Dr. Christa Cobbaert will speak on the unmet clinical needs that drive medical test development, the necessity of metrological traceability of MS-based test results and a possible way out on how to fulfill the new clinical evidence requirements under the new IVDR. The challenges for both LDTs and regulatory-approved tests will be highlighted. Then representatives from Thermo Fisher Scientific will introduce a fully-automated, regulatory-approved approach to LC-MS/MS testing, the Cascadion SM Clinical Analyzer*. 

Part 1: Balancing the pros and cons of Mass Spec-based Lab-Developed-Tests as compared to Regulatory-Approved Tests under the new IVD Regulation 2017/746 in Europe
Prof. Dr. Christa Cobbaert, Head of Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, NE; also EC observer in EC IVD working group 8 under the Medical Device Coordination Group.

Part 2: Cascadion SM 25-Hydroxy Vitamin D* and Immunosuppressants Panel**—Assays on the Cascadion SM Clinical Analyzer*
Ville Rajala, Sr Product Manager, Clinical Mass Spectrometry, Thermo Fisher Scientific

* Cascadion SM Clinical Analyzer is IVD/CE marked but not 510(k)-cleared and not yet available for sale in the U.S. Availability of product in each country depends on local regulatory marketing authorization status.
** Immunosuppresants Panel for Cascadion SM Clinical Analyzer is in development. Only preliminary feasibility data will be introduced. Product is not IVD/CE marked or 510(k) cleared, and is not available for sale.