MSACL 2016 EU Abstract

A High-Throughput Solution for Therapeutic Drug Monitoring (TDM) with LC-MS/MS – 132 Drugs on One Column

Katharina Kern (Presenter)
RECIPE Chemicals + Instruments GmbH

Bio: I studied Applied Chemistry at the University of Applied Sciences in Nürnberg (Georg-Simon-Ohm) and achieved my Diploma degree in 2009. After my studies, I started working for a privately owned lab in Munich, developing GC-MS/MS and LC-MS/MS methods for small endogenous molecules, to be used in big clinical studies. Since 2014 I am part of the R&D group at RECIPE Chemicals + Instruments GmbH in Munich. As Project Manager for Therapeutic Drug Monitoring with LC-MS/MS, I am responsible for further development and validation of the TDM Kit-Systems.

Authorship: Katharina Kern (1), Johannes Engl (1), Norbert Dirsch (1)
(1) RECIPE Chemicals + Instruments GmbH

Short Abstract

For accurate, sensitive and fast Therapeutic Drug Monitoring (TDM) in clinical routine analysis, RECIPE has developed its ClinMass® TDM Kit-systems MS9000 and MS9050. Each system works with just one analytical column and the same solvents for all analytes, so high-throughput with no change in hardware between methods can be realized. The MS9000 Kit-system offers a fast sample preparation technique, the MS9050 Kit-system is working with fully automated sample preparation without the need of a liquid handling system. Both Kit-systems show outstanding validation results for Tricyclic Antidepressants, Antiepileptics, Neuroleptics, Antidepressants, Benzodiazepines and Antimycotics with more drug classes in progress.

Long Abstract

Therapeutic Drug Monitoring (TDM) is recommended for many drugs to keep patients’ blood concentrations in the predefined therapeutic ranges (e.g. AGNP Guidelines for Psychopharmaka). While there is no therapeutic effect when the concentrations are below the lower limits of these ranges, exceeding the upper limits can lead to serious side effects.

As the number of drugs with TDM-recommendation is increasing, reliable and fast multi-analyte methods are in demand.

RECIPE has developed two TDM Kit-Systems for LC-MS/MS that cover 132 different drugs with just one analytical set-up. The MS9000 Kit-System offers a fast and simple manual sample preparation method while the MS9050 Kit-System can be fully automated using a regular autosampler (injection of pure serum/plasma onto a SPE-column). Several Add-On Sets for analysis of the different drug classes are available.

For accurate and precise quantitation, these Add-On Sets include serum multi-level calibrators (4 levels) and serum multi-level controls (2 levels) for quality assurance. Matrix effects are compensated using stable isotope labeled internal standards.

The lower and upper limits of quantitation (LLoQ, ULoQ) were found to be suitable for measurement of all native samples with the need of TDM. The coefficients of variation for the intraassay precision and for interassay precision were found to be < 15 %.

RECIPE’s fully validated and CE IVD certified ClinMass® TDM Kit-Systems combined with the ClinMass® Add-On Sets enable the fast, easy and reliable determination of 12 Tricyclic Antidepressants, 34 Benzodiazepines, 27 Antiepileptics, 26 Antidepressants, 28 Neuroleptics and 5 Antimycotics in serum or plasma (with more Add-On Sets to come up soon).


References & Acknowledgements:


Financial Disclosure

DescriptionY/NSource
Grantsno
SalaryyesRECIPE Chemicals + Instruments GmbH
Board Memberno
Stockno
Expensesno

IP Royalty: no

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

yes