High-throughput therapeutic drug monitoring (TDM) with LC-MS/MS using either manual sample preparation or fully automated on-line SPE

Many drugs have predefined therapeutic ranges (e.g. AGNP Guidelines for Psychopharmaceuticals). When the upper limits of these ranges are exceeded, there is no better chance of therapy-success, but more side-effects due to overdose.

For patients, drug concentrations in blood should be kept in these ranges, therefore therapeutic drug monitoring (TDM) is recommended. The methods used for TDM-analysis have to be reliable, fast and are ideally covering many different drugs.

RECIPE has developed two TDM Kit-Systems for LC-MS/MS that cover over 120 different drugs with just one analytical system. The MS9000 Kit-System offers manual sample preparation while the MS9050 Kit-System is working with fully automated sample preparation with no need for a liquid handling system. Both systems need only one analytical column and the same mobile phases for all drug-classes.

For accurate and precise quantitation these complete kits 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. For analysis of each drug-class separate add-on sets are available.

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 so far enable the fast, easy and reliable determination of 14 Tricyclic Antidepressants, 35 Benzodiazepines, 27 Antiepileptics and 26 Antidepressants in serum or plasma.