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Therapeutic Drug Monitoring (TDM)

[Therapeutic Drug Monitoring (TDM)]

EPTIS factsheet 187843 | Last revision 2024-05-22 | URL: https://www.eptis.bam.de/pts187843 https://www.eptis.bam.de/pts187843

PT provider
PT provider Weqas Weqas
Based in United Kingdom
Remarks Drugs with a narrow Therapeutic index (difference between therapeutic concentration and toxic concentration) need to be monitored and controlled, as levels too high or low in the serum can result in adverse effects associated with toxic or fatal outcomes. The indications for drug monitoring have widened to include efficacy, compliance, drug-drug interactions, toxicity avoidance, and therapy cessation monitoring. These include certain antibiotics, antiepileptic drugs, digoxin, psychiatrics, and immunosuppressant drugs. TDM are most commonly tested with serum or plasma using commercially available immunoassays. While convenient and cost-effective, some assay interferences have been observed due to cross-reactivity with the drug’s metabolites, and in some cases, endogenous compounds or drugs with similar structures. Separate samples are provided in Whole Blood for the Immunosuppressant drugs: Ciclosporin, Sirolimus and Tacrolimus. Three liquid human serum samples and three whole blood samples are distributed monthly, with a minimum of 36 samples of each type distributed over the year covering the therapeutic and/ or toxic range. The base material is “off the clot” sterile human serum or whole blood, tested negative for HIV, Hep B and C at donor level. Key Features: - Stable liquid human serum samples or whole blood requiring no pre-analytical preparation. - Linear panel with known traceable “gravimetric, weighed in” concentration of drug. - Programme assesses both laboratory and method performance, including, sensitivity, specificity, linearity (recovery to gravimetric), bias, within and between batch imprecision. - Clinically relevant concentration range at therapeutic and toxic concentrations. For more information: https://www.weqas.com/services/eqa/tdm/ or contact@weqas.com
Product groups Health care / medical devices
Testing fields Medical analysis
Technical details
Test item Tested property Testing method
Off the clot human serum and whole blood Amikacin Routine testing methods (recommended)
Carbamazapine Routine testing methods (recommended)
Digoxin Routine testing methods (recommended)
Gentamicin Routine testing methods (recommended)
Lamotrigine Routine testing methods (recommended)
Lithium Routine testing methods (recommended)
Methotrexate Routine testing methods (recommended)
Phenobarbital Routine testing methods (recommended)
Phenytoin Routine testing methods (recommended)
Teicoplanin Routine testing methods (recommended)
Theophylline Routine testing methods (recommended)
Tobramycin Routine testing methods (recommended)
Valproic acid Routine testing methods (recommended)
Vancomycin Routine testing methods (recommended)
Ciclosporin Routine testing methods (recommended)
Sirolimus Routine testing methods (recommended)
Tacrolimus Routine testing methods (recommended)
Aims of the PT scheme
Target group of participants Programme assesses both laboratory and method performance, including, sensitivity, specificity, linearity (recovery to gravimetric), bias, within and between batch imprecision.
Linked to specific legislation / standards Accreditation by UKAS based on ISO/IEC 17043.
Additional, subsidiary aims validation of testing methods
Number of participants
Accredited or otherwise reviewed by a 3rd party

Accredited by UKAS on the basis of ISO/IEC 17043 for part of the parameters

Operation is commissioned / requested by
Fees and frequency
Participation fee https://www.weqas.com/participantzone/subscription-charges/
Regularly operated Yes (Frequency: Monthly. Samples: 3 x 1.0mL. )
Year of first operation 2013
Contact details of the PT provider
Provider Contact person
Unit 6, Parc Ty Glas
CF14 5DU Cardiff
United Kingdom

Phone: 44 (0) 2920 314750
Web: http://www.weqas.com http://www.weqas.com
Laura Lloyd-Lewis
Phone: 44 (0) 29218 32884
Email: laura.lloyd-lewis@wales.nhs.uk laura.lloyd-lewis@wales.nhs.uk
If you find any mistakes please contact the responsible EPTIS coordinator in United Kingdom, Mr Savvas Xystouris. Mr Savvas Xystouris.
Any questions or problems? Please contact us at eptis@bam.de.
Application version: 1.23-SNAPSHOT.20230502124635-7925ae379a631fc1ececff45d2921c8db38877d5