TDM 200 Kit System

Therapeutic Drug Monitoring (TDM) by LC-MS/MS

The RECIPE 200 Kit System opens a wide range of clinical relevant substances for a patient oriented Therapeutic Drug Management. Only one column to cover the most relevant drug classes.

One step sample preparation

TDM 200 Kit System

The TDM 200 Kit System offers the possibility to determine more than 150 different analytical parameters. All you need is our TDM Kit System with one analytical column, two mobile phases and the add- on sets.  The analytes are separated and determined by LC-MS/MS analysis. 

Your benefits

  • flexible expansion of the add-on sets
  • improves the individual therapeutic regimen for the patient
  • no new validation necessary
  • regular addition of new drug classes to adopt fast growing medical need

Components of the TDM 200 Kit Systems

1 Analytical Column

+

2 Mobile Phases

+

8 different Add-on Sets

Simplify your lab-routine

The TDM 200 Kit System is also available as  TDMi Kit solution with direct injection of matrix.

  • Direct injection of matrix
  • Retention times < 7 min.
  • Small sample volume needed < 20 μl

Available Analyte Panel

BZP

BZP – Benzodiazepines

Clinical Background

Benzodiazepines are a group of psychoactive drugs with a broad range of therapeutic effects. They act as anxiolytics, sedatives and anticonvulsants and belong to the most frequently prescribed drugs all over the world. Currently around 50 different benzodiazepines are globally marketed. The chemical structure the drugs differ in pharmacokinetics and metabolic properties. Long-term administration of benzodiazepines requires therapeutic drug monitoring (TDM).

Therapeutic drug monitoring (TDM) is the clinical laboratory practice to determine drug concentrations in blood to optimise a personalised pharmacotherapy, especially in indications with a small therapeutic range. Drug interactions, efficacy, toxicity avoidance and the surveillance of compliance are typical indications where TDM is requested. The RECIPE analytical method provides the reliable quantitation of 35 different benzodiazepines.

 

Analytes

Analytes 
3-HydroxybromazepamFlunitrazepam
7-AminoclonazepamFlurazepam
N-1-Desalkylflurazepam
7-AminoflunitrazepamLorazepam
7-AminonitrazepamLormetazepam
α-HydroxyalprazolamMedazepam
desmethyldiazepam, temazepam plus oxazepam
α-HydroxymidazolamMidazolam
α-HydroxytriazolamNitrazepam
AlprazolamNorclobazam (Desmethylclobazam)
BromazepamNordiazepam
(Nordazepam)
ChlordiazepoxideOxazepam
ClobazamPrazepam
ClonazepamTemazepam
DemoxepamTetrazepam
DesalkylflurazepamTrazodon
DesmethylflunitrazepamTriazolam
Diazepam plus
N-Desmethyldiazepam (Nordiazepam)
Zaleplon
EstazolamZolpidem
Zopiclon

chroma-benzodiazepine
Direct Injection

chroma-benzodiazepines

Ordering Information

Order No.


Description


Quantity


MS9000


ClinMass® TDM Platform for 400 assays


1 pce.


Kit Components (order no. MS9000):


MS9005


Autosampler Washing Solution


1000 ml


MS9007


Mobile Phase A


2 x MS9007 (2 x 1000 ml)


MS9008


Mobile Phase B


1000 ml


MS9020


Sample Preparation Vials


4 x MS9020 (4 x 100 pcs.)


MS9021


Precipitant P


2 x MS9021 (2 x 25 ml)


Start Accessories:


MS9030


Analytical Column with test chromatogram


1 pce.


MS9032


Prefilter


1 pce.


Accessories:


MS9022


Diluting Solution D


50 ml


MS9500


ClinMass® Add-on Set for Benzodiazepines in Serum / Plasma for 200 assays


1 pce.


Kit Components (order no. MS9500):


MS9512


Internal Standard IS, lyophil.


5 x 5 ml


MS6013


Serum Calibrator Set, lyophil. (Level 0 – 3)


4 x 1 x 1 ml


Manual


1 pce.


Start Accessories:


MS6015


Optimisation Mix 1 – 5, lyophil.


2 ml each


MS6019


ClinChek® Controls:


MS6082


Serum Control, lyophil., Level I, II


2 x 5 x 1 ml


Want to learn more?

BZP – Benzodiazepines in Serum/Plasma Technote
Download (PDF)

ADP

ADP – Antidepressants

Clinical background

Many adults are affected by major depressive disorders (MDD) at some point during their lifetime. Treatment for MDD is often started in a primary care setting, and patients generally receive drugs as the standard treatment. In addition to the classical tricyclic antidepressants (TCAs) a variety of newer antidepressants (ADP) is available for the treatment of MDD. These include selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs, NRIs) as well as tetracyclic antidepressants (TeCAs).

Therapeutic drug monitoring (TDM), i.e. the quantification of serum concentrations of medications for dose optimization, is required to ensure a patient-matched psychopharmacotherapy and to avoid side effects. Uncertain drug adherence, suboptimal tolerability, non-response at therapeutic doses, or pharmacokinetic drug-drug interactions are typical situations when measurement of medication concentrations is helpful.

Analytes

Analyten 
AgomelatinMilnacipran
AtomoxetinMirtazapin
BupropionMoclobemid
CitalopramNefazodon
ClomethiazolO-Desmethyltramadol
DesmethylcitalopramO-Desmethylvenlafaxin
DesmethylfluoxetinOpipramol
Desmethylmianserin Paroxetin
DesmethylmirtazapinReboxetin
DesmethylsertralinRitalinsäure
DosulepinSertralin
Duloxetinthreo-Dihydro-Bupropion
erythro-Dihydro-BupropionTianeptin
FluoxetinTramadol
FluvoxaminTranylcypromin
GuanfacinTrazodon
HydroxybupropionVenlafaxin
MethylphenidatVortioxetin
Mianserin

chroma-antidepressiva
Direct Injection
chroma-antidepressiva

Ordering Information

Order No.


Description


Quantity


MS9000


ClinMass® TDM Platform for 400 assays


1 pce.


Kit Components (order no. MS9000):


MS9005


Autosampler Washing Solution


1000 ml


MS9007


Mobile Phase A


2 x MS9007 (2 x 1000 ml)


MS9008


Mobile Phase B


1000 ml


MS9020


Sample Preparation Vials


4 x MS9020 (4 x 100 pcs.)


MS9021


Precipitant P


2 x MS9021 (2 x 25 ml)


Start Accessories:


MS9030


Analytical Column with test chromatogram


1 pce.


MS9032


Prefilter


1 pce.


Accessories:


MS9022


Diluting Solution D


50 ml


MS9400


ClinMass® Add-on Set for Antidepressants in Serum / Plasma for 200 assays


1 pce.


Kit Components (order no. MS9400):


MS9412


Internal Standard IS, lyophil.


5 x 5 ml


MS9413


Serum Calibrator Set, lyophil. (Level 0 – 3)


4 x 1 x 1 ml


Manual


1 pce.


Start Accessories:


MS9414


Optimisation Mix, lyophil.


2 x 2 ml


ClinChek® Controls:


MS9482


Serum Control, lyophil., Level I, II


2 x 5 x 1 ml


AED

AED – Antiepileptic Drugs

Clinical Background

Epilepsy is a chronic neurological disorder, characterised by recurrent epileptic seizures. The frequency and the rhythm of seizures are hardly predictable. Therefore, seizures are not only a considerable psychological and physical burden for the patient, they may also lead to grave and even life-threatening hurts (e.g. craniocerebral injuries in case of falls). Brain damages may result in case of a hypoxia. Today, a variety of antiepileptic drugs (AEDs) with different pharmacological properties is available.

Therapeutic drug monitoring (TDM) is the clinical laboratory practice to determine drug concentrations in blood to optimise a personalised pharmacotherapy, especially in indications with a small therapeutic range. Drug interactions, efficacy, toxicity avoidance and the surveillance of compliance are typical indications where TDM is requested. The RECIPE analytical method provides the reliable quantification of 27 AEDs.

Analytes

Analytes 
10-OH-CarbamazepinePerampanel
BrivaracetamPhenobarbital
CarbamazepinePhenytoin
Carbamazepine-diolPregabaline
Carbamazepine-epoxidePrimidone
EthosuximideRetigabine
FelbamateRufinamide
GabapentineStiripentol
LacosamideSulthiame
LamotrigineTiagabine
LevetiracetamTopiramate
N-DesmethylmethsuximideValproic Acid
OxcarbazepineZonisamide
Phenylethylmalonamide (PEMA)

chroma-antiepileptic
Direct Injection

 

 

chroma-antiepileptic

Ordering Information

Order No.


Description


Quantity


MS9000


ClinMass® TDM Platform for 400 assays


1 pce.


Kit Components (order no. MS9000):


MS9005


Autosampler Washing Solution


1000 ml


MS9007


Mobile Phase A


2 x MS9007 (2 x 1000 ml)


MS9008


Mobile Phase B


1000 ml


MS9020


Sample Preparation Vials


4 x MS9020 (4 x 100 pcs.)


MS9021


Precipitant P


2 x MS9021 (2 x 25 ml)


Start Accessories:


MS9030


Analytical Column with test chromatogram


1 pce.


MS9032


Prefilter


1 pce.


Accessories:


MS9022


Diluting Solution D


50 ml


MS9200


ClinMass® Add-on Set for Antiepileptic Drugs in Serum / Plasma for 200 assays


1 pce.


Kit Components (order no. MS9200):


MS9212


Internal Standard IS, lyophil.


5 x 5 ml


MS9213


Serum Calibrator Set, lyophil. (Level 0 – 3)


4 x 1 x 1 ml


Manual


1 pce.


Start Accessories:


MS9214


Optimisation Mix, lyophil.


5 x 2 ml


ClinChek® Controls:


MS9282


Serum Control, lyophil., Level I, II


2 x 5 x 1 ml


 

Want to learn more?

AED – Antiepileptic Drugs in Serum/Plasma
Download (PDF)

AMC

AMC – Antimycotics

Clinical Background

Invasive fungal infections, predominantly aspergillosis and candidiasis, are the most important causes of morbidity and mortality in immunocompromised patients. Primarily, patients with acute leukemia undergoing myelosuppressive chemotherapy and allogeneic stem cell transplant recipients are affected. Up to 60 % of patients with invasive aspergillosis, the most common invasive mycosis among patients with hematologic malignancies, may still die of their infection, once it has become clinically overt.

Antimycotics (antifungal drugs, antifungals) are a class of drugs that are used for the treatment and prophylaxis of fungal infections.

Therapeutic drug monitoring (TDM) is the clinical laboratory practice to determine drug concentrations in blood to optimise a personalised pharmacotherapy, especially in indications with a small therapeutic range. Drug interactions, efficacy, toxicity avoidance and the surveillance of compliance are typical indications where TDM is requested.

The RECIPE analytical method provides the reliable quantification of 11 antimycotics.

Analytes

Analytes 
5-FluorocytosineKetoconazole
Amphotericin BItraconazole
AnidulafunginOH-Itraconazole
FluconazolePosaconazole
IsavuconazoleVoriconazole

AMC Chromatogram
Direct Injection
Chromatogram Antimycotic online

Ordering Information

Order No.


Description


Quantity


MS9000


ClinMass® TDM Platform for 400 assays


1 pce.


Kit Components (order no. MS9000): 


MS9005


Autosampler Washing Solution


1000 ml


MS9007


Mobile Phase A


2 x MS9007 (2x 1000 ml)


MS9008


Mobile Phase B


1000 ml


MS9020


Sample Preparation Vials


4 x MS9020 (4 x 100 pcs.)


MS9021


Precipitant P


2 x MS9021 (2 x 25 ml)


Start Accessories: 


MS9030


Analytical Column with test chromatogram


1 pce.


MS9032


Prefilter


1 pce.


Accessories: 


MS9022


Diluting Solution D


50 ml


MS9600


ClinMass® Add-on Set for Antimycotics in Serum / Plasma for 200 assays


1 pce.


Kit Components (order no. MS9100):


MS9612


Internal Standard IS, lyophil.


5 x 5 ml


MS9613


Serum Calibrator Set, lyophil. (Level 0 – 3)


4 x 1 x 1 ml


 


Manual


 


Start Accessories: 


MS9614


Optimisation Mix, lyophil.


2 ml


ClinChek® Controls: 


MS9682


Serum Control, lyophil., Level I, II


2 x 5 x 1 ml


 

Want to learn more?

AMC – Antimycotics in Serum/Plasma
Download (PDF)

MPA

MPA – Mycophenolic Acid

Clinical background

Mycophenolic acid (MPA) is the active metabolite of the prodrug mycophenolate mofetil (MMF, proprietary names CellCept and Myfortic) and is used for the immunosuppressive therapy in patients who are undergoing solid organ transplantation. MPA is widely used along with other standard drug regimens such as with tacrolimus, cyclosporine and/or corticosteroids to ensure that graft rejection does not occur.

Following oral MMF administration, MPA is rapidly absorbed and distributed in blood and tissues. MPA peak concentrations usually are observed within an hour. In the liver MPA is metabolised whereby the phenolic glucuronide MPAG (mycophenolic acid glucuronide) forms the main fraction:

MMF → MPA → MPAG

MPAG is pharmacologically inactive. However, MPA may be reformed from MPAG by entero-hepatic recirculation (EHR). As a result secondary MPA plasma peaks are frequently observed (6-12h post oral dose) even after the absorption from the oral dose has ceased to exist.

The clinical pharmacokinetics of MPA are characterized by a high inter- and intraindividual variability. Reasons for interindividual pharmacokinetic variability include differences in albumin concentrations, bilirubin and hemoglobin concentrations, renal and hepatic function (impairment), co-administration of cyclosporine, comorbidities such as cystic fibrosis, body weight, exposure to concomitant medication, time after transplantation, gender, race, and genetic polymorphisms in drug-metabolising enzymes.

The administration of MMF therefore requires a therapeutic drug monitoring (TDM) in order to provide an optimal therapeutic efficacy, i.e. to maximise drug efficacy while minimising drug toxicity and is strongly recommended in pediatric transplantation patients.

Although a global consensus on TDM has not been established for MPA, there has been a suggestion of maintaining MPA threshold levels in a 12h dosing interval to achieve an AUC for MPA of approximately 30–60 mg × h/l for an effective prophylaxis. RECIPE´s analytical method ensures the quantification of MPA and MPAG and provides an adequate chromatographic separation of both analytes. Besides the monitoring of secondary MPA an adequate separation ensures to avoid false positive MPA values caused by ion-source fragmentation of MPAG.

Analytes

Analytes 
Mycophenolic acidMycophenolic acid glucuronide

chroma-mycophenolic

Ordering Information

Order No.


Description


Quantity


MS9000


ClinMass® TDM Platform for 400 assays


1 pce.


Kit Components (order no. MS9000):


MS9005


Autosampler Washing Solution


1000 ml


MS9007


Mobile Phase A


2 x MS9007 (2 x 1000 ml)


MS9008


Mobile Phase B


1000 ml


MS9020


Sample Preparation Vials


4 x MS9020 (4 x 100 pcs.)


MS9021


Precipitant P


2 x MS9021 (2 x 25 ml)


Start Accessories:


MS9030


Analytical Column


1 pce.


MS9032


Prefilter


1 pce.


Accessory:


MS9022


Diluting Solution D


50 ml


MS99100


ClinMass® Add-on Set for Mycophenolic Acid in Serum / Plasma for 200 assays


1 pce.


Kit Components (order no. MS99100):


MS99112


Internal Standard IS, lyophil.


5 x 5 ml


MS99113


Serum Calibrator Set, lyophil., Level 0 – 3


4 x 1 x 1 ml


MS9022


Diluting Solution D


2 x MS9022 (2 x 50 ml)


Start Accessories:


MS99114


Optimisation Mix, lyophil.


2 ml


ClinChek® Controls:


MS99183


Plasma Control, lyophil., Level I, II, III


3 x 3 x 1 ml


 

NLP

NLP – Neuroleptics

Clinical background

Neuroleptics belong to the class of psychoactive drugs and are administered in the therapy of psychoses, in particular the symptomatic treatment of schizophrenia. The longterm administration of neuroleptics gradually reduces schizophrenic reactions such us split personality, hallucinations, delusional ideas, and as a consequence the patient’s level of suffering is decreased.

Neuroleptics are classified in different substance groups such as phenothiazines, butyrophenones, dibenzazepines and so called “atypical” neuroleptics. All neuroleptics have in common that the acute onset effect correlates with the current blood-level concentration. Higher dosages lead to apathy and sleep, the acute intoxication (e.g. by suicidal intent) results in delirium, coma and even death due to circulatory failure and respiratory paralysis. Therapeutic drug monitoring (TDM) is recommended for treatment with neuroleptics.

TDM is the quantification of the drug concentration in serum. It is carried out in order to find the optimal drug level for the patient and thus to ensure the best psychoactive drug therapy for the patient with the lowest possible amount of side effects. Uncertain drug adherences, suboptimal tolerability, non-response at therapeutic doses, or pharmacokinetic drug-drug interactions are typical situations when measurement of medication concentrations is helpful. The RECIPE analytical method provides the reliable quantification of 28 different neuroleptics.

Analytes

Analytes 
AmisulprideOlanzapine
AripiprazolePaliperidone (9-OH-Risperidone)
ChlorpromazinePerazine
ChlorprothixenePipamperone
ClozapinePromethazine
Dehydro-AripiprazoleProthipendyl
DesmethylolanzapineQuetiapine
FlupentixolRisperidone
FluphenazineSertindole
HaloperidolSulpiride
LevomepromazineThioridazine
MelperoneZiprasidone
NorclozapineZotepine
NorquetiapineZuclopenthixol

 

chroma-neuroleptics
Direct Injection

chroma-neuroleptics

Ordering Information

Order No.


Description


Quantity


MS9000


ClinMass® TDM Platform for 400 assays


1 pce.


Kit Components (order no. MS9000): 


MS9005


Autosampler Washing Solution


1000 ml


MS9007


Mobile Phase A


2 x MS9007 (2x 1000 ml)


MS9008


Mobile Phase B


1000 ml


MS9020


Sample Preparation Vials


4 x MS9020 (4 x 100 pcs.)


MS9021


Precipitant P


2 x MS9021 (2 x 25 ml)


Start Accessories: 


MS9030


Analytical Column with test chromatogram


1 pce.


MS9032


Prefilter


1 pce.


Accessories: 


MS9022


Diluting Solution D


50 ml


MS9300


ClinMass® Add-on Set for Neuroleptics in Serum / Plasma for 200 assays


1 pce.


Kit Components (order no. MS9300):


MS9312


Internal Standard IS, lyophil.


5 x 5 ml


MS9313


Serum Calibrator Set, lyophil. (Level 0 – 3)


4 x 1 x 1 ml


 


Manual


 


Start Accessories: 


MS9314


Optimisation Mix, lyophil.


2 x 1 x 2 ml


ClinChek® Controls: 


MS9382


Serum Control, lyophil., Level I, II


2 x 5 x 1 ml




TCA

TCA – Tricyclic Antidepressants

Clinical background

Tricyclic antidepressants (TCAs) are a group of psychoactive drugs which are mainly used for the therapy of endogene depressions, anxiety and pain management. Their name is derived from a common chemical structure with a tripartite ring system. The following figure exemplifies the structure with the compounds amitryptiline, imipramine, doxepin and clomipramine.

TCAs are widely established compounds since the 1960s, however due to their side effects they have a narrow therapeutic range, which requires therapeutic drug monitoring (TDM). The consequences of overdosing may vary from mild agitation or drowsiness to delirium and coma resulting in death.

The drug monitoring is mainly performed from serum. Besides dosage optimisation, the monitoring is used for the verification of compliance as well as for the early detection of pharmacokinetic changes of the compound.

RECIPE’s analytical method provides the reliable quantification of 13 TCAs and two atypical neuroleptics and their metabolites.

Analytes

Analytes 
AmitriptylineNorclozapine
ClomipramineNordoxepin
ClozapineNormaprotiline
DesipramineNortrimipramine
DoxepinNortriptyline
ImipramineProtriptyline
MaprotilineTrimipramine
Norclomipramine

 

chroma-tricyclic-antidepressants
Direct Injection
chroma-tricyclic-antidepressants

Ordering Information

Order No.


Description


Quantity


MS9000


ClinMass® TDM Platform for 400 assays


1 pce.


Kit Components (order no. MS9000):


MS9005


Autosampler Washing Solution


1000 ml


MS9007


Mobile Phase A


2 x MS9007 (2 x 1000 ml)


MS9008


Mobile Phase B


1000 ml


MS9020


Sample Preparation Vials


4 x MS9020 (4 x 100 pcs.)


MS9021


Precipitant P


2 x MS9021 (2 x 25 ml)


Start Accessories:


MS9030


Analytical Column with test chromatogram


1 pce.


MS9032


Prefilter


1 pce.


Accessories:


MS9022


Diluting Solution D


50 ml


MS9100


ClinMass® Add-on Set for Tricyclic Antidepressants in Serum / Plasma for 200 assays


1 pce.


Kit Components (order no. MS9100):


MS9112


Internal Standard IS, lyophil.


5 x 5 ml


MS9113


Serum Calibrator Set, lyophil. (Level 0 – 3)


4 x 1 x 1 ml


Manual


1 pce.


Start Accessories:


MS9114


Optimisation Mix, lyophil.


2 x 2 ml


ClinChek® Controls:


MS9182


Serum Control, lyophil., Level I, II


2 x 5 x 1 ml


ISD

ISD – Immunosuppressants

Clinical background

Immunosuppressive drugs have an inhibitory effect on the immune system. They are used in organ transplantations with the aim of suppressing immune reactions of the recipient. Therefore a regular monitoring of the drug concentration in blood is necessary.

Common drug classes are the selective immunosuppressants sirolimus, everolimus and mycophenolic acid as well as the calcineurin inhibitors cyclosporine A and tacrolimus. All of those drugs have a narrow therapeutic range, so underdosing leads to rejection of the transplanted organ and overdosing to life-threatening, toxic side effects. By using the RECIPE TDM 200 Kit System for measuring immunosuppressant blood concentrations on a regular basis, the ideal target concentration of the drugs can be achieved. The Immunosuppressants Add-on Set includes the four most common drugs cyclosporine A, sirolimus, everolimus and tacrolimus.

Analytes

Analytes 
Cyclosporine ASirolimus
EverolimusTacrolimus

isd chromatogramm

Ordering Information

Order No.DescriptionQuantity
MS9000AClinMass® TDM Platform1 pce.
for 400 assays
Content:
Autosampler Washing Solution1 x MS9005
Mobile Phase A2 x MS9007
Mobile Phase B1 x MS9008
Sample Preparation Vials4 x MS9020
Precipitant P1 x MS1021
Separately available components:
MS9005Autosampler Washing Solution1000 ml
MS9007Mobile Phase A1000 ml
MS9008Mobile Phase B1000 ml
MS9020Sample Preparation Vials100 pcs.
MS1021Precipitant P80 ml
Start Accessories:
MS9030Analytical Column with test chromatogram1 pce.
MS9032Prefilter1 pce.
MS99200ClinMass® Add-on Set1 pce.
for Immunosuppressants in Whole Blood
for 200 assays
Content:
Internal Standard IS, lyophil.2 x MS1412
Whole Blood Calibrator Set, lyophil. (Level 0 – 6)1 x 9933
Manual
Separately available components:
MS1412Internal Standard IS, lyophil.3 ml
9028Whole Blood Calibrator, lyophil.2 x 2 ml
(additional level for order nos. 9033 and 9933)
9033Whole Blood Calibrator Set, lyophil. (Level 0 – 3)4 x 1 x 2 ml
9933Whole Blood Calibrator Set, lyophil. (Level 0 – 6)7 x 1 x 2 ml
Start Accessory:
MS1014Optimisation Mix 1, lyophil.2 ml
MS1115Optimisation Mix 2, lyophil.2 ml
ClinChek® Controls:
8830Whole Blood Control, lyophil.5 x 2 ml
Level I
8831Whole Blood Control, lyophil.5 x 2 ml
Level II
8832Whole Blood Control, lyophil.5 x 2 ml
Level III
8833Whole Blood Control, lyophil.3 x 2 x 2 ml
Level I, II, III
8903Whole Blood Control, lyophil.2 x 2 x 2 ml
Level IV, V