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Parameter Set Neuroleptics 1/EXTENDED - LC-MS/MS

Order No.: 92912/XT
Parameters:
9-OH-Risperidone, Aripiprazole, Clozapine, Dehydroaripiprazole, Haloperidol, N-Desmethylclozapine, N-Desmethylolanzapine, Norquetiapine, Olanzapine, Quetiapine, Risperidone

Encompasses 11 analytes
3PLUS1® Multilevel Calibrator Set and MassCheck® controls
Part of the continuously extended MassTox® TDM Series A

Assay validated according to IVDR (=> Declaration of Conformity)

main product photo

Aripiprazole

Dehydroaripiprazole

Clozapine

N-Desmethylclozapine

Haloperidol

Olanzapine

N-Desmethylolanzapine

Quetiapine

Norquetiapine

Risperidone

9-OH-Risperidone

Clinical relevance

This parameter set allows the quantitative determination of aripiprazole, dehydroaripiprazole, clozapine, desmethylclozapine, haloperidol, quetiapine, norquetiapine, risperidone and 9-OH-risperidone in human serum or plasma samples as well as olanzapine and N-desmethylolanzapine in human EDTA plasma samples via liquid chromatography mass spectrometry (LC-MS/MS).

It is intended as a therapeutic drug monitoring test, medically indicated for patients treated with one or more of the neuroleptic drugs listed above.

 

MassTox® TDM Series A

The MassTox® TDM Series A is a modular system that enables the determination of 200 analytes without changing column or mobile phases, thereby minimising the workload in the laboratory.
It consists of 3 parts:
• MassTox® TDM Basic Kit A
• Specific MassTox® TDM Parameter Set (13 different parameter sets available)
• Analytical column MassTox® TDM MasterColumn® A

More information about MassTox® TDM Series A

 

MassSTAR

For this parameter set a CE-IVD compliant workflow method is also available using the MassSTAR to automate the sample preparation.

More information about MassSTAR

More Information
Method of Analysis LC-MS/MS
Please note The information listed here, including the sample preparation, is not sufficient for using the product. Please read the information provided in the instruction manual, which includes detailed information on limitations associated with the use of the product in line with its intended purpose. Detailed performance evaluation data for this assay can be found in the appendix of the instruction manual.
Lower and Upper Limit of Quantitation

Aripiprazole: 2.83 – 1350 µg/l
Clozapine: 22.0 – 540 µg/l
Haloperidol: 0.500 – 60.0 µg/l
Olanzapine: 3.00 – 300 µg/l
Quetiapine: 1.88 – 1200 µg/l
Risperidone: 1.20 – 60.0 µg/l

For the values of all analytes please refer to the instruction manual.

Different systems might show different performance data.
Specimen Serum/Plasma – For olanzapine and N-desmethylolanzapine only EDTA-Plasma
Sample Preparation

The information on the sample preparation presented here is not sufficient for use in the laboratory. For a detailed step by step description, please refer to the instruction manual.

  • Reconstitute the Internal Standard Mix.
  • Add 800 μl Internal Standard Mix to 12 ml Precipitation Reagent (= mixture A).
  • Pipette 50 μl sample/calibrator/MassCheck® control into a 1.5 ml reaction vial.
  • Add 25 μl Extraction Buffer, mix briefly (vortex) and incubate 2 min.
  • Add 250 μl of mixture A, mix 30 s (vortex) and centrifuge 5 min.
  • Dilute the supernatant with Dilution Buffer (depending on instrument sensitivity) and inject ≤ 20 µl into LC-MS/MS system.
Run Time 3.2 min
Injection Volume ≤ 20 µl (mass spectrometer dependent)
Flow Rate 0.6 ml/min
Column Temperature +20 to +25 °C
Gradient binary
Ionisation ESI positive
MS/MS Mode MRM
Parameters 9-OH-Risperidone, Aripiprazole, Clozapine, Dehydroaripiprazole, Haloperidol, N-Desmethylclozapine, N-Desmethylolanzapine, Norquetiapine, Olanzapine, Quetiapine, Risperidone

92912/XT MassTox® TDM Parameter Set Neuroleptics 1/EXTENDED

Order No. MassTox® TDM Basic Kit A
92111/200 Basic Kit A for 200 tests
92111/1000 Basic Kit A for 1000 tests

 

Order No. MassTox® TDM Basic Kit A (Quantities in kit for 200 tests)
92001 Mobile Phase 1, 1000 ml (1x)
92002 Mobile Phase 2, 1000 ml (1x)
92003 Precipitation Reagent, 50 ml (1x)
92005 Extraction Buffer, 5 ml (1x)
92007 Dilution Buffer 1, 50 ml (1x)
92008 Dilution Buffer 2, 50 ml (1x)
92009 Rinsing Solution, 1000 ml (1x)
33006 Reaction Vials, transparent, 1.5 ml, 100 pcs. (2x)

 

92912/XT MassTox® TDM Parameter Set Neuroleptics 1/EXTENDED components
92028/XT 3PLUS1® Multilevel Plasma Calibrator Set Neuroleptics 1/EXTENDED (lyoph.), 4 x 1 ml
0211/XT MassCheck® Neuroleptics 1/EXTENDED Plasma Control, Level I (lyoph.), 5 x 1 ml
0212/XT MassCheck® Neuroleptics 1/EXTENDED Plasma Control, Level II (lyoph.), 5 x 1 ml
92046/AN1/XT Internal Standard Set Antidepressants 1/EXTENDED and Neuroleptics 1/EXTENDED, constisting of:
Internal Standard Mix, 4 x 1 ml (lyoph.)
Reconstitution Buffer, 5 ml

 

Order No. Required components (not included in the kit or the parameter set)
92110 MassTox® TDM MasterColumn® A, equilibrated, with test chromatogram, 1 pc.
92015/N1/XT Tuning Mix Neuroleptics 1/EXTENDED (Analytes and Internal Standards), 1 ml

 

Order No. General lab equipment (non-CE/IVD products)
15010 PEEK Prefilter Housing, 1 pc.
15011 PEEK-encased Prefilter, 2 µm, 5 pcs.
15070 Stainless Steel Prefilter Housing, 1 pc.
15071 Stainless Steel Prefilter, 0.5 μm, 5 pcs.
33006 Reaction Vials, transparent, 1.5 ml, 100 pcs.
J0505 Micro-inserts for Autosampler Vials, clear glass, 100 pcs.
The following components are included in the kit:
  1. 92028XT LCMS TDM Series A 3PLUS1 calibrator neuroleptics 1_XT
    3PLUS1® Multilevel Plasma Calibrator Set Neuroleptics 1/ EXTENDED
    Order no.: 92028/XT
    MassTox® TDM Series A Neuroleptics 1/EXTENDED in Serum/Plasma – LC-MS/MS
    Details
  2. 0210XT 0211XT 0212XT TDM Series A contols neuroleptics1_XT
    MassCheck® Neuroleptics 1/EXTENDED Plasma Controls
    Order no.: 0210/XT; 0211/XT; 0212/XT
    MassTox® TDM Series A Neuroleptics 1/EXTENDED in Serum/Plasma – LC-MS/MS
    Details
  3. 92046AN1XT 92004AN1XT TDM Series A IS
    Internal Standard Set Antidepressants 1/EXTENDED and Neuroleptics 1/EXTENDED
    Order no.: 92046/AN1/XT

    Component of the Parameter Sets Antidepressants 1/EXTENDED and Neuroleptics 1/EXTENDED, available separately

    Details
The following products are not included in the kit but are required for the application of the method:
  1. 92110 TDM Series A Master Column
    MassTox® TDM MasterColumn® A
    Order no.: 92110

    Analytical column for MassTox® TDM Series A - LC-MS/MS

    Details
  2. 92015N1XT TDM Series A tuning mix
    Tuning Mix Neuroleptics 1/EXTENDED
    Order no.: 92015/N1/XT
    Tuning Mix for the Parameter Set Neuroleptics 1/EXTENDED - LC-MS/MS
    Details
  3. 92111 LCMS TDM Series A Basic Kit
    Basic Kit A for 200 Tests - LC-MS/MS
    Order no.: 92111/200

    Part of the MassTox® TDM Series A
    Modular system for therapeutic drug monitoring
    Provides all components required for sample prep and all mobile phases

    Validated according to IVDR

    Details
  4. 92111 LCMS TDM Series A Basic Kit
    Basic Kit A for 1000 Tests - LC-MS/MS
    Order no.: 92111/1000

    Part of the MassTox® TDM Series A
    Modular system for therapeutic drug monitoring
    Provides all components required for sample prep and all mobile phases

    Validated according to IVDR

    Details
  1. 92028XT LCMS TDM Series A 3PLUS1 calibrator neuroleptics 1_XT
    3PLUS1® Multilevel Plasma Calibrator Set Neuroleptics 1/ EXTENDED
    Order no.: 92028/XT
    MassTox® TDM Series A Neuroleptics 1/EXTENDED in Serum/Plasma – LC-MS/MS
    Details
  1. 0210XT 0211XT 0212XT TDM Series A contols neuroleptics1_XT
    MassCheck® Neuroleptics 1/EXTENDED Plasma Controls
    Order no.: 0210/XT; 0211/XT; 0212/XT
    MassTox® TDM Series A Neuroleptics 1/EXTENDED in Serum/Plasma – LC-MS/MS
    Details
  1. PEEK Prefilter Housing
    PEEK Prefilter Housing
    Order no.: 15010
    Details
  2. PEEK-encased Prefilter, 2 µm
    PEEK-encased Prefilter, 2 µm
    Order no.: 15011
    Details
  3. Reaction Vials, transparent, 1.5 ml
    Reaction Vials, transparent, 1.5 ml
    Order no.: 33006
    Details
  4. 15070 15071 Prefilter and Housing
    Stainless Steel Prefilter Housing
    Order no.: 15070
    Details
  5. Stainless Steel Prefilter - 0.5 µm
    Stainless Steel Prefilter - 0.5 µm
    Order no.: 15071
    Details
  6. Micro-inserts for Autosampler Vials, clear glass
    Micro-inserts for Autosampler Vials, clear glass
    Order no.: J0505
    Details
As a customer please login or register to gain full access.

Aripiprazole

Dehydroaripiprazole

Clozapine

N-Desmethylclozapine

Haloperidol

Olanzapine

N-Desmethylolanzapine

Quetiapine

Norquetiapine

Risperidone

9-OH-Risperidone

Clinical relevance

This parameter set allows the quantitative determination of aripiprazole, dehydroaripiprazole, clozapine, desmethylclozapine, haloperidol, quetiapine, norquetiapine, risperidone and 9-OH-risperidone in human serum or plasma samples as well as olanzapine and N-desmethylolanzapine in human EDTA plasma samples via liquid chromatography mass spectrometry (LC-MS/MS).

It is intended as a therapeutic drug monitoring test, medically indicated for patients treated with one or more of the neuroleptic drugs listed above.

 

MassTox® TDM Series A

The MassTox® TDM Series A is a modular system that enables the determination of 200 analytes without changing column or mobile phases, thereby minimising the workload in the laboratory.
It consists of 3 parts:
• MassTox® TDM Basic Kit A
• Specific MassTox® TDM Parameter Set (13 different parameter sets available)
• Analytical column MassTox® TDM MasterColumn® A

More information about MassTox® TDM Series A

 

MassSTAR

For this parameter set a CE-IVD compliant workflow method is also available using the MassSTAR to automate the sample preparation.

More information about MassSTAR

More Information
Method of Analysis LC-MS/MS
Please note The information listed here, including the sample preparation, is not sufficient for using the product. Please read the information provided in the instruction manual, which includes detailed information on limitations associated with the use of the product in line with its intended purpose. Detailed performance evaluation data for this assay can be found in the appendix of the instruction manual.
Lower and Upper Limit of Quantitation

Aripiprazole: 2.83 – 1350 µg/l
Clozapine: 22.0 – 540 µg/l
Haloperidol: 0.500 – 60.0 µg/l
Olanzapine: 3.00 – 300 µg/l
Quetiapine: 1.88 – 1200 µg/l
Risperidone: 1.20 – 60.0 µg/l

For the values of all analytes please refer to the instruction manual.

Different systems might show different performance data.
Specimen Serum/Plasma – For olanzapine and N-desmethylolanzapine only EDTA-Plasma
Sample Preparation

The information on the sample preparation presented here is not sufficient for use in the laboratory. For a detailed step by step description, please refer to the instruction manual.

  • Reconstitute the Internal Standard Mix.
  • Add 800 μl Internal Standard Mix to 12 ml Precipitation Reagent (= mixture A).
  • Pipette 50 μl sample/calibrator/MassCheck® control into a 1.5 ml reaction vial.
  • Add 25 μl Extraction Buffer, mix briefly (vortex) and incubate 2 min.
  • Add 250 μl of mixture A, mix 30 s (vortex) and centrifuge 5 min.
  • Dilute the supernatant with Dilution Buffer (depending on instrument sensitivity) and inject ≤ 20 µl into LC-MS/MS system.
Run Time 3.2 min
Injection Volume ≤ 20 µl (mass spectrometer dependent)
Flow Rate 0.6 ml/min
Column Temperature +20 to +25 °C
Gradient binary
Ionisation ESI positive
MS/MS Mode MRM
Parameters 9-OH-Risperidone, Aripiprazole, Clozapine, Dehydroaripiprazole, Haloperidol, N-Desmethylclozapine, N-Desmethylolanzapine, Norquetiapine, Olanzapine, Quetiapine, Risperidone

92912/XT MassTox® TDM Parameter Set Neuroleptics 1/EXTENDED

Order No. MassTox® TDM Basic Kit A
92111/200 Basic Kit A for 200 tests
92111/1000 Basic Kit A for 1000 tests

 

Order No. MassTox® TDM Basic Kit A (Quantities in kit for 200 tests)
92001 Mobile Phase 1, 1000 ml (1x)
92002 Mobile Phase 2, 1000 ml (1x)
92003 Precipitation Reagent, 50 ml (1x)
92005 Extraction Buffer, 5 ml (1x)
92007 Dilution Buffer 1, 50 ml (1x)
92008 Dilution Buffer 2, 50 ml (1x)
92009 Rinsing Solution, 1000 ml (1x)
33006 Reaction Vials, transparent, 1.5 ml, 100 pcs. (2x)

 

92912/XT MassTox® TDM Parameter Set Neuroleptics 1/EXTENDED components
92028/XT 3PLUS1® Multilevel Plasma Calibrator Set Neuroleptics 1/EXTENDED (lyoph.), 4 x 1 ml
0211/XT MassCheck® Neuroleptics 1/EXTENDED Plasma Control, Level I (lyoph.), 5 x 1 ml
0212/XT MassCheck® Neuroleptics 1/EXTENDED Plasma Control, Level II (lyoph.), 5 x 1 ml
92046/AN1/XT Internal Standard Set Antidepressants 1/EXTENDED and Neuroleptics 1/EXTENDED, constisting of:
Internal Standard Mix, 4 x 1 ml (lyoph.)
Reconstitution Buffer, 5 ml

 

Order No. Required components (not included in the kit or the parameter set)
92110 MassTox® TDM MasterColumn® A, equilibrated, with test chromatogram, 1 pc.
92015/N1/XT Tuning Mix Neuroleptics 1/EXTENDED (Analytes and Internal Standards), 1 ml

 

Order No. General lab equipment (non-CE/IVD products)
15010 PEEK Prefilter Housing, 1 pc.
15011 PEEK-encased Prefilter, 2 µm, 5 pcs.
15070 Stainless Steel Prefilter Housing, 1 pc.
15071 Stainless Steel Prefilter, 0.5 μm, 5 pcs.
33006 Reaction Vials, transparent, 1.5 ml, 100 pcs.
J0505 Micro-inserts for Autosampler Vials, clear glass, 100 pcs.
The following components are included in the kit:
  1. 92028XT LCMS TDM Series A 3PLUS1 calibrator neuroleptics 1_XT
    3PLUS1® Multilevel Plasma Calibrator Set Neuroleptics 1/ EXTENDED
    Order no.: 92028/XT
    MassTox® TDM Series A Neuroleptics 1/EXTENDED in Serum/Plasma – LC-MS/MS
    Details
  2. 0210XT 0211XT 0212XT TDM Series A contols neuroleptics1_XT
    MassCheck® Neuroleptics 1/EXTENDED Plasma Controls
    Order no.: 0210/XT; 0211/XT; 0212/XT
    MassTox® TDM Series A Neuroleptics 1/EXTENDED in Serum/Plasma – LC-MS/MS
    Details
  3. 92046AN1XT 92004AN1XT TDM Series A IS
    Internal Standard Set Antidepressants 1/EXTENDED and Neuroleptics 1/EXTENDED
    Order no.: 92046/AN1/XT

    Component of the Parameter Sets Antidepressants 1/EXTENDED and Neuroleptics 1/EXTENDED, available separately

    Details
The following products are not included in the kit but are required for the application of the method:
  1. 92110 TDM Series A Master Column
    MassTox® TDM MasterColumn® A
    Order no.: 92110

    Analytical column for MassTox® TDM Series A - LC-MS/MS

    Details
  2. 92015N1XT TDM Series A tuning mix
    Tuning Mix Neuroleptics 1/EXTENDED
    Order no.: 92015/N1/XT
    Tuning Mix for the Parameter Set Neuroleptics 1/EXTENDED - LC-MS/MS
    Details
  3. 92111 LCMS TDM Series A Basic Kit
    Basic Kit A for 200 Tests - LC-MS/MS
    Order no.: 92111/200

    Part of the MassTox® TDM Series A
    Modular system for therapeutic drug monitoring
    Provides all components required for sample prep and all mobile phases

    Validated according to IVDR

    Details
  4. 92111 LCMS TDM Series A Basic Kit
    Basic Kit A for 1000 Tests - LC-MS/MS
    Order no.: 92111/1000

    Part of the MassTox® TDM Series A
    Modular system for therapeutic drug monitoring
    Provides all components required for sample prep and all mobile phases

    Validated according to IVDR

    Details
  1. 92028XT LCMS TDM Series A 3PLUS1 calibrator neuroleptics 1_XT
    3PLUS1® Multilevel Plasma Calibrator Set Neuroleptics 1/ EXTENDED
    Order no.: 92028/XT
    MassTox® TDM Series A Neuroleptics 1/EXTENDED in Serum/Plasma – LC-MS/MS
    Details
  1. 0210XT 0211XT 0212XT TDM Series A contols neuroleptics1_XT
    MassCheck® Neuroleptics 1/EXTENDED Plasma Controls
    Order no.: 0210/XT; 0211/XT; 0212/XT
    MassTox® TDM Series A Neuroleptics 1/EXTENDED in Serum/Plasma – LC-MS/MS
    Details
  1. PEEK Prefilter Housing
    PEEK Prefilter Housing
    Order no.: 15010
    Details
  2. PEEK-encased Prefilter, 2 µm
    PEEK-encased Prefilter, 2 µm
    Order no.: 15011
    Details
  3. Reaction Vials, transparent, 1.5 ml
    Reaction Vials, transparent, 1.5 ml
    Order no.: 33006
    Details
  4. 15070 15071 Prefilter and Housing
    Stainless Steel Prefilter Housing
    Order no.: 15070
    Details
  5. Stainless Steel Prefilter - 0.5 µm
    Stainless Steel Prefilter - 0.5 µm
    Order no.: 15071
    Details
  6. Micro-inserts for Autosampler Vials, clear glass
    Micro-inserts for Autosampler Vials, clear glass
    Order no.: J0505
    Details
As a customer please login or register to gain full access.