Parameter Set Neuroleptics 1/EXTENDED - LC-MS/MS
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)
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
Detailed performance evaluation data can be found in Appendices II and III of the instruction manual.
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 can be found in Appendices II and III of the instruction manual. |
Lower and Upper Limit of Quantitation | Aripiprazole: 2.83 – 1350 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.
|
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. | Lab equipment |
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. |
-
3PLUS1® Multilevel Plasma Calibrator Set Neuroleptics 1/ EXTENDEDOrder no.: 92028/XTMassTox® TDM Series A Neuroleptics 1/EXTENDED in Serum/Plasma – LC-MS/MS
-
MassCheck® Neuroleptics 1/EXTENDED Plasma ControlsOrder no.: 0210/XT; 0211/XT; 0212/XTMassTox® TDM Series A Neuroleptics 1/EXTENDED in Serum/Plasma – LC-MS/MS
-
Internal Standard Set Antidepressants 1/EXTENDED and Neuroleptics 1/EXTENDEDOrder no.: 92046/AN1/XT
Component of the Parameter Sets Antidepressants 1/EXTENDED and Neuroleptics 1/EXTENDED, available separately
-
MassTox® TDM MasterColumn® AOrder no.: 92110
Analytical column for MassTox® TDM Series A - LC-MS/MS
-
Tuning Mix Neuroleptics 1/EXTENDEDOrder no.: 92015/N1/XTTuning Mix for the Parameter Set Neuroleptics 1/EXTENDED - LC-MS/MS
-
Basic Kit A for 200 Tests - LC-MS/MSOrder 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 phasesValidated according to IVDR
-
Basic Kit A for 1000 Tests - LC-MS/MSOrder 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 phasesValidated according to IVDR
-
3PLUS1® Multilevel Plasma Calibrator Set Neuroleptics 1/ EXTENDEDOrder no.: 92028/XTMassTox® TDM Series A Neuroleptics 1/EXTENDED in Serum/Plasma – LC-MS/MS
-
MassCheck® Neuroleptics 1/EXTENDED Plasma ControlsOrder no.: 0210/XT; 0211/XT; 0212/XTMassTox® TDM Series A Neuroleptics 1/EXTENDED in Serum/Plasma – LC-MS/MS
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
Detailed performance evaluation data can be found in Appendices II and III of the instruction manual.
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 can be found in Appendices II and III of the instruction manual. |
Lower and Upper Limit of Quantitation | Aripiprazole: 2.83 – 1350 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.
|
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. | Lab equipment |
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. |
-
3PLUS1® Multilevel Plasma Calibrator Set Neuroleptics 1/ EXTENDEDOrder no.: 92028/XTMassTox® TDM Series A Neuroleptics 1/EXTENDED in Serum/Plasma – LC-MS/MS
-
MassCheck® Neuroleptics 1/EXTENDED Plasma ControlsOrder no.: 0210/XT; 0211/XT; 0212/XTMassTox® TDM Series A Neuroleptics 1/EXTENDED in Serum/Plasma – LC-MS/MS
-
Internal Standard Set Antidepressants 1/EXTENDED and Neuroleptics 1/EXTENDEDOrder no.: 92046/AN1/XT
Component of the Parameter Sets Antidepressants 1/EXTENDED and Neuroleptics 1/EXTENDED, available separately
-
MassTox® TDM MasterColumn® AOrder no.: 92110
Analytical column for MassTox® TDM Series A - LC-MS/MS
-
Tuning Mix Neuroleptics 1/EXTENDEDOrder no.: 92015/N1/XTTuning Mix for the Parameter Set Neuroleptics 1/EXTENDED - LC-MS/MS
-
Basic Kit A for 200 Tests - LC-MS/MSOrder 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 phasesValidated according to IVDR
-
Basic Kit A for 1000 Tests - LC-MS/MSOrder 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 phasesValidated according to IVDR
-
3PLUS1® Multilevel Plasma Calibrator Set Neuroleptics 1/ EXTENDEDOrder no.: 92028/XTMassTox® TDM Series A Neuroleptics 1/EXTENDED in Serum/Plasma – LC-MS/MS
-
MassCheck® Neuroleptics 1/EXTENDED Plasma ControlsOrder no.: 0210/XT; 0211/XT; 0212/XTMassTox® TDM Series A Neuroleptics 1/EXTENDED in Serum/Plasma – LC-MS/MS