Parameter Set Antimycotic Drugs/EXTENDED - LC-MS/MS
Encompasses 11 analytes
3PLUS1® Multilevel Calibrator Set and MassCheck® controls
Part of the continuously extended MassTox® TDM Series A
Validated according to IVDR (=> Declaration of Conformity)
5-Flucytosine
Anidulafungin
Caspofungin
Fluconazole
Isavuconazole
Itraconazole
Hydroxyitraconazole
Ketoconazole
Micafungin
Posaconazole
Voriconazole
Clinical relevance
This parameter set allows the quantitative determination of anidulafungin, caspofungin, fluconazole, 5-flucytosine, isavuconazole, itraconazole, hydroxyitraconazole, ketoconazole, micafungin, posaconazole and voriconazole in human serum or 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 antimycotic 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 | Isavuconazole: 0.219 mg/l – 44.0 mg/l For the values of all analytes please refer to the instruction manual. Different systems might show different performance data. |
| Specimen | Serum/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 | 0.5 to 50 µl (mass spectrometer dependent) |
| Flow Rate | 0.6 ml/min |
| Column Temperature | +20 to +25 °C |
| Gradient | binary |
| Ionisation | ESI positive and negative, polarity switch possible |
| MS/MS Mode | MRM |
| Parameters | 5-Flucytosine, Anidulafungin, Caspofungin, Fluconazole, Hydroxyitraconazole, Isavuconazole, Itraconazole, Ketoconazole, Micafungin, Posaconazole, Voriconazole |
92922/XT MassTox® TDM Parameter Set Antimycotic Drugs/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) |
| 92922/XT | MassTox® TDM Parameter Set Antimycotic Drugs/EXTENDED components |
| 92051/XT | 3PLUS1® Multilevel Plasma Calibrator Set Antimycotic Drugs/EXTENDED (lyoph.), 4 x 1 ml |
| 0253/XT | MassCheck® Antimycotic Drugs/EXTENDED Plasma Control, Level I (lyoph.), 5 x 1 ml |
| 0254/XT | MassCheck® Antimycotic Drugs/EXTENDED Plasma Control, Level II (lyoph.), 5 x 1 ml |
| 92644/XT | Internal Standard Mix Antimycotic Drugs/EXTENDED, 1 x 3.8 ml (for 200 tests) |
| Order No. | Required components (not included in the kit or the parameter set) |
| 92110 | MassTox® TDM MasterColumn® A, equilibrated, with test chromatogram, 1 pc. |
| 92039/XT | Tuning Mix Antimycotic Drugs/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. |
-
3PLUS1® Multilevel Plasma Calibrator Set Antimycotic Drugs/EXTENDEDOrder no.: 92051/XTMassTox® TDM Series A Antimycotic Drugs/EXTENDED in Serum/Plasma – LC-MS/MS -
MassCheck® Antimycotic Drugs/EXTENDED Plasma ControlsOrder no.: 0252/XT; 0253/XT; 0254/XTMassTox® TDM Series A Antimycotic Drugs/EXTENDED in Serum/Plasma – LC-MS/MS -
Internal Standard Mix Antimycotic Drugs/EXTENDEDOrder no.: 92644/XTComponent of the Parameter Set Antimycotic Drugs/EXTENDED, available separately
-
MassTox® TDM MasterColumn® AOrder no.: 92110Analytical column for MassTox® TDM Series A - LC-MS/MS
-
Tuning Mix Antimycotic Drugs/EXTENDEDOrder no.: 92039/XTTuning Mix for the Parameter Set Antimycotic Drugs/EXTENDED - LC-MS/MS -
Basic Kit A for 200 Tests - LC-MS/MSOrder no.: 92111/200Part 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.: 92111/1000Part 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 Antimycotic Drugs/EXTENDEDOrder no.: 92051/XTMassTox® TDM Series A Antimycotic Drugs/EXTENDED in Serum/Plasma – LC-MS/MS
-
MassCheck® Antimycotic Drugs/EXTENDED Plasma ControlsOrder no.: 0252/XT; 0253/XT; 0254/XTMassTox® TDM Series A Antimycotic Drugs/EXTENDED in Serum/Plasma – LC-MS/MS
Free Download Section
Declaration of Conformity
This assay is validated according to the new IVDR 2017/746.
You can view or download the Declaration of Conformity here.
Brochure
You want all the facts about our MassTox® TDM Series A at a glance?
You can download our brochure here.
Download Section for Customers
In this section customers can download various documents such as instruction manuals, product information leaflets, safety data sheets, traceability chains for calibrators, external quality assessments.
5-Flucytosine
Anidulafungin
Caspofungin
Fluconazole
Isavuconazole
Itraconazole
Hydroxyitraconazole
Ketoconazole
Micafungin
Posaconazole
Voriconazole
Clinical relevance
This parameter set allows the quantitative determination of anidulafungin, caspofungin, fluconazole, 5-flucytosine, isavuconazole, itraconazole, hydroxyitraconazole, ketoconazole, micafungin, posaconazole and voriconazole in human serum or 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 antimycotic 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 | Isavuconazole: 0.219 mg/l – 44.0 mg/l For the values of all analytes please refer to the instruction manual. Different systems might show different performance data. |
| Specimen | Serum/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 | 0.5 to 50 µl (mass spectrometer dependent) |
| Flow Rate | 0.6 ml/min |
| Column Temperature | +20 to +25 °C |
| Gradient | binary |
| Ionisation | ESI positive and negative, polarity switch possible |
| MS/MS Mode | MRM |
| Parameters | 5-Flucytosine, Anidulafungin, Caspofungin, Fluconazole, Hydroxyitraconazole, Isavuconazole, Itraconazole, Ketoconazole, Micafungin, Posaconazole, Voriconazole |
92922/XT MassTox® TDM Parameter Set Antimycotic Drugs/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) |
| 92922/XT | MassTox® TDM Parameter Set Antimycotic Drugs/EXTENDED components |
| 92051/XT | 3PLUS1® Multilevel Plasma Calibrator Set Antimycotic Drugs/EXTENDED (lyoph.), 4 x 1 ml |
| 0253/XT | MassCheck® Antimycotic Drugs/EXTENDED Plasma Control, Level I (lyoph.), 5 x 1 ml |
| 0254/XT | MassCheck® Antimycotic Drugs/EXTENDED Plasma Control, Level II (lyoph.), 5 x 1 ml |
| 92644/XT | Internal Standard Mix Antimycotic Drugs/EXTENDED, 1 x 3.8 ml (for 200 tests) |
| Order No. | Required components (not included in the kit or the parameter set) |
| 92110 | MassTox® TDM MasterColumn® A, equilibrated, with test chromatogram, 1 pc. |
| 92039/XT | Tuning Mix Antimycotic Drugs/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. |
-
3PLUS1® Multilevel Plasma Calibrator Set Antimycotic Drugs/EXTENDEDOrder no.: 92051/XTMassTox® TDM Series A Antimycotic Drugs/EXTENDED in Serum/Plasma – LC-MS/MS
-
MassCheck® Antimycotic Drugs/EXTENDED Plasma ControlsOrder no.: 0252/XT; 0253/XT; 0254/XTMassTox® TDM Series A Antimycotic Drugs/EXTENDED in Serum/Plasma – LC-MS/MS
-
Internal Standard Mix Antimycotic Drugs/EXTENDEDOrder no.: 92644/XTComponent of the Parameter Set Antimycotic Drugs/EXTENDED, available separately
-
MassTox® TDM MasterColumn® AOrder no.: 92110
Analytical column for MassTox® TDM Series A - LC-MS/MS
-
Tuning Mix Antimycotic Drugs/EXTENDEDOrder no.: 92039/XTTuning Mix for the Parameter Set Antimycotic Drugs/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 Antimycotic Drugs/EXTENDEDOrder no.: 92051/XTMassTox® TDM Series A Antimycotic Drugs/EXTENDED in Serum/Plasma – LC-MS/MS
-
MassCheck® Antimycotic Drugs/EXTENDED Plasma ControlsOrder no.: 0252/XT; 0253/XT; 0254/XTMassTox® TDM Series A Antimycotic Drugs/EXTENDED in Serum/Plasma – LC-MS/MS
Free Download Section
Declaration of Conformity
This assay is validated according to the new IVDR 2017/746.
You can view or download the Declaration of Conformity here.
Brochure
You want all the facts about our MassTox® TDM Series A at a glance?
You can download our brochure here.
Download Section for Customers
In this section customers can download various documents such as instruction manuals, product information leaflets, safety data sheets, traceability chains for calibrators, external quality assessments.