Parameter Set Antimycotic Drugs/EXTENDED - LC-MS/MS

Order No.: 92922/XT
Parameters:
5-Flucytosine, Anidulafungin, Caspofungin, Fluconazole, Hydroxyitraconazole, Isavuconazole, Itraconazole, Ketoconazole, Micafungin, Posaconazole, Voriconazole

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

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 Appendices II and III of the instruction manual.
Lower and Upper Limit of Quantitation

Isavuconazole: 0.219 mg/l – 44.0 mg/l
Itraconazole: 0.009 mg/l – 4.00 mg/l
Hydroxyitraconazole: 0.043 mg/l – 5.26 mg/l
Posaconazole: 0.068 mg/l – 10.0 mg/l
Voriconazole: 0.065 mg/l – 16.0 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.

  • 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 supernatant with Dilution Buffer (depending on instrument sensitivity) and inject into LC-MS/MS system.
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. 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.
The following components are included in the kit:
The following products are not included in the kit but are required for the application of the method:

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.

As a customer please login or register to gain full access.

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

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 Appendices II and III of the instruction manual.
Lower and Upper Limit of Quantitation

Isavuconazole: 0.219 mg/l – 44.0 mg/l
Itraconazole: 0.009 mg/l – 4.00 mg/l
Hydroxyitraconazole: 0.043 mg/l – 5.26 mg/l
Posaconazole: 0.068 mg/l – 10.0 mg/l
Voriconazole: 0.065 mg/l – 16.0 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.

  • 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 supernatant with Dilution Buffer (depending on instrument sensitivity) and inject into LC-MS/MS system.
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. 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.
The following components are included in the kit:
The following products are not included in the kit but are required for the application of the method:

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.

As a customer please login or register to gain full access.