Parameter Set Mycophenolic Acid - LC-MS/MS

Order No.: 92916
Parameters:
Mycophenolic Acid, Mycophenolic Acid Glucuronide

For the analysis of MPA and MPAG
3PLUS1® and 6PLUS1® Multilevel Calibrator Sets available
Part of the continuously extended MassTox® TDM Series A

CE-IVD validated product ready for IVDR within timeframes and transition periods specified by the IVDR 2017/746

Mycophenolic Acid

Mycophenolic Acid Glucuronide

Clinical relevance

Mycophenolic acid (MPA) is used as an immunosuppressant agent to prevent organ transplant rejection. MPA selectively inhibits the synthesis of purines and specifically reduces the growth of B- and T-lymphocytes. Furthermore, MPA is also used to treat autoimmune diseases such as psoriasis, systemic lupus erythematosus or scleroderma.

Therapeutic monitoring of MPA in the blood is required to adjust individual concentrations within the therapeutic window and to attain a favourable ratio between therapeutic effects and side effects. Currently available drugs contain mycophenolate mofetil or mycophenolate sodium, which are both completely metabolised into the active metabolite MPA. For excretion, MPA is bound to glucuronic acid.

This parameter set allows the quantitative determination of mycophenolic acid and its metabolite mycophenolic acid glucuronide in human serum or plasma samples by LC-MS/MS.
It is intended as a therapeutic drug monitoring test, medically indicated for patients treated with mycophenolate mofetil or mycophenolate sodium.

 

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

There is also a CE-IVD compliant workflow method available using the MassSTAR to automate the sample preparation. => Parameter Set 92716

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

MPA: 0.2 – 75 mg/l
MPAG: 2.5 – 500 mg/l

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.

Sample preparation with reaction vials:
• Pipette 50 µL sample/calibrator/control into a 1.5 mL Reaction Vial.
• Add 25 µL Extraction Buffer, vortex briefly and incubate for 2 min.
• Add 250 µL of the prepared Internal Standard Solution.
• Vortex for at least 30 s.
• Centrifuge for 5 min.
• Dilute the supernatant according to the dilution scheme.
• Inject ≤ 25 µL into the LC-MS/MS system.

For the sample preparation with 96 well filter plates, please refer to the instruction manual.

Run Time 1.8 min
Injection Volume ≤ 25 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 Mycophenolic Acid, Mycophenolic Acid Glucuronide

92916 MassTox® TDM Parameter Set Mycophenolic Acid

Order No. MassTox® TDM Basic Kit A
92111/200 Basic Kit A for 200 tests
92111/1000 Basic Kit A for 1000 tests
92111/1000/F Basic Kit A for 1000 tests, for sample preparation with 96 well filter plates

 

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)

 

92916 MassTox® TDM Parameter Set Mycophenolic Acid/Glucuronide components
46029 3PLUS1® Multilevel Plasma Calibrator Set Mycophenolic Acid/Glucuronide, 4 x 1 ml (lyoph.)
0235 MassCheck® Mycophenolic Acid/Glucuronide Plasma Control, Level I, 5 x 1 ml (lyoph.)
0236 MassCheck® Mycophenolic Acid/Glucuronide Plasma Control, Level II, 5 x 1 ml (lyoph.)
92246 Internal Standard Set Mycophenolic Acid/Glucuronide, 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.
92019 Tuning Mix Mycophenolic Acid/Glucuronide (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.
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:
As a customer please login or register to gain full access.

Mycophenolic Acid

Mycophenolic Acid Glucuronide

Clinical relevance

Mycophenolic acid (MPA) is used as an immunosuppressant agent to prevent organ transplant rejection. MPA selectively inhibits the synthesis of purines and specifically reduces the growth of B- and T-lymphocytes. Furthermore, MPA is also used to treat autoimmune diseases such as psoriasis, systemic lupus erythematosus or scleroderma.

Therapeutic monitoring of MPA in the blood is required to adjust individual concentrations within the therapeutic window and to attain a favourable ratio between therapeutic effects and side effects. Currently available drugs contain mycophenolate mofetil or mycophenolate sodium, which are both completely metabolised into the active metabolite MPA. For excretion, MPA is bound to glucuronic acid.

This parameter set allows the quantitative determination of mycophenolic acid and its metabolite mycophenolic acid glucuronide in human serum or plasma samples by LC-MS/MS.
It is intended as a therapeutic drug monitoring test, medically indicated for patients treated with mycophenolate mofetil or mycophenolate sodium.

 

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

There is also a CE-IVD compliant workflow method available using the MassSTAR to automate the sample preparation. => Parameter Set 92716

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

MPA: 0.2 – 75 mg/l
MPAG: 2.5 – 500 mg/l

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.

Sample preparation with reaction vials:
• Pipette 50 µL sample/calibrator/control into a 1.5 mL Reaction Vial.
• Add 25 µL Extraction Buffer, vortex briefly and incubate for 2 min.
• Add 250 µL of the prepared Internal Standard Solution.
• Vortex for at least 30 s.
• Centrifuge for 5 min.
• Dilute the supernatant according to the dilution scheme.
• Inject ≤ 25 µL into the LC-MS/MS system.

For the sample preparation with 96 well filter plates, please refer to the instruction manual.

Run Time 1.8 min
Injection Volume ≤ 25 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 Mycophenolic Acid, Mycophenolic Acid Glucuronide

92916 MassTox® TDM Parameter Set Mycophenolic Acid

Order No. MassTox® TDM Basic Kit A
92111/200 Basic Kit A for 200 tests
92111/1000 Basic Kit A for 1000 tests
92111/1000/F Basic Kit A for 1000 tests, for sample preparation with 96 well filter plates

 

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)

 

92916 MassTox® TDM Parameter Set Mycophenolic Acid/Glucuronide components
46029 3PLUS1® Multilevel Plasma Calibrator Set Mycophenolic Acid/Glucuronide, 4 x 1 ml (lyoph.)
0235 MassCheck® Mycophenolic Acid/Glucuronide Plasma Control, Level I, 5 x 1 ml (lyoph.)
0236 MassCheck® Mycophenolic Acid/Glucuronide Plasma Control, Level II, 5 x 1 ml (lyoph.)
92246 Internal Standard Set Mycophenolic Acid/Glucuronide, 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.
92019 Tuning Mix Mycophenolic Acid/Glucuronide (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.
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:
As a customer please login or register to gain full access.