MassTox® Immunosuppressants in Whole Blood – ONEMinute Test - LC-MS/MS

Order No.: 93900/1200/DWP, for 1200 tests
Parameters:
Cyclosporin A, Everolimus, Sirolimus, Tacrolimus

For sample preparation with 96 Deep Well Extraction Plates
Short run time
Isotopically labelled internal standard for each analyte
6PLUS1® Multilevel Calibrator Set and MassCheck® controls
Additional trap column for removing interfering substances

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

Cyclosporin A

Everolimus

Sirolimus

Tacrolimus

MassChrom® Immunosuppressants in Whole Blood – ONEMinute Test by LC-MS/MS
For sample preparation with 96 Deep Well Extraction Plates

Kit for 1200 tests

 

Clinical Relevance

This assay allows the quantitative determination of cyclosporin A, everolimus, sirolimus (rapamycin) and tacrolimus (FK-506) in human EDTA whole blood samples via liquid chromatography-mass spectrometry (LC-MS/MS).

It is intended as a therapeutic drug monitoring test for patients treated with one or several immunosuppressants named above.

 

Product advantages

• Short run time
• Isotopically labelled internal standard for each analyte
• 6PLUS1® Multilevel Calibrator Set and MassCheck® controls
• Additional trap column for removing interfering substances

 

Assay characteristics

The manual preparation of the sample is limited to a simple and effective protein precipitation process. The analytes are enriched, and interfering substances removed via a trap column. Chromatographic separation is then performed by an analytical column connected to a 2-position 6-port, or 2-position 10-port valve. The use of isotopically-labelled internal standards ensures the precision and robustness of the method and compensates for matrix effects (such as ion suppression).

Detailed performance evaluation data for this assay can be found in the appendix of the instruction manual.

More Information
Method of Analysis LC-MS/MS
Number of Tests 1200
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

Cyclosporin A: 6.0 – 2000 µg/l
Everolimus: 0.5 – 100 µg/l
Sirolimus: 0.5 – 100 µg/l
Tacrolimus: 0.5 – 100 µg/l

Different systems might show different performance data.

Specimen EDTA Whole Blood
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.

  • Pipette 50 µl sample/calibrator/MassCheck® control into 96 Deep Well Extraction Plate.
  • Add 25 µl reconstituted Internal Standard Mix.
  • Add 100 µl Extraction Buffer.
  • Add 250 µl Precipitation Reagent and shake for 3 min.
  • Separate precipitate by centrifugation (3 min).
  • Transfer supernatant into a 96 Well Collection Plate, seal 96 Well Collection Plate and transfer to autosampler.
  • Inject 5 – 50 µl into the LC-MS/MS system.
Run Time 1 – 2 min
Injection Volume 5 – 50 µl
Ionisation ESI positive
MS/MS Mode MRM
Parameters Cyclosporin A, Everolimus, Sirolimus, Tacrolimus

93900/1200/DWP MassChrom® Immunosuppressants in Whole Blood – ONEMinute Test
For sample preparation with 96 Deep Well Extraction Plates
Kit for 1200 tests

Order No. Kit components (Quantities in kit)
93911 Mobile Phase A, 900 ml (5x)
93922 Mobile Phase B, 450 ml (3x)
93909 Rinsing Solution, 1000 ml (2x)
93003 Precipitation Reagent, 100 ml (3x)
93946 Internal Standard Set, consisting of:
Internal Standard Mix (lyoph.), 4x 2.5 ml (3x)
Reconstitution Buffer, 10 ml (3x)
93005 Extraction Buffer, 40 ml (3x)
93056 96 Deep Well Extraction Plates, 5 pcs. (3x)
93058 96 Well Collection Plates , 5 pcs. (3x)
93059 Pierceable Adhesive Seals for 96 Well Plates, 5 pcs. (3x)
28039/XL 6PLUS1® Multilevel Whole Blood Calibrator Set Immunosuppressants, 7 x 2 ml
93100 Analytical Column, equilibrated, with test chromatogram, 1 pc.
93122 Trap Column, equilibrated, with test chromatogram, 1 pc.

 

Order No. Required components (not included in kit)
0082 MassCheck®  Immunosuppressants Whole Blood Control Level I, 5 x 2 ml
0083 MassCheck®  Immunosuppressants Whole Blood Control Level II, 5 x 2 ml
0084 MassCheck®  Immunosuppressants Whole Blood Control Level III, 5 x 2 ml
0085 MassCheck®  Immunosuppressants Whole Blood Control Level IV, 5 x 2 ml
0089 MassCheck®  Immunosuppressants Whole Blood Blank Control, 5 x 2 ml
93915 Tuning Mix Immunosuppressants, Analytes and Internal Standards, 1 ml
93060 Pierceable Heat Seals for 96 Well Plates, 6 pcs.
(can be used as an alternative to 93059 - Pierceable Adhesive Seals for 96 Well Plates)

 

Order No. Lab Equipment
42740 Chromsystems Heat Sealer, 1 pc.
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.
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.

Cyclosporin A

Everolimus

Sirolimus

Tacrolimus

MassChrom® Immunosuppressants in Whole Blood – ONEMinute Test by LC-MS/MS
For sample preparation with 96 Deep Well Extraction Plates

Kit for 1200 tests

 

Clinical Relevance

This assay allows the quantitative determination of cyclosporin A, everolimus, sirolimus (rapamycin) and tacrolimus (FK-506) in human EDTA whole blood samples via liquid chromatography-mass spectrometry (LC-MS/MS).

It is intended as a therapeutic drug monitoring test for patients treated with one or several immunosuppressants named above.

 

Product advantages

• Short run time
• Isotopically labelled internal standard for each analyte
• 6PLUS1® Multilevel Calibrator Set and MassCheck® controls
• Additional trap column for removing interfering substances

 

Assay characteristics

The manual preparation of the sample is limited to a simple and effective protein precipitation process. The analytes are enriched, and interfering substances removed via a trap column. Chromatographic separation is then performed by an analytical column connected to a 2-position 6-port, or 2-position 10-port valve. The use of isotopically-labelled internal standards ensures the precision and robustness of the method and compensates for matrix effects (such as ion suppression).

Detailed performance evaluation data for this assay can be found in the appendix of the instruction manual.

More Information
Method of Analysis LC-MS/MS
Number of Tests 1200
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

Cyclosporin A: 6.0 – 2000 µg/l
Everolimus: 0.5 – 100 µg/l
Sirolimus: 0.5 – 100 µg/l
Tacrolimus: 0.5 – 100 µg/l

Different systems might show different performance data.

Specimen EDTA Whole Blood
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.

  • Pipette 50 µl sample/calibrator/MassCheck® control into 96 Deep Well Extraction Plate.
  • Add 25 µl reconstituted Internal Standard Mix.
  • Add 100 µl Extraction Buffer.
  • Add 250 µl Precipitation Reagent and shake for 3 min.
  • Separate precipitate by centrifugation (3 min).
  • Transfer supernatant into a 96 Well Collection Plate, seal 96 Well Collection Plate and transfer to autosampler.
  • Inject 5 – 50 µl into the LC-MS/MS system.
Run Time 1 – 2 min
Injection Volume 5 – 50 µl
Ionisation ESI positive
MS/MS Mode MRM
Parameters Cyclosporin A, Everolimus, Sirolimus, Tacrolimus

93900/1200/DWP MassChrom® Immunosuppressants in Whole Blood – ONEMinute Test
For sample preparation with 96 Deep Well Extraction Plates
Kit for 1200 tests

Order No. Kit components (Quantities in kit)
93911 Mobile Phase A, 900 ml (5x)
93922 Mobile Phase B, 450 ml (3x)
93909 Rinsing Solution, 1000 ml (2x)
93003 Precipitation Reagent, 100 ml (3x)
93946 Internal Standard Set, consisting of:
Internal Standard Mix (lyoph.), 4x 2.5 ml (3x)
Reconstitution Buffer, 10 ml (3x)
93005 Extraction Buffer, 40 ml (3x)
93056 96 Deep Well Extraction Plates, 5 pcs. (3x)
93058 96 Well Collection Plates , 5 pcs. (3x)
93059 Pierceable Adhesive Seals for 96 Well Plates, 5 pcs. (3x)
28039/XL 6PLUS1® Multilevel Whole Blood Calibrator Set Immunosuppressants, 7 x 2 ml
93100 Analytical Column, equilibrated, with test chromatogram, 1 pc.
93122 Trap Column, equilibrated, with test chromatogram, 1 pc.

 

Order No. Required components (not included in kit)
0082 MassCheck®  Immunosuppressants Whole Blood Control Level I, 5 x 2 ml
0083 MassCheck®  Immunosuppressants Whole Blood Control Level II, 5 x 2 ml
0084 MassCheck®  Immunosuppressants Whole Blood Control Level III, 5 x 2 ml
0085 MassCheck®  Immunosuppressants Whole Blood Control Level IV, 5 x 2 ml
0089 MassCheck®  Immunosuppressants Whole Blood Blank Control, 5 x 2 ml
93915 Tuning Mix Immunosuppressants, Analytes and Internal Standards, 1 ml
93060 Pierceable Heat Seals for 96 Well Plates, 6 pcs.
(can be used as an alternative to 93059 - Pierceable Adhesive Seals for 96 Well Plates)

 

Order No. Lab Equipment
42740 Chromsystems Heat Sealer, 1 pc.
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.
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.