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

Order No.: 93900/400 & 93900/1200, for 400 / 1200 tests
Parameters:
Cyclosporin A, Everolimus, Sirolimus, Tacrolimus

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)

Grouped product items
Product Name Qty
MassTox® Immunosuppressants in Whole Blood – ONEMinute Test - LC-MS/MS
Order No.: 93900/400
MassTox® Immunosuppressants in Whole Blood – ONEMinute Test - LC-MS/MS
Order No.: 93900/1200

Cyclosporin A

Everolimus

Sirolimus

Tacrolimus

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

Kit for 400 tests (Order no. 93900/400)
Kit for 1200 tests, including Analytical Column, Trap Column and 6PLUS1® Multilevel Calibrator Set (Order no. 93900/1200)

 

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.

 

Content for 400 tests (93900/400)
Mobile Phase A, 2 x 900 ml (2x)
Mobile Phase B, 450 ml (1x)
Rinsing Solution, 1000 ml (1x)
Precipitation Reagent, 100 ml (1x)
Internal Standard Set, consisting of: Internal Standard Mix (lyoph.), 4x 2.5 ml, Reconstitution Buffer, 10 ml
Extraction Buffer, 40 ml (1x)
Reaction Vials, transparent, 100 pcs. (4x)

 

Content for 1200 tests (93900/1200)
Mobile Phase A, 900 ml (5x)
Mobile Phase B, 450 ml (3x)
Rinsing Solution, 1000 ml (2x)
Precipitation Reagent, 100 ml (3x)
Internal Standard Set, consisting of: Internal Standard Mix (lyoph.), 4x 2.5 ml (3x), Reconstitution Buffer, 10 ml (3x)
Extraction Buffer, 40 ml (3x)
Reaction Vials, transparent, 100 pcs. (12x)
6PLUS1® Multilevel Calibrator Set Immunosuppressants (XL), 7 x 2 ml (lyoph.)
Analytical Column, 1 pc.
Trap Column, 1 pc.

More Information
Method of Analysis LC-MS/MS
Number of Tests 400 / 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 a 1.5 ml reaction vial.
  • Add 25 µl reconstituted Internal Standard Mix.
  • Add 100 µl Extraction Buffer.
  • Add 250 µl Precipitation Reagent, mix 1 min (vortex) and incubate for 2 min at +20 to +25 °C.
  • Centrifuge for 5 min at 15000 x g.
  • Transfer supernatant into an autosampler vial.
  • 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
Order No.

MassChrom® Immunosuppressants in Whole Blood ONEMinute Test by LC-MS/MS

93900/400 Kit for 400 tests
93900/1200 Kit for 1200 tests, including Analytical Column, Trap Column and 6PLUS1® Multilevel Calibrator Set

 

Order No. Kit components (Quantities in kit for 400 tests)
93911 Mobile Phase A, 900 ml (2x)
93922 Mobile Phase B, 450 ml (1x)
93909 Rinsing Solution, 1000 ml (1x)
93003 Precipitation Reagent, 100 ml (1x)
93946 Internal Standard Set, consisting of:
Internal Standard Mix (lyoph.), 2.5 ml (4x)
Reconstitution Buffer, 10 ml (1x)
93005 Extraction Buffer, 40 ml (1x)
33006 Reaction Vials, 100 pcs. (4x)

 

Order No. Required components (not included in kit for 400 tests)
93100 Analytical Column, equilibrated, with test chromatogram, 1 pc.
93122 Trap Column, equilibrated, with test chromatogram, 1 pc.
28039/XL or 28039 6PLUS1® Multilevel Whole Blood Calibrator Set Immunosuppressants, 7 x 2 ml
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

 

Order No. General lab equipment (non-CE/IVD products)
33006 Reaction Vials, 100 pcs.
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

Kit for 400 tests (Order no. 93900/400)
Kit for 1200 tests, including Analytical Column, Trap Column and 6PLUS1® Multilevel Calibrator Set (Order no. 93900/1200)

 

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.

 

Content for 400 tests (93900/400)
Mobile Phase A, 2 x 900 ml (2x)
Mobile Phase B, 450 ml (1x)
Rinsing Solution, 1000 ml (1x)
Precipitation Reagent, 100 ml (1x)
Internal Standard Set, consisting of: Internal Standard Mix (lyoph.), 4x 2.5 ml, Reconstitution Buffer, 10 ml
Extraction Buffer, 40 ml (1x)
Reaction Vials, transparent, 100 pcs. (4x)

 

Content for 1200 tests (93900/1200)
Mobile Phase A, 900 ml (5x)
Mobile Phase B, 450 ml (3x)
Rinsing Solution, 1000 ml (2x)
Precipitation Reagent, 100 ml (3x)
Internal Standard Set, consisting of: Internal Standard Mix (lyoph.), 4x 2.5 ml (3x), Reconstitution Buffer, 10 ml (3x)
Extraction Buffer, 40 ml (3x)
Reaction Vials, transparent, 100 pcs. (12x)
6PLUS1® Multilevel Calibrator Set Immunosuppressants (XL), 7 x 2 ml (lyoph.)
Analytical Column, 1 pc.
Trap Column, 1 pc.

More Information
Method of Analysis LC-MS/MS
Number of Tests 400 / 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 a 1.5 ml reaction vial.
  • Add 25 µl reconstituted Internal Standard Mix.
  • Add 100 µl Extraction Buffer.
  • Add 250 µl Precipitation Reagent, mix 1 min (vortex) and incubate for 2 min at +20 to +25 °C.
  • Centrifuge for 5 min at 15000 x g.
  • Transfer supernatant into an autosampler vial.
  • 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
Order No.

MassChrom® Immunosuppressants in Whole Blood ONEMinute Test by LC-MS/MS

93900/400 Kit for 400 tests
93900/1200 Kit for 1200 tests, including Analytical Column, Trap Column and 6PLUS1® Multilevel Calibrator Set

 

Order No. Kit components (Quantities in kit for 400 tests)
93911 Mobile Phase A, 900 ml (2x)
93922 Mobile Phase B, 450 ml (1x)
93909 Rinsing Solution, 1000 ml (1x)
93003 Precipitation Reagent, 100 ml (1x)
93946 Internal Standard Set, consisting of:
Internal Standard Mix (lyoph.), 2.5 ml (4x)
Reconstitution Buffer, 10 ml (1x)
93005 Extraction Buffer, 40 ml (1x)
33006 Reaction Vials, 100 pcs. (4x)

 

Order No. Required components (not included in kit for 400 tests)
93100 Analytical Column, equilibrated, with test chromatogram, 1 pc.
93122 Trap Column, equilibrated, with test chromatogram, 1 pc.
28039/XL or 28039 6PLUS1® Multilevel Whole Blood Calibrator Set Immunosuppressants, 7 x 2 ml
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

 

Order No. General lab equipment (non-CE/IVD products)
33006 Reaction Vials, 100 pcs.
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.