MassTox® Immunosuppressants in Whole Blood - LC-MS/MS

Order No.: 93000 & 93000/1200, for 400 / 1200 tests
Parameters:
Cyclosporin A, Everolimus, Sirolimus, Tacrolimus

Reduced matrix effects through online sample preparation with trap column technology and isotope-labelled internal standards
High sensitivity and selectivity

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

Grouped product items
Product Name Qty
MassTox® Immunosuppressants in Whole Blood - LC-MS/MS
Order No.: 93000
MassTox® Immunosuppressants in Whole Blood - LC-MS/MS
Order No.: 93000/1200

Cyclosporin A

Everolimus

Sirolimus

Tacrolimus

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

Kit for 400 tests (Order no. 93000)
Kit for 1200 tests, including Analytical Column, Trap Column and 6PLUS1® Multilevel Calibrator Set (Order no. 93000/1200)

 

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 monitoring test for patients treated with immunosuppressants and as an aid to ensure drug levels within the therapeutic range.

 

Product advantages

• Reduced matrix effects through online sample preparation with trap column technology and isotope-labelled internal standards
• High sensitivity and selectivity

 

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 Appendices II and III of the instruction manual.

For accelerated analysis and higher sample throughput, we also offer the ONEMINUTE Method for LC-MS/MS (order no. 93900).

 

Content for 400 tests (93000)
Mobile Phase A, 1000 ml (1x)
Mobile Phase B, 1000 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, light protected, 100 pcs. (4x)

 

Content for 1200 tests (93000/1200)
Mobile Phase A, 1000 ml (3x)
Mobile Phase B, 1000 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, light protected, 100 pcs. (12x)
6PLUS1® Multilevel Calibrator Set Immunosuppressants, 7 x 2 ml (lyoph.)
Analytical Column, 1 pc.
Trap Column, 2 pcs.

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 appendices of the instruction manual.
Lower and Upper Limit of Quantitation

Cyclosporin A: 5.0 – 2000 µg/l
Everolimus: 0.5 – 80 µg/l
Sirolimus: 0.5 – 80 µg/l
Tacrolimus: 0.5 – 80 µg/l

Different systems might show different performance data.

Specimen 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.

  • Place 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 mix 10 s (vortex) and incubate for 2 min at ambient temperature.
  • Add 250 µl Precipitation Reagent,  mix 1 min (vortex) and incubate for 2 min at ambient temperature.
  • Centrifuge 5 min at 15000 x g.
  • Transfer supernatant into an autosampler vial and inject 5–25 µl into the LC-MS/MS systems.
Run Time 4.5 min
Injection Volume 5–25 µl
Ionisation ESI positive
MS/MS Mode MRM
Parameters Cyclosporin A, Everolimus, Sirolimus, Tacrolimus
Order No.

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

93000 Kit for 400 tests
93000/1200 Kit for 1000 tests, including Analytical Column, Trap Column and 6PLUS1® Multilevel Calibrator Set

 

Order No. Kit components (Quantities in kit for 400 tests)
93001 Mobile Phase A, 1000 ml (1x)
93002 Mobile Phase B, 1000 ml (1x)
93009 Rinsing Solution, 1000 ml (1x)
93003 Precipitation Reagent, 100 ml (1x)
93046 Internal Standard Set, consisting of:
Internal Standard Mix (lyoph.), 2.5 ml (4x)
Reconstitution Buffer, 10 ml (1x)
93005 Extraction Buffer, 40 ml (1x)
33005 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.
93110 Trap Column, equilibrated, with test chromatogram, 1 pc.
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
93015 Tuning Mix Immunosuppressants, Analytes and Internal Standards, 1 ml

 

Order No. General lab equipment (non-CE/IVD products)
33005 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:
General lab equipment (non-CE-IVD products), available from Chromsystems:
As a customer please login or register to gain full access.

Cyclosporin A

Everolimus

Sirolimus

Tacrolimus

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

Kit for 400 tests (Order no. 93000)
Kit for 1200 tests, including Analytical Column, Trap Column and 6PLUS1® Multilevel Calibrator Set (Order no. 93000/1200)

 

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 monitoring test for patients treated with immunosuppressants and as an aid to ensure drug levels within the therapeutic range.

 

Product advantages

• Reduced matrix effects through online sample preparation with trap column technology and isotope-labelled internal standards
• High sensitivity and selectivity

 

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 Appendices II and III of the instruction manual.

For accelerated analysis and higher sample throughput, we also offer the ONEMINUTE Method for LC-MS/MS (order no. 93900).

 

Content for 400 tests (93000)
Mobile Phase A, 1000 ml (1x)
Mobile Phase B, 1000 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, light protected, 100 pcs. (4x)

 

Content for 1200 tests (93000/1200)
Mobile Phase A, 1000 ml (3x)
Mobile Phase B, 1000 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, light protected, 100 pcs. (12x)
6PLUS1® Multilevel Calibrator Set Immunosuppressants, 7 x 2 ml (lyoph.)
Analytical Column, 1 pc.
Trap Column, 2 pcs.

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 appendices of the instruction manual.
Lower and Upper Limit of Quantitation

Cyclosporin A: 5.0 – 2000 µg/l
Everolimus: 0.5 – 80 µg/l
Sirolimus: 0.5 – 80 µg/l
Tacrolimus: 0.5 – 80 µg/l

Different systems might show different performance data.

Specimen 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.

  • Place 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 mix 10 s (vortex) and incubate for 2 min at ambient temperature.
  • Add 250 µl Precipitation Reagent,  mix 1 min (vortex) and incubate for 2 min at ambient temperature.
  • Centrifuge 5 min at 15000 x g.
  • Transfer supernatant into an autosampler vial and inject 5–25 µl into the LC-MS/MS systems.
Run Time 4.5 min
Injection Volume 5–25 µl
Ionisation ESI positive
MS/MS Mode MRM
Parameters Cyclosporin A, Everolimus, Sirolimus, Tacrolimus
Order No.

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

93000 Kit for 400 tests
93000/1200 Kit for 1000 tests, including Analytical Column, Trap Column and 6PLUS1® Multilevel Calibrator Set

 

Order No. Kit components (Quantities in kit for 400 tests)
93001 Mobile Phase A, 1000 ml (1x)
93002 Mobile Phase B, 1000 ml (1x)
93009 Rinsing Solution, 1000 ml (1x)
93003 Precipitation Reagent, 100 ml (1x)
93046 Internal Standard Set, consisting of:
Internal Standard Mix (lyoph.), 2.5 ml (4x)
Reconstitution Buffer, 10 ml (1x)
93005 Extraction Buffer, 40 ml (1x)
33005 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.
93110 Trap Column, equilibrated, with test chromatogram, 1 pc.
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
93015 Tuning Mix Immunosuppressants, Analytes and Internal Standards, 1 ml

 

Order No. General lab equipment (non-CE/IVD products)
33005 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:
General lab equipment (non-CE-IVD products), available from Chromsystems:
As a customer please login or register to gain full access.