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

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

Cyclosporin A

Everolimus

Sirolimus

Tacrolimus

MassChrom® Immunosuppressants in Whole Blood – ONEMinute Test
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 monitoring test for patients treated with immunosuppressants and as an aid to ensure drug levels within the therapeutic range.

 

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.

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 appendices 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 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.

  • Load liquid handling device with samples, reagents, 96 deep well extraction plate and collection plate.
  • Start the automation routine*.
  • After completion remove collection plate from the liquid handling device, seal with a heat seal and transfer to autosampler.
  • Inject 5–50 μl eluate into the HPLC system.

* Ready to use automation routine provided with the installation by Chromsystems.

Injection Volume 5–50 µl
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

 

Order No. General lab equipment (non-CE/IVD products)
93060 Pierceable Heat Seals for 96 Well Plates, 6 pcs.
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:
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 – ONEMinute Test
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 monitoring test for patients treated with immunosuppressants and as an aid to ensure drug levels within the therapeutic range.

 

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.

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 appendices 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 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.

  • Load liquid handling device with samples, reagents, 96 deep well extraction plate and collection plate.
  • Start the automation routine*.
  • After completion remove collection plate from the liquid handling device, seal with a heat seal and transfer to autosampler.
  • Inject 5–50 μl eluate into the HPLC system.

* Ready to use automation routine provided with the installation by Chromsystems.

Injection Volume 5–50 µl
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

 

Order No. General lab equipment (non-CE/IVD products)
93060 Pierceable Heat Seals for 96 Well Plates, 6 pcs.
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:
General lab equipment (non-CE-IVD products), available from Chromsystems:
As a customer please login or register to gain full access.