MassTox® Immunosuppressants in Whole Blood – ONEMinute Test - LC-MS/MS
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
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.
| 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 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.
|
| 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. | Lab equipment |
| 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. |
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Analytical Column Immunosuppressants in Whole Blood - LC-MS/MSOrder no.: 93100MassTox® Immunosuppressants in Whole Blood - LC-MS/MS
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6PLUS1® Multilevel Whole Blood Calibrator Set ImmunosuppressantsOrder no.: 28039/XLMassTox® Immunosuppressants in Whole Blood – LC-MS/MS -
Tuning Mix Immunosuppressants ONEMinute TestOrder no.: 93915MassTox® Immunosuppressants ONEMinute Test - LC-MS/MS
-
6PLUS1® Multilevel Whole Blood Calibrator Set ImmunosuppressantsOrder no.: 28039/XLMassTox® Immunosuppressants in Whole Blood – LC-MS/MS
-
6PLUS1® Multilevel Whole Blood Calibrator Set ImmunosuppressantsOrder no.: 28039MassTox® Immunosuppressants in Whole Blood – LC-MS/MS
-
Analytical Column Immunosuppressants in Whole Blood - LC-MS/MSOrder no.: 93100
MassTox® Immunosuppressants in Whole Blood - LC-MS/MS
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.
| 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 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.
|
| 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. | Lab equipment |
| 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. |
-
Analytical Column Immunosuppressants in Whole Blood - LC-MS/MSOrder no.: 93100
MassTox® Immunosuppressants in Whole Blood - LC-MS/MS
-
6PLUS1® Multilevel Whole Blood Calibrator Set ImmunosuppressantsOrder no.: 28039/XLMassTox® Immunosuppressants in Whole Blood – LC-MS/MS
-
Tuning Mix Immunosuppressants ONEMinute TestOrder no.: 93915
MassTox® Immunosuppressants ONEMinute Test - LC-MS/MS
-
6PLUS1® Multilevel Whole Blood Calibrator Set ImmunosuppressantsOrder no.: 28039/XLMassTox® Immunosuppressants in Whole Blood – LC-MS/MS
-
6PLUS1® Multilevel Whole Blood Calibrator Set ImmunosuppressantsOrder no.: 28039MassTox® Immunosuppressants in Whole Blood – LC-MS/MS
-
Analytical Column Immunosuppressants in Whole Blood - LC-MS/MSOrder no.: 93100
MassTox® Immunosuppressants in Whole Blood - LC-MS/MS