MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in Serum/Plasma - LC-MS/MS
Isotopically labelled internal standard
Multilevel calibrators
Assay validated according to IVDR (=> Declaration of Conformity)
MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in Serum/Plasma by LC-MS/MS
Kit for 200 tests (Order no. 62062)
Kit for 1000 tests, including Analytical Column, Trap Column, 3PLUS1® Multilevel Calibrator Set and MassCheck® Controls (Order no. 62062/1000)
Clinical relevance
This assay allows the quantitative determination of 25-hydroxycholecalciferol (25-OH-vitamin D3) and 25-hydroxyergocalciferol (25-OH-vitamin D2), as well as 3-epi-25-OH-vitamin D3 in human plasma or serum samples.
It is intended to be used for screening and/or monitoring of 25-OH-vitamin D3/D2 levels where indicated:
- in patients with suspected vitamin D deficiency,
- in patients with suspected vitamin D insufficiency, or
- in patients with suspected vitamin D excess, and/or
- in patients under vitamin D supplementation therapy.
The test kit is further intended to be used as an aid to diagnosis of diseases for which determination of vitamin D levels is indicated.
This kit should be used when the levels of 3-epi-25-OH-vitamin D3 and 25-OH-vitamin D3 are to be determined separately.
Assay characteristics
Manual sample preparation is limited to simple and effective protein precipitation. The analytes are enriched with the aid of a trap column online and thus, interfering matrix components are separated. Chromatographic separation and further purification of all analytes is then performed by a special high‑resolution analytical column connected to the trap column by a valve. The method features the use of APCI (atmospheric pressure chemical ionisation) and the isotopically labelled internal standard adjusted to the epimeric forms. Matrix effects (“ion suppression”) are minimised and the precision and robustness of the method are optimised. The multilevel calibrator includes 25-hydroxyvitamin D3/D2 as well as the epimeric form 3-epi-25-hydroxyvitamin D3 and ensures high precision of results.
Detailed performance evaluation data for this assay can be found in Appendices II and III of the instruction manual.
Content for 200 tests (62062)
Mobile Phase A, 1000 ml (1x)
Mobile Phase B, 1000 ml (1x)
Precipitation Reagent, 5 ml (1x)
Internal Standard Mix, 40 ml (1x)
Rinsing Solution, 1000 ml (1x)
Reaction Vials, 100 pcs. (2x)
Content for 1000 tests (62062/1000)
Mobile Phase A, 1000 ml (5x)
Mobile Phase B, 1000 ml (5x)
Precipitation Reagent, 5 ml (5x)
Internal Standard Mix, 40 ml (5x)
Rinsing Solution, 1000 ml (2x)
Reaction Vials, 100 pcs. (10x)
3PLUS1® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 Multilevel Serum Calibrator Set (lyoph.), 1 ml (4x)
MassCheck® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 Serum Control, Level I (lyoph.), 1 ml (5x)
MassCheck® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 Serum Control, Level II (lyoph.), 1 ml (5x)
Analytical Column, 1 pc. (1x)
Trap Column, 1 pc. (2x)
| Method of Analysis | LC-MS/MS |
|---|---|
| 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 Appendices II and III of the instruction manual. |
| Lower and Upper Limit of Quantitation | 25-OH-Vitamin D3: 1.5 µg/l – 250 µg/l Different systems might show different performance data. |
| Specimen | Serum/Plasma |
| 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. Sample preparation with reaction vials:
For the sample preparation with 96 well filter plates, please refer to the instruction manual. |
| Run Time | 3.25 or 3.9 min (depending on gradient system) |
| Injection Volume | ≤ 50 µl (mass spectrometer dependent) |
| Column Temperature | Analytical Column: +40 °C / Trap Column: +20 to +25 °C |
| Ionisation | APCI positive |
| MS/MS Mode | MRM |
| Parameters | 25-OH-Vitamin D2, 25-OH-Vitamin D3, 3-epi-25-OH-Vitamin D3 |
| Order No. | MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in Serum/Plasma by LC-MS/MS |
| 62062 | Kit for 200 tests |
| 62062/1000 | Kit for 1000 tests, including Analytical Column, Trap Column, 3PLUS1® Multilevel Calibrator Set and MassCheck® Controls |
| Order No. | Kit components (Quantities in kit for 200 tests) |
| 62011 | Mobile Phase A, 1000 ml (1x) |
| 62022 | Mobile Phase B, 1000 ml (1x) |
| 62003 | Precipitation Reagent, 5 ml (1x) |
| 62045 | Internal Standard Mix, 40 ml (1x) |
| 62009 | Rinsing Solution, 1000 ml (1x) |
| 3006 | Reaction Vials, 100 pcs. (2x) |
| Order No. | Required components (not included in the kit for 200 tests) |
| 62130 | Analytical Column, equilibrated, with test chromatogram, 1 pc. |
| 62110/epi | Trap Column, equilibrated, with test chromatogram, 1 pc. |
| 62029 | 3PLUS1® Multilevel Serum Calibrator Set 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3, 4 x 1 ml (lyoph.) |
| 0311 | MassCheck® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 Serum Control Level I, 5 x 1 ml (lyoph.) |
| 0312 | MassCheck® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 Serum Control Level II, 5 x 1 ml (lyoph.) |
| 62017 | Tuning Mix 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3, Analytes and Internal Standards, 1 ml |
| Order No. | General lab equipment (non-CE/IVD products) |
| 3006 | 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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Mobile Phase AOrder no.: 62011MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in Serum/Plasma
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Mobile Phase BOrder no.: 62022MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in Serum/Plasma -
Internal Standard MixOrder no.: 62045MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in Serum/Plasma
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Analytical ColumnOrder no.: 62130MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in Serum/Plasma -
Trap ColumnOrder no.: 62110/EpiMassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in Serum/Plasma – LC-MS/MS -
3PLUS1® Multilevel Serum Calibrator Set (including epimeric form of Vitamin D3)Order no.: 62029MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MS -
MassCheck® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 Serum ControlsOrder no.: 0310/0311/0312MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MS
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Tuning Mix 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3Order no.: 62017MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in Serum/Plasma - LC-MS/MS
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3PLUS1® Multilevel Serum Calibrator Set (including epimeric form of Vitamin D3)Order no.: 62029MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MS
-
MassCheck® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 Serum ControlsOrder no.: 0310/0311/0312
MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MS
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Analytical ColumnOrder no.: 62130MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in Serum/Plasma
MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in Serum/Plasma by LC-MS/MS
Kit for 200 tests (Order no. 62062)
Kit for 1000 tests, including Analytical Column, Trap Column, 3PLUS1® Multilevel Calibrator Set and MassCheck® Controls (Order no. 62062/1000)
Clinical relevance
This assay allows the quantitative determination of 25-hydroxycholecalciferol (25-OH-vitamin D3) and 25-hydroxyergocalciferol (25-OH-vitamin D2), as well as 3-epi-25-OH-vitamin D3 in human plasma or serum samples.
It is intended to be used for screening and/or monitoring of 25-OH-vitamin D3/D2 levels where indicated:
- in patients with suspected vitamin D deficiency,
- in patients with suspected vitamin D insufficiency, or
- in patients with suspected vitamin D excess, and/or
- in patients under vitamin D supplementation therapy.
The test kit is further intended to be used as an aid to diagnosis of diseases for which determination of vitamin D levels is indicated.
This kit should be used when the levels of 3-epi-25-OH-vitamin D3 and 25-OH-vitamin D3 are to be determined separately.
Assay characteristics
Manual sample preparation is limited to simple and effective protein precipitation. The analytes are enriched with the aid of a trap column online and thus, interfering matrix components are separated. Chromatographic separation and further purification of all analytes is then performed by a special high‑resolution analytical column connected to the trap column by a valve. The method features the use of APCI (atmospheric pressure chemical ionisation) and the isotopically labelled internal standard adjusted to the epimeric forms. Matrix effects (“ion suppression”) are minimised and the precision and robustness of the method are optimised. The multilevel calibrator includes 25-hydroxyvitamin D3/D2 as well as the epimeric form 3-epi-25-hydroxyvitamin D3 and ensures high precision of results.
Detailed performance evaluation data for this assay can be found in Appendices II and III of the instruction manual.
Content for 200 tests (62062)
Mobile Phase A, 1000 ml (1x)
Mobile Phase B, 1000 ml (1x)
Precipitation Reagent, 5 ml (1x)
Internal Standard Mix, 40 ml (1x)
Rinsing Solution, 1000 ml (1x)
Reaction Vials, 100 pcs. (2x)
Content for 1000 tests (62062/1000)
Mobile Phase A, 1000 ml (5x)
Mobile Phase B, 1000 ml (5x)
Precipitation Reagent, 5 ml (5x)
Internal Standard Mix, 40 ml (5x)
Rinsing Solution, 1000 ml (2x)
Reaction Vials, 100 pcs. (10x)
3PLUS1® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 Multilevel Serum Calibrator Set (lyoph.), 1 ml (4x)
MassCheck® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 Serum Control, Level I (lyoph.), 1 ml (5x)
MassCheck® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 Serum Control, Level II (lyoph.), 1 ml (5x)
Analytical Column, 1 pc. (1x)
Trap Column, 1 pc. (2x)
| Method of Analysis | LC-MS/MS |
|---|---|
| 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 Appendices II and III of the instruction manual. |
| Lower and Upper Limit of Quantitation | 25-OH-Vitamin D3: 1.5 µg/l – 250 µg/l Different systems might show different performance data. |
| Specimen | Serum/Plasma |
| 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. Sample preparation with reaction vials:
For the sample preparation with 96 well filter plates, please refer to the instruction manual. |
| Run Time | 3.25 or 3.9 min (depending on gradient system) |
| Injection Volume | ≤ 50 µl (mass spectrometer dependent) |
| Column Temperature | Analytical Column: +40 °C / Trap Column: +20 to +25 °C |
| Ionisation | APCI positive |
| MS/MS Mode | MRM |
| Parameters | 25-OH-Vitamin D2, 25-OH-Vitamin D3, 3-epi-25-OH-Vitamin D3 |
| Order No. | MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in Serum/Plasma by LC-MS/MS |
| 62062 | Kit for 200 tests |
| 62062/1000 | Kit for 1000 tests, including Analytical Column, Trap Column, 3PLUS1® Multilevel Calibrator Set and MassCheck® Controls |
| Order No. | Kit components (Quantities in kit for 200 tests) |
| 62011 | Mobile Phase A, 1000 ml (1x) |
| 62022 | Mobile Phase B, 1000 ml (1x) |
| 62003 | Precipitation Reagent, 5 ml (1x) |
| 62045 | Internal Standard Mix, 40 ml (1x) |
| 62009 | Rinsing Solution, 1000 ml (1x) |
| 3006 | Reaction Vials, 100 pcs. (2x) |
| Order No. | Required components (not included in the kit for 200 tests) |
| 62130 | Analytical Column, equilibrated, with test chromatogram, 1 pc. |
| 62110/epi | Trap Column, equilibrated, with test chromatogram, 1 pc. |
| 62029 | 3PLUS1® Multilevel Serum Calibrator Set 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3, 4 x 1 ml (lyoph.) |
| 0311 | MassCheck® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 Serum Control Level I, 5 x 1 ml (lyoph.) |
| 0312 | MassCheck® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 Serum Control Level II, 5 x 1 ml (lyoph.) |
| 62017 | Tuning Mix 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3, Analytes and Internal Standards, 1 ml |
| Order No. | General lab equipment (non-CE/IVD products) |
| 3006 | 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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Mobile Phase AOrder no.: 62011
MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in Serum/Plasma
-
Mobile Phase BOrder no.: 62022MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in Serum/Plasma
-
Internal Standard MixOrder no.: 62045MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in Serum/Plasma
-
Analytical ColumnOrder no.: 62130MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in Serum/Plasma
-
Trap ColumnOrder no.: 62110/EpiMassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in Serum/Plasma – LC-MS/MS
-
3PLUS1® Multilevel Serum Calibrator Set (including epimeric form of Vitamin D3)Order no.: 62029MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MS
-
MassCheck® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 Serum ControlsOrder no.: 0310/0311/0312
MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MS
-
Tuning Mix 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3Order no.: 62017MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in Serum/Plasma - LC-MS/MS
-
3PLUS1® Multilevel Serum Calibrator Set (including epimeric form of Vitamin D3)Order no.: 62029MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MS
-
MassCheck® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 Serum ControlsOrder no.: 0310/0311/0312
MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MS
-
Analytical ColumnOrder no.: 62130MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in Serum/Plasma