MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MS
Isotopically labelled internal standard
Multilevel calibrators
Assay validated according to IVDR (=> Declaration of Conformity)
25-OH-Vitamin D2
25-OH-Vitamin D3
MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma by LC-MS/MS
Kit for 200 tests (Order no. 62000)
Kit for 1000 tests, including Analytical Column, Trap Column, 3PLUS1® Multilevel Calibrator Set and MassCheck® Controls (Order no. 62000/1000)
Clinical relevance
This assay allows the quantitative determination of 25-hydroxycholecalciferol (25-OH-vitamin D3) and 25-hydroxyergocalciferol (25-OH-vitamin D2) 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 assay is further intended to be used as an aid to diagnosis of diseases for which determination of vitamin D levels is indicated.
Assay characteristics
Manual sample preparation is limited to simple and effective protein precipitation. A trap column concentrates the analytes and separates interfering substances. A two-position-six-port-valve connects the trap column to an HPLC column where the chromatographic separation takes place. The use of atmospheric pressure chemical ionisation (APCI) and a deuterated internal standard assures precision and robustness and minimises ion suppression effects.
This kit does not separate 3-epi-25-OH-vitamin D3 and 3-epi-25-OH-vitamin D2 from 25-OH-vitamin D3 and 25-OH-vitamin D2, respectively, and should therefore only be used to analyse samples that contain none or just negligible amounts of these metabolites.
We recommend the use of the assay MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in Serum/Plasma (order no. 62062) for chromatographic separation of the diastereomers and quantitation of 3-epi-25-OH-vitamin D3 to ensure correct assessment of the vitamin D status in patient samples that might contain 3-epi-25-OH-vitamin D3/D2.
Detailed performance evaluation data for this assay can be found in Appendices II and III of the instruction manual.
Content for 200 tests (62000)
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 (62000/1000)
Mobile Phase A, 1000 ml (5x)
Mobile Phase B, 1000 ml (5x)
Precipitation Reagent, 5 ml (5x)
Internal Standard, 40 ml (5x)
Rinsing Solution, 1000 ml (2x)
Reaction Vials, 100 pcs. (10x)
3PLUS1® 25-OH-Vitamin D3/D2 Multilevel Serum Calibrator Set (lyoph.), 1 ml (4x)
MassCheck® 25-OH-Vitamin D3/D2 Serum Control, Level I (lyoph.), 1 ml (5x)
MassCheck® 25-OH-Vitamin D3/D2 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: 1.0 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 | 5.0 or 6.0 min (depending on gradient system) |
| Injection Volume | ≤ 50 µl (mass spectrometer dependent) |
| Column Temperature | Analytical Column and Trap Column: +20 to +25 °C |
| Ionisation | APCI positive |
| MS/MS Mode | MRM |
| Parameters | 25-OH-Vitamin D2, 25-OH-Vitamin D3 |
| Order No. | MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma by LC-MS/MS |
| 62000 | Kit for 200 tests |
| 62000/1000 | 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) |
| 62001 | Mobile Phase A, 1000 ml (1x) |
| 62002 | Mobile Phase B, 1000 ml (1x) |
| 62003 | Precipitation Reagent, 5 ml (1x) |
| 62004 | Internal Standard, 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) |
| 62100 | Analytical Column, equilibrated, with test chromatogram, 1 pc. |
| 62110 | Trap Column, equilibrated, with test chromatogram, 1 pc. |
| 62028 | 3PLUS1® Multilevel Serum Calibrator Set 25-OH-Vitamin D3/D2, 4 x 1 ml (lyoph.) |
| 62039 | 6PLUS1® Multilevel Serum Calibrator Set 25-OH-Vitamin D3/D2, 7 x 1 ml (lyoph.) |
| 0222 | MassCheck® 25-OH-Vitamin D3/D2 Serum Control Level I, 5 x 1 ml (lyoph.) |
| 0223 | MassCheck® 25-OH-Vitamin D3/D2 Serum Control Level II, 5 x 1 ml (lyoph.) |
| 0256 | MassCheck® 25-OH-Vitamin D3/D2 Serum Control Level III, 5 x 1 ml (lyoph.) |
| 62015 | Tuning Mix 25-OH-Vitamin D3/D2, Analytes and Internal Standards, 2 ml |
| Order No. | Lab equipment |
| 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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Analytical Column 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MSOrder no.: 62100MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MS
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3PLUS1® Multilevel Serum Calibrator Set 25-OH-Vitamin D3/D2Order no.: 62028MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MS -
6PLUS1® Multilevel Serum Calibrator Set 25-OH-Vitamin D3/D2Order no.: 62039MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MS -
MassCheck® 25-OH-Vitamin D3/D2 Serum ControlsOrder no.: 0221/0222/0223/0256MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC/MS-MS
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Tuning Mix 25-OH-Vitamin D3/D2Order no.: 62015MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MS
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3PLUS1® Multilevel Serum Calibrator Set 25-OH-Vitamin D3/D2Order no.: 62028MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MS
-
6PLUS1® Multilevel Serum Calibrator Set 25-OH-Vitamin D3/D2Order no.: 62039MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MS
-
MassCheck® 25-OH-Vitamin D3/D2 Serum ControlsOrder no.: 0221/0222/0223/0256
MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC/MS-MS
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Analytical Column 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MSOrder no.: 62100
MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MS
25-OH-Vitamin D2
25-OH-Vitamin D3
MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma by LC-MS/MS
Kit for 200 tests (Order no. 62000)
Kit for 1000 tests, including Analytical Column, Trap Column, 3PLUS1® Multilevel Calibrator Set and MassCheck® Controls (Order no. 62000/1000)
Clinical relevance
This assay allows the quantitative determination of 25-hydroxycholecalciferol (25-OH-vitamin D3) and 25-hydroxyergocalciferol (25-OH-vitamin D2) 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 assay is further intended to be used as an aid to diagnosis of diseases for which determination of vitamin D levels is indicated.
Assay characteristics
Manual sample preparation is limited to simple and effective protein precipitation. A trap column concentrates the analytes and separates interfering substances. A two-position-six-port-valve connects the trap column to an HPLC column where the chromatographic separation takes place. The use of atmospheric pressure chemical ionisation (APCI) and a deuterated internal standard assures precision and robustness and minimises ion suppression effects.
This kit does not separate 3-epi-25-OH-vitamin D3 and 3-epi-25-OH-vitamin D2 from 25-OH-vitamin D3 and 25-OH-vitamin D2, respectively, and should therefore only be used to analyse samples that contain none or just negligible amounts of these metabolites.
We recommend the use of the assay MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in Serum/Plasma (order no. 62062) for chromatographic separation of the diastereomers and quantitation of 3-epi-25-OH-vitamin D3 to ensure correct assessment of the vitamin D status in patient samples that might contain 3-epi-25-OH-vitamin D3/D2.
Detailed performance evaluation data for this assay can be found in Appendices II and III of the instruction manual.
Content for 200 tests (62000)
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 (62000/1000)
Mobile Phase A, 1000 ml (5x)
Mobile Phase B, 1000 ml (5x)
Precipitation Reagent, 5 ml (5x)
Internal Standard, 40 ml (5x)
Rinsing Solution, 1000 ml (2x)
Reaction Vials, 100 pcs. (10x)
3PLUS1® 25-OH-Vitamin D3/D2 Multilevel Serum Calibrator Set (lyoph.), 1 ml (4x)
MassCheck® 25-OH-Vitamin D3/D2 Serum Control, Level I (lyoph.), 1 ml (5x)
MassCheck® 25-OH-Vitamin D3/D2 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: 1.0 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 | 5.0 or 6.0 min (depending on gradient system) |
| Injection Volume | ≤ 50 µl (mass spectrometer dependent) |
| Column Temperature | Analytical Column and Trap Column: +20 to +25 °C |
| Ionisation | APCI positive |
| MS/MS Mode | MRM |
| Parameters | 25-OH-Vitamin D2, 25-OH-Vitamin D3 |
| Order No. | MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma by LC-MS/MS |
| 62000 | Kit for 200 tests |
| 62000/1000 | 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) |
| 62001 | Mobile Phase A, 1000 ml (1x) |
| 62002 | Mobile Phase B, 1000 ml (1x) |
| 62003 | Precipitation Reagent, 5 ml (1x) |
| 62004 | Internal Standard, 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) |
| 62100 | Analytical Column, equilibrated, with test chromatogram, 1 pc. |
| 62110 | Trap Column, equilibrated, with test chromatogram, 1 pc. |
| 62028 | 3PLUS1® Multilevel Serum Calibrator Set 25-OH-Vitamin D3/D2, 4 x 1 ml (lyoph.) |
| 62039 | 6PLUS1® Multilevel Serum Calibrator Set 25-OH-Vitamin D3/D2, 7 x 1 ml (lyoph.) |
| 0222 | MassCheck® 25-OH-Vitamin D3/D2 Serum Control Level I, 5 x 1 ml (lyoph.) |
| 0223 | MassCheck® 25-OH-Vitamin D3/D2 Serum Control Level II, 5 x 1 ml (lyoph.) |
| 0256 | MassCheck® 25-OH-Vitamin D3/D2 Serum Control Level III, 5 x 1 ml (lyoph.) |
| 62015 | Tuning Mix 25-OH-Vitamin D3/D2, Analytes and Internal Standards, 2 ml |
| Order No. | Lab equipment |
| 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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Analytical Column 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MSOrder no.: 62100
MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MS
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3PLUS1® Multilevel Serum Calibrator Set 25-OH-Vitamin D3/D2Order no.: 62028MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MS
-
6PLUS1® Multilevel Serum Calibrator Set 25-OH-Vitamin D3/D2Order no.: 62039MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MS
-
MassCheck® 25-OH-Vitamin D3/D2 Serum ControlsOrder no.: 0221/0222/0223/0256
MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC/MS-MS
-
Tuning Mix 25-OH-Vitamin D3/D2Order no.: 62015
MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MS
-
3PLUS1® Multilevel Serum Calibrator Set 25-OH-Vitamin D3/D2Order no.: 62028MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MS
-
6PLUS1® Multilevel Serum Calibrator Set 25-OH-Vitamin D3/D2Order no.: 62039MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MS
-
MassCheck® 25-OH-Vitamin D3/D2 Serum ControlsOrder no.: 0221/0222/0223/0256
MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC/MS-MS
-
Analytical Column 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MSOrder no.: 62100
MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MS