MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in Serum/Plasma - LC-MS/MS

Order No.: 62062/1000/F, for 1000 tests
Parameters:
25-OH-Vitamin D2, 25-OH-Vitamin D3, 3-epi-25-OH-Vitamin D3

For sample preparation with 96 Well Filter Plates

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 1000 tests, including Analytical Column, Trap Column, 3PLUS1® Multilevel Calibrator Set and MassCheck® Controls
For sample preparation with 96 Well Filter Plates

 

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.

More Information
Method of Analysis LC-MS/MS
Number of Tests 1000
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
25-OH-Vitamin D2: 1.5 µg/l – 250 µg/l
3-epi-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 96 well filter plates:

  • Pipette 200 µl Internal Standard into 96 well filter plate.
  • Add 25 µl Precipitation Reagent.
  • Add 100 µl sample/calibrator/MassCheck® control and shake 10 min.
  • Place 96 well filter plate on collection plate.
  • Centrifuge 5 min at 2000 x g.
  • Seal collection plate and transfer to autosampler.
  • Inject ≤ 50 µl eluate into the LC-MS/MS system
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

MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in Serum/Plasma by LC-MS/MS

Kit for 1000 tests, including Analytical Column, Trap Column, 3PLUS1® Multilevel Calibrator Set and MassCheck® Controls
For sample preparation with 96 Well Filter Plates

 

Order No. Kit components (Quantities in kit)
62011 Mobile Phase A, 1000 ml (5x)
62022 Mobile Phase B, 1000 ml (5x)
62003 Precipitation Reagent, 5 ml (5x)
62045 Internal Standard Mix, 40 ml (5x)
62009 Rinsing Solution, 1000 ml (2x)
62057 96 Well Filter Plates, 3 pcs. (4x)
62058 96 Well Collection Plates, 3 pcs. (4x)
62059 Pierceable Adhesive Seals for 96 Well Plates, 3 pcs. (4x)
62130 Analytical Column, equilibrated, with test chromatogram, 1 pc. (1x)
62110/epi Trap Column, equilibrated, with test chromatogram, 1 pc. (2x)
62029 3PLUS1® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 Multilevel Serum Calibrator Set (lyoph.), 1 ml (4x)
0311 MassCheck® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 Serum Control, Level I (lyoph.), 1 ml (5x)
0312 MassCheck® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 Serum Control, Level II (lyoph.), 1 ml (5x)

 

Order No. Required components (not included in the kit)
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)
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:
As a customer please login or register to gain full access.

MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in Serum/Plasma by LC-MS/MS

Kit for 1000 tests, including Analytical Column, Trap Column, 3PLUS1® Multilevel Calibrator Set and MassCheck® Controls
For sample preparation with 96 Well Filter Plates

 

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.

More Information
Method of Analysis LC-MS/MS
Number of Tests 1000
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
25-OH-Vitamin D2: 1.5 µg/l – 250 µg/l
3-epi-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 96 well filter plates:

  • Pipette 200 µl Internal Standard into 96 well filter plate.
  • Add 25 µl Precipitation Reagent.
  • Add 100 µl sample/calibrator/MassCheck® control and shake 10 min.
  • Place 96 well filter plate on collection plate.
  • Centrifuge 5 min at 2000 x g.
  • Seal collection plate and transfer to autosampler.
  • Inject ≤ 50 µl eluate into the LC-MS/MS system
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

MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in Serum/Plasma by LC-MS/MS

Kit for 1000 tests, including Analytical Column, Trap Column, 3PLUS1® Multilevel Calibrator Set and MassCheck® Controls
For sample preparation with 96 Well Filter Plates

 

Order No. Kit components (Quantities in kit)
62011 Mobile Phase A, 1000 ml (5x)
62022 Mobile Phase B, 1000 ml (5x)
62003 Precipitation Reagent, 5 ml (5x)
62045 Internal Standard Mix, 40 ml (5x)
62009 Rinsing Solution, 1000 ml (2x)
62057 96 Well Filter Plates, 3 pcs. (4x)
62058 96 Well Collection Plates, 3 pcs. (4x)
62059 Pierceable Adhesive Seals for 96 Well Plates, 3 pcs. (4x)
62130 Analytical Column, equilibrated, with test chromatogram, 1 pc. (1x)
62110/epi Trap Column, equilibrated, with test chromatogram, 1 pc. (2x)
62029 3PLUS1® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 Multilevel Serum Calibrator Set (lyoph.), 1 ml (4x)
0311 MassCheck® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 Serum Control, Level I (lyoph.), 1 ml (5x)
0312 MassCheck® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 Serum Control, Level II (lyoph.), 1 ml (5x)

 

Order No. Required components (not included in the kit)
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)
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:
As a customer please login or register to gain full access.