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

Order No.: 62000/1000/F, for 1000 tests
Parameters:
25-OH-Vitamin D2, 25-OH-Vitamin D3

For sample preparation with 96 Well Filter Plates

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 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) 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.

 

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.

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: 1.0 µg/l – 250 µg/l
25-OH-Vitamin D2: 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 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 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
The following components are included in the kit:
General lab equipment (non-CE-IVD products), available from Chromsystems:
As a customer please login or register to gain full access.

25-OH-Vitamin D2

25-OH-Vitamin D3

MassChrom® 25-OH-Vitamin D3/D2 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) 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.

 

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.

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: 1.0 µg/l – 250 µg/l
25-OH-Vitamin D2: 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 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 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
The following components are included in the kit:
General lab equipment (non-CE-IVD products), available from Chromsystems:
As a customer please login or register to gain full access.