Diasorin Vitamin D Assay

Diasorin Vitamin D Assay

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Performance evaluation of four 25-hydroxyvitamin D assays to measure 25-hydroxyvitamin D₂

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open access

Highlights

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Six month supplementation with 25(OH)D₂ led to 25(OH)D₂/25(OH)D₃ ratio of 1:1.

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We evaluated four immunoassays to measure equimolar 25(OH)D₂ and 25(OH)D₃.

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Siemens, DiaSorin, Roche and Abbott immunoassays show acceptable bias to LC-MS/MS.

Abstract

Objectives

The ability of current immunoassays to accurately measure equimolar amounts of 25(OH)D₂ and 25(OH)D₃ has been recently questioned. This study determined serum 25(OH)D₂, 25(OH)D₃ and total serum 25(OH)D concentrations in healthy vitamin D₂-supplemented subjects by isotope dilution liquid chromatography mass spectrometry (ID-LC-MS/MS); and, evaluated the ability of the Siemens, DiaSorin, Roche, and Abbott Vitamin D Total assays to monitor total serum 25(OH)D concentrations compared to an ID-LC-MS/MS method traceable to the National Institute of Standards and Technology (NIST), and that has achieved certification from the Centers for Disease Control and Prevention (CDC) Vitamin D Standardization Certification Program (VDSCP).

Design and methods

Twenty (20) healthy adults, with no history of prior vitamin D supplementation were administered oral vitamin D₂ (2400   IU/day for 6   months). Serum samples (140) from baseline and monthly blood draws were tested.

Results

After one month, the mean serum 25(OH)D₂ concentrations rose from 0.8 to 43.6   nmol/L, whereas 25(OH)D₃ concentrations declined from 84.0 to 63.4   nmol/L; total serum 25(OH)D concentrations rose from 86.6 to 107.0   nmol/L. The overall mean bias to ID-LC-MS/MS was −   7.1% for the Siemens ADVIA Centaur assay, −   15.3% for the DiaSorin LIAISON assay; −   8.4% for the Roche ELECSYS assay and −   16.3% for the Abbott ARCHITECT assay. Correlation coefficients (r) were 0.94, 0.79, 0.74, and 0.73; the mean bias for baseline [25(OH) D₃-containing] versus six-month [25(OH)D₂- and 25(OH)D₃-containing] samples was −   13.4% and −   5.7%; −   3.5% and 20.3%, 9.6% and −   12.1%, and 0.2% and −   17.8%, respectively.

Conclusions

The bias results obtained for the Siemens ADVIA Centaur assay and Roche ELECSYS assay were slightly lower than those for the DiaSorin LIAISON assay and the Abbott ARCHITECT assay, but all 25(OH)D assays demonstrated acceptable performance.

Keywords

Vitamin D total assay

ID-LC-MS/MS

VDSCP

25 Hydroxyvitamin D

Vitamin D

25(OH)D

25(OH)D₃

25(OH)D₂

Copyright © 2015 The Canadian Society of Clinical Chemists. Published by Elsevier Inc.

Diasorin Vitamin D Assay

Source: https://www.sciencedirect.com/science/article/pii/S000991201500212X