Analytical validation of the Roche 25-OH Vitamin D Total assay.

Author(s): Knudsen CS, Nexo E, Højskov CS, Heickendorff L

Publication: Clin Chem Lab Med, 2012, Vol. 50, Page 1965-8

PubMed ID: 23093282 PubMed Review Paper? No

Purpose of Paper

Conclusion of Paper

Studies

1. Study Purpose

   The purpose of this study was to compare 25(OH)D measurement in serum and plasma and to compare levels obtained using the Roche Vitamin D Total assay with those from LC-MS/MS. Specimens were stored at -80 degrees C until analysis.

   Summary of Findings:

   25(OH)D measurements in serum and lithium-heparin plasma were not significantly different as measured by the Roche Vitamin D Total assay. 25(OH)D3 measurements in serum were comparable and strongly correlated (r2=0.89) between the Roche assay and LC-MS/MS. However, 25(OH)D2 measurements in serum were significantly higher when measured by LC-MS/MS rather than the Roche assay (p<0.0001), although levels were very strongly correlated between measurement methods (r2=0.94).

   Biospecimens

   • Bodily Fluid - Plasma
   • Bodily Fluid - Serum
   • Bodily Fluid - Blood

   Preservative Types

   • Frozen

   Diagnoses:

   • Not specified

   Platform:

   Analyte	Technology Platform
   Small molecule	Clinical chemistry/auto analyzer
   Small molecule	LC-MS or LC-MS/MS

   Pre-analytical Factors:

   Classification	Pre-analytical Factor	Value(s)
   Biospecimen Aliquots and Components	Blood and blood products	Plasma Serum
   Biospecimen Acquisition	Type of collection container/solution	Serum gel tubes Lithium-heparin tubes
   Clinical chemistry/auto analyzer Specific	Technology platform	LC-MS/MS

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