The new Roche Vitamin D Total assay: fit for its purpose?

Author(s): Emmen JM, Wielders JP, Boer AK, van den Ouweland JM, Vader HL

Publication: Clin Chem Lab Med, 2012, Vol. 50, Page 1-4

PubMed ID: 22752789 PubMed Review Paper? No

Purpose of Paper

Conclusion of Paper

Studies

1. Study Purpose

   The purpose of this study was to compare the measurement of 25(OH)D in serum and plasma using the Roche Elecsys Vitamin D Total assay and to compare the results of this assay with LC-MS/MS, HPLC, and Liaison immunoassay measurements. Left-over serum specimens from three different laboratories that had been frozen at -20 degrees C were used. Each laboratory compared the Elecsys assay to one other measurement method. The Modular Analytics E170 and Cobas e601 analyzers were used for the Elecsys assay in different laboratories.

   Summary of Findings:

   Using the Elecsys assay, serum 25(OH)D levels were not significantly different from levels measured in heparinated plasma. 25(OH)D levels measured by the Elecsys assay and the Liaison immunoassay were strongly correlated (r=0.86), while those measured by the Elecsys assay and LC-MS/MS or HPLC were very strongly correlated (r=0.93 and r=0.91, respectively). The authors report that some individual specimens showed large between-method differences in 25(OH)D measurements.

   Biospecimens

   • Bodily Fluid - Serum
   • Bodily Fluid - Plasma

   Preservative Types

   • Frozen

   Diagnoses:

   • Not specified

   Platform:

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

   Pre-analytical Factors:

   Classification	Pre-analytical Factor	Value(s)
   Clinical chemistry/auto analyzer Specific	Technology platform	Modular Analytics E170 Cobas e601 LC MS/MS HPLC Immunoassay
   Biospecimen Aliquots and Components	Blood and blood products	Plasma Serum

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