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

Abstract

Background: Measurement of serum 25-hydroxyvitamin D [25(OH)D] is used to assess vitamin D status. We evaluated the analytical performance of a new automated assay, Elecsys Vitamin D Total (Roche Diagnostics, Mannheim, Germany), based on competitive protein binding. Methods: The Elecsys assay was tested for imprecision, linearity and functional sensitivity at three test-sites and compared to a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, a high-performance liquid chromatography (HPLC) method and the Liaison 25(OH) Vitamin D Total immunoassay (Diasorin). Results: Imprecision testing with human serum specimens showed within-run CVs of ≤6% and between-run CVs of ≤8%. The assay was linear from 33 up to at least 111 nmol/L and showed equivalent 25(OH)D levels for matched serum and heparinized plasma samples. The assay correlated reasonable to well with LC-MS/MS (r=0.93; y=1.07x-5.04 nmol/L), HPLC (r=0.91, y=0.90x+3.03 nmol/L) and the Liaison assay (r=0.86, y=1.19x+2.80 nmol/L). Some of the samples showed large between-method differences. Conclusions: The new Elecsys assay fulfilled present analytical performance requirements and showed close agreement to other well-established methods for 25(OH)D analysis, making it fit for routine assessment of vitamin D status.

Association between vitamin D level and viral load or fibrosis stage in chronic hepatitis B patients from Southern China

“…Recent study of imprecision test for Elecsys assay showed that it correlated well with LC-MS/MS (r = 0.93), HPLC (r = 0.91), and the Liaison assay (r = 0.86), indicating an excellent agreement. 16 In light of this close agreement, it appears unlikely that different methods of VD measurement affect the main findings of these studies. The third limitation is that most studies were performed in one single center; negative findings in our study therefore highlighted a new insight that results may vary in different populations and settings.…”

“…Serum levels of 25(OH)D were measured using an automated electrochemiluminescence-based assay, Elecsys Vitamin D Total (Roche Diagnostics, Mannheim, Germany). 16 The data are expressed as nanograms per milliliter. 25(OH)D concentrations < 20 and < 30 ng/mL were defined as deficiency and insufficiency, respectively, while concentrations ≥ 30 ng/mL were considered to indicate sufficient VD.…”

Severe vitamin D deficiency is common in critically ill patients at a high northern latitude

“…25(OH)D was measured in the serum of every participating patient, using Elecsys â Vitamin D total assay by Roche Diagnostics, an electro-chemiluminescence binding assay, as previously described. 16…”

Vitamin D and omega-3 polyunsaturated fatty acid supplementation in athletes with exercise-induced bronchoconstriction: a pilot study

“…The Elecsys Total 25-hydroxyvitamin D assay (Roche Diagnostics GmbH, Germany) was used for the quantative determination of total serum 25-hydroxyvitamin D (25(OH)D) (nmol/L) [34]. Intra-assay coefficient of variation was <10%.…”