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ABSTRACT: Background
The Roche Elecsys Vitamin D Total competitive protein-binding assay uses recombinant vitamin D binding protein for measuring 25-hydroxyvitamin D (25-OHD), which is different from commonly used antibody assays.Methods
The assay, standardized against LC-MS/MS, was tested at four sites. Evaluation included precision; between-laboratory variability; functional sensitivity; correlation to LC-MS/MS, HPLC, and immunoassays; as well as robustness, traceability, and EQAS performance.Results
Precision testing showed within-run coefficient of variations (CVs) of ? 7%, within-laboratory CVs of <9.5%, between-laboratory precision CVs of ? 10.1%, and a functional sensitivity below 9.8 nmol/l (at CV 12.9%). The assay showed equivalent 25-OHD levels for matched serum and plasma samples, good reagent lot-to-lot consistency in pooled sera over time, and good agreement with HPLC (relative bias -8.8%). Comparison with LC-MS/MS methods yielded relative biases of -15.4, -13.5, -10.2, and 3.2%. Comparison against immunoassays showed a relative bias of 14.5% (DiaSorin Liaison) and -58.2% (IDS-iSYS). The overall mean results in 2 years DEQAS was 102% of the ALTM. In a certified reference patient panel, the average bias was < 4% for the sum of 25-OHD2 and 25-OHD3.Conclusion
The Elecsys Vitamin D Total assay demonstrated good overall performance and is, according to present standards, very suitable for automated measurement of 25-OHD.
SUBMITTER: Wielders JP
PROVIDER: S-EPMC6807057 | biostudies-literature | 2015 Nov
REPOSITORIES: biostudies-literature
Wielders Jos P M JP Carter Graeme F GF Eberl Heike H Morris Gary G Roth Heinz Jürgen HJ Vogl Christian C
Journal of clinical laboratory analysis 20140817 6
<h4>Background</h4>The Roche Elecsys Vitamin D Total competitive protein-binding assay uses recombinant vitamin D binding protein for measuring 25-hydroxyvitamin D (25-OHD), which is different from commonly used antibody assays.<h4>Methods</h4>The assay, standardized against LC-MS/MS, was tested at four sites. Evaluation included precision; between-laboratory variability; functional sensitivity; correlation to LC-MS/MS, HPLC, and immunoassays; as well as robustness, traceability, and EQAS perfor ...[more]