Automated Competitive Protein-Binding Assay for Total 25-OH Vitamin D, Multicenter Evaluation and Practical Performance.

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

SUBMITTER: Wielders JP 

PROVIDER: S-EPMC6807057 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature