title: Influence of Vitamin D Binding Protein on Accuracy of 25-Hydroxyvitamin D Measurement Using the ADVIA Centaur Vitamin D Total Assay.
abstract: Vitamin D status in different populations relies on accurate measurement of total serum 25-hydroxyvitamin D [25(OH)D] concentrations [i.e., 25(OH)D3 and 25(OH)D2]. This study evaluated agreement between the ADVIA Centaur Vitamin D Total assay for 25(OH)D testing (traceable to the NIST-Ghent reference method procedure) and a liquid chromatography tandem mass spectrometry (LC-MS/MS) method for various populations with different levels of vitamin D binding protein (DBP). Total serum 25(OH)D concentrations were measured for 36 pregnant women, 40 hemodialysis patients, and 30 samples (DBP-spiked or not) from healthy subjects. ELISA measured DBP levels. The mean serum DBP concentrations were higher for pregnancy (415 μg/mL) and lower for hemodialysis subjects (198 μg/mL) than for healthy subjects and were highest for spiked serum (545 μg/mL). The average bias between the ADVIA Centaur assay and the LC-MS/MS method was -1.4% (healthy), -6.1% (pregnancy), and 4.4% (hemodialysis). The slightly greater bias for samples from some pregnancy and hemodialysis subjects with serum DBP levels outside of the normal healthy range fell within a clinically acceptable range-reflected by analysis of their low-range (≤136 μg/mL), medium-range (137-559 μg/mL), and high-range (≥560 μg/mL) DBP groups. Thus, the ADVIA Centaur Vitamin D Total assay demonstrates acceptable performance compared with an LC-MS/MS method for populations containing different amounts of DBP.
authors.affiliation: Siemens Healthcare Diagnostics, 511 Benedict Avenue, Tarrytown, NY 10591, USA.
authors.forename: James
authors.initials: J
authors.lastname: Freeman
authors.affiliation: Siemens Healthcare Diagnostics, 511 Benedict Avenue, Tarrytown, NY 10591, USA.
authors.forename: Kimberly
authors.initials: K
authors.lastname: Wilson
authors.affiliation: Siemens Healthcare Diagnostics, 511 Benedict Avenue, Tarrytown, NY 10591, USA.
authors.forename: Ryan
authors.initials: R
authors.lastname: Spears
authors.affiliation: Siemens Healthcare Diagnostics, 511 Benedict Avenue, Tarrytown, NY 10591, USA.
authors.forename: Victoria
authors.initials: V
authors.lastname: Shalhoub
authors.affiliation: Siemens Healthcare Diagnostics, 511 Benedict Avenue, Tarrytown, NY 10591, USA.
authors.forename: Paul
authors.initials: P
authors.lastname: Sibley