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Preanalytical, analytical (DiaSorin LIAISON) and clinical variables potentially affecting the 25-OH vitamin D estimation.

Abstract：

BACKGROUND:Vitamin D (25-OHD) physiological functions have been expanded beyond traditional bone health, increasing the importance of its estimation in Laboratory Medicine, which renders validation of available methods mandatory. AIMS AND METHODS:We evaluated some preanalytical and analytical aspects of 25-OHD determination and the effects of potentially confounding clinical variables by using the DiaSorin "LIAISON 25-OH Vitamin D TOTAL". RESULTS:25-OHD samples were extremely stable, at least in the short term, without requiring special transport or storage. Precision intervals (CV%) were: within run (7-11%) and total precision (8-11.5%). Mean (SD) recovery was 96 (2)%. The assay was linear on dilution. Comparison with radioimmunoassay (RIA) yielded acceptable correlation (Inter-rater agreement/kappa coefficient=0.94) and clinical equivalence in the interval from 6 to 55 ng/mL. The assay was evaluated on a general population (N=476, age: 60±14 years, 65 males). The status of 25-OHD resulted inversely related to parathyroid hormone levels (r=-0.21, p<0.001), and aging (r=-0.17, p<0.001), but not to sex. Levels of 25-OHD were found to be sufficient (≥30 ng/mL) only in 54 samples (12%). Marked seasonal 25-OHD variations were observed in 13 subjects (p<0.05). Moreover, a marked seasonal fluctuation was seen in samples collected during the period of February 2010-October 2011 (p≤0.01). Lower 25-OHD concentration was observed in subjects with diabetes (19±9 vs 14±7 ng/mL, p<0.01) and hypertension (20±9 vs 17±9 ng/mL, p<0.01). Moreover, 25-OHD inversely correlated with BMI (r=-0.25, p<0.001). Conversely, no difference in 25-OHD levels was observed between subjects due to smoking habits and dyslipidemia. In multiple logistic regression models, aging is the only significant independent risk factor for low 25-OHD levels (Odds ratio, 95% confidence intervals: 3.1, 1.3-7.3; p≤0.01). CONCLUSIONS:Results confirm the LIAISON 25-OHD assay as a useful tool for 25-OHD estimation in the clinical practice. Lack of vitamin D is common among Italian adults, and appears associated with several cardiovascular risk factors.

journal_name

Clin Biochem

journal_title

Clinical biochemistry

authors

Bianchi S,Maffei S,Prontera C,Battaglia D,Vassalle C

doi

10.1016/j.clinbiochem.2012.08.003

subject

Has Abstract

pub_date

2012-12-01 00:00:00

pages

1652-7

issue

eissn

0009-9120

issn

1873-2933

pii

S0009-9120(12)00461-4

journal_volume

pub_type

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Preanalytical, analytical (DiaSorin LIAISON) and clinical variables potentially affecting the 25-OH vitamin D estimation.