Performance characteristics of the VIDAS 25-OH Vitamin D total assay - comparison with four immunoassays and two liquid chromatography-tandem mass spectrometry methods in a multicentric study
Moreau, E; Bächer, S; Mery, Set al.
2016 • In Clinical Chemistry and Laboratory Medicine
Performance characteristics of the VIDAS® 25-OH Vitamin D Total assay – comparison with four immunoassays and two liquid chromatography-tandem mass spectrometry methods in a multicentric study.pdf
assay performance; liquid chromatography/mass spectrometry; standardization; 25-OH vitamin D
Abstract :
[en] Background: The study was conducted to evaluate the
analytical and clinical performance of the VIDAS® 25-OH
Vitamin D Total assay. The clinical performance of the
assay was compared with four other immunoassays
against the results of two different liquid chromatography/
mass spectrometry methods (LC-MS/MS) standardized
to
NIST reference materials.
Methods: VIDAS® 25-OH Vitamin D Total assay precision,
linearity, detection limits and sample matrix comparison
were assessed following CLSI guidelines. For method
comparison, a total of 150 serum samples ranging from 7
to 92 ng/mL were analyzed by all the methods. Correlation
was studied using Passing-Bablok regression and Bland-
Altman analysis. The concordance correlation coefficient
(CCC) was calculated to evaluate agreement between
immunoassays and the reference LC-MS/MS method. In
addition, samples containing endogenous 25(OH)D2 were
used to assess each immunoassay’s ability to detect this
analyte. Pregnancy and hemodialysis samples were used
to the study the effect of vitamin D binding protein (DBP)
concentration over VIDAS® assay performance.
Results: The VIDAS® 25-OH Vitamin D Total assay
showed excellent correlation to the LC-MS/MS results
(y = 1.01x+0.22 ng/mL, r = 0.93), as obtained from two different
sites and distinct LC-MS/MS methods. The limit of
quantification was determined at 8.1 ng/mL. Cross-reactivity
for 25(OH)D2 was over 80%. At concentrations of
10.5, 26 and 65.1 ng/mL, within-run CVs were 7.9%, 3.6%
and 1.7%, while total CVs (between runs, calibrations, lots
and instruments) were 16.0%, 4.5% and 2.8%. The VIDAS®
performance was not influenced by altered DBP levels,
though under-recovery of 25(OH)D as compared to LC-MS/
MS was observed for hemodialysis samples.
Conclusions: The VIDAS® 25-OH Vitamin D Total assay is
therefore considered suitable for assessment of vitamin D
status in clinical routine.
Keywords: assay performance; liquid chromatography/
Disciplines :
Laboratory medicine & medical technology
Author, co-author :
Moreau, E
Bächer, S
Mery, S
Goff, CL
Piga, N
Vogeser, M
Hausmann, M
CAVALIER, Etienne ; Centre Hospitalier Universitaire de Liège - CHU > Chimie clinique
Language :
English
Title :
Performance characteristics of the VIDAS 25-OH Vitamin D total assay - comparison with four immunoassays and two liquid chromatography-tandem mass spectrometry methods in a multicentric study
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