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.
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.
Authors: Christopher T Sempos; Annemieke C Heijboer; Daniel D Bikle; Jens Bollerslev; Roger Bouillon; Patsy M Brannon; Hector F DeLuca; Glenville Jones; Craig F Munns; John P Bilezikian; Andrea Giustina; Neil Binkley Journal: Br J Clin Pharmacol Date: 2018-07-17 Impact factor: 4.335
Authors: Stephen A Wise; Johanna E Camara; Carolyn Q Burdette; Grace Hahm; Federica Nalin; Adam J Kuszak; Joyce Merkel; Ramón A Durazo-Arvizu; Emma L Williams; Andrew N Hoofnagle; Fiona Ivison; Ralf Fischer; Jody M W van den Ouweland; Chung S Ho; Emmett W K Law; Jean-Nicolas Simard; Renaud Gonthier; Brett Holmquist; Sarah Meadows; Lorna Cox; Kimberly Robyak; Michael H Creer; Robert Fitzgerald; Michael W Clarke; Norma Breen; Pierre Lukas; Étienne Cavalier; Christopher T Sempos Journal: Anal Bioanal Chem Date: 2021-08-25 Impact factor: 4.142
Authors: Stephen A Wise; Johanna E Camara; Carolyn Q Burdette; Grace Hahm; Federica Nalin; Adam J Kuszak; Joyce Merkel; Ramón A Durazo-Arvizu; Emma L Williams; Christian Popp; Christian Beckert; Jan Schultess; Glen Van Slooten; Carole Tourneur; Camille Pease; Ravi Kaul; Alfredo Villarreal; Marcelo Cidade Batista; Heather Pham; Alex Bennett; Eugene Jansen; Dilshad Ahmed Khan; Mark Kilbane; Patrick J Twomey; James Freeman; Neil Parker; Sohail Mushtaq; Christine Simpson; Pierre Lukas; Étienne Cavalier; Christopher T Sempos Journal: Anal Bioanal Chem Date: 2021-08-25 Impact factor: 4.142
Authors: Barbara Altieri; Etienne Cavalier; Harjit Pal Bhattoa; Faustino R Pérez-López; María T López-Baena; Gonzalo R Pérez-Roncero; Peter Chedraui; Cedric Annweiler; Silvia Della Casa; Sieglinde Zelzer; Markus Herrmann; Antongiulio Faggiano; Annamaria Colao; Michael F Holick Journal: Eur J Clin Nutr Date: 2020-01-06 Impact factor: 4.016
Authors: E Cavalier; R Eastell; N R Jørgensen; K Makris; S Tournis; S Vasikaran; J A Kanis; C Cooper; H Pottel; H A Morris Journal: Calcif Tissue Int Date: 2021-03-04 Impact factor: 4.333
Authors: Konstantinos Makris; Harjit P Bhattoa; Etienne Cavalier; Karen Phinney; Christopher T Sempos; Candice Z Ulmer; Samuel D Vasikaran; Hubert Vesper; Annemieke C Heijboer Journal: Clin Chim Acta Date: 2021-03-10 Impact factor: 6.314