Technical and clinical evaluation of the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Assay - comparison with marketed automated immunoassays and a liquid chromatography - tandem mass spectrometry method
assay performance; biais; concordance; precision; vitamin D
Abstract :
[en] Background: The study was conducted to evaluate the technical and clinical performance of the VITROS ® Immunodiagnostic Products 25-OH Vitamin D Total Assay, and compare it with the performance of five marketed automated assays and a liquid chromatography/mass spectrometry reference method (LC-MS/MS).
Methods: Three hundred patient serum samples were used to compare the correlation of the VITROS ® 25-OH Vitamin D Total Assay with both the other immunoassays and the LC-MS/MS method, using Passing-Bablok regression and Bland-Altman analyses. Concordance of the diagnosis of vitamin D status was calculated to test the agreement between the different assays. In addition, samples containing vitamin D2 were used to test the assay ’ s ability to detect the D2 form of the vitamin.
Results and conclusions: These results from the VITROS ® 5-OH Vitamin D Total Assay generally correlated well with those from most of the marketed immunoassays. Cross-reactivity of the D2 form was calculated as being close to 100%. Additionally, we found substantial variability in performance amongst the various assays, which suggests the need for optimisation and recalibration of commercial methods.
Disciplines :
Laboratory medicine & medical technology
Author, co-author :
CAVALIER, Etienne ; Centre Hospitalier Universitaire de Liège - CHU > Chimie médicale
ROUSSELLE, Olivier ; Centre Hospitalier Universitaire de Liège - CHU > Chimie médicale
FERRANTE, Nunzio ; Centre Hospitalier Universitaire de Liège - CHU > Chimie médicale
CARLISI, Ignazia ; Centre Hospitalier Universitaire de Liège - CHU > Chimie médicale
LE GOFF, Caroline ; Centre Hospitalier Universitaire de Liège - CHU > Chimie médicale
Souberbielle, Jean-Claude
Language :
English
Title :
Technical and clinical evaluation of the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Assay - comparison with marketed automated immunoassays and a liquid chromatography - tandem mass spectrometry method
scite shows how a scientific paper has been cited by providing the context of the citation, a classification describing whether it supports, mentions, or contrasts the cited claim, and a label indicating in which section the citation was made.
Bibliography
Norman AW, Bouillon R. Vitamin D nutritional policy needs a vision for the future [minireview]. Exp Biol Med 2010;235: 1034-5.
Rosen CJ. Clinical practice: vitamin D insufficiency. N Engl J Med 2011;364: 248-54.
Pitz S, Tomaschitz A, März W, Dreschler C, Ritz E, Zittermann A, et al. Vitamin D: cardiovascular disease and mortality (review). Clin Endocrinol 2011;75: 575-84.
Holick MF. Vitamin D: its role in cancer prevention and treatment (review). Prog Biophys Mol Biol 2006;92: 49-59. (Pubitemid 43831958)
Arnson Y, Amital H, Shoenfeld Y. Vitamin D and autoimmunity: the aetiological and therapeutic considerations. Ann Rheum Dis 2007;66: 1137-42. (Pubitemid 47309727)
Amital H, Szekanecz Z, Szücs G, Dankó K, Nagy E, Csépány T, et al. Serum concentrations of 25-OH vitamin D in patients with systemic lupus erythematosus (SLE) are inversely related to disease activity: is it time to routinely supplement patients with SLE with vitamin D? Ann Rheum Dis 2010;69: 1155-7.
Dusso AS, Brown AJ, Slatopolsky E. Vitamin D. Am J Physiol Renal Physiol 2005;289:F8-28.
Heaney BP. Vitamin D: how much do we need and how much is too much? Osteoporosis Int 2000;11: 553-5.
Holick MF, Biancuzzo RM, Chen TC, Klein EK, Young A, Bibuld D, et al. Vitamin D2 is as effective as vitamin D3 in maintaining circulating concentrations of 25-hydroxyvitamin D. J Clin Endocrinol Metab 2008;93: 677-81. (Pubitemid 351398538)
Farrell C-J, Martin S, McWhinney B, Straub I, Williams P, Herrmann M. State-of-the art vitamin D assays: a comparison of automated immunoassays with liquid chromatographytandem mass spectrometry methods. Clin Chem 2012;58: 531-42.
Le Goff C, Peeters S, Crine Y, Luks P, Souberbielle JC, Cavalier E. Evaluation of the cross-reactivity of 25-hydroxyvitamin D2 on seven commercial immunoassays on native samples. Clin Chem Lab Med 2012;50: 2031-2.
Cavalier E, Wallace AM, Carlisi A, Chapelle JP, Delanaye P, Souberbielle JC. Cross-reactivity of 25-hydroxy vitamin D2 from different commercial immunoassays for 25-hydroxy vitamin D: an evaluation without spiked samples. Clin Chem Lab Med 2011;49: 555-8.
Thienpont LM, Stepman HC, Vesper HW. Standardization of measurements of 25-Hydroxyvitamin D3 and D2. Scand J Clin Lab Invest 2012;72: 41-9.
Sempos CT, Vesper HW, Phinney KW, Thienpont LM, Coates PM. Vitamin D status as an international issue: national surveys and the problem of standardization. Scand J Clin Lab Invest 2012;72:32-40.
Similar publications
Sorry the service is unavailable at the moment. Please try again later.
This website uses cookies to improve user experience. Read more
Save & Close
Accept all
Decline all
Show detailsHide details
Cookie declaration
About cookies
Strictly necessary
Performance
Strictly necessary cookies allow core website functionality such as user login and account management. The website cannot be used properly without strictly necessary cookies.
This cookie is used by Cookie-Script.com service to remember visitor cookie consent preferences. It is necessary for Cookie-Script.com cookie banner to work properly.
Performance cookies are used to see how visitors use the website, eg. analytics cookies. Those cookies cannot be used to directly identify a certain visitor.
Used to store the attribution information, the referrer initially used to visit the website
Cookies are small text files that are placed on your computer by websites that you visit. Websites use cookies to help users navigate efficiently and perform certain functions. Cookies that are required for the website to operate properly are allowed to be set without your permission. All other cookies need to be approved before they can be set in the browser.
You can change your consent to cookie usage at any time on our Privacy Policy page.