Analytical validation of the Roche 25-OH Vitamin D Total assay

Clinical Chemistry and Laboratory Medicine

Volumn 50, Issue 11, 2012, Pages 1965-1968

  Knudsen, Cindy Soendersoe ^a   Nexo, Ebba ^a   Højskov, Carsten Schriver ^a   Heickendorff, Lene ^a  

^a AARHUS UNIVERSITY HOSPITAL   (Denmark)

Author keywords

25 hydroxyvitamin D; Assay precision; Assay validation; Method comparison

Indexed keywords

25 HYDROXYVITAMIN D;

ANALYTIC METHOD; ANALYTICAL RESEARCH; ARTICLE; CONTROLLED STUDY; HUMAN; LIMIT OF QUANTITATION; LIQUID CHROMATOGRAPHY; MAJOR CLINICAL STUDY; PRIORITY JOURNAL; ROCHE 25 OH VITAMIN D TOTAL ASSAY; TANDEM MASS SPECTROMETRY; VITAMIN BLOOD LEVEL; VITAMIN DEFICIENCY;

BLOOD CHEMICAL ANALYSIS; HUMANS; REFERENCE STANDARDS; VITAMIN D;

EID: 84872926904     PISSN: 14346621     EISSN: 14374331     Source Type: Journal    
DOI: 10.1515/cclm-2011-0964     Document Type: Article

References (17)

1. Holick MF. Vitamin D deficiency. N Engl J Med 2007;357:266-81.
2. Holick MF. Vitamin D status: measurement, interpretation, and clinical application. Ann Epidemiol 2009;19:73-8.
3. Højskov CS, Heickendorff L, Møller HJ. High-throughput liquid-liquid extraction and LCMSMS assay for determination of circulating 25(OH) vitamin D3 and D2 in the routine clinical laboratory. Clinica Chimica Acta 2010;411:114-6.
4. Wallace AM, Gibson S, Hunty A, Lamberg-Allardt C, Ashwell M. Measurement of 25-hydroxyvitamin D in the clinical laboratory: current procedures, performance, characteristics and limitations. Steroids 2010;75:477-88.
5. National Institute of Standards and Technology, SRM 972 - Vitamin D in human Serum. Accessed December 30, 2011 Available from: http://www.nist.gov/ts/ msd/srm.
6. NCCLS. Evaluation of precision performance of quantitative measurement methods; approved guideline, EP05-A2; ISBN 1-56238-542-9.
7. NCCLS. Protocols for determination of limits of detection and limits of quantitation; approved guideline EP17-A; ISBN 1-56238-551-8.
8. Vogeser M, Kyriatsoulis A, Huber E, Kobold U. Candidate reference method for the quantification of circulating 25-hydroxyvitamin D 3 by liquid chromatography-tandem mass spectrometry. Clin Chem 2004;50:1415-7.
9. 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.
10. Carter GD, Jones JC, Berry JL. The anomalous behaviour of exogenous 25-hydroxyvitamin D in competitive binding assays. J Steroid Biochem Mol Biol 2007;103:480-2.
11. Horst RL. Exogenous versus endogenous recovery of 25-hydroxyvitamin D 2 and D 3 in human samples using highperformance liquid chromatography and the DiaSorin LIAISON Total-D Assay. J Steroid Biochem Mol Biol 2010;121: 180-2.
12. Kawakami M, Imawari M, Goodman DS. Quantitative studies of the interaction of cholecalciferol (vitamin D3) and its metabolites with different genetics variants of the serum binding protein for these sterols. Biochem J 1979;179:413-23.
13. Teegarden D, Meredith SC, Sitrin MD. Determination of the affinity of vitamin D metabolites to serum vitamin D binding protein using assay employing lipid-coated polystyrene beads. Anal Biochem 1991;199:293-9.
14. Arnaud J, Constans J. Affinity differences for vitamin D metabolites associated with the genetics isoforms of the human serum carrier protein (DBP). Hum Genet 1993;92:183-8.
15. Heijboer AC, Blankenstein MA, Kema IP, Buijs MM. Accuracy of 6 routine 25-hydroxyvitamin D assays: influence of vitamin D binding protein concentration. Clin Chem 2012;58:543-8.
16. Carter GD. 25-Hydroxyvitamin D: a difficult analyte. Clin Chem 2012;58:486-8.
17. 2) as a vitamin supplement. Am J Clin Nutr 2006;84:694-7.