Analytical and clinical evaluation of the new Fujirebio Lumipulse(r)G non-competitive assay for 25(OH)-Vitamin D and three immunoassays for 25(OH)D in healthy subjects, osteoporotic patients, third trimester pregnant women, healthy African subjects, hemodialyzed and intensive care patients

Clinical Chemistry and Laboratory Medicine

Volumn 54, Issue 8, 2016, Pages 1347-1355

  Cavalier, Etienne ^a   Lukas, Pierre ^a   Bekaert, Anne Catherine ^a   Peeters, Stephanie ^a   Le Goff, Caroline ^a   Yayo, Eric ^a,b   Delanaye, Pierre ^a   Souberbielle, Jean Claude ^c  

^a UNIVERSITY OF LIÈGE   (Belgium)

^b UNIVERSITÉ FÉLIX HOUPHOUËT BOIGNY   (Côte d’Ivoire)

^c HÔPITAL NECKER ENFANTS MALADES   (France)

Author keywords

Assay performance; concordance; immunoassay; LC MS MS; Vitamin D

Indexed keywords

25 HYDROXYVITAMIN D; 25-HYDROXYVITAMIN D; VITAMIN D;

AFRICAN; ARTICLE; CORRELATION COEFFICIENT; CRITICALLY ILL PATIENT; EPIMER; EVALUATION STUDY; FEMALE; HEMODIALYSIS PATIENT; HUMAN; IMMUNOASSAY; IMMUNOASSAY ANALYZER; INTENSIVE CARE UNIT; INTERMETHOD COMPARISON; LIMIT OF QUANTITATION; LIQUID CHROMATOGRAPHY; MEASUREMENT ACCURACY; NORMAL HUMAN; OSTEOPOROSIS; PREGNANT WOMAN; PRIORITY JOURNAL; TANDEM MASS SPECTROMETRY; THIRD TRIMESTER PREGNANCY; ANALOGS AND DERIVATIVES; BLACK PERSON; BLOOD; CAUCASIAN; HEMODIALYSIS; INTENSIVE CARE; PREGNANCY;

AFRICAN CONTINENTAL ANCESTRY GROUP; CHROMATOGRAPHY, LIQUID; CRITICAL CARE; EUROPEAN CONTINENTAL ANCESTRY GROUP; FEMALE; HEALTHY VOLUNTEERS; HUMANS; IMMUNOASSAY; OSTEOPOROSIS; PREGNANCY; PREGNANCY TRIMESTER, THIRD; RENAL DIALYSIS; TANDEM MASS SPECTROMETRY; VITAMIN D;

EID: 84978419918     PISSN: 14346621     EISSN: 14374331     Source Type: Journal    
DOI: 10.1515/cclm-2015-0923     Document Type: Article

References (27)

1. Farrell C-J, Soldo J, McWhinney B, Bandodkar S, Herrmann M. Impact of assay design on test performance: lessons learned from 25-hydroxyvitamin D. Clin Chem Lab Med 2014;52:1579-87.
2. Farrell C, Soldo J, Williams P, Herrmann M. 25-hydroxyvitamin D testing: challenging the performance of current automated immunoassays. Clin Chem Lab Med 2012;50:1953-63.
3. Wallace AM, Gibson S, de la 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.
4. Powe CE, Evans MK, Wenger J, Zonderman AB, Berg AH, Nalls M, et al. Vitamin D-binding protein and vitamin D status of black Americans and white Americans. N Engl J Med 2013;369:1991-2000.
5. Depreter B, Heijboer AC, Langlois MR. Accuracy of three automated 25-hydroxyvitamin D assays in hemodialysis patients. Clin Chim Acta 2013;415:255-60.
6. 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.
7. Cavalier E, Lukas P, Crine Y, Peeters S, Carlisi A, Le Goff C, et al. Evaluation of automated immunoassays for 25(OH)-vitamin D determination in different critical populations before and after standardization of the assays. Clin Chim Acta 2014;431:60-5.
8. Cavalier E, Wallace AM, Carlisi A, Chapelle J-P, Delanaye P, Souberbielle J-C. 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.
9. Kobold U. Approaches to measurement of vitamin D concentrations-mass spectrometry. Scand J Clin Lab Invest Suppl 2012;243:54-9.
10. Cavalier E, Carlisi A, Bekaert A-C, Rousselle O, Chapelle JP. Human anti-animal interference in DiaSorin Liaison total 25(OH)-vitamin D assay: towards the end of a strange story Clin Chim Acta 2012;413:527-8.
11. 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 Suppl 2012;243:32-40.
12. Holick MF. Vitamin D deficiency. N Engl J Med 2007;357: 266-81.
13. Omi K, Ando T, Sakyu T, Shirakawa T, Uchida Y, Oka A, et al. Noncompetitive immunoassay detection system for haptens on the basis of antimetatype antibodies. Clin Chem 2015;61:627-35.
14. NCCLS. Evaluation of precision performance of quantitative measurement methods, approved guideline, EP05-A2, ISBN 1-56238-542-9. n.d.
15. Rousseau A-F, Damas P, Janssens M, Kalin S, Ledoux D, Le Goff C, et al. Critical care and vitamin D status assessment: what about immunoassays and calculated free 25OH-D Clin Chim Acta 2014;437:43-7.
16. Wielders JP, Wijnberg FA. Preanalytical stability of 25(OH)-vitamin D3 in human blood or serum at room temperature: solid as a rock. Clin Chem 2009;55:1584-5.
17. Lin LI. A concordance correlation coefficient to evaluate reproducibility. Biometrics 1989;45:255-68.
18. Mcbride GB. A proposal for strength-of-agreement criteria for Lin's Concordance Correlation Coefficient. NIWA Client Rep 2005;HAM2005-06:14.
19. Binkley N, Sempos CT. Standardizing vitamin D assays: the way forward. J Bone Miner Res 2014;29:1709-14.
20. Le Goff C, Peeters S, Crine Y, Lukas 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.
21. Van den Ouweland JM, Beijers AM, van Daal H, Elisen MG, Steen G, Wielders JP. Evaluation of 3-epi-25-hydroxyvitamin D3 cross-reactivity in the Roche Elecsys Vitamin D total protein binding assay. Clin Chem Lab Med 2014;52:373-80.
22. Durup D, Jørgensen HL, Christensen J, Schwarz P, Heegaard AM, Lind B. A reverse J-shaped association of all-cause mortality with serum 25-hydroxyvitamin D in general practice: the CopD study. J Clin Endocrinol Metab 2012;97:2644-52.
23. Sanders KM, Stuart AL, Williamson EJ, Simpson JA, Kotowicz MA, Young D, et al. Annual high-dose oral vitamin D and falls and fractures in older women: a randomized controlled trial. J Am Med Assoc 2010;303:1815-22.
24. Moreau E, Bächer S, Mery S, Goff CL, Piga N, Vogeser M, et al. 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. Clin Chem Lab Med 2016;54:45-53.
25. Chun RF, Peercy BE, Orwoll ES, Nielson CM, Adams JS, Hewison M. Vitamin D and DBP: the free hormone hypothesis revisited. J Steroid Biochem Mol Biol 2013;144:132-7.
26. Bouillon R, Van Assche FA, Van Baelen H, Heyns W, De Moor P. Influence of the vitamin D-binding protein on the serum concentration of 1,25-dihydroxyvitamin D3. Significance of the free 1,25-dihydroxyvitamin D3 concentration. J Clin Invest 1981;67:589-96.
27. Cooke NE, Haddad JG. Vitamin D binding protein (Gc-globulin). Endocr Rev 1989;10:294-307.