Performance characteristics of six automated 25-hydroxyvitamin D assays: Mind your 3s and 2s

Clinical Biochemistry

Volumn 48, Issue 16-17, 2015, Pages 1089-1096

  Wyness, Sara P ^a   Straseski, Joely A ^a,b  

^a ARUP INSTITUTE FOR CLINICAL AND EXPERIMENTAL PATHOLOGY   (United States)

^b UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

Author keywords

25 Hydroxyvitamin D; Accuracy; Correlation; Method comparison; Standardization; Vitamin D; Vitamin D deficiency

Indexed keywords

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

ADULT; ANALYTICAL PARAMETERS; ARTICLE; AUTOMATION; CALIBRATION; COMPARATIVE STUDY; FEMALE; HUMAN; IMMUNOASSAY; IMMUNOASSAY ANALYZER; INTERMETHOD COMPARISON; LIMIT OF BLANK; LIQUID CHROMATOGRAPH; LIQUID CHROMATOGRAPHY; MAJOR CLINICAL STUDY; MALE; MASS SPECTROMETER; MASS SPECTROMETRY; MEASUREMENT ACCURACY; PRIORITY JOURNAL; VITAMIN BLOOD LEVEL; ANALOGS AND DERIVATIVES; BIOASSAY; BLOOD; CHEMISTRY; MIDDLE AGED; PROCEDURES; STANDARD; TANDEM MASS SPECTROMETRY;

AUTOMATION; BIOLOGICAL ASSAY; CHROMATOGRAPHY, LIQUID; FEMALE; HUMANS; IMMUNOASSAY; MALE; MIDDLE AGED; REFERENCE STANDARDS; TANDEM MASS SPECTROMETRY; VITAMIN D;

EID: 84946401443     PISSN: 00099120     EISSN: 18732933     Source Type: Journal    
DOI: 10.1016/j.clinbiochem.2015.08.005     Document Type: Article

References (32)

1. Thacher T.D., Clarke B.L. Vitamin D insufficiency. Mayo Clin. Proc. 2011, 86:50-60.
2. DeLuca H.F. Overview of general physiologic features and functions of vitamin D. Am. J. Clin. Nutr. 2004, 80:1689S-1696S.
3. Rosen C.J., Adams J.S., Bikle D.D., Black D.M., Demay M.B., Manson J.E., et al. The nonskeletal effects of vitamin D: an Endocrine Society scientific statement. Endocr. Rev. 2012, 33:456-492.
4. Holick M.F. Vitamin D, deficiency. N. Engl. J. Med. 2007, 357:266-281.
5. Siemens Advia Centaur® XP: Recalibration of the Vitamin D Total Assay Beginning With Reagent Lot 134020 2012, (Tarrytown, NY).
6. Kushnir M.M., Ray J.A., Rockwood A.L., Roberts W.L., La'ulu S.L., Whittington J.E., et al. Rapid analysis of 25-hydroxyvitamin D(2) and D(3) by liquid chromatography-tandem mass spectrometry and association of vitamin D and parathyroid hormone concentrations in healthy adults. Am. J. Clin. Pathol. 2010, 134:148-156.
7. Owen W.E., Roberts W.L. Performance characteristics of the IMMULITE 2000 erythropoietin assay. Clin. Chim. Acta 2004, 340:213-217.
8. CLSI Interference testing in clinical chemistry; approved guideline. CLSI Document EP07-A2 2005, Clinical and Laboratory Standards Institute, Wayne, PA. Second Edition.
9. Landis J.R., Koch G.G. The measurement of observer agreement for categorical data. Biometrics 1977, 33:159-174.
10. Holick M.F., Binkley N.C., Bischoff-Ferrari H.A., Gordon C.M., Hanley D.A., Heaney R.P., et al. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society Clinical Practice Guideline. J. Clin. Endocrinol. Metab. 2011, 96:1911-1930.
11. Hollis B.W. Measuring 25-hydroxyvitamin D in a clinical environment: challenges and needs. Am. J. Clin. Nutr. 2008, 88:507S-510S.
12. Ong L., Saw S., Sahabdeen N.B., Tey K.T., Ho C.S., Sethi S.K. Current 25-hydroxyvitamin D assays: do they pass the test?. Clin. Chim. Acta 2012, 413:1127-1134.
13. Schottker B., Jansen E.H., Haug U., Schomburg L., Kohrle J., Brenner H. Standardization of misleading immunoassay based 25-hydroxyvitamin D levels with liquid chromatography tandem-mass spectrometry in a large cohort study. PLoS One 2012, 7:e48774.
14. Wallace A.M., 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, 75:477-488.
15. Chen Y., Kinney L., Bozovic A., Smith H., Tarr H., Diamandis E.P., et al. Performance evaluation of Siemens ADVIA Centaur and Roche MODULAR Analytics E170 Total 25-OH Vitamin D assays. Clin. Biochem. 2012, 45:1485-1490.
16. Hsu S.A., Soldo J., Gupta M. Evaluation of two automated immunoassays for 25-OH vitamin D: comparison against LC-MS/MS. J. Steroid Biochem. Mol. Biol. 2013, 136:139-145.
17. Moon H.W., Cho J.H., Hur M., Song J., Oh G.Y., Park C.M., et al. Comparison of four current 25-hydroxyvitamin D assays. Clin. Biochem. 2012, 45:326-330.
18. CLSI Hemolysis, icterus, and lipemia/turbidity indices as indicators of interference in clinical laboratory analysis; approved guideline. CLSI Document C56-A 2012, Clinical and Laboratory Standards Institute, Wayne, PA.
19. 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 chromatography-tandem mass spectrometry methods. Clin. Chem. 2012, 58:531-542.
20. Holmes E.W., Garbincius J., McKenna K.M. Analytical variability among methods for the measurement of 25-hydroxyvitamin D: still adding to the noise. Am. J. Clin. Pathol. 2013, 140:550-560.
21. Janssen M.J., Wielders J.P., Bekker C.C., Boesten L.S., Buijs M.M., Heijboer A.C., et al. Multicenter comparison study of current methods to measure 25-hydroxyvitamin D in serum. Steroids 2012, 77:1366-1372.
22. Siemens Advia Centaur® XP Vitamin D Total (Vit D) Assay [Directional Insert 10699314_EN Rev. C] 2012, Siemens Healthcare Diagnostics, Inc., Tarrytown, NY.
23. Roche® Modular Analytics E170 Vitamin D Assay [Directional Insert 06506780_EN V1] 2012, Roche Diagnostics, Inc., Indianapolis, IN.
24. ARCHITECT® 25-OH Vitamin D Assay [Directional Insert 3L52, G2-3231/R03] 2011, Abbott Laboratories, Abbott Park, IL.
25. Stockl D., Sluss P.M., Thienpont L.M. Specifications for trueness and precision of a reference measurement system for serum/plasma 25-hydroxyvitamin D analysis. Clin. Chim. Acta 2009, 408:8-13.
26. VDSP Vitamin D Standarization Program (VDSP) (Accessed November 13, 2014). http://www.ods.od.nih.gov/research/vdsp.aspx.
27. Viljoen A., Singh D.K., Farrington K., Twomey P.J. Analytical quality goals for 25-vitamin D based on biological variation. J. Clin. Lab. Anal. 2011, 25:130-133.
28. Singh R.J., Taylor R.L., Reddy G.S., Grebe S.K. C-3 epimers can account for a significant proportion of total circulating 25-hydroxyvitamin D in infants, complicating accurate measurement and interpretation of vitamin D status. J. Clin. Endocrinol. Metab. 2006, 91:3055-3061.
29. Lensmeyer G., Poquette M., Wiebe D., Binkley N. The C-3 epimer of 25-hydroxyvitamin D(3) is present in adult serum. J. Clin. Endocrinol. Metab. 2012, 97:163-168.
30. Unicel® DxI 25(OH) Vitamin D Total [Directional Insert A98856; DRAFT] 2013, Beckman Coulter, Inc., Brea, CA.
31. Access 25(OH) Vitamin D Total [Directional Insert B24838; DRAFT] 2013, Beckman Coulter, Inc., Brea, CA.
32. LIAISON® 25 OH Vitamin D Total Assay (310600) [Directional Insert us310600; 38242 7/12] 2012, DiaSorin Inc., Stillwater, MN.