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Tolan NV. Vitamin D. In: Rifai N, editor. New England journal of medicine knowledge+ and American association for clinical chemistry learning lab adaptive learning program. 2017. Available at: https://prod.area9labs.com. Accessed July 12, 2017.
- Burtis C.A. Ashwood E.R. Bruns D.A. Tietz textbook of clinical chemistry and molecular diagnostics vol. 5th edition. Saunders Elsevier, St. Louis (MO)2012: 1765
McCudden C. Vitamin D. 2012. Available at: http://media.aacc.org/Shows/Pearls/McCuddenVitaminD3-5-12/player.html. Accessed July 12, 2017.
- Ross A.C. Taylor C.L. Yaktine A.L. Del Valle B.H. Dietary Reference Intakes for Calcium and Vitamin D Institute of Medicine (US) Committee to Review Dietary Reference Intakes for Vitamin D and Calcium. National Academies Press (US), Washington (DC)2011
- The D-lemma: to screen or not to screen for 25-hydroxyvitamin D concentrations.Clin Chem. 2010; 56: 729-731
- Hypovitaminosis D in medical inpatients.N Engl J Med. 1998; 338: 777-783
- D is for Dilemma. Why are so many people popping vitamin D?.The New York Times, 2017
- Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline.J Clin Endocrinol Metab. 2011; 96: 1911-1930
- Vitamin D: the more we know, the less we know.Clin Chem. 2015; 61: 462-465
- Trends in laboratory test volumes for Medicare Part B reimbursements, 2000-2010.Arch Pathol Lab Med. 2014; 138: 189-203
- The C-3 epimer of 25-hydroxyvitamin D(3) is present in adult serum.J Clin Endocrinol Metab. 2012; 97: 163-168
- 3-epi-25 hydroxyvitamin D concentrations are not correlated with age in a cohort of infants and adults.Clin Chim Acta. 2012; 413: 203-206
- Overestimation of 25-hydroxyvitamin D3 by increased ionisation efficiency of 3-epi-25-hydroxyvitamin D3 in LC-MS/MS methods not separating both metabolites as determined by an LC-MS/MS method for separate quantification of 25-hydroxyvitamin D3, 3-epi-25-hydroxyvitamin D3 and 25-hydroxyvitamin D2 in human serum.J Chromatogr B Analyt Technol Biomed Life Sci. 2014; 967: 195-202
- High-throughput measurement of 25-hydroxyvitamin D by LC-MS/MS with separation of the C3-epimer interference for pediatric populations.Clin Chim Acta. 2016; 454: 102-106
- 25-hydroxyvitamin D: a difficult analyte.Clin Chem. 2012; 58: 486-488
- Influence of vitamin D2 percentage on accuracy of 4 commercial total 25-hydroxyvitamin D assays.Clin Chem. 2013; 59: 1273-1275
- Evaluation of the cross-reactivity of 25-hydroxyvitamin D2 on seven commercial immunoassays on native samples.Clin Chem Lab Med. 2012; 50: 2031-2032
- Performance evaluation of two immunoassays for 25-hydroxyvitamin D.J Clin Biochem Nutr. 2016; 58: 186-192
National Institutes of Health, Office of Dietary Supplements. Vitamin D Initiative. Available at: https://ods.od.nih.gov/Research/vdsp.aspx. Accessed February, 2016.
- A candidate reference measurement procedure for quantifying serum concentrations of 25-hydroxyvitamin D(3) and 25-hydroxyvitamin D(2) using isotope-dilution liquid chromatography-tandem mass spectrometry.Anal Bioanal Chem. 2015; 407: 5615-5624
- Price of High-Throughput 25-Hydroxyvitamin D Immunoassays: Frequency of Inaccurate Results.Journal of Applied Lab Med. 2017; 2: 461-463
- Clinical mass spectrometry-achieving prominence in laboratory medicine.Clin Chem. 2016; 62: 1-3
- An interview with David Millington.Clin Chem. 2016; 62: 12-19
- 25-hydroxyvitamin D-24-hydroxylase (CYP24A1): its important role in the degradation of vitamin D.Arch Biochem Biophys. 2012; 523: 9-18
FDA 510(k) Submission: waters masstrak immunosuppressants kit. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf6/K063868.pdf. Accessed December, 2017.
Titus K. Mass spec up front for pain management testing: Interest growing in oral fluid testing as alternative to urine testing. 2016. Available at: http://www.captodayonline.com/mass-spec-front-pain-management-testing-interest-growing-oral-fluid-testing-alternative-urine-testing/. Accessed June, 2016.
- Immunoassays for testosterone in women: better than a guess?.Clin Chem. 2003; 49: 1250-1251
FDA Overview of the process for clearance and approval of mass spectrometry-based in vitro diagnostic devices. Available at: https://www.msacl.org/documents/2018US/slides/MSACL2018US_FDA_Discussion_Group_slides.pdf. Accessed January 29, 2018.
- US Food and Drug Administration perspectives on clinical mass spectrometry.Clin Chem. 2016; 62: 41-47
U.S. Food and Drug Administration. Public workshop on mass spectrometry in the clinic: regulatory considerations surrounding validation of liquid chromatography-mass spectrometry Based Devices. 2016. Available at: https://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM496805.pdf. Accessed September, 2017.
- Protein-based multiplex assays: mock presubmissions to the US Food and Drug Administration.Clin Chem. 2010; 56: 165-171
- (CLSI document EP05-A3)Evaluation of precision of quantitative measurement procedures; approved guideline. 3rd edition. Clinical Laboratory Standards Institute (CLSI), Wayne (PA)2014
- (CLSI document EP06-A)Evaluation of the linearity of quantitative measurement procedures: a statistical approach; approved guideline. 1st edition. Clinical Laboratory Standards Institute (CLSI), Wayne (PA)2003
- (CLSI document EP17–A2)Evaluation of detection capability for clinical laboratory measurement procedures; approved guideline. 2nd edition. Clinical Laboratory Standards Institute (CLSI), Wayne (PA)2012
- (CLSI document EP07-A2)Interference testing in clinical chemistry; approved guideline. 2nd edition. Clinical Laboratory Standards Institute (CLSI), Wayne (PA)2005
- (CLSI document EP07–A2)Defining, establishing, and verifying reference intervals in the clinical laboratory; approved guideline. 3rd edition. Clinical Laboratory Standards Institute (CLSI), Wayne (PA)2010
- (CLSI document C62-A)Liquid chromatography-mass spectrometry methods; approved guidelines. Clinical Laboratory Standards Institute, Wayne (PA)2014
Disclosure Statement: Employment or leadership: SCIEX. Consultant or advisory role: None declared. Stock ownership: None declared. Honoraria: None declared. Research funding: SCIEX provided materials and reagents for the cited study. Expert testimony: None declared.
Role of Sponsor: The sponsor, SCIEX, (a) conducted final FDA studies and (b) reviewed and approved the final article.