Vitamin D status as an international issue: National surveys and the problem of standardization

Abstract Wide spread variation in measurement results of total 25-hydroxyvitamin D (25(OH)D) confounds international efforts to develop evidence-based clinical guidelines. Accordingly, NIH Office of Dietary Supplements (ODS) in collaboration with CDC National Center for Environmental Health (NCEH),...

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Vydáno v:Scandinavian journal of clinical & laboratory investigation. Supplement Ročník 72; číslo S243; s. 32 - 40
Hlavní autoři: Sempos, Christopher T., Vesper, Hubert W., Phinney, Karen W., Thienpont, Linda M., Coates, Paul M.
Médium: Journal Article
Jazyk:angličtina
Vydáno: Colchester Informa Healthcare 01.04.2012
Taylor & Francis
Informa
Témata:
25-hydroxyvitamin D
3-epi-25-hydroxyvitamin D
Biological and medical sciences
Calibration
CAP
CLSI
Commutability
DEQAS
Harmonization
Health Surveys
Humans
Investigative techniques, diagnostic techniques (general aspects)
Medical sciences
NIST
Reference Standards
Standardization
Traceability
Vitamin D - analogs & derivatives
Vitamin D - blood
CLSI
25-hydroxyvitamin D
Steroid hormone
Calcitriol
Standardization
Commutability
Calibration
Harmonization
Traceability
Survey
CAP
Vitamin D
3-epi-25-hydroxyvitamin D
Clinical biology
Cholecalciferol(25-hydroxy)
NIST
DEQAS
International
ISSN:0036-5513, 2166-1030, 1502-7686, 2166-1030
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Shrnutí:Abstract Wide spread variation in measurement results of total 25-hydroxyvitamin D (25(OH)D) confounds international efforts to develop evidence-based clinical guidelines. Accordingly, NIH Office of Dietary Supplements (ODS) in collaboration with CDC National Center for Environmental Health (NCEH), National Institute of Standards and Technology (NIST) and Ghent University established the Vitamin D Standardization Program (VDSP) in November 2010. VDSP objectives include: (1) standardize 25(OH)D concentration measurements in national health surveys around the world, (2) evaluate survey differences, (3) extend standardization efforts to assay manufacturers, and to clinical, commercial, and research laboratories, (4) promote standardization of emerging metabolites of vitamin D status, and (5) enable the use of standardized data in patient care and public health. An interlaboratory comparison study is being conducted to assess measurement variability among current assays. Participants include national health surveys from Australia, Canada, Germany, Ireland, Mexico, South Korea, UK and USA, 15 assay manufacturers, and two external quality assurance programs. CDC will implement a formal laboratory certification program. Standardization activities will use single-donor, fresh-frozen serum collected using the CLSI C37 protocol. Initial assay performance criteria, based on biological variability data, are ≤10 % imprecision and ≤5 % bias in relation to the reference values. An ancillary study on commutability of NIST SRM 972a, external quality assurance testing materials is included. To increase the comparability of existing data from different national surveys, master equations will be developed to facilitate the conversion of already existing national survey data to the NIST-Ghent University reference measurement procedures.
Bibliografie:ObjectType-Article-1
SourceType-Scholarly Journals-1
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content type line 23
ISSN:0036-5513
2166-1030
1502-7686
2166-1030
DOI:10.3109/00365513.2012.681935