The Future of Reference Materials - Science and Innovation presentation.pdfReference Materials for...
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Reference Materials for the Nutrition Community
The Future of Reference Materials - Science and Innovation
23 November 2010
Joseph M. Betz1, Mary Frances Picciano1, Karen Phinney2
1Office of Dietary Supplements, National Institutes of Health 2National Institute for Standards and Technology
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OFFICE OF DIETARY SUPPLEMENTS 2
NIH is the Nation’s Medical Research Agency
www.nih.gov
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OFFICE OF DIETARY SUPPLEMENTS 3
Reference Materials and ODS
ODS Analytical Methods and Reference Materials Program- multi-year project with NIST
• “Suites” of Standard Reference Materials – Supplement raw materials & finished products – Certified and Reference values for marker compounds,
nutrients, contaminants
• Calibration Standards www.nist.gov
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OFFICE OF DIETARY SUPPLEMENTS 4
Outcomes
Available• Botanicaloils(tocopherols)• Fishoil(FAs,tocopherols)• Ginkgo• Bi:erorange• Sawpalme:o• Mul?vitamin/mineraltablets• Botanical&fishoils(Ω3’s,6’s)• Greentea• Berries• Vit.Dinhumanserum
In Process • St.John’swort• Soy• Blackcohosh• Kudzu• Redclover• Turmeric• Pomegranate• Ginsengs(Asian,Siberian)
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OFFICE OF DIETARY SUPPLEMENTS 5
Foodswithvaluesassignedfornutrients(proximates,vitamins,carotenoids,elements,fa:yacids,aminoacidsasappropriate)
• SRM1849Infant/AdultNutri?onalFormula• SRM1946LakeSuperiorFishTissue• SRM2384BakingChocolate• SRM2385SlurriedSpinach• SRM2387PeanutBu:er• SRM3287Blueberry(Fruit)plus5moreinprogress
NIST SRM for Nutrition (available prior to ODS program)
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OFFICE OF DIETARY SUPPLEMENTS 6
• 909c‐Glucose,urea,uricacid,cholesterol,crea?nine,totalprotein,electrolytes
• 968e‐Fat‐SolubleVitamins,Carotenoids,Cholesterol,tocopherols,re?nol,beta‐carotene
• 2670‐ToxicElementsinUrine:14elements• 3950‐VitaminB6inHumanSerum
• 3951‐VitaminB12inHumanSerum
NIST SRM for Nutrition
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OFFICE OF DIETARY SUPPLEMENTS 7
CaseStudy:
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OFFICE OF DIETARY SUPPLEMENTS 8
Vitamin D Status of the US Population?
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OFFICE OF DIETARY SUPPLEMENTS 9
Lookeretal.AmJClinNutr2008;88:1519‐27.
• 1988-94 vs. 2000 - 2004: − Reformulation (introduction of antibody to
improve binding) of RIA assay kit shifts in assay results between these two time periods
− Adjusted for assay drifts to compare time trends in 25(OH)D and identify contributing factors
25(OH)D Assay Concerns (Looker et al., 2008)
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OFFICE OF DIETARY SUPPLEMENTS 10
• Adjustments for assay differences: − Looker et al. (2008):
• Overall mean 25(OH)D lower in 2000-2004 than in 1988-94 • Assay changes accounted for much of the difference
• No adjustment for assay differences: − Ginde et al. (2009):
• Marked decrease in 25(OH)D in 2000-2004 from 1988-1994 • Growing epidemic of vitamin D insufficiency
− Saintonge (2009): • Vitamin D deficiency is increasing from 1988-1994 to 2006 • National fortification and public health strategy
Adjustment Affects Policy Conclusions
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OFFICE OF DIETARY SUPPLEMENTS 11
• SRM972‐VitaminDmetabolitesinHumanSerum− Suiteoffour1.0mlvialswithcer?fiedandreference
valuesfor25(OH)D2,25(OH)D3,and3‐epi‐25(OH)D3
• SRM2972‐25(OH)D2&25(OH)D3Calibra?onSolu?ons− SRM2972isasetofethanoliccalibra?onsolu?onsand
hascer?fiedvaluesfor25(OH)D2and25(OH)D3
• Valueassignmentbyisotope‐dilu?onLC‐MSandLC‐MS/MS
• RMdrivesscience‐previouslythought3‐epionlyoccurredininfants
NIST SRM- July 2009
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OFFICE OF DIETARY SUPPLEMENTS 12
• Ques%onsaboutequivalenceofLC/MSassayresponseto25(OH)D2and25(OH)D3
− Immunoassaysmeasure“total”25(OH)D
− OlderLC/MSmethodsdidnotresolve3‐epimer
• 3‐epimersof25(OH)DmaybiasMS‐basedmethods
25(OH)D3 3‐epi‐25(OH)D3
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OFFICE OF DIETARY SUPPLEMENTS 13
NIST LC-MS Methodology for 25(OH)D
25(OH)D2‐[2H3]25(OH)D3‐[2H6]
25(OH)D3
3‐epi‐25(OH)D3
25(OH)D2
Taietal.(2010)AnalChem82:1942‐1948
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OFFICE OF DIETARY SUPPLEMENTS 14
Level165±15nmol/L25‐hydroxyvitaminD3(“normal”)
Level2Blendof“normal”serumandhorseserumtoobtainapproximatelyhalfthelevelof25‐hydroxyvitaminD3inthe“normal”pool(35±5nmol/L)
Level3“Normal”serumspikedwithequivalentamountof25‐hydroxyvitaminD2
Level4“Normal”serumspikedwith3‐epi‐25‐hydroxyvitaminD3
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OFFICE OF DIETARY SUPPLEMENTS 15
CommutabilityisdefinedastheequivalenceofthemathemaZcalrelaZonshipsbetweentheresultsofdifferentmeasurementproceduresforareferencematerialandforrepresentaZvesamplesfromhealthyanddiseasedindividuals.
Vesperetal.,Clin.Biochem.Rev.,28(2007)139
Reasonsareferencematerialmaynotbecommutable:
• Materialhandling,processing(lyophiliza?on,filtering,etc.)
• Supplementa?onwithna?veornon‐na?veanalytes
• Differencesbetweensamplesfromhealthyanddiseasedindividuals
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OFFICE OF DIETARY SUPPLEMENTS 16
OtherRMneeds
Marketedproducts‐matrices• Delayedreleasedosageforms‐ionexchangeresins,etc.
• Oil‐filledgelcaps‐vegetarianandanimalgela?n
• Microencapsulatedmaterials‐Carrageenan,gela?n,etc.
• “Nano”ingredientsinfinishedproducts• “Unusual”matrixsourcefornutrientsandnutrientelements‐e.g.iodineinkelpvsKI
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OFFICE OF DIETARY SUPPLEMENTS 17
OtherRMneeds
Clinicalmaterialsandcalibra?onstandards• Folate,othercomplexvitamersinserumforLC/MS
• Biomarkersofnutrientexposurevs.markersofNutrientstatus‐e.g.Omega‐3fa:yacidsinserumvs.redbloodcellmembrane
• Isotopelabelednutrientsandmetabolitesascalibra?onstandardsforMSdetec?on
• Serumbasedcalibra?onsolu?ons
Yetleyetal.(2010)JNutr140:2030S‐2045S
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OFFICE OF DIETARY SUPPLEMENTS 18
Non-RM Activities
NIST Vitamin D metabolite Laboratory Quality Assurance Program & Dietary Supplement Laboratory Quality Assurance Program
• NIST sends blinded material, practice sample – Participants perform analyses and return data to NIST – NIST provides feedback on blinded results, including
suggestions for method optimization
• To participate (no cost), send e-mail to [email protected]@nist.gov
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OFFICE OF DIETARY SUPPLEMENTS 19
“Reference Materials are the most efficient means to transfer accuracy to a field” -John Eckfeldt, MD, Ph.D. Professor of Laboratory Medicine, University
of Minnesota Medical Center
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OFFICE OF DIETARY SUPPLEMENTS 20
www.ods.od.nih.gov E-mail: [email protected]
E-mail: [email protected]
Joseph M. Betz
http://dietary-supplements.info.nih.gov/FactSheets/AMRMProgramWebsite.asp