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Reference Materials for the Nutrition Community The Future of Reference Materials - Science and Innovation 23 November 2010 Joseph M. Betz 1 , Mary Frances Picciano 1 , Karen Phinney 2 1 Office of Dietary Supplements, National Institutes of

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SLIDE 1

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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SLIDE 2

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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SLIDE 4

OFFICE OF DIETARY SUPPLEMENTS 4

Outcomes

Available 


  • Botanical
oils
(tocopherols)

  • Fish
oil
(FAs,
tocopherols)

  • Ginkgo

  • Bi:er
orange

  • Saw
palme:o

  • Mul?vitamin/mineral
tablets

  • Botanical
&
fish
oils
(Ω3’s,
6’s)

  • Green
tea

  • Berries

  • Vit.
D
in
human
serum


In Process

  • St.
John’s
wort

  • Soy

  • Black
cohosh

  • Kudzu

  • Red
clover

  • Turmeric

  • Pomegranate

  • Ginsengs
(Asian,
Siberian)

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SLIDE 5

OFFICE OF DIETARY SUPPLEMENTS 5

Foods
with
values
assigned
for
nutrients
(proximates, 
 vitamins,
carotenoids,
elements,
fa:y
acids,
amino
 acids
as
appropriate)


  • SRM
1849
Infant/Adult
Nutri?onal
Formula

  • SRM
1946
Lake
Superior
Fish
Tissue

  • SRM
2384
Baking
Chocolate

  • SRM
2385
Slurried
Spinach

  • SRM
2387
Peanut
Bu:er

  • SRM
3287
Blueberry
(Fruit)
plus
5
more
in
progress


NIST SRM for Nutrition (available prior to ODS program)

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SLIDE 6

OFFICE OF DIETARY SUPPLEMENTS 6

  • 909c‐Glucose,
urea,
uric
acid,
cholesterol,
crea?nine,
total


 
protein,
electrolytes


  • 968e‐Fat‐Soluble
Vitamins,
Carotenoids,
Cholesterol,



tocopherols,
re?nol,
beta‐carotene


  • 2670‐Toxic
Elements
in
Urine:
14
elements

  • 3950‐Vitamin
B6
in
Human
Serum

  • 3951‐Vitamin
B12
in
Human
Serum


NIST SRM for Nutrition

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SLIDE 7

OFFICE OF DIETARY SUPPLEMENTS 7

Case
Study:


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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

Looker
et
al.

Am
J
Clin
Nutr
2008;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

  • SRM
972‐
Vitamin
D
metabolites
in
Human
Serum


− Suite
of
four
1.0
ml
vials
with
cer?fied
and
reference
 
values
for
25(OH)D2,
25(OH)D3,
and
3‐epi‐25(OH)D3


  • SRM
2972‐
25(OH)D2
&
25(OH)D3
Calibra?on
Solu?ons


− SRM
2972
is
a
set
of
ethanolic
calibra?on
solu?ons
and
 
has
cer?fied
values
for
25(OH)D2
and
25(OH)D3


  • Value
assignment
by
isotope‐dilu?on
LC‐MS
and
LC‐MS/MS

  • RM
drives
science‐
previously
thought
3‐epi
only
occurred



in
infants


NIST SRM- July 2009

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OFFICE OF DIETARY SUPPLEMENTS 12

  • Ques%ons
about
equivalence
of
LC/MS
assay
response
to


25(OH)D2
and
25(OH)D3



− Immunoassays
measure
“total”
25(OH)D
 − Older
LC/MS
methods
did
not
resolve
3‐epimer


  • 3‐epimers
of
25(OH)D
may
bias
MS‐based
methods


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


Tai
et
al.
(2010)

Anal
Chem
82:1942‐1948


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OFFICE OF DIETARY SUPPLEMENTS 14

Level
1
 65
±
15
nmol/L
25‐hydroxyvitamin
D3
(“normal”)
 Level
2
 Blend
of
“normal”
serum
and
horse
serum
to
obtain
 approximately
half
the
level
of
25‐hydroxyvitamin
D3
in
the
 “normal”
pool
(35
±
5
nmol/L)
 Level
3
 “Normal”
serum
spiked
with
equivalent
amount
of
25‐ hydroxyvitamin
D2
 Level
4
 “Normal”
serum
spiked
with
3‐epi‐25‐hydroxyvitamin
D3


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OFFICE OF DIETARY SUPPLEMENTS 15

Commutability
is
defined
as
the
equivalence
of
the
 mathemaZcal
relaZonships
between
the
results
of
different
 measurement
procedures
for
a
reference
material
and
for
 representaZve
samples
from
healthy
and
diseased
individuals.



Vesper
et
al.,
Clin.
Biochem.
Rev.,
28
(2007)
139


Reasons
a
reference
material
may
not
be
commutable:


  • Material
handling,
processing
(lyophiliza?on,
filtering,
etc.)

  • Supplementa?on
with
na?ve
or
non‐na?ve
analytes

  • Differences
between
samples
from
healthy
and
diseased


individuals


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OFFICE OF DIETARY SUPPLEMENTS 16

Other
RM
needs


Marketed
products‐matrices


  • Delayed
release
dosage
forms‐
ion
exchange


resins,
etc.


  • Oil‐filled
gelcaps‐
vegetarian
and
animal
gela?n

  • Microencapsulated
materials‐
Carrageenan,


gela?n,
etc.


  • “Nano”
ingredients
in
finished
products

  • “Unusual”
matrix
source
for
nutrients
and


nutrient
elements‐
e.g.
iodine
in
kelp
vs
KI


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SLIDE 17

OFFICE OF DIETARY SUPPLEMENTS 17

Other
RM
needs


Clinical
materials
and
calibra?on
standards


  • Folate,
other
complex
vitamers
in
serum
for
LC/MS

  • Biomarkers
of
nutrient
exposure
vs.
markers
of


Nutrient
status‐
e.g.
Omega‐3
fa:y
acids
in
serum
 vs.
red
blood
cell
membrane


  • Isotope
labeled
nutrients
and
metabolites
as



calibra?on
standards
for
MS
detec?on


  • Serum
based
calibra?on
solu?ons


Yetley
et
al.
(2010)
J
Nutr
140:2030S‐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

vitdqap@nist.gov

or
DSQAP@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

  • f Minnesota Medical Center
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OFFICE OF DIETARY SUPPLEMENTS 20

www.ods.od.nih.gov E-mail: ods@nih.gov E-mail: betzj@mail.nih.gov

Joseph M. Betz

http://dietary-supplements.info.nih.gov/FactSheets/AMRMProgramWebsite.asp