Everything depends on having a partner you can trust

PUSHING THE LIMITS IN CLINICAL RESEARCH
Everything depends
on having a partner
you can trust
RELY ON AB SCIEX FOR PROVEN LC/MS/MS SOLUTIONS
The limitations of conventional techniques are accelerating the adoption of
mass spectrometry as a smart alternative for scores of clinical research
applications involving trace level quantitation of multiple compounds such as
endocrines, biomarkers, drugs of abuse and many more.
If you’re ready to break through, look no further than the industry leader.
With 25-years of experience delivering high-performance systems, software, and
support, AB SCIEX is a partner you can trust to integrate easy-to-use mass spec
technology into your lab’s day-to-day research routine. Save time, cut costs,
and solve analytical issues with greater confidence and better results.
Isn’t it time to break through the limits?
For more information, visit www.absciex.com/clinical-jcc
© 2012 AB SCIEX. For Research Use Only. Not for use in diagnostic procedures. The trademarks mentioned herein are the property of AB SCIEX Pte. Ltd. or their respective owners.
AACC Booth #4824
internal standards for
LC-MS/MS?
ask the experts
For a complete list of our Certified
Spiking Solutions® for Clinical
LC-MS/MS Applications, visit
Cerilliant.com
U
Analgesics
Label incorporation as well as isotopic purity and distribution can
U
Antidepressants
impact results. At Cerilliant we synthesize over 90% of the stable
U
Antiepileptics
labeled compounds used in our Snap-N-Spike® Certified Reference
U
Antipsychotics
Materials giving us control over synthetic design and quality
U
Caffeine-related Drugs
U
Cardiac Drugs
U
Catecholamines
U
Hormones
specifications. Our design is dictated by the intended end use of
each product including the incorporation of label position based on
mass spectral fragmentation.
—
—
—
—
—
Featured Products for Clinical LC-MS/MS Applications:
Female
Male
Neonatal
OH Vitamin D
Thyroid
Ê U
Testosterone-2,3,4-13C3
Ê U
Everolimus-D4
U
Immunosuppressants
Ê U
D6 -25-Hydroxyvitamin D3
U
Ê U
5-Hydroxyindole-4,6,7-D3 -3-acetic-D2 Acid
Nicotine / Tobacco
Metabolites
U
NSAIDs
Ê U
L-Thyroxine-13C6 (T4-13C6)
U
Ê U
Cortisol-D4
Vitamins (including
A, B, D, & E)
Visit Cerilliant.com or call:
800/848-7837
USA or CANADA
— Brian Schulmeier, MS
SYNTHESIS OPER ATIONS
512/238-9974
INTERNATIONAL
Also available through select
Sigma-Aldrich locations.
Visit www.sigma-aldrich.com/
cerilliant for more information.
Cerilliant Quality
ISO GUIDE 34
ISO/IEC 17025
ISO 13485
ISO 9001
GMP/GLP
© 2013 Cerilliant Corporation
CCJ 7/13
Download the free
Clinical Chemistry
App today!
Clin
Chem
The Clinical Chemistry
Trainee Council
It’s even easier to be a part of it!
Sign up for free with our new one-step
registration at traineecouncil.org
Now available in español at
traineecouncil.org/spanish
Even more content –
t
t
t
t
t
Pearls of Laboratory Medicine
CouncilChat
Podcasts
Webcasts
Q&As
Familial Hypercholesterolemia (FH) Array
A rapid, genetic assessment of patients with suspected FH
The FH Array from Randox offers rapid simultaneous detection of 20 mutations within the LDLR, ApoB and
PCSK9 genes.
s
s
s
s
s
s
Rapid, simple method for determining mutational status
Innovative multiplexing Biochip Array Technology reduces time and costs
Samples can be assessed in small batches
Easy to interpret results using the Evidence Investigator semi-automated analyzer
Protocol and reagents optimized for the molecular laboratory
Only a small sample of genomic DNA required
Visit us at
AACC Clinical
Lab Expo,
Booth #3245
Providing accurate diagnosis, enabling tailored treatment and improved patient outcomes
Randox Laboratories-US Limited, 515 Industrial Boulevard, Kearneysville, West Virginia, 25430
T +1 304 728 2890 TOLL FREE 866 4 RANDOX F +1 304 728 1890 TOLL FREE 866 RANDOX 1
I www.randox.com E [email protected].com
MOLECULAR DIAGNOSTICS
2014 Special Issue
call for papers
Clinical
Chemistry
Advancing Women’s Health: The
Impact of Biomarkers and Genomics
Submit Now
Clinical Chemistry is pleased to announce a special upcoming theme issue on Women’s Health edited
by Drs. Ann M. Gronowski, JoAnn E. Manson, Elaine R. Mardis, Samia Mora, and Catherine Y. Spong titled
“Advancing Women’s Health: The Impact of Biomarkers and Genomics.” Clinical Chemistry, published by the
American Association for Clinical Chemistry, is the most highly cited forum for peer-reviewed, original research
in the fields of clinical chemistry and laboratory medicine.
The purpose of this issue is to highlight recent advances in biochemical and genetic markers used for the
diagnosis, therapy, and preventive care of women during all stages of life. This issue will include diverse themes
such as cancer, cardiovascular disease, osteoporosis, metabolic disease, normal and abnormal pregnancy, infertility,
and infectious disease.
Clinical Chemistry invites authors to submit original articles related to women’s health to be considered for
publication in this special issue.
Potential topics of interest include:
s Discovery and validation of novel biomarkers for the diagnosis, prognosis, and monitoring therapy of
s
s
s
s
s
s
s
s
diseases that affect women including: cancer, cardiometabolic and/or cerebrovascular disease, bone
disease, and autoimmune disorders
The genomics of ovarian, uterine, cervical, and breast cancer
The effect of gender on the risk factors and outcomes related to diabetes, obesity, and cardiovascular
disease
Changes in the microbiome and biomarkers related to pregnancy
Novel molecular diagnostic tools for pre-implantation genetic analysis
Non-invasive screening for fetal aneuploidies and other pregnancy outcomes
Novel biomarkers for the diagnosis of pregnancy-related disorders such as pre-eclampsia, ectopic pregnancy,
preterm delivery, and gestational diabetes
Biomarkers for the diagnosis of infertility, menopause, and premature ovarian failure
The impact of infectious disease on the global health of women
Be a part of this exciting issue. Submit now!
Submissions must be received through our online submission system at http://submit.clinchem.org.
We welcome submissions after July 1, 2013, but cannot guarantee the inclusion of late submissions for the Special
Issue. Your cover letter should express your interest in submitting your paper for consideration for the Women’s
Health theme issue. Journal guidelines for submission apply as described in the Information for Authors on the
submission website.
With Simoa, researchers count
individual protein molecules, achieving
1000 fold improvements in sensitivity
over current immunoassays. Join
the digital revolution and discover the
extraordinary insights Simoa can deliver.
www.quanterix.com/simoa
2013 A A C C A N N U A L M E E T I NG P L E NA R Y S E S S I O N S
July 28–August 1, 2013
George R. Brown Convention Center
Houston, Texas
46/%":+6-:tQNoQN
DECONVOLUTING THE METABOLIC SYNDROME AT A MOLECULAR LEVEL
C. Ronald Kahn, MD
Type 2 diabetes (T2D) and metabolic syndrome are each the result of a
complex interaction between genes and environment. Studies in humans
have identified multiple genetic loci which contribute to these disorders,
but most have very small impact on disease expression. Mouse models
provide a powerful tool to investigate gene-environment interactions in
disease susceptibility. For example, among inbred mice, the C57BL/6J
mouse is susceptible to diet-induced T2D and metabolic syndrome,
whereas the 129 mouse is resistant to these phenotypes, despite the
fact that it eats more and moves less than the B6 mouse. Using these
and other mouse models, we have now identified genes which contribute to disease susceptibility. We have also explored the role of
environmental factors, including the gut microbiome. These studies
allow us for the first time to unravel how diet, genetic background, as
well as environment, contribute to creating common metabolic diseases
like obesity and T2D.
Come Prepared: Bezy O, Tran TT, Pihlajamäki J, Suzuki R, Emanuelli B,
Winnay J, et al. PKCð regulates hepatic insulin sensitivity and hepatosteatosis in mice and humans. J Clin Invest 2011;121:2504-17.
.0/%":+6-:tBNoBN
CHALLENGING THE DOGMA: A NEW VIEW OF THE GENOMIC PROGRAMMING OF HUMAN DEVELOPMENT John Mattick, PhD
Noncoding DNA accounts for 98.8% of the human genome. Many of these sequences are being shown to have important functions in differentiation
and development, as well as in cancer and other complex diseases. This session will examine the role of this noncoding or junk DNA in human
development.
56&4%":+6-:tBNoBN
THE VITAMIN D DEBATE: IS ENTHUSIASM OUTPACING THE EVIDENCE?
Vitamin D has been implicated in the prevention of cancer, cardiovascular disease (CVD), diabetes, infections, depression, asthma, autoimmune
diseases, and many other disorders. The available research derives primarily from laboratory research and observational epidemiologic studies,
but large-scale randomized trials of vitamin D are very limited. Small randomized trials to date have provided mixed and inconclusive results. Although many experts are now recommending vitamin D intakes at levels far above the IOM’s dietary recommended allowance (RDA), this remains
controversial. Two experts involved with vitamin D research will debate the evidence for and against public health recommendations for vitamin D
intakes above the RDA for the general population.
Advocating for Increased Intake – Bruce W. Hollis, PhD
Bruce W. Hollis, PhD, Professor and Director of Pediatric Nutritional Sciences at Medical University of South Carolina, will review and present
evidence for higher vitamin D intakes required to sustain adequate nutritional vitamin D status for all aspects of human development including
pregnancy and lactation. Human lactation and nourishment of the human neonate provides the most clear-cut evidence of why recent IOM
recommendations fall far short of what is actually required for adequate vitamin D intakes.
Come Prepared: Hollis BW and Wagner CL. Vitamin D and pregnancy: skeletal dffects, nonskeletal effects, and birth outcomes. Calcif Tissue
Intl 2013; 92:128-39.
S UND A Y, JUL Y 2 8 – T H U R S DA Y , A U G U S T 1 , 2 013
Opposing Increased Intake – JoAnn E. Manson, MD, DrPH
JoAnn E. Manson, MD, DrPH, endocrinologist, Professor at Harvard Medical School, and Principal Investigator of the large-scale VITamin D and
OmegA-3 TriaL (VITAL), will review the scientific evidence for the role of vitamin D in the prevention of cancer, CVD, and other chronic diseases.
She will address design issues relevant to current research, including the potential for confounding in observational studies, and will emphasize
the critical need for large-scale randomized trials before recommending high-dose vitamin D supplementation (well above the RDA) for the
general population.
Come Prepared: Ross AC, Manson JE, Abrams SA, Aloia JF, Brannon PM, Clinton SK, et al. The 2011 report on dietary reference intakes for
calcium and vitamin D from the Institute of Medicine: what clinicians need to know. J Clin Endocrinol Metab 2011; 96:53–8.
8&%/&4%":+6-:tBNoBN
PATIENT-BASED THERAPEUTICS DISCOVERY
Stuart L. Schreiber, PhD
Human biology, insights gained from patients, and small-molecule science offer a powerful way to propel the understanding and treatment of
human diseases. The ability to measure heritable and somatic genetic variation in humans with and without disease offers a particularly promising
avenue towards new small-molecule therapeutics. For this approach to be
successful, we will need to relate human genetic variation to small-molecule
sensitivity and drug efficacy as comprehensively as possible.
Therapeutic targets that emerge from human biology and patients have
been validated to some degree prior to clinical testing by genetic “experiments of nature.” But the therapeutic targets that emerge are often
unfamiliar to traditional small-molecule drug discovery efforts. Thus,
advances in chemistry and chemical biology are also required to test
hypotheses emerging from human biology in humans with small molecules.
Come Prepared: The Cancer Target Discovery and Development Network,
Schreiber SL, Shamji AF, Clemons PA, Hon C, Koehler AN, et al. Towards
patient-based cancer therapeutics. Nature Biotech 2010; 28:904-906.
5)634%":"6(645tQNoQN
DINING IN WITH TRILLIONS OF FASCINATING FRIENDS
Jeffrey Gordon, MD
Our genetic landscape is a summation of the genes embedded in our human genome and in the genomes of our microbial symbionts (the microbiome). Similarly, our metabolic features (metabotypes) are an amalgamation of human and microbial contributions. Therefore, understanding
of the range of human genetic and metabolic diversity means that we must characterize
our microbiomes, which contain >100-fold more genes than our human genome, as
well as the factors that influence the properties of our microbial communities. The
results should provide an additional perspective about contemporary human biology
as we seek to understand how our changing lifestyles, cultural norms, socioeconomic
status, and biosphere are influencing our microbial ecology and health status. I will
discuss the results of our group’s ongoing studies of the interrelationships between
diet and the structure and dynamic operations of the human gut microbiome. We
believe that understanding these interrelationships is important for advancing our
appreciation of the nutritional value and health effects of food ingredients, for creating
new nutritional guidelines for humans at various stages of their lifespan, and for
developing new ways to deliberately manipulate the properties of the gut microbiome
to prevent or treat various diseases, including those manifested by immune dysfunction.
Come Prepared: Smith MI, Yatsunenko T, Manary MJ, Trehan I, Mkakosya R, Cheng J, et al. Gut microbiomes of Malawian twin pairs
discordant for kwashiorkor. Science 2013;339:548-54.
Gordon, JI. Honor thy gut symbionts redux. Science 2012; 336:1251-3.
2013
WEBINARS
The AACC/Seattle
e Children’s Hosp
pital
Don’t miss this series of eight webinars designed just for you.
Tools and skills to perform your duties more effectively
Proven techniques to manage complex human resource issues
AVAI
A LLA
ABL
BLE
E NO
OW
Hap
appy
y Lab
b, Happy
Ha y Li
Liffe:: Ad
A drresssi
sin
ng Com
ng
mmonlly N
Ne
egl
gle
ected
ecte
d Hu
Huma
man Reso
source
Con
onsi
sid
si
idera
derati
tion
ti
o s in the
on
e Lab
ab
MARCH 14
1
Connecting Laboratory Staff to the Patien
nt Experience:
A Recip
ip
pe for Labo
orato
tory Succe
cesss
ce
ss
APRILL 16
AP
Tweetin
i g vs
vs.. Kn
nit
i ting
ng: Over
erco
comi
ming
i Gener
erat
atio
ional Co
Confl
flictts in the Cli
linical Lab
MAY 9
MA
U in
Us
ng Me
Metr
triccs in the
he Q
Qua
u liity LLab
abor
orat
a ory: The
at
h Good, the Bad and the Ugly
AU
AUGU
UGUST
GUST 2
22
2
Cre
reat
atin
at
i g,
in
g Com
mmu
uni
nica
cati
ca
ting
ti
ng,, an
a d Ma
M in
nta
tain
inin
ing Ef
Efffect
ctiv
ct
ive
iv
ve La
Lab
bora
bo
rato
tory
ry SOP
SOPs
OPs
SEPTEMBER 24
Designing and Using the Laboratory Quality Dashboard
OCTOBER 15
Modern Approachess to Quality Contro
ol: M
Mov
ovin
ing
g Averages
es and Bey
Beyond
NOVEMBER 21
Achieving
h
Concordance
d
Bettween POCT Resullts and Central Lab
b Results
Moderated by:
Michael Astion, MD, PhD
Division Chief, Laboratory Medicine, Seattle Children’s Hospital, and
Clinical Professor, University of Washington Department of Laboratory Medicine
Webinars take place from 2:00 – 3:00 pm Eastern U.S. Time (11:00 am – 12:00 pm Pacific U.S. Time)
Each program is 60 minutes long. Registration per program is $195.
To register, visit aacc.org, click on the Events tab and choose “Webinars.”
Or call AACC Customer Service at 800.892.1400 or 202.857.0717.
Presented by
and
CONFERENCE
St. Louis, Mo.
Mass spectrometry is fast becoming the analytical method of
choice for many clinical assays. This program will tackle and attempt
to demystify some of the issues that have arisen as this technology evolves
into a routine laboratory tool.
Leading clinical experts in mass spectrometry will show you:
•
•
•
•
•
Whether mass spectrometry is right for your application
How to overcome challenges in sample prep
New guidelines for mass spectrometry method development and validation
Ways to manage and maintain data
Post-analytical QA/QC of your mass spec methods
In addition, we’ll examine some of the applications already being used in the clinical
lab, including:
•
•
•
•
TDM and immunosuppressants
Pain management
Toxicology screening and confirmation
Androgen and vitamin D analyses
Join our expert faculty as they highlight the areas where early adopters are using
mass spectrometry-based test platforms; medical and business issues to consider when
introducing mass spectrometry assays or expanding the mass spectrometry test menu;
validation and QC concerns; and options in data management.
Register today at www.aacc.org/events
........
Health literacy, now
in the palm of your hand.
Connect to Lab Tests Online Mobile.
Absolutely
love
“Thank you for this valuable
tool.
Your app gave me the right
your site.
information at the right time.”
www.labtestonline.org
Our Sponsors
Beckman Coulter
Ortho Clinical Diagnostics
Roche Diagnostics
Siemens Healthcare Diagnostics
Abbott Diagnostics
Spectra Laboratories
Fujirebio Diagnostics
Hycor Biomedical
Our Partners
ITC Nexus Dx
AACC
PAML
ASCLS
Sebia, Inc.
ASM
Professional Co-op
CLMA
CompuGroup Medical
ASH
Randox
AMP
Sysmex
ASCP
CAP
CSMLS
CSCC
CLSI
NACB
Joint Commission
APHL
AABB
AAB
AAFP-PT
.....
.....
.....
Find us online and on our mobile app:
Follow us on Facebook and Twitter.
Contact [email protected] to become a sponsor.
Advertising Representatives
Scherago International, Inc.
Authors may order reprints
of their articles by
contacting
Ginger Larrimore
1-866-487-5625 or
410-943-3728
For commercial reprints,
to increase your
marketing visibility, contact
Cadmus Reprints,
Toll free
1-866-487-5625 ext. 3736 or
410-943-3736 or email:
[email protected]
Director: HERBERT L. BURKLUND
Traffıc Manager: OLGA GUERRA
Advertising Sales Manager: MIKE MINAKOWSKI
Marketing Manager: STEVEN HAMBURGER
ADVERTISING CORRESPONDENCE: 525 Washington Blvd.
Suite 3310
Jersey City, NJ 07310
Tel (201) 653-4777
Fax (201) 653-5705
ADVERTISER
AB SCIEX
Cerilliant Corporation
Immundiagnostik
Quanterix Corporation
Randox LaboratoriesLtd.
PAGE NO.
Cover 2
Cover 7A
C4
11A
9A
ALL THE ELEMENTS
OF LABORATORY
MANAGEMENT, RESEARCH
AND CUTTING-EDGE
TECHNOLOGY WILL
BE THERE. WILL YOU?
THE WORLD’S LARGEST GATHERING
FOR LABORATORY MEDICINE
+
ANNUAL MEETING
& CLINICAL LAB EXPO 2013
200+ New Product Introductions. This is THE place to learn
about cutting edge technology in laboratory medicine.
+
+
17,000+ Attendees. Join the global leaders in clinical chemistry,
JULY 28-AUGUST 1, 2013
molecular diagnostics, mass spectrometry, translational medicine,
GEORGE R. BROWN
lab management, lab medicine and more.
CONVENTION CENTER
5 Packed Days. Build your agenda with educational sessions,
HOUSTON, TEXAS USA
networking, new science and technology previews, and more.
The New York Times recently
ranked Houston as one of the
top places to see in 2013.
REGISTRATION NOW OPEN
www.aacc.org/2013am
IBD diagnostics & therapy control
Calprotectin & TNFD blocker
monitoring
PhiCal® Calprotectin ELISA
ÂFecal calprotectin: Established marker
of intestinal inflammation
ÂFor the differentiation of IBD and IBS
ÂFor therapy monitoring of IBD patients
No
able i
w a va i l
n the U
SA!
ÂFast: 1h
ÂSpecific: Monoclonal antibodies
ÂPrecise: Cut-off at 50 µg/g
ÂSignificant: Linearity up to 2100 µg/g
ÂPractical: Validated protocols for automated systems
TNFD Blocker ELISA Panel
Â
Determination of drug levels and anti-drug antibodies (ADA) in serum/plasma
Â
For individual management of TNFDblocker therapy in IBD patients
ÂFor the detection of immunogenicity of TNFDblockers Infliximab,
Adalimumab, Etanercept
Immundiagnostik AG · Stubenwald-Allee 8a · 64625 Bensheim · Germany · Phone: +49 (0) 62 51/70 19 00
Fax: +49 (0) 62 51/84 94 30 · [email protected] · www.Immundiagnostik.com