neotox | fall 2015

PEth

NeoTox

4Investigating the potential of PEth testing in newborn dried blood spot specimens.

8What ISO 17025 certification means for USDTL clients.

10National positivity rates in umbilical cord and meconium specimens.

Clarity in Newborn Toxicology | v.6 i.3

Revealing the Future TodayUSDTL embarks on new

research in the detection of

prenatal alcohol exposure.

Fall

2015

2 Fall 2015 NeoTox

Letter from the editor

HOPE IN THE FUTURE

Despite a landscape of increasing newborn drug and alcohol exposure, we have faith in the future and the potential to create positive change for positive outcomes. Solid research efforts and the will to make a difference will get us there.

Sometimes the outlook is just too bleak. It can be hard to see hope. The numbers can be discouraging. More than 5% of pregnant women in the U.S. are current illicit drug users at any given time. As many as 8.5% of pregnant women consume alcohol during pregnancy, and 2.7% consume alcohol heavily. Almost 16% - 1 in 6 - women smoke during pregnancy. Research conducted over the past decade has led many healthcare professionals to believe these numbers are underestimates, due to the stigma associated with self-reporting any kind of substance use during pregnancy.

Research has never found a safe level of drugs, cigarettes, or alcohol for a woman to consume during pregnancy, so any level of newborn substance exposure is discouraging. For us, this is what drives our vision as a toxicology lab - leveraging our newborn toxicology knowledge to “Enrich and Protect Lives.” In service to that vision, we have held ourselves to the highest possible standard since day one.

To that end, we have sought and achieved the most stringent laboratory accreditation standard in the world, ISO/IEC 17025 laboratory accreditation. This achievement confirms our commitment to our clients, and to the newborn lives they serve and protect.

We are also pushing the limits of our knowledge to break through the barriers of the impossible and find the solutions that lie on the other side. Our recent undertaking of an international research collaboration with investigators at Northwestern University (Evanston, IL) and Hospital Pereira Rossell in Montevideo, Uruguay, will expand the edges of what is possible in the service of alcohol exposed newborns.

It would be wonderful to think that some day our expertise and services will no longer be needed. But for now they are. For now, we can see hope for the future, because that is the premise that USDTL was founded on. No matter how grim the outlook, the future holds promise as long as we try a little harder and push the boundaries, every moment of every day.

Thanks for reading,Michelle Lach, Editor-in-Chief

3USDTL

Table of Contents

4

BREAKING THE BLOOD BARRIERJoseph Salerno, MS

A new research collaboration between Northwestern University Feinberg School of Medicine, Hospital Pereira Rossell, Montevideo, Uruguay, and USDTL will investigate the potential for routine newborn screening for prenatal alcohol exposure measuring PEth in dried blood spots.

8

A HABIT OF EXCELLENCEJoseph Salerno, MS

Following on 25 years of industry leading innovation, experience, and professionalism, USDTL reaffirms the commitment to quality by achieving accreditation for the international ISO/IEC 17025 laboratory standard.

10

NATIONAL POSITIVITY RATES

USDTL quarterly national results for drug and alcohol testing in umbilical cord and meconium specimens.

Cover illustration by Joseph Salerno.

NeoToxFall 2015volume 6

issue 3

Editor-in-Chief Michelle Lach, MSIMC

Managing & Design EditorJoseph Salerno, MS

Graphic DesignerDru Wagner, MA

Science Advisory BoardDouglas Lewis, D.Sc.

Joseph Jones, MS NRCC-TCAdam Negrusz, Ph.D. F-ABFT

NeoTox is a quarterly news magazine of science, data, and news about perinatal toxicology and substance exposure issues. It is our mission to distill the technical world of toxicology, drug testing, and addiction science into plain words. If you have suggestions for topics you would like to know more about, let us know.

[email protected]

1700 S. Mount Prospect Rd.Des Plaines, IL, 60018

847.235.2367

© 2015 USDTL, Inc. All Rights Reserved.

USDTL.com

http://USDTL.com

4 Fall 2015 NeoTox

BREAKING THE BLOOD

BARRIERA new research collaboration between Northwestern University Feinberg School of Medicine, Hospital Pereira Rossell, Montevideo, Uruguay, and USDTL will investigate the potential for routine newborn screening for prenatal alcohol exposure measuring PEth in dried blood spots.

by Joseph Salerno, MS

United States Drug Testing Laboratories, Inc. was created from the need to more effectively address the issue of neonatal exposure to drugs and alcohol. In our 25 years since that inception we have spearheaded the wave of innovation in neonatal toxicology testing. Continuing a 25 year conviction to protect and enrich newborn lives, researchers at USDTL have embarked on a new research collaboration to investigate routine screening of newborns for prenatal alcohol exposure by measuring the direct alcohol biomarker phosphatidylethanol (PEth) in dried blood spots from both umbilical cord blood and newborn heel sticks. The four year international research grant from the National Institute on Alcohol Abuse and Alcoholism (NIAAA) will provide large-scale data to support routine screening. Research Scientist Dr. Aileen Baldwin, Ph.D., M.P.H., will spearhead USDTL’s efforts in collaboration with

prominent neonatal researchers from Northwestern University’s Feinberg School of Medicine (Chicago, IL) and Hospital Pereira Rossell, Montevideo, Uruguay.

Prenatal alcohol exposure is the leading preventable cause of birth defects in the United

States. Alcohol use during pregnancy can result in a range of adverse outcomes known as fetal alcohol spectrum disorders (FASD). The most severe cases of FASD, known as fetal alcohol syndrome (FAS) can lead to severe negative impacts on the child, including growth deficiency, central nervous system dysfunction, and changes from normal physiology and behavior. [1] It is estimated that 8% of U.S. women drink during their pregnancy, leading to an estimated incidence of FASD of 2-5% of all newborns. [2]

The effects of FASD/FAS can manifest as ongoing developmental issues and can affect a child throughout their lifetime. Early diagnosis of FASD is key to effective interventions and treatments. Children under the age of three may benefit from early neuroplasticity, and early identification of FASD/FAS may reduce long-term adverse effects and help affected children achieve parity with their

peers. [3]PEth has been shown to be

a highly sensitive and specific direct alcohol biomarker for adult alcohol testing. [4] This

research aims to examine the potential for PEth to be a highly sensitive and specific indicator of prenatal alcohol exposure. If successful, the analysis of PEth in dried blood spot cards would be a powerful, universally available testing sample and

Continued on page 9, Research.

This research aims to examine the potential for PEth to be a highly sensitive and specific indicator of prenatal alcohol exposure.

5USDTL

Formation of phosphatidylethanol (PEth)

red blood ce

ll mem

brane

= ethanol

= PEth

PEth is an abnormal phospholipid that is created by red blood cells as they encounter alcohol in the blood.

PEth is stored in the cell membrane and can be extracted from dried blood spot specimens and measured to identify alcohol exposure.

Advantages of PEth*

100% specific for ethanol. PEth can only beformed in the presence of ethanol.

Identifies heavy episodic drinking (5 or more drinksin one sitting) for up to the last 30 days prior to measurement.

PEth levels are not affected by race, gender, BMI, or disease state.

Dried blood spot specimens for PEth analysis are easy to collect and non-invasive.* These statements have only been established in adult PEth testing.

The research outlined here aims to establish these characteristics for newborn PEth testing as well.

ISO / IEC17025

ISO/IEC 17025 accreditation is the single most important competency standard applied to testing and calibration laboratories around the globe. Laboratories accredited to this standard have demonstrated significant technical ability to reliably generate and reproduce accurate, precise and consistent data.

Immediately after accepting his new leadership role in 2014, USDTL Laboratory Director, Dr. Adam Negrusz, began the endeavor to achieve ISO/IEC 17025 accreditation. Working closely with QC/QA Manager, Michelle Pilkington, Dr. Negrusz set out to successfully finish the process within two years. All their efforts, combined with a company-wide determination, allowed us to achieve accreditation within 14 months time - 10 months less than our original goal. That accomplishment is

a testament to USDTL’s historical adherence to the highest possible laboratory and business standards.

We are proud to announce that we are the first laboratory in the world to be ISO/IEC 17025 accredited for drug and alcohol testing in umbilical cord, fingernail, and toenail specimens. On September 4, 2015, USDTL attained ISO/IEC 17025 accreditation showing full compliance with the competency standards of the International Organization for Standardization and the

International Electrotechnical Commission in the field of Forensic Testing.

It is important to point out that this standard and level of expertise is nothing new to us. Since our beginnings in 1991, we have always maintained the highest level of quality and competency, providing our clients with the most responsive and personal service in the drug and alcohol testing industry. ISO/IEC 17025 accreditation reaffirms that commitment to our clients, and officially codifies it for all aspects of our testing and client advocacy. Now, as before, our clients can always have absolute confidence that the results of every specimen tested by our laboratory will meet the international standards.

The scope of our accreditation encompasses all aspects of our laboratory system, well beyond

just our accredited general laboratory methodologies. Not one single function within the umbrella of our testing services is outside the scope of our accreditation. All

specimen types analyzed by USDTL are accredited, including umbilical cord, meconium, breast milk, all keratinized specimens (fingernails, toenails, hair), urine, oral fluid, and blood. USDTL is now the only lab in the United States to offer PEth (phosphatidylethanol) testing for alcohol use under the ISO/IEC 17025 standard.

As a global innovator in the science and

Continued on page 8, Accredited.

A HABIT OF EXCELLENCE

Following on 25 years of industry leading innovation, experience, and professionalism, USDTL reaffirms the commitment to quality by achieving accreditation for the international ISO/IEC 17025 laboratory standard.

by Joseph Salerno, MS

We are proud to announce that we are the first laboratory in the world to be ISO/IEC 17025 accredited for drug and alcohol testing in

umbilical cord, fingernail, and toenail specimens.

Fall 2015 NeoTox6

ISO / IEC17025 7USDTL

8 Fall 2015 NeoTox

Accredited, continued from page 6.

technology of substance abuse toxicology, we have maximized the capabilities of our instruments to achieve the lowest positive result cutoffs in the industry for many toxicology tests. Our carboxy-THC cutoff level for a positive cannabinoid test result is the lowest achieved by any reference lab in the U.S. Exhaustive research and maximization of our technology led us to develop the lowest umbilical testing cutoffs in the industry. Our use of technology to improve our clients’ data has always been a premier aspect of our work.

Now, in addition to being at the forefront of toxicology expertise, our methodologies and instrumentation are fully accredited to the ISO/IEC 17025 standard. Accreditation under this standard increases the evidential acceptance of our laboratory results in virtually all jurisdictions. As a forensic testing laboratory this is of the highest importance to us, because every testing result has

the possibility of becoming evidence in a court of law.

The 17025 standard was first codified by ISO and IEC in 1999, and was further amended and improved in 2005. Explicit requirements for continuing improvement of management systems, with an emphasis on the responsibilities of senior management, is central to the 2005 revisions. An efficient management system ensures fast resolution of laboratory issues regarding methods and equipment. Even before ISO/IEC 17025 accreditation, this was one of the cornerstones to USDTL’s results turn-around time - one of the fastest in the industry - and outstanding customer advocacy, and will remain so moving forward.

To view our certificate of accreditation, visit us online at www.usdtl.com/media/certifications/USDTL-ISO17025.pdf. If you have questions about ISO/IEC 17025 accreditation, please contact us at [email protected] or 800.235.2367.Page 7 illustration by Joseph Salerno.

DID YOU KNOW?USDTL holds several international, state, and federal certifications and accreditations.

College of American Pathologists

Accreditation

Oklahoma State Department of Health Certified Laboratory

Iowa Department of Health Approved Laboratory Lists

New York State Department of Health Clinical Laboratory Permit

Florida Agency for Health Care Administration Licensed Clinical Laboratory

Maryland Department of Health and Mental Hygiene Office of Health Care Quality Medical Laboratory Permit

Illinois Department of Financial and Professional Regulation Controlled Substances Licensee

9USDTL

Research, continued from page 4.

assay to identify prenatal alcohol exposure.The four year study, awarded to the Feinberg

School of Medicine, is an international collaboration involving USDTL, Dr. Michael Fleming, M.D., M.P.H., (Project Leader and Principle Investigator, Feinberg School of Medicine), and Dr. Raquel Magri, M.D. (Colegio Iberoamericano de Adicciones at Hospital Pereira Rossell, Montevideo, Uruguay), with expert Consultation from Dr. Phillip May, Ph.D. (University of North Carolina, Gillings School of Global Public Health, Kannapolis, NC). “We are very interested in discerning the detailed characteristics of maternal risk and protection for fetal alcohol spectrum disorders in this unique binge drinking population that will guide prevention and intervention in the future,” said Dr. May, “This research will help to ensure healthier babies in the future, not just in Montevideo and Uruguay, but in other countries with similar risk profiles and similar social and public health conditions. ”

This work will focus on a cross-sectional study of 1500 women, ages 18 years and older, and their newborns in the city of Montevideo, Uruguay. Previous work in public health care hospitals in Montevideo, Uruguay documented high rates of alcohol use during pregnancy (60%) as well as PEth levels in newborns (79%). [5] “The country has a high prevalence of alcohol consumption among young women, including those who are pregnant and in low and middle-low socioeconomic and educational status, whose babies might be more at risk for FASD,” said Dr. Magri, “The results will help to start the actions in a strategy to lessen this consumption.”

Alcohol use in the previous studies was documented through self-report surveys of pregnant women. The current undertaking will also examine PEth levels in mothers and investigate the correlation between maternal and neonatal PEth

measurements. PEth is a newer biomarker that detects episodic heavy drinking (5 or more drinks in one sitting) for up to the last 30 days. PEth testing is 100% specific in detecting recent alcohol use with no known false positives.

A strong correlation between maternal and neonatal PEth levels would offer the possibility of a universally available tool that will prevent undetected cases of prenatal alcohol exposure, increasing the potential for newborns to receive early developmental interventions when necessary and prevent them from slipping through the cracks. “A new biomarker for alcohol, more accurate and

easy to collect will probably present more positive results in a population with highest prevalence,” said Dr. Magri, “There is strong experience with this group of researchers, who have worked together in this area in three previous studies.” The future of neonatal alcohol screening is promising.References1. Barr, HM, Streissguth, AP. (2001). Identifying

maternal self-reported alcohol use associated with fetal

alcohol spectrum disorders. Alcoholism: Clinical and

Experimental Research, 25, 283-287.

2. May PA, Baete A, Russo J, Elliott AJ, Blankenship J,

Kalberg WO, Buckley D, Brooks M, Hasken J, Abdul-

Rahman O, Adam MP, Robinson LK, Manning M,

Hoyme HE. (2014). Prevalence and characteristics of

fetal alcohol spectrum disorders. Pediatrics, 134, 855-866.

3. Mitchell, KT. (2002). Fetal alcohol syndrome: Practical

suggestions and support for families and caregivers.

Washington, DC: National Organization on Fetal

Alcohol Syndrome.

4. Hartmann, S, Aradottir, S, Graf, M, Wiesbeck, G,

Lesch, O, Ramskogler, K, Wurst, FM. (2007). Addiction

Biology, 12(1), 81-84.

5. Unpublished data, NIAAA Small Business Innovation

Research Funding.

Page 5 illustration by Joseph Salerno.

A strong correlation between maternal and neonatal PEth levels would offer the possibility of a universally available tool that will prevent undetected cases of prenatal alcohol exposure...

http://onlinelibrary.wiley.com/doi/10.1111/j.1530-0277.2001.tb02210.x/abstract




http://www.ncbi.nlm.nih.gov/pubmed/25349310





http://onlinelibrary.wiley.com/doi/10.1111/j.1369-1600.2006.00040.x/abstract



EVENTS & EXHIBITS

• February 17-20 – The 29th Annual Gravens Conference on the Physical and Developmental Environment of the High Risk Infant, in collaboration with the March of Dimes – Clearwater Beach, FL

• February 25-28 – NEO: The Conference for Neonatology & Specialty Review in Neonatology – Orlando, FL

• April 30 - May 5 – 2016 Pediatric Academic Societies Annual Meeting – Baltimore, MD

1700 S. Mount Prospect Rd. | Des Plaines, IL 60018 | 800.235.2367 | www.USDTL.com

The Leader in Newborn Toxicology

®

12 Fall 2015 NeoTox

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