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OraSure Technologies, Inc.Oral Fluid Drug and
Alcohol Testing
04Oral fluid Alcohol Test .
Q.E.D.®01Midwest Builders CasualtyOraSure
Introductions
03
What is Oral Fluid and Intercept?
02
02
What are the most common trends today in drug abuse?
Trends in Drug Testing
AgendaMarch 15, 2018
2
How accurateis oral fluid
drug testing for THC?
What regulations
should I follow?
Should I still test for Marijuana?
How can I switch to oral fluid testing?
How does oral fluid compare with other test types?
What do I do about testing for
prescription drugs?
How can I switch to oral fluid testing?
What is my ROI?
What’s on Everyone’s Mind
3
What is Oral Fluid?
Oral fluid / saliva• Combination of 3 glandular fluids, some
minor glands.
• “Blood/Serum-like” fluid we call oral fluid.
• Drugs cross over from the blood stream
into oral fluid allowing us to test for them.
4
Oral Fluid vs. Urine Drug Testing
Drug Test Urine Analysis (%)
Oral Fluid Analysis (%)
Marijuana 2.4 7.5
Cocaine 0.25 0.46
Amphetamine 1.11 0.56
Opiates 0.49 0.78
PCP 0.02 0.04
Methamphetamine n/a 0.29
5
Positivity rates – general workforce samples (non-regulated)*
Overall Positivity
Accuracy and performance like this has convinced HHS to add laboratory based oral fluid testing to the SAMHSA Federal guidelines.
Windows of Detection for Various Matrices
6
Did You Know?Oral fluid detection starts about 15 minutes after drug use and continues for 2-3 days depending on various factors.
Eliminates Collection Hassles, Reduce Costs
01 Expedite specimen collection
Eliminate collector gender issues
Eliminate shy bladder
Collect anytime/anywhere
Collect in any environment
Eliminates DrugTest Cheating
02
Observe collection
Non-invasive collection
Eliminate substitution
Eliminate dilution
Eliminate additives
7
Benefits of Oral Fluid Drug TestingLab-based solutions
Maintains SuperiorLaboratory Confidence
03
Capture “Under the influence”
Capture accurate positive rates
Test for current drug trends
SAMHSA approved laboratories
GC/MS and/or LC/MS confirmatory testing
Safeguards LegalDefensibility
04
Certified MRO confirmation
Established chain-of-custody
Comprehensive donor inclusion
Scientifically proven technology
Hundreds of “peer-reviewed”journal articles
Urine Adulteration & Tampering – Easy and Effective
8
Did You Know?A Google inquiry on “How to pass a drug test in 24 hours” yields more than 5,030,000 results.
All are ineffective using oral fluid
It’s big business–Ways to beat a urine test
• Dilution (most common)• Substitution• Masking agents
02 Eliminates DrugTest Cheating
9
How Well Does Oral Fluid Testing Hold Up in Court?
Rockland Cty v. NY Family
Medina Cty v. Hixon
Medina Cty v. Hixon 2
Frye Rule
Chain of Custody. Ruling demonstrates judicial recognition and acceptance of scientific and persuasive evidentiary value of Intercept results.
Performance. Ruling demonstrates judicial recognition and acceptance of scientific and persuasive evidentiary value of Intercept results.Lab Procedures. Testimony of both screen and confirmation demonstrated 99.5% accuracy in results to withstand counterclaim..
Admissibility. General consensus of the scientific community that a given technique is reliable. Oral fluid drug testing withstands the legal scrutiny.
Court Decisions
Did You Know?In U.S. federal courts, admissibility of scientific evidence is governed by the 1975 Federal Rules of Evidence.
04 Safeguards LegalDefensibility
Intercept® Oral Fluid Test
10
Not all oral fluid tests are alike
Recognized Brand in Oral Fluid Testing
• FDA cleared drugs of abuse oral fluid testing system
• On-site collection – laboratory analysis
• Collection pad and handle• Low level of salts on pad to help
generate oral fluid• Easy grip handle with ‘flag’
serves to show correct orientation in mouth
#1
Intercept® Oral Fluid Drug Test
11
Not all oral fluid tests are alike
Specimen Integrity Ensured for up to 21 Days• Specimen vial
• Preservative stabilizes sample for shipment• 21 day stability before testing
• Designed to accommodate tamper seal
Snap SealSwab
Ease of collection:3 easy steps
Oral Fluid Collection Process is Fast and Easy
12
Using the OraSure Intercept® Device
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Intercept® Oral Fluid TestCommon drug panels
Assay Menu• Marijuana (parent THC)• Cocaine• Opiates• Amphetamine• Methamphetamine including
MDMA (Ecstasy)• Phencyclidine (PCP)• Barbiturates• Benzodiazepines• Methadone• Oxycodone
Other: Cotinine (Tobacco assessment)
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Ask about expanded panels with your laboratory
Dignified collection Gender neutral No dedicated facility for
onsite collections
Reduce time away from work for high wage employee collections
Reduce time away from work for high wage employee collectors
No collection fees Reliance on collection site
hours/locations No “NO” shows
Dignified
Reduce Employee Time Away From Work
No Need for Collection
Site
Oral Fluid Value
Removes Same Sex Collector Need
Improves Testing Attitudes
Establishes MarketCompetitiveness
ImprovesProductivity
Saves Time and Money
14
Why Intercept® Oral Fluid Drug Testing?Collect anytime / anywhere
Drug Users are in the Workplace
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76%Drug users are currently employed
Estimated cost to U.S. employers per year
276BillionYear
What is Synthetic Marijuana?
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The “Not for Human Consumption” Fake Weed
Overview: Dried plant material sprayed with synthetic additives; 4 - 50Xs more potent than THC.
Marketed: Sold as incense that can be smoked. Resembles potpourri.
Street names: K2, Blaze, Spice, Red X Dawn, Bliss, Black Mamba, Fake Weed.
Affect: Similar to THC: paranoia, panic attacks, giddiness to heart attacks.
Did You Know?It’s Not Just for Kids. SAMHSA estimated 28,500 ED visits in 2011 alone. Recent Users’ Median Age: 35 years old.
2%Positivity rate
Many employers have added to their drug panels.
UpTo
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Opioid PrescriptionsIt’s a national addiction problem
Did You Know?By 2009, Americans consumed 99% of the worldwide production of hydrocodone and 81%of oxycodone. Over 12.2 million Americans reported using non-medically.
96 - 143
82.2 - 95
72 – 82.1
52 - 71
2012 Number of OpioidPrescriptions per 100 People
Heroin Deaths Surpass Gun Homicides in 2015
Did You Know?Oral fluid testing detects the primary heroin metabolite 6-AM more effectively than urine and hair.
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Fentanyl – The King of Synthetic Opioids
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100 times more potent than morphine
Overview: Synthetic opioid analgesic used to treat severe pain. Street fentanyl is disguised or often laced in heroin.
Marketed: Prescription patch or pills disguised as oxycontin.
Street names: Fake Oxy, greenies, green beans and green monsters.
Affect: Euphoria, increased energy, distorted perception to liver & kidney failure, and death.
Did You Know?Ohio has the highest testing rate incidents. Fentanyl reports increased 72Xsin just 5 years.
73%Increased death rate
From 2014 to 2015.
Have You Seen Molly?
20
MDMA (Ecstasy) - NOT the girl next door.
Overview: Synthetic modified amphetamine drug in pill or capsule form typically taken with other substances.
Marketed: Often blended with other drugs such as bath salts.
Street names: Ecstasy, molly, dancing shoes, hug drug, Scooby snacks.
Affect: Euphoria, increased energy, distorted perception to liver & kidney failure, and death.
Did You Know?Since 2012, MDMA positivity rates has increased 5X in the workplace.
6.8%Surveyed Individuals
Have tried MDMA at least oncein their lifetime.
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2 Amtrak Worker’s Killed
Amtrak Accident, Chester, PA – April 3, 2016Engineer’s post-accident drug test positive for THC & worker positive for opioids
30Million
Estimated damagestrain and tracks
Additional injury lawsuitspending!
• A 106mph train collided with a backhoe doing work on the tracks: • 2 Amtrak workers killed• 341 passengers were on board
• Cause of accident: miscommunication • Tested positive for drugs:
• Engineer – marijuana• Worker #1 – cocaine• Worker #2 – opiates
22
2 Employees Collapse on the Job
BMW Plant, Munich, Germany – March 3, 20172 employees and their smoked joint shuts down assembly line
1+Million
Estimated cost for 40 minute shut down
Additional off-site medicalexpenses
• 2 employees smoked a joint in locker room prior to evening shift
• Collapsed on the job shutting assembly down
• Tested positive for drugs:• Worker #1 – THC & alcohol• Worker #2 – THC & amphetamine
Source: Bild Report, March 20, 2017
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1 in 9 construction employees abuse illicit drugs
Construction IndustrySecond highest rates of substance abuse in the workplace
Construction workers abuse illicit drugs
• 3 out of 4 construction managers perceive substance abuse to be a serious problem
• Construction accounts for the highest rate of accidental fatalities of any industry – 51.8%
• 4.4% of employer compensation costs in construction were spend on workers’ compensation; nearly 3 times more compared to all other industries
• Drug-testing programs result in 51% reduction in incident rates within 2 years of implementation in9
Required…DOT, contractor
screening, co-employment
Hiring assessment for a better candidate
Deter drug use in the workplace
Detect useReduce common business costs
(health insurance,
worker’s comp, etc.)
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Why Does a Company Drug Test?Motivational influencers
It may be one or many
Who is Drug Tested?
1%
2%
2%
2%
16%
83%
Office-based employees
Client-facing employees
Supervisors / managers
Employees with financialresponsibility
Employees operatingmachinery/tools/vehicles
All employees
57%
25
Employers performdrug testing
Fewer employers in the New England area (-18%)
Which part of your workforce is drug tested?
2017 National Safety Council Employer Survey
26
Drug Testing Works!Annual positivity rates
States That Have Legalized Marijuana
Did You Know?Oral fluid testing detects recent use of marijuana ruling out the “PAST USE” excuse.
27
Legalized for medical use only
Legalized recreational & medical use
No broad laws legalizing marijuana
Should I still test for Marijuana?
Should I still test for
Marijuana?
28
Be clear in the company policy Define prohibited behaviors Establish drug testing protocol (how,
when and for what drugs) Identify consequences for policy
violations Be clear that employees cannot
possess or use marijuana in the workplace or be under the influence
Define “Under the Influence” policy Indicate detection of any amount is a
violation of company policy Take measures based upon actions
rather than drug test results (reasonable suspicion)
Best Practice
Should I Still Test for Marijuana?It’s still an illegal substance under federal law
In August 2016, DEA stated marijuana will remain a Schedule I drug.
Schedule I Controlled Substance01
Courts have ruled in favor of employers stating that marijuana is not protected as a lawful off-duty activity and is illegal under federal law.
Court Ruling02
Employers have the right to prohibit use or impairment in the workplace. U.S. DOT and other federal employers still require testing for marijuana.
Employers Rights03
Should I still test for
Marijuana?
29
Testing is a single assessment data point of employees or candidates and reveals the following:
Does or doesn’t use the drug Gave up long enough to get
a job Doesn’t make risky decisions
when in a workplace that tests Researched the company’s drug
testing policy Has a habit that she / he couldn’t
stop Wants to tell you why it should
be legal
Employee Assessment
Should I Still Test for Marijuana?Here’s what testing can reveal about your employee / applicantShould I still
test for Marijuana?
WORKPLACE IMPACT
Performance Inconsistent quality Lower productivityPoor concentration and focus
Absenteeism / Medical ExpensesUnexplained disappearancesExtended lunch periods and
early departures Increased healthcare expenses
AccidentsNeedless risk takingDisregard for safety of self / othersDriver accidents
TESTING OUTCOMES
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Should I Still Test for Marijuana?Impact and outcomes shouldn’t be surprising
Performance Increase stability Increase productivity Increase moral
Absenteeism / Medical ExpensesReduce employee absencesReduce employee turnoverDecrease healthcare costs
AccidentsSafer work environmentDecrease workman’s
compensation $Decrease litigation expensesDecrease tax liability
Should I still test for Marijuana?
Should I still test for Marijuana?
Should I still test for
Marijuana?
What are Employers Saying About THC?
31
75%Concerned Employers
Decrease of quality of new/hires in workplace.
98%Will Continue
to Test for THC
Should I still test for
Marijuana?
0123456789
2009 2010 2011 2012 2013 2014 2015 2016Urine Oral Fluid Hair
32
%%%%%%%%%%
ColoradoAmendment
64
WashingtonInitiative
502
CaliforniaBill Prop
64
Marijuana Positivity RatesHere’s how recreational marijuana is effecting the general workforce
Did You Know?Since 2012, oral fluid drug testinghas realized double-digit positivity rate increases among the general workforce.
How accurateis oral fluid
drug testing for THC?
Lab-based Oral Fluid vs. Urine Drug Testing
Drug Test Urine Analysis (%)
Oral Fluid Analysis (%)
Marijuana 2.5 8.9
Cocaine 0.28 0.63
Amphetamine 1.20 0.66
Opiates 1.197* 0.71
PCP 0.01 0.05
Methamphetamine n/a 0.42
33
Positivity rates – general workforce samples (non-regulated)*
Overall Positivity
Oral fluid THC positives were greater than urine positives in 2016.2.5Xs
How accurateis oral fluid
drug testing for THC?
Oral Fluid Lab-based vs Rapid Testing
34
80%Marijuana Positives
Below 50 ng/mL oral fluid cutoff(65% of all THC positives are below 25 ng/mL)
20%Marijuana Positives
Above 50 ng/mL oral fluid cutoff
50 ng/mL
Rapid TestDetection RangeLab-based Test
Detection RangeN=2407
How accurateis oral fluid
drug testing for THC?
ABOUT USLab-based Urine Testing
PROS CONS
35
PROS
Considered the standard in drug testing. Allowed in Federal and DOT testing. Provides an electronic chain of custody for DOT and non-DOT. ~18,000+ collection sites. Variable costs depending on the collection site.Variation of drug panels including MedPro.Upheld in courts, widely accepted in most states and programs.
CONS
Adulteration or dilution 1 to 3% requiring retesting along with delayed hiring.Requires direct observed collection and/or dedicated bathroom facility.Requires special training.Window of detection does not detect near term use impacting pre-employment testing in the era of legal marijuana, post-accident/reasonable suspicion for impairment testing.Gender specific collections. Embarrassing for donor. May not meet ADA compliance for shy bladder donors.
How does oral fluid compare with other test types?
ABOUT USRapid Urine Testing
PROS CONS
36
PROS
Instant results for determining negative results quickly.
May be conducted by trained personnel on-site.
Less expensive compared to lab-based tests. Offers various test panel combinations
CONS
Complex collection procedures.
Results are interpreted by supervisors.Inconsistent tracking of results.
Requires special facilities for on-site collections.Prohibited in several states.
May not meet ADA compliance with bladder shy donors.
The “Yuck” factor
How does oral fluid compare with other test types?
Building Blocks of an Oral Fluid Program
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5 basic elements –8 easy steps
How can I switch to oral fluid testing?
3. Choose a labEven if you have a laboratory, work with your provider to review current
and any future panel needs.2. Update your policyEnsure that the panels are accurate, testing method includes lab-based oral fluid.
4. Confirm your inventory needs
Use your real testing data and device expiration to decide how
many and how often to order.
1. Review your policyConfirm that you are able to use lab-based oral fluid in your state.
Making the Switch
38
8-easy steps to save valuable time and moneyHow can I switch to oral fluid testing?
7. Set a DateSet a date for training and
allowances for implementation.6. Provide MaterialsProvide reference materials for your managers and staff.
8. Schedule anevaluation
Schedule time with your provider post roll out to evaluate program
effectiveness (30, 60, 90 rule).
5. Customize trainingDevice training will be provided by your manufacturer. Be sure to review your program as well.
Making the Switch
39
8-easy steps to save valuable time and moneyHow can I switch to oral fluid testing?
Q.E.D.® Saliva Alcohol Test
Accurate Results With 98% Correlation to Blood GC• Accurate results in 2 minutes• Built in QA Spot• Confirmed with breath/blood• DOT-approved• FDA-cleared• CLIA-waived
Q.E.D.® Saliva Alcohol Test
• QA Spot™
• Result scales(0-145 mg/dL)
• Capillary
• Entry port
The First DOT-approved, FDA-cleared, CLIA-waived Saliva Alcohol Test
Insert ReadSwab
Ease of testing:3 easy steps
Oral Fluid Testing Process is Fast and Easy
42
Using the Q.E.D.® Saliva Alcohol Test
1100 Walnut St. Ste 3010Kansas City, MO 64106
Contact Numbers:(800) 374-7798
Email Address:[email protected]
Thank You
