the value of oral fluid drug testing in the workplace/media/3e6d8e7fec754064bded36546b...lab-based...

The Value of Oral Fluid Drug Testing in the Workplace

Oral Fluid Screening Solutions

2045 INT0197 0212 ValueWorkplace_Layout 1 3/8/12 4:39 PM

The Value of Oral Fluid Drug Testing in the Workplace2

In a challenging economy, can employers really

afford to continue drug testing employees and

job applicants? That seems like an appropriate

question to ask. But an even more pertinent

question might be: can you afford NOT to

conduct drug testing?



The challenges of todayDrug testing has become an important safety issue in the workplace for human resources and safetyprofessionals, as approximately 75% of all drug abusersare employed either full or part time.1 As a result, themajority of companies surveyed today perform someform of drug testing in their establishments.2

The purpose of drug testing is to lessen the impact fromdrug abuse in the workplace, including accidents,tardiness, absenteeism, turnover, attitude problems,theft, decreased productivity, and crime and violence.The U.S. Department of Labor estimates that drug use in the workplaces costs employers $75 to $100 billionannually in lost time, acccidents, healthcare andworkers’ compensation costs.3 According to TexasBusiness Today, approximately 65% of all accidents onthe job are related to drug or alcohol, with substanceabusers impacting 80% of non-abusers. Finally, drugabusers account for 38% to 50% of healthcare benefitsand are 5 times more likely to file workers’compensation claims than non-abusers.4

Current testing modalitiesTraditionally, urine collection has been the primary,long-standing sample type used, since it is less invasiveand far less expensive than drawing blood whichotherwise would be the optimal specimen type. While testing for drugs with hair is an option, thismethodology will not detect drug use for the first 7-10 days and will report positive drug use for far too long to be effective in most workplace drug testing programs.5

The act of voiding a urine specimen is generally viewedas humiliating. It is also generally believed that urine isdirty and can make a person cringe at having to handleeven a sterile specimen cup when presented at theworkplace. Shy bladder often occurs when a person isasked to produce a sample, further delaying theprogram. Shy bladder syndrome can be amplified whengoverning procedures dictate that the collection bewitnessed. Witnessed collections add to the humiliationof the worker and can add stress. Urine testing has alsobeen known to be easily adulterated, substituted, ordiluted, leaving the door wide open to anyone who mayhave a predisposed want or need to cheat a test.Collecting and testing urine or sending an employeeoffsite to be tested has its drawbacks, but it has becomea necessary deterrent to drug abuse in the workplace.

Windows of Detection5


About 10 years ago, the science of drug testing took ona new face. Oral fluid drug testing had been making itsway into the scientific community. The life insuranceindustry had already been using oral fluid to test formarker drugs, like cocaine and cotinine (the metaboliteof nicotine), for over a decade. Seeing the necessity for a less invasive, accurate method for testing otherdrugs, OraSure Technologies pioneered and fine-tunedlab-based testing assays for the major drugs utilizingoral fluid. These tests have been used effectively in theworkplace, drug treatment, and criminal justice industries.

Oral fluid collection overcomes all of the drawbacks ofurine collection and has proven to be just as competent.Drug content in oral fluid closely mirrors that in bloodand can be tested for parent drugs and metabolites,which cannot be done with urine. This allows oral fluidto be considered as an “under the influence” indicator aswell. Collections can be done anywhere, anytime,without having to deal with the embarrassment ofurine. Collections are easily observed without stress oneither party. Some workplaces who have adopted oralfluid testing will even collect from an entire group using only a few observers, allowing more time forinterviews and hiring decisions.

With its easily observed collection, sample substitutionor sample adulteration is eliminated. Oral fluid tests arealso impervious to dilution tactics or any of the

currently available masking agents or washes. Although,many websites give advice and/or sell products to cheatdrug tests, none have a proven method for cheating anoral fluid test. One of the many sites,www.wikihow.com/pass-a-drug-test, states:

“Try to avoid the test [oral fluid]. If one is being tested andhas used in the past 3 days you will need to overcome thesaliva collection. To do this you will have to avoidsubmitting saliva and perform the steps requested of youby the instructor.”

Another offers this advice:

“To pass this [an oral fluid test] you should always knowthe detection time of the drug you have taken. Marijuanacan be detected via saliva drug testing from an hour afteringestion up to 24 hours depending on use. Between theseperiods of time, you must avoid being screened or you willsurely test positive.”

With more than a decade of scientific and legal scrutiny,oral fluid has grown considerably in usage as variousindustries have discovered the important benefits andutility of oral fluid collections.



SAMHSA-5 Drug Panel Intercept® Urine Analysis1

Overall positive rate 4.1% 4.4%

Amphetamine 0.17% 0.42%

Methamphetamine 0.24% 0.17%

Cocaine Metabolite 0.82% 0.58%

THC 2.5% 2.3%

Opiates2 0.60% 0.35%

PCP 0.02% 0.02%

Sample, et al, Positive Prevalence Rates in Drug Tests for Drugs of Abusein Oral-Fluid and Urine, SOFT 2010. 1 Includes test results for other “non-SAMHSA-5” drugs such as

barbiturates and benzodiazepines.2 ~50% OF and ~8% Urine Opiates included hydrocodone andhydromorphone.

N=4.59 million Intercept® Devices.

But what are the cons of oral fluid testing?There has to be some give and take, right? Urine has been the gold standard in drug testing for30+ years, and change is not easy for manyorganizations. There are many misconceptions thatpersist about oral fluid drug testing – most of themhave been dispelled in scientific literature, but they stillcontinue. (See www.ChooseIntercept.com for a whitepaper on The Myths and Facts of Oral Fluid Testing.)Although the window of detection for oral fluid isslightly shorter than that of urine, oral fluid testing candetect drugs sooner (within 1 hour of use), and all thepublished data suggests that the positivity rates arecomparable.6



Another misconception that persists is that oral fluidtests do not adequately detect marijuana (THC). Thisapplies to point-of-care tests (POCTs), not lab-basedoral fluid tests (see chart above). Lab-based oral fluidtests such as the Intercept® device cross-reacts with theparent drug for THC at very low cutoff levels (1 ng/mL).Point-of-care or instant oral fluid tests cross-react atmuch higher levels (typically 50 ng/mL or higher),making the window of detection for THC much shorterthan lab-based oral fluid tests. Based on data fromQuest Diagnostics, most positive THC samples fall in the< 20 ng/mL range, which is below the detection rangefor instant oral fluid drug tests.7

The FDA has not cleared any rapid devices for testing,primarily due to the THC detection limitation. However,there are several FDA-cleared lab-based products on themarket today, including the Intercept® test.

Consider the following when evaluating testingmethodologies for an addition to or replacement inyour testing toolbox:

1. Is the test accurate?

2. Is the test susceptible to cheating?

3. Is the dignity of the employee protected?

4. Is the test cost-effective to my drug testingprogram?


0

100

200

300

400

500

600

<500<350<200<95<80<65<50<35<20<5

Num

ber o

f Sam

ples

THC Concentration (ng/mL)

<650

Detection range of oral fluid POCTs

80% of THC positives are below a 50 ng/mL oral fluid cutoff.


AccuracyStart researching products by looking on the FDA’swebsite to see which products have FDA clearance.Other web searches should uncover independent,empirical data from peer-reviewed publications. Thesearticles always disclose the devices and manufacturer ofthe testing elements used in the study. A comparison of the product’s package insert data to the independentstudies data can be quite revealing.

Once research has been satisfied, a call or visit to themanufacturer’s website can uncover a history ofsatisfaction with long-standing users. If this informationis not readily available, ask for referrals. These referencesshould be able to give guidance in knowing thecompany and individuals you are dealing with, howthey interact with your laboratory, and how they canassist in any issues encountered.

Cheating

Drug testers are full of stories about people trying tocheat their drug test. Companies are are familar to thesesometimes absurd antics. It has been well documentedthat urine testing is suspect to cheating. Manylaboratories have added adulterant or dilution tests totheir standard drug-testing packages. (Note: These costsare an added cost factor from the laboratory and mosttimes invisible during contract negotiations). Lab-basedoral fluid tests are very difficult to adulterate due toease of observation and the fact that other tactics haveproved ineffective.


FDA-510K Cleared Assays8

Lin-ZhiAssay Menu Intercept® Oral-Eze® Quantisal™ International

Amphetamine ✓ ✓ ✓ ✓Methamphetamine (Including Ecstasy) ✓ ✓ ✓ ✓Cocaine/Metabolite ✓ ✓ ✓ ✓Opiates ✓ ✓ ✓ ✓Marijuana (THC) ✓ ✓Phencyclidine ✓ ✓Barbiturates ✓Benzodiazepines ✓Methadone ✓

*Not Approved for Ecstasy

*


DignityNo urine, no bathroom … no collection fees, no scheduling inconveniences for collections, and, if managed onsite, no humiliating observedcollections, no gender match-up issues, no threats ofdrug test cheating.

With oral fluid collection, the employee andadministrator/employer observe the collectiontogether, so the specimen never leaves the employee’ssight alleviating legal challenges or the employer’s sightremoving adulteration attempts. Collections can bedone anytime, anywhere, to maximize productivity andhiring timelines.

Cost-effectiveness

When comparing test costs from one brand ormethodology to another, it requires more than just adirect assay-to-assay and/or collector-to-collector costcomparison. The invisible “soft” costs commonlyoverlooked should become part of the evaluation.

With urine testing, one “soft” cost is the amount of timeaway from work for collections, or the number of days itmay take to make a hiring decision. Another overlookedcost is accounting for the number of tests rejected bythe lab due to adulteration or dilution but for which thelab will still bill. A new specimen will have to besecured, doubling both effort and direct laboratory

costs. It’s not uncommon that more than 5% ofcollected urine specimens are rejected based ondilution, adulteration or insufficient volume.9

In addition, “hidden” administrative costs include theneed to have gender-specific personnel to manage adrug collection if performed onsite and/or any specialcosts associated with the collection facility (i.e.dedicated bathroom).

All these costs can increase exponentially when dealingwith employees and a drug testing program.


Reduces Employee Downtime

Urine Collection Model

Travel Deliver Return

15 minutes 15 minutes 15 minutes

Intercept® Oral Fluid Model

Travel Deliver Return

None 5 minutes 5 minutes


One last question –Will oral fluid work for my organization?Objectively you must answer, “It depends.”

• It depends on your organization’s objectives.

• It depends on the circumstances under whichtesting is administered.

• It depends on where testing occurs.

• It depends on applicable state and federal laws.

Overall, the general answer would be YES.

Advantages of oral fluid testing:

1. Flexible – sample can be collected anytime,anywhere

2. Legally defensible as technology is widelyconsidered reliable

3. Scientifically accurate

4. More accurate method in measuring “recent” use

5. Easy to administer and often preferred by thosewho administer tests

6. Minimal lost work time

7. Hiring faster process

8. Less embarrassing collection process for the donor

9. Fewer scheduling inconveniences and collection fees

10. Virtually adulteration proof


Facilitates Faster Hiring Decisions

Urine Collection Model

Monday Tuesday Wednesday Thursday Friday

Offer Collection Site Result(48 hrs. to report)

Intercept® Oral Fluid Model

Monday Tuesday Wednesday Thursday Friday

Offer Result



The OraSure differenceAs the innovators in oral fluid drug testing, OraSureTechnologies has led the oral fluid drug testing industryand the scientific community with the research and toolsthat have pioneered this highly accurate and efficientmethod of testing for drugs of abuse.

Our long-established expertise in oral fluid drug testingdelivers trusted and reliable value to our customers whileworking in partnership towards a common goal.

Our dedicated field-based consultants are available toanswer any questions you may have, assist with yourtraining efforts, and provide the necessary support andexpertise for your drug testing programs and policies.

Partner with OraSure and the Intercept® brand for yourOral Fluid Drug Testing Needs…a Reliable and TrustedBrand for Over 10 Years.



References / Resources1. SAMHSA. Workplace Substance Use: Quick Facts toInform Managers. 2008.

2. Society for Human Resource Management (SHRM).Background Checking: Drug Testing Survey Results,January 22, 2010.

3. Ying-Tzu Lu and Brian H. Kleiner. Drug Testing in theWorkplace. Management Research News, Vol. 27:4/5, pp.46-53 (2004).

4. NIDA. Strategic Planning for Workplace AbusePrograms, 2002.

5. NIDA. New Developments in Biological Measures ofDrug Prevalence. Monograph 167, 2000.

6. Sample et al. Positive Prevalence Rates in Drug Tests forDrugs of Abuse in Oral Fluid and Urine, SOFT 2010.

7. Quest Diagnostics. Data on File.

8. The Intercept® oral fluid drug testing system is cleared by the FDA and filed with the following numbers:

FDA Clearance Intercept® 510K Numbers Device/Assay

K011057 Oral Fluid Collection DeviceK992918 Amphetamine Specific MicroplateK001976 Barbiturates MicroplateK013882 Benzodiazepines MicroplateK002375 Cannabinoids MicroplateK001197 Cocaine MicroplateK002010 Methadone MicroplateK993208 Methamphetamine MicroplateK981341 Opiates MicroplateK000399 PCP Microplate

9. How Does Substance Abuse Impact the Workplace?U.S. Department of Labor elaws–Drug Free WorkplaceAdvisor. http://dol.gov/elaws/asp/drugfree/benefits.htm,accessed Jan. 13, 2012.

Government Resources:Substance Abuse and Mental Health ServicesAdministration (SAMHSA):http://www.samhsa.gov/

National Survey on Drug Use & Healthhttp://oas.samhsa.gov/nsduhLatest.htm

Substance Abuse Screeninghttp://store.samhsa.gov/facet/Treatment-Prevention-Recovery/term/Substance-Abuse-Screening?headerForList=

Centers for Disease Control and Prevention (CDC):Illegal Drug Usehttp://www.cdc.gov/nchs/fastats/druguse.htm

National Institute on Drug Abuse (NIDA):http://www.nida.nih.gov/nidahome.html

Department of Labor (DOT):Working Partners for an Alcohol and Drug-FreeWorkplacehttp://www.dol.gov/asp/programs/drugs/workingpartners/dfworkplace/dfwp.asp

Procedures for Transportation Workplace Drug andAlcohol Testing Programs - DOT rule, 49 DFR part 40http://www.dot.gov/ost/dapc/NEW_DOCS/part40.htm


The Value of Oral Fluid Drug Testing in the Workplace© 2012 OraSure Technologies, Inc. Intercept® and Q.E.D.® are registered trademarks of OraSure Technologies, Inc. INT0197 (rev. 02/12)

The Value of a Reliable and Trusted Brand

To learn more about OraSure’s fine line of oral fluid testing tools, go to

ChooseIntercept.com or call 1-800-ORASURE.


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