Oral Fluid Report 646833 7
Oral Fluid Report 646833 7
Oral Fluid Report 646833 7
PILOT PROGRAM
FEBRUARY 2019
ORAL FLUID ROADSIDE ANALYSIS PILOT PROGRAM
Pursuant to the reporting requirements of Public Act 243 of 2016, this report that details the
findings of the Oral Fluid Roadside Analysis Pilot Program has been prepared for submission to
the Senate Judiciary and Public Safety Committee and the House Judiciary Committee. This report
contains all the minimum requirements listed in Public Act 243 of 2016, along with the statistical
data relating to the outcomes of the oral fluid test instrument, comparative voluntary oral fluid
sample independent laboratory analyses, and Michigan State Police (MSP) Forensic Science
Division (FSD) evidentiary blood analyses.
This report is presented on behalf of the subject matter experts who were assembled to serve on
the Oral Fluid Roadside Analysis Pilot Program Committee.
Michigan law states that a person cannot operate a vehicle while under the influence of alcoholic
liquor, a controlled substance, or other intoxicating substance or a combination of alcoholic
liquor, a controlled substance, or other intoxicating substance (Legislature Service Bureau, 2019).
Over the last ten years in Michigan, drug-impaired driving has become more prevalent and traffic
fatalities have increased.
According to the MSP Criminal Justice Information Center, 98 people lost their lives in drug-
impaired driving crashes in 2007. By 2017, drug-impaired traffic fatalities had increased by 151
percent to total 246 fatalities resulting from drug-impaired crashes in Michigan (Michigan State
Police [MSP], 2018). Nationally, drugged driving is gaining attention due to increased prescription
drug abuse and recent cannabis legalization (Veitenheimer & Wagner, 2017). In 2014, 10.1 million
people 16 years of age and older reported driving under the influence of drugs within the past
year in the United States (Veitenheimer & Wagner, 2017).
Currently, police officers in Michigan do not have instruments available for use on the roadside
to assist with establishing probable cause pursuant to operating while impaired investigations,
despite oral fluid preliminary screening devices becoming more robust and reliable (Stefano,
Solimini, Tittarelli, Mannocchi, & Busardo, 2016).
Preliminary oral fluid drug screening on the roadside has many benefits. Studies have shown that
drugs accumulate in the oral fluid by passive diffusion from the blood (Cone & Huestis, 2007).
Certain drugs tested in oral fluid are well correlated with positive results from the same drug
when tested in the blood (Moore & Miles, 2015). Collecting oral fluid from a driver on the roadside
can be easy, quick, and non-invasive. There is limited risk of adulteration with the oral fluid sample
and the collection is painless (Edwards, Smith, & Savage, 2017). Oral fluid collection can occur at
the scene, close to the time the driver was operating a vehicle (Moore & Miles, 2015). The oral fluid
test instrument provides the investigating police officer positive or negative test results, within five
minutes, on recent drug intake (Alere Toxicology, 2019).
Michigan law states, “The amount of alcohol or presence of a controlled substance or other
intoxicating substance in a driver’s blood or urine or the amount of alcohol in a person’s breath
at the time alleged as shown by chemical analysis of the person’s blood, urine, or breath is
admissible into evidence in any civil or criminal proceeding and is presumed to be the same as
at the time the person operated the vehicle” (Legislative Service Bureau, 2019). An evidentiary
chemical breath test is typically used to determine if a driver is impaired by alcoholic liquor. Both
evidentiary blood and urine are generally used to determine identification and quantification of
a controlled substance or other intoxicating substance. The Toxicology Unit of the MSP Forensic
Science Division analyzes evidentiary biological (blood and urine) specimens. The Toxicology Unit
tests approximately 16,000 evidentiary blood cases for the presence of alcohol, and approximately
5,500 cases for the presence of drugs per year (MSP, 2019). Evidentiary urine was tested by the
Toxicology Unit approximately 140 times per year; the vast majority of which were not related to
impaired driving investigations (Bowen, personal communication, January 16, 2019).
Blood is considered the “gold standard” for drug analysis in driving under the influence of
drugs (DUID) cases (Moore & Miles, 2015). However, there are some drawbacks to utilizing
blood for evidentiary purposes. Obtaining a blood sample from a driver requires transporting
a driver to a hospital to have blood drawn by a medical professional, which can take several
hours, especially if the impaired driver does not consent to a blood draw and a search warrant
must be obtained. Some drugs, such as ∆⁹-tetrahydrocannabinol (THC) the most psychoactive
of the principal constituents of marijuana, metabolize quickly within the body (Hartman, et al.,
2016). The loss of THC in-vitro must be taken into consideration when analysis of cannabinoid
positive blood samples is not immediate (Scheidweiler et al., 2013). Further, securing a blood
sample requires phlebotomy or puncturing the skin with a needle. This process, also known as
venipuncture, is considered invasive (Yamada, Yamada, Katsuda & Hida, 2008). Blood analysis
may take several weeks to complete and despite efforts to preserve the blood in the test tube
by using preservatives and optimizing storage conditions, some drugs inevitably break down
and/or metabolize over time. One example of this is when cocaine breaks down into its primary
metabolite, benzoylecgonine (Peaire, et al., 2017).
Utilizing oral fluid for preliminary drug screening has the potential to expedite the drug-impaired
driving investigation process. Since oral fluid has a short drug detection window, it makes an ideal
specimen to collect (Veitenheimer & Wagner, 2017). Oral fluid is collected very close to the time
the driver was operating a vehicle, lending additional credibility to the test results and drivers may
be more inclined to consent to a non-invasive oral fluid swab versus a blood draw.
A Feasibility Study of Roadside Oral Fluid Drug Testing concluded that officers preferred oral fluid as
a test medium, over sweat or urine, due to the ease of collection and its minimally invasive nature
(Asbridge & Ogilvie, 2015).
On March 20, 2013, a traffic crash at the intersection of US-2 and South Hill Road in Gladstone,
Michigan took the lives of Thomas and Barbara Swift of Escanaba. The couple died of injuries
sustained when their vehicle was struck by a semi-trailer truck that disregarded the red light at the
intersection and collided with their vehicle (Truck Driver Sentenced in Gladstone Fatal Crash, 2014).
The driver of the at-fault semi-trailer truck was charged with six felonies in connection to the fatal
crash: two counts of operating a motor vehicle with the presence of a controlled substance causing
death (THC); two counts of reckless driving causing death; and two counts of operating with a
suspended license causing death (Gwinn Truck Driver Charged in Deadly Accident, 2013). Following
a trial, the jury found the driver guilty on all six felonies and he was sentenced to a minimum of five
and a half years in prison (Marquette County Man’s Appeal Denied in Fatal Crash Case, 2015).
Following the loss of his parents, Brian Swift contacted Senator Thomas Casperson who
introduced Senate Bill 207 and Senate Bill 434 to combat drug-impaired driving by implementing
an oral fluid roadside analysis pilot program. Both bills passed the Michigan House of
Representatives and Michigan Senate and were signed into law by Governor Rick Snyder. Public
Act 242 and 243 of 2016, known as the Barbara J. and Thomas J. Swift Law, became effective on
September 22, 2016.
The MSP was tasked with developing a written policy and authorized to promulgate administrative
rules as necessary for the implementation of the roadside oral fluid testing pilot program
(Legislative Service Bureau, 2015).
A DRE participating in the pilot program shall order out of service, a person who was operating a
commercial motor vehicle and who refuses to submit to a roadside oral fluid test. The DRE shall
advise a commercial vehicle operator that refusing to submit to a preliminary roadside oral fluid
test request is a civil infraction and will result in the issuance of a 24-hour out-of-service order
(Legislative Service Bureau, 2015).
The Oral Fluid Roadside Analysis Pilot Program Committee researched the capabilities of several
A DRE
models of oral fluid participating
test instruments in the pilot program shall
by manufacturers order
that out of service,
included: a person who
Noble, Securetec, was operating a
Oranoxis,
Protzek, Abbottcommercial motorToxicology),
(formerly Alere vehicle and SmartTox,
who refusesandto submit to a roadside oral fluid test. The DRE shall
Draeger.
commercial vehicle operator that refusing to submit to a preliminary roadside oral fluid test reque
Each instrumentcivil
wasinfraction
evaluatedandwith
will result
a goalinofthe issuance
selecting anofinstrument
a 24-hour out-of-service
that includedorder
the (Legislative Service
following criteria:
2015).
• PortableRoadside
handheldOral instrument for ease of use in the field
Fluid Test Instrument
• Rechargeable andFluid
The Oral fullyRoadside
automated Analyzer
Analysis Pilot Program Committee researched the capabilities of severa
of oral fluid test instruments by manufacturers that included: Noble, Securetec, Oranoxis, Protzek
• On-screen instructions
(formerly Alere Toxicology), SmartTox, and Draeger.
• Results within 5 minutes or less
Each instrument was evaluated with a goal of selecting an instrument that included the following
• THC cutoff level no higher than 25 ng/ml
• Includes an on-board
• Portable handheld
heater instrument
to ensure tests for
runease of use in
at optimal the field
temperature
• Rechargeable and fully automated Analyzer
• Battery life capable of running
• On-screen up to 50 tests
instructions
• Printer included
• Results within 5 minutes or less
with device
• THC cutoff level no higher than 25 ng/ml
• Collection device separate
• Includes anfrom test cartridge
on-board heater to ensure tests run at optimal temperature
• Battery
• Collection device life capable
has a volume of running
adequacy up to 50 tests
indicator
• Printer included with device
• Capacity to retain at least device
• Collection 1000 test records
separate from test cartridge
• Oral fluid sample
• Buffer solution integrated collection
with test device must have volume adequacy indicator
cartridge
• Capacity to retain at least 1000 test records
• Positive and•Negative
Buffer quality
solutioncontrol
integrated(QC) cartridges
with included with instrument
test cartridge
•
• Minimum test panel Positive and Negative
to include: quality control
amphetamines, (QC) cartridges included
methamphetamines, with instrument
opiates,
• Minimum test panel
cocaine, benzodiazepines, and cannabinoids to include: amphetamines, methamphetamines, opiates, cocaine,
benzodiazepines, cannabinoids
After manufacturer presentations, the Committee selected the Alere DDS2 test instrument.
After manufacturer presentations, the Committee selected the Alere DDS2 test instrument pursua
pilot project.
The Alere DDS2 oral fluid test instrument is capable of testing for the below six drug classes
(cut-off levels are
Theestablished
Alere DDS2byoral
thefluid
oraltest
fluid test instrument
instrument manufacturer).
is capable of testing for six drug classes.
Cocaine 30
Methamphetamine 50
Opiates 40
Cutoff levels are established by the oral fluid test instrument manufacturer.
ORAL FLUID ROADSIDE ANALYSIS PILOT PROGRAM · FEBRUARY 2019 6
At the beginning of each shift, the DRE will perform negative and positive quality control checks w
oral fluid test instrument. These performance checks are done prior to each shift to ensure the in
PROCEDURES FOR THE USE OF
ROADSIDE ORAL FLUID TEST INSTRUMENT
At the beginning of each shift, the DRE is required to perform negative and positive quality control
checks with the oral fluid test instrument. These performance checks are done prior to each shift
to ensure the instrument is functioning properly.
The nanogram per milliliter (ng/mL) in oral fluid is much different than the equivalent ng/mL in
blood. A study in the Journal of Analytical Toxicology compared equivalent cutoff threshold levels
in blood versus oral fluid and found that each drug class has varying degrees of differences in the
ng/mL level found in blood versus the ng/mL level found in oral fluid.
versus oral fluid. Each drug class has varying degrees of differences in the ng/mL level found in blood
For example, 1 ng/mL of THC in the blood would be equivalent to approximately 44 ng/mL in oral
versus the ng/mL level found in oral fluid.
fluid (Gjerde, Langel, Favretto, & Verstraete, 2014).
For example, 1 ng/mL of THC in the blood would be equivalent to approximately 44 ng/mL in oral fluid
(Gjerde, Langel, Favretto, & Verstraete, 2014).
Cocaine 10 190
Methamphetamine 20 630
Roadside Steps
Since 2001, the Michigan Commission on Law Enforcement Standards (MCOLES) has required all police
officers completing a basic police academy training program to receive Standardized Field Sobriety Test
(SFST) instruction. The DWI Detection and SFST training curriculum prepares police officers and other
qualified persons to conduct the SFSTs for use in driving while impaired investigations (National Highway
Traffic Safety Administration, 2018).
A DRE receives additional, highly specialized training to assist in identifying drivers under the influence of
drugs other than, or in addition to, alcohol (International Association of Chiefs of Police [IACP], n.d.). The
DRE protocol is a standardized and systematic method of examining a DUID suspect to determine the
following: (1) whether or not the suspect is impaired; if so, (2) whether the impairment relates to drugs or
a medical condition; and if drugs, (3) what category or combination of categories of drugs are the likely
cause of the impairment. The process is systematic because it is based on a complete set of observable
signs and symptoms that are known to be reliable indicators of drug impairment (IACP, n.d.).
There are a number of ways in which a DRE participating in the Oral Fluid Roadside Analysis Pilot
Program might encounter a suspected drug-impaired driver. The contact may be the result of a traffic
stop, a response to a dispatched call to check on a person/vehicle, a response to the scene of a traffic
crash, or a request by another police officer to assist at a scene where a suspected drug-impaired driver
is present. Impairment can be assessed through a variety of observations that precede the DRE process:
• Driving behaviors. Examples include: failure to maintain lane of travel, disregarding traffic control
devices, driving with headlights off, weaving/drifting within and across lanes, excessively wide
turns,
ORAL FLUID followingANALYSIS
ROADSIDE too closely,
PILOTexcessive
PROGRAM speed, speed significantly
· FEBRUARY 2019 slower than posted limits, etc. 7
• Driver behavior: difficulty finding license, slurred speech, bloodshot glassy eyes, swaying,
ROADSIDE USE
Since 2001, the Michigan Commission on Law Enforcement Standards (MCOLES) has required all
police officers completing a basic police academy training program to receive Standardized Field
Sobriety Test (SFST) instruction. The SFST training curriculum prepares police officers and other
qualified persons to conduct the SFSTs for use in driving while impaired investigations (National
Highway Traffic Safety Administration, 2018).
A DRE receives additional, highly specialized training to assist in identifying drivers under the
influence of drugs other than, or in addition to, alcohol (International Association of Chiefs of
Police [IACP], n.d.). The DRE protocol is a standardized and systematic method of examining a
suspected drug-impaired driver to determine the following: (1) whether or not the suspect is
impaired; if so, (2) whether the impairment relates to drugs or a medical condition; and if drugs,
(3) what category or combination of categories of drugs are the likely cause of the impairment.
The process is systematic because it is based on a complete set of observable signs and symptoms
that are known to be reliable indicators of drug impairment (IACP, n.d.).
There are a number of ways in which a DRE participating in the Oral Fluid Roadside Analysis Pilot
Program might encounter a suspected drug-impaired driver. The contact may be the result of a
traffic stop, a response to a dispatched call to check on a person/vehicle, a response to the scene
of a traffic crash, or a request by another police officer to assist at a scene where a suspected
drug-impaired driver is present. Impairment can be assessed through a variety of observations
that precede the DRE process:
If drug impairment is suspected, the DRE may ask the driver to provide two oral fluid
samples. With driver agreement, the first sample will be collected for the Alere DDS2 oral fluid
test instrument. The DRE will insert a new sterile test cartridge into the test instrument. The
instrument will detect the test cartridge and verify the cartridge as valid. The DRE will then remove
the oral fluid collection device from the packaging by the handle. The DRE, or the driver, will then
actively swab the device inside the mouth, around the gums, tongue, and inside the cheek, until
the adequacy indicator on the collection device turns blue. Once enough oral fluid is obtained, the
DRE will then insert the collection device into the Alere DDS2 oral fluid test instrument.
The Alere DDS2 will then analyze the results of the sample. The device will display “test in
progress,” along with a countdown timer. Results of the test will be displayed in approximately
five minutes.
After a test has been administered and analysis by the instrument completed, the instrument will
display either positive, negative, or invalid for each of the listed drug classes.
A positive test result indicates the presence of the drug in the driver’s oral fluid in an amount that
exceeds the cutoff level. It does not indicate a level of impairment.
If the oral fluid results are below the cutoff level, the instrument will display a negative reading.
A negative test result does not confirm the absence of drugs in the oral fluid, only that the
specified level of a drug, or drugs, in a driver’s oral fluid were below the threshold cutoff level
(Alere Toxicology, 2015). A negative result may also be obtained if there is an intoxicating
substance in the driver’s system that is not part of the drug screening panel. Therefore, a negative
reading does not preclude the driver from being impaired by another intoxicating substance that
is not included on the drug screening panel.
The oral fluid test instrument may display an “invalid” reading for a specific drug category or
categories. An invalid reading may be due to an insufficient volume of oral fluid within the test
cartridge. A lack of oral fluid would cause the instrument to not properly read a category(s) of
drug, resulting in an invalid result (Alere Toxicology, 2016). An invalid result in one or more drug
categories does not negate positive and/or negative readings in other drug categories.
The second sample, considered a voluntary sample, is collected using the Quantisal® oral fluid
collection device. The DRE will instruct the driver to remove the collector from the package then
position the collector under the tongue then close his/her mouth. The driver will be instructed
not to chew on the pad or talk until the indicator turns blue, or 10 minutes has lapsed. The DRE
will then insert the collector into the Quantisal transport tube and securely replace the cap for
transport. The DRE will complete the Quantisal paperwork and send the sample to the selected
independent laboratory, Forensic Fluids Laboratories (FFL).
FFL was selected for this pilot as the accredited independent laboratory, used for confirmation
testing of the second oral fluid sample to ensure the accuracy and reliability of the Alere DDS2 oral
fluid test instrument. FFL tests for the six drug class panels: amphetamines, methamphetamines,
opiates, cocaine, benzodiazepines, and cannabinoids, consistent with the selected oral fluid test
instrument. FFL provides for a turn-around time of 24 hours or less.
The counties selected for the Oral Fluid Roadside Analysis Pilot Program were chosen based on
the number of serious injury and fatal traffic crashes involving impaired driving, trained DRE and
DRE prosecutors in the county, their knowledge of the program and willingness to participate in
the pilot, and to reflect Michigan’s highly varied population density.
Impaired
Impaired
DRE Driving
Counties DREs Driving
Prosecutor Traffic
Arrests
Crashes
Berrien 7 1 761 177
Berrien County Sheriff’s Office
Lincoln Township Police Department
Michigan State Police, Niles Post
Delta 3 0 194
Escanaba Department of Public Safety 30
Michigan State Police, Iron Mountain, and
Gladstone posts
MSP (2016)
The MSP created policies and procedures regarding the Oral Fluid Roadside Analysis Pilot Program. In
addition, a Memorandum of Agreement (MOA) was executed by the MSP and partnering agencies to
ensure adherence to program policies and procedures.
Prior• to participation
History of theinOral Fluid Roadside
the program, DREs Analysis
attendedPilot Program
a one-day training session to include:
• Review of Public Acts 242 and 243 of 2016
• Proper Utilization of the Alere DDS2 Oral Fluid Test Instrument
• Forensic Fluids Independent Laboratory—collection of voluntary oral fluid test sample
ORAL• FLUID
Reporting
ROADSIDE Requirements and Utilizing
ANALYSIS PILOT PROGRAM Proper Forms 2019
· FEBRUARY 10
Consistent with instructions outlined in the MOA, DREs were expected to follow MSP policies when
PILOT PROGRAM POLICIES
The MSP created policies and procedures regarding the Oral Fluid Roadside Analysis Pilot
Program. In addition, a Memorandum of Agreement (MOA) was executed by the MSP and
partnering agencies to ensure adherence to program policies and procedures.
Prior to participation in the program, DREs attended a one-day training session to include:
Consistent with instructions outlined in the MOA, DREs were expected to follow MSP policies when
investigating operating under the influence of drugs investigations.
92stops
DRE initiated traffic oraland
fluid roadside
impaired tests
driving were conducted
investigation using the
results, including Alere
traffic DDS2 test instrum
crashes,
occurring betweenrefusal
November 8, 2017 –
to participate.November 8, 2018, are included in the pilot program results.
92 oral fluid roadside tests were conducted using the Alere DDS2 test instrument at the roadside,
with one refusal to participate.
23
52 3
12
62 second voluntary oral fluid tests were collected using the Quantisal® oral fl
theoral
62 second voluntary balance of instances,
fluid tests 30, using
were collected eitherthe
being refused
Quantisal® orfluid
oral not collection
offered. device
with the balance of instances, 30, either being refused or not offered.
As a result of DRE observed driver behavior, and SFSTs, 89 drivers were arre
program. driver
As a result of DRE-observed Of those, positive
behavior oral fluid
and SFSTs, roadside
89 drivers were test results
arrested were
during thereported
pilot for 8
program. Of those, positive oral fluid roadside test results were reported for 83 drivers.
Of the 89 drivers arrested, 79 consented to an evidentiary blood test. Addition
Of the 89 drivers arrested, 79 consented
were obtained. Two to an evidentiary
drivers blood test.
were arrested Additionally,
without eight search
participating in the blood te
warrants were obtained. Two drivers were arrested
charged with marihuana possession. without participating in the blood test: one
fled and one was charged with marijuana possession.
Negative oral fluid roadside test results in all drug categories were recorded in
Negative oral fluid roadside test results in all drug categories were recorded in four instances
drivers were released.
where drivers were released.
70
Number of Tests
60
50
40
30
20
10
0
Amphetamine Benzodiazepine Cocaine Methamphetamine Opiates Cannabis (∆⁹ THC)
Resultsofofthe
Results theoral
oralfluid
fluidroadside
roadsidetests
testsutilizing
utilizingthe
theAlere
AlereDDS2
DDS2 instrument
instrument areare detailed
detailed in in
thethe above cha
Of the 92 oral fluid roadside tests conducted, 21 returned positive results for the
above chart. Of the 92 oral fluid roadside tests conducted, 21 returned positive results for thepresence of two or mo
drugs. Eight tests provided negative results for all six drug categories. Six negative
presence of two or more drugs. Eight tests provided negative results for all six drug categories. test results were
further
Six validated
negative by either
test results wereForensic
further Fluids’
validatedindependent
by either FFL labindependent
results, MSPlab
forensic
results,Lab
MSPresults, or both,
forensic
showing negative results as well.
lab results, or both, showing negative results as well.
Amphetamines
80
70
Amphetamines
80
60
Number of Tests
70
50
60
Number of Tests
40
50
30
40
20
30
10
20
0
10 Roadside OF Independent Lab Blood
0 PosiOve NegaOve Invalid Not Performed
S Roadside OF Independent Lab Blood
PosiOve
Benzodiazepines
NegaOve Invalid
Not Performed
S
90
80
Benzodiazepines
90
70
Number of Tests
80
60
70
50
Number of Tests
60
40
50
30
40
20
30
10
200
10 Roadside OF Independent Lab Blood
0 PosiOve NegaOve Invalid Not Performed
S Roadside OF Independent Lab Blood
PosiOve
Cannabis
NegaOve
(∆⁹ THC)
Invalid Not Performed
S
80
Cannabis (∆⁹ THC)
70
80
60
of Tests
RESULTS 30
FROM THE ORAL FLUID
20
ROADSIDE10 ANALYSIS PILOT PROGRAM
0
Roadside OF Independent Lab Blood
50
40
30
20
10
0
Roadside OF Independent Lab Blood
Cocaine
90
80
70
!
11
Number of Tests
60
50
40
30
20
10
0
Roadside OF Independent Lab Blood
Opiates
90
80
70
ber of Tests
60
ORAL FLUID ROADSIDE ANALYSIS PILOT PROGRAM · FEBRUARY 2019 15
50
40
80
Number of
50
70
Number of Tests
40
60
RESULTS FROM THE ORAL FLUID 30
50
20
ROADSIDE ANALYSIS PILOT PROGRAM 40
10
30
0
20 Roadside OF Independent Lab Blood
10
S 0 PosiOve NegaOve Invalid Not Performed
Roadside OF Independent Lab Blood
Opiates
S PosiOve NegaOve Invalid Not Performed
90
80 Opiates
70
Number of Tests
90
60
80
50
70
Number of Tests
40
60
30
50
20
40
10
30
0
20 Roadside OF Independent Lab Blood
10
S 0 PosiOve NegaOve Invalid Not Performed
Roadside OF Independent Lab Blood
Methamphetamine
S 90 PosiOve NegaOve Invalid Not Performed
80 Methamphetamine
70
90
Number of Tests
60
80
50
70
Number of Tests
40
60
30
50
20
40
10
30
0
20 Roadside OF Independent Lab Blood
10
S 0 PosiOve NegaOve Invalid Not Performed
Roadside OF Independent Lab Blood
!
12
ORAL FLUID ROADSIDE ANALYSIS PILOT PROGRAM · FEBRUARY 2019 16
!
12
RESULTS FROM THE ORAL FLUID
ROADSIDE ANALYSIS PILOT PROGRAM
When comparing test data from the oral fluid tests (roadside and voluntary) and blood tests,
several differences are noted. These differences, depicted in the above charts, can be attributed
to the variables present in this pilot project, including: number of samples in each test category,
medium tested, time from sample collection to testing, instrument sensitivity (threshold cut-off
levels), and testing procedures.
In this pilot, not every driver provided a sample for testing in all three subgroups (roadside,
voluntary, blood). Both oral fluid and blood were tested for the presence of predetermined drug
classes. However, there is no direct numeric correlation between the results of an oral fluid test
and blood test, i.e. 1 ng/mL in oral fluid does not equate to 1 ng/mL in blood. The oral fluid test(s)
were collected in close proximity to when the driver was operating the vehicle. Conversely, the
collection of the blood sample could be hours after the initial police contact and the subsequent
testing could be several weeks after. This time lapse could impact testing results as drugs
breakdown into metabolites while in the bloodstream. Blood samples were tested for the
presence of drug metabolites; oral fluid samples were not tested for metabolites.
The Alere DDS2 roadside oral fluid test instrument is a screening instrument, which gives a
positive or negative test result, rather than a quantitative result (specific nanogram level). The
Alere DDS2 also has specified threshold cut-off levels which are set by the manufacturer for each
tested drug class. With one exception (Benzodiazepines), cut-off threshold levels are higher for
the roadside test than the voluntary test. In some instances, the cutoff levels are significantly
higher. Consequently, the Alere DDS2 roadside oral fluid test instrument may produce a negative
result in a drug category while the voluntary test may indicate a positive result.
The presence of a metabolite is considered confirmation of the parent drug. Noting the above
variables, 88 of the 92 oral fluid roadside test results were confirmed by the independent
laboratory and/or evidentiary blood test results.
Statistical analyses was performed by Michigan State University statistician, Dr. Dhruv Sharma,
Ph.D. The results of this analysis are attached as an appendix to this report.
The specific procedures and instrumentation used to perform the voluntary oral fluid test
analyses, and the blood analyses, are also attached as appendixes to this report.
Sixty-two traffic stops resulted in an arrest for operating under the influence of a controlled
substance in violation of Section 625 as a result of roadside drug testing by a certified DRE.
Twenty-seven additional arrests were made as a result of impaired driving investigations to
include traffic crashes.
As of December 20, 2018, 38 drivers have been convicted of 47 charges, noting that individuals
can be convicted in more than one category.
Forty-nine cases pend a final court disposition. One case was dismissed and one case was
not prosecuted.
RECOMMENDATION
Traffic enforcement is critical to improving traffic safety and keeping Michigan motorists safe on our
roadways. Improving traffic safety remains one of the MSP’s highest priorities. Identifying drug-impaired
drivers, a priority of traffic enforcement efforts, presents unique challenges not inherent to identifying
those that are alcohol impaired. Not all police officers in Michigan have received specialized training
enabling them to identify and properly investigate drug-impaired drivers. In addition to seeking such
specialized training, making a roadside oral fluid analysis instrument available to a greater number of
police officers warrants additional consideration.
Pursuant to Public Act 243 of 2016, it is the recommendation of the Oral Fluid Roadside Analysis Pilot
Program Committee that the pilot program be expanded for one year to include all DREs in the state of
Michigan.
Expansion of this pilot program will allow a greater number of police departments in Michigan to take
advantage of the expertise of participating DREs to assist with traffic stops and drug-impaired driving
investigations. Arresting drug-impaired drivers can be expected to mitigate serious injury and fatal traffic
crashes throughout Michigan.
ORAL FLUID ROADSIDE ANALYSIS PILOT PROGRAM · FEBRUARY 2019 18
All DREs in the state of Michigan will be eligible to participate in the expanded pilot program, subject to a
RECOMMENDATION
Traffic enforcement is critical to improving traffic safety and keeping Michigan motorists safe on our
roadways. Improving traffic safety remains one of the MSP’s highest priorities. Identifying drug-impaired
drivers, a priority of traffic enforcement efforts, presents unique challenges not inherent to identifying
those that are alcohol impaired. Not all police officers in Michigan have received specialized training
enabling them to identify and properly investigate drug-impaired drivers. In addition to seeking such
specialized training, making a roadside oral fluid analysis instrument available to a greater number of
police officers warrants further consideration.
Pursuant to Public Act 243 of 2016, it is the recommendation of the Oral Fluid Roadside Analysis
Pilot Program Committee that the pilot program be expanded for one year to include all DREs in the
state of Michigan.
Expansion of this pilot program will allow a greater number of police departments in Michigan to take
advantage of the expertise of participating DREs to assist with traffic stops and drug-impaired driving
investigations. Arresting drug-impaired drivers can be expected to mitigate serious injury and fatal traffic
crashes throughout Michigan.
All DREs in the state of Michigan will be eligible to participate in the expanded pilot program, subject to
a properly executed MOA. Participating DREs will be issued an oral fluid test instrument and available to
assist when called to respond to a traffic stop or impaired driving investigation. At the time of this report,
there were 137 DREs in 46 counties throughout Michigan. A DRE school in January 2019 is expected to
add up to 22 DREs, resulting in a total of up to 159 DREs throughout the state.
The MSP will continue to be responsible for the functions of the Oral Fluid Roadside Analysis Pilot
Program, including, but not limited to; handling all policies and procedures, equipment and supplies
management, capturing and analyzing data obtained from the extended pilot program, and program
training for participating DREs.
The recently completed Oral Fluid Roadside Analysis Pilot Program provided valuable data on the overall
performance and utility of the Alere DDS2 device. However, the data set for certain drug classes was not
of a suitable sample size to achieve high confidence levels in the obtained result. The additional data
expected to be obtained from an expanded pilot program may improve the overall confidence in the
accuracy, sensitivity, specificity, positive predictive values, and negative predictive values of all six drug
categories of the Alere DDS2 device. If analysis of this additional data set yields a high level of confidence,
and the utility of the device is favorable in the opinion of the participating officers, the results of the
pilot may support revision of the Michigan Vehicle Code to permit preliminary oral fluid analysis for
the detection of certain drug categories. By conducting the much larger extended Oral Fluid Roadside
Analysis Pilot Program, the state of Michigan may also provide invaluable information to other states.
In December 2018, the Michigan Legislature agreed to support the ongoing funding of the oral fluid pilot
and the expansion of the pilot program to additional interested, qualified counties around the state.
An appropriation of $626,000 for the extension of the Oral Fluid Roadside Analysis Pilot Program was
included in the supplemental funding bill that became Public Act 618 of 2018.
In the coming months, the MSP will continue its work to acquire the necessary equipment and develop
specific policies, procedures, and data collection requirements to support the necessary analyses of the
expanded pilot program.
The Oral Fluid Roadside Analysis Pilot Program Committee would like to thank the Michigan
Legislature for the continued support, dedication, and appropriations for the Oral Fluid Roadside
Analysis Pilot Program.
The Committee would also like to thank the following people, companies, and law enforcement
agencies for their contributions to the success of the Oral Fluid Roadside Analysis Pilot Program.
A true positive (TP) result is one where the device detects the presence of a drug when the
A true posi;ve (TP) result is one where the device detects the presence of a drug when the presence of
presence of the drug is confirmed by the gold standard. A true negative (TN) result is one where
the drug is confirmed by the gold standard. A true nega;ve (TN) result is one where the drug is absent in
the drug is absent in device testing and this absence is confirmed by the gold standard. A false
device tes;ng and this absence is confirmed by the gold standard. A false posi;ve (FP) result is one
positive (FP) result is one where the device detects the presence of a drug when it is in fact absent.
where the device detects the presence of a drug when it is in fact absent. A false nega;ve (FN) result is
A false negative (FN) result is one there the device does not detect the drug while it is detected by
one there the device does not detect the drug while it is detected by the gold standard. The
the gold standard. The performance of the device testing approaches are assessed using the five
performance of the device tes;ng approaches are assessed using the five measures below.
measures on the next page.
1. Sensi;vity = TP/(TP+FN). Sensi;vity measures the number of true posi;ves as a percentage of all
posi;ves.
Inference for these percentages is reported using sample estimates of the measures and their
95% confidence interval using binomial proportions, with the 95% confidence interval calculated
using the Agresti Approximation [Citation: Agresti, A., & Coull, B. (1998). Approximate Is Better
than “Exact” for Interval Estimation of Binomial Proportions. The American Statistician, 52(2),
119-126. doi:10.2307/2685469]. To explain what is meant by 95% confidence interval, it should be
noted that the key goal in inferential statistics is to draw inferences about unknown population
parameters based on sample statistics. This is done by selecting a representative sample (e.g., pilot
drug testing data) from the target population and use sample statistics as estimates (the point
estimate and confidence interval (CI) estimate) of the unknown parameter. In this case, the sample
percentages are used (e.g., sample accuracy) to draw inference about the population percentages
(e.g., population accuracy). A 95% confidence interval means that if 100 different samples were
taken and compute a 95% confidence interval for each sample, then approximately 95 of the 100
confidence intervals will contain the true population value. In practice, however, one random
sample is selected and generate one confidence interval, which may or may not contain the true
mean. The observed interval may over or underestimate the true value. Consequently, the 95%
CI is the likely range of the true, unknown parameter. The confidence interval does not reflect the
variability in the unknown parameter. Rather, it reflects the amount of random error in the sample
and provides a range of values that are likely to include the unknown parameter.
RESULTS:
Results for the six drugs tested will be discussed in alphabetic order; Amphetamines,
Benzodiazepines, Cocaine, Methamphetamines, Opiates and THC. In addition, for Cocaine,
Methamphetamines, and THC, additional results for the findings of the delayed blood testing
results will be presented. Please see Appendix Tables A1-A6 for descriptive statistics.
1. AMPHETAMINES:
The overall performance of the test instrument is good, apart from the positive on-site test results,
which showed a presence of amphetamines in six samples that was not present in the blood. This
resulted in a lower than expected PPV (estimate of 62.50%, 95% CI of 38.60% to 81.50%), although
this result is improved when comparing the voluntary test results with the blood test results,
where there were no FP or FN values, resulting in 100% performance measures. Performance
results are presented in the Appendix in table form (please see Table A7).
2. BENZODIAZEPINES:
The overall performance of the test instrument is good, apart from the negative on-site test
results, which failed to show a presence of benzodiazepines in eight samples that was present in
the blood. This resulted in a lower than expected sensitivity (estimate of 50.00%, 95% CI of 28.00%
to 72.00%), which is not improved when comparing the voluntary test results with the blood test
results (estimate of 33.30%, 95% CI of 9.70% to 70.00%). Performance results are presented in the
Appendix in table form (please see Table A8).
3. COCAINE:
The overall performance of the test instrument is good, with good results in the immediate
sample, apart from the positive on-site test results, which showed a presence of cocaine in
two samples that was not present in the blood. This resulted in a lower than expected PPV
(estimate of 71.40%, 95% CI of 35.90% to 91.80%). These results continue with a higher number
of negative blood results (total seven samples) while having higher voluntary results with lower
than expected PPV (estimate of 22.20%, 95% CI of 6.30% to 54.70%). When looking at the delayed
sample, due to the one sample positive change in the blood testing result in the delayed sample,
the overall results are improved, calling attention the need for more efficient blood sample
collection and testing. Performance results are presented in the Appendix in table form
(please see Tables A9-A10).
4. METHAMPHETAMINES:
The overall performance of the test instrument is good, with good results in the immediate
sample, apart from the positive on-site test results, which showed a presence of
methamphetamines in one sample that was not present in the blood. This resulted in a lower than
expected PPV (estimate of 66.70%, 95% CI of 20.80% to 98.30%). Please note, we caution that this
measure was calculated from a very small sample of three. When looking at the delayed sample,
due to the one sample positive change in the blood testing result in the delayed sample (the only
change), the overall results are vastly improved, with no FP or FN readings, calling attention the
need for more efficient blood sample collection and testing. Performance results are presented in
the Appendix in table form (please see Tables A11-A12).
5. OPIATES:
The overall performance of the test instrument is good with only one FN reading in both the on-
site and voluntary test readings while compared to the blood test readings. Performance results
are presented in the Appendix in table form (please see Table A13).
6. THC:
The overall performance of the test instrument is good, with good results in the immediate
sample, apart from the positive on-site test results, which showed a presence of THC in 11
samples that were not present in the blood. This resulted in a lower than expected specificity
(estimate of 50.00%, 95% CI of 30.70% to 69.30%). When looking at the delayed sample, due to the
6 samples positive change in the blood testing result in the delayed sample, the overall results are
vastly improved (specificity improves (estimate of 68.80%, 95% CI of 44.40% to 85.80%)), calling
attention the need for more efficient blood sample collection and testing. Performance results are
presented in the Appendix in table form (please see Tables A14-A15).
DISCUSSION:
In this analysis, the findings have summarized for the pilot drug testing data, both immediate
and delayed. Overall, the device has good performance properties, which are further improved
when the blood testing results come from the ‘delayed’ dataset, calling into attention the need
for improvements in the blood collection and testing approach. Although the pilot study yields
good results for the utilization of the device, caution is urged due to the small number of samples
collected in this pilot study. Some issues with a small sample size include the inflation of the negative
effects caused by a FP or FN reading in even one sample. Further data collection would be needed to
be more confident in the findings from the perspective of statistical analysis and inference.
In this analysis, the findings have summarized for the pilot drug tes;ng data, both immediate and
Notes:
NOTES:
Dhruv B. Sharma, Ph.D., who is a statistical consultant and Senior Statistician at the Center
Dhruv B. Sharma, Ph.D., who is a sta;s;cal consultant and Senior Sta;s;cian at the Center for Sta;s;cal
for Statistical Training and Consulting (CSTAT) at Michigan State University, East Lansing,
Training and Consul;ng (CSTAT) at Michigan State University, East Lansing, Michigan, conducted this
Michigan, conducted this analysis. All analyses for this report are reproducible and all analysis
analysis. All analyses for this report are reproducible and all analysis was implemented using R sta;s;cal
wassoqware [Cita;on: R Core Team (2018). R: A language and environment for sta;s;cal compu;ng. R
implemented using R statistical software [Citation: R Core Team (2018). R: A language and
environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria.
Founda;on for Sta;s;cal Compu;ng, Vienna, Austria. URL heps://www.R-project.org/].
URL https://www.R-project.org/].
Missing 30 32.6
Y | 1 5
4
Total 92 100 100
Blood Test Results (Immediate)
Frequency Percentage Valid %
Nega=ve 74 80.4 86.1
Posi=ve 12 13.0 14.0
Missing 6 6.5
Total 92 100 100
Y | 1 5
5
Missing 6 6.5
Total 92 100 100
Blood Test Results (Delayed)
Frequency Percentage Valid %
Nega=ve 17 18.5 19.8
Posi=ve 69 75.0 80.2
Missing 6 6.5
Total 92 100.0 100.0
MICHIGAN STATE
Posi=ve POLICE ORAL
69 FLUID
75.0 PILOT
80.2 STUDY
ANALYSES BYMissing
DHRUV
Total
B. SHARMA,
6
92
Ph.D. 6.5
100.0 100.0
MICHIGAN NPV
STATE POLICE100.00%
ORAL FLUID
92.70% PILOT
100.00% STUDY
ANALYSES BYAccuracy
DHRUV B. SHARMA, 100.00%
Ph.D. 93.60%
Footnote: CL is the 95% Confidence Limit calculated using the Agres; Approxima;on.
100.00%
On-site Posi;ve 2 2
Nega;ve 0 57
Performance Sta=s=cs
Es=mate Lower CL Upper CL
Sensi=vity 100.00% 34.20% 100.00%
Specificity 96.60% 88.50% 99.10%
PPV 50.00% 15.00% 85.00%
NPV 100.00% 93.70% 100.00%
Accuracy 96.70% 88.80% 99.10%
Voluntary vs. Blood Cross Table
On-site Posi;ve 3 1
Nega;ve 6 50
Performance Sta=s=cs
Es=mate Lower CL Upper CL
Sensi=vity 33.30% 12.10% 64.60%
Specificity 98.00% 89.70% 99.90%
PPV 75.00% 30.10% 98.70%
NPV 89.30% 78.50% 95.00%
Accuracy 88.30% 77.80% 94.20%
Voluntary vs. Blood Cross Table
On-site Posi;ve 6 1
Nega;ve 0 76
Performance Sta=s=cs
Es=mate Lower CL Upper CL
MICHIGAN STATE
NPV POLICE100.00%
ORAL FLUID
92.40% PILOT
100.00% STUDY
ANALYSES BYAccuracy
DHRUV B. SHARMA,
89.30%
Ph.D.
78.50% 95.00%
Footnote: CL is the 95% Confidence Limit calculated using the Agres; Approxima;on.
On-site Posi;ve 1 1
Nega;ve 0 54
Performance Sta=s=cs
MSP Oral Fluid Pilot Study Es=mate Lower CL Upper CL
Dhruv B. Sharma, Ph.D.
Sensi=vity 100.00% 5.10% 100.00%
Specificity 98.20% 90.40% 99.90%
PPV 50.00% 2.60% Y14 | 1 5
97.40%
NPV 100.00% 93.40% 100.00%
Accuracy 98.20% 90.60% 99.90%
Voluntary vs. Blood Cross Table
Cross Table Blood
Results Posi;ve Nega;ve
Voluntary Posi;ve 3 0
Nega;ve 0 53
Performance Sta=s=cs
Es=mate Lower CL Upper CL
Sensi=vity 100.00% 43.90% 100.00%
Specificity 100.00% 93.20% 100.00%
PPV 100.00% 43.90% 100.00%
NPV 100.00% 93.20% 100.00%
Accuracy 100.00% 93.60% 100.00%
Footnote: CL is the 95% Confidence Limit calculated using the Agres; Approxima;on.
On-site Posi;ve 3 0
Nega;ve 0 74
Performance Sta=s=cs
Es=mate Lower CL Upper CL
MICHIGAN NPV
STATE POLICE 98.10%
ORAL FLUID
90.10%
PILOT
99.90%
STUDY
Accuracy 98.20% 90.60% 99.90%
ANALYSES BY DHRUV B. SHARMA, Ph.D.
Footnote: CL is the 95% Confidence Limit calculated using the Agres; Approxima;on.
MICHIGAN STATE
NPV POLICE98.10%
ORAL FLUID
89.90% PILOT
99.90% STUDY
ANALYSES BYAccuracy
DHRUV B. SHARMA,
98.20%
Ph.D.
90.60% 99.90%
Footnote: CL is the 95% Confidence Limit calculated using the Agres; Approxima;on.
MSP Oral Fluid Pilot Study On-site vs. Blood Cross Table
Dhruv B. Sharma, Ph.D.
Cross Table Blood
Results Posi;ve Nega;ve
On-site Posi;ve 62 Y17 | 1
11 5
Nega;ve 1 11
Performance Sta=s=cs
On-site Posi;ve 68 5
Nega;ve 1 11
Performance Sta=s=cs
Es=mate Lower CL Upper CL
Voluntary Posi;ve 45 3
Nega;ve 0 8
Performance Sta=s=cs
Es=mate Lower CL Upper CL
Blood samples analyzed by the Michigan State Police toxicology discipline were collected in 10-mL
grey-top vacutainer tubes containing 20 mg of potassium oxalate and 100 mg of sodium fluoride.
Blood collection tubes are included in biological specimen collection kits which are distributed to
all law enforcement agencies in Michigan. Samples are evidentiary and collected as part of routine
investigation into OWI/OUID.
All samples were initially analyzed by headspace gas chromatography with flame ionization
detector (GCHS-FID) for volatiles. Analysis was conducted on two Thermo Trace Ultra Gas
Chromatographs. One gas chromatograph contains a Rtx-BAC Plus 1 column measuring 30 m x
0.53 mm ID x 3 µm. The other gas chromatograph contains a Rtx-BAC Plus 2 column measuring 30
m x 0.53 mm ID x 1 µm.
Samples that require drug analysis undergo preliminary drug screening by liquid chromatography
tandem mass spectrometry (LC-MS/MS). Samples are analyzed on a SCIEX QTRAP 4500 containing
an Agilent poroshell 120 column, EC-C18, 3.0 mm x 50 mm x 2.7 µm. Samples were screened for
fifty-five drugs and sent on for confirmation if there were any positives. Protocol dictates that
samples in which ethanol is ≥ 0.10 g/dL do not get analyzed for drugs, however that protocol was
suspended for samples that were collected as part of this pilot program.
All instrument operating parameters were optimized, and method validation was conducted
utilizing the guidelines from the Scientific Working Group for Forensic Toxicology (SWGTOX)
Standard Practices for Method Validation in Forensic Toxicology.
• Samples are received at the lab sealed 3 times (sample tube sealed, clear
specimen bag sealed, UPS bag sealed). Paperwork signed and dated by both the
donor and observer.
• A Specimen Processing person checks chain-of-custody and logs sample into
Laboratory Information Management System (LIMS).
• The specimen goes into the Screening Lab where FDA approved immunoassay
tests are performed (ELISA, enzyme-linked immunoassay serum assay). If the
sample is negative a lab report is generated. If the samples “screens” positive
for any of the drugs or drug classes (Amphetamine, Methamphetamine, THC/
Marijuana, Cocaine, Opiates, Benzodiazepines, Oxycodone, etc.), it is considered
“presumptive” and the sample goes to the Confirmation Lab.
• The Confirmation Lab uses LCMSMS (Liquid Chromatography Tandem Mass
Spectrometry) to positively identify what drug(s) is in the sample and how much
drug is there. LCMSMS is recognized as the most scientifically
accurate instrument currently available. Mass Spectrometry positively identifies
drugs, thus eliminating “false positives” that might occur in the Screening step
above. A positive “confirmed” lab report is then generated.
• FFL is CLIA (Clinical Laboratory Improvement Amendments) certified Lab.
CLIA is overseen by the CMS (Center for Medicare & Medicaid Services). CLIA
certification assures that FFL follows Standard Operating Procedures and has
an excellent Quality Control program. FFL also has to subscribe to
Proficiency or blind-sample testing on a quarterly basis, and pass
these tests with a grade of 85%. FFL normally get 100% on these tests. FFL
currently can identify over 150 drugs.
• Due to the accuracy of our internal chain-of-custody for each sample and our
scientific methods, our test results are admissible in court and have
been accepted in over 10 states. FFL also has two court qualified Toxicologists
with another Toxicologist “in-training”.
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