E. Cost

F. Legality

a

Location
H. Storage

1. Calibration

J. Reliability

Initial cost for the typical portable unit is between $500.00 and $800.00. For each
test conducted, a disposable mouthpiece costing about $0.35 is required. Each
instrument can be used hundreds of times, making a single test very expensive, but
many tests very inexpensive.

In some states this method has evidential status equivalent to the blood alcohol test,
when calibration, operator competence and data archival are assured.Certain of
these portable devices come with printers and/or data storage capability for data
archival. Such evidence has been used io show cause for further analytical testing.

This type of screening device can be used at any location.

This type of instrument requires no special storage, and is ready for use continually if
the batteries are charged.

Demonstration of calibration is required about every six months to maintain certifica-
tion. Actual calibration is rarely necessary, but can be done in the field with an ethanol
breath simulator.

This type of instrument is very reliable.

TIN OXIDE CERAMIC (TAGUCHI) SENSOR

A. Sensitivity

B. Specificity
C. Precision

D. Operator

E. Cost

F. Legality

G. Location
H. Storage

I. Calibration

J. Reliability

Vv. CHEMICAL:
A. Sensitivity

B. Specificity

The lowest valid quantification achieved by this type of instrumentation is comparable
to the other electronic methods (about 15 mg%) .

Poor: reacts with hydrocarbons and other alcchols.

The coefficient of variance obtained with this type of instrumentation is about + 10
mg%.

Degree not required, one day preliminary training in conduct of test and evaluation
of results/reporting, recurrent yearly seminar is desirable.

Initial cost for the typical portable unit is from about $500.00 to $800.00 each. For
each test, a disposable mouthpiece costing about $0.35 is required. Zach device can be
used hundreds of times, making one test highly expensive, but many tests inexpensive.

The evidential status of this method is not as complete as the other electronic
methods. The lack of specificity renders this evidence more applicable to showing
cause for further analytical testing.

This type of screening instrument can be used at any location.

This type of instrument should require no special storage and be ready for use
continually.

Demonstration of calibration is required about every six months to maintain
certification. Actual calibration is rarely necessary, but can be done in the field with an
ethanol breath simulator.

This instrumentation is generally reliable.

The lowest valid quantification level for a reliable “positive” response is somewhere
between 20 to 40 mg%; this type of test works best at high breath alcohol levels.

Poor: reacts positively with aldehydes, ketones, and other alcohols.


alcohols have been shown in the presence of high
ethanol for the infrared method, and are possible
for enzymatic methods. Lower specificity is also
seen for the portable chemical methods, ali of
which use an oxidant such as potassium dichromate
which reacts with aldehydes, ketones, and other
alcohols. The tin oxide ceramic (Taguchi) elec-
tronic sensor reacts indiscriminately with hydro-
carbons. Table 1 provides a quick reference for
comparisons of specificity.

SENSITIVITY. The minimum quantity of etha-
nc! in vivo that alcoho! detection equipment can
detect accurately varies, although this measure
needs to be as exacting as possible. The application
of alcohol detection equipment in law enforcement
activities requires a minimum quantitative sensi-
tivity of 10 mg% for evidential purposes, as af-
firmed in many States by the statutory approval of
alcohol detection equipment with this level of sen-
sitivity. Methods with less quantitative and/or quali-
tative sensitivity can only be used forensically to
show cause for further analytical testing with more
sensitive methods.

Using the most sensitive blood test techniques,
some analytical laboratories can measure as little as
2 mg% ethanol, although the average sensitivity is
at or near 10 mg%. This is also the average sensi-
tivity level for equipment with infrared and fuel-
cell electronic sensors, and the ‘ikely level for the
portable enzymatic devices, which are new and
remain basically unproven. The electronic tin ox-
ide ceramic sensor sensitivity is in the 10 to 15
mg% range; the minimum detectable resolution of
portable chemical equipmentis in the 20to 40 mz%
Tange and is generally qualitative in nature. Figure
1 displays information on sensitivity.

PRECISION. The amount (coefficient) of varia-
tion in the repeated measurement of a given test
sample with a known percentage defines the preci-
sion of alcoho! detection. In practice, this quality is
generally tied closely to sensitivity, reflecting the
statistical reliability of the alcohol levels obtained.
The coefficient of variation for blood test methods
averages about + 5 mg%; the coefficient of varia-
tion for infrared and fuel-cell electronic methods
approaches + 10 mg% (the level of sensitivity).

ETHANOL DETECTION EFFICACY

Detection efficacy shown in mg%-: higher #’s = less sensitivity

FIGURE 1: ETHANOL DETECTION EFFICACY


APPENDIX I
SUGGESTED ORDER OF COMPLIANCE WITH CRITICAL DOMAINS *
FIXED METHODS

1. Blood test methods
2. Electronic infrared methods

RTABLE ME’ ID:
1. Fuel-cell electronic methods
2. Enzymatic methods

3. Tin oxide ceramin sensor methods
4. Chemical methods

*Order of compliance for boundary domains for portable methods also conforms to this sequence if cost-
per-test is figured on a long-term, many-tests-per-instrament basis. See Appendix IL.

A-1



with a smali cost per test ($0.25 to $0.50) necessary
to pay fordisposable mouthpieces. The unit cost for
the enzymatic test instruments is currently $3.00
per test; the cost per test instrument for the typical
portable chemical instrument is about $2.00, de-
creasing to about $1.15 in quantities of 1000 or
more. Operator costs are assumed to be equivalent
for all portable methods in this analysis.

These costs make the administration of only a
few enzymatic and/or portable chemical tests rela-
tively inexpensive, although these methods can
only be used once per test instrument. Compared to
the portable electronic test methods, the relative
cost escalates rapidly with an increase in the num-
ber of tests conducted. When the number of tests
administered per portable electronic instrument
reaches about 350. the portable electronic methods
achieve the same low cost per test associated with
the portable enzymatic and chemical methods.
Beyond that number, portable electronic methods
gain an ever-increasing cost advantage (Figure 2).

STORAGE. Problems with storage are mainly
relevant to portable instruments. Electronic test
instruments are essentially impervious to almost

apy insult, except extreme temperatures and water,
and they have an indefinite shelf life. Enzymatic
test instruments should also be relatively resistant
to insult except water and chemicals, especially if
stored in the original sealed packaging. However,
puncture of the package makes them suspect, and
they have a specified shelf life. Portable chemical
instruments are hermetically sealed and resistant to
water and chemicals, but they are likely to be
susceptible to ultraviolet (UV) light and extreme
temperatures.

D.O.T. APPROVAL. Specific test instruments
approved to date by the Department of Transporta-
tion are based on the National Highway Traffic
Safety Administration specifications as published
in the Federal Register (1); these specifications
Tequire prospective test instruments to pass a full
range of qualification tests of engineering, con-
struction and performance criteria. A conforming
products list has also been published and recently
updated in the Federal Register (3\. Of all the
portable instruments available, only electronic test
instruments appear on the conforming products

RELATIVE COST IN TOTAL DOLLARS

PORTABLE INSTRUMENTS

FIGURE 2. COST OF PORTABLE ALCOHOL DETECTION TESTS


Electronictin oxide ceramic sensors provideslightly
more variable data on etnanol levels than the other
electronic methods. As is the case for sensitivity,
only qualitative indications of precision are avail-
able for portable chemical detection methods; this
is also the case for portable enzymatic methods.
Figure 1 displays information on precision of alco-
hol detection methods.

BOUNDARY PERFORMANCE DOMAINS

READINESS. The availability of any method to
perform testing upon demand determines whether
the method is continually useful. In general, blood
test and infrared electronic methods are kept in
chronically high states of readiness because of their
fixed locations in certified analytical laboratories.
The fuel-cell and tin oxide ceramic sensor elec-
tronic methods are also ready to use quickly, hav-
ing solid state circuitry and battery powerto provide
short warm-up times. Failure of the batteries can be
aproblem, but some instruments operate on typical
9-volt disposable batteries that can be replaced
quickly and without tools. The enzymatic and por-
table chemical methods are also readily available,
unless they become contaminated in some manner,
which should be rare with minimum care.

LOCATION/PORTABILITY. The issue of port-
ability forms one cf the most important additional
qualifications for selection ofan ethanol testmethod.
Use in FAA facilities or in the aviation environ-
ment precludes the ready availability of a certified
analytical laboratory and/or fixed ethanol testing
facility, making the blood test and infrared elec-
tronic test methods generally untenable. The re-
maining methods are all portable, although there
are differences in weight and size. The electronic
(fuel-cell and tin oxide ceramic sensor) methods
are generally hand-sized and weigh about one
pound; the enzymatic and portable chemical metl.
ods are generally about the size and weight of a
pencil.

CALIBRATION. The assurance of calibration
for alcohol detection equipment determines whether
aspecific set of test data can be used in the prosecu-
tion of a person suspected of using ethanol ille-
gally. Stated recalibration periods are typical for
blood test, infrared, electronic fuel-cell nd tin
oxide ceramic sensorinstrumeats. Instruments used
for blood tests typically require more sophisticated
and timely calibration procedures, because of their
use as general analytical instruments. This con-
trasts with the lesser need for calibration of infrared
and portable electronic devices in which calibra-

tion can generally be accomplished easily in the
field if a dreath alcohol simulator is available. The
calibration of enzymatic and portable chemical
methods is apparently predetermined and hope-
fully unnecessary, since no method for verification
of calibration of these devices is generally avail-
sble.

LEGALITY. The evidential stams of alcohol
detection equipment determines whether ethanol
test data can be used in a court of law for prosecu-
tion of a person suspected of using ethanol ille-
gally. Blood test methods are the only universal
source of evidential data, although several of the
electronic test instruments with data archival fea-
tures have been certified in some states. Among
these, infrared test methods have the best status.
However, these instruments are typically located in
a fixed or mobile certified alcohol testing labora-
tory. Portable electronic methods, such as the fuel
cell and tin oxide sensor devices, are also certified
for evidential purposes in some states. In places
where they do not enjoy evidential status, they can
generally be used to demonstrate cause for further
analytical testing. Portable enzyinatic methods are
currently being tested, but are only certified to
show cause for further testing at this time. Portable
chemical methods, because of their qualitative na-
ture, may never enjoy evidential status.

OPERATOR STATUS. The qualifications to
administer any pasticular ethano! test method vary
widely on educational level, training, and experi-
ence. Blood test methods should only be conducted
by someone who is thoroughly trained to work ina
certified analytical laboratory. Typical qualifica-
tions for this type of operator would include a
Bachelor of Science degree in chemistry or one of
the Niological sciences, a one-week course on the
operation of the specific instrument to be used, and
familiarity with the analytical procedure. The other
test methods would require no specific educational
criteria, but would require at least a one-day train-
ing seminaz on the operation, results, and reporting
procedures associated with administration of the
iest. A yearly recurrent training seminar would be
advisable for all testing methods.

COST. Blood test instruments and the infrared
electronic instruments each cost several thousand
dollars per instrument, making the administration
of literally thousands of tests necessary to justify
the monetary outlay. Similarly, the cost of elec-
tronic fuel-cell and tin oxide ceramic sensor instru-
ments is several hundred dollars per instrument,


instrument compare with those of any other pro-
vides ratios of the relative performance efficacies
of alcohol test instruments.

The prerequisite for this process, of course, is a
thorough identification of the intended purpose and
target environment, as well as a thorough under-
standing of the compliance of alcohol test methods
with the relevant Performance Domains. Without
such an approach, the selection process may fail to
satisfy the necessary requirements and possibly
lead to acquisition of test instruments with limited
value or excessive costs.

Appendix I provides a comparison of fixed and
portable alcool test methods compliance with the
Critical Zerformance Domains. Appendix II pro-
vides a quick reference for comparison of portable
alcohol tests methods compliance with both Criti-
cal and Boundary Performance Domains. Appen-
dix IH provides a complete assessment of both
fixed and portable alcohol test methods compli-
ance.

REFERENCES

1. National Highway Traffic Safety Administration:
Model Specifications for Evidential Breath Test-
ing Devices and Publication of a Conforming
Products List, Federal Register, Vol. 49, No. 242,
48855-48864, December 14, 1984.

2. National Highway Traffic Safety Administration:
Model Specifications for Calibrating Units for
Breath Alcohoi Testers and Publication of a Con-
forming Products List, Federal Register, Vol. 49,
No, 242, 48865-48872, December 14, 1984.

3. National Highway Traffic Safety Administration,
Highway Safety Program: Amendment of Con-
forming Products List of Evidential Breath Testing
Devices, Federal Register, Vol. 55, No. 39, 6865,
February 27, 1990.

4. National Highway Traffic Safety Administration:
The Accuracy of Evidential Breath Testers at Low
BAC’s, DOT/NHTSA Technical Note, DOT HS
807 415, May 1989.

5. Mason, NF & KM Dubowski: “Alcohol, Traffic,
and Chemical Testing in the United States: A
Resume and Some Remaining Problems.” Clini-
cal Chemistry. Vol. 20/2, pp. 126-140, 1974.

6. Cowan, Jr, JM,JR McCutcheon & A Weathermon:
“The Response of the Intoxilyzer 4011AS-A to a
NumberofPossible Interfering Substances,” Jour-
nal of Forensic Sciences, JFSCA, Vol.35, No.4,
pp. 797-812, 1990.

7. Hunt, DJ, IP Williamson, VJ Emerson, MDJ Isaacs,
& JM Jacobs: The Effects of Eiectronic Screening
Devices on the Enforcement of the B-itish Drunk/
Driving Legislation, British Crown. Copyright,
1983.

8. Lestina, DC & AK Lund: Laboratory Evaluation
of Two Passive Alcohol Sensors, Insurance Insti-
tute for Highway Safety, August, 1989.

9. Watts, VA: Comparative Study on Two Breath
Screening Devices, The ALCOSENSOR III and
The ALCOTEST, MesaPolice Depanment Crime
Laboratory, Mesa, AZ, 1985.

10. Fiores, AL:Results of Conformance Testing of
Evidential Breath Alcohol Testing Device, DOT
Transportation Systems Center, 1989.

11.McDonough, DI: Evaluation of the
ALCOSENSOR III Breath Alcohol Tester for
Evidential Use in Idaho, Idaho Department of
Health and Welfare Bureau of Laboratories, 1988.

12. Lion: The Fuel Cell, January 1989.


AD-A240 441
eee

DOT/FAA/AM-91/12

Office of Aviation Medicine
Washington, D.C. 20591

91- 10522
nea

Selection Criteria
for Alcohol
Detection Methods

Garnet A. McLean
Bruce C. Wilcox
Dennis V. Canfield

Civil Aeromedical Institute
Federal Aviation Administration
Oklahoma City, OK 73125

pogo OTIC

BELECTE!
SEP.16 1991,

B

Final Report

This document is available to the public through
the National Technical Information Service,

Springfield, Virginia 22161.

DISTRIBUTION STATEMENT A

Approved for publie release]
Distribution Unlimited

©

U.S. Department
of Transportation

Federal Aviation
Administration

gl 9 12 1992



APPENDIX II

SUMMARY COMPARISON OF ALCOHOL TESTING METHODS
(Possibly significant limitations BOLDED)

FIXED TEST METHODS

1. BLOOD TEST:

A. Sensitivity The lowest valid q_.antification this type of test can achieve is about 10 mg% (O m g/
dl).

B. Specificity | Highly specific for ethanol; uses alcchoi dehydrogenase enzymatic reactions or g3s
chromatographic techniques.

C. Precision The average coefficient of variance is abo + 5 mg%, with sume labs much better than
others.

D. Operator Needs BS degree in science, 1 week preliminary training, 6 months experience and
certification is desirable. Must work in an analytical tab, and receive a recurrent training
seminar yearly.

E. Cost Initial instrumentation cost is about $15,000, with an added cost of a few dollars
per specimen tested to cover supplies. Each instrument can be used thousands of
times, making a single test very expensive, but many tests relatively inexpensive.

F, Tt esality This is the most accepted method to provide evidence in the prosecution of a pers on
suspected of using ethano! illegaily. The analytical laboratory shovld have a well-
documented quality contre] and pre iiciency testing program.

G. Location This type of instrumentation should be in a certified analytical laboratory.

H. Storage This type of instrumentation should not be stored and should be kept operational at all
times.

I. Calibration Calibration is required about every six months to maintain certification.

J. Reliability | This inst mentation is generally reliable.

sts INFRARED ELECTRONIC:

A. Sensitivity The lowest vaiid quantification achieved with this type of instrumentation is equivalent
to the blood test methods (10 mg%).

B. Specificity | Thismethodis generally impervious to false positives by substances other than ethanol.
Only in the presence of large ethanol jevels have imterferences been shown.

Cc. Precision The average coefficient of vari. .e obtained with this type of ipstrumentation ap-
proaches that of blood tests at about + 8 mg%.

D. Operator Degree is not required, but needs one day of preliminary training in conduct of test and
evaluation of results and reporting; yearly recurrent seminar is desirable.

E. Cost Initial cost of instrument is about $5000.00, with less than a dollar required for
supplies to support each test. Each instrument can be used thousands of times, making
a single test very expensive, but many tests inexpensive.

F. Legality In most states this method has evidential status equivalent to the blood alcohol test,

when calibration a- © erator coinpetence are assured.



APPENDIX IE

PORTABLE ALCOHOL DETECTION INSTRUMENTS

ELECTRONIC | ENZYMATIC | CHEMICAL
FUEL CELL

SPECIFICITY High High Minimum
SENSITIVITY ~10mg% | ~16mg% | >20mg%
PRECISION +5 mg% +5 mg% Unknown
RELIABILITY High High Medium
LEGALITY Evidential Evidential Cause
CALIBRATION Verified Unknown Unknown
SIZE Hand Pencil Pencil
PORTABILITY Excellent Excellent Excellent
STORAGE Indefinite Specified Indefinite
DOT APPROVED Yes No No
TEST CCST: 1 ~$ 500.00 ~$3.00 ~$2.00
TEST COST: 100 ~$550.00 ~$250.00 ~$175.00
TEST COST: 1000 ~$750.00 ~$1500.00 ~$1150.00

B-1



list. This fact is grounded in the demonstrated
specificity, sensitivity, and precision of the meth-
ods.

SELECTION STRATEGY

The degree to which any test method appears
desirable should depend primarily on the degree to
which it possesses the qualities necessary to per-
form acceptably in the Critical Performance Do-
mains. These qualities form the basis of whether
any test can produce valid data. Certainly specific-
ity, sensitivity, and precision are qualities that
would be routinely specified when considering
desirable attributes for any test in any situation.
Together, these attributes combine to establish the
level of confidence that can be assigned to the test
data, which ix perhaps the most elemental require-
ment of all.

Appreciation of confidence in the test is basic to
the Boundary Performance Domain of Legality, a
long-standing issue for alcohol testing, and perhaps
the most critical boundary issue for the FAA. An
important question in this area is whether the etha-
nol test data will be used in a court of law for
prosecution, or merely to determine the status of
affected persons in administrative hearings. In ei-
thercase, however, legal chailenges concerning the
validity of the test data will likely be forthcoming.
It would appear that obtaining the highest quality
alcohol test data possible would help guard against
improper accusations. This can best be accom-
plished by using a test method with superior
qualities in the Critical Performance Domains.

After assuring that the methods under conisider-
ation possess the qualities to meet these require-
ments, the strategy for selecting a test method(s)
must then define which of the Boundary Perfor-
mance Domains are relevant to the intended pur-
pose. For example, Portability would only be
Televant for field applications, where no location
for a fixed instrument would be likely or desirable,
where a single person was responsible for testing
large numbers of persons in many locations, or
where quick results are needed.

Cost-Per-Test would also be an important con-
sideration. In the case where only one ora few tests
would be required, the methods with initial costs of
only two or three dollars would be more cos:-
effective. However, when large numbers of per-
sons are to be tested, or when a single person is
responsible for testing persons at many locations,
the methods with higher initial cost, but long-term
economy, would be preferable.

The question of who would administer such
tests must also be studied. For the portabie test
methods, education and training on specific instru-
ments are not such large considezations, as those
instruments can be mastered in about one day.
However, a related, and more important concept, is
whether someone who has not been educated in
forensic methods and the evidential aspects of
administering tests and testifying about the results
in legal proceedings can be considered competent.
This issue impacts the Legality domain.

The juxtaposition of these requirements, to-
gether with consideration of the degree to which a
test method must meet the Critical Performance
Tequirements, forces a path(s) for sziection of the
test method(s).

Inmany situations as.ngle method would appear
to be the best choice. For example, a fixed-location
blood test capability or infrared electronic instru-
ment could be available in a FAA clinic or FAA-
approved forensic laboratory; portable instruments
of evidential quality could also be given to spe-
cially trained inspectors for more widely distrib-
uted field applications. In other situations two or
more methods might be combined to assure proper
testing. This is especially true when a method of
lesser stature, such as a portable chemical instru-
ment, is used as a field test, and then must be
verified by a more esteemed procedure (e.g., biood
test). Such a diversity of test methods application
may be necessary for the FAA, which is respon-
sible for regulatory activities in many environ-
ments.

Within this context, selection of alcchol test
equipment can proceed. First, selection of the test
method technology requires comparison of the
degree to which the generic qualities of prospective
test method technologies meet the requirements of
the Critical and Boundary Performance Domains
relevant to the environments of usage and goals of
the FAA. Assignment of relative values to each
performance domain, and analysis of the degree to
which each technology performs within the do-
main, provides comparative ratios of the relative
efficacies of alcohol test method technologies. Sec-
ond, the selection of any particular test instrament
within a chosen test methodology can be enhanced
by analyzing the degree to which individual instru-
menis exemplify the generic qualities embodied by
the test method technology. Comparison of the
degree to which the individual attributes for any


SELECTION CRITERIA FOR ALCOHOL DETECTION METHODS

INTRODUCTION

Analysis of the amount of ethanol a person has
consumed can now be provided by an abundance of
equipment utilizing several different technologies.
Instruments are available to test ethanol content of
blood, breath, and/or saliva; among these are fixed-
location devices for testing of blood through enzy-
matic or gas chromatographic analysis and infrared
electronic devices for testing of exhaled breath
samples. Portable devices are also available for
breath and saliva testing; these devices use either
electronic technology based on fuel-cell or tin-
oxide sensor techniques, enzymatic reactions simi-
lar to the fixed blood test method, or chemical
analysis based on oxidative reactions between a
crystalline medium and the test sample.

Selection of a particular device or technology
requires consideration of the performance required
of equipment within various domains and the in-
tended environment. Relevant domains of perfor-
mance criteria include the general, but critical,
qualities that all alcohol detection methods should
possess, such as high specificity and selectivity.
Certain boundary conditions upon which selection
of a potential alcohol detection method would be
merited include more unique attributes such as
portability and cost-per- test. The relative values
assigned to the performance domains are also im-
portant, since the combination of traits existent for
any particular detectionmethod/device being evalu-
ated may create dissonance about its selection. For
example, a unique quality such as portability, which
may make one methad extremely desirable, may
also cause that method to be easily rejected because
of violation of one of the more essential domains,
suchas specificity. Thus, the selection of a“method
of choice” requires careful analysis of three impor-
tant factors: 1) the intended situation or purpose, 2)
the performance domains that are particularly rel-
evant or irrelevant for that situation or purpose, and
3) how any particular method, or exemplar thereof,
fulfills the requirements. Within this context, a
schema for selection of an alcohol detection
method(s) may be developed.

CRITICAL PERFORMANCE DOMAINS

SPECIFICITY, Alcohol detection methods
should measure only the ethanol level in vivo, since
false positives would likely prejudice any person so
labeled. Many substances other than ethanol can
produce false positives in certain types of equip-
ment. Among these, naturally occurring aldehydes
and ketones are particularly important because of

inherently high levels associated with certain medi-
cal conditions. Similarly, exposure to compounds
found in various industrial environments is also a
common source of false positives; included are
other alcohols, such as methanol and isopropanol,
as well as hydrocarbons and industrial solvents
found abundantly in many aviation environments.

The specificity of ethanol detection methods
varies greatly; blood test methods provide the great-
est confidence. Infrared and fuel-cell electronic
methods, as well as enzymatic methods, also enjoy
high specificity, although interactions with other

TABLE 1. ALCOHOL DETECTION METH-
ODS SPECIFICITY

FIXED METHODS

BLOOD TEST High specificity. Uses
enzymatic reactions or
gas chromatographic

techniques.

ELECTRONIC

High specificity.
(INFRARED)

Interactions with other
substances have been
shown only in the
Fresence of high
ethanol.

PORTABLE
METHODS

ENZYMATIC High specificity. Uses
same reactions as

blood test.

ELECTRONIC (FUEL

High specificity. No
CELL

interactions with
substances other than
ethanol have been
found.

ELECTRONIC (TIN

Low specificity. Reacts
OXIDE)

with hydrocarbons and
other alcohols

CHEMICAL Low specificity. Reacts
with other commonly
found aldehydes and
ketones, as well as

other alcohols .

+ yet



. Precision

. Operator

. Cost

. Legality

. Location

. Storage

Calibration
Reliability

Qualitative - coefficient of variance depends on integrity of chemicals and color
vision of operator. Response is especially difficult to judge at aicohol levels
approaching zero.

Needs one hour training seminar, must have adequate color vision; normal color vision
is desirable.

Cost per single sample is about $2.00, with discounting to about $1.15 for purchase
0f1000 units or more. Each instrument can be used one time, making administra-
tion of many tests very costly, but one test very inexpensive.

This test method provides the least valid evidence for use in prosecution of a
person suspected of using ethanol illegally; such evidence has been used to show
cause for further analytical testing.

This type of screening device may be used at any location.

This type of instrument can be stored for an indefinite period in a closed container. It
tay be susceptible to high heat znd UV light.

The calibration is set by the manufacturer, with no field calibration practicable.

Reliability is generally satisfactory, but it depends on the conditions of storage and
use. Degradation of the specific instrument and/ or data obtained can occur over
time.

C4

US. GOVERNMENT PRINTING OFFICE: 8991 - SoL470/40(24


Technical Report Documentation Page

4. Report No. if 2. Government Accession No.

DOT/FAA/AM-91/12 |

3. Recipient s Catalog No.

4, Title and Subtitle

SELECTION CRITERIA FOR ALCOHOL DETECTION METHODS

5. Report Dore

ust 1997
3. Berforming Organtaanan Cade

8. Performing Orgamzation Repart No.

7 Avbor's) Carnet A. McLean, Bruce C. Wilcox, and

Dennis V. Canfield

9. Performing Organization Nome and Address
FAA Civil Aeromedical Institute
P.O. Box 25082

Oklahoma City, Oklahoma 73125

TO. “Work Unit No. (TRAIS)

Ti. Contract or Grant No,

33. Type of Report and Period Covered

12. Sponsoring Agency Nome and Address
Office of Aviation Medicine
Federal Aviation Administration
800 Independeace Avenue, S.W.
Washirgton, D.C. 20591

14. Sponsoring Agency Code

15. Supplementary Notes

Work was accomplished under approved task AM-B-90~PHY-152.

16. Abstract

The potential need for testing workers in the aviation industry for job-related
alcohol abuse requires the development of a testing strategy based, in part, on
selection of alcohol test instruments appropriate to the specific goals of the

Federal Aviation Administration. The extensive availability of test instruments

with varying capabilities and limitations makes selection of alcohol test instruments
difficult technolegically, with a considerable potential for choosing test instrumentd
of inappropriate character. The considerations outlined herein are intended to assis#
in the selection process.

17. Key Words 18. Distibution Statement

Alcohol Decument is available to the public

Breathalyzer through the National Technical
Information Service, Springfield,

Virginia 22161. .

19. Security Clossif. (of this report) 20. Security Classif. (of this page) 21- Ne. of Pages | 22. Price

Unclassified

Unclassified 15

Form DOT F 1700.7 (8-72) Reproduction of completed page authorized


NOTICE

This document is disseminated under the sponsorship of
the U.S. Department of Transportation in the interest of
information exchange. The United States Government
assumes no liability for the contents or use thereof.


G. Location

This type of instrumentation should be in a certified breath alcohol testing
laboratory.

H. Storage This type of instrumentation requires no special storage, and is designed for continual
operation.

I. Calibration Demonstration of calibration is required every six months to maintain certification.
Actual calibration is rarely necessary, but an internal heat source is required to dry
the tested breath sample.

J. Reliability This instrumentation is extremely reliabie.

PORTABLE TEST METHODS

i. ENZYMATIC:

A. Sensitivity The lowest valid quantification level for this type of test should be about 10 mg%, zhe
same as 2 blood test.

B. Specificity _Is highly specific for ethanol; uses alcohol dehydrogenase.

C. Precision The coefficient of variance afforded by this method should equal that of the blood test.

D. Operator Degree is not required, but needs one hour of preliminary training in conduct of test and
evaluation of results and reporting, recurrent one hour seminar is desirable yearly, may
administer test in the field.

E. Cost A single test costs $3.00, with the estimated cost for purchase of 1000 units at about
$1500. Each instrument can be used one time, making the administration of many
tests very expensive, while a single test is relatively inexpensive.

F. Legality This method has qualitative reliability for use as evidence in the prosecution of a
person suspected of using ethanol illegally. This type of evidence could also be used to
show cause for further analytical testing.

G. Location This type of screening device may be used at any location.

H. Storage This type of test has a specified shelf life.

1. Calibration The calibration is set by the manufacturer, with no field calibration practicable.

J. Reliability This is a new method with face validity and apparent reliability, but it is essentially
unproven in portable form.

IV. ELECTRONIC:

FUEL CELL

A. Sensitivity | Thelowest valid quantification level obtained with this type cf instrumentation is nearly
equivalent to the blood test and enzymatic methods (about 10 mg%).

B. Specificity This method is impervious to false positives by substances other than ethanol.

C. Precision The coefficient of variance obtained with this type of instrumentation approaches that
of blood tests at about + 8 mg%.

D. Operator Degree not required, one day preliminary training in conduct of test and evaluation

of results and reporting; recurrent seminar desirable yearly.

C2