EXPLANATION OF THE TEST
Alcohol intoxication can lead to loss of alertness, coma,
death and as well as birth defects. The BAC at which a
person becomes impaired is variable. The United States
Department of Transportation (DOT) has established a BAC of
0.02% (0.02g/dL) as the cut-off level at which an individual
is considered positive for the presence of alcohol.1-3
Determination of ethyl alcohol in blood and saliva is
commonly used for measuring legal impairment, alcohol
poisoning, etc.Gas chromatography techniques and enzymatic
methods are commercially available for the determination of
ethyl alcohol in human fluids. Saliva Alcohol Test is
designed as the screen tool to rapidly determine if the BAC
level is higher than 0.02% by testing saliva specimen.
PRINCIPLE OF THE PROCEDURE
Saliva Alcohol Test is based on the high specifity of
alcohol oxidase (ALOx) for ethyl alcohol in the presence of
peroxidase and enzyme substrate such as tetramethylbenzidine
(TMB) as shown in the following:
 The distinct color on reactive pad could be observed in
less than 20 seconds after the tip was contacted with saliva
samples with the ethyl alcohol concentration greater than
0.02%. It should be pointed out that other alcohols such as
methyl, propanyl and allyl alcohol would develop the similar
color on the reactive pad. However, these alcohols are not
normally present in saliva.
MATERIALS PROVIDED
1. Instruction for use
2. Saliva Alcohol Test Strip
Each test contains these materials：
Tetramethylbenzidine (TMB) 0.12mg
Alcohol oxidase (EC) 0.5 IU
Peroxidase(EC) 35 IU
Proteins 0.15mg
MATERIALS REQUIRED BUT NOT PROVIDED
1. Timer or clock
PRECAUTIONS
1. For in vitro use only.
2. Do not use the product beyond expiration date.
3. Handle all specimens as potentially infectious.
4. The product is sensitive to the presence of alcohol and
moisture.After open the package, the test device should be
used immediately.
SPECIMEN COLLECTION AND PREPARATION
1. Nothing should be placed into the mouth of the subject
for at least 10 minutes prior to saliva collection. This
includes food, drink, tobacco products or other materials.
2. Saliva specimen can be collected in a sputum cup or a
clean container, or directly applied to the reaction pad of
the test strip.
3. Avoid contact with skin by wearing gloves and proper
laboratory attire.
QUALITY CONTROL
Good laboratory Practice recommends the daily use of
control material to validate the reliability of device.
Commercially available controls that contain sodium azide or
other preservatives that will inhibit the enzyme activity
cannot be used with Saliva Alcohol Test.
Saliva Alcohol Test may be qualitatively verified by using
a test solution prepared by adding 10 drops of ethanol
alcohol into 8 oz of distill water. This solution should
show a distinct positive result.
PROCEDURE
1.Open the foil package and remove the test strip.
2. Saturate the reactive pad by dipping the reaction pad
into the saliva specimen collected in a sputum cup, or by
applying saliva directly to the reaction pad. After 10
seconds, shake off the excess saliva.
3. Immediately start timer and at 2 minutes, compare the
reactive pad with the provided colored chart.
Results after more than 2 minutes may be not accurate
INTERPRETATION OF RESULTS
Negative: Almost no color change by comparing with the
background. The negative result indicates that the BAC is
less than 0.02%.
Positive: A distinct color developed all over the pad. The
positive result indicates that the BAC is 0.02% or higher.
Invalid: The test should be considered invalid If only the
edge of the reactive pad turned color that might be ascribed
to insufficient sampling. The subject should be re-tested.
LIMITATION OF PROCEDURE
Saliva Alcohol Test is designed for use with human saliva
only. A positive result indicates only the presence of
alcohol and does not indicate or measure intoxication.
There is a possibility that technical or procedure error
as well other substances in certain foods and medicines may
interfere with the test and cause false results. Please
refer to “ Interference” section for list of substances that
will interfere the test results.
EXPECTED RESULTS
Saliva Alcohol Test is a semi-quantitative assay. It
identifies alcohol in human saliva at a concentration of
0.02% BAC.
PERFORMANCE CHARACTERISTICS
A. Accuracy
The following data were obtained based on 86 clinical saliva
samples.
Sensitivity96%
Specificity89%
Accuracy92%
B. Sensitivity
Detection limit at least at10mg/dL (0.01g/dL)
C. Interference
The following substances may interfere with the SEO Rapid
Alcohol Test:
Strong oxidizers Ascorbic acid
Tannic acid Polyphenolic compopunds
Mercaptans Uric acid
Bilirubin Oxalic acid
These compounds are not normally present in sufficient
amount in saliva to interfere with the test. However, the
precautious step must be taken so that these materials are
not introduced into the mouth during the 10 minutes test
period proceeding to the test.
REFERENCES;
1. National highway traffic safety administration
NHTSA),DOT, Federal Register. 59:147, August 1994, pp
22382-90
2.Bergemeyer, H.U., et.al, Methods of Enzyme Analysis, 3rd
ed. Vol. II, 1983, p143
3. Jones A.W., Clin. Exp. Pharmacol. Physiol. Vol. 6, 1979,
pp 53-59
4. McCall K.E.L., et.al, Clin. Sce. Vol. 56, 1979, pp
283-286
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