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ALCO Screen
2-Minute Saliva Test for Blood Alcohol
INTENDED USE
The ALCO-Screen™ saliva alcohol test is intended for use as
a rapid, highly sensitive method to detect the presence of alcohol
in saliva and to provide a semi-quantitative approximation of blood
alcohol concentration. For applications where a quantitative determination
of blood alcohol concentration is required, a positive ALCO-Screen
result must be verified using an acceptable quantitative alcohol
procedure. ALCO-Screen™ requires no special training, provided
that instructions are followed carefully. However, quantitative
follow-up testing should be performed by a qualified professional.
ALCO-Screen™ may also be used to non-quantitatively detect
the presence of alcohol in many other fluids, such as soft drinks,
blood serum, etc. (see limitations for further information.)
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SUMMARY
Excessive or inappropriate consumption of alcohol is one of the
most common and pervasive social problems in our society. It is
a contributory factor to many accidents, injuries and medical conditions.
Screening of individuals for alcohol consumption is an important
method for the identification of individuals who might be as risk
due to alcohol intoxication. Screening also provides additional
benefit as a deterrent against inappropriate alcohol consumption.
The blood alcohol concentration at which a person becomes impaired
is variable dependent upon the individual. Individual specific parameters
such as physical size, weight, activity level, eating habits and
alcohol tolerance all affect the level of impairment of the individual.
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TEST PRINCIPLE
It is well estabilished that the concentration of alcohol in saliva
is comparable to that of blood. The following gifure show the correlation
between saliva and blood alcohol. The regression line equation was:
Y=.003+1.075X (r=0.962, p<0.001)
correlation between blood and saliva alcohol in
concurrent samples
taken between 60 & 360 minutes after alcohol ingestion.
The ALCO-Screen™ test consists of a plastic strip with a reactive
pad applied at the tip. The tip, on contact with solutions of alcohol,
will rapidly turn shades of green to blue depending on the amount
of alcohol present. The reactive pad employs a solid phase chemistry
which uses a highly specific enzyme reaction.
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STORAGE AND STABILITY
ALCO-Screen™ should be stored at room temperature, not to
exceed 80 degrees F (27 degrees C). Under this condition, ALCO-Screen™
will perform according to specification until the expiration date
stamped on the package. If storage temperature exceeds 80 degrees
F, degradation of the product and performance may occur.
If the product is refrigerated, the ALCO-Screen™ test must
be brought to room temperature prior to opening the package.
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PRECAUTIONS
ALCO-Screen™ is a visually interpreted test where color matching
is used to provide an approximation of blood alcohol concentration.
As such, exact interpretation of results is not required in most
cases. However, persons who are color blind or visually impaired
may experience difficulty when a more specific interpretation is
required.
Test materials that have been exposed to saliva should be treated
as potentially infective. These materials should be returned to
the original foil package and disposed of properly.
Never use ALCO-Screen™ after the expiration date marked on
the outside of each test package.
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REAGENTS AND MATERIALS SUPPLIED
ALCO-Screen™ test which consists of a plastic strip with a
reactive pad applied to the tip.
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SPECIMEN COLLECTION AND HANDLING
see Test Procedure which follows.
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TEST PROCEDURE
1. Abstain from placing anything in the mouth for 15 minutes prior
to beginning the test. This includes non-alcoholic drinks, tobacco
produts, coffee, breath mints, food, etc.
2. Open the foil package and remove the test strip. Observe the
reactive pad on the end of the test strip. The pad should be a light
cream color. A test strip with a reagent pad which is dark tan in
color or otherwise discolored must be discarded.
3. Saturate the reactive pad with saliva from mouth or sputum cup.
Immediately start timer.
4. At two minutes observe the color change (if any) in the reactive
pad. A color change of green or blue indicates the presence of alcohol
and a positive result. Results obtained after more than 2 minutes
and 30 seconds may be erroneous.
5. Estimate the approximate blood alcohol concentration by comparing
the color of the reagent pad with the color chart appearing on the
test package.
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INTERPRETATION OF RESULTS
ALCO-Screen™ produces a color change in the presence of saliva
alcohol ranging from a light green-gray color at 0.02% blood alcohol
concentration to a dark blue-gray color near 0.30% blood alcohol
concentration. Color blocks are provided within this range to allow
an approximation of blood alcohol concentration to be made. ALCO-Screen™
may produce colors that appear to be between adjacent color blocks.
ALCO-Screen™ is very sensitive to the presence of alcohol.
A green color that is lighter than the 0.02% color block should
be interpreted as being positive to the presence of alcohol in saliva
but less than 0.02% blood alcohol.
A result where the reagent pad shows no color change (remains white
or cream colored) should be interpreted as a negative result (no
alcohol present.)
A result where the outer edges of the reagent pad produces a slight
color but the majority of the pad remains colorless should be repeated
to ensure complete saturation of the reagent pad with saliva. If
the second result is the same, the results should be interpreted
as being negative (no alcohol present).
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QUALITY CONTROL
The integrity of ALCO-Screen™ may be qualitatively verified
using a test solution prepared by adding 4 drops of 80 proof distilled
spirits to 8 oz. (1 glass) of water. This solution should provide
a color reaction equal to or higher (darker) than the 0.04% color
block.
The color reaction with alcohol in saliva is somewhat slower and
less intense than with alcohol in aqueous solutions. Other commercially
available controls should not be used with ALCO-Screen™.
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LIMITATIONS
Failure to wait 15 minutes after placing food, drink or other materials
in the mouth before running the test can provide erroneous results
due to possible contamination of the saliva by interfering substances.
ALCO-Screen™ is designed and calibrated to be interpreted
two minutes after saturation of teh reactive pad. Waiting longer
than two minutes may result in erroneous results or false positive
results.
ALCO-Screen™ may be used to detect the presence of alcohol
in fluids other than saliva.However, when used in this manner, the
color chart on the package does not apply. If alcohol is present
in the fluid, a color change ranging from a light green-gray to
black to cocoa brown will occur as the alcohol concentration increases.
Little or no color change may occur with pure alcohol due to the
absence of water which is required for the color change reaction.
When testing beverages, a result should not be considered positive
unless the pad changes to a very dark brown or black.
ALCO-Screen™ is highly sensitive to the presence of alcohol.
Alcohol vapors in the air are sometimes detected by the ALCO-Screen™.
Alcohol vapors are often present in many institutions and homes.
Alcohol is a component in many household products such as disinfectants,
deodorizers, and glass cleaners. If the presence of alcohol vapors
is suspected, the test should be performed in an area known to be
free of these vapors (such as outside).
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PERFORMANCE CHARACTERISTICS
Specifity
The ALCO-Screen™ will react with methyl, ethyl, and allyl alcohols.
ALCO-Screen™ will not react with alcohols having 5 or more
carbons, nor with glycine, glycerol, or serine. Theis property is
a result of the specifity of the alcohol oxidase enzyme extracted
from yeast.
Reagent Composition: (per test unit)
Tetramethylbenzidine 0.176 mg
Alcohol Oxidase (EC 1.1.3.1.3) 0.5 IU
Peroxidase (EC 1.11.1.7) 30 IU
Buffer 0.747 mg
Stabilizing Proteins 0.19 ug
Interferences
The following substances may interfere with the ALCO-Screen™
stick when using samples other than saliva:
Agents which enhance color development:
Reducing Agents:
Ascorbic acid, Tannic Acid, Pyrogallol, Mercaptans
and tosylates,
Oxalic acid, Uric acid
Bilirubin
L-dopa
L-methyldopa
Methampyrrone
The above named substances do not normally appear in sufficient
quantity in saliva to interfere with the test. However, care must
be taken that they are not introduced into the mouth during the
15 minute period preceding the test.
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