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4-Minute Saliva Test for Blood Alcohol
INTENDED USE
The Chematics ALCO-SCREEN 02TM saliva alcohol test is intended for
use as a rapid method to positively identify the presence of alcohol in
saliva for blood alcohol concentrations (BAC) greater than 0.02%. The
ALCO-SCREEN 02TM requires no special training provided that the
instructions are followed carefully.
BACKGROUND AND HISTORY
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 those who might be at risk due to
alcohol use, and may serve as a deterrent against inappropriate
alcohol consumption.
The BAC at which a person becomes impaired is variable, dependent upon the individual. Specific parameters such as physical size, weight, activity level, eating habits and alcohol tolerance all affect the level of impairment of an individual.
The United States Department of Transportation (DOT) has established a BAC of 0.02% as the level at which an individual is considered positive for the presence of alcohol.1 DOT provides for the use of screening devices using bodily fluids, including saliva, to detect the presence of 0.02% BAC or greater.1
ALCO-SCREEN 02TM is a screening device designed to determine the presence of 0.02% BAC or more in accordance with the DOT regulations.
PRINCIPLE2
It is well established that the concentration of alcohol in saliva is comparable
to that of blood.3,4,5,6
The following figure shows the correlation
between saliva and blood alcohol. The regression line equation is:
The ALCO-SCREEN 02TM test consists of a plastic strip with a reactive pad applied at the tip. The tip, on contact with saliva samples with alcohol in excess of 0.02% will produce a positive result, which is indicated by the development of a distinct colored line across the pad. The reactive pad employs a solid phase chemistry which uses the following highly specific enzyme reaction.
SPECIFICITY
The ALCO-SCREEN 02TM will react with methyl, ethyl, and allyl
alcohols. ALCO-SCREEN 02TM will not react with alcohols having 5 or
more carbons, nor with glycine, glycerol, or serine. This property is a
result of the specificity of the alcohol oxidase enzyme extracted from
yeast.2
REAGENT COMPOSITION: (per test unit)
Tetramethylbenzidine
0.027 mg
Alcohol Oxidase (EC 1.1.3.1.1) 0.12 IU
Peroxidase (EC
1.11.1.7)
0.4 IU
Non-Reactive
Ingredients
0.12 mg
INTERFERENCES
The following substances may interfere with the ALCO-SCREEN 02TM.
Peroxides
Strong oxidizers
Ascorbic acid
Tannic Acid
Pyrogallol
Mercaptans and tosylates
Oxalic acid
Uric Acid
Bilirubin
L-dopa
L-methyldopa
Methampyrone
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.
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 02TM is designed and calibrated to be interpreted four minutes after saturation of the reactive pad.
ALCO-SCREEN 02TM is sensitive to the presence of alcohol. Alcohol vapors in the air are sometimes detected by the ALCO-SCREEN 02TM. 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. To determine if alcohol vapors are present in the air, refer to the TROUBLE SHOOTING section.
For questions regarding the validity of test results, refer to the TROUBLE SHOOTING section.
PRECAUTIONS
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 02TM after the expiration date marked on the outside of each test package.
PROCEDURE
Note: For questions regarding the validity of test results, refer to the TROUBLE SHOOTING section.
RESULTS
ALCO-SCREEN 02TM produces a distinct colored line across the
reactive pad in the presence of saliva alcohol greater than 0.02%
BAC. A reagent pad that shows no distinct line should be interpreted
as less than 0.02% BAC.
STORAGE AND STABILITY
ALCO-SCREEN 02TM should be stored at room temperature, not to
exceed 80 degrees F (27 degrees C). Under this condition, ALCO-SCREEN 02TM
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 02TM test must be brought to room temperature prior to opening the package.
Maximum performance is assured if the ALCO-SCREEN 02TM test is performed at room temperature, not to exceed 80 degrees F (27 degrees C). The ALCO-SCREEN 02TM can be used in environments above 80 degrees F (27 degrees C) if performed within ten minutes after removal from the specified storage temperature 80 degrees F (27 degrees C). Failure to perform the test within ten minutes upon exposure to temperatures above 80 degrees F (27 degrees C) could cause degradation of product performance.
CONTROLS
The color reaction with alcohol in saliva is somewhat slower and less
intense than with alcohol in aqueous solutions.
The ALCO-SCREEN 02TM may be qualitatively verified by using a test solution prepared by adding 10 drops of 80 proof distilled spirits to 8 oz. (1 cup) of water. This solution should provide a positive result (distinct colored line) across the reactive pad of the test.
Commercially available controls that contain preservatives cannot be used with the ALCO-SCREEN 02TM.
TROUBLE SHOOTING
ALTERNATE PROCEDURE
This procedure is to be employed if alcohol vapors are determined to
be present, and/or alcohol vapors are suspected of interfering with the validity of the test results.
REFERENCES
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