REF 24502 / DAL-801
English
Test Dipsticks
Collection Cup
Package Insert
Index of Symbols
Caution: read
instructions (warings)
carefully
Contains
sufficient for
“n” tests
Keep away from
sunlight
In vitro diagnostic
medical device
Use by
Disposable
device, do not re-
use
Store between 2-30°C
Expiration
date
Product code
Do not use if package
is damaged
Keep in a
cool, dry
place
Consult
instructions for
use
Manufacturer
Authorized
representative
in the
European
community
Product complies
with European
Directive
Hangzhou AllTest Biotech Co., Ltd.
#550, Yinhai Street
Hangzhou Economic & Technological Development Area
Hangzhou - 310018, P.R. China - Made in China
Rev.1.04.19
MedNet GmbH
Borkstrasse 10 - 48163 Muenster, Germany
Saliva Alcohol Rapid Test Dipstick(Saliva)
Package Insert
A rapid, one step screening test for the semi-quantitative detection of Alcohol in saliva.
For Forensic Use Only
【INTENDED USE】
The Saliva Alcohol Rapid Test Dipstick is a rapid, highly sensitive method to detect the
presence of alcohol in saliva and provide an approximation of relative blood alcohol
concentration.
This test provides a preliminary screen only. A more specific alternate chemical method
must be used in order to obtain a confirmed analytical result. Clinical consideration and
professional judgment should be applied to any test screen result, particularly when
preliminary positive screens are indicated.
【SUMMARY】
Two-thirds of all adults drink alcohol.¹ The blood alcohol concentration at which a person
becomes impaired is variable dependent upon the individual. Each individual has specific
parameters that affect the level of impairment such as size, weight, eating habits and alcohol
tolerance. Inappropriate consumption of alcohol can be a contributing factor to many
accidents, injuries, and medical conditions.
【PRINCIPLE】
It is well established that the concentration of alcohol in saliva is comparable to that of
2,3
blood.
The Saliva Alcohol Rapid Test Dipstick consists of a plastic dipstick with a reaction
pad attached at the tip. On contact with solutions of alcohol, the reaction pad will rapidly turn
colors depending on the concentration of alcohol present. The pad employs a solid-phase
chemistry which uses a highly specific enzyme reaction.
【REAGENTS】
Tetramethylbenzidine
Alcohol Oxidase (EC 1.1.3.13)
Peroxidase (EC 1.11.1.7)
Other additives
【PRECAUTIONS】
The Saliva Alcohol Rapid Test Dipstick is a visually interpreted test where color matching is
used to provide an approximation of relative blood alcohol concentration. Test materials that
have been exposed to saliva should be treated as potentially infectious. Do not use the
Saliva Alcohol Rapid Test Dipstick after the expiration date marked on the foil package.
【STORAGE AND STABILITY】
The Saliva Alcohol Rapid Test Dipstick is to be stored at 2-30°C (36-86°F) in its sealed foil
package. If storage temperatures exceed 30°C, the test performance may degrade. If the
product is refrigerated, the Saliva Alcohol Rapid Test Dipstick must be brought to room
temperature prior to opening the pouch.
【MATERIALS】
Timer
【DIRECTIONS FOR USE】
Allow the pouched dipstick to equilibrate to room temperature (15-30C) prior to
testing.
1. Avoid from placing anything in the mouth for fifteen (15) minutes prior to beginning of the
test. This includes non-alcoholic drinks, tobacco products, coffee, breath mints and food,
etc.
2. Spit the saliva into the collection cup.
3. Open the foil package and remove the test dipstick. Observe the reactive pad on the end
of the test dipstick. If the reaction pad has a blue color before applying saliva sample, do
not use.
4. Saturate the reactive pad with saliva from collection cup or by applying saliva directly to
the pad. (It usually takes 6-8 seconds to be saturated.) Start timer immediately after
saliva application.
5. Read result at two (2) minutes. Compare the color of the reaction pad with the color
chart on foil pouch to determine the relative blood alcohol level.
Materials Provided
Materials Required But Not Provided
【INTERPRETATION OF RESULTS】
Positive: The Saliva Alcohol Rapid Test Dipstick will produce a color change in the presence
of saliva alcohol. The color will range from light blue color at 0.02% relative blood alcohol
concentration to a dark blue color near 0.30% relative blood alcohol concentration. Color
pads are provided within this range to allow an approximation of relative blood alcohol
concentration. The test may produce colors that appear to be between adjacent color pads.
NOTE: The Saliva Alcohol Rapid Test Dipstick is very sensitive to the presence of alcohol. A
blue color that is lighter than the 0.02% color pad should be interpreted as being positive to
the presence of alcohol in saliva but less than 0.02% relative blood alcohol.
Negative: When the Saliva Alcohol Rapid Test Dipstick shows no color change this should
be interpreted as a negative result indicating that alcohol has not been detected.
Invalid: If the color pad has a blue color before applying saliva sample, do not use the test.
NOTE: A result where the outer edges of the color pad produces a slight color but the
majority of the pad remains colorless the test should be repeated to ensure complete
saturation of the pad with saliva. The test is not reusable.
【LIMITATIONS】
1. Failure to wait 15 minutes after placing food, drink, or other materials (including smoking)
in the mouth before running the test can produce erroneous results due to possible
contamination of the saliva by interfering substances.
2. The Saliva Alcohol Rapid Test Dipstick is highly sensitive to the presence of alcohol.
Alcohol vapors in the air are sometimes detected by the Saliva Alcohol Rapid Test
Dipstick. Alcohol vapors are present in many institutions and homes. Alcohol is a
component in many household products such as disinfectant, deodorizers, perfumes, and
glass cleaners. If the presence of alcohol vapors is suspected, the test should be
performed in an area known to be free of vapors.
3. Ingestion or general use of over-the-counter medications and products containing alcohol
can produce positive results.
【PERFORMANCE CHARACTERISTICS】
The detection limit on the Saliva Alcohol Rapid Test Dipstick is from 0.02% to 0.30% for
approximate relative blood alcohol level. The cutoff level of the Saliva Alcohol Rapid Test
Dipstick can vary based on local regulations and laws. Test results can be compared to
reference levels with color chart on the foil package.
【ASSAY SPECIFICITY】
The Saliva Alcohol Rapid Test Dipstick will react with methyl, ethyl and allyl alcohols.
【INTERFERING SUBSTANCES】
The following substances may interfere with the Saliva Alcohol Rapid Test Dipstick when
using samples other than saliva. The named substances do not normally appear in sufficient
quantity in saliva to interfere with the test.
A. Agents which enhance color development
Peroxidases
Strong oxidizers
B. Agents which inhibit color development
Reducing agents: Ascorbic acid, Tannic acid, Pyrogallol, Mercaptans and Tosylates,
Oxalic acid, Uric Acid.
Bilirubin
L-dopa
L-methyldopa
Methampyrone
【CONTROLS】
The Saliva Alcohol Rapid Test Dipstick may be qualitatively verified by using a test solution
prepared by adding 5 drops of 80 proof distilled spirits to 8 oz. (1 cup) of water. This solution
should produce a color reaction on the pad. The color reaction with alcohol in saliva is
somewhat slower and less intense than with alcohol in an aqueous solution.
【BIBLIOGRAPHY】
1. Volpicellim, Joseph R., M.D., Ph.D.: Alcohol Dependence: Diagnosis, Clinical Aspects
and Biopsychosocial Causes., Substance Abuse Library, University of Pennsylvania,
1997.
2. Jones, A.W.: Inter-and intra individual variations in the saliva/blood alcohol ratio during
ethanol metabolism in man., Clin. Chem. 25, 1394-1398, 1979.
3. MaCall, L.E.L., Whiting, B., Moore, M.R. and Goldberg, A.: Correlation of ethanol
concentrations in blood and saliva., Clin.Sci., 56, 283-286, 1979.
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