Course

Training and Certification for AlcoSmart® Collectors

The information provided is intended to support to train and certify collectors of the AlcoSmart® CLIA-Waived Saliva Alcohol Test. Please review and study the following information carefully. A multiple-choice test will be administered at the end of this program.

Intended Use

The AlcoSmart® 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. AlcoSmart® provides a preliminary analytical test result. For a quantitative analytical result or to determine the blood alcohol concentration, a positive AlcoSmart® result must be verified using an acceptable quantitative alcohol procedure and should be performed by a qualified professional.

Specificity

The AlcoSmart® will react with methyl, ethyl and allyl alcohols.
The AlcoSmart® test consists of a plastic strip with a reagent pad applied at the tip. The tip, on contact with saliva alcohol, will rapidly turn shades of green to dark blue depending on the amount of alcohol present.

Plastic strip

The AlcoSmart® is a visually intrepreted 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 disposed of properly according to your organizations policies and procedures. Never use AlcoSmart® after the expiration date marked on the outside of each container. Do not remove dessicants from container.

Test Principle

It is well established that the concentration of alcohol in saliva is comparable to that in blood. The reactive pad of the AlcoSmart® employs a solid phase chemistry which uses a highly specific enzyme reaction.

Test Procedtlr

  1. Ensure the donor has not placed anything in the mouth for 10 minutes prior to beginning the test. This includes non-alcoholic drinks, tobacco products, coffee, breath mints, food, etc..
  2. Open the container and remove a test strip. Immediately re-cap the container. Be careful to avoid touching the reagent pad of the test strip
  3. Add a drop of saliva to the reactive pad at end of strip from mouth or sputum cup. Immediately start timer.
  4. At 2 minutes, observe the color change (if any) in the reactive pad. Results obtained after more than 2 and a half minutes 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 container label.
  6. If required by your organization, complete AlcoSmart® Test Record

Interpreting Test Results

Negative Results

A result where the reagent pad shows no color change (remains white or cream colored) should be interpreted as being negative (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).

Positive Results

AlcoSmart® produces a color change in the presence of saliva alcohol ranging from a light green-blue color at 0.02% blood alcohol concentration to a dark blue-green 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. AlcoSmart® may produce colors that appear to be adjacent between color blocks.


AlcoSmart® 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.

Limitations of the Procedure

Failure to wait 10 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.


AlcoSmart® is designed and calibrated to be interpreted two minutes after saturation of the reactive pad. Waiting longer than two minutes may result in erroneous results or false positive results.


AlcoSmart® is highly sensitive to the presence of alcohol. Alcohol vapors in the air are sometimes detected by the AlcoSmart® test. 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.

Product Stability and Storage

AlcoSmart® test strips are moisture sensitive. The entire test kit must be used within the stated stability timeframe after the initial breaking of the foil seal of the container. The stability timeframe is printed on the label of the containter.
Record date on the label of the container after first breaking the foil seal as shown below:

AlcoSmart® should be stored at room temperature (15°- 30°C or 59 - 86°F) until the expiration date. If storage temperature exceeds 86°F (30°C), degradation of the product and performance may occur.


If the product is refrigerated, the AlcoSmart® test must be brought to room temperature prior to opening the container.