Description
Rapid, single-action screening test for the semi-quantitative determination of alcohol in saliva.
For self-testing, not for in vitro diagnostic use.

How to use
Before testing, allow the test strip in the package to reach room temperature (15-30°C). Do not put anything in your mouth for 15 minutes before starting the test. This includes soft drinks, tobacco products, coffee, mints, and food, etc.
1. Spit the saliva into the collection container.
2. Open the foil pouch and remove the test strip. Observe the test pad at the end of the strip. If the test pad is blue before applying the saliva sample, do not use it.
3. Saturate the reagent pad with saliva from the collection container or by applying saliva directly to the pad. (It usually takes 6-8 seconds for saturation.) Start the timer immediately after applying saliva.
4. Read the result after 2 minutes. Compare the color of the test pad to the color chart on the foil package to determine the relative blood alcohol concentration.
Positive: The rapid breathalyzer test strip will change color if alcohol is present in the saliva. The color can range from light blue with a relative blood alcohol concentration of 0.50 g/liter to dark blue with a relative blood alcohol concentration close to 1.50 g/liter. This range of swab colors allows for an approximate reading of the relative blood alcohol concentration. The test may produce colors that appear to be between two adjacent colored swabs.
NOTE: The rapid breathalyzer test strip is highly sensitive to the presence of alcohol. A lighter blue color than the colored pad corresponding to 0.50 g/liter should be interpreted as a positive result for the presence of alcohol in saliva but with a relative blood alcohol concentration less than 0.50 g/liter.
Negative: If the rapid alcohol test strip shows no color change, this result should be interpreted as negative, indicating that no alcohol has been detected.
Void: If the reactive swab is blue before applying the saliva sample, do not use it.
NOTE: If the outer edges of the colored swab produce a slight stain, but most of the swab remains colorless, the test should be repeated to ensure complete saturation of the swab with saliva. The test cannot be reused.

Components
Reagents: tetramethylbenzidine, alcohol oxidase (EC 1.1.3.13), peroxidase (EC 1.11.1.7), other additives.

Warnings
- Read the entire package leaflet before performing the test.
- For self-testing, not for in vitro diagnostic use.
- For external use only.
- Do not use the test after the expiration date printed on the package.
- Do not use the test if the foil pouch is torn or damaged.
- Single-use. Dispose of after first use.
- The test device must remain in the sealed pouch until use.
- A contaminated or contaminated urine sample may give false results.
- Keep out of reach of children.
Restrictions
1. Failure to wait 15 minutes after eating, drinking, or smoking before taking the test may result in incorrect results due to possible contamination of saliva with interfering substances.
2. The rapid breathalyzer test strip is highly sensitive to the presence of alcohol. Alcohol vapors in the air can sometimes be detected by the rapid breathalyzer test strip. Alcohol vapors are present in many public buildings and homes. Alcohol is a component of many household products such as disinfectants, deodorants, perfumes, and glass cleaners. If you suspect alcohol vapors are present in the environment, it is recommended to perform the test in an area free of vapors.
3. Ingesting or using over-the-counter medications and products containing alcohol may produce positive results.

Conservation
The test should be stored at 2-30°C (36-86°F) in its sealed foil pouch. Test performance may be degraded if storage temperatures exceed 30°C. If the product is refrigerated, the test should be brought to room temperature before opening the pouch.
Shelf life in intact packaging: 24 months.

Format
Package containing: test strip, collection container, package insert.

Cod. DAL-801H