One Step Alcohol Test Strip

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  A. Accuracy

Performance Characteristics

Rapid Alcohol Test is a semi-quantitative assay. It identifies alcohol in human saliva at a concentration of 0.02% BAC. 

Expected Results

There is a possibility that technical or procedure error as well other substances in certain foods and medicines may interfere with the test and cause false results. Please refer to Interference section for list of substances that will interfere the test results.

Rapid Alcohol Test is designed for use with human saliva only. A positive result indicates only the presence of alcohol and does not indicate or measure intoxication.

Limitation Of Procedure

Invalid: The test should be considered invalid If only the edge of the reactive pad turned color that might be ascribed to insufficient sampling. The subject should be re-tested.

Positive: A distinct color developed all over the pad. The positive result indicates that the BAC is 0.02% or higher.

Negative: Almost no color change by comparing with the background. The negative result indicates that the BAC is less than 0.02%.

Interpretation of Results

Results after more than 2 minutes may be not accurate

            3. Immediately start timer and at 2 minutes, compare the reactive pad with the provided colored chart. 

            2. Saturate the reactive pad by dipping the reaction pad into the saliva specimen collected in a sputum cup, or by applying saliva directly to the reaction pad. After 10 seconds, shake off the excess saliva.

            1. Open the foil package and remove the test strip.

Procedure

Rapid Alcohol Test may be qualitatively verified by using a test solution prepared by adding 10 drops of ethanol alcohol into 8 oz of distill water. This solution should show a distinct positive result.  

Good laboratory Practice recommends the daily use of control material to validate the reliability of device. Commercially available controls that contain sodium azide or other preservatives that will inhibit the enzyme activity cannot be used with SEO Rapid Alcohol Test. 

Quality Control

3. Avoid contact with skin by wearing gloves and proper laboratory attire.

2. Saliva specimen can be collected in a sputum cup or a clean container, or directly applied to the reaction pad of the test strip.

1. Nothing should be placed into the mouth of the subject for at least 10 minutes prior to salivacollection. This includes food, drink, tobacco products or other materials.

Specimen Collection And Preparation

4. The product is sensitive to the presence of alcohol and moisture.    After open the package, the test device should be used immediately.

3. Handle all specimens as potentially infectious.

2. Do not use the product beyond expiration date.

1. For in vitro use only.

Precautions

1. Timer or clock

Materials Required But Not Provided

Proteins    0.15mg

Peroxidase(EC)   0.35 IU

Alcohol oxidase (EC)   0.5 IU

Tetramethylbenzidine (TMB)   0.12mg 

Each test contains these materials:

2. SEO Rapid Alcohol Test

1. Instruction for use

Materials Provided

The distinct color on reactive pad could be observed in less than 20 seconds after the tip was contacted with saliva samples with the ethyl alcohol concentration greater than 0.02%. It should be pointed out that other alcohols such as methyl, propanyl and allyl alcohol would develop the similar color on the reactive pad. However, these alcohols are not normally present in saliva.

Rapid Alcohol Test is based on the high specifity of alcohol oxidase (ALOx) for ethyl alcohol in the presence of peroxidase and enzyme substrate such as tetramethylbenzidine (TMB) as shown in the following:

Determination of ethyl alcohol in blood and saliva is commonly used for measuring legal impairment, alcohol poisoning, etc.  Gas chromatography techniques and enzymatic methods are commercially available for the determination of ethyl alcohol in human fluids.  SEO Rapid Alcohol Test is designed as the screen tool to rapidly determine if the BAC level is higher than 0.02% by testing saliva specimen.

Alcohol intoxication can lead to loss of alertness, coma, death and as well as birth defects. The BAC at which a person becomes impaired is variable. The United States Department of Transportation (DOT) has established a BAC of 0.02% (0.02g/dL) as the cut-off level at which an individual is considered positive for the presence of alcohol. ^1-3

Rapid Alcohol Test is intended for use as a rapid method to detect the presence of alcohol in saliva for blood alcohol concentra