Function： Rapid Alcohol Test Strip In-vitro Use Only INTENDED USE Rapid Alcohol Test is intended for use as a rapid method to detect the presence of alcohol in saliva for blood alcohol concentration (BAC) greater than 0.02%. It has been published that the concentration of alcohol in saliva is almost equal to that in blood.4 The rapid test is intended for the semi-quantitation of ethyl alcohol in human saliva. To confirm the concentration of positive specimens, an alternate, non-enzymatic technology such as headspace gas chromatography should be used. EXPLANATION OF THE TEST 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 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. 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. PRINCIPLE OF THE PROCEDURE 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: 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. PROCEDURE 1. Open the foil package and remove the test strip. 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. 3. Immediately start timer and at 2 minutes, compare the reactive pad with the provided colored chart. Results after more than 2 minutes may be not accurate INTERPRETATION OF RESULTS Negative: Almost no color change by comparing with the background. The negative result indicates that the BAC is less than 0.02%. Positive: A distinct color developed all over the pad. The positive result indicates that the BAC is 0.02% or higher. 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. LIMITATION OF PROCEDURE 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. 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. EXPECTED RESULTS Rapid Alcohol Test is a semi-quantitative assay. It identifies alcohol in human saliva at a concentration of 0.02% BAC. PERFORMANCE CHARACTERISTICS A. Accuracy 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