ChangZhou Realhealth Medical Devices Co., LTD.

Alcohol Testing Products

Beverage Alcohol Test Strip

  • Introduction

  • INTENDED USE
     
    SEO Rapid Urine Alcohol Test is intended for use as a rapid method to detect the presence of alcohol in urine greater than 0.04%.
     The rapid test is intended for the detection of ethyl alcohol in human urine. 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 Since the urine alcohol concentration is normally higher than that in saliva and blood, the cutoff concentration for alcohol in urine was set at 0.04%. Normally, it will take at least 30 minutes for the alcohol to be detected in saliva, blood and urine after drinking.3
     
    Determination of ethyl alcohol in urine, 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 to detect ethyl alcohol in urine specimens.

    PRINCIPLE OF THE PROCEDURE

    SEO 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:
                        ALOx/Peroxidase
    EtOH+TMB----------------------------CH3CHO+Colored TMB
     
    The distinct color on reactive pad could be observed in less than 60 seconds after the reaction pad was wetted with urine specimens with the ethyl alcohol concentration greater than 0.04%. 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 human urine.
     
    MATERIALS PROVIDED
    1. Instruction for use
    2. SEO Rapid Alcohol Test
        Each test contains these materials:
     
    Tetramethylbenzidine (TMB)        0.52mg[cy1] 
    Alcohol oxidase (EC)               0.15 IU
    Peroxidase(EC)                0.25 IU
    Proteins                      0.05mg
     
    MATERIALS REQUIRED BUT NOT PROVIDED
    1. Timer or clock
     
    PRECAUTIONS
    1. For in vitro use only.
    2. Do  use the product beyond expiration date.
    3. Handle all specimens as potentially infectious.
    4. The product is sensitive to the presence of alcohol and moisture.    After open the package, the test device should be used immediately.
     
    SPECIMEN COLLECTION AND PREPARATION
    1.Urine specimen can be collected in a sputum cup or a clean container.
    2. Avoid contact with skin by wearing gloves and proper laboratory attire.
     
    QUALITY CONTROL
    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.
     
    SEO Rapid Alcohol Test may be qualitatively verified by using a test solution prepared by adding 15 drops of ethanol alcohol into 8 oz of pooled human urine. This solution should show a distinct positive result.
     
    PROCEDURE

    1. Open the foil package and remove the test strip.
    2. Dipping the strip into the urine specimen collected in a sputum cup.
    3. After wetting the reaction pad in the middle (it will take about 30 seconds). Immediately start timer and at 4 minutes, compare the reactive pad with the provided color chart.

    Results after more than 5 minutes may be not accurate

    INTERPRETATION OF RESULTS
    Negative: Almost no color change by comparing with the background. The negative result indicates that the alcohol concentration is less than 0.04%.
    Positive: A distinct color developed all over the pad. The positive result indicates that the urine alcohol concentration is 0.04% 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
    SEO Rapid Alcohol Test is designed for use 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
    SEO Rapid Alcohol Test is a quantitative assay. It identifies alcohol in human urine specimens at a concentration of 0.04%.
     
    PERFORMANCE CHARACTERISTICS
     

    1. Accuracy

     
    The following data were obtained based on 56 clinical saliva samples.

       >0.04% (Spiked) 0  
    SEO Strip Test(+) 26 0  
    SEO Strip Test(-) 1 29  
      96% 100% 98%
      Sensitivity Specifity Agreement
     

                   
    B. Detection Limit
     
    Detection limit at 20mg/dL (0.02g/dL)
     
    C. Interference
     
    The following substances may interfere with the SEO Rapid Alcohol Test:
     
    Strong oxidizers           Ascorbic acid
    Tannic acid                 Polyphenolic compopunds
    Mercaptans           Uric acid
    Bilirubin                Oxalic acid
     
    These compounds are not normally present in sufficient amount in urine to interfere with the test.
     


    WeChat public two-dimensional code
    ChangZhou Realhealth Medical Devices Co., LTD. ©2015- REALHEALTH CHINA ALL RIGHTS RESERVED

    Product

    Technical

    News

    Return

    Back to the top