Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or...
Reexamination Certificate
2000-02-29
2002-05-07
Leary, Louise N. (Department: 1623)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
C435S283100, C435S975000
Reexamination Certificate
active
06383736
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates in general to personal drug testing kits and more particularly to the packaging for storing the drug-sensitive pads of a personal drug testing kit and to the method for testing the presence of a certain drug or drugs that have possibly been taken by the user. The invention is also applicable to the storage of the drug-sensitive pads which must be protected from any contact with ultraviolet light, moisture, or air.
BACKGROUND OF THE INVENTION
It is often necessary for a parent or an employer to be able to determine whether their son, daughter, or employee have ingested any of a number of illegal and harmful drugs, such as marijuana, cocaine, opiates, PCP, amphetamines, methamphetamines, and barbituates. While there are numerous known means for detecting these drugs, these known means often include the taking of a blood or urine sample. It is not practical, however, for a parent or an employer to take such a blood or urine sample to quickly determine whether their son, daughter, or employee has ingested such drugs. Further, the use of urine samples presents numerous opportunities for manipulation, as has been well-documented. For these reasons, at this time, it is nearly impossible for a parent or employer who suspects that their son, daughter, or employee is under the influence of any of these drugs to test their son, daughter, or employee to accurately determine whether they are in fact under the influence of any of these substances.
Accordingly, there is a need for a method and testing kit that can be used by a parent or an employer to test a person for the presence of certain drugs, such as marijuana, cocaine, opiates, PCP, amphetamines, methamphetamines, and barbituates. Such a testing kit should be capable of providing immediate, accurate, and reproducible results without the taking of the user's blood or urine. The testing kit should be portable, so that it may be discreetly carried in a wallet, pocket or purse and used at a variety of locations. The testing kit also should be inexpensive so that parents and employers will be apt to purchase the kit. The testing kit should also be able to detect more than one drug, as the person may have ingested any one of a number of different substances. The kit should also be self-contained, that is, all the necessary items, including instructions and any charts or graphs, should be included within or on the packaging. The test kit should also be easy to administer—easy enough so that any one can use the test kit without any specialized training.
A testing kit that is able to detect these drugs by testing the user's saliva may be capable of meeting these needs. For example, it is known that a person's saliva contains some of the same materials that may also be present in the person's blood. One example of the testing of a person's saliva is the determination of a person's blood alcohol level. A person's saliva contains the same concentration of alcohol as in that person's blood. Test kits have been developed for detecting the level of a person's blood alcohol in that person's saliva. These test kits utilize alcohol-sensitive pads that are formed from paper saturated with alcohol oxidase enzyme, alcohol peroxidase enzyme, dyes and a buffer. When these alcohol-sensitive pads are saturated with a person's saliva, they will change color according to the level of alcohol in that saliva. Such a personal blood alcohol testing kit is disclosed in U.S. Pat. No. 5,563,073.
Accordingly, there exists a need for a personal testing kit to detect the presence of certain drugs by testing the person's saliva.
SUMMARY OF THE INVENTION
In accordance with the present invention, a personal drug testing kit that is capable of detecting the presence of one or more drugs that have been ingested by the user is provided. The test kit determines whether certain drugs are present by analyzing the person's saliva, rather than their blood or urine.
The test kit is comprised of the packaging and the pad or pads that are stored within the packaging. The pads are chemically sensitive to certain predetermined drugs and are preferably impregnated with at least one enzyme that is sensitive to the particular drug that it is searching for, at least one dye, and at least one buffer. Each pad changes color when it is contacted with the user's saliva, but only if the user's saliva contains the particular drug for which the pad is intended to test. This change in color indicates that the person's saliva contains this particular drug, and thus the test will reveal by this change in color that the person has ingested the drug that is being tested.
Each drug-sensitive pad comprises a piece of paper saturated with one or more enzymes that are sensitive to each drug that is being tested. The paper is also saturated with dyes and a buffer. The drug-sensitive pads are preferably cut into small pieces less than one-half square inch in size. The drug-sensitive pads are attached to the end of a stick so that the user may place the drug-sensitive pad within his mouth to saturate the pad with saliva or may dip the drug-sensitive pad into saliva that has been collected in a cup. If more than one drug is being tested for, then a separate drug-sensitive pad that is specific to each drug being tested for may be mounted to the same stick so that all drugs may be tested for with one application of saliva to the plurality of pads mounted onto the stick.
The drug-sensitive pads are stored in a package. The package includes a first side wall comprised of a plurality of layers coupled together with at least one of the layers being formed from aluminum foil and a second side wall also comprised of a plurality of layers coupled together with at least one of the layers being formed from aluminum foil. The aluminum foil of the first and second side walls of the package may be formed from high-grade surgical aluminum foil. Similarly, the aluminum foil may be coated with a polymer. In either case, the package is formed by coupling together the outer edge of the first side wall with the outer edge of the second side wall to form an interior for storing at least one drug-sensitive pad. The package is intended to protect the drug-sensitive pads from ultraviolet light, moisture, and air.
The instructions for use and the identity of the drug being tested by each of the pads (if more than one drug-sensitive pad is being used to detect more than one drug) may be printed on the outside surface of one of the side walls of the packaging. Thus, by printing the instructions for use on the exterior of the package, a self-contained personal drug testing kit is provided.
The user performs the personal drug test after abstaining from eating or drinking for at least fifteen minutes prior to taking the test. The test is administered by saturating the drug-sensitive pad or pads at the end of the stick with the user's saliva. Once the pad or pads are completely saturated, the user waits approximately two minutes for the drug-sensitive pad or pads to change color. If any of the pads changes color, this indicates the presence of the drug for which that particular pad is testing. If there is no change in color, then that drug is not present. Thus, an easy-to-administer test is provided that is accurate and reproducible and does not require the taking of blood or urine.
REFERENCES:
patent: 5563073 (1996-10-01), Titmas
Leary Louise N.
Oppenheimer Wolff & Donnelly LLP
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