Abstract:
A urinalysis screening device is disclosed that comprises a container, a cap for the container which seals in the urine sample, and an assay assembly that fits into the container. The assay assembly contains a plurality of diagnostic strips that enables the urine to be analyzed for various substances

Description:
[0001]    This application claims priority based on Provisional Patent Application Ser. No. 60/832,824, filed Jul. 22, 2006, entitled: Urinalysis Screening Device. 
     
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    This invention relates to a urinalysis screening device, and particularly to an screening device that is useful as a diagnostic tool to detect the presence of drugs, hormones, metabolites, pathogens, or other substances of interest in urine. The device may also be referred to as a screening kit. 
         [0004]    2. Prior Art 
         [0005]    In the modern business and sports world, job applicants or sports participants are often tested for the presence of drugs, or other prohibited substances. For example, professional baseball and football players are subject to random testing to detect the presence of such substances as drugs or human growth hormone. This is conventionally done by urinalysis. It is desirable to be able to take a urine sample at the location where the participant is found, such as a sports stadium or playing field. 
         [0006]    In the business world, prior to being offered a job, applicants are tested for the presence of marijuana, cocaine and like substances. It is desirable to have a quick and easy way to collect a urine sample, and, hopefully, be able to analysis the urine instantaneously to detect the presence of prohibited substances. 
         [0007]    Urine assay devices are known in the art. For example, U.S. Pat. Nos. 6,805,837, and 6,805,838 describe and claim assaying devices for collecting specimens of urine in the field. U.S. Pat. Nos. 6,379,620 and 6,548,019 also show and claim devices for assaying urine and biological fluids in the field. The devices shown in these patents are complex, and relatively expensive to make. Less expensive and simpler devices are constantly being sought. 
         [0008]    The present invention differs from the assay device shown in the foregoing patents, in a number of ways, which make it easier and less expensive to manufacture, as will be seen from the description below. 
       SUMMARY OF THE INVENTION 
       [0009]    It is an object of the invention to provide as a urinalysis screening device or kit which overcomes the disadvantages of the devices of the prior art. 
         [0010]    It is a further object of the invention to provide an inexpensive urinalysis screening device or kit which is suitable for use in in-situ urine analysis. 
         [0011]    Other objects and advantages of the present invention will be apparent from the description below. 
         [0012]    In general, the urinalysis screening device or kit of the present invention comprises a container, a cap for the container which seals in the urine sample, and an assay assembly that fits into the container. The assay assembly contains a plurality of diagnostic strips that enables the urine to be analyzed for various substances 
     
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0013]    The above mentioned features and objects of the present invention will become apparent with reference to the following description taken in conjunction with the accompanying drawings wherein like reference numerals denote like elements and in which: 
           [0014]      FIG. 1  is a side view of the urinalysis screening device of the invention. 
           [0015]      FIG. 2  is a perspective view of the assay assembly that is a component of the urinalysis screening device of the invention. 
           [0016]      FIG. 3  is an exploded view of the assay assembly of the invention, showing the plastic cover that fits over the diagnostic strips. 
           [0017]      FIG. 4  is a close up cross sectional view of the diagnostic strip support plate forming a part of the assay assembly of the invention. 
           [0018]      FIG. 5  is a perspective view of the urinalysis screening device of the invention with parts broken away to show the assay assembly of the invention seated within the container. 
           [0019]      FIG. 6  is a side view of the urinalysis screening device of the invention showing a removable label on the outside of the container for obscuring the results of the test being conducted until the label is removed. 
           [0020]      FIG. 7  is a perspective view of the bottom surface of the cap for the urine container, showing the sealing ring to prevent urine from escaping from the container during transportation. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0021]    As seen in  FIGS. 1 , and  5 , the urinalysis screening device  10  of this invention comprises a container  12 , also referred to as a cup, having a circular, flat bottom  14 , curved vertical walls  16  and open top, or mouth  18 . The container  12  is preferably made of a rigid plastic, but can also be made of glass. Threads  20  for receiving a closure are molded into the outer surface of the walls  16  at the upper end thereof, and surround the mouth  18  of the container  12 . A closure or cap  22 , also having threads  24  on the inside thereof which are complementary to the threads  20  around the mouth  18  of the container  12 , screws onto the mouth  18  of the container  12 . The cap  22 , preferably made of plastic, has a rubber like sealant ring  26  on the inside surface that comes into contact with upper edges of the walls  16  of the container  12  when the cap  22  is screwed on, thus making it fluid tight. The cap  22  is preferably made of plastic, preferably polypropylene, but can be of any substance such as metal or similar material. The sealant ring  26  on the inside periphery of the cap  22  is preferably made of rubber, but can also be made of a rubber like material, such as rubberized silicone. As seen in  FIG. 5 , the walls  16  of the container  12  form a complete circle. In a preferred embodiment of the urinalysis screening device  10  of the invention, the container  12  is approximately 2 inches in diameter, and the walls  16  about 3.2 inches high. The container holds about 8 ounces of fluid. Plastic containers of the type described above can be purchased from Oocott Plastics, St. Charles, Ill. 60174-6042. 
         [0022]    Positioned inside the container  12  is a diagnostic test strip assembly  28 , also called a cup insert. The assembly  28  comprises an arcuate diagnostic test strip support plate  30  having a curvature that is adapted to conform to the inside surface of the walls  16  of the container  12 . The support plate  30  is made of a plastic material that is rigid, but has some flexibility. A support plate made of polystyrene is preferred. Thus, when introduced into the container  12 , the support plate  30  flexes outward so that the outer surfaces  32  of the support plate  30  closely align with and abut the inside surfaces of the container walls  16 . The support plate  30  occupies about ½ of the total surface area of the inside periphery of the container  12 . 
         [0023]    As best seen in  FIGS. 2 and 3  the support plate  30  has a plurality of spaced apart indentations or grooves  34  in it which extend from the bottom edge of the plate  30  to a point about ¾ of the height of the plate. In a preferred embodiment, the plate is about 0.060 inches thick, the grooves are about 0.005 inches deep, about 0.150 inches wide, and spaced apart from each other about 0.76 inches. A plurality of diagnostic test strips  36  are positioned in the grooves  34 , one to each groove. The diagnostic test strips  36  are capable of detecting a variety of substances in urine, such as marijuana, cocaine, amphetamine, barbiturate, benzodiazepine, ecstasy, methadone, methamphetamine, opiates, metabolites, propoxyphene, phencyclidine, tricyclic antidepressants, oxycodone, specimen adulterants, and alcohol. The test strips are available commercially, and can be purchased from W.H.P.M, Inc, El Monte, Calif. . . . Each test strip  36  comprises a backing  38 , having an upper  40  and lower  42  end. A wicking material  44  is positioned on the lower end  42  of the backing, and a reactive membrane  46  on the upper end  44  of the backing material . . . . The wicking material  44  serves to wick urine into the reactive membrane section  46  of each strip. The wicking material  44  can be made of any material that will wick up a liquid such as filter paper, unwoven papers, fiber glass and the like. Each reactive membrane  46  contains a chemical substance that reacts with a specific drug or other substance in the urine. Such test strips as have been described are well known to those skilled in the art. 
         [0024]    A clear plastic cover sheet  48  is bonded to the outer exposed surfaces  32  of the support plate  30 , and covers the test strips  36 , except for a section  50  at the very bottom thereof which contains exposed wicking material  44 . Thus each test strip  36  situated within a groove  34  is sealed off or isolated from adjacent test strips by the plastic cover  48  bonded to the exposed surfaces  32  of the support plate  30 , including those surfaces separating each test strip  36 , thereby preventing contamination of a specific test strip from adjacent test strips. The plastic sheet  48  is preferably made of polyester and is bonded to the available surfaces of the support plate  30  by means of an acrylic sealant. It is bonded to the support plate  30  after the diagnostic test strips  36  are placed in the grooves  34 . 
         [0025]    In a preferred embodiment of the invention, as seen in  FIG. 6 , the container  12  has a label  52  affixed to the outside wall surface thereof, and is coextensive with the exposed area of the support plate  30  inside the container  12 . The label  52  has a removable tab  54  which overlies the section of the assay assembly  28  providing the results of the urinanalysis, thus preventing an individual from reading the results unless the tab  54  is removed. This provides a level of privacy to the individual donating the urine specimen. 
         [0026]    The label  52  can also contain information on how to read the diagnostic test strips  36 . For example, if two lines are visible on the diagnostic strip  36 , the test result is negative. If any one or more of the diagnostic strips  36  has just one line at the top, it is “presumptive” positive. If no lines are present on a test strip  36 , or a line on the bottom is present, then the test is considered invalid or not working. This information can be placed on the label to assist the reader in interpreting the results of the tests. 
         [0027]    The principle of operation is that each user voids a specimen into the container  12  and then screws the cap  22  onto it, thus sealing the urine specimen in the container. The urine specimen is then wicked up through the exposed portion  50  of the wick  44  found on the bottom of each test strip  36 . Wicking is ensured by sealing the diagnostic test strip  36  in the groove  34  that is surrounded on three sides by the support plate  30  and a clear polyester cover  48  over the front of the support plate  30 , and bonded to all exposed surfaces of the support plate  30 . The sealing of this test strip  36  on all four sides creates a chamber that utilizes atmospheric pressure inside the chamber to prevent the specimen material from flooding over the test. The specimen material is then forced to wick up to the diagnostic membrane  46  from the base of the container  12  through the exposed wick  50  of the diagnostic strip  36 . The specimen fluid cannot wick down from the top of the container, as the grooves  34  in the support plate  30  do not extend all the way to the top, rather only about ¾ of the way. The diagnostic test strips  36  are thus sealed off from the atmosphere at their tops by the body of the support plate  30  and plastic cover  48  overlying them. 
         [0028]    After approximately three minutes, the removable tab  54  of the container label  52  is removed to reveal the results of the test. Temperature indicating dots are incorporated in the label  52  to help verify that the sample has not been substituted. A freshly voided urine sample should indicate a temperature between 92 degrees F. and 100 degrees F. Adulteration indicators can be added to the label  52  or assay assembly  28  to indicate if a given specimen sample has been adulterated. 
         [0029]    If a positive result is indicated on the test, the device with urine sample inside is sent to a laboratory for final confirmation. 
         [0030]    It should be apparent to those skilled in the art, that while the invention described herein, has been described in terms of a urinalysis screening device, or urinalysis screening test kit, that the same physical device can be use for screening other fluid materials where the fluid can be exposed to reactive strips that indicate whether or not certain substances are contained in the specimen being tested. The above described embodiments are simply illustrative of those embodiments that could be created by one skilled in the art without departing from the spirit and scope of the invention described herein.