Abstract:
A multiple-chamber container for sampling, storing and preserving for later testing a sample. A swab having a foam tip is used to collect a sample (the sample must have some liquid component, e.g., saliva, urine, blood, etc.). After the foam tip is used to collect a specimen, the swab is inserted into the container where the foam tip is compressed and a portion of the specimen that was sampled is diverted into each chamber. The swab is locked into the container thereby sealing the specimen inside. At least one test strip is positioned inside one of the chambers to test the sample. The sample in the other chamber(s) are separated and can be stored for a period of time. A preservative may be used to help keep the specimen during storage.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     The present application claims the benefit under any applicable U.S. statute to U.S. Provisional Application No. 60/327,227 filed Oct. 5, 2001, titled APPARATUS FOR SAMPLING, STORING AND TESTING A SPECIMEN. 
     This application incorporates by reference U.S. Provisional Appln. No. 60/327,227, as if fully set forth herein. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates generally to a drug screening apparatus and, more specifically, to a self-contained, tamper-proof system for testing, storing and screening for drugs and drug metabolites. The invention is not limited to screening for drugs. 
     BRIEF DESCRIPTION OF THE PRIOR ART 
     More businesses are requiring new employees to undergo pre-employment drug testing before hiring. Also, post-accident drug testing is almost routine, especially when flammable or hazardous waste hauling is involved, or where the safety of a large number of people are concerned (e.g., oil tanker captain, truck driver or high-speed train engineer). A saliva sample may be obtained and sent to a lab for testing. In most cases the sample will degrade within a short period of time unless the sample is treated. There are companies that offer a device to store and transfer the saliva sample until a lab can perform specific test. There are also saliva test available to perform rapid test, thus providing immediate results. If the test turns up positive, the specimen must then be sent to a more sophisticated, usually remotely located, testing lab. Unfortunately, the specimen will not provide accurate results if too much time passes. This alone, is one reason that a urine sample is often the preferred method for testing for Drugs and Drug Metabolites. There are companies that developed preservatives that may be used to store and preserve salvia samples. Such devices provide a swab to collect a sample and a container, which is pre-filled with a preservative that is used to treat and store the sample during shipment to a lab where the sample will then be tested. 
     SUMMARY OF THE INVENTION 
     The present invention is a self-contained, tamper-proof screening, testing and storage apparatus. The present invention also splits the sample and if desired, the untested portion of the sample may be treated, thus preserving the sample for future testing. The present invention consists of a divided container, wherein one side of the container holds rapid test strips and the other side may hold a preservative (if desired), a bottom plug that snaps and locks onto the bottom end of the container, a top cover that snaps and locks onto the top end of the container, a stopper that seals the container prior to use and a sampling swab that collects the sample and eventually seals and activates the apparatus. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The foregoing summary, as well as the following detailed description may be better understood when read in conjunction with the accompanying drawings, which are incorporated in and form a part of the specification. The drawings serve to explain the principles of the invention and illustrate embodiments of the present invention that are preferred at the time the application was filed. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown. 
       The accompanying drawings, which are incorporated in and form a part of the specification, illustrate the embodiments of the present invention and, together with the following description, serve to explain the principles of the invention. For the purpose of illustrating the invention, there are shown in the drawings embodiments which are presently preferred, it being understood, however, that the invention is not limited to the specific instrumentality or the precise arrangement of elements or process steps disclosed. 
       In the drawings: 
       In the drawings: 
         FIG. 1  is a partial top view of the self-contained, tamper-proof screening, testing and storage apparatus without the top cover and sample swab incorporated. 
         FIG. 2  is a top view of the top cover of the self-contained, tamper-proof screening, testing and storage apparatus shown in  FIG. 1 . 
         FIG. 3  is a partial top view of the bottom plug of the self-contained, tamper-proof screening, testing and storage apparatus shown in  FIG. 1 . 
         FIG. 4  is a perspective view of the sampling swab of the self-contained, tamper-proof screening, testing and storage apparatus shown in  FIG. 1 . 
         FIG. 5  is a cross sectional view of the top cover shown in  FIG. 2  and the stopper for sealing the self-contained, tamper-proof screening, testing and storage apparatus shown in  FIG. 1 . 
         FIG. 6  is partial bottom view of the divided container that shows the hollow center section of the divided container and shows the sleeves that hold the test strips for the self-contained, tamper-proof screening, testing and storage apparatus shown in  FIG. 1 . 
         FIG. 7  is a perspective view of the self-contained, tamper-proof screening, testing and storage apparatus shown in  FIG. 1  that also includes and incorporates the top cover and the sampling swab, respectively. 
         FIG. 8  represents an alternative shape/design of the self-contained, tamper-proof screening, testing and storage apparatus shown in  FIG. 1  and  FIG. 7 . 
         FIG. 9  is an exploded view of yet another embodiment of a testing, sample storage and screening apparatus. 
         FIG. 10A  is a perspective view of the testing, sample storage and screening apparatus of  FIG. 1  showing a stopper and a stopper/swab. 
         FIG. 10B  is an exploded view of the testing, sample storage and screening apparatus of  FIG. 10A . 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     In describing a preferred embodiment of the invention, specific terminology will be selected for the sake of clarity. However, the invention is not intended to be limited to the specific terms so selected, and it is to be understood that each specific term includes all technical equivalents that operate in a similar manner to accomplish a similar purpose. 
     Preferred embodiments of the present invention will now be described in detail with reference to the accompanying drawings in which an apparatus for testing saliva in order to screen for drugs in accordance with the present invention is generally indicated at  10 . 
     Referring now to  FIG. 1 , an apparatus  10  for screening for the presence of drugs in accordance with the present invention is shown. The apparatus  10  consists of a divided container  18  having exterior walls  26 . The apparatus has a top end  98  and a bottom end  99 . The divided container  18  has a tubular compartment  15  that is positioned proximately in the center of the divided container  18  and has divider walls  11  that extend radially outward from the tubular compartment  15  to the outer walls of the container. The divider walls  11  separate the apparatus  10  into two separate chambers, a first chamber  17  and a second chamber  21 , respectively. 
     At the lower end of the hollow tubular compartment  15  there are two windows  29  that open into each of the divided chambers  17  and  21 . Also, at the lower end of container  18  there is a bottom plug  30  that snaps into the bottom of container  18 . The bottom plug  30  seals the entire lower end of the divided container and provides a seal between the divider walls  11  and bottom plug grooves  23 . The bottom plug  30  also has a footer  33  that extends upward from bottom plug  30  into the lower end of the hollow section  15  of the container  18 . 
     Referring now to  FIGS. 10A and 10B , the footer  33  of the bottom plug  30  extends far enough into the tubular compartment  15  and has a diameter that provides a seal between the openings of the container with the bottom plug, although the footer does not provide a seal the entire length of the footer  33 . The footer  33  does not extend upward far enough to seal the windows  29  that open onto the separate chambers  17  and  21 . At the top of footer  29  the diameter is significantly small enough to prevent a seal between the footer  29  and the hollow interior of the tubular section  15 . This area is referred to as the footer-locking bead  39 . 
     The bottom plug also has tapered surfaces  27  (See  FIG. 10B ) on both sides for controlling the direction of the flow of the specimen within both chambers  17  and  21 . The bottom plug also has a small reservoir  37  in chamber  21 . This reservoir will be used to extract small amounts of specimen when and if a remote lab may need to access and remove a sample of the specimen. This will be better understood as we describe the other drawings in more detail. 
     In chamber  17  of apparatus  10  there are narrow sleeves  13  that extend from the top  98  of the container  18  to the bottom  99  of container  18 . The sleeves  13  hold test strips. At the lower end of the divided container the sleeves  13  have small openings  35  that allow the test strips to be exposed to the sample. 
     Referring now to  FIG. 2 , the top view of the top cover  20  of the apparatus described in  FIG. 1 . The top cover  20  snaps and locks onto the divided container  18 . The locking mechanism in  FIG. 1 ,  19  provides a seal and locking means between the outer edge of the top cover  20  and the interior edge  19  of container  18 . There are also sealing means (via friction fit) between the top cover  20  under surface and the container  18  described in  FIG. 1 . 
     In  FIG. 1  the top surface of the divider wall  11  will be sealed with the under surface of the top cover  45 . The top surface of the sleeves  13  of container  18  will be sealed with the under surface  43  of the top cover  20  and the top cover hollow center  41  will seal around the hollow section  15  of container  18  by the top cover seal  48 . 
     The top cover  20  also has a small nipple  47  that extends upward so that it is perfectly aligned with the bottom plug reservoir  37  shown in  FIGS. 1 ,  10 A and  10 B. The purpose will be understood later in this description. 
     Referring now to  FIG. 3 , a partial top view of the bottom plug  30  of the apparatus described in  FIG. 1 . Bottom plug  30  seals the lower end of the divided container  18 . Grooves  23  engage and seal the lower end of the divider walls  11  of container  18 . The sealing and locking bead  31  of bottom plug  30  engages seals and locks onto to lower end of the divided container  18 . The footer  33  of the bottom plug  30  engages and seals the lower section of the bottom plug  30 . Note that the footer  33  does not entirely seal the windows  29  of the hollow section  15  of the divided container. Also, at the top of footer  33  the diameter is significantly small enough to prevent a seal between the footer  33  and the hollow interior of the tubular compartment  15 . This area is referred to as the footer-locking bead  39 . This footer-locking bead  39  will be described in  FIG. 4 . Bottom plug  30  has a reservoir  37  in chamber  21  of divided container  18 . The reservoir  37  is aligned directly under the top cover  20  extended nipple  47 . The extended nipple  47  described in  FIG. 2  will provide tamper evident means to access the interior of chamber  21  for remote lab test verification purposes. Extended nipple  47  may be permanently cut off, thus providing access to chamber  21  of the divided container  18 . Bottom plug  30  has small conduits  49  to control, focus and provide the maximum amount of sample to the openings  35  in the lower part of the sleeves  13  of container  18 . This is especially important when there may be a small amount of a sample to be tested. Tapered walls  27  of the bottom plug  30  also control the flow of the sample specimen within both chambers  17  and  21  respectively. 
     Referring now to  FIG. 4 , a perspective view of the specimen sample swab  40  for use with the apparatus described in  FIG. 1 . Swab  40  is comprised of a gripping area  51 , a tamper proof lock  53  and a shaft  55 . Swab  40  is used to extract a sample of saliva from one&#39;s mouth by placing the absorbent pad  61  into the mouth of the individual being tested. Swab  40  has a housing  57  that holds the absorbent pad  61  during use. Housing  57  has lock and seal means  59  that work I conjunction with the footer-locking bead  39  of bottom plug  30 , previously described in the apparatus of  FIG. 1 . 
     Referring now to  FIG. 5 , a cross-sectional view of the top cover shown in  FIG. 2  and the stopper for sealing the self-contained, tamper-proof screening, testing and storage apparatus shown in  FIG. 1 . Stopper  50  has sealing means  69  that work in conjunction with the footer-locking bead  39  of bottom plug  30 , previously described in the apparatus of  FIG. 1 . Note: The stopper seals the passage way windows  29  between the interior of hollow section  15  of divided container  18  and seals the footer-locking bead  39  of bottom plug  30 , previously described in the apparatus of  FIG. 1 , although the stopper does not permanently lock in place. Stopper  50  is inserted through the top cover opening  41 , prior to use. Stopper  50  incorporates pull-tab  67  that are used to remove stopper  50  from the apparatus  10 . 
     Referring now to  FIG. 6 , a partial bottom view of the divided container  18  that shows the hollow center section  15  of the divided container  18  and shows the sleeves  13  that hold the test strips for the self-contained, tamper-proof screening, testing and storage apparatus  10  shown in  FIG. 1 . (Although  FIGS. 1 and 2  show three test-strip channels for holding test strips,  FIG. 6  illustrates an embodiment with only two test-strip channels. A person skilled in the art, after reading this description, would understand that the number of test strip channels depends on the type of strips used and the number of tests/drugs for which the apparatus will be used.) 
     Referring now to  FIG. 7 , an apparatus  10  for screening for drugs is shown. Specific features of the subject apparatus  10  will become more apparent through the explanation of a screening for drug metabolites in a saliva sample. The test subject places specimen swab absorbent pad  61  into ones mouth for a short period of time. Absorbent pad  61  consists of a hydrophilic membrane, which enhances the collecting of a saliva specimen from the test subject. After the absorbent pad  61  is saturated with saliva the specimen swab  40  is pushed into the opening of the top cover  20  which is attached to the divided container  18  of apparatus  10 . Eventually the bottom plug footer  33  will contact the absorbent pad  61  causing the absorbent pad  61  to compress, thus forcing the saliva specimen through both windows  29  which lead to both, chambers  17  and  21  (shown in  FIG. 1 ) respectively. The housing  57  of specimen swab  40  prevents excess saliva from moving upward towards the specimen swab shaft  55 . When the specimen swab  40  is fully compressed the locking bead  59  of housing  57  engages, locks and seals within the footer-looking bead  39  of the bottom plug  30 . At this time the passage way between chambers  17  and  21  (shown in  FIG. 1 ) are completely seal off from one another thus, the windows  29  of the divided container  18  are sealed off by housing  57  of the specimen swab  40  and the footer-locking bead  39  is sealed with the locking bead  59  of the specimen swab  40 . Simultaneous, the specimen swab handle  51  engages and locks onto the top cover  20  by means,  48  of top cover and  53  of specimen swab handle thus, providing a permanent tamper proof lock and seal. 
     As the saliva specimen enters chambers  17  and  21  (shown in  FIG. 1 ) the tapered walls  27  of bottom plug  30  control the flow of the specimen. Also, conduits  49  of bottom plug  30  provide a passageway directly towards the openings  35  in the test strip sleeves  13  of chamber  17  of the divided container  18  thus, maximizing the amount of specimen that can be used for activating the test strips. Saliva will also flow into chamber  21  which may mix with a preservative, if desired, or just remain isolated for purposes of future testing (confirmation) by a remote lab. If a test result is positive the entire apparatus  10  may be mailed to a remote laboratory for verification. The remote lab technician must cut off the extended nipple  47  of top cover  20  in order to access the stored unadulterated sample in chamber  21  of the divided container  18 . Reservoir  37  of bottom plug  30  is positioned directly below extended nipple  47  of the top cover  20 . A small sample may be removed with a pipette. 
     Referring now to  FIG. 8 , an alternative shape/design of the self-contained, tamper-proof screening, testing and storage apparatus  10  shown in  FIGS. 1 and 7 . Apparatus  10  has a divided container  18 , with test strip sleeves  13  and a specimen swab  40 . 
     Referring now to  FIG. 9 , an exploded view of yet another embodiment of a testing, sample storage and screening apparatus. Note: This embodiment incorporates both the test strips, the sleeves that hold the test strips and the absorbent pad within a single holder. The cover incorporates a flushing agent or preservative that is accessed when the cover is snapped onto the single holder. 
     Although this invention has been described and illustrated by reference to specific embodiments, it will be apparent to those skilled in the art that various changes and modifications may be made which clearly fall within the scope of this invention. The present invention is intended to be protected broadly within the spirit and scope of the appended claims.