Patent Publication Number: US-2006013738-A1

Title: Oral fluid collector with integrated drug screening system

Description:
BACKGROUND OF THE INVENTION  
      The present invention was originally disclosed in U.S. provisional patent application Ser. No. 60/588,430 filed on Jul. 16, 2004, and priority is claimed to the provisional patent application.  
      The present invention relates generally to the field of drug screening and more specifically to drug screens that test oral fluid.  
      Drug screening tests are well known in the personnel offices around the world. Employers commonly require tests for drugs of abuse, such as cocaine and heroin, and these tests have become an ordinary part of a job application. In the sports world, it is also common to test athletes for performance enhancing drugs such as certain steroids. Many drug screen tests include dipsticks that have been treated with chemicals so that they react to by-products of specific drugs. When the treated sites are exposed to a sample fluid from a job applicant or athlete, the dipsticks can provide almost immediate onsite testing. Other drug screens use test cards, which are cards that have had multiple sites on the card chemically treated so that multiple drugs can be tested for simultaneously. Test cards are used in the same manner as dipsticks, i.e., testing is conducted by exposing the card to a fluid sample, waiting a specified period of time and then reading the indication sites on the card.  
      In a traditional drug screen test, a sample provider deposits a urine sample into a collection cup, places a lid on the cup and then places a piece of tape over the lid so that the tape extends down over the lid and onto the cup. This piece of tape is intended to insure that no other substance is added to the urine sample prior to testing. The sample provider then hands the sealed collection cup to a test administrator. In order to gain access to the urine sample, the test administrator must break the seal that secures the lid to the top of the collection cup. At this point it is possible for other substances to fall, accidentally or otherwise, into the collection cup and taint the sample. The addition of foreign substances to a collected sample usually causes invalid test results and requires re-testing.  
      What is needed in the field is a self-contained collection and testing device that does not require exposure of the sample in order to test the sample. The ideal testing device would also test on a saliva sample, or oral fluid, so that a private bathroom is not required for collection of the sample.  
     SUMMARY OF THE INVENTION  
      A device that is adapted for partial insertion into a test subject&#39;s mouth, wherein the device efficiently collects oral fluid from the test subject and automatically begins a testing process on the collected oral fluid. The collection and testing device comprises a handle, a collection swab, a strip of flow assisting material and a shield. The handle substantially defines the length of the device, and has a closed end and an open end. At least one test strip is housed within the interior of the handle. The collection swab is attached to the open end of the handle and held in place by a swab support. The flow assisting material connects the collection swab to the at least one test strip and aids in the flow of the collected oral fluid to the at least one test strip. The shield is attached to the open end of the handle and at least partially extends over the collection swab. The shield is designed to prevent damage and tampering to the flow assisting material and the at least one test strip.  
      A security cap is provided for covering the collection swab after the collection process. When the cap is in place over the collection swab, it locks onto the handle and cannot be removed without breaking the locking mechanism. The cap includes an espressor plate that at least partially compresses the collection swab when the cap is placed in the locked position. The cap also includes a confirmation reservoir that receives a small amount of the oral fluid from the at least partially compressed collection swab when the cap is placed in the locked position. The confirmation reservoir includes a confirmation seal, such as a confirmation plug, that must be broken in order to remove the small amount of oral fluid from the confirmation reservoir.  
      The at least one test strip can be used to indicate use of drugs of abuse, including cocaine, heroin and amphetamines, by the test subject. The test strip(s) can also be used to indicate other conditions, such as pregnancy. The handle is preferably made of a clear material so that the at least one test strip is visible through the handle.  
      It is an object of the present invention to provide a device that both collects and tests an oral fluid sample from a test subject.  
      It is another object of the invention to house the test strips in the handle of the device so that a slim and easy to use testing device is created.  
      It is a further object of the present invention to prevent tampering with the test strips and provide a confirmation sample from the collected oral fluid. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
      The invention of the present application will be described in detail with reference to the accompanying drawings, given only by way of example, in which:  
       FIG. 1  ( a ) shows a side view of the preferred embodiment;  
       FIG. 1  ( b ) shows a side view of the cap for the preferred embodiment;  
       FIG. 2  shows a top view of the preferred embodiment; and,  
       FIG. 3  shows a top view of an alternative embodiment. 
    
    
     DETAILED DESCRIPTION OF THE INVENTION  
       FIG. 1 ( a ) shows a side view of the preferred embodiment  100  of the present oral fluid collector with integrated drug screening system. The device comprises a collection swab  115  made of absorbent material that when placed in the mouth will saturate itself with oral fluid, or saliva, from the test subject&#39;s mouth. Test strip  110 , which is capable of indicating the presence of one or more particular substances or metabolites that may be present in the saliva, is in fluid connection with the collection swab  115 . Each particular substance or metabolite that is tested for is associated with either use of a particular drug or existence of a particular condition, such as being pregnant. Such test strips are well known in the art and commercially available. The collection swab  115  is in fluid connection with the test strip  110  via a flow guide  120 , which assists in the flow of the oral fluid from the swab  115  to the test strip  110 . After the swab  115  is saturated, the collected oral fluid is drawn to the test strip  110  via the flow guide  120  and the testing process automatically begins. A protective shield  125  covers the flow guide  120  and the exposed portion of the test strip  110 . The shield  125  protects and prevents tampering with the flow guide  120  and the test strip  110 . The housing  105  of the present device provides a protective clear covering for the test strip  110  and also prevents damage and tampering with the test strip  110 . The housing  105  also doubles as a handle, which allows for a slim design and assists the test subject in holding the device during the collection process. The swab support  130  is a piece of plastic that attaches the swab to the housing  105 . Lock clasp  135  is attached to the housing  105  and is the female portion of a locking mechanism that is adapted to permanently hold a male portion, which is located in the cap.  
       FIG. 1 ( b ) shows the cap  140  for the preferred embodiment  100  of the present collection and testing device. After approximately three minutes of collection time, the cap  140  is placed over the swab  115  and the shield  125 . The cap  140  includes the male portion  165  of a locking mechanism that locks the cap  140  to the female portion  135  on the housing  105 . In the preferred embodiment, the locking mechanism cannot be released once the cap  140  is in the locked position. And, the only way to remove the cap is by breaking the locking mechanism. This allows the locking mechanism to be a simple slip-lock mechanism, which is used in slip-lock handcuffs, also called plastic strap handcuff. An espressor plate  155  within the cap  140  compresses the swab  115  when the cap is placed in the locked position. This compression causes a small amount of the oral fluid in the swab  115  to be forced into a confirmation reservoir  150  located in the far end of the cap  140 . The espressor plate  155  includes one or more one way flow valves  160  that trap the small sample of oral fluid in the confirmation reservoir  155 . A confirmation plug  170  is provided within the confirmation reservoir  155  for removal of the confirmation sample, if confirmation is required. In the preferred embodiment, the confirmation plug  170  must be broken off in order to gain access to the confirmation sample. A security seal such as foil tape may also be placed over the cap  140  and housing  105  immediately after the cap is locked in place, to add another layer of security.  
       FIG. 2  shows a top view of the preferred embodiment  100 . In this view the second test strip  200  is visible. The tops of both test strips  110  and  200 , which includes the results section of the test strips, are visible through the top of the housing  105 . So reading the results of each strip is as simple as looking at the top of the device. In the preferred embodiment  100 , the test strips  110  and  200  are manufactured to detect the test subject&#39;s use of cocaine, amphetamines, THC, opiates, or PCP. In alternative embodiments, other drugs of abuse can be tested for and at least one section of a test strip detects contaminants in the sample that are intended to interfere with the testing process. In other embodiments, the test strips can be used to indicate whether or not a woman is pregnant and also be used to indicate an illness or other condition. A results guide may be provided on the housing  105  of the present device, on a label for example, to aid an administrator in reading the results of the test. The protective shield  125  is preferably made of a flexible material so that the shield does not cause any damage to the test subject&#39;s teeth when the device is inserted in the mouth of the test subject. Both female portions  135  and  205  of the locking mechanism for securing the cap  140  to the housing  105  are also shown in  FIG. 2 .  
       FIG. 3  is the top view of an alternate embodiment  300 , which includes a privacy label  305  to cover the test strips. The privacy label can be an adhesive backed label, which is applied to the top of the housing  105 . The label may also contain a viewing window that allows viewing of the portions of the test strips that are in contact with the swab  115  to verify adequate saturation. At an appropriate time, the label  305  or a portion of the label can be removed by an administrator to allow viewing of the test result section of the test strips.  
      The foregoing description of the specific embodiments will so fully reveal the general nature of the invention that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept. Therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology of terminology employed herein is for the purpose of description and not of limitation.