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.
A device that is adapted for partial insertion into a test subject'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.
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:
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.
Number | Date | Country | |
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60588430 | Jul 2004 | US |