Chemistry: analytical and immunological testing – Involving an insoluble carrier for immobilizing immunochemicals
Reexamination Certificate
1999-04-21
2002-04-16
Nguyen, Bao-Thuy L. (Department: 1641)
Chemistry: analytical and immunological testing
Involving an insoluble carrier for immobilizing immunochemicals
C422S051000, C422S051000, C422S051000, C422S051000, C422S067000, C422S062000, C435S287700, C435S287800, C435S288100, C435S969000, C435S970000, C435S805000, C436S823000, C436S810000
Reexamination Certificate
active
06372515
ABSTRACT:
TECHNICAL FIELD
The present invention relates to the collection and testing of fluid samples for drugs of abuse, more particularly, to a multiple drug test card for indicating visually the presence of particular drugs of abuse in urine and a process for making the test card.
BACKGROUND ART
The increased availability and use of drugs of abuse by the general population has caused employers, governmental agencies, sports groups and other organizations to utilize drug screening both as a condition of employment and in order to maintain safety in the work place. Typical drug screening tests are performed for the purpose of quickly identifying on a qualitative basis the presence of drugs in a body fluid which may be urine. A complete analysis of the sample may then be carried out in a laboratory only if the preliminary screening results are positive. More and more such drug screenings are taking place on site or the work place and are generally carried out by testing personnel who are not technically trained, such as laboratory technicians. It is thus important that the drug screening procedure is simple but yet reliable. Further, the test apparatus must be such so as to enable the testing personnel to avoid all contact with the fluid specimen which is being tested.
Various forms of devices have been proposed for the collection and taking of body fluids, such as urine, which have proved to be cumbersome in operation since they involve a number of separate steps. Initially, the sample was collected and several additional steps were then required to transfer the urine sample to an analysis device. This multiple step procedure required the manual handling of the specimen through various devices and the use of such transfer devices inevitably caused spills which may result in contamination to the tester and surroundings. In addition, nontechnical personnel who perform the screening tests on urine samples objected to coming into any kind of contact with the urine sample and even the handling of the sample itself.
Many of the known testing devices were rather complex in that they included a container for the specimen, and, subsequently it was necessary to transfer the specimen or at least a portion thereof to another compartment of the container in order to perform the test. This transfer of the specimen required vigorous shaking of the container or turning the container upside down in order to cause the flow of the specimen into a test compartment. It was therefore necessary to make the containers leak proof under such condition and the result was a complicated and expensive container structure.
Further, the containers incorporated the structure by means of which reagent strips were mounted in a test compartment of the container and which structure also enabled the fluid sample to flow into the test compartment into contact with the reagent strips. Such a mounting of the reagent strips further resulted in complicating the structure of the container since it was also necessary that provision be made to view the reagent strips from outside of the container. This was generally achieved by providing a transparent window or some other mounting of the reagent strips so as to be visible to testing personnel.
DISCLOSURE OF INVENTION
It is therefore the principal object of the present invention to provide a novel and improved device for the testing of body fluid samples, particularly urine, for several drugs of abuse at the same time.
It is a further object of the present invention to provide a novel and improved test card having a plurality of immunoassay test strips on one or both sides thereof with each strip being responsive to a particular drug of abuse and having a visual endpoint to indicate the presence or absence of a particular drug.
It is additional object of the present invention to provide a simple and effective process for making such a drug test card.
The objects of the present invention are achieved and the disadvantages of the prior art are eliminated by the drug abuse test device according to the present invention which may comprise a cup-like transparent container for retaining a urine sample to be tested. The open top of the container has a closure cover or cap and there is a diametrical slit in the cap. The slit is of such a size to accommodate a test card which has a plurality of immunoassay test strips mounted thereon in parallel on one side and each test strip is responsive to a particular drug of abuse. The test card is insertable through the slit so as to have one end immersed in the urine sample to a predetermined depth whereby the visual results of each test strip can be seen through the transparent wall of the container without removing the test card from the container so as to indicate the presence or absence of a particular drug of abuse in the urine sample. If the sample should test “positive” to indicate the presence of a drug in the urine, it is then necessary to send the sample to a certified laboratory for confirmatory testing. For this purpose, a second closure cap which is solid, i.e., not slit, is provided which may be threaded into the open end of the cup-like container. The test card is removed from the container, the solid closure cap is threaded on to close the container and the container is then ready for shipment to a laboratory.
As described above, the test kit includes a drug abuse test device for collecting and testing a urine sample. This test device comprises a cup-like container having a substantially transparent wall and having an open top upon which is threaded a closure cover provided with a slit therein to receive a test card. A solid second closure cap which threads over the outer end of the cup-like container is provided to seal the container to permit the safe shipment of a fluid sample therein.
The test kit also includes a screen test card for drugs of abuse which may comprise a thin flat member having the size and shape of a business card. A plurality of immunoassay test strips are fastened side by side in parallel on one or both sides of the test card within the outline of the card. Each test strip is reactive to provide a visual indication in response to a particular drug of abuse. The test card thus provides for the simultaneous detection of multiple analytes.
REFERENCES:
patent: 4518565 (1985-05-01), Boger et al.
patent: 5238652 (1993-08-01), Sun et al.
patent: 5441698 (1995-08-01), Norell
patent: 5500375 (1996-03-01), Lee-Own et al.
patent: 5712172 (1998-01-01), Huang et al.
Casterlin Douglas
Cipkowski Stan
Wells Henry J.
American Bio Medica Corporation
Jaskiewicz Edmund M.
Nguyen Bao-Thuy L.
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