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12/14/06 - USPTO Class 436 |  68 views | #20060281189 | Prev - Next | About this Page  436 rss/xml feed  monitor keywords

Diagnostic detection device and method

USPTO Application #: 20060281189
Title: Diagnostic detection device and method
Abstract: The present invention relates to a diagnostic test kit and method for detecting the presence of certain metabolic by-products in human urine. The kit includes a test strip with an exposed face side containing chemical reagents which react in the presence of selected metabolic by-products. The reverse side of the test strip has an adhesive backing which allows the strip to be mounted in the interior of a commode bowl, initially above the water level. Flushing the commode causes the water level to rise and contact the chemical reagents. The reaction can be visually observed by removing the test strip from within the commode bowl. (end of abstract)



Agent: Whitaker, Chalk, Swindle & Sawyer, LLP - Fort Worth, TX, US
Inventor: Jimmy C. Minter
USPTO Applicaton #: 20060281189 - Class: 436169000 (USPTO)

Related Patent Categories: Chemistry: Analytical And Immunological Testing, Optical Result, With Reagent In Absorbent Or Bibulous Substrate

Diagnostic detection device and method description/claims


The Patent Description & Claims data below is from USPTO Patent Application 20060281189, Diagnostic detection device and method.

Brief Patent Description - Full Patent Description - Patent Application Claims
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BACKGROUND ART

[0001] 1. Field of the Invention

[0002] The present invention relates generally to assay/detection devices for detecting the presence of analyte in a field sample and, more specifically to an assay/detection device and method for detecting certain human metabolic by-products in toilet or urinal effluent.

[0003] 2. Description of Related Art

[0004] Inmunochromatographic assays, also called lateral flow tests or simply strip tests, are well known in the relevant arts. They are a logical extension of the technology used in latex agglutination tests, which have been available since the 1950's. The benefits of immunochromatographic tests include the fact that they are available in a user-friendly format, that only a short time is needed to obtain a result, that they exhibit long-term stability over a wide range of climates and that they are relatively inexpensive to manufacture.

[0005] These features make strip tests ideal for applications such as home testing, rapid point of care testing, and testing in the field for various environmental and agricultural analytes. In addition, they provide reliable testing that might not otherwise be available to third world countries.

[0006] The principle utilized in these tests is straightforward. Basically, any ligand that can be bound to a visually detectable solid support, such as dyed microspheres, can be tested for qualitatively, and in many cases even semi-quantitatively.

[0007] Immunochromatographic assays of the above type typically utilize a membrane as a solid support in a dipstick or flow-through device. These devices are available for drugs of abuse (cocaine, cannabinoid, amphetamines, opiates, PCP), pregnancy and fertility and infectious disease (chlamydia, Strep A, infectious mononucleosis, etc.). Some of the more common lateral flow tests currently on the market are tests for pregnancy, Strep throat, and Chlamydia. These are examples of conditions for which a quantitative assay is not necessary. The usual packaging for such assays is a membrane, typically cellulose, enclosed in a plastic holder. The device is then typically further packaged singly or in bulk in a sealed foil or plastic pouch which acts as an environmental control.

[0008] The plastic holder keeps the membrane in a suitable configuration in order to ensure correct functioning of the entire device. The usual test procedure involves opening the outer packaging and removal of the plastic device, followed by application of a sample through a sample window by dipping the device into the sample or by dropping the sample onto the sample window. After waiting the recommended amount of time, the results can be checked by checking the sample window for a positive or negative result. The result is typically indicated by a change in color of the test strip.

[0009] In the case of human metabolic by-products, the foregoing procedure assumes that a sample of urine is available for testing. In some cases, it may be advantageous to collect a sample or carry out a diagnostic test of urine without the knowledge of the subject being tested. Uses for this system would provide a screening or monitoring system for parents, counselors, coaches or other interested individuals.

[0010] There exists a need, therefore, for a diagnostic detection device and method which is inexpensive to manufacture, which provides at least a qualitative indication of the presence of a specific analyte and which can be administered in a relatively unobtrusive fashion.

[0011] There exists a need for such a diagnostic detection device which can be mounted quickly and easily within a commode or urinal, which device will provide an indication of the presence of a specific analyte upon flushing the commode or urinal.

[0012] There exists a need for such a device and method which can be used to test for the presence of the metabolic by-products of controlled substances including tetrahydrocannabinol, cocaine, opiates, barbiturates, amphetamine and methamphetamine.

SUMMARY OF THE INVENTION

[0013] The foregoing needs are met by the method and device of the present invention. The method of the invention can be used for detecting metabolic by-products of drug use in commode/urinal effluent. A test strip is mounted, for example, within a commode. The commode has a bowl with a bowl interior, the interior being partly filled to a water line with flush water. The test strip is mounted at a selected location within the bowl which is initially above the water line of the flush water, the test strip having applied thereto at least one diagnostic reagent which is activated by flush water containing urine. The test strip is removed after the commode has been flushed by a user and visually examined to determine if the diagnostic reagent has been activated by contact with the urine in the flush water to give a positive indication of the presence of the analyte in question.

[0014] Preferably, the test strip is comprised of a base strip having a planar adhesive face and an opposite planar exposed face, the exposed face having the chemical reagent applied thereto which is activated by flush water containing urine. The adhesive face allows the strip to be mounted within a commode or urinal in an unobtrusive fashion which would not normally be easily observed.

[0015] Preferably, a plurality of diagnostic reagents are applied to the exposed face of the test strip and the exposed face of the strip is at least partly encapsulated with a synthetic polymeric cover layer. A suitable cover layer can be formed of a polyolefin, such as polyethylene. In one embodiment of the invention, the stip is completely encapsulated except for and end opening of the cover layer. The encapsulation serves to prevent the diagnostic chemicals from being washed over and removed or overly diluted when the commode is flushed. A fabric strip can also be mounted on a selected face of the test strip, the fabric strip serving to wick flush water into contact with the diagnostic chemicals present on the exposed face of the test strip when the commode is flushed.

[0016] The test strip can also be packaged so that it is initially sealed within a pouch which also contains an initially encapsulated foaming agent which foams in the presence of urine. The foaming agent encapsulation is broken and the foaming agent is added to the flush water initially contained in the commode bowl prior to flushing. Suitable foaming agents can comprise, for example, sodium hypochlorite solution and calcium hypochlorite powder. Additional facilitating agents, such as a suitable surfactant, can also be included in the packaging.

[0017] Additional objects, features and advantages will be apparent in the written description which follows.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] FIG. 1 is a perspective view of a household commode having a test strip of the invention mounted therein, the test strip being indicated in dotted lines;

[0019] FIG. 2 is front planar view of a test strip of the invention showing the location of the chemical reagents thereon;

[0020] FIG. 3 is simplified, cross-sectional view of the test strip of FIG. 2;

[0021] FIG. 4 is a front view of a test strip of the invention enclosed in a packaging pouch; and

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Previous Patent Application:
Analyte detection devices and methods with hematocrit/volume correction and feedback control
Next Patent Application:
Ratiometric test strip and method
Industry Class:
Chemistry: analytical and immunological testing

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