WO2000017636A1 - Alcohol concentration test system - Google Patents

Abstract

The assay test comprises three main parts, a base (16), a middle (20) and a top (21). The base includes a well (40), an absorbent material (42) and reaction means impregnated upon this thin sheet (14) for the detection of alcohol.

Description

ALCOHOL CONCENTRATION TEST SYSTEM

FIELD OF THE INVENTION

The present invention relates to an alcohol concentration assay test system, including compositions and methods for storing multiple alcohol concentration assay tests and compositions and methods for measuring the concentration of alcohol in a sample.

BACKGROUND OF THE INVENTION

Automobile crashes caused by individuals who are impaired by alcohol are a significant social and economic problem. Many individuals, some of whom may have had only a few drinks, drive impaired because they physically feel fine. Many of these drivers do not know that their bodies have absorbed enough alcohol to increase their risk of getting into a crash.

If impaired individuals had an easy way to check how much alcohol their bodies had absorbed (i.e., to determine their alcohol concentration) prior to operating a motor vehicle instead of relying on how they physically felt, many would change their decision to drive and crashes would be prevented. There is much need for an assay test (i.e., alcohol concentration test) that would allow impaired individuals to check their alcohol concentration. There are many devices that test individuals' alcohol concentration that are available in the marketplace today. However, many of these devices are too complex or expensive for use by individuals outside of a laboratory or clinical setting. Additionally, many individuals have an aversion to blood and urine testing and would not be willing to self- administer such assay tests. Inexpensive breath assay tests are available as a less invasive alternative to blood and urine based assay tests. However, inexpensive breath assay tests are much less accurate than blood-based assay tests, the standard for which all alcohol assay tests are compared, and many are difficult to use. Saliva alcohol concentration assay tests, which exhibit a strong, direct correlation to blood alcohol concentration assay tests, are an inexpensive and less invasive alternative to blood and urine-based assay tests and are proven to be accurate. However, saliva assay tests that adequately combine ease of use, small size, speed, accuracy, reliability, low cost, durability, and inteφretability, and that are designed for widespread distribution and use are unknown in the art. This is readily apparent from the lack of widespread use of such tests. Although some assay tests meet some of the desired characteristics, no assay test meets enough of the criteria to facilitate wide-spread use for self-detection of intoxication.

SUMMARY OF THE INVENTION The present invention relates to an alcohol concentration assay test system, including compositions and methods for storing multiple alcohol concentration assay tests and compositions and methods for measuring the concentration of alcohol in a sample. The present invention provides a system comprising a diagnostic device for analyzing saliva for the presence of ethanol, with the diagnostic device comprising: a solid support; a collection site attached to a first portion of the solid support, wherein the collection site is capable of collecting a saliva sample; a reaction means attached to a second portion of the solid support, wherein the reaction means produces a detectable signal in the presence of ethanol; wherein the solid support, collection site, and reaction means are contained within a single device. In some embodiments, the collection site and reaction means may be in contact with one another (e.g., an absorbent material layered onto or integrated with a reaction means). Thus, in some embodiments the first portion and second portion of the solid support may define partially or entirely overlapping regions of the solid support.

In some embodiments of the present invention, the diagnostic device comprises a thickness, a width, and a length, wherein the thickness is 1.5 millimeters or less, the length is 5 centimeters or less, and the width is 1.25 centimeters or less, although larger and smaller dimensions are also contemplated by the present invention. In other embodiments, the solid support comprises plastic. In yet other embodiments, the collection site comprises an absorbent material. In some preferred embodiments, the reaction means comprises one or more alcohol metabolizing enzymes. In other preferred embodiments, the reaction means comprises a biosensor. In some embodiments, the reaction means further comprises one or more competitors, wherein the one or more competitors are capable of preventing the reaction means from producing the detectable signal until the one or more competitors are substantially depleted or otherwise prevent the detectable signal from being substantially detectable unless a threshold concentration of alcohol is present in a sample (e.g., no substantially detectable signal unless a sample contains an alcohol concentration corresponding to a blood alcohol concentration of 0.04%). It is contemplated that, in some embodiments, multiple competitors are used, each with a different threshold level, such that the reaction means produce detectable signals at two or more particular concentrations of test samples. In some embodiments, the reaction further comprises one or more stabilizers (e.g., compounds that increase the shelf-life of the reaction means in response to moisture, light [e.g., ultra-violet light], air, and the like). In yet other embodiments, the reaction means comprises two or more reaction components, wherein the two or more reaction components of the reaction means are separated by one or more breakable barriers. In some embodiments, the reaction means is enclosed in a protective encasement.

In some embodiments of the present invention, the first and second portions of the solid support are separated by a hinge. In other embodiments, the first and second portions of the solid support are separated by a breakable barrier. In yet other embodiments, the collection site is slidingly attached to the solid support.

In some preferred embodiments, the system further comprises a protective encasement, wherein the diagnostic device is enclosed in the protective encasement. In some preferred embodiments of the present invention, the diagnostic device further comprises a second reaction means attached to a third portion of the solid support, wherein the second reaction means produces a second detectable signal, with the second detectable signal indicating a sufficient volume of the test sample (e.g., saliva sample). In some embodiments of the present invention, the system further comprises a delivery system, whereby the delivery system comprises one or more compartments capable of storing one or more of the diagnostic devices. In preferred embodiments, the delivery system comprises two or more compartments, each compartment accessible (e.g., independently accessible) to allow use of one or more alcohol concentration tests without exposing tests in other compartments. In some embodiments, the delivery system further comprises one or more protective encasements capable of enclosing the diagnostic devices in the one or more compartments. In yet other embodiments the delivery system further comprising one or more placards.

The present invention also provides a delivery system comprising one or more first packages comprising one or more compartments and a second package containing the one or more first packages. For example, in one embodiment the delivery system comprises one or more alcohol concentration assay tests, two or more first packages comprising one or more compartments, wherein the one or more alcohol concentration assay tests are contained in the first package; and a second package, wherein the two or more first packages are contained in the second package.

In a particularly preferred embodiment, alcohol concentration tests are contained in first packages wherein the first packages comprise a first wall and a second wall and wherein each wall comprises an interior heat-sealed protective layer (e.g., a plastic layer), a intermediate layer (e.g., a foil layer), and an outer layer (e.g., a paper layer). The first and second wall are contacted at the edges to form in interior opening in which the alcohol concentration test is enclosed (e.g., sealed). In some embodiments, the outer surface of each wall further comprises diagrams, text, or other written materials (e.g., instructions, warning, logo, etc.). The first packages are contained in second packages. In preferred embodiments, the second package is approximately the size and shape of a credit card. In one preferred embodiment, the second package is made of a first wall and a second wall, wherein the second wall is sealed to the first wall along three edges, forming an opening on one end of the second package. The first packages are insertable and removable through the opening. In particularly preferred embodiments, the first wall of the second package is transparent to allow visibility of the contents (e.g. , visibility of written materials on the first packages contained within the second package). In other preferred embodiments, the second package is made of plastic. In yet other preferred embodiments, the second package contains two or more first packages (e.g., to allow users to access alcohol concentration tests on more than one occasion).

In other embodiments, the second package comprises a first and second wall connected by a hinge along one edge of the first and second walls. Alcohol concentration tests are attached to the inner surface of the first wall (e.g., enclosed in a pouch contained on the inner surface of the first wall). When the hinge is closed, the alcohol concentration tests are enclosed between the first and second walls. When the hinge is opened, the alcohol concentration tests are accessible.

In yet another preferred embodiment, the delivery system further comprises a flat solid support and one or more first packages (each containing one or more alcohol concentration tests in one or more compartments) attached (e.g., glued) to the flat solid support. In a preferred embodiment, the first packages are attached to the solid support in such a manner that the alcohol concentration tests are accessible without removing the first package(s) from the solid support. The present invention also provides a delivery system for storing alcohol assay tests, comprising one or more (e.g., two or more) compartments capable of containing alcohol assay tests. In some preferred embodiments, the delivery system further comprises a plurality of protective encasements capable of enclosing the alcohol assay tests in the compartments. In other preferred embodiments, the delivery system comprises a thickness, a width, and a length, wherein the thickness is 2 millimeters or less, the length is 5.5 centimeters or less, and/or the width is 8.25 cm or less. In yet other preferred embodiments, the delivery system has a thickness less than 1 millimeter, a length less than 8.5 centimeters, and/or a width less than 5.5 cm. In yet other preferred embodiments, the delivery system is the approximate size and shape of a standard credit card. In yet other preferred embodiments, the delivery system further comprises one or more placards. In other embodiments, the delivery system is made of plastic.

The present invention further provides a delivery system for storing alcohol assay tests, comprising one or more (e.g., two or more) compartments and one or more alcohol assay tests, wherein the one or more alcohol assay tests are contained within the one or more compartments. In preferred embodiments, the delivery system comprises two or more compartments, each containing one or more alcohol concentration tests. In some preferred embodiments, the delivery system further comprises a plurality of protective encasements, wherein the protective encasements enclose the one or more alcohol assay tests in the compartments. In other preferred embodiments, the delivery system comprises a thickness, a width, and a length, wherein the thickness is 2 millimeters or less, the length is 5.5 centimeters or less, and/or the width is 8.25 cm or less. In yet other preferred embodiments, the delivery system has a thickness less than 1 millimeter, a length less than 8.5 centimeters, and/or a width less than 5.5 cm. In yet other preferred embodiments, the delivery system is the approximate size and shape of a standard credit card. In yet other preferred embodiments, the delivery system further comprises one or more placards. In other embodiments, the delivery system comprises plastic. DESCRIPTION OF THE FIGURES

Figure 1 shows a top view of an alcohol concentration assay test made with a hinge that allows one end of a test to be folded onto the other.

Figure 2 shows the three main components that make up the assay test in Figure 1.

Figure 3 shows a top view of a delivery system that stores multiple assay tests and is made with a hinge that allows the entire delivery system to be opened.

Figure 4 shows a top view of the delivery system in Figure 3 when closed.

Figure 5 shows an individual putting one end of an assay test from Figure 1 into their mouth.

Figure 6 shows how a hinge allows one end of an assay test from Figure 1 to be folded onto another.

Figure 7 shows a top view of an assay test from Figure 1 where one end has been folded onto the other. Figure 8 shows an assay test made with a hinge that allows two pieces from one end of an assay test to be folded around the other end.

Figure 9 shows an assay test made with a sliding mechanism that allows a portion from one end of an assay test to be slid around the other end.

Figure 10 shows an assay test similar to the assay test in Figure 1 but constructed of two main components instead of three.

Figure 11 shows a delivery system that stores multiple assay tests, and is made with five hinges that allow five compartments in the delivery system to be opened.

Figure 12a shows an assay test from Figure 1 and how it fits into a protective encasement. Figure 12b shows a delivery system that stores multiple assay tests and is made with multiple compartments that are each covered with a removable protective encasement.

Figure 13a shows an assay test similar to the assay test in Figure 8, but which comprises a secondary chamber containing additional reaction components.

Figure 13b shows an assay test similar to the assay test in Figure 9, but which comprises a secondary chamber containing additional reaction components.

Figure 13c shows an assay test similar to the assay test in Figure 1, but which comprises a secondary chamber containing additional reaction components. Figure 13d shows an assay test similar to the assay test in Figure 13c, but which comprises two main components instead of three.

Figure 13e shows the top view of an assay test similar to the assay test in Figure 13c except that two chambers containing additional reaction components are located on the opposite end of the assay test from the chamber containing additional reaction components in Figure 13c.

Figure 13f shows a side view of the assay test in Figure 13e.

Figure 14 shows one embodiment of the delivery systems of the present invention.

Figure 15 shows one embodiment of the delivery systems of the present invention. Figure 16 shows one embodiment of the delivery systems of the present invention.

GENERAL DESCRIPTION OF THE INVENTION

The present invention relates to an alcohol concentration assay test system, including compositions and methods for storing multiple alcohol concentration assay tests and compositions and methods for measuring the concentration of alcohol in a sample. In preferred embodiments, the present invention provides:

1) An assay test that is contained within a single device so that it is easy to use. In preferred embodiments, the assay test is also small, fast, accurate, reliable, inexpensive, easy to read and decipher, and durable; and

2) A delivery system that stores multiple assay tests so that the assay tests can be accessed on one or more occasions. In preferred embodiments, the delivery system makes assay tests both easy to carry and durable. In some preferred embodiments, the delivery system provides placards for instructions, warnings, labels, and other text or diagrams.

Preferred embodiments of the present invention provide tests and systems that facilitate wide-spread use of alcohol concentration tests by individuals. For example, to increase the number of impaired individuals that would use such an assay test and adhere to its results, the assay test should be contained within a single device and should be easy to use, small, fast, accurate, reliable, inexpensive, easy to read and decipher and durable. Thus, in some embodiments, the assay test of the present invention comprises a single device so that it is easy to use. Ease of use is necessary so that drinkers impaired by alcohol can easily determine if they are too drunk to drive. In preferred embodiments, the assay test is small so that it is easy to carry. In some preferred embodiments, the assay test works fast so people do not have to wait long to make their decisions to drive after drinking. In other preferred embodiments, the assay test is accurate so individuals can make decisions based on correct information. In yet other preferred embodiments, the assay test is reliable so people know when it is functioning properly. In some preferred embodiments, the assay test is inexpensive so that it can be afforded easily. In further preferred embodiments, the assay test's results are easy to read and decipher so that drinkers impaired by alcohol can determine easily if they are too drunk to drive. In still other preferred embodiments, the assay test is durable so that it can be handled easily without breaking or becoming damaged. Unlike the alcohol concentration detection devices known in the art, the assay tests of the present invention combine these desired features into a single, easy to use device that significantly facilitates self-detection and assessment of intoxication. The present invention further provides delivery systems that a) store multiple assay tests so that they can be accessed on one or more occasions (e.g., on one or more separate days, weeks, or months), b) in some embodiments, make assay tests durable and easy to access and carry, and c) in some other embodiments, provide placards for instructions, warnings, labels, and other text or diagrams. As mentioned above, the delivery system of the present invention stores multiple assay tests so that multiple assay tests can be accessed on a single occasion or on two or more distinct occasions. This flexibility is important for several reasons. For example, because individuals may use assay tests on separate occasions, the delivery system stores a sufficient quantity of tests to last an individual a period of days, weeks or months, thereby diminishing the need to continually replenish assay test supply. Additionally, because individuals may use more than one assay test on a given occasion, for example, to determine if their alcohol concentration has dropped over time, the delivery system stores multiple assay tests. In preferred embodiments of the present invention, the delivery system makes assay tests easy to carry so that individuals can easily and discreetly put the devices in their pockets, wallets, or purses for use in situations away from home. In other preferred embodiments, the delivery system ensures the durability of the assay tests so the assay tests do not break or spoil easily. In yet other preferred embodiment, the delivery system makes alcohol tests easy to access so that removal of the assay test from the delivery system can be conveniently accomplished, even by impaired individuals. In some preferred embodiments, the delivery system provides large placards so that instructions, labels, warnings, or other text or diagrams are easy to notice and read.

The present invention further contemplates assay tests and delivery systems that provide advantages for distribution of the tests and systems to individual consumers by one or more secondary parties (i.e., parties other than the consumer). For example, it is contemplated that the alcohol tests are provided to alcohol consumers by another party (e.g., a restaurant, bar, university, insurance company, etc.). In such embodiments, it is contemplated that multiple alcohol concentration tests are provided to the consumer so that testing can occur on more than one occasion to avoid distribution each time the consumer needs the test. Thus, in some embodiments of the present invention, it is desired to have delivery systems comprising multiple alcohol concentration tests that can be accessed on one or more occasions (e.g., over a period of several days during a high risk drunk driving period such as a holiday weekend). In other embodiments, it is desired to have a thin, flat delivery system so that it can be easily distributed to individual consumers through the mail.

Definitions

To facilitate an understanding of the present invention, a number of terms and phrases are defined below:

As used herein, the term "alcohol concentration assay test system" refers to any system capable of determining, either quantitatively or qualitatively, the concentration of alcohol (e.g., ethanol) in a sample. Such assay test systems include both the detection "assay tests" (i.e., alcohol concentration tests) themselves (i.e., devices or combinations of devices that contain sample collection and analyte detection capabilities) and any associated

"delivery systems" (i.e., systems used to store, transport, and maintain assay tests and other items).

As used herein, the term "sample" is used in its broadest sense. In one sense it can refer to a saliva sample. In another sense, it is meant to include a specimen or culture obtained from any source, including biological and environmental samples. Biological samples may be obtained from animals (including humans) and encompass fluids, solids, tissues, and gases. Biological samples include blood products (e.g., plasma and serum), saliva, urine, lachrymal fluid and the like. Environmental samples include environmental material such as surface matter, soil, water, and industrial samples. These examples are not to be construed as limiting the sample types applicable to the present invention.

As used herein, the term "reaction means" refers to compositions that provide for a reaction. For example, reaction means include, but are not limited to: enzymes, cofactors, and buffers for enzymatic reactions; ligands, analytes, or biosensors; and any other composition that facilitates a reaction. In one embodiment of the present invention, the reaction means comprises an alcohol dehydrogenase, NAD(P)H and/or NADH cofactors, a diaphorase, and a chromogen for colorimetrically detecting the presence of ethanol in a sample. In another embodiment, the reaction means comprises an alcohol oxidase. The term "biosensors" refers to any sensor that is partially or entirely composed of biological molecules. In a traditional sense, the term refers to "an analytical tool or system consisting of an immobilized biological material (such as enzyme, antibody, whole cell, organelle, or combination thereof) in intimate contact with a suitable transducer device which will convert the biochemical signal into a quantifiable electrical signal" (Gronow, Trends Biochem. Sci. 9: 336 [1984]). However, as used herein, the term biosensor is not limited to the incorporation or association with transducer devices. The present invention contemplates biosensors with and without transducer devices.

As used herein, the term "immobilization" refers to the attachment or entrapment, either chemically or otherwise, of material to another entity (e.g., a solid support) in a manner that restricts the movement of the material.

As used herein, the term "solid support" refers to any solid substrate that provides a surface for other compositions. For example, solid supports include, but are not limited to, plastic, ceramic, paper, cardboard, or metal supports structures for supporting or enclosing chambers, reactions means, or other compositions. Solid supports can include moveable portions including hinges or sliding portions (e.g., sliding mechanisms), among others.

As used herein, the term "collection site" refers to a portion of a composition capable of collecting a sample. Collection sites include, but are not limited to, wells, chambers, porous membranes, and absorbent materials. The term "absorbent material" includes, but is not limited to, cotton or other thin fiber-based material, paper (e.g., filter paper), cloth, sponge, and other absorbent materials.

As used herein, the term "alcohol metabolizing enzymes" refers to any enzyme capable of reacting with an alcohol substrate. Alcohol metabolizing enzymes include but are not limited to alcohol dehydrogenases and alcohol oxidases. As used herein, the terms "material" and "materials" refer to, in their broadest sense, any composition of matter.

As used herein, the term "enzyme" refers to molecules or molecule aggregates that are responsible for catalyzing chemical and biological reactions. Such molecules are typically proteins but can also be short peptides, RNAs, or other molecules.

As used herein, the term "competitor" refers to an any means capable of reducing the rate of a reaction. In some embodiments, competitors include, but are not limited to competing substrates that compete with another substrate for access to an enzyme active site. The competing substrate may have greater or lessor affinity for the active site than the other substrate. In other embodiments, competitors include, but are not limited to trapping agents that prevent a substrate from reacting with an enzyme or prevent a reaction product from being detected.

As used herein, the term "substantially depleted" refers to a competing substrate that has reacted with an enzyme to such a degree that other substrates are capable of accessing the enzyme at significant levels (e.g., detectable levels).

As used herein, the term "sol-gel" refers to preparations composed of porous metal oxide glass structures. Such structures can have biological (e.g., enzymes) or other material entrapped within the porous structures. The phrase "sol-gel matrices" refers to the structures comprising the porous metal oxide glass with or without entrapped material. The term "sol-gel material" refers to any material prepared by the sol-gel process including the glass material itself and any entrapped material within the porous structure of the glass. As used herein, the term "sol-gel method" refers to any method that results in the production of porous metal oxide glass. In some embodiments, "sol-gel method" refers to such methods conducted under mild temperature conditions. The terms "sol-gel glass" and "metal oxide glass" refer to glass material prepared by the sol-gel method and include inorganic material or mixed organic/inorganic material. The materials used to produce the glass can include, but are not limited to, aluminates, aluminosilicates, titanates, ormosils (organically modified silanes), and other metal oxides.

As used herein, the term "direct colorimetric detection" refers to the detection of color changes without the aid of an intervening processing step (e.g., without conversion of a color change into an electronic signal that is processed by an interpreting device). It is intended that the term encompass visual observing (e.g., observing with the human eye). As used herein, the term "chromophore" refers to molecules or molecular groups ^~ responsible for the color of a compound, material, or sample.

As used herein, the term "aqueous" refers to a liquid mixture containing water, among other components. As used herein, the term "breakable barrier" refers to a barrier between chambers or wells that can be broken, for example, by bending, compressing, heating, snapping, twisting, or other disruptions, such that the contents of the chambers or wells have access to one another.

As used herein, the term "indicator" refers to a detectable signal that indicates the introduction of sufficient sample to a reaction means for a desired (e.g., detectable and reliable) reaction to take place.

As used herein, the term "protective encasement" refers to a thin covering, wrapping or shielding comprising a material that acts to protect a composition such as a reaction means (e.g., to extend the shelf-life of the reaction means).

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides an improved system for measuring if an individual's alcohol concentration is at or above one or more specific levels. The system comprises two parts. The first part is an alcohol concentration assay test. In preferred embodiments, the alcohol concentration test is contained within a single device. In some embodiments, the assay test is also small, fast, accurate, reliable, inexpensive, easy to use, easy to read and decipher, and durable. The second is a delivery system for assay tests that stores one or more assay tests so that assay tests can be accessed on a single occasion or on two or more distinct occasions. The delivery system also, in some embodiments, makes assay tests both durable and easy to access, carry, and distribute, and, in other embodiments, comprises placards that allow instructions, labels, warnings or other text or diagrams to be easily noticed and read. I. Alcohol concentration assay test

A. Description

The alcohol concentration assay test of the present invention finds use in determining alcohol concentrations from samples, including but not limited to saliva, urine, blood, and lachrymal fluid.

The assay test is preferably small in size so that it can be easily carried. For example, in some embodiments, the assay test is rectangular, flat, and thin, such that multiple assay tests can be stored in a delivery system that is convenient to carry. In preferred embodiments, the components of the assay test of the present invention are contained within a single device so that it is easy to use. The assay test comprises two main components: a collection site and a reaction means.

1. Collection Site The assay test comprises a collection site for collecting a sample. In some embodiments of the assay test, the collection site comprises an absorbent material that can absorb a sample (e.g., a fluid such as saliva) from an individual. In some embodiments, the sample flows from the absorbent material to a reaction means (e.g., by diffusion), while in other embodiments the collection site is physically introduced near a reaction means such that the sample is introduced to the reaction means. In yet other embodiment, the reaction means and collection site are in contact with one another or are integrated. Several assay test formats that allow the introduction of the sample from an absorbent material to a reaction means are described below. In other embodiments of the present invention, a sample is directly introduced into a reaction means without an absorbent material (e.g., by introduction of fluid into a collection site comprising a well or chamber).

2. Reaction Means

The assay test further comprises a reaction means for detecting the presence of alcohol in a sample. A wide variety of reaction means are compatible with the present invention. Acceptable reaction means are those that can be incoφorated into the assay tests of the present invention and that can maintain a detectable signal in the presence of alcohol (e.g., ethanol). In some embodiments, the reaction means is selected and tailored to achieve desired reaction speed, accuracy, reliability, cost, and durability. For example, a variety of chemical reactions are known in the art that provide colorimetric detection of ethanol in a sample. Such chemical reactions are described in U.S. Patents 5,032,506, 4,629,697, 4,642,286, 5,290,683, 5,589,349, 5,429,932, 5,429,931, 5,416,004, 4,786,596, 4,810,633, 4,734,360, 5,525,481, 5,141,854, 5,403,749, incoφorated herein by reference in their entireties. A wide variety of biosensors known in the art also find use in the reaction means of the present invention, including, but not limited to the biosensors described in U.S. Patents 5,571,395, 5,792,621, and 5,500,351, incoφorated herein by reference in their entireties. In some embodiments of the present invention, the reaction means provide a colorimetric response that intensifies with increasing concentrations of alcohol (e.g., a gradient reading). In alternate embodiments, the reaction occurs at one particular or multiple threshold levels, as desired (See e.g., U.S. Patent 5,032,506).

In some embodiments that require a series of chemical reactions to take place in sequence, the assay test further comprises multiple chambers for separating, isolating, combining, or storing the reaction components. For example, when a chemical is stored dry, but active only in aqueous solution, separate chambers store the chemical and aqueous solution. D ectly prior to or during use of the assay test, the contents of the chambers are combined (e.g., by breaking a barrier separating the separated components).

In some embodiments of the present invention, the reaction means is immobilized to increase durability, accuracy, and ease of use. For example, in some embodiments the reaction means is immobilized on filter paper, or another material, which allows transfer of the sample to the reaction means and provides a reflective surface for enhanced colorimetric detection. The reaction means may also be immobilized in chambers or in gels. In some embodiments of the present invention, the reaction means is immobilized in a porous metal oxide matrix using the sol-gel method (See generally, Brinker and Scherer, Sol-Gel Science, Academic Press, San Diego [1995]). Sol-gel entrapment provides cost-efficient, stable, accurate, reliable, consistent, and robust materials that can be produced in a variety of shapes and sizes. The unique properties of sol-gel materials such as optical transparency, durability, and tailorable properties (e.g., porosity, surface functionalization, thin films, and bulk materials) provide an ideal material for immobilization of colorimetric materials. The sol-gel process has been used for entrapping organic molecules such as dyes and proteins in silica gels (See e.g., Avnir, Accounts Chem. Res. 28: 328 [1995]; Yamanaka et al., Am. Chem. Soc. 117: 9095 [1995]; Miller et al., Non-Cryst. Solids 202: 279 [1996]; and Dave et al., Anal. Chem. 66: 1120A [1994]). In particularly preferred embodiments, the assay test further comprises an indicator that comprises a second reaction means. The indicator provides a detectable signal indicating the introduction of sufficient sample to the first reaction means for a reaction to take place, ensuring the reliability of the assay test. Several of such preferred embodiments are described in detail below. For example, in one embodiment of the present invention, the indicator is located at the end of a sample path, downstream of the first reaction means. The sample must pass through the first reaction means before reaching the indicator. By providing the indicator with a second reaction means, a positive result with the indicator demonstrates that a sufficient amount of sample has been exposed to the first reaction means.

In other preferred embodiments, the assay test comprises a protective encasement. In some embodiments, the protective encasement comprises a material such as foil and covers the reaction means. In such embodiments, the protective encasement is automatically broken and reveals the reaction means when the user operates the assay test. In still other embodiments, the protective encasement comprises a material such as foil and surrounds the entire assay test. In such embodiments, the user opens the protective encasement to reveal the assay test before operating the assay test.

B. Operation In one preferred embodiment of the present invention, a protective encasement is opened to reveal an assay test. The assay test operates by first saturating an absorbent material on one end of the assay test with a sample. The user then, in one-step, either (1) folds or slides this saturated end into a well on the second region of the assay test, or (2) folds or slides pieces from a second region of the assay test around or onto the saturated end. In preferred embodiments, the folding or sliding motion is designed for quick and easy use. Depending on the reaction means used in the assay test, the user waits for a period of time and inteφrets the detectable signal produced by the reaction means. In embodiments that employ an indicator, to check the reliability of the assay test, the user observes if enough sample was initially put on the absorbent material by viewing a detectable signal from the indicator. The absence of a detectable signal from the indicator demonstrates that not enough sample was initially put on the absorbent material, and that the test may not be reliable. Finally, the user checks their alcohol concentration by viewing a color change or other detectable signal from the reaction means. To make the assay test easy to decipher, the user compares the color changes to pictorial and written instructions printed on the assay test or a delivery system.

II. Delivery System

A. Description

The present invention provides delivery systems for assay tests that stores one or more assay tests so that assay tests can be accessed on a single occasion or on two or more distinct occasions. The delivery system also, in some embodiments, makes assay tests both durable and easy to access, carry, and distribute, and, in other embodiments, comprises placards that allow instructions, labels, warnings or other text or diagrams to be easily noticed and read.

The delivery system of the present invention is preferably small in size so that it can be easily carried. For example, in some embodiments, the delivery system is rectangular, flat, and thin, such that individuals can easily and discreetly carry the delivery systems in their pockets, wallets, or purses for use in situations away from home.

In preferred embodiments, the delivery system stores multiple assay tests so that one or more assay tests can be accessed on a single occasion or on two or more distinct occasions. In some embodiments of the present invention, the delivery system comprises a thin box that includes one or more compartments for multiple assay test storage. In preferred embodiments, the box comprises a material such as hard plastic that protects the assay tests and increases their durability. In particularly preferred embodiments, the delivery system is constructed so that it can be easily opened to access assay tests. In other embodiments, removable protective encasements cover one or more compartments. Storing multiple assay tests so that they can be accessed on a single occasion or two or more distinct occasions has several benefits. Multiple assay tests allow individuals to use more than one assay test on a given occasion, for example, to determine if their alcohol concentration has dropped over time. Additionally, because individuals may use assay tests on separate occasions, the delivery system stores a sufficient quantity of tests to last an individual a period of days, weeks, or months; thereby diminishing the need to continually replenish assay test supply. For example, where the tests are provided to alcohol consumers by a party other than the consumer, the distribution of the system by the secondary party is more efficient (e.g., requires less resources) if multiple tests are distributed at one time rather than providing tests on separate occasions. This is particularly relevant where tests are distributed for use over a period of time comprising a high risk drunk driving period (e.g., holiday weekend). In addition, in some embodiments, it is desirable for the delivery system to be durable so that the assay tests are not damaged during distribution from a secondary party to a consumer (e.g., distribution by mail).

In some embodiments of the present invention, the delivery system is designed to allow easy access to the alcohol concentration tests. For example, tests may be accessed by simply lifting a flap that covers one or more chambers containing the tests. Alternately, the tests may be directly accessed through an opening at one portion of a chamber. In yet other embodiments, the delivery system may comprise a folded structure (e.g., two flaps connected by a hinge) whereby unfolding of the structure reveals one or more of the alcohol concentration tests. In some of these embodiments, exposure of the alcohol concentration tests to the environment is increased in trade for easier access (i.e., the alcohol concentration tests are not completely sealed from exposure to moisture, air, light [e.g., ultra-violet light], heat fluctuations, and the like). In some embodiments, the alcohol concentration tests comprise one or more stabilizers that increase shelf-life in response to environmental exposure.

In some embodiments of the present invention, alcohol concentration tests are contained in a first package. The first package may contain one or more tests. In embodiments where the first package contains more than one test, the test may be contained in one or more compartments in the first package. In some embodiments, the first package is sealed to protect the alcohol concentration tests from the environment. One or more of the first packages are contained in a second package. In preferred embodiments, two or more first packages are contained in a second package which can be independently opened to gain access to the alcohol concentration test. The present invention contemplates delivery systems comprising such first and second packages.

In further embodiments, the delivery system provides placards so that instructions, labels, warnings, or other text or diagrams are easy to notice and read. B. Operation

In one preferred embodiment of the present invention, the delivery system is operated by first easily opening the delivery system. Next, a removable protective encasement that covers a compartment of the delivery system is peeled or folded back or otherwise opened or removed to reveal an assay test. The assay test is then removed for use.

III. Examples

Several examples of the alcohol concentration assay test and delivery systems of the present invention are provided below. These example are provided in order to demonstrate and further illustrate certain preferred embodiments and aspects of the present invention and are not to be construed as limiting the scope thereof.

One embodiment of the alcohol concentration assay test of the present invention is illustrated in Figure 1. The assay test is approximately 1.5 mm in thickness, and has overall dimensions of roughly 5 cm x 1.25 cm, although both larger and smaller dimensions are contemplated and can be designed, as desired.

Figure 2 illustrates the assay test components of the assay test shown in Figure 1. The assay test comprises three main parts, a base 16, a middle 20, and a top 21. The base 16, middle 20, and top 21 are constructed of a strong, durable material such as plastic, although a variety of materials are contemplated by the present invention. In this figure, the attachments to the base 16 include a hinge 15, two filter avenues 18, a well covering 40, an absorbent material 42, and a reaction means impregnated on a thin sheet 14 for detecting the presence of alcohol in a sample. The hinge 15 is constructed in conjunction with the base 16 to form a single molded part. The hinge is made of a thin, flexible material such as plastic, although a variety of materials are contemplated by the present invention. The hinge 15 allows the well covering 40 to easily fold, snap, and lock onto the well 38 on the middle section 20. The hinge 15 also allows the absorbent material 42 to easily fold into the well 38. The filter avenues 18 allow the fluid sample from the absorbent material to travel up both sides of the base 16. A material or body that draws a fluid sample such as filter paper or small capillary tubes is used to construct the filter avenues 18. The well covering 40 is constructed in conjunction with the base 16 to form one molded part. The absorbent material 42 is constructed of a material that absorbs and collects a desired fluid sample (e.g., saliva) such as a synthetic sponge or cotton fibers, although a variety of materials are contemplated by the present invention. The sheet 14 comprises either: (a) a pre-established, fast, inexpensive, and accurate chemical reaction means which produces a controlled color change, (b) a pre-established, fast, inexpensive, and accurate biosensor which produces a controlled color change, or (c) any other accurate, inexpensive, and fast technology that reacts in the presence of alcohol (e.g., ethanol) to produce a controlled detectable signal (e.g., a color change).

The attachments to the middle 20 include a well 38 and a porous membrane 34. The well 38 is constructed in conjunction with the middle 20 to form one molded part. The well 38 is made so that the absorbent material 42 compresses to fit snugly inside. In addition, the well 38 is constructed so that the well covering 40 snaps and locks on top of the well 38. The membrane 34 is located at the bottom of the well 38. It is made of a porous material that allows the fluid sample to pass but does not allow other debris to pass. The attachments to the top 21 include a small window 22, large window 30, and air hole 26. The two windows 22 and 30 are open or transparent spaces that allow the sheet

14 to be viewed through the middle 20. The air hole 26 is a hole in both the top 21 and the middle 20 which allows air to escape from the base 16.

One embodiment of the delivery system of the present invention is illustrated in Figures 3 and 4. The delivery system is rectangular, flat, and thin, similar in size and shape to a credit card, so that it is easy to carry in a wallet, pocket, or purse. The delivery system is approximately 2 mm in thickness, and has overall dimensions of roughly 5.5 cm x 8.25 cm, although smaller or larger delivery systems can be generated as desired. The components of the delivery systems in Figures 3 and 4 are a compartment 44, hinge 45, locking mechanism 48, indentations 56, and three placards 46, 50, and 54. The compartment 44 holds multiple assay tests and can hold fewer or more assay tests than are shown in Figure 3. Assay tests are individually placed in a foil or other protective encasement 72, shown in Figure 12a, so they can be used on separate occasions. In addition, multiple assay tests are individually placed in protective encasements 72 so that the supply of assay tests can last an individual a period of weeks or months. Further, multiple assay tests are contained in the delivery system so that individuals have enough assay tests to determine if their alcohol concentration has dropped over time on one distinct occasion. Alternately, the compartment 44 can be covered with a removable protective encasement, which can be peeled back or otherwise removed to reveal an assay test as shown in Figure 12b.

As shown in Figures 3 and 4, the hinge 45 is constructed in conjunction with the delivery system to form one molded part. The hinge 45 is made of a material such as plastic, although a variety of materials are contemplated by the present invention, that allows the delivery system to be easily opened and closed to access assay tests. The locking mechanism 48 is constructed so that the delivery system closes tightly to protect assay tests. In addition, the delivery system is constructed of a material such as hard plastic, although a variety of materials are contemplated by the present invention, that will protect the assay tests and add to their durability. The indentations 5ό are molded to protrude into the compartment 44 to limit the ability of the assay tests to move and consequently become damaged while inside the delivery system. Finally, three placards 46, 50, and 54 allow instructions, labels, and warnings to be easily noticed and read. Placard 50 refers to the front of the top of the delivery system. Placard 46 refers to the back of the top of the delivery system. Placard 54 refers to the back of the bottom of the delivery system.

Additional embodiments of the assay tests are shown in Figures 8, 9, 10, and 13a-f. There are various possibilities to how the absorbent material 42 is fitted into the well 38 in one easy step. In Figure 8, the hinge 15 allows both the well 38 and well covering 40 to easily fold, snap, and lock around the absorbent material 42. In Figure 9, a sliding mechanism 17 replaces the hinge 15 so that the well 38 and well covering 40 easily slide on top of and tightly lock around the absorbent material 42. There are also various possibilities to the number of parts necessary to build an assay test. In Figure 10, the top 21 is not used. Instead the middle 20 is colored such that the sheet 14 cannot be viewed except through the windows 30 and 22. In addition, there are various possibilities for the location of the reaction means. In figures 13a-f, the reaction means is located on a sheet 14 and/or in one or more chambers 31. In figures 13a-f, when an individual folds or slides the assay test to operate it, a protrusion 33 breaks open a chamber 31 and introduces the chamber's contents to the sheet 14, thereby releasing or mixing the components of the reaction means. An additional embodiment of the delivery system is shown in Figure 11. There are various possibilities to constructing a rectangular, flat, and thin delivery system that provides multiple placards and stores tests while making them easy to carry, easy to access on one or more occasions, and durable. In Figure 11, there are five hinges 45. Each hinge 45 breaks off to reveal separate compartments containing assay tests.

From the description above, a number of advantages of the alcohol concentration assay test systems of the present invention become evident. Because the assay test is contained within a single device, it is easy to use. For example, in some embodiments, the hinge on the assay test allows the test to be easily used in one step. In other embodiments, the assay test comprises a reaction means which relies on a chemical (e.g., enzymatic), biosensor, or other technology that provides the assay test with fast and accurate detection capabilities, lowers costs, and produces a controlled color or other detectable change. In some embodiments, the assay test has an indicator that ensures reliability by allowing the user to check if enough sample was put on the absorbent material. Also, in other embodiments, the large, easy to see window allows results to be easily read, and the pictorial and written instructions that appear on the assay test and/or delivery system allow results to be easily deciphered and inteφreted.

Because the assay test and the delivery system are small and have relatively few parts, in some embodiments, the assay test and delivery system are inexpensive to manufacture. Because the delivery system comprises a rectangular, flat, and thin design, similar in size and shape to a credit card, in some embodiments, it is easy to carry in a wallet, pocket, or purse. Because the delivery system stores multiple assay tests that are protected by their own protective encasements, assay tests are easy to access individually on one or multiple occasions. In some embodiments, the hard material of which the delivery system is constructed protects the assay tests and adds to their durability. In yet other embodiments, the delivery system provides large placards that allow instructions, labels, and warnings to be easily noticed and read.

In some embodiments of the present invention, the delivery system operates by first unlocking the locking mechanism 48. Next, a user folds open the delivery system and removes one assay test enclosed in a protective encasement 72. The encasement 72 is then easily ripped open and an assay test is removed. As shown in Figure 5, a user then saturates an absorbent material 42 on one end of the assay test with a saliva sample. Next, as shown in Figure 6, the user, in one step, folds this saturated end into a well 38 on the opposite part of the test. The folding motion is quick and easy. Depending on the technology impregnated on the sheet 14, the user waits a short period of time. To check if enough saliva was initially put on the absorbent material 42, at the end of the waiting period, the user observes a color change or other detectable signal in the small circular window 22. The absence of a change in the window 22 indicates that enough saliva may not have been initially put on the absorbent material 42, and the assay test should not be used. Finally, the user checks if their saliva alcohol concentration level is at or above a specific level by viewing a color change or other detectable signal in the large, easy to read, octagon shaped window 30. To make the assay test easy to decipher, the user compares the color changes or other detectable signals in the windows 22 and 30 to pictorial and written instructions printed on the test 58, 62, 66, and 68, and on the delivery system placards 46, 50, and 54.

In another embodiment of the present invention the delivery system comprises first and second packages. As shown in Figure 14, a first package 102 contains an alcohol concentration test 105. In some embodiments, the first package comprises multiple compartments, each of which contain one or more alcohol concentration tests. The first package 102 comprises a first wall 103 and a second wall 104. The walls may be a single material or may comprises layers of different materials. In some embodiments, the walls comprise a heat sealed plastic inner layer, a foil intermediate layer, and a paper outer layer. In some embodiments, the first package is sealed, preventing exposure of the alcohol concentration test to the environment. A second package 99 comprises a first wall 100 and a second wall 101. The first and second walls are sealed along three sides. The open end provides an opening for the insertion or removal of one or more of the first packages 102 between the first wall 100 and second wall 101. In preferred embodiments, the second package is the approximate size and shape of a standard credit card. In some preferred embodiments, the first or second wall of the second package further comprises a thumb notch at the unsealed side to facilitate entry or removal of the first packages.

In another embodiment shown in Figure 15, a first package 205 (as described above for first package 102) is enclosed in a second package 200. The second package 200 comprises a first wall 201 with an inner surface 203 and a second wall 202 with an inner surface 204. The first wall 201 and second wall 202 are connected along one edge by a hinge 206. The first package 205 is attached to the inner surface 204 of the second wall 202. When the hinge 206 is in the closed position, the first package 205 is enclosed within the second package 200. When the hinge 206 is in an open position, the first package 205 is accessible.

In another embodiment shown in Figure 16 the delivery system 300 comprises a solid support 301 and an alcohol concentration test 305 enclosed within a package 302. In some embodiments, the package 302 comprises multiple compartments, each of which contain one or more alcohol concentration tests. The package comprises a first wall 303 and a second wall 304. The walls may be a single material or may comprises layers of different materials. In some embodiments, the walls comprise a heat sealed plastic inner layer, a foil intermediate layer, and a paper outer layer. In some embodiments, the first package is sealed, preventing exposure of the alcohol concentration test 305 to the environment. The second wall 304 of the package 302 is attached (e.g., glued) to the solid support 301. In preferred embodiments, the delivery system 300 is approximately the size and shape of a standard credit card.

Accordingly, it is clear that the alcohol concentration assay test system of the present invention comprises assay tests and delivery systems that have many significant advantages. In some embodiments, the assay test is contained within a single device so that it is easy to use. In some embodiments, the assay test is also small, fast, accurate, reliable, inexpensive, and durable. In addition, in some embodiments, assay test results are easy to read and easy to decipher using either the delivery system or the assay test itself. The assay test relies on either a chemical, biosensor, or other detection technology as a reaction means. The delivery system stores multiple assay tests so that the assay tests can be easily accessed on one or more occasions. In some embodiments, the delivery system makes assay tests both easy to carry and durable. In other embodiments, the delivery system provides placards for instructions, warnings, and labels. All publications and patents mentioned in the above specification are herein incoφorated by reference. Various modifications and variations of the described method and system of the invention will be apparent to those skilled in the art without departing from the scope and spirit of the invention. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention which are obvious to those skilled in the relevant fields are intended to be within the scope of the following claims.

Claims

CLAIMSWe claim:

1. A system comprising a diagnostic device for analyzing saliva for the presence of ethanol, said diagnostic device comprising: a) a solid support; b) a collection site attached to a first portion of said solid support, wherein said collection site is capable of collecting a saliva sample; c) a reaction means attached to a second portion of said solid support, wherein said reaction means produces a detectable signal in the presence of ethanol only above a threshold concentration of alcohol; wherein said solid support, collection site, and reaction means are contained within a single device.

2. The system of Claim 1, wherein said diagnostic device comprises a thickness, a width, and a length, wherein said thickness is 1.5 millimeters or less, said length is 5 centimeters or less, and said width is 1.25 centimeters or less.

3. The system of Claim 1, wherein said solid support comprises plastic.

4. The system of Claim 1, wherein said collection site comprises an absorbent material.

5. The system of Claim 1, wherein said reaction means comprises one or more alcohol metabolizing enzymes.

6. The system of Claim 1, wherein said reaction means compπses one or more biosensors.

7. The system of Claim 5, wherein said reaction means further comprises one or more competitors.

8. The system of Claim 1, wherein said threshold concentration of alcohol corresponds to a blood alcohol concentration of 0.04%.

9. The system of Claim 1, further comprising a delivery system, said delivery system comprising one or more compartments capable of storing one or more of said diagnostic devices.

10. The system of Claim 9, wherein said delivery system further comprises one or more protective encasements capable of enclosing said diagnostic devices in said one or more compartments.

11. The system of Claim 9, wherein said delivery system further comprising one or more placards.

12. An alcohol concentration assay test delivery system comprising two or more compartments each capable of containing at least one alcohol concentration assay tests.

13. The alcohol concentration assay test delivery system of Claim 12 wherein said delivery system further comprises one or more protective encasements capable of enclosing said alcohol assay tests in said one or more compartments.

14. The alcohol concentration assay test delivery system of Claim 13, wherein said protective encasement comprises at least one opening.

15. The alcohol concentration assay test delivery system of Claim 12, wherein said deliver}' system comprises a thickness, a width, and a length, wherein said thickness is 2 millimeters or less, said length is 8.5 centimeters or less, and said width is 5.5 centimeters or less.

16. The alcohol concentration assay test delivery system of Claim 12, further comprising one or more placards.

17. The alcohol concentration assay test delivery system of Claim 12, wherein said delivery system comprises plastic.

18. The alcohol concentration assay test delivery system of Claim 12 further comprising one or more alcohol concentration assay tests wherein said one or more alcohol assay tests are contained within said two or more compartments.

19. An alcohol concentration assay test delivery system comprising: a) one or more alcohol concentration assay tests; b) two or more first packages comprising one or more compartments, wherein said one or more alcohol concentration assay tests are contained in said first packages; and c) a second package, wherein said two or more first packages are contained in said second package.

20. An alcohol concentration assay test delivery system comprising: a) one or more alcohol concentration assay tests; b) two or more first packages comprising one or more compartments, wherein said one or more alcohol concentration assay tests are contained in said first packages; and c) a second package, wherein said two or more first packages are attached to said second package.