|Publication number||US20050119589 A1|
|Application number||US 10/990,295|
|Publication date||Jun 2, 2005|
|Filing date||Nov 15, 2004|
|Priority date||Nov 14, 2003|
|Also published as||CA2545056A1, CA2545056C, CA2545125A1, CA2545215A1, CN1882835A, CN1882835B, CN1882836A, CN1954203A, CN100538326C, CN100594381C, CN101832885A, CN101876657A, CN101876657B, DE212004000059U1, DE212004000060U1, DE212004000061U1, DE602004031253D1, EP1687608A2, EP1687608A4, EP1687628A2, EP1687628A4, EP1687628B1, EP1692501A2, EP1692501A4, US7544324, US7837939, US20050180882, US20050202568, US20090117665, WO2005050165A2, WO2005050165A3, WO2005050166A2, WO2005050166A3, WO2005050167A2, WO2005050167A3|
|Publication number||10990295, 990295, US 2005/0119589 A1, US 2005/119589 A1, US 20050119589 A1, US 20050119589A1, US 2005119589 A1, US 2005119589A1, US-A1-20050119589, US-A1-2005119589, US2005/0119589A1, US2005/119589A1, US20050119589 A1, US20050119589A1, US2005119589 A1, US2005119589A1|
|Inventors||Hsiaoho Tung, Yuzhang Wu, Jielin Dai, Ying Yang|
|Original Assignee||Tung Hsiaoho E., Yuzhang Wu, Jielin Dai, Ying Yang|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (74), Referenced by (9), Classifications (28), Legal Events (3)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application claims priority to U.S. provisional patent application Ser. No. 60/520,437, filed Nov. 14, 2003, which is incorporated by reference herein, including all Tables, Figures and claims.
The present invention is directed to devices for the rapid analysis of fluids for analytes of interest and the storage of those fluids.
The following Background of the Invention is intended to aid the reader in understanding the invention and is not admitted to be prior art.
Illicit drug use is an established and growing problem in our society. In 2003, the US Department of Health and Human Services found that an estimated 19.5 million Americans or 8.2 percent of the population aged 12 or older, were current illicit drug users. Current illicit drug use means use of an illicit drug during the month prior to the US Department of Health and Human Services survey interview. Marijuana was found to be the most commonly used illicit drug, with a rate of 6.2 percent (14.6 million). An estimated 2.3 million persons (1.0 percent) were current cocaine users, 604,000 of whom used crack. Hallucinogens were used by 1.0 million persons, and there were an estimated 119,000 current heroin users.
To combat and monitor this problem, drug testing has become standard procedure in a variety of settings, such as employment, school, sports, law enforcement, and the like. To facilitate this effort, a drug-testing industry has emerged. This industry provides a variety of drug testing products. A typical product is a urine collection cup incorporating analysis tests. These devices can be complicated and difficult or messy to use, or they may pose special problems of sample adulteration by the subject trying to hide their recent drug abuse.
There is therefore a need for better methods and apparatuses for performing sample collection and testing.
The present invention is directed to devices for detecting an analyte suspected of being present in a fluid sample. In one embodiment the devices are for detecting analytes of interest in body fluids, such as saliva or oral fluid. The devices have a casing which contains a port for positioning of a sample collection well. The sample collection well has a chamber for collection and storage of a confirmation sample, and contains a plunger which has a raised and a lower position. In some embodiments the sample collection well has an upper and a lower chamber, and the lower chamber is present when the plunger is in the lower position, and also collects fluid sample to be analyzed. The device also has a sample outlet sealed by a frangible material which provides liquid communication between the sample collection well and the test compartment when the sample outlet is open. The device also has an expression plate, which allows the user to express sample into the device from a sample applicator that has an absorbent member for collecting the fluid sample. In some embodiments the lance is attached to the bottom end of the plunger. The sample outlet is opened by moving the plunger to the lower position, which causes the lance to break the frangible material and open the sample outlet, thereby providing liquid communication between the sample collection well and the test compartment. In embodiments where a screw cap is used, the plunger is lowered by screwing on the cap, the bottom of which interacts with the plunger or a piece connected thereto, and forces the plunger into the lower position. Kits containing the devices, and methods of using the devices are also provided.
In a first aspect, the present invention provides a test device for detecting an analyte suspected of being present in a fluid sample. The device has a casing, having a port for a sample collection well. The device further contains a test compartment containing at least one test element. The sample collection well is situated in the port, and has an expression plate, and a plunger having a raised position and a lower position. The device also has a chamber for storage of a confirmation sample. A lance is also contained within the device, and in one embodiment is carried by the plunger. The device also has a sample outlet sealed by a frangible material that provides liquid communication between the sample collection well and the test compartment when the sample outlet is open. The device also has a cap for the sample collection well, where a portion of the cap interacts with the plunger to move the plunger from the raised position to the lower position when the cap is applied to the sample collection well.
The term “plunger” refers to a part of the device that moves through a portion of the device to bring two parts into contact and perform a function in the operation of the device. In one embodiment the plunger moves within a circular or cylindrical part of the device. In some embodiments the plunger carries a lance and serves to deliver the lance to a frangible material that is pierced by the lance. A “lance” is an object that pierces a frangible seal. The lance will typically be sharp or otherwise have the capability to pierce the frangible seal. The “port” is a portion of the device where the casing interfaces with the sample collection well. The port can be an opening into which the sample collection well fits reversibly, or the sample collection well and casing can be produced as a single unit. The port also provides access between the sample collection well and the test compartment.
An “expression plate” refers to a surface where a sample applicator filled with fluid sample can be squeezed or crushed against to express sample from the applicator. The expression plate can have openings or holes to allow the passage of fluid sample from the applicator to the sample collection well. The expression plate can be located within the sample collection well, but can also be placed in another location where expressed sample will flow to the collection well. In one embodiment the expression plate is located in the sample collection well and divides the upper and lower chambers, and has one or more holes or openings through which fluid sample can flow from the upper chamber to the lower chamber. When the sample collector is pressed against the expression plate, sample flows through the opening in the expression plate, into the lower chamber.
The “test element” can be any element that performs a test. In one embodiment, the test element is a test strip. The test strip may contain a member of a specific binding pair on the test strip for conducting an immunoassay. The test strip may be a chemical test strip that provides a detectable color change or other detectable signal when the assay is complete. A variety of samples can be used with the present invention including, but not limited to, a bodily fluid or a sample derived from a biological tissue or a bodily fluid. For example, the sample may be saliva, blood, serum, plasma, urine, feces, spinal fluid, vaginal swabs, mucus, and tissue. In one embodiment, the expression plate divides the upper chamber from the lower chamber, and has an aperture for flow of liquid sample from the upper chamber to the lower chamber.
The “sample outlet” provides liquid communication from the sample collection well to the test compartment. The sample outlet in the device is sealed by a frangible material, and liquid communication does not occur between the sample collection well and test compartment until the frangible seal is pierced or broken by the lance, which is lowered into the frangible material by the plunger to begin the assay.
In one embodiment the sample collection well also has a lower chamber present when the plunger is in the raised position, and an upper chamber where the confirmation sample is stored. In one embodiment the sample collection well contains the plunger, upper and lower chambers, the expression plate, and the sample outlet, however, in other embodiments these components can be located outside the sample collection well. In one embodiment, expression plate divides the upper chamber from the lower chamber, and has an aperture for flow of liquid sample from the upper chamber to the lower chamber. The lance can be carried on the plunger (e.g., on the bottom surface of the plunger), and can be downwardly-projecting and perpendicularly aligned with the sample outlet for breaking the frangible material. The sample collection well and cap can have complementary engaging screw threads. In one embodiment the cap carries a downward projection that interacts with the plunger when the cap is applied to the sample collection well. The expression plate can have an opening through which the projection passes to interact with (and push) the plunger. By “complementary engaging screw threads” is meant that the cap and sample collection well each have screw threads which are complementary and the cap can be screwed onto the sample collection well to obtain a fit by rotation of the cap on the sample collection well and engagement of the screw threads, and where liquid sample does not leak from around the cap.
In certain embodiments of the present invention, the lower chamber is absent when the plunger is in the lower position. This can be due to the lower chamber existing under the plunger, and disappearing when the plunger is lowered and the lance pierces the frangible material. The frangible material can be any material that is pierceable by a lance. Examples of frangible materials include (but are not limited to) paper, wax-coated paper, plastic-coated paper, plastic film, a thin plastic sheet, adhesive tape, foil, waxed foil and plastic-coated foil.
In some embodiments, the test element is a test strip. The test strip may have specific binding molecules immobilized on the test strip, but can also have a chemical test. The fluid sample can be any fluid such as (for example) oral fluid, saliva, blood, serum, plasma, urine, feces, spinal fluid, vaginal swabs, mucus, and tissue. “Saliva” refers to the excretions of the salivary glands. “Oral fluid” is any fluid present in the buccal cavity and saliva is a major component of oral fluid. Any analyte can be detected using the present invention for which a test element exists. For example, the analyte can be a drug (such as a drug of abuse), a hormone, a protein, a peptide, a nucleic acid molecule, an etiological agent and a specific binding pair member. In a further embodiment, the upper and lower chambers are present in the sample collection well when the plunger is in the raised position, and the lower chamber is not present when the plunger is in the lower position. In another embodiment the sample collection well is sealed when the lance punctures the frangible material. The sample collection well can be sealed by seals present on the lower portion of the plunger and/or seals located at or around the reservoir. Thus, when the plunger is lowered the sealing bodies provide a seal to the sample collection well.
In another aspect, the present invention provides a kit having a device described herein, and a sample applicator. In one embodiment of the present invention, the sample applicator has an absorbent member and a handle. The absorbent member may be a sponge, a foam, or any material that absorbs liquid. The absorbent member can be soaked in or pre-treated with a solution that stimulates salivation in a test subject. The kit can also contain instructions for use of the device. In one embodiment the instructions are for use of the device for the detection of an analyte in a fluid sample.
In another aspect the present invention provides methods of detecting the presence of an analyte in a fluid sample. The methods involve applying the fluid sample to a device as described herein, applying the cap to the sample collection well, engaging the plunger and lowering the plunger so that the lance punctures the frangible material and releases the fluid sample into the test compartment, and determining the presence of the analyte in the fluid sample. In certain embodiments, applying the sample includes contacting a sample applicator with the fluid sample, inserting the sample applicator into the sample well, and pressing the sample applicator against the expression plate to express the fluid sample into the sample collection well. The expressed fluid sample flows into the lower chamber of the sample collection well and a portion of the fluid flows from the upper chamber around at least one edge of the plunger and into the lower chamber.
In another embodiment of the present method, after fluid sample is applied to the sample collection well, the cap is applied to the sample collection well and the plunger is lowered to puncture the frangible material as the cap is applied, thereby providing fluid communication between the sample collection well and the test compartment. In certain embodiments, the fluid sample flows from the lower chamber to the test compartment when the plunger punctures the frangible material. The sample collection well and cap can further comprise complementary engaging screw threads. When the cap is screwed onto the sample collection well, a portion of the cap interacts to provide a force onto the plunger and thereby lower the plunger and puncture the frangible material. In one embodiment, the lower chamber is not present when the plunger is in the lower position. The force applied to the plunger may be a direct force from the bottom of the cap to the back of the plunger.
The summary of the invention described above is not limiting and other features and advantages of the invention will be apparent from the following detailed description, as well as from the claims.
In the following detailed description, reference is made to the accompanying drawings that form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. It is understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the present invention.
The devices and methods of the present invention enable the easy detection of analytes in fluid samples. The devices also allow a quantity of sample to be easily stored for confirmatory testing later in a reservoir within the device, using a different principle of testing if desired. The confirmation sample is therefore safely stored from contamination. The device also allows the user to control the time of beginning the assay, because the user can apply sample to the sample collection well and fill the sample collection well, but the assay will not begin until the user applies the cap to the sample collection well and lowers the plunger, thereby puncturing the frangible material and releasing the fluid sample into the test compartment.
Sample Analysis and Storage Device
The present invention provides a test device for detecting an analyte in a fluid sample, and for storing an aliquot of the sample for confirmation testing.
Embodiments of the device are possible where no upper and lower chambers are present, but a single chamber performs the functions. The expression plate can also be located at a point removed from the sample collection well, and the fluid sample transferred to the test compartment. Also, the lance can be carried on the plunger, which can be present in the sample collection well (as shown in the Figures), but the lance can also be present as a separate component, either within or outside of the sample collection well.
The plunger may be made of a variety of materials, such as injection-molded or press-molded plastic. The plunger has a face, which is the portion opposite the cap and closest to the sample outlet, and a back which is the portion of the plunger body closest to the cap. The plunger can carry the lance on its face side. The plunger can also have arms which extend towards the cap, so that the bottom of the cap interfaces with the plunger arms to apply force on the plunger and drive it and the lance into the frangible material. The lance is sufficiently sharp and hard to break the fungible material that has been chosen to cover the sample outlet. The lance can be manufactured as an integral part of the injection-molded plastic plunger, or incorporated into the plastic plunger.
In one embodiment, the device has a cap 220 for the sample collection well (see
In certain embodiments, the plunger carries a lance 340 on its bottom surface. The lance on the bottom of the plunger can be downwardly-projecting towards the sample outlet, and is aligned with the outlet for breaking the frangible material. In one embodiment the plunger is perpendicularly aligned with the plane of the outlet. As the plunger is moved to its lower position, the lance moves into and punctures the frangible material, and sample in the sample collection well (e.g., from the lower chamber) flows into the test compartment. The frangible material may be made of any convenient material, such as paper, wax-coated paper, plastic-coated paper, plastic film, a thin plastic sheet, adhesive tape, foil, waxed foil and plastic-coated foil. The frangible material may be attached with adhesive.
In one embodiment the lance can also have affixed to its lower edge a seal, so that when the plunger is in the lower position a seal is effected between the sample collection well and the test compartment. The seal can be made of rubber, plastic, or any material that can form a seal over the outlet when the plunger is in the lower position.
As shown in
In another embodiment of the present device, the test compartment contains at least one test element 280, for example, a test strip. A variety of analyte test strips can be incorporated into the present invention which is discussed in greater detail below. Sample comes into contact with the test strips when the plunger has been pushed into the lowered position and the frangible seal is broken. When the frangible seal breaks, sample that is present in the lower chamber flows through the sample outlet and contacts the wicking paper 260. The wicking paper moves the sample by capillary action to the sample loading end of the test strips (see below) and the tests are initiated. While the illustrated embodiments use wicking paper, it is also possible to not use wicking paper and allow the sample to flow directly to the test element. The test results can be read through a window 370 provided in the top of the casing. Indicia may be provided next to the window, to indicate to the user where to expect test result lines and control lines.
A sample applicator may be supplied with the device of the present invention. In one embodiment the sample applicator has an absorbent member 140 and a handle 144. The absorbent member can be made of medical grade sponge or foam material commonly used in the art. But many other materials are available for use as an absorbent member, such as cotton or paper, or any material having suitable absorbent capacity. The handle is generally rigid, to facilitate manipulation of the absorbent member. The handle may be made of any material commonly employed in the art, such as plastic, wood, metal or cardboard. In one embodiment the handle has a rim 142 (
In some embodiments of the present invention, the upper chamber of the sample application well may have ribs. The sample applicator can be adapted so that its rim locks under the ribs when the applicator has been sufficiently pressed against the expression plate and then twisted to fit under the ribs. This may ensure that the absorbent member of the applicator has been sufficiently squeezed for a sufficient amount of time to express as much sample contained therein as possible.
A variety of test elements can be incorporated into the present invention. One type of test element is a test strip. Analyte test strips are test elements provided in a variety of formats, such as immunoassay or chemical test format, for detecting analytes of interest in a sample, such as a drug of abuse or a metabolite suggestive of health status. Test strips can also be provided in either noncompetitive or competitive assay formats. In some formats, the test strips have a bibulous material having a sample application zone, a reagent zone and a test result zone. The sample is applied to the sample application zone and flows into the reagent zone by capillary action. In the reagent zone, the sample dissolves and mixes with reagents necessary for detection of the analyte (if it is present in the sample). The sample, now carrying the reagents, continues to flow to the test results zone. Additional reagents are immobilized in the test results zone, such as a specific binding molecule for the analyte. These reagents react with and bind the analyte (if present) or one of the first reagents from the reagent zone. Labels for forming the detectable signal can be present in the reagent zone, or a separate label zone.
In noncompetitive formats, a signal is produced if the sample contains the analyte, and no signal is produced if the analyte is not present. In competitive formats, a signal can be produced if no analyte is present, and no signal if analyte is present.
When the test element is a test strip, it may be made of bibulous or non-bibulous material. A test strip can include more than one material, which are then in fluid communication. One material of a test strip may be overlaid on another material of the test strip, such as for example, filter paper overlaid on nitrocellulose. Alternatively or in addition, a test strip may include a region comprising one or more materials followed by a region comprising one or more different materials. In this case, the regions are in fluid communication and may or may not partially overlap one another. The material or materials of the test strip can be bound to a support or solid surface such as a supporting sheet of plastic, to increase its handling strength.
In embodiments where the analyte is detected by a signal producing system, such as by one or more enzymes that specifically react with the analyte, one or more components of the signal producing system can be bound to the analyte detection zone of the test strip material in the same manner as specific binding members are bound to the test strip material, as described above. Alternatively or in addition, components of the signal producing system that are included in the sample application zone, the reagent zone, or the analyte detection zone of the test strip, or that are included throughout the test strip, may be impregnated into one or more materials of the test strip. This can be achieved either by surface application of solutions of such components or by immersion of the one or more test strip materials into solutions of such components. Following one or more applications or one or more immersions, the test strip material is dried. Alternatively or in addition, components of the signal producing system that are included in the sample application zone, the reagent zone, or the analyte detection zone of the test strip, or that are included throughout the test strip, may be applied to the surface of one or more test strip materials of the test strip as was described for labeled reagents.
The zones can be arranged as follows: sample application zone, one or more reagent zones, one or more test results determination zones, one or more control zones, one or more adulteration zones, and fluid absorbing zone. If the test results determination zone includes a control zone, preferably it follows the analyte detection zone of the test result determination zone. All of these zones, or combinations thereof, can be provided in a single strip of a single material. Alternatively, the zones are made of different materials and are linked together in fluid communication. For example, the different zones can be in direct or indirect fluid communication. In this instance, the different zones can be jointed end-to-end to be in fluid communication, overlapped to be in fluid communication, or be communicated by another member, such a joining material, which is preferably bibulous such as filter paper, fiberglass or nitrocellulose. In using a joining material, a joining material may communicate fluid from end-to-end joined zones or materials including such zones, end-to-end joined zones or materials including such zones that are not in fluid communication, or join zones or materials that include such zones that are overlapped (such as but not limited to from top to bottom) but not in fluid communication.
When and if a test strip includes an adulteration control zone, the adulteration control zone can be placed before or after the results determination zone. When a control zone is present in the results determination zone on such a test strip, then the adulteration control zone is preferably before the control zone, but that need not be the case. In the embodiment of the present invention where a test strip is a control test strip for the determination of an adulteration analyte and/or a control, then the adulteration control zone can be placed before or after the control zone, but is preferably before the control zone. The reagents used in the adulteration assay determine whether there has been an attempt to defeat the purpose of the assay by the test subject, such as by adding material to the sample to change the results of the assay.
Samples that can be tested with the device of the present invention include liquids of biological origin (e.g., casing fluids and clinical samples). Liquid samples may be derived from solid or semi-solid samples, including feces, biological tissue, and food samples. Such solid or semi-solid samples can be converted into a liquid sample by any suitable method, for example by mixing, chopping, macerating, incubating, dissolving or enzymatically digesting solid samples in a suitable liquid (e.g., water, phosphate-buffered saline, or other buffers). “Biological samples” include samples derived from living animals, plants, and food, including for example urine, saliva, blood and blood components, cerebrospinal fluid, vaginal swabs, semen, feces, sweat, exudates, tissue, organs, tumors, tissue and organ culture, cell cultures and conditioned media therefrom, whether from humans or animals. A preferred biological sample is urine. Food samples include samples from processed food components or final products, meat, cheese, wine, milk and drinking water. Plant samples include those derived from any plant, plant tissue, plant cell cultures and conditioned media therefrom. “Environmental samples” are those derived from the environment (e.g., a water sample from a lake or other casing of water, effluent samples, soil samples, ground water, ocean water, and runoff water. Sewage and related wastes can also be included as environmental samples.
Any analyte can be tested for utilizing the present invention and a suitable test element. In particular, the present invention can be utilized for the detection of a drug of abuse in oral fluid. A “drug of abuse” (DOA) is a drug that is taken for non-medicinal reasons (usually for mind-altering effects). The abuse of such drugs can lead to physical and mental damage and (with some substances) dependence, addiction and/or death. Examples of DOAs include cocaine; amphetamines (e.g., black beauties, white bennies, dextroamphetamines, dexies, beans); methamphetamines (crank, meth, crystal, speed); barbiturates (ValiumŪ, Roche Pharmaceuticals, Nutley, N.J.); sedatives (i.e. sleep-aids); lysergic acid diethylamide (LSD); depressants (downers, goofballs, barbs, blue devils, yellow jackets, ludes); tricyclic antidepressants (TCA, e.g., imipramine, amitriptyline and doxepin); phencyclidine (PCP); tetrahydrocannabinol (THC, pot, dope, hash, weed, etc.); and opiates (e.g., morphine, opium, codeine, heroin, oxycodone).
Additional analytes that can be tested using the present invention include but are not limited to creatinine, bilirubin, nitrite, protein (nonspecific), hormones (e.g. human chorionic gonadotropin, luteinizing hormone, follicle stimulating hormone, etc.), blood, leukocytes, sugar, heavy metals or toxins, bacterial components (e.g. proteins or sugars specific to a particular type of bacteria, such as E. coli0157:H7, S. aureus, Salmonella, C. perfringens, Campylobacter, L. monocytogenes, V. parahaemolyticus, or B. cereus) and physical characteristics of the urine sample, such as pH and specific gravity. Any other clinical urine chemistry analyte that can be adapted to a lateral flow test format may also be incorporated into the present device.
Methods of Use
The following discussion relates to those embodiments illustrated in the examples. Of course other embodiments are possible without departing from the scope of this invention. In the methods of the invention, the step of applying the sample to the device can include contacting a sample applicator with the fluid sample, for example, by inserting it into the mouth of a test subject or by immersing it in a container of fluid sample. The filled or soaked applicator 144 can be inserted into the sample collection well 130, and the applicator pressed or squeezed against the expression plate 230 to express the fluid sample into the sample collection well (see
After sample is completely expressed, the cap 220 can be applied to the sample collection well (see
Test kits of the invention can be packaged in a variety of formats, depending upon the customer's needs. For example, a facility that conducts large numbers of pre-employment drug screenings may prefer boxes of 1 set of instructions plus 20 vacuum packed set of devices and applicators. On the other hand, other users may prefer boxed kits that contain only one device, one sample collector, and one set of instructions. Any suitable packaging materials can be used. Test kits may be packaged in a box, or may be wrapped in protective material such as cellophane. Test kits may also be provided with a test device (and applicator) provided in the same or separate sealed pouches, which may or may not then be provided in a box or other packaging.
The devices of the invention can be utilized in a variety of contexts. This example illustrates a use of the device for pre-employment drug screening. The person to be tested provides a sample of saliva by placing the sample applicator into his or her mouth, and allowing it to remain in the mouth for about 5 minutes. In embodiments for pre-employment drug screening the device contains test strips for several common drugs of abuse, in this embodiment cocaine, methamphetamine, phencyclidine, THC, morphine, and amphetamines. The device utilizes test strips in a competitive immunoassay format where labeled specific binding molecules (antibodies labeled with gold sol in this embodiment) for each drug being tested are present on the label zone of the test strip. The test lines contain the antigen being tested for. If analyte is present in the sample it is bound by labeled specific binding molecules in the label zone, thereby preventing the labeled antibody from binding to the test line. Thus, no signal occurs on the test line when analyte is present. Conversely, when no antigen is present in the sample, the labeled antibodies bind to the test line providing the signal on the test line.
After receiving the filled or soaked sample applicator, the testing technician inserts it into the sample collection well of the device. The technician presses the applicator down into the well and then twists it, to lock the rim of the applicator under a pair a flanges 410 (provided in this embodiment). Saliva is thereby expressed from the absorbent foam of the sample applicator and flows through the orifice in the expression plate and into the chamber below the expression plate. Since the plunger is in the first position, some of the sample flows around the edges of the plunger into the lower chamber of the sample collection well. When all sample is expressed from the foam, the applicator is removed and the cap is screwed onto the sample collection well. As the cap is screwed onto the sample collection well, the downward projection of the cap pushes the plunger from the raised position to the lowered position, thereby driving the lance into the frangible seal, breaking the seal, and opening the sample outlet. Sample then flows into the test compartment, where it comes into contact with the test strips. At the same time, the portion of the sample remaining in the upper chamber, above the plunger is isolated from the rest of the apparatus, because the plunger becomes a seal between the upper chamber and the test compartment and thereby creating a reservoir to hold the remaining sample. After a few minutes, the control indicia are provided on the test elements, indicating that the assay is complete. A signal is provided at each of the test lines, indicating that no drugs of abuse are present in the saliva sample (competitive assay format). If a positive result is determined, the device may be sent to a confirmatory laboratory so that the sample contained in the reservoir can be tested to confirm the result.
With reference to the present disclosure the person of ordinary skill in the art will realize that any analyte for which a test element is available or later developed can be used in the present invention. Thus, any other drugs of abuse of interest can be tested for, and several example are listed herein. Similarly, any analyte from any sample type can be tested for.
The invention illustratively described herein may be practiced in the absence of any element or elements, limitation or limitations that are not specifically disclosed herein. The terms and expressions which have been employed are used as terms of description and not of limitation, and there is no intention that in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the invention claimed. Thus, it should be understood that although the present invention has been specifically disclosed by various embodiments and optional features, modification and variation of the concepts herein disclosed may be resorted to by those skilled in the art, and that such modifications and variations are considered to be within the scope of this invention as defined by the appended claims.
The contents of the articles, patents, and patent applications, and all other documents and electronically available information mentioned or cited herein, are hereby incorporated by reference in their entirety to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference. Applicants reserve the right to physically incorporate into this application any and all materials and information from any such articles, patents, patent applications, or other documents.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US3896974 *||Jun 7, 1974||Jul 29, 1975||Mack Wayne Plastics Co||Container and closure therefor|
|US4114605 *||Nov 2, 1976||Sep 19, 1978||University Of Alabama In Birmingham||Intraoral cup for collecting saliva and method of using the same|
|US4635488 *||Dec 3, 1984||Jan 13, 1987||Schleicher & Schuell, Inc.||Nonintrusive body fluid samplers and methods of using same|
|US4768238 *||May 4, 1987||Sep 6, 1988||Interstate Drug Exchange||Bifurcated saliva collector|
|US4771486 *||Dec 7, 1987||Sep 20, 1988||Gutierrez Charles N||Sputum specimen collecting device|
|US4817632 *||Jun 23, 1987||Apr 4, 1989||Bioquant, Inc.||Oral fluid collection article|
|US4853325 *||Mar 26, 1986||Aug 1, 1989||Synbiotics Corporation||Saliva test for feline leukemia virus|
|US4886175 *||Apr 10, 1989||Dec 12, 1989||Merck & Co., Inc.||Bottle and cap closure system|
|US4923798 *||Mar 17, 1988||May 8, 1990||Synbiotics Corporation||Saliva test for feline leukemia virus|
|US4955745 *||Oct 5, 1989||Sep 11, 1990||Vauquelin Jeri A||Bottle with applicator|
|US5050616 *||Mar 14, 1990||Sep 24, 1991||The United States Of America As Represented By The Secretary Of The Department Of Health And Human Services||Universal collector for submandibular-sublingual saliva|
|US5076474 *||Oct 21, 1988||Dec 31, 1991||Bernd Hansen||Dropper bottle with frangible outlet element|
|US5211182 *||Oct 23, 1991||May 18, 1993||Deutsch Marshall E||Home ovulation test kit and method|
|US5246145 *||Feb 26, 1992||Sep 21, 1993||Nalge Company||Liquid dropper spout having lockable pivoted closure cap|
|US5260031 *||Feb 5, 1992||Nov 9, 1993||Saliva Diagnostic Systems, Inc.||Saliva sampling device with sample adequacy indicating system|
|US5261572 *||Jun 9, 1992||Nov 16, 1993||Plato Products, Inc.||Dropper bottle|
|US5328058 *||Sep 8, 1993||Jul 12, 1994||Nalge Company||Dropper bottle assembly with squeeze cap|
|US5334502 *||Dec 24, 1991||Aug 2, 1994||Osborn Laboratories, Inc.||Method of collecting, identifying, and quantifying saliva|
|US5339829 *||Aug 25, 1992||Aug 23, 1994||Epitope, Inc.||Oral collection device|
|US5376337 *||Jul 19, 1993||Dec 27, 1994||Seymour; Eugene H.||Saliva sampling device and sample adequacy system|
|US5380492 *||Apr 14, 1993||Jan 10, 1995||Seymour; Eugene H.||Sampling device and sample adequacy system|
|US5393496 *||Mar 24, 1992||Feb 28, 1995||Saliva Diagnostic Systems, Inc.||Saliva sampling device and sample adequacy system|
|US5479937 *||Aug 3, 1993||Jan 2, 1996||Epitope, Inc.||Oral collection device|
|US5494646 *||Jul 12, 1994||Feb 27, 1996||Seymour; Eugene H.||Sampling device and sample adequacy system|
|US5573009 *||Jun 1, 1995||Nov 12, 1996||Epitope, Inc.||Oral sample collection method|
|US5609160 *||Mar 30, 1995||Mar 11, 1997||Ortho Pharmaceutical Corporation||In home oral fluid sample collection device and package for mailing of such device|
|US5714341 *||Mar 30, 1994||Feb 3, 1998||Epitope, Inc.||Saliva assay method and device|
|US5736322 *||Feb 28, 1996||Apr 7, 1998||Epitope, Inc.||Synthetic oral fluid standard|
|US5786227 *||Feb 5, 1997||Jul 28, 1998||Biex, Inc.||Fluid collection kit and method|
|US5786228 *||Feb 5, 1997||Jul 28, 1998||Biex, Inc.||Fluid collection kit and method|
|US5830410 *||Jun 1, 1995||Nov 3, 1998||Epitope, Inc.||Oral collection device and kit|
|US5920122 *||Apr 3, 1997||Jul 6, 1999||Oki Electric Industry Co., Ltd.||Contact structure using barrier metal and method of manufacturing the same|
|US5935864 *||Oct 7, 1996||Aug 10, 1999||Saliva Diagnostic Systems Inc.||Method and kit for collecting samples of liquid specimens for analytical testing|
|US5965453 *||Jun 8, 1998||Oct 12, 1999||Charm Sciences, Inc.||Test apparatus, system and method for the detection of test samples|
|US5968746 *||Nov 26, 1997||Oct 19, 1999||Schneider; David R.||Method and apparatus for preserving human saliva for testing|
|US5981293 *||Apr 29, 1998||Nov 9, 1999||Biex, Inc.||Fluid collection kit and method|
|US5981300 *||Dec 7, 1995||Nov 9, 1999||M & M Dental-Medizin Gmbh||Test kit for analyzing body fluids and analysis method|
|US6022326 *||Oct 30, 1998||Feb 8, 2000||Lifepoint, Inc.||Device and method for automatic collection of whole saliva|
|US6102872 *||May 4, 1998||Aug 15, 2000||Pacific Biometrics, Inc.||Glucose detector and method|
|US6150178 *||Mar 24, 1999||Nov 21, 2000||Avitar, Inc.||Diagnostic testing device|
|US6223947 *||Jan 31, 2000||May 1, 2001||Byron W. Bernard||Eye dropper with illuminated tip|
|US6241689 *||May 13, 1998||Jun 5, 2001||Provalis Uk Limited||Diagnostic test apparatus|
|US6248598 *||Sep 17, 1998||Jun 19, 2001||Stuart C. Bogema||Immunoassay that provides for both collection of saliva and assay of saliva for one or more analytes with visual readout|
|US6277587 *||Nov 12, 1997||Aug 21, 2001||The Trustees Of Columbia University In The City Of New York||Method of testing for periodontal disease|
|US6277646 *||Nov 17, 1997||Aug 21, 2001||Dade Behring Inc.||Fluid specimen collecting and testing apparatus|
|US6291178 *||Aug 30, 1999||Sep 18, 2001||David R. Schneider||Method and apparatus for preserving human saliva for testing|
|US6303081 *||Apr 15, 1999||Oct 16, 2001||Orasure Technologies, Inc.||Device for collection and assay of oral fluids|
|US6372513 *||Apr 19, 2000||Apr 16, 2002||Ansys Technologies, Inc.||Device and process for lateral flow saliva testing|
|US6423550 *||Mar 30, 1995||Jul 23, 2002||Ortho Pharmaceutical Corporation||Home oral fluid sample collection device and package for mailing of such device|
|US6423559 *||Dec 13, 2000||Jul 23, 2002||Oki Electric Industry Co.||Integrated circuit and fabricating method and evaluating method of integrated circuit|
|US6440087 *||May 25, 2001||Aug 27, 2002||Choicepoint Asset Co.||Oral fluid collection device and collection method|
|US6443892 *||Sep 28, 2000||Sep 3, 2002||The United States Of America As Represented By The Secretary Of The Navy||Sweat collecting device and methods for use and detection of tampering|
|US6464939 *||Jul 6, 2000||Oct 15, 2002||Varian, Inc.||Saliva testing and confirmation device|
|US6468474 *||Jan 4, 2001||Oct 22, 2002||Varian, Inc.||Saliva testing and confirmation device|
|US6489172 *||Jan 5, 2000||Dec 3, 2002||Varian, Inc.||Saliva sampling device|
|US6887681 *||Jan 17, 2003||May 3, 2005||Neogen Corporation||Apparatus and methods for chemiluminescent assays|
|US7114403 *||May 27, 2004||Oct 3, 2006||Oakville Hong Kong Co., Ltd||Fluid collection and application device and methods of use of same|
|US20010023324 *||Apr 23, 1999||Sep 20, 2001||Allan Pronovost||Glucose detector and method for diagnosing diabetes|
|US20020004019 *||Jan 4, 2001||Jan 10, 2002||Bachand Steven S.||Saliva testing and confirmation device|
|US20020015663 *||Jul 10, 1998||Feb 7, 2002||Andrew S. Goldstein||Oral collection device and kit|
|US20020020713 *||Oct 9, 2001||Feb 21, 2002||Kis Gyorgy Lajos||Package for a pharmaceutical product and method of sterilizing the package|
|US20020085958 *||Jul 11, 2001||Jul 4, 2002||Nemcek Thomas A.||Apparatus for pretreating a sample containing an analyte|
|US20020146346 *||Apr 4, 2001||Oct 10, 2002||Forefront Diagnostics Inc.||"One-device" system for testing constituents in fluids|
|US20020150884 *||Aug 23, 2001||Oct 17, 2002||Jonathan Zmuda||Oral fluid rapid assay for hepatitis C virus (HCV) antibodies using non-antibody labeling of IgA molecules recognizing HCV peptide epitopes|
|US20020155029 *||Oct 11, 2001||Oct 24, 2002||Epitope, Inc.||Device for collection and assay of oral fluids|
|US20020192839 *||Feb 19, 2002||Dec 19, 2002||Epitope, Inc.||Collection device for single step assay of oral fluids|
|US20030064526 *||Nov 30, 2001||Apr 3, 2003||Orasure Technologies, Inc.||Sample collector and test device|
|US20030129673 *||Nov 1, 2002||Jul 10, 2003||Unlimited Pharmaceutical Deutschland Gmbh||Test apparatus for the detection of pharmacologically active compounds from saliva|
|US20030138971 *||Jan 23, 2003||Jul 24, 2003||D'aurora Vito J.||Pregnancy and sex identification test based on saliva or other bodily fluids|
|US20030175593 *||Apr 30, 2002||Sep 18, 2003||Csb Battery Co., Ltd.||Separator in lead acid battery and manufacturing method thereof|
|US20030175992 *||Oct 23, 2002||Sep 18, 2003||Anthony Toranto||Glucose assay|
|US20030175993 *||Oct 23, 2002||Sep 18, 2003||Anthony Toranto||Ketone assay|
|US20030190259 *||Oct 7, 2002||Oct 9, 2003||Alley Kenneth A.||Apparatus for sampling, storing, preserving and testing a specimen|
|US20040082878 *||Aug 7, 2003||Apr 29, 2004||Dene Baldwin||Oral fluid collection, transfer and transportation device and method|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US7794656||Apr 25, 2008||Sep 14, 2010||Quidel Corporation||Device for handling and analysis of a biological sample|
|US7837939||Aug 20, 2007||Nov 23, 2010||Alere Switzerland Gmbh||Rapid sample collection and analysis device and methods of use|
|US7871568 *||Jan 22, 2007||Jan 18, 2011||Quidel Corporation||Rapid test apparatus|
|US8071394||Jan 26, 2009||Dec 6, 2011||Alere Switzerland Gmbh||Test device for detecting an analyte in a liquid sample|
|US8871155||Nov 13, 2006||Oct 28, 2014||Alere Switzerland Gmbh||Devices for detecting analytes in fluid sample|
|US9005991||Jan 5, 2012||Apr 14, 2015||American Bio Medica Corporation||Device and method for testing biological samples|
|US9011770 *||Oct 26, 2005||Apr 21, 2015||Alere Switzerland Gmbh||Device for detecting analytes in fluid samples|
|US9121551||Jan 10, 2013||Sep 1, 2015||Panasonic Intellectual Property Management Co., Ltd.||Method for collecting droplet attached on external surface of needle into capillary tube|
|US20070092402 *||Oct 26, 2005||Apr 26, 2007||Yuzhang Wu||Device for detecting analytes in fluid samples|
|U.S. Classification||600/584, 604/318|
|International Classification||B65D81/00, A61B10/00, A61B5/00, A61M1/00, G01N33/48, G01N, G01N31/22, G01N33/487, B01L3/00|
|Cooperative Classification||A61B10/0051, A61B2010/0077, B01L3/5023, B01L3/5027, B01L2200/027, A61B10/0045, B01L3/5029, B01L2200/0605, B01L2400/0644, A61B10/007, B01L2300/0825, G01N33/48714, B01L2400/0406, A61B2010/0074|
|European Classification||B01L3/5023, G01N33/487B1, A61B10/00L|
|Feb 17, 2005||AS||Assignment|
Owner name: OAKVILLE TRADING HONG KONG LIMITED, HONG KONG
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:TUNG, HSIAOHO;WU, YUZHANG;DAI, JIELIN;AND OTHERS;REEL/FRAME:015735/0103;SIGNING DATES FROM 20050127 TO 20050211
|Feb 9, 2006||AS||Assignment|
Owner name: OAKVILLE HONG KONG COMPANY LIMITED, HONG KONG
Free format text: CHANGE OF NAME;ASSIGNOR:OAKVILLE TRADING HONG KONG LIMITED;REEL/FRAME:017246/0908
Effective date: 20041026
|Sep 4, 2009||AS||Assignment|
Owner name: INVERNESS MEDICAL SWITZERLAND GMBH,SWITZERLAND
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:OAKVILLE HONG KONG COMPANY LIMITED;REEL/FRAME:023196/0128
Effective date: 20090430