DEVICES, SYSTEMS, AND METHODS FOR DIAGNOSTIC TESTING

The present disclosure relates to devices, systems, and methods for performing diagnostic tests. The disclosed diagnostic devices are capable of performing analytic tests and communicating with a portable multifunctional device (PMD) or other computing device. Through input and manipulation of materials within the diagnostic device, a large range of tests may be performed. For example, alteration or customization of chemical components of the diagnostic device may enable many analytic applications to be provided. These analytic tests may include, but are not limited to, sensing or quantification of chemicals from sample input, whether gaseous, liquid, or otherwise, sensing or quantification of analytes, antibodies, or antigens, sensing or quantification of genetic material, or other substances.

TECHNICAL FIELD

The present disclosure is directed to devices, systems, and methods for diagnostic testing involving a computing device. More specifically, the disclosure is directed towards devices, systems, and methods for performing analytic tests with a diagnostic device that is configured to communicate with a portable multifunctional device (PMD) or other computing device.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Developments in diagnostics, smart phones, and wireless communication are converging on a new way of conducting diagnostics. Just one example of the huge role smart phones and disseminated diagnostics technology will play in our lives in the future is the multitude of medical applications that have been created to serve the growing population of smart phone users. Of the almost one million medical apps available, over 80% are geared towards exercise and biometrics. The majority of the remaining percentage comprises reference applications that are static and cannot freely accept, interpret, or give out personalized information about the user. Additionally, most patients diagnosed for a particular medical issue do not immediately have access to a tailored treatment program or to a support system surrounding that treatment. As more than 50% of Americans own a smart phone, with that number expected to exceed 60% by the end of 2014, quality healthcare in the form of powerful, simple, affordable tools on handheld or other portable computing devices may usher in a new paradigm of connection between individuals that harnesses the potential of the present digital revolution.

The present disclosure relates to devices, systems, and methods for performing diagnostic tests. As set forth in detail below, the disclosed diagnostic devices are capable of performing analytic tests and communicating with a portable multifunctional device (PMD) or other computing device. For example, in some embodiments, the coupling and/or connection between a diagnostic device and a PMD allows a user to access and utilize a multitude of rapid, user-friendly, and portable testing platforms. Further, a wide range of settings and/or testing parameters may be employed and the need for conventional analytic and diagnostic hardware and/or equipment may be minimized or negated, resulting in reduced medical costs and increased portability and accessibility of diagnostic tests.

In some embodiments, the diagnostic device comprises one or more components or elements, which may also be described as componentry. Through utilization of the components, one or more diagnostic assays or tests may be conducted. The components may include chambers or wells, channels, gates, pumps, electrical systems, electrodes, sensors, etc., and/or combinations thereof. Some components may be configured to move materials including reagents and/or samples (e.g., control samples and/or test samples) through the diagnostic device. Other components may be configured to monitor and/or measure signals (e.g., electrical signals). Other components may be configured to transfer or move signals throughout the diagnostic device.

In some embodiments, the diagnostic device may be configured to function and/or operate independently, without the need for additional external testing equipment. For example, a signal (e.g., an electrical signal) may be produced within the diagnostic device that is proportional to the present of an analyte in a sample of interest, the rate of formation of a species, and/or a combination thereof. This signal may be transmitted to and processed by a PMD and may be used to produce a test result.

In some embodiments, the systems disclosed herein may comprise an interface for user control. For example, an interface may comprise software or other graphical user interface contained within a PMD. In another embodiment, firmware or hardware, either separate from or as part of the PMD, may be utilized to allow user control of the diagnostic device.

In some embodiments, users of tools implemented on a PMD or other computing device may perform many functions, due to multiple capabilities incorporated in these tools. The PMD may be coupled to an external diagnostic device. The tools may facilitate interaction with the diagnostic device, such as collection of test results from the diagnostic device.

One function of the disclosed tools may allow a user to interact with the PMD to control an external device connected to the PMD. The external device may be a diagnostic device that functions by receiving electrical stimulus from the PMD. The electrical stimulus may power mechanical and chemical processes on the diagnostic device.

Another function of the tools may be to facilitate measurement and reception of data signals from the diagnostic device before, during, and after operation of the diagnostic device. For example, the PMD may receive data from the diagnostic device in the form of, for example, electrical signals. The data may come in the form of a rate of change in electrical signal, or may be gleaned by absolute measurement at different points throughout testing. The data may be interpreted by the PMD to represent distinct, objective test results, and these results may be displayed on the PMD, for example, for a user to view.

The disclosed tools may have capability of packaging and transmitting test results gained from the coupling of the PMD and the diagnostic device. The packaged test results may be transmitted to, for example, entities outside the PMD environment, such as statistics and/or tracking organizations, service providers, including physicians, and the like. The packaged test results data may be redacted to remove identifying information about the user. The packaged test results data may also include identifying information about the user. These test results may constitute a basis for use of information housed within the software, or connection to third parties. In other words, information may be presented to the user based on the test results.

The disclosed tools may present to a user a listing of support resources relevant to the test results, including, for example, service professionals and equipment and other suppliers. The user may be able to navigate the presented resources, searching based upon several criteria. For example, a user may filter the presented resources by proximity, and may specify an annular area (e.g., zip code and/or area code) around them (e.g., a present location, a home location, work location, etc.) from which to return resources (e.g., an area greater than a certain first distance away from a given location and within a further second distance away from the user). Users may also filter resources by quality ratings, as generated by other users.

Additional aspects and advantages will be apparent from the following detailed description of preferred embodiments, which proceeds with reference to the accompanying drawings. Embodiments disclosed in the figures are generally presented in terms of a medical diagnostic, but it will be appreciated that the disclosed embodiments may be applicable to a variety of testing applications, such as for example regulatory compliance (radioactivity levels, emission/pollution levels, HAZMAT), security (TSA explosive testing, bio surveillance, bio testing), law enforcement (breath/blood alcohol level/concentration, substance identification), etc. The scope of the present disclosure is not limited to medical diagnostic testing.

FIG. 1depicts a system100for diagnostic testing, according to one embodiment of the present disclosure. The system100may include a computing device, such as a PMD102, and a diagnostic device104configured to couple to the computing device. Through input and manipulation of materials within the diagnostic device104, a large range of tests may be performed by the system100. For example, alteration or customization of chemical components of the diagnostic device104may enable many analytic applications to be provided. These analytic tests may include, but are not limited to, sensing or quantification of chemicals from sample input, whether gaseous, liquid, or otherwise, sensing or quantification of analytes, antibodies, or antigens, sensing or quantification of genetic material, or other substances.

A user interface122may be included on the PMD102that may allow the user to control some aspects of the diagnostic device104, and may present the results or measurements obtained from the diagnostic device104to the user. This user interface122may also provide information about resources, organizations, or people to the user, which may be of interest, assistance, or support to the user in reference to and/or based on a diagnostic test result.

The PMD102may include, but is not limited to, an iPhone, an Android telephone, or another “smart” mobile telephone; an iPad, an Android tablet, or other tablet device; a computer, PDA, or portable computer (e.g. laptop), or another PMD or “smart” mobile device. In other embodiments, the PMD may be a desktop computing device. In still other embodiments, the PMD may be a customized and/or specific computing device.

The PMD102may provide a plurality of functions related to the diagnostic device104. The PMD102may control or enable operation of the diagnostic device104, either through automated phone control, manual control from the user through the PMD102, or a combination of both. The PMD102may provide power to the diagnostic device104, which may actuate the diagnostic device104, and in some instances, allow for movement of components or materials within in the diagnostic device104. For example, in some embodiments, the PMD102may 1) power and/or control fluid pump and valve systems on the diagnostic device104that may be used to control the movement of reagents, solutions, suspensions and/or other liquids on the diagnostic device104; 2) power circuitry and/or electrical systems on the diagnostic device104; 3) power a mechanism to transfer a sample such as a fluid from a sample carrier such as an absorbent swab, in some instances by squeezing; 4) provide power to resistors to create temperature changes (such as may be required for thermal cycling); 5) provide power to mix and/or rehydrate components necessary to interact to produce a measurable signal; 6) supply electricity for electrochemical detection; 7) supply power to purify suspensions through an on-device filtration process and so forth. In some embodiments, for example, electrical current may be supplied to the diagnostic device104from the PMD102through one or more connection points. Similarly, function commands and other inputs may be received by the diagnostic device104through electrical or other connections with the PMD102.

The PMD102may also control functions on a self-powered diagnostic device104or device that derives power from an external source other than the PMD102. The PMD102may house and run a software interface, which may allow the user to control aspects of the diagnostic device104, view test results, access information about resources in reference to these test results, and communicate test results and associated user information to other data collection sites or to service providers. The PMD102may receive electronic signals from the diagnostic device104related to the materials within the diagnostic device104and process these signals, and may display this processed data to the user through, for example, a user interface122.

The PMD102may include a processor110, a memory112, a display114, an input device116(e.g., a keypad, microphone, etc.), a network interface118, a power supply120(e.g., a battery), and a device interface121(e.g., a docking port or other communication coupling mechanism).

The PMD102may further include a plurality of modules or other components configured to perform a variety of functions and/or operations for diagnostic testing. The modules may be stored in the memory112, as shown inFIG. 1. In other embodiments, the modules may comprise hardware components.

The modules or components may include, but are not limited to, a user interface122, one or more test modules124, an authentication engine126, a signal reader128, an array reader130, a support network module132, a database134, a tutorial/welcome module136, a category resource engine138, a global positioning system (GPS) component140, a maps engine142, a power supply controller144, and other components.

The user interface122may present information on the display114and facilitate user input via the input device116.

The one or more test modules124may be embodied as a test engine. The one or more test modules124may generate and display (e.g., via the user interface122on the display114) instructions on procedures associated with performing a diagnostic test through a plurality of mechanisms, and may trigger other modules or components.

The authentication engine126may read unique signatures from the diagnostic device104inserted into the PMD, and may generate and display forms in which the user may add input, or which may be static forms. The authentication engine126may also trigger other modules or components.

The signal reader128may read, process, or interpret electronic signals at pins of the device interface121(or port) of the PMD102that may correspond to diagnostic information. The signal reader128may also trigger other modules or components.

The array reader130may read, process, or interpret information or data contained within arrays of data generated by other modules or components. The array reader130may also trigger other modules or components.

The support network module132may trigger and control various other modules or components that may allow the user to identify, locate, and access data describing resources contained within the support network module132and/or or third parties. The support network module132may also trigger other modules or components.

The database134may store data and/or forms in which the user may add input, or which may be static forms. The database134may also read, process, interpret, package, and transmit user input into arrays stored within application or memory112or may transmit to third parties via the internet. The database134may also trigger other modules or components.

The tutorial or welcome module136may generate and display forms in which the user may add input, or which may be static forms. The tutorial or welcome module136may also retrieve data and display data, including, but not limited to, text, images, and videos that may instruct use of (or interaction with) other modules or components. The tutorial or welcome module136may also trigger other modules or components.

The category resource engine138may generate and display forms in which the user may add input, or which may be static forms. The category resource engine138may also retrieve data and display data including but not limited to text, images, and videos. The category resource engine138may generate and display location-specific information based upon other hardware and/or software in the PMD102(e.g., such as a GPS component140). The category resource engine138may also trigger other modules or components.

The GPS component140enables capture, acquisition, and/or generation of location information.

The maps engine142may manage and present maps, for example, in connection with displaying location information generated by the GPS and/or location information of resources as specified in, for example, the database.

The power supply controller144may operate to determine and/or provide power from the power supply120to the diagnostic device104.

The diagnostic device104may provide a plurality of functions to the user. The diagnostic device104may be configured to receive a sample and run a diagnostic test on the sample. The diagnostic device104may further be configured to run a control and/or calibration test. The diagnostic device104may receive an electronic signal from electrodes or other sensor and transmit this signal to the PMD102. Furthermore, the diagnostic device104may be powered by current or a battery or fuel cell, may receive power from the PMD102, or other means to provide the energy necessary to move components and/or materials within the diagnostic device104. The diagnostic device104may further comprise an interface and/or connection system that is compatible with the PMD102.

FIG. 2depicts a diagnostic device204, according to another embodiment of the present disclosure. As shown inFIG. 2, the diagnostic device204may comprise a connector205that is configured to mate with or otherwise couple to a PMD or other computing device. For example, the connector205may be configured to mate with a computer bus, input/output port, power port, and/or other communication port of a PMD. In some embodiments, the connector205may be compatible with an input/output port on a smart phone (e.g., iPhone, Android telephone, etc.) or other smart mobile device (iPad, tablet etc.). In some embodiments, the connector205may be configured to couple with an Apple Lightning connection interface. In some embodiments, the connector205may be configured to couple with a 30-pin connection interface. In yet other embodiments, the connector205may be configured to couple with a standard or miniature universal serial bus (USB) connection interface. Electrical power, electrical signals (e.g., input/output signals), and so forth may pass between the diagnostic device204and the PMD via the connector205.

As further shown inFIG. 2, the diagnostic device204comprises a housing250, which may be referred to as a body member or casing structure. The housing250may be composed of various materials. For example, the housing may comprise polymeric materials (e.g., plastics), metallic materials, glass materials, and/or combinations thereof. Other materials may also be used.

The housing250may be configured to retain one or more components, including chambers or wells251,252,253,254, channels, gates, valves, pumps (e.g., polymer pumps, user-operated pumps, etc.), cranks, buttons, electrodes, sensors, and/or electrical systems. The components may be configured for use in performing a test, such as a diagnostic test, chemical, or compound detection test, etc. The components may be mechanical, electromechanical, electrical, magnetic, electromagnetic, chemical, fluorescent, colorimetric, and/or electrochemical in nature. The components may also be various sizes, including micro-level components and nano-level components. In some embodiments, one or more components may be molded into or otherwise integrally formed with the housing250.

The components may be configured to serve a variety of functions. In some embodiments, one or more components may be configured for use in the insertion of a test sample into the diagnostic device204. Additionally, one or more components may be configured for use in the manipulation (e.g., movement, mixing, etc.) of a test sample and/or control sample, or other material within the diagnostic device. One or more components may be configured to allow passage of test samples and/or control samples through portions of the diagnostic device. One or more components may be configured to monitor, detect, and/or measure electrical signals. One or more components may be configured to transfer electrical signals throughout the diagnostic device. In some embodiments, one or more components may also be configured to house or retain other components.

With continued reference toFIG. 2, in the illustrated embodiment, the housing250comprises four chambers251,252,253,254. The chambers251,252,253,254may be integrally formed within the housing250and may have various conformations. The chambers251,252,253,254may also serve a variety of purposes. For example, the housing250may comprise one or more reagent chambers251,252, and/or one or more sample chambers253,254. In the illustrated embodiment, the housing250comprises first and second reagent chambers251,252. The reagent chambers251,252may be configured to house, store, or otherwise retain chemical reagents. The chemical reagents may comprise liquid reagents, and may include reactants, reaction products, and/or buffer solutions.

In the illustrated embodiment, the housing250further comprises first and second sample chambers253,254. More specifically, the housing250comprises a test sample chamber254, and a control sample chamber253. The sample chambers253,254may be configured to receive a sample, including a test sample and/or a control sample. In some embodiments, the sample chambers253,254may be configured to house and/or retain the sample during a diagnostic test. In some embodiments, the sample chambers253,254may be configured to house and/or retain an electrode or other sensor through which an electrical current may be monitored, detected and/or measured during a diagnostic test. In some embodiments, the diagnostic testing substantially occurs within the sample chambers253,254.

In some embodiments, the diagnostic device204may comprise one or more components which may be stimulated to manipulate the materials within the diagnostic device204. For example, one or more components may be stimulated to regulate movement of a reagent from a reagent chamber251,252to a sample chamber253,254. The components may be electrically, chemically, and/or mechanically stimulated. For example, in some embodiments, the diagnostic device204comprises polymers and/or gels comprising electroactive polymers (EAPs), ionic polymer metal composites (IPMCs), and/or other electronically-activated materials that may expand and/or contract in response to electronic stimuli that may come from a PMD. In some embodiments, expansion and/or contraction of the electronically-activated polymers and/or gels may be utilized to transfer a reagent from a reagent chamber251,252to a sample chamber253,254. In some embodiments, the expansion and/or contraction of the electronically-activated polymers and/or gels may be utilized to mix or otherwise manipulate the materials within the diagnostic device204, for example, to initiate a diagnostic testing sequence. In some embodiments, the electronically-activated polymers and/or gels may be referred to as polymer pumps.

The diagnostic device204may comprise one or more manually stimulated and/or user-operated components, including pumps, cranks, and/or buttons. The user-operated components may be utilized to transfer a reagent from a reagent chamber251,252to a sample chamber253,254. The user-operated components may further be utilized to mix or otherwise manipulate materials within the diagnostic device, for example, to initiate a diagnostic testing sequence. Through user-operated components, a user may generate the forces needed for input of materials into the device and also manipulate materials within the device. In some embodiments, a combination of one or more polymer pumps and one or more user-operated components may be used.

The polymer pumps and/or user-operated components may be disposed in a reagent chamber251,252, sample chamber253,254and/or other areas within the diagnostic device204. For example, in some embodiments, a reagent chamber251,252may be configured to house or retain a polymer pump that is configured to push, move or otherwise force a reagent from the reagent chamber251,252and into a sample chamber253,254. The reagent, once pushed into the sample chamber253,254, may initiate a biochemical process resulting in the analysis of a sample. In some embodiments, the sample may be disposed on a test sample carrier280and/or a control sample carrier260. In some embodiments, the sample carrier260,280may comprise an absorbent swab.

In some embodiments, one or more polymer pumps and/or user-operated components may be configured to manipulate and/or move a reagent comprising an buffer solution, which may also be referred to as an eluent buffer solution, eluent buffer, eluent solution, solvent solution, etc. For example, polymer pumps and/or user-operated components may force a buffer solution through one or multiple channels or passageways within the diagnostic device204. For example, a buffer solution may be moved from a reagent chamber251,252to a sample chamber253,254via one or more channels. In some embodiments, the buffer solution may be configured to elute a sample contained within and/or on a sample carrier280. For example, a buffer solution may be used to elute a sample contained within an absorbent swab of a sample carrier280. Once eluted, the sample may interact with one or more components contained within the sample chamber253,254, including sensors, capture probes and/or electrodes during a diagnostic analysis. The buffer solution may also be used to rehydrate a sample within the sample chamber253,254. In some embodiments, the sample chamber253,254may also contain electronically-activated polymers or other gels, which may be stimulated to expand and/or contract in order to mix the contents of the sample chamber253,254, which may include the buffer solution and the sample. The sample chamber253,254may further contain and/or be surrounded by other components which may be configured to alter the conditions of the chamber253,254, such as but not limited to temperature, pressure, or other conditions.

As shown inFIG. 2, the diagnostic device204further comprises one or more sample introduction ports255which may be disposed within the housing250. A sample introduction port255may be configured to receive a test sample such as a gaseous, liquid, fluid, or solid test sample. In some embodiments, the sample introduction port255is configured to receive a test sample that is disposed on a sample carrier280. For example, the sample introduction port255may be configured to receive an absorbent swab. The sample introduction port255may also be configured to receive a test tube or other sample container. In some embodiments, the sample introduction port255may be in communication with a test sample chamber254. Once the test sample is positioned within the test sample chamber254, a diagnostic test sequence may be initiated, which may include movement of a reagent from a reagent chamber251,252into the sample chamber253,254via, for example, one or more polymer pumps.

In some embodiments, the sample introduction port255may be configured to be sealed after insertion of the sample carrier280. For example, the sample introduction port255may comprise a pliable and/or deformable seal through which a sample carrier280may be inserted. In some embodiments, a lid that may be made of the same material as the diagnostic device204(or any another material) may close to form a seal around the sample carrier280. Other methods of sealing the sample carrier280within the sample diagnostic device204may also be used. Once sealed, the sample carrier280may be held in place by the seal and/or the channel or passageway267, which leads to a test sample chamber254. The sample carrier280may provide a means of transporting a plurality of samples through this channel or passageway, to undergo a plurality of diagnostic tests once inserted.

In some embodiments, the diagnostic device200may be configured to be a consumable device. For example, the diagnostic device200may be a single use device, or a device configured for limited use (e.g., 2 uses, 3 uses, 4 uses, 5 uses, etc.) In other embodiments, the diagnostic device200is configured as a non-consumable device that can be reused as desired.

Various detection methods may be employed by the diagnostic device204. In some embodiments, electrochemical detection methods may be employed. In some embodiments, for example, the diagnostic device204comprises a reagent that may be disposed within the reagent chambers251,252. The reagent may comprise redox conjugate compounds. Other compounds that may bind chemical entities of interest in the sample may also be used. Illustrative redox conjugate compounds may include conjugates such as ferrocene, an HRP/H2O2/hydroquinone system, or another redox system or organometallic compound. The reagent may further comprise a chemical buffer in which samples, redox conjugate compounds, and/or other reagent compounds may dissolve.

Upon initiation of a diagnostic test sequence, the reagent may be transferred from the reagent chamber251,252to the sample chambers253,254for example, via one or more polymer pumps. The sample chambers253,254may comprise a system by which presence of a chemical entity creates an increase or decrease in electrical signal, which may be accomplished by the presence of a chemical capture probes bound to one or more electrodes or sensors. The capture probes may bind the reagent (e.g., a reagent comprising a redox conjugate compound), the chemical entity of interest, or a combination thereof, which may cause either an increase in the transfer of electrons to the electrode or sensor, a decrease in the transfer of electrons to the electrode or sensor, or a combination thereof. This “molecular wire” system may include, but is not limited to, the chemical entity of interest, the reagent (e.g., a reagent comprising redox conjugate compounds), capture probes, or other compounds known to one of ordinary skill in the art.

The increase or decrease in electrical signal may be transferred down through this “molecular wire” to the electrodes or sensors, which may pass the electronic signal to a PMD either wirelessly or through one or more wires. The signal may be quantified through measurement by a voltmeter, an ammeter, or another electronic measurement device located on the diagnostic device204or elsewhere, and may be processed by the PMD, and then may be displayed to the user, optionally in a plurality of formats, to provide information about the contents of the test sample.

In some embodiments, the electrode or other sensor may be bound and/or coupled to capture probes, which may comprise a peptide and/or another chemical entity. The chemical entity may allow indirect and/or direct binding of the peptide to the electrode. For example, the chemical entity may comprise a thiolated hydrocarbon chain, which may be bound to the N-terminus of a peptide. The C-terminus of the peptide may be modified and bound with a plurality of chemical agents, including but not limited to a redox agent such as methylene blue. In some embodiments, the peptide may have a chemical affinity for one or multiple entities in the sample solution. When there is no bond between these entities and the peptide, the peptide may be highly flexible, and may efficiently achieve electron transfer to and from the redox agent. When there is a bond between these entities and the peptide, the peptide may become less flexible, and, in binding this entity, may lose the ability or efficiency of electron transfer to and from the redox agent through a plurality of mechanisms, including, but not limited to, being physically and chemically obstructed by the bound entity, or moved a sufficient distance away from electrode. In some embodiments, the diagnostic device204also comprises a solution that is capable of unbinding the peptide from the entity.

In other embodiments, the electrode may comprise a DNA sensor such as, in some embodiments, an aptamer. In such embodiments, the electrical conductivity of DNA and/or other oligonucleotide constructs is dependent on its conformational state. For example, upon binding or otherwise incorporating an analyte from a sample, the conformation of the DNA sensor may switch, thereby resulting in an altered conductive path between two oligonucleotide stems. An electrode or other sensor may be used to monitor the electron transfer. This methodology electrochemical detection is further described in U.S. Pat. Nos. 7,947,443 and 7,943,301, each of which is incorporated by reference.

In other embodiments, the detection method may comprise colorimetry and/or fluorimetry. For example, the diagnostic device200may comprise a colorimeter and/or a fluorometer. The colorimeter and/or fluorometer may be coupled to other components within the diagnostic device200, and may be used to analyze various sample types.

FIGS. 3A and 3Bdepict an illustrative representation of electrochemical detection, according to another embodiment of the present disclosure. In particular,FIGS. 3A and 3Bdepict an electrode270that may be configured to measure the transfer of electrons during a diagnostic test. Referring both to the diagnostic device204shown inFIG. 2and to structural diagrams shown inFIGS. 3A and 3B, in some embodiments, the diagnostic device204may be sensitized to a specific diagnostic species as a consequence of the biochemical components immobilized or contained with the sample chambers253,254. For example, for a HIV test, HIV-specific peptides or proteins are immobilized to an electrode270that is disposed in the bottom of sample chambers253,254. In one embodiment, the HIV-specific peptide or protein271changes conformation upon binding a HIV antibody in the patient or control sample that is introduced via the sample carrier260,280from an amorphous structure to a polypeptide chain with defined structure (such as a alpha helix or beta strand or beta sheet). Bound to this peptide is a redox-sensitive moiety272that when attached to the amorphous peptide, demonstrates a very high electron transfer rate (high kET) in communication with the PMD. Upon antibody binding, the redox-sensitive moiety moves away from the electrode and the kETis dramatically reduced. For example, as shown inFIGS. 3A and 3B, distance D2is greater than distance D1. As a consequence of the change in kETas detected by the PMD, this mechanism can be utilized for quantifying antibodies in a patient sample.

FIGS. 28A and 28Bdepict an illustrative representation of electrochemical detection, according to another embodiment of the present disclosure. In particular,FIG. 28Adepicts the sensor system2345ain an unbound state (first conformational state), andFIG. 28Bdepicts the sensor system2345bin a bound state (second conformational state). As shown inFIGS. 28A and 28B, a first oligonucleotide stem2331a,2331band a second oligonucleotide stem2333a,2333bare connected together at a junction2341a,2341b.Stems2331a,2331b,2333a,2333bmay comprise double helical DNA, or other nucleic acid constructs. The sensor system2345a,2345bmay further comprise a third oligonucleotide stem2335a,2335b.The sensor system2345a,2345bfurther comprises a receptor2337a,2337b,which may form part of the junction2341a,2341b.The receptor2337a,2337bmay comprise a nucleic acid aptamer sequence selected to bind to a target analyte.

In the illustrated embodiment, first stem2331a,2331bfunctions as an electron donor and second stem2333a,2333bfunctions as an electron sink (although the reverse configuration may also be employed). When an analyte2339a,2339bbinds to a receptor2337a,2337b,a conformation change in the sensor system2345a,2345boccurs, resulting in a detectable change in charge transfer between the first and second stems2331a,2331b,2333a,2333b.The conformational change may consist of adaptive folding, compaction, structural stabilization or some other steric modification of junction in response to analyte2339a,2339bbinding which causes a change in the charge transfer characteristics of the sensor system2345a,2345b.

As further illustrated inFIGS. 28A and 28B, in some embodiments, the sensor system2345a,2345bmay comprise a charge flow inducer2343a,2343b,which may comprise antraquinone (AQ) or rhodium (III) complexes with aromatic ligands, for controllably inducing charge transfer between first and second stems2331a,2331b,2333a,2333bin the second conformational state. Additionally, the sensor system2345a,2345bmay be coupled to or otherwise attached to an electrode2370a,2370bthat is disposed within a sample chamber of the diagnostic device. This methodology electrochemical detection is further described in U.S. Pat. Nos. 7,947,443 and 7,943,301, each of which is incorporated by reference.

FIGS. 29A and 29Bdepict an illustrative representation of electrochemical detection, according to another embodiment of the present disclosure. In particular,FIG. 29Adepicts the sensor system2445ain an unbound state (first conformational state), andFIG. 29Bdepicts the sensor system2445bin a bound state (second conformational state). As shown inFIGS. 29A and 29B, a first oligonucleotide stem2431a,2431band a second oligonucleotide stem2433a,2433bare connected together at a junction2441a,2441b.The sensor system2445a,2445bfurther comprises a receptor2437a,2437b,which may form part of the junction2441a,2441b.

In the illustrated embodiment, first stem2431a,2431bfunctions as an electron donor and second stem2433a,2433bfunctions as an electron sink (although the reverse configuration may also be employed). When an analyte2439a,2439bbinds to a receptor2437a,2437b,a conformation change in the sensor system2445a,2445boccurs, resulting in a detectable change in charge transfer between the first and second stems2431a,2431b,2433a,2433b.For example, prior to the binding of the analyte2439a,2439b,charge transfer between first and second stems2431a,2431b,2433a,2433bmay be substantially impeded.

As further illustrated inFIGS. 29A and 29B, in some embodiments, the sensor system2445a,2445bmay comprise a charge flow inducer2443a,2443bfor controllably inducing charge transfer between first and second stems2431a,2431b,2433a,2433bin the second conformational state. Additionally, the sensor system2445a,2445bmay be coupled to or otherwise attached to an electrode2470a,2470bthat is disposed within a sample chamber of the diagnostic device. This methodology electrochemical detection is further described in U.S. Pat. Nos. 7,947,443 and 7,943,301, each of which is incorporated by reference.

FIG. 4depicts a diagnostic device304according to another embodiment of the present disclosure. As shown inFIG. 4, the diagnostic device304may comprise a housing350that that comprises first and second sample chambers353,354. In some embodiments, the diagnostic test sequence may comprise a multi-step ELISA type reaction in which a series of biochemical and wash reagents are added to sample chambers353,354. Test samples and/or control samples may be introduced to the diagnostic device304via sample introduction ports355,356. The test samples and/or control samples may thereafter be introduced into the sample chambers353,354, for example, via a reagent comprising a reaction buffer contained within one or more buffer chambers356. A biochemical reagent, such as an unlabeled peptide (271ofFIGS. 3A and 3B) or DNA sensor may be contained with a reagent chamber351,352and pumped into the sample chambers353,354at the appropriate step in the analytical reaction sequence. This step may be followed by a subsequent step of adding an electrochemical modulator such as ferrocene from yet another chamber,357. In some embodiments, waste may be collected in a waste chamber358.

FIGS. 5A,5B, and5C depict a diagnostic device404according to another embodiment of the present disclosure. As shown inFIG. 5A, the diagnostic device404may comprise a plurality of reagent chambers451,452. In some embodiments, the reagent chambers451,452may be configured to accommodate polymer pumps. In the illustrated embodiment, the reagent chambers451,452are in fluid communication with the sample chambers453,454. In particular, a first reagent chamber451is in fluid communication with the control sample chamber453via a channel or passageway461. A second reagent chamber452is in fluid communication with the test sample chamber454via a second channel or passageway462. The channels461,462may allow for passage of reagents including elution buffers and/or other solutions between the reagent chambers451,452and the sample chambers453,454.

The diagnostic device404further comprises a control sample carrier460. The control sample carrier460may comprise an absorbent swab comprising a control sample. As shown in the illustrated embodiment, the control sample carrier460may be coupled, affixed, embedded, or otherwise attached to a sidewall of the control sample chamber453.

The diagnostic device404further comprises a sample introduction port455that is in fluid communication with the test sample chamber454. The sample introduction port455may be configured to receive a test sample carrier, and may allow for insertion of the test sample carrier into the test sample chamber454.

FIG. 5Bdepicts the diagnostic device404ofFIG. 5Aaccording to another embodiment of the present disclosure. As shown inFIG. 5B, the housing450may comprise a solid lid463or other type of covering.FIG. 5Cdepicts the diagnostic device ofFIGS. 5A and 5Bwherein a test sample carrier480has been inserted into the sample introduction port455.

FIGS. 6A,6B, and6C depict a system500for diagnostic testing, according to another embodiment of the present disclosure. In the illustrated embodiment, the system500comprises a PMD502coupled to a diagnostic device504. The diagnostic device504may be coupled to the PMD502in various ways. As shown in the illustrated embodiment, the diagnostic device504may be coupled to the PMD502via a wired or physical connection, which may be referred to as a physical connecting mechanism. In such embodiments, the PMD502may comprise a coupling interface. In some embodiments, the coupling interface may comprise a computer bus, input/output port, power port, and/or other communication port. The diagnostic device504may comprise a complimentary connector505that is configured to mate with the coupling interface of the PMD502. For example, in the illustrated embodiment, the PMD502is coupled to the diagnostic device504via a connector505that is configured to mate with the PMD502. The connector505may comprise one or more wires and/or other communication protocols that are necessary for the facilitation and transfer of electrical signals (e.g., digital data and/or power) between the PMD502and the diagnostic device504. Various types of connectors505may be used.

The wired connection may be established by direct connection of the diagnostic device504to the PMD502via one or more wires, wire cables, and/or other physical devices (e.g., connectors, etc.). In some embodiments, the diagnostic device504is coupled to a docking port and/or other communication port of the PMD502. In other embodiments, the PMD502and the diagnostic device504may be coupled via one or more intermediate devices.

In other embodiments, the diagnostic device504may be coupled to the PMD502via a wireless connection, which may be referred to as a virtual connection mechanism. For example, the diagnostic device504may be coupled to the PMD502through one or more wireless networks and/or through local signaling from the PMD502to the diagnostic device504. The diagnostic device104may be coupled to the PMD502via Bluetooth or other wireless communication protocols, or via any area network, whether local or otherwise.

In the illustrated embodiment, the diagnostic device505comprises a housing550and an electrical system590disposed within the housing550. The diagnostic device505further comprises first and second reagent chambers551,552, a control sample chamber553, and a test sample chamber554, each of which is disposed within the housing550. The diagnostic device505further comprises a first polymer pump565and a second polymer pump566disposed within the first and second reagent chambers551,552respectively. In some embodiments, the polymer pumps565,566may be electrically actuated and/or activated, via, for example, an electrical signal originating from the PMD502. The diagnostic device505further comprises electrodes570disposed within the sample chambers553,554.

The electrical system590may comprise hardware, software, standard electrical components and/or circuitry, and one or more processors and/or microprocessors. The electrical system590may be electrically coupled to the connector505via one or more wires564or other electrical pathway. The electrical system590may also be electrically coupled to the polymer pumps565,566and electrodes570. For example, the electrical system590may be electrically coupled to the polymer pumps565,566via one or more wires593,594or other electrical pathways. Similarly, the electrical system590may be electrically coupled to the electrodes570via one or more wires591,592or other electrical pathways.

In some embodiments, the electrical system590may be configured to send electrical signals to and/or receive electrical signals from the PMD502. The electrical system590may further be configured to send electrical signals to and/or receive electrical signals from various components within the diagnostic device504. For example, the electrical system590may send electrical signals to one or more polymer pumps551,552which may actuate the polymer pumps551,552. The electrical system590may also receive electrical signals from the electrodes570or other sensors. In some embodiments, the electrical system590may further be configured to process electrical signals either from the PMD502, or from one or more components within the diagnostic device504.

FIG. 6Bdepicts the system500ofFIG. 6Acomprising a PMD502coupled to a diagnostic device504. Additionally,FIG. 6Billustrates a sample carrier580prior to being introduced into the diagnostic device504.FIG. 6Cdepicts the system500ofFIG. 6Aafter a sample carrier580has been introduced into the diagnostic device504. As shown inFIG. 6A, the sample carrier580has been inserted into the diagnostic device504such that it is partially disposed over the sample test chamber554and an electrode570. Following insertion of the sample carrier580, a diagnostic test may be initiated, for example, via a signal from the PMD502.

FIGS. 7A,7B, and7C depict several sample carriers680,780,880that may be used according to various embodiments of the present disclosure. For example, inFIG. 7A, the sample carrier680comprises an absorbent swab681coupled to a handle, stick, or shaft682. In some embodiments, the absorbent swab681may be a flocked swab comprising nylon. Other absorbent materials may be used. The absorbent swab618may be configured to absorb a sample prior to delivery to a diagnostic device. The absorbent swab681may thereafter be inserted into a diagnostic device. In some embodiments, a buffer solution contained within the diagnostic device may be used to elute the sample from the absorbent swab681following insertion of the sample carrier680into the diagnostic device. In other embodiments, one or more components of the diagnostic device may be configured to squeeze and/or otherwise release the sample from the absorbent swab681and into a test sample chamber of the diagnostic device.

In some embodiments, the sample carrier680may be disposed within a container648. The container648may be at least partially filled with a buffer solution or other solvent. As shown in the illustrated embodiment, the container684may comprise a test tube686and a cap685. The cap685may be configured to seal or close the test tube686either reversibly, or irreversibly. In some embodiments, the cap685may be screwed or twisted onto the test tube686. In other embodiments, the cap685may be snapped onto the test tube685via a snap fit connection.

The buffer solution within the container648may be configured to elute the sample out of the sample carrier680. For example, the buffer solution within the container648may elute the sample out of the absorbent swab681following insertion of the sample carrier680into the container648. The elution may occur prior to and/or during a diagnostic test.

In some embodiments, the container684may be configured for use without a separate sample carrier. For example, a solid sample may be disposed and dissolved in the buffer solution within the container684. The container684may thereafter be introduced to a diagnostic device and an analysis of the sample may be performed.

FIG. 7Bdepicts a sample carrier780according to another embodiment of the present disclosure. As shown inFIG. 7B, the sample carrier780may comprise a capillary tube787. As indicated by the reference arrow, a fluid sample may be drawn into the capillary tube787and collected via capillary action. A solid sample may also be collected in the capillary tube787, if desired. In some embodiments, the capillary tube787may be disposed into a container comprising a buffer solution (such as the container684depicted inFIG. 7A) prior to being delivered to a diagnostic device. In other embodiments, the capillary tube787may be delivered directly to a diagnostic device for diagnostic testing.

FIG. 7Cdepicts yet another embodiment of a sample carrier880according to the present disclosure. As shown inFIG. 7C, in some embodiments, the sample carrier comprises a handle882and a terminating loop883. The loop883may collect a plurality of samples (e.g., fluid and/or solid samples). In some embodiments, the loop883may be disposed into a container comprising a buffer solution (such as the container684depicted inFIG. 7A) prior to being delivered to a diagnostic device. In other embodiments, the sample carrier880comprising the loop883may be delivered directly to a diagnostic device for diagnostic testing.

FIG. 8depicts a diagnostic device904according to another embodiment of the present disclosure. In the illustrated embodiment, the diagnostic device904is configured to receive a container984within which a test sample may be disposed or dissolved. As previously discussed, in some embodiments, a sample carrier may be disposed within the container984; and in other embodiments, the container984may independently function as the sample carrier.

As shown inFIG. 8, in some embodiments, the container984may comprise a test tube986that comprises one or more threads988. The threads988may be disposed along a portion of the outer periphery of the test tube986. The threads988may be configured to engage with complimentary threads disposed around the sample introduction port955. In such embodiments, the container984may be coupled to the diagnostic device904via a threaded engagement.

The diagnostic device904may further comprise a puncturing device959. The puncturing device959may be disposed near the sample introduction port955, and may be configured to puncture or rupture a wall of the container984. After a wall of the container984is ruptured, the buffer solution from within the container984(including a test sample) may be dispensed out of the container984and into the diagnostic device. For example, the buffer solution comprising a test sample may be dispensed directly, or through one or more channels, into a test sample chamber wherein a diagnostic test may be performed. In the illustrated embodiment, the puncturing device959is configured to rupture a bottom wall of the container984as the container984is twisted (i.e., threaded) inwardly through the sample introduction port955.

FIG. 9depicts a diagnostic device1004according to another embodiment of the present disclosure. In the illustrated embodiment, the diagnostic device1004is configured to receive a container1084within which a test sample may be disposed or dissolved. As previously discussed, in some embodiments, a sample carrier may be disposed within the container1084; and in other embodiments, the container1084may independently function as the sample carrier.

As shown inFIG. 9, in some embodiments, the container1084may comprise a test tube1086. In some embodiments, a fitting or ring1089may be disposed around the outer periphery of a portion of the test tube1086. The test tube1086, or the fitting1089on the test tube1086, may be configured to engage with the outer walls of the sample introduction port1055. In such embodiments, the container1084may be coupled to the diagnostic device1004via this engagement such that the container1084is not easily removable. In other embodiments, the sample introduction port1055may comprise a polymeric ring1089or other component that may be configured to retain a container1084that has been inserted into the diagnostic device1004.

The diagnostic device1004may further comprise a puncturing device1059. The puncturing device1059may be disposed near the sample introduction port1055, and may be configured to puncture or rupture a wall of the container1084. After a wall of the container1084is ruptured, the buffer solution from within the container1084(including a test sample) may be dispensed out of the container1084and into the diagnostic device. For example, the buffer solution comprising a test sample may be dispensed directly, or through one or more channels, into a test sample chamber wherein a diagnostic test may be performed. In the illustrated embodiment, the puncturing device1059is configured to rupture a bottom wall of the container1084as the container1084is slid or otherwise inserted inwardly through the sample introduction port1055.

FIGS. 10A-10Cdepict a sample carrier1180being inserted into a diagnostic device1104according to another embodiment of the present disclosure. As shown inFIGS. 10A-10C, a container1184containing a test sample may be slid or otherwise inserted inwardly through a sample introduction port1155, as indicated by the reference arrow ofFIGS. 10A and 10B.FIG. 10Cillustrates the puncturing device1159rupturing through the bottom wall of the container1184, which may cause the contents of the container1184, including a buffer solution and test sample, to be dispensed into the diagnostic device1104.

FIGS. 11A and 11Bdepict a sample carrier1280, according to another embodiment of the present disclosure. As shown inFIGS. 11A and 11B, the sample carrier1280may comprise an absorbent swab1281which may be inserted into a container1284. The container1284may comprise a test tube1286and a cap1285. The container1284may also be at least partially filled with a buffer solution1268. As illustrated inFIG. 11B, the absorbent swab1281may disposed within the container1284such that the absorbent swab1281is immersed in the buffer solution1268. Immersing the absorbent swab1281into the buffer solution may cause the sample to elute from the absorbent swab1281and into the buffer solution. The buffer solution, comprising the sample, may thereafter be dispensed to the diagnostic device.

FIGS. 12A-12Cdepict a sample carrier1380according to another embodiment of the present disclosure. As shown inFIGS. 12A-12C, the sample carrier1380may comprise an absorbent swab1381and a handle1382. The sample carrier1380may be inserted into a container1384comprising a test tube1386and a cap1385. The container1384is also at least partially filled with a buffer solution1368.

InFIG. 12A, the container1384is depicted in an open configuration in which the cap1385is removed and the test tube1386is open. While the container1384is in the open configuration, the sample carrier1380may be inserted into the test tube1386, as indicated by the reference arrow. InFIG. 12B, the container1384is depicted in an open configuration and the sample carrier1380is partially disposed within the test tube1386and the buffer solution1368. Further, a portion of the handle1382is shown protruding outwardly from the test tube1386. In some embodiments, this protruding portion may be broken or otherwise removed from the sample carrier1380so that the cap1385can be used to close or seal the test tube1386, as shown inFIG. 12C. InFIG. 12C, the container1384is depicted in a closed configuration in which the cap1385has been used to close or seal the test tube1386. The protruding portion of the handle1382has been broken and removed from the sample carrier1380, and the absorbent swab1381remains disposed and immersed within the buffer solution1368inside of the test tube1386.

FIGS. 13A-13Cdepict a sample carrier1480according to another embodiment of the present disclosure. As shown inFIGS. 13A-13C, the sample carrier1480may comprise an absorbent swab1481and a handle1482. The sample carrier1480may be inserted into a container1484comprising a test tube1486and a cap1485. The container1484is also at least partially filled with a buffer solution1468.

In the illustrate embodiment, the container1484further comprises a flexible membrane1469through which the sample carrier1480may be inserted. The flexible membrane1469may be disposed within the cap1485or within the test tube1486. InFIG. 13A, the flexible membrane1469is closed and the sample carrier1480has not yet been inserted through the flexible membrane1469. As indicated by the reference arrow, a user may insert the sample carrier1480inwardly into the test tube1486of the container1484and into the buffer solution1468.

InFIG. 13B, the sample carrier1480has been partially inserted through the flexible membrane1469. As indicated by the reference arrow, the sample carrier1480may be further inserted inwardly into the test tube1486of the container1484and into the buffer solution1468. InFIG. 13C, the sample carrier1480has been inserted into the test tube1486and the buffer solution1468. As further shown inFIG. 13C, the flexible membrane1469, may close to form a seal around the handle1482of the sample carrier1480thereby preventing the buffer solution1468from exiting the container1484via the flexible membrane1469.

FIGS. 14A-14Cdepict a sample carrier1580, according to another embodiment of the present disclosure. As shown inFIGS. 14A-14C, the sample carrier1580may be inserted into a container1584comprising a test tube1586that is at least partially filled with a buffer solution1568. The container1584may further comprise a barrier1575or membrane that is configured to retain the buffer solution within a portion of the container1584. InFIG. 14A, for example, the buffer solution1568is retained within a portion of the container1584that is away from the electrode1570or sensor, such that the buffer solution1568is prohibited from contacting the electrode1570or sensor until the desired time during the diagnostic test. As indicated by the reference arrow, the sample carrier1580may be inserted inwardly into the test tube1586and buffer solution1568.

InFIG. 14B, the sample carrier1580has been inserted into the test tube1586and buffer solution1568. The barrier1575remains intact and the buffer solution1568is still prohibited from contacting the electrode1570or sensor. With the sample carrier1580disposed or dissolved within the buffer solution, the sample may be eluted into the buffer solution. As indicated by the reference arrow, the user may further insert the sample carrier1580to break or rupture the barrier1575at the desired moment.

InFIG. 14C, the sample carrier1580has been forced through the barrier1575such that the barrier1575has been broken or ruptured. Once the barrier1575is broken, the buffer solution1568comprising the sample may be dispensed directly, or through one or more channels, to the electrode1570or sensor and a diagnostic test may be performed.

FIGS. 15A-15Cdepict a system1600for diagnostic testing, according to another embodiment of the present disclosure. As shown in the illustrated embodiment, the system1600comprises a PMD1602coupled to a diagnostic device1604. The diagnostic device1604comprises a housing1650which includes a cover1663. The housing1650further comprises a sample introduction port1655.

In some embodiments, the housing1655may further comprise one or more indicators1676. The indicator1676may comprise a light indicator, such as an LED indicator. The indicator1676may be configured to change colors and/or blink to provide the user with helpful information. For example, in some embodiments, the indicator1676may indicate whether the PMD1602is properly coupled to the diagnostic device1604. In other embodiments, the indicator1676may indicate whether the diagnostic device1604is in a powered on or off mode. In other embodiments, the indicator1676may indicate the status of the diagnostic test, including whether a test is ready to begin, is currently being run, or has been completed. In other embodiments, the indicator1676may be configured to prompt a user to take or perform an action. In other embodiments, the indicator1676may indicate the results of a test (e.g., a certain color may indicate a positive test result, while a different color may indicate a negative test result).

InFIG. 15B, the system1600is depicted prior to performing a diagnostic test. In particular, a sample carrier1680is depicted prior to being inserted into the diagnostic device1604. InFIG. 15C, the sample carrier1680has been inserted into the diagnostic device1604via the sample introduction port1655.

FIG. 16depicts a system1700for diagnostic testing, according to another embodiment of the present disclosure. As shown in the illustrated embodiment, the diagnostic system1700may comprise a PMD1702and a diagnostic device1704. As further shown in the illustrated embodiment, the PMD1702may be wirelessly coupled to the diagnostic device1704.

The diagnostic device1704comprises a housing1750which includes a cover1763. The diagnostic device further comprises a sample introduction port1755and one or more indicators1777,1778. As previously mentioned in relation toFIGS. 15A-15C, various types of indicators may be used.

FIGS. 17A-17Cdepict systems1800,1900,2000for diagnostic testing, according to other embodiments of the present disclosure. As shown inFIGS. 17A-17C, in some embodiments, the diagnostic device1804,1904,2004may be configured to operate as a docking station for the PMD1802,1902,2002. The docking station diagnostic device1804,1904,2004may also be configured to charge the PMD1802,1902,2002.

InFIG. 17A, the diagnostic device1804comprises a sample introduction port1855which is disposed on a forward facing surface of the diagnostic device1804. InFIG. 17B, the sample introduction port1955is disposed on a top wall or upper facing surface of the diagnostic device1904.FIG. 17Bfurther depicts a test sample chamber1954, which may be in fluid communication with the sample introduction port1955. The test sample chamber may be wholly, or partially, disposed within the diagnostic device1904. InFIG. 17C, the sample introduction port2055is disposed on a forward facing surface of the diagnostic device2004. The sample introduction port2055is also disposed such that it is adjacent to the PMD2002.FIG. 17Cfurther depicts a sample carrier2080partially disposed within the sample introduction port2055.

A variety of systems and methods, including software implemented methods are also disclosed herein. For example, in utilizing the devices and systems disclosed herein the user may download software to the PMD. The software may provide a general operating interface for the diagnostic assay. In some embodiments, the general operating interface may be modified or supplemented by diagnostic analyte specific parameters. For example, in some embodiments, diagnostic analyte specific parameters may be derived from an external analytical sample processor and/or sensor. In other embodiments, the diagnostic analyte specific parameters may be derived from downloadable software, a barcode, or a QS tag. In yet other embodiments, the analyte specific parameters may be manually inserted.

The methods disclosed herein may be user-friendly. For example, the general and/or analyte specific diagnostic testing interface may enable a user, whether or not they are trained in laboratory assay methods, to perform a diagnostic test which may produce a test result that will be viewable on the PMD.

In some embodiment, the results of the diagnostic test may be transmitted and/or communicated to other entities. For example, the results of the diagnostic test may be transmitted to a centralized databank, a central computer in a hospital, one or more physicians or professionals who are skilled in interpreting the test results, or one or more physicians or professionals who may provide professional care in response to certain diagnostic test results. The results of the diagnostic test may also be transmitted to federal agencies such as the center for disease control (CDC) for disease epidemiological purposes, social networks, or companies that may provide products and/or services relating to the test results which may include companion pharmaceutical medications related to a particular diagnostic test. The results of the diagnostic test may also be transmitted to counselors (e.g., crisis intervention counselors for sexually transmitted diseases (STDS), pregnancy counselors, cancer counselors, etc.), geotagged resources, or other connections.

The present disclosure also relates to an interface, software environment, or other system for posting, rating, browsing, selling, purchasing, and managing of a plurality of diagnostic devices and/or the software applications that support and relate to the disclosed systems. The diagnostic devices may be designed for use through a plurality of mechanisms with the PMD on which the interface or system is housed. A user may access this system through the use of a plurality of PMDs, and may operate the diagnostic device through interaction with this interface or system.

In some embodiments, the system may be linked to an online server allowing communication between the PMD and the Internet, and may facilitate payment for and delivery of the diagnostic devices and associated software applications, transmission of data between the PMD and the server, communication for updates of content on either the online server or the PMD, and/or communication for other purposes.

The system may also provide a means by which the diagnostic devices may be controlled or manipulated by electrical signals from the PMD. The electrical signals may be caused by user-interaction with the system or may be automated as part of the system or software procured through the system.

FIG. 18is a flow chart illustrating an exemplary process2100of interaction between a diagnostic device and a PMD. As shown inFIG. 18, a user may supply2110a test sample to a sensing portion of a diagnostic device. A PMD may supply inputs2120to the diagnostic device, such as electrical power to run components or circuitry (i.e. pumps, sensor, transducers, etc.) and to control the function of the diagnostic device and any or all components thereof. The PMD may further read an output2130from the diagnostic device and display2140a user-readable response to the output.

FIG. 19is a flow chart illustrating another exemplary process2200of interaction between a diagnostic device and a PMD. As shown inFIG. 19, a user may supply2210a test sample to a sensing portion of a diagnostic device. A PMD may supply inputs2220to the diagnostic device, such as electrical power to run components or circuitry (i.e. pumps, sensor, transducers, etc.) and to control the function of the diagnostic device and any or all components thereof. The PMD may further read an output2230from the diagnostic device and display2240a user-readable response to the output. In some embodiments, one or more pumps may be actuated by the PMD to pump reagents2222and/or electro-chemical modulators2224into sample chambers which may be used in the diagnostic test.

FIG. 20depicts a flow diagram of a method2300for preparing for diagnostic testing, according to one embodiment of the present disclosure. The method2300may be performed and/or facilitated by tools, or an application comprising a plurality of tools, implemented on a PMD, or other computing device. The PMD may be coupled to an external diagnostic device, such as in the system100depicted inFIG. 1.

Referring toFIG. 20, a user may open a user interface of an application on a PMD. In one embodiment, the application may test2302for a web connection and determine2304(query1) whether the PMD is connected to the internet or other network. If the PMD is connected, the application may prompt2306the user for demographic information. The prompt2306may be displayed to the user. In another embodiment, the prompt2306may be accomplished by an audible signal (e.g., a voice). The application may also prompt2308(query2) the user to inquire whether the user would like the demographic information added to a database. If the user responds to query2in the affirmative, the application may generate2310a form and display2312the form to the user through the user interface. The user may then enter2314data into the form and submit the data and/or the form to the application, which parses or otherwise processes2316the data and stores2318it in a database to be accessed at a later time. The application may then proceed2320to an application home screen. If the user responds to query2for information in the negative, the application may proceed2320directly to the home screen.

From the home screen, the user may either select2322to proceed to another functional area of the application, such as the “support network,” which will be discussed in greater detail below with reference toFIG. 22, or may select2324an option to proceed to prepare to perform a test. If the user selects2322to proceed to the support network, the user may prompt2323the application to initiate a support network module or tool. If the PMD is not connected to the internet, query1is answered in the negative, and the application proceeds directly to preparing to perform a test.

When the user selects the option to perform a test, the application a prompt2326may be provided and received to begin the test. The application may request2328information pertaining to one or more prerequisites to performing the test. The application may determine2330(query3) whether the user has performed the necessary prerequisite tasks to perform the test. These may include questions about the last meal the user consumed, whether or not the PMD and external diagnostic device are positioned on a flat surface. If a user response in query3is not suitable, the application may prompt2332with instructions to address these responses. Questions will continue until all prerequisites are satisfied, at which time the application may proceed with the method2300.

The application may check2334whether the PMD has sufficient battery power to provide the driving force for the external diagnostic device throughout the duration of the test. A determination2336may be made whether the PMD has sufficient power. If the PMD does not have sufficient battery power, the application may prompt2338the user to charge the PMD before proceeding to the test. A determination2340(query4) may again be made whether the PMD has sufficient power or has been sufficiently charged. The user may elect to skip the test and proceed2342to the home screen (and on to the support network, if desired). If the PMD has sufficient battery power or has been charged sufficiently, the application may proceed to load2344a particular diagnostic test pathway or test module.

A “pre-test” module of the application may prompt2346the user to select whether to have a tutorial presented explaining function and procedure of the test, for example, in text, image, video, or other format. A determination2348(query5) is made whether the user selected to receive the tutorial. If the user responds affirmatively to query5, the application may load2350the tutorial and display2352and/or otherwise present the tutorial, after which the application may prompt2354the user to couple the external diagnostic device to the PMD, for example, by inserting the external diagnostic device into a receiving PMD port. If the user responds in the negative to query5, the application may proceed directly to prompt2354. The application may launch an authentication test, in which the application may “ping”2356the external diagnostic device, for example to read2358a unique authentication signature from the external diagnostic device. The application then may trigger two (possibly parallel) pathways. In one, a verification2364of the authentication signature is performed and a determination2366(query6) may be made whether the external diagnostic device appropriately authenticates. If the external diagnostic device does not authenticate, the application may generate2368and display an error message, with options and instructions on how to proceed.

In the second pathway, a verification2362of the authentication signature is performed and the application may then generate2370and display a key code entry form and prompt2372the user to enter a verification key (found, for example, on the container in which the external diagnostic device was packaged). The verification key may be a unique code. The application may verify2374the device authentication. A determination2376(query7) may be made whether the external diagnostic device appropriately authenticates. If this code is not accepted, the application may respond by displaying2378an error message, and may reset the key code entry form indefinitely, until the user enters the code that corresponds with the external diagnostic device, or returns to the home screen of the application. If this code is entered correctly and query6is determined in the affirmative, the application may proceed.

The application may prompt2380the user to utilize an absorbent swab to collect saliva from one of a few areas in the user's mouth (e.g., “Swab the gum”), The application may prompt2382the user to insert this swab into the external diagnostic device, and seal the swab inside the external diagnostic device. The application may “ping” the external diagnostic device to verify2384appropriate placement and/or positioning of the swab in the external diagnostic device and the seal by a plurality of mechanisms. A determination2386(query8) is made whether the placement of the swab is correct or not. If query8is answered in the negative, the application may prompt2388the user to re-swab or to reposition the swab. If query8is affirmed, the application may proceed to initiate the test.

FIG. 21depicts a flow diagram of a method2400for diagnostic testing, according to another embodiment of the present disclosure. At initiation of the diagnostic testing method2400, the application may initiate2402a “power supply” function or controller, which may supply or otherwise control power to the external diagnostic device. This power supply function may initially perform a verification2404of prerequisites of the system, such as completion of the circuit through which current may be driven to power the external diagnostic device. A determination2406(query9) may be made whether the prerequisites have been met. If the prerequisites have not been met, such as if the circuit is compromised, an error message may be output2408and/or displayed2410to the user.

If query9is affirmed, the power supply may proceed to instruct2412the PMD to output levels of current to pins in the PMD port that may correspond to and activate pumps in the external diagnostic device. The PMD may output2414the instructed current. The pumps in the external diagnostic device may introduce a fluid into reaction wells containing electrodes in the external diagnostic device, which allow a diagnostic test to occur. Current generated in the aforementioned reaction wells, which may be facilitated by the power supply function, may be monitored2416at the pins of the PMD port by a “signal read” function. As fluid is introduced into reaction wells, electrochemical reactions in reaction wells may cause2418a rate of change or electrical signal that may be monitored by the signal read function. The signal read function may consider minimum and maximum threshold levels. The minimum and maximum threshold levels may be predetermined. A determination2419(query10) may be made when an electrical signal with sufficient magnitude, as measured at the pins of the PMD port corresponding to electrodes in the reaction well, may rise above the threshold level, which may indicate a saturation of the electrodes in the reaction wells. The fluid may continue to be introduced into the reaction wells until this threshold is reached, at which time the signal read function may generate an output2420that may trigger the power supply function to cease providing current, which may in turn stop fluid introduction.

The electrochemical reactions may continue in the reaction wells, and may be monitored2422by the same signal read function at the pins of the PMD port. The test may be completed by a plurality of mechanisms. In one embodiment, the electrical signal due to the concentration of a given species in the reaction well may be collected and input or stored2424into an array, which may be created2426. The collection and storage2424may occur, possibly continuously, until an allotted time passes, at which time an “array read” function may initiate2428to analyze the data in this array. The values in the array may be compared against an absolute threshold of signal to determine2430(query11) whether the signal constitutes a positive result and/or to determine2432whether the signal constitutes a negative result, or an indeterminate result. The array read function may then generate2434,2444,2452, a qualitative or quantitative test result, and may package it for delivery to the application, which may then display2436,2446,2454the result to the user.

In an alternate embodiment, the signal from the reaction wells may be continuously monitored2462, and a rate of signal change may be compared against a rate threshold as monitored by the signal read function. A given signal change rate may indicate a given concentration of some species in the reaction well, and may result in a positive determination2460, an indeterminate determination2450, or a negative determination2442. Each threshold may trigger2440,2458the power supply function to cease, and the signal read function may generate2438,2448,2456and/or package the result for delivery to the application, which may then display2436,2446,2454the result to the user.

A prompt may be presented2464(query13) to the user to decide whether to proceed2470to the support network, or to return2468to the application's home screen. The user may select the option to proceed2470to the support network, which may trigger the application to initiate the support network function.

FIG. 22depicts a flow diagram of a method2500of accessing a support network, based on diagnostic testing, according to another embodiment of the present disclosure. InFIG. 22, the support network may commence by generating and/or displaying a prompt2502(query14) asking the user if they would like to see a tutorial about the support network. If the user responds to query14in the affirmative, the support network may run2504a “welcome” function, which may generate and display2506text, images, video, or other material, which may provide the user information. The text, images, video, or other material may be displayed2506on the PMD, for example. A “database” function may be triggered2508, which may refer to demographic information, information aggregated during the test, or other information.

If the user responds to query14in the negative, the user may be presented with several options, including a presentation2510of an option to proceed directly to finding resources, in which the support network may also trigger2508the database function. The user may also decide to proceed2512directly to rating resources that the user may have previously utilized or otherwise interacted with. A listing of previously utilized resources, may be collected, for example, in a folder separate from the rest of the support network, or may be accessed by another mechanism.

Once triggered2508, the database function may generate and display a prompt2514to the user, which may ask2516(query15) whether the user would like to share data gathered throughout the test anonymously or non-anonymously that may benefit public health institutions, research organizations, peer support groups, or other groups. If the user responds in the affirmative, the database may access the various forms submitted or arrays populated by the user or the application, and may package2518these data, and generate an output to be transmitted to external entities by a plurality of mechanisms. The support network may then generate and display2520a message thanking the user.

The database function may subsequently terminate2522, which may trigger the generation2524and/or presentation of a graphical user interface (GUI). If the user responds to query15in the negative, the method2500may proceed directly to generation2524and/or presentation of this GUI, which may generate a grid, list, pulldown menu, pushbuttons, or other user input options. These options may be displayed2526and may represent a high-level variety of resource categories. A user input selection2528may be received that indicates a user selection of one of the resource categories, which I may trigger2530the generation and display (in text, image, video, or other format), for example, of another GUI or window containing specific resources within a selected resource category. A variety of input mechanisms may also be present in this GUI or window.

The support network may determine2532whether these displayed category resources are composed of location-agnostic information or resources. If these resources are location-agnostic, the category resource may generate2534a specific set of user input mechanisms by which the user may select specific resources. The user input mechanisms may be displayed2536, for example on a GUI. User input received, for example through the GUI, may select2538a resource, which may be displayed2540, and the category resource may determine2542(query17) whether the selected resource is housed within the category resource, or if a link to an outside resource may be required. If query17is negative, the category resource may retrieve and display2544the data associated with the specific resource within the support network environment. If query17is determined to be affirmative, the category resource may generate and display2546to the user a link, contact information, or other mechanism that may direct the user out of the support network. Direction outside of the support network may also trigger a “referral” function which may trace the user's contact, and store record of the referral. Data may be packaged2548and output2550to the resource and/or an appropriate application. The resource information may be presented for viewing2552and/or contacting.

If the response to query16is that resources may be location-specific, the category resource may trigger2554the support network to run a “GPS” function, which may generate and display a prompt2556to the user asking whether the support network may use the user's current location. A determination2558(query18) is made whether GPS is allowed. If query18is affirmed, one of two pathways may be taken. In one embodiment, the support network may be triggered to open2580and/or run a “Maps” application, which may locate2582the user's location through a GPS hardware, software, or system located, for example, in the PMD. This GPS may then, through the “Maps” application, output2584data about the user's location, which may be retrieved2586by the support network and may be outputted2588to the category resource, triggering a map generation and display2590. This display2590of a map may allow the user to visualize their position in relation to resources around them. The category resource may also generate2592input mechanisms and prompt2593(query19) the user to define a search area.

In an alternate embodiment, after the user has responded to query18in the affirmative, the support network may open2580and run a “Maps” application. The category resource may directly utilize the GPS system of the PMD to locate2594the user's position and retrieve496this datum. The category resource may then output2598this location information to a map generated2599within the category resource, and may also display the map to allow the user to visualize their geographic location. The category resource may also generate2592input mechanisms and prompt2593(query19) the user to define a search area.

The category resource may generate and display, with query19, user input options that allow the user to manipulate2595the input options to specify an annular area of a given inner and outer radius (i.e. between 5 and 25 miles from the user) from which to return resource results. This path may then converge with the pathway from a negative answer to query18, and the category resource may generate2560and display other options for specifying the criteria of resources returned and displayed to the user. The user may then commence a search2562, triggering the category resource to compare all resources in the category against the user's specifications. The category resource may then retrieve and/or generate2564information associated with those resources that align with the user's criteria, and may display2566them on a map, with or without a reference point showing the user's position, and therefore provide either geo-specific or location-agnostic resources. In the process of retrieving data about the resources, the category resource may also populate or otherwise output2576an array2578with the information gathered from the search. When the user selects2568a given resource, an “array read” function may be triggered2570, which may read2572data in the generated array, aggregate the data, package it, and output it to the category resource. The category resource may then display2574the data. This pathway may then converge on query17, and may follow similar pathways.

EXAMPLES

A diagnostic testing surface was prepared by immobilizing a peptide comprising methylene blue, an antibody capture probe specific to HIV-1 capsid protein, p24, a hydrocarbon chain, and a thiol group onto the surface of an electrode of a diagnostic device according to the present disclosure. A sample solution was prepared by eluting an HIV-1 capsid protein, p24 in a physiological buffer solution containing Tris, NaCl, KCl, MgCl2, and CaCl2which mimics the chemical environment of blood serum. A control solution was also prepared consisting of the physiological buffer solution in the absence of the HIV-1 capsid protein, p24.

An aliquot of the sample solution was dispensed onto the diagnostic testing surface and the current density was measured using cyclic voltammetry, a procedure wherein the current density is measured as the voltage input is varied over time. An aliquot of the control solution was separately dispensed onto a diagnostic testing surface and the current density was also measured using cyclic voltammetry. The measured current densities of the sample solution and the control solution are illustrated in the graph ofFIGS. 23 and 24, whereFIG. 24is an enlarged portion of the graph ofFIG. 23.

InFIGS. 23 and 24, line A represents the current density of the control sample, and lines B, C, and D represent the current density of the sample solution taken after 5, 10, and 20 minutes, respectively. Lines A, B, C, and D represent measurements of the current densities that were taken during a cycle where the voltage was being lowered. Lines A′, B′, C′, and D′ represent measurements of the current densities that were taken during a cycle where the voltage was being raised.

The difference between the current densities (i.e., the height of the peaks) of the control solution and the sample solution represents the change in current caused by a conformational change on the diagnostic testing surface. The current densities (i.e., electrical signals) may be transmitted from the diagnostic device and to a PMD for processing into a qualitative diagnostic result, a quantitative diagnostic test result, or both.

A second aliquot of the sample solution was dispensed onto the diagnostic testing surface and the current density was measured using cyclic voltammetry. A second aliquot of the control solution was also separately dispensed onto a diagnostic testing surface and the current density was also measured using cyclic voltammetry. The measured current densities of the sample solution and the control solution are illustrated in the graph ofFIG. 25.

A diagnostic testing surface was prepared by immobilizing a peptide comprising an antibody capture probe specific to PBP2a protein onto the surface of an electrode of a diagnostic device according to the present disclosure. A sample solution was prepared by eluting a PBP2a protein in a physiological buffer solution containing Tris, NaCl, KCl, MgCl2, and CaCl2which mimics the chemical environment of blood serum. A control solution was also prepared consisting of the physiological buffer solution in the absence of the PBP2a protein.

An aliquot of the sample solution was dispensed onto the diagnostic testing surface and the current density was measured using cyclic voltammetry, a procedure wherein the current density is measured as the voltage input is varied over time. An aliquot of the control solution was separately dispensed onto a diagnostic testing surface and the current density was also measured using cyclic voltammetry. The measured current densities of the sample solution and the control solution are illustrated in the graph ofFIGS. 26 and 27, whereFIG. 27is an enlarged portion of the graph ofFIG. 26.

InFIGS. 26 and 27, line A represents the current density of the control sample, and lines B and C represent the current density of the sample solution taken after 5 and 10 minutes, respectively. The difference between the current densities (i.e., the height of the peaks) of the control solution and the sample solution represents the change in current caused by a conformational change on the diagnostic testing surface. The current densities (i.e., electrical signals) may be transmitted from the diagnostic device and to a PMD for processing into a qualitative diagnostic result, a quantitative diagnostic test result, or both.

The present disclosure has been made with reference to various exemplary embodiments including the best mode. However, those skilled in the art will recognize that changes and modifications may be made to the exemplary embodiments without departing from the scope of the present disclosure. For example, various operational steps, as well as components for carrying out operational steps, may be implemented in alternate ways depending upon the particular application or in consideration of any number of cost functions associated with the operation of the system, e.g., one or more of the steps may be deleted, modified, or combined with other steps.

Additionally, as will be appreciated by one of ordinary skill in the art, principles of the present disclosure may be reflected in a computer program product on a tangible computer-readable storage medium having computer-readable program code means embodied in the storage medium. Any suitable computer-readable storage medium may be utilized, including magnetic storage devices (hard disks, floppy disks, and the like), optical storage devices (CD-ROMs, DVDs, Blu-Ray discs, and the like), flash memory, and/or the like. These computer program instructions may be loaded onto a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions that execute on the computer or other programmable data processing apparatus create means for implementing the functions specified. These computer program instructions may also be stored in a computer-readable memory that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory produce an article of manufacture including instruction means which implement the function specified. The computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer or other programmable apparatus to produce a computer-implemented process such that the instructions which execute on the computer or other programmable apparatus provide steps for implementing the functions specified.

The foregoing specification has been described with reference to various embodiments. However, one of ordinary skill in the art appreciates that various modifications and changes can be made without departing from the scope of the present disclosure. Accordingly, this disclosure is to be regarded in an illustrative rather than a restrictive sense, and all such modifications are intended to be included within the scope thereof. Likewise, benefits, other advantages, and solutions to problems have been described above with regard to various embodiments. However, benefits, advantages, solutions to problems, and any element(s) that may cause any benefit, advantage, or solution to occur or become more pronounced are not to be construed as a critical, required, or essential feature or element. As used herein, the terms “comprises,” “comprising,” or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Also, as used herein, the terms “coupled,” “coupling,” or any other variation thereof, are intended to cover a physical connection, an electrical connection, a magnetic connection, an optical connection, a communicative connection, a functional connection, and/or any other connection.

It will be obvious to those having skill in the art that many changes may be made to the details of the above-described embodiments without departing from the underlying principles of the disclosure.