Patent Application
20190257814
A smart rapid result diagnostic system distributed on one or more servers and operably coupled to one or more client computing devices or one or more clinician computing devices by a public network which supports a smart rapid result diagnostic application accessible on-line or downloadable by the client computing devices to establish off-line connection with one or more assay devices operable to detect an analyte in a sample and provide locked or unlocked access to the assay results based on one or more references correlated with one or more assay tables in an assay table library.
A broad object of a particular embodiments of the invention can be to provide a computer implemented application program distributed on one or more servers and operably coupled to one or more client computing devices or one or more clinician computing devices by a public network accessible on-line or downloadable by the client computing devices to establish off-line connection with one or more assay devices operable to detect an analyte in a sample and provide locked or unlocked access by the client computing device to the assay results of the assay device.
A broad object of particular embodiments of the invention can be to provide an assay device which receives an assay material and generates an assay result indicative of a presence or an amount of an analyte bound to the assay material and which communicatively connects to a client computing device to transmit assay results accessible by the client device based upon correlation of the assay identification codes with one or more client identification references, coordinate location references, governmental or agency regulatory references, or clinician permission references.
A broad object of particular embodiments of the invention can be to provide client computing device having a client processor communicatively coupled with a non-transitory computer readable media containing a smart rapid result diagnostic application program executable to communicatively connect the client computing device to an assay device which generates an assay result indicative of a presence or an amount of an analyte bound to the assay material and receives assay results from the assay device and based upon correlation of one or more client identification references, governmental or agency regulatory references, coordinate location references, or clinician permission references provides unlocked access by the client device to the assay results.
Naturally, further objects of the invention are disclosed throughout other areas of the specification, drawings, photographs, and claims.
The System. Generally, referring to
desktop computer devices, and mobile computer devices such as personal computers, slate computers, tablet or pad computers, cellular telephones, personal digital assistants, smartphones, programmable consumer electronics, or combinations thereof. The network (5) supports a smart rapid result diagnostic application (11) (also referred to as the “application program”) accessible by browser based on-line processing or downloadable by the client computing devices (3) to enable client computing devices (4) to establish off-line wired or wireless connection with one or more assay devices (12) operable to detect an analyte (13) in a sample (14) and to provide an assay data processing module (15) operable by the client computing device (3) or the clinician computing device (4) to receive an assay result (16) from the assay device (12) and to further determine if the assay result (16) can be accessed by the client computing device (3) (also referred to as “unlocked access (17)”) or cannot be accessed by the client computing device (3) (also referred to “locked access (18)”) based on one or more references (19). In the illustrative example described and shown in
The Assay Device. Now referring primarily to
United States or comparable standards in foreign countries. In particular embodiments, the assay device (12) can be structured to practice only over-the-counter procedures or assays (for example, FDA Class I in vitro diagnostic device (or other medical devices). However, in particular embodiments, the invention may further encompass assay devices (12) structured to practice procedures or assays which may otherwise be delimited to research laboratories, analytical testing laboratories, by prescription, or otherwise fall outside of self-screening or point of care procedures (for example FDA Class II, III or IV in vitro diagnostic device (or other medical devices).
Typically, assay devices (12) include an assay material (22) (also referred to as a “test strip”) having an analyte capture region (23) capable of retaining or selectively binding an analyte (13) in a sample (12) and an assay material reader (24) into which the assay material (22) can be disposed or received to sense a presence or an amount of analyte (13) in the sample (14).
For the purposes of this invention, the term “sample (14)” means a liquid or solid material that can be applied to the assay material (22). A solid sample such as feces can, but need not necessarily, be dissolved in a suitable solvent before being applied to the assay material. Similarly, a liquid sample can, but need not necessarily, be treated with another liquid (such as water or an aqueous solution) to reduce its viscosity or increase its volume before being applied to the assay material (22). The sample (14) can be derived from any source. In particular embodiments, the source can, but need not necessarily, be a bodily fluid, such as one or more of: blood, serum, plasma, saliva, sputum, ocular lens liquid, sweat, urine, milk, ascites liquid, mucous, synovial liquid, peritoneal liquid, transdermal exudates, pharyngeal exudates, bronchoalveolar lavage, tracheal aspirations, cerebrospinal liquid, semen, cervical mucus, vaginal or urethral secretions, and amniotic liquid.
For the purposes of this invention, the term “analyte (13)” means any substance whose chemical constituents are being identified or measured. As illustrative examples an analyte (13) can include one or more of: therapeutic drugs, drugs of abuse, hormones, vitamins, proteins, antibodies, peptides, steroids, bacteria, fungi, viruses, parasites, antigens, allergens, T4, T3, digoxin, hCG, insulin, theophylline, luteinizing hormone, organisms causing or associated with various disease states, such as streptococcus pyogenes (group A), Herpes Simplex I and II, cytomegalovirus, chlamydiae, human bone alkaline phosphatase antigen (HBAPAg), human chorionic gonadotropin (hCG); human luteinizing hormone (hLH), human follicle stimulating hormone (hFSH), creatine phosphokinase MB isoenzyme; ferritin, carcinoembryonic antigen, prostate specific antigen; CA-549 breast cancer antigen, hepatitis B surface antigen, hepatitis B surface antibody, hepatitis B core antigen, hepatitis B core antibody, hepatitis A virus antibody, an antigen of human immunodeficiency virus HIV I, such as gp120, p66, p41, p31, p24 or p17, the p41 antigen of HIV II, and the respective anti-ligand (whether polyclonal or monoclonal antibody) to any one of the above ligands.
For the purposes of this invention the term “analyte capture region (23)” means the portion or region of the assay material (22) capable of selectively binding an analyte (13) in a sample (14). In particular embodiments, the sample (14) can, but need not necessarily be, contacted directly with the analyte capture region (23) where a reaction or binding event occurs to afford an assay result (16). In particular embodiments, the sample (14) can be applied to the assay material (22) and subsequently conveyed along the assay material (22), for example by capillary action, to the analyte capture region (23) where a reaction or binding event occurs to afford an assay result (16). As an illustrative example, the analyte (13) in the sample (14) can be conveyed to interact with a labelled specific binding reagent (also referred to as a “label”) to form a labelled complex (30). The label can comprise as illustrative examples: a metallic sol (such as gold), non-metallic elemental sol (such as selenium or carbon), dye sols, colored latex or polystyrene particles, or combinations thereof. The labelled complex (3) can comprise a colored particle. The labelled complex can be conveyed to and selectively bound to the analyte capture region (23), and thereby concentrated to indicate a presence or an amount of analyte (13) in the sample (14).
The assay device (12) can further include an assay material reader (24). The assay material (22) can be associated with, disposed on or inserted within the assay material reader (24). The assay material reader (24) can then operate a sensor (25) which generates an analyte measurement signal (26) indicative of a presence or an amount of the analyte (13) bound or selectively bound to said analyte capture region (23) of the assay material (22). In particular embodiments, the assay material (22) can be disposed or inserted to align the analyte capture region (23) in an assay material detection zone (27) of the assay material reader (24) and an analyte measurement sensor (25) can operate to generate an analyte measurement signal (26) indicative of a presence or an amount of the analyte (13) associated, bound or selectively bound to the analyte capture region (23) of the assay material (22). In particular embodiments, the assay material reader (24) can include a source of electromagnetic radiation (28) and one or more sensors (25) capable of detecting intensity of electromagnetic radiation (29). The source of electromagnetic radiation (28) and the sensors (25) can be positioned within the assay material reader (24) such that when the material assay reader (24) admits or receives the assay material (22) or test strip, the electromagnetic radiation (29) impacts the analyte (13) or labelled complex (30) upon the assay material (22).
In principle, any electromagnetic radiation (29) can be used to affect a fluorescence, a light absorption, or a light transmission measurement. In particular embodiments, the wavelength of the electromagnetic radiation (29) can be chosen at or near a wavelength which influences (results in luminescence of the analyte (13) or labeled complex (30)) or is influenced by (absorbed, by the analyte (13) or analyte complex (30)). In particular embodiments, the fluorescence emission of the analyte (13) or labelled complex (30) can be sensed by the sensor (25), such as a photosensor. In particular embodiments, the electromagnetic radiation (29) impacts the analyte (13) or labelled complex (30) upon the assay material (22) and the amount of reflected electromagnetic radiation (29) can be sensed by the sensor (25). In particular embodiments, the sensor (25) can be an analyte image capture element (25′) which generates an analyte measurement signal (26) in the form of analyte image pixel signals (26′) which vary based on luminance and color differences relating to the presence or amount of analyte (13) or analyte complex (30).
The assay reader (24) can further include a reader assay data processor (31) operable to receive the analyte measurement signal (26, 26′) indicative of the presence or the amount of the analyte (13) bound or selectively bound to said analyte capture region (23). The analyte measurement signal (26, 26′) can corresponding vary based on the presence or amount of the analyte (13) or analyte complex (30) bound to the analyte capture region (23). In particular embodiments, the reader assay data processor (31) can include an analog to digital convertor (21) to covert analog analyte measurement signals (26, 26′) into a digital signal (26″) The reader assay data processor (31) compare intensity of the analyte measurement signal (26, 26′, 26″) to one or more control thresholds (32). The reader assay data processor (31) can generate an assay result (16) based on comparison of the analyte measurement signal (26, 26′, 26″) to the one or more control thresholds (32). Typically, intensity of the analyte measurement signal (26) less than a control threshold (32) generates a negative result (33) while intensity of the analyte measurement signal (26) greater that the control threshold (32) generates a positive result (34) indicating the presence of the analyte (13, 30) or intensity of the analyte measurement signal (26) greater than a first control threshold (32′) but less than a second control threshold (32″) generates result (34) indicating the relative amount of the analyte (13, 30).
The assay reader (24) can further include a reader electronic data exchanger (35) operable to transmit assay material reader pairing information (36) to the client computing device (3). In particular embodiments, the assay device (12) can correspondingly include a radio frequency controller (37) which operates a radio frequency transmitter (38) to cause wireless connection or pairing of the assay device (12) with a client computing device (3) over a short-range radio frequency band (39) to carry a signal over all or a part of the communication path between the assay device (12) and a client computing device (3). The short-range frequency band (39) can include, as illustrative examples: BLUETOOTH® (40) which operates at frequencies of about 2402 MHz to about 2480 MHz or about 2400 MHz to about 243.5 MHz or WI-FI® (41) which operates at about 2.4 GHz or 5 GHz. In other particular embodiments, the assay device (12) can, but need not necessarily include, a tone generator (42) which generates tones (43) also referred to as an “audio beacon” that provides a signal over the communication path between the assay device (12) and a client computing device (3).
In particular embodiments, the reader electronic data exchanger (35) can further operate to transmit assay identification code (44)(shown in
In particular embodiments, the reader electronic data exchanger (35) can further operate to transmit an assay result (16) based on the comparison of the analyte measurement signal (26) to one or more control threshold(s) (32). The assay device (12) can send the assay result (16) in a string of data, such as, 1.2.3.4.5.6.7.8.9.10.11.12 where the data corresponds to the assay result (16) for one or more analytes (13) or labeled complexes (30) assayed. The data string can correspond to quantitative amounts of one or more analytes (13) or can correspond to binary determination of presence of one or more analytes (13). For example, 1 can correspond to a positive assay result (34) and 0 can correspond to a negative assay result (33).
The Client Computing Device. Now referring primarily to
The Clinician Computing Device. Again, referring primarily to
The Electronic Medical Record. The term “electronic medical records (52)” refers the legal record of client (108) encounters and medical services received from one or more care delivery organizations (53). The electronic medical records (52) of a client (108) may be contained in one or a plurality of medical record databases (54). As an illustrative example, a care delivery organization (53) might include a hospital and a clinic owned by the same parent company and using a common format for electronic medical records (52) which are stored in the common medical record database (54). However, the care delivery organization (53) can be a plurality of unaffiliated health providers correspondingly using one or more unaffiliated medical record databases (54).
The Smart Rapid Result Diagnostic Application. Again, referring primarily to
In particular embodiments, the application program (11) can be executed to communicate with the server (2) over the network (5) to coordinate operation of the client computing device (3) with operation of the assay device (12) or a clinician computing device (4). However, this is not intended to preclude embodiments in which the application program (11) may be contained on and loaded to the client computing device (3), the clinician computing device (4) or the assay device (12) from one or more of: a computer disk, universal serial bus flash drive, or other computer readable media. While embodiments of the application program (11) are described in the general context of computer-executable instructions such as program modules which utilize routines, programs, objects, components, data structures, or the like, to perform particular functions or tasks or implement particular abstract data types, it is not intended that any embodiments be limited to a particular set of computer-executable instructions or protocols. Additionally, in particular embodiments, while particular functionalities of the application program (11) may be attributable to one of the assay device (12), the client computing device (3) or the clinician computing device (4); it is to be understood that embodiments may allow implementation of a function by more than one device, or the function may be coordinated between more than one device.
Now referring primarily to
Again, referring primarily to
The Graphical User Interface. Now referring primarily to
The Signup Module. Now referring primarily to
The Login Module. Again, referring primarily to
The Setup Module. Now referring primarily to
Now referring primarily to
age status (70), gender status (71), weight status (72), and height status (73) of the client user (50) that will interact with the assay device (12)(as shown in the example of
Now referring primarily to
Now referring primarily to
The Communication Module. Now referring primarily to
In particular embodiments, the assay device communication module (90) can, but need not necessarily, operatively communicate with the server (2) over the network (5) to communicatively couple the client computing device (3) with the assay device (12) and coordinate or pair operation of the client computing device (3) or the clinician device (4) with operation of assay device (21) as part of an internet of things (“TOT”) or TOT device (109). For the purposes of this invention the term “TOT device” means physical devices embedded with electronics, software, sensors, actuators and public, cellular, or other network connectivity to collect and exchange data and without reduction in the breadth of the foregoing definition includes as illustrative examples: glucose meters, blood pressure meters, intravenous pumps, activity or fitness monitors, or tooth brushes. In particular embodiments, the client computing device (3) and the assay device (22) can, but need not necessarily, be TOT devices part of the TOT.
The Global Positioning Module. Again, referring primarily to
In particular embodiments, a global positioning module (101) of the application program (1) can be executed upon pairing (91) of the client computing device (3) with the assay device (12) to retrieve the location coordinates (97) of the client computing device (3) from the geographic location calculator (92). The location coordinates (97) can be further applied by the assay data processing module (15) as a global positioning reference (20b) in processing assay results (16) transmitted from the assay device (12) to the client computing device (3) to determine if the client computing device (3) has unlocked access (17) or locked access (18) to the assay results (16).
The Assay Data Processing Module. Again, referring primarily to
In particular embodiments, the assay data processing module (15) having associated the assay device identification code (44) with an assay table (103) in the assay table library (102) can, but need not necessarily, be further executed to depict instructions on the display surface (59) of the client computing device (3) regarding use of the assay material (22) with the assay material reader (24) (shown in the example of
In particular embodiments, disposal or insertion of the assay material (22) into the assay reader (24)(shown in the example of
In particular embodiments, the assay data processing module (15) can lock access (18) to the assay results (16) (shown in
In particular embodiments, if the assay results (16) associated with the assay identification code (44) received by the client computing device (3) cannot be correlated by the assay data processing module (15) by reference (19) to an assay table (103) contained in the assay table library (102), then the assay data processing module (15) can function to maintain the assay results (16) in the client computing device memory (49) with locked access (18) by the client computing device (3). Subsequently, the client computing device (3) can connect via the network (5) with the server (2) to download an updated assay table library (103) (process A). If the updated assay table library (102) can be correlated by reference (19) with the assay identification code (44), then the client assay data processing module (15) can, but need not necessarily, provide unlocked access (17) by the client computing device (3) to the assay table (103) and the corresponding assay results (16) and other assay datum (105).
In particular embodiments, upon pairing (process G) of the client device (3) with the assay device (12) the assay data processing module (15) can be executed to retrieve the geographic location (93) defined by location coordinates (97) determined by the geographic location calculator (92)(shown in
In particular embodiments, the data processing module (15) can be further executed to correlate a government or regulatory reference (20c) with each assay table (102) in the assay table library (103). The government or regulatory reference (20c) can reflect federal, state or local laws, regulations or rules (or similar laws, regulations, or rules of any foreign region, country or locality) which delimit the use of an assay device (12) or the release of the assay results (16) to the client computing device (3). As one illustrative example, the United States Food and Drug
Administration (“FDA”) maintains a medical device database of over-the-counter (“OTC”) medical devices and tests and (non-prescription devices and assays) that have been cleared or approved by the FDA, and also, maintains a medical device database of tests and medical devices that require a prescription from a clinician (107). If for example, the assay (45) has been cleared or approved by the FDA as an OTC assay device (12) for performing and OTC assay (45), the assay table (103) associated with the assay identification code (44) can be matched with the regulatory reference (20c) which allows the client computing device (3) access to the assay results (16) transmitted from the assay device (12). In particular embodiments, use of the assay device (12) an assay (45) may be delimited to a particular geographic locations (93). In the illustrative example, if upon pairing of the client computing device (3) with the assay device (12), the client device (3) has location coordinates (97) corresponding to a geographic location (93) in the United
States, then the global positioning reference (20b) can be further correlated with the assay identification code (44) and government or regulatory reference (20c) and the combination of references (19) allows the assay results (16) of the assay (45) to be accessed by the client computing device (3). Conversely, if the retrieved location coordinates (97) associated with the geographic location (93) of the client computing device (3) paired (process A) with the assay device (12) cannot be referenced with an assay identification code (44) in an assay table (103) in the assay table library (102) because the assay identification code (44) requires a clinician permission reference (20d), or a clinician access reference (20c), the computing device assay data processing module (15) maintains locked access (18) by the client computing device (3) to the assay results (16) or other assay datum (105).
In particular embodiments, the assay data processing module (15) can maintain locked access (17) to assay results (16) by the client device (3) unless the assay identification code (44) can be correlated with a clinician permission reference (20d). The assay data processing module (15) can be executed to receive clinician permission references (20d) which can be correspondingly associated with the assay identification code (44)(shown in
The assay data processing module (15) can be further executed to depict the assay result (16) on the display surface (59) of the client computing device (3)(shown in
The Clinician Assay Data Processor. In particular embodiments, either the assay device (12) or the client computing device (3) can via the network (5) transmit assay test results (16) to the electronic medical record (52) associated with a client identification code (106) and which can include a date-time stamp (84)(85). A clinician (51) can access the electronic medical record (52) associated with the client identification code (106) and receive assay results (16) referenced to the client identification code (106). The clinician (51) can determine if the client computing device (3) should have unlocked access (17) to the assay results (16). If, yes, then the clinician (107) can by user command (58) in the clinician device (4) transmit a clinician permission reference (20d) to the client computing device (3). The clinician permission reference (20d) correlated with the client device identification reference (20a) and the assay identification code (44) contained in an assay table (103) within the assay table library (102) can enable unlocked access (17) by the client computing device (3) to the assay results (16) or other assay datum (105). The clinician permission reference (20d) can be transmitted via the network (5) and received by the client computing device (3).
As can be easily understood from the foregoing, the basic concepts of the present invention may be embodied in a variety of ways. The invention involves numerous and varied embodiments of a smart rapid result diagnostic system and methods for making and using such smart rapid result diagnostic system including the best mode.
As such, the particular embodiments or elements of the invention disclosed by the description or shown in the figures or tables accompanying this application are not intended to be limiting, but rather exemplary of the numerous and varied embodiments generically encompassed by the invention or equivalents encompassed with respect to any particular element thereof. In addition, the specific description of a single embodiment or element of the invention may not explicitly describe all embodiments or elements possible; many alternatives are implicitly disclosed by the description and figures.
It should be understood that each element of an apparatus or each step of a method may be described by an apparatus term or method term. Such terms can be substituted where desired to make explicit the implicitly broad coverage to which this invention is entitled. As but one example, it should be understood that all steps of a method may be disclosed as an action, a means for taking that action, or as an element which causes that action. Similarly, each element of an apparatus may be disclosed as the physical element or the action which that physical element facilitates. As but one example, the disclosure of an “assay” should be understood to encompass disclosure of the act of “assaying”—whether explicitly discussed or not—and, conversely, were there effectively disclosure of the act of “assaying”, such a disclosure should be understood to encompass disclosure of an “assay” and even a “means for assaying.” Such alternative terms for each element or step are to be understood to be explicitly included in the description.
In addition, as to each term used it should be understood that unless its utilization in this application is inconsistent with such interpretation, common dictionary definitions should be understood to be included in the description for each term as contained in the Random House Webster's Unabridged Dictionary, second edition, each definition hereby incorporated by reference.
All numeric values herein are assumed to be modified by the term “about”, whether or not explicitly indicated. For the purposes of the present invention, ranges may be expressed as from “about” one particular value to “about” another particular value. When such a range is expressed, another embodiment includes from the one particular value to the other particular value. The recitation of numerical ranges by endpoints includes all the numeric values subsumed within that range. A numerical range of one to five includes for example the numeric values 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, and so forth. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint. When a value is expressed as an approximation by use of the antecedent “about,” it will be understood that the particular value forms another embodiment. The term “about” generally refers to a range of numeric values that one of skill in the art would consider equivalent to the recited numeric value or having the same function or result. Similarly, the antecedent “substantially” means largely, but not wholly, the same form, manner or degree and the particular element will have a range of configurations as a person of ordinary skill in the art would consider as having the same function or result. When a particular element is expressed as an approximation by use of the antecedent “substantially,” it will be understood that the particular element forms another embodiment.
Moreover, for the purposes of the present invention, the term “a” or “an” entity refers to one or more of that entity unless otherwise limited. As such, the terms “a” or “an”, “one or more” and “at least one” can be used interchangeably herein.
Thus, the applicant(s) should be understood to claim at least: i) the assay system or components thereof herein disclosed and described, ii) the related methods disclosed and described, iii) similar, equivalent, and even implicit variations of each of these devices and methods, iv) those alternative embodiments which accomplish each of the functions shown, disclosed, or described, v) those alternative designs and methods which accomplish each of the functions shown as are implicit to accomplish that which is disclosed and described, vi) each feature, component, and step shown as separate and independent inventions, vii) the applications enhanced by the various systems or components disclosed, viii) the resulting products produced by such systems or components, ix) methods and apparatuses substantially as described hereinbefore and with reference to any of the accompanying examples, x) the various combinations and permutations of each of the previous elements disclosed.
The background section of this patent application provides a statement of the field of endeavor to which the invention pertains. This section may also incorporate or contain paraphrasing of certain United States patents, patent applications, publications, or subject matter of the claimed invention useful in relating information, problems, or concerns about the state of technology to which the invention is drawn toward. It is not intended that any United States patent, patent application, publication, statement or other information cited or incorporated herein be interpreted, construed or deemed to be admitted as prior art with respect to the invention.
The claims set forth in this specification, if any, are hereby incorporated by reference as part of this description of the invention, and the applicant expressly reserves the right to use all of or a portion of such incorporated content of such claims as additional description to support any of or all of the claims or any element or component thereof, and the applicant further expressly reserves the right to move any portion of or all of the incorporated content of such claims or any element or component thereof from the description into the claims or vice-versa as necessary to define the matter for which protection is sought by this application or by any subsequent application or continuation, division, or continuation-in-part application thereof, or to obtain any benefit of, reduction in fees pursuant to, or to comply with the patent laws, rules, or regulations of any country or treaty, and such content incorporated by reference shall survive during the entire pendency of this application including any subsequent continuation, division, or continuation-in-part application thereof or any reissue or extension thereon.
Additionally, the claims set forth in this specification, if any, are further intended to describe the metes and bounds of a limited number of the preferred embodiments of the invention and are not to be construed as the broadest embodiment of the invention or a complete listing of embodiments of the invention that may be claimed. The applicant does not waive any right to develop further claims based upon the description set forth above as a part of any continuation, division, or continuation-in-part, or similar application.
