Machine-readable diagnostic test device and method and apparatus for manufacturing and / or processing same

Abstract

Methods, apparatus, systems, and articles of manufacture and / or processing of diagnostic test devices are disclosed. An example apparatus includes a porous medium including a first zone including a solidified antigen corresponding to a target analyte or a solidified antibody corresponding to the target analyte and a second zone including a solidified antibody corresponding to the target analyte; a wireless chip for: wirelessly obtaining a first voltage through a signal from an external device; outputting a second voltage smaller than the first voltage to a first electrode in contact with at least one of the first region or the second region; and measuring an electrical signal from the first electrode, the electrical signal corresponding to the presence of the target analyte.

Description

[0001] Related Applications This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 284,513, filed November 30, 2021, which is related to PCT Patent Application Serial No. PCT / EP2021 / 064581, filed May 31, 2021; and U.S. Provisional Patent Application Serial No. 63 / 129,375, filed December 22, 2020. U.S. Provisional Patent Application Serial No. 63 / 284,513, PCT Patent Application Serial No. PCT / EP2021 / 064581, U.S. Provisional Patent Application Serial No. 63 / 129,375, and U.S. Provisional Patent Application Serial No. 63 / 032,093 are hereby incorporated by reference in their entireties. Priority to U.S. Provisional Patent Application Serial No. 63 / 284,513 is hereby claimed. Technical Field

[0002] The present disclosure relates generally to biosensors and, more particularly, to machine-readable diagnostic test devices and methods and apparatus for making and / or processing the same. Background Art

[0003] A biosensor (e.g., a lateral flow device, such as a lateral flow assay (LFA)) is a device capable of detecting a condition, disease, etc. in a human or animal based on a sample from the human or animal (e.g., a blood sample, a saliva sample, a urine sample, etc.). LFA has been used to detect the presence of a target analyte to determine pregnancy, the presence of HIV, the presence of Ebola, the presence of different toxins, etc. BRIEF DESCRIPTION OF THE DRAWINGS

[0004] Figure 1A is an example environment described in conjunction with the examples disclosed herein, including an exemplary machine-readable lateral flow immunoassay generator for generating a machine-readable lateral flow immunoassay.

[0005] Figure 1B yes Figure 1A Side view of an exemplary machine-readable lateral flow immunoassay.

[0006] Figure 2A Shows Figure 1A Example implementation of a portion of a machine-readable lateral flow immunoassay.

[0007] Figure 2B Shows Figure 1A

[0013] Alternative example implementation of a portion of a machine-readable lateral flow immunoassay.

[0008] Figure 2C Shows Figure 1A , 1BExample designs of any of the potentiometers and / or bioelectrochemical cells of 2A and / or 2B.

[0009] Figure 2D Shows Figure 1A Top view of an alternative example embodiment of a machine-readable lateral flow immunoassay.

[0010] Figure 2E Shows Figure 2D Side view of a machine-readable lateral flow immunoassay.

[0011] Figure 2F Shows that it can be attached to Figure 2D-2E Exemplary conjugates of immobilized antigens and / or antibodies on a test line of a machine-readable lateral flow immunoassay.

[0012] Figure 2G Shown in the example shell Figure 2D-2E Exploded diagram of an example lateral flow immunoassay.

[0013] Figure 2H An alternative exemplary machine-readable lateral flow immunoassay comprising quantum dots is shown.

[0014] Figures 2I-2K Different embodiments of front-end channels that can be used in the machine-readable lateral flow immunoassay of Figures 1-2H are shown.

[0015] Figure 2L A bottom view of a housing for the machine-readable lateral flow immunoassay of FIGS. 1-2H is shown, including an example housing cover and an example switch in a first position.

[0016] Figure 2M Shows Figure 2L Bottom view of the housing of a machine-readable lateral flow immunoassay with an example switch in a second position.

[0017] Figure 2N Shows Figure 2L A cross-sectional view of a housing of a machine-readable lateral flow immunoassay with a switch in a first position and an example electrode plate in a first position.

[0018] Fig.2O Shows Figure 2L a cross-sectional view of the housing of a machine-readable lateral flow immunoassay with the switch in a second position, and Figure 2N The example electrode plate is in the second position.

[0019] Figure 2P A perspective view of the housing of the machine-readable lateral flow immunoassay of FIGS. 1-2H is shown with an alternative example switch.

[0020] Figure 2Q is along Figure 2P A partial cross-sectional view taken along line QQ of FIG. 1 shows an example switch in a first position. Figure 2P Internal view of the housing of a machine-readable lateral flow immunoassay.

[0021] Figure 2R is along Figure 2P A partial cross-sectional view taken along line RR of FIG. 1 shows an example switch in a second position. Figure 2P Internal view of the housing of a machine-readable lateral flow immunoassay.

[0022] Figure 3A It shows that Figure 1A An alternative exemplary machine-readable lateral flow immunoassay generated by an exemplary machine-readable lateral flow immunoassay generator.

[0023] Figure 3B Shows that it may happen in Figure 3A Example circuit completion and silver amplification process in an example machine-readable lateral flow immunoassay.

[0024] Figure 4 yes Figure 1A Block diagram of an embodiment of a machine-readable lateral flow immunoassay generator.

[0025] Figure 5 is Figure 1A , 1B , 2A, 2B, 2I-2K and / or 3A, a block diagram of an implementation of a wireless chip on a machine-readable lateral immunoassay.

[0026] Figure 6 yes Figure 1A Block diagram of an embodiment of a machine-readable lateral flow immunoassay reader application.

[0027] Figure 7 A flowchart representing machine readable instructions that may be executed to implement Figure 1A and / or Figure 4 A machine-readable lateral flow immunoassay generator.

[0028] Figure 8A-10 A flowchart representing machine readable instructions that may be executed to implement Figure 1A , 2A , 2B, 2I-2K, 3A and / or 5 wireless chips.

[0029] Fig.11A-B shows a flowchart representing machine readable instructions that can be executed to implement Figure 1A and / or Figure 6 Application of machine-readable lateral flow immunoassay readers.

[0030] Fig.12 is a block diagram of an exemplary processing platform configured to perform Figure 7 Instructions to achieve Figure 1A , 1B and / or Figure 4 A lateral flow immunoassay builder.

[0031] Fig.13 is a block diagram of an exemplary processing platform configured to perform Figure 8A-10 Instructions to achieve Figure 1A , 2A , 2B, 2I-2K, 3A and / or 5 wireless chips.

[0032] Fig.14 is a block diagram of an exemplary processing platform configured to perform Figures 11A-11B Instructions to achieve Figure 1A and / or Figure 6 Application of machine-readable lateral flow immunoassay readers.

[0033] Fig.15 is to convert software (for example, corresponding to Figures 11A-11B Block diagram of an example software distribution platform for distributing software (e.g., software containing example computer-readable instructions) to client devices such as consumers (e.g., for licensing, sale, and / or use), retailers (e.g., for sale, resale, licensing, and / or sub-licensing), and / or original equipment manufacturers (OEMs) (e.g., for inclusion in products to be distributed to, for example, retailers and / or direct purchasing customers).

[0034] The figures are not drawn to scale. On the contrary, the thickness of a layer or region may be magnified in the drawings. In general, the same reference numerals will be used throughout the (multiple) drawings and the accompanying written description to refer to the same or similar parts. As used in this patent, stating that any part (e.g., layer, film, area, region or plate) is located in any way (e.g., positioned on, located on, set on or formed on, etc.) on another part indicates that the referenced part is in contact with the other part, or the referenced part is on the other part, and one or more intermediate parts are located between them. Unless otherwise specified, connection references (e.g., attachment, coupling, connection and engagement) should be interpreted broadly and may include intermediate members between element sets and relative movement between elements. Similarly, connection references do not necessarily mean that two elements are directly connected to each other and have a fixed relationship. Stating that any part is "in contact" with another part means that there is no intermediate part between the two parts. Although these figures show layers and regions with clear lines and boundaries, some or all of these lines and / or boundaries may be idealized. In reality, the boundaries and / or lines may be unobservable, blended, and / or irregular. DETAILED DESCRIPTION

[0035] The rapid diagnostic test includes a biosensor or test strip device (e.g., a lateral flow immunoassay (LFA)), which is a first section that includes obtaining a sample (e.g., blood, urine, saliva, etc.) and a second section that changes (e.g., changes color and / or undergoes another change in physical properties) when a target analyte corresponding to a specific disease or condition is present in the sample. For example, a user applies the sample to a sample pad of a test strip device or simply a "test strip" (e.g., LFA, etc.). Once applied, the sample migrates along the test strip to a conjugate pad containing a binder (e.g., a detectable marker, label, linker, antibody, antigen, etc.) specific to the target analyte. If the sample includes the target analyte, a reaction (e.g., a chemical reaction, a biochemical reaction, a physical reaction, etc.) will occur on the conjugate pad to bind the target analyte to the binder. The test strip also includes a test line containing molecules (e.g., solidified antibodies, antigens, analytes, aptamers, etc., which are specific to the target analyte) that bind to a first set of binder molecules (e.g., detector molecules) from the conjugate pad. For example, if the analyte of interest is an antibody, the positive test area includes a solidified antigen. If the analyte of interest is an antigen, the positive test area includes a solidified antibody. The marker substance or conjugate includes a first binding component capable of binding the analyte of interest, and in some examples includes a second visualization component. Therefore, when the sample (e.g., including a bound target analyte) flows to the test area (e.g., a reaction area), the antibody, analyte or antigen of the test line binds to the bound target analyte, thereby solidifying the target analyte. In some test strips, solidifying the target analyte results in a visual output that identifies that the target analyte is present in the sample. Therefore, a scanner or user can identify whether there is a target analyte (e.g., corresponding to a condition or disease) in the sample based on the color of the test area.

[0036] "Target analyte", "analyte" or "analyte of interest" refers to a compound or component to be detected or measured from a sample, which has at least one epitope or binding site. The analyte can be any substance for which a naturally occurring analyte-specific binding member exists or for which an analyte-specific binding member can be prepared. Analytes include, but are not limited to, toxins, organic compounds, proteins, peptides, microorganisms, amino acids, nucleic acids, hormones, steroids, vitamins, drugs (including drugs administered for therapeutic purposes as well as drugs administered for illicit purposes), and / or metabolites or antibodies to any of the above. The term "analyte" also includes any antigenic substance, hapten, antibody, macromolecule and / or combinations thereof.

[0037] "Label" refers to any substance that is capable of producing a signal that can be detected by visual and / or instrumental means. Various labels suitable for use in the examples disclosed herein include labels that produce a signal by chemical and / or physical means. Examples include enzymes and substrates, pigments, fluorescent compounds, chemiluminescent compounds, colored or colorable organic polymer latex particles, liposomes, and / or other vesicles containing directly visible substances. In some examples, radioactive labels, colloidal metal particles, and / or colloidal non-metallic particles are used. In some examples, labels include colloidal gold and latex particles.

[0038] "Labeling material" or "binding substance" refers to a substance including a detectable label attached to a specific binding member. Attachment can be covalent or non-covalent, and can include nucleic acid hybridization. Labeling allows the labeling material to produce a detectable signal that is directly or indirectly related to the amount of analyte in the test sample. The specific binding member component of the labeling material is selected to bind directly or indirectly to the analyte.

[0039] "Specific binding member" refers to a member of a specific binding pair (e.g., two different molecules, one of which specifically binds to the second molecule by chemical or physical means). If the specific binding member is an immunoreactant, it can be, for example, an antibody, an analyte, an antigen, a hapten, or a complex thereof, and if an antibody is used, it can be a monoclonal or polyclonal antibody, a recombinant protein or antibody, a chimeric antibody, a mixture (multiple) thereof, or a fragment (multiple) thereof, as well as a mixture of an antibody and other specific binding members. Specific examples of specific binding members include biotin and avidin, antibodies and their corresponding antigens (both of which are unrelated to the sample to be assayed), single-stranded nucleic acids and their complementary sequences, etc.

[0040] A "test strip" or "LFA" may include one or more absorbent or non-absorbent materials. If the test strip includes more than one material, one or more materials are preferably fluidically connected. One material of the test strip may be overlaid on another material of the test strip, such as, for example, filter paper overlaid on nitrocellulose. Additionally or alternatively, the test strip may include a zone containing one or more materials (e.g., a medium), followed by a zone containing one or more different materials. In this case, the zones are fluidically connected and may or may not overlap each other partially. Suitable materials for the test strip include, but are not limited to, materials derived from cellulose, such as filter paper, chromatography paper, nitrocellulose, and cellulose acetate, and materials made of fiberglass, nylon, polyester, polyvinyl chloride (PVC), polyacrylamide, cross-linked dextran, agarose, polyacrylates, ceramic materials, and the like. One or more materials of the test strip may be optionally treated to modify their capillary flow properties or the properties of the applied sample. For example, the sample application zone of the test strip may be treated with a buffer to correct the pH value or specific gravity of the applied urine sample to ensure optimal testing conditions.

[0041] One or more materials can be a single structure, such as a sheet cut into strips, or it can be several strips or particulate materials bonded to a support or solid surface, such as, for example, found in thin layer chromatography, and can have an absorbent pad as an integral part or liquid contact. The material can also be a sheet with a lane thereon, which can be spotted to induce lane formation, wherein a separate assay can be performed in each lane. The material can have a rectangular, circular, oval, triangular or other shape, provided that the test solution has at least one traversing direction by capillary migration. Other traversing directions may occur, such as in an oval or circular piece contacted with the test solution at the center. However, it is primarily considered that there is at least one flow direction to a predetermined point. In the following discussion, the test strip will be described by way of example and not limitation.

[0042] In the case where the support is desired or necessary, the support of the test strip will be generally water-insoluble, often non-porous and rigid, but can be elastic, generally hydrophobic and porous, and generally the same length and width as the strip, but can be larger or smaller. The support material can be transparent, and when assembling the test equipment disclosed herein, the transparent support material can be on the side of the test strip that can be observed by the user, so that the transparent support material forms a protective layer above the test strip where the test strip may be exposed to the external environment, such as through the hole in front of the test equipment. A variety of removable and immovable materials, both natural and synthetic, and their combinations can be used, as long as the support does not interfere with the capillary action of one or more materials, or does not non-specifically combine the assay components, or does not interfere with the signal generation system. Exemplary polymers include polyethylene, polypropylene, poly (4-methylbutene), polystyrene, polymethacrylate, polyethylene terephthalate, nylon, polyvinyl butyrate, glass, ceramics, metals, etc. The elastic support can be made of polyurethane, chloroprene rubber, latex, silicone rubber, etc. Throughout the specification, descriptions of LFA should be understood as descriptions of LFA applicable to other types of test strips.

[0043] In some conventional LFAs, test results are displayed as subtle color changes, which leads to an increase in user errors when reading. For example, although the LFA may output a color corresponding to a positive result, if the color is dim and / or the lighting conditions are poor, the user may interpret the test as negative. In addition, because some conventional LFAs rely on visual cues to determine the results, the test lines corresponding to the results need to be sufficiently spaced and / or sufficiently limited to avoid confusion or reading errors. The examples disclosed herein generate a machine-readable improved LFA to provide objective and automatic result generation through an algorithm that reduces and / or otherwise eliminates false positives and / or false negatives due to human error. In addition, the use of an LFA that does not rely on visual cues allows more test areas to be closer together without the risk of misreading the results.

[0044] Because resources may be limited in certain areas of the world, dedicated LFA readers may be too expensive to use in those areas. Therefore, examples disclosed herein provide an improved LFA that can be read using a smartphone application as compared to a dedicated reader. While there are some smartphone applications that may be able to read the results of an LFA-based test, such smartphone applications may output inaccurate results due to poor lighting conditions, the LFA having a weak visual indicator, and / or poor quality sensors on the smartphone.

[0045] The examples disclosed herein generate improved LFA to solve traditional smart phone application errors and / or human errors corresponding to inaccurate results of traditional LFA readers. The examples disclosed herein provide signals corresponding to test results (e.g., one or more analog current and / or voltage values ​​corresponding to the test results, one or more digital current and / or voltage values ​​corresponding to the test results, one or more logic values ​​corresponding to the test results, etc.), which provide more accurate readings than analog systems. The examples disclosed herein correspond to machine-readable LFA devices that do not rely on traditional visual indicators to determine the results of fluid sample-based tests (e.g., LFA-based tests). In the examples disclosed herein, the improved LFA provides machine-readable results to smart phone applications. Therefore, the results are objective and readable, without manual interpretation, and there is no operator subjectivity, which increases the accuracy of the results. There is also no need to design and include a reading window on the LFA device. As further disclosed herein, the example LFA device does not need to accommodate a battery (e.g., a device that stores energy). For example, the LFA device is battery-free, is not connected to electricity by wires, and is powered by an electromagnetic field generated by a user device (such as a reader). In addition, accurate results can be easily transmitted to external databases and / or external servers, such as, for example, remote databases and / or servers located at or otherwise associated with electronic medical records (EMRs), government agencies, non-governmental organizations (NGOs), doctors' offices, hospitals, hospital information systems, laboratory information management software (LIMS) systems, inventory consumption monitors, clinics and / or other medical institutions, medical device manufacturers, medical organizations, health information systems and / or other external entities. In this way, large-scale test results can be generated, collected and digitally integrated into other healthcare systems to eliminate human-based transcription errors. The examples disclosed herein are also capable of self-testing, including, for example, self-testing by non-medical personnel, because untrained self-tester does not need knowledge about how to interpret the results. Self-testing can be incorporated into over-the-counter devices. The examples disclosed herein can be incorporated into disposable point-of-care devices.

[0046] Examples disclosed herein include LFA devices, which include wireless chips to obtain data corresponding to the presence or absence of analytes in samples based on electrical signals generated on LFA devices, and transmit the data to readers. The determination of the test result is based on the comparison of the electrical signal with one or more threshold values. The comparison can be performed on the wireless chip of LFA and / or on an external reader. In some examples, the wireless chip obtains analog current and / or voltage values ​​from electrodes placed in contact with the porous membrane of the LFA device, and transmits the analog current and / or voltage values ​​to the reader via an antenna. In this way, the reader can compare the analog value with one or more threshold values ​​to determine whether the test result is positive or negative. For example, if (multiple) current and / or voltage values ​​are higher than the threshold value, the reader determines that the test corresponding to (multiple) current and / or voltage values ​​is positive. Similarly, if (multiple) current and / or voltage values ​​are lower than the threshold value, the reader determines that the test corresponding to (multiple) current and / or voltage values ​​is negative. In some examples, the wireless chip obtains analog current and / or voltage values, converts the analog value into a digital value, and transmits the digital value to the reader. In this manner, the reader can compare the (multiple) digital values ​​to one or more thresholds to determine the test result. In some examples, the wireless chip obtains analog voltage and / or current values ​​and compares the values ​​(e.g., converted to digital values ​​or not converted to digital values) to one or more thresholds to generate a logic value (e.g., high or low) corresponding to a positive test or a negative test, and transmits the test result to the reader.

[0047] The examples disclosed herein include a variety of techniques for generating electrical signals indicating the presence or absence of an analyte of interest on an LFA device. For example, in order to obtain one or more electrical signals corresponding to one or more test results, the examples disclosed herein can utilize a bioelectrochemical mechanism (e.g., a device for generating energy) at the test and / or control line of the LFA device. As further described below, the bioelectrochemical mechanism includes a bioelectrochemical cell (e.g., a physical cell or a porous membrane is constructed as a physical cell), which generates an electrical signal at the porous membrane when the target analyte exists. The bioelectrochemical cell may be referred to as or otherwise include a potentiometer cell, a concentration cell, a fuel cell, a biofuel cell, etc. In some examples, the bioelectrochemical cell generates an electrical signal due to one or more bioelectrochemical reactions occurring on the porous membrane. The wireless chip of the LFA device can measure the electrical signal by sensing the current and / or voltage drop between the electrodes of the bioelectrochemical cell placed in contact with the porous membrane. In other examples, the LFA device may include a circuit completion mechanism at the test and / or control line of the LFA device to generate an electrical signal. As further described below, when the target analyte is present in the sample, the circuit completion mechanism generates a short circuit in the test area. For example, when the target analyte is present, the circuit completion mechanism can amplify the substance (e.g., silver) surrounding the solidified molecule (e.g., gold) in the test area. In this way, the wireless chip can generate a voltage and measure whether the current flows from one side of the test area to the other side (e.g., when a short circuit is created) to identify whether the target analyte is present.

[0048] In some examples of bioelectrochemical cells disclosed herein, half of the bioelectrochemical cell is attached to a test zone (e.g., a test line, a test zone, etc.) and / or a control zone (control line) of a porous medium (e.g., a membrane, paper, and / or other non-compartmental or non-compartmental matrix) of the LFA. In some examples, the bioelectrochemical cell can be a cell that has been treated with glucose and a redox substance (e.g., potassium ferrocyanide K3[Fe(CN)6] 3- , or ferrocene or a ferrocene derivative) and dried. In addition, the examples disclosed herein label (e.g., attach, couple, etc.) an enzyme (e.g., glucose oxidase (GOx)) that binds to an antibody analyte and / or antigen on a pad. In this way, if the antibody analyte and / or antigen coupled to GOx is attached to a target analyte, the immobilized antibody, analyte and / or antigen corresponding to the target analyte in the test area is attached and immobilized GOx. Because half of the bioelectrochemical cell is attached to the test area, GOx reacts with the solution of the bioelectrochemical cell to oxidize the glucose of the bioelectrochemical cell, as shown in the following chemical reaction processes 1-3, where (Ox) and (Red) refer to the reduced or oxidized state of the enzyme, respectively.

[0049] In addition, the following processes 4-5 illustrate chemical reactions, where the cofactors flavin adenine dinucleotide (FAD) and FADH2 refer to the oxidized or reduced state of the enzyme active center, respectively.

[0050] Although the examples disclosed herein refer to GOx as an enzyme for generating a product corresponding to the release / movement of an electric current and / or electrons (e.g., hydrogen peroxide (H2O2)), the examples disclosed herein may be implemented using additional and / or alternative enzymes. The examples disclosed herein may utilize amino acid oxidases, nicotinamide adenine dinucleotide phosphate (NADPH) oxidases, alcohol oxidases, galactose oxidases, and / or any other oxidases as enzymes for generating products (e.g., hydrogen peroxide) that promote the release and / or movement of electrons. In some examples, molecules other than glucose are included to promote the reaction of generating hydrogen peroxide, based on the enzyme used.

[0051] In some examples, an enzymatic reaction with a natural mediator (electron acceptor) (e.g., oxygen) can be used in a bioelectrochemical cell. In such an example, glucose is oxidized to gluconolactone, and FADH2 is oxidized to FAD, thereby producing a product (e.g., H2O2 (hydrogen peroxide)). Additionally or alternatively, glucose is oxidized by oxygen (e.g., oxygen is reduced) in the presence of glucose oxidase to produce C6H 12 O6 reacts with oxygen (O2) to produce C6H 10 O6 and H2O2 (e.g., hydrogen peroxide). In some examples, the electrodes can be made of metal (e.g., copper, titanium, brass, silver, platinum, etc.) graphite or screen-printed carbon electrodes doped with ferrocyanide. In this way, the product (e.g., H2O2) is reduced and oxidation of the metal or ferrocyanide of the electrode occurs by releasing electrons. In the latter case, ferrocyanide [Fe(CN)6] 4- With [Fe(CN)6] 3- reaction. The released electrons can be measured by a processor (e.g., using current and / or voltage measurements). The copper surface is typically oxidized by air to Cu2O (Cu(I)). By reduction with H2O2, Cu2O is oxidized to CuO (Cu(II)).

[0052] Because the product (e.g., hydrogen peroxide) is generated at the test line and / or control line, but is not solidified at the test line and / or control line, the product may begin to flow toward the wicking pad of the LFA device. Therefore, some examples disclosed herein may include a mechanism to prevent (e.g., slow down or stop) flow to keep the product or a portion of the product in a test area at or near the test and / or control line until the test is read. The mechanism to prevent flow can be used in any of the disclosed examples. Some examples disclosed herein slow flow by shearing, squeezing and / or cutting (e.g., partially or completely) a porous membrane to prevent flow. Such examples may include a mechanical device that a user can control to cut a porous membrane (e.g., move, slide, pivot, twist, rotate, etc.). Some examples disclosed herein apply a substance that is more viscous than a buffer (e.g., a chemical, glue, gel, etc.) to slow and / or stop flow. In some embodiments, after / during application of a mechanism to prevent flow, electrodes can be positioned to allow the product (e.g., hydrogen peroxide) to react with the electrode(s) to generate a strong electrical signal (e.g., corresponding to electron flow caused by the reaction) after the flow has stopped or has slowed.

[0053] In other examples, alternative reactions can be achieved with bioelectrochemical cells. For example, amperometric redox reactions without enzymes can be used in bioelectrochemical cells. For example, the amperometric signal of LFA can be measured without GOx enzymes because the gold of AuNP can act as a catalyst (for example, where the GOx in the conjugate is replaced by AuNP). In such examples, thiosulfate can be used to improve the signal, as shown in processes 6-8 below. In the following process 11, thiosulfate, ferrocyanide and KBr or KCl react, and AuNP will be catalytically reduced to ferrocyanide to produce electronic signals. KBr or KCl can be contained in a buffer and / or can be dried in a portion of a porous membrane and resuspended with a buffer.

[0054] Alternatively, the following process 9-11 illustrates an alternative chemical reaction for GOx-glucose oxidation. As shown in the previous process, oxygen can reactivate or reoxidize GOx to its active form. Although method 9-11 is described in conjunction with ferrocyanide, method 9-11 can also be used with other substances (e.g., quinones, ferrocene, osmium complexes, etc.) in oxidized form. Quinones, ferrocene, osmium complexes, etc. can be contained in a buffer and / or can be dried in a portion of a porous membrane and resuspended with a buffer.

[0055] Processes 4 and 11 result in a decrease in the pH level of the solution (e.g., to an acidic state in the case of a low buffer system), which corresponds to an electromotive force relative to an electrode placed near the test line of the LFA, where no GOx reaction occurs. In low concentration buffer solutions, a change in pH will occur and result in a measurable Nernst voltage and / or current.

[0056] In the redox cycle of GOx, one electron can be transferred to convert [Fe(CN)6] 3- Reduced to [Fe(CN)6] 4- The ferrocyanide molecules act as electron mediators and can eventually diffuse to the electrodes. The concentration difference between the electrode at the top of the cell and the electrode at the bottom of the cell produces the cell voltage described by the Nernst equation, and / or Therefore, when there is a target analyte in the sample, the porous medium is combined with cells and / or electrodes to generate an electrical signal (e.g., voltage or current). The examples disclosed herein measure the voltage and / or current (e.g., from one half to the other half) from the battery, which corresponds to the current through the potentiometer battery to determine whether the test is positive (e.g., the corresponding target analyte is present in the sample) or negative (e.g., the corresponding target analyte is not present in the sample), thereby eliminating the need for a visual indicator. When implementing a bioelectrochemical cell, in addition to the examples listed above that can be used additionally or alternatively, other combinations of elements and / or reducing agents can also be present. The LFA that utilizes the reaction of detecting ions in the solution based on the electric current or the charge in the electric current (e.g., amperometric measurement) is referred to herein as an amperometric-based LFA. The LFA that utilizes the detection of the potential difference between the two electrodes (e.g., a potentiometer measurement generated by a redox reaction) is referred to herein as an LFA based on a potentiometer.

[0057] In some examples disclosed herein, the medium (e.g., membrane, paper, and / or matrix) of the lateral flow immunoassay device can act as a bioelectrochemical cell. For example, instead of using paper dried with glucose and redox substances to act as a bioelectrochemical cell. Liquid assay buffers can be applied to lateral flow immunoassay devices, which include glucose and redox substances. In some examples, the buffer can dilute the sample and include glucose and redox substances to promote reactions that produce current or voltage. In such examples, the membrane of the lateral flow immunoassay device acts as a salt bridge. In this way, if the solidified antibody analyte and / or the antigen corresponding to the target analyte of the test zone is attached to solidify GOx, GOx will react with the glucose and redox substances of the assay buffer to diffuse electrons to the zone of the medium outside the test zone, thereby generating voltage and / or current. Therefore, the bioelectrochemical cell is based on the target zone and the zone outside the target zone. Therefore, the first electrode can be placed in the test zone, and the second electrode can be placed in the zone outside the test zone, and the voltage and / or current between the two test zones can be measured to determine whether the target analyte exists. As used herein, a bioelectrochemical cell is a cell that converts the chemical energy of a fuel and a reagent (e.g., an oxidant) into electricity through a pair of redox reactions. The bioelectrochemical cell can be a biofuel cell (e.g., a fuel cell that uses an enzyme as a catalyst to oxidize its fuel), a concentration cell (e.g., an electrolytic cell comprising two half-cells with the same electrodes that produce a voltage and / or current when the two half-cells have different concentrations (e.g., a GOx glucose reaction occurs at one electrode and no reaction occurs at the other electrode)), a galvanic cell (e.g., comprising two different metals immersed in an electrolyte connected by a salt bridge or a porous medium), and / or any other cell that converts chemical energy into electricity.

[0058] As described above, in some examples, the LFA device can use a circuit completion mechanism on the test and / or control line of the LFA device to generate or measure an electrical signal corresponding to the test result. For example, the machine-readable LFA device has a test area that acts like an electrical switch. In such an example, the conjugate pad includes gold nanoparticles labeled with antibody analytes and / or antigens corresponding to the target analyte. In this way, if the sample includes the target analyte, the target analyte is attached to the gold-labeled antibody, analyte and / or antigen, and is solidified in the test area by the corresponding solidified antigen, analyte and / or antibody. An autocatalytic silver enhancer (e.g., silver ions and a reducing agent, such as hydroquinone, aminophenol, ascorbic acid) is applied to the test area so that the silver reacts with the gold and expands in size. When the silver amplification exceeds a certain size, the enlarged silver on each gold nanoparticle attached to the test area contacts each other, thereby generating a connection, increased conductivity, reduced resistance, and / or a short circuit between electrodes. The examples disclosed herein can apply an electrical connection to each side of the test area and apply a voltage to one side of the electrical connection. If the target analyte is present, the silver amplifies to create a connection, increased conductivity, reduced resistance, and / or a short circuit, and the application of voltage causes current to flow from one electrical connection to another. Thus, the examples disclosed herein determine the presence of a target analyte in a sample (e.g., corresponding to a positive test result) by measuring a signal (e.g., current and / or resistance between electrical connections to the test wires (e.g., the resistance of a short circuit is low, and the resistance of an open circuit is high (infinity)). If the measurement signal has a current above a current threshold or a corresponding resistance below a resistance threshold, the examples disclosed herein mark the test as positive for the corresponding target analyte, and if the measurement signal has a current below a current threshold or a corresponding resistance above a resistance threshold, the examples disclosed herein mark the test result as negative for the corresponding target analyte, thereby eliminating the need for a visual indicator.

[0059] Alternatively, the silver amplification reaction (reduction of silver by oxidation of the reducing agent to release electrons e - and proton H + , the proton H + Recombines with H2O to form H3O + ) produces H3O + ions, which change the pH of a poorly buffered reaction solution. A bioelectrochemical cell in which silver amplification occurs in the upper portion of the cell, generating a voltage described by the Nernst equation Where cell2 and cell1 (cell2 = top cell, cell1 = bottom cell) refer to the H3O + The concentration of ions. The voltage and / or current of the battery can be measured by the wireless chip.

[0060] Because the LFA device can correspond to one or more specific durations for which a user should take specific actions (e.g., the duration of applying a sample and / or buffer, the duration of obtaining a result after applying a sample, the duration of scanning the LFA device with a reader, the duration of moving a mechanical part of the LFA device, etc.), the examples disclosed herein include mechanisms and processes for tracking time and / or guiding a user to perform one or more steps. For example, after applying a sample and / or buffer to the LFA, a user may need to wait for a first duration before obtaining a result. The examples disclosed herein may include a timer at the LFA device and / or reader for tracking (multiple) durations to guide the user through the testing process. In some examples, the timer is powered by current and / or voltage generated by a bioelectrochemical cell. In some examples, the LFA device can send timing information to the LFA reader, and the LFA reader can display and / or otherwise indicate one or more durations to the user. In some examples, the LFA reader can track duration based on confirmation from the user and instruct the user when to perform a particular task to ensure that the task is not performed too early or too late (e.g., reading results too early or too late, scanning the LFA too early or too late, adjusting the LFA device too early or too late, etc.). By providing a reader to guide the user through the test product, the LFA device can be operated by less trained users and / or can be performed by users with less education levels. In addition, the reader can be implemented by the patient to perform self-tests by following the instructions presented on the reader.

[0061] Figure 1A 1 is an example environment 100, including an example machine-readable LFA generator 102 for generating an example machine-readable LFA chip, strip, or LFA device 104 (shown in top view). The example machine-readable LFA device 104 includes an example sample pad 106, an example conjugate release pad 108, an example porous medium 109, an example test area 110, an example bioelectrochemical cell 111a-n, an example wicking pad 112, an example inlet 113, an example wireless chip 114, and an example antenna 115. Figure 1A The environment 100 also includes an example user device or reader 116 to determine test results (e.g., diagnostic test results) of samples applied to the example machine-readable LFA device 104. The example reader 116 includes an example machine-readable LFA reader application 117, an example antenna 118, and an example user interface 120. Although Figure 1A The example of determining the test results based on the bio-electrochemical cells 111a-n, but Figure 1A The description may be combined with other techniques for determining test results based on electrical signals, as further disclosed herein.

[0062] Figure 1AThe exemplary machine-readable LFA generator 102 generates the exemplary machine-readable LFA device 104 (and / or Figure 3A 1 ). For example, the machine-readable LFA generator 102 generates the machine-readable LFA device 104 to include an example sample pad 106, an example conjugate release pad 108, an example porous medium 109, an example test area 110, an example bioelectrochemical cell 111a-n, an example wicking pad 112, an example inlet 113, an example wireless chip 114, an example antenna 115, and / or leads or etchings contained in a housing structure (not shown). The number of tests, the type of test (e.g., pregnancy, Ebola, HIV, flu, covid, cancer, sexually transmitted disease (STD), etc.), the number of control areas, the type of control area (e.g., positive control, negative control, etc.), and / or the type of machine-readable LFA are based on instructions from a user and / or a manufacturer. For example, if the user desires that the exemplary machine-readable LFA device 104 include a single test for pregnancy, the machine-readable LFA generator 102 generates the exemplary conjugate region to include antibodies, analytes, and / or antigens corresponding to a target analyte corresponding to pregnancy, antibodies, analytes, and / or antigens labeled with specific molecules (e.g., gold nanoparticles, GOx, etc.). In such an example, the machine-readable LFA generator 102 generates the test region 110 to include immobilized antibodies, analytes, and / or antigens to bind or otherwise attach to the target analyte and a bioelectrochemical cell (e.g., paper impregnated with an enzyme substrate (e.g., glucose) and / or a reducing agent (e.g., hydroquinone, aminophenol, vitamin C (e.g., ascorbic acid contained in vitamin C)), etc.), and / or an electron mediator or redox substance (e.g., potassium ferrocyanide, ferrocene, oxygen, a ferrocene derivative, etc.), which includes a first half attached to the test region 110. Additionally, the example machine-readable LFA generator 102 generates or otherwise attaches a wireless chip 114 to attach to a bioelectrochemical cell to determine whether a sample (eg, a biological sample) is positive or negative for a target analyte corresponding to pregnancy. Figure 4 An exemplary machine-readable LFA generator 102 is further disclosed.

[0063] Figure 1A The exemplary machine-readable LFA device 104 of the present invention is a bioelectrochemical cell-based LFA (e.g., a concentration cell with Nernst voltage sensing) including exemplary bioelectrochemical cells 111a-n. However, the machine-readable LFA device 104 may be an alternative device capable of obtaining data related to the test results on the LFA 104. For example, as described below in conjunction with Figure 3AFurther disclosed, the exemplary machine-readable LFA device 104 may alternatively be a circuit-complete LFA device (e.g., by electrically shorting the test wires with low resistance). In some examples, the exemplary machine-readable LFA device 104 is a non-visual indication biosensor device. For example, the LFA device 104 may not output a visual indication to a user (e.g., because gold nanoparticles are not present on the device) and / or the visual indication is not visible to the user (e.g., because the housing covers a porous medium that can enable visual indication). In some examples, the LFA device 104 is a non-visual indication circuit-complete device. In some examples, the LFA device 104 is a visual indication circuit-complete device and / or a biosensor device that provides a visual indication of a result and is capable of wirelessly transmitting the result to a reader. The LFA device 104 can be a point-of-care device and / or a rapid diagnostic device that includes an application-specific integrated circuit (e.g., the exemplary wireless chip 114).

[0064] Figure 1A The exemplary machine-readable LFA device 104 is a device including a sample pad 106 (e.g., a sample pad, a sample section, a sample area, a sample zone, etc.). For example, the LFA device 104 can be a porous membrane device, a porous medium device, a fluid transport medium device, a test strip device, a lateral flow test strip device and / or any fluid sample device. The sample pad 106 is configured to act as a sponge to keep the fluid sample applied to the sample pad 106. In some examples, the sample pad 106 includes a buffer component (e.g., a salt, a surfactant, etc.) to ensure that the target analyte that may be in the sample can be combined with the component of the conjugate release pad 108. When the sample pad 106 is soaked, the fluid maintained in the sample pad 106 flows to the conjugate release pad 108. The conjugate pad 108 includes a marker material or a conjugate configured to bind the target analyte. For example, the conjugate release pad 108 includes a conjugate or a detector (e.g., an antibody specific to one or more target analytes) labeled with a detectable marker, a label, a linker, an antibody, an analyte, an antigen, GOx, a gold nanoparticle, etc. The target analyte is a component that corresponds to a specific condition or disease. Thus, the presence of the target analyte in the sample corresponds to the presence of the corresponding condition and / or disease in the patient providing the sample. If the sample includes one or more target analytes, a conjugate and / or detector labeled with GOx, gold nanoparticles, etc. is attached to the corresponding target analyte. The sample (e.g., including the detector if the corresponding target analyte is present in the sample) continues to flow through the example porous medium 109 of the machine-readable LFA device 104 to the wicking pad 112.

[0065] When the sample flows through Figure 1AThe sample flows through the test area 110 while the medium 109 of LFA 104 is being passed through. The medium 109 can be a porous membrane, a nitrocellulose membrane, paper and / or other matrix, including a non-compartmental matrix, etc., which propagates the flow of biological samples and / or liquid buffers. The test area 110 includes a test area (e.g., a test line, a test area, a test area portion, etc.) and / or a control area (e.g., a control line, a control area, a control area portion, etc.). The test area includes a specific solidified antibody, analyte or antigen, which reacts with a corresponding target analyte attached with a detector and / or a binder. Therefore, when the target analyte corresponding to a specific test area is present in the sample, GOx and / or gold nanoparticles are solidified in the specific test area. In some examples, the test areas of LFA 104 correspond to different conditions or diseases, which is called multiplexing. Multiplexing includes constructing multiple test areas or test lines to detect multiple markers (e.g., multiple types of antibodies / antigens / analytes) in one sample. For example, multiplexing technology can be applied to a single diagnostic test that can test for multiple types of sexually transmitted diseases. In some examples, the test area 110 includes a control zone that solidifies a specific and / or excess binder flowing through the control zone. The control zone corresponds to a target that has dried into the porous medium 109 to indicate that the test is ready to be read (eg, when the test is complete).

[0066] Figure 1A The testing area 110 also includes example bioelectrochemical cells 111a-n (eg, concentration cells). Figure 1A A portion of a bioelectrochemical cell 111a-n is shown. Other portions are shown in Figure 1B-2Eand / or 2I-2K. In some examples, the potentiometer cells 111a-n are paper or other matrices impregnated with enzyme substrates (e.g., glucose) and / or reducing agents (e.g., hydroquinone, aminophenol, ascorbic acid contained in vitamin C, etc.) and / or electron mediators or redox substances (e.g., potassium ferrocyanide, ferrocene, oxygen, ferrocene derivatives, etc.). However, the bioelectrochemical cells 111a-n can be any type of bioelectrochemical cells, as described above in conjunction with the above processes 1-11. When GOx (which oxidizes glucose) or gold nanoparticles (via self-catalyzed silver nitrate reduction (e.g., vitamin C and / or another reducing agent)) are attached to the test area and / or the control area, the corresponding bioelectrochemical cells 111a-n are activated by generating a voltage according to the Nernst equation, which can be read via the wireless chip 114. Thus, the wireless chip 114 uses the example bioelectrochemical cells 111a-n to perform bioelectrochemical measurements, wherein the wireless chip 114 passively measures the potential between two different parts of the biofuel cell 111a-n using two electrodes. In some examples, during manufacturing, the bioelectrochemical cells 111a-n are fluidically coupled (e.g., attached) to the test and / or control area. In some embodiments, during manufacturing, the bioelectrochemical cells 111a-n are separated from the test and / or control area, and the example LFA device 104 includes a mechanical device to automatically and / or manually press the bioelectrochemical cell into contact (e.g., fluid contact) with the test and / or control area when a test is to be performed (e.g., automatically and / or manually press the bioelectrochemical cell into contact with the area through user intervention when a sample is applied to the LFA 104).

[0067] Figure 1A The testing area 110 also includes an example wicking pad 112 . Figure 1A An example wicking pad 112 is an absorbent material that wicks liquid through the LFA. In some examples, the wicking pad 112 includes a cellulose filter. The wicking pad 112 prevents liquid from flowing back. In addition, in some examples, the wicking pad 112 acts as a waste container.

[0068] The test area 110 also includes Figure 1A Entrance 113. Figure 1AThe example inlet 113 is configured to allow water or another buffer solution applied to the sample pad 106 to flow to the wicking pad 112. In some examples, the water and / or buffer is encapsulated in a retaining device (e.g., a frangible housing such as a bag), and the user presses and / or moves a component of the LFA device 104 to cause the retaining device to release the buffer (e.g., by breaking the bag). In some examples, the sample pad 106 can be more than one sample pad (e.g., one for the sample and another for the water / buffer and / or additional reagents). As the water and / or buffer flows through the bioelectrochemical cells 111a-n, if the test and / or control regions are already attached to GOx and / or gold nanoparticles (e.g., based on mixing of the conjugate with an enzyme substrate, a reducing agent, and / or an electron mediator of the bioelectrochemical cells 111a-n), the water and / or buffer resuspends the dried reagents to cause current to flow. The first portion of the bioelectrochemical cells 111a-n (e.g., Figure 2A The top of the second part (e.g. Figure 2A The center area between the bottom of Figure 2A The constriction region in the test zone (in the test zone) acts as a diffusion-induced homogenized salt bridge for the concentration gradient, thereby causing electrons lost in the first portion of the bioelectrochemical cell 111a-n (e.g., due to reactions occurring when the target analyte and the corresponding conjugate are suspended in the test zone or the control zone) to flow to the second portion of the bioelectrochemical cell 111a-n, which corresponds to a measurable voltage drop and / or current from the first portion of the bioelectrochemical cell 111a-n to the second portion of the bioelectrochemical cell 111a-n. Additionally or alternatively, the paper / membrane type can reduce diffusion.

[0069] The exemplary machine-readable LFA device 104 also includes an exemplary wireless chip 114. The wireless chip 114 is a near field communication (NFC) chip. Therefore, the wireless chip 114 can obtain power and / or communicate with the reader 116 via the NFC communication protocol. Alternatively, the exemplary wireless chip 114 can be a radio frequency identification (RFID) chip or any other type of wireless chip. The wireless chip 114 includes pins coupled to a connector (e.g., leads, etching, etc.), which are coupled to electrodes (e.g., directly or via a front-end device, as further described below). The electrodes are connected to both ends of each bioelectrochemical cell 111a-n and / or different parts of the porous membrane 109. In this way, if the bioelectrochemical cell 111a-n generates a voltage and / or a current, the voltage drop and / or current between the two electrodes (e.g., connected to opposite sites of the bioelectrochemical cell or placed at different locations on the porous membrane 109) will be higher than a threshold. In some examples, the generated voltage and / or current can be used to power the wireless chip 114 (e.g., to provide power for storing test results at the wireless chip 114). The example wireless chip 114 includes hardware, software, and / or firmware capable of measuring current, electromotive force, or voltage drop and / or current to determine whether the target analyte is present in the sample. The wireless chip 114 may include an ASIC to encode manufacturing and / or identification information. The example wireless chip 114 is powered by the example antenna 115. When the example reader 116 generates a magnetic field within a threshold distance to the example antenna 115, a current is generated at the antenna 115, and the corresponding energy is used to power the wireless chip 114. The energy can be used to provide a voltage to power the wireless chip 114. In some examples, the voltage is (e.g., 1.8 volts (V)). In other examples, the voltage can be of different magnitudes, including, for example, 3.3V, 5V, etc. Once powered, the wireless chip 114 can operate. For example, in operation, the wireless chip 114 can apply a potential. In some examples, the wireless chip 114 operates to measure voltage, current, and / or resistance, etc. Additionally or alternatively, in some examples, the wireless chip 114 operates to transmit identification information (e.g., device identifier, test identifier, serial number, product code, etc.) to an exemplary reader 116 and / or may transmit measurement values ​​corresponding to test results (e.g., analog and / or digital values ​​corresponding to voltage and / or current measurements obtained at the LFA device 104). In some examples, communications between the wireless chip 114 and the reader 116 are encrypted using encryption techniques known to both the wireless chip 114 and the reader 116. In some examples, the wireless chip 114 may mark each test zone and / or control zone as positive or negative based on the measured current, electromotive force, and / or voltage drop. Further, in some examples, the wireless chip 114 stores the results corresponding to the (multiple) flags, and / or transmits the results using the antenna 115.Additionally, the example wireless chip 114 can transmit, along with the results, identification information corresponding to an LFA identifier, an identifier of a test and / or control zone, etc. In some examples, the wireless chip 114 is coupled to a circuit-based implementation of LFA. Figure 1A The example includes an example wireless chip 114 as part of the example LFA 104, but the wireless chip can be integrated in an external device. In such an example, the LFA 104 can include a component (e.g., an interface) that allows the electrodes of the LFA 104 to be connected to the wireless chip 114. In this way, the design of the LFA 104 can be simplified to reduce the size and / or cost of the LFA 104, and multiple LFAs can be connected to the wireless chip 114 to transmit test results to the example reader 116. Figure 3A Further disclosed is the operation of the wireless chip 114 in conjunction with the circuit-based LFA. Figure 5 An example wireless chip 114 is further disclosed.

[0070] Figure 1A The example reader 116 is a smartphone that includes a machine-readable LFA reader application 117, an example antenna 118, and an example user interface 120. Alternatively, the example reader 116 may be a tablet, a personal digital assistant, a laptop, a standalone LFA reader device, and / or any other processing device that includes or otherwise communicates with the example machine-readable LFA reader application 117, the example antenna 118, and / or the example user interface 120. The example machine-readable LFA reader application 117 is an application that may be installed, downloaded, and / or encoded within the example reader 116. In some examples, the example machine-readable LFA reader application 117 may be supplied via a near field communication tag or a Bluetooth device.

[0071] In some examples, the reader 116 may be divided into multiple readers. In such an example, the first reader 116 obtains information from the LFA 104 and guides the user through the process of utilizing the LFA 104, and the second reader 116 obtains the test results from the LFA 104. For example, in a hospital, hospital information system, LIMS system, inventory consumption monitor, clinic, testing site, etc., the first reader may guide the first user to use the first LFA reader to obtain a sample, and once the sample is obtained, the first reader may communicate with the second reader to send the LFA device information and start a timer at the second reader when the test is ready. In this way, the first user can provide the LFA device to the second user, and the second user can scan the LFA device using the second reader when ready.

[0072] Figure 1AThe exemplary machine-readable LFA reader application 117 instructs components of the reader 116 to generate electromagnetic signals at various points in time to (a) obtain identification information from the LFA device 104 at a first time, (b) obtain identification information from the LFA device 104 at a second time before obtaining the result to verify that the correct device is being read, and (c) obtain the result (e.g., one or more digital voltages and / or currents corresponding to the result) from the LFA device 104. The exemplary LFA reader application 117 causes the electromagnetic field to be generated at the second time to verify the identification information, thereby ensuring that the user is reading the test from the correct LFA device (e.g., when reading multiple tests simultaneously). The exemplary machine-readable LFA reader application 117 identifies the result of the LFA-based test by interacting with the wireless chip 114 (e.g., receiving a wireless signal identifying the result of the test). For example, the machine-readable LFA reader application 117 controls components of the reader 116 to obtain identification information and / or test results corresponding to the machine-readable LFA device 104 via NFC, RFID, etc. signals transmitted from the wireless chip 114. In some examples, the LFA reader application 117 determines information based on the obtained identification information. For example, the LFA reader application 117 may determine whether a test has been read, the type of test being performed, an algorithm used to identify and / or classify the results of a test, whether a test has expired or been recalled, and the like. The algorithm (e.g., corresponding to how and when to read one or more electrical signals from a particular LFA device) may be stored locally at the reader 116 and / or may be remotely configured (e.g., via a patch, update, remote instruction, etc.), reconfigured, updated, and the like. Once the test results (e.g., samples from the LFA device 104) are obtained, the machine-readable LFA reader application 117 determines whether the test is ready (e.g., based on a flag corresponding to a control zone), and if ready, determines the results of the test based on a corresponding algorithm (e.g., using voltage and / or current samples from the test lines), and displays the results using the example user interface 120, stores the results in a local database, and / or transmits the results to a monitoring entity for monitoring and / or statistical analysis. In this way, a manufacturer or other party can process the results, perform diagnostics, and / or identify whether a particular LFA device may be counterfeit (e.g., whether more than a threshold number of results corresponding to the same identification information have been determined). In some examples, the LFA reader application 117 transmits raw data. In some examples, the LFA reader application 117 obtains (e.g., from the wireless chip 114) and / or determines (e.g., based on the identification information from the wireless chip 114) various other contextual information, including batch number, expiration date, deadline, testing information, signal quality information, chain of custody, etc. Additionally or alternatively, in some examples, the LFA reader application 117 transmits processed data or data resulting from one or more levels of analysis. In conjunction with Figure 6 An exemplary machine-readable LFA reader application 117 is further disclosed.

[0073] Figure 1A The example antenna 118 of the example reader 116 wirelessly powers and / or communicates with the example wireless chip 114 (e.g., via the example antenna 115). For example, based on instructions from the example machine-readable LFA reader application 117, the antenna 118 transmits a magnetic field to power the example wireless chip 114, and receives wireless information (e.g., an identifier, test results, etc.) from the example wireless chip 114.

[0074] Figure 1B yes Figure 1A A side view of an LFA assembly of an LFA device 104 is shown. Figure 1B include Figure 1A The example sample pad 106, the example conjugate pad 108, the example porous medium 109, the (multiple) parts of the example bioelectrochemical cells 111a-111n and the example waste pad 112. Figure 1A As described, exemplary bioelectrochemical cells 111a-n are connected via electrodes to Figure 1A An exemplary wireless chip 114 of .

[0075] Figure 2A Shows that when the Figure 1A When the exemplary bioelectrochemical cells 111a-n are used to generate electrical signals corresponding to a test analysis performed by an enzyme reaction, Figure 1A An exemplary embodiment of a portion of a machine-readable LFA device 104 . Figure 2A Examples include Figure 1A Example porous media 109, example bioelectrochemical cells 111a-d (eg, corresponding to Figure 1A 11a-n), an example inlet 113, an example wireless chip 114, and an example antenna 115. Although the example porous medium 109 has two control lines, two test lines, and four bioelectrochemical cells 111a-d, the porous medium 109 can have any number of test lines, control lines, and / or bioelectrochemical cells. Additionally or alternatively, other techniques (e.g., circuit completion techniques, using the porous membrane 109 as a bioelectrochemical cell, etc.) can be used to obtain an electrical signal corresponding to the test result, as further described below.

[0076] Figure 2AThe example porous medium 109 is composed of two test lines (e.g., T1 and T2) and two control lines (e.g., positive control (PC) and negative control (NC)). The negative control line includes solidified antibodies and / or antigens to couple to corresponding target analytes, and when the sample is applied to the sample pad 106, the target analyte is coupled to the solidified antibodies. The negative control line is controlled to verify that the current generated by the attached bioelectrochemical cell 111d is strong enough for a valid test measurement. In order for the test to be valid, the amount of voltage and / or current on the bioelectrochemical cell 111d passing through the negative control line should be below a threshold.

[0077] The positive control line includes solidified antibodies, analytes and / or antigens, which are coupled to specific and / or excess conjugates labeled with GOx and / or gold nanoparticles and / or detectors labeled with GOx and / or gold nanoparticles, which flow from the conjugate pad 108 to the wicking pad 112. When the sample flows to the wicking pad 112, the positive control line is the last segment attached to the conjugate and / or detector, resulting in the voltage and / or current generation of the bioelectrochemical cell 111a. In this way, when the voltage and / or current measurement of the bioelectrochemical cell 111a produces a positive (e.g., greater than a threshold amount of voltage and / or current), the reader 116 knows whether the test is ready. Example test lines T1 and T2 each have solidified antibodies, analytes and / or antigens corresponding to different target analytes. Therefore, if the target analyte of T1 is present in the sample, the target analyte (which is attached to the conjugate antibody, analyte and / or antigen labeled with GOx and / or silver nitrate) is solidified on the T1 line.

[0078] Figure 2A An example bioelectrochemical cell 111a-d is a piece of paper that has been impregnated with a redox substance (e.g., (i) potassium ferrocyanide and (ii) (a) glucose or (b) ascorbic acid) and dried. In some embodiments, the bioelectrochemical cell 111a-d is not initially attached to the porous medium 109, and the housing includes a mechanical device that automatically and / or manually presses the bioelectrochemical cell into contact with the porous medium 109 for testing. In other examples, the bioelectrochemical cell 111a-d is initially attached to the porous medium 109. Although the lower half of the bioelectrochemical cell 111a-d is coupled to the wireless chip 114 via a single pin, the lower half of the bioelectrochemical cell 111a-d can be coupled to the wireless chip 114 via four separate pins.

[0079] Figure 2AThe example inlet 113 allows water or a buffer solution to resuspend the dried reagents of the bioelectrochemical cell being tested. Thus, before, during, and / or after the sample is added to the sample pad 106, the user applies water and / or a buffer solution to the sample pad 106 and / or a separate sample pad, and the water and / or buffer solution flows through the inlet and resuspends the dried reagents of the bioelectrochemical cells 111a-d. In this way, the middle portion of the bioelectrochemical cells 111a-d acts as a salt bridge for homogenization of the concentration gradient caused by diffusion. This allows GOx (if solidified on a test or control line) to oxidize the glucose of the corresponding bioelectrochemical cell 111a-d. Alternatively, this can allow silver nitrate to oxidize the ascorbic acid of the corresponding bioelectrochemical cell 111a-d to allow the reducing agent (e.g., ascorbic acid) to release H + (H3O + ) to reduce silver nitrate. If one half-cell of one or more of the bioelectrochemical cells 111a-d is oxidized during the redox cycle of GOx, electrons can be transferred to convert [Fe(CN)6] 3- Reduced to [Fe(CN)6] 4- The ferrocyanide molecule acts as an electron mediator and can eventually diffuse to the electrodes. The concentration difference between the top and bottom cells produces the cell voltage described by the Nernst equation In some examples, electron flow, current, voltage, electromotive force, and / or corresponding resistance may be measured by the example wireless chip 114 .

[0080] Figure 2A The exemplary antenna 115 is constructed around the other components of the exemplary machine-readable LFA device 104. The connection between the bio-electrochemical cells 111a-d and / or the wireless chip 114 and the antenna 115 may be achieved by wires or etching.

[0081] Figure 2B Shows Figure 1A The LFA device 104 Figure 2A An alternative embodiment of the example antenna 115 is shown in FIG. Figure 2B In the example of FIG. 1 , the antenna is constructed in a dedicated space (as opposed to around components of the machine-readable LFA device 104). Additionally or alternatively, the example antenna 115 may be constructed in a different configuration.

[0082] Figure 2C Shows Figure 1A The LFA device 104 Figure 1A , 1B , 2A, and / or 2B of one or more of the bioelectrochemical cells 111a-n. Although Figure 2CSix different embodiments 200a-200f are shown, but other embodiments of bioelectrochemical cells 111a-n are possible. One or more of the bioelectrochemical cells 111a-n can be implemented as a combination or topological variation of one or more of the example embodiments 200a-200f. For example, embodiment 200f can include any number of meanders between the first portion and the second portion of embodiment 200f. Alternatively, the porous membrane 109 can act as a bioelectrochemical cell, as shown below in combination with Figure 2D Further described.

[0083] Figure 2D Shows Figure 1A An alternative exemplary embodiment of a top view of a porous medium 109 of a machine-readable lateral flow immunoassay 104 for generating an electrical signal corresponding to a test analyte through an enzymatic reaction. Figure 2D As shown, the porous medium 109 includes a positive control zone (PC), a test zone (T1), and a negative control zone (NC). Additionally or alternatively, the porous medium 109 may include any number and / or type of control zones and / or test zones. Figure 2D The example porous medium 109 includes an example membrane compression or cutout 201, and example electrodes 202a-202f corresponding to different zones. Figure 2DThe example electrodes 202a-f of the present invention have different widths, but the example electrodes 202a-f can have the same width and / or be configured to any width. The width of the electrodes 202a-f can be based on the geometry of the porous membrane 109, the size of the salt bridge between the working electrode (e.g., electrode 202a) and the reference electrode (e.g., electrode 202b), the overlap outside the specific test area and reference area, etc. In some examples, the electrodes 202a, 202c, 202e are wider than the electrodes 102b, 102d, 102f (e.g., reference electrodes), and the electrodes 202a, 202c, 202e are wider than the test strip to allow for the most flexible positioning tolerances during assembly and manufacturing / printing of the test strip. The spacing between the working electrode and the counter electrode pair [electrode 202a, reference electrode 202b], [electrode 202c, reference electrode 202d], [electrode 202e, reference electrode 202f] is as small as possible (e.g., 10 nanometers (nm) to 5 millimeters (mm), but can be as small as 1 nm). Example electrodes 202a-202f can be silver carbon electrodes, copper electrodes, graphite carbon electrodes, titanium electrodes, brass electrodes, platinum and palladium electrodes, screen-printed carbon electrodes doped with ferrocyanide or any other oxidizable material or electron donor, and / or any other type of electrode. In some examples, electrodes 202a, 202c, 202e are copper electrodes, and the reference electrode is a carbon electrode. By using a pair of electrodes (e.g., a working electrode and a reference electrode) for a single test line and / or control line, a salt bridge with a low impedance amount can be generated between a pair of electrodes on the porous membrane 104. In this way, the voltage and / or current between the electrode pair can be read without using an external power supply to facilitate the generation of the voltage and / or current. In some examples, the electrodes 202a-202f are not engaged with the porous medium 109 until it is time to read the results. Thus, one or more mechanical devices may be used to keep the electrodes 202a-202f disengaged (e.g., not in contact) with the porous medium 109 until it is time to read the results. Figure 2N-2R Further disclosed are examples of one or more mechanical devices that engage and / or disengage the electrodes 202a - 202f from the porous medium 109 .

[0084] In some examples, the voltage regulator and / or driver of the wireless chip 114 can apply a potential (e.g., voltage, bias, etc.) at one or more ends of the electrodes 202a-202f to help, promote and / or improve one or more chemical reactions that will occur on the porous membrane 104. In some examples, the applied potential is a poise potential or a balance. Applying a potential to (multiple) electrodes promotes and / or triggers a chemical reaction (oxidation and / or reduction) to obtain a stronger signal corresponding to the presence of a target analyte. Stronger signals include, for example, increased current signal amplitude, more stable polarity, reduced signal extension, greater signal-to-noise ratio and / or higher sensitivity (e.g., from 0.001% to 0.01%). For example, when the target analyte is present, the balance or potential affects the chemical reaction to allow more electrons to flow. For example, the penetration of the electrons of the analyte through the electrode surface is related to the applied potential (e.g., resulting in a qualitative analysis). Therefore, the applied potential forces the copper of the electrode to react from an oxidized form to a reduced form. In some examples, the amount of balance, bias and / or voltage can force and / or assist different parts of the chemical reaction. Thus, in some embodiments, when the target analyte is present, one or more balances and / or voltages may be applied to assist in one or more chemical reactions that generate an electrical current. The application of potentials and / or balances results in increased sensitivity and / or greater signal robustness. As further described below, the driver and / or voltage regulator of the wireless chip 114 adjusts the voltage (e.g., 1.8V, 3.3V, 5V, etc.) generated by the antenna (e.g., via the electromagnetic field generated by the reader 116) to one or more smaller voltages (e.g., 150mV, -100mV, -200mV, etc.), which may be used to apply one or more voltages (e.g., equilibrium potentials) to the electrodes 202a-202f, thereby increasing the signal strength of the current / voltage measured when the target analyte is present during the test. For example, the wireless chip 114 may adjust the power supply voltage (1.8V, 3.3V, 5V, etc.) to 150mV and apply 150mV to the electrodes 202a to generate a 150mV voltage to promote and / or improve the chemical reaction of the test zone when the target analyte is present. In this way, more electrons flow from the test zone to the zone corresponding to electrode 202b (e.g., non-test area) compared to the flow without applying an electric potential. The electric potential to improve one or more chemical reactions can correspond to a positive voltage or a negative voltage. The supply of electric potential (e.g., application) can be applied via a working electrode or to an electrode (e.g., corresponding to whether the voltage is positive or negative). Because the wireless chip 114 uses the energy obtained from the antenna 115 via an electromagnetic field, the wireless chip 114 can apply (multiple) electric potentials and / or (multiple) balances without using a battery.

[0085] exist Figure 2DIn the example of , the porous medium 109 itself acts as a salt bridge for the biofuel cell. The biofuel cell uses an additional enzyme (e.g., a reductase such as laccase) at the counter electrode (e.g., cathode). In such an example, the laccase is used as 4e - +4H + The oxygen (O2) is reduced to 2H2O from the reaction at the anode. Figure 2A The bioelectrochemical (e.g., biofuel) cells 111a-d of and / or 2B are impregnated with glucose and a redox species, and generate a voltage and / or current when the target analyte reacts with the redox species of the biofuel cell in combination with glucose as an electron mediator (e.g., after the buffer resuspends the desiccant of the biofuel cell 111a-d). Figure 2D In the example of , no chromatography paper (e.g., the impregnated paper of the above-mentioned biofuel cells 111a-d) is included, and glucose and a redox agent are included in the liquid assay buffer. In this way, when the liquid assay buffer including glucose and a redox agent is applied to the sample pad 106, the liquid assay buffer saturates the porous medium 109. In this way, if the target analyte is present in the sample, the corresponding conjugate / detector labeled with GOx / gold nanoparticles will become solidified in the corresponding test area. Because the porous medium 109 is saturated with glucose and a redox agent after the liquid assay buffer is applied, GOx will react with (e.g., oxidize) the glucose on the test area, while the redox agent acts as an electron mediator to convert [Fe(CN)6] 3- Reduction to [Fe(CN)6] 4- This result corresponds to a measurable voltage drop and / or current between the test area and the non-test area of ​​the porous medium 109, which can be measured by the example wireless chip 114 via the example electrodes 202a-f. Figure 2D An example of this is a bioelectrochemical cell integrated into an LFA.

[0086] As described above, in some embodiments, the bioelectrochemical cells 111a-d can undergo an enzymatic reaction with a natural mediator (e.g., oxygen). In such embodiments, glucose is oxidized to gluconolactone and FADH2 is oxidized to FAD, thereby producing H2O2. Additionally or alternatively, in the presence of glucose oxidase, glucose can oxidize and reduce oxygen to produce C6H 12 O6 reacts with oxygen (O2) to produce C6H 10 O6 and products such as H2O2 (hydrogen peroxide). In such an example, the electrode can be made of a metal (e.g., copper) or a screen-printed carbon electrode doped with ferrocyanide. In this way, the H2O2 is reduced and the metal or ferrocyanide of the electrode is oxidized by releasing electrons. In the latter case, ferrocyanide [Fe(CN)6] 4-With [Fe(CN)6] 3- reaction. The released electrons can be measured by a sensor (e.g., using current and / or voltage measurements) and processed by a processor (e.g., local to the wireless chip 114 and / or reader 116) to determine a test result. Copper surfaces are typically oxidized by air to Cu2O (Cu(I)). Cu2O is oxidized to CuO (Cu(II)) by reduction with H2O2.

[0087] As mentioned above, the intermediate reaction products (such as hydrogen peroxide) are respectively Figure 2D The glucose oxidase on the control and / or test line in the porous membrane 109 is produced. In some examples, glucose from the buffer can react with the glucose oxidase on the LFA (e.g., outside the control line or the test line) to produce a small amount of product (e.g., hydrogen peroxide) on the test line where the glucose oxidase is not mobilized (e.g., when the target analyte is not present in the sample). However, when the target analyte is not present in the sample, the product concentration on this area is too low to generate enough electrons with the electrodes on the target line. Therefore, in such an example, a small amount of product will not produce a false positive test result. After the product is produced, the product (e.g., hydrogen peroxide) is diluted with the surrounding acetate buffer. Therefore, without stopping the flow, the product migrates to the wicking pad 112 and cannot completely or fully react with the electrodes 202a-202f, which may result in no current signal or a reduced current signal. In addition, without stopping the flow, the product (e.g., hydrogen peroxide) produced from the first test line may flow to the second test line or the control line. In this manner, a product corresponding to the first test line (eg, hydrogen peroxide) may be detected on the second test line or control line as opposed to being detected on the first test line, leading to inaccurate results.

[0088] In addition, electrochemical measurements are based on diffusion processes between electrodes 202a-f. With complete flow, convection is an additional factor that affects the current results of biochemical reactions together with diffusion. Therefore, after a product (e.g., hydrogen peroxide) that can react with an electrode to cause an electric current is produced at the control line and / or test line of the porous medium 109, the product (e.g., hydrogen peroxide) is diluted with a surrounding buffer (e.g., acetate buffer). In this way, if the electrode 202a-f contacts the porous medium 109 after the product has flowed to the wicking pad 112, there may not be enough product to react with the metal in the electrode 202a-f to generate an electrical signal (e.g., by releasing electrons). Therefore, the examples disclosed herein can (e.g., in whole or in part) block (e.g., slow down, stop, etc.) flow to prevent and / or slow down product migration away from the test area and / or control area. In some examples, a mechanical device can be used to block flow by cutting (e.g., in whole or in part) the exemplary porous medium 109 at the exemplary film cut 201, thereby stopping the product from flowing to the exemplary wicking pad 112. Additionally or alternatively, flow may be blocked by applying a substance (e.g., glue, gel, chemical, etc.) to the porous membrane 109, activating a substance on the porous membrane 109, squeezing the porous membrane 109, etc. In this manner, the product (e.g., hydrogen peroxide) will remain on the corresponding test and / or control line to react with the metal of the electrodes 202a-f. Figure 2D The example includes two film cutouts 201 (e.g., before the first test line / control line and after the last test line / control line), but film cutouts may exist between different test lines / control lines and / or the film cutout before the first test line / control line may be removed. Figure 2L-2R Examples of one or more mechanical devices that cut the porous media 109 to stop, obstruct, or otherwise block flow are further described.

[0089] Additionally or alternatively, a mechanical device may apply compression on the porous medium 109 to create a barrier (e.g., along the line shown at the membrane cutout 201) that acts as a barrier to block the flow of the product (e.g., hydrogen peroxide) to the wicking pad 112. Additionally or alternatively, a chemical (e.g., glue, gel, oil, etc.) may be added or included on and / or in the porous membrane (e.g., along the line shown at the membrane cutout 201) that acts as a barrier to block the flow of the product to the wicking pad 112. Additionally or alternatively, any mechanism (e.g., mechanical, electrical, chemical, etc.) may be used to block flow to prevent the product (e.g., hydrogen peroxide) from flowing away from the test zone and / or the control zone.

[0090] In addition, as disclosed herein, in alternative embodiments, amperometric redox reactions without enzymes can be used for bioelectrochemical cells 111a-d. For example, the amperometric signal of the LFA device 104 can be measured without the GOx enzyme because the gold of the AuNP can act as a catalyst. In such an example, thiosulfate can be used to improve the signal, as shown in processes 6-8 above. In addition, as shown in process 8 above, thiosulfate, ferrocyanide and KBr or KCl react, and the AuNP will catalyze the reduction of ferrocyanide to produce an electronic signal.

[0091] For example, in Figure 2D In the embodiment, electrode 202c is in contact with the T1 test area, and electrode 202d is in contact with the non-test area (e.g., the porous medium outside the PC area, T1 area, and NC area). In such an example, if the target analyte corresponding to T1 is present in the sample, when the sample is applied to the sample pad 106, the sample will flow into the conjugate pad 108 and bind to the binder and / or detector labeled with GOx, gold nanoparticles, and / or (multiple) other labels, and continue to flow through the porous medium 109 and enter the waste pad 112. Because the target analyte is present in the sample, the target analyte attached to the binder / detector labeled with GOx / gold nanoparticles will be solidified in the test area T1. Therefore, after the porous medium 109 is saturated with the liquid buffer assay (e.g., a threshold time after the liquid buffer assay including glucose and the redox species is applied to the sample pad 106), the GOx / gold nanoparticles at the test zone T1 will oxidize the glucose at the test zone T1 to generate a voltage drop (e.g., a voltage drop) between the test zone T1 and the area next to the test zone where the electrode 202d is located. Figure 2D The example wireless chip 114 measures the voltage drop and / or current from electrode 202c to electrode 202d, and determines the presence of the target analyte when the voltage drop and / or current is above a threshold.

[0092] In operation, when Figure 1A The LFA device 104 is implemented Figure 2GIn the example of the present invention, a user or technician applies a sample (e.g., 25 microliters of urine, blood, etc.) to the example sample pad 106. After applying the sample, the user or technician applies a biofuel-based buffer (e.g., 6 drops of a liquid assay buffer containing glucose and a redox agent) to the sample pad 106 and / or a dedicated buffer pad. Once applied, the user waits for a threshold amount of time (e.g., 15 minutes) required for the fuel cell activation of the porous medium 109. In other examples, the threshold amount of time can be 20 minutes or other values. In some examples, a software / application-based timer or a timer powered by a voltage and / or current generated on the porous medium 109 is used to track the threshold amount of time. After the threshold duration, the user and / or technician uses a reader 116 to interact with the LFA device to obtain diagnostic test results (e.g., by generating an electromagnetic field), and within the duration (e.g., 1 minute), the wireless chip 114 of the LFA device 104 transmits the results to the reader 116 using an antenna 115. In some examples, the duration for reading the diagnostic test results can be other values, such as, for example, less than one minute or more than one minute or more minutes (e.g., 2 minutes, 3 minutes or more). In some examples, the reader 116 instructs the user to take action to stop the flow on the LFA device 104. In such an example, the reader 116 can instruct the user to take action after a second duration (e.g., 5 minutes) after a threshold amount of time (e.g., 15 minutes). In some examples, the reader 116 can instruct the user to scan the LFA device 104 to confirm that the correct LFA device has been selected for shearing before the second duration (e.g., 5 minutes). The amount of time required for the reader 116 to power the wireless chip 114 to measure the electrical signal and transmit the measurement signal can be 1-3 seconds. In some examples, the reader 116 instructs the user to confirm that the action to stop the flow has been taken. Thereafter, the reader 116 starts a countdown of the duration (e.g., 1 minute) for the clock, timer, and / or diagnostic test to be read. In some examples, the reader 116 provides a presentation indicating the time and duration disclosed herein on the user interface 120.

[0093] Figure 2E Shows Figure 2D A side view of a porous medium 109 of a machine-readable lateral flow immunoassay. Figure 2E In some examples, the layer with electrodes 202a-f is in direct contact with the porous medium 109. In some examples, the electrodes are incorporated into the non-conductive layer, and the non-conductive layer including electrodes 202a-f is placed (e.g., during manufacturing) in contact with the porous medium so that the electrodes 202a-f are as shown in FIG. Figure 2D In some examples, electrodes 202a-f are each placed (e.g., during manufacturing) in contact with porous medium 109 to Figure 2DIn some examples, electrodes 202a-f are not in contact with porous membrane 109 until the device is ready to be read, as in the following combination Figure 2L-2R Further described.

[0094] Figure 2F An exemplary conjugate is shown that can be attached to a Figure 2A-2E Immobilized antigens, analytes and / or antibodies on a test zone on a porous medium 109 of a machine-readable lateral flow immunoassay. Figure 2F An example implementation 204 is shown. Figure 2F Also included are HIV-1 target analyte 206, recombinant HIV-1 capture antigen 208, HIV-2 capture antigen 210, HIV-1 antibody, HIV-1 antigen and glucose oxidase complex 211, recombinant immobilized HIV-1 antigen 212, recombinant immobilized HIV-2 antigen 214 and antiserum 216.

[0095] During testing, the user and / or patient applies a patient biological sample and / or a buffer solution via the sample pad 106. Figure 2F In the example of FIG. 2 , the sample includes an example HIV-1 target analyte 206. The biological sample and / or buffer flow to Figure 1A and 1B The exemplary conjugate pad 108 is pre-treated with exemplary recombinant HIV-1 capture antigens 208 (e.g., gp41 and p24) and exemplary HIV-2 capture antigens 210 (e.g., gp 36) that are linked to (e.g., attached to, labeled with, etc.) glucose oxidase. Because the biological sample includes Figure 2F The exemplary target analyte 206 in the test line 1 is attached to the exemplary HIV-1 capture antigen 208 and glucose (e.g., corresponding to the formation of the exemplary HIV-1 antibody, HIV-1 antigen and glucose oxidase complex 211), which is transported to the wicking pad 112. Test line 1 is coated with exemplary recombinant immobilized HIV-1 antigens 212 (e.g., gp41 and p24), and test line 2 is coated with exemplary recombinant immobilized HIV-2 antigens 214 (e.g., gp36). In the case of a positive patient sample with HIV-1 antibodies 206, the antibody-antigen-glucose oxidase complex 211 binds to the immobilized recombinant HIV-1 antigen 212 on test line 1. However, because the biological sample does not include the HIV-2 target analyte, it is not bound to test line 2. As described above, when the enzyme reacts with the buffer (e.g., glucose), the antigen-antibody complex 211 linked to the enzyme (e.g., glucose oxidase) produces a product (e.g., hydrogen peroxide) on test line 1. Figure 2FThe control line includes exemplary antiserum 216 (eg, sheep anti-recHIV antiserum) that binds exemplary recombinant HIV-1 antigen 208 .

[0096] Figure 2G The example housing 222 is shown in FIG. Figure 2D-2E Example lateral flow immunoassay. Example housing 222 houses Figures 1A-2C The example sample pad 106, the example conjugate pad 108, the example porous medium 109, the example waste pad 112, the example wireless chip 114 and the example antenna 115. The example housing 222 also contains Figure 2D-2E The example housing 222 includes example openings 223 , 225 and example layers 224 , 226 , 228 .

[0097] Figure 2G The top layer 224 of the example housing 222 includes example openings 223, 225 to allow a user and / or technician to apply a sample and / or a liquid buffer. In some examples, the sample will be supplied through opening 225, while the liquid buffer is supplied in opening 223, which is located closer to the edge of the housing 222. This allows the buffer to wash the sample from behind, as Figure 2G The direction of lateral flow in the tester shown is from left to right. Alternatively, the housing 222 may include an opening for both the sample and the liquid buffer. In some examples, the openings 223, 225 include a cap to prevent evaporation (e.g., evaporation of the sample and / or the liquid buffer). Additionally or alternatively, the housing 222 may include a physical structure (e.g., a foam pad) located at the top layer and / or the lower side of the middle layer 224, 226 to apply uniform pressure (e.g., via the interaction of the user with the housing 222) to the porous medium 109. In this way, the sample and / or the liquid buffer are evenly diffused throughout the porous medium 109. The second / middle layer 226 includes a wireless chip 114, an antenna 115, and electrodes 202a-f. In some examples, the bottom of the top layer 224 includes a pad to push the electrode to contact the porous medium 109 to obtain a more complete connection between the sections of the electrode 202a-f and the porous medium 109.

[0098] In some examples, the middle layer 226 may further include additional electrodes for risk mitigation for reading the LFA in the bottom layer 228 too early and / or too late. For example, the exemplary middle layer 226 may include an electrode in contact with the waste pad 112 (e.g., an anode) and / or an electrode in the waste pad in contact with the waste pad 112 (e.g., a cathode). The waste pad 122 may be impregnated with ascorbic acid, which, when saturated when performing a test, reacts with molecules in the waste pad 122 to generate a voltage, current, and / or an electromotive force (e.g., due to the different pH levels that the electrodes contact). In this manner, the wireless chip 114 may read the voltage and / or current difference between the electrodes in the waste pad 112 to determine whether the LFA-based test is ready and / or whether the user has waited too long to receive an accurate result. For example, the anode electrode will not measure the voltage, current, and / or electromotive force until the test is ready to be read because the dried citric acid has not yet been resuspended by the buffer, indicating that the test is not ready to be read. When the test is ready to be read, the anode electrode measures voltage, current and / or electromotive force because the dried citric acid has been resuspended by the buffer, which indicates that the test is ready to be read. In addition, when the test is read too late, the resuspended citric acid diffuses into the cathode area, which causes a cancellation of the electromotive force, indicating that the test time has expired and there is no longer a stable flow through the device to output an accurate result. (e.g., the test can no longer be read). The bottom layer 228 of the housing 222 includes LFA material.

[0099] Figure 2H Shows Figure 1A An alternative embodiment of a machine-readable lateral flow immunoassay 104 is provided. Figure 2H As shown, the machine-readable lateral flow immunoassay 104 includes the porous medium 109 of FIG. 1 and the example quantum dots 230 located on the example working electrode 232. The example lateral flow immunoassay 104 also includes an example working electrode 232, an example counter electrode 234, and an example reference electrode 236. The example electrodes 232, 234, 236 can be silver carbon electrodes, copper electrodes, graphite carbon electrodes, titanium electrodes, brass electrodes, platinum and palladium electrodes, screen-printed carbon electrodes doped with ferrocyanide, and / or any other type of electrode or electrode combination. Figure 2H The machine-readable lateral flow immunoassay 104 may be used in conjunction with the bioelectrochemical cell described above.

[0100] Figure 2HThe example quantum dots 230 are operated as conjugates on the example LFA 104. There may be different quantum dots (e.g., zinc sulfide, lead sulfide, magnesium sulfide, copper sulfide, cadmium sulfide, etc.) corresponding to process controls, negative controls, and / or one or more target analytes. During manufacturing, the example machine-readable LFA generator 102 can dissolve the quantum dots 230 in a weak acid or suitable solvent and generate dissolved quantum dots that are added to the conjugate pad of the LFA 104. In this way, when a sample is applied to the LFA 104, the target analyte corresponding to the specific quantum dot is attached to the quantum dot. When the quantum dots attached to the target analyte flow to the test area of ​​the porous medium, the quantum dots are immobilized by the antigens, analytes and / or antibodies of the test area corresponding to the one or more target analytes.

[0101] The example working electrode 232 of FIG. 2 is in contact with the porous medium of the LFA 104. Thus, the working electrode 232 is in contact with the test area and any solidified quantum dots (e.g., when the target analyte is present). In order to determine whether the target analyte is present, the wireless chip 114 or another device can perform a stripping voltammetry process. In order to establish a stripping voltammetry process, the wireless chip 114 or other voltage source applies a voltage to the working electrode 232 for a specific amount of time (e.g., 60-180 seconds) to deposit (e.g., coat) the solidified quantum dots onto the working electrode 232. After the quantum dots are deposited onto the working electrode 232, the wireless chip 114 can perform a stripping voltammetry process for a duration (e.g., 60-240 seconds). Stripping voltammetry involves changing the potential between the counter electrode 234 and the reference electrode 236, which results in a change in current and / or voltage if the quantum dots are deposited on the working electrode 232. When the change in current and / or voltage is measured to exceed a threshold amount, the wireless chip 114 determines that the target analyte is present.

[0102] Figures 2I-2K Shown in Figure 1A , 1B , 2A and / or 2B and the example bioelectrochemical cells 111a-d Figure 1A , 2A The example front-end channels 240, 250, 260 for interfacing between the wireless chips 114 of the 2B and / or 2B. Additionally or alternatively, the example front-ends 240, 250, 260 may be Figure 2D , 2EThe example front ends 240, 250, 260 may be implemented as components external to the wireless chip 114, and / or interfaced between the electrodes 202a-f, 234, 236 of the 2H and the wireless chip 114. Although the example front ends 240, 250, 260 may be implemented as components external to the wireless chip 114, the front ends 240, 250, 260 may be implemented in the wireless chip 114 and / or as part of another device. If the example wireless chip 114 is implemented in a separate device (e.g., separate from the LFA 104), the example front ends 240, 250, 260 may be implemented in the LFA 104 and / or in a device including the wireless chip 114.

[0103] Fig.2I The example front end channel 240 acts as an electronic multiplexer, a set of MOSFETs, and / or any other electronic circuit to transmit the signals received from each bioelectrochemical cell 111a-d to the four inputs of the wireless chip 114. The example wireless chip 114 outputs control signals to the example front end 240 to control which bioelectrochemical cell signal is processed at different points in time. Fig.2I The wireless chip 114 includes four inputs (e.g., very high, high, low, and very low), but the wireless chip 114 may include any number of inputs corresponding to any number of levels. The four inputs of the wireless chip 114 compare the amplitude of the obtained signal with a preset threshold to identify the amount of voltage or current measured. For example, if the output of the bioelectrochemical battery 111a-d is a voltage (e.g., for a potentiometer sensor), the first input may compare the amplitude of the obtained voltage with 80mV, the second input may compare the amplitude of the obtained voltage with 60mV, the third input may compare the amplitude of the obtained voltage with 40mV, and the fourth input may compare the amplitude of the obtained voltage with 20mV. In this way, if the front end 240 outputs a 70mV signal from the first bioelectrochemical battery 111a, the wireless chip 114 will determine based on the comparison that the obtained signal is high (e.g., higher than 60mV) but not very high (e.g., higher than 80mV). The wireless chip 114 may transmit the determined output strength (e.g., very high, high, low, or very low) for each measurement to the exemplary LFA reader application 117. In this manner, the results may be further analyzed to identify patterns, to determine the accuracy of the test, and / or for device monitoring purposes (e.g., at the reader 116 and / or at another external device, database, server, or data center).

[0104] Figure 2JThe example front-end channel 250 is an alternative embodiment that acts as a multiplexer and / or demultiplexer to transmit signals received (e.g., accessed, obtained, etc.) from each bioelectrochemical cell 111a-d to a corresponding input of the wireless chip 114. For example, the front-end channel 250 ensures that the output of the first bioelectrochemical cell 111a is transmitted to the first input, the output of the second bioelectrochemical cell 111b is transmitted to the second input, and so on. For example, the front-end channel 250 can be implemented with a multiplexer and a demultiplexer, wherein the select lines of the multiplexer and the demultiplexer are coupled together to ensure that the first output of the bioelectrochemical cell 111a is transmitted to the first input of the wireless chip 114, the second output of the bioelectrochemical cell 111b is transmitted to the second input of the wireless chip 114, and so on. The example wireless chip 114 outputs one or more control signals to the example front-end 240 to control which bioelectrochemical cell signal is processed at different points in time. In some examples, the front end channel 250 may include a multiplexer that is controlled to sample / measure corresponding ones of the electrodes at different points in time, and each measurement is passed to a single comparator or analog-to-digital converter of the wireless chip 114. In this way, all results can be obtained using a single component on the wireless chip 114. In some examples, the front end 250 is controlled to obtain multiple measurements of each test line and multiple measurements of each control line. For example, the front end 250 is controlled to obtain multiple measurements of the test line control line, where the wireless chip 114 transmits the multiple results to the reader 116 and / or performs statistical pre-processing on the multiple measurements before sending the data to the reader 116. Although Figure 2J The wireless chip 114 includes four inputs (e.g., for four bio-electrochemical cells 111a-111d), but the wireless chip 114 may include any number of inputs corresponding to any number of cells, controllers, and / or electrodes. Figure 2J In the example of , the input of the wireless chip 114 determines the amount (eg, as a digital value) corresponding to the current and / or voltage of the first bio-electrochemical cells 111a - 111d . The wireless chip 114 can transmit the determined output strength for each measurement to the example LFA reader application 117 .

[0105] Figure 2K The example front-end channel 260 is an alternative embodiment corresponding to a direct channel between each bioelectrochemical cell 111a-d to the corresponding input of the wireless chip 114. For example, the first output of the bioelectrochemical cell 111a is directly coupled to the first input of the wireless chip 114 via the first channel, the second output of the bioelectrochemical cell 111b is directly coupled to the second input of the wireless chip 114 via the second channel, and so on. Figure 2KThe wireless chip 114 includes four inputs (e.g., for four bio-electrochemical cells 111a-111d), but the wireless chip 114 may include any number of inputs corresponding to any number of cells, controllers, and / or electrodes. Figure 2K In the example of , the input of the wireless chip 114 determines the amount (eg, as a digital value) corresponding to the current and / or voltage of the first bio-electrochemical cells 111a - 111d . The wireless chip 114 can transmit the determined output strength for each measurement to the example LFA reader application 117 .

[0106] although Fig.2I , 2J The exemplary wireless chip 114 of 2K includes a comparator for comparing the magnitude of the obtained voltage and / or current with a threshold value and transmitting a result corresponding to the comparison, but the exemplary wireless chip 114 may include an analog-to-digital converter for converting the analog voltage and / or current reading into a digital value and transmitting the digital value to the exemplary reader 116. In this way, the exemplary reader 116 can compare the digital value with one or more thresholds to determine the result. In some examples, the wireless chip 114 can obtain multiple voltage and / or current measurements (e.g., voltage samples, current samples, etc.) for each test line and control line, convert the measurements into digital values, and transmit all digital values ​​to the exemplary reader 116. In some examples, the wireless chip 114 can pre-process the values ​​(e.g., statistical analysis, such as determining the mean, median, mode, standard deviation, etc. of multiple measurements) and transmit one or more values ​​representing the multiple measurements to the reader 116.

[0107] Figure 2L-2O An example of preventing (e.g., stopping and / or slowing) the flow of liquid (e.g., including generated products, such as hydrogen peroxide) to a wicking pad or a waste pad is shown. As described herein, flow can be prevented to allow a certain amount of generated products (e.g., hydrogen peroxide) to accumulate or otherwise be present at the test line, thereby reacting with electrodes contacting the test line to generate a measurable electrical signal. In some examples, the electrodes can be moved into contact with the test line to react after the flow has been prevented. In some examples, the electrodes are moved into contact with the test line when the flow organization is deployed or activated. Figure 2L-2O Including the LFA device 104 is in a flow position (e.g., Figure 2L and 2N ) and read positions (e.g. Figure 2M and 2O ) section. At the flow location of the LFA device 104, chemical mixing and reactions as disclosed herein occur, and the elements and / or products flow along, for example Figure 1A The porous medium 109 flows. At the reading position, Figure 2DElectrodes 202a-f are applied to the porous medium 109 to begin the read phase of the diagnostic test. Figure 2L An example of -O includes an example switch 278 , one or more example flow resistors 280 , and an example electrode plate or chip 282 .

[0108] Figure 2L -O example switch 278 is in a first position (e.g., Figure 2L and Figure 2N flow position shown) and a second position (e.g., Figure 2M and Fig.2O In some examples, the switch 278 slides within a groove or track 279 in the housing 222 of the LFA device 104. In some examples, the switch 278 slides, translates, or otherwise moves within the LFA device 104 between the first position and the second position. For example, the switch 278 can be pressed downward to contact the porous medium 109.

[0109] The switch 278 includes an exemplary positionable flow resistor 280 that is positionable to slice, cut, shear, and / or compress the exemplary porous medium 109 (e.g., corresponding to the example porous medium 109) when the switch 278 is moved from a first position to a second position. Figure 2D 201 ). In some examples, the flow blocker 280 includes one or more blades to cut (e.g., partially or completely) the porous medium 109. In some examples, to partially cut the porous medium 109, the blade partially cuts into the depth of the porous medium. In some examples, a portion (e.g., a lower portion) of the depth of the porous medium 109 remains uncut. In some examples, the flow blocker 280 includes one or more ridges to press into the porous medium 109. In some examples, flow is blocked by applying a chemical (e.g., glue, gel, oil, etc.) to the porous medium 109 at one or more locations where the flow blocker 280 contacts the porous medium 109. In some examples, the chemical can be configured to release for a duration after a liquid sample or buffer has been applied (e.g., when the chemical is wetted by the liquid sample or buffer), the duration corresponding to the time that flow should be blocked to prevent the product (e.g., hydrogen peroxide) from flowing out of the test and / or control zone.

[0110] In the illustrated example, there are two flow resistors 280. In some examples, there are other numbers of flow resistors 280, such as, for example, one, three, etc. In some examples, when there is one flow resistor, the flow resistor is positioned to compress, cut, or shear the porous medium 109 between where the electrode(s) 202a-202f contact the porous medium 109 and the wicking pad 112 to isolate the wicking pad 112 and prevent the product (e.g., hydrogen peroxide) from further wicking through the porous medium 109. In some examples, a second flow resistor 280 may be used to prevent liquid from flowing back to the conjugate pad 108.

[0111] The switch 278 is initially placed in a first position (e.g., away from the porous medium 109). As described herein, when a sample is applied to the LFA device 104, the sample flows through the porous medium 109. If the target analyte is present in the sample, a chemical reaction occurs, resulting in the release of a product (e.g., hydrogen peroxide) in the target area. For a duration after the sample is applied, the reader 116 can instruct (e.g., command, prompt, etc.) the user to move the switch 278 from the first position to the second position (e.g., above the porous medium 109), thereby causing the exemplary flow blocker 280 to cut, shear and / or compress (e.g., squeeze) the porous medium 109 to stop or reduce the flow of a mixture that includes any mobilized products (e.g., hydrogen peroxide) that correspond to electron flow when present. In some examples, the switch 278 can release a substance (e.g., oil, glue, gel, etc.) along a line corresponding to the membrane cutout 201 on the porous membrane 109 to act as a barrier to stop the flow of products (e.g., hydrogen peroxide) that cause the current. In some examples, the substance can be configured to release for a duration after a liquid sample or buffer has been applied (e.g., when the liquid sample or buffer wets the substance), which duration corresponds to the time that flow should be blocked to prevent the product (e.g., hydrogen peroxide) from flowing out of the test and / or control area. The product is retained in the region of the porous medium 109 between the flow blockers 280. In this way, the product (e.g., hydrogen peroxide) can react with the metal of the (multiple) electrodes 202a-202f present in this region of the porous medium 109. The reaction of the product with the electrodes 202a-202f generates an electrical signal (e.g., by releasing electrons), which can be read by the example wireless chip 114 to determine the presence of a target analyte in the sample. In some examples, if the electrode is in contact with the porous membrane 109 when the product (e.g., hydrogen peroxide) is generated, the electron flow may be low and / or inconsistent, which may correspond to a false negative or false positive test result. Therefore, after the duration of allowing the product (e.g., hydrogen peroxide) to be generated, the electrode can be placed in place (e.g., in contact with the porous membrane 109). For example, because switch 278 makes example electrodes 202a-202f contact after glucose oxidase and glucose have enough time to react to generate product hydrogen peroxide, after flow has stopped, the amount of product will be enough to react with (multiple) electrodes 202a-202f to generate a strong enough electrical signal to measure without the need for an external power source. In other words, in some examples, no external power source is needed to provide an electric potential to facilitate reading the electric signal of the reaction from the electrode, because allowing the electrode to contact the porous membrane 109 at the appropriate time will generate a strong enough signal without the need for an external power source. In some examples, an electric potential can be applied to the electrode to facilitate the chemical reaction to provide a strong enough signal. When testing glucose and glucose oxidase reactions, contacting the electrode with the porous membrane 104 will produce a smaller electrical signal, which is more difficult to sense.In some examples, the switch 278 can be configured to lock into two preset positions (e.g., a flow position and a read position). In this manner, a user is less likely to accidentally move the switch 278 and / or more likely to perform a sheer when instructed by the reader 116. For example, the switch 278 can include a mechanism to hold the switch in the flow position and / or the read position until a threshold amount of force is applied, or until the switch 278 is adjusted out of the locked position. In some examples, a click sound is emitted when the switch 278 is moved out of the flow position and / or when the switch 278 is moved to the read position to provide an audio indication to the user that the switch 278 has moved a position and / or that the switch movement is complete.

[0112] Figure 2L An example electrode plate 282 is comprised of Figure 2D 202a-202f of the switch assembly 278. In the first position of the switch 278, the electrode plate 282 is positioned at an angle relative to the porous medium 109 and / or the switch 278. The LFA device 1045 includes an example LFA support 283 in the housing 222. The support 283 includes an angled slot 284 to accommodate the electrode plate 282 at an angle relative to the horizontal plane of the porous medium 109 when the LFA device is in the flow position. In this manner, the electrodes 202a-f on the example electrode plate 282 do not contact the porous medium 109. When the user moves the switch 278 to the second position, the angle of the electrode plate 282 changes due to the movement of the switch assembly 278 and the ridge or fulcrum 286 of the LFA support 283. For example, the movement of the switch 278 pushes the electrode plate 282 and rotates the electrode plate 282 toward the porous medium 109 about the fulcrum 286 until the electrode plate 282 contacts the porous medium 109 (e.g., in the second position or reading position). In the second position, the electrode plate 282 is parallel to and / or contacts the porous medium 109 and / or the switch 278. In this way, the electrode 202a-202f is present in the region of the porous medium 109 between the flow blockers 280, and can react with a product that can react with the electrode to generate electrons, and the wireless chip 114 can measure the current and / or voltage difference corresponding to the electrons to determine whether there is a target analyte in the sample. If the electrode plate 282 does not contact the porous membrane 109 when the reader 116 attempts to read the result, there will be no indication from the electrode corresponding to the control zone or line. Therefore, if the user fails to move the switch 278 to the reading position, the electrode 202a-202f will not contact the porous membrane 109, and if the reader 116 attempts to read the result, an error will be output to the user. In some examples, the electrode plate 282 is pivotable. In such an example, a user may move and / or pivot the switch, which causes the example electrode plate 282 to pivot into position (eg, into contact with the porous membrane) while preventing flow over the porous membrane 109 (eg, using the example flow preventer 280 ).

[0113] In some examples, instead of or in addition to the example flow resistor 280 implemented on the example switch 278, one or more flow resistors 280 can be implemented in the electrode plate 282. In this manner, as the electrode plate 282 moves toward the porous medium 109, the flow resistor 280 of the electrode plate 282 can compress, cut, and / or shear the porous medium 109 to stop or reduce the flow of the mixture toward the wicking pad 112. In the second position, the example switch 278 holds the electrode plate 282 in place to ensure that the electrodes 202a-202f remain in contact with the porous medium 109. In some examples, ridges or fulcrums 286 help secure the electrode plate 282 in the first or second position.

[0114] In some examples, the electrode plate 282 is integrated with the switch 278. For example, the surface of the switch 278 opposite the porous medium 109 in the second or reading position can include the electrode plate 282, so that when the switch 278 is moved to the second position, the electrodes 202a-202f are pressed into and / or otherwise contact the porous medium 109. In some examples, the electrode plate 282 can be positioned on the switch laterally offset from the flow resistor 280, so that the flow resistor 280 contacts the porous medium 109 to prevent flow before the electrode plate 282 contacts the porous medium 109. In other examples, the electrode plate 282 and the flow resistor 280 are aligned on the switch 278.

[0115] Although the example switch 278 compresses, cuts and / or shears the porous medium 109 and the electrode plate 282 in contact with the porous medium 109 in response to a sliding motion from a user, the example switch 278 can be configured to compress, cut and / or shear the porous medium 109 and / or move the electrode plate 282 in contact with the porous medium 109 in other ways, including, for example, automatically, via a pushing motion and / or any other user and / or processor control.

[0116] Figure 2P A perspective view of the LFA device 104 with an alternative example switch 292 is shown. Figure 2Q is along Figure 2P A partial cross-sectional view of the LFA device taken along line QQ. Figure 2Q In, with Figure 2P In comparison, the LFA device 104 has been rotated 180 degrees, with a portion of the top plate shown in phantom, and another portion removed at line QQ, which shows the interior of the LFA device 104 . Figure 2R is along Figure 2P A partial cross-sectional view of the LFA device taken along line RR. The LFA device 104 is Figure 2R The orientation in is similar to Figure 2QThe switch 292 includes an example handle or actuator 293. The actuator 293 enables a user to move the switch 292 between a first position (e.g., a flow position) and a second position (e.g., a reading position). The example switch 292 also includes a flow resistor 280 as described above. In the illustrated example, the flow resistor 280 is coupled to or positioned on a side of the switch 292 opposite the actuator 293.

[0117] Figure 2Q An example switch 292 is shown in a first position (e.g., flow position) in which the flow blocker 280 is positioned away from the porous medium 109. In this position, the example electrode 202a is not in contact with the test line of the porous medium 109. When the test is ready to be read, the user pushes, translates, slides, or otherwise moves the actuator 293, which moves the switch 292 to the reading position (e.g., above the porous medium 109). In this position, the flow blocker 280 compresses, cuts, and / or shears the porous medium 109 to reduce or stop the flow along the porous medium 109. In this way, any product (e.g., hydrogen peroxide) generated along the porous medium 109 in the region between the flow blocker 280 contacting the porous medium 109 is retained in the region and near or at the corresponding test and / or control line. In addition, moving the switch 292 causes the electrode 202a to contact the test line of the porous medium 109. In this manner, the product (e.g., hydrogen peroxide) at the test line can react with electrode 202a to cause a measurable release of electrons corresponding to a positive test result. Figure 2P In the example of FIG. 2-R, a user moves actuator 293 in a sliding motion to operate switch 292 and flow blocker 280. In other examples, other actuations may be used, including automatic motion, pushing, squeezing, and / or any other user and / or processor control.

[0118] In some examples, Figure 2G , 2L-2R LFA device 104 and / or housing 222 may include a compartment for a holding device (e.g., a bag) containing a holding liquid (e.g., a second liquid buffer). The holding device may be located near the porous medium 109. In such an example, a mechanical device (e.g., switch 278, one or more flow blockers 280, electrode plate 282, switch 292, and / or another device) may be used to destroy the holding device, and / or otherwise cause the holding device to release the liquid contained in the holding device. In this way, the liquid can re-buffer the porous medium 109 to change the buffering conditions to optimal and / or improved conditions for antigen coupling, thereby providing a more reliable and / or effective electronic readout. The fluid stored in the holding device (e.g., a second liquid buffer different from the liquid buffer applied to the sample pad of the LFA) may be different from the liquid buffer applied after the sample is applied. For example, the second liquid buffer stored in the holding device includes antibodies and / or antigens that help promote glucose and glucose oxidase reactions to optimize and / or improve electrochemical readout (e.g., current and / or voltage output when the target analyte is present). Additionally or alternatively, the LFA reader 116 may instruct (eg, command, prompt, etc.) a user to add additional buffers to the LFA device to increase the reliability and / or effectiveness of the electronic readout.

[0119] Figure 3A An alternative exemplary machine-readable LFA device 300 is shown, which may be generated by the exemplary LFA generator 102 and / or read by the exemplary machine-readable LFA reader application 117 of the reader 116. The exemplary LFA device 300 implements a circuit completion technique for determining a test result based on an electrical signal. The exemplary machine-readable LFA device 300 is a circuit that includes Figure 1A The circuitry of the exemplary sample pad 106, the exemplary conjugate pad 108, the exemplary porous medium 109, the exemplary test area 110, the exemplary wicking pad 112, the exemplary wireless chip 114 and the exemplary antenna 115 completes the LFA. The exemplary machine-readable LFA device 300 also includes exemplary test / control lines 302, 304, 306, a first exemplary electrode 308a and a second exemplary electrode 308b.

[0120] exist Figure 3A In the exemplary machine-readable LFA device 300 of FIG. 1 , the exemplary conjugate pad 108 includes a conjugate and / or detector (e.g., an antigen and / or an antibody) labeled with gold nanoparticles. The conjugate and / or detector corresponds to a target analyte corresponding to one or more conditions or diseases. In this manner, when a sample is applied to the sample pad 106, if the sample includes a target analyte, the corresponding conjugate labeled with gold binds to the target analyte and flows to the wicking pad 112.

[0121] Figure 3AThe (multiple) test zones and / or (multiple) control zones 302, 304, 306 of the porous medium 109 extend from one side of the porous medium 109 to the other side of the porous medium 109. The (multiple) test zones and / or (multiple) control zones 302, 304, 306 include immobilized antigens and / or antibodies corresponding to one or more target analytes. In this way, if the target analyte is present in the sample, the target analyte (bound to the conjugate labeled with gold) binds to the corresponding test and / or control lines 302, 304. Once the sample has been applied, the user applies a wash solution containing an autocatalytic silver component (e.g., a solution containing silver ions and a reducing agent such as hydroquinone, aminophenol, ascorbic acid) to the sample pad 106 or another sample pad. In some examples, the sample pad 106 (or another pad or inlet) may include silver nitrate and the reducing agent may be in a separate paper / membrane that may be attached to the LFA medium after development (e.g., via a mechanical structure that separates the two membranes but is capable of attaching the two membranes with user intervention (e.g., a user and / or automated structure applies force to the mechanical structure to press the two membranes into contact)).

[0122] When the washing liquid flows to Figure 3A When the silver is applied to the wicking pad 112 of the test and / or control line 302, 304, the silver combines with the solidified gold, thereby expanding the size of the solidified metal at the test and / or control line 302, 304. If the silver is fully expanded, the silver molecules attached to each solidified gold nanoparticle will contact, creating a short circuit (e.g., like closing an electrical switch and acting as a resistive element, such as a resistor). In this way, a voltage can be applied to the example electrode 308a at one end of the test and / or control line 302, 304, 306, and then if the target analyte is present, the silver amplification creates a short circuit with a certain resistance to the second electrode 308b at the other end of the test and / or control line 302, 304, 306, thereby allowing current to flow from electrode 308a to electrode 308b through the silver-amplified gold nanoparticles, which act as a conductive enhancer (e.g., a smaller resistor). The example wireless chip 114 measures current, voltage, electromotive force, and / or resistance to determine whether the target analyte is present (e.g., whether a current greater than a threshold current or a resistance less than a threshold resistance is sensed between electrodes 308a, 308b). The example wireless chip 114 can test each line 302, 304, 306 in series or in parallel. Figure 3B Further disclosed is an exemplary description of a silver amplification process.

[0123] Figure 3B shows the bond attached to Figure 3A The target analyte of the exemplary test line 302 is Figure 3A An exemplary circuit completion process of an exemplary machine-readable LFA device 300 is shown. Figure 3A Examples include Figure 3A1. The exemplary porous medium 109, the exemplary test line 302, and the exemplary electrodes 308a, 308b. Figure 3B The example also includes an exemplary immobilized antibody / antigen 310, an exemplary gold nanoparticle 312, an exemplary conjugate antibody / antigen 314, an exemplary target analyte 316, and an exemplary amplified silver 318. Alternatively, the Figure 3A Any one of lines 302, 304, 306 of 3B is used to describe the example of 3B.

[0124] In stage 1, the example immobilized antibody 310 of the example test line 302 has been attached to the example target analyte 316. Figure 3B As shown, the target analyte 316 is attached to the exemplary conjugate antibody and / or antigen 314 marked with gold nanoparticles 312. However, the gold nanoparticles 312 are too small to contact each other. Therefore, if a voltage is applied to one of the electrodes 308a, 308b, no current flows (e.g., acting as a disconnected switch). Therefore, a wash solution with a silver ion solution is applied to the porous medium 109. As shown in stage 2, the silver in the wash solution is amplified at the gold nanoparticles 312 (e.g., accumulated by an autocatalytic reaction). When a sufficient amount of silver has been amplified (e.g., by reducing silver using a reducing agent (e.g., an autocatalytic reaction)), a short circuit is generated from electrode 308a to electrode 308b (e.g., acting as a closed switch with some resistance). In this way, when the wireless chip 114 applies a positive voltage to electrode 308b, current flows to the example electrode 308a (e.g., via contact silver). The example wireless chip 114 senses the current to determine the presence of the target analyte 316 in the sample.

[0125] Figure 4 yes Figure 1A 4. Block diagram of an example implementation of a machine-readable LFA generator 102 of FIG. The example machine-readable LFA generator 102 includes an example user interface 400, an example component generator 402, and an example component applier 404.

[0126] Figure 4 The example user interface 400 interfaces with a user and / or manufacturer to obtain instructions on how to construct a machine-readable LFA device 104, 300. For example, the user interface 400 may receive (e.g., access, obtain, etc.) instructions on what type of machine-readable LFA device to generate, how many test regions (e.g., for reusing LFA designs) and / or test types to perform by the LFA device 104, 300, and / or how many control regions and / or types to include in the LFA device 104, 300.

[0127] Figure 4The exemplary component generator 402 generates and / or obtains components of the exemplary LFA device 104, 300. For example, the component generator 402 can generate and / or obtain from a storage device a sample pad 106, a conjugate pad 108, a porous medium 109, antibodies, antigens and / or molecules applied to the LFA device 104, 300, a wicking pad 112, a wireless chip 114, an antenna 115, a connection, a housing and / or a bioelectrochemical cell 111a-n. To generate a bioelectrochemical cell, the exemplary component generator 403 can be impregnated with an enzyme substrate (e.g., glucose) and / or a reducing agent (e.g., hydroquinone, aminophenol, ascorbic acid (e.g., vitamin C), etc.) and / or an electron mediator or redox substance (e.g., potassium ferrocyanide, ferrocene, oxygen, a ferrocene derivative, etc.) onto a piece of paper or other substrate and allow the paper to dry, such as, for example, by air drying.

[0128] Figure 4 The exemplary component applicator 404 applies the obtained and / or generated components based on user and / or manufacturing instructions to generate Figure 1A , 1B , 2A, 2B, 2D, 2E, 2H, 2L-2R and / or 3A of an exemplary machine-readable LFA device 104, 300. For example, the component applicator 404 can apply antigens and / or antibodies attached to GOx, silver nitrate, a reducing agent and / or gold to the obtained and / or generated binding pad 108. For the gold nanoparticle amplification method, silver nitrate can be added to a second pad with glucose (e.g., a fuel and / or an enzyme substrate), or the reducing agent can be impregnated in the cell paper / culture medium. In addition, the component applicator 404 constructs the components of the machine-readable LFA device 104, 300, and applies antigens and / or antibodies corresponding to the test quantity, test type, control quantity and / or control type to the test and / or control areas of the test area 110 on the porous medium 109.

[0129] Figure 5 yes Figure 1A , 2A , 2B, 2G, 2I-2K and / or 3A. The example wireless chip 114 includes an example antenna interface 500, an example driver / voltage regulator 502, an example sensor 504, an example comparator 506, an example result storage device 508, an example timer 510 and an example analog-to-digital converter 512.

[0130] Figure 5The example antenna interface 500 is docked with the example antenna 115. For example, when the magnetic field is within a threshold range of the antenna 115, the antenna 115 generates a current from the magnetic field, which is used to power the example wireless chip 114. Therefore, in some examples, the LFA device 104 does not include a battery unit (e.g., a battery that stores energy) and / or does not use an external supply of one or more reactants to generate a voltage. Therefore, the example LFA device 104 is battery-free. For example, the LFA can be powered by an electromagnetic signal obtained at the antenna 115 (e.g., a voltage (e.g., 1.8V, 3.3V, 5V, etc.) based on an electromagnetic signal caused by an external device or reader) or one or more of the bioelectrochemical cells 111a-d (e.g., which generates a voltage based on a chemical reaction caused by oxidation caused by a target analyte attached to an antigen or antibody labeled with GOx and / or gold nanoparticles in a test area). In some examples, a voltage corresponding to the power and / or energy obtained for powering the wireless chip 114 is used to generate an electric potential, which The potential includes, for example, an equilibrium potential that facilitates one or more chemical reactions on the porous membrane 109. In this way, the wireless chip 114 can operate completely without the need for a battery unit such as a battery. In some examples, the wireless chip 114 may include a battery to power the wireless chip 114. In addition, once the result (e.g., one or more test and / or control flags or logical values) is obtained, the antenna interface 500 can be docked with the antenna 115 to transmit the result (e.g., flag) and / or any identification information (e.g., LFA identifier) ​​to the exemplary reader 116.

[0131] Figure 5 An example driver / voltage regulator 502 is to Figure 3AThe voltage driver of the electrode 308a output voltage of the wireless chip 114. As described above, the wireless chip 114 outputs a voltage to determine whether the test area has generated a short circuit representing a positive result of the test analyte due to the completion of the circuit (e.g., silver amplification). Therefore, the example driver / voltage regulator 502 outputs a voltage to the top electrode 308a (e.g., in series or in parallel) to see whether the sensor 504 can measure the current and / or can measure the small resistance at the corresponding bottom electrode 308b, thereby corresponding to a short circuit and a positive result. In some examples, the driver / voltage regulator 502 uses the energy provided by the electromagnetic field to output a voltage, thereby allowing the wireless chip 114 to work without a source battery and / or battery power supply. In some examples, the driver / voltage regulator 502 controls the front-end channels 250, 260 to switch between electrodes. In some examples, the driver / voltage regulator 502 applies a potential (e.g., a voltage, a balance potential, etc.) to one or more of the example electrodes 202a-f to promote, assist, and / or improve a chemical reaction that causes hydrogen peroxide to flow from the test area of ​​the porous membrane 109 to the non-test area. For example, the driver / voltage regulator 502 can adjust the power supply voltage (e.g., 1.8V, 3.3V, and / or 5V) corresponding to the energy of the electromagnetic field to a smaller voltage (e.g., 200mV, 150mV, 100mV, etc.) and apply the adjusted voltage to one or more of the electrodes 202a-202f. The potential to improve one or more chemical reactions can correspond to a positive voltage or a negative voltage. The supply (e.g., application) of the potential can be applied via a working electrode or a counter electrode (e.g., corresponding to whether the voltage is positive or negative). The balance, bias, and / or voltage can be drawn from the generated voltage corresponding to the electromagnetic field that generates the current via the antenna 115.

[0132] Figure 5 An example sensor 504 may be a voltage sensor, a current sensor, an electromotive force sensor, or a resistance sensor. Figure 1A , 2A , 2B, 2D, 2E, 2G, 2H and / or 2L-2R of the fuel-based LFA device 104, the example sensor 504 is a voltage and / or current sensor that measures the voltage drop across one or more of the bioelectrochemical cells 111a-n and / or the current therebetween by sensing the voltage drop and / or current from a first pin coupled to the top of the bioelectrochemical cell and a second pin coupled to the bottom of the bioelectrochemical cell. In another example, for Figure 3AThe circuit of the LFA device 300 is completed, and the example sensor 504 is a current sensor that measures the amount of current through the test lines 302, 304 and / or the control area 306 by sensing the current from the first pin coupled to the first electrode 308a to the second pin coupled to the corresponding second electrode 308b. In another example, the example sensor 504 is an electromotive force sensor that measures the electromotive force between the first electrode 308a and the second electrode 308b and / or measures the electromotive force between the first pin coupled to the first part of the bioelectrochemical cell and the second pin coupled to the second part of the bioelectrochemical cell. If the example sensor 504 is a resistance sensor, the sensor 504 measures the amount of resistance from the first pin coupled to the first electrode 308a to the second pin coupled to the corresponding second electrode 308b.

[0133] Figure 5 The example comparator 506 compares the sensing resistance, current and / or voltage of each test zone and / or control zone with the threshold amount of resistance, voltage and / or current. The example comparator 506 can be a software-based comparator (e.g., comparing digital and / or analog voltage and / or current values ​​with threshold values), a firmware-based comparator and / or a hardware-based comparator (e.g., inputting digital and / or analog voltage and / or current to a first input, inputting threshold voltage and / or current to a second input, and outputting a logic value corresponding to whether the first input is higher than or lower than the second input). For example, if the sensor 504 determines the voltage drop across the first bioelectrochemical cell (e.g., bioelectrochemical cell 111a), the example comparator 506 compares the voltage with a threshold value (e.g., 50mV). If the comparator 506 determines that the voltage is higher than the threshold value, the comparator 506 outputs a first logic value (e.g., "1") and / or otherwise marks the result as a positive result for the corresponding target analyte and / or control zone. If the example comparator 506 determines that the voltage is below the threshold, the comparator 506 outputs a second logic value (eg, "0") and / or otherwise flags the result as a negative result for the target analyte and / or control zone.

[0134] Figure 5 The example result storage 508 stores the results (e.g., flags and / or logic values ​​corresponding to the test zone and / or control zone). In addition, the result storage 508 can store an identifier (e.g., a device identifier, an identifier of the number and / or type of tests and / or controls used in the machine-readable LFA device 104, 300, etc.). In this way, when sending the results to the reader 116, the antenna interface 500 can include the identifier with the results.

[0135] As disclosed herein, the test results are to be read at a specific time and / or within a specific time window to allow for the chemical reactions disclosed herein. Therefore, in some examples, the wireless chip 114 includes a timer 510 . Figure 5 The example timer 510 tracks the amount of time since one or more of the bioelectrochemical cells 111a-n have been activated (e.g., generated a voltage). For example, the bioelectrochemical cells 111a-n can apply the generated voltage of the LFA-based test to the example wireless chip 114 to power the wireless chip 114 while the test is being performed. Once powered by the voltage generated by one or more of the bioelectrochemical cells 111a-n, the timer 510 can initiate a wait timer to help identify when the LFA test is ready to be read. For example, the comparator 506 can compare the wait time with the assay time (e.g., corresponding to a threshold value for when the LFA test is ready to be read). In this way, if the reader 116 attempts to read the LFA 104 before the LFA 104 is ready, the wireless chip 114 can send timing information to the example reader 116 so that the reader 116 can determine that the test is not ready and / or determine when the test will be ready to be read.

[0136] Figure 5 The example analog-to-digital converter 512 converts analog voltage and / or current values ​​obtained (eg, sensed) from the sensor 504 into digital voltage and / or current values. In this manner, the example antenna interface 500 can transmit the digital values ​​to the example reader 116.

[0137] Figure 6 Yes Read Figure 1A , 1B , 2A, 2B, 2D, 2E, 2G, 2H, 2L-2R and / or 3A LFA devices Figure 1A 6. The exemplary machine-readable LFA reader application 117 includes an exemplary component interface 600, an exemplary result determiner 602, an exemplary test type storage 604, an exemplary result storage 606, and an exemplary timer / counter 608.

[0138] Figure 6The example component interface 600 interfaces with other components of the example reader 116. For example, the component interface 600 can transmit prompts, text and / or images to the example user interface 120 for display to the user. In addition, the example component interface 600 receives (e.g., accesses, obtains, etc.) data entered by the user via the user interface 120. For example, if the user enters identification information, patient information, demographic information, etc. into the user interface 120, the example component interface 600 obtains the input information from the user interface 120. In addition, the example component interface 600 interfaces with the antenna 118 to control the antenna 118 to output a magnetic field that can wirelessly power the example wireless chip 114 through the example antenna 115 and wirelessly receive (e.g., access, obtain, detect, etc.) data (e.g., test results, identifiers, etc.) from the example wireless chip 114. In some examples, the component interface 600 interfaces with the camera to obtain identification information through a picture and / or scan (e.g., QR code, bar code, etc.) of the LFA device 104. In some examples, the component interface 600 interfaces with a transmitter of the reader 116 (e.g., corresponding to the example antenna 118 and / or another transmitting device) to transmit the results of the LFA-based test readings to an entity monitoring the results. For example, the component interface 600 and the transmitter can transmit the results to an external or remote location over a network for inclusion in an ERM and / or otherwise to a healthcare institution, government agency, NGO, etc. The results can include which tests / controls were positive, which tests / controls were negative, identification information of the LFA device or tests and / or controls used, and / or contextual or supplemental information obtained from the reader 116 and / or user (e.g., timestamp, location data from a global positioning system sensor on the reader 116, patient information and / or demographic data, batch number, expiration date, deadline, test information, signal quality information, chain of custody, operator information, etc.). In this manner, if an entity monitoring the results determines that a particular LFA device has been used for more than a threshold percentage of a number, the LFA device may be flagged as potentially counterfeit, and subsequent actions may be taken to prevent further counterfeiting and / or reliance on test results of counterfeit devices. If a network connection is not available after performing the test, component interface 600 may send the results after receiving an indication that a network connection is available.

[0139] Figure 6The example result determiner 602 determines whether the test is ready and / or the result of the test based on the obtained result and / or identification information. For example, if the identification information is unknown, the example result determiner 602 obtains the identification information from the wireless chip 114. Additionally or alternatively, the example result determiner 602 may obtain the identification information by scanning a QR code on the LFA device 104 using a camera or instructing a user to manually enter a code on the LFA device 104. The result determiner 602 may then access the test number, test type, control number, and / or control type used on the LFA device 104, 300 from a test type storage 604 (e.g., which stores the identification information in combination with the corresponding test number, test type, control number, and / or control type used on the LFA device 104, 300) based on the identification information (e.g., device identifier, test and / or control structure identifier, etc.).

[0140] In some examples, the result determiner 602 authenticates the LFA device 104 based on the obtained identification information. For example, if the communication between the LFA device 104 and the wireless chip 114 is encrypted and the wireless chip 114 is not aware of the encryption protocol, the LFA device 104 will not be able to read the identification information. In this scenario, the result determiner 602 determines that the LFA device 104 is invalid or unauthorized.

[0141] Once the result determiner 602 determines which flags and / or binary values ​​correspond to each test and / or control, the example result determiner 602 determines whether the test is ready by comparing the result of the control with the result corresponding to the complete test. For example, if the machine-readable LFA device 104, 300 has a positive control area, the test is ready to be read when the positive control area corresponds to a positive test result. If the example result determiner 602 determines that the value and / or flag corresponding to the positive control area is not positive, the result determiner 602 determines that the test is not ready to be read, and the example component interface 600 outputs an error message or other informational message to the user through the user interface 120.

[0142] if Figure 6The result determiner 602 of example results determines that the test is ready to be read, then the result determiner 602 determines which tests have caused positive and / or negative results based on the corresponding values ​​and / or flags in the received results. The example result determiner 602 indicates that the component interface 600 displays the results to the user through the example user interface 120. In addition, the result determiner 602 can store the results in the example result storage device 606. The result determiner 602 can store the results in conjunction with the received identification information and / or any contextual information or supplementary information (for example, patient information, timestamp, demographic information, location information, batch number, expiration date, deadline, test information, signal quality information, chain of custody, operator information, etc.).

[0143] Figure 6 The example test type storage device 604 stores information corresponding to the number(s) and / or type(s) of tests and the number(s) and / or type(s) of controls in combination with identification information (e.g., device identification, test structure identification, etc.). In this way, when the identification information of the example LFA device 104, 300 is obtained, the example result determiner 602 can identify how the results correspond to different controls and / or tests.

[0144] Figure 6 The exemplary result storage 606 stores the results of the LFA tests (e.g., which tests presented positive results, negative results, or indeterminate results and / or any corresponding information) in combination with any identifying information (e.g., data matrix code, test identifier, etc.). In some examples, a user may enter patient information through the user interface 120. In such examples, some or all of the patient information may be added to the result information (e.g., the result storage 606 stores a record of the test results in combination with the patient information). Additionally or alternatively, the exemplary component interface 600 may collect contextual information when performing the test, which may be stored in the exemplary result storage 606 in combination with the results (e.g., location information, time of day information, etc.).

[0145] Figure 6The example timer / counter 608 tracks one or more durations (e.g., time periods) to determine whether a test should be marked as invalid or potentially invalid. For example, a test may be invalid when a user performs an action after a defined duration. For example, after the user has verified that the sample and / or buffer has been applied, the exemplary timer / counter 608 tracks a first duration corresponding to when the test will be ready to be read. In addition, the timer / counter 608 can track a second duration corresponding to when the user rescans the LFA device 104 to verify that it is the correct LFA device to be read. In addition, the timer / counter 608 can track a third duration corresponding to when the user stops the flow. (Multiple) durations can be based on a test algorithm corresponding to a test type and / or LFA device type. In some examples, the timer / counter 608 outputs a timing window (e.g., a clock and / or countdown corresponding to one or more time periods) to the user via the user interface 120.

[0146] Although in Figure 4 The implementation is shown in Figure 1A An exemplary machine-readable LFA generator 102 of the exemplary embodiment of the present invention is shown in FIG. Figure 5 The implementation is shown in Figure 1A , 2A , 2B, 2G, 2I-2K and / or 3A, and in an exemplary manner of an exemplary wireless chip 114 Figure 6 The implementation is shown in Figure 1A The exemplary machine-readable LFA reader application 117 of the exemplary method, but Figure 4-6 One or more of the elements, processes and / or devices shown in the example may be combined, split, rearranged, omitted, eliminated and / or implemented in other ways. In addition, the example user interface 400, the example component generator 402, the example component applicator 404, the example antenna interface 500, the example driver / voltage regulator 502, the example sensor 504, the example comparator 506, the example result storage 508, the example component interface 600, the example result determiner 602, the example test type storage 604, the example result storage 606 and / or more generally, Figure 4-6The example machine-readable LFA generator 102, the example wireless chip 114, and / or the example machine-readable LFA reader application 117 may be implemented by hardware, software, firmware, and / or any combination of hardware, software, and / or firmware. Thus, for example, the example user interface 400, the example component generator 402, the example component applicator 404, the example antenna interface 500, the example driver / voltage regulator 502, the example sensor 504, the example comparator 506, the example result storage 508, the example component interface 600, the example result determiner 602, the example test type storage 604, the example result storage 606, and / or more generally, Figure 4-6 The exemplary machine-readable LFA generator 102, exemplary wireless chip, and / or exemplary machine-readable LFA reader application 117 may be implemented by one or more analog or digital circuits, logic circuits, programmable processors, programmable controllers, graphics processing units (GPUs), digital signal processors (DSPs), application-specific integrated circuits (ASICs), programmable logic devices (PLDs), and / or field programmable logic devices (FPLDs). When any apparatus or system claim of this patent is understood to cover pure software and / or firmware implementations, the exemplary user interface 400, the exemplary component generator 402, the exemplary component applicator 404, the exemplary antenna interface 500, the exemplary driver / voltage regulator 502, the exemplary sensor 504, the exemplary comparator 506, the exemplary result storage device 508, the exemplary component interface 600, the exemplary result determiner 602, the exemplary test type storage device 604, the exemplary result storage device 606, and / or more generally Figure 4-6 The exemplary machine-readable LFA generator 102, exemplary wireless chip 114, and / or exemplary machine-readable LFA reader application 117 are expressly defined herein as including a non-transitory computer-readable storage device or storage disk, such as a memory, a digital versatile disk (DVD), a compact disk (CD), a Blu-ray disk, etc., including software and / or firmware. In addition, Figure 4 An exemplary machine-readable LFA generator 102 of Figure 5 An exemplary wireless chip 114 and Figure 6 An exemplary machine-readable LFA reader application 117 may include in addition to or in lieu of Figure 4-6One or more elements, processes and / or devices other than the one or more elements, processes and / or devices shown, and / or may include more than one of any or all of the elements, processes and devices shown. As used herein, the phrase "communication" includes variations thereof, including direct communication and / or indirect communication through one or more intermediate components, and does not require direct physical (e.g., wired) communication and / or continuous communication, but also includes selective communication at periodic intervals, predetermined intervals, non-periodic intervals and / or one-time events.

[0147] Figure 7-11B shows a representative for implementing Figure 4-6 Flowcharts of example hardware logic, machine-readable instructions, hardware-implemented state machines, and / or any combination thereof of the machine-readable LFA generator 102, the example wireless chip 114, and / or the machine-readable LFA reader application 117. The machine-readable instructions may be one or more executable programs or (a plurality of) portions of executable programs for execution by a computer processor, such as the following in conjunction with Fig.12 , 13 The program may be embodied in software stored on a non-transitory computer-readable storage medium associated with the processor 1212, 1312, 1412, such as a CD-ROM, floppy disk, hard drive, DVD, Blu-ray disk, or memory, but the entire program and / or portions thereof may alternatively be executed by a device other than the processor 1212, 1312, 1412 and / or embodied in firmware or dedicated hardware. Furthermore, although reference is made to Figure 7-11B The flowcharts shown describe example procedures, but many other methods of implementing the example machine-readable LFA generator 102, the example wireless chip 114, and / or the example machine-readable LFA reader application 117 may alternatively be used. For example, the order of execution of the blocks may be changed, and / or some of the blocks described may be changed, deleted, or combined. Additionally or alternatively, any or all of the blocks may be implemented by one or more hardware circuits (e.g., discrete and / or integrated analog and / or digital circuits, FPGAs, ASICs, comparators, operational amplifiers (op-amps), logic circuits, etc.) that are configured to perform corresponding operations without executing software or firmware.

[0148] The machine-readable instructions described herein may be stored in one or more of a compressed format, an encrypted format, a segmented format, a compiled format, an executable format, a packaged format, etc. The machine-readable instructions described herein may be stored as data (e.g., portions of instructions, codes, code representations, etc.) that may be used to create, manufacture, and / or generate machine-executable instructions. For example, the machine-readable instructions may be segmented and stored on one or more storage devices and / or computing devices (e.g., servers). The machine-readable instructions may require one or more of installation, modification, adaptation, update, combination, supplementation, configuration, decryption, decompression, unpacking, distribution, redistribution, compilation, etc., so that they can be directly read, interpreted, and / or executed by a computing device and / or other machine. For example, the machine-readable instructions may be stored in a plurality of components that are individually compressed, encrypted, and stored on separate computing devices, wherein the components, when decrypted, decompressed, and combined, form a set of executable instructions that implement a program such as described herein.

[0149] In another example, the machine-readable instructions may be stored in a state in which they can be read by a computer, but require the addition of a library (e.g., a dynamic link library (DLL)), a software development kit (SDK), an application programming interface (API), etc., in order to execute the instructions on a particular computing device or other device. In another example, the machine-readable instructions and / or corresponding program(s) may need to be configured (e.g., stored settings, data inputs, recorded network addresses, etc.) before the machine-readable instructions and / or corresponding program(s) can be executed in whole or in part. Thus, the disclosed machine-readable instructions and / or corresponding program(s) are intended to encompass such machine-readable instructions and / or program(s) regardless of the particular format or state of the machine-readable instructions and / or program(s) when stored or otherwise at rest or in transit.

[0150] The machine-readable instructions described herein may be represented by any past, present or future instruction language, scripting language, programming language, etc. For example, the machine-readable instructions may be represented using any of the following languages: C, C++, Java, C#, Perl, Python, JavaScript, Hypertext Markup Language (HTML), Structured Query Language (SQL), Swift, etc.

[0151] As mentioned above, Figure 7-11BThe example processes of may be implemented using executable instructions (e.g., computer and / or machine readable instructions) stored on a non-transitory computer and / or machine readable medium, such as a hard drive, flash memory, read-only memory, compact disk, digital versatile disk, cache, random access memory, and / or any other storage device or storage disk in which information is stored for any duration (e.g., for an extended period of time, permanently, temporarily, for temporary buffering, and / or for caching information). As used herein, the term non-transitory computer readable medium is expressly defined to include any type of computer readable storage device and / or storage disk, and to exclude propagating signals and to exclude transmission media.

[0152] Figure 7 An example flow chart representing machine readable instructions 700 that may be executed to implement Figure 4 The exemplary machine-readable LFA generator 102 of Figure 1A , 1B , 2A, 2B, 2D, 2E, 2H, 2L-2R, and / or 3A. Although Figure 7 The instruction 700 is combined with Figure 1A , 1B , 2A, 2B, 2D, 2E, 2H, 2L-2R and / or 3A, but the example instructions 700 may be described and / or implemented in conjunction with any type of LFA device of any structure.

[0153] At block 702, the example user interface 400 determines whether instructions to generate a machine-readable LFA device 104, 300 have been obtained. If the example user interface 400 determines that instructions have not been obtained (block 702: No), control returns to block 702 until instructions are obtained. If the example user interface 400 determines that instructions have been obtained (block 702: Yes), the example component generator 402 determines the number of tests, the type(s) of the test(s), the number of control zones, and / or the type(s) of control zones based on the user instructions (block 704). For example, a user may provide instructions to generate an LFA device 104, 300 to include three test zones corresponding to three target analytes and one positive control zone.

[0154] At block 706, the exemplary component generator 402 designs and / or obtains a conjugate pad based on the type(s) of test(s) and / or LFA structure(s) identified in the instructions. For example, the component generator 402 may generate (and / or obtain from a storage device) a conjugate pad comprising an antibody and / or antigen attached to a target analyte corresponding to the type(s) of test(s) identified in the instructions. For the bioelectrochemical cell LFA device 104, the antigen and / or antibody is attached to GOx or gold nanoparticles (e.g., depending on how the bioelectrochemical cells 111a-n are constructed). For the circuit-complete LFA device 300, the antigen and / or antibody is attached to gold nanoparticles.

[0155] At block 708, the exemplary component generator 402 generates and / or obtains an exemplary sample pad 106, an exemplary porous medium 109, an exemplary wicking pad 112, an exemplary wireless chip 114, an exemplary antenna 115, and / or an LFA housing. At block 710, the exemplary component applicator 404 applies (e.g., solidifies) the antigen and / or antibody corresponding to the target analyte to the test zone and / or control zone in the test area 110 of the porous medium 109 and / or accesses the target analyte. At block 712, the exemplary component generator 402 determines whether the instruction corresponds to an LFA as a bioelectrochemical cell LFA device 104 (e.g., as opposed to the circuit-completed LFA device 300). If the component generator 402 determines that the LFA does not correspond to the bioelectrochemical cell LFA device 104 (block 712: No), control continues to block 716. If the component builder 402 determines that the LFA corresponds to a bioelectrochemical cell LFA device 104 (block 712: yes), the example component builder 402 generates and / or obtains a bioelectrochemical cell (block 714). The example component builder 402 generates the bioelectrochemical cell by impregnating a piece of paper or other substrate with an enzyme substrate (e.g., glucose) and / or a reducing agent (e.g., hydroquinone, aminophenol, vitamin C, other ascorbic acid, etc.) and / or an electron mediator or redox substance (e.g., potassium ferrocyanide, ferrocene, ferrocene derivatives, etc.). Once impregnated, the example component builder 402 allows the bioelectrochemical cell to dry before applying it to the LFA device 104.

[0156] At block 716, the exemplary component applicator 404 generates (e.g., assembles and / or applies) one of the machine-readable LFAs 104, 300, including the sample pad 106, the exemplary conjugate pad 108, the exemplary porous medium 109, the exemplary wicking pad 112, the exemplary wireless chip 114, the exemplary antenna 115, wiring or etching (e.g., connecting the wireless chip 114 to the test area and / or battery), the electrodes 202a-f, the switch 278, the flow stop 280, the electrode plate 282, the actuator 193 and / or the LFA housing. At block 718, the exemplary component applicator 404 applies the exemplary inlet 113 (e.g., by cutting away a portion of the LFA device 104, 300). In some examples, the inlet may not be included. For example, for a circuit-complete LFA device 300, a silver amplification material may be applied to the exemplary sample pad 106 to flow through the exemplary wires 302, 304, 306.

[0157] Fig. 8A An example flow diagram representing machine readable instructions 800 that may be executed to implement Figure 5 The example wireless chip 114 determines the Figure 1A , 1B , 2A, 2B, 2D, 2E, 2G, 2H, and / or 2L-2R, the results of testing of the example bioelectrochemical cell LFA device 104. Fig. 8A The instruction 800 is combined with Figure 1A , 1B , 2A, 2B, 2D, 2E, 2G, 2H, and / or 2L-2R. The example instructions 800 may be described and / or implemented in conjunction with any type of LFA device of any structure. The example instructions 800 may be described and / or implemented in conjunction with any type of LFA device of any structure, including, for example, Figure 3A and 3B LFA equipment.

[0158] At block 801, the example antenna interface 500 obtains power via the antenna 115. For example, the example reader 116 generates a local electromagnetic field that induces a current in the example antenna 115 to power the example wireless chip 114. At block 802, the example driver / voltage regulator 502 reduces (e.g., caps, regulates, etc.) the power supply voltage (e.g., 1.8V, 3.3V, and / or 5V corresponding to the obtained power) to a smaller voltage (e.g., 100mV, 150mV, 200mV, 250mV, etc.), which is applied as a potential to assist the chemical reaction at the porous membrane 109. At block 803, the example driver / voltage regulator 502 applies a potential (e.g., a voltage, an equilibrium potential, etc.) to one of the electrodes of the electrode pair (e.g., (multiple) working electrodes and / or (multiple) reference electrodes, depending on whether the potential is a positive potential or a potential position) using the smaller voltage. As described above, by providing more optimal conditions for the occurrence of chemical reactions, a smaller voltage can help and / or force one or more chemical reactions to occur, resulting in a stronger current measurement. In some examples, the driver / voltage regulator 502 can apply multiple potentials (e.g., voltages, equilibrium potentials, etc.) to facilitate a variety of different chemical reactions that produce current when the target analyte is present. At block 804, the example sensor 504 senses the voltage drop and / or current between the corresponding pins coupled to the test and / or control zones via the example electrodes 308a, 308b. The example sensor 504 can sense the voltage drop and / or current of each zone in series or in parallel.

[0159] At block 806, the exemplary comparator 506 determines whether the voltage drop and / or current is greater than a threshold value for one or more corresponding pins. For example, the comparator 506 can determine whether the sensed voltage drop and / or current for each test and / or control is greater than 50 mV. In some examples, the comparator 506 determines whether the voltage drop and / or current exceeds a plurality of different threshold values. In this manner, the comparator 506 can determine what the amount of sensed voltage drop and / or current is, as described above in conjunction with Figures 2A-2K If the example comparator 506 determines that the voltage drop and / or current is not greater than the threshold value of one or more corresponding pins (block 806: No), control continues to block 810. If the example comparator 506 determines that the voltage drop and / or current is greater than the threshold value of one or more corresponding pins (block 806: Yes), the example comparator 506 marks (e.g., flags or outputs a logic value) the corresponding (multiple) test regions and / or (multiple) control regions as corresponding to a positive result (block 808). The example result storage device 508 stores the (multiple) flags associated with the (multiple) corresponding regions, as further disclosed below at block 814.

[0160] At block 810, the example comparator 506 determines whether the voltage drop and / or current is less than a threshold value for one or more corresponding pins. For example, the comparator 506 may determine whether the sensed voltage drop and / or current for each test and / or control is less than 50 mV. If the example comparator 506 determines that the voltage drop and / or current is not less than a threshold value for one or more corresponding pins (block 810: No), control continues to block 814. If the example comparator 506 determines that the voltage drop and / or current is less than a threshold value for one or more corresponding pins (block 810: Yes), the example comparator 506 marks (e.g., flags or outputs a logic value) the corresponding (multiple) test zones and / or (multiple) control zones as corresponding to a negative result (block 812). At block 814, the example result storage device 508 stores the (multiple) marks associated with the (multiple) corresponding zones and / or the example antenna interface 500 sends (e.g., via the antenna 115) the result corresponding to the mark. The antenna 115 may also transmit identification information (eg, device identifier, test number and / or type identifier, control number and / or type identifier) ​​along with the results.

[0161] Figure 8B An example flow chart showing alternative machine-readable instructions 820 that may be executed to implement Figure 5 The example wireless chip 114 is used to determine the Figure 1A , 1B , 2A, 2B, 2D, 2E, 2G, 2H, and / or 2L-2R, the results of testing of the example bioelectrochemical cell LFA device 104. Figure 8B The instruction 820 is combined with Figure 1A , 1B , 2A, 2B, 2D, 2E, 2G, 2H, and / or 2L-2R. The example instructions 820 may be described and / or implemented in conjunction with any type of LFA device in any configuration. The example instructions 800 may be described and / or implemented in conjunction with any type of LFA device in any configuration, including, for example, Figure 3A and 3B LFA equipment.

[0162] At block 821, the example antenna interface 500 obtains power via the antenna 115. For example, the example reader 116 generates a local electromagnetic field that induces a current in the example antenna 115 to power the example wireless chip 114. At block 822, the example driver / voltage regulator 502 reduces (e.g., caps, regulates, etc.) the power supply voltage (e.g., 1.8V, 3.3V, and / or 5V) corresponding to the obtained power to a smaller voltage (e.g., 100mV, 150mV, 200mV, 250mV, etc.), which will be used as a potential to assist the chemical reaction at the porous membrane 109. At block 823, the example driver / voltage regulator 502 applies a potential (e.g., voltage, equilibrium potential, bias, etc.) to one of the electrodes of the electrode pair (e.g., (multiple) working electrodes and / or (multiple) reference electrodes, depending on whether the potential is a positive potential or a potential position) using the smaller voltage. As described above, by providing more optimal conditions for the chemical reaction to occur, a smaller voltage can help and / or force the chemical reaction to occur, resulting in a stronger current measurement. In some examples, the driver / voltage regulator 502 can apply multiple potentials (e.g., voltages, equilibrium potentials, etc.) to facilitate multiple different chemical reactions that produce current in the presence of the target analyte.

[0163] At block 824, the exemplary driver / voltage regulator 502 switches between the electrode pairs so that the sensor 504 can obtain one or more voltage samples and / or current samples between the corresponding pins coupled to the test and / or control zones. For example, the driver / voltage regulator 502 can trigger a selection line of one of the example front ends 240, 250 to allow the sensor 504 to sense the voltage drop and / or current between the corresponding electrodes. As described above, the driver / voltage regulator 502 can control the front ends 240, 250 to obtain multiple samples of each test line and / or control line. In some examples, the sensor 504 can obtain the voltage / current directly from the channel of the front end 260 without switching. Additionally or alternatively, the exemplary LFA device 104 can obtain any data corresponding to the test results. In some examples, the driver / voltage regulator 502 can apply a single potential before switching. In some examples, the driver / voltage regulator 502 outputs a potential before each voltage and / or current measured within the switch. At block 826, the exemplary analog-to-digital converter 512 converts the analog voltage and / or current measurement into (multiple) digital values. At block 828, the example antenna interface 500 transmits (e.g., via the antenna 115) the digital voltage value of the zone along with corresponding information (e.g., device identifier, test type identifier, product code, etc.) to the reader 116. In some examples, block 826 may be omitted, and the example antenna interface 500 may transmit analog voltage and / or current measurements to the example reader 116. In some examples, the wireless chip 114 may compare the measured value to one or more thresholds to generate a result, as described above in conjunction with Fig. 8A Further described.

[0164] Fig. 9 An example flow chart representing machine readable instructions 900 that may be executed to implement Figure 5 The example wireless chip 114 determines the Figure 1A , 1B , 2A, 2B, 2D, 2E, 2G, 2H, and / or 2L-2R, are results of testing of an example bioelectrochemical cell LFA device 104 powered by a voltage generated by one or more of the bioelectrochemical cells 111a-111n. Fig. 9 Instruction 900 is combined with Figure 1A , 1B , 2A, 2B, 2D, 2E, 2G, 2H and / or 2L-2R, but the example instructions 900 may be described and / or implemented in conjunction with any type of LFA device in any structure.

[0165] At block 902, the example wireless chip 114 obtains power from one or more of the bio-electrochemical cells 111a-n. As described above, when one or more test zones and / or control zones solidify the target analyte, a voltage is generated at one or more bio-electrochemical cells 111a-n. The generated voltage can be used to power the wireless chip 114. At block 904, the example timer 510 initiates a wait timer. When the wait timer reaches a threshold amount of time (e.g., an assay time), the test is ready to be read. In this way, if the reader 116 attempts to read the LFA 104 before the LFA 104 is ready to be read, the wireless chip 114 can send the wait time and / or the assay time so that the reader 116 can display how much time is left before the LFA 104 is ready to be read.

[0166] At block 906, the example antenna interface 500 determines whether an electromagnetic field is sensed through the example antenna 115. When the reader 116 attempts to read the LFA 104, the reader 116 generates an electromagnetic field to initiate communication with the wireless chip 114. If the example antenna interface 500 determines that an electromagnetic field is not sensed (block 906: No), control returns until an electromagnetic field is sensed. If the example antenna interface 500 determines that an electromagnetic field is sensed (block 906: Yes), the comparator 506 determines whether the waiting time (e.g., from the example timer 510) is greater than the assay time (e.g., a threshold time corresponding to a test ready to be read) (block 908). If the example comparator 506 determines that the waiting time is not greater than the assay time (block 908: No), the example antenna interface 500 interfaces with the antenna 115 to transmit timing information (e.g., the current waiting time and / or the assay time) to the example reader 116 (block 910). In this way, the reader 116 can determine how much time is still required and / or display the amount of time to the user. Premature result readings and / or other result reading errors are prevented because process 900 includes determining whether the wait time is greater than the assay time.

[0167] If the example comparator 506 determines that the waiting time is greater than the assay time (block 908: yes), the example sensor 504 senses the voltage drop between the corresponding pins coupled to the test and / or control zones via the example electrodes 308a, 308b (block 914). The example sensor 504 may sense the voltage drop of each zone in series or in parallel. At block 916, the example comparator 506 determines whether the voltage drop is greater than the threshold of one or more corresponding pins. For example, the comparator 506 may determine whether the sensed voltage drop of each test and / or control is greater than 50mV. If the example comparator 506 determines that the voltage drop is not greater than the threshold of one or more corresponding pins (block 916: no), control continues to block 920. If the example comparator 506 determines that the voltage drop is greater than the threshold of one or more corresponding pins (block 916: yes), the example comparator 506 marks (e.g., marks or outputs a logic value) the corresponding (multiple) test zones and / or (multiple) control zones as corresponding to a positive result (block 918). The example results storage 508 stores the flag(s) in conjunction with the corresponding region(s), as further disclosed below at block 924 .

[0168] At block 920, the example comparator 506 determines whether the voltage drop is less than a threshold value of one or more corresponding pins. For example, the comparator 506 may determine whether the sensed voltage drop of each or a corresponding one of the tests and / or controls is less than 50 mV. If the example comparator 506 determines that the voltage drop is not less than a threshold value of one or more corresponding pins (block 920: No), control continues to block 924. If the example comparator 506 determines that the voltage drop is less than a threshold value of one or more corresponding pins (block 920: Yes), the example comparator 506 marks (e.g., marks or outputs a logical value) the corresponding (multiple) test area and / or (multiple) control area as corresponding to a negative result (block 922). At block 924, the example result storage device 508 stores the (multiple) marks associated with the corresponding (multiple) area, and / or the example antenna interface 500 transmits (e.g., via the antenna 115) the result corresponding to the mark. The antenna 115 may also transmit identification information (e.g., device identifier, test number and / or type identifier, control number and / or type identifier) ​​with the result.

[0169] Fig.10 An example flow diagram representing machine readable instructions 1000 that may be executed to implement Figure 5 The example wireless chip 114 is used to determine the Figure 3A The example circuitry of the LFA device 300 is shown in Figure 3. Figure 3A The exemplary machine-readable LFA device 300 describes Fig.10The example instructions 1000 are for use with the present invention, but the example instructions 1000 may be described and / or implemented in conjunction with any type of LFA device in any structure.

[0170] At block 1002, the example antenna interface 500 obtains power via the antenna 115. For example, the example reader 116 generates a local electromagnetic field that induces a current in the example antenna 115 to power the example wireless chip 114. At block 1004, the example driver / voltage regulator 502 outputs a voltage to a first pin coupled to the first electrode 308a of the (multiple) test area and / or the (multiple) control area. The example driver / voltage regulator 502 can output a voltage to each of the first pins in parallel or serially. In some examples, the voltage output by the driver / voltage regulator 502 corresponds to the power obtained via the electromagnetic field of the reader 116. In this way, the wireless chip 114 can output a voltage without using a storage unit and / or a battery unit. At block 1006, the example sensor 504 senses the current and / or resistance from the second pin of the second electrode 308b coupled to the (multiple) test area and / or the (multiple) control area.

[0171] At block 1008, the exemplary comparator 506 determines whether the current is greater than a threshold value for one or more corresponding pins, or whether the resistance is less than a threshold value. For example, the comparator 506 can determine whether the sensed current for each test and / or control is within a defined range. In some examples, the comparator 506 determines whether the current / resistance is greater than a plurality of different threshold values. In this manner, the comparator 506 can determine what the sensed current / resistance is, as described above in conjunction with Figures 2A-2K If the example comparator 506 determines that the current is not greater than the threshold value of one or more corresponding pins or the resistance is not less than the threshold value (block 1008: No), control continues to block 1012. If the example comparator 506 determines that the current is greater than the threshold value of one or more corresponding pins or the resistance is less than the threshold value (block 1008: Yes), the example comparator 506 marks (e.g., marks or outputs a logical value) the corresponding (multiple) test areas and / or (multiple) control areas as corresponding to a positive result (block 1010). The example result storage device 508 stores the (multiple) marks associated with the corresponding (multiple) areas, as further disclosed below in block 1016.

[0172] At block 1012, the exemplary comparator 506 determines whether the current is less than the threshold of one or more corresponding pins, or whether the resistance is greater than the threshold. For example, the comparator 506 can determine whether the sensed current of each test and / or control is within a defined range of current and / or resistance. In other examples, the comparator 506 performs a comparison measurement for a specific value. For example, in an example embodiment, the comparator 506 can determine whether the sensed current of the test and / or control is less than 50mA and / or whether the sensed resistance is greater than 100 ohms. In other examples, other values ​​can be used. If the exemplary comparator 506 determines that the current is not less than the threshold of one or more corresponding pins or the resistance is not greater than the threshold (block 1012: No), control continues to block 1016. If the exemplary comparator 506 determines that the current is less than the threshold of one or more corresponding pins or the resistance is greater than the threshold (block 1012: Yes), the exemplary comparator 506 marks the corresponding (multiple) test area and / or (multiple) control area (e.g., marks or outputs a logic value) as corresponding to a negative result (block 1014). At block 1016, the exemplary result storage 508 stores the (multiple) marks associated with the corresponding (multiple) zones, and / or the exemplary antenna interface 500 sends (e.g., via the antenna 115) the results corresponding to the marks. The antenna 115 may also send identification information (e.g., device identifier, test quantity and / or type identifier, control quantity and / or type identifier) ​​together with the results. In some examples, the result storage 606 may store a mark indicating that the result has been determined. The mark may be included in the result of subsequent reading. In this way, the exemplary reader 116 may identify that the test has been read.

[0173] Figures 11A-11B An example flow diagram representing machine readable instructions 1100 that may be executed to implement Figure 6 The exemplary machine-readable LFA reader application 117 reads Figure 1A , 1B , 2A, 2B, 2D, 2E, 2G, 2H, 2L-2R, and / or 3A of the exemplary machine-readable LFA device 104, 300 test results (e.g., diagnostic test results). Figure 1A , 1B , 2A, 2B, 2D, 2E, 2G, 2H, 2L-2R, and / or 3A, the exemplary machine-readable LFA device 104, 300 describes Figures 11A-11B The exemplary instructions 1100 are not limited to the exemplary LFA type, but the exemplary instructions 1100 may be described and / or implemented in conjunction with any structured LFA type.

[0174] The result determiner 602 instructs the component interface 600 to interact with the user of the reader 116 through the user interface 120. The result determiner 602 may send one or more prompts to the user and wait for confirmation from the user. For example, if the test of the LFA 104 is not autonomous or semi-autonomous, when the application 117 is started on the reader 116, the result determiner 602 may send instructions to the user of the reader 116. For example, at block 1102, the example result determiner 602 outputs a prompt to the user of the reader 116, which instructs the user to enter patient information (e.g., name, age, date of birth, gender, etc.). For example, the result determiner 602 instructs the component interface 600 to interact with the user through the user interface 120. The result determiner 602 may send one or more prompts to the user and wait for confirmation from the user. The patient information may be included in the corresponding information that may be displayed, stored and / or transmitted to an external database and / or server (e.g., marked to the result, included as metadata of the result, etc.). In some examples, the external / remote databases and / or servers are located at or associated with an EMR, government agency, non-governmental organization, physician's office, hospital, hospital information system, LIMS system, inventory consumption monitor, clinic and / or other medical institution, medical device manufacturer, medical organization, health information system, and / or other external entity.

[0175] The result determiner 602 also sends a prompt to the user to register the LFA 104 and / or identify the type of the LFA 104. At block 1104, the result determiner 602 instructs the example antenna 118 via the example component interface 600 to generate a magnetic field to power the wireless chip 114 for a first scan (e.g., to identify the LFA device 104). In this way, the wireless chip 114 can provide information to the reader 116 (e.g., wirelessly via the example antenna 115) when powered. In some examples, the reader 104 can obtain the identification information by scanning a QR code on the LFA device 104 using a camera or having the user manually enter a code on the LFA device 104. The LFA reader application 117 presents instructions to the user to scan the LFA device 104 (e.g., bring the reader 116 operating the reader application 117 near the LFA device 104). At block 1106, the example result determiner 602 obtains a test identifier (e.g., corresponding to one or more tests that the LFA device is constructed to perform), an LFA device identifier, a product code, and / or any other encoded or unencoded data from the wireless chip 114. The obtained information may be included in corresponding information that may be displayed, stored, and / or transmitted to an external database and / or server (e.g., tagged to the result, included as metadata for the result, etc.). In some examples, the result determiner 602 uses the obtained information to determine a test type and / or corresponding algorithm to be used when obtaining data corresponding to the test result from the LFA device 104. In some examples, the result determiner 602 uses the obtained information to authenticate the LFA device 104 and / or prevent the use of an invalid or unauthorized LFA device 104.

[0176] At block 1108, the example result determiner 602 determines the geographic location of the LFA device 104. In some examples, the component interface 600 accesses location information from other components of the reader 116 (e.g., if the reader 116 includes a GPS system). In some examples, the geographic location information is received (e.g., accessed, obtained, etc.) from the wireless chip 114. The geographic location information may be included (e.g., tagged to the result, included as metadata of the result, etc.) in the corresponding information, which may be displayed, stored, and / or transmitted to an external database and / or server.

[0177] At block 1110, the example result determiner 602 guides the user of the reader 116 through LFA reading instructions. For example, the result determiner 602 can send instructions to (1) instruct the user to apply a sample to the sample pad 106 and wait for user confirmation, (2) instruct the user to apply an assay buffer and wait for user confirmation, (3) instruct the user to wait for the LFA test, display a time and / or wait for user confirmation, (4) instruct the user to apply a reaction buffer and wait for user confirmation, (5) instruct the user to wait for a reaction to occur, display a time and / or wait for user confirmation, etc. In some examples, if, for example, a confirmation is not received within a threshold time range, the result determiner 602 can display an error. In semi-automatic or fully automatic LFA, some instructions can be eliminated because the LFA 104 can automatically perform one or more steps without the need for a user. The added information can be included (e.g., tagged to the result, included as metadata for the result, etc.) in the corresponding information that can be displayed, stored, and / or transmitted to an external database and / or server. In some examples, the external database and / or server is a hospital, hospital information system, LIMS system, inventory consumption monitor, medical institution, medical device manufacturer, etc.

[0178] At block 1112, the example component interface 600 determines whether the user has verified that the sample and / or buffer has been applied to the example LFA 104 (e.g., via a confirmation on the user interface 120). If the example component interface 600 determines that the user has not verified that the sample and / or buffer has been applied (block 1112: No), control returns to block 1112 until the user has verified. If the example component interface 600 determines that the user has verified that the sample and / or buffer has been applied (block 1112: Yes), the example result determiner 602 determines whether flow should be stopped (block 1114). In some examples, the result determiner 602 determines whether to stop flow by tracking a time window that is based on test and / or LFA identification information. For example, Figure 2A-2E The LFA device 104 of and / or 2L-2R uses techniques such as, for example, shearing, cutting, compression, etc. to reduce or prevent flow over the porous membrane 109 , thereby preventing products (eg, hydrogen peroxide) generated on the test or control line from flowing to the wicking pad 112 .

[0179] If the example component interface 600 determines that flow should not be stopped (block 1114: No), control proceeds to block 1114 until the time window ends. If the example component interface 600 determines that flow along the LFA device 104 should be stopped (block 1114: Yes), the example component interface 600 instructs the user to scan the LFA device 104 (block 1116). Because the user may be conducting multiple tests from multiple LFA devices simultaneously in a short duration, the user may be confused about which test is ready to be read. Therefore, the LFA reader application 117 instructs the user to scan the LFA device 104 to verify that the device scanned by the user is the correct device to proceed forward, thereby preventing errors associated with conducting multiple tests simultaneously and / or during a short duration.

[0180] At block 1118, the example result determiner 602 instructs the example antenna 118 via the example component interface 600 to generate a magnetic field to power the wireless chip 114 to perform a second scan (e.g., to verify that the user is reading the correct LFA device 104). At block 1120, the example result determiner 602 determines whether the LFA device identification is verified (e.g., whether the identification of the first scan matches the identification of the second scan). If the example result determiner 602 determines that the LFA device identification has been verified (block 1120: yes), control continues to Fig. 11B 1126. If the example result determiner 602 determines that the LFA device identification has not been verified (e.g., the identifier from the second scan does not match the identifier from the first scan) (block 1120: No), the example result determiner 602 determines whether a scan window (e.g., an amount of time corresponding to when the LFA device 104 should be verified based on the test and / or LFA device type has ended) has ended (block 1122). If the scan window has ended, the results may be less accurate. In some examples, the component interface 600 displays a timer corresponding to the test window in the example user interface 120.

[0181] If the example result determiner 602 determines that the scan window has not ended (block 1122: No), control returns to block 1116. If the example result determiner 602 determines that the scan window has ended (block 1122: Yes), the example result determiner 602 marks the test as potentially invalid (block 1124), and control returns to block 1116. In some examples, the test may continue, but the result will be marked as being read after the scan window (e.g., along with timing information corresponding to how long after the scan window the result is determined). In some examples, the test is marked as invalid, and the component interface 600 identifies the test as invalid.

[0182] At block 1126, the example component interface 600 sends a prompt to the user to stop the flow of the LFA device 104 (block 1114). For example, the component interface 600 may prompt the user to move the switch 278, 292 from the first position to the second position to cause the flow stopper 280 to cut, shear, compress, and / or otherwise stop obstructing and / or preventing the flow. At block 1128, the result determiner 602 determines whether the user has verified that the flow has stopped (e.g., via a prompt on the user interface 120). If the example result determiner 602 determines that the user has verified that the flow has stopped (block 1128: yes), control continues to block 1134. If the example result determiner 602 determines that the user has not verified that the flow has stopped (block 1128: no), the example result determiner 602 determines whether the stop flow window (e.g., based on the test and / or LFA device type, corresponding to the amount of time that the LFA device 104 should be sheared has ended) has ended (block 1130). If the stop flow window has ended, the results may be less accurate. In some examples, the component interface 600 displays a timer corresponding to the test window in the example user interface 120 .

[0183] If the example result determiner 602 determines that the stop flow window has not ended (block 1130: No), control returns to block 1126. If the example result determiner 602 determines that the scan window has ended (block 1130: Yes), the example result determiner 602 marks the test as potentially invalid (block 1132), and control returns to block 1126. In some examples, the test may continue, but the result will be marked as being read after the stop flow window (e.g., along with timing information corresponding to how long after the stop flow window the result is determined). In some examples, the test is marked as invalid, and the component interface 600 identifies the test as invalid.

[0184] At block 1134, the example component interface 600 instructs the user to scan the LFA device 104. At block 1136, the result determiner 602 instructs the example antenna 118 via the example component interface 600 to generate a magnetic field to power the wireless chip 114 to perform a third scan (e.g., obtain a digital value from the LFA device 104). As described above, the digital value may correspond to sensed (multiple) voltages and / or (multiple) currents from one or more test zones and / or control zones. At block 1138, the example result determiner 602 processes the result based on the obtained test data (e.g., digital voltage and / or current values ​​marked to the test zone and / or control zone) and the algorithm corresponding to the LFA identifier. Because the machine-readable LFA reader application 117 is capable of scanning different LFA devices, and the algorithm for determining and / or classifying the result based on the obtained data may be different for different devices and / or different diagnostic tests, the LFA reader application 117 determines which algorithm to apply based on the test identifier from the LFA device 104, and uses the obtained test data and the selected algorithm to determine the test result. The algorithm can define a threshold value, which identifies which voltage and / or current values ​​lead to a positive result, and which voltage and / or current values ​​lead to a negative result. In addition, the algorithm can determine how many samples must be positive to produce a positive result (e.g., 5 out of 5 (i.e., all), 4 out of 5 (i.e., percentage), etc.). In some examples, the wireless chip 114 determines the test result at the wireless chip 114. In such an example, the result determiner 602 can display and / or store the obtained result based on the corresponding algorithm. In this way, the result determines that 602 will associate the manufacturing data encoded on the wireless chip 114 (e.g., the ASIC of the wireless chip 114) with the test result without being connected to a secondary system.

[0185] At block 1140, the exemplary result determiner 602 determines whether the result should be displayed on the exemplary user interface 120. For example, for privacy protection, patients may wish to send the result to their doctor instead of showing it to a technician. Therefore, settings can be enabled or disabled depending on whether the result is displayed to protect the privacy of the patient. If the exemplary result determiner 602 determines that the result should not be displayed (e.g., to keep it confidential to the user who implements the test) (block 1140: no), control continues to block 1144. If the exemplary result determiner 602 determines that the result should be displayed (block 1140: yes), the exemplary component interface 600 instructs the user interface 120 to display the result (block 1142). At block 1144, the exemplary result storage 606 stores the result, corresponding information (e.g., device and / or test identification information), and / or context information or supplements (e.g., time, date, patient information, location information, batch number, expiration date, deadline, test information, signal quality information, chain of custody, operator information, etc.). In some examples, the results are tagged to the patient and the corresponding information and / or contextual data is tagged to the results as metadata. Thus, the test data can be immediately associated with the supplemental data set.

[0186] At block 1146, the exemplary component interface 600 sends instructions to the transmitter of the reader 116 to send the results, corresponding information (e.g., device and / or test identification information), and / or context or supplemental information (e.g., time, date, patient information, location information, batch number, expiration date, deadline, test information, signal quality information, chain of custody, operator information, etc.). The exemplary component interface 600 can transmit the results, corresponding information, and / or context or supplemental information to one or more remote databases and / or servers located at or associated with an EMR, government agency, NGO's value proposition, doctor's office, hospital, hospital information system, LIMS system, inventory consumption monitor, clinic and / or other medical institution, medical device manufacturer, medical organization, health information system and / or other external entity via a network. In this way, different actions can be taken based on the receipt of test data. For example, a hospital, doctor's office, manufacturer, agency, etc. can automatically track the usage of an LFA device when it is scanned for reading, automatically reorder additional inventory from a supplier, generate alerts for disease or pathogen outbreaks in a specific area, etc. In some examples, the results and / or other data are automatically uploaded. In some examples, the results and / or other data are uploaded in real time or near real time. In some examples, the reader 116 encrypts information for transmission to an external database and / or server. If the results and corresponding information are sent to a monitoring entity, the monitoring entity can process the results and / or perform statistical analysis based on multiple results received from one or more improved LFA reader applications to determine whether there is a disease outbreak, identify whether the LFA is forged, and the like. In some examples, the result determiner 602 prevents the transmission of duplicate results (e.g., when the device has been marked as being read more than once). If a network connection does not currently exist, the exemplary component interface 600 can delay instructions to the transmitter until a network connection is established. Additionally or alternatively, the exemplary component interface 600 can transmit results from the result storage device 606 periodically, non-periodically and / or based on a trigger (e.g., a result request from a measurement entity).

[0187] Fig.12 is a block diagram of an example processor platform 1200 that is configured to perform Figure 7 Instructions to achieve Figure 4 The machine-readable LFA generator 102 of FIG. 1200 may be, for example, a server, a personal computer, a workstation, a self-learning machine (eg, a neural network), an Internet appliance, or any other type of computing device.

[0188] The processor platform 1200 of the illustrated example includes a processor 1212. The processor 1212 of the illustrated example is hardware. For example, the processor 1212 can be implemented by one or more integrated circuits, logic circuits, microprocessors, GPUs, DSPs, or controllers from any desired series or manufacturer. The hardware processor can be a semiconductor-based (e.g., silicon-based) device. In this example, the processor implements the example user interface 400, the example component generator 402, and the example component applicator 404.

[0189] The processor 1212 of the illustrated example includes a local memory 1213 (e.g., a cache). The processor 1212 of the illustrated example communicates with a main memory including a volatile memory 1214 and a non-volatile memory 1216 via a bus 1218. The volatile memory 1214 may be comprised of a synchronous dynamic random access memory (SDRAM), a dynamic random access memory (DRAM), Dynamic Random Access Memory The non-volatile memory 1216 may be implemented by flash memory and / or any other desired type of memory device. Access to the main memory 1214, 1216 is controlled by a memory controller.

[0190] The processor platform 1200 of the illustrated example also includes an interface circuit 1220. The interface circuit 1220 may be implemented by any type of interface standard, such as an Ethernet interface, a universal serial bus (USB), interface, near field communication (NFC) interface, and / or PCI express interface.

[0191] In the example shown, one or more input devices 1222 are connected to the interface circuit 1220. The input device(s) 1222 allow a user to enter data and / or commands to the processor 1212. The input device(s) may be implemented by, for example, an audio sensor, microphone, camera (still or video), keyboard, buttons, mouse, touch screen, track pad, trackball, isopoint, and / or a voice recognition system.

[0192] One or more output devices 1224 are also connected to the interface circuit 1220 of the illustrated example. The output device 1224 can be implemented, for example, by a display device (e.g., a light emitting diode (LED), an organic light emitting diode (OLED), a liquid crystal display (LCD), a cathode ray tube display (CRT), an in-situ switching (IPS) display, a touch screen, etc.), a tactile output device, a printer, and / or a speaker. Therefore, the interface circuit 1220 of the illustrated example typically includes a graphics driver card, a graphics driver chip, and / or a graphics driver processor.

[0193] The interface circuitry 1220 of the illustrated example also includes communication devices, such as transmitters, receivers, transceivers, modems, residential gateways, wireless access points, and / or network interfaces, to facilitate the exchange of data with external machines (e.g., any kind of computing device) via the network 1226. This communication may be via, for example, an Ethernet connection, a digital subscriber line (DSL) connection, a telephone line connection, a coaxial cable system, a satellite system, a field wireless system, a cellular telephone system, etc.

[0194] The processor platform 1200 of the illustrated example also includes one or more mass storage devices 1228 for storing software and / or data. Examples of such mass storage devices 1228 include floppy disk drives, hard disk drives, compact disk drives, Blu-ray disk drives, redundant array of independent disks (RAID) systems, and digital versatile disk (DVD) drives.

[0195] Figure 7 The machine-executable instructions 1232 may be stored in the mass storage device 1228, in the volatile memory 1214, in the non-volatile memory 1216, and / or on a removable, non-transitory computer-readable storage medium such as a CD or DVD.

[0196] Fig.13 is a block diagram of an example processor platform 1300 configured to perform Figure 8A-10 Instructions to achieve Figure 5 The wireless chip 114. The processor platform 1300 may be, for example, a machine-readable LFA device, a self-learning machine (eg, a neural network), or any other type of computing device.

[0197] The processor platform 1300 of the illustrated example includes a processor 1312. The processor 1312 of the illustrated example is hardware. For example, the processor 1312 can be implemented by one or more integrated circuits, logic circuits, microprocessors, GPUs, DSPs, or controllers from any desired series or manufacturer. The hardware processor can be a semiconductor-based (e.g., silicon-based) device. In this example, the processor implements the example antenna interface 500, the example driver / voltage regulator 502, the example sensor 504, and the example comparator 506.

[0198] The processor 1312 of the illustrated example includes a local memory 1313 (e.g., cache). The processor 1312 of the illustrated example communicates with a main memory including a volatile memory 1314 and a non-volatile memory 1316 via a bus 1318. The volatile memory 1314 may be composed of SDRAM, DRAM, The non-volatile memory 1316 may be implemented by flash memory and / or any other desired type of memory device. Access to the main memory 1314, 1316 is controlled by a memory controller. The example local memory 1313 implements the result storage 508.

[0199] The processor platform 1300 of the illustrated example also includes an interface circuit 1320. The interface circuit 1320 can be implemented by any type of interface standard, such as an Ethernet interface, a USB, interface, NFC interface and / or PCI express interface.

[0200] In the example shown, one or more input devices 1322 are connected to the interface circuit 1320. The input device(s) 1322 allow a user to enter data and / or commands to the processor 1312. The input device(s) may be implemented by, for example, an audio sensor, a button, and / or any other type of input device(s).

[0201] One or more output devices 1324 are also connected to the interface circuit 1320 of the illustrated example. The output device 1324 may be implemented, for example, by a display device (e.g., LED, OLED, LCD, CRT display, IPS display, touch screen, etc.) and / or a speaker. Therefore, the interface circuit 1320 of the illustrated example typically includes a graphics driver card, a graphics driver chip, and / or a graphics driver processor.

[0202] The interface circuitry 1320 of the illustrated example also includes communication devices, such as transmitters, receivers, transceivers, modems, residential gateways, wireless access points, and / or network interfaces, to facilitate the exchange of data with external machines (e.g., any kind of computing device) via a network 1326. This communication may be via, for example, an Ethernet connection, a DSL connection, a telephone line connection, a coaxial cable system, a satellite system, a field wireless system, a cellular telephone system, etc.

[0203] The processor platform 1300 of the illustrated example also includes one or more mass storage devices 1328 for storing software and / or data. Examples of such mass storage devices 1328 include floppy disk drives, hard drive drives, compact disk drives, Blu-ray disk drives, RAID systems, and DVD drives.

[0204] Figure 8A-10 The machine-executable instructions 1332 may be stored in the mass storage device 1328, in the volatile memory 1314, in the non-volatile memory 1316, and / or on a removable, non-transitory computer-readable storage medium such as a CD or DVD.

[0205] Fig.14is a block diagram of an example processor platform 1400 that is configured to perform Fig.11A -B to implement the machine-readable LFA reader application 117 of FIG. 3. The processor platform 1400 may be, for example, a personal computer, a workstation, a self-learning machine (e.g., a neural network), a mobile device (e.g., a cellular phone, a smart phone, an iPad, etc.). TM tablet computer), personal digital assistant (PDA), personal video recorder, or any other type of computing device.

[0206] The processor platform 1400 of the illustrated example includes a processor 1412. The processor 1412 of the illustrated example is hardware. For example, the processor 1412 can be implemented by one or more integrated circuits, logic circuits, microprocessors, GPUs, DSPs, or controllers from any desired series or manufacturer. The hardware processor can be a semiconductor-based (e.g., silicon-based) device. In this example, the processor implements the example component interface 600 and the example result determiner 602.

[0207] The processor 1412 of the illustrated example includes a local memory 1413 (e.g., cache). The processor 1412 of the illustrated example communicates with a main memory including a volatile memory 1414 and a non-volatile memory 1416 via a bus 1418. The volatile memory 1414 may be composed of SDRAM, DRAM, The example local memory 1413 implements the example test type storage 604 and the example result storage 606.

[0208] The processor platform 1400 of the illustrated example also includes an interface circuit 1420. The interface circuit 1420 may be implemented by any type of interface standard, such as an Ethernet interface, a USB, interface, NFC interface and / or PCI express interface.

[0209] In the example shown, one or more input devices 1422 are connected to the interface circuit 1420. The input device(s) 1422 allow a user to enter data and / or commands to the processor 1412. The input device(s) may be implemented by, for example, an audio sensor, microphone, camera (still or video), keyboard, buttons, mouse, touch screen, track pad, trackball, isopoint, and / or a voice recognition system.

[0210] One or more output devices 1424 are also connected to the interface circuit 1420 of the illustrated example. The output device 1424 may be implemented, for example, by a display device (e.g., LED, OLED, LCD, CRT display, IPS display, touch screen, etc.), a tactile output device, a printer, and / or a speaker. Therefore, the interface circuit 1420 of the illustrated example typically includes a graphics driver card, a graphics driver chip, and / or a graphics driver processor.

[0211] The interface circuitry 1420 of the illustrated example also includes communication devices, such as transmitters, receivers, transceivers, modems, residential gateways, wireless access points, and / or network interfaces, to facilitate the exchange of data with external machines (e.g., any kind of computing device) via a network 1426. This communication may be via, for example, an Ethernet connection, a DSL connection, a telephone line connection, a coaxial cable system, a satellite system, a field wireless system, a cellular telephone system, etc.

[0212] The processor platform 1400 of the illustrated example also includes one or more mass storage devices 1428 for storing software and / or data. Examples of such mass storage devices 1428 include floppy disk drives, hard drive drives, compact disk drives, Blu-ray disk drives, RAID systems, and DVD drives.

[0213] Fig.11A -B's machine-executable instructions 1432 may be stored in the mass storage device 1428, in the volatile memory 1414, in the non-volatile memory 1416, and / or on a removable, non-transitory computer-readable storage medium such as a CD or DVD.

[0214] Fig.15 The method for distributing such Fig.14 1432 of the example computer readable instructions 1432 of the example software distribution platform 1505. The example software distribution platform 1505 can be implemented by any computer server, data facility, cloud service, etc., which is capable of storing software and transferring it to other computing devices. The third party can be a customer of the entity that owns and / or operates the software distribution platform. For example, the entity that owns and / or operates the software distribution platform can be such as Fig.14 The third party may be a consumer, user, retailer, OEM, etc., who purchases and / or licenses the software for use and / or resale and / or sublicense. In the example shown, the software distribution platform 1505 includes one or more servers and one or more storage devices. The storage device stores computer readable instructions 1432, which may correspond to the above-described Fig.11AThe example computer readable instructions 1100 of 11B and / or 11B. One or more servers of the example software distribution platform 1505 communicate with a network 1510, which may correspond to any one or more of the Internet and / or any of the above-described example networks. In some examples, one or more servers respond to a request to transfer software to a requesting party as part of a commercial transaction. Payment for the delivery, sale, and / or license of the software may be processed by one or more servers of the software distribution platform and / or via a third-party payment entity. The server enables a purchaser and / or licensee to download computer readable instructions 1432 from the software distribution platform 1505. For example, it may correspond to Fig.11A 1 and / or 6. In some examples, one or more servers of the software distribution platform 1505 periodically provide, transmit and / or force software updates (e.g., Fig.14 Example computer readable instructions 1432) to ensure that improvements, patches, updates, etc. are distributed and applied to the software at the end user device.

[0215] Disclosed herein are example methods, apparatus, systems, and articles of manufacture for manufacturing and / or processing diagnostic test devices. Further examples and combinations thereof include the following: Example 1 includes a lateral flow assay device, comprising: a porous medium, the porous medium comprising a first zone and a second zone, the first zone comprising an immobilized antigen corresponding to a target analyte or an immobilized antibody corresponding to a target analyte; a wireless chip, which wirelessly obtains a first voltage through a signal from an external device, outputs a second voltage less than the first voltage to a first electrode in contact with at least one of the first zone or the second zone, and measures an electrical signal from the first electrode, the electrical signal corresponding to the presence of the target analyte.

[0216] Example 2 includes the lateral flow assay device of Example 1, wherein the signal is an electromagnetic signal, and the first voltage corresponds to a current generated at the antenna when the electromagnetic signal is within a threshold distance to the external device.

[0217] Example 3 includes the lateral flow assay device of Example 1, wherein the wireless chip is used to output a second voltage to assist a reaction at the porous medium, the reaction causing the electrical signal.

[0218] Example 4 includes the lateral flow assay device of Example 1, wherein the electrical signal is at least one of a voltage or a current.

[0219] Example 5 includes the lateral flow assay device of Example 1, wherein the wireless chip is used to transmit data to an external device based on electrical signals.

[0220] Example 6 includes the lateral flow assay device of Example 1, wherein outputting the second voltage increases at least one of an increased current amplitude or a sensitivity of the electrical signal.

[0221] Example 7 includes the lateral flow assay device of Example 1, wherein the first voltage is used to power the wireless chip.

[0222] Example 8 includes a battery-free lateral flow assay device comprising: a porous medium comprising a first zone and a second zone, the first zone comprising an immobilized antigen corresponding to a target analyte or an immobilized antibody corresponding to a target analyte: a wireless chip for outputting a voltage to the first electrode when the first electrode contacts at least one of the first zone or the second zone, the voltage being drawn from a power signal obtained via an antenna, and measuring an electrical signal from the first electrode, the electrical signal corresponding to the presence of the target analyte.

[0223] Example 9 includes the battery-free lateral flow assay device of Example 8, wherein the power signal is an electromagnetic signal, and the power signal corresponds to a current generated at the antenna when the electromagnetic signal is within a threshold distance to an external device that generates the electromagnetic signal.

[0224] Example 10 includes the battery-free lateral flow assay device of Example 8, wherein the wireless chip is used to output a voltage to assist a reaction at the porous medium, the reaction generating an electrical signal.

[0225] Example 11 includes the battery-free lateral flow assay device of Example 8, wherein the electrical signal is at least one of a voltage or a current.

[0226] Example 12 includes the battery-free lateral flow assay device of Example 8, wherein the wireless chip is used to transmit data to an external device based on electrical signals.

[0227] Example 13 includes the battery-free lateral flow assay device of Example 8, wherein the output voltage increases at least one of an increased current amplitude or a sensitivity of the electrical signal.

[0228] Example 14 includes the battery-free lateral flow assay device of Example 8, wherein the power signal is used to power the wireless chip.

[0229] Example 15 includes a lateral flow assay device comprising: a porous medium comprising a first zone and a second zone, the first zone comprising an immobilized antigen corresponding to a target analyte or an immobilized antibody corresponding to a target analyte; a first electrode positionable in the first zone and a second electrode positionable in the second zone; an antenna in a circuit together with the first electrode and the second electrode, the antenna being used to receive a power signal from an external device; a voltage regulator for adjusting a first voltage corresponding to the power signal to a second voltage different from the first voltage and outputting the second voltage to at least one of the first electrode or the second electrode; and a processor circuit for sensing an electrical signal corresponding to at least one of the first electrode or the second electrode, the electrical signal corresponding to the presence of the target analyte.

[0230] Example 16 includes the lateral flow assay device of Example 15, wherein the power signal is an electromagnetic signal, the power signal corresponding to a current generated at the antenna when the electromagnetic signal is within a threshold distance to the external device.

[0231] Example 17 includes the lateral flow assay device of Example 15, wherein the voltage regulator is used to output a second voltage to assist a reaction at the porous medium, the reaction causing the electrical signal.

[0232] Example 18 includes the lateral flow assay device of Example 15, wherein the electrical signal is at least one of a voltage or a current.

[0233] Example 19 includes the lateral flow assay device of Example 15, wherein the antenna is used to transmit data based on the electrical signal to an external device.

[0234] Example 20 includes the lateral flow assay device of Example 15, wherein outputting the second voltage increases at least one of an increased current amplitude or a sensitivity of the electrical signal.

[0235] Example 21 includes the lateral flow assay device of Example 15, wherein the power signal is used to power a processor circuit.

[0236] Example 22 includes a lateral flow assay device comprising: an antenna for generating a first voltage based on an electromagnetic field generated by a reader; a voltage regulator for (A) reducing the first voltage to a second voltage and (B) applying the second voltage to an electrode when the electrode is in contact with a porous medium; and a processor circuit for determining the presence of a target analyte based on a signal corresponding to the electrode.

[0237] Example 23 includes the lateral flow assay device of Example 22, wherein the antenna is used to generate a first voltage when the reader is within a threshold distance of the lateral flow assay device.

[0238] Example 24 includes the lateral flow assay device of Example 22, wherein the voltage regulator is used to output a second voltage to facilitate a reaction at the porous medium, the reaction generating a signal corresponding to the electrode.

[0239] Example 25 includes the lateral flow assay device of Example 22, wherein the signal corresponding to the electrode is at least one of a voltage or a current.

[0240] Example 26 includes the lateral flow assay device of Example 22, wherein the antenna is used to transmit signal-based data to a reader.

[0241] Example 27 includes the lateral flow assay device of Example 22, wherein outputting the second voltage increases at least one of an increased current amplitude or a sensitivity of the signal.

[0242] Example 28 includes the lateral flow assay device of Example 22, wherein the first voltage is used to power the processor circuit. The disclosed methods, apparatus, and articles improve the efficiency of determining the results of a machine-readable diagnostic test. In order to reduce and / or otherwise eliminate ambient light problems, the examples disclosed herein provide machine-readable diagnostics that can be read with a smart phone instead of visual reading. Therefore, the disclosed methods, apparatus, and articles are accordingly directed to one or more improvements in the functionality of diagnostic tests and diagnostic readers.

[0243] In addition, as described above, the visual interpretation of test results is susceptible to operator subjectivity and error. More accurate and objective results can be obtained using the electrical-based examples disclosed herein. The examples disclosed herein include LFA devices that use various technologies (e.g., bioelectrochemical battery technology, circuit completion technology, etc.) to generate electrical signals (e.g., current, voltage, etc.) corresponding to test results. The electrical signals can be measured and provided wirelessly to the reader without including a battery device in the LFA device. In some examples, the LFA device can determine the test results based on the electrical signals and transmit the results to the reader. The reader can obtain the test results and / or process the electrical signals to determine the test results, and distribute the test results to an external server or database (e.g., via a reader) to provide near real-time data corresponding to the disease and / or disease spread.

[0244] In addition, examples disclosed herein provide mechanisms for blocking flow and / or positioning electrodes on the LFA device to obtain a stronger electrical signal that can be measured over a longer duration than other diagnostic tests. Examples disclosed herein also implement multiplexing, where multiple lines can be used to detect multiple markers (e.g., multiple types of antibodies / antigens) based on a sample that are difficult or impossible for the human eye to discern. For example, multiplexing can be applied to a single diagnostic test that can test for multiple types of STDs.

[0245] The example controls disclosed herein also control the timing of the running of diagnostic tests to ensure that an operator does not attempt to obtain results too early (i.e., before the test is complete), obtain results too late, stop flow too early, stop flow too late, etc. This provides further error-proofing for obtaining accurate test results. In addition, the example controls facilitate multiple scans to (a) identify the LFA device, (b) verify that the test being read corresponds to the test that should be read (e.g., when multiple tests are performed on different LFAs in parallel using a single reader), and (c) obtain electrical signals corresponding to the test results. This provides further error-proofing when obtaining multiple tests with overlapping read windows to ensure that the wrong test is not read.

[0246] The examples disclosed herein also include additional information along with the test results (batch number, expiration date, cut-off date, test information, signal quality information, chain of custody, etc.), which can all be transmitted together via NFC technology. Conventional methods use an additional reader, such as, for example, a barcode reader, in addition to the optical reader that determines / interprets the test results, to read information about the test. Thus, the disclosed examples reduce the number of readers required to obtain a greater amount of information.

[0247] Additionally, example rapid diagnostic tests using electronically based methods have higher sensitivity than traditional visual read tests. In examples disclosed herein, using electronically based techniques, lower detection thresholds are possible than can be employed when results are based on visual interpretation by an operator.

[0248] Examples disclosed herein may include NFC chips that may be encoded and encrypted. If adjustments are made to the product tag data, including, for example, extending the shelf life and / or if other improvements are required, the relevant test and manufacturing specific data may then be re-encoded. In some examples, the encoding and / or encryption may be remotely updated and / or configured.

[0249] The example control disclosed herein also applies a potential (e.g., voltage, equilibrium potential, etc.) to an electrode in contact with the porous medium of the lateral flow assay. Applying a potential and / or voltage helps, promotes, and / or creates a more ideal environment for bioelectrochemical reactions to occur. In this way, applying a potential and / or voltage increases the robustness and sensitivity of the signal. In some examples, the examples disclosed herein utilize a voltage (e.g., corresponding to an electromagnetic field obtained via an antenna) for powering a wireless chip, rather than using a conventional battery to apply a potential and / or voltage. In this way, no battery is needed to power the wireless device and / or apply a potential and / or voltage.

[0250] Descriptors "first," "second," "third," etc., are used herein when identifying multiple elements or components that may be referred to individually. Unless otherwise specified or understood based on the context of their use, these descriptors are not intended to confer any meaning of priority, physical order or arrangement in a list, or chronological order, but are merely used as labels to refer to multiple elements or components, respectively, to facilitate understanding of the disclosed examples. In some examples, the descriptor "first" may be used to refer to an element in the detailed description, while the same element may be referred to by a different descriptor in the claims, such as "second" or "third." In this case, it should be understood that such descriptors are used only for the convenience of referencing multiple elements or components.

[0251] "Include" and "comprising" (and all forms and tenses thereof) are used herein as open-ended terms. Thus, whenever a claim uses any form of "include" or "comprising" (e.g., comprises, includes, comprising, including, having, etc.) as a preamble or in any type of claim recitation, it should be understood that additional elements, terms, etc. may be present without exceeding the scope of the corresponding claim or recitation. As used herein, when the phrase "at least" is used as a transitional term, such as in the preamble of a claim, it is open-ended in the same manner as the terms "include" and "comprising" are open-ended. The term "and / or" when used, for example, in a form such as A, B, and / or C, refers to any combination or subset of A, B, and C, such as (1) A alone, (2) B alone, (3) C alone, (4) A and B, (5) A and C, (6) B and C, and (7) A and B and C. As used herein in the context of describing structures, components, items, objects, and / or things, the phrase “at least one of A and B” is intended to refer to embodiments that include any of the following: (1) at least one A, (2) at least one B, and (3) at least one A and at least one B. Similarly, as used herein in the context of describing structures, components, items, objects, and / or things, the phrase “at least one of A or B” is intended to refer to embodiments that include any of the following: (1) at least one A, (2) at least one B, and (3) at least one A and at least one B. As used herein in the context of describing the performance or execution of processes, instructions, actions, activities, and / or steps, the phrase “at least one of A and B” is intended to refer to embodiments that include any of the following: (1) at least one A, (2) at least one B, and (3) at least one A and at least one B. Similarly, as used herein in the context of describing the implementation or execution of a process, instruction, action, activity, and / or step, the phrase "at least one of A or B" is intended to refer to an implementation that includes any of the following: (1) at least one A, (2) at least one B, and (3) at least one A and at least one B.

[0252] As used herein, singular references (e.g., "a," "an," "first," "second," etc.) do not exclude the plural. The term "a" or "an" entity used herein refers to one or more of the entity. The terms "a" (or "an"), "one or more," and "at least one" may be used interchangeably herein. In addition, although listed separately, multiple devices, elements, or method actions may be implemented by, for example, a single unit or processor. In addition, although individual features may be included in different examples or claims, these features may be combined, and inclusion in different examples or claims does not mean that the combination of features is not feasible and / or disadvantageous.

[0253] The following claims are hereby incorporated into the Detailed Description by reference, with each claim standing on its own as a separate embodiment of the present disclosure.

Claims

1. A lateral flow assay device comprising: The porous medium comprises a first region and a second region, the first region comprising an immobilized antigen corresponding to the target analyte or an immobilized antibody corresponding to the target analyte; Wireless chips for: wirelessly obtaining a first voltage via a signal from an external device; outputting a second voltage lower than the first voltage to the first electrode in contact with at least one of the first region or the second region; and An electrical signal from the first electrode is measured, the electrical signal corresponding to the presence of the target analyte.

2. A lateral flow assay device according to claim 1, wherein the signal is an electromagnetic signal and the first voltage corresponds to a current generated at the antenna when the electromagnetic signal is within a threshold distance to the external device.

3. The lateral flow assay device of claim 1, wherein the wireless chip is used to output the second voltage to assist a reaction at the porous medium, the reaction causing the electrical signal.

4. A lateral flow assay device according to claim 1, wherein the electrical signal is at least one of a voltage or a current.

5. A lateral flow assay device according to claim 1, wherein the wireless chip is used to transmit data based on the electrical signal to the external device.

6. The lateral flow assay device of claim 1, wherein outputting the second voltage increases at least one of an increased current amplitude or a sensitivity of the electrical signal.

7. A lateral flow assay device according to claim 1, wherein the first voltage is used to power the wireless chip.

8. A battery-free lateral flow assay device comprising: The porous medium comprises a first region and a second region, the first region comprising an immobilized antigen corresponding to the target analyte or an immobilized antibody corresponding to the target analyte; Wireless chips for: When the first electrode contacts at least one of the first region or the second region, outputting a voltage to the first electrode, the voltage being drawn from a power signal obtained via the antenna; as well as An electrical signal from the first electrode is measured, the electrical signal corresponding to the presence of the target analyte.

9. A battery-free lateral flow assay device according to claim 8, wherein the power signal is an electromagnetic signal, and the power signal corresponds to the current generated at the antenna when the electromagnetic signal is within a threshold distance from an external device that generates the electromagnetic signal.

10. The battery-free lateral flow assay device of claim 8, wherein the wireless chip is used to output a voltage to assist a reaction at the porous medium, the reaction generating the electrical signal.

11. The battery-free lateral flow assay device of claim 8, wherein the electrical signal is at least one of a voltage or a current.

12. The battery-free lateral flow assay device of claim 8, wherein the wireless chip is used to transmit data based on the electrical signal to an external device.

13. The battery-free lateral flow assay device of claim 8, wherein the output voltage increases at least one of an increased current amplitude or a sensitivity of the electrical signal.

14. The battery-free lateral flow assay device of claim 8, wherein the power signal is used to power the wireless chip.

15. A lateral flow assay device comprising: The porous medium comprises a first region and a second region, the first region comprising an immobilized antigen corresponding to the target analyte or an immobilized antibody corresponding to the target analyte; a first electrode positionable in the first region and a second electrode positionable in the second region; an antenna in circuit with the first electrode and the second electrode, the antenna for receiving a power signal from an external device; Voltage regulators for: adjusting a first voltage corresponding to the power signal to a second voltage different from the first voltage; as well as outputting a second voltage to at least one of the first electrode or the second electrode; as well as A processor circuit is provided for sensing an electrical signal corresponding to at least one of the first electrode or the second electrode, the electrical signal corresponding to the presence of a target analyte.

16. A lateral flow assay device according to claim 15, wherein the power signal is an electromagnetic signal, the power signal corresponding to the current generated at the antenna when the electromagnetic signal is within a threshold distance to the external device.

17. The lateral flow assay device of claim 15, wherein the voltage regulator is configured to output the second voltage to assist a reaction at the porous medium, the reaction causing the electrical signal.

18. The lateral flow assay device of claim 15, wherein the electrical signal is at least one of a voltage or a current.

19. The lateral flow assay device of claim 15, wherein the antenna is used to transmit data based on the electrical signal to the external device.

20. The lateral flow assay device of claim 15, wherein outputting the second voltage increases at least one of an increased current amplitude or a sensitivity of the electrical signal.

21. The lateral flow assay device of claim 15, wherein: The power signal is used to power the processor circuit.

22. A lateral flow assay device comprising: an antenna for generating a first voltage based on an electromagnetic field generated by the reader; a voltage regulator for (A) reducing the first voltage to a second voltage, and (B) applying the second voltage to the electrode when the electrode is in contact with the porous medium; as well as A processor circuit is provided for determining the presence of a target analyte based on the signal corresponding to the electrode.

23. A lateral flow assay device according to claim 22, wherein: The antenna is used to generate the first voltage when the reader is within a threshold distance of the lateral flow assay device.

24. The lateral flow assay device of claim 22, wherein: The voltage regulator is used to output the second voltage to assist a reaction at the porous medium, the reaction generating a signal corresponding to the electrode.

25. The lateral flow assay device of claim 22, wherein the signal corresponding to the electrode is at least one of a voltage or a current.

26. A lateral flow assay device according to claim 22, wherein the antenna is used to transmit data based on the signal to the reader.

27. The lateral flow assay device of claim 22, wherein outputting the second voltage increases at least one of an increased current amplitude or a sensitivity of the signal.

28. The lateral flow assay device of claim 22, wherein the first voltage is used to power the processor circuit.

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