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 diagnostic test devices are disclosed. An example apparatus includes a first portion including an opening; a second portion coupled to the first portion and housing a lateral flow assay strip, the second portion including a first clip portion; and a push button located within the opening of the first portion, the push button movable from a first position to a second position, the push button including a second clip portion for engaging the first clip portion of the second portion when moved into the second position to maintain the push button in the second position.

Description

Cross - Reference to Related Applications

[0001] This patent claims the benefit of U.S. Provisional Patent Application No. 63 / 401,073, filed on August 25, 2022, U.S. Provisional Patent Application No. 63 / 401,075, filed on August 25, 2022, and U.S. Provisional Patent Application No. 63 / 432,924, filed on December 15, 2022. U.S. Provisional Patent Application No. 63 / 401,073, U.S. Provisional Patent Application No. 63 / 401,075, and U.S. Provisional Patent Application No. 63 / 432,924 are hereby incorporated by reference in their entireties. The priority of U.S. Provisional Patent Application No. 63 / 401,073, U.S. Provisional Patent Application No. 63 / 401,075, and U.S. Provisional Patent Application No. 63 / 432,924 is hereby claimed. Additionally, U.S. Patent Application No. 17 / 928,188 and U.S. Patent Application No. 17 / 927,648 are hereby incorporated by reference in their entireties. Technical Field

[0002] The present disclosure generally relates to biosensors, and more particularly, to machine - readable diagnostic test devices and methods and apparatuses for manufacturing and / or processing such devices. 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 disorder, disease, analyte, 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.). LFAs have been used to detect the presence of a target analyte to determine pregnancy, the presence of HIV, the presence of the novel coronavirus, the presence of Ebola, the presence of different toxins, etc. Brief Description of the Drawings

[0004] Figure 1A is an example environment that includes an example machine - readable lateral flow immunoassay generator to generate a machine - readable lateral flow immunoassay described in conjunction with the examples disclosed herein.

[0005] Figure 1B is Figure 1A a side view of an example machine - readable lateral flow immunoassay of

[0006] Figure 2A Illustration Figure 1A a top view of an example implementation of the machine - readable lateral flow immunoassay of

[0007] Figure 2B Illustration Figure 2A a side view of the machine - readable lateral flow immunoassay of

[0008] Figure 2CIllustration of an example conjugate of immobilized antigen and / or antibody on the test line of a machine-readable lateral flow immunoassay attachable to Figures 1A to 2B

[0009] Figures 2D to 2F Illustration of an example implementation of a front-end channel usable in a machine-readable lateral flow immunoassay from FIGS. 1 to Figure 2D

[0010] Figure 2G Illustration of an example housing of an example LFA device in a first position Figure 1A

[0011] Figure 2H Illustration of an example housing of an LFA device in a second position Figure 1A

[0012] Figure 2I Illustration of Figure 2G and Figure 2H exploded view of an example housing

[0013] Figure 2J Illustration of a top view above a cross-section of a housing along line A-A of Figure 2G rotated

[0014] Figure 2K Illustration of an example housing of an example LFA device in a first position Figure 1A

[0015] Figure 2L Illustration of an example housing of an LFA device in a second position Figure 1A

[0016] Figure 2M Illustration of Figure 2K and Figure 2L exploded view of an example housing

[0017] Figure 2N Illustration of a top view above a cross-section taken along line B-B of Figure 2K

[0018] Figure 2O Illustration of Figure 2K and Figure 2L two partial cross-sectional views of an example housing, with the slider in a first position and a second position Figure 2O The top and bottom views in Figure 2K are cross-sections taken along line C-C and rotated 180 degrees horizontally.

[0019] Figure 2P Illustration of the operation of a lateral flow assay device incorporating a holding compartment and Figures 1A to 2D and / or Figures 2K to 2O ​​​​​​​​

[0020] Figure 2Q Diagrams of alternative operations of a lateral flow assay device incorporating and / or Figures 1A to 2D and / or Figures 2K to 2O maintaining compartments.

[0021] Figure 3 is Figure 1A a block diagram of an example implementation of a machine-readable lateral flow immunoassay generator.

[0022] Figures 4 to 5 The diagram represents a flowchart of example machine-readable instructions that may be executed to implement Figure 1A and / or Figure 3 a machine-readable lateral flow immunoassay generator.

[0023] Figure 6 is a block diagram of an example processing platform structured to execute Figures 4 to 5 instructions to implement Figure 1A and / or Figure 3 a lateral flow immunoassay generator.

[0024] Figure 7 is a block diagram of an example software distribution platform for distributing software (e.g., software corresponding to Figures 3 to 4 example computer-readable instructions) to client devices such as consumers (e.g., for licensing, selling, and / or using), retailers (e.g., for selling, reselling, licensing, and / or sublicensing), and / or original equipment manufacturers (OEMs) (e.g., for inclusion in products to be distributed to, e.g., retailers and / or direct purchase customers).

[0025] The accompanying drawings are not drawn to scale. Instead, the thickness of layers or regions may be exaggerated 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., a layer, film, area, region or plate) is on another part in any way (e.g., positioned on, located on, disposed on or formed on another part, etc.) indicates that the part being referenced is in contact with the other part, or that the part being referenced is above the other part with one or more intervening parts therebetween. Connection references (e.g., attaching, coupling, connecting and joining) are to be construed broadly and may include intermediate members between a series of elements and relative movement between the elements, unless otherwise stated. Accordingly, a connection reference does not necessarily infer that two elements are directly connected and in a fixed relationship with each other. Stating that any part is "in contact with" another part means that there is no intervening part between the two parts. Although the drawings show layers and regions as having clear lines and boundaries, some or all of these lines and / or boundaries may be idealized. In reality, the boundary and / or line may be unobservable, blended and / or irregular. Detailed Description

[0026] A rapid diagnostic test includes a biosensor or test strip device (e.g., a lateral flow immunoassay (LFA)), which is a device including a first section for obtaining a sample (e.g., blood, urine, saliva, nasal mucus, 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 disorder is present in the sample. For example, a user applies the sample to a sample pad of the test strip device or simply a "test strip" (e.g., an LFA, etc.). Once applied, the sample migrates along the test strip to a conjugate pad containing a conjugate (e.g., a detectable label, tag, linker, antibody, antigen, etc.) specific for the target analyte. If the sample includes the target analyte, a reaction (e.g., a chemical reaction, biochemical reaction, physical reaction, etc.) will occur on the conjugate pad to bind the target analyte to the conjugate. The test strip also includes a test line that contains molecules (e.g., immobilized antigens, antibodies, analytes, aptamers, etc.) specific for the target analyte, which bind a first set of conjugate molecules (e.g., probe molecules) from the conjugate pad. For example, if the analyte of interest is an antibody, the positive test region includes an immobilized antigen. If the analyte of interest is an antigen, the positive test region includes an immobilized antibody. The labeled substance or conjugate includes a first binding component capable of binding the analyte of interest and, in some examples, a second visualization component. Thus, when the sample (e.g., including the bound target analyte) flows to the test region (e.g., the reaction region), the antibody, analyte, or antigen of the test line binds to the bound target analyte, thereby immobilizing the target analyte. In some test strips, the immobilized target analyte results in a visual output that identifies the presence of the target analyte in the sample. Thus, a scanner or the user can identify whether the target analyte (e.g., corresponding to a disorder or disease) is present in the sample based on the color of the test region.

[0027] "Target analyte", "analyte", or "analyte of interest" refers to a compound or composition detected or measured from a sample that has at least one epitope or binding site. An analyte can be any substance for which there exists a naturally occurring analyte-specific binding member 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 and drugs administered for illegal purposes) and / or metabolites or antibodies of any of the above substances. The term "analyte" also includes any antigenic substance, hapten, antibody, macromolecule, and / or combinations thereof.

[0028] "Label" refers to any substance that can generate a signal detectable by visual and / or instrumental means. The various labels applicable to the examples disclosed herein include labels that generate signals by chemical and / or physical means. Examples include enzymes and substrates, chromogens, fluorescent compounds, chemiluminescent compounds, colored or colorable organic polymer latex particles, liposomes, and / or other vesicles containing directly visible substances. In some examples, radiolabels, colloidal metal particles, and / or colloidal non-metal particles are employed. In some examples, the label includes colloidal gold and latex particles.

[0029] "Labeled substance" or "conjugate" refers to a substance that includes a detectable label attached to a specific binding member. The attachment can be covalent or non-covalent and can include nucleic acid hybridization. The label allows the labeled substance to generate 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 labeled substance is selected to bind the analyte directly or indirectly.

[0030] "Specific binding member" refers to a member of a specific binding pair (e.g., two different molecules, where one of the molecules 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, analyte, antigen, 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 or fragment(s) thereof, and a mixture of an antibody and other specific binding members. Specific examples of specific binding members include biotin and avidin, an antibody and its corresponding antigen (both unrelated to the sample to be assayed), single-stranded nucleic acids and their complementary strands, etc.

[0031] The "test strip" or "LFA" may include one or more absorbent or non-absorbent materials. If the test strip includes more than one material, the one or more materials are preferably in fluid communication. One material of the test strip may cover another material of the test strip, such as, for example, filter paper covering nitrocellulose. Additionally or alternatively, the test strip may include a section containing one or more materials (e.g., a medium), followed by a section containing one or more different materials. In this case, the sections are in fluid communication and may or may not partially overlap each other. 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, as well as materials made of glass fiber, nylon, polyester, polyvinyl chloride (PVC), polyacrylamide, Sephadex, agarose, polyacrylate, ceramic materials, etc. One or more materials of the test strip may optionally be treated to alter their capillary flow characteristics or the characteristics of the applied sample. For example, the sample application section of the test strip may be treated with a buffer to correct the pH or specific gravity of the applied urine sample to ensure optimal test conditions.

[0032] The one or more materials may be a single structure, such as a sheet cut into strips, or it may be several strips or particulate materials bonded to a support or solid surface, such as, for example, found in thin layer chromatography, and may have an absorbent pad as an integral part or in contact with the liquid. The material may also be a sheet having reaction lanes thereon, capable of spotting to induce the formation of reaction lanes, where individual assays may be performed in each reaction lane. The material may have a rectangular, circular, oval, triangular, or other shape, provided that there is at least one transverse direction for the test solution by capillary migration. Other transverse directions may occur, such as in an oval or circular piece in contact with the test solution at the center. However, the main consideration is the presence of at least one flow direction to a pre-determined point. In the following discussion, the test strip will be described by way of illustration and not limitation.

[0033] In cases where a support is desired or required, the support of the test strip will typically be water-insoluble, often non-porous and rigid, but may be elastic, typically hydrophobic and porous, and will generally have the same length and width as the strip, but may be larger or smaller. The support material may be transparent, and when assembling the test device disclosed herein, the transparent support material may be on the side of the test strip that can be observed by the user, such that the transparent support material forms a protective layer on the test strip, where the transparent support material may be exposed to the external environment, such as through an aperture in front of the test device. A wide variety of natural and synthetic movable and immovable materials, and combinations thereof, may be employed, provided that the support does not interfere with the capillary action of one or more materials, or non-specific binding of assay components, or interfere with the signal generation system. Illustrative polymers include polyethylene, polypropylene, poly(4-methyl-1-butene), polystyrene, polymethacrylate, poly(ethylene terephthalate), nylon, poly(vinyl butyrate), glass, ceramics, metals, etc. Elastic supports may be made of polyurethane, neoprene, latex, silicone rubber, etc. Throughout this description, LFAs are described, and it is understood that the description of LFAs applies to other types of test strips.

[0034] In some conventional LFAs, test results are manifested as faint color changes, which leads to an increase in user errors during reading. For example, although an LFA may output a color corresponding to a positive result, if the color is faint and / or the lighting conditions are poor, the user may interpret the test as negative. Additionally, since some conventional LFAs rely on visual cues to determine the result, the test lines corresponding to the result need to be sufficiently spaced and / or sufficiently restricted to avoid confusion or reading errors. The examples disclosed herein generate machine-readable LFAs to provide objective and automated result generation through algorithms that reduce and / or otherwise eliminate false positives and / or false negatives due to human error. Additionally, using LFAs that do not rely on visual cues allows more test zones to be placed closer together without the risk of misinterpreting visual results.

[0035] The examples disclosed herein provide LFAs that can be read using a smartphone application (e.g., directly or via a dedicated reader). Although some smartphone applications may be able to read the results of LFA-based tests, such smartphone applications may output inaccurate results due to poor lighting conditions, LFAs with weak visual indicators, and / or poor-quality sensors on the smartphone.

[0036] The examples disclosed herein generate LFAs to address conventional smartphone application errors and / or human errors corresponding to inaccurate results of conventional 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 test results, one or more digital current and / or voltage values corresponding to test results, one or more logic values corresponding to 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 conventional visual indicators to determine the results of a test based on a fluid sample (e.g., an LFA-based test). In the examples disclosed herein, the LFA provides machine-readable results to a smartphone application. As a result, 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 include a reading window, etc. for visual reading of the results of the LFA device. As further disclosed herein, the example LFA device does not need to house a battery (e.g., a device for storing energy). For example, the LFA device is battery-free, not connected to a power source by wires, and powered by an electromagnetic field generated by a user device such as a reader. Additionally, accurate results can be easily transmitted to an external database and / or an external server, such as a remote database and / or server located at or otherwise associated with an electronic medical record (EMR), a government agency, a non-governmental organization (NGO), a doctor's office, a hospital, a hospital information system, a laboratory information management software (LIMS) system, an inventory consumption monitor, a clinic, and / or other medical facilities, a medical device manufacturer, a medical organization, a health information system, and / or other external entities. In this way, large-scale test results can be digitally generated, collected, and integrated into other healthcare systems to eliminate human-based transcription errors. The examples disclosed herein are also capable of enabling self-testing, including, for example, testing performed by non-medical personnel, since untrained self-testers do not require knowledge of how to interpret the results. Self-testing can be incorporated into over-the-counter or consumer devices. The examples disclosed herein can be incorporated into disposable point-of-care devices.

[0037] Examples disclosed herein include LFA devices that include a wireless chip for obtaining data corresponding to the presence or absence of an analyte in a sample based on electrical signals generated on the LFA device and transmitting the data to a reader. Determination of test results is based on comparison of the electrical signals to one or more thresholds. The comparison can be made on the wireless chip of the LFA and / or at 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 values to one or more thresholds to determine whether the test result is positive or negative. For example, if the current and / or voltage values are above the threshold, the reader determines that the test corresponding to the current and / or voltage values is positive. Similarly, if the current and / or voltage values are below the threshold, the reader determines that the test corresponding to the current and / or voltage values is negative. In some examples, the wireless chip obtains analog current and / or voltage values, converts the analog values to digital values, and transmits the digital values to the reader. In this way, the reader can compare the 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 value (e.g., with or without conversion to a digital value) to one or more thresholds to generate a logic value (e.g., high or low) corresponding to a positive or negative test and transmits the test result to the reader.

[0038] Examples disclosed herein include various techniques for generating electrical signals on an LFA device that indicate the presence or absence of an analyte of interest. For example, to obtain one or more electrical signals corresponding to one or more test results, examples disclosed herein can utilize a bioelectrochemical mechanism (e.g., a device that generates energy) at a test line and / or a control line of the LFA device. As described further below, the bioelectrochemical mechanism includes a bioelectrochemical cell (e.g., a structured porous membrane that acts as a physical battery) that generates an electrical signal at the porous membrane when the target analyte is present. The bioelectrochemical cell can be referred to as otherwise including a potentiometric 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 electrodes of the bioelectrochemical cell corresponding to the porous membrane.

[0039] In some examples of the bioelectrochemical cells disclosed herein, the bioelectrochemical cell is attached to a test region (e.g., a test line, a test region portion, etc.) and / or a control region (control line) of a porous medium (e.g., a membrane, paper, and / or other non-compartmental or non-chambered substrate) of an LFA. In some examples, the bioelectrochemical cell can be a sheet of paper that has been impregnated with a solution of glucose and a redox substance (e.g., potassium ferricyanide K3[Fe(CN)6] 3- or ferrocene or a ferrocene derivative) and dried. In some examples, the medium (e.g., a membrane, paper, and / or substrate) of a lateral flow immunoassay device can act as a bioelectrochemical cell, as further described below. Additionally, in the examples disclosed herein, an enzyme (e.g., glucose oxidase (GOx)) is labeled (e.g., attached, conjugated, etc.) to an antibody analyte and / or antigen on a conjugate pad. In this way, if the antibody analyte and / or antigen conjugated to GOx attaches to a target analyte, the immobilized antibody, analyte, and / or antigen corresponding to the target analyte at the test region attaches and immobilizes GOx. Since half of the bioelectrochemical cell is attached to the test region, GOx reacts with the solution of the bioelectrochemical cell to oxidize the glucose of the bioelectrochemical cell, as shown in Chemical Reaction Processes 1-3 below, where (Ox) and (Red) refer to the reduced or oxidized state of the enzyme, respectively. In some examples (e.g., when the porous medium acts as a bioelectrochemical cell), glucose is introduced as part of a buffer applied by the user. In some examples, glucose is introduced into a holding component (e.g., a blister, a stamping cavity, a bag, a pouch, etc.), as further described below.

[0040] Additionally, Processes 4-5 below illustrate chemical reactions in which the cofactors flavin adenine dinucleotide (FAD) and FADH2 refer to the oxidized or reduced state of the enzyme active center, respectively.

[0041] Although the examples disclosed herein refer to GOx as the enzyme used to generate products corresponding to current flow and / or release / movement of 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 oxidase, nicotinamide adenine dinucleotide phosphate (NADPH) oxidase, alcohol oxidase, galactose oxidase, and / or any other oxidase as the enzyme used to generate products that facilitate the release and / or movement of electrons (e.g., hydrogen peroxide). In some examples, based on the enzyme used, molecules other than glucose are included to facilitate the reaction to generate hydrogen peroxide.

[0042] In some examples, an enzymatic reaction with a native mediator (electron acceptor) (e.g., oxygen) can be used in a bioelectrochemical cell. In such examples, 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 cause the reaction of C6H 12 O6 and oxygen (O2) and generate C6H 10 O6 and H2O2 (e.g., hydrogen peroxide). In some examples, the electrode can be made of a metal (e.g., copper, titanium, brass, silver, platinum, etc.), graphite, or a screen-printed carbon electrode doped with ferrocyanide. In this way, the product (e.g., H2O2) is reduced, and oxidation of the metal or ferrocyanide of the electrode occurs through the release of electrons. In the latter case, ferrocyanide [Fe(CN)6] 4- reacts to [Fe(CN)6] 3- . 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)). Cu2O is oxidized to CuO (Cu(II)) by the reduction of H2O2.

[0043] In other examples, alternative reactions can be implemented with a bioelectrochemical cell. For example, an amperometric redox reaction without an enzyme can be used in a bioelectrochemical cell. For example, the amperometric signal of LFA can be measured without the GOx enzyme because the gold of AuNP can act as a catalyst (e.g., in the case where 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 Process 11 below, thiosulfate, ferrocyanide, and KBr or KCl react, and AuNP catalyzes the reduction to ferrocyanide to produce an electronic signal. KBr or KCl can be included in the buffer and / or can be dried on a portion of the porous membrane and resuspended with the buffer.

[0044] Alternatively, Processes 9 - 11 below illustrate alternative chemical reactions of GOx - glucose oxidation. As shown in the previous processes, oxygen can reactivate or re - oxidize GOx to its active form. Although Processes 9 - 11 are described in conjunction with ferricyanide, Processes 9 - 11 can be used with other substances in their oxidized form (e.g., quinones, ferrocene, osmium complexes, etc.). Quinones, ferrocene, osmium complexes, etc. can be included in a buffer and / or can be dried on a portion of a porous membrane and resuspended with a buffer.

[0045] Processes 4 and 11 result in a decrease in the pH level of the solution (e.g., to an acidic range in the case of a low - buffer system), which corresponds to the electromotive force with respect to an electrode placed next to the test line of the LFA where no GOx reaction occurs. The change in the pH level will occur in a low - concentration buffer solution and result in a measurable Nernst voltage and / or current.

[0046] In the redox cycle of GOx, electrons can be transferred at one half of the bio - electrochemical cell to reduce [Fe(CN)6] 3- to [Fe(CN)6] 4- . Ferricyanide molecules act as electron mediators and can eventually diffuse to the electrode. The concentration difference between the electrode at the upper part of the cell and the electrode at the bottom part of the cell gives rise to a potential difference described by the Nernst equation and / or The described battery voltage. Thus, when the target analyte is present in the sample, the porous medium combines with the battery and / or the electrodes to generate an electrical signal (e.g., voltage or current). The example measurements disclosed herein correspond to voltages and / or currents from the battery (e.g., from one half to the other half) by measuring the current through the potentiometric cell 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), thus eliminating the need for a visual indicator. When implementing a bioelectrochemical cell, there may be other combinations of elements and / or reducing agents in addition to the examples listed above, which may be used additionally or alternatively. The LFA that takes full advantage of reactions that result in the detection of ions in a solution based on current or charge in the current (e.g., amperometric measurements) is referred to herein as amperometric-based LFA. The LFA that takes full advantage of the detection of the potential difference between two electrodes (e.g., potentiometric measurements generated by redox reactions) is referred to herein as potentiometric-based LFA.

[0047] As described above, the medium (e.g., membrane, paper, and / or substrate) of a lateral flow immunoassay device can act as a bioelectrochemical cell. For example, instead of using paper dried with glucose and a redox substance to act as a bioelectrochemical cell, a liquid assay buffer can be applied to a lateral flow immunoassay device that includes a redox substance, and glucose can be included in a component that releases glucose at and / or near the test line and / or control line at a specific time point. In some examples, the buffer can dilute the sample and include a redox substance to facilitate a reaction that generates current or voltage. In such examples, the membrane of the lateral flow immunoassay device acts as a salt bridge. In this way, if the immobilized antibody analyte and / or antigen corresponding to the target analyte at the test zone attaches and immobilizes GOx, the GOx will react with the glucose released from the component holding the glucose and the redox substance of the assay buffer to diffuse electrons to a region of the medium outside the test zone, thereby generating a voltage and / or current. Thus, the bioelectrochemical cell is based on the test zone and the region outside the test zone. Accordingly, a first electrode can be placed at the test zone, and a second electrode can be placed at a region outside the test zone, and the voltage and / or current between the two test zones can be measured to determine the presence of the target analyte. 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 paired redox reactions. A 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 that includes two half-cells with the same electrodes that generates 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., a cell that includes two different metals immersed in electrolytes connected by a salt bridge or a porous medium), and / or any other cell that converts chemical energy into electricity.

[0048] Because the LFA device can correspond to one or more specific durations for which the user should take a specific action (e.g., the duration of applying the sample and / or buffer, the duration for obtaining a result after applying the sample, the duration for scanning the LFA device with a reader, the duration for moving the mechanical parts of the LFA device, etc.), the examples disclosed herein include mechanisms and processes for tracking time and / or guiding the user to perform one or more steps. For example, after applying the sample and / or buffer to the LFA, the user may need to wait for a first duration before obtaining the result. The examples disclosed herein may include a timer at the LFA device and / or at the reader to track the (multiple) durations for guiding the user through the test process. In some examples, the timer is powered by the current and / or voltage generated by the bioelectrochemical cell. In some examples, the LFA device may transmit timing information to the LFA reader, and the LFA reader may display to the user and / or otherwise indicate one or more durations. In some examples, the LFA reader may track the duration based on confirmation from the user and guide the user when to perform a specific task to ensure that the task is not performed too early or too late (e.g., reading the result 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 users with less training and / or can be performed by users with a lower educational level. Additionally, the reader can be implemented by the patient by following the guidelines presented on the reader for self-testing.

[0049] Figure 1A is an example environment 100 (illustrated in top view) that includes an example machine-readable LFA generator 102 for generating an example machine-readable LFA chip, strip, or LFA device 104. 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, example bioelectrochemical cells 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 for determining the test result (e.g., diagnostic test result) of the sample 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 examples are based on the bioelectrochemical cells 111a-n to determine the test result, Figure 1A they can be described in combination with other techniques for determining the test result based on electrical signals, as further disclosed herein.

[0050] Figure 1A An example machine-readable LFA generator 102 generates an example machine-readable LFA device 104. 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, example bioelectrochemical cells 111a-n, an example wicking pad 112, an example inlet 113, an example wireless chip 114, an example antenna 115, and / or wires or etched circuits included in a housing structure (not shown). The number of tests, the type of tests (e.g., pregnancy, Ebola virus, HIV, influenza, coronavirus, cancer, sexually transmitted disease (STD), novel coronavirus, etc.), the number of control areas, the type of control areas (e.g., positive control, negative control, etc.), and / or the type of machine-readable LFA are based on instructions from the user and / or the manufacturer. For example, if the user desires the example machine-readable LFA device 104 to include a single test for pregnancy, the machine-readable LFA generator 102 generates an example conjugate section to include an antibody, analyte, and / or antigen corresponding to the target analyte corresponding to pregnancy, which is labeled with a specific molecule (e.g., gold nanoparticles, GOx, etc.). In such an example, the machine-readable LFA generator 102 generates the test area 110 to include an immobilized antibody, analyte, and / or antigen that binds to or otherwise attaches to the target analyte. Additionally, the example machine-readable LFA generator 102 generates or otherwise attaches the wireless chip 114 to attach to the bioelectrochemical cell to determine whether the sample (e.g., biological sample) is positive or negative for the target analyte corresponding to pregnancy. Binding Figure 3 An example machine-readable LFA generator 102 is further disclosed.

[0051] Figure 1A The example machine-readable LFA device 104 is a bioelectrochemical cell-based LFA (e.g., a concentration cell with Nernst voltage sensing) that includes example bioelectrochemical cells 111a-n. However, the machine-readable LFA device 104 can be an alternative device that can obtain data related to the test results on the LFA 104. In some examples, the example 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 the user (e.g., because there are no gold nanoparticles on the device) and / or the visual indication may not be visible to the user (e.g., because the housing covers the porous medium where the visual indication can be achieved). In some examples, the LFA device 104 is a visual indication biosensor device that provides a visual indication of the 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 example wireless chip 114).

[0052] Figure 1A An example machine-readable LFA device 104 is a device that includes a sample pad 106 (e.g., sample pad, sample section, sample area, sample zone, etc.). For example, the LFA device 104 can be a porous membrane device, a porous medium device, a fluid delivery medium device, a test strip device, a lateral flow test strip device, and / or any fluid sample device. The sample pad 106 is structured to act as a sponge to hold the sample of the fluid applied to the sample pad 106. In some examples, the sample pad 106 includes buffering components (e.g., salts, surfactants, etc.) to ensure that the target analyte that may be present in the sample can bind to the components of the conjugate release pad 108. When the sample pad 106 is wetted, the fluid held in the sample pad 106 flows to the conjugate release pad 108. The conjugate pad 108 includes a substance or conjugate structured to bind the label of the target analyte. For example, the conjugate release pad 108 includes a conjugate or probe (e.g., an antibody specific for one or more target analytes) labeled with a detectable label, tag, linker, antibody, analyte, antigen, GOx, gold nanoparticles, etc. The target analyte is a component corresponding to a specific disorder or disease. Thus, the presence of the target analyte in the sample corresponds to the presence of the corresponding disorder and / or disease in the patient providing the sample. If the sample includes one or more of the target analytes, the conjugate and / or probe labeled with GOx, gold nanoparticles, etc. attaches to the corresponding target analyte. The sample (e.g., including the probe 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 toward the wicking pad 112.

[0053] When the sample flows through Figure 1AWhen the sample flows through the test area 110 when the medium 109 is present. The medium 109 can be a porous membrane, a nitrocellulose membrane, paper, and / or other substrates (including non-compartmentalized substrates), etc., which facilitate the flow of biological samples and / or liquid buffers. The test area 110 includes a test zone (e.g., a test line, a test area, a test zone portion, etc.) and / or a control zone (e.g., a control line, a control area, a control zone portion, etc.) that is displaced along the longitudinal axis of the medium 109. The test zone includes specifically immobilized antibodies, analytes, or antigens that react with the corresponding target analyte, and the target analyte is attached to the probe and / or conjugate. Thus, when the target analyte corresponding to a specific test zone is present in the sample, GOx and / or gold nanoparticles are immobilized at that specific test zone. In some examples, the test zones of the LFA 104 correspond to different disorders or diseases, which is referred to as multiplexing. Multiplexing includes structuring multiple test zones or test lines to detect multiple markers (e.g., multiple types of antibodies / antigens / analytes or multiple analytes) in a single sample. Multiplexing has applications, for example, in 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 immobilizes specific and / or excess conjugates flowing through the control zone. The control zone corresponds to a target that has been dried onto the porous medium 109 to indicate that the test is ready to be read (e.g., when the test is complete).

[0054] Figure 1A The test area 110 also includes exemplary bioelectrochemical cells 111a-n (e.g., concentration cells). Figure 1A Figure showing a portion of the bioelectrochemical cells 111a-n. In some examples, the potentiometric cells 111a-n are paper sheets or other substrates impregnated with an enzyme substrate (e.g., glucose) and / or a reducing agent (e.g., hydroquinone, aminophenol, ascorbic acid contained in vitamin C, etc.) and / or an electron mediator or redox substance (e.g., potassium ferricyanide, ferrocene, oxygen, ferrocene derivatives, etc.). However, the bioelectrochemical cells 111a-n can be any type of bioelectrochemical cell. For example, the porous membrane 109 can act as one or more bioelectrochemical cells, as described below in connection with Figures 2A to 2BFurther described. When GOx (which oxidizes glucose) or gold nanoparticles (via autocatalytic silver nitrate reduction (e.g., vitamin C and / or another reducing agent)) are attached to the test zone and / or the control zone, the corresponding bioelectrochemical cells 111a-n are activated by generating a voltage according to the Nernst equation, which voltage can be read out via the wireless chip 114. Thus, the wireless chip 114 uses the example bioelectrochemical cells 111a-n to perform bioelectrochemical measurements, where the wireless chip 114 passively measures the potential between two different parts of the biofuel cells 111a-n using two electrodes. In some examples, the bioelectrochemical cells 111a-n are fluidically coupled (e.g., attached) to the test zone and / or the control zone during manufacturing. In some examples, the bioelectrochemical cells 111a-n are separated from the test zone and / or the control zone during manufacturing, and the example LFA device 104 includes mechanical components and / or devices to automatically and / or manually press the bioelectrochemical cells into contact (e.g., fluid contact) with the test zone and / or the control zone when the test is to be performed (e.g., automatically and / or manually via user intervention when a sample is applied to the LFA 104 to press the bioelectrochemical cells into contact with the zones).

[0055] Figure 1A The test zone 110 of also includes an example wicking pad 112. The example wicking pad 112 (also referred to as a waste pad) is 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 backflow. Additionally, in some examples, the wicking pad 112 serves as a waste container. As used herein, downstream is referred to as towards the waste pad 112, and upstream is referred to as towards the sample pad 106.

[0056] The test zone 110 also includes Figure 1A an inlet 113. Figure 1A The example inlet 113 of is structured 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 enclosed in a holding device (e.g., a frangible casing such as a bag), and the user presses and / or moves components of the LFA device 104 to cause the holding 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 water / buffer and / or additional reagents). When water and / or buffer flows through the bioelectrochemical cells 111a-n, if the test zone and / or the control zone have been attached to GOx and / or gold nanoparticles (e.g., based on a mixture of the conjugate with the enzyme substrate, reducing agent, and / or electron mediator of the bioelectrochemical cells 111a-n), the water and / or buffer resuspends the dried reagents to cause current flow. The first part of the bioelectrochemical cells 111a-n (e.g.,Figure 2A The top part of the Figure 2A The center area between the bottom part of Figure 2A The constriction region in the test zone (in the test zone) acts as a uniform salt bridge against the diffusion-induced 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 toward 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.

[0057] Example machine-readable LFA device 104 also includes example wireless chip 114. Wireless chip 114 is a near field communication (NFC) chip. Thus, wireless chip 114 can obtain power and / or communicate with reader 116 via the NFC communication protocol. Alternatively, example wireless chip 114 can be a radio frequency identification (RFID) chip or any other type of wireless chip. Wireless chip 114 includes pins coupled to a connector (e.g., wire, etched circuit, etc.) that is coupled to an electrode (e.g., directly or via a front-end device, as further described below). The electrodes are connected to two ends of each of the bioelectrochemical cells 111a-n and / or on different segments of the porous membrane 109. In this way, if a voltage and / or current is generated by the bioelectrochemical cells 111a-n, the voltage drop and / or current between 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 wireless chip 114 (e.g., to provide power for storing the results of the test at wireless chip 114). 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 a target analyte is present in the sample. Wireless chip 114 can include an ASIC for encoding manufacturing and / or identification information. Example wireless chip 114 is powered by example antenna 115. When example reader 116 generates a magnetic field within a threshold distance to example antenna 115, a current is generated at antenna 115 and the corresponding energy is used to power wireless chip 114. The energy can be used to provide a voltage to power wireless chip 114. In some examples, the voltage is (e.g., 1.8 volts (V)). In other examples, the voltage can have a different magnitude, including e.g., 3.3V, 5V, etc. Once powered on, wireless chip 114 can operate. For example, in operation, wireless chip 114 can apply a potential. In some examples, wireless chip 114 operates to measure voltage, current, and / or resistance, etc. Additionally or alternatively, in some examples, wireless chip 114 operates to transmit identification information (e.g., device identifier, test identifier, serial number, product code, etc.) to example reader 116 and / or can transmit measurement results corresponding to the test results (e.g., analog and / or digital values corresponding to voltage and / or current measurements performed at LFA device 104). In some examples, the communication between wireless chip 114 and reader 116 is encrypted using encryption techniques known to both wireless chip 114 and reader 116. In some examples, wireless chip 114 can determine each test zone and / or control zone as positive or negative based on the measured current, electromotive force, and / or voltage drop. Additionally, in some examples, wireless chip 114 stores the results corresponding to the determination(s), and / or uses antenna 115 to transmit the results.Additionally, the example wireless chip 114 may transmit identification information corresponding to, among other things, the LFA identifier, the test area, and / or the identifier of the control area, along with the results. Although... Figure 1A Examples of Figure 1A include the example wireless chip 114 that is part of the example LFA 104, but the wireless chip may be integrated in an external device. In such an example, the LFA 104 may include components (e.g., an interface) that allow 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 may be connected to the wireless chip 114 to transmit test results to the example reader 116.

[0058] Figure 1A An example reader 116 is a smart phone 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 computer, a personal digital assistant, a laptop computer, a stand-alone LFA reader device, and / or any other processing device that includes the example machine-readable LFA reader application 117, the example antenna 118, and / or the example user interface 120, 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 can be installed, downloaded, and / or encoded within the example reader 116. In some examples, the example machine-readable LFA reader application 117 may be provided via a near-field communication tag or a Bluetooth device.

[0059] In some examples, the reader 116 may be split into multiple readers. In such an example, a first reader 116 obtains information from the LFA 104 and guides the user through the process of the LFA 104, and a second reader 116 obtains the test results from the LFA 104. For example, in a hospital, a hospital information system, a LIMS system, an inventory consumption monitor, a clinic, a test site, etc., the first reader may guide a first user to obtain a sample using a first LFA reader. Once the sample is obtained, the first reader may communicate with the second reader to send LFA device information and start a timer at the second reader to wait for the test to be ready. In this way, the first user may provide the LFA device to the second user, and the second user may scan the LFA device using the second reader when ready.

[0060] Figure 1AAn example machine-readable LFA reader application 117 instructs components of the reader 116 to generate electromagnetic signals at various time points 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 a result to verify that the correct device is being read, and (c) obtain a result (e.g., one or more digital voltages and / or currents corresponding to the result) from the LFA device 104. The example LFA reader application 117 causes an electromagnetic field to be generated at the second time to verify the identification information to ensure that the user is reading the test from the correct LFA device (e.g., when multiple tests are being read simultaneously). The example machine-readable LFA reader application 117 identifies the result of an LFA-based test by interacting with the wireless chip 114 (e.g., receiving a wireless signal that identifies the result of the test). For example, the machine-readable LFA reader application 117 controls components of the reader 116 to obtain identification information corresponding to the machine-readable LFA device 104 and / or the test result via signals such as NFC, RFID, etc. 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 can determine whether a test has been read, the type of test being performed, the algorithm for identifying and / or classifying the result of the test, whether the test has expired or been withdrawn, etc. The algorithm (e.g., corresponding to how and when to read one or more electrical signals from a particular LFA device) can be stored locally at the reader 116 and / or can be configured, reconfigured, updated, etc. remotely (e.g., via patches, updates, remote instructions, etc.). Once the test result (e.g., a sample from the LFA device 104) is obtained, the machine-readable LFA reader application 117 determines whether the test is ready (e.g., based on a determination corresponding to a control zone), and if ready, determines the result of the test based on the corresponding algorithm (e.g., using voltage and / or current samples from the test line), and displays the result using the example user interface 120, stores the result in a local database, and / or transmits the result to a monitoring entity for monitoring and / or statistical analysis. In this way, a manufacturer or other party can process the result, perform diagnostics, and / or identify whether a particular LFA device might be counterfeited (e.g., if 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 identification information from the wireless chip 114) various other background information, including lot number, cut-off date, expiration date, test information, signal quality information, chain of custody, etc.Additionally or alternatively, in some examples, the LFA reader application 117 transmits processed data or data generated by one or more levels of analysis. This is described further below. Figure 5 Further disclosed are example machine-readable LFA reader applications 117.

[0061] Figure 1A An example antenna 118 of an example reader 116 (e.g., via example antenna 115) wirelessly powers and / or wirelessly communicates with an example wireless chip 114. For example, based on instructions from the example machine-readable LFA reader application 117, antenna 118 emits 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.

[0062] Figure 1B is Figure 1A A side view of an LFA component of an LFA device 104. Figure 1B including Figure 1A An example sample pad 106, an example conjugate pad 108, an example porous medium 109, (multiple) portions of example bioelectrochemical cells 111a - 111n, and an example wicking pad 112. The example bioelectrochemical cells 111a - n are connected to an example wireless chip 114 via electrodes, as described above in connection with Figure 1A as described above in connection with Figure 1A as described.

[0063] Figure 2A illustrates Figure 1A A top view of an example implementation of a porous medium 109 of a machine-readable lateral flow immunoassay 104. In Figure 2A the example, the membrane 109 serves as Figure 1A the bioelectrochemical cells 111a - n. Figure 2A The example also includes two control lines (e.g., a positive control (PC) and a negative control (NC)), a test line (T1), and example electrodes 202a - 202f. Although the example porous medium 109 has two control lines, one test line, and six electrodes, the porous medium 109 can have any number of test lines, control lines, and / or electrodes.

[0064] The negative control line includes immobilized antibodies and / or antigens for coupling to a corresponding target analyte that, when a sample is applied to the sample pad 106, binds to the immobilized antibodies. The negative control line is included to verify that the current generated at the corresponding electrodes 202e, 202f is strong enough for a valid test measurement. For the test to be valid, the amount of voltage and / or current across electrodes 202e, 202f on the negative control line should be below a threshold.

[0065] The positive control line comprises immobilized antibodies, analytes, and / or antigens conjugated to specific and / or excess conjugates labeled with GOx and / or gold nanoparticles and / or probes labeled with GOx and / or gold nanoparticles that flow from the conjugate pad 108 towards the wicking pad 112. When the sample flows towards the wicking pad 112, the positive control line is the last segment to which the conjugate and / or probe adheres, resulting in the generation of a voltage and / or current between electrodes 202a, 202b. In this way, when the result of the voltage and / or current measurement across electrodes 202a, 202b results in positive (e.g., greater than a threshold amount of voltage and / or current), the reader 116 knows if the test is ready. Example test line T1 has immobilized antibodies, analytes, and / or antigens corresponding to the target analyte conjugated to one or more porous media 109. Thus, if the target analyte of T1 is present in the sample, the target analyte (which adheres to the conjugated antibody, analyte, and / or antigen labeled with GOx and / or silver nitrate) is immobilized at the T1 line.

[0066] Although Figure 2AExample electrodes 202a-f have different widths, but example electrodes 202a-f can have the same width and / or be structured to any width. The width of 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 with a particular test zone, and beyond the reference region, etc. In some examples, electrodes 202a, 202c, 202e are wider than electrodes 102b, 102d, 102f (e.g., reference electrodes), and electrodes 202a, 202c, 202e are wider than the test band to allow the most flexible positioning tolerances during the assembly and manufacturing / printing of the test strip. The spacing between the working electrode and the counter electrode pairs [electrode 202a, reference electrode 202b], [electrode 202c, reference electrode 202d], [electrode 202e, reference electrode 202f] is as small as possible (e.g., from 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 electrodes are carbon electrodes. By having pairs of electrodes (e.g., working electrode and reference electrode) for a single test line and / or control line, a salt bridge with a low impedance amount can be created between the pairs of electrodes on the porous membrane 109. In this way, the voltage and / or current between the pairs of electrodes can be read without using an external power source to facilitate the generation of voltage and / or current. In some examples, electrodes 202a-202f are not joined to the porous medium 109 until the time of reading the result, as further described below. Thus, one or more mechanical devices can be used to keep electrodes 202a-202f disengaged from the porous medium 109 (e.g., not in contact with the porous medium 109) until the time of reading the result.

[0067] In some examples, a voltage regulator and / or driver of the wireless chip 114 may apply a potential (e.g., voltage, bias, etc.) across one or more of the electrodes 202a - 202f to assist, facilitate, and / or improve one or more chemical reactions that will occur on the porous membrane 109. In some examples, the applied potential is a poised potential or a poise. Applying a potential to the (multiple) electrodes facilitates and / or induces chemical reactions (oxidation and / or reduction) to obtain a stronger signal corresponding to the presence of the target analyte. Stronger signals include, for example, an increased current signal amplitude, more stable polarity, reduced signal spread, a greater signal-to-noise ratio, and / or higher sensitivity (e.g., from 0.01% to 0.001%). For example, when the target analyte is present, the poise or potential affects the chemical reaction to allow more electrons to flow. For example, the penetration of electrons through the electrode surface of the analyte is related to the applied potential (e.g., resulting in qualitative analysis). Thus, applying the potential forces the reaction of the copper of the electrode from the oxidized form to the reduced form. In some examples, the amount of poise, bias, and / or voltage may force and / or assist different parts of the chemical reaction. Thus, in some examples, one or more poises and / or voltages may be applied to assist one or more of the chemical reactions that result in current flow when the target analyte is present. The application of the potential and / or poise results in increased sensitivity and / or higher signal robustness. As further described below, the driver and / or voltage regulator of the wireless chip 114 will regulate a 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 can be used to apply one or more voltages (e.g., a poised potential) to the electrodes 202a - 202f, thereby increasing the signal strength of the current / voltage measured when the target analyte is present during testing. For example, the wireless chip 114 may generate a 150mV voltage by regulating a power supply voltage (1.8V, 3.3V, 5V, etc.) to 150mV and applying 150mV to the electrode 202a to assist and / or improve the chemical reaction at the test zone. In this way, more electrons flow from the test zone to the zone corresponding to the electrode 202b (e.g., the non - test zone) compared to the electrons that would flow without applying the potential. The potential that improves one or more chemical reactions may correspond to a positive voltage or a negative voltage. The feeding (e.g., application) of the potential may be applied via the working electrode or the counter electrode (e.g., depending on whether the voltage is positive or negative). Since the wireless chip 114 uses the energy obtained from the antenna 115 via the electromagnetic field, the wireless chip 114 can apply the (multiple) potential and / or (multiple) poise without using a battery.

[0068] InFigure 2A In an example, the porous medium 109 itself serves as the salt bridge of the biofuel cell. The biofuel cell uses additional enzymes (e.g., reductases such as laccase) at the counter electrode (e.g., the cathode). In such an example, laccase reduces oxygen (O2) to 2H2O with 4e - +4H + by a reaction at the anode. When the target analyte reacts with a redox substance that serves as an electron mediator and binds to the released enzyme substrate (e.g., glucose), the porous membrane 109 generates a voltage and / or current. In Figure 2A an example, chromatography paper (e.g., the impregnated paper of the above-described biofuel cells 111a-d) is not included, and the enzyme substrate (e.g., glucose) and / or the redox agent are included in a holding member (e.g., a blister, a stamping cavity, a sac, a bag, etc.), in a buffer, coated on an electrode, etc. In this way, when the liquid assay buffer including the redox agent is applied to the sample pad 106, the liquid assay buffer saturates the porous medium 109. In some examples, after a threshold amount of time, the user and / or the medical technician perform an action on a mechanical component (such as a button (e.g., as further described below in connection with Figures 2G to 2Q ), a slider (e.g., as further described below in connection with Figures 2K to 2Q ), and / or another interface of the housing of the LFA device) to move the electrodes 202a-f into contact with the porous membrane 109, slice the porous medium at (a) predetermined location(s), and / or break the holding member to release glucose at the test area and / or the control area, as further described below in connection with Figures 2G to 2Q ). If the target analyte is present in the sample, the corresponding conjugate / probe labeled with an enzyme (e.g., GOx / gold nanoparticles) becomes immobilized at the corresponding test area. Since the porous medium 109 is saturated and the enzyme substrate (e.g., glucose) and the redox agent are present (e.g., as part of the buffer, coated on the porous medium and / or the electrode, included in a blister or other holding compartment, etc.), the enzyme (e.g., GOx) will react with the enzyme substrate (e.g., glucose) on the test area (e.g., oxidize it), and the redox agent serves as an electron mediator to reduce [Fe(CN)6] 3- 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. Therefore, Figure 2A and Figure 2BAn example is a bioelectrochemical cell integrated into the LFA. In some examples, when a retention component is utilized, the retention component dissolves after being exposed to a threshold amount of time of glucose and / or releasing glucose, as further described below. Because glucose is released onto the porous membrane after the threshold amount of time, the flow of liquid (e.g., corresponding to the sample and / or buffer) has significantly slowed and / or stopped. Accordingly, the hydrogen peroxide generated at the test and / or control zones will not flow or will flow too slowly to reach subsequent test and / or control lines, thereby reducing and / or eliminating background noise corresponding to hydrogen peroxide seeping onto subsequent test lines and reacting with subsequent electrodes.

[0069] In some examples, oxygen may be needed to assist in generating hydrogen peroxide. However, when the electrodes 202a-f are placed in contact with the porous medium 109, there may not be sufficient ambient oxygen to facilitate the generation of a sufficient amount of hydrogen peroxide. Accordingly, the electrodes 202a-f may include one or more incisions (e.g., one or more holes having one or more shapes and / or sizes) to provide a pathway to ambient oxygen to generate sufficient hydrogen peroxide when glucose and GOx react. Additionally or alternatively, the example electrodes 202a-f may be shaped to contact the porous medium 109 while providing space for ambient oxygen. For example, the electrodes 202a-f may be curved, include a wave pattern, and / or include any other pattern capable of contacting the porous membrane 109 and providing gaps and / or voids to include ambient oxygen that can be used to assist in generating hydrogen peroxide.

[0070] As described above, in some examples, for the bioelectrochemical cells 111a-d, an enzymatic reaction may occur with a natural mediator (e.g., oxygen). In such examples, glucose is oxidized to gluconolactone and FADH2 is oxidized to FAD, thereby producing H2O2. Additionally or alternatively, glucose may oxidize and reduce oxygen in the presence of glucose oxidase, resulting in the reaction of C6H 12 O6 and oxygen (O2) and generating C6H 10 O6 and a product (e.g., H2O2 (hydrogen peroxide)). In such examples, the electrodes may be made of a metal (e.g., copper) or a screen-printed carbon electrode doped with ferrocyanide. In this manner, H2O2 is reduced and the metal or ferrocyanide of the electrode is oxidized by the release of electrons. In the latter case, ferrocyanide [Fe(CN)6] 4- reacts to [Fe(CN)6] 3-。The released electrons can be measured by a sensor (e.g., using current and / or voltage measurements) and processed by a processor (e.g., locally at the wireless chip 114 and / or at the reader 116) to determine the test result. Copper surfaces are typically oxidized by air to Cu2O (Cu(I)). Cu2O is oxidized to CuO (Cu(II)) by the reduction of H2O2.

[0071] Additionally, the electrochemical measurement is based on the diffusion process between the electrodes 202a-f. Using a complete flow, convection is an additional factor that, along with diffusion, affects the current result of the biochemical reaction. Thus, after a product (e.g., hydrogen peroxide) that can react with the electrodes to cause current flow is generated 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 electrodes 202a-f contact 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 electrodes 202a-f to generate an electrical signal (e.g., via the release of electrons). Thus, the examples disclosed herein can block (e.g., slow down, stop, etc.) the flow (e.g., completely or partially) to prevent and / or slow down the migration of the product away from the test area and / or control area. In some examples, a mechanical device can be used to block the flow by cutting (e.g., completely or partially) the example porous medium 109 at the example membrane cut 201, thereby stopping the product from flowing towards the example wicking pad 112. Additionally or alternatively, the flow can be blocked by applying a substance (e.g., glue, gel, chemicals, etc.) to the porous membrane 109, activating a substance on the porous membrane 109, squeezing the porous membrane 109, etc. In this way, the product (e.g., hydrogen peroxide) will remain at the corresponding test and / or control line to react with the glucose and / or metal of the electrodes 202a-f. Although Figure 2A the examples include two membrane cuts 201 (e.g., before the first test line / control line and after the last test line / control line), there can be membrane cuts between different test lines / control lines and / or the membrane cut before the first test line / control line can be removed. In some examples, the porous membrane 109 can be cut and / or compressed by moving a slider from a first position to a second position, as further described below in connection with Figures 2K to 2Q 。

[0072] Additionally or alternatively, a mechanical device can apply compression to the porous medium 109 to create a barrier (e.g., along the line shown at the membrane cut 201) that acts as a barrier to stop the product (e.g., hydrogen peroxide) from flowing towards the wicking pad 112. In some examples, the porous membrane 109 can be compressed by moving a button from a first position to a second position, as further described below in connection with Figures 2G to 2JThis is further described. Additionally or alternatively, a chemical substance (e.g., glue, gel, oil, etc.) can be added onto or included on and / or within the porous membrane (e.g., along the line shown at membrane incision 201), which acts as a barrier to stop the flow of the product towards the wicking pad 112. Additionally or alternatively, any mechanism (e.g., mechanical, electrical, chemical, etc.) can be used to block the flow to prevent the product (e.g., hydrogen peroxide) from flowing away from the test area and / or the control area.

[0073] Further, as disclosed herein, in an alternative example, an enzyme-free amperometric redox reaction can be used in the bioelectrochemical cells 111a-d. For example, the amperometric signal of the LFA device 104 can be measured in the absence of 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 above in processes 6-8. Additionally, as shown in process 8 above, thiosulfate, ferricyanide, and KBr or KCl react, and the AuNP will catalyze the reduction of ferricyanide to generate an electronic signal.

[0074] For example, in Figure 2A , the electrode 202c is in contact with the T1 test area, and the electrode 202d is in contact with a non-test area (e.g., a porous medium outside the PC area, the T1 area, and the NC area). In such an example, if the target analyte corresponding to T1 is present in the sample, then when the sample is applied to the sample pad 106, the sample will flow into the conjugate pad 108 and bind to the conjugate and / or probe labeled with GOx, gold nanoparticles, and / or other label(s), and continue to flow through the porous medium 109 and into the wicking pad 112. Because the target analyte is present in the sample, the target analyte attached to the conjugate / probe labeled with GOx / gold nanoparticles will be immobilized at the test area T1. Thus, after the porous medium 109 is saturated with the liquid assay buffer (e.g., a threshold time after applying a liquid buffer assay comprising a redox substance to the sample pad 106), glucose is released, and the electrodes 202a-202f are positioned to contact the porous medium 109. The GOx / gold nanoparticles at the test area T1 will oxidize the glucose at the test area T1 to generate a voltage drop (illustrated as U2 in Figure 2A ) and / or current between the test area T1 and the area adjacent to the test area where the electrode 202d is located. The exemplary wireless chip 114 measures the voltage drop and / or current from the electrode 202c to the electrode 202d, and determines the presence of the target analyte when the voltage drop and / or current is above a threshold.

[0075] In operation, when Figure 2A 's example is in Figure 1AWhen implemented in the LFA device 104, a user or technician applies a sample (e.g., 25 microliters of urine, blood, etc.) to the exemplary 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 with an oxidizing and reducing 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 of the porous medium 109 to activate. 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 interacts with the LFA device using the reader 116 to obtain a diagnostic test result (e.g., by generating an electromagnetic field), and within a duration (e.g., 1 minute), the wireless chip 114 of the LFA device 104 transmits the result to the reader 116 using the antenna 115. In some examples, the duration for reading the diagnostic test result can be other values, such as less than one minute or greater than one minute or more minutes (e.g., 2 minutes, 3 minutes, or longer). In some examples, the reader 116 instructs the user to take one or more actions to cause glucose to be released from the holding component and the electrodes 202a - 202f to contact the porous medium 109 and / or to block the flow on the LFA device 104. In such examples, the reader 116 can instruct the user to take actions within a second duration (e.g., 5 minutes) after the 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 to be sheared before the second duration (e.g., 5 minutes). The amount of time the reader 116 needs 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 actions have been taken to move the electrodes 202a - 202f into place and / or to block the flow. Thereafter, the reader 116 starts a clock, timer, and / or countdown for the duration (e.g., 1 minute) to read the diagnostic test. In some examples, the reader 116 provides a presentation on the user interface 120 indicating the times and durations disclosed herein.

[0076] Figure 2B Schematic Figure 2A Side view of the porous medium 109 of a machine-readable lateral flow immunoassay. In Figure 2B the example, the layer with electrodes 202a - f is in direct contact with the porous medium 109. In some examples, the electrodes are incorporated into a non-conductive layer, and the non-conductive layer including the electrodes 202a - f is placed (e.g., during manufacturing) in contact with the porous medium such that the electrodes 202a - f are as Figure 2AThe alignment shown in. In some examples, each of the electrodes 202a-f is placed (e.g., during manufacturing) in contact with the porous medium 109 to be aligned as shown in Figure 2A In some examples, the electrodes 202a-f do not contact the porous membrane 109 until the device is ready to be read. In such examples, the user or the device / component may dock and / or engage with a mechanical device (e.g., Figures 2G to 2J the push button 228) to cause the electrodes to contact the porous membrane 109, as further described below.

[0077] Figure 2C The illustrated exemplary conjugate, which may be attached to the porous medium 109 of a machine-readable lateral flow immunoassay for an exemplary HIV test and / or immobilized antigens, analytes, and / or antibodies on the test area coupled to the porous medium 109. Figures 1A to 2B The illustrated exemplary conjugate, which may be attached to the porous medium 109 of a machine-readable lateral flow immunoassay for an exemplary HIV test and / or immobilized antigens, analytes, and / or antibodies on the test area coupled to the porous medium 109. Figure 2C The illustrated exemplary implementation 204. Figure 2C Also includes the 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. Although Figure 2C the examples correspond to HIV, the exemplary implementation 204 can be used to detect any target analyte.

[0078] During the test, the user and / or patient apply a patient biological sample and / or buffer solution via the sample pad 106. In Figure 2C the example, the sample includes the exemplary HIV-1 target analyte 206. The biological sample and / or buffer flows towards Figure 1A and Figure 1B the exemplary wicking pad 112 in the example. The exemplary conjugate pad 108 is pretreated with the exemplary recombinant HIV-1 capture antigen 208 (e.g., gp41 and p24) linked to (e.g., attached to, labeled with, etc.) an enzyme (e.g., glucose oxidase) and the exemplary HIV-2 capture antigen 210 (e.g., gp36). Since the biological sample includes Figure 2Cto the example target analyte 206, so that the example target analyte 206 attaches to the example HIV-1 capture antigen 208 and glucose (e.g., corresponding to the formation of the example HIV-1 antibody, HIV-1 antigen, and glucose oxidase complex 211), which is transported toward the wicking pad 112. Test line 1 is coated with the example recombinant immobilized HIV-1 antigen 212 (e.g., gp41 and p24), and test line 2 is coated with the example recombinant immobilized HIV-2 antigen 214 (e.g., gp36). In the case of a positive patient sample with the HIV-1 antigen 208, the antibody-antigen-glucose oxidase complex 211 binds to the immobilized recombinant HIV-1 antigen 212 on test line 1. However, since the biological sample does not include the HIV-2 target analyte, nothing binds to test line 2. As described above, the antigen-antibody complex 211 linked to the enzyme (e.g., glucose oxidase) produces a product (e.g., hydrogen peroxide) on test line 1 when the enzyme reacts with the enzyme substrate (e.g., glucose released from the holding member 218, included in the buffer, coated on the electrode and / or porous medium, etc.). In Figure 2C the example, the holding member 218 is a blister, a stamping cavity, a capsule, a bag, etc., which holds the enzyme substrate until it is broken, ruptured, dissolved, etc. Examples of the disruption of the holding member 218 are further described below in connection with Figure 2P and / or Figure 2Q . Figure 2C The control line of

[0079] Figures 2D to 2F illustrated in Figures 1A to 2C includes the example antiserum 216 (e.g., goat anti-recombinant HIV antiserum) that binds to the example recombinant HIV-1 antigen 208. However, if glucose is applied when the flow of the liquid buffer and / or the sample is strong, the glucose can react with the glucose oxidase to generate hydrogen peroxide, which can flow out of the test line and / or the control line. For example, the hydrogen peroxide generated at one of the test lines can flow (e.g., seep) toward the other test lines and / or the control line, resulting in background noise (e.g., when the excess hydrogen peroxide reacts with another electrode to generate some electron flow), which can lead to false positive results. Figure 1A Examples of the front-end channels 220, 222, 224 for docking between the example bioelectrochemical cells 111a-d of Figures 1A to 2C and the wireless chip 114 of Figure 1A . Although the example front-ends 220, 222, 224 can be implemented as components external to the wireless chip 114, the front-ends 220, 222, 224 can be implemented within the wireless chip 114 and / or as part of another device. If the example wireless chip 114 is implemented in a stand-alone device (e.g., separate from the LFA 104), the example front-ends 220, 222, 224 can be implemented in the LFA 104 and / or the device including the wireless chip 114.

[0080] Figure 2D The example front-end channel 220 acts as an electronic multiplexer, a group of MOSFETs, and / or any other electronic circuitry to transmit signals received from each of the bioelectrochemical cells 111a-d to four input terminals of the wireless chip 114. The example wireless chip 114 outputs control signals to the example front-end 220 to control which bioelectrochemical cell signal will be processed at different time points. Although Figure 2D the wireless chip 114 of includes four input terminals (e.g., very high, high, low, and very low), the wireless chip 114 can include any number of input terminals corresponding to any number of levels. The four input terminals of the wireless chip 114 compare the magnitude of the acquired signal with a preset threshold to identify the magnitude of the measured voltage or current. For example, if the output of the bioelectrochemical cells 111a-d is a voltage (e.g., for a potentiometric sensor), the first input can compare the magnitude of the acquired voltage with 80 mV, the second input can compare the magnitude of the acquired voltage with 60 mV, the third input can compare the magnitude of the acquired voltage with 40 mV, and the fourth input can compare the magnitude of the acquired voltage with 20 mV. In this way, if the front-end 220 outputs a 70 mV signal from the first bioelectrochemical cell 111a, the wireless chip 114 will determine based on the comparison that the acquired signal is high (e.g., higher than 60 mV) but not very high (e.g., higher than 80 mV). The wireless chip 114 can transmit the determined output intensity (e.g., very high, high, low, or very low) of each measurement result to the example LFA reader application 117. In this way, the results can be further analyzed to identify patterns, identify 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).

[0081] Figure 2EAn example front-end channel 222 is an alternative implementation that acts as a multiplexer and / or demultiplexer to transmit signals received (e.g., accessed, obtained, etc.) from each of the bioelectrochemical cells 111a-d to corresponding input terminals of the wireless chip 114. For example, the front-end channel 222 ensures that the first bioelectrochemical cell 111a outputs to the first input terminal, the second bioelectrochemical cell 111b outputs to the second input terminal, and so on. For example, the front-end channel 222 can be implemented with a multiplexer and a demultiplexer, where 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 terminal of the wireless chip 114, the second output of the bioelectrochemical cell 111b is transmitted to the second input terminal of the wireless chip 114, and so on. The example wireless chip 114 outputs one or more control signals to the example front-end 220 to control which bioelectrochemical cell signals will be processed at different time points. In some examples, the front-end channel 222 can include a multiplexer that is controlled to sample / measure corresponding electrodes among the electrodes at different time points, and each measurement result 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 222 is controlled to make multiple measurements for each test line and multiple measurements for each control line. For example, the front-end 222 is controlled to make multiple measurements for the test line and the control line, where the wireless chip 114 transmits multiple results to the reader 116 and / or performs statistical preprocessing of the multiple measurement results before sending the data to the reader 116. Although Figure 2F the wireless chip 114 includes four input terminals (e.g., for four bioelectrochemical cells 111a-111d), the wireless chip 114 can include any number of input terminals corresponding to any number of cells, controllers, and / or electrodes. In Figure 2E the example, the input terminals of the wireless chip 114 determine the amounts of current and / or voltage corresponding to the first bioelectrochemical cells 111a-111d (e.g., as digital values). The wireless chip 114 can transmit the determined output intensity of each measurement to the example LFA reader application 117.

[0082] Figure 2F An example front-end channel 224 is an alternative implementation corresponding to a direct channel between each of the bioelectrochemical cells 111a-d and the corresponding input terminals of the wireless chip 114. For example, the first output terminal of the bioelectrochemical cell 111a is directly coupled to the first input terminal of the wireless chip 114 via the first channel, the second output terminal of the bioelectrochemical cell 111b is directly coupled to the second input terminal of the wireless chip 114 via the second channel, and so on. Although Figure 2FThe wireless chip 114 includes four input terminals (e.g., for four bioelectrochemical cells 111a - 111d), but the wireless chip 114 can include any number of input terminals corresponding to any number of cells, controllers, and / or electrodes. In Figure 2F the example, the input terminals of the wireless chip 114 determine the amount of current and / or voltage corresponding to the first bioelectrochemical cells 111a - 111d (e.g., as a digital value). The wireless chip 114 can transmit each measured and determined output intensity to the example LFA reader application 117.

[0083] Although Figure 2D 、 Figure 2E 、 Figure 2F the example wireless chip 114 includes a comparator for comparing the obtained amount of voltage and / or current with a threshold and transmitting the result corresponding to the comparison, the example wireless chip 114 can include an analog - to - digital converter for converting analog voltage and / or current readings into digital values and transmitting the digital values to the example reader 116. In this way, the example reader 116 can compare the digital values with one or more thresholds to determine the result. In some examples, the wireless chip 114 can obtain multiple voltage and / or current measurement results (e.g., voltage samples, current samples, etc.) for each test line and control line, convert the measurement results into digital values, and transmit all the digital values to the example reader 116. In some examples, the wireless chip 114 can perform pre - processing of the values (e.g., statistical analysis such as determining the mean, median, mode, standard deviation, etc. of multiple measurement results), and transmit one or more values representing the multiple measurement results to the reader 116.

[0084] Figure 2G Illustrated is an example housing 226 of an example LFA device 104 for Figure 1A . The example housing 226 includes an example push - down button 228 and an example sample port or storage space 230 (e.g., also referred to as a hole, opening, gap, etc.). In Figure 2G the example, the push - down button 228 is in the first position. The push - down button 228 can move from a first initial position (e.g., raised and disengaged position) to a second final position (e.g., lowered and engaged position), as shown in Figure 2H .

[0085] As described above, when the test is ready to be read, the user will Figure 2GPushing and / or pressing the depression button 228 from the first position to the second position causes the electrodes 202a-f to contact the porous medium 109. In some examples, the depression button 228 includes a blade or is coupled to a blade. Thus, pushing the depression button 228 from the first position to the second position causes the blade of the depression button 228 to cut, compress, slice, extrude, etc. the porous medium 109 to stop and / or otherwise slow the flow of liquid on the porous medium 109, as shown in connection with Figure 2A the membrane cut 201 shown.

[0086] Additionally or alternatively, to prevent the leakage of hydrogen peroxide, one or more blisters may be used. In such examples, the blister may include a redox agent and / or an enzyme substrate at a specific location of the porous medium 109 to ensure that the generation of hydrogen peroxide occurs only at the specific location when the target analyte is present. The depression button 228 may include text and / or an image. Additionally, the depression button 228 may be textured to provide a grip for the user. The textured portion of the depression button 228 may be made of the same or a different material from the rest of the depression button 228.

[0087] Figure 2G The storage space 230 of

[0088] Figure 2H is a groove, an opening, a hole, etc., where a liquid sample and / or a buffer may be applied to the porous medium 109 via the sample pad 106 (e.g., the sample pad 106 is located directly below the storage space 230). In some examples, the storage space 230 includes two or more storage spaces (e.g., one for the sample and one for the buffer). In some examples, the storage space 230 is sized to match the width of the sample pad 106.

[0088] Figure 2H is a groove, an opening, a hole, etc., where a liquid sample and / or a buffer may be applied to the porous medium 109 via the sample pad 106 (e.g., the sample pad 106 is located directly below the storage space 230). In some examples, the storage space 230 includes two or more storage spaces (e.g., one for the sample and one for the buffer). In some examples, the storage space 230 is sized to match the width of the sample pad 106. Figure 1A An example housing 226 of the LFA device 104 shown in the second position. The housing 226 includes the Figure 2G depression button 228 that has been pushed into the second position. As described above, pushing the depression button 228 into the second position places the Figure 2A electrodes 202a-f in contact with the porous medium 109 and / or cuts, compresses, slices, and / or extrudes one or more portions of the example porous medium 109. Figure 2H Also illustrated is that text and / or an image(s) may be included on the housing 226.

[0089] Figure 2I Illustrated is Figure 2G and Figure 2H an exploded view of an example housing 226. The example housing 226 of FIG. 21 includes Figures 2G to 2HThe push - down button 228. The exemplary housing 226 of FIG. 21 also includes an exemplary first part 232 and an exemplary second part 234. The first part 232 and the second part 234 house an exemplary printed circuit board (PCB) layer 236 and an exemplary LFA strip 238.

[0090] The exemplary first part 232 is the upper housing of the exemplary housing 226. The exemplary first part 232 includes a structure for assisting the movement of the exemplary push - down button 228. For example, the push - down button 228 includes four guide rings to engage with the guide posts of the housing 232 to ensure that the push - down button 228 does not move laterally from its intended position. Additionally, the push - down button 228 may include one or more clamping portions to engage with one or more clamping portions of the lower housing 234. In this way, when the push - down button 228 is pushed from a first position into a second position, the clamping portions of the push - down button 228 engage with the lower housing 234 to cause the push - down button 228 to remain in the second position (e.g., to keep the electrodes 202a - 202f in contact with the porous medium 109). For example, when the push - down button 228 moves between the first position and the second position, the guide rings can slide along the guide posts to prevent the push - down button 228 from tilting. The exemplary PCB layer 236 houses Figure 1A the electronics of the exemplary LFA device 104. For example, the PCB layer 236 may include and / or be connected to the bio - electrochemical cells 111a - d, the wireless chip 114, the antenna 115, the electrodes 202a - f, and / or Figures 1A to 2F the exemplary front channels 220, 222, 224. The LFA strip 238 includes Figures 1A to 2B the sample pad 106, the conjugate pad 108, the porous medium 109, the test portion and / or the control portion, and the wicking pad 112 of the LFA device 104. The second part 234 is the lower housing that holds the upper housing 226 and / or the push - down button 228 to enclose the PCB layer 236 and the LFA strip 238.

[0091] Figure 2J Illustrated Figure 2I a top - view of a cross - section of the housing 226 with respect to Figure 2G the A - A line of FIG. The exemplary housing 226 supports the exemplary PCB layer 236 of FIG. 21. The exemplary PCB layer 236 includes an exemplary bridging section 239 that links one side of the PCB layer 236 to the other side of the PCB layer 236. The bridging section 239 is structured to engage with Figure 1A and / or Figure 1B the sample pad 106 and / or Figure 2G and / or Figure 2HThe storage space 230 is separated or isolated to prevent the liquid sample and / or buffer from flowing on the PCB layer 236 before the actuation of the push button 228. Thus, the bridging section 239 does not impede the flow across the LFA strip 238. In some examples, the exemplary PCB layer 236 can be made of flame retardant (FR) 4 (FR-4) with a total thickness of 0.61 millimeters. When the push button 228 is pressed, the PCB layer 236 can act as a spring.

[0092] Figure 2K Illustrated for Figure 1A an exemplary housing 258 of an exemplary LFA device 104. The exemplary housing 258 includes an exemplary slider 260 and an exemplary sample port or storage space 230 (e.g., also referred to as a hole, gap, etc.). In Figure 2K an example, the slider 260 is in a first position. The slider 260 can move from the first position (e.g., where the storage space 230 is exposed) to a second position (e.g., where the storage space 230 is covered), as Figure 2L shown.

[0093] As described above, when the test is ready to be read, moving Figure 2K the slider 260 of to the second position from the first position causes the electrodes 202a-f to contact the porous medium 109. In some examples, moving the slider 260 from the first position to the second position compresses, cuts, slices, extrudes, etc. the porous medium 109 to stop and / or otherwise slow down the flow of the liquid on the porous medium 109, as shown in connection with Figure 2A the membrane cut 201. The slider 260 can include text and / or images. Additionally, the slider 260 can be textured to provide a grip for the user. The textured portion of the slider 260 can be made of the same or a different material than the rest of the slider 260.

[0094] Figure 2K The storage space 230 is a groove, opening, hole, etc., where a liquid sample and / or buffer can be applied to the porous medium 109 via the sample pad 106 (e.g., the sample pad 106 is located directly below the storage space 230). In some examples, the storage space 230 includes two or more storage spaces (e.g., one for the sample and one for the buffer). In some examples, the exemplary storage space 230 is sized to match the width of the sample pad 106.

[0095] Figure 2L Illustrated in the second position Figure 1A an exemplary housing 258 of the LFA device 104. The housing 258 includes a Figure 2K moving from the first position to the second position Figure 2KThe slider 260. As described above, moving the slider 260 to the second position will Figure 2A The electrodes 202a-f are placed in contact with and / or compress, cut, slice, and / or extrude one or more portions of the exemplary porous medium 109. In the second position, the slider 260 covers the exemplary storage space 230. Figure 2L It is also illustrated that text and / or (a)n image may be included on the housing 258 that is exposed when the exemplary slider 260 is in the second position. In some examples, the text includes instructions, such as instructions for obtaining the results of a diagnostic test.

[0096] Figure 2M Illustrated Figure 2K and Figure 2L An exploded view of the exemplary housing 258. Figure 2M The exemplary housing 258 includes Figures 2K to 2L The slider 260. Figure 2M The exemplary housing 258 also includes an exemplary first part 262 and an exemplary second part 264. The first part 262 and the second part 264 house the exemplary printed circuit board (PCB) layer 266 and the exemplary LFA strip 268.

[0097] The exemplary first part 262 is the upper housing of the exemplary housing 258. The exemplary first part 262 includes structures that facilitate the movement of the exemplary slider 260, as further described below in connection with FIG. 20. The exemplary PCB layer 266 houses Figure 1A The electronics of the exemplary LFA device 104. For example, the PCB layer 266 may include and / or be connected to the bioelectrochemical cells 111a-d, the wireless chip 114, the antenna 115, the electrodes 202a-f, and / or Figures 1A to 2F The exemplary front channels 220, 222, 224. The LFA strip 268 includes Figures 1A to 2B The sample pad 106, the conjugate pad 108, the porous medium 109, the test portion and / or the control portion, the wicking pad 112 of the LFA device 104. The second part 264 is the lower housing that holds the first part 262 of the housing 258 and / or the slider 260 to enclose the PCB layer 266 and the LFA strip 268.

[0098] Figure 2N Illustrated Figure 2M A top view of a cross-section of the housing 258 with respect to Figure 2K The B-B line. The exemplary housing 258 supports Figure 2M The exemplary PCB layer 266. The exemplary PCB layer 266 includes an exemplary bridging segment 267 that links one side of the PCB layer 266 to the other side of the PCB layer 266. The bridging segment 267 is configured to cooperate with Figure 1A and / or Figure 1Bthe sample pad 106 and / or Figure 2K and / or Figure 2L the storage space 230 are separated or disengaged to prevent the liquid sample and / or buffer from flowing on the PCB layer 266 before actuation of the slider 260. Accordingly, the bridging section 267 does not impede the flow across the LFA strip 268.

[0099] Figure 2O Illustration Figure 2K and Figure 2L a cross-sectional view of the exemplary housing 258 relative to Figure 2K the C-C line, and rotated 180 degrees horizontally with the slider 260 in a first position ( Figure 2O top view in Figure 2O and a second position (

[0100] Figure 2P Illustration Figure 1A destruction of the housing of the exemplary LFA device 104 Figure 2C operation of the exemplary holding member 218 to release glucose. Figure 2P The exemplary LFA device 104 includes Figure 1AExample sample pad 106 (e.g., exposed via an opening). The example LFA device 104 also includes an example slider 294 and an example safety latch 296.

[0101] At time t1, the user applies the sample via the opening to the sample pad 106. At time t1, the safety latch 296 is in place to prevent movement of the slider 294. At time t2, the user waits for a duration (e.g., 15 minutes) to allow the sample to flow through Figure 1A the porous medium 109. At time t3, the user removes and / or discards the safety latch 296. Removing the safety latch 296 unlocks the slider 294. In this way, the user can slide the slider 294 from the first position to the second position. In some examples, removing the safety latch 296 breaks or otherwise causes the holding member 218 to release glucose and / or an oxidation-reduction agent. From time t4 to t5, the user moves the example slider 294 from the first position (at time t4) to the second position (at time t5). In some examples, moving the slider 294 from the first position to the second position causes the holding member 218 to break and / or release the glucose and / or oxidation-reduction agent contained in the holding member 218. In some examples, the movement of the slider 294 can additionally push the electrodes 202a-f into the porous medium 109 and / or slide and / or press the porous medium 109 to stop and / or slow the flow. In some examples, Figure 2P the components of the slider 294 can be combined with Figures 2K to 2O the slider 260. In some examples, time t3 and time t4 are substantially simultaneous.

[0102] Figure 2Q Illustration Figure 1A the housing of the example LFA device 104 breaks Figure 2C the example holding member 218 to release glucose for an alternative operation. Figure 2Q Examples include a locking mechanism (e.g., safety latch 296) to prevent movement of the slider 294. Figure 2Q Examples include two locking mechanisms disclosed below. Figure 2Q The example LFA device 104 includes Figure 1A an example sample pad 106 (e.g., exposed via an opening). The example LFA device 104 also includes an example safety latch 296 and an example slider 298.

[0103] At time t1, the user applies the sample via the opening to the sample pad 106. At time t1, the safety latch 296 (e.g., the first locking mechanism) is in place to prevent movement of the slider 298. In Figure 2Q the example, the safety latch 296 is located at one end of the slider 298. At time t2, the user waits for a duration (e.g., 15 minutes) to allow the sample to flow throughFigure 1A porous medium 109. At time t3, the user removes and / or discards the safety latch 296. Removing the safety latch 296 unlocks the slider 298 to slide in the first direction. In this way, the user can slide the slider 298 from the first position to the second position. In some examples, removing the safety latch 296 causes the holding member 218 to break and / or release glucose and / or redox agent on the porous membrane 109. At time t4, the user moves the exemplary slider 298 from the first position to the second position in the first direction. In some examples, time t3 and time t4 are substantially simultaneous. Sliding the slider 298 from the first position to the second position unlocks the slider 298 (e.g., unlocks the second locking mechanism). The unlocked slider 298 is capable of sliding in the second direction (e.g., from the second position to the third position). In some examples, moving the slider 298 from the first position to the second position causes the holding member 218 to break and / or release glucose and / or redox agent contained in the holding member 218. In some examples, the movement of the slider 298 from the first position to the second position may additionally push the electrodes 202a-f into the porous medium 109 and / or slide and / or press the porous medium 109 to stop and / or slow down the flow.

[0104] At time t5, the user slides the slider 298 from the second position to the third position, as shown at time t6. In some examples, moving the slider 298 from the second position to the third position may cause the holding member 218 to break and / or release glucose and / or redox agent. Additionally, the movement of the slider 298 from the second position to the third position may push the electrodes 202a-f into the porous medium 109 and / or slide and / or press the porous medium 109 to stop and / or slow down the flow. In some examples, Figure 2Q components of the slider 298 may be combined with Figures 2K to 2O the slider 260.

[0105] Figure 3 is Figure 1A a block diagram of an example implementation of a machine-readable LFA generator 102. The example machine-readable LFA generator 102 includes an example user interface 300, an example part generator 302, and an example part applicator 304.

[0106] Figure 3 The example user interface 300 interfaces with the user and / or manufacturer to obtain instructions on how to structure the machine-readable LFA device 104. For example, the user interface 300 may receive (e.g., access, obtain, etc.) instructions on what type of machine-readable LFA device to generate, how many test zones the LFA device 104 is to perform (e.g., for multiplexed LFA designs) and / or test types, and / or how many control zones and / or types to include in the LFA device 104.

[0107] Figure 3 The example part generator 302 of generates and / or obtains parts of the example LFA device 104. For example, the part generator 302 can generate and / or obtain from storage a sample pad 106, a conjugate pad 108, a porous medium 109, antibodies, antigens, and / or molecules to be applied to the LFA device 104, a wicking pad 112, a wireless chip 114, an antenna 115, a connector, a housing, bioelectrochemical cells 111a-n, an example housing 226, etc. To introduce an enzyme substrate (e.g., glucose), the example part generator 302 can generate an example holding member 218 to hold the enzyme substrate (e.g., glucose).

[0108] Figure 3 The example part applicator 304 of applies the obtained and / or generated parts based on user and / or manufacturing instructions to generate Figures 1A to 2Q the example machine-readable LFA device 104. For example, the part applicator 304 can apply antigens and / or antibodies attached to GOx, silver nitrate, a reducing agent, and / or gold to the obtained and / or generated conjugate pad 108. Additionally, the part applicator 304 structures the parts of the machine-readable LFA device 104 and applies antigens and / or antibodies corresponding to the number of tests, the type of tests, the number of controls, and / or the type of controls to the test areas and / or control areas of the test area 110 on the porous medium 109.

[0109] Although an example manner of implementing Figure 3 the example machine-readable LFA generator 102 is illustrated in Figure 1A it, one or more of the elements, processes, and / or devices illustrated in Figure 3 it can be combined, divided, rearranged, omitted, eliminated, and / or implemented in any other manner. Additionally, Figure 3 the example user interface 300, the example part generator 302, the example part applicator 304, and / or more generally the example machine-readable LFA generator 102 can be implemented by hardware, software, firmware, and / or any combination of hardware, software, and / or firmware. Thus, for example, Figure 3Any of the example user interface 300, example part generator 302, example part applicator 304, and / or more generally example machine-readable LFA generator 102 may be implemented by one or more analog or digital circuits, logic circuits, programmable processor(s), programmable controller(s), graphics processing unit(s) (GPU), digital signal processor(s) (DSP), application specific integrated circuit(s) (ASIC), programmable logic device(s) (PLD), and / or field programmable logic device(s) (FPLD). When reading any of the apparatus or system claims of this patent to cover a pure software and / or firmware implementation, Figure 3 At least one of the example user interface 300, example part generator 302, example part applicator 304, and / or more generally example machine-readable LFA generator 102 is hereby expressly defined to include a non-transitory computer-readable storage device or storage disk, such as a memory, digital versatile disc (DVD), compact disc (CD), Blu-ray disc, etc., including software and / or firmware. Further, Figure 3 The example machine-readable LFA generator 102 may include one or more elements, processes, and / or devices in addition to or instead of Figure 3 those illustrated in Figure 3 and / or may include more than one of any or all of the illustrated elements, processes, and devices. As used herein, the phrase “communicating with” (including its variants) encompasses direct 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 additionally includes selective communication at periodic intervals, scheduled intervals, aperiodic intervals, and / or one-time events.

[0110] Figures 4 to 5 illustrates a flowchart representing example hardware logic, machine-readable instructions, hardware-implemented state machines, and / or any combination thereof for implementing Figure 3 the machine-readable LFA generator 102. The machine-readable instructions may be one or more executable programs or portions of executable programs for execution by a computer processor, such as the processor 612 shown in the example processor platform 600 discussed below in connection with Figure 6 The program may be implemented in software stored on a non-transitory computer-readable storage medium such as a CD-ROM, floppy disk, hard drive, DVD, Blu-ray disc, or memory associated with the processor 612, but the entire program and / or portions thereof may alternatively be executed by a device other than the processor 612 and / or implemented in firmware or dedicated hardware. Additionally, although reference is made to Figures 4 to 5The flowchart illustrated herein depicts an example program, but many other methods for implementing the example machine-readable LFA generator 102 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, eliminated, 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 circuitry, FPGAs, ASICs, comparators, operational amplifiers (op-amps), logic circuits, etc.) structured to perform the corresponding operations without executing software or firmware.

[0111] 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 that can be used to create, manufacture, and / or generate machine-executable instructions (e.g., portions of instructions, code, representations of code, etc.). 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 need to be installed, modified, adapted, updated, combined, supplemented, configured, decrypted, decompressed, unpacked, distributed, redistributed, compiled, etc. in order for them to be directly readable, interpretable, and / or executable by a computing device and / or other machine. For example, the machine-readable instructions may be stored in multiple parts that are individually compressed, encrypted, and stored on separate computing devices, where the parts form a set of executable instructions that implement a program such as that described herein when they are decrypted, decompressed, and combined.

[0112] In another example, the machine-readable instructions may be stored in a state where they are readable by a computer, but libraries (e.g., dynamic link libraries (DLLs)), software development kits (SDKs), application programming interfaces (APIs), etc. may need to be added in order to execute the instructions on a particular computing device or other device. In another example, the machine-readable instructions may need to be configured (e.g., stored settings, data inputs, recorded network addresses, etc.) before the machine-readable instructions and / or the corresponding program(s) can be executed in whole or in part. Accordingly, the disclosed machine-readable instructions and / or the corresponding program(s) are intended to cover such machine-readable instructions and / or programs regardless of the particular format or state of the machine-readable instructions and / or the program(s) when stored or otherwise at rest or in transit.

[0113] The machine-readable instructions described herein can be represented in any past, present, or future instruction language, scripting language, programming language, etc. For example, the machine-readable instructions can be represented using any one of the following languages: C, C++, Java, C#, Perl, Python, JavaScript, Hypertext Markup Language (HTML), Structured Query Language (SQL), Swift, etc.

[0114] As mentioned above, Figures 5 to 7 The example process of can 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 disk 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., an extended period of time, permanently, briefly, 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 propagated signals and to exclude transmission media.

[0115] Figure 4 The figure represents an example flowchart of machine-readable instructions 400 that can be executed to implement Figure 3 An example machine-readable LFA generator 102 of to generate Figures 1A to 2Q One of the example machine-readable LFA devices 104 of. Although Figure 4 The instructions 400 of are described in connection with Figures 1A to 2Q One of the example machine-readable LFA devices 104 of, the example instructions 400 can be described and / or implemented in connection with any type of LFA device of any structure.

[0116] In block 402, the example user interface 300 determines whether instructions for generating the machine-readable LFA device 104 have been obtained. If the example user interface 300 determines that instructions have not been obtained (block 402: no), then control returns to block 402 until instructions are obtained. If the example user interface 300 determines that instructions have been obtained (block 402: yes), then the example part generator 302 determines the number of tests, the type(s) of the test(s), the number of control regions, and / or the type(s) of the control region(s) based on the user instructions (block 404). For example, the user can provide instructions to generate the LFA device 104 to include three test regions corresponding to three target analytes and one positive control region.

[0117] At block 406, example part generator 302 designs and / or obtains a conjugate pad based on the (multiple) types of (multiple) tests and / or the LFA structures identified in the instructions. For example, part generator 302 may generate (and / or obtain from storage) a conjugate pad that includes an antibody and / or an antigen that attaches to a target analyte corresponding to the (multiple) types of (multiple) tests identified in the instructions. For the bioelectrochemical cell LFA device 104, the antigen and / or antibody attaches to GOx or gold nanoparticles (e.g., depending on how the bioelectrochemical cells 111a-n are structured).

[0118] At block 408, example part generator 302 generates and / or obtains example sample pad 106, example porous medium 109, example wicking pad 112, example wireless chip 114, example antenna 115, and / or the LFA housing. At block 410, example part applicator 304 applies (e.g., immobilizes) an antigen and / or an antibody corresponding to the target analyte and / or proximal to the target analyte to the test area and / or control area in test region 110 of porous medium 109. At block 412, example part generator 302 determines whether the instructions correspond to an LFA that is a bioelectrochemical cell LFA device 104. If part generator 302 determines that the LFA does not correspond to the bioelectrochemical cell LFA device 104 (block 412: no), then control continues to block 416. If part generator 302 determines that the LFA corresponds to the bioelectrochemical cell LFA device 104 (block 412: yes), then example part generator 302 generates and / or obtains a bioelectrochemical cell (block 414). Example part generator 302 generates a bioelectrochemical cell by impregnating a paper sheet or other material with an enzyme substrate (e.g., glucose) and / or a reducing agent (e.g., hydroquinone, aminophenol, vitamin C, other ascorbic acids, etc.) and / or an electron mediator or redox substance (e.g., potassium ferricyanide, ferrocene, ferrocene derivatives, etc.). Once impregnated, example part generator 302 allows the bioelectrochemical cell to dry before applying it to the LFA device 104.

[0119] At block 416, example part generator 302 generates example housing 226 to accommodate the lateral flow assay components. As described above, housing 226 includes components that facilitate applying the sample to porous medium 109 and / or pressing the electrodes into place (e.g., in contact with porous medium 109) such that the lateral flow assay can be read by a reader.

[0120] At block 418, example part applicator 304 generates (e.g., assembles and / or applies) one of machine-readable LFAs 104, which includes sample pad 106, example conjugate pad 108, example porous medium 109, example wicking pad 112, example wireless chip 114, housing 226, example antenna 115, circuitry or etched circuit (e.g., to connect wireless chip 114 to test areas and / or battery), electrodes 202a-f, switches, buttons, sliders, (a) restrictor(s), (a) electrode plate(s), (an) actuator(s), and / or LFA housing. At block 420, example part applicator 304 applies example inlet 113 (e.g., by excising a portion of LFA device 104). In some examples, the inlet may not be included. At block 422, example part applicator 304 assembles housing 226 and LFA device 104 such that LFA device 104 is received within housing 226.

[0121] Figure 5 Combined Figures 1A to 2Q One or more of the illustrated representations in the structure of which represent an example flowchart of machine-readable instructions 500 that may be executed to implement Figure 3 Example machine-readable LFA generator 102 to generate one of example machine-readable LFA devices 104, which example machine-readable LFA device 104 includes Figure 2C Retention member 218 of which. Although Figure 5 Instructions 500 of which are described in combination with Figures 1A to 2Q One of example machine-readable LFA devices 104 of which, example instructions 500 may be described and / or implemented in combination with any type of LFA device of any structure.

[0122] At block 502, example user interface 300 determines whether instructions for generating machine-readable LFA device 104 have been obtained. If example user interface 300 determines that instructions have not been obtained (block 502: no), control returns to block 502 until instructions are obtained. If example user interface 300 determines that instructions have been obtained (block 502: yes), example part generator 302 determines the number of tests, the type(s) of (a) test(s), the number of control areas, and / or the type(s) of (a) control area(s) based on the user instructions (block 504). For example, a user may provide instructions to generate LFA device 104 to include three test areas corresponding to three target analytes and one positive control area.

[0123] At block 506, example part generator 302 designs and / or obtains a conjugate pad based on the (multiple) types of (multiple) tests and / or the LFA structures identified in the instructions. For example, part generator 302 may generate (and / or obtain from storage) a conjugate pad that includes an antibody and / or an antigen that attaches to a target analyte corresponding to the (multiple) types of (multiple) tests identified in the instructions. For the bioelectrochemical cell LFA device 104, the antigen and / or antibody attaches to GOx or gold nanoparticles (e.g., depending on how the bioelectrochemical cell 111a-n is structured).

[0124] At block 508, example part generator 302 generates and / or obtains example sample pad 106, example porous medium 109, example wicking pad 112, example wireless chip 114, example antenna 115, and / or the LFA housing. At block 510, example part applicator 304 applies (e.g., immobilizes) an antigen and / or an antibody corresponding to the target analyte and / or proximate to the target analyte to the test area and / or control area in test region 110 of porous medium 109. At block 512, example part generator 302 determines whether the instructions correspond to an LFA that is a bioelectrochemical cell LFA device 104. If part generator 302 determines that the LFA does not correspond to the bioelectrochemical cell LFA device 104 (block 512: no), then control continues to block 516. If part generator 302 determines that the LFA corresponds to the bioelectrochemical cell LFA device 104 (block 512: yes), then example part generator 302 generates and / or obtains a bioelectrochemical cell (block 514). Example part generator 302 generates a bioelectrochemical cell by impregnating a paper sheet or other material with an enzyme substrate (e.g., glucose) and / or a reducing agent (e.g., hydroquinone, aminophenol, vitamin C, other ascorbic acids, etc.) and / or an electron mediator or redox substance (e.g., potassium ferricyanide, ferrocene, ferrocene derivatives, etc.). Once impregnated, example part generator 302 allows the bioelectrochemical cell to dry before applying it to the LFA device 104.

[0125] At block 516, example part generator 302 generates Figure 2C example holding member 218 to hold an enzyme substrate (e.g., glucose). As described above, glucose released from holding member 218 will react with an enzyme (e.g., GOx, if there is a target analyte) to generate a product (e.g., hydrogen peroxide). In this way, the product can react with the electrode to generate an electron flow that can be measured as a current to determine the presence of the target analyte in the sample.

[0126] At block 518, example part applicator 304 generates (e.g., assembles and / or applies) one of machine-readable LFAs 104 that include sample pad 106, example conjugate pad 108, example porous medium 109, example wicking pad 112, example wireless chip 114, holding member 218 that houses an enzyme substrate, example antenna 115, circuitry or etched circuit (e.g., to connect wireless chip 114 to a test zone and / or a battery), electrodes 202a-f, slider 260, flow restrictor 271, electrode plate(s), actuator, and / or LFA housing. At block 520, example part applicator 304 applies example inlet 113 (e.g., by excising a portion of LFA device 104). In some examples, an inlet may not be included.

[0127] Figure 6 is structured to execute Figures 4 to 5 instructions to implement Figure 3 is a block diagram of an example processor platform 600 of machine-readable LFA generator 102. Processor platform 600 can be, for example, a server, a personal computer, a workstation, a self-learning machine (e.g., a neural network), an Internet appliance, or any other type of computing device.

[0128] Illustrated example processor platform 600 includes processor 612. Illustrated example processor 612 is hardware. For example, processor 612 can be implemented by one or more integrated circuits, logic circuits, microprocessors, GPUs, DSPs, or controllers from any desired family or manufacturer. The hardware processor can be a semiconductor (e.g., silicon-based) device. In this example, the processor implements example user interface 300, example part generator 302, and example part applicator 304.

[0129] Illustrated example processor 612 includes local memory 613 (e.g., a cache). Illustrated example processor 612 communicates via bus 618 with main memory that includes volatile memory 614 and non-volatile memory 616. Volatile memory 614 can be implemented by synchronous dynamic random access memory (SDRAM), dynamic random access memory (DRAM), dynamic random access memory and / or any other type of random access memory device. Non-volatile memory 616 can be implemented by flash memory and / or any other desired type of memory device. Access to main memory 614, 616 is controlled by a memory controller.

[0130] Illustrated example processor platform 600 also includes interface circuit 620. Interface circuit 620 can be implemented by any type of interface standard, such as an Ethernet interface, a universal serial bus (USB), an interface, a Near Field Communication (NFC) interface, and / or a PCI Express interface.

[0131] In the illustrated example, one or more input devices 622 are connected to interface circuitry 620. The (multiple) input devices 622 allow a user to input data and / or commands into the processor 612. The (multiple) input devices may be implemented, for example, by an audio sensor, a microphone, a camera (static or video), a keyboard, a button, a mouse, a touch screen, a trackpad, a trackball, an isopoint controller, and / or a voice recognition system.

[0132] One or more output devices 624 are also connected to the interface circuitry 620 of the illustrated example. The output device 624 may 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-plane switching (IPS) display, a touch screen, etc.), a haptic output device, a printer, and / or a speaker. Thus, the interface circuitry 620 of the illustrated example typically includes a graphics driver card, a graphics driver chip, and / or a graphics driver processor.

[0133] The interface circuitry 620 of the illustrated example also includes communication devices, such as a transmitter, a receiver, a transceiver, a modem, a residential gateway, a wireless access point, and / or a network interface, to facilitate data exchange with an external machine (e.g., any type of computing device) via a network 626. The 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.

[0134] The illustrated example of the processor platform 600 also includes one or more mass storage devices 628 for storing software and / or data. Examples of such mass storage devices 628 include a floppy disk drive, a hard disk drive, a compact disk drive, a Blu-ray disk drive, a redundant array of independent disks (RAID) system, and a digital versatile disk (DVD) drive.

[0135] Figure 6 Machine-executable instructions 632 may be stored in the mass storage device 628, in the volatile memory 614, in the non-volatile memory 616, and / or on a removable non-transitory computer-readable storage medium such as a CD or a DVD.

[0136] Figure 7 in the illustrated block diagram that illustrates for Figure 6Example software distribution of the example computer-readable instructions 632 to a third party on the example software distribution platform 705. The example software distribution platform 705 may be implemented by any computer server, data facility, cloud service, etc. capable of storing software and transmitting the software to other computing devices. The third party may be a customer of an entity that owns and / or operates the software distribution platform. For example, the entity that owns and / or operates the software distribution platform may be a developer, seller, and / or licensor of software (such as Figure 6 the example computer-readable instructions 632). The third party may be a consumer, user, retailer, OEM, etc. that purchases and / or licenses the software for use and / or resale and / or sublicense. In the illustrated example, the software distribution platform 705 includes one or more servers and one or more storage devices. The storage device stores Figure 6 the computer-readable instructions 632, which may correspond to the Figure 4 and / or Figure 5 example computer-readable instructions 400, 500 as described above. One or more servers of the example software distribution platform 705 communicate with the network 710, which may correspond to the Internet and / or any one or more of the above example networks. In some examples, one or more servers respond to a request to transmit software to a requester 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 the computer-readable instructions 632 from the software distribution platform 705. For example, software corresponding to the Figure 4 and / or Figure 5 example computer-readable instructions 400, 500 may be downloaded to the example processor platform 600, which will execute the computer-readable instructions 632 to implement the machine-readable LFA generator 102 of FIG. 1 and / or Figure 3 . In some examples, one or more servers of the software distribution platform 705 periodically provide, transmit, and / or enforce updates to the software (e.g., Figure 6 the example computer-readable instructions 632) to ensure that improvements, patches, updates, etc. are distributed and applied to the software at the end-user device.

[0137] Additionally, as discussed 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. Examples disclosed herein include LFA devices that generate electrical signals (e.g., current, voltage, etc.) using various techniques corresponding to test results (e.g., bioelectrochemical cell technology). The electrical signals can be measured and wirelessly provided to a reader without a battery device included in the LFA device. In some examples, the LFA device can determine the test result based on the electrical signal and transmit the result to the reader. The reader can obtain the test result and / or process the electrical signal to determine the test result, and distribute the test result to an external server or database (e.g., via the reader) to provide near real-time data corresponding to the disease and / or spread of the disease.

[0138] Furthermore, the examples disclosed herein provide a mechanism for stopping flow and / or positioning electrodes on an LFA device to obtain stronger electrical signals that can be measured over a longer duration than other diagnostic tests. The examples disclosed herein are also capable of multiplexing, where multiple lines can be used to detect multiple markers (e.g., multiple types of antibodies / antigens) based on a single sample that is difficult or impossible to distinguish with the human eye. Multiplexing has applications, for example, in a single diagnostic test that can test for multiple types of sexually transmitted diseases.

[0139] The example controls disclosed herein also control the run time of the diagnostic test to ensure that the operator does not attempt to obtain results too soon (i.e., before the test is complete), too late, stop the flow too soon, stop the flow too late, etc. This provides further error prevention in obtaining accurate test results. Additionally, 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 being performed in parallel on different LFAs using a single reader), and (c) obtain the electrical signal corresponding to the test result. This provides further error prevention in obtaining multiple tests with overlapping read windows to ensure that the wrong test is not read.

[0140] The examples disclosed herein also include additional information about the test result (lot number, expiration date, shelf life, test information, signal quality information, chain of custody, etc.), all of which can be transmitted together using NFC technology. Traditional methods use additional readers (such as, for example, barcode readers) to read information about the test, which would be supplementary to the optical reader that determines / interprets the test result. Thus, the disclosed examples reduce the number of readers required to obtain a greater amount of information.

[0141] In addition, example rapid diagnostic tests using electronic-based methods have higher sensitivity than conventional visual read tests. In the examples disclosed herein, it is possible to achieve lower detection thresholds using electronic-based techniques compared to what can be achieved when the results are based on operator visual interpretation.

[0142] The examples disclosed herein may include NFC chips that can be encoded and encrypted. If the product label data is adjusted (including, for example, to extend the shelf life) and / or if other modifications are desired, the associated test and manufacturing specific data can subsequently be re-encoded. In some examples, the encoding and / or encryption can be updated and / or configured remotely.

[0143] The examples disclosed herein also apply a potential (e.g., voltage, potentiostat, etc.) to an electrode in contact with the porous medium of the lateral flow assay. Applying the potential and / or voltage helps, facilitates, and / or creates a more favorable environment for bioelectrochemical reactions to occur. In this way, applying the potential and / or voltage increases signal robustness and sensitivity. In some examples, the examples disclosed herein utilize the voltage used to power the wireless chip (e.g., corresponding to the electromagnetic field obtained via the antenna) rather than using a traditional battery to apply the potential and / or voltage. In this way, no battery is required to power the wireless device and / or apply the potential and / or voltage.

[0144] Additionally, the disclosed examples provide a housing that allows a sample to be applied to the lateral flow assay and allows a user or autonomous device to push an electrode into place when the device is ready to be read. The housing may include compartments to hold a buffer and release the buffer onto the sample pad along with the sample. In this way, the user does not need to apply a separate buffer, and the test can be facilitated by simple tasks (e.g., placing a swab in the compartment, sliding a slider, pressing a button), which reduces the risk of user error.

[0145] Examples methods, devices, systems, and articles for manufacturing and / or processing diagnostic test devices are disclosed herein. Additional examples and combinations thereof include the following: Example 1 includes a housing for a lateral flow assay device, the housing including: a first portion including an opening; a second portion coupled to the first portion and housing the lateral flow assay strip, the second portion including a first clamping portion; and a push button located within the opening of the first portion, the push button being movable from a first position to a second position, the push button including a second clamping portion for engaging the first clamping portion of the second portion when moving to the second position to maintain the push button in the second position.

[0146] Example 2 includes the housing of Example 1, wherein when the push button moves to the second position, the push button causes the electrode to contact the lateral flow assay strip.

[0147] Example 3 includes the housing of Example 1, wherein the push button includes a blade to cause cutting or compression of the lateral flow assay strip when the push button is moved to the second position.

[0148] Example 4 includes the housing of Example 1, wherein the push button includes a guide ring and the first part includes a guide post to engage the guide ring.

[0149] Example 5 includes the housing of Example 1, wherein the second part includes ribs to prevent the push button from moving beyond the second position.

[0150] Example 6 includes the housing of Example 1, wherein the push button is to press a printed circuit board layer into contact with the lateral flow assay strip.

[0151] Example 7 includes the housing of Example 6, wherein the printed circuit board layer is made of a flame retardant 4 (FR-4) material.

[0152] Example 8 includes the housing of Example 1, wherein the push button includes a rounded top surface.

[0153] Example 9 includes an assay device comprising: a first part; a second part coupled to the first part, the second part including a first clamping portion; a lateral flow assay strip between the first part and the second part; and a push button movable between a first position and a second position between the first part and the second part, the push button including a second clamping portion for engaging the first clamping portion of the second part when moving to the second position to maintain the button in the second position.

[0154] Example 10 includes the assay device of Example 9, further including a printed circuit board layer, wherein the push button is to press the printed circuit board layer into contact with the lateral flow assay strip when the push button is in the second position.

[0155] Example 11 includes the assay device of Example 9, wherein the push button includes a guide ring and one of the first part or the second part includes a guide post along which the guide ring can slide to prevent tilting of the push button when the push button moves between the first position and the second position.

[0156] Example 12 includes a housing for a lateral flow assay device, the housing comprising: a first part including angled fins; a second part configured to engage the first part and accommodate the lateral flow assay strip; and a slider configured to move from a first position to a second position by engaging the angled fins of the first part.

[0157] Example 13 includes the housing of Example 12, wherein the second part houses electronic devices.

[0158] Example 14 includes the housing of Example 12, wherein the first portion includes a storage space covered by a slider in a second position.

[0159] Example 15 includes the housing of Example 14, wherein the storage space is located above the sample pad of the lateral flow assay strip.

[0160] Example 16 includes the housing of Example 12, wherein the slider is to cause an electrode to contact the lateral flow assay strip when the slider moves to the second position.

[0161] Example 17 includes the housing of Example 12, wherein the slider is to cause cutting or compression of the lateral flow assay strip when the slider moves to the second position.

[0162] Example 18 includes the housing of Example 12, wherein the first portion includes a notch to allow bowing at the center of the first portion.

[0163] Example 19 includes the housing of Example 12, wherein the slider includes angled edges to engage angled fins.

[0164] Example 20 includes the housing of Example 19, wherein a first slope of the angled edge is complementary to a second slope of the angled fin.

[0165] Example 21 includes the housing of Example 20, wherein movement of the slider from the first position to the second position causes the angled edge to push the angled fin to cause an electrode to contact the lateral flow assay strip.

[0166] Example 22 includes the housing of Example 12 and further includes a printed circuit board layer having a bridge spaced from the sample pad of the lateral flow assay device.

[0167] Example 23 includes the housing of Example 12, wherein the first portion further includes a flow restrictor to perform at least one of cutting or pressing on a portion of the lateral flow assay strip when the slider moves to the second position.

[0168] Example 24 includes a lateral flow assay device that includes: a conjugate pad that includes a conjugate corresponding to a target analyte in a biological sample, the conjugate being labeled with an enzyme; a porous medium that includes a first zone and a second zone, the first zone including at least one of an immobilized antigen corresponding to the target analyte or an immobilized antibody corresponding to the target analyte, the second zone being laterally displaced from the first zone along a longitudinal axis of the lateral flow assay device, and the porous medium transmitting the flow of the biological sample, the conjugate with the enzyme, and a liquid buffer along the porous medium; a holding member that includes an enzyme substrate; a first electrode that is configured to contact the porous medium in the first zone; and a second electrode that is configured to contact the porous medium in the second zone, the first electrode and the second electrode being configured to detect an electrical signal when the target analyte is present in the biological sample and the enzyme reacts with the enzyme substrate.

[0169] Example 25 includes the lateral flow assay device of Example 24, wherein the holding member is configured to dissolve in response to exposure to at least one of the biological sample or the liquid buffer.

[0170] Example 26 includes the lateral flow assay device of Example 24, wherein the holding member is configured to release the enzyme substrate.

[0171] Example 27 includes the lateral flow assay device of Example 24, wherein the holding member is configured to release the enzyme substrate after application of a buffer.

[0172] Example 28 includes the lateral flow assay device of Example 24, wherein the holding member is configured to release the enzyme substrate in response to an action taken by a user.

[0173] Example 29 includes the lateral flow assay device of Example 24, wherein the enzyme is glucose oxidase and the enzyme substrate is glucose.

[0174] Example 30 includes the lateral flow assay device of Example 29, wherein glucose oxidase reacts with glucose to produce hydrogen peroxide, and the hydrogen peroxide reacts with the metal of the first electrode to produce an electrical signal.

[0175] Example 31 includes a device for use with a fluid sample, the device including: a sample pad; a porous medium in contact with the sample pad; a holding member configured to (a) hold glucose and (b) release the glucose; an electrode; and a mechanical member configured to move the electrode from a first position to a second position, the electrode being in contact with the porous medium in the second position.

[0176] Example 32 includes the device of Example 31, wherein the mechanical member is a switch.

[0177] Example 33 includes the device of Example 31, wherein the mechanical member causes the holding member to release glucose.

[0178] Example 34 includes the device of Example 31, wherein the holding member is to be dissolved to release glucose.

[0179] Example 35 includes the device of Example 31, wherein the porous medium includes a region that includes at least one of an immobilized antigen corresponding to the target analyte or an immobilized antibody corresponding to the target analyte.

[0180] Example 36 includes the device of Example 35, wherein when the target analyte is present in the sample, glucose oxidase attaches to the region, and the released glucose is used to react with glucose oxidase to generate hydrogen peroxide, and the hydrogen peroxide is used to react with the metal of the electrode to generate an electrical signal.

[0181] Example 37 includes a non-visual indicating biosensor that includes: a conjugate pad that includes a conjugate to attach to a target analyte in a biological sample, the conjugate being labeled with an enzyme; a porous medium that has a first end and a second end, the conjugate pad being coupled to the first end of the porous medium; at least one of an immobilized antigen corresponding to the target analyte or an immobilized antibody corresponding to the target analyte, which is coupled to the porous medium between the first end and the second end; a holding member that is used to release an enzyme substrate; the porous medium implements a bioelectrochemical cell between the first end and the second end downstream of the at least one of the immobilized antigen or the immobilized antibody, the bioelectrochemical cell being used to generate an electrical signal based on the reaction between the released enzyme substrate and the enzyme when the target analyte is present in the biological sample; and a wicking pad that is used to draw fluid along the porous medium.

[0182] Example 38 includes the non-visual indicating biosensor of Example 37, and further includes: an electrode; and a switch that is used to move the electrode to one of a first position and a second position.

[0183] Example 39 includes the non-visual indicating biosensor of Example 38, wherein when the switch is placed in the second position, it causes the holding member to release the enzyme substrate.

[0184] Example 40 includes the non-visual indicating biosensor of Example 37, wherein the holding member is to be dissolved to release the enzyme substrate.

[0185] Example 41 includes the non-visual indicating biosensor of Example 37, wherein the enzyme is glucose oxidase and the enzyme substrate is glucose.

[0186] Example 42 includes the non-visual indicating biosensor of Example 41, wherein glucose oxidase reacts with glucose to generate hydrogen peroxide, and the hydrogen peroxide is used to react with the metal of the electrode to generate an electrical signal.

[0187] Example 43 includes a lateral flow assay that includes: a porous medium; and a holding member that includes an enzyme substrate that is configured to react with an enzyme immobilized on the porous medium to generate a product when a target analyte is present in a sample applied to the porous medium; and an electrode that is configured to react with the product to generate an electrical signal.

[0188] Example 44 includes the lateral flow assay of Example 43, wherein the holding member is configured to release the enzyme substrate upon rupture or dissolution.

[0189] Example 45 includes the lateral flow assay of Example 43, wherein the enzyme is glucose oxidase, the enzyme substrate is glucose, and the product is hydrogen peroxide.

[0190] As used herein, the descriptors "first," "second," "third," etc. are used when identifying multiple elements or components that may be referred to individually. Unless otherwise specified or understood based on their context of use, such descriptors are not intended to impart any meaning of priority, physical order or arrangement in a list, or temporal ordering, but are merely used as labels to refer to multiple elements or components individually to facilitate understanding of the disclosed examples. In some examples, the descriptor "first" may be used to refer to an element in a particular embodiment, while the same element may be referred to in the claims using a different descriptor such as "second" or "third." In such cases, it should be understood that such descriptors are merely used for convenience in referring to multiple elements or components.

[0191] "Comprising" and "including" (and all forms and tenses thereof) are used herein as open-ended terms. Thus, whenever a claim employs any form of "comprising" or "including" (e.g., comprises, includes, comprising, including, having, etc.) as a preamble or within any kind of claim recitation, it will be understood that additional elements, terms, etc. may exist without falling outside the scope of the corresponding claim or recitation. As used herein, when the phrase "at least" is used as a transitional term in, for example, the preamble of a claim, it is open-ended in the same manner as the terms "comprising" and "including" are open-ended. When used in the form of, for example, A, B, and / or C, the term "and / or" means any combination or subset of A, B, C, such as (1) only A, (2) only B, (3) only C, (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 a structure, component, article, object, and / or thing, the phrase "at least one of A and B" is intended to mean implementations that include (1) at least one A, (2) at least one B, and (3) any one of at least one A and at least one B. Similarly, as used herein in the context of describing a structure, component, article, object, and / or thing, the phrase "at least one of A or B" is intended to mean implementations that include (1) at least one A, (2) at least one B, and (3) any one of at least one A and at least one B. As used herein in the context of describing the performance or execution of a process, instruction, action, activity, and / or step, the phrase "at least one of A and B" is intended to mean implementations that include (1) at least one A, (2) at least one B, and (3) any one of at least one A and at least one B. Similarly, as used herein in the context of describing the performance or execution of a process, instruction, action, activity, and / or step, the phrase "at least one of A or B" is intended to mean implementations that include (1) at least one A, (2) at least one B, and (3) any one of at least one A and at least one B.

[0192] As used herein, singular references (e.g., "a," "an," "first," "second," etc.) do not exclude a plurality. As used herein, the term "a" or "an" entity refers to one or more of that entity. The terms "a" (or "an"), "one or more," and "at least one" are used interchangeably herein. Additionally, although multiple devices, elements, or method acts may be implemented by, for example, a single unit or processor, they are listed separately. Further, 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 imply that a combination of features is not feasible and / or advantageous.

[0193] The appended claims are hereby incorporated into this detailed description by this reference, where each claim independently serves as a separate embodiment of the present disclosure.

Claims

1. A housing for a lateral flow assay device, comprising: A first part, the first part including an opening; A second part, the second part being coupled to the first part and accommodating a lateral flow assay strip, the second part including a first clamping portion; And A push button, the push button being located within the opening of the first part, the push button being movable from a first position to a second position, the push button including a second clamping portion for engaging the first clamping portion of the second part when moving to the second position to maintain the push button in the second position.

2. The housing according to claim 1, wherein When the push button moves to the second position, the push button is to cause an electrode to contact the lateral flow assay strip.

3. The housing according to claim 1, wherein, The push button includes a blade to cause cutting or compression of the lateral flow assay strip when the push button moves to the second position.

4. The housing according to claim 1, wherein: The push button includes a guide ring; and The first part includes a guide post to engage the guide ring.

5. The housing according to claim 1, wherein, The second part includes ribs to prevent the push button from moving beyond the second position.

6. The housing according to claim 1, wherein, The push button is to press a printed circuit board layer into contact with the lateral flow assay strip.

7. The housing according to claim 6, wherein, The printed circuit board layer is made of a flame retardant 4 (FR-4) material.

8. The housing according to claim 1, wherein, The push button includes a rounded top surface.

9. An assay device, comprising: A first part; A second part, the second part being coupled to the first part, the second part including a first clamping portion; A lateral flow assay strip, the lateral flow assay strip being between the first part and the second part; And A push button, the push button being movable between the first part and the second part from a first position to a second position, the push button including a second clamping portion for engaging the first clamping portion of the second part when moving to the second position to maintain the push button in the second position.

10. The measuring device according to claim 9 further includes a printed circuit board layer, wherein, The push button is to press the printed circuit board layer into contact with the lateral flow assay strip when the push button is in the second position.

11. The measuring device according to claim 9, wherein, The push button includes a guide ring, and one of the first part or the second part includes a guide post, and the guide ring is slidable along the guide post to prevent tilting of the push button when the push button moves between the first position and the second position.

12. A housing for a lateral flow assay device, comprising: A first part, the first part including angled fins; A second part, the second part being configured to engage the first part and accommodate a lateral flow assay strip; And A slider, the slider being configured to move from a first position to a second position by engaging the angled fins of the first part.

13. The housing according to claim 12, wherein, The second part houses electronic devices.

14. The housing according to claim 12, wherein, The first part includes a storage space covered by the slider in the second position.

15. The housing according to claim 14, wherein, The storage space is located above the sample pad of the lateral flow assay strip.

16. The housing according to claim 12, wherein, The slider is to cause an electrode to contact the lateral flow assay strip when the slider moves to the second position.

17. The housing according to claim 12, wherein, The slider is to cause cutting or compression of the lateral flow assay strip when the slider moves to the second position.

18. The housing according to claim 12, wherein, The first portion includes a cutout to allow warping at the center of the first portion.

19. The housing according to claim 12, wherein, The slider includes an angled edge to engage the angled fin.

20. The housing according to claim 19, wherein, A first slope of the angled edge is complementary to a second slope of the angled fin.

21. The housing according to claim 20, wherein, Movement of the slider from the first position to the second position causes the angled edge to push the angled fin to cause the electrode to contact the lateral flow assay strip.

22. The housing according to claim 12, further comprising a printed circuit board layer having a bridge spaced from the sample pad of the lateral flow device.

23. The housing according to claim 12, wherein, The first portion further includes a flow restrictor to perform at least one of cutting or pressing a portion of the lateral flow assay strip when the slider moves to the second position.

24. A lateral flow device, comprising: a conjugate pad comprising a conjugate corresponding to a target analyte in a biological sample, the conjugate being labeled with an enzyme; a porous medium comprising a first zone and a second zone, the first zone comprising at least one of an immobilized antigen corresponding to the target analyte or an immobilized antibody corresponding to the target analyte, the second zone being laterally displaced from the first zone along a longitudinal axis of the lateral flow device, and the porous medium propagating a flow of the biological sample, the conjugate with the enzyme, and a liquid buffer along the porous medium, a holding member comprising an enzyme substrate; a first electrode for contacting the porous medium in the first zone; and a second electrode for contacting the porous medium in the second zone, the first electrode and the second electrode for detecting an electrical signal when the target analyte is present in the biological sample and the enzyme reacts with the enzyme substrate.

25. The lateral flow assay device according to claim 24, wherein, The holding member is to dissolve in response to exposure to at least one of the biological sample or the liquid buffer.

26. The lateral flow assay device according to claim 24, wherein, The holding member is to release the enzyme substrate.

27. The lateral flow assay device according to claim 24, wherein, The holding member is to release the enzyme substrate after application of a buffer.

28. The lateral flow assay device according to claim 24, wherein, The holding member is to release the enzyme substrate in response to an action taken by a user.

29. The lateral flow assay device according to claim 24, wherein, The enzyme is glucose oxidase and the enzyme substrate is glucose.

30. The lateral flow assay device according to claim 29, wherein, The glucose oxidase reacts with the glucose to produce hydrogen peroxide, and the hydrogen peroxide reacts with the metal of the first electrode to produce the electrical signal.

31. A device for use with a fluid sample, the device comprising: a sample pad; a porous medium in contact with the sample pad; a holding member for (a) holding glucose and (b) releasing the glucose; an electrode; and a mechanical component for moving the electrode from a first position to a second position, the electrode to contact the porous medium in the second position.

32. The device according to claim 31, wherein, The mechanical component is a switch.

33. The apparatus according to claim 31, wherein, The mechanical component causes the holding member to release the glucose.

34. The apparatus according to claim 31, wherein, The holding member is to dissolve to release the glucose.

35. The device according to claim 31, wherein, The porous medium includes a zone that includes at least one of an immobilized antigen corresponding to a target analyte or an immobilized antibody corresponding to the target analyte.

36. The device according to claim 35, wherein, When the target analyte is present in the sample, glucose oxidase attaches to the zone, and the released glucose is used to react with the glucose oxidase to generate hydrogen peroxide, and the hydrogen peroxide is used to react with the metal of the electrode to generate an electrical signal.

37. A non-visual indicating biosensor, comprising: a conjugate pad that includes a conjugate for attaching to a target analyte in a biological sample, the conjugate being labeled with an enzyme; a porous medium having a first end and a second end, the conjugate pad being coupled to the first end of the porous medium; at least one of an immobilized antigen corresponding to the target analyte or an immobilized antibody corresponding to the target analyte, which is coupled to the porous medium between the first end and the second end; a holding member for releasing an enzyme substrate; the porous medium implements a bioelectrochemical cell between the first end and the second end downstream of at least one of the immobilized antigen or the immobilized antibody, the bioelectrochemical cell being configured to generate an electrical signal based on a reaction between the released enzyme substrate and the enzyme when the target analyte is present in the biological sample; and a wicking pad for wicking fluid along the porous medium.

38. The non-visual indicating biosensor according to claim 37, further comprising: an electrode; and a switch for moving the electrode to one of a first position and a second position.

39. The non-visual indication biosensor according to claim 38, wherein, The switch causes the holding member to release the enzyme substrate when placed in the second position.

40. The non-visual indication biosensor according to claim 37, wherein, The holding member is to be dissolved to release the enzyme substrate.

41. The non-visual indication biosensor according to claim 37, wherein, The enzyme is glucose oxidase, and the enzyme substrate is glucose.

42. The non-visual indication biosensor according to claim 41, wherein, The glucose oxidase reacts with the glucose to generate hydrogen peroxide, and the hydrogen peroxide is used to react with the metal of the electrode to generate the electrical signal.

43. A lateral flow assay, comprising: a porous medium; and a holding member that includes an enzyme substrate that is used to react with an enzyme immobilized on the porous medium to generate a product when a target analyte is present in a sample applied to the porous medium; and an electrode for reacting with the product to generate an electrical signal.

44. The lateral flow assay according to claim 43, wherein, The holding member is to release the enzyme substrate upon rupture or dissolution.

45. The lateral flow assay according to claim 43, wherein, The enzyme is glucose oxidase, the enzyme substrate is glucose, and the product is hydrogen peroxide.

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