Sensing apparatus for monitoring one or more analytes in a sample

Abstract

Embodiments of the present invention provide a sensing apparatus. The sensing apparatus includes a biochip unit and a receptacle device. The biochip unit includes a reservoir configured to receive a predetermined amount of an analyte, a plurality of working electrodes configured to be in contact with the analyte, a reference electrode and a counter electrode configured to complete an electrical circuit with the plurality of working electrodes. The receptacle device includes a receptacle unit configured to be electrically and mechanically coupled to the biochip unit, a function generator electrically coupled to the receptacle unit, a memory unit configured to store machine-readable instructions, and a processor operably connected to the memory unit. The processor is enabled by the machine-readable instructions to determine a plurality of deduced values corresponding to a plurality of analyte parameters of the analyte from the plurality of observed values of the plurality of predetermined parameters.

Description

TECHNICAL FIELD

[001] The present invention relates generally to electroanalytical chemistry. More specifically, the present invention relates to the determination of characteristics of analytes through observing changes occurring in an electrochemical system on the introduction of the analytes in the electrochemical system. BACKGROUND ART

[002] Electrochemistry constitutes a specialized area within physical chemistry, dedicated to the investigation of the interplay between electrical energy and chemical transformations. Traditional electrochemical approaches employ a diverse range of methodologies, including but not limited to potentiometry, voltammetry, and amperometry. Each technique comes with its specific limitations and application scopes.

[003] The fundamental components indispensable for an electrochemical analysis encompass 1) an electrochemical cell, 2) electrodes, generally including a counter, reference, and working electrode, 3) an electrolyte solution, 4) a measurement instrument, 5) a power source, 6) a controlled environment, and 7) analysis software. However, these traditional systems often necessitate sizable sample volumes, specialized apparatus, and extensive analysis time. Moreover, they are generally limited to the analysis of a single analyte, an inherent shortcoming when real-time, multifaceted biological analyses are imperative.

[004] Therefore, there is a need for a sensing apparatus that overcomes the disadvantages and limitations associated with the prior art and provides a more satisfactory solution. OBJECTS OF THE INVENTION

[005] Some of the objects of the invention are as follows:

[006] An object of the present invention is to provide a sensing apparatus that is capable of determining the characteristics of an analyte to identify several different biomarkers with a volume of the analyte being relatively minuscule (01 pL to 200 pL);

[007] Another object of the present invention is to provide a sensing apparatus that has a plurality of working electrodes for sensing several different biomarkers present in an analyte, simultaneously;

[008] Another object of the invention is to enable at least one working electrode of the plurality of working electrodes to sense background noise, such that, the background noise may then be subtracted from the measurements made by other sensing electrodes to provide more accurate measurements;

[009] Another object of the present invention is to provide a sensing apparatus that can deploy several different electroanalytical chemistry techniques for the determination of several different characteristics of an analyte. Such techniques may include, but are not limited to, cyclic voltammetry, square wave voltammetry, Electrochemical Impedance Spectroscopy (EIS), Conductometric voltammetry , Differential Pulse Voltammetry etc;

[010] Another object of the present invention is to provide a sensing apparatus that is compatible with several different bio-sensing mediums (such as molecular probes, ion-selective membranes, enzymes, and DNA / RNA / XNA probes), where the bio-sensing mediums can be bonded with sensing portions of the working electrodes;

[011] Another object of the present invention is to provide a sensing apparatus that is capable of generating test signals of several different waveforms such as linear, triangular, square wave, sine wave, white noise, etc., and apply the test signals to the sensing electrodes and a control electrode that enables establishing of a baseline;

[012] Another object of the present invention is to provide a sensing apparatus that is capable of providing programmable amplification to a voltage or a current signal received from the sensing electrodes; and

[013] It is also an object of the present invention to provide a sensing apparatus that is capable of eliminating errors caused due to several external factors such as temperature variation, humidity, sunlight or internal factors such as presence of a fluid film on the sensing electrodes, difference in conductivity or interfering analytes within the sample. The errors are envisaged to be eliminated by implementing a Machine Learning (ML) algorithm trained on a dataset of a large number of known characteristics of the analyte observed in correlation with known variations in characteristics of the electrochemical system on introduction of the analyte into the electrochemical system. SUMMARY OF THE INVENTION

[014] According to a first aspect of the present invention, there is provided a sensing apparatus. The sensing apparatus comprises a biochip unit having a reservoir to pour a sample containing the one or more analyte; a plurality of working electrode configured to be in contact with the one or more analyte; a receptacle device configured to be electrically and mechanically connected to the biochip unit; a function generator configured to generate a plurality of test signals of a plurality of predetermined parameters; wherein the function generator transmits one or more test signals to the plurality of working electrodes and determine a plurality of observed values of the plurality of predetermined parameters using the plurality of working electrodes in response to the one or more test signals; wherein the sensing apparatus determine an amount of the one or more analyte in contact with the plurality of working electrode.

[015] In one embodiment of the invention, the sensing apparatus further comprising a reference electrode and a counter electrode.

[016] In one embodiment of the invention, one of the plurality of working electrode is configured to sense background noise.

[017] In one embodiment of the invention, the plurality of working electrode is connected to a plurality of multiplexer circuit.

[018] In one embodiment of the invention, the one or more test signal comprises Linear Sweep Voltametry (LSW), Cyclic Voltametry (CV), Square Wave Voltametry (SWV), Differential Pulse Voltametry (DPV), Normal Pulse Voltametry (NPV), Electrochemical Impedance Spectroscopy (EIS), Reverse Pulse Voltametry (RPV), Differential Square Wave Voltametry (d-SWV), Amperometry, Potentiometry, Chrono-amperometry, Anodic Stripping Voltametry, Dielectric Spectroscopy.

[019] In one embodiment of the invention, the plurality of predetermined parameters includes current resulting from an applied potential, differential current peak value, ohmic resistance of an electrolyte solution, a constant phase element, Warburg impedance, charge transfer resistance, and non-linear combinations.

[020] In one embodiment of the invention, the sensing apparatus further comprising a control circuity comprising a processor, a memory unit and a storage device, the control circuitry is configured to generate an analytic result.

[021] In one embodiment of the invention, the sensing apparatus further comprising an automated programmable gain amplifier for automated sensitivity adjustment for required range of detection.

[022] In one embodiment of the invention, the sensing apparats is configured to connect wirelessly with an external device.

[023] In one embodiment of the invention, the sensing apparatus is provided with a machine learning capability that includes but is not limited to in-situ principal analytes analysis for enhancing signal interpretation for detecting the amount of the analyte and detection of anomaly.

[024] According to a second aspect of the present invention, there is provided a method for determining a plurality of deduced values corresponding to a plurality of analyte parameters of an analyte, using a sensing apparatus. The method comprises: providing a biochip unit having a reservoir to pour a sample containing the one or more analyte, the biochip unit having a plurality of working electrode configured to be in contact with the one or more analyte; providing a receptacle device configured to be electrically and mechanically connected to the biochip unit; generating a plurality of test signals of a plurality of predetermined parameters by a function generator; wherein the function generator transmits one or more test signals to the plurality of working electrodes and determine a plurality of observed values of the plurality of predetermined parameters using the plurality of working electrodes in response to the one or more test signals; wherein the sensing apparatus determine an amount of the one or more analyte in contact with the plurality of working electrode in one embodiment of the invention, the sensing apparatus further includes a Programmable Gain Amplifier (PGA).

[025] In one embodiment of the invention, one or more sensing electrode comprises a plurality of working electrode, and background sensing electrode.

[026] In one embodiment of the invention, one of the plurality of working electrode is configured to sense background noise.

[027] In one embodiment of the invention, the plurality of working electrode is connected to a plurality of multiplexer circuit.

[028] In one embodiment of the invention, the one or more test signal comprises Linear Sweep Voltametry (LSW), Cyclic Voltametry (CV), Square Wave Voltametry (SWV), Differential Pulse Voltametry (DPV), Normal Pulse Voltametry (NPV), Electrochemical Impedance Spectroscopy (EIS), Reverse Pulse Voltametry (RPV), Differential Square Wave Voltametry (d-SWV), Amperometry, Potentiometry, Chrono-amperometry, Anodic Stripping Voltametry, Dielectric Spectroscopy.

[029] In one embodiment of the invention, the plurality of predetermined parameters includes current resulting from an applied potential, differential current peak value, ohmic resistance of an electrolyte solution, a constant phase element, Warburg impedance, charge transfer resistance, and non-linear combinations.

[030] In one embodiment of the invention, the receptacle unit is provided with a control circuity comprising a processor, a memory unit and a storage device, the control circuitry is configured to generate an analytic result.

[031] In one embodiment of the invention, the method further comprising using an automated programmable gain amplifier for automated sensitivity adjustment for required range of detection.

[032] In one embodiment of the invention, the method comprises connecting the biochip unit wirelessly with an external device.

[033] In one embodiment of the invention, the method uses a machine learning capability that includes but is not limited to in-situ principal analytes analysis for enhancing signal interpretation for detecting the amount of the analyte and detection of anomaly.

[034] In the context of the specification, the term “analyte” refers to the substance or the chemical species that is being analyzed or measured using electroanalytical techniques. The analyte is the specific component of interest whose concentration or properties are being investigated through its interaction with electrodes and electrical signals. The investigation could include the determination of concentration, identification of the substance, or characterization of its electrochemical properties. Analytes in electroanalytical chemistry can range from ions to complex molecules, depending on the specific application and analytical goals. Some of the substances commonly used as the analytes include single molecules, ions, metabolites, proteins, peptides, vesicles, oligonucleotides, viral particles, prokaryotic cells, and eukaryotic cells.

[035] In the context of the specification, the term “working electrode” refers to the electrode where the electrochemical reaction of interest occurs. The working electrode is the site where the analyte is detected in correlation to the changes observed according to the electrochemical technique used. The choice of working electrode material depends on the specific analyte and the desired electrochemical technique. Common working electrode materials include gold, platinum, glassy carbon, graphene, carbon nanotubes, and mercury. The working electrode may be fabricated by several techniques such as screen printing, drop-casting, sputtering or electro-deposition

[036] In the context of the specification, the term “counter electrode” also known as “auxiliary electrode” refers to a balancing electrode. The counter electrode provides the electrons required for the electrochemical reaction at the working electrode. The counter electrode typically has a larger surface area to facilitate the flow of electrons. Common counter electrode materials include gold, platinum, stainless steel, and graphite.

[037] In the context of the specification, the term “reference electrode” refers to the electrode that serves as a stable potential reference for the electrochemical cell. The reference electrode maintains a constant potential that is independent of the current flowing through the cell. This allows for accurate measurement of the potential of the working electrode. Common reference electrodes include calomel electrodes, silver / silver chloride electrodes, and mercury / mercurous sulphate electrodes.

[038] In the context of the specification, the term “molecular probe” refers to a small molecule or macromolecule that specifically binds to a target molecule or structure. They are used in a variety of molecular biology and chemistry techniques to study the properties of the target molecules or structures. The most commonly used types of molecular probes include nucleic acid probes (single stranded DNA, XNA or RNA molecules), antibody probes (specific to corresponding antigens), and small molecule probes (that bind through non-covalent interactions). The binding of the molecular probes may be detected through radioactivity, fluorescence, and enzyme activity.

[039] In the context of the specification, the term “processor” refers to one or more of a microprocessor, a microcontroller, a general-purpose processor, a Field Programmable Gate Array (FPGA) or an Application Specific Integrated Circuit (ASIC), and the like.

[040] In the context of the specification, the phrase “memory unit” refers to volatile storage memory, such as Static Random Access Memory (SRAM) and Dynamic Random Access Memory (DRAM) of types such as Asynchronous DRAM, Synchronous DRAM, Double Data Rate SDRAM, Rambus DRAM, and Cache DRAM, etc.

[041] In the context of the specification, the phrase “storage device” refers to a nonvolatile storage memory such as EPROM, EEPROM, flash memory, or the like.

[042] In the context of the specification, the phrase “communication interface” refers to a device or a module enabling direct connectivity via wires and connectors such as USB, HDMI, VGA, or wireless connectivity such as Bluetooth or Wi-Fi, or Local Area Network (LAN) or Wide Area Network (WAN) implemented through TCP / IP, IEEE 802.x, GSM, CDMA, LTE, or other equivalent protocols.

[043] In the context of the specification, the phrase “communication network” refers to a group of several connected devices including computing devices (such as desktops, mobile handheld devices, tablet PCs, notebooks, etc.), local and remotely located servers (such as web servers, application servers, database servers, Application Program Interface (API) servers, load balancers, compute nodes, and the like), routers, antennas, modems, multiplexers, demultiplexers, and the like. In that regard, the aforementioned connected devices may be able to exchange data signals through wired and / or wireless means as per several combinations of several different communication protocols such as 802.11 (Wi-Fi), 802.3 (Ethernet), Bluetooth, NFC, ZigBee and 3GPP protocols such as HSPA, HSDPA, LTE, GSM, CDMA, WLL and the like. BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

[044] The accompanying drawings illustrate the best mode for carrying out the invention as presently contemplated and set forth hereinafter. The present invention may be more clearly understood from a consideration of the following detailed description of the preferred embodiments taken in conjunction with the accompanying drawings wherein like reference letters and numerals indicate the corresponding parts in various figures in the accompanying drawings, and in which:

[045] FIG. 1A illustrates a sensing apparatus for an electrochemical system, in accordance with an embodiment of the present invention;

[046] FIG. 1B illustrates a segment of a circuitry of the sensing apparatus, in accordance with an embodiment of the present invention;

[047] FIG. 1C illustrates an example representation of a circuit at a surface of a working electrode, in accordance with an embodiment of the present invention;

[048] FIG. 1D illustrates a comparison between a working electrode measuring background noise and a working electrode analyzing a target analyte, in accordance with an embodiment of the present invention;

[049] FIG 1E. illustrates a reference electrode of the sensing apparatus, in accordance with an embodiment of the present invention;

[050] FIG. 1F illustrates an adaptation of the sensing apparatus for the prevention of loss of solvent, in accordance with an embodiment of the present invention;

[051] FIG. 1G illustrates a plurality of working electrodes connected to a processor through a multiplexer, in accordance with an embodiment of the present invention;

[052] FIG. 2 illustrates a method for determining a plurality of deduced values corresponding to a plurality of analyte parameters of an analyte, using the sensing apparatus, in accordance with an embodiment of the present invention;

[053] FIG. 3 illustrates a method for training an ML algorithm for the determination of the plurality of deduced values corresponding to the plurality of respective analyte parameters of the analyte;

[054] FIG 4A illustrates a perspective view of an example receptacle device of the sensing apparatus, in accordance with an embodiment of the present invention;

[055] FIG. 4B illustrates an exploded view of the example receptacle device of FIG. 4A;

[056] FIG. 5A illustrates a top view of an example biochip unit of the sensing apparatus, in accordance with an embodiment of the present invention;

[057] FIG. 5B illustrates a bottom view of the example biochip unit of FIG. 5A;

[058] FIG. 6A illustrates a perspective view of an example receptacle unit of the receptacle device, in accordance with an embodiment of the present invention;

[059] FIG. 6B illustrates a top perspective view of the biochip unit, in accordance with an embodiment of the present invention; and

[060] FIG. 6C illustrates a perspective view of an assembly of the receptacle unit of FIG. 6A and biochip unit of FIG. 6B.

[061] FIG. 7A illustrates a configuration of the biochip unit in accordance with an exemplary embodiment of the present invention.

[062] FIG. 7B illustrates another configuration of the biochip unit in accordance with an exemplary embodiment of the present invention.

[063] FIG. 7C illustrates another configuration of the biochip unit in accordance with an exemplary embodiment of the present invention.

[064] FIG. 7D illustrates another configuration of the biochip unit in accordance with an exemplary embodiment of the present invention.

[065] FIG. 8 shows a sensing apparatus with biochip receptacle unit in accordance with an embodiment of the present invention. DETAILED DESCRIPTION

[066] Embodiments of the present invention disclosure will be described more fully hereinafter with reference to the accompanying drawings in which like numerals represent like elements throughout the figures, and in which example embodiments are shown.

[067] The detailed description and the accompanying drawings illustrate the specific exemplary embodiments by which the disclosure may be practiced. These embodiments are described in detail to enable those skilled in the art to practice the invention illustrated in the disclosure. It is to be understood that other embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the present disclosure. The following detailed description is therefore not to be taken in a limiting sense, and the scope of the present invention disclosure is defined by the appended claims. Embodiments of the claims may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein.

[068] Embodiments of the present invention provide a sensing apparatus (hereinafter also referred to as “the apparatus”) for an electrochemical system. The sensing apparatus is designed to deploy several electroanalytical techniques including Linear Sweep Voltametry (LSW), Cyclic Voltametry (CV), Square Wave Voltametry (SWV), Differential Pulse Voltametry (DPV), Normal Pulse Voltametry (NPV), Electrochemical Impedance Spectroscopy (EIS), Reverse Pulse Voltametry (RPV), Differential Square Wave Voltametry (d-SWV), Amperometry, Potentiometry, Chrono-amperometry, Anodic Stripping Voltametry, Dielectric Spectroscopy, and the like to study properties of solid or fluid-based analytes. Several embodiments of the sensing apparatus can be used for determining the properties of several analytes taken as biological sensors to determine biomarkers such as blood glucose levels and the presence of specific antibodies. In that regard, the apparatus includes a reservoir containing an electrolyte to receive a predetermined volume of an analyte. The introduction of an analyte is envisaged to modify electrochemical properties, such as the impedance or magnitude of the faradaic current of the sensing apparatus.

[069] The differential introduced in the electrochemical properties of the sensing apparatus may then be utilized for the identification of constituents of analytes and several other inherent properties, such as concentration of glucose, type of antibody, concentration of cancer biomarkers, etc. of the identified constituents. In that regard, the sensing apparatus is further envisaged to be provided with at least three electrodes, viz., a working electrode, a reference electrode, and a counter electrode at least partially submerged in an electrolyte. The electrolyte may be a solution, a single solid substance, or a mixture of several different solutions or solid substances. In several alternate embodiments of the invention, the sensing apparatus may include several working electrodes, enabling the sensing apparatus to test the analyte for several respective biomarkers in a physiological testing and diagnostic scenario. While the current flows between the working electrode and the counter electrode, the reference electrode is used to maintain accuracy in regard to the applied potential relative to a stable reference reaction. Moreover, a working electrode for sensing background noise helps in the determination of what the background noise constitutes. The background noise is then subtracted from observed values of any given working electrode according to the ML training model parameters.

[070] The sensing apparatus further includes a function generator capable of generating test signals of known characteristics depending upon which electroanalytical technique is being deployed. The sensing apparatus has also been provided with a control circuitry including a processor, a memory unit and / or a storage device, and a communication interface enabling the sensing apparatus to deconvolute complex electrochemical signals and generate results that can be directly interpreted by a user who may be a layman, a chemist, a healthcare service provider, or any other person. Furthermore, the microcontroller / processor on the device may be configured to receive new protocols, software updates, algorithms, etc. through the communication interface or over-the-air (OTA). During operation, the function generator may apply several test signals to the working electrode through the counter electrode, while the reference electrode is maintained at a stable potential. Electrical current in a specific part of the circuit or potential difference between two predetermined points may then be measured using the working electrode for sensing the background noise, to interpret the several different characteristics of the analyte.

[071] The measurements made by the sensing apparatus may be stored remotely in a cloud-based database for future references, through the communication interface connected with a communication network. The cloud database and / or a database server may be used to facilitate transfer software / firmware updates, configuration data, and flowcharts to the sensing apparatus. In several embodiments, the cloud database may be connected to several sensing apparatuses associated with several different users. Data obtained from the several different apparatuses may anonymized and stored in data tables and data structures for anthropological research, regional health policy development, drug development, and development of newer software / firmware / hardware associated with the sensing apparatus. In several embodiments, the sensing apparatus may be able to communicate through the communication interface and the communication network with a generative Artificial Intelligence (Al) server implementing a generative Al tool. The communication with the generative Al server would allow the measurements made by the sensing apparatus to be transmitted to the generative Al server and interpretation of the measurements be generated by the generative Al tool. The interpretation of the measurements may then be presented to the user without needing a trained clinician or a healthcare service provider to perform the same job.

[072] In an embodiment of the present invention, there is provided a sensing apparatus. The sensing apparatus includes a biochip unit. The biochip unit includes a reservoir in an upper biochip portion, the reservoir defined by an upper biochip surface and a cover layer, the reservoir configured to receive a predetermined amount of an analyte. The biochip unit further includes a plurality of working electrodes provided on the upper biochip surface, the plurality of working electrodes configured to be in contact with the analyte. Furthermore, the biochip unit includes a central ring with a central hole therebetween configured to create a gap between the cover layer and the upper biochip surface, thereby enabling the predetermined amount of the analyte to fill up the reservoir, over the plurality of working electrodes, through capillary action. The biochip unit also includes a counter electrode configured to complete an electrical circuit with the plurality of working electrodes. The sensing apparatus further includes a receptacle device. The receptacle device includes a receptacle unit configured to be electrically and mechanically coupled to the biochip unit. The receptacle device further includes a function generator electrically coupled to the receptacle unit, the function generator configured to generate a plurality of test signals of a plurality of respective predetermined characteristics. Furthermore, the receptacle device includes a storage device configured to store data generated internally and / or received from a data resource. The receptacle device further includes a memory unit configured to store machine-readable instructions. The receptacle device further includes a processor operably connected to the memory unit. The machine-readable instructions when executed by the processor, enable the processor to generate, using the function generator, one or more test signals, and transmit the one or more test signals to the plurality of working electrodes, determine a plurality of observed values of a plurality of respective predetermined parameters, using the plurality of working electrodes, in response to the one or more test signals and presence of the at least the part of the predetermined amount of the analyte in contact with the plurality of working electrodes, and determine a plurality of deduced values corresponding to a plurality of analyte parameters of the analyte from the plurality of observed values of the plurality of predetermined parameters.

[073] In the sensing apparatus at least one working electrode of the plurality of working electrodes is configured to sense background noise. The biochip unit further includes a plurality of capillary holes configured to create a feedback system for enabling nonlocalized distribution of the predetermined amount of analyte over the upper biochip surface. The biochip unit further includes a Positive Temperature Coefficient (PTC) coil configured to stabilize and control a temperature of the biochip unit.

[074] The processor is further enabled to control a temperature of the PTC coil to enable performing of in-situ Polymerase Chain Reaction (PCR) or reverse-transcription PCR. The PCR reagents can be preloaded and dried onto the biochip surface as a master mix. The sensing apparatus can determine the analytes for a volume of the analyte varies between 01 pL to 200 pL.

[075] The plurality of working electrodes comprises a plurality of working electrodes connected to a plurality of respective input ports of a multiplexer circuit and the processor is connected to an output port of the multiplexer circuit. The sensing apparatus further includes a bio-sensing medium provided on a portion of at least one working electrode of the plurality of working electrodes.

[076] The plurality of test signals corresponds to Linear Sweep Voltametry (LSW), Cyclic Voltametry (CV), Square Wave Voltametry (SWV), Differential Pulse Voltametry (DPV), Normal Pulse Voltametry (NPV), Electrochemical Impedance Spectroscopy (EIS), Reverse Pulse Voltametry (RPV), Differential Square Wave Voltametry (d-SWV), Amperometry, Potentiometry, Chrono-amperometry, Anodic Stripping Voltametry, Dielectric Spectroscopy, and combinations thereof. The plurality of predetermined parameters includes current resulting from an applied potential, differential current peak value, ohmic resistance of an electrolyte solution, a constant phase element, Warburg impedance, charge transfer resistance, and non-linear combinations thereof.

[077] The sensing apparatus further includes a Programmable Gain Amplifier (PGA). The processor is further enabled to merge the plurality of observed values corresponding to one or more of the plurality of predetermined parameters obtained from a plurality of working electrodes. The processor is further enabled to merge the plurality of observed values corresponding to one or more of the plurality of predetermined parameters obtained from a working electrode of the plurality of working electrodes, the working electrode interrogated using multiple different interrogation methods. The processor is further enabled to perform Principal Component Analysis (PCA) on the plurality of predetermined parameters.

[078] For determining the plurality of deduced values, the processor is further enabled to implement a Machine Learning (ML) algorithm, the ML algorithm trained on a plurality of known analyte values of the plurality of respective analyte parameters, a plurality of observed values of the plurality of respective predetermined parameters, and a plurality of predicted analyte values of the plurality of respective analyte parameters. The ML algorithm is further trained on a plurality of environmental factors.

[079] The processor is further enabled to transmit the plurality of deduced values to a cloud-based database through the communication interface connected with a communication network. The processor is further enabled to receive one or more of protocol instructions, software updates, firmware updates, configuration data, ML models, and data-dependent instances from the cloud-based database through the communication interface connected with a communication network. The processor is further enabled to transmit the plurality of deduced values to a generative Artificial Intelligence (Al) server implementing a generative Al tool, through the communication interface connected with a communication network, and receive an Al generated interpretation of the plurality of deduced values.

[080] In another embodiment of the present invention, there is provided a method for determining a plurality of deduced values corresponding to a plurality of analyte parameters of an analyte, using a sensing apparatus. The method includes steps of generating, using a function generator, one or more test signals, and transmitting the one or more test signals to a plurality of working electrodes of the sensing apparatus, determining a plurality of observed values of a plurality of respective predetermined parameters, using the plurality of working electrodes, in response to the one or more test signals and presence of at least a part of a predetermined amount of the analyte in contact with the plurality of working electrodes, and determining a plurality of deduced values corresponding to a plurality of analyte parameters of the analyte from the plurality of observed values of the plurality of respective predetermined parameters.

[081] Several embodiments of the present invention will now be explained regarding FIGS 1A-8.

[082] FIG. 1A illustrates a sensing apparatus 100 for an electrochemical system, in accordance with an embodiment of the present invention. The sensing apparatus 100 includes a reservoir 102 at least partially filled with an electrolyte 110. The reservoir 102 is configured to receive a predetermined amount of an analyte to be mixed with the electrolyte. In the absence of the predetermined amount of analyte, when provided with a potential through a battery or a function generator, the sensing apparatus 100 will exhibit an initial set of values for characteristics such as charge current, faradaic current, potential difference between any two points in the electrochemical system, overall impedance, etc. However, such characteristics will attain a new set of values when the predetermined amount of the analyte is added to the electrolyte. The difference in the initial set of values and the new set of values would be indicative of the properties of the analyte. However, in several embodiments of the invention (for example in microfluidic applications), the reservoir 102 may not be provided with the electrolyte 110 initially, whereas the predetermined amount of the analyte in itself may act as the electrolyte 110. In several embodiments of the invention, the volume of the analyte varies between 01 pL to 200 pL.

[083] In several embodiments of the invention, the electrolyte 110 is envisaged to be a solution of a salt acting as a solute and a solvent. Biological fluids such as whole-blood, plasma, serum, urine, saliva can also act as an electrolyte under this definition. However, in several alternate embodiments, the electrolyte 110 may be a solid pure substance or a mixture of two more solid pure substances. In most of the circumstances, at least one of the components of the electrolyte 110 is a salt. In that regard, the salt may be selected from Ammonium salts (with organic solvents), tetrabutylammonium salts (with dichloromethane and acetonitrile-based solutions), tetrahexylammonium salts (for benzene), etc. The reservoir 102 may also be provided with inlet ports 112 in a cap 113 of the reservoir to allow degassing of the reservoir 102 or the addition of a reagent, such as an analyte into the reservoir 102.

[084] Further, the sensing apparatus 100 includes a plurality of working electrodes 104. However, for the sake of simplicity, only one working electrode 104 has been illustrated FIG. 1A. The plurality of working electrodes 104 is supposed to be functionalized to specifically receive and detect the analyte on a surface of the plurality of working electrodes 104. In a biochemical or a physiological scenario, the sensing apparatus 100 may include a plurality of working electrodes (See FIG. 1D and FIG. 5A) for testing a plurality of respective biomarkers. The plurality of working electrodes 104 is envisaged to be composed of a redox-inert material in the potential range of interest. In that regard, the plurality of working electrodes 104 may be composed of glassy carbon, platinum, graphene, carbon nanotubes, or gold. In several embodiment of the invention, at least one working electrode of the plurality of working electrodes 104 may be configured to sense background noise. The sensed background noise may then be subtracted from the measurements made by the rest of the working electrodes to provide more accurate observed values of predetermined parameters (Step 206 of FIG. 2). Further discussion on measurement and utilization of the measured background noise has been provided in references to FIGS 1B-1D.

[085] FIG. 1B illustrates a segment of a circuitry of the sensing apparatus 100, in accordance with an embodiment of the present invention. A counter electrode CE and a reference electrode RE are connected to output and negative terminals of an op-amp CA. Also, illustrated is a working electrode WE. This is in essence a voltage follower. In a voltage follower configuration, there is no gain, and the output terminal voltage will always match the negative and positive terminals of the op-amp CA. That means that the counter electrode CE will increase the volage until the voltage matches the potential in the positive (and negative) lead, and essentially overcome any resistance Rm in the media. At this point, the resistance Rm in the media is ignored, and only the electrochemical properties of the surface of the working electrode WE are measured.

[086] FIG. 1C illustrates an example representation of a circuit at a surface of the working electrode WE, in accordance with an embodiment of the present invention. A resistance Re of the electrolyte, a double layer capacitance Cdl and a charge transfer resistance Ret are present at the surface of the working electrode WE. (Surface resistance Rw of the working electrode WE is ignored for sake of simplicity). The problem is that even after target binding to the molecular probe, it is essentially impossible to determine the effect that the electrolyte itself had on the signal. Therefore, a background sensing electrode is implemented.

[087] FIG. 1D illustrates a comparison between a working electrode WE1 measuring the background noise and a working electrode WE2 analyzing a target analyte, in accordance with an embodiment of the present invention. The working electrode WE1 measuring the background noise will be non-functionalized or have an inert or a non-functional probe on its surface, and the working electrode WE2 analyzing the target analyte will have a target probe on its surface. The target probe and the target analyte will bind and change the surface resistance and capacitance of the working electrode WE2, while the target analyte will not bind to the inert probe or non-functionalized electrode and have a minimal effect on the surface electrochemistry of the working electrode WE1. Differences and similarities between Signal 1 and Signal 2 can be used to determine what constitutes the target signal and what is considered background noise.

[088] Referring to FIG. 1A, the sensing apparatus 100 includes a reference electrode 106. The reference electrode 106 is configured to be maintained at a reference equilibrium potential. The reference equilibrium potential is the potential against which the potential of the plurality of working electrodes 104 can be measured. Commonly used reference electrodes include Saturated Calomel Electrode (SCE), Standard Hydrogen Electrode (SHE), and AgCl / Ag electrode.

[089] FIG 1E. illustrates the reference electrode 106 of the sensing apparatus 100, in accordance with an embodiment of the present invention. It is to be noted here that although the reference electrode 106 has been illustrated as a liquid junction electrode, a person skilled in the art would appreciate that the liquid junction construction of the reference electrode 106 may be replaced with a solid-state construction, without departing from the scope of the invention. Any of the working electrodes depicted in 500 may be reconfigured to be used as a solid-state carbon graphene or silver / silver chloride reference electrode. The reference electrode 106 includes a silver wire 132 inserted in a glass tube 134 filled with the electrolyte 110. A heat shrink tubing 136 and a porous glass tip 138 have been provided at the end of the glass tube 134.

[090] Referring to FIG. 1A, the sensing apparatus 100 further includes a counter electrode 108. The purpose of the counter electrode 108 is to complete the circuit when a potential is applied to the plurality of working electrodes 104. The surface area of the counter electrode 108 is generally kept greater than the surface area of the plurality of working electrodes 104. The sensing apparatus 100 further includes a function generator 114 configured to generate a plurality of test signals of a plurality of respective predetermined characteristics. The plurality of test signals in that regard may be generated in the form of time-varying potential applied to the plurality of working electrodes 104 or in the form of time-varying current applied to the plurality of working electrodes 104. The test signal thus generated by the function generator 114 would depend upon the electroanalytical technique used for testing the analyte. The function generator 114 is envisaged to include an analog switch for switching between alternating current (AC) signal generation and direct current signal generator.

[091] The sensing apparatus 100 further includes a control module 116 including a processor 118, a memory unit 120 configured to store machine-readable instructions, a communication interface 122, and a storage device 124. In several embodiments of the invention, the storage device 124 and / or the memory unit 120 may be configured to receive new protocols, software updates, algorithms, etc. through the communication interface 122. The control module 116 will be discussed in detail in the following discussion. In several embodiments of the invention, the sensing apparatus 100 further includes a Programmable Gain Amplifier (PGA) 115 connected between the plurality of working electrodes 108 and the processor 118. A person skilled in the art would appreciate that the PGA 115 may also be connected between any one or more of the plurality of working electrodes 104 and the processor 118, without departing from the scope of the invention. The PGA 115 helps adjust the range of detection according to the analyte to be measured. For example, glucose levels are in the pM scale, while hormone levels are in the nano-M or pico-M scale. Therefore, signal amplification can be modified according to the concentration of the specific analyte.

[092] The communication interface 122 of the sensing apparatus 100 is connected to a communication network 123. Further connected to the communication network 123 is a cloud-based database server 126 associated with a cloud-based database 125. Also, connected to the communication network 123 is a generative Al server 128 through an Application Program Interface (API) server 127. The generative Al server 128 has a generative Al database 129 associated. The generative Al database 129 may include source code and other enabling data for implementation of a generative Al tool, such as, GPT-4, ChatGPT, Claude, Llama, Bard, AlphaCode, etc.

[093] FIG. 1F illustrates an adaptation 150 of the sensing apparatus 100 for the prevention of loss of solvent, in accordance with an embodiment of the present invention. In adaptation 150, an inert gas 154 maintained in the reservoir 102 is pre-saturated with vapors of the electrolyte 110 in a pre-bubbler 152, before the inert gas 154 is allowed to enter the reservoir 102 through a tubing 156.

[094] FIG. 1G illustrates a plurality of working electrodes 104i, 1042, 104s, 1044, 104s, ...104nconnected to the processor 118 through a multiplexer 160, in accordance with an embodiment of the present invention. In that regard, the multiplexer 160 may be provided with a plurality of select lines Si, S2, S3,.... Sm. It is to be noted that the sensing apparatus 100 has been illustrated in FIGS 1A - 1D on a magnified scale for clearly defining an example construction of the sensing apparatus 100. However, a person skilled in the art would appreciate that the modern manufacturing methods allow several components of the sensing apparatus 100 to be miniaturized, for achieving higher performance and efficiency, to scales ranging between 1 mm to 1 nm through techniques such as Very Large-Scale Integration (VLSI) or Ultra Large Scale Integration (ULSI). Therefore, several elements of the sensing apparatus 100 may be embodied as a biochip unit (See FIG. 5A and 5B), without departing from the scope of the present invention. Such elements included in the biochip unit may include the reservoir 102, the plurality of working electrodes 104, the reference electrode 106, the counter electrode 108, the electrolyte 110, the inlet ports 112, and the cap 113 and capillary holes 627. Moreover, the function generator 114, the PGA 115, and the control module 116 including the processor 118, the memory unit 120, the communication interface 122, and the storage device 124 may be provided within a housing of a receptacle device (See FIGS 4A and 4B).

[095] Furthermore, additional functionalities may also be integrated into the receptacle device. Such additional functionalities may include digital processing (for example, digital filters, FFT algorithms, and data arrays), trans-impedance amplification through a transimpedance amplifier for converting a current signal into a voltage signal so that the voltage signal can be measured by an ADC, and peak detection through a peak detector for converting an AC signal into a DC signal. The DC signal can further be filtered through a Low Pass Filter (LPF) to eliminate noise. The implementation of the transimpedance amplifier, the peak detector, and the LPF makes the sensing apparatus 100 to be more precise and economical and less prone to failures.

[096] FIG. 2 illustrates a method 200 for determining a plurality of deduced values corresponding to a plurality of analyte parameters of an analyte, using the sensing apparatus 100, in accordance with an embodiment of the present invention. A predetermined amount of the analyte (for example 40 pL) is introduced into the reservoir 102 in a manner such that the analyte either dissolves into the electrolyte 110 or acts as the electrolyte 110 by spreading across the sensing apparatus 100 (acting as the biochip) through capillary action. The steps of the method 200 are performed by the processor 118 executing the machine-readable instructions stored in the memory unit 120. Further, any data generated internally and / or received from a data resource such as an online repository or data library are stored in the storage device 124.

[097] The method 200 begins at Step 202 when the processor 118 generates a plurality of test signals using the function generator 114. In several embodiments of the invention, the function generator 114 may act as a potentiostat (signal maintaining a constant voltage) or a galvanostat (signal maintaining a constant current). The plurality of test signals is transmitted to the plurality of working electrodes 104. In that regard, the plurality of test signals may correspond to Linear Sweep Voltametry (LSW), Cyclic Voltametry (CV), Square Wave Voltametry (SWV), Differential Pulse Voltametry (DPV), Normal Pulse Voltametry (NPV), Electrochemical Impedance Spectroscopy (EIS), Reverse Pulse Voltametry (RPV), Differential Square Wave Voltametry (d-SWV), Amperometry, Potentiometry, Chrono-amperometry, Anodic Stripping Voltametry, Dielectric Spectroscopy, and combinations thereof. In several embodiments of the invention, for biochemical or physiological applications, the plurality of working electrodes 104 may be provided with a bio-sensing medium configured to be in contact with at least a part of the predetermined amount of analyte. In several embodiments of the invention, an inert and non-functional molecular probe may also be provided on a portion of one or several of the plurality of working electrodes 104 for measurement of the background noise. In that regard, the plurality of working electrodes 104 may be functionalized with the bio-sensing medium via cross-linking reactions such as the NHS ester or epoxide ring reactions or direct covalent bond of the probe to the surface of the working electrode (thiol-gold for example). The provision of the inert and non-functional molecular probe at least one working electrode of the plurality of working electrodes 104 provides background measurement which facilitates the analysis of the Randles circuit simulation as direct information on resistance and capacitive nature of the analyte can be extracted and removed from final calculations. In essence, the working electrode configured to sense the background noise removes shared elements between itself and another working electrode, thus allowing to subtract common elements (e.g. electrolyte resistance) and amplify differences (e.g. changes induced by target-probe interaction at other electrode) between the background sensing and any other working electrode.

[098] Subsequently or parallelly, at Step 204 the reference electrode is maintained at the reference equilibrium potential. At Step 206, the processor 118 determines a plurality of observed values of a plurality of respective predetermined parameters, using the plurality of working electrodes 104. The processor 118 determined the plurality of observed values in response to the one or more test signals and the presence of the at least the part of the predetermined amount of the analyte in contact with the plurality of working electrodes 104. In several embodiments of the invention, the plurality of predetermined parameters comprises current resulting from an applied potential, differential current peak value, ohmic resistance of the electrolyte solution 110, a constant phase element, Warburg impedance, charge transfer resistance, and non-linear combinations thereof. In several embodiments of the invention, the processor 118 performs Principal Component Analysis (PCA) on the plurality of predetermined parameters to reduce the total number of parameters by merging correlated parameters. The PCA is further enabled by the auto-generation of feature vectors. The feature vectors may include, for example, components in equivalent circuits, polynomials, neural networks and more nonlinear combinations of parameters. The learning process (See FIG. 3), whether through deep learning or the application of Singular Value Decomposition, permits the selection of the relevant features.

[099] In several embodiments of the invention, the processor 118 merges the plurality of observed values corresponding to one or more of the plurality of predetermined parameters obtained from the plurality of working electrodes 104i, 1042,1043,1044,104s, ...104n. Alternately, in several embodiments of the invention, the processor 118 merges the plurality of observed values corresponding to one or more of the plurality of predetermined parameters obtained from each one of the plurality of working electrodes 104 interrogated using multiple different signals and interrogation methods. For example, the multiple different signals may correspond to DC and AC signals at 0.1 Hz, 1kHz, 100kHz, 1MHz, etc. The step of merging observed values corresponding to multiple interrogation methods (also referred to as sensor fusion) offers several advantages, viz., • Improved accuracy: By combining data from multiple interrogation methods, sensor fusion can provide more accurate measurements of the system or environment being monitored than any single interrogation method could provide on its own. • Increased reliability: Sensor fusion can improve the reliability of the system by allowing it to function even if one interrogation method fails or provides inaccurate data. This redundancy can help prevent system failures and improve safety. • Greater coverage: By using multiple interrogation methods, sensor fusion can provide a more complete view of the environment or system being monitored, allowing for greater coverage and more comprehensive analysis. • Reduced noise: Different interrogation methods may have different types of noise, but by fusing the data from multiple interrogation methods, the noise can be reduced, resulting in a more accurate reading. • Improved decision-making: Sensor fusion can provide more detailed and accurate information, leading to better decision-making.

[0100] In Step 208, the processor 118 determines a plurality of deduced values corresponding to a plurality of analyte parameters of the analyte from the plurality of observed values of the plurality of predetermined parameters. The plurality of analyte parameters, for example, may include blood glucose level, viral antigen load, concentration of antibodies, concentration of cancer biomarkers, etc. In that regard, the analyte may be human blood, saliva, urine, stool, or sweat. In several embodiments of the invention, for determining the plurality of deduced values, the processor 118 employs Machine Learning (ML) algorithms that have been previously trained on known data.

[0101] In several embodiments of the invention, the processor 118 transmits the plurality of deduced values to the cloud-based database 125 through the communication interface 122 connected with the communication network 123. The measurements made by the sensing apparatus 100 may be stored remotely in the cloud-based database 125 for future references. The cloud database 125 and / or the database server 126 may also be used to facilitate transfer new protocol instructions, configuration data, software updates, ML models and other data-dependent instances to the sensing apparatus 100. In several embodiments, the cloud-based database 125 may be connected to several sensing apparatuses 100 associated with several different users. Data obtained from the several different sensing apparatuses 100 may anonymized and stored in data tables and data structures for anthropological research, regional health policy development, drug development, and development of newer software / firmware / hardware associated with the sensing apparatus 100.

[0102] In several embodiments of the invention, the processor 118 is further enabled to transmit the plurality of deduced values to the generative Al server 128 implementing a generative Al tool, through the API server 127. In response the processor 118 receives an Al generated interpretation of the plurality of deduced values. In that regard, the processor 118 may obtain an API key for the generative Al, implement an HTTP client, constructing an API request, and parse a received JSON response. The interpretation of the plurality of deduced values may then be presented to the user without needing a trained clinician or a healthcare service provider to perform the same job.

[0103] FIG. 3 illustrates a method 300 for training an ML algorithm for the determination of the plurality of deduced values corresponding to the plurality of respective analyte parameters of the analyte. The method 300 begins at Step 302 when the processor 118 assigns a plurality of weights to the plurality of respective predetermined parameters. At Step 304, the processor 118 receives a plurality of known analyte values of the plurality of respective analyte parameters and stores the plurality of known analyte values in the storage device 124. At Step 306, the processor 118 deploys an electroanalytical technique such as CV, SWV, EIS to the analyte received in the reservoir 102. At Step 308, the processor 118 determines the plurality of observed values of the plurality of respective predetermined parameters. In Step 310, the processor 118 determines a plurality of predicted analyte values of the plurality of respective analyte parameters from the plurality of observed values. In Step 312, the processor 118 modifies the plurality of weights based on differences between the plurality of known analyte values and the plurality of predicted analyte values until convergence is achieved. In several embodiments of the invention, for modification of the plurality of weights, the processor can also accounts for environmental factors such as temperature, humidity, vibration, etc. EXAMPLE 1

[0104] FIG 4A illustrates a perspective view of an example receptacle device 400 of the sensing apparatus 100, in accordance with an embodiment of the present invention. FIG. 4B illustrates an exploded view of the example receptacle device 400 of FIG. 4A. The receptacle device 400 includes a data and power transfer port 402. The data and power transfer port 402 may be a USB A / B / C type port, an Ethernet port, an HDMI port, etc. Furthermore, the receptacle device 400 includes a memory card reader slot 404. The memory card reader slot 404 may be configured for reading several different kinds of memory cards. In that regard, machine-readable instructions or other forms of data such as ambient conditions, training data for Al and ML algorithms, material properties, etc. may be fed into the receptacle device 400 through the memory card reader slot 404 or the data and power transfer port 402 or via over-the-air update through a wireless connection (WiFi or Bluetooth). Also, a battery 414 of the receptacle device 400 may be charged through the data and power transfer port 402.

[0105] The receptacle device 400 includes a receptacle unit 406 configured to receive a biochip unit (See FIGS 5A and 5B) thereupon. Furthermore, the receptacle device 400 includes a user interface unit 408. In several embodiments of the invention, the user interface unit 408 may be an LED or LCD-based capacitive or resistive touch screen. The user interface unit 408, the receptacle unit 406 and the battery 414 may be electrically coupled to a single motherboard 412. Moreover, the motherboard 412, the battery 414, the receptacle unit 406, and the user interface unit 408 may be contained in a single housing 409. The housing 409 may further be split into an upper housing portion 410 and a lower housing portion 418 that may be connected through snap fitment or threaded fasteners to provide the housing 409. Although not illustrated in FIGS 4A and 4B, the receptacle device 400 is further envisaged to include the function generator 114, the control module 116 including the processor 118, the memory unit 120, the communication interface 122, and the storage device 124. In several embodiments of the invention, the receptacle device 400 is further envisaged to include the PGA 115.

[0106] FIG. 5A illustrates a top view of an example biochip unit 500 of the sensing apparatus 100, in accordance with an embodiment of the present invention. FIG. 5B illustrates a bottom view of the example biochip unit 500 of FIG. 5A. The biochip unit 500 includes an upper biochip surface 503 in an upper biochip portion 501. The biochip unit 500 includes a counter electrode 502, provided at the center of a circular array of a plurality (12) of working electrodes 504 or present in an interdigitated fashion. The counter electrode 502 and the plurality of working electrodes have been provided in the top portion of the biochip unit 500. In a lower biochip portion 505 of the biochip unit 500, there is provided a Positive Temperature Coefficient (PTC) coil 506 configured to stabilize and / or control the temperature of the biochip unit 500. Furthermore, the temperature of the PTC coil 506 can be precisely controlled to fulfill applications such as in-situ Polymerase Chain Reaction (PCR) and reverse-transcription PCR. Thus, allowing for the possibility of amplifying a number of nucleic acid molecules present in a sample of analyte for subsequent measurement via the plurality of working electrodes 504 already incorporated in the biochip unit 500.

[0107] FIG. 6A illustrates a perspective view of the example receptacle unit 406 of the receptacle device 400, in accordance with an embodiment of the present invention. The receptacle unit 406 includes a plurality of electrically conducting pins 602 that are protruding upwards and are configured to make an electrical connection and a mechanical coupling with the biochip unit 500. FIG. 6B illustrates a top perspective view of the biochip unit 500, in accordance with an embodiment of the present invention. The biochip unit 500 further includes a plurality of electrically conducting holes 604 configured to receive the plurality of respective electrically conducting pins 602 therewithin to form the electrical connection and the mechanical coupling with the receptacle unit 406. The biochip unit 500 further includes a cover layer 605 made up of an acrylic material. The cover layer 605 is provided on top of the plurality of working electrodes. The cover layer 605 includes a hole in the central region of the cover layer 605.

[0108] Further, a central ring 606, for example, made of metal or plastic, with a central hole therebetween, has been provided in the central region below the cover layer 605. The hole in the central ring 606 overlaps with the hole in the cover layer 605. A reservoir 607 is defined in the upper biochip portion 501 between the upper biochip surface 503 and the cover layer 605. The central ring 606 creates a gap between the cover layer 605 and the plurality of working electrodes enabling the distribution of the analyte over the entire biochip unit 500 through capillary action. FIG. 6C illustrates a perspective view of an assembly 625 of the receptacle unit 406 of FIG. 6A and biochip unit 500 of FIG. 6B. The cover layer 605 further includes several capillary holes 627 throughout the biochip unit 500. The several capillary holes 627 serve to create a feedback pressure system. Once the analyte reaches one of the several capillary holes 627, the pressure increases locally in that region, and the analyte fills other regions of the biochip unit 500.

[0109] FIG. 7A illustrates a configuration of the biochip unit in accordance with an exemplary embodiment of the present invention. The biochip unit 700 shown in FIG. 7A includes a counter electrode 702 in a crescent-moon configuration arranged around an array of a plurality of working electrodes 704. Any of the working electrodes circuit connection to the biochip receptacle can be modified to become a reference electrode. The edges of the biochip unit are provided with electrical holes for connecting with electrical pins in the receptacle unit.

[0110] FIG. 7B illustrates another configuration of the biochip unit in accordance with an exemplary embodiment of the present invention. FIG. 7B includes a counter electrode 702 arranged in an interdigitated manner around an array of a plurality of working electrodes 704. Any of the working electrodes circuit connection to the biochip receptacle can be modified to become a reference electrode.

[0111] FIG. 7C illustrates another configuration of the biochip unit in accordance with an exemplary embodiment of the present invention. The biochip unit 700 is in form a strip that can be inserted in the receptacle unit. The strip has plurality of working electrodes 702 arranged in vertical linear manner along the length of strip. The reference electrode and the counter electrode are present at the top of the strip. The above layer of the strip is inserted into the receptacle unit and is provided with a plurality of electrical hone for connecting with electrical pins in the receptacle unit.

[0112] FIG. 7D illustrates another configuration of the biochip unit in accordance with an exemplary embodiment of the present invention. In this arrangement, the plurality of working electrodes 704 are arranged in matrix of rows and columns. The connection with the receptacle unit is through a card slot communication interface provided at the top of the biochip unit.

[0113] FIG. 8 shows a sensing apparatus with biochip unit in accordance with an embodiment of the present invention. The sensing apparatus comprises the biochip unit 802 integrated in the receptacle unit 804. The sensing apparatus is rectangular in shape with receptacle unit 804 is provided in rectangular shape. The biochip unit 802 is provided at the top of the receptacle unit 804. ADVANTAGES

[0114] The embodiments of the present invention as discussed above offer several advantages such as, but not limited to, each analyte being interrogated with a signal that maximizes the detection capability, independently from the media (blood, serum, buffer, etc.). Also, implementation of PCA allows for the construction of complex features that capture the coupling with other factors that might influence analyte measurement (e.g., temperature, type of media, influence of other analytes, etc.).

[0115] Moreover cloud connectivity enables effective and widespread access to critical clinical data, swift analysis of biomarker levels for immediate clinical action, collaborative sharing of data across multiple research institutions, employment of advanced machine learning for comprehensive data interpretation, strong safeguards for patient data confidentiality and compliance with health regulations, infrastructure capable of expanding to meet increasing data demands, economical and efficient handling of extensive clinical datasets.

[0116] The implementation of generative Al enables enhanced data analysis, adaptive learning, automation and efficiency, personalized diagnostics, cost-effectiveness and accessibility, improved accuracy, continuous learning, reduced human error, tailored diagnostic insights, faster processing times, early disease detection, subtle pattern identification, anomaly detection in data, quantifying low-concentration biomarkers, reduced workload, reproducible results, precision medicine facilitation, resource-limited settings applicability, integrating new biomarker data, scalable diagnostic solutions, advanced signal processing, minimized manual labor, data-driven clinical insights, healthcare innovation, robust diagnostic algorithms. The integration of the biochip, sensing apparatus for automatic sample processing, and result interpretation via Al or large language models integration would allow real time sample analysis and diagnostics

[0117] Various modifications to these embodiments are apparent to those skilled in the art, from the description and the accompanying drawings. The principles associated with the various embodiments described herein may be applied to other embodiments. Therefore, the description is not intended to be limited to the embodiments shown along with the accompanying drawings but is to provide the broadest scope consistent with the principles and the novel and inventive features disclosed or suggested herein. Accordingly, the invention is anticipated to hold on to all other such alternatives, modifications, and variations that fall within the scope of the present invention.

Claims

1. A sensing apparatus for monitoring one or more analytes in a sample, comprising: a biochip unit having a reservoir to pour a sample containing the one or more analyte; a plurality of working electrode configured to be in contact with the one or more analyte;a receptacle device configured to be electrically and mechanically connected to the biochip unit;a function generator configured to generate a plurality of test signals of a plurality of predetermined parameters;wherein the function generator transmits one or more test signals to the plurality of working electrodes and determine a plurality of observed values of the plurality of predetermined parameters using the plurality of working electrodes in response to the one or more test signals; andwherein the sensing apparatus determine an amount of the one or more analyte in contact with the plurality of working electrode.

2. The sensing apparatus of claim 1, wherein the sensing apparatus further comprising a control electrode, a reference electrode and a counter electrode.

3. The sensing apparatus of claim 1, wherein one of the plurality of working electrode is configured to sense background noise.

4. The sensing apparatus of claim 1, wherein the plurality of working electrode is connected to a plurality of multiplexer circuit.

5. The sensing apparatus of claim 1, wherein the one or more test signal comprises Linear Sweep Voltametry (LSW), Cyclic Voltametry (CV), Square Wave Voltametry (SWV), Differential Pulse Voltametry (DPV), Normal Pulse Voltametry (NPV), Electrochemical Impedance Spectroscopy (EIS), Reverse Pulse Voltametry (RPV), Differential Square Wave Voltametry (d-SWV), Amperometry, Potentiometry, Chrono-amperometry, Anodic Stripping Voltametry, Dielectric Spectroscopy.

6. The sensing apparatus of claim 1, wherein the plurality of predetermined parameters includes current resulting from an applied potential, differential current peak value, ohmic resistance of an electrolyte solution, a constant phase element, Warburg impedance, charge transfer resistance, and non-linear combinations.

7. The sensing apparatus of claim 1 further comprising a control circuity comprising a processor, a memory unit and a storage device, the control circuitry is configured to generate an analytic result.

8. The sensing apparatus of claim 1 further comprising an automated programmable gain amplifier for automated sensitivity adjustment for required range of detection.

9. The sensing apparatus of claim 1, wherein the sensing apparats is configured to connect wirelessly with an external device.

10. The sensing apparatus of claim 1, wherein the sensing apparatus is provided with a machine learning capability that includes but is not limited to in-situ principal analytes analysis for enhancing signal interpretation for detecting the amount of the analyte and detection of anomaly.

11. A method monitoring one or more analytes in a sample, comprising: providing a biochip unit having a reservoir to pour a sample containing the one or more analyte, the biochip unit having a plurality of working electrode configured to be in contact with the one or more analyte;providing a receptacle device configured to be electrically and mechanically connected to the biochip unit;generating a plurality of test signals of a plurality of predetermined parameters by a function generator;wherein the function generator transmits one or more test signals to the plurality of working electrodes and determine a plurality of observed values of the plurality of predetermined parameters using the plurality of working electrodes in response to the one or more test signals; andwherein the sensing apparatus determine an amount of the one or more analyte in contact with the plurality of working electrode.12.The method of claim 11, wherein the biochip comprises a plurality of working electrode, a reference electrode and a counter electrode.13.The method of claim 12, wherein one of the plurality of working electrode is configured to sense background noise.14.The method of claim 12, wherein the plurality of working electrode is connected to a plurality of multiplexer circuit.15.The method of claim 11, wherein the one or more test signal comprises Linear Sweep Voltametry (LSW), Cyclic Voltametry (CV), Square Wave Voltametry (SWV), Differential Pulse Voltametry (DPV), Normal Pulse Voltametry (NPV),Electrochemical Impedance Spectroscopy (EIS), Reverse Pulse Voltametry (RPV), Differential Square Wave Voltametry (d-SWV), Amperometry, Potentiometry, Chrono-amperometry, Anodic Stripping Voltametry, Dielectric Spectroscopy.16.The method of claim 11, wherein the plurality of predetermined parameters includes current resulting from an applied potential, differential current peak value, ohmic resistance of an electrolyte solution, a constant phase element, Warburg impedance, charge transfer resistance, and non-linear combinations.17.The method of claim 11 wherein the receptacle unit is provided with a control circuity comprising a processor, a memory unit and a storage device, the control circuitry is configured to generate an analytic result.

18. The method of claim 11 wherein the method further comprising using an automated programmable gain amplifier for automated sensitivity adjustment for required range of detection.19.The method of claim 11, wherein the method comprises connecting the biochip unit wirelessly with an external device.20.The method of claim 11, wherein the method uses a machine learning capability that includes but is not limited to in-situ principal analytes analysis for enhancing signal interpretation for detecting the amount of the analyte and detection of anomaly.

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