KR20230137040A - COVID diagnostic kit for detecting COVID antigen - Google Patents

Abstract

The present invention relates to a diagnostic kit for COVID diagnosis, and more specifically, to a diagnostic kit for COVID diagnosis that comprises: a connection module electrically connectable to an external device; and a sensing module detachably attached to the connection module and having a microwell or nanowell structure formed therein, wherein diagnostic kit for COVID diagnosis can electrochemically quantifies COVID antigens and enables in vitro diagnosis with the components thereof. The diagnostic kit has the advantage of being able to quantify a very small amount of COVID antigens and perform in vitro diagnosis, being able to perform various types of tests by replacing the sensing module, and being able to perform continuous and rapid tests by replacing only the sensing module while the connection module is connected to an external device.

Description

COVID diagnostic kit for detecting COVID antigen}

The present invention relates to a COVID diagnostic kit, and more specifically, in vitro diagnosis by electrochemically quantifying COVID antigens through a diagnostic kit composed of a connection module that can be electrically connected to an external device and a sensing module that is detachable from the connection module. It is about a COVID diagnostic kit that makes it possible.

Recently, research on biosensors for diagnosing specific molecules has been actively conducted, but technology development on biosensors for diagnosing specific molecules in the blood is insufficient.

Certain molecules in the blood have a large interference phenomenon with other molecules in the blood, have many non-specific bonds, and exist at extremely low concentrations, making it difficult to develop biosensors that diagnose specific molecules in the blood.

Meanwhile, COVID infections have recently increased rapidly, but it is difficult to measure the target substance for measuring COVID disease because it exists in very small amounts in the blood.

For COVID, antigen tests are mostly performed after symptom onset. Since the infection progresses rapidly after symptom onset, it is essential to quickly determine whether the patient is infected through rapid and accurate antigen measurement.

Therefore, since COVID disease patients are a high-risk group capable of rapid infection and transmission, quick and simple measurement is necessary, and the development of a COVID antigen diagnostic kit that can measure quickly and simply is necessary.

One aspect includes a connection module that can be electrically connected to an external device; And a diagnostic kit comprising a sensing module configured to detect a COVID antigen from an analysis sample introduced therein and transmit an electrical signal generated in response to the detected COVID antigen to the connection module, wherein the sensing module includes: , a sensor is provided that detects the COVID antigen from the analysis sample and reacts with the COVID antigen to generate the electrical signal, the sensor comprising: a substrate; and a plurality of electrodes provided on one side of the substrate and reacting with the COVID antigen to generate an electrochemical signal, wherein the sensing module is attachable and detachable from the connection module. will be.

Another aspect includes applying an analysis sample to the electrode of the diagnostic kit of claim 1; Applying a probe capable of binding to a COVID antigen to the electrode to which the analysis sample is applied; Applying an electron transport activating material to the electrode to which the probe is applied; and measuring the current.

One aspect includes a connection module that can be electrically connected to an external device; And a diagnostic kit comprising a sensing module configured to detect a COVID antigen from an analysis sample introduced therein and transmit an electrical signal generated in response to the detected COVID antigen to the connection module, wherein the sensing module includes: , a sensor is provided that detects the COVID antigen from the analysis sample and reacts with the COVID antigen to generate the electrical signal, the sensor comprising: a substrate; and a plurality of electrodes provided on one side of the substrate and reacting with the COVID antigen to generate an electrochemical signal, wherein the sensing module is attachable and detachable from the connection module. .

In one embodiment, the sensor may include a microwell or nanowell structure consisting of a plurality of grooves on the upper part of the electrode.

In one embodiment, the analysis sample of the diagnostic kit for diagnosing COVID may be a biological sample isolated from an individual.

In one embodiment, the sensor of the diagnostic kit for diagnosing COVID may not be coated with a material that can detect the COVID antigen by reacting with the COVID antigen.

In one embodiment, the electrochemical signal of the diagnostic kit for diagnosing COVID may be generated by further adding a probe capable of binding to the COVID antigen and an electron transfer activating material.

In one embodiment, the probe capable of binding to the COVID antigen in the diagnostic kit for diagnosing COVID may be a COVID antibody.

In one embodiment, the electrode of the diagnostic kit for diagnosing COVID may be a working electrode, a counter electrode, or a reference electrode.

In one embodiment, the microwell or nanowell of the diagnostic kit for diagnosing COVID may have a diameter of 50 nm to 50 ㎛.

In one embodiment, the connection module and the sensing module of the diagnostic kit for diagnosing COVID are detachably coupled to each other through magnetism, and may be electrically connected to each other through surface contact.

In one embodiment, the diagnostic kit for diagnosing COVID has one or more sensing modules, and one or more sensing modules may be attachable to or detachable from one connection module.

Another aspect includes applying an analysis sample to the electrode of the diagnostic kit of claim 1; Applying a probe capable of binding to a COVID antigen to the electrode to which the analysis sample is applied; Applying an electron transport activating material to the electrode to which the probe is applied; and measuring the current.

In one embodiment, the analysis sample in the method for providing information for COVID diagnosis may be a biological sample isolated from an individual.

The present invention relates to a COVID diagnostic kit, which performs an electrochemical analysis method and has the advantage of enabling in vitro diagnosis by quantifying a very small amount of COVID antigen in the blood.

In addition, the present invention has the advantage of improving resolution by inserting an analysis sample through a microwell or nanowell structure, and the present invention includes a connection module that is electrically connected to an external device, and a sensing module that is detachable from the connection module. Since it is composed of, various types of inspections can be performed by replacing the sensing module, and only the sensing module can be replaced while the connection module is coupled to an external device, which has the advantage of being able to perform continuous and rapid inspection.

In addition, the present invention has the advantage of being able to detect a very small amount of COVID antigen even if the sensor is not coated with a material that can detect COVID antigen by reacting with COVID antigen, and can be manufactured easily and economically.

Figure 1 is a usage diagram showing a state in which a kit according to an embodiment of the present invention is connected to an external device:
Figure 1a is a usage diagram showing a state in which the kit is connected to an external device in the form of a smartphone or tablet; and Figure 2b is a usage diagram showing a state in which the kit is connected to an external device in the form of a PC.
Figure 2 is a perspective view showing a kit in which a microwell or nanowell structure is formed according to an embodiment of the present invention.
Figure 3 is a plan view showing the kit according to an embodiment of the present invention in a disassembled state.
Figure 4 is a cross-sectional view taken along line VI-VI of Figure 3.
Figure 5 is a side view showing part “A” of Figure 3.
Figure 6 is a plan view schematically showing the disassembled state of the kit according to another embodiment of the present invention.
Figure 7 is an enlarged view of part “B” of Figure 6.
Figure 8 is a plan view schematically showing the disassembled state of the kit according to another embodiment of the present invention.
Figure 9 is a diagram schematically showing the process of combining part “C” of Figure 8.
Figure 10 is a side view schematically showing the disassembled state of the kit according to another embodiment of the present invention.
Figure 11 is a diagram showing two different electrochemical analysis methods:
Figure 11a is a diagram showing a label-free electrochemical analysis method; and FIG. 11B is a diagram showing an electrochemical analysis method using a probe and an electron transport activating material according to an embodiment of the present invention.
Figure 12 is a graph showing the results of measuring COVID antigens according to an experimental example.
Figure 13 is a graph showing the results of measuring COVID antigens according to an experimental example.
Figure 14 is a graph showing the results of measuring COVID antigens according to an experimental example.
Figure 15 is a graph showing the results of measuring COVID antigens according to an experimental example.

This specification clarifies the scope of rights of the present invention, explains the principles of the present invention, and discloses embodiments so that those skilled in the art can practice the present invention. The disclosed embodiments may be implemented in various forms.

Expressions such as “includes” or “may include” that may be used in various embodiments of the present invention refer to the existence of the corresponding function, operation, or component that has been disclosed, and one or more additional functions, operations, or components. There are no restrictions on components, etc. In addition, in various embodiments of the present invention, terms such as "comprise" or "have" are intended to indicate the presence of features, numbers, steps, operations, components, parts, or combinations thereof described in the specification. It should be understood that this does not exclude in advance the presence or addition of one or more other features, numbers, steps, operations, components, parts, or combinations thereof.

Terms containing ordinal numbers, such as first, second, etc., may be used to describe various components, but these components are not limited by the above-mentioned terms. The above-mentioned terms are used only for the purpose of distinguishing one component from another.

When a component is referred to as being "connected or coupled" to another component, the component may be directly connected or coupled to the other component, but there is no connection between the component and the other component. It should be understood that other new components may exist. On the other hand, when a component is said to be "directly connected" or "directly coupled" to another component, it will be understood that no new components exist between the component and the other component. You should be able to.

Meanwhile, a “module” or “unit” for a component used in this specification performs at least one function or operation. And, the “module” or “unit” may perform a function or operation by hardware, software, or a combination of hardware and software. Additionally, a plurality of “modules” or a plurality of “units” excluding a “module” or “unit” that must be performed on specific hardware or performed on at least one processor may be integrated into at least one module. Singular expressions include plural expressions unless the context clearly dictates otherwise.

In addition, when describing the present invention, if it is determined that a detailed description of a related known function or configuration may unnecessarily obscure the gist of the present invention, the detailed description thereof is abbreviated or omitted.

The present invention relates to a COVID diagnostic kit, and to a kit in which the sensing part can be replaced by using a connection module that can be electrically connected to an external device and a sensing module that is detachable from the connection module. Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the attached drawings.

Referring to FIG. 1, the kit 10 using a microwell or nanowell structure according to an embodiment of the present invention improves resolution by using the microwell or nanowell structure 220, and the kit 10 generates It is configured to be electrically connected to an external device 20 installed with software capable of measuring and analyzing the electrical signals.

Specifically, the kit 10 may be electrically connected to an external device 20 in the form of a smartphone or tablet, as shown in FIG. 1A, or may be electrically connected to an external device 20 in the form of a PC, as shown in FIG. 1B. However, the external device 20 is not limited to this, and may be used in various forms that can be electrically connected to the kit 10.

The external device 20 has a terminal portion (not shown) that can be coupled to the first connection terminal 110 provided in the connection module 100 so as to be electrically connected to the connection module 100 of the kit 10, which will be described later. It can be provided. In addition, the external device 20 includes a program or application that can perform qualitative and quantitative analysis of COVID antigens by measuring and analyzing the potential according to the redox reaction of the kit 10 when connected to the kit 10. This can be installed. Through this, the external device 20 can collect and analyze signals generated from the kit 10, and through this, various diseases or conditions can be detected, or changes in these can be measured and displayed.

Additionally, the external device 20 can be connected to the Internet through wired or wireless communication and transmit data measured through the kit 10 to a user terminal or a server of a medical institution. Through the transmitted data, test subjects or medical institutions can monitor their health status in real time.

For example, as an example, the external device 20 stores, analyzes, and stores signals (data) transmitted through an input unit (not shown), which is coupled to the kit 10 and is electrically connected to the kit 10. A control unit (not shown) that diagnoses, a display unit (not shown) that outputs the data received from the control unit in an externally identifiable form, a communication unit (not shown) that transmits the data received from the control unit to the selected user terminal and medical institution server, and It may include a power supply unit (not shown) that supplies power to the input unit, control unit, display unit, and communication unit.

A kit according to an embodiment of the present invention includes a connection module 100, a sensing module 200, and a sensor 210. Below, preferred embodiments of the present invention will be described in detail.

Referring to Figures 2 and 3, the connection module 100 can be electrically connected to the external device 20. For this purpose, the connection module 100 includes a first connection terminal 110, a second connection terminal 120, a controller 130, and a main body 140.

The first connection terminal 110 is coupled to the external device 20 and can be electrically connected to the external device 20. The first connection terminal 110 can be of various configurations as long as it can be electrically connected to the external device 20.

The first connection terminal 110 is coupled to the terminal provided on the external device 20 and has a shape corresponding to the terminal of the external device 20 to enable electrical connection with the external device 20. It can be done. Specifically, the first connection terminal 110 may be provided in the form of USB, micro USB, or PIN, but is not limited thereto, and can be configured in various configurations if it can be electrically connected to the external device 20. can be used

The second connection terminal 120 is coupled to the sensing module 200, which will be described later, and can be electrically connected to the sensing module 200. The second connection terminal 120 may be provided in the form of a micro USB or PIN, but is not limited thereto, and various configurations may be used as long as it can be electrically connected to the sensing module 200.

The controller 130 is electrically connected to the first connection terminal 110 and the second connection terminal 120, and generates a signal ( may be configured to control transmission of data). The controller 130 may be electrically connected to the first connection terminal 110 and the second connection terminal 120 through a wire, but is not limited to this. As long as the second connection terminal 120 can be electrically connected, various configurations can be used.

The main body 140 has a lower body on which the first connection terminal 110, the second connection terminal 120, and the controller 130 are installed, and is coupled to the lower body to connect the first connection terminal 110. , It may include an upper body that protects the second connection terminal 120 and the upper part of the controller 130.

Referring to Figures 2 and 3, the sensing module 200 detects COVID antigens from the analysis sample introduced therein, and transmits an electrical signal generated in response to the detected COVID antigens to the connection module 100. It is configured to transmit and is provided with a microwell or nanowell structure 220.

The analysis sample may refer to a biological sample isolated from an individual, including blood, plasma, serum, urine, mucus, saliva, tears, sputum, spinal fluid, pleural fluid, nipple aspirate, lymphatic fluid, airway fluid, serous fluid, and urogenital fluid. , breast milk, lymphatic fluid, semen, cerebrospinal fluid, fluid within an organ system, ascites, cystic tumor fluid, amniotic fluid, or a combination thereof. However, the analysis sample is not limited to this, and may be a variety of biological samples. Additionally, the biological sample may contain intact proteins. An intact protein may be a protein isolated from a biological sample without any modification of the protein. An intact protein may be a protein that has been isolated from a biological sample without protein digestion, for example by proteolytic enzymes.

The sensing module 200 may be provided with a sensor 210 that detects the COVID antigen from the analysis sample and reacts with the COVID antigen to generate the electrical signal. The sensor 210 may be provided with a substrate. It includes (211) a plurality of electrodes (212) and a microwell or nanowell structure (220).

The sensor 210 may not be coated with a sensing material (eg, antibody, etc.) that detects the COVID antigen by reacting with the COVID antigen contained in the analysis sample. Therefore, it is not necessary to detect COVID antigens using both a sensing agent that detects the COVID antigen (e.g., primary antibody) and a probe that can bind to the COVID antigen (e.g., secondary antibody), making kit preparation, and detection procedures. This has the effect of saving time and money in the process. Even if a sensing material such as an antibody is not coated on the sensor, there is an effect of detecting a very small amount of COVID antigen using the sensor.

When the sensor 210 comes into contact with an analysis sample, it interacts with the COVID antigen contained in the analysis sample to generate an electrical signal.

Accordingly, the external device 20 connected to the kit 10 can detect the presence or concentration of COVID antigens by analyzing the electrical signal generated by the kit 10. However, the sensor 210 is not limited to this, and may be configured to move, stop, filter, purify, react, and mix the analysis sample.

The electrochemical signal may be generated by adding a probe capable of binding to the COVID antigen and an electron transfer activating material.

The COVID antigen may be the receptorbinding domains (RBD) or the N-terminal domain (NTD) of the COVID virus surface protein (S protein). The probe capable of binding to the COVID antigen may be an antibody, IgM or IgG.

As used herein, the term “COVID” may refer to the COVID-19 virus (COVID 19, Severe Acute Respiratory Syndrome Coronavirus-2 or SARS-CoV-2).

The diagnostic kit according to an embodiment of the present invention uses an electrochemical analysis method to measure the amount of change in current and impedance according to multiple antigen-antibody reactions or complementary binding of DNA and RNA based on protein aggregation reaction. Various electrochemical analysis methods can be used to identify COVID antigens.

The diagnostic kit according to an embodiment of the present invention can determine COVID antigens in an analysis sample using various electrochemical methods such as cyclic voltammetry and square wave voltammetry (SWQ).

However, the electrochemical analysis method used in the diagnostic kit according to an embodiment of the present invention can be used as follows for quick and simple diagnosis.

The electrochemical analysis method according to an embodiment of the present invention includes a probe that binds to the COVID antigen, and an electron transfer activating material that causes oxidation and reduction reactions while binding to the probe to generate current in the microwell or nanowell. This can be done by inserting.

Next, the COVID antigen can be determined by applying a designated voltage to the electrode 212 and reading the current value.

The electron transfer activating material may be a material that generates current through oxidation or reduction reactions with the probe. Specifically, the electron transfer activating material may be ferrocene, methylene blue, or ferrate. However, the electron transfer activating material is not limited to this, and may be a variety of materials as long as they generate current through oxidation or reduction reactions with the probe.

Referring to FIG. 11, the conventional electrochemical analysis method is a label-free method in which a material capable of detecting a target material is fixed to an electrode, the target material is inserted, and the impedance is measured while applying an alternating voltage.

This method has a simple sample processing method, but as the impedance must be analyzed, it requires a long analysis time due to a complex analysis method, and requires expensive equipment because alternating voltage must be applied.

However, the electrochemical analysis method according to an embodiment of the present invention determines the target material by applying only a specified voltage to the electrode 212 and then reading the current value while using the probe and the electron transfer activating material, It has the advantage of having a short analysis time and being able to be manufactured with low-cost, portable equipment.

Additionally, particles treated with a fluorescent material may be inserted into the microwell or nanowell of the diagnostic kit according to an embodiment of the present invention. Accordingly, the diagnostic kit according to an embodiment of the present invention can simultaneously implement an electrochemical analysis method and an optical analysis method on one electrode.

One particle may react in one microwell or nanowell. That is, the microwell or nanowell and the particle may react 1:1.

When particles treated with a fluorescent material are inserted into an electrode that does not have a conventional microwell or nanowell structure, there is a problem that sensitivity is reduced due to protein aggregation. However, the diagnostic kit according to an embodiment of the present invention has the advantage of improving sensitivity while reducing protein aggregation by forming the microwell or nanowell structure and inserting the particle treated with a fluorescent material.

In particular, the diagnostic kit according to an embodiment of the present invention can improve sensitivity while reducing protein aggregation reaction as one particle is inserted into one microwell or nanowell and reacts 1:1.

In order for one particle to react 1:1 when inserted into one microwell or nanowell, the size of the particle is larger than 1/2 the diameter of the microwell or nanowell, and the size of the particle is larger than 1/2 of the diameter of the microwell or nanowell. It is preferable to be smaller than the diameter.

If the size of the particle is smaller than 1/2 of the size of the microwell or nanowell, a 1:1 reaction may not occur when two or more particles are inserted into one microwell or nanowell. The size of the particles is preferably larger than 1/2 of the size of the microwell or nanowell.

Additionally, if the size of the particle is larger than the microwell or nanowell size, the particle cannot be inserted into the microwell or nanowell, so it is preferable that the particle size is smaller than the microwell or nanowell size. . In this way, by adjusting the size of the particle, it is possible to cause a 1:1 reaction between the microwell or nanowell and the particle.

The substrate 211 provided in the sensor 210 may have a predetermined size, and the substrate 211 may have a size of 2 x 2 mm. However, the size of the substrate 211 is not necessarily limited to this, and may be changed to various sizes.

Additionally, the substrate 211 may be made of a material that has elasticity and can be bent. For example, the substrate 211 may be made of polyurethane (PU), polydimethylsiloxane (PDMS), NOA (Noland Optical Adhesive), epoxy, or polyethylene terephthalate. PET), polymethyl methacrylate (PMMA), polyimide (PI), polystyrene (PS), polyethylene naphthalate (PEN), and polycarbonate (PC) It can be made of material.

However, the material of the substrate 211 is not necessarily limited to this, and electrodes that generate a potential difference according to reaction with COVID antigens may be disposed, and various flexible materials may be used.

The electrode 212 may be provided in plural pieces. The electrode 212 is provided on one side of the substrate 211 and can generate an electrochemical signal by reacting with the COVID antigen contained in the analysis sample. .

The electrode may be a working electrode, a counter electrode, or a reference electrode.

The plurality of electrodes 212 includes a first electrode 212a that oxidizes or reduces a COVID antigen, a second electrode 212b that oxidizes or reduces a COVID antigen in opposition to the reaction of the first electrode 212a, and a third electrode 212c configured to maintain a constant operating voltage between the first electrode 212a and the second electrode 212b.

The plurality of electrodes 212 may be formed on the insulating substrate 211 through a screen printing method. The second electrode 212b and the third electrode 212c may be arranged to surround the first electrode 212a.

The first electrode 212a and the second electrode 212b may be disposed on the substrate 211 to be spaced apart from each other at a certain distance. The first electrode 212a may have a circular shape, and the second electrode 212b may have a semicircular shape to surround a portion of the first electrode 212a. However, the arrangement of the first electrode 212a and the second electrode 212b and the shape of each electrode are not limited thereto and may be changed as needed.

The first electrode 212a may refer to a working electrode that performs an oxidation or reduction reaction by reaction with the COVID antigen or an analysis sample containing the COVID antigen on the substrate 211.

A bioreceptor (not shown) that specifically binds to the COVID antigen may be placed on the first electrode 212a. A pillar on which a conductive layer is deposited is disposed on the first electrode 212a, and bioreceptors such as antibodies, antigens, and aptamers may be disposed on the pillar. A material that induces an electrochemical signal by reacting with COVID antigens may be further disposed on the first electrode 212a.

Through the pillars and bio-receptors disposed on the first electrode 212a and the second electrode 212b, the reaction area with COVID antigens is expanded, and through this, the kit 10 can be used even against a small amount of COVID antigens. It can provide highly sensitive qualitative and quantitative analysis results. Here, the pillar may be a nano-sized polymer structure.

The pillar may be made of at least one of polyurethane, polydimethylsiloxane, NOA (Norland Optical Adhesives), epoxy, polyethylene terephthalate, polymethyl methacrylate, polyimide, polystyrene, polyethylene naphthalate, polycarbonate, and combinations thereof. there is.

Additionally, the pillar may be made of a combination of polyurethane and NOA (eg, NOA 68). However, the pillar is not limited to this and can be made of a variety of polymers as long as it has flexibility.

And, the conductive layer deposited on the pillar may refer to a layer composed of a conductive material. The conductive layer may be made of at least one of Ni, Zn, Pd, Ag, Cd, Pt, Ga, In, and Au, but is not limited thereto.

The second electrode 212b may refer to a counter electrode facing the first electrode 212a on the substrate 211. Therefore, if an oxidation reaction occurs in the first electrode (212a) due to reaction with the COVID antigen, a reduction reaction may occur in the second electrode (212b). The above-described pillar on which a conductive layer is deposited may be disposed on the second electrode 212b.

The third electrode 212c may refer to a reference electrode whose potential is maintained stably even when in contact with a COVID antigen. A reactive layer that can maintain a constant potential even when in contact with COVID antigen may be provided on the third electrode 212c.

The reaction layer is Ag/AgCl, Ag, Hg2SO4, Ag/Ag+, Hg/Hg2SO4, RE-6H, Hg/HgO, Hg/Hg2Cl2, Ag/Ag2SO4, Cu/CuSO4, KCl saturated calomel half cell (SCE) and salt bridge. Platinum can be made of a material whose potential difference is known in advance.

Referring to FIG. 2, the microwell or nanowell structure 220 is provided on the electrode 212 and consists of a plurality of grooves. The microwell or nanowell structure 220 can be provided at the inlet where the analysis sample is inserted into the sensing module 200, and resolution is improved by using the microwell or nanowell structure 220. There is an advantage to being able to do it.

Specifically, the microwell or nanowell structure 220 may be provided on a working electrode, and the microwell or nanowell structure 220 may be provided on the first electrode 212a consisting of a working electrode. It may be provided at the top.

Additionally, the microwell or nanowell may have a diameter of 50 nm to 50 ㎛. As used herein, the term “nanowell” may refer to a well with a well diameter in nanometers (nm), and the term “microwell” may refer to a well with a well diameter in micrometers (㎛). there is. Specifically, nanowells have a diameter of 50 nm to 1000 nm, 50 nm to 900 nm, 50 nm to 600 nm, 50 nm to 500 nm, 100 nm to 1000 nm, 100 nm to 900 nm, 100 nm to 600 nm, may be 100 nm to 500 nm, 200 nm to 1000 nm, 200 nm to 900 nm, 200 nm to 600 nm, 200 nm to 500 nm, 300 nm to 1000 nm, 300 nm to 900 nm or 300 nm to 500 nm; , microwells have a diameter of 1 ㎛ to 50 ㎛, 1 ㎛ to 30 ㎛, 1 ㎛ to 20 ㎛, 5 ㎛ to 50 ㎛, 5 ㎛ to 30 ㎛, 5 ㎛ to 20 ㎛, 10 ㎛ to 50 ㎛, 10 ㎛ It may be from 30 μm to 30 μm, from 20 μm to 50 μm, or from 30 μm to 50 μm.

The sensing module 200 according to an embodiment of the present invention may further include a connection pad 230, a connection port 240, a housing 250, and a bonding wire 260.

The connection pad 230 may be provided singly or in plural pieces, and may be electrically connected to the sensor 210 through the bonding wire 260. 3 and 5, on the bottom of the sensor 210, a plurality of connection pads 230 and a plurality of electrodes 212 provided on the sensor 210 are electrically connected to each other. ) may be provided further.

One side of the connection pad 213 attached to the bottom of the sensor 210 is electrically connected to the plurality of electrodes 212 provided on the sensor 210, and the other side of the connection pad 213 is It may be electrically connected to the plurality of connection pads 230 through a bonding wire 260. Specifically, the plurality of connection pads 230 and the connection pad 213 are provided in the form of copper foil, and the surfaces of the plurality of connection pads 230 may be further coated with gold foil.

Additionally, the connection pad 213 and the sensor 210 may be electrically connected to each other through a conductive material (not shown), and the conductive material may be double-sided adhesive carbon tape or the like. However, the conductive material is not limited to this, and of course, various materials can be used as long as the connection pad 213 and the sensor 210 can be electrically connected.

The bonding wire 260 is made of gold (Au), and one end of the bonding wire 260 is bonded to the connection pad 213 attached to the sensor 210 and is provided in the sensor 210. It is electrically connected to the electrodes 212, and the other end of the bonding wire 260 is bonded to the plurality of connection pads 230 to be electrically connected to the plurality of connection pads 230.

Referring to Figures 2 and 3, the connection port 240 is electrically connected to the plurality of connection pads 230, and can be coupled to the connection module 100 to be electrically connected to the connection module 100. There is.

The connection port 240 may be electrically connected to the plurality of connection pads 230 through a wire 261, and when coupled to the connection module 100, the sensor ( Power can be supplied to 210) and the electrical signal generated by the sensor 210 can be transmitted to the connection module 100. The connection port 240 may be provided in a form corresponding to the second connection terminal 120 provided in the connection module 100.

The housing 250 is installed with the sensor 210, a plurality of connection pads 230, and the connection port 240. The housing 250 includes the sensor 210 and a plurality of connection pads ( 230), may be configured to surround the circumference of the connection port 240 to protect the sensor 210, the plurality of connection pads 230, and the connection port 240 from the outside.

The housing 250 is disposed opposite to a first member 251 provided with a channel 253 that guides an externally provided analysis sample to the electrode 212 of the sensor 210. It is coupled to the first member 251 and includes a second member 252 on which the sensor 210, the plurality of connection pads 230, and the connection port 240 are seated.

The channel 253 is a hole formed through the first member 251, and the channel 253 is an inclined surface 254 for guiding an analysis sample provided from the outside to the electrode 212 of the sensor 210. ) includes. The inclined surface 254 may be provided along the circumference of the channel 253, and the analysis sample provided from the outside moves along the inclined surface 254 and stably flows to the electrode 212 of the sensor 210. can be reached.

Here, referring to FIG. 4, the channel 253 may be provided with the microwell or nanowell structure 220. The microwell or nanowell structure 220 may be provided on the first electrode 212a - the working electrode, and the channel 253 is the first electrode 212a - the working electrode. It may be provided on top of the (working electrode).

Therefore, the microwell or nanowell structure 220 is preferably provided in the channel 253, and the microwell or nanowell structure 220 can be supported while coupled to the channel 253. By providing the microwell or nanowell structure 220 in the channel 253, resolution can be improved when the analyzed sample is moved to the electrode 212 through the channel 253.

The first member 251 is coupled to the second member 252 and covers the sensor 210 and the connection port 240 disposed on the second member 252 to protect them from the outside. . Additionally, the first member 251 may firmly support the sensor 210 and the connection port 240 by pressing them with a predetermined force. In addition, the first member 251 prevents the analysis sample provided to the sensor 210 through the channel 253 from leaking to the outside of the housing 250 through combination with the second member 252. can do.

Referring to Figures 3 and 5, between the first member 251 and the second member 252, the sensor 210, a plurality of connection pads 230, and the connection port 240 are accommodated. And, an accommodation space 250a that protects the bonding wire 260 may be provided. The receiving space 250a may be provided in the form of an engraved pattern inside the first member 251 and the second member 252, respectively.

Referring to FIG. 4, the second member 252 is coupled to the first member 251 and is provided with at least one coupling protrusion 252a to support the first member 251, and the second member 252 is coupled to the first member 251. One member 251 may be provided with at least one coupling groove 251a corresponding to the coupling protrusion 252a.

When the coupling protrusion 252a and the coupling groove 251a are combined, the center of the channel 253 and the center of the sensor 210 can be naturally aligned at a predetermined position. Inside the coupling groove (251a), when the coupling protrusion (252a) is inserted into the coupling groove (251a), a sealer made of rubber or silicone is placed to airtightly between the coupling protrusion (252a) and the coupling groove (251a). may be further provided.

Referring to FIG. 4, the second member 252 includes a seating groove 252b in which the sensor 210 is seated and supported, and a collection groove 252c in which the analysis sample flowing down to the outside of the sensor 210 is stored. This can be further provided. A sample guide surface 252d may be further provided between the sensor 210 and the collection groove 252c to guide the analysis sample flowing outside the sensor 210 toward the collection groove 252c, and the sample guide surface 252d may be further provided. (252d) may have an inclined shape.

Referring to Figures 2 and 3, the housing 250 is configured to control the flow state of the analysis sample, whether the analysis sample is leaking, the alignment state of the channel 253 and the sensor 210, and the bonding wire 260. The connection state of the sensor 210 and the plurality of connection pads 230 and the electrical connection state of the plurality of connection pads 230 and the connection port 240 are made of a transparent material to facilitate observation from the outside. It can be.

For example, the housing 250 is made of at least one of polymethyl methacrylate, polycarbonate, cyclic olefine copolymer, polyethylene sulfone, and polystyrene, or at least two of these. It can be prepared from these combined materials. However, the material of the housing 250 is not necessarily limited to this, and may be made of polydimethylsiloxane, a silicon-based organic polymer.

A kit using a microwell or nanowell structure according to an embodiment of the present invention may be modified and used as follows.

Referring to FIG. 6, a plurality of the sensing modules 200 of the kit according to an embodiment of the present invention may be provided, and the plurality of the sensing modules 200 may be detachably coupled to the connection module 100. You can. That is, the connection module 100 may be electrically connected to a plurality of the sensing modules 200.

To this end, the connection module 100 includes a first connection terminal 110 that can be coupled to the external device 20 and a second connection terminal 120 that can be coupled to the sensing module 200. A plurality of second connection terminals 120 may be provided. The plurality of sensing modules 200 may be selectively coupled to the plurality of second connection terminals 120.

In this way, if a plurality of the sensing modules 200 are provided and a plurality of the second connection terminals 120 are provided, there is an advantage that multiple tests can be performed at once by detecting different COVID antigens.

Here, when the plurality of sensing modules 200 are all connected to the plurality of second connection terminals 120 to generate an electrical signal, the controller 130 connects the plurality of the second connection terminals 120 through the plurality of second connection terminals 120. After remembering the order in which the electrical signals are transmitted, the electrical signals of the sensing module 200 connected to the corresponding second connection terminal 120 can be sequentially received and transmitted to the first connection terminal 110.

The connection module 100 includes a power supply unit 150 that controls the connection between the plurality of second connection terminals 120 and the controller 130. may further include.

There may be a plurality of power units 150 and may be individually connected to a plurality of second connection terminals 120. Additionally, the power unit 150 may be connected to each of the controllers 130.

The power unit 150 can be configured to be controlled ON/OFF through user manipulation, and is connected to the second connection terminal 120 only when the power unit 150 is controlled to the ON state through user manipulation. Electrical signals from the connected sensing module 200 may be transmitted to the controller 130.

Referring to FIGS. 6 and 7, the connection module 100 is installed around the first connection terminal 110 and includes an angle adjusting unit that allows the first connection terminal 110 to rotate by a preset angle. 160) may further be included.

The angle adjusting unit 160 is installed on the main body 140 and a rotating member 161 that is coupled to the first connection terminal 110 and configured to rotate together with the first connection terminal 110, and is installed on the inside of the main body 140. The rotating member 161 may include a guide member 162 that is accommodated and guides the rotation of the rotating member 161.

A plurality of protrusions 161a spaced apart from each other are provided on the outer peripheral surface of the rotating member 161, and a plurality of grooves 162a corresponding to the plurality of protrusions 161a are provided on the inner peripheral surface of the guide member 162. You can. Accordingly, the user can rotate the main body 140 while the first connection terminal 110 is coupled to the external device 20 to place the plurality of second connection terminals 120 at a predetermined position. there is.

Referring to Figure 8, according to an embodiment of the present invention, the connection module 100 and the sensing module 200 can be detachably coupled to each other through magnetism and can be electrically connected to each other through surface contact. .

For this purpose, the connection module 100 may be provided with a first coupling member 170, and the sensing module 200 may be provided with a second coupling member 270 capable of being coupled to the first coupling member 170. .

Referring to FIG. 9, the first coupling member 170 includes a coupling protrusion 171 protruding from one end of the connection module 100 and a first magnetic body 172 accommodated at the end of the coupling protrusion 171. It can be included.

The coupling protrusion 171 may be formed in a wedge structure whose outer diameter gradually decreases along the protruding direction. Through this, when the connection module 100 and the sensing module 200 are coupled, the inclined outer peripheral surface of the coupling protrusion 171 forms a coupling groove of the second coupling member 270 provided on the sensing module 200. It can be guided to the inner peripheral surface of (271) and easily combined.

The second coupling member 270 is formed concavely at the other end of the sensing module 200 facing one end of the connection module 100 and the inner side of the coupling groove 271. It may include a second magnetic material 272 that is accommodated in and can be coupled to the first magnetic material 172 through magnetic force.

The connection module 100 and the sensing module 200 are primarily coupled through structural coupling of the coupling protrusion 171 and the coupling groove 271, and the first magnetic body 172 and the second magnetic material 172 As they are secondaryly coupled through coupling using the magnetism of the magnetic material 272, they can be stably fixed to each other.

Referring to FIG. 8, the sensing module 200 is provided with a device to shield the magnetic force of the second magnetic material 272 so that the magnetic force of the second magnetic material 272 does not affect other parts of the sensing module 200. A shielding structure 280 configured to be provided may be provided.

The shielding structure 280 may be provided inside the housing 250 and may be provided in a form surrounding the coupling groove 271 of the second coupling member 270 and the circumference of the second magnetic material 272. there is. The shielding structure 280 may be made of the same material as the housing 250, but may be made of a material capable of shielding magnetic force.

According to an embodiment of the present invention, the connection module 100 and the sensing module 200 may be electrically connected to each other through surface contact coupling. Referring to FIG. 8, the second connection terminal 120 of the connection module 100 connected to the connection port 240 of the sensing module 200 is a flat plate type that can be electrically connected to each other through surface contact. It may be provided in the form of a terminal.

When the first coupling member 170 of the connection module 100 and the second coupling member 270 of the sensing module 200 are coupled to each other, the connection port 240 and the second connection terminal 120 ) can be electrically connected to each other simply by being touched.

This makes it easier to combine and separate the connection module 100 and the sensing module 200, and prevents the connection port 240 and the second connection terminal 120 from being damaged even in a detachable type. There will be.

An identification film may be attached to the end of the sensing module 200 according to an embodiment of the present invention, enabling confirmation of whether the sensing module 200 is being used through damage. At the end of the sensing module 200, a receiving groove (not shown) is provided that can be combined with a wedge-shaped pressing protrusion (not shown) provided at the end of the connection module 100, and at the entrance of the receiving groove, the sensing module ( The identification film in the form of a thin film that is attached to the end of 200) and is configured to block the entrance of the receiving groove may be attached.

The identification film may be configured to be damaged by being pressed with a predetermined force by the pressing protrusion of the connection module 100 inserted into the receiving groove when the sensing module 200 and the connection module 100 are coupled. Accordingly, the user can determine whether the sensing module 200 is being used by checking whether the identification film provided at the end of the sensing module 200 is damaged. However, the configuration that can check whether the sensing module 200 is being used is not necessarily limited to this, and may be changed and applied in various forms.

Referring to FIG. 10, the sensing module 200 according to an embodiment of the present invention may include a plurality of sensing units configured to detect COVID antigens from an analysis sample. The plurality of sensing units are electrically connected to the connection port 240 and may be installed inside the housing 250.

Each of the plurality of sensing units includes the sensor 210, and the plurality of sensing units are separated from each other through a partition wall 214, and are connected through the connection port 240 that can be electrically coupled to the connection module 100. They can be electrically connected to each other.

The plurality of sensing units may include a first sensing unit 210a and a second sensing unit 210b. The first sensing unit 210a and the second sensing unit 210b may be arranged in spaces independent of each other through the partition wall 214 provided in the housing 250.

The first sensing unit 210a and the second sensing unit 210b each detect COVID antigens from the contacted analysis sample, and the sensor 210 and the bonding wire react with the COVID antigens to generate an electrical signal. It may include the connection pad 230 that is electrically connected to the sensor 210 through 260 and to the connection port 240 through the wire 261.

In addition, the first sensing unit 210a and the second sensing unit 210b may each be provided with the channel 253, and each channel 253 may include the microwell or nanowell structure 220. may be provided.

In addition, each of the first sensing unit 210a and the second sensing unit 210b has a connection between the connection pad 230 and the connection port 240. A power supply unit 290 that controls connection may be further provided.

The power unit 290 is electrically connected to the connection pad 230 and the connection port 240, and may be configured to be controlled ON/OFF through user manipulation. Accordingly, only when the power unit 290 is controlled to the ON state through user manipulation, the electrical signal of the sensor 210 connected to the connection pad 230 can be transmitted to the connection port 240.

The kit using a microwell or nanowell structure according to an embodiment of the present invention has been described as including the first sensing unit 210a and the second sensing unit 210b, but is not limited thereto, and includes two The above sensing unit may be provided.

The kit using the microwell or nanowell structure according to the above-described embodiment of the present invention has the following effects.

The kit 10 using a microwell or nanowell structure according to an embodiment of the present invention is configured to be electrically connected to the external device 20 through a connection terminal provided in the form of a USB or pin, so it can be applied to various devices. , not only can costs be reduced, but it can also be easily used in real life, increasing convenience and usability of the product.

In addition, the kit 10 using a microwell or nanowell structure according to an embodiment of the present invention includes a connection module 100 that is electrically connected to the external device 20, and a sensing module that is detachable from the connection module 100. Since it is composed of (200), various types of tests can be performed by replacing the sensing module 200, and only the sensing module 200 can be replaced while the connection module 100 is coupled to the external device 20. Rapid testing can be performed continuously.

In addition, the kit 10 using a microwell or nanowell structure according to an embodiment of the present invention is configured so that the sensing module 200 and the external device 20 are electrically connected to each other through the connection module 100. , Even when the kit 10 is coupled to or separated from the external device 20, the sensing area is prevented from being damaged by the external device 20.

In addition, by improving the shape of the electrode provided on the substrate 211 applied to the kit 10 using a microwell or nanowell structure according to an embodiment of the present invention, a larger quantity of sensors 210 can be installed than before. Manufacturing becomes possible, and manufacturing costs can be reduced.

Specifically, by improving the shape of the electrode provided on the substrate 211, the sensor 210 can be manufactured in a size of 2 x 2 mm. Accordingly, the number of sensors 210 that can be manufactured using an existing 8-inch wafer has increased significantly from as few as 1,000 to as many as 20,000. Except for the sensor 210, manufacturing costs can be further reduced by using a PCB process with a low manufacturing cost.

In addition, the kit 10 using a microwell or nanowell structure according to an embodiment of the present invention has the advantage of improving resolution by inserting an analysis sample through the microwell or nanowell structure 220. .

Example 1. COVID antigen measurement

1-1. experiment material

Accessories include nanowell electrode (USB Type) (manufactured by Mara Nanotech Korea Co., Ltd.), portable electrochemical meter (manufactured by Mara Nanotech Korea Co., Ltd.), millisize electrode (USB Type) (manufactured by Mara Nanotech Korea Co., Ltd.), and microwell electrode (USB Type). ) (manufactured by Marananotech Korea Co., Ltd.) was used, and the reagents were DTSSP (purchased from THERMO), Detection antibody (biotin conjugate) (purchased from abclon), Detection antibody (HRP conjugate) (purchased from abclon), and COVID S protein (purchased from abclon). (purchased from), 1xPBS (purchased from Dubellco), 0.05% Tween 20 in 1xPBS, DI water, potassium ferricyanide (purchased from Sigma Aldrich), and bovine serum albumin (BSA) (purchased from Thermo) were used.

1-2. COVID antigen measurement steps

To diagnose COVID, COVID antigens were measured as follows.

Specifically, (1) electrode cleaning and initialization verification step, (2) self assembled monolayer (SAM) processing step, (3) antigen immobilization step, (4) detection antibody immobilization step, (5) washing step, (6) electrolysis. It was measured through a signal measurement step.

First, (1) the electrode cleaning and initialization verification steps were specifically performed as follows.

First, the number of electrodes to be tested was prepared according to the concentration to be measured. One electrode is used for one concentration analysis. Before the experiment, the CV, SWV, and CA of the bare electrode were measured for comparative analysis. Nanowell electrodes (USB type) and nanowell electrodes (8 channels) manufactured by Marananotech Korea Co., Ltd. were used.

Before starting the experiment, a 10 mM ferricyadnide solution was prepared in 1xPBS solution and stored at room temperature. The molecular weight was 329.26, so it was prepared according to concentration and stored in a 50 ml tube in a room temperature rack. The prepared solution was checked for any foreign substances before use, and a new solution was prepared and used every 14 days.

Next, the electrode was inserted into MP101, 30ul of 10mM ferricyanide solution was added, and the conditions shown in Table 1 below were applied.

Electrochemical measurements (CV) Potential/current limit (vertexl, 2) repeat Scan rate 08 ~ -0.8 V(CV), microwell No.2 200 mV/s 0.9 ~ -0.9 V (repeated twice), nanowell array electrode No.2 200 mv/s 0.5 ~ -0.7 V metric (can be omitted) No.2 200 mv/s

After measuring the magnitude of the current and the shape of the redox current derived under the above conditions, the pass/fail rate was determined. Afterwards, the used electrode was cleaned by running DI WATER on it for 3 seconds and the remaining material was blown away with a pump to prepare for the experiment.

Next, (2) Self assembled monolayer (SAM) processing step was performed as follows. This step is for improving orientation and density.

First, 10 mM DTSSP was dissolved in DI water to create a solution in EP TUBE. Since DTSSP is a material sensitive to moisture and light, it was immediately taken out of the refrigerator, weighed, made into a solution, and immediately refrigerated after use.

Since 30 ul of DTSSP is required per electrode, prepare according to the number (for example, 300 ul for 10 electrodes), and 30 ul of DTSSP was dropped on the electrode to cover the entire electrode area and incubated at room temperature for 60 minutes. At this time, to prevent the DTSSP on the electrode from drying out, humidity was maintained by using a water bath or by placing water-filled tissues in the storage box. Also, when dispensing, avoid touching the upper part of the electrode surface with the pipette.

Next, (3) the antigen immobilization step was performed as follows.

As a positive standard, COVID S protein diluted in 5% BSA solution was dispensed onto the electrode and incubated for 30 minutes. At this time, the humidity was maintained as in step (2) above. Also, when dispensing, avoid touching the upper part of the electrode surface with the pipette. Only 5% BSA solution was used as a negative standard material. After a certain period of time, the solution was removed by rolling with a cotton swab.

Next, (4) the detection antibody immobilization step was performed as follows.

HRP (Horseradish peroxidase) labeled antibody was used as a detection antibody. The detection antibody was dispensed onto the electrode at a concentration of 1 ug/ml and incubated for 30 minutes. At this time, the humidity was maintained as in step (2) above. Also, when dispensing, the upper part of the electrode surface was avoided with the pipette, and since HRP-labeled antibodies are sensitive to light, they were wrapped in silver foil and incubated. After a certain period of time, the solution was removed by rolling with a cotton swab.

Next, the (5) washing step was performed as follows.

50ul of 1xPBST was dispensed onto the electrode for 5 seconds to wash away the residue. After a certain period of time, the solution was removed by rolling or absorption with a cotton swab.

Finally, step (6) measuring electrical signals was performed as follows.

OPD (o-phenylenediamine) or TMB (3,3',5,5'-Tetramethylbenzidine) was used as a reagent. The OPD used is in tablet form and is divided into two types: A (OPD, silver, small tablet) and B (Buffer with urea H2O2, gold, large tablet) and stored in a refrigerator. First, tablet B was dissolved in 20 ml of DI water, and when it was completely dissolved, A was added to create a solution. 30ul of OPD was dropped on the reacted electrode and reacted for 5 minutes. Additionally, in the case of TMB, a stock solution was used and 30ul was dropped on the electrode where the reaction was completed and reacted for 5 minutes.

The electrode on which OPD or TMB was placed was inserted into mp101 under the electrochemical conditions shown in Table 2 below, and the current was measured.

CA SMV Quiet Time(s) 0 Sensitivity 100uA Quiet Time(s) 0 Initial Volt(mV) 0 Wave Type Single Volt Delta(mV) 5 One ^st Time(s) 10s One ^st Volt(mV) -0.9V Increase Volt(mV) 25 2 ^nd Tims(s) 2 ^nd Volt(mV) Initial Volt(mV) -0.8 Numbers of Steps One Final Voltage (mV) 0 Sample Interval (Hz) Sensitivity 1 mA Frequency (Hz) 10

Experimental Example 1.

In the antigen immobilization step (3), 25 ul of positive and negative standard materials were used, and after a certain period of time, the solution was removed by rolling with a cotton swab. (4) In the detection antibody immobilization step, 0.5 or 25 ul of detection antibody was used. (5) In the washing step, the solution was removed by absorbing it with a cotton swab. All other methods were carried out in the same manner as Example 1-2 above.

The measurement results are shown in Figure 12.

Experimental Example 2.

In the antigen immobilization step (3), 25 ul of positive and negative standard materials were used, and after a certain period of time, the solution was removed by rolling with a cotton swab. (4) In the detection antibody immobilization step, 0.5 or 25 ul of detection antibody was used. (5) In the washing step, the solution was removed by rolling with a cotton swab. All other methods were carried out in the same manner as Example 1-2 above.

The measurement results are shown in Figure 13.

Experimental Example 3.

In the antigen immobilization step (3), 15 ul of positive and negative standard materials were used, and the solutions were not removed separately with a cotton swab. (4) In the detection antibody immobilization step, 15 ul of detection antibody was used. (5) In the washing step, the solution was removed by absorbing it with a cotton swab. All other methods were carried out in the same manner as Example 1-2 above.

The measurement results are shown in Figure 14.

Experimental Example 4.

In the antigen immobilization step (3), 15 ul of positive and negative standard materials were used, and the solutions were not removed separately with a cotton swab. (4) In the detection antibody immobilization step, 15 ul of detection antibody at 2 ug/ml was used. (5) In the washing step, the solution was removed by absorbing it with a cotton swab. All other methods were carried out in the same manner as Example 1-2 above.

The measurement results are shown in Figure 15.

10...kit 20...external device
100...connection module 110...first connection terminal
120...second connection terminal 130...controller
140...main body 150...power unit
160...Angle adjustment unit 161...Rotating unit
162...guiding member 170...first coupling member
171...binding protrusion 172...first magnetic material
200...sensing module 210...sensor
211...substrate 212...electrode
212a... first electrode 212b... second electrode
212c...third electrode 213...connection pad
214...diaphragm 220...microwell or nanowell structure
230...connection pad 240...connection port
250...housing 250a...accommodating space
251... first member 251a... coupling groove
252...second member 252a...combining protrusion
252b... Seating groove 252c... Collection groove
252d...sample guide surface 253...channel
254...slope 260...bonding wire
261...wire 270...second coupling member
271...combining groove 272...second magnetic material
280...shielding structure 290...power unit

Claims (12)

A connection module that can be electrically connected to an external device; and
In the diagnostic kit including a sensing module configured to detect COVID antigens from an analysis sample introduced therein and transmit an electrical signal generated in response to the detected COVID antigens to the connection module,
The sensing module is provided with a sensor that detects the COVID antigen from the analysis sample and reacts with the COVID antigen to generate the electrical signal,
The sensor includes: a substrate; and a plurality of electrodes provided on one side of the substrate and reacting with the COVID antigen to generate an electrochemical signal,
A diagnostic kit for diagnosing COVID, wherein the sensing module is attachable and detachable from the connection module. The diagnostic kit for diagnosing COVID according to claim 1, wherein the sensor includes a microwell or nanowell structure consisting of a plurality of grooves on the upper part of the electrode. The diagnostic kit for diagnosing COVID according to claim 1, wherein the analysis sample is a biological sample isolated from an individual. The diagnostic kit for diagnosing COVID according to claim 1, wherein the sensor is not coated with a material capable of detecting the COVID antigen by reacting with the COVID antigen. The diagnostic kit for diagnosing COVID according to claim 1, wherein the electrochemical signal is generated by further adding a probe capable of binding to the COVID antigen and an electron transfer activating material. The diagnostic kit for diagnosing COVID according to claim 5, wherein the probe capable of binding to the COVID antigen is a COVID antibody. The diagnostic kit for diagnosing COVID according to claim 1, wherein the electrode is a working electrode, a counter electrode, or a reference electrode. The diagnostic kit for diagnosing COVID according to claim 1, wherein the microwell or nanowell has a diameter of 50 nm to 50 ㎛. The diagnostic kit for diagnosing COVID according to claim 1, wherein the connection module and the sensing module are detachably coupled to each other through magnetism and electrically connected to each other through surface contact. The diagnostic kit for diagnosing COVID according to claim 1, wherein the sensing module is one or more, and the one or more sensing modules are attachable and detachable from one of the connection modules. Applying an analysis sample to the electrode of the diagnostic kit of claim 1;
Applying a probe capable of binding to a COVID antigen to the electrode to which the analysis sample is applied;
Applying an electron transport activating material to the electrode to which the probe is applied; and
A method of providing information for diagnosing COVID, comprising measuring an electrical current. The method of claim 11, wherein the analysis sample is a biological sample isolated from an individual.