Biosensor structure for analyte measurement and analyte measurement method using the same

The biosensor structure addresses inaccuracies in analyte measurement by using a spaced electrode arrangement and a filter to remove interfering substances, enhancing the accuracy of glucose detection in saliva.

JP7752879B2Active Publication Date: 2025-10-14DONG WOON ANATECH CO LTD
View PDF 14 Cites 0 Cited by

Patent Information

Application Number
JP2023519395
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2021-08-10
Filing Date
2021-09-28
Publication Date
2025-10-14
Estimated Expiration
2041-09-28

AI Technical Summary

Technical Problem

Conventional biosensors face inaccuracies in analyte measurement due to the formation of an electric double layer (EDL) at the electrode surfaces and variations in sample sedimentation times, which distort measurement signals and affect accuracy.

Method used

A biosensor structure with a working electrode and reference electrode spaced apart and alternately arranged, along with a recognition electrode, is used to measure analytes like glucose in saliva, incorporating a filter to remove interfering substances and an enzyme compound for accurate measurement.

Benefits of technology

The biosensor structure improves measurement accuracy by removing interfering substances and using an enzyme compound to enhance the detection of glucose in saliva, reducing distortions from EDL and sedimentation variations.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure 0007752879000001
    Figure 0007752879000001
  • Figure 0007752879000002
    Figure 0007752879000002
  • Figure 0007752879000003
    Figure 0007752879000003
Patent Text Reader

Abstract

A biosensor structure for analyte measurement and a method for measuring analyte using the same are provided. A biosensor electrode structure according to one embodiment of the present invention is a biosensor electrode structure for analyte measurement, in which a working electrode and a reference electrode for measuring analyte are disposed spaced apart from each other along the length of a sample insertion channel, and a working protrusion of the working electrode and two reference protrusions of the reference electrode are alternately arranged in a portion corresponding to the sample insertion channel, the ratio of the area of ​​the working protrusions to the area of ​​the reference protrusions being 1 or greater, and at least one recognition electrode for recognizing the analyte is disposed adjacent to the working electrode or the reference electrode and parallel to the working electrode and the reference electrode at a distance, and the at least one recognition electrode has at least one recognition protrusion disposed in a portion corresponding to the sample insertion channel.
Need to check novelty before this filing date? Find Prior Art

Description

[Technical Field]

[0001] The present invention relates to a biosensor structure for measuring an analyte and an analyte measurement technique using the same, and more particularly to a biosensor structure and an analyte measurement method using the same that can improve the measurement accuracy of an analyte, for example, glucose contained in saliva. [Background technology]

[0002] Quantitative and qualitative analysis of analytes present in biosamples is an important element in both chemistry and clinical applications, such as measuring blood glucose levels in diabetic patients and cholesterol levels, which are factors contributing to adult diseases.

[0003] Electrochemical biosensors that utilize enzyme activity, which are well known in the field, are extremely important for improving speed and reproducibility in measuring enzyme activity of specific substances in biological samples (hereinafter referred to as "analytes"), such as saliva or blood, such as glucose sensors, uric acid sensors, protein sensors, DNA sensors, and sucrose sensors in clinical chemistry tests, and GOT (Glutamate-Oxaloacetate Transaminase) and GPT (Glutamate-Pyruvate Transaminase) in liver function tests. Here, the biosensor is composed of an identification portion that identifies the measurement target and a change portion that converts it into an electrical signal.

[0004] A biological substance is used in the recognition region, and when the biological substance recognizes the target, a chemical or physical change occurs. The region that converts this change into an electrical signal is called the change region, and the recognition region and change region are collectively called the biosensor electrode.

[0005] The measurement method for strip-type biosensors currently in common use is to use capillary action, a force stronger than gravity that is made possible by plasma or chemical surfactant treatment during the manufacturing process, to introduce the sample into the sample insertion channel of the biosensor, accumulate the sample in the sample insertion channel, and then measure the sample qualitatively or quantitatively.

[0006] In this case, typically, prior to the sample measurement, a step of detecting the sample inflow time, which is the time when the sample flows in and accumulates in the sample insertion channel, is performed.

[0007] In conventional biosensors, a sample inflow detection signal is applied to the working electrode and reference electrode of a biosensor to detect the sample inflow time, and a sample measurement signal is applied to the working electrode and reference electrode after a certain time has passed to measure the sample. That is, the sample inflow time is determined by calculating the time when the sample reaches the working electrode and reference electrode and then completely fills the flow path formed by the sample being inserted. After waiting for a certain time, the sample measurement signal is applied to the working electrode and reference electrode to measure the sample.

[0008] In this case, a problem occurs in that the analyte inflow detection signal applied to detect the point of analyte inflow reacts with the surfaces of the working electrode and reference electrode, which are important measurement electrodes, to form an electric double layer (EDL). An electric double layer appears at the boundary between different materials (electrode, analyte, or solution) when an electric field is applied to the surface of adjacent materials. Although the electric double layer capacitance (DLC), which is the storage capacity of the electric double layer, is small, it may be included in the current signal measured when the analyte detection signal is applied. This distorts the measurement signal of the biosensor, affecting the measurement results.

[0009] Furthermore, if the measurement is performed after waiting a predetermined time calculated from the time of sample inflow to the time of sample sedimentation in the flow channel, the viscosity of each sample varies, even if only by a small amount, depending on the speed or time at which the sample sediments in the flow channel, which can affect the measurement results. Therefore, determining the time at which the sample measurement signal is applied using time control can cause significant problems in the accuracy of the measurement. Summary of the Invention [Problem to be solved by the invention]

[0010] SUMMARY OF THE INVENTION An embodiment of the present invention provides a biosensor structure and an analyte measurement method using the same that can improve the measurement accuracy of an analyte, for example, glucose contained in saliva.

[0011] An embodiment of the present invention provides a sample measurement system that can improve the accuracy of measurement of substances contained in a sample by collecting a sample, removing interfering substances that hinder sample measurement from the collected sample, and then measuring the sample using a biosensor. [Means for solving the problem]

[0012] In accordance with one embodiment of the present invention, a biosensor electrode structure for measuring an analyte includes a working electrode and a reference electrode for measuring an analyte, the working electrode and the reference electrode being spaced apart from each other along the length of a sample insertion channel, and the working electrode and the reference electrode are alternately arranged in a portion corresponding to the sample insertion channel, with the ratio of the area of ​​the working protrusions to the area of ​​the reference protrusions being 1 or greater. At least one recognition electrode for recognizing the analyte is adjacent to the working electrode or the reference electrode and is spaced apart from the working electrode and the reference electrode in parallel, and the at least one recognition electrode has at least one recognition protrusion in a portion corresponding to the sample insertion channel.

[0013] The recognition protrusion may be disposed adjacent to the terminal end of the sample insertion channel.

[0014] The at least one recognition electrode may perform analyte recognition in response to an analyte recognition signal applied independently of an analyte measurement signal applied to the working electrode and the reference electrode.

[0015] In addition, the biosensor electrode structure according to one embodiment of the present invention may further include a strip recognition electrode for detecting the moment when the biosensor having the biosensor electrode structure is inserted into a meter for measurement.

[0016] According to one embodiment of the present invention, a biosensor structure for measuring an analyte includes a working electrode and a reference electrode for measuring the analyte, and at least one recognition electrode for recognizing the analyte, disposed on an insulating substrate. The working electrode and the reference electrode are spaced apart from each other along the length of a sample insertion channel. In a portion of the sample insertion channel, working protrusions on the working electrode and two reference protrusions on the reference electrode are alternately arranged, with the ratio of the area of ​​the working protrusions to the area of ​​the reference protrusions being 1 or greater. The at least one recognition electrode is structured to be adjacent to the working electrode or the reference electrode and spaced apart from each other so as to be parallel to the working electrode and the reference electrode. The biosensor structure includes a lower plate having at least one recognition protrusion disposed in a portion of the sample insertion channel, a middle plate having the sample insertion channel formed therein and into which an enzyme compound is inserted, and an upper plate having an insertion port for inserting the sample and an outlet port for discharging air formed in a portion of the insulating substrate corresponding to the sample insertion channel.

[0017] When the sample is saliva, the enzyme compound includes an enzyme for selectively reacting with glucose contained in the saliva, a polymer for attaching the enzyme to the electrode disposed on the lower plate, and a catalyst for promoting the reaction of the enzyme with the glucose. The enzyme includes 1 to 30 units of at least one of glucose oxidase and glucose dehydrogenase (GDH), and the polymer is selected from the group consisting of chitosan, PVP, Nafion, polyethylene glycol, polyvinyl pyrrolidone, and polyvinyl The catalyst may contain 0.01 to 1.0% by weight of at least one of alcohol, agarose, and trehalose, and the catalyst may contain 1 to 10% by weight of at least one of ferrocene, a ferrocene derivative, quinone, a quinone derivative, hexaamine ruthenium (III) chloride, and a ferricyanide compound.

[0018] The catalyst may contain 0.001 to 5% of the Prussian blue.

[0019] The at least one recognition electrode may perform analyte recognition in response to an analyte recognition signal applied independently of an analyte measurement signal applied to the working electrode and the reference electrode.

[0020] A sample measurement system according to one embodiment of the present invention includes a collection device including a collection means for collecting a sample, a collection device including a filter for removing interfering substances that hinder sample measurement from the sample collected by the collection means, and a working electrode and a reference electrode for measuring the sample from which the interfering substances have been removed. the working electrode and the reference electrode are spaced apart from each other in the longitudinal direction of the sample insertion flow channel, and in a portion corresponding to the sample insertion flow channel, working protrusions that are protrusions of the working electrode and two reference protrusions that are protrusions of the reference electrode are alternately arranged, and the ratio of the area of ​​the working protrusions to the area of ​​the reference protrusions is 1 or more, and the at least one recognition electrode has a structure in which it is adjacent to the working electrode or the reference electrode and is spaced apart from each other so as to be parallel to the working electrode and the reference electrode, and the at least one recognition electrode is arranged in a portion corresponding to the sample insertion flow channel; and a measurement device that, when a sample from which the interferents have been removed is inserted into the biosensor by the collection device after a strip of the biosensor is inserted, measures the sample from which the interferents have been removed based on a sample measurement signal received through the working electrode and the reference electrode.

[0021] When the sample is saliva, the filter may remove large molecules and foreign matter present in the saliva, and separate substances including proteins, amylases, and ions that may interfere with glucose measurement in the saliva.

[0022] The biosensor may include a lower plate having the electrode structure, a middle plate in which the sample insertion channel is formed and an enzyme compound is inserted into the sample insertion channel, and an upper plate in which an insertion port for inserting the sample from which the interfering substances have been removed and an outlet port for discharging air are formed in a portion corresponding to the sample insertion channel.

[0023] When the sample is saliva, the enzyme compound includes an enzyme for selectively reacting with glucose contained in the saliva, a polymer for attaching the enzyme to the electrode disposed on the lower plate, and a catalyst for promoting the reaction of the enzyme with the glucose. The enzyme includes 1 to 30 units of at least one of glucose oxidase and glucose dehydrogenase (GDH), and the polymer is selected from the group consisting of chitosan, PVP, Nafion, polyethylene glycol, polyvinyl pyrrolidone, and polyvinyl The catalyst may contain 0.01 to 1.0% by weight of at least one of alcohol, agarose, and trehalose, and the catalyst may contain 1 to 10% by weight of at least one of ferrocene, a ferrocene derivative, quinone, a quinone derivative, hexaamine ruthenium (III) chloride, and a ferricyanide compound.

[0024] The catalyst may contain 0.001 to 5% of the Prussian blue.

[0025] A sample measurement method according to one embodiment of the present invention includes the steps of collecting a sample using a collection means, removing interfering substances that interfere with sample measurement from the collected sample using a filter, contacting the sample from which the interfering substances have been removed with a biosensor, and, when the contact of the sample from which the interfering substances have been removed is recognized by at least one recognition electrode of the biosensor, applying a sample measurement signal to a working electrode and a reference electrode of the biosensor to measure a response signal for the sample from which the interfering substances have been removed. The working electrode and the reference electrode may be spaced apart from each other in a longitudinal direction of a sample insertion flow channel, and a portion of the sample insertion flow channel corresponding to the sample insertion flow channel may have working protrusions and two reference protrusions, each of which is a protrusion of the working electrode, alternately arranged, such that the ratio of an area of ​​the working protrusions to an area of ​​the reference protrusions is 1 or greater. The at least one recognition electrode may be adjacent to the working electrode or the reference electrode and spaced apart from the working electrode and the reference electrode so as to be parallel to the working electrode and the reference electrode. At least one recognition protrusion may be disposed in the portion corresponding to the sample insertion flow channel. [Effects of the Invention]

[0026] According to an embodiment of the present invention, a sample, for example, saliva, is collected, and interfering substances that may interfere with sample measurement are removed from the collected sample. Then, glucose contained in the saliva is measured using a biosensor, thereby improving the accuracy of measurement of substances contained in the sample.

[0027] According to an embodiment of the present invention, interfering substances that hinder salivary sugar measurement are removed using a filter, and then the saliva from which the interfering substances have been removed is measured using a biosensor equipped with an enzyme compound, thereby improving the accuracy of salivary sugar measurement. [Brief explanation of the drawings]

[0028] [Figure 1] 1 is an illustrative diagram for explaining a specimen measurement system of the present invention. [Figure 2]2 is a diagram showing a configuration for one embodiment of the collection device shown in FIG. 1. FIG. [Figure 3] 2 is an exemplary view of the biosensor structure shown in FIG. 1; [Figure 4] 4 is an exemplary view of the biosensor electrode structure shown in FIG. 3. [Figure 5] 1 is an illustrative diagram for explaining a specimen measurement method of the present invention. [Figure 6] 1 is an experimental graph showing the concentration of fine sugars measured by the specimen measurement system of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0029] The advantages and features of the present invention, and methods for achieving them, will become clearer with reference to the following detailed embodiments in conjunction with the accompanying drawings. However, the present invention is not limited to the embodiments disclosed below and may be embodied in various different forms. The present embodiments are provided so that the disclosure of the present invention will be complete and will fully convey the scope of the invention to those skilled in the art. The present invention is defined solely by the claims.

[0030] The terms used herein are merely for the purpose of describing embodiments and are not intended to limit the present invention. The singular forms used herein also include the plural forms unless the context clearly dictates otherwise. The terms "comprises" and / or "comprising" used herein do not exclude the presence or addition of one or more other components, steps, operations, and / or elements to the referenced components, steps, operations, and / or elements.

[0031] Unless otherwise defined, all terms (including technical and scientific terms) used herein may be used in the sense that they can be commonly understood by a person of ordinary skill in the art to which the present invention belongs. Furthermore, terms defined in commonly used dictionaries should not be interpreted ideally or excessively unless they are clearly and specifically defined.

[0032] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Preferred embodiments of the present invention will now be described in detail with reference to the accompanying drawings. The same reference numerals are used to refer to the same components in the drawings, and redundant descriptions of the same components will be omitted.

[0033] An embodiment of the present invention is to provide a biosensor that can improve the accuracy of measurement of substances contained in a sample by collecting a sample, for example, saliva, removing interfering substances that hinder sample measurement from the collected sample, and then measuring glucose contained in the saliva using a biosensor, and a sample measurement system using the same.

[0034] Here, when the sample is saliva, the filter for removing interfering substances removes large molecules and foreign matter present in the saliva, and separates substances that interfere with sugar measurement in saliva, such as proteins, amylase, and ions.

[0035] The biosensor is provided with a working electrode and a reference electrode for measuring the analyte, and at least one recognition electrode for recognizing the analyte, the working electrode and the reference electrode are arranged spaced apart from each other along the length of the analyte insertion flow path, and in the portion corresponding to the analyte insertion flow path, the protrusions of the working electrode (hereinafter referred to as "working protrusions") and two protrusions of the reference electrode (hereinafter referred to as "reference protrusions") are arranged alternately, the ratio of the area of ​​the working protrusions to the area of ​​the reference protrusions is 1 or more, and at least one recognition electrode is arranged adjacent to the working electrode or the reference electrode and parallel to the working electrode and reference electrode at a distance, and the biosensor may have an electrode structure in which at least one protrusion (hereinafter referred to as "recognition protrusion") is arranged in the portion corresponding to the analyte insertion flow path.

[0036] In this case, the electrode structure of the biosensor may further include a strip recognition electrode for detecting the moment when the biosensor is inserted into a meter for measurement.

[0037] In such a biosensor, an enzymatic compound is inserted into a middle plate in which a sample insertion channel is formed, and the enzymatic compound may include an enzyme, a polymer, and a catalyst.

[0038] In this case, when the sample is saliva, the enzyme is used to selectively react with glucose contained in the saliva, the polymer is used to attach the enzyme to the electrode arranged in the biosensor, and the catalyst is used to promote the reaction between the enzyme and glucose.

[0039] The present invention will be described with reference to FIGS.

[0040] 1 is an illustrative diagram for explaining a specimen measurement system of the present invention. As shown in Fig. 1, a specimen measurement system 100 according to one embodiment of the present invention includes a sampling device 110, a biosensor 200, and a measurement device 300.

[0041] As shown in FIG. 2, the collection device 100 includes a specimen collection portion 110 including a specimen collection swab 111 for collecting a specimen, a filter 120, and a compression tube 130.

[0042] In this case, if the sample is saliva, the sample collection unit 110 may collect the saliva using a sample collection swab 111, and the saliva collected by the sample collection unit 110 may be provided to the outside, i.e., the biosensor 200, through the compression tube 130 after removing interfering substances contained in the saliva using a filter 120 inserted into the compression tube 130.

[0043] That is, after collecting saliva, the collection device 100 compresses the sample collection section 110 in the compression tube 130 toward the compression tube 130. This removes interfering substances contained in the collected saliva using the filter 120, removes large molecules and foreign matter present in the saliva, and separates substances such as proteins, amylase, and ions that interfere with glucose measurement in the saliva.

[0044] The filter 120 may be composed of at least one layer. Of course, the filter 120 described in the present invention may have additional materials added to the above materials or may have different layer thicknesses depending on the degree to which interfering substances are removed from the sample. Furthermore, when the filter 120 is composed of multiple layers, the filter may be formed by sequentially stacking layers made of different materials.

[0045] When a sample collected by the sampling device 100 is inserted into the sampling device 100, the biosensor 200 performs the function of sensing the information to be measured, such as glucose, from the sample from which interfering substances have been removed.The biosensor strip 200 is inserted into the measuring device 300, and recognizes the sample based on a sample recognition signal received from the measuring device 300, and provides the measuring device 300 with a response signal for the glucose contained in the sample in response to a sample measurement signal applied separately from the sample recognition signal.

[0046] Such a biosensor 200 may be composed of an upper plate 230, a middle plate 220, and a lower plate 210 as shown in FIG. 3, and a biosensor electrode structure is formed on the lower plate 210 as shown in FIG.

[0047] Specifically, a sample insertion channel is formed in the middle plate 220, and an enzyme compound 221 is inserted into the sample insertion channel.

[0048] Here, the sample insertion channel is obvious to those skilled in the art, so a detailed description thereof will be omitted.

[0049] The enzyme compound 221 may include an enzyme for selectively reacting with glucose contained in the sample, a polymer for attaching the enzyme to an electrode arranged on the lower plate, and a catalyst for promoting the reaction between the enzyme and glucose.

[0050] In this case, the catalyst may contain 1 to 10% of at least one of ferrocene, ferrocene derivatives, quinone, quinone derivatives, hexaamine ruthenium (III) chloride, and ferricyanide (when Prussian blue is used, the catalyst may contain 0.001 to 5% of Prussian blue), the enzyme may contain 1 to 30 units of at least one of glucose oxidase and glucose dehydrogenase (GDH), and the polymer may contain 0.01 to 1.0% by weight of at least one of chitosan, PVP, Nafion, polyethylene glycol, polyvinyl pyrrolidone, polyvinyl alcohol, agarose, and trehalose.

[0051] The upper plate 230 is formed on the upper part of the middle plate 220, and the upper plate 230 has an insertion port for inserting the sample collected by the collection device and an outlet port for discharging air at a portion corresponding to the sample insertion channel on the insulating substrate.

[0052] The lower plate 210 has an insulating substrate 211 on which a working electrode 211 and a reference electrode 212, which are electrodes for measuring a sample, and at least one recognition electrode 213 for recognizing the sample are arranged. The working electrode 211 and the reference electrode 212 are arranged at a distance from each other in the longitudinal direction of the sample insertion flow channel. In the portion corresponding to the sample insertion flow channel, working protrusions 211a of the working electrode 211 and two reference protrusions 212a of the reference electrode 212 are arranged alternately. The ratio of the area of ​​the working protrusions 211 to the area of ​​the reference protrusions 212 is 1 or more. At least one recognition electrode 213 is arranged adjacent to the working electrode 211 or the reference electrode 212 and parallel to the working electrode 211 and the reference electrode 212 at a distance. The electrode structure has at least one recognition protrusion 213a arranged in the portion corresponding to the sample insertion flow channel.

[0053] Here, the lower plate 210 may be formed by stacking a plurality of metal layers having such an electrode structure. For example, the lower plate 210 may be formed by stacking a first metal layer 210-2 made of copper, a second metal layer 210-3 made of nickel, and a third metal layer 210-4 made of gold, each having a biosensor electrode structure, on an insulating substrate 210-1.

[0054] Furthermore, as shown in FIG. 4, the biosensor electrode structure may further include a strip recognition electrode 214 at the portion where the biosensor strip is inserted into the measurement device, for detecting the insertion state of the biosensor strip in the measurement device.

[0055] In addition, the working electrode 211 and the reference electrode 212 may be spaced apart from each other along the length of the sample insertion channel, with the electrode width in the portion facing the measurement device 300 being wider than the electrode width in the portion facing the sample insertion channel, and one working protrusion 211a may be arranged alternately between two reference protrusions 212a. By making the area of ​​the working protrusion 211a at least larger than the area of ​​the two reference protrusions 212a, the accuracy of sample measurement can be improved. That is, since salivary sugar is detected at a lower level than blood glucose, by increasing the area of ​​the working protrusion 211a, the response signal due to the sample measurement signal can be accurately measured when saliva comes into contact, thereby improving the accuracy of measurement of salivary sugar.

[0056] Furthermore, the recognition electrode 213 may be disposed between the reference electrode 212 and the working electrode 211, and the recognition protrusion 213a may be formed at the end of the sample insertion channel.

[0057] The distance between the working protrusion 211a and the reference protrusion 212a, the distance between the reference protrusion 212a and the recognition protrusion 213a, and the width of each protrusion may be determined taking into consideration the measurement accuracy for the sample, and may be determined by the individual or business providing this technology.

[0058] When a biosensor strip is inserted into the measuring device 300, the recognition electrode 214 receives a sample recognition signal from the measuring device 300 for recognizing the sample, and the measuring device 300 recognizes the sample based on a response signal to the sample recognition signal.

[0059] When the reference electrode 212, the working electrode 211, and the biosensor strip 200 are inserted into the measurement device 300, an analyte measurement signal for measuring an analyte may be received from the measurement device 300. The analyte measurement signal may be received separately from the analyte recognition signal, and the analyte measurement signal may be received when the biosensor strip 200 is inserted into the measurement device 300 or when the recognition electrode 213 recognizes the analyte. Of course, the measurement device 300 can recognize whether the biosensor strip 200 has been inserted through the strip recognition electrode 214 provided on the biosensor strip 200.

[0060] The analyte measurement signal applied to the reference electrode 212 and the working electrode 211 may be applied to the reference electrode 212 and the working electrode 211 by applying different voltages that are preset as signals corresponding to a certain potential difference to the reference electrode 212 and the working electrode 211.

[0061] When the biosensor strip 200 is inserted, the measuring device 300 recognizes that the biosensor strip 200 has been inserted through the strip recognition electrode 214 provided on the biosensor strip 200, and determines whether a sample has come into contact with the biosensor by providing a sample recognition signal to the recognition electrode 213 of the biosensor.If it determines that a sample has come into contact with the biosensor, it provides a sample measurement signal to the reference electrode 212 and the working electrode 212, receiving a response signal of the sample to be measured and measuring the sample.

[0062] Here, when the sample is saliva, the measurement device 300 may measure salivary sugar.

[0063] Furthermore, the measurement device 300 may provide a numerical result for the measured salivary sugar through a display means and may additionally provide a color for the glucose level.

[0064] FIG. 5 is an illustrative diagram for explaining the sample measurement method of the present invention, illustrating the process of measuring salivary sugar.

[0065] Referring to Figure 5, the sample measurement method will be described. As shown in Figures 5a and 5b, saliva from a subject is collected using the sample collection part of the collection device, and then the sample collection part is inserted into a compression tube equipped with a filter.

[0066] After that, as shown in Figures 5c and 5d, a biosensor strip having the biosensor electrode structure of the present invention is inserted into the measurement device, and then the collection device is compressed to filter or remove interfering substances from the saliva collected in the collection section and insert it into the biosensor insertion port.

[0067] At this time, the measuring device recognizes that the biosensor strip has been inserted and provides a sample recognition signal to the recognition electrode of the biosensor, and when saliva is inserted through the insertion port and recognized, provides a sample measurement signal to the reference electrode and working electrode.

[0068] When an analyte measurement signal is applied to the electrodes of the biosensor, a response signal to the analyte measurement signal is received, and a measurement result for the response signal is provided by a display means, as shown in FIG. 5e.

[0069] Here, the measurement results provided by the display means may provide results of various stages depending on the measurement value, and the numerical range and results according to salivary sugars are obvious to those skilled in the art, so detailed explanations thereof will be omitted.

[0070] Thus, the biosensor, sample measurement system, and sample measurement method according to embodiments of the present invention can improve the accuracy of measurement of substances contained in the sample by collecting a sample, for example, saliva, removing interfering substances that hinder sample measurement from the collected sample, and then measuring glucose contained in the saliva using a biosensor.

[0071] Furthermore, the biosensor, sample measurement system, and sample measurement method according to embodiments of the present invention can improve the accuracy of measuring salivary sugars by removing interfering substances that hinder salivary sugar measurement using a filter, and then measuring the saliva from which the interfering substances have been removed using a biosensor equipped with an enzyme compound.

[0072] In particular, the biosensor, sample measurement system, and sample measurement method according to the embodiments of the present invention include an enzyme in which 1 to 30 units of at least one of glucose oxidase and glucose dehydrogenase (GDH) are used in the enzyme compound, a polymer in which 0.01 to 1.0% by weight of at least one of chitosan, PVP, Nafion, polyethylene glycol, polyvinyl pyrrolidone, polyvinyl alcohol, agarose, and trehalose are used, and a catalyst in which 1 to 10% of at least one of ferrocene, ferrocene derivatives, quinone, quinone derivatives, hexaamine ruthenium (III) chloride, and ferricyanide are used (when Prussian blue is used, the catalyst may contain 0.001 to 5% Prussian blue), making it possible to measure the concentration of fine sugars as shown in FIG. 6.

[0073] The above-described devices may be implemented using hardware components, software components, and / or a combination of hardware and software components. For example, the devices and components described in the embodiments may be implemented using one or more general-purpose or special-purpose computers, such as a processor, a controller, an arithmetic logic unit (ALU), a digital signal processor, a microcomputer, a field programmable array (FPA), a programmable logic unit (PLU), a microprocessor, or various devices capable of executing and responding to instructions. The processing device may execute an operating system (OS) and one or more software applications running on the OS. The processing device may also access, record, manipulate, process, and generate data in response to the execution of the software. For ease of understanding, a single processing device may be described. However, those skilled in the art will understand that a processing device may include multiple processing elements and / or multiple types of processing elements. For example, a processing device may include multiple processors or one processor and one controller. Other processing configurations, such as parallel processors, are also possible.

[0074] Software may include computer programs, codes, instructions, or a combination of one or more of these, and may configure a processing device to operate as desired or may independently or collectively instruct the processing device. The software and / or data may be embodied in any type of machine, component, physical device, virtual device, computer storage medium, or device to be interpreted by the processing device or to provide instructions or data to the processing device. The software may be distributed and stored and executed in a distributed manner on computer systems connected by a network. The software and data may be stored on one or more computer-readable storage media.

[0075] Methods according to embodiments may be implemented in the form of program instructions executable by various computer means and recorded on a computer-readable medium. The computer-readable medium may include program instructions, data files, data structures, and the like, alone or in combination. The medium may continuously store a computer-executable program or temporarily store it for execution or download. Furthermore, the medium may be a variety of recording or storage means, including a single or multiple hardware devices, and is not limited to media directly connected to a computer system but may also be distributed over a network. Examples of media include magnetic media such as hard disks, floppy disks, and magnetic tapes; optical media such as CD-ROMs and DVDs; magneto-optical media such as floptical disks; ROM, RAM, flash memory, and the like, configured to store program instructions. Other examples of media include recording media or storage media managed by application stores, other software distribution sites, servers, and the like. Examples of program instructions include not only machine language code, such as that generated by a compiler, but also high-level language code executed by a computer using an interpreter or the like.

[0076] Although the embodiments have been described above based on limited examples and drawings, those skilled in the art will appreciate that various modifications and variations may be made from the above description. For example, the described techniques may be performed in an order different from that described, and / or the described system, structure, device, circuit, or other element may be coupled or combined in a manner different from that described, or may be substituted or replaced by other elements or equivalents, and still achieve suitable results.

[0077] Therefore, different embodiments that are equivalent to the claims are within the scope of the appended claims.

Claims

1. A biosensor for measuring salivary sugars in saliva, comprising: a working electrode and a reference electrode for measuring the salivary sugar, the working electrode including a working electrode body and one working prong, and the reference electrode including a reference electrode body and two reference prongs; at least one recognition electrode for recognizing that the saliva has flowed in through the sample insertion channel, the recognition electrode including a recognition electrode body and at least one recognition protrusion; an insulating substrate on which the working electrode, the reference electrode, and the recognition electrode are disposed; Including, the working protrusion, the reference protrusion, and the recognition protrusion at least partially form a portion for locating the saliva introduced through the specimen insertion channel; the working protrusion and the reference protrusion are spaced apart from each other along the longitudinal direction of the portion where saliva is placed, In the portion for placing saliva, the working protrusions and the reference protrusions are alternately arranged, the recognition protrusion is disposed adjacent to the working protrusion or the reference protrusion and spaced apart from the working protrusion and the reference protrusion so as to be parallel to the working protrusion and the reference protrusion; A biosensor, wherein the area of ​​the one working projection is greater than the total area of ​​the two reference projections.

2. The biosensor according to claim 1 , wherein an enzyme complex that reacts with the saliva to measure the salivary sugar is inserted into the sample insertion channel.

3. A biosensor for measuring salivary sugars in saliva, comprising: The bottom plate and a middle plate disposed on the lower plate, having a sample insertion channel formed therein, and an enzyme complex that reacts with the saliva to measure the salivary sugars inserted into the sample insertion channel; an upper plate disposed on the middle plate, the upper plate including an insertion port formed in a region corresponding to the sample insertion channel for inserting the saliva and an outlet port formed in a region different from the region corresponding to the sample insertion channel for discharging air; Including, The lower plate is a working electrode and a reference electrode for measuring the salivary sugar, the working electrode including a working electrode body and one working prong, and the reference electrode including a reference electrode body and two reference prongs; at least one recognition electrode for recognizing that the saliva has flowed in through the sample insertion channel, the recognition electrode including a recognition electrode body and at least one recognition protrusion; an insulating substrate on which the working electrode, the reference electrode, and the recognition electrode are disposed; Including, the working protrusion, the reference protrusion, and the recognition protrusion at least partially form a portion for locating the saliva introduced through the specimen insertion channel; the working protrusion and the reference protrusion are spaced apart from each other along the longitudinal direction of the portion where saliva is placed, In the portion for placing saliva, the working protrusions and the reference protrusions are alternately arranged, the recognition protrusion is disposed adjacent to the working protrusion or the reference protrusion and spaced apart from the working protrusion and the reference protrusion so as to be parallel to the working protrusion and the reference protrusion; A biosensor, wherein the area of ​​the one working projection is greater than the total area of ​​the two reference projections.

4. The biosensor according to claim 2 or 3, wherein the enzyme complex is disposed so as to extend beyond and cover both ends of the working protrusion and the reference protrusion in the longitudinal direction.

5. The biosensor of claim 2 or 3, wherein there is a portion where the working protrusion and the reference protrusion overlap with the enzyme complex in a direction perpendicular to the longitudinal direction, and in this portion, the one working protrusion and the two reference protrusions have different individual areas from each other.

6. The biosensor of any one of claims 1 to 5, wherein the working electrode body and the reference electrode body are arranged at a distance in a width direction perpendicular to the longitudinal direction, and the distance varies at least partially along the longitudinal direction.

7. The biosensor according to any one of claims 1 to 6, wherein the recognition electrode body is disposed between the working electrode body and the reference electrode body, and the recognition protrusion is disposed at the longitudinal end of the portion where the saliva is placed.

8. The biosensor electrode structure of any one of claims 1 to 7, wherein the recognition electrode performs analyte recognition in response to an analyte recognition signal applied independently of an analyte measurement signal applied to the working electrode and the reference electrode.

9. The biosensor electrode structure according to any one of claims 1 to 8, further comprising a strip recognition electrode for detecting the moment when the biosensor is inserted into a meter for measurement.

10. 1. A system for measuring salivary sugars in saliva, comprising: a collection device including a collection means for collecting the saliva and a filter for removing interfering substances in the saliva; A biosensor according to any one of claims 1 to 7, and a measurement device into which the biosensor can be inserted, the measurement device being configured to transmit an analyte recognition signal and an analyte measurement signal to the biosensor and to receive a response signal to the analyte recognition signal and a response signal to the analyte measurement signal from the biosensor. Including, the system.

Citation Information

Patent Citations

  • Redox mediators and biosensors

    JP1993505459A

  • Biochemical substrate measuring device displaying chemical dose

    JP1997068533A

  • Throw-away biosensor

    JP2001021527A

  • Biosensor and method and apparatus for quantitative determination using the same

    JP2001208715A

  • Electrochemical sensor

    JP2002055076A