Diagnostic system and control method therefor

Abstract

The present invention relates to a diagnostic system comprising: a biosensor cartridge having formed therein a flow path through which a buffer solution or a sample solution flows; a biosensor that is disposed in the biosensor cartridge and generates an electrical signal as the buffer solution or the sample solution passes; and a diagnostic device that analyzes a signal received from the biosensor. Therefore, a sensor defect may be detected by determining whether a solution is in contact with a sensor before a test is performed, sensing accuracy may be improved by detecting whether the sensor is defective before the test is performed, and reliability of measurement data may be ensured.

Description

Diagnostic system and control method

[0001] The present invention relates to a diagnostic system and a control method, and more specifically, to a diagnostic system and a control method for detecting whether a biosensor is defective before testing.

[0002] With the recent advancement of science and technology and the growing interest in the quality of life, the importance of disease diagnosis and prevention, as well as food and the environment, in human life is expanding day by day. As a result, there is an increasing need to measure the concentration of organic or inorganic substances in samples to diagnose human diseases, for specific processes in the fields of food chemistry and industrial chemistry, or to analyze pollutants in the environmental field, and many efforts are being made to address this.

[0003] A biosensor refers to a device that measures concentration by binding biomaterials, such as enzymes, microorganisms, antibodies, receptors, and DNA probes, to electrical or physicochemical transducers and detecting signals through electrochemical, optical, thermal, or piezoelectric methods based on electrode active substances or physical changes generated from reactions with the analyte to be measured.

[0004] Generally, the detection of biomaterials using biosensors is achieved through a combination of complex processes such as filtering, metering, mixing, transport, reaction, and washing. Therefore, conventionally, the detection of biomaterials is carried out manually at the laboratory level using various equipment.

[0005] Therefore, alongside the advancement of biosensor technology, the simultaneous development of fluid processing technology to automate and standardize the diagnostic process is crucial for low-cost, high-efficiency diagnosis.

[0006] Among these, equipment for detecting biomaterials requires flushing the internal flow paths before measuring each biological sample. Additionally, since large volumes of buffer solution must be stored in tanks to diagnose multiple samples, there is a risk of degradation, and there is the inconvenience of having to periodically empty the waste solution after diagnosis. Using such equipment presents limitations, as it may lead to reduced diagnostic speed and accuracy when a large volume of samples is required.

[0007] To solve this, a disposable biosensor cartridge with a built-in flow path through which buffer solution and sample solution can flow can be used. Since the disposable biosensor cartridge is used only once, a separate cleaning process is unnecessary. Additionally, since a single-use buffer solution is provided for each cartridge, there is no possibility of the buffer solution deteriorating, and the waste solution is emptied along with the cartridge when it is discarded.

[0008] In this regard, Korean published patent KR 10-2022-0047600A discloses a point-of-care molecular diagnostic system.

[0009] In the case of a conventional optical measurement diagnostic system that flows a solution through a sensor and measures reflected light, there is a problem in that the sensing accuracy is reduced and the reliability of the measurement data is lowered because the test is conducted without detecting sensor defects caused by the solution not contacting the sensor due to bubbles, etc.

[0010] The present invention was created to improve upon the problems described above, and aims to provide a diagnostic system and a control method capable of detecting sensor defects by determining whether a solution contacts the sensor before proceeding with a test.

[0011] In addition, the purpose is to provide a diagnostic system and a control method that can improve sensing accuracy and ensure the reliability of measurement data through the detection of sensor defects and flow rate correction processes prior to testing.

[0012] In addition, the purpose is to provide a diagnostic system and a control method that can reduce the time required until the start of a test by setting the flow rate of the solution to a high speed when determining whether the solution contacts the sensor before the test is conducted.

[0013] To achieve the above-mentioned purpose, the diagnostic system according to the present invention comprises a biosensor cartridge having a flow path formed therein through which a buffer solution or a sample solution flows, a biosensor disposed in the biosensor cartridge and generating an electrical signal as the buffer solution or the sample solution passes through, and a diagnostic device for analyzing a signal received from the biosensor. The diagnostic device sets the flow rate of the buffer solution to a preset first reference flow rate and determines whether the buffer solution is in normal contact with the biosensor. If it is determined that the buffer solution is in normal contact with the biosensor, the flow rate of the sample solution can be set to a second reference flow rate lower than the first reference flow rate.

[0014] The biosensor may include a substrate, a gate formed on the substrate and in contact with the buffer solution or the sample solution, a first drain formed on the substrate, a first source formed on the substrate, a second drain formed on the substrate, a second source formed on the substrate, a first drain source channel formed between the first drain and the first source and formed on one side of the gate, and a second drain source channel formed between the second drain and the second source and formed on one side of the first drain source channel.

[0015] The diagnostic device can determine whether the buffer solution is in normal contact with the biosensor based on the result of comparing the first transconductance of the first drain source channel and the second transconductance of the second drain source channel with the preset reference transconductance after setting the flow rate of the buffer solution to a preset first reference flow rate.

[0016] When the diagnostic device determines that the buffer solution is in normal contact with the biosensor, it can calculate a measured flow rate value and correct the flow rate of the buffer solution based on the result of comparing the measured flow rate value with the first reference flow rate.

[0017] The diagnostic device can calculate the actual flow rate value based on the time interval between the first time point when the first transconductance is determined to be normal and the second time point when the second transconductance is determined to be normal, and the distance between the first drain source channel and the second drain source channel.

[0018] The diagnostic device measures a first transfer curve of the first drain source channel based on the gate voltage and the first drain current, measures a second transfer curve of the second drain source channel based on the gate voltage and the second drain current, and can determine whether the buffer solution is in normal contact with the biosensor based on the first transfer curve and the second transfer curve.

[0019] The diagnostic device may determine that the buffer solution is abnormally in contact with the biosensor if the first transfer curve or the second transfer curve is not measured.

[0020] The diagnostic device can determine whether the first transconductance and the second transconductance are normal transconductances based on the result of comparing the first transconductance of the first drain source channel and the second transconductance of the second drain source channel with a preset reference transconductance after setting the flow rate of the sample solution to the second reference flow rate which is lower than the first reference flow rate.

[0021] The diagnostic device may determine that the biosensor is defective if the first transconductance and the second transconductance are not normal transconductances.

[0022] To achieve the above-mentioned purpose, a control method for a diagnostic device coupled with a biosensor cartridge including a biosensor according to the present invention may include the steps of: setting the flow rate of a buffer solution to a preset first reference flow rate; determining whether the buffer solution is in normal contact with the biosensor; and, if it is determined that the buffer solution is in normal contact with the biosensor, setting the flow rate of a sample solution to a second reference flow rate lower than the first reference flow rate.

[0023] The biosensor comprises a substrate, a gate formed on the substrate and in contact with the buffer solution or the sample solution, a first drain formed on the substrate, a first source formed on the substrate, a second drain formed on the substrate, a second source formed on the substrate, a first drain source channel formed between the first drain and the first source and formed on one side of the gate, and a second drain source channel formed between the second drain and the second source and formed on one side of the first drain source channel, and the step of determining whether the buffer solution is in normal contact with the biosensor may include the step of determining whether the buffer solution is in normal contact with the biosensor based on the result of comparing the first transconductance of the first drain source channel and the second transconductance of the second drain source channel with a preset reference transconductance.

[0024] The step of determining whether the buffer solution is in normal contact with the biosensor may further include the step of calculating a measured flow rate value and correcting the flow rate of the buffer solution based on the result of comparing the measured flow rate value with the first reference flow rate when it is determined that the buffer solution is in normal contact with the biosensor.

[0025] The step of calculating the actual flow rate value and correcting the flow rate of the buffer solution based on the result of comparing the actual flow rate value with the first reference flow rate can calculate the actual flow rate value based on the time interval between the first time point when the first transconductance matches the reference transconductance and the second time point when the second transconductance matches the reference transconductance, and the distance between the first drain source channel and the second drain source channel.

[0026] The step of determining whether the buffer solution is in normal contact with the biosensor may include measuring a first transfer curve of the first drain source channel based on a gate voltage and a first drain current, measuring a second transfer curve of the second drain source channel based on the gate voltage and a second drain current, and determining whether the buffer solution is in normal contact with the biosensor based on the first transfer curve and the second transfer curve.

[0027] The step of determining whether the buffer solution is in normal contact with the biosensor may further include the step of determining that the buffer solution is in abnormal contact with the biosensor if the first transfer curve or the second transfer curve is not measured.

[0028] After the step of setting a second reference flow rate lower than the first reference flow rate, the method may further include a step of determining whether the first transconductance and the second transconductance are normal transconductances based on the result of comparing the first transconductance and the second transconductance with a preset reference transconductance.

[0029] After the step of determining whether the first transconductance and the second transconductance are normal transconductances, the method may further include a step of determining that the biosensor is defective if the first transconductance and the second transconductance are not normal transconductances.

[0030] By setting the solution flow rate to high speed when determining whether the solution is in contact with the sensor before proceeding with the test, the time required to start the test can be shortened.

[0031] Sensor defects can be detected by determining whether the solution contacts the sensor before proceeding with the test.

[0032] Sensing accuracy can be improved and the reliability of measurement data can be ensured through the process of detecting sensor defects and correcting flow rates before conducting the test.

[0033] FIG. 1 is a drawing for explaining a biosensor cartridge and a diagnostic device according to one embodiment of the present invention.

[0034] FIGS. 2 and FIGS. 3 are drawings for explaining a biosensor cartridge according to an embodiment of the present invention.

[0035] Figure 4 is a plan view illustrating the state with the upper housing removed.

[0036] FIG. 5 is an exploded perspective view for explaining a frame according to one embodiment of the present invention.

[0037] FIG. 6 is a plan view for explaining a top frame according to one embodiment of the present invention.

[0038] FIG. 7 is a bottom view illustrating a channel formed in a top frame according to one embodiment of the present invention.

[0039] FIG. 8 is a diagram illustrating the combination of a biosensor and a printed circuit board to a frame in a biosensor cartridge according to one embodiment of the present invention.

[0040] FIGS. 9 and 10 are cross-sectional views illustrating the arrangement of a biosensor and a printed circuit board and the arrangement of a flow path flowing over the biosensor in a biosensor cartridge according to an embodiment of the present invention.

[0041] FIG. 11 is a perspective view illustrating the internal configuration of a diagnostic device according to one embodiment of the present invention.

[0042] FIG. 12 is a diagram illustrating the flow of a sample solution in the prefill step of a biosensor cartridge and diagnostic device according to one embodiment of the present invention.

[0043] FIG. 13 is a diagram illustrating the rotation of a valve part in the buffer solution circulation step of a biosensor cartridge and diagnostic device according to one embodiment of the present invention.

[0044] FIG. 14 is a diagram illustrating the flow of a buffer solution in the buffer solution circulation step of a biosensor cartridge and diagnostic device according to one embodiment of the present invention.

[0045] FIG. 15 is a diagram illustrating the rotation of a valve part in the sample solution circulation step of a biosensor cartridge and diagnostic device according to one embodiment of the present invention.

[0046] FIG. 16 is a diagram illustrating the flow of a sample solution in the sample solution circulation step of a biosensor cartridge and diagnostic device according to one embodiment of the present invention.

[0047] FIG. 17 is a block diagram of a biosensor cartridge and a diagnostic device according to one embodiment of the present invention.

[0048] FIG. 18 is a diagram illustrating the structure of a biosensor according to one embodiment of the present invention.

[0049] FIG. 19 is a cross-sectional view in the AA' direction of a biosensor according to one embodiment of the present invention.

[0050] FIGS. 20 and 21 are drawings for explaining the operation method of a diagnostic device according to an embodiment of the present invention.

[0051] Figures 22 and 23 are drawings for explaining a transfer curve.

[0052] FIGS. 24 to 26 are drawings for explaining examples of abnormalities in a biosensor.

[0053] Figure 27 is a diagram illustrating the actual flow rate of the biosensor.

[0054] Preferred embodiments of the present invention will be described in detail below with reference to the attached drawings.

[0055] The present invention is capable of various modifications and may have various embodiments, and specific embodiments are illustrated in the drawings and described in detail in the detailed description. This is not intended to limit the present invention to specific embodiments, and should be interpreted to include all modifications, equivalents, and substitutions that fall within the spirit and scope of the invention.

[0056] In describing the present invention, terms such as "first," "second," etc., may be used to describe various components, but said components may not be limited by said terms. Such terms are used solely for the purpose of distinguishing one component from another. For example, without departing from the scope of the present invention, the first component may be named the second component, and similarly, the second component may be named the first component.

[0057] The term "and / or" may include a combination of multiple related listed items or any of the multiple related listed items.

[0058] When it is stated that one component is "connected" or "connected" to another component, it can be understood that while it may be directly connected or connected to that other component, there may also be other components in between. On the other hand, when it is stated that one component is "directly connected" or "directly connected" to another component, it can be understood that there are no other components in between.

[0059] The terms used in this application are used merely to describe specific embodiments and are not intended to limit the invention. Singular expressions may include plural expressions unless the context clearly indicates otherwise.

[0060] In this application, terms such as “comprising” or “having” are intended to indicate the existence of the features, numbers, steps, actions, components, parts, or combinations thereof described in the specification, and should be understood as not excluding in advance the existence or addition of one or more other features, numbers, steps, actions, components, parts, or combinations thereof.

[0061] Unless otherwise defined, all terms used herein, including technical or scientific terms, may have the same meaning as generally understood by those skilled in the art to which the present invention pertains. Terms such as those defined in commonly used dictionaries may be interpreted as having a meaning consistent with their meaning in the context of the relevant technology, and may not be interpreted in an ideal or overly formal sense unless explicitly defined in this application.

[0062] In addition, the following embodiments are provided to explain more completely to those with average knowledge in the industry, and the shapes and sizes of the elements in the drawings may be exaggerated for clearer explanation.

[0063]

[0064] FIG. 1 is a drawing for explaining a biosensor cartridge and a diagnostic device according to an embodiment of the present invention. FIG. 2 and FIG. 3 are drawings for explaining a biosensor cartridge according to an embodiment of the present invention. FIG. 4 is a plan view for explaining the state with the upper housing removed.

[0065] Referring to FIGS. 1 to 4, a biosensor cartridge (1) according to one embodiment of the present invention is coupled to a diagnostic device (2) to detect biomaterials and thereby diagnose diseases, etc. In one embodiment, the biosensor cartridge (1) may be inserted into the diagnostic device (2) in a state arranged along a horizontal direction. The biosensor cartridge (1) may allow buffer solution and sample solution to flow inside, thereby causing the biosensor (400) to undergo an electrochemical reaction with biomaterials, and may transmit the resulting electrical change to the diagnostic device (2) through a printed circuit board (500).

[0066] A biosensor cartridge (1) according to one embodiment of the present invention may include a housing (100), a frame (200), a tank (300), a biosensor (400), a printed circuit board (500), a channel (600), a tube (700), a valve section (800), and a pump section (900).

[0067] A frame (200) is accommodated inside the housing (100), a tank (300) is formed on the upper side of the frame (200), and a channel (600) may be formed inside the frame (200). A tube (700), a valve section (800), and a pump section (900) are coupled to the frame (200), and a biosensor (400) and a printed circuit board (500) may be detachably coupled.

[0068] In the present invention, the direction in which the buffer solution is introduced relative to the frame (200) can be called the upper side, the direction opposite to the upper side relative to the frame (200) can be called the lower side, and the direction in which the biosensor cartridge (1) is inserted into the diagnostic device (2) can be called the front. That is, the direction in which the printed circuit board (500) is placed relative to the housing (100) can be called the front. Also, the direction opposite to the front can be called the rear. Additionally, when looking at the front from the rear end of the housing (100), the direction placed on the left can be called the left, and the direction placed on the right can be called the right.

[0069] The housing (100) forms the outer shape of the biosensor cartridge (1) and can accommodate a frame (200), a tank (300), a biosensor (400), a printed circuit board (500), a channel (600), a tube (700), a valve section (800), and a pump section (900) inside.

[0070] The housing (100) may include an upper housing (110) and a lower housing (120).

[0071] In one embodiment, the upper housing (110) is formed in the shape of a square box with the lower side open, and a buffer solution inlet hole (111), a sample solution inlet hole (112), a valve connection hole (113), and a pump connection hole (114) may be formed on the upper side.

[0072] The buffer solution inlet hole (111) can be formed to allow the buffer solution to flow in. The buffer solution inlet hole (111) can be formed in the blister receiving groove (111a).

[0073] A buffer blister (3) can be coupled to the blister receiving groove (111a). With this configuration, the buffer blister (3) can burst while being received inside the blister receiving groove (111a), allowing the buffer solution to pass through the buffer solution inlet hole (111) and flow into the buffer solution tank (310).

[0074] At least one ventilation hole (111b, 116) may be formed on the upper surface of the upper housing (110). This prevents the air pressure inside the buffer solution tank (310) from rising and reduces the probability of air mixing with the buffer solution.

[0075] A first ventilation channel (111c) may be further formed on the upper surface of the upper housing (110). The first ventilation channel (111c) is formed to communicate with the first ventilation hole (111b) and may be formed in a groove shape along the upper surface of the upper housing (110).

[0076] The sample solution inlet hole (112) can be formed to allow the sample solution to flow in.

[0077] The valve connection hole (113) can be formed so that a part of the valve part (800) passes through it.

[0078] The pump connection hole (114) can be formed so that a part of the pump section (900) passes through it.

[0079] A second ventilation hole (116) may be further formed on the upper surface of the upper housing (110). The second ventilation hole (116) may be positioned vertically above the waste solution tank (330). This prevents the air pressure inside the waste solution tank (330) from rising.

[0080] A second ventilation channel (116a) may be further formed on the upper surface of the upper housing (110). The second ventilation channel (116a) is formed to communicate with the second ventilation hole (116) and may be formed in a groove shape along the upper surface of the upper housing (110). Through this configuration, when a label (130) is attached to the upper surface of the upper housing (110), the second ventilation channel (116a) forms a space between the upper housing (110) and the label (130) to accommodate air discharged through the second ventilation hole (116).

[0081] The lower housing (120) can be combined with the upper housing (110) to form a space that accommodates a frame (200), a tank (300), a biosensor (400), a printed circuit board (500), a channel (600), a tube (700), a valve section (800), and a pump section (900) inside.

[0082] A sensor insertion hole (121) into which a biosensor (400) can be inserted may be formed on the lower side of the lower housing (120).

[0083] A sensor cover (122) can be attached to the lower side of the lower housing (120).

[0084] The sensor cover (122) may include a hook (122a), a sensor support (122b), and a coupling guide (not shown).

[0085]

[0086] FIG. 5 is an exploded perspective view for explaining a frame according to one embodiment of the present invention. FIG. 6 is a plan view for explaining a top frame according to one embodiment of the present invention.

[0087] Referring to FIGS. 5 and 6, the frame (200) is placed inside the housing (100) and can form a channel (600) through which a buffer solution and a sample solution flow.

[0088] A biosensor (400) and a printed circuit board (500) are detachably coupled to the frame (200) so that the biosensor (400) can detect biomaterials in a sample solution flowing through a channel (600).

[0089] The frame (200) may include a base frame (210), a top frame (220), a hydrophilic adhesive layer (230), and a microchannel forming adhesive layer (240).

[0090] The base frame (210) can be detachably coupled to the biosensor (400).

[0091] The sensor coupling portion (211) can be detachably coupled to the biosensor (400).

[0092] A biosensor (400) can be fitted and coupled to the sensor coupling part (211).

[0093] A hole may be formed in the base frame (210) to fix the valve part (800) and the pump part (900), and a fixing member such as a screw may pass through the hole and be coupled with the valve part (800) and the pump part (900) positioned on the upper side of the top frame (220).

[0094] A tank (300) may be formed on the top frame (220). In one embodiment, a tank (300) may be formed on the upper surface of the top frame (220).

[0095] A channel (600) may be formed in the top frame (220). In one embodiment, a channel (600) may be formed on the lower surface of the top frame (220).

[0096] A substrate coupling portion (221) may be formed on the upper surface of the top frame (220). A printed circuit board (500) may be detachably coupled to the substrate coupling portion (221). The substrate coupling portion (221) may be positioned facing the sensor coupling portion (211).

[0097] The substrate coupling portion (221) may include a coupling guide portion (221a) that guides the slide coupling of the printed circuit board (500).

[0098] The substrate coupling portion (221) may further include a substrate support portion (221b) that guides the coupling position of the printed circuit board (500) and supports the printed circuit board (500). A pair of substrate support portions (221b) may be formed protruding upward from the upper surface of the top frame (220).

[0099] A clip receiving hole (221c) for receiving a contact clip (450) may be formed in the substrate coupling portion (221).

[0100] A pair of clip receiving holes (221c) can be formed to communicate with the sensor coupling part (211).

[0101] A tube receiving portion (222) may be formed in the top frame (220). The tube receiving portion (222) may be formed to protrude upward from the upper surface of the top frame (220).

[0102] The tube receiving portion (222) is formed to protrude in a block shape from the upper surface of the top frame (220), and a pump receiving groove (222a) and a tube guide groove (222b) may be formed inside.

[0103] The pump receiving groove (222a) can accommodate at least a portion of the tube (700) and the pump part (900) inside.

[0104] The tube guide groove (222b) is formed to communicate with the pump receiving groove (222a) and can accommodate at least a portion of the tube (700).

[0105] A valve coupling portion (223) may be formed on the top frame (220).

[0106] A buffer solution inlet port (315), a buffer solution port (615), a sample solution port (625), a sensing port (635), a prefill port (645), a waste solution port (655), a first tube connection port (660), and a second tube connection port (670) may be formed in the top frame (220).

[0107] The buffer solution port (615), sample solution port (625), sensing port (635) and prefill port (645) can be arranged to be connected by the valve section (800).

[0108] The first tube connection port (660) and the second tube connection port (670) may be provided to be connected to the tube (700).

[0109] The tank (300) is formed on the upper side of the frame (200) and can provide a space in which a buffer solution and / or a sample solution can be received.

[0110] The tank (300) may include a buffer solution tank (310).

[0111] A buffer solution inlet port (315) may be formed in the top frame (220), and the buffer solution inlet port (315) may be formed to communicate with the buffer solution channel (610).

[0112] The tank (300) may include a sample solution tank (320).

[0113] The tank (300) may include a waste solution tank (330).

[0114]

[0115] FIG. 7 is a bottom view illustrating a channel formed in a top frame according to one embodiment of the present invention.

[0116] Referring to FIGS. 6 and 7, the channel (600) is formed inside the frame (200) and can provide a flow path through which a buffer solution or sample solution can flow. The channel (600) can be formed on the lower side of the top frame (220).

[0117] The channel (600) may include a buffer solution channel (610) through which the buffer solution flows, and which is connected to the buffer solution tank (310). One side of the buffer solution channel (610) may be in communication with the buffer solution inlet port (315). One side of the buffer solution channel (610) may be in communication with the internal space of the buffer solution tank (310) through the buffer solution inlet port (315). The other side of the buffer solution channel (610) may be in communication with the buffer solution port (615). The other side of the buffer solution channel (610) may be in communication with the sensing channel (630) through the buffer solution port (615) according to the operation of the valve section (800).

[0118] The buffer solution channel (610) can guide the buffer solution flowing into the buffer solution tank (310) to the valve section (800).

[0119] The buffer solution inlet port (315) can serve as an inlet for the buffer solution channel (610), and the buffer solution port (615) can serve as an outlet for the buffer solution channel (610).

[0120] The channel (600) may include a sample solution channel (620) through which the sample solution flows, which is connected to the sample solution tank (320). One side of the sample solution channel (620) may be in communication with the internal space of the sample solution tank (320). The other side of the sample solution channel (620) may be in communication with the sample solution port (625). The other side of the sample solution channel (620) may be in communication with the sensing channel (630) through the sample solution port (625) according to the operation of the valve part (800).

[0121] The sample solution channel (620) can guide the sample solution flowing into the sample solution tank (320) to the valve section (800).

[0122] The channel (600) may include a sensing channel (630) that is connected to a buffer solution channel (610) or a sample solution channel (620) and guides the buffer solution or sample solution to the biosensor (400).

[0123] One side of the sensing channel (630) may be in communication with the sensing port (635). The other side of the sensing channel (630) may be in communication with the first tube connection port (660). The other side of the sensing channel (630) may be in communication with a flow path formed inside the tube (700) through the first tube connection port (660) according to the operation of the valve part (800).

[0124] The sensing channel (630) can guide the buffer solution or sample solution introduced through the valve section (800) to the biosensor (400) and allow it to pass through the biosensor (400).

[0125] The sensing channel (630) may include a first sensing channel (631) and a second sensing channel (632).

[0126] The first sensing channel (631) can guide the buffer solution or sample solution that has passed through the valve section (800) to the biosensor (400).

[0127] The buffer solution or sample solution that has passed through the first sensing channel (631) can flow on the upper surface of the biosensor (400).

[0128] The sensing port (635) can serve as an inlet for the first sensing channel (631), and the sensor coupling part (211) can serve as an outlet for the first sensing channel (631).

[0129] The second sensing channel (632) can guide the buffer solution or sample solution that has passed through the biosensor (400) into the tube (700). In one embodiment, the second sensing channel (632) may be in communication with the discharge port (632a) formed in the base frame (210) and may be formed along the left and right directions to be in communication with the first tube connection port (660). The second sensing channel (632) may be positioned in a straight line downstream of the first sensing channel (631).

[0130] The channel (600) may include a prefill channel (640) through which the sample solution flows, which is in communication with the sample solution channel (620). One side of the prefill channel (640) may be in communication with the sample solution channel (620). One side of the prefill channel (640) may be in communication with the sample solution port (625). The other side of the prefill channel (640) may be in communication with the prefill port (645).

[0131] The prefill channel (640) can guide the sample solution that has passed through the sample solution channel (620) to the prefill port (645).

[0132] The channel (600) may include a waste solution channel (650) that guides the buffer solution or sample solution that has passed through the tube (700) to a waste solution tank (330).

[0133]

[0134] FIG. 8 is a diagram illustrating the combination of a biosensor and a printed circuit board with respect to a frame in a biosensor cartridge according to an embodiment of the present invention. FIG. 9 and FIG. 10 are cross-sectional views illustrating the arrangement of a biosensor and a printed circuit board and the arrangement of a flow path flowing over the biosensor in a biosensor cartridge according to an embodiment of the present invention.

[0135] Referring to FIGS. 8 to 10, the biosensor (400) is detachably coupled to the frame (200) and can detect biomaterials. The biosensor (400) can be inserted through the sensor insertion hole (121) of the lower housing (120), and the biosensor (400) can be coupled to the sensor coupling part (211) of the base frame (210).

[0136] A biosensor (400) can selectively detect a minute amount of biomaterial to be analyzed by combining a bioreceptor having a recognition function for a specific biomaterial with an electrical transducer to convert biological interactions and recognition responses into electrical signals.

[0137] In one embodiment, a sensing portion may be provided on the upper surface of the biosensor (400). A bio-receptor may be disposed in the sensing portion. A buffer solution and a sample solution may flow through the sensing portion. The sensing portion may be connected to a circuit to transmit an electrical signal generated in the sensing portion.

[0138] A circuit may be placed on the biosensor (400) and may be electrically connected to the printed circuit board (500) by a contact clip (450).

[0139] A sealer (410) may be disposed on the upper side of the biosensor (400). The sealer (410) may be disposed on the sensor coupling portion (211). A flow path forming portion (411) may be formed in the sealer (410). In one embodiment, the sealer (410) may be formed in the shape of a rectangular parallelepiped, and the flow path forming portion (411) may be in the shape of a slit formed along the left and right directions.

[0140] The flow path forming part (411) may be positioned on the lower side of the frame formed in the sensor coupling part (211). The flow path forming part (411) may be positioned on the lower side of the inlet port (631a) and the outlet port (632a) formed in the sensor coupling part (211), and may be in communication with the inlet port (631a) and the outlet port (632a). The buffer solution and sample solution flowing through the first sensing channel (631) may flow through the flow path inside the flow path forming part (411) via the inlet port (631a), pass through the outlet port (632a), and be introduced into the second sensing channel (632).

[0141] The flow path forming part (411) may be positioned above the sensing part of the biosensor (400). The sealer (410) may be formed to surround the outer edge of the sensing part. The sealer (410) seals the outer edge of the flow path forming part (411) to prevent the buffer solution and sample solution flowing inside the flow path forming part (411) from leaking out.

[0142] The printed circuit board (500) can be detachably coupled to the frame (200). At least a portion of the biosensor (400) can be inserted into the upper housing (110) and detachably coupled to the substrate coupling portion (221) of the top frame (220). The printed circuit board (500) can be supported by the coupling guide portion (221a) and the substrate support portion (221b).

[0143] The printed circuit board (500) may include a board body (510), a connector (520), and a guide portion (530). In one embodiment, the board body (510) may be formed in the shape of a roughly rectangular flat plate. A circuit may be mounted on the board body (510) and electrically connected to the biosensor (400).

[0144] A connector (520) may be provided at the front end of the substrate body (510). The connector (520) may be connected to a circuit provided in the substrate body (510). When the biosensor cartridge (1) is coupled to the diagnostic device (2), an electrical signal can be transmitted to the diagnostic device (2) through the connector (520). When the biosensor cartridge (1) is coupled to the diagnostic device (2), power can be applied to the printed circuit board (500) and the biosensor (400) through the connector (520).

[0145] The guide portion (530) may be formed at both ends of the substrate body (510) in the left and right directions and may be coupled with the substrate support portion (221b) of the substrate coupling portion (221). In one embodiment, the guide portion (530) may be formed as a recessed shape in the left and right directions of the substrate body (510). Through this, it may be coupled with the protruding shape of the substrate support portion (221b) to guide the accurate coupling position of the printed circuit board (500) and stably support the printed circuit board (500) in the coupled state.

[0146] A contact clip (450) may be placed between the biosensor (400) and the printed circuit board (500). The contact clip (450) is coupled to the sensor coupling portion (211) and may come into contact with the printed circuit board (500) and the biosensor (400). The contact clip (450) is positioned to pass through the clip receiving hole (221c) and to pass through the hole of the sensor coupling portion (211), but at least a portion may be supported by the base frame (210).

[0147] A plurality of contact clips (450) may be provided. An even number of contact clips (450) may be provided. A plurality of pairs of contact clips (450) may be arranged side by side, and one pair may be symmetrically arranged in a position facing each other. In one embodiment, six contact clips (450) may be provided, and three pairs may be arranged side by side, and each pair may be symmetrically arranged in a position facing each other.

[0148] The contact clip (450) may be formed of a conductive material. In one embodiment, the contact clip (450) may be formed of a metal material. Each contact clip (450) may include a substrate contact portion (451), a sensor contact portion (452), and a connection portion (453).

[0149] The sensor contact portion (452) is positioned to pass through a hole formed in the sensor coupling portion (211) and can come into contact with a terminal (not shown) provided in the biosensor (400). That is, the sensor contact portion (452) can be electrically connected to a circuit mounted on the biosensor (400). In one embodiment, the sensor contact portion (452) may be in the form of a plate that is formed extending downward from the coupling portion (453), then folded and extended upward.

[0150] The total height of the contact clip (450) in the vertical direction can be formed to be longer than the shortest distance between the biosensor (400) and the printed circuit board (500). Through this, when the sensor contact portion (452) comes into contact with the biosensor (400), the sensor contact portion (452) can apply pressure to the biosensor (400) while elastically deforming, and can maintain a strong contact state while minimizing the contact area with the biosensor (400).

[0151] The connecting portion (453) may be formed to connect the substrate contact portion (451) and the sensor contact portion (452). The connecting portion (453) is formed by bending and extending downward from the substrate contact portion (451), then being bent and extended along the front-rear direction, and may be connected to the sensor contact portion (452) by bending and extending downward. The connecting portion (453) may be supported by contacting the base frame (210).

[0152] The contact clip (450) is seated on the frame (200), so that its upper side contacts the printed circuit board and its lower side contacts the biosensor (400). Through the contact clip (450), the buffer solution and sample solution can be flowed between the printed circuit board (500) and the biosensor (400), while the electrical signal generated from the biosensor (400) can be transmitted to the printed circuit board over the shortest distance.

[0153]

[0154] FIG. 11 is a perspective view illustrating the internal configuration of a diagnostic device according to an embodiment of the present invention. FIG. 12 is a diagram illustrating the flow of a sample solution during the prefill stage in a biosensor cartridge and diagnostic device according to an embodiment of the present invention. FIG. 13 is a diagram illustrating the rotation of a valve part during the buffer solution circulation stage in a biosensor cartridge and diagnostic device according to an embodiment of the present invention. FIG. 14 is a diagram illustrating the flow of a buffer solution during the buffer solution circulation stage in a biosensor cartridge and diagnostic device according to an embodiment of the present invention. FIG. 15 is a diagram illustrating the rotation of a valve part during the sample solution circulation stage in a biosensor cartridge and diagnostic device according to an embodiment of the present invention. FIG. 16 is a diagram illustrating the flow of a sample solution during the sample solution circulation stage in a biosensor cartridge and diagnostic device according to an embodiment of the present invention.

[0155] Referring to FIGS. 1 and 2, the biosensor cartridge (1) may have a biosensor (400) and a printed circuit board (500) combined therein. However, if there is an error in the biosensor (400) and the printed circuit board (500), the user may replace them.

[0156] The user can inject the buffer solution into the biosensor cartridge (1). The user can inject it into the buffer solution injection hole (111). In the present invention, the buffer solution can be injected into the buffer solution injection hole (111) using a buffer blister (3).

[0157] The buffer solution that has passed through the buffer solution inlet hole (111) can be contained in the buffer solution tank (310). It can then flow into the buffer solution inlet port (315) along the inclined surface (311). Additionally, some of the buffer solution contained in the buffer solution tank (310) can flow along the buffer solution channel (610). However, unless the pump unit (900) is operating, it may not flow into the sensing channel (630).

[0158] The user can inject the sample solution into the sample solution inlet hole (112). The user can inject the sample solution into the sample solution inlet hole (112) using a sample injection tool (not shown) including a dropper.

[0159] It is possible to inject the buffer solution and the sample solution simultaneously, to inject the sample solution first and then the buffer solution, or to inject the buffer solution first and then the sample solution.

[0160] The sample solution that has passed through the sample solution inlet hole (112) can be received in the sample solution tank (320). And, some of the sample solution received in the sample solution tank (320) can flow along the sample solution channel (620). However, unless the pump unit (900) is operated, it may not flow into the sensing channel (630).

[0161] After the buffer solution and sample solution are introduced, the user can insert the biosensor cartridge (1) into the diagnostic device (2).

[0162] Referring to FIGS. 11 to 16, before the biosensor cartridge (1) is inserted into the diagnostic device (2), the diagnostic device control unit (26) can check whether the actuator shafts (24a, 25a) of the valve actuator (24) and the pump actuator (25) are aligned in their original positions.

[0163] When the biosensor cartridge (1) is inserted into the diagnostic device (2), the printed circuit board (500) can be electrically connected to a terminal built into the diagnostic device (2). Power is applied to the printed circuit board (500), and the diagnostic device control unit (26) can detect that the biosensor cartridge (1) is connected.

[0164] When the biosensor cartridge (1) is detected to be inserted into the diagnostic device (2), the diagnostic device control unit (26) can operate the loading actuator (23b).

[0165] Afterwards, the diagnostic device control unit (26) can perform a prefill step.

[0166] In the prefill stage, the diagnostic device control unit (26) can operate the valve actuator (24) to connect the prefill port (645) and the sensing port (635). The diagnostic device control unit (26) can control the valve actuator (24) so ​​that the connection channel (833) is positioned at a preset first position.

[0167] The diagnostic device control unit (26) can operate the pump actuator (25) while the prefill port (645) and the sensing port (635) are connected. The diagnostic device control unit (26) can operate the pump actuator (25) for a preset time. Accordingly, the sample solution contained in the sample solution tank (320) can flow into the prefill channel (640) after passing through the sample solution channel (620). Through this, the sample solution can be made to completely fill the sample solution channel (620), and air bubbles can be removed through the prefill channel (640).

[0168] Afterwards, the diagnostic device control unit (26) can perform a buffer solution circulation step.

[0169] In the buffer solution circulation step, the diagnostic device control unit (26) can operate the valve actuator (24) to connect the buffer solution port (615) and the sensing port (635). The diagnostic device control unit (26) can control the valve actuator (24) so ​​that the connection channel (833) is positioned at a preset second position.

[0170] The diagnostic device control unit (26) can operate the pump actuator (25) while the buffer solution port (615) and the sensing port (635) are connected. The diagnostic device control unit (26) can operate the pump actuator (25) for a preset time. Accordingly, the buffer solution contained in the buffer solution tank (310) can flow through the sensing channel (630) after passing through the buffer solution channel (610). At this time, power can be applied to the printed circuit board (500) and the biosensor (400). The diagnostic device control unit (26) can detect the electrical signal received through the printed circuit board (500).

[0171] Afterwards, the diagnostic device control unit (26) can perform a sample solution circulation step.

[0172] In the sample solution circulation step, the diagnostic device control unit (26) can operate the valve actuator (24) to connect the sample solution port (625) and the sensing port (635). At this time, the diagnostic device control unit (26) can control the valve actuator (24) so ​​that the connection channel (833) is positioned at a preset third position.

[0173] The diagnostic device control unit (26) can operate the pump actuator (25) while the sample solution port (625) and the sensing port (635) are connected. At this time, the diagnostic device control unit (26) can operate the pump actuator (25) for a preset time. Accordingly, the buffer solution contained in the sample solution tank (320) can flow through the sensing channel (630) after passing through the sample solution channel (620). At this time, power can be applied to the printed circuit board (500) and the biosensor (400). Also, the diagnostic device control unit (26) can detect the electrical signal received through the printed circuit board (500). The diagnostic device control unit (26) can determine the presence of biomaterial by comparing the electrical signal value in the buffer solution circulation stage with the electrical signal value in the sample solution circulation stage.

[0174] Afterwards, the diagnostic device control unit (26) can indicate whether there is a biomaterial through the display (21b).

[0175]

[0176] FIG. 17 is a block diagram of a diagnostic system including a biosensor cartridge (1), a biosensor (400), and a diagnostic device (2) according to one embodiment of the present invention.

[0177] Referring to FIG. 17, the diagnostic device (2) may further include a sensor control unit (27), a signal conversion amplifier (28a), a signal regulator (28b), a signal processor (28c), and a battery (29).

[0178] The sensor control unit (27) can control the operation of the biosensor (400). The signal conversion amplifier (28a) can convert and amplify the signal generated from the biosensor (400) so that minute changes in the biosensor (400) can be read. The signal regulator (28b) can remove noise from the signal generated from the biosensor (400). The signal processor (28c) can perform preprocessing on the signal generated from the biosensor (400) before the diagnostic device control unit (26) analyzes the signal. The battery (29) can supply power to each component of the diagnostic device (2).

[0179] FIG. 18 is a diagram illustrating the structure of a biosensor according to one embodiment of the present invention. FIG. 19 is a cross-sectional view in the AA' direction of a biosensor according to one embodiment of the present invention.

[0180] Referring to FIGS. 18 and 19, a biosensor (400) according to one embodiment of the present invention may include a substrate (401), a gate (420), a first drain (431), a first source (432), a first drain source channel (433), a second drain (441), a second source (442), and a second drain source channel (443).

[0181] As one embodiment, the substrate (401) may be in a single crystal state and may include silicon (Si) material. As one embodiment, the substrate (401) may be a thinned substrate through a thinning process.

[0182] A gate (420) is formed on a substrate (401) and may be in contact with a buffer solution or sample solution, which is a fluid (L). The gate (420) serves as a common gate electrode and performs the function of applying an intended voltage to the solution in contact with the first drain source channel (433) and the second drain source channel (443).

[0183] The gate (420) can be positioned or formed at a lower position of the inlet port (631a) formed in the base frame (210) of the biosensor cartridge (1) when coupled to the biosensor cartridge (1).

[0184] The gate (420) may include polysilicon or a metallic material (e.g., tungsten (W), copper (Cu), aluminum (Al), gold (Au), palladium (Pd)).

[0185] The gate (420) can be formed by a photolithography method, patterning, or a deposition process such as CVD.

[0186] The first drain (431) may be formed on the substrate (401). The first drain (431) may be placed or formed on one side of the gate (420).

[0187] The first source (432) may be formed on the substrate (401). The first source (432) may be placed or formed on the other side of the gate (420).

[0188] The first drain source channel (433) is a first graphene channel (Ch1) through which the fluid (L) passes first, is formed between the first drain (431) and the first source (432), and can be formed on one side of the gate (420).

[0189] The second drain (441) may be formed on the substrate (401). The second drain (441) may be formed at a position spaced apart from the first drain (431) by a certain distance.

[0190] The second source (442) may be formed on the substrate (401). The second source (442) may be formed at a position spaced apart from the first source (432) by a certain distance.

[0191] The second drain source channel (443) is a second graphene channel (Ch2) through which fluid (L) passes after the first drain source channel (433), and is formed between the second drain (441) and the second source (442), and can be formed on one side of the first drain source channel (433). The second drain source channel (443) can be formed at a position spaced apart from the first drain source channel (433) by a certain distance.

[0192] The first drain (431), second drain (441), first source (432), and second source (442) may, in one embodiment, include polysilicon or a metallic material (e.g., tungsten (W), copper (Cu), aluminum (Al), gold (Au), palladium (Pd)).

[0193] The first drain (431), the second drain (441), the first source (432), and the second source (442) can be formed by a deposition process such as photolithography patterning or CVD as in one embodiment.

[0194] The first drain source channel (433) and the second drain source channel (443) may include graphene. As an example, the first drain source channel (433) and the second drain source channel (443) may be formed through a patterning and graphene deposition process.

[0195]

[0196] FIGS. 20 and 21 are drawings for explaining the operation method of a diagnostic device (2) according to an embodiment of the present invention. FIGS. 22 and 23 are drawings for explaining a transfer curve. FIGS. 24 to 26 are drawings for explaining examples of abnormalities in a biosensor. FIG. 27 is a drawing for explaining the actual flow rate value of a biosensor.

[0197] Referring to FIG. 20, the diagnostic device control unit (26) of the diagnostic device (2) according to one embodiment of the present invention sets the flow rate of the buffer solution to a preset first reference flow rate (S100), determines whether the buffer solution is in normal contact with the biosensor (400) (S200), and if it is determined that the buffer solution is in normal contact with the biosensor (400), the flow rate of the sample solution can be set to a second reference flow rate lower than the first reference flow rate (S300).

[0198] Specifically, referring to FIG. 21, in step S110, the diagnostic device control unit (26) can, as a pre-fill step, operate the pump unit (900) of the biosensor cartridge (1) to form a liquid gate of the biosensor (400) and simultaneously inject a buffer solution into the flow path forming unit (411), and measure the transconductance of the first drain source channel (433) and the second drain source channel (443).

[0199] Transconductance represents the ratio of output current to input voltage and can refer to the slope (Gm) on a transfer curve graph that shows the correlation between the gate voltage and the drain current of each drain-source channel.

[0200] When the solution comes into normal contact with the biosensor (400), that is, when the solution comes into normal contact with the first drain source channel (433) and the second drain source channel (443) in sequence, a liquid gate is formed and a transfer curve as shown in FIG. 22 can be measured.

[0201] On the other hand, if the solution does not come into contact with the biosensor (400) due to bubbles, that is, if the solution does not come into contact with the first drain source channel (433) and the second drain source channel (443), a liquid gate is not formed, and a transfer curve as shown in FIG. 23 can be measured. As shown in FIG. 22 and FIG. 23, the transconductance when abnormal may be smaller than the transconductance when normal.

[0202] In step S120, the diagnostic device control unit (26) can set the flow rate of the buffer solution to a preset first reference flow rate. Specifically, the diagnostic device control unit (26) can increase the rotational speed of the pump actuator (25) so that the flow rate of the buffer solution becomes the first reference flow rate. By setting the flow rate of the buffer solution to a high speed, the time it takes for the solution to reach the biosensor (400) can be minimized, thereby shortening the time required to start testing the sample solution.

[0203] In step S210, the diagnostic device control unit (26) can determine whether the buffer solution is in normal contact with the biosensor (400) as a pre-fill check step.

[0204] The diagnostic device control unit (26) can measure the first transfer curve of the first drain source channel (433) based on the gate voltage (Vgs) and the first drain current (ids1), and measure the second transfer curve of the second drain source channel (443) based on the gate voltage (vgs) and the second drain current (ids1). The diagnostic device control unit (26) can calculate the first transconductance (Gm1) from the first transfer curve and calculate the second transconductance (Gm2) based on the second transfer curve, and determine whether the first transconductance (Gm1) and the second transconductance (Gm2) are normal transconductances based on the result of comparing the first transconductance (Gm1) and the second transconductance (Gm2) with a reference transconductance. The diagnostic device control unit (26) can determine that the buffer solution is in normal contact with the biosensor (400) when the first transconductance (Gm1) and the second transconductance (Gm2) are normal transconductances.

[0205] In one embodiment, the diagnostic device control unit (26) can determine that if the first transfer curve or the second transfer curve is not measured, the buffer solution is abnormally in contact with the biosensor (400) (the buffer solution is not normally in contact with the biosensor (400)).

[0206] As shown in FIG. 24, when the first transconductance (Gm1) and the second transconductance (Gm2) are close to zero, the diagnostic device control unit (26) can determine that the buffer solution is abnormally in contact with the biosensor (400) (that the buffer solution is not normally in contact with the biosensor (400)). In this case, the solution is in contact with the gate (420), but the solution is not in contact with the first drain source channel (433), which is the first graphene channel (Ch1), and the second drain source channel (443), which is the second graphene channel (Ch2), so the liquid gate is not formed and the transfer curve is not measured.

[0207] As shown in FIG. 25, when the second transconductance (Gm2) of the second drain source channel (443) is determined to be normal, but the first transconductance (Gm1) of the first drain source channel (433) is close to 0, the diagnostic device control unit (26) may determine that the buffer solution is abnormally in contact with the biosensor (400) (that the buffer solution is not in normal contact with the biosensor (400)). In this case, unintended bubbles are formed in the first drain source channel (433) so that the transfer curve is not measured, but the transfer curve is measured in the second drain source channel (443).

[0208] As shown in FIG. 26, if the first transconductance (Gm1) of the first drain source channel (433) is determined to be normal, but the second transconductance (Gm2) of the second drain source channel (443) is measured to be lower than the reference transconductance, the diagnostic device control unit (26) may determine that the buffer solution is abnormally in contact with the biosensor (400) (that the buffer solution is not in normal contact with the biosensor (400)). In this case, unintended bubbles are formed in the second drain source channel (443), causing the contact area of ​​the solution to decrease, and the second transconductance (Gm2) is measured to be lower than the reference transconductance.

[0209] In step S220, the diagnostic device control unit (26) can perform a flow rate correction step, and when it is determined that the buffer solution is in normal contact with the biosensor (400) (when it is determined that the first transconductance (Gm1) and the second transconductance (Gm2) are normal transconductances), calculate the actual flow rate value and correct the flow rate of the buffer solution based on the result of comparing the actual flow rate value with the first reference flow rate.

[0210] Specifically, referring to FIG. 27, the diagnostic device control unit (26) can calculate the actual flow rate value based on the time interval (tdelay) between the first time point (t1) when the first transconductance (Gm1) is determined to be normal and the second time point (t2) when the second transconductance (Gm2) is determined to be normal, and the distance (dch12) between the first drain source channel (433) and the second drain source channel (443). That is, the diagnostic device control unit (26) can calculate the actual flow rate value by dividing the distance (dch12) by the time interval (tdelay).

[0211] The diagnostic device control unit (26) can compare the actual flow rate value with the first reference flow rate and correct the rotational speed of the pump actuator (25) to become the first reference flow rate.

[0212] After determining whether the solution is in normal contact with the biosensor through the transconductance (Gm) of the first drain source channel (433) and the second drain source channel (443), the sensing accuracy for the sample solution test can be improved and the reliability of the measurement data can be ensured by performing a correction process that compares the actual flow rate value with the reference flow rate.

[0213] In step S310, the diagnostic device control unit (26) can, as a test step (Test), correct the flow rate of the buffer solution based on the result of comparing the actual flow rate value with the first reference flow rate, and then set the flow rate of the sample solution to a second reference flow rate lower than the first reference flow rate. Specifically, the diagnostic device control unit (26) can reduce the rotational speed of the pump actuator (25) so that the flow rate of the sample solution becomes a second reference flow rate lower than the first reference flow rate. The flow rate of the sample solution can be set to a preset normal speed suitable for testing.

[0214] In step S320, the diagnostic device control unit (26) can determine whether the first transconductance (Gm1) and the second transconductance (Gm2) are normal transconductances based on the result of comparing the first transconductance (Gm1) and the second transconductance (Gm2) with a preset reference transconductance, after setting the flow rate of the sample solution to a second reference flow rate lower than the first reference flow rate as an error detection step.

[0215] Specifically, the diagnostic device control unit (26) can measure the first transfer curve of the first drain source channel (433) based on the gate voltage (Vgs) and the first drain current (ids1), and measure the second transfer curve of the second drain source channel (443) based on the gate voltage (vgs) and the second drain current (ids1). The diagnostic device control unit (26) can calculate the first transconductance (Gm1) from the first transfer curve and calculate the second transconductance (Gm2) based on the second transfer curve, and determine whether the first transconductance (Gm1) and the second transconductance (Gm2) are normal transconductances based on the result of comparing the first transconductance (Gm1) and the second transconductance (Gm2) with a reference transconductance.

[0216] The diagnostic device control unit (26) can determine that the sensor is abnormal or defective if the first transconductance (Gm1) and the second transconductance (Gm2) are not normal transconductances.

[0217] As shown in FIG. 24, when the first transconductance (Gm1) and the second transconductance (Gm2) are close to zero, the diagnostic device control unit (26) may determine that it is abnormal or defective. In this case, the solution is in contact with the gate (420), but the solution is not in contact with the first drain source channel (433), which is the first graphene channel (Ch1), and the second drain source channel (443), which is the second graphene channel (Ch2), so the liquid gate is not formed and the transfer curve is not measured.

[0218] As shown in FIG. 25, when the second transconductance (Gm2) of the second drain source channel (443) is determined to be normal, but the first transconductance (Gm1) of the first drain source channel (433) is close to 0, the diagnostic device control unit (26) may determine that it is abnormal or defective. In this case, unintended bubbles are formed in the first drain source channel (433) so that the transfer curve is not measured, but the transfer curve is measured in the second drain source channel (443).

[0219] As shown in FIG. 26, if the first transconductance (Gm1) of the first drain source channel (433) is determined to be normal, but the second transconductance (Gm2) of the second drain source channel (443) is measured to be lower than the reference transconductance, the diagnostic device control unit (26) may determine that it is abnormal or defective. In this case, unintended bubbles are formed in the second drain source channel (443), causing the contact area of ​​the solution to decrease, and the second transconductance (Gm2) is measured to be lower than the reference transconductance.

[0220] In step S330, if the diagnostic device control unit (26) determines that the transconductance (Gm) of the first drain source channel (433) or the second drain source channel (443) is abnormal or defective, it may indicate that it is abnormal or defective through the display (21b).

[0221]

[0222] Although the present invention has been described in detail through specific embodiments, this is for the purpose of specifically explaining the invention and is not limited thereto. It is evident that modifications or improvements to the present invention are possible by those skilled in the art within the technical scope of the invention.

[0223] All simple variations or modifications of the present invention fall within the scope of the present invention, and the specific scope of protection of the present invention will be clarified by the appended claims.

Claims

1. A biosensor cartridge in which a flow path is formed for the flow of a buffer solution or sample solution, A biosensor disposed in the biosensor cartridge and generating an electrical signal as the buffer solution or the sample solution passes through, and Diagnostic device for analyzing signals received from the above biosensor Includes, The above diagnostic device is, A diagnostic system that sets the flow rate of the buffer solution to a preset first reference flow rate, determines whether the buffer solution is in normal contact with the biosensor, and if it is determined that the buffer solution is in normal contact with the biosensor, sets the flow rate of the sample solution to a second reference flow rate lower than the first reference flow rate.

2. In Paragraph 1, The above biosensor is, substrate, A gate formed on the above substrate and contacted by the buffer solution or the sample solution, A first drain formed on the above substrate, A first source formed on the above substrate, A second drain formed on the above substrate, A second source formed on the above substrate, A first drain-source channel formed between the first drain and the first source and formed on one side of the gate, and A diagnostic system comprising a second drain source channel formed between the second drain and the second source, and formed on one side of the first drain source channel.

3. In Paragraph 2, The above diagnostic device is, A diagnostic system that determines whether the buffer solution is in normal contact with the biosensor based on the result of comparing the first transconductance of the first drain source channel and the second transconductance of the second drain source channel with the preset reference transconductance after setting the flow rate of the buffer solution to a preset first reference flow rate.

4. In Paragraph 3, The above diagnostic device is, A diagnostic system that, when it is determined that the buffer solution is in normal contact with the biosensor, calculates a measured flow rate value and corrects the flow rate of the buffer solution based on the result of comparing the measured flow rate value with the first reference flow rate.

5. In Paragraph 4, The above diagnostic device is, A diagnostic system that calculates the actual flow rate value based on the time interval between the first time point when the first transconductance is determined to be normal and the second time point when the second transconductance is determined to be normal, and the distance between the first drain source channel and the second drain source channel.

6. In Paragraph 3, The above diagnostic device is, A diagnostic system that measures a first transfer curve of a first drain source channel based on a gate voltage and a first drain current, measures a second transfer curve of a second drain source channel based on a gate voltage and a second drain current, and determines whether the buffer solution is in normal contact with the biosensor based on the first transfer curve and the second transfer curve.

7. In Paragraph 6, The above diagnostic device is, A diagnostic system that determines that the buffer solution is abnormally in contact with the biosensor when the first transfer curve or the second transfer curve is not measured.

8. In Paragraph 2, The above diagnostic device is, A diagnostic system that determines whether the first transconductance and the second transconductance are normal transconductances based on the result of comparing the first transconductance of the first drain source channel and the second transconductance of the second drain source channel with a preset reference transconductance after setting the flow rate of the sample solution to the second reference flow rate lower than the first reference flow rate.

9. In Paragraph 8, The above diagnostic device is, A diagnostic system that determines that the biosensor is defective when the first transconductance and the second transconductance are not normal transconductances.

10. A method for controlling a diagnostic device combined with a biosensor cartridge including a biosensor, wherein Step of setting the flow rate of the buffer solution to a preset first reference flow rate, A step of determining whether the above buffer solution is in normal contact with the biosensor, and If it is determined that the buffer solution is in normal contact with the biosensor, the step of setting the flow rate of the sample solution to a second reference flow rate lower than the first reference flow rate. A method including 11. In Paragraph 10, The above biosensor is, substrate, A gate formed on the above substrate and contacted by the buffer solution or the sample solution, A first drain formed on the above substrate, A first source formed on the above substrate, A second drain formed on the above substrate, A second source formed on the above substrate, A first drain-source channel formed between the first drain and the first source and formed on one side of the gate, and It includes a second drain source channel formed between the second drain and the second source, and formed on one side of the first drain source channel, The step of determining whether the above buffer solution is in normal contact with the biosensor is, A method comprising the step of determining whether the buffer solution is in normal contact with the biosensor based on the result of comparing the first transconductance of the first drain source channel and the second transconductance of the second drain source channel with a preset reference transconductance.

12. In Paragraph 11, The step of determining whether the above buffer solution is in normal contact with the biosensor is, A method further comprising the step of, when it is determined that the buffer solution is in normal contact with the biosensor, calculating a measured flow rate value and correcting the flow rate of the buffer solution based on the result of comparing the measured flow rate value with the first reference flow rate.

13. In Paragraph 12, The step of calculating the actual flow rate value and correcting the flow rate of the buffer solution based on the result of comparing the actual flow rate value with the first reference flow rate is A method for calculating the actual flow rate value based on the time interval between the first time point when the first transconductance matches the reference transconductance and the second time point when the second transconductance matches the reference transconductance, and the distance between the first drain source channel and the second drain source channel.

14. In Paragraph 10, The step of determining whether the above buffer solution is in normal contact with the biosensor is, A method comprising the step of measuring a first transfer curve of the first drain source channel based on a gate voltage and a first drain current, measuring a second transfer curve of the second drain source channel based on the gate voltage and a second drain current, and determining whether the buffer solution is in normal contact with the biosensor based on the first transfer curve and the second transfer curve.

15. In Paragraph 14, The step of determining whether the above buffer solution is in normal contact with the biosensor is, A method further comprising the step of determining that the buffer solution is abnormally in contact with the biosensor if the first transfer curve or the second transfer curve is not measured.

16. In Paragraph 11, After the step of setting to a second reference flow rate lower than the first reference flow rate, A method further comprising the step of determining whether the first transconductance and the second transconductance are normal transconductances based on the result of comparing the first transconductance and the second transconductance with a preset reference transconductance.

17. In Paragraph 16, After the step of determining whether the first transconductance and the second transconductance are normal transconductances, A method further comprising the step of determining that the biosensor is defective if the first transconductance and the second transconductance are not normal transconductances.

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