Test strip capable of detecting two biological indicators, and detection method and system thereof

Abstract

This application provides a test strip capable of detecting two biomarkers, and a detection method and system thereof. The test strip includes at least a base layer, a working electrode, a recognition electrode, and a coding electrode. The base layer has a first side and a second side disposed opposite to each other; the working electrode is disposed on the first side and is used to detect at least the first and second biomarkers. The recognition electrode is disposed on the first side, consisting of at least three electrodes, with at least two of them having a conductive relationship to form a recognition circuit with a uniquely corresponding recognition code, each recognition code corresponding to a test strip type. The coding electrode is disposed on the second side, each coding electrode having a unique identification code, and any at least two coding electrodes are conductive to form a preset on / off relationship. A uniquely corresponding correction code is formed based on the identification code and the on / off relationship, and the correction code is used to determine the first correction information of the first working electrode and the second correction information of the second working electrode.

Description

Technical Field

[0001] This application relates to the field of biosensor technology, and in particular to a test strip capable of detecting two biomarkers, as well as the detection method and system thereof. Background Technology

[0002] Electrochemical biosensor test strips have been widely used for the point-of-care testing of biomarkers such as blood glucose, uric acid, and ketone bodies. With the increasing demand for health management among patients with chronic diseases such as diabetes and hypertension, multifunctional test strips capable of simultaneously detecting multiple indicators have become an important development direction. These test strips can obtain at least two test results with a single blood sample and sample addition, greatly improving testing efficiency and reducing patient discomfort.

[0003] However, existing biosensor test strips with multi-index detection capabilities suffer from variations in raw materials and manufacturing processes between different batches, leading to different detection signals for the same concentration of sample on different batches of test strips. This problem is even more complex for multi-index test strips, as the reagent components, reaction principles, and sensitivities of multiple detection indicators differ, and the degree to which they are affected by batch variations also varies. Therefore, independent calibration information needs to be configured for each indicator.

[0004] Currently, the methods for verifying and inputting calibration information are cumbersome and prone to errors, or the logic for reading and encoding calibration information is complex and has a limited capacity to handle the amount of calibration information, making it difficult to meet the calibration requirements of multi-index detection. More critically, dense electrode layouts and complex coding designs on test strips with limited surface space may lead to interference between electrode signals. This problem is even more pronounced for multi-index test strips that require more electrodes, which not only affects the accuracy of test results but may also cause calibration information reading failures.

[0005] Therefore, how to provide a multi-index test paper with a reasonable layout that can accurately and efficiently read multiple calibration information and carry more calibration information has become a technical problem that urgently needs to be solved in this field. Summary of the Invention

[0006] To address the aforementioned issues, this application provides a test strip capable of detecting two biomarkers, along with its detection method and system. The test strip features a rational electrode layout, enabling accurate and efficient reading of multiple calibration information and carrying more calibration data, effectively meeting users' needs for calibration and detection of multiple biomarkers.

[0007] In a first aspect, embodiments of this application provide a test strip capable of detecting two biomarkers, the test strip comprising:

[0008] A base layer having a first side and a second side disposed opposite to each other;

[0009] A working electrode is disposed on the first side, and the working electrode includes at least a first working electrode for detecting a first biomarker and a second working electrode for detecting a second biomarker different from the first biomarker.

[0010] A recognition electrode is disposed on the first side and spaced apart from the working electrode in the sample flow direction. At least three recognition electrodes are provided, with at least two of them having a conductive relationship to form a recognition circuit with a uniquely corresponding recognition code. Each recognition code corresponds to a test strip type.

[0011] Encoding electrodes are disposed on the second side, and the number of encoding electrodes is at least 6. Each encoding electrode has a unique identification code, and at least two encoding electrodes are connected to form a preset on / off relationship. A unique corresponding correction code is formed based on the identification code and the on / off relationship. The correction code is used to determine the first correction information of the first working electrode and the second correction information of the second working electrode.

[0012] In one implementation of this application, the first biomarker corresponds to blood glucose, and the second biomarker corresponds to uric acid.

[0013] In one implementation of this application, the test strip further includes a plurality of detection electrodes disposed on the first side. Any two of the detection electrodes, the identification electrodes, or the encoding electrodes are turned on to form a power-on signal. When the testing instrument receives the power-on signal, it switches from the power-off state to the working state.

[0014] In one implementation of this application, the sum of the number of detection electrodes and the number of recognition electrodes is equal to the number of encoding electrodes, and the positions of the electrodes disposed on the first side and the electrodes disposed on the second side are arranged in a one-to-one correspondence. In the direction perpendicular to the first side, the projections of each pair of correspondingly disposed electrodes at least partially overlap.

[0015] In one implementation of this application, the encoding electrode includes a first encoding electrode and a second encoding electrode. The identification code and on / off relationship of the first encoding electrode are used to determine the first correction information, and the identification code and on / off relationship of the second encoding electrode are used to determine the second correction information. The number of both the first encoding electrode and the second encoding electrode is greater than 2.

[0016] In one implementation of this application, the identification code is formed based on the preset position of the coding electrode. Each correction code corresponds to a set of conversion functions pre-stored in the detection instrument. The conversion functions include a first conversion function for converting a first detection parameter into a first biomarker and a second conversion function for converting a second detection parameter into a second biomarker. The first detection parameter and the second detection parameter are the initial parameters extracted by the first working electrode and the second working electrode, respectively.

[0017] In one implementation of this application, each identification code corresponds to a set of initial conversion functions pre-stored in the detection instrument, and each correction code corresponds to a set of correction parameters pre-stored in the detection instrument. The first biometric and the second biometric are obtained based on the initial conversion functions, the correction parameters, the first detection parameter, and the second detection parameter. The first detection parameter and the second detection parameter are the initial parameters extracted by the first working electrode and the second working electrode, respectively.

[0018] In one implementation of this application, at least two of the encoding electrodes form a first judgment electrode, and at least two of the detection electrodes or the identification electrodes form a second judgment electrode. The number of the first judgment electrodes and the second judgment electrodes are equal and their positions correspond one-to-one. In the direction perpendicular to the first side, the projections of the first judgment electrode and the second judgment electrode at least partially overlap. One of the first judgment electrode and the second judgment electrode is in a connected state and the other is in a disconnected state. The insertion direction of the test strip is determined based on the electrical connection relationship between the first judgment electrode and the second judgment electrode and the detection instrument.

[0019] In one implementation of this application, a first reagent is fixed on the surface of the first working electrode, and a second reagent is fixed on the surface of the second working electrode. The first reagent is one of the following: glucose oxidase or glucose dehydrogenase, and the second reagent is uricase.

[0020] Secondly, embodiments of this application also provide a detection method for a test strip capable of detecting two biomarkers, the method comprising the following steps:

[0021] Power-on: Any two conductive electrodes in the test strip are electrically connected to the conductive terminals of the testing instrument to form a power-on signal, which causes the testing instrument to switch from the power-off state to the working state;

[0022] Identifying insertion direction: The test strip also includes a first judgment electrode and a second judgment electrode. The first judgment electrode and the second judgment electrode are electrically connected to the conductive terminals of the detection instrument to form an insertion direction identification signal. The detection instrument outputs the insertion direction information of the test strip based on the insertion direction identification signal.

[0023] Identifying test strip type: The identification electrode contacts the conductive terminal of the detection instrument to form an identification code, and the detection instrument confirms the test strip type through the identification code;

[0024] Determine calibration information: The coded electrode is electrically connected to the conductive terminal of the detection instrument to form a calibration code. The detection instrument displays the calibration code and determines the first calibration information of the first working electrode and the second calibration information of the second working electrode through the calibration code.

[0025] In one implementation of this application, the determination of correction information further includes:

[0026] Each of the calibration codes corresponds to a set of conversion functions. The detection instrument converts the first detection parameter into the first biological indicator through the first conversion function in the conversion function, and converts the second detection parameter into the second biological indicator through the second conversion function in the conversion function. The first detection parameter and the second detection parameter are the initial parameters extracted by the first working electrode and the second working electrode, respectively.

[0027] In one implementation of this application, after determining the correction information, the method further includes:

[0028] Each identification code corresponds to a set of initial conversion functions. The detection instrument determines the initial conversion function through the identification code, and converts the first detection parameter into the first biometric through the first initial conversion function and the first correction information in the initial conversion function. It also converts the second detection parameter into the second biometric through the second conversion function and the second correction information in the initial conversion function. The first detection parameter and the second detection parameter are the initial parameters extracted by the first working electrode and the second working electrode, respectively.

[0029] Thirdly, embodiments of this application also provide a detection system for a test strip capable of detecting two biomarkers, the detection system comprising:

[0030] The test strip as described above; the testing instrument, wherein the testing instrument includes:

[0031] A slot for receiving the test strip; a conductive terminal disposed in the slot for electrically connecting to the electrode when the test strip is inserted; a processor electrically connected to the conductive terminal; a memory and a computer program stored in the memory and capable of running on the processor; and a display screen for displaying the calibration code, the first biometric, and the second biometric.

[0032] Compared with the prior art, the significant advantages of this application are as follows:

[0033] The test strip provided in this application adopts a dual-sided functional partition. First, the first side contains working electrodes and recognition electrodes for detecting biological indicators and identifying the test strip type. The second side contains coding electrodes for determining calibration codes. This rational electrode layout makes the functional partition logic of the test strip clearer, effectively reducing the complexity of the recognition algorithm design at the instrument end, so as to accurately and efficiently read multiple calibration information. Second, the functional partition physically isolates detection and calibration, optimizing the utilization of the test strip surface space and effectively reducing the possible interference of electrochemical reactions in the detection area on the coding signal. At the same time, for the coding electrodes, the unique identification code and the on / off relationship between the electrodes are used to form calibration codes. The available information in both dimensions can form more calibration codes, effectively improving the test strip's ability to accommodate and be compatible with calibration parameters. It can achieve an exponential increase in information carrying capacity with a limited number of coding electrodes to meet the coding needs of more calibration parameters.

[0034] In summary, the test strip with a reasonable layout provided in this application can not only perform multi-index detection, but also accurately and efficiently read multiple calibration information and carry a larger volume of calibration information, effectively meeting users' needs for calibration and detection of multiple biological indicators. Attached Figure Description

[0035] The accompanying drawings, which are included to provide a further understanding of this application and form part of this application, illustrate exemplary embodiments and are used to explain this application, but do not constitute an undue limitation of this application. In the drawings:

[0036] Figure 1 This is a double-sided comparison image of a test strip capable of detecting two biomarkers according to an embodiment of this application.

[0037] Figure 2 This is a comparison diagram of the detection electrode, recognition electrode, and encoding electrode in the embodiments of this application;

[0038] Figure 3 This is a connectivity diagram of the coding electrodes in the embodiments of this application;

[0039] Figure 4This is a connectivity diagram of one type of coding electrode in an embodiment of this application;

[0040] Figure 5 This is another connectivity combination diagram of the coding electrodes in the embodiments of this application;

[0041] Figure 6 This is a flowchart illustrating a detection method in an embodiment of this application;

[0042] Figure 7 This is a schematic diagram of the structure of a detection system according to an embodiment of this application. Detailed Implementation

[0043] To make the objectives, technical solutions, and advantages of this application clearer, the technical solutions of this application will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of them. Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0044] This application provides a test strip capable of detecting two biomarkers, as well as a detection method and system thereof. The test strip with multiple biomarkers features a reasonable electrode layout and achieves accurate and efficient reading of multiple calibration information and the ability to carry more calibration information, effectively meeting the user's needs for calibration and detection of multiple biomarkers.

[0045] The various embodiments of this application are described in detail below with reference to the accompanying drawings.

[0046] Figure 1 This is a double-sided comparison image of a test strip capable of detecting two biomarkers, provided as an embodiment of this application.

[0047] Reference Figure 1The test strip includes a base layer 101, a working electrode, a recognition electrode 104, and a coding electrode 105. The base layer 101 has a first side 101a and a second side 101b disposed opposite to each other. The working electrode is disposed on the first side 101a and includes at least a first working electrode 102 for detecting a first biomarker and a second working electrode 103 for detecting a second biomarker different from the first biomarker. The recognition electrode 104 is disposed on the first side and spaced apart from the working electrode in the sample flow direction. At least three recognition electrodes 104 are provided, and at least two of them are electrically connected to form a recognition circuit with a uniquely corresponding recognition code. Each recognition code corresponds to a test strip type. Encoding electrodes 105 are disposed on the second side 101b. The number of encoding electrodes 105 is at least 6. Each encoding electrode 105 has a unique identification code. Any at least two encoding electrodes 105 are connected to form a preset on / off relationship. A unique corresponding correction code is formed based on the identification code and the on / off relationship. The correction code is used to determine the first correction information of the first working electrode 102 and the second correction information of the second working electrode 103.

[0048] It is understood that the test strip provided in this application adopts a double-sided functional partition. First, the first side 101a includes a working electrode and a recognition electrode 104 for detecting biological indicators and identifying the test strip type. The second side 101b includes a coding electrode 105 for determining the correction code. The test strip has a reasonable electrode layout, which makes the functional partition logic of the test strip clearer and can effectively reduce the complexity of the recognition algorithm design at the instrument end, so as to accurately and efficiently read multiple correction information. Secondly, the functional partition also physically isolates detection and correction, optimizes the utilization rate of the test strip surface space, and can effectively reduce the possible interference of electrochemical reactions in the detection area on the coding signal.

[0049] Meanwhile, for the coding electrode 105, the unique identification code and the on / off relationship between the electrodes are used to form a correction code. The available information in the two dimensions can form more correction codes, effectively improving the test paper's ability to accommodate and be compatible with correction parameters. It can achieve an exponential increase in information carrying capacity with a limited number of coding electrodes to meet the coding requirements of more correction parameters.

[0050] The first and second correction information mentioned above can specifically include: the slope of the calibration curve for blood glucose testing. ,intercept The slope of the calibration curve for uric acid testing ,intercept The temperature compensation algorithm for this batch of test strips, and the correction factor for a specific HCT range, etc. The parameters included in the calibration information are merely illustrative and are not specifically limited herein.

[0051] In this embodiment, the first biomarker that the test strip can detect corresponds to blood glucose, and the second biomarker corresponds to uric acid. At this time, a first reagent is fixed on the surface of the first working electrode 102, and a second reagent is fixed on the surface of the second working electrode 103. The first reagent is one of the following: glucose oxidase or glucose dehydrogenase, and the second reagent is uricase.

[0052] In practical applications, the detectable biomarkers of test strips include, but are not limited to, the two biomarkers mentioned above, and can also be combinations of other biomarkers, such as blood glucose and blood ketones. Test strips used to detect different combinations of biomarkers correspond to different test strip types, such as blood glucose and uric acid test strips and blood glucose and blood ketone test strips. The specific combination of detectable biomarkers for test strips can be set according to the actual application scenario, and this application does not make any specific limitations on this.

[0053] In one embodiment of this application, the number of biomarkers that the test strip can detect is not limited to two, but can also include three or more. Specifically, the test strip can be provided with three or more working electrodes to detect different biomarkers respectively. By setting multiple recognition electrodes 104 and forming a recognition circuit corresponding to the test strip type that can detect three or more biomarkers, and the recognition circuit has a unique identification code to confirm the corresponding test strip type. To be able to recognize more test strip types, more recognition electrodes 104 can also be set. The number of recognition electrodes 104 and the number of recognition circuits formed can be set in actual use scenarios, and this application does not make specific limitations here. At the same time, from the on / off relationship combinations that can be formed by the encoding electrodes 105, one on / off combination formed by the encoding electrodes 105 is set and made to correspond to a correction code that can detect three or more biomarkers. The number of encoding electrodes 105 and the number of on / off relationships formed can be set in actual use, and is not specifically limited here.

[0054] Furthermore, the structural design of the test strips provided in this application can be adopted for different types of test strips. If other types of test strips are to be produced, only the reagents fixed on the surfaces of the first working electrode 102 and the second working electrode 103 need to be replaced, provided that the structure of the test strips provided in this application remains unchanged. This design significantly reduces the R&D cycle, mold costs, and inventory management difficulty, making it exceptionally simple and efficient to expand test strips with multiple index combinations in the future.

[0055] In this embodiment of the application, the test strip also includes a plurality of detection electrodes 106 disposed on the first side 101a. Any two of the detection electrodes 106, the identification electrode 104 or the encoding electrode 105 are turned on to form a power-on signal. When the detection instrument receives the power-on signal, it switches from the power-off state to the working state.

[0056] In other words, as long as the test strip of this application contains two electrodes with a conductive relationship and has a conductive signal after being inserted into the testing instrument, this conductive signal corresponds to a power-on signal and is received by the testing instrument. At this time, the testing instrument can complete the power-on action from the power-off state to the working state. After the test strip is inserted into the testing instrument, among the electrodes of the test strip inserted into the slot of the instrument and in contact with the conductive terminals in the slot, two electrodes have conductive wires on the test strip. At this time, the testing instrument and the test strip can form a conductive circuit, and the testing instrument can be powered on.

[0057] refer to Figure 1 In this application, the detection electrode 106 is connected to the electrodes in the detection working area of ​​the test strip by a wire. This wire transmits the electrical signal from the detection instrument to each electrode in the detection working area, establishing a detection circuit loop, and sends the signal from the electrodes in the detection working area to the detection instrument during sample index detection. The detection working area includes the following electrodes: a hematocrit (HCT) electrode, located on the first side and near the inlet of the sample inlet channel; the HCT electrode includes a first HCT electrode 107 and a second HCT electrode 108 for sample detection and AC impedance testing; one or more counter electrodes 109, located on the first side 101a, adjacent to the first working electrode 102 and the second working electrode 103, forming a measurement circuit with the first working electrode 102 and the second working electrode 103; and a full blood detection electrode 110, located on the first side 101a and far from the inlet of the sample inlet channel, used to detect whether the sample fills the entire sample inlet channel and reaches a designated position to trigger the start of detection. The inlet is located at the very front of the test strip, and the sample is introduced through a siphon effect. The first HCT electrode 107, the second HCT electrode 108, the first working electrode 102, the second working electrode 103, and the full blood detection electrode 110 are arranged sequentially along the sample flow direction.

[0058] In this application, the first working electrode 102 and the second working electrode 103, as well as the HCT electrode, the full-blood detection electrode 110, and the counter electrode 109, are arranged sequentially along the sample injection channel in the same reaction chamber according to hydrodynamic and electrochemical order, forming a multi-electrode sequential layout based on a single channel. This layout allows a drop of blood sample to flow sequentially through and cover all electrodes under the siphon effect, thereby enabling the simultaneous detection of two indicators with a single sample addition and a single reaction. This significantly reduces the required blood volume, avoids the pain of multiple blood draws for patients, simplifies the operation steps, and improves the efficiency of multi-indicator joint detection.

[0059] This application does not specifically limit the position of any two electrodes used to generate the power-on signal. These two electrodes can be two electrodes in the detection electrode 106, two electrodes in the identification electrode 104, or two electrodes in the encoding electrode 105. They can also be any two electrodes in the detection electrode 106 and the identification electrode 104. For the two electrodes in the test strip used to enable the detection instrument to start, this application does not specifically limit their position, as long as the structural design allows for electrical connection between the two electrodes.

[0060] For example, the two electrodes that form the power-on signal are... Figure 1 The detection electrode can be any two electrodes in the region of the identification electrode 104 or any two electrodes in the region of the encoding electrode 105. Taking the identification electrode 104 as an example, when the test strip is inserted into the slot of the detection instrument, the conductive terminal in the slot contacts the electrode in the region of the identification electrode 104. The detection instrument forms a power-on trigger circuit with the two conductive electrodes in the identification electrode 104 through the conductive terminal. At this time, the detection instrument receives the power-on signal, thereby waking up and entering the working state from the power-off state (or sleep state).

[0061] In one embodiment of this application, if the testing instrument is configured such that only one side of the conductive terminal in the slot can be used to participate in receiving the power-on signal, in order to enable the test paper to be powered on when inserted in reverse, any two electrodes are provided on both sides of the test paper to conduct and form a power-on signal.

[0062] In another embodiment of this application, the identification electrode 104, in addition to being used for powering on, can also be used for identifying the test strip type. Specifically, at least three identification electrodes 104 are provided, and at least two of them are conductive, thereby forming an identification circuit with a unique identification code that corresponds to the test strip type.

[0063] In other words, for the first type of test strip, two conductive electrodes can be set. When the test strip is inserted into the instrument, and the conductive terminals in the instrument slot make electrical contact with the two identification electrodes 104, the conductivity relationship is extracted and an identification code corresponding to the conductivity relationship is determined. This identification code is recognized by the detection instrument and used to determine its corresponding test strip type. For the second type of test strip, three or more conductive electrodes can be set. When the test strip is inserted into the detection instrument, and the conductive terminals in the slot make contact with the three or more identification electrodes 104, the detection instrument extracts the conductivity relationship of these identification electrodes 104 and determines the identification code. This identification code is recognized by the detection instrument and its test strip type is determined.

[0064] In one embodiment, inserting the test strip into the testing instrument causes the conductive terminals in the slot to contact the identification electrode 104. The testing instrument forms a power-on trigger circuit through the conductive terminals and the two conductive electrodes in the identification electrode 104. At this time, the testing instrument receives a power-on signal and switches from the power-off state to the working state. Simultaneously, the identification electrode 104 is configured with at least three electrodes, at least two of which are conductive to form an identification circuit with a unique identification code. Each identification code corresponds to a test strip type. That is, in addition to automatically powering on, the identification electrode 104 can further identify the test strip type. Thus, the identification electrode 104 has the dual functions of automatic power-on and test strip type identification. The conductive terminals of the testing instrument contact the identification electrode 104 and extract the connection relationship between the corresponding electrodes to obtain the power-on signal and the identification code. This achieves a three-in-one, plug-and-play effect from test strip insertion to instrument startup and model confirmation, eliminating the need for additional power-on electrodes besides the identification electrode 104, simplifying electrode design. In addition, this setting allows the testing instrument to identify the test strip type instantly upon power-on, completely eliminating the hassle of waiting for the instrument to start and manually selecting the test strip type. This greatly improves product usability, significantly shortens instrument response time, and enhances the user experience.

[0065] Furthermore, the biometrics that different testing instruments on the market can detect may vary. Different types of test strips correspond to different biometrics or combinations of biometrics. For example, one type of testing instrument can only detect one type of test strip, while another type can detect two or more types. When a testing instrument can only detect one type of test strip, if the instrument recognizes that the current identification code does not match the type of test strip it can detect, it will report an error. This error can be displayed on the instrument's screen or accompanied by sound or light signals to alert the user that the currently inserted test strip type is incorrect. If the identification code matches the type of test strip it can detect, the subsequent testing and biometric display will continue. When a testing instrument can detect two or more types of test strips, it can also identify the test strip type through the identification code, thereby distinguishing the currently detected biometrics for subsequent testing and display on the instrument's screen.

[0066] refer to Figure 2 In this embodiment, the sum of the number of detection electrodes 106 and recognition electrodes 104 is equal to the number of encoding electrodes 105, and the positions of the electrodes disposed on the first side 101a and the second side 101b are arranged in a one-to-one correspondence. In the direction perpendicular to the first side, the projections of each pair of correspondingly disposed electrodes at least partially overlap.

[0067] In other words, the two sides of the test strip have the same electrode arrangement at the ends where they are inserted into the testing instrument. For example, if there are 10 coding electrodes 105, then there are a total of 10 electrodes for the detection electrodes 106 and the identification electrodes 104. The projection positions of these 10 electrodes in the first side 101a and the 10 coding electrodes in the second side 101b are symmetrically distributed in the direction perpendicular to the first side 101a. The projection positions of each identification electrode 104, detection electrode 106, and coding electrode 105 are respectively matched with the positions of a set of double-sided conductive terminal contacts in the slot of the testing instrument. Moreover, in the direction perpendicular to the first side 101a, the contact connection areas of the identification electrodes 104 and detection electrodes 106 and the contact connection areas of the corresponding coding electrodes 105 occupy at least partially overlapping geometric areas on the substrate layer 101, so that the testing instrument can be electrically connected to the electrodes of the first side 101a and the second side 101b simultaneously through a set of double-sided contacts. In other words, the conductive terminals in the two contact surfaces of the test paper in the slot of the testing instrument are arranged symmetrically.

[0068] The contact connection areas of the identification electrode 104 and the detection electrode 106 and the contact connection area of ​​the corresponding encoding electrode 105 occupy at least partially overlapping geometric areas on the base layer 101, forming contact areas that contact the conductive terminals of the detection instrument. The contact portion of the conductive terminals of the detection instrument slot contacts these contact areas. This arrangement allows the conductive terminals of the detection instrument to be symmetrically arranged within the test strip insertion area, simplifying the slot design. Whether the test strip is inserted forward or backward, it ensures that the electrodes of the test strip contact the conductive terminals of the detection instrument and that the instrument can be powered on, facilitating fault diagnosis of the detection instrument.

[0069] In layman's terms, the electrodes on the front and back of the test strip that connect to the conductive terminals of the testing instrument are arranged symmetrically. The positions of the electrodes on both sides correspond physically, and the contacts that make contact with the conductive terminals are symmetrical. With this design, during production, only different circuit patterns need to be printed on the front and back of the substrate layer. The conductive terminals of the slots that contact them can be designed identically on both sides, without the need for complex mechanical structures. Specifically, the contacts of the slots can be designed as double-sided springs (for example, 10 pairs of springs when there are 10 coding electrodes 105). Regardless of whether the test strip is inserted in the front or back, the springs can accurately contact the corresponding pins. This symmetrical layout simplifies the slot structure, thereby effectively reducing the manufacturing cost of the instrument slots, improving production yield and assembly efficiency, and greatly simplifying the assembly and production process.

[0070] Users sometimes insert test strips backwards into the testing instrument. Even with the electrodes on the reverse and front sides symmetrically positioned, the different connectivity between the electrodes can cause problems such as the test strip being inserted incorrectly, resulting in the instrument being able to power on but failing to recognize the test strip type or correct the code. To avoid the inability to perform normal indicator testing due to reversed test strip insertion, this application also provides the following embodiments.

[0071] Specifically, at least two of the coding electrodes 105 form a first judgment electrode, and at least two of the detection electrodes or identification electrodes form a second judgment electrode. The number of the first judgment electrodes and the second judgment electrodes are equal and their positions correspond one-to-one. In the direction perpendicular to the first side, the projections of the first judgment electrodes and the second judgment electrodes at least partially overlap. One of the first judgment electrodes and the second judgment electrodes is in a connected state and the other is in a disconnected state. The insertion direction of the test strip is determined based on the electrical connection relationship between the first judgment electrodes and the second judgment electrodes and the detection instrument.

[0072] refer to Figure 1 The first judgment electrode includes 105a and 105b. On the first side surface 101a, two electrodes located symmetrically to these two electrodes serve as the second judgment electrode. The electrical connections of the first and second judgment electrodes are different; for example, 105a and 105b are always connected, while the two electrodes on the first side surface 101a are disconnected. Based on the configuration of the first and second judgment electrodes, when the test strip is inserted backwards, the detection instrument contacts the judgment electrode through a conductive terminal and receives the insertion direction identification signal generated by the first judgment electrode. The detection instrument determines that the test strip is inserted backwards based on the insertion direction identification signal, and then outputs insertion direction information, such as an audio prompt saying "Test strip inserted backwards," or displays the text "Test strip inserted backwards" on the display interface. The insertion direction identification signal can be generated by the detection instrument extracting the connection relationship of the first judgment electrode, or by the detection instrument extracting the connection relationship of the second judgment electrode (no signal when the electrodes are disconnected can also serve as an identification signal), or the detection instrument can extract the connection relationship of the first and second judgment electrodes and combine the two to generate the insertion direction identification signal. The specific method for acquiring the connection method identification signal can be set according to the actual use scenario, and this application does not impose specific limitations on it.

[0073] In addition, this application can also provide more than three judgment electrodes for judging the orientation of insertion. As long as the structure ensures that the first judgment electrode preset on the first side can generate a different conduction relationship signal than the second judgment electrode on the second side, it can be used for orientation recognition. This application does not specifically limit the number and method of setting judgment electrodes.

[0074] Therefore, through the aforementioned setting of the judgment electrodes, the circuit composed of the detection electrode 106 and the identification electrode 104 on the first side 101a has a different on / off structure than the encoding circuit composed of the encoding electrode 105 on the second side 101b. The detection instrument only needs to detect the initial signal characteristics of the specific pin corresponding to the judgment electrode to immediately determine the test strip orientation. At the moment of insertion, the detection instrument can immediately determine whether the test strip is inserted backwards at the hardware level by detecting the signal characteristics of the specific pin. If it is determined to be inserted backwards, the instrument will immediately report an error and provide a prompt. This hardware-level anti-reverse insertion judgment is faster and more reliable than software judgment, effectively preventing detection failures or equipment damage caused by user misoperation, and improving the robustness of the product.

[0075] In this embodiment, the encoding electrode 105 forms an identification code based on a preset position, meaning that each preset position of the encoding electrode 105 has a unique identification code. Furthermore, each encoding electrode 105 in this application also has a preset on / off relationship. Based on the unique identification code of the encoding electrode 105, the on / off relationships between the encoding electrodes 105 are combined, theoretically resulting in a Bell number of connected combinations corresponding to the number of encoding electrodes 105. A correspondence is established between the identification code of the encoding electrode 105 and the on / off relationships obtained from the connected combinations, and a correction code is established. The correction code and its corresponding first correction information and second correction information are stored in the detection instrument. For example, if there are 10 encoding electrodes 105, then their Bell number... This means there are 115,975 possible on / off connections. One of these connections is selected, and the corresponding on / off relationship is set using an identifier code. It is evident that this method, through the structural design of the coding electrode 105, allows a large number of test strips to correspond to different correction codes without repetition.

[0076] Furthermore, the above embodiments treat all coded electrodes as a whole and connect them to obtain a unique correction code. However, for the test strip of this application that can detect two biomarkers, generating a separate correction code for each biomarker for users to view and compare makes it more convenient for users to view and verify the correction codes according to the biomarkers. Therefore, this application also provides the following embodiments:

[0077] The encoding electrode includes a first encoding electrode and a second encoding electrode. The identification code and on / off relationship of the first encoding electrode are used to determine the first correction information, and the identification code and on / off relationship of the second encoding electrode are used to determine the second correction information. The number of both the first encoding electrode and the second encoding electrode is greater than 2.

[0078] In other words, the multiple coding electrodes 105 can be divided into two groups (i.e., the coding electrodes 105 can be partitioned), and the number of coding electrodes in each group of coding electrodes 105 is at least greater than 2. For example, there are 10 coding electrodes in total, of which 4 are first coding electrodes and 6 are second coding electrodes. Based on the identifier code of the first coding electrode, the first coding electrode can be connected and combined, theoretically, there can be... =15 combinations The number represents a Bell number of 4; and based on the identification code of the second encoding electrode, the theoretically possible combination of the second encoding electrode is: =203 combinations. For the on / off relationship of the first coding electrode, one combination that enables circuit connection can be set to correspond to an independent correction code. For the on / off relationship of the second coding electrode, one combination that supports circuit connection can be set to correspond to another independent correction code. The two correction codes correspond to the first correction information of the first biometric and the second correction information of the second biometric, respectively. Here, the first coding electrode has 4 electrodes and the second coding electrode has 6 electrodes, which is only an example and is not specifically limited.

[0079] refer to Figure 3 Taking 10 coding electrodes 105 as an example, the identification code can be understood as 1, 2, 3...10. The coding principle of the coding electrode 105 is to perform connection or disconnection (circuit breaking) processing after the printed circuit. Each connection relationship can correspond to a correction code. Figure 3 All 10 coded electrodes 105 are in a connected state, which is the initial state after the circuit diagram is printed. This also corresponds to a correction code (i.e., 1&2&3&4 are connected, 5&6&7&8&9&10 are connected, named 000). Later, by cutting the path with a laser cutter, different connection / disconnection methods will appear, corresponding to different correction codes. In the upper area, the coded electrodes 105 (1, 2, 3, 4) can achieve 14 connection methods, corresponding to the numbers (0-1-2-3-4-5-6-7-8-9-ABCD). In the lower area, the coded electrodes 105 can achieve 178 connection methods, corresponding to the numbers (00-0F 10-1F 20-2F------90-9F A0-AF B0-B1), which is equivalent to 0-9 followed by AF, similar to a hexadecimal naming system.

[0080] refer to Figure 4 , Figure 5 The 105-part coded electrode can be divided into two regions: an upper region with four electrodes (e.g., corresponding to blood glucose) and a lower region with six electrodes (e.g., corresponding to uric acid). An example of the on / off mode is provided below. Figure 4The diagram illustrates a connection / disconnection combination. By using laser cutting to disconnect the electrode with identifier code 1 from the other coded electrodes 105, a new connection / disconnection mode emerges: 1 is independent, 2, 3, and 4 are connected, and 5, 6, 7, 8, 9, and 10 are connected. The correction code can then be named 100, where 1 represents the current connection mode of the upper region and 00 represents the connection mode of the lower region. This combined correction code 100 simultaneously contains correction information for both blood glucose and uric acid. Alternatively, 1 can be used as the first correction code, and 00 as the second correction code, with the first and second correction codes corresponding to the first and second correction information, respectively.

[0081] For example Figure 6 The diagram illustrates a combination of on / off connections. By using laser cutting to disconnect the coded electrode 5 from the other coded electrodes 105, a new on / off configuration emerges: 1, 2, 3, and 4 are connected, 5 is independent, and 6, 7, 8, 9, and 10 are connected. The correction code can then be named 001, where 0 represents the current connectivity of the upper region and 01 represents the connectivity of the lower region. This generates a combined correction code 001 that simultaneously contains correction information for both blood glucose and uric acid.

[0082] In this application, the connection and switching arrangement of multiple encoding electrodes 105 allows for not only overall encoding but also partitioned encoding by dividing the circuit logic into multiple independent sub-regions, each responsible for the correction encoding of a specific indicator. This connection and combination method of the encoding electrodes 105 enables an exponential increase in encoding capacity. A limited number of electrodes (e.g., 6-10) can provide far greater... This unique coding combination can simultaneously include batch information of the test strip, independent algorithmic correction parameters for two indicators, and expiration date warning information for the test strip. This design allows the calibration code corresponding to the coded electrode to carry a huge amount of information. It also enables the instrument to perform independent and precise calibration for each detection indicator, effectively compensating for sensitivity differences between different batches and indicators, and ensuring high-precision multi-indicator detection results.

[0083] In this embodiment, an identification code is formed based on the preset position of the coding electrode 105. Each correction code corresponds to a set of conversion functions pre-stored in the detection instrument. The conversion functions include a first conversion function for converting a first detection parameter into a first biometric and a second conversion function for converting a second detection parameter into a second biometric. The first detection parameter and the second detection parameter are the initial parameters extracted by the first working electrode and the second working electrode, respectively.

[0084] In other words, the calibration code of the test strip corresponds to a pre-stored conversion function in the testing instrument. After the test strip is inserted into the instrument and the process is completed (power on, confirmation of correct insertion, confirmation of correct test strip type, confirmation of calibration code), the instrument can match the conversion function corresponding to the calibration code from the pre-stored information. This conversion function can combine the first calibration information and the second calibration information corresponding to the calibration code to process and convert the first detection parameter collected by the first working electrode and the second detection parameter collected by the second working electrode to obtain the first biometric and the second biometric. The testing instrument can also be configured to include the first calibration information and the second calibration information in the conversion function, depending on the actual usage scenario. The conversion function can generally be in the form y = a*x + b, where y represents the biometric, x represents the detection parameter, and a and b can represent the parameters in the calibration information. Different calibration codes can be pre-set with different conversion functions, and the conversion function can also be in other forms, depending on the actual usage scenario. This application does not impose specific limitations on this.

[0085] In another embodiment of this application, each identification code corresponds to a set of initial conversion functions pre-stored in the detection instrument, and each correction code corresponds to a set of correction parameters pre-stored in the detection instrument. The first biometric and the second biometric are obtained based on the initial conversion function, the correction parameters, the first detection parameter and the second detection parameter, respectively. The first detection parameter and the second detection parameter are the initial parameters extracted by the first working electrode and the second working electrode, respectively.

[0086] In one implementation, the identification code of the test strip can correspond to the initial conversion function. After the testing instrument determines the test strip type, it can call the initial conversion function and use it to convert the first detection parameter and the second detection parameter. Then, after waiting for confirmation of the correction code, the correction parameter is obtained. The first detection parameter and the second detection parameter after conversion are corrected using the correction parameter. After the correction is completed, the first biological indicator and the second biological indicator are obtained.

[0087] In another implementation, the identification code of the test strip corresponds to the initial conversion function. After the testing instrument determines the test strip type, it can call the initial conversion function. Then, after waiting for confirmation of the correction code, it obtains the correction parameters. The initial conversion function and the correction parameters are combined into a conversion function. The conversion function is used to convert the first detection parameter and the second detection parameter to obtain the first biometric and the second biometric.

[0088] This application may use either of the two methods described above for determining biometrics using the initial transformation function, or may set other methods for determining biometrics using the initial transformation function in actual use, without specific limitations.

[0089] Taking the combination of an initial conversion function and correction parameters as an example, the detection instrument pre-stores the aforementioned initial conversion function when calculating biometrics. For different test strip types, this initial conversion function can be the same or a universal function, or different functions can be set for different test strip types according to the actual usage scenario. This application does not make specific limitations in this regard. The correction code corresponds to the first correction parameter and the second correction parameter combined with the initial conversion function. The instrument determines the correction parameters, such as a and b, through the correction code and inputs them into the initial conversion function to form the conversion function. Then, the first detection parameter and the second detection parameter are respectively input into the conversion function to calculate the first biometric and the second biometric.

[0090] Figure 6 This is a schematic flowchart illustrating a detection method for a test strip capable of detecting two biomarkers, provided as an embodiment of this application. Figure 6 As shown, it includes the following steps:

[0091] S601, Power On: Any two conductive electrodes in the test strip are electrically connected to the conductive terminals of the testing instrument to form a power-on signal, which switches the testing instrument from the power-off state to the working state.

[0092] S602, Identifying Insertion Direction: The test strip also includes a first judgment electrode and a second judgment electrode. The first judgment electrode and the second judgment electrode are electrically connected to the conductive terminals of the testing instrument to form an insertion direction identification signal. The testing instrument outputs the insertion direction information of the test strip based on the insertion direction identification signal.

[0093] S603, Identifying test strip type: The identification electrode contacts the conductive terminal of the detection instrument to form an identification code, and the detection instrument confirms the test strip type through the identification code;

[0094] S604, Determine calibration information: The coding electrode 105 is electrically connected to the conductive terminal of the detection instrument to form a calibration code. The detection instrument displays the calibration code and determines the first calibration information of the first working electrode and the second calibration information of the second working electrode through the calibration code.

[0095] Specifically, after the test strip is inserted into the testing instrument, the conductive terminals of the instrument's slot form a conductive circuit with the two conductive electrodes on the same side of the test strip, thus receiving a power-on signal and powering on. The testing instrument then determines whether the test strip is inserted correctly or incorrectly by identifying the insertion direction identification signal formed by the first and second judgment electrodes. The signal used to determine the correct insertion state can be a preset correct insertion characteristic signal, which is predetermined by the electrical signal characteristics of the judgment electrodes when the test strip is inserted in the correct direction. If the insertion direction identification signal is inconsistent with the preset correct insertion characteristic signal, the test strip is determined to be inserted incorrectly; otherwise, it is inserted correctly. If it is inserted correctly, S603 continues; if it is inserted incorrectly, the testing instrument can output a correction message, such as an audible alert, to remind the user to reinsert the test strip in the correct direction. When the test strip is in the correct insertion position, the conductive terminal of the detection instrument contacts the recognition electrode 104 on the first side 101a and extracts the conduction relationship of the recognition circuit in the recognition electrode 104. The conduction relationship of the recognition circuit is compared with the pre-stored recognition code comparison information to determine the recognition code corresponding to the conduction relationship of the recognition circuit. The recognition code corresponds to a unique test strip type. The recognition code comparison information contains the correspondence between the conduction relationship of the recognition circuit, the recognition code and the test strip type.

[0096] Subsequently, the detection instrument will extract the continuity relationship between the coding electrodes 105 and determine the identification code of each coding electrode 105 through the conductive terminals in contact with the electrodes on the second side 101b, thereby obtaining the on / off combination between the coding electrodes 105. Then, through a pre-stored calibration code information table, the calibration code corresponding to the on / off combination is determined. That is, the identification code of the coding electrode 105 set on the second side 101b is determined, and the on / off relationship between the coding electrodes 105 is determined, forming a unique calibration code, which is displayed by the detection instrument. Specifically, the calibration code can be displayed on the screen so that the user can compare the calibration code with the calibration code pre-set on the test strip packaging box or other carrier to determine whether there is a problem with the calibration code of the test strip currently inserted into the detection instrument. If the user confirms that they match, the test strip can be used for biometric testing; if they do not match, it means that the test strip is incorrect and cannot be used by the user.

[0097] Once the calibration code passes and the sample is added to the injection channel, the first working electrode in the test strip extracts the first detection parameter, and the second working electrode extracts the second detection parameter. By using the first and second calibration information corresponding to the calibration code, the first and second detection parameters are calibrated to obtain the first and second biological indicators.

[0098] In one embodiment of this application, the above step S604 of determining the correction information further includes:

[0099] Each calibration code corresponds to a set of conversion functions. The detection instrument converts the first detection parameter into a first biological indicator through the first conversion function in the conversion function, and converts the second detection parameter into a second biological indicator through the second conversion function in the conversion function. The first detection parameter and the second detection parameter are the initial parameters extracted by the first working electrode and the second working electrode, respectively.

[0100] For a more detailed example, please refer to the above example regarding the conversion of biometrics using a conversion function in the test strip; further details will not be provided here.

[0101] Furthermore, in one embodiment of this application, the determination of correction information can also be performed through the following embodiments, specifically including:

[0102] Based on the preset positions of each encoding electrode 105 on the second side 101b, a connected graph of N encoding electrodes 105 is constructed; N is a natural number at least greater than 6. The nodes of the connected graph are the N encoding electrodes 105, and each node is uniquely identified based on its preset position. A scanning signal is sequentially applied to each of the N encoding electrodes 105. For each encoding electrode 105 acting as an output electrode, it is checked whether there is a signal input when the other encoding electrodes act as input electrodes. The direct conduction state of each pair of encoding electrodes is recorded based on the preset positions of each encoding electrode 105 to determine whether an edge exists between any two nodes in the connected graph. When it is determined that there is a direct conduction between the i-th encoding electrode 105 and the j-th encoding electrode 105, an edge is established between the i-th node and the j-th node in the connected graph; i is a non-zero natural number, j is a non-zero natural number, and i is not equal to j, i≤N and j≤N, k≤N. When it is determined that there is no direct connection between the i-th coding electrode 105 and the j-th coding electrode 105, based on the preset positions of each coding electrode 105, it is determined whether there exists a k-th coding electrode 105 that allows the i-th coding electrode 105 to be directly connected to the k-th coding electrode 105 and the j-th coding electrode 105, so as to determine whether there is an indirect connection path between the i-th node and the j-th node. After traversing all coding electrodes 105, a complete connected graph is obtained; the connected graph is used to uniquely determine the connection topology between the N coding electrodes 105. The complete connected graph is converted into a graph hash value, and the graph hash value is used as a unique correction code. The algorithm parameter set corresponding to the correction code is matched from the pre-stored mapping table. The algorithm parameter set contains first correction information and second correction information.

[0103] In another embodiment of this application, after determining the correction information in S604 above, the method further includes:

[0104] Each identification code corresponds to a set of initial conversion functions. The detection instrument determines the initial conversion function through the identification code, and converts the first detection parameter into a first biometric through the first initial conversion function and the first correction information in the initial conversion function. It also converts the second detection parameter into a second biometric through the second conversion function and the second correction information in the initial conversion function. The first detection parameter and the second detection parameter are the initial parameters extracted by the first working electrode and the second working electrode, respectively.

[0105] In other words, the testing instrument can store initial conversion functions corresponding to test strip types. If the instrument can detect one or more test strip types, it can pre-store a set of initial conversion functions associated with the identification code corresponding to the test strip type. Once the instrument determines the identification code, it can call the corresponding initial conversion function. Simultaneously, the instrument pre-stores first and second correction information associated with the correction code, using the initial conversion functions and correction information together to correct the initial parameters. For specific implementation details, please refer to the above-mentioned example of obtaining biometrics using initial conversion functions and correction information in the test strip; further elaboration is omitted here.

[0106] Figure 7 A detection system for a test strip capable of detecting two biomarkers is provided in this application embodiment. The detection system includes:

[0107] The above-mentioned test strip 710; testing instrument 720, the testing instrument includes:

[0108] The device includes a slot 721 for receiving a test strip 710; a conductive terminal 722 disposed within the slot 721 for electrically connecting to an electrode when the test strip 710 is inserted; a processor 723 electrically connected to the conductive terminal 722; a memory 724 and a computer program stored in the memory and capable of running on the processor 723; and a display screen 725 for displaying a calibration code, a first biometric, and a second biometric.

[0109] The various embodiments in this application are described in a progressive manner. Similar or identical parts between embodiments can be referred to mutually. Each embodiment focuses on describing the differences from other embodiments. In particular, the method and system embodiments are basically similar to the test strip embodiments, so the descriptions are relatively simple; relevant parts can be referred to the descriptions of the test strip embodiments.

[0110] The methods and systems provided in this application correspond one-to-one with the test strips. Therefore, the methods and systems also have similar beneficial technical effects as their corresponding test strips. Since the beneficial technical effects of the test strips have been described in detail above, the beneficial technical effects of the methods and systems will not be repeated here.

[0111] It should also be noted that the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0112] The above description is merely an embodiment of this application and is not intended to limit the scope of this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of the claims of this application.

Claims

1. A test strip capable of detecting two biomarkers, characterized in that, The test strip includes: A base layer having a first side and a second side disposed opposite to each other; A working electrode is disposed on the first side, and the working electrode includes at least a first working electrode for detecting a first biomarker and a second working electrode for detecting a second biomarker different from the first biomarker. A recognition electrode is disposed on the first side and spaced apart from the working electrode in the sample flow direction. At least three recognition electrodes are provided, with at least two of them having a conductive relationship to form a recognition circuit with a uniquely corresponding recognition code. Each recognition code corresponds to a test strip type. Encoding electrodes are disposed on the second side, and the number of encoding electrodes is at least 6. Each encoding electrode has a unique identification code, and at least two encoding electrodes are connected to form a preset on / off relationship. A unique corresponding correction code is formed based on the identification code and the on / off relationship. The correction code is used to determine the first correction information of the first working electrode and the second correction information of the second working electrode.

2. The test strip according to claim 1, characterized in that, The first biomarker corresponds to blood glucose, and the second biomarker corresponds to uric acid.

3. The test strip according to claim 1, characterized in that, The test strip also includes a plurality of detection electrodes disposed on the first side. Any two of the detection electrodes, the identification electrodes, or the encoding electrodes are turned on to form a power-on signal. When the testing instrument receives the power-on signal, it switches from the power-off state to the working state.

4. The test strip according to claim 3, characterized in that, The sum of the number of detection electrodes and the number of recognition electrodes is equal to the number of encoding electrodes, and the positions of the electrodes disposed on the first side and the electrodes disposed on the second side are arranged in a one-to-one correspondence. In the direction perpendicular to the first side, the projections of each pair of correspondingly disposed electrodes at least partially overlap.

5. The test strip according to claim 1, characterized in that, The encoding electrode includes a first encoding electrode and a second encoding electrode. The identification code and on / off relationship of the first encoding electrode are used to determine the first correction information, and the identification code and on / off relationship of the second encoding electrode are used to determine the second correction information. The number of both the first encoding electrode and the second encoding electrode is greater than 2.

6. The test strip according to any one of claims 1-5, characterized in that, The identification code is formed based on the preset position of the coded electrode. Each correction code corresponds to a set of conversion functions pre-stored in the detection instrument. The conversion functions include a first conversion function for converting a first detection parameter into a first biomarker and a second conversion function for converting a second detection parameter into a second biomarker. The first detection parameter and the second detection parameter are the initial parameters extracted by the first working electrode and the second working electrode, respectively.

7. The test strip according to any one of claims 1-5, characterized in that, Each identification code corresponds to a set of initial conversion functions pre-stored in the detection instrument, and each correction code corresponds to a set of correction parameters pre-stored in the detection instrument. The first biometric and the second biometric are obtained based on the initial conversion functions, the correction parameters, the first detection parameter, and the second detection parameter. The first detection parameter and the second detection parameter are the initial parameters extracted by the first working electrode and the second working electrode, respectively.

8. The test strip according to claim 3, characterized in that, Any two electrodes from the encoding electrodes form a first judgment electrode, and any two electrodes from the detection electrodes or the identification electrodes form a second judgment electrode. The number of the first judgment electrodes and the second judgment electrodes are equal and their positions correspond one-to-one. In the direction perpendicular to the first side, the projections of the first judgment electrodes and the second judgment electrodes at least partially overlap. One of the first judgment electrodes and the second judgment electrodes is in a connected state and the other is in a disconnected state. The insertion direction of the test strip is determined based on the electrical connection relationship between the first judgment electrodes and the second judgment electrodes and the detection instrument.

9. The test strip according to claim 1, characterized in that, A first reagent is fixed on the surface of the first working electrode, and a second reagent is fixed on the surface of the second working electrode. The first reagent is one of the following: glucose oxidase or glucose dehydrogenase, and the second reagent is uricase.

10. The detection method of the test strip according to any one of claims 1-9, characterized in that, Includes the following steps: Power-on: Any two conductive electrodes in the test strip are electrically connected to the conductive terminals of the testing instrument to form a power-on signal, which causes the testing instrument to switch from the power-off state to the working state; Identifying insertion direction: The test strip also includes a first judgment electrode and a second judgment electrode. The first judgment electrode and the second judgment electrode are electrically connected to the conductive terminals of the detection instrument to form an insertion direction identification signal. The detection instrument outputs the insertion direction information of the test strip based on the insertion direction identification signal. Identifying test strip type: The identification electrode contacts the conductive terminal of the detection instrument to form an identification code, and the detection instrument confirms the test strip type through the identification code; Determine calibration information: The coded electrode is electrically connected to the conductive terminal of the detection instrument to form a calibration code. The detection instrument displays the calibration code and determines the first calibration information of the first working electrode and the second calibration information of the second working electrode through the calibration code.

11. The detection method according to claim 10, characterized in that, The determination of correction information also includes: Each of the calibration codes corresponds to a set of conversion functions. The detection instrument converts the first detection parameter into the first biological indicator through the first conversion function in the conversion function, and converts the second detection parameter into the second biological indicator through the second conversion function in the conversion function. The first detection parameter and the second detection parameter are the initial parameters extracted by the first working electrode and the second working electrode, respectively.

12. The detection method according to claim 10, characterized in that, After determining the correction information, the process also includes: Each identification code corresponds to a set of initial conversion functions. The detection instrument determines the initial conversion function through the identification code, and converts the first detection parameter into the first biometric through the first initial conversion function and the first correction information in the initial conversion function. It also converts the second detection parameter into the second biometric through the second conversion function and the second correction information in the initial conversion function. The first detection parameter and the second detection parameter are the initial parameters extracted by the first working electrode and the second working electrode, respectively.

13. A detection system for a test strip capable of detecting two biomarkers, characterized in that, The detection system includes: The test strip as described in any one of claims 1-9; The testing instrument includes: Slot for receiving the test strip; A conductive terminal is disposed in the slot for electrical connection with the electrode when the test strip is inserted. The processor is electrically connected to the conductive terminal; Memory and a computer program stored in said memory and capable of running on said processor; A display screen is used to display the correction code, the first biometric, and the second biometric.

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