Difunctional test strip capable of automatically adjusting codes

Abstract

The utility model provides an automatic code modulation difunctional test strip which comprises a substrate, the substrate is provided with a first coding area and a second coding area, the first coding area is provided with a plurality of first coding electrodes, and the first coding area generates a first digital coding signal for a detection instrument to carry out code modulation on detection of a first index; the second coding area is provided with a plurality of second coding electrodes, and the second coding area generates a second digital coding signal so that the detection instrument can carry out code modulation on detection of a second index. The detection instrument can automatically identify the first digital coding signal generated by the first coding area and the second digital coding signal generated by the second coding area, so that the purpose of automatically carrying out code modulation on detection of the first index and the second index of the detection instrument is achieved, manual code number input is avoided, and the code modulation accuracy and convenience are improved.

Description

Technical Field

[0001] This utility model relates to the field of test strips, and more specifically, to a dual-function test strip with automatic coding. Background Technology

[0002] Currently, single-function blood glucose test strips, uric acid test strips, and blood ketone test strips are common in the market. These strips only have a single reaction zone and can only detect a single indicator. To detect multiple indicators, multiple strips need to be purchased and multiple injections performed, causing inconvenience to users and consuming a large number of strips. To solve these technical problems, Chinese utility model patent CN209086198U provides a dual-function electrochemical test strip for blood glucose and uric acid. By covering the first and second perforations with a first enzyme layer that reacts with uric acid and a second enzyme layer that reacts with blood glucose, it achieves simultaneous detection of blood glucose and uric acid. Users do not need to change equipment for each test, making it more convenient.

[0003] Due to differences in incoming materials, process control, production environment, and manufacturing processes, the sensitivity of test strips from different batches cannot be consistent. To ensure testing accuracy, the testing instrument needs to be coded. Currently, the commonly used coding method is for the user to manually enter the code number. This method is prone to errors, leading to inaccurate testing. Especially when using dual-function test strips, it is necessary to manually enter the code number twice to coded both indicators, increasing the possibility of errors and making the coding operation inconvenient.

[0004] Therefore, there is considerable room for improvement in the existing technology. Utility Model Content

[0005] The purpose of this invention is to overcome the shortcomings of the existing technology and propose a dual-function test strip with automatic coding.

[0006] To achieve the above objectives, this utility model is implemented through the following technical solution:

[0007] This utility model provides a dual-function test strip with automatic coding, including a substrate. The substrate is provided with a first coding area and a second coding area. The first coding area has a plurality of first coding electrodes. The first coding area generates a first digital coding signal for the detection instrument to code the detection of a first index.

[0008] The second coding area has multiple second coding electrodes, and the second coding area generates a second digital coding signal for the detection instrument to adjust the code for detecting the second index.

[0009] By setting a first coding area and a second coding area, the detection instrument can automatically identify the first digital code signal generated by the first coding area and the second digital code generated by the second coding area, thereby achieving the purpose of automatically adjusting the code for the detection of the first and second indicators of the detection instrument, avoiding manual input of code numbers, and improving the accuracy and convenience of code adjustment.

[0010] Understandably, the first and second indicators can be set according to actual needs, such as setting the first indicator to uric acid or blood ketones and the second indicator to blood glucose.

[0011] According to the above scheme, both the first encoding electrode and the second encoding electrode are binary encoding electrodes, and each binary encoding electrode is independently configured as a closed circuit or a closed circuit structure.

[0012] With the above structural setup, multiple detection ends of the detection instrument are respectively connected to multiple first encoding electrodes and second encoding electrodes. Each binary encoding electrode generates one bit of binary signal (when the binary encoding electrode is in a closed circuit structure, it generates a binary signal "1", and when the binary encoding electrode is in a closed circuit structure, it generates a binary signal "0"), thereby obtaining the first digital encoding signal and the second digital encoding signal represented in binary form.

[0013] It is understandable that the number of the first encoding electrode and the second encoding electrode can be set according to actual needs. When there are N first encoding electrodes, the first digital encoded signal has a total of 2... N In a combination of M combinations, a first digital encoding signal is determined during production. Then, based on this first digital encoding signal, it is determined whether each binary encoding electrode in the first encoding area is a closed-circuit structure or an open-circuit structure. When there are M second encoding electrodes, the second digital encoding signal has a total of 2... M A combination; during production, a second digital encoding signal is determined, and then each binary encoding electrode in the second encoding area is determined to be a closed circuit or an open circuit based on the second digital encoding signal.

[0014] According to the above scheme, the substrate is also provided with a power-on electrode. By setting the power-on electrode, when the dual-function test strip is inserted into the testing instrument, the power-on electrode connects the power-on circuit of the testing instrument, enabling the testing instrument to start working.

[0015] According to the above scheme, a check code is also provided on the substrate. The check code is used to verify the accuracy of the first digital encoded signal and the second digital encoded signal, greatly reducing detection anomalies caused by tuning errors. It is understood that in some embodiments, a check code may not be provided.

[0016] According to the above scheme, the first encoding area is disposed on the top surface of the substrate, and the second encoding area is disposed on the bottom surface of the substrate.

[0017] By placing the first coding area and the second coding area on different surfaces of the substrate, it is beneficial to increase the layout area of ​​the first coding area and the second coding area.

[0018] According to the above scheme, the substrate is further provided with an electrode layer, the electrode layer including a plurality of electrodes; the electrode layer is covered with an insulating double-sided adhesive layer, the insulating double-sided adhesive layer is provided with an opening, the substrate and the opening form a sample injection channel, and the opening is covered with a hydrophilic film.

[0019] With the above structural design, the blood sample can be drawn into the injection channel by utilizing the hydrophilicity of the hydrophilic membrane and the siphon effect of the injection channel.

[0020] According to the above scheme, at least a portion of each of the plurality of electrodes is located within the sample injection channel, and the plurality of electrodes includes a first working electrode, a second working electrode, and a reference electrode.

[0021] With the above structural configuration, the first working electrode and the reference electrode form a current loop for detecting the first indicator; the second working electrode and the reference electrode form a current loop for detecting the second indicator.

[0022] According to the above scheme, an enzyme layer is provided on the first working electrode, and the enzyme layer is located within the sample injection channel. This structural arrangement helps to improve detection speed and accuracy.

[0023] Understandably, the types of enzymes in the enzyme layer are selected based on the detection indicators. For example, if the primary indicator is uric acid, the enzymes in the enzyme layer will be those that react with uric acid.

[0024] According to the above scheme, the plurality of electrodes also includes an HCT electrode and a saturation determination electrode.

[0025] The HCT electrode can be reused as both a background electrode and an impedance measurement electrode. When used as a background electrode, a weak DC excitation voltage is applied relative to the reference electrode, allowing the measurement of a weak current—the background current of the blood sample. The magnitude of this background current reflects the purity of the blood sample. When used as an impedance measurement electrode, the sample impedance relative to the working electrode is measured using AC excitation. The proportion of red blood cells in the blood sample is then obtained through algorithmic fitting of the measurement results, effectively avoiding interference from hematocrit (HCT) and improving the accuracy of the test strip. The saturation detection electrode is used to determine whether the blood sample is saturated. When the blood sample flows onto the contact surface of this electrode, there will be a significant step change in impedance between this electrode and the HCT electrode. By detecting the impedance change in this circuit, it is confirmed whether the blood sample has been fully absorbed.

[0026] According to the above scheme, the HCT electrode, the first working electrode, the second working electrode, the reference electrode, and the saturation judgment electrode located in the injection channel are arranged sequentially from the outside to the inside along the injection channel.

[0027] With the above structural design, the fullness judgment electrode is located at the innermost position of the sample injection channel. The fullness judgment electrode and the HCT electrode form a current loop and are also used for fullness judgment. Only when the blood sample basically covers the sample injection channel can it touch the fullness judgment electrode and trigger the instrument to start detection. This effectively avoids the impact of insufficient sample intake on the detection results, thereby improving the accuracy of detection.

[0028] The beneficial effects of this utility model are as follows:

[0029] This invention provides a first encoding area and a second encoding area on a substrate. The first encoding area has multiple first encoding electrodes and generates a first digital encoding signal for the detection instrument to adjust the code for detecting a first indicator. The second encoding area has multiple second encoding electrodes and generates a second digital encoding signal for the detection instrument to adjust the code for detecting a second indicator. The detection instrument can automatically identify the first digital encoding signal generated by the first encoding area and the second digital encoding signal generated by the second encoding area, thereby achieving the purpose of automatically adjusting the code for detecting the first and second indicators of the detection instrument, avoiding manual input of code numbers, and improving the accuracy and convenience of code adjustment. Attached Figure Description

[0030] Figure 1 This is a schematic diagram of the structure of this utility model;

[0031] Figure 2 This is a schematic diagram of the structure of the substrate in this utility model where the top surface is not covered with an insulating double-sided adhesive layer and a hydrophilic film layer;

[0032] Figure 3 This is a schematic diagram of the bottom structure of the substrate in this utility model.

[0033] In the figure: 1. Substrate; 11. First coding area; 111. First coding electrode; 12. Second coding area; 121. Second coding electrode; 13. Power-on electrode; 14. Check code; 2. Electrode layer; 21. HCT electrode; 22. First working electrode; 221. Enzyme layer; 23. Second working electrode; 24. Reference electrode; 25. Immersion judgment electrode; 3. Insulating double-sided adhesive layer; 31. Opening; 4. Hydrophilic membrane. Detailed Implementation

[0034] The embodiments of the present invention will be described in detail below with reference to the accompanying drawings. However, the present invention can be implemented in many different ways as defined and covered by the claims.

[0035] To facilitate understanding of the technical solution, in this embodiment, the first indicator is limited to uric acid and the second indicator is blood glucose. Of course, in other embodiments, those skilled in the art can choose according to actual needs.

[0036] like Figure 1-3 As shown, the present invention provides an automatic coding dual-function test strip, including a substrate 1, on which a first coding area 11 and a second coding area 12 are provided. The first coding area 11 has five first coding electrodes 111. The first coding area 11 generates a first digital coding signal for the detection instrument to code the detection of the first index.

[0037] The second encoding area 12 has six second encoding electrodes 121, and the second encoding area 12 generates a second digital encoding signal for the detection instrument to adjust the code for the detection of the second index.

[0038] By setting the first coding area 11 and the second coding area 12, the detection instrument can automatically identify the first digital coding signal generated by the first coding area 11 and the second digital coding signal generated by the second coding area 12, thereby achieving the purpose of automatically adjusting the code for the detection of uric acid and blood glucose by the detection instrument, avoiding manual input of code numbers, and improving the accuracy and convenience of code adjustment.

[0039] It is understood that in some embodiments, the number of the first encoding electrode 111 and the second encoding electrode 121 may be set to other values.

[0040] Furthermore, both the first encoding electrode 111 and the second encoding electrode 121 are binary encoding electrodes, and each binary encoding electrode is independently configured as a closed circuit or a closed circuit.

[0041] With the above structural configuration, multiple detection terminals of the detection instrument are respectively connected to multiple first encoding electrodes 111 and second encoding electrodes 121, and each binary encoding electrode generates one bit of binary signal. Specifically, when the binary encoding electrode is in a closed-circuit structure, it generates a binary signal "1", and when the binary encoding electrode is in an open-circuit structure, it generates a binary signal "0". The combination of 5 binary encoding electrodes in the first encoding area 11 generates a first digital encoding signal, and the combination of 6 binary encoding electrodes in the second encoding area 12 generates a second digital encoding signal.

[0042] The first digital coded signal has 2 5 There are 32 combinations. During production, a first digital encoding signal is determined for each test strip. Then, based on the first digital encoding signal, it is determined whether each binary encoding electrode in the first encoding area 11 is a closed-circuit structure or an open-circuit structure. The second digital encoding signal has a total of 2... 6There are 64 combinations; during production, a second digital encoding signal is determined, and then each binary encoding electrode in the second encoding area 12 is determined to be a closed circuit or an open circuit based on the second digital encoding signal.

[0043] Furthermore, the substrate 1 is also provided with a power-on electrode 13. By setting the power-on electrode 13, when the dual-function test strip is inserted into the testing instrument, the power-on electrode 13 connects the power-on circuit of the testing instrument, causing the testing instrument to start working.

[0044] Furthermore, the substrate 1 is also provided with a check code 14. The check code 14 is used to verify the accuracy of the first digital encoded signal and the second digital encoded signal, which greatly reduces detection anomalies caused by code modulation errors.

[0045] Furthermore, the first encoding area 11 is disposed on the top surface of the substrate 1, and the second encoding area 12 is disposed on the bottom surface of the substrate 1. By disposing the first encoding area 11 and the second encoding area 12 on different surfaces of the substrate 1, it is beneficial to increase the layout area of ​​the first encoding area 11 and the second encoding area 12.

[0046] Furthermore, the substrate 1 is also provided with an electrode layer 2, which includes multiple electrodes; an insulating double-sided adhesive layer 3 is covered on the electrode layer 2, and an opening 31 is provided on the insulating double-sided adhesive layer 3. The substrate 1 and the opening 31 form a sample inlet channel, and a hydrophilic membrane 4 is covered on the opening 31. With the above structural arrangement, the blood sample is drawn into the sample inlet channel by utilizing the hydrophilicity of the hydrophilic membrane 4 and the siphon effect of the sample inlet channel.

[0047] Furthermore, at least a portion of each of the plurality of electrodes is located within the sample injection channel, and the plurality of electrodes includes a first working electrode 22, a second working electrode 23, and a reference electrode 24. With the above structural arrangement, the first working electrode 22 and the reference electrode 24 form a current loop for detecting uric acid; the second working electrode 23 and the reference electrode 24 form a current loop for detecting blood glucose.

[0048] Furthermore, the first working electrode 22 is provided with an enzyme layer 221, which is located within the sample injection channel; the enzyme in the enzyme layer 221 is an enzyme that reacts with uric acid. This structural arrangement helps to improve detection speed and accuracy.

[0049] Furthermore, the plurality of electrodes also includes an HCT electrode 21 and a saturation detection electrode 25.

[0050] The HCT electrode 21 can be reused as both a background electrode and an impedance measurement electrode. When used as a background electrode, a weak DC excitation voltage is applied to this electrode relative to the reference electrode 24, allowing the measurement of a weak current, which is the background current of the blood sample. The magnitude of this background current reflects the purity of the blood sample. When used as an impedance measurement electrode, the sample impedance relative to the working electrode is measured using AC excitation. The proportion of red blood cells in the blood sample is then obtained through algorithmic fitting of the measurement results, effectively avoiding interference from hematocrit (HCT) and improving the accuracy of the test strip detection. The saturation judgment electrode 25 is used to determine whether the blood sample is saturated. When the blood sample flows into the contact surface of this electrode, there will be a significant step change in impedance between this electrode and the HCT electrode 21. By detecting the impedance change in this circuit, it is confirmed whether the blood sample has been fully absorbed.

[0051] Furthermore, the HCT electrode 21, the first working electrode 22, the second working electrode 23, the reference electrode 24, and the saturation determination electrode 25 located in the sample injection channel are arranged sequentially from the outside to the inside along the sample injection channel.

[0052] With the above structural arrangement, the fullness determination electrode 25 is located at the innermost position of the sample injection channel. The fullness determination electrode 25 and the HCT electrode 21 form a current loop and are also used for fullness determination. Only when the blood sample basically covers the sample injection channel can it touch the fullness determination electrode 25 and trigger the instrument to start detection. This effectively avoids the impact of insufficient sample intake on the detection results, thereby improving the detection accuracy.

[0053] When using the automatic coding dual-function test strip of this utility model, the test strip is inserted into the testing instrument. Multiple detection terminals of the instrument are respectively connected to the first coding electrode 111, the second coding electrode 121, the verification code 14, and the power-on electrode 13. The power-on electrode 13 connects the power-on circuit of the testing instrument, enabling it to start working. The instrument automatically identifies the first digital coding signals generated by the multiple first coding electrodes 111 in the first coding area 11 to perform coding for uric acid detection. The instrument automatically identifies the second digital coding signals generated by the multiple second coding electrodes 121 in the second coding area 12 to perform coding for blood glucose detection. The instrument automatically identifies the verification code 14 to verify whether the first and second digital coding signals are correct. If the verification result is correct, it prompts to start blood drop testing. The blood sample is added from the inlet of the sampling channel. Under the hydrophilicity of the hydrophilic membrane 4 and the siphon effect of the sampling channel, the blood sample flows into the sampling channel until it contacts the full-absorption judgment electrode 25. The testing instrument then begins to detect uric acid and blood glucose in the blood sample.

[0054] The above description is only a preferred embodiment of the present utility model. Therefore, all equivalent changes or modifications made to the structure, features and principles described in the claims of the present utility model patent application are included in the scope of the present utility model patent application.

Claims

1. A dual-function test strip with automatic coding, comprising a substrate (1), characterized in that, The substrate (1) is provided with a first coding area (11) and a second coding area (12). The first coding area (11) has a plurality of first coding electrodes (111). The first coding area (11) generates a first digital coding signal for the detection instrument to perform coding on the detection of the first index. The second coding area (12) has multiple second coding electrodes (121), and the second coding area (12) generates a second digital coding signal for the detection instrument to adjust the code for the detection of the second index.

2. The dual-function test strip with automatic coding according to claim 1, characterized in that, The first encoding electrode (111) and the second encoding electrode (121) are both binary encoding electrodes, and each binary encoding electrode is independently configured as a pass or a break structure.

3. The dual-function test strip with automatic coding according to claim 1, characterized in that, The substrate (1) is also provided with a power-on electrode (13).

4. The dual-function test strip with automatic coding according to claim 1, characterized in that, The substrate (1) is also provided with a check code (14).

5. The dual-function test strip with automatic coding according to claim 1, characterized in that, The first encoding area (11) is disposed on the top surface of the substrate (1), and the second encoding area (12) is disposed on the bottom surface of the substrate (1).

6. The dual-function test strip with automatic coding according to claim 1, characterized in that, The substrate (1) is further provided with an electrode layer (2), which includes a plurality of electrodes; The electrode layer (2) is covered with an insulating double-sided adhesive layer (3), and the insulating double-sided adhesive layer (3) has an opening (31). The substrate (1) and the opening (31) form a sample injection channel, and the opening (31) is covered with a hydrophilic film (4).

7. The dual-function test strip with automatic coding according to claim 6, characterized in that, At least a portion of each of the plurality of electrodes is located within the sample inlet channel, and the plurality of electrodes includes a first working electrode (22), a second working electrode (23), and a reference electrode (24).

8. The dual-function test strip with automatic coding according to claim 7, characterized in that, The first working electrode (22) is provided with an enzyme layer (221), which is located in the sample injection channel.

9. The dual-function test strip with automatic coding according to claim 7, characterized in that, The plurality of electrodes also includes an HCT electrode (21) and a saturation detection electrode (25).

10. The dual-function test strip with automatic coding according to claim 9, characterized in that, The HCT electrode (21), the first working electrode (22), the second working electrode (23), the reference electrode (24), and the saturation judgment electrode (25) located in the injection channel are arranged sequentially from the outside to the inside along the injection channel.

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