Testing method and system for sensor

Abstract

Provided in the present disclosure are a testing method and system for a sensor. The testing method comprises: preparing a test container that contains a test solution, wherein the test solution comprises an analyte; continuously introducing a predetermined gas comprising a predetermined concentration of a target substance into the test solution; and measuring the concentration of the target substance in the test solution, and when the concentration of the target substance in the test solution is within a predetermined range, testing a sensor that is at least partially located in the test solution, wherein the sensor is a predetermined distance away from a gas inflow point at which the predetermined gas enters the test solution, and during the testing process of the sensor, the predetermined gas is continuously introduced into the test solution, the testing of the sensor comprising measuring the concentration of the analyte by means of the sensor, and generating a signal related to the concentration of the analyte. The present disclosure can provide a simple and convenient testing method and system for a sensor.

Description

Sensor testing methods and testing systems Technical Field

[0001] This disclosure relates to the field of new materials-related services, specifically to a testing method and system for a sensor. Background Technology

[0002] Biosensors are analytical devices that tightly integrate biological materials, bio-derived materials, or biomimetic materials with physicochemical sensors or sensing microsystems that are optical, electrochemical, temperature, piezoelectric, magnetic, or micromechanical. They are typically used to rapidly detect certain specific chemical substances in the human body, such as glucose, ketones, and uric acid.

[0003] During the research and development and production process, it is usually necessary to test the performance of biosensors. Taking glucose sensors as an example, they typically need to be placed in a test solution with a predetermined oxygen content to simulate the in vivo environment, or the glucose sensor's response performance to glucose needs to be tested under multiple conditions with different oxygen contents. In existing technologies, the container containing the test solution is usually placed in a sealed vacuum chamber (glove box), and oxygen is introduced into the chamber. The oxygen introduced into the chamber comes into contact with the test solution over time and gradually dissolves in the test solution. After maintaining this state for a certain period of time, the test solution reaches the predetermined oxygen content, at which point the glucose sensor is placed into the test solution for testing.

[0004] However, for ease of operation, the internal space of the vacuum operation chamber is usually large, requiring a large amount of gas to fill the entire internal space, resulting in high gas consumption. Furthermore, waiting for the oxygen in the internal space of the vacuum operation chamber to dissolve into the test liquid usually takes a long time, which affects the testing efficiency. Summary of the Invention

[0005] This disclosure was made in view of the above-mentioned state of the prior art, and its purpose is to provide a simple and quick method and system for testing sensors.

[0006] To this end, a first aspect of this disclosure provides a method for testing a sensor, comprising: preparing a test solution including an analyte; continuously introducing a predetermined gas comprising a predetermined concentration of a target substance, the target substance being water-soluble, into the test solution; measuring the concentration of the target substance in the test solution; and, when the concentration of the target substance in the test solution is within a predetermined range, testing a sensor at least partially located in the test solution, wherein the sensor is spaced at a predetermined distance from the inlet point of the predetermined gas entering the test solution, and during the testing of the sensor, the predetermined gas is continuously introduced into the test solution, wherein testing the sensor includes measuring the concentration of the analyte through the sensor and generating a signal related to the concentration of the analyte.

[0007] In the first aspect of this disclosure, directly introducing a predetermined gas containing the target substance into the test solution helps the target substance dissolve rapidly in the test solution, thereby helping the concentration of the target substance in the test solution to quickly reach a predetermined range, which helps improve testing efficiency. Furthermore, the direct gas introduction method in this disclosure consumes less gas compared to the method of introducing gas into the internal space of a vacuum chamber. The bubbles generated during gas introduction accelerate molecular diffusion within the test solution, helping the target substance to be uniformly dispersed in the test solution. Continuous gas introduction during sensor testing helps maintain the concentration of the target substance in the test solution within a predetermined range. Moreover, this invention does not have special requirements for the concentration of the target substance in the external environment of the test container, and can be performed in ordinary environments, making it easier to implement. By setting the sensor and the gas inlet point at a predetermined distance, interference from bubbles generated during the gas inlet process on the sensor's operation can be reduced. Therefore, a simple and rapid sensor testing method can be provided.

[0008] In the testing method according to the first aspect of this disclosure, optionally, the sensor is coupled to electronic components to form a monitoring device applicable to the host to monitor the analyte, and then the sensor is at least partially immersed in the test solution for testing. In this case, the sensor in the monitoring device can be tested, further simulating the performance of the sensor in the monitoring device during actual use, and it helps to simplify the structure of the testing system, eliminating the need for additional electrical connection clamps for holding / supporting the sensor.

[0009] In the testing method according to the first aspect of this disclosure, optionally, the monitoring device is completely immersed in the test solution for testing. In this case, on the one hand, in addition to testing the performance of the sensor, it is also possible to test the relevant performance of the monitoring device (e.g., waterproof performance); on the other hand, it helps to simplify the structure of the testing system, eliminating the need for additional clamps for holding / supporting the monitoring device.

[0010] In the testing method according to the first aspect of this disclosure, optionally, the target substance is oxygen, and the concentration of the target substance is within a predetermined range of 0% to 100%. Thus, the sensor can be tested under conditions where the test solution has a predetermined oxygen content.

[0011] In the testing method according to the first aspect of this disclosure, optionally, the gas inlet point is located near the bottom of the test solution. In this case, the introduced gas moves from the bottom to the top of the test solution, which can help to achieve uniform mixing of the target substance and the test solution.

[0012] In the testing method according to the first aspect of this disclosure, optionally, when measuring the concentration of the target substance in the test solution, the concentration at multiple sites in the test solution is measured, and based on the concentration at the multiple sites, it is determined whether the concentration of the target substance in the test solution is within a predetermined range. This helps to improve the accuracy of the test results.

[0013] In the testing method according to the first aspect of this disclosure, optionally, when testing the sensor, the aeration rate of the predetermined gas introduced into the test solution is consistent. In this case, the effect of the bubbles generated during aeration on the test sensor is also almost consistent, which can help reduce errors and improve the accuracy of the test results.

[0014] In the testing method according to the first aspect of this disclosure, optionally, a first speed is used for introducing the predetermined gas into the test solution when the concentration of the target substance in the test solution is not within the predetermined range, and a second speed is used for introducing the predetermined gas into the test solution when testing the sensor, wherein the first speed is greater than the second speed. In this case, it is possible to help the target substance in the test solution quickly reach the predetermined range during the initial aeration, and the reduced speed during sensor testing can reduce the number of bubbles generated, thereby reducing the impact of bubbles on the sensor.

[0015] In the testing method according to the first aspect of this disclosure, optionally, when the sensor needs to be tested multiple times under conditions where the concentration of the target substance is within multiple different predetermined ranges, after one test, the sensor is not removed, and the predetermined gas corresponding to the next test is directly introduced into the test solution. In this case, the testing procedure can be simplified and the testing efficiency improved.

[0016] In the testing method according to the first aspect of this disclosure, optionally, when performing the multiple tests, a relatively low concentration of the predetermined gas is first introduced for testing, followed by a relatively high concentration of the predetermined gas for testing. In this case, the testing procedure can be simplified and the testing efficiency improved.

[0017] In the test method according to the first aspect of this disclosure, optionally, the aeration rate of the predetermined gas introduced into the test solution is from 0.01 L / min to 0.5 L / min. In this case, selecting an appropriate aeration rate can minimize the impact of air bubbles on the sensor while improving test efficiency, thereby maximizing the accuracy of the measurement results while maintaining efficiency.

[0018] In the test method involved in the first aspect of this disclosure, optionally, the number of sensors is multiple, and the distance between each sensor and the air intake point is within a predetermined range.

[0019] A second aspect of this disclosure provides a test system for testing a sensor, comprising a test container, a gas supply device, a measuring instrument, and a receiving device. The test container has a containment space for accommodating a test solution and a sensor. The gas supply device is configured to introduce a predetermined gas into the test solution located in the containment space via a vent pipe. The predetermined gas includes a water-soluble target substance of a predetermined concentration. The outlet of the vent pipe is located below the liquid surface of the test solution. The sensor located in the containment space is spaced a predetermined distance from the outlet. The measuring instrument is configured to measure the concentration of the target substance in the test solution. When the concentration of the target substance in the test solution is within a predetermined range, the sensor, at least partially located in the test solution, is tested. The sensor generates a signal related to the concentration of the analyte. The receiving device is configured to be coupled to the sensor and to receive the signal generated by the sensor related to the concentration of the analyte.

[0020] In the test system according to the second aspect of this disclosure, optionally, the test container includes a main body having the receiving space and a cap detachably covering the main body, the vent pipe passing through the cap into the receiving space.

[0021] Optionally, the testing system according to the second aspect of this disclosure may further include a temperature regulating device configured to regulate the temperature of the test solution located in the containment space of the test container.

[0022] In the test system according to the second aspect of this disclosure, optionally, the number of test containers is multiple, and the gas supply device is connected to each test container and supplies gas to each test container.

[0023] According to this disclosure, a simple and quick method and system for testing sensors can be provided. Attached Figure Description

[0024] Figure 1 illustrates an application scenario of the biosensor involved in the examples of this disclosure.

[0025] Figure 2 is a schematic diagram illustrating the structure of the biosensor involved in the example of this disclosure.

[0026] Figure 3 is a flowchart illustrating the testing method involved in the example of this disclosure.

[0027] Figure 4 is a schematic diagram illustrating a first embodiment of testing a sensor according to an example of this disclosure.

[0028] Figure 5 is a schematic diagram illustrating a second embodiment of testing a sensor according to an example of this disclosure.

[0029] Figure 6 is a schematic diagram illustrating a third embodiment of testing a sensor according to an example of this disclosure.

[0030] Figure 7 is a schematic diagram illustrating the test system involved in the example of this disclosure.

[0031] Figure 8 is a schematic diagram illustrating the test container involved in the example of this disclosure.

[0032] Figure 9 is a schematic diagram of the current-time results of the sensor involved in the embodiments of this disclosure.

[0033] Figure 10 is a schematic diagram of the current-oxygen content results of the sensor involved in the embodiments of this disclosure.

[0034] Explanation of reference numerals in the attached figures: 1…sensor, 11…implanted part, 12…external part, 13…working electrode, 14…analyte enzyme sensing layer, 2…electronic component, 100…monitoring device, 3…clamp, 20…testing system, 21…testing container, 211…main body, 212…cap, 213…tracheal opening, 214…second opening, 22…gas supply device, 221…ventilation tube, 23…measuring instrument, 24…receiving device. Detailed Implementation

[0035] Hereinafter, preferred embodiments of the present disclosure will be described in detail with reference to the accompanying drawings. In the following description, the same reference numerals are used for the same components, and repeated descriptions are omitted. Furthermore, the drawings are merely schematic diagrams, and the proportions of the components or the shapes of the components may differ from actual figures.

[0036] It should be noted that the terms "comprising" and "having" and any variations thereof in this disclosure, such as a process, method, system, product, or device that includes or has a series of steps or units, are not necessarily limited to those steps or units that are explicitly listed, but may include or have other steps or units that are not explicitly listed or that are inherent to such processes, methods, products, or devices.

[0037] The first aspect of this disclosure relates to a testing method for a sensor, which can test the performance of the sensor. For example, it can test the sensor's response performance to an analyte. The analyte response performance refers to the sensor's ability to detect and respond to the analyte, and may include performance indicators such as the sensor's sensitivity, selectivity, and response time when detecting the analyte. The sensor testing method of this disclosure can be simply referred to as a testing method, or it can also be called a sensor detection method, a biosensor response testing method, a method for rapidly testing sensor response, etc. The sensor disclosed in this disclosure can also be called a biosensor or an analyte sensor.

[0038] The second aspect of this disclosure relates to a sensor testing system capable of testing the performance of sensors. The sensor testing system of this disclosure may be simply referred to as a "test system," or a testing device, or a sensor testing device, etc. The testing system of this disclosure can be used in conjunction with the testing methods described in the first aspect of this disclosure to test sensors, or it can be used with other compatible testing methods to test sensors.

[0039] The test method for the sensor involved in this disclosure (hereinafter referred to as the test method) will be described below with reference to the accompanying drawings. For ease of understanding, the application of the sensor will be briefly described first.

[0040] Figure 1 is an application scenario diagram illustrating the biosensor 1 involved in the present disclosure. Figure 2 is a structural schematic diagram illustrating the biosensor 1 involved in the present disclosure.

[0041] In some examples, sensor 1 may be coupled to electronic component 2 to form monitoring device 100 (see Figure 1). Monitoring device 100 may be applied to a host, with sensor 1 at least partially located subcutaneously in contact with the host's bodily fluids to monitor analytes within the host. In some examples, sensor 1 may include an implantable portion 11 implantable within the host and an external portion 12 located outside the body (see Figure 2). The implantable portion 11 may contact the analyte within the host to generate a signal associated with the analyte concentration, and the external portion 12 may be electrically connected to electronic component 2 to transmit the analyte signal to electronic component 2.

[0042] In some examples, sensor 1 may include a working electrode 13 (see Figure 2). The working electrode 13 can be used to detect analytes. In some examples, sensor 1 may include an analyte enzyme sensing layer 14 disposed on the working electrode 13 (see Figure 2). Thus, when sensor 1 comes into contact with a test solution containing the analyte, it can generate an electrical signal related to the analyte concentration. For example, a glucose sensor 1 may have a glucose enzyme sensing layer 14 disposed on its working electrode 13. This allows for the monitoring of glucose levels.

[0043] Figure 3 is a flowchart illustrating the testing method involved in the example of this disclosure. Figure 4 is a schematic diagram illustrating a first embodiment of testing sensor 1 involved in the example of this disclosure.

[0044] In some examples, the testing method may include: preparing a test solution (step S1); continuously introducing a predetermined gas into the test solution (step S2); and testing the sensor 1, which is at least partially located in the test solution (step S3) (see Figure 3). In this case, directly introducing the predetermined gas into the test solution helps to quickly obtain the desired test solution, improves the efficiency of testing the sensor 1, and the direct gas introduction scheme in this disclosure consumes less gas compared to the scheme of introducing gas into the internal space of the vacuum operating chamber; furthermore, the present invention does not have special requirements on the concentration of the target substance in the external environment of the test container 21, can be carried out in a normal environment, and is more convenient to implement.

[0045] In some examples, the test solution may include an analyte. Sensor 1 can measure the concentration of the analyte and generate a signal related to the concentration of the analyte. In some examples, the analyte in the test solution may have a predetermined concentration. Therefore, it is possible to test the response performance of sensor 1 to a predetermined concentration of analyte.

[0046] In this disclosure, the analyte can be one or more of glucose, acetylcholine, amylase, bilirubin, cholesterol, human chorionic gonadotropin, creatine kinase, creatine, creatine anhydride, DNA, fructosamine, glutamine, hormones, ketone bodies, lactate, oxygen, peroxides, prostate-specific antigen, prothrombin, RNA, thyroid-stimulating hormone, and troponin. This is merely illustrative; the analyte can also be other substances not shown. In this disclosure, the test method is described in detail using glucose as the analyte.

[0047] In some examples, the composition of the test solution can be set based on the actual application environment of sensor 1. This helps to obtain test results that closely approximate the actual application environment. For example, when testing sensor 1, which is intended to detect glucose in human tissue fluid, the test solution can be a buffer solution containing a predetermined concentration of analyte. In some examples, the test solution can be a phosphate buffer solution containing a predetermined concentration of glucose. In this case, the composition of the test solution is close to that of human tissue fluid, which can simulate the environment in which sensor 1 detects glucose in human tissue fluid during in vitro testing, thereby obtaining test results that closely approximate the in vivo environment; and the use of a buffer solution can maintain pH stability, thus providing a stable liquid phase environment for measuring sensor 1.

[0048] In some examples, the analyte concentration in the test solution can range from 0.1 mmol / L to 30 mmol / L. For instance, the analyte concentration in the test solution can be 0.1 mmol / L, 1 mmol / L, 3 mmol / L, 5 mmol / L, 7 mmol / L, 8 mmol / L, 10 mmol / L, 11 mmol / L, 13 mmol / L, 15 mmol / L, 18 mmol / L, 20 mmol / L, 22 mmol / L, 25 mmol / L, 27 mmol / L, 28 mmol / L, 29 mmol / L, or 30 mmol / L. The analyte concentration in the test solution can be selected according to actual needs. For example, when it is necessary to simulate the glucose concentration in human body fluids, the glucose concentration in the test solution can be set to be close to that in human body fluids.

[0049] In some examples, the test solution may include a buffer solution. This helps maintain the pH stability of the test solution, providing a stable liquid phase environment, thereby contributing to more accurate test results. In some examples, the test solution may be a salt solution containing the analyte. For example, the test solution may be a phosphate solution containing the analyte. In some examples, the buffer solution may include sodium dihydrogen phosphate, disodium hydrogen phosphate, and / or sodium chloride, etc.

[0050] In some examples, the pH of the test solution can be between 5 and 8. For example, the pH of the test solution can be 5, 5.5, 6, 6.5, 7, 7.5, or 8. In some examples, preferably, the pH of the test solution can be between 7 and 7.5.

[0051] In some examples, the response performance of sensor 1 to the analyte can be measured under preset conditions. These preset conditions can be set based on the actual application environment of sensor 1. In some examples, the preset conditions may include a preset temperature range, a preset target substance concentration, a preset analyte concentration, etc. For example, when the analyte is glucose, since the oxygen content in human tissue fluid is low, a hypoxic environment can be constructed to simulate the internal environment of the human body, and the response performance of sensor 1 to the analyte under this hypoxic environment can be measured.

[0052] In some examples, the response performance of sensor 1 to the analyte can be measured under conditions of a predetermined target substance concentration. In some examples, the response performance of sensor 1 to the analyte can be measured under conditions of different target substance concentrations.

[0053] In some examples, in step S1, the test solution can be placed in the test container 21. That is, the test container 21 can contain the test solution.

[0054] In some examples, as described above, a predetermined gas may be introduced into the test solution in step S2. In some examples, the predetermined gas may include a target substance in step S2. The target substance may be water-soluble. In this case, when the predetermined gas containing the target substance is introduced into the test solution, the target substance can dissolve in the test solution, forming a test solution containing the target substance. Directly introducing the predetermined gas containing the target substance into the test solution can help the target substance dissolve rapidly in the test solution, thereby helping the concentration of the target substance in the test solution to quickly reach a predetermined range. Furthermore, the bubbles generated during gas introduction can accelerate molecular diffusion within the test solution, helping the target substance to be uniformly dispersed in the test solution.

[0055] In some examples, the target substance can be oxygen. This allows sensor 1 to be tested under conditions where the test solution has a predetermined oxygen content. In some examples, the predetermined gas can also be composed of the target substance.

[0056] In some examples, the predetermined gas may include the target substance and an inert gas. In some examples, the predetermined gas may consist of the target substance and an inert gas. In some examples, the inert gas may be nitrogen, argon, or helium.

[0057] In some examples, the target substance in the predetermined gas may have a predetermined concentration (hereinafter referred to as the gas phase concentration). This helps to ensure that the concentration of the target substance in the test solution (hereinafter referred to as the liquid phase concentration) is within a predetermined range. In this disclosure, the predetermined range can be a range value, whereby the liquid phase concentration of the target substance is considered to be within the predetermined range when it is equal to any value within the predetermined range.

[0058] In some examples, the gas phase concentration can range from 1% to 30%. For example, the gas phase concentration can be 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, or 30%.

[0059] In some examples, the predetermined range of the concentration of the target substance in the test solution can be 0% to 100%. That is, the predetermined liquid phase concentration of the target substance can be 0% to 100%. In some examples, the concentration of the target substance in the test solution can be set according to different needs. For example, when it is necessary to test the performance of sensor 1 in an oxygen-free environment, the predetermined liquid phase concentration can be set to 0%. At this time, the oxygen concentration in the predetermined gas can be 0%. By continuously introducing oxygen-free gas into the test solution, any oxygen that may be present in the test solution can be gradually removed, eventually making the test solution oxygen-free. At this point, sensor 1 can be measured. As another example, when it is necessary to test the performance of sensor 1 under multiple different liquid phase concentration conditions, multiple different predetermined liquid phase concentrations can be set.

[0060] In some examples, for glucose sensor 1, when it is necessary to test the performance of sensor 1 in a hypoxic environment inside the human body, the predetermined liquid phase concentration can be set to 1% to 5%.

[0061] In some examples, the gas phase concentration may not be less than the predetermined liquid phase concentration. This helps to bring the liquid phase concentration of the target substance within the predetermined liquid phase concentration range. In other examples, the gas phase concentration may be greater than the predetermined liquid phase concentration. This helps to rapidly bring the concentration of the target substance in the test solution within the predetermined liquid phase concentration range.

[0062] In some examples, the gas phase concentration can be within a predetermined range of liquid phase concentration. In other words, the gas phase concentration can be equal to any value within the predetermined range of liquid phase concentration. In this case, when the predetermined gas is continuously introduced into the test solution, it is possible to prevent the liquid phase concentration from continuing to rise beyond the predetermined range after it has already been within it, thereby helping to maintain the liquid phase concentration within the predetermined range.

[0063] In some examples, the gas phase concentration can be set in a gradient. For instance, the initial gas phase concentration when a predetermined gas is introduced into the test solution can be higher than the later gas phase concentration. In this case, it helps to quickly bring the initial liquid phase concentration of the target substance to within the predetermined liquid phase concentration range. Alternatively, in some examples, the initial gas phase concentration when a predetermined gas is introduced into the test solution can be higher than the predetermined liquid phase concentration, while the later gas phase concentration can be within the predetermined liquid phase concentration range. In this case, it helps to quickly bring the initial liquid phase concentration of the target substance to within the predetermined liquid phase concentration range, and maintain the liquid phase concentration within the predetermined liquid phase concentration range as gas continues to be introduced later.

[0064] In this disclosure, the location where the predetermined gas is introduced into the test solution is referred to as the gas inlet point. In some examples, the gas inlet point may be close to the bottom of the test solution. In this case, the introduced gas can move upward from the bottom of the test solution, which helps to prolong the contact time between the target substance in the gas and the test solution, thereby facilitating the uniform mixing of the target substance and the test solution.

[0065] As mentioned above, in step S3, sensor 1, which is at least partially located in the test solution, can be tested. That is, sensor 1 can be at least partially placed in the test solution to test sensor 1.

[0066] In some examples, the liquid phase concentration of the target substance in the test solution can be measured before sensor 1 is placed in the test solution. In some examples, sensor 1 can be tested when the liquid phase concentration of the target substance is within a predetermined range. That is, sensor 1 can be placed in the test solution for testing after the liquid phase concentration of the target substance has been confirmed.

[0067] In some examples, the liquid-phase concentration of the target substance in the test solution can be continuously monitored. For instance, a dissolved oxygen meter can be used to continuously monitor the oxygen content in the test solution. In this case, being able to perform the test after the liquid-phase concentration of the target substance has stabilized helps improve the accuracy of the test.

[0068] In some examples, when measuring the concentration of a target substance in a test solution, the concentration at multiple sites can be measured, and the concentration at these multiple sites can be used to determine whether the concentration of the target substance in the test solution is within a predetermined range. This helps improve the accuracy of the test results. In some examples, the concentration determination based on multiple sites can be achieved by taking the average concentration of multiple sites and judging whether the average value is within a predetermined range. In some examples, when measuring the concentration at multiple sites in the test solution, locations at different depths can be selected for testing. This facilitates obtaining a more accurate concentration.

[0069] In some examples, sensor 1 can be spaced a predetermined distance from the inlet point where the predetermined gas enters the test solution. As shown in Figure 4, sensor 1 can be spaced a predetermined distance from the inlet point P. In this case, the interference of air bubbles generated during the gas intake process on the operation of sensor 1 can be reduced, which helps to improve the accuracy of the measurement results.

[0070] In some examples, the predetermined distance between sensor 1 and the air intake point may be no less than 1 cm. In some examples, the predetermined distance between sensor 1 and the air intake point may be no less than 2 cm. In some examples, the predetermined distance between sensor 1 and the air intake point may be no less than 3 cm. In some examples, the predetermined distance between sensor 1 and the air intake point may be no less than 4 cm. In some examples, the predetermined distance between sensor 1 and the air intake point may be no less than 5 cm. In some examples, the predetermined distance between sensor 1 and the air intake point may be 1 cm to 20 cm. For example, in some examples, the predetermined distance between sensor 1 and the air intake point may be 1 cm, 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, 10 cm, 11 cm, 12 cm, 13 cm, 14 cm, 15 cm, 16 cm, 17 cm, 18 cm, 19 cm, or 20 cm. In some examples, the predetermined distance between sensor 1 and the air intake point may be 1 cm to 10 cm.

[0071] In some examples, the performance of multiple sensors 1 can be tested simultaneously. In some examples, the distance between each sensor 1 and the air inlet point can be within a predetermined range. This helps reduce interference from air bubbles on the operation of each sensor 1. In some examples, the distance between each sensor 1 and the air inlet point can be within the range of 1cm-20cm. In some examples, the distance between each sensor 1 and the air inlet point can be the same or different. In examples where the distance between each sensor 1 and the air inlet point is the same, it can help improve the measurement consistency of the batch of sensors 1. In some examples, the air inlet point can be set at the center (or bottom center) of the test solution, and then each sensor 1 can be arranged around the air inlet point. This makes it easier to make the distance between each sensor 1 and the air inlet point the same. It is understood that in actual testing environments, due to the limitations of objective conditions, the distance between each sensor 1 and the air inlet point may not be completely precise; it only needs to be approximately the same (e.g., the difference between each distance does not exceed 0.5cm).

[0072] In some examples, a predetermined gas can be continuously introduced into the test solution during the testing of the sensor 1. In this case, continuous gas supply during the testing of the sensor 1 helps maintain the concentration of the target substance in the test solution within a predetermined range; furthermore, compared to a method that stops gas supply during testing, the present invention does not consider the risk that stopping gas supply for a certain period of time may cause gas to escape, resulting in a decrease in the concentration of the target substance below the predetermined range, thereby limiting the testable time of the sensor 1.

[0073] In some examples, ventilation can be stopped during the testing of sensor 1. In this case, interference from air bubbles that may be generated during ventilation can be reduced.

[0074] In some examples, when testing sensor 1, the aeration rate of the predetermined gas introduced into the test solution can be consistent. In other words, the flow rate of the predetermined gas into the test solution can be constant during testing. In this case, the effect of the bubbles generated during aeration on the test sensor 1 is almost consistent, which helps to reduce errors and improve the accuracy of the test results.

[0075] The first velocity is defined as the rate at which a predetermined gas is introduced into the test solution when the concentration of the target substance in the test solution is not within a predetermined range, and the second velocity is defined as the rate at which the predetermined gas is introduced into the test solution when testing sensor 1. In some examples, the first velocity may be greater than the second velocity. In this case, the first velocity helps the target substance in the test solution to quickly reach the predetermined range during the initial aeration, while the reduced velocity during testing of sensor 1 reduces the number of bubbles generated and decreases the impact of bubbles on sensor 1.

[0076] In some examples, the aeration rate of the predetermined gas introduced into the test solution can be from 0.01 L / min to 0.5 L / min. For example, the aeration rate can be 0.01 L / min, 0.05 L / min, 0.1 L / min, 0.15 L / min, 0.2 L / min, 0.25 L / min, 0.3 L / min, 0.35 L / min, 0.4 L / min, 0.45 L / min, or 0.5 L / min. In this case, selecting an appropriate aeration rate can minimize the impact of air bubbles on sensor 1 while improving testing efficiency, thereby maximizing the accuracy of the measurement results while maintaining efficiency.

[0077] In some examples, the aeration time for introducing a predetermined gas into the test solution before testing sensor 1 can be from 0.01 h to 1 h. For example, the aeration time can be 0.01 h, 0.05 h, 0.1 h, 0.2 h, 0.25 h, 0.3 h, 0.4 h, 0.5 h, 0.6 h, 0.7 h, 0.75 h, 0.8 h, 0.9 h, or 1 h. In some examples, preferably, the aeration time can be from 0.1 h to 0.5 h. This helps the target substance in the test solution reach a predetermined concentration.

[0078] In some examples, as previously described, testing the sensor 1 may include measuring the concentration of the analyte using the sensor 1 and generating a signal related to the concentration of the analyte. This allows for the detection of the sensor 1's response performance to the analyte under predetermined conditions.

[0079] In some examples, a clamp 3 can be used to hold the sensor 1, placing the sensor 1 at least partially in the test solution for testing. When the clamp 3 holds the sensor 1, the sensor 1 can be electrically connected to a signal receiving device, allowing the signal detected by the sensor 1 corresponding to the analyte concentration to be received on the signal receiving device.

[0080] In some examples, as previously shown, sensor 1 can be coupled to electronic component 2 to form monitoring device 100. In some examples, sensor 1 can be coupled to electronic component 2 to form monitoring device 100 before testing sensor 1. In some examples, sensor 1, coupled to electronic component 2 to form monitoring device 100, can be at least partially submerged in a test solution during testing.

[0081] Figure 5 is a schematic diagram illustrating a second embodiment of testing sensor 1 according to an example of this disclosure. As shown in Figure 5, sensor 1 in monitoring device 100 may be partially located in the test solution. In this case, sensor 1 in monitoring device 100 can be tested, further simulating the performance of sensor 1 in monitoring device 100 during actual use, and it helps to simplify the structure of test system 20 without the need for a separate clamp 3 with electrical connection function for holding sensor 1.

[0082] In some examples, the monitoring device 100 can be completely immersed in the test solution for testing. Figure 6 is a schematic diagram illustrating a third embodiment of testing the sensor 1 according to an example of this disclosure. As shown in Figure 6, the monitoring device 100 can be completely immersed in the test solution. In this case, on the one hand, in addition to testing the performance of the sensor 1, it is also possible to test related performance of the monitoring device 100 (e.g., waterproof performance); on the other hand, it helps to simplify the structure of the test system 20, eliminating the need for a separate clamp 3 for holding the monitoring device 100 so that the electronic components 2 are partially outside the test solution.

[0083] In some examples, a predetermined voltage can be applied to sensor 1 during testing. This predetermined voltage can be associated with an electrochemical reaction. This helps to induce an electrochemical reaction upon contact between sensor 1 and the analyte, generating a signal associated with the analyte concentration. The value of the predetermined voltage can be set based on the operating voltage of sensor 1. For example, when the operating voltage of a glucose sensor 1 is in the range of -100mV to 200mV, the predetermined voltage can be selected from any value between -100mV and 200mV. This helps to simulate the operating state of sensor 1 and obtain more accurate measurement results. In some examples, preferably, the predetermined voltage is consistent with the actual operating voltage of sensor 1. In some examples, the voltage can be applied to sensor 1 through a conductive clamp 3. In examples where sensor 1 and electronic component 2 are assembled into a monitoring device 100 before testing, the voltage can be applied to sensor 1 through electronic component 2.

[0084] In some examples, multiple monitoring devices 100 can be tested. Specifically, when testing multiple sensors 1, each sensor 1 can be assembled with each electronic component 2 to form a monitoring device 100, and then the monitoring device 100 can be tested. In some examples, multiple monitoring devices 100 can all be completely immersed in the test solution.

[0085] In some examples, the temperature of the test solution can be adjusted to a predetermined range. This allows for testing the performance of sensor 1 under specific temperature conditions. For example, for glucose sensor 1, if it is necessary to test the performance of sensor 1 in an internal human environment, the temperature of the test solution can be heated to approximately 37°C. In some examples, a water bath can be used to heat the test container 21 to maintain the temperature of the test solution.

[0086] In some examples, sensor 1 can be tested multiple times under conditions where the concentration of the target substance is within multiple different predetermined ranges. In other examples, when multiple tests of sensor 1 are required under conditions where the concentration of the target substance is within multiple different predetermined ranges, after one test of sensor 1, sensor 1 can be left in place, and the predetermined gas corresponding to the next test can be directly introduced into the test solution. In this case, the testing procedure can be simplified, and testing efficiency improved.

[0087] In some examples, when conducting multiple tests, a relatively low concentration of a predetermined gas can be introduced first, followed by a relatively high concentration. This simplifies the testing process and improves efficiency.

[0088] As previously mentioned, this disclosure also provides a test system 20 for testing the performance of sensor 1. In some examples, the test system 20 can be used in conjunction with the aforementioned test method to test sensor 1. Hereinafter, the test system 20 will be described in detail using the test system 20 in conjunction with the test method as an example, and the parts already described in the aforementioned test method will not be repeated.

[0089] Figure 7 is a schematic diagram illustrating the test system 20 involved in the example of this disclosure.

[0090] In some examples, the test system 20 may include a test container 21 (see Figure 7). The test container 21 may contain a test solution. Specifically, the test container 21 may have a containment space for holding the test solution and the sensor 1.

[0091] In some examples, the test system 20 may include a gas supply device 22 (see Figure 7). The gas supply device 22 may be configured to introduce a predetermined gas into the test solution located in the containment space. In some examples, the gas supply device 22 may be connected to the test container 21. In some examples, the gas supply device 22 may include gas cylinders. In cases where the predetermined gas contains multiple components, in some examples, the gas cylinders may contain the predetermined gas. In other examples, gas cylinders containing each component may be provided, and the gases from each gas cylinder may be output in a predetermined ratio to form the predetermined gas, which is then provided to the test container 21. For example, when the predetermined gas includes oxygen and nitrogen, oxygen cylinders and nitrogen cylinders may be prepared separately, and oxygen and nitrogen may be output in a predetermined ratio for mixing to form the predetermined gas. In some examples, preferably, gas cylinders containing each component may be provided. In this case, it is convenient to adjust the content of each component in the predetermined gas, thereby facilitating its application in scenarios where the sensor 1 needs to be measured under different conditions.

[0092] In some examples, the gas supply device 22 can supply gas to the test container 21 via the vent pipe 221. In some examples, the outlet of the vent pipe 221 (i.e., the inlet point P of the aforementioned predetermined gas) can be located below the surface of the test solution. This facilitates the dissolution of the target substance in the predetermined gas into the test solution. In some examples, the outlet of the vent pipe 221 can be located at the bottom of the test solution. In this case, the inlet point of the predetermined gas into the test solution can be close to the bottom of the test solution, thereby promoting uniform mixing of the target substance and the test solution.

[0093] In some examples, the sensor 1 located in the containment space can be spaced a predetermined distance from the air outlet. In this case, the interference of air bubbles on the operation of sensor 1 can be reduced, improving the accuracy of the measurement results.

[0094] Figure 8 is a schematic diagram illustrating the test container 21 involved in the example of this disclosure.

[0095] In some examples, the test container 21 includes a main body 211 with a containment space and a cap 212 removably covering the main body 211. When the cap 212 is on the main body 211, the containment space is not completely sealed. In this case, the cap 212 reduces gas exchange between the test solution and air in the external environment, which helps reduce contamination and improves the efficiency of the target substance dissolving in the test solution. Furthermore, the fact that the containment space is not completely sealed prevents excessive pressure differences between the inside and outside of the test container 21 caused by ventilation into the containment space.

[0096] In some examples, the area of ​​the region where the inside and outside of the test container 21 can be connected can be minimized as much as possible without affecting the pressure difference between the inside and outside of the test container 21. Here, "without affecting the pressure difference between the inside and outside of the test container 21" means that gas can still escape from the test container 21 during ventilation without causing an excessive pressure difference between the inside and outside. In this case, it helps to reduce gas exchange between the inside and outside, which helps to reduce contamination and also helps to maintain the internal space of the test container 21 and the concentration of the target substance in the test solution.

[0097] In some examples, the vent tube 221 can pass through the cap 212 into the receiving space. In other words, the cap 212 can have a vent opening 213 through which the vent tube 221 passes (see FIG. 8). In this disclosure, the vent opening 213 can also be referred to as the first opening. This facilitates ventilation into the receiving space when the cap 212 is placed over the body portion 211. In some examples, the cap 212 can include a rigid shell having a mechanical connection to the body portion 211. In some examples, the cap 212 can also be a flexible film that can cover the opening of the body portion 211 (such a flexible film can also be referred to as a sealing film). When the cap 212 is a flexible film, the vent tube 221 can be placed in the receiving space first, and then the flexible film can be used to cover the opening of the body portion 211 and the vent tube 221, thereby sealing the opening of the body portion 211 as much as possible. In some examples, the cap 212 can include a rigid shell and a flexible film. The ventilator 221 can be first inserted into the receiving space through the tracheal opening 213 of the rigid shell, and then the connection between the ventilator 221 and the tracheal opening 213 can be covered with a flexible film. In this case, the rigid shell can easily fix the position of the ventilator 221, and the flexible film can further reduce the permeable area at the connection.

[0098] In some examples, the sensor 1 can be placed in the test solution before the cap 212 is placed on the main body 211. In this case, compared to adding the sensor 1 after aeration and stabilization of the liquid phase concentration of the target substance, this method of placing the sensor 1 in advance avoids opening and closing the cap during aeration, which helps maintain the stability of the internal environment of the test container 21.

[0099] In some examples, the number of test containers 21 can be multiple. When testing multiple sensors 1, the multiple sensors 1 can be placed in the same test container 21, or each sensor 1 can be placed in a separate test container 21. In some examples, the test system 20 may include a splitter. The gas supply device 22 can be connected to each test container 21 through the splitter. In this case, it can help improve the testing efficiency of testing multiple sensors 1 simultaneously. In some examples, the type of splitter can be selected based on actual needs. For example, the splitter can be 2, 3, 4, 5, 6, 7, or 8 splitters. In some examples, the test system 20 may also include a multi-port pipe. The gas supply device 22 can be connected to each test container 21 through the multi-port pipe.

[0100] In some examples, the volume of the test container 21 can be set according to the volume of the object being measured and the test solution. Specifically, the volume of the test container 21 is at least greater than the sum of the volumes of the object being measured and the test solution. Thus, the test container 21 can hold both the test solution and the object being measured.

[0101] In some examples, there can be multiple inlet points for the predetermined gas to enter the test solution. In other words, the test system 20 can have multiple inlet points for the predetermined gas to enter the test solution. In this case, having multiple inlet points can adapt to a test container 21 with a larger volume, making it easier for the target substance in the test solution in the test container 21 to quickly reach a predetermined concentration. In some examples, multiple inlet points can be provided by setting multiple vent pipes 221 connected to the test container 21. In this embodiment, the sensor 1 can be spaced at a predetermined distance from the nearest inlet point to reduce the interference of air bubbles on the sensor 1.

[0102] In some examples, during testing, the implanted portion 11 (i.e., the sensing portion) of sensor 1 may not contact the inner wall of the test container 21. This can help improve the accuracy of the measurement.

[0103] In some examples, the testing system 20 may include a measuring instrument 23 (see Figure 7). The measuring instrument 23 may be configured to measure the concentration of a target substance in the test solution. In this case, it is possible to determine whether the liquid phase concentration of the target substance is within a predetermined range based on the result of the measuring instrument 23, and decide whether to start measuring the sensor 1. In some examples, the measuring instrument 23 may be a dissolved oxygen measuring instrument 23. Thus, the oxygen content in the test solution can be measured. In some examples, the cap 212 may have a second opening 214 through which the probe of the dissolved oxygen measuring instrument 23 passes (see Figure 8). Thus, it is convenient to measure the liquid phase concentration of the target substance during aeration. In some examples, in a configuration where the sensor 1 or monitoring device 100 needs to be held by a clamp 3, the cap 212 may have a third opening through which the clamp 3 passes.

[0104] In some examples, the main body 211 of the test container 21 can be a three-necked flask. A cap 212 can be placed over the mouth of the three-necked flask. The three tubes of the three-necked flask can be an inlet tube, a measuring tube, and an outlet tube, respectively. A vent tube 221 can enter through the inlet tube and connect to the test solution, while gas can be discharged through the outlet tube. A measuring instrument 23 can be installed inside the measuring tube to measure the test solution inside the three-necked flask. Thus, a convenient test container 21 can be provided.

[0105] In some examples, the test system 20 may include a flow meter. The flow meter may be located at the gas supply device 22. This facilitates the monitoring and adjustment of the gas flow rate.

[0106] In some examples, the test system 20 may include a receiving device 24 (see Figure 7). The receiving device 24 may be configured to couple with the sensor 1 and receive a signal generated by the sensor 1 that relates to the concentration of the analyte. Thus, the receiving device 24 can receive the detection signal of the analyte from the sensor 1 and obtain measurement results. In some examples, the receiving device 24 may be an electronic component 2 that can be coupled with the sensor 1 to form a monitoring device 100. In some examples, the receiving device 24 may also be located outside the test container 21 and can receive signals emitted by the monitoring device 100. In some examples, the receiving device 24 may include an analysis unit. The analysis unit can perform data analysis on the signal generated by the sensor 1 to obtain test results. In some examples, the receiving device 24 may also be other external devices. In some examples where the sensor is held using a clamp 3, the clamp 3 may be connected to the receiving device 24.

[0107] In some examples, the test system 20 may include a temperature regulator. The temperature regulator can be used to regulate the temperature of the test solution. In some examples, the temperature regulator may be a water bath heating device. The test container 21 can be placed in the water bath heating device for heating. In this case, it helps to maintain the temperature of the test solution stably for a long time, thereby providing a stable test environment. In some examples, the temperature regulator may also be an ultrasonic heating device.

[0108] It should be noted that in some examples, the test method described above may not be used in conjunction with the test system 20 involved in this disclosure, and other devices capable of implementing the test method of this disclosure may be used to test the sensor 1.

[0109] In summary, according to this disclosure, a simple and quick testing method and testing system 20 for sensor 1 can be provided.

[0110] To further illustrate this disclosure, the testing methods provided by this disclosure will be described in detail below with reference to embodiments, and the beneficial effects achieved by this disclosure will be fully explained with reference to comparative examples.

[0111] It should be noted that, unless otherwise specified, the reagents and instruments used in the embodiments disclosed herein are all commercially available products.

[0112] [Example 1]

[0113] First, prepare the glucose sensor to be tested;

[0114] Prepare a phosphate test solution with a glucose concentration of 11.1 mmol / L and place it in a test container. Set the temperature of the water bath thermostat to 37°C and place the test container in the water bath thermostat for preheating until the temperature reaches 37±0.5°C. Then, place the prepared glucose sensor into the test solution.

[0115] Prepare the following five groups of gases to be tested: a: pure nitrogen, b: 1% oxygen, c: 5% oxygen, d: 10% oxygen, and e: air (21% oxygen). Connect the gas hoses, connect one end of the hose to the gas delivery pump, and immerse the other end below the test liquid. Insert the probe of the dissolved oxygen meter 1-2 cm into the surface of the test liquid without touching the sensor under test or the test container wall. Secure the hose and dissolved oxygen meter at the test container opening with sealing film and seal the container opening as much as possible. Continuously pass the gas a to be tested into the test liquid. Monitor the gas composition in the test liquid using the dissolved oxygen meter. When the gas composition reaches the preset value and the current stabilizes, record the current value 1. Replace with gas b, reconnect the hose, and monitor the gas composition in the solution using the dissolved oxygen meter. When the gas composition reaches the preset value and the current stabilizes, record the current value 2. Repeat this process for the sensor under the five gas conditions (a-e) and record the current values. Figure 9 is a schematic diagram of the current-time results of the sensor involved in this embodiment. Figure 10 is a schematic diagram of the current-oxygen content results of the sensor involved in the embodiments of this disclosure.

[0116] Referring to Figures 9 and 10, it can be seen that when testing gases with multiple different components is required, the testing method disclosed herein can quickly bring the oxygen concentration in the test solution to the preset value, and the measurement results are highly reliable.

[0117] Comparative experiment: Testing the sensor performance under 2% oxygen conditions

[0118] [Example 2]

[0119] Using an 8L gas cylinder, gas is simultaneously supplied to four test containers containing test solutions and monitoring devices. A predetermined gas containing 2% oxygen is continuously introduced into the four test containers. After about 10 minutes, the oxygen in the test solution reaches the preset value, and after about 1 minute, the current stabilizes. The gas consumption for one test of the sensors in the four test containers is approximately 0.8L.

[0120] [Comparative Example]

[0121] Prepare a test container containing the test solution and monitoring device, a water bath thermostat, and a vacuum glove box containing a dissolved oxygen meter. Connect a 40L gas cylinder to the vacuum glove box and continuously introduce a predetermined gas containing 2% oxygen into the vacuum glove box. After about 3.5 hours, the oxygen in the test solution reaches the preset value, and the current stabilizes after about 1 minute. During this process, the 40L gas cylinder was replaced once, and about 60L of gas was consumed when the oxygen concentration in the test solution reached the predetermined concentration.

[0122] It is evident that, compared to the comparative example, the test time of Example 2 is shorter and the gas consumption is lower, both of which are superior to the comparative example.

[0123] In summary, the testing method provided in this disclosure enables rapid testing of sensors with high efficiency and low resource consumption.

[0124] While the present disclosure has been specifically described above in conjunction with the accompanying drawings and examples, it is to be understood that the foregoing description does not limit the present disclosure in any way. Those skilled in the art can make modifications and variations to the present disclosure as needed without departing from its essential spirit and scope, and all such modifications and variations shall fall within the scope of the present disclosure.

Claims

1. A method for testing a sensor, characterized in that, include: Prepare a test solution, which includes the analyte; A predetermined gas comprising a target substance of a predetermined concentration, wherein the target substance is water-soluble, is continuously introduced into the test solution. The concentration of the target substance in the test solution is measured. When the concentration of the target substance in the test solution is within a predetermined range, a sensor at least partially located in the test solution is tested. The sensor is spaced a predetermined distance from the inlet point of the predetermined gas entering the test solution. During the testing of the sensor, the predetermined gas is continuously introduced into the test solution. The testing of the sensor includes measuring the concentration of the analyte through the sensor and generating a signal related to the concentration of the analyte.

2. The test method according to claim 1, characterized in that, The sensor is coupled to electronic components to form a monitoring device that can be applied to the host to monitor the analyte, and the sensor is then at least partially located in the test solution for testing.

3. The test method according to claim 2, characterized in that, The monitoring device is completely immersed in the test solution for testing.

4. The test method according to claim 1, characterized in that, The target substance is oxygen, and the concentration of the target substance in the test solution is within a predetermined range of 0% to 100%.

5. The test method according to claim 1, characterized in that, The air inlet is located near the bottom of the test solution.

6. The test method according to claim 1, characterized in that, When measuring the concentration of the target substance in the test solution, the concentration at multiple sites in the test solution is measured, and the concentration at the multiple sites is used to determine whether the concentration of the target substance in the test solution is within a predetermined range.

7. The test method according to claim 1, characterized in that, When testing the sensor, the gas is introduced into the test solution at a consistent rate.

8. The test method according to claim 1, characterized in that, The first speed is the rate at which the predetermined gas is introduced into the test solution when the concentration of the target substance in the test solution is not within the predetermined range, and the second speed is the rate at which the predetermined gas is introduced into the test solution when the sensor is being tested, wherein the first speed is greater than the second speed.

9. The test method according to claim 1, characterized in that, When the sensor needs to be tested multiple times under conditions where the concentration of the target substance is within multiple different predetermined ranges, after testing the sensor once, the sensor is not removed, and the predetermined gas corresponding to the next test is directly introduced into the test solution.

10. A testing system for testing sensors, characterized in that, Includes test containers, gas supply devices, measuring instruments, and receiving devices. The test container has a space to hold the test solution and the sensor. The gas supply device is configured to introduce a predetermined gas into the test solution located in the containment space via a vent pipe. The predetermined gas includes a water-soluble target substance of a predetermined concentration. The outlet of the vent pipe is located below the liquid surface of the test solution, and the sensor located in the containment space is spaced a predetermined distance from the outlet. The measuring instrument is configured to measure the concentration of the target substance in the test solution. When the concentration of the target substance in the test solution is within a predetermined range, the sensor, which is at least partially located in the test solution, is tested. The sensor generates a signal related to the concentration of the analyte. The receiving device is configured to be coupled to the sensor and to receive a signal generated by the sensor that is related to the concentration of the analyte.

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