Testing system and testing method for analyte sensor

Abstract

The invention discloses a testing system and a testing method for an analyte sensor. The testing system comprises a liquid storage device, a conveying device and a testing device, the liquid storage device comprises a regulating liquid storage mechanism and an analyte liquid storage mechanism; the testing device comprises a testing bin configured to contain testing liquid and a mounting seat, and the mounting seat is configured to fix an analyte sensor to be tested and enable a testing part of the analyte sensor to be immersed in the testing liquid; the conveying device is communicated with an inlet of the testing bin and conveys liquid of the analyte liquid storage mechanism and the adjusting liquid storage mechanism to the testing bin according to a preset formula to form testing liquid; in the testing process, the conveying device is configured to continuously convey liquid to the testing bin so that the testing liquid can test the analyte sensor in a flowing state. According to the present disclosure, the test system and the test method of the analyte sensor, which can continuously test and have high test efficiency, can be provided.

Description

Technical Field

[0001] The present invention relates to the field of biosensors, and in particular to a testing system and a testing method for an analyte sensor. Background Art

[0002] Biosensors are analytical devices that tightly integrate biomaterials, bio-derived materials, or biomimetic materials with optical, electrochemical, temperature, piezoelectric, magnetic, or micromechanical physicochemical sensors or sensing microsystems. They are typically used to rapidly detect specific chemicals in the human body, such as glucose, ketone bodies, uric acid, lactic acid, and amino acids, by monitoring changes in the concentration of specific chemicals to reflect physiological information of the human body. During the development and production of sensors, they are often tested. In vitro testing has become a common method for sensor testing due to its convenience and controllability.

[0003] Currently, in vitro testing of sensors is usually performed in an electrochemical workstation. Solutions containing analytes of different concentrations are prepared in a test container (such as a beaker) as test solutions, and the implanted part (test part) of the sensor is placed in the test solutions in turn to obtain different microcurrent data.

[0004] However, the above method is not convenient for continuous testing of the sensor; when it is necessary to replace the test solution with another concentration for testing, it is usually necessary to take out the sensor and replace the solution before testing, or to move the sensor to a test container containing the test solution of the next concentration. Such frequent replacement of the test solution / sensor can easily lead to reduced testing efficiency. Summary of the Invention

[0005] The present disclosure is made in view of the above-mentioned state of the prior art, and its object is to provide a testing system and a testing method for an analyte sensor.

[0006] To this end, a first aspect of the present disclosure provides a testing system for an analyte sensor, comprising a liquid storage device, a delivery device, and a testing device; the liquid storage device includes a regulating liquid storage mechanism for storing a regulating liquid for regulating the concentration of an analyte, and one or more independent analyte storage mechanisms; when there are multiple analyte storage mechanisms, each analyte storage mechanism is used to store a solution containing a different analyte; the testing device includes a testing chamber configured to hold a test liquid and a mounting seat, the test liquid being configured to flow into the testing chamber through an inlet of the testing chamber and out through an outlet of the testing chamber, the mounting seat being configured to secure the analyte sensor to be tested and immerse a testing portion of the analyte sensor in the test liquid; the delivery device is connected to the inlet of the testing chamber and delivers liquid from the analyte storage mechanism and the regulating liquid storage mechanism to the testing chamber to form the test liquid according to a predetermined formula, the predetermined formula being set according to the testing requirements of the analyte sensor; during the testing process, the delivery device is configured to continuously deliver liquid to the testing chamber so that the test liquid tests the analyte sensor in a flowing state.

[0007] In the first aspect of the present disclosure, the liquid of the analyte storage mechanism and the regulating liquid storage mechanism is transported to the test chamber by a conveying device to form a test liquid. During the test process, the conveying device continuously conveys liquid to the test chamber, so that the test liquid is in a flowing state to test the analyte sensor, which can more realistically simulate the physiological environment of the body fluid in the body in a flowing state. When it is necessary to adjust the test liquid condition in the test area (for example, adjust the test liquid concentration and / or adjust the analyte contained in the test liquid), the test liquid in the test chamber can be quickly switched by the conveying device to reach a predetermined component to facilitate testing, thereby improving test efficiency. In addition, in the example of setting up multiple storage mechanisms for storing different analyte solutions, it is easy to form a test liquid containing multiple analytes at the same time, so as to facilitate testing of sensors with such testing requirements (for example, multi-analyte sensors).

[0008] In the test system according to the first aspect of the present disclosure, the conditioning liquid may optionally be a liquid that does not contain the analyte. In this case, the analyte content in the test liquid may be adjusted by controlling the volumes of the conditioning liquid and the solution in the analyte reservoir (also referred to as the analyte solution) respectively input into the test chamber.

[0009] In the testing system according to the first aspect of the present disclosure, the delivery device optionally includes multiple delivery mechanisms, each of which is configured to deliver liquid from a different liquid reservoir to the testing chamber. In this case, by having the multiple delivery mechanisms deliver liquid from different liquid reservoirs, respectively, the concentration of the analyte in the testing fluid can be easily adjusted.

[0010] In the test system according to the first aspect of the present disclosure, the concentration of the analyte in the test fluid can optionally be adjusted by controlling the liquid flow rate in the delivery mechanism. In this case, by controlling the delivery speeds of the different delivery mechanisms, the liquid supply speeds in the different liquid storage mechanisms can be adjusted, thereby facilitating dynamic adjustment of the analyte concentration in the test fluid and facilitating flexible and rapid adjustment of the analyte concentration in the test fluid.

[0011] In the testing system according to the first aspect of the present disclosure, the liquid storage device may optionally further include one or more interfering substance storage mechanisms, wherein each of the plurality of interfering substance storage mechanisms is configured to store a solution containing a different interfering substance. In this case, one or more interfering substances can be provided to test the effects of different interfering substances on the analyte sensor.

[0012] In the test system of the first aspect of the present disclosure, optionally, the test system satisfies at least one of the following conditions: the analyte includes at least one of glucose, lactate, ketone bodies, uric acid, and urea; and the interferor includes at least one of ascorbic acid, acetaminophen, ibuprofen, aspirin, hydroxyurea, mannose, xylose, and uric acid. In this case, multiple analyte sensors, such as glucose sensors, lactate sensors, and glucose / ketone body dual sensors, can be tested, and the effects of interfering substances such as ascorbic acid on analyte sensors can be tested.

[0013] In the testing system of the first aspect of the present disclosure, the plurality of delivery mechanisms may be configured to respectively collect liquids from different liquid storage mechanisms into a first conduit and into the testing chamber. In this case, different solutions may be introduced into the first conduit, mixed in the first conduit, and subsequently mixed into a test solution that enters the testing chamber.

[0014] In the testing system of the first aspect of the present disclosure, optionally, a ratio of the diameter of the testing chamber to the diameter of the first pipe is 0.5 to 2. In this case, the difference in diameter between the testing chamber and the first pipe is small, which can help ensure more uniform distribution of the test liquid at various locations in the testing chamber, thereby improving test accuracy.

[0015] In the test system involved in the first aspect of the present disclosure, optionally, the test system further includes at least one of the following: a temperature control device, an atmosphere adjustment device, and a control device; wherein the temperature control device is configured to adjust the temperature of the test liquid in the test device, the atmosphere adjustment device is configured to adjust the oxygen content of the test liquid in the test device, the control device is electrically connected to at least one of the conveying device, the temperature control device, and the atmosphere adjustment device, and the control device is configured to control the conveying device, the temperature control device, and / or the atmosphere adjustment device to adjust the analyte concentration, interfering substance concentration, temperature, and / or oxygen content in the test liquid according to the test requirements inputted. In this case, the effects of temperature changes (e.g., simulating human hypothermia) and oxygen content changes (e.g., simulating human hypoxia) on the analyte sensor can be tested.

[0016] The second aspect of the present disclosure provides a method for testing an analyte sensor, wherein the analyte sensor is tested using the analyte sensor testing system described in the first aspect of the present disclosure. The testing method comprises: securing the analyte sensor to be tested to a testing device; supplying a test fluid to the testing device according to input test requirements; and allowing the test fluid to flow to test the analyte sensor. The testing method of the second aspect of the present disclosure can facilitate continuous testing of the analyte sensor. Compared to existing technologies, it can reduce or avoid frequent changes of the test solution, thereby improving test efficiency and test stability.

[0017] According to the present disclosure, a testing system and a testing method for an analyte sensor that can perform continuous testing and has high testing efficiency can be provided. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 2 is a diagram showing an application scenario of the analyte sensor involved in the example of the present disclosure.

[0019] Figure 2 Schematic diagram showing the structure of the sensor component involved in the example of the present disclosure.

[0020] Figure 3 1 is a schematic diagram showing the structure of a test system of one example involved in the examples of the present disclosure.

[0021] Figure 4 It is a structural diagram showing another example of a test system involved in the examples of the present disclosure.

[0022] Figure 5 It shows Figure 4 A partial enlarged view of the test device.

[0023] Figure 6 It shows Figure 4 Schematic diagram of the test device.

[0024] Figure 7 It is a block diagram showing a test system involved in the examples of the present disclosure.

[0025] Figure 8 1 is a flow chart illustrating a method for testing an analyte sensor according to an example of the present disclosure.

[0026] Description of reference numerals:

[0027] 100…testing system, 10…liquid storage device, 11…analyte storage mechanism, 12…regulating liquid storage mechanism, 13…interferer storage mechanism, 20…delivery device, 21…first delivery mechanism, 22…second delivery mechanism, 23…third delivery mechanism, 25…first pipeline, 30…testing device, 31…mounting seat, 32…testing chamber, 40…temperature control device, 50…atmosphere control device, 60…control device; 800…analyte sensor, 810…sensing component, 820…electronic component, 811…implanted part, 812…in vitro part, 813…working electrode, 814…analyte enzyme sensing layer. DETAILED DESCRIPTION

[0028] The preferred embodiments of the present disclosure are described in detail below with reference to the accompanying drawings. In the following description, identical components are assigned identical reference numerals, and duplicate descriptions are omitted. In addition, the accompanying drawings are merely schematic, and the proportions of the dimensions of the components and the shapes of the components may differ from the actual ones.

[0029] It should be noted that the terms "including" and "having" and any variations thereof in the present invention, 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 clearly listed, but may include or have other steps or units that are not clearly listed or are inherent to these processes, methods, products or devices.

[0030] In addition, the subheadings and the like in the following description of the present invention are not intended to limit the content or scope of the present invention, but are merely provided as a guide for reading. Such subheadings should not be understood as dividing the content of the article, nor should the content under the subheadings be limited to the scope of the subheadings.

[0031] Sensors that continuously monitor various analytes are emerging. For example, sensors that continuously monitor blood glucose and ketone levels offer significant convenience for diabetics. Lactate sensors, which constantly monitor lactate levels, are gaining popularity among athletes and fitness enthusiasts. Sensor testing is often required during the development and production of sensors. In vitro testing, due to its convenience and controllability, has become a common method for sensor testing. Currently, in vitro testing of sensors is typically performed using electrochemical methods. Solutions containing varying concentrations of the analyte are prepared as test solutions, and the sensor's implanted portion (testing portion) is sequentially placed in the test solutions to obtain varying microcurrent data. However, these methods cannot continuously test the sensor and require frequent changes in the test solution, resulting in low test efficiency and, in turn, impacting test stability. Furthermore, current in vitro sensor testing fails to account for the effects of interferences, temperature fluctuations, and hypoxia on sensor signals under physiological conditions such as interfering substances. Therefore, it is necessary to develop a testing system that can simulate the continuous changes in analytes and the occurrence of interferences (interfering substances, temperature changes, and oxygen level fluctuations) in vitro to more accurately evaluate sensor performance, such as accuracy, interference immunity, and latency.

[0032] The present disclosure provides a testing system and method for an analyte sensor, which can be used to test the performance of an analyte sensor. For example, the analyte sensor's response performance to an analyte and its anti-interference performance can be tested. Analyte response performance refers to the sensor's ability to detect and respond to an analyte. Response performance can include performance indicators such as sensitivity, selectivity, and response time when detecting an analyte.

[0033] The analyte sensor disclosed herein may refer to a device for detecting or monitoring the concentration of an analyte, and may also be referred to as a biosensor, a physiological parameter sensor, a sensing probe, etc. The analyte may be a chemical substance in a host's body fluid. For example, the analyte may be one or more of glucose, urea, lactic acid, uric acid, acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase, creatine, creatinine, DNA, fructosamine, glucose, glutamine, growth hormone, hormone, ketone body, lactate, oxygen, peroxide, prostate-specific antigen, prothrombin, RNA, thyroid-stimulating hormone, or troponin. In addition, the analyte may also be a drug in a body fluid. For example, the test object may be digitoxin, digoxin, theophylline, warfarin, or an antibiotic (such as gentamicin, vancomycin, etc.).

[0034] The following describes the test system (sometimes referred to as the "test system") and test method (sometimes referred to as the "test method") of the analyte sensor disclosed herein, with reference to the accompanying drawings. For ease of understanding, the structure and application of the analyte sensor are briefly described.

[0035] Figure 1 is a diagram showing an application scenario of the analyte sensor 800 involved in the example of the present disclosure. Figure 2 Schematic diagram showing the structure of the sensor component 810 involved in the example of the present disclosure.

[0036] In some examples, the sensing assembly 810 can be coupled with the electronics assembly 820 to form the analyte sensor 800 (see Figure 1 ). The analyte sensor 800 can be applied to the host, and the sensing component 810 is at least partially located under the host's skin and in contact with the host's body fluids, thereby monitoring the analyte in the host's body. In some examples, the sensing component 810 can include an implantable portion 811 that can be implanted in the host's body, and an external portion 812 located outside the body (see Figure 2 The implantable portion 811 can contact an analyte in the host body to generate a signal associated with the analyte concentration, and the external portion 812 can be electrically connected to the electronic component 820 to transmit the analyte signal to the electronic component 820.

[0037] In some examples, the sensing assembly 810 may include a working electrode 813 (see Figure 2 ). The working electrode 813 can be used to detect the analyte. In some examples, the sensing assembly 810 can include an analyte enzyme sensing layer 814 disposed on the working electrode 813 (see Figure 2 ). Thus, when the sensor assembly 810 contacts a test solution containing an analyte, it can generate an electrical signal related to the analyte concentration. For example, a glucose biosensor can have a glucose enzyme sensing layer disposed on its working electrode 813, thereby enabling glucose monitoring.

[0038] Figure 3 1 is a schematic diagram showing the structure of a test system 100 according to one example of the present disclosure.

[0039] For some examples, see Figure 3 The testing system 100 may include a liquid storage device 10 , a delivery device 20 and a testing device 30 .

[0040] In some examples, the liquid storage device 10 may include a variety of liquid storage mechanisms.

[0041] In some examples, the storage device 10 may include an analyte storage mechanism 11 (see Figure 3 In some examples, the analyte storage mechanism 11 may be used to store a solution containing an analyte (also referred to as “analyte solution”).

[0042] In some examples, the analyte can be a chemical substance in the host body fluid. In some examples, the analyte can be selected based on the test requirements of the sensor to be tested. For example, when the sensor is a glucose sensor, glucose can be selected as the analyte. Thus, it is easy to test the relevant performance of the glucose sensor. For another example, when the sensor is a multi-analyte sensor, such as a glucose and ketone dual analyte sensor, the analyte can include glucose and ketones (or, the analyte can be a substance that can indicate glucose or ketones, for example, the concentration of ketones in the test fluid can be indicated by detecting β-hydroxybutyric acid).

[0043] In some examples, the solution containing the analyte can be a buffer containing the analyte. The buffer can include at least one of phosphate buffered saline (PBS), tris (Tris) buffer, and 4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid buffer (HEPES). For example, the solution containing the analyte can be a phosphate buffer containing glucose. In some examples, the buffer can include sodium dihydrogen phosphate, disodium hydrogen phosphate, and / or sodium chloride, etc. Thus, it can help maintain the pH stability of the test solution and provide a stable liquid phase environment, thereby helping to obtain more accurate test results. In addition, it can simulate the pH environment of the human body fluid environment.

[0044] In some examples, the analyte storage mechanism 11 stores a solution containing an analyte at a specific concentration.

[0045] In some examples, the concentration of the analyte in the analyte solution stored in the analyte storage mechanism 11 is not lower than the analyte concentration in the test fluid required in the test requirement. Thus, a higher concentration analyte solution and a conditioning solution (buffer with a concentration of 0) can be mixed to obtain the concentration required by the test requirement. For example, if the test requirement requires the maximum concentration of the analyte in the test fluid to be 20 mmol / L (millimoles per liter), the concentration of the analyte in the analyte solution stored in the analyte storage mechanism 11 must be greater than or equal to 20 mmol / L, for example, it can be 30 mmol / L, 40 mmol / L, etc.

[0046] In some examples, the analyte concentration in the analyte solution stored in the analyte storage mechanism 11 is not lower than the analyte concentration in the human body. Thus, a test solution with a concentration close to the analyte concentration in the human body can be obtained by mixing a higher concentration analyte solution with a conditioning solution (buffer with a concentration of 0).

[0047] In some examples, the number of the analyte storage mechanism 11 can be multiple (see Figure 3The multiple analyte storage mechanisms 11 are each used to store a different analyte. For example, the analyte may be at least one of glucose, blood ketones, lactate, urea, and uric acid. Of course, the analyte may also be other substances not listed. This allows for testing of different analyte sensors and multi-analyte sensors.

[0048] In other examples, the number of the analyte storage mechanism 11 may also be one.

[0049] In some examples, the multiple analyte storage mechanisms 11 may be independent of each other.

[0050] In some examples, among the multiple analyte storage mechanisms 11, each analyte storage mechanism 11 can be used to store solutions containing different analytes. In other words, different analyte storage mechanisms 11 can be used to store solutions containing different analytes. For example, Figure 3 As shown, the number of the analyte storage mechanisms 11 may be two, namely, an analyte storage mechanism 11 a and an analyte storage mechanism 11 b , each for storing a different analyte solution (eg, a first analyte solution and a second analyte solution).

[0051] For some examples, see Figure 3 The liquid storage device 10 may include an analyte liquid storage mechanism 11 a storing a solution containing glucose, and an analyte liquid storage mechanism 11 b storing a solution containing blood ketones.

[0052] In some examples, the liquid storage device 10 may include a regulating liquid storage mechanism 12 .

[0053] In some examples, the number of regulating liquid storage mechanisms 12 may be one or more.

[0054] In some examples, the regulating solution reservoir mechanism 12 is configured to store a regulating solution for adjusting the concentration of an analyte.

[0055] In some examples, the conditioning liquid may be a liquid that does not contain the analyte, for example, a buffer solution, physiological saline, or pure water.

[0056] In some examples, the regulating fluid is a phosphate buffer, which can help simulate the osmotic pressure environment of the human body fluid environment.

[0057] In some examples, the analyte storage mechanism 11 is used to store a solution containing an analyte at a specific concentration, and the regulating liquid storage mechanism 12 is used to store the regulating liquid. By adjusting the supply volume or speed of the analyte solution and the regulating liquid, the concentration of the analyte in the test liquid used to test the analyte sensor 800 can be adjusted.

[0058] Figure 41 is a schematic structural diagram of another example of a test system 100 involved in the examples of the present disclosure.

[0059] For some examples, see Figure 4 The liquid storage device 10 may include an interferent liquid storage mechanism 13 .

[0060] In some examples, the interferor storage mechanism 13 is used to store a solution containing an interferor (also referred to as “interferor solution”).

[0061] In some examples, the reservoir device 10 may include one or more interferent reservoir mechanisms 13 .

[0062] In some examples, among the multiple interferor storage mechanisms 13, each interferor storage mechanism 13 is used to store a solution containing a different interferor. In other words, different interferor storage mechanisms 13 can be used to store solutions containing different interferors.

[0063] In some examples, the interferent may be selected based on the analyte of analyte sensor 800 .

[0064] In some examples, the interferor can include at least one of ascorbic acid, acetaminophen, ibuprofen, aspirin, hydroxyurea, mannose, xylose, and uric acid.

[0065] In some examples, the solution containing an interferor may be a buffer containing an interferor. The buffer may include at least one of phosphate buffered saline (PBS), tris (Tris) buffer, and 4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid buffer (HEPES).

[0066] In some examples, the concentration of the interferent in the test fluid used to test the analyte sensor 800 can be adjusted by adjusting the supply volume or rate of the interferent solution and the conditioning fluid.

[0067] In some examples, the delivery device 20 can be connected to the inlet of the test chamber 32 (described later) and deliver the liquid of the analyte storage mechanism 11 and the regulating liquid storage mechanism 12 to the test chamber 32 to form a test liquid according to a predetermined formula. The predetermined formula is set according to the test requirements of the analyte sensor 800. The test requirements can be a curve of the change of the analyte concentration over time. Thus, the analyte sensor 800 can test the situation when the analyte concentration changes dynamically. It should be noted that the change curve can be a curve of the continuous change of the analyte concentration over time, a curve of the gradient change of the analyte concentration over time, or a discrete point of the analyte concentration at different times.

[0068] In some examples, the analyte concentration in the test solution can be between 0.1 mmol / L and 30 mmol / L. For example, 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 based on 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 a range similar to the glucose concentration in human body fluids.

[0069] In some examples, the pH of the test solution can be 5 to 8. For example, the pH of the test solution can be 5, 5.5, 6, 6.5, 7, 7.5, or 8. This can simulate the pH conditions of a human body fluid environment. Preferably, the pH of the test solution can be 7 to 7.5.

[0070] In some examples, the analyte reservoir mechanism 11 , the regulating solution reservoir mechanism 12 , and the interferent reservoir mechanism 13 may be collectively referred to as a reservoir mechanism.

[0071] In some examples, the delivery device 20 may include multiple delivery mechanisms. The multiple delivery mechanisms may be configured to deliver liquids in different liquid storage mechanisms to the test chamber 32. For example, see Figure 3 The conveying device 20 may include a first conveying mechanism 21 , a second conveying mechanism 22 and a third conveying mechanism 23 .

[0072] In some examples, multiple delivery mechanisms may be connected to different liquid storage mechanisms, respectively. Liquids in different liquid storage mechanisms may be delivered to the testing device 30 through the multiple delivery mechanisms to form test liquids for testing the analyte sensor 800 .

[0073] In some examples, the concentration of the analyte in the test fluid can be adjusted by controlling the flow rate of the liquid in the delivery mechanism. In some examples, the concentration of the analyte in the test fluid can be adjusted by controlling the flow rate of the analyte solution and the regulating liquid through the delivery mechanism. For example, Figure 3 As shown, the concentration of the first analyte in the test fluid can be adjusted by controlling the flow rate of the first analyte solution in the first delivery mechanism 21 and the flow rate of the regulating solution in the third delivery mechanism 23. In some examples, the inner diameters of the tubings of the different delivery mechanisms can be made the same, thereby controlling the flow rate by controlling the flow rate of the delivery mechanism.

[0074] In some examples, the concentration of the interferent in the test fluid can be adjusted by controlling the flow rate of the liquid in the delivery mechanism. In some examples, the concentration of the analyte in the test fluid can be adjusted by controlling the flow rate of the interferent solution and the regulating fluid through the delivery mechanism.

[0075] For some examples, see Figure 3 The testing device 30 may include a testing chamber 32 and a mounting seat 31 .

[0076] In some examples, the test chamber 32 may be configured to contain a test fluid.

[0077] In some examples, the mount 31 can be configured to secure the analyte sensor 800 to be tested and to immerse the testing portion (ie, the implant portion 811 ) of the analyte sensor 800 in a test fluid.

[0078] In some examples, the test fluid may be configured to flow into the test chamber 32 through an inlet of the test chamber 32 and to flow out through an outlet of the test chamber 32. Thus, the analyte sensor 800 may be tested while the test fluid is flowing.

[0079] In some examples, such as Figure 3 As shown, the test chamber 32 may be in the shape of a square groove and may be used to accommodate the inflowing test liquid.

[0080] It should be noted that Figure 3 In order to better display the internal structure of the test device 30, the top of the test chamber 32 is open. In order to reduce the impact of the external environment on the test liquid, in some examples, the test chamber 32 can also be closed. For example, a cover can be provided above the test chamber 32.

[0081] In some examples, the entrance of the test chamber 32 and the exit of the test chamber 32 may be located at two opposite positions of the test chamber 32. Figure 3 As shown, the inlet of the test chamber 32 can be located at the upper left position of the test chamber 32, and the outlet of the test chamber 32 can be located at the lower right position of the test chamber 32. This can facilitate the flow of the test liquid through all positions of the test chamber 32, thereby facilitating the testing of all sensors 800 to be tested and improving the test accuracy.

[0082] like Figure 3 As shown, the number of analyte sensors 800 to be tested can be multiple. Thus, multiple analyte sensors 800 can be tested simultaneously, improving the test efficiency. Figure 3 , multiple analyte sensors 800 are tested simultaneously. In some examples, an analyte sensor 800 may be tested individually. Figure 3The plurality of analyte sensors 800 shown in FIG. 8 are arranged in multiple rows. In some examples, the plurality of analyte sensors 800 may also be arranged in a single row.

[0083] In some examples, the analyte sensor 800 to be tested may be located between the inlet of the test chamber 32 and the outlet of the test chamber 32. This facilitates the flow of the test fluid through each analyte sensor 800 to be tested.

[0084] In some examples, the test fluid flowing out of the outlet of the test chamber 32 may flow into a waste device (not shown) for collection or storage.

[0085] In some examples, the concentration of the analyte or interferor in the test fluid can vary dynamically. In other words, the concentration of the analyte or interferor in the test fluid can be dynamically adjusted over time. For example, the concentration of the analyte or interferor can vary continuously in a curve. This enables continuous, dynamic testing of the analyte sensor 800.

[0086] Figure 5 It shows Figure 4 A partial enlarged view of the test device 30.

[0087] like Figure 4 As shown, in some examples, multiple delivery mechanisms can be connected to different liquid reservoirs. The multiple delivery mechanisms can be configured to collect liquids from different liquid reservoirs into the same conduit and enter the testing chamber 32. For example, the first delivery mechanism 21 and the second delivery mechanism 22 can output the analyte solution from the analyte reservoir 11 and the conditioning solution from the conditioning solution reservoir 12 and collect them into the first conduit 25. The analyte solution and the conditioning solution form the test solution in the first conduit 25.

[0088] In some examples, such as Figure 4 and Figure 5 As shown, the test chamber 32 of the testing device 30 can be cylindrical. In some examples, the inlet and outlet of the test chamber 32 are located on the bottom surfaces of the cylinder, respectively, and the test liquid flows along the height of the cylinder. In some examples, the analyte sensors 800 to be tested can be distributed along the height of the cylinder.

[0089] In some examples, the ratio of the diameter of the test chamber 32 to the diameter of the first pipe 25 can be 0.5 to 2. In other words, the diameter of the test chamber 32 can be 0.5 to 2 times the diameter of the first pipe 25. For example, the diameter of the test chamber 32 can be 0.5, 1, 1.5, or 2 times the diameter of the first pipe 25.

[0090] In some examples, the diameter of the test chamber 32 can be the same as the diameter of the first pipe 25. In this case, the shape of the test chamber 32 and the shape of the first pipe 25 are both cylindrical and have the same diameter. The liquid flowing through the first pipe 25 can then flow directly through the test chamber 32. This can help make the content of the test liquid in the test chamber 32 more uniform and stable, further improving the accuracy of the test. It should be noted that compared to Figure 3 The structure of the test chamber 32 shown in the square groove shape, Figure 4 or Figure 5 With the cylindrical structure of the test chamber 32 (the test chamber 32 and the first pipe 25 are both cylindrical and have the same diameter), the test liquid may be more evenly distributed in the test chamber 32 .

[0091] Figure 6 It shows Figure 4 Schematic diagram of the structure of the testing device 30.

[0092] In some examples, the mounting base 31 can be a small hole located on the surface of the test chamber 32 (e.g., Figure 6 (as shown). The implant portion 811 of the analyte sensor 800 can enter the test chamber 32 through the aperture and be immersed in the test fluid for testing. The aperture can also be provided with a seal (not shown), such as a rubber seal, to seal the aperture after the implant portion 811 enters. This helps improve the sealing performance of the testing device 30.

[0093] In some examples, after the analyte sensor 800 is tested using the test system 100, the delivery mechanism 22 can continue to deliver the conditioning liquid to the test device 30 for a predetermined time, and other delivery mechanisms (such as the delivery mechanism 21 or the delivery mechanism 23) stop delivering liquid to the test device 30 to "clean" the test chamber 32 to reduce residual analytes or interferents, thereby reducing interference or impact on subsequent analyte sensor 800 tests.

[0094] Figure 7 FIG. 1 is a block diagram illustrating a test system 100 according to an example of the present disclosure.

[0095] like Figure 7 As shown, in some examples, the test system 100 may further include a temperature control device 40 .

[0096] In some examples, the temperature control device 40 is configured to adjust the temperature of the test fluid in the test device 30. This facilitates in vitro simulation of the effect of human body temperature changes on the analyte sensor 800.

[0097] In some examples, the temperature control device 40 controls the temperature of the test fluid in the test device 30 according to test requirements.

[0098] In some examples, the temperature control device 40 can control the temperature of the test fluid by controlling or adjusting the temperature of the fluid in the storage device 10 or the temperature of the fluid in the delivery device 20. In other examples, the temperature control device 40 can directly control the temperature of the fluid in the test device 30.

[0099] In some examples, the temperature control device 40 may include a temperature sensor (not shown) configured to sense the temperature of the test fluid in the test chamber 32 .

[0100] For some examples, see Figure 7 The testing system 100 may further include an atmosphere adjustment device 50 .

[0101] In some examples, the atmosphere conditioning device 50 is configured to adjust the oxygen content of the test fluid in the testing device 30. This facilitates in vitro analysis of the effects of hypoxia on the analyte sensor 800. In some examples, the atmosphere conditioning device 50 controls the oxygen content of the test fluid in the testing device 30 based on test requirements.

[0102] In some examples, the atmosphere adjustment device 50 can control the oxygen content of the test liquid by controlling or adjusting the oxygen content of the liquid in the storage device 10 or the oxygen content of the liquid in the delivery device 20. In other examples, the atmosphere adjustment device 50 can directly control the oxygen content of the liquid in the test device 30.

[0103] In some examples, the temperature control device 40 may include an oxygen content sensor (not shown) for sensing the oxygen content of the test fluid in the test chamber 32 .

[0104] For some examples, see Figure 7 The test system 100 may further include a control device 60 .

[0105] In some examples, the control device 60 may be electrically connected to at least one of the delivery device 20 , the temperature control device 40 , and the atmosphere adjustment device 50 .

[0106] In some examples, the control device 60 can be configured to control the delivery device 20, the temperature control device 40 and / or the atmosphere adjustment device 50 to adjust the analyte concentration, interferor concentration, temperature and / or oxygen content in the test fluid according to the test requirements input.

[0107] In some examples, a test requirement may be input to the control device 60 , and the conveying device 20 , the temperature control device 40 , or the atmosphere adjustment device 50 may be controlled according to the test requirement.

[0108] In some examples, the control device 60 adjusts the analyte concentration and / or interferor concentration in the test fluid by controlling the flow rate of the liquid in different delivery mechanisms of the delivery device 20 according to the test requirements, so that the analyte concentration or interferor concentration in the test fluid corresponds to the test requirements.

[0109] In some examples, the test requirements may include at least one of the following: a curve showing a change in analyte concentration over time, a curve showing a change in interferor concentration over time, a curve showing a change in temperature over time, and a curve showing a change in oxygen content over time. It should be noted that the change curve may be a curve showing a continuous change in analyte concentration (or interferor concentration, temperature, or oxygen content) over time, a curve showing a gradient change in analyte concentration (or interferor concentration, temperature, or oxygen content) over time, or a curve showing discrete points of analyte concentration (or interferor concentration, temperature, or oxygen content) at different times.

[0110] In some examples, test requirements can be set according to actual needs.

[0111] In some examples, the test system 100 of the present disclosure can implement continuous testing of the analyte sensor 800 , and can simulate changes in human body temperature and oxygen content to test the effects of temperature changes or oxygen content changes on the analyte sensor 800 .

[0112] The present disclosure also relates to a method for testing the analyte sensor 800 .

[0113] Figure 8 FIG. 8 is a flow chart illustrating a method for testing an analyte sensor 800 according to an example of the present disclosure.

[0114] In some examples, the test fluid may be flowed to test the analyte sensor 800 .

[0115] In some examples, the analyte sensor 800 is tested using the testing system 100 described above.

[0116] like Figure 8 As shown, the testing method may include: fixing the analyte sensor 800 to be tested on the testing device 30 (step S1); supplying the testing fluid to the testing device 30 according to the input testing requirements (step S2); and allowing the testing fluid to test the analyte sensor 800 in a flowing state (step S3).

[0117] In some examples, based on the input test requirements, the delivery device 20 can be controlled to adjust at least one of the following parameters in the test fluid at different times: the concentration of various analytes, the concentration of various interferents, temperature, and oxygen content, so that the parameters in the test fluid correspond to the test requirements.

[0118] In some examples, during the test process, the test fluid is continuously supplied to the test chamber 32 so that the test fluid is in a flowing state to test the analyte sensor 800 .

[0119] In some examples, during the test process, the delivery device 20 is configured to continuously deliver liquid to the test chamber 32 so that the test liquid can test the analyte sensor 800 in a flowing state.

[0120] In some examples, after the test is completed, the analyte sensor 800 can be removed from the test device 30, and then the delivery mechanism 22 can continue to deliver the conditioning liquid to the test device 30 for a predetermined time, and other delivery mechanisms (such as the delivery mechanism 21 or the delivery mechanism 23) stop delivering liquid to the test device 30 to "clean" the test chamber 32 to reduce residual analytes or interferents, thereby reducing interference or impact on subsequent analyte sensor 800 tests.

[0121] The foregoing description is merely a preferred embodiment of the present disclosure and is not intended to limit the present disclosure. Those skilled in the art will readily appreciate that various modifications and variations are possible. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present disclosure shall be included within the scope of protection of the present disclosure.

[0122] In summary, the test system and test method disclosed herein can simulate the continuous change trend and interference occurrence of analytes in the human body in vitro, which is conducive to evaluating the accuracy, anti-interference, delay and other performance of the sensor.

[0123] Although the present disclosure has been described in detail above with reference to the accompanying drawings and embodiments, it will be understood that the above description does not limit the present disclosure in any form. Those skilled in the art may modify and change the present disclosure as needed without departing from the spirit and scope of the present disclosure, and such modifications and variations all fall within the scope of the present disclosure.

Claims

1. A testing system for an analyte sensor, characterized in that: It includes a liquid storage device, a delivery device and a testing device; The liquid storage device includes a regulating liquid storage mechanism for storing a regulating liquid for regulating the concentration of an analyte, and one or more independent analyte storage mechanisms; when there are multiple analyte storage mechanisms, each analyte storage mechanism is used to store a solution containing a different analyte; The testing device includes a testing chamber configured to contain a test liquid and a mounting base, wherein the test liquid is configured to flow into the testing chamber through an inlet of the testing chamber and to flow out through an outlet of the testing chamber, and the mounting base is configured to fix the analyte sensor to be tested and immerse the testing portion of the analyte sensor in the test liquid; The delivery device is in communication with the inlet of the test chamber and delivers the liquids of the analyte storage mechanism and the regulating liquid storage mechanism to the test chamber to form the test liquid according to a predetermined formula, wherein the predetermined formula is set according to the test requirements of the analyte sensor; During the test process, the delivery device is configured to continuously deliver liquid to the test chamber, so that the test liquid tests the analyte sensor in a flowing state.

2. The test system according to claim 1, wherein: The conditioning liquid is a liquid that does not contain the analyte.

3. The test system according to claim 1, wherein: The delivery device includes a plurality of delivery mechanisms, and the plurality of delivery mechanisms are configured to deliver liquids in different liquid storage mechanisms to the testing chamber respectively.

4. The test system according to claim 3, characterized in that The concentration of the analyte in the test fluid is adjusted by controlling the liquid flow in the delivery mechanism.

5. The test system according to claim 3, characterized in that: The liquid storage device further comprises one or more interferent liquid storage mechanisms, wherein each of the multiple interferent liquid storage mechanisms is used to store a solution containing a different interferent.

6. The test system according to claim 5, characterized in that: The test system satisfies at least one of the following requirements: The analyte comprises at least one of glucose, lactate, ketone bodies, uric acid, and urea; The interferor comprises at least one of ascorbic acid, acetaminophen, ibuprofen, aspirin, hydroxyurea, mannose, xylose and uric acid.

7. The test system according to claim 3, wherein: The plurality of conveying mechanisms are configured to respectively collect the liquids in different liquid storage mechanisms into the first pipe and then allow the liquids to enter the testing chamber.

8. The test system according to claim 7, wherein: The ratio of the diameter of the test chamber to the diameter of the first pipe is 0.5 to 2.

9. The test system according to any one of claims 5 to 8, characterized in that: The testing system also includes at least one of the following: a temperature control device, an atmosphere adjustment device and a control device; wherein the temperature control device is configured to adjust the temperature of the test liquid in the testing device, the atmosphere adjustment device is configured to adjust the oxygen content of the test liquid in the testing device, and the control device is electrically connected to at least one of the conveying device, the temperature control device and the atmosphere adjustment device, and the control device is configured to control the conveying device, the temperature control device and / or the atmosphere adjustment device to adjust the analyte concentration, interferent concentration, temperature and / or oxygen content in the test liquid according to the test requirements input.

10. A method for testing an analyte sensor, characterized in that: An analyte sensor is tested using the test system according to any one of claims 1 to 9, wherein the test method comprises: fixing the analyte sensor to be tested on a testing device; supplying a test fluid to the test device according to an input test requirement; The test fluid is allowed to flow to test the analyte sensor.

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