A detection device and a detection method

Abstract

The application belongs to the technical field of biological detection and particularly relates to a detection device and a detection method. The detection device provided by the application comprises: a sample feeding module for placing a to-be-tested reagent product; the to-be-tested reagent product comprises double-layer detection test paper, and the double-layer detection test paper shares one to-be-tested sample; a mixed detection module adjacent to the sample feeding module for one-stop detection of the C peptide concentration, the insulin concentration and the blood glucose concentration of the to-be-tested sample; a hardware module connected with the mixed detection module for collecting detection signals, converting and generating detection results; a display module connected with the hardware module for outputting the detection results; a temperature control module connected with the sample feeding module for adjusting temperature; and a power module for power supply. The detection device integrates the detection methods of C peptide, insulin and blood glucose into one instrument device to realize one-stop detection, and has small volume and portability.

Description

Technical Field

[0001] This invention belongs to the field of biological detection equipment technology, and specifically relates to a detection device and detection method. Background Technology

[0002] Pancreatic islet function plays a crucial role in clinical diagnosis. Research on pancreatic islet function has core guiding value for the entire process of diabetes diagnosis and treatment and the management of metabolic diseases, and is a key support for improving the accuracy of diagnosis and treatment and patient prognosis. Significant progress has also been made in research on the pancreas and metabolism, such as the relationship between the pancreas and metabolic organs like the liver, fat, and muscle.

[0003] The pancreatic function index, calculated and analyzed from three indicators—C-peptide, blood glucose, and insulin—is an important indicator for clinical diagnosis. With current technological advancements, C-peptide and insulin are typically tested using chemiluminescent immunoassay or dry fluorescence immunoassay. Blood glucose testing methods are more diverse, including venous blood tests and finger-prick blood tests, and methods such as hexokinase, glucose oxidase, glucose dehydrogenase, electrochemical methods, and optical detection methods.

[0004] Current detection methods, such as chemiluminescence / dry fluorescence detection of C-peptide and insulin, lack the ability to detect blood glucose; similarly, electrochemical / dry biochemical detection of blood glucose lacks the ability to detect C-peptide and insulin. Due to the different detection methods, these methods typically cannot be performed independently by a single instrument. Based on these issues, detecting pancreatic function indices requires at least two instruments to separately detect C-peptide, insulin, and blood glucose. Currently available instruments cannot simultaneously measure these three indicators, thus failing to provide an assessment of pancreatic function. Even if two instruments were assembled to simultaneously detect these three indicators, they would be bulky and inconvenient to carry. Summary of the Invention

[0005] The purpose of this invention is to provide a detection device and a detection method. The detection device provided by this invention integrates the detection methods for three indicators—C-peptide, insulin, and blood glucose—into a single instrument, enabling one-stop detection of these three indicators. Furthermore, the device is small and portable, solving the industry pain point of requiring multiple instruments for assessing pancreatic function indices. It is also suitable for both home and medical use for pancreatic function testing and assessment.

[0006] The first aspect of the present invention provides a detection device, the detection device comprising: The sample injection module is used to place the test reagent product; the test reagent product includes a double-layer test strip, the double-layer test strip includes a sample pad, the sample pad is used to hold the test sample, and the double-layer test strip shares a single test sample; The hybrid detection module, adjacent to the sample injection module, is used for one-stop detection of C-peptide concentration, insulin concentration, and blood glucose concentration in the sample to be tested; A hardware module, connected to the hybrid detection module, is used to acquire the detection signal generated by the hybrid detection module, convert the detection signal to generate a detection result; the hardware module is also used to control the circuit of the detection device. The display module, connected to the hardware module, is used to output the detection results, including C-peptide concentration, insulin concentration, and blood glucose concentration. The temperature control module, connected to the sample injection module, is used to adjust the incubation temperature of the double-layer test strip during the incubation process. The power supply module is electrically connected to at least the hybrid detection module, the hardware module, the display module, and the temperature control module, and supplies power to the hybrid detection module, the hardware module, the display module, and the temperature control module respectively.

[0007] In some embodiments, the hybrid detection module is used to complete at least one of dry fluorescence immunoassay and chemiluminescence immunoassay in one stop, as well as at least one of electrochemical detection and optical detection. In some embodiments, the dry fluorescence immunoassay and chemiluminescence immunoassay are used to detect the concentration of C-peptide and insulin in the sample to be tested, and the electrochemical detection and optical detection are used to detect the concentration of blood glucose in the sample to be tested.

[0008] In some implementations, the hybrid detection module is used to perform dry fluorescence immunoassay and electrochemical detection in a single step.

[0009] In some embodiments, the hybrid detection module includes a first detection channel and a second detection channel; the first detection channel is used to detect the concentrations of C-peptide and insulin in the sample to be tested; the second detection channel is used to detect the concentration of blood glucose in the sample to be tested. The first and second detection channels operate independently without interfering with each other.

[0010] In some embodiments, the hybrid detection module includes a dry fluorescence detection module and a circuit detection module; the dry fluorescence detection module is used to perform dry fluorescence immunoassay to detect the concentration of C-peptide and insulin in the sample; the circuit detection module is used to perform electrochemical detection of blood glucose concentration in the sample; the dry fluorescence detection module and the circuit detection module work independently and do not interfere with each other. In some embodiments, the hybrid detection module is disposed on the side of the test reagent product; the hybrid detection module includes: a light source, an aperture, a lens, a filter, and a fluorescence detection sensor; Along a direction perpendicular to the test plane of the test reagent product, the lens, filter, and fluorescence detection sensor are sequentially and spaced apart above the test reagent product, with the lens and the test reagent product being adjacent to each other.

[0011] In some embodiments, the light emitted by the light source is obliquely incident on the test reagent product; The axis formed by the arrangement of the test reagent, lens, filter, and fluorescence detection sensor intersects with the light emitted by the light source.

[0012] In some embodiments, an aperture stop is also provided along the path of the light generated by the light source; In some implementations, the hardware module is used to analyze the detection results to obtain analysis results, which include pancreatic islet function index; The display module is used to output the analysis results.

[0013] In some embodiments, the detection device further includes: a communication module; In some implementations, the communication module is connected to the hardware module and is used to output the detection results to the mobile terminal.

[0014] In some embodiments, the reagent product includes at least one of the following: test card, test kit, test strip; The dual-layer test strip has a dual-layer structure; The double-layer test strip has a top layer for C-peptide and insulin concentration testing, and a bottom layer for blood glucose testing.

[0015] In some embodiments, the dual-layer test strip has a dual-layer structure, with the upper layer being a dry fluorescent test strip and the lower layer being an electrochemical test strip; In some embodiments, the electrochemical test strip includes an auxiliary electrode, a working electrode, a reference electrode, and an automatic identification electrode.

[0016] In some embodiments, the test reagent product further includes an upper shell and a lower shell, and the double-layer test strip is located in the cavity formed by assembling the upper shell and the lower shell; The upper shell has a dropper hole for the sample to be tested and a result observation window.

[0017] A second aspect of the present invention provides a detection method using the above-described detection device, comprising the following steps: The sample to be tested is placed on the sample pad of the double-layer test strip to form the test reagent product. Then, the test reagent product is placed in the injection module, and the detection device automatically completes the incubation and detection. Finally, the detection result is displayed on the display screen of the display module. The test results include: C-peptide concentration, insulin concentration, and blood glucose concentration.

[0018] In some embodiments, the detection device also transmits the detected C-peptide concentration, insulin concentration, and blood glucose concentration results to a mobile terminal.

[0019] Compared with the prior art, the present invention has the following advantages: 1. The detection device provided by this invention integrates the detection methods of three indicators, namely C-peptide, insulin and blood glucose, into one instrument, which can perform one-stop detection of the above three indicators, thereby further being used for comprehensive evaluation of pancreatic islet function index. Moreover, the detection device is small in size and portable, solving the industry pain point that multiple instruments are needed to evaluate pancreatic islet function index. It is also suitable for home and medical use for pancreatic islet function detection and evaluation.

[0020] 2. The detection device provided by this invention supports dry fluorescence immunoassay and electrochemical detection, and can simultaneously detect C-peptide, blood glucose and insulin, solving the problem of needing multiple instruments to assess pancreatic function index.

[0021] 3. The detection device provided by this invention is mainly used for rapid detection, real-time analysis and remote data management, and is suitable for multiple scenarios such as clinical, bedside and home use.

[0022] The above description is merely an overview of the technical solution of the present invention. In order to better understand the technical means of the present invention and to implement it in accordance with the contents of the specification, and in order to make the above and other objects, features and advantages of the present invention more apparent and understandable, specific embodiments of the present invention are described below. Attached Figure Description

[0023] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0024] Figure 1 This is a schematic diagram of the main components of the instrument of the present invention; Figure 2 This is a schematic diagram of the dry fluorescence detection module in the hybrid detection module. Figure 3 This is a schematic diagram of a double-layer test strip; Figure 4 This is a schematic diagram of the instrument's workflow.

[0025] Explanation of reference numerals in the attached figures: 1-Sample introduction module, 2-Power supply module, 3-Mixed detection module, 4-Display module, 5-Instrument housing, 11-Test reagent product, 12-Lens, 13-Filter, 14-Fluorescence detection sensor, 15-Light source, 16-Aperture, 111-Dry fluorescence test paper, 112-Electrochemical test paper, 113-Upper shell, 114-Lower shell, 1121-Auxiliary electrode, 1122-Working electrode, 1123-Reference electrode, 1124-Automatic identification electrode. Detailed Implementation

[0026] Exemplary embodiments of the invention will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the invention are shown in the drawings, it should be understood that the invention can be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of the invention and to fully convey the scope of the invention to those skilled in the art.

[0027] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also include the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a particular order described or illustrated unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0028] In the description of the embodiments of this invention, technical terms such as "first" and "second" are used only to distinguish different objects and should not be construed as indicating or implying relative importance or implicitly specifying the number, specific order, or primary and secondary relationship of the indicated technical features. In the description of the embodiments of this invention, "multiple" means two or more, unless otherwise explicitly defined.

[0029] In this document, the term "embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of the invention. The appearance of this phrase in various places throughout the specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment mutually exclusive with other embodiments. It will be explicitly and implicitly understood by those skilled in the art that the embodiments described herein can be combined with other embodiments.

[0030] In the description of the embodiments of this invention, the term "and / or" is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A existing alone, A and B existing simultaneously, and B existing alone. Additionally, the character " / " in this document generally indicates that the preceding and following related objects have an "or" relationship.

[0031] In the description of the embodiments of the present invention, the term "multiple" refers to two or more (including two), similarly, "multiple groups" refers to two or more (including two groups), and "multiple pieces" refers to two or more (including two pieces).

[0032] In the description of the embodiments of the present invention, unless otherwise explicitly specified and limited, the technical terms such as "installation," "connection," "joining," and "fixing" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in the embodiments of the present invention according to the specific circumstances.

[0033] The following explanations and descriptions of some aspects of this invention are provided to enable those skilled in the art to understand them.

[0034] The first aspect of the present invention provides a detection device, combined with Figure 1 The detection device includes: a sample injection module 1, a power supply module 2, a mixed detection module 3, a hardware module, a display module 4, and a temperature control module. The sample injection module 1 holds the test reagent product 11, which includes a double-layer test strip. Each double-layer test strip includes a sample pad to hold the test sample; both layers share a single test sample. The mixed detection module 3, adjacent to the sample injection module 1, is used for one-stop detection of C-peptide, insulin, and blood glucose concentrations in the test sample. The hardware module, connected to the mixed detection module 3, is used to collect data from the mixed detection module 3. The generated detection signal is converted into a detection result; the hardware module is also used to control the circuitry of the detection device; the display module 4, connected to the hardware module, is used to output the detection results, including C-peptide concentration, insulin concentration, and blood glucose concentration; the temperature control module, connected to the sample injection module 1, is used to adjust the incubation temperature of the double-layer test strip to be tested in the sample injection module 1 during the incubation process; the power supply module 2 is electrically connected to at least the mixed detection module 3, the hardware module, the display module 4, and the temperature control module, and the power supply module 2 supplies power to the mixed detection module 3, the hardware module, the display module 4, and the temperature control module respectively. The detection device also includes an instrument housing 5, which is used to enclose the above modules and protect them.

[0035] The detection device provided by this invention integrates the detection methods of three indicators, namely C-peptide, insulin, and blood glucose, into one instrument. It can perform one-stop detection of the above three indicators for further comprehensive evaluation of pancreatic islet function index. The detection device is small and portable, solving the industry pain point that multiple instruments are needed to evaluate pancreatic islet function index. It is also suitable for home and medical use for pancreatic islet function detection and evaluation.

[0036] In some implementations, the hardware module is also used to control the instrument to perform a self-test after the instrument is turned on.

[0037] In some implementations, the hardware module controls the temperature control module to regulate the temperature.

[0038] In some implementations, the sample injection module 1 can be manually injected or connected to the power module 2 to achieve automatic sample injection through hardware module control.

[0039] In some embodiments, the detection device further includes a communication module; the communication module is connected to the hardware module and is used to output detection results to the mobile terminal. In some embodiments, the communication module is connected to the hardware module and is used to receive instructions from the mobile terminal to the hardware module, and the hardware module generates detection results and outputs them to the mobile terminal.

[0040] In some embodiments, the hybrid detection module is used to perform at least one of dry fluorescence immunoassay and chemiluminescence immunoassay in a one-stop manner, as well as at least one of electrochemical detection and optical detection; the dry fluorescence immunoassay and chemiluminescence immunoassay are used to detect the concentration of C-peptide and insulin in the sample to be tested, and the electrochemical detection and optical detection are used to detect the concentration of blood glucose in the sample to be tested; in some embodiments, the hybrid detection module is used to perform both dry fluorescence immunoassay and electrochemical detection in a one-stop manner.

[0041] In some embodiments, the hybrid detection module 3 includes a first detection channel and a second detection channel; the first detection channel is used to detect the concentrations of C-peptide and insulin in the sample to be tested; the second detection channel is used to detect the concentration of blood glucose in the sample to be tested. The first and second detection channels operate independently and do not interfere with each other.

[0042] In some implementations, the first detection channel is used to detect the upper layer of the double-layer test strip, and the second detection channel is used to detect the lower layer of the double-layer test strip.

[0043] In some implementations, the hybrid detection module 3 includes a dry fluorescence detection module and a circuit detection module; the dry fluorescence detection module is used to perform dry fluorescence immunoassay to detect the concentrations of C-peptide and insulin in the sample; the circuit detection module is used to perform electrochemical detection of blood glucose concentration in the sample. The dry fluorescence detection module and the circuit detection module operate independently without interference.

[0044] Combination Figure 2 The dry fluorescence detection module is positioned on one side of the test reagent product 11. The dry fluorescence detection module includes a light source 15, an aperture 16, a lens 12, a filter 13, and a fluorescence detection sensor 14. Along a direction perpendicular to the test plane of the test reagent product 11, the lens 12, filter 13, and fluorescence detection sensor 14 are sequentially and spaced apart above the test reagent product 11, with the lens 12 adjacent to the test reagent product 11. The direction perpendicular to the test plane of the test reagent product 11 is... Figure 2 The first direction shown.

[0045] In some embodiments, the light emitted by the light source is obliquely irradiated onto the test reagent product 11; the axis formed by the test reagent product 11, lens 12, filter 13 and fluorescence detection sensor 14 intersects the light emitted by the light source; in some embodiments, an aperture 16 is also provided along the path of the light emitted by the light source.

[0046] In some implementations, the first detection channel is a dry fluorescence detection module used to detect the upper layer of the double-layer test strip, and the second detection channel is a circuit detection module used to detect the lower layer of the double-layer test strip.

[0047] In some embodiments, the dual-layer test strip has a dual-layer structure; the upper layer of the dual-layer test strip is a C-peptide concentration and insulin concentration test strip, and the lower layer is a blood glucose test strip.

[0048] In some implementations, combined Figure 3 The test reagent product 11 includes a dual-layer test strip, which has a dual-layer structure: the upper layer is a dry fluorescent test strip 111, and the lower layer is an electrochemical test strip 112. In some embodiments, the test reagent product includes at least one of the following: a test card, a test kit, and a test strip; In some embodiments, the electrochemical test strip 112 for detecting blood glucose can be configured with various electrode arrangements, such as dual-electrode, triple-electrode, and five-electrode schemes. For example, the electrochemical test strip may optionally include an auxiliary electrode 1121, a working electrode 1122, a reference electrode 1123, and an automatic identification electrode 1124.

[0049] In some embodiments, the circuit detection module connects to the auxiliary electrode 1121, working electrode 1122, reference electrode 1123, and automatic identification electrode 1124 on the electrochemical test strip; wherein the auxiliary electrode 1121 forms a current path with the working electrode 1122; it is responsible for current conduction and does not participate in the reaction; the working electrode 1122 is coated with glucose oxidase and is the reaction electrode, where the sample to be tested undergoes a redox reaction and generates current; the reference electrode 1123 provides a known and fixed potential, which the circuit detection module uses as a reference to precisely control the voltage of the working electrode; the automatic identification electrode 1124 is used for the identification of the electrochemical test strip 112 and stores information such as reagent batch number, calibration curve, and expiration date.

[0050] In some embodiments, the test reagent product further includes an upper shell 112 and a lower shell 113, with the double-layer test strip located in the cavity formed by assembling the upper shell 112 and the lower shell 113; the upper shell has a test sample dropper hole and a result observation window.

[0051] In some implementations, the dry fluorescence detection module detects the concentrations of C-peptide and insulin in the sample by detecting the upper dry fluorescence detection strip 111 of the double-layer test strip 11; the circuit detection module detects the concentration of blood glucose in the sample by detecting the lower electrochemical detection strip 112 of the double-layer test strip 11. The dry fluorescence detection module and the circuit detection module work independently without interference, but the detection is completed on the same double-layer test strip, which greatly reduces the size of the detection device. This achieves the integration of the detection methods for C-peptide, insulin, and blood glucose into a single instrument for one-stop detection, resulting in a small and portable device.

[0052] In some embodiments, the upper dry fluorescent test strip and the lower electrochemical test strip of the dual-layer test strip 11 are independent of each other and do not affect each other; when the sample to be tested is dropped into the sample dropper well, it enters the upper and lower test strips (the upper dry fluorescent test strip and the lower electrochemical test strip). In some embodiments, there is a gap or a separator between the upper dry fluorescent test strip and the lower electrochemical test strip of the dual-layer test strip 11.

[0053] In some implementations, the hardware module is also used to analyze the test results to obtain analysis results, including pancreatic function indices.

[0054] The pancreatic islet function index is an index used to assess pancreatic islet function in patients. It is calculated based on C-peptide, insulin, and blood glucose levels.

[0055] In some implementations, when the hardware module obtains analysis results, including pancreatic function indices, the display module is also used to output the analysis results.

[0056] Combination Figure 4 The detection device of this invention operates as follows: a bilayer test strip or test reagent containing the sample to be tested is placed in the sample introduction module, where it is automatically incubated. Then, the concentrations of C-peptide, insulin, and blood glucose are simultaneously detected by the mixing detection module. After detection, the hardware module acquires the detection signal generated by the mixing detection module, converts the signal to generate the detection result, and then outputs the result through the display module. The detection result includes the detection of C-peptide, insulin, and blood glucose concentrations. In some optional embodiments, the detection result also includes a pancreatic function index. In some optional embodiments, the detection result can also be output to a mobile terminal via a communication module.

[0057] A second aspect of the present invention provides a detection method using the above-described detection device, comprising the following steps: The sample to be tested is placed on the sample pad of the double-layer test strip to form the test reagent product. Then, the test reagent product is placed in the injection module, and the detection device automatically completes the incubation and detection. Finally, the detection result is displayed on the display screen of the display module. The test results include: C-peptide concentration, insulin concentration, and blood glucose concentration.

[0058] In some implementations, the detection device also transmits the detected C-peptide concentration, insulin concentration, and blood glucose concentration results to a mobile terminal.

[0059] Unless otherwise defined, the technical terms used in the following embodiments have the same meaning as commonly understood by those skilled in the art. Unless otherwise specified, the experimental reagents used in the following embodiments are conventional biochemical reagents; the raw materials, instruments, and equipment used in the following embodiments can all be obtained commercially or through existing methods; unless otherwise specified, the amounts of experimental reagents used are the amounts used in conventional experimental operations; unless otherwise specified, the experimental methods are conventional methods. It should be further noted that the following descriptions are merely exemplary and not intended to limit the specific scope of the invention. Moreover, the comparative examples below are selected to compare with the technical solutions of the present invention to demonstrate the advancement of the present invention, and do not necessarily represent prior art in this technical field.

[0060] Example 1 This embodiment provides a detection device, which includes: a sample injection module 1, a power supply module 2, a hybrid detection module 3, a hardware module, a display module 4, and a temperature control module. The sample injection module 1 is used to hold the test reagent product 11. The test reagent product 11 includes a double-layer test strip, which has a double-layer structure: the upper layer is a dry fluorescence test strip, and the lower layer is an electrochemical test strip. The electrochemical test strip includes an auxiliary electrode, a working electrode, a reference electrode, and an automatic identification electrode. The double-layer test strip also includes a sample pad for holding the test sample; the double-layer test strip shares a single sample pad and the test sample. The hybrid detection module 3, adjacent to the sample injection module 1, is used to complete both dry fluorescence immunoassay and electrochemical detection in one stop. This device provides one-stop detection of C-peptide, insulin, and blood glucose concentrations in a sample. A hardware module, connected to the mixed detection module 3, collects and converts the detection signals generated by the mixed detection module 3 to produce results. The hardware module also controls the circuitry of the detection device. A display module 4, connected to the hardware module, outputs the detection results, including C-peptide, insulin, and blood glucose concentrations. A temperature control module, connected to the sample injection module 1, adjusts the incubation temperature of the double-layer test strip in the sample injection module 1 during the incubation process. A power module 2, electrically connected to the mixed detection module 3, hardware module, display module 4, and temperature control module, supplies power to these modules. The device also includes an instrument housing 5 to enclose and protect the modules.

[0061] The hybrid detection module includes a dry fluorescence detection module and a circuit detection module. The dry fluorescence detection module is used to perform dry fluorescence immunoassay to detect the concentrations of C-peptide and insulin in the test sample. The circuit detection module connects to the auxiliary electrode, working electrode, reference electrode, and automatic identification electrode on the electrochemical test strip to perform electrochemical detection of blood glucose concentration in the test sample. The dry fluorescence detection module is located on one side of the test reagent product. The dry fluorescence detection module includes a light source, an aperture, a lens, a filter, and a fluorescence detection sensor. Along a direction perpendicular to the test plane of the test reagent product, the lens, filter, and fluorescence detection sensor are sequentially and spaced above the test reagent product, with the lens and the test reagent product adjacent to each other. The light generated by the light source shines obliquely onto the test reagent product. An aperture is also set along the path of the light generated by the light source. The axis formed by the test reagent product, lens, filter, and fluorescence detection sensor intersects with the light generated by the light source.

[0062] This embodiment also provides a detection method for the above-mentioned detection device, including the following steps: The sample to be tested is placed on the sample pad of the double-layer test strip to form the test reagent product. Then, the test reagent product is placed in the injection module, and the detection device automatically completes the incubation and detection. Finally, the detection result is displayed on the display screen of the display module. The test results include: blood glucose concentration, C-peptide concentration, insulin concentration, and blood glucose concentration.

[0063] Performance Comparison The existing chemiluminescence immunoassay method is used to detect the concentration of C-peptide and insulin, and the detection platform is a chemiluminescence immunoassay analyzer.

[0064] There are many methods for blood glucose testing. Currently available methods include the hexokinase method and the glucose oxidase method, as well as the electrochemical method used in home fingertip blood glucose meters (such as the Sinocare SC801 blood glucose meter). The advantage of this invention is that it allows for one-stop testing of the three pancreatic function index indicators—C-peptide, insulin, and blood glucose—without requiring multiple samples or instruments. Furthermore, the instrument is portable and can directly assess the patient's pancreatic function status through algorithms, providing an evaluation index, thus greatly improving portability and testing speed. Moreover, the detection device in Example 1 has essentially the same detection accuracy as existing methods.

[0065] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A detection device, characterized in that, The detection device includes: The sample injection module is used to place the test reagent product; the test reagent product includes a double-layer test strip, the double-layer test strip includes a sample pad, the sample pad is used to hold the test sample, and the double-layer test strip shares a single test sample; The hybrid detection module, adjacent to the sample injection module, is used for one-stop detection of C-peptide concentration, insulin concentration, and blood glucose concentration in the sample to be tested; A hardware module, connected to the hybrid detection module, is used to acquire the detection signal generated by the hybrid detection module, convert the detection signal to generate a detection result; the hardware module is also used to control the circuit of the detection device. The display module, connected to the hardware module, is used to output the detection results, including C-peptide concentration, insulin concentration, and blood glucose concentration. The temperature control module, connected to the sample injection module, is used to adjust the incubation temperature of the double-layer test strip during the incubation process. The power supply module is electrically connected to at least the hybrid detection module, the hardware module, the display module, and the temperature control module, and supplies power to the hybrid detection module, the hardware module, the display module, and the temperature control module respectively.

2. The detection device according to claim 1, characterized in that, The hybrid detection module is used to complete at least one of dry fluorescence immunoassay and chemiluminescence immunoassay in one stop, as well as at least one of electrochemical detection and optical detection. The dry fluorescence immunoassay and chemiluminescence immunoassay are used to detect the concentrations of C-peptide and insulin in the sample to be tested, and the electrochemical detection and optical detection are used to detect the concentration of blood glucose in the sample to be tested. And / or, the hybrid detection module is used to complete dry fluorescence immunoassay and electrochemical detection in one stop.

3. The detection device according to claim 1 or 2, characterized in that, The hybrid detection module includes a first detection channel and a second detection channel; the first detection channel is used to detect the concentrations of C-peptide and insulin in the sample to be tested; the second detection channel is used to detect the concentration of blood glucose in the sample to be tested. The first and second detection channels operate independently without interfering with each other.

4. The detection device according to claim 1 or 2, characterized in that, The hybrid detection module includes a dry fluorescence detection module and a circuit detection module; the dry fluorescence detection module is used to perform dry fluorescence immunoassay to detect the concentrations of C-peptide and insulin in the sample; the circuit detection module is used to perform electrochemical detection of blood glucose concentration in the sample; the dry fluorescence detection module and the circuit detection module work independently and do not interfere with each other. The dry fluorescence detection module is located on one side of the test reagent product; the dry fluorescence detection module includes: a light source, an aperture, a lens, a filter, and a fluorescence detection sensor; Along a direction perpendicular to the test plane of the test reagent product, the lens, filter and fluorescence detection sensor are sequentially and spaced apart above the test reagent product, with the lens and the test reagent product being adjacent to each other; And / or, the light generated by the light source is obliquely illuminating the test reagent product; The axis formed by the arrangement of the test reagent, lens, filter, and fluorescence detection sensor intersects with the light emitted by the light source. An aperture is also provided along the path of the light generated by the light source.

5. The detection device according to claim 1, characterized in that, The hardware module is used to analyze the detection results and obtain analysis results, including pancreatic islet function index; The display module is used to output the analysis results.

6. The detection device according to claim 1 or 2, characterized in that, The detection device further includes: a communication module; The communication module is connected to the hardware module and is used to output the detection results to the mobile terminal.

7. The detection device according to claim 1 or 2, characterized in that, The reagent products include at least one of the following: test cards, test kits, and test strips; The dual-layer test strip has a dual-layer structure; The double-layer test strip has a top layer for C-peptide and insulin concentration testing, and a bottom layer for blood glucose testing.

8. The detection device according to claim 7, characterized in that, The dual-layer test strip has a dual-layer structure, with the upper layer being a dry fluorescent test strip and the lower layer being an electrochemical test strip; The electrochemical test strip includes an auxiliary electrode, a working electrode, a reference electrode, and an automatic identification electrode; And / or, the test reagent product further includes an upper shell and a lower shell, and the double-layer test strip is located in the cavity formed by assembling the upper shell and the lower shell; The upper shell has a dropper hole for the sample to be tested and a result observation window.

9. A detection method using the detection apparatus according to any one of claims 1-8, characterized in that, Includes the following steps: The sample to be tested is placed on the sample pad of the double-layer test strip to form the test reagent product. Then, the test reagent product is placed in the injection module, and the detection device automatically completes the incubation and detection. Finally, the detection result is displayed on the display screen of the display module. The test results include: C-peptide concentration, insulin concentration, and blood glucose concentration.

10. The detection method according to claim 9, characterized in that, The detection device also transmits the detected C-peptide concentration, insulin concentration, and blood glucose concentration results to a mobile terminal.

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