Transient detection system of biological indicator concentration based on human body fluids

Abstract

The present invention provides a transient detection system for the concentration of biological indicators based on human body fluids, which relates to the technical field of detection systems. The transient detection system for the concentration of biological indicators based on human body fluids includes a highly sensitive electrochemical detector, an enzyme-free reagent kit, and a sample spray pen; the enzyme-free reagent kit includes an enzyme-free three-electrode solid sensor; the highly sensitive electrochemical detector has a self-priming base, the self-priming base is provided with a three-electrode elastic contact, and the three-electrode elastic contact is connected to the signal of the enzyme-free three-electrode solid sensor; the sample spray pen is used to control the sample spray pen to quantitatively absorb or spray human body fluid samples at a constant speed onto the surface of the enzyme-free three-electrode solid sensor, and the highly sensitive electrochemical detector collects transient electrical signals to detect the concentration of biological indicators. The detection system provided by the present invention solves the problems in the prior art that household detectors need to be disinfected with alcohol when taking blood and require microneedle trauma, which is easy to cause wound infection.

Description

Technical Field

[0001] The present invention relates to the technical field of detection systems, and in particular to a transient detection system for biological indicator concentrations based on human body fluids. Background Art

[0002] Diabetes is a hidden disease, and blood glucose monitoring is essential for patients to maintain blood glucose control. The most popular blood glucose testing method currently uses a blood glucose meter to draw blood from the fingertip and then test it using test strips. Severe diabetic patients require fingertip blood draws six or more times a day. Frequent blood sampling can cause pain, wound infection, or other complications. Test strip readings can be affected by user technique, environmental conditions, and test strip quality, resulting in low blood glucose measurement accuracy, which in turn impacts patient treatment decisions and management.

[0003] Uric acid is the end product of the breakdown of purines in nucleic acids in the body, and most of it is excreted through the kidneys. Diet and lifestyle, genetics, medications, and illness can all lead to elevated uric acid levels in the blood, causing conditions like gout. The most popular uric acid testing method currently available in the market involves drawing blood from the fingertips using a detector and measuring it with test strips. Frequent blood sampling, as mentioned above, can lead to pain, wound infections, or other complications. Test strip readings can be affected by user technique, environmental conditions, and test strip quality, resulting in inaccurate blood glucose measurements, which can impact patient treatment decisions and management. Summary of the Invention

[0004] The purpose of the present invention is to provide a transient detection system for the concentration of biological indicators based on human body fluids to solve the technical problems of existing similar product technologies such as the inconvenience of using household detectors for chemical detection methods, low accuracy, poor repeatability and the need for minimally invasive techniques.

[0005] In order to solve the above technical problems, the technical solution provided by the present invention is:

[0006] The present invention provides a transient detection system for biological indicator concentration based on human body fluids, comprising a highly sensitive electrochemical detector, an enzyme-free reagent kit and a sample spray pen;

[0007] The enzyme-free test kit includes a bottle body and a bottle bottom, wherein the bottle bottom is mounted on the bottom of the bottle body and has a non-enzyme three-electrode solid sensor on the surface close to the bottle body and a three-electrode conductive contact on the other surface;

[0008] The highly sensitive electrochemical detector has a self-priming base, the self-priming base is provided with a three-electrode elastic contact, the self-priming base is limitedly matched with the enzyme-free test kit, and the three-electrode elastic contact is connected to the enzyme-free three-electrode solid sensor signal;

[0009] The sample spray pen includes a shell, a control mechanism and a constant-speed and quantitative plunger mechanism. The control mechanism is installed on the shell and is used to control the sample spray pen to quantitatively absorb or constantly spray human body fluid samples onto the surface of the enzyme-free three-electrode solid sensor. The highly sensitive electrochemical detector collects instantaneous electrical signals to detect the concentration of biological indicators; the constant-speed and quantitative plunger mechanism is installed at the end of the sample spray pen.

[0010] Furthermore, the enzyme-free three-electrode solid sensor includes a counter electrode, a working electrode and a reference electrode;

[0011] The counter electrode, the working electrode and the reference electrode are spaced apart.

[0012] Furthermore, the working electrode material is conductive mixed carbon paste; the counter electrode material is conductive carbon paste; and the reference electrode material is conductive silver paste.

[0013] Furthermore, the bottle bottom is installed with a first magnetic component, and the self-priming base is installed with a second magnetic component, and the first magnetic component and the second magnetic component have opposite magnetic properties.

[0014] Furthermore, the bottle bottom is provided with a first axial positioning structure, and the self-priming base is provided with a second rotation positioning structure, and the first axial positioning structure cooperates with the second rotation positioning structure.

[0015] Furthermore, the control mechanism includes a push switch rod, an injection spring, a piston rod and a piston sleeve;

[0016] The push switch rod is installed on the top of the housing, and one end thereof extends into the housing. The piston sleeve is installed in the housing and is spaced apart from the push switch rod.

[0017] A slide groove is provided at the bottom of the push switch rod, the injection spring is located in the slide groove, one end of the piston rod is connected to the injection spring and slides with the slide groove, the piston sleeve is sleeved on the piston rod, and the constant speed and quantitative plunger mechanism is installed at the end.

[0018] Furthermore, the control mechanism further comprises a return spring and an outer sleeve, wherein the outer sleeve is located in the outer shell and is sleeved on the piston sleeve;

[0019] One end of the piston rod extending into the sliding groove is provided with a protrusion, and the outer sleeve is provided with a 7-shaped limiting groove, and the protrusion is inserted into the limiting groove;

[0020] One end of the return spring abuts against the limiting protrusion of the push switch rod, and the other end abuts against the outer sleeve.

[0021] Furthermore, the bottle body includes a bottle body and a bottle cap, one end of the bottle body is connected to the bottle cap, and the other end is connected to the bottle bottom.

[0022] Furthermore, the inner wall of the bottle body is provided with a mounting protrusion, and the lower surface of the mounting protrusion is provided with a mounting groove;

[0023] The bottle bottom is bonded to the lower surface of the mounting protrusion, and the first magnetic member passes through the bottle bottom and is inserted into the mounting groove.

[0024] Furthermore, the bottle body is provided with a third axial positioning structure, and the first axial positioning structure cooperates with the third axial positioning structure.

[0025] Based on the above technical solutions, the technical effects achieved by the present invention are analyzed as follows:

[0026] The present invention provides a transient detection system for the concentration of biological indicators based on human body fluids, which includes a highly sensitive electrochemical detector, an enzyme-free reagent kit and a sample spray pen; the enzyme-free reagent kit includes a bottle body and a bottle bottom, the bottle bottom is installed at the bottom of the bottle body and an enzyme-free three-electrode solid sensor is provided on the surface close to the bottle body, and a three-electrode conductive contact is provided on the other surface; the highly sensitive electrochemical detector has a self-priming base, the self-priming base is provided with a three-electrode elastic contact, the self-priming base is limitedly matched with the enzyme-free reagent kit and the three-electrode elastic contact is connected to the enzyme-free three-electrode solid sensor signal; the sample spray pen includes a shell, a control mechanism and a constant-speed quantitative plunger mechanism, the control mechanism is installed on the shell, and is used to control the sample spray pen to quantitatively absorb or constant-speed spray human body fluid samples to the surface of the enzyme-free three-electrode solid sensor, the highly sensitive electrochemical detector collects transient electrical signals to detect the concentration of biological indicators; the constant-speed quantitative plunger mechanism is installed at the end of the sample spray pen.

[0027] Among them, transient detection is to use a jet pen to spray the body fluid sample to be tested onto the sensor surface at a constant speed, quantity and speed, and collect the instantaneous electrical signal to obtain the corresponding biological indicator concentration.

[0028] The principle of this detection system is: under a certain electrode potential, when a liquid flow containing the analyte (such as blood sugar, uric acid or vitamins, etc.) is sprayed onto the electrode surface at a constant speed and quantity, the analyte will undergo an instantaneous redox reaction on the electrode surface to generate an electrical signal. When the environmental conditions are consistent (liquid flow spray speed, spray dose, spray distance, and solution concentration in the reagent bottle remain unchanged), the electrical signal value is linearly related to the concentration of the analyte, which can be used for quantitative analysis.

[0029] The following uses saliva to test blood glucose and uric acid as an example: a jet pen automatically collects a fixed amount of saliva and sprays it at a fixed rate into a predetermined amount of homemade sample diluent. Simultaneously, a fixed potential is applied to the electrodes, causing the blood glucose and uric acid in the saliva to undergo an instantaneous redox reaction on the enzyme-free three-electrode solid sensor, generating an electrical signal. Under the conditions of maintaining the liquid jet velocity, jet dose, jet distance, and solution concentration in the reagent bottle, the detection system compares the electrical signal values ​​of standard samples of different concentrations of blood glucose and uric acid to develop a standard curve. Based on the electrical signal values ​​generated by the test sample, the blood glucose and uric acid content in the test sample is determined. This detection system can detect the concentrations of blood glucose, uric acid, or both blood glucose and uric acid simultaneously.

[0030] The enzyme-free kit in this detection system is a disposable, portable and pre-packaged kit. It uses an enzyme-free three-electrode solid sensor to detect the concentration of biological indicators. It is easy to use, simple to operate and avoids cross-contamination. While achieving high sensitivity and convenience, it avoids the complex enzyme reaction steps in traditional methods and overcomes the shortcomings of microneedle trauma detection methods.

[0031] The sample spray pen in this detection system has a simple and compact structure. It can take micro-samples with one hand and spray and add samples quickly, at a constant speed, quantitatively and evenly to achieve transient detection. Compared with existing static detection, transient detection has high sensitivity and good reproducibility. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the specific embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0033] Figure 1 A schematic diagram of the structure of a transient detection system for biological indicator concentrations based on human body fluids provided by an embodiment of the present invention;

[0034] Figure 2 A schematic structural diagram of a highly sensitive electrochemical detector in a detection system provided by an embodiment of the present invention;

[0035] Figure 3 for Figure 2 A partial enlarged view of point A in the middle;

[0036] Figure 4 A schematic structural diagram of an enzyme-free kit in a detection system provided in an embodiment of the present invention;

[0037] Figure 5A schematic diagram of the internal structure of the enzyme-free kit in the detection system provided in an embodiment of the present invention;

[0038] Figure 6 Schematic diagram of the bottle bottom structure in the detection system provided by the embodiment of the present invention Figure 1 ;

[0039] Figure 7 Schematic diagram of the bottle bottom structure in the detection system provided by the embodiment of the present invention Figure 2 ;

[0040] Figure 8 A schematic diagram of the structure of a bottle body in a detection system provided by an embodiment of the present invention;

[0041] Figure 9 A schematic diagram of the structure of a bottle cap in a detection system provided by an embodiment of the present invention;

[0042] Figure 10 Schematic diagram of the structure of the sample spray pen in the detection system provided by the embodiment of the present invention Figure 1 ;

[0043] Figure 11 Schematic diagram of the structure of the sample spray pen in the detection system provided by the embodiment of the present invention Figure 2 ;

[0044] Figure 12 Schematic diagram of the structure of the sample spray pen in the detection system provided by the embodiment of the present invention Figure 3 .

[0045] icon:

[0046] 100 - Highly sensitive electrochemical detector; 110 - Self-priming base; 111 - Three-electrode elastic contact; 112 - Second magnetic member; 113 - Second positioning plane; 120 - Display unit; 130 - Switch; 140 - Switch button; 150 - Charging port;

[0047] 200 - Enzyme-free reagent kit; 210 - Bottle bottom; 211 - Enzyme-free three-electrode solid sensor; 212 - Counter electrode; 213 - Working electrode; 214 - Reference electrode; 215 - Three-electrode conductive contact; 216 - First magnetic member; 217 - First positioning plane; 220 - Bottle body; 221 - Mounting protrusion; 222 - Mounting groove; 223 - Third positioning plane; 230 - Bottle cap; 231 - Operating unit; 232 - Anti-slip structure; 233 - Connecting unit; 240 - Centering device;

[0048] 300 - sample spray pen; 310 - housing; 320 - constant speed and quantitative plunger mechanism; 330 - push switch rod; 331 - slide groove; 332 - limit protrusion; 340 - injection spring; 350 - piston rod; 351 - protrusion; 360 - piston sleeve; 370 - return spring; 380 - outer sleeve; 381 - limit groove. DETAILED DESCRIPTION

[0049] To make the objectives, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Generally, the components of the embodiments of the present invention described and shown in the drawings herein can be arranged and designed in various different configurations.

[0050] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the invention as claimed, but rather merely represents selected embodiments of the present invention. All other embodiments derived by persons of ordinary skill in the art based on the embodiments of the present invention without creative effort shall fall within the scope of protection of the present invention.

[0051] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, it does not need to be further defined or explained in subsequent drawings.

[0052] In the description of the present invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer" and the like indicate positions or locations based on the positions shown in the accompanying drawings, or the positions or locations in which the inventive product is typically placed when in use. These terms are intended solely to facilitate the description of the present invention and to simplify the description, and are not intended to indicate or imply that the devices or components referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on the present invention. Furthermore, the terms "first," "second," and "third," etc., are used solely to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0053] Furthermore, terms such as "horizontal," "vertical," and "overhanging" do not necessarily imply that a component must be absolutely horizontal or overhanging, but rather that it can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal than "vertical," and does not mean that the structure must be completely horizontal, but rather that it can be slightly tilted.

[0054] In the description of the present invention, it should also be noted that, unless otherwise expressly specified or limited, the terms "disposed," "installed," "connected," and "connected" should be understood in a broad sense. For example, they may refer to fixed connections, detachable connections, or integral connections; they may refer to mechanical connections or electrical connections; they may refer to direct connections or indirect connections through an intermediate medium; and they may refer to internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on the specific circumstances.

[0055] The following embodiments of the present invention are described in detail with reference to the accompanying drawings. In the absence of conflict, the following embodiments and features in the embodiments may be combined with each other.

[0056] The transient detection system for the concentration of biological indicators based on human body fluids provided in an embodiment of the present invention includes a highly sensitive electrochemical detector 100, an enzyme-free reagent kit 200, and a sample spray pen 300; the enzyme-free reagent kit 200 includes a bottle body and a bottle bottom 210, the bottle bottom 210 is installed at the bottom of the bottle body and has a non-enzyme three-electrode solid sensor 211 on the surface close to the bottle body, and a three-electrode conductive contact 215 on the other surface; the highly sensitive electrochemical detector 100 has a self-priming base 110, the self-priming base 110 is provided with a three-electrode elastic contact 111, the self-priming base 110 It is limitedly matched with the enzyme-free test kit 200 and the three-electrode elastic contact 111 is signal-connected to the enzyme-free three-electrode solid sensor 211; the sample injection pen 300 includes a shell 310, a control mechanism and a constant-speed quantitative plunger mechanism 320. The control mechanism is installed on the shell 310 and is used to control the sample injection pen 300 to quantitatively absorb or constant-speed spray saliva samples to the surface of the enzyme-free three-electrode solid sensor 211. The highly sensitive electrochemical detector 100 collects instantaneous electrical signals to detect the concentration of biological indicators; the constant-speed quantitative plunger mechanism 320 is installed at the end of the sample injection pen 300.

[0057] Specifically, see Figures 1 to 3The highly sensitive electrochemical detector 100 includes a housing, an electrical signal processing unit, a display unit 120, a switch 130, a toggle button 140, and a charging port 150. The electrical signal processing unit is located within the housing and is signal-connected to the display unit 120, the switch 130, the toggle button 140, and the three-electrode elastic contact 111 to send activation signals or receive information. The electrical signal processing unit includes a microprocessor chip, which may have its own memory unit or be implemented in conjunction with an external memory unit. The electrical signal processing unit pre-stores a salivary blood glucose / uric acid reference table that records the correlation between multiple blood glucose / uric acid values ​​and electrochemical parameters obtained by the electrical signal processing unit. When the electrical signal processing unit receives the electrochemical parameters, it can provide the blood glucose / uric acid value based on the salivary blood glucose / uric acid reference table. When the electrical signal processing unit receives the corrected blood glucose value and the electrochemical parameter, it can calibrate the salivary blood glucose / uric acid reference table based on the three aforementioned parameters. The display unit 120 is embedded in the housing and connected to the electrical signal processing unit to display the test value. The electrical signal processing unit is powered by a 5V USB port, which can be powered by a common computer USB port. The charging port 150 can be used to connect to external devices to transmit information.

[0058] Among them, transient detection is to use a jet pen to spray the body fluid sample to be tested onto the sensor surface at a constant speed, quantity and speed, and collect the instantaneous electrical signal to obtain the corresponding biological indicator concentration.

[0059] The principle of this detection system is: under a certain electrode potential, when a liquid flow containing the analyte (such as blood sugar, uric acid or vitamins, etc.) is sprayed onto the electrode surface at a constant speed and quantity, the analyte will undergo an instantaneous redox reaction on the electrode surface to generate an electrical signal. When the environmental conditions are consistent (liquid flow spray speed, spray dose, spray distance, and solution concentration in the reagent bottle remain unchanged), the electrical signal value is linearly related to the concentration of the analyte, which can be used for quantitative analysis.

[0060] The enzyme-free test kit 200 in this detection system is a disposable, portable, pre-packaged test kit that utilizes an enzyme-free three-electrode solid-state sensor 211 to detect biomarker concentrations. It is easy to use, simple to operate, and avoids cross-contamination. While achieving high sensitivity and convenience, it avoids the complex enzymatic reaction steps of traditional methods, overcoming the shortcomings of microneedle invasive detection methods. The sample spray pen 300 in this detection system is simple and compact, allowing for single-handed microsampling. It delivers rapid, constant, quantitative, and uniform spraying, enabling transient detection. Compared to existing static detection, transient detection offers higher sensitivity and better reproducibility.

[0061] The following examples illustrate the difference between transient detection and static detection:

[0062] 1) Minimum detectable concentration test: Take a glucose standard with a concentration of 5 μmol / L and measure it using the static detection method and the transient detection method respectively. Repeat the measurement three times. The results are shown in Table 1:

[0063]

[0064] Table 1

[0065] 2) Sample analysis linearity test: Glucose standards with concentrations of 5, 10, 20, 50, 100, and 200 μmol / L were measured using the static detection method and the transient detection method, respectively. Each concentration was tested once. The linear regression equation was obtained using the theoretical concentration as the independent variable and the current as the dependent variable, and the linear correlation coefficient r was calculated. The results are shown in Table 2:

[0066]

[0067] Table 2

[0068] 3) Repeatability test: A glucose standard with a concentration of 50 μmol / L was measured using the static detection method and the transient detection method, and the measurement was repeated 10 times. The results are shown in Table 3:

[0069]

[0070] Table 3

[0071] Based on the above test results, we can know that:

[0072] 1) The minimum measurable concentration of transient detection is 5 μmol / L, which is lower than the minimum measurable concentration of static detection of 10 μmol / L, indicating that the sensitivity of transient detection is higher than that of static detection.

[0073] 2) The linear correlation coefficient of transient detection is 0.9978, which is larger than the linear correlation coefficient of static detection 0.9955, indicating that the linear correlation of transient detection is better.

[0074] 3) The reproducibility of transient detection is 3.88%, which is lower than the reproducibility of static detection (5.42%), indicating that the reproducibility of transient detection is good.

[0075] The shape and structure of the highly sensitive electrochemical detector 100 are described in detail below:

[0076] In an optional solution of the embodiment of the present invention, the self-priming base 110 is installed with a second magnetic member 112 , which has opposite magnetic properties to the first magnetic member 216 of the bottle bottom 210 .

[0077] Specifically, in this embodiment, two second magnetic members 112 are provided, and correspondingly, two first magnetic members 216 are provided; because the first magnetic members 216 and the second magnetic members 112 have opposite magnetic properties, the first magnetic members 216 and the second magnetic members 112 attract and cooperate with each other, thereby stably mounting the bottle base 210 within the self-priming base 110. Furthermore, both the first magnetic member 216 and the second magnetic member 112 are configured as magnetic iron columns and have equal diameters.

[0078] The first magnetic member 216 and the second magnetic member 112 cooperate with each other by magnetic attraction, so that the bottom of the enzyme-free reagent kit 200 can be stably installed on the high-sensitivity electrochemical detector 100 .

[0079] In an optional solution of the embodiment of the present invention, the bottle bottom 210 is provided with a first axial positioning structure, and the self-priming base 110 is provided with a second rotation positioning structure, and the first axial positioning structure cooperates with the second rotation positioning structure.

[0080] Specifically, the bottle bottom 210 is set to be circular, the first axial positioning structure is set on the side wall of the bottle bottom 210 and is set to the first positioning plane 217; the self-priming base 110 is correspondingly set to be circular, and the second rotational positioning structure is set on the inner wall of the self-priming base 110 and is set to the second positioning plane 113. The first positioning plane 217 and the second positioning plane 113 are fitted together to realize the positioning of the enzyme-free reagent kit 200.

[0081] The first positioning plane 217 and the second positioning plane 113 prevent the enzyme-free reagent kit 200 from being installed in the wrong direction, thereby improving installation efficiency.

[0082] In an optional embodiment of the present invention, the highly sensitive electrochemical detector 100 is configured in a substantially rectangular shape. A self-priming base 110, a display unit 120, a switch 130, and a toggle button 140 are spaced apart on the top surface. A charging port 150 is provided on the side wall. The overall structure is simple and compact, making it easy to use.

[0083] The structure and shape of the enzyme-free kit 200 are described in detail below:

[0084] In the optional solutions of the embodiments of the present invention, please refer to Figures 4 to 9 The enzyme-free three-electrode solid sensor 211 includes a counter electrode 212, a working electrode 213 and a reference electrode 214; the counter electrode 212, the working electrode 213 and the reference electrode 214 are arranged at intervals.

[0085] Specifically, the enzyme-free test kit 200 can detect blood glucose concentration alone, uric acid concentration alone, or both simultaneously; of course, the kit can also detect the concentrations of other biological indicators. Furthermore, the bottle base 210 is configured as a circuit board substrate with printed electrodes, although this is not limited to a circuit board substrate. The circuit board is provided with a non-enzymatic three-electrode solid sensor 211. The three-electrode conductive contacts 215 at the bottom of the bottle base 210 are used to connect to a highly sensitive electrochemical detector 100 and output a signal to the highly sensitive electrochemical detector 100. In this embodiment, the thickness of the bottle base 210 is set to 1.6 mm. Preferably, the bottle body 220 is made of medical-grade PP. The non-enzymatic three-electrode solid sensor 211 is prepared by first preparing nanoparticles of suitable size and surface modification, then combining the nanoparticles with an electrochemical sensor to form the non-enzymatic three-electrode solid sensor 211 capable of measuring blood glucose or uric acid. Furthermore, the nanoparticles can be selected from metal nanoparticles (Au, Ag, Pt nanoparticles), carbon-based nanomaterials (graphene, carbon nanotubes, carbon dots, fullerenes), metal oxide semiconductor materials (black TiO2, Fe3O4), metal sulfides (MoS2), etc.; the modification of the nanoparticles can be selected from: amino acid-mediated surface modification, thiol-mediated surface modification, ligand exchange-based surface modification, etc.; or, MXene materials can be used instead of nanoparticles, and MXene materials include Ti3C2, Ti2C, Nb2C, V2C, Mo2C, etc.; or, magnetic particles or magnetic beads, such as silica gel-coated magnetic beads, can be used. Of course, other materials and modification types should also be within the scope of protection of the embodiments of the present invention as long as the size meets the requirements and the requirements of excellent electrical performance are met. In this embodiment, the material of the working electrode 213 is a conductive mixed carbon paste; the material of the counter electrode 212 is a conductive carbon paste; and the material of the reference electrode 214 is a conductive silver paste. Furthermore, the counter electrode 212 is configured to be arc-shaped, the working electrode 213 and the reference electrode 214 are both configured to be circular, and the diameter of the working electrode 213 is larger than the diameter of the reference electrode 214; of course, the shapes and arrangements of the counter electrode 212, the working electrode 213 and the reference electrode 214 are not limited to the forms described above, and other shapes and arrangements should also be within the protection scope of the embodiments of the present invention.

[0086] The counter electrode 212 , the working electrode 213 and the reference electrode 214 realize the redox effect of the enzyme-free three-electrode solid sensor 211 on the human body fluid sample.

[0087] In an optional solution of the embodiment of the present invention, the bottle body includes a bottle body 220 and a bottle cap 230 , one end of the bottle body 220 is connected to the bottle cap 230 , and the other end is connected to the bottle bottom 210 .

[0088] Specifically, see Figure 8The bottle body 220 is configured as a hollow columnar structure, and the bottle cap 230 and the bottle bottom 210 are respectively connected to both ends of the bottle body 220 .

[0089] In an optional solution of an embodiment of the present invention, the inner wall of the bottle body 220 is provided with a mounting protrusion 221, and the lower surface of the mounting protrusion 221 is provided with a mounting groove 222; the bottle bottom 210 is bonded to the lower surface of the mounting protrusion 221, and the first magnetic part 216 passes through the bottle bottom 210 and is inserted into the mounting groove 222.

[0090] Specifically, see Figure 8 The mounting protrusion 221 protrudes toward the interior of the bottle body 220 ; and two first magnetic members 216 and two mounting grooves 222 are provided.

[0091] The bottom 210 is bonded to the lower surface of the mounting protrusion 221, increasing the contact area between the bottom 210 and the bottle body 220 and strengthening the connection between the two, thereby preventing the bottom 210 from falling off the bottle body 220. The two first magnetic members 216 are respectively inserted into the two mounting grooves 222 to achieve the connection between the first magnetic members 216 and the bottle body 220.

[0092] In an optional solution of the embodiment of the present invention, the bottle body 220 is provided with a third axial positioning structure, and the first axial positioning structure cooperates with the third axial positioning structure.

[0093] Specifically, the bottle body 220 is configured as a cylinder, the third axial positioning structure is provided on the bottle body 220 and is provided as a first positioning plane 217; the bottle bottom 210 is configured as a circle, the first axial positioning structure is provided on the outer wall of the bottle bottom 210 and is provided with a second positioning plane 113, the first positioning plane 217 is in contact with the third positioning plane 223, thereby achieving the positioning effect on the bottle bottom 210 and preventing the bottle bottom 210 from being in the wrong direction when being installed on the bottle body 220.

[0094] The first positioning plane 217 and the third positioning plane 223 prevent the bottle bottom 210 from being installed in the wrong direction to the bottle body 220, thereby improving installation efficiency.

[0095] In an optional solution of the embodiment of the present invention, the two mounting grooves 222 are symmetrically arranged.

[0096] Specifically, the symmetry lines of the two mounting grooves 222 are perpendicular to the third positioning plane 223 .

[0097] The two mounting grooves 222 are symmetrically arranged, so that the two first magnetic members 216 are symmetrically arranged, which helps to stably install the bottom of the enzyme-free reagent kit 200 on the high-sensitivity electrochemical detector 100 .

[0098] In an optional solution of the embodiment of the present invention, the bottle cap 230 is threadedly connected to the bottle body 220.

[0099] Specifically, the bottle cap 230 is provided with an external thread, and the inner wall of the top of the bottle body 220 is provided with an internal thread, and the external thread of the bottle cap 230 is threadedly connected to the internal thread of the bottle body 220.

[0100] The bottle cap 230 is threadedly connected to the bottle body 220 , making it easy to install and remove the bottle cap 230 .

[0101] In an optional solution of the embodiment of the present invention, the bottle cap 230 includes an operating portion 231 and a connecting portion 233 , the operating portion 231 is connected to the connecting portion 233 , and the connecting portion 233 is threadedly connected to the bottle body 220 ; an outer wall of the operating portion 231 is provided with an anti-slip structure 232 .

[0102] Specifically, see Figure 9 The anti-slip structure 232 includes multiple grooves spaced apart along the circumference of the operating portion 231, each extending axially along the operating portion 231. Furthermore, a sealing rubber pad is provided in the middle of the operating portion 231. The bottle cap 230 is made of PVC. A sealing ring is provided around the outer periphery of the connecting portion 233 to prevent liquid leakage from the bottle cap 230.

[0103] The anti-slip structure 232 helps to increase the friction between the bottle cap 230 and the operator's hand when installing or removing the bottle cap 230, thereby facilitating unscrewing or tightening the bottle cap 230.

[0104] In an optional solution of the embodiment of the present invention, a centering device 240 is installed in the bottle body 220 .

[0105] Specifically, the centering device 240 is fixed at the middle position of the bottle body 220, and the axis of the centering device 240 is collinear with the axis of the bottle body 220. Preferably, the centering device 240 is made of medical PP material.

[0106] The centering device 240 is used to ensure that the sample spray pen 300 is accurately aligned with the center after being inserted into the bottle body 220 .

[0107] The structure and shape of the sample jet pen 300 are described in detail below:

[0108] In the optional solutions of the embodiments of the present invention, please refer to Figures 10 to 12The control mechanism includes a push switch rod 330, an injection spring 340, a piston rod 350 and a piston sleeve 360; the push switch rod 330 is installed on the top of the shell 310, and one end extends into the shell 310, and the piston sleeve 360 ​​is installed in the shell 310 and is spaced apart from the push switch rod 330; a slide groove 331 is provided at the bottom of the push switch rod 330, and the injection spring 340 is located in the slide groove 331, one end of the piston rod 350 is connected to the injection spring 340 and slides with the slide groove 331, the piston sleeve 360 ​​is sleeved on the piston rod 350, and a constant speed and quantitative plunger mechanism 320 is installed at the end. The control mechanism also includes a return spring 370 and an outer sleeve 380. The outer sleeve 380 is located in the outer shell 310 and is sleeved on the piston sleeve 360. The end of the piston rod 350 extending into the slide groove 331 is provided with a protrusion 351, and the outer sleeve 380 is provided with a 7-shaped limiting groove 381, and the protrusion 351 is inserted into the limiting groove 381. One end of the return spring 370 abuts against the limiting protrusion 332 of the press switch rod 330, and the other end abuts against the outer sleeve 380.

[0109] Specifically, the outer wall of the push-button switch rod 330 is provided with a limiting protrusion 332, and the bottom is provided with a sliding groove 331. The push-button switch rod 330 has a switching function for sucking or spraying liquid. When the push-button switch rod 330 is pressed and raised for the first time, the sample is sucked into the sample spray pen 300. When the push-button switch rod 330 is pressed a second time, the sample is sprayed quickly, at a constant speed, and evenly onto the electrode plate via the constant-speed and quantitative plunger mechanism 320. By changing the inner diameter of the piston rod 350 and the piston sleeve 360 ​​that cooperates with the piston rod 350, the amount of suction can be quantitatively controlled. By changing the size of the limiting groove 381, the amount of spray can be quantitatively controlled. The spray speed is determined by the elastic potential energy of the injection spring 340. By changing the elastic potential energy of the spray speed, the sample spray speed can be changed. The housing 310 is designed in a pen-like shape for easy use, portability, and storage.

[0110] The sample jet pen 300 realizes the function of jetting biological samples while achieving the effects of microquantity, constant speed and rapid jetting, and provides a guarantee for the consistency of the amount of biological samples extracted for testing.

[0111] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the above embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements 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 transient detection system for biological indicator concentration based on human body fluids, characterized in that: include: A highly sensitive electrochemical detector (100), an enzyme-free reagent kit (200), and a sample spray pen (300); The enzyme-free test kit (200) comprises a bottle body and a bottle bottom (210), wherein the bottle bottom (210) is mounted on the bottom of the bottle body and has a surface close to the bottle body provided with an enzyme-free three-electrode solid sensor (211), and another surface provided with a three-electrode conductive contact (215); the enzyme-free three-electrode solid sensor (211) comprises nanoparticles, and the nanoparticles are configured as metal nanoparticles or metal oxide semiconductor materials; The highly sensitive electrochemical detector (100) has a self-priming base (110), the self-priming base (110) is provided with three-electrode elastic contacts (111), the self-priming base (110) and the enzyme-free reagent kit (200) are positionally matched, and the three-electrode elastic contacts (111) are connected to the three-electrode conductive contacts (215); The sample spray pen (300) includes a housing (310), a control mechanism and a constant-speed quantitative plunger mechanism (320). The control mechanism is installed on the housing (310) and is used to control the sample spray pen (300) to quantitatively absorb or constant-speed spray human body fluid samples onto the surface of the enzyme-free three-electrode solid sensor (211). The high-sensitivity electrochemical detector (100) collects instantaneous electrical signals to detect the concentration of biological indicators; the constant-speed quantitative plunger mechanism (320) is installed at the end of the sample spray pen (300).

2. The system for transient detection of biological indicator concentration based on human body fluids according to claim 1, characterized in that: The enzyme-free three-electrode solid sensor (211) includes a counter electrode (212), a working electrode (213) and a reference electrode (214); The counter electrode (212), the working electrode (213) and the reference electrode (214) are arranged at intervals.

3. The system for transient detection of biological indicator concentration based on human body fluids according to claim 2, characterized in that: The material of the working electrode (213) is a conductive mixed carbon paste; the material of the counter electrode (212) is a conductive carbon paste; and the material of the reference electrode (214) is a conductive silver paste.

4. The system for transient detection of biological indicator concentration based on human body fluids according to claim 1, characterized in that: The bottle bottom (210) is installed with a first magnetic member (216), and the self-priming base (110) is installed with a second magnetic member (112), and the first magnetic member (216) and the second magnetic member (112) have opposite magnetic properties.

5. The system for transient detection of biological indicator concentration based on human body fluids according to claim 1, characterized in that: The bottle bottom (210) is provided with a first axial positioning structure, and the self-priming base (110) is provided with a second rotation positioning structure, wherein the first axial positioning structure cooperates with the second rotation positioning structure.

6. The system for transient detection of biological indicator concentration based on human body fluids according to claim 1, characterized in that: The control mechanism comprises a pressing switch rod (330), an injection spring (340), a piston rod (350) and a piston sleeve (360); The push switch rod (330) is installed on the top of the housing (310), and one end thereof extends into the housing (310); the piston sleeve (360) is installed in the housing (310) and is spaced apart from the push switch rod (330); A slide groove (331) is provided at the bottom of the push switch rod (330), the injection spring (340) is located in the slide groove (331), one end of the piston rod (350) is connected to the injection spring (340) and slidably cooperates with the slide groove (331), the piston sleeve (360) is sleeved on the piston rod (350), and the fixed-speed and fixed-quantity plunger mechanism (320) is installed at the end.

7. The system for transient detection of biological indicator concentration based on human body fluids according to claim 6, characterized in that: The control mechanism further includes a return spring (370) and an outer sleeve (380), wherein the outer sleeve (380) is located within the outer shell (310) and is sleeved on the piston sleeve (360); One end of the piston rod (350) extending into the sliding groove (331) is provided with a protrusion (351), and the outer sleeve (380) is provided with a 7-shaped limiting groove (381), and the protrusion (351) is inserted into the limiting groove (381); One end of the return spring (370) abuts against the limiting protrusion (332) of the push switch rod (330), and the other end abuts against the outer sleeve (380).

8. The system for transient detection of biological indicator concentration based on human body fluids according to claim 1, characterized in that: The bottle body comprises a bottle body (220) and a bottle cap (230); one end of the bottle body (220) is connected to the bottle cap (230), and the other end is connected to the bottle bottom (210).

9. The system for transient detection of biological indicator concentration based on human body fluids according to claim 8, characterized in that: The inner wall of the bottle body (220) is provided with a mounting protrusion (221), and the lower surface of the mounting protrusion (221) is provided with a mounting groove (222); The bottle bottom (210) is bonded to the lower surface of the mounting protrusion (221), and the first magnetic member (216) passes through the bottle bottom (210) and is inserted into the mounting groove (222).

10. The system for transient detection of biological indicator concentration based on human body fluids according to claim 8, characterized in that: The bottle body (220) is provided with a third axial positioning structure, and the first axial positioning structure cooperates with the third axial positioning structure.

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