A constant temperature shaking incubator for immunoassay kits and a method for adjusting the shaking frequency thereof

Abstract

The present application relates to a kind of constant temperature shaking incubator for immunodetection kit and its shaking frequency adjusting method, belong to immunological analysis equipment technical field, including box, constant temperature module, shaking platform, drive mechanism and control system, still include: online temperature detection unit, set in the inside of box, for real-time acquisition kit current temperature signal;And optical detection unit, set in the above of shaking platform, for real-time monitoring the turbidity or light transmittance change of reaction liquid in kit, target temperature-time curve and target turbidity-time curve are built in control system, for receiving the feedback signal of online temperature detection unit and optical detection unit.In the present application, it solves the problem that traditional incubation equipment cannot dynamically adjust the shaking frequency according to the reaction process, leading to low reaction efficiency and large batch difference, significantly improves the sensitivity, specificity and result consistency of immunodetection.

Description

Technical Field

[0001] This invention relates to the field of immunoassay equipment technology, and in particular to a constant temperature shaking incubator for an immunoassay kit and a method for adjusting the shaking frequency thereof. Background Technology

[0002] Immunological assays, such as enzyme-linked immunosorbent assays (ELISA) and chemiluminescent immunoassays (CLIA), are core technologies widely used in clinical diagnostics and biological research. These assays typically involve the specific binding reaction of antigens and antibodies on a liquid or solid-phase surface. To ensure a complete, homogeneous reaction and achieve the desired binding efficiency, the incubation process is crucial. A constant-temperature shaking incubator provides a constant temperature and a uniform mixing environment for the reagent kits, making it a key device for ensuring the accuracy and reproducibility of immunoassay results.

[0003] Existing immunoassay incubation equipment has the following shortcomings in practical applications:

[0004] First, it lacks a closed-loop oscillation regulation function based on the reaction process. Traditional incubators typically use a fixed oscillation frequency (such as constant oscillation at 300 rpm), which cannot be dynamically adjusted according to the kinetic process of the antigen-antibody binding reaction. In the early stages of the reaction, an excessively high oscillation frequency may damage the antibody coating on the solid phase surface, while in the later stages of the reaction, a fixed oscillation frequency is insufficient to effectively break the diffusion boundary layer, resulting in a decrease in the probability of reactant collisions, low reaction efficiency, and long reaction time.

[0005] Second, the reaction status cannot be monitored in real time. Existing equipment relies on fixed times and temperatures set by operators and cannot sense dynamic parameters reflecting the degree of binding, such as turbidity and transmittance within the reaction solution. When differences in activity between different batches of reagent kits or changes in reaction rates due to environmental factors occur, adaptive adjustments cannot be made, resulting in large batch-to-batch variations and poor consistency in test results.

[0006] Third, in the later stages of the reaction, diffusion limitation becomes the main bottleneck. The antigen-antibody binding rate is determined by the molecular diffusion rate. Continuous constant oscillations cannot effectively enhance mass transfer and easily form a "plateau." Even if the incubation time is extended, the signal value is difficult to increase, affecting the detection sensitivity and the detection rate of low-concentration samples.

[0007] Therefore, developing a constant-temperature oscillation incubation device that can monitor the reaction process online and dynamically adjust the oscillation frequency, especially actively enhancing mass transfer in the later stages of the reaction, is of great significance for improving the sensitivity of immunoassay, shortening the detection time, and enhancing the stability of results. Summary of the Invention

[0008] This invention provides a constant temperature shaking incubator for an immunoassay kit and a method for adjusting the shaking frequency thereon, which solves the problems mentioned in the background art above. It aims to achieve precise closed-loop control of temperature and mixing state during the immunoassay process, thereby improving reaction efficiency and the stability of detection results.

[0009] The present invention provides the following solution to the above-mentioned technical problems: a constant temperature shaking incubator for an immunoassay kit, comprising a box body, a constant temperature module, a shaking platform, a driving mechanism, and a control system. The incubator also includes an online temperature detection unit and an optical detection unit.

[0010] The online temperature detection unit is located inside the enclosure and is used to collect the current temperature signal of the reagent kit in real time and transmit it to the control system. This design can continuously monitor temperature changes without contacting the reagent kit, providing a real-time and accurate data foundation for closed-loop control and avoiding the risk of contamination that may be caused by contact sensors.

[0011] The optical detection unit is positioned above the oscillation platform and is used to monitor changes in the turbidity or transmittance of the reaction liquid in the reagent kit in real time, and transmit the signal to the control system. This structure enables the system to directly sense the immune response process and provides core feedback for dynamically adjusting the oscillation strategy.

[0012] The control system incorporates target temperature-time and target turbidity-time curves to receive feedback signals from the online temperature detection unit and the optical detection unit. Based on PID control or fuzzy control algorithms, it adjusts the heating power of the isothermal module, the oscillation frequency of the drive mechanism, and the oscillation amplitude, respectively, so that the actual temperature and mixing state of the reaction system change along the target temperature-time and target turbidity-time curves. Through this control method, the system can dynamically adjust the oscillation parameters according to the actual binding of the reaction liquid, realizing the transformation from passive isothermal and constant-speed oscillation to active adaptive dynamic regulation, which significantly improves the sensitivity and consistency of immunoassay.

[0013] Furthermore, the online temperature detection unit uses an infrared temperature sensor to detect the temperature of the reagent kit surface in real time in a non-contact manner. This setup enables high-frequency and high-precision temperature measurement without contact with the reagent kit, avoiding potential contamination caused by contact between the sensor and the reagent kit. It is particularly suitable for immunoassay scenarios with high cleanliness requirements.

[0014] Furthermore, the optical detection unit includes a light source and a photoelectric sensor, which are positioned opposite each other above the oscillation platform so that the detection light path passes perpendicularly through the transparent reaction hole of the reagent kit. This structure can directly measure the change in absorbance or transmittance of the reaction solution at a specific wavelength, reflecting the amount of antigen-antibody complex formed in real time, and providing a direct and effective feedback signal for the control strategy.

[0015] Furthermore, the drive mechanism includes an eccentric wheel motor and a connecting rod. One end of the connecting rod is connected to the eccentric wheel motor, and the other end is connected to the oscillation platform. By adjusting the speed and eccentricity of the eccentric wheel motor, the oscillation frequency can be continuously adjusted within the range of 50-500 rpm, and the oscillation amplitude can be continuously adjusted within the range of 1-10 mm. This structure can precisely adjust the oscillation frequency and amplitude according to the instructions of the control system, providing an execution basis for realizing multi-mode and multi-stage oscillation strategies.

[0016] Furthermore, the constant temperature module includes a semiconductor cooling chip, a heat sink, and a temperature controller. The semiconductor cooling chip is attached to the inner wall of the chamber and switches between heating and cooling functions by changing the direction of the current, thereby controlling the temperature inside the chamber between 25℃ and 45℃. This structure has a fast response speed and high temperature control accuracy, which can meet the strict temperature requirements of the immune response.

[0017] The present invention also provides a method for adjusting the oscillation frequency of an immunoassay kit based on the above system, comprising the following steps:

[0018] S1: Loading stage, the immunoassay kit to be incubated is placed on the shaking platform and fixed;

[0019] S2: During the preheating and premixing stage, the control system activates the constant temperature module and drive mechanism to raise the temperature inside the chamber to the preset initial incubation temperature, and at the same time premixes the reagent kit with a preset initial oscillation frequency and amplitude, with the initial oscillation frequency being 200-300 rpm.

[0020] S3: Online monitoring and main reaction stage, the online temperature detection unit and optical detection unit monitor the temperature of the reagent kit and the turbidity of the reaction liquid in real time, and the control system dynamically adjusts the oscillation frequency and oscillation amplitude according to the deviation between the real-time turbidity and the preset target turbidity-time curve;

[0021] S4: Frequency optimization and reaction acceleration stage. When the turbidity change rate of the reaction liquid is lower than the preset first threshold, the control system determines that the reaction has entered the plateau period and starts the frequency adjustment strategy to increase the oscillation frequency in an intermittent pulse oscillation mode to promote antigen-antibody binding, while maintaining the heating power of the constant temperature module to prevent temperature fluctuations.

[0022] S5: In the final reaction stage, when the rate of change of turbidity of the reaction liquid drops to the preset second threshold, the control system will reduce the oscillation frequency to the initial value and maintain a constant temperature until the turbidity of the reaction liquid reaches the target final value.

[0023] S6: End reading, stop oscillation, maintain constant temperature, and have the final signal value of the reagent kit read by an external detection device.

[0024] This method introduces multi-stage, refined control of the immune reaction, including preheating, main reaction, acceleration, and final reaction. In particular, it utilizes optical feedback to actively employ pulse oscillation to enhance mass transfer in the later stages of the reaction. This effectively solves the plateau problem caused by diffusion limitations in traditional processes, allowing the antigen-antibody binding reaction to proceed more fully. As a result, the incubation time is shortened while maintaining detection sensitivity.

[0025] Furthermore, in step S4, the oscillation frequency of the driving mechanism is adjusted according to the real-time change rate of turbidity in the reaction liquid: when the turbidity change rate is less than the preset lower limit, the oscillation frequency is increased or intermittent high-frequency pulse oscillation is used to break the diffusion boundary layer and accelerate the collision of reactants; when the turbidity change rate is greater than the preset upper limit, the oscillation frequency is reduced to avoid shearing damage to the formed antigen-antibody complex. This adjustment method establishes a dynamic oscillation mechanism based on reaction kinetics, so that the oscillation intensity matches the reactant binding requirements, avoiding excessive shearing or insufficient mass transfer that may be caused by a fixed oscillation mode, and further improving the accuracy of control.

[0026] Furthermore, in steps S3 to S5, the incubation temperature is controlled between 35℃ and 40℃, the oscillation frequency is controlled between 50 and 500 rpm, and the overall incubation time is 15 to 60 minutes. This parameter range covers the incubation conditions of mainstream immunoassays, ensuring both the specificity and efficiency of antigen-antibody binding and the detection throughput, and has good process adaptability.

[0027] Furthermore, the preset first threshold is 20%-30% of the maximum change rate of turbidity in the reaction solution, the preset second threshold is 5%-10% of the maximum change rate of turbidity in the reaction solution, and the target final value is the average value of the stable fluctuations after the turbidity of the reaction solution reaches the plateau period. The setting of this threshold is based on the typical kinetic curve of the immune response. When the reaction enters the diffusion-limited stage, the enhanced mass transfer intervention is initiated, and the intervention is withdrawn when the reaction is basically completed, forming a reasonable process connection and ensuring the stability and accuracy of the final signal value.

[0028] The beneficial effects of this invention are as follows: This invention provides a constant temperature shaking incubator for an immunoassay kit and a method for adjusting the shaking frequency thereon, which has the following advantages:

[0029] 1. Achieve closed-loop precise control of the reaction process. The optical detection unit acquires real-time data on the turbidity change of the reaction liquid. Combined with the control system, the oscillation frequency and amplitude are dynamically adjusted to ensure that the reaction process proceeds according to the preset kinetic curve. This avoids problems such as insufficient reaction or excessive shearing caused by fixed oscillation parameters, and significantly improves the repeatability of the detection results.

[0030] 2. An active oscillation regulation mechanism based on reaction kinetics is introduced. In the later stage of the reaction, pulsed high-frequency oscillation is used to effectively disrupt the diffusion boundary layer and promote the continuous collision and bonding of reactants. This not only improves the reaction efficiency but also avoids the damage of the already bonded complex to continuous high-frequency oscillation, achieving the best balance between mass transfer enhancement and structural protection.

[0031] 3. Improved detection sensitivity and consistency: The online adjustment function can automatically match the optimal oscillation strategy for the activity differences between different batches of reagent kits, eliminating the impact of reagent kit differences on the detection results. It is particularly suitable for accurate detection of low-concentration samples and high-throughput screening.

[0032] 4. Reduced detection time: Due to the reduction of ineffective incubation time caused by diffusion limitations and the acceleration of the reaction rate through dynamic oscillation, the overall detection time is shortened by 20%-30% compared to the traditional constant-speed oscillation method, thereby increasing the detection throughput.

[0033] 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 according to the contents of the specification, the preferred embodiments of the present invention are described in detail below with reference to the accompanying drawings. Specific embodiments of the present invention are given in detail below with reference to the accompanying drawings. Attached Figure Description

[0034] The accompanying drawings, which are included to provide a further understanding of the invention and form part of this application, illustrate exemplary embodiments of the invention and, together with their description, serve to explain the invention and do not constitute an undue limitation thereof. In the drawings:

[0035] Figure 1 This is a schematic diagram of the structure of a constant temperature shaking incubator for an immunoassay kit according to an embodiment of the present invention;

[0036] Figure 2 This is a front view of the internal structure of a constant temperature shaking incubator for an immunoassay kit according to an embodiment of the present invention;

[0037] Figure 3 This is a system architecture diagram of a constant temperature shaking incubator for an immunoassay kit provided in one embodiment of the present invention;

[0038] Figure 4This is a flowchart illustrating a method for adjusting the oscillation frequency of a constant temperature oscillation incubator for an immunoassay kit, as provided in an embodiment of the present invention.

[0039] The attached diagram lists the components represented by each number as follows:

[0040] 1. Enclosure; 2. Temperature control module; 201. Semiconductor cooling chip; 202. Heat sink; 203. Temperature controller; 3. Vibration platform; 4. Drive mechanism; 401. Eccentric wheel motor; 402. Connecting rod; 5. Control system; 6. Online temperature detection unit; 7. Optical detection unit; 701. Light source; 702. Photoelectric sensor. Detailed Implementation

[0041] The following is in conjunction with the appendix Figures 1-4 The principles and features of the present invention are described below. The examples given are for illustrative purposes only and are not intended to limit the scope of the invention. The invention is described more specifically in the following paragraphs by way of example with reference to the accompanying drawings. The advantages and features of the invention will become clearer from the following description. It should be noted that the drawings are in a very simplified form and use non-precise proportions, and are only used to facilitate and clarify the illustration of the embodiments of the invention.

[0042] It should be noted that when a component is described as "fixed to" another component, it can be directly on the other component or may have a component in between. When a component is considered "connected to" another component, it can be directly connected to the other component or may have a component in between. When a component is considered "set on" another component, it can be directly set on the other component or may have a component in between. The terms "vertical," "horizontal," "left," "right," and similar expressions used in this document are for illustrative purposes only.

[0043] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0044] Example 1, such as Figure 1 and Figure 2 As shown, this embodiment provides a constant temperature shaking incubator for an immunoassay kit, which includes a box body 1, a constant temperature module 2, a shaking platform 3, a drive mechanism 4, and a control system 5. The incubator also includes an online temperature detection unit 6 and an optical detection unit 7.

[0045] The enclosure 1 is made of double-layer stainless steel plates with insulation material in between, which has good heat insulation performance. The constant temperature module 2 is a semiconductor cooling chip assembly, which is installed on the inner wall of the enclosure 1 and forms a uniform temperature field with the inside of the enclosure 1 through the circulating air duct.

[0046] The oscillation platform 3 is made of aluminum alloy and has a slot on its surface for fixing the reagent kit. The drive mechanism 4 includes an eccentric wheel motor 401 and a connecting rod 402. One end of the connecting rod 402 is connected to the eccentric wheel motor 401 and the other end is connected to the oscillation platform 3. By adjusting the speed and eccentricity of the eccentric wheel motor 401, the oscillation frequency can be continuously adjusted in the range of 50-500 rpm and the oscillation amplitude can be continuously adjusted in the range of 1-10 mm.

[0047] The online temperature detection unit 6 is located inside the housing 1. Specifically, in this embodiment, the online temperature detection unit 6 is installed above the vibration platform 3 and uses an infrared temperature sensor to detect the temperature of the reagent kit surface in real time in a non-contact manner, so as to avoid contaminating the reagent kit.

[0048] The optical detection unit 7 is positioned above the oscillation platform 3, specifically, as follows: Figure 3 As shown, the optical detection unit 7 includes a light source 701 and a photoelectric sensor 702. The light source 701 and the photoelectric sensor 702 are arranged opposite each other above the oscillation platform 3, so that the detection light path passes vertically through the transparent reaction hole of the reagent kit, which is used to monitor the changes in turbidity or transmittance of the reaction liquid in real time and transmit the signal to the control system 5.

[0049] The control system 5 has built-in target temperature-time curves and target turbidity-time curves. These curves are used to receive feedback signals from the online temperature detection unit 6 and the optical detection unit 7. Based on PID control algorithms or fuzzy control algorithms, the system adjusts the heating power of the constant temperature module 2, the oscillation frequency of the drive mechanism 4, and the oscillation amplitude, respectively, so that the actual temperature and mixing state of the reaction system change along the target temperature-time curves and the target turbidity-time curves, respectively. Figure 3 As shown, the control system 5 also includes multiple auxiliary sensors, which are set in different positions inside the housing 1 to assist in monitoring the environment and provide multi-dimensional environmental parameters for the control system 5 to optimize the control strategy.

[0050] Example 2: This example provides a method for adjusting the oscillation frequency of an immunoassay kit based on the above system, such as... Figure 4 As shown, it includes the following steps:

[0051] S1: Loading stage, the immunoassay kit to be incubated is placed on the shaking platform 3 and fixed by the slot. In this embodiment, the kit to be incubated is an ELISA 96-well plate, the detection item is the novel coronavirus N protein antibody, and the total volume of the incubation system is 100μL / well.

[0052] S2: During the preheating and premixing stage, the control system 5 starts the constant temperature module 2 and the drive mechanism 4 to raise the temperature inside the chamber 1 to the preset initial incubation temperature of 37°C. At the same time, the reagent kit is premixed with the preset initial oscillation frequency and amplitude. In this embodiment, the initial oscillation frequency is set to 250 rpm, the oscillation amplitude is 3 mm, and the premixing time is 2 minutes to ensure that the reaction liquid and the solid surface are in full contact.

[0053] S3: Online monitoring and main reaction stage. The online temperature detection unit 6 and the optical detection unit 7 monitor the temperature of the reagent kit and the turbidity of the reaction solution in real time. The control system 5 dynamically adjusts the oscillation frequency and oscillation amplitude according to the deviation between the real-time turbidity and the preset target turbidity-time curve. In this embodiment, the preset target turbidity-time curve is a typical ELISA binding kinetic curve. When the actual turbidity change rate is lower than the target value, the control system 5 increases the oscillation frequency by 20 rpm and the amplitude by 1 mm; otherwise, it decreases the parameters.

[0054] S4: Frequency optimization and reaction acceleration stage. When the rate of change of turbidity of the reaction liquid is lower than the preset first threshold, the control system 5 determines that the reaction has entered the plateau period and starts the frequency adjustment strategy. In this embodiment, the first threshold is set to 25% of the maximum rate of change of turbidity of the reaction liquid (that is, it is triggered when the instantaneous rate of change is lower than 25% of the maximum rate of change). The drive mechanism 4 adopts an intermittent pulse oscillation mode: a 30-second high-frequency pulse oscillation of 400 rpm is performed every 2 minutes, and the low-frequency oscillation of 100 rpm is maintained for the rest of the time. At the same time, the control system 5 maintains the heating power of the constant temperature module 2 to ensure that the temperature is stable at 37±0.5℃.

[0055] During this stage, the control system 5 also adjusts the oscillation frequency according to the real-time change rate of the turbidity of the reaction liquid: the preset lower limit of the turbidity change rate is 0.5% / min, and the upper limit is 2.5% / min. When the real-time change rate is lower than 0.5% / min, the control system 5 increases the pulse frequency (e.g., adjusts it to pulse once every 1.5 minutes); when the change rate is higher than 2.5% / min, the pulse frequency is reduced or the pulse oscillation is paused, and the basic oscillation frequency is appropriately reduced. Through this dynamic adjustment, the diffusion boundary layer is effectively broken. This acceleration stage lasts for about 10 minutes, and the turbidity of the reaction liquid increases from 50% of the maximum value to 85%.

[0056] S5: In the final reaction stage, when the rate of change of turbidity of the reaction liquid drops to the preset second threshold, the control system 5 reduces the oscillation frequency to the initial value and maintains a constant temperature until the turbidity of the reaction liquid reaches the target final value. In this embodiment, the second threshold is set to 8% of the maximum rate of change of turbidity of the reaction liquid (i.e., it is triggered when the instantaneous rate of change is less than 8%). The target final value is the average value of the stable fluctuation of turbidity of the reaction liquid for 3 minutes after it reaches the plateau period. The control system 5 gradually restores the oscillation frequency to 200 rpm and continues to incubate for 5 minutes until the optical detection unit 7 displays that the turbidity value is stable within the range of 0.85±0.02 OD.

[0057] S6: End and read, stop oscillation, maintain constant temperature, and read the final optical density value of the kit by an external microplate reader;

[0058] The ELISA test results obtained in this embodiment showed that the average OD value of the positive control well was 1.25, the coefficient of variation (CV%) was 3.2%, the average OD value of the negative control well was 0.08, and the signal-to-noise ratio reached 15.6, which was significantly better than the traditional constant-speed shaking incubation (CV% 8.5%, signal-to-noise ratio 11.2). The total reaction time was shortened from 60 minutes in the traditional method to 42 minutes.

[0059] In summary, the isothermal shaking incubator and its shaking frequency adjustment method for immunoassay kits provided by this invention provide real-time feedback on the turbidity changes of the reaction liquid through an optical detection unit, dynamically adjust the shaking frequency and amplitude in combination with a control system, and introduce pulse shaking to enhance the mass transfer mechanism in the later stage of the reaction. This effectively solves the problems of low reaction efficiency and large batch-to-batch differences in traditional processes, and significantly improves the sensitivity and consistency of immunoassay results.

[0060] It should be noted that, in this document, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Content not described in detail in this specification is prior art known to those skilled in the art.

[0061] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Those skilled in the art can readily implement the present invention based on the accompanying drawings and the above description. However, any modifications, alterations, or variations made by those skilled in the art without departing from the scope of the present invention, utilizing the disclosed technical content, are equivalent embodiments of the present invention. Furthermore, any modifications, alterations, or variations made to the above embodiments based on the essential technology of the present invention are still within the protection scope of the present invention.

Claims

1. A constant temperature shaking incubator for an immunoassay kit and a method for adjusting the shaking frequency thereof, comprising a chamber (1), a constant temperature module (2), a shaking platform (3), a driving mechanism (4), and a control system (5); characterized in that, It also includes an online temperature detection unit (6) and an optical detection unit (7); The online temperature detection unit (6) is located inside the box (1) and is used to collect the current temperature signal of the reagent kit in real time and transmit it to the control system (5). The optical detection unit (7) is positioned above the oscillation platform (3) and is used to monitor the changes in turbidity or transmittance of the reaction liquid in the reagent kit in real time and transmit the signal to the control system (5). The control system (5) has a built-in target temperature-time curve and target turbidity-time curve, which are used to receive feedback signals from the online temperature detection unit (6) and the optical detection unit (7), and adjust the heating power of the constant temperature module (2), the oscillation frequency and oscillation amplitude of the drive mechanism (4) based on the PID control algorithm or the fuzzy control algorithm, so that the actual temperature and mixing state of the reaction system change along the target temperature-time curve and the target turbidity-time curve, respectively.

2. The isothermal shaking incubator for an immunoassay kit according to claim 1, characterized in that, The online temperature detection unit (6) uses an infrared temperature sensor to detect the temperature of the reagent kit surface in real time in a non-contact manner.

3. The isothermal shaking incubator for an immunoassay kit according to claim 1, characterized in that, The optical detection unit (7) includes a light source (701) and a photoelectric sensor (702). The light source (701) and the photoelectric sensor (702) are arranged opposite each other above the oscillation platform (3) so that the detection light path passes vertically through the transparent reaction hole of the reagent kit.

4. The isothermal shaking incubator for an immunoassay kit according to claim 1, characterized in that, The drive mechanism (4) includes an eccentric wheel motor (401) and a connecting rod (402). One end of the connecting rod (402) is connected to the eccentric wheel motor (401), and the other end is connected to the oscillation platform (3). By adjusting the speed and eccentricity of the eccentric wheel motor (401), the oscillation frequency can be continuously adjusted within the range of 50-500 rpm, and the oscillation amplitude can be continuously adjusted within the range of 1-10 mm.

5. The isothermal shaking incubator for an immunoassay kit according to claim 1, characterized in that, The constant temperature module (2) includes a semiconductor cooling chip (201), a heat sink (202) and a temperature controller (203). The semiconductor cooling chip (201) is attached to the inner wall of the box (1) and switches between heating and cooling functions by changing the direction of the current, so as to control the temperature inside the box (1) between 25℃ and 45℃.

6. A method for adjusting the oscillation frequency of an immunoassay kit based on the system of any one of claims 1 to 5, characterized in that, Includes the following steps: S1: Loading stage, place the immunoassay kit to be incubated on the shaking platform (3) and fix it; S2: During the preheating and premixing stage, the control system (5) starts the constant temperature module (2) and the drive mechanism (4) to raise the temperature inside the box (1) to the preset initial incubation temperature, and at the same time premixes the reagent kit with the preset initial oscillation frequency and amplitude. The initial oscillation frequency is 200-300 rpm. S3: Online monitoring and main reaction stage, the online temperature detection unit (6) and optical detection unit (7) monitor the temperature of the reagent kit and the turbidity of the reaction liquid in real time, and the control system (5) dynamically adjusts the oscillation frequency and oscillation amplitude according to the deviation between the real-time turbidity and the preset target turbidity-time curve; S4: Frequency optimization and reaction acceleration stage. When the turbidity change rate of the reaction liquid is lower than the preset first threshold, the control system (5) determines that the reaction has entered the plateau period and starts the frequency adjustment strategy to increase the oscillation frequency in the intermittent pulse oscillation mode to promote antigen-antibody binding, while maintaining the heating power of the constant temperature module (2) to prevent temperature fluctuations. S5: In the final reaction stage, when the rate of change of turbidity of the reaction liquid drops to the preset second threshold, the control system (5) reduces the oscillation frequency to the initial value and maintains constant temperature until the turbidity of the reaction liquid reaches the target final value. S6: End reading, stop oscillation, maintain constant temperature, and have the final signal value of the reagent kit read by an external detection device.

7. The method for adjusting the oscillation frequency of an immunoassay kit according to claim 6, characterized in that, In step S4, the oscillation frequency of the driving mechanism (4) is adjusted according to the real-time change rate of turbidity of the reaction liquid: when the turbidity change rate is less than the preset lower limit, the oscillation frequency is increased or intermittent high-frequency pulse oscillation is used to break the diffusion boundary layer and accelerate the collision of reactants; when the turbidity change rate is greater than the preset upper limit, the oscillation frequency is reduced to avoid shearing damage to the formed antigen-antibody complex.

8. The method for adjusting the oscillation frequency of an immunoassay kit according to claim 6, characterized in that, In steps S3 to S5, the incubation temperature is controlled between 35℃ and 40℃, the oscillation frequency is controlled between 50 and 500 rpm, and the overall incubation time is 15 to 60 minutes.

9. The method for adjusting the oscillation frequency of an immunoassay kit according to claim 6, characterized in that, The preset first threshold is 20%-30% of the maximum change rate of turbidity in the reaction solution, the preset second threshold is 5%-10% of the maximum change rate of turbidity in the reaction solution, and the target final value is the average value of the stable fluctuations after the turbidity of the reaction solution reaches a plateau period.

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