Microorganism detection device, system and method

Abstract

The invention provides a microbiological detection device, system and method, and the method comprises the following steps: controlling a to-be-detected liquid to be input into an incubation cavity through a sample inlet for incubation, and collecting an impedance signal of the to-be-detected liquid in the incubation cavity through an electrode assembly; after determining that a microorganism proliferation trend exists in the liquid to be detected according to the impedance signal, controlling an indicator to be input into the incubation cavity through a reagent inlet, and acquiring a color verification image of the liquid to be detected in the incubation cavity through an image acquisition device; and determining a microbial detection result according to the real-time modal signal, wherein the real-time modal signal comprises an impedance signal and a color verification image. According to the invention, synchronous acquisition of multi-mode optical signals can be realized, the detection sensitivity and the anti-interference capability are improved, the detection efficiency is improved, and the detection error is reduced.

Description

Technical Field

[0001] The present invention belongs to the field of biomedical technology, and in particular relates to a microorganism detection device, system and method. Background Art

[0002] Microbial testing is crucial in many fields, including food, pharmaceuticals, and healthcare. However, existing microbial testing methods can be susceptible to interference from ion fluctuations, cell residues, and other factors, leading to errors. Furthermore, the testing process can rely on manual experience and be subjective, which is also prone to errors. Furthermore, existing microbial testing devices generally lack flexibility and containment, making it difficult to implement mid-process reagent addition and simultaneous multimodal signal acquisition in a sterile environment. This limits their application in high-hygiene scenarios such as pharmaceutical production and food processing. Summary of the Invention

[0003] The present invention addresses the technical problems in the prior art that microbial detection devices are difficult to achieve mid-process reagent addition and synchronous acquisition of multimodal signals in a sterile environment, and that microbial detection methods are susceptible to interference and errors. A microbial detection device, system and method are provided.

[0004] In view of the above technical problems, an embodiment of the present invention provides a microorganism detection device, comprising: The detection element is provided with a sample inlet, a reagent inlet, and an incubation chamber communicating with the sample inlet and the reagent inlet; an electrode assembly, at least a portion of which is located in the incubation chamber; The electrode assembly is used to collect the impedance signal of the liquid to be tested in the incubation chamber after the liquid to be tested is input into the incubation chamber through the sampling port for incubation; the reagent inlet is used to allow the indicator to enter the incubation chamber after determining the presence of a microbial proliferation trend in the liquid to be tested based on the impedance signal.

[0005] An embodiment of the present invention also provides a microorganism detection system, comprising an image acquisition device, a controller, and the above-mentioned microorganism detection device; the controller is connected to the electrode assembly and the image acquisition device, and the image acquisition device is used to capture a color verification image of the liquid to be tested in the incubation chamber after the indicator is input into the incubation chamber through the reagent inlet.

[0006] An embodiment of the present invention further provides a microbial detection method, which is applied to the above-mentioned microbial detection system, and the method includes: Controlling the test liquid to be input into the incubation chamber through the sampling port for incubation, and collecting the impedance signal of the test liquid in the incubation chamber through the electrode assembly; After determining that there is a microbial proliferation trend in the test liquid according to the impedance signal, controlling the indicator to be input into the incubation chamber through the reagent inlet, and capturing a color verification image of the test liquid in the incubation chamber through an image acquisition device; A microorganism detection result is determined based on a real-time modal signal, wherein the real-time modal signal includes the impedance signal and the color calibration image.

[0007] After a test liquid is introduced into an incubation chamber through the inlet of the detection element for incubation, the electrode assembly of the microbial detection device of the present invention can collect an impedance signal of the test liquid in the incubation chamber. Furthermore, after determining the presence of a microbial proliferation trend in the test liquid based on the impedance signal, an indicator is controlled to enter the incubation chamber through the reagent inlet of the detection element. Subsequently, the microbial detection system's microscopic imaging module can collect a microscopic verification image of the test liquid in the incubation chamber after the color verification image indicates a color change corresponding to preset color change information. Finally, the microbial detection result is determined based on the real-time modal signal (which includes the impedance signal and the color verification image). In this microbial detection process, the impedance signal collected by the electrode assembly is first used to dynamically track changes in the metabolic activity of microorganisms that may be present in the test liquid. After determining the presence of a microbial proliferation trend in the test liquid based on the impedance signal, an indicator is introduced into the incubation chamber. The color reaction of the indicator, as displayed in the color verification image captured by the image acquisition device, further verifies the extent of microbial proliferation in the test liquid.

[0008] In the present invention, the microbial detection results determined based on the combined dual modal signals of the impedance signal and the color calibration image are highly sensitive, interference-resistant, rapid, and accurate. Specifically, the impedance signal can accurately track minute changes in early microbial metabolic activity in real time, sensitively detecting subtle fluctuations in conductivity in the test fluid. Even at extremely low microbial concentrations, this method can promptly respond to the initial stages of microbial metabolic activity and confirm the presence of microbial proliferation trends in the test fluid. Subsequently, an indicator is injected into the incubation chamber. The indicator's unique redox colorimetric properties allow for a preliminary determination of the microbial proliferation trend and then accurately reflect the extent of microbial proliferation. The color change is clear and intuitive, effectively avoiding errors caused by subjective human interpretation. In this way, the impedance signal reflects the dynamic metabolic activity, focusing on the changes in physiological activities during the growth of microorganisms, while the color reaction of the indicator presents the degree of biochemical reaction, focusing on the chemical color development results after the microbial metabolism reaches a certain level. Through the coordinated cooperation and mutual verification of the two modal signals of impedance signal and indicator color reaction, the detection sensitivity is greatly improved on the basis of ensuring the accuracy of microbial detection results. At the same time, it can also eliminate misjudgments caused by factors such as ion interference, thereby effectively screening out real microbial signals and significantly enhancing anti-interference ability.

[0009] At the same time, since the present invention can use the impedance signal to respond to the early warning advantage when the microbial metabolic activity just begins to become active, combined with the color reaction of the indicator, it can quickly lock the confirmation time of microbial contamination, significantly shorten the detection cycle, and greatly improve the detection efficiency. It can meet the needs of scenarios with extremely high timeliness requirements such as the rapid release of cell therapy products and online quality inspection in the food industry, effectively shortening production waiting time and improving production efficiency.

[0010] Moreover, the incubation and detection processes of the present invention are both carried out in the incubation chamber of the same detection part. The incubation chamber is a relatively independent and stable detection microenvironment, which supports the in-situ addition of indicators through the reagent inlet during the culture process without opening the detection part or transferring the test liquid, thereby avoiding the risk of contamination that may be introduced during the sampling process and requiring no manual operation throughout the process. It is also flexible and closed, and can realize the mid-way addition of reagents and the synchronous acquisition of multimodal signals in a sterile environment. In this way, the application limitations of the present invention in high-sanitation standard scenarios such as pharmaceutical production and food processing are reduced, the detection error is also reduced, and the standardization and normalization of the detection process are improved. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The present invention will be further described below with reference to the accompanying drawings and examples.

[0012] Figure 1 It is a schematic diagram of the explosion structure of a microorganism detection device provided by one embodiment of the present invention.

[0013] Figure 2 It is a perspective structural diagram of a microorganism detection device provided by one embodiment of the present invention.

[0014] Figure 3 It is a schematic diagram of the assembly structure of a microorganism detection device provided by one embodiment of the present invention.

[0015] Figure 4 It is a structural schematic diagram of a microorganism detection device provided by one embodiment of the present invention.

[0016] Figure 5 It is a schematic diagram of the three-dimensional structure of the box body of the microorganism detection device provided by one embodiment of the present invention.

[0017] Figure 6 It is a schematic diagram of the explosion structure of a microorganism detection device provided by another embodiment of the present invention.

[0018] Figure 7 It is a perspective structural diagram of a microorganism detection device provided by another embodiment of the present invention.

[0019] Figure 8It is a schematic diagram of the assembly structure of a microorganism detection device provided by another embodiment of the present invention.

[0020] Figure 9 It is a structural schematic diagram of a microorganism detection device provided by another embodiment of the present invention.

[0021] Figure 10 It is a schematic diagram of the three-dimensional structure of the cover of the microorganism detection device provided by another embodiment of the present invention.

[0022] Figure 11 1 is a schematic top view of the cover of a microorganism detection device provided by another embodiment of the present invention.

[0023] Figure 12 It is a schematic diagram of the three-dimensional structure of the box body of the microorganism detection device provided by another embodiment of the present invention.

[0024] Figure 13 Schematic diagram of injecting a test liquid into an incubation chamber of a microorganism detection device according to an embodiment of the present invention.

[0025] Figure 14 1 is a schematic structural diagram of a microorganism detection device provided by another embodiment of the present invention when placed vertically.

[0026] Figure 15 It is a structural diagram of a microorganism detection system provided by one embodiment of the present invention.

[0027] Figure 16 This is a flow chart of a microbial detection method provided by one embodiment of the present invention.

[0028] Figure 17 It is a schematic diagram of the electrical impedance amplitude corresponding to the impedance signal collected by the electrode assembly when a negative sample is detected using the microorganism detection method provided by an embodiment of the present invention.

[0029] Figure 18 It is a microscopic verification image collected by a microscopic imaging module when a negative sample is detected using the microbial detection method provided by an embodiment of the present invention.

[0030] Figure 19 This is a schematic diagram of the electrical impedance amplitude corresponding to the impedance signal collected when a positive sample is detected using the microorganism detection method provided by an embodiment of the present invention.

[0031] Figure 20 It is a microscopic verification image collected by a microscopic imaging module when a positive sample is detected using the microbial detection method provided by an embodiment of the present invention.

[0032] Figure 21The figure is a schematic diagram of the electrical impedance amplitude corresponding to the impedance signal collected by the electrode assembly when a Staphylococcus aureus sample is detected using the microorganism detection method provided by an embodiment of the present invention.

[0033] Figure 22 The figure is a schematic diagram of the percentage change of the electrical impedance amplitude corresponding to the impedance signal collected by the electrode assembly when the Staphylococcus aureus sample is detected using the microorganism detection method provided by one embodiment of the present invention.

[0034] Figure 23 The figure is a schematic diagram of the color change of the test liquid after adding the indicator when the Staphylococcus aureus sample is detected using the microorganism detection method provided by one embodiment of the present invention.

[0035] Figure 24 It is a microscopic verification image collected by a microscopic imaging module when a Staphylococcus aureus sample is detected using the microbial detection method provided by an embodiment of the present invention.

[0036] The reference numerals in the specification are as follows: 1. Detection part; 101. Sample injection port; 102. Reagent inlet; 103. Incubation chamber; 104. Detection body; 1041. Cover body; 1042. Box body; 105. First liquid inlet pipe; 106. Second liquid inlet pipe; 107. First one-way valve; 108. Second one-way valve; 109. Sealing assembly; 1091. Flexible rubber plug; 1092. Sealing cover; 110. Reagent vesicle; 111. Supporting part; 112. Liquid inlet hole; 113. Capsule rupturing part; 114. Protective cover; 115. Sample bottle mouth; 116. Mounting hole; 2. Electrode assembly; 21. First electrode; 22. Second electrode; 3. Image acquisition device; 31. Camera module; 32. Microscopic imaging module; 4. Sample injection container; 5. Reagent container; 6. Phase-locked amplifier. DETAILED DESCRIPTION

[0037] In order to make the technical problems, technical solutions and beneficial effects solved by the present invention more clearly understood, the present invention is further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0038] like Figures 1 to 15 As shown, an embodiment of the present invention provides a microorganism detection device, comprising: The detection element 1 is provided with a sample inlet 101, a reagent inlet 102, and an incubation chamber 103 communicating with the sample inlet 101 and the reagent inlet 102; Electrode assembly 2, at least a portion of the electrode assembly 2 is located in the incubation chamber 103; in some embodiments, the electrode assembly 2 includes a first electrode 21 and a second electrode 22; wherein the first electrode 21 and the second electrode 22 can both be metal electrodes (such as inert metal electrodes). Furthermore, one end of the first electrode 21 and the second electrode 22 are both extended into the interior of the chamber to ensure that the first electrode 21 and the second electrode 22 can maintain good electrical contact with the test liquid in the incubation chamber 103, so as to accurately detect the impedance changes caused by the growth and metabolism of microorganisms and realize real-time detection of the growth status of microorganisms; the other ends of the first electrode 21 and the second electrode 22 are arranged outside the incubation chamber 103 for connection to an external detection device, such as a lock-in amplifier 6, to monitor the impedance signal changes in real time. It can be understood that a mounting hole 116 is provided on the detection member 1, and one end of the first electrode 21 and the second electrode 22 is located in the incubation chamber 103, and the other end extends to the outside of the incubation chamber 103 through the mounting hole 116. In the present invention, the electrode assembly 2 is connected to a high-precision lock-in amplifier 6 for dynamic, real-time monitoring of the impedance signal of the test fluid. This amplifier possesses exceptional signal processing capabilities, enabling precise amplification and effective filtering of the collected impedance signal, significantly reducing noise interference and significantly improving signal quality. The processed analog signal is then efficiently converted into a digital signal and stably transmitted to a controller for further processing.

[0039] Understandably, in Figures 1 to 3 In the embodiment shown, the first electrode 21 and the second electrode 22 are relatively arranged on both sides of the detection member 1. At this time, the first electrode 21 and the second electrode 22 are also located on opposite sides of the incubation chamber 103, thereby forming a relatively uniform electric field distribution. This uniform electric field is conducive to accurately measuring the impedance signal in the test liquid, reducing the measurement error caused by the uneven electric field, and thus providing more reliable microbial detection results. At the same time, the layout of the first electrode 21 and the second electrode 22 being located on opposite sides of the incubation chamber 103 can enable the first electrode 21 and the second electrode 22 to fully capture the impedance signal changes of the test liquid in the incubation chamber 103 from different directions. For some microbial metabolites that are unevenly distributed in the incubation chamber 103, the overall impedance changes can be more comprehensively reflected. And in Figures 6 to 8 In the illustrated embodiment, the first electrode 21 and the second electrode 22 are disposed on the same side of the detection element 1. Placing the two electrodes on the same side saves space, making the detection element 1 more compact and enabling impedance signal measurement within a limited space. This facilitates the design of a miniaturized microbial detection device. Furthermore, placing the two electrodes on the same side provides more space and flexibility for the layout of other components (such as the reagent vesicle 110, the sample injection port 101, and the reagent inlet 102) around the incubation chamber 103, facilitating the integration of multiple functions.

[0040] Among them, the electrode assembly 2 is used to collect the impedance signal of the test liquid in the incubation chamber 103 after the test liquid is input into the incubation chamber 103 for incubation through the sampling port 101, and use the impedance signal to track the slight changes in the early metabolic activity of the microorganisms in real time and accurately, and keenly detect the slight fluctuations in the conductivity of the test liquid. Even when the concentration of microorganisms is extremely low, it can respond in time in the initial stage of the microbial metabolic activity and confirm the presence of a microbial proliferation trend in the test liquid. The reagent inlet 102 is used to supply the indicator to the incubation chamber 103 after determining the presence of a microbial proliferation trend in the test liquid based on the impedance signal, and then the unique redox color development indication characteristics of the indicator can be used to accurately reflect the degree of microbial proliferation after preliminarily determining the microbial proliferation trend of the test liquid in the incubation chamber 103. The color change is clear and intuitive, effectively avoiding the errors caused by human subjective interpretation. That is, when microbial metabolic activity triggers a redox reaction in an indicator (such as resazurin), the color of the test liquid changes accordingly. The degree and speed of the color change are positively correlated with the degree of microbial proliferation, providing an intuitive and accurate visual basis for determining the degree of microbial proliferation. In this way, the microbial detection results determined by the two modal signals of impedance signal and color calibration image are highly sensitive, interference-resistant, fast and accurate. The impedance signal reflects dynamic metabolic activity, focusing on changes in physiological activity during microbial growth, while the color reaction of the indicator reflects the degree of biochemical reaction, focusing on the chemical color development results after microbial metabolism reaches a certain level. Through the coordinated cooperation and mutual verification of the two modal signals of impedance signal and indicator color reaction, the detection sensitivity is greatly improved while ensuring the accuracy of microbial detection results. It can also eliminate misjudgments caused by factors such as ion interference, effectively screening out true microbial signals, and significantly enhancing the anti-interference ability.

[0041] It is understandable that the test liquid can be a sample that needs to be tested for the presence of microorganisms. Microorganisms may or may not be present in the test liquid. Indicators include but are not limited to resazurin indicators. The detection element 1 is provided with an injection port 101, a reagent inlet 102, and an incubation chamber 103. The volume of the incubation chamber 103 can be designed according to requirements. The positions of the injection port 101 and the reagent inlet 102 can also be set according to requirements. For example, Figures 1 to 5 In the embodiment shown, the sample inlet 101 and the reagent inlet 102 are arranged on opposite sides of the detection element 1. Figures 6 to 8In the embodiment shown, the sample inlet 101 and the reagent inlet 102 are both provided at the top of the detection member 1. In the present invention, the sample inlet 101 and the reagent inlet 102 are independently provided so as to control the amount of the test liquid and the indicator added respectively, thereby accurately adjusting the reagent dosage, and ensuring that the volume and concentration of the reagent added each time meet the experimental requirements. For example, when performing microbial detection with different concentration gradients, the corresponding amount of the test liquid and the indicator can be accurately added. In addition, the design of the above-mentioned sample inlet 101 and the reagent inlet 102 has higher flexibility in the order and time of adding reagents, and can decide when to add the test liquid and the indicator respectively according to the specific steps and requirements of the experiment, which is conducive to accurate operation in complex experimental processes.

[0042] In the present invention, the incubation chamber 103 of the detection part 1 preferably uses materials with good biocompatibility and good optical transmittance, such as polystyrene or polycarbonate, in terms of material selection. Its size specifications and the layout and selection of electrodes are all set according to the required metal, aiming to ensure that it does not interfere with the normal growth of microorganisms while being able to efficiently and accurately collect impedance signals, color verification images and microscopic verification images.

[0043] The incubation and detection processes of the present invention are both carried out in the incubation chamber 103 of the same detection part 1, which adopts a unique integrated design, integrating a light-transmitting incubation chamber 103 structure for optical detection, an electrode assembly 2 for detecting impedance signals, and structural components for loading the test liquid and adding indicators. The incubation chamber 103 in the above structure is a relatively independent and stable detection microenvironment, which supports the in-situ addition of indicators through the reagent inlet 102 during the culture process, without opening the detection part 1 or transferring the test liquid. It is also fully adapted to the sterile environment standard and can be seamlessly embedded in the automated production process to achieve full-cycle closed-loop monitoring of microbial culture from loading the test liquid to result analysis, avoiding the risk of contamination that may be introduced in the sampling process and requiring no manual operation throughout the process, reducing the impact of manual operation on the test results, and improving the standardization and normalization of the detection process. At the same time, the above-mentioned integrated design significantly reduces the volume of the microbial detection device, greatly improves the integration and convenience of the detection, makes it easier to deploy and use in different application scenarios, and provides efficient hardware support for microbial detection. The present invention is both flexible and closed, and can realize the mid-process addition of reagents and the synchronous acquisition of multimodal signals in a sterile environment. In this way, the application limitations of the present invention in high-sanitation standard scenarios such as pharmaceutical production and food processing are reduced, and the detection error is also reduced, and the standardization and normalization of the detection process are improved. Moreover, because the present invention can respond to the early warning advantage of the impedance signal when the microbial metabolic activity just begins to become active, combined with the color reaction of the indicator, the confirmation time of microbial contamination can be quickly locked, the detection cycle can be significantly shortened, and the detection efficiency is greatly improved. It can meet the needs of scenarios with extremely high timeliness requirements such as the rapid release of cell therapy products and online quality inspection in the food industry, effectively shortening production waiting time and improving production efficiency.

[0044] In some embodiments, the detection element 1 includes a detection body 104, a first liquid inlet tube 105, and a second liquid inlet tube 106; the sample inlet 101, the reagent inlet 102, and the incubation chamber 103 are all disposed on the detection body 104. One end of the first liquid inlet tube 105 is connected to the sample inlet 101, and the other end is connected to the sample inlet container 4 for containing the test liquid; one end of the second liquid inlet tube 106 is connected to the reagent inlet 102, and the other end is connected to the reagent container 5 for containing the indicator. In the present invention, the detection body 104 is made of a transparent material such as polystyrene or polycarbonate to ensure biocompatibility and optical transparency. Alternatively, the detection body 104 may be provided with a transparent observation window, which also facilitates the subsequent use of the image acquisition device 3 to capture color verification images and microscopic verification images through the outer wall of the incubation chamber 103 outside the detection body 104. In this embodiment, the sample inlet 101 and the reagent inlet 102 are respectively arranged on opposite sides of the incubation chamber 103. The sample inlet container 4 and the reagent container 5 can be storage containers that use a power device such as a pump to drive the liquid stored therein to flow toward the incubation chamber 103, or they can be storage containers that are driven by a power device such as a pump to drive the liquid stored therein to flow toward the incubation chamber 103. Figure 13 Or the injection container (such as a syringe) shown in FIG15 , so as to accurately push the liquid stored inside toward the incubation chamber 103 .

[0045] Further, if Figure 2 and 3 As shown, the first liquid inlet pipe 105 is provided with a first one-way valve 107 to control the flow of the test liquid in the sample injection container 4 toward the incubation chamber 103; the second liquid inlet pipe 106 is provided with a second one-way valve 108 to control the flow of the indicator in the reagent container 5 toward the incubation chamber 103. That is, the above-mentioned first one-way valve 107 and second one-way valve 108 can respectively control when the test liquid and indicator are input into the incubation chamber 103, and control the volume of liquid input into the incubation chamber 103. Among them, the first one-way valve 107 and the second one-way valve 108 can respectively control the amount of the test liquid and the indicator added, thereby accurately adjusting the amount of reagent used, and can ensure that the volume and concentration of the reagent added each time meet the experimental requirements. For example, when conducting microbial detection with different concentration gradients, the corresponding amount of test liquid and indicator can be accurately added.

[0046] In some embodiments, as Figures 6 to 9 As shown, the detection part 1 includes a detection body 104, a sealing component 109 and a reagent vesicle 110; the injection port 101, the reagent inlet 102 and the incubation chamber 103 are all arranged on the detection body 104, and the sealing component 109 is installed on the injection port 101; the reagent vesicle 110 is installed at the reagent inlet 102 and is used to contain the indicator. In the present invention, the detection body 104 is made of a transparent material such as polystyrene or polycarbonate to ensure biocompatibility and optical transmittance, and it is also convenient to use the image acquisition device 3 to collect color verification images and microscopic verification images through the outer wall of the incubation chamber 103 outside the detection body 104 in the subsequent process. In this embodiment, the injection port 101 and the reagent inlet 102 are both arranged at the top of the incubation chamber 103. The sealing component 109 can be used to seal the injection port 101. Further, as Figure 6 As shown, the sealing assembly 109 includes a flexible rubber plug 1091 sealedly installed in the injection port 101, and a sealing cover 1092 covering the flexible rubber plug 1091; specifically, the injection port 101 can be provided with a sampling bottle mouth 115, the sampling bottle mouth 115 is embedded with the flexible rubber plug 1091, and the injection container 4 can be a syringe containing the liquid to be tested. In this case, Figure 13As shown in the figure, the needle of the syringe pierces the flexible rubber plug 1091, and the push rod of the syringe is pushed to load the test liquid into the incubation chamber 103. The indicator (such as resazurin indicator) is pre-stored in the reagent vesicle 110. After the reagent vesicle 110 is squeezed and broken, the pre-stored indicator will enter the incubation chamber 103 through the reagent inlet 102. In this embodiment, the test liquid is added using a syringe, and the indicator is added to the actual vesicle, which has the advantages of simple operation and reduced contamination risk. Specifically, the indicator can be automatically released by pressing the reagent vesicle 110 (or the protective cover 114 mentioned later), which reduces the steps and difficulty of the operation. In some experimental scenarios where indicators need to be added quickly, this design can save time and improve experimental efficiency. In addition, the design of the reagent vesicle 110 enables the indicator to be in a closed state when not in use, reducing the possibility of the indicator being contaminated by the outside world, and also reducing the risk of volatilization or leakage of the indicator during storage and use.

[0047] Further, if Figures 6 to 11 As shown, the detection element 1 further includes a support member 111 disposed in the reagent inlet 102 and used to support the reagent capsule 110. The support member 111 is provided with a liquid inlet through-hole 112 that communicates with the incubation chamber 103. A capsule rupture member 113 is provided on the end surface of the support member 111 facing the reagent capsule 110. The capsule rupture member 113 is used to puncture the reagent capsule 110 when squeezed by the reagent capsule 110, allowing the indicator to flow into the incubation chamber 103 through the liquid inlet through-hole 112. Furthermore, the detection element 1 further includes a protective cover 114 covering the reagent capsule 110. Protective cover 114 protects the reagent capsule 110. To inject an indicator into the incubation chamber 103, protective cover 114 can be squeezed, squeezing the reagent capsule 110 within protective cover 114. The reagent capsule 110 then presses against capsule rupturing element 113, puncturing the capsule 110 and allowing the indicator pre-stored within the reagent capsule 110 to flow into the incubation chamber 103 through the reagent inlet 102. In the present invention, the microbial detection device is preferably positioned vertically with the electrode assembly 2 facing upward before performing a microbial detection method. The capsule rupturing element includes, but is not limited to, a needle, a squeezing assembly, and the like.

[0048] Further, if Figures 1 to 14 As shown, the detection body 104 includes a cover 1041 and a box body 1042 having an opening. The cover 1041 is detachably mounted on the opening, and the incubation chamber 103 is formed between the cover 1041 and the box body 1042. That is, the box body 1042 of the detection body 104 is provided with the cover 1041 for sealing the opening. The cover 1041 and the box body 1042 can be connected by an interference fit to facilitate disassembly, or can be sealed by a sealing strip, etc., as long as the opening can be blocked and the entire incubation chamber 103 can be sealed.

[0049] like Figures 1 to 15 As shown, the present invention further provides a microorganism detection system, comprising an image acquisition device 3, a controller, and the aforementioned microorganism detection device. The controller is connected to the electrode assembly 2 and the image acquisition device 3. The image acquisition device 3 is configured to capture a color verification image of the test liquid in the incubation chamber 103 after an indicator is introduced into the incubation chamber 103 through the reagent inlet 102. Specifically, the image acquisition device 3 includes a camera module 31 (e.g., a camera) configured to capture a color verification image of the test liquid in the incubation chamber 103 after the indicator is introduced into the incubation chamber 103 through the reagent inlet 102. Specifically, the camera module 31 automatically captures a color verification image of a predetermined area of ​​the incubation chamber 103 at a preset time interval (default: 2 minutes).

[0050] In the above-described embodiment of the present invention, the microbial detection system can determine microbial detection results based on two modal signals: the impedance signal and the color calibration image. It exhibits high sensitivity, interference resistance, rapidity, and accuracy. Specifically, the impedance signal can accurately track minute changes in early-stage microbial metabolic activity in real time, sensitively detecting subtle fluctuations in conductivity within the test fluid. Even at extremely low microbial concentrations, it can promptly respond to the initial stages of microbial metabolic activity and confirm the presence of microbial proliferation trends within the test fluid. Subsequently, an indicator is injected into the incubation chamber 103. The indicator's unique redox colorimetric properties allow, after initially determining the microbial proliferation trend, to accurately reflect the extent of microbial proliferation. The color change is clear and intuitive, effectively avoiding errors caused by subjective human interpretation. In this way, the impedance signal reflects the dynamic metabolic activity, focusing on the changes in physiological activities during the growth of microorganisms, while the color reaction of the indicator shows the degree of biochemical reaction, focusing on the chemical color development results after the microbial metabolism reaches a certain level. Through the coordinated cooperation and mutual verification of the two modal signals of the impedance signal and the color reaction of the indicator, the detection sensitivity is greatly improved on the basis of ensuring the accuracy of the microbial detection results. At the same time, it can also eliminate the misjudgment caused by factors such as ion interference, thereby effectively screening out the real microbial signal, and significantly enhancing the anti-interference ability. The present invention focuses on integrating impedance kinetic detection, color reaction of the indicator and microscopic imaging technology to establish a microbial detection system based on multimodal sensing fusion. The innovative construction of the cascade detection mechanism of kinetic method, endpoint method and morphological analysis method can not only keenly capture the subtle changes in the early metabolic activity of microorganisms, but also intuitively and accurately judge the proliferation endpoint with the help of the color development of the indicator, while using microscopic imaging to directly and clearly observe the morphology of microbial cells. By deeply establishing a correlation model between the three modal signals, we successfully achieved three-dimensional collaborative verification from "metabolic activity" to "color reaction" to "colony morphology", and monitored the microbial cultivation process from all directions and angles. At the same time, because the present invention can respond to the early warning advantage of the impedance signal when the microbial metabolic activity just begins to become active, combined with the use of the color reaction of the indicator, it can quickly lock the confirmation time of microbial contamination, significantly shorten the detection cycle, and greatly improve the detection efficiency. It can meet the needs of scenarios with extremely high timeliness requirements such as the rapid release of cell therapy products and online quality inspection in the food industry, effectively shortening production waiting time and improving production efficiency.

[0051] The microbial detection system of the present invention can realize cross-domain standardized application, and the technical solution adopts a modular design concept, which can flexibly adapt to the personalized needs of different application scenarios. In the field of biomedicine, it can be used for sterility verification of highly active biological samples such as cell therapy products; in the food industry, it can realize rapid detection of microorganisms in food raw materials, production processes and finished products; in environmental monitoring, it can monitor microbial contamination in environmental samples such as water bodies and soil in real time; in clinical diagnosis, it helps to quickly and accurately detect pathogenic microorganisms in clinical samples. Compared with a single detection technology, the present invention shows significant advantages in detection speed, accuracy and scene adaptability, providing a comprehensive and standardized solution for microbial quality control.

[0052] At the spatiotemporal level, the electrical impedance method, with its unique advantages, can monitor conductivity changes in real time and continuously, stably outputting continuous time series data; indicator color development accurately reflects the degree of change in redox state within a specified time; and microscopic imaging accurately captures the morphology of microbial colonies at specific time points. From a spatial perspective, the electrical impedance method and indicator color development provide comprehensive macroscopic monitoring of the entire culture system, while microscopic imaging focuses on local microscopic spaces and precisely focuses on the morphology of microbial colonies. This carefully designed spatiotemporal complementary detection mode cleverly overcomes the difficulties faced by traditional detection methods in the face of low-concentration microbial contamination, which include insufficient sensitivity and accuracy, and difficulty in real-time online monitoring of microbial growth changes.

[0053] Among them, the microorganism detection device is described in the above embodiment and will not be described in detail here. The electrode assembly 2 in the microorganism detection device can be directly or indirectly connected to the controller for communication so as to transmit the measured impedance signal to the controller. In some embodiments, the controller is also connected to the first one-way valve 107 and the second one-way valve 108 to control the switching of the first one-way valve 107 and the second one-way valve 108. Furthermore, the microorganism detection system also includes a sample addition container and / or a reagent container 5, wherein the sample addition container is used to add the test liquid into the incubation chamber 103 through the sample inlet 101, and the reagent container 5 can add an indicator into the incubation chamber 103 through the reagent inlet 102. Preferably, the sample addition container and the reagent container 5 can both be syringes or other storage containers.

[0054] Further, if Figure 15As shown, the image acquisition device 3 includes a microscopic imaging module 32. The microscopic imaging module 32 is used to capture a microscopic verification image of the test liquid in the incubation chamber 103 after the color verification image indicates that the test liquid has undergone a color change corresponding to the preset color change information. The microscopic imaging module 32 can then determine the microbial detection result based on at least two real-time modal signals, including the impedance signal, the color verification image, and the microscopic verification image. Specifically, the microscopic imaging module 32 may include, but is not limited to, an inverted microscope, a focusing device, and a camera to periodically image the test liquid in the incubation chamber 103 to produce microscopic verification images to display the morphology of the microbial colonies in the test liquid. In this embodiment, the microscopic verification images captured by the microscopic imaging module 32 can intuitively and clearly present the morphological characteristics of the colonies, including details such as the size, shape, and edge contours of the colonies. Specifically, the camera in the microscopic imaging module 32 automatically captures microscopic verification images of a preset area of ​​the incubation chamber 103 at a preset interval (default 1.5 hours, but adjustable to other intervals as needed). This periodic imaging allows for full and dynamic observation of the morphological changes of microbial colonies during the incubation process, providing detailed morphological evidence for accurate identification and in-depth analysis of the microorganisms. Furthermore, the microbial detection results are determined based on the coordinated coordination and mutual verification of at least two real-time modal signals: the impedance signal, the color verification image, and the microscopic verification image. This significantly improves detection sensitivity while ensuring the accuracy of the microbial detection results. In actual detection tests, the above-described embodiment of the present invention successfully detected Staphylococcus aureus samples (test fluid) with concentrations as low as 5 CFU, fully demonstrating its excellent detection sensitivity.

[0055] In this embodiment, the impedance signal reflects dynamic metabolic activity, focusing on changes in physiological activities during microbial growth; the color verification image presents the degree of biochemical reaction, focusing on the chemical color development results after microbial metabolism reaches a certain level; the microscopic verification image provides morphological evidence, intuitively showing the colony morphological characteristics of microorganisms. The above three constitute a three-level verification mechanism. When the impedance signal fluctuates abnormally, the color verification image can eliminate misjudgments caused by factors such as ion interference, and the microscopic verification image can further confirm whether it is real microbial proliferation, thereby reducing the misjudgment rate in complex matrix scenarios. For example, in the detection of samples containing cell fragments and high-concentration additives, real microbial signals can be effectively screened out, and the anti-interference ability is significantly enhanced. Moreover, compared with the traditional culture method that often takes a long cycle of 14 days, the present invention, with the early warning advantage of the impedance signal, can send a signal when the microbial metabolic activity just begins to become active. Combined with the use of color verification images and microscopic verification images, it can quickly lock the confirmation time of microbial contamination and significantly compress the entire detection cycle to within 24 hours, greatly improving the detection efficiency. It can meet the needs of scenarios with extremely high timeliness requirements such as the rapid release of cell therapy products and online quality inspection in the food industry, effectively shortening production waiting time and improving production efficiency.

[0056] The controller of the present invention, with a microprocessor at its core, is responsible for controlling the operating status of each module, receiving, processing, and analyzing signals. It can also fine-tune key parameters such as the measurement frequency of the electrode assembly 2, the on / off switching of the light source, precise adjustment of the optical path system, precise adjustment of the focal length of the microscopic imaging module 32, and the interval between captures of the camera and video module 31. Furthermore, the module possesses powerful data processing and analysis capabilities, receiving real-time modal signals (impedance signals, color calibration images, and microscopic calibration images) and applying advanced algorithms to process and analyze them. By constructing a scientific mathematical model, it accurately correlates signal changes with microbial growth status and metabolic changes, enabling real-time, precise monitoring and intelligent analysis of the microbial cultivation process. Furthermore, the module is equipped with a comprehensive result display and alarm system that provides real-time and intuitive display of microbial growth status and test results. When abnormal microbial growth is detected, an alarm signal is automatically and promptly issued, prompting the operator to take prompt countermeasures.

[0057] Further, if Figure 15 As shown, the microbial detection system may also include a lock-in amplifier 6 connected between the controller and the electrode assembly 2. The various modules in the controller of the microbial detection system can be implemented in whole or in part through software, hardware, or a combination thereof. The aforementioned modules can be embedded in or independent of the controller in hardware form, or stored in the controller in software form, so that the controller can call and execute the corresponding operations of each module to implement the microbial detection method described below. The controller can be a computer device or other electronic terminal device.

[0058] like Figure 16 As shown, an embodiment of the present invention further provides a microorganism detection method, which is applied to the above-mentioned microorganism detection system. The method includes the following steps S100-S300: S100 , controlling the test liquid to be input into the incubation chamber 103 through the sampling port 101 for incubation, and collecting the impedance signal of the test liquid in the incubation chamber 103 through the electrode assembly 2 .

[0059] It is understandable that, in this embodiment, step S100 may include the following steps: Preparation and loading of the test fluid: Carefully inoculate the test fluid from the sample container 4 (e.g., a syringe) into the incubation chamber 103 of the microbial detection device, minimizing the generation of large bubbles. Simultaneously, a predetermined concentration of indicator reagent is pre-stored at the reagent inlet 102 of the microbial detection device via the aforementioned reagent container 5 or reagent vesicle 110, fully preparing for the subsequent color development reaction. For example, using a Staphylococcus aureus sample, 5 CFU of the Staphylococcus aureus sample is inoculated via syringe into the main chamber of the test cartridge containing 15 mL of TSB medium to form the test fluid.

[0060] Initializing the multimodal detection module: Initialization settings are performed, specifically setting key parameters such as the opening time and detection interval for each module of the microbial detection module (e.g., the second one-way valve 108, the electrode assembly 2, the camera module 31, and the microscopic imaging module 32). For example, the sampling frequency of the electrode assembly 2 is precisely set to 6 Hz to ensure real-time and accurate capture of impedance signal changes during microbial growth. For the microscopic imaging module 32, the preset microscopic imaging interval is set to 1.5 hours based on the microbial growth rate and the changes in colony morphology to fully record the formation and development of colonies. Simultaneously, the camera module 31 is configured to capture color verification images of the test solution after the addition of the indicator at a 2-minute interval to ensure accurate capture of critical moments of color change. After initialization is complete, the microbial detection system enters a stable standby state, and the test solution begins incubation, awaiting detection instructions.

[0061] Impedance Signal Acquisition: After receiving the test command and initiating the test, both impedance signal acquisition and microscopic imaging (collection of microscopic verification images) are simultaneously initiated. Specifically, the electrode assembly 2 accurately measures (e.g., at a sampling frequency of 6 Hz) the impedance changes of the test fluid in real time and stably transmits the impedance signal to the controller. Simultaneously, the microscopic imaging module 32 generates microscopic verification images at preset intervals and accurately transmits these images to the controller to capture dynamic changes in colony morphology. It is understood that this preset interval is pre-determined based on the microbial growth rate (e.g., the preset interval is set to a number of doubling cycles, such as three doubling cycles. A doubling cycle refers to the time required for a microbial colony to double in number or biomass during growth) to ensure effective capture of colony morphological changes. For example, if the test fluid contains Staphylococcus aureus, and the test fluid is a Staphylococcus aureus sample, and the corresponding doubling period for Staphylococcus aureus is 30 minutes, the preset interval can be set to three doubling cycles, or 1.5 hours. During the above process, the microscopic imaging module 32 begins to image the microbial colony and obtain microscopic verification images at the same time as the electrode assembly 2 detects the impedance signal (starting from the initial time point), recording its initial size, shape, distribution and other key features, which can provide basic data for subsequent monitoring. In other words, as the detection progresses, the subsequent microscopic verification images can be compared with the microscopic verification images at the initial time point, which can intuitively show the increase in the number of colonies, the enlargement of individuals and the changes in morphology, and realize the dynamic visualization monitoring of the growth status of microorganisms throughout the process. Figure 17 It can be seen that when the microbial detection method of the present invention is used to detect a negative sample (a test liquid that does not contain microorganisms), the impedance amplitude corresponding to the impedance signal collected by the electrode assembly 2 does not change over time; Figure 19 It can be seen from the figure that when the positive sample (the test liquid containing microorganisms) is tested using the microorganism detection method of the present invention, the impedance amplitude corresponding to the impedance signal collected by the electrode assembly 2 gradually decreases over time. Figure 21 It can also be seen that when the microbial detection method of the present invention is used to detect Staphylococcus aureus samples, the impedance amplitude corresponding to the impedance signal collected by the electrode assembly 2 gradually decreases over time. Figure 22 It can be seen that when the Staphylococcus aureus sample is detected using the microbial detection method provided by the present invention, the electrical impedance amplitude percentage corresponding to the impedance signal collected by the electrode assembly 2 also gradually decreases over time.

[0062] S200, after determining the presence of a microbial proliferation trend in the test liquid based on the impedance signal, controlling the indicator to be fed into the incubation chamber 103 through the reagent inlet 102, and capturing a color verification image of the test liquid in the incubation chamber 103 through the image acquisition device 3; In some embodiments, in step S200, determining the presence of a microbial proliferation trend in the test liquid based on the impedance signal includes: S201, obtain the initial impedance value corresponding to the initial time point of incubation of the test liquid in the incubation chamber 103, and determine the impedance difference between the impedance signal and the initial impedance value; wherein, the initial impedance value can be the impedance amplitude, or the percentage change of the impedance amplitude, etc., and the impedance difference can be obtained by converting the impedance signal into the same type of data as the initial impedance value, and then taking the difference between the converted impedance signal and the initial impedance value.

[0063] S202: When the absolute value of the ratio of the impedance difference to the initial impedance value exceeds a preset impedance decrease threshold, it is determined that there is a microbial proliferation trend in the test liquid.

[0064] In this embodiment, when the ratio between the impedance difference and the initial impedance value (i.e., the change in the impedance signal at the current time point relative to the impedance signal at the initial time point) is detected to exceed a preset impedance drop threshold, it is determined that there is a microbial proliferation trend in the test liquid, thereby triggering the indicator color verification process, that is, the indicator is controlled to be released into the incubation chamber 103, and the camera module 31 of the image acquisition device 3 begins to take pictures and record the color changes of the test liquid at a set time interval (e.g., every 2 minutes), and stably transmits the color verification image to the controller to further verify the growth status of the microorganisms. The preset impedance drop threshold can be set according to demand, and the preset impedance drop threshold can ensure a balance between early metabolic activity capture and interference elimination. Since the test results of the test liquid corresponding to the negative sample show that the ratio between its impedance difference and the initial impedance value is usually less than or equal to 2%, the preset drop threshold can be set to be greater than 2% according to actual conditions, such as 5%. In the detection of Staphylococcus aureus samples, Figure 21 and Figure 22 The schematic diagrams of the impedance amplitude and the percentage change of the impedance amplitude corresponding to the impedance signal show that the impedance amplitude begins to decrease after about 12 hours of incubation of Staphylococcus aureus, and decreases by about 5% after about 18 hours of incubation (that is, the ratio of the impedance difference to the initial impedance value exceeds the preset impedance decrease threshold). At this time, it is determined that there is a trend of microbial proliferation in the test liquid.

[0065] Furthermore, if the absolute value of the ratio between the impedance difference and the initial impedance value does not exceed the preset impedance drop threshold, it is determined that there is no microbial proliferation trend in the test liquid, and the impedance signal is continuously detected, and it is determined whether the current color development period exceeds the preset detection time (the current color development period refers to the period between the color development start point when the indicator enters the incubation chamber 103 and the current time point. The preset detection time can be set as needed, for example, to 24 hours). If it does not exceed the preset detection time, the impedance signal is continuously detected until the absolute value of the ratio between the impedance difference and the initial impedance value exceeds the preset impedance drop threshold, and it is determined that there is a microbial proliferation trend in the test liquid. If the absolute value of the ratio between the impedance difference and the initial impedance value continues to not exceed the preset impedance drop threshold, but the current color development period exceeds the preset detection time, the impedance signal detection process is terminated, and the microbial detection result is determined to be that there are no microorganisms in the test liquid, that is, the microbial detection result is negative, that is, no microbial growth is detected in the test liquid.

[0066] S300 determines the microbial detection result based on the real-time modal signal, which includes the impedance signal and the color verification image. Specifically, the controller can pre-process the received real-time modal signal (including the impedance signal and the color verification image) and associate it with the microbial growth status. A dynamic weight allocation algorithm is then used to fuse the modal signals, comprehensively considering the data provided by different real-time modal signals to ensure that the analysis results more comprehensively and accurately reflect the actual microbial growth status. Based on the comprehensive score obtained from data processing and analysis, the microbial growth status is determined and the microbial detection result is obtained. Furthermore, the controller can display the microbial detection results. If the microbial detection result indicates the presence of microorganisms in the test fluid, an alarm can be issued to a preset terminal to alert relevant personnel for further processing. Alarms can be provided in various forms, including audible alarms, light alarms, and text message alarms, prompting operators to promptly take appropriate measures. The controller can also store data generated during the detection process in real time in a large-capacity storage module. This data comprehensively includes one or more of the impedance signal, the color verification image, the microscopic verification image, and the corresponding analysis results, ensuring data integrity and traceability. It also supports exporting data into common formats such as csv and png, which facilitates further analysis and sharing of data.

[0067] The electrode assembly 2 of the microorganism detection device of the present invention can collect the impedance signal of the liquid to be tested in the incubation chamber 103 after the liquid to be tested is input into the incubation chamber 103 through the sampling port 101 of the detection component 1 for incubation. Then, after determining that there is a trend of microbial proliferation in the liquid to be tested based on the impedance signal, the indicator is controlled to enter the incubation chamber 103 through the reagent inlet 102 of the detection component 1. Afterwards, the microscopic imaging module 32 of the microorganism detection system can collect a microscopic verification image of the liquid to be tested in the incubation chamber 103 after the color verification image indicates that the liquid to be tested has a color change corresponding to the preset color change information, and finally determine the microorganism detection result based on the real-time modal signal (the real-time modal signal includes the impedance signal and the color verification image). During the above-mentioned microbial detection process, the impedance signal collected by the electrode assembly 2 is first used to dynamically track the changes in the metabolic activity of the microorganisms that may be present in the test liquid. After determining that there is a microbial proliferation trend in the test liquid based on the impedance signal, the indicator is input into the incubation chamber 103, and then the color reaction of the indicator displayed in the color verification image collected by the image acquisition device 3 is used to further verify the degree of microbial proliferation in the test liquid.

[0068] In the present invention, the microbial detection results determined based on the combined dual modal signals of the impedance signal and the color calibration image are highly sensitive, interference-resistant, rapid, and accurate. Specifically, the impedance signal can accurately track minute changes in early microbial metabolic activity in real time, sensitively detecting subtle fluctuations in conductivity in the test fluid. Even at extremely low microbial concentrations, this method can promptly respond to the initial stages of microbial metabolic activity and confirm the presence of microbial proliferation trends in the test fluid. Only then is an indicator injected into the incubation chamber 103. The indicator's unique redox colorimetric properties allow, after initially determining the microbial proliferation trend, to accurately reflect the extent of microbial proliferation. The color change is clear and intuitive, effectively avoiding errors caused by subjective human interpretation. In this way, the impedance signal reflects the dynamic metabolic activity, focusing on the changes in physiological activities during the growth of microorganisms, while the color reaction of the indicator presents the degree of biochemical reaction, focusing on the chemical color development results after the microbial metabolism reaches a certain level. Through the coordinated cooperation and mutual verification of the two modal signals of impedance signal and indicator color reaction, the detection sensitivity is greatly improved on the basis of ensuring the accuracy of microbial detection results. At the same time, it can also eliminate misjudgments caused by factors such as ion interference, thereby effectively screening out real microbial signals and significantly enhancing anti-interference ability.

[0069] At the same time, since the present invention can use the impedance signal to respond to the early warning advantage when the microbial metabolic activity just begins to become active, combined with the color reaction of the indicator, it can quickly lock the confirmation time of microbial contamination, significantly shorten the detection cycle, and greatly improve the detection efficiency. It can meet the needs of scenarios with extremely high timeliness requirements such as the rapid release of cell therapy products and online quality inspection in the food industry, effectively shortening production waiting time and improving production efficiency.

[0070] Moreover, the incubation and detection processes of the present invention are both carried out in the incubation chamber 103 of the same detection part 1. The incubation chamber 103 is a relatively independent and stable detection microenvironment, which supports the in-situ addition of indicators through the reagent inlet 102 during the culture process. There is no need to open the detection part 1 or transfer the test liquid, thereby avoiding the risk of contamination that may be introduced during the sampling process and requiring no manual operation throughout the process. It is also flexible and closed, and can realize the mid-way addition of reagents and the synchronous acquisition of multimodal signals in a sterile environment. In this way, the application limitations of the present invention in high-sanitation standard scenarios such as pharmaceutical production and food processing are reduced, the detection error is also reduced, and the standardization and normalization of the detection process are improved.

[0071] In some embodiments, step S300, i.e., determining a microbial detection result based on the real-time modal signal, includes: S301, determining an impedance detection value of the test liquid in the incubation chamber 103 during a current incubation period based on the impedance signal; the current incubation period refers to a period between the initial time point of incubation of the test liquid in the incubation chamber 103 and the current time point; S302, determining the color development detection value of the test liquid in the incubation chamber 103 during the current color development period based on the color verification image; the current color development period refers to the period between the color development start point when the indicator enters the incubation chamber 103 and the current time point; S303: Determine the microorganism detection result according to the preset weight coefficient, the impedance detection value, and the color detection value.

[0072] Understandably, before step S300, the real-time modal signals can be processed and analyzed. Specifically, the controller performs real-time and accurate processing and analysis on received real-time modal signals, including the impedance signal, color verification image, and microscopic verification image. First, filtering and noise reduction are applied to the real-time modal signals to remove any interference, significantly improving data accuracy. Then, a dynamic weight allocation algorithm is introduced to perform deep fusion processing on the real-time modal signals, and the microbial detection results are determined based on the real-time modal signals.

[0073] Furthermore, the preset weight coefficient includes a first weight coefficient and a second weight coefficient; in step S303, determining the microorganism detection result according to the impedance detection value and the color detection value includes: determining the first detection value according to the first detection model, and determining the microorganism detection result according to the first detection value, the first detection model including: W1=α1×Z+β1×C Wherein: W1 is the first detection value; α1 is the first weight coefficient; Z is the impedance detection value; β1 is the second weight coefficient; C is the color detection value.

[0074] In this embodiment, the weight values ​​of α1 and β1 can be set as needed, but the sum of the two needs to be equal to 1. For example, α1 can be set to 0.6, β1 to 0.4, etc. When determining the microbial detection result based on the first detection value, a detection threshold can be pre-set, and then when the first detection value is greater than or equal to the detection threshold, the microbial detection result is determined to be the presence of microorganisms in the test liquid, that is, positive; conversely, when the first detection value is less than the detection threshold, the microbial detection result is determined to be the absence of microorganisms in the test liquid, that is, negative. The detection threshold can be set as needed. For example, if the detection threshold Wth is set to 0.8, the current weight coefficients are α1=0.65, β1=0.35, Z=1, and C=0.5, then the first detection value is W1=0.825; at this time, W1>Wth, so the test liquid is determined to be the test liquid containing microorganisms.

[0075] In some embodiments, the image acquisition device 3 includes a microscopic imaging module 32; in step S100, after controlling the test liquid to be input into the incubation chamber 103 through the injection port 101 for incubation, the following steps are further included: S400, a microscopic verification image of the test liquid in the incubation chamber 103 is collected through the microscopic imaging module 32; understandably, in order to collect the microscopic verification image corresponding to the initial time point, it is necessary to synchronously collect the impedance signal and the microscopic verification image after the test liquid is input into the incubation chamber 103 through the sampling port 101 for incubation, so that after triggering the microscopic verification image review operation, the microbial detection results can be further determined based on the microscopic verification images corresponding to the initial time point and the current time point. In the present invention, the microscopic imaging module 32 images the microbial colony at preset time intervals starting from the initial time point and transmits the acquired microscopic verification image to the controller. The microscopic verification image can intuitively present information such as the morphology, size, and distribution of the microbial colony, providing an important visual basis for subsequent data processing and analysis.

[0076] Specifically, in step S200, after determining the presence of a microbial proliferation trend in the test liquid based on the impedance signal, the indicator is directly controlled to be introduced into the incubation chamber 103 through the reagent inlet 102. After the camera module 31 of the image acquisition device 3 captures a color verification image of the test liquid in the incubation chamber 103, it is determined whether the color verification image within a predetermined color development time (for example, the threshold time for the color development reaction of the resazurin indicator under a metabolically active environment is 4 hours; when the indicator is resazurin, the predetermined color development time may be 4 hours) indicates that the test liquid has undergone a color change corresponding to the preset color change information. If the color verification image within the predetermined color development time indicates that the test liquid has undergone a color change corresponding to the preset color change information, a microscopic verification image review operation is triggered; otherwise, the microscopic imaging detection process is terminated, and the microbial detection result is determined to be negative, indicating that no microorganisms are present in the test liquid. The preset color change information refers to the color change corresponding to the color development reaction that occurs when the indicator contacts the microorganism. For example, for Staphylococcus aureus samples, it is necessary to detect whether the color of the indicator changes from blue to pink within the predetermined color development time (from Figure 23 As can be seen in the figure, when the microbial detection method of the present invention is used to detect Staphylococcus aureus samples, using the color verification images captured by the camera module 31 at different time points, it can be found that the test liquid changes from blue to pink within 14 minutes after the addition of the indicator. Therefore, if the test liquid turns pink within the predetermined color development time, the microscopic verification image review operation is triggered. That is, at this time, the microscopic verification images corresponding to the initial time point and the current time point captured by the microscopic imaging module 32 are used to conduct more detailed observation and analysis of the microbial colonies to further confirm the growth status of the microorganisms, eliminate misjudgments caused by other factors, and improve the accuracy of the test results. If the color does not turn pink within the predetermined color development time, the microscopic imaging detection process is terminated, and the microbial detection result is determined to be the absence of microorganisms in the test liquid. In other words, the microbial detection result is negative, meaning that no microbial growth was detected in the test liquid.

[0077] from Figure 18 It can be seen that when the negative sample (a test solution that does not contain microorganisms) is tested using the microbial detection method of the present invention, no microbial colony growth is found in the microscopic verification image collected by the microscopic imaging module 32; Figure 20 It can be seen from the figure that when the positive sample (the test liquid containing microorganisms) is tested using the microbial detection method of the present invention, microbial colony growth is found in the microscopic verification image collected by the microscopic imaging module 32. Figure 24It can be seen that when the microbial detection method of the present invention is used to detect a positive sample (a test liquid containing microorganisms), the microscopic verification images collected at different time points by the microscopic imaging module 32 show that the microbial colonies gradually grow. Around 7.5 hours from the initial time point, a small number of colonies begin to appear. As the incubation time increases, the number of colonies increases and the area increases.

[0078] Furthermore, in step S300, determining the microbial detection results based on the real-time modal signals includes determining the impedance signal, color verification image, and microscopic verification image as real-time modal signals, and identifying the microbial detection results based on the real-time modal signals. In other words, in this embodiment, the real-time modal signals include the impedance signal, color verification image, and microscopic verification image. The controller performs preprocessing on the received real-time modal signals (including the impedance signal, color verification image, and microscopic verification image) through filtering and noise reduction to remove interference. Simultaneously, a dynamic weight allocation algorithm is used to fuse the multimodal signals, comprehensively considering the data provided by different real-time modal signals. This ensures that the analysis results more comprehensively and accurately reflect the actual microbial growth status. Based on the comprehensive score obtained through data processing and analysis, the microbial growth status is determined and the microbial detection results are obtained. Taking a Staphylococcus aureus sample as an example, the three real-time modal signal changes were analyzed. The impedance signal changes reflect changes in the ion concentration of the test liquid caused by the metabolic activity of S. aureus; the color change of the test liquid caused by the color reaction of the indicator directly reveals the proliferation of S. aureus; and the microscopic verification image visually displays the colony morphology and development process of S. aureus. These three modal signals mutually confirm each other, accurately determining the growth status and metabolic activity of S. aureus, verifying the high-efficiency detection performance of the present invention.

[0079] In some embodiments, identifying microbial detection results based on real-time modality signals includes: S301, determining an impedance detection value of the test liquid in the incubation chamber 103 during a current incubation period based on the impedance signal; the current incubation period refers to a period between the initial time point of incubation of the test liquid in the incubation chamber 103 and the current time point; S302, determining the color development detection value of the test liquid in the incubation chamber 103 during the current color development period based on the color verification image; the current color development period refers to the period between the color development start point when the indicator enters the incubation chamber 103 and the current time point; S304, determining the colony detection value of the test solution in the incubation chamber 103 during the current incubation period based on the microscopic verification image; S305 , determining a microbial detection result according to a preset weight coefficient, an impedance detection value, a color development detection value, and a colony detection value.

[0080] Understandably, before step S300, the real-time modal signals can be processed and analyzed. Specifically, the controller performs real-time and accurate processing and analysis on received real-time modal signals, including the impedance signal, color verification image, and microscopic verification image. First, filtering and noise reduction are applied to the real-time modal signals to remove any interference, significantly improving data accuracy. Then, a dynamic weight allocation algorithm is introduced to perform deep fusion processing on the real-time modal signals, and the microbial detection results are determined based on the real-time modal signals.

[0081] Furthermore, the preset weight coefficients include a third weight coefficient, a fourth weight coefficient, and a fifth weight coefficient; in step S305, the microorganism detection result is determined according to the preset weight coefficients, the impedance detection value, the color detection value, and the colony detection value, including: Determine a second detection value according to a second detection model, and determine a microorganism detection result according to the second detection value, wherein the second detection model includes: W2=α2×Z+β2×C+γ×M Wherein: W2 is the second detection value; α2 is the third weight coefficient; Z is the impedance detection value; β2 is the fourth weight coefficient; C is the color detection value; γ is the fifth weight coefficient; M is the colony detection value.

[0082] In this embodiment, the weight values ​​of α2, β2, and γ can be set as needed, but the sum of the three needs to be equal to 1. For example, α2 can be set to 0.5, β2 to 0.3, and γ to 0.2. When determining the microbial detection result based on the second detection value, a detection threshold can be pre-set, and then when the second detection value is greater than or equal to the detection threshold, the microbial detection result is determined to be the presence of microorganisms in the test liquid, that is, positive; conversely, when the second detection value is less than the detection threshold, the microbial detection result is determined to be the absence of microorganisms in the test liquid, that is, negative. The detection threshold can be set as needed. For example, if the detection threshold Wth is set to 0.8, the current weight coefficients are α2=0.5, β2=0.3, γ=0.2, Z=1, C=0.5, and M=1, then the second detection value is W2=0.85; at this time, W2>Wth, so the test liquid is determined to be the test liquid containing microorganisms.

[0083] In some embodiments, step S301, i.e., determining the impedance detection value of the test liquid in the incubation chamber 103 during the current incubation period according to the impedance signal, includes: Determine an initial impedance value based on the impedance signal at the initial time point, determine a current impedance value based on the impedance signal at the current time point, and obtain an impedance change between the current impedance value and the initial impedance value; When the absolute value of the impedance change is greater than or equal to the preset impedance change, the impedance detection value is determined to be 1; When the absolute value of the impedance change is less than the preset impedance change, the impedance detection value is determined to be 0; In this embodiment, first, the initial impedance value corresponding to the impedance signal of the test liquid at the initial time point at the beginning of the incubation phase is accurately measured (the initial impedance value is set to the impedance amplitude Z0). Then, based on Z0, the change ΔZ=Z−Z0 of the impedance amplitude corresponding to the impedance signal at the current time point relative to the initial impedance value is accurately calculated. If |ΔZ| / Z0≥5%, then Z=1; otherwise, Z=0.

[0084] In some embodiments, step S302, i.e., determining the color development detection value of the test liquid in the incubation chamber 103 in the current color development period according to the color verification image, includes: Determine an initial hue value based on a color calibration image at a color development starting point, determine an actual hue value based on a color calibration image at a current time point, and determine a valid hue value of the actual hue value based on a valid hue range; Get the hue change between the effective hue value and the initial hue value; The color detection value is determined based on the hue change amount and the effective hue range.

[0085] In this embodiment, the color verification image (RGB image) is first accurately converted to HSV space, and the initial hue value H0 is extracted. Next, the actual hue value H1 corresponding to the color verification image at the current time point is extracted. The actual hue value H1 is then compared with the valid hue range to determine the valid hue value H2. Specifically, when the actual hue value H1 falls within the valid hue range, the valid hue value H2 is equal to the actual hue value H1. When the actual hue value H1 is greater than the maximum value Hmax of the valid hue range, the valid hue value H2 is equal to the maximum value Hmax of the valid hue range. When the actual hue value H1 is less than the minimum value Hmin of the valid hue range, the valid hue value H2 is equal to. For example, the valid hue range is blue (H=240) to pink (H=360), i.e., Hmin=240 and Hmax=360. At this time, when the actual hue value H1>360, the effective hue value H2=360; when the actual hue value H1<240, the effective hue value H2=240, to ensure that the color detection value C is always in the [0, 1] interval. Further, the color detection value can be determined using the following color detection model. The color detection model includes: C=ΔH / (Hmax-Hmin) Where C is the color detection value; ΔH is the hue change, ΔH = H2 - H0; Hmax is the maximum value of the valid hue range; Hmin is the minimum value of the valid hue range. If the initial hue values ​​H0 = 240 and H1 = 300, then H2 = H1 = 300, and C = 0.5.

[0086] In some embodiments, step S304, i.e., determining the colony detection value of the test liquid in the incubation chamber 103 during the current incubation period based on the microscopic verification image, includes: Determine the total number of initial colonies and the initial colony area within a preset field of view based on the microscopic verification image at the initial time point; Determine the total number of current colonies and the current colony area within a preset field of view based on the microscopic verification image at the current time point; Obtain the difference in colony count between the current total colony count and the initial total colony count, as well as the difference in colony area between the current colony area and the initial colony area; When the difference in colony number is greater than or equal to 1 and the difference in colony area is greater than 0, the colony detection value is determined to be 1; When the difference in colony number is less than 1, or the difference in colony area is less than or equal to 0, the colorimetric detection value is determined to be 0.

[0087] In this embodiment, the initial total colony count N0 and initial colony area A0 within a preset field of view are first accurately counted. Next, the difference ΔN = N1 − N0 between the current total colony count N1 and the initial total colony count N0, as well as the difference ΔA = A1 − A0 between the current colony area A1 and the initial colony area A0, corresponding to the current time point, are calculated. If ΔN ≥ 1 and ΔA > 0, then M = 1; otherwise, M = 0.

[0088] In this embodiment, the initial total colony count, initial colony area, current total colony count, and current colony area are obtained as follows: First, the microscopic verification image is preprocessed. Image preprocessing can include filtering, noise reduction, and contrast enhancement. For example, filtering, noise reduction, and other methods, such as median filtering and Gaussian filtering, are used to remove image noise and reduce interference. Contrast enhancement techniques, such as histogram equalization and limited contrast adjustment, are used to enhance the contrast between the colonies and the background, making the colonies more visible. Next, colony identification and segmentation are performed, including threshold segmentation, which involves selecting one or more appropriate grayscale thresholds based on the grayscale histogram of the preprocessed microscopic verification image to separate the colonies from the background; edge detection, which utilizes edge detection algorithms such as the Sobel operator and the Canny operator to highlight colony boundaries and achieve precise colony location; and machine learning, which involves classifying and identifying images using deep learning algorithms such as convolutional neural networks (CNNs), automatically learning colony features, and improving recognition accuracy and robustness. Finally, colony counting and area calculation are performed, which specifically includes: connected domain analysis, that is, using the connected domain labeling algorithm to analyze the microscopic verification image after threshold segmentation to count the number of colonies (including the initial total number of colonies and the current total number of colonies); area measurement, that is, by calculating the number of pixels of each colony and converting it based on the resolution of the microscopic verification image, the actual area of ​​the colony (including the initial colony area and the current colony area) is obtained.

[0089] In some embodiments, the method further comprises: When it is determined that at least one of the real-time modal signals has a preset quality defect, lowering a preset weight coefficient corresponding to the real-time modal signal having the preset quality defect; When it is determined that at least one of the real-time modal signals has a preset quality advantage, a preset weight coefficient corresponding to the real-time modal signal having a preset quality defect is increased.

[0090] In this embodiment, the preset weight coefficients can be dynamically adjusted based on the quality assessment results of each modal signal. Specifically, if the current quality of a modal signal (including the impedance signal, color verification image, and microscopic verification image) is poor, it can be considered to have a preset quality defect, and the corresponding weight coefficient (e.g., the first weight coefficient, the second weight coefficient, the third weight coefficient, the fourth weight coefficient, and the fifth weight coefficient) can be reduced. Conversely, if the signal quality is good, it can be considered to have a preset quality advantage, and its weight coefficient can be appropriately increased.

[0091] Specifically, the preset quality defects may include: The impedance amplitude change is too small. If the absolute value of the ratio of the impedance difference (the difference between the impedance signal and the initial impedance value) to the initial impedance value is consistently below the preset impedance drop threshold, this may indicate interference with the impedance signal or weak microbial metabolic activity, resulting in a weak signal. In this case, the impedance signal is considered poor quality and has a preset quality defect. The corresponding first or third weight coefficient may be reduced (the remaining preset weight coefficients can be increased accordingly).

[0092] The impedance signal is unstable or noisy. If the impedance signal fluctuates frequently and significantly, rather than showing a regular trend (such as a gradual decrease or increase) with microbial growth, and filtering and other processing methods do not effectively improve it, this may be due to interference factors such as electrode contamination or abnormal fluctuations in the ion concentration of the test liquid. In this case, the impedance signal quality has deteriorated and a preset quality defect exists. The corresponding first or third weight coefficient may be reduced (the other preset weight coefficients can be increased accordingly).

[0093] The signal-to-noise ratio of the color verification image suddenly drops significantly. Specifically, the signal-to-noise ratio of the region of interest can be calculated. If the signal-to-noise ratio is less than 10, it is judged as low quality, indicating severe interference and the presence of preset quality defects. In this case, the second or fourth weight coefficient corresponding to the color verification image can be reduced (the remaining preset weight coefficients can be increased accordingly) to reduce the impact of the color verification image on the modal fusion results, increase the contribution of the impedance signal and the microscopic verification image signal, and thus reduce the negative impact of the color verification image quality decline on the microbial detection results.

[0094] Abnormal changes in colony count and area: When both the colony count difference and the colony area difference corresponding to the microscopic verification image are less than 1 and less than or equal to 0, the microscopic verification image quality is considered poor and has a preset quality defect. For example, under normal microbial growth, both the colony count and colony area are expected to increase. However, if the microscopic verification image shows no increase in colony count (colony count difference less than 1) and no increase in colony area (colony area difference less than or equal to 0), this may indicate that the microscopic verification image is contaminated, the image clarity is insufficient, or there is a deviation in the image processing algorithm, resulting in an inability to accurately capture the growth of the colonies. In this case, the microscopic verification image signal quality is poor, and the corresponding fifth weight coefficient γ should be reduced (the other preset weight coefficients can be increased accordingly).

[0095] Blurred images or unclear colony features: If the microscopic verification image cannot clearly discern the outline and morphology of the colonies due to inaccurate focus, motion blur, or poor lighting conditions, this affects the accurate counting of colony counts and areas. This also constitutes a case of poor microscopic verification image signal quality and a pre-defined quality defect. In this case, even with image processing algorithms for enhancement and repair, it is still difficult to obtain reliable colony information. In this case, the fifth weight coefficient γ should be reduced (the other pre-defined weight coefficients can be increased accordingly) to reduce the weight of the microscopic verification image signal in the comprehensive score.

[0096] Specifically, the preset quality advantages may include: The impedance amplitude changes significantly and stably (the absolute value of the ratio of the impedance difference (the impedance difference between the impedance signal and the initial impedance value) to the initial impedance value exceeds the preset impedance drop threshold), and the impedance change curve corresponding to the impedance signal (such as Figure 21 For example, for most microorganisms, the electrical impedance will gradually decrease as their metabolic activity increases, and the curve is smooth without abnormal fluctuations. At this time, the impedance signal quality is high and there is a preset quality advantage. The corresponding first weight coefficient or third weight coefficient should be appropriately increased (the other preset weight coefficients can be adjusted down accordingly) to increase its weight in the evaluation of microbial detection results.

[0097] The hue value of the color verification image changes according to the expected indicator color reaction pattern, and the range of hue value changes is within the valid hue range (between 240 and 360). At the same time, the calculated C is close to or equal to 1, indicating that the color reaction corresponding to the color verification image is of good quality and has a preset quality advantage. For example, after adding the indicator, the color of the test liquid changes from blue (H=240) to pink (H=360) within a short period of time (e.g., 10-15 minutes), and the color change is uniform, corresponding to C=1. At this time, the color reaction signal quality is high, and the second weight coefficient or fourth weight coefficient corresponding to the color verification image should be appropriately increased (the other preset weight coefficients can be adjusted accordingly) to increase its weight in the assessment of microbial detection results.

[0098] The microscopic verification image clearly shows an increase in the number of colonies (the difference in the number of colonies is greater than or equal to 1) and an increase in the area of ​​the colonies (the difference in the area of ​​the colonies is greater than 0), and the morphological characteristics of the colonies are obvious and the distribution is reasonable. In this case, the microscopic verification image signal quality is high and has a preset quality advantage. For example, in the microscopic verification image, it can be clearly observed that the number of colonies increases from an initial few to multiple over time, and the area of ​​each colony increases significantly. The statistically obtained M=1 indicates that the microscopic verification image signal can accurately reflect the growth status of the microorganisms. The corresponding fifth weight coefficient γ should be increased (the other preset weight coefficients can be adjusted accordingly) to increase its contribution to the assessment of microbial detection results.

[0099] In the above embodiment, the core goal of the dynamic weight allocation algorithm is to comprehensively evaluate the quality and reliability of the three modal signals: impedance signal, color verification image, and microscopic verification image, dynamically adjust the preset weight coefficient of each modality, effectively solve complex problems such as signal conflict and noise interference, and ultimately achieve the optimal fusion of multimodal data, thereby comprehensively improving the accuracy and robustness of microbial detection.

[0100] The present invention proposes a microbial detection method that combines three modal signals: electrical impedance, indicator color, and microscopic verification images of colonies. This method cleverly breaks through the limitations of traditional single detection modes. By comprehensively utilizing three different dimensional signals: the impedance signal change of the test liquid caused by the microbial metabolism process, the indicator color change caused by the redox reaction, and the unique morphological characteristics of the microbial colonies, it realizes all-round, multi-angle, real-time dynamic monitoring of the microbial growth status. The detection methods corresponding to the three modal signals complement and confirm each other, greatly improving the sensitivity and accuracy of the detection. It can accurately identify low-concentration microorganisms and subtle changes in the microbial growth process, providing a comprehensive and reliable detection method for microbial detection, and ensuring the credibility and effectiveness of the test results.

[0101] The present invention ensures detection accuracy through a carefully designed cascade verification and intelligent triggering mechanism. Its workflow closely revolves around the different stages and characteristics of microbial growth. First, the impedance change caused by microbial metabolic activity is detected in real time based on the impedance signal. The amplitude change threshold in the impedance change curve is accurately identified as the key basis for judging the initiation of microbial metabolic activity. Then, when the absolute value of the ratio between the impedance difference and the initial impedance value exceeds the preset impedance drop threshold, it is determined that there is a microbial proliferation trend in the test liquid and the indicator colorimetric method is automatically triggered to monitor the color reaction. The intuitive characteristics of color change are used as a key indicator to further verify the presence of microorganisms. Finally, the morphological characteristics of microbial colonies are deeply analyzed through microscopic imaging technology, and key information such as the size, shape and number of colonies are accurately identified. This serves as the decisive basis for finally confirming the type and growth status of the microorganism. These triple verification logic gates work together and are closely connected, making the detection results highly reliable and accurate, effectively reducing the misjudgment rate, and providing a solid technical guarantee for microbial detection.

[0102] It should be understood that the size of the serial numbers of the steps in the above embodiments does not mean the order of execution. The execution order of each process should be determined by its function and internal logic, and should not constitute any limitation on the implementation process of the embodiments of the present invention.

[0103] The above are merely embodiments of the microbial detection device, system, and method of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A microorganism detection device, characterized in that: include: The detection element is provided with a sample inlet, a reagent inlet, and an incubation chamber communicating with the sample inlet and the reagent inlet; an electrode assembly, at least a portion of which is located in the incubation chamber; The electrode assembly is used to collect the impedance signal of the liquid to be tested in the incubation chamber after the liquid to be tested is input into the incubation chamber through the sampling port for incubation; the reagent inlet is used to allow the indicator to enter the incubation chamber after determining the presence of a microbial proliferation trend in the liquid to be tested based on the impedance signal.

2. The microorganism detection device according to claim 1, characterized in that The detection element includes a detection body, a first liquid inlet tube and a second liquid inlet tube; the sampling port, the reagent inlet and the incubation chamber are all arranged on the detection body, one end of the first liquid inlet tube is connected to the sampling port, and the other end is connected to the sampling container for holding the liquid to be tested; one end of the second liquid inlet tube is connected to the reagent inlet, and the other end is connected to the reagent container for holding the indicator.

3. The microorganism detection device according to claim 1, characterized in that The detection element includes a detection body, a sealing component and a reagent vesicle; the injection port, the reagent inlet and the incubation chamber are all arranged on the detection body, and the sealing component is installed on the injection port; the reagent vesicle is installed on the reagent inlet and is used to contain an indicator.

4. The microorganism detection device according to claim 3, characterized in that The sealing assembly comprises a flexible rubber plug sealingly mounted in the injection port, and a sealing cover covering the flexible rubber plug; and / or The detection member further includes a supporting member disposed in the reagent inlet and used to support the reagent vesicle, the supporting member being provided with a liquid inlet through-hole communicating with the incubation chamber; a capsule rupture member is provided on the end surface of the supporting member facing the reagent vesicle, the capsule rupture member being used to puncture the reagent vesicle when squeezed by the reagent vesicle to allow the indicator to flow into the incubation chamber through the liquid inlet through-hole; and / or The detection element also includes a protective cover covering the reagent vesicle.

5. The microorganism detection device according to claim 2 or 3, characterized in that: The detection body includes a cover and a box body with an opening. The cover is detachably mounted on the opening, and the incubation chamber is formed between the cover and the box body.

6. The microorganism detection device according to claim 1, characterized in that: The electrode assembly includes a first electrode and a second electrode; The first electrode and the second electrode are arranged on opposite sides of the detection element, or the first electrode and the second electrode are arranged on the same side of the detection element.

7. A microorganism detection system, characterized in that: The apparatus comprises an image acquisition device, a controller, and the microorganism detection device according to any one of claims 1 to 6; the controller is connected to the electrode assembly and the image acquisition device, and the image acquisition device is used to acquire a color verification image of the liquid to be tested in the incubation chamber after the indicator is input into the incubation chamber through the reagent inlet.

8. The microorganism detection system according to claim 7, characterized in that: The image acquisition device includes a microscopic imaging module, which is used to acquire a microscopic verification image of the test liquid in the incubation chamber after the color verification image indicates that the test liquid has a color change corresponding to preset color change information; and / or The microorganism detection system further includes a sample injection container and / or a reagent container.

9. A method for detecting microorganisms, characterized in that: Applied to the microbial detection system according to claim 7, the method comprises: Controlling the test liquid to be input into the incubation chamber through the sampling port for incubation, and collecting the impedance signal of the test liquid in the incubation chamber through the electrode assembly; After determining that there is a microbial proliferation trend in the test liquid according to the impedance signal, controlling the indicator to be input into the incubation chamber through the reagent inlet, and capturing a color verification image of the test liquid in the incubation chamber through an image acquisition device; A microorganism detection result is determined based on a real-time modal signal, wherein the real-time modal signal includes the impedance signal and the color calibration image.

10. The microorganism detection method according to claim 9, characterized in that: Determining the presence of a microbial proliferation trend in the test liquid according to the impedance signal includes: Obtaining an initial impedance value corresponding to an initial time point of incubation of the test liquid in the incubation chamber, and determining an impedance difference between the impedance signal and the initial impedance value; When the absolute value of the ratio of the impedance difference to the initial impedance value exceeds a preset impedance drop threshold, it is determined that there is a microbial proliferation trend in the test liquid.

11. The microorganism detection method according to claim 9, characterized in that: Determining the microbial detection result based on the real-time modal signal includes: Determine an impedance detection value of the test liquid in the incubation chamber during a current incubation period according to the impedance signal; the current incubation period refers to a period between an initial time point and a current time point of incubation of the test liquid in the incubation chamber; Determining the color development detection value of the test liquid in the incubation chamber during the current color development period according to the color verification image; the current color development period refers to the period between the color development starting point when the indicator enters the incubation chamber and the current time point; The microorganism detection result is determined according to a preset weight coefficient, the impedance detection value and the color detection value.

12. The microorganism detection method according to claim 11, characterized in that: The preset weight coefficients include a first weight coefficient and a second weight coefficient; Determining the microorganism detection result according to the impedance detection value and the color development detection value includes: Determine a first detection value according to a first detection model, and determine the microorganism detection result according to the first detection value, wherein the first detection model includes: W1=α1×Z+β1×C in: W1 is the first detection value; α1 is the first weight coefficient; Z is the impedance detection value; β1 is the second weight coefficient; C is the color detection value.

13. The microorganism detection method according to claim 9, characterized in that: The image acquisition device includes a microscopic imaging module; After the test solution is controlled to be input into the incubation chamber through the sample inlet for incubation, the method further comprises: Acquiring a microscopic verification image of the test liquid in the incubation chamber by a microscopic imaging module; Determining the microbial detection result based on the real-time modal signal includes: The impedance signal, the color verification image, and the microscopic verification image are determined as the real-time modality signal, and a microorganism detection result is identified based on the real-time modality signal.

14. The microorganism detection method according to claim 13, characterized in that: The identifying of the microorganism detection result based on the real-time modal signal includes: Determine an impedance detection value of the test liquid in the incubation chamber during a current incubation period according to the impedance signal; the current incubation period refers to a period between an initial time point and a current time point of incubation of the test liquid in the incubation chamber; Determining the color development detection value of the test liquid in the incubation chamber during the current color development period according to the color verification image; the current color development period refers to the period between the color development starting point when the indicator enters the incubation chamber and the current time point; determining a colony detection value of the test liquid in the incubation chamber during the current incubation period according to the microscopic verification image; The microorganism detection result is determined according to a preset weight coefficient, the impedance detection value, the color development detection value and the colony detection value.

15. The microorganism detection method according to claim 14, characterized in that: The preset weight coefficients include a third weight coefficient, a fourth weight coefficient and a fifth weight coefficient; The determining of the microorganism detection result according to the preset weight coefficient, the impedance detection value, the color development detection value, and the colony detection value includes: Determine a second detection value according to a second detection model, and determine the microorganism detection result according to the second detection value, wherein the second detection model includes: W2=α2×Z+β2×C+γ×M in: W2 is the second detection value; α2 is the third weight coefficient; Z is the impedance detection value; β2 is the fourth weight coefficient; C is the color detection value; γ is the fifth weight coefficient; M is the colony detection value.

16. The microorganism detection method according to claim 11 or 14, characterized in that: Determining the impedance detection value of the test liquid in the incubation chamber during the current incubation period according to the impedance signal includes: Determining an initial impedance value according to the impedance signal at the initial time point, and determining a current impedance value according to the impedance signal at the current time point, and obtaining an impedance change between the current impedance value and the initial impedance value; When the absolute value of the impedance change is greater than or equal to a preset impedance change, determining the impedance detection value to be 1; When the absolute value of the impedance change is less than a preset impedance change, determining the impedance detection value to be 0; Determining the color development detection value of the test liquid in the incubation chamber in the current color development period according to the color verification image includes: Determining an initial hue value based on the color verification image at the color development starting point, determining an actual hue value based on the color verification image at the current time point, and determining a valid hue value of the actual hue value based on a valid hue range; Obtaining a hue change between the effective hue value and the initial hue value; The color development detection value is determined according to the hue change amount and the effective hue range.

17. The microorganism detection method according to claim 14, characterized in that: Determining the colony detection value of the test liquid in the incubation chamber during the current incubation period according to the microscopic verification image includes: Determine the initial total number of bacterial colonies and the initial bacterial colony area within a preset visual field according to the microscopic verification image at the initial time point; Determine the total number of current bacterial colonies and the current bacterial colony area within the preset visual field according to the microscopic verification image at the current time point; Obtaining a colony count difference between the current total colony count and the initial total colony count, and a colony area difference between the current colony area and the initial colony area; When the colony number difference is greater than or equal to 1, and the colony area difference is greater than 0, the colony detection value is determined to be 1; When the difference in the number of colonies is less than 1, or the difference in the area of ​​colonies is less than or equal to 0, the color development detection value is determined to be 0.

18. The microorganism detection method according to claim 11 or 14, characterized in that: The method further comprises: When it is determined that at least one of the real-time modal signals has a preset quality defect, lowering a preset weight coefficient corresponding to the real-time modal signal having the preset quality defect; When it is determined that at least one of the real-time modal signals has a preset quality advantage, a preset weight coefficient corresponding to the real-time modal signal having the preset quality defect is increased.

Images