Detection system based on plate agglutination test and agglutination detection method

By installing a detection system with a light source and light intensity sensor below the agglomeration plate, the problems of low efficiency and poor accuracy in traditional plate agglomeration tests are solved, achieving low-cost and high-efficiency detection and judgment of agglomeration reactions.

CN120870548APending Publication Date: 2025-10-31SUZHOU XINSHI MEDICAL TECH CO LTD +2
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Patent Information

Application Number
CN202510999209.1
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-07-18
Publication Date
2025-10-31

AI Technical Summary

Technical Problem

Traditional plate agglutination tests are inefficient, costly, and prone to errors, with human error leading to inaccurate test results.

Method used

A detection system based on a light intensity sensor is adopted. By setting a light source and a light intensity sensor under the agglomeration plate, the agglomeration result is determined by the change in light intensity. Combined with an automatic sample dispensing mechanism, the detection efficiency and accuracy are improved.

Benefits of technology

It reduces system hardware and software costs, enables digital description of the agglomeration reaction and analyzable result determination, can fully describe the agglomeration process, and improves the accuracy and efficiency of detection.

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Abstract

The invention discloses a detection system based on a plate agglutination test and an agglutination detection method, the system comprises a plurality of detection units, each detection unit comprises: an agglutination plate having a transparent carrying part for carrying a sample to be detected and an antibody reagent; the uncovered detection grid is arranged below the agglutination plate, and a detection cavity with a non-transparent structure is formed between the detection grid and the agglutination plate; the light source is used for illumination and is arranged in the detection cavity; the light intensity sensor is arranged in the detection cavity; and the processor is electrically connected with the light intensity sensor and is configured to judge the agglutination result of the sample to be detected and the antibody reagent according to the light intensity detected by the light intensity sensor. According to the invention, only small and exquisite light intensity sensors are needed to be in one-to-one correspondence with the detection units, an expensive and huge high-definition camera is not needed, and the complexity of a detection system and the software and hardware cost of the system are reduced.
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Description

Technical Field

[0001] This invention relates to the field of medical testing equipment, and in particular to a detection system and agglutination detection method based on a plate agglutination test. Background Technology

[0002] The plate agglutination test is a commonly used laboratory detection method for diagnosing pathogenic microorganisms such as bacteria. Clinical testing institutions and inspection and quarantine institutions often use the plate agglutination test for rapid screening and detection of Brucella and Salmonella.

[0003] The plate agglutination test procedure is roughly as follows: First, a quantitative sample (usually serum or whole blood) that may contain pathogens such as bacteria and a known antibody reagent (also quantitative, the type of antibody reagent being selected according to the type of bacteria to be screened) are added to a clean glass slide; second, the sample and antibody reagent are placed in a specific area (usually 1–1.5 cm) on the glass slide. 2 Mix thoroughly; after mixing, wait 4-5 minutes for the agglutination reaction to occur, and then determine whether agglutination has occurred. Different reaction phenomena may appear depending on the degree of reaction between the sample and the antibody reagent. Figures 1 to 5 This diagram represents five states of aggregation, from weakest to strongest. Figure 1 The droplets shown are uniformly pink, indicating no agglutination, meaning the sample did not react with the antibody reagent, and thus the sample is negative; Figure 2 The droplet shown has a slight curled edge around its edge, and a small amount of agglomeration can be seen in the center of the droplet. The droplets between the agglomerates are red, indicating that the sample is weakly positive. Figure 3 The droplet shown has a distinct rolled edge around its perimeter, and the central part of the droplet is slightly clear, indicating that the sample is weakly positive. Figure 4 The droplet shown has a distinct rolled edge around its edge and a slight appearance of bacterial clusters. The droplets between the clusters are almost completely transparent, indicating that the sample is positive. Figure 5 The droplets shown exhibit a cluster-like agglomerate pattern, with large agglomerates or small granules. The droplets between the agglomerates are completely transparent, indicating a strong positive result for the sample.

[0004] Traditional, fully manual plate agglutination tests are not only inefficient and have low throughput, but also pose potential biohazards. Furthermore, human error can lead to incorrect results, as can differences in visual perception, subjective judgment, and poor observation conditions. To address these shortcomings, researchers are attempting to replace manual operation with high-throughput, fully automated sample loading equipment and utilize machine vision technology to replace human judgment in determining agglutination results. This involves using a high-definition camera to acquire images of the agglutination reaction plate, followed by image processing techniques to analyze and determine the agglutination outcome.

[0005] The above background information is provided only to aid in understanding the concept and technical solution of this application. It does not necessarily belong to the prior art of this application, nor does it necessarily provide technical guidance. In the absence of clear evidence that the above information was disclosed before the filing date of this application, the above background information should not be used to evaluate the novelty and inventiveness of this application. Summary of the Invention

[0006] The purpose of this invention is to provide an agglutination detection system with a simple structure and reduced hardware and software costs.

[0007] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0008] A detection system based on a plate agglutination test includes several detection units, each detection unit comprising:

[0009] Agglutination plate having a carrier for holding the sample to be tested and antibody reagents, said carrier being a transparent structure;

[0010] An uncovered detection grid is disposed below the agglomeration plate, forming a detection cavity between the detection grid and the agglomeration plate, and the detection grid is a non-transparent structure;

[0011] A light source for illumination is disposed within the detection cavity;

[0012] A light intensity sensor is disposed inside the detection cavity;

[0013] A processor, electrically connected to the light intensity sensor, is configured to determine the agglutination result of the sample to be tested and the antibody reagent based on the light intensity detected by the light intensity sensor.

[0014] Furthermore, in accordance with any or a combination of the aforementioned technical solutions, the support portion of the agglomeration plate has a concave structure.

[0015] Furthermore, in accordance with any or a combination of the aforementioned technical solutions, the center of the recessed structure of the support portion is positioned opposite to the receiving end of the light intensity sensor;

[0016] And / or, the optical axis of the light source points to the center of the recessed structure of the support portion;

[0017] And / or, the light source is a ring-shaped light source.

[0018] Furthermore, in accordance with any or a combination of the aforementioned technical solutions, the detection system based on the plate agglomeration test provided by the present invention further includes a support base for supporting the detection grids of each detection unit, wherein the agglomeration plate is disposed on the detection grids.

[0019] Furthermore, in accordance with any or a combination of the aforementioned technical solutions, the detection system further includes a cover plate disposed above the agglomeration plate.

[0020] Furthermore, following any one or a combination of the aforementioned technical solutions, the agglomeration plates of multiple detection units are integrated into a single glass slide, and the detection system is equipped with one or more glass slides of the same specifications.

[0021] Furthermore, following any one or a combination of the aforementioned technical solutions, the number of detection units is multiple, and they are arranged in a matrix.

[0022] The detection system also includes an automatic sample dispensing mechanism, which is equipped with one or a row or matrix of sample dispensing heads and a drive device for moving the sample dispensing heads.

[0023] Furthermore, following any one or a combination of the aforementioned technical solutions, the agglutination result of the sample to be tested and the antibody reagent is determined by any of the following methods:

[0024] Method 1 involves configuring the light intensity sensor to detect light intensity after a preset time interval to obtain the current light intensity value; based on a preset light intensity threshold range corresponding to the degree of agglutination, the processor determines the light intensity threshold range in which the current light intensity value falls, thereby determining the degree of agglutination between the sample to be tested and the antibody reagent;

[0025] Method 2 involves configuring the light intensity sensor to detect the light intensity in the initial state after the sample to be tested and the antibody reagent are mixed, obtaining an initial light intensity value; and to detect the light intensity after a preset reaction time, obtaining a termination light intensity value; the processor compares the initial light intensity value and the termination light intensity value to determine the degree of agglomeration of the sample to be tested and the antibody reagent.

[0026] Method 3 involves configuring the light intensity sensor to perform real-time light intensity detection on the state of the sample to be tested after mixing with the antibody reagent, and obtaining a real-time light intensity value; the processor determines a light intensity change curve based on the real-time light intensity value, and then determines the degree and progress history of agglutination of the sample to be tested and the antibody reagent based on one or more of the shape, rate of decrease, and inflection point of the light intensity change curve.

[0027] Furthermore, in accordance with any or a combination of the aforementioned technical solutions, the detection system based on the plate agglutination test provided by the present invention further includes a display electrically connected to the processor, which is configured to display the agglutination results corresponding to each detection unit.

[0028] According to another aspect of the present invention, a method for detecting plate agglutination is provided, comprising the following steps:

[0029] An opaque detection chamber is set below the transparent agglomeration plate, and a light source and a light intensity sensor are set inside the detection chamber;

[0030] Add the sample to be tested and antibody reagent to the agglutination plate and mix them;

[0031] Turn on the light source and use a light intensity sensor to detect the light intensity information;

[0032] The agglutination result of the sample to be tested and the antibody reagent is determined based on the light intensity detected by the light intensity sensor.

[0033] Furthermore, based on any one or a combination of the aforementioned technical solutions, the agglomeration plates and detection chambers are multiple and correspond one-to-one;

[0034] Add the sample to be tested and the antibody reagent to each agglutination plate, with the two added at separate points;

[0035] After all agglutination plates have been added, all agglutination plates are moved or rotated synchronously, so that the sample to be tested and the antibody reagent flow on the agglutination plates.

[0036] Furthermore, following any one or a combination of the aforementioned technical solutions, the agglutination result of the sample to be tested and the antibody reagent is determined by any of the following methods:

[0037] Method 1 involves configuring the light intensity sensor to detect light intensity after a preset time interval to obtain the current light intensity value; determining the light intensity threshold range in which the current light intensity value falls based on a preset light intensity threshold range corresponding to the degree of agglutination, thereby determining the degree of agglutination between the sample to be tested and the antibody reagent;

[0038] Method 2 involves configuring the light intensity sensor to detect the light intensity in the initial state after the sample to be tested and the antibody reagent are mixed, obtaining an initial light intensity value; and to detect the light intensity after a preset reaction time, obtaining a termination light intensity value; and to compare the initial light intensity value and the termination light intensity value to determine the degree of agglomeration of the sample to be tested and the antibody reagent.

[0039] Method 3 involves configuring the light intensity sensor to perform real-time light intensity detection on the state of the sample to be tested after mixing with the antibody reagent, and obtaining a real-time light intensity value; determining a light intensity change curve based on the real-time light intensity value, and then determining the degree and progress history of agglutination of the sample to be tested and the antibody reagent based on one or more of the shape, rate of decrease, and inflection point of the light intensity change curve.

[0040] The beneficial effects of the technical solution provided by this invention are as follows:

[0041] a. No expensive and bulky high-definition camera is required. Only small light intensity sensors corresponding to the detection units are needed to determine the agglomeration results, reducing the complexity of the detection system and the system hardware and software costs.

[0042] b. Compared to machine vision, which can only output a qualitative result (negative / positive), this invention can fully describe the change history of the agglutination reaction process in about 4 minutes, forming an analyzable and evaluable digital description, and extracting the strength characteristics of the agglutination reaction. Attached Figure Description

[0043] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0044] Figure 1 This is a diagram showing the first state of aggregation, from weakest to strongest.

[0045] Figure 2 This is a diagram showing the second state from weakest to strongest aggregation.

[0046] Figure 3 This is a diagram showing the third state, from weakest to strongest aggregation.

[0047] Figure 4 This is a diagram showing the fourth state, from weakest to strongest aggregation.

[0048] Figure 5 This is the fifth state diagram, representing the degree of aggregation from weakest to strongest.

[0049] Figure 6 A three-dimensional schematic diagram of a detection system based on a plate agglutination test provided as an exemplary embodiment of the present invention;

[0050] Figure 7 for Figure 6 A side sectional view of a detection system based on a plate agglomeration test;

[0051] Figure 8 A schematic flowchart of a plate agglomeration detection method provided as an exemplary embodiment of the present invention;

[0052] Figure 9 A light intensity variation curve corresponding to a negative sample is provided as an exemplary embodiment of the present invention;

[0053] Figure 10 A light intensity variation curve corresponding to a positive sample provided as an exemplary embodiment of the present invention. Detailed Implementation

[0054] To enable those skilled in the art to better understand the present invention, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of the present invention.

[0055] It should be noted that the terms "first," "second," etc., in the specification, claims, and accompanying drawings of this invention are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of the invention described herein can be implemented in orders other than those illustrated or described herein. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover a non-exclusive inclusion; for example, a process, method, apparatus, product, or device that comprises a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or devices.

[0056] In one embodiment of the present invention, a detection system based on a plate agglutination test is provided, such as... Figure 6 and Figure 7 As shown, the detection system includes several detection units, each of which includes:

[0057] Aggregation plate 10, which has a carrier for holding the sample to be tested and antibody reagent, said carrier is a transparent structure;

[0058] An uncovered detection grid 20 is disposed below the agglomeration plate 10, forming a detection cavity between the detection grid 20 and the agglomeration plate 10, and the detection grid 20 is a non-transparent structure;

[0059] A light source 30 for illumination is disposed inside the detection cavity;

[0060] A light intensity sensor 40 is disposed inside the detection cavity;

[0061] A processor, electrically connected to the light intensity sensor 40, is configured to determine the agglutination result of the sample to be tested and the antibody reagent based on the light intensity detected by the light intensity sensor 40.

[0062] like Figure 6 As shown, there are multiple detection units arranged in a matrix, and the processors of these multiple detection units can be integrated into a single processing module. Figure 6As shown, the detection system also includes a support base 50 and a cover plate 60. The support base 50 is used to support the detection grids 20 of each detection unit. The agglomeration plate 10 is placed on the detection grids 20. In this embodiment, the agglomeration plates 10 of multiple detection units are integrated into a single glass slide. The detection system is equipped with one or more glass slides of the same specifications, meaning the glass slides can be used as disposable consumables. In this embodiment, both the cover plate and the agglomeration plate 10 can be transparent. The cover plate can be a flat glass plate, which is positioned above the agglomeration plate 10.

[0063] like Figure 7 As shown, the support portion of the agglomeration plate 10 has a concave structure. Furthermore, the center of the concave structure of the support portion is preferably positioned opposite to the receiving end of the light intensity sensor 40.

[0064] like Figure 6 and Figure 7 As shown, the optical axis of the light source 30 points to the center of the recessed structure of the support portion; the present invention does not limit the light source 30 to be a point light source or a line light source. In another embodiment of the present invention, the light source 30 is an annular light source, and the projection of the center of the recessed structure of the support portion onto the plane of the annular light source is located at the center of the annular light source.

[0065] The reaction well positions of each detection unit are determined by the concave structure of the support section. First, the positions where samples and antibody reagents are dropped onto each agglutination plate 10 can be clearly defined. Second, the flow range of samples and antibody reagents can be constrained to avoid mixing with samples / antibody reagents on adjacent agglutination plates.

[0066] Correspondingly, the detection system also includes an automatic sample dispensing mechanism, which is equipped with a single sample dispensing head arranged in a row or matrix, and a driving device for moving the sample dispensing heads. For example, the detection unit is in the form of an 8×10 matrix, with eight sample dispensing heads in a row. Each time, the test liquid can be dispensed onto eight agglomeration plates in a row simultaneously, improving the sample dispensing efficiency and increasing the detection throughput.

[0067] The detection principle of the detection system in this embodiment of the invention is as follows: Figure 7As shown, light source 30 provides illumination to the opaque detection chamber. After the quantitative sample and quantitative antibody reagent are mixed by flowing in the reaction well, the LED light source is activated. The LED output light is incident on the bottom of the reaction well. Because the agglutination plate is made of a high-transmittance material, part of the incident light is diffusely reflected due to the blockage of the sample and antibody reagent mixture and is received by the light intensity sensor to detect the light intensity value at the current moment. The other part of the incident light passes through the agglutination plate and the sample and antibody reagent mixture and becomes transmitted light. This application utilizes the fact that different degrees of agglutination affect the transmittance and reflectance of the illumination light on the lower surface of the agglutination plate: after the test sample and antibody reagent are fluorescently stained and dropped onto the agglutination plate, the weaker the agglutination or even the absence of agglutination, the less transparent part there is in the sample and antibody mixture, and more of the incident light intensity is reflected to the light intensity sensor. The stronger the reflected light collected by the light intensity sensor, the higher the reading of the light intensity sensor. If the test sample and antibody reagent do not undergo an agglutination reaction (the sample is negative), compared to Figures 2 to 5 state, Figure 1 The agglutination plate shown has a stronger light-blocking rate, resulting in lower transmittance and higher reflectance of the illumination light on its lower surface. Therefore, the light intensity after a period of time will not change significantly compared to the initial light intensity at the beginning of mixing. Conversely, the stronger the agglutination, the more transparent the mixture of sample and antibody, and the more incident light is emitted as transmitted light, resulting in weaker emitted light collected by the light intensity sensor and lower sensor readings. If the sample to be tested undergoes an agglutination reaction with the antibody reagent (sample positive), Figure 5 For example, the agglomerates in the droplets resemble bacterial clusters, with large agglomerates or small granules appearing. The droplets between the agglomerates are completely transparent, resulting in a relatively low light-blocking rate for the agglomerated plates. Figure 1 The light intensity is smaller, so the transmittance of the illumination light on the lower surface of the agglomeration plate is greater and the reflectance is lower. Therefore, the light intensity will decrease significantly before and after the agglomeration reaction.

[0068] There are many ways to determine whether a sample to be tested agglutinates with antibody reagents:

[0069] First embodiment: The light intensity sensor is configured to detect light intensity after a preset time interval to obtain the current light intensity value; based on a preset light intensity threshold range corresponding to the degree of agglutination, the processor determines the light intensity threshold range in which the current light intensity value falls, thereby determining the degree of agglutination between the sample to be tested and the antibody reagent; the appropriate light intensity threshold range corresponding to each degree of agglutination can be determined experimentally: Figures 1 to 5 The corresponding agglomeration plates are placed on the detection grid. Under the same environment, the same power light source is turned on, and the same type of light intensity sensor is used to detect the light intensity values ​​under five conditions, thereby determining the light intensity threshold range corresponding to the five agglomeration degrees.

[0070] Second embodiment: The light intensity sensor is configured to detect the light intensity in the initial state after the sample to be tested and the antibody reagent are mixed, and obtain an initial light intensity value; and to detect the light intensity after a preset reaction time, and obtain a termination light intensity value; the processor compares the initial light intensity value and the termination light intensity value, and then determines the degree of agglomeration of the sample to be tested and the antibody reagent; specifically, for example, if the decrease in the termination light intensity value compared with the initial light intensity value reaches a certain light intensity difference threshold, it is determined that the sample to be tested and the antibody reagent have agglomerated.

[0071] Third embodiment: A light intensity sensor is configured to perform real-time light intensity detection on the state of the sample to be tested after mixing with the antibody reagent, obtaining a real-time light intensity value; the processor determines a light intensity change curve based on the real-time light intensity value, and then determines the degree and progress history of agglomeration of the sample to be tested and the antibody reagent based on one or more of the shape, rate of decrease, and inflection point of the light intensity change curve; the excitation light source LED, in conjunction with the light intensity sensor, collects reflected light approximately every 330 milliseconds, forming a discrete set of values ​​that reflects the agglomeration state of the reaction pores. The system analyzes, calculates, and summarizes this set of values, outputting the agglomeration reaction results and a characteristic description of the entire agglomeration process: such as Figure 9 As shown, the horizontal axis represents the number of tests, with a test time interval of approximately 330 milliseconds between the two sides. The vertical axis represents the light intensity value. It can be seen that within the timeframe sufficient for agglutination to occur, the detected light intensity value remained roughly the same, without a significant decrease. Therefore, it can be determined that the sample and antibody reagent did not agglutinate. Figure 10 As shown, the horizontal axis represents the number of tests, with a time interval of approximately 330 milliseconds between tests on both sides. The vertical axis represents the light intensity value. It is evident that the light intensity value begins to decrease slightly around the 300th test, and then drops sharply between the 400th and 700th tests. This confirms that the sample agglutinated with the antibody reagent. Furthermore, the light intensity change curve shows the occurrence and duration of the light intensity decrease. Horizontal comparison, i.e., comparing the light intensity change curves corresponding to multiple agglutination plates, allows identification of the bacterial concentration in the sample through the curve's shape. Specifically, an earlier inflection point or a steeper slope indicates a higher bacterial concentration in the sample. In this embodiment, the detection system based on the plate agglutination test also includes a display electrically connected to the processor, configured to display the agglutination results corresponding to each detection unit.

[0072] Machine vision-based agglutination result determination can only output a qualitative result, such as negative (no agglutination) or positive (strong agglutination), but it cannot describe the entire agglutination reaction process over 4-5 minutes. It cannot form an analyzable and evaluable digital description of the complete agglutination reaction process, and therefore cannot obtain the characteristics of this agglutination reaction. For example, some agglutination reactions are very intense and rapid, forming strong agglutination within 30-40 seconds; while other reactions are mild and slow, with no obvious agglutination phenomenon in the first 4 and a half minutes, and only forming weak agglutination in the last 30 seconds. However, the third embodiment of the present invention can analyze the characteristics of the agglutination reaction. Through the analysis of the characteristics of the agglutination process, the concentration of pathogenic microorganisms contained in the sample can be further evaluated, and it is also of great significance for the evaluation of antibody titers. It may even have the significance of transforming qualitative detection into quantitative and semi-quantitative detection.

[0073] like Figure 8 As shown, the present invention provides a method for detecting plate agglomeration, comprising the following steps:

[0074] An opaque detection chamber is set below the transparent agglomeration plate, and a light source and a light intensity sensor are set inside the detection chamber;

[0075] The sample to be tested and the antibody reagent are added to the agglutination plate and mixed. Specifically, there are multiple agglutination plates and detection chambers, and they correspond one-to-one. The sample to be tested and the antibody reagent are added to each agglutination plate, and the two are added at different positions. After all agglutination plates have completed the addition operation, all agglutination plates are moved or rotated synchronously, so that the sample to be tested and the antibody reagent flow on the agglutination plate.

[0076] Turn on the light source and use a light intensity sensor to detect the light intensity information;

[0077] The agglutination result of the sample to be tested and the antibody reagent is determined based on the light intensity detected by the light intensity sensor.

[0078] As described in the embodiment of the detection system, the agglutination result of the sample to be tested and the antibody reagent is determined by any of the following methods:

[0079] Method 1 involves configuring the light intensity sensor to detect light intensity after a preset time interval to obtain the current light intensity value; determining the light intensity threshold range in which the current light intensity value falls based on a preset light intensity threshold range corresponding to the degree of agglutination, thereby determining the degree of agglutination between the sample to be tested and the antibody reagent;

[0080] Method 2 involves configuring the light intensity sensor to detect the light intensity in the initial state after the sample to be tested and the antibody reagent are mixed, obtaining an initial light intensity value; and to detect the light intensity after a preset reaction time, obtaining a termination light intensity value; and to compare the initial light intensity value and the termination light intensity value to determine the degree of agglomeration of the sample to be tested and the antibody reagent.

[0081] Method 3 involves configuring the light intensity sensor to perform real-time light intensity detection on the state of the sample to be tested after mixing with the antibody reagent, and obtaining a real-time light intensity value; determining a light intensity change curve based on the real-time light intensity value, and then determining the degree and progress history of agglutination of the sample to be tested and the antibody reagent based on one or more of the shape, rate of decrease, and inflection point of the light intensity change curve.

[0082] The plate agglomeration detection method provided in this embodiment belongs to the same inventive concept as the detection system provided in the above embodiment. Here, all contents of the detection system embodiment are incorporated into this plate agglomeration detection method embodiment by reference, and will not be repeated.

[0083] In summary, this invention aims to provide a method for detecting and determining the agglomeration reaction of a plate. By placing a light intensity sensor detection module below each agglomeration reaction well, the light intensity of the reaction well can be detected in real time and continuously, forming a light intensity data set. By analyzing and calculating this data set, the determination result of the agglomeration reaction and the characteristic description of the entire agglomeration reaction process are output, thereby solving the shortcomings of the prior art, such as high hardware and software costs, large / complex / unreliable instrument system, and only simple qualitative judgment results.

[0084] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0085] The above description is only a specific embodiment of this application. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of this application, and these improvements and modifications should also be considered within the scope of protection of this application.

Claims

1. A detection system based on a plate agglutination test, characterized in that, It includes several detection units, each of which includes: Agglutination plate having a carrier for holding the sample to be tested and antibody reagents, said carrier being a transparent structure; An uncovered detection grid is disposed below the agglomeration plate, forming a detection cavity between the detection grid and the agglomeration plate, and the detection grid is a non-transparent structure; A light source for illumination is disposed within the detection cavity; A light intensity sensor is disposed inside the detection cavity; A processor, electrically connected to the light intensity sensor, is configured to determine the agglutination result of the sample to be tested and the antibody reagent based on the light intensity detected by the light intensity sensor.

2. The detection system based on the plate agglutination test according to claim 1, characterized in that, The support portion of the agglomeration plate has a concave structure.

3. The detection system based on the plate agglutination test according to claim 2, characterized in that, The center of the recessed structure of the support part is positioned opposite to the receiving end of the light intensity sensor; And / or, the optical axis of the light source points to the center of the recessed structure of the support portion; And / or, the light source is a ring-shaped light source.

4. The detection system based on the plate agglutination test according to claim 1, characterized in that, It also includes a support for supporting the test cells of each test unit, and the agglomeration plate is placed on the test cells.

5. The detection system based on the plate agglutination test according to claim 4, characterized in that, The detection system also includes a cover plate disposed above the agglomeration plate.

6. The detection system based on the plate agglutination test according to claim 1, characterized in that, The agglomeration plates of multiple detection units are integrated into a single glass slide, and the detection system is equipped with one or more glass slides of the same specifications.

7. The detection system based on the plate agglutination test according to claim 1, characterized in that, The number of detection units is multiple, and they are arranged in a matrix. The detection system also includes an automatic sample dispensing mechanism, which is equipped with one or a row or matrix of sample dispensing heads and a drive device for moving the sample dispensing heads.

8. The detection system based on the plate agglutination test according to any one of claims 1 to 7, characterized in that, The agglutination result of the test sample and the antibody reagent shall be determined by any of the following methods: Method 1 involves configuring the light intensity sensor to detect light intensity after a preset time interval to obtain the current light intensity value; based on a preset light intensity threshold range corresponding to the degree of agglutination, the processor determines the light intensity threshold range in which the current light intensity value falls, thereby determining the degree of agglutination between the sample to be tested and the antibody reagent; Method 2 involves configuring the light intensity sensor to detect the light intensity in the initial state after the sample to be tested and the antibody reagent are mixed, obtaining an initial light intensity value; and to detect the light intensity after a preset reaction time, obtaining a termination light intensity value; the processor compares the initial light intensity value and the termination light intensity value to determine the degree of agglomeration of the sample to be tested and the antibody reagent. Method 3 involves configuring the light intensity sensor to perform real-time light intensity detection on the state of the sample to be tested after mixing with the antibody reagent, and obtaining a real-time light intensity value; the processor determines a light intensity change curve based on the real-time light intensity value, and then determines the degree and progress history of agglutination of the sample to be tested and the antibody reagent based on one or more of the shape, rate of decrease, and inflection point of the light intensity change curve.

9. The detection system based on the plate agglutination test according to claim 8, characterized in that, It also includes a display electrically connected to the processor, which is configured to display the agglomeration results corresponding to each detection unit.

10. A method for detecting plate agglomeration, characterized in that, Includes the following steps: An opaque detection chamber is set below the transparent agglomeration plate, and a light source and a light intensity sensor are set inside the detection chamber; Add the sample to be tested and antibody reagent to the agglutination plate and mix them; Turn on the light source and use a light intensity sensor to detect the light intensity information; The agglutination result of the sample to be tested and the antibody reagent is determined based on the light intensity detected by the light intensity sensor.

11. The method for detecting plate agglomeration according to claim 10, characterized in that, The agglomeration plates and detection chambers are multiple and correspond one-to-one; Add the sample to be tested and the antibody reagent to each agglutination plate, with the two added at separate points; After all agglutination plates have been added, all agglutination plates are moved or rotated synchronously, so that the sample to be tested and the antibody reagent flow on the agglutination plates.

12. The plate agglomeration detection method according to claim 10, characterized in that, The agglutination result of the test sample and the antibody reagent shall be determined by any of the following methods: Method 1 involves configuring the light intensity sensor to detect light intensity after a preset time interval to obtain the current light intensity value; determining the light intensity threshold range in which the current light intensity value falls based on a preset light intensity threshold range corresponding to the degree of agglutination, thereby determining the degree of agglutination between the sample to be tested and the antibody reagent; Method 2 involves configuring the light intensity sensor to detect the light intensity in the initial state after the sample to be tested and the antibody reagent are mixed, thereby obtaining an initial light intensity value; and to detect the light intensity after a preset reaction time, thereby obtaining a termination light intensity value. By comparing the initial light intensity value and the final light intensity value, the degree of agglutination between the sample to be tested and the antibody reagent is determined. Method 3 involves configuring the light intensity sensor to perform real-time light intensity detection on the state of the sample to be tested after it is mixed with the antibody reagent, and obtaining a real-time light intensity value. The light intensity change curve is determined based on the real-time light intensity value, and then the degree and progress history of agglutination between the sample to be tested and the antibody reagent are determined based on one or more of the shape, rate of decrease, and inflection point of the light intensity change curve.