Formation of components with immunoassay devices and methods

Abstract

In the formed element and immunoassay detection apparatus and method, a camera module is used to capture images of the formed element sample containing cavity and transmit the images to the formed element detection and analysis module. The formed element detection and analysis module analyzes the images to obtain the detection information of the formed element sample. Similarly, a camera module is used to capture images of the immunoassay sample containing cavity and transmit the images to the immunoassay analysis module. The immunoassay analysis module analyzes the images to obtain the detection information of the immunoassay sample. Process A: Capture a microscopic image of the formed element sample; AI identifies the formed elements in the microscopic image, calculates the content of formed elements in the sample, and outputs a formed element detection report. Process B: Capture a microscopic image of the immunoassay sample; AI identifies aggregated microparticles in the microscopic image, calculates the content of immunocomponents in the sample, and outputs an immunocomponent detection report.

Description

Technical Field

[0001] This application belongs to the field of formed element and immunoassay technology based on magnified microscopic images, and particularly relates to the analysis of formed elements such as cells and immunoassay, especially to methods and apparatus that can simultaneously realize the detection of formed elements and immunoassay. Background Technology

[0002] The applicant has pioneered a method and device for the analysis of formed elements in the industry. By adding a suspension to a detection chip, the formed elements in the suspension are directly imaged under a microscope, and the formed elements are detected and analyzed based on the microscopic images.

[0003] Immunological testing includes a variety of tests, mainly involving the examination of humoral immunity and cellular immunity.

[0004] Humoral immunity testing mainly includes immunoglobulins, complement, and autoantibodies. Immunoglobulin testing includes IgG, IgA, and IgM, etc., and increases or decreases in these immunoglobulins may reflect different disease states. Complement testing includes CH50, C3, C4, etc., and abnormal complement levels may also be associated with certain diseases. Autoantibody testing includes antinuclear antibodies, anti-double-stranded DNA antibodies, and anti-extractable nuclear antigen (ENA) antibodies, etc. The presence of these autoantibodies may be related to autoimmune diseases.

[0005] Cellular immunity testing mainly includes the detection of T lymphocyte subsets, B lymphocyte subsets, and NK cell activity. The detection of T lymphocyte subsets can reflect the state of the body's cellular immune function, the detection of B lymphocyte subsets can reflect the state of humoral immune function, and the detection of NK cell activity can reflect the body's ability to kill tumor cells.

[0006] Currently available methodologies for detecting immunological parameters include enzyme-linked immunosorbent assay (ELISA), colloidal gold immunochromatography, fluorescence immunochromatography, immunoturbidimetry, and chemiluminescence immunoassay.

[0007] Medical testing analytical devices include a variety of instruments, which can be classified in various ways according to their function or detection principle, such as:

[0008] Type A: Detection devices based on the optical properties of visible light, such as biochemical analyzers and enzyme-linked immunosorbent assay (ELISA) analyzers. These devices detect light energy based on the transmission, scattering, or absorption characteristics of different substances in a sample, thereby obtaining information about the composition or content of the corresponding components. For example, a fully automated chemiluminescence immunoassay analyzer uses chemiluminescence technology to automate sample processing and detection, and is suitable for analyzing blood immune indicators.

[0009] Type B: Detection devices based on fluorescence properties, including immunofluorescence immunoassay devices. These instruments have complex principles, including radioimmunoassay, immunofluorescence assay, and chemiluminescence immunoassay. They utilize excitation light of a specific wavelength to excite fluorescent substances, causing them to emit fluorescence of a specific wavelength for detection. They also utilize fluorescent dyes and light sources to detect antibodies or antigens, exhibiting high sensitivity and specificity, suitable for pathological diagnosis and research on autoimmune diseases. Finally, they use luciferase as a label, binding to antigen-antibody reactions, for the detection of specific biomarkers.

[0010] Type C: Chemiluminescence-based detection devices utilize special chemiluminescent substances that emit light of a specific wavelength under specific conditions for detection. Chemiluminescence is usually combined with enzyme-catalyzed and magnetic microparticle-based methods to label immune antibodies onto magnetic beads, enzymes, and luminescent signal substances. Through a series of reactions, analytes with specific targets can be measured.

[0011] Type D: Microscopic magnification-based formed element analysis devices. Examples include blood analyzers that detect white blood cells and red blood cells, and urine analyzers that detect crystalline components in urine.

[0012] Traditional immunoassay devices typically rely on optical or other features observed during complex immune reactions. These devices are designed specifically for different target measurements and are therefore dedicated to their own purposes. They cannot share key components with other devices, resulting in each device bearing its own hardware cost and a high cost per unit.

[0013] Existing technologies also include multi-functional integrated machines that can perform multiple tests such as immunology, complete blood count, and coagulation, making them suitable for large medical institutions. However, these machines directly combine different testing devices based on different principles into a larger cabinet, achieving a workstation-style integration. The different tests are not unified at the underlying level of the original testing components, resulting in higher hardware costs, making them less economical and space-consuming.

[0014] How to maximize the sharing of hardware platforms based on existing formed element instruments, so that a single device can perform both formed element detection and immunoassay, is a technical problem to be solved. Summary of the Invention

[0015] The applicant has developed a formed element analyzer based on microscopic images of suspension samples, which expands the functionality of the same hardware platform to further realize immunoassay based on microscopic images of suspension samples, achieving the fusion of formed element and immunoassay detection, and minimizing hardware implementation costs.

[0016] The technical solution of this application to solve the above-mentioned technical problems is a formed element and immunoassay detection device, including a detection control component, a camera component, a sample carrier component, and a carrier component; the detection control component and the camera component are signal connected; the detection control component and the carrier component are signal connected; the carrier component is used to carry the sample carrier component; the detection control component includes a formed element detection and analysis module and an immunoassay analysis module; the sample carrier component includes a formed element sample receiving cavity and / or an immunoassay sample receiving cavity; the camera component includes a camera module; the camera module is used to capture images inside the formed element sample receiving cavity and transmit the images to the formed element detection and analysis module, which analyzes the images to obtain the detection information of the formed element sample; the camera module is used to capture images inside the immunoassay sample receiving cavity and transmit the images to the immunoassay analysis module, which analyzes the images to obtain the detection information of the immunoassay sample.

[0017] Alternatively, the detection and control component may include a focus control module, and the camera component may include a focus adjustment component; the focus control module analyzes the image to obtain image focus quality information, and sends focus control information to the focus adjustment component, which then adjusts the focus according to the focus control information.

[0018] Yes, it can also include AI components, which include AI computing modules and are connected to the detection and control components via signals.

[0019] The AI ​​components mentioned above may include a formed element AI feature dataset and an aggregated microparticle immune detection sample AI feature dataset. The AI ​​computing module, in conjunction with the formed element AI feature dataset, can identify cells; and the aggregated microparticle immune detection sample AI feature dataset, in conjunction with the AI ​​computing module, can identify aggregated microparticles.

[0020] Alternatively, the sample carrying assembly may include a sample containing device A, which includes a cavity for containing formed sample; or the sample carrying assembly may include a sample containing device B, which includes a cavity for containing immunoassay sample.

[0021] It is possible that the sample carrying component includes a sample containing device C, wherein the sample containing device C includes a constituent sample containing cavity and an immunoassay sample containing cavity.

[0022] Alternatively, the sample carrying component may include a sample containing device D, which includes a sample containing cavity for containing formed element samples or immunoassay samples.

[0023] It is possible that the aforementioned carrier component includes an XY movement component, which is capable of carrying the detection sample carrier component to move in the X-axis direction or the Y-axis direction on a horizontal plane.

[0024] Alternatively, the aforementioned AI components can be deployed on an AI cloud server, which then connects to the detection and control components via a network.

[0025] Alternatively, the aforementioned detection and control components may be deployed on a general-purpose computer, and the detection and control components may be connected to the camera components or carrier components via wired or wireless signals.

[0026] The technical solution of this application to solve the above-mentioned technical problems can also be a formed element and immunoassay method, including process A: taking a microscopic image of the formed element test sample, AI identifying the formed elements in the microscopic image, calculating the content of formed elements in the test sample, and outputting a formed element test report; process B: taking a microscopic image of the immunoassay sample, AI identifying the aggregated microparticles in the microscopic image, calculating the content of immunoassay components in the test sample, and outputting an immunoassay component test report.

[0027] It is possible that the formed element detection sample and the immune detection sample are located in different sample containing cavities.

[0028] It is possible that the formed element detection sample and the immune detection sample mentioned above are the same sample, located in the same sample containing cavity, and the microscopic images of process A and process B mentioned above are the same microscopic image.

[0029] It is possible that the formed element detection sample and the immune detection sample are from the same source, but are placed into different sample containing cavities.

[0030] Yes, the formed element test report and the immune component test report can be combined into one report.

[0031] Yes, the formed element test samples mentioned above can be blood, urine, or feces test samples, and the immune test samples mentioned above can be blood, urine, or feces test samples.

[0032] One of the technical benefits of the above-mentioned technical solution is the inclusion of a component detection and analysis module and an immune detection and analysis module, which allows two different types of detection projects to share the same underlying hardware, namely the detection control component, camera component, and sample carrier component. This reduces the overall cost of the equipment and represents a significant advancement in the application.

[0033] One of the technical effects of the above-mentioned technical solution is that the setting of the focus control module and the focus adjustment component can obtain clear magnified microscopic images.

[0034] One of the technical effects of the above-mentioned technical solution is that the AI ​​component improves detection efficiency, making it possible to output reports based on microscopic images.

[0035] One of the technical effects of the above-mentioned technical solution is the creation of AI feature datasets for formed components and AI feature datasets for immunoassay samples of aggregated microparticles, enabling the device and method to have AI recognition capabilities for two different types of items.

[0036] One of the technical advantages of the above-mentioned technical solution is that it can accommodate both the sample-forming chamber and the immunoassay sample-forming chamber, each of which can independently accommodate more testing items.

[0037] One of the technical advantages of the above-mentioned technical solution is that the sample container C includes a formed sample container cavity and an immunoassay sample container cavity, which is suitable for routine tests that do not interfere with each other, thereby reducing testing costs.

[0038] One of the technical effects of the above-mentioned technical solution is that the XY moving component can carry the test sample carrier component to move in the X-axis direction or the Y-axis direction on the horizontal plane, which facilitates large-area microscopic imaging.

[0039] One of the technical benefits of the above-mentioned technical solution is that deploying AI components on an AI cloud server can provide sufficient computing power.

[0040] One of the technical effects of the above-mentioned technical solution is that the detection and control component is deployed on a general-purpose computer, and the detection and control component is connected to the camera component or the carrier component via wired or wireless signal, which can further improve the versatility of the equipment and reduce the application cost for the client.

[0041] One of the technical advantages of the above-mentioned technical solution is that processes A and B can run in parallel, resulting in higher efficiency.

[0042] One of the technical effects of the above technical solution is that processes A and B are performed separately and independently, which can adapt to different demand scenarios.

[0043] One of the technical benefits of the above-mentioned technical solution is that it combines the formed component detection report and the immune component detection report into a single report, thereby reducing costs and increasing the density of output information.

[0044] One of the technical advantages of the above-mentioned technical solution is that the formed element detection sample can be blood, urine or feces, and it can be applied to a variety of samples. It is an efficient, comprehensive device and method applicable to multiple scenarios. Attached Figure Description

[0045] Figure 1 This is a schematic block diagram of a device for detecting formed elements and immune responses;

[0046] Figure 2 This is a schematic block diagram of a device for detecting formed elements and immune responses;

[0047] Figure 3 This is a schematic block diagram of a device for detecting formed elements and immune responses;

[0048] Figure 4 This is a schematic block diagram of a device for detecting formed elements and immune responses;

[0049] Figure 5 This is a schematic block diagram of a device for detecting formed elements and immune responses;

[0050] Figure 6 This is a schematic block diagram of a device for detecting formed elements and immune responses;

[0051] Figure 7 This is a schematic diagram of the detection of formed elements, aggregated particles, and particles within the cavity;

[0052] Figure 8 This is a schematic diagram of the sample carrier component.

[0053] Figure 9 This is a flowchart illustrating the detection methods for formed elements and immunoassays.

[0054] Figure 10 This is a flowchart illustrating the detection methods for formed elements and immunoassays.

[0055] Figure 11 This is a schematic diagram of the sample carrier component.

[0056] Figure 12 This is a schematic diagram of the sample carrier component. Detailed Implementation

[0057] The contents of this application will be further described in detail below with reference to the accompanying drawings. It should be noted that the following description is of preferred embodiments of the present invention and does not constitute any limitation on the present invention. The description of the preferred embodiments of the present invention is merely an explanation of the general principles of the invention. The designations "first," "second," "A," and "B" used in this invention are for ease of explanation only and do not represent a temporal or spatial order. The combinations of letters and numbers "S," "M," and "H" used in this invention are for ease of explanation only, and their specific meanings are determined by the specific terms they represent.

[0058] like Figure 1An embodiment of a formed element and immunoassay detection device includes a detection control component, a camera component, a sample carrier component, and a carrier component. The detection control component and the camera component are signal-connected; the detection control component and the carrier component are also signal-connected; the carrier component carries the sample carrier component; the detection control component includes a formed element detection and analysis module and an immunoassay analysis module; the sample carrier component includes a formed element sample receiving cavity and / or an immunoassay sample receiving cavity; the camera component includes a camera module; the camera module is used to capture images within the formed element sample receiving cavity and transmit the images to the formed element detection and analysis module, which analyzes the images to obtain detection information for the formed element sample; the camera module is also used to capture images within the immunoassay sample receiving cavity and transmit the images to the immunoassay analysis module, which analyzes the images to obtain detection information for the immunoassay sample. The images in this application are magnified microscopic images. A magnifying microscope is provided in front of the camera component. The obtained images are magnified microscopic images.

[0059] like Figure 2 An embodiment of a formed element and immune detection device, wherein the detection control component includes a focus control module and the imaging component includes a focus adjustment component; the focus control module analyzes the image to obtain image focus quality information, and sends focus control information to the focus adjustment component, which then adjusts the focus according to the focus control information.

[0060] like Figure 3 One embodiment of a formed element and immune detection device further includes an AI component, which includes an AI computing module and is signal-connected to a detection control component.

[0061] like Figure 4 An embodiment of a formed element and immune detection device, wherein the AI ​​component includes a formed element AI feature dataset and an aggregated microparticle immune detection sample AI feature dataset, wherein the AI ​​computing module, in conjunction with the formed element AI feature dataset, is capable of identifying cells; and the aggregated microparticle immune detection sample AI feature dataset, wherein the AI ​​computing module, in conjunction with the aggregated microparticle immune detection sample AI feature dataset, is capable of identifying aggregated microparticles.

[0062] In this application, the formed component AI feature dataset is feature data obtained after training an AI computing model, and this feature data, in conjunction with the aforementioned AI computing model, can perform AI calculations. Alternatively, the formed component AI feature dataset is an AI computing model obtained after training an AI computing model, and this AI computing model can perform AI calculations.

[0063] In this application, the AI ​​feature dataset for aggregated microparticle immune detection samples is feature data obtained after training an AI computational model. This feature data, in conjunction with the aforementioned AI computational model, can perform AI calculations. Alternatively, the AI ​​feature dataset for aggregated microparticle immune detection samples is an AI computational model obtained after training an AI computational model, and this AI computational model can perform AI calculations.

[0064] like Figure 4 An embodiment of a formed element and immunoassay detection device includes a sample carrying assembly comprising a sample receiving device A, wherein the sample receiving device A includes a formed element sample receiving cavity; and a sample carrying assembly comprising a sample receiving device B, wherein the sample receiving device B includes an immunoassay sample receiving cavity.

[0065] like Figure 8 A sample container for actual testing was demonstrated.

[0066] like Figure 11 A practical sample container for testing is demonstrated, featuring four chambers, A1 to A4. Chambers A1, A2, A3, and A4 can each be used for a single formed element test. Alternatively, chambers A1, A2, A3, and A4 can each be used for a single immunoassay test. Another option is to use chambers A1, A2, A3, and A4 in combination for both immunoassay and formed element testing.

[0067] like Figure 12 yes Figure 11 The bottom surface of the cavity, chambers A1, A2, A3, and A4 (each chamber) are equipped with corresponding sample addition ports and exhaust ports, facilitating the independent addition of samples.

[0068] like Figure 5 An embodiment of a formed element and immunoassay detection device includes a sample carrying component comprising a sample receiving device C, wherein the sample receiving device C comprises a formed element sample receiving cavity and an immunoassay sample receiving cavity.

[0069] In some embodiments, the sample carrying assembly includes a sample receiving device D, which includes a sample receiving cavity for receiving formed element samples or immunoassay samples.

[0070] like Figure 4 and Figure 5 An embodiment of a formed element and immune detection device, wherein the carrier component includes an XY moving component, which is capable of carrying the detection sample carrier component to move in the X-axis direction or the Y-axis direction on a horizontal plane.

[0071] like Figure 6 In one embodiment of a formed element and immune detection device, the AI ​​component is arranged on an AI cloud server, and the AI ​​cloud server is connected to the detection control component via a network.

[0072] In some embodiments, the detection control component described above is deployed on a general-purpose computer, and the detection control component is connected to the camera component or the carrier component via wired or wireless means.

[0073] like Figure 9 and Figure 10 An embodiment of a method for detecting formed elements and immunoassay includes: Process A: capturing a microscopic image of the formed element detection sample, using AI to identify the formed elements in the microscopic image, calculating the content of formed elements in the sample, and outputting a formed element detection report; Process B: capturing a microscopic image of the immunoassay sample, using AI to identify aggregated microparticles in the microscopic image, calculating the content of immunocomponents in the sample, and outputting an immunocomponent detection report. Processes A and B are performed in parallel, without any order. Alternatively, one process can be executed first, followed by the other.

[0074] like Figure 7 The diagram shows a portion of the formed elements and aggregated particles. It is a schematic representation of the stable state of a fecal suspension, including microparticles, aggregated particles, red blood cells, and white blood cells.

[0075] The formed elements in this application include, but are not limited to:

[0076] Blood: white blood cells, red blood cells, platelets, blood parasites.

[0077] Urine: casts, crystals, bacteria, cells, fungi.

[0078] Feces: cells, bacteria, fungi, insect eggs, protozoa.

[0079] The immunoassay items in this application include, but are not limited to:

[0080] Inflammation: Canine CRP, Feline SAA.

[0081] Myocardium: canine / cat cTnI, NT-proBNP.

[0082] Infectious diseases: canine distemper, canine parvovirus, canine infectious hepatitis, feline panleukopenia, etc.

[0083] Tumors: PSA, CEA, etc.

[0084] like Figures 1 to 4 The formed element detection samples and the immune detection samples are located in different sample containing cavities.

[0085] In some embodiments, the formed element detection sample and the immune detection sample are samples from the same source, and are respectively added to different sample containing cavities.

[0086] like Figure 5 The formed element detection sample and the immune detection sample mentioned above are the same sample, located in the same sample containing cavity, and the microscopic images of process A and process B mentioned above are the same microscopic image.

[0087] like Figure 10 In some embodiments, the formed component detection report and the immune component detection report are combined into a single report for output.

[0088] In some embodiments, the formed element detection sample is a blood, urine, or feces detection sample, and the immune detection sample is a blood, urine, or feces detection sample.

[0089] While the present invention has been described and illustrated with reference to preferred embodiments and several alternatives, the invention is not limited to the specific descriptions herein. Other alternatives or equivalent components may also be used to practice the invention.

Claims

1. A device for detecting formed elements and immunoassays, characterized in that, Includes detection control components, camera components, sample carrier components, and carrier components; The detection control component and the camera component are connected by signals; The detection and control components are connected to the carrier components via signal connections; The carrier component is used to support the test sample carrier component; The detection control component includes a formed element detection and analysis module and an immunoassay analysis module; the detection sample carrying component includes a formed element sample receiving cavity and / or an immunoassay sample receiving cavity; The camera assembly includes a camera module; The camera module is used to capture images of the cavity containing the formed element sample and transmit the images to the formed element detection and analysis module. The formed element detection and analysis module analyzes the images to obtain the detection information of the formed element sample. The camera module is used to capture images inside the cavity containing the immunoassay sample and transmit the images to the immunoassay analysis module. The immunoassay analysis module analyzes the images to obtain the detection information of the immunoassay sample.

2. The formed elements and immune detection device according to claim 1, characterized in that, The detection and control component includes a focus control module, and the camera component includes a focus adjustment component. The focus control module analyzes the image to obtain image focus quality information, and sends focus control information to the focus adjustment component, which then adjusts the focus according to the focus control information.

3. The formed elements and immune detection device according to claim 1, characterized in that, It also includes AI components, which include AI computing modules and are connected to the detection and control components via signals.

4. The formed elements and immune detection device according to claim 3, characterized in that, The AI ​​components include a formed element AI feature dataset and an aggregated microparticle immune detection sample AI feature dataset. The AI ​​computing module works in conjunction with the formed element AI feature dataset to identify cells. The aggregated microparticle immune detection sample AI feature dataset also works in conjunction with the AI ​​computing module to identify aggregated microparticles.

5. The formed elements and immune detection device according to claim 1, characterized in that, The sample carrying assembly includes a sample containing device A, which includes a formed sample containing cavity; the sample carrying assembly also includes a sample containing device B, which includes an immunoassay sample containing cavity.

6. The formed elements and immune detection device according to claim 1, characterized in that, The sample carrying assembly includes a sample containing device C, which includes a constituent sample containing cavity and an immunoassay sample containing cavity.

7. The formed elements and immune detection device according to claim 1, characterized in that, The sample carrier assembly includes a sample receiving device D, which includes a sample receiving cavity for receiving formed element samples or immunoassay samples.

8. The formed elements and immune detection device according to claim 1, characterized in that, The carrier component includes an XY movement component, which is capable of carrying the detection sample carrier component to move in the X-axis direction or the Y-axis direction on a horizontal plane.

9. The formed elements and immune detection device according to claim 1, characterized in that, The AI ​​components are deployed on an AI cloud server, which is connected to the detection and control components via a network.

10. The formed elements and immune detection device according to claim 1, characterized in that, The detection and control component is deployed on a general-purpose computer and is connected to the camera component or the carrier component via wired or wireless signal communication.

11. A method for detecting formed elements and immunoassays, characterized in that, include: Process A: Take a microscopic image of the formed element detection sample, AI identifies the formed elements in the microscopic image, calculates the content of formed elements in the detection sample, and outputs a formed element detection report; Process B: Capture a microscopic image of the immunoassay sample, use AI to identify aggregated microparticles in the microscopic image, calculate the content of immune components in the sample, and output an immunoassay report.

12. The method for detecting formed elements and immunoassays according to claim 11, characterized in that, The formed element detection sample and the immune detection sample are located in different sample containing cavities.

13. The method for detecting formed elements and immunoassays according to claim 11, characterized in that, The formed element detection sample and the immune detection sample are the same sample, located in the same sample containing cavity, and the microscopic images of process A and process B are the same microscopic image.

14. The method for detecting formed elements and immunoassays according to claim 11, characterized in that, The formed element detection sample and the immune detection sample are from the same source, and are respectively added into different sample containing cavities.

15. The method for detecting formed elements and immunoassays according to claim 11, characterized in that, The formed element detection report and the immune component detection report are combined into one report for output.

16. The method for detecting formed elements and immunoassays according to claim 11, characterized in that, The formed element test sample is a blood, urine, or fecal test sample, and the immune test sample is a blood, urine, or fecal test sample.

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