A detection component and sample analyzer

Abstract

This application discloses a detection component and a sample analyzer. The detection component includes a substrate layer and a detection layer. The detection layer is disposed on the substrate layer and has a plurality of microchannels forming detection channels. The detection layer has a first cross-section, and the substrate layer has a second cross-section. The first and second cross-sections are perpendicular to the stacking direction of the substrate layer and the detection layer, and the area of ​​the first cross-section is larger than the area of ​​the second cross-section. The detection component of this application has a simple structure, good process consistency, and can reduce the failure rate of sample detection.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a detection component and a sample analyzer. Background Technology

[0002] With the development of biomedical detection technology, image-based detection, as a label-free and non-invasive detection method, is widely used in fields such as cell counting and cell morphology analysis. In image-based detection, the detection component, as the platform for sample carrying and reaction, has a decisive impact on the accuracy of the detection results.

[0003] Current image-based detection modules primarily utilize capillary action to introduce samples into the detection area, followed by imaging and analysis of cells using microscopes or imaging equipment. The design and manufacturing processes for these detection modules are highly demanding.

[0004] In the existing technology, the detailed design of the upper and lower substrates of the detection component is insufficient, resulting in poor process consistency of the detection component and a high failure rate of sample detection. Utility Model Content

[0005] This application provides a detection component and a sample analyzer to solve the technical problems of poor process consistency of detection components and high failure rate of sample detection in the prior art.

[0006] To solve the above-mentioned technical problems, one technical solution adopted in this application is to provide a detection component, which includes a substrate layer and a detection layer. The detection layer is disposed on the substrate layer and has a plurality of microchannels forming a detection channel; wherein, the detection layer has a first cross-section and the substrate layer has a second cross-section, the first cross-section and the second cross-section are perpendicular to the stacking direction of the substrate layer and the detection layer, and the area of ​​the first cross-section is larger than the area of ​​the second cross-section.

[0007] Furthermore, the difference between the length of the first cross-section and the length of the second cross-section is d1, where 0 < d1 ≤ 0.5 mm; the difference between the width of the first cross-section and the width of the second cross-section is d2, where 0 < d2 ≤ 0.5 mm.

[0008] Furthermore, the detection layer includes a flow channel layer and a cover plate layer. The flow channel layer is located between the cover plate layer and the substrate layer, and the flow channel layer has several microchannels.

[0009] Furthermore, the flow channel layer is a pressure-sensitive adhesive layer.

[0010] Furthermore, the detection layer includes a cover plate layer, and several microchannels are disposed on the side of the cover plate layer that contacts the detection layer.

[0011] Furthermore, a positioning part is provided on the side of the cover plate layer away from the substrate layer, and the positioning part is configured to position the placement direction of the detection component.

[0012] Furthermore, a hand-held portion is provided on the side of the cover plate layer opposite to the substrate layer.

[0013] Furthermore, one side of the cover plate layer is provided with several protrusions or several grooves to form a hand grip.

[0014] Furthermore, an indicator is provided on the side of the cover plate layer away from the substrate layer, and the indicator is configured to indicate the insertion direction of the detection component.

[0015] To solve the above-mentioned technical problems, one technical solution adopted in this application is to provide a sample analyzer, which includes a detection component and a detection device according to any of the above embodiments, wherein the detection device is used to detect the detection component.

[0016] The beneficial effects of this application are as follows: Unlike existing technologies, the detection component of this application includes a substrate layer and a detection layer. The detection layer is disposed on the substrate layer and has a plurality of microchannels forming detection channels. The detection layer has a first cross-section, and the substrate layer has a second cross-section. The first and second cross-sections are perpendicular to the stacking direction of the substrate layer and the detection layer, and the area of ​​the first cross-section is larger than the area of ​​the second cross-section. In the detection component of this application, the area of ​​the detection layer is larger than the area of ​​the substrate layer. This reduces misalignment of the bonding between the upper and lower wafer sidewalls, simplifies the manufacturing process of the detection component, improves process consistency, and thus reduces the failure rate of sample detection. Attached Figure Description

[0017] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0018] Figure 1 This is a schematic diagram of the structure of an embodiment of a detection component provided in this application;

[0019] Figure 2 yes Figure 1 A side view of the detection component shown.

[0020] Figure 3 This is a side view of another embodiment of a detection component provided in this application;

[0021] Figure 4 This is a schematic diagram of an embodiment of a sample analyzer provided in this application. Detailed Implementation

[0022] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application will be described in detail below with reference to the accompanying drawings. It should be understood that the specific embodiments described herein are for illustrative purposes only and are not intended to limit the scope of this application. Furthermore, it should be noted that, for ease of description, only the parts relevant to this application are shown in the accompanying drawings, not the entire structure. Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without inventive effort are within the scope of protection of this application.

[0023] The terms "first," "second," etc., used in this application are used to distinguish different objects, not to describe a specific order. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion. For example, a process, method, system, product, or apparatus that includes a series of steps or units is not limited to the listed steps or units, but may optionally include steps or units not listed, or may optionally include other steps or units inherent to these processes, methods, products, or apparatuses.

[0024] In this document, the term "embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of this application. The appearance of this phrase in various places throughout the specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment mutually exclusive with other embodiments. It will be explicitly and implicitly understood by those skilled in the art that the embodiments described herein can be combined with other embodiments.

[0025] In the field of biomedical testing, image-based detection technology is widely used in scenarios such as cell counting and cell morphology analysis due to its intuitive and efficient characteristics. This technology typically relies on a detection component as a sample carrier and reaction platform, acquiring cell images through image acquisition devices for counting and analysis.

[0026] This application provides a detection component that, by optimizing the design details of the upper and lower substrates, reduces the design and manufacturing complexity of the detection component, improves the process consistency of the detection component, reduces consumable costs, and lowers the sample detection failure rate. The structure and related parameters of the detection component provided in this application will be described in detail below.

[0027] Please see Figure 1 and Figure 2 As shown, Figure 1 This is a schematic diagram of the structure of one embodiment of a detection component provided in this application. Figure 2 yes Figure 1The side view of the detection component shown is a schematic diagram. Specifically, the detection component 10 includes a substrate layer 11 and a detection layer 12 stacked sequentially.

[0028] The substrate layer 11 of the detection component 10 is the foundation of the entire structure of the detection component 10, providing support for the detection layer 12. The design and material selection of the substrate layer 11 have a significant impact on the performance of the detection component 10, including cell distribution, hydrodynamic characteristics, and overall structural stability. The thickness and strength of the substrate layer 11 should be sufficient to support the detection layer 12 while maintaining the integrity of the structure during operation.

[0029] The substrate layer 11 can be made of plastics with good chemical stability, biocompatibility, and optical transparency, such as polypropylene, polyethylene, or polymethyl methacrylate. These materials can withstand the chemical and physical conditions encountered in routine biomedical testing processes. In other embodiments, the substrate layer 11 is also made of glass or the like.

[0030] The detection layer 12 is located above the substrate layer 11 and is the core of the detection component 10. Through capillary action, fluid can flow without external pumping, which is crucial in the detection component 10. The detection layer 12 is mainly responsible for guiding and controlling the flow of liquids (such as blood samples) in the detection component 10.

[0031] The detection layer 12 has several microchannels (not shown in the figure). These microchannels are formed through precision machining during the manufacturing process. The design of the microchannels can utilize capillary action to control the flow of liquid, such as... Figure 1 As shown, these microchannels form a detection channel 101.

[0032] The detection layer 12 has a first cross-section, and the substrate layer 11 has a second cross-section. The first and second cross-sections are perpendicular to the stacking direction X of the substrate layer 11 and the detection layer 12, and the area of ​​the first cross-section is greater than the area of ​​the second cross-section.

[0033] That is, in this application, the detection layer 12 is designed to be slightly larger than the substrate layer 11, so that when the detection layer 12 and the substrate layer 11 are assembled, the detection layer 12 covers the substrate layer 11. In this way, the misalignment of the bonding between the upper and lower sidewalls can be reduced, the process difficulty of assembling the detection component 10 can be reduced, the design consistency of the detection component 10 can be improved, and the failure rate of sample detection can be reduced.

[0034] Furthermore, the difference between the length of the first cross-section and the length of the second cross-section is d1, where 0 < d1 ≤ 0.5 mm. The length of the first cross-section is the length of its longer side, and the length of the second cross-section is the length of its longer side. The difference between the width of the first cross-section and the width of the second cross-section is d2, where 0 < d2 ≤ 0.5 mm. The width of the first cross-section is the length of its shorter side, and the width of the second cross-section is the length of its shorter side. That is, the dimensional design deviation between the detection layer 12 and the substrate layer 11 can be 0.1 mm, 0.25 mm, 0.35 mm, or 0.5 mm, etc. This makes the detection layer 12 slightly larger than the substrate layer 11, reducing the mounting difficulty of the detection assembly 10 and improving the process consistency of the detection assembly 10. Furthermore, the deviation dimension of the upper surface of the substrate layer 11 does not exceed the deviation dimension of the lower surface of the detection layer 12.

[0035] The substrate layer 11 can be selected from standard glass slide sizes, which is suitable for more morphological inspection environments and helps to reduce costs.

[0036] Optionally, for the detection component 10 used in liquid-based imaging detection, to facilitate the formation of a stable and uniform liquid layer using capillary flow, glass can be selected as the flow channel substrate, providing excellent hydrophilicity. However, processing the flow channel using glass as the substrate is costly and has poor processing accuracy. Therefore, plastic (such as polypropylene, polyethylene, or polymethyl methacrylate) or flexible material (such as polydimethylsiloxane) is used as the cover plate. The following two methods are preferred for realizing the flow channel structure:

[0037] In some embodiments, such as Figure 2 As shown, the detection layer 12 includes a cover layer 121, and several microchannels are disposed on the cover layer 121 and on the side of the cover layer 121 that contacts the substrate layer 11. Since plastic has good injection molding performance, the cavity height and channel structure are designed on the cover layer 121, and bonding can be performed using a dispensing process.

[0038] In other embodiments, such as Figure 3 As shown, the detection layer 12 includes a flow channel layer 122 and a cover layer 121. The flow channel layer 122 is located between the cover layer 121 and the substrate layer 11, and has several microchannels. The flow channel layer 122 can be a pressure-sensitive adhesive layer. The flow channel structure is designed on the pressure-sensitive adhesive, and a method of pressing and bonding upper and lower flat plates is used. Pressure-sensitive adhesive is an adhesive that can produce adhesion under certain pressure. The pressure-sensitive adhesive has microchannels etched on it, and its good adhesion ensures stable adhesion of the microchannel structure to various substrates.

[0039] In the above embodiment, the cover plate layer 121 is located above the flow channel layer 122. The main function of the cover plate layer 121 is to cover the flow channel layer 122, protect the microchannel from external contamination, and form a closed microchannel together with the flow channel layer 122.

[0040] like Figure 1 As shown, in some embodiments, the cover plate layer 121 is designed with a sample inlet 123 and an air outlet 124. Specifically, one end of the cover plate layer 121 is provided with a sample inlet 123 that communicates with one end of the detection channel 101, and the other end of the cover plate layer 121 is provided with an air outlet 124 that communicates with the other end of the detection channel 101. The sample inlet 123 is used to introduce liquid, while the air outlet 124 is used to balance the pressure and ensure that the liquid can pass smoothly through the detection channel 101.

[0041] In some embodiments, such as Figure 1 As shown, the detection component 10 may include three spaced-apart detection channels 101. The cover layer 121 has a sample application port 123 and an air outlet 124 at both ends of each detection channel 101. These three detection channels 101 can be used to acquire images of white blood cells, red blood cells, and platelet cells, respectively. This method improves the efficiency of a single blood routine test.

[0042] Of course, in other embodiments, the detection component 10 may also be provided with only 1, 2 or 4 detection channels 101, which can be selected and set according to actual needs. This application does not make a specific limit on the number of detection channels 101.

[0043] like Figure 1 As shown, a positioning part 125 is provided on the side of the cover plate layer 121 away from the substrate layer 11. The positioning part 125 is configured to position the placement direction of the detection component 10. The positioning part 125 is a foolproof structure design for the detection component 10.

[0044] The sample loading port 123 of the detection component 10 faces upwards, and the detection area is relatively fixed. There are strict requirements for the correct placement of the detection component 10. If it is misplaced, it will cause image abnormalities. Therefore, a matching structure with the insertion port of the sample analyzer can be set on the cover plate layer 121 to ensure that it can be inserted only in the correct direction.

[0045] exist Figure 1 In the illustrated embodiment, the positioning part 125 is a groove provided on one side of the cover plate layer 121, that is, a step of a certain height is formed on one side of the cover plate layer 121. This method has a simple manufacturing process and low manufacturing cost.

[0046] like Figure 1As shown, a handheld part 126 may be provided on the side of the cover plate layer 121 opposite to the substrate layer 11. The handheld part 126 is used for the user to hold the device, restricting the user's touch of the detection area and avoiding contamination of the detection area's field of vision.

[0047] Optionally, one side of the cover layer 121 may have a plurality of protrusions or grooves to form a handle 126. This increases the grip resistance of the handle 126 and prevents the detection component 10 from slipping and being damaged.

[0048] like Figure 1 As shown, an indicator 127 is provided on the side of the cover plate layer 121 opposite to the substrate layer 11. The indicator 127 is configured to indicate the insertion direction of the detection component 10. The indicator 127 can be an indicator arrow. The indicator arrow can more intuitively indicate the insertion direction of the detection component 10. In other embodiments, the indicator 127 can also be a character used to describe the insertion direction of the detection component 10.

[0049] In summary, the detection component 10 provided in this application has a simple structure and low cost. By optimizing the design details of the upper and lower pieces of the detection component 10, the assembly process difficulty of the detection component 10 is reduced, the process consistency is improved, the cost of consumables is reduced, the failure rate is reduced, and the performance of the detection component 10 is guaranteed.

[0050] This application also provides a sample analyzer; please refer to [link / reference]. Figure 4 As shown, Figure 4 This is a schematic diagram of an embodiment of a sample analyzer provided in this application. Specifically, the sample analyzer 200 includes a detection component 10 and a detection device 20. The detection device 20 is used to detect the detection component 10.

[0051] The detection device 20 includes a detection seat 21, a microscope component 23, and an analysis device 22.

[0052] The detection seat 21 is provided with a fixing slot 211, and the detection component 10 is snapped into the fixing slot 211. The microscope component 23 is used to acquire detection images in the image acquisition area of ​​the detection component 10. Since the field of view of the microscope component 23 is very small, the sample analyzer 200 can control the microscope component 23 to move on the image acquisition area of ​​the detection component 10 in order to acquire detection images.

[0053] The analysis device 22 can be disposed on one side of the detection seat 21. The analysis device 22 is used to analyze the detection image to obtain the detection result of the sample. The configuration of the analysis device 22 is within the scope of what those skilled in the art can understand, and will not be described in detail here.

[0054] The detection component 10 can be any of the detection components 10 described in the above embodiments. For the structure of the detection component 10, please refer to the description of any of the above embodiments, which will not be repeated here.

[0055] In this embodiment, the sample analyzer 200 can be a blood sample analyzer, and the detection component 10 can be used to perform cell detection on the blood sample. In other embodiments, the sample analyzer 200 can also be other body fluid analyzers, such as a urine analyzer.

[0056] In the sample analyzer 200 of this application, by optimizing the design of the upper and lower wafers of the detection component 10, the manufacturing process difficulty of the detection component 10 is reduced, the consistency of the detection component 10 is improved, the cost of consumables is reduced, the failure rate of detection is reduced, and the performance of the detection component 10 is guaranteed.

[0057] The above description is merely an embodiment of this application and does not limit the patent scope of this application. Any equivalent structural or procedural transformations made using the content of this application's specification and drawings, or direct or indirect applications in other related technical fields, are similarly included within the patent protection scope of this application.

Claims

1. A detection assembly comprising: The detection component includes: Substrate layer; A detection layer is disposed on the substrate layer, and the detection layer is provided with a plurality of microchannels, which form a detection channel. The detection layer has a first cross-section, and the substrate layer has a second cross-section. The first cross-section and the second cross-section are perpendicular to the stacking direction of the substrate layer and the detection layer, and the area of ​​the first cross-section is greater than the area of ​​the second cross-section.

2. The detection component according to claim 1, characterized in that, The difference between the length of the first cross-section and the length of the second cross-section is d1, where 0 < d1 ≤ 0.5 mm; The difference between the width of the first cross-section and the width of the second cross-section is d2, where 0 < d2 ≤ 0.5 mm.

3. The detection assembly of claim 1, wherein, The detection layer includes a flow channel layer and a cover plate layer. The flow channel layer is located between the cover plate layer and the substrate layer, and the flow channel layer has the plurality of microchannels.

4. The detection assembly of claim 3, wherein, The flow channel layer is a pressure-sensitive adhesive layer.

5. The detection assembly of claim 1, wherein, The detection layer includes a cover plate layer, and the plurality of microchannels are disposed on the side of the cover plate layer that contacts the detection layer.

6. The detection assembly of any one of claims 3-5, wherein, The cover plate layer has a positioning part on the side opposite to the substrate layer, and the positioning part is configured to position the placement direction of the detection component.

7. The detection assembly of any one of claims 3-5, wherein, The cover plate layer has a hand-held portion on the side opposite to the substrate layer.

8. The detection assembly of claim 7, wherein, The cover plate layer has several protrusions or grooves on one side to form the hand grip.

9. The detection assembly of any one of claims 3-5, wherein, The cover plate layer has an indicator on the side opposite to the substrate layer, and the indicator is configured to indicate the insertion direction of the detection component.

10. A sample analyzer characterized by, The sample analyzer includes: The detection component according to any one of claims 1-9; A detection device for detecting the detection component.

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