A reagent card and a sample analyzer

Abstract

The application discloses a reagent card and a sample analyzer. The reagent card comprises a cover plate layer, a detection layer and a substrate layer. The detection layer is arranged on the substrate layer and is provided with a plurality of micro flow channels along the extension direction of the detection layer, and the plurality of micro flow channels form a detection channel. The cover plate layer is arranged on the detection layer, one end of the cover plate layer is provided with a sample adding port in communication with one end of the detection channel, and the other end of the cover plate layer is provided with an air outlet in communication with the other end of the detection channel. The detection channel comprises an image acquisition area, and the distance between the image acquisition area and the sample adding port is not less than 4 mm. After the reagent card is placed into the sample analyzer, the sample analyzer is used for controlling a microscope component to detect and acquire an image of the image acquisition area. In the application, the image acquisition area of the reagent card is far away from the sample adding port, the liquid flow velocity fluctuation of the image acquisition area is small, so that the uniformity of particle distribution in the liquid can be improved, and when the particles are analyzed based on the image acquisition area, the accuracy of the sample detection result can be improved.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a reagent card and 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 reagent card, as the platform for sample carrying and reaction, has a decisive impact on the accuracy of the detection results.

[0003] Current image-based diagnostic test strips primarily utilize capillary action to introduce the sample into the detection area of ​​the strip, followed by imaging and analysis of the cells using a microscope or imaging equipment. In the design of the test strip, the selection of the image acquisition area is a critical technical issue, directly impacting the accuracy and reliability of the test results.

[0004] In existing technologies, a region is usually randomly selected in the middle of the detection channel as the image acquisition area. This method may result in poor uniformity of particle distribution in the image acquisition area. Summary of the Invention

[0005] This application provides a reagent card and a sample analyzer to solve the technical problem in the prior art that randomly delineating a region in the middle of the detection channel as an image acquisition area may result in poor uniformity of particle distribution in the image acquisition area.

[0006] To solve the above-mentioned technical problems, one technical solution adopted in this application is: providing a reagent card, which includes a cover layer, a detection layer, and a substrate layer. The detection layer is disposed on the substrate layer, and a plurality of microchannels are arranged along its extension direction, forming a detection channel. The cover layer is disposed on the detection layer, with a sample dispensing port at one end of the cover layer communicating with one end of the detection channel, and an air outlet at the other end of the cover layer communicating with the other end of the detection channel. The detection channel includes an image acquisition area, and the distance between the image acquisition area and the sample dispensing port is not less than 4 mm. After the reagent card is placed into a sample analyzer, the sample analyzer controls the microscope components to acquire detection images of the image acquisition area.

[0007] Furthermore, the length of the image acquisition area along the first direction is less than the length of the image acquisition area along the second direction, wherein the first direction is parallel to the extension direction of the microchannel, and the second direction is perpendicular to the first direction.

[0008] Furthermore, the distance between the side edge of the image acquisition area and the edge of the detection channel is not less than twice the height of the detection layer.

[0009] Furthermore, the distance between the side edge of the image acquisition area and the edge of the detection channel is not less than 2mm.

[0010] Furthermore, the distance between the image acquisition area and the air outlet is not less than 3mm.

[0011] Furthermore, the height of the detection layer is greater than 100 micrometers.

[0012] Furthermore, the length of the detection channel is not less than 12mm, wherein the length direction of the detection channel is the same as the extension direction of the microchannel.

[0013] Furthermore, the width of the detection channel is the same as the width of the air outlet, wherein the width direction of the detection channel and the width direction of the air outlet are both perpendicular to the extension direction of the microchannel.

[0014] Furthermore, the cover plate layer or the substrate layer is provided with a positioning part, which is used to position the reagent card during installation.

[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 seat, an analysis device, and a reagent card of any of the above embodiments, wherein the detection seat is provided with a fixing slot; the reagent card is snapped into the fixing slot; a microscope component is used to acquire detection images of the image acquisition area of ​​the reagent card; and the analysis device is used to detect and analyze the detection images.

[0016] The beneficial effects of this application are as follows: Unlike existing technologies, the reagent card of this application includes a cover layer, a detection layer, and a substrate layer. The detection layer is disposed on the substrate layer and has several microchannels along its extension direction, forming a detection channel. The cover layer is disposed on the detection layer, with a sample dispensing port at one end communicating with one end of the detection channel, and an air outlet at the other end communicating with the other end of the detection channel. The detection channel includes an image acquisition area, and the distance between the image acquisition area and the sample dispensing port is not less than 4 mm. After the reagent card is placed in the sample analyzer, the sample analyzer controls the microscope components to acquire detection images of the image acquisition area. The reagent card provided by this application has a greater distance between the image acquisition area and the sample dispensing port, thus reducing the influence of the sample dispensing port on the image acquisition area. The liquid flow rate fluctuation within the image acquisition area is smaller, thereby improving the uniformity of particle distribution within the image acquisition area. When analyzing particles based on this image acquisition area, the accuracy and reliability of the detection results can be improved. 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 one embodiment of a reagent card provided in this application;

[0019] Figure 2 yes Figure 1 A side view of the reagent card shown;

[0020] Figure 3 This is a schematic diagram of a rectangular microchannel structure;

[0021] Figure 4 This is a schematic diagram of the curve structure showing the effect of the detection layer height on liquid flow in the reagent card;

[0022] Figure 5 This is a schematic diagram of the curve structure showing the effect of the detection layer height on the flow rate in the reagent card;

[0023] Figure 6 This is a schematic diagram simulating a phase interface with spontaneous capillary flow within a reagent card;

[0024] Figure 7 This is a schematic diagram showing the relationship between particle flow resistance and relative velocity in the detection layer;

[0025] Figure 8 This is a flow rate distribution graph for reagent cards of different sizes calculated in COMSOL;

[0026] Figure 9 This is a schematic diagram of flow velocity fluctuations at different locations in the detection layer;

[0027] Figure 10 yes Figure 1 The diagram shown is a structural schematic of a single detection channel in the reagent card.

[0028] Figure 11 This is a schematic diagram of the structure of a sample analyzer provided in this application.

[0029] Figure descriptions: 10. Reagent card; 11. Substrate layer; 12. Detection layer; 13. Cover layer; 131. Sample dispensing port; 132. Air outlet; 133. Positioning part; 121. Detection channel; 122. Image acquisition area; 20. Sample analyzer; 21. Detection seat; 22. Analytical device; 211. Fixing slot; 23. Microscope component. Detailed Implementation

[0030] 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.

[0031] 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.

[0032] 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.

[0033] In the field of biomedical testing, image-based detection technology is widely used in cell counting, cell morphology analysis, and other scenarios due to its intuitive and efficient characteristics. This technology typically relies on reagent cards as a sample carrier and reaction platform, acquiring cell images through image acquisition devices for counting and analysis.

[0034] This application provides a reagent card that improves the consistency of particle distribution and thus the accuracy of sample detection results by optimizing the height of the detection layer, the length of the detection channel, the layout of the image acquisition area, and the material selection. The structure and related parameters of the reagent card provided in this application will be described in detail below.

[0035] Please see Figure 1 and Figure 2 As shown, Figure 1 This is a schematic diagram of one embodiment of a reagent card provided in this application. Figure 2 yes Figure 1 The side view of the reagent card shown is a schematic diagram. Specifically, the reagent card 10 includes a substrate layer 11, a detection layer 12, and a cover layer 13 stacked in sequence.

[0036] The substrate layer 11 of the reagent card 10 is the foundation of the entire reagent card 10 structure, providing support for the detection layer 12 and the cover layer 13. The design and material selection of the substrate layer 11 have a significant impact on the performance of the reagent card 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 and the cover layer 13 while maintaining structural integrity during operation.

[0037] 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.

[0038] The detection layer 12 is located above the substrate layer 11 and is the core of the reagent card 10. Through capillary action, fluid can flow without external pumping, which is crucial in the reagent card 10. The detection layer 12 is mainly responsible for guiding and controlling the flow of liquids (such as blood samples) in the reagent card 10.

[0039] The detection layer 12 has several microchannels (not shown) along its extension direction. These microchannels are formed through precision machining during manufacturing. The design of the microchannels can utilize capillary action to control the flow of liquid, such as... Figure 10 As shown, the plurality of microchannels form a detection channel 121. The detection channel 121 includes an image acquisition area 122, which is used to acquire detection images for detection analysis.

[0040] The material of the detection layer 12 can be PSA (pressure sensitive adhesive). PSA is an adhesive that can produce adhesion under certain pressure. PSA adhesive has microchannels engraved on it, and its good adhesion can ensure that the microchannel structure adheres stably to various substrates.

[0041] The cover layer 13 is located above the detection layer 12. The main function of the cover layer 13 is to cover the detection layer 12, protecting the microchannels from external contamination, and together with the detection layer 12, forming a closed microchannel system. The material of the cover layer 13 can be varied; for example, it can be glass, plastic (such as polypropylene, polyethylene, or polymethyl methacrylate), or flexible materials (such as polydimethylsiloxane). When selecting a material, its transparency, chemical stability, biocompatibility, and bonding compatibility with the detection layer 12 must be considered.

[0042] like Figure 1 and Figure 10The cover plate layer 13 is designed with a sample inlet 131 and an air outlet 132. Specifically, one end of the cover plate layer 13 is provided with a sample inlet 131 that communicates with one end of the detection channel 121, and the other end of the cover plate layer 13 is provided with an air outlet 132 that communicates with the other end of the detection channel 121. The sample inlet 131 is used to introduce liquid, while the air outlet 132 is used to balance the pressure and ensure that the liquid can pass smoothly through the detection channel 121.

[0043] In some embodiments, such as Figure 1 and Figure 10 As shown, the reagent card 10 may include three spaced-apart detection channels 121. The cover layer 13 has a sample application port 131 and an air outlet 132 at both ends of each detection channel 121. These three detection channels 121 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 complete blood count test.

[0044] Of course, in other embodiments, the reagent card 10 may also be provided with only 1, 2 or 4 detection channels 121, which can be selected and set according to actual needs. This application does not make a specific limit on the number of detection channels 121.

[0045] Furthermore, to ensure good consistency in the height of the detection layer 12 of the reagent card 10, the reagent card 10 can be mounted using PSA bonding technology or UV (Ultraviolet) dispensing bonding technology, etc.

[0046] The parameter design of reagent card 10 will be described in detail below.

[0047] When using reagent card 10, capillary action is the key mechanism for the spontaneous flow of liquids in microchannels. Capillary action is the result of the interaction between the cohesive forces within liquid molecules and the adhesive forces between the liquid and the solid. When the free energy of the liquid-solid interface is less than that of the liquid-gas interface within the microchannel, the liquid-solid interface will replace the liquid-gas interface, causing the system's free energy to approach a minimum, thus resulting in capillary action. For example, the conditions for the formation of spontaneous capillary action include material and geometric conditions; see [reference needed]. Figure 3 The spontaneous capillary conditions of the rectangular channel shown are as follows:

[0048] When the sides are hydrophilic, that is... Figure 3 When both θ2 and θ4 are less than 90 degrees, the aspect ratio requirement is: Where W is the width of the rectangular channel, H is the height of the rectangular channel, and θ1, θ2, θ3 and θ4 are the contact angles.

[0049] When the sides are hydrophobic, and both θ2 and θ4 are greater than 90 degrees, the aspect ratio requirement is: And it is necessary to satisfy the prerequisite θ1+θ3<π.

[0050] In some embodiments, the detection layer 12 is made of PSA adhesive, and the sides of the microchannel are hydrophobic. Therefore, at least one of the materials of the cover layer 13 and the substrate layer 11 needs to be a hydrophilic material. Considering the capillary filling effect, the material of the cover layer 13 or the substrate layer 11 and the height of the detection layer 12 need to be designed. The influence of the material of the cover layer 13 or the substrate layer 11 and the height of the detection layer 12 on the liquid flow is as follows: Figure 4 As shown, from Figure 4 As can be seen, the capillary force of glass is significantly greater than the flow resistance of liquid, which can produce a better capillary effect.

[0051] The influence of the detection zone height and the material of the cover layer 13 or the substrate layer 11 on the flow rate is as follows: Figure 5 As shown, from Figure 5 As can be seen, the height of the detection layer 12 has a significant impact on the liquid flow rate; the flow rate increases with the increase of the detection layer 12 height. Furthermore, the flow rate increase rate and final flow rate of the glass material are both higher than those of the polymethyl methacrylate material.

[0052] Therefore, at least one of the cover layer 13 and the substrate layer 11 can be made of glass.

[0053] In some embodiments, polymethyl methacrylate (plastic) can be selected as the material of the substrate layer 11, with a contact angle of approximately 88° and low hydrophilicity. When glass is selected as the cover layer 13, its capillary effect is significantly stronger than that of polymethyl methacrylate. Therefore, glass can be selected as the material of the cover layer 13, with a contact angle of 20°-40° and good hydrophilicity.

[0054] In some embodiments, the cover layer 13 can be made of plastic, and the substrate layer 11 can be made of glass. Since the cover layer 13 needs to have openings, this method eliminates the need to make openings in the glass, which facilitates the fabrication of the reagent card 10. In other embodiments, both the cover layer 13 and the substrate layer 11 can be made of glass, which can improve capillary action and facilitate the flow of liquid in the detection layer 12.

[0055] In addition, from Figure 5 As can be seen, the greater the height of the detection layer 12, the faster the liquid flows through it. Preferably, the height of the detection layer 12 is not less than 100 micrometers, such as 100 micrometers, 110 micrometers, 120 micrometers, 130 micrometers, or 150 micrometers. This results in a faster liquid flow rate and lower flow resistance, thus increasing the liquid flow speed within the detection channel 121, improving detection efficiency, and enabling a more uniform distribution of the liquid within the detection channel 121.

[0056] For example, in COMSOL, a two-phase flow-phase field model is used to construct the physical field for spontaneous capillary action. The phase field model calculation is more accurate than that of a level set. The inlet and flow regions are simulated, and the contact angles of the wetting walls made of different materials are set. The cover layer 13 is made of glass, and the contact angle θ of the cover layer 13 is... t The contact angle θ is 30°, the substrate layer 11 is made of plastic, and the substrate layer 11 has a contact angle of θ. t The angle is 88°, the length of the detection channel 121 is 12 mm, and the channel height is 150 μm. At this time, the phase interface of spontaneous capillary flow is as follows: Figure 6 As shown in the figure, the liquid flow rate is relatively fast and the flow is relatively uniform.

[0057] like Figure 10 As shown, the detection channel 121 includes an image acquisition area 122, which is used to acquire detection images. After the reagent card 10 is inserted into the sample analyzer, the sample analyzer controls the microscope component to acquire detection images from the image acquisition area 122.

[0058] The image acquisition area 122 is only involved when the reagent card 10 is used. Generally, the detection image is acquired in the image acquisition area by the microscope component. Since the field of view of the microscope component is very small, it is necessary to move on the image acquisition area 122 to acquire the detection image.

[0059] Furthermore, the image acquisition area 122 is a region, which can be marked on the reagent card 10, and the microscope component can acquire images based on the marked region. In other embodiments, the image acquisition area 122 may not be marked, but rather determined by controlling the movement of the microscope component; that is, the image acquisition area 122 is determined based on the actual sampling area of ​​the microscope component.

[0060] In the design of reagent card 10, the image acquisition area 122 is a crucial component, used to capture the reaction results on reagent card 10 for subsequent analysis and interpretation. Therefore, the liquid flow rate fluctuation in the image acquisition area 122 should be small to ensure a more uniform distribution of particles in the liquid (such as cells in a blood sample).

[0061] The selection of the image acquisition area 122 of reagent card 10 will be described in detail below.

[0062] In a suspended state, the forces acting on particles typically consist of two parts: the force exerted by the fluid on the particles and the force exerted by the applied potential field on the particles. In this microfluidic system, the particle volume concentration is low, so the interaction between particles and the feedback effect of particle motion on the flow field can be ignored. Furthermore, there is no applied potential field, so only the force exerted by the fluid on the particles is considered.

[0063] The force exerted on a particle in a capillary-flowing liquid is the resistance F generated by the fluid on the particle. D Stokes resistance, also known as drag, is expressed as:

[0064] F D =6π*μ*a*V p ,

[0065] Where μ is the solution viscosity coefficient, a is the particle size, and V p The velocity of the particle.

[0066] Therefore, the factors affecting particle distribution include: particle velocity Vp (which depends on the flow rate), solution viscosity coefficient, density ratio, and particle size a.

[0067] When a fluid has a flow velocity, there is a vector difference between the particle velocity and the fluid velocity. The relationship between flow resistance and relative velocity is illustrated in the diagram below. Figure 7 As shown. Figure 7 The black dot in the diagram represents a particle moving in the fluid. The curves in the diagram represent streamlines, showing the instantaneous velocity direction of the fluid particle. The fluid velocity vector is V, the particle velocity vector is Vp, and there is a vector difference ΔV between the particle velocity Vp and the fluid velocity V. The drag force acting on the particle is F. D The drag force F experienced by the particle D It is positively correlated with the velocity vector difference ΔV.

[0068] Based on the above principles, the basic structure of the detection channel 121 of reagent card 10 is designed, including the sample inlet 131, the gas outlet 132, and the dimensions of the detection channel 121. Its flow rate distribution is calculated in COMSOL as follows: Figure 8 As shown.

[0069] from Figure 8 As can be seen, there are flow velocity fluctuations at both the sample inlet 131 and the outlet 132. Figure 8 In the upper left image, the width and length of detection channel 121 are 10mm and 16mm respectively, and the width of outlet 132 is 4mm. The flow velocity is higher near outlet 132, and the color is reddish and yellowish, indicating that the flow velocity in these areas is faster. Figure 8 Compared to the upper right image (the size of detection channel 121 is 10mm*12mm), it can be seen that the longer the length of detection channel 121, the smaller the flow rate fluctuation.

[0070] Figure 8In the lower left image, the detection channel 121 measures 10mm x 16mm, and the outlet 132 is 10mm wide. The flow velocity is relatively uniformly distributed near the outlet 132, and the colors are mainly green and yellow, indicating a relatively high flow velocity. Due to the larger width of the outlet 132, the fluid flow is more stable, and the vortex phenomenon may not be as pronounced as in the narrower outlet 132.

[0071] Figure 8 In the lower right image, the detection channel 121 measures 6mm x 16mm, the outlet 132 is relatively narrow, and the flow velocity is high near the outlet 132. The colors are mainly red and yellow, indicating that the flow velocity in these areas is very fast.

[0072] As shown in the figure above, the flow velocity distribution is most uniform when the width of the air outlet 132 is the same as the width of the detection channel 121. Therefore, the width of the air outlet 132 is preferably designed to be equal to the width of the detection channel 121. Both the width direction of the air outlet 132 and the width direction of the detection channel 121 are perpendicular to the extension direction of the microchannel.

[0073] Meanwhile, the greater the length of the detection channel 121, the larger the area of ​​uniform flow velocity distribution. When the length of the detection channel 121 is not less than 12 mm, the flow velocity distribution is relatively uniform. The length of the detection channel 121 is in the same direction as the extension of the microchannel.

[0074] In reagent card 10, the flow rate fluctuations at different distances from the sample dispensing port 131 are as follows: Figure 9 As shown, Figure 9 The image shows the magnitude of the liquid velocity in a certain direction at different locations (x = 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, where x represents the distance from the sample inlet 131). Figure 9 As can be seen, the flow rate fluctuation is relatively small at a distance of at least 4 mm from the sample inlet 131.

[0075] Therefore, as Figure 10 As shown, the distance L between the image acquisition area 122 and the sample dispensing port 131 in the reagent card 10 should be no less than 4 mm. This can reduce the influence of the sample dispensing port 131 on the image acquisition area, and the liquid flow rate fluctuation in the image acquisition area 122 is smaller. Therefore, it can improve the uniformity of particle distribution in the image acquisition area 122. When the particles are analyzed based on the image acquisition area 122, the accuracy and reliability of the detection results can be improved.

[0076] like Figure 10 As shown, the distance M between the image acquisition area 122 and the air outlet 132 can be no less than 3mm to reduce the influence of the air outlet 132 on the fluctuation of liquid flow rate.

[0077] Considering that particle lift caused by fluid shear in the near-wall region may lead to insufficient settling, the particle lift is generally zero at twice the height of the detection layer 12. Therefore, the distance N between the side edge of the image acquisition area 122 and the edge of the detection channel 121 should not be less than twice the height of the detection layer 12. In practical use, considering processing and positioning errors of the reagent card 10, the preferred spacing between them is not less than 2 mm.

[0078] Additionally, see Figure 10 As shown, the flow rate is fastest at the sample inlet 131 and drops to 0 at the outlet 132. The flow velocity fluctuation in the flow direction is much greater than that in the lateral direction. The flow direction is parallel to the extension direction of the microchannel, while the lateral direction is perpendicular to the flow direction.

[0079] Under normal circumstances, when the liquid flow rate is uniform, the length of the image acquisition area 122 is positively correlated with the number of sampling points (particles). However, due to large fluctuations in the flow velocity along the flow direction, the uniformity of particle distribution is affected. The design of the image acquisition area 122 should consider the characteristics of liquid flow. Since the flow velocity along the flow direction fluctuates significantly, while the lateral flow velocity is relatively stable, the length of the image acquisition area 122 along the flow direction (first direction) should be less than the length of the image acquisition area 122 along the lateral direction (second direction). That is, it is preferable to set more sampling points in the lateral direction during the design. This approach makes the particle distribution within the image acquisition area 122 more uniform, thereby improving the quality and consistency of image acquisition and the accuracy of detection results.

[0080] Furthermore, such as Figure 1 As shown, to ensure that the reagent card 10 is placed correctly, a positioning part 133 can be provided on the cover layer 13. The positioning part 133 is used to position the reagent card 10 to prevent abnormal sample injection, abnormal detection, and leakage caused by the sample inlet 131 being upside down or misplaced. In other embodiments, the positioning part 133 can also be provided on the substrate layer 11.

[0081] exist Figure 1 In the illustrated embodiment, the positioning part 133 is a groove structure and is disposed at the end of the cover layer 13. This groove can cooperate with the protrusion in the fixing slot of the reagent card 10 to position the reagent card 10 for installation. This design ensures that the cover layer 13 can only be placed in one correct orientation, thereby avoiding incorrect operation.

[0082] In some specific embodiments, the cover layer 13 has a certain thickness reserved at the position corresponding to the groove. For example, the substrate layer 11 is a glass slide produced to standard specifications, and the groove on the cover layer 13 corresponds to the protrusion in the fixing slot of the reagent card 10. When designing the groove on the cover layer 13, a certain thickness is reserved to ensure that the glass slide is fully covered. In this way, the glass slide can be effectively prevented from being crushed.

[0083] In other embodiments, the positioning portion 133 on the cover layer 13 may also be a protruding structure that engages with the groove in the fixing slot of the reagent card 10 to position the reagent card 10 for installation.

[0084] It is understood that in other embodiments, the positioning part 133 may also be provided on the substrate layer 11, as long as it can provide positioning for the installation of the reagent card 10.

[0085] The design of the positioning part 133 improves the reliability of the reagent card 10 and the ease of user operation. It reduces damage to the reagent card 10 caused by operational errors and simplifies the processing of the reagent card 10 by automated equipment.

[0086] In summary, the reagent card 10 of this application improves the uniformity of particle distribution within the image acquisition area 122 by optimizing the layout of the image acquisition area 122, thereby reducing particle measurement errors. Furthermore, by optimizing the height of the detection layer 12, the size of the detection channel 121, and the selection of materials, the consistency of particle distribution within the image acquisition area 122 and the accuracy of the detection results are further improved, thereby reducing consumable costs.

[0087] This application also provides a sample analyzer; please refer to [link / reference]. Figure 11 As shown, Figure 11 This is a schematic diagram of an embodiment of a sample analyzer provided in this application. Specifically, the sample analyzer 20 includes a detection seat 21, a reagent card 10, a microscope component 23, and an analysis device 22.

[0088] The detection seat 21 is provided with a fixing slot 211, in which the reagent card 10 is snapped into the fixing slot 211; the microscope component 23 is used to acquire detection images of the image acquisition area of ​​the reagent card 10. Since the field of view of the microscope component 23 is very small, specifically, the sample analyzer 20 can control the microscope component 23 to move on the image acquisition area of ​​the reagent card 10 to acquire detection images.

[0089] 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.

[0090] The reagent card 10 can be any of the reagent card 10 described in the above embodiments. For the structure of the reagent card 10, please refer to the description of any of the above embodiments, which will not be repeated here.

[0091] In this embodiment, the sample analyzer 20 can be a blood sample analyzer, and the reagent card 10 can be used for cell detection of blood samples. In other embodiments, the sample analyzer 20 can also be other body fluid analyzers, such as a urine analyzer.

[0092] In the sample analyzer 20 of this application, by optimizing some parameters of the reagent card 10 (such as the height of the detection layer, the size of the detection channel, the layout of the image acquisition area, and the material selection), the consistency of particle distribution in the image acquisition area can be achieved, thereby improving the accuracy of sample detection results.

[0093] 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 reagent card, characterized in that, The reagent card includes: Substrate layer; A detection layer is disposed on the substrate layer, and the detection layer has a plurality of microchannels along its extension direction, the plurality of microchannels forming a detection channel; A cover plate layer is placed on the detection layer. One end of the cover plate layer is provided with a sample inlet that communicates with one end of the detection channel, and the other end of the cover plate layer is provided with an air outlet that communicates with the other end of the detection channel. The detection channel includes an image acquisition area, and the distance between the image acquisition area and the sample application port is not less than 4 mm; after the reagent card is placed into the sample analyzer, the sample analyzer is used to control the microscope component to acquire detection images of the image acquisition area.

2. The reagent card according to claim 1, characterized in that, The length of the image acquisition area along the first direction is less than the length of the image acquisition area along the second direction, wherein the first direction is parallel to the extension direction of the microchannel, and the second direction is perpendicular to the first direction.

3. The reagent card according to any one of claims 1-2, characterized in that, The distance between the side edge of the image acquisition area and the edge of the detection channel is not less than twice the height of the detection layer.

4. The reagent card according to claim 3, characterized in that, The distance between the side edge of the image acquisition area and the edge of the detection channel is not less than 2mm.

5. The reagent card according to claim 1, characterized in that, The distance between the image acquisition area and the air outlet is not less than 3mm.

6. The reagent card according to claim 1, characterized in that, The height of the detection layer is greater than 100 micrometers.

7. The reagent card according to claim 1, characterized in that, The length of the detection channel is not less than 12 mm, wherein the length direction of the detection channel is parallel to the extension direction of the microchannel.

8. The reagent card according to claim 1, characterized in that, The width of the detection channel is the same as the width of the air outlet, wherein the width direction of the detection channel and the width direction of the air outlet are both perpendicular to the extension direction of the microchannel.

9. The reagent card according to claim 1, characterized in that, The cover plate layer or the substrate layer is provided with a positioning part, which is used to position the reagent card for installation.

10. A sample analyzer, characterized in that, The sample analyzer includes: The testing base is equipped with a fixing slot; The reagent card according to any one of claims 1-9 is snapped into the fixing slot; A microscope component is used to acquire detection images of the image acquisition area of ​​the reagent card; An analysis device is used to perform detection and analysis on the detected image.

Images