Immunochromatography reagent card and detection system and analyzer thereof

Abstract

The utility model discloses an immunochromatography reagent card which comprises an upper card shell, a lower card shell and a test strip, the upper card shell covers the lower card shell, the test strip is located between the upper card shell and the lower card shell, a blending pool is arranged on the upper card shell or the lower card shell, a reagent restraining structure is arranged in the blending pool, and the reagent restraining structure is arranged in the blending pool. And a solid-state reagent is restrained in the reagent restraining structure. The utility model also provides an immunochromatography reagent card detection system and an analyzer. According to the immunochromatography reagent card as well as the detection system and the analyzer thereof, disclosed by the utility model, not only can the uniform mixing operation of a diluent and a sample solution be realized, but also the uniform mixing operation of the diluent, the sample solution and a solid fluorescent reagent can be realized.

Description

Technical Field

[0001] The utility model belongs to the technical field of in vitro detection, and specifically relates to an immunochromatographic reagent card and a detection system and an analyzer thereof. Background Art

[0002] In the prior art, the diluent and the sample solution are generally mixed outside the reagent card, that is, after the diluent and the sample solution are mixed outside the reagent card, the mixed solution is injected into the reagent card through the sampling needle for detection. However, due to the variety of detection items, the sample solution for each detection is also different. Therefore, after each mixing and detection, the mixing component needs to be cleaned, which not only reduces the detection efficiency, but also the cleaning residue may affect the subsequent detection.

[0003] Since the reagent card is a disposable consumable, it is possible to consider integrating the mixing structure directly into the reagent card. In this way, the mixing of the diluent and the sample liquid can be completed directly on the reagent card. After mixing, the mixed liquid can be directly transferred to the test paper in the reagent card for reaction, thereby avoiding the need to clean the mixing components after each test, improving detection efficiency and avoiding cross contamination.

[0004] In some fluorescent immunoassays, solid fluorescent reagents are also needed. The ordinary mixing structure integrated in the reagent card can only achieve the mixing of the diluent and the sample liquid, and cannot perform the mixing operation of the sample liquid and the solid fluorescent reagent. Therefore, in the face of fluorescent immunoassay, one method is to complete the mixing of the sample liquid and the fluorescent reagent by setting up a separate fluorescent reagent mixing pool, which requires an additional separate mixing step of the diluted sample and the fluorescent reagent, which will increase the complexity of the steps, the volume of the instrument and the detection cost. Another method is to use microfluidics to achieve the mixing of the diluted sample liquid and the fluorescent reagent in the microfluidic channel, but the microfluidic solution has high requirements for the microfluidic channel design of the reagent card, high processing and manufacturing costs, and the product stability of the microfluidic reagent card is difficult to guarantee.

[0005] Therefore, it is necessary to provide a simple and efficient immunochromatographic reagent card for fluorescent immunoassay and a detection system and analyzer thereof. Summary of the invention

[0006] In view of this, the purpose of the utility model is to provide an immunochromatographic reagent card and a detection system and analyzer thereof, which can achieve the mixing operation of the diluent and the sample solution, and can also achieve the mixing operation of the diluent, the sample solution and the solid fluorescent reagent.

[0007] In order to achieve the above object, the utility model provides the following technical solutions:

[0008] The utility model firstly proposes an immunochromatographic reagent card, comprising an upper card shell, a lower card shell and a test strip, wherein the upper card shell is covered on the lower card shell, the test strip is located between the upper card shell and the lower card shell, a mixing pool is provided on the upper card shell or the lower card shell, a reagent restraining structure is provided in the mixing pool, and a solid reagent is restrained in the reagent restraining structure. Furthermore, the solid reagent is a solid fluorescent reagent.

[0009] Furthermore, the reagent restraint structure is at least used to restrain the liquid reagent by surface tension before the mixing operation and store the solid reagent obtained after the liquid reagent is dried or freeze-dried, and the reagent restraint structure is a rough structure and / or an enclosure structure.

[0010] Furthermore, the reagent restraining structure is a retaining structure having a retaining portion and an opening portion. The retaining portion is used to restrain the liquid reagent by surface tension before the mixing operation and to store the solid reagent obtained after the liquid reagent is dried or freeze-dried, and the opening portion is used for the reagent discharged from the sampling needle to flow in and mix with the solid reagent.

[0011] Furthermore, the inner side surface of the enclosure portion includes at least one curved surface or at least two adjacent flat surfaces.

[0012] Furthermore, the horizontal cross-sectional profile of the inner side surface of the enclosure portion is U-shaped, V-shaped, circular arc-shaped or elliptical arc-shaped.

[0013] Furthermore, the width of the opening is less than or equal to 5 mm, preferably less than or equal to 3.5 mm.

[0014] Furthermore, the reagent restraint structure is arranged in a non-bottom area of ​​the mixing tank.

[0015] Furthermore, a pool bottom is provided in the mixing pool, a first inclined surface is provided on one side of the pool bottom, and at least a part of the reagent restraint structure is arranged on the first inclined surface.

[0016] Further, the first inclined surface is a plane or a curved surface, and there is at least one point A on the first inclined surface, and the angle α between the normal of the tangent plane at the point A and the normal of the horizontal plane is 10°-60°, preferably 15°-45°, and most preferably 18°-30°. Optionally, when the first inclined surface is a curved surface, there is at least one first sub-region on the first inclined surface, and the angle between the normal of the tangent plane at any point in the first sub-region and the normal of the horizontal plane satisfies the range of angle α. Preferably, the first sub-region is the region corresponding to the solid reagent. More preferably, the first sub-region is the region corresponding to the reagent constraint structure.

[0017] Further, a second inclined surface is provided on the other side of the pool bottom surface opposite to the first inclined surface, the second inclined surface is a plane or a curved surface, there is at least one point B on the first inclined surface, the angle between the normal of the tangent plane at the point B and the normal of the horizontal plane is β, the angle β is 45°≤β≤90°, preferably 60°≤β≤85°, and the angle β is greater than the angle α. Optionally, when the second inclined surface is a curved surface, there is at least one second sub-region on the second inclined surface, and the angle between the normal of the tangent plane at any point in the second sub-region and the normal of the horizontal plane satisfies the range of the angle β.

[0018] Further, the angle between the normal of the tangent plane at any point on the first inclined plane and the normal of the horizontal plane satisfies the range of angle α; and / or the angle between the normal of the tangent plane at any point on the second inclined plane and the normal of the horizontal plane satisfies the range of angle β.

[0019] Furthermore, the bottom surface of the pool is oval, circular, elliptical, square or rounded square, and the top of the mixing pool is provided with a top frame, and the horizontal cross-sectional profile of the top frame is oval, circular, elliptical, square or rounded square.

[0020] Further, the bottom surface of the pool is circular with a radius of r1, the horizontal cross-sectional profile of the top frame is an oval circle, and the top frame includes a first semicircular arc segment and a second semicircular arc segment that are arranged opposite to each other; the center of the bottom surface of the pool and the center of the first semicircular arc segment and the projection of the center of the second semicircular arc segment on the horizontal plane are located on the same straight line, and the first distance L1 between the center of the bottom surface of the pool and the center of the first semicircular arc segment is smaller than the second distance L2 between the center of the bottom surface of the pool and the center of the second semicircular arc segment;

[0021] The transition slope between the pool bottom surface and the first semicircular arc segment forms the first slope, and the transition slope between the top frame and the second semicircular arc segment forms the second slope.

[0022] Further, the radius of the first semicircular arc segment and the second semicircular arc segment is r2, and r2≥r1, preferably r2 is greater than r1.

[0023] Furthermore, r1 is between 2-10 mm, preferably between 3-6 mm.

[0024] Furthermore, the minimum distance c between the reagent restraining structure and the bottom surface of the pool in the vertical direction is greater than or equal to the distance between the liquid outlet and the needle tip of the sampling needle.

[0025] Furthermore, a spot hole is provided on the upper casing corresponding to the test strip, and the spot hole is a circular hole or a long hole with a long axis; and when the spot hole is a long hole, the angle δ between the long axis of the mixing pool and the long axis of the spot hole satisfies:

[0026]

[0027] Among them, when the sample spotting hole is located on the radially inward side of the mixing pool, D1 is the distance between the sample spotting hole and the center of the incubation plate; when the mixing pool is located on the radially inward side of the sample spotting hole, D1 is the distance between the mixing pool and the center of the incubation plate; D2 is the distance between the mixing pool and the sample spotting hole; D3 is the distance between the needle sample spotting position and the needle mixing position; Δδ is the allowable angular error.

[0028] Furthermore, an observation window is provided on the upper casing corresponding to the test strip, and the mixing pool, the spotting hole and the observation window are independently arranged at intervals from each other.

[0029] Furthermore, the observation window is arranged between the mixing pool and the spotting hole; or the spotting hole is arranged between the mixing pool and the observation window.

[0030] The utility model also provides an immunochromatographic reagent card detection system, which comprises a sampling needle assembly, an incubation disk assembly, a detection device and the immunochromatographic reagent card as described above.

[0031] Furthermore, the sampling needle comprises at least three working positions, namely, a needle sampling position, a needle mixing position, and a needle spotting position; the needle sampling position, the needle mixing position, and the needle spotting position are on the same straight line and are different from each other.

[0032] Furthermore, the incubation tray includes at least two workstations, namely a tray mixing position and a tray sampling position, wherein the tray mixing position corresponds to the needle mixing position, and when one of the positions in the incubation tray moves to the tray sampling position, the sampling hole of the reagent card loaded in the position is located directly below the needle sampling position; the tray sampling position corresponds to the needle sampling position, and when one of the positions in the incubation tray moves to the tray mixing position, the mixing pool of the reagent card loaded in the position is located directly below the needle mixing position.

[0033] The utility model also provides an analyzer, comprising the above-mentioned immunochromatographic reagent card detection system.

[0034] The beneficial effects of the utility model are:

[0035] The immunochromatographic reagent card of the utility model is provided with a mixing pool and a reagent restraining structure in the mixing pool, so that a liquid fluorescent reagent can be dripped into the reagent restraining structure, and the surface tension of the liquid reagent is utilized to restrain the liquid reagent in the reagent restraining structure to limit the position of the liquid reagent; then, the liquid reagent restrained in the reagent restraining structure is transformed into a solid state by drying or freeze-drying, so that the obtained solid reagent is directly stored in the reagent restraining structure; during the mixing operation, the diluent and the sample liquid can be added into the mixing pool respectively, and then the diluent, the sample liquid and the solid reagent are mixed; or the diluent and the sample liquid can be mixed first and then added into the mixing pool to be mixed with the solid reagent; in this way, the mixing operation of the diluent, the sample liquid and the solid fluorescent reagent can be realized.

[0036] The utility model also has the following technical effects:

[0037] 1) The reagent restraining structure is set as an enclosure structure with an opening on one side, and the inner side surface of the enclosure is set as at least one curved surface or at least two adjacent platforms. Through the setting of this enclosure structure, the fluidity of the liquid fluorescent reagent can be effectively reduced, and the liquid fluorescent reagent can be restrained in the enclosure structure, thereby obtaining a solid reagent. At the same time, this enclosure structure can improve the mixing effect between the sample and the solid reagent during the mixing process. During the mixing process, the liquid outlet of the sampling needle is aligned with the opening, and the impact force of the liquid discharged from the sampling needle can be used to form an impact effect on the solid reagent stored in the reagent restraining structure, and the guiding effect of the enclosure cloth on the liquid can be used to form a vortex in the enclosure cloth. After the combination of the two, the mixing efficiency between the liquid to be mixed and the solid reagent can be effectively improved.

[0038] 2) By respectively setting the first inclined plane and the second inclined plane on the two opposite sides of the bottom surface of the pool, and limiting the angle between the first inclined plane and the horizontal plane and between the second inclined plane and the horizontal plane, in particular, limiting the angle between the normal of the tangent plane at any point on the area corresponding to the reagent constraint structure on the first inclined plane and the normal of the horizontal plane to be between 10°-60°, and less than the angle between the normal of the tangent plane at any point on the second inclined plane and the normal of the horizontal plane, in this way, during the mixing operation, when the sampling needle sucks and spits, a tidal wave can be formed in the mixing pool, and the tidal wave formed on the first inclined plane is larger, and the tidal wave can be used to speed up the mixing efficiency of the liquid to be mixed and the solid reagent. Among them, the angle α is 10°-60°. If the angle is too large, the mixing effect will also be weakened. At the same time, too large an angle will also make it easy for the liquid fluorescent reagent to flow away from the first inclined plane, making it difficult to constrain and fix the liquid fluorescent reagent at a specific position in the mixing pool. On the contrary, too small an angle will also reduce the mixing effect, so the angle α is 10°-60°. According to experimental verification, the preferred angle is 15°-45°, and the most preferred angle is 18°-30°.

[0039] The “liquid to be tested” mentioned herein may also be a separate sample liquid, or a diluted sample liquid obtained by mixing a diluent with the sample liquid, or a combination of a separate sample liquid and a separate diluent. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] In order to make the purpose, technical solution and beneficial effects of the utility model clearer, the utility model is described with the following drawings:

[0041] Figure 1 It is a schematic diagram of the structure of the first solution of the sample analysis system of the present invention; specifically, it is a schematic diagram of the structure when the sample spotting hole is located on the radially inward side of the mixing pool;

[0042] Figure 2 It is a schematic diagram of the structure of the second solution of the sample analysis system of the present invention; specifically, it is a schematic diagram of the structure when the sample spotting hole is located on the radially inward side of the mixing pool;

[0043] Figure 3 It is a schematic diagram of the structure of the third solution of the sample analysis system of the present invention; specifically, it is a schematic diagram of the structure when the mixing pool is located on the radially inward side of the spotting hole;

[0044] Figure 4 Schematic diagram of the structure of the reagent card;

[0045] Figure 5 It is a cross-sectional view of the mixing tank;

[0046] Figure 6 A top view of the mixing tank.

[0047] Description of reference numerals:

[0048] 100-reagent card; 110-upper card shell; 111-sample spot hole; 112-observation window; 120-lower card shell; 121-mixing pool; 122-enclosing structure; 1221-enclosing part; 1222-opening part; 123-pool bottom surface; 124-first inclined plane; 125-second inclined plane; 126-top frame; 126a-first semicircular arc segment; 126b-second semicircular arc segment; 127-transition inclined plane; 128-liquid outlet direction; 130-test strip;

[0049] 200-turntable; 201-card position; 202-card loading position; 203-card unloading position; 204-disc mixing position; 205-inventory sampling position;

[0050] 300-sampling needle; 301-liquid outlet; 302-needle tip; 303-moving path; 304-needle sampling position; 305-needle mixing position; 306-needle spotting position; 307-needle dilution position. DETAILED DESCRIPTION

[0051] The present invention will be further described below in conjunction with the accompanying drawings and specific embodiments so that those skilled in the art can better understand the present invention and implement it, but the embodiments are not intended to limit the present invention.

[0052] like Figure 1-3 As shown, the immunochromatographic reagent card detection system of this embodiment includes an incubation tray assembly, a sampling needle assembly, a detection device and a reagent card 100. The incubation tray assembly includes an incubation tray 200 and a rotation drive assembly for driving the incubation tray 200 to rotate. The incubation tray 200 is provided with a plurality of clamping positions 201 for loading reagent cards. Specifically, the clamping positions 201 are evenly distributed in an annular manner on the incubation tray 200, such as Figure 1-2 As shown, 18 snap-in positions 201 are evenly distributed in a ring on the incubation tray 200, and the angle between two adjacent snap-in positions 201 is 20°. Figure 3 As shown, 9 clamping positions 201 are evenly distributed in a ring on the incubation tray 200, and the angle between two adjacent clamping positions 201 is 40°. Specifically, the incubation tray assembly also includes a clamping position 202 and an unloading position 201. A clamping assembly is provided at a position corresponding to the clamping position 202, which is used to load the reagent card 100 into the clamping position 201. A unloading assembly is provided at a position corresponding to the unloading position 201, which is used to unload the reagent card 100 that has completed the test from the clamping position 201.

[0053] The sampling needle assembly includes a sampling needle 300 and a sampling needle driving assembly that drives the sampling needle 300 to move in a straight line, that is, in this embodiment, the sampling needle driving assembly is a linear driving assembly, and the moving path 303 of the sampling needle 300 is a straight line. At least three working positions are provided on the moving path of the sampling needle 300, namely, a needle sampling position 304, a needle mixing position 305, and a needle spotting position 306. In some other embodiments, a needle dilution position 307 can also be provided on the moving path 303 of the sampling needle 300. The sampling needle 300 can absorb reagents such as sample liquid and diluent at the needle sampling position 304; the sampling needle 300 can perform mixing operations by suction and exhalation at the needle mixing position 305; and the sampling needle 300 can perform spotting operations at the needle spotting position 306. In some other embodiments, a needle dilution position 307 may be set on the moving path 303 of the sampling needle 300, and the sampling needle 300 may perform a dilution operation at the needle dilution position 307, that is, the sample liquid and the diluent may be mixed in the needle dilution position 307 to dilute the sample liquid.

[0054] like Figure 4As shown, the reagent card 100 is provided with a mixing pool 121 and a spotting hole 111 at intervals. In this embodiment, the vertical projections of the needle spotting position 306 and the needle mixing position 305 are located inside the incubation tray 200, and the vertical projections of the needle sampling position 304 and the needle dilution position 307 are located outside the incubation tray 200. The incubation tray assembly of this embodiment corresponds to the needle spotting position 306 and the needle mixing position 305, respectively, and is provided with an inventory spotting position 205 and a tray mixing position 204. Specifically, when one of the card positions 201 in the incubation tray 200 moves to the inventory spotting position 205, the spotting hole 111 of the reagent card 100 loaded in the card position 201 is located directly below the needle spotting position 306, so that after driving the sampling needle 300 to move to the needle spotting position 306 along the moving path 303, the sampling needle 300 is driven to move downward and extend into the spotting hole 111, and the sampling needle 300 can be used for spotting. When one of the slots 201 in the incubation disk 200 moves to the disk mixing position 204, the mixing pool 121 of the reagent card 100 loaded in the slot 201 is located directly below the needle mixing position 305. In this way, after driving the sampling needle 300 to move to the needle mixing position 305 along the moving path 303, the sampling needle 300 is driven to move downward and extend into the mixing pool 121, and the sampling needle 300 can be used for mixing operations.

[0055] In this embodiment, when one of the positions 201 in the incubation disk 200 moves to the disk mixing position 204, the mixing pool 121 of the reagent card 100 loaded in the position 201 is located directly below the needle mixing position 305, and the angle between the long axis of the reagent card mixing pool 121 and the liquid outlet direction 128 of the sampling needle 300 and the moving path 303 of the sampling needle 300 satisfies:

[0056]

[0057] in, is the angle between the long axis of the mixing pool 121 of the reagent card 100 and the moving path 303 of the sampling needle 300; is the angle between the liquid outlet direction 128 of the sampling needle 300 and the moving path 303 of the sampling needle 300; is the allowable angle error. In this embodiment, In this embodiment, the liquid outlet direction 128 of the sampling needle 300 is perpendicular to the moving path 303 of the sampling needle 300, that is, The value is 90°.

[0058] In this way, during the mixing operation, the liquid outlet direction 128 of the sampling needle 300 can be made parallel or nearly parallel to the long axis of the mixing pool 121. On the one hand, the liquid can be prevented from splashing out of the mixing pool 121. On the other hand, the suction and exhalation of the sampling needle 300 can be used to form a larger tidal wave in the mixing pool 121 to improve the mixing efficiency. In this embodiment, a solid reagent is provided in the mixing pool 121, and when the sampling needle 300 injects liquid or suction and exhales to mix in the mixing pool 121 of the reagent card 100 located at the disk mixing position 204 at the needle mixing position 305, the liquid outlet of the sampling needle 300 faces the solid reagent. In this way, on the one hand, the tidal wave can be used to improve the flushing effect on the solid reagent and improve the mixing efficiency; on the other hand, the liquid outlet flow of the sampling needle 300 can directly impact the solid reagent, further improving the mixing efficiency of the solid reagent. In this embodiment, the solid reagent is a solid fluorescent reagent.

[0059] Specifically, when the reagent card 100 is loaded in the card position 201, the spotting hole 111 can be located on the side of the mixing pool 121 facing radially inward; or the mixing pool 121 can be located on the side of the spotting hole 11 facing radially inward. The spotting hole 111 can be a circular hole or a long hole with a long axis. The long hole has various structural forms, such as an elliptical hole, a round hole, a rectangular hole with rounded corners, etc., which will not be repeated. Specifically, when the spotting hole 11 is a long hole with a long axis, in order to ensure that the liquid outlet direction 128 of the sampling needle 300 is parallel or nearly parallel to the long axis of the spotting hole 111 during the spotting operation, the angle δ between the long axis of the mixing pool 121 of this embodiment and the long axis of the spotting hole 111 satisfies:

[0060]

[0061] Among them, when the sample spotting hole 111 is located on the side of the mixing pool 121 facing radially inward, D1 is the distance between the sample spotting hole 111 and the center of the incubation plate 200; when the mixing pool 121 is located on the side of the sample spotting hole 111 facing radially inward, D1 is the distance between the mixing pool 121 and the center of the incubation plate 200; D2 is the distance between the mixing pool 121 and the sample spotting hole 111; D3 is the distance between the needle sample spotting position 306 and the needle mixing position 305; Δδ is the allowable angle error. According to experimental verification, the allowable angle error Δδ is generally less than or equal to 15°, preferably, Δδ is less than or equal to 10°. That is, the angle δ between the long axis of the mixing pool 121 and the long axis of the sample spotting hole 111 is equal to the angle θ between the needle sample spotting position 306 and the needle mixing position 305 compared to the center of the incubation plate 200.

[0062] In particular, the liquid discharge direction 128 of the sampling needle 300 is perpendicular to the moving path 303 of the sampling needle 300, and when one of the positions 201 of the incubation plate 200 moves to the plate spotting position 205 or the plate mixing position 204, the central axis of the position 201 is perpendicular to the moving path 303 of the sampling needle 300, then the angle δ between the long axis of the mixing pool 121 and the long axis of the spotting hole 111 satisfies:

[0063]

[0064] Specifically, Figure 1-2 As shown, when one of the positions 201 of the incubation tray 200 moves to the sample counting position 205, the central axis of the position 201 is perpendicular to the moving path 303 of the sampling needle 300; Figure 3 As shown, when one of the positions 201 of the incubation tray 200 moves to the tray mixing position 204 , the central axis of the position 201 is perpendicular to the moving path 303 of the sampling needle 300 .

[0065] Of course, when the sample spotting hole 111 is a long hole with a long axis, when one of the card positions 201 in the incubation plate 200 moves to the sample spotting position 205, the angle between the long axis of the sample spotting hole 111 of the reagent card 100 and the liquid outlet direction 128 of the sampling needle 300 and the moving path 303 of the sampling needle should also satisfy:

[0066]

[0067] in, is the angle between the long axis of the sample spot hole 111 of the reagent card 100 and the moving path of the sampling needle 300; is the allowable angle error. In this embodiment, In this way, leakage of the liquid to be tested can be prevented.

[0068] like Figure 4As shown, the present embodiment also proposes an immunochromatography reagent card (hereinafter referred to as "reagent card"), including an upper card shell 110, a lower card shell 120 and a test strip 130, the upper card shell 110 covers the lower card shell 120, the test strip 130 is located between the upper card shell 110 and the lower card shell 120, and a mixing pool 121 is provided on the upper card shell 110 or the lower card shell 120. In the present embodiment, the mixing pool 121 is arranged on the lower card shell 120, which can effectively reduce the thickness of the reagent card 100. Of course, in some other embodiments, the mixing pool 121 can also be arranged on the upper card shell 110, which can also meet the use requirements. In the present embodiment, a reagent constraint structure is provided in the mixing pool 121, and the reagent constraint structure is at least used to utilize the surface tension effect to constrain the liquid reagent before the mixing operation and store the solid reagent obtained after the liquid reagent is dried or freeze-dried. In this embodiment, one end of the lower chuck 120 extends to the outside of the upper chuck 110 along the direction of its axis, and the mixing pool 129 is arranged in the area where the lower chuck 120 is exposed from the upper chuck 110, so that the mixing pool 121 and the test strip 130 can be staggered. Of course, in some other embodiments, the mixing pool 121 can be located outside one end of the test strip 130, so that the upper chuck 110 covers the test strip 130 and the mixing pool 121; at this time, the spot hole 111 is arranged on the upper chuck 110 corresponding to the test strip 130, and the mixing hole is also arranged on the upper chuck 110 corresponding to the mixing pool 121, and the sampling needle 300 can inject the liquid to be mixed into the mixing pool 121 and absorb the liquid to be tested obtained after mixing through the mixing hole. In this embodiment, an observation window 112 is arranged on the upper chuck 110 corresponding to the test strip 300, and the mixing pool 121, the spot hole 111 and the observation window 112 are arranged independently and spaced from each other. The observation window 112 may be disposed between the mixing pool 121 and the sample spotting hole 111 ; of course, the sample spotting hole 111 may also be disposed between the mixing pool 121 and the observation window 112 .

[0069] Specifically, the reagent restraining structure is a rough structure and / or an enclosure structure 122. The rough structure can be a rough surface set in the mixing tank 121, etc., which increases the contact area with the liquid reagent by using the rough surface, so that the surface tension of the liquid reagent can be used to better restrain the range of the liquid reagent, so that the liquid reagent is restrained in the reagent restraining structure. In this embodiment, the reagent restraining structure is preferably an enclosure structure 122. Figure 5-6As shown, the enclosure structure has an enclosure portion 1221 and an opening portion 1222. The enclosure portion 1221 is used to constrain the liquid reagent by surface tension before the mixing operation and store the solid reagent obtained after the liquid reagent is dried or freeze-dried, and the opening portion 1222 is used for the reagent discharged from the sampling needle 300 to flow in and mix with the solid reagent. Specifically, further, the width b of the opening portion 1222 is less than or equal to 5mm; preferably, the width b of the opening portion 1222 is less than or equal to 3.5mm; further preferably, the width b of the opening portion 1222 is less than or equal to 2.5mm. The inner side surface and bottom surface of the enclosure structure 122 can be set to a rough structure to further enhance the restraining effect on the liquid reagent. Specifically, the inner side surface of the enclosure 1221 includes at least one curved surface or at least two adjacent planes. In this way, the horizontal cross-sectional profile of the inner side surface of the enclosure 1221 can be a variety of shapes such as U-shaped, V-shaped, circular arc-shaped or elliptical arc-shaped. The inner side surface of the enclosure 1221 is used to guide and constrain the reagent discharged from the sampling needle 300, so that a vortex can be formed in the enclosure 1221, further improving the mixing efficiency of the solid reagent. In this embodiment, the horizontal cross-sectional profile of the inner side surface of the enclosure 1221 can be U-shaped, and the liquid discharge direction 128 of the sampling needle 300 deviates from the center line of the enclosure 1221. In this way, the angle between the liquid discharge direction 128 of the sampling needle 300 and the tangential direction of the contact point of the inner side surface of the enclosure 1221 can be an acute angle, so that the reagent discharged from the sampling needle 300 has a tangential component velocity after contacting and rebounding with the inner side surface of the enclosure structure, and the tangential component velocity is used to form a vortex in the enclosure 1221. Similarly, the V-shaped, circular arc-shaped or elliptical arc-shaped enclosure 1221 can also make the liquid form a vortex therein, and the principle is the same and will not be repeated. Specifically, in this embodiment, the enclosure structure 122 has a central axis, and the central axis of the enclosure structure is coaxial with the central axis of the mixing tank 121.

[0070] In order to make the liquid flow when the sampling needle 300 discharges the reagent have an impact on the solid reagent, the reagent restraint structure of this embodiment is arranged in the non-bottom area of ​​the mixing pool 121, such as Figure 5-6As shown. Specifically, a pool bottom surface 123 is provided in the mixing pool 121, and a first inclined surface 124 is provided on one side of the pool bottom surface 123, and the reagent restraint structure is arranged on the first inclined surface 124. Specifically, the first inclined surface 124 can be a plane or a curved surface. In particular, if the inclination angle of the first inclined surface 124 relative to the horizontal plane is too small, the volume at the bottom of the mixing pool 121 will be increased, resulting in a large amount of required sample liquid, diluent and solid reagent, and a large amount of residual liquid to be tested, which is not conducive to the mixing of solid reagents during the suction and exhalation process; if the inclination angle of the first inclined surface 124 relative to the horizontal plane is too large, the fluidity of the liquid reagent on the first inclined surface 124 will be increased, resulting in the difficulty of the reagent restraint structure to restrain the liquid reagent through surface tension, and then the solid reagent obtained after the liquid reagent is dried or freeze-dried cannot be stored in the reagent restraint structure. In this embodiment, the angle α between the normal of the tangent plane at any point of the first inclined plane 124 and the normal of the horizontal plane is 10°-60°; preferably, the angle α satisfies: 15°≤α≤45°; further preferably, the angle α satisfies: 18°≤α≤30°; more preferably, the angle α satisfies: 20°≤α≤25°. In a specific embodiment, the first inclined plane 124 is a curved surface, and only a small part of the first inclined plane 124 can satisfy that the angle between the normal of the tangent plane at any point in the area and the normal of the horizontal plane is within the range of the angle α, such as: the angle between the normal of the tangent plane at any point on the central axis of the first inclined plane and the normal of the horizontal plane is equal to after the direction is changed. Figure 5 α shown in ; or as: when the first slope 124 is a curved surface, there is at least one first sub-region on the first slope 124, and the angle between the normal of the tangent plane at any point in the first sub-region and the normal of the horizontal plane satisfies the range of angle α; it can also be: the angle between the normal of the tangent plane at any point in the region corresponding to the reagent confinement structure on the first slope 124 and the normal of the horizontal plane is within the range of angle α.

[0071] The second inclined surface 125 is provided on the other side of the pool bottom surface 123 of this embodiment opposite to the first inclined surface 124. Specifically, the second inclined surface 125 can be a plane or a curved surface. In particular, if the angle between the second inclined surface and the horizontal plane is too small, it is also easy to increase the bottom volume of the mixing pool 121, resulting in a large amount of sample liquid, diluent and solid reagent required, and a large amount of residual liquid to be tested, which is not conducive to the mixing of solid reagents during suction and exhalation. Therefore, in this embodiment, the angle between the second inclined surface 125 and the horizontal plane is set to be greater than the angle between the first inclined surface 124 and the horizontal plane. Specifically, the angle β between the normal of the tangent plane at any point of the second inclined surface and the normal of the horizontal plane satisfies: 45°≤β≤90°; preferably, the angle β satisfies: 60°≤β≤85°. In a specific embodiment, the second inclined surface 125 is a curved surface, and only a small area on the second inclined surface 125 may satisfy that the angle between the normal of the tangent plane at any point in the area and the normal of the horizontal plane is within the range of the angle β, such as: the angle between the normal of the tangent plane at any point on the central axis of the second inclined surface and the normal of the horizontal plane is equal to after the direction is changed Figure 5 β shown in ; or as follows: when the second inclined surface 125 is a curved surface, there is at least one second sub-region on the second inclined surface, and the angle between the normal of the tangent plane and the normal of the horizontal plane at any point in the second sub-region satisfies the range of the angle β. With this arrangement, during the mixing operation, when the sampling needle 300 sucks and exhales, a tidal wave can be formed in the mixing tank 121, and the tidal wave range formed on the first inclined surface 124 is larger, and the tidal wave can be used to accelerate the mixing efficiency of the liquid to be mixed and the solid reagent.

[0072] Specifically, the pool bottom surface 123 can be oval, circular, oval, square or rounded square. In this embodiment, the pool bottom surface 123 is circular. In order to control the bottom volume of the mixing pool 121, the size of the pool bottom surface 123 should be limited. In this embodiment, the radius r1 of the pool bottom surface 123 satisfies: 2mm≤r1≤10mm; preferably, the radius r1 of the pool bottom surface 123 satisfies: 3mm≤r1≤6mm. This ensures that the pool bottom surface 123 can not only meet the requirements of the sampling needle 300 to suck and discharge liquid, but also can easily limit the bottom of the mixing pool 121 to a suitable range.

[0073] Specifically, in this embodiment, a top frame 126 is provided on the top of the mixing pool 121, and the horizontal cross-sectional profile of the top frame 126 is oval, circular, elliptical, square or rounded square. The horizontal cross-sectional profile of the top frame 126 of this embodiment is oval, and the top frame 126 includes a first semicircular arc segment 126a and a second semicircular arc segment 126b that are arranged opposite to each other; the projections of the center of the pool bottom surface 123 and the center of the first semicircular arc segment 126a and the center of the second semicircular arc segment 126b on the horizontal plane are located on the same straight line, and the first distance L1 between the center of the pool bottom surface 123 and the center of the first semicircular arc segment 126a is greater than the second distance L2 between the center of the pool bottom surface 123 and the center of the second semicircular arc segment 126b. In this embodiment, the projection of the center of the pool bottom surface 123 and the center of the second semicircular arc segment 126b on the horizontal plane coincides, that is, the first distance L2 between the center of the pool bottom surface 123 and the center of the second semicircular arc segment 126b is 0. A transition slope 127 is provided between the top frame 126 and the pool bottom surface 123. Specifically, the transition slope between the pool bottom surface 123 and the first semicircular arc segment 126a forms a first slope 124, and the transition slope between the pool bottom surface 123 and the second semicircular arc segment 126b forms a second slope 125, that is, in this embodiment, the first slope 124 and the second slope 125 are both curved surfaces, and the slope of the first slope 124 relative to the horizontal plane is less than the slope of the second slope 125 relative to the horizontal plane. In this embodiment, the radius of the first semicircular arc segment 126a and the second semicircular arc segment 126b is r2, and r2≥r1, preferably r2 is greater than r1. In this embodiment, the center of the pool bottom surface 123 and the center of the second semicircular arc segment 126b are located on the same vertical line.

[0074] In this embodiment, the minimum distance c between the reagent restraint structure and the pool bottom surface 123 in the vertical direction is greater than or equal to the distance between the liquid outlet 301 of the sampling needle 300 and the needle tip 302. In this way, even if the sampling needle 300 does not touch the bottom, the liquid sprayed from the liquid outlet 301 of the sampling needle 300 can contact the lowest point of the reagent restraint structure, thereby avoiding the problem of low mixing efficiency of the solid reagent located at a lower position of the reagent restraint structure.

[0075] This embodiment also proposes an analyzer including the above-mentioned immunochromatographic reagent card detection system.

[0076] The above-described embodiments are only preferred embodiments for fully illustrating the present utility model, and the protection scope of the present utility model is not limited thereto. Equivalent substitutions or changes made by technicians in the technical field on the basis of the present utility model are all within the protection scope of the present utility model. The protection scope of the present utility model shall be subject to the claims.

Claims

1. An immunochromatographic reagent card, comprising an upper card shell, a lower card shell and a test strip, wherein the upper card shell is covered on the lower card shell, and the test strip is located between the upper card shell and the lower card shell, characterized in that: A mixing pool is provided on the upper card shell or the lower card shell, a reagent restraining structure is provided in the mixing pool, and a solid reagent is restrained in the reagent restraining structure.

2. The immunochromatographic reagent card according to claim 1, characterized in that: The reagent restraint structure is at least used to restrain the liquid reagent by surface tension before the mixing operation and store the solid reagent obtained after the liquid reagent is dried or freeze-dried. The reagent restraint structure is a rough structure and / or an enclosure structure.

3. The immunochromatographic reagent card according to claim 2, characterized in that: The reagent restraining structure is an enclosure structure, which has an enclosure portion and an opening portion. The enclosure portion is used to restrain the liquid reagent by surface tension before the mixing operation and store the solid reagent obtained after the liquid reagent is dried or freeze-dried, and the opening portion is used for the reagent discharged from the sampling needle to flow in and mix with the solid reagent.

4. The immunochromatographic reagent card according to claim 3, characterized in that: The inner side surface of the enclosure portion includes at least one curved surface or at least two adjacent flat surfaces.

5. The immunochromatographic reagent card according to claim 3, characterized in that: The horizontal cross-sectional profile of the inner side surface of the enclosure portion is U-shaped, V-shaped, circular arc-shaped or elliptical arc-shaped.

6. The immunochromatographic reagent card according to claim 3, characterized in that: The width of the opening is less than or equal to 5 mm.

7. The immunochromatographic reagent card according to claim 6, characterized in that: The width of the opening is less than or equal to 3.5 mm.

8. The immunochromatographic reagent card according to any one of claims 1 to 7, characterized in that: The reagent restraint structure is arranged in the non-bottom area of ​​the mixing tank.

9. The immunochromatographic reagent card according to claim 8, characterized in that: A pool bottom surface is provided in the mixing pool, a first inclined surface is provided on one side of the pool bottom surface, and at least a part of the reagent restraint structure is arranged on the first inclined surface.

10. The immunochromatographic reagent card according to claim 9, characterized in that: The first inclined surface is a plane or a curved surface. There is at least one point A on the first inclined surface, and an angle α between a normal line of the tangent plane at the point A and a normal line of the horizontal plane is 10°-60°.

11. The immunochromatographic reagent card according to claim 10, characterized in that: The angle α is 15°-45°.

12. The immunochromatographic reagent card according to claim 11, characterized in that: The angle α is 18°-30°.

13. The immunochromatographic reagent card according to claim 10, characterized in that: A second inclined surface is provided on the other side of the pool bottom opposite to the first inclined surface. The second inclined surface is a plane or a curved surface. There is at least one point B on the second inclined surface. The angle between the normal of the tangent plane at the point B and the normal of the horizontal plane is β. The angle β is 45°≤β≤90°, and the angle β is greater than the angle α.

14. The immunochromatographic reagent card according to claim 13, characterized in that: The included angle β is 60°≤β≤85°.

15. The immunochromatographic reagent card according to claim 13, characterized in that: When the first inclined surface is a curved surface, there is at least one first sub-region on the first inclined surface, and the angle between the normal of the tangent plane and the normal of the horizontal plane at any point in the first sub-region satisfies the range of angle α; and / or, when the second inclined surface is a curved surface, there is at least one second sub-region on the second inclined surface, and the angle between the normal of the tangent plane and the normal of the horizontal plane at any point in the second sub-region satisfies the range of angle β.

16. The immunochromatographic reagent card according to claim 9, characterized in that: The bottom surface of the pool is oval, circular, elliptical, square or rounded square, and the top of the mixing pool is provided with a top frame, and the horizontal cross-sectional profile of the top frame is oval, circular, elliptical, square or rounded square.

17. The immunochromatographic reagent card according to claim 16, characterized in that: The bottom surface of the pool is circular with a radius of r1, the horizontal cross-sectional profile of the top frame is an oval circle, and the top frame includes a first semicircular arc segment and a second semicircular arc segment that are arranged opposite to each other; the center of the bottom surface of the pool and the projections of the center of the first semicircular arc segment and the center of the second semicircular arc segment on the horizontal plane are located on the same straight line, and the first distance L1 between the center of the bottom surface of the pool and the center of the first semicircular arc segment is smaller than the second distance L2 between the center of the bottom surface of the pool and the center of the second semicircular arc segment; The transition slope between the pool bottom and the first semicircular arc segment forms the first slope; a second slope is provided on the other side of the pool bottom opposite to the first slope, and the transition slope between the top frame and the second semicircular arc segment forms the second slope.

18. The immunochromatographic reagent card according to claim 17, characterized in that: The radii of the first semicircular arc segment and the second semicircular arc segment are r2, and r2≥r1.

19. The immunochromatographic reagent card according to claim 18, characterized in that: r2 is greater than r1, and r1 is between 2-10mm.

20. The immunochromatographic reagent card according to claim 17, characterized in that: r1 is between 3-6mm.

21. The immunochromatographic reagent card according to claim 1, characterized in that: The minimum distance c between the reagent restraining structure and the bottom surface of the pool in the vertical direction is greater than or equal to the distance between the liquid outlet and the needle tip of the sampling needle.

22. The immunochromatographic reagent card according to any one of claims 1 to 7, characterized in that: The upper card shell is provided with a spot hole corresponding to the test strip, and the spot hole is a round hole or a long hole with a long axis; and when the spot hole is a long hole, the angle between the long axis of the mixing pool and the long axis of the spot hole is satisfy: Wherein, when the spotting hole is located on the radially inward side of the mixing pool, is the distance between the spot hole and the center of the incubation plate; when the mixing pool is located on the radially inward side of the spot hole, is the distance between the mixing pool and the center of the incubation plate; is the distance between the mixing pool and the spotting well; is the distance between the needle sampling position and the needle mixing position; is the allowable angular error.

23. The immunochromatographic reagent card according to claim 22, characterized in that: An observation window is arranged on the upper card shell corresponding to the test strip, and the mixing pool, the spotting hole and the observation window are arranged independently and spaced from each other.

24. The immunochromatographic reagent card according to claim 23, characterized in that: The observation window is arranged between the mixing pool and the sample spotting hole; or the sample spotting hole is arranged between the mixing pool and the observation window.

25. An immunochromatographic reagent card detection system, characterized in that: It comprises a sampling needle assembly, an incubation disk assembly, a detection device and an immunochromatography reagent card as described in any one of claims 1 to 24.

26. An immunochromatographic reagent card detection system as claimed in claim 25, characterized in that: The sampling needle comprises at least three working positions: a needle sampling position, a needle mixing position, and a needle spotting position; the needle sampling position, the needle mixing position, and the needle spotting position are on the same straight line and are different from each other.

27. An immunochromatographic reagent card detection system as claimed in claim 25 or 26, characterized in that: The incubation tray comprises at least two workstations, namely a tray mixing position and a tray sampling position, wherein the tray mixing position corresponds to the needle mixing position, and when one of the positions in the incubation tray moves to the tray sampling position, the sampling hole of the reagent card loaded in the position is located directly below the needle sampling position; the tray sampling position corresponds to the needle sampling position, and when one of the positions in the incubation tray moves to the tray mixing position, the mixing pool of the reagent card loaded in the position is located directly below the needle mixing position.

28. An analyzer, characterized in that: Comprising the immunochromatographic reagent card detection system as described in any one of claims 25-27.

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