Blood routine examination and immunity combined detection kit

Abstract

The utility model relates to a blood routine examination and immunity combined detection kit. The kit comprises a glass slide; the immunodetection test paper is arranged on the glass slide; the glass slide cover plate is provided with a blood routine examination structure and is arranged on the glass slide at an interval relative to the immunodetection test paper; the double-sided adhesive tape is provided with a partition window for partitioning the glass slide cover plate and is used for adhering the glass slide cover plate to the glass slide, so that a detection cavity taking the partition window as a boundary is formed between the glass slide cover plate and the glass slide; the reaction material layer is formed in the detection cavity; and the kit cover plate is covered on the glass slide.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a combined blood routine and immune detection kit. Background Technology

[0002] A complete blood count (CBC) can be performed by drawing blood from either the vein or the capillaries. Adults and the elderly typically have venous blood drawn, while newborns and children often have capillaries drawn because venous blood is difficult to obtain. After blood is drawn, an anticoagulant is routinely added to prevent blood cell aggregation. The blood is then tested using a CBC kit to determine the number of white blood cells, red blood cells, and platelets, as well as the proportions of neutrophils, lymphocytes, and monocytes within the white blood cell count. Red blood cell volume can also be measured. Colloidal gold is a commonly used labeling technique. Immunogold assays use colloidal gold as a tracer marker in antigen-antibody labeling, offering unique advantages.

[0003] In existing technologies, routine blood tests are generally performed using routine blood test kits, while immunochromatographic gold assays are performed using immunoassay strips. This results in increased costs of consumables and no improvement in testing efficiency. Utility Model Content

[0004] This application provides a combined blood routine and immunological detection kit to solve the above-mentioned technical problems.

[0005] In a first aspect, this application provides a combined blood routine and immunoassay kit, comprising:

[0006] glass slide;

[0007] An immunoassay test strip is placed on the glass slide;

[0008] A glass slide cover plate, equipped with a blood routine test structure, is positioned on the glass slide at an interval relative to the immunoassay test strip;

[0009] Double-sided adhesive tape with partition windows for dividing the glass slide cover plate into sections, used to adhere the glass slide cover plate to the glass slide, so that a detection cavity is formed between the glass slide cover plate and the glass slide with the partition windows as the boundary;

[0010] A reactive material layer is formed within the detection cavity;

[0011] The reagent kit cover is placed on the glass slide.

[0012] Preferably, the immunoassay test strip has a fixing bracket at the bottom, which is attached to the glass slide by the double-sided adhesive.

[0013] Preferably, the reagent kit cover is provided with a slide cover clearance groove corresponding to the position of the slide cover.

[0014] Preferably, the blood routine test structure of the slide cover includes: a first functional area disposed at one end of the slide cover; the partition window on the double-sided adhesive includes a first window disposed corresponding to the first functional area; the first functional area includes: a first drip hole, a first detection area and a first vent groove disposed sequentially from the first end of the slide cover.

[0015] Preferably, the blood routine test structure of the slide cover plate further includes a second functional area, the first functional area and the second functional area are arranged alternately, and the partition window on the double-sided adhesive includes a second window corresponding to the second functional area; the second functional area includes a second drop hole, a second detection area and a second vent groove arranged sequentially from the second end of the slide cover plate.

[0016] Preferably, the first dripping hole and / or the second dripping hole are provided with a boss that surrounds the opening.

[0017] Preferably, the glass cover plate is also provided with a scale.

[0018] Preferably, the immunoassay test strip is an immunochromatographic gold test strip or an immunofluorescence test strip.

[0019] Preferably, the immunoassay test strip has a sample application area, a detection area, and an absorbent paper area arranged sequentially along its length; the reagent kit cover has a sample application hole corresponding to the position of the sample application area and a viewing window corresponding to the position of the detection area.

[0020] Preferably, one end of the reagent kit cover is provided with a recessed groove, and the recessed groove is provided with anti-slip protrusions.

[0021] The technical solutions provided in this application have the following advantages compared with the prior art:

[0022] The blood routine and immunoassay combined detection kit provided in this application can simultaneously perform blood routine tests, immunochromatographic gold test strips, or immunofluorescence test strips (immunochromatographic gold test strips and immunofluorescence test strips are optional). That is, by changing the test strips, three or more tests can be performed. Furthermore, compared to existing detection methods, integrating two tests into one unit reduces shared costs compared to separate consumable structures, thus reducing consumable consumption costs during use. In addition, simultaneous detection allows for rapid material preparation, eliminating the need for separate material preparation for each test, and also eliminates the need for additional material preparation during testing, thereby improving efficiency.

[0023] Furthermore, the integrated consumable structure can reduce the overall product size and transportation costs. Attached Figure Description

[0024] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with the present invention and, together with the description, serve to explain the principles of the present invention.

[0025] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0026] One or more embodiments are illustrated by way of example with reference numerals in the accompanying drawings. These illustrations do not constitute a limitation on the embodiments. Elements with the same reference numerals in the drawings are denoted as similar elements. Unless otherwise stated, the figures in the drawings are not to be limited by scale.

[0027] Figure 1 This is a schematic diagram of the reagent kit structure provided in the embodiments of this application;

[0028] Figure 2 for Figure 1 Structural breakdown diagram;

[0029] Figure 3 This is a schematic diagram of the glass slide cover assembly structure provided in the embodiments of this application;

[0030] Figure 4 A cross-sectional view of the glass slide cover, double-sided adhesive, and glass slide assembly provided in the embodiments of this application;

[0031] Figure 5 A schematic diagram of the immunoassay test strip and its base structure provided in the embodiments of this application.

[0032] Explanation of reference numerals in the attached figures:

[0033] 1. Reagent kit cover plate; 2. Slide cover plate; 3. Immunoassay strip; 4. Reaction material layer; 5. Detection chamber;

[0034] 11. Cover plate clearance groove; 12. Sample dispensing hole; 13. Viewing window; 14. Recessed groove; 15. Anti-slip protrusion;

[0035] 201. Double-sided adhesive tape; 202. Glass slide; 203. First dropper hole; 204. First detection area; 205. First vent groove; 206. Second vent groove; 207. Second detection area; 208. Second dropper hole; 209. Boss; 2011. First window; 2012. Second window; 21. First functional area; 22. Second functional area; 27. Scale;

[0036] 301. Fixed bracket; 302. Sample application area; 303. Testing area; 304. Absorbent paper area; 3011. Limiting barrier; 3012. Limiting sidewall;

[0037] 41. First reactive material layer; 42. Second reactive material layer;

[0038] 51. First detection chamber; 52. Second detection chamber. Detailed Implementation

[0039] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0040] The following disclosure provides numerous different embodiments or examples for implementing various structures of the present invention. To simplify the disclosure, specific examples of components and arrangements are described below. These are merely examples and are not intended to limit the scope of the invention. Furthermore, reference numerals and / or letters may be repeated in different examples. Such repetition is for simplification and clarity and does not in itself indicate a relationship between the various embodiments and / or arrangements discussed.

[0041] For ease of description, spatial relative terms may be used in the text to describe the relative position or movement of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "front," "back," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure undergoes a positional flip, orientation change, or change of motion, these directional indications will change accordingly. For instance, an element described as "below other elements or features" or "below other elements or features" will subsequently be oriented "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.

[0042] To address the technical problems of expensive testing consumables and low testing efficiency in existing technologies, this application provides a combined blood routine and immunoassay kit, which can reduce the cost of testing consumables and improve testing efficiency to a certain extent.

[0043] Figure 1-4 The image shows a blood routine and immunoassay combined detection kit provided in an embodiment of this application, comprising: a glass slide 202, an immunoassay test strip 3, a glass slide cover plate 2, double-sided adhesive tape 201, and a kit cover plate 1.

[0044] Among them, the glass slide 202 is mainly used to hold cells or tissue sections during detection. Its structure is transparent glass or quartz. In this embodiment, a general standard part with a thickness of 1.1 mm, a length of 75 mm, and a width of 25 mm is selected. Using a standard part makes its price relatively lower, thus making it easier to control the cost of the reagent kit.

[0045] The immunoassay test strip 3 can be an immunochromatographic gold test strip or an immunofluorescence test strip. Its structure generally includes a sample application area 302, a detection area 303, and an absorbent paper area 304 arranged sequentially along its length. The sample application area 302 receives the applied sample, the detection area 303 generates a chemical reaction and displays the detection result, and the absorbent paper area 304 guides the flow of the sample. The immunoassay test strip 3 is placed on the glass slide 202.

[0046] The slide cover plate 2 is equipped with a blood routine test structure, the thickness of which is selected to be 0.5-1.2mm, and the material can be glass or other light-transmitting materials with good light transmittance.

[0047] Furthermore, by injecting a trace amount of reagent solution into the detection chamber and drying it, a reaction layer (not shown in the figure) is formed on the glass slide 1. This eliminates the need for pre-embedded liquid detection solution in the reagent kit of this embodiment, saving most of the space, simplifying the consumable structure, and reducing costs. Simultaneously, the absence of pre-embedded liquid eliminates the need for additional pipetting devices, tip removal devices, etc., reducing the cost of supporting equipment.

[0048] In other words, in this embodiment, the front-end reagent reaction process of the reagent kit is eliminated. This embodiment is only for single-person testing and will not affect the focal length and accuracy of electronic imaging.

[0049] The double-sided adhesive 201 is provided with partition windows to divide the slide cover plate 2, which are used to adhere the slide cover plate 2 to the glass slide 202. Based on the thickness of the double-sided adhesive 201 and the setting of the partition windows, a detection cavity 5 is formed between the slide cover plate 2 and the glass slide 202 with the partition windows as the boundary (see reference). Figure 4Simultaneously, double-sided adhesive 201 can also be used to bond the immunoassay test strip 3 to the glass slide 202, and also to bond the reagent kit cover plate 1 and the glass slide 202. The glass slide cover plate 2, the glass slide 202, and the double-sided adhesive 201 form a sample detection chamber 5 with a partitioned window as its boundary. Double-sided adhesive 201 is the material layer that bonds the glass slide cover plate 2 to the glass slide 202. To avoid affecting the detection, double-sided adhesive 201 should not contain any chemicals that could affect the detection process, such as oils, alkalis, or acids. Furthermore, the viscosity of double-sided adhesive 201 must ensure that, after bonding, the liquid within the sample detection chamber does not cross-contaminate during detection.

[0050] In this embodiment, combined with Figure 4 As shown, a reaction material layer 4 is also provided inside the detection chamber 5. The reaction material layer 4 is attached to the inner wall of the detection chamber 5 (on the glass slide 202) after a small amount of reagent solution is injected into the detection chamber 5, dried, and then used to realize the function of routine blood test. It is disposed on the glass slide 202 at intervals relative to the immunoassay test strip 3. Based on this, the structural chamber for routine blood test can be made very thin, similar to the immunoassay test strip 3, thus enabling integration with the immunoassay test strip 3 at a relatively thin thickness.

[0051] The reagent kit cover 1 is placed on the glass slide 202, forming a space with the glass slide 202 to accommodate the slide cover 2 and the immunoassay strip 3.

[0052] In this embodiment, as Figure 5 As shown, the immunoassay test strip 3 has a fixing bracket 301 at its bottom. The fixing bracket 301 is a rigid structure that allows for rapid assembly of the immunoassay test strip 3. Furthermore, for different immunoassay test strips 3, the fixing bracket 301 is attached to the glass slide 202 using double-sided adhesive 201. This fixing bracket 301 structure enhances the scalability of the test.

[0053] The fixed card holder 301 has limiting walls 3011 at both ends and limiting sidewalls 3012 on both sides. The limiting walls 3011, limiting sidewalls 3012 and the base plate of the fixed card holder 301 form a limiting space for the immunoassay test strip. Correspondingly, the corresponding position of the reagent kit cover plate 1 is also provided with a corresponding groove structure (not shown in the figure) to avoid the fixed card holder 301 and the immunoassay test strip 3.

[0054] As a specific implementation method, the fixed card holder has a length of 45-85mm, a width of 3.8-4.5mm, and a depth of 0.5-2mm, which is suitable for most immunoassay test strips on the market in terms of length and width. Correspondingly, the length of the immunoassay test strip 3 is also adapted to the length of the fixed card holder.

[0055] In this embodiment, the reagent kit cover plate 1 is provided with a slide cover plate clearance groove 11 at the position corresponding to the slide cover plate 2. The cover plate clearance groove 11 is used to avoid the structure of the slide cover plate 2, so as to realize operations such as dripping and observation.

[0056] In this embodiment, as Figure 3 and Figure 4 As shown, the blood routine test structure of the slide cover plate 2 includes: a first functional area 21 disposed at one end of the slide cover plate 2; the partitioned window on the double-sided adhesive 201 includes a first window 2011 corresponding to the first functional area 21, and a first detection cavity 51 is formed between the first functional area 21 of the slide cover plate 2 and the slide 202; the reaction material layer 4 includes a first reaction material layer 41 formed within the first detection cavity 51; the first functional area 21 includes, sequentially disposed from the first end of the slide cover plate 2: a first drop hole 203, a first detection area 204, and a first venting groove 205. Specifically, the first drop hole 203 is a drop hole for red blood cells and platelets, the first detection area 204 is a detection area for red blood cells and platelets, and the first venting groove 205 is a venting groove for red blood cells and platelets.

[0057] In this embodiment, as Figure 3 As shown, the blood routine test structure of the slide cover plate 2 also includes a second functional area 22. The first functional area 21 and the second functional area 22 are spaced apart. The partition window on the double-sided adhesive 201 includes a second window 2012 corresponding to the second functional area 22. At the same time, a second detection cavity 52 is formed between the second functional area 22 of the slide cover plate 2 and the slide 202. The reaction material layer 4 includes a second reaction material layer 42 formed in the second detection cavity 52. ​​The second functional area 22 includes a second drop hole 208, a second detection area 207, and a second venting groove 206 sequentially arranged from the second end of the slide cover plate 2. Specifically, the second drop hole 208 is a drop hole for white blood cells and HGB, the second detection area 207 is a detection area for white blood cells and HGB, and the second venting groove is a venting groove for white blood cells and HGB.

[0058] In this embodiment, the distribution of the dropper hole, detection area, and venting groove is not limited to the arrangement shown in the figure. The distribution of the first functional area 21 and the second functional area 22 can be controlled based on the main structure of the reagent kit. In this embodiment, the main structure of the reagent kit is rectangular. Therefore, the first functional area 21 and the second functional area 22 are arranged along the length of the main structure. If the main structure of the reagent kit is square or triangular, the first functional area 21 and the second functional area 22 can be arranged in a parallel or triangular manner.

[0059] Furthermore, to achieve 2-4 detection indicators, the number of detection zones should be at least more than 2. Of course, the number of detection zones can be set according to different needs. Correspondingly, the number of drip holes and venting grooves should be at least no less than the number of detection zones.

[0060] In this embodiment, the first functional area 21 and the second functional area 22 have two detection areas, which can realize the detection of four indicators: RBC, WBC, PLT and HGB.

[0061] As a further improvement, the first dripping hole 203 and / or the second dripping hole 208 are provided with a boss 209 arranged around the opening (see reference). Figure 4 As shown, this can increase the bearing space between the slide cover plate 2 and the slide 202, thereby avoiding the risk of liquid overflowing from the drip hole.

[0062] As a further improvement, the glass slide cover plate 2 is also provided with a scale 27, which can realize the calibration function of the detection position.

[0063] In this embodiment, as Figure 1 and 2 As shown, the immunoassay test strip 3 is spaced apart on one side of the slide cover plate 2, and is isolated from the detection functional area of ​​the slide cover plate 2 by double-sided tape 201. The reagent kit cover plate 1 has a sample dispensing hole 12 corresponding to the sample dispensing area 302, and a viewing window 13 corresponding to the detection area 303. The sample dispensing hole 12 has an flared structure, making the opening of the sample dispensing hole 12 larger, facilitating sample dispensing and preventing sample from being mistakenly dispensed into the area of ​​the slide cover plate 2. The viewing window 13 is positioned along the detection area 303, covering the color development bar area of ​​the detection area 303.

[0064] In this embodiment, a recessed groove 14 is provided at one end of the reagent kit cover 1, and an anti-slip protrusion 15 is provided in the recessed groove 14. The size of the recessed groove 14 corresponds to the size of a normal user's finger, so that it is easy for the testing personnel to hold during testing and to prevent slipping.

[0065] Based on the above embodiments, the process and principle of performing a routine blood test are as follows:

[0066] After the operator collects blood from the fingertip, it is mixed in a specific reagent bottle and then dripped into the first drop well 203 and the second drop well 208. The mixture is left to stand for 2 minutes to allow the sample to fully react with the reaction material layer 4. The sample is then placed in the instrument for imaging and testing. The blood routine imaging mechanism in the instrument scans the reaction material layer 4 in the first detection area 204 and the second detection area 207 to obtain blood routine indicators.

[0067] Based on the above embodiments, the process and principle of colloidal gold detection are as follows:

[0068] After the operator collects blood from the fingertip, it is mixed in a specific reagent bottle and then dripped into the sample well 12. The mixture is left to stand for 2 minutes to allow the sample to fully react with the detection area 303. The sample is then placed in the instrument for imaging and testing. The colloidal gold imaging mechanism in the instrument scans the 303 detection area to obtain the colloidal gold test strip index.

[0069] In the above embodiments, the descriptions of each embodiment have different focuses. For parts that are not described in detail in a certain embodiment, please refer to the relevant descriptions in other embodiments.

[0070] In the description of this application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0071] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this application, "multiple" means two or more, unless otherwise explicitly specified.

[0072] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0073] In this application, unless otherwise expressly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature being directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature being directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0074] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of this application. The illustrative expressions of the above terms in this specification should not be construed as necessarily referring to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. In addition, those skilled in the art can combine and integrate the different embodiments or examples described in this specification.

[0075] Obviously, those skilled in the art can make various modifications and variations to this application without departing from the spirit and scope of this application. Since these modifications and variations fall within the scope of the claims and their equivalents, this application also intends to include these modifications and variations.

[0076] The above description describes specific embodiments of this application, but the scope of protection of this application is not limited thereto. Any person skilled in the art can easily conceive of various equivalent modifications or substitutions within the technical scope disclosed in this application, and these modifications or substitutions should all be covered within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.

Claims

1. A combined blood routine and immunoassay kit, characterized in that, include: Glass slide (202); An immunoassay test strip (3) is placed on the glass slide (202); A glass slide cover plate (2) is provided with a blood routine test structure and is disposed on the glass slide (202) at an interval relative to the immunoassay test strip (3); Double-sided adhesive tape (201) is provided with partition windows for partitioning the glass slide cover plate (2) and is used to attach the glass slide cover plate (2) to the glass slide (202) so that a detection cavity (5) is formed between the glass slide cover plate (2) and the glass slide (202) with the partition windows as the boundary. A reactive material layer (4) is formed inside the detection cavity (5); The reagent kit cover (1) is placed on the glass slide (202).

2. The blood routine and immunoassay combined detection kit according to claim 1, characterized in that, The bottom of the immunoassay test strip (3) is provided with a fixing bracket (301), which is attached to the glass slide (202) by the double-sided adhesive (201).

3. The blood routine and immunoassay combined detection kit according to claim 1, characterized in that, The reagent kit cover (1) is provided with a slide cover clearance groove (11) corresponding to the position of the slide cover (2).

4. The blood routine and immunoassay combined detection kit according to claim 3, characterized in that, The blood routine detection structure of the slide cover plate (2) includes: a first functional area (21) set in one end area of ​​the slide cover plate (2); the partition window on the double-sided adhesive (201) includes a first window (2011) set corresponding to the first functional area (21); the first functional area (21) includes: a first drop hole (203), a first detection area (204) and a first venting groove (205) arranged sequentially from the first end of the slide cover plate (2).

5. The blood routine and immunoassay combined detection kit according to claim 4, characterized in that, The blood routine detection structure of the slide cover plate (2) also includes a second functional area (22), the first functional area (21) and the second functional area (22) are arranged alternately, and the partition window on the double-sided tape (201) includes a second window (2012) corresponding to the second functional area (22); the second functional area (22) includes a second drop hole (208), a second detection area (207) and a second venting groove (206) arranged sequentially from the second end of the slide cover plate (2).

6. The combined blood routine and immunoassay kit according to claim 5, characterized in that, The first drip hole (203) and / or the second drip hole (208) are provided with a boss (209) arranged around the opening.

7. The combined blood routine and immunoassay kit according to claim 1, characterized in that, The glass slide cover plate (2) is also provided with a scale (27).

8. The combined blood routine and immunoassay kit according to claim 1, characterized in that, The immunoassay test strip (3) is an immunoassay gold test strip or an immunofluorescence test strip.

9. The combined blood routine and immunoassay kit according to claim 2, characterized in that, The immunoassay test strip (3) has a sample application area (302), a detection area (303) and an absorbent paper area (304) arranged sequentially along its length; the reagent kit cover plate (1) has a sample application hole (12) corresponding to the sample application area (302) and a viewing window (13) corresponding to the detection area (303).

10. The combined blood routine and immunoassay kit according to claim 1, characterized in that, The reagent kit cover (1) has a recessed groove (14) at one end, and an anti-slip protrusion (15) is provided in the recessed groove (14).

Images