CN210136234U - Immunochromatographic detection device - Google Patents

Abstract

The utility model relates to an immunochromatography detection device, it includes apron, immunochromatography detection piece and the bottom plate that takes a sample. The sample loading part of the sample loading bottom plate is at least matched with the cover plate at the part close to the installation position of the immunochromatography detection piece to form a wetting area, and the height of the wetting area satisfies the following conditions: when the sample solution flows to the wetting area, the sample solution flows along the surface of the sample loading part to the immunochromatographic detection piece under the pushing of capillary action. The wetting area with a certain length is arranged in front of the sample loading area of the immunochromatography detection piece, and when a sample solution flows to the wetting area, a capillary effect is formed to push the sample solution to flow in the wetting area, so that the flow speed of the sample solution in the area can be improved, the basically simultaneous sample loading of the detection piece on different mounting positions can be realized, and the sample loading consistency and uniformity can be improved.

Description

Immunochromatographic detection device

Technical Field

The utility model belongs to the technical field of the external diagnosis technique and specifically relates to an immunochromatography detection device.

Background

In the field of In Vitro Diagnostics (IVD), chromatographic techniques are commonly used to diagnose and detect diseases and other items, for example, an immune colloidal gold test strip, a dry chemical test strip, an immunofluorescence test strip, etc. all use the principle of chromatography to pretreat a sample, then react with a reagent, and finally obtain a Diagnosis result reflecting whether a disease is suffered or not. The fluorescence immunochromatographic test paper has the following action process: after a sample (whole blood, plasma and the like) is dripped into the sample pad, liquid flows to the end of the water absorption filter paper; processing the sample in a sample pad, filtering red blood cells, removing interferents and the like; the sample flows through the combination pad, the antigen-antibody is combined in an immunological way and is provided with fluorescent groups, when the sample flows through the nitrocellulose membrane, the sample is combined with the antigen-antibody specificity which is bound on the nitrocellulose membrane in advance, the fluorescent groups gathered on the test line and the control line can reflect the test result, and other unbound interference substances are absorbed by the absorbent filter paper. The fluorescence immunochromatography has the characteristics of simple and convenient operation, strong specificity, high sensitivity, quantifiability and the like, and is widely applied to the field of POCT detection in recent years. However, in recent decades, most immunochromatographic test cards can only be single cards and single test strips for single item detection. However, with the development of medical technology, the diagnosis of diseases requires the simultaneous detection of multiple targets for more accurate determination, such as the myocardial 3 joint examination and the myocardial 5 joint examination. In some cases, it is necessary to detect the status of multiple organs simultaneously to determine disease, such as a combined heart and lung 5 test.

At present, a plurality of companies are engaged in the research of carrying out a plurality of detections on single sample loading of a single card at home and abroad. For example, Alere company utilizes a microfluidic chip to perform serial myocardial 5-linked detection on the chip, and the technology has the advantages but has obvious disadvantages, mainly the microfluidic chip has high cost and large processing difficulty, the serial detection is easy to interfere with each other, and the technology is a microfluidic technology and does not belong to the field of immunochromatography; the domestic Hayd biological company researches that 3 items are detected in series on a fluorescence immunochromatographic test paper, but the method causes the defects of antibody fixation and avoidance of mutual interference among the items; baiaosen company uses capillary to shunt in the multi-link card, and guides the sample to the test paper, but the processing difficulty of the capillary is high, the impurities in the sample easily affect the function of the capillary, and the card also needs to be drawn away from the separation test paper after sample addition during operation, so the operation is not convenient. Due to the reasons, the multi-link detection card product in the market cannot be widely popularized.

SUMMERY OF THE UTILITY MODEL

In view of the above, it is desirable to provide an immunochromatography detection apparatus having a simple structure and small interference between detection members.

An immunochromatography detection device comprises a cover plate, an immunochromatography detection piece and a sample loading bottom plate; the cover plate and the sample loading bottom plate are matched to enclose a detection cavity, the sample loading bottom plate is provided with a sample loading part, the sample loading part is positioned in the detection cavity, the cover plate is provided with a sample loading hole corresponding to the sample loading part, the sample loading part is used for bearing a sample solution, the sample loading part is provided with a plurality of installation positions, and adjacent installation positions are arranged at intervals; the immunochromatography detection piece is provided with a plurality of immunochromatography detection pieces, and the plurality of immunochromatography detection pieces are respectively arranged on the plurality of installation positions; the sample loading part and the cover plate are matched at least at the part close to the mounting position to form a wetting area, and the height of the wetting area satisfies the following conditions: when the sample solution flows to the wetting area, the sample solution can flow along the surface of the sample loading part to the plurality of immunochromatographic detection pieces under the pushing of capillary action.

In one embodiment, the height of the wetting zone is no greater than 2 mm.

In one embodiment, the height of the wetting zone is 0.1mm to 1 mm.

In one embodiment, the height of the wetting zone is 0.25mm to 0.7 mm.

In one embodiment, the number of the installation positions is not less than four, and a plurality of the installation positions are arranged in parallel.

In one embodiment, each of the mounting positions is an elongated groove-shaped structure extending along the top surface of the highest step, so that an elongated immunochromatographic test strip can be embedded and mounted.

In one embodiment, each of the mounting positions is a cylindrical hole structure which is axially perpendicular to the top surface of the highest step and has openings at two ends, so that the immunochromatographic dry chemical test paper with a laminated structure is embedded and mounted, wherein the opening at the upper end is used for allowing a sample solution to flow into the sample loading area, and the opening at the lower end forms a detection window.

In one embodiment, the sample loading part is of a flat plate-shaped structure, and the wetting area is formed between the planar surface of the sample loading part and the cover plate.

In one embodiment, the sample loading part is of a multi-step structure, wherein a reference surface is used for receiving a sample solution, and the wetting area is formed between the top surface of the highest step and the cover plate.

In one embodiment, the reference surface is an isosceles triangle, and the bottom edge of the reference surface is connected with the side surface of the lowest step;

the length of the top surface of the lowest step is gradually increased along with the approach of a higher step connected with the lowest step; the side surface of the highest step is in a symmetrical arc surface shape, and the side surface of the arc surface shape gradually protrudes from the two ends to the middle to the end where the reference surface is located.

When multiple items are detected or the same item is detected in parallel, the effect of sample adding detection by using different or same single immunochromatographic detection test paper and other immunochromatographic detection pieces is better, because the existing single immunochromatographic detection test paper and other detection technologies are more mature, the technology and the process are also perfect. Therefore, the utility model discloses an immunochromatography detection device designs on the basis of a plurality of present widely used individual item immunochromatography detection pieces. However, research shows that the main influencing factor of the plurality of immunochromatography detection pieces during detection is that multiple times of sample addition easily cause difficulty in unifying time and sample parallel lines, so that the accuracy of a test result is influenced, the detection efficiency is reduced due to multiple times of sample addition, and the risk of error occurrence is increased.

Therefore, the utility model discloses an immunochromatography detection device sets up the wetting zone that has certain length before the district that takes a sample of immunochromatography detection piece, when sample solution flows to the wetting zone time, can form capillary action, promotes sample solution and flows in the wetting zone, so not only can improve the flow velocity of sample solution in this region, can also realize the basic while that detects the piece on the different installation position and take a sample, is favorable to improving the uniformity and the homogeneity that take a sample.

Moreover, the bottom plate of getting on the throne and contain this immunochromatography detection device who gets on the throne of getting on the throne when the design, the portion of getting on the throne of area add a multistage stair structure, this portion of getting on the throne of sample has the multistage stair step of difference, its reference surface is used for accepting sample solution, sample solution back on the reference surface, can flow upwards, through the damming and buffering effect of multistage stair step structure, the last sample solution that finally flows to on the top surface of highest level step can flow to the portion of getting on each immunochromatography detection piece basically simultaneously, a plurality of immunochromatography detection pieces just so can accept sample solution basically simultaneously, do not have the unified problem on time and the sample parallel line, the test accuracy is high, and. When the immunochromatography detection device is used for detection, each immunochromatography detection piece is independently detected, and simultaneously, the immunochromatography detection piece is loaded, so that mutual interference does not exist, and the accuracy of a detection result is further improved.

Traditional many blocks of card immunochromatography detection device that ally oneself with is poor because of the inconsistency of appearance of loading, and the immunochromatography detection piece of different installation positions is difficult to realize the appearance of loading simultaneously to the appearance volume of loading is also inhomogeneous, leads to generally can only realize trigeminy or quadruple and detects, can't carry out the detection of quintuplet or more than quintuplet. And use the sample loading bottom plate that has above-mentioned structure and/or control sample loading bottom plate and apron between the distance in order to form capillary action in moist district, the utility model discloses an immunochromatography detection device can realize that the sample loading that allies oneself with of quintuplet, six ally oneself with even more immunochromatography detection pieces is measured to sample loading uniformity is good, and testing result accuracy and reliability effectively improve.

Drawings

FIG. 1 is a partially exploded view of an immunochromatographic assay device according to an embodiment of the present invention;

FIG. 2 is a cross-sectional view of the immunochromatographic test device of FIG. 1 after assembly;

FIG. 3 is a schematic view showing the construction of an immunochromatographic detection member in the immunochromatographic detection device shown in FIG. 1;

FIG. 4 is a partially exploded view of an immunochromatographic assay device according to another embodiment of the present invention;

FIG. 5 is a cross-sectional view of the immunochromatographic test device of FIG. 4 after assembly;

FIG. 6 is a schematic view showing the construction of an immunochromatographic detection member in the immunochromatographic detection device shown in FIG. 5;

fig. 7a and 7b, 8a and 8b, and 9a and 9b are a top view and a corresponding cross-sectional view, respectively, of a cushioning structure having other step structures.

Description of reference numerals:

10: an immunochromatographic detection device; 20: a sample adding pipe; 100. 500, 834: a cover plate; 102. 502: a detection chamber; 110: a sample application hole; 120: detecting a window; 200. 700, 832: an immunochromatographic detection member; 210: a substrate; 220: a sample pad; 230: a bonding pad; 240: a detection membrane; 242: detecting lines; 250: an absorbent pad; 300. 600, 810, 820, 831: a sample loading bottom plate; 310. 833: a sample loading part; 311: a reference plane; 320: a lowest step; 321: the side of the lowest step; 322: a top surface of a lowest step; 330: a second step; 340. 640: a highest step; 341: the side of the highest step; 342. 642: the top surface of the highest step; 510: air holes are formed; 710: a support layer; 720: a reaction layer; 721: a reagent layer; 722: a display layer; 730: a diffusion layer.

Detailed Description

In order to facilitate understanding of the present invention, the present invention will be described more fully hereinafter with reference to the accompanying drawings. The preferred embodiments of the present invention are shown in the drawings. The invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

It will be understood that when an element is referred to as being "secured to" or "disposed" on another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

Referring to fig. 1, 2 and 3, an embodiment of the present invention provides an immunochromatography detection device 10, which includes a cover plate 100, an immunochromatography detection member 200 and a sample loading base plate 300. The cover plate 100 and the loading base plate 300 cooperate to define a detection chamber 102. The loading base 300 has a loading portion 310. The loading portion 310 is located within the detection chamber 102. The cover plate 100 is provided with a loading hole 110 corresponding to the loading part 310. The immunochromatographic detection device 200 has a plurality of immunochromatographic detection devices 200, and the plurality of immunochromatographic detection devices 200 are mounted on the sample loading plate 300.

Preferably, the loading hole 110 corresponds to an end of the loading portion 310 away from the immunochromatography detection member 200, so that the sample solutions (such as blood, serum, saliva, and the like) can be transferred in a flowing manner from substantially the same starting point, and the loading distance of the sample solution can be extended to some extent, which facilitates the slow buffering of the flowing of the sample solution for a relatively long distance, so as to ensure the consistency of the loading.

Further preferably, the axial direction of the sample adding hole 110 is inclined relative to the cover plate 100, and the sample adding hole is inclined a little according to the force applied to the sample solution flowing out of the sample adding tube 20 and the direction of the liquid to be guided, so that when the sample adding tube 20 is inserted into the sample adding hole 110 to extrude the sample solution, the sample adding effect is better than that in the direction perpendicular to the cover plate 100, and the sample solution is more favorably and uniformly and rapidly distributed. More preferably, the well 110 is inclined from the inlet end to the outlet end toward the portion where the immunochromatographic detection member 200 is located. The axial direction of the sample hole 110 may form an angle with the cover plate 100 of, but not limited to, 40 ° to 70 °, such as 40 °, 45 °, 50 °, 55 °, 60 °, 65 °, or 70 °. It is understood that in other specific examples, the axial direction of the loading hole 110 may be perpendicular to the cover plate 100.

More preferably, the inner diameter of the sample application hole 110 gradually decreases from the inlet end to the outlet end, that is, the whole sample application hole 110 is in an inverted truncated cone shape (the bottom has a small size), so that the sample application hole is matched with the shape of the sample application tube 20, the sample application tube 20 can be fixed more stably, the sample application tube 20 is prevented from swinging forward, backward, leftward and rightward in the sample application process, the consistency of the sample application position is ensured, and the consistency of the subsequent flow of the sample solution to the sample application region of each immunochromatography detection piece 200 is favorably ensured.

In the specific example shown in fig. 1, the cover plate 100 is provided with a detection window 120 corresponding to a detection region of the immunochromatographic detection member 200. The detection window 120 may be used not only for observing the detection result, but also for ventilation so as to facilitate the flow of the sample solution in the detection chamber 102.

In the specific example shown in fig. 1 to 3, the immunochromatographic test strip 200 is a general-purpose strip-shaped immunochromatographic test strip, and includes a substrate 210, and a sample pad 220, a binding pad 230, a detection membrane 240, and an absorption pad 250, which are provided on the substrate 210 and connected in sequence from one end of the substrate 210 to the other end. Substrate 210 may be a PVC substrate. The sample pad 220 has a loading area. The conjugate pad 230 contains a fluorescent group or a color reagent-labeled antibody or the like. Detection membrane 240 may be a nitrocellulose membrane having detection lines 242 thereon. A control line (not shown) may be disposed on the detection membrane 240. The detection window 120 covers at least the detection line 242.

In the present embodiment, the loading part 310 of the loading base plate 300 has a multi-step structure with gradually increasing height. Wherein the reference surface 311 located at the bottommost portion of the multi-step structure is used for receiving a sample solution. The uppermost step 340 has a plurality of mounting positions (labeled in the figure) for mounting a detector such as the immunochromatographic detector 200. The adjacent mounting positions are spaced apart, for example, but not limited to, 1mm to 4 mm. After the cover plate 100 is covered, the sample solution can flow upward from the reference surface 311 and flow to each installation site at substantially the same time after being stopped and buffered by the multistage step structure.

The substantially same time may be, for example, the time difference between the first arrival and the last arrival at the corresponding mounting location is not more than 1.0s, 0.6s, 0.5s, 0.4s, 0.3s, 0.2s, or the like; preferably, the time difference between the first arrival and the last arrival at the corresponding mounting location does not exceed 0.3 s.

In the illustrated specific example, the reference surface 311 and the top surface of each step of the multi-step structure are both planar structures, and the reference surface 311 is disposed parallel to the top surface of each step. During detection, the reference surface 311 and the top surfaces of the steps are horizontally arranged, so that the sample loading stability can be ensured.

Preferably, the reference surface 311 is an isosceles triangle, and the bottom side is connected to the side 321 of the lowest step 320. The isosceles triangle base surface 311 is beneficial to the liquid to uniformly diffuse and flow to the bottom side of the triangle. When the sample solution flows on the reference surface 311, the sample solution forms an arc shape, the middle liquid contacts the bottom side of the triangle first, that is, the middle area of the bottom side of the isosceles triangle contacts the liquid first, and the two ends are later; when the middle flowing sample solution first contacts the side 321 of the lowest step 320, because the side 321 has a certain height, the speed of the middle flowing sample solution is reduced after contacting the side 321, and the middle flowing sample solution flows to both ends, while the liquid on both sides of the reference plane 311 does not contact both ends of the side 321, and the original relatively fast flow rate is maintained, so when the sample solution flowing to both sides along the side 321 and the sample solution on both sides of the reference plane 311 converge, the flow rates of the sample solutions on both sides of the reference plane 311 are neutralized and balanced, that is, the flow rates of the middle flowing sample solution and the sample solutions on both sides are balanced, and the difference is reduced.

The loading hole 110 corresponds to an end of the reference surface 311 far from the lowest step 320. For the reference surface 311 of the isosceles triangle, the sampling hole 110 corresponds to a position between the center of gravity of the isosceles triangle and the vertex angle thereof.

In the illustrated embodiment, the length of the top surface 322 of the lowest step 320 gradually increases as it approaches the second step 330 connected thereto, so that the flow rate of the sample solution flowing along the top surface 322 is further decreased due to the gradually increasing width, and thus the difference in the flow rate at each position is further decreased.

Preferably, both ends of the top surface 322 of the lowest step 320 are arc-shaped, and the arc-shaped ends are symmetrically arranged, so that a smooth transition buffer is formed, and the influence on the overall flow rate control balance due to partial position asymmetry is avoided.

The lengths of the intermediate steps may be uniform throughout the top surface 342 of the uppermost step 340. Because the flow rate of the sample solution is under the buffering deceleration and balance action of the reference surface 311 and the lowest step 320 of the first stage, the flow rate ratio of the sample solution reaching the top surfaces 342 of the middle steps and the highest step 340 is lower, and in order to ensure the sample loading speed, the lengths of the middle steps and the top surfaces 342 of the highest steps 340 are kept consistent, so that the sample solution can stably flow upwards.

Further, the side 341 of the highest step 340 is in a symmetrical arc shape, and the side 341 of the arc shape gradually protrudes from the two ends to the middle to the end where the reference surface 311 is located, that is, the width of the top of the next highest step gradually increases from the middle to the two ends. After the intercepting and buffering action of the previous step structures, the sample solution reaching the top surface of the next higher step can flow forwards at a certain constant speed basically, when the sample solution meets the arc-shaped side surface 341, the sample solution can flow towards the two ends rapidly under the guidance of the arc surface, the arc-shaped side surface 341 can play a role in guiding, and the sample solution flowing towards the two ends can continue to converge with the sample solution flowing towards the two ends, so that the flow speed and the flow of the sample solution flowing in the middle and the two ends are further balanced.

Preferably, for example, in the example shown in fig. 1 to 3, the sample loading part 310 is a three-step structure, wherein an initial buffer area is formed between the reference surface 311 and the cover plate 100, a two-step transition buffer area is formed between the lowest first step 320 and the middle second step 330 and the cover plate 100, and a wetting area is formed between the highest third step 340 and the cover plate 100 for loading the sample loading area of the mounted detection sensor.

In the particular example shown in fig. 1-3, each mounting location is an elongated, trough-like structure extending along the top surface 342 of the highest step 340. The immunochromatographic detection piece 200 is an immunochromatographic detection test strip, and is embedded and mounted in the groove-shaped structure. The ends of the plurality of mounting sites are positioned flush so that the sample solution is controlled to reach each sample application zone substantially simultaneously on the top surface 342 of the uppermost step 340. Preferably, the plurality of mounting positions are arranged in parallel, and when the immunochromatographic test strip is mounted, the sample loading end of the test strip protrudes from the top surface 342 of the highest step 340.

The cover plate 100 and the loading base plate 300 can be fixed together by, but not limited to, a fixing means such as a double-sided tape or a snap structure.

In a specific example, the spacing between the cover plate 100 and the loading part 310 satisfies: when the sample solution flows to the wetting zone (corresponding to fig. 1 to 3, i.e., the space between the top surface 342 of the highest step 340 and the cover plate 100), the sample solution flows along the surface of the loading portion 310 to the position of the loading zone of the immunochromatographic detection member 200 under the capillary action.

Preferably, the height of the wetting zone (i.e., the distance between the cover plate 100 and the top surface 342 of the highest step 340) is no greater than 2 mm. Experimental research shows that when the height of the wetting area is larger than 2mm, the wetting area is not easy to form laminar flow, bubbles are easy to generate, and the capillary action is not easy to form. Further preferably, the height of the wetting zone is 0.1mm to 1 mm. When the height of the wetting area is less than 0.1mm, the height is not easy to control, the processing difficulty and the process difficulty are high, and the sample loading speed is influenced. More preferably, the height of the wetting zone is 0.25mm to 0.7mm, and within this range, the laminar flow of the liquid is more effective and bubbles are less likely to be generated.

Through structural design, make sample solution can flow through capillary action in corresponding region, especially sample solution can cover this top surface 342 rapidly between top surface 342 and apron 100 of highest level step 340, not only can rely on capillary action to the whole appearance of going up of sample solution to the detection piece like this, can also show and improve the speed of going up the appearance, reduce the problem that influences the efficiency of going up the appearance because of the sample solution velocity of flow that dams and the cushioning effect of multistage step structure lead to reduces, improve the efficiency of going up the appearance, and then improve detection efficiency.

In the specific example shown in fig. 1 to 3, when the sample solution can substantially reach each strip-shaped immunochromatography test strip at the same time through the interception and buffering action of the multi-step structure, the sample pad 220 can rapidly absorb the sample solution after contacting the sample solution, the absorbed liquid completes the sample processing process in the region, the antigen-antibody is immunologically combined through the combination pad 230 and carries the fluorescent group, and when flowing through the detection membrane 240, the antigen-antibody is specifically combined with the antigen-antibody bound thereon in advance, the excessive unreacted substance is absorbed by the absorption pad 250, and the fluorescent group gathered at the detection line 242 on the detection membrane 240 can reflect the test result. Because the basic structure of each immunochromatography detection piece 200 is the same in multiple detections, only the above antigen-antibody are different, and the antigen-antibody does not affect the water absorption effect, when each immunochromatography detection piece 200 simultaneously contacts with a sample to generate adsorption, the method can be equivalent to evenly distributing the sample to each immunochromatography detection piece 200. The experimental test result shows that the error of the parallelism of the immunochromatography detection device 10 is less than 5 percent, so that the requirements of immunochromatography in-vitro diagnosis and detection can be met.

This immunochromatography detection device can directly use original immunochromatography detection piece 200 under the condition that does not change original single immunochromatography detection piece 200, directly carry out single application of sample, carry out a plurality of project detection simultaneously. The immunochromatography detection device is simple in structure, easy to process and manufacture, low in cost, convenient to sample, short in time consumption, strong in stability and high in accuracy of average distribution sample amount.

In other embodiments, as shown in fig. 4 to 6, each mounting position may also be a cylindrical hole structure with two open ends, which is axially perpendicular to the top surface 642 of the highest step 640, so as to allow the immunochromatographic detection piece 700, such as a dry chemical detection test strip, with a laminated structure to be mounted in an embedded manner, wherein the open end is used for forming an upper sample region for a sample solution to flow in, and the open end forms a detection window.

The immunochromatographic detection device 700 having a laminated structure comprises a support layer 710, a reaction layer 720 and a diffusion layer 730 laminated in this order. The diffusion layer 730 has a sample application region, and the reaction layer 720 contains a reaction reagent capable of reacting with a target substance and a color-developing agent.

Specifically, the reaction layer 720 includes a reagent layer 721 and a color-developing layer 722 that are disposed in a stacked manner, and the color-developing layer 722 is closer to the support layer 710. The reagent layer 721 contains a reaction reagent capable of reacting with a target substance, and the color developing layer 722 contains a developer; alternatively, the reagent layer 721 contains a developer, and the color developing layer 722 contains a reactive agent capable of reacting with the target substance.

Preferably, the cover plate 500 is provided with a vent 510 communicating with the detection chamber 502 at a region corresponding to the immunochromatographic detection member 700, so as to allow venting, and to ensure a balance in air pressure in the detection chamber 502, so that the sample solution smoothly flows.

The utility model discloses a go up appearance bottom plate is not limited to and is used for going up appearance to immunochromatography detection piece, like being not limited to the immunochromatography detection test paper strip of above-mentioned rectangular shape or the dry chemical detection test paper of immunochromatography of stromatolite structure, still can be other detection pieces, like electrochemistry detection piece etc. Through using apron and the cooperation of the bottom plate that samples loading, can realize homogeneity and the uniformity to the sample loading of different detection pieces.

Above-mentioned immunochromatography detection device is when the design, add a multistage stair structure's last appearance portion in last appearance region, this last appearance portion has the multistage stair structure of high difference, its reference surface is used for accepting sample solution, cover the apron back, sample solution falls on the reference surface after, can upwards flow, through multistage stair structure's damming and cushioning effect, the last sample region that sample solution that finally flows to on the top surface of highest level step can flow to each immunochromatography detection piece simultaneously basically, a plurality of immunochromatography detection pieces just can accept sample solution basically simultaneously like this, there is not the unified problem on time and the sample parallel line, the test accuracy is high, and only need the application of sample once, detection efficiency is high, the risk of appearing the error is also smaller. When the immunochromatography detection device is used for detection, each immunochromatography detection piece is independently detected, and simultaneously, the immunochromatography detection piece is loaded, so that mutual interference does not exist, and the accuracy of a detection result is further improved.

Moreover, above-mentioned immunochromatography detection device sets up the wetting zone that has certain length at the upstream of immunochromatography detection spare upper run district, when the sample solution flows to the wetting zone, can form capillary action, promotes sample solution and flows at the wetting zone, so not only can improve the flow velocity of sample solution in this region, can also realize the basic simultaneous upper run of detection spare on different installation positions, be favorable to improving the uniformity and the homogeneity of upper run.

Traditional many blocks of card immunochromatography detection device that ally oneself with is poor because of the inconsistency of appearance of loading, and the immunochromatography detection piece of different installation positions is difficult to realize the appearance of loading simultaneously to the appearance volume of loading is also inhomogeneous, leads to generally can only realize trigeminy or quadruple and detects, can't carry out the detection of quintuplet or more than quintuplet. And use the sample loading bottom plate that has above-mentioned structure and/or control the distance between sample loading bottom plate and the apron in order to form capillary action in moist district, the utility model discloses an immunochromatography detection device can realize the sample loading of quintuplet, six antithetical couplets and detect to the sample loading uniformity is good, and testing result accuracy and reliability effectively improve.

Please refer to fig. 7a, fig. 7b, fig. 8a, fig. 8b, fig. 9a and fig. 9b, the present invention compares and analyzes the sample loading effect of the sample loading base plates with different structures.

Comparison and analysis of the height of the wetting zone in contact with the sample application zone of the test element

Taking the loading plate 831 shown in fig. 9a and 9b as an example, the loading plate 831 does not have a step structure, and the loading portion 833 located between the loading region of the immunochromatographic detection element 832 and the loading hole has a flat plate-like structure. A wetting zone is formed between the loading portion 833 and the cover plate 834.

And controlling the heights of the wetting areas to be 0.1mm, 0.25mm, 0.5mm, 0.7mm, 1mm, 1.5mm, 3mm, 3.5mm, 4mm and 4.5mm respectively, and observing the sample loading condition of the quintuplet immunochromatography detection test strip.

The results show that the sample loading consistency is obviously improved relative to the heights of 3mm, 3.5mm, 4mm and 4.5mm when the heights of the wetting areas are several heights of 0.1mm, 0.25mm, 0.5mm, 0.7mm, 1mm and 1.5mm, and the sample loading consistency is better when the heights are 0.25mm, 0.5mm or 0.7 mm.

Shoot video slow-speed lens and show, when highly being 0.1mm, 0.25mm, 0.5mm, 0.7mm, 1mm, 1.5mm, sample solution can flow at moist district fast, can confirm through the analysis that capillary action has been formed in this region, is favorable to sample solution to flow fast, therefore is favorable to quick appearance, reduces the appearance time difference of going up of the detection piece that different installation positions go out to a certain extent. Whereas at a wetted zone height of 3mm, 3.5mm, 4mm or 4.5mm, the wetted zone has bubble formation, capillary action is affected and thus sample loading consistency is affected.

Similarly, the wetting zones of different heights were also tested on the loading plate shown in fig. 1 or fig. 4, fig. 7a and 7b, and fig. 8a and 8b, and the results were substantially the same as those of the structure shown in fig. 9a and 9 b.

Therefore, the wetting zone is formed before the sample loading zone of the detection part, and the height of the wetting zone is controlled, so that the sample solution can form capillary action when entering the wetting zone to improve the flow speed of the sample solution, thereby reducing the sample loading time difference at different positions to a certain extent and improving the sample loading consistency.

Second, experiment and analysis of influence of sample loading parts with different structures on sample loading consistency

The radian of the buffer area, the wetting area and the buffer area with different structures and the number of the buffer steps have influence on the effect of the average distribution of the liquid. The sample loading base plates 300 and 600 shown in fig. 1 and 4 are a preferred embodiment of the present invention, and the design has the minimum deviation CV value on the liquid average distribution, which is less than 3%, and the stability is good, and the test shows that the probability of 1 or 2 non-sample loading in 5 immunochromatography detection pieces is less than 1%.

In the other loading bottom plate 831 shown in fig. 9a and 9b, since there is no buffer, the immunochromatographic detection member among 5 immunochromatographic detection members comes into contact with the liquid first, and thus the CV deviation of the average distribution of the liquid is relatively large. In the sample loading base plate 810 shown in fig. 7a and 7b, the reference plane is arc-shaped, and compared with the isosceles triangle shown in fig. 1, 4 and 9a, experimental results of this scheme indicate that two immunochromatographic detection members located at the outermost side may be relatively prone to sample unloading, and the triangle is beneficial to guiding liquid to flow to both ends to avoid the phenomenon that liquid at both ends is not loaded. Thus, the loading plate 810 shown in fig. 7a and 7b is possible, but the loading effect is slightly inferior to that of the loading plates 300 and 600 shown in fig. 1 and 4, but is significantly superior to that of the loading plate 831 shown in fig. 9a and 9 b.

However, as the sample loading bottom plate 820 shown in fig. 8a and 8b has 5 buffer areas, since the buffer areas are dense and the assisting force for the liquid to flow upward and uphill is large, the liquid may not enter the wetting area (i.e. the top surface of the highest step), and the probability of sample loading failure is relatively increased; moreover, since the depth of the buffer region is large, the immunochromatographic detection member may cut off the flow of the liquid when absorbing the liquid, and the liquid of the reference surface and the first-stage buffer region of the lowest-stage step may not be completely absorbed, and the accuracy of the sample application may be directly affected by the partial residue. Thus, the loading plate 820 shown in fig. 8a and 8b is feasible, but the loading effect is slightly inferior to that of the loading plates 300 and 600 shown in fig. 1 and 4, but is significantly better than that of the loading plate 831 shown in fig. 9a and 9 b.

Thus, overall, for the structural design of the sample application part, a suitable buffer zone has a direct influence on the average distribution of the liquid. Multiple simulations and experiments show that the schemes shown in fig. 1 and fig. 4 are preferable, the average distribution error is small, the probability of no sample is extremely low, and the schemes shown in fig. 7a and fig. 8a are feasible in some cases.

In summary, the uniformity of the loading of the detecting structure on different mounting positions can be improved by controlling the height of the wetting zone to form capillary action in the wetting zone, or by improving the average distribution of liquid through the structural design of the proper buffer zone. Preferably, capillary action is used in combination with the structural design of the appropriate buffer zone, which further enhances loading.

It can be understood that, for the detecting device capable of forming capillary action in the wetting area, the sample loading part of the sample loading base plate can be not limited to the step-like structure shown in fig. 1, fig. 4, fig. 7a or fig. 8a, but also can be a flat structure shown in fig. 9a and fig. 9b, thus compared with the traditional detecting device, the sample loading consistency of different detecting members can be improved to a certain extent, the structure is simple, the interference among different detecting members is also reduced, and the accuracy of the detecting result is improved. For a test device using capillary action to improve the uniformity of loading, the height of the wetting zone is preferably no more than 2mm, such as between 0.1mm and 1mm, and more preferably between 0.25mm and 0.7 mm.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only represent some embodiments of the present invention, and the description thereof is specific and detailed, but not to be construed as limiting the scope of the present invention. It should be noted that, for those skilled in the art, without departing from the spirit of the present invention, several variations and modifications can be made, which are within the scope of the present invention. Therefore, the protection scope of the present invention should be subject to the appended claims.

Claims (10)

1. An immunochromatography detection device is characterized by comprising a cover plate, an immunochromatography detection piece and a sample loading bottom plate; the cover plate and the sample loading bottom plate are matched to enclose a detection cavity, the sample loading bottom plate is provided with a sample loading part, the sample loading part is positioned in the detection cavity, the cover plate is provided with a sample loading hole corresponding to the sample loading part, the sample loading part is used for bearing a sample solution, the sample loading part is provided with a plurality of installation positions, and adjacent installation positions are arranged at intervals; the immunochromatography detection piece is provided with a plurality of immunochromatography detection pieces, and the plurality of immunochromatography detection pieces are respectively arranged on the plurality of installation positions; the sample loading part and the cover plate are matched at least at the part close to the mounting position to form a wetting area, and the height of the wetting area satisfies the following conditions: when the sample solution flows to the wetting zone, the sample solution can flow along the surface of the sample loading part to the plurality of immunochromatographic detection members under the pushing of capillary action.

2. The immunochromatographic test device of claim 1, wherein the height of the wetting zone is not more than 2 mm.

3. The immunochromatographic test device of claim 2, wherein the wetting zone has a height of 0.1mm to 1 mm.

4. The immunochromatographic test device of claim 3, wherein the wetting zone has a height of 0.25mm to 0.7 mm.

5. The immunochromatographic detection device according to any one of claims 1 to 4, wherein the number of the mounting positions is not less than four, and a plurality of the mounting positions are arranged in parallel.

6. The immunochromatographic test device of claim 5, wherein each mounting site is an elongated slot-like structure extending along the top surface of the highest step, so that an elongated immunochromatographic test strip can be embedded and mounted.

7. The immunochromatographic detection device of claim 5, wherein each mounting position is a cylindrical hole structure which is axially perpendicular to the top surface of the highest step and has openings at two ends, so that immunochromatographic dry chemical test paper of a laminated structure can be embedded and mounted, wherein the opening at the upper end is used for allowing a sample solution to flow into the sample loading area, and the opening at the lower end forms a detection window.

8. The immunochromatographic detection device according to any one of claims 1 to 4 and 6 to 7, wherein the sample application part has a flat plate-like structure, and the wetting zone is formed between the flat surface and the cover plate.

9. The immunochromatographic detection device according to any one of claims 1 to 4 and 6 to 7, wherein the sample loading part is a multi-step structure, wherein a reference surface located at the bottommost part of the multi-step structure is used for receiving a sample solution, and the wetting zone is formed between the top surface of the highest step and the cover plate.

10. The immunochromatographic detection device of claim 9, wherein the reference surface is in the shape of an isosceles triangle, and the bottom side is connected to the side surface of the lowest step;

the length of the top surface of the lowest step is gradually increased along with the approach of a higher step connected with the lowest step; the side surface of the highest step is in a symmetrical arc surface shape, and the side surface of the arc surface shape gradually protrudes from the two ends to the middle to the end where the reference surface is located.

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