WO2020143219A1 - 上样底板及含有该上样底板的免疫层析检测装置 - Google Patents

上样底板及含有该上样底板的免疫层析检测装置 Download PDF

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Publication number
WO2020143219A1
WO2020143219A1 PCT/CN2019/098729 CN2019098729W WO2020143219A1 WO 2020143219 A1 WO2020143219 A1 WO 2020143219A1 CN 2019098729 W CN2019098729 W CN 2019098729W WO 2020143219 A1 WO2020143219 A1 WO 2020143219A1
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Prior art keywords
sample
sample loading
detection
immunochromatography
bottom plate
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PCT/CN2019/098729
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English (en)
French (fr)
Inventor
蒙玄
杜嘉铭
黄锡荣
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广州万孚生物技术股份有限公司
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Priority to US17/421,854 priority Critical patent/US20220105508A1/en
Priority to KR1020217025450A priority patent/KR102616679B1/ko
Priority to JP2021540187A priority patent/JP7186302B2/ja
Priority to EP19908785.9A priority patent/EP3910333A4/en
Publication of WO2020143219A1 publication Critical patent/WO2020143219A1/zh

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5027—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
    • B01L3/50273—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip characterised by the means or forces applied to move the fluids
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5023—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures with a sample being transported to, and subsequently stored in an absorbent for analysis
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L9/00—Supporting devices; Holding devices
    • B01L9/52—Supports specially adapted for flat sample carriers, e.g. for plates, slides, chips
    • B01L9/527—Supports specially adapted for flat sample carriers, e.g. for plates, slides, chips for microfluidic devices, e.g. used for lab-on-a-chip
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G01N33/54386—Analytical elements
    • G01N33/54387—Immunochromatographic test strips
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G01N33/54386—Analytical elements
    • G01N33/54387—Immunochromatographic test strips
    • G01N33/54388—Immunochromatographic test strips based on lateral flow
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G01N33/54386—Analytical elements
    • G01N33/54387—Immunochromatographic test strips
    • G01N33/54391—Immunochromatographic test strips based on vertical flow
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/02—Adapting objects or devices to another
    • B01L2200/021—Adjust spacings in an array of wells, pipettes or holders, format transfer between arrays of different size or geometry
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/02—Adapting objects or devices to another
    • B01L2200/028—Modular arrangements
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/16—Reagents, handling or storing thereof
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/04—Closures and closing means
    • B01L2300/041—Connecting closures to device or container
    • B01L2300/042—Caps; Plugs
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B01L2300/0825—Test strips
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0887—Laminated structure
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
    • B01L2400/0406—Moving fluids with specific forces or mechanical means specific forces capillary forces

Definitions

  • the invention relates to the technical field of in vitro diagnosis, in particular to a loading base plate and an immunochromatographic detection device containing the loading base plate.
  • chromatography techniques are often used to diagnose and test diseases, such as immunocolloid gold test strips, dry chemical test strips, and immunofluorescence test strips. After processing, reacting with reagents, and finally get a diagnosis result reflecting whether there is a disease.
  • the role of fluorescent immunochromatographic test paper is as follows: after the sample (whole blood, plasma, etc.) is dropped into the sample pad, the liquid flows to the end of the absorbent filter paper; the sample is processed in the sample pad to filter red blood cells, remove interferences, etc.; the sample flow Through the binding pad, the antigen and antibody are immunologically bound and brought with a fluorescent group. When flowing through the nitrocellulose membrane, they specifically bind to the antigen and antibody bound in advance.
  • the fluorescent groups accumulated on the test line and control line can reflect According to the test results, unbound other interfering substances are absorbed by the absorbent filter paper. Because of its easy operation, strong specificity, high sensitivity, and quantifiable characteristics, fluorescent immunochromatography technology has been widely used in the field of POCT detection in recent years. However, in recent decades, the vast majority of immunochromatographic test cards can only be a single card with a single test strip for single item detection. However, with the development of medical technology, the diagnosis of diseases requires the simultaneous detection of multiple targets to make more accurate judgments, such as the joint examination of myocardium 3 and the joint examination of myocardium 5. In some cases, it is necessary to detect the status of multiple organs at the same time to determine the disease, such as cardiopulmonary 5 joint examination.
  • Bioson uses capillary shunt in the multi-card to drain the sample to the test paper, but the processing of the capillary is difficult, and impurities in the sample easily affect the function of the capillary.
  • the card When the card is in operation, it also needs to be removed from the barrier test paper after sample addition, and the operation is not convenient. Due to the above reasons, the multi-detection card products on the market cannot be widely promoted.
  • a sample loading base plate which has a sample loading part; the sample loading part is a multi-step structure with increasing height, wherein the reference plane at the bottom of the multi-step structure is used to receive a sample solution.
  • the highest step of the stepped structure has a plurality of mounting positions for mounting the detection element, and the adjacent mounting positions are spaced apart.
  • the position of the reference surface near the front end is sampled, and the sample solution can pass through the multi-stage
  • the flow interception buffer of the step structure flows to each of the installation positions at substantially the same time.
  • the detection element is an immunochromatographic test paper
  • the sample loading area is located on the installation position.
  • the multiple installation positions satisfy at least one of the following conditions:
  • the distance between adjacent installation positions is 1 mm to 4 mm.
  • the reference surface and the top surface of each step of the multi-step structure are both planar structures, and the reference surface is disposed parallel to the top surface of each step.
  • the reference plane is an isosceles triangle, and the bottom edge is connected to the side of the lowest step.
  • the length of the top surface of the lowest step gradually increases as it approaches the higher step connected to it.
  • both ends of the top surface of the lowest step are arc-shaped, and the arc shapes of the two ends are symmetrically arranged.
  • the length of the top surface of the middle step and the top level of the step are kept the same.
  • the side surface of the highest step has a symmetrical arc shape, and the arc-shaped side surface gradually protrudes from both ends to the middle toward the end where the reference plane is located.
  • the loading part is a three-step structure.
  • An immunochromatography detection device includes a cover plate, an immunochromatography detection element, and a sample loading bottom plate according to any one of the foregoing embodiments; the cover plate cooperates with the sample loading bottom plate to form a detection cavity, and the sample loading The part is located in the detection cavity; the cover plate is provided with a sample addition hole corresponding to the reference surface of the sample loading part; there are a plurality of immunochromatography detection parts, and a plurality of the immunochromatography detection parts The sample areas are respectively installed on the plurality of installation positions.
  • the sampling hole is close to an end of the reference plane away from the lowest step.
  • the axial direction of the sampling hole is inclined relative to the cover plate.
  • the inner diameter of the sampling hole gradually decreases from the inlet end to the outlet end.
  • the distance between the cover plate and the sample loading section satisfies: when the sample solution flows to the space between the top surface of the highest level step of the sample section and the cover plate
  • the sample solution can flow along the surface of the sample loading portion to the position of the sample loading area of the immunochromatographic detection member under the capillary action.
  • the distance between the top surface of the highest level step of the sample loading portion and the cover plate is not greater than 2 mm.
  • each of the installation positions is an elongated groove-like structure extending along the top surface of the highest-level step, so that the elongated immunochromatographic detection component is embedded and installed.
  • the immunochromatographic detection component includes a substrate and a sample pad, a binding pad, a detection membrane, and an absorption pad provided on the substrate and connected in sequence from one end to the other end of the substrate.
  • the sample pad has the loading area
  • the detection membrane has a detection line.
  • the cover plate is provided with a detection window for observing the detection line of each immunochromatographic detection element.
  • each of the installation positions is a columnar hole structure having an axial direction perpendicular to the top surface of the highest level step and open at both ends, so as to embed and install the immunochromatographic detection component of the stacked structure,
  • the opening at the upper end is used for the sample solution to flow into the sample loading area, and the opening at the lower end constitutes a detection window.
  • the immunochromatographic detection component includes a support layer, a reaction layer, and a diffusion layer stacked in this order, the diffusion layer having the loading area, and the reaction layer containing a reaction capable of reacting with a target substance Reagents and developer.
  • the reaction layer includes a stacked reagent layer and a color development layer, and the color development layer is closer to the support layer;
  • the reagent layer contains a reaction reagent capable of reacting with a target substance, and the color developing layer contains a color developing agent; or the reagent layer contains a color developing agent, and the color developing layer contains a reaction capable of reacting with a target substance Reagents.
  • the cover plate is provided with a vent hole communicating with the detection chamber in an area corresponding to the immunochromatographic detection member.
  • the immunochromatography detection device of the present invention is designed based on a plurality of single-item immunochromatography detection pieces that are currently widely used.
  • the main influencing factor of multiple immunochromatographic test pieces during detection is that multiple sample additions are prone to time and the sample parallel lines are difficult to unify, which will affect the accuracy of the test results, and many times Adding samples will reduce the detection efficiency and increase the risk of errors.
  • a sample loading part with a multi-step structure is added to the sample loading area, and the sample loading part has multi-steps with different heights
  • the reference surface is used to receive the sample solution. After the sample solution falls on the reference surface, it will flow upward.
  • the sample solution that finally flows to the top surface of the highest level step can be substantially simultaneously Flow to the loading area of each immunochromatographic test piece, so that multiple immunochromatographic test pieces can receive the sample solution at the same time, there is no uniform problem of time and sample parallel lines, the test accuracy is high, and only one time is required
  • the sample is added, the detection efficiency is high, and the risk of errors is relatively small.
  • each immunochromatography detection piece is independently detected, and the samples are loaded at the same time, there is no mutual interference with each other, which is further conducive to improving the accuracy of the detection result.
  • the above-mentioned immunochromatography detection device is provided with a wetting zone with a certain length upstream of the sample zone on the immunochromatography detection part.
  • a capillary action is formed, which promotes the wetting of the sample solution Zone flow, which not only can increase the flow rate of the sample solution in this area, but also can achieve the sample at the same time at different installation positions of the sample at the same time, which is conducive to improving the consistency and uniformity of the sample.
  • the immunochromatographic detection device of the present invention can realize five-segment and six-segment sample loading Detection, and the consistency of sample loading is good, and the accuracy and reliability of the test results are effectively improved.
  • FIG. 1 is a partially exploded schematic view of an immunochromatography detection device according to an embodiment of the invention
  • FIG. 2 is a cross-sectional view of the immunochromatography detection device shown in FIG. 1 after assembly;
  • FIG. 3 is a schematic structural diagram of an immunochromatographic detection element in the immunochromatography detection device shown in FIG. 1;
  • FIG. 4 is a partially exploded schematic diagram of an immunochromatography detection device according to another embodiment of the invention.
  • FIG. 5 is a cross-sectional view of the immunochromatography detection device shown in FIG. 4 after assembly;
  • FIG. 6 is a schematic structural diagram of an immunochromatography detection component in the immunochromatography detection device shown in FIG. 5;
  • 7a and 7b, 8a and 8b, and 9a and 9b are a top view and a corresponding cross-sectional view of a buffer structure having other stepped structures, respectively.
  • 10 Immunochromatography detection device; 20: sample tube; 100, 500, 834: cover plate; 102, 502: detection chamber; 110: sample hole; 120: detection window; 200, 700, 832: immunochromatography Test piece; 210: substrate; 220: sample pad; 230: bonding pad; 240: detection film; 242: detection line; 250: absorption pad; 300, 600, 810, 820, 831: loading base plate; 310, 833: Sample loading part; 311: reference surface; 320: lowest step; 321: side of lowest step; 322: top surface of lowest step; 330: second step; 340, 640: highest step; 341: most The side surface of the high-level step; 342, 642: the top surface of the highest level step; 510: vent hole; 710: support layer; 720: reaction layer; 721: reagent layer; 722: display layer; 730: diffusion layer.
  • an embodiment of the present invention provides an immunochromatography detection device 10, which includes a cover plate 100, an immunochromatography detection element 200 and a sample loading base 300.
  • the cover plate 100 cooperates with the loading bottom plate 300 to form a detection cavity 102.
  • the sample loading base 300 has a sample loading part 310.
  • the sample loading part 310 is located in the detection cavity 102.
  • the cover plate 100 is provided with a sample adding hole 110 corresponding to the sample loading part 310.
  • There are a plurality of immunochromatographic detection components 200, and a plurality of immunochromatographic detection components 200 are installed on the sample loading base 300.
  • the sample loading hole 110 corresponds to the end of the sample loading part 310 away from the immunochromatographic detection member 200, so that the sample solution (such as blood, serum, saliva, etc.) can be flow-transferred at substantially the same starting point, or To a certain extent, the sampling distance of the sample solution is extended, which is conducive to a relatively long-distance deceleration buffer for the flow of the sample solution to ensure the consistency of the sample.
  • the sample solution such as blood, serum, saliva, etc.
  • the axial direction of the sample loading hole 110 is inclined relative to the cover plate 100, and is set a little bit inclined according to the force of the sample solution flowing out of the sample loading tube 20 and the direction in which the liquid needs to be guided, so that when the sample loading tube 20 is inserted into the sample loading When the sample solution is extruded from the hole 110, the sample addition effect is better than the direction perpendicular to the cover plate 100, and it is more conducive to the uniform and rapid distribution of the sample solution. More preferably, the loading hole 110 is inclined and approached from the entrance end to the exit end toward the location where the immunochromatographic detection member 200 is located.
  • the angle between the axial direction of the loading hole 110 and the cover plate 100 may be, but not limited to, 40°-70°, such as 40°, 45°, 50°, 55°, 60°, 65°, or 70°. It can be understood that, in other specific examples, the axial direction of the sample loading hole 110 may also be perpendicular to the cover plate 100.
  • the inner diameter of the sample hole 110 gradually decreases from the inlet end to the outlet end, that is, the entire sample hole 110 has a rounded truncated cone shape (the size of the bottom is small), so that it can be adapted to the shape of the sample tube 20.
  • the sample tube 20 prevent the sample tube 20 from swinging in the front, back, left and right during the sample loading process, ensure the consistency of the sample loading position, and help ensure the subsequent flow of the sample solution to each immunochromatographic detection The consistency of the sample area of the piece 200.
  • the cover plate 100 is provided with a detection window 120 corresponding to the detection area of the immunochromatographic detection member 200.
  • the detection window 120 can be used not only for observing the detection result, but also for ventilation, so that the sample solution flows smoothly in the detection chamber 102.
  • the immunochromatographic detection element 200 is a general elongated immunochromatographic detection test strip, which includes a base 210 and a base 210 provided on and from the base 210 A sample pad 220, a bonding pad 230, a detection film 240, and an absorption pad 250 connected in sequence from one end to the other end.
  • the substrate 210 may be a PVC substrate.
  • the sample pad 220 has a loading area.
  • the binding pad 230 contains an antibody labeled with a fluorescent group or a developer.
  • the detection film 240 may be a nitrocellulose film having a detection line 242 thereon.
  • a quality control line (not shown) can also be provided on the detection membrane 240.
  • the detection window 120 should at least cover the detection line 242.
  • the sample loading part 310 of the sample loading base 300 is a multi-stage stepped structure whose height increases step by step.
  • the reference surface 311 at the bottom of the multi-step structure is used to receive the sample solution.
  • the highest level step 340 has a plurality of mounting positions (marked in the figure) for mounting detection components such as the immunochromatography detection component 200.
  • the spacing between adjacent installation positions can be set, for example, at intervals but not limited to 1 mm to 4 mm.
  • the substantially same time may be, for example, the difference between the time of the first arrival and the last arrival of the corresponding installation position does not exceed 1.0s, 0.6s, 0.5s, 0.4s, 0.3s or 0.2s, etc.; preferably, the first arrival and the last The time to reach the corresponding installation position should not exceed 0.3s.
  • 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.
  • the reference surface 311 and the top surface of the steps at each level are set horizontally, which can ensure the stability of the loading.
  • the reference plane 311 is an isosceles triangle, and the bottom edge is connected to the side surface 321 of the lowest step 320.
  • the reference surface 311 of the isosceles triangle is conducive to the uniform diffusion of liquid to the bottom of the triangle. When the sample solution flows on the reference surface 311, it will form an arc shape.
  • the liquid in the middle will first contact the bottom of the triangle, that is, the middle area of the bottom of the isosceles triangle will first contact the liquid, and the two ends will be later; when the sample solution flowing in the middle When first touching the side 321 of the lowest step 320, since the side 321 has a certain height, the speed of the sample solution in the middle is reduced after touching the side 321, and flows to both ends, while the liquid on both sides of the reference plane 311 The two ends of the side surface 321 have not yet been touched, and the original relatively fast flow rate is maintained.
  • the reference surface 311 The flow rate of the sample solution on the side is neutralized and balanced, that is, the flow rates of the sample solution flowing in the middle and the sample solutions on both sides are balanced, and the difference is reduced.
  • the sampling hole 110 corresponds to the end of the reference surface 311 away from the lowest step 320.
  • the sample hole 110 corresponds to the position between the center of gravity of the isosceles triangle and its apex angle.
  • 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 when the sample solution flows along the top surface 322, the flow rate is gradually increased due to the gradually increasing width It is further reduced, and the difference in flow velocity at each position is further reduced.
  • both ends of the top surface 322 of the lowest step 320 are arc-shaped, and the arcs at both ends are symmetrically arranged, so as to form a smooth transition buffer and avoid affecting the overall flow rate control balance due to asymmetry of partial positions.
  • the lengths of the intermediate steps and the top surface 342 of the highest step 340 can be kept the same. Since the flow rate of the sample solution is under the buffer deceleration and balance of the reference surface 311 and the lowest step 320 of the first stage, the flow rate of the sample solution reaching the top surface 342 of the middle step and the highest step 340 is relatively low. The sample loading speed, the lengths of the middle steps and the top surface 342 of the highest step 340 are kept the same, which can make the sample solution flow smoothly upward.
  • the side surface 341 of the highest level step 340 has a symmetrical arc shape, and the curved side surface 341 gradually protrudes from both ends to the middle toward the end where the reference plane 311 is located, that is, the width of the top surface of the second level step The middle gradually increases towards both ends.
  • the sample solution reaching the top surface of the sub-high level step can basically maintain a constant constant flow forward.
  • the sample solution hits the arc-shaped side surface 341 the Under the guidance of the arc surface, it will quickly flow to the two ends.
  • the arc-shaped side 341 can play a guiding role. The sample solution flowing to the two ends will continue to converge with the sample solution flowing at the two ends, thereby further balancing The flow rate and flow rate of the sample solution flowing in the middle and both ends.
  • the loading part 310 is a three-step structure, in which an initial buffer area is formed between the reference surface 311 and the cover plate 100, the lowest first step 320 and the middle A second-stage transition buffer zone is formed between the second step 330 and the cover plate 100, and the highest third step 340 and the cover plate 100 serve as a wetting area for loading the sample area of the installed detection sensor.
  • each mounting position is a long groove-like structure extending along the top surface 342 of the highest level step 340.
  • the immunochromatography detection component 200 is an immunochromatography detection test strip, embedded and installed in the groove-like structure.
  • the ends of the multiple installation positions are flush with each other, so that on the top surface 342 of the highest level step 340, the sample solution can be controlled to reach each loading area substantially simultaneously.
  • a plurality of installation positions are arranged in parallel, and when the immunochromatographic detection test strip is installed, the loading end of the test strip protrudes from the top surface 342 of the highest level step 340.
  • the cover plate 100 and the sample bottom plate 300 can be fixed together by but not limited to double-sided tape or snap structure.
  • the distance between the cover plate 100 and the loading part 310 satisfies: when the sample solution flows to the wetting area (corresponding to FIGS. 1 to 3, that is, the top surface 342 of the highest level step 340 and the cover plate 100 The space between them), the sample solution will be driven by the capillary action to flow along the surface of the sample loading part 310 to the position of the sample loading area of the immunochromatographic detection member 200.
  • the height of the wetted area (that is, the distance between the cover plate 100 and the top surface 342 of the highest step 340) is not greater than 2 mm.
  • the height of the wetted area is 0.1 mm to 1 mm.
  • the height of the wetted area is 0.25 mm to 0.7 mm, and within this range, the liquid laminar flow effect is better, and bubbles are not easily generated.
  • the sample solution can flow through the capillary action in the corresponding area, especially the sample solution can quickly cover the top surface 342 between the top surface 342 of the highest step 340 and the cover plate 100, so that not only can rely on capillary action All the sample solution is loaded onto the test piece, which can also significantly increase the sample loading speed, reduce the problem of the sample solution flow rate due to the multi-stage stepped flow interception and buffering effect, which affects the sample loading efficiency, and improve the sample loading efficiency. Improve detection efficiency.
  • the sample solution when intercepted and buffered by the multi-step structure, it can reach each strip immunochromatographic test strip at substantially the same time, and the sample pad 220 contacts the sample After the solution can quickly absorb the sample solution, the absorbed liquid completes the sample processing process in this area, and then passes through the binding pad 230, the antigen and antibody are immunologically bound, and carry a fluorescent group, flow through the detection membrane 240, and pre-bound on it
  • the antigen and antibody bind specifically, the excess unreacted substance is absorbed by the absorption pad 250, and the fluorescent group accumulated on the detection line 242 on the detection membrane 240 can reflect the test result.
  • each immunochromatographic detection component 200 Since the basic structure of each immunochromatographic detection component 200 is the same during multiple tests, except that the above antigen and antibody are different, and the antigen antibody does not affect the water absorption effect, it is ensured that each immunochromatographic detection component 200 contacts the sample at the same time. During adsorption, the samples can be equally distributed to each immunochromatographic detection component 200. The result of the experimental test shows that the error of the parallelism of the above immunochromatography detection device 10 is less than 5%, so it can meet the needs of immunochromatography in vitro diagnostic detection.
  • the immunochromatography detection device can directly apply the original immunochromatography detection piece 200 without changing the original single immunochromatography detection piece 200, directly perform a single sample addition, and perform multiple items detection at the same time.
  • the immunochromatographic detection device has a simple structure, is easy to process and manufacture, has low cost, and is convenient for sample loading, short in time consumption, strong in stability, and high in accuracy of average sample distribution.
  • each mounting position may also be a columnar hole structure with the axial direction perpendicular to the top surface 642 of the highest step 640 and open at both ends, for example
  • the immunochromatographic detection element 700 of the chemical detection test paper is embedded and installed, wherein the opening at the upper end is used to form a sample loading area for sample solution to flow in, and the opening at the lower end constitutes a detection window.
  • the immunochromatographic detection element 700 of the stacked structure includes a supporting layer 710, a reaction layer 720 and a diffusion layer 730 stacked in this order.
  • the diffusion layer 730 has a sample loading area, and the reaction layer 720 contains a reaction reagent and a color developer capable of reacting with a target substance.
  • the reaction layer 720 includes a reagent layer 721 and a color developing layer 722 that are stacked, 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 color developing agent; or the reagent layer 721 contains a color developing agent, and the color developing layer 722 contains a reaction reagent capable of reacting with the target substance.
  • the cover plate 500 is provided with a vent hole 510 in communication with the detection chamber 502 in an area corresponding to the immunochromatography detection member 700, so as to facilitate ventilation, and to ensure that the air pressure in the detection chamber 502 is balanced so that the sample solution can flow smoothly.
  • the sample loading bottom plate of the present invention is not limited to use for loading immunochromatographic detection components.
  • it is not limited to the above-mentioned strip-shaped immunochromatographic detection test strips or stacked-layer immunochromatography dry chemical detection test strips.
  • detection parts such as electrochemical detection parts.
  • a sample loading part with a multi-step structure is added to the sample loading area, the sample loading part has a multi-step structure with different heights, and its reference surface is used to receive the sample solution and cover After the plate, after the sample solution falls on the reference surface, it will flow upward. After the interception and buffering of the multi-step structure, the sample solution that finally flows to the top surface of the highest level step can flow to each immunochromatographic test at the same time.
  • the sample loading area of the sample so that multiple immunochromatographic test pieces can basically receive the sample solution at the same time, there is no uniform problem of time and sample parallel lines, the test accuracy is high, and only one sample is needed, and the detection efficiency is high. The risk of errors is also relatively small.
  • each immunochromatography detection piece is independently detected, and the samples are loaded at the same time, there is no mutual interference with each other, which is further conducive to improving the accuracy of the detection result.
  • the above-mentioned immunochromatography detection device is provided with a wetting zone with a certain length upstream of the sample zone on the immunochromatography detection part.
  • a capillary action is formed, which promotes the wetting of the sample solution Zone flow, which not only can increase the flow rate of the sample solution in this area, but also can achieve the sample at the same time at different installation positions of the sample at the same time, which is conducive to improving the consistency and uniformity of the sample.
  • the immunochromatographic detection device of the present invention can realize five-segment and six-segment sample loading Detection, and the consistency of sample loading is good, and the accuracy and reliability of the test results are effectively improved.
  • the present invention compares and analyzes the loading effect of loading base plates with different structures.
  • the sample loading bottom plate 831 does not have a stepped structure, and the sample loading portion 833 between the sample loading hole and the sample loading area of the immunochromatographic detection element 832 is Flat structure. A wetted area is formed between the sample loading part 833 and the cover plate 834.
  • Control the height of the wetted area to be 0.1mm, 0.25mm, 0.5mm, 0.7mm, 1mm, 1.5mm, 3mm, 3.5mm, 4mm, and 4.5mm, and observe the loading of the test strips by the five-layer immunochromatography test.
  • Slow-motion video shooting shows that at a height of 0.1mm, 0.25mm, 0.5mm, 0.7mm, 1mm, 1.5mm, the sample solution can flow quickly in this wetted area, and it can be determined that capillary action has been formed in this area through analysis. It is conducive to the rapid flow of the sample solution, and therefore it is conducive to rapid sample loading, and to a certain extent, reduces the sample loading time difference of the detection parts at different installation positions.
  • the height of the wetted area is 3mm, 3.5mm, 4mm or 4.5mm, bubbles are formed in the wetted area and the capillary effect is affected, so the consistency of the loading is also affected.
  • the flow rate of the sample solution can be increased by forming a wetting zone before the sample loading zone of the test piece, and by controlling the height of the wetting zone so that the sample solution can form a capillary effect when entering the wetting zone. To a certain extent, it reduces the time difference of loading at different positions and improves the consistency of loading.
  • the buffer zone, the wetting zone and the buffer zone of different structures and the buffer steps have an effect on the average distribution of liquid.
  • the loading base plates 300 and 600 shown in FIGS. 1 and 4 are a preferred solution of the present invention.
  • the CV value of the deviation in the average liquid distribution of this design is the smallest, less than 3%, and has good stability. After testing, 5 immunizations The probability that there is one or two samples that are not loaded in the chromatography detection part is less than 1%.
  • the immunochromatographic detection piece among the five immunochromatographic detection pieces will first contact the liquid, so the CV deviation of the average distribution of the liquid Relatively large.
  • the reference plane is curved.
  • the experimental results of this scheme show that it is located at the outermost side.
  • the two immunochromatographic detection components may be relatively prone to sample failure, and the triangle is helpful to guide the flow of liquid to both ends and avoid the phenomenon that the liquid at both ends does not load. Therefore, the loading base 810 shown in FIGS. 7a and 7b is feasible, but the loading effect is slightly worse than the loading bases 300 and 600 shown in FIGS. 1 and 4, but is significantly better than that shown in FIGS. 9a and 9b.
  • the loading effect of the loading base 831 is slightly worse than the loading bases 300 and 600 shown in FIGS. 1 and 4, but is significantly better than that shown in FIGS. 9a and 9b.
  • the loading base 820 shown in FIGS. 8a and 8b is feasible, but the loading effect is slightly worse than the loading bases 300 and 600 shown in FIGS. 1 and 4, but is significantly better than that shown in FIGS. 9a and 9b.
  • the loading effect of the loading base 831 is slightly worse than the loading bases 300 and 600 shown in FIGS. 1 and 4, but is significantly better than that shown in FIGS. 9a and 9b.
  • a suitable buffer zone has a direct influence on the average distribution of the liquid.
  • the height of the wetted area can be controlled to form a capillary effect in the wetted area, or the structural design of the appropriate buffer zone can be used to improve the average distribution of liquid to improve the sampling of the detection structure at different installation positions. consistency.
  • the capillary action can be used in combination with a suitable buffer structure design, which can further improve the loading effect.
  • the sample loading portion of the sample loading base plate may not be limited to the stepped structure shown in FIG. 1, FIG. 4, FIG. 7a, or FIG. 8a, or may be as shown in FIG.
  • the flat structure shown in 9a and 9b compared with the traditional detection device, can also improve the consistency of the loading of different detection parts to a certain extent, and the structure is simple, and the interference between different detection parts is also reduced. Help to improve the accuracy of the test results.
  • the height of the wetted area is preferably not more than 2 mm, such as may be between 0.1 mm and 1 mm, and further preferably between 0.25 mm and 0.7 mm.

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Abstract

一种上样底板（300、600、810、820、831）及含有该上样底板（300、600、810、820、831）的免疫层析检测装置（10）。该上样底板（300、600、810、820、831）在设计时，在上样区域增设一多级台阶结构的上样部（310、833），其具有高度不同的多级台阶，其中基准面（311）用于承接样本溶液。盖上盖板（100、500、834）后，样本溶液落在基准面（311）上后，会向上流动，经过多级台阶结构的截流和缓冲作用，最终流至最高级台阶（340、640）的顶面（342、642）上的样本溶液能够基本同时流至各免疫层析检测件的上样区，这样多个免疫层析检测件就可以基本同时接受样本溶液，不存在时间和样本平行线上的统一问题，测试准确性高，并且只需要一次加样，检测效率高，出现误差的风险也比较小。检测时，各免疫层析检测件独立检测，同时上样，相互之间不存在相互干扰，检测结果准确性高。

Description

上样底板及含有该上样底板的免疫层析检测装置 技术领域
本发明涉及体外诊断技术领域，尤其是涉及一种上样底板及含有该上样底板的免疫层析检测装置。
背景技术
体外诊断(In vitro Diagnosis，IVD)领域中经常用到层析技术对疾病等项目进行诊断检测，例如免疫胶体金试纸、干化学试纸、免疫荧光试纸等都是运用层析的原理对样本进行前处理、再和试剂反应，最后得到反映出是否患有疾病的诊断结果。其中荧光免疫层析试纸的作用过程为：样本(全血、血浆等)滴加入样本垫后，液体向吸水滤纸端流动；在样本垫中进行样本处理，过滤红细胞、去除干扰物等；样本流过结合垫，抗原抗体免疫结合，并带上荧光基团，流过硝酸纤维素膜时，和预先绑定在上面的抗原抗体特异性结合，测试线和控制线上聚集的荧光基团可反映出测试结果，未结合的其他干扰物质则被吸水滤纸吸收。由于荧光免疫层析技术具有操作简便、特异性强、灵敏度高、可定量等特点，近些年在POCT检测领域中得到广泛应用。然而，近几十年来，绝大多数免疫层析测试卡只能是单张卡配单张试纸进行单个项目检测。但是随着医学技术的发展，疾病的诊断需要同时检测多个靶标来进行更加准确的判定，例如心肌3联检、心肌5联检等。在某些情况下，需要同时检测多个器官的状态来判定疾病，如心肺5联检等。
目前，国内外有多家公司从事单张卡单次加样进行多项检测的研究。例如Alere公司利用微流控芯片，在芯片上进行串联的心肌5联检测，该技术存在优点，但是也有明显的不足，主要是微流控芯片成本高，加工难度大，而且是串联检测相互间容易干扰，并且该技术为微流控技术也不属于免疫层析的范畴；国内的海格德生物公司研究在荧光免疫层析试纸上串联进行3个项目检测，但是这种方式使得在抗体固定、避免项目间相互干扰上存在不足；百奥森公司则在多联卡中运用毛细管分流，把样本引流到试纸上，但是运用毛细管的加工难度大，样本中的杂质容易影响毛细管的作用，该卡在操作时还需要在加样后抽离隔挡试纸，操作也不便捷。由于以上多种原因，所以市面上多联检测卡产品还不能广泛推广。
发明内容
基于此，有必要提供一种结构简单、且检测件间干扰小的上样底板及含有该上样底板的 免疫层析检测装置。
一种上样底板，具有上样部；所述上样部为高度逐级递增的多级台阶结构，其中位于所述多级台阶结构的最底部的基准面用于承接样本溶液，所述多级台阶结构的最高级台阶具有多个用于安装检测件的安装位，相邻的所述安装位之间间隔设置。
在其中一个实施例中，当在所述上样部上设置能够将其覆盖的平面状盖板时，对所述基准面的靠近其前端的位置进行加样，样品溶液能够经所述多级台阶结构的截流缓冲后以基本相同的时间流至各所述安装位。
在其中一个实施例中，所述检测件为免疫层析试纸，且其上样区位于所述安装位上。
在其中一个实施例中，多个所述安装位满足如下条件中的至少一个：
多个所述安装位的端部齐平设置；
多个所述安装位平行设置；和
相邻的所述安装位之间间距1mm～4mm。
在其中一个实施例中，所述基准面以及所述多级台阶结构的各级台阶的顶面均为平面结构，且所述基准面与各级台阶的顶面平行设置。
在其中一个实施例中，所述基准面呈等腰三角形，且底边与最低级台阶的侧面连接。
在其中一个实施例中，所述最低级台阶的顶面的长度随靠近与其连接的更高一级台阶逐渐增大。
在其中一个实施例中，所述最低级台阶的顶面的两端呈弧形，且两端的弧形对称设置。
在其中一个实施例中，中间各级台阶与最高级台阶的顶面的各处长度保持一致。
在其中一个实施例中，最高级台阶的侧面呈对称的弧面状，且该弧面状的侧面从两端至中间向基准面所在端逐渐凸出。
在其中一个实施例中，所述上样部为三级台阶结构。
一种免疫层析检测装置，包括盖板、免疫层析检测件以及上述任一实施例所述的上样底板；所述盖板与所述上样底板配合围成检测腔，所述上样部位于所述检测腔内；所述盖板对应于所述上样部的基准面设有加样孔；所述免疫层析检测件有多个，多个所述免疫层析检测件的上样区分别对应安装在多个所述安装位上。
在其中一个实施例中，所述加样孔靠近于所述基准面的远离最低级台阶的一端。
在其中一个实施例中，所述加样孔的轴向相对于所述盖板倾斜设置。
在其中一个实施例中，所述加样孔从入口端至出口端内径逐渐减小。
在其中一个实施例中，所述盖板与所述上样部之间的间距满足：当样本溶液流至所述上 样部的最高级台阶的顶面与所述盖板之间的空间时，样本溶液能够在毛细作用的推动下沿所述上样部的表面向所述免疫层析检测件的上样区所在位置流动。
在其中一个实施例中，所述上样部的最高级台阶的顶面与所述盖板之间的距离不大于2mm。
在其中一个实施例中，各所述安装位为沿所述最高级台阶的顶面延伸的长条形的槽状结构，以供长条形的免疫层析检测件嵌设安装。
在其中一个实施例中，所述免疫层析检测件包括基底和设在所述基底上且从所述基底的一端至另一端顺次连接的样品垫、结合垫、检测膜及吸收垫，所述样品垫具有所述上样区，所述检测膜具有检测线。
在其中一个实施例中，所述盖板上设有用于观察各所述免疫层析检测件的检测线的检测窗口。
在其中一个实施例中，各所述安装位为轴向垂直于所述最高级台阶的顶面的、两端开口的柱状孔结构，以供叠层结构的免疫层析检测件嵌设安装，其中，上端的开口用于供样本溶液流入至所述上样区，下端的开口构成检测窗口。
在其中一个实施例中，所述免疫层析检测件包括依次层叠设置支持层、反应层和扩散层，所述扩散层具有所述上样区，所述反应层含有能够与目标物质反应的反应试剂和显色剂。
在其中一个实施例中，所述反应层包括层叠设置的试剂层和显色层，所述显色层更靠近于所述支持层；
所述试剂层中含有能够与目标物质反应的反应试剂，所述显色层含有显色剂；或者所述试剂层中含有显色剂，所述显色层中含有能够与目标物质反应的反应试剂。
在其中一个实施例中，所述盖板在对应于所述免疫层析检测件的区域设有与所述检测腔连通的透气孔。
在多项目检测或同一项目平行检测时，使用不同或相同的单项免疫层析检测试纸等免疫层析检测件进行加样检测是效果比较好的，因为目前单项免疫层析检测试纸等检测技术发展比较成熟，其技术和工艺也很完善。因此，本发明的免疫层析检测装置以多个目前广泛使用的单项免疫层析检测件为基础进行设计。但经过研究发现，多个免疫层析检测件在检测时的主要影响因素是多次加样易造成时间上、样本平行线上难以统一，这样对测试结果的准确性会产生影响，并且多次加样会降低检测效率，还加大了出现误差的风险。
因此，本发明的上样底板及含有该上样底板的免疫层析检测装置在设计时，在上样区域增设一多级台阶结构的上样部，该上样部具有高度不同的多级台阶，其基准面用于承接样本 溶液，样本溶液落在基准面上后，会向上流动，经过多级台阶结构的截流和缓冲作用，最终流至最高级台阶的顶面上的样本溶液能够基本同时流至各免疫层析检测件的上样区，这样多个免疫层析检测件就可以基本同时接受样本溶液，不存在时间和样本平行线上的统一问题，测试准确性高，并且只需要一次加样，检测效率高，出现误差的风险也比较小。该免疫层析检测装置在检测时，各免疫层析检测件独立检测，同时上样，相互之间不存在相互干扰，进一步有利于提高检测结果的准确性。
不仅如此，上述免疫层析检测装置在免疫层析检测件上样区的上游设置具有一定长度的润湿区，当样本溶液流至润湿区时，会形成毛细作用，推动样本溶液在润湿区流动，这样不仅可以提高样本溶液在此区域的流动速度，还可以实现不同安装位上检测件的基本同时上样，有利于提高上样的一致性和均匀性。
传统的多联卡免疫层析检测装置，因上样的不一致性差，不同安装位的免疫层析检测件难以实现同时上样，并且上样量也不均匀，导致一般只能实现三联或四联检测，无法进行五联或五联以上的检测。而使用具有上述结构的上样底板和/或控制上样底板与盖板之间的距离以在润湿区形成毛细作用，本发明的免疫层析检测装置可以实现五联、六联的上样检测，并且上样一致性好，检测结果准确性和可靠性有效提高。
附图说明
图1为本发明一实施例的免疫层析检测装置的部分分解示意图；
图2为图1所示免疫层析检测装置装配后的剖视图；
图3为图1所示免疫层析检测装置中的免疫层析检测件的结构示意图；
图4为本发明另一实施例的免疫层析检测装置的部分分解示意图；
图5为图4所示免疫层析检测装置装配后的剖视图；
图6为图5所示免疫层析检测装置中的免疫层析检测件的结构示意图；
图7a和7b、8a和8b、图9a和图9b分别为具有其他台阶结构的缓冲结构的俯视图和对应的剖视图。
附图标记说明：
10：免疫层析检测装置；20：加样管；100、500、834：盖板；102、502：检测腔；110：加样孔；120：检测窗口；200、700、832：免疫层析检测件；210：基底；220：样品垫；230：结合垫；240：检测膜；242：检测线；250：吸收垫；300、600、810、820、831：上样底板；310、833：上样部；311：基准面；320：最低级台阶；321：最低级台阶的侧面；322：最低 级台阶的顶面；330：第二级台阶；340、640：最高级台阶；341：最高级台阶的侧面；342、642：最高级台阶的顶面；510：透气孔；710：支持层；720：反应层；721：试剂层；722：显示层；730：扩散层。
具体实施方式
为了便于理解本发明，下面将参照相关附图对本发明进行更全面的描述。附图中给出了本发明的较佳实施例。但是，本发明可以以许多不同的形式来实现，并不限于本文所描述的实施例。相反地，提供这些实施例的目的是使对本发明的公开内容的理解更加透彻全面。
需要说明的是，当元件被称为“固定于”、“设于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本发明。本文所使用的术语“和/或”包括一个或多个相关的所列项目的任意的和所有的组合。
请结合图1、图2和图3，本发明一实施例提供了一种免疫层析检测装置10，其包括盖板100、免疫层析检测件200以及上样底板300。盖板100与上样底板300配合围成检测腔102。上样底板300具有上样部310。该上样部310位于检测腔102内。盖板100对应于上样部310设有加样孔110。免疫层析检测件200有多个，多个免疫层析检测件200安装在上样底板300上。
优选地，加样孔110对应于上样部310的远离免疫层析检测件200的一端，这样可以使样本溶液(如血液、血清、唾液等)都以基本相同的起点进行流动转移，还可以在一定程度上延长样本溶液的上样距离，有利于对样本溶液的流动进行相对长距离减速缓冲，以保证上样的一致性。
进一步优选地，加样孔110的轴向相对于盖板100倾斜设置，根据样本溶液流出加样管20的受力及需要引导液体的方向，倾斜一点设置，这样当加样管20插入加样孔110挤出样本溶液时，较之垂直于盖板100的方向加样效果更佳，更有利于样本溶液均匀快速分布。更优选的，加样孔110从入口端至出口端向免疫层析检测件200所在的部位倾斜靠近。加样孔110的轴向与盖板100的夹角可以是但不限于40°～70°，如可以是40°、45°、50°、55°、60°、65°或70°。可理解，在其他具体示例中，加样孔110的轴向也可以垂直于盖板100 设置。
更优选地，加样孔110从入口端至出口端内径逐渐减小，也即整个加样孔110呈倒圆台形(底部尺寸小)，这样与加样管20的形状相适配，可以更为稳定的固定加样管20，防止在加样过程中，加样管20前、后、左、右摆动，保证加样位置的一致性，有利于保证样本溶液后续流动至各免疫层析检测件200的上样区的一致性。
在图1所示的具体示例中，盖板100对应于免疫层析检测件200的检测区设有检测窗口120。检测窗口120不仅可以用于观察检测结果，还可以用于透气，以使样本溶液在检测腔102内顺利流动。
在图1～图3所示的具体示例中，所述免疫层析检测件200为通用的长条形的免疫层析检测试纸条，包括基底210和设在基底210上且从基底210的一端至另一端顺次连接的样品垫220、结合垫230、检测膜240及吸收垫250。基底210可以是PVC基底。样品垫220具有上样区。结合垫230上含有荧光基团或显色剂标记的抗体等。检测膜240可以是硝酸纤维素膜，其上具有检测线242。检测膜240上还可以设置质控线(图未示)。检测窗口120至少要覆盖检测线242。
在本实施例中，上样底板300的上样部310为高度逐级递增的多级台阶结构。其中位于该多级台阶结构的最底部的基准面311用于承接样本溶液。最高级台阶340具有多个用于安装免疫层析检测件200等检测件的安装位(图中为标示)。相邻的安装位之间间隔设置，例如可以间隔但不限于1mm～4mm设置。盖上盖板100后，样本溶液能够自基准面311向上流动，并经多级台阶结构截流缓冲后以基本相同的时间流至各安装位。
所述基本相同的时间例如可以是最先到达与最后到达相应安装位的时间相差不超过1.0s、0.6s、0.5s、0.4s、0.3s或0.2s等；优选地，最先到达与最后到达相应安装位的时间相差不超过0.3s。
在图示的具体示例中，基准面311以及多级台阶结构的各级台阶的顶面均为平面结构，且基准面311与各级台阶的顶面平行设置。在检测时，基准面311与各级台阶的顶面均水平设置，可以保证上样的平稳性。
优选地，基准面311呈等腰三角形，且底边与最低级台阶320的侧面321连接。等腰三角形的基准面311，有利于液体均匀扩散流向三角形的底边。样本溶液在基准面311上流动时，会形成弧形状，中间的液体会先接触三角形的底边，即等腰三角形底边的中间区域先接触液体，两端稍后；当中间流动的样本溶液先碰到最低级台阶320的侧面321时，由于侧面321具有一定的高度，因而中间的样本溶液在触碰到侧面321后速度被降低，同时向两端流 动，而基准面311两侧的液体还未触碰到侧面321的两端，保持原来的相对较快的流速流动，因而当沿侧面321流向两侧的样本溶液与基准面311原两侧的样本溶液汇聚时，基准面311原两侧的样本溶液的流速被中和平衡，也即中间流动的样本溶液和两侧的样本溶液的流速被平衡，差异减小。
加样孔110对应于基准面311的远离最低级台阶320的一端。对于等腰三角形的基准面311，加样孔110对应于等腰三角形重心与其顶角之间的位置。
在图示的具体示例中，最低级台阶320的顶面322的长度随靠近与其连接的第二级台阶330逐渐增大，这样样本溶液沿着顶面322流动时，由于宽度逐渐增加，流速被进一步降低，进而各位置的流速差异进一步减小。
优选地，该最低级台阶320的顶面322的两端呈弧形，且两端的弧形对称设置，这样形成平稳的过渡缓冲，避免因部分位置不对称影响整体的流速控制平衡。
中间各级台阶与最高级台阶340的顶面342的各处长度可以保持一致。由于样本溶液的流速在基准面311和第一级的最低级台阶320的缓冲减速和平衡作用下，到达中间各级台阶与最高级台阶340的顶面342的样本溶液的流速比较低，为保证上样速度，中间各级台阶与最高级台阶340的顶面342的各处长度保持一致，可以使样本溶液平稳向上流动。
进一步，最高级台阶340的侧面341呈对称的弧面状，且该弧面状的侧面341从两端至中间向基准面311所在端逐渐凸出，也即次高级台阶的顶面的宽度从中部向两端逐渐增大。经前面几级台阶结构的截流和缓冲作用后，到达次高级台阶的顶面的样本溶液基本能保持一定的恒速向前流动，当样本溶液在碰到该弧面状的侧面341后，在弧面的引导下，会迅速向两端流动，该弧面状的侧面341可以起到一个导流的作用，流向两端的样本溶液会继续与原两端流动的样本溶液汇聚，从而进一步平衡了中间和两端流动的样本溶液的流速和流量。
优选地，例如在图1～3所示的示例中，该上样部310为三级台阶结构，其中基准面311与盖板100之间形成初始缓冲区，最低的第一级台阶320和中间的第二级台阶330与盖板100之间形成二级过渡缓冲区，最高的第三级台阶340与盖板100之间作为润湿区用于对安装的检测传感器的上样区上样。
在图1～3所示的具体示例中，各安装位为沿最高级台阶340的顶面342延伸的长条形的槽状结构。免疫层析检测件200为免疫层析检测试纸条，嵌设安装在该槽状结构中。多个安装位的端部齐平设置，这样在最高级台阶340的顶面342，可以控制样本溶液基本同时到达各上样区。优选地，多个安装位平行设置，且当免疫层析检测试纸条安装后，试纸条的上样端凸出于最高级台阶340的顶面342。
盖板100与上样底板300之间可以通过但不限于双面胶或卡扣结构件等固定方式固定在一起。
在一个具体示例中，盖板100与上样部310之间的间距满足：当样本溶液流至润湿区(对应于图1～图3，即最高级台阶340的顶面342与盖板100之间的空间)时，样本溶液会在毛细作用的推动下沿上样部310的表面向免疫层析检测件200的上样区所在位置流动。
优选地，润湿区的高度(也即盖板100与最高阶台阶340的顶面342之间的距离)不大于2mm。通过实验研究发现，当大于润湿区的高度大于2mm时，润湿区不易形成层流，容易产生气泡，不易形成毛细作用。进一步优选地，润湿区的高度为0.1mm～1mm。当润湿区的高度小于0.1mm时，高度不易控制，加工难度和工艺难度大，且影响上样速率。更优选地，润湿区的高度为0.25mm～0.7mm，在此范围内时，液体层流效果更好，且不易产生气泡。
通过结构设计，使样本溶液在相应的区域能够通过毛细作用流动，尤其是在最高级台阶340的顶面342与盖板100之间样本溶液能够迅速覆盖该顶面342，这样不仅可以依靠毛细作用将样本溶液全部上样至检测件，还可以显著提高上样速度，减小因多级台阶结构的截流和缓冲作用导致的样本溶液流速降低而影响上样效率的问题，提高上样效率，进而提高检测效率。
在图1～图3所示的具体示例中，当样本溶液经由多级台阶结构的截流和缓冲作用，能够基本同时到达各长条形免疫层析检测试纸条，样品垫220在接触到样本溶液后能够迅速吸收样本溶液，吸收的液体在该区域完成样本处理过程，再经过结合垫230，抗原抗体免疫结合，并带上荧光基团，流过检测膜240时，和预先绑定在上面的抗原抗体特异性结合，多余不反应的物质被吸收垫250吸收掉，在检测膜240上的检测线242聚集的荧光基团可反映出测试结果。由于多项检测时，各免疫层析检测件200的基本结构是一样的，只是上面的抗原抗体不一样，并且抗原抗体不影响吸水效果，所以保证了各免疫层析检测件200同时接触样本产生吸附时，即可等同于平均的分配样本给各免疫层析检测件200。实验测试的结果表明，上述免疫层析检测装置10的平行性的误差＜5％，所以可以满足免疫层析体外诊断检测的需求。
该免疫层析检测装置在不改变原有单个免疫层析检测件200的条件下，能直接应用原来的免疫层析检测件200，直接进行单次加样，同时进行多个项目检测。该免疫层析检测装置结构简单，易加工和制造，成本低，并且上样方便，耗时短，稳定性强，平均分配样本量的准确性高。
在其他实施例中，如图4～6所示，各安装位也可以为轴向垂直于最高级台阶640的顶面642的、两端开口的柱状孔结构，以供叠层结构的例如干化学检测试纸的免疫层析检测件700 嵌设安装，其中，上端的开口用于形成上样区，供样本溶液流入，下端的开口构成检测窗口。
该叠层结构的免疫层析检测件700包括依次层叠设置支持层710、反应层720和扩散层730。扩散层730具有上样区，反应层720含有能够与目标物质反应的反应试剂和显色剂。
具体地，反应层720包括层叠设置的试剂层721和显色层722，显色层722更靠近于支持层710。试剂层721中含有能够与目标物质反应的反应试剂，显色层722含有显色剂；或者试剂层721中含有显色剂，显色层722中含有能够与目标物质反应的反应试剂。
优选的，盖板500在对应于免疫层析检测件700的区域设有与检测腔502连通的透气孔510，以便于透气，保证检测腔502内的气压平衡，以便样本溶液顺利流动。
本发明的上样底板不限于用于对免疫层析检测件进行上样，如不限于上述长条形的免疫层析检测试纸条或者叠层结构的免疫层析干化学检测试纸，还可以为其他检测件，如电化学检测件等。通过使用盖板与上样底板配合，可以实现对不同的检测件上样的均匀性和一致性。
上述免疫层析检测装置在设计时，在上样区域增设一多级台阶结构的上样部，该上样部具有高度不同的多级台阶结构，其基准面用于承接样本溶液，盖上盖板后，样本溶液落在基准面上后，会向上流动，经过多级台阶结构的截流和缓冲作用，最终流至最高级台阶的顶面上的样本溶液能够基本同时流至各免疫层析检测件的上样区，这样多个免疫层析检测件就可以基本同时接受样本溶液，不存在时间和样本平行线上的统一问题，测试准确性高，并且只需要一次加样，检测效率高，出现误差的风险也比较小。该免疫层析检测装置在检测时，各免疫层析检测件独立检测，同时上样，相互之间不存在相互干扰，进一步有利于提高检测结果的准确性。
不仅如此，上述免疫层析检测装置在免疫层析检测件上样区的上游设置具有一定长度的润湿区，当样本溶液流至润湿区时，会形成毛细作用，推动样本溶液在润湿区流动，这样不仅可以提高样本溶液在此区域的流动速度，还可以实现不同安装位上检测件的基本同时上样，有利于提高上样的一致性和均匀性。
传统的多联卡免疫层析检测装置，因上样的不一致性差，不同安装位的免疫层析检测件难以实现同时上样，并且上样量也不均匀，导致一般只能实现三联或四联检测，无法进行五联或五联以上的检测。而使用具有上述结构的上样底板和/或控制上样底板与盖板之间的距离以在润湿区形成毛细作用，本发明的免疫层析检测装置可以实现五联、六联的上样检测，并且上样一致性好，检测结果准确性和可靠性有效提高。
请结合图7a、图7b、图8a、图8b、图9a和图9b，本发明对不同结构的上样底板的上样效果进行了对比和分析。
一、关于与检测件的上样区接触的润湿区的高度的对比和分析
以图9a和图9b所示的上样底板831为例，上样底板831不具有台阶结构，其位于加样孔下方至免疫层析检测件832的上样区之间的上样部833为平板状结构。上样部833与盖板834之间形成润湿区。
控制润湿区的高度分别为0.1mm、0.25mm、0.5mm、0.7mm、1mm、1.5mm、3mm、3.5mm、4mm和4.5mm，观察五联免疫层析检测试纸条的上样情况。
结果显示润湿区的高度在0.1mm、0.25mm、0.5mm、0.7mm、1mm、1.5mm这几个高度时，上样的一致性相对于高度3mm、3.5mm、4mm和4.5mm显著提高，尤其是当高度为0.25mm、0.5mm或0.7mm时，上样一致性更好。
拍摄视频慢镜头显示，在高度为0.1mm、0.25mm、0.5mm、0.7mm、1mm、1.5mm时，样本溶液可以在该润湿区快速流动，通过分析可认定在该区域形成了毛细作用，有利于样本溶液快速流动，因而有利于快速上样，一定程度上降低不同安装位出的检测件的上样时差。而在润湿区高度为3mm、3.5mm、4mm或4.5mm时，润湿区有气泡形成，毛细作用受影响，因而上样的一致性也受到影响。
同理，对于图1或图4、图7a和7b、图8a和8b所示的上样底板同样进行了不同高度的润湿区的实验，结果与图9a和9b所示结构的情况基本相同。
因此，可通过在检测件的上样区之前形成润湿区，并通过控制润湿区的高度，使样本溶液在进入润湿区时可以形成毛细作用来提高样本溶液的流动速度，以在一定程度上降低不同位置处的上样时差，提高上样的一致性。
二、不同结构的上样部对上样一致性的影响实验和分析
不同结构的缓冲区、润湿区及缓冲区的弧度及缓冲台阶级数对液体的平均分配的效果都有影响。图1和图4所示的上样底板300和600为本发明的一个优选方案，此设计在液体平均分配上偏差的CV值最小，小于3％，并且稳定性好，经过试验，5个免疫层析检测件中存在某1个或2个不上样的概率小于1％。
其他如图9a和图9b所示的上样底板831中，由于没有缓冲区，所以会导致5个免疫层析检测件中间的免疫层析检测件首先接触到液体，所以液体平均分配的CV偏差相对大。而如图7a和图7b所示的上样底板810方案中，基准面是弧形，相对于图1、4和9a所示的等腰三角形来说，此方案的实验结果表明，位于最外侧的两个免疫层析检测件可能会相对容易出现上不了样的情况，而三角形有利于引导液体向两端流动而避免两端液体不上样的现象出现。因此，图7a和图7b所示的上样底板810可行，但上样效果较之图1和图4所示的上样 底板300和600稍差，但显著优于图9a和图9b所示的上样底板831的上样效果。
而如图8a和图8b所示的上样底板820方案中有5个缓冲区，由于缓冲区带密集，液体向上爬坡流动的助力较大，所以可能会出现液体不能进入润湿区(即最高级台阶的顶面)的情况，出现不能上样的概率相对提高；并且由于缓冲区的深度较大，所以免疫层析检测件在吸收液体时，可能会断流，也可能会不能很好的把基准面和最低级台阶的第一级缓冲区的液体吸收完全，而部分的残留会直接影响上样的精确度。因此，图8a和图8b所示的上样底板820可行，但上样效果较之图1和图4所示的上样底板300和600稍差，但显著优于图9a和图9b所示的上样底板831的上样效果。
因而整体而言，对于上样部的结构设计，合适的缓冲区对液体的平均分配起到直接的影响作用。通过多次的模拟和实验表明图1和图4所示的方案是比较优选的，平均分配误差很小，并且出现不上样的概率极低，在一些情况下，图7a和图8a所示的方案也可行。
综上所述，可以通过控制润湿区的高度以在润湿区形成毛细作用，或者通过合适的缓冲区的结构设计来提高液体的平均分配，来提高不同安装位上的检测结构的上样一致性。优选的，可将毛细作用和合适的缓冲区的结构设计结合在一起使用，这样可以进一步提高上样效果。
可理解，对于在润湿区可形成毛细作用的检测装置，上样底板的上样部可以不限于上述图1、图4、图7a或图8a所示的台阶状结构，也可以是如图9a和图9b所示的平板状结构，这样相对于传统的检测装置，也可以一定程度上提高不同检测件的上样一致性，并且结构简单，不同的检测件之间干扰也被降低，有利于提高检测结果的准确性。对于使用毛细作用来提高上样一致性的检测装置，润湿区的高度优选不超过2mm，如可以在0.1mm～1mm之间，进一步优选在0.25mm～0.7mm之间。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (24)

  1. 一种上样底板，其特征在于，具有上样部；所述上样部为高度逐级递增的多级台阶结构，其中位于所述多级台阶结构的最底部的基准面用于承接样本溶液，所述多级台阶结构的最高级台阶具有多个用于安装检测件的安装位，相邻的所述安装位之间间隔设置。
  2. 如权利要求1所述的上样底板，其特征在于，当在所述上样部上设置能够将其覆盖的平面状盖板时，对所述基准面的靠近其前端的位置进行加样，样品溶液能够经所述多级台阶结构的截流缓冲后以基本相同的时间流至各所述安装位。
  3. 如权利要求1所述的上样底板，其特征在于，所述检测件为免疫层析试纸，且其上样区位于所述安装位上。
  4. 如权利要求1所述的上样底板，其特征在于，多个所述安装位满足如下条件中的至少一个：
    多个所述安装位的端部齐平设置；
    多个所述安装位平行设置；和
    相邻的所述安装位之间间距1mm～4mm。
  5. 如权利要求1～4中任一项所述的上样底板，其特征在于，所述基准面以及所述多级台阶结构的各级台阶的顶面均为平面结构，且所述基准面与各级台阶的顶面平行设置。
  6. 如权利要求1～4中任一项所述的上样底板，其特征在于，所述基准面呈等腰三角形，且底边与最低级台阶的侧面连接。
  7. 如权利要求6所述的上样底板，其特征在于，所述最低级台阶的顶面的长度随靠近与其连接的更高一级台阶逐渐增大。
  8. 如权利要求7所述的上样底板，其特征在于，所述最低级台阶的顶面的两端呈弧形，且两端的弧形对称设置。
  9. 如权利要求7所述的上样底板，其特征在于，中间各级台阶与最高级台阶的顶面的各处长度保持一致。
  10. 如权利要求7～9中任一项所述的上样底板，其特征在于，最高级台阶的侧面呈对称的弧面状，且该弧面状的侧面从两端至中间向基准面所在端逐渐凸出。
  11. 如权利要求10所述的上样底板，其特征在于，所述上样部为三级台阶结构。
  12. 一种免疫层析检测装置，其特征在于，包括盖板、免疫层析检测件以及如权利要求1～11中任一项所述的上样底板；所述盖板与所述上样底板配合围成检测腔，所述上样部位于 所述检测腔内；所述盖板对应于所述上样部的基准面设有加样孔；所述免疫层析检测件有多个，多个所述免疫层析检测件的上样区分别对应安装在多个所述安装位上。
  13. 如权利要求12所述的免疫层析检测装置，其特征在于，所述加样孔靠近于所述基准面的远离最低级台阶的一端。
  14. 如权利要求12或13所述的免疫层析检测装置，其特征在于，所述加样孔的轴向相对于所述盖板倾斜设置。
  15. 如权利要求12或13所述的免疫层析检测装置，其特征在于，所述加样孔从入口端至出口端内径逐渐减小。
  16. 如权利要求12或13所述的免疫层析检测装置，其特征在于，所述盖板与所述上样部之间的间距满足：当样本溶液流至所述上样部的最高级台阶的顶面与所述盖板之间的空间时，样本溶液能够在毛细作用的推动下沿所述上样部的表面向所述免疫层析检测件的上样区所在位置流动。
  17. 如权利要求16所述的免疫层析检测装置，其特征在于，所述上样部的最高级台阶的顶面与所述盖板之间的距离不大于2mm。
  18. 如权利要求12、13或17所述的免疫层析检测装置，其特征在于，各所述安装位为沿所述最高级台阶的顶面延伸的长条形的槽状结构，以供长条形的免疫层析检测件嵌设安装。
  19. 如权利要求18所述的免疫层析检测装置，其特征在于，所述免疫层析检测件包括基底和设在所述基底上且从所述基底的一端至另一端顺次连接的样品垫、结合垫、检测膜及吸收垫，所述样品垫具有所述上样区，所述检测膜具有检测线。
  20. 如权利要求19所述的免疫层析检测装置，其特征在于，所述盖板上设有用于观察各所述免疫层析检测件的检测线的检测窗口。
  21. 如权利要求12、13或17所述的免疫层析检测装置，其特征在于，各所述安装位为轴向垂直于所述最高级台阶的顶面的、两端开口的柱状孔结构，以供叠层结构的免疫层析检测件嵌设安装，其中，上端的开口用于供样本溶液流入至所述上样区，下端的开口构成检测窗口。
  22. 如权利要求21所述的免疫层析检测装置，其特征在于，所述免疫层析检测件包括依次层叠设置支持层、反应层和扩散层，所述扩散层具有所述上样区，所述反应层含有能够与目标物质反应的反应试剂和显色剂。
  23. 如权利要求22所述的免疫层析检测装置，其特征在于，所述反应层包括层叠设置的试剂层和显色层，所述显色层更靠近于所述支持层；
    所述试剂层中含有能够与目标物质反应的反应试剂，所述显色层含有显色剂；或者所述试剂层中含有显色剂，所述显色层中含有能够与目标物质反应的反应试剂。
  24. 如权利要求22或23所述的免疫层析检测装置，其特征在于，所述盖板在对应于所述免疫层析检测件的区域设有与所述检测腔连通的透气孔。
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