WO2016061810A1 - 用于免疫层析检测的装置 - Google Patents

用于免疫层析检测的装置 Download PDF

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Publication number
WO2016061810A1
WO2016061810A1 PCT/CN2014/089429 CN2014089429W WO2016061810A1 WO 2016061810 A1 WO2016061810 A1 WO 2016061810A1 CN 2014089429 W CN2014089429 W CN 2014089429W WO 2016061810 A1 WO2016061810 A1 WO 2016061810A1
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WO
WIPO (PCT)
Prior art keywords
cup
cup body
housing
tip
protrusion
Prior art date
Application number
PCT/CN2014/089429
Other languages
English (en)
French (fr)
Inventor
朱海
Original Assignee
朱海
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 朱海 filed Critical 朱海
Priority to US15/325,604 priority Critical patent/US10436782B2/en
Priority to ES14904306T priority patent/ES2808609T3/es
Priority to EP14904306.9A priority patent/EP3211419B1/en
Priority to CN201490000201.5U priority patent/CN206348339U/zh
Priority to PCT/CN2014/089429 priority patent/WO2016061810A1/zh
Publication of WO2016061810A1 publication Critical patent/WO2016061810A1/zh

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Classifications

    • 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
    • G01N33/558—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
    • 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
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/02—Adapting objects or devices to another
    • B01L2200/026—Fluid interfacing between devices or objects, e.g. connectors, inlet details
    • 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
    • B01L2300/044—Connecting closures to device or container pierceable, e.g. films, membranes
    • 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
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0672—Integrated piercing tool
    • 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
    • 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
    • B01L2400/0457—Moving fluids with specific forces or mechanical means specific forces passive flow or gravitation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L7/00—Heating or cooling apparatus; Heat insulating devices

Definitions

  • the application belongs to the technical field of immunochromatography detection and relates to a device for immunochromatographic detection.
  • Immunochromatography is a rapid detection/diagnostic technique, which can be divided into two methods: sandwich immunochromatography and competitive immunochromatography.
  • sandwich immunoassay is: firstly fix a specific antibody to a certain zone (line) of a nitrocellulose membrane (ie, a chromatographic membrane) in a test paper, and immerse one end of the sample pad in the test paper into the liquid sample.
  • a nitrocellulose membrane ie, a chromatographic membrane
  • the sample will move along the nitrocellulose membrane to the other end under capillary action, when moving to the zone (line) where the antibody is immobilized
  • a liquid sample such as urine, serum, milk, etc.
  • the sample will move along the nitrocellulose membrane to the other end under capillary action, when moving to the zone (line) where the antibody is immobilized
  • the corresponding antigen in the sample specifically binds to the antibody, and then the region is displayed with a certain color or fluorescence by immunocolloidal gold, immunoenzymatic staining or immunofluorescence technology, thereby realizing specific immunodiagnosis and detection.
  • the principle of competitive immunochromatography for small molecule detection can be divided into two cases as follows: when immobilized on a nitrocellulose membrane is a small molecule conjugate, the small molecule to be tested After binding of the free antibody, the binding prevents the free antibody from binding to the small molecule conjugate on the nitrocellulose membrane, ie, the competition between the small molecule to be tested and the small molecule conjugate on the nitrocellulose membrane and the free antibody
  • the opportunity for binding when immobilized on a nitrocellulose membrane is a specific antibody, the small molecule to be tested competes with the free labeled small molecule for the opportunity to bind to a specific antibody immobilized at a specific region on the nitrocellulose membrane.
  • the presence or absence of the analyte is then determined by the attenuation or disappearance of the color or fluorescence exhibited by the region to which the small molecule conjugate or specific antibody is immobilized.
  • a conventional immunochromatographic test strip made by this technique usually consists of a backing and a sample pad adhered to the backing, a bonding pad (marker binding pad), a cellulose film, an absorbent pad, and the like.
  • the sample is dropped onto the sample pad, and the sample is transferred by capillary action on the chromatography strip in the sample pad.
  • the sample specifically reacts with the label on the binding pad to produce an immune complex; the immune complex continues to migrate and specifically binds to the corresponding antigen/antibody in the monitored area on the cellulose membrane to form a visible or Detectable strips.
  • the traditional reaction mode immunochromatographic test strip is generally in the form of a buckle, which is inconvenient to terminate the reaction by removing the sample pad, and it is easy to make a large error in the result due to different reaction time during observation;
  • Improved immunochromatographic test strips have been used to overcome the above disadvantages, for example, cuvettes (micropores) + Test strip mode, which has no sample pad/bond pad.
  • the improved immunochromatographic test strip has more advantages than the test strip of the conventional reaction mode, but there are still many disadvantages in that the operation steps are numerous and the use is troublesome.
  • one test requires 5 steps to complete: 1, add the sample to the reaction cup, mix; 2, incubate the reaction cup for a period of time; 3, insert the test strip, react on the incubator for a period of time; 4, remove the test strip Strip, remove the sample pad to terminate the reaction; 5, put the reader into the reading, read the results.
  • Such cumbersome steps are unfavorable for the efficiency and simplicity of rapid on-site detection, especially for clinical testing. It is therefore desirable to provide a device that enables rapid immunochromatographic detection.
  • the purpose of the present application is to provide an apparatus for immunochromatographic detection, which aims to solve the problem of cumbersome detection steps and long detection period in the prior art.
  • an apparatus for immunochromatographic detection comprising a housing and a cup body located inside the housing, the housing including an upwardly extending hollow protrusion for receiving a cup body
  • the cup body includes a cup body wall and a bottom of the cup body, and a convex tip is disposed below the bottom of the cup body in the housing, and the cup body and the tip end of the protrusion can move toward each other, and the protrusion is moved during the movement
  • the tip will break the bottom of the cup while releasing the liquid contained in the cup, in which a fence is provided below the bottom of the cup and includes an annular structure corresponding to the outer circumference of the bottom of the cup and a groove communicating therewith.
  • Another embodiment of the present application provides an apparatus for immunochromatographic detection, wherein a protrusion is provided in a communication between the annular structure and the groove in the fence for fixing the test strip together with the groove.
  • Another embodiment of the present application further provides an apparatus for immunochromatographic detection, wherein a portion of the bottom of the casing in the annular structure of the fence is a slope structure, and the connection between the annular structure and the groove is a slope structure. The bottom part of the slope.
  • Another embodiment of the present application also provides an apparatus for immunochromatographic detection, wherein the hollow protrusion is screwed to the cup.
  • Another embodiment of the present application further provides a device for immunochromatographic detection, wherein the top of the cup wall is provided with two or more outwardly extending protrusions through which a torsional external force can be applied to the cup body.
  • the cup is moved toward the raised tip of the housing, thereby damaging the bottom of the cup and releasing the liquid in the cup through the raised tip.
  • Another embodiment of the present application further provides a device for immunochromatographic detection, wherein the hollow protrusion and the inner cup are connected to the chute through a guide rail, and two or more chutes are disposed inside the hollow protrusion.
  • the outer side of the cup body is provided with a guide rail corresponding to the sliding groove, and by applying downward pressure to the cup body, the cup body can be moved along the guide rail toward the protruding tip end to break the bottom of the cup body and release the liquid in the cup body.
  • Another embodiment of the present application also provides an apparatus for immunochromatographic detection, wherein the cup is connected to the hollow protrusion by two or more hang buckles located outside the bottom.
  • Another embodiment of the present application further provides an apparatus for immunochromatographic detection, wherein the housing comprises a face shell, a bottom shell and a pressure plate shell, the hollow protrusion is located on the surface shell, and the fence is located on the bottom shell, a raised tip is located on the platen housing, and a hole corresponding to the tip end of the protrusion is disposed in the annular structure of the fence, the tip of the protrusion is engaged with the hole when the tip end of the protrusion breaks the bottom of the cup It prevents liquid leakage.
  • the housing comprises a face shell, a bottom shell and a pressure plate shell
  • the hollow protrusion is located on the surface shell
  • the fence is located on the bottom shell
  • a raised tip is located on the platen housing
  • a hole corresponding to the tip end of the protrusion is disposed in the annular structure of the fence, the tip of the protrusion is engaged with the hole when the tip end of the protrusion breaks the bottom of the cup It prevents liquid leakage.
  • Another embodiment of the present application further provides a device for immunochromatographic detection, wherein the bottom shell and the pressure shell plate are connected by a support bone, and the pressure shell plate can pivotally move around the support bone, This causes the raised tip to break the bottom of the cup and release the liquid in the cup.
  • the apparatus for immunochromatographic detection provided by the present application can automatically realize the "reaction cup” (micropore) in the prior art by simply adding the sample to the reaction cup, mixing it, and using the matching detection instrument. ) + The test strip mode "requires a 5-step operation to complete the detection process, thus shortening the detection time.
  • the detection means has the same sensitivity detection effect. Therefore, the apparatus for immunochromatographic detection of the present application retains all advantages over the conventional detection mode, while avoiding the disadvantages of having many operation steps and cumbersome use.
  • FIG. 1 is a perspective view of an apparatus for immunochromatographic detection according to an embodiment of the present application.
  • FIG. 2 is a top plan view of a bottom shell portion of an apparatus for immunochromatographic detection, in accordance with one embodiment of the present application;
  • FIG. 3 is a cross-sectional view of an apparatus for immunochromatographic detection, in accordance with one embodiment of the present application.
  • FIG. 4 is a cross-sectional view of a hollow protrusion structure portion of an apparatus for immunochromatographic detection according to an embodiment of the present application
  • FIG. 5 is a perspective view of an apparatus for immunochromatographic detection in accordance with another embodiment of the present application.
  • FIG. 6 is a cross-sectional view of an apparatus for immunochromatographic detection in accordance with another embodiment of the present application.
  • Figure 7 is a cross-sectional view showing a hollow projection structure portion of an apparatus for immunochromatographic detection according to another embodiment of the present application.
  • FIG. 8 is an exploded perspective view of an apparatus for immunochromatographic detection according to another embodiment of the present application.
  • FIG. 9 is a perspective view of an apparatus for immunochromatographic detection according to another embodiment of the present application.
  • Figure 10 is a perspective view of a pressure plate of an apparatus for immunochromatographic detection according to another embodiment of the present application.
  • Figure 11 is a cross-sectional view of an apparatus for immunochromatographic detection in accordance with another embodiment of the present application.
  • Embodiments of the present application provide an apparatus for immunochromatographic detection, comprising a housing and a cup located inside the housing.
  • the housing includes an upwardly extending hollow protrusion for receiving a cup, the cup being separable from the housing, the cup including a cup wall and a cup bottom, the cup body can contain a liquid reagent, or contain The powder reagent is added to the liquid sample as it is being tested.
  • a raised tip and a fence surrounding the tip of the protrusion are disposed in the housing below the bottom of the cup, wherein the tip of the protrusion may or may not be in contact with the bottom of the cup, and the protrusion
  • the tip can move toward the cup, and by moving the tip of the projection, the bottom of the cup is simultaneously released to release the liquid contained in the cup, and the liquid contained in the cup is completely released.
  • the fence surrounding the raised tip includes an annular structure corresponding to the outer circumference of the bottom of the cup and a slot communicating therewith, wherein the annular structure is for receiving the liquid released from the cup and contacting it with the test strip, and The connected slots are used to place test strips.
  • the mixing and reaction of the liquid can be completed in the cup body, and then the liquid in the cup body is released from the bottom of the cup body by the protruding tip, and all flows to the fence below the cup body, and the fence accommodates All of the liquid, and these liquids are in contact with one end of the test strip, and are moved toward the other end of the test strip by capillary action, thereby completing the detection.
  • a protrusion is provided at a communication between the annular structure of the fence and the groove, and the protrusion is used to fix the test strip together with the groove, so that the test strip Firmly positioned in the slot.
  • the portion of the casing in the annular structure of the fence is a slope structure, wherein the communication between the annular structure and the groove is the slope bottom portion of the slope structure because One end of the test strip is disposed at the bottom portion of the slope, and the arrangement allows the liquid flowing down from the cup to completely flow to the test strip.
  • An observation window is also included in the housing of the apparatus for immunochromatographic detection of the present application.
  • the apparatus for immunochromatographic detection of the present application can move the tip of the projection and the cup toward each other in a variety of ways.
  • the raised tip is secured in the housing such that the cup moves toward the raised tip, thereby damaging the bottom of the cup to release liquid.
  • the cup and the hollow projection can be engaged by means of a thread and can be carried by the thread when moved relatively.
  • two or more protrusions are disposed on the outer side of the top of the cup body, and an external force can be applied to the cup body by the external device to rotate, thereby causing the cup body to move along the thread toward the tip end of the protrusion and utilize the The tip destroys the bottom of the cup.
  • positioning ribs are also provided in the fence for defining the distance by which the cup moves downward.
  • the cup body and the hollow protrusion may be connected to the sliding groove through the rail, for example, two or more protruding rails are disposed outside the cup body, and a corresponding number of slips corresponding thereto are disposed inside the hollow protrusion A slot that can move in the chute.
  • downward pressure can be applied to the cup, and the cup moves along the chute toward the pointed tip and uses the tip to break the bottom of the cup.
  • timing Prior to piercing the bottom of the cup, timing can be performed using an external device so that the liquid in the cup reacts sufficiently, and then a twisting force or pressure is applied to the cup to break the bottom of the cup through the raised tip, thereby releasing the liquid in the cup.
  • the cup body is relatively fixed to the hollow protrusion, and when detected, the tip end of the protrusion is moved toward the cup body to break the bottom of the cup body.
  • This solution can be accomplished by adding a pressure plate.
  • the housing of the device comprises a face shell, a bottom shell and a pressure plate shell, the hollow protrusion is located on the surface shell, the fence is located in the bottom shell, the protruding tip is located on the pressure plate shell, and the annular structure of the fence is arranged There is a hole corresponding to the pointed tip.
  • the pressure shell plate and the bottom shell are connected by two supporting bones (short rods) located in the groove, whereby the pressure shell plate can rotate around the supporting bone, and the movement of the protruding tip can pass through the pressing shell
  • the opposite end of the tip applies pressure to complete.
  • a hole corresponding to the tip end of the protrusion is disposed in the bottom surface surrounded by the annular structure of the bottom case, and the tip can prevent liquid leakage between the tip and the hole when the tip passes through the hole and breaks the bottom of the cup body to release the liquid. That is to say, the liquid flowing out of the cup is completely held in the fence and does not penetrate under the fence, which makes the detection process more precise.
  • the present application provides a device 1 for immunochromatographic detection, comprising a cup 11, a housing 12, wherein the housing 12 includes an upwardly extending hollow protrusion 121 and an observation window 122,
  • the hollow protrusion 121 is for accommodating the cup body 11.
  • the test strip 13 is located in the housing 12 and the test strip 13 can be viewed through the viewing window 122.
  • the cup 11 and the hollow projection 121 of the housing 12 are threaded.
  • the cup body 11 includes two protrusions 111.
  • the number of the protrusions 111 may be two or more than two.
  • the housing 12 can include two parts, a face shell and a bottom case.
  • Figure 1 shows the structure in which the face shell and the bottom case are combined.
  • Figure 2 shows the structure of the bottom case.
  • the bottom case includes an annular structure 123 and is in communication therewith. groove 127, the ring structure 123 is provided with a positioning rib 124 and a protrusion 125, the protrusion 125 is located at the intersection of the ring structure 123 and the groove 127, the test strip 13 is placed in the groove 127, and the groove 127 and the protrusion 125 co-locate the test paper Article 13.
  • FIG. 3 is a cross-sectional view of the apparatus 1 for immunochromatographic detection of the present application in the longitudinal direction of the test strip 13
  • FIG. 4 is a schematic cross-sectional view showing the junction of the hollow protrusion 121 and the cup 11.
  • Cup The top outer side of the 11 includes two protrusions 111 in which a raised tip 126 is disposed below the cup 11.
  • the cup 11 By applying a torsional force to the two protrusions 111 on the outer side of the top of the cup, the cup 11 is opposite the housing along the thread
  • the hollow protrusion 121 of 12 moves toward the convex tip 126, and the raised tip 126 breaks the bottom of the cup 11 and releases the liquid in the cup 11.
  • FIGS 5-7 illustrate another embodiment of the apparatus of the present application.
  • the outer side of the cup body 11 is provided with a protruding rail 113.
  • the hollow protrusion 121 of the housing 12 is correspondingly provided with a sliding slot.
  • the protruding rail is located in the sliding slot, and the number of the rail and the sliding slot can be two or more. In two.
  • the cup 11 By applying pressure to the cup 11, the cup 11 can be along the hollow protrusion
  • the chute in 121 moves downward, thereby breaking the bottom of the cup 11 with the raised tip 126 in the housing 12 and releasing the liquid in the cup 11, which liquid all flows into the annular structure 123 and with the test strip Strip contact, thereby detecting.
  • the housing 12 further includes a pressure plate disposed outside the bottom case, as shown in FIG.
  • the hollow protrusion 121 is located in the face shell
  • the annular structure 123 is located in the bottom case
  • a hole corresponding to the pointed end 126 of the protrusion is provided in a plane surrounded by the annular structure 123
  • the raised tip 126 Located in the shell plate.
  • two hooks 8 are provided on the outer side of the bottom of the cup body 11 for relatively fixing the cup body 11 and the hollow protrusions 121.
  • the raised tip 126 is caused to move toward the cup 11 and break the bottom of the cup 11.
  • FIG. 8 two hooks 8 are provided on the outer side of the bottom of the cup body 11 for relatively fixing the cup body 11 and the hollow protrusions 121.
  • the pressure plate includes two supporting bones 128, and two recesses are correspondingly arranged in the bottom shell, and the supporting bones 128 are disposed in the grooves, thereby pressing the shell and the bottom shell Relatively fixed.
  • the compression shell can be rotated about the support bone 128 such that the raised tip 126 can move toward the cup 11 and break the bottom of the cup, thereby releasing the liquid in the cup.
  • a non-slip strip may be provided at the end of the supporting bone, as shown in Figs.
  • the protrusion 111 provided on the cup body 11 is rotated by 180° by the supporting detecting instrument, so that the protruding tip 126 of the casing 12 breaks the bottom of the cup body 11 to allow the liquid after the reaction. Released into the annular structure 123, and infiltrated into the test strip to achieve its reaction with the test strip, in which the supporting test instrument still provides the temperature required for the reaction;
  • step (3) a pressure is applied to the cup 11 by means of a matching detecting instrument, so that the raised tip 126 of the housing 12 breaks the bottom of the cup 11
  • step (3) a pressure is applied to the cup 11 by means of a matching detecting instrument, so that the raised tip 126 of the housing 12 breaks the bottom of the cup 11
  • step (3) an external force is applied to the pressure plate, so that the convex tip 126 at the other end of the pressure plate moves upward, and the bottom of the cup 11 is broken. Same as above.
  • the housing of the device of the present application may be provided with a barcode, a two-dimensional code, etc., and the related information is read by the supporting detection instrument, wherein the information of the barcode, the two-dimensional code, etc. may include the test item, the detection result of the batch test card product is corrected.
  • the device of the present application is simultaneously tested with a conventional detecting device for detecting chloramphenicol residues in milk (raw milk), and is compared in terms of detection cycle, sensitivity, precision, and accuracy.
  • the test is divided into three groups:
  • Group A detection device of the present application
  • the detection device of the present application is consistent with the conventional method in terms of sensitivity, precision and accuracy, and at the same time, the detection cycle is significantly shortened compared with the existing method.

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Abstract

一种用于免疫层析检测的装置（1），包括壳体（12）和杯体（11），壳体（12）包括向上延伸的中空突起（121）用于容纳杯体（11），杯体（11）包括杯体壁和杯体底部，在壳体（12）中设置有凸起的尖端（126）和围绕尖端（126）的围栏，杯体（11）与凸起的尖端（126）可以相向移动由此凸起的尖端（126）能够破坏杯体底部并使杯体（11）中的液体释放出来。

Description

用于免疫层析检测的装置 技术领域
本申请属于免疫层析检测技术领域，涉及一种用于免疫层析检测的装置。
 背景技术
免疫层析技术是一种快速检测/诊断技术，主要可分为夹心法免疫层析检测和竞争法免疫层析检测两种情况。其中夹心法免疫检测的原理为：将特异的抗体先固定于试纸中硝酸纤维素膜等（即层析膜）的某一区带（线）处，当试纸中的样品垫一端浸入液体样品中或在其一端加入液体样品（如尿液、血清、牛奶等）后，在毛细管作用下，样品将沿着硝酸纤维素膜向另一端移动，当移动至固定有抗体的区带（线）时，样品中相应的抗原即与该抗体发生特异性结合，然后利用免疫胶体金、免疫酶染色或免疫荧光技术可使该区域显示一定的颜色或发出荧光，从而实现特异性的免疫诊断和检测。另一方面，针对小分子检测的竞争法免疫层析技术的原理可分为两种情况简述如下：当固定于硝酸纤维素膜上的是小分子偶联物时，在待测小分子与游离抗体结合后，该结合使得该游离抗体不能与硝酸纤维素膜上的小分子偶联物结合，即，待测小分子与硝酸纤维素膜上的小分子偶联物之间竞争与游离抗体结合的机会；当固定于硝酸纤维素膜上的是特异性抗体时，待测小分子与游离的标记小分子竞争与固定于硝酸纤维素膜上特定区带处的特异性抗体结合的机会。然后通过该固定有小分子偶联物或特异性抗体的区域显示出的颜色或荧光的减弱或消失，来确定待测物是否存在。
上述检测过程中，对颜色或荧光的观察或判断可以通过肉眼或检测仪器进行，可实现定性、半定量和定量判断。目前，免疫层析技术及以此为基础的试纸条产品已在医学检测、食品安全检测等领域得到广泛应用。
利用该技术制成的传统免疫层析试纸条通常由以下几部分组成：背衬及粘贴在背衬上的样品垫、结合垫（标记物结合垫）、纤维素膜、吸收垫等。进行检测时，将样品滴加到样品垫上，样品会通过毛细作用在样品垫中的层析条上迁移。在迁移的过程中，样品与结合垫上的标记物发生特异性反应，产生免疫复合物；该免疫复合物继续迁移，与纤维素膜上监测区域的相应抗原/抗体发生特异性结合，形成可见或可检测的条带。
上述传统反应模式免疫层析试纸条通常存在以下技术弊端：
（1）以浸泡或喷雾方式制备的结合垫在干燥过程中，由于“边缘效应”的作用，使得结合垫上的标记物等试剂分布不均；
（2）样品流经样品垫和结合垫时，由于液体的流动方式和流过时间存在一定的随机性（特别在卡扣存在时），导致从结合垫上释放并进入反应的试剂量存在一定随机差异；
（3）环境温度变化对反应有一定影响；
（4）传统反应模式免疫层析试纸条一般为带卡扣形式，不方便通过去除样品垫的方式终止反应，容易在观测时因反应时间不同而使结果有较大误差；
（5）肉眼判断结果时，易受环境照明、个人视觉、个人对判断标准把握的不同产生差异。
以上技术弊端会导致或加剧结果的误差，特别在使用该技术进行定量和半定量检测时。
目前已有改进的免疫层析试纸条用于克服上述缺点，例如，反应杯（微孔） + 试纸条模式，此种模式无样品垫/结合垫。该改进的免疫层析试纸条相对于传统反应模式的试纸条有较多优势，但仍然存在操作步骤多，使用较麻烦的缺点。通常一次检测需要5个步骤来完成：1、加样品到反应杯中，混匀；2、孵育反应杯一段时间；3、插入试纸条，在孵育器上反应一段时间；4、取出试纸条，去除样品垫终止反应；5、放入读数仪，读取结果。这样繁琐的操作步骤，对现场快速检测的效率和简便性是不利的，特别是对于临床检测尤其明显。因此需要提供一种能进行快速免疫层析检测的装置。
 技术问题
本申请的目的在于提供一种用于免疫层析检测的装置，旨在解决现有技术中检测步骤繁琐，检测周期较长的问题。
 技术解决方案
本申请实施例是这样实现的，一种用于免疫层析检测的装置，包括壳体和位于壳体内部的杯体，该壳体包括向上延伸的中空突起，该中空突起用于容纳杯体，该杯体包括杯体壁和杯体底部，在该壳体中在杯体底部下方设置有凸起的尖端，该杯体与凸起的尖端可以相向移动，在移动过程中该凸起的尖端将破坏该杯体底部同时释放杯体中容纳的液体，在该壳体中在杯体底部下方还设置有围栏，并包括与杯体底部外圆周对应的环形结构以及与之连通的槽。
本申请另一实施例提供一种用于免疫层析检测的装置，其中，在该围栏中该环形结构与槽的连通处设置有凸起，用于与槽一起固定试纸条。
本申请另一实施例还提供一种用于免疫层析检测的装置，其中，该壳体底部在围栏的环形结构中的部分为坡面结构，该环形结构与槽的连通处为坡面结构的坡底部分。
本申请另一实施例还提供一种用于免疫层析检测的装置，其中，该中空突起与杯体通过螺纹连接。
本申请另一实施例还提供一种用于免疫层析检测的装置，其中，该杯体壁顶部设置有两个以上向外延伸的突出部，通过所述突出部可以向杯体施加扭转外力，使杯体向壳体中凸起的尖端移动，由此通过凸起的尖端破坏杯体的底部并释放杯体中的液体。
本申请另一实施例还提供一种用于免疫层析检测的装置，其中，该中空突起与内部的杯体通过导轨与滑槽进行连接，该中空突起内侧设置有两个以上的滑槽，杯体外侧设置有与所述滑槽对应的导轨，通过向该杯体施加向下的压力可以使杯体沿着导轨向凸起的尖端移动以此破坏杯体底部并释放杯体中的液体。
本申请另一实施例还提供一种用于免疫层析检测的装置，其中，该杯体通过位于底部外侧的两个以上的挂扣与中空突起连接。
本申请另一实施例还提供一种用于免疫层析检测的装置，其中，该壳体包括面壳、底壳和压板壳，该中空突起位于面壳上，该围栏位于底壳上，该凸起的尖端位于压板壳上，且在围栏的环形结构中设置有与凸起的尖端对应的孔，该凸起的尖端穿过该孔破坏杯体底部时该凸起的尖端和该孔接合处能防止液体渗漏。
本申请另一实施例还提供一种用于免疫层析检测的装置，其中，该底壳与该压壳板通过支力骨连接，该压壳板能围绕支力骨进行枢转运动，由此使得凸起的尖端破坏杯体底部并释放杯体中的液体。
 有益效果
本申请提供的用于免疫层析检测的装置在使用过程中，只需将样品加到反应杯中、混匀后，通过配套的检测仪器，可以自动实现现有技术中“反应杯（微孔） + 试纸条模式”需要5步操作来完成的检测过程，因此缩短了检测时间。同时通过对比实施例的验证，可以看出本申请的用于免疫层析检测的装置可以获得与现有技术中的检测手段同样灵敏度的检测效果。因此，本申请的用于免疫层析检测的装置相对传统检测模式保留了全部优势，同时又避免了其操作步骤多，使用较麻烦的缺点。
 附图说明
图1为根据本申请一个实施例的用于免疫层析检测的装置的立体图；
图2为根据本申请一个实施例的用于免疫层析检测的装置的底壳部分的俯视图；
图3为根据本申请一个实施例的用于免疫层析检测的装置的剖视图；
图4为根据本申请一个实施例的用于免疫层析检测的装置的中空突起结构部分的剖视图；
图5为根据本申请另一个实施例的用于免疫层析检测的装置的立体图；
图6为根据本申请另一个实施例的用于免疫层析检测的装置的剖视图；
图7为根据本申请另一个实施例的用于免疫层析检测的装置的中空突起结构部分的剖视图；
图8为根据本申请另一个实施例的用于免疫层析检测的装置的分解示意图；
图9为根据本申请另一个实施例的用于免疫层析检测的装置的立体图；
图10为根据本申请另一个实施例的用于免疫层析检测的装置的压壳板的立体图；
图11为根据本申请另一个实施例的用于免疫层析检测的装置的剖面图。
 本发明的实施方式
为了使本申请要解决的技术问题、技术方案及有益效果更加清楚明白，以下结合附图及实施例，对本申请进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本申请，并不用于限定本申请。
本申请实施例提供一种用于免疫层析检测的装置，包括壳体和位于壳体内部的杯体。该壳体包括向上延伸的中空突起，该中空突起用于容纳杯体，该杯体可与壳体分离，该杯体包括杯体壁和杯体底部，杯体中可容纳液体试剂，或者含有粉末试剂并在进行检测时加入液体样品。在壳体中位于杯体底部的下方设置有凸起的尖端及围绕该凸起的尖端的围栏，其中凸起的尖端可以与杯体底部接触，也可以不与之接触，且该凸起的尖端可以与杯体相向移动，通过移动该凸起的尖端将顶破杯体底部同时释放杯体中容纳的液体，此时杯体中容纳的液体完全释放出来。围绕凸起的尖端的围栏包括与杯体底部外圆周对应的环形结构以及与之连通的槽，其中环形结构用于容纳杯体中释放出的液体并使其与检测试纸条接触，而与之连通的槽用于放置检测试纸条。
利用本申请的装置，可以在杯体中完成液体的混合和反应，然后通过凸起的尖端破坏杯体底部释放杯体中的液体，使其全部流向杯体下面的围栏中，该围栏中容纳全部液体，并且这些液体与检测试纸条的一端接触，利用毛细管作用向试纸条另一端移动，由此完成检测。这与传统的多步检测方法相比减少了加样步骤，缩短了检测时间，提高了检测效率。
在优选实施例中，本申请的用于免疫层析检测的装置中，在围栏的环形结构与槽的连通处设置有凸起，该凸起用于与槽一起固定试纸条，使得试纸条牢固地定位于槽中。
优选地，本申请的用于免疫层析检测的装置中，壳体中在围栏的环形结构中的部分为坡面结构，其中环形结构与槽的连通处为坡面结构的坡底部分，因为试纸条的一端设置于坡底部分，此种设置可以使得从杯体中流下的液体能完全流向试纸条。
本申请的用于免疫层析检测的装置的壳体中还包括观察窗。
本申请的用于免疫层析检测的装置可以采用多种方式使得凸起的尖端和杯体相向移动。根据一个实施例，将凸起的尖端固定于壳体中，使得杯体向凸起的尖端移动，由此来破坏杯体底部释放液体。杯体与中空突起可以利用螺纹进行接合，且在相对移动时可通过该螺纹进行。此种情况下杯体顶部外侧设置有两个或多个突起，可以利用外部设备通过这些突起对杯体施加外力使其旋转，由此使得杯体沿着螺纹向凸起的尖端移动并利用该尖端破坏杯体底部。该实施例中在围栏中还设有定位筋用于限定杯体向下移动的距离。
根据另一实施例，杯体可与中空突起通过轨道与滑槽进行连接，例如，杯体外侧设置有两个或多个突出的轨道，在中空突起内侧设置有与之对应的相应数量的滑槽，该突出的轨道可在滑槽中移动。利用外部设备可以向杯体施加向下压力，杯体沿着滑槽向凸起的尖端移动并利用该尖端破坏杯体底部。
在刺破杯体底部之前，可以利用外部设备进行定时，以便杯体内液体充分反应，之后向杯体施加扭转力或压力以通过凸起的尖端破坏杯体底部，从而释放杯体中的液体。
根据本申请另一实施例，杯体与中空突起相对固定，检测时使凸起的尖端向杯体移动，从而破坏杯体底部。该方案可通过增设压壳板来完成。此种情况下，该装置的壳体包括面壳、底壳和压板壳，中空突起位于面壳上，围栏位于底壳中，凸起的尖端位于压板壳上，同时该围栏的环形结构中设置有与凸起的尖端对应的孔。压壳板与底壳通过两个位于凹槽中的支力骨（短棒）连接，由此压壳板能围绕支力骨旋转运动，凸起的尖端的移动可通过向压壳板的与该尖端相对的另一端施加压力来完成。底壳的环形结构中包围的底面中设置有与凸起的尖端对应的孔，在该尖端穿过该孔并破坏杯体底部以释放液体时，该尖端与孔之间能防止液体渗漏，也就是说，使得杯体中流出的液体完全保持于围栏中，不会渗透到围栏下方，这使得检测过程更加精确。
以下通过具体实施例对本申请进行进一步解释。
如图1、5和9所示，本申请提供一种用于免疫层析检测的装置1，包括杯体11，壳体12，其中壳体12包括向上延伸的中空突起121和观察窗122，该中空突起121用于容纳杯体11。试纸条13位于壳体12中，可通过观察窗122观察到试纸条13。图1-4显示的实施例中杯体11和壳体12的中空突起121通过螺纹连接。如图1所示，杯体11中包括两个突起111。突起111的数量可为两个，也可以多于两个。可利用外部设备通过该突起111对杯体11施加扭转力，使得杯体11沿着螺纹向凸起的尖端移动。该壳体12可包括面壳和底壳两部分，图1显示出了面壳与底壳结合在一起的结构，图2为底壳的结构，底壳包括环形结构123，以及与之连通的槽 127，环形结构123中设置有定位筋124和凸起125，凸起125位于环形结构123与槽127的连通处，试纸条13放置于槽127中，槽127与凸起125共同定位试纸条13。定位筋124可以限制杯体11的运动距离，从而在环形结构123中保持足够的空间容纳反应液体。图3显示了本申请的用于免疫层析检测的装置1沿试纸条13纵向方向的剖面图，图4显示出了中空突起121与杯体11连接处的剖面示意图。杯体 11顶部外侧包括两个突起111，壳体12中在杯体11下方设置有凸起的尖端126。通过向杯体顶部外侧两个突起111施加扭转力，使得杯体11沿着螺纹相对与壳体 12的中空突起121向凸起的尖端126移动，凸起的尖端126破坏杯体11的底部并使杯体11中的液体释放出来。
图5-7显示了本申请的装置的另一实施例。该实施例中，杯体11外侧设置有突出的导轨113，壳体12的中空突起121中对应设置有滑槽，突出的导轨位于滑槽中，导轨和滑槽的数量可以为两个或多于两个。本实施例中示意性地显示出杯体11外侧设置有两个导轨113。通过向杯体11施加压力，杯体11可沿中空突起 121中的滑槽向下移动，由此利用壳体12中的凸起的尖端126将杯体11底部破坏，并释放杯体11中的液体，该液体全部流入环形结构123中并与试纸条接触，由此进行检测。
图8-11显示了本申请的装置的另一实施例。本实施例中，壳体12还包括设置于底壳外部的压壳板，如图9所示。如图8和10所示，中空突起121位于面壳中，环形结构123位于底壳中，且环形结构123中包围的平面中设置有与凸起的尖端126对应的孔，凸起的尖端126位于压壳板中。如图8所示，杯体11底部外侧设置有两个挂扣8，用于使杯体11与中空突起121相对固定。该实施例中，使得凸起的尖端126向杯体11移动并破坏杯体11底部。如图9-11所示，压壳板中包括两个支力骨128，在底壳中对应设置有两个凹槽，支力骨128设置于凹槽中，由此压壳板与底壳相对固定。压壳板可围绕支力骨128旋转，使得凸起的尖端126可向杯体11移动并破坏杯体底部，由此释放杯体中的液体。为了增大摩擦力，可在支力骨受力端设置防滑条，如图9和10所示。
在使用图1-4所示的本申请的用于检测的装置时，可按照以下步骤进行：
（1）在杯体11中预先放置冻干检测试剂或液态检测试剂；
（2）检测样品时，将液态样品加入杯体11中，混匀，同时由配套的检测仪器控制反应时间，并提供反应所需温度；
（3）样品反应结束后，由配套的检测仪器通过杯体11上设置的突起111，旋转180°，使壳体12中凸起的尖端126将杯体11底部顶破，让反应后的液体释放到环形结构123中，并向试纸条进行渗透，实现其与试纸条的反应，该过程中配套的检测仪器仍然提供反应所需温度；
（4）当反应后的液体与试纸条的反应结束后，配套的检测仪器立即读取反应结果。
在利用图5-7所示的用于检测的装置时，步骤（3）中利用配套的检测仪器向杯体11施加压力，使壳体12中凸起的尖端126将杯体11底部顶破，其余操作步骤与上面相同。
在利用图8-11所示的装置时，步骤（3）中利用外力作用于压壳板上，使压壳板另一端的凸起的尖端126向上移动，顶破杯体11底部，其余操作与上面相同。
通过上述操作，可以获得定量、半定量或定性的结果。
本申请的装置的壳体上可设置条码、二维码等，通过配套的检测仪器读取有关信息，其中条码、二维码等的信息可包括测试项目、该批号测试卡产品的检测结果修正值参数、基于防伪或用于配套的检测仪器和测试卡之间绑定的信息等，但不仅限于上述信息。
本申请中还将本申请的装置与传统的检测装置同时进行检测牛奶（原奶）中氯霉素残留，并从检测周期、灵敏度、精密度及准确性等方面进行了对比。本次检测共分成三组：
A组：本申请的检测装置
B组：裸条+反应杯组
C组：传统卡扣组
检测结果如下：
1. 下表显示了检测周期的结果比较。
表1检测周期比对
组别 反应条件 检测周期
A组 40℃ 3min+3min
B组 40℃ 3min+5min
C组 室温 10min
2. 检测灵敏度及精密度的对比结果
用已知的阴性奶样进行添加实验,添加梯度为0.00ppb，0.05ppb，0.10ppb， 0.15ppb，0.2ppb共5个梯度，每个梯度重复20次实验，分别用肉眼观察和仪器判读两种方式对结果进行判读。
结果显示（数据略），添加0.1ppb时，A、B、C三组的检测均可100%检出。
3. 准确性实验
取50份用液质确认过的样品，分别用三种不同形式的产品进行检测，考察三种检测方法与液质方法检测结果的符合率。
检测结果显示，A组的结果与LC-MS的结果100%符合，B组的符合率为100%，C组的符合率为98%。
通过以上检测结果可以看出，本申请的检测装置在灵敏度、精密度及准确性等方面与传统方法一致，同时在检测周期上比现有的方法有明显缩短。
以上所述仅为本申请的较佳实施例而已，并不用以限制本申请，凡在本申请的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本申请的保护范围之内。

Claims (9)

  1. 一种用于免疫层析检测的装置，包括壳体和位于壳体内部的杯体，其特征在于，
    所述壳体包括向上延伸的中空突起，所述中空突起用于容纳杯体，所述杯体包括杯体壁和杯体底部，所述壳体中在所述杯体底部下方设置有凸起的尖端，所述杯体与所述凸起的尖端能相向移动，在移动过程中所述凸起的尖端能破坏所述杯体底部同时释放杯体中容纳的液体，
    所述壳体中还设置有围绕所述凸起的尖端的围栏，所述围栏包括与所述杯体底部外圆周对应的环形结构以及与所述环形结构连通的槽。
  2. 如权利要求1所述的用于免疫层析检测的装置，其特征在于，在所述围栏中所述环形结构与所述槽的连通处设置有凸起，用于与所述槽共同固定试纸条。
  3. 如权利要求1所述的用于免疫层析检测的装置，其特征在于，所述壳体底部在围栏的环形结构中的部分为坡面结构，其中所述环形结构与槽的连通处为坡面结构的坡底部分。
  4. 如权利要求1-3中任一项所述的用于免疫层析检测的装置，其特征在于，所述中空突起与所述杯体通过螺纹连接。
  5. 如权利要求4所述的用于免疫层析检测的装置，其特征在于，所述杯体壁顶部有两个以上向外延伸的突出部，利用所述突出部能向所述杯体施加扭转力。
  6. 如权利要求1-3中任一项所述的用于免疫层析检测的装置，其特征在于，所述中空突起与所述杯体通过导轨与滑槽进行连接，所述中空突起中设置有两个以上的滑槽，所述杯体外侧设置有与所述滑槽对应的导轨。
  7. 如权利要求1-3中任一项所述的用于免疫层析检测的装置，其特征在于，所述杯体通过位于所述底部外侧的两个以上的挂扣与所述中空突起连接。
  8. 如权利要求7所述的用于免疫层析检测的装置，其特征在于，所述壳体包括面壳、底壳和压板壳，其中所述中空突起位于面壳上，所述围栏位于底壳上，所述凸起的尖端位于所述压板壳上，且在所述围栏的环形结构中设置有与所述凸起的尖端对应的孔。
  9. 如权利要求8所述的用于免疫层析检测的装置，其特征在于，所述底壳与所述压壳板通过支力骨连接，所述压壳板能围绕所述支力骨枢转运动，由此使得所述凸起的尖端破坏所述杯体底部。
PCT/CN2014/089429 2014-10-24 2014-10-24 用于免疫层析检测的装置 WO2016061810A1 (zh)

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ES14904306T ES2808609T3 (es) 2014-10-24 2014-10-24 Dispositivo para ensayo inmunocromatográfico
EP14904306.9A EP3211419B1 (en) 2014-10-24 2014-10-24 Device for immunochromatographic assay
CN201490000201.5U CN206348339U (zh) 2014-10-24 2014-10-24 用于免疫层析检测的装置
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US10436782B2 (en) 2019-10-08
US20170153232A1 (en) 2017-06-01

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