WO2023179215A1 - 一种免疫检测装置 - Google Patents

一种免疫检测装置 Download PDF

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Publication number
WO2023179215A1
WO2023179215A1 PCT/CN2023/074723 CN2023074723W WO2023179215A1 WO 2023179215 A1 WO2023179215 A1 WO 2023179215A1 CN 2023074723 W CN2023074723 W CN 2023074723W WO 2023179215 A1 WO2023179215 A1 WO 2023179215A1
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WO
WIPO (PCT)
Prior art keywords
pad
bottom plate
upper cover
test strip
detection device
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PCT/CN2023/074723
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English (en)
French (fr)
Inventor
商涛
费凤琴
蔡政君
孔健希
郑珍珍
童芳丽
Original Assignee
艾康生物技术(杭州)有限公司
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Publication of WO2023179215A1 publication Critical patent/WO2023179215A1/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
    • G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
    • 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
    • G01N33/5302—Apparatus specially adapted for immunological test procedures
    • G01N33/5304—Reaction vessels, e.g. agglutination plates
    • 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
    • G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G01N33/56983—Viruses
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/005—Assays involving biological materials from specific organisms or of a specific nature from viruses
    • G01N2333/08—RNA viruses
    • G01N2333/165—Coronaviridae, e.g. avian infectious bronchitis virus
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2469/00—Immunoassays for the detection of microorganisms
    • G01N2469/10—Detection of antigens from microorganism in sample from host

Definitions

  • the present invention relates to a detection device, in particular to an immune detection device.
  • Lateral Flow Test Strip is a commonly used rapid testing product. It uses the principle of immunochromatography to transfer samples on the test paper and obtain test results.
  • Lateral lateral flow detection test paper generally includes a base card. On the base card, there are sample pads, marker binding pads (also referred to as marker pads, usually using glass fiber as a carrier), and test pads (which are superimposed on each other from upstream to downstream). NC membrane is usually used as the carrier) and absorbent pad (absorbent materials such as filter paper are usually used).
  • the label pad includes labels that can bind to the analyte, such as latex, colloidal gold, fluorescent microspheres, etc. labeled with antigens or antibodies.
  • the test pad is generally equipped with detection lines and quality control lines.
  • the label will be captured and aggregated on the detection line or not captured. Based on the signal of the marker, such as a color signal or a fluorescence signal, the presence or concentration of the analyte is determined.
  • the quality control line can be used to determine whether the test paper is effective or to position the instrument when reading the test results.
  • test strips are generally assembled in a detection plate.
  • the detection plate includes an upper cover and a lower plate.
  • the upper plate has a sampling hole and an observation window.
  • the test strip is placed between the upper cover and the lower plate.
  • Flooding phenomenon Affect the normal operation of the test strips.
  • the torrent phenomenon is manifested as: the sample directly reaches the test strip and directly overflows the detection area of the test strip; or the liquid sample quickly runs along the edge of the bottom plate or other borders under the capillary action to the filter paper of the test strip.
  • the present invention is proposed under this background.
  • the present invention provides an immune detection device, which includes an upper cover, a bottom plate and a test strip.
  • the upper cover is snap-fitted with the bottom plate, and the test strip is placed on the bottom plate and is located between the upper cover and the bottom plate.
  • the test strip includes a longitudinal strip-shaped hard bottom card and a sample addition pad, an immune reagent identification pad, a test result display pad and an absorbent pad located on the hard bottom card and connected in pairs along its longitudinal direction.
  • the above-mentioned sample addition pad, immune reagent identification pad, test result display pad and absorbent pad are all absorbent materials.
  • the upper cover includes a sample addition hole corresponding to the sample addition pad of the test strip, and the bottom plate is on both sides of the sample addition pad of the test strip.
  • a liquid storage tank is provided, and the bottom of the liquid storage tank is lower than the bottom surface of the test strip.
  • the bottom plate is provided with a dam forming a liquid reservoir, and the bottom of the dam is lower than the bottom surface of the test strip.
  • the bottom plate is provided with a raising component, and the test strip is located on the raising component.
  • the elevated component is provided with a slope, and the end of the test strip with a sample pad is fixed on the slope by a protrusion on the bottom plate, and the end of the test strip containing the sample pad is lower than the end of the test strip.
  • Immunoassay reagent identification pad is provided with a slope, and the end of the test strip with a sample pad is fixed on the slope by a protrusion on the bottom plate, and the end of the test strip containing the sample pad is lower than the end of the test strip.
  • the two ends of the dam are respectively connected to the raising parts and the side plates of the bottom plate, thereby jointly forming the liquid storage pool.
  • the bottom plate and the upper cover are provided with anti-misinsertion structures at corresponding positions. Only when the sampling hole of the upper cover is located directly above the sampling pad of the test strip, can the upper cover be in contact with the bottom plate. combine.
  • the misinsertion prevention structure includes protrusions and matching depressions respectively provided at corresponding positions on the same side of the upper cover and the bottom plate, and protrusions and matching protrusions respectively provided at corresponding positions on opposite sides of the upper cover and the bottom plate.
  • the misinsertion prevention structure is an asymmetric structure on both sides of the immune detection device relative to the longitudinal centerline of the immune detection device.
  • the beneficial effect of the present invention is: when the liquid sample is applied to the sample pad on the test strip through the sample hole on the upper cover, the liquid sample spreads on the sample pad and is transferred to the immune reagent identification pad connected to the sample pad. , and then continue to pass to the test result display pad connected to the immune reagent identification pad, and finally reach the absorbent pad.
  • the amount (volume) of liquid sample added exceeds the amount required for detection, the liquid sample absorbed by these pads reaches a saturated state. At this time, these pads cannot generate enough power to push the excess liquid sample along the initial liquid flow.
  • the liquid sample continues to flow in the direction of the sample pad, and the excess liquid sample leaks downward from both sides or ends of the sample pad and falls into the liquid reservoirs on both sides of the sample pad.
  • the dam blocks the liquid sample in the liquid reservoir and does not flow into the end of the test strip where the absorbent pad is located, thereby preventing excess liquid samples from causing flooding, thereby improving the success rate and test results of the test. accuracy.
  • Figure 1 is a three-dimensional schematic diagram of the immune detection device of the present invention.
  • Figure 2 is a top view of Figure 1;
  • Figure 3 is a three-dimensional exploded schematic diagram of Figure 1;
  • Figure 4 is a top view of the upper cover of the immune detection device of the present invention.
  • Figure 5 is a bottom view of the upper cover of the immune detection device of the present invention.
  • Figure 6 is a schematic three-dimensional view of the base plate of the immune detection device of the present invention.
  • Figure 7 is a top view of the base plate of the immune detection device of the present invention.
  • Figure 8 is a three-dimensional schematic diagram of the test strip of the immune detection device of the present invention.
  • Figure 9 is a three-dimensional exploded schematic view of Figure 8.
  • Figure 10 is a schematic three-dimensional view of the immune detection device of the present invention with the upper cover removed;
  • Figure 11 is a top view of Figure 10
  • Figure 12 is a cross-sectional view along the longitudinal centerline C-C direction of Figure 11 (the test strip is not sectioned);
  • Figure 13 is a partial enlarged schematic diagram of part "A" in Figure 10;
  • Figure 14 is a partial enlarged schematic diagram of part "B" in Figure 12;
  • Figure 15 is a schematic diagram of the immunoassay device of the present invention after adding an excess liquid sample and the excess liquid sample overflowing from the sample pad of the test strip (the upper cover has been removed for the convenience of observation);
  • Figure 16 is a schematic diagram of the instructions for assembling the upper cover of the immune detection device to the lower plate in the correct orientation of the present invention
  • Figure 17 is a schematic diagram of the immune detection device according to the present invention when the upper cover is assembled to the lower plate in the wrong orientation.
  • the present invention provides an immune detection device 1, which includes an upper cover 10, a bottom plate 20 and a test strip 30.
  • the upper cover 10 and the bottom plate 20 are bonded by buckling, welding, glue, etc.
  • the test strip 30 is placed on the bottom plate 20 and between the upper cover 10 and the bottom plate 20 .
  • the test strip 30 is in a vertical shape.
  • the test strip 30 sequentially includes a sample addition pad 31, an immune reagent identification pad 32, a test result display pad 33 and an absorbent pad 34 connected in pairs along its longitudinal direction (i.e., the direction indicated by arrow “D” in Figure 8).
  • the sample addition pad 31, the immune reagent identification pad 32, the test result display pad 33 and the water-absorbent pad 34 are all made of water-absorbent materials.
  • the pads 31 to 34 are adhered to the elongated rigid base card 35 . In the preferred solution, these pads 31-34 are connected two by two in an overlapping manner (ie, as shown in Figure 8).
  • the liquid sample when an appropriate amount of liquid sample for detection is applied to the preset area of the sampling pad 31, When a certain area is reached, the liquid sample will flow through pads 31, 32, 33 and 34 sequentially in the direction indicated by arrow “D", and finally It is absorbed by the absorbent pad 34. During the flow process, the liquid sample dissolves the labeling reagents pre-marked on the identification pad 32, and then continues to flow in the direction indicated by arrow “D” with these labeling reagents.
  • the liquid When it flows through the test result display pad 33, the liquid The analytes and labeled reagents in will be captured by the preset T line (test line) and C line (quality control line) areas on the pad 33 and then display colors, based on which the test result is judged to be negative, positive or invalid.
  • T line test line
  • C line quality control line
  • the upper cover 10 includes a sampling hole 11 and an observation hole 12 respectively corresponding to the sampling pad 31 and the test result display pad 33 of the test strip 30 .
  • the liquid sample for detection is applied to the sampling pad 31 via the sampling hole 11 .
  • the color changes of the T line and C line areas on the detection result display pad 33 are observed through the observation hole 12, and the detection result is determined based on this (the determination method is as described above).
  • the observation hole 12 may not be a hole, but a transparent window, and any structure can be used as long as the color change of the T line and C line areas on the display pad 33 can be observed.
  • the bottom plate 20 is provided with a liquid reservoir 21 on both sides of the sample pad 31 of the test strip 30.
  • the bottom 22 of the liquid reservoir 21 is lower than the bottom surface of the test strip 30. 36.
  • the bottom plate 20 is provided with a dam 23 forming a liquid reservoir 21.
  • the bottom of the dam 23 is the bottom 22 of the liquid reservoir 21, so the bottom of the dam 23 is also lower than the bottom surface 36 of the test strip 30.
  • Figures 6, 7 and 10 show that there are two liquid reservoirs 21 on each side of the test strip 30. There can also be only one or more than two liquid reservoirs on each side.
  • the bottom plate 20 is provided with a raising component 24 (shown in FIG. 6 ), and the test strip 30 is located on the raising component 24 (shown in FIGS. 10 , 12 , 13 , and 14 ).
  • the raising component 24 is provided with a slope 25 .
  • the end of the test strip 30 with the sample pad 31 is fixed on the slope 25 by the protrusion 26 on the bottom plate 20 (shown in Figure 13). Therefore, the end 37 of the test strip 30 containing the end with the sample pad 31 Lower than the immunoreagent identification pad 32, that is, when viewed from the side, the end 37 of the sample adding pad 31 should be bent downward at an appropriate angle (as shown in Figure 14).
  • the advantage of this design is that after the liquid sample is applied to the sampling pad 31, it must first climb the slope and then be transferred to the pad 32, pad 33 and pad 34 in sequence, so it is beneficial to control the transmission speed of the liquid sample.
  • the two ends of the dam 23 are respectively connected to the raising member 24 and the side plate 27 of the bottom plate 20 , thereby jointly forming a liquid reservoir 21 .
  • the beneficial effect brought by the above structure is: when the liquid sample is applied to the sample pad 31 on the test strip 30 through the sample hole 11 of the upper cover 10, the liquid sample spreads on the sample pad 31 and is transferred to the sample pad 31.
  • the sample pad 31 is connected to the immune reagent identification pad 32, and then continues to pass to the test result display pad 33 connected to the immune reagent identification pad 32, and finally reaches the water-absorbent pad 34.
  • the driving force for the liquid sample to be transferred from the sampling pad 31 to the pads 32, 33 and 34 in sequence on the test strip 30 mainly comes from the pulling force of the absorbent pad 34 (because the absorbent capacity of the absorbent pad 34 is far greater than that of the pads 32 and 34).
  • Pad 33 the driving force for the liquid sample to be transferred from the sampling pad 31 to the pads 32, 33 and 34 in sequence on the test strip 30 mainly comes from the pulling force of the absorbent pad 34 (because the absorbent capacity of the absorbent pad 34 is far greater than that of the pads 32 and 34).
  • the liquid sample flows from the sampling pad 31 onto the bottom plate 20 and then bypasses the pad 32 and the pad. 33 directly reaches the absorbent pad 34.
  • the absorbent pad 34 will compete with the pads 32 and 33 and absorb a large amount of liquid sample at a much faster rate than the pads 32 and 33 , resulting in the pads 32 and 33 becoming full before they are full.
  • the pad 34 has no power to pull the liquid sample and the liquid sample is transferred along the pad 31, the pad 32, the pad 33 and the pad 34 in sequence.
  • the pad 34 because the pad 34 has absorbed the liquid sample first, the liquid sample will move from the pad 34 to the pad 34.
  • Pad 33 and pad 32 flow in opposite directions. Since the reverse flow liquid sample does not dissolve the identification reagent on the immune reagent identification pad 32, when it reaches the test result display pad 33, there is no identification reagent to combine with the detection reagent on the pad 33. Therefore, even if it is positive, The sample also fails to display colored indicator lines, thus giving false detection results. This process is what is known in the art as flooding. In the present invention, excess liquid sample 50 leaks downward from both sides or end portions 37 of the sampling pad 31 and falls into the liquid reservoirs 21 on both sides of the sampling pad 31 (as shown in FIG. 15 ). The dam 23 blocks the liquid sample in the liquid reservoir 21 and does not flow into the end of the test strip 30 where the absorbent pad 34 is located. The liquid sample does not bypass the pad 32 and the pad 33 to reach the pad 34, thus preventing unnecessary The liquid sample 50 generates a flooding phenomenon, thereby improving the success rate of the detection results and the accuracy of the detection.
  • the base plate 20 and the upper cover 10 are provided with misinsertion prevention structures at corresponding positions.
  • the anti-misinsertion structure includes protrusions 28 and recesses 29 respectively provided at corresponding positions on the same side (T) of the upper cover 10 and the bottom plate 20 and corresponding positions respectively provided on the opposite sides (Y) of the upper cover 10 and the bottom plate 20 .
  • the bump 28 is paired with the bump 28 . Only When the sampling hole 11 of the upper cover 10 is located directly above the sampling pad 31 of the test strip 30, the protrusion 28 of the upper cover 10 corresponds to the depression 29 of the bottom plate, and the depression 29 of the upper cover 10 corresponds to the protrusion of the bottom plate. 28.
  • the upper cover 10 can snap together with the bottom plate 20 (as shown in Figure 16).
  • the protrusion 28 of the upper cover 10 corresponds to the protrusion 28 of the bottom plate.
  • the two protrusions 28 will abut each other, causing the upper cover 10 to fail to snap together with the bottom plate 20 (as shown in Figure 17), thus giving a signal of misinsertion, prompting the operator to turn the upper cover 10 180 degrees before trying again. Snap onto the base plate 20 .
  • the misinsertion prevention structure is an asymmetric structure on both sides of the immune detection device 1 relative to the longitudinal centerline of the immune detection device (line CC in Figure 11).
  • the beneficial effect of the misinsertion prevention structure of the present invention is that the operator does not need to carefully distinguish the shapes of the upper cover 10 and the bottom plate 20 (in fact, the shape difference between the bottom plate 20 when it is in the normal position and the abnormal position after being turned 180 degrees is not obvious) , difficult to distinguish quickly), there is no need to observe the placement of the upper cover 10 and the bottom plate 20, but only need to align the upper cover and the bottom plate along their longitudinal direction and then press the upper cover toward the bottom plate. If it can be smoothly buckled , it means that the top cover and bottom plate are fastened correctly, and the product is a qualified product. On the contrary, if the upper cover cannot be smoothly fastened to the bottom plate, it means that the fastening method of the upper cover and the bottom plate is wrong.
  • the misinsertion prevention structure of the present invention reduces the operator's burden (the operator does not need to carefully observe whether the upper cover is placed in the correct orientation), improves the operator's work efficiency, and improves the product qualification rate.
  • the sampling hole of the upper cover is not facing the test
  • the sample pad on the strip is the absorbent pad on the test strip. Obviously, the product is unqualified.
  • the present invention improves the product qualification rate.
  • the unfavorable consequences of this unqualified product are: because the product failed to give an unqualified signal, the operator did not know it and mistakenly thought it was a qualified product (difficult to detect with the naked eye), and delivered it to the inspection personnel for use.
  • the tester applies the liquid sample to the sampling hole of the upper cover for testing, the product cannot give correct test results, causing the test to fail.
  • the sample needs to be extracted again and a qualified product needs to be used for retesting. Therefore, it resulted in a huge waste of manpower and material resources, resulting in adverse consequences.
  • the invention can be used for antigen detection of epidemic infectious diseases such as novel coronavirus (SARS-CoV-2). Measurement.
  • the immune detection device of the present invention adopts lateral lateral flow technology, and includes an anti-new coronavirus (anti-SARS-CoV-2) antibody-latex marker on its immune reagent identification pad 32, and a detection line on its detection result display pad 33 (T line) is coated with anti-SARS-CoV-2 antibodies, and its test results show that the quality control line (C line) on pad 33 is coated with goat anti-mouse IgG.
  • the prepared test paper can also be assembled and used in a test plate.
  • SARS-CoV-2 novel coronavirus
  • SARS-CoV-2 coronavirus-2 antigen detection test strips
  • the advantage is that it is fast, simple and easy to implement. For those whose test results are positive, they can also be asked to undergo nucleic acid testing for review.

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Abstract

一种免疫检测装置（1），包括上盖（10）、底板（20）和测试条（30），上盖（10）与底板（20）卡扣结合，测试条（30）位于上盖（10）与底板（20）之间。测试条（30）具有加样垫（31），底板（20）在测试条（30）之加样垫（31）的两侧设有储液池（21），用于吸收多余的液体样本。该免疫检测装置（1）能有效避免加入过量的液体样本时发生洪流现象，有利于提高检测的成功率，具有操作简单、使用方便、快速获得检测结果的优点。

Description

一种免疫检测装置 技术领域
本发明涉及一种检测装置，尤其是涉及一种免疫检测装置。
背景技术
侧向横流检测试纸(Lateral Flow Test Strip)是目前常用的快速检测产品，其利用免疫层析原理实现样本在试纸上的传递并获得检测结果。侧向横流检测试纸一般包括底卡，在底卡上从上游到下游依次相互叠加的粘附有样本垫、标记物结合垫(又可简称标记垫，通常采用玻纤作为载体)、测试垫(通常采用NC膜作为载体)和吸水垫(通常采用滤纸等吸水性材料)。标记垫上包括能与被分析物结合的标记物，例如标记了抗原或抗体的乳胶、胶体金、荧光微球等。测试垫上一般设有检测线和质控线。根据反应原理的不同，随着样本在试纸上的流动，标记物会在检测线上被捕获并聚集或不被捕获。根据标记物的信号，例如颜色信号或荧光信号，判断被分析物是否存在或其浓度。质控线可用于判断试纸是否有效或用于仪器读取检测结果时的定位等作用。
在一些检测装置中，试纸条一般装配在检测板中。检测板包括上盖和下板，上板上具有加样孔和观察窗，试纸条被安置在上盖和下板之间。当将液体样本滴加在检测板的加样孔后，若液体样本的量较大时，会导致大量的样品涌入到下板上的卡槽中，从而引发洪流现象(Flooding现象)，从而影响试纸条的正常工作。所述洪流现象表现为：样本直接到达试纸条而引起的直接漫过试纸条的检测区；或液体样本在毛细作用下沿着底板的边缘或其他边框快速的跑到检测试纸的滤纸处，并被滤纸吸收。这部分液体样本快于通过标记垫、NC膜上的流动的液体。提前被滤纸吸收的液体样本会反向地流向NC膜，从而影响试纸的正常工作。并且，现有的上盖和下板没有设计防误插结构图，将上盖翻转向180度依然可以插入到下板上，但是此时上盖上的加样孔并不是正对着试纸条上的加样垫的合适区域而是正对着吸水垫上的某个区域。如此一来，当向加样孔施加液体样本时， 显然液体亲本并没有被施加在试纸条的正确位置上，从而带检测结果失败的后果。造成了大量的人力物力的浪费。
本发明就是在这样的背景下提出来的。
发明内容
为了解决上述技术问题，本发明提供了一种免疫检测装置，包括上盖、底板和测试条，上盖与底板卡扣结合，测试条被安置在底板上并且位于上盖与底板之间，所述测试条包括纵长条状的硬质底卡和位于该硬质底卡上并且沿其纵长方向依次两两连接的加样垫、免疫试剂标识垫、检测结果显示垫和吸水垫，所述加样垫、免疫试剂标识垫、检测结果显示垫和吸水垫均为吸水性材料，上盖包括对应于测试条之加样垫的加样孔，底板在测试条之加样垫的两侧设有储液池，该储液池的底低于测试条的底面。
作为本发明的进一步改进：底板设有形成储液池的坝，该坝的底低于测试条的底面。
作为本发明的进一步改进：底板设有垫高部件，测试条位于该垫高部件上。
作为本发明的进一步改进：垫高部件设有斜坡，测试条在其加样垫的那一端被底板上的突起固定在该斜坡上，测试条含有加样垫的那一端的端部低于所述免疫试剂标识垫。
作为本发明的进一步改进：坝的两端分别与垫高部件和底板的侧板连接，从而共同形成所述储液池。
作为本发明的进一步改进：底板和上盖在相对应的位置处设有防误插结构，只有当上盖的加样孔位于测试条之加样垫的正上方时，上盖才能与底板相结合。
作为本发明的进一步改进：防误插结构包括分别设置在上盖和底板同侧之对应位置处的凸起配对凹陷以及分别设置在上盖和底板异侧之对应位置处的凸起配对凸起。
作为本发明的进一步改进：防误插结构在免疫检测装置的两侧相对于该免疫检测装置在其纵向中心线为非对称结构。
有益效果
本发明的有益效果是：当液体样本经由上盖的加样孔被施加到测试条上的加样垫时，液体样本在加样垫上扩散，并且传递到与加样垫连接的免疫试剂标识垫，然后再继续传递到与免疫试剂标识垫连接的检测结果显示垫，最后到达吸水垫。当加入的液体样本的量(容积)超过检测所需要的量时，这些垫吸收的液体样本达到了饱和状态，此时，这些垫无法产生足够的动力推动多余的液体样本沿着初始时液体流动的方向继续流动，多余的液体样本从加样垫的两侧或者端部向下渗漏，落入到加样垫两侧的储液池内。坝将液体样本阻挡在储液池内，而不会流入到测试条之吸水垫所在的那一端，从而防止了多余的液体样本产生洪流现象(Flooding)，进而提高了检测结果的成功率和检测结果的准确性。
附图说明
图1是本发明免疫检测装置的立体示意图；
图2是图1的俯视图；
图3是图1的立体分解示意图；
图4是本发明免疫检测装置之上盖的俯视图；
图5是本发明免疫检测装置之上盖的仰视图；
图6是本发明免疫检测装置之底板的立体示意图；
图7是本发明免疫检测装置之底板的俯视图；
图8是本发明免疫检测装置之测试条的立体示意图；
图9是图8的立体分解示意图；
图10是本发明免疫检测装置移除上盖后的立体示意图；
图11是图10的俯视图；
图12是图11沿其纵向中心线C-C方向的剖视图(测试条未剖)；
图13是图10之“A”部的局部放大示意图；
图14是图12之“B”部的局部放大示意图；
图15本发明免疫检测装置在加入过量的液体样本后，多余的液体样本从测试条之加样垫溢出后的示意图(为方便观察，已移除上盖)；
图16是是本发明免疫检测装置将其上盖以正确方位组合到下板的指示示意图；
图17是本发明免疫检测装置将其上盖以错误方位组合到下板的指示示意图。
具体实施方式
下面通过实施例，并结合附图，对本发明的技术方案作进一步具体的说明。
请参照图1－17所示，本发明提供了一种免疫检测装置1，包括上盖10、底板20和测试条30，其中上盖10与底板20以卡扣、焊接、胶水粘结等方式相结合，测试条30被安置在底板20上并且位于上盖10与底板20之间。
请参照图8、9所示，测试条30呈纵长形。测试条30沿其纵长方向(即图8中箭头“D”所指示的方向)依次包括两两连接的加样垫31、免疫试剂标识垫32、检测结果显示垫33和吸水垫34。加样垫31、免疫试剂标识垫32、检测结果显示垫33和吸水垫34均为吸水性材料。垫31至垫34被粘贴到纵长条状的硬质底卡35上。在优选方案中，这些垫31-34以首尾搭接的方式(即图8所示的方式)两两相连，因而，当将适量的用于检测的液体样本施加到加样垫31的预先设定的区域时，该液体样本将沿着箭头“D”所指示的方向，依次流过垫31、32、33和34，并且最终 被吸水垫34吸收掉。液体样本在流动的过程中，溶解预先标记在标识垫32上的标记试剂，然后带着这些标记试剂继续沿箭头“D”所指示的方向流动，当其流经检测结果显示垫33时，液体中的被分析物和标记试剂将被垫33上预先设置的T线(检测线)和C线(质控线)区域所俘获然后显示出颜色，据此判定检测结果为阴性、阳性或者无效。一般情况下，a、如果在C线区域未显示颜色则表示检测无效，需要重新检测；b、如果在C线区域显示颜色，并且在T线区域未显示颜色则表示检测结果为阴性；c、如果在C线区域和T线区域均显示颜色则表示检测结果为阳性。
请参照图1、2、3和4所示，上盖10包括分别对应于测试条30之加样垫31和检测结果显示垫33的加样孔11和观测孔12。用于检测的液体样本经由加样孔11施加到加样垫31上。检测结束后，经由观测孔12观察检测结果显示垫33上T线和C线区域的颜色变化，据此来判定检测结果(判定方法如上所述)。在另一个实施例中，观测孔12也可以不是孔，而是透明窗，只要能够观察到显示垫33上T线和C线区域的颜色变化的任何结构均可。
请参照图6、7、10-15所示，底板20在测试条30之加样垫31的两侧分别设有储液池21，该储液池21的底22低于测试条30的底面36。底板20设有形成储液池21的坝23，坝23的底就是储液池21的底22，因此坝23的底也低于测试条30的底面36。图6、7和图10中显示在测试条30的每侧各有两个储液池21，也可以是每侧只有一个或者二个以上的储液池。底板20设有垫高部件24(图6所示)，测试条30位于该垫高部件24上(图10、12、13、14所示)。
垫高部件24设有斜坡25。测试条30在其加样垫31的那一端被底板20上的突起26固定在该斜坡25上(图13所示)，因而，测试条30之含有加样垫31的那一端的端部37低于所述免疫试剂标识垫32，即，从侧面看，加样垫31的端部37要向下弯拆适当的角度(图14所示)。该设计的优点在于：液体样本施加到加样垫31后，要先爬坡，然后再依次传输到垫32、垫33和垫34，因此有利于控制液体样本的传输速度。
如图6、7所示，坝23的两端分别与垫高部件24和底板20的侧板27连接，从而共同形成了储液池21。
上述结构带来的有益效果是：当液体样本经由上盖10的加样孔11被施加到测试条30上的加样垫31时，液体样本在加样垫31上扩散，并且传递到与加样垫31连接的免疫试剂标识垫32，然后再继续传递到与免疫试剂标识垫32连接的检测结果显示垫33，最后到达吸水垫34。正常情况下，液体样本在测试条30上由加样垫31依次传输到垫32、垫33和垫34的动力主要来自吸水垫34的拉力(因为吸水垫34的吸水能力远远超过垫32和垫33)。然而，对现有的检测装置而言，当加入的液体样本的量(容积)超过检测所需要的量时，液体样本从加样垫31上流入到底板20上，然后绕过垫32和垫33直接到达吸水垫34。此时，吸水垫34将与垫32和垫33竞争并且以比垫32和垫33快的多的速度吸收掉大量的液体样本，从而导致在垫32和垫33还没有吸饱之前就吸饱液体样本了，此时垫34就没有动力去拉动液体样本依次沿垫31、垫32、垫33和垫34传输了，并且反而会因为34先吸饱了液体样本，导致液体样本由垫34向垫33和垫32反向倒流。由于反向倒流的液体样本没有溶解免疫试剂标识垫32上的标识试剂，因此，当其到达检测结果显示垫33上时，便没有标识试剂与垫33上的检测试剂结合，因此，即使是阳性样本也不能显示出有颜色的指示线条，从而给出了错误的检测结果，该过程就是本领域所说的洪流现象(Flooding)。在本发明中，多余的液体样本50从加样垫31的两侧或者端部37向下渗漏，落入到加样垫31两侧的储液池21内(如图15所示)。坝23将液体样本阻挡在储液池21内，而不会流入到测试条30之吸水垫34所在的那一端，液体样本不会绕过垫32和垫33到达垫34，从而防止了多余的液体样本50产生洪流现象(Flooding)，进而提高了检测结果的成功率和检测的准确性。
请参照图16、17所示，本发明的另一个改进之处在于：底板20和上盖10在相对应的位置处设有防误插结构。防误插结构包括分别设置在上盖10和底板20同侧(T)之对应位置处的凸起28配对凹陷29以及分别设置在上盖10和底板20异侧(Y)之对应位置处的凸起28配对凸起28。只 有当上盖10的加样孔11位于测试条30之加样垫31的正上方时，上盖10的凸起28对应于底板之凹陷29，上盖10的凹陷29对应于底板之凸起28，此时，上盖10才能与底板20卡扣结合(如图16所示)。反之，当将上盖10翻转180度，使上盖上的加样孔11位于测试条之吸水垫34的正上方时，上盖10的凸起28对应于底板之凸起28，此时，两个凸起28将相互抵靠，导致上盖10不能与底板20卡扣结合(如图17所示)，从而给出了误插的信号，提示操作者将上盖10翻转180度后再卡扣到底板20上。从图16、17显而易见，防误插结构在免疫检测装置1的两侧相对于该免疫检测装置在其纵向中心线(如图11中的线C-C)为非对称结构。
本发明设置防误插结构的有益效果是：操作者无需仔细分辨上盖10和底板20的形状(事实上，底板20处于正常位和处于翻转180度后的异常位时的形状差异并不明显，难以迅速地分辨出来)，甚至于无需观察上盖10和底板20的摆放位置，而仅需要将上盖和底板沿其纵长方向对齐后将上盖压向底板，如果能够顺利卡扣，则说明上盖与底板的卡扣方式正确，该产品是个合格品。反之，如果上盖不能顺利地卡扣到底板上，则说明上盖与底板的卡扣方式错误，此时，操作者就需要将上盖翻转180度后就能够顺利地卡扣到底板20上了，该产品依然是个合格品。因此，本发明设置防误插结构具有减轻了操作者的负担(操作者无需仔细观察上盖摆放的方位是否正确)、提高了操作者的工作效率、提高了产品的合格率。然而，那些不具有防误插结构的现有产品，其上盖以翻转180度后的异常方位插入到底板时，依然可以卡扣到底板，但是，上盖的加样孔正对的不是测试条上的加样垫，而是测试条上的吸水垫，显然该产品是不合格产品。因而，相对于现有技术，本发明提高了产品的合格率。该不合格产品造成更加不利的后果是：由于产品未能给出不合格的信号，操作者不知道，误认为其是合格产品(肉眼难以发现)，将其交付给检测人员使用。当检测人员将液体样本施加到上盖的加样孔进行检测时，该产品无法给出正确的检测结果，导致检测失败，需要重新提取样本，换用一个合格的产品重新检测。因此，造成了人力物力的巨大浪费，造成了不利的后果。
本发明可用于新型冠状病毒(SARS-CoV-2)等流行性传染病病毒抗原检 测。本发明免疫检测装置采用侧向横流技术，在其免疫试剂标识垫32上包括有抗新型冠状病毒(抗SARS-CoV-2)抗体-乳胶标记物，在其检测结果显示垫33上的检测线(T线)包被有抗SARS-CoV-2抗体，在其检测结果显示垫33上的质控线(C线)包被有羊抗鼠IgG。制备好的检测试纸还可以装配在检测板中使用。这类新型冠状病毒(SARS-CoV-2)抗原检测试纸可用于人群快速筛查和分流管理，以缩短传播链，优点是快速、简单、易行。对于检测结果为阳性的人员，还可以要求其再做核酸检测，进行复核。
以上的描述仅为本发明的具体实施方式，并非因此限制本发明所要求保护的范围。凡是利用本发明说明书及附图内容所作的等效结构或等效流程变换，或直接或间接运用在其它相关的技术领域，均应当包括在本发明的保护范围内。

Claims (8)

  1. 一种免疫检测装置，其特征在于：包括上盖、底板和测试条，所述上盖与底板卡扣结合，所述测试条被安置在底板上并且位于上盖与底板之间，所述测试条包括纵长条状的硬质底卡和位于该硬质底卡上并且沿其纵长方向依次两两连接的加样垫、免疫试剂标识垫、检测结果显示垫和吸水垫，所述加样垫、免疫试剂标识垫、检测结果显示垫和吸水垫均为吸水性材料，上盖包括对应于测试条之加样垫的加样孔，底板在测试条之加样垫的两侧设有储液池，该储液池的底低于测试条的底面。
  2. 根据权利要求1所述的免疫检测装置，其特征在于：所述底板设有形成储液池的坝，该坝的底低于测试条的底面。
  3. 根据权利要求2所述的免疫检测装置，其特征在于：所述底板设有垫高部件，测试条位于该垫高部件上。
  4. 根据权利要求3所述的免疫检测装置，其特征在于：所述垫高部件设有斜坡，所述测试条在其加样垫的那一端被底板上的突起固定在该斜坡上，测试条含有加样垫的那一端的端部低于所述免疫试剂标识垫。
  5. 根据权利要求4所述的免疫检测装置，其特征在于：所述坝的两端分别与垫高部件和底板的侧板连接，从而共同形成所述储液池。
  6. 根据权利要求1所述的免疫检测装置，其特征在于：所述底板和上盖在相对应的位置处设有防误插结构，只有当上盖的加样孔位于测试条之加样垫的正上方时，上盖才能与底板相结合。
  7. 根据权利要求6所述的免疫检测装置，其特征在于：所述防误插结构包括分别设置在上盖和底板同侧之对应位置处的凸起配对凹陷以及分别设置在上盖和底板异侧之对应位置处的凸起配对凸起。
  8. 根据权利要求7所述的免疫检测装置，其特征在于：所述防误插结构在免疫检测装置的两侧相对于该免疫检测装置在其纵向中心线为非对称结构。
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CN110361529A (zh) * 2019-07-19 2019-10-22 广东盛泽康华生物医药有限公司 一种试剂卡、检测方法及应用
CN212622625U (zh) * 2020-04-10 2021-02-26 芜湖森爱驰生物科技有限公司 一种二联抗体快检试剂盒
CN215866708U (zh) * 2021-06-24 2022-02-18 中元汇吉生物技术股份有限公司 一种免疫层析试剂卡
CN216310021U (zh) * 2022-03-15 2022-04-15 天津贝罗尼生物科技有限公司 一种基于胶体金法的新冠病毒检测试剂盒
CN114705851A (zh) * 2022-03-24 2022-07-05 艾康生物技术(杭州)有限公司 一种免疫检测装置
CN217739199U (zh) * 2022-03-24 2022-11-04 艾康生物技术(杭州)有限公司 一种生物样本的检测装置
CN217739200U (zh) * 2022-03-24 2022-11-04 艾康生物技术(杭州)有限公司 一种检测装置

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