WO2023035617A1 - 一种采样与检测一体化的快速检测结构及其应用 - Google Patents

一种采样与检测一体化的快速检测结构及其应用 Download PDF

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WO2023035617A1
WO2023035617A1 PCT/CN2022/087797 CN2022087797W WO2023035617A1 WO 2023035617 A1 WO2023035617 A1 WO 2023035617A1 CN 2022087797 W CN2022087797 W CN 2022087797W WO 2023035617 A1 WO2023035617 A1 WO 2023035617A1
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detection
sampling
layer
sample collection
reagent strip
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PCT/CN2022/087797
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English (en)
French (fr)
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刘默文
刘杰
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嘉兴康源科泰科技发展有限公司
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Priority to JP2022539421A priority Critical patent/JP2023544922A/ja
Publication of WO2023035617A1 publication Critical patent/WO2023035617A1/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
    • G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B10/0051—Devices for taking samples of body liquids for taking saliva or sputum samples
    • 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
    • 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
    • G01N33/577—Immunoassay; Biospecific binding assay; Materials therefor involving monoclonal antibodies binding reaction mechanisms characterised by the use of monoclonal antibodies; monoclonal antibodies per se are classified with their corresponding antigens
    • 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
    • G01N33/58—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances
    • G01N33/582—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances with fluorescent label
    • 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
    • G01N33/58—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances
    • G01N33/585—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances with a particulate label, e.g. coloured latex
    • 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 invention relates to the technical field of medical devices, in particular to a rapid detection structure integrating sampling and detection and its application.
  • Immunological detection technology is an experimental method designed to determine antigens, antibodies, immune cells and chemical components based on the principle of applied immunology. , pharmaceutical analysis, food and industrial analysis samples. Commonly used detection techniques include immunoturbidity technology, solid-phase enzyme immunoassay technology, chemiluminescence detection technology, immunofluorescent labeling technology, quantum dot immunoassay technology, colloidal gold immunoassay technology, dot immunoassay technology, etc. High sensitivity, rapidity, convenience, miniaturization, full quantification, and automation are the current development trends of clinical immunoassay technology. Point-of-care testing (POCT) is currently the fastest-growing branch, and chromatographic immunoassay is the most commonly used detection method.
  • POCT Point-of-care testing
  • the purpose of the present invention is to provide a rapid detection structure integrating sampling and detection and its application. Compared with the prior art, it has the characteristics of convenience, speed, pollution prevention, etc., and improves the detection quality.
  • the present invention provides a rapid detection structure integrating sampling and detection, including a detection card, a detection reagent strip located in the detection card, a sampling connection structure located at the starting end of the detection reagent strip, and a sampling connection structure that can be formed
  • a sampling structure with a detachable structure the sampling connection structure is a double-layer structure that communicates with each other, including a reagent detection layer and a sample collection layer, a part of the detection reagent strip is placed in the reagent detection layer, and the sample
  • the collection layer is provided with an insertion inlet of a sampling structure, a sample collection channel, and a liquid phase flow channel communicating with the reagent detection layer;
  • the sampling structure is a plug-in structure provided with a sampling head and a handle, and the handle structure is provided with a fixed
  • the sampling head is a fixed structure of the non-sampling end.
  • sampling head is a detection sampling swab-like structure provided with a water-absorbing material structure.
  • the water-absorbent material includes flocking, sponge, polyester fiber, polyester, cotton, various artificial fibers and the like.
  • the sampling connection structure is a double-layer structure with the reagent detection layer on the bottom and the sample collection layer on the top.
  • the sampling head When in use, the sampling head is inserted into the sample collection channel of the sample collection layer for use, wherein the cross-sectional area of the sample collection channel is less than For the cross-sectional area of the sampling head, the sample collection channel squeezes the sampling head during the insertion process.
  • liquid phase flow channel is opened towards the insertion inlet of the sampling structure, thereby forming an opening structure for the sample collection channel to communicate with the detection reagent strip in the reagent detection layer.
  • the rapid detection structure includes a detection aid liquid phase, which is composed of a detection aid solution and a container, and the detection aid solution is a buffered saline solution containing casein.
  • the detection reagent strip has a structure of a sample pad, a marker binding pad, a nitrocellulose membrane pad, and a water-absorbing pad that are sequentially pasted on a PVC film, and placed in the detection card.
  • the integrated structure of the rapid detection structure is the base of the detection card, the detection reagent strip bracket placed on the detection card base, and the end of the sample pad facing the insertion inlet of the sampling structure.
  • the detection reagent strip, the sample collection channel connected to the insertion inlet of the sampling structure and the double-layer structure of the sampling connection structure connected to the reagent detection layer, the upper cover of the detection card, and the sample collection channel at the insertion inlet end can form a detachable assembly
  • the detection reagent strip is selected from at least one of colloidal gold immunoassay, fluorescent immunoassay, quantum dot immunoassay, dot immunoassay, and chemiluminescence immunoassay.
  • samples collected by the sampling structure include one or more of saliva, sputum, nasal cavity fluid, urine, blood, and excretion.
  • the operation and use of the rapid detection structure includes the following steps:
  • the liquid phase contained in the sampling head flows into the sample pad of the detection reagent strip through the liquid phase flow channel, and then flows through the binding pad, nitrocellulose membrane pad, and water-absorbing pad to complete the detection;
  • the rapid detection structure of the present invention can be used for sampling and detection of samples from various sources.
  • liquid samples such as saliva, blood, urine, etc.
  • non-liquid samples such as nasal cavity, oropharynx, skin, secretions, etc.
  • the integrated rapid detection structure includes a detection card, a detection reagent strip installed in the detection card, a sampling connection structure located at the end of the detection reagent strip, and a sampling structure that can form a detachable structure with the sampling connection structure ;
  • the sampling connection structure is a double-layer structure that communicates with each other, including a reagent detection layer and a sample collection layer, and the detection reagent strip is located in the reagent detection layer,
  • the sample collection layer is provided with an insertion inlet of a sampling structure, a sample collection channel, and a liquid phase flow channel communicating with the reagent detection layer;
  • the sampling structure includes a sampling head and a sampling handle, and a sampling head fixing structure is fixedly arranged between the sampling handle and the sampling head.
  • the present invention adopts a rapid detection structure integrating sampling and detection.
  • the sampling head is in direct contact with the detection reagent strip, which not only improves the convenience of clinical samples from sampling to detection, but also can effectively avoid the interference of other factors on sample detection. Improve detection quality.
  • the background noise interference of the solid-phase membrane is reduced, the detection sensitivity is improved, and the high-sensitivity detection of the existing detection reagents is improved.
  • the sampling connection structure adopted in the present invention is a double-layer structure with the reagent detection layer on the bottom and the sample collection layer on the top.
  • the liquid phase flow channel between the double layers is located on the side of the sampling head insertion port, and the longitudinal sectional area of the sample collection channel is Smaller than the longitudinal sectional area of the sampling head, the sample collection channel squeezes the sampling head during the insertion process of the sampling head, so that the detection liquid phase can quickly flow to the sample pad of the detection reagent strip, and the sampling head is pushed forward quickly
  • the pressure accelerates the release of the label on the binding pad, speeding up the detection speed and improving the detection sensitivity.
  • the present invention adopts the detection test strip as the detection component, which is applicable to various detection technologies with lateral flow as the main technical feature, such as colloidal gold, fluorescent immunity, quantum dots, etc., expanding the scope of application.
  • the present invention is equipped with an auxiliary detection liquid phase, which can not only be used for samples with sufficient liquid phase, such as saliva, blood, etc., but also can first wet the sampling head with the detection auxiliary liquid phase, and then sample, such as feces, sputum, etc. Improve the practicality of detection.
  • the invention has simple operation steps and is easy to realize home use or self-operation. It is not only convenient to use and reduces the waste of raw materials, but also significantly improves work efficiency, and can be applied to many fields of professional and amateur testing.
  • Fig. 1 is the overall structure schematic diagram of the present invention
  • Fig. 2 is the structural schematic diagram of the longitudinal section of the rapid detection structure of the present invention.
  • Fig. 3 is a schematic diagram of a sampling structure of the present invention.
  • Fig. 4 is a schematic diagram of the sampling connection structure of the present invention.
  • Fig. 5 is a schematic diagram of a longitudinal section of a detachable structure of the present invention.
  • Fig. 6 is a schematic diagram of a detachable structure of the present invention.
  • Fig. 7 is a schematic diagram of the structure of the detection aid liquid phase of the present invention.
  • Base 1 upper cover 2; sampling structure 3; observation window 4; detection reagent strip 5; sampling handle 6; sampling head 7; sample collection channel 8; sampling connection structure 9;
  • a fixed structure 11 ; a sampling structure insertion port 12 ; a sampling structure insertion channel 13 ; a sampling structure junction 14 ; a testing aid solution 15 ; a testing aid liquid container 16 .
  • the rapid detection structure of the present invention includes a base 1, an upper cover 2, a sampling structure 3, an observation window 4, a detection reagent strip 5; a sampling handle 6; a sampling head 7; a sample collection channel 8;
  • the connection structure 9 ; the liquid phase flow channel 10 with a double-layer structure, and the sampling and detection processes can all be completed on the rapid detection structure of the present invention.
  • the sampling structure 3 of the present invention includes a sampling handle 6 and a sampling head 7;
  • the sampling handle 6 is used to place the sampling head 7 at the sampling site for sampling.
  • the rapid detection structure also includes a test aid liquid phase, which includes a test aid solution 15 and a container 16, wherein the test aid solution 15 is a buffered saline solution containing casein. If the saliva sample is collected, the sampling head 7 is put into the oral cavity. If the blood sample is collected, the sampling head 7 is put into the blood. If the urine sample is collected, the sampling head 7 is put into the urine.
  • sampling head 7 To collect samples with insufficient liquid phase, such as nasal cavity sampling, first wet the sampling head 7 with the testing aid solution 15, and then perform sampling and testing, or take a sample first, and then immerse the sampling head 7 in the testing assistant solution 15 to wash it. Demix and proceed to detection.
  • testing aid solution 15 To collect samples with insufficient liquid phase, such as nasal cavity sampling, first wet the sampling head 7 with the testing aid solution 15, and then perform sampling and testing, or take a sample first, and then immerse the sampling head 7 in the testing assistant solution 15 to wash it. Demix and proceed to detection.
  • the sampling connection structure 9 of the present invention is a double-layer structure, and the sampling connection structure 9 also includes a sampling structure insertion port 12; a sampling structure insertion channel 13; wherein the sample collection channel 8 is located on the upper floor, and the detection reagent strip 5 is installed on The lower layer starts from the insertion port 12 of the sampling structure, the upper layer is from the sampling structure insertion channel 13 to the sample collection channel 8, and the lower layer passes through the liquid phase flow channel 10 of the double-layer structure to the detection reagent strip 5.
  • the detection reagent strip 5 is a detection reagent strip prepared by the colloidal gold method, and sample pads and colloidal gold are coated with colloidal gold on the PVC film.
  • Experimental research of the present invention the following experiments illustrate the detection method and its effects of the present invention, but are not limiting to the present invention.
  • the experimental methods used in the following experiments are conventional methods unless otherwise specified.
  • the materials and reagents used can be obtained from commercial sources unless otherwise specified.
  • the detection reagent strip was prepared by the double-antibody sandwich method of conventional immune colloidal gold detection technology, and the detection kit was prepared by using the rapid detection structure of the present invention to carry out the new coronavirus antigen detection experiment.
  • the anti-new coronavirus S protein monoclonal antibody in ml is made of colloidal gold particles with a particle size of 50nm, coated on the glass cellulose membrane colloidal gold binding pad;
  • the detection line T of the detection reagent strip has a paired capture antibody of 1.0mg/ml Anti-new coronavirus S protein monoclonal antibody, coated on nitrocellulose membrane pad;
  • the capture antibody of the quality control line C of the detection reagent strip is 1.0mg/ml goat anti-mouse IgG polyclonal antibody, coated on nitrocellulose membrane
  • the pad is used to capture the colloidal gold-labeled anti-new coronavirus S protein monoclonal antibody that has not been specifically captured.
  • the upper cover, base and sampling structure of the rapid detection structure of the present invention are designed by using Solidworks, and the samples are printed in 3D, and the sponge sampling head is pasted on the sampling head fixing structure, and the prepared samples are used for experimental detection.
  • the quality control line C of the detection reagent strip has color development, and the detection line T has no color development, which is negative; the quality control line C has color development, and the detection line T also has color development, which is positive.
  • concentration of antigen S protein solution is 1.0, 0.1, 0.05ng/ml, the test results are all positive, and when the concentration is 0.01ng/ml or below, the test result is negative.
  • the detection reagent strip was prepared by the double-antibody sandwich method of conventional immunofluorescence detection technology, and the detection kit was prepared by using the rapid detection structure of the present invention to carry out the new coronavirus antigen detection experiment.
  • the anti-new coronavirus S protein monoclonal antibody in ml is made of fluorescent microspheres with a particle size of 50um and coated on the colloidal gold binding pad of glass cellulose membrane;
  • the capture antibody of the detection line T of the detection reagent strip is a paired anti- New coronavirus S protein monoclonal antibody, coated on a nitrocellulose membrane pad;
  • the capture antibody of the quality control line C of the detection reagent strip is 1.0mg/ml goat anti-mouse IgG polyclonal antibody, coated on a nitrocellulose membrane pad , used to capture fluorescent microspheres that are not specifically captured and labeled with anti-new coronavirus S protein monoclonal antibody.
  • Fluorescence detector a commercially available highlighter is used.
  • the ratio of the fluorescence luminescence value of the detection line T on the detection reagent strip to the fluorescence emission value of the quality control line C is greater than 0.02, which is positive; the ratio of the fluorescence emission value of the detection line T on the detection reagent strip to the fluorescence emission value of the quality control line C is less than or Equal to 0.02, which is negative.
  • concentration of antigen S protein solution is 1.0, 0.1, 0.05, 0.01ng/ml, the test results are all positive, and when the concentration is 0.005ng/ml or below, the test result is negative.

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Abstract

一种采样与检测一体化的快速检测结构，包括检测卡、位于检测卡内的检测试剂条（5）、位于检测试剂条（5）起始端的采样连接结构（9）以及可以与采样连接结构（9）形成可拆装式结构的采样结构（3），采样连接结构（9）为相互交通的双层结构，采样结构（3）设置有采样头（7）和手柄（6）样的插入式结构。可以用于胶体金、荧光免疫、化学发光等多种快速免疫检测产品的开发，提高了免疫检测产品的检测效率、便捷性和准确性，具有重要的临床意义。

Description

一种采样与检测一体化的快速检测结构及其应用 技术领域
本发明涉及医疗器械技术领域，尤其涉及一种采样与检测一体化的快速检测结构及其应用。
背景技术
免疫学检测技术是根据应用免疫学原理设计的测定抗原、抗体、免疫细胞及化学成分等的实验手段，广泛用于检测来源于人体和动物体可进行疾病诊断和健康检测的样品以及用于环境、药物分析、食品和工业分析的样品。常用的检测技术有免疫浊度技术、固相酶免疫测定技术、化学发光检测技术、免疫荧光标记技术、量子点免疫检测技术、胶体金免疫检测技术、斑点免疫检测技术等。高灵敏度、快速、便捷、小型化、全定量、自动化是目前临床免疫检测技术的发展趋势。床旁检测(POCT)是目前发展最快的一个分支，层析免疫检测是其最常用的检测方法，胶体金和荧光侧向流层析免疫检测技术的产品使用最广，但所采用的方法一般均为两步或两步以上，如采样、加样、观察，或采样、稀释提取、加样、观察等，因此，开发更为便捷、快速、高性能并且能提高防污染保护的检测技术，将有助于临床检测产品的普及，提高诊疗防治质量，具有重要的应用价值。
发明内容
本发明的目的是提供一种采样与检测一体化的快速检测结构及其应用，与现有技术比较，具有便捷、快速、防止污染等的特点，提高检测质量。
针对上述目的，本发明提供的一种采样与检测一体化的快速检测结构,包括检测卡、位于检测卡内的检测试剂条、位于检测试剂条起始端的采样连接结构以及可以与采样连接结构形成可拆装式结构的采样结构；所述采样连接结构为相互交通的双层结构，包括试剂检测层和样本采集层，所述试剂检测层内放置有所述检测试剂条的一部分，所述样本采集层设置有采样结构的插入入口和样本采集通道以及与所述试剂检测层交通的液相流动通道；所述采样结构为设置有采样头和手柄样的插入式结构，手柄样结构设置有固定所述采样头非采样端的固定结构。
进一步的，所述采样头为设置有吸水性材料结构的检测采样拭子样结构。所述吸水性材料包括植绒、海绵、聚酯纤维、涤纶、棉花、多种人造纤维等。
进一步的，所述采样连接结构为试剂检测层在下和样本采集层在上的双层结构，使用时将所述采样头插入样本采集层的样本采集通道内使用，其中样本采集通道的截面积小于所述采样头的截面积，插入过程中样本采集通道对采样头形成挤压。
进一步的，所述液相流动通道为开口朝向所述采样结构的插入入口的，进而形成样本采集通道与所述试剂检测层中检测试剂条相互交通的开口结构。
进一步的，所述快速检测结构包含有助检液相，由助检溶液和容器组成，所述助检溶液为含有酪蛋白的缓冲盐溶液。
进一步的，所述检测试剂条为在PVC底片上依次粘贴的样品垫、标记物结合垫、硝酸纤维素膜垫和吸水垫的结构，放置于检测卡内。
进一步的，所述快速检测结构的一体化结构，从下至上依次为检测卡的底座、置于检测卡底座上的检测试剂条托槽上的以样品垫一端朝向所述采样结构的插入入口的检测试剂条、与采样结构的插入入口相连通的样本采集通道及与试剂检测层相通的采样连接结构的双层结构，检测卡的上盖，位于插入入口端的与样本采集通道可形成可拆装式连接的含有采样头的采样结构、位于采样结构前端的采样头插入样本采集通道且允许采样头上的液相经液相流动通道流入检测试剂条样品垫而进行检测反应的工作结构、位于检测卡上卡的观察窗。
进一步的，所述检测试剂条选择胶体金免疫检测法、荧光免疫检测法、量子点免疫法、斑点免疫法、化学发光免疫检测法的至少一种。
进一步的，所述采样结构采集的样本包括唾液、痰液、鼻腔液、尿液、血液、分泌液的一种或多种。
进一步的，所述快速检测结构的操作使用，包括如下步骤：
1)从快速检测结构上取下采样结构；
2)将采样头伸入取样部位内，完成取样；
3)将采样头经所述采样结构的插入入口插入至样本采集通道；
4)静置快速检测结构，采样头所含有的液相经液相流动通道流入检测试剂条的样品垫，然后流经结合垫、硝酸纤维素膜垫、吸水垫，完成检测；
5)从观察窗读取检测结果。
本发明快速检测结构可用于多种来源的样本的采样检测，对于液态样本，如唾液、血液、尿液等，可以直接采样检测，对于非液态样本，如鼻腔、口咽、皮肤、分泌物等，可以先将采样头在助检溶液内浸润然后进行采样，或者先采样，然后将采样头置于助检溶液内，提取 混合后再进行检测。
进一步的，所述一体化的快速检测结构包括检测卡、安装于检测卡内的检测试剂条、位于检测试剂条端部的采样连接结构以及可以与采样连接结构形成可拆装式结构的采样结构；
所述采样连接结构为相互交通的双层结构，包括试剂检测层和样本采集层，所述检测试剂条位于所述试剂检测层内，
所述样本采集层开设有采样结构的插入入口和样本采集通道以及与所述试剂检测层交通的液相流动通道；
所述采样结构包括采样头和采样手柄，所述采样手柄与所述采样头之间固定设置有采样头固定结构。
本发明所述快速检测结构在快速检测产品开发中的应用。
本发明由于采取以上技术方案，其具有以下优点：
1、本发明采用采样与检测一体化的快速检测结构，采样头与检测试剂条直接接触，不仅提高了临床样本从采样到检测操作的便捷性，而且可以有效避免其它因素对样本检测的干扰，提高检测质量。同时，降低了固相膜的背景噪声干扰，提高了检测灵敏度，提高了现有检测试剂的高灵敏度检测。
2、本发明所采用的采样连接结构为试剂检测层在下和样本采集层在上的双层结构，双层间的液相流动通道位于采样头插入口一侧，且样本采集通道的纵截面积小于所述采样头的纵截面积，在采样头插入过程中样本采集通道对采样头形成挤压使用，使检测液相能够快速流至检测试剂条的样品垫上，同时采样头并迅速向前推压加速结合垫上的标记物释放，加快检测速度，提高检测灵敏度。
3、本发明采用检测试条作为检测部件，适用于多种以侧向流为主要技术特征的检测技术，如胶体金、荧光免疫、量子点等，拓展了应用范围。
4、本发明配备了助检液相，不仅可用于液相充分的样本，如唾液、血液等，也可先将采样头用助检液相湿润，然后进行采样，如粪便、痰液等，提高了检测的实用性。
5、本发明操作步骤简单，易于实现家庭化使用或自我操作，不仅使用方便、减少原料的浪费，同时也显著提高工作效率，可以应用于专业和业余检测的诸多领域。
附图说明
图1为本发明的整体结构示意图；
图2为本发明的快速检测结构纵切面结构示意图；
图3为本发明的采样结构示意图；
图4为本发明的采样连接结构示意图；
图5为本发明的拆装式结构纵切面示意图；
图6为本发明的拆装式结构示意图；
图7为本发明的助检液相结构示意图。
图中标记如下：
底座1；上盖2；采样结构3；观察窗4；检测试剂条5；采样手柄6；采样头7；样本采集通道8；采样连接结构9；双层结构的液相流动通道10；采样头固定结构11；采样结构插入口12；采样结构插入通道13；采样结构接合部14；助检溶液15；助检液容器16。
具体实施方式
为更进一步阐述本发明为达成预定目的所采取的技术手段及功效，以下所述实施例结合附图对本发明进行进一步说明，但本发明并不局限于以下说明。
如图1、图2所示，本发明的快速检测结构包括底座1、上盖2、采样结构3、观察窗4、检测试剂条5；采样手柄6；采样头7；样本采集通道8；采样连接结构9；双层结构的液相流动通道10，采样与检测过程都可以在本发明的快速检测结构上完成。
如图3、图7所示，本发明采样结构3，包括采样手柄6、采样头7；采样头固定结构11，其中采样头7经采样头固定结构11固定于采样手柄6上，操作时手持采样手柄6，将采样头7置于采样部位进行采样。快速检测结构还包含助检液相，助检液相包括助检溶液15和容器16，其中助检溶液15为含有酪蛋白的缓冲盐溶液。如采集唾液样本，则将采样头7放入口腔内。如采集血液样本则将采样头7放入血液内。如采集尿液样本，则将采样头7放入尿液内。采集液相不充分的样本，如鼻腔取样，将采样头7先用助检溶液15湿润，然后进行采样和检测，或者是，先采样，然后将采样头7浸入助检溶液15内，进行洗脱混合，然后进行检测。
如图4所示，本发明的采样连接结构9为双层结构，采样连接结构9还包括采样结构插入口12；采样结构插入通道13；其中样本采集通道8位于上层，检测试剂条5安装于下层，从采样结构的插入口12开始，上层由采样结构插入通道13至样本采集通道8，下层经双层结构的液相流动通道10至检测试剂条5。
这样在实际操作时，当本发明快速检测结构为胶体金免疫检测结构时，检测试剂条5为用胶体金法制备的检测试剂条，在PVC底片上依次粘贴有样品垫、包被有胶体金标记物的胶体金结合垫、包被有非标记捕获试剂的硝酸纤维素膜垫和吸水垫；当本发明快速检测结构为荧光免疫检测结构时，检测试剂条5为用荧光免疫法制备的检测试剂条，在PVC底片上依次粘贴有样品垫、包被有荧光标记物的荧光微球结合垫、包被有非标记捕获试剂的硝酸纤维素膜垫和吸水垫。使用时，取出检测试剂卡，从试剂卡上取下采样结构3，手持采样手柄6，用采样头7取样，然后将采样头7通过采样插入口12，经采样插入通道13插入至样本采集通道8内，此时采样头7被挤压，采集的液相样本，经双层结构的液相流动通道10流至检测试剂条5的样品垫，开始检测反应，然后读取结果。
本发明的实验研究：下述实验说明本发明的检测方法及其效果，但不是对本发明的限定。下述实验中所使用的实验方法如无特殊说明，均为常规方法。所用的材料、试剂等，如无特殊说明，均可从商业途径得到。
实验一：免疫胶体金法新冠病毒抗原快速检测实验：
一、检测试剂条制备：
采用常规免疫胶体金检测技术双抗体夹心法制备检测试剂条，采用本发明快速检测结构制备检测试剂盒进行新冠病毒抗原检测实验，其中检测试剂条的检测线T的胶体金标记指示抗体为10ug/ml的抗新冠病毒S蛋白单克隆抗体，采用粒径50nm的胶体金颗粒，包被在玻璃纤维素膜胶体金结合垫上；检测试剂条的检测线T的捕获抗体为1.0mg/ml的配对的抗新冠病毒S蛋白单克隆抗体，包被在硝酸纤维素膜垫上；检测试剂条的质控线C的捕获抗体为1.0mg/ml的羊抗鼠IgG多克隆抗体，包被在硝酸纤维素膜垫上，用于捕获未被特异性捕获的胶体金标记抗新冠病毒S蛋白单克隆抗体。在硝酸纤维素膜垫印膜两端分别粘贴吸水垫及胶体金标记结合垫，在胶体金标记结合垫一侧粘贴样品垫。置粘贴好的检测片于切条机上，切成3.5mm检测试剂条。
二、本发明快速检测结构制备：
采用Solidworks设计本发明快速检测结构的上盖、底座和采样结构，并用3D打印样品，在采样头固定结构上粘贴海绵采样头，制备的样品用于实验检测。
三、实验方法及结果：
实验时取上述制备的检测试剂条和快速检测结构，装配成检测扣卡，将装配好的检测扣卡放入有干燥剂的铝箔密封袋内，在封口机上封口，加贴标签。用健康人唾液配置不同浓度 的重组新冠病毒抗原S蛋白溶液。从检测扣卡上取下采样结构，将采样头用配置的溶液浸润，然后经插入口插入检测扣卡内，静置20分钟，查看观察窗，读取检测试剂条上的显色结果。检测试剂条质控线C有显色，检测线T无显色，为阴性；质控线C有显色，检测线T也有显色，为阳性。抗原S蛋白溶液浓度为1.0、0.1、0.05ng/ml时，检测结果均为阳性，浓度为0.01ng/ml及以下时，检测结果则为阴性。
实验二：免疫荧光法新冠病毒抗原快速检测实验：
一、检测试剂条制备：
采用常规免疫荧光检测技术双抗体夹心法制备检测试剂条，采用本发明快速检测结构制备检测试剂盒进行新冠病毒抗原检测实验，其中检测试剂条的检测线T的荧光微球标记指示抗体为20ug/ml的抗新冠病毒S蛋白单克隆抗体，采用粒径50um荧光微球，包被在玻璃纤维素膜胶体金结合垫上；检测试剂条的检测线T的捕获抗体为1.0mg/ml的配对的抗新冠病毒S蛋白单克隆抗体，包被在硝酸纤维素膜垫上；检测试剂条的质控线C的捕获抗体为1.0mg/ml的羊抗鼠IgG多克隆抗体，包被在硝酸纤维素膜垫上，用于捕获未被特异性捕获的荧光微球标记抗新冠病毒S蛋白单克隆抗体。在硝酸纤维素膜垫印膜两端分别粘贴吸水垫及荧光微球标记结合垫，在荧光微球标记结合垫一侧粘贴样品垫。置粘贴好的检测片于切条机上，切成3.5mm检测试剂条。
二、本发明快速检测结构制备：
同“实验一”制备。
三、荧光检测器：采用市售的荧光笔。
四、实验方法及结果：
实验时取上述制备的检测试剂条和快速检测结构，装配成检测扣卡，将装配好的检测扣卡放入有干燥剂的铝箔密封袋内，在封口机上封口，加贴标签。用健康人唾液配置不同浓度的重组新冠病毒抗原S蛋白溶液。从检测扣卡上取下采样结构，将采样头用配置的溶液浸润，然后经插入口插入检测扣卡内，静置20分钟，将检测扣卡置于荧光笔处，开启检测，读取检测试剂条上的荧光测试结果。检测试剂条上的检测线T荧光发光值与质控线C荧光发光值的比值大于0.02，为阳性；检测试剂条上的检测线T荧光发光值与质控线C荧光发光值的比值小于或等于0.02，为阴性。抗原S蛋白溶液浓度为1.0、0.1、0.05、0.01ng/ml时，检测结果均为阳性，浓度为0.005ng/ml及以下时，检测结果则为阴性。

Claims (11)

  1. 一种采样与检测一体化的快速检测结构,其特征在于,所述一体化的快速检测结构包括检测卡、位于检测卡内的检测试剂条、位于检测试剂条起始端的采样连接结构以及可以与采样连接结构形成可拆装式结构的采样结构；
    所述采样连接结构为相互交通的双层结构，包括试剂检测层和样本采集层，所述试剂检测层内放置有所述检测试剂条的一部分，所述样本采集层设置有采样结构的插入入口和样本采集通道以及与所述试剂检测层交通的液相流动通道；
    所述采样结构为设置有采样头和手柄样的插入式结构，手柄样结构设置有固定所述采样头非采样端的固定结构。
  2. 如权利要求1所述快速检测结构，其特征在于，所述采样头朝向所述检测卡的端部设置有吸水性材料。
  3. 如权利要求1所述快速检测结构，其特征在于，所述采样连接结构为包括试剂检测层和样本采集层的双层结构，使用时将所述采样头插入样本采集层的样本采集通道内，其中样本采集通道的截面积小于所述采样头的截面积，插入过程中样本采集通道对采样头形成挤压。
  4. 如权利要求1所述快速检测结构，其特征在于，所述液相流动通道为开口朝向所述采样结构的插入入口的，进而形成样本采集通道与所述试剂检测层中检测试剂条相互交通的开口结构。
  5. 如权利要求1所述快速检测结构，其特征在于，所述快速检测结构包含有助检液相，所述助检液相由助检溶液和容器组成，所述助检溶液为含有酪蛋白的缓冲盐溶液。
  6. 如权利要求1所述快速检测结构，其特征在于，所述快速检测结构的一体化结构，从下至上依次为检测卡的底座、置于检测卡底座上的检测试剂条托槽上的以样品垫一端朝向所述采样结构的插入入口的检测试剂条、与采样结构的插入入口相连通的样本采集通道及与试剂检测层相通的采样连接结构的双层结构，检测卡的上盖，位于插入入口端的与样本采集通道可形成可拆装式连接的含有采样头的采样结构、位于 采样结构前端的采样头插入样本采集通道且允许采样头上的液相经液相流动通道流入检测试剂条样品垫而进行检测反应的工作结构、位于检测卡上卡的观察窗。
  7. 如权利要求1所述快速检测结构，其特征在于，所述检测试剂条选择胶体金免疫检测法、荧光免疫检测法、量子点免疫法、斑点免疫法、化学发光免疫检测法的至少一种。
  8. 如权利要求1所述快速检测结构，其特征在于，所述采样结构采集的样本包括唾液、痰液、鼻腔液、尿液、血液、分泌液的一种或多种。
  9. 如权利要求6所述快速检测结构，其特征在于，所述快速检测结构的操作使用，包括如下步骤：
    1)从快速检测结构上取下采样结构；
    2)将采样头伸入取样部位内，完成取样；
    3)将采样头经所述采样结构的插入入口插入至样本采集通道；
    4)静置快速检测结构，采样头所含有的液相经液相流动通道流入检测试剂条的样品垫，然后流经结合垫、硝酸纤维素膜垫、吸水垫，完成检测。
    5)从观察窗读取检测结果。
  10. 如权利要求1所述快速检测结构在快速检测产品开发中的应用。
  11. 如权利要求1所述快速检测结构，其特征在于，所述一体化的快速检测结构包括检测卡、安装于检测卡内的检测试剂条、位于检测试剂条端部的采样连接结构以及可以与采样连接结构形成可拆装式结构的采样结构；
    所述采样连接结构为相互交通的双层结构，包括试剂检测层和样本采集层，所述检测试剂条位于所述试剂检测层内，
    所述样本采集层开设有采样结构的插入入口和样本采集通道以及与所述试剂检测层交通的液相流动通道；
    所述采样结构包括采样头和采样手柄，所述采样手柄与所述采样头之间固定设置有采样头固定结构。
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CN114441755A (zh) * 2022-02-07 2022-05-06 嘉兴康源科泰科技发展有限公司 一种双样本采样并一体化检测的组合检测结构及其应用
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