WO2023071084A1 - Column push type sampling and detection integrated rapid detection structure and application thereof - Google Patents

Column push type sampling and detection integrated rapid detection structure and application thereof Download PDF

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Publication number
WO2023071084A1
WO2023071084A1 PCT/CN2022/087798 CN2022087798W WO2023071084A1 WO 2023071084 A1 WO2023071084 A1 WO 2023071084A1 CN 2022087798 W CN2022087798 W CN 2022087798W WO 2023071084 A1 WO2023071084 A1 WO 2023071084A1
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sampling
detection
sample
reagent strip
sleeve
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PCT/CN2022/087798
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French (fr)
Chinese (zh)
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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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Publication of WO2023071084A1 publication Critical patent/WO2023071084A1/en

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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
    • G01N33/577—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
    • 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
    • A61B10/0038—Devices for taking faeces samples; Faecal examination devices
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • 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
    • G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • 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
    • G01N33/54313—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals the carrier being characterised by its particulate form
    • 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
    • G01N33/569—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
    • G01N33/58—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
    • G01N33/587—Nanoparticles
    • 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 column-push 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 object of the present invention is to provide a rapid detection structure which has the characteristics of convenience, speed, pollution prevention, etc. and has good detection quality and can be used as on-site or home detection.
  • the present invention provides a column-push type sampling detection integrated rapid detection structure, including a detection sleeve, a detection reagent strip located in the detection sleeve, a sampling connection structure located at the starting end of the detection reagent strip, and can be connected with
  • the sampling connection structure forms a detachable sampling structure, characterized in that:
  • the rapid detection structure is a columnar structure, and the detection is completed by inserting the sampling head into the detection sleeve in a columnar push-type manner.
  • the sampling structure is located at the bottom, and forms a detachable connection with the sampling connection structure upwards.
  • the connection structure is upwardly connected with the detection sleeve;
  • the detection reagent strip is arranged in the detection sleeve, and sequentially includes a sample pad, a marker binding pad, a nitrocellulose membrane pad and an absorbent paper pad from the lower end to the upper end;
  • the sampling connection structure is a tubular structure in the same vertical direction as the detection reagent strip, the distal end is a blind end, the proximal end is provided with an opening, and the middle section is provided with a sample pool and a sample outflow opening, which are arranged on the The side of the detection reagent strip, wherein the sample pool and the sample outflow opening are adjacent to and communicated with the sample pad of the detection reagent strip;
  • the sampling structure is a plug-in structure provided with a sampling head and a sampling handle, wherein the connection between the sampling head and the sampling handle is provided with a blocking structure to prevent liquid phase reflux;
  • the sampling head is inserted into the tubular structure through the opening of the sampling connection structure, and is squeezed at the far end, and the proximal end of the tubular structure is provided with an anti-liquid phase that matches the blocking structure.
  • Backflow sleeve structure
  • the sampling head is a detection sampling swab-like structure provided with a water-absorbing material structure.
  • Water-absorbing materials are roughly divided into natural and modified polymer superabsorbent resins and artificially synthesized water-absorbing resins, including starch series, cellulose series, other natural product series, polyvinyl salt series, polyvinyl alcohol series and polyoxyethylene series etc. Some of the polyvinyl alcohol series products have the characteristics of drying and hardening, and absorbing water and softening.
  • Polyvinyl alcohol (PVA) absorbent sponge not only has excellent chemical stability, water absorption function and high-quality physical properties, but also has the characteristics of fast water absorption rate, high liquid absorption rate, and softness after absorbing water. It is widely used in daily cleaning, medical and health fields, etc. use.
  • the inner diameter of the pipe at the far end of the sample pool of the pipe-shaped structure and the sample outflow opening is smaller than the inner diameter of the pipe at the proximal end, and the sampling head is inserted into the pipe-shaped structure during use.
  • the pipe-like structure forms an extrusion on the sampling head. .
  • the structure for preventing liquid phase backflow arranged on the sampling connection structure consists of an elastic washer arranged at the connection part between the sampling head and the sampling handle and a sleeve structure arranged at the distal end of the tubular structure In use, the elastic washer slides up and down in the sleeve structure.
  • the end of the sample pad of the detection reagent strip is placed in the sample pool.
  • the rapid detection structure includes a test aid liquid phase, which is composed of a test aid solution and a container, and the test aid solution is a buffered saline solution containing casein.
  • the integrated structure of the rapid detection structure is that the sampling structure that can form a detachable connection with the sampling connection structure includes a sampling handle and a blocking structure arranged on the sampling handle and the sampling head, the pipe-shaped structure inlet, the proximal end, the sleeve structure, the sample pool, the sample outflow opening and the far end of the sampling connection structure inserted into the sampling head, the brackets arranged on the side of the sampling connection structure and the placement The detection reagent strip on the bracket is connected to the sample outflow opening of the sample pool with the sample pad, and the buckle sleeve is detected.
  • the sampling structure that can form a detachable connection with the sampling connection structure includes a sampling handle and a blocking structure arranged on the sampling handle and the sampling head, the pipe-shaped structure inlet, the proximal end, the sleeve structure, the sample pool, the sample outflow opening and the far end of the sampling connection structure inserted into the sampling head, the brackets arranged on the side of the sampling connection structure and the
  • the sampling head located at the front end of the sampling structure is inserted into the pipe-shaped structure and allows the liquid phase on the sampling head to pass through the sample pool,
  • the sample outflow opening flows into the sample pad of the detection reagent strip to carry out the working structure of the detection reaction, and the observation window located in the sleeve tube of the detection buckle.
  • the detection reagent strip is selected from at least one of colloidal gold immunoassay, fluorescent immunoassay, quantum dot immunoassay, dot immunoassay, and chemiluminescence immunoassay.
  • the 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 fast 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 sample outflow opening, and then flows through the binding pad, nitrocellulose membrane pad, and absorbent paper 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 above-mentioned rapid detection structure integrating column-push sampling and detection includes a detection sleeve, a detection reagent strip installed inside the detection sleeve, a sampling connection structure located at the end of the detection reagent strip, and a detachable structure that can be formed with the sampling connection structure.
  • the sampling structure of the loaded structure includes a detection sleeve, a detection reagent strip installed inside the detection sleeve, a sampling connection structure located at the end of the detection reagent strip, and a detachable structure that can be formed with the sampling connection structure.
  • the rapid detection structure is a columnar structure, and the sampling head is inserted into the detection sleeve in a columnar pushing manner to complete the detection, wherein the sampling connection structure is connected to the detection sleeve;
  • the detection reagent strip is sequentially provided with a sample pad, a marker binding pad, a nitrocellulose membrane pad and an absorbent paper pad in the direction in which the sampling structure advances;
  • sampling head can be inserted into the sampling connection structure, and the sampling connection structure is provided with a sample outflow opening facing the sample pad of the detection reagent strip so that the liquid phase to be tested flows to the sample pad;
  • the sampling structure is a plug-in structure provided with a sampling head and a sampling handle, wherein a blocking structure is provided between the sampling head and the sampling handle to prevent backflow of the liquid phase to be tested;
  • sampling head is inserted into the sampling connection structure, the end of the sampling head inserted into the sampling connection structure is squeezed, and the position of the sampling connection structure facing the insertion direction of the sampling head is provided with the seal Sleeve structure matching the plugging structure to prevent liquid phase reflux.
  • 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 sensitivity of the existing detection reagent is improved.
  • the sampling connection structure adopted in the present invention is a pipe-like structure, the middle section of the pipe is provided with a sample pool and a sample outflow opening, the end of the sample pad of the detection reagent strip is located in the sample pool, and the inner diameter of the pipe at the far end of the pipe-like structure is smaller than the above-mentioned
  • the outer diameter of the sampling head during the insertion process of the sampling head, the distal pipe of the pipe-like structure squeezes the sampling head, so that the liquid phase to be tested can quickly flow to the sample pad of the detection reagent strip, and the sampling head is quickly pushed forward to accelerate The label on the binding pad is released to speed up the detection speed and improve 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 a structural schematic diagram of the longitudinal section of the overall structure of the present invention
  • Fig. 2 is a schematic diagram 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 detachable structure of the present invention.
  • Fig. 6 is a schematic diagram of the structure of the detection aid liquid phase of the present invention.
  • the rapid detection structure of the present invention includes a sampling structure 1 , a sampling connection structure 2 , a bracket 3 , a detection reagent strip 4 , and a detection buckle sleeve 5 .
  • the rapid detection structure is set upright, the sampling structure 1 is located at the lower part; the detection reagent strip 4 is located on the upper side, supported by the bracket 3, and the outside is protected by the detection buckle sleeve 5; the sampling structure 1 and the detection reagent strip 4 are detachable , both sampling and detection processes can be completed on the fast detection structure of the present invention.
  • sampling structure 1 of the present invention comprises sampling handle 6, plugging structure 7, sampling head 8, sampling head water-absorbing layer 19, sampling rod 25, wherein sampling handle 6 and sampling The rod 25 is connected, the sampling rod 25 is connected with the sampling head 8, the sealing structure 7 is located between the sampling rod 25 and the sampling head 8, and the sampling head 8 is covered with a sampling head water-absorbing layer 19 made of water-absorbing material.
  • the blocking structure 7 can prevent the backflow of the liquid phase to be tested.
  • the rapid detection mechanism of the present invention also includes a test aid liquid phase, which includes a test aid solution 23 and a test aid solution container 24 for placing the test aid solution 23, wherein the test aid solution 23 is a buffered saline solution containing casein.
  • the sampling handle 6 is placed at the sampling place, and the sampling head water-absorbing layer 19 can directly absorb the sample to be tested, and the sampling is completed. If collecting a saliva sample, the sampling head 8 is put into the oral cavity; Put it into the blood; if the urine sample is collected, the sampling head 8 is put into the urine.
  • the sampling head 8 can be moistened with the test aid solution 23 placed in the test aid liquid container 24, and then sampled and tested; The sampling head 8 is immersed in the detection aid solution 23 for elution and mixing, and then for detection.
  • the sampling connection structure 2 of the present invention includes a pipe-like structure 9, a pipe structure inlet 10, a pipe structure proximal end 11, a sleeve structure 12, a sample pool 13, a sample outflow opening 14, and a pipe structure distal end 15.
  • sampling head 8 enters from the pipe structure inlet 10 of the pipe-like structure, passes through the near end 11 of the pipe structure, the sleeve structure 12, the sample pool 13, the sample outflow opening 14, and the pipe structure From the far end 15 to the blind end 18 of the pipe structure, the sampling head 8 passes through the above-mentioned path after sampling, so that the water-absorbing layer 19 of the sampling head releases the liquid phase to be tested by extrusion, and the detection is completed.
  • the sleeve structure 12, the blocking structure 7 and the proximal end 11 of the pipeline structure jointly form a structure for preventing the backflow of the liquid phase to be tested.
  • the detection reagent strip 4 of the present invention includes a sample pad 16, a nitrocellulose membrane pad 20, an absorbent paper pad 21, and a marker binding pad 22, and the bracket 3 is pasted with the sample pad 16. Marker binding pad 22 , nitrocellulose membrane pad 20 , absorbent paper pad 21 , check the detection result on the detection reagent strip 4 through the observation window 17 .
  • the detachable structure of the present invention includes the sampling handle 6 of the sampling structure 1, the sealing structure 7, the sampling head 8, the sampling head water-absorbing layer 19 and the pipeline of the sampling connection structure 2 shape structure 9, pipeline structure inlet 10, pipeline structure proximal end 11, sleeve structure 12, sample pool 13, sample outflow opening 14, pipeline structure far-end 15, pipeline structure blind end 18, wherein the sampling blocking structure of sampling structure 1 7.
  • sampling head 8 and the sampling head water-absorbing layer 19 pass through the pipeline structure inlet 10 of the sampling connection structure 2, the proximal end 11 of the pipeline structure, the sleeve structure 12, the sample pool 13, the sample outflow opening 14, the distal end 15 of the pipeline structure, and the pipeline structure
  • the blind end 18 is inserted or withdrawn to complete the detection process.
  • the integrated structure of the rapid detection structure is that the sampling structure 1 that can form a detachable connection with the sampling connection structure (2) includes a sampling handle 6, a blocking structure 7 arranged on the sampling handle and The sampling head 8, the inlet 10, the proximal end 11, the sleeve structure 12, the sample pool 13, the sample outflow opening 14 and the distal end 15 of the pipe-like structure 9 of the sampling connection structure 2 inserted into the sampling head are arranged on the sampling head.
  • the detection buckle sleeve 5 Connect the bracket 3 on the side of the structure 2 and the detection reagent strip 4 placed on the bracket 3 with the sample pad 16 adjacent to the sample outflow opening 14 of the sample pool 13, the detection buckle sleeve 5, and the sampling head located at the front end of the sampling structure 8 is inserted into the pipe-like structure 9 and allows the liquid phase on the sampling head to flow into the detection reagent strip sample pad 16 through the sample pool 13 and the sample outflow opening 14 to perform a detection reaction, and the observation window 17 located at the detection buckle sleeve 5 .
  • the rapid detection structure of the present invention is a colloidal gold immunodetection structure
  • the detection reagent strip 4 is prepared by the colloidal gold method, and the sample pad 16, which is coated with the colloidal gold marker, is pasted successively on the PVC film.
  • the detection reagent strip 4 is prepared by the fluorescent immunoassay, and is prepared on PVC
  • a sample pad 16 , a fluorescent microsphere binding pad coated with a fluorescent marker, a nitrocellulose membrane pad 20 coated with a non-labeled capture reagent, and an absorbent paper pad 21 are pasted on the negative in sequence.
  • sampling structure 1 When in use, take off the sampling structure 1, hold the sampling handle 6, take a sample with the sampling head 8, then insert the sampling head 8 into the pipeline structure 9 through the pipeline structure inlet 10, and the sample pool 13 and the sample outflow opening 14 enter the pipeline structure far away end 15 and the blind end 18 of the pipeline structure, at this time, the sampling head 8 is squeezed, and the liquid phase sample collected on the water-absorbing layer 19 of the sampling head flows to the sample pad 16 of the detection reagent strip 4 through the sample outflow opening 14, and the detection reaction begins , and then read the result.
  • 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 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 commercially available Lambert AFS-100 fluorescence detector is used.
  • the ratio of the fluorescence luminescence value of the detection line T on the test reagent strip to the fluorescence value of the quality control line C is greater than 0.02, it is positive; the ratio of the fluorescence luminescence value of the detection line T to the quality control line C on the detection reagent strip is less than or equal to 0.02 , 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.

Abstract

A column push type sampling and detection integrated rapid detection structure, comprising a detection sleeve, a detection reagent strip (4) positioned in the detection sleeve, a sampling connection structure (2) positioned at a starting end of the detection reagent strip (4), and a sampling structure (1) capable of forming a detachable structure with the sampling connection structure (2). The sampling connection structure (2) is a tubular structure provided with a pipe-like structure (9), a sample pool (13), and a sample outflow opening (14). The sampling structure (1) is an insertion structure provided with a sampling head (8), a plugging structure (7), and a sampling handle (6). The column push type sampling and detection integrated rapid detection structure can be used for development of a plurality of rapid immunodetection products such as colloidal gold, fluorescence immunoassay, and chemiluminescence, and improves the detection efficiency, convenience and accuracy of immunodetection products.vvvvvvv

Description

一种柱推式采样检测一体化的快速检测结构及其应用A rapid detection structure with integrated column push sampling and detection and its application 技术领域technical field
本发明涉及医疗器械技术领域，尤其涉及一种柱推式采样检测一体化的快速检测结构及其应用。The invention relates to the technical field of medical devices, in particular to a rapid detection structure integrating column-push sampling and detection and its application.
背景技术Background technique
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。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. Products of colloidal gold and fluorescent lateral flow chromatographic immunoassay technology are the most widely used, but the methods used Generally, there are two or more steps, such as sampling, sample addition, observation, or sampling, dilution extraction, sample addition, observation, etc. Therefore, the development of detection technologies that are more convenient, fast, high-performance and can improve anti-pollution protection , will contribute to the popularization of clinical testing products, improve the quality of diagnosis, treatment and prevention, and have important application value.
发明内容Contents of the invention
本发明的目的是提供一种具有便捷、快速、防止污染等的特点且具有良好检测质量的可作为现场或家庭检测使用的快速检测结构。The object of the present invention is to provide a rapid detection structure which has the characteristics of convenience, speed, pollution prevention, etc. and has good detection quality and can be used as on-site or home detection.
针对上述目的，本发明提供的一种柱推式采样检测一体化的快速检测结构,包括检测套筒、位于检测套筒内的检测试剂条、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，特征在于：In view of the above purpose, the present invention provides a column-push type sampling detection integrated rapid detection structure, including a detection sleeve, a detection reagent strip located in the detection sleeve, a sampling connection structure located at the starting end of the detection reagent strip, and can be connected with The sampling connection structure forms a detachable sampling structure, characterized in that:
1)所述快速检测结构为柱状结构，采用将采样头以柱状推进式向检测套筒内插入的操作方式完成检测，其中采样结构位于底部，向上与采样连接结构形成可拆装式连接，采样连接结构向上与所述检测套筒连接；1) The rapid detection structure is a columnar structure, and the detection is completed by inserting the sampling head into the detection sleeve in a columnar push-type manner. The sampling structure is located at the bottom, and forms a detachable connection with the sampling connection structure upwards. The connection structure is upwardly connected with the detection sleeve;
2)所述检测试剂条设置于所述检测套筒内，从下端向上端依次包括样品垫、标记物结合垫、硝酸纤维素膜垫和吸水纸垫；2) The detection reagent strip is arranged in the detection sleeve, and sequentially includes a sample pad, a marker binding pad, a nitrocellulose membrane pad and an absorbent paper pad from the lower end to the upper end;
3)所述采样连接结构为一与所述检测试剂条呈上下方向同一走向的管状结构，远端为盲端，近端设有开口，中段设置有样本池和样本流出开口，设置于所述检测试剂条的侧面，其中样本池和样本流出开口与所述检测试剂条的样品垫相邻接相通；3) The sampling connection structure is a tubular structure in the same vertical direction as the detection reagent strip, the distal end is a blind end, the proximal end is provided with an opening, and the middle section is provided with a sample pool and a sample outflow opening, which are arranged on the The side of the detection reagent strip, wherein the sample pool and the sample outflow opening are adjacent to and communicated with the sample pad of the detection reagent strip;
4)所述采样结构为设置有采样头和采样手柄的插入式结构，其中采样头与采样手柄的连接部位设置有防止液相返流的封堵结构；4) The sampling structure is a plug-in structure provided with a sampling head and a sampling handle, wherein the connection between the sampling head and the sampling handle is provided with a blocking structure to prevent liquid phase reflux;
5)所述采样头经所述采样连接结构的开口插入至所述管状结构内，在远端形成挤压，所述管状结构的近端设置有与所述封堵结构相匹配的防止液相返流的套筒结构。5) The sampling head is inserted into the tubular structure through the opening of the sampling connection structure, and is squeezed at the far end, and the proximal end of the tubular structure is provided with an anti-liquid phase that matches the blocking structure. Backflow sleeve structure.
上述的快速检测结构中，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。吸水材料大体分为天然及改性高分子高吸水性树脂和人工合成吸水性树脂，包括淀粉系列、纤维素系列、其他天然产物系列、聚乙烯酸盐系列、聚乙烯醇系列和聚氧乙烯系列等，其中部分聚乙烯醇系列产品拥有干燥变硬、吸水变软的特性。聚乙烯醇(PVA)吸水海绵不仅具有优良的化学稳定性、吸水功能和优质物理性能，同时具有吸水速率快、吸液倍率高、吸水后柔软等特点，在日用清洁、医疗卫生等领域广泛使用。In the above rapid detection structure, the sampling head is a detection sampling swab-like structure provided with a water-absorbing material structure. Water-absorbing materials are roughly divided into natural and modified polymer superabsorbent resins and artificially synthesized water-absorbing resins, including starch series, cellulose series, other natural product series, polyvinyl salt series, polyvinyl alcohol series and polyoxyethylene series etc. Some of the polyvinyl alcohol series products have the characteristics of drying and hardening, and absorbing water and softening. Polyvinyl alcohol (PVA) absorbent sponge not only has excellent chemical stability, water absorption function and high-quality physical properties, but also has the characteristics of fast water absorption rate, high liquid absorption rate, and softness after absorbing water. It is widely used in daily cleaning, medical and health fields, etc. use.
上述的快速检测结构中，所述管道状结构的样本池和样本流出开口部位的远端的管道内径小于其近端的管道内径，使用时将所述采样头插入管道状结构内，插入过程中管道状结构对采样头形成挤压。。In the above-mentioned rapid detection structure, the inner diameter of the pipe at the far end of the sample pool of the pipe-shaped structure and the sample outflow opening is smaller than the inner diameter of the pipe at the proximal end, and the sampling head is inserted into the pipe-shaped structure during use. The pipe-like structure forms an extrusion on the sampling head. .
上述的快速检测结构中，设置于所述采样连接结构上的防止液相返流的结构由设置于采样头与采样手柄的连接部位的弹性垫圈和设置于所述管状结构远端的套筒结构组成，使用时所述弹性垫圈在所述套筒结构内上下滑动。In the above-mentioned rapid detection structure, the structure for preventing liquid phase backflow arranged on the sampling connection structure consists of an elastic washer arranged at the connection part between the sampling head and the sampling handle and a sleeve structure arranged at the distal end of the tubular structure In use, the elastic washer slides up and down in the sleeve structure.
上述的快速检测结构中，所述检测试剂条的样品垫的末端置于样本池内。In the above rapid detection structure, the end of the sample pad of the detection reagent strip is placed in the sample pool.
上述的快速检测结构中，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。In the above rapid detection structure, the rapid detection structure includes a test aid liquid phase, which is composed of a test aid solution and a container, and the test aid solution is a buffered saline solution containing casein.
上述的快速检测结构中，所述快速检测结构的一体化结构，从下至上依次为，与采样连接结构可形成可拆装式连接的采样结构包括采样手柄、设置于采样手柄上的封堵 结构和采样头，供采样头插入的所述采样连接结构的管道状结构入口、近端、套筒结构、样本池、样本流出开口和远端，设置于所述采样连接结构侧面的托槽以及置于托槽上的以样品垫临接样本池的样本流出开口的检测试剂条，检测扣卡套管，位于采样结构前端的采样头插入管道状结构且允许采样头上的液相经样本池、样本流出开口流入检测试剂条样品垫而进行检测反应的工作结构，以及位于检测扣卡套管的观察窗。In the above-mentioned rapid detection structure, the integrated structure of the rapid detection structure, from bottom to top, is that the sampling structure that can form a detachable connection with the sampling connection structure includes a sampling handle and a blocking structure arranged on the sampling handle and the sampling head, the pipe-shaped structure inlet, the proximal end, the sleeve structure, the sample pool, the sample outflow opening and the far end of the sampling connection structure inserted into the sampling head, the brackets arranged on the side of the sampling connection structure and the placement The detection reagent strip on the bracket is connected to the sample outflow opening of the sample pool with the sample pad, and the buckle sleeve is detected. The sampling head located at the front end of the sampling structure is inserted into the pipe-shaped structure and allows the liquid phase on the sampling head to pass through the sample pool, The sample outflow opening flows into the sample pad of the detection reagent strip to carry out the working structure of the detection reaction, and the observation window located in the sleeve tube of the detection buckle.
上述的快速检测结构中，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。In the above rapid detection structure, the detection reagent strip is selected from at least one of colloidal gold immunoassay, fluorescent immunoassay, quantum dot immunoassay, dot immunoassay, and chemiluminescence immunoassay.
上述的快速检测结构中，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。In the above-mentioned rapid detection structure, the samples collected by the sampling structure include one or more of saliva, sputum, nasal cavity fluid, urine, blood, and excretion.
上述的快速检测结构中，所述快速检测结构的操作使用，包括如下步骤：In the above-mentioned fast detection structure, the operation and use of the fast detection structure includes the following steps:
1)从快速检测结构上取下采样结构；1) Take off the sampling structure from the fast detection structure;
2)将采样头伸入取样部位内，完成取样；2) Insert the sampling head into the sampling site to complete the sampling;
3)将采样头经所述采样连接结构的管道状结构入口插入至管道状结构远端；3) inserting the sampling head into the distal end of the pipe-like structure through the inlet of the pipe-like structure of the sampling connection structure;
4)静置快速检测结构，采样头所含有的液相经样本流出开口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、吸水纸垫，完成检测。4) Put the rapid detection structure still, the liquid phase contained in the sampling head flows into the sample pad of the detection reagent strip through the sample outflow opening, and then flows through the binding pad, nitrocellulose membrane pad, and absorbent paper pad to complete the detection.
5)从观察窗读取检测结果。5) Read the test result from the observation window.
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。The rapid detection structure of the present invention can be used for sampling and detection of samples from various sources. For liquid samples, such as saliva, blood, urine, etc., it can be directly sampled and detected. For non-liquid samples, such as nasal cavity, oropharynx, skin, secretions, etc. , You can soak the sampling head in the test aid solution first and then sample, or take a sample first, then put the sampling head in the test aid solution, extract and mix before testing.
上述一种柱推式采样检测一体化的快速检测结构，包括检测套筒、安装于检测套筒内部的检测试剂条、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，The above-mentioned rapid detection structure integrating column-push sampling and detection includes a detection sleeve, a detection reagent strip installed inside the detection sleeve, a sampling connection structure located at the end of the detection reagent strip, and a detachable structure that can be formed with the sampling connection structure. The sampling structure of the loaded structure,
所述快速检测结构为柱状结构，所述采样头以柱状推进式向所述检测套筒内插入的操作方式完成检测，其中所述采样连接结构与所述检测套筒连接；The rapid detection structure is a columnar structure, and the sampling head is inserted into the detection sleeve in a columnar pushing manner to complete the detection, wherein the sampling connection structure is connected to the detection sleeve;
2)所述检测试剂条以采样结构推进的方向依次设置有样品垫、标记物结合垫、 硝酸纤维素膜垫和吸水纸垫；2) The detection reagent strip is sequentially provided with a sample pad, a marker binding pad, a nitrocellulose membrane pad and an absorbent paper pad in the direction in which the sampling structure advances;
3)所述采样头可插入所述采样连接结构内，所述采样连接结构朝向所述检测试剂条的样品垫的位置开设有使待检液相流至所述样品垫的样本流出开口；3) The sampling head can be inserted into the sampling connection structure, and the sampling connection structure is provided with a sample outflow opening facing the sample pad of the detection reagent strip so that the liquid phase to be tested flows to the sample pad;
4)所述采样结构为设置有采样头和采样手柄的插入式结构，其中采样头与采样手柄之间设置有防止待检液相返流的封堵结构；4) The sampling structure is a plug-in structure provided with a sampling head and a sampling handle, wherein a blocking structure is provided between the sampling head and the sampling handle to prevent backflow of the liquid phase to be tested;
5)所述采样头插入至所述采样连接结构内，所述采样头插入所述采样连接结构的端部受到挤压，所述采样连接结构朝向采样头插入方向的位置设置有与所述封堵结构相匹配的防止液相返流的套筒结构。5) The sampling head is inserted into the sampling connection structure, the end of the sampling head inserted into the sampling connection structure is squeezed, and the position of the sampling connection structure facing the insertion direction of the sampling head is provided with the seal Sleeve structure matching the plugging structure to prevent liquid phase reflux.
本发明所述快速检测结构在快速检测产品开发中的应用。The application of the rapid detection structure of the invention in the development of rapid detection products.
本发明由于采取以上技术方案，其具有以下优点：The present invention has the following advantages due to the adoption of the above technical scheme:
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灵敏度。1. 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. At the same time, the background noise interference of the solid-phase membrane is reduced, the detection sensitivity is improved, and the sensitivity of the existing detection reagent is improved.
2、本发明所采用的采样连接结构为管道状结构，管道中段设有样本池和样本流出开口，检测试剂条的样品垫端部位于样本池内，且管道状结构远端的管道内径小于所述采样头的外径，在采样头插入过程中管道状结构的远端管道对采样头挤压，使待检液相能够快速流至检测试剂条的样品垫上，同时采样头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。2. The sampling connection structure adopted in the present invention is a pipe-like structure, the middle section of the pipe is provided with a sample pool and a sample outflow opening, the end of the sample pad of the detection reagent strip is located in the sample pool, and the inner diameter of the pipe at the far end of the pipe-like structure is smaller than the above-mentioned The outer diameter of the sampling head, during the insertion process of the sampling head, the distal pipe of the pipe-like structure squeezes the sampling head, so that the liquid phase to be tested can quickly flow to the sample pad of the detection reagent strip, and the sampling head is quickly pushed forward to accelerate The label on the binding pad is released to speed up the detection speed and improve the detection sensitivity.
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。3. 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.
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。4. 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.
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。5. 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.
附图说明Description of drawings
图1为本发明的整体结构纵切面结构示意图；Fig. 1 is a structural schematic diagram of the longitudinal section of the overall structure of the present invention;
图2为本发明的快速检测结构示意图；Fig. 2 is a schematic diagram of the rapid detection structure of the present invention;
图3为本发明的采样结构示意图；Fig. 3 is a schematic diagram of a sampling structure of the present invention;
图4为本发明的采样连接结构示意图；Fig. 4 is a schematic diagram of the sampling connection structure of the present invention;
图5为本发明的拆装式结构示意图；Fig. 5 is a schematic diagram of a detachable structure of the present invention;
图6为本发明的助检液相结构示意图。Fig. 6 is a schematic diagram of the structure of the detection aid liquid phase of the present invention.
图中标记如下：The markings in the figure are as follows:
采样结构1；采样连接结构2；托槽3；检测试剂条4；检测扣卡套管5；采样手柄6；封堵结构7；采样头8；管道状结构9；管道结构入口10；管道结构近端11、套筒结构12、样本池13、样本流出开口14；管道结构远端15；样品垫16；观察窗17；管道结构盲端18；采样头吸水层19；硝酸纤维素膜垫20；吸水纸垫21；标记物结合垫22；助检溶液23；助检液容器24；采样杆25。 Sampling structure 1; Sampling connection structure 2; Bracket 3; Detection reagent strip 4; Detection buckle sleeve 5; Sampling handle 6; Blocking structure 7; Near end 11, sleeve structure 12, sample pool 13, sample outflow opening 14; distal end of pipeline structure 15; sample pad 16; observation window 17; blind end of pipeline structure 18; absorbent layer 19 of sampling head; nitrocellulose membrane pad 20 Absorbent paper pad 21; marker binding pad 22; test solution 23; test solution container 24; sampling rod 25.
具体实施方式Detailed ways
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。In order to further illustrate the technical means and effects adopted by the present invention to achieve the intended purpose, the following embodiments will further illustrate the present invention in conjunction with the accompanying drawings, but the present invention is not limited to the following description.
如图1、图2所示，本发明快速检测结构包括采样结构1、采样连接结构2、托槽3、检测试剂条4、检测扣卡套管5。快速检测结构呈直立设置，采样结构1位于下部；检测试剂条4位于上部侧面，由托槽3支撑，外部由检测扣卡套管5保护；采样结构1与检测试剂条4之间可拆装，采样与检测过程都可以在本发明的快速检测结构上完成。As shown in FIG. 1 and FIG. 2 , the rapid detection structure of the present invention includes a sampling structure 1 , a sampling connection structure 2 , a bracket 3 , a detection reagent strip 4 , and a detection buckle sleeve 5 . The rapid detection structure is set upright, the sampling structure 1 is located at the lower part; the detection reagent strip 4 is located on the upper side, supported by the bracket 3, and the outside is protected by the detection buckle sleeve 5; the sampling structure 1 and the detection reagent strip 4 are detachable , both sampling and detection processes can be completed on the fast detection structure of the present invention.
如图1、图2、图3、图6所示，本发明采样结构1包括采样手柄6、封堵结构7、采样头8、采样头吸水层19、采样杆25，其中采样手柄6与采样杆25连接，采样杆25与采样头8连接，封堵结构7位于采样杆25与采样头8之间，采样头8外侧包被有由吸水材料制成的采样头吸水层19。检测加样时，封堵结构7可以防止待检液相 的返流。本发明的快速检测机构还包括助检液相，助检液相包括助检溶液23以及放置助检溶液23的助检液容器24，其中助检溶液23为含有酪蛋白的缓冲盐溶液。采样时将采样手柄6置于采样处，采样头吸水层19可以直接吸取待检样本，完成采样，如采集唾液样本，则将采样头8放入口腔内；如采集血液样本则将采样头8放入血液内；如采集尿液样本，则将采样头8放入尿液内。采集液相不充分的样本，如在鼻腔取样，可将采样头8先用放置于助检液容器24内的助检溶液23湿润，然后进行采样，进行检测；或者是，先采样，然后将采样头8浸入助检溶液23内，进行洗脱混合，然后进行检测。As shown in Fig. 1, Fig. 2, Fig. 3, Fig. 6, sampling structure 1 of the present invention comprises sampling handle 6, plugging structure 7, sampling head 8, sampling head water-absorbing layer 19, sampling rod 25, wherein sampling handle 6 and sampling The rod 25 is connected, the sampling rod 25 is connected with the sampling head 8, the sealing structure 7 is located between the sampling rod 25 and the sampling head 8, and the sampling head 8 is covered with a sampling head water-absorbing layer 19 made of water-absorbing material. When testing and adding samples, the blocking structure 7 can prevent the backflow of the liquid phase to be tested. The rapid detection mechanism of the present invention also includes a test aid liquid phase, which includes a test aid solution 23 and a test aid solution container 24 for placing the test aid solution 23, wherein the test aid solution 23 is a buffered saline solution containing casein. When sampling, the sampling handle 6 is placed at the sampling place, and the sampling head water-absorbing layer 19 can directly absorb the sample to be tested, and the sampling is completed. If collecting a saliva sample, the sampling head 8 is put into the oral cavity; Put it into the blood; if the urine sample is collected, the sampling head 8 is put into the urine. Collect samples with insufficient liquid phase, such as sampling in the nasal cavity, the sampling head 8 can be moistened with the test aid solution 23 placed in the test aid liquid container 24, and then sampled and tested; The sampling head 8 is immersed in the detection aid solution 23 for elution and mixing, and then for detection.
如图1、图4所示，本发明采样连接结构2包括管道状结构9、管道结构入口10、管道结构近端11、套筒结构12、样本池13、样本流出开口14、管道结构远端15、观察窗17、管道结构盲端18，其中采样头8从管道状结构的管道结构入口10进入，经管道结构近端11、套筒结构12、样本池13、样本流出开口14、管道结构远端15直至管道结构盲端18，采样头8在采样后经上述路径，使得采样头吸水层19通过挤压释放待检液相，完成检测。套筒结构12、封堵结构7和管道结构近端11共同形成防止待检液相返流的结构。As shown in Figures 1 and 4, the sampling connection structure 2 of the present invention includes a pipe-like structure 9, a pipe structure inlet 10, a pipe structure proximal end 11, a sleeve structure 12, a sample pool 13, a sample outflow opening 14, and a pipe structure distal end 15. Observation window 17, pipe structure blind end 18, wherein the sampling head 8 enters from the pipe structure inlet 10 of the pipe-like structure, passes through the near end 11 of the pipe structure, the sleeve structure 12, the sample pool 13, the sample outflow opening 14, and the pipe structure From the far end 15 to the blind end 18 of the pipe structure, the sampling head 8 passes through the above-mentioned path after sampling, so that the water-absorbing layer 19 of the sampling head releases the liquid phase to be tested by extrusion, and the detection is completed. The sleeve structure 12, the blocking structure 7 and the proximal end 11 of the pipeline structure jointly form a structure for preventing the backflow of the liquid phase to be tested.
如图1、图2、图4所示，本发明检测试剂条4包括样品垫16、硝酸纤维素膜垫20、吸水纸垫21、标记物结合垫22，托槽3上以此粘贴样品垫16、标记物结合垫22、硝酸纤维素膜垫20、吸水纸垫21，通过观察窗17查看检测试剂条4上的检测结果。As shown in Figures 1, 2 and 4, the detection reagent strip 4 of the present invention includes a sample pad 16, a nitrocellulose membrane pad 20, an absorbent paper pad 21, and a marker binding pad 22, and the bracket 3 is pasted with the sample pad 16. Marker binding pad 22 , nitrocellulose membrane pad 20 , absorbent paper pad 21 , check the detection result on the detection reagent strip 4 through the observation window 17 .
如图1、图2、图5所示，本发明的拆装式结构，包括采样结构1的采样手柄6、封堵结构7、采样头8、采样头吸水层19和采样连接结构2的管道状结构9、管道结构入口10、管道结构近端11、套筒结构12、样本池13、样本流出开口14、管道结构远端15、管道结构盲端18，其中采样结构1的采样封堵结构7、采样头8和采样头吸水层19经采样连接结构2的管道结构入口10、管道结构近端11、套筒结构12、样本池13、样本流出开口14、管道结构远端15、管道结构盲端18插入或撤出，完成检测过程。As shown in Fig. 1, Fig. 2 and Fig. 5, the detachable structure of the present invention includes the sampling handle 6 of the sampling structure 1, the sealing structure 7, the sampling head 8, the sampling head water-absorbing layer 19 and the pipeline of the sampling connection structure 2 shape structure 9, pipeline structure inlet 10, pipeline structure proximal end 11, sleeve structure 12, sample pool 13, sample outflow opening 14, pipeline structure far-end 15, pipeline structure blind end 18, wherein the sampling blocking structure of sampling structure 1 7. The sampling head 8 and the sampling head water-absorbing layer 19 pass through the pipeline structure inlet 10 of the sampling connection structure 2, the proximal end 11 of the pipeline structure, the sleeve structure 12, the sample pool 13, the sample outflow opening 14, the distal end 15 of the pipeline structure, and the pipeline structure The blind end 18 is inserted or withdrawn to complete the detection process.
所述快速检测结构的一体化结构，从下至上依次为，与采样连接结构(2)可形成可拆装式连接的采样结构1包括采样手柄6、设置于采样手柄上的封堵结构7和采样头8，供采样头插入的所述采样连接结构2的管道状结构9入口10、近端11、套筒结构12、样本池13、样本流出开口14和远端15，设置于所述采样连接结构2侧面的托槽3以及置于托槽3上的以样品垫16临接样本池13的样本流出开口14的检测试剂条4，检测扣卡套管5，位于采样结 构前端的采样头8插入管道状结构9且允许采样头上的液相经样本池13、样本流出开口14流入检测试剂条样品垫16而进行检测反应的工作结构，以及位于检测扣卡套管5的观察窗17。The integrated structure of the rapid detection structure, from bottom to top, is that the sampling structure 1 that can form a detachable connection with the sampling connection structure (2) includes a sampling handle 6, a blocking structure 7 arranged on the sampling handle and The sampling head 8, the inlet 10, the proximal end 11, the sleeve structure 12, the sample pool 13, the sample outflow opening 14 and the distal end 15 of the pipe-like structure 9 of the sampling connection structure 2 inserted into the sampling head are arranged on the sampling head. Connect the bracket 3 on the side of the structure 2 and the detection reagent strip 4 placed on the bracket 3 with the sample pad 16 adjacent to the sample outflow opening 14 of the sample pool 13, the detection buckle sleeve 5, and the sampling head located at the front end of the sampling structure 8 is inserted into the pipe-like structure 9 and allows the liquid phase on the sampling head to flow into the detection reagent strip sample pad 16 through the sample pool 13 and the sample outflow opening 14 to perform a detection reaction, and the observation window 17 located at the detection buckle sleeve 5 .
这样在实际操作时，当本发明的快速检测结构为胶体金免疫检测结构时，检测试剂条4用胶体金法制备，在PVC底片上依次粘贴有样品垫16、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20和吸水纸垫21；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4用荧光免疫法制备，在PVC底片上依次粘贴有样品垫16、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20和吸水纸垫21。使用时，取下采样结构1，手持采样手柄6，用采样头8取样，然后将采样头8通过管道结构入口10插入至管道状结构9内，样本池13、样本流出开口14进入管道结构远端15、管道结构盲端18内，此时采样头8被挤压，采样头吸水层19上采集的液相样本，经样本流出开口14流至检测试剂条4的样品垫16，开始检测反应，然后读取结果。In actual operation, when the rapid detection structure of the present invention is a colloidal gold immunodetection structure, the detection reagent strip 4 is prepared by the colloidal gold method, and the sample pad 16, which is coated with the colloidal gold marker, is pasted successively on the PVC film. Colloidal gold binding pads, nitrocellulose membrane pads 20 and absorbent paper pads 21 coated with non-labeled capture reagents; when the rapid detection structure of the present invention is a fluorescent immunoassay structure, the detection reagent strip 4 is prepared by the fluorescent immunoassay, and is prepared on PVC A sample pad 16 , a fluorescent microsphere binding pad coated with a fluorescent marker, a nitrocellulose membrane pad 20 coated with a non-labeled capture reagent, and an absorbent paper pad 21 are pasted on the negative in sequence. When in use, take off the sampling structure 1, hold the sampling handle 6, take a sample with the sampling head 8, then insert the sampling head 8 into the pipeline structure 9 through the pipeline structure inlet 10, and the sample pool 13 and the sample outflow opening 14 enter the pipeline structure far away end 15 and the blind end 18 of the pipeline structure, at this time, the sampling head 8 is squeezed, and the liquid phase sample collected on the water-absorbing layer 19 of the sampling head flows to the sample pad 16 of the detection reagent strip 4 through the sample outflow opening 14, and the detection reaction begins , and then read the result.
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。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.
实验一：免疫胶体金法新冠病毒抗原快速检测实验：Experiment 1: Rapid detection of new coronavirus antigen by immunocolloidal gold method:
一、检测试剂条制备：1. Detection reagent strip preparation:
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纸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。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. Paste absorbent paper pads and colloidal gold marker pads on both ends of the nitrocellulose membrane pad printing membrane, and paste sample pads on the side of the colloidal gold marker pads. Place the pasted test piece on the strip cutting machine and cut into 3.5mm test reagent strips.
二、本发明快速检测结构制备：Two, the rapid detection structure preparation of the present invention:
采用Solidworks设计本发明快速检测结构的采样结构、采样连接结构和检测扣 卡套管，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。Using Solidworks to design the sampling structure, sampling connection structure and detection buckle sleeve of the present invention's rapid detection structure, and use 3D printing samples, paste the sponge sampling head on the sampling head fixed structure, and the prepared samples are used for experimental detection.
三、实验方法及结果：3. Experimental methods and results:
实验时取上述制备的检测试剂条和快速检测结构，装配成检测套装，将装配好的检测套装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。从检测套装上取下采样结构，将采样头用配置的S蛋白溶液浸润，然后经管状结构入口插入采样连接结构的管道状结构内，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。During the experiment, take the detection reagent strips and rapid detection structure prepared above, assemble them into a detection kit, put the assembled detection kit into an aluminum foil sealed bag with a desiccant, seal it on a sealing machine, and affix a label. Different concentrations of recombinant new coronavirus antigen S protein solutions were prepared with the saliva of healthy people. Remove the sampling structure from the detection kit, infiltrate the sampling head with the configured S protein solution, and then insert it into the pipe-shaped structure of the sampling connection structure through the inlet of the tubular structure, let it stand for 20 minutes, check the observation window, and read the detection reagent strip. color rendering results. 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. When the 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.
实验二：免疫荧光法新冠病毒抗原快速检测实验：Experiment 2: Immunofluorescence method for rapid detection of new coronavirus antigen:
一、检测试剂条制备：1. Detection reagent strip preparation:
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纸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的检测试剂条。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. Paste absorbent paper pads and fluorescent microsphere-labeled binding pads on both ends of the nitrocellulose membrane pad printing membrane, and paste sample pads on the side of the fluorescent microsphere-labeled binding pad. Place the pasted test piece on the strip cutter and cut it into 3.5mm test reagent strips.
二、本发明快速检测结构制备：Two, the rapid detection structure preparation of the present invention:
同“实验一”制备。Prepared with "Experiment 1".
三、荧光检测器：采用市售的蓝勃AFS-100荧光检测仪。3. Fluorescence detector: commercially available Lambert AFS-100 fluorescence detector is used.
四、实验方法及结果：4. Experimental methods and results:
实验时取上述制备的检测试剂条和快速检测结构，装配成检测套装，将装配好的检测套装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。从检测套装上取下采样结构，将采样头用配置的抗原S蛋白溶液浸润，然后经管道状结构入口插入采样连接结构的管道内，静置20分钟，将检测套筒置于荧光检测仪内，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。During the experiment, take the detection reagent strips and rapid detection structure prepared above, assemble them into a detection kit, put the assembled detection kit into an aluminum foil sealed bag with a desiccant, seal it on a sealing machine, and affix a label. Different concentrations of recombinant new coronavirus antigen S protein solutions were prepared with the saliva of healthy people. Remove the sampling structure from the detection kit, infiltrate the sampling head with the configured antigen S protein solution, then insert it into the pipe of the sampling connection structure through the inlet of the pipe-shaped structure, let it stand for 20 minutes, and place the detection sleeve in the fluorescence detector , start the detection, and read the fluorescence test result on the detection reagent strip. If the ratio of the fluorescence luminescence value of the detection line T on the test reagent strip to the fluorescence value of the quality control line C is greater than 0.02, it is positive; the ratio of the fluorescence luminescence value of the detection line T to the quality control line C on the detection reagent strip is less than or equal to 0.02 , is negative. When the 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.

Claims (12)

  1. 一种柱推式采样检测一体化的快速检测结构，包括检测套筒、位于检测套筒内的检测试剂条、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，特征在于：A rapid detection structure integrating column-push sampling and detection, including a detection sleeve, a detection reagent strip located in the detection sleeve, a sampling connection structure located at the beginning of the detection reagent strip, and a detachable connection structure that can be formed with the sampling connection structure. A sampling structure of structures, characterized by:
    1)所述快速检测结构为柱状结构，采用将采样头以柱状推进式向检测套筒内插入的操作方式完成检测，其中采样结构位于底部，向上与采样连接结构形成可拆装式连接，采样连接结构向上与所述检测套筒连接；1) The rapid detection structure is a columnar structure, and the detection is completed by inserting the sampling head into the detection sleeve in a columnar push-type manner. The sampling structure is located at the bottom, and forms a detachable connection with the sampling connection structure upwards. The connection structure is upwardly connected with the detection sleeve;
    2)所述检测试剂条设置于所述检测套筒内，从下端向上端依次包括样品垫、标记物结合垫、硝酸纤维素膜垫和吸水纸垫；2) The detection reagent strip is arranged in the detection sleeve, and sequentially includes a sample pad, a marker binding pad, a nitrocellulose membrane pad and an absorbent paper pad from the lower end to the upper end;
    3)所述采样连接结构为一与所述检测试剂条呈上下方向同一走向的管状结构，远端为盲端，近端设有开口，中段设置有样本池和样本流出开口，设置于所述检测试剂条的侧面，其中样本池和样本流出开口与所述检测试剂条的样品垫相邻接相通；3) The sampling connection structure is a tubular structure in the same vertical direction as the detection reagent strip, the distal end is a blind end, the proximal end is provided with an opening, and the middle section is provided with a sample pool and a sample outflow opening, which are arranged on the The side of the detection reagent strip, wherein the sample pool and the sample outflow opening are adjacent to and communicated with the sample pad of the detection reagent strip;
    4)所述采样结构为设置有采样头和采样手柄的插入式结构，其中采样头与采样手柄的连接部位设置有防止液相返流的封堵结构；4) The sampling structure is a plug-in structure provided with a sampling head and a sampling handle, wherein the connection between the sampling head and the sampling handle is provided with a blocking structure to prevent liquid phase reflux;
    5)所述采样头经所述采样连接结构的开口插入至所述管状结构内，在远端形成挤压，所述管状结构的近端设置有与所述封堵结构相匹配的防止液相返流的套筒结构。5) The sampling head is inserted into the tubular structure through the opening of the sampling connection structure, and is squeezed at the far end, and the proximal end of the tubular structure is provided with an anti-liquid phase that matches the blocking structure. Backflow sleeve structure.
  2. 如权利要求1所述快速检测结构，其特征在于，所述采样头吸收液相的一端设置有吸水性材料。The rapid detection structure according to claim 1, characterized in that, one end of the sampling head absorbing the liquid phase is provided with a water-absorbing material.
  3. 如权利要求1所述快速检测结构，其特征在于，所述采样头插入所述采样连接结构的过程中，所述采样连接结构的内径逐渐减小，使用时，所述采样头插入所述采样连接结构的过程中，所述采样连接结构内壁对采样头形成挤压。The fast detection structure according to claim 1, characterized in that, when the sampling head is inserted into the sampling connection structure, the inner diameter of the sampling connection structure gradually decreases, and when in use, the sampling head is inserted into the sampling connection structure. During the process of connecting the structure, the inner wall of the sampling connection structure forms a squeeze on the sampling head.
  4. 如权利要求1所述快速检测结构，其特征在于，设置于所述采样连接结构上的防止液相返流的结构由设置于采样头与采样手柄的连接部位的弹性垫圈和设置于所述管状结构远端的套筒结构组成，使用时所述弹性垫圈在所述套筒结构内上下滑动，所述封堵结构为弹性垫圈。The rapid detection structure according to claim 1, characterized in that the structure for preventing liquid phase reflux provided on the sampling connection structure is composed of an elastic washer provided at the connecting part of the sampling head and the sampling handle and provided at the tubular The distal end of the structure is composed of a sleeve structure. When in use, the elastic washer slides up and down inside the sleeve structure, and the blocking structure is an elastic washer.
  5. 如权利要求1所述快速检测结构，其特征在于，所述检测试剂条的样品垫的末端置于样本池内。The rapid detection structure according to claim 1, wherein the end of the sample pad of the detection reagent strip is placed in the sample pool.
  6. 如权利要求1所述快速检测结构，其特征在于，所述快速检测结构还包括助检液相，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。The rapid detection structure according to claim 1, characterized in that, the rapid detection structure also includes a test aid liquid phase, the test aid liquid phase is composed of a test aid solution and a container, and the test aid solution is a test solution containing casein buffered saline solution.
  7. 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，与采样连接结构形成可拆装式连接的采样结构包括采样手柄、设置于采样手柄上的封堵结构和采样头，供采样头插入的所述采样连接结构的管道状结构入口、近端、套筒结构、样本池、样本流出开口和远端，设置于所述采样连接结构侧面的托槽以及置于托槽上的以样品垫临接样本池的样本流出开口的检测试剂条，检测扣卡套管，位于采样结构前端的采样头插入管道状结构且允许采样头上的液相经样本池、样本流出开口流入检测试剂条样品垫而进行检测反应的工作结构，以及位于检测扣卡套管的观察窗。The rapid detection structure according to claim 1, characterized in that, the integrated structure of the rapid detection structure, from bottom to top, is that the sampling structure that forms a detachable connection with the sampling connection structure includes a sampling handle, and is arranged on the sampling The blocking structure and sampling head on the handle, the pipe-like structure inlet, the proximal end, the sleeve structure, the sample pool, the sample outflow opening and the distal end of the sampling connection structure inserted into the sampling head are arranged on the sampling connection structure The bracket on the side and the detection reagent strip placed on the bracket with the sample pad adjacent to the sample outflow opening of the sample pool, the detection buckle sleeve, the sampling head located at the front end of the sampling structure is inserted into the pipe-shaped structure and allows the The liquid phase flows into the sample pad of the detection reagent strip through the sample pool and the sample outflow opening to carry out the working structure of the detection reaction, and the observation window located in the detection buckle sleeve.
  8. 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。The rapid detection structure according to claim 1, wherein the detection reagent strip is selected from at least one of colloidal gold immunoassay, fluorescent immunoassay, quantum dot immunoassay, dot immunoassay, and chemiluminescence immunoassay.
  9. 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。The rapid detection structure according to claim 1, wherein the samples collected by the sampling structure include one or more of saliva, sputum, nasal cavity fluid, urine, blood, and excretion.
  10. 如权利要求7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：The fast detection structure according to claim 7, wherein the operation and use of the fast detection structure comprises the steps of:
    1)从快速检测结构上取下采样结构；1) Take off the sampling structure from the fast detection structure;
    2)将采样头伸入取样部位内，完成取样；2) Insert the sampling head into the sampling site to complete the sampling;
    3)将采样头经所述采样连接结构的管道状结构入口插入至管道状结构远端；3) inserting the sampling head into the distal end of the pipe-like structure through the inlet of the pipe-like structure of the sampling connection structure;
    4)静置快速检测结构，采样头所含有的液相经样本流出开口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、吸水纸垫，完成检测；4) Stand still for rapid detection structure, the liquid phase contained in the sampling head flows into the sample pad of the detection reagent strip through the sample outflow opening, and then flows through the binding pad, nitrocellulose membrane pad, and absorbent paper pad to complete the detection;
    5)从观察窗读取检测结果。5) Read the detection result from the observation window.
  11. 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。The application of the rapid detection structure in the development of rapid detection products as claimed in claim 1.
  12. 如权利要求1所述快速检测结构，其特征在于，一种柱推式采样检测一体化的快速检测结构，包括检测套筒、安装于检测套筒内部的检测试剂条、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，The rapid detection structure according to claim 1, characterized in that, a rapid detection structure integrating column push type sampling and detection, comprising a detection sleeve, a detection reagent strip installed inside the detection sleeve, and a detection reagent strip located at the end of the detection reagent strip. The sampling connection structure and the sampling structure that can form a detachable structure with the sampling connection structure,
    所述快速检测结构为柱状结构，所述采样头以柱状推进式向所述检测套筒内插入的操作方式完成检测，其中所述采样连接结构与所述检测套筒连接；The rapid detection structure is a columnar structure, and the sampling head is inserted into the detection sleeve in a columnar pushing manner to complete the detection, wherein the sampling connection structure is connected to the detection sleeve;
    2)所述检测试剂条以采样结构推进的方向依次设置有样品垫、标记物结合垫、硝酸纤维素膜垫和吸水纸垫；2) The detection reagent strip is sequentially provided with a sample pad, a marker binding pad, a nitrocellulose membrane pad and an absorbent paper pad in the direction in which the sampling structure advances;
    3)所述采样头可插入所述采样连接结构内，所述采样连接结构朝向所述检测试剂条的样品垫的位置开设有使待检液相流至所述样品垫的样本流出开口；3) The sampling head can be inserted into the sampling connection structure, and the sampling connection structure is provided with a sample outflow opening facing the sample pad of the detection reagent strip so that the liquid phase to be tested flows to the sample pad;
    4)所述采样结构为设置有采样头和采样手柄的插入式结构，其中采样头与采样手柄之间设置有防止待检液相返流的封堵结构；4) The sampling structure is a plug-in structure provided with a sampling head and a sampling handle, wherein a blocking structure is provided between the sampling head and the sampling handle to prevent backflow of the liquid phase to be tested;
    5)所述采样头插入至所述采样连接结构内，所述采样头插入所述采样连接结构的端部受到挤压，所述采样连接结构朝向采样头插入方向的位置设置有与所述封堵结构相匹配的防止液相返流的套筒结构。5) The sampling head is inserted into the sampling connection structure, the end of the sampling head inserted into the sampling connection structure is squeezed, and the position of the sampling connection structure facing the insertion direction of the sampling head is provided with the seal Sleeve structure matching the plugging structure to prevent liquid phase reflux.
PCT/CN2022/087798 2021-10-30 2022-04-20 Column push type sampling and detection integrated rapid detection structure and application thereof WO2023071084A1 (en)

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