CN113740527A - Sampling and detection integrated rapid detection structure and application thereof - Google Patents
Sampling and detection integrated rapid detection structure and application thereof Download PDFInfo
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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
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- 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
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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
- G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
- G01N33/56983—Viruses
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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
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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
- G01N33/58—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
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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
- G01N33/58—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
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- 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
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- 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
Abstract
The invention discloses a sampling and detection integrated rapid detection structure, which comprises a detection card, a detection reagent strip positioned in the detection card, a sampling connection structure positioned at the starting end of the detection reagent strip and a sampling structure capable of forming a detachable structure with the sampling connection structure, wherein the sampling connection structure is a double-layer structure communicated with each other, and the sampling structure is provided with a sampling head and a handle-like insertion structure. The invention can be used for developing various rapid immunoassay products such as colloidal gold, fluorescence immunity, chemiluminescence and the like, improves the detection efficiency, convenience and accuracy of the immunoassay products, and has important clinical significance.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a sampling and detection integrated rapid detection structure and application thereof.
Background
The immunological detection technology is an experimental means for determining antigens, antibodies, immune cells, chemical components and the like by applying the immunological principle, and is widely applied to samples which are derived from human bodies and animal bodies and can be used for disease diagnosis and health detection and samples for environmental, pharmaceutical, food and industrial analysis. Commonly used are immunoturbidimetry, solid-phase enzyme immunoassay, chemiluminescence detection, immunofluorescence labeling, quantum dot immunoassay, colloidal gold immunoassay, spot immunoassay, etc. The development trend of clinical immunoassay technology products at present is high in sensitivity, rapidness, convenience, miniaturization, full quantification and automation, and is perfected through various technical innovations and technical improvements. Point-of-care testing (POCT) is one of the fastest-developing branches at present, chromatographic immunoassay is the most commonly used testing method, colloidal gold and fluorescence lateral flow chromatographic immunoassay technology products are most widely used, but the adopted methods are generally two or more steps, such as sampling, sample adding and observation, or sampling, dilution extraction, sample adding and observation, and the like, so that the development of a testing technology which is more convenient, rapid and high-performance and can improve anti-pollution protection is facilitated, the popularization and the use of clinical testing products are facilitated, the diagnosis and treatment quality is improved, and the method has important application value.
Disclosure of Invention
Compared with the prior art, the invention has the characteristics of convenience, rapidness, pollution prevention and the like, and improves the detection quality.
In view of the above, the present invention provides a sampling and detection integrated rapid detection structure, which includes a detection card, a detection reagent strip located in the detection card, a sampling connection structure located at the start end of the detection reagent strip, and a sampling structure capable of forming a detachable structure with the sampling connection structure; the sampling connection structure is a double-layer structure communicated with each other and comprises a reagent detection layer and a sample collection layer, wherein one part of the detection reagent strip is placed in the reagent detection layer, and the sample collection layer is provided with an insertion inlet of the sampling structure, a sample collection channel and a liquid phase flow channel communicated with the reagent detection layer; the sampling structure is a plug-in structure provided with a sampling head and a handle sample, and the handle sample structure is provided with a fixing structure for fixing a non-sampling end of the sampling head.
Furthermore, the sampling head is a detection sampling swab sample structure provided with a water-absorbent material structure. The water-absorbing material comprises flocking, sponge, polyester fiber, terylene, cotton, various artificial fibers and the like.
Furthermore, the sampling connection structure is a double-layer structure with a reagent detection layer below and a sample collection layer above, when the sampling connection structure is used, the sampling head is inserted into a sample collection channel of the sample collection layer for use, wherein the sectional area of the sample collection channel is smaller than that of the sampling head, and the sampling channel extrudes the sampling head in the insertion process.
Further, the liquid phase flow channel is an opening structure which is opened towards the insertion inlet of the sampling structure, so that the sample collection channel and the detection reagent strip in the reagent detection layer are communicated with each other.
Furthermore, the rapid detection structure comprises a detection assisting liquid phase which consists of a detection assisting solution and a container, wherein the detection assisting solution is a buffer salt solution containing casein.
Furthermore, the detection reagent strip is a structure of a sample pad, a marker combination pad, a nitrocellulose membrane pad and a water absorption paper pad which are sequentially stuck on the PVC bottom sheet and is placed in the detection card.
Furthermore, the integrated structure of the rapid detection structure sequentially comprises a base of the detection card, a detection reagent strip arranged on a detection reagent strip bracket on the base of the detection card and facing towards the insertion inlet of the sampling structure by one end of a sample pad, a sample collection channel communicated with the insertion inlet of the sampling structure, and a double-layer structure of a sampling connection structure communicated with a reagent detection layer from bottom to top, an upper cover of the detection card, a sampling structure which is positioned at the insertion inlet end and can be detachably connected with the sample collection channel and comprises a sampling head, a working structure which is positioned at the front end of the sampling structure and allows a liquid phase on the sampling head to flow into the detection reagent strip sample pad through a liquid phase flow channel to perform detection reaction by inserting the sampling head into the sample collection channel, and an observation window positioned on the detection card.
Further, the detection reagent strip is selected from at least one of a colloidal gold immunoassay, a fluorescence immunoassay, a quantum dot immunoassay, a dot immunoassay and a chemiluminescence immunoassay.
Further, the sample collected by the sampling structure comprises one or more of saliva, sputum, nasal fluid, urine, blood and secretion.
Further, the operation of the rapid detection structure comprises the following steps:
1) removing the sampling structure from the rapid detection structure;
2) the sampling head is extended into the sampling part to finish sampling;
3) inserting a sampling head into a sample acquisition channel through an insertion inlet of the sampling structure;
4) standing the rapid detection structure, allowing a liquid phase contained in the sampling head to flow into a sample pad of the detection reagent strip through a liquid phase flow channel, and then flowing through a combination pad, a nitrocellulose membrane pad and a water absorption paper pad to finish detection;
5) and reading the detection result from the detection window.
The rapid detection structure can be used for sampling and detecting samples from various sources, can directly sample and detect liquid samples such as saliva, blood, urine and the like, and can firstly soak the sampling head in the detection assisting solution and then sample or sample firstly, then place the sampling head in the detection assisting solution, extract and mix the samples and then detect non-liquid samples such as nasal cavities, oropharynx, skin, secretions and the like.
The rapid detection structure disclosed by the invention is applied to rapid detection product development.
Due to the adoption of the technical scheme, the invention has the following advantages:
1. the invention adopts a rapid detection structure integrating sampling and detection, and the sampling head is in direct contact with the detection reagent strip, thereby not only improving the convenience of the clinical sample from sampling to detection operation, but also effectively avoiding the interference of other factors on the sample detection and improving the detection quality. The background noise interference of the solid phase membrane is reduced, the detection sensitivity of the method is improved, and the high-sensitivity detection of the existing detection reagent is realized.
2. The sampling connection structure adopted by the invention is a double-layer structure with a reagent detection layer below and a sample collection layer above, a liquid phase flow channel between the double layers is positioned at one side of a sampling head insertion opening, the longitudinal sectional area of the sample collection channel is smaller than that of the sampling head, and the sample collection channel extrudes the sampling head for use in the insertion process of the sampling head, so that a detection liquid phase can quickly flow to a sample pad of a detection reagent strip and quickly pushes and presses forward to accelerate the release of a marker on the binding pad, the detection speed is accelerated, and the detection sensitivity is improved.
3. The invention adopts the detection test strip as a detection part, is suitable for various detection technologies which take lateral flow as main technical characteristics, such as colloidal gold, fluorescence immunity, quantum dots and the like, and expands the application range of the detection technology.
4. The invention is provided with the detection assisting liquid phase, not only can be used for samples with sufficient liquid phase, such as saliva, blood and the like, but also can be used for wetting the sampling head by the detection assisting liquid phase and then sampling, such as feces, sputum and the like, thereby improving the practicability of detection.
5. The method has simple operation steps, is easy to realize household use or self-operation, is convenient to use, reduces the waste of raw materials, obviously improves the working efficiency, and is applied to various fields of specialty and amateur detection.
Drawings
FIG. 1 is a schematic top view of the overall structure of the present invention;
FIG. 2 is a schematic longitudinal sectional view of the rapid detection structure according to the present invention;
FIG. 3 is a schematic diagram of a sampling structure of the present invention;
FIG. 4 is a schematic view of a sampling connection according to the present invention;
FIG. 5 is a longitudinal sectional view of the detachable structure of the present invention;
FIG. 6 is a schematic top view of the detachable structure of the present invention;
FIG. 7 is a schematic diagram of the detection-assisting liquid phase structure of the present invention.
The figures are labeled as follows:
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; a sampling connection structure 9; a liquid phase flow channel 10 of a double-layer structure; a sampling head fixing structure 11; a sampling structure insertion port 12; the sampling structure is inserted into the channel 13; a sampling structure interface 14; a detection assisting solution 15; and a detection assisting liquid container 16.
Detailed Description
To further illustrate the technical means and effects of the present invention for achieving the predetermined purpose, the following embodiments are further described with reference to the accompanying drawings, but the present invention is not limited to the following description.
As shown in fig. 1 and 2, the overall structure of the invention comprises a base 1, an upper cover 2, a sampling structure 3, an observation window 4 and a detection reagent strip 5; a sampling handle 6; a sampling head 7; a sample collection channel 8; a sampling connection structure 9; the liquid phase flow channel 10 with a double-layer structure is an integral structure, and sampling and detection are completed on the same structure.
As shown in fig. 3 and 7, the sampling structure of the present invention comprises a sampling handle 6; a sampling head 7; sampling head fixed knot constructs 11, wherein sampling head 7 is fixed in sampling handle 6 through sampling head fixed knot constructs 11 on, and sampling handle 6 is handed during the operation, places sampling head 7 in the sampling position and samples. If a saliva sample is to be taken, the sampling head 7 is placed in the mouth. If a blood sample is to be taken, the sampling head 7 is placed in the blood. If a urine sample is to be collected, the sampling head 7 is placed in the urine. The sampling head 7 can be wetted with the inspection assisting solution 15 and then sampled for detection, or the sampling head 7 can be immersed into the inspection assisting solution 15 for elution and mixing, and then the detection is carried out.
As shown in fig. 4, the sampling connection structure 9 of the present invention is a double-layer structure, and includes a detection reagent strip 5 and a sample collection channel 8; a liquid phase flow channel 10 of a double-layer structure; a sampling structure insertion port 12; the sampling structure is inserted into the channel 13; wherein the sample collection channel 8 is positioned at the upper layer, the detection reagent strip 5 is positioned at the lower layer, starting from the insertion port 12 of the sampling structure, the upper layer is inserted into the channel 13 from the sampling structure to the sample collection channel 8, and the lower layer is inserted into the detection reagent strip 5 through the liquid phase flow channel 10 of the double-layer structure.
As shown in fig. 5 and 6, the detachable 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; a sampling connection structure 9; a liquid phase flow channel 10 of a double-layer structure; a sampling head fixing structure 11; a sampling structure insertion port 12; the sampling structure is inserted into the channel 13; a sampling structure interface 14; wherein the base 1; an upper cover 2; an observation window 4; a detection reagent strip 5; a sample collection channel 8; a sampling connection structure 9; a liquid phase flow channel 10 of a double-layer structure; a sampling structure insertion port 12; the sampling structure is inserted into the channel 13; the sampling structure joint part 14 is a detection card part and a sampling handle 6; a sampling head 7; the sampling head fixing structure 11 is a sampling structure part.
Thus, in practical operation, when the rapid detection structure is a colloidal gold immunoassay structure, the detection reagent strip 5 is a test strip prepared by a colloidal gold method, and a sample pad, a colloidal gold binding pad coated with a colloidal gold marker, a nitrocellulose membrane pad coated with a non-labeled capture reagent and a water absorption paper pad are sequentially adhered on the PVC support plate; when the rapid detection structure is a fluorescence immunoassay structure, the detection reagent strip 5 is a test strip prepared by a fluorescence immunoassay method, and a sample pad, a fluorescent microsphere bonding pad coated with a fluorescent marker, a nitrocellulose membrane pad coated with a non-marker capture reagent and a water absorption paper pad are sequentially adhered on a PVC (polyvinyl chloride) support plate. During the use, take out the testing reagent card, take off sampling structure 3 from the reagent card, handheld sampling handle 6, sample with sampling head 7, then with sampling head 7 through sampling insertion hole 12, insert to sample collection channel 8 in through sampling insertion channel 13, sampling head 7 is extrudeed this moment, the liquid phase sample of collection flows to the sample pad of testing reagent strip 5 through bilayer structure's liquid phase flow channel 10, begins the testing reaction, then carries out the result and reads.
As shown in FIG. 7, the detection-assisting liquid phase 15 of the present invention comprises a detection-assisting solution 15 and a container 16 thereof, wherein the solution is a buffered saline solution containing casein.
Experimental study of the invention: the following experiment is illustrative of the detection method of the present invention and its effects, but is not intended to limit the present invention. The experimental methods used in the following experiments are all conventional methods unless otherwise specified. The materials, reagents and the like used are commercially available unless otherwise specified.
Experiment one: immune colloidal gold method new coronavirus antigen rapid detection experiment:
firstly, preparing a detection reagent strip:
preparing a detection reagent strip by adopting a conventional immune colloidal gold detection technology and a double-antibody sandwich method, and preparing a detection kit by adopting the rapid detection structure to perform a new coronavirus antigen detection experiment, wherein a colloidal gold label of a detection line T of the detection reagent strip indicates that an antibody is an anti-new coronavirus S protein monoclonal antibody of 10ug/ml, and colloidal gold particles with the particle size of 50nm are coated on a glass cellulose membrane colloidal gold conjugate pad; the capture antibody of the detection line T of the detection reagent strip is a 1.0mg/ml paired anti-new coronavirus S protein monoclonal antibody, and the capture antibody is coated on a nitrocellulose membrane; the capture antibody of the quality control line C of the detection reagent strip is a goat anti-mouse IgG polyclonal antibody of 1.0mg/ml, and the capture antibody is coated on a nitrocellulose membrane and used for capturing the colloidal gold labeled anti-new coronavirus S protein monoclonal antibody which is not captured specifically. And respectively sticking a water absorption paper membrane pad and a colloidal gold mark combined membrane pad at two ends of the nitrocellulose membrane printing membrane, and sticking a sample pad at one side of the combined membrane pad. And placing the adhered detection sheet on a strip cutting machine, and cutting into 3.5mm test strips.
Secondly, preparing a rapid detection structure:
the upper cover, the base and the sampling structure of the rapid detection structure are designed by Solidworks, a sample is printed in a 3D mode, a sponge sampling head is pasted on a sampling head fixing structure, and the sample is prepared for experimental detection.
Third, experimental method and result:
during the experiment, the prepared detection reagent strip and the rapid detection structure are assembled into a detection buckle, the assembled detection buckle is placed into an aluminum amber sealing bag with a drying agent, the sealing is carried out on a sealing machine, and a label is added. Preparing recombinant new coronavirus antigen S protein solutions with different concentrations by using healthy human saliva. And taking down the sampling structure from the detection buckle, soaking the sampling head with the prepared solution, then inserting the sampling head into the detection buckle through the insertion hole, standing for 20 minutes, observing the detection window, and reading a color development result on the test strip. The quality control line C of the test strip is colored, and the test line T is not colored and is negative; the quality control line C is colored, and the detection line T is also colored and is positive. As a result, positive reactions were observed at antigen S protein solution concentrations of 1.0, 0.1 and 0.05ng/ml, and negative reactions were observed at concentrations of 0.01ng/ml or less.
Experiment two: an immunofluorescence method for rapid detection of the new coronavirus antigen:
firstly, preparing a detection reagent strip:
preparing a detection reagent strip by adopting a conventional immunofluorescence detection technology double-antibody sandwich method, and preparing a detection kit by adopting the rapid detection structure to perform a new coronavirus antigen detection experiment, wherein fluorescent microspheres in a detection line T of the detection reagent strip mark an anti-new coronavirus S protein monoclonal antibody with an indication antibody of 20ug/ml, and the fluorescent microspheres with the particle size of 50 mu m are coated on a cellophane film colloidal gold combination pad; the capture antibody of the detection line T of the detection reagent strip is a 1.0mg/ml paired anti-new coronavirus S protein monoclonal antibody, and the capture antibody is coated on a nitrocellulose membrane; the capture antibody of the quality control line C of the detection reagent strip is a goat anti-mouse IgG polyclonal antibody of 1.0mg/ml, and the capture antibody is coated on a nitrocellulose membrane and used for capturing the fluorescent microsphere labeled anti-new coronavirus S protein monoclonal antibody which is not captured specifically. And respectively sticking a water absorption paper membrane pad and a fluorescent microsphere mark combined membrane pad at two ends of the nitrocellulose membrane printing membrane, and sticking a sample pad at one side of the combined membrane pad. And placing the adhered detection sheet on a strip cutting machine, and cutting into 3.5mm test strips.
Secondly, preparing a rapid detection structure:
prepared as in experiment one.
Thirdly, a fluorescence detector: a commercially available highlighter pen was used.
Fourthly, experimental method and result:
during the experiment, the prepared detection reagent strip and the rapid detection structure are assembled into a detection buckle, the assembled detection buckle is placed into an aluminum amber sealing bag with a drying agent, the sealing is carried out on a sealing machine, and a label is added. Preparing recombinant new coronavirus antigen S protein solutions with different concentrations by using healthy human saliva. And taking down the sampling structure from the detection buckle, soaking the sampling head with the prepared solution, then inserting the sampling head into the detection buckle through the insertion hole, standing for 20 minutes, placing the detection buckle into a fluorescence detector, starting detection, and reading a fluorescence test result on the test strip. The ratio of the fluorescence value of the detection line T on the detection test strip to the fluorescence value of the quality control line C is more than 0.02, and the detection test strip is positive; the ratio of the fluorescence value of the detection line T on the detection test strip to the fluorescence value of the quality control line C is less than or equal to 0.02, and the detection test strip is negative. As a result, the antigen S protein solution was found to be positive at concentrations of 1.0, 0.1, 0.05 and 0.01ng/ml, and negative at concentrations of 0.005ng/ml or less.
Claims (10)
1. A sampling and detection integrated rapid detection structure is characterized in that the integrated rapid detection structure comprises a detection card, a detection reagent strip positioned in the detection card, a sampling connection structure positioned at the starting end of the detection reagent strip and a sampling structure which can form a detachable structure with the sampling connection structure;
the sampling connection structure is a double-layer structure communicated with each other and comprises a reagent detection layer and a sample collection layer, wherein one part of the detection reagent strip is placed in the reagent detection layer, and the sample collection layer is provided with an insertion inlet of the sampling structure, a sample collection channel and a liquid phase flow channel communicated with the reagent detection layer;
the sampling structure is a plug-in structure provided with a sampling head and a handle sample, and the handle sample structure is provided with a fixing structure for fixing a non-sampling end of the sampling head.
2. The rapid detection structure according to claim 1, wherein the sampling head is a detection sampling swab-like structure provided with a water-absorbent material structure.
3. The rapid test structure of claim 1, wherein the sampling connection structure is a double-layer structure of a reagent test layer below and a sample collection layer above, and the sampling head is inserted into a sample collection channel of the sample collection layer for use, wherein the cross-sectional area of the sample collection channel is smaller than that of the sampling head, and the sample collection channel presses against the sampling head during insertion.
4. The rapid detection structure of claim 1, wherein the liquid phase flow channel is open towards the insertion inlet of the sampling structure, thereby forming an open structure for communicating the sample collection channel with the test reagent strip in the reagent detection layer.
5. The rapid test structure according to claim 1, wherein the rapid test structure comprises a test-assisting liquid phase consisting of a test-assisting solution and a container, and the test-assisting solution is a buffered saline solution containing casein.
6. The rapid test structure of claim 1, wherein the integrated structure of the rapid test structure comprises, from bottom to top, a double-layer structure of a base of the test card, a test reagent strip disposed on a test reagent strip support slot on the base of the test card and having one end of a sample pad facing an insertion inlet of the sampling structure, a sample collection channel communicated with the insertion inlet of the sampling structure, and a sampling connection structure communicated with the reagent detection layer, an upper cover of the test card, a sampling structure having a sampling head and located at the insertion inlet end and detachably connected with the sample collection channel, a working structure having a sampling head inserted into the sample collection channel and allowing a liquid phase on the sampling head to flow into the test reagent strip sample pad through a liquid phase flow channel for performing a test reaction, and an observation window located on the test card.
7. The rapid test structure of claim 1, wherein the test strip is at least one of a colloidal gold immunoassay, a fluorescence immunoassay, a quantum dot immunoassay, a dot immunoassay, and a chemiluminescent immunoassay.
8. The rapid test structure of claim 1, wherein the sample collected by the sampling structure comprises one or more of saliva, sputum, nasal fluid, urine, blood, and secretion.
9. The rapid detection architecture of claim 1, wherein the operational use of the rapid detection architecture comprises the steps of:
1) removing the sampling structure from the rapid detection structure;
2) the sampling head is extended into the sampling part to finish sampling;
3) inserting a sampling head into a sample acquisition channel through an insertion inlet of the sampling structure;
4) standing the rapid detection structure, allowing a liquid phase contained in the sampling head to flow into a sample pad of the detection reagent strip through a liquid phase flow channel, and then flowing through a combination pad, a nitrocellulose membrane pad and a water absorption paper pad to finish detection;
5) and reading the detection result from the detection window.
10. Use of the rapid test structure of claim 1 in rapid test product development.
Priority Applications (3)
| Application Number | Priority Date | Filing Date | Title |
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| CN202111046449.8A CN113740527A (en) | 2021-09-08 | 2021-09-08 | Sampling and detection integrated rapid detection structure and application thereof |
| JP2022539421A JP2023544922A (en) | 2021-09-08 | 2022-04-20 | Rapid detection structure with integrated sampling and detection and its use |
| PCT/CN2022/087797 WO2023035617A1 (en) | 2021-09-08 | 2022-04-20 | Fast testing structure integrating sampling and testing and application thereof |
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| CN202111046449.8A CN113740527A (en) | 2021-09-08 | 2021-09-08 | Sampling and detection integrated rapid detection structure and application thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2023035617A1 (en) * | 2021-09-08 | 2023-03-16 | 嘉兴康源科泰科技发展有限公司 | Fast testing structure integrating sampling and testing and application thereof |
| WO2023147713A1 (en) * | 2022-02-07 | 2023-08-10 | 嘉兴康源科泰科技发展有限公司 | Combined detection structure for dual sampling and integrated detection and use thereof |
| WO2023155291A1 (en) * | 2022-02-18 | 2023-08-24 | 嘉兴康源科泰科技发展有限公司 | Test technique based on combined loading of saliva and nasal samples, and use thereof |
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| US20040184954A1 (en) * | 2003-03-18 | 2004-09-23 | Huiyan Guo | Lateral flow immunoassay devices for testing saliva and other liquid samples and methods of use of same |
| GB2483077A (en) * | 2010-08-25 | 2012-02-29 | Concateno Uk Ltd | Sample testing assay apparatus and method |
| CN103217313B (en) * | 2013-03-25 | 2015-10-14 | 万华普曼生物工程有限公司 | A kind of feces collection pick-up unit and the method based on this device detection ight soil |
| FR3045158A1 (en) * | 2015-12-15 | 2017-06-16 | Imaccess | LATERAL FLOW IMMUNOCHROMATOGRAPHIC TEST DEVICE WITHOUT HOOK EFFECT |
| CN105784443B (en) * | 2016-03-16 | 2018-12-07 | 杭州安旭科技有限公司 | A kind of sample testing apparatus and sample collection detection device and method |
| CN106018394B (en) * | 2016-05-23 | 2018-11-23 | 江山海维科技有限公司 | Detection blocks the sample testing apparatus of not moisture-sensitive |
| EP3845900A4 (en) * | 2018-08-29 | 2021-10-27 | FUJIFILM Corporation | Chromatography kit, and chromatography method |
| CN111983211A (en) * | 2019-07-31 | 2020-11-24 | 帕米尔生物技术有限公司 | Detection device and reception device |
| CN111707810A (en) * | 2020-05-11 | 2020-09-25 | 杭州博拓生物科技股份有限公司 | Sample detection device and application method thereof |
| CN216117640U (en) * | 2021-09-08 | 2022-03-22 | 嘉兴康源科泰科技发展有限公司 | Sampling and detection integrated rapid detection structure |
| CN113740527A (en) * | 2021-09-08 | 2021-12-03 | 嘉兴康源科泰科技发展有限公司 | Sampling and detection integrated rapid detection structure and application thereof |
-
2021
- 2021-09-08 CN CN202111046449.8A patent/CN113740527A/en active Pending
-
2022
- 2022-04-20 WO PCT/CN2022/087797 patent/WO2023035617A1/en unknown
- 2022-04-20 JP JP2022539421A patent/JP2023544922A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2023035617A1 (en) * | 2021-09-08 | 2023-03-16 | 嘉兴康源科泰科技发展有限公司 | Fast testing structure integrating sampling and testing and application thereof |
| WO2023147713A1 (en) * | 2022-02-07 | 2023-08-10 | 嘉兴康源科泰科技发展有限公司 | Combined detection structure for dual sampling and integrated detection and use thereof |
| WO2023155291A1 (en) * | 2022-02-18 | 2023-08-24 | 嘉兴康源科泰科技发展有限公司 | Test technique based on combined loading of saliva and nasal samples, and use thereof |
Also Published As
| Publication number | Publication date |
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| JP2023544922A (en) | 2023-10-26 |
| WO2023035617A1 (en) | 2023-03-16 |
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