CN113758915A - Novel lateral chromatography detection card - Google Patents

Novel lateral chromatography detection card Download PDF

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Publication number
CN113758915A
CN113758915A CN202110445225.8A CN202110445225A CN113758915A CN 113758915 A CN113758915 A CN 113758915A CN 202110445225 A CN202110445225 A CN 202110445225A CN 113758915 A CN113758915 A CN 113758915A
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micro
test paper
microfluidic
main body
pad
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傅善基
辛晓文
王有志
王鹏浩
李红江
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Weihai Neoprobio Co ltd
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Weihai Neoprobio Co ltd
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N21/78Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5027Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/10Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept

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  • Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
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  • Analytical Chemistry (AREA)
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  • Chemical Kinetics & Catalysis (AREA)
  • General Physics & Mathematics (AREA)
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  • Dispersion Chemistry (AREA)
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  • Clinical Laboratory Science (AREA)
  • Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)

Abstract

The invention relates to the technical field of manufacturing of lateral chromatography detection cards, in particular to a novel lateral chromatography detection card which can effectively improve the flow of a liquid sample to be detected from a sample pad to a combination pad and further improve the detection accuracy, and is characterized in that the sample pad in a test paper main body is connected with the combination pad in a flush manner, a micro-flow control mechanism or a micro-flow control structure is arranged at the position, corresponding to the adjacent position of the sample pad and the combination pad in the test paper main body, of an upper cover of a cutting sleeve, the micro-flow control mechanism comprises a micro-flow control main body, a comb-tooth-shaped micro-flow channel array is arranged on the micro-flow control main body, more than three micro-flow channels which are parallel to each other are arranged in the micro-flow channel array, the cross section of the micro-flow channel is in a reversed U shape with an opening at the lower end, and the micro-flow channels are arranged along the length direction of the test paper main body, and the detection precision and accuracy are obviously improved under the condition of not greatly improving the assembly complexity.

Description

Novel lateral chromatography detection card
The technical field is as follows:
the invention relates to the technical field of manufacturing of lateral chromatography detection cards, in particular to a novel lateral chromatography detection card which can effectively improve the flow of a liquid sample to be detected from a sample pad to a combination pad so as to improve the detection accuracy.
Background art:
the conventional structure of the existing lateral chromatography is shown in figure 5, and comprises 5 components of a bottom lining, a sample pad, a combined pad, a membrane and absorbent paper. Wherein the bottom lining is a rubber plate, the components of the sample pad, the combination pad, the film, the absorbent paper and the like are sequentially stuck on the bottom lining, and the connection among the components is generally 1mm-2 mm; wherein, the combination pad is coated with a detection antibody marked by nano particles (colloidal gold, fluorescent microspheres and quantum dot nano particles), and the nitrocellulose membrane is coated with a detection line (T line capture antibody) and a control line (C line capture antibody). During detection, a detected sample forms an antigen-detection antibody compound through a detection antibody under the capillary action, the compound continuously crawls, a double-antibody sandwich compound is formed through a detection line coated with a capture antibody, and a signal band is presented at the detection line. Excess detection antibody flows through the detection line, forming immune complexes on the subsequent control line, presenting a colored band.
As is known from the chromatographic structure, the absorbent pad and the conjugate pad are partially laminated with NC, and the sample pad covers a part of the conjugate pad. The layering, contact between layers needs to be intimate, uniform, without introducing physical distortion, contaminants, or chemical impurities at the surface of any of the layers, and many of the problems associated with liquid flow uniformity are associated with the layering of components.
The chromatography product is one of the most difficult factors to control in the manufacturing process, and various materials are perfectly and repeatedly assembled together. Any interface defects and interface non-repeatability existing between materials of each layer can directly cause the repeatability of detection results to be poor or even fail, and the problem can be amplified around the cut-off value. The existing three products of colloidal gold immunochromatography, fluorescence immunochromatography and up-conversion luminescence immunochromatography are established on a technology platform of chromatography, so that the immunochromatography technology still plays a great role, however, the inherent defects of the immunochromatography technology can not be ignored no matter from the basic principle or the manufacturing process, and the requirement of precise medical treatment on the detection precision is difficult to meet. To address these challenges, one of the development directions has been to seamlessly integrate several thin film materials, eliminating multiple distinct and difficult to control assembly processes.
The combination pad and the sample pad are both made of glass fiber membrane materials, and due to the influence of materials and a pad pretreatment process, compared with good 'laminating' connection between the combination pad and the NC membrane and between the NC membrane and the water absorption pad, the 'laminating' connection between the combination pad and the sample pad is relatively unsatisfactory, and the influence on lateral chromatography products is the largest.
The invention content is as follows:
aiming at the defects and shortcomings in the prior art, the invention provides a novel lateral chromatography detection card structure, and the reliability of a liquid channel at the joint of a combination pad and a sample pad can be effectively improved by correspondingly arranging a micro-fluidic mechanism or a micro-fluidic structure above the combination pad and the sample pad.
The invention is achieved by the following measures:
the utility model provides a novel side direction chromatography detects card, is equipped with cutting ferrule and test paper main part, and the cutting ferrule is by base and upper cover lock formation cavity, and the test paper main part is arranged in the cavity of cutting ferrule, the cutting ferrule is covered the sample pad position that corresponds the test paper main part and is seted up the application of sample hole on, a serial communication port, sample pad meets with combination pad parallel and level in the test paper main part, and the cutting ferrule upper cover corresponds sample pad and combination pad in the test paper main part and sets up miniflow control mechanism or microfluidic structure, microfluidic mechanism includes microfluidic main part, is equipped with broach form miniflow channel array in the microfluidic main part, be equipped with more than three miniflow channels that are parallel to each other in the miniflow channel array, miniflow channel cross-section is lower extreme open-ended and is the shape of intersecting, and miniflow channel sets up along test paper main part length direction.
The width range of the microfluidic main body is 2-5mm, the aperture width of a microfluidic channel on the lower side of the microfluidic main body is 0.3-1.0mm, the distance between adjacent microfluidic channels is 0.2-1.0mm, and the depth range of the microfluidic channel is 0.5-2.0 mm.
The upper side of the microfluidic main body is fixedly connected with the upper cover of the clamping sleeve, the upper cover of the clamping sleeve is buckled with the base and tightly pressed on the upper side of the test paper main body, and in order to ensure the assembly stability and the tight pressing of the microfluidic main body and the test paper main body, the upper cover of the clamping sleeve and the base can be internally provided with matched buckling mechanisms or supporting columns.
Compared with the prior art, the invention avoids the problem of poor liquid fluidity of detection caused by the lamination of the sample pad and the combined pad layer, and obviously improves the detection precision and accuracy under the condition of not greatly improving the assembly complexity.
Description of the drawings:
FIG. 1 is a schematic structural diagram of the present invention.
Fig. 2 is a partial structural view along the direction B-B in fig. 1.
Fig. 3 is a cross-sectional view of the microfluidic body of fig. 1 taken along the direction a-a.
Fig. 4 is an enlarged view of fig. 3.
FIG. 5 is a schematic diagram of the main structure of a conventional test strip.
FIG. 6 is a graph showing the comparison of the time when the conventional chromatography device and the sample of this patent flowed into the NC membrane in example 1 of the present invention.
Reference numerals: cutting ferrule 1, application of sample hole 2, sample pad 3, combination pad 4, micro-fluidic main part 5, micro-fluidic channel 6, upper cover 7.
The specific implementation mode is as follows:
the invention is further described below with reference to the accompanying drawings and examples.
As shown in the attached drawing, the invention provides a novel lateral chromatography detection card, which is provided with a card sleeve 1 and a test paper main body, wherein the card sleeve 1 is buckled by a base and an upper cover to form a cavity, the test paper main body is arranged in the cavity of the card sleeve, and a sample adding hole 2 is arranged at the position of a sample pad corresponding to the test paper main body on the upper cover of the card sleeve 1, and is characterized in that the sample pad 3 in the test paper main body is flush connected with a combination pad 4 (because the sample pad and the combination pad are both made of glass fiber materials, the sample pad and the combination pad can not be seamlessly connected under a non-laminated connection structure) and a micro-flow mechanism is arranged at the position, corresponding to the sample pad 3 and the combination pad 4, in the test paper main body of the card sleeve, and comprises a micro-flow control mechanism 5, a comb-shaped micro-flow channel array is arranged on the micro-flow channel 5, more than three parallel micro-flow channels 6 are arranged in the micro-flow channel array, the cross section is in an inverted U shape with an opening at the lower end, the microfluidic channel 6 is arranged along the length direction of the test paper main body.
The width range of the microfluidic main body 5 is 2-5mm, the aperture width of the microfluidic channel 6 on the lower side of the microfluidic main body is 0.3-1.0mm, the distance between adjacent microfluidic channels 6 is 0.2-1.0mm, and the depth range of the microfluidic channel 6 is 0.5-2.0 mm.
The upper side of the microfluidic main body 5 is fixedly connected with the upper cover of the clamping sleeve, the upper cover of the clamping sleeve is buckled with the base and tightly pressed on the upper side of the test paper main body, and in order to ensure the assembly stability and the tight pressing of the microfluidic main body and the test paper main body, the upper cover of the clamping sleeve and the base can be internally provided with matched buckling mechanisms or supporting columns.
Example 1:
the novel lateral flow assay card in this example: the test paper comprises a test paper main body, a sample pad 3, a combination pad 4, a micro-flow control mechanism and a clamping sleeve, wherein the sample pad 3 is connected with the combination pad 4 in a flush manner, the clamping sleeve upper cover is provided with the micro-flow control mechanism corresponding to the adjacent position of the sample pad 3 and the combination pad 4 in the test paper main body, the micro-flow control mechanism comprises a micro-flow control main body 5, a comb-tooth-shaped micro-flow channel array is arranged on the micro-flow control main body 5, more than three micro-flow channels which are parallel to each other are arranged in the micro-flow channel array, the cross section of each micro-flow channel is in an inverted U shape with an opening at the lower end, and the micro-flow channels are arranged along the length direction of the test paper main body; the width range of the microfluidic main body 5 is 2-5mm, the aperture width of a microfluidic channel on the lower side of the microfluidic main body is 0.4mm, the distance between adjacent microfluidic channels is 0.45mm, and the depth range of the microfluidic channel is 0.8 mm.
The precision of the application is verified by taking an NT-proBNP detection kit (conventional chromatographic structure) as a comparative example, and the main investigation indexes are as follows: the improvement in chromatographic performance over time, as seen after several experiments, is shown in the following table:
TABLE 1
Figure RE-GDA0003203060640000051
Figure RE-GDA0003203060640000061
It can be seen that the lateral chromatography detection card adopting the structure of the present application in this example has the following advantages: (1) the time for the sample to flow into the NC membrane is shorter, and the average time for flowing into the NC membrane is shortened to 9 seconds from 16.4 seconds; (2) the time control precision is higher, and CV17.39 percent is reduced to 8.85 percent.
Example 2:
this example further examined the differences in product precision between the present application (same structure as example 1) and the conventional chromatographic structures as shown in the following table:
TABLE 2
Figure RE-GDA0003203060640000071
TABLE 3
Figure RE-GDA0003203060640000072
Figure RE-GDA0003203060640000081
It can be seen that the time of sample chromatography has a great influence on the product performance, and the precision of T line, C line and T/C signal is obviously improved because the structure of the product of the application well controls the chromatography time, and the release rate and accuracy of fluorescence are not obviously influenced.

Claims (4)

1. The utility model provides a novel side direction chromatography detects card, is equipped with cutting ferrule and test paper main part, and the cutting ferrule is by base and upper cover lock formation cavity, and the test paper main part is arranged in the cavity of cutting ferrule, the cutting ferrule is covered the sample pad position that corresponds the test paper main part and is seted up the application of sample hole on, a serial communication port, sample pad meets with combination pad parallel and level in the test paper main part, and the cutting ferrule upper cover corresponds sample pad and combination pad in the test paper main part and adjoins the department and sets up miniflow control mechanism, miniflow control mechanism includes the miniflow control main part, is equipped with broach form miniflow channel array in the miniflow main part, be equipped with the more than three miniflow passageway that are parallel to each other in the miniflow passageway array, miniflow passageway cross-section is lower extreme open-ended hundredform, and miniflow passageway sets up along test paper main part length direction.
2. The novel lateral flow assay card of claim 1, wherein the width of the microfluidic body ranges from 2mm to 5mm, the aperture width of the microfluidic channel on the lower side of the microfluidic body ranges from 0.3 mm to 1.0mm, the distance between adjacent microfluidic channels ranges from 0.2 mm to 1.0mm, and the depth of the microfluidic channel ranges from 0.5 mm to 2.0 mm.
3. The novel lateral chromatography detection card as claimed in claim 1, wherein the upper side of the microfluidic main body is fixedly connected with the upper cover of the card sleeve, and is fastened with the base through the upper cover of the card sleeve and is tightly pressed on the upper side of the test paper main body, and in order to ensure the assembly stability and the tight press fit of the microfluidic main body and the test paper main body, the upper cover of the card sleeve and the base are provided with matched fastening mechanisms or supporting columns.
4. The novel lateral flow assay card of claim 2, wherein the aperture width of the microfluidic channel on the lower side of the microfluidic body is 0.4mm, the distance between adjacent microfluidic channels is 0.45mm, and the depth of the microfluidic channel is in the range of 0.8 mm.
CN202110445225.8A 2021-04-23 2021-04-23 Novel lateral chromatography detection card Pending CN113758915A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117129671A (en) * 2023-10-26 2023-11-28 苏州星安生物科技有限公司 Excrement sample collection and detection integrated device

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Publication number Priority date Publication date Assignee Title
CN201804007U (en) * 2010-08-13 2011-04-20 北京万泰生物药业股份有限公司 Multi-window multi-detection index detecting card
CN205384281U (en) * 2015-11-30 2016-07-13 江苏衡谱分析检测技术有限公司 A trapezoidal chromatography test paper strip for detecting multicomponent pesticide residue
CN205484358U (en) * 2016-01-20 2016-08-17 江苏衡谱分析检测技术有限公司 Combined two -way colloidal gold immunoassay chromatography test paper strip
CN106290814A (en) * 2015-05-21 2017-01-04 江苏衡谱分析检测技术有限公司 A kind of combined two-way colloidal gold immuno-chromatography test paper strip
US9921217B1 (en) * 2017-07-31 2018-03-20 Dnt Scientific Research, Llc Rapid diagnostic test device by driven flow technology
CN207851079U (en) * 2017-12-27 2018-09-11 江苏奥雅生物科技有限公司 A kind of immune micro-fluidic detection card of paper chip
CN111308069A (en) * 2020-03-09 2020-06-19 中国农业科学院烟草研究所 Time-resolved fluorescence immunochromatography test paper card for testing clothianidin
CN111965347A (en) * 2019-05-19 2020-11-20 王哲 Lateral chromatography detection device and kit based on fluid control
WO2021015273A1 (en) * 2019-07-23 2021-01-28 田中貴金属工業株式会社 Liquid sample inspection tool
JP2021018240A (en) * 2019-07-23 2021-02-15 田中貴金属工業株式会社 Liquid sample inspection tool

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN201804007U (en) * 2010-08-13 2011-04-20 北京万泰生物药业股份有限公司 Multi-window multi-detection index detecting card
CN106290814A (en) * 2015-05-21 2017-01-04 江苏衡谱分析检测技术有限公司 A kind of combined two-way colloidal gold immuno-chromatography test paper strip
CN205384281U (en) * 2015-11-30 2016-07-13 江苏衡谱分析检测技术有限公司 A trapezoidal chromatography test paper strip for detecting multicomponent pesticide residue
CN205484358U (en) * 2016-01-20 2016-08-17 江苏衡谱分析检测技术有限公司 Combined two -way colloidal gold immunoassay chromatography test paper strip
US9921217B1 (en) * 2017-07-31 2018-03-20 Dnt Scientific Research, Llc Rapid diagnostic test device by driven flow technology
CN207851079U (en) * 2017-12-27 2018-09-11 江苏奥雅生物科技有限公司 A kind of immune micro-fluidic detection card of paper chip
CN111965347A (en) * 2019-05-19 2020-11-20 王哲 Lateral chromatography detection device and kit based on fluid control
WO2021015273A1 (en) * 2019-07-23 2021-01-28 田中貴金属工業株式会社 Liquid sample inspection tool
JP2021018240A (en) * 2019-07-23 2021-02-15 田中貴金属工業株式会社 Liquid sample inspection tool
CN111308069A (en) * 2020-03-09 2020-06-19 中国农业科学院烟草研究所 Time-resolved fluorescence immunochromatography test paper card for testing clothianidin

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117129671A (en) * 2023-10-26 2023-11-28 苏州星安生物科技有限公司 Excrement sample collection and detection integrated device
CN117129671B (en) * 2023-10-26 2024-01-23 苏州星安生物科技有限公司 Excrement sample collection and detection integrated device

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