WO2009119993A2 - Trousse d'immunochromatographie et procédé de fabrication - Google Patents

Trousse d'immunochromatographie et procédé de fabrication Download PDF

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Publication number
WO2009119993A2
WO2009119993A2 PCT/KR2009/001408 KR2009001408W WO2009119993A2 WO 2009119993 A2 WO2009119993 A2 WO 2009119993A2 KR 2009001408 W KR2009001408 W KR 2009001408W WO 2009119993 A2 WO2009119993 A2 WO 2009119993A2
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WO
WIPO (PCT)
Prior art keywords
immunochromatography
pad
strip
sample
kit
Prior art date
Application number
PCT/KR2009/001408
Other languages
English (en)
Korean (ko)
Other versions
WO2009119993A3 (fr
Inventor
박재구
이도부
Original Assignee
(주)래피젠
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Priority claimed from KR1020090017090A external-priority patent/KR20090101823A/ko
Application filed by (주)래피젠 filed Critical (주)래피젠
Publication of WO2009119993A2 publication Critical patent/WO2009119993A2/fr
Publication of WO2009119993A3 publication Critical patent/WO2009119993A3/fr

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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
    • 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
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G01N33/54386—Analytical elements
    • G01N33/54387—Immunochromatographic test strips
    • G01N33/54388—Immunochromatographic test strips based on lateral flow
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/90—Plate chromatography, e.g. thin layer or paper chromatography
    • G01N30/92—Construction of the plate

Definitions

  • the present invention relates to an immunochromatography kit having a built-in immunochromatography strip for use in immunoassay and a method for producing the same, and more particularly, to an immunochromatography kit and a method for producing the same, which are advantageous for production automation and cost reduction.
  • immunochromatography is a method that allows the qualitative and quantitative testing of analytes in a short time by utilizing the properties of biological or chemical substances specifically attaching to each other.
  • an immunochromatography kit in the form of mounting such an immunochromatography strip inside a plastic housing is generally used.
  • an immunochromatography strip a container containing a sample is required separately, but the immunochromatography kit embedded in the housing is easy to use because it does not need a separate experimental container by directly injecting the sample into the inlet prepared in the housing.
  • hepatitis C Through analysis using such an immunochromatography strip or an immunochromatography kit comprising the same, hepatitis C, using samples such as whole blood, plasma, serum, tears, saliva, urine, runny nose, and body fluids of humans or animals, Hepatitis B, influenza virus, avian influenza virus, rotavirus, AIDS, syphilis, chlamydia, malaria, typhoid, gastric ulcer, tuberculosis, SARS, dengue, leprosy and other pathogens and antibodies can be examined.
  • samples such as whole blood, plasma, serum, tears, saliva, urine, runny nose, and body fluids of humans or animals
  • Hepatitis B influenza virus, avian influenza virus, rotavirus, AIDS, syphilis, chlamydia, malaria, typhoid, gastric ulcer, tuberculosis, SARS, dengue, leprosy and other pathogens and antibodies can be examined.
  • they can be used to confirm the presence of pregnancy, ovulation, cancer markers, heart disease indicators, etc., and can be used to confirm the administration of drugs such as cannabis methamphetamine, hiropon, opium, amphetamines, morphine, cocaine, etc. And furthermore can be used to identify bioterrorism by detection of lysine, anthrax, burcellella, botulinum, bexonia, salmonella, cholera, Staphylococcal enterotoxin B, tullaemia, etc. It can be used for rapid testing and diagnosis in various fields, such as those that can be used to identify food poisoning bacteria such as E. coli and Yexinia.
  • FIG. 1 is a cross-sectional view showing a representative example of an immunochromatography strip according to the prior art
  • Figure 2 is an exploded perspective view showing a representative example of an immunochromatography kit according to the prior art
  • Figure 3 is an immunochromatography of Figure 2 A perspective view illustrating the packaging method of the kit.
  • a typical immunochromatography strip 10 used for immunochromatographic analysis is an elongated rectangular support 11 made of an adhesive plastic material, and from one side to the other on the support. It comprises a sample pad 21, a conjugate pad 22, a signal detection pad 23 and an absorption pad 24, which are disposed substantially sequentially.
  • the sample pad 21 absorbs the liquid sample (or analyte) to be analyzed and ensures a uniform flow of the liquid sample.
  • the signal detection pad 23 disposed at a position next to the specimen pad 21 and the conjugate pad 22 is usually a detection zone 23a and a control zone which are spaced apart from each other by a certain distance. zone) 23b.
  • the detection area 23a is an area for checking whether an analyte is present in the liquid sample
  • the control area 23b is an area for checking whether the liquid sample has normally passed through the detection area 23a.
  • the absorption pad 24 is disposed at a position next to the signal detection pad 23, that is, at a position adjacent to the other end of the support 11. The absorbent pad 24 absorbs the liquid sample passing through the signal detection pad 23 and assists in capillary flow of the liquid sample on the immunochromatography strip 1.
  • the immunochromatography strip 10 is attached on the support 11 in the order of the sample pad 21, the conjugate pad 22, the signal detection pad 23, and the absorption pad 24.
  • the sample pad 22 is moved to the absorption pad 24 via the signal detection pad 23, and an immunoassay is performed through signal detection at the signal detection pad 23.
  • modified immunochromatographic strips incorporate a conjugate and a signal detector in one porous pad.
  • the sample pad, the conjugate pad, the signal detection pad, and the absorption pad may be arranged to overlap each other or to be arranged on a plastic support at regular intervals. In the latter case, the liquid sample is transferred to the sample pad, the conjugate pad, and the signal detection pad by capillary action using another medium.
  • the immunochromatography strip 10 as described above can be used independently for immunochromatography analysis, but for a more convenient and accurate analysis, the immunochromatography kit 10 is mounted in a plastic housing. It may be used for immunochromatographic analysis in the state of (1).
  • the immunochromatography kit 1 has an immunochromatography strip 10, a lower housing 40 containing the immunochromatography strip 10, and a lower housing. And an upper housing 50 that complementarily engages with 40.
  • the upper housing 50 is an inlet 51 for liquid sample input for penetrating and formed at a position corresponding to the sample pad 21 of the embedded immunochromatography strip 10, and the embedded immunochromatography strip 10.
  • a confirmation window 53 for confirming the signal detection result, which is formed to penetrate elongated at a position corresponding to the signal detection pad 23 of the reference numeral).
  • the filtrate is absorbed by the absorption pad 24. Are absorbed in.
  • the absorbent pad 24 does not have sufficient absorbent capacity, the liquid sample or conjugate absorbed by the absorbent pad 24 flows back to the signal detecting pad 23. This tendency is further strengthened by drying of the signal detection pad 23 over time.
  • the liquid sample or conjugate absorbed by the absorbent pad 24 flows back to the signal detecting pad 23, the liquid sample or conjugate is reattached to the control area 23b or the detection area 23a of the signal detecting pad 23, and thus the test result. It may be difficult to keep clean, and sometimes it may react unspecifically with the signal detecting material in the detection area 23a, causing false test results.
  • the absorbent force of the absorbent pad 24 has a deep correlation with the background clearance.
  • the immunochromatography strip 10 is sensitive to moisture. In particular, water inactivation of the signal detection material present in the conjugate pad 22 and the detection area 23a immediately leads to an incorrect test result. This is a fatal weakness of the immunochromatography strip 10.
  • the assembly of the immunochromatography strip 10 takes place in a space of 20% or less relative humidity, but in order to minimize the influence of moisture, the immunochromatography strip 10 is usually packaged together with an absorbent bag.
  • the conventional immunochromatography kit 1 is usually stored in the pouch 3 together with the absorbent bag 2 and sold.
  • the process of packaging together with the absorbent bag 2 becomes a factor of reducing the packaging efficiency.
  • the absorbent bag 2 is usually filled with silica gel.
  • silica gel has a slow absorption rate and relatively low absorption rate, so that an absorbent with improved absorbency is required to effectively remove humidity included in the work.
  • the absorbent composed of silica gel absorbs 8-15% of moisture in a relative humidity of 20%, has a very slow rate of absorbing moisture, and furthermore is harmful to the environment in the silica gel manufacturing process. It is a situation that there is a problem such as a large cost to waste water treatment by discharging.
  • FIG. 4 is a cross-sectional view showing an improved example of an immunochromatography strip according to the prior art
  • FIG. 5 is an exploded perspective view showing an improved example of an immunochromatography kit according to the prior art
  • FIG. I is a perspective view illustrating a method for packaging an immunochromatography kit.
  • an immunochromatography strip as disclosed in "Immunochromatography Strips and Kits Comprising" of Korean Patent Registration No. 10-0735080, filed and patented by the applicant of the present invention And immunochromatography kits have been provided.
  • the immunochromatography strip 10 ′ like the normal immunochromatography strip 10 as shown in FIG. 1, is an elongated rectangular support 11 made of an adhesive plastic material. ') And a sample pad 21', a conjugate pad 22 ', a signal detection pad 23', and an absorption pad 30, which are arranged substantially sequentially from one side to the other side on the support. .
  • the absorbent pad 30 has a structure including a porous support 31 and an absorbent 32 which is dispersed in the pores of the porous support 31 or adsorbed or coated on the fiber yarn of the porous support 31. It has distinctive features. Furthermore, the absorbent pad 30 is characterized by further comprising a porous film layer 33 made of a porous membrane attached to the upper surface of the porous support 31.
  • the improved immunochromatography kit 1 ′ like the conventional immunochromatography kit 1 as shown in FIG. 2, is provided with an immunochromatography strip 10 ′, And a lower housing 40 for receiving the immunochromatography strip 10 'and an upper housing 50' that complementarily engages with the lower housing 40.
  • the upper housing 50 ' is an inlet 51' for liquid sample introduction, which is formed to penetrate at a position corresponding to the sample pad 21 'of the embedded immunochromatography strip 10', and the embedded immunochromatography. It is similar to the one provided with a confirmation window 53 'for signal detection result confirming purposes, which is formed to penetrate in an elongated position corresponding to the signal detection pad 23' of the graphics strip 10 ', but with immunity embedded therein. It has a distinguishing feature as further comprising a vent 55 at a position corresponding to the absorbent pad 30 of the chromatography strip 10 '.
  • the vent 55 so that the moisture contained in the packaging material is more easily absorbed through the absorbent 32 included in the absorbent pad 30 before applying to the immunochromatography analysis, immunochromatography After application to the analysis, the liquid sample absorbed in the absorbent pad 30 is more smoothly evaporated.
  • the absorbent 32 of the absorbent pad 30 strongly absorbs the liquid sample so that the liquid sample is the signal detection pad.
  • the absorbent pad 30 including the absorber 32 efficiently absorbs the liquid sample after the signal detection reaction is completed, promotes chromatographic flow, and prevents the occurrence of an inspection error due to the reverse flow of the liquid sample. In addition to promoting clearance, the preservation of signal detection results is also promoted.
  • the immunochromatography strip 10 ′ and the kit 1 including the same by the enhanced absorption ability by the absorbent 32 dispersed or adsorbed or coated on the porous support 31 constituting the absorbent pad 30 are included. As shown in FIG. 6, since the moisture in the air can be sufficiently absorbed, it is not necessary to pack the pouch 3 together with a separate absorbent bag. This not only simplifies packaging and doubles the speed of automatic packaging, but also provides powerful water absorption capabilities to more effectively protect the performance of an immunochromatography strip or immunochromatography strip kit from moisture inevitably contained in the manufacturing process. To make it possible.
  • the immunochromatography kit incorporating an immunochromatography strip still needs a lot of improvement in relation to its manufacturing process.
  • the lower housing 40 and the upper housing 50 'constituting the immunochromatography kit 1' are manufactured in an appropriate shape through a molding process using a mold, and after completion of the molding process, the immunochromatography is completed.
  • the grading strip 10 ' is placed one by one at a suitable position of the lower housing 40, and then the assembly process is performed such that the lower housing 40 is individually covered with the upper housing 50'.
  • the upper and lower housings In order to automate this manufacturing process, the upper and lower housings must be aligned in a certain direction, the immunochromatography strips must be correctly mounted on the lower housing, and the complementary upper and lower housings are covered by applying a pressure to the realigned upper housing. It is fixed by the uneven structure.
  • Such complex automation processes may include frequent malfunctions of the machine due to a machine error and a size deviation of the housing, and include a process that cannot be automated in detail.
  • the kit made of the upper and lower housings can not prevent the invasion of moisture, so the individual packaging process in the aluminum bag with a desiccant is essential.
  • the manufacturing method of the manufacturing process is highly dependent on labor due to the high proportion of the process to be dependent on manual labor.
  • a problem that is not suitable for mass production is still not suitable for mass production, given that hundreds of millions of immunochromatography strips or immunochromatography kits are consumed annually worldwide and are distributed at relatively low prices. Improvement is not an urgent problem and will not be possible.
  • the present invention has been created to solve the problems of the prior art as described above, the object of the present invention is to provide a new type of technology for moisture protection, suitable for the automation of the production process is suitable for mass production through automation
  • the present invention provides an immunochromatography kit that is advantageous in cost reduction.
  • An immunochromatography kit for achieving the above object, an elongated rectangular support made of an adhesive plastic material, a sample pad and a conjugate pad, a support disposed on one side of the support
  • an immunochromatography strip accommodating space comprising a signal detecting pad accommodating portion between the sample pad accommodating portion and the absorbent pad accommodating portion formed to receive the signal detecting pad portion.
  • An inlet is formed through the sample pad receiving portion to be positioned above the sample pad, the inlet is formed in a funnel shape to guide the liquid sample to be injected for analysis to the sample pad, and the liquid sample is smoothly through the inlet.
  • One or more vents are formed to penetrate so as to flow around the sample pads,
  • the width of the signal detection pad accommodating portion is formed to be wider than the width of the immunochromatography strip so that a clearance is formed at both sides of the signal detection pad portion.
  • the immunochromatography strip is attached to the bottom of the portion overlapping the signal detection pad of the support, at least two comprising at two positions corresponding to both ends of the signal detection pad.
  • the plastic film is Cellophane , Acetyle cellolose, Polyethylene (PE), Polypropylene (pp), Ethylene vinyl acetate, Polyvinyl chloride (PVC), Polyvinyliolene chloride (PVDC), Polystyrene (PS), Polycarbonate (PC), Polyamide (PA), Nylon, Polyestor (PET) , p olyvinyl alcohol ( PVAC ), Or from a material such as Among them, two or more films are laminated to be selected as a material having enhanced moisture resistance and heat sealability.
  • Another desirable feature of the present invention is that the plastic film is not transparent or the color is not easy to see the result of the deep detection pad in the window window through hole is added and sealed.
  • the selected moisture barrier and base are selected from PET, PP, PE and aluminum films or two or more of them deposited.
  • the attachment of the selected moisture protection plate and the bottom plate is selected from adhesives, hot melt and heat fusion methods or two or more of them are mixed.
  • a cover plate made of plastic material is prepared by using a mold having a plurality of strip receiving space moldings having a shape corresponding to the shape of the immunochromatography strip receiving space.
  • a cover molding process of forming a cover disc which can be separated into a plurality of covers by molding by pneumatic adsorption in a state of applying heat;
  • the immunochromatography kit and the method for producing the immunochromatography kit according to the present invention provide a new type of moisture preservation method and automate all processes with a simplified individual process, thus making an automated production process that is significantly less dependent on manual labor. Can be produced in large quantities in less time, thereby enabling a significant productivity improvement.
  • the amount of raw materials used can be reduced, thereby reducing the dependence on labor force, enabling significant cost reduction, and responding to large orders in a short time.
  • the product can be used without the inconvenience of opening the pouch packaging at the user's entrance, and the kit is disposable, so that it uses various materials to save production energy and minimize environmental pollution.
  • FIG. 1 is a cross-sectional view showing a representative example of an immunochromatography strip according to the prior art
  • Figure 2 is an exploded perspective view showing a representative example of an immunochromatography kit according to the prior art
  • FIG. 3 is a perspective view illustrating a packaging method of the immunochromatography kit of FIG.
  • FIG. 4 is a cross-sectional view showing an improved example of an immunochromatography strip according to the prior art
  • FIG. 5 is an exploded perspective view showing an improved example of an immunochromatography kit according to the prior art
  • FIG. 6 is a perspective view illustrating a packaging method of the immunochromatography kit of FIG.
  • FIG. 7 is a perspective view showing one embodiment of an immunochromatography kit according to the present invention.
  • FIG. 8 is an exploded perspective view illustrating the immunochromatography kit of FIG. 7;
  • FIG. 9 is a cross-sectional view showing the immunochromatography kit of FIG.
  • FIG. 10 is a plan view of the immunochromatography kit of FIG. 7,
  • FIG. 11 is a perspective view illustrating one embodiment of a method for preparing an immunochromatography kit according to the present invention.
  • FIG. 14 is a cross-sectional view of the immunochromatography kit of FIG. 12.
  • absorption pad 123 signal detection pad
  • bypass flow blocking partition member 200 cover
  • cover disc 210 sample pad receiver
  • vent window 230 signal detection pad receiving portion
  • bottom plate 300 ' bottom plate member
  • FIG. 7 is a perspective view showing an embodiment of an immunochromatography kit according to the invention
  • Figure 8 is an exploded perspective view showing the immunochromatography kit of Figure 7
  • Figure 9 is an immunochromatography kit of Figure 7 10 is a cross-sectional view illustrating the immunochromatography kit of FIG. 7.
  • the immunochromatography kit according to the present invention is adapted to be suitable for mass production using an automated production system and to reduce cost through material cost reduction, as shown in FIGS. And a cover 200 having an immunochromatography strip accommodating space for accommodating the immunochromatography strip 100, and a base plate 300 attached to the bottom side of the cover 200. Is done.
  • the immunochromatography strip 100 is formed of an elongated rectangular support 111 made of an adhesive plastic material and a support 111 similar to the immunochromatography strips of the prior art as shown in FIGS. 1 and 4.
  • the sample pad 121 and the conjugate pad 122 disposed on one side of the upper portion, the absorption pad 124 disposed on the other side of the upper portion of the support 111, and the signal detection disposed on the center portion of the upper portion of the support 111.
  • Pad 123 is formed of an elongated rectangular support 111 made of an adhesive plastic material and a support 111 similar to the immunochromatography strips of the prior art as shown in FIGS. 1 and 4.
  • the sample pad 121 and the conjugate pad 122 disposed on one side of the upper portion, the absorption pad 124 disposed on the other side of the upper portion of the support 111, and the signal detection disposed on the center portion of the upper portion of the support 111.
  • Pad 123 is formed of an elongated rectangular support 111 made of an adhesive plastic material
  • the cover 200 is formed to have an immunochromatography strip receiving space for receiving the immunochromatography strip 100, Cellophane , Acetyle cellolose, Polyethylene ( PE ), Polypropylene ( pp ), Ethylene vinyl acetate , Polyvinyl chloride (PVC), Polyvinyliolene chloride (PVDC), Polystyrene (PS), Polycarbonate (PC), Polyamide (PA), Nylon, Polyestor (PET), p such as olyvinyl alcohol (PVAC) It may be made of a plastic film and may be used as a material in which two or more of these films are laminated to increase moisture resistance and heat sealability.
  • the cover 200 Made of a transparent thermoplastic resin-based plastic material such as PET, as described in detail below, it becomes possible to form the cover 200 through a pneumatic adsorption-type molding process using a mold in the state of applying heat, the cover Even if the 200 does not have a separate confirmation window (see reference numeral 53 ′ in FIG. 5), the signal detection pad 123 may be visually observed to confirm the analysis result.
  • the window window can be molded into the signal detection pad accommodating part such as an injection hole or a vent by a punching process.
  • the immunochromatography kit according to the present invention may be configured to increase the visibility by forming a window (w) in the signal detection pad receiving portion 230, moisture It may be configured to be sealed by the protective film (c). At this time, the protective film (c) may be peeled off as shown in FIG. 13 during use.
  • Reference numeral 211 denotes a through hole formed at one side of the inlet 215 provided in the sample pad receiving unit 210.
  • the window window (w) in the present invention is required depending on the material of the receiving space of the strip, but is inevitably sealed during storage of the immunoassay kit to prevent the moisture barrier (c) to protect the analyte formed in the strip (c) ); It is a film laminated with PE film, aluminum film, PP film, etc. by applying heat to the cover and removing the film when using it. Packaging can be advantageous for automation and less process than moisture protection.
  • Hot melt is basically composed of polymer, adhesive resin, wax, antioxidant, etc., and it can be composed of various components depending on the material and strength of adhesive.
  • an adhesive may be applied to a single layer film or a laminated film to enable sealing without applying heat.
  • the immunochromatography strip accommodating space provided in the cover 200 may be formed to accommodate the sample pad 121 and the conjugate pad 122 of the immunochromatography strip 100.
  • a sample pad accommodating portion formed to accommodate the sample pad accommodating portion 210 of the sample, an absorbent pad accommodating portion 220 on the other side formed to accommodate the portion of the absorbent pad 124, and a portion of the signal detection pad 123.
  • a signal detection pad receiver 230 between the unit 210 and the absorbent pad receiver 220.
  • the immunochromatography strip receiving space includes a length, a width, and a sample pad 121 constituting the immunochromatography strip 100, a suction pad 124, and a signal detection pad of the immunochromatography strip 100 to be accommodated. It is formed in a size and shape in consideration of the thickness of each portion where the 123 is disposed. That is, the sample pad receiver 210 and the absorbent pad receiver 220 have a width w in consideration of the width of the immunochromatography strip 100, and the sample pad 121 and the absorbent pad 124. Considering that the thickness of the part is thick, it is formed with a relatively deeper depth. In addition, the signal detection pad accommodating part 230 is formed with a relatively smaller depth in consideration of the thinness of the portion of the signal detection pad 123.
  • the signal detection pad receiver 230 may be formed to have a width w corresponding to the width of the immunochromatography strip 100 similarly to the sample pad receiver 210 and the absorbent pad receiver 220. 7, 8 and 10, the cover having a width (W) wider than the width of the immunochromatography strip 100, so that the free space is formed on both sides of the portion of the signal detection pad 123. It is preferable to form If the immunochromatography strip and the cover are closely attached to each other, the liquid sample does not only move through the signal detection pad of the immunochromatography strip by capillary action, but rather the signal along the wall surface of the cover, in part by surface tension. The phenomenon that the detection pad is bypassed and moved may occur.
  • the cover 200 is formed to penetrate through the sample pad accommodating portion 210 and is positioned on the sample pad 121 when the immunochromatography kit is completed.
  • the liquid sample to be injected for analysis is a sample pad ( It is provided with an inlet 215 formed in the shape of the funnel so as to guide 121. And at least one vent 225 formed through the absorbent pad receiver 220 to be positioned above the absorbent pad 124.
  • vents 225 are provided, but the number is not limited.
  • the sample pad receiving portion 210 is formed deeper than the absorbent pad receiving portion 220 as the peripheral portion of the inlet 215 is formed in a funnel shape.
  • the present invention may not necessarily form the vent 225 selectively.
  • the base plate 300 is attached to the bottom side of the cover 200 to close the immunochromatography strip receiving space.
  • the base plate 300 as the cover, Cellophane , Acetyle cellolose, Polyethylene (PE), Polypropylene (pp), Ethylene vinyl acetate, Polyvinyl chloride (PVC), Polyvinyliolene chloride (PVDC), Polystyrene (PS), Polycarbonate (PC) , Polyamide (PA), Nylon, Polyestor (PET), p- Olyvinyl alcohol (PVAC), etc. can be composed of two or more of these films are laminated to make the material with increased moisture resistance and heat sealability It can be attached by applying heat.
  • the hot melt may be applied to the plate applied.
  • the immunochromatography strip 100 is attached to the bottom of the portion overlapping the signal detection pad 123 of the support 111, the two positions corresponding to both ends of the signal detection pad 123 It further comprises at least two or more bypass flow blocking partition member 125, including being attached.
  • three bypass flows including two bypass flow blocking partition members 125 are basically attached to two positions corresponding to both ends of the signal detection pad 123.
  • a blocking partition member it would be possible to have two basic bypass flow blocking partition members or a larger number of bypass flow blocking partition members.
  • such a bypass flow blocking partition member 125 may not be essential, but all liquid samples introduced through the inlet 215 above the sample pad 121 are analyzed by the capillary phenomenon.
  • the liquid sample is prevented from moving to the bypass flow path through the lower space of the support, at least in part, not only in the flow path such as sequentially moving to the suction pad 124 through the signal detection pad 123). Plays a desirable role. That is, the bypass flow blocking partition member 125 blocks the bypass flow of the liquid sample through the lower space of the support 111 to improve the reliability of the analysis results.
  • FIG. 11 is a perspective view illustrating an embodiment of a method for preparing an immunochromatography kit according to the present invention.
  • the method of manufacturing an immunochromatography kit includes a molding process for forming a cover disc 200 'to include a plurality of immunochromatography strip receiving spaces, and an inlet 215 in the cover disc 200'. ) Punching process to form a vent hole 225 and a punching method, a strip input process for introducing an immunochromatography strip 100 into each of the immunochromatographic strip receiving spaces of the cover disc 200 ', and a cover disc 200'.
  • the cover plate member made of soft transparent plastic material is heated.
  • the cover disc 200 ' which can be separated into a plurality of covers, is molded by pneumatic adsorption.
  • the mold set is connected to a means for applying heat and a means for forming a negative pressure for pneumatic adsorption, such as a vacuum pump, to form the cover disc 200 'by pneumatic adsorption while applying heat. Make it happen.
  • the number is not limited.
  • the flexible transparent plastic sheeting material may be cut to a predetermined size and supplied to the mold set, but preferably, the flexible transparent plastic sheeting material is supplied in a roll form having a predetermined width so that the cover molding is continuously performed.
  • the process may also be performed continuously in an interlocked manner.
  • the inlet 215 and the vent 225 are formed in each of the plurality of immunochromatographic strip accommodating spaces formed in the cover original plate 200 ′ through the cover molding process as described above by punching.
  • Each of the immunochromatographic strips 100 of the cover original plate 200 ′, which has been punched out, is prepared with one immunochromatography strip 100 prepared before assembly.
  • Such a strip feeding process is not one by one in each of the immunochromatography strip receiving space sequentially, but the immunochromatography strip (100) in all the immunochromatography strip receiving space provided in the cover disc 200 'through an automated production system. ) May be introduced at the same time.
  • a bottom plate attaching process is performed to attach the bottom plate member 300 'to the cover original plate 200' so as to close all of the plurality of immunochromatographic strip receiving spaces into which the immunochromatography strip 100 is introduced.
  • the bottom plate attaching process also includes a single bottom plate member 300 cut to a size corresponding to the size of the cover original plate 200 'so as to simultaneously close all of the plurality of immunochromatographic strip receiving space sets formed on the cover original plate 200'. ') Is attached to the cover disc 200' in a simplified manner.
  • the cover disc member provided in the form of one roll is continuously formed to form a set of cover discs having a plurality of immunochromatography strip receiving spaces at a time, wherein the base plate member is also interlocked in roll form.
  • the base plate attachment process may be performed to sequentially close all of the immunochromatographic strip receiving spaces formed on the cover disc by supply.
  • an immunochromatography kit assembly including a plurality of immunochromatography kits is completed, and the immunochromatography kit assembly is separated into a plurality of immunochromatography kits through a cutting process.
  • the immunochromatography kit manufacturing method according to the present invention considering the manufacturing process through an automated production system, all processes can be automated. In addition, instead of manufacturing one immunochromatography kit at a time through a series of manual processes, it is possible to produce multiple immunochromatography kits simultaneously through an automated series of processes, resulting in significant productivity improvements. You can do it. In addition, it is possible to reduce the use and consumption of low-cost raw materials, and to reduce the dependency on the labor force and to significantly reduce costs. Furthermore, there is no process of arranging the upper and lower housings separately from the conventional automation method, and instead of moving and covering the upper housings, the manufacturing process is simplified by replacing the upper housings with a continuous plate, thereby significantly increasing the production per hour. .
  • Monoclonal and goat anti-mouse immunoglobulin antibodies against canpabovirus were diluted with phosphate buffer, then sprayed onto the test and control lines of the nitrocellulose pad, respectively, using an injector and dried in a 37 ° C thermostat to immobilize them. I was.
  • the pads and the sample pads prepared in the steps A, B and C were sequentially adhered to the adhesive-coated polypropylene plate, so that the sample pad, the antibody-gold conjugate pad, the antibody immobilized nitrocellulose pad, and the absorption pad obtained above were obtained.
  • the strips were cut to a size of 0.5 ⁇ 70 mm after being superimposed in a stack.
  • nitrocellulose pads and antibody-gold conjugate pads were prepared in the same manner as in Example 1 except that monoclonal antibodies against human infective virus type B surface antigen (HBsAg) were used. Prepared. The absorbent pad was soaked in 10 wt% magnesium chloride aqueous solution with 1 mm thick pulp and allowed to soak in the pulp. Then, the absorbent pad was dried at 100 ° C. for 1 hour, and one side was cut into 20 x 300 mm with a porous film (polyethylene). To complete the immunochromatography strip kit as in Example 1,
  • nitrocellulose pads and antigen-gold conjugates in the same manner as in Example 1 except for using monoclonal antibodies against human chorionic gonadotropin (hCG) antigens.
  • the pad was prepared.
  • the absorbent pad was soaked in 1 mm thick pulp in an aqueous solution of 10% by weight calcium chloride and 10% by weight magnesium chloride. The absorbent was allowed to soak in the pulp and dried at 100 ° C for 1 hour. ) And cut into 20 x 300 mm, and each of the immunochromatographic strip kits as in Example 1 was inserted into the housing through an automated equipment and sealed cut.
  • a sheet of dried PET 0.4 mm thick roll is passed through a hot plate continuously, moved to a housing mold, and pneumatic pressure is applied to open a cover model, and punching several inlets for easy urine sample input in a subsequent process.
  • Ultrasonic sealing process by inserting the cutting process to fit the size of the kit was made continuously in an automated equipment to complete the kit.
  • the prepared kits were stored for 1 month, 6 months, 12 months and 18 months to remove the protective film attached to the sample inlet, and each of the hCG positive urine and one negative sample was tested.
  • the test result confirmed that the analysis was performed with good sensitivity despite the passage of 18 months.

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Abstract

L'invention se rapporte à une trousse d'immunochromatographie contenant une bandelette d'immunochromatographie pour immunoessai et à un procédé de fabrication de la trousse. La trousse précitée contient une bandelette d'immunochromatographie, un couvercle, et une plaque inférieure qui est attachée au côté inférieur du couvercle de façon à fermer un boîtier de bandelette d'immunochromatographie. Le couvercle comprend: le boîtier de bandelette d'immunochromatographie; un orifice d'entrée conique situé du côté supérieur d'un tampon à échantillon, qui est relié à une unité boîtier de tampon à échantillon et qui dirige un échantillon liquide vers le tampon de détection à des fins d'analyse; et un ou plusieurs trous situés du côté supérieur d'un tampon d'absorption, destinés à être reliés à une unité boîtier de tampon d'absorption. Le boîtier de bandelette d'immunochromatographie en plastique transparent comprend : l'unité boîtier de tampon à échantillon à une extrémité de la bandelette d'immunochromatographie, destinée à contenir le tampon à échantillon et un tampon conjugué; l'unité boîtier de tampon d'absorption à l'autre extrémité de la bandelette d'immunochromatographie; et une unité boîtier de tampon de détection de signal, située entre l'unité boîtier de tampon à échantillon et l'unité boîtier de tampon d'absorption.
PCT/KR2009/001408 2008-03-24 2009-03-19 Trousse d'immunochromatographie et procédé de fabrication WO2009119993A2 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
KR20080027004 2008-03-24
KR10-2008-0027004 2008-03-24
KR10-2009-0017090 2009-02-27
KR1020090017090A KR20090101823A (ko) 2008-03-24 2009-02-27 면역 크로마토그래피 키트 및 그 제조방법

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WO2009119993A2 true WO2009119993A2 (fr) 2009-10-01
WO2009119993A3 WO2009119993A3 (fr) 2009-11-26

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CN108780076A (zh) * 2016-01-27 2018-11-09 隐蔽色彩股份有限公司 用于检测液体中目标物质的可穿戴装置
CN111551710A (zh) * 2020-05-27 2020-08-18 中国农业科学院烟草研究所 一种检测多菌灵残留的免疫层析试剂盒及方法
CN113791210A (zh) * 2021-09-17 2021-12-14 石家庄洹众生物科技有限公司 一种同时检测基质金属蛋白酶-8和白细胞介素-6的试剂条、装置及其应用

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KR100735080B1 (ko) * 2006-08-03 2007-07-03 (주)래피젠 면역크로마토그래피 스트립 및 이를 포함하는 키트

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US5622871A (en) * 1987-04-27 1997-04-22 Unilever Patent Holdings B.V. Capillary immunoassay and device therefor comprising mobilizable particulate labelled reagents
KR100421346B1 (ko) * 1999-06-21 2004-03-06 마츠시타 덴끼 산교 가부시키가이샤 크로마토그래피 정량 측정 장치 및 그의 제조 방법
KR100735080B1 (ko) * 2006-08-03 2007-07-03 (주)래피젠 면역크로마토그래피 스트립 및 이를 포함하는 키트

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108780076A (zh) * 2016-01-27 2018-11-09 隐蔽色彩股份有限公司 用于检测液体中目标物质的可穿戴装置
CN108780049A (zh) * 2016-01-27 2018-11-09 隐蔽色彩股份有限公司 用于检测目标物质的装置、系统和方法
JP2019510208A (ja) * 2016-01-27 2019-04-11 アンダーカバー カラーズ，インク． 液体中の標的物質を検出するためのウェアラブル装置
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EP3408665A4 (fr) * 2016-01-27 2020-03-18 Undercover Colors, Inc. Appareil pouvant être porté pour détecter une substance cible dans un liquide
CN111551710A (zh) * 2020-05-27 2020-08-18 中国农业科学院烟草研究所 一种检测多菌灵残留的免疫层析试剂盒及方法
CN111551710B (zh) * 2020-05-27 2023-03-14 中国农业科学院烟草研究所 一种检测多菌灵残留的免疫层析试剂盒及方法
CN113791210A (zh) * 2021-09-17 2021-12-14 石家庄洹众生物科技有限公司 一种同时检测基质金属蛋白酶-8和白细胞介素-6的试剂条、装置及其应用

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