WO2024106695A1 - Kit de diagnostic - Google Patents
Kit de diagnostic Download PDFInfo
- Publication number
- WO2024106695A1 WO2024106695A1 PCT/KR2023/011894 KR2023011894W WO2024106695A1 WO 2024106695 A1 WO2024106695 A1 WO 2024106695A1 KR 2023011894 W KR2023011894 W KR 2023011894W WO 2024106695 A1 WO2024106695 A1 WO 2024106695A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- pad
- area
- housing
- timing
- test
- Prior art date
Links
- 238000003745 diagnosis Methods 0.000 title description 5
- 238000012360 testing method Methods 0.000 claims abstract description 64
- 239000012528 membrane Substances 0.000 claims abstract description 26
- 230000021615 conjugation Effects 0.000 claims abstract description 23
- 238000009007 Diagnostic Kit Methods 0.000 claims description 29
- 230000001681 protective effect Effects 0.000 claims description 12
- 230000002745 absorbent Effects 0.000 claims description 3
- 239000002250 absorbent Substances 0.000 claims description 3
- 238000010186 staining Methods 0.000 claims description 3
- 238000010586 diagram Methods 0.000 description 8
- 238000007689 inspection Methods 0.000 description 5
- 238000000034 method Methods 0.000 description 5
- 238000010521 absorption reaction Methods 0.000 description 4
- 210000002700 urine Anatomy 0.000 description 4
- 230000008901 benefit Effects 0.000 description 3
- 239000008280 blood Substances 0.000 description 3
- 210000004369 blood Anatomy 0.000 description 3
- 238000012123 point-of-care testing Methods 0.000 description 3
- 239000003814 drug Substances 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 210000003296 saliva Anatomy 0.000 description 2
- 239000013077 target material Substances 0.000 description 2
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 206010033372 Pain and discomfort Diseases 0.000 description 1
- 239000003522 acrylic cement Substances 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
- 238000003491 array Methods 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 238000002405 diagnostic procedure Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000000049 pigment Substances 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Images
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
- B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
- B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
- B01L3/5023—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures with a sample being transported to, and subsequently stored in an absorbent for analysis
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L9/00—Supporting devices; Holding devices
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L9/00—Supporting devices; Holding devices
- B01L9/52—Supports specially adapted for flat sample carriers, e.g. for plates, slides, chips
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/02—Identification, exchange or storage of information
- B01L2300/025—Displaying results or values with integrated means
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/06—Auxiliary integrated devices, integrated components
- B01L2300/069—Absorbents; Gels to retain a fluid
Definitions
- the present invention relates to a diagnostic kit.
- POCT Point-Of-Care Testing
- On-site testing is a test conducted outside of a centralized laboratory and refers to equipment that can be used by the general public without specialized knowledge.
- the existing diagnostic method in vitro diagnosis, has been an invasive method of piercing the skin with a needle, collecting blood, and measuring it, which has the disadvantage of causing pain and discomfort to the test subject.
- diagnostic kits test the presence of a single or multiple substances in a liquid sample, and have the advantage of simplifying the diagnosis of a specific disease by reacting samples such as blood, saliva, or urine with a specific drug.
- diagnosis using a diagnostic kit has the advantage of being able to easily collect samples without external stimulation and being independent of location.
- Patent Document 0001 Republic of Korea Patent Publication No. 10-2181097 (“Specimen pad for medical diagnostic kit and manufacturing method thereof”, Enbioneer Co., Ltd., November 20, 2020)
- the present invention aims to solve the problem of providing a diagnostic kit including a timing pad.
- a diagnostic kit is provided to solve the above-mentioned problems.
- the diagnostic kit consists of an upper plate and a lower plate, and includes a window area formed of a full window in the center of the upper plate, a plurality of windows spaced apart from the window area on one side in the width direction of the window area, and a plurality of devices arranged parallel and spaced apart in the width direction.
- a test pad area including a hole, a sample pad provided on one side in the longitudinal direction of the window area and one side in the longitudinal direction of the test pad area, and disposed on an edge of one side in the longitudinal direction of the test pad area.
- a housing including a timing pad area including a hole; a test pad located in the test pad area; and an NC membrane, a conjugation pad provided in contact with one side in the width direction of the NC membrane and provided in contact with an upper surface of the NC membrane, and extending from the other side to one side in the width direction of the conjugation pad.
- a timing pad located in the timing pad area including a sample pad that is disposed in a sample pad hole that is an edge of one side in the longitudinal direction of the test pad area and is provided in contact with an upper surface of the conjugation pad; Includes.
- the timing pad may further include an absorption pad disposed to extend on the other side of the NC membrane in the width direction and provided in contact with the upper surface of the NC membrane.
- a bar-shaped groove whose vertical length corresponds to the length of the NC membrane may be formed on one side in the longitudinal direction of the lower plate of the housing.
- the timing pad area may be provided to extend from one longitudinal side of the window area formed on the upper plate of the housing to the sample pad hole at the same position as the bar-shaped groove formed on the lower plate of the housing.
- the timing pad area may be provided with a hole formed on one side in the longitudinal direction of the window area formed on the upper plate of the housing at the same position as a bar-shaped groove formed on the lower plate of the housing, and the sample pad hole may be spaced apart from each other. .
- the housing may have a reference line displayed at a predetermined point of the timing pad area formed on one side in the longitudinal direction of the window area.
- the conjugation pad may contain a dye for staining the specimen.
- It may further include a mesh attached to the inspection pad, and a protective film attached to the housing including the mesh.
- the mesh is a hydrophilic mesh, and may be formed to be removable from the housing together with the protective film.
- the specimen may reach the baseline of the timing pad after a certain period of time.
- FIG. 1 is a diagram for explaining a diagnostic kit according to an embodiment of the present invention.
- Figure 2 is a diagram for explaining the housing.
- Figures 3 and 4 are diagrams for explaining the housing of a diagnostic kit according to another embodiment of the present invention.
- Figure 5 is a diagram for explaining a cross section of a timing pad.
- Figure 6 is a flowchart for explaining a testing method using a diagnostic kit according to an embodiment of the present invention.
- a part includes a certain element throughout the specification, this means that, unless specifically stated to the contrary, it does not exclude other elements but may further include other elements.
- terms such as “unit”, “module”, “unit”, etc. used in the specification mean a unit that processes at least one function or operation, and include software, hardware components such as FPGA or ASIC, or software and hardware. It can be implemented by combining .
- terms such as “part”, “module”, and “unit” are not limited to software or hardware.
- a “part”, “module”, “unit”, etc. may be configured to reside on an addressable storage medium and may be configured to reproduce on one or more processors.
- terms such as “part”, “module”, and “unit” refer to components such as software components, object-oriented software components, class components, and task components, and processes. Contains fields, functions, properties, procedures, subroutines, segments of program code, drivers, firmware, microcode, circuits, data, databases, data structures, tables, arrays, and variables. .
- first may be named a second component without departing from the scope of the present invention, and similarly, the second component may also be named a first component.
- the term “and/or” includes any one item among a plurality of related items or a combination of a plurality of related items.
- FIG. 1 is a diagram for explaining a diagnostic kit according to an embodiment of the present invention.
- the diagnostic kit 1 includes a housing 100, a mesh 200, a timing pad 300, and a protective film 400.
- the diagnostic kit 1 is formed as a device that guides the user to confirm the test when the sample dispensed on the mesh 200 in the housing 100 reaches a predetermined line on the timing pad 300.
- the sample may include body fluids such as urine, saliva, and blood.
- the housing 100 consists of an upper plate 110 and a lower plate 120.
- x represents the longitudinal direction
- y represents the width direction
- z represents the thickness direction
- Figure 2 is a diagram for explaining the housing.
- the housing 100 is composed of a timing pad area 111, a window area 112, and a test pad area 113.
- the window area 1120 may be formed as a full window in the center of the upper plate 110 of the housing 100.
- the window area 112 may be a space for displaying a QR code that can confirm the inspection.
- the test pad area 113 may be provided on one side of the window area 112 formed in the upper plate 110 of the housing 100 in the width direction (y) and spaced apart from the window area 112.
- the test pad area 113 may include a plurality of holes arranged in parallel and spaced apart in the width direction (y).
- a plurality of holes may be formed so that the inspection pad and the mesh can be aligned.
- the test pad area 113 may be formed so that a plurality of test pads can be positioned.
- the timing pad area 111 may be provided on one side of the window area 112 in the longitudinal direction (x) and on one side of the test pad area 113 in the longitudinal direction (x).
- the timing pad area 111 may include a sample pad hole disposed at an edge of one side of the test pad area 113 in the longitudinal direction (x).
- the timing pad area 111 may have a bar-shaped groove whose vertical length corresponds to the length of the NC membrane formed on one side in the longitudinal direction (x) of the lower plate 120 of the housing 100.
- the timing pad area 111 is one part of the window area 112 in the longitudinal direction (x) formed on the upper plate 110 of the housing 100 at the same position as the bar-shaped groove formed on the lower plate 120 of the housing 100. It may be provided to extend from the side to the sample pad hole.
- timing pad area 111 is located at the same position as the bar-shaped groove formed in the lower plate 120 of the housing 100, in the longitudinal direction (x) of the window area 112 formed in the upper plate 110 of the housing 100.
- the hole formed on one side of the sample pad hole may be spaced apart from each other.
- the housing 11 may have a reference line displayed at a predetermined point of the timing pad area 111 formed on one side of the window area 112 in the longitudinal direction (x).
- the housing 100 may have an upper plate 110 and a lower plate 120 formed as one piece, and a plurality of test pads may be included between the upper plate 110 and the lower plate 120 of the housing 100.
- Figures 3 and 4 are diagrams for explaining the housing of a diagnostic kit according to another embodiment of the present invention.
- the housing 100 may be configured as a grid type so that a plurality of inspection pads are all placed within each grid.
- the grid-type housing 100 may be formed to prevent interference between enzymes of each test pad.
- the housing 100 may provide a space for attaching a hydrophilic mesh by creating square grooves on the grid.
- the housing 100 is a window type, and is formed to allow a slight error in the alignment of the test pad by creating a window through the test pad area 113. It can be.
- the groove made at the top of the window area 112 may be the timing pad area 111, and the housing 100 connects the test pad area 113 and the timing pad area 111 to perform timing. It can be designed to check the pad.
- the timing pad 300 may be formed so that the color is developed up to the reference line at a certain time so that the user can determine the time for inspection.
- the timing pad 300 may be composed of a sample pad 310, a conjugation pad 320, an NC membrane 330, and an absorption pad 340.
- Figure 5 is a diagram for explaining a cross section of a timing pad.
- the timing pad 300 is formed in a lateral flow assay (LFA) strip structure.
- LFA lateral flow assay
- the NC membrane 330 may be formed at the bottom.
- the conjugation pad 320 may be provided in contact with one side of the NC membrane 330 in the width direction (y).
- the conjugation pad 320 may be provided in contact with the upper surface of the NC membrane 330.
- the conjugation pad 320 may contain a dye for staining the specimen.
- the sample pad 310 may be arranged to extend from the other side to one side in the width direction (y) of the conjugation pad 320.
- the sample pad 310 may be provided to be disposed in a sample pad hole that is an edge of one side of the test pad area 113 in the longitudinal direction (x).
- the sample pad 310 may be provided in contact with the upper surface of the conjugation pad 320.
- the absorption pad 340 is disposed to extend on the other side of the NC membrane 330 in the width direction (y), and may be provided in contact with the upper surface of the NC membrane 330.
- Mesh 200 may be attached to the test pad.
- the mesh 200 may be fixed to a plurality of holes formed in the housing 100 and aligned at the same position as the test pad.
- the mesh 200 may be formed as a hydrophilic mesh so that urine is evenly applied to the test pads so that each test pad can produce an accurate colorimetric reaction.
- the mesh 200 distributes the sample uniformly to the test pad so that only a certain amount of solution reacts to the sample pad or test pad.
- the mesh 200 may be made of the same material as the conjugation pad 320, and the mesh 200 and the conjugation pad 320 may be used interchangeably.
- the protective film 400 includes a mesh and may be attached to the housing 100 .
- the protective film 400 is composed of a biodegradable film tape and a water-soluble acrylic adhesive tape and is attached to the upper surface of the housing 100.
- the protective film 400 including the mesh 200 may be formed to be detachable from the housing 100 by a user.
- Figure 6 is a flowchart for explaining a testing method using a diagnostic kit according to an embodiment of the present invention.
- the user dispenses a sample onto the test pad (S100).
- the sample is uniformly dispensed onto the test pad by the hydrophilic mesh, and is also dispensed onto the sample pad 310 located in the test pad area 113.
- the user separates the protective film 400 from the housing 100 to remove excess residual sample remaining on the housing 100 (S110).
- the protective film 400 includes a mesh 200 and is attached to the housing 100, and the mesh 200 and the protective film 400 can be removed from the housing 100 by the user.
- the sample As soon as the sample is dispensed, it begins to react with the test pad and sample pad 310, and the sample is stained by the conjugation pad 320 (S120).
- the conjugation pad 320 may contain pigment.
- the stained sample reaches the reference line of the timing pad 300 through the NC membrane 330 (S130).
- the color of the timing pad 300 may be shifted to yellow, and in the case of water, the color of the timing pad 300 may be shifted to a transparent color or white.
- the timing pad 300 can determine whether the test target material is present through the conjugation pad 320.
- the sample dispensed on the test pad reacts through the timing pad 300 to determine the test target material.
- the diagnostic kit 1 allows the stained sample to move for 60 seconds to reach the reference line of the timing pad 300, but this is not limited.
- the certain time may vary depending on the length, width, and type of the NC membrane 330.
- the user can confirm that 60 seconds have passed by confirming that the dyed sample has reached the reference line of the timing pad 300.
- the absorption pad 340 can absorb excess sample moved through the NC membrane 330.
- the user can check the status of the test pad by accessing the QR code displayed in the window area 112.
- the dyed sample reaches the reference line of the timing pad 300 after 60 seconds, and the user can measure the QR test time through the reference line of the timing pad 300 even if the time is not measured. can confirm.
- the sample when a sample reacts with the test pad and sample pad, the sample can reach the baseline of the timing pad after a certain period of time, so the user can determine the QR test time through the reference line of the timing pad even if the time is not measured. Since it can be confirmed, it has high industrial applicability.
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Clinical Laboratory Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Analytical Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Hematology (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
La présente invention comprend : un boîtier ; un tampon de test ; et un tampon de synchronisation. Le boîtier est constitué d'une plaque supérieure et d'une plaque inférieure et comprend : une zone de fenêtre formée sous la forme d'une fenêtre complète au centre de la plaque supérieure ; une zone de tampon de test prévue sur une surface latérale dans le sens de la largeur de la zone de fenêtre et espacée de la zone de fenêtre et comprenant une pluralité de trous agencés en parallèle dans le sens de la largeur et espacés les uns des autres ; et des zones de tampon de synchronisation prévues sur une surface latérale dans le sens longitudinal de la zone de fenêtre et sur une surface latérale dans le sens longitudinal de la zone de tampon de test et comprenant un trou de tampon d'échantillon disposé au bord d'une surface latérale dans le sens longitudinal de la zone de tampon de test. Le tampon de test est situé dans la zone de tampon de test. Le tampon de synchronisation est situé dans chacune des zones de tampon de synchronisation et comprend : une membrane NC ; un tampon de conjugaison prévu en contact avec une surface latérale dans le sens de la largeur de la membrane NC et en contact avec la surface supérieure de la membrane NC ; et un tampon d'échantillon agencé pour s'étendre vers une surface latérale à partir de l'autre surface latérale dans le sens de la largeur du tampon de conjugaison, prévu pour être disposé dans le trou de tampon d'échantillon au niveau du bord d'une surface latérale dans le sens longitudinal de la zone de tampon de test, et prévu en contact avec la surface supérieure du tampon de conjugaison.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR1020220151498A KR20240070098A (ko) | 2022-11-14 | 2022-11-14 | 진단 키트 |
KR10-2022-0151498 | 2022-11-14 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2024106695A1 true WO2024106695A1 (fr) | 2024-05-23 |
Family
ID=91084975
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/KR2023/011894 WO2024106695A1 (fr) | 2022-11-14 | 2023-08-11 | Kit de diagnostic |
Country Status (2)
Country | Link |
---|---|
KR (1) | KR20240070098A (fr) |
WO (1) | WO2024106695A1 (fr) |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR200407584Y1 (ko) * | 2005-11-23 | 2006-02-01 | 최세묵 | 일자형 다중 진단키트 |
KR20200086905A (ko) * | 2019-01-10 | 2020-07-20 | 주식회사 옵티바이오 | 백혈구 계수용 챔버를 구비한 체외 진단 키트 |
KR20210096724A (ko) * | 2020-01-28 | 2021-08-06 | 한국전자통신연구원 | 양각 패턴을 포함하는 분기 구조의 진단 키트 |
KR102339013B1 (ko) * | 2020-11-16 | 2021-12-14 | 주식회사 옵티바이오 | 양수 검체 내 mmp-8 정량화가 가능한 체외 진단 키트 |
US20220080406A1 (en) * | 2019-01-31 | 2022-03-17 | Asahi Kasei Kabushiki Kaisha | Absorbent Pad for Immunochromatographic Diagnosis Kit |
Family Cites Families (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR102181097B1 (ko) | 2020-07-15 | 2020-11-20 | 주식회사 엔바이오니아 | 메디컬 진단키트용 검체패드 및 그 제조방법 |
-
2022
- 2022-11-14 KR KR1020220151498A patent/KR20240070098A/ko unknown
-
2023
- 2023-08-11 WO PCT/KR2023/011894 patent/WO2024106695A1/fr unknown
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR200407584Y1 (ko) * | 2005-11-23 | 2006-02-01 | 최세묵 | 일자형 다중 진단키트 |
KR20200086905A (ko) * | 2019-01-10 | 2020-07-20 | 주식회사 옵티바이오 | 백혈구 계수용 챔버를 구비한 체외 진단 키트 |
US20220080406A1 (en) * | 2019-01-31 | 2022-03-17 | Asahi Kasei Kabushiki Kaisha | Absorbent Pad for Immunochromatographic Diagnosis Kit |
KR20210096724A (ko) * | 2020-01-28 | 2021-08-06 | 한국전자통신연구원 | 양각 패턴을 포함하는 분기 구조의 진단 키트 |
KR102339013B1 (ko) * | 2020-11-16 | 2021-12-14 | 주식회사 옵티바이오 | 양수 검체 내 mmp-8 정량화가 가능한 체외 진단 키트 |
Also Published As
Publication number | Publication date |
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KR20240070098A (ko) | 2024-05-21 |
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