WO2021177548A1 - Kit de dosage immunologique à écoulement latéral entièrement automatique et dispositif de mesure pour la mesure de multiples biomarqueurs de la salive - Google Patents

Kit de dosage immunologique à écoulement latéral entièrement automatique et dispositif de mesure pour la mesure de multiples biomarqueurs de la salive Download PDF

Info

Publication number
WO2021177548A1
WO2021177548A1 PCT/KR2020/016121 KR2020016121W WO2021177548A1 WO 2021177548 A1 WO2021177548 A1 WO 2021177548A1 KR 2020016121 W KR2020016121 W KR 2020016121W WO 2021177548 A1 WO2021177548 A1 WO 2021177548A1
Authority
WO
WIPO (PCT)
Prior art keywords
reaction
rod
lfa
sample
saliva
Prior art date
Application number
PCT/KR2020/016121
Other languages
English (en)
Korean (ko)
Inventor
유성덕
Original Assignee
주식회사 이바이오젠
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.)
Filing date
Publication date
Application filed by 주식회사 이바이오젠 filed Critical 주식회사 이바이오젠
Publication of WO2021177548A1 publication Critical patent/WO2021177548A1/fr

Links

Images

Classifications

    • 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
    • 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
    • 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
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00029—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with flat sample substrates, e.g. slides
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00722—Communications; Identification
    • 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
    • B01L2300/0627—Sensor or part of a sensor is integrated
    • 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
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B01L2300/0825—Test strips
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00029—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with flat sample substrates, e.g. slides
    • G01N2035/00099—Characterised by type of test elements
    • G01N2035/00108—Test strips, e.g. paper

Definitions

  • the present invention relates to an automatic side flow immunoassay strip analysis device, and more particularly, to a side flow immunoassay strip automatic analysis device for measuring multiple biomarkers in saliva and a method for detecting multiple biomarkers from saliva using the same it's about
  • LFA Lateral Flow Immuno Assay
  • the diagnostic strip used in the lateral flow immunoassay includes an elongated rectangular support made of an adhesive plastic material, and a sample pad, a conjugate pad, a detection pad, and an absorption pad, which are disposed approximately sequentially from one side to the other on the support. is made including
  • the lateral flow immunoassay method is used for diagnosis in various medical/environmental fields or for non-medical self-testing because the analysis principle is simple, the analysis time is short, and the production cost is low.
  • the lateral flow immunoassay is widely used for field analysis because it is inexpensive, easy to carry and fast detection, and can be easily used by the general public without specialized skills.
  • the side-flow immunoassay is largely divided into a sandwich assay method using primary and secondary antibodies against a target substance and a competitive assay method using only a single antibody.
  • a representative example of using the sandwich assay method of lateral flow immunoassay is urine chorionic gonadotropin (hCG), such as "a kit for diagnosing a cow's pregnancy and a method for diagnosing a pregnancy using the kit" of Korean Patent Registration No. 10-0930517. It is a pregnancy diagnostic kit that collects from and detects whether you are pregnant.
  • hCG urine chorionic gonadotropin
  • hCG injected into the sample pad flows along the membrane (detection pad) by capillary action while binding to the gold nanoparticle-antibody conjugate immobilized on the conjugate pad.
  • the gold nanoparticles which are detection indicators (probes)
  • develop color due to the binding of the secondary antibody immobilized to the detection region the result can be confirmed.
  • the side-flow immunoassay method visually evaluates the detection factors by the color development of gold nanoparticles that form an immunocomplex with the target material.
  • the side-flow immunoassay of the competitive assay method is mainly used to detect small-molecular substances, and a representative example is a drug test kit.
  • the target material injected into the sample pad flows along the membrane (detection pad) by capillary action while binding to the gold nanoparticle-antibody conjugate immobilized on the conjugate pad.
  • the gold nanoparticle-antibody conjugate to which the target material is bound cannot bind to the target material-protein complex immobilized in the detection region, and accordingly, the gold nanoparticles, which are detection indicators (probes), do not collect on the detection line, resulting in negative color development. weaker than in the case of the sample.
  • the side-flow immunoassay of the competitive assay method evaluates the detection factors by visually confirming that the gold nanoparticles, which form an immunocomplex with the target substance, cannot bind to the detection line, resulting in weak or no color development.
  • the lateral flow immunoassay method is not excellent in analytical sensitivity as it relies on visual identification evaluation, and there is a problem in that quantitative analysis is difficult.
  • the conventional side-flow immunoassay has low measurable sensitivity, so it is difficult to measure a sample requiring higher sensitivity.
  • the present invention was invented to improve the above problems. Instead of using only one side of the side flow immunoassay strip, more detection strips can be mounted, and a plurality of detection strips can be detected using the internal rotation device and detection device.
  • An object of the present invention is to provide a fully automatic lateral flow immunoassay kit and measuring device that can detect substances more accurately and conveniently.
  • the present invention stores the data on the color development ratio of the control line and the test line for each concentration using the sample for each concentration of the target material in determining the LFA strip reaction, and the reaction between the sample and the LFA strip whose concentration of the target material is unknown.
  • the concentration of the target substance in the sample is calculated and displayed by comparing it with the existing data.
  • the present invention easily detects and analyzes a target material regardless of skill level by using the fully automatic side flow immunoassay kit and measuring device for measuring multiple biomarkers in saliva according to the present invention, and a series of detection and analysis processes This is to provide a measurement method that can significantly improve the efficiency of analysis by automatically performing
  • the present invention is a sample collection unit comprising a cotton for collecting a sample including saliva in the oral cavity of the subject to be measured;
  • a polygonal columnar body having an internal space into which the cotton for collection is inserted and having a plurality of reaction surfaces in the vertical direction, and a lateral flow immunoassay (hereinafter referred to as Lateral Flow ImmunoAssay) provided in plurality at the lower side of the plurality of reaction surfaces, respectively a strip for LFA) and an LFA cartridge accommodating the lower part of the main body and including a reaction container in which the reaction solution to be reacted with the sample discharged from the cotton for collection is accommodated;
  • a side flow immunoassay kit for measuring multiple biomarkers in saliva, characterized in that it comprises a reaction inducing unit for allowing the reaction solution from which the sample is eluted and the LFA strip to react.
  • the present invention is a measurement having an internal space capable of accommodating a lateral flow immunoassay (hereinafter referred to as LFA) cartridge comprising a polygonal column-shaped body and a reaction vessel accommodating the lower part of the body and containing a reaction solution.
  • LFA lateral flow immunoassay
  • housing a drive transmission unit for generating a driving force for forward and reverse rotation of the docking station; a CCD camera mounted on one side of the measuring housing to photograph a test line formed by the reaction solution reacting to the LFA strip provided on the lower side of the plurality of reaction surfaces provided in the vertical direction of the body; and a processing unit that calculates the concentration of the target substance in the sample by comparing and analyzing the reaction determination data stored in advance from the test line photographed with the CCD camera. It may be possible to provide a fully automatic measuring device for measuring.
  • a first step of collecting a sample including saliva in the oral cavity of the measurement subject with a cotton for collection A second step of eluting the sample into the reaction solution in the LFA cartridge by putting the cotton for collection into the lateral flow immunoassay (LFA) cartridge seated in the measurement housing; After the first time elapses, the cotton for collection is applied to the LFA cartridge so that the reaction solution from which the sample is eluted is reacted with a plurality of strips for LFA respectively formed on a plurality of reaction surfaces provided on the polygonal columnar body of the LFA cartridge.
  • LFA lateral flow immunoassay
  • the present invention does not utilize only a single side of the LFA strip, unlike the prior art and existing products, and provides a detection strip for each reaction surface of the polygonal prism-shaped body, so that more detection strips can be mounted. It has the advantage of being able to detect a substance.
  • the present invention is provided in the measurement housing through the drive transmission unit for rotating and elevating the LFA cartridge and the sample collection unit, and the processing unit for calculating the concentration of the target material compared to the prior art and the existing products more diverse and more target material It has the advantage of being able to detect more accurately, quickly and conveniently.
  • the measuring device stores data on the color development ratio of the control line and the test line for each concentration by using the sample for each concentration of the target material in determining the reaction of the LFA strip, and measures the concentration of the target material.
  • the concentration of the target material in the sample is calculated and displayed directly through the display panel. Therefore, it has the advantage that rapid, high reproducibility, and high-sensitivity analysis are possible.
  • FIG. 1 is a conceptual diagram schematically illustrating the overall structure of an LFA kit according to an embodiment of the present invention and a fully automatic measuring device for measuring multiple biomarkers of saliva with this kit.
  • Figure 2 is a conceptual diagram schematically showing the structure of the LFA kit according to an embodiment of the present invention.
  • FIG. 3 is a conceptual diagram schematically showing the structure of an LFA kit according to another embodiment of the present invention.
  • FIG. 4 is a conceptual diagram schematically illustrating the overall structure of a fully automatic measuring device for measuring multiple biomarkers of saliva according to an embodiment of the present invention.
  • FIG. 5 is a conceptual diagram schematically illustrating the overall structure of a fully automatic measuring device for measuring multiple biomarkers of saliva according to another embodiment of the present invention.
  • FIG. 6 is a conceptual diagram schematically illustrating the overall structure of an LFA kit according to another embodiment of the present invention and a fully automatic measuring device for measuring multiple biomarkers of saliva with this kit.
  • FIG. 7 is a conceptual diagram schematically showing the overall structure of the LFA kit according to another embodiment of the present invention.
  • FIG. 8 is a conceptual diagram schematically illustrating the overall structure of an LFA kit according to another embodiment of the present invention and a fully automatic measuring device for measuring multiple biomarkers of saliva with this kit.
  • FIG 9 and 10 are conceptual views schematically showing the overall structure of the LFA kit according to another embodiment of the present invention.
  • FIG. 11 is a block diagram sequentially illustrating a method for detecting a target material using a fully automatic measuring device for measuring multiple biomarkers in saliva with a side flow immunoassay kit according to an embodiment of the present invention.
  • FIG. 12 is a conceptual diagram sequentially illustrating a method for detecting a target material using a fully automatic measuring device for measuring multiple biomarkers in saliva with a side flow immunoassay kit according to an embodiment of the present invention.
  • FIG. 1 is a conceptual diagram schematically illustrating the overall structure of an LFA kit according to an embodiment of the present invention and a fully automatic measuring device for measuring multiple biomarkers in saliva with this kit.
  • Figure 2 is a conceptual diagram schematically showing the structure of the LFA kit 100 according to an embodiment of the present invention.
  • Figure 3 is a conceptual diagram schematically showing the structure of the LFA kit 100 according to another embodiment of the present invention.
  • FIG. 4 is a conceptual diagram schematically illustrating the overall structure of the fully automatic measuring device 200 for measuring multiple biomarkers of saliva according to an embodiment of the present invention.
  • FIG. 5 is a conceptual diagram schematically illustrating the overall structure of a fully automatic measuring device for measuring multiple biomarkers of saliva according to another embodiment of the present invention.
  • Figure 6 is a conceptual diagram schematically showing the overall structure of the LFA kit 100 according to another embodiment of the present invention and a fully automatic measuring device for measuring multiple biomarkers of saliva with this.
  • Figure 7 is a conceptual diagram schematically showing the overall structure of the LFA kit 100 according to another embodiment of the present invention.
  • FIG. 8 is a conceptual diagram schematically illustrating the overall structure of the LFA kit 100 according to another embodiment of the present invention and a fully automatic measuring device for measuring multiple biomarkers of saliva with this.
  • Figure 9 and Figure 10 is a conceptual diagram schematically showing the overall structure of the LFA kit 100 according to another embodiment of the present invention.
  • FIG. 11 is a block diagram sequentially illustrating a method for detecting a target material using a fully automatic measuring device for measuring multiple biomarkers in saliva with a side flow immunoassay kit according to an embodiment of the present invention.
  • FIG. 12 is a conceptual diagram sequentially illustrating a method for detecting a target material using a fully automatic measuring device for measuring multiple biomarkers in saliva with a side flow immunoassay kit according to an embodiment of the present invention.
  • reference numeral 117 denotes a buffer container for saliva.
  • the present invention has a structure including a Lateral Flow Immuno Assay (LFA) kit, that is, an LFA kit 100 and a measuring device 200, as shown.
  • LFA Lateral Flow Immuno Assay
  • the LFA kit 100 has a structure including a sample collecting unit 110 , an LFA cartridge 120 , and a reaction inducing unit 130 .
  • the sample collection unit 110 includes a cotton 111 for collection from which a sample including saliva is collected in the oral cavity of a measurement subject.
  • the LFA cartridge 120 has an internal space into which the collecting cotton 111 is inserted, and a polygonal column-shaped body 121 having a plurality of reaction surfaces 121r in the vertical direction, and a plurality of reaction surfaces 121r lower It includes a strip 122 for LFA provided in plurality on the side, and a reaction vessel 123 that accommodates the lower portion of the body 121 and accommodates the reaction solution in which the sample discharged from the cotton 111 for collection is reacted. .
  • the reaction inducing unit 130 reacts with the reaction solution from which the sample is eluted and the strip 122 for LFA.
  • the sample collecting unit 110 may further include a first rod 112a having a lower end to which the collecting cotton 111 is mounted and an upper end coupled to the fixing member 250 of the measuring device.
  • sample collection unit 110 may further include a handle 113 provided at the upper end of the rod 112 and having an upper surface in which a coupling groove 113g coupled to the fixing member 250 of the measuring device is recessed. .
  • sample collection unit 110 may further include a separation preventing piece 114 extending from the outer peripheral surface of the lower side of the first rod 112a and regulating the separation of the cotton 111 for collection to the upper side.
  • sample collecting unit 110 may further include a male thread 115 formed along the outer peripheral surface of the lower end of the first rod 112a and detachably coupled to the stopper 131 .
  • the collecting cotton 111 is coupled through the lower end of the first rod 112a having the male thread 115 formed therein.
  • the upper surface of the collecting cotton 111 is in contact with the lower surface of the separation prevention piece 114, and the lower end of the first rod 112a is detachably coupled with the stopper 131 of the reaction inducing unit 130. 111) is preferably exposed from the lower surface.
  • the main body 121 may be provided in the shape of a polygonal prism manufactured by adding or subtracting the number of the response surfaces 121r according to the type of measurable target material such as a triangular prism, a quadrangular prism, or a hexagonal prism.
  • reaction vessel 123 may have an inner surface facing the plurality of reaction surfaces 121r on which the LFA strip 122 is mounted.
  • a buffer for saliva which is a reaction solution in which the collected sample is dissolved, flows out from the lower end of the body 121 through the reaction inducing unit 130 and reacts with the LFA strip 122 in the reaction vessel 123 ) so that the inner surface faces the reaction surface 121r, that is, it is preferable that the lower side of the main body 121 is accommodated in the reaction vessel 123 .
  • the reaction inducing unit 130 is built in the lower side of the body 121 and a solution capsule 132 in which the reaction solution is accommodated, and the upper and lower caps (131u, 131d) further comprising Embodiments of the structure may be applied.
  • the upper cap 131u constitutes the stopper 131, has an upper surface in contact with the lower surface of the cotton 111 for collection, is coupled to the lower end of the first rod 112a, and seals the upper portion of the solution capsule 132 will do
  • the lower cap 131d constitutes the stopper 131, is disposed on the lower surface of the solution capsule 132, and passes through the upper cap 131u according to the descending and rising of the first rod 112a. It engages with the lower end of 112a) to open the lower surface of the solution capsule 132.
  • the LFA cartridge 120 may further include a guide channel 124 passing through the center of the main body 121 as shown in FIG. 3 and having an inner surface corresponding to the outer surface shape of the handle 113 .
  • the center of the guide channel 124, the first rod 112a, and the lower cap 131d is arranged on a straight line as shown in the dashed-dotted line in FIG. 3, the lower end of the first rod 112a and the lower cap 131d ) is necessary for the precise positional combination of
  • the upper cap 131u is basically fixed to the first rod 112a by the male thread 115, and is rotated and pulled out from the lower end of the first rod 112a when collecting a sample including saliva. It can be said that it is disposable and discarded.
  • the lower cap 131d is made of a material such as elastic rubber, synthetic rubber, and synthetic resin and is engaged with the male thread 115 and then as the first rod 112a rises from the lower surface of the solution capsule 132 . It is separated so that the reaction solution flows out into the reaction vessel (123).
  • reaction inducing part 130 is formed in the center of the upper surface of the lower cap 131d, and rotates and descends while further comprising a fastening groove (not shown) having an inner circumferential surface with a female thread that engages with the male thread 115.
  • the lower end male thread 115 of the first rod 112a is in the form of a bolt, and the first rod 112a descends into the solution capsule 132 and moves to the upper surface of the lower cap 131d. After that, if the lower cap (131d) is engaged with the fastening groove of the lower cap (131d) to continue to rotate and descend.
  • the lower cap 131d opens the lower surface of the solution capsule 132 , and the reaction solution from which the sample is eluted flows into the reaction vessel 123 .
  • the cotton 111 for collection is contracted in the process of being fixed to the lower cap 131d according to the screw rotation, the sample including saliva is effectively eluted to the reaction solution side, and reaches the bottom dead center and automatically rises again.
  • the measuring device to be described later continues to rise after repeatedly raising and lowering the first rod 112a several times.
  • the reaction solution is more uniformly mixed with the sample, and the reaction with the strip 122 for LFA can be induced to be reliably made.
  • the measuring device 200 again with reference to FIG. 4 together with FIG. 1, a polygonal column-shaped body 121 and a reaction vessel 123 that accommodates the lower portion of the main body 121 and accommodates the reaction solution. It may include a measurement housing 210 having an internal space that can accommodate the LFA cartridge 120 including the.
  • the measurement housing 210 may further include an indicator 211 capable of displaying the current analysis progress.
  • Indicator 211 for example, 'Mixing', 'Binding', 'Analyzing', 'Finishing', etc., step by step, so that the measurer can grasp the current progress, the corresponding part is turned on in a bar shape with an LED.
  • Various applications and deformation designs are available. Of course it is possible.
  • the measurement housing 210 may further include a wired charging terminal 212 for connection with an external power source or various power sources for stable power supply.
  • the measuring device 200 includes a drive transmission unit 220 that generates a driving force for rotating the joint head 260 and the docking station 270 forward or backward, or raising or lowering the joint head 260 . can do.
  • the joint head 260 has a lower surface provided with a fixing member 250 that is detachably coupled to the upper end of the first rod 112a.
  • the docking station 270 is built in the measurement housing 210 so that the LFA cartridge 120 is mounted so that it can rotate forward and reverse.
  • the measuring device 200 is mounted on one side of the measuring housing 210 and reacted to the LFA strip 122 provided on the lower side of the plurality of reaction surfaces 121r provided in the vertical direction of the main body 121 .
  • a camera 230 for photographing the test line 301 formed by the reaction solution may be included.
  • the camera 230 may further include a light source 231 such as a flash to obtain a clean and clear image.
  • a light source 231 such as a flash to obtain a clean and clear image.
  • the camera 230 may be a CMOS or CCD camera, but is not limited thereto.
  • the measuring device 200 may include a processing unit 240 for calculating the concentration of the target material in the sample by comparing and analyzing the reaction determination data stored in the test line 301 photographed by the camera 230 .
  • the measuring device 200 is provided on one side of the measuring housing 210, is electrically connected to the drive transmission unit 220, the camera 230, and the processing unit 240, the pre-stored reaction determination data and the test line (
  • the controller 280 including the image processor 281 for calculating the color development ratio of 301 may be further provided.
  • the measuring device 200 is provided on one side of the measuring housing 210, is electrically connected to the controller 280, and further includes a start switch 282 for controlling the on/off of the power and the operation of the controller 280. may be provided.
  • the measurement device 200 is provided on one side of the measurement housing 210, is electrically connected to the start switch 282 and the controller 280, and outputs an analysis result through the image processor 281 (display panel ( 290) may be further provided.
  • the drive transmission unit 220 is provided on the upper side of the measurement housing 210 and is connected to the joint head 260 to rotate the first motor 221 and the joint head 260 . ) and may include a second motor 222 for raising or lowering the joint head 260 by being connected.
  • the drive transmission unit 220 is provided on one side of the measurement housing 210 , is connected to the docking station 270 , and rotates the polygonal column-shaped body 121 seated in the docking station 270 by a predetermined angle. It may include a third motor 223 for generating a driving force to stop and stop.
  • the lower cap 131d of the reaction inducing unit 130 as described above is connected to the lower end of the first rod 112a.
  • the reaction solution in the solution capsule 132 is more uniformly mixed with the sample to reliably react with the LFA strip 122 .
  • the above-described predetermined angle is a pattern in which n response surfaces 121r of the main body 121 having a polygonal column shape are rotated and stopped by 360/n degrees to face the camera 230 provided in the measurement housing 210, n -1 or n repetitions.
  • n is a positive integer of 3 or more.
  • the main body 121 has a quadrangular pole shape
  • the pattern of rotating and stopping by 360/4, that is, 90 degrees so that the four response surfaces 121r face the camera 230 can be repeated 3 or 4 times.
  • the measurement housing 210 may further include a power button 283 capable of turning on/off the power of the entire device together with the start switch 282 as shown in FIG. 5 unlike FIGS. 1 to 4 .
  • the measurement housing 210 may include a wired charging terminal 212 capable of supplying power through a USB cable together with the function of a wired charging terminal.
  • one side of the measurement housing 210 may further include a display panel 290 as shown in FIG. 5 as in the embodiment of FIGS. 1 to 4 , and the test mentioned in the embodiment of FIGS. 1 to 4 .
  • the line 301 and the control line 302 to be described later are displayed only in the form of a line, in the present embodiment, the test line and the control line may be displayed in the above-described line form, as well as being displayed in various forms as follows. can
  • any shape and shape that can enhance visual recognition such as a spot, pixel, dot shape, along with the aforementioned line shape, is applied. You can do it.
  • the color developing material of the lines, spots, pixels, and dots of the test line and the control line described above is gold (Au), quantum dots, colored glass or colored plastic beads, fluorescent materials, enzymes, enzymatic reactions or non-enzymatic reactions.
  • Au gold
  • quantum dots colored glass or colored plastic beads
  • fluorescent materials fluorescent materials
  • enzymes enzymes
  • enzymatic reactions non-enzymatic reactions.
  • it may be any one or a combination of at least one or more selected from the group consisting of a chromogenic substrate used for
  • the present invention may be applied to an embodiment of the structure using the cotton swab 116 instead of the first rod 112a as shown in FIGS. 5 to 10 .
  • the sample collection unit 110 may further include a cotton swab 116 having a lower end to which the cotton collection 111 is mounted.
  • the reaction inducing unit 130 is a second rod (112b) having a lower end accommodated in the reaction vessel 123 and an upper end coupled to the fixing member 250 of the measuring device when viewed with reference to FIGS. 5 to 7, It is mounted on the lower side of the second rod 112b and may further include a first impeller 133a for stirring the reaction solution so that the sample discharged from the cotton 111 for collection reacts with the reaction solution.
  • a rod hole 121a through which the second rod 112b can enter and exit, and a first input hole ( 121b) may be further provided.
  • the drive transmission unit 220 is shown with reference to FIGS. 5 to 7 , the first, second, and third motors 221 , together with the fixing member 250 (refer to the structure of FIGS. 222, 223) may be further provided.
  • the fixing member 250 is detachably coupled to the upper end of the second rod 112b.
  • the joint head 260 has a lower surface provided with a fixing member 250 .
  • the first motor 221 is provided on the upper side of the measurement housing 210 and is connected to the joint head 260 to rotate the joint head 260 .
  • the second motor 222 is connected to the joint head 260 to raise or lower the joint head 260 .
  • the third motor 223 is provided on one side of the measurement housing 210, is connected to the docking station 270, and rotates and stops the polygonal column-shaped body 121 seated in the docking station 270 by a predetermined angle. to generate driving force.
  • the first motor 221 may grasp that the first impeller 133a mounted on the lower side of the second rod 112b rotates.
  • the above-described predetermined angle is a pattern in which n response surfaces 121r of the main body 121 having a polygonal column shape are rotated and stopped by 360/n degrees to face the camera 230 provided in the measurement housing 210, n -1 or n repetitions.
  • n is a positive integer of 3 or more.
  • the main body 121 has a quadrangular pole shape
  • the pattern of rotating and stopping by 360/4, that is, 90 degrees so that the four response surfaces 121r face the camera 230 can be repeated 3 or 4 times.
  • the reaction inducing unit 130 may further include a stopper 131 capable of opening and closing the upper surface of the reaction vessel 123 , referring to FIGS. 8 to 10 .
  • reaction inducing unit 130 may further include a second impeller 133b mounted on the upper side of the stopper 131 to stir the reaction solution so that the sample discharged from the cotton 111 for collection reacts with the reaction solution. There will be.
  • reaction inducing unit 130 may further include a third rod 134 having both upper and lower ends connected to the stopper 131 and the bottom surface of the reaction vessel 123 .
  • the stopper 131 is rotated upward or rotated together with the reaction vessel 123 as shown in FIG. 8(b) by the drive transmission unit 220 including the docking station 270 on which the reaction vessel 123 is seated. While descending, the upper surface of the reaction vessel 123 will be opened and closed.
  • a second input hole 121c may be further provided on the upper surface of the main body 121 so that a saliva buffer or a cotton swab 116 can be inserted as shown in FIG. 9( a ).
  • the main body 121 may further include a collection guide hopper 118 formed in a funnel shape as shown in FIG. 10 .
  • the collection guide hopper 118 is provided to prevent the solution from jumping out of the body 121 during high-speed rotation when extracting a sample from the cotton 111 for collection of the cotton swab 116 .
  • the collection guide hopper 118 is required, when the cotton 111 for collection is inserted into the body 121, and in the state in which the cotton 111 for collection is inserted into the body 121 (b)
  • the stopper 131 is opened and the cotton swab 116 containing the cotton 111 for collection is lifted as shown, the sample is removed from the cotton 111 for collection in contact with the lower end of the funnel, that is, the lower portion of the collection guide hopper 118. This is because it can achieve a squeezing effect.
  • sample extraction efficiency can be improved by squeezing the sample from the cotton 111 for collection, and when the sample extraction efficiency is increased, the detection reaction time can be shortened.
  • the drive transmission unit 220 may further include a fourth motor 224 and a fifth motor 225 , referring to FIGS. 8 and 9 .
  • the fourth motor 224 is provided on one side of the measurement housing 210, is connected to the docking station 270, and rotates the circular or polygonal pole-shaped body 121 seated on the docking station 270 by a predetermined angle. It stops and generates a driving force capable of forward and reverse rotation.
  • the fourth motor is connected to the lower end of the third rod 112c in the third rod 112c that extends to the stopper 131 that can open and close the upper surface of the reaction vessel 123 and is accommodated in the reaction vessel 123 . It will also be able to perform a role of forward and reverse rotation of the third rod (112c).
  • the fifth motor 225 serves to generate a driving force for raising or lowering the body 121 seated in the docking station 270 .
  • the fourth motor 224 may grasp that the second impeller 133b mounted on the upper side of the stopper 131 rotates.
  • the above-described predetermined angle is a pattern in which the n response surfaces 121r of the main body 121 having a circular or polygonal column shape rotate and stop by 360/n degrees to face the camera 230 provided in the measurement housing 210 . may be repeated n-1 times or n times.
  • n is a positive integer of 3 or more.
  • the main body 121 has a circular or polygonal prism shape
  • the pattern of rotating and stopping by 360/4, that is, 90 degrees so that the four response surfaces 121r face the camera 230 is performed three or four times can be repeated.
  • FIGS. 11 and 12 For reference, reference numerals not indicated in FIGS. 11 and 12 refer to FIGS. 1 to 10 .
  • a sample including saliva is collected in the oral cavity of the subject to be measured with the cotton 111 for collection mounted on the lower end of the first rod 112a (S1: first step).
  • the first rod 112a is pushed into the LFA cartridge 120 seated in the measurement housing 210 as shown in FIG. , the sample is eluted in the reaction solution in the LFA cartridge 120 (S2: second step).
  • the rod 112 is further lowered into the LFA cartridge 120 as shown in FIG.
  • the stopper 131 is opened to bring the reaction solution into contact with the plurality of LFA strips 122 (S3: third step).
  • the LFA cartridge 120 is rotated and stopped so that the plurality of reaction surfaces 121r face the camera 230 provided in the measurement housing 210 after a second time period greater than the first time has elapsed to stop the LFA strip ( 122), the control line 302 and the test line 301 are photographed by the camera 230 (S4: fourth step).
  • the image processor 281 compares and analyzes the image captured by the camera 230 with the reaction determination data stored in the color ratio between the control line 302 and the test line 301 to calculate the concentration of the target substance in the sample. and output the calculation result through the display panel 290 formed on one side of the measurement housing 210 (S5: fifth step).
  • the first time is 0.1 seconds to 5 minutes, and the second time may be appropriately adjusted within 1 second to 15 minutes.
  • the second motor 222 raises or lowers the handle 113 connected to the fixing member 250 and the coupling groove 113g as shown in FIG.
  • the LFA (Lateral Flow Immuno Assay) strip automatic analysis apparatus includes an LFA kit including a saliva collection swab and a reaction solvent, a measurement and analysis device, and a wired charger.
  • the LFA strip automatic analysis apparatus In the LFA (Lateral Flow Immuno Assay) strip automatic analysis apparatus according to the present invention, data on the color development ratio of the control line and the test line for each concentration is stored using the sample for each concentration of the target material in determining the LFA strip reaction, and the target Due to the reaction of the LFA strip with the sample whose concentration is unknown, the color development ratio of the control line and the test line is photographed through a camera (eg, CMOS or CCD camera) and calculated through image processing. The concentration of the target substance in it is calculated and displayed.
  • a camera eg, CMOS or CCD camera
  • the LFA (Lateral Flow Immuno Assay) strip automatic analysis device 1) After collecting saliva, a cotton swab is inserted into the LFA kit, mounted on the measuring device, and when the “Start” button is pressed, the reaction and analysis are performed automatically and the result is confirmed 2) saliva on the cotton swab is effectively eluted and mixed with the reaction solvent and can be used continuously as long as there is no device failure, the analysis kit is a consumable, 5) the measuring device includes a drive transmission unit to drive the LFA cartridge, 6) the camera (e.g., CMOS or CCD camera) and flash are installed, and 7) the back side of the measuring device has an analysis result confirmation window and an instrument panel to check the progress.
  • the analysis kit is a consumable
  • the LFA strip cartridge was configured to mount two LFA strips on each side as a square face.
  • the LFA strip cartridge has a swab for collecting the sample inside, and when the swab for collecting the sample is inserted from the top down, the upper layer of the reaction solution container surrounded by the inner membrane is pierced and the sample is placed on the swab.
  • the attached sample is dissolved in the reaction solution, and after a certain period of time, if you push the handle of the cotton swab from top to bottom once more, the membrane on the lower layer of the reaction solution container is pierced and the reaction solution in which the sample is dissolved flows out into the container at the bottom of the cartridge and the LFA strip installed designed to react with
  • the sample collection part had a handle and was composed of a cotton swab structure with a pointed tip.
  • the sampling part was made in a pointed shape so that it could easily penetrate the upper and lower layers of the reaction solution container inside the cartridge.
  • the camera for analysis consisted of a light source and a CCD camera to photograph the color development of the control line and test line of the LFA strip.
  • the kit mounting part and rotation driving part consisted of an LFA strip cartridge mounting part and a rotating part that the cartridge can rotate.
  • the kit mounting part and rotation driving part were made to automatically rotate one side after a certain period of time after the reaction of the sample and the LFA strip so that the camera can photograph the LFA strip located on each side of the quadrangular plane.
  • the control unit is composed of a board that controls the CCD camera, light source, rotation unit, LCD window, power supply and progress indicator.
  • the control unit is designed to enable image processing to obtain the color ratio between the control line and the test line.
  • the power supply and observation part are composed of power button, LCD window and progress indicator.
  • the cotton swab moves into the solvent container and moves up and down several times, and as the cotton swab rotates, it is fixed with the lower stopper. There was a hole in the pit, and the mixed solution flowed out into the reaction vessel.
  • the solution is applied to the LFA kit strip and the reaction is performed, and the reaction result is displayed as a line on the membrane.
  • the camera of the device takes the membrane to obtain an image. After shooting 4 sides, the results of the lines from each side were analyzed and the reaction results were displayed in the result window.
  • the image processor digitizes the color development ratio of the control line and the test line in the captured image and compares the color development ratio of the existing control line/test line to find the concentration of the target substance in the sample, and the target concentration appears on the LCD window ended
  • the present invention has a basic technical idea to provide a fully automatic lateral flow immunoassay kit and measuring device for the measurement of multiple biomarkers in saliva capable of detecting various target substances.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Cell Biology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

La présente invention concerne un appareil d'analyse automatique de bandelette de dosage immunologique à écoulement latéral entièrement automatique pour la mesure de multiples biomarqueurs issus de la salive, l'appareil comprenant un dispositif de mesure et un kit de dosage immunologique à écoulement latéral (ci-après, LFA) kit, qui est un kit de LFA. L'appareil d'analyse automatique de bandelette de dosage immunologique à écoulement latéral selon la présente invention possède, en lien avec une détermination de réaction de bandelette de LFA, des données stockées concernant le rapport de coloration entre une ligne d'essai et une ligne témoin par rapport à chaque concentration en utilisant un échantillon pour chaque concentration de substance cible. Lorsque le rapport de coloration entre une ligne d'essai et une ligne témoin est imagé par l'intermédiaire d'un appareil de prise de vues en conséquence d'une réaction entre un échantillon ayant une concentration de substance cible inconnue et une bandelette de LFA, et calculé par l'intermédiaire d'un traitement d'image, celui-ci est comparé à des données existantes de telle sorte que la concentration de la substance cible dans l'échantillon soit calculée et affichée, ce qui permet une analyse rapide, hautement reproductible et hautement sensible.
PCT/KR2020/016121 2020-03-03 2020-11-17 Kit de dosage immunologique à écoulement latéral entièrement automatique et dispositif de mesure pour la mesure de multiples biomarqueurs de la salive WO2021177548A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020200026363A KR102156569B1 (ko) 2020-03-03 2020-03-03 타액의 다중 바이오마커 측정을 위한 전자동 측면유동면역분석 키트 및 측정기기
KR10-2020-0026363 2020-03-03

Publications (1)

Publication Number Publication Date
WO2021177548A1 true WO2021177548A1 (fr) 2021-09-10

Family

ID=72669728

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2020/016121 WO2021177548A1 (fr) 2020-03-03 2020-11-17 Kit de dosage immunologique à écoulement latéral entièrement automatique et dispositif de mesure pour la mesure de multiples biomarqueurs de la salive

Country Status (2)

Country Link
KR (1) KR102156569B1 (fr)
WO (1) WO2021177548A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022223555A1 (fr) * 2021-04-23 2022-10-27 SOLIOS DIAGNOSTICS GmbH Dispositif de test, procédé de test et procédé de fabrication d'un dispositif de test pour la mise en oeuvre d'un test portant sur la détection d'une structure organique

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102156569B1 (ko) * 2020-03-03 2020-09-16 주식회사 이바이오젠 타액의 다중 바이오마커 측정을 위한 전자동 측면유동면역분석 키트 및 측정기기
KR102623055B1 (ko) 2021-12-23 2024-01-08 동신대학교산학협력단 Lfa 인식 장치 및 시스템
KR102629904B1 (ko) 2022-03-21 2024-01-30 주식회사 켈스 머신러닝과 이미지 프로세싱을 이용한 진단 키트 영상의 위치 및 색상 보정 장치 및 방법

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080076169A1 (en) * 2006-09-26 2008-03-27 The Regents Of The University Of California Lateral flow strip assay
US20080090305A1 (en) * 2006-10-11 2008-04-17 Day Alan R Device for detection of molecules in biological fluids
KR102156569B1 (ko) * 2020-03-03 2020-09-16 주식회사 이바이오젠 타액의 다중 바이오마커 측정을 위한 전자동 측면유동면역분석 키트 및 측정기기

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100930517B1 (ko) 2009-07-01 2009-12-09 (주)휴벳 소의 임신 진단용 키트 및 이를 이용한 임신 진단방법

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080076169A1 (en) * 2006-09-26 2008-03-27 The Regents Of The University Of California Lateral flow strip assay
US20080090305A1 (en) * 2006-10-11 2008-04-17 Day Alan R Device for detection of molecules in biological fluids
KR102156569B1 (ko) * 2020-03-03 2020-09-16 주식회사 이바이오젠 타액의 다중 바이오마커 측정을 위한 전자동 측면유동면역분석 키트 및 측정기기

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
ADRIAN CARRIO, CARLOS SAMPEDRO, JOSE SANCHEZ-LOPEZ, MIGUEL PIMIENTA, PASCUAL CAMPOY: "Automated Low-Cost Smartphone-Based Lateral Flow Saliva Test Reader for Drugs-of-Abuse Detection", SENSORS, vol. 15, no. 12, pages 29569 - 29593, XP055257628, DOI: 10.3390/s151129569 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022223555A1 (fr) * 2021-04-23 2022-10-27 SOLIOS DIAGNOSTICS GmbH Dispositif de test, procédé de test et procédé de fabrication d'un dispositif de test pour la mise en oeuvre d'un test portant sur la détection d'une structure organique

Also Published As

Publication number Publication date
KR102156569B1 (ko) 2020-09-16

Similar Documents

Publication Publication Date Title
WO2021177548A1 (fr) Kit de dosage immunologique à écoulement latéral entièrement automatique et dispositif de mesure pour la mesure de multiples biomarqueurs de la salive
WO2018143680A1 (fr) Appareil d'immunoessai en phase liquide automatisé
WO2013041004A1 (fr) Dispositif de test pour des examens médicaux
WO2016182382A1 (fr) Poste, utilisé pour un appareil de test, ayant un moyen de réaction et de détection intégré
WO2021025458A1 (fr) Dispositif pour analyser un kit de diagnostic in vitro mobile utilisant des informations multimédia
JPS6472540A (en) Radiation microscope and method for detecting light emitted from defect in dielectric layer of integrated circuit device
WO2019107666A1 (fr) Bandelette de test d'urine comprenant un minuteur et méthode de détection et d'analyse de bandelette de test d'urine
WO2018084337A1 (fr) Procédé de mesure du ratio d'hémoglobine glyquée
WO2018097585A1 (fr) Unité d'échantillon pour dispositif d'essai de fluide corporel, et dispositif d'essai de fluide corporel comprenant celle-ci
WO2018062587A1 (fr) Cassette séparable permettant de mesurer l'hémoglobine glyquée
WO2015190660A1 (fr) Dispositif automatique de test de l'acuité visuelle et procédé automatique de test de l'acuité visuelle
WO2020096292A1 (fr) Cartouche d'appareil d'analyse pour diagnostic in vitro
JP2532272B2 (ja) 引張試験装置
WO2015072757A1 (fr) Station destinée à un dispositif d'essai équipée d'un moyen de réaction et de détection intégré
WO2022114530A1 (fr) Cartouche de diagnostic pour diagnostic immunitaire, et lecteur et système de diagnostic l'utilisant
WO2020197193A1 (fr) Dispositif et procédé de dosage immunologique
WO2021045359A2 (fr) Testeur de liquide organique
WO2021066540A1 (fr) Dispositif d'analyse de fluide corporel et procédé d'analyse de fluide corporel l'utilisant
WO2019132199A1 (fr) Unité de diagnostic, dispositif de diagnostic et procédé de diagnostic
WO2018043779A1 (fr) Cassette intégrée pour la mesure de l'hémoglobine glyquée
JP2000028482A (ja) 液晶パネル評価装置
WO2020235964A1 (fr) Appareil de diagnostic pour immunoessai
WO2010143799A1 (fr) Système d'analyse de matériau portatif
JPS63317739A (ja) 引張試験装置
KR960024435A (ko) 티에프티 엘씨디 모듈(tft-lcd module)의 탭(tab) 자동 검사 장치

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 20923278

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

32PN Ep: public notification in the ep bulletin as address of the adressee cannot be established

Free format text: NOTING OF LOSS OF RIGHTS PURSUANT TO RULE 112(1) EPC

122 Ep: pct application non-entry in european phase

Ref document number: 20923278

Country of ref document: EP

Kind code of ref document: A1