WO2020235964A1 - Appareil de diagnostic pour immunoessai - Google Patents

Appareil de diagnostic pour immunoessai Download PDF

Info

Publication number
WO2020235964A1
WO2020235964A1 PCT/KR2020/006709 KR2020006709W WO2020235964A1 WO 2020235964 A1 WO2020235964 A1 WO 2020235964A1 KR 2020006709 W KR2020006709 W KR 2020006709W WO 2020235964 A1 WO2020235964 A1 WO 2020235964A1
Authority
WO
WIPO (PCT)
Prior art keywords
light
mask
slit
sample strip
slit portion
Prior art date
Application number
PCT/KR2020/006709
Other languages
English (en)
Korean (ko)
Inventor
김희준
김성준
Original Assignee
프리시젼바이오 주식회사
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
Priority claimed from KR1020190060479A external-priority patent/KR102273586B1/ko
Priority claimed from KR1020190060498A external-priority patent/KR102273588B1/ko
Priority claimed from KR1020190060497A external-priority patent/KR102273587B1/ko
Application filed by 프리시젼바이오 주식회사 filed Critical 프리시젼바이오 주식회사
Publication of WO2020235964A1 publication Critical patent/WO2020235964A1/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
    • 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
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/62—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
    • G01N21/63—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
    • G01N21/64—Fluorescence; Phosphorescence
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • 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
    • G01N33/58—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances

Definitions

  • the present invention relates to an immunoassay diagnostic device. More specifically, by simply disposing a mask with a slit part and changing the position of the slit part without separate movement of the sample strip or the optical module, the test light can be accurately irradiated to the reaction area of the sample strip, and from the reaction area of the sample strip.
  • the present invention relates to an immunoassay diagnostic apparatus capable of accurately detecting generated fluorescence or reflected light, thereby improving diagnostic accuracy and ease of use.
  • the test method used for disease diagnosis is mainly based on color development and fluorescence by an enzymatic reaction, but recently, a method using an immunoassay using an immune reaction between an antigen and an antibody is also used.
  • This immunoassay method mainly uses a labeled biosensor that can detect the presence or absence of an antigen by labeling an antibody with a radioactive isotope or fluorescent substance, and quantify it by the intensity of radiation or fluorescence.
  • ELISA Enzyme Linked Immunosorbent Assay
  • the immune sensor Since antibodies, which are the target substances of the immune sensor, are present in very low concentrations in biological samples such as whole blood, serum, and urine, the immune sensor is more suitable than a biosensor technology that detects other substances. It is necessary to have a highly sensitive signaling technology that is far superior in the detection limit of In addition, since the structure of proteins such as antibodies, protein antigens, and the like easily changes due to changes in the external environment, the recognition site of the antigen or antibody is likely to deteriorate, and the inherent biometric function is likely to be lost.
  • the rapid diagnostic test kit for immunoassay is a test tool for point-of-care that enables diagnostic tests using biological samples such as blood, urine, and saliva.
  • Examples of such rapid diagnostic test kits include pregnancy diagnostic kits and AIDS diagnostic kits.
  • Such a diagnostic device must establish a method capable of detecting a predetermined biological material (protein or DNA, etc.) for diagnosis.
  • a fluorescent labeling method using organic dyes is known, but this is a relatively more complex structure such as a separate fluorescence detection means for detecting fluorescence, a fluorescent material and a separate light source for generating fluorescence.
  • a method of simply detecting reflected light reflected from a biological material is also widely used, and this has the advantage of relatively simple configuration.
  • Such an immunoassay diagnostic device operates in the same principle as the fluorescence method or the reflected light method, and uses a sample strip capable of adsorbing and supplying a biological sample through a capillary phenomenon. A plurality of reaction regions to which a separate reaction substance is attached, respectively, are formed in the sample strip.
  • each reactive substance is combined with a biological sample having a specific disease in a plurality of reaction regions to form a fluorescent reaction complex, and the fluorescent reaction complex generates fluorescence when light is irradiated.
  • the fluorescent reaction complex generates fluorescence when light is irradiated.
  • the reflected light method in a plurality of reaction regions, each reactive substance is combined with a biological sample having a specific disease to form a light reflective complex, and the light reflective complex receives light and reflects it. Therefore, after inserting the sample strip into the device, by irradiating the test light onto the sample strip from a light source, and detecting fluorescence or reflected light generated from the reaction area of the sample strip through an optical system, it is possible to diagnose a specific disease on a biological sample. have.
  • the present invention has been invented to solve the problems of the prior art, and an object of the present invention is to arrange a separate mask with a slit portion formed thereon, and to adjust the position of the slit portion of the mask by an electrical signal, a separate mechanical driving unit In addition to being able to adjust the position of the slit without the need, it is possible to variously change the irradiation position of the inspection light through the adjustment of the position of the slit, the position of the slit can be adjusted quickly and conveniently, and product miniaturization and production cost reduction are possible. It is to provide an analysis diagnostic device.
  • Another object of the present invention is to apply a liquid crystal module to a mask so that the position of the slit can be quickly and variously adjusted by an electrical signal, and accordingly, an immunoassay that can be applied to all types of sample strips through one device. It is to provide a diagnostic device.
  • Another object of the present invention is to control the position of the slit portion of the mask to scan the entire area of the sample strip, so that the inspection light can be irradiated in the form of scanning the entire area of the sample strip without a separate mechanical driving unit. It is to provide an immunoassay diagnostic device capable of analyzing and diagnosing a disease of a biological sample in a rapid manner.
  • Another object of the present invention is to simply place a mask with a slit portion and change the position of the slit portion without separate movement of a sample strip or an optical module, thereby enabling accurate irradiation of inspection light and accurate detection of fluorescence, thereby improving diagnostic accuracy and ease of use. It is to provide an immunoassay diagnostic device that can be improved.
  • Another object of the present invention is to selectively open and close the slit formed in the mask, so that the position of the slit is controlled without moving the mask, so that the irradiation position of the inspection light and the fluorescence can be detected more accurately, and the structure is constructed without a complicated mechanical driving unit. It is to provide an immunoassay diagnostic device that can be simplified and easily manufactured and can be miniaturized.
  • Another object of the present invention is to arrange a separate mask with a slit portion formed thereon, and to adjust the shape and size of the slit portion of the mask by an electrical signal, so that other reflected light other than the reflected light reflected from the light reflection composite of the actual sample strip
  • the present invention provides an immunoassay diagnostic apparatus capable of improving the overall diagnostic accuracy by preventing passing through, thereby improving the detection accuracy of reflected light.
  • Another object of the present invention is to enable the position control along with the shape and size control of the slit part of the mask, so that the shape, size and position of the slit part can be quickly and variously adjusted by an electrical signal, and a separate mechanical Since the position of the slit part can be adjusted without a driving part, it is possible to conveniently and quickly change the irradiation position of the inspection light, thereby reducing product size and production cost, and can be applied to all types of sample strips through one device. It is to provide an immunoassay diagnostic device that expands the scope of use.
  • Another object of the present invention is to monitor the intensity of the inspection light generated from the light source unit through a separate auxiliary light-receiving sensor to keep the intensity of the inspection light constant, so that changes in the intensity of fluorescence or reflected light generated from the sample strip can be accurately recognized. It is to provide an immunoassay diagnostic device capable of further improving diagnostic accuracy.
  • the present invention includes: a sample strip having a plurality of reaction regions each of which a separate reaction material is applied to form a fluorescent reaction complex by reacting with the supplied sample and reacting with the supplied sample; An optical module for irradiating a test light onto the sample strip to generate fluorescence from the fluorescent reaction complex of the sample strip; A main light-receiving sensor that receives and detects fluorescence generated from the fluorescent reaction complex of the sample strip by irradiation of the test light; Blocking the inspection light of the optical module, a slit portion through which the inspection light can pass is formed in a partial area to guide the irradiation position of the inspection light to the sample strip through the slit portion, and the slit portion within the mask area A mask formed to adjust a formation position; And a mask control unit for controlling the operation of the mask so that the formation position of the slit part is adjusted, wherein the mask is operated and controlled by the mask control unit so that the test light is selectively irradiated to a plurality of reaction
  • the mask may be formed to adjust the formation position of the slit part by an electric signal.
  • the mask control unit may control the operation so that the formation position of the slit part continuously moves within the area of the mask so that the inspection light is irradiated while scanning a specific area of the sample strip.
  • the mask control unit may control the operation so that the slit portions are sequentially formed at positions corresponding to the plurality of reaction regions of the sample strip.
  • the mask may include a mask case formed of a transparent material to pass the inspection light and fluorescence; And a liquid crystal module disposed in the inner space of the mask case and including a liquid crystal configured to change an arrangement state by an electrical signal to pass or block light, wherein the liquid crystal arrangement state of the liquid crystal module by an electrical signal It may be formed to enable the formation of the slit portion and the formation position of the slit portion through adjustment.
  • the present invention includes: a sample strip having a plurality of reaction regions each of which a separate reaction material is applied to form a fluorescent reaction complex by reacting with the supplied sample and reacting with the supplied sample; An optical module for irradiating a test light onto the sample strip to generate fluorescence from the fluorescent reaction complex of the sample strip; A main light-receiving sensor that receives and detects fluorescence generated from the fluorescent reaction complex of the sample strip by irradiation of the test light; It is formed of a material that blocks light, and a slit through which light can pass is formed in a partial region to guide the light-receiving path of the fluorescence generated from the plurality of reaction regions of the sample strip through the slit part, and the slit part within the mask region A mask formed to adjust a formation position; And a mask control unit for controlling the operation of the mask so that the formation position of the slit part is adjusted, wherein the mask is operated by the mask control unit so that fluorescence generated from a plurality of reaction
  • the present invention includes: a sample strip having a plurality of reaction regions each of which a separate reaction material is applied to form a fluorescent reaction complex by reacting with the supplied sample and reacting with the supplied sample; An optical module for irradiating a test light onto the sample strip to generate fluorescence from the fluorescent reaction complex of the sample strip; A main light-receiving sensor that receives and detects fluorescence generated from the fluorescent reaction complex of the sample strip by irradiation of the test light; A mask formed of a material that blocks the inspection light of the optical module, a slit portion through which the inspection light passes through a partial region, and guides the irradiation position of the inspection light to the specimen strip through the slit portion; And a slit part position adjusting means for adjusting the position of the slit part, wherein the position of the slit part is adjusted by the slit part position adjusting means so that the test light is selectively irradiated to a plurality of reaction regions of the sample strip. It provides an immuno
  • one slit part may be formed on one side of the mask, and the slit part position adjusting means may be configured to adjust the position of the slit part by moving the mask.
  • the slit portion position adjusting means may include an operation member coupled with the mask to move the mask in a direction perpendicular to the optical axis of the inspection light passing through the slit portion; And a mask driving unit operating the operation member to move the mask.
  • a plurality of the slit portions may be formed on the mask so as to be positioned to correspond to the reaction region, and the slit portion position adjusting means may be configured to adjust the position of the slit portion in a manner that sequentially opens the plurality of slit portions one by one. .
  • the slit portion position adjustment means a blocking plate capable of selectively closing a plurality of the slit portion; And a blocking plate driving unit operating the blocking plate so that the plurality of the slit units are sequentially opened one by one.
  • the present invention includes: a sample strip having a plurality of reaction regions each of which a separate reaction material is applied to form a fluorescent reaction complex by reacting with the supplied sample and reacting with the supplied sample; An optical module for irradiating a test light onto the sample strip to generate fluorescence from the fluorescent reaction complex of the sample strip; A main light-receiving sensor that receives and detects fluorescence generated from the fluorescent reaction complex of the sample strip by irradiation of the test light; A mask formed of a material that blocks light, and has a slit portion through which light passes through the slit portion to guide a light-receiving path of fluorescence generated from the plurality of reaction regions of the sample strip; And a slit part position adjusting means for adjusting a position of the slit part, wherein fluorescence generated from a plurality of reaction regions of the sample strip is selectively selected by the main light receiving sensor by adjusting the position of the slit part by the slit part position adjusting means It provides an immuno
  • the present invention comprises: a sample strip having a plurality of reaction regions each of which is formed so that a sample is adsorbed and supplied and to which a separate reactive material is applied to form a light reflective composite by reacting with the supplied sample; An optical module irradiating an inspection light onto the sample strip; A main light-receiving sensor configured to receive and detect reflected light reflected from the light-reflecting composite of the sample strip by irradiation of the inspection light; A mask that blocks the inspection light and reflected light, has a slit portion through which the inspection light and the reflected light can pass through a partial area, and is formed to adjust the formation position of the slit portion within the mask area; And a mask control unit for controlling the operation of the mask so that the formation position of the slit part is adjusted, wherein the mask is operated and controlled by the mask control unit so that the test light is selectively irradiated to a plurality of reaction regions of the sample strip. It provides an immunoassay diagnostic device, characterized in that the formation
  • the mask is formed to adjust the shape and size of the slit portion
  • the mask control unit may control the operation of the mask to adjust the shape or size of the slit portion.
  • the mask may include a mask case formed of a transparent material to pass the inspection light and the reflected light; And a liquid crystal module disposed in the inner space of the mask case and including a liquid crystal configured to change an arrangement state by an electrical signal to pass or block light, wherein the liquid crystal arrangement state of the liquid crystal module by an electrical signal
  • the slit portion may be formed and the position of the slit portion may be adjusted, and the shape and size of the slit portion may be adjusted.
  • the present invention comprises: a sample strip having a plurality of reaction regions each of which is formed so that a sample is adsorbed and supplied and to which a separate reactive material is applied to form a light reflective composite by reacting with the supplied sample; An optical module irradiating an inspection light onto the sample strip; A main light-receiving sensor configured to receive and detect reflected light reflected from the light-reflecting composite of the sample strip by irradiation of the inspection light; A mask formed of a material that blocks light, has a slit portion through which light can pass through a portion thereof, and is formed to adjust a position of the slit portion within the mask area; And a mask control unit for controlling the operation of the mask so that the formation position of the slit part is adjusted, wherein the mask is operated by the mask control unit so that reflected light reflected from the plurality of reaction regions of the sample strip is selectively selected from the main light receiving sensor. It provides an immunoassay diagnostic device, characterized in that the formation position of the slit is
  • the optical module the light source for generating the inspection light; And a lens module disposed so that the inspection light generated from the light source passes and the fluorescence or reflected light generated from the fluorescent reaction complex or the light reflective complex of the sample strip passes, wherein the main light-receiving sensor is a fluorescence reaction of the sample strip.
  • the fluorescent or reflected light generated from the composite or the light reflective composite is disposed to be received after passing through the lens module, and the mask includes a space between the lens module and the sample strip, a space between the lens module and the main light receiving sensor, and the lens It may be disposed at any one of the spaces between the plurality of lenses of the module.
  • the optical module may include a dichroic filter that partially reflects the inspection light generated from the light source and proceeds toward the sample strip; And an auxiliary light-receiving sensor for receiving and detecting some inspection light that has passed through the dichroic filter without being reflected by the dichroic filter among the inspection light generated from the light source unit, wherein the light source unit
  • the operation may be controlled by a separate light source control unit so that the intensity of the inspection light generated from the light source unit is adjusted according to the intensity of the inspection light detected by the light source.
  • the present invention by disposing a separate mask having a slit portion and allowing the position of the slit portion of the mask to be adjusted by an electrical signal, it is possible to adjust the position of the slit portion as well as the position of the slit portion without a separate mechanical driving unit. Through this, the irradiation position of the inspection light can be variously changed, the position of the slit can be adjusted quickly and conveniently, and the product can be miniaturized and the production cost can be reduced.
  • liquid crystal module By applying a liquid crystal module to the mask, it is possible to quickly and variously adjust the position of the slit portion by an electrical signal, and accordingly, it is possible to apply all of the various types of sample strips through one device.
  • the position of the slit part is adjusted without moving the mask, so that the irradiation position and fluorescence detection of the inspection light can be more accurately performed, and the structure can be simplified without a complicated mechanical driving part. There is an effect that this is easy and miniaturization is possible.
  • FIG. 1 is a conceptual diagram conceptually showing the basic structure of an immunoassay diagnostic apparatus according to an embodiment of the present invention
  • FIG. 2 is an enlarged view of a portion "A" shown in FIG. 1 based on the immunoassay diagnostic apparatus according to the first embodiment of the present invention
  • FIG. 3 is a diagram conceptually showing an arrangement state of a sample strip and a mask of the immunoassay diagnostic apparatus according to the first embodiment of the present invention
  • FIG. 6 is a functional block diagram functionally showing the configuration of an immunoassay diagnostic apparatus according to the first and third embodiments of the present invention.
  • FIG. 7 is an enlarged view of a portion "A" shown in FIG. 1 based on an immunoassay diagnostic apparatus according to a second embodiment of the present invention
  • FIG. 8 is a diagram conceptually showing an arrangement state of a sample strip and a mask of the immunoassay diagnostic apparatus according to the second embodiment of the present invention.
  • FIGS. 9 and 10 are diagrams schematically showing a state in which the position of the slit is adjusted through the slit position adjusting means of the immunoassay diagnostic apparatus according to the second embodiment of the present invention.
  • FIG. 11 is an enlarged view of a portion "A" shown in FIG. 1 based on an immunoassay diagnostic apparatus according to a third embodiment of the present invention
  • FIG. 12 is a diagram conceptually showing sizes and arrangements of sample strips and masks of the immunoassay diagnostic apparatus according to a third embodiment of the present invention.
  • FIG. 13 is a diagram illustrating a state of changing the size of a slit portion of a mask of the immunoassay diagnostic apparatus according to a third embodiment of the present invention.
  • FIGS. 14 and 15 are diagrams conceptually showing a configuration of an optical module of an immunoassay diagnostic apparatus according to an embodiment of the present invention.
  • 16 is a diagram illustrating an arrangement state of a mask according to an embodiment of the present invention.
  • FIG. 1 is a conceptual diagram conceptually showing the basic structure of an immunoassay diagnostic apparatus according to an embodiment of the present invention
  • FIG. 2 is a diagram shown in FIG. 1 based on the immunoassay diagnosis apparatus according to the first embodiment of the present invention
  • FIG. 3 is an enlarged view of a portion "A”
  • FIG. 3 is a diagram conceptually showing an arrangement state of a sample strip and a mask of the immunoassay diagnostic apparatus according to the first embodiment of the present invention
  • FIGS. 4 and 5 are An exemplary diagram showing a state of changing the position of a slit with respect to a mask of the immunoassay diagnostic apparatus according to the first and third embodiments of the present invention
  • FIG. 6 is an immunoassay according to the first and third embodiments of the present invention. It is a functional block diagram functionally showing the configuration of a diagnostic device.
  • the immunoassay diagnostic apparatus is a device capable of accurately detecting fluorescence generated in a sample strip in an entire area without a scanning operation using a mechanical driving unit or a camera, and the sample strip 100 and , An optical module 200, a main light receiving sensor 700, a mask 300, and a mask control unit 600.
  • the sample strip 100 is formed to adsorb and supply a biological sample through a capillary phenomenon, and a plurality of reaction regions 110 to which separate reactive substances are respectively applied are formed on one surface.
  • each reactive substance is combined with a biological sample having a specific disease to form a fluorescent reaction complex, and the fluorescent reaction complex is configured to generate fluorescence when light is irradiated.
  • the sample strip 100 includes a sample pad to which a biological sample is adsorbed and supplied, a probe pad to which a reactant for detection is applied, and a reaction region.
  • a membrane and an adsorption pad for smooth adsorption movement of the biological sample are sequentially disposed along the length direction of the sample strip 100.
  • the target analyte which is a specific disease factor in the biological sample, is combined with the detection reactant in the probe pad, and the combination of the detection reactant and the target analyte is developed along the membrane toward the adsorption pad, and in this process, the reaction region 110 It combines with the reactant at to form a fluorescent reaction complex.
  • the reactant for detection includes fluorescent particles, and biomaterials (for example, nucleic acids including DNA or RNA, amino acids, fats, glycoproteins, antibodies ), or a combination thereof), and it is formed in a structure in which fluorescent particles are bound, and generates fluorescence by receiving light.
  • biomaterials for example, nucleic acids including DNA or RNA, amino acids, fats, glycoproteins, antibodies ), or a combination thereof.
  • detection reactants include gas phase condensation method, high frequency plasma chemical synthesis method, conventional chemical precipitation, hydrothermal synthesis method, and electric dispersion reaction.
  • Method electric dispersion re-action method
  • combustive synthesis method sol-gel synthesis method
  • thermochemical synthesis method microfludizer process
  • microemulsion It can be formed through microemulson technology, high energy mechanical milling, or a combination thereof.
  • the optical module 200 is configured to irradiate the test light L to the sample strip 100 to generate fluorescence from the fluorescent reaction complex of the sample strip 100, and includes a light source unit for generating the test light, a lens module, etc. It is composed by
  • the main light-receiving sensor 700 is configured to receive and detect fluorescence R generated from the fluorescent reaction complex of the sample strip 100, and various types of sensors capable of detecting the fluorescence R may be applied.
  • the mask 300 is disposed between the optical module 200 and the sample strip 100 and is configured to guide the irradiation position of the inspection light L with respect to the sample strip 100.
  • the mask 300 is formed of a material that blocks the test light to block the test light, and a slit through which the test light L passes so that the test light is irradiated to the reaction region 110 of the sample strip 100
  • the portion 310 is formed. That is, the inspection light L irradiated by the optical module 200 is irradiated to the reaction region 110 of the sample strip 100 through the slit portion 310 formed in the mask 300.
  • the mask 300 is formed so that the formation position of the slit portion 310 can be adjusted within the mask 300 area.
  • the mask controller 600 controls the operation of the mask 300 so that the position of the slit portion 310 is adjusted within the mask 300 area.
  • a plurality of reaction regions 110 are formed in the sample strip 100 to diagnose various diseases from a biological sample, and the mask control unit 600 includes a slit 310 of the mask 300 of the sample strip 100.
  • the mask 300 is operated to be formed at a position corresponding to each of the reaction regions 110, and the position of the slit 310 is adjusted through this.
  • the slit portion 310 of the mask 300 is formed so that the inspection light L of the optical module 200 is irradiated to the reaction region 110 of the sample strip 100 through the slit portion 310.
  • the slit portion 310 of the mask 300 is a slit portion 310 at a position corresponding to each reaction region 110 of the fluorescence R generated from the fluorescent reaction complex of the sample strip 100.
  • the mask 300 is formed so that the inspection light L is not irradiated to the sample strip 100 through an area other than the slit portion 310, and similarly, the fluorescence R generated from the fluorescent reaction complex is transmitted to the slit portion ( It is formed not to enter the main light-receiving sensor 700 through an area other than 310).
  • the immunoassay diagnostic apparatus uses a separate mask 300 in which a slit portion 310 is formed between the optical module 200 and the sample strip 100.
  • a specific reaction region 110 of the sample strip 100 is irradiated through the slit portion 310, and accordingly, fluorescence is generated from the fluorescent reaction complex of the reaction region 110.
  • the generated fluorescence is the mask 300 It is configured to be detected by entering the main light-receiving sensor 700 through the slit portion 310 of.
  • the specific disease may be diagnosed by detecting fluorescence generated in each reaction region 110.
  • the plurality of reaction regions 110 of the sample strip 100 are simply controlled by simply adjusting the position of the slit 310 of the mask 300 without a mechanical driving unit for moving the sample strip 100 or the optical module 200. Since fluorescence detection of is possible, diagnosis accuracy and ease of use can be improved, and manufacturing ease and miniaturization are possible through simplification of the structure.
  • FIGS. 1 to 3 it is shown that the mask 300 is disposed between the optical module 200 and the sample strip 100. This will be described with reference to the slit portion 310 of the mask 300.
  • the reaction regions 110 of the sample strip 100 are formed at positions corresponding to each other. For example, as shown in FIGS. 2 and 3, a virtual straight line C connecting the center of the slit part 310 and the center of the reaction region 110 is irradiated from the optical module 200. It may be arranged to be positioned parallel to the optical axis I of L).
  • the slit portion 310 and the reaction region 110 may be configured to be arranged in a line along the optical axis direction of the inspection light, and through this, the inspection light L passes through the slit portion 310 to the reaction region 110.
  • the fluorescence R generated in the reaction region 110 may pass through the slit portion 310 and enter the main light-receiving sensor 700 through the optical module 200.
  • the area of the slit portion 310 of the mask 300 may be formed to be greater than or equal to the area of the reaction region 110 of the sample strip 100, and the slit portion 310 and the reaction region 110 May be formed to have the same shape.
  • the slit portion 310 and the reaction region 110 may be formed in a rectangular shape having a long and narrow width in one direction as shown in FIGS. 2 and 3, and the length of the slit portion 310 ( L2) may be formed to be greater than or equal to the length (L1) of the reaction region 110, and the width (W2) of the slit portion 310 may be formed to be greater than or equal to the width (W1) of the reaction region 110 have.
  • the mask 300 is formed so that the position of the slit part 310 can be adjusted within the area of the mask 300 without the movement of the mask 300, and the electrical signal generated by the mask control unit 600 As a result, the position of the slit 310 may be adjusted.
  • the mask 300 is disposed in the inner space of the mask case 302 and the mask case 302 formed of a transparent material so that the inspection light and fluorescence pass through, as shown in FIGS. It may be configured to include a liquid crystal module 301 including a liquid crystal that operates to pass or block the light by changing the arrangement state by a typical signal.
  • the liquid crystal module 301 has the most basic structure and is composed of a state in which liquid crystal is filled between two substrates spaced apart from each other. When an electric signal having a specific pattern is applied to the two substrates, the liquid crystal between the two substrates is an electric signal. It is applied to various display devices by using the principle that the arrangement state is changed according to the pattern and the area through which light passes according to the arrangement state of the liquid crystal.
  • the liquid crystal module 301 is used in a complex and colorful display device such as a mobile phone or a TV, and a display device such as an electronic calculator and an electronic clock may be exemplified in a simple form.
  • the liquid crystal module 301 is applied to the mask 300, and the slit portion 310 through which light can pass by adjusting the liquid crystal arrangement state of the liquid crystal module 301 by an electrical signal. ) Is formed, and the position of the slit 310 is configured to be freely adjusted by an electrical signal.
  • a plurality of reaction regions 110 are formed in the sample strip 100, and one slit portion 310 is formed in the mask 300, and the slit portion 310
  • the inspection light L of the optical module 200 is selectively and sequentially irradiated to the plurality of reaction regions 110 of the sample strip 100 through the slit portion 310, through this method, a plurality of All fluorescence generated from the fluorescent reaction complex in the reaction region 110 may be sequentially detected.
  • the mask control unit 600 controls the operation so that the formation position of the slit portion 310 continuously moves within the area of the mask 300 so that the inspection light L scans and irradiates a specific area of the sample strip 100.
  • the operation may be controlled so that the slit portion 310 is sequentially separately formed at a position corresponding to the reaction region 110 of the sample strip 100.
  • the corresponding position is based on preset slit position information according to the type of the sample strip 100 or the type of test disease.
  • the slit portion 310 may be formed in the.
  • the sample strip 100, the optical module 200, the main light-receiving sensor 700, and the mask 300 may be configured to be accommodated in a separate case 400
  • the sample strip 100 is inserted into a separate kit case (not shown) and is coupled to the case 400 in a kit unit so as to be inserted and withdrawn.
  • the biological sample is inserted into the case 400 while being adsorbed and supplied to the sample strip 100, and in this state, the test light from the optical module 200 passes through the slit 310 of the mask 300. ), and in the reaction region 110 of the sample strip 100, when a biological sample has a specific disease, a fluorescent reaction complex is formed to generate fluorescence.
  • the generated fluorescence is incident on the main light-receiving sensor 700 through the slit portion 310 of the mask 300. In this way, when the sample strip 100 is inserted into the case 400 in a kit unit, it is diagnosed whether there is a specific disease in the biological sample to be tested adsorbed on the sample strip 100.
  • the sample strip 100 may be of a different type in which the location or number of the reaction region 110 is different according to the type of a specific disease to be diagnosed. If the type of the sample strip 100 to be used is different, the corresponding Therefore, it is preferable that the position of the slit portion 310 of the mask 300 is also adjusted corresponding to the reaction region 110.
  • the position of the slit portion 310 formed in the mask 300 can be quickly and conveniently adjusted by an electrical signal, various types of sample strips 100 Also, it can be applied all through one device.
  • the immunoassay device is a mode selection unit that is selected and operated by a user to select different operation modes according to the type of the sample strip 100 to be applied. 610 may be provided.
  • the mask control unit 600 receives the mode selection signal from the mode selection unit 610 and applies the mask 300 so that the formation position of the slit unit 310 is adjusted in a form applied to the corresponding operation mode according to the selected operation mode signal. You can control the operation.
  • the reference position information of the slit unit 310 is preset corresponding to the operation mode selected by the mode selection unit 610, and the reference position information of the slit unit 310 according to each operation mode is a separate data storage unit. It can be stored at 610.
  • the mask control unit 600 determines the formation position of the slit unit 310 according to the reference position information of the slit unit 310 stored in the data storage unit 610.
  • the mask 300 may be operated to be adjusted.
  • the formation position of the slit 310 may be formed at different positions in the first operation mode and the second operation mode.
  • the slit unit 310 In the method of scanning a specific area of the sample strip 100 by continuously moving the position of the slit unit 310, in the case of scanning the entire area of the sample strip 100, the slit unit 310 according to the operation mode ) Although it is not important to change the formation position, in the method of sequentially separately forming the position of the slit part 310 at a position corresponding to the reaction region 110 of the sample strip 100, a preset slit according to the operation mode selection It is more advantageous in the operation control method to control the position of the slit part 310 through the formation position information of the part 310.
  • the user can select various operation modes through the mode selection unit 610, and masks (the masks can be applied to different types of sample strips 100 used in each operation mode).
  • the formation position of the slit portion 310 of 300) can be conveniently adjusted by an electrical signal, and accordingly, it can be applied to a single device for various types of sample strips 100, and can be used more conveniently.
  • the reference position information of the slit portion 310 according to the operation mode is the center of the reaction region 110 and the slit portion of the mask 300 according to the type of the sample strip 100 as described in FIGS. 2 and 3. 310)
  • the virtual straight line C connecting the center may be set to a position having a state parallel to the optical axis I of the inspection light.
  • the reference position information of the slit part 310 according to the operation mode is controlled by the mask control unit 600 to control the position of the slit part 310, and the fluorescent reaction complex of the sample strip 100 detected by the optical module 200 It may be set to a position where the detection amount of fluorescence generated from is highest. This is not to set the reference position geometrically, but to set the reference position based on the actual fluorescence detection amount, so it may be more advantageous in terms of the accuracy of the diagnosis result due to the nature of the method of diagnosing a disease according to fluorescence detection.
  • the slit portion 310 of the mask 300 is formed by using the liquid crystal module 301, the slit portion 310 is formed by an electrical signal without a mechanical driving unit.
  • the position can be adjusted in various ways. Therefore, in the first embodiment of the present invention, the inspection light passing through the slit portion 310 while moving the position of the slit portion 310 is selectively and sequentially irradiated to the reaction region 110 of the sample strip 100 Alternatively, operation may be controlled by the mask controller 600 to scan and irradiate the entire area of the sample strip 100.
  • the mask 300 is formed so that the size of the slit part 310 can be adjusted.
  • the mask control unit 600 may control the operation of the mask 300 so that the size of the slit unit 310 can be adjusted.
  • the size adjustment of the slit part 310 may be performed in a manner of comparing the fluorescence detection amount detected by the optical module 200 with a preset reference fluorescence detection amount, and adjusting the size of the slit part 310 according to the comparison result. have.
  • the mask control unit 600 masks the size of the slit unit 310 It is possible to control the operation 300.
  • the mask 300 may be operated to control the position of the slit 310.
  • FIG. 7 is an enlarged view of a portion "A" shown in FIG. 1 based on an immunoassay diagnosis apparatus according to a second embodiment of the present invention
  • FIG. 8 is an immunoassay diagnosis according to a second embodiment of the present invention. It is a diagram conceptually showing the arrangement of the sample strip and the mask of the device.
  • the immunoassay diagnostic apparatus is a device capable of accurately detecting fluorescence generated in a sample strip in an entire area using a separate mask, and includes a sample strip 100 and an optical module 200. And, it is configured to include a main light-receiving sensor 700, a mask 300 in which the slit portion 310 is formed, and a slit portion position adjusting means 800. These components may be configured to be accommodated in a separate case 400, and the sample strip 100 may be interchangeably coupled in a manner that is inserted and withdrawn into one side of the case 400.
  • the second embodiment Since the configurations of the sample strip 100, the optical module 200, and the main light-receiving sensor 700 are the same as those described in the first embodiment, the second embodiment has the same configuration as the configuration described in the first embodiment. Its explanation is omitted.
  • the mask 300 is disposed between the optical module 200 and the sample strip 100 and is configured to guide the irradiation position of the inspection light to the sample strip 100.
  • the mask 300 is formed of a material that blocks the inspection light, and the inspection light is disposed at a position corresponding to the reaction area 110 so that the inspection light L is irradiated to the reaction area 110 of the sample strip 100.
  • a slit portion 310 that can pass is formed. That is, the inspection light irradiated by the optical module 200 is irradiated to the reaction region 110 of the sample strip 100 through the slit portion 310 formed in the mask 300.
  • the slit position adjusting means 800 (see FIGS. 9 and 10) is configured to adjust the position of the slit part 310, and by adjusting the position of the slit part 310 by the slit part position adjusting means, the inspection light (L) may be selectively irradiated to the plurality of reaction regions 110 of the sample strip 100.
  • the slit position adjustment means may be configured in various ways, and a detailed description thereof will be described later with reference to FIGS. 9 and 10.
  • the position of the slit 310 formed in the mask 100 must be adjustable.
  • the test light L passing through the slit part 310 is reacted to a plurality of sample strips 100 It is configured to sequentially irradiate all of the regions 110.
  • the slit portion 310 of the mask 300 is a sample strip Fluorescence (R) generated from the fluorescent reaction complex of (100) is formed to be incident on the main light-receiving sensor 700 through the slit portion 310 and detected.
  • the mask 300 is formed so that the inspection light of the optical module 200 is not irradiated to the sample strip 100 through an area other than the slit portion 310, similarly, fluorescence R generated from the fluorescent reaction complex It is formed so as not to enter the main light-receiving sensor 700 through an area other than the slit portion 310.
  • the inspection light L of the optical module 200 is transmitted to the slit portion 310 by using a separate mask 300 having the slit portion 310 formed thereon.
  • fluorescence (R) is generated from the fluorescent reaction complex of the reaction region 110 to which the test light is irradiated, and at this time, the generated fluorescence (R) is configured to be detected by entering the main light-receiving sensor 700 through the slit portion 310 of the mask 300.
  • the inspection light can be sequentially irradiated to all of the plurality of reaction regions 110, and fluorescence generated from the fluorescent reaction complex formed in the plurality of reaction regions 110 ( R) may be sequentially incident to the main light-receiving sensor 700 through the slit portion 310 at the corresponding position and detected.
  • the mask 300 is shown to be disposed between the optical module 200 and the sample strip 100, and the slit portion of the mask 300 ( 310) and the reaction region 110 of the sample strip 100 are formed at positions corresponding to each other.
  • a virtual straight line C connecting the center of the slit part 310 and the center of the reaction region 110 is the optical axis of the inspection light irradiated from the optical module 200 It can be arranged to be positioned parallel to (I).
  • the slit portion 310 and the reaction region 110 may be configured to be arranged in a row along the direction of the optical axis I of the inspection light L, through which the inspection light L passes through the slit portion 310 Accordingly, the fluorescence R generated in the reaction region 110 may be irradiated to the reaction region 110 and incident on the optical module 200 through the slit portion 310.
  • the area of the slit portion 310 of the mask 300 may be formed to be greater than or equal to the area of the reaction region 110 of the sample strip 100, and the slit portion 310 and the reaction region 110 May be formed to have the same shape.
  • the slit portion 310 and the reaction region 110 may be formed in a rectangular shape having a long and narrow width in one direction as shown in FIGS. 7 and 8, and the length of the slit portion 310 ( L2) may be formed to be greater than or equal to the length (L1) of the reaction region 110, and the width (W2) of the slit portion 310 may be formed to be greater than or equal to the width (W1) of the reaction region 110 have.
  • the configuration of the slit portion position adjusting means 800 for adjusting the formation position of the slit portion 310 of the mask 300 will be described in more detail.
  • FIGS. 9 and 10 are diagrams schematically showing a state in which the position of the slit is adjusted through the slit position adjusting means of the immunoassay diagnostic apparatus according to the second embodiment of the present invention.
  • the slit portion position adjusting means 800 adjusts the position of the slit portion 310 so that the inspection light L is selectively irradiated to the plurality of reaction regions 110 of the sample strip 100.
  • one slit portion 310 is formed on the mask 300, and the slit portion position adjusting means 800 may be configured to adjust the position of the slit portion 310 in a manner of moving the mask 300. .
  • the operation member 810 may be formed in a rod shape with a thread on the outer circumferential surface thereof to be screwed with the mask 300, and the mask driver 820 rotates the operation member 810 so that the mask 300 moves.
  • a plurality of slit portions 310 are formed on the mask 300 so as to be positioned to correspond to the reaction region 110 of the sample strip 100, and the slit portion position adjusting means 800 is It may be configured to adjust the position of the slit portion 310 in a manner in which the slit portions 310 are sequentially opened one by one. This allows the position of the slit part 310 to be adjusted only by simply opening and closing the slit part 310 without directly moving the mask 300, so that the optical path can be guided more accurately, thereby enabling more accurate diagnosis.
  • Such a slit portion position adjusting means 800 may include, for example, a blocking plate 830 capable of selectively closing a plurality of slit portions 310 and a slit portion of any one of the plurality of slit portions 310 ( It may be configured to include a blocking plate driving unit 840 for operating the blocking plate 830 so that 310 is selectively opened.
  • a blocking plate driving unit 840 for operating the blocking plate 830 so that 310 is selectively opened.
  • This is exemplary, and may be configured in a manner of moving the blocking plate through the driving unit such that a blocking plate having a through hole is provided, and the through hole is positioned to correspond to any one of the plurality of slits 310. It can be changed variously.
  • the sample strip 100, the optical module 200, the main light-receiving sensor 700, and the mask 300 may be configured to be accommodated in a separate case 400
  • the sample strip 100 is inserted into a separate kit case (not shown) and is coupled to the case 400 in a kit unit so as to be inserted and withdrawn.
  • the biological sample is inserted into the case 400 while being adsorbed and supplied to the sample strip 100, and in this state, the test light from the optical module 200 passes through the slit 310 of the mask 300. ), and in the reaction region 110 of the sample strip 100, when a biological sample has a specific disease, a fluorescent reaction complex is formed to generate fluorescence.
  • the generated fluorescence is incident on the main light-receiving sensor 700 through the slit portion 310 of the mask 300. In this way, when the sample strip 100 is inserted into the case 400 in a kit unit, it is diagnosed whether there is a specific disease in the biological sample to be tested adsorbed on the sample strip 100.
  • the sample strip 100 may be of a different type in which the location or number of the reaction region 110 is different according to the type of a specific disease to be diagnosed. If the type of the sample strip 100 to be used is different, the corresponding Accordingly, a configuration for adjusting the formation position of the slit 310 may also be changed.
  • FIG. 11 is an enlarged view of a portion "A" shown in FIG. 1 based on an immunoassay diagnosis apparatus according to a third embodiment of the present invention
  • FIG. 12 is an immunoassay diagnosis according to a third embodiment of the present invention. It is a diagram conceptually showing the size and arrangement state of the sample strip and the mask of the device
  • FIG. 13 is a diagram illustrating a state of changing the size of the slit portion of the mask of the immunoassay diagnostic apparatus according to the third embodiment of the present invention. It is a drawing.
  • the immunoassay diagnostic apparatus is a device capable of accurately detecting reflected light generated from a sample strip in an entire area without a scanning operation using a mechanical driving unit or a camera, and the sample strip 100 and , An optical module 200, a main light receiving sensor 700, a mask 300, and a mask control unit 600.
  • the sample strip 100 is formed to adsorb and supply a biological sample through a capillary phenomenon, and a plurality of reaction regions 110 to which separate reactive substances are respectively applied are formed on one surface.
  • each reactive substance is combined with a biological sample having a specific disease to form a light-reflecting complex.
  • the light-reflecting complex reflects light to generate reflected light.
  • the sample strip 100 includes a sample pad to which a biological sample is adsorbed and supplied, a probe pad to which a reactant for detection is applied, and a reaction region.
  • a membrane and an adsorption pad for smooth adsorption movement of the biological sample are sequentially disposed along the length direction of the sample strip 100.
  • the target analyte which is a specific disease factor in the biological sample, is combined with the detection reactant in the probe pad, and the combination of the detection reactant and the target analyte is developed along the membrane toward the adsorption pad, and in this process, the reaction region 110 It combines with the reactant in to form a light reflective complex.
  • the reactant for detection includes microparticles or nanoparticles, and biomaterials (for example, nucleic acids including DNA or RNA, amino acids, fats, glycoproteins, It is formed in a structure in which nanoparticles are bound to an antibody (antibody, or a combination thereof).
  • Nanoparticles can be metal nanoparticles, such as gold (Au), silver (Ag), copper (Cu), aluminum (Al), nickel (Ni), cobalt (Co), iron (Fe), zinc (Zn) And at least one selected from manganese (Mn). These detection reactants are specifically bound to infectious disease factors contained in a biological sample.
  • detection reactants include gas phase condensation method, high frequency plasma chemical synthesis method, conventional chemical precipitation, hydrothermal synthesis method, and electric dispersion reaction.
  • Method electric dispersion re-action method
  • combustive synthesis method sol-gel synthesis method
  • thermochemical synthesis method microfludizer process
  • microemulsion It can be formed through microemulson technology, high energy mechanical milling, or a combination thereof.
  • the optical module 200 is configured to irradiate the test light L to the sample strip 100 so that reflected light is generated from the light reflection composite of the test strip 100, and includes a light source unit for generating the test light, a lens module, etc. It is composed by
  • the main light-receiving sensor 700 is configured to receive and detect the reflected light R generated from the light-reflecting composite of the sample strip 100, and various types of sensors capable of detecting the reflected light R may be applied.
  • the mask 300 is disposed between the optical module 200 and the sample strip 100 and is configured to guide the irradiation position of the inspection light L with respect to the sample strip 100.
  • the mask 300 is formed of a material that blocks the inspection light to block the inspection light, and the slit portion 310 through which the inspection light passes so that the inspection light is irradiated to the reaction region 110 of the sample strip 100.
  • the mask 300 is formed so that the formation position of the slit portion 310 can be adjusted within the mask 300 area, and at the same time, the shape and size of the slit portion 310 are adjusted within the mask 300 area. It is formed to be.
  • the mask control unit 600 controls the operation of the mask 300 so that the formation position of the slit portion 310 is adjusted within the mask 300 area, and also, the mask 300 so that the shape or size of the slit portion 310 is adjusted. ) To control the operation.
  • a plurality of reaction regions 110 are formed in the sample strip 100 to diagnose various diseases from a biological sample
  • the mask control unit 600 includes a slit 310 of the mask 300 of the sample strip 100.
  • the mask 300 is operated to be formed at a position corresponding to each of the reaction regions 110, through which the position of the slit portion 310 is adjusted, and its shape and size may be adjusted.
  • the slit portion 310 of the mask 300 is formed so that the inspection light L of the optical module 200 is irradiated to the reaction region 110 of the sample strip 100 through the slit portion 310.
  • the slit portion 310 of the mask 300 is a slit portion 310 at a position corresponding to each reaction region 110 of the reflected light R generated from the light-reflecting composite of the sample strip 100.
  • the mask 300 is formed so that the test light is not irradiated to the sample strip 100 through regions other than the slit portion 310, and similarly, the reflected light generated from the light-reflecting composite covers regions other than the slit portion 310. It is formed so as not to enter the main light-receiving sensor 700 through.
  • the immunoassay diagnostic apparatus uses a separate mask 300 in which a slit portion 310 is formed between the optical module 200 and the sample strip 100.
  • a specific reaction region 110 of the sample strip 100 is irradiated through the slit portion 310, and accordingly, reflected light is generated from the light reflection composite of the reaction region 110, and the generated reflected light is the mask 300 It is configured to be detected by entering the main light-receiving sensor 700 through the slit portion 310 of.
  • the test light can be simultaneously irradiated to the plurality of reaction regions 110 of the sample strip 100 only by adjusting the position of the slit portion 310 without moving the sample strip 100 or the optical module 200.
  • the specific disease may be diagnosed by detecting reflected light generated from each reaction region 110.
  • diagnosis accuracy and ease of use can be improved by simply disposing the mask 300 without a mechanical driving unit for moving the sample strip 100 or the optical module 200.
  • the inspection light of the optical module 200 is transmitted to a plurality of reaction regions ( 110) can be sequentially irradiated, and reflected light is incident on the main light-receiving sensor 700 through each slit 310, so that the reflected light is accurately and easily detected, and reflected light detection for all reaction areas 110 is performed. Since it can be performed sequentially, faster and more convenient use is possible.
  • the mask 300 is shown to be disposed between the optical module 200 and the sample strip 100, and the slit portion of the mask 300 ( 310) and the reaction region 110 of the sample strip 100 are formed at positions corresponding to each other.
  • a virtual straight line C connecting the center of the slit part 310 and the center of the reaction region 110 is the optical axis of the inspection light irradiated from the optical module 200 It can be arranged to be positioned parallel to (I).
  • the slit portion 310 and the reaction region 110 may be configured to be arranged in a line along the optical axis direction of the inspection light, through which the inspection light passes through the slit portion 310 and is irradiated to the reaction region 110
  • the reflected light generated in the reaction region 110 may pass through the slit portion 310 and enter the main light-receiving sensor 700.
  • the area of the slit portion 310 of the mask 300 may be formed to be smaller than or equal to the area of the reaction region 110 of the sample strip 100, and the slit portion 310 and the reaction region 110 May be formed to have the same shape.
  • the slit portion 310 and the reaction region 110 may be formed in a rectangular shape having a long and narrow width in one direction as shown in FIGS. 11 and 12, and the length of the slit portion 310 ( L) may be formed to be equal to or smaller than the length L of the reaction region 110, and the width W of the slit portion 310 may be formed to be equal to or smaller than the width W of the reaction region 110.
  • the shape and size of the slit portion 310 of the mask 300 is adjusted to adjust the amount of reflected light passing through the slit portion 310 from the reaction region 110 of the sample strip 100.
  • the reflected light R from the light-reflecting composite formed in the reaction region 110 of the sample strip 100 Is generated and is incident to the main light-receiving sensor 700 through the slit 310, and at this time, the reflected light is reflected light reflected from other areas other than the reflected light of the light-reflecting composite (for example, reflected light reflected from other parts, etc.) Etc.) may also enter the main light-receiving sensor 700 through the slit portion 310.
  • the reflected light R is reduced by reducing the width of the slit 310 from W1 to W2 as shown in FIG. 13, for example, by adjusting the shape and size of the slit 310 By controlling the amount of light passing through, the reflected light other than the reflected light of the actual light-reflecting composite does not pass, thereby improving diagnostic accuracy.
  • the mask 300 is formed so that the position, shape, and size of the slit portion 310 can be adjusted within the area of the mask 300 without moving the mask 300, and electricity generated by the mask controller 600
  • the position, shape, and size of the slit portion 310 may be adjusted according to an appropriate signal.
  • the mask 300 is disposed in the inner space of the mask case 302 and the mask case 302 formed of a transparent material to pass the inspection light and the reflected light as shown in FIG.
  • it may be configured to include a liquid crystal module 301 including a liquid crystal that operates to pass or block light.
  • the liquid crystal module 301 has the most basic structure and is composed of a state in which liquid crystal is filled between two substrates spaced apart from each other, and the description thereof is the same as the description in the first embodiment, and thus will be omitted herein.
  • the liquid crystal module 301 is applied to the mask 300, and the slit portion 310 through which light can pass by adjusting the liquid crystal arrangement state of the liquid crystal module 301 by an electrical signal.
  • the position of the slit 310 is configured to be freely adjusted by an electrical signal.
  • a plurality of reaction regions 110 are formed in the sample strip 100, and one slit portion 310 is formed in the mask 300, and the slit portion 310
  • the inspection light L of the optical module 200 is selectively and sequentially irradiated to the plurality of reaction regions 110 of the sample strip 100 through the slit portion 310, through this method, a plurality of All of the reflected light generated from the light reflection composite in the reaction region 110 may be sequentially detected.
  • the mask control unit 600 controls the operation so that the formation position of the slit portion 310 continuously moves within the area of the mask 300 so that the inspection light L scans and irradiates a specific area of the sample strip 100.
  • the operation may be controlled so that the slit portion 310 is sequentially separately formed at a position corresponding to the reaction region 110 of the sample strip 100.
  • the corresponding position is based on preset slit position information according to the type of the sample strip 100 or the type of test disease.
  • the slit portion 310 may be formed in the.
  • the shape and size of the slit portion 310 can be freely adjusted by adjusting the liquid crystal arrangement state of the liquid crystal module 301 by an electrical signal.
  • the mask control unit 600 controls the operation of the mask 300 as described above to prevent reflected light other than the reflected light reflected from the light reflection composite of the sample strip 100 from passing through the slit unit 310. ) By adjusting the shape and size, through which the detection accuracy of the reflected light of the optical module 200 may be improved.
  • the sample strip 100, the optical module 200, the main light-receiving sensor 700, and the mask 300 may be configured to be accommodated in a separate case 400
  • the sample strip 100 is inserted into a separate kit case (not shown) and coupled to the case 400 in a kit unit so as to be inserted and withdrawn.
  • the biological sample is inserted into the case 400 while being adsorbed and supplied to the sample strip 100, and in this state, the test light from the optical module 200 passes through the slit 310 of the mask 300. ), and in the reaction region 110 of the sample strip 100, when a biological sample has a specific disease, a light-reflecting complex is formed to generate reflected light.
  • the generated reflected light is incident on the main light-receiving sensor 700 through the slit portion 310 of the mask 300 and is detected. In this way, when the sample strip 100 is inserted into the case 400 in a kit unit, it is diagnosed whether there is a specific disease in the biological sample to be tested adsorbed on the sample strip 100.
  • the sample strip 100 may be of a different type in which the location or number of the reaction region 110 is different according to the type of a specific disease to be diagnosed. If the type of the sample strip 100 to be used is different, the corresponding Accordingly, it is preferable that the formation position of the slit portion 310 of the mask 300 is also adjusted corresponding to the reaction region 110, and the shape or size of the slit portion 310 may also be adjusted.
  • the position, shape, and size of the slit portion 310 formed in the mask 300 can be quickly and conveniently adjusted by an electrical signal, various types of sample strips For (100), it can be applied all through one device.
  • the immunoassay device is a mode selection unit that is selected and operated by a user to select different operation modes according to the type of the sample strip 100 to be applied. 610 may be provided.
  • the mask control unit 600 receives the mode selection signal from the mode selection unit 610 and adjusts the position, shape, and size of the slit unit 310 in a form applied to the corresponding operation mode according to the selected operation mode signal. 300) can be operated.
  • reference position information, reference shape information, and reference size information of the slit unit 310 are preset in response to the operation mode selected by the mode selection unit 610, and the reference of the slit unit 310 according to each operation mode Location information, reference shape information, and reference size information may be stored in a separate data storage unit 610.
  • the mask control unit 600 adjusts the position of the slit unit 310 according to the reference position information of the slit unit 310 stored in the data storage unit 610.
  • the mask 300 may be operated to be controlled, and at the same time, the mask 300 may be operated to adjust the shape and size of the slit part 310 according to reference shape information and reference size information of the slit part 310.
  • the formation position of the slit 310 may be formed at different positions in the first operation mode and the second operation mode.
  • the slit unit 310 In the method of scanning a specific area of the sample strip 100 by continuously moving the position of the slit unit 310, in the case of scanning the entire area of the sample strip 100, the slit unit 310 according to the operation mode ) Although it is not important to change the formation position, in the method of sequentially separately forming the position of the slit part 310 at a position corresponding to the reaction region 110 of the sample strip 100, a preset slit according to the operation mode selection It is more advantageous in the operation control method to control the position of the slit part 310 through the formation position information of the part 310.
  • the user can select various operation modes through the mode selection unit 610, and masks (such as to be applied to different types of sample strips 100 used in each operation mode)
  • the formation position of the slit portion 310 of 300) can be conveniently adjusted by an electrical signal, and accordingly, it can be applied to a single device for various types of sample strips 100, and can be used more conveniently.
  • the reference position information of the slit portion 310 according to the operation mode is the center of the reaction region 110 and the slit portion of the mask 300 according to the type of the sample strip 100 as described in FIGS. 11 and 12. 310)
  • the virtual straight line C connecting the center may be set to a position having a state parallel to the optical axis I of the inspection light.
  • the reference position information of the slit unit 310 according to the operation mode is adjusted by the mask control unit 600 to adjust the position of the slit unit 310, and the light reflection of the sample strip 100 detected by the main light-receiving sensor 700
  • the detected amount of reflected light generated from the composite may be set to the position in the highest state. This is not to set the reference position geometrically, but to set the reference position based on the actual reflected light detection amount, and thus, it may be more advantageous in terms of the accuracy of the diagnosis result due to the nature of a method of diagnosing a disease according to reflected light detection.
  • the slit portion 310 of the mask 300 is formed by using the liquid crystal module 301, the slit portion 310 is The position can be adjusted in various ways. Therefore, in the third embodiment of the present invention, the inspection light passing through the slit 310 while moving the position of the slit 310 is selectively and sequentially irradiated to the reaction region 110 of the sample strip 100 or Alternatively, the operation may be controlled by the mask controller 600 to scan and irradiate the entire area of the sample strip 100.
  • the reference shape and size of the slit portion 310 may all be the same, but the reference shape and size may be changed as needed. In this case, the reference shape and size information Accordingly, the shape and size of the slit portion 310 should be adjusted.
  • the reference shape information and the reference size information for the slit part 310 are set based on the detection amount information of the reflected light detected by the main light-receiving sensor 700 according to the type of the sample strip 100 used in each operation mode. It may be stored in the data storage unit 610.
  • the shape and size of the slit 310 may be adjusted based on the reference shape information and the reference size information, but unlike this, in the process of detecting the reflected light on the sample strip 100, the optical module 200 When the detected amount of reflected light is different from the reference detected amount information in the corresponding operation mode stored in the data storage unit 620, it may be supplemented.
  • the user can select various operation modes through the mode selection unit 610, and can be applied to different types of sample strips 100 used in each operation mode.
  • the position, shape, and size of the slit portion 310 of the mask 300 are conveniently controlled by an electrical signal, and accordingly, it is applicable to all kinds of sample strips 100 and can be conveniently used. .
  • FIG. 14 and 15 are diagrams conceptually showing a configuration of an optical module of an immunoassay diagnostic apparatus according to an embodiment of the present invention
  • FIG. 16 is an exemplary arrangement of a mask according to an embodiment of the present invention. It is a drawing shown as.
  • the light source unit 210 generating inspection light and the inspection light L generated from the light source unit 210 pass.
  • it may be configured to include a lens module 250 arranged to pass the fluorescence (R) or reflected light generated from the fluorescent reaction complex or the light reflecting complex of the sample strip (100).
  • the main light-receiving sensor 700 is arranged to receive light after the fluorescence (R) or reflected light generated from the fluorescent reaction complex or the light reflective complex of the sample strip 100 passes through the lens module 250.
  • the optical module 200 includes a dichroic filter 220 and a dichroic filter 220 that partially reflects the inspection light generated from the light source unit 210 and proceeds toward the sample strip 100.
  • Auxiliary light-receiving sensor that is disposed opposite to the light source unit 210 and receives and detects some inspection light that has passed through the dichroic filter 220 without being reflected by the dichroic filter 220 generated from the light source unit 210 It may be configured to further include (240).
  • the light source unit 210 may be a UV LED that generates ultraviolet rays to generate fluorescence or reflected light from the reaction region 110 of the sample strip 100.
  • the mask 300 is between the lens module 250 and the sample strip 100 so that the inspection light passing through the lens module 250 is irradiated to the sample strip 100 through the slit portion 310.
  • the mask 300 includes a space between the lens module 250 and the sample strip 100, a space between the lens module 250 and the main light-receiving sensor 700, and the lens module ( 250) may be disposed to be positioned in any one of the spaces between the plurality of lenses.
  • the lens module 250 may be composed of a plurality of various lenses.
  • the light source unit 210, the main light receiving sensor 700, and the auxiliary light receiving sensor 240 Various lenses capable of condensing light or converting it into parallel light may be disposed in front.
  • a band filter 260 capable of filtering light in a specific wavelength range may be disposed in front of the light source unit 210 and the main light-receiving sensor 700.
  • a light source control unit 500 capable of controlling the operation state of the light source unit 210 may be provided, and the light source unit 210 is detected by the auxiliary light receiving sensor 240.
  • the operation may be controlled by the light source control unit such that the intensity of the inspection light generated from the light source unit 210 is adjusted according to the intensity of the inspection light.
  • the intensity of the inspection light irradiated from the light source unit 210 to the sample strip 100 can be kept constant. Since the intensity of fluorescence or reflected light generated from the sample strip 100 can also be kept constant, the reference value of the detection amount of fluorescence or reflected light detected by the main light-receiving sensor 700 can be accurately set, making it easy to change the detection amount of fluorescence or reflected light. Recognition, and accordingly, the accuracy of diagnosis for a specific disease can be improved.
  • the inspection light generated from the light source unit 210 is partially reflected through the dichroic filter 220 as shown in FIG. 14 and passes through the slit portion 310 of the mask 300 to pass through the reflective area of the sample strip 100. It is irradiated to 110, and a part of the inspection light passes through the dichroic filter 220 and is received by the auxiliary light-receiving sensor 240 and is detected.
  • the intensity of the inspection light generated by the light source unit 210 is maintained constant by the optical control unit 500 according to the intensity of the inspection light received by the auxiliary light receiving sensor 240.
  • Fluorescence or reflected light generated in the reflective region 110 of the sample strip 100 passes through the slit portion 310 of the mask 300 and enters the optical module 200, as shown in FIG. Some of the reflected light passes through the dichroic filter 220 and is received by the main light-receiving sensor 700 to be detected.
  • a specific disease may be diagnosed through detection of fluorescence or reflected light received by the main light-receiving sensor
  • the inspection light of the light source unit 210 passes through the slit portion 310 of the mask 300 and is irradiated to the reaction region of the sample strip 100.
  • the inspection light of the light source unit 210 is It may be configured to irradiate the reaction region of the sample strip 100 without passing through the slit portion 310 of the mask 300.
  • the fluorescence or reflected light generated from the reaction region of the sample strip 100 is configured to pass through the slit portion 310 of the mask 300 and receive light by the main light-receiving sensor 700 in the same manner as described above.
  • fluorescence or reflected light generated from the plurality of reaction regions of the sample strip 100 is sequentially received by the main light-receiving sensor 700.
  • the inspection light of the light source unit 210 does not necessarily need to be guided through the slit portion 310 of the mask 300, and can be simply irradiated to the entire area of the sample strip 100, and By allowing the main light-receiving sensor 700 to sequentially receive the fluorescent or reflected light generated in the plurality of reaction regions of the strip 100 through the slit 310, the fluorescent or reflected light for the plurality of reaction regions is accurately Can be detected.
  • the degree of freedom of arrangement for the light source unit 210 is further increased. It is easy to design and manufacture.
  • the light source unit 210 may be freely disposed at a separate location regardless of the arrangement state of the lens module 250, the main light receiving sensor 700, and the mask 300.
  • the test light of the light source unit 210 must be disposed so that all the plurality of reaction regions of the sample strip 100 are irradiated.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Analytical Chemistry (AREA)
  • General Physics & Mathematics (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Cell Biology (AREA)
  • Medicinal Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Plasma & Fusion (AREA)
  • Investigating, Analyzing Materials By Fluorescence Or Luminescence (AREA)

Abstract

La présente invention concerne et fournit un appareil de diagnostic pour immunoessai selon lequel, sans déplacer séparément une bande échantillon ou un module optique, un masque, présentant une partie fendue, est simplement disposé, et la position de la partie fendue est modifiée, et ainsi une lumière de test peut être irradiée avec précision sur une région de réaction de la bande échantillon, et la fluorescence ou une lumière réfléchie se produisant à partir de la région de réaction de la bande échantillon peut être détectée avec précision, ce qui permet par conséquent d'améliorer la précision du diagnostic et le confort d'utilisation.
PCT/KR2020/006709 2019-05-23 2020-05-22 Appareil de diagnostic pour immunoessai WO2020235964A1 (fr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
KR10-2019-0060498 2019-05-23
KR1020190060479A KR102273586B1 (ko) 2019-05-23 2019-05-23 액정 제어형 면역 분석 진단 장치
KR1020190060498A KR102273588B1 (ko) 2019-05-23 2019-05-23 액정을 이용한 광학 스캔식 면역 분석 진단 장치
KR10-2019-0060479 2019-05-23
KR10-2019-0060497 2019-05-23
KR1020190060497A KR102273587B1 (ko) 2019-05-23 2019-05-23 이동식 슬릿을 이용한 면역 분석 진단 장치

Publications (1)

Publication Number Publication Date
WO2020235964A1 true WO2020235964A1 (fr) 2020-11-26

Family

ID=73458742

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2020/006709 WO2020235964A1 (fr) 2019-05-23 2020-05-22 Appareil de diagnostic pour immunoessai

Country Status (1)

Country Link
WO (1) WO2020235964A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20080000937A (ko) * 2006-06-28 2008-01-03 (주)미래컴퍼니 액정기판 검사장치 및 검사방법
KR20140060858A (ko) * 2012-11-12 2014-05-21 삼성전자주식회사 액체-액체 계면 형상에 대한 측정 방법, 측정 장치 및 이를 채용한 미세 유체 방식의 가변 광학 소자
KR20170101822A (ko) * 2016-02-26 2017-09-06 프리시젼바이오 주식회사 면역분석 진단 장치
WO2018055410A1 (fr) * 2016-09-26 2018-03-29 Sumitomo Chemical Company Limited Dispositif d'essai analytique
KR101874965B1 (ko) * 2017-07-03 2018-07-05 (주)시정 빔 스플리터를 이용한 시정계

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20080000937A (ko) * 2006-06-28 2008-01-03 (주)미래컴퍼니 액정기판 검사장치 및 검사방법
KR20140060858A (ko) * 2012-11-12 2014-05-21 삼성전자주식회사 액체-액체 계면 형상에 대한 측정 방법, 측정 장치 및 이를 채용한 미세 유체 방식의 가변 광학 소자
KR20170101822A (ko) * 2016-02-26 2017-09-06 프리시젼바이오 주식회사 면역분석 진단 장치
WO2018055410A1 (fr) * 2016-09-26 2018-03-29 Sumitomo Chemical Company Limited Dispositif d'essai analytique
KR101874965B1 (ko) * 2017-07-03 2018-07-05 (주)시정 빔 스플리터를 이용한 시정계

Similar Documents

Publication Publication Date Title
WO2018143680A1 (fr) Appareil d'immunoessai en phase liquide automatisé
US4626684A (en) Rapid and automatic fluorescence immunoassay analyzer for multiple micro-samples
KR101074560B1 (ko) 현미경 및 시료 관찰 방법
WO2020027470A1 (fr) Appareil d'immunoessai en phase liquide automatisé et procédé associé
WO2016088992A1 (fr) Appareil de test et son procédé de commande
WO2018043857A1 (fr) Dispositif de lecture de signal de fluorescence doté d'une fonction de détection de flux d'échantillon
EP3167276B1 (fr) Imageur de contact
WO2010008238A2 (fr) Capteur de détection immunochromatographique comprenant un guide d'ondes optiques et procédé de détection faisant appel à ce dernier
WO2020235964A1 (fr) Appareil de diagnostic pour immunoessai
JPH1164213A (ja) サンプルプレート
WO2018062587A1 (fr) Cassette séparable permettant de mesurer l'hémoglobine glyquée
KR20200134689A (ko) 이동식 슬릿을 이용한 면역 분석 진단 장치
WO2022182125A1 (fr) Cartouche de chargement de gouttelettes de type désactivé intégrée à un dispositif de commande de chaleur pour mesurer un signal optique
WO2010098528A1 (fr) Dispositif biocapteur et procédé de détection permettant la détection en temps réel de changements physiques dans des matériels biologiques
TWI269886B (en) Microscope and specimen observation method
WO2021132847A1 (fr) Procédé de fabrication d'une bandelette réactive pour analyse d'immunoessai multiplex, et bandelette réactive fabriquée à l'aide de celui-ci
WO2020197193A1 (fr) Dispositif et procédé de dosage immunologique
JPH1090610A (ja) 走査型プローブ顕微鏡
WO2020134630A1 (fr) Analyseur elisa
WO2022114530A1 (fr) Cartouche de diagnostic pour diagnostic immunitaire, et lecteur et système de diagnostic l'utilisant
WO2020040509A1 (fr) Puce de biocapteur haute sensibilité utilisant un marqueur de coefficient d'extinction élevé et substrat diélectrique, système de mesure et méthode de mesure
KR20200134681A (ko) 액정 제어형 면역 분석 진단 장치
WO2023074988A1 (fr) Procédé d'analyse de réponse immunitaire liquide à l'aide de billes magnétiques
WO2020022713A1 (fr) Dispositif de bio-diagnostic fondé sur un capteur d'image utilisant une lumière latérale, et cartouche intégrée
KR102273588B1 (ko) 액정을 이용한 광학 스캔식 면역 분석 진단 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: 20810435

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 20810435

Country of ref document: EP

Kind code of ref document: A1