KR101254617B1 - Diagnostic Apparatus for Immunoassay - Google Patents
Diagnostic Apparatus for Immunoassay Download PDFInfo
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- KR101254617B1 KR101254617B1 KR1020100116319A KR20100116319A KR101254617B1 KR 101254617 B1 KR101254617 B1 KR 101254617B1 KR 1020100116319 A KR1020100116319 A KR 1020100116319A KR 20100116319 A KR20100116319 A KR 20100116319A KR 101254617 B1 KR101254617 B1 KR 101254617B1
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Abstract
An immunoassay diagnostic device is provided. The diagnostic device comprises a microfluidic chip, a microfluid, comprising a sensing unit having at least one fluorescent particle-biomaterial complex that specifically binds to the biological sample to form a fluorescent particle-biomaterial complex for detection of the biological sample. It includes a light source unit for providing light to the chip to generate fluorescence from the fluorescent particle-bio binder material complex, and a sensor unit for detecting the fluorescence generated from the microfluidic chip. The light source unit includes a light source layer and a light guide plate, and the light guide plate includes at least one light guide layer, wherein the light guide layer has a rectangular or polygonal closed cross-sectional shape having an outer circumferential surface and an inner circumferential surface, wherein the outer circumferential surface and the inner circumferential surface are formed of a first reflective surface and a first light guide layer. 2, and the light source layer has the same number of light source arrays as the polygon, but the light source array has at least one light source.
Description
The present invention relates to an immunoassay diagnostic apparatus, and more particularly, to an immunoassay diagnostic apparatus including a light source unit having a light guide plate.
Test methods used for diagnosing diseases are mainly based on color development, fluorescence, etc. by enzyme reaction, but recently, immunoassay using an immune response between an antigen and an antibody has also been used. Such immunoassay methods are mainly labeled biosensors in which antibodies are labeled with radioisotopes or fluorescent substances to determine the presence or absence of antigens and quantified by the intensity of radiation or fluorescence.
Conventional immunoassay methods measure signals obtained by labeling antigens or antibodies with radioactive substances, luminescent substances or fluorescent substances, Enzyme Linked Immunosorbent Assays (ELISAs) and Western blotting that combine photolabels with catalytic reactions of enzymes. Optical measurement methods such as (Western blotting) are the most used. These methods require complex procedures that can be performed primarily by laboratory-based skilled researchers, and the devices for analysis are expensive, large-scale devices, and require long analysis time.
Antibodies, such as the target substance of the immune sensor, are present in very low concentrations in biological samples such as whole blood, serum, urine, etc., and therefore, the immune sensor is more sensitive than the biosensor technology of detecting other substances. It should be equipped with highly sensitive signaling technology which is much better in terms of detection limit. In addition, since antibodies, protein antigens, and proteins are easily changed in structure due to changes in the external environment, the recognition site of the antigen or antibody is deteriorated, and thus, it is easy to lose the intrinsic biometric function. In the condition of the immune sensor to be analyzed in the solid form, the fabrication of a sensor surface suitable for the biological materials that can maintain the activity of these biological materials, the immobilization technology of the biological materials to raise the detection limit, and the biometric response are quantified signals. It is necessary to secure the measuring method to be switched.
Rapid diagnostic test kits for immunoassays (hereafter referred to as rapid diagnostic test kits) are point-of-tests that allow for diagnostic testing using biological samples such as blood, urine, and saliva. Inspection tool for care. Examples of such rapid diagnostic test kits include pregnancy diagnosis kits and AIDS diagnosis kits.
Such a diagnostic device must establish a method capable of detecting a predetermined biomaterial (protein or DNA, etc.) for diagnosis. Background Art A fluorescent labeling method using an organic dye or the like has been known as a conventional method for detecting a biological material. The fluorescent label emits various colors depending on the type to provide a detection means for the target biomaterial.
Meanwhile, when a plurality of biological materials are to be detected at the same time, a plurality of fluorescent labels emitting light with different colors are required. However, when a plurality of colors emit light at the same time, photobleaching may occur. In addition, the conventional fluorescent label has a disadvantage of having optically narrow excitation and emission band width, and when combined with the biomaterial, may adversely affect the activity of the biomaterial. There are many limitations such as.
The problem to be solved by the present invention can be irradiated with light of a desired intensity or / and various wavelengths with a microfluidic chip in order to qualitatively and quantitatively analyze the infectious disease and the extent of infection of the infectious disease contained in the biological sample. An immunoassay diagnostic apparatus including a light source unit is provided.
The problems to be solved by the present invention are not limited to the above-mentioned problems, and other problems not mentioned can be clearly understood by those skilled in the art from the following description.
In order to achieve the above object, the present invention provides an immunoassay diagnostic apparatus. The diagnostic device comprises a microfluidic chip, a microfluid, comprising a sensing unit having at least one fluorescent particle-biomaterial complex that specifically binds to the biological sample to form a fluorescent particle-biomaterial complex for detection of the biological sample. It may include a light source unit for providing fluorescence from the fluorescent particle-bio-binding material complex by providing light to the chip, and a sensor unit for detecting the fluorescence generated from the microfluidic chip. The light source unit includes a light source layer and a light guide plate, and the light guide plate includes at least one light guide layer, wherein the light guide layer has a rectangular or polygonal closed cross-sectional shape having an outer circumferential surface and an inner circumferential surface, wherein the outer circumferential surface and the inner circumferential surface are formed of a first reflective surface and a first light guide layer. The reflective surface may be configured, and the light source layer may have the same number of light source arrays as the polygon, but the light source array may have at least one light source.
The light provided from the light source is incident on the first reflective surface of the light guide layer, the light reflected by the first reflective surface is incident on the second reflective surface, and the light reflected by the second reflective surface is detected by the microfluidic chip. It can be investigated negatively.
The light source arrangement of the light source layer includes a plurality of light sources, and the plurality of light sources may emit light of different wavelengths.
The light source array of the light source layer may include a plurality of light sources, and the light guide plate may have a form in which the same number of light guide layers are stacked as the number of light sources of the light source array. The plurality of light sources of the light source array of the light source layer may inject light into the first reflective surfaces of the different light guide layers of each of the light guide layers stacked.
The light guide lens may further include a light guide lens provided between the light source and the light guide plate. The light guide lens may include at least one selected from a Fresnel lens, a hemispherical lens, a planar lens, or a combination thereof.
The light guide lens is a Fresnel lens or a hemispherical lens, and the light provided from the light source can be focused by the light guide lens and incident on the first reflective surface of the light guide layer.
The light guide lens is a planar lens, and light provided from the light source may pass through the light guide lens and enter the first reflective surface of the light guide layer.
The light guide plate may further include a first reflective coating layer provided on a first side adjacent to the light source layer and a second reflective coating layer provided on a second side opposite to the first side.
The closed polygonal planar shape with the outer circumferential surface and the inner circumferential surface of the light guide layer may be square, regular hexagonal, regular octagonal or circular.
The closed polygonal planar shape may be square, regular hexagonal or regular octagonal, and the number of light source arrays in the light source layer may be four, six or eight, respectively.
The closed polygonal planar cross-sectional shape is circular, and the number of light source arrays of the light source layer may be a maximum value in consideration of the minimum distance required between the light source arrays.
The first and second reflective surfaces of the light guide layer may include at least one selected from a parabolic mirror, a hemispherical mirror, a planar mirror, or a combination thereof.
The sensing unit of the microfluidic chip may have two or more kinds of fluorescent particle-biomaterial complexes.
Fluorescent particle-biomaterial composites include gas phase condensation, high frequency plasma chemical synthesis, chemical precipitation, hydrothermal synthesis, electrical dispersion reaction, combustion synthesis, sol-gel synthesis, thermochemical synthesis, microfluidizer process, microemulsion technique and high It can be formed by at least one manner selected from among energy mechanical milling.
The biomaterial of the fluorescent particle-biomaterial complex may include at least one selected from nucleic acids, amino acids, fats, glycoproteins, and antibodies, including DNA or RNA.
The biological sample that specifically binds to the fluorescent particle-biomaterial complex is an antigen, and the biomaterial may be an antibody.
The light source may be a light emitting diode.
The sensor unit may be a silicon detector, a Sisid photosensitive device, or a CMOS photosensitive device.
The apparatus may further include a measuring unit configured to convert the fluorescence sensed by the sensor unit into an electrical signal.
The present invention also provides another immunoassay diagnostic apparatus. The diagnostic device comprises a microfluidic chip, a microfluid, comprising a sensing unit having at least one fluorescent particle-biomaterial complex that specifically binds to the biological sample to form a fluorescent particle-biomaterial complex for detection of the biological sample. It may include a light source unit for providing fluorescence from the fluorescent particle-bio-binding material complex by providing light to the chip, and a sensor unit for detecting the fluorescence generated from the microfluidic chip. The light source unit includes a light source layer and a light guide plate, and the light guide plate includes at least one light guide layer, wherein the light guide layer has a closed rectangular planar cross section having an outer circumferential surface and an inner circumferential surface, wherein the outer circumferential surface and the inner circumferential surface in one direction are the first reflective surface and The light guide layer has an inclination that decreases as the widths of the outer circumferential surface and the inner circumferential surface in one direction move away from the light source layer, and the light source layer is respectively disposed between the outer circumferential surface and the inner circumferential surface in one direction. Although having a light source array, the light source array may be characterized by having at least one light source.
The light source arrangement of the light source layer includes a plurality of light sources, and the plurality of light sources may emit light of different wavelengths.
The light source array of the light source layer may be provided in plurality between the outer circumferential surface and the inner circumferential surface of one direction, and the light guide plate may have a shape in which the same number of light guide layers are stacked.
The light guide lens may further include a light guide lens provided between the light source and the light guide plate.
As described above, according to the problem solving means of the present invention by including a light source unit that can irradiate light of various intensities or light of a desired intensity with a microfluidic chip, whether or not the infection of the infectious disease contained in the biological sample and the degree of infection It can be analyzed qualitatively and quantitatively. Accordingly, an immunoassay glucose sugar device capable of analyzing qualitatively and quantitatively and accurately and infectiously an infectious disease included in a biological sample can be provided.
In addition, the size of the light source unit can be reduced, so that the size of the immunoassay diagnostic apparatus can be reduced, and mass production can be performed, thereby reducing the manufacturing cost of the immunoassay diagnostic apparatus.
1 is a schematic block diagram illustrating the structure of an immunoassay diagnostic apparatus according to an embodiment of the present invention;
2 is a schematic block diagram illustrating the configuration of a light source unit of an immunoassay diagnostic apparatus according to an embodiment of the present invention;
3 to 6 are plan views illustrating light source parts of an immunoassay diagnostic apparatus according to embodiments of the present invention;
7 is a conceptual configuration of a partial configuration including a cross-sectional view taken along line II ′ of a light source unit of the immunoassay diagnostic apparatus of FIG. 5 to describe an operation of the immunoassay diagnostic apparatus according to an embodiment of the present invention. Degree;
FIG. 8 is a cross-sectional view taken along line II-II ′ of FIG. 6 to describe a light guide plate of a light source unit of an immunoassay diagnostic apparatus according to an embodiment of the present invention;
9 is a plan view for explaining a light source unit of an immunoassay diagnostic apparatus according to another embodiment of the present invention;
FIG. 10 is a cross-sectional view taken along line III-III ′ of FIG. 9 to describe a light source unit of an immunoassay diagnostic apparatus according to another embodiment of the present invention;
11 is a cross-sectional view of a schematic partial configuration for explaining the operation of the immunoassay diagnostic apparatus according to an embodiment of the present invention.
Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS The advantages and features of the present invention and the manner of achieving them will become apparent with reference to the embodiments described in detail below with reference to the accompanying drawings. However, the present invention is not limited to the embodiments described herein but may be embodied in different forms. Rather, the embodiments disclosed herein are provided so that the disclosure can be thorough and complete, and will fully convey the concept of the invention to those skilled in the art, and the invention is only defined by the scope of the claims. Like reference numerals refer to like elements throughout the specification.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. In the present specification, the singular form includes plural forms unless otherwise specified in the specification. It is to be understood that the terms 'comprises' and / or 'comprising' as used herein mean that an element, step, operation, and / or apparatus is referred to as being present in the presence of one or more other elements, Or additions. In addition, since they are in accordance with the preferred embodiment, the reference numerals presented in the order of description are not necessarily limited to the order.
In addition, the embodiments described herein will be described with reference to cross-sectional views and / or plan views, which are ideal illustrations of the present invention. In the drawings, the size and / or thickness of the components are exaggerated for the effective description of the technical content. Thus, the shape of the illustrations may be modified by manufacturing techniques and / or tolerances. Accordingly, the embodiments of the present invention are not limited to the specific forms shown, but also include variations in forms generated by the manufacturing process. Accordingly, the components illustrated in the figures have schematic attributes, and the appearance of the components illustrated in the figures is intended to illustrate a particular form of component of the apparatus and is not intended to limit the scope of the invention.
1 is a schematic block diagram illustrating the configuration of an immunoassay diagnostic apparatus according to an embodiment of the present invention.
Referring to FIG. 1, the immunoassay
The
The biomaterial of the fluorescent particle-biomaterial complex may include at least one selected from nucleic acid, amino acid, fat, glycoprotein, and antibody including DNA or RNA. Can be.
Fluorescent particle-biomaterial complexes include gas phase condensation method, high frequency plasma chemical synthesis method, conventional chemical precipitation, hydrothermal synthesis method, and electrical dispersion reaction. Electric dispersion re-action method, combustive synthesis method, sol-gel synthesis method, thermochemical synthesis method, microfludizer process, microemulsion It may be formed by at least one method selected from microemulson technology and high energy mechanical milling.
When the infectious disease included in the biological sample specifically binding to the fluorescent particle-biomaterial complex is an antigen, the biomaterial of the fluorescent particle-biomaterial complex may be an antibody.
The sensing unit of the
The
The biological sample collected from the infected patient to be diagnosed is injected into the
The
An
When the
As described above, the
The
When the
The
2 is a schematic block diagram illustrating the configuration of a light source unit of an immunoassay diagnostic apparatus according to an embodiment of the present invention.
Referring to FIG. 2, the
The definition of the closed polygonal planar cross-section used above defines that the material exists between the inner circumferential surface and the outer circumferential surface, and that there is no empty space inside the inner circumferential surface, or that the material exists between the inner circumferential surface and the outer circumferential surface. For forms in which other substances may be present.
The
When the light source array of the
The
The light provided from the light source is incident on the first reflecting surface of the light guide layer, the light reflected by the first reflecting surface is incident on the second reflecting surface, and the light reflected by the second reflecting surface is immunoassay diagnostic apparatus ( 1 may be irradiated to the sensing unit of the microfluidic chip (see 110 of FIG. 1). The first and second reflective surfaces of the light guide layer may include at least one selected from a parabolic mirror, a hemispherical mirror, a planar mirror, or a combination thereof.
The
3 to 6 are plan views illustrating light sources of an immunoassay diagnostic apparatus according to embodiments of the present invention.
Referring to FIG. 3, the
As described above, the light source arrays of the light source layer may each include at least one
4 to 6, light source units of an immunoassay diagnostic apparatus according to other embodiments of the present invention will be described. 4 to 6 are cross-sectional views of a light source unit according to other embodiments of the present invention. Components described through the embodiments of the present invention described above use the same reference numerals and description thereof will be omitted.
The
The
The
The
The
The
7 is a conceptual configuration of a partial configuration including a cross-sectional view taken along line II ′ of a light source unit of the immunoassay diagnostic apparatus of FIG. 5 to describe an operation of the immunoassay diagnostic apparatus according to an embodiment of the present invention. It is also.
Referring to FIG. 7, an operation of some components including a
The light source unit includes a light source layer (see 121 of FIG. 2) and a
A
The light source unit of the immunoassay diagnostic apparatus according to an embodiment of the present invention may adjust the amount of light irradiated onto the
FIG. 8 is a cross-sectional view taken along line II-II ′ of FIG. 6 to describe a light guide plate of a light source unit of an immunoassay diagnostic apparatus according to an embodiment of the present invention.
Referring to FIG. 8, the
Each of the light guide layers 123a, 123b, 123c, and 123d may have a
The
9 is a plan view illustrating a light source unit of an immunoassay diagnostic apparatus according to still another embodiment of the present invention, and FIG. 10 is a cross-sectional view taken along line III-III ′ of FIG. 9.
9 and 10, the
As described above, the light source layer may have two light source arrays disposed between the outer circumferential surface and the inner circumferential surface of one direction of the
When a plurality of light source arrays of the light source layer are provided between the outer circumferential surface and the inner circumferential surface in one direction, the
The
Light provided from the
The
In addition, since the
11 is a cross-sectional view of some schematic components for explaining the operation of the immunoassay diagnostic apparatus according to an embodiment of the present invention.
The
Light is provided from the
The
When the planar uniform light is provided from the
The
When the
The immunoassay apparatus according to the embodiment of the present invention includes a light source unit capable of irradiating light of various intensities or light of a desired intensity with a microfluidic chip, thereby infecting and infecting an infectious disease included in a biological sample. Can be analyzed qualitatively and quantitatively. Accordingly, the immunoassay diagnostic apparatus according to the embodiments of the present invention can analyze the infection and the degree of infection of the infectious disease included in the biological sample more precisely and quantitatively with high efficiency.
In addition, the immunoassay diagnostic apparatus according to the embodiment of the present invention can reduce the size of the immunoassay diagnostic apparatus by miniaturizing the light source unit. In addition, the immunoassay diagnostic apparatus according to the embodiment of the present invention can be mass-produced, thereby reducing the manufacturing cost of the immunoassay diagnostic apparatus.
While the present invention has been described in connection with what is presently considered to be practical exemplary embodiments, it is to be understood that the invention is not limited to the disclosed embodiments, but, on the contrary, It will be understood. It is therefore to be understood that the above-described embodiments are illustrative and non-restrictive in every respect.
100: diagnostic device
110: microfluidic chip
120, 120A, 120B, 120C, 120D, 220: light source
121: light source layer
121s, 221s: light source
122, 222: light guide lens
123, 223: Light guide plate
123a, 123b, 123c, 123d, 223a, 223b, 223c, 223d: light guide layer
1231a, 1231b, 1231c, 1231a: first reflective surface
1232a, 1232b, 1232c, 1232d: second reflective surface
124b and 224b: bottom reflective coating layer
124t, 224t: upper reflective coating layer
125: optical filter 130: sensor unit
131: objective lens 132: beam splitter
133: mirror 134: filter
135: focusing lens 136: confocal aperture
137: detector 140: measuring unit
Claims (25)
A light source unit providing light to the microfluidic chip to generate fluorescence from the fluorescent particle-bioreceptor composite; And
A sensor unit for detecting the fluorescence generated from the microfluidic chip,
The light source unit includes a light source layer and a light guide plate,
The light guide plate includes one or more light guide layers, wherein the light guide layer has a rectangular or more closed polygonal cross-sectional shape having an outer circumferential surface and an inner circumferential surface, wherein the outer circumferential surface and the inner circumferential surface constitute a first reflective surface and a second reflective surface, And
And the light source layer has the same number of light source arrays as the polygon, and the light source array has at least one light source.
The light provided from the light source is:
Is incident on the first reflective surface of the light guide layer,
Light reflected by the first reflecting surface is incident on the second reflecting surface, and
The light reflected by the second reflecting surface is irradiated to the detection unit of the microfluidic chip diagnostic device, characterized in that.
The light source arrangement of the light source layer includes a plurality of light sources,
And the plurality of light sources emit light of different wavelengths.
The light source arrangement of the light source layer includes a plurality of light sources,
The light guide plate is an immunoassay diagnostic apparatus, characterized in that the light guide layer of the same number as the number of the plurality of light sources of the light source array is stacked.
And a plurality of light sources of the light source array of the light source layer inject the light into the first reflective surfaces of different light guide layers of the light guide layers stacked on the light source layers.
An immunoassay diagnostic apparatus further comprising a light guide lens provided between the light source layer and the light guide plate.
The light guide lens comprises at least one selected from a Fresnel lens, a hemispherical lens, a planar lens or a combination thereof.
The light guide lens is a Fresnel lens or a hemispherical lens,
And said light provided from said light source is focused by said light guide lens and is incident on said first reflective surface of said light guide layer.
The light guide lens is a flat lens,
And the light provided from the light source passes through the light guide lens and is incident on the first reflective surface of the light guide layer.
The light guide plate is:
A first reflective coating layer provided on the first surface adjacent to the light source layer; And
An immunoassay diagnostic device further comprising a second reflective coating layer provided on a second side opposite the first side.
The closed polygonal planar cross-sectional shape having the outer circumferential surface and the inner circumferential surface of the light guide layer may be square, regular hexagonal, regular octagonal or circular.
The closed polygonal planar cross-sectional shape is square, regular hexagon or regular octagon,
The number of the light source array of the light source layer is immunoassay diagnostic device, characterized in that 4, 6 or 8, respectively.
The closed polygonal planar form is circular,
The number of the light source array of the light source layer is an immunoassay diagnostic apparatus, characterized in that the value in consideration of the separation distance between the light source array.
And the first and second reflective surfaces of the light guide layer comprise at least one selected from a parabolic mirror, a hemispherical mirror, a flat mirror or a combination thereof.
And the sensing unit of the microfluidic chip has two or more kinds of fluorescent particle-biomaterial complexes.
The biomaterial of the fluorescent particle-biomaterial complex comprises at least one selected from nucleic acids, amino acids, fats, glycoproteins, and antibodies including DNA or RNA.
The biological sample that specifically binds to the fluorescent particle-biomaterial complex is an antigen,
The biological material is an immunoassay diagnostic device, characterized in that the antibody.
The light source is an immunoassay diagnostic device, characterized in that the light emitting diode.
The sensor unit is an immunoassay diagnostic device, characterized in that the silicon detector, a Sisidi photosensitive device or a CMOS photosensitive device.
Immunoassay diagnostic device further comprising a measuring unit for converting the fluorescence sensed by the sensor unit into an electrical signal.
A light source unit providing light to the microfluidic chip to generate fluorescence from the fluorescent particle-bioreceptor composite; And
A sensor unit for detecting the fluorescence generated from the microfluidic chip,
The light source unit includes a light source layer and a light guide plate,
The light guide plate includes one or more light guide layers, wherein the light guide layer has a closed rectangular planar cross section having an outer circumferential surface and an inner circumferential surface, wherein the outer circumferential surface and the inner circumferential surface in one direction constitute a first reflective surface and a second reflective surface. ,
The light guide layer has an inclination that decreases as the widths of the outer circumferential surface and the inner circumferential surface in one direction move away from the light source layer, and
The light source layer has two light source arrays disposed between the outer circumferential surface and the inner circumferential surface in one direction, respectively, wherein the light source array has at least one light source.
The light source arrangement of the light source layer includes a plurality of light sources,
And the plurality of light sources emit light of different wavelengths.
The light source array of the light source layer is provided in plurality between the outer circumferential surface and the inner circumferential surface of the one direction,
The light guide plate is an immunoassay diagnostic device, characterized in that the light guide layer of the same number as the number of the plurality of light source array is stacked.
An immunoassay diagnostic apparatus further comprising a light guide lens provided between the light source layer and the light guide plate.
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Citations (3)
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KR100647317B1 (en) | 2005-02-03 | 2006-11-23 | 삼성전자주식회사 | Optical system for multi-channel fluorescence measurement of microfluidic chip and multi-channel fluorescence sample analyzer |
KR20080105884A (en) * | 2007-06-01 | 2008-12-04 | 삼성전자주식회사 | Fluorescence detecting module for microreaction and fluorescence detecting system having the same |
KR20100033781A (en) * | 2008-09-22 | 2010-03-31 | 한국과학기술원 | Lens with micro-patterned complex surface and making method of the same |
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KR100647317B1 (en) | 2005-02-03 | 2006-11-23 | 삼성전자주식회사 | Optical system for multi-channel fluorescence measurement of microfluidic chip and multi-channel fluorescence sample analyzer |
KR20080105884A (en) * | 2007-06-01 | 2008-12-04 | 삼성전자주식회사 | Fluorescence detecting module for microreaction and fluorescence detecting system having the same |
KR20100033781A (en) * | 2008-09-22 | 2010-03-31 | 한국과학기술원 | Lens with micro-patterned complex surface and making method of the same |
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