KR101254617B1

KR101254617B1 - Diagnostic Apparatus for Immunoassay

Info

Publication number: KR101254617B1
Application number: KR1020100116319A
Authority: KR
Inventors: 이진근; 김희준
Original assignee: 테라웨이브 주식회사
Priority date: 2010-11-22
Filing date: 2010-11-22
Publication date: 2013-04-15
Also published as: KR20120054926A

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

Diagnostic Apparatus for Immunoassay

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 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 diagnostic apparatus 100 includes a microfluidic chip 110, a light source unit 120, a sensor unit 130, and a measurement unit 140.

The microfluidic chip 110 may include a detector having fluorescent particle-biomaterial complexes for detecting an infectious disease included in a biological sample. The fluorescent particle-biomaterial complex may be specifically combined with an infectious disease included in a biological sample to form a fluorescent particle-biomaterial complex.

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 microfluidic chip 110 may have two or more kinds of fluorescent particle-biomaterial complexes. Accordingly, the microfluidic chip 110 may be used to simultaneously detect a plurality of infectious diseases included in the biological sample.

The microfluidic chip 110 may be capable of various operations, such as mixing, separating, and replacing a biological sample in a fluid form, that is, a biological sample such as blood, and the like, moving, stopping, changing a speed, and other fluid such as a test solution. The microfluidic chip 110 is a kind of polymer material used as a material, a kind of fluid used for detection, and a contact angle, such as a width, depth, and length of a fluid channel, which are variables that may affect the flow of the fluid. It may be implemented in consideration of such. In addition, the microfluidic chip 110 may be implemented in consideration of variables such as types and methods of pumps and valves for efficient transport of fluids, and locations of the microfluidic chips 110.

The biological sample collected from the infected patient to be diagnosed is injected into the microfluidic chip 110 without a pretreatment process, and the biological sample and the reaction solution mixture move in the fluid channel while infecting the infectious disease and fluorescent particle-biomaterial complex included in the biological sample. The physical conjugation of is formed.

The light source unit 120 may provide light to the microfluidic chip 110. The light provided by the light source 120 may excite the fluorescent particles of the fluorescent particle-biobinding material complex of the microfluidic chip 110 to generate fluorescence. The light source unit 120 may include a light source layer 121 of FIG. 2 and a light guide plate (see 123 of FIG. 2). The light source layer may include a light source (see 121s of FIGS. 3 to 7) which is a high brightness light emitting diode (LED).

An optical filter 125 may be provided between the light source unit 120 and the microfluidic chip 110 to provide single wavelength light to the microfluidic chip 110. The multi-wavelength light generated from the light source unit 120 may be changed into a specific single-wavelength light while passing through the optical filter 125. The optical filter 125 may be in the form of a chopper. That is, various types of optical filters 125 may be provided in one chopper. Accordingly, various specific single wavelength light may be provided to the microfluidic chip 110.

When the microfluidic chip 130 has two or more kinds of fluorescent particle-biomaterial complexes, different fluorescences may be generated by excitation of fluorescent particles of two or more kinds of fluorescent particle-biomaterial complexes. Accordingly, fluorescence may occur for each of the plurality of infectious diseases included in the biological sample.

As described above, the sensor unit 130 may detect fluorescence generated by excitation of the fluorescent particles of the fluorescent particle-biobinding material complex of the microfluidic chip 110. The sensor unit 130 may be a silicon detector, a CCD photosensitive device, or a CMOS photosensitive device. The sensor unit 130 may maintain a close distance to the microfluidic chip 110 to sense fluorescent energy emitted radially without a specific direction, and may have a shape surrounding three surfaces. In addition, the sensor unit 130 may include a high sensitivity detector (see 137 of FIG. 11).

The measurement unit 140 may convert the fluorescent energy detected by the sensor unit 130 into an electrical signal. The electrical signal may be in the form of a current peak. The measurement unit 140 may accumulate the fluorescent energy detected by the sensor unit 130 by switching electrical signals. Since the measuring unit 140 accumulates and measures an electrical signal in the form of a current peak, the detection sensitivity to fluorescence generated by excitation of the fluorescent particles of the fluorescent particle-bio-combination material complex of the microfluidic chip 110 may be increased. have.

When the microfluidic chip 110 has two or more kinds of fluorescent particle-biomaterial complexes, different fluorescences may be generated by excitation of the fluorescent particles of each of the two or more kinds of fluorescent particle-biomaterial complexes. Each of these different fluorescence energies can be converted into electrical signals in the form of different current peaks. Accordingly, an electrical signal including current peaks for each of the plurality of infectious diseases included in the biological sample can be measured.

The measurement unit 140 may analyze the electrical signals in the form of current peaks and analyze the types of infectious diseases included in the biological samples corresponding to the current peaks and the extent of the infectious diseases. Accordingly, qualitative and quantitative analysis of each of the plurality of infectious diseases included in the biological sample may be possible. In addition, it may be possible to simultaneously analyze a plurality of infectious diseases included in a biological sample. Accordingly, an immunoassay diagnostic apparatus 100 capable of simultaneously and qualitatively and quantitatively confirming whether each of the plurality of infectious diseases included in the biological sample is infected and the degree of infection may be provided.

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 light source unit 120 includes a light source layer 121 and a light guide plate LGP 123. The light guide plate 123 may include at least one light guide layer. The light guide layer may have a closed polygonal planar cross-sectional shape having a rectangular shape having an outer circumferential surface and an inner circumferential surface. The outer circumferential surface and the inner circumferential surface of the light guide layer may be a first reflective surface (see 1231a, 1231b, 1231c or 1231d in FIGS. 7 and 8) and a second reflective surface (see 1232a, 1232b, 1232c or 1232d in FIGS. 7 and 8). have. When the outer circumferential surface of the light guide layer is the first reflective surface, the inner circumferential surface may be the second reflective surface. On the other hand, when the inner circumferential surface of the light guide layer is the first reflective surface, the outer circumferential surface may be the second reflective surface.

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 light source layer 121 may have the same number of light source arrays as the polygons of the light guide layer having a closed polygonal planar cross-sectional shape. The light source array may have at least one light source (see 121s of FIGS. 3 to 7).

When the light source array of the light source layer 121 includes a plurality of light sources, the light guide plate 123 may have a shape in which the same number of light guide layers as the number of the light sources of the light source array are stacked. In this case, the plurality of light sources of the light source array may inject light into first reflective surfaces of different light guide layers of the light guide layers stacked.

The light guide lens 122 may be further provided between the light source layer 121 and the light guide plate 123. The number of light guide lenses 122 may be equal to the number of light sources included in the light source layer 121. That is, one light guide lens 122 may be provided between the light source and the light guide plate 123. The light guide lens may include at least one selected from a fresnel lens, a plano-convex lens, a flannel or planar lens, or a combination thereof. When the light guide lens 122 is a Fresnel lens or a hemisphere lens, light provided from the light source may be focused by the light guide lens 122 and incident on the first reflective surface of the light guide layer. Alternatively, the light guide lens 122 may be incident to the first reflective surface of the light guide layer.

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 light guide plate 123 includes an upper reflective coating layer (see 124t in FIG. 8) provided on the first surface adjacent to the light source layer 121 and a lower reflective coating layer provided on the second surface opposite to the first surface ( 8) may further include 124b of FIG. 8. The upper and lower reflective coating layers may be layers having one side reflective properties. That is, the upper and lower reflective coating layers may have reflective characteristics on surfaces facing the first and second surfaces of the light guide plate 123. The upper and lower reflective coating layers are applied when the light provided from the light source is incident on the first reflective surface of the light guide layer of the light guide plate 123, when reflected by the first reflective surface of the light guide layer, and on the second reflective surface of the light guide layer. When reflected by the light guide plate 123, the light may be prevented from escaping to the outside of the light guide plate 123. The light guide efficiency of the light guide plate 123 may be increased by the upper and lower reflective coating layers.

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 light guide plate 123 of the light source unit 120A according to the exemplary embodiment of the present invention has a light guide layer having a closed rectangular planar cross section having an inner circumferential surface and an outer circumferential surface. Preferably, the light guide layer according to the embodiment of the present invention may have a closed square flat cross-sectional shape. In this case, the number of light source arrays of the light source layer (see 121 of FIG. 2) may be four equal to the total number of sides of the quadrangle.

As described above, the light source arrays of the light source layer may each include at least one light source 121s. Accordingly, as shown in the drawing, when the light source arrays each include four light sources 121s, the light guide plate 123 may have a shape in which four light guide layers are stacked.

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 light source unit 120B according to another embodiment of the present invention described with reference to FIG. 4 is different from the light source unit 120A according to the embodiment of the present invention. The light source layer and the light guide plate 123 have different shapes. It is.

The light guide plate 123 of the light source unit 120B has a light guide layer of a closed hexagonal planar cross section having an inner circumferential surface and an outer circumferential surface. Preferably, the light guide layer according to the embodiment of the present invention may have a closed regular hexagonal flat cross-sectional shape. In this case, the number of light source arrays of the light source layer (see 121 of FIG. 2) may be six equal to the total number of sides of the hexagon.

The light source unit 120C according to another embodiment of the present invention described with reference to FIG. 5 is different from the light source unit 120A according to the embodiment of the present invention. The light source layer and the light guide plate 123 have different shapes. It is.

The light guide plate 123 of the light source unit 120C has a light guide layer in the form of a closed octagonal flat cross section having an inner circumferential surface and an outer circumferential surface. Preferably, the light guide layer according to the embodiment of the present invention may have a closed square octagonal cross-sectional shape. In this case, the number of light source arrays of the light source layer (see 121 of FIG. 2) may be six equal to the total number of sides of the octagon.

The light source unit 120D according to another embodiment of the present invention described with reference to FIG. 6 is different from the light source unit 120A according to the embodiment of the present invention described above, in which the light source layer and the light guide plate 123 are different from each other. It is.

The light guide plate 123 of the light source unit 120D has a light guide layer having a closed circular planar cross section having an inner circumferential surface and an outer circumferential surface. In this case, the number of light source arrays of the light source layer (see 121 of FIG. 2) may be a maximum value considering the minimum distance required between the light source arrays.

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 microfluidic chip 110 and a light source unit (see 120A, 120B, 120C or 120D of FIGS. 3 to 6) may be performed in an immunoassay diagnostic apparatus (see 100 of FIG. 1). It is a conceptual diagram for explaining.

The light source unit includes a light source layer (see 121 of FIG. 2) and a light guide plate 123. The light source layer may have a plurality of light source arrays, and each of the plurality of light source arrays may have a plurality of light sources 121s. Here, as illustrated, the case where the light source array has four light sources 121s will be described as an example. The light guide plate 123 may have a shape in which four light guide layers 123a, 123b, 123c, and 123d are stacked. Each of the light guide layers 123a, 123b, 123c, and 123d may have a first reflection surface 1231a, 1231b, 1231c, and 1231d and a second reflection surface 1232a, 1232b, 1232c, and 1232d. Here, as shown, the outer circumferential surface of the light guide layers 123a, 123b, 123c, and 123d is the first reflection surface 1231a, 1231b, 1231c, and 1231d, and the inner circumferential surface is the second reflection surface 1232a, 1232b, 1232c. And 1232d) will be described as an example.

A light guide lens 122 may be provided between each of the light sources 121s and the light guide plate 123. The light sources 121s are formed of different light guide layers 123a, 123b, 123c, or 123d of the first to fourth light guide layers 123a, 123b, 123c, and 123d stacked through the light guide lenses 122, respectively. Light can be incident on one reflective surface 1231a, 1231b, 1231c, or 1231d, respectively. Light incident on the first reflective surface 1231a, 1231b, 1231c, or 1231d is reflected by the first reflective surface 1231a, 1231b, 1231c, or 1231d, and is incident on the second incident surface 1232a, 1232b, 1232c, or 1232d. The light incident on the second incidence surface 1232a, 1232b, 1232c, or 1232d may be reflected by the second incidence surface 1232a, 1232b, 1232c, or 1232d to be irradiated to the sensing unit of the microfluidic chip 110. . That is, light provided from each light source 121s may be irradiated to the sensing unit of the microfluidic chip 110 through the first, second, third, or fourth light guide layers 123a, 123b, 123c, or 123d. .

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 microfluidic chip 110 by adjusting the number of light sources 121s. In addition, as the plurality of light sources 121s of the light source unit emit light having different wavelengths, the microfluidic chip 110 may simultaneously irradiate light having various wavelengths.

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 light guide plate 123 of the light source unit 120 (see 120 of FIG. 1 or 120D of FIG. 6) of the immunoassay apparatus 100 (see 100 of FIG. 1) may include light guide layers 123a, 123b, 123c, and 123d. It may have a stacked form.

Each of the light guide layers 123a, 123b, 123c, and 123d may have a first reflection surface 1231a, 1231b, 1231c, and 1231d and a second reflection surface 1232a, 1232b, 1232c, and 1232d. Here, as shown, the outer circumferential surface of the light guide layers 123a, 123b, 123c, and 123d is the first reflection surface 1231a, 1231b, 1231c, and 1231d, and the inner circumferential surface is the second reflection surface 1232a, 1232b, 1232c. And 1232d). On the other hand, the inner circumferential surface of the light guide layers 123a, 123b, 123c, and 123d may be the first reflective surface, and the inner circumferential surface may be the second reflective surface.

The light guide plate 123 further includes an upper reflective coating layer 124t provided on the first side adjacent to the light source layer (see 121 in FIG. 2) and a lower reflective coating layer 124b provided on the second side opposite to the first side. It may include. The upper and lower reflective coating layers 124t and 124b may be layers having one surface reflective property. That is, the upper and lower reflective coating layers 124t and 124b may have reflection characteristics on surfaces facing the first and second surfaces of the light guide plate 123. The upper and lower reflective coating layers 124t and 124b may have light provided from a light source (see 121s of FIGS. 3 to 7) and the first reflective surfaces of the light guide layers 123a, 123b, 123c and 123d of the light guide plate 123. When incident on (1231a, 1231b, 1231c, 1231d), when reflected by the first reflective surfaces 1231a, 1231b, 1231c, 1231d of the light guide layers 123a, 123b, 123c, 123d, and When reflected by the second reflecting surfaces 1232a, 1232b, 1232c, and 1232d of the fields 123a, 123b, 123c, and 123d, the light may be prevented from escaping to the outside of the light guide plate 123. The light guide efficiency of the light guide plate 123 may be increased by the upper and lower reflective coating layers 124t and 124b.

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 light source unit 220 may include a light source layer (see 121 of FIG. 2) and a light guide plate 223. The light guide plate 223 may include at least one light guide layer 223a, 223b, 223c, or 223d. The light guide layer 223a, 223b, 223c or 223d may have a closed rectangular planar cross-sectional shape having an outer circumferential surface and an inner circumferential surface. Preferably, the light guide layer 223a, 223b, 223c or 223d according to another embodiment of the present invention has a closed rectangular planar cross section, and has a flat cross section in which the width in one direction is larger than the width in the other direction perpendicular to the same. Can be. In this case, the number of light source arrays of the light source layer may be two disposed between the outer circumferential surface and the inner circumferential surface of one direction of the light guide layer 223a, 223b, 223c or 223d, respectively. The outer circumferential surface and the inner circumferential surface in one direction may constitute the first reflective surface and the second reflective surface. When the outer circumferential surface of the light guide layer 223a, 223b, 223c, or 223d in one direction is the first reflective surface, the inner circumferential surface may be the second reflective surface. On the other hand, when the inner circumferential surface of the light guide layer 223a, 223b, 223c or 223d is the first reflective surface, the outer circumferential surface may be the second reflective surface. The light guide layers 223a, 223b, 223c, or 223d may have a slope 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.

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 light guide layer 223a, 223b, 223c, or 223d in the form of a closed rectangular planar cross section. The light source array may have at least one light source 221s. When the light source arrangement of the light source layer includes a plurality of light sources 221s, the plurality of light sources 221s may emit light having different wavelengths.

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 light guide plate 223 is formed by stacking the same number of light guide layers 223a, 223b, 223c, and 223d as the number of light source arrays. It may be in the form. In this case, the plurality of light source arrays may inject light into the first reflective surfaces of the different light guide layers 223a, 223b, 223c, or 223d of the light guide layers 223a, 223b, 223c, and 223d. Accordingly, as shown, when the light source layer is composed of four light source arrays, the light guide plate 223 may have a shape in which four light guide layers 223a, 223b, 223c, and 223d are stacked.

The light guide lens 222 may be further provided between the light source layer and the light guide plate 223. The number of light guide lenses 222 may be equal to the number of light source arrays included in the light source layer. That is, one light guide lens 222 may be provided between the light source 221s and the light guide plate 223. The light guide lens may include at least one selected from a Fresnel lens, a hemispherical lens, a planar lens, or a combination thereof. When the light guide lens 222 is a Fresnel lens or a hemisphere lens, light provided from the light source may be focused by the light guide lens 222 and incident on the first reflective surface of the light guide layer 223a, 223b, 223c, or 223d. . Alternatively, the light penetrating the light guide lens 222 may be incident on the first reflective surface of the light guide layer 223a, 223b, 223c, or 223d.

Light provided from the light source 221s is incident on the first reflective surface of the light guide layer 223a, 223b, 223c or 223d, and the light reflected by the first reflective surface is incident on the second reflective surface, and the second half The light reflected by the slope may be irradiated to the sensing unit of the microfluidic chip (see 110 of FIG. 1) of the immunoassay diagnostic apparatus (see 100 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 light guide plate 223 may further include an upper reflective coating layer 224t provided on the first side adjacent to the light source layer and a lower reflective coating layer 224b provided on the second side opposite to the first side. The upper and lower reflective coating layers 224b and 224t may be layers having one surface reflective property. That is, the upper and lower reflective coating layers 224b and 224t may have reflection characteristics on surfaces facing the first and second surfaces of the light guide plate 223. The upper and lower reflective coating layers 224b and 224t are formed when the light provided from the light source 221s is incident on the first reflective surface of the light guide layer 223a, 223b, 223c or 223d of the light guide plate 223. , When reflected by the first reflective surface of 223b, 223c or 223d, and when reflected by the second reflective surface of the light guide layer 223a, 223b, 223c or 223d, the light is directed out of the light guide plate 223 It may be to prevent the escape. The light guide efficiency of the light guide plate 223 may be increased by the upper and lower reflective coating layers 224b and 224t.

In addition, since the light guide layers 223a, 223b, 223c, or 223d have 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, the light provided from the light source 221s receives the light guide layers 223a, 223b. , 223c or 223d) may be focused at any point inside the inner circumferential surface. Accordingly, the degree of concentration of the amount of light irradiated onto the microfluidic chip can be further increased.

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 microfluidic chip 110 includes fluorescent particle-biobinding complexes formed by specifically combining an infectious disease included in a biological sample with fluorescent particle-biological complexes. The microfluidic chip 110 may include two or more kinds of fluorescent nanoparticle-biobound material complexes.

Light is provided from the light source unit 120. The light provided from the light source unit 120 is incident to the fluorescent particle-bio-combination complexes of the microfluidic chip 110 through a beam splitter 132 of the sensor unit 130. The light incident on the fluorescent particle-bio binder material complexes of the microfluidic chip 110 may excite the fluorescent particles of the fluorescent particle-bio binder material complex of the microfluidic chip 110 to generate fluorescence. Fluorescence is radiated radially by excitation of the fluorescent particles of the fluorescent particle-biobinding material complex of the microfluidic chip 110. The radially emitted fluorescence passes through the objective lens 131 and is transmitted to the mirror 133 in the form of a fluorescence beam. The fluorescent beam reflected by the mirror 133 passes through the filter 134 and a specific single wavelength fluorescent beam is delivered to the focusing lens 135. The specific single wavelength fluorescent beam is converged by the focusing lens 135, diverges while passing through a confocal pinhole 136 and is detected by the detector 137 of the sensor unit 130.

The sensor unit 130 may use a time difference detection technique to avoid energy disturbance caused by the light provided from the light source unit 120. In addition, the sensor unit 130 may use scattered light processing, noise reduction, and pattern recognition techniques for the detected fluorescent beam.

When the planar uniform light is provided from the light source unit 120 to the microfluidic chip 110, the fluorescence generated by excitation of the fluorescent particles of the fluorescent particle-biocombinator composite is in two-dimensional form. 137).

The filter 134 may be in the form of a chopper. That is, various types of filters 134 may be provided in one chopper. Accordingly, various specific single wavelength fluorescent beams may be detected by the detector 137 of the sensor unit 130.

When the microfluidic chip 110 has two or more kinds of fluorescent particle-biomaterial complexes, different fluorescences may be generated by excitation of the fluorescent particles of each of the two or more kinds of fluorescent particle-biomaterial complexes. Since the different fluorescences have different wavelengths, they may be separately detected by the detector 137 of the sensor unit 130. Accordingly, the fluorescence of each of the plurality of infectious diseases included in the biological sample can be detected.

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

For detection of a biological sample, the microfluidic chip comprising a sensing unit having at least one fluorescent particle-biomaterial complex that specifically binds to the biological sample to form a fluorescent particle-biobinding complex;
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 method of claim 1,
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 method of claim 1,
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 method of claim 1,
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.

5. The method of claim 4,
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.

The method of claim 1,
An immunoassay diagnostic apparatus further comprising a light guide lens provided between the light source layer and the light guide plate.

The method according to claim 6,
The light guide lens comprises at least one selected from a Fresnel lens, a hemispherical lens, a planar lens or a combination thereof.

The method according to claim 6,
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 method according to claim 6,
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 method of claim 1,
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 method of claim 1,
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 method of claim 1,
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 method of claim 1,
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.

The method of claim 1,
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.

The method of claim 1,
And the sensing unit of the microfluidic chip has two or more kinds of fluorescent particle-biomaterial complexes.

delete

The method of claim 1,
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 method of claim 1,
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 method of claim 1,
The light source is an immunoassay diagnostic device, characterized in that the light emitting diode.

The method of claim 1,
The sensor unit is an immunoassay diagnostic device, characterized in that the silicon detector, a Sisidi photosensitive device or a CMOS photosensitive device.

The method of claim 1,
Immunoassay diagnostic device further comprising a measuring unit for converting the fluorescence sensed by the sensor unit into an electrical signal.

For detection of a biological sample, the microfluidic chip comprising a sensing unit having at least one fluorescent particle-biomaterial complex that specifically binds to the biological sample to form a fluorescent particle-biobinding complex;
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.

23. The method of claim 22,
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.

23. The method of claim 22,
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.

23. The method of claim 22,
An immunoassay diagnostic apparatus further comprising a light guide lens provided between the light source layer and the light guide plate.