KR20170110050A - In-vitro diagnostic apparatus and method - Google Patents

Abstract

The present invention relates to an in vitro diagnostic apparatus and method for diagnosing a user's health condition by analyzing a reaction state of an antigen and an artificial antibody through light reflectance. An apparatus for diagnosing an ex vivo system according to an embodiment of the present invention includes a reaction unit including an artificial antibody that reacts with an antigen of a biomaterial when a user's biomaterial is injected; A light emitting unit for irradiating light with the biomaterial injected into the reaction unit; A light receiving unit receiving light reflected through the biomaterial; And a control unit for analyzing the light received by the light receiving unit to confirm the concentration of the biomaterial and confirming diagnosis information corresponding to the concentration of the biomaterial.

Description

[0001] INVITRO DIAGNOSTIC APPARATUS AND METHOD [0002]

The present invention relates to an in vitro diagnostic apparatus and method for diagnosing a user's health condition by analyzing a reaction state of an antigen and an artificial antibody through light reflectance.

In the recent era of personalized medicine, the in vitro diagnostic industry is in the spotlight. The in vitro diagnostic industry is a field that can be confirmed by a drop, a urine, etc. avoiding various diseases such as diabetes, cholesterol, cancer, etc., and an extracorporeal diagnostic apparatus capable of identifying various diseases while the user is at home or while carrying it has been developed .

Core competencies in the development of in vitro diagnostic devices are the convergence of biotechnology that develops biomaterials (antigens, antibodies, genes, enzymes, etc.) that react with target substances and information technology that develops instruments to measure them. Most in-vitro diagnostics companies in the world are leading the high-value-added knowledge-based industries by creating huge sales and net profits through such technology convergence.

Medical diagnostic kits for in vitro diagnostics have been pointed out as problems of diagnosis efficiency and economical efficiency of product unit price. Currently, in vitro diagnostic tests for most serum protein biomarkers are based on antigen-antibody responses. Antibodies used here must be prepared by injection into animal cell cultures or animals.

In animal cell culture, the process is complicated, time-consuming, costly, and disadvantageous to animals. In addition, animal cell cultures are also susceptible to reproducibility due to the incorporation of various impurities and are under attack from animal protection groups for animal abuse.

SUMMARY OF THE INVENTION It is an object of the present invention to provide an in vitro diagnostic apparatus and method which are inexpensive to manufacture and have improved stability and accuracy.

Other objects and advantages of the present invention will become apparent from the following description, and it will be understood by those skilled in the art that the present invention is not limited thereto. It will also be readily apparent that the objects and advantages of the invention may be realized and attained by means of the instrumentalities and combinations particularly pointed out in the appended claims.

In order to accomplish the above object, according to a first aspect of the present invention, there is provided an in vitro diagnostic apparatus comprising: a reaction unit including an artificial antibody that reacts with an antigen of a biomaterial when a user's biomaterial is injected; A light emitting unit for irradiating light with the biomaterial injected into the reaction unit; A light receiving unit receiving light reflected through the biomaterial; And a controller for analyzing the light received by the light receiving unit to confirm the concentration of the biomaterial and confirming diagnosis information corresponding to the concentration of the biomaterial.

The control unit can confirm the concentration of the biomaterial based on the amount of light received by the light receiving unit.

The reaction unit may include a repebody as the artificial antibody.

The control unit may display the confirmed diagnostic information or transmit the diagnostic information to a designated server.

The light receiving unit may be a CMOS (Complementary Metal-Oxide Semiconductor) sensor.

According to a second aspect of the present invention, there is provided a method for in vitro diagnosing a user's condition in an in vitro diagnostic apparatus, comprising the steps of: irradiating light with a biomaterial of a user reacting with an artificial antibody; Analyzing light reflected through the biomaterial to confirm the concentration of the biomaterial; And confirming diagnostic information corresponding to the concentration of the identified biomaterial.

INDUSTRIAL APPLICABILITY The present invention provides an apparatus and a method for performing in vitro diagnosis using a lipid body as an artificial antibody, thereby lowering the manufacturing cost and solving the problem of loss of humanity caused by animal experiments.

In addition, the present invention has an advantage that accuracy and precision of measurement values can be improved by irradiating light with biomaterial reacting with an artificial antibody and analyzing reflected light to confirm diagnosis information on user's health.

BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate exemplary embodiments of the invention and, together with the description, serve to explain the principles of the invention. And shall not be construed as limited to such matters.
1 is a view showing a configuration of an in vitro diagnostic apparatus according to an embodiment of the present invention.
FIG. 2 is a flowchart illustrating a method for diagnosing a user's health by analyzing light reflected from a biomaterial reacted with an antibody in an in-vitro diagnostic apparatus according to an embodiment of the present invention.

The foregoing and other objects, features and advantages of the present invention will become more apparent from the following detailed description of the present invention when taken in conjunction with the accompanying drawings, in which: There will be. In the following description, well-known functions or constructions are not described in detail since they would obscure the invention in unnecessary detail. Hereinafter, a preferred embodiment of the present invention will be described in detail with reference to the accompanying drawings.

Protein is the substance responsible for most of the in vivo regulation of living organisms. Techniques for understanding the properties of proteins themselves and for studying and controlling the interaction between proteins and other substances have recently become important for the treatment of various diseases.

One of the difficulties in the study and application of these proteins is that it is difficult to produce sufficient amounts of protein.

The difficulty in mass-producing LRR (Family Leukemia-Rich Repeat) family proteins into soluble form in bacteria such as E. coli is presumably due to the sequential hydrophobic residues of the LRR family protein repetitive modules adding to the difficulty of aqueous expression of the protein. The LRR family protein is known to be involved in various physiological processes such as signal transduction, cell cycle control, apoptosis and immune response. If a technology capable of mass-producing such LRR family proteins in a water-soluble host cell such as Escherichia coli can be developed, And the LRR family of proteins in the medical field.

As a result of efforts to develop a technology capable of mass-producing LRR family proteins in a host cell such as Escherichia coli, it has been found that when a part of N-terminal of interlein is fused with LRR family protein, It is possible to produce it. Based on this, an artificial antibody (Lipid body) was developed. The artificial antibody (Lipid body) is an artificial antibody as a new binding material for a target having a low molecular weight.

Kaist and colleagues developed a new protein backbone consisting of a Leuicine-rich repeat (LRR) module and named it RepBody. Because it acts as an anti-muffin antibody, it is very easy to develop as a binding material even for a target with a low molecular weight. The new artificial antibody composed of the LRR module can control the binding area by changing the number of modules. The protein skeleton (ie, Lipid body) composed of the LRR module is superior to the conventional spherical skeleton in terms of stability against heat, pH and protease.

In the present invention, the lipid body is used as an artificial antibody, the antigen is reacted with the antibody, and the reaction state of the antigen and the antibody is analyzed to diagnose the user's health. When the above-mentioned lipid body is used as an artificial antibody, the product production cost can be reduced.

Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings.

1 is a view showing a configuration of an in vitro diagnostic apparatus according to an embodiment of the present invention.

1, an external diagnosing apparatus 100 according to an embodiment of the present invention includes a reaction unit 110, a light emitting unit 120, a light receiving unit 130, a reaction unit 110, a display unit 140 A storage unit 150, and a controller 160.

The reaction unit 110 includes reaction means in which the lipid body is formed as an artificial antibody. As the reaction means, an absorbent sheet, a receiving member, or the like, which is capable of absorbing the biomaterial or accommodating the biomaterial, may be employed. The artificial antibody contained in the reaction unit 110 reacts with the antigen contained in the biomaterial, and the concentration varies depending on the constituent components of the biomaterial. The biomaterial may be blood, but the present invention is not limited thereto, and urine, needle, etc. may be used. The biomaterial injected into the reaction part 110 reacts with the lipid body, which is an artificial antibody, and the biomaterial reacted with the lipid body reflects light emitted from the light emitting part 120. The reaction unit 110 receives light generated from the light emitting unit 120, reflects the light, and provides the light to the light receiving unit 130.

The light emitting unit 120 functions to irradiate the light with the biomaterial injected into the reaction unit 110. The light emitting unit 120 irradiates light having a predetermined wavelength with the biomaterial injected into the reaction unit 110. The light emitting unit 120 may include a light source such as an LED (Light Emitting Diode).

The light receiving unit 130 receives the returning light reflected from the biomaterial. That is, when light emitted from the light emitting unit 120 is irradiated with the biomaterial injected into the reaction unit 110 and the lipid body which is an artificial antibody, the light receiving unit 130 receives light reflected from the biomaterial . The light receiving unit 130 is a CMOS (Complementary Metal-Oxide Semiconductor) -based measurement sensor, and the light receiving unit 130 can receive high-resolution light.

The display unit 140 is a display means such as an LCD (Liquid Crystal Display) or an LED, and displays various information processed by the controller 160.

The storage unit 150 stores diagnostic information for each concentration of biomaterial. The storage unit 150 stores diagnostic information such as a vitamin C or vitamin D level, an antibody level of type A / B / C, blood glucose level, platelet count, and white blood cell count. The storage unit 150 may be recorded in an algorithm necessary for in vitro diagnostic measurement. The storage unit 150 may be a flash memory, a hard disk, a multimedia card micro, a random access memory (RAM), a static random access memory (SRAM) (ROM), an electrically erasable programmable read-only memory (EEPROM), a programmable read-only memory (PROM), or the like.

When the control unit 160 is equipped with a memory function, the control unit 160 may store diagnostic information for each concentration of the biomass. That is, the storage unit 150 is integrated in the controller 160, and the diagnosis information for each concentration of the biomass can be stored in the controller 160. [

The control unit 160 is a processor for controlling each component of the in vitro diagnostic apparatus 100 and outputs various kinds of information to the display unit 140 and controls the light emitting unit 120 and the light receiving unit 130. Particularly, when the biological material is injected into the reaction part 110, the control part 160 controls the light emitting part 120 to irradiate light with the biological material injected into the reaction part 110, and then receives the light from the light receiving part 130 And analyze the concentration of the biomaterial. At this time, the control unit 160 can confirm the concentration of the biomaterial based on the amount of light (that is, the reflected light) received from the light receiving unit 130. In addition, the controller 160 may extract the diagnosis information corresponding to the concentration of the biomaterial as described above from the storage unit 150, and output the diagnostic information to the display unit 140. The control unit 160 may be implemented as a dedicated processor such as an MCU (Micro Controller Unit).

FIG. 2 is a flowchart illustrating a method for diagnosing a user's health by analyzing light reflected from a biomaterial reacted with an antibody in an in-vitro diagnostic apparatus according to an embodiment of the present invention.

Referring to FIG. 2, the reaction unit 110 controls the light emitting unit 120 to emit light (e.g., blood, urine, needle, etc.) 110) to irradiate light having a predetermined wavelength (S203).

In addition, when the user's biomaterial is injected into the reaction part 110 where the lipid body is formed as an artificial antibody, the artificial antibody and the antigen of the biomaterial react with each other. When the artificial antibody and the antigen of the biomaterial react with each other The light emitting unit 120 irradiates light having a certain wavelength with the biomaterial.

Then, the light is reflected by the biomaterial reacted with the artificial antibody, and the light receiving unit 130 receives the light reflected from the biomaterial (S205).

Then, the control unit 160 analyzes the reflected light received by the light receiving unit 130 and confirms the concentration of the biomaterial (S207). The control unit 160 confirms the concentration of the biomaterial based on the amount of the reflected light received by the light receiving unit 130. For example, the controller 160 can confirm the concentration of the biomaterial in inverse proportion to the amount of the reflected light. The control unit 160 pre-loads the formula for confirming the concentration of the biomaterial on the basis of the amount of the reflected light.

Next, the control unit 160 extracts the diagnostic information corresponding to the identified concentration of the biomaterial from the storage unit 150 (S209). The controller 160 stores one of a vitamin C / D value, a platelet value, a white blood cell count, a blood glucose level, and the like in the body as the diagnostic information corresponding to the concentration (i.e., . ≪ / RTI >

Then, the control unit 160 may output the extracted diagnosis information to the display unit 140. FIG.

On the other hand, the in vitro diagnostic apparatus 100 may further include a communication unit (not shown) for communicating with an external network (e.g., the Internet or a mobile communication network). In this case, the in-vitro diagnostic apparatus 100 may transmit the extracted diagnosis information to a designated external server via the network.

INDUSTRIAL APPLICABILITY As described above, the present invention provides an apparatus and a method for performing in vitro diagnosis using a lipid body as an artificial antibody, thereby lowering the manufacturing cost and solving the problem of loss of humanity caused by animal experiments. In addition, the present invention can increase the accuracy and precision of a measurement value by irradiating light with a biomaterial reacting with an artificial antibody and analyzing the reflected light to confirm diagnosis information on the user's health.

Although the operations have been described in a particular order in the figures, it should be understood that such operations are performed in a particular order as shown, or that all described operations are performed to obtain a sequence of sequential orders, or a desired result .

The method of the present invention as described above can be implemented by a program and stored in a computer-readable recording medium (CD-ROM, RAM, ROM, floppy disk, hard disk, magneto optical disk, etc.). Such a process can be easily carried out by those skilled in the art and will not be described in detail.

It will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the spirit or scope of the invention. The present invention is not limited to the drawings.

100: In Vitro Diagnostic Device
110: Reaction part
120:
130:
140:
150:
160:

Claims (2)

A reaction unit including a repeobody reacting with an antigen of the biomaterial when the user's biomaterial is injected;
A light emitting unit for irradiating light with the biomaterial injected into the reaction unit;
A light receiving unit receiving light reflected through the biomaterial; And
And a control unit for analyzing the light received by the light receiving unit to confirm the concentration of the biomaterial and confirming diagnostic information corresponding to the concentration of the biomaterial,
Wherein the control unit confirms the concentration of the biomaterial based on the amount of light received by the light receiving unit. A method for in vitro diagnosis of a user's condition in an in vitro diagnostic device,
Irradiating light with a biomaterial of a user reacting with a repebody;
Analyzing light reflected through the biomaterial to confirm the concentration of the biomaterial; And
And confirming the diagnosis information corresponding to the identified concentration of the biomaterial,
Wherein the step of verifying the concentration of the biomolecule is performed by checking the concentration of the biomaterial based on the amount of the reflected light.

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