KR101918115B1 - device for separating compounds and chemiluminescent immunoassay device using the same - Google Patents

Abstract

TECHNICAL FIELD The present invention relates to a compound separation apparatus and a chemiluminescence immunoassay apparatus using the compound separation apparatus. The compound separation apparatus disclosed in this specification includes a mount, a flocculation section, and a non-compound separation section to separate do. The chemiluminescent immunoassay apparatus includes the compound separation apparatus, and can measure the amount of the specific component contained in the blood or the serum sample, including the immobilization unit and the donor supply unit illuminant supply unit and the light source measurement unit.

Description

TECHNICAL FIELD The present invention relates to a compound separation apparatus and a chemiluminescent immunoassay device using the same,

TECHNICAL FIELD The present invention relates to a compound separation apparatus and a chemiluminescence immunoassay apparatus using the compound separation apparatus. More particularly, the present invention relates to a compound separation apparatus capable of separating and extracting only specific components contained in a sample using magnetism, To a chemiluminescent immunoassay device capable of measuring the content of a specific component contained in the blood or serum of a human body through chemiluminescence.

In the field of clinical examination, a technique of separating a compound is used to diagnose various diseases by using a biological sample (blood, urine, etc.). As such a diagnostic method, various measurement methods have been developed and used. Representative methods of such a measurement method include biochemical assay using an enzyme reaction or immunoassay using an antigen-antibody reaction. In recent years, it is required to precisely measure components in living body samples, and immunoassay methods using an antigen-antibody reaction with high specificity are widely used.

Immunoassays include radioimmunoassay (RIA) for detecting signals using radioactive isotopes according to their detection principles and methods, enzyme-linked immunosorbent assay (ELISA) using signal amplification using enzymes, (EIA), fluorescence antibody technique (FA), and chemiluminescence immunoassay (CLIA) using chemiluminescence. In addition, the use of labeling substances It can be classified in various ways depending on the method or substrate type.

Among the various immunoassays, enzyme immunoassay has excellent sensitivity, specificity, rapidity and reproducibility of reactions, and has advantages of versatility that can be used for detecting various kinds of antigens and antibodies by the same manipulation when different antigens or antibodies are used . Enzyme immunoassays can be subdivided into three categories: Direct ELISA, Indirect ELISA, and Sandwich ELISA, depending on how the antibody is used.

Specifically, in the direct enzyme immunoassay, when an enzyme linked to an enzyme immobilized on a solid surface is bound (an enzyme-linked Antibody), the enzyme catalyzes the substrate reaction to generate a signal. In indirect enzyme immunoassay, the primary antibody binds specifically to the antigen, and the secondary antibody to which the enzyme is attached recognizes and binds to the main antibody. In this state, the enzyme that is connected to the secondary antibody catalyzes the reaction of the substrate. Finally, sandwich enzyme immunoassay, which is the most widely used form, uses two antibodies with different epitopes for one antigen to be detected and shows high selectivity for the antigen to be detected, Is also being used a lot.

Korean Patent No. 10-1495665 (published on Feb. 26, 2015) discloses a method comprising: a first moving step of moving a magnetic binding body including a magnetic bead and a first antibody to a first well containing a sample using a magnet; A first binding step in which the magnetic binding substance and the target antigen in the sample bind to each other to form a magnetic binding substance-antigen complex; a second transfer step of moving the magnetic binding substance-antigen complex to a second well containing a marker using a magnet; A second binding step of binding the magnetic binding body-antigen complex to the marker to form a magnetic binding body-antigen-marker complex, and a detecting step of detecting the magnetic binding body-antigen-marker complex. .

In addition, it is possible to detect the fluorescence of a magnet portion constituted by a well portion including a well to which a sample is dispensed, a magnetic portion composed of a magnetic bar and a magnetic bar cap capable of covering the sample, and a marker bound to the specimen in the sample And a moving unit capable of moving the well to the fluorescence detecting unit.

Korean Patent No. 1991-0008409 (published May 31, 1991) discloses a container having an opening, a solid porous element in the container, a porous absorbent material in the container chemically inert to the chemiluminescent reaction, Means for uniformly distributing the chemiluminescent solution to the porous element to cause the chemiluminescent reaction reaction adjacent to the opening; and photo-detection means adjacent the opening, wherein the porous element is configured such that the chemiluminescent portion comprises the solid porous element Which prevents the migration of the chemiluminescent analyte while permitting the passage of other reaction components of the chemiluminescent analyte.

Korean Patent Laid-Open Publication No. 10-2009-0033694 (published on Apr. 06, 2009) discloses a method for collecting the antigen with magnetic macroparticles (MMPs) in which a primary antibody specific for the antigen to be analyzed is immobilized (Hereinafter referred to as " SPs ") having a cascade reaction initiator and a secondary antibody specific to the antigen immobilized on the captured antigen of step 1), and converting the resultant into an active enzyme by the cascade reaction initiator The method comprising the steps of treating a precursor enzyme and a signal-forming substrate specific to the active enzyme, and measuring a change in the formation signal.

The compound separation apparatus disclosed in this specification intends to provide a compound separation apparatus capable of precisely separating a compound and a non-compound using magnetic property in a short time.

To provide a chemiluminescence immunoassay device capable of measuring the amount of a specific component contained in the blood or serum of a human body in a short time by supplying only one or more sample containers storing the blood or serum of the human body using the compound separation apparatus do.

The present invention also provides a chemiluminescent immunoassay device capable of early diagnosis of pancreatic cancer by measuring chemiluminescence of pure antigen through a conjugate which reacts with CA-19-9 and Glypican-1 antigen.

In one embodiment, a compound separation apparatus and a chemiluminescent immunoassay using the same are disclosed.

The compound separation apparatus comprises a mount for mounting a sample container in which a compound having magnetic properties and a compound having no magnetic property are placed, and a flocculating portion disposed on a side surface of the sample container for flocculating the compound and a non- Wherein the compound and the non-compound are produced through a reaction between a sample containing an antigen and a conjugate which reacts with the antigen, wherein the conjugate comprises an antibody reactive with the antigen and a magnetic substance conjugated with the antibody .

The coagulation portion includes a permanent magnet for cohesion of the coupling body received in the sample vessel and a magnetic force transfer portion for moving the permanent magnet close to the sample vessel.

Further comprising another flocculant disposed on the other side of the sample vessel in which the flocculating section is not disposed, and a control section for causing each of the flocculating sections to operate individually.

The non-organic compound separating portion is disposed at a position outside the coagulated position of the organic substance in the sample container and is connected to the separating and suction portion for sucking the non-organic compound, and moves the separating and suction portion to the inside and the outside of the sample container And a separating and moving part.

The non-compound separating portion includes a washing solution supplying portion for supplying the washing solution into the sample container.

The non-compound separating unit includes a washing liquid moving part that moves the washing liquid supplying part into the sample container, and allows the washing liquid to be injected to a position where the coupling body is coagulated.

The non-organic compound separating portion includes a washing liquid guide connected to the washing liquid supplying portion and having an upper surface inclined in the direction of the inner surface of the sample container opposite to the aggregating portion.

The chemiluminescent immunoassay apparatus comprises a compound separating apparatus and a mounting section for moving the mounting section, a light emitting body supplying section disposed on a moving path of the mounting section for supplying a chemiluminescent substance to the sample container provided by the compound separating apparatus, And a light source measuring unit arranged on the moving path of the part to measure light emitted from the sample container to which the chemiluminescent material is supplied, wherein the compound separating apparatus is disposed on a moving path of the mounting unit, Wherein the sample container accommodated in the sample container is accommodated in the sample container and the sample container in which the sample is accommodated is provided to the combination container supply unit through the accommodation moving unit, By supplying the coupling body to the sample vessel to be provided, And preparing the sample container in which the compound and the non-compound are contained.

Wherein the stationary portion includes a stationary plate member connected to the stationary movable portion and at least one sample container hole arranged in a circular shape in which the sample container is inserted into the stationary plate member and the stationary moving portion is connected to the stationary portion, And a driving device for rotating the motor.

Wherein the coupling member supply unit includes a coupling member container in which the coupling member is accommodated and a coupling pump connected to the coupling member container for sucking and injecting the coupling member, a coupling member injection nozzle connected to the coupling member pump for guiding the coupling member into the sample container, And a coupling member injection nozzle moving part for moving the coupling member injection nozzle into and out of the sample container.

Wherein the flocculating portion is disposed below the cradle, and the non-compound separating portion is disposed on an upper portion of the cradle corresponding to the flocculating portion.

Wherein the light emitter supply part is disposed on the upper part of the cradle, and the light source measuring part is disposed below the cradle opposite to the light emitter supply part.

The antigen is CA-19-9 and Glypican-1, and the sample is a fluorescent conjugate comprising a fluorescent substance bound to an antibody reactive with CA-19-9 and another fluorescent substance conjugated with an antibody reactive with Glypican-1 Wherein the complex comprises a magnetic substance bound to an antibody reactive with CA-19-9 and a magnetic substance bound to an antibody reactive with Glypican-1, wherein the two types of fluorescent substances of the fluorescent substance have different optical wavelengths Wherein the chemiluminescent material and the two kinds of phosphors react with each other to generate light of different wavelengths, hereinafter referred to as a first wavelength and a second wavelength, and the light source measuring unit is disposed between the sample containers, A first light measuring sensor and a second light measuring sensor which are arranged to face the first light measuring sensor and can photograph the light of the first wavelength and the light of the second wavelength, Approaching the container It includes moving the optical sensor such that the mobile unit for.

The compound separation apparatus disclosed in this specification can easily separate a compound and a non-compound from each other in a sample container through an aggregation portion, and can effectively separate a compound and a non-compound in a short time. Further, the cohesive force and cohesion and separation of the compound can be repeated through the coagulated portion, and the non-coagulated compound can be separated in a shorter time in a precise manner.

The chemiluminescence immunoassay apparatus using the compound separation apparatus can measure the amount of a specific component contained in blood or serum of a human body by supplying only one or more sample containers containing blood or serum of the human body.

Furthermore, by being able to measure the chemiluminescence of pure antigens through a conjugate that reacts with CA-19-9 and Glypican-1 antigen, it is possible to diagnose pancreatic cancer early.

The foregoing provides only a selective concept in a simplified form as to what is described in more detail hereinafter. The present disclosure is not intended to limit the scope of the claims or limit the scope of essential features or essential features of the claims.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a diagram showing an embodiment of a compound separation apparatus disclosed in the present specification. FIG.
Fig. 2 is a view showing the action relationship of the aggregated portion. Fig.
3 is a view showing another embodiment of the coagulating portion.
Fig. 4 is a diagram showing another functional relationship of the flocculating portion. Fig.
5 is a view showing the separation suction part.
6 is a view showing another embodiment of the non-compound separating portion.
FIG. 7 is a view showing an operating relationship of the non-compound separation section. FIG.
FIG. 8 is a view showing another embodiment of the non-compound separation section. FIG.
9 is a diagram illustrating an embodiment of the chemiluminescent immunoassay device disclosed herein.
10 is a diagram showing another embodiment of the chemiluminescent immunoassay apparatus disclosed in the present specification.
11 is a view showing a combination supply unit, a light emitting unit supply unit, and a light source measurement unit disclosed in this specification.

Hereinafter, embodiments disclosed in this specification will be described in detail with reference to the drawings. Like reference numerals in the drawings denote like elements, unless the context clearly indicates otherwise. The exemplary embodiments described above in the detailed description, the drawings, and the claims are not intended to be limiting, and other embodiments may be utilized, and other variations are possible without departing from the spirit or scope of the disclosed technology. Those skilled in the art will appreciate that the components of the present disclosure, that is, the components generally described herein and illustrated in the figures, may be arranged, arranged, combined, or arranged in a variety of different configurations, all of which are expressly contemplated, It can be easily understood that a part is formed. In the drawings, the width, length, thickness or shape of an element, etc. may be exaggerated in order to clearly illustrate the various layers (or films), regions and shapes.

When a component is referred to as being "positioned" to another component, it may include a case where the component is directly disposed on the other component as well as a case where an additional component is interposed therebetween.

When one component is referred to as being "connected" to another component, it may include a case where the one component is directly connected to the other component as well as a case where additional components are interposed therebetween.

When one element is referred to as being "formed" to another element, it may include the case where the one element is formed directly on the other element, as well as the case where additional elements are interposed therebetween.

When one element is referred to as being "coupled" to another element, it may include the case where the one element is directly coupled to the other element as well as the case where additional elements are interposed therebetween.

The description of the disclosed technique is merely an example for structural or functional explanation and the scope of the disclosed technology should not be construed as being limited by the embodiments described in the text. That is, the embodiments are to be construed as being variously embodied and having various forms, so that the scope of the rights of the disclosed technology should be understood to include equivalents capable of realizing the technical ideas.

It is to be understood that the singular " include " or " have ", if any, Or combinations thereof, and does not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, or combinations thereof.

Unless defined otherwise, all terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the disclosed technology belongs. Commonly used dictionary defined terms should be interpreted to be consistent with the meanings in the context of the related art and can not be interpreted as having ideal or overly formal meaning unless explicitly defined in the present application.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a diagram showing an embodiment of a compound separation apparatus disclosed in the present specification. FIG. Fig. 2 is a view showing the action relationship of the aggregated portion. Fig. 3 is a view showing another embodiment of the coagulating portion. Fig. 4 is a diagram showing another functional relationship of the flocculating portion. Fig. 5 is a view showing the separation suction part. 6 is a view showing another embodiment of the non-compound separating portion. FIG. 7 is a view showing an operating relationship of the non-compound separation section. FIG. FIG. 8 is a view showing another embodiment of the non-compound separation section. FIG. 9 is a diagram illustrating an embodiment of the chemiluminescent immunoassay device disclosed herein. 10 is a diagram showing another embodiment of the chemiluminescent immunoassay apparatus disclosed in the present specification. 11 is a view showing a combination supply unit, a light emitting unit supply unit, and a light source measurement unit disclosed in this specification.

1 through 9 of the accompanying drawings, a compound separation apparatus according to the present invention includes a mounting unit 100, The coagulating portion 200 and the non-compound separating portion 300 to separate the specific components present in the sample.

The compound separation apparatus optionally includes a control unit 250 to efficiently separate the specific components present in the sample.

The non-compound separating unit 300 may include a separating suction unit 310 and a separating moving unit 320 to remove the non-compound 4.

The non-compound separating unit 300 can selectively separate the complex compound 4 by selectively including the cleaning liquid supply unit 330, the cleaning liquid transfer unit 340, and the cleaning liquid guide 350.

10 to 15, a chemiluminescence immunoassay apparatus according to an embodiment of the present invention includes a compound separating apparatus as disclosed in the present specification, and includes a mount moving part 400, a combine supply part 500, a light emitting part 600, The amount of the specific component contained in the blood or the serum sample can be measured through the light emission of the specific component included in the blood or serum sample.

The moving part 400 includes the driving unit 410 so that the sample is automatically moved.

The assembly supply part 500 includes a combination body 510 and a combination pump 520, a combination injection nozzle 530 and an assembly part 540. The assembly part 500 includes a connection part 2 for reacting with a specific component of the sample And feed it to the sample.

The light source measuring unit 700 includes a first light measuring sensor 710, a second light measuring sensor 720 and a light measuring sensor moving unit 730 to analyze heterogeneous components.

Hereinafter, the compound separation apparatus will be described in more detail with reference to the accompanying drawings.

The stationary part 100 is so constructed that the sample container 10 containing the antigen 1 and the compound 3 of the binding substance 2 and the compound 3 containing the antibody and the magnetism which react with the antigen 1 is mounted .

More specifically, the sample stored in the sample container 10 is the blood or serum of the human body, and the binding substance 2 that reacts with specific components (biomarkers such as CA 19-9, Glypican-1, etc.) . That is, in the sample container 10, the compound (3) and the non-compound (4) in which the specific component and the complex (2) have reacted are present. The conjugate (2) comprises an antibody and a magnetic substance which react with a specific component contained in blood or serum. Furthermore, the binder (2) may include a phosphor.

The mounting portion 100 according to the embodiment disclosed in Figs. 1 to 9 may include a mounting plate 110 disposed at a position away from the ground. And a sample container hole 120 passing through the stationary plate body 110. In this mounting part 100, the sample container 10 is inserted and fixed so that the sample container 10 is exposed to the lower part of the mounting plate 110.

In the meantime, the sample container hole 120 in the embodiment may be formed as a groove so that the sample container 10 is inserted into the groove and exposed to the upper portion of the mounting plate 110. That is, the mounting portion 100 may be configured to secure the sample container 10 securely.

The mounting portion 100 according to another embodiment disclosed in Figs. 11 to 15 may include a mounting plate 110 disposed at a position away from the ground. And a sample container hole 120 passing through the stationary plate body 110. One or more sample container holes 120 may be arranged, and the sample container holes 120 may be arranged in a circle in the mounting plate 110. The stationary part 100 is inserted and fixed by the sample container 10 so that the sample container 10 is exposed to the lower part of the stationary plate 110 and rotated through the stationary part 400 to be described below. The mounting portion 100 has an effect of providing an optimal space necessary for the movement of the sample container 10. [

Meanwhile, in another embodiment, the sample container hole 120 may be formed as a groove so that the sample container 10 is inserted into the groove and exposed to the upper portion of the mount plate 110.

The agglomerating part 200 is arranged on the side surface of the sample container 10 and is configured to agglomerate the compound 3.

According to Figs. 1 to 4 showing one embodiment, the cohesion portion 200 includes a conventional permanent magnet 210. Fig. The coagulation unit 200 is disposed on the side surface of the sample vessel 10 so as to apply magnetism to the interior of the sample vessel 10. The coagulation part 200 coagulates on the inner surface of the sample container 10 in the direction in which the permanent magnets 210 are arranged in the compound 3 that has reacted with the coupling member 2 due to the magnetism of the permanent magnet 210. That is, specific components of blood or serum reacted with the binding substance 2 are aggregated, and the remaining components contained in the blood or serum are present in the sample container 10 in an unaggregated state. The coagulated part 200 has an effect that the non-reacted matter 4 can be easily removed by primarily separating the blood or the specific components contained in the serum through the coupling part 2. The coagulation unit 200 may be disposed below the sample vessel 10 and the structure for coagulating the compound 3 to a specific position within the sample vessel 10 may suffice.

1, the cohesive portion 200 includes a permanent magnet 210 and is connected to the permanent magnet 210 so that the permanent magnet 210 is brought close to the side surface of the sample container 10 (Not shown). More specifically, the magnetic force transfer portion 220 can be constituted by a normal piston. The magnetic force transfer portion 220 is connected to the permanent magnet 210 to move forward to the side surface of the sample container 10 and move backward so that the permanent magnet 210 moves away from the sample container 10. When the permanent magnet 210 is moved away from the sample container 10 by the magnetic force transfer part 220, the cohesion part 200 is lowered in cohesive force of the compound 3 and mixed with the complex compound 4, So that the cohesive force of the coupling body 2 is increased when the sample vessel 10 is brought close to the sample vessel 10. The flocculating portion 200 may adjust the distance from the sample container 10 to control the flocculation of the combined body 2. The aggregation portion 200 controls the cohesive force to finely move the compound 3 so that the compound 3 existing in the residual compound compound 4 or the aggregated compound 3 is released There is an effect that the specific ingredient can be separated more accurately by kneading.

The magnetic force transfer part 220 may be constituted by a conventional servo motor or the like, and may be configured to move the permanent magnet 210 to the sample container 10.

3, the cohesion unit 200 includes a conventional electromagnet 230 that coheres the coupling body 2 in the sample vessel 10, and an electromagnet 230 that supplies power to the electromagnet 230 And a magnetic force transfer unit 220 for moving the electric power supply unit 240 and the electromagnet 230 to be close to the sample vessel 10. When the magnetic force is generated from the electromagnet 230, the cohesive force of the cohesive body 200 is increased and the cohesive force of the cohesive body 2 is lowered when the magnetic force is removed from the electromagnet 230. The flocculating unit 200 can finely adjust flocculation of the flocculating unit 2 according to the amount of electric power provided by the electric power supplying unit 240. The aggregated portion 200 controls the cohesive force to finely move the compound 3 so that the non-compound 4 remaining in the compound 3 or the non-compound 4 existing between the aggregated compounds 3 It is possible to separate specific components more accurately.

Then, the magnetic force transfer portion 220 can prevent the interference of the sample container 10, which may occur when the circular mount portion 100 is carried out, as shown in Fig. The electromagnet 230 is moved away from the sample vessel 10 through the control unit 250 so that the sample vessel 10 is stopped from moving when the sample vessel 10 stops moving. 230 are brought close to the sample vessel 10.

4 to 5 showing another embodiment of the present invention, in the structure of the flocculating unit 200 according to the above-described embodiments, the other side of the sample vessel 10 on which the flocculating unit 200 is not disposed And may include another flocculated portion 200 disposed therein. And a control unit 250 connected to each of the flocculation units 200 to control the respective flocculation units 200 to operate individually. More specifically, the cohesive portion 200 includes the permanent magnet 210 or the electromagnet 230, and may be disposed on the left and right sides of the sample container 10. And may include a magnetic force transfer part 220 connected to each of the permanent magnets 210 or the electromagnet 230 to move the permanent magnet 210 or the electromagnet 230 close to the side surface of the sample container 10 . The magnetic force transfer portion 220 can be constituted by a normal piston. The magnetic force transfer unit 220 is connected to the permanent magnet 210 or the electromagnet 230 to move forward to the side surface of the sample vessel 10 and the permanent magnet 210 or the electromagnet 230 moves away from the sample vessel 10 Backward. When the permanent magnet 210 or the electromagnet 230 is moved away from the sample vessel 10 by the magnetic force transfer part 220, the cohesion part 200 of the cohesion part 200 is lowered in the cohesive force of the compound 3 to be mixed with the complex compound 4, When the magnet 210 or the electromagnet 230 is brought close to the sample vessel 10, the cohesive force of the coupling body 2 is increased. The flocculating portion 200 may adjust the distance from the sample container 10 to control the flocculation of the combined body 2. The aggregation portion 200 controls the cohesive force to finely move the compound 3 so that the compound 3 existing in the residual compound compound 4 or the aggregated compound 3 is released There is an effect that the specific ingredient can be separated more accurately by kneading. Further, since the aggregated portion 200 in the present embodiment is disposed on the left and right sides of the sample container 10, the compound 3 can be moved to the left and right in the sample container 10. The migration of the compound (3) from the compound (3) to the compound (4) can separate the compound (3) from the aggregate and constitute a more pure compound (3) aggregate.

On the other hand, the control unit 250 will be described in more detail below.

The non-compound separating section 300 is configured to separate the non-compound 4 contained in the sample container 10.

1 or 5, is located at a position out of the coagulated position of the coupling body 2 inside the sample vessel 10, so that the separated inhalation 310 < / RTI > And a separation moving part 320 connected to the separation suction part 310 to move the separation suction part 310 to the inside and the outside of the sample container 10 so as to suck the complex compound 4 inside the sample container 10 .

More specifically, the separation suction portion 310 is tubularly connected to the non-compound vessel 311 and the non-compound vessel 311 for storing the separated non-compound 4, (Not shown). And a separation nozzle 313 connected to the separation pump 312 by a tube. The separation nozzle 313 may be disposed in the separating moving part 320 to be described below and the separation nozzle 313 may be disposed in the sample vessel 10 out of the position where the compound 3 is agglomerated by the aggregation part 200 As shown in FIG. The separating moving part 320 is constituted by a normal piston and can be disposed on one side of the mounting part 100. [ The distal end of the piston is connected to the separation nozzle 313 to move the separation nozzle 313 to the inside of the sample vessel 10 and move it to the outside of the sample vessel 10 again. The separating moving part 320 in this embodiment can operate such that the end of the separation nozzle 313 is close to the bottom surface of the sample container 10. [ The separation nozzle 310 is inserted into the sample vessel 10 by the separation unit 320 and then the non-aggregated compound 4 is sucked by the separation pump 312, The inhaled complex (4) is transferred to the non-compound vessel (311). That is, the non-compound (4) contained in the sample container (10) can be separated through the non-compound separating section (300).

Meanwhile, the separation pump 312 and the non-compound vessel 311 may be disposed in the separation unit 320, or the complex compound 4 may be sucked only by the tube from which the separation nozzle 313 is removed. Further, the separating / moving unit 320 may be constituted by a conventional servomotor, and may be configured to move the separating nozzle 313 into the sample container 10.

According to another embodiment disclosed in FIGS. 6 to 7, the non-compound separation unit 300 may further include a washing liquid supply unit 330 for supplying the washing liquid 20 into the sample vessel 10. The non-compound separating section 300 in this embodiment can lower the density of the mixed sample present in the sample container 10 and suck the non-compound 4 with a suction force within such a range that the combined body 2 is not disturbed.

The cleaning liquid supply unit 330 is connected to the cleaning vessel 331 and the cleaning vessel 331 through a tube and supplies the cleaning solution 20 to the interior of the sample vessel 10 And a cleaning pump 332. And a cleaning nozzle 333 connected to the cleaning pump 332 by a tube. The cleaning nozzle 333 may be disposed on the cleaning liquid transfer portion 340, which will be described later, and may be disposed on one side of the separation nozzle 313 described above. The cleaning nozzle 333 is disposed so as to face the inside of the sample container 10 at a position where the cleaning nozzle 333 is not interfered with the separation nozzle 313. The washing solution 20 may be conventional PBST (Phosphate Buffered Saline Tween-20). The cleaning liquid supply unit 330 operates the cleaning pump 332 to move the cleaning liquid 20 stored in the cleaning container 331 to the cleaning nozzle 333 to supply the cleaning liquid 20 into the sample container 10 . The cleaning liquid 20 thus supplied lowers the overall density of the sample present in the sample vessel 10. The lowered density of the sample can be easily sucked through the separation suction unit 310 described above and the noise of the compound 30 can be reduced at the later time. Furthermore, due to the lowered density of the sample, the suction force of the separation suction portion 310 described above can be lowered, which has a correlation with the cohesion force of the aggregation portion 200 described above.

Further, as shown in FIG. 6, the cleaning liquid supply part 330 may include a cleaning liquid transfer part 340. The cleaning liquid transfer portion 340 is composed of a conventional piston and can be disposed on one side of the mounting portion 100. [ The washing liquid transfer portion 340 is connected to the cleaning nozzle 333 at the end of the piston to move the cleaning nozzle 333 into the sample container 10 and then to move the sample outside the sample container 10 again. The cleaning liquid transfer portion 340 in this embodiment can operate so that the end of the cleaning nozzle 333 is close to the compound 3 that is agglomerated on the inner surface of the sample container 10. [ This washing liquid transfer portion 340 can cause the cleaning liquid pump 332 to release the agglomeration of the compound 3 after the cleaning nozzle 333 is inserted into the sample container 10. Further, the aggregate (4) remaining in the aggregate of the compound (3) can be separated by repeating the aggregation and release of the compound (3) together with the aggregate (200) described above.

The washing pump 332 and the washing vessel 331 may be disposed in the washing liquid transfer portion 340 and the washing liquid 20 may be supplied only by the tube from which the washing nozzle 333 is removed. The washing liquid transfer portion 340 may be constituted by a conventional servomotor or may be configured to move the cleaning nozzle 333 into the sample container 10. Further, the cleaning nozzle 333 may be disposed in the separation / movement unit 320 described above.

As shown in FIG. 7, the tip of the cleaning nozzle 333 is disposed to face the inner surface of the sample container 10, so that the direction of the compound 3 is coagulated. This cleaning nozzle 333 not only can easily release the aggregate of the compound 3 but also allows the sample to be supplied with the sample whose volume has been reduced by separation of the complex compound 40 by the separation suction unit 310 described above The sample container 10 can be washed away. This can easily release the agglomeration of the compound (3), and the amount of the washing solution (20) can be gradually reduced as much as the volume of the sample decreases. At this time, all the compounds (3) .

8, the cleaning liquid guide 350 connected to the cleaning liquid supply unit 330 and having an inclined upper surface in the direction in which the condensation unit 200 is disposed . The cleaning liquid guide 350 allows the cleaning liquid 20 to flow to the agglomerated compound 3 irrespective of the direction and position in which the cleaning liquid 20 is injected.

More specifically, the cleaning liquid guide 350 may include a guide portion 351 inclined in one direction and a coupling portion 352 coupled to the cleaning nozzle 333. The guide portion 351 may be inclined upward toward the coupling portion 352. The cleaning liquid guide 350 may be formed to be inserted into the sample container 10. The cleaning liquid guide 350 is disposed in the cleaning nozzle 333 through the coupling part 352 so that the end of the cleaning nozzle 333 is located at the upper end of the guide part 351. When the cleaning liquid 20 is sprayed through the cleaning nozzle 333, it flows down to the other end along the guide portion 351.

Further, the cleaning liquid guide 350 may be formed of a nozzle (not shown) bent in an '?' Shape.

The control unit 250 is configured to selectively control the above-described magnetic force transfer unit 220, the power supply unit 240, the separation pump 312, the cleaning pump 332, and the cleaning liquid transfer unit 340.

The control unit 250 may control the magnetic force transfer units 220 disposed on the left and right sides of the sample container 10 to sequentially operate. Further, it is possible to control the operations of the stationary moving part 400, the combining part supplying part 500, the light emitting part supplying part 600 and the light source measuring part 700.

The compound separation apparatus can reduce the time required for separation as the compound (3) and the non-compound (4) are separated in the sample container (10).

Hereinafter, a chemiluminescent immunoassay using a compound separator will be described in more detail with reference to the accompanying drawings.

The stationary moving part 400 is configured to move the stationary part 100. The fixing unit 400 automatically moves the sample container 10 to the compound supplying unit 500 and the compound separating unit, the light emitting unit supplying unit 600, and the light source measuring unit 700 described above.

According to one embodiment disclosed in FIG. 9, the stapler 400 may be constructed from a conventional conveyor belt. And the mounting part 100 is disposed above the conveyor belt. In the case of implementing such a movable part 400, it is possible to perform the above-described compound separating device, the light emitting unit supplying part 600 and the light source measuring part 700 arranged side by side from the left end side, have.

According to another embodiment disclosed in FIG. 10, the mounting unit 400 may be configured to rotate the mounting unit 100. The stationary moving part 400 may include a driving device 410 configured by a conventional motor. The stationary moving part 400 is disposed below the stationary part 100 to rotate the stationary part 100. In the case of performing such a movable part 400, a coupling body supplying part 500 to be described later is disposed on one side of the mounting part 100, and a light source measuring part 700 and a light emitting part (600) and the compound separation apparatus described above can be arranged.

10, the mounting part 100 according to one embodiment includes a mounting plate 110 connected to the mounting unit 400, and a circular arrangement array 101 in which the sample container 10 is inserted into the mounting plate 110 One or more sample vessel openings 120 may be provided. The flocculating part 200 of the compound separating device is disposed below the mounting part 100 and the non-compound separating part 300 is disposed above the mounting part 100 corresponding to the flocculating part 200.

On the other hand, the driving device 410 of the stationary moving part 400 may include a gear or a belt that rotates in contact with the side surface of the stationary part 100 and may include other driving devices for driving the gear or the belt, The mounting portion 400 may be configured to rotate or move the mounting portion 100.

The combination supplying part 500 is configured to supply the binding body 2 to the sample container 10 in which blood or serum is stored.

10 to 11 may include a combination container 510 in which the combination 2 is accommodated. And a combined body pump 520 connected to the combined body vessel 510 to suck and discharge the combined body 2. And an assembled body injection nozzle 530 connected to the assembly pump 520 to guide the assembled body 2 into the sample container 10. The coupling unit supplying unit 500 supplies the coupling unit 2 reacting with the specific antigen 1 to the sample container 10 in which only the blood or serum is stored so that the sample stored in the sample container 10 contains the specific antigen 1 ) And the compound (3) reacted with the complex (2) and the non-compound (4). The combined injection nozzle 530 is arranged to move to the upper part and the lower part in connection with the light emitting nozzle moving part 640. This makes it possible to shorten the entire process time and prevent the combined injection nozzle 530 from being caught by the movement of the sample container 10 due to the rotation of the mount 100.

Meanwhile, the coupling unit injection nozzle moving unit 540, which is connected to the coupling unit injection nozzle 530 and moves the coupling unit injection nozzle 530 to the inside and the outside of the sample container 10, can be separately configured.

In the conjugate (2) of the present embodiment, a conjugate (2) containing a heterologous antibody, a magnetic substance and a fluorescent substance each reacting with CA-19-9 and Glypican-1 contained in blood or serum is performed, Therefore, two joint supplying parts 500 are also provided, and two joint injecting nozzles 530 are arranged in a position where they do not interfere with each other in one sample container 10.

The luminous body supplying part 600 is arranged on the moving path of the mounting part 100 and configured to supply the chemiluminescent material 6 to the sample container 10 provided by the compound separating device.

The illuminant supplier 600 according to the embodiment disclosed in Figs. 10 to 11 includes the illuminant container 610, the illuminant pump 620, the illuminant nozzle 630, and the illuminant 630, in the same manner as the combination supply unit 500 described above. The nozzle may be comprised of an eccentric portion 640. The light emitting unit supply unit 600 may be disposed on the right side of the light emitting unit supplying unit 600. The luminous body supply part 600 is for mixing the chemiluminescent material 6 with the sample container 10 in which the blood or serum is stored and the sample container 10 through the compound supplying part 500 and the compound separating device described above.

On the other hand, the chemiluminescent material 6 employed in the above embodiment adopts ODI (Oxalyldiimidazole) and hydrogen peroxide (H2O2) for easy explanation of the present invention. Accordingly, the light emitting unit supply unit 600 may also be composed of two light emitting units.

The light source measuring unit 700 is arranged on the moving path of the mounting unit 100 and is configured to measure light emitted from the sample container 10 to which the chemiluminescent material 6 is supplied.

The light source measuring unit 700 according to an embodiment disclosed in FIGS. 10 to 11 may be constituted by a first light measuring sensor 710 which can photograph and analyze an image. Photomultiplier tube (PMT) sensors and SIPMs are typical examples of optical measurement sensors, and light source measurement cameras can be used instead of sensors. The light source measuring unit 700 may be disposed below the mounting unit 100 facing the illuminant supplying unit 600. Since the light source measuring unit 700 is disposed under the mounting unit 100, the installation area can be minimized. The binding body 2 to be performed in this embodiment is comprised of a heterogeneous antibody reacting with CA-19-9 and Glypican-1 contained in blood or serum, magnetic and fluorescent materials, Lt; / RTI > can be expressed. The light source measuring unit 700 may further include a second light measuring sensor 720 to measure light sources of different wavelength ranges. The first light measurement sensor 710 and the second light measurement sensor 720 can allow the sample container 10 moved by the movement unit 400 to pass between the light source measurement units 700.

The light source measuring unit 700 may include a light measuring sensor moving unit 730 for moving the second light measuring sensor 720. The light measuring sensor moving part 730 may be constituted by a normal piston. The light measuring sensor moving unit 730 moves the second light measuring sensor 720 disposed on the rear surface of the sample container 10 to move away from or closer to the sample container 10. [ The light measuring sensor moving part 730 prevents the circular sample container 10 from interfering with the second light measuring sensor 720.

A brief description of the operation of the chemiluminescence immunoassay apparatus according to another embodiment disclosed in FIG. 11 will be given. A sample containing blood or serum of a human body is stored in the sample container 10. Wherein said antigen (1) is CA-19-9 and Glypican-1, said sample comprising a fluorophore conjugated with an antibody reactive with CA-19-9 and another fluorescent substance conjugated with an antibody reactive with Glypican-1 Wherein the binding substance (2) comprises a magnetic substance bound to an antibody reactive with CA-19-9 and an antibody reactive with Glypican-1, wherein the two types of fluorescent substances The chemiluminescent material 6 and the two kinds of phosphors react with each other to generate light of different wavelengths (hereinafter referred to as a first wavelength and a second wavelength).

The sample container 10 containing such a sample is inserted into the sample container hole 120 of the mounting portion 100. In the at least one sample container hole 120, a sample container 10 containing different samples of a person is placed. The coupling body 2 is supplied to the sample vessel 10 located below the coupling body feeding part 500. Thereafter, the stationary moving part 400 rotates, and the new sample container 10 is positioned at the lower end of the combined-body supplying part 500.

The sample to which the conjugate (2) is supplied for the first time reacts with the antigen (1) to generate the compound (3) while being moved to the compound separator by the movable shifter (400). As a result, the sample container 10 is storing the sample composed of the compound (3) and the compound (4) composed of other components. When the sample vessel 10 is moved to the compound separation apparatus, the flocculation unit 200 operates to coagulate the compound 3 on the side wall of the sample vessel 10. Thereafter, the non-compound separation section 300 is operated to separate and separate the non-compound 4. As shown in Fig. 6, a sample in which only the compound (3) exists can be obtained in the sample container (10). Of course, even if the compound (4) is inhaled, the compound (3) may remain in the compound (3).

Here, when the flocculating part 200 is moved close to and away from the sample container 10, the compound 3 is flocculated and separated. At this time, as shown in Fig. 2, the compound (4) attached to the surface of the compound (3) may be dropped. In addition, when the aggregated portion 200 is composed of two and sequentially operated, the agglomerated compound 3 may be moved as shown in FIG. 5 to release the compound 4 that may be present between the compounds 3. Further, when the washing liquid 20 is supplied to the sample container 10, the above-described action can be more easily performed.

The sample container 10 advanced as described above is moved to the lower portion of the luminous body supply part 600 by the stationary moving part 400. At this time, the luminous body supply part 600 operates to supply the chemiluminescent material 6 to the sample container 10. At this time, the light source measuring unit 700 operates to measure and analyze the light source in which the chemiluminescent material 6 contacts the compound 3 and emits light.

From the foregoing it will be appreciated that various embodiments of the present disclosure have been described for purposes of illustration and that there are many possible variations without departing from the scope and spirit of this disclosure. And that the various embodiments disclosed are not to be construed as limiting the scope of the disclosed subject matter, but true ideas and scope will be set forth in the following claims.

1: antigen
2: Coupling
3: Compound
4: Complex
6: chemiluminescent substance
10: Sample container
20: Washing solution
100:
110: mount plate body
120: Sample container hole
200: coagulated part
210: permanent magnet
220:
230: Electromagnet
240: Power supply
250:
300:
310: separation suction part
311: non-compound vessel
312: Separation pump
313: Separation nozzle
320:
330:
331: Cleaning vessel
332: Cleaning pump
333: Cleaning nozzle
340:
350: Cleaning solution guide
400:
410: Driving device
500:
510:
520: Combined Pump
530: Combined spray nozzle
540: Combined nozzle injection nozzle
600:
610:
620: illuminant pump
630: illuminator nozzle
640:
700: Light source measuring unit
710: first light measuring sensor
720: second light measuring sensor
730: Optical measurement sensor

Claims (13)

In the compound separation apparatus,
A mount for mounting a sample container in which a compound having magnetism and a compound having no magnetism are accommodated;
A flocculent disposed on a side surface of the sample vessel for flocculating the compound; And
And a non-compound separation section for separating the non-compound contained in the sample container,
The compound and the non-complex are generated through reaction between a sample containing an antigen and a complex that reacts with the antigen,
Said conjugate comprising an antibody reactive with said antigen and a magnetic entity associated with said antibody,
Wherein the coagulation portion includes a permanent magnet for cohesion of the coupling body received in the sample vessel and a magnetic force transfer portion for moving the permanent magnet close to the sample vessel,
Another flocculent disposed on the other side of the sample vessel in which the flocculating portion is not disposed; And
And a control unit for causing each of the coagulating units to sequentially operate,
By moving the compound leftward and rightward within the sample vessel, the compounds present between the compounds in a short period of time can be separated from the aggregates of the compounds to constitute a more pure compound (3) aggregate. delete delete The method according to claim 1,
The non-
A separation suction unit positioned at a position outside the coagulated position of the coupling body in the sample vessel to suck the complex; And
And a separation / movement unit connected to the separation / suction unit to move the separation / suction unit into and out of the sample container. 5. The method of claim 4,
Wherein the non-compound separation unit includes a cleaning liquid supply unit for supplying the cleaning liquid into the sample container. 6. The method of claim 5,
Wherein the non-organic compound separating portion includes a washing liquid transferring portion for transferring the washing liquid supplying portion into the sample container, and allowing the washing liquid to be injected to a position where the coupling body is coagulated. 6. The method of claim 5,
Wherein the non-compound separation unit includes a cleaning liquid guide connected to the cleaning liquid supply unit and having an upper surface inclined in the direction of the inner surface of the sample container opposite to the coagulation unit. 8. A compound separation apparatus according to any one of claims 1 to 7,
A mounting part for moving the mounting part;
A light emitter supplying unit disposed on a moving path of the mounting unit to supply the chemiluminescent material to the sample container provided by the compound separating apparatus; And
And a light source measuring unit arranged on a moving path of the stationary part and measuring light emitted from the sample container to which the chemiluminescent material is supplied,
Wherein the compound separating apparatus is disposed on a moving path of the mounting portion, and includes a combining body supplying portion for supplying the combining body,
Wherein the sample container accommodated in the mounting portion is accommodated in the sample container and the sample container in which the sample is accommodated is provided to the combination container supply portion through the accommodation moving portion,
And the coupling agent supply unit supplies the coupling agent to the sample vessel provided by the immobilizing unit, thereby preparing the sample vessel in which the compound and the non-compound are accommodated. 9. The method of claim 8,
Wherein the mounting portion includes a mounting plate member connected to the mounting portion and at least one sample container hole arranged in a circular shape in which the sample container is inserted into the mounting plate member,
Wherein the stationary moving part includes a driving device connected to the stationary part to rotate the stationary part. 9. The method of claim 8,
The combination supply unit
A combination container in which the combination is accommodated;
A combined pump connected to the combined vessel and sucking and discharging the combined vessel;
A combined body spray nozzle connected to the combined body pump to guide the combined body into the sample container; And
And a coupling member injection nozzle connected to the coupling member injection nozzle to move the coupling member injection nozzle into and out of the sample container. 9. The method of claim 8,
Wherein the flocculating portion is disposed below the mounting portion, and the non-compound separation portion is disposed above the mounting portion corresponding to the flocculating portion. 9. The method of claim 8,
Wherein the light emitter supplying part is disposed on the upper portion of the mounting part, and the light source measuring part is disposed below the mounting part facing the light emitter supplying part. 9. The method of claim 8,
The antigen is CA-19-9 and Glypican-1,
Said sample comprising a fluorescent conjugate comprising a fluorophore conjugated to an antibody responsive to CA-19-9 and another fluorophore conjugated to an antibody responsive to Glypican-1,
Said conjugate comprising a magnetic body bound to an antibody reactive with CA-19-9 and an antibody reactive with Glypican-1,
The two kinds of phosphors of the fluorescent combination have different wavelengths of light,
The chemiluminescent material and the two types of phosphors react with each other to generate light of different wavelengths (hereinafter referred to as a first wavelength and a second wavelength)
The light source measuring unit
A first optical measurement sensor and a second optical measurement sensor disposed opposite to each other with the sample container interposed therebetween and capable of photographing the light of the first wavelength and the light of the second wavelength, respectively; And
And a light measuring sensor moving unit for moving the first light measuring sensor or the second light measuring sensor toward or away from the sample container.

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