KR20220099446A - Reusable elisa kit - Google Patents

Abstract

The present invention relates to an ELISA diagnostic kit. According to one aspect of the present invention, provided is the ELISA diagnostic kit which comprises: a main body unit having an active surface for sample analysis, a sample unit electrically connected to the active surface, and a receiving space; an insertion space having the main body unit inserted therein and having a through hole for passing a sample toward the active surface when the main body unit is inserted into a ready position; and a cover unit partitioned from the insertion space and having a storage space in which liquid is stored. According to the ELISA diagnostic kit of the present invention, when the main body unit is inserted into the cover unit and the main body unit is entered so that the active surface passes through the insertion space and is positioned at a measurement position of the storage space, the liquid of the cover unit is accommodated in the receiving space of the main body unit after flowing over the active surface.

Description

Reusable ELISA diagnostic kit {REUSABLE ELISA KIT }

The present invention relates to a diagnostic kit using the ELISA method, and to an ELISA diagnostic kit capable of diagnosing not only blood (whole blood, plasma, serum) but also all body fluids such as runny nose and urine as a sample.

The development of diagnostic methods and diagnostic tools by quantitatively measuring trace substances contained in biological samples such as blood is rapidly advancing.

In the case of protein detection, an immunological method using a reaction between an antigen and an antibody is mainly used. For example, there are enzyme linked immunosorbent assay (ELISA) and immunochromatographic methods. However, there are problems in that it takes a lot of time for sample processing and analysis, is greatly affected by external conditions such as temperature and time, and requires a well-trained expert to obtain accurate results. In particular, the development of a method with high sensitivity and specificity is required for rapid, reproducible, and high-sensitivity in situations requiring rapid judgment and presence of serious diseases.

Korean Patent Publication No. 10-2014-0133506 (2014.11.19)

The present invention aims to solve the problem of providing an ELISA diagnostic kit that can be used for various analyses by connecting the ELISA diagnostic kit that is easy to clean the active surface only by insertion operation and has completed cleaning the active surface to an external device. do.

Another object of the present invention is to provide a reusable ELISA diagnostic kit housing by separating the plate on which the sample is loaded.

In order to solve the above problems, according to an aspect of the present invention, there is provided an active surface for sample analysis, a body portion having a sample portion electrically connected to the active surface and a receiving space; and an insertion space having a through hole for passing a sample to the active surface side when the body part is inserted, and a cover part partitioned from the insertion space, and having a storage space in which the liquid is stored when the body part is inserted into the ready position. is provided

In addition, when the body part is inserted into the cover part, and the active surface passes through the insertion space and enters the body part to be positioned at the measuring position of the storage space, the liquid of the cover part flows through the active surface and is received in the receiving space of the body part .

As described above, the ELISA diagnostic kit according to at least one embodiment of the present invention has the following effects.

Not only blood (whole blood, plasma, serum), but also all body fluids such as runny nose and urine can be diagnosed as a sample.

In addition, it is easy to clean the active surface only by inserting the main body part, and by connecting the ELISA diagnostic kit that has been cleaned of the active surface to an external device, it can be utilized for various analyses.

In addition, there is a feature that the housing can be reused by replacing only the plate on which the sample is loaded after use.

1 is a plan view of a diagnostic kit according to an embodiment of the present invention.
2 is a side view of a diagnostic kit according to an embodiment of the present invention.
3 is a photograph showing the movement of the main body of the diagnostic kit according to an embodiment of the present invention.
4 is a flowchart illustrating a procedure for using a diagnostic kit according to an embodiment of the present invention.

Hereinafter, an ELISA diagnostic kit according to an embodiment of the present invention will be described in detail with reference to the accompanying drawings.

In addition, regardless of the reference numerals, the same or corresponding components are given the same or similar reference numbers, and overlapping descriptions thereof will be omitted, and the size and shape of each component shown for convenience of explanation is exaggerated or reduced. can be

1 is a plan view of a diagnostic kit according to an embodiment of the present invention, and FIG. 2 is a side view of the diagnostic kit according to an embodiment of the present invention.

1 to 2 , the ELISA diagnostic kit 10 according to the first embodiment includes a body part 100 and a cover part 200 provided to insert the body part 100 therein.

The body part 100 has an active surface 101 for sample analysis, a sample part 103 electrically connected to the active surface 101, and a receiving space 131 . As described above, the sample may be a bodily fluid including blood.

The active surface 101 is a place on which the sample is seated, and may be formed of, for example, silicon. In addition, the active surface 101 may be attached to a genome such as an antibody or DNA by an adsorption or coating process. For example, after coating the primary antibody on the active surface 101 made of a silicone material, in order to prevent non-specific binding, a blocking treatment may be performed. In addition, when the antibody is attached to the active surface 101, the unbound antibody may be washed away after a certain period of time. Depending on the analytical principle, other reactants may also adhere to the active surface. For example, in a sandwich assay, a luminescent complex or other type of single-cell (secondary) antibody labeled using an enzyme may be additionally utilized. The secondary antibody labeled as described above can be attached to the active surface even in the state of being mixed with the sample or sample.

The sample part 103 surrounds the active surface 101 and is electrically connected to the fixing part 102 for exciting the active surface 101 . When power is supplied through the sample unit 103 , hot electrons are emitted from the active surface 101 , and energy is transferred to the light emitting material by the hot electrons to generate light.

In addition, the sample unit 103 may have +/- terminals, and may have two + terminals and two - terminals. The sample unit 103 may be electrically connected to an external device for sample analysis. For example, the external device includes a tray capable of loading the analysis kit 10 , a motor that can be cleaned by pushing the analysis kit 10 , and a 4-pin capable of applying an electrical signal to the analysis kit 10 . It may include a fixing unit, a photomultiplier tube (PMT) capable of measuring a light emitting signal.

In addition, the active surface 101 , the fixing part 102 , and the sample part 103 may be respectively formed on the flexible substrate FPCB.

In addition, the main body 100 may include a main body 110 , a cover 140 slidably mounted on the main body 110 , and a filter 150 provided on the cover 140 .

The body 110 has an active surface 101 , a sample part 103 , and an accommodation space 131 . In addition, the body 110 includes an upper member 120 and a lower member 130 coupled to the upper member 120 . In addition, the upper member 120 may include a flexible substrate on which the active surface 101 , the fixing part 102 , and the sample part 103 are provided. In addition, the upper member 120 is disposed to cover the lower member 130 having the accommodation space 131 .

In addition, the main body 110 has a flow hole 126 connected to the receiving space 131 and the fluid movement. For example, the flow holes 126 may be provided as a pair on both sides with respect to the active surface 101 . On the other hand, when the active surface 101 is located in the storage space 220 of the cover part 200 , the liquid in the storage space 220 flows through the active surface 101 and then passes through the flow hole 126 . It is accommodated in the accommodation space (131).

In addition, the cover 140 is slidably mounted on the body 110 . In addition, the cover 140 has an opening 141 through which the sample passing through the through hole 211 is introduced. In addition, the cover 140 is provided to selectively surround the active surface 101 according to the sliding movement.

In addition, the filter 150 is provided on the cover 140 to be positioned on the active surface 101 according to the movement of the cover 140 . The filter may be formed of a polymer material having filtration performance, such as PE (Polyester) or PC (polycarbonate), and performs a function of filtering out substances unnecessary for measurement among many substances present in the blood. In addition, the filter may serve to immobilize the antibody to which the luminous body is attached. In addition, the filter 150 may be fixed to the mounting portion 142 of the cover 140 or may be detachably mounted.

Meanwhile, the sample passing through the through hole 211 passes through the opening 141 of the cover 140 and the filter 150 to reach the active surface 101 .

The cover part 200 has a through hole 221 for passing the sample to the active surface 101 side when the body part 100 is inserted, and the body part 100 is inserted into the ready position (position in FIG. 2). It has an insertion space 210 and a storage space 220 that is partitioned from the insertion space 210 and stored therein. The liquid may be a washing liquid, for example, a standard electrolyte solution. The liquid can wash off the unbound antibody on the active surface 101 . Specifically, the washing solution functions to remove residual antigens and antibodies that did not participate in the antigen-antibody reaction, and also functions as an electrolyte to help electron movement and redox reaction during measurement. The cover part 200 may be formed of a general resin material through which light can pass, for example, it may be formed of a PP (Polypropylene) or PC (Polycarbonate) material.

In this document, the preparation position is inserted into the insertion space 210 of the main body 100, the through hole 211, the opening 141 of the cover 140, and the filter 150 along the input direction of the sample. ) and the active surface 101 means a position in which they are arranged side by side. Here, the side-by-side arrangement means a position arranged so that the sample can pass through the through hole 211 , the opening 141 of the cover 140 , and the filter 150 sequentially to reach the active surface 101 . means

In addition, as shown in FIG. 3 , the measurement position means a position where the main body 100 further enters the cover 200 and the active surface 101 enters the storage space 220 .

In the preparation position, when the sample is injected through the through hole 211 , the sample passes through the opening 141 and the filter 150 to move toward the active surface 101 .

In the preparation position, the sample is injected into the through-hole 211 , and the main body 100 enters the storage space 220 from the initial position.

At this time, the body part 100 is inserted into the cover part 200 , and the main body part 100 enters so that the active surface 101 passes through the insertion space 210 and is positioned at the measurement position of the storage space 220 . When the liquid in the storage space 220 of the cover part 200 flows through the active surface 101 , it is accommodated in the accommodation space of the body part 100 .

In addition, the cover part 200 is provided in the insertion space 210 , and when the main body part 100 enters the storage space 220 , it comes into contact with the cover 140 and the cover 140 moves into the storage space 220 . It has a stopper 230 for blocking entry.

Referring to FIG. 3 , when the body part 100 enters the storage space 220 , the cover 140 in contact with the stopper 230 slides in the opposite direction to the entry direction of the body 210 , and the cover ( 140) and the filter 150 are positioned in the insertion space 210, and the active surface 101 is exposed into the insertion space.

2 and 3 , the main body 110 has a guide rail 122 for guiding the sliding movement of the cover 140 , and the cover 140 has a guide protrusion 143 inserted into the guide rail 122 . can have In addition, the cover 140 may have an insertion groove 144 having a movement displacement shorter than that of the guide rail 122 , and the body 110 may have an insertion protrusion 124 inserted into the insertion groove 144 .

In addition, the body 110 and the cover 140 may be detachably mounted. Alternatively, by engaging the guide protrusion 143 in the guide rail 122 , the cover 140 may be non-separably mounted to the body 110 .

*37 In addition, the cover part 200 may have a diaphragm for partitioning the insertion space 210 and the storage space 220 , and the body part 100 may have one or more protrusions 121 for breaking the diaphragm. . In addition, the protrusions 121 may be provided as a pair on both sides with respect to the active surface 101, and may be provided so that the liquid flows into the active surface 101 through the gap between the pair of protrusions 121. . The opposite surface of each of the protrusions 121 forming a space between the pair of protrusions 121 may be formed as inclined surfaces. The diaphragm may be formed of an aluminum material or a vinyl-shaped polymer that does not pass a solution and has a predetermined rigidity.

Referring to FIG. 3 , when the protrusion 121 pierces the diaphragm and the active surface 101 is positioned in the storage space 220 , the liquid washes the active surface 101 and is received through the flow hole 126 . It is accommodated in the space 131 .

At this time, the cover 140 slides in the opposite direction to the entry direction of the main body 210 , is positioned in the insertion space 210 , and closes the through hole 211 of the insertion space 210 . placed in a blocking position. Accordingly, the liquid does not flow out of the assay kit 10 through the through hole 211 .

In addition, in the state of the ELISA diagnostic kit 10 as shown in FIG. 3 , the sample unit 103 is electrically connected to an external device so that analysis can be performed.

3 is a photograph illustrating the movement of the main body of the diagnostic kit according to an embodiment of the present invention, and FIG. 4 is a flowchart illustrating the use of the diagnostic kit according to an embodiment of the present invention.

The ELISA diagnostic kit 20 related to the second embodiment includes a body part 300 and a cover part 400 provided to insert the body part 300 therein.

The ELISA diagnostic kit 20 related to the second embodiment, unlike the first embodiment, does not include the cover 140 , and the through-hole 411 of the cover part 400 is provided in the main body of the main body part 300 . It has a difference in that it has a protrusion 325 to prevent it from closing.

Specifically, the main body 300 includes an active surface 301 for sample analysis, a sample portion 303 electrically connected to the active surface 301 , and an accommodation space 331 .

The sample part 303 surrounds the active surface 301 and is electrically connected to a fixing part 302 for exciting the active surface 301 . When power is supplied through the sample unit 303 , hot electrons are emitted from the active surface 301 , energy is transferred to the light emitting material by the hot electrons, and light is generated. In addition, the sample unit 103 may have +/- terminals, and may have two + terminals and two - terminals. The sample unit 103 may be electrically connected to an external device for sample analysis.

In addition, the main body 300 includes an active surface 301, a body having a sample portion 302 and a receiving space 331, and guide rails ( 327) and a filter 350 disposed on the active surface 301 or movably disposed along the guide rail 327 so as to be separated from the active surface. In the second embodiment, without the cover 140 , the filter 350 alone is movably disposed on the guide rail 327 . In addition, the main body of the main body 300 may include a plurality of guide protrusions 328 for supporting the position of the filter 350 in the preparation position.

6 and 10 , when the sample is injected through the through hole 411 in the prepared position described in the first embodiment, the sample passes through the filter 350 and moves toward the active surface 301 .

In addition, the main body of the main body part 300 includes an upper member 320 and a lower member 330 coupled to the upper member 320 . In addition, the upper member 320 has the above-described active surface 101, the fixing portion 102, the sample portion 103, the guide rail 327 and the guide projection 328, and also the above-described projection 325 has In addition, the upper member 320 is disposed to cover the lower member 330 having the accommodation space 331 .

In addition, the main body (specifically, the upper member) of the main body part 300 has a flow hole 326 connected to the receiving space 331 to be fluidly movable. For example, the flow hole 326 may be provided in a space between the active surface 301 and the protrusion 325 . On the other hand, when the active surface 301 is located in the storage space 420 of the cover part 400, the liquid in the storage space 420 flows through the active surface 301 and then passes through the flow hole 326. It is accommodated in the accommodation space 331 .

On the other hand, the filter 350 is engaged at least in part with the through hole 411 at the ready position, and when the body part 300 enters the storage space 420 , in the opposite direction to the entry direction of the body part 300 . It may move along the guide rail 327 . That is, when the main body 300 enters the storage space 420 , the filter 350 is engaged with the through hole 411 , and the guide rail 327 is moved in the opposite direction to the entry direction of the main body 300 . is moved along

The cover part 400 is an insertion space 410 having a through hole 411 for passing the sample to the active surface 301 side when the body part 300 is inserted and the body part 300 is inserted into the ready position. And it is partitioned from the insertion space 410, and has a storage space 420 in which the liquid is stored. As described in the first embodiment, the liquid may be a washing solution, and may wash the non-bound antibody on the active surface 101 .

Also in the second embodiment, the ready position means a position arranged as in FIGS. 3 and 4, and the measurement position is, as shown in FIG. 400) and means a position where the active surface 301 is entered in the storage space 420 .

3 and 4, when the main body 300 enters the storage space 420, the filter 350 is positioned in the insertion space 410 in a state engaged with the through hole 411, the active surface ( 301 is exposed into storage space 420 .

In addition, the cover part 400 has a diaphragm 440 for partitioning the insertion space 410 and the storage space 420 , and the body part 300 has one or more protrusions 321 for breaking the diaphragm 440 . has

As in the first embodiment, the main body of the main body has a flow hole 326 movably connected to the receiving space 313 , and when the active surface 301 is located in the storage space 420 , the liquid is activated After the surface 301 flows, it passes through the flow hole 326 and is accommodated in the accommodation space 331 .

3 and 4 , when the protrusion 321 of the main body 300 penetrates the diaphragm 440 and the active surface 301 is located in the storage space 420 , the liquid is transferred to the active surface 301 . and is accommodated in the accommodation space 331 through the flow hole 326 .

In addition, the body of the main body 300 may include a protrusion 325 for preventing the through hole 411 from being closed when the active surface 301 is located in the storage space 440 . 12 and 13 , when the protrusion 325 blocks the through-hole 411 , the filter 350 comes into contact with the protrusion 325 , and the sliding movement is restricted. Since the protrusion 325 blocks the through hole 411 , the liquid does not flow out of the assay kit 20 through the through hole 411 .

In addition, in the state of the ELISA diagnostic kit 20 as shown in FIG. 13 , the sample unit 303 is electrically connected to an external device so that analysis can be performed.

The preferred embodiments of the present invention described above are disclosed for the purpose of illustration, and various modifications, changes, and additions may be made by those skilled in the art having ordinary knowledge of the present invention within the spirit and scope of the present invention, and such modifications, changes and additions shall be deemed to fall within the scope of the following claims.

10, 20: ELISA diagnostic kit
100, 300: body part
200, 400: cover part

Claims (14)

a body part having an active surface for sample analysis, a sample part electrically connected to the active surface, and a receiving space; and
a body portion is inserted, and an insertion space having a through hole for passing a sample to the active surface side when the body portion is inserted into the ready position and a cover portion partitioned from the insertion space, the cover portion having a storage space in which a liquid is stored;
When the body part is inserted into the cover part, and the active surface passes through the insertion space and enters the body part to be positioned at the measuring position of the storage space, the liquid of the cover part flows through the active surface and is received in the receiving space of the body part,
The body part includes a body having an active surface, a sample part, and a receiving space,
The main body of the main body includes a lower member having an accommodation space and an upper member disposed to cover the lower member, and provided with an active surface, a fixing part, and a sample part,
The main body of the main body has a flow hole connected to the receiving space to be movably fluid,
When the active surface is located in the storage space of the cover part, the liquid flows through the active surface, passes through the flow hole, and is received in the receiving space of the body part,
The liquid is a cleaning solution, the ELISA diagnostic kit. According to claim 1, wherein the body portion,
a cover slidably mounted on the body, having an opening, and provided to selectively surround the active surface according to the slide movement; and
ELISA diagnostic kit comprising a filter provided on the cover to be positioned on the active surface according to the movement of the cover. 3. The method of claim 2,
In the preparation position, when the sample is injected through the through hole, the sample passes through the opening and the filter and moves to the active surface side. 3. The method of claim 2,
The cover part is provided in the insertion space, and when the body part enters the storage space, the ELISA diagnostic kit has a stopper for blocking the cover from entering the storage space by contacting the cover. 5. The method of claim 4,
When the body part enters the storage space, the cover in contact with the stopper slides in the opposite direction to the entry direction of the body, the cover and filter are located in the insertion space, and the active surface is exposed into the insertion space. 5. The method of claim 4,
The body has a guide rail for guiding the sliding movement of the cover,
The cover is an ELISA diagnostic kit having a guide protrusion that is inserted into the guide rail. 5. The method of claim 4,
The cover part has a diaphragm for partitioning the insertion space and the storage space,
The body portion of the ELISA diagnostic kit having one or more protrusions for breaking the diaphragm. According to claim 1, wherein the body portion,
guide rails having active surfaces on both sides, respectively, along the insertion direction of the body; and
An ELISA diagnostic kit comprising a filter positioned on an active surface or movably disposed along a guide rail so as to be separated from the active surface. 9. The method of claim 8,
In the preparation position, when the sample is injected through the through hole, the sample passes through the filter and moves to the active surface side. 9. The method of claim 8,
The filter is engaged with the through hole at least in part at the ready position, and when the main body enters the storage space, the filter moves along the guide rail in the opposite direction to the main body's entry direction. 9. The method of claim 8,
When the body portion enters the storage space, the filter is positioned within the insertion space, and the active surface is exposed into the storage space. 9. The method of claim 8,
The cover part has a diaphragm for partitioning the insertion space and the storage space,
The body portion of the ELISA diagnostic kit having one or more protrusions for breaking the diaphragm. 13. The method of claim 12,
The main body of the main body, the ELISA diagnostic kit including a protrusion for blocking the through-hole to be closed when the active surface is located in the storage space. 14. The method of claim 13,
When the protrusion blocks the through-hole, the filter is in contact with the protrusion ELISA diagnostic kit.

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