KR102483098B1 - Sample insertion type diagnostic kit - Google Patents

Abstract

The present invention relates to a specimen insertion-type diagnostic kit comprising a main body into which a specimen can be injected and a test paper displaying a chemical reaction upon contact with the specimen inside the main body, and displaying the reaction result of the test paper. The present invention provides the specimen insertion-type diagnostic kit, which blocks evaporation of the specimen and prevents the test results from being damaged due to contact with the outside.

Description

Sample insertion type diagnostic kit {SAMPLE INSERTION TYPE DIAGNOSTIC KIT}

The present invention relates to a specimen insertion-type diagnostic kit for diagnosing a specimen, which includes a body part into which a specimen can be injected and a test paper that exhibits a chemical reaction when in contact with the specimen inside the body part, thereby minimizing direct contact with the outside to prevent infection. It relates to a specimen insertion type diagnostic kit capable of preventing a phenomenon from occurring.

In general, a diagnostic kit is a device that can easily and quickly diagnose the presence of various diseases by examining or examining the presence of a single or multiple substances in a liquid sample, for example, saliva, urine, or blood sample.

In a conventional immunochromatographic analysis system, a detection antibody polymerized with a label is accumulated in a dry state on a conjugation pad, and when a sample is added, the conjugate dissolves and reacts with the analyte in a liquid phase. Such a reaction occurs in a state where the sample solution moves according to the fluid flow caused by capillary action, and an immune complex is formed between the conjugate and the analyte through sandwich bonding. These immune complexes migrate to the top of the membrane and are captured by immobilized antibodies that specifically react with the analyte, generating a signal proportional to the concentration of the analyte.

In the form of a conventional immunochromatography diagnostic kit, there is an absorption rod protruding from a plastic case, and a mid-stream type designed to detect and determine diagnostic markers in body fluid by smearing body fluid, etc. There are a caseette type designed to take a small amount with an instrument and drop it into the sample inlet of the kit for examination, and a dip-stick type designed not to use a plastic case.

The sample is dropped and absorbed on the sample pad of the analysis strip located at the bottom of the sample inlet through the sample inlet in the upper case of the diagnostic kit, and the absorbed sample is moved to the adjacent conjugate pad to combine with colored particles, and then nitro spread along a cellulose membrane. The unfolded sample indicates whether or not the test result is indicated on the test line at a specific position on the membrane, and the test result is judged from the outside through the test result window of the upper case. The expanded sample continues to move and is finally absorbed into the absorption pad.

Therefore, since the test result window of the upper case of the membrane of the assay strip is exposed to the outside, evaporation of the sample may occur and the test result may be deformed over time, while the test result may be damaged due to direct contact with the outside of the membrane. There is a big problem that could be. In particular, the advantage of cassette-type diagnostic kits is infection prevention through minimization of direct contact between the assay strip and the outside. In conventional diagnostic kits, there is a possibility that the membrane displaying the result may come into direct contact with the outside through the test result window. There is a big problem.

Republic of Korea Patent Registration No. 10-1805451

In order to solve the above problems, the present invention provides a body unit into which a sample can be injected and a test paper that exhibits a chemical reaction upon contact with the sample inside the body unit to block evaporation of the sample and test results by contact with the outside. It is intended to provide a sample insertion type diagnostic kit that prevents damage to the sample.

In order to achieve the above object, the present invention provides a body portion having an accommodation space therein, and is provided on one side of the inside of the body portion to communicate with the outside so that a sample can be injected, and is mixed with the injected sample to kill pathogens in the sample. A sample extraction unit containing a solution for extraction, a cylinder unit formed to communicate with the outside on the other side of the main body unit with a partition wall provided with a nozzle so that the solution mixed in the sample extraction unit passes therebetween, and communication of the cylinder unit A piston part that is inserted into the cylinder part and slides in the cylinder part to close or open the nozzle provided in the partition wall, and to the bottom of the cylinder part so that the solution transferred into the cylinder part by the sliding movement of the piston part flows into the cylinder part. A discharge hole is formed, and a test strip reacting upon contact with the discharged solution is disposed on the bottom of the discharge hole to include a result unit displaying the reaction of the test strip.

More preferably, the sample extraction unit may be configured by attaching a sealing paper to the frontmost part communicating with the outside so that the solution contained therein is vacuum-packed and kept sealed until it is opened.

More preferably, one side or both sides of the barrier rib is formed to be inclined, and a check valve opened and closed in only one direction may be further included on either side of the nozzle formed in the center of the barrier rib.

More preferably, the piston unit is composed of a grippable pusher member and a packing member coupled to the front end of the pusher member, and blocks the nozzle of the partition wall through the packing member to block leakage of the solution from the sample extraction unit, The solution may be transported to the cylinder part by applying pressure to the sample extraction part by sliding the piston part.

More preferably, the push rod member is composed of a head part coupled to the packing member and a gripping part extending to the other side of the head part and capable of being gripped, and one side of the outer circumference of the head part has a larger diameter than the outer circumference of the gripping part. An engaging protrusion may be formed protruding from one side of the inner diameter of the cylinder portion to engage the engaging sphere.

More preferably, when holding the gripping part of the push rod member and pulling it to the communicating part of the cylinder part, the locking hole of the head part is caught on the locking protrusion of the cylinder part and the movement is restricted, and when a force for pulling the gripping part is added, the A cutting groove may be further included at a boundary between the head portion and the gripping portion of the push rod member so that the head portion and the gripping portion are cut and separated.

More preferably, the body portion may be formed of a transparent material so that the movement of the solution and the reaction of the test strip can be identified from the outside.

More preferably, the discharge hole may further include a guide groove formed with a concave upper side in order to induce discharge of the solution.

More preferably, the resulting portion may have a flat bottom area in contact with the ground.

More preferably, a tray for seating the test paper is provided at the bottom of the result unit, and a support protrusion protruding upward is further formed on the upper surface of the tray to support the lower surface of the test paper so that the test paper is always in close contact with the discharge hole. can include

More preferably, the support protrusion may further include an elastic member to which an elastic force is applied such that the test paper is always in close contact with the discharge hole.

The specimen insertion type diagnostic kit according to the present invention provides the following effects.

That is, by providing a body portion into which a sample can be injected and a test paper exhibiting a chemical reaction upon contact with the sample inside the body portion, the effect of blocking evaporation of the sample and preventing test results from being damaged due to contact with the outside can be obtained.

In addition, by providing a solution inside, it is possible to reduce the test time and increase the efficiency of work by providing a separate solution and reducing the process of contacting the specimen.

In addition, since the effects of the present invention described as described above are naturally exhibited by the configuration of the described contents regardless of the inventor's knowledge, the above-described effects are only a few effects according to the described contents, and all the effects grasped or realized by the inventor It should not be accepted as written.

In addition, the effect of the present invention should be additionally grasped by the overall description of the specification, and even if it is not described in an explicit sentence, those skilled in the art to which the described contents belong will have such an effect through this specification. If the effect can be recognized as such, it should be regarded as the effect described in this specification.

1 is a perspective view of a specimen insertion type diagnostic kit according to an embodiment of the present invention;
2 is an exploded perspective view of a specimen insertion type diagnostic kit according to an embodiment of the present invention;
3 is a side cross-sectional view of a specimen insertion type diagnostic kit according to an embodiment of the present invention;
4 is a diagram illustrating an operating state of a partition wall and a nozzle according to another embodiment of the present invention;
5 is a view illustrating an operating state of a piston unit according to an embodiment of the present invention;
6 is a diagram illustrating an operating state of a partition wall and a nozzle according to another embodiment of the present invention;
7A to 7E are diagrams illustrating a method for diagnosing a specimen using a specimen insertion type diagnostic kit according to an embodiment of the present invention.

Hereinafter, configuration and operation according to a preferred embodiment of the present invention will be described in detail with reference to the accompanying drawings.

This is to explain the contents of the present invention in detail so that those skilled in the art can easily practice the contents of the present invention, and this does not mean that the technical spirit and scope of the present invention are limited. .

In addition, in adding reference numerals to the components of each drawing, it should be noted that the same components are marked with the same numerals as much as possible even if they are displayed on different drawings, considering the configuration and operation of the present invention. Therefore, the terms specifically defined may vary according to the intention or custom of the user or operator, and the definitions of these terms should be determined based on the contents throughout this specification.

In addition, throughout the specification, when a certain component is said to "include", it means that it may further include other components without excluding other components unless otherwise stated.

1 is a perspective view of a specimen insertion type diagnostic kit according to an embodiment of the present invention, Figure 2 is an exploded perspective view of the specimen insertion type diagnostic kit according to an embodiment of the present invention, and FIG. 3 is a perspective view of the specimen insertion type diagnostic kit according to an embodiment of the present invention. It is a side cross-sectional view of the specimen insertion type diagnostic kit.

As shown in FIGS. 1 to 3, the diagnostic kit 1 is largely composed of a sample extraction unit 210, a cylinder unit 220, a partition wall 230, a piston unit 240, and a result unit 250. (200) and a sample collecting unit (100) to which a cotton swab (120) is coupled so as to be inserted into the body unit (200).

The body portion 200,

It is made in the form of a tube having an accommodation space therein, and the shape can be made of a polygon or an ellipse as well as a cylindrical shape as in the embodiment of the present invention without having to be set to any one shape. In addition, the bottom surface of the body portion 200 may be formed flat to facilitate the arrangement of the resultant portion 250 to be described later, and the bottom portion formed flat may stand on its own on the floor.

In addition, the material of the body portion 200 may be made of a chemically safe synthetic resin or a combination thereof. Thermosets and thermoplastics such as, but not limited to, polyethylene, polypropylene, polystyrene, polyethylene terephthalate, polyamide, polyester, polyvinylchloride, polyurethane, polycarbonate, polyvinylidene chloride, polyetherimide It can be manufactured using known molding methods using a variety of plastics and combinations thereof.

In addition, since the material may be made transparent, the movement of the solution (S) and the reaction of the test strip 253, which will be described later, can be easily identified from the outside.

Furthermore, as another embodiment of the present invention, an enlarged display window 200a having a built-in convex lens may be further included in a portion of the main body 200 to enlarge and show the inside.

The sample extraction unit 210,

A solution (S) which is provided on one side of the body unit 200 described above, communicates with the outside so that a specimen can be injected, and mixes with the injected specimen to extract pathogens from the specimen can be accommodated. In this case, the sample extraction unit 210 may attach sealing paper 211 to the frontmost part communicating with the outside so that the solution (S) contained therein is vacuum-packed and kept sealed until it is opened. Therefore, in order to introduce a sample into the sample extraction unit 210, a process of first removing the sealing paper 211 attached to the front end of the sample extraction unit 210 must be performed.

The specimen referred to here refers to materials necessary for examination, and clinically, blood, urine, fluid, secretion fluid, pharyngeal mucus, sweat, etc. may be used. In the present specification, it should be noted that the above-described sample and the cotton swab 120 of the sample collection unit 100 with the sample are defined as the same component, and may be used interchangeably.

In addition, the above-mentioned solution (S) may be made of a material suitable for a test including detection and analysis of a sample through mixing with a sample, that is, a predetermined antibody that reacts with an antigen or the like. In the present specification, it should be noted that the solution (S) and the solution (S) in which the sample is mixed are defined as the same component and may be used interchangeably.

In addition, the sample collection unit 100 is for collecting the samples described above, and may be individually packaged and provided separately from the body portion 200. The shape of the sample collection unit 100 is a rod 110 of the same diameter having a length of approximately 10 to 20 cm, and a sterilized cotton swab 120 coupled to one end of the rod 110 in a round wound state. can be configured. The material of the cotton swab 120 may be preferably made of, for example, cotton or cloth that is soft to the touch and can sufficiently absorb secretions from the nasal cavity or oral cavity.

In addition, a stopper 130 capable of blocking communication between the sample extraction unit 210 and the outside may be coupled and provided at the other end of the rod 110. The shape and material of the stopper 130 need not be limited to any one, and for example, it may be formed of a soft rubber material and coupled by an interference fit method, or may be formed of synthetic resin and screwed together.

The cylinder part 220,

A piston unit 240 having a predetermined length and to be described later is inserted with a partition wall 230 provided with a nozzle 231 therebetween so that the solution S mixed in the sample extraction unit 210 described above passes therethrough. It may be formed in a hollow form so as to be able to communicate with the outside. The shape of the cylinder portion 220 may be formed in a polygonal or elliptical shape as well as a cylindrical shape as in the embodiment of the present invention without having to be set to any one shape.

4 is a diagram illustrating an operating state of a partition wall and a nozzle according to another embodiment of the present invention.

Referring to FIG. 4, the partition wall 230 functions to divide the space between the sample extraction unit 210 and the cylinder unit 220, and one side or both sides may be inclined, and the central part of the partition wall 230 has a solution. A nozzle 231 for transferring (S) may be formed.

The nozzle 231 has a check valve 231a that allows the flow of the solution S accommodated in the sample extraction unit 210 to flow in only one direction, that is, to be transferred only in the direction in which the cylinder unit 220 is located. may be provided.

In addition, a protrusion 221 for limiting the movement of the piston part 240 is formed on one side of the inner diameter of the cylinder part 220, and the solution S transferred by the movement of the piston part 240 flows into the bottom surface. A discharge hole 222 may be formed. The protrusion 221 and the discharge hole 222 will be described in detail together with the piston part 240 to be described later.

The piston part 240,

As described above, it is composed of a push rod member 241 that is inserted into the communicating portion of the cylinder portion 220 and slides within the cylinder portion 220, and a packing member 242 coupled to the front end of the push rod member 241. As a result, the solution (S) inside the sample extraction unit 210 can perform a basic function of blocking leakage to the cylinder unit 220.

In more detail with reference to FIG. 5 , the packing member 242 is formed such that a portion in contact with the partition wall 230 corresponds to the inclined surface of the partition wall 230, and a side surface of the packing member 242 is in contact with the packing member 242. The parts are tightly closed so that the fluid does not flow. The material of the packing member 242 may be a known material having elasticity including rubber, silicon, and the like.

In addition, the push rod member 241 may include a head portion coupled to the packing member 242 and a gripping portion that extends to the other side of the head portion and is grippable. In addition, a hooking hole 241a having a larger diameter than the outer circumference of the gripping part may be formed on one side of the outer circumference of the head part, and the hooking hole 241a is caught on the hooking protrusion 221 of the cylinder part 220 described above. Movement may be restricted.

In other words, when holding the gripping part of the push rod member 241 and pulling it to the communicating part of the cylinder part 220, the locking part 241a of the head part is caught by the hooking protrusion 221 of the cylinder part 220 and the movement is restricted. do. At this time, a cut groove 241a is formed at the boundary between the head portion and the gripping portion of the pushing member 241 so that the head portion and the gripping portion of the push rod member 241 are broken and separated when the pulling force of the gripping portion is added beyond this. can form Therefore, the packing member 242 caught on the protrusion 221 cannot move any more, so that the inside of the cylinder part 220 can be sealed in a vacuum state.

Meanwhile, referring to FIG. 6 , pressure is applied to the sample extraction unit 210 simultaneously with the movement of the piston unit 240, so that the received solution S can be transferred to the cylinder unit 220 through the nozzle 231. . Subsequently, the transported solution (S) may flow into the discharge hole 222 formed at the bottom of the cylinder portion 220 . At this time, in order to induce the discharge of the solution (S), guide grooves 222a formed concavely around the upper and lower sides of the discharge hole 222 may be formed. Therefore, the solution (S) flowing along the guide groove (222a) of the discharge hole (222) can be easily absorbed into the test strip (253) to be described later.

The result unit 250,

Formed on the lower surface of the cylinder portion 220 described above and having a test strip 253 that reacts when in contact with the solution (S) discharged through the discharge hole 222, the reaction of the test strip 253 is identified from the outside. You can indicate what you can do.

At this time, the bottom surface of the resultant unit 250, that is, the bottom area in contact with the ground may be formed flat. Therefore, the discharge of the solution S through the discharge hole 222 can be facilitated by the self-supporting diagnosis kit 1 .

Here, the test strip 253 may be a chromatographic analysis method known as a rapid test method, that is, an assay strip including a reactant capable of reacting with a target material to be detected and exhibiting a change, as an example. Of course, it is not limited thereto, and various changes may be applied as long as they are easy to diagnose, test, and detect.

One upper side of the test strip 253 may be supported in close contact with the bottom surface of the discharge hole 222 . That is, the bottom of the result unit 250 is provided with a tray 251 for seating the test strip 253, and the upper surface of the tray 251 supports the lower surface of the test strip 253 so that the test strip 253 is discharged through the hole 222 ) may further include a support protrusion 252 protruding upward so as to be in close contact at all times.

In addition, although not shown in the drawing, the support protrusion 252 may further include an elastic member (not shown) such as a plate spring so that elastic force is applied upward.

A method for diagnosing a specimen using the specimen insertion type diagnosis kit as described above will be described with reference to FIGS. 7A to 7E.

First, the individually packaged sample collection unit 100 is unpacked and samples are collected through the cotton swab 120. Subsequently, as shown in FIG. 7A, the sealing paper 211 attached to the front end of the sample extraction unit 210 is removed, and the cotton swab 120 with the sample previously smeared is introduced into the sample collection unit 100. In this case, it is preferable to use the body part 200 upright so that the solution (S) accommodated inside the sample extraction part 210 does not leak out.

And, as shown in FIG. 7B, the front end of the sample extraction unit 210 is sealed through the stopper 130 of the sample collection unit 100 and shaken so that the sample and the solution (S) are well mixed.

Subsequently, as shown in (a) of FIG. 7C, the push rod member 241 of the piston unit 240 is pulled to transport the solution S in the sample extraction unit 210 to the cylinder unit 220. At this time, as shown in (b) of FIG. 7C, in a state in which the hook 241a of the push rod member 241 is caught on the hook protrusion 221 of the cylinder part 220, the pulling force is applied to the push rod member 241 further. In addition, the gripping portion is separated from the head portion of the push rod member 241. Therefore, by fixing the position of the packing member 242 within the cylinder portion 220, the inside of the cylinder portion 220 can be sealed to a vacuum state.

Also, as shown in FIG. 7D, the solution S transported to the cylinder part 220 flows into the resultant part 250 through the discharge hole 222. In this case, it is preferable to lay down the main body 200 so that the solution S flows naturally by gravity.

Finally, Figure 7e shows the reaction result of the test strip 253 built in the outside of the body portion 200 as an example, and the solution (S) flowing into the result portion 250 through the discharge hole 222 is the test strip The test strip 253 that is in contact with the 253 and undergoes a chemical reaction can be visually confirmed by the user from the outside of the main body 200 . At this time, it is possible to more easily identify the reaction result of the test strip 253 through the enlarged display window 200a provided on an external portion of the main body 200.

Therefore, by providing a body portion 200 into which a sample can be injected and a test strip 253 that exhibits a chemical reaction upon contact with the sample inside the body portion 200, evaporation of the sample is prevented and contact with the outside occurs. It is possible to obtain an effect of preventing test results from being damaged.

In addition, by providing the solution (S) inside, it is possible to reduce the test time and increase the efficiency of work by providing a separate solution and reducing the process of contacting the sample.

As described above, in the detailed description of the present invention, specific embodiments have been described, but various modifications are possible without departing from the scope of the description. Therefore, the scope of the described content does not need to be limited to the described embodiments, and should be defined by not only the claims described later, but also those equivalent to these claims.

1: diagnostic kit 100: sample collection unit
110: rod 120: cotton swab
130: stopper 200: main body
200a: enlarged display window 210: sample extraction unit
211: sealing paper S: solution
220: cylinder part 221: stumbling block
222: discharge hole 222a: guide groove
230: bulkhead 231: nozzle
231a: check valve 240: piston part
241: push rod member 241a: hook
241b: cutting groove 242: packing member
250: result part 251: tray
252: support protrusion 253: test paper

Claims (11)

A body portion provided with an accommodation space therein;
a sample extraction unit provided on one side of the inside of the main body unit, communicating with the outside so that a sample can be introduced therein, and accommodating a solution to extract pathogens from the sample by mixing with the injected sample;
a cylinder part formed to communicate with the outside on the other side of the body part with a partition wall provided with a nozzle therebetween so that the solution mixed in the sample extraction part passes therethrough;
a piston unit that is inserted into the communicating portion of the cylinder unit and slides within the cylinder unit to close or open a nozzle provided in the partition wall; and
A discharge hole is formed at the bottom of the cylinder portion so that the solution transported into the cylinder portion flows by the sliding movement of the piston portion, and a test paper that reacts when in contact with the discharged solution is placed on the bottom of the discharge hole. Including; a result that displays the reaction of the test paper;
The piston unit is composed of a grippable push rod member and a packing member coupled to a front end of the push rod member,
The leakage of the solution from the sample extraction unit is blocked by blocking the nozzle of the partition through the packing member, and the solution is transported to the cylinder unit by applying pressure to the sample extraction unit by sliding the piston unit,
The push rod member is composed of a head portion coupled to the packing member and a gripping portion extending to the other side of the head portion and capable of being gripped,
A hooking hole having a larger diameter than the outer circumference of the gripping portion is formed on one side of the outer circumference of the head portion,
A locking protrusion protrudes along the inner diameter of one side of the inner diameter of the cylinder portion so that the locking hole is engaged.
When the gripping part of the push rod member is grasped and pulled with the communicated part of the cylinder part, the locking hole of the head part is caught on the locking protrusion of the cylinder part and the movement is restricted,
and a cutting groove at the boundary between the head portion and the gripping portion of the push rod member so that the head portion and the gripping portion are cut and separated when a force pulling the gripping portion is added.
According to claim 1,
The sample extraction unit,
A sample insertion-type diagnostic kit, wherein a sealing paper is attached to the frontmost part communicating with the outside so that the solution contained inside is vacuum-packed and sealed until it is opened.
According to claim 1,
One or both sides of the barrier rib is inclined, and a check valve opened and closed in only one direction is provided on either side of the nozzle formed in the center of the barrier rib.
delete delete delete According to claim 1,
The body part,
A sample insert type diagnostic kit formed of a transparent material so that the movement of the solution and the reaction of the test strip can be identified from the outside.
According to claim 1,
The discharge hole is
The specimen insertion type diagnostic kit further comprising: an induction groove formed concave on the upper side to induce discharge of the solution.
According to claim 1,
The result part,
A sample insertion type diagnostic kit in which the bottom area in contact with the ground is formed flat.
According to claim 1,
A tray for seating the test paper is provided at the bottom of the result unit,
The specimen insertion type diagnostic kit further comprising: a support protrusion protruding upward from the upper surface of the tray to support the lower surface of the test paper so that the test paper is always in close contact with the discharge hole.
According to claim 10,
The support protrusion,
The specimen insertion type diagnostic kit further comprising: an elastic member to which an elastic force is applied such that the test paper is always in close contact with the discharge hole.

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