WO2024071610A1

WO2024071610A1 - Absorbent pad cartridge and sample analysis system comprising same

Info

Publication number: WO2024071610A1
Application number: PCT/KR2023/009999
Authority: WO
Inventors: 서유진; 이원재; 여봉수; 정현준; 이도부; 박준희; 김동현; 박찬; 박범준; 박기범
Original assignee: 주식회사 진시스템
Priority date: 2022-09-26
Filing date: 2023-07-13
Publication date: 2024-04-04
Also published as: KR102540851B1

Abstract

The present invention relates to a sample analysis system. An absorbent pad cartridge and a sample analysis system comprising same, according to the present invention, can perform a PCR test by adding a collected sample into a tube containing a reagent after sample collection, and simply loading the tube into the cartridge without a separate mixing process, and thus have the effect of simplifying a preprocessing process performed by a user.

Description

Absorbent pad cartridge and sample analysis system including the same

The present invention relates to a sample analysis system, and more specifically, to a sample analysis system with a simplified preprocessing process.

PCR is a polymerase chain reaction, a molecular biology technology that replicates and amplifies desired parts of DNA. This allows researchers to selectively amplify only the specific DNA fragments they want in a short time from a DNA solution that is very complex and has an extremely small amount, such as the human genome, and is used for tasks that handle DNA such as molecular biology, medicine, criminal investigation, and classification of living things. It plays an extremely important role in the overall situation. In particular, as infectious diseases such as the COVID-19 virus spread recently, the need for PCR is expected to increase further.

However, as the need for PCR testing has increased, a situation has arisen in which users without expert knowledge have to perform PCR tests or PCR tests have to be performed in large quantities. Accordingly, in the conventional technology, self-test kits have been proposed that allow even non-professionals to easily perform PCR tests and can be prepared in large quantities. However, in the case of these self-test kits, the user collects a sample of the test target and collects it at a certain rate. It was inconvenient to use because it had to include an additional pretreatment process that required mixing with the reagent and dispensing it into a cartridge containing target particles.

The present invention was created to solve the above problems, and the purpose of the present invention is to perform a PCR test by simply placing the collected sample into a tube containing a reagent after collecting the sample and inserting it into the cartridge without a separate mixing process. The goal is to provide an absorbent pad cartridge that can simplify the preprocessing process performed by the user and a sample analysis system including the same.

In addition, by forming a single-line flow path through which the air inside the cartridge can flow and including vent holes at both ends of the flow path, the reagent received through the tube easily spreads to the absorption pad according to the difference in air pressure, and the pretreatment material and The aim is to provide a sample analysis system that can be mixed with target substances to react uniformly.

In addition, it provides a sample analysis system that allows for more accurate testing by including a filter that can absorb moisture and an insulating material that can prevent the temperature of the reagent inside the cartridge from increasing.

In order to solve the problems described above, the absorbent pad cartridge according to an embodiment of the present invention includes a receiving unit that receives a reagent containing a sample, and one side of a groove-shaped reaction section in which target particles reacting with the sample are accommodated. A flat-shaped plate included in the reaction unit, one end of which is in contact with the receiver, the other end of which is in contact with the reaction unit, and a reagent absorption pad including a pretreatment unit for pre-processing the sample, one end of which is coupled with the receiver and the reagent contained therein. It is characterized in that it includes an injection tube.

In addition, the plate is characterized by further including two or more vent holes that communicate with the reaction unit and suck or discharge air inside the reaction unit.

In addition, the reaction unit is characterized by including a pad fixing part, which is a groove formed on the lower surface of the plate and fixing the reagent absorption pad, and an air communication passage whose one end is in communication with the pad fixing part and the other end is in communication with one of the vent holes. Do it as

In addition, at least one of the vent holes is formed on the side of the receiver, but is formed above one end of the injection tube, and at least another one of the vent holes is formed through one side of the plate.

Additionally, the vent hole is characterized by having an anti-pollution filter inserted therein.

Additionally, the pad fixing portion is characterized by including at least one fixing step formed outward from one surface of the reaction portion.

In addition, the pad fixing unit includes at least one receiving groove formed inward from one surface of the reaction unit, and the target particles are accommodated within the receiving groove.

Additionally, the air communication passage is characterized by including a moisture absorption filter between the pad fixing portion and the vent hole.

Additionally, the air communication passage is characterized by including a heat insulating material between the pad fixing portion and the vent hole.

In addition, the receiver is characterized in that at least one groove or protrusion is formed on the inner surface, and the outer surface of the injection tube has a shape corresponding to the inner surface of the receiver.

Additionally, the injection tube is characterized by including a manual lever on the side that determines whether or not to inject a reagent containing the sample.

In addition, it includes a tube insertion groove into which the absorption pad cartridge and the injection tube can be inserted, an observation hole that opens toward the absorption pad cartridge to observe the sample reaction status, and includes a fixing part that fixes the position of the plate and the injection tube. It is characterized by:

In addition, it further includes an actuator that determines whether the injection tube is open, and the tube insertion groove is open on one side, and the actuator and the injection tube are coupled to the open side.

Additionally, the observation hole is characterized in that it is formed at a location corresponding to the reaction unit.

The absorbent pad cartridge of the present invention with the above configuration and the sample analysis system including the same can perform a PCR test by simply placing the sample collected after sample collection into a tube containing a reagent and inserting it into the cartridge without a separate mixing process. This has the effect of simplifying the preprocessing process performed by the user.

In addition, by forming a single-line flow path through which the air inside the cartridge can flow and including vent holes at both ends of the flow path, the reagent received through the tube easily spreads to the absorption pad according to the difference in air pressure, and the pretreatment material and It has the effect of allowing it to react uniformly by mixing with the target material.

In addition, it has the effect of enabling more accurate inspection by including a filter that can absorb moisture and an insulator that can prevent the temperature of the reagent from rising inside the cartridge.

1 is an exploded perspective view of the absorbent pad cartridge of the present invention.

Figure 2 is a top view of the reagent absorption pad of the present invention.

Figure 3 is a top view of the plate of the present invention.

Figure 4 is a cross-sectional view of the absorbent pad cartridge of the present invention.

Figure 5 is an exploded perspective view of the sample analysis system of the present invention.

Figure 6 is a perspective view of the sample analysis system of the present invention.

Hereinafter, the technical idea of the present invention will be described in more detail using the attached drawings. Prior to this, the terms or words used in this specification and claims should not be construed as limited to their usual or dictionary meanings, and the inventor should appropriately define the concept of terms in order to explain his or her invention in the best way. It must be interpreted as meaning and concept consistent with the technical idea of the present invention based on the principle of definability.

Hereinafter, the basic configuration of the absorbent pad cartridge 1000 of the present invention will be described with reference to FIGS. 1 and 2.

As shown in FIG. 1, the absorbent pad cartridge 1000 of the present invention may include a plate 100 in the shape of a plate. The plate 100 may include a receiving unit 110 protruding from one end. It is preferable that the plate 100 receives the reagent mixed with the sample through the receiving unit 110. Additionally, the plate 100 may include a groove-shaped reaction portion 120 on one surface that accommodates target particles that react with the sample. A reagent absorption pad 200 that absorbs the reagent mixed with the sample received through the receiving unit 110 may be inserted and coupled to the reaction unit 120. In more detail, it is preferable that a through hole communicating with the receiving unit 110 is formed at one end of the reaction unit 120.

In addition, the absorbent pad cartridge 1000 of the present invention preferably includes an injection tube 300, one end of which is coupled to the receiver 110, and a reagent is accommodated therein. A sample may be added to the injection tube 300 while the reagent is accommodated therein. Accordingly, the injection tube 300 may be open and closed at the top so that a sample or swab containing the sample can be accommodated, and may include sufficient space inside. By including this configuration, the plate 100 can receive samples and reagents from the injection tube 300 through the receiving unit 110, and the received reagents flow to one end of the reaction unit 120 through the through hole. and can be absorbed into the reagent absorption pad 200 inserted into the reaction unit 120.

In addition, the plate 100 preferably further includes two or more vent holes 130 that communicate with the reaction unit 120 and suction or discharge air inside the reaction unit 120. By forming the vent hole 130, a pressure difference may occur inside the plate 100 when samples and reagents are received from the tube, and the internal air may flow according to the direction in which the reaction portion 120 formed in the plate 100 is formed. It can be fluid. Accordingly, the sample and reagent can be spread in the longitudinal direction of the reagent absorption pad 200, and can be mixed with the pretreatment material and the target material to react uniformly.

In addition, a pollution prevention filter 131 is inserted into the vent hole 130 to block pollutants flowing in from external air. Accordingly, it is possible to prevent the accuracy of the PCR test from being lowered due to external contaminants and at the same time allow the inflow and outflow of air through the vent hole 130 to keep the flow direction of the sample and reagent constant.

In addition, the plate 100 includes an insulating material 150 therein, which prevents the temperature inside the reaction unit 120 from increasing and prevents moisture in the reaction unit 120 from evaporating, and the moisture absorption filter 140 ), even if the moisture in the reaction unit 120 is evaporated, the evaporated moisture is prevented from being transferred to the reagent absorption pad 200, thereby increasing the accuracy of the PCR test.

At this time, as shown in FIG. 2, it is preferable that one end of the reagent absorption pad 200 inserted into the reaction unit 120 is in contact with the reception unit 110 and the other end is in contact with the reaction unit 120. In addition, the reagent absorption pad 200 may include a preprocessing unit 210 for preprocessing the sample between one end and the other end. In the pretreatment unit 210, a pretreatment material (Premix) containing a material that amplifies the DNA information of the sample is dried and attached to the upper surface of the reagent absorption pad 200 (the surface facing the reaction unit 120). In the pretreatment unit 210, the pretreatment material is dried and placed, thereby generating an osmotic pressure phenomenon between the reagent and the reagent, allowing the reagent absorption pad 200 to more easily absorb the reagent, and the absorbed sample and reagent By passing between the particles of the pretreatment material, it can be naturally mixed and pretreated at the same time. Accordingly, an accurate test can be performed even without the user having to go through a preprocessing process of mixing the sample and reagent in advance.

Hereinafter, the plate 100 of the present invention will be described with reference to FIG. 3.

As shown in FIG. 3, a groove-shaped reaction portion 120 may be formed on the lower surface of the plate 100. The reaction unit 120 includes a pad fixing unit 121, which is a groove formed on the lower surface of the plate 100 and fixing the reagent absorption pad 200, one end of which is in communication with the pad fixing unit 121, and the other end of which is a vent hole ( It is preferable to include an air communication passage 122 that communicates with any one of 130). At this time, the plate 100 can prevent the reagent injected inside from leaking by including a film of a predetermined thickness on the surface where the groove is formed. By forming the reaction unit 120 in this way, when the sample and reagent are injected into the pad fixing unit 121, the air inside can be discharged to the outside of the plate 100 through the air communication passage 122, Samples and reagents may be absorbed in the longitudinal direction of the reagent absorption pad 200.

At this time, the pad fixing part 121 may include at least one receiving groove formed inward from one surface of the reaction unit 120 (the surface facing the reagent absorption plate 100). It is preferable that target particles that react with the sample are accommodated inside the receiving groove (121b). At this time, it is preferable that each receiving groove is formed at a predetermined distance from each other in the longitudinal direction of the reagent absorption pad 200. Accordingly, the larger the amount of reagent, the longer it is absorbed in the longitudinal direction of the reagent absorption pad 200, and it can sequentially react with the target particles in each receiving groove (121b), and the reaction can occur by contacting more target particles. .

Furthermore, the pad fixing part 121 preferably includes at least one fixing step 121a formed outward from one surface of the reaction unit 120 (the surface facing the reagent absorption pad 200). In more detail, it is preferable that the fixed step 121a is formed in the area where the pre-processing unit 210 is disposed and is formed to contact the pre-processing unit 210. By including the fixed step 121a, the position of the reagent absorption pad 200 can be fixed, and even if a large amount of reagent is suddenly added, the reagent does not overflow into the upper part of the pretreatment unit 210, and the pretreatment material particles in the pretreatment unit 210 Samples and reagents can pass through the gap.

In addition, the air communication passage 122 preferably includes an insulating material 150 and a moisture absorption filter 140 between the pad fixing portion 121 and the vent hole 130. Accordingly, the heat insulating material 150 prevents the temperature rise inside the reaction unit 120 from being evaporated, and the moisture absorption filter 140 prevents the moisture within the reaction unit 120 from being evaporated. Even if moisture evaporates, the accuracy of the PCR test can be improved by preventing the evaporated moisture from being transferred to the reagent absorption pad 200. In addition, by including the moisture absorption filter 140, it is possible to prevent water containing samples and reagents from flowing from the inside to the outside and ultimately prevent the inside and outside of the plate 100 from being contaminated. This is also meaningful as a function that complements the pollution prevention filter 131 described above.

In more detail, the air communication passage 122 may include a groove formed with an area larger than the average air flow width so that the insulation material 150 and the moisture absorption filter 140 can be inserted. The insulation material 150 and the moisture absorption filter 140 may be inserted into the groove formed in the air communication passage 122 in the order of moisture absorption filter 140 - insulation material 150. At this time, it is preferable that the position of the moisture absorption filter 140 is determined so that the air flowing through the air communication passage 122 passes through the side of the moisture absorption filter 140. The insulating material 150 is preferably inserted in contact with the moisture absorption filter 140 and preferably insulates the air passing through the moisture absorption filter 140.

Hereinafter, the coupling relationship between the receiver 110 and the tube and the reaction path inside the plate 100 will be described with reference to FIG. 4.

As described above, the plate 100 of the present invention preferably communicates with the reaction unit 120 and further includes two or more vent holes 130 for sucking or discharging air inside the reaction unit 120. At this time, at least one of the vent holes 130 is preferably formed on the side of the receiving unit 110, and at least one other of the vent holes 130 communicates with the other end of the air communication passage 122, and is connected to the plate ( 100) is preferably formed through one side.

At this time, the vent hole 130 formed on the side of the receiving unit 110 is preferably formed above one end of the injection tube 300. Accordingly, when the speed at which the reagent is discharged from the injection tube 300 is greater than the speed at which the reagent is absorbed into the absorption pad, the reagent can be prevented from overflowing and leaking along the vent hole 130 inside the receiving unit 110. .

In addition, the receiving unit 110 preferably has at least one groove or protrusion formed on the inner surface, and the outer surface of the injection tube 300 is preferably shaped to correspond to the inner surface of the receiving unit 110. At this time, the outer surface of the injection tube 300 may be made of an elastic member, the injection tube 300 and the receiver 110 may be fitted with each other, and a predetermined gap may be formed between the injection tube 300 and the receiver 110. Since pressure can be generated, the injection tube 300 and the receiver 110 can be more firmly coupled.

Furthermore, the injection tube 300 preferably includes a manual lever 310 on the side that determines whether or not to inject a reagent containing the sample. Accordingly, the user inserts a sample or a sterile swab containing the sample into the inside of the injection tube 300 and opens the injection tube 300 with the manual lever 310, thereby injecting the reagent and sample inside the injection tube 300 into the plate (100). ) can be injected into the interior.

Hereinafter, the sample analysis system 1 of the present invention will be described in more detail with reference to FIGS. 5 and 6.

As shown in Figure 5, the sample analysis system 1 of the present invention may include an absorption pad cartridge 1000, and also a tube insertion groove 2100 into which the injection tube 300 can be inserted, and an absorption pad cartridge 1000. It is preferable to include an observation hole 2200 that is open toward the pad cartridge 1000 to observe the sample reaction status, and to include a fixing part 2000 that fixes the positions of the plate 100 and the injection tube 300. At this time, the fixing part 2000 may include a part that is inserted between the absorption pad cartridge 1000 and the injection tube 300 and a part that covers and protects the side of the absorption pad cartridge 1000. By including the fixing part 2000, the coupling position between the relatively large injection tube 300 and the absorption pad cartridge 1000 can be more firmly supported.

At this time, as shown in FIG. 6, the sample analysis system 1 of the present invention may further include an actuator that determines whether the injection tube 300 is open. One side of the tube insertion groove 2100 is open, and the actuator and the injection tube 300 are preferably coupled to the open side. Additionally, the observation hole 2200 is preferably formed at a location corresponding to the reaction unit 120. In addition, it may include a camera insertion groove 2300 formed at a location including the side of the tube insertion groove 2100 and the area where the observation hole 2200 is formed. A camera is inserted into the camera insertion groove 2300 to capture reaction information generated from the absorption pad cartridge 1000 through the observation hole 2200. At this time, the plate 100 is made of a transparent material so that reaction information inside the plate 100 can be observed through a camera.

The technical idea of the present invention should not be interpreted as limited to the above-described embodiments. Not only is the scope of application diverse, but various modifications can be made at the level of those skilled in the art without departing from the gist of the present invention as claimed in the claims. Therefore, such improvements and changes fall within the scope of protection of the present invention as long as they are obvious to those skilled in the art.

Claims

A plate-shaped plate including a receiver for receiving a reagent containing a sample, and including a groove-shaped reaction section on one side of which target particles reacting with the sample are accommodated;

A reagent absorption pad that is inserted into the reaction unit, has one end in contact with the receiving unit, the other end in contact with the reaction unit, and includes a pretreatment unit for preprocessing the sample; and

An absorption pad cartridge comprising an injection tube, one end of which is coupled to the receiving unit and a reagent contained therein.
According to clause 1,

The plate is,

An absorbent pad cartridge further comprising two or more vent holes that communicate with the reaction unit and suck in or discharge air inside the reaction unit.
According to clause 2,

The reaction unit,

a pad fixing portion, which is a groove formed on the lower surface of the plate to secure the reagent absorption pad;

An absorbent pad cartridge comprising an air communication passage whose one end is in communication with the pad fixing part and the other end in communication with one of the vent holes.
According to clause 2,

At least one of the vent holes is,

It is formed on a side of the receiver, and is formed above one end of the injection tube,

At least one other of the vent holes is

An absorbent pad cartridge, characterized in that it is formed through one side of the plate.
According to clause 2,

The vent hole is,

An absorbent pad cartridge characterized by an anti-pollution filter inserted therein.
According to clause 3,

The pad fixing part,

An absorbent pad cartridge comprising at least one fixed step formed outward from one surface of the reaction unit.
According to clause 3,

The pad fixing part,

It includes at least one receiving groove formed inward on one surface of the reaction unit,

An absorbent pad cartridge, characterized in that the target particles are accommodated inside the receiving groove.
According to clause 3,

The air communication path is,

An absorbent pad cartridge comprising a moisture absorption filter between the pad fixing portion and the vent hole.
According to clause 3,

The air communication path is,

An absorbent pad cartridge comprising an insulating material between the pad fixing portion and the vent hole.
According to clause 1,

The receiver,

At least one groove or protrusion is formed on the inner surface,

An absorbent pad cartridge, characterized in that the outer surface of the injection tube has a shape corresponding to the inner surface of the receiver.
According to clause 1,

The injection tube is

An absorbent pad cartridge comprising a manual lever on the side that determines whether or not to inject a reagent containing the sample.
In the sample analysis system including the absorbent pad cartridge of claim 1,

the absorbent pad cartridge; and

a tube insertion groove into which the injection tube can be inserted;

A sample analysis system comprising an observation hole that is open toward the absorption pad cartridge to observe the sample reaction status, and a fixing part that fixes the positions of the plate and the injection tube.
According to clause 12,

It further includes an actuator that determines whether the injection tube is open or not,

The tube insertion groove is open on one side, and the actuator and the injection tube are coupled to the open side.
According to clause 12,

The observation hall is,

A sample analysis system characterized in that it is formed at a location corresponding to the reaction unit.