Sealed disease diagnostic test kit

Abstract

A sealed disease diagnostic test kit (10) for preventing foreign body penetration according to an embodiment of the present disclosure may include: a body (100) for accommodating a syringe needle (110); a chamber array (200) composed of multiple chambers connected to the body (100) such that one end of the syringe needle (110) is located at the opening of the chamber; and a cover member connected to at least one of the body (100) and the chamber array (200) and capable of being opened and closed.

Description

Technical Field

[0001] The technical concept disclosed herein relates to a disease diagnostic testing kit, and more specifically, to a sealed disease diagnostic testing kit. Background Technology

[0002] Existing equipment for molecular or immunodiagnostic purposes is designed for automated or semi-automated testing of large numbers of samples. This type of equipment is primarily deployed in hospital systems dominated by large-scale facilities, making it difficult to test small numbers of samples and thus limiting its ability to handle emergency situations.

[0003] Therefore, there is a growing trend towards introducing point-of-care (POC) testing systems for examining small numbers of samples. POC systems, which perform molecular or immunodiagnostic tests in real-time on-site, utilize random sampling to minimize hospital-acquired infections.

[0004] Overseas, the demand for POC systems is increasing in areas with low hospital coverage, especially in the United States and Europe, where POC systems are more price-competitive compared to examination centers with large equipment.

[0005] However, this POC system still requires many steps and consumes a significant amount of time from sample collection to confirming the test results. For a POC test, sample collection, reagent aliquoting, nucleic acid extraction, PCR reagent aliquoting, sealing and centrifugation, PCR amplification, and analysis must be performed. Although this reduces the time required compared to large-scale automated equipment, it still takes a considerable amount of time.

[0006] Meanwhile, the POC system requires on-site sample collection for real-time molecular or immunodiagnostic testing, making it more susceptible to contamination by infectious agents compared to in-hospital diagnostics. Summary of the Invention

[0007] The problem the invention aims to solve The technical concept of this disclosure aims to solve the problem of providing a detection kit that prevents contamination by infectious agents while rapidly performing molecular and immunodiagnostic procedures.

[0008] means for solving problems A sealed disease diagnostic test kit 10 for preventing foreign body penetration according to an embodiment of the present disclosure may include: a main body 100 for housing a syringe needle 110; a chamber array 200, composed of multiple chambers, connected to the main body 100 such that one end of the syringe needle 110 is located at the opening of the chamber; and a cover component connected to at least one of the main body 100 and the chamber array 200 and capable of being opened and closed.

[0009] According to one embodiment, it may have the following features: the chamber array 200 can be installed on the body 100 so that the contents of the chamber can be discharged into or introduced into the chamber through one end of the syringe needle 110.

[0010] According to one embodiment, the cover component may include a first cover component 310, which is connected to the body 100 and is openable to expose the other end of the syringe needle 110 to the outside.

[0011] According to one embodiment, the body 100 may have the following features: a curved guide groove 120 is formed to guide the rotation of the first cover member 310 so that the first cover member 310 rotates toward the other end of the syringe needle 110 to cover it; and a straight guide groove 130 is formed to guide the linear movement of the first cover member 310 so that the first cover member 310 moves linearly toward the other end of the syringe needle 110.

[0012] According to one embodiment, the cover component may include a second cover component 320, which is configured to switch between the body 100 and the chamber array 200 to expose the opening of the chamber toward the interior of the body 100.

[0013] According to one embodiment, it may have the following features: when the second cover member 320 is open, the syringe needle 110 can be accessed by the chamber; when the second cover member 320 is closed, the chamber is blocked from accessing the syringe needle 110.

[0014] According to one embodiment, the second cover component 320 may have the following feature: the opening and closing of the second cover component 320 is determined according to the direction in which the chamber array 200 slides relative to a specified position.

[0015] According to one embodiment, it may have the following features: in the second cover member 320, an elongated groove 322 is formed in an oblique direction with respect to the sliding direction; the protrusion formed in the chamber array 200 is inserted into and connected to the elongated groove 322 formed in the second cover member 320, and the second cover member 320 moves in the oblique direction corresponding to the moving direction of the protrusion.

[0016] Invention Effects According to an exemplary embodiment of the present disclosure, the detection kit is a multi-functional detection kit that can simultaneously perform the functions of a molecular diagnostic detection kit and an immunodiagnostic detection kit, while effectively preventing leakage of infectious sources to the outside of the detection kit.

[0017] The effects obtainable from the exemplary embodiments of this disclosure are not limited to those mentioned above, and other effects not mentioned can be clearly derived and understood by those skilled in the art to which the exemplary embodiments of this disclosure pertain from the following description. That is, unintended effects arising from implementing the exemplary embodiments of this disclosure can also be derived by those skilled in the art from the exemplary embodiments of this disclosure. Attached Figure Description

[0018] Figure 1 This is a diagram illustrating a detection box according to an embodiment of the present disclosure.

[0019] Figure 2 This is a diagram showing a first cover component according to one embodiment.

[0020] Figure 3 This is a diagram illustrating the structure of a chamber array for moving a second cover component according to one embodiment.

[0021] Figure 4 This is a diagram illustrating an embodiment of a second cover component mounted on a chamber array.

[0022] Figure 5 This is a diagram illustrating an embodiment of switching the chamber array with the second cover component installed in the chamber array.

[0023] Figure 6a This is an embodiment showing the second cover component in an open state, according to one example; Figure 6b This is an embodiment shown in the closed state of the second cover component.

[0024] Figures 7 to 9 This is a diagram illustrating an embodiment of a sealed detection box body and chamber array according to one embodiment. Detailed Implementation

[0025] The following describes various embodiments of the present disclosure in conjunction with the accompanying drawings. Various modifications and embodiments of the present disclosure can be applied, and specific embodiments are illustrated in the drawings, along with related detailed descriptions. However, this is not intended to limit the various embodiments of the present disclosure to specific implementations, but should be understood to include all changes and / or equivalents and even substitutions within the scope of the ideas and techniques of the various embodiments of the present disclosure. Regarding the description of the drawings, similar reference numerals are used for similar components.

[0026] In the various embodiments of this disclosure, the terms "comprising" or "having" should be understood as specifying the presence of features, numbers, steps, actions, components, parts, or combinations thereof recorded in the specification, without excluding in advance the presence or additional possibilities of one or more other features or numbers, steps, actions, components, parts, or combinations thereof.

[0027] In various embodiments of this disclosure, expressions such as "or" include any and all combinations of the words listed together. For example, "A or B" may include A, may include B, or may include both A and B.

[0028] The terms "first," "second," "first," or "second," etc., used in the various embodiments of this disclosure can describe various components of various embodiments, but do not limit the corresponding configuration. For example, the terms do not limit the order and / or importance of components, and may be used to distinguish one component from other components.

[0029] When referring to a component as being "connected" or "in contact" with another component, it can mean that the component is directly connected to or in contact with the other component, but it can also be understood that there may be other new components between the component and the other component.

[0030] In embodiments of this disclosure, terms such as "module," "unit," and "section" are used to refer to a component that performs at least one function or action. Such a component may be implemented in hardware or software, or in a combination of hardware and software. Furthermore, multiple "modules," "units," or "sections," except where they need to be implemented separately by individual specific hardware, may be integrated into at least one module or chip and implemented using at least one processor.

[0031] Terms used in common usage and as defined in dictionaries should be interpreted as having the same meaning as in the relevant technical articles, and should not be interpreted in an ideal or overly formal sense unless explicitly defined in the various embodiments of this disclosure.

[0032] Hereinafter, embodiments of the present disclosure will be described in detail with reference to the accompanying drawings.

[0033] Figure 1 This is a diagram illustrating the detection box 10 according to an embodiment of the present disclosure.

[0034] Reference Figure 1The detection box 10 according to an embodiment of the present disclosure may consist of a main body 100, a chamber array 200, and a cover component. The cover component may be an adjustable switch to allow selective access from external devices. Alternatively, the cover component may also be adjustable to selectively allow access between components within the detection box 10. Exemplarily, a portion of the cover component may also be configured to adjust the access between the main body 100 and the chamber array 200.

[0035] The main body 100 can be configured with a syringe needle to connect the external device to the chamber array 200. The syringe needle 110 can be configured to connect to a syringe pump, which is an external device that supplies or introduces a precise amount of fluid via a syringe. That is, in embodiments of this disclosure, when the syringe pump and the detection cartridge 10 are connected via the syringe needle 110, the syringe pump introduces or supplies contents stored in the chamber array 200 to the chamber array 200.

[0036] The chamber array 200 can be configured to connect multiple chambers and can be installed on the lower part of the main body 100. When installed, the chamber array 200 can be detached from the main body 100 depending on the actions of the user or the diagnostic equipment. The types of chambers can be distinguished according to the shape of the chambers and / or the types of reagents loaded in the chambers.

[0037] Exemplarily, the chamber array 200 may include: a sample chamber for sealing a sample solution; a buffer chamber for loading solutions for lysis and binding to perform molecular diagnostics on a sample solution injected via syringe needle 110; a mixing chamber; a washing chamber; a buffer chamber for loading solutions for elution; and a PCR chamber for performing PCR. Additionally, it may include an extraction freeze-drying chamber for extracting the target analyte from the sample solution and performing freeze-drying.

[0038] However, the types of chambers disclosed herein are not limited to these, but may include all types of chambers that can hold reagents or store contents.

[0039] According to one embodiment, the syringe needle 110 can correspond one-to-one with the chambers of the chamber array 200. Specifically, one end of the syringe needle 110 can be located at a position corresponding to the opening of a chamber. In this case, the syringe needle 110 or the chamber array 200 can slide in one direction while being interconnected. The direction in which the syringe needle 110 or the chamber array 200 slides can be the direction in which the syringe needle 110 is moved to the opening of an adjacent chamber.

[0040] Exemplarily, the syringe needle 110 is capable of moving in the direction of an adjacent chamber while located within the body 100. However, embodiments of movement of the syringe needle 110 or the chamber array 200 in the detection cartridge 10 of this disclosure are not limited to this, but include all methods of moving the syringe needle 110 to be located in the plurality of chambers constituted by the chamber array 200 according to the actions of the user or diagnostic equipment.

[0041] Figure 2 This is a diagram showing a first cover member 310 according to one embodiment.

[0042] Reference Figure 2 The first cover component 310 is mounted on the upper part of the main body 100 and can be opened and closed by rotating about any axis. When the first cover component 310 is open, the other end of the syringe needle 110 inside the main body 100 can be exposed to the outside. The other end of the syringe needle 110 is located in the opposite direction to the first end of the syringe needle 110 and can form an opening for connection with the syringe pump. That is, when the first cover component 310 is open, the syringe needle 110 inside the main body 100 can be exposed to the outside, and when the first cover component 310 is closed, the syringe needle 110 is prevented from being exposed to the outside.

[0043] According to one embodiment, the first cover member 310 may have a first protrusion 311 and a second protrusion 312. The first protrusion 311 can be inserted into a curved guide groove 120 formed in the main body 100, and the second protrusion 312 can be inserted into a straight guide groove 130 formed in the main body 100. The first cover member 310 may rotate as the first protrusion 311 moves along the curved guide groove 120. At this time, the rotation center of the first cover member 310 may be the second protrusion 312. When the second protrusion 312 moves to the uppermost end along the straight guide groove 130 and is fixed, the first protrusion 311 may move along the curved guide groove 120.

[0044] In other words, the curved guide groove 120 can be part of an arc centered at the uppermost end of the straight guide groove 130, and can be moved only when the second protrusion 312 is located at the uppermost end of the straight guide groove 130. Accordingly, if the second protrusion 312 is not at the uppermost end of the straight guide groove 130, the first cover member 310 cannot be rotated to close.

[0045] According to one embodiment, a tension spring may be installed on the first protrusion 311, and the tension spring may be connected to the opposite side of the main body 100 where the open first cover member 310 is located. That is, it can extend when the first cover member 310 is open and compress when the first cover member 310 is closed.

[0046] according to Figure 2 In this embodiment, the upper part of the main body 100 can be opened by rotating the first cover member 310 counterclockwise, and the upper part of the main body 100 can be closed by rotating the first cover member 310 clockwise. When the first cover member 310 is closed by rotating clockwise, the second protrusion 312 can be lowered along the straight guide groove 130 by a person or diagnostic equipment. When the second protrusion 312 is lowered, the first cover member 310 may not rotate because the second protrusion 312 is not at the center of curvature of the curved guide groove 120.

[0047] According to one embodiment, the first cover component 310 may further include a locking button, which protrudes through a groove formed in the body 100. When the locking button is exposed outside the body 100 without being pressed, the rotation, raising, and lowering of the first cover component 310 can be locked. The locking button can be released by pressing it with pressure by a user or diagnostic equipment, thereby enabling the rotation, raising, and lowering of the first cover component 310.

[0048] According to one embodiment, a curved guide groove 120 and a straight guide groove 130 may be formed on a first side of the main body 100, and a groove for accommodating a locking button may be formed on a second side opposite to the first side.

[0049] Figure 3 This is a diagram illustrating the structure of a chamber array 200 for moving a second cover component 320 according to one embodiment.

[0050] Reference Figure 3 A perspective view of the main body 100 shows that a first cover component 310 can be installed on the upper part of the main body 100, and a second cover component 320 and a chamber array 200 can be installed on the lower part of the main body 100. The second cover component 320 can be disposed between the chamber array 200 and the main body 100, and when the chamber array 200 is closed by the second cover component 320, it can prevent the contents loaded inside the chamber array 200 from falling into the main body 100.

[0051] According to one embodiment, the chamber array 200 installed on the lower part of the main body 100 can slide in the width direction of the main body 100 when installed. At this time, the chamber array 200 and the second cover member 320 can be connected by a protrusion and a long groove 322, and the opening and closing of the second cover member 320 connected to the chamber array 200 can be determined according to the direction of movement of the chamber array 200.

[0052] At this time, a slot 210 can be formed in the chamber array 200. Exemplarily, the slot 210 is locked by an internal component of the diagnostic device on which the test cartridge 10 is installed, allowing the chamber array 200 to slide in the width direction. That is, after the test cartridge 10 is installed in the diagnostic device, the chamber array 200 can be automatically closed after the reagent or contents loaded in the chamber array 200 are introduced or discharged into the chamber array 200 by the action of the diagnostic device.

[0053] Accordingly, the detection box 10 according to the embodiments of the present disclosure can initially prevent the source of infection from leaking to the outside by means of the first cover component 310, and can further prevent the source of infection from leaking from the chamber array 200 by means of the second cover component 320. However, the detection box 10 according to the embodiments of the present disclosure may not only include both the first cover component 310 and the second cover component 320, but may also include only either the first cover component 310 or the second cover component 320 to prevent the source of infection from leaking.

[0054] Figure 4 This is a diagram illustrating an embodiment in which a second cover component 320 is mounted on a chamber array 200.

[0055] Reference Figure 4 In the second cover component 320, an elongated groove 322 may be formed in an oblique direction relative to the sliding direction of the chamber array 200. The sliding direction of the chamber array 200 may be the width direction of the main body 100, and the oblique direction may be the direction in which the main body 100 is rotated by a predetermined angle relative to the width direction.

[0056] The protrusion formed in the chamber array 200 is inserted into the elongated groove 322 formed in the second cover member 320. When the chamber array 200 slides, the second cover member 320 can move in an oblique direction corresponding to the moving direction of the protrusion.

[0057] With the second cover member 320 covering the chamber array 200, the syringe needle 110 can be configured in a predetermined position, and the second cover member 320 can form a cavity 321 corresponding to the thickness of the syringe needle 110.

[0058] That is, reagents or contents can be introduced or exported through one end of the syringe needle 110. After the introduction / export operation is completed, one end of the syringe needle 110 can be positioned in the placement groove 220 at a predetermined depth to prevent the intrusion of foreign objects. After one end of the syringe needle 110 is placed in the placement groove 220, the chamber array 200 can be covered by the second cover member 320. If the cavity 321 corresponding to the thickness of the syringe needle 110 is not formed in the second cover member 320, the movement of the second cover member 320 may be incomplete because the syringe needle 110 can cause the movement of the second cover member 320 to be incomplete.

[0059] Simultaneously, the insertion / extraction action can continue only if the second cap component 320 does not cover the chamber array 200 while the insertion / extraction action via the syringe needle 110 is not yet completed. Accordingly, in the second cap component 320 of this disclosure, the cavity 321 is located at a position corresponding to the placement slot 220 where the syringe needle 110 is to be placed after the insertion / extraction action is completed, thereby preventing the second cap component 320 from accidentally covering the chamber array 200.

[0060] Accordingly, since the second cover component 320 of this disclosure forms a cavity 321 corresponding to the thickness of the syringe needle 110, leakage of the source of infection from the chamber array 200 can be prevented while the syringe needle 110 is placed in the chamber array 200.

[0061] Figure 5 This is a diagram illustrating an embodiment of switching the chamber array 200 with the second cover component 320 installed in the chamber array 200; Figure 6a This is an embodiment showing the second cover component 320 in an open state; Figure 6b This is an embodiment shown in the closed state of the second cover component 320.

[0062] Reference Figure 5 When the action of introducing / extracting reagents or contents through the syringe needle 110 is completed, the syringe needle 110 can be moved to a designated position with a groove. At this time, the user or diagnostic equipment can adjust the chamber array 200 so that the second cover member 320 covers the opening of the chamber array 200.

[0063] For example, the diagnostic device can fasten a fastening member that matches a slot 210 formed on the lower part of the chamber array 200 to the slot 210, and the fastening member can move in the -x direction, thereby enabling the chamber array 200 to slide in the -x direction.

[0064] At this time, the protrusions formed on the chamber array 200 can be inserted into the elongated groove 322 formed on the second cover member 320. The elongated groove 322 can be formed by tilting at a predetermined angle towards the front of the main body 100, with the direction of sliding of the chamber array 200 as the main direction.

[0065] To cover the chamber array 200, the second cover member 320 should move in the +y direction, but the chamber array 200 slides in the -x direction, resulting in an inconsistency in the direction of movement. Accordingly, the elongated slot 322 of this disclosure can extend in a direction between the -x and +y directions, thereby converting the movement of the chamber array 200 in the -x direction into the movement of the second cover member 320 in the +y direction.

[0066] Reference Figure 6aSince the second cover component 320 is located behind the main body 100, the syringe needle 110 can be located in the chamber array 200; see reference Figure 6b Since the second cover component 320 is located in the front direction of the main body 100, leakage of infection sources from the chamber array 200 can be prevented.

[0067] Figures 7 to 9 This is a diagram illustrating an embodiment of the body 100 and chamber array 200 of the sealing detection box 10.

[0068] Reference Figure 7 According to one embodiment, the main body 100 of the detection cartridge 10 may further include a sample injection port 140. The sample injection port 140 may be connected to a tube facing the chamber direction to inject a sample into at least a portion of the chambers.

[0069] Reference Figure 8 According to one embodiment, the detection box 10 has a film 150 attached to one side of the main body 100. The film 150 is sealed by heat melting to prevent foreign objects from entering the interior of the main body 100.

[0070] Reference Figure 9 The chamber array 200 according to one embodiment can be sealed with waterproof tape 160. Exemplarily, when the chamber array 200 is removed from the body 100 of the detection box 10, the waterproof tape 160 can be attached to the upper part of the chamber array 200 to prevent leakage of the source of infection.

[0071] As described above, exemplary embodiments are disclosed in the accompanying drawings and specification. While specific terminology has been used to describe embodiments in this specification, such terminology is used only for the purpose of illustrating the technical concept of the invention and is not intended to limit the meaning or to fall within the scope of the disclosure as set forth in the claims. Therefore, it will be understood by those skilled in the art that various modifications and equivalent embodiments can be implemented thereby. Consequently, the true scope of protection of this disclosure should be defined by the technical concept of the claims.

Claims

1. A sealed diagnostic test kit (10) for preventing the leakage of infectious agents to the outside, comprising: Body (100) accommodates syringe needle (110). A chamber array (200), composed of multiple chambers, is connected to the main body (100), such that one end of the syringe needle (110) is located at the opening of one of the chambers; and The cover component is connected to at least one of the main body (100) and the chamber array (200) for switching.

2. The sealed diagnostic test box (10) according to claim 1, characterized in that, The chamber array (200) is mounted on the body (100) to discharge or introduce contents into the chambers through one end of the syringe needle (110) into the opening of the chambers.

3. The sealed diagnostic test box (10) according to claim 1, characterized in that, The cover component includes a first cover component (310). The first cap component (310) is connected to the body (100) and is switched on and off to expose the other end of the syringe needle (110) to the outside.

4. The sealed diagnostic test box (10) according to claim 3, characterized in that, The main body (100) is, A curved guide groove (120) is formed to guide the rotation of the first cover component (310) so that the first cover component (310) rotates toward the other end of the syringe needle (110) to cover it; a straight guide groove (130) is formed to guide the linear movement of the first cover component (310) so that the first cover component (310) moves linearly toward the other end of the syringe needle (110).

5. The sealed diagnostic test box (10) according to claim 4, characterized in that, The first cover component (310) includes a locking button that protrudes through a recess formed in the body (100); The first cover component (310) is locked in rotation, raising and lowering when the locking button is not pressed and is exposed outside the body (100); When the locking button is pressed, the lock is released, thereby performing at least one of rotation, raising and lowering of the first cover component (310).

6. The sealed diagnostic test box (10) according to claim 1, characterized in that, The cover component includes a second cover component (320). The second cover component (320) is configured to switch between the body (100) and the chamber array (200) to expose the opening of the chamber toward the interior of the body (100).

7. The sealed diagnostic test box (10) according to claim 6, characterized in that, When the second cover component (320) is open, the syringe needle (110) is brought close to the chamber; when the second cover component (320) is closed, the chamber is blocked from approaching the syringe needle (110).

8. The sealed diagnostic test box (10) according to claim 6, characterized in that, The opening and closing of the second cover component (320) is determined by the direction in which the chamber array (200) slides relative to a specified position.

9. The sealed diagnostic test box (10) according to claim 8, characterized in that, In the second cover component (320), an elongated groove (322) is formed in an oblique direction with respect to the sliding direction. The protruding protrusion formed in the chamber array (200) is inserted into the elongated slot (322) formed in the second cover member (320), which moves in the oblique direction corresponding to the moving direction of the protruding protrusion.

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