Integrated detection kit for disease diagnosis and diagnosis equipment

Abstract

The present invention provides a one-piece kit (100) for on-site diagnosis, and relates to a one-piece kit capable of injecting a sample solution or even performing detection, the kit being characterized by being equipped with a sample injection lid (12), a sample injection port (14), a tip (12), a two-dimensional bar code (15), a sample chamber (22), a buffer chamber (23), a mixing chamber (25), a washing chamber (26), a PCR chamber (28) for performing PCR, etc. The detection kit (100) can be used for molecular diagnosis, and the diagnostic equipment used for the detection kit can be selectively used for molecular diagnosis, immunodiagnosis, rapid diagnosis and the like.

Description

Technical Field

[0001] The present invention relates to a detection kit used in a device for diagnosing diseases using biological substances such as proteins or DNA. The detection kit provided by the present invention is an on-site diagnostic all-in-one detection kit (All-in-one POC catridge) that can quickly diagnose the protein or DNA on-site, and is a detection kit with an integrated structure that can be visually detected after a sample is injected into the detection kit provided by the present invention. Background Art

[0002] Recently, the global spread of respiratory infections such as COVID-19 has become a major issue, and in addition to the above diseases, people's concern for a healthy living environment has also increased, so technology that can quickly diagnose the presence or absence of diseases on site has attracted increasing attention.

[0003] In particular, for molecular diagnostics or immunodiagnostics characterized by the detection of proteins or DNA, given the complexity of automating molecular detection and immunoassay technology, no product has yet provided performance suitable for clinical use in near-patient testing equipment. Typical molecular tests include various processes, such as accurate dosage of reagents, sample introduction, cell lysis to extract DNA or RNA, purification steps, and amplification for subsequent testing. Although there are central laboratory robotic platforms that automate the above processes, for tests that require a shorter time, central laboratories are unable to provide results within the required specified time.

[0004] However, it is difficult to implement systems that can provide accurate and reliable results at a reasonable cost within a clinical setting. Given the complex nature of various molecular testing technologies, diagnostic results can easily be significantly inaccurate if test parameters are not carefully controlled or environmental conditions are suboptimal.

[0005] In particular, for the purpose of detecting proteins or DNA, etc., a method recently used is to extract the above-mentioned biological substance and place it in a biochip made of a material such as glass, silicon, metal, or plastic, and in this state, after undergoing a gene amplification process and irradiating the biochip with a light source, diagnosis is performed by analyzing the amount of light (fluorescence) generated from the biochip. In the above-mentioned diagnostic method, the above-mentioned extracted biological substance is injected into a biochip and loaded into a diagnostic device. This device for extracting a specific biological substance to be diagnosed into a biochip is called a detection box. The specific biological substance is extracted from biological substances in a living body.

[0006] In the past, there were almost no cases where extraction was performed while the detection box as described above was contained in a diagnostic device. Usually, an independent device for preparing a biochip was made, and the biochip prepared in the device was put into a diagnostic device made for diagnostic purposes. However, since the preparation of the biochip and the continuity of the diagnostic process were severed in this method, a lot of time was required for diagnosis, or during the PCR process, the biological substance leaked to the outside of the biochip and contaminated the device, and the diagnostic results often resulted in huge errors. Summary of the invention

[0007] Technical issues

[0008] The present invention is used to solve the problems of previous molecular diagnosis, namely, the various processes of accurate dosage of reagents, sample introduction, cell lysis to extract DNA or RNA, purification steps, and amplification for subsequent detection are time-consuming, and the preparation of the biochip into which the biological material is input is disconnected from the continuity of the diagnosis process. The integrated on-site diagnostic test kit provided by the present invention integrates the tip for loading the directly injected sample into the diagnostic equipment for detection, thereby solving the above-mentioned problems.

[0009] Technical Solution

[0010] The integrated detection box for on-site diagnosis provided by the present invention is formed with the following structure: the outer shape is manufactured into a rectangular parallelepiped shape, a sample injection port is formed on one side of the detection box, and a sample chamber, a buffer chamber, a mixing chamber, a washing chamber and a PCR chamber, etc. are respectively equipped for storing the sample injected from the sample injection port, and an aluminum foil is attached to protect the injected sample. A soft and thin sealing film is assembled on the upper cover and the lower cover, and has a structure that can be moved left and right. The tip assembled on the sealing film can move up and down and left and right on the upper part of the chamber.

[0011] In addition, the detection kit provided by the present invention can perform molecular diagnosis or immunological diagnosis with the help of independent modules according to the object to be detected, without changing the detection kit and the diagnostic equipment inserted into the detection kit for diagnosis.

[0012] Effects of the Invention

[0013] By using the integrated detection kit for on-site diagnosis provided by the present invention, proteins or DNA can be detected to quickly perform the diagnostic process. In addition, the time required for detecting the protein or DNA can be significantly saved, and sample injection and detection can be achieved in an integrated manner, which can improve the reliability of the diagnostic result. In addition, the detection kit provided by the present invention can perform molecular diagnosis or immunodiagnosis in the same diagnostic device with the help of an independent module according to the object to be detected, without changing the detection kit and the diagnostic device into which the detection kit is inserted for diagnosis. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figure 1 The overall shape of the detection box provided by the present invention is shown.

[0015] Figure 2 The various chambers provided inside the detection box provided by the present invention are shown.

[0016] Figure 3a The process of sealing the PCR chamber when performing PCR diagnosis using the detection box provided by the present invention is shown.

[0017] Figure 3b The diagram shows the state in which the sealing of the PCR chamber is completed when the detection box provided by the present invention is used for PCR diagnosis.

[0018] Figure 4 The front side of the diagnostic device loaded with the detection cartridge provided by the present invention is shown.

[0019] Figure 5 The back side of the diagnostic device loaded with the detection cartridge provided by the present invention is shown. DETAILED DESCRIPTION

[0020] The preferred embodiments of the present invention are described in detail below with reference to the accompanying drawings. Prior to this, the terms or words used in this specification and claims shall not be limited to the usual meaning or the meaning in the dictionary for interpretation, but shall be based on the principle that the inventor can appropriately define the concept of terms in order to describe his own invention in the best way, and shall be interpreted as the meaning and concept that conforms to the technical idea of ​​the present invention. Therefore, it should be understood that the embodiments described in this specification and the structures shown in the accompanying drawings are only the most preferred embodiments of the present invention, and do not fully represent the technical idea of ​​the present invention. Therefore, at the time of this application, there may be various equivalents and modifications that can replace them.

[0021] Figure 1 1 is a three-dimensional diagram of the integrated detection box 100 provided by the present invention. Figure 1 As shown, the detection box 100 of the present invention is covered by an upper cover 10 and a lower cover 16, a sample injection cover 12 and a sample injection port 14 are formed on the outside of the detection box 100, a tip 12 for loading the injected sample is provided inside, and a two-dimensional barcode 15 is provided on the bottom surface of the detection box 100.

[0022] A sample solution containing a target protein or DNA is injected into the sample injection port 14 using a pipette or the like. After the sample solution is injected, the sample injection cap 12 is closed to seal the sample solution.

[0023] A code is preset in the two-dimensional barcode 15, and the code is used to identify whether it is a molecular diagnosis mode or an immune diagnosis mode, etc., according to whether the target to be diagnosed by the detection box 100 of the present invention is protein or DNA, etc.

[0024] According to the mode (module) set in the two-dimensional barcode 15, the diagnostic device 300 for diagnosis using the detection box 100 provided by the present invention executes a driving process corresponding to the molecular diagnosis mode or the immune diagnosis mode. According to this setting, the detection box 100 and the diagnostic device 300 provided by the present invention can execute various modules in one device.

[0025] Figure 2 Various components for driving the detection box 100 provided by the present invention are shown.

[0026] according to Figure 2 The lower part 17 of the detection box 100 may be equipped with: a sample chamber 22, which seals the injected sample solution; a buffer chamber 23, which contains a solution for lysis and binding required for molecular diagnosis by loading the sample solution injected by the tip 12; a mixing chamber 25; a washing chamber 26; a buffer chamber 27, which contains a solution for elution; and a PCR chamber 28, which is used to perform PCR. In addition, an extraction and lyophilization chamber 29 for extracting and lyophilizing the target from the sample solution may also be provided.

[0027] In addition, a tip filter 20 is provided at the upper portion of the tip 12 for loading the sample solution, for preventing impurities and the like from entering the sample solution and preventing contamination to the outside.

[0028] Furthermore, in order to prevent the solution from evaporating and moving due to circulation when the test kit 100 provided by the present invention is used for diagnosis, the upper surface of the lower part 17 of the test kit is sealed with an aluminum foil 21 .

[0029] In addition, in order to prevent the sample solution inside the chamber from evaporating to the upper part of the detection box 100 or contaminating the outside when performing molecular diagnosis, it has a structure for allowing the tip 12 to move up and down, and also has a structure that can move left and right, and has a soft and thin sealing film 11 assembled with the upper cover 10 and the lower cover 16.

[0030] like Figure 2 As shown, when the detection box 100 is used to perform molecular diagnosis or immunodiagnosis, the tip 12 moves up and down in the sample chamber 22 with the help of the syringe module and loads the sample solution. In order to move the loaded sample solution to the buffer chamber 23, the mixing chamber 25, the PCR chamber 28, etc., the tip 12 is designed to move left and right with the help of a motor (not shown). The tip 12 moves left and right with the help of a sealing film 11 that divides the upper space of the detection box 100 into upper and lower parts. For this purpose, the tip 12 and the sealing film 11 are assembled into one body to move.

[0031] In addition, the PCR chamber 28 is formed by a thin film-shaped hot melt cavity structure, which is a structure used to increase the heating and cooling speed (heating and cooling) of the thermal amplification cycle process of PCR. By using the detection box 100 of the present invention, the PCR amplification speed can be increased, thereby increasing the diagnosis speed.

[0032] The PCR chamber 28 may be formed of a 4-chamber structure, and in this case, by using 4 chambers and 4 fluorescent dyes, 16 types of fluorescence can be realized.

[0033] FIG. 3 shows a sealing process for preventing the detection box 100 from being contaminated by thermal amplification of PCR, etc. when molecular diagnosis is performed through a PCR process using the detection box 100 provided by the present invention.

[0034] Figure 3a The state in which the sample solution is loaded into the tip 12 and the sample solution is loaded into the PCR chamber 28 after the sample solution is injected and the sample pretreatment is performed, and the previous step of sealing the lower part 17 of the detection box by the upper cover 10 and the lower cover 16 is shown. Figure 3b The figure shows that after the sample solution is loaded into the PCR chamber 28, during the PCR amplification process, in order to prevent the sample solution from evaporating or being contaminated, the upper cover 10 and the lower cover 16 are moved left and right while the lower part 17 of the detection box is fixed, so as to seal the injection port of each PCR chamber 28 and perfectly seal the detection box 100.

[0035] In addition, the detection box 100 provided by the present invention can perform molecular diagnosis, immunodiagnosis and rapid diagnosis (rapid kit) according to the biological substance that becomes the detection object, and each diagnostic process can be executed differently according to the code set in the two-dimensional barcode 15 equipped on the bottom surface of the detection box 100.

[0036] Figure 4 and Figure 5 The diagnostic device 300 is shown to be loaded with the detection cartridge 100 provided by the present invention to perform the molecular diagnosis, immunodiagnosis, rapid diagnosis, etc.

[0037] according to Figure 4 The diagnostic device 300 includes a detection box loading unit 39 for loading the detection box 100, a detection box heating unit 38 for heating the detection box, a magnetic separation unit 37 for separating the sample solution, a multiple detection unit 36 ​​for molecular diagnosis, a detection unit 35 for immunodiagnosis, a syringe unit 34 for quantitatively inhaling and discharging a solution, a tip unit 33 for driving the syringe unit 34 up and down, a pipe and a fan 32 for thermal circulation, and a main circuit unit 31 for executing the process.

[0038] When the detection box 100 provided by the present invention is used to perform a diagnostic process, codes representing molecular diagnosis, immune diagnosis, rapid diagnosis, etc. are preset in the two-dimensional barcode 15 of the detection box 100. When the detection box 100 is loaded on the diagnostic device 300, the diagnostic device 300 automatically recognizes the code set in the two-dimensional barcode 15 to perform molecular diagnosis, immune diagnosis, rapid diagnosis, etc. respectively.

[0039] <Reference Numbers>

[0040] 100: Detection box

[0041] 10: Upper cover 11: Sealing film

[0042] 12: Tip 13: Sample injection cap

[0043] 14: Sample injection port 15: 2D barcode

[0044] 16: Lower cover 17 detection box lower part

[0045] 20: Tip filter 21: Aluminum foil

[0046] 22: Sample chamber 23: Buffer chamber (lysis, binding)

[0047] 24: Tip chamber 25: Mixing chamber

[0048] 26: Washing chamber 27: Buffer chamber (elution)

[0049] 28: PCR room 29: Extraction and freeze-drying room

[0050] 300: Diagnostic equipment

[0051] 31: Main circuit 32: Pipes and fans for heat circulation

[0052] 33: Tip 34: Syringe

[0053] 35: Immunodiagnosis and Testing Department 36: Molecular Diagnosis and Testing Department

[0054] 37: Magnetic separation unit 38: Detection box heating unit

[0055] 39: Detection box loading unit

[0056] The invention of this case is described based on the above-mentioned drawings. However, ordinary technicians should understand that the technical concept of the invention of this case is not limited by the above-mentioned drawings, but can be extended to all structures that include the technical features of the invention of this case.

[0057] Industrial Applicability

[0058] The present invention can be applied industrially.

Claims

1. An integrated detection box (100), characterized in that: The detection box (100) is covered by an upper cover (10) and a lower cover (16); a sample injection cover (12) and a sample injection port (14) are formed on the outside of the detection box (100); a tip (12) for loading an injected sample solution is provided inside the detection box (100); a two-dimensional barcode (15) is provided on the bottom surface of the detection box (100); the following components are provided at the bottom of the detection box (100) and are sealed by an aluminum foil (21): a sample chamber (22) for sealing the injected sample solution; a buffer chamber (23) for containing a solution for lysis and binding required for performing diagnosis by loading the injected sample solution with the help of the tip (12); a mixing chamber (25); a washing chamber (26); a buffer chamber (27) for containing a solution for elution; and a PCR chamber (28) for performing PCR.

2. The integrated detection box (100) according to claim 1, characterized in that: An extraction and freeze-drying chamber (29) is also provided at the lower part of the detection box (100), which is used to extract the target from the sample solution and freeze-dry it.

3. The integrated detection box (100) according to claim 1, characterized in that: A tip filter (20) is also provided on the upper portion of the tip (12) to prevent impurities from entering the sample solution.

4. The integrated detection box (100) according to claim 1, characterized in that: The PCR chamber (28) of the detection box is formed with a hot-melt cavity structure.

5. The integrated detection box (100) according to claim 4, characterized in that: The PCR chamber (28) is formed by four heat-melting cavity structures.

6. The integrated detection box (100) according to claim 1, characterized in that: It also includes a sealing film (11) for dividing the upper space of the detection box (100) into upper and lower parts. The tip (12) and the sealing film (11) are assembled into one body. When the detection box (100) is sealed, the tip (12) can move left and right, and the tip (12) can move up and down.

7. The integrated detection box (100) according to claim 1, characterized in that: When the detection box (100) is used to perform diagnosis through the PCR process, in order to prevent the detection box (100) from being contaminated by the thermal amplification of PCR, the lower part of the detection box (100), that is, the lower part (17) of the detection box is fixed, and the upper cover (10) and the lower cover (16) are movable left and right to seal the upper part of the PCR chamber (28).

8. The integrated detection box (100) according to any one of claims 1 to 7, characterized in that: It is used to perform any diagnostic process among molecular diagnosis, immune diagnosis or rapid diagnosis through the two-dimensional barcode (15) equipped with the detection box (100).

9. A diagnostic device (300), characterized in that A detection unit (35, 36) capable of performing diagnosis is provided in a manner that the integrated detection box (100) described in any one of claims 1 to 7 can be loaded to perform diagnosis.

10. The diagnostic device (300) according to claim 9, characterized in that The diagnostic device (300) performs any one of molecular diagnosis, immune diagnosis or rapid diagnosis through the two-dimensional barcode (15) equipped with the detection box (100).

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