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CN-121991790-A - Integrated sample processing and nucleic acid amplification detection device and method

CN121991790ACN 121991790 ACN121991790 ACN 121991790ACN-121991790-A

Abstract

The invention discloses an integrated sample processing and nucleic acid amplification detection device and method, belonging to the technical field of molecular diagnosis and biological detection, comprising a syringe component, a mixing chamber component and a reaction chamber component, the injection tube assembly, the mixing chamber assembly and the reaction chamber assembly are sequentially and detachably arranged together, and a puncture needle with a downward tip is arranged in the injection tube assembly. The invention has the advantages of simplified operation, reduced technical requirements for users, reduced pollution risk, improved reliability of detection results, reduced result fluctuation caused by manual operation difference, integrated design, compact volume, convenient carrying, storage and distribution as single consumable, suitability for application scenes with high requirements on convenience such as basic level clinics, on-site rapid detection, home self-detection and the like, and promotion of popularization of molecular detection technology.

Inventors

  • WU HESEN
  • GUO XUEMIN
  • Zeng Langming
  • Weng Ruiqiang

Assignees

  • 梅州市人民医院(梅州市医学科学院)

Dates

Publication Date
20260508
Application Date
20260226

Claims (10)

  1. 1. The integrated sample processing and nucleic acid amplification detection device is characterized by comprising a syringe assembly (1), a mixing chamber assembly (4) and a reaction chamber assembly (5), wherein the syringe assembly (1), the mixing chamber assembly (4) and the reaction chamber assembly (5) are sequentially and detachably installed together, and a puncture needle (2) with a downward tip is arranged in the syringe assembly (1).
  2. 2. The integrated sample processing and nucleic acid amplification detection device according to claim 1, wherein the syringe assembly (1) comprises a syringe body (101), a piston (102) is slidably arranged in the syringe body (101), a piston rod (103) is arranged on the top surface of the piston (102), and the lancet (2) is arranged in the center of the bottom surface of the piston (102).
  3. 3. The integrated sample processing and nucleic acid amplification detection device according to claim 2, wherein a lancet reset fixture block (10101) and a lancet limit fixture block (10102) are arranged on the inner wall of the syringe body (101), a first limit boss (10103) is arranged on the outer wall of the syringe body (101), and a fifth connection port (10104) is arranged below the first limit boss (10103).
  4. 4. The integrated sample processing and nucleic acid amplification detection apparatus as set forth in claim 2, wherein the piston rod (103) is provided with a plurality of first limit blocks (10301).
  5. 5. The integrated sample processing and nucleic acid amplification detection device according to claim 4, wherein a positioning piece (3) is detachably arranged on the syringe body (101), a through hole (301) through which the top end of the piston rod (103) can pass is formed in the top surface of the positioning piece (3), and a first limiting clamping groove (302) matched with the first limiting clamping block (10301) is formed in the positioning piece (3).
  6. 6. The integrated sample processing and nucleic acid amplification detection device as set forth in claim 3, wherein the mixing chamber assembly (4) comprises a mixing cylinder (401) and a sample adding tube (402), the sample adding tube (402) is detachably connected below the mixing cylinder (401), and a sealing film (403) is disposed on the top of the sample adding tube (402).
  7. 7. The integrated sample processing and nucleic acid amplification detection device according to claim 6, wherein a second connection port (40103) and a third connection port (40104) are respectively arranged at the upper end and the lower end of the mixing cylinder (401), and a second limit clamping block (40101) and a second limit clamping groove (40102) are arranged on the outer wall of the mixing cylinder (401), and the second connection port (40103) is in threaded connection with the fifth connection port (10104); the top of sampling tube (402) be provided with fourth connector (40201) of third connector (40104) assorted, the bottom of fourth connector (40201) is provided with application of sample needle (40202), the top of application of sample needle (40202) is provided with seal membrane (403).
  8. 8. The integrated sample processing and nucleic acid amplification detection device as set forth in claim 7, wherein the reaction chamber assembly (5) comprises a reaction cylinder (501), a third limit clamping block (50101) matched with the second limit clamping groove (40102) is arranged on the inner wall of the reaction cylinder (501), a PCR reaction tube (502) is arranged in the reaction cylinder (501), and a soft rubber plug (503) is arranged on the top surface of the PCR reaction tube (502).
  9. 9. The integrated sample processing and nucleic acid amplification detection apparatus as set forth in claim 8, wherein a base (504) is detachably provided at a bottom of the reaction cylinder (501).
  10. 10. A sample processing and nucleic acid amplification detection method using the integrated sample processing and nucleic acid amplification detection apparatus according to any one of claims 1 to 9, characterized by comprising the steps of: Step one, a cracking liquid is pre-stored in a mixing cylinder (401), an amplification reaction liquid is pre-stored in a PCR reaction tube (502), and a syringe assembly (1), a mixing chamber assembly (4) and a reaction chamber assembly (5) are sequentially installed and connected; separating the injection cylinder assembly (1) from the mixing chamber assembly (4), adding a sample to be tested into the mixing cylinder (401), and then reinstalling the injection cylinder assembly (1); Step three, mixing a sample and a lysis solution in a mixing cylinder (401) to form a sample lysis mixed solution; Step four, taking down the positioning piece (3), pressing down the piston rod (103), driving the piston (102) and the puncture needle (2) to move downwards, and puncturing the sealing film (403) by using the puncture needle (2); step five, moving the puncture needle (2) upwards to enable the sample cracking mixed solution to flow into the PCR reaction tube (502) through the sample adding needle (40202) and mix with the amplification reaction solution in the sample cracking mixed solution; and step six, performing nucleic acid amplification detection on the mixed solution in the PCR reaction tube (502).

Description

Integrated sample processing and nucleic acid amplification detection device and method Technical Field The invention relates to the technical field of molecular diagnosis and biological detection, in particular to an integrated sample processing and nucleic acid amplification detection device and method. Background Currently, nucleic acid detection techniques represented by Polymerase Chain Reaction (PCR) have been widely used in the fields of disease diagnosis, pathogen screening, and the like. Standard nucleic acid detection procedures typically include sample lysis, nucleic acid extraction and purification, eluent transfer, reaction system construction (which may involve dilution), and final amplification and detection. These steps typically rely on multiple separate consumables such as lysis tubes, purification columns/beads, dilution tubes, and PCR reaction tubes. The technical scheme has the main problems that firstly, the operation flow is complex, operators are required to frequently open different pipe covers and transfer liquid for multiple times, the requirement on operation skills is high, and mistakes are easy to occur. Second, the uncapping and pipetting steps increase the risk of aerosol and sample cross-contamination, which can affect the accuracy and reliability of the test results. Again, the multiple discrete consumables increase operational complexity, storage space usage, and logistics costs. Finally, this complexity limits the popularity and application of the technology in the context of basic medical points, sites or households, etc. where convenience and rapidity are sought. Disclosure of Invention The invention aims to provide an integrated sample processing and nucleic acid amplification detection device and method, which solve the problems of complex operation, high technical requirements, high pollution risk, low integration level and poor portability of the traditional device. In order to solve the technical problems, the invention adopts the following technical scheme: the invention relates to an integrated sample processing and nucleic acid amplification detection device which comprises a syringe assembly, a mixing chamber assembly and a reaction chamber assembly, wherein the syringe assembly, the mixing chamber assembly and the reaction chamber assembly are sequentially and detachably arranged together, and a puncture needle with a downward tip is arranged in the syringe assembly. Further, the injection cylinder assembly comprises an injection cylinder body, a piston is slidably arranged in the injection cylinder body, a piston rod is arranged on the top surface of the piston, and the puncture needle is arranged in the center of the bottom surface of the piston. Still further, a puncture needle reset fixture block and a puncture needle limit fixture block are arranged on the inner wall of the injection cylinder body, a first limit boss is arranged on the outer wall of the injection cylinder body, and a fifth connection port is arranged below the first limit boss. Still further, be provided with a plurality of first spacing fixture blocks on the piston rod. Still further, the last detachable setting element that is provided with of syringe body, the top surface of setting element is provided with the confession the through-hole that the piston rod top passed through, be provided with on the setting element with first spacing fixture block assorted first spacing draw-in groove. Still further, the mixing chamber subassembly includes mixing cylinder and adds the pipe, it is in to add the pipe detachable connection mix the below of cylinder to add the top of pipe and be provided with the sealing membrane. Still further, the upper and lower ends of the mixing cylinder are respectively provided with a second connecting port and a third connecting port, and the outer wall of the mixing cylinder is provided with a second limit clamping block and a second limit clamping groove; The top of the sample adding pipe is provided with a fourth connecting port matched with the third connecting port, the bottom of the fourth connecting port is provided with a sample adding needle, and the top of the sample adding needle is provided with a sealing film. Still further, the reaction chamber subassembly includes the reaction barrel, be provided with on the inner wall of reaction barrel with second spacing draw-in groove assorted third spacing fixture block, be provided with the PCR reaction tube in the reaction barrel, the top surface of PCR reaction tube is provided with soft plug. Still further, the bottom of reaction barrel detachable is provided with the base. A method for sample processing and nucleic acid amplification detection using the integrated sample processing and nucleic acid amplification detection device according to any one of the above, comprising the steps of: Step one, a cracking liquid is pre-stored in a mixing cylinder, an amplification reaction liquid is pre-stored in a PCR