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CN-115386486-B - Card box and detection device

CN115386486BCN 115386486 BCN115386486 BCN 115386486BCN-115386486-B

Abstract

The invention relates to the technical field of biomedical science, and discloses a cartridge and a detection device, wherein the cartridge comprises a cartridge body, a reagent pack group and a sealing cover; the reagent kit comprises a kit body, a reagent pack group, a reagent pump and an air pump, wherein the kit body is provided with a main flow passage, a valve group, a reaction cavity and an air flow passage, the reagent pack group is attached to the surface of the kit body and comprises at least four reagent pack units which are sealed independently, the air flow passage at least comprises a first air flow passage, a second air flow passage, a third air flow passage and a fourth air flow passage which are respectively corresponding to the four reagent pack units, test solution in the reagent pack unit flows into the corresponding air flow passages after breaking bags, and flows into one or more of the reaction cavities along the main flow passages under the control of the valve group and the air pump. The invention can realize the automatic treatment of nucleic acid extraction, amplification and detection, only needs a small number of manual operation steps, and has the advantages of simple operation, safety, convenience, strong tightness and more accurate detection result.

Inventors

  • MEI ZHE
  • Jia Chuhao
  • ZHANG TONG

Assignees

  • 广州万孚生物技术股份有限公司

Dates

Publication Date
20260512
Application Date
20210521

Claims (15)

  1. 1. A cartridge, characterized in that it is intended to be inserted vertically into a mating instrument, comprising a cartridge body (1), a reagent pack group (2) and a cover (3); The cartridge body (1) is provided with a main flow channel, a valve group, a reaction cavity and an air flow channel, wherein the valve group comprises a plurality of valves arranged at preset positions of the main flow channel so that one end of the reaction cavity and one end of the air flow channel are selectively communicated with the main flow channel, and the other end of the air flow channel is provided with an air vent for connecting an air pump; The reaction cavity comprises a sample cavity, a magnetic bead storage cavity (104), a magnetic bead capturing cavity (106), a waste liquid cavity (105), a mixing cavity (107) and a PCR cavity (109), wherein the sample cavity is respectively communicated with the magnetic bead storage cavity (104) and the first end of the magnetic bead capturing cavity (106), the first end of the magnetic bead capturing cavity (106) is also communicated with the mixing cavity (107), the second end opposite to the first end of the magnetic bead capturing cavity is communicated with the waste liquid cavity (105), the mixing cavity (107) is communicated with the PCR cavity (109), the sample cavity is provided with a sample adding port (111), and the sealing cover (3) is used for sealing the sample adding port (111); The reagent pack group (2) is attached to the surface of the card box body (1), and the reagent pack group (2) comprises at least four independently sealed reagent pack units; The reagent pack unit is characterized in that the reagent pack unit comprises a first air flow passage (A1), a second air flow passage (A2), a third air flow passage (A3) and a fourth air flow passage (A4) which are respectively corresponding to the four reagent pack units, wherein after the reagent pack unit is broken, built-in test liquid correspondingly flows into the first air flow passage (A1), the second air flow passage (A2), the third air flow passage (A3) and the fourth air flow passage (A4) and flows into one or more reaction chambers along the main flow passage under the control of the valve group and the air pump; The PCR cavity (109) comprises a central cavity (161), an amplification cavity (162), a zone flow channel (163), a central flow channel groove (164), rong Qiou (165), a waterproof and breathable film (166) and a zone air channel (167); the central flow channel groove (164) is arranged on the front surface of the central cavity (161), the main flow channel is arranged on the back surface of the central cavity (161), the main flow channel is communicated with one end of the central flow channel groove (164), the other end of the central flow channel groove (164) is communicated with the amplification cavity (162) through the area flow channel (163), the waterproof and breathable membrane (166) is attached to the central cavity (161) to seal the central flow channel groove (164), one end of the area air channel (167) is arranged at the edge of a sealing area of the waterproof and breathable membrane (166), and the other end of the area air channel is communicated with the Rong Qiou (165); Two area flow channels are correspondingly arranged in one amplification cavity, and the two area flow channels are respectively an inlet area flow channel and an outlet area flow channel; one end of the inlet area flow channel is communicated with the central flow channel groove, and the other end of the inlet area flow channel is communicated with one end of the amplification cavity; The first barrier is arranged on the inlet area flow channel, and the second barrier is arranged on the outlet area flow channel; The valve comprises a valve cavity (151), an elastic pad (152) and at least one convex part (153); the valve comprises a valve cavity (151), wherein a first flow passage hole (154) is formed in the side face of the valve cavity (151), a second flow passage hole (155) is formed in the bottom of the valve cavity, the elastic pad (152) is located above the second flow passage hole (155), the protruding portion (153) is arranged on the surface of the elastic pad (152) facing the valve cavity (151), and/or a gap is formed between the elastic pad (152) and the second flow passage hole (155) at a position corresponding to the elastic pad (152) on the surface of the valve cavity (151).
  2. 2. The cartridge of claim 1, wherein the four reagent pack units are a lysate pack (121), a binding solution pack (122), a first cleaning solution pack (123) and an eluent pack (124) corresponding to the first air flow channel (A1), the second air flow channel (A2), the third air flow channel (A3) and the fourth air flow channel (A4), respectively; The first air flow channel (A1) is communicated with the magnetic bead storage cavity (104), the second air flow channel (A2) is communicated with the sample cavity, the third air flow channel (A3) is communicated with the first end of the sample cavity or the magnetic bead capturing cavity (106), and the fourth air flow channel (A4) is communicated with the second end of the magnetic bead capturing cavity (106).
  3. 3. The cartridge of claim 2, wherein the reagent pack (2) further comprises a second cleaning liquid pack (125), the air flow channel further comprises a fifth air flow channel (A5) corresponding to the second cleaning liquid pack (125), the fifth air flow channel (A5) being in communication with the first end of the sample chamber or the magnetic bead capture chamber (106).
  4. 4. The cartridge according to claim 1, wherein a sixth air passage (A6), a seventh air passage (A7) and an eighth air passage (A8) are further arranged on the cartridge body (1), one ends of the sixth air passage (A6), the seventh air passage (A7) and the eighth air passage (A8) are respectively provided with the air vent and connected with the air pump, the other end of the sixth air passage (A6) is communicated with the top of the sample cavity, the other end of the seventh air passage (A7) is communicated with the mixing cavity (107), and the other end of the eighth air passage (A8) is communicated with the waste liquid cavity (105).
  5. 5. The cartridge of claim 1, wherein the sample chamber comprises a sample adding chamber (101), an internal freeze-dried bead chamber (102) and a sample processing chamber (103), the sample adding chamber (101) and the sample processing chamber (103) are communicated through a siphon elbow (110), one end of the internal freeze-dried bead chamber (102) is communicated with the bottom of the sample adding chamber (101) and the other end thereof is communicated with one end of the siphon elbow (110), the other end of the siphon elbow (110) is communicated with the top of the sample processing chamber (103), and the sample adding port (111) is arranged at the top of the sample adding chamber (101).
  6. 6. The cartridge according to claim 1, wherein the reaction chamber further comprises a blocking chamber (108), the blocking chamber (108) accessing the main flow path between the mixing chamber (107) and the PCR chamber (109) to block communication between the mixing chamber (107) and the PCR chamber (109) when a preset condition is met.
  7. 7. The cartridge according to claim 1, wherein the cartridge body (1) comprises a cartridge plate (11), a front film (12) and a rear film (13), wherein a cavity or a through hole is formed in the front surface of the cartridge plate (11), the front film (12) is attached to the front surface of the cartridge plate (11), and the rear film (13) is attached to the rear surface of the cartridge plate (11) to seal the cavity or the through hole, thereby forming the reaction chamber.
  8. 8. The cartridge according to claim 7, wherein the main flow passage is composed of at least one front and back groove structure including a front groove (N1), a back groove (N2) and a communication hole (N3), the front groove (N1) is provided on the front surface of the cartridge plate (11), the back groove (N2) is provided on the back surface of the cartridge plate (11), the communication hole (N3) communicates the front groove (N1) and the back groove (N2), and the front film (12) and the back film (13) seal the front groove (N1), the back groove (N2) and the communication hole (N3) to form the main flow passage.
  9. 9. The cartridge of claim 1, wherein the second flow passage hole (155) is provided at the center of the valve chamber (151), the protrusion (153) is provided with one, and the protrusion (153) is provided on the surface of the valve chamber (151) and on the line connecting the first flow passage hole (154) and the second flow passage hole (155).
  10. 10. The cartridge according to claim 9, wherein the first flow passage holes (154) are provided at upper side portions of the valve chamber (151), and corresponding lower portions are inclined downward from outside to inside.
  11. 11. The cartridge of claim 1, wherein the kit comprises a housing (21), a sealing membrane (22) and an attachment (23); The reagent kit comprises a shell (21), a sealing film (22) and a reagent pack unit, wherein the shell (21) is provided with at least four liquid containing cavities with openings facing the front, corresponding test liquid is preset in the liquid containing cavities, the sealing film (22) is adhered to the front of the shell (21) to seal the liquid containing cavities, the reagent pack unit is formed correspondingly, one surface of an attaching part (23) is used for connecting the front of the shell (21), the other surface of the attaching part is used for connecting the surface of a cartridge board (11), and a hollow part is formed at the position, corresponding to the liquid containing cavities, of the attaching part (23).
  12. 12. The cartridge of claim 11, wherein the first air flow channel (A1), the second air flow channel (A2), the third air flow channel (A3) and the fourth air flow channel (A4) each comprise an upper air channel (131), a test solution cavity (132) and a lower flow channel (133), one end of the upper air channel (131) is provided with the air vent, the other end of the upper air channel is communicated with the upper part of the test solution cavity (132), one end of the lower flow channel (133) is communicated with the lower part of the test solution cavity (132), the other end of the lower flow channel is connected with the main flow channel, the test solution cavity (132) corresponds to the containing solution cavity, and after the reagent pack unit is broken, the built-in test solution flows into the test solution cavity (132) and the lower flow channel (133) in sequence.
  13. 13. The cartridge of claim 12, further comprising a breaking member (4), wherein the breaking member (4) is a thermoplastic elastomer; The edge of test solution chamber (132) is equipped with injection molding groove (134), the middle part department of test solution chamber (132) is equipped with separate strip (135) with test solution chamber (132) separate into upper chamber and the lower chamber of mutual intercommunication, separate strip (135) be equipped with on the surface with separate injection molding groove (136) of injection molding groove (134) intercommunication, and all injection molding groove (134) of test solution chamber (132) and separate injection molding groove (136) communicate each other and form one and mould plastics the runner, thermoplastic elastomer is in the runner of moulding plastics the shaping of thermoplastic elastomer.
  14. 14. The cartridge according to claim 1, wherein the cover (3) comprises a template (31) and a plug (32); the sample adding plate (31) is provided with a sample adding port (111) and a first fixing part (311), and the sample adding plate (31) is arranged at the top of the sample cavity; the plug cover (32) comprises a base plate (321), a plunger (322) and a second fixing part (323), wherein one end of the plunger (322) is arranged on the bottom surface of the base plate (321), and the other end of the plunger is used for being inserted into the sample adding port (111) to seal the sample adding port (111); One end of the second fixing part (323) is connected with the side surface of the base plate (321) through a bendable piece (324), and the other end of the second fixing part is connected with the first fixing part (311).
  15. 15. A test device comprising a cartridge according to any one of claims 1 to 14 and a kit comprising an air pump in communication with each vent, the kit being provided with a slot for vertically inserting the cartridge into the kit.

Description

Card box and detection device Technical Field The invention relates to the technical field of biomedical treatment, in particular to a card box and a detection device. Background Nucleic acid detection has a very important role in many biochemical analysis fields, and has been widely used in biomedical fields. The prior art generally uses a centrifugal column method or a magnetic bead method for nucleic acid extraction, and generally requires four steps of cleavage, binding, washing and elution. After extracting the nucleic acid from the sample, the subsequent steps of nucleic acid molecular hybridization, polymerase Chain Reaction (PCR), biochip and the like are continued to finish the nucleic acid detection. The number of nucleic acid detection steps makes the whole full-automatic detection equipment from sample to result very difficult to realize. In addition, as for the transfer of the effective components in each step, a manual transfer mode is mostly adopted in the prior art, so that the operation is complex, time and labor are wasted, materials are difficult to sufficiently and efficiently transfer, the result is unstable easily caused by manual operation, and the detection implementation difficulty is high. In addition, the main flow technology of molecular detection is a fluorescent quantitative PCR technology, and the existing open consumable material causes the pollution of PCR aerosol easily in the whole operation process and influences the purity of the extract due to the characteristic of exponential amplification templates in the PCR technology, so that the fluorescent quantitative PCR technology is limited to be further applied to clinic. Thus, improvements are needed in the art. Disclosure of Invention The invention aims to provide a cartridge and a detection device, which are used for solving the technical problems that the full-automatic treatment of nucleic acid detection is difficult to realize, and the detection result is unstable, the detection accuracy is low and the detection efficiency is low due to manual operation and the use of open consumables in the prior art. In order to achieve the above object, the present invention provides a cartridge comprising a cartridge body, a reagent pack group and a cover; the cartridge body is provided with a main flow channel, a valve group, a reaction cavity and an air flow channel, wherein the valve group comprises a plurality of valves arranged at preset positions of the main flow channel, so that one end of the reaction cavity and one end of the air flow channel are selectively communicated with the main flow channel, and the other end of the air flow channel is provided with an air vent for connecting an air pump; the reaction cavity comprises a sample cavity, a magnetic bead storage cavity, a magnetic bead capturing cavity, a waste liquid cavity, a mixing cavity and a PCR cavity; the sample cavity is respectively communicated with the magnetic bead storage cavity and the first end of the magnetic bead capturing cavity, the first end of the magnetic bead capturing cavity is also communicated with the mixing cavity, and the second end of the magnetic bead capturing cavity is opposite to the mixing cavity and communicated with the waste liquid cavity; The reagent pack group is attached to the surface of the card box body and comprises at least four reagent pack units which are sealed independently; The reagent pack unit is characterized in that the air flow channels at least comprise a first air flow channel, a second air flow channel, a third air flow channel and a fourth air flow channel which are respectively corresponding to the four reagent pack units, and after the reagent pack unit is broken, the built-in test solution of the reagent pack unit correspondingly flows into the first air flow channel, the second air flow channel, the third air flow channel and the fourth air flow channel and flows into one or more reaction cavities along the main flow channel under the control of the valve group and the air pump. In some embodiments of the present application, the four reagent pack units are a lysate pack, a binding solution pack, a first cleaning solution pack, and an eluent pack corresponding to the first air flow channel, the second air flow channel, the third air flow channel, and the fourth air flow channel, respectively; The first air flow channel is communicated with the magnetic bead storage cavity, the second air flow channel is communicated with the sample cavity, the third air flow channel is communicated with the first end of the sample cavity or the magnetic bead capturing cavity, and the fourth air flow channel is communicated with the second end of the magnetic bead capturing cavity. In some embodiments of the present application, the four reagent pack units are a lysate pack, a binding solution pack, a first cleaning solution pack, and an eluent pack corresponding to the first air flow channel, the second air flow channel, t