A cartridge and detection device

Abstract

The application relates to the field of biological medical technology and discloses a card box and a detection device, wherein the card box comprises a card box body, a reagent bag group and a cover; the card box body is provided with a main flow channel, a valve group, a reaction cavity and an airflow channel; the reagent bag group is attached to the surface of the card box body and comprises at least four independently sealed reagent bag units; the airflow channel comprises at least a first airflow channel, a second airflow channel, a third airflow channel and a fourth airflow channel corresponding to the four reagent bag units respectively; after the reagent solution in the reagent bag units is broken, the reagent solution flows into the corresponding airflow channel and flows into one or more of the reaction cavities along the main flow channel under the control of the valve group and an air pump. The application can realize the automatic processing of nucleic acid extraction, amplification and detection, only needs a small number of manual operation steps, is simple to operate, safe and convenient, has high sealing performance and is more accurate in detection results.

Description

Technical Field

[0001] This invention relates to the field of biomedical technology, and in particular to a card holder and a detection device. Background Technology

[0002] Nucleic acid testing plays a vital role in many fields of biochemical analysis and has been widely applied in the biomedical field.

[0003] Current technologies typically use centrifugation column methods or magnetic bead methods for nucleic acid extraction, generally requiring four steps: lysis, binding, washing, and elution. After nucleic acid extraction, subsequent steps such as nucleic acid hybridization, polymerase chain reaction (PCR), and bioarrays are performed to complete nucleic acid detection.

[0004] Because nucleic acid testing involves many steps, it is extremely difficult to achieve fully automated testing equipment "from sample to result". Furthermore, in terms of the transfer of effective components in each step, existing technologies mostly use manual transfer methods, which are not only cumbersome, time-consuming and labor-intensive, but also difficult to transfer materials fully and efficiently. Manual operation is prone to causing unstable results, making the testing difficult to implement.

[0005] In addition, the mainstream technology for molecular detection is quantitative real-time PCR. Due to the exponential amplification of templates by PCR technology, the existing open consumables make the entire operation process prone to PCR aerosol contamination, affecting the purity of the extract, thus limiting the further clinical application of quantitative real-time PCR technology.

[0006] Therefore, existing technologies urgently need improvement. Summary of the Invention

[0007] The purpose of this invention is to provide a cartridge and a detection device to solve the technical problems of difficulty in achieving fully automated processing of nucleic acid detection in the prior art, as well as the instability of detection results, low detection accuracy and low detection efficiency caused by manual operation and the use of open consumables.

[0008] To achieve the above objectives, the present invention provides a cartridge, comprising a cartridge body, a reagent pack assembly, and a cap;

[0009] The cartridge body is provided with a main channel, a valve group, a reaction chamber and an airflow channel; the valve group includes a number of valves located at predetermined positions in the main channel, so that one end of the reaction chamber and one end of the airflow channel can be selectively connected to the main channel, and the other end of the airflow channel has a vent for connecting an air pump;

[0010] The reaction chamber includes a sample chamber, a magnetic bead storage chamber, a magnetic bead capture chamber, a waste liquid chamber, a mixing chamber, and a PCR chamber; the sample chamber is connected to the first ends of the magnetic bead storage chamber and the magnetic bead capture chamber respectively; the first end of the magnetic bead capture chamber is also connected to the mixing chamber, and its opposite second end is connected to the waste liquid chamber; the mixing chamber is connected to the PCR chamber; the sample chamber has a sample dispensing port, and the cap is used to seal the sample dispensing port;

[0011] The reagent pack assembly is affixed to the surface of the card box body, and the reagent pack assembly includes at least four independently sealed reagent pack units;

[0012] The airflow channels include at least a first airflow channel, a second airflow channel, a third airflow channel, and a fourth airflow channel, which correspond to the four reagent pack units respectively. After the reagent pack unit is broken, the test liquid inside flows into the first airflow channel, the second airflow channel, the third airflow channel, and the fourth airflow channel respectively, and flows into one or more of the reaction chambers along the main flow channel under the control of the valve group and the air pump.

[0013] In some embodiments of this application, the four reagent pack units are respectively a lysis buffer pack, a binding buffer pack, a first washing buffer pack, and an elution buffer pack corresponding to the first gas flow channel, the second gas flow channel, the third gas flow channel, and the fourth gas flow channel;

[0014] The first airflow channel is connected to the magnetic bead storage cavity, the second airflow channel is connected to the sample cavity, the third airflow channel is connected to the first end of the sample cavity or the magnetic bead capturing cavity, and the fourth airflow channel is connected to the second end of the magnetic bead capturing cavity.

[0015] In some embodiments of this application, the four reagent pack units are respectively a lysis buffer pack, a binding buffer pack, a first washing buffer pack, and an elution buffer pack corresponding to the first gas flow channel, the second gas flow channel, the third gas flow channel, and the fourth gas flow channel;

[0016] The first airflow channel is connected to the sample cavity, the second airflow channel is connected to the magnetic bead storage cavity, the third airflow channel is connected to the first end of the sample cavity or the magnetic bead capturing cavity, and the fourth airflow channel is connected to the second end of the magnetic bead capturing cavity.

[0017] In some embodiments of this application, the reagent pack group further includes a second cleaning solution pack, and the gas channel further includes a fifth gas flow channel corresponding to the second cleaning solution pack, the fifth gas flow channel being connected to the first end of the sample chamber or the magnetic bead capture chamber.

[0018] In some embodiments of this application, the card box body is further provided with a sixth air channel, a seventh air channel and an eighth air channel; one end of each of the sixth, seventh and eighth air channels has an air inlet connected to the air pump, the other end of the sixth air channel is connected to the top of the sample chamber, the other end of the seventh air channel is connected to the mixing chamber, and the other end of the eighth air channel is connected to the waste liquid chamber.

[0019] In some embodiments of this application, the sample cavity includes a sample inlet cavity and a sample processing cavity, and the sample inlet cavity and the sample processing cavity are connected by a siphon bend; one end of the siphon bend is connected to the bottom of the sample inlet cavity, and the other end is connected to the top of the sample processing cavity; the sample inlet is located at the top of the sample inlet cavity.

[0020] In some embodiments of this application, an internal reference freeze-dried bead chamber is further provided between the siphon bend and the sample addition chamber; one end of the internal reference freeze-dried bead chamber is connected to the bottom of the sample addition chamber, and the other end of the internal reference freeze-dried bead chamber is connected to the siphon bend.

[0021] In some embodiments of this application, a blocking cavity is further included; the blocking cavity is connected to the main channel between the mixing cavity and the PCR cavity, so as to block the communication between the mixing cavity and the PCR cavity when a preset condition is met.

[0022] In some embodiments of this application, the blocking cavity is a wax valve cavity, which is pre-filled with solid wax.

[0023] In some embodiments of this application, the card box body includes a card box plate, a front film, and a rear film; the front of the card box plate is provided with a cavity or a through hole, the front film is attached to the front of the card box plate, and the rear film is attached to the back of the card box plate to seal the cavity or the through hole, thereby forming the reaction chamber.

[0024] In some embodiments of this application, the main channel is composed of at least one positive and negative groove structure; the positive and negative groove structure includes a positive groove, a back groove, and a connecting hole; the positive groove is disposed on the front side of the card holder plate, the back groove is disposed on the back side of the card holder plate, and the connecting hole connects the positive groove and the back groove; the front film and the rear film seal the positive groove, the back groove, and the connecting hole to form the main channel.

[0025] In some embodiments of this application, the PCR chamber includes a central chamber, an amplification chamber, and a flow channel;

[0026] The central cavity is connected to the flow channel; at least one amplification cavity is provided, and the amplification cavity is connected to the central cavity through the flow channel.

[0027] In some embodiments of this application, the PCR cavity further includes a central flow channel, a gas-containing area, a waterproof and breathable membrane, and a zone air channel;

[0028] The central flow channel groove is disposed on one surface of the central cavity, and the flow channel is disposed on the opposite surface of the central cavity. One end of the flow channel is connected to the central flow channel groove, and the other end of the central flow channel groove is connected to the zone flow channel. The waterproof and breathable membrane is attached to the central cavity to seal the central flow channel groove. One end of the zone air channel is disposed at the edge of the sealed area of ​​the waterproof and breathable membrane, and the other end is connected to the air-bearing area.

[0029] In some embodiments of this application, one amplification cavity is provided with two flow channels, namely an inlet flow channel and an outlet flow channel; one end of the inlet flow channel is connected to the central flow channel groove, and the other end of the inlet flow channel is connected to one end of the amplification cavity; one end of the outlet flow channel is connected to the other end of the amplification cavity, and the port of the other end of the outlet flow channel is located in the central cavity and is sealed by the waterproof and breathable membrane.

[0030] In some embodiments of this application, the inlet channel is provided with a first barrier, and the outlet channel is provided with a second barrier.

[0031] In some embodiments of this application, the amplification cavity is provided with four cavities, which are arranged in a circle at equal intervals with the center of the central cavity as the center.

[0032] In some embodiments of this application, one amplification cavity and its corresponding inlet and outlet channels form a wing-shaped amplification unit, and four amplification units are symmetrically arranged to form a butterfly-wing-shaped amplification unit group.

[0033] In some embodiments of this application, at least four gas-containing regions are provided, and each is located between every two adjacent amplification units.

[0034] In some embodiments of this application, a transition gas zone is further provided between the gas-containing zones; the transition gas zone and the adjacent gas-containing zones are connected by a gas distribution channel.

[0035] In some embodiments of this application, the valve is a pin valve structure.

[0036] In some embodiments of this application, the valve includes a valve cavity, an elastic pad, and at least one protrusion;

[0037] The valve cavity has a first flow channel hole on its side and a second flow channel hole at its bottom; the elastic pad is located above the second flow channel hole; the protrusion is provided on the surface of the elastic pad facing the valve cavity, and / or is provided on the surface of the valve cavity at a position corresponding to the elastic pad, so that there is a gap between the elastic pad and the second flow channel hole.

[0038] In some embodiments of this application, the second flow channel hole is located at the center of the valve cavity; the protrusion is provided on the surface of the valve cavity and is located on the line connecting the first flow channel hole and the second flow channel hole.

[0039] In some embodiments of this application, the first flow channel hole is located on the upper part of the side of the valve cavity, and the corresponding lower part slopes downward from the outside to the inside.

[0040] In some embodiments of this application, the reagent kit assembly includes a shell, a sealing film, and an adhesive patch;

[0041] The housing has at least four liquid-containing cavities with openings facing the front. The liquid-containing cavities are pre-filled with corresponding test solutions. The sealing film is affixed to the front of the housing to seal the liquid-containing cavities, thereby forming a corresponding reagent package unit. One side of the adhesive attachment is used to connect to the front of the housing, and the other side is used to connect to the surface of the card plate. A cutout is formed on the adhesive attachment at the position corresponding to the liquid-containing cavity.

[0042] In some embodiments of this application, the first airflow channel, the second airflow channel, the third airflow channel, and the fourth airflow channel each include an upper airflow channel, a test liquid chamber, and a lower flow channel; one end of the upper airflow channel has the vent, and the other end is connected to the upper part of the test liquid chamber; one end of the lower flow channel is connected to the lower part of the test liquid chamber, and the other end is connected to the main flow channel; the test liquid chamber corresponds to the liquid-containing chamber, and after the reagent pack unit is broken, the test liquid inside it flows into the test liquid chamber and the lower flow channel in sequence.

[0043] In some embodiments of this application, a packaging breaker is also included; the packaging breaker is disposed in the test liquid chamber at a predetermined distance from the sealing film, and the packaging breaker breaks the sealing film when subjected to a preset pressure.

[0044] In some embodiments of this application, the ruptured component is a thermoplastic elastic rubber;

[0045] The edge of the test liquid chamber is provided with an injection groove, and all the injection grooves of the test liquid chambers are interconnected to form an injection flow channel, in which the thermoplastic elastic material is formed into the thermoplastic elastic rubber.

[0046] In some embodiments of this application, a partition strip is provided in the middle of the test liquid chamber to divide the test liquid chamber into an upper chamber and a lower chamber that are interconnected, and a partition injection groove is provided on the surface of the partition strip that is connected to the injection groove.

[0047] In some embodiments of this application, the arrangement of the liquid-containing cavities on the housing is as follows: several rows of liquid-containing cavities are provided from top to bottom, the liquid-containing cavities in each row are arranged at equal intervals, and each liquid-containing cavity in an even-numbered row corresponds to the gap between every two adjacent liquid-containing cavities in an odd-numbered row.

[0048] In some embodiments of this application, at least one flow guide group is provided in the liquid-containing cavity, and the flow guide group includes two flow guide plates symmetrically arranged on both sides of the liquid-containing cavity and inclined downward.

[0049] In some embodiments of this application, the cap includes a template and a stopper;

[0050] The sample loading plate has a sample loading port and a first fixing part; the sample loading plate is located at the top of the sample cavity;

[0051] The stopper includes a base plate, a plunger, and a second fixing part; one end of the plunger is disposed on the bottom surface of the base plate, and the other end is used to insert into the sample dispensing port to seal the sample dispensing port;

[0052] One end of the second fixing part is disposed on the bottom or side surface of the substrate, and the other end is connected to the first fixing part.

[0053] In some embodiments of this application, the first fixing part is a fixing hole, and the second fixing part is a fixing strip; one end of the fixing strip is connected to the side of the substrate through a bendable member.

[0054] In some embodiments of this application, the end of the fixing strip used for insertion into the fixing hole is provided with a locking member, which prevents the fixing strip from being pulled out after it is inserted into the fixing hole.

[0055] In some embodiments of this application, a sample dispensing tube extends from the sample dispensing port, and the plunger is shaped to cooperate with the sample dispensing tube; at least one inner groove is provided on the inner surface of the end of the sample dispensing tube away from the sample dispensing plate; an outer protrusion that cooperates with the inner groove is provided on the outer surface of the plunger at the corresponding position; a second inclined portion is formed from the outside to the inside at the end of the sample dispensing tube near the sample dispensing plate; and an inclined structure that cooperates with the second inclined portion is provided at the corresponding position of the plunger.

[0056] This application also provides a detection device, including the card box and supporting instruments as described in any of the preceding claims.

[0057] Compared with the prior art, the advantages of the card holder and detection device of this invention are as follows:

[0058] The cartridge and detection device of this invention arranges each reaction chamber on the cartridge body and independently seals the reagents required for the reaction in a reagent pack attached to the cartridge body. The supporting instrument controls the main flow channel, air flow channel and valve on the cartridge body, so that the reagent pack and the reaction chamber are selectively connected, thereby realizing the automated processing of nucleic acid extraction, amplification and detection. Only a few manual operation steps are required, the operation is simple, safe and convenient, the sealing is strong, and the detection results are more accurate. Attached Figure Description

[0059] To more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0060] Figure 1 This is an exploded view of the card box according to an embodiment of the present invention;

[0061] Figure 2 This is a schematic diagram of the front structure of the card box panel;

[0062] Figure 3 This is a schematic diagram of the back structure of the card box panel;

[0063] Figure 4 This is a schematic diagram of the main channel structure of the card box board;

[0064] Figure 5 This is a schematic diagram of the front axonometric structure of the card box panel;

[0065] Figure 6 This is a schematic diagram of the front structure of the card holder with the front film removed;

[0066] Figure 7 yes Figure 6 A schematic diagram of the back structure of the card holder;

[0067] Figure 8 yes Figure 6 A top-view structural diagram of the card box from the front;

[0068] Figure 9 yes Figure 6 A side view of the card holder.

[0069] Figure 10 This is a schematic diagram of the front structure of the PCR chamber;

[0070] Figure 11 This is a schematic diagram of the frontal axial structure of the PCR chamber. Figure 1 ;

[0071] Figure 12This is a schematic diagram of the frontal axial structure of the PCR chamber. Figure 2 ;

[0072] Figure 13 This is a schematic diagram of the central cavity and an amplification cavity;

[0073] Figure 14 This is an exploded structural diagram of a needle valve.

[0074] Figure 15 This is a structural diagram of the pin valve;

[0075] Figure 16 This is a front view of the needle valve structure.

[0076] Figure 17 This is a schematic diagram of the rear structure of the ejector pin valve.

[0077] Figure 18 yes Figure 16 Sectional view at point A-A;

[0078] Figure 19 This is a schematic diagram of the axial structure of the housing;

[0079] Figure 20 This is a front view structural diagram of the shell;

[0080] Figure 21 This is a top view of the shell structure.

[0081] Figure 22 yes Figure 4 Schematic diagram of the structure of the central airflow channel region;

[0082] Figure 23 yes Figure 5 Schematic diagram of the structure of the central airflow channel region;

[0083] Figure 24 This is a schematic diagram of the axial structure of the airflow channel region;

[0084] Figure 25 This is a schematic diagram of the fitting structure between the cap and the sample insertion cavity;

[0085] Figure 26 This is a schematic diagram of the structure of the sample inlet, sample tube, and sample addition chamber;

[0086] Figure 27 This is a schematic diagram of the plug's structure. Figure 1 ;

[0087] Figure 28 This is a schematic diagram of the plug's structure. Figure 2 ;

[0088] Figure 29 This is a front view structural diagram of the plug;

[0089] In the picture:

[0090] 1. Card holder body; 11. Card holder plate; 12. Front film; 13. Rear film;

[0091] 101. Sample addition chamber; 102. Internal control lyophilized bead chamber; 103. Sample processing chamber; 104. Magnetic bead storage chamber; 105. Waste liquid chamber; 106. Magnetic bead capture chamber; 107. Mixing chamber; 108. Blocking chamber; 109. PCR chamber; 110. Siphon bend; 111. Sample dispensing port;

[0092] 2. Reagent package assembly; 21. Shell; 22. Sealing film; 23. Attachment; 24. Limiting strip; 25. Flow guide plate; 201. First liquid chamber; 202. Second liquid chamber; 203. Third liquid chamber; 204. Fourth liquid chamber; 205. Fifth liquid chamber; 121. Lysis buffer package; 122. Binding buffer package; 123. First cleaning solution package; 124. Elution solution package; 125. Second cleaning solution package;

[0093] 3. Cap; 31. Sample plate; 311. Fixing hole; 312. Sample tube; 32. Plug; 321. Base plate; 322. Plunger; 323. Fixing strip; 324. Bendable part; 325. Locking part; 326. Guide strip; 327. Outer protrusion strip;

[0094] A1, First airflow channel; A2, Second airflow channel; A3, Third airflow channel; A4, Fourth airflow channel; A5, Fifth airflow channel; A6, Sixth airflow channel; A7, Seventh airflow channel; A8, Eighth airflow channel;

[0095] 131. Upper air passage; 132. Test liquid chamber; 133. Lower flow passage; 134. Injection molding tank; 135. Separator strip; 136. Separated injection molding tank;

[0096] 141. First branch; 142. Second branch; 143. Third branch; 144. Fourth branch; 145. Fifth branch; 146. Sixth branch; 147. Seventh branch; 148. Eighth branch; N1. Positive groove; N2. Back groove; N3. Connecting hole;

[0097] B1, First valve; B2, Second valve; B3, Third valve; B4, Fourth valve; B5, Fifth valve; B6, Sixth valve; B7, Seventh valve; B8, Eighth valve; B9, Ninth valve;

[0098] 151. Valve cavity; 152. Elastic pad; 153. Protrusion; 154. First flow channel hole; 155. Second flow channel hole;

[0099] 161. Central cavity; 162. Amplification cavity; 163. Zone flow channel; 1631. Inlet flow channel; 1632. Outlet flow channel; 164. Central flow channel groove; 165. Gas holding zone; 1651. First gas holding zone; 1652. Second gas holding zone; 166. Waterproof and breathable membrane; 167. Zone air channel; 168. Separating air channel; 169. Transition air zone; M1. First barrier; M2. Second barrier;

[0100] 4. Damaged packages. Detailed Implementation

[0101] The specific embodiments of the present invention will be described in further detail below with reference to the accompanying drawings and examples. The following examples are for illustrative purposes only and are not intended to limit the scope of the invention.

[0102] In the description of this invention, it should be understood that the terms "upper", "lower", "left", "right", "top", "bottom", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0103] It should be understood that the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the present invention.

[0104] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this invention, "a plurality of" means two or more, unless otherwise explicitly specified.

[0105] like Figure 1 As shown in Figure 29, a preferred embodiment of the present invention is a card box, which includes a card box body 1, a reagent pack group 2, and a cap 3.

[0106] Specifically, the cartridge body 1 is provided with a main channel, a valve group, a reaction chamber, and an airflow channel. The valve group includes several valves located at predetermined positions in the main channel, so that one end of the reaction chamber and the airflow channel can be selectively connected to the main channel, and the other end of the airflow channel has a vent for connecting an air pump.

[0107] The reaction chamber includes a sample chamber, a magnetic bead storage chamber 104, a magnetic bead capture chamber 106, a waste liquid chamber 105, a mixing chamber 107, and a PCR chamber 109. The sample chamber is connected to the first ends of both the magnetic bead storage chamber 104 and the magnetic bead capture chamber 106. The first end of the magnetic bead capture chamber 106 is also connected to the mixing chamber 107, and its opposite second end is connected to the waste liquid chamber 105. The mixing chamber 107 is connected to the PCR chamber 109. The sample chamber has a sample dispensing port 111, which is sealed with a cap 3. Magnetic particles, such as lyophilized magnetic beads, are pre-placed in the magnetic bead storage chamber 104. Lyophilized beads are pre-placed in the mixing chamber 107.

[0108] The reagent pack 2 is affixed to the surface of the cartridge body 1 and includes at least four independently sealed reagent pack units. The four reagent pack units are a lysis buffer pack 121, a binding buffer pack 122, a first cleaning buffer pack 123, and an elution buffer pack 124. Preferably, a second cleaning buffer pack 125 may also be included. Figure 2 and Figure 3 The numbers in the diagram are only for indicating the location of a reagent kit unit and do not represent the complete reagent kit unit.

[0109] The airflow channels include at least a first airflow channel A1, a second airflow channel A2, a third airflow channel A3, and a fourth airflow channel A4, which correspond to the lysis buffer package 121, the binding buffer package 122, the first washing buffer package 123, and the elution buffer package 124, respectively, and may also preferably include a fifth airflow channel A5, which corresponds to the second washing buffer package 125.

[0110] After the lysis buffer package 121 is broken, it flows into the first gas flow channel A1. The first gas flow channel A1 can be connected to the magnetic bead storage cavity 104 or to the sample cavity.

[0111] After the liquid package 122 is broken, it flows into the second airflow channel A2, which can be connected to the magnetic bead storage cavity 104 or the sample cavity.

[0112] The above steps are mainly to ensure that the lysis buffer, the magnetic beads (magnetic particles) in the magnetic bead storage cavity 104, and the binding fluid are mixed evenly in the sample cavity. When the first airflow channel A1 is connected to the magnetic bead storage cavity 104, the lysis buffer carries the magnetic beads to the sample cavity, and the binding fluid can flow directly into the sample cavity. Therefore, the second airflow channel A2 is connected to the sample cavity. When the first airflow channel A1 is directly connected to the sample cavity, the binding fluid carries the magnetic beads to the sample cavity, and in this case, the second airflow channel A2 needs to be connected to the magnetic bead storage cavity 104.

[0113] After the first cleaning solution package 123 is broken, it flows into the third airflow channel A3. The third airflow channel A3 can be connected to the first end of the sample chamber or the magnetic bead capture chamber 106. This step is mainly for cleaning the magnetic beads. The cleaning solution passes through the magnetic bead capture chamber 106 to clean the magnetic beads, and then the cleaning solution is injected into the waste liquid chamber 105. Therefore, the third airflow channel A3 can be directly connected to the first end of the magnetic bead capture chamber 106 for magnetic bead cleaning, or it can be connected to the sample chamber, so that the cleaning solution first flows through the sample chamber and then flows into the magnetic bead capture chamber 106 for magnetic bead cleaning.

[0114] After the second cleaning solution package 125 is broken, it flows into the fifth airflow channel A5, which can be connected to the first end of the sample chamber or the magnetic bead capture chamber 106. This step is mainly for secondary cleaning of the magnetic beads, and its principle and steps are the same as the first cleaning, so they will not be repeated here. Secondary cleaning of the magnetic beads is a preferred embodiment, but not an essential step.

[0115] After the eluent packet 124 is broken, it flows into the fourth gas flow channel A4, which is connected to the second end of the magnetic bead capture chamber 106. This step is mainly to elute the nucleic acid molecules adsorbed on the surface of the magnetic beads, and then push the eluent into the mixing chamber 107 to mix the eluent with the lyophilized beads in the mixing chamber 107.

[0116] After the elution buffer and lyophilized beads are mixed in the mixing chamber 107, the mixture is pushed to the PCR chamber 109 for amplification reaction.

[0117] In the above process steps, the flow of liquid is controlled by valve assembly and air pump.

[0118] Based on the above process steps, this application proposes a preferred embodiment of a card holder as follows:

[0119] See Figure 1 -4. The cartridge includes a cartridge body 1, a reagent pack assembly 2, and a cap 3. The cartridge body 1 includes a cartridge plate 11, a front membrane 12, and a rear membrane 13. The front membrane 12 and the rear membrane 13 are respectively attached to the front and back of the cartridge plate 11 to seal the cavity openings, slots, and cutouts on the front and back of the cartridge plate 11. In the following description, the descriptions involving left, right, top, and bottom positions are based on the front view of the cartridge plate 11.

[0120] In this embodiment, the sample chamber preferably includes a sample inlet chamber 101, an internal reference lyophilized bead chamber 102, a sample processing chamber 103, and a siphon bend 110, all located at a predetermined position in the center of the front of the cartridge plate 11. The sample inlet chamber 101 has a sample dispensing port 111 at its top, through which the sample to be tested is injected into the cartridge. The cap 3 is used to close the sample dispensing port 111. The internal reference lyophilized bead chamber 102 is located below the sample inlet chamber 101. The top of the internal reference lyophilized bead chamber 102 communicates with the bottom of the sample inlet chamber 101, and the bottom of the internal reference lyophilized bead chamber 102 communicates with one end of the siphon bend 110. The sample processing chamber 103 is located to the left of the sample addition chamber 101. The other end of the siphon bend 110 is connected to the top right side of the sample processing chamber 103. A sixth airway A6 is located at the top left side of the sample processing chamber 103, and the other end of the sixth airway A6 has an air vent (in the accompanying drawings, for ease of understanding and labeling, the marking line is placed at the air pump hole of the airway. For example, the A6 marking line in the figure is placed at the air pump hole of the sixth airway A6; the same applies to other airways). The internal reference lyophilized bead chamber 102 contains pre-placed internal reference lyophilized beads. These beads serve as an internal reference sample and monitor the entire cartridge process. If the internal reference lyophilized bead sample shows a fluorescent reaction, while the test sample does not, it indicates a problem with the test sample.

[0121] The magnetic bead storage chamber 104 is located to the left of the sample processing chamber 103. The mixing chamber 107 is located below the siphon bend 110, and a seventh airway A7 is provided at the top center line of the mixing chamber 107, with a vent at the other end of the seventh airway A7. The waste liquid chamber 105 is located to the right of the sample addition chamber 101, and an eighth airway A8 is provided at the top of the waste liquid chamber 105, with a vent at the other end of the eighth airway A8, which can be used as an exhaust port. The PCR chamber 109 is located on the right side of the front of the cartridge plate 11.

[0122] In some embodiments of this application, a blocking cavity 108 is further provided between the mixing cavity 107 and the PCR cavity 109. The blocking cavity 108 is located below the sample addition cavity 101 and connects to the main channel (connecting branch) between the mixing cavity 107 and the PCR cavity 109. In some embodiments of this application, a solid wax is provided at the top inner part of the blocking cavity 108, which melts when heated to a predetermined temperature. The wax seals the main channel, thereby blocking the connection between the mixing cavity 107 and the PCR cavity 109. This seals the PCR cavity 109 after the amplification reaction is completed, preventing the amplification products in the PCR cavity 109 from leaking out of the cartridge through the flow channel and contaminating the instrument or the environment.

[0123] The reagent pack 2 is attached to the back of the upper left side of the card box plate 11 and includes five independent sealed reagent pack units. The five reagent pack units are lysis buffer pack 121, binding buffer pack 122, first cleaning buffer pack 123, elution buffer pack 124 and second cleaning buffer pack 125 (the labels in the figure are only for the location of the reagent pack units and do not represent the complete reagent pack units).

[0124] See Figure 4 The main channels on the cardboard 11 include the first branch 141, the second branch 142, the third branch 143, the fourth branch 144, the fifth branch 145, the sixth branch 146, the seventh branch 147, and the eighth branch 148.

[0125] One end of the first branch 141 is connected to the liquid outlet of the first airflow channel A1, and the other end of the first branch 141 is connected in sequence to the magnetic bead storage cavity 104, the first valve B1 and the sample processing cavity 103.

[0126] One end of the second branch 142 is connected to the liquid outlet of the second airflow channel A2, and the other end of the second branch 142 is connected to the second valve B2 and then connected to the first branch 141. This connection point is denoted as C1.

[0127] One end of the third branch 143 is connected to the liquid outlet of the third airflow channel A3, and the other end of the third branch 143 is connected to the fourth valve B4 and the fifth valve B5 in sequence before connecting to the first branch 141. This connection point is denoted as C2.

[0128] One end of the fourth branch 144 is connected to the liquid outlet of the fourth airflow channel A4, and the other end of the fourth branch 144 is connected in sequence to the seventh valve B7 and the end (second end) of the magnetic bead capture chamber 106 near the left side of the card plate 11.

[0129] One end of the fifth branch 145 is connected to the liquid outlet of the fifth airflow channel A5, and the other end of the fifth branch 145 is connected to the third branch 143, with the connection point C3 located between the fourth valve B4 and the fifth valve B5.

[0130] One end of the sixth branch 146 is connected to the bottom of the sample processing chamber 103 (or connected to the section of the first branch 141 near the sample processing chamber 103), and the other end of the sixth branch 146 is connected to the third valve B3 and then connected to the end (first end) of the magnetic bead capture chamber 106 near the right side of the card plate 11.

[0131] One end of the seventh branch 147 is connected to the upper part of the waste liquid chamber 105, and the other end of the seventh branch 147 is connected in sequence to the sixth valve B6 and the end (second end) of the magnetic bead capture chamber 106 near the left side of the card plate 11.

[0132] One end of the eighth branch 148 is connected to the end of the magnetic bead capture chamber 106 near the right side of the card plate 11 (the first end), and the other end of the eighth branch 148 is connected in sequence to the eighth valve B8, the mixing chamber 107, the blocking chamber 108, the ninth valve B9 and the PCR chamber 109.

[0133] In the above embodiments, see Figure 1 -9. The sample addition chamber 101, internal control lyophilized bead chamber 102, sample processing chamber 103, waste liquid chamber 105, mixing chamber 107, and blocking chamber 108 are all recessed cavities formed by the front of the cartridge plate 11 protruding towards its back. When the front membrane 12 is attached to the front of the cartridge plate 11, the recessed cavities are sealed to form the aforementioned reaction chambers. In some embodiments of this application, the sample addition chamber 101 and the sample processing chamber 103 near the bottom are inclined towards the front of the cartridge plate 11 to facilitate liquid outflow. A groove is cut on the front of the cartridge plate 11, and the front membrane 12 seals the groove to form a siphon bend 110. See also Figure 7 A perforated hole is made in the card holder plate 11. A protrusion 1041 that protrudes slightly beyond the back of the card holder plate 11 is provided on the back of the card holder plate 11 around the edge of the perforated hole. The protrusion 1041 has a flow channel that communicates with the first valve B1. The front membrane 12 seals the front of the perforated hole to form the magnetic bead storage cavity 104.

[0134] In the above embodiments, the main channel includes a first branch 141, a second branch 142, a third branch 143, a fourth branch 144, a fifth branch 145, a sixth branch 146, a seventh branch 147, and an eighth branch 148, each of which can be formed by a groove provided on one surface (front or back) of the card holder plate 11. In some embodiments of this application, a positive and negative groove structure is proposed, and each of the above-mentioned branches can be composed of at least one of these positive and negative groove structures. See also Figure 10 Taking the eighth branch 148 as an example, the positive and negative groove structure includes a positive groove N1, a back groove N2, and a connecting hole N3. The positive groove N1 is a groove on the front side of the card holder plate 11 (solid line segment in the figure), and the back groove N2 is a groove on the back side of the card holder plate 11 (dashed line segment in the figure). The connecting hole N3 is located at the intersection of the ports of the positive groove N1 and the back groove N2, used to connect the ports of the positive groove N1 and the back groove N2. The front membrane 12 seals the positive groove N1, the rear membrane 13 seals the back groove N2, and the connecting hole N3 connects the positive groove N1 and the back groove N2, thereby forming a flow channel.

[0135] In the above embodiments, see Figure 10 -12, the PCR chamber 109 includes a central chamber 161, an amplification chamber 162, a zone flow channel 163, a central flow channel groove 164, a gas-containing zone 165, a waterproof and breathable membrane 166, a zone air channel 167, a branch air channel 168, and a transition air zone 169.

[0136] A central flow channel groove 164 is located on one surface (front) of the central cavity 161, and a flow channel (i.e., the back groove N2 section of the eighth branch 148) is located on the opposite surface (back) of the central cavity 161. The eighth branch 148 communicates with one end of the central flow channel groove 164, and the other end of the central flow channel groove 164 communicates with the zone flow channel 163. A waterproof and breathable membrane 166 is attached to the central cavity 161 to seal the central flow channel groove 164. A zone air channel 167 is located at the edge of the sealed area of ​​the waterproof and breathable membrane 166 and communicates with the air-containing zone 165. See also Figure 12 The height of the central flow channel groove 164 is approximately half the height of the central cavity 161. When the waterproof and breathable membrane 166 is attached to the central cavity 161, the upper half of the central cavity 161 is not sealed by the waterproof and breathable membrane 166. The air passage 167 is actually the groove between the upper half of the central cavity 161 and the gas-containing area 165. In this embodiment, a waterproof and breathable membrane 166 is provided on the opposite side (front) of the liquid inlet (the eighth branch 148 on the back), and its sealing edge is connected to the gas-containing area 165. When the mixed liquid in the mixing chamber 107 enters the central flow channel groove 164 of the central cavity 161, the air bubbles it carries will be released from the waterproof and breathable membrane 166 and enter the gas-containing area 165, so that the mixed liquid entering the amplification chamber 162 does not carry air bubbles, which facilitates better amplification steps.

[0137] In some embodiments of this application, see Figure 10 and Figure 13 Each amplification chamber 162 has two flow channels 163, namely an inlet flow channel 1631 and an outlet flow channel 1632. One end of the inlet flow channel 1631 is connected to the central flow channel groove 164, and the other end of the inlet flow channel 1631 is connected to one end of the amplification chamber 162. One end of the outlet flow channel 1632 is connected to the other end of the amplification chamber 162, and the other end of the outlet flow channel 1632 is located in the central chamber 161 and sealed by a waterproof and breathable membrane 166. The mixed solution in the central flow channel groove 164 enters the amplification chamber 162 from the inlet flow channel 1631. When the amplification chamber 162 is full of the mixed solution, the excess mixed solution flows into the outlet flow channel 1632. When the outlet flow channel 1632 is also full, the mixed solution stops entering the inlet flow channel 1631 because it cannot pass through the waterproof and breathable membrane 166.

[0138] In some embodiments of this application, a first barrier M1 is provided on the inlet flow channel 1631, and a second barrier M2 is provided on the outlet flow channel 1632. In fact, the first barrier M1 and the second barrier M2 are a flow channel interruption structure of a section of the unwelded pre-film 12. See details... Figure 13When the front membrane 12 is laser-welded to the surface of the cartridge plate 11, the welding line is approximately 0.1 mm from the outer edge of the flow channel; that is, the area outside the dashed circle X in the figure is the welding area. Since the first barrier M1 and the second barrier M2 are non-welded areas, the front membrane 12 is merely attached to the surface of the cartridge plate 11. Therefore, when the flow rate or pressure of the mixture is high, it will squeeze the front membrane 12 at the partition, causing the front membrane 12 to arch outwards, and the mixture can still flow through the partition (as shown by the arrow in the figure). The first barrier M1 and the second barrier M2 can play a certain role in flow obstruction, but they do not completely block the liquid flow. Therefore, the mixture can flow between the inlet flow channel 1631, the amplification chamber 162, and the outlet flow channel 1632. After the amplification chamber 162 is filled, before the heating and cooling cycle, it is necessary to completely block the liquid flow in the inlet channel 1631 and the outlet channel 1632. At this time, the waterproof and breathable membrane 166 is the first barrier, and the front membrane 12 at the first barrier M1 and the second barrier M2 is pressed by the top pressure rod of the matching instrument as the second barrier. The double guarantee completely blocks the liquid flow in the inlet channel 1631 and the outlet channel 1632.

[0139] In some embodiments of this application, four amplification cavities 162 are provided, and are arranged in a circumferential pattern with the center of the central cavity 161 as the center. One amplification cavity 162 and its corresponding inlet channel 1631 and outlet channel 1632 form a wing-shaped amplification unit, and four amplification units are symmetrically arranged to form a butterfly-wing-shaped amplification unit group. In some embodiments of this application, at least four gas-containing regions 165 are provided, and are respectively located between each pair of adjacent amplification units. A transition gas region 169 is also provided between each pair of adjacent gas-containing regions 165, and the transition gas region 169 and its adjacent gas-containing region 165 are connected by a gas distribution channel 168. The central cavity 161 and the waterproof and breathable membrane 166 are both circular. With the center of the central cavity 161 as the center of the circumference, and with the position of the channel as 0°, the four amplification cavities 162 are located at positions of 45°, 135°, 225° and 315° on the circumference, respectively. Specifically, the gas-bearing zone 165 includes a first gas-bearing zone 1651 and a second gas-bearing zone 1652. There are two first gas-bearing zones 1651, located at the 90° and 270° axes respectively, and their shape is a near-triangular shape corresponding to the fin-like gaps. One corner is connected to the central cavity 161 via a gas distribution channel 168, and the other two corners are connected to one end of the transition gas zone 169 via gas distribution channels 168. There are four second gas-bearing zones 1652, two of which are located on opposite sides of the flow channel and are connected to each other via gas distribution channels 168. The remaining two are symmetrically located on opposite sides of the flow channel and are connected to the central cavity 161 via gas distribution channels 168 and zone gas channels 167. The other end of the transition gas zone 169 is connected to the second gas-bearing zone 1652 via a gas distribution channel 168. See also... Figure 11-12, the gas-containing area 165 and the transition gas area 169 are both hollow areas. The gas distribution channel 168 and the zone gas channel 167 are both grooves on the cartridge body 1. The zone flow channel 163 is arranged in a positive and negative groove structure. After the mixed liquid in the mixing chamber 107 flows into each amplification chamber 162, the optical module of the matching instrument is located at the corresponding position of the PCR chamber 109 on the front of the cartridge, and the thermal module is located at the corresponding position of the PCR chamber 109 on the back of the cartridge. The optical module and the thermal module clamp the cartridge from both sides. During amplification, the thermal module cycles the temperature of the amplification chamber 162. After amplification, different wavelengths of light are used to excite the amplified reactants in the amplification chamber 162 to detect the concentration of the amplified reactants in the amplification chamber 162. Specifically, the optical module comprises four sub-modules: a red module, a green module, a yellow module, and a blue module. These four sub-modules are placed on four amplification chambers 162 respectively to detect different types of fluorescence after the reagent reaction within each chamber. Each amplification chamber 162 is detected by all four sub-modules in turn. Since the four amplification chambers 162 are designed on a circumference, the optical module only needs to rotate to allow the four sub-modules to detect different chambers 162 in turn. The optical module does not require additional travel, effectively improving detection efficiency.

[0140] In the above embodiments, the valve group includes valves B1, B2, B3, B4, B5, B6, B7, B8, and B9. These valves can employ any valve body structure in the prior art that adapts to a cartridge structure and enables liquid flow control through cooperation with equipment and instruments; a pin valve structure is preferred.

[0141] In some embodiments of this application, a preferred pin valve structure is proposed.

[0142] See Figure 14-18. The pin valve structure proposed in this application includes a valve cavity 151, an elastic pad 152, and at least one protrusion 153. The valve cavity 151 has a first flow channel hole 154 on its side and a second flow channel hole 155 on its bottom. The elastic pad 152 is located above the second flow channel hole 155. The protrusion 153 is disposed on the surface of the elastic pad 152 facing the valve cavity 151, and / or at a position on the surface of the valve cavity 151 corresponding to the elastic pad 152, creating a gap between the elastic pad 152 and the second flow channel hole 155. Preferably, the second flow channel hole 155 is located at the center of the valve cavity 151. One protrusion 153 is provided, and the protrusion 153 is disposed on the surface of the valve cavity 151 and located on the line connecting the first flow channel hole 154 and the second flow channel hole 155. In some embodiments of this application, the protrusion 153 is arched. In some embodiments of this application, the valve cavity 151 is circular in shape, and the elastic pad 152 is also circular in shape, with a diameter slightly smaller than that of the valve cavity 151. The elastic pad 152 is preferably a silicone pad. In some embodiments of this application, the side of the valve cavity 151 slopes downwards from the outside to the inside. In some embodiments of this application, the first flow channel hole 154 is located at the upper part of the side of the valve cavity 151, and the corresponding lower part slopes downwards from the outside to the inside to facilitate liquid flow into the valve cavity 151.

[0143] The needle valve structure proposed in this application, due to the presence of the protrusion 153, creates a gap between the elastic pad 152 and the second flow channel hole 155 when the elastic pad 152 is not subjected to external force. Liquid can flow into the valve chamber 151 from the first flow channel hole 154, and then into the second flow channel hole 155, thus flowing out of the needle valve structure along the flow channel. When the elastic pad 152 is subjected to a predetermined pressure, it deforms and blocks the second flow channel hole 155, preventing liquid from flowing into the second flow channel hole 155. That is, the needle valve structure blocks the liquid flow. Because the elastic pad 152 is elastic, when the external force is removed, the elastic pad 152 returns to its original shape, restoring to the state where there is a gap between the elastic pad 152 and the second flow channel hole 155, allowing liquid to flow from the needle valve structure.

[0144] The valve cavity 151 of the ejector valve structure proposed in this application can be directly opened on the front side of the cartridge plate 11. In conjunction with the flow channel with the positive and negative groove structure adopted in the above embodiment, the first flow channel hole 154 is connected to the positive groove N1 on the front side of the cartridge plate 11, and the second flow channel hole 155 is connected to the back groove N2 on the back side of the cartridge plate 11. The ejector valve structure can be regarded as a connecting hole N3 with controllable flow obstruction function. Its structure is simple, easy to control and reliable.

[0145] In the above embodiments, see Figure 1 The reagent pack 2 is affixed to the back of the upper left side of the card box plate 11. The reagent pack 2 includes a shell 21, a sealing film 22, and an attachment 23.

[0146] See Figure 19 -21. The housing 21 has five liquid-containing chambers with openings facing the front, including: a first liquid-containing chamber 201 pre-filled with lysis buffer, a second liquid-containing chamber 202 pre-filled with binding buffer, a third liquid-containing chamber 203 pre-filled with cleaning buffer, a fourth liquid-containing chamber 204 pre-filled with elution buffer, and a fifth liquid-containing chamber 205 pre-filled with secondary cleaning buffer. A sealing film 22 is affixed to the front of the housing 21 to seal the liquid-containing chambers, thereby forming five reagent package units: lysis buffer package 121, binding buffer package 122, first cleaning buffer package 123, elution buffer package 124, and second cleaning buffer package 125. One side of the attachment 23 is used to connect to the front of the housing 21, and the other side is used to connect to the back of the card plate 11. The attachment 23 has a cutout at the position corresponding to the liquid-containing chamber, that is, the attachment 23 does not cover the sealing film 22.

[0147] In some embodiments of this application, see Figure 22 The first airflow channel A1, the second airflow channel A2, the third airflow channel A3, the fourth airflow channel A4, and the fifth airflow channel A5 each include an upper airflow channel 131, a test liquid chamber 132, and a lower flow channel 133. One end of the upper airflow channel 131 has a vent, and the other end is connected to the upper part of the test liquid chamber 132. One end of the lower flow channel 133 is connected to the lower part of the test liquid chamber 132, and the other end is connected to the main flow channel. The test liquid chamber 132 corresponds to the liquid-containing chamber; after the reagent package unit is broken, the test liquid inside flows sequentially into the test liquid chamber 132 and the lower flow channel 133. Specifically, the lower flow channel 133 of the first airflow channel A1 is connected to one end of the first branch 141 of the main flow channel; the lower flow channel 133 of the second airflow channel A2 is connected to one end of the second branch 142 of the main flow channel; the lower flow channel 133 of the third airflow channel A3 is connected to one end of the third branch 1431 of the main flow channel; the lower flow channel 133 of the fourth airflow channel A4 is connected to one end of the fourth branch 144 of the main flow channel; and the lower flow channel 133 of the fifth airflow channel A5 is connected to one end of the fifth branch 145 of the main flow channel.

[0148] In the above embodiments, see Figure 22 -24, the test liquid chamber 132 is formed by hollowing out the position of the card plate 11 corresponding to the liquid chamber. The upper air channel 131 and the lower flow channel 133 are formed by interlacing grooves on the front and back of the card plate 11, that is, the upper air channel 131 and the lower flow channel 133 can adopt a positive and negative groove structure.

[0149] In some embodiments of this application, a packaging breaker 4 is also included. The packaging breaker 4 is disposed in the test liquid chamber 132 at a predetermined distance from the sealing film 22. When the packaging breaker 4 is subjected to a preset pressure, it breaks the sealing film 22.

[0150] In some embodiments of this application, the packaging component 4 is made of thermoplastic elastic rubber. For details, see [link to relevant documentation]. Figure 22-24, the edge of the test liquid cavity 132 is provided with an injection molding groove 134. In some embodiments of this application, a partition strip 135 is also provided in the middle of the test liquid cavity 132 to divide the test liquid cavity 132 into an interconnected upper cavity and a lower cavity, and a partition injection molding groove 136 communicating with the injection molding groove 134 is provided on the surface of the partition strip 135. All the injection molding grooves 134 and partition injection molding grooves 136 of the test liquid cavities 132 are interconnected to form an injection flow channel, and the thermoplastic elastic material is formed into a piece of thermoplastic elastic rubber in the injection flow channel, such as Figure 1 and Figure 6 As shown. See also the corresponding information. Figure 1 The front membrane 12 is hollowed out at the corresponding position of the package breaking component 4 so that the pressing module of the matching instrument can squeeze the package breaking component 4.

[0151] In actual use, the pressing module of the accompanying instrument squeezes the thermoplastic elastic rubber, utilizing its excellent extensibility to break the sealing film 22, allowing the test liquid in the liquid chamber to flow out. In this embodiment, an injection channel is designed around the edge of the test liquid chamber 132 to allow the thermoplastic elastic rubber to be molded. This ensures that the resulting package break 4 fits snugly against the test liquid chamber 132, effectively preventing displacement of the package break 4. Furthermore, a partition strip 135 with a dividing injection groove 136 is provided in the middle of the test liquid chamber 132. This not only supports the thermoplastic elastic rubber but also facilitates simultaneous squeezing and breaking of the package from both the upper and lower chambers by the accompanying instrument, improving the package breaking efficiency.

[0152] In some embodiments of this application, the arrangement of the liquid-containing cavities on the housing 21 is as follows: several rows of liquid-containing cavities are arranged from top to bottom, with the cavities in each row arranged at equal intervals, and the gap between each pair of adjacent cavities in the even-numbered rows corresponding to the gap between each pair of adjacent cavities in the odd-numbered rows. For example, in this embodiment, there are five liquid-containing cavities, and the arrangement of the first liquid-containing cavity 201, the second liquid-containing cavity 202, the third liquid-containing cavity 203, the fourth liquid-containing cavity 204, and the fifth liquid-containing cavity 205 is as follows: Figure 20 As shown. The arrangement of the above-mentioned liquid-containing chambers facilitates better airflow channel layout, such as... Figure 22 As shown, the upper air passage 131 of the second air passage A2 passes between the test liquid chambers 132 corresponding to the first air passage A1 and the fifth air passage A5, and is connected to the test liquid chamber 132 corresponding to the second air passage A2.

[0153] In some embodiments of this application, see Figure 18-19. The liquid-containing cavity is provided with at least one flow guide group, which includes two flow guide plates 25 symmetrically arranged on both sides of the liquid-containing cavity and inclined downwards. In some embodiments of this application, the liquid-containing cavity is elongated, with its two ends forming upward and downward protruding pointed arcs, respectively. In some embodiments of this application, the midline of the liquid-containing cavity divides the liquid-containing cavity into an upper liquid-containing cavity and a lower liquid-containing cavity, and there are two flow guide groups, one in the upper liquid-containing cavity and the other in the lower liquid-containing cavity. The above-mentioned structural design of the liquid-containing cavity and the flow guide plates 25 help to ensure that the test liquid in the liquid-containing cavity flows out as much as possible after the package is broken.

[0154] In some embodiments of this application, the sealing film 22 can be a single sheet for sealing the liquid cavity, or it can include multiple individual sealing films equal to the number of liquid cavities. The shape of each individual sealing film matches the liquid cavity, and each individual sealing film seals one liquid cavity. Preferably, the sealing film 22 is an aluminum-plastic film.

[0155] In some embodiments of this application, the attachment 23 is preferably pressure-sensitive adhesive, the shape of which is consistent with the shape of the housing 21, so that the housing 21, except for the liquid cavity, has pressure-sensitive adhesive, which is beneficial for firmly attaching it to the back of the card holder plate 11. See also some embodiments of this application. Figure 3 and Figure 7 The back of the card box plate 11 is provided with several limiting strips 24 that fit the shape of the shell 21. The edge of the attachment 23 is located inside the limiting strips 24 to prevent the reagent pack 2 from shifting.

[0156] In the above embodiments, see Figure 25 -29, the cap 3 includes a sample feeding plate 31 and a stopper 32. The sample feeding plate 31 has a sample feeding port 111 and a fixing hole 311 (first fixing part). The stopper 32 includes a base plate 321, a plunger 322 and a fixing strip 323 (second fixing part). One end of the plunger 322 is located on the bottom surface of the base plate 321, and the other end is used to insert into the sample feeding port 111 to seal the sample feeding port 111. One end of the fixing strip 323 is located on the bottom or side surface of the base plate 321, and the other end is used to insert into the fixing hole 311.

[0157] In some embodiments of this application, one end of the fixing strip 323 is connected to the side of the substrate 321 via a bendable member 324. In some embodiments of this application, the position of the fixing hole 311 corresponds to the position where the fixing strip 323 is bent to be perpendicular to the template 31. When the template 31 is on a horizontal plane, that is, when the fixing strip 323 is bent to 90°, it is inserted vertically into the fixing hole 311.

[0158] In some embodiments of this application, the end of the fixing strip 323 used for insertion into the fixing hole 311 is provided with a locking member 325, which prevents the fixing strip 323 from being pulled out after insertion into the fixing hole 311. In some embodiments of this application, the edge of the fixing hole 311 forms a first inclined portion from the outside to the inside, and the locking member 325 is an elastic conical member that cooperates with the fixing hole 311. In some embodiments of this application, the fixing hole 311 is square in shape, and the locking member 325 is frustoconical in shape. In some embodiments of this application, the front end of the locking member 325 is provided with a guide strip 326, the width of which is smaller than the width of the fixing hole 311, so that the guide strip 326 guides the fixing strip 323 into the fixing hole 311, facilitating operation by technicians.

[0159] In some embodiments of this application, a sample dispensing tube 312 extends from the sample dispensing port 111, and the plunger 322 is shaped to mate with the sample dispensing tube 312. In some embodiments of this application, at least one inner groove is provided on the inner surface of the end of the sample dispensing tube 312 away from the sample dispensing plate 31, and an outer protrusion 327 mates with the inner groove is provided on the outer surface of the plunger 322 at the corresponding position. In some embodiments of this application, a second inclined portion is formed from the outside to the inside at the end of the sample dispensing tube 312 near the sample dispensing plate 31, and the plunger 322 at the corresponding position is provided with an inclined structure that mates with the second inclined portion.

[0160] In this embodiment, the sample plate 31 is located at the top of the sample addition cavity 101 and is connected to the surface of the sample addition cavity 101. The sample tube 312 extends into the sample addition cavity 101. The sample tube 312 facilitates the use of pipettes for sample addition.

[0161] The sealing cap 3 proposed in this application provides a simple connection and fit structure (fixing strip 323 and fixing hole 311) between the cap 32 and the sample filling port 111, effectively preventing the cap 32 from being lost and avoiding unnecessary trouble for the testing work. Furthermore, the ingenious design of multiple connection structures makes the seal more reliable and helps improve the sealing performance of the cartridge after sample filling.

[0162] The present invention also provides a detection device, including the aforementioned cartridge and supporting instruments used in conjunction with the cartridge. The supporting instruments mainly include: an air pump connected to the air inlets of each airway; a drive module (center rod) at each corresponding position of a valve, used to drive the opening and closing of the valve; a magnetic attraction module at each corresponding position of the magnetic bead capture chamber 106 and the sample processing chamber 103, used to provide magnetic attraction force to control the attraction or release of magnetic beads; an ultrasonic module and a thermal circulation module at the corresponding position of the sample processing chamber 103, which can be used to mix and heat the sample mixture; a pressing module at the corresponding position of the packaging breaking component 4, used to provide a predetermined pressing force to squeeze the packaging breaking component 4 to break the seal of the reagent package; and an amplification heating module and an optical detection module at the corresponding position of the PCR chamber 109, wherein the amplification heating module is used to cycle the temperature of the PCR chamber, and the optical detection module is used to detect the amplification status within the PCR chamber.

[0163] The workflow of the card box structure proposed in the above embodiments is as follows:

[0164] Step 1, Sample loading: Add the patient sample to be tested into the sample loading chamber 101 through the sample loading port 111, and then close the cap 3 to seal the cartridge. Since there is a siphon bend 110 between the sample loading chamber 101 and the sample processing chamber 103, the sample will temporarily stay in the siphon bend 110 and will not flow directly into the sample processing chamber 103.

[0165] Step 2: Connect the accompanying instrument: Insert the card holder into the accompanying instrument. Specifically, the accompanying instrument has slots that allow the card holder to be inserted vertically. The air inlets of the first airflow channel A1, second airflow channel A2, third airflow channel A3, fourth airflow channel A4, fifth airflow channel A5, sixth airflow channel A6, and seventh airflow channel A7 on the card holder body 1 are all connected to the air pump of the accompanying instrument, and air pressure valves can be installed at the connection points. Furthermore, the center rod of the accompanying instrument is aligned with each valve (first valve B1, second valve B2, third valve B3, fourth valve B4, fifth valve B5, sixth valve B6, seventh valve B7, eighth valve B8, and ninth valve B9), and the initial state of all the center rods is in the state of compressing the elastic pads to close all valves, so that all channels inside the card holder body 1 are in the closed state.

[0166] Step 3, Sample Pretreatment: After sample addition, the sample will first mix with the internal control lyophilized beads in the internal control lyophilized bead chamber, and then remain in the siphon bend 110. After the detection begins, the accompanying instrument's air pressure pump is used to draw air from the vent of the sixth airway A6 (the operation of the accompanying instrument's air pressure pump will not be mentioned again in the following description, only the air passage's ventilation or evacuation status will be described), so that the sample remaining in the siphon bend 110 is drawn into the sample processing chamber 103.

[0167] Step 4: Release the lysis buffer: The area corresponding to the lysis buffer package 121 is squeezed by the pressing module of the accompanying instrument, thereby puncturing the sealing membrane 22 of the lysis buffer package 121 and allowing the lysis buffer to flow from the lysis buffer package 121 into the test solution chamber 132 of the first airflow channel A1 (the operation of the pressing module of the accompanying instrument will not be mentioned again below; only the state of the reagent package will be described). At this time, since all valves in the channel are closed, the lysis buffer will temporarily remain in the test solution chamber 132 and will not automatically flow into the various chambers of the cartridge body 1. Then, the central rod corresponding to the first valve B1 is released, thereby opening the first valve B1 (the operation of the central rod of the accompanying instrument will not be mentioned again below; only the opening and closing state of the valve will be described). Simultaneously, air is introduced from the first airflow channel A1, allowing the lysis buffer to flow into the magnetic bead storage chamber 104, mixing the lyophilized magnetic beads in the magnetic bead storage chamber 104, and carrying all the magnetic beads into the sample processing chamber 103. By continuously introducing air through the first airflow channel A1, and utilizing the bubbles continuously generated from the bottom of the sample processing chamber 103, the lysis solution and the sample are thoroughly mixed. Then, the first valve B1 is closed. During the mixing process, the mixture can be heated to 85°C for thermal lysis using the thermal circulation module of the accompanying instrument.

[0168] Step 5: Release the binding fluid: Puncture the binding fluid pack 122 to allow the binding fluid to flow out into the test fluid chamber 132 of the second airflow channel A2. At this time, since the corresponding needle valve of the channel is closed, the binding fluid will temporarily remain in the test fluid chamber 132 and will not automatically flow into the various chambers of the cartridge body 1. Open the second valve B2 and introduce air through the second airflow channel A2 to push the binding fluid into the sample processing chamber 103. Continuously introduce air through the second airflow channel A2, using the bubbles continuously generated from the bottom of the sample processing chamber 103 to mix the binding fluid, magnetic beads, and the lysed sample. Then close the second valve B2.

[0169] In the above steps, the lysis buffer is first released and mixed with the magnetic beads in the sample processing chamber 103, and then the binding solution is released into the sample processing chamber 103 and mixed together. However, in the scheme of this application, the lysis buffer can also be released into the sample processing chamber 103 first, and then the binding solution is released and mixed with the magnetic beads, and then they are mixed together in the sample processing chamber 103. The specific ventilation and valve control of this method are the same as the previous method, and will not be repeated here.

[0170] Step 6: Cleaning the magnetic beads: In this embodiment, there are two methods for cleaning the magnetic beads.

[0171] The first magnetic bead cleaning method involves adsorbing magnetic beads into the magnetic bead capture chamber 106 for cleaning. The accompanying instrument only has a magnetic suction module at the corresponding position in the magnetic bead capture chamber 106. The specific steps include: opening the third valve B3 and the sixth valve B6, and simultaneously activating the magnetic suction module. Air is introduced through the sixth air passage A6, pushing the mixed liquid in the sample processing chamber 103 sequentially into the magnetic bead capture chamber 106 and the waste liquid chamber 105. When the mixed liquid passes through the magnetic bead capture chamber 106, under the magnetic attraction of the magnetic suction module, the magnetic beads are uniformly adsorbed onto the inner wall of the magnetic bead capture chamber 106, while the remaining liquid portion of the mixed liquid is pushed into the waste liquid chamber 105. Then, the third valve B3 and the sixth valve B6 are closed. The first cleaning liquid pack 123 is punctured, allowing the cleaning liquid to flow out from the first cleaning liquid pack 123 to the test liquid chamber 132 of the third air passage A3. At this time, since the corresponding valves in the channel are closed, the cleaning fluid will temporarily remain in the test solution chamber 132 and will not automatically flow into the various chambers of the cartridge body 1. Open the fourth valve B4 and the fifth valve B5, and introduce air through the third airflow channel A3 to push the cleaning fluid into the sample processing chamber 103, then close the fourth valve B4 and the fifth valve B5. Open the third valve B3 and the sixth valve B6, and introduce air through the sixth airflow channel A6 to push the cleaning fluid sequentially into the magnetic bead capture chamber 106 and the waste liquid chamber 105, completing the first cleaning of the magnetic beads. Continue to puncture the second cleaning fluid pack 125, open the fifth valve B5, and introduce air through the fifth airflow channel A5 to push the cleaning fluid into the sample processing chamber 103, then close the fifth valve B5. Open the third valve B3 and the sixth valve B6, and introduce air through the sixth airflow channel A6 to push the cleaning fluid sequentially into the magnetic bead capture chamber 106 and the waste liquid chamber 105, completing the second cleaning of the magnetic beads. Air is continuously introduced through the sixth airway A6 to dry the magnetic bead capture chamber 106.

[0172] The second magnetic bead cleaning method involves first cleaning the magnetic beads in the sample processing chamber 103, followed by a second cleaning in the magnetic bead capture chamber 106. The instrument is equipped with magnetic suction modules at corresponding positions in both the magnetic bead capture chamber 106 and the sample processing chamber 103. The specific steps include: activating the magnetic suction module located at the corresponding position in the sample processing chamber 103, and opening the third valve B3 and the sixth valve B6, allowing air to enter through the sixth air passage A6. Under the magnetic attraction of the magnetic suction module, the magnetic beads are evenly adsorbed onto the inner wall of the sample processing chamber 103, while the remaining liquid portion of the mixture is pushed into the waste liquid chamber 105. Then, the third valve B3 and the sixth valve B6 are closed. The first cleaning solution pack 123 is punctured, allowing the cleaning solution to flow from the first cleaning solution pack 123 into the test solution chamber 132 of the third air passage A3. At this time, because the corresponding valves in the passages are closed, the cleaning solution will temporarily remain in the test solution chamber 132 and will not automatically flow into the various chambers of the cartridge body 1. Open the fourth valve B4 and the fifth valve B5, and introduce air through the third airflow channel A3 to push the cleaning solution into the sample processing chamber 103. Then, close the magnetic attraction module of the instrument and continuously introduce air through the third airflow channel A3. Utilize the bubbles continuously generated from the bottom of the sample processing chamber 103 to thoroughly mix the cleaning solution with the magnetic beads, and then close the fourth valve B4 and the fifth valve B5. Open the magnetic attraction module located at the corresponding position in the magnetic bead capture chamber 106, and open the third valve B3 and the sixth valve B6, introducing air through the sixth airflow channel A6. Under the magnetic attraction of the magnetic attraction module, the magnetic beads will be evenly adsorbed onto the inner wall of the magnetic bead capture chamber 106, and the remaining liquid portion of the mixture will be pushed into the waste liquid chamber 105, and then close the third valve B3 and the sixth valve B6. Continue to puncture the second cleaning solution package 125, open the fifth valve B5, and introduce air through the fifth airflow channel A5 to push the cleaning solution into the sample processing chamber 103, and then close the fifth valve B5. Open the third valve B3 and the sixth valve B6 to introduce air through the sixth air passage A6, pushing the cleaning solution sequentially into the magnetic bead capture chamber 106 and the waste liquid chamber 105, completing the second cleaning of the magnetic beads. Continuously introduce air through the sixth air passage A6 to dry the reagent remaining on the surface of the magnetic beads in the magnetic bead capture chamber 106.

[0173] Step 7: Release the eluent: Puncture the eluent pack 124 to allow the eluent to flow out into the test chamber 132 of the fourth airflow channel A4. At this time, since the corresponding needle valve of the channel is closed, the eluent will temporarily remain in the test chamber 132 and will not automatically flow into the various chambers of the cartridge body 1. Open the seventh valve B7 and the eighth valve B8, and introduce air through the fourth airflow channel A4 to push the eluent sequentially into the magnetic bead capture chamber 106 and the mixing chamber 107. Continuously introduce air through the fourth airflow channel A4, using the bubbles continuously generated from the bottom of the mixing chamber 107 to mix the eluent and the lyophilized beads in the mixing chamber 107. Then close the seventh valve B7 and the eighth valve B8.

[0174] Step 8: Push the elution buffer into the PCR chamber: Open the ninth valve B9 and introduce air through the seventh air passage A7 to push the elution buffer in the mixing chamber 107 into the PCR chamber 109. Since the PCR chamber 109 is equipped with a waterproof and breathable membrane 166, the mixture will stop flowing into the PCR chamber 109 after all four amplification chambers 162 are filled. At this time, close the ninth valve B9.

[0175] Step 9: Isolate the flow of fluid: Using the pressurization module of the instrument, pressurize the first partition M1 and the second partition M2 to isolate the PCR chamber 109 from other channels.

[0176] Step 10: Perform amplification cycle: The four amplification regions 162 of PCR chamber 109 are heated and cooled in cycles using the amplification heating module of the instrument, and the amplification results are detected by the optical detection module.

[0177] Step 11, Sealing the flow channel: After the experiment, use the heating module of the matching instrument to heat the wax in the wax valve chamber (blocking chamber 108), so that the wax melts and falls naturally under the action of gravity. After solidification, it blocks the flow channel between the mixing chamber 107 and the PCR chamber 109, thereby sealing the PCR chamber 109 to prevent the amplification products in the PCR chamber from leaking out of the cartridge through the flow channel and contaminating the instrument or the environment.

[0178] In summary, this invention proposes a cartridge that rationally arranges necessary reaction chambers, such as a sample chamber, a magnetic bead storage chamber 104, a magnetic bead capture chamber 106, a waste liquid chamber 105, a mixing chamber 107, and a PCR chamber 109, on the cartridge body 1. The reagents required for the reaction are independently sealed in reagent packets attached to the cartridge body 1, thus solving the problem of sealed reagent storage. Preferably, thermoplastic elastic adhesive is used as the unpacking component 4 to achieve unpacking of the reagent packets.

[0179] In addition, the cartridge body 1 is rationally designed with airflow channels, main flow channels and valves (specially designed needle valves). The flow direction and stopping position of the sample and reagent are controlled by the valves, and the flow of liquid in the cartridge body 1 is controlled by the air pump driving the liquid, so that the reagent pack and the reaction chamber are selectively connected, and the control is simple and reliable.

[0180] Furthermore, when using an air pump to control the liquid within the cartridge, or when the liquid reacts within the reaction chamber, bubbles are easily generated. Existing technologies use horizontally structured cartridges, making it difficult to remove these bubbles generated during the reaction or by the air pump. In contrast, the cartridge of this invention has a vertical structure, allowing bubbles generated during the reaction to rise from the bottom up, making them easily eliminated. Moreover, a waterproof and breathable membrane 166 is provided at the PCR chamber 109, enabling the mixture of eluent and lyophilized beads to be degassed again before entering the PCR chamber 109, ensuring that the mixture entering the PCR chamber 109 is bubble-free.

[0181] Therefore, this invention proposes a cartridge and detection device that integrates molecular diagnostic nucleic acid extraction, amplification, and detection, achieving an automated and closed detection process. Using this device, the detection time is less than one hour, and manual operation takes no more than two minutes. It can be used to detect pathogen genomic targets in a variety of different human clinical samples, demonstrating wide applicability. The device is stored and transported at room temperature, eliminating the need for a cold chain, thus offering high economic efficiency. The cartridge of this invention is fully enclosed during the detection process, and its detection results are completely consistent with conventional methods. Operation is safe and convenient, requiring no professional training.

[0182] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and substitutions can be made without departing from the technical principles of the present invention, and these improvements and substitutions should also be considered within the scope of protection of the present invention.

Claims

1. A card holder, characterized in that, The card box is used to vertically insert the matching instrument and includes the card box body (1), reagent pack group (2) and cap (3). The cartridge body (1) is provided with a main channel, a valve group, a reaction chamber and an airflow channel; the valve group includes several valves located at predetermined positions in the main channel, so that one end of the reaction chamber and the airflow channel can be selectively connected to the main channel, and the other end of the airflow channel has an air vent for connecting an air pump; The reaction chamber includes a sample chamber, a magnetic bead storage chamber (104), a magnetic bead capture chamber (106), a waste liquid chamber (105), a mixing chamber (107), and a PCR chamber (109); the sample chamber is connected to the first end of the magnetic bead storage chamber (104) and the magnetic bead capture chamber (106), respectively; the first end of the magnetic bead capture chamber (106) is also connected to the mixing chamber (107), and its opposite second end is connected to the waste liquid chamber (105); the mixing chamber (107) is connected to the PCR chamber (109); the sample chamber has a sample dispensing port (111), and the cap (3) is used to seal the sample dispensing port (111). The reagent pack group (2) is affixed to the surface of the card box body (1), and the reagent pack group (2) includes at least four independently sealed reagent pack units; The airflow channels include at least a first airflow channel (A1), a second airflow channel (A2), a third airflow channel (A3), and a fourth airflow channel (A4) corresponding to the four reagent pack units, respectively; after the reagent pack unit is broken, the test solution inside flows into the first airflow channel (A1), the second airflow channel (A2), the third airflow channel (A3), and the fourth airflow channel (A4), and flows into one or more of the reaction chambers along the main flow channel under the control of the valve group and the air pump; The PCR chamber (109) includes a central chamber (161), an amplification chamber (162), a regional flow channel (163), a central flow channel groove (164), a gas-containing area (165), a waterproof and breathable membrane (166), and a regional air channel (167). The central flow channel (164) is located on the front side of the central cavity (161), and the main flow channel is located on the back side of the central cavity (161). The main flow channel is connected to one end of the central flow channel (164), and the other end of the central flow channel (164) is connected to the amplification cavity (162) through the zone flow channel (163). The waterproof and breathable membrane (166) is attached to the central cavity (161) to seal the central flow channel (164). One end of the zone air channel (167) is located at the edge of the sealed area of ​​the waterproof and breathable membrane (166), and the other end is connected to the air-containing zone (165). Each amplification chamber is provided with two flow channels, namely an inlet flow channel and an outlet flow channel; one end of the inlet flow channel is connected to the central flow channel groove, and the other end of the inlet flow channel is connected to one end of the amplification chamber; one end of the outlet flow channel is connected to the other end of the amplification chamber, and the port of the other end of the outlet flow channel is located in the central chamber and is sealed by the waterproof and breathable membrane; The inlet flow channel is provided with a first barrier, and the outlet flow channel is provided with a second barrier; The valve includes a valve cavity (151), an elastic pad (152), and at least one protrusion (153). The valve cavity (151) has a first flow channel hole (154) on its side and a second flow channel hole (155) on its bottom; the elastic pad (152) is located above the second flow channel hole (155); the protrusion (153) is provided on the surface of the elastic pad (152) facing the valve cavity (151), and / or is provided on the surface of the valve cavity (151) at a position corresponding to the elastic pad (152), so that there is a gap between the elastic pad (152) and the second flow channel hole (155).

2. The card holder according to claim 1, characterized in that, The four reagent pack units are respectively the lysis buffer pack (121), the binding buffer pack (122), the first washing buffer pack (123), and the elution buffer pack (124) corresponding to the first gas flow channel (A1), the second gas flow channel (A2), the third gas flow channel (A3), and the fourth gas flow channel (A4). The first airflow channel (A1) is connected to the magnetic bead storage cavity (104), the second airflow channel (A2) is connected to the sample cavity, the third airflow channel (A3) is connected to the first end of the sample cavity or the magnetic bead capturing cavity (106), and the fourth airflow channel (A4) is connected to the second end of the magnetic bead capturing cavity (106).

3. The card holder according to claim 2, characterized in that, The reagent pack group (2) also includes a second cleaning solution pack (125), and the airflow channel also includes a fifth airflow channel (A5) corresponding to the second cleaning solution pack (125). The fifth airflow channel (A5) is connected to the first end of the sample chamber or the magnetic bead capture chamber (106).

4. The card holder according to claim 1, characterized in that, The card box body (1) is also provided with a sixth air channel (A6), a seventh air channel (A7) and an eighth air channel (A8); one end of the sixth air channel (A6), the seventh air channel (A7) and the eighth air channel (A8) are all connected to the air pump through the air inlet, the other end of the sixth air channel (A6) is connected to the top of the sample chamber, the other end of the seventh air channel (A7) is connected to the mixing chamber (107) and the other end of the eighth air channel (A8) is connected to the waste liquid chamber (105).

5. The card holder according to claim 1, characterized in that, The sample chamber includes a sample addition chamber (101), an internal reference lyophilized bead chamber (102), and a sample processing chamber (103). The sample addition chamber (101) and the sample processing chamber (103) are connected by a siphon bend (110). One end of the internal reference lyophilized bead chamber (102) is connected to the bottom of the sample addition chamber (101), and the other end is connected to one end of the siphon bend (110). The other end of the siphon bend (110) is connected to the top of the sample processing chamber (103). The sample dispensing port (111) is located at the top of the sample addition chamber (101).

6. The card holder according to claim 1, characterized in that, The reaction chamber further includes a blocking chamber (108); the blocking chamber (108) is connected to the main channel between the mixing chamber (107) and the PCR chamber (109) to block the connection between the mixing chamber (107) and the PCR chamber (109) when a preset condition is met.

7. The card holder according to claim 1, characterized in that, The card box body (1) includes a card box plate (11), a front film (12) and a rear film (13); the front of the card box plate (11) is provided with a cavity or through hole, the front film (12) is attached to the front of the card box plate (11), and the rear film (13) is attached to the back of the card box plate (11) to seal the cavity or through hole, thereby forming the reaction chamber.

8. The card holder according to claim 7, characterized in that, The main channel is composed of at least one positive and negative groove structure; the positive and negative groove structure includes a positive groove (N1), a back groove (N2) and a connecting hole (N3); the positive groove (N1) is located on the front side of the card holder plate (11), the back groove (N2) is located on the back side of the card holder plate (11), and the connecting hole (N3) connects the positive groove (N1) and the back groove (N2); the front membrane (12) and the rear membrane (13) seal the positive groove (N1), the back groove (N2) and the connecting hole (N3) to form the main channel.

9. The card holder according to claim 1, characterized in that, The second flow channel hole (155) is located at the center of the valve cavity (151); a protrusion (153) is provided, the protrusion (153) is provided on the surface of the valve cavity (151), and is located on the line connecting the first flow channel hole (154) and the second flow channel hole (155).

10. The card holder according to claim 9, characterized in that, The first flow channel hole (154) is located on the upper part of the side of the valve cavity (151), and the corresponding lower part slopes downward from the outside to the inside.

11. The card holder according to claim 1, characterized in that, The reagent kit assembly includes a shell (21), a sealing film (22), and an attachment (23); The housing (21) is provided with at least four liquid-containing cavities with openings facing the front. The liquid-containing cavities are pre-filled with corresponding test solutions. The sealing film (22) is attached to the front of the housing (21) to seal the liquid-containing cavities, thereby forming a corresponding reagent package unit. One side of the attachment (23) is used to connect to the front of the housing (21), and the other side is used to connect to the surface of the card plate (11). A hollow is formed on the attachment (23) at the position corresponding to the liquid-containing cavity.

12. The card holder according to claim 11, characterized in that, The first airflow channel (A1), the second airflow channel (A2), the third airflow channel (A3), and the fourth airflow channel (A4) each include an upper airflow channel (131), a test liquid chamber (132), and a lower flow channel (133); one end of the upper airflow channel (131) has the air inlet, and the other end is connected to the upper part of the test liquid chamber (132); one end of the lower flow channel (133) is connected to the lower part of the test liquid chamber (132), and the other end is connected to the main flow channel; the test liquid chamber (132) corresponds to the liquid-containing chamber, and after the reagent pack unit is broken, the test liquid inside it flows into the test liquid chamber (132) and the lower flow channel (133) in sequence.

13. The card holder according to claim 12, characterized in that, It also includes a packaging breaker (4); the packaging breaker (4) is a thermoplastic elastic rubber; The edge of the test liquid cavity (132) is provided with an injection groove (134), and the middle part of the test liquid cavity (132) is provided with a partition strip (135) to divide the test liquid cavity (132) into an upper cavity and a lower cavity that are interconnected. The surface of the partition strip (135) is provided with a partition injection groove (136) that is connected to the injection groove (134). All the injection grooves (134) and the partition injection grooves (136) of the test liquid cavity (132) are interconnected to form an injection flow channel. The thermoplastic elastic material is formed into the thermoplastic elastic rubber in the injection flow channel.

14. The card holder according to claim 1, characterized in that, The cap (3) includes a template (31) and a plug (32); The sample loading plate (31) has a sample loading port (111) and a first fixing part (311); the sample loading plate (31) is located at the top of the sample cavity; The plug (32) includes a base plate (321), a plunger (322), and a second fixing part (323); one end of the plunger (322) is disposed on the bottom surface of the base plate (321), and the other end is used to insert into the sample dispensing port (111) to seal the sample dispensing port (111); One end of the second fixing part (323) is connected to the side of the substrate (321) via a bendable member (324), and the other end is connected to the first fixing part (311).

15. A detection device, characterized in that, Includes a card holder and supporting instrument as described in any one of claims 1-14, wherein the supporting instrument includes an air pump communicating with each air vent, and the supporting instrument is provided with a slot for vertically inserting the card holder into the supporting instrument.

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