Detection card cassette

Abstract

The application relates to a detection cartridge, which comprises a first cover, a second cover, a plurality of groove bodies, a plurality of fluid channels and a rotary valve; the second cover has two opposite surfaces, a plurality of first through holes and a plurality of second through holes are arranged on the second cover and respectively penetrate the two surfaces, and the first cover is attached to the second cover; the plurality of groove bodies are clamped between the first cover and the second cover, and each groove body corresponds to and fills each first through hole; the plurality of fluid channels are arranged on the first cover and are respectively connected to a suction pipe; the rotary valve is rotatably arranged between the first cover and the second cover and corresponds to the second through hole, and a flow channel is arranged on the rotary valve to be connected to the groove bodies. The detection cartridge can provide a full-automatic detection process from sample input to detection result output, improve the use limitation and defects of a conventional laboratory, and further improve the detection efficiency and sensitivity.

Description

TECHNICAL FIELD

[0001] The present application relates to a detection cartridge, and in particular to a detection cartridge that can be used for nucleic acid extraction and nucleic acid amplification. BACKGROUND

[0002] Nucleic acid extraction and nucleic acid amplification are common techniques in biomedical detection or diagnosis, which are usually performed in an open conventional laboratory using nucleic acid extraction kits or reagents to extract nucleic acids, and then using nucleic acid amplification kits or reagents to amplify specific nucleic acid fragments or detect specific nucleic acid fragments in the open conventional laboratory. However, the aforementioned kits or reagents require manual operation of nucleic acid extraction and nucleic acid amplification, which is tedious and prone to contamination of the samples or reagents, and is not conducive to mass screening or in-line screening.

[0003] Therefore, there is an urgent need in the industry for novel and advanced nucleic acid extraction and nucleic acid amplification kits, reagents or devices to overcome the shortcomings of the prior art. SUMMARY

[0004] An object of the present application is to provide a detection cartridge that can control the connection between the rotary valve and each groove by rotating the rotary valve in the detection cartridge by a specific angle, thereby allowing various fluids such as samples, reagents and reaction solutions to be freely transferred and mixed between each groove, and the flow rate of the fluids to be precisely controlled to facilitate the performance of each reaction step. Thus, the detection cartridge of the present application can provide a fully automated sample-in result-out detection process, improve the use limitations and shortcomings of conventional laboratories, and thereby improve the detection efficiency and sensitivity.

[0005] In addition, the composite function detection cartridge of the present application also uses magnetic beads to extract nucleic acids, and improves the structure of the grooves and the straws to improve the efficiency of extracting, discharging or transferring the magnetic beads, thereby improving the extraction efficiency and purity. At the same time, the present application effectively reduces the assembly difficulty of multiple detailed components and simplifies the packaging process of the overall detection cartridge, effectively improving the yield and application convenience. Therefore, the novel detection cartridge of the present application can meet the use requirements of biomedical detection or diagnosis products.

[0006] To achieve the above object, a preferred embodiment of the present application provides a detection cartridge, comprising a first cover, a second cover, a plurality of groove bodies, a plurality of fluid channels, and a rotary valve; the second cover has two opposite surfaces, and a plurality of first through holes and second through holes are disposed on the second cover and respectively penetrate the two surfaces, wherein the first cover is attached to the second cover; a plurality of groove bodies are clamped between the first cover and the second cover, and each groove body corresponds to and fills each first through hole; a plurality of fluid channels are disposed in the first cover and respectively connected to a first suction tube; the rotary valve is rotatably disposed between the first cover and the second cover, and corresponds to the second through hole, and a flow channel is disposed on the rotary valve to respectively connect the groove bodies. BRIEF DESCRIPTION OF DRAWINGS

[0007] The following drawings are merely intended to schematically illustrate and explain the present application and do not limit the scope of the present application. Among them:

[0008] Figures 1 to 6 A schematic diagram of a detection cartridge in a first embodiment of the present application is shown, wherein;

[0009] Figure 1 A perspective exploded view of the detection cartridge in the first embodiment of the present application is shown;

[0010] Figure 2 A top view of the detection cartridge in the first embodiment of the present application is shown;

[0011] Figure 3 A cross-sectional view of the groove body of the detection cartridge in the first embodiment of the present application is shown;

[0012] Figure 4 A perspective view of the rotary valve of the detection cartridge in the first embodiment of the present application is shown;

[0013] Figure 5 A cross-sectional view of the suction tube of the detection cartridge in the first embodiment of the present application is shown; and

[0014] Figure 6 A cross-sectional view of the short pulse laser rupturing cells in the fluid channel of the detection cartridge in the first embodiment of the present application is shown.

[0015] Figures 7 to 10 A schematic diagram of a detection cartridge in a second embodiment of the present application is shown, wherein;

[0016] Figure 7 A perspective exploded view of the detection cartridge in the second embodiment of the present application is shown;

[0017] Figure 8 A top view of the detection cartridge in the second embodiment of the present application is shown;

[0018] Figure 9FIG. 1 is a perspective view of a rotary valve for detecting a cartridge in a first embodiment of the present application.

[0019] Figure 10 FIG. 2 is a partial cross-sectional view of a rotary valve for detecting a cartridge and a suction tube in a second embodiment of the present application.

[0020] BRIEF DESCRIPTION OF DRAWINGS

[0021] 100, 400: first cover

[0022] 100a: first surface

[0023] 100b: second surface

[0024] 101, 401: fluid passage

[0025] 102, 402: suction tube

[0026] 102a, 104a: inclined side wall

[0027] 103, 403: gas passage

[0028] 104, 404: gas hole

[0029] 106, 406: vent hole

[0030] 110, 410: second cover

[0031] 110a: first surface

[0032] 110b: second surface

[0033] 111, 113, 115, 117, 411, 413: through hole

[0034] 130, 470: rotary valve

[0035] 131, 471: first portion

[0036] 133, 473: second portion

[0037] 133a, 473a: clasp portion

[0038] 135, 475: flow passage

[0039] 137, 477: protrusion

[0040] 137a, 477a: opening

[0041] 150, 450: tank

[0042] 151: tank / reagent tank

[0043] 152, 452: film-like substance

[0044] 153: tank / reaction tank

[0045] 154: body

[0046] 154a: inclined portion

[0047] 154b, 154c: inclined wall surface

[0048] 155: tank / sample tank

[0049] 157: tank / extraction tank

[0050] 160, 460: accommodation space

[0051] 170: liquid temporary storage area

[0052] 180, 480: sealing film

[0053] 200, 200': fluid

[0054] 210: laser diode

[0055] 211: short pulse laser

[0056] 212: optical lens set

[0057] 212a: light collecting lens

[0058] 212b: light converging lens

[0059] 213: focal point

[0060] 220: cell

[0061] 405: air guide channel

[0062] 430: third cover

[0063] 431: base

[0064] 433: straw

[0065] 451: reagent tank

[0066] 453: reaction tank

[0067] 455: sample tank

[0068] 457: extraction tank

[0069] 472: vertical flow channel

[0070] 479: protruding ring

[0071] 479a: air hole

[0072] 300, 500: detection cartridge

[0073] D1, D2: direction DETAILED DESCRIPTION

[0074] In order to enable any person skilled in the art to better appreciate and understand the present application, various preferred embodiments of the present application are described hereinafter in detail with reference to the drawings, in which:

[0075] In the present application, the description of "a first component is formed on or above a second component" can mean that the first component is in direct contact with the second component, or can mean that there is another component between the first component and the second component, so that the first component is not in direct contact with the second component. In addition, various embodiments of the present application can use repeated component symbols and / or textual annotations. The use of these repeated component symbols and textual annotations is to make the description more concise and clear, rather than to indicate the relevance between different embodiments and / or configurations. In addition, for the spatial-related descriptive words mentioned in the present application, such as "under", "above", "low", "high", "below", "above", "below", "above", "bottom", "top" and the like, for the sake of description, their use is to describe the relative relationship between one component or feature and another (or multiple) component or feature in the drawings. In addition to the orientation shown in the drawings, these spatially related words are also used to describe the possible orientation of the components during the manufacturing process, in use, and in operation. For example, when the component is rotated by 180 degrees, a component originally disposed "above" another component will become disposed "below" the other component. Therefore, as the orientation of the component changes (rotated by 90 degrees or other orientations), the spatially related description used to describe its orientation should also be interpreted accordingly.

[0076] Although the present application uses the words first, second, third, etc. to describe various components, parts, regions, layers and / or sections, it should be understood that such components, parts, regions, layers and / or sections should not be limited by such words. Such words are only used to distinguish one component, part, region, layer and / or section from another component, part, region, layer and / or section, and do not imply or represent that the component has any previous ordinal number, nor represent the arrangement order of one component and another component, or the order of the manufacturing method. Therefore, without departing from the scope of the embodiments of the present application, the first component, part, region, layer or section discussed below can also be referred to as the second component, part, region, layer or section.

[0077] The terms "about" or "substantially" as used in this invention generally mean within 20% of a given value or range, preferably within 10%, and even more preferably within 5%, or within 3%, or within 2%, or within 1%, or within 0.5%. It should be noted that the quantities provided in the specification are approximate quantities; that is, the meaning of "about" or "substantially" may be implied even without specific mention of it.

[0078] Please refer to Figures 1 to 6 As shown, it illustrates a schematic diagram of the detection cartridge 300 in the first embodiment of the present invention, wherein, Figure 1 To examine the exploded 3D view of cartridge 300, Figure 2 A top view diagram of the cassette 300 for testing. Figure 6 The first figure is an operational schematic diagram of the card cartridge 300; the other figures are perspective or cross-sectional schematic diagrams of the detailed components of the card cartridge 300. Figure 1 as well as Figure 2 As shown, the detection cartridge 300 includes a first cover 100, a second cover 110, and a rotary valve 130. The first cover 100, for example, has two opposing surfaces, such as... Figure 1 The first surface 100a and the second surface 100b are shown, and the second cover 110 also has two opposing surfaces, such as... Figure 1 The first surface 110a and the second surface 110b are shown. The second surface 100b of the first cover 100 is arranged face-to-face with the first surface 110a of the second cover 110. When the detection cartridge 300 is not assembled, the second cover 110 and the first cover 100 are separated from each other and may have an accommodating space 160 therebetween (e.g., ...). Figure 1 As shown), the rotary valve 130, multiple slots 150, and other components can be accommodated within the accommodating space 160. During the assembly of the detection cartridge 300, the second surface 100b of the first cover 100 and the first surface 110a of the second cover 110 are abutted against each other, thereby sandwiching the rotary valve 130 and slots 150 between the second cover 110 and the first cover 100 (as shown). Figure 2 (as shown), thus eliminating the accommodating space 160. In one embodiment, the first cover 100 and the second cover 110 are assembled, for example, by a heat-sealing method or an ultrasonic method, to improve the reliability and ductility of the detection cartridge 300, but are not limited thereto.

[0079] The first cover 100 and the second cover 110 each include, for example, a piece along a horizontal direction (e.g., the x-direction, as shown in the image). Figure 1The flat plate shown in the direction D1) is made of, for example, a plastic injection molding and includes a suitable material selected from the group consisting of polypropylene (PP), polycarbonate (PC), polyimide (PI), polyethylene terephthalate (PET), and other thermoplastic and biocompatible materials, but not limited thereto. In addition, the first cover 100 and the second cover 110 can have corresponding shapes, for example, both have a rectangular shape, such as Figure 1 The specific shapes of the first cover 100 and the second cover 110 in the embodiment are only illustrative, and the first cover 100 and the second cover 110 can also have other suitable shapes according to actual product requirements. Figure 1 The specific shapes of the first cover 100 and the second cover 110 in the embodiment are only illustrative, and the first cover 100 and the second cover 110 can also have other suitable shapes according to actual product requirements.

[0080] Specifically, the first surface 100a of the first cover 100 is specifically provided with a plurality of fluid channels 101 and a plurality of gas channels 103. In the embodiment, each fluid channel 101 and each gas channel 103, for example, respectively extends transversely along any direction parallel to the direction D1, and is connected with a suction tube 102 or a gas hole 104 for fluid or gas flow. Among them, each gas channel 103 is connected with the gas hole 104 at one end and the gas vent hole 106 provided on the first cover 100 at the other end for exhaust. Please refer to Figure 3 As shown, each suction tube 102 and each gas hole 104 is a hollow structure extending downward from the first surface 100a of the first cover 100 and protruding outside the second surface 100b of the first cover 100. In an embodiment, the bottom of the suction tube 102 and the gas hole 104 preferably has an inclined side wall 102a, 104a, such as Figure 3 As shown, but not limited thereto. The inclined side wall 102a of the suction tube 102 can improve the problem of liquid residue when the suction tube 102 sucks liquid and facilitate piercing the sealing film during assembly. In another embodiment, the suction tube and the gas hole can also be selected to have no inclined side wall (not shown). In addition, according to actual product requirements, the fluid channels and / or the gas channels can also have different extension directions, for example, respectively extend along any direction perpendicular to the direction D1 (such as the direction D2), or have different setting positions, etc., without being limited to the above-mentioned style.

[0081] The second cover 110 is further provided with a plurality of through holes 111, 113, 115, respectively penetrating the first surface 110a and the second surface 110b. Among them, each through hole 111, 113, 115, for example, has different sizes (for example, refers to the hole diameter of the through hole 111, 113, 115 is different) and can accommodate a plurality of grooves 150 of different sizes, for example,Figure 1 as well as Figure 2 The grooves shown are 151, 153, and 155, but are not limited to these. In other words, the dimensions of each of the aforementioned through holes may differ depending on the dimensions of each groove, and the dimensions of each groove can be selected according to actual product requirements, and are not limited to these dimensions. Figure 1 as well as Figure 2 The description is limited to what is shown here, and this should be readily understood in this field. Please refer to the following references as well. Figure 3 As shown, each tank 150 includes, for example, a hollow body 154 to accommodate various reagents according to product requirements, and is then sealed by a membrane (e.g., containing aluminum foil, plastic, etc.) 152. Preferably, the body 154 may have an inclined portion 154a to facilitate the concentration of various reagents contained within the tank 150, wherein the inclined portion 154a may have an inclined wall surface 154b, for example, at least located at the bottom of the body 154. Figure 3 As shown, but not limited thereto. In another embodiment, the body 154 may also be configured to have an inclined wall 154c throughout, as shown. Figure 5 As shown.

[0082] In one embodiment, the tank 150 includes, for example, a plurality of reagent tanks 151, at least one reaction tank 153, and at least one sample tank 155. Each reagent tank 151 can contain washing solution, buffer solution, elution solution, or lysis solution, etc. The at least one reaction tank 153 can contain various enzymes or reactants to be reacted, such as primer pairs and / or probes, etc., while the at least one sample tank 155 can contain various samples such as bacteria, cells, or viruses, or samples suspected of containing bacteria, cells, or viruses, awaiting confirmation by nucleic acid extraction and nucleic acid amplification procedures. The reaction tanks 153 can have any suitable number, for example, as shown in the figure. Figure 1 As shown in the two examples, the detection cartridge 300 can simultaneously perform various amplification and detection reactions in two reaction cells 153, depending on the various primer pairs and / or probes contained therein, but is not limited thereto. Those skilled in the art will readily understand that in other embodiments, the detection cartridge may also contain a single reaction cell, or a greater number of reaction cells, to meet different detection requirements. Furthermore, the cell 150 may also include an extraction cell 157, which may contain multiple magnetic beads (not shown) that can bind to the sample to be tested at the start of the detection experiment for purification.

[0083] It is noted that the suction pipe 102 and the air hole 104 disposed on the first cover 100 are opposite to the through holes 111, 113, 115 disposed on the second cover 110. Thus, after the detection cassette 300 is assembled, the suction pipe 102 and the air hole 104 disposed on the first cover 100 can pierce the film 152 of each slot 150 accommodated in each through hole 111, 113, 115 through the inclined side walls 102a, 104a thereof, as shown in Figure 3 Preferably, after the suction pipe 102 and the air hole 104 on the first cover 100 pierce the slot 150, the suction pipe 102 can extend to the bottom of the slot 150, more preferably to a position close to the inclined portion 154a, and the air hole 104 can be located at the top of the slot 150, at a position just piercing the film 152, as shown in Figure 3 but not limited thereto.

[0084] On the other hand, the second cover 110 is further provided with a through hole 117 for rotatably accommodating the rotary valve 130 in the through hole 117. In detail, the rotary valve 130 is composed of a soft material combined with a hard material, so as to improve the air tightness of the rotary valve 130 combined with the first cover 100 and the second cover 110. Please refer to Figure 4 The rotary valve 130 includes a first portion 131 and a second portion 133 stacked in sequence from top to bottom, wherein the first portion 131 is composed of thermoplastic polyurethanes (TPU), rubber, polyurethane material, polyethylene, polyethylene terephthalate (PET), thermoplastic polyester elastomer (TPEE), biocompatible resin or a combination thereof, and the second portion 133 is composed of a material different from the first portion 131 and more rigid, such as polypropylene fiber, polycarbonate, etc., but not limited thereto. Thus, when the detection cassette 300 is assembled, the first portion 131 of the rotary valve 130 can be attached to the second surface 100b of the first cover 100, and the second portion 133 of the rotary valve 130 can be installed in the through hole 117, so as to achieve a tightly attached assembly state.

[0085] In this embodiment, the first portion 131 of the rotary valve 130 specifically includes a protrusion 137, and a flow channel 135 and an opening 137a are formed around the protrusion 137. The second portion 133 of the rotary valve 130 includes a latching portion 133a. The flow channel 135 can have any suitable shape, for example... Figure 4 The linear shape shown is not a limitation. Thus, after the detection cartridge 300 is assembled, the second part 133 (including the latching part 133a) of the rotary valve 130 protrudes into the through hole 117 on the second cover 110. A motor (not shown) is further connected externally via the latching part 133a, and this motor drives and controls the rotation of the rotary valve 130 inside the detection cartridge 300. In other words, the rotary valve 130 is rotatably disposed between the first cover 100 and the second cover 110. With this arrangement, the rotation of the rotary valve 130 allows one end of the flow channel 135 to be sequentially connected to different fluid channels 101. Simultaneously, the opening 137a can be aligned with the vent 104. When the rotary valve 130 is further connected to a pump (not shown) via the liquid storage area 170, the pump can provide positive and negative pressure to draw out, discharge into, or transfer various reagents from each tank 150 to other tanks 150. In this embodiment, the detection cartridge 300 is further provided with a liquid temporary storage area 170, for example, which is provided on the first surface 100a of the first cover 100. Figure 1 as well as Figure 2 As shown, the liquid storage area 170 is, for example, a serpentine or continuously curved hollow tubular structure, one end of which can be connected to the other end of the flow channel 135, while the other end of the liquid storage area 170 can be provided with a pump interface 173 for connecting an external pump. In this way, the detection cartridge 300 can temporarily store the aspirated reagent in the liquid storage area 170, thereby assisting in reagent aspiration, discharge, or transfer.

[0086] In addition, the detection cartridge 300 may also include a planar membrane material (e.g., a film-like material). Figure 1 The sealing film 180 shown is attached to the first surface 100a of the first cover 100 to seal multiple fluid channels 101, multiple gas channels 103 and liquid storage area 170 as a closed channel.

[0087] In a preferred embodiment, the detection cartridge 300 can be used for nucleic acid extraction and nucleic acid amplification, but is not limited thereto. For example, by rotating the rotary valve 130 at a specific angle, the sample in the sample slot 155 can be transferred to one of the reagent slots 151 to chemically rupture or open the cells in the sample. Then, rotating the rotary valve 130 transfers the sample containing the ruptured or opened cells and their released substances to the extraction slot 157 for purification by binding with magnetic beads in the extraction slot 157. The sample bound to these magnetic beads is then sequentially transferred to other reagent slots 151 for washing. Finally, the required biological material (such as nucleic acid) is eluted from these magnetic beads for subsequent detection reactions. Then, the biological material is transferred to the reaction tank 153 using the rotary valve 130 for the required detection reaction. If the reaction tank 153 is pre-contained with freeze-dried primer pairs, nitrogenous bases, and nucleic acid polymerase, polymerase chain reaction can be performed after the biological material is injected into the reaction tank 153, but this is not a limitation. In another embodiment, other enzymes or reagents may be pre-placed in the reaction tank 153 to perform other detection reactions, such as probe binding reactions or enzyme binding reactions, to meet product requirements. It should be noted that when transferring the aforementioned samples or biological materials, the length of the pipette 102 extending into each tank 150 can be used for quantitative fluid measurement. For details, please refer to... Figure 5 As shown, a fluid (such as the aforementioned sample or biological material) 200 is injected into the tank 150. Its initial liquid level can completely cover the pipette 102 to a specific height (as shown in the left figure). Then, when the fluid 200 is drawn out, because the liquid level of the fluid 200 decreases, the bottom of the pipette 102 is no longer covered by the fluid 200, leaving only the fluid 200' (as shown in the right figure). In this way, the volume of the drawn-out fluid 200 can be accurately controlled, and the volume of the remaining fluid 200' in the tank 150 can be used for secondary confirmation. In other words, the specific liquid level height depends on the volume of the required fluid 200. When the volume of the fluid 200 to be drawn is large, a pipette 102 that extends deeper into the tank 150 can be used, or a tank 150 with a shorter height can be selected. Conversely, when the volume of the fluid 200 to be drawn is small, a pipette 102 that extends into the tank 150 to a shallower depth can be used, such as only half the depth of the tank 150 or reaching near the top of the tank 150, or a tank 150 with a larger height can be selected. In this way, the depth of the pipette 102 extending into each tank 150 can be adjusted according to the actual needs of the test, thereby quantifying the amount of fluid to be transferred.

[0088] Furthermore, it should be noted that when the rotary valve 130 transfers the biological material to the reaction tank 153, the rotary valve 130 can be rotated first so that its flow channel 135 aligns with the pipette 102 extending into the reaction tank 153. At this time, the opening 137a of the rotary valve 130 can align with the vent 104 extending into the reaction tank 153. In this way, the biological material can be smoothly injected into the reaction tank 153 with the gas channel 103 unobstructed. However, when the reaction tank 153 needs to perform a detection reaction, the rotary valve 130 can be rotated again so that the pipette 102 and the vent 104 extending into the reaction tank 153 are no longer aligned with the flow channel 135 and the opening 137a, thus closing the fluid channel 102 and the gas channel 103. This prevents the volume of reactants and fluids in the reaction tank 153 from evaporating due to temperature rise or condensing due to temperature drop, which would affect the concentration of reactants and fluids. In other words, when the reaction tank 153 is conducting a detection reaction, the protrusion 137 provided on the rotary valve 130 can be used to cover the suction tube 102 and the air hole 104 inside the reaction tank 153, so that the inside of the reaction tank 153 can reach a sealed state, which is conducive to the detection reaction.

[0089] Therefore, in a preferred embodiment, for nucleic acid extraction and amplification, the rotary valve 130 is rotated to connect the flow channel 135 to the liquid storage area 170 and the sample tank 155 via the fluid channel 101; the pump is driven to aspirate the sample from the sample tank 155 to the liquid storage area 170. Then, the rotary valve 130 is rotated to connect the flow channel 135 to the reagent tank 151 via the fluid channel 101. Figure 2 (Top right corner) The other end of the flow channel 135 remains connected to the liquid storage area 170; the pump is driven to repeatedly pump the sample in and out of the liquid storage area 170 between the reagent tank 151 and the liquid storage area 170. The cells (or suspected cells) in the sample are ruptured or opened by the lysis solution in the reagent tank 151 and the physical force of the flow between the fluid channel 101, the flow channel 135 and the liquid storage area 170, so that the sample and the lysis solution are mixed into a first mixture. Next, the rotary valve 130 is rotated to connect the flow channel 135 to the extraction tank 157 via the fluid channel 101. The first mixture temporarily stored in the liquid storage area 170 is discharged into the extraction tank 157 through the flow channel 135 and the fluid channel 101. The extraction tank 157 contains magnetic beads with surfaces that can bond to nucleic acids. These magnetic beads capture nucleic acids (if any) in the first mixture to form a nucleic acid-magnetic bead complex, or the magnetic beads do not capture nucleic acids (if the nucleic acids are not present in the sample). Similarly, through the suction and discharge of the pump, the magnetic beads are thoroughly mixed with the first mixture to form a second mixture.

[0090] Next, a magnet or magnetic device (not shown) placed outside the extraction tank 157 can be brought close to the extraction tank 157 to adsorb the nucleic acid-magnetic bead complex (or only the magnetic beads, if the nucleic acid is not present) in the second mixture. The remaining portion of the second mixture is aspirated and transferred to the liquid storage area 170, and the rotary valve 130 is then rotated to connect the used reagent tank 151. Figure 2 (Top right corner) The remaining portion is then transferred from the liquid storage area 170 to the used reagent tank 151 for storage. Preferably, the magnet or magnetic device is positioned away from the inclined sidewall 102a of the pipette 102 to prevent the desired nucleic acid-magnetic bead complex from being drawn out of the extraction tank 157 and discarded due to the pump suction.

[0091] Then, the rotary valve 130 is rotated to connect to another reagent tank 151 containing cleaning solution. Figure 2 The reagent tank 151 below the rotary valve 130, with the magnet or magnetic device moved away from the extraction tank 157, first transfers the washing solution to the liquid storage area 170 and then to the extraction tank 157, rinsing off the nucleic acid-magnetic bead complex, which forms a third mixture with the washing solution. The magnet or magnetic device is then brought closer again to adsorb the nucleic acid-magnetic bead complex, and in this manner, the remainder of the third mixture is transferred to the reagent tank 151. Figure 2 (Top right corner) Store.

[0092] When using a buffer solution, the nucleic acid-magnetic bead complex is treated in the same manner as before. Those skilled in the art will readily understand that in other embodiments, the nucleic acid-magnetic bead complex can be treated with the same or different formulations of washing solutions and buffer solutions in one or more reagent tanks 151 to improve extraction efficiency and purity.

[0093] Next, the rotary valve 130 is rotated to connect to another reagent tank 151 containing the eluent. Figure 2The magnet or magnetic device is moved away from the extraction slot 157, and the eluent is first transferred to the liquid storage area 170 and then to the extraction slot 157. The eluent breaks the intermolecular bond between the nucleic acid and the surface of the magnetic beads, and the nucleic acid is released. The magnet or magnetic device is moved close again to adsorb the magnetic beads. The remaining portion of the fourth mixture (containing the nucleic acid and the eluent) is first transferred to the liquid storage area 170, and the rotary valve 130 is rotated to connect the reaction slot 153, the flow channel 135, and the liquid storage area 170. It is worth noting that at this time, the opening 137a formed by the upper half-closed protrusion 137 of the rotary valve 130 is connected to the reaction slot 153 through the gas channel 103 and the gas hole 104. The remaining portion (containing the nucleic acid and the eluent) is injected from the liquid storage area 170 to the reaction slot 153 under the condition that the gas channel 103 is open. When the reaction slot 153 needs to perform a detection reaction, the rotary valve 130 is rotated so that the suction tube 102 and the gas hole 104 that extend into the reaction slot 153 are no longer connected to the flow channel 135 and the opening 137a, and the fluid channel 102 and the gas channel 103 are closed.

[0094] In addition, the detection cassette 300 of the present application can simultaneously perform one or more nucleic acid amplification reactions. An appropriate volume of the remaining portion can be distributed to two or more reaction slots 153. The remaining portion containing the nucleic acid is amplified under the temperature control of an external instrument (not shown) and the presence of primer pairs and / or probes, deoxynucleotide triphosphates, and polymerases. The external instrument detects the signal of the amplified nucleic acid to determine whether the sample contains a specific gene or nucleic acid fragment of a specific bacterium, cell, or virus, and the content thereof.

[0095] In the foregoing embodiment, the cells in the sample are broken or opened by the lysis solution in the reagent slot 151 and the physical force of the reciprocating flow between the flow channels. The sample and the lysis solution form the first mixture, and then the first mixture is mixed with the magnetic beads in the extraction slot to form the nucleic acid-magnetic bead complex. In another modified embodiment, the sample and the lysis solution can be separately sent to the extraction slot 157 to be mixed with the magnetic beads to form the second mixture; or the sample can be added to the lysis solution and immediately transferred to the extraction slot 157 to be mixed with the magnetic beads to form the second mixture. Then, the second mixture is reciprocated between the fluid channel 101, the flow channel 135, and the liquid storage area 170. Not only are the cells in the second mixture broken or opened by the physical force and the lysis solution, but the nucleic acid released from the cells is also captured by the magnetic beads during the mixing process, which greatly reduces the nucleic acid extraction time.

[0096] Thus, this is the detection cartridge 300 in the first embodiment of the present invention. In this embodiment, a rotary valve 130 is rotatably disposed inside the detection cartridge 300, and an external motor drives the rotary valve 130 inside the detection cartridge 300 to rotate freely to any position, thereby allowing various fluids such as samples, reagents, and reaction solutions in the tanks 150 to be freely transferred and mixed between the tanks 150, and finally the detection reaction is carried out in the reaction tank 153. The rotary valve 130 is provided with a flow channel 135 and an opening 137a. When the rotary valve 130 is used to draw fluids such as samples, reagents, and reaction solutions from the tank 150, the flow channel 135 and the opening 137a of the rotary valve 130 are respectively aligned with the suction tube 102 and the air hole 104 located inside the tank 150 to facilitate fluid aspiration. Furthermore, when the tank 150 needs to perform a reaction (including nucleic acid extraction, nucleic acid amplification, cell rupture or opening, etc.), the protrusion 137 of the rotary valve 130 covers the pipette 102 and the vent 104 inserted into the tank 150, ensuring a sealed state within the tank 150. This prevents contamination and facilitates the reaction. With this configuration, the detection cartridge 300 of this embodiment can effectively provide a fully automated detection process for sample entry and result output, improving the limitations and deficiencies of conventional laboratories, thereby increasing detection efficiency and sensitivity.

[0097] Those skilled in the art should also understand that the detection cartridge of the present invention is not limited to the aforementioned style, but may have other styles or variations. For example, in the aforementioned embodiment, since the sample is processed chemically, the detection cartridge 300 may be provided with a reagent slot 151 containing cells that have been broken or opened. However, in other embodiments, cells may be broken in other ways, such as by laser or ultrasound, and the detection cartridge may be further provided with components for breaking cells by laser or ultrasound, and used in conjunction with components such as optical lenses. For example, such as Figure 6 As shown, an additional laser diode 210 can be provided. The short-pulse laser 211 emitted by the laser diode 210 is focused at the focal point 213 by the optical lens group 200 (including the light-receiving lens 212a and the condenser lens 212b). The biological sample cells 220 flowing between the liquid storage area 170, the flow channel 135 of the rotary valve 130, the fluid channel 101, the pipette 102, and the tank 150 can be irradiated by the short-pulse laser 211 when flowing through the focal point 213, causing them to rupture and open, releasing the nucleic acid within the cells 220. However, in another embodiment, the laser diode, the optical lens group, and other optical components can also be installed inside the detection cartridge; or the optical lens group can be installed inside the detection cartridge, and the laser diode can be additionally provided, for example, it can be installed on the instrument (not shown) that houses the cartridge.

[0098] Other embodiments or variations of the detection card cassette of the present application will be described below. For simplicity, the following description will mainly focus on the differences between the embodiments, and the same parts will not be described repeatedly. In addition, the same components in the embodiments of the present application are marked with the same reference numerals for the purpose of mutual comparison between the embodiments.

[0099] Please refer to Figures 7 to 10 , which illustrates a schematic diagram of a detection card cassette 500 in a second embodiment of the present application, wherein, Figure 7 is a perspective exploded view of the detection card cassette 500, Figure 8 is a top view of the detection card cassette 500, and the remaining figures are perspective or sectional schematic diagrams of specific components of the detection card cassette 300. First, as shown in Figure 7 and Figure 8 , the detection card cassette 500 also includes a first cover 400, a second cover 410, a sealing film 480, and a rotary valve 470, and the first cover 400 and the second cover 410 can be separated from each other before assembly to jointly sandwich a containing space 460 therebetween. The structure, material selection, and assembly method of the detection card cassette 500 of the present embodiment are generally the same as those of the detection card cassette 300 of the first embodiment described above, and the same parts will not be described repeatedly. The difference between the present embodiment and the first embodiment described above is that a third cover 430 is additionally provided between the first cover 400 and the second cover 410, and the rotary valve 470 is rotatably arranged on the third cover 430 and located in the containing space 460 between the first cover 400 and the second cover 410. The first cover 400, the third cover 430, and the second cover 410 are assembled, for example, by a heat fusion method or an ultrasonic method, so as to sandwich the rotary valve 470 between the first cover 400 and the third cover 430 (as shown in Figure 8 ), thereby improving the reliability and extendibility of the detection card cassette 500.

[0100] Specifically, the first cover 400 and the second cover 410 can also have corresponding shapes, as shown in Figure 7 and Figure 8The first cover 400 is provided with a plurality of fluid channels 401 and a plurality of gas channels 403, which extend transversely along any direction parallel to the direction D1, for example, and are connected to a suction tube 402 or a gas hole 404 for fluid or gas flow. The second cover 410 is further provided with a plurality of through holes 411 that can penetrate the second cover 410 to accommodate a plurality of groove bodies 450. In this embodiment, the sizes of the groove bodies 450 and the through holes 411 (for example, the diameters or hole diameters of the groove bodies 450 and the through holes 411) are uniform, but the specific arrangement is not limited thereto. In another embodiment, different size selections can be selected with reference to the arrangement of the through holes 111, 113, and 115 and the groove bodies 151, 153, and 155 in the first embodiment described above. The groove bodies 450 include a plurality of reagent grooves 451, at least one reaction groove 453, and at least one sample groove 455, for example. Each reagent groove 451 can contain a washing solution, a buffer solution, an eluent, or a lysis solution, for example. The at least one reaction groove 453 can contain various enzymes or reactants, such as primers or probes, that need to be reacted. The at least one sample groove 455 can contain various samples, such as bacteria, cells, or viruses, or samples suspected of containing bacteria, cells, or viruses, waiting for nucleic acid extraction and nucleic acid amplification procedures. In addition, the groove bodies 450 can include an extraction groove 457, which can further include a plurality of magnetic beads (not shown) that can be combined with the sample to be tested at the beginning of the test to perform purification. In addition, it should be noted that the detailed features of the first cover 400, the second cover 410, and other components (such as the fluid channels 401, the suction tube 402, the gas channels 403, the gas holes 404, the groove bodies 450, and the planar film-like material (not shown) attached to the upper surface of the first cover 400) such as material selection, structure, or arrangement are generally the same as those in the first embodiment described above, and will not be repeated. Figure 7

[0101] The rotary valve 470 of this embodiment can also be composed of a soft material combined with a hard material to improve the air tightness of the rotary valve 470 combined with the first cover 400, the third cover 430, and the second cover 410. Please refer to Figure 9 ​As shown, the rotary valve 470 includes a first part 471 and a second part 473 stacked sequentially from top to bottom. The second part 473 may be made of a material different from the first part 471 and with greater rigidity. The specific material selection is generally the same as that of the first part 131 and the second part 133 in the first embodiment described above, and will not be repeated here. Specifically, the first part 471 includes a protrusion 477, and a flow channel 475 and an opening 477a are formed by surrounding the protrusion 477. The second part 473 of the rotary valve 470 includes a locking part 473a. Thus, when the detection cartridge 500 is assembled, the first part 471 of the rotary valve 470 can be attached to the first cover 400, and the second part 473 of the rotary valve 470 can protrude from the through hole 413, thereby achieving a tight-fitting assembly state. In the aforementioned configuration, the latching portion 473a of the second part 473 of the rotary valve 470 can be further connected to a motor (not shown), which drives and controls the rotary valve 470 in the detection cartridge 500 to rotate.

[0102] The main difference between this embodiment and the previous embodiment is that the coverage area of ​​the rotary valve 470 is larger than that of the rotary valve 130 in the previous embodiment. For example, if by Figure 8 As shown in the top view, the rotary valve 470 partially covers a portion of the groove 450 below it, while the rotary valve 130 in the aforementioned embodiment does not cover any part of the groove 150 (e.g., Figure 2 (As shown). Please refer to the above as well. Figure 7 as well as Figure 10 As shown, the rotary valve 470 is mounted on a base 431 of the third cover 430. The base 431 also partially covers a portion of the groove 450. Furthermore, multiple suction tubes 433 are further disposed below the base 431, which can respectively puncture the respective grooves 450 located below. When the detection cartridge 500 is assembled, each suction tube 433 disposed on the third cover 430 can pierce the membrane 452 of each groove 450 and extend into each groove 450. Specifically, each suction tube 433 is a hollow structure extending downward from the third cover 430 and protruding from a surface of the third cover 430. In this embodiment, although the bottom of each suction tube 433 is shown as a plane (e.g., ...), Figure 10 (as shown), but its specific setting style is not limited to this. In another embodiment, the straw 102 in the above embodiment can also be referred to, and the bottom of these straws is designed with inclined sidewalls to improve the problem of straws being easy to leave residue when sucking liquid.

[0103] On the other hand, because the rotary valve 470 has an expanded coverage area, the flow channel 475 it provides also has a larger volume to accommodate a larger amount of fluid. The flow channel 475 can have any suitable shape, for example... Figure 9The spindle shape is shown, but is not limited thereto. Note that a vertical flow path 472 is also provided on the rotary valve 470, which penetrates the first portion 471 and the second portion 473 of the rotary valve 470 and is connected to the flow path 475, as shown. Figure 9 and Figure 10 In this arrangement, rotation of the rotary valve 470 can sequentially connect the vertical flow path 472 to each of the suction tubes 433, and when the rotary valve 470 is further externally connected to a pump (not shown) via the catch portion 473a, the pump can be used to provide positive or negative pressure to suction, intake or transfer various reagents in the tank 450 to other tanks 450, etc. In addition, in this embodiment, the first portion 471 of the rotary valve 470 is also provided with a protruding ring 479, which surrounds an air hole 479a. When the rotary valve 470 is assisted by the pump to suction, intake or transfer various reagents, the air hole 479a on the rotary valve 470 can be connected to the air hole 406 through the air guide passage 405 additionally provided on the first cover 400, so that various reagents can be smoothly suctioned, intaken or transferred.

[0104] Thus, the detection cartridge 500 in the second embodiment of the present application is obtained. The detection cartridge 500 can also freely transfer and mix various fluids such as samples, reagents and reaction solutions between the tanks 450 by the rotary valve 470 provided therein, and finally perform detection reaction in the reaction tank 453 to effectively provide a fully automated detection process from sample input to detection result output. In this embodiment, the coverage of the rotary valve 470 is expanded so that the rotary valve 470 can partially cover the tanks 450 below, and the flow path 475 of the rotary valve 470 can have a corresponding expanded volume. Thus, when an external motor drives the rotary valve 470 inside the detection cartridge 500 to rotate, the vertical flow path 472 provided on the rotary valve 470 can be directly aligned and connected to the suction tubes 433 penetrating into the tanks 450, and the fluids can be temporarily stored in the flow path 475. In this way, the path of fluid flow can be shortened, and the time required for suction, intake or transfer of fluids can be greatly reduced. In this arrangement, the detection cartridge 500 of this embodiment can also be simplified in component configuration, and not only can the liquid temporary storage area 170 provided in the foregoing embodiment be omitted, but the number of specific arrangements of the fluid passage 401 and / or the gas passage 403 on the first cover 400 can also be significantly reduced. Therefore, the detection cartridge 500 of this embodiment can have more optimized detection efficiency and simpler component configuration compared to the detection cartridge 300 of the foregoing embodiment, and thus can meet the actual needs of detection products.

[0105] In general, the present application provides a detection cartridge, which is formed by two or more cover bodies through heat fusion or ultrasonic wave or the like. The detection cartridge is provided with a rotatable valve, which is connected with an external motor to rotate the valve. The detection cartridge forms a fluid flow path, which includes a groove-fluid channel-rotatable valve flow channel-groove, groove-fluid channel-rotatable valve flow channel-liquid temporary storage area-fluid channel-groove, or groove-rotatable valve vertical flow channel-rotatable valve flow channel-groove. Thus, when the detection cartridge is provided with positive and negative pressure by an external pump, various reagents in the grooves can be smoothly pumped out, pumped in, transferred or mixed, and finally perform a predetermined detection reaction, such as nucleic acid amplification reaction, probe binding reaction or enzyme binding reaction, in a reaction groove, so as to achieve a full-automatic detection process. Those skilled in the art can easily understand that the detection cartridge can be used not only for processing nucleic acid extraction and operating nucleic acid detection reaction, but also for other detection fields according to actual needs. For example, in other embodiments, the detection cartridge of the present application can also be used for extracting protein samples and operating enzyme immunoassay.

[0106] The above description is only the preferred embodiment of the present application, and any equivalent changes and modifications made within the scope of the present application should be included in the scope of the present application.

Claims

1. A detection card cassette, characterized by, The detection card cassette comprises: a first cover; a second cover having two opposite surfaces, the second cover being provided with a plurality of first through holes and a second through hole, the first through holes and the second through hole penetrating the two surfaces respectively; a plurality of grooves clamped between the first cover and the second cover, each groove corresponding to and filling each first through hole; a plurality of fluid channels arranged on the first cover along a horizontal direction and connected to a first suction pipe which can extend into the corresponding groove; a rotary valve rotatably arranged between the first cover and the second cover, corresponding to the second through hole, the rotary valve being provided with a flow channel to communicate each groove, the flow channel constituting a liquid temporary storage area; the rotary valve partially covers each groove below it in a vertical direction; wherein the rotary valve comprises a first part and a second part, the first part comprising a protruding part surrounding the flow channel and an opening; the rotary valve is further provided with a vertical flow channel penetrating the first part and the second part and communicating the flow channel; a third cover clamped between the first cover and the second cover, and the rotary valve is arranged on the third cover; a plurality of second suction pipes are arranged on the third cover, the second suction pipes corresponding to the corresponding first through holes to correspond to the corresponding grooves arranged below them; through the rotation of the rotary valve, the flow channel can also communicate with the corresponding second suction pipe through the vertical flow channel to communicate with the corresponding groove; the first part is further provided with a protruding ring surrounding an internal air hole connected to the air hole through a gas guide channel arranged on the first cover to facilitate the suction, suction or transfer of various reagents; and a plurality of gas channels, each gas channel arranged on the first cover and connected to an air hole; through the rotation of the rotary valve, the flow channel can communicate with the corresponding groove through the corresponding fluid channel and make the opening correspond to the corresponding air hole to facilitate the suction of the fluid; the rotary valve can be externally connected to a pump, which can provide positive and negative pressure to suck, discharge or transfer various reagents in each groove to other grooves; a sealing film arranged on the surface of the first cover to seal the fluid channels, gas channels and liquid temporary storage area into a closed channel.

2. The detection card cassette of claim 1, wherein, The first part and the second part have different materials respectively.

3. The detection cabinet according to claim 2, wherein, The second part of the rotary valve comprises a clamping part protruding into the second through hole.

4. The detection card cassette of claim 1, wherein, The flow channel is spindle-shaped or linear.

5. The detection card cassette of claim 1, wherein, The first suction pipe respectively extends downward along a surface of the first cover and protrudes outside another surface of the first cover.

6. The detection cabinet according to claim 1, wherein, The bottom of the first suction pipe has an inclined side wall.

7. The detection cabinet according to claim 1, wherein, The groove comprises a sample groove, at least one reaction groove and at least one reagent groove.

8. The detection cabinet according to claim 1, wherein, Each groove has an inclined part at least at the bottom of the groove.

9. The detection cabinet according to claim 8, wherein, The inclined part has an inclined wall surface.

10. The detection cabinet according to claim 1, wherein, Each groove further comprises a body and a film sealing the body.

11. The detection cabinet according to claim 1, wherein, One of the plurality of grooves further comprises a plurality of magnetic beads.

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