CN214654798U - Molecular diagnosis centrifugal test card - Google Patents

Abstract

The application provides a molecular diagnosis centrifugal test card, this molecular diagnosis centrifugal test card includes body and lid, and wherein, the body is equipped with application of sample chamber, the detection chamber of being connected with the application of sample chamber, and the lid is established on the application of sample chamber, and the lid is including the ventilative structure that blocks water. By the above mode, the molecular diagnosis centrifugal test card can prevent pollutants such as aerosol, biomolecules and the like generated in the amplification reaction from escaping, and avoid the pollution of detection to personnel and environment.

Description

Molecular diagnosis centrifugal test card

Technical Field

The utility model relates to a medical treatment detection and analysis technical field, concretely relates to molecular diagnosis centrifugation test card.

Background

Molecular diagnosis is to utilize molecular biology technology and method to study the existence, structure or expression regulation and control change of human endogenous or exogenous biological molecules and molecular systems, and provide information and decision basis for disease prevention, prediction, diagnosis, treatment and outcome. The microfluidic technology is a technology for processing or operating micro fluid by using a micro pipeline, and has the advantages of less sample consumption, high detection speed, simple and convenient operation, multifunctional integration, small size, convenience in carrying and the like, so that the microfluidic technology is particularly suitable for developing bedside diagnosis.

The POCT (Point-of-care test) system based on the microfluidic technology and the molecular diagnosis technology is used as a new product form development trend, and has the characteristics of simple user operation, low laboratory condition requirement, low pollution risk, high flux, multi-target joint inspection, short detection time, portability of instruments and the like. The POCT molecular diagnosis system can meet the requirement of rapid on-site detection, solves various pain points detected in a central laboratory, and is widely applied to the fields of clinical examination medicine, biochemistry, molecular biology and the like. In the related art, POCT molecular diagnostic systems generally include a sample application chamber and a detection chamber which are communicated with each other, and the sample application chamber is used for applying a sample solution to the detection chamber for a reaction between a reagent and the sample solution, however, in these systems, there are problems as follows:

2. the molecular diagnosis test card has no sealing and isolating measures, so that aerosol can escape from liquid in the molecular diagnosis test card in the amplification biochemical reaction process.

SUMMERY OF THE UTILITY MODEL

The utility model provides a molecular diagnosis centrifugation test card to the technical problem that aerosol effusion can appear at the liquid of molecular diagnosis test card in the solution correlation technique in the amplification biochemical reaction process.

In order to solve the technical problem, the utility model discloses a technical scheme be: providing a molecular diagnostic centrifugation test card comprising:

the body is provided with a sample adding cavity and a detection cavity connected with the sample adding cavity; and

the lid, the lid is established on the application of sample chamber, just the lid is including the ventilative structure that blocks water.

According to a specific embodiment of the present invention, the water-blocking and air-permeable structure has at least one hole, and each of the holes has a diameter smaller than 100 μm.

According to the utility model discloses a specific embodiment, the lid still includes the mounting, the ventilative structure that blocks water with the mounting is connected.

According to the utility model discloses a specific embodiment, the mounting is hollow barrel form, the ventilative structure that blocks water with the internal perisporium or the end connection of mounting.

According to the utility model relates to a specific embodiment, the application of sample chamber has the open end, the quantity of the ventilative structure that blocks water is one, just the mounting includes:

the first connecting cylinder is provided with a first end and a second end opposite to the first end, the first end is connected with the open end of the sample adding cavity, and the second end is far away from the open end;

the first assembling plate is connected to the second end of the first connecting cylinder and provided with a first assembling hole, and the water-blocking breathable structural component is assembled in the first assembling hole.

According to the utility model relates to a specific embodiment, the application of sample chamber has the open end, the quantity of the ventilative structure that blocks water is two, just the mounting includes:

the first connecting cylinder is provided with a first end and a second end opposite to the first end, the first end is connected with the open end of the sample adding cavity, and the second end is far away from the open end;

the first assembling plate is connected with the first connecting cylinder, a first assembling hole is formed in the first assembling plate, and one of the two air blocking and ventilating structures is assembled in the first assembling hole;

a second connector barrel connected with the second end of the first connector barrel;

the second assembly plate is connected to the end, far away from on the second connecting cylinder, of the first connecting cylinder, the second assembly plate is provided with a second assembly hole, and the other of the water-blocking and air-permeable structural members is assembled on the second assembly hole, and a cavity is formed between the first assembly plate and the second assembly plate.

According to the utility model discloses a specific embodiment, first assembly plate is kept away from the surface of the open end of application of sample chamber with distance between the second assembly plate is greater than first connecting cylinder the surface at second end place with distance between the second assembly plate.

According to a specific embodiment of the present invention, the first end of the first connecting cylinder is connected to the open end of the sample adding cavity by interference fit, screw, buckle or elastic tight fit; and/or

The second connecting cylinder is connected with the second end in an interference fit mode, a spiral mode, a buckling mode or an elastic tight-fitting mode.

According to the utility model relates to a specific embodiment, the application of sample chamber is including being close to the open end of lid one side, just the open end salient in the body, the lid with the internal periphery or the outer peripheral edge butt of the open end in application of sample chamber.

According to the utility model relates to a specific embodiment, the body includes base member and capping layer, the application of sample chamber detect the chamber setting on the base member, just still be equipped with waste liquid chamber and runner on the base member, the runner will the application of sample chamber with waste liquid chamber intercommunication, the capping layer connect in the surface and the closing cap of base member detect the chamber waste liquid chamber the runner.

The utility model has the advantages that: the molecular diagnosis centrifugal test card provided by the application can prevent pollutants such as aerosol, biological molecules and the like generated in amplification reaction from escaping and avoid the pollution of detection to personnel and environment by covering the sample application cavity with the cover body comprising the water-blocking and air-permeable structural part.

Drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings used in the description of the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without inventive efforts, wherein:

FIG. 1 is a schematic view of the overall structure of the centrifugal test card for molecular diagnosis provided by the embodiment of the present invention

Fig. 2 is an exploded view of the centrifugal test card for molecular diagnostics provided in an embodiment of the present invention;

FIG. 3 is a schematic diagram of an exploded structure of a centrifugal test card for molecular diagnostics according to another embodiment of the present invention;

FIG. 4 is a schematic diagram of a single-layer isolated reagent storage of a first separator according to an embodiment of the present invention;

FIG. 5 is a schematic diagram of a first separator for storing reagents in a multi-layer separation manner according to an embodiment of the present invention;

FIG. 6 is a schematic structural diagram of a molecular diagnostic centrifugal test card with a quantitative cavity according to an embodiment of the present invention;

fig. 7 is a schematic view of a blocking channel arranged linearly in a plane direction according to an embodiment of the present invention;

fig. 8 is a schematic view of the planar-direction blocking channel bending arrangement provided by the embodiment of the present invention;

fig. 9 is a schematic view of a curved arrangement of blocking passages in a planar direction according to an embodiment of the present invention;

FIG. 10 is a schematic cross-sectional view of a molecular diagnostic centrifugal test card with a quantitative cavity according to an embodiment of the present invention;

FIG. 11 is a cross-sectional view of a quantitative cavity with an opening at one end of the test card for molecular diagnostics centrifugation according to an embodiment of the present invention;

FIG. 12 is a schematic cross-sectional view of a quantitative cavity with openings at two ends of the molecular diagnostic centrifugal test card according to an embodiment of the present invention;

fig. 13 is a schematic flow chart of a one-step liquid separation detection method performed by the molecular diagnosis centrifugal test card provided in the embodiment of the present invention;

fig. 14 is a schematic flow chart of a two-step liquid separation detection method performed by the molecular diagnosis centrifugation test card provided in the embodiment of the present invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without creative work all belong to the protection scope of the present invention.

It should be noted that, if directional indications (such as upper, lower, left, right, front and rear … …) are involved in the embodiment of the present invention, the directional indications are only used to explain the relative position relationship between the components, the motion situation, etc. in a specific posture (as shown in the drawings), and if the specific posture is changed, the directional indications are changed accordingly.

In addition, if there is a description relating to "first", "second", etc. in the embodiments of the present invention, the description of "first", "second", etc. is for descriptive purposes only and is not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In addition, the technical solutions in the embodiments may be combined with each other, but it must be based on the realization of those skilled in the art, and when the technical solutions are contradictory or cannot be realized, the combination of the technical solutions should not be considered to exist, and is not within the protection scope of the present invention.

Referring to fig. 1-2, an embodiment of the present invention provides a molecular diagnostic centrifugal test card 1. In some embodiments, the molecular diagnostic centrifuge test card 1 may generally include a cover 100 and a body 200. The body 200 is provided with a sample addition chamber 210, a flow channel 220 communicating with the sample addition chamber 210, a detection chamber 230 connected with the flow channel 220, and a waste liquid chamber 240 communicating with the flow channel 220. The cover 100 is used for covering the sample adding cavity 210. The detection chamber 230 is also filled with a reagent 10, and the body 200 is also provided with fusible spacers (including, but not limited to, the first and second spacers 20 and 30 shown in fig. 2 and the third spacer 40 shown in fig. 8-9). The separator is switchable between a molten state and an unmelted state (typically solid). The separator may be controlled to be in an unmelted state when untested, wherein the separator may prevent the sample from entering the detection chamber 230 through the flow channel 220, and may also serve to seal the isolated reagent 10 to prevent the reagent 10 from entering the flow channel 220 backwards, i.e., to maintain the reagent 10 in the detection chamber 230. When a test is required, the separator can be controlled to be in a molten state, and at this time, the sample can enter the flow channel 220 through the sample application cavity 210 and then further enter the detection cavity 230 to react with the reagent 10 in the detection cavity 230, thereby completing the test.

Referring specifically to fig. 2, in some embodiments, the cover 100 is substantially cylindrical. Sample addition chamber 210 includes an open end 211 adjacent one side of cover 100. When the cover body 100 covers the sample adding cavity 210, the cover body 100 can abut against the inner periphery or the outer periphery of the opening end 211, so that the cover body 100 can be tightly matched with the sample adding cavity 210 on the body 200 to seal the sample adding cavity 210. The opening end 211 may protrude from the body 200, or may be flush with the body 200, or the opening end 211 may be recessed in the body 200. When the opening end 211 protrudes from the body 200, the cover 100 can abut against the outer or inner periphery of the opening end 211. When the open end 211 is flush with the body 200 or recessed with respect to the body 200, the cover 100 can abut against the inner periphery of the open end 211. In some embodiments, when the cover body 100 is mated with the inner periphery of the open end 211, the sealing surface is relatively smaller in area and the sealing effect is relatively better.

In some embodiments, with further reference to fig. 2, the cover 100 generally includes a fastener 110 and a water-blocking, breathable structure 120. The fixing member 110 is substantially a hollow cylinder, and the water-blocking and air-permeable structure 120 is connected to the fixing member 110. In some embodiments, the water-blocking and air-permeable structure 120 and the fixing member 110 may be fixedly connected to each other, for example, by integrally molding, gluing, ultrasonic welding, laser welding, etc. to the fixing member 110. Of course, in other embodiments, the water-blocking air-permeable structure 120 may be detachably connected to the fixing element 110, for example, the fixing element 110 may be made of a material such as rubber, and the water-blocking air-permeable structure 120 may be inserted into or abutted against the fixing element 110. The fixing member 110 may be integrally formed with the water-blocking and air-permeable structure member 120 or may be formed separately, which is not specifically limited in the embodiments of the present application.

In some embodiments, the water-blocking breathable structure 120 may be connected to the inner peripheral wall or end of the fixture 110. For example, in some embodiments, the water-blocking and air-permeable structure 120 may be a film structure and may be attached to the ends of the fixture 110 by a fitting manner. Of course, in other embodiments, the water-blocking and air-permeable structure 120 may be connected to the inner wall of the fixing member 110 by means of, for example, screw connection, adhesive bonding, interference fit, etc.

In some embodiments, the water-blocking air-permeable structure 120 has at least one hole, and each hole has a pore size of less than 100 μm. The vapor generated in heating the molecular diagnosis centrifugal test card 1 can be discharged through the hole, and the air pressure in the molecular diagnosis centrifugal test card 1 can be reduced. In some embodiments, the pore size of each pore may be about 0.1-100 μm. In some embodiments, the number of the holes may be multiple, that is, the water-blocking air-permeable structure 120 may be a porous structure. In some embodiments, the water-blocking and air-permeable structure 120 may be a PE (polyethylene) sintered filter element or a PTFE (polytetrafluoroethylene) hydrophobic and air-permeable membrane. The fixing member 110 may be made of ABS (Acrylonitrile Butadiene Styrene), PP (Polypropylene), PDMS (Polydimethylsiloxane), PE (Polyethylene), or rubber. Of course, in other embodiments, the fixing member 110 and the water-blocking and air-permeable structure 120 may be implemented by other materials or other structures. The material of the fixing member 110 and the water-blocking air-permeable structure member 120 is not particularly limited.

In some embodiments, as shown in fig. 2, the water-blocking air-permeable structure 120 may be a porous sintered filter element such as described above, the number of water-blocking air-permeable structures 120 is one, and the fixture 110 is a single-layer cover structure. The fixing member 110 may generally include a first connecting cylinder 111 and a first mounting plate 112 connected to the first connecting cylinder 111. The first connecting cylinder 111 can be connected with the inner periphery or the outer periphery of the open end 211 of the sample application cavity 210 in an interference fit, spiral, snap or elastic tight fit manner. The water-blocking air-permeable structure 120 is disposed on the first mounting plate 112. The first connecting cylinder 111 may be integrally formed with the first mounting plate 112 or may be formed separately.

In some embodiments, with further reference to fig. 2, the first connecting cylinder 111 includes a first end 1111 and a second end 1112 disposed opposite the first end 1111. First end 1111 is connected to open end 211 of sample addition chamber 210, and second end 1112 is disposed distal to open end 211. The first assembly plate 112 is coupled to the second end 1112 of the first connecting cylinder 111. The first mounting plate 112 is provided with a first mounting hole 1121, and the water-blocking and air-permeable structural member 120 can be mounted in the first mounting hole 1121.

In other embodiments, the water-blocking air-permeable structure 120 may also be a hydrophobic air-permeable membrane structure, and the water-blocking air-permeable structure 120 may be attached to and seal the first mounting hole 1121. Wherein the hydrophobic breathable film structure may comprise one or more layers of hydrophobic breathable film.

The above is given to the structure in which the fixing member 110 includes the first connecting cylinder 111 and the first fitting plate 112. However, in other embodiments, the fixing member 110 may not include the first mounting plate 112, but only include the first connecting cylinder 111 with two open ends. At this time, the water-blocking and air-permeable structure 120 may also be a hydrophobic and air-permeable membrane structure, and may be connected to the end of the fixing member 110 by means of fitting. Of course, in other embodiments, the water-blocking and air-permeable structure 120 is a porous sintered filter element as described above and is attached to the inner wall of the fixture 110 by, for example, screwing, gluing, interference fit, etc. The specific structure or implementation of the components included in the fixing member 110 and the water-blocking and air-permeable structure 120 are not limited in this application.

In another embodiment, as shown in fig. 3, the water-blocking air-permeable structure 120 may be a porous sintered filter element such as described above, the number of the water-blocking air-permeable structures 120 is two, and the fixing member 110 is a double-cover structure. The fixing member 110 may generally include a first connecting cylinder 111, a first mounting plate 112, a second connecting cylinder 113, and a second mounting plate 114. Specifically, the first connecting cylinder 111 has a first end 1111 and a second end 1112 disposed opposite to the first end 1111. First end 1111 is connected to open end 211 of sample addition chamber 210, and second end 1112 is disposed distal to open end 211. The first mounting plate 112 is connected to the first connecting cylinder 111, a first mounting hole 1121 is formed in the first mounting plate 112, and one of the water-blocking and air-permeable structural members 120 is mounted in the first mounting hole 1121.

The second connector barrel 113 is connected to the second end 1112 of the first connector barrel 111. The second fitting plate 114 is attached to an end of the second connecting cylinder 113 remote from the first connecting cylinder 111. The second mounting plate 114 is provided with a second mounting hole 1141, the other water-blocking and air-permeable structure 120 is mounted on the second mounting hole 1141, and a cavity is formed between the first mounting plate 112 and the second mounting plate 114.

During the heating of the molecular diagnostic centrifuge test card 1, the generated water vapor will be discharged from the water-blocking and air-permeable structure 120, and the water vapor will form water drops when it is cooled and condense around the cover 100. When the molecular diagnostic centrifugal test card 1 is centrifugally rotated, water droplets may be thrown into the test instrument, resulting in damage to the test instrument. The cavity formed between the first assembling plate 112 and the second assembling plate 114 can collect condensed water formed by partial water vapor, and the condensed water formed on the periphery of the cover body 100 is reduced, thereby playing a role of protecting the detection instrument.

In some embodiments, the distance between the surface of the first assembly plate 112 away from the open end 211 of the sample adding cavity 210 and the second assembly plate may be greater than the distance between the surface of the second end 1112 of the first connecting cylinder 111 and the second assembly plate 114, and the first assembly plate 112 may be connected to the inner circumference of the first connecting cylinder 111, so that the cavity formed between the first assembly plate 112 and the second assembly plate 114 is further increased. In some embodiments, the first end 1111 of the first connecting cylinder 111 can be connected to the inner or outer circumference of the open end 211 of the sample application cavity 210 by interference fit, screwing, snapping, or elastic interference fit. The second connector barrel 112 may be connected to the inner or outer periphery of the second end 1112 of the first connector barrel 111 by interference fit, screwing, snapping, or elastic interference fit. Wherein the sealing surface has a relatively smaller area and a better sealing effect when coupled to the inner circumference of the open end 211 and the inner circumference of the second end 1112.

In some embodiments, the first connecting cylinder 111 and the first assembling plate 112 may be integrally formed, or may be separately formed and then connected to each other by, for example, adhesion, welding, or the like. Similarly, the second connecting tube 113 and the second mounting plate 114 may be integrally formed with each other, or may be separately formed and then connected to each other by, for example, adhesion, welding, or the like. This is not a particular limitation of the present application.

Of course, in other embodiments, the water-blocking air-permeable structure 120 may also be a hydrophobic air-permeable membrane structure, and the number of the water-blocking air-permeable structure 120 is two. Wherein each hydrophobic breathable film structure may comprise one or more layers of hydrophobic breathable film. One of the water-blocking air-permeable structures 120 may be attached to seal the first mounting hole 1121 of the first mounting plate 112, and the other water-blocking air-permeable structure 120 may be attached to the second connecting cylinder 113 at an end away from the first connecting cylinder 111 and cover the second mounting hole 1141 of the second mounting plate 114, so that a cavity may be formed between the two water-blocking air-permeable structures 120.

The above is given to the structure in which the fixing member 110 includes the first connecting cylinder 111, the first assembly plate 112, the first connecting cylinder 113, and the second assembly plate 114. However, in other embodiments, the fixing member 110 may not include the first assembly plate 112 and/or the second assembly plate 114, for example, only include the first connecting cylinder 111 with two open ends and the second connecting cylinder 113 with two open ends, or one of the first connecting cylinder 111 and the second connecting cylinder 113 may have two open ends and the other may have an assembly plate (e.g., the first assembly plate 112 or the second assembly plate 114) correspondingly disposed thereon. At this time, the water-blocking and air-permeable structure 120 may also be a hydrophobic and air-permeable membrane structure, and may be connected to the first connecting cylinder 111 and/or the second connecting cylinder 113 by means of fitting. Of course, in other embodiments, the water-blocking and air-permeable structure 120 is a porous sintered filter element as described above and is attached to the inner wall of the first connector barrel 111 and/or the second connector barrel 113 by, for example, screwing, bonding, etc. The specific structure or implementation of the components included in the fixing member 110 and the water-blocking and air-permeable structure 120 are not limited in this application.

In some embodiments of the present application, the sample application cavity 210 is sealed by the cover body 100 provided with the water-blocking air-permeable structural member 120, so that the molecular diagnosis centrifugal test card 1 can discharge water vapor generated in the heating process, and reduce the air pressure in the molecular diagnosis centrifugal test card 1, thereby ensuring a good air-permeable effect, and can prevent pollutants such as aerosol and biomolecules generated in the amplification reaction from escaping, thereby avoiding pollution of detection to personnel and environment.

Referring to fig. 2-3, in some embodiments of the present application, the body 200 is substantially a fan-shaped structure, which may be a fan ring, a fan blade, or a pie. The included angle of the straight line edge of the fan-shaped structure of the body 200 can be 40-60 degrees, the inner side and the outer side are both arc edges (also can be straight line edges), the diameter of the inner arc edge can be 10-100 mm, and the diameter of the outer arc edge can be 100-200 mm. The molecular diagnosis centrifugal test card 1 adopting the size structure can be arranged at least 6 in the plane of the detector to form a circular surface, so that the molecular diagnosis centrifugal test card 1 with at least 6 can be simultaneously detected, the overall detection efficiency is improved, and the detection requirement on a larger scale can be met.

In some embodiments, with further reference to fig. 2-3, body 200 includes a base 201 and a capping layer 202. Wherein, the sample adding cavity 210, the flow channel 220, the detection cavity 230 and the waste liquid cavity 240 are arranged on the substrate 201. The capping layer 202 is attached to the surface of the base 201 and covers the flow channel 220, the detection chamber 230, and the waste chamber 240. In some embodiments, the detection chamber 230 and the waste chamber 240 may not penetrate the substrate 201, and the capping layer 202 is one layer and covers one side of the opening of the substrate 201. In other embodiments, the detection chamber 230 and the waste chamber 240 may also penetrate through the substrate 201, and in this case, the number of the capping layers 202 is two, and the capping layers are capped on two opposite sides of the substrate 201.

The substrate 201 may be made of ABS (Acrylonitrile Butadiene Styrene), PDMS (Polydimethylsiloxane), PC (Polycarbonate), PMMA (Polymethyl methacrylate), PS (General purpose polystyrene), PP (Polypropylene), COC (copolymers of Cyclo Olefin), COP (Cyclo Olefin Polymer), etc. and may be processed by injection molding, numerical control machine processing, or 3D printing. The capping layer 202 may be made of a material such as a sealing adhesive, an ultraviolet light curing adhesive, or an optical double-sided adhesive, or may be made of a material similar to that of the base 201. The seal between the capping layer 202 and the substrate 201 may be performed by, for example, ultrasonic welding, laser welding, adhesive sealing, or the like.

In addition, the bottom of the body 200 may be provided with a plurality of different protrusions or grooves 203, such as at three vertices of a fan-shaped structure. These protrusions or recesses 203 may be used to engage with retaining structures on the tray or the test instrument to position and secure.

The shapes of the areas of the sample adding cavity 210, the detection cavity 230 and the waste liquid cavity 240 can be circular arc, circle, rectangle or other polygons. The sample application chamber 210 is mainly used for pretreatment of the liquid sample, and the pretreatment may include one or more of chemical treatment, thermal treatment, enzymatic treatment, physical separation, and the like. In some embodiments, the loading chamber 210 has a volume of approximately 200-. The sample loading cavity 210 can be pre-loaded with a dry reagent, can be air-dried/dried in situ, or can be added into the sample loading cavity 210 as a freeze-dried reagent. The sample adding cavity 210 is matched with the cover body 100 to realize the sealing of the molecular diagnosis centrifugal test card 1.

The flow passage 220 may generally include a buffer region 221, an exhaust region 222, an over-flow region 223, and a flow-splitting region 224. The buffer area 221 and the exhaust area 222 may have a circular arc shape, a circular shape, a rectangular shape, or other polygonal shapes. The shape of the over-flow region 223 may be a rectangle, a circular ring, a circular arc, an arch structure, or a bent structure. The diverter region 224 may be in the shape of a circular arc, a rectangle, or other polygonal configuration. In some embodiments, the number of exhaust areas 222 may be one or more. When the number of the exhaust areas 222 is plural, the plural exhaust areas 222 may be directly communicated with the buffer area 221, or the plural exhaust areas 222 may be communicated with each other, and then the exhaust area 222 adjacent to the buffer area 221 is communicated with the buffer area 221. The number of exhaust areas 222 is not particularly limited herein.

Wherein, the buffer area 221 is communicated with the sample adding cavity 210, and can be used for temporarily storing the sample liquid in the centrifugal process.

The air-vent region 222 can be used to vent the waste air generated during the process, for example, the air can be vented into the air-vent region 222 when the sample flows from the sample-loading chamber 210 into the buffer region 221, or the water vapor generated during the heating process of the molecular diagnostic centrifuge test card 1 can be vented into the air-vent region 222.

The over-flow zones may generally include a first over-flow zone 2231, a second over-flow zone 2232, a third over-flow zone 2233, and a fourth over-flow zone 2234. Wherein the sample application chamber 210 communicates with the buffer region 221 through the first flow-through region 2231, the gas discharge region 222 communicates with the buffer region 221 through the second flow-through region 2232, the buffer region 221 communicates with the flow-splitting region 224 through the third flow-through region 2233, and the flow-splitting region 224 communicates with the waste liquid chamber 240 and communicates with the gas discharge region 222 through the fourth flow-through region 2234. Detection chamber 230 is connected to diverter region 224.

Here, there may be one or more second overcurrent areas 2232, and the opening of the second overcurrent area 2232 may be at any position on the inner wall of the buffer area 221. The second over-flow region 2232 is for a siphon action or a capillary micro-valve action. And the third and fourth flow-through regions 2233 and 2234 can be capillary valves, trap valves, siphon valves, and the like.

In some embodiments, referring further to fig. 3, the width dimension of the buffer region 221 may be greater than the width dimension of the third over-current region 2233.

Referring to FIG. 3, the detection chamber 230 may be a substantially conical, cylindrical-conical composite or rectangular structure, and may have a volume of 10-100 μ l. Wherein, the depth of the detection cavity 230 is greater than the depth of the flow channel 220. In some embodiments, a bypass 250 may also be provided between detection chamber 230 and flow channel 220 (and specifically diverter region 224). In some embodiments, the number of the detection cavities 230 may be multiple, and the number of the branches 250 is also multiple, and the detection cavities 230 correspond to the branches 250 one by one. Each detection chamber 230 may be connected to diverter region 224 by a branch 250. In addition, the detection cavities 230 are isolated from each other, so that the probability of reaction cross contamination among different detection cavities 230 can be reduced, and the same sample can be used for differential diagnosis of multiple pathogens at the same time by placing different reaction reagents in different detection cavities 230. In the embodiment shown in fig. 3, the number of detection chambers 230 is 5, and the number of branches 250 is also 5. .

Referring also to fig. 4-5, in some embodiments, the reagent 10 and the meltable first separator 20 are stacked within the detection chamber 230. In some embodiments, the first insulation 20 may be paraffin, microcrystalline wax, synthetic wax, or natural wax. The first separator 20 is characterized in that it is solid at normal and low temperatures, turns into liquid after being heated to a specific temperature, and has no inhibitory effect on nucleic acid amplification reaction. In some embodiments, the reagent 10 is a dry reagent comprising one or more of primers and DNA (deoxyribonucleic acid) binding dyes, enzymes, magnesium sulfate, potassium chloride, dNTPs (nucleotide triphosphates) used for the amplification reaction. The dry reagent 10 is loaded in the detection chamber 230 in a liquid state, and the dry reagent 10 is formed through a drying process, the temperature of which is lower than the melting temperature of the first separator 20, the drying process including air drying, oven drying, and freeze drying. In the heating process of detection, the reagent 10 and the first insulator 20 are both in liquid state, and since the specific gravity of the first insulator 20 is smaller than that of the reagent 10, the first insulator 20 is displaced out of the detection chamber 230 under the action of the centrifugal field, thereby not affecting the reaction and detection.

Therefore, when such a first separator 20 is used, the first separator 20 can be loaded in the detection chamber 230 in a molten state and molded by natural solidification or solidification at a reduced temperature. When not being tested, the first separator 20 may be controlled to be in a molten state, at which time the sealed and isolated storage of the reagent 10 may be achieved by the first separator 20. When a test needs to be performed, the first isolation body 20 may be controlled to be in a molten state, for example, by heating the molecular diagnostic centrifugal test card 1, so that the first isolation body 20 is heated and melted, at this time, the first isolation body 20 may move out of the detection cavity 230 and flow to the end of the branch channel 250 under the action of centrifugal force, and a sample may enter the detection cavity 230 through the branch channel 250, and then the first isolation body 20 is cured again to block the end of the branch channel 250, thereby forming mutually isolated seals for the plurality of detection cavities 230, so as to facilitate independent reaction or test between the detection cavities 230.

As shown in FIG. 4, in some embodiments, the number of layers of the reagent 10 may be one, with the reagent 10 being located at the bottom of the detection chamber 230. And the first separator 20 may comprise a facing separator 21. The facing layer separator 21 covers the reagent 10 and is in sealing engagement with the inner peripheral wall of the detection chamber 230. In this way, the reagent 10 can be isolated from the outside by the first isolation body 20 when not being tested, thereby effectively increasing the storage time of the reagent 10 and reducing the possibility of contamination of the reagent 10. In the heating process of detection, the reagent 10 and the first insulator 20 are both in liquid state, and since the specific gravity of the first insulator 20 is smaller than that of the reagent 10, the first insulator 20 is displaced out of the detection chamber 230 under the action of the centrifugal field, thereby not affecting the reaction and detection.

In some embodiments, referring to fig. 5, the first separator 20 may be at least one layer of the separators 22, and the reagent 10 has a plurality of layers, the plurality of layers of the reagent 10 being spaced apart from each other, and two adjacent layers of the reagent 10 may be sealed at intervals by the layer of the separators 22.

For example, in the embodiment shown in fig. 5, two layers of reagents 10 may be included, and the types of the two layers of reagents 10 may be different, namely, a first reagent 11 and a second reagent 12. The reagent 11 and the reagent 12 may be sealed at intervals in layers by an interlayer separator 22. Of course, in other embodiments, three or more layers of reagents may be included, and these may be stacked in between, for example: by the above manner, the first reagent 11+ the interlayer isolation body 22+ the second reagent 12+ the interlayer isolation body 22 … … can realize that a plurality of reagents 10 are simultaneously stored in the detection cavity 230 in an isolated manner and protected from the outside, thereby effectively prolonging the storage time of the reagents 10 and reducing the possibility of pollution of the reagents 10. Meanwhile, in the detection heating process, the plurality of reagents 10 and the plurality of layers of first separators 20 are in a liquid state, and since the specific gravity of the first separators 20 is smaller than that of the reagents 10, the first separators 20 are displaced out of the detection chamber 230 under the action of the centrifugal field, so that the reaction and detection are not affected.

In some embodiments, with further reference to FIG. 5, the first separator 20 can further comprise a surface layer separator 21, and the surface layer separator 21 covers the top surface of the topmost reagent 10 and is in sealing engagement with the inner peripheral wall of the detection chamber 230 for further sealing separation of the reagent 10 in the detection chamber 230.

In some embodiments of the present application, the reagent 10 is protected from the outside by covering the first isolation body 20 on the upper surface of the reagent 10 at the bottom of the detection chamber 230, so that the preservation time of the reagent 10 is effectively prolonged, and the reagent 10 is prevented from being polluted. The interlayer isolation body 22 is arranged to isolate the multiple reagents 10 (reagent 11/reagent 12) in a layered manner, so that the detection cavity 230 can simultaneously store multiple dry reagents 10 in an isolated manner, and the molecular diagnosis centrifugal test card 1 has multiple functions and wider application range.

The reagent 10 and the first isolating body 20 can be pre-assembled in various ways, such as manual pipetting, machine pipetting, manual dispensing, machine dispensing, and the like. The processing sequence is firstly reagent 11, drying, interlayer isolation 22, solidifying, reagent 12 and drying. When the molecular diagnostic centrifuge test card 1 is packaged/sealed after the preassembly of the reagent 10 and the first insulating body 20 is completed, a high-temperature heat source or a long-time heating mode is avoided as much as possible, and if heating is needed, the heating temperature needs to be 5-10 ℃ lower than the melting temperature of the first insulating body 20.

In some embodiments, the branch 250 has a depth of 1mm or less and a width of 1mm or less. Branch 250 communicates with diverging region 224. Referring further to fig. 2-3, an isolation chamber 251 may also be provided in the branch 250. Herein, the isolation chamber 251 may be disposed at any position of the branch passage 250, and the number of the isolation chamber 251 may be one or more. The isolation chamber 251 may be a cylindrical recess, and the volume of the isolation chamber 251 may be 5-50 μ l. A second separator 30 may be disposed within the separation cavity 251. Wherein, the material of the second separator 30 is the material of the first separator 20 as described above, and the description thereof is omitted. The material of the second separator 30 may be the same as or different from that of the first separator 20. The second isolating body 30 is used for sealing the inlet of the detection chamber 230, so that the whole course of the reaction liquid is isolated from the outside in the amplification process, the aerosol can be effectively isolated, and the possibility of pollution of detection to personnel and environment is reduced.

Referring to fig. 6-12, in some embodiments, the molecular diagnostic centrifugation test card 1 includes a cover 100 and a body 200. The body 200 is provided with a sample addition chamber 210, a flow channel 220 communicating with the sample addition chamber 210, a detection chamber 230 connected with the flow channel 220, and a waste liquid chamber 240 communicating with the flow channel 220. The structural arrangement and connection relationship among the cover 100, the sample-adding cavity 210, the flow channel 220, and the detection cavity 230 can be seen in the embodiments shown in fig. 2-5, and are not described herein again. Unlike the previous embodiments, in the embodiment shown in fig. 6-12, the body 200 is not provided with the branch 250, but is provided with the dosing chamber 260. The quantitative chamber 260 is in communication with the flow channel 220 (specifically, the flow splitting region 224) and the detection chamber 230, respectively. In one embodiment, the number of the detection chambers 230 may be plural, and the number of the quantitative chambers 260 may be correspondingly plural, and each quantitative chamber 260 is connected to one detection chamber 230.

The quantitative cavity 260 may be a groove structure, has a predetermined volume, can be used for temporarily storing the sample liquid, and can quantify the volume of the sample liquid. In some embodiments, the predetermined volume is substantially in the range of 5 μ l to 100 μ l. The cross-sectional shape of the quantitative cavity 260 may be an arch, a circular arc, a triangle, a rectangle, etc., and other polygons.

Referring further to fig. 6-12, an isolation channel is provided between the dosing chamber 260 and the detection chamber 230, the third separator 40 is disposed within the isolation channel, and when the third separator 40 is melted, the isolation channel allows liquid to flow from the dosing chamber 260 to the detection chamber 230 under the influence of centrifugal force and prevents liquid in the detection chamber 230 from flowing back to the dosing chamber 260.

In some embodiments, the isolation channel is disposed in the card-plane direction of the molecular diagnostic centrifugation test card 1. As shown in FIGS. 7 to 9, the isolation channel may have a straight shape (as shown in FIG. 7), a bent straight shape (as shown in FIG. 8), or a curved shape (as shown in FIG. 9), and includes a first channel 261 adjacent to the dosing chamber 260, a second channel 263 adjacent to the detection chamber 230, and a blocking chamber 262 between the first channel 261 and the second channel 263 for installing the third separator 40. By using the isolation channel with a straight bending shape or a curved shape, the liquid in the detection chamber 230 can be better prevented from flowing back to the quantitative chamber 260.

In some embodiments, the isolation channel is disposed in a card thickness direction of the molecular diagnostic centrifugation test card 1. As shown in FIGS. 10 to 12, the isolation path includes a first path 261 adjacent to the quantifying chamber 260, a second path 262 adjacent to the detecting chamber 230, and an isolation chamber 262 between the first path 261 and the second path 263 for accommodating the third isolating body 40, and the first path 261, the isolation chamber 262, and the second path 263 may constitute a stepped path.

The material of the third separator 40 is the material of the first separator 20 as described above, and will not be described in detail here. For example, the third separator 40 may be one of paraffin, microcrystalline wax, synthetic wax, or natural wax.

In this embodiment, when the centrifugal test card 1 for molecular diagnostics is rotated centrifugally, the sample liquid flows to the quantification chamber 270 through the sample application chamber 210 and the flow channel 220. The third separator 40 is in a solid state, so that the blocking chamber 262 between the quantitative chamber 260 and the detection chamber 230 is sealed, the sample liquid cannot flow to the detection chamber 230, only the quantitative chamber 260 is filled, and the surplus liquid flows to the waste liquid chamber 240. After the sample liquid is heated, the third insulating body 40 is heated to melt and flow to the detection cavity 230, so that the quantitative cavity 260 and the detection cavity 230 can be communicated, and the quantitative sample liquid in the quantitative cavity 260 can flow into the detection cavity 230 through the first channel 261, the blocking cavity 262 and the second channel 263. Since the third separator 40 has a specific gravity smaller than that of the reagent 10, the third separator 40 is displaced above the reagent 10 by the centrifugal field, and the reaction and detection are not affected, and the detection chamber 230 can be sealed.

In some embodiments, body 200 includes a base 201 and a capping layer 202. The materials and processing manners of the substrate 201 and the capping layer 202 can be described with reference to the embodiments shown in fig. 2-3. Wherein, the sample adding cavity 210, the flow channel 220, the detection cavity 230, the waste liquid cavity 240 and the quantitative cavity 260 are arranged on the substrate 201. The capping layer 202 is attached to the surface of the base 201 and covers the flow channel 220, the detection chamber 230, the waste chamber 240, and the quantification chamber 260.

In some embodiments, the detection chamber 230, the blocking chamber 262 and the quantitative chamber 260 may not penetrate through the substrate 201, and the capping layer 202 is formed in one layer and covers one side of the opening of the substrate 201. For example, referring to fig. 8, in some embodiments, the substrate 201 has a top surface and a bottom surface, which are the two sides of the substrate 201 in the thickness direction. The dosing chamber 260, the blocking chamber 262 and the detection chamber 230 have an open end on one of the top and bottom surfaces and a closed end on the other of the top and bottom surfaces. In addition, the base 201 has a first connection 2011 between the dosing chamber 260 and the blocking chamber 262 and a second connection 2012 between the blocking chamber 262 and the detection chamber 230.

When the open end is located on the top surface, as shown in fig. 11, the first connecting portion 2011 and the bottom surface are spaced to form a first channel 261, the second connecting portion 2012 and the plane of the top surface are spaced to form a second channel 263, and the second channel 263 extends through to the top surface. The capping layer 202 caps the top surface of the substrate 201.

In some embodiments, when the open end is located at the bottom surface (not shown), the first connecting portion 2011 and the plane of the bottom surface are spaced to form the first channel 261, the second connecting portion 2012 and the top surface are spaced to form the second channel 263, and the first channel 261 extends through to the bottom surface. The capping layer 202 caps the bottom surface of the substrate 201.

In some embodiments, the detection chamber 230, the blocking chamber 262 and the quantitative chamber 260 may also penetrate through the substrate 201, and at this time, the number of the capping layers 202 is two and the capping layers are capped on two opposite sides of the substrate 201. For example, referring to fig. 12, the base 201 has a top surface and a bottom surface, and the dosing chamber 260, the blocking chamber 262 and the detection chamber 230 each have two open ends in a direction from the top surface toward the bottom surface. The first channel 261 is formed to be recessed from the bottom surface of the base 201 toward the top surface of the base 201, the second channel 263 is formed to be recessed from the top surface of the base 201 toward the bottom surface of the base 201, and both the recessed depth of the first channel 261 and the recessed depth of the second channel 263 are smaller than the depth of the detection chamber 230. Two capping layers 202 may cap the top and bottom surfaces of the substrate 201.

In some embodiments of the present application, the quantitative liquid distribution is realized by the quantitative cavity 260 and the third isolating body 40, so that the third isolating body 40 can realize quantitative liquid distribution through the quantitative cavity 260 before melting, and can further assist the mutually isolated storage of the reagents in the detection cavity 230. After being heated and melted, the quantitative cavity 260 can be communicated with the detection cavity 230 so that the sample can enter the detection cavity 230 for subsequent detection, and meanwhile, the third isolating body 40 can further play a role in sealing the detection cavity 230, thereby realizing the automation of quantitative detection and analysis of the sample reagent of the molecular diagnosis centrifugal test card 1.

Some embodiments of the present application also provide a method for performing detection based on the above-mentioned molecular diagnostic centrifugation test card 1. Fig. 13 shows a method of detection based on the molecular diagnostic centrifuge test card 1 in the embodiment shown in fig. 2-3. As shown in fig. 13, in some embodiments, the specific steps of the one-step liquid separation detection method are as follows:

step S10: sample application chamber 210 receives a sample.

In this step, the sample is pretreated by heating. The heating mode can be a metal heating block, a heating air flow, an electromagnetic wave (infrared radiation, laser, microwave) and the like. The heating regions of the molecular diagnosis centrifugal test card 1 are non-overlapping heating regions, so that independent heating at different time points can be realized, and in the step, only one heating region (namely, the vicinity of the sample adding cavity 210) needs to be heated. The heating zone is warmed to a specified temperature, such as 90 ℃. And after reaching the specified temperature, preserving heat for 3-10min according to the specified requirement to realize pretreatment. After the pretreatment is completed, the temperature of the sample liquid is lowered to a prescribed temperature, for example, 60 ℃.

Step S11: the molecular diagnostic centrifugation test card 1 is rotated by a centrifugal force to allow the sample to flow toward the detection chamber 230 through the flow channel 220.

In this step, the molecular diagnostic centrifuge test card 1 needs to be rotation-controlled. For example, the direction of rotation may be controlled to be clockwise, the rotation speed greater than 1000rpm, and the rotation time about 10-15 s. By rotation, the sample liquid can flow from the sample application chamber 210 to the detection chamber 230 through the buffer zone 221 of the flow channel 220, so as to subsequently fill the detection chamber 230 with the sample. And excess sample fluid will enter waste chamber 240.

Step S12: the heat melts the separator to cause the sample to flow into the detection chamber 230 and mix with the reagent 10 in the detection chamber 230.

In this step, the heating second region (i.e., the vicinity of the detection chamber 230) is heated so that the temperature of the heating second region is higher than the melting point of the first separator 20 and the second separator 30 of the isolation chamber 251, thereby melting the first separator 20 and the second separator 30 of the isolation chamber 251, and mixing the sample with the reagent in the detection chamber 230.

Step S13: the centrifuge spins to displace the separator from the sample in the detection chamber 230 and seal the inlet end of the detection chamber 230.

In this step, the molecular diagnostic centrifuge test card 1 is subjected to rotation control. Wherein, the motor can rotate along the clockwise direction, the rotating speed is more than 1000rpm, and the rotating time is 10-15 s. At this time, the sample enters the detection chamber 230 due to the rotation of the molecular diagnostic centrifuge test card 1, and the first separator 20 and the aqueous solution in the detection chamber 230 are displaced, and the first separator 20 is transferred to the inlet end of the detection chamber 230, thereby completing the sealing of each detection chamber 230. And then changing the control parameters of the motor to make the molecular diagnosis centrifugal test card 1 rotate clockwise and anticlockwise alternately. For example, the molecular diagnostic centrifuge test card 1 may be controlled to rotate clockwise at a rotation speed of 3000rpm for a rotation time of 1s, and then rotate counterclockwise at a rotation speed of 3000rpm for a rotation time of 1s, alternately rotating 10 to 15 times. The clockwise and counterclockwise rotation can make the sample and the reagent in the detection chamber 230 mix and dissolve completely. Meanwhile, the separator flows to the inlet end of the detection chamber 230 by centrifugal force after being heated and melted, to seal the inlet end of the detection chamber 230.

Step S14: and detecting the mixed reagent.

In this step, an amplification reaction and detection are required. If real-time detection is used, detection and amplification reactions are performed simultaneously, and if endpoint detection is used, detection is performed after amplification is complete. Wherein, the amplification reaction can be realized by the following modes: the heating zone two (i.e. near the detection chamber 230) is heated, and the temperature is controlled within the range of 60-75 ℃. And after the heating zone II reaches the specified temperature, preserving the heat for 30-60min according to the specified requirement to finish the amplification reaction.

Fig. 14 shows a method of detection based on the molecular diagnostic centrifuge test card 1 in the embodiment shown in fig. 6-12. As shown in fig. 14, in another embodiment of the present application, a two-step liquid separation detection method is implemented, and the detection method specifically includes the following steps:

step S20: sample application chamber 210 receives a sample.

In this step, the sample processing method of the sample addition chamber 210 is the same as that in step S10, and will not be described in detail here.

Step S21: the molecular diagnostic centrifugal test card 1 is rotated by centrifugal force to make the sample flow to the quantitative cavity 260 through the flow channel 220 and fill the quantitative cavity 260.

In this step, the molecular diagnostic centrifuge test card 1 needs to be rotated and controlled, and the rotation parameters are set to be clockwise in the rotation direction, the rotation speed is more than 1000rpm, and the rotation time is 10-15 s. The sample liquid flows from the sample application chamber 210 to the quantitative chamber 260 through the flow channel 220, and fills the quantitative chamber 20. Excess sample fluid will enter waste chamber 240.

Step S22: the third separator 40 is melted by heating so that the sample of the quantitative chamber 260 flows into the detection chamber 230.

In this step, the heating second zone is heated so that the temperature of the heating second zone is higher than the melting points of the first and third separators 20 and 40, and the first and third separators 20 and 40 in the detection chamber 230 are melted, so that the sample flows from the quantification chamber 260 into the detection chamber 230 through the first channel 261, the blocking chamber 262, and the second channel 263, and is mixed with the reagent in the detection chamber 230.

Step S23 is centrifugal rotation to displace the separator with the sample in the detection chamber 230 and seal the inlet end of the detection chamber 230.

In this step, the molecular diagnostic centrifuge test card 1 is subjected to rotation control. Wherein, the motor can rotate along the clockwise direction, the rotating speed is more than 1000rpm, and the rotating time is 10-15 s. At this time, due to the rotation of the molecular diagnostic centrifuge test card 1, the sample in the quantitative chamber 260 enters the detection chamber 230, and the first separator 20 and the aqueous solution in the detection chamber 230 are displaced, the first separator 20 and the third separator 40 can be transferred to the inlet end of the detection chamber 230, thereby completing the sealing of each detection chamber 230. And then changing the control parameters of the motor to make the molecular diagnosis centrifugal test card 1 rotate clockwise and anticlockwise alternately. For example, the molecular diagnostic centrifuge test card 1 may be controlled to rotate clockwise at a rotation speed of 3000rpm for 1s and then rotate counterclockwise at a rotation speed of 3000rpm for 1s, and to rotate alternately 10-15 times, so that the sample in the detection chamber 230 is mixed with the reagent and completely dissolved. Meanwhile, the first separator 20 and the third separator 40 flow to the inlet end of the detection chamber 230 by centrifugal force after being heated and melted, to seal the inlet end of the detection chamber 230.

Step S24: and detecting the mixed reagent.

In this step, the processing method for detecting the mixed reagent is the same as that in step S14, and will not be described in detail here.

In summary, in some embodiments of the present application, the integrated design eliminates the need for higher environmental requirements for molecular diagnostics, thereby greatly reducing the detection time; the water-blocking and air-permeable structural member 120 is arranged on the cover body 100 to cover the sample adding cavity 210, so that the molecular diagnosis centrifugal test card 1 can ensure good air permeability, reduce the air pressure in the molecular diagnosis centrifugal test card 1, has good sealing performance and can prevent pollutants such as aerosol, biological molecules and the like from escaping; the first isolating body 20 covers the upper surface of the reagent 10 at the bottom of the detection cavity 230, so that the reagent 10 is protected from the outside, the storage time of the reagent 10 is effectively prolonged, and the pollution of the reagent 10 is avoided; the detection chamber 230 can store a plurality of dry reagents 10 by the first separator 20 as a plurality of reagents 10 (reagent 11/reagent 12); through being equipped with quantitative chamber 260 and third insulator 40 for third insulator 40 plays the quantitative liquid effect of dividing before melting, plays the effect of sealed detection chamber 230 after melting, has realized the automation of the quantitative determination analysis of molecular diagnosis centrifugal test card 1 sample reagent, and isolated aerosol effectively avoids detecting the pollution to personnel and environment.

The above is only the embodiment of the present invention, not the limitation of the patent scope of the present invention, all the equivalent structures or equivalent processes that are used in the specification and the attached drawings or directly or indirectly applied to other related technical fields are included in the patent protection scope of the present invention.

Claims (10)

1. A molecular diagnostic centrifugation test card, comprising:

the body is provided with a sample adding cavity and a detection cavity connected with the sample adding cavity; and

the lid, the lid is established on the application of sample chamber, just the lid is including the ventilative structure that blocks water.

2. The molecular diagnostic centrifugation test card of claim 1,

the water-blocking and air-permeable structural member is provided with at least one hole, and the aperture of each hole is smaller than 100 mu m.

3. The molecular diagnostic centrifugation test card of claim 1, wherein the cover further comprises a fixture, the water-blocking air-permeable structure being connected to the fixture.

4. The molecular diagnostic centrifugation test card of claim 3, wherein the fixing member is in a hollow cylinder shape, and the water-blocking and air-permeable structure is connected to an inner peripheral wall or an end portion of the fixing member.

5. The molecular diagnostic centrifugation test card of claim 3, wherein the sample application chamber has an open end, the number of the water-blocking and air-permeable structures is one, and the fixing member comprises:

the first connecting cylinder is provided with a first end and a second end opposite to the first end, the first end is connected with the open end of the sample adding cavity, and the second end is far away from the open end;

the first assembling plate is connected to the second end of the first connecting cylinder and provided with a first assembling hole, and the water-blocking breathable structural component is assembled in the first assembling hole.

6. The molecular diagnostic centrifugation test card of claim 3, wherein the sample application chamber has an open end, the number of water-blocking and air-permeable structures is two, and the fixing member comprises:

the first connecting cylinder is provided with a first end and a second end opposite to the first end, the first end is connected with the open end of the sample adding cavity, and the second end is far away from the open end;

the first assembling plate is connected with the first connecting cylinder, a first assembling hole is formed in the first assembling plate, and one of the two air blocking and ventilating structures is assembled in the first assembling hole;

a second connector barrel connected with the second end of the first connector barrel;

the second assembly plate is connected to the end, far away from on the second connecting cylinder, of the first connecting cylinder, the second assembly plate is provided with a second assembly hole, and the other of the water-blocking and air-permeable structural members is assembled on the second assembly hole, and a cavity is formed between the first assembly plate and the second assembly plate.

7. The molecular diagnostic centrifugation test card of claim 6, wherein a distance between a surface of the first mounting plate distal to the open end of the sample addition chamber and the second mounting plate is greater than a distance between a surface of the first connector barrel at the second end and the second mounting plate.

8. The molecular diagnostic centrifugation test card of claim 6,

the first end of the first connecting cylinder is connected with the open end of the sample adding cavity in an interference fit, spiral, buckle or elastic tight fit mode; and/or

The second connecting cylinder is connected with the second end in an interference fit mode, a spiral mode, a buckling mode or an elastic tight-fitting mode.

9. The molecular diagnostic centrifugation test card of claim 1, wherein the sample application cavity comprises an open end near one side of the cover body, the open end protrudes out of the body, and the cover body abuts against the inner circumference or the outer circumference of the open end of the sample application cavity.

10. The molecular diagnostic centrifugation test card of claim 1, wherein the body comprises a base body and a cover layer, the sample application cavity and the detection cavity are arranged on the base body, the base body is further provided with a waste liquid cavity and a flow channel, the flow channel connects the sample application cavity and the waste liquid cavity, and the cover layer is connected to the surface of the base body and covers the detection cavity, the waste liquid cavity and the flow channel.

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