Detection card

Abstract

The invention relates to a detection card, and relates to the field of biological medicine detection, and the detection card comprises a detection card main body which comprises a sample adding area, a micro-channel, a detection area and an exhaust area which are communicated in sequence; the driving part comprises a pressurizing part and a connecting part, the driving part is connected with the sample adding area through the connecting part, and the pressurizing part can apply pressure to the sample adding area through deformation to drive the to-be-detected object to flow from the sample adding area to the detection area. The detection card is simple in structure, small in size, low in production cost, easy to process and manufacture, capable of realizing trace detection of various biochemical indexes, and suitable for personal self-test.

Description

Technical Field

[0001] The present invention relates to the field of biomedical testing, and in particular to a testing card. Background Art

[0002] In the field of biomedical testing, microfluidics technology integrates multiple functions on a single microchip, realizing an integrated process of sample processing, biochemical reaction and testing, greatly improving the speed and accuracy of diagnosis, while reducing the required sample volume and reagent consumption. This technology is particularly suitable for point-of-care testing (POCT), making it possible to quickly diagnose diseases on site, providing timely and effective support for clinical decision-making.

[0003] Although microfluidic technology has shown many advantages in the field of in vitro diagnostics, it also has some shortcomings, including high cost and difficulty in popularization due to technical complexity, high difficulty in processing microfluidic detection chips, the stability and repeatability of finished products needs to be improved, and high production and use costs. Summary of the invention

[0004] In view of the above problems, the present invention provides a detection card, which has a simple structure, a small size, a low production cost, is easy to process and manufacture, can realize trace detection of multiple biochemical indicators, and is suitable for personal self-testing.

[0005] In order to achieve the above object, the present invention provides a detection card, comprising:

[0006] The test card body includes a sample adding area, a microfluidic channel, a test area, and an exhaust area which are connected in sequence; and

[0007] The driving member includes a pressurizing part and a connecting part. The driving member is connected to the sample adding area through the connecting part. The pressurizing part can apply pressure to the sample adding area through deformation to drive the sample to be tested to flow from the sample adding area to the detection area.

[0008] The design of the two independent areas of the sample loading area and the detection area makes it possible to carry out two independent reactions in the detection card. The two independent areas can be used as distinguishing functional areas for the first step of pre-amplification and the second step of reporting detection, respectively. Therefore, the detection card can be applied to a two-step reaction system of amplification followed by detection, and a one-step reaction system in which amplification and detection are simultaneously carried out in the detection area. After the connection part is connected to the sample loading area, a sealed connection is formed between the driving part and the sample loading area. The user can apply a force to the pressurizing part to cause it to deform, thereby forming a positive pressure on the sample loading area, thereby driving the liquid in the sample loading area to move toward the detection area.

[0009] In one embodiment, the deformation is an inelastic strain.

[0010] To prevent the liquid from flowing back, the deformation of the pressurizing part is an irreversible deformation. It can be understood that those skilled in the art can achieve the above-mentioned inelastic strain by selecting the material formulation for preparing the pressurizing part.

[0011] In one embodiment, the inelastic strain includes at least one of plastic strain, viscous strain, and elastic-plastic strain.

[0012] In one embodiment, the pressurizing portion is a convex structure or a planar structure.

[0013] When the above-mentioned pressure-applying part is a convex structure, the force is applied to the convex structure, causing the volume of the convex part to shrink and deform; when the above-mentioned pressure-applying part is a planar structure, the force is applied to the planar structure, causing the pressure-applying part to deform into a concave shape.

[0014] In one of the embodiments, a small hole is provided on the top of the pressurizing part, and the inner surface of the small hole is sealed and connected to the waterproof breathable membrane.

[0015] The small hole provided in the pressurizing part can be more conducive to the balance of internal and external pressures after the pressurizing part is connected to the main body of the test card. At the same time, when the operator needs to use it, he can block the small hole with his finger and press down, and the internal liquid flow can also be driven by deformation. In addition, in order to prevent the reagents and test objects in the sample adding cavity from splashing out from the small hole to pollute the outside world, or the outside world from causing aerosol pollution to the reagents and test objects in the sample adding cavity, a waterproof breathable membrane can be further sealed and connected on the inner surface of the small hole, so as to achieve the balance of internal and external air pressures and prevent the liquid and the outside world from contaminating each other.

[0016] In one embodiment, the detection card body is in the shape of a plate or a sheet.

[0017] The above structural design is conducive to the flat placement of the test card body, increases stability, and facilitates sample addition and other sample or actual operations. It does not require the assistance of operating questions or other devices, can reduce the difficulty of operations such as sample addition or reagent addition, and is convenient for non-medical practitioners and ordinary people without professional training to operate and use.

[0018] In one embodiment, the detection card further includes a flow blocking component, which includes a support member and a flow blocking device. The support member is used to provide a supporting force to offset the force that produces the deformation, and the flow blocking device is arranged in the microchannel.

[0019] The above-mentioned support member can prevent the user's misoperation, extrusion damage during non-detection time periods such as transportation or sales, thereby preventing the pressure-applying part from deforming at the wrong time. The cooperation between the above-mentioned flow-blocking device and the microfluidic channel can make the liquid flowing through the inside flow in an orderly and controllable manner. Only when the deformation of the pressure-applying part provides sufficient positive pressure can the liquid pass through the flow-blocking device and enter the detection area, and the liquid can be mixed in the process of flowing through the microfluidic channel.

[0020] In one embodiment, the pressurizing portion and the connecting portion enclose a pressurizing cavity.

[0021] In one embodiment, the support member is externally mounted on the driving member, and the support member is detachably connected to the driving member;

[0022] Or the support member is located in the pressurized cavity, and the support member includes a support portion and a column, and the support portion matches the pressurized portion; the column is a hollow structure, and the support portion and the column enclose a support cavity.

[0023] When the support member is sleeved on the periphery of the driving member, the reagent and the desiccant can be pre-packaged in the space formed by the pressurized cavity and the sample loading area. The design of the pressurized cavity can pre-set the reagent inside the test card and ensure that the movable space of the pre-set reagent is very small, so as to facilitate the integrated sale and transportation of the reagent and the test card. At the same time, the pressurized cavity can also be built with a desiccant to keep the pre-set reagent dry, which is convenient for long-term storage and transportation. The support member can be a hard shell of any shape. In non-testing situations such as selling and transporting, the hard support member can provide sufficient support force to resist external pressure and avoid external force acting on the pressurized part of the driving member, causing it to deform at an inappropriate time point; when the user needs to perform a test, the support member is removed, the driving member is disassembled, and operations such as sample loading are performed, and then the driving member is installed, and a force is applied to the pressurized part to cause it to deform. The deformation forms pressure in the sample loading area, driving the object to be tested to flow from the sample loading area to the test area.

[0024] When the support member is arranged inside the driving member, the support member provides supporting force to the pressurizing part through the supporting part whose shape matches that of the pressurizing part, thereby offsetting the force applied to the pressurizing part by the outside world, and avoiding the external force acting on the pressurizing part and causing deformation at an inappropriate time during non-testing situations such as selling and transportation; when the user needs to perform a test, the driving member is disassembled, the support member is removed, and operations such as sample loading are performed, and then the driving member is installed, and a force is applied to the pressurizing part to cause it to deform. The deformation forms pressure in the sample loading area, driving the object to be tested to flow from the sample loading area to the test area.

[0025] When the support member is disposed inside the driving member, the reagent or desiccant can be pre-packaged in the space formed by the support cavity and the sample loading area. The design of the support cavity can pre-place the reagent inside the test card and ensure that the movable space of the pre-placed reagent is very small, thereby facilitating the integrated sale and transportation of the reagent and the test card. At the same time, the support cavity can also be built with a desiccant to keep the pre-placed reagent dry, which is convenient for long-term storage and transportation.

[0026] In one embodiment, the detection card body includes a sample loading surface and a heating surface, the sample loading area includes a sample loading cavity, the sample loading cavity is provided with a sample loading port facing the sample loading surface, and the sample loading port is connected to the connecting portion;

[0027] 1.2 times the volume of the microfluidic channel ≤ the volume of the deformation ≤ 2 times the volume of the microfluidic channel;

[0028] The bottom of the sample adding cavity is located on the heated surface, and the bottom of the sample adding cavity is a membrane structure.

[0029] The above-mentioned proportional design of deformation and microchannel volume can, when a force is applied to the pressurizing part to cause it to deform, the driving force generated by the deformation can push the object to be tested in the sample adding area into the microchannel, and due to the design of the deformation volume, the volume of liquid entering the microchannel is excessive and sufficient to fill the microchannel and the detection cavity, and at the same time a certain positive pressure can be reserved to ensure that the liquid does not flow back. Moreover, the driving force generated by the deformation will not be too large to cause the liquid to break through the structure of the exhaust area.

[0030] The bottom of the sample loading chamber is a membrane structure, which has a very significant heating mode advantage. First, the heat conduction efficiency is faster and more efficient, so the heating efficiency of the test sample or reagent is also greatly improved, further improving the reagent reaction efficiency. Secondly, the membrane structure is used to make the test card convenient for the heating process during the test. It not only improves the heating efficiency while ensuring the sealing, but also has a simple design and is easy to produce. The heating module of the corresponding instrument is also very simple and compact, which not only makes the cost of the test card extremely low, but also greatly reduces the volume and cost of the supporting instruments.

[0031] In one embodiment, the sample loading port protrudes from the sample loading surface.

[0032] The edge of the sample adding port protrudes from the sample adding surface and is at a certain distance from the sample adding surface, and is the adding port for the sample to be tested.

[0033] In one embodiment, the column is inserted into the sample injection port.

[0034] In one of the embodiments, the sample loading port is provided with a sample loading thread and a plurality of sample loading buckles, and the sample loading buckle is located on the side of the sample loading thread close to the sample loading surface; the connecting portion is provided with a driving thread and a plurality of driving buckles, and the driving buckle is located on the side of the driving thread close to the sample loading surface; the sample loading thread matches the driving thread, and the sample loading buckle matches the driving buckle.

[0035] The cooperation between the sample adding thread, sample adding buckle, driving thread and driving buckle enables the driving member to be attached to the detection card body by threaded connection during the non-detection time period, which is convenient for carrying. It can be understood that when the support member is arranged at the periphery of the driving member, during the non-detection time period, the driving member is directly threadedly connected to the detection card body but not screwed to the bottom. In the case of the support member providing external protection, the driving member can maintain the state of spiral connection with the detection card body, but will not contact the buckle structure located at the sample adding port; when the support member is arranged inside the driving member, because the support member provides support force inside and resists the driving member, the driving member can maintain the state of spiral connection with the detection card body, but will not contact the buckle structure located at the sample adding port. During the detection period, the user removes the support member and performs experimental operations such as adding samples and reagents. Regardless of whether the support member is arranged outside the driving member or inside the driving member, since there is no obstruction of the support member, the user can tighten the driving member all the way down to the bottom of the sample addition port by twisting it, so that the driving buckle of the driving member contacts the sample addition buckle of the sample addition port, forming a self-locking structure that cannot be opened a second time and is completely sealed. The self-locking structure can ensure the safety of the object to be tested during the detection process and avoid aerosol contamination. It can also prevent the object to be tested and reaction reagents in the detection card from leaking out and polluting the external environment.

[0036] It can be understood that the sample adding thread and the sample adding buckle can be designed on the outer surface of the sample adding port, the inner surface of the sample adding port can be designed to be smooth, and the driving thread and the driving buckle can be designed on the inner surface of the connecting part; or the sample adding thread and the sample adding buckle can also be designed on the inner surface of the sample adding port, and the driving thread and the driving buckle can be designed on the outer surface of the connecting part.

[0037] In one embodiment, the sample loading buckles are evenly distributed along the outer circumference of the sample loading port, and intervals are provided between the sample loading buckles; the drive buckles are evenly distributed along the inner circumference of the connecting portion, and intervals are provided between the drive buckles.

[0038] In one embodiment, the support member further includes a support wall, the support wall surrounds the outer circumference of the column, one end of the support wall is connected to the column, and the other end of the support wall is used to abut against the inner wall of the driving member.

[0039] When the support member is arranged inside the driving member, the support member can also be provided with a support wall, which can assist the support member by abutting against the inner wall of the driving member to further provide supporting force, thereby preventing the driving buckle of the driving member from contacting the sample loading buckle of the sample loading port during the non-detection period due to excessive screwing when the driving member is connected to the sample loading port through a thread, thereby preventing the driving buckle of the driving member from contacting the sample loading buckle of the sample loading port during the non-detection period and then being locked.

[0040] In one embodiment, the detection area includes a plurality of detection cavities, the bottom of each detection cavity is a membrane structure, and the bottom of each detection cavity is located on the heated surface.

[0041] The bottom of the above-mentioned detection cavity is a membrane structure, which has a very significant heating mode advantage. First, the heat conduction efficiency is faster and more efficient, so the heating efficiency of the detection sample or reagent is also greatly improved, further improving the reagent reaction efficiency. Secondly, the use of a membrane structure makes the detection card convenient for the heating process during the detection process. It not only improves the heating efficiency while ensuring the sealing, but also has a simple design and is easy to produce. The heating module of the corresponding instrument is also very simple and compact, which not only makes the detection card extremely low in cost, but also greatly reduces the size and cost of the supporting instruments.

[0042] In one embodiment, the detection area includes two detection cavities, and the cross-section of the detection cavity is circular or quasi-circular.

[0043] The detection cavity can be used to contain the object to be detected for detection, and can also be used to place reagents in advance.

[0044] In one embodiment, the microfluidic channel includes a main microfluidic channel and several branch microfluidic channels, one end of the main microfluidic channel is connected to the sample loading area, and the other end of the main microfluidic channel is connected to the branch microfluidic channel; the bottom of the detection chamber is connected to the branch microfluidic channel, and the top of the detection chamber is connected to the exhaust area.

[0045] The connection positions of the above-mentioned detection chamber with the branch microchannel and the exhaust area are arranged in a diagonal manner, one down and one up, so that the liquid enters the detection chamber from the bottom and the gas gathered in the upper part of the detection chamber is discharged from the top of the detection chamber, which can effectively realize the filling of the liquid and the removal of excess gas and bubbles entrained in the liquid.

[0046] In one embodiment, the cavity top of the detection cavity is a membrane structure, and the cavity top of the detection cavity is located on the sample loading surface.

[0047] In one embodiment, the flow blocking device is disposed in the main microchannel.

[0048] In one embodiment, the flow blocking device includes a plurality of flow blocking members.

[0049] In one embodiment, the flow blocking member is a liquid blocking valve.

[0050] In one embodiment, the flow blocking device includes three liquid blocking valves, and the liquid blocking valves are arranged in series in the main microchannel.

[0051] The above-mentioned number of liquid-blocking valves form a triple barrier effect on the liquid flowing into the microchannel, and sufficient barrier effect is used to prevent the liquid from flowing into the detection area at an inappropriate time point.

[0052] In one embodiment, the flow blocking device includes three flow blocking members, and the flow blocking members include porous materials.

[0053] The above-mentioned porous materials adjust the interception effect by adjusting the hydrophilicity and hydrophobicity and pores.

[0054] In one of the embodiments, the porous material comprises at least one of a polymer material, a porous carbon material, an inorganic material, a paper-based material, or an emulsion-based porous material.

[0055] In one embodiment, the microchannel is located on the heated surface.

[0056] In one embodiment, a liquid inlet hole is provided at the bottom of the detection chamber, and a detection exhaust hole is provided at the top of the detection chamber. The liquid inlet hole is communicated with the branch microchannel, and the detection exhaust hole is communicated with the exhaust area.

[0057] In one embodiment, the exhaust area includes a water-blocking and breathable cavity, the water-blocking and breathable cavity is provided with a water-blocking and breathable membrane, an exhaust hole, and a plurality of exhaust holes, the exhaust holes are provided at the cavity top of the water-blocking and breathable cavity, the exhaust holes are connected with the detection area, the water-blocking and breathable membrane is provided at the top of the water-blocking and breathable cavity, and the exhaust holes are used to exhaust the gas from the detection card.

[0058] One end of the exhaust hole is connected to the water-blocking and breathable cavity, and the other end is connected to the atmosphere. It is the only external ventilation channel of the entire test card after the user screws on the driving part to form a self-locking structure.

[0059] In one embodiment, the vent hole is sealed and connected to the water-blocking and breathable membrane.

[0060] In one embodiment, the water-blocking and breathable membrane is sealed and connected to the air hole by ultrasonic welding, mechanical clamping, thermal bonding, laser welding or chemical bonding.

[0061] In one embodiment, the material of the water-blocking and breathable membrane includes at least one of expanded polytetrafluoroethylene, polyester, polyurethane, and polyethylene.

[0062] In one embodiment, the top of the water-blocking and air-permeable cavity is close to the sample application surface, the bottom of the water-blocking and air-permeable cavity is located at the heating surface, and the bottom of the water-blocking and air-permeable cavity is a membrane structure.

[0063] In one embodiment, the air vent is connected to the detection exhaust hole.

[0064] In one embodiment, the material of the test card includes at least one of polydimethylsiloxane, polymethyl methacrylate, polycarbonate, polystyrene, polypropylene, polytetrafluoroethylene, cyclic olefin copolymer, and cyclic olefin polymer.

[0065] In one embodiment, the detection card body further includes a handle, which is disposed at one end close to the sample loading area.

[0066] The design of the handle is convenient for users to operate manually.

[0067] In one embodiment, a direction indicating pattern is provided on the surface of the handle.

[0068] The above-mentioned direction indication pattern facilitates the user to quickly understand the process flow of the test card including adding the sample, flowing through the microchannel, and observing the test results.

[0069] Compared with the prior art, the present invention has the following beneficial effects:

[0070] A test card of the present invention has a simple structure, a compact size, a low production cost, is easy to process and manufacture, can realize trace detection of multiple biochemical indicators, and is suitable for personal self-testing and home self-testing. The test card has a design of two independent areas, namely, a sample addition area and a detection area, so that two independent reactions can be carried out in the test card. The two independent areas can be used as distinguishing functional areas for the first step of pre-amplification and the second step of report detection, respectively. Therefore, the test card can be applied to a two-step reaction system of amplification before detection, and can also be applied to a one-step reaction system of amplification and detection simultaneously performed in the detection area. After the above-mentioned connecting part is connected to the sample addition area, a sealed connection is formed between the driving part and the sample addition area. The user can apply a force to the pressurizing part to cause it to deform, and then form a positive pressure on the sample addition area, thereby driving the liquid in the sample addition area to move toward the detection area. BRIEF DESCRIPTION OF THE DRAWINGS

[0071] Figure 1 Schematic diagram of inserting the test card into the tester;

[0072] Figure 2 This is a schematic diagram of the detection card;

[0073] Figure 3 Provide an exploded view of the test card structure;

[0074] Figure 4 It is a schematic diagram of the detailed features of the detection card body;

[0075] Figure 5 It is a top view of the detailed features of the main body of the detection card;

[0076] Figure 6 It is a schematic diagram and a cross-sectional diagram of a driving member;

[0077] Figure 7 It is a schematic diagram and a cross-sectional view of a support member;

[0078] Figure 8 is a schematic diagram of the detector;

[0079] Fig. 9 An exploded diagram of the detector structure;

[0080] Among them, 1 is a detection card, 11 is a detection card body, 111 is a sample loading chamber, 1111 is a sample loading chamber bottom, 112 is a sample loading port, 1121 is a sample loading thread, 1122 is a sample loading buckle, 113 is a main microchannel, 114 is a branch microchannel, 115 is a detection chamber, 1151 is an exhaust channel, 116 is a water-blocking and breathable chamber, 1161 is a water-blocking and breathable membrane, 1162 is an exhaust hole, 1163 is an air hole, 1 17 is a sample adding surface, 118 is a heating surface, 119 is a handle, 14 is a direction indicating pattern, 15 is a positioning hole, 16 is a sealing film, 12 is a driving member, 121 is a pressurizing portion, 122 is a connecting portion, 1221 is a driving thread, 1222 is a driving buckle, 131 is a supporting member, 1311 is a supporting portion, 1312 is a column, 1313 is a supporting wall, 1314 is a supporting cavity, and 1321 is a liquid blocking valve;

[0081] 2 is a detector, 21 is a shell, 211 is a button, 212 is an indicator light, 213 is a power socket, 214 is a detection card socket, 215 is an upper shell, 216 is a lower shell, 22 is a main board, 23 is a light source board, and 24 is a heating board. DETAILED DESCRIPTION

[0082] In order to facilitate the understanding of the present invention, the present invention will be described more fully below with reference to the relevant drawings. The preferred embodiments of the present invention are given in the drawings. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the understanding of the disclosure of the present invention more thorough and comprehensive.

[0083] It should be noted that when an element is referred to as being "fixed to" another element, it may be directly on the other element or there may be an intermediate element. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be an intermediate element at the same time.

[0084] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used in the specification of the present invention herein are only for the purpose of describing specific embodiments and are not intended to limit the present invention.

[0085] Unless otherwise specified, the reagents, materials, and equipment used in this example are all commercially available; the experimental methods are all conventional experimental methods in the art unless otherwise specified.

[0086] Example 1

[0087] A detection card and a matching detection instrument.

[0088] 1. A test card.

[0089] The detection card 1 comprises a detection card body 11 , a driving member 12 , and a flow blocking component.

[0090] The test card body 11 includes a handle 119, a positioning hole 15, a sample adding area, a microchannel, a test area, and an exhaust area connected in sequence. The material of the test card body 11 includes at least one of polydimethylsiloxane, polymethyl methacrylate, polycarbonate, polystyrene, polypropylene, polytetrafluoroethylene, cyclic olefin copolymer, and cyclic olefin polymer.

[0091] The driving member 12 includes a pressurizing portion 121 and a connecting portion 122. The driving member 12 is connected to the sample loading area via the connecting portion 122. The pressurizing portion 121 and the connecting portion 122 enclose a pressurizing cavity. The pressurizing portion 121 of the driving member 12 can be deformed under the action of an external force. The volume change brought about by the deformation can apply pressure to the sample loading area, driving the object to be tested located in the sample loading area to flow to the detection area.

[0092] It can be understood that in order to prevent the liquid from flowing back, the above-mentioned deformation is a non-elastic strain (for example, plastic strain, viscous strain, elastic-plastic strain); the above-mentioned pressurizing part 121 can be designed as a convex structure or a planar structure. When the pressurizing part 121 is a convex structure, the force is applied to the convex structure to reduce the volume of the convex part and produce deformation; when the pressurizing part 121 is a planar structure, the force is applied to the planar structure to cause the pressurizing part 121 to produce a concave deformation.

[0093] Furthermore, a small hole can also be provided on the top of the pressurizing part 121, and the inner surface of the small hole is sealed and connected to a waterproof breathable membrane. The small hole provided on the pressurizing part 121 can be more conducive to the balance of internal and external pressures after the pressurizing part is connected to the detection card body 11. At the same time, when the operator needs to use it, he can block the small hole with his fingers and press down, and can also drive the internal liquid flow through deformation. In addition, in order to avoid the reagents, the objects to be tested, etc. in the sample adding chamber 111 from splashing out from the small hole to pollute the outside world, or the outside world causing aerosol pollution to the reagents, the objects to be tested, etc. in the sample adding chamber 111, a waterproof breathable membrane can be further sealed and connected to the inner surface of the small hole, so as to achieve the balance of internal and external pressures and prevent the liquid and the outside world from contaminating each other.

[0094] The flow blocking assembly includes a support member 131 and a flow blocking device, and the flow blocking device is arranged in the microchannel; the support member 131 can be externally mounted on the driving member 12 and detachably connected to the driving member 12, and can also be arranged inside the driving member 12.

[0095] When the support member 131 is sleeved on the periphery of the driver 12, the support member 131 can be a hard shell of any shape. In non-testing situations such as selling and transporting, the hard support member 131 can provide sufficient support force to resist external pressure and prevent external force from acting on the pressurizing part 121 of the driver 12, causing it to deform at an inappropriate time point; when the user needs to perform a test, the support member 131 is removed, the driver 12 is disassembled, and operations such as adding samples are performed, and then the driver 12 is installed, and a force is applied to the pressurizing part 121 to cause it to deform. The deformation forms pressure in the sample adding area, driving the object to be tested to flow from the sample adding area to the test area. In addition, in the non-testing time period, the driver 12 can be directly threadedly connected to the test card body 11 but not screwed to the bottom. In the case of external protection provided by the support member 131, the driver 12 can remain in a state of being spirally connected to the test card body 11, but will not contact the buckle structure located at the sample adding port 112.

[0096] When the support member 131 is arranged inside the driving member 12, the support member 131 provides a supporting force to the pressurizing part 121 through the support part 1311 arranged inside the pressurizing part, thereby offsetting the force applied to the pressurizing part 121 by the outside world, and avoiding the external force acting on the pressurizing part 121 in non-testing situations such as selling and transportation, causing it to deform at an inappropriate time point; when the user needs to perform a test, the driving member 12 is disassembled, the support member 131 is removed, and the sample is added, and then the driving member 12 is installed, and a force is applied to the pressurizing part 121 to cause it to deform, and the deformation forms pressure in the sample addition area, driving the object to be tested to flow from the sample addition area to the test area. When the support member 131 is arranged inside the driving member 12, because the support member 131 provides a supporting force inside and resists the driving member 12, the driving member 12 can remain in a spiral connection with the test card body 11, but will not contact the buckle structure located at the sample addition port 112.

[0097] During the detection period, the user removes the support member 131 and performs experimental operations such as adding samples and reagents. Regardless of whether the support member 131 is arranged outside the driving member 12 or inside the driving member 12, since there is no obstruction of the support member 131, the user can tighten the driving member 12 downward to the bottom of the sample addition port 112 by twisting it, so that the driving buckle 1222 of the driving member 12 contacts the sample addition buckle 1122 of the sample addition port 112, forming a self-locking structure that cannot be opened a second time and is completely sealed. The self-locking structure can ensure the safety of the object to be tested during the detection process and avoid aerosol contamination. It can also prevent the object to be tested and reaction reagents in the detection card 1 from leaking out and polluting the external environment.

[0098] In this embodiment, the pressurizing part 121 is located at the top of the driving member 12 and protrudes outward, so that the driving member 12 as a whole forms a structure similar to a cover, and the support member 131 is located in the pressurizing cavity. The support member 131 includes a support part 1311, a column 1312, and a support wall 1313. The shape of the support part 1311 matches the pressurizing part 121. The column 1312 is a hollow structure that can be plugged into the sample injection port 112. The support part 1311 and the column 1312 enclose a support cavity 1314, which can be used to pre-place reagents, place desiccants, etc. The support wall 1313 is arranged around the outer periphery of the column 1312, one end of which is connected to the column 1312, and the other end is against the inner wall of the driving member 12.

[0099] The above-mentioned support wall 1313 can further provide supporting force by abutting against the auxiliary support member 131 with the inner wall of the driving member 12, so as to prevent the driving buckle 1222 of the driving member 12 from contacting with the sample loading buckle 1122 of the sample loading port 112 during the non-detection time period due to excessive screwing when the driving member 12 is connected to the sample loading port 112 through a thread, thereby preventing the driving buckle 1222 of the driving member 12 from contacting with the sample loading buckle 1122 of the sample loading port 112 during the non-detection time period and then being locked.

[0100] The test card body 11 can be in the form of a plate or a sheet, and the two sides of the test card 1 are respectively a sample loading surface 117 and a heating surface 118, and a handle 119 is located at one end close to the sample loading area. In this embodiment, the test card body 11 is in the form of a sheet, and a direction indicating pattern 14 is provided on the surface of the handle 119. The positioning hole 15 is used to position the test card 1 when it is inserted into the detector 2.

[0101] The sample loading area includes a sample loading cavity 111, and a sample loading port 112 is provided on one side of the sample loading cavity 111 facing the sample loading surface 117. The sample loading port 112 protrudes from the sample loading surface 117, and its edge is at a certain distance from the sample loading surface 117, and is a loading port for the sample to be tested. The sample loading port 112 is connected to the connecting portion 122. In this embodiment, the connection between the sample loading port 112 and the connecting portion 122 is threaded, and the outer wall of the sample loading port 112 is provided with a sample loading thread 1121, and the inner wall of the connecting portion 122 is provided with a driving thread 1221 matching the sample loading thread 1121. The outer wall of the sample loading port 112 is also provided with a plurality of sample loading buckles 1122, which are located on a side of the sample loading thread 1121 close to the sample loading surface 117, and the sample loading buckles 1122 are evenly distributed along the outer periphery of the sample loading port 112, and intervals are provided between the sample loading buckles 1122; the inner wall of the connecting portion 122 is also provided with a plurality of drive buckles 1222, which are located on a side of the drive thread 1221 close to the sample loading surface 117, and the drive buckles 1222 are evenly distributed along the inner periphery of the connecting portion 122, and intervals are provided between the drive buckles 1222, and the sample loading buckles 1122 are matched and snapped together with the drive buckles 1222.

[0102] The cooperation among the sample adding thread 1121, the sample adding buckle 1122, the driving thread 1221 and the driving buckle 1222 enables the detection card 1 to be attached to the detection card body 11 by means of thread connection during the non-detection period, which is convenient for carrying; and due to the obstruction of the support member 131, the driving member 12 can be connected to the sample adding port 112 by means of thread, and the driving buckle 1222 of the driving member 12 will not contact the sample adding buckle 1122 of the sample adding port 112 at the wrong time due to excessive twisting, thereby being locked; during the detection period, After the user removes the support member 131 and performs experimental operations such as adding samples and reagents, the user can screw the driving member 12 down to the bottom of the sample addition port 112 by twisting it because there is no obstruction from the support member 131, so that the driving buckle 1222 of the driving member 12 contacts the sample addition buckle 1122 of the sample addition port 112, and form a self-locking structure that cannot be opened a second time and is completely sealed. The self-locking structure can ensure the safety of the object to be tested during the detection process and avoid aerosol contamination. It can also prevent the object to be tested and reaction reagents in the detection card 1 from leaking out and polluting the external environment.

[0103] When designing the driving member 12 and the microchannel, 1.2 times the volume of the microchannel ≤ the volume of the pressurizing portion 121 that can be deformed ≤ 2 times the volume of the microchannel. In this embodiment, the volume of the pressurizing portion 121 that can be deformed is 1.5 times the volume of the microchannel.

[0104] The above-mentioned proportional design of deformation and microchannel volume can, when a force is applied to the pressurizing part 121 to cause it to deform, the driving force generated by the deformation can push the object to be tested in the sample loading area into the microchannel, and due to the design of the deformation volume, the volume of liquid entering the microchannel is excessive and sufficient to fill the microchannel and the detection chamber 115. At the same time, a certain positive pressure can be reserved to ensure that the liquid does not flow back. Moreover, the driving force generated by the deformation will not be too large to cause the liquid to break through the structure of the exhaust area.

[0105] The microfluidic channel includes a main microfluidic channel 113 and several branch microfluidic channels 114. The detection area includes several detection chambers 115. The exhaust area includes a water-blocking and air-permeable chamber 116. The sample adding chamber 111, the main microfluidic channel 113, the branch microfluidic channel 114, the detection chamber 115, and the water-blocking and air-permeable chamber 116 are connected in sequence. The branch microfluidic channel 114 corresponds to the detection chamber 115 one by one, and the flow blocking device is arranged in the main microfluidic channel 113.

[0106] The bottoms of the sample adding chamber 111 and the detection chamber 115 are both located on the heating surface 118, and are both membrane structures. The membrane structure has a very significant heating mode advantage. First, the heat conduction efficiency is faster and more efficient, so the heating efficiency of the detection sample or reagent is also greatly improved, further improving the reagent reaction efficiency. Secondly, the membrane structure is used to make the detection card 1 convenient for the heating process during the detection process. It not only improves the heating efficiency while ensuring the sealing, but also has a simple design and is easy to produce. The heating module of the corresponding instrument is also very simple and compact, which not only makes the detection card 1 extremely low in cost, but also greatly reduces the volume and cost of the supporting instruments.

[0107] It is understandable that the microchannel can be designed as a channel running through the inside of the detection card body 11, or located on the surface of the detection card body 11. In the present embodiment, the microchannel is located on the heated surface 118. The flow blocking device includes a plurality of flow blocking members, which may be a liquid blocking valve 1321 or a porous material. When the flow blocking member is a porous material, the interception effect is adjusted by adjusting the hydrophilicity and hydrophobicity and the pores, and the porous material includes at least one of a polymer material, a porous carbon material, an inorganic material, a paper-based material, or an emulsion-based porous material. In the present embodiment, the flow blocking device includes three flow blocking members, which are liquid blocking valves 1321, which are arranged in series in the main microchannel 113. The above number of liquid blocking valves 1321 form a three-fold obstruction effect on the liquid flowing into the microchannel, and sufficient obstruction is used to prevent the liquid from flowing into the detection area at an inappropriate time point.

[0108] In this embodiment, a liquid inlet hole is provided at the bottom of the detection chamber 115, and a detection exhaust hole is provided at the top. The liquid inlet hole is connected to the branch microchannel 114, and the detection exhaust hole is connected to the water-blocking and air-permeable chamber 116 through the exhaust channel 1151. The exhaust channel 1151 is provided on the sample loading surface 117. The diagonal arrangement of the liquid inlet hole and the detection exhaust hole, one below and one above, enables the liquid to enter from the bottom of the detection chamber 115 through the branch microchannel 114, and the gas in the detection chamber 115 and the bubbles entrained in the liquid are discharged from the detection exhaust hole at the top of the detection chamber 115, which can effectively realize the filling of the liquid and the removal of the bubbles entrained in the excess gas and liquid.

[0109] The water-blocking and breathable cavity 116 is provided with an exhaust hole 1162, one end of which is connected to the water-blocking and breathable cavity 116, and the other end is connected to the atmosphere, for exhausting the gas from the detection card 1. The water-blocking and breathable cavity 116 is also provided with a water-blocking and breathable membrane 1161 and a plurality of breathable holes 1163. The breathable holes 1163 are connected to the detection exhaust holes through the exhaust channel 1151. The water-blocking and breathable membrane 1161 is fixedly connected to the breathable holes 1163 to form a seal. Through the cooperation of the breathable holes 1163 and the water-blocking and breathable membrane 1161, the liquid is blocked and cannot pass through the breathable holes 1163, while ensuring that the detection cavity 115 is filled with liquid. The material of the water-blocking and breathable membrane 1161 includes at least one of expanded polytetrafluoroethylene, polyester, polyurethane, and polyethylene. The water-blocking and breathable membrane 1161 is preferably fixed by ultrasonic welding, and can also be fixed by other forms, such as mechanical clamping, thermal bonding, laser welding, chemical bonding, etc.

[0110] In this embodiment, the vent hole 1162 is arranged at a side away from the sample injection port 112. After the user screws on the driving member 12 to form a self-locking structure, the vent hole 1162 is the only external ventilation channel of the entire detection card 1. The air hole 1163 is arranged at the top of the water-blocking and air-permeable cavity 116, and the water-blocking and air-permeable membrane 1161 is arranged at the top of the water-blocking and air-permeable cavity 116.

[0111] It can be understood that when preparing the above-mentioned test card 1, in order to facilitate processing, the cavity bottom 1111 of the sample adding cavity, the microchannel, the cavity bottom of the detection cavity 115, and the cavity bottom of the water-blocking and air-permeable cavity 116 are all located on the heating surface 118, and the cavity top of the detection cavity 115, the exhaust channel 1151, and the air holes 1163 are all located on the sample adding surface 117. During the preparation process, by attaching the sealing film 16 to the two sides of the detection card body 11, the microchannel, the cavity top of the detection cavity 115, the exhaust channel 1151, the cavity bottom of the water-blocking and air-permeable cavity 116, and the air holes 1163 can be closed to achieve the airtightness of the test card 1; and the membrane structure cavity bottom of the sample adding cavity 111 and the detection cavity 115 can be formed simultaneously, so that the two independent reaction areas of the test card 1 have very significant heating mode advantages.

[0112] In this embodiment, the schematic diagram of the test card 1 inserted into the tester 2 is as follows: Figure 1 As shown, the test card 1 is as Figure 2 As shown, the structure of the test card 1 is as follows Figure 3 As shown, the structure of the detection card body 11 is as follows Figure 4 , Figure 5 As shown, the structure of the driving member 12 is as follows Figure 6 As shown, the structure of the support member 131 is as follows Figure 7 shown.

[0113] The sealing film 16 can be made of a plastic film, the raw material of which includes at least one of polyester, polyethylene terephthalate, polycarbonate, polypropylene and polymethyl methacrylate. The sealing film 16 bonded to the sample adding surface 117 and the heating surface 118 of the detection card body 11 can be made of the same material or different materials. The sealing film 16 and the detection card body 11 can be bonded by single-sided adhesive, ultrasonic welding, thermal bonding, laser welding or chemical bonding.

[0114] 2. Detector.

[0115] The detector 2 includes a housing 21 and a light source board 23, a heating board 24, and a main board 22 installed inside the housing 21. The light source board 23 and the heating board 24 are connected to the main board 22 through wires. The outer surface of the housing 21 is provided with a button 211, an indicator light 212, a power socket, and a detection card socket 214.

[0116] The above-mentioned button 211 is an operation button and has an anti-accidental touch function; the above-mentioned indicator light 212 includes a status indicator light and a result indicator light, which respectively have the functions of indicating the instrument operation status and reporting the positive and negative results; the above-mentioned power socket 213 is used for power insertion and connection with the mainboard 22 to provide power for the detector 2, and can be designed as a Type-C interface; the above-mentioned test card socket 214 is used to insert and fix the test card 1, and the heating plate 24 is located below the test card socket 214.

[0117] In the embodiment, the shell 21 is divided into an upper shell 215 and a lower shell 216. The button 211 and the indicator light 212 are arranged on the outer surface of the upper shell 215. The light source board 23 is fixedly connected to the upper shell 215; the heating plate 24 and the main board 22 are fixedly connected to the lower shell 216; the upper shell 215 and the lower shell 216 can be fixedly connected by screws or snaps to form a complete detector shell 21.

[0118] The light source board 23 is a circuit board designed according to product requirements, and is mainly used to provide an excitation light source for the reagent reaction in the detection card 1. The appropriate wavelength can be replaced according to different detection scenarios.

[0119] The main board 22 is a circuit board designed according to product requirements. It is the detection and control center of the detector 2. It is used to collect the light signals that change during the reagent reaction process, amplify and convert the real-time light signals into analog-to-digital signals, and finally complete the data calculation and processing through a microprocessor.

[0120] The heating plate 24 is used to provide a constant temperature for the test card 1 so that the reagents can react biochemically at a suitable temperature. In normal use, the upper surface of the heating plate 24 is in close contact with the lower surface of the test card 1. The temperature control range is between room temperature and 100°C, and the control accuracy is ±0.1°C. One or more filter elements are arranged in the heating plate 24 to filter out the interference of optical signals in the non-detection wavelength band.

[0121] In this embodiment, the detector 2 is as follows Figure 8 As shown, the structure of the detector 2 is as follows Fig. 9 shown.

[0122] In this embodiment, the detector 2 is a small handheld instrument with a simple structure, a compact size, and a weight of no more than 40g. The instrument is very simple and only requires one button 211 for operation. The indicator light 212 can display the test results within a few minutes, and the user can easily understand it without professional knowledge. While ensuring high performance, the detector 2 also achieves the goal of extremely low cost, and is not only suitable for medical institutions, but also suitable for use in schools, communities, and homes.

[0123] Experimental Example 2

[0124] The detection card 1 and the detection instrument 2 in Example 1 are used for detection.

[0125] 1. Power on the instrument: Place the detector 2 on the table and connect the power cord to the power socket. Power on the instrument, all indicator lights flash three times, and then the detector 2 starts self-testing and preheating;

[0126] 2. Instrument preparation: Wait for the detector 2 to pass the self-test and complete the preheating, the Test indicator light will be on, and the instrument is ready;

[0127] 3. Preparation of the test card 1: Place the test card 1 flat on the table, open the drive member 12, take out the support member 131, and add a certain amount of the sample to be tested; re-cover the drive member 12, turn its knob to the bottom, so that the drive buckle 1222 of the drive member 12 contacts the sample adding buckle 1122 of the sample adding port 112 and forms a self-locking structure to ensure complete sealing; fully press the convex pressurizing part 121 above the drive member 12; the liquid moves to the detection chamber 115 through the main microchannel 113 and the branch microchannel 114 due to the pressure, and due to the effect of the water-blocking and breathable membrane 1161 (gas passes, liquid is blocked), the liquid is finally blocked and cannot pass through the vent 1163. At this time, the detection chamber 115 is completely filled with liquid;

[0128] 4. Loading the test card 1: inserting the prepared test card 1 containing the sample into the test card socket 214 of the detector 2;

[0129] 5. Start the test: Click the button 211, and after a short buzzer sound, the detector 2 starts the test; the detector 2 heats the bottom of the test card 1, and the liquid and the freeze-dried reagent pre-placed in the test cavity 115 begin to react;

[0130] 6. Reporting results: The detector 2 monitors the signal changes in the detection chamber 115. After waiting for a certain period of time, the detector 2 ends the detection, and the indicator light reports the test results, such as positive, negative, invalid, etc. At the same time, the corresponding indicator light will light up;

[0131] End shutdown: Pull out the test card 1 from the detector 2, unplug the power cord and the detector 2 will automatically shut down.

[0132] Example 3

[0133] The detection card 1 and the detection instrument 2 in Example 1 are used for detection.

[0134] 1. Power on the instrument: Place the detector 2 on the table and connect the power cord to the power socket. Power on the instrument, all indicator lights flash three times, and then the detector 2 starts self-testing and preheating;

[0135] 2. Instrument preparation: Wait for the detector 2 to pass the self-test and complete the preheating, the Test indicator light will be on, and the instrument is ready;

[0136] 3. Preparation of the test card 1: Place the test card 1 flat on the table, open the driving member 12, take out the supporting member 131, and add a certain amount of the sample to be tested; re-cover the driving member 12, turn its knob to the bottom, so that the driving buckle 1222 of the driving member 12 and the sample adding buckle 1122 of the sample adding port 112 form a self-locking structure to ensure complete sealing;

[0137] 4. Loading the test card 1: inserting the prepared test card 1 containing the sample into the test card socket 214 of the detector 2;

[0138] 5. Start the test: Click the button 211, and after a short buzzer sound, the detector 2 starts the test; the bottom of the detector 2 heater 1 starts the first stage of the reaction between the sample and the freeze-dried reagent in the sample port 112 of the test card;

[0139] 6. Secondary operation of the test card: After waiting for the reminder from the detector 2, fully press the convex pressurizing part 121 above the driving member 12. Due to the pressure, the liquid moves to the test cavity 115 through the main microchannel 113 and the branch microchannel 114. Due to the effect of the water-blocking and breathable membrane 1161 (the gas passes, the liquid is blocked), the liquid is finally blocked and cannot pass through the breathable hole 1163. At this time, the test cavity 115 is completely filled with liquid.

[0140] 7. Secondary operation of instrument buttons: Press the button of detector 2 again, and detector 2 starts the next process; detector 2 heats the bottom of detection card 1 again, and the liquid obtained by the first stage reaction and the freeze-dried reagent pre-placed in the detection chamber 115 start the second stage reaction;

[0141] 8. Reporting results: The detector 2 monitors the signal changes in the detection chamber 115. After waiting for a certain period of time, the detector 2 ends the detection, and the indicator light reports the test results, such as positive, negative, invalid, etc. At the same time, the corresponding indicator light will light up;

[0142] End shutdown: Pull out the test card 1 from the detector 2, unplug the power cord and the detector 2 will automatically shut down.

[0143] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0144] The above-mentioned embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A detection card, characterized in that: include: The main body of the test card includes a sample adding area, a microfluidic channel, a test area, and an exhaust area which are connected in sequence; as well as The driving member includes a pressurizing part and a connecting part. The driving member is connected to the sample adding area through the connecting part. The pressurizing part can apply pressure to the sample adding area through deformation to drive the sample to be tested to flow from the sample adding area to the detection area.

2. The detection card according to claim 1, characterized in that: The detection card also includes a flow blocking component, which includes a support member and a flow blocking device. The support member is used to provide a supporting force to offset the force that produces the deformation, and the flow blocking device is arranged in the microchannel.

3. The detection card according to claim 1, characterized in that: The pressurizing portion and the connecting portion enclose a pressurizing cavity.

4. The detection card according to claim 3, characterized in that: The support member is externally mounted on the driving member, and the support member and the driving member are detachably connected; Or the support member is located in the pressurized cavity, and the support member includes a support portion and a column, and the support portion matches the pressurized portion; the column is a hollow structure, and the support portion and the column enclose a support cavity.

5. The test card according to any one of claims 1 to 4, characterized in that: The detection card body comprises a sample loading surface and a heating surface, the sample loading area comprises a sample loading cavity, the sample loading cavity is provided with a sample loading port facing the sample loading surface, and the sample loading port is detachably connected to the connecting portion; 1.2 times the volume of the microfluidic channel ≤ the volume of the deformation ≤ 2 times the volume of the microfluidic channel; The bottom of the sample adding cavity is located on the heated surface, and the bottom of the sample adding cavity is a membrane structure.

6. The detection card according to claim 5, characterized in that: The sample loading port is provided with a sample loading thread and a plurality of sample loading buckles, and the sample loading buckle is located on the side of the sample loading thread close to the sample loading surface; the connecting portion is provided with a driving thread and a plurality of driving buckles, and the driving buckle is located on the side of the driving thread close to the sample loading surface; the sample loading thread matches the driving thread, and the sample loading buckle matches the driving buckle.

7. The detection card according to claim 6, characterized in that: The support member further comprises a support wall, the support wall surrounds the outer periphery of the column, one end of the support wall is connected to the column, and the other end of the support wall is used to abut against the inner wall of the driving member.

8. The detection card according to claim 5, characterized in that: The detection area includes a plurality of detection cavities, the bottom of each detection cavity is a membrane structure, and the bottom of each detection cavity is located on the heated surface.

9. The detection card according to claim 8, characterized in that: The microfluidic channel includes a main microfluidic channel and several branch microfluidic channels. One end of the main microfluidic channel is connected to the sample addition area, and the other end of the main microfluidic channel is connected to the branch microfluidic channel; the bottom of the detection chamber is connected to the branch microfluidic channel, and the top of the detection chamber is connected to the exhaust area.

10. The detection card according to claim 5, characterized in that: The exhaust area includes a water-blocking and breathable cavity, which is provided with a water-blocking and breathable membrane, an exhaust hole, and a plurality of exhaust holes. The exhaust hole is provided at the top of the water-blocking and breathable cavity, and the exhaust hole is connected to the detection area. The water-blocking and breathable membrane is provided at the top of the water-blocking and breathable cavity, and the exhaust hole is used to exhaust the gas from the detection card.

Images