Human brucella igm / igg antibody fingertip blood home test colloidal gold kit

Abstract

This invention relates to the field of in vitro diagnostic testing technology, specifically disclosing a colloidal gold reagent kit for home testing of human Brucella IgM / IgG antibodies via finger-prick blood. The kit includes a shell, a gas supply device, a gas ring, a lifting device, a blood collection needle assembly, a gas regulating device, a collection chamber, a release device, a supply tube, a sample outlet tube, and a colloidal gold test card. This invention utilizes a venturi tube, a first shunt branch, a first gas guide branch, a gas buffer chamber, and a hydrophobic and breathable membrane to create a negative pressure blood collection path, allowing blood to enter the collection chamber via the supply tube. After the collection chamber is full of blood, the gas regulating device automatically switches the airflow to the release device, achieving a continuous connection between negative pressure blood collection and positive pressure release of diluent, thereby reducing the number of times the user needs to intervene repeatedly during the testing process.

Description

Technical Field

[0001] This invention relates to the field of in vitro diagnostic testing technology, specifically a colloidal gold reagent kit for home testing of human Brucella IgM / IgG antibodies via finger-prick blood. Background Technology

[0002] Brucellosis is a zoonotic infectious disease caused by Brucella bacteria. For human Brucella infection, testing for Brucella IgM and IgG antibodies in human blood samples can provide a reference for relevant screening and auxiliary diagnosis.

[0003] Colloidal gold immunochromatographic assays are relatively simple to operate, fast in speed, and do not require large instruments, making them suitable for on-site screening or home testing. Existing colloidal gold test kits for blood samples typically include a test card, lancet, blood collection tube, dropper, and diluent bottle. During the testing process, users generally need to sequentially complete the following steps: finger puncture, blood collection, blood transfer, diluent addition, sample mixing, and sample loading.

[0004] However, the above procedures remain relatively complex for home users lacking professional experience. Users need to control the amount of blood collected and the amount of diluent added, and add the blood and diluent to the test card as required. Insufficient blood collection, inaccurate diluent addition, inadequate mixing of the liquids, or deviation in the sample addition position may affect the stability of the subsequent testing process.

[0005] Meanwhile, during manual blood collection and sample transfer, blood needs to pass through lancets, blood collection tubes, droppers, or other transfer tools, increasing the chance of the sample coming into contact with the external environment. Blood, diluents, or mixed test liquids may also drip, spill, or remain, easily increasing the risk of sample contamination, environmental contamination, and cross-contamination.

[0006] Furthermore, in some existing test kits, the blood collection, dilution, and sample loading steps are independent. After blood collection, users still need to manually add diluent and transfer the sample to the testing site, making it difficult to form a continuous, closed sample processing pathway. For home testing scenarios, it is still necessary to further simplify the operation steps, reduce manual intervention, and improve the closedness and stability of the sample processing process.

[0007] Therefore, it is necessary to provide a sample processing device for home testing of human Brucella IgM / IgG antibodies via finger-prick blood to reduce manual steps in the blood collection, dilution, mixing and sample dispensing processes, reduce the risk of sample contamination, and improve the convenience of home testing. Summary of the Invention

[0008] The purpose of this invention is to provide a colloidal gold reagent kit for home detection of human Brucella IgM / IgG antibodies via finger-prick blood, in order to solve the problems mentioned in the background art.

[0009] To achieve the above objectives, the present invention provides the following technical solution: To achieve the above objectives, the present invention provides a colloidal gold reagent kit for home detection of human Brucella IgM / IgG antibodies via finger-prick blood, comprising: a collection chamber, a release device, a gas conditioning device, a supply tube, and a sample outlet tube; the supply tube is connected to the collection chamber, the sample outlet tube is connected to the collection chamber, the release device is connected to both the collection chamber and the gas conditioning device, and the gas conditioning device is connected to the collection chamber.

[0010] Preferably, the collection chamber includes: a blood collection chamber, a gas buffer chamber, a hydrophobic and breathable membrane, an auxiliary membrane, a dividing plate, and a vent hole; the blood collection chamber is disposed within the collection chamber and connected to the blood supply vessel; the gas buffer chamber is disposed within the collection chamber; the hydrophobic and breathable membrane is disposed between the blood collection chamber and the gas buffer chamber; the auxiliary membrane is disposed below the blood collection chamber; the dividing plate is disposed between the blood collection chamber and the auxiliary membrane; and the vent hole communicates with the space on the side of the auxiliary membrane opposite to the blood collection chamber.

[0011] Preferably, the gas regulating device includes: a main gas supply pipe, a venturi tube, a first branch pipe, a second branch pipe, a first gas guide branch, a second gas guide branch, and a second one-way valve; the venturi tube is provided with an inlet end, a tail end, and a negative pressure zone; the main gas supply pipe is connected to the inlet end of the venturi tube; the first branch pipe is provided with a first end and a second end; the second one-way valve is connected between the negative pressure zone of the venturi tube and the first end of the first branch pipe; the first gas guide branch is connected between the second end of the first branch pipe and the gas buffer chamber; the second gas guide branch is provided with a first end and a second end, and the first end of the second gas guide branch is connected to the first gas guide branch; the second branch pipe is provided with a first end and a second end, and the first end of the second branch pipe is connected to the tail end of the venturi tube.

[0012] Preferably, the flow regulating component includes: a valve body, an air supply port, a first air outlet, a second air outlet, a connecting air port, a driving diaphragm, and a first piston; the valve body has a space inside for the first piston to move; the first piston is movably disposed within the valve body; the driving diaphragm is disposed within the valve body and connected to the first piston; the air supply port is disposed on the side wall of the valve body and communicates with the interior of the valve body; the first air outlet is disposed on the side wall of the valve body and communicates with the interior of the valve body, and the air supply port is connected to the second end of the second diversion branch pipe; the second air outlet is disposed on the side wall of the valve body and communicates with the interior of the valve body, and the first air outlet and the second air outlet are spaced apart along the moving direction of the first piston; the connecting air port is disposed at one end of the valve body near the driving diaphragm and communicates with the space on the side of the driving diaphragm opposite to the first piston, and the connecting air port is connected to the second end of the second air guide branch; one end of the second air outlet is connected to the first flow regulating pipe, and the other end is connected to a release device; one end of the first air outlet is connected to the second flow regulating pipe, and the other end forms a vent end.

[0013] Preferably, the release device includes: a diluent chamber, a second piston, a needle, a liquid bladder, a pressure relief valve, a third diaphragm, and a fourth diaphragm; A diluent chamber is disposed on one side of the collection chamber; a second piston is movably disposed within the diluent chamber, dividing the diluent chamber into a gas-containing space and a diluent-containing space, the gas-containing space being connected to a first flow regulating tube; a needle is disposed at the end of the second piston facing the blood collection chamber; a liquid bladder is disposed on the outer wall of the diluent chamber corresponding to the diluent-containing space and communicates with the diluent-containing space; a pressure relief valve is disposed on the outer wall of the diluent chamber corresponding to the gas-containing space and communicates with the gas-containing space; a third diaphragm is disposed between the diluent chamber and the blood collection chamber; a fourth diaphragm is disposed between the blood collection chamber and the sample outlet tube; the needle, the third diaphragm, and the fourth diaphragm are arranged sequentially along the moving direction of the second piston.

[0014] Preferably, one end of the blood collection chamber is connected to the blood supply vessel, and the other end forms the blood inlet end; one end of the fourth membrane is connected to the blood collection chamber through the sample outlet tube, and the other end forms the sample outlet end.

[0015] Preferably, the first piston has a first position that connects the air supply port to the first air outlet and closes the second air outlet, and a second position that connects the air supply port to the second air outlet and closes the first air outlet; the driving diaphragm is a center-flipping diaphragm.

[0016] Preferably, the auxiliary membrane forms an auxiliary air chamber on the side opposite to the blood collection chamber, the vent hole is connected to the auxiliary air chamber, and the dividing plate is provided with multiple through holes, which are distributed at intervals.

[0017] Preferably, the effective volume increase formed when the auxiliary membrane deforms downward is not less than the volume of diluent that enters the blood collection chamber before the fourth membrane is punctured.

[0018] Preferably, the effective compensation volume of the liquid bladder is not less than the volume of fluid discharged required for the second piston to complete the third diaphragm puncture action.

[0019] Preferably, the diluent chamber is provided with a backstop structure to restrict the reverse movement of the second piston.

[0020] Preferably, the third diaphragm and the fourth diaphragm are respectively provided with a central thinning zone, a U-shaped weakening line or a cross weakening line; the needle body is provided with an axial flow guide groove or a lateral flow guide groove.

[0021] The colloidal gold reagent kit for home detection of human Brucella IgM / IgG antibodies via finger-prick blood proposed in this invention has the following advantages: 1. This invention integrates blood collection, quantitative blood collection, diluent release, blood and diluent premixing, and sample dispensing into a single sample processing device. This reduces manual blood aspiration, manual addition of diluent, and manual sample transfer, simplifying the testing process and lowering the probability of errors caused by numerous steps during home use.

[0022] 2. The present invention forms a negative pressure blood collection path through a venturi tube, a first shunt branch, a first gas guide branch, a gas buffer chamber, and a hydrophobic and breathable membrane, so that blood can enter the blood collection chamber through the supply blood vessel; after the blood collection chamber is full of blood, the gas regulating device can automatically switch the airflow to the release device, realizing the continuous connection between negative pressure blood collection and positive pressure release of diluent, thereby reducing the number of times the user needs to intervene repeatedly during the detection process.

[0023] 3. The present invention forms a staged processing structure through the second piston, needle body, liquid bladder, third membrane, fourth membrane and auxiliary membrane, so that the diluent first enters the blood collection chamber to premix with the blood, and then the sample outlet passage is opened; thereby reducing the premature discharge of insufficiently diluted blood and improving the consistency of the mixture entering the sample outlet tube.

[0024] 4. The present invention forms a relatively closed sample processing path by means of a blood supply vessel, a blood collection chamber, a hydrophobic and breathable membrane, a third membrane, and a fourth membrane. This can reduce the chance of blood, diluent, and mixture coming into contact with the external environment, reduce the risk of sample contamination during collection, dilution, mixing, and discharge, and reduce the risk of cross-contamination caused by blood spillage. Attached Figure Description

[0025] Figure 1 This is a schematic front view of the overall structure of the present invention; Figure 2This is a partial schematic diagram of the overall structure of the present invention; Figure 3 This is a schematic diagram of the gas supply device of the present invention; Figure 4 This is a schematic diagram of the pressure tube assembly structure of the present invention; Figure 5 This is a schematic diagram of the lifting device structure of the present invention; Figure 6 This is a schematic diagram of the blood collection needle assembly structure of the present invention; Figure 7 This is a schematic diagram of the gas regulating device of the present invention; Figure 8 This is a schematic diagram of the current regulation component structure of the present invention; Figure 9 This is a schematic diagram of the collection chamber structure of the present invention; Figure 10 This is a schematic diagram of the release device of the present invention.

[0026] In the diagram: 1. Shell; 11. Finger tip receiving cavity; 12. Needle outlet; 13. Annular blood collection groove; 2. Gas supply device; 21. Gas tank; 22. Inlet pipe; 23. First one-way valve; 24. Flow limiting valve; 25. Pressure tube assembly; 251. Rectangular frame; 252. First control board; 253. Second control board; 254. Upper pressure plate; 255. Lower pressure plate; 256. First insertion hole; 257. Second insertion hole; 258. Insertion strip; 259. 260. First reset component; 260. Second reset component; 3. Air ring; 31. Air outlet pipe; 32. First diaphragm; 4. Lifting device; 41. Top plate; 42. Bottom plate; 43. Limiting slide bar; 44. Mounting half ring; 45. Rib plate; 46. Airbag; 47. Spring; 48. Exhaust pipe; 49. Second diaphragm; 5. Blood collection needle assembly; 51. Blood collection needle; 52. Needle seat; 53. Side hole; 54. Stop block; 55. Supply blood vessel; 56. Third one-way valve; 6. Gas regulating device; 61. Main gas supply pipe; 62. Venturi tube; 63. First branch pipe; 64. Second branch pipe; 65. First gas guide branch; 66. Second gas guide branch; 67. Second check valve; 68. First flow regulating pipe; 69. Second flow regulating pipe; 610. Flow regulating assembly; 6101. Valve body; 6102. Gas supply port; 6103. First gas outlet; 6104. Second gas outlet; 6105. Connecting gas port; 610 6. Driving membrane; 6107. First piston; 7. Collection chamber; 71. Blood collection chamber; 72. Gas buffer chamber; 73. Hydrophobic and breathable membrane; 74. Auxiliary membrane; 75. Dividing plate; 76. Auxiliary gas chamber; 77. Vent hole; 8. Release device; 81. Diluent chamber; 82. Second piston; 83. Needle body; 84. Liquid bladder; 85. Pressure relief valve; 86. Third membrane; 87. Fourth membrane; 9. Sample outlet tube; 10. Height adjustment device. Detailed Implementation

[0027] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0028] Please see Figures 1-10 This invention provides a technical solution for a colloidal gold reagent kit for home testing of human Brucella IgM / IgG antibodies via finger-prick blood. The detailed connection method is a well-known technology in the field. The working principle and process are mainly described below.

[0029] This embodiment provides a colloidal gold test kit for home detection of human Brucella IgM / IgG antibodies via finger prick blood. The kit includes a shell 1 and a gas supply device 2, an air ring 3, a lifting device 4, a height adjustment device 10, a blood collection needle assembly 5, a gas regulation device 6, a collection chamber 7, a release device 8, a blood supply tube 55, a sample outlet tube 9, and a colloidal gold test card disposed within the shell 1. The housing 1 has an internal installation space for accommodating and fixing the various components. The upper part of the housing 1 is provided with a fingertip receiving cavity 11 for the user to place and press the fingertip. The bottom of the fingertip receiving cavity 11 is provided with a needle outlet 12 and an annular blood collection groove 13, which surrounds the needle outlet 12.

[0030] An air ring 3 is disposed on the outer periphery of the fingertip receiving cavity 11, a lifting device 4 is disposed below the fingertip receiving cavity 11, and a blood collection needle assembly 5 is disposed on the top of the lifting device 4. The blood collection needle 51 in the blood collection needle assembly 5 is correspondingly disposed with the needle outlet 12 and can extend or retract through the needle outlet 12 under the drive of the lifting device 4.

[0031] The height adjustment device 10 is located below the lifting device 4. The height adjustment device 10 is used to support the lifting device 4 on the one hand, and to adjust the height of the lifting device 4 relative to the bottom of the fingertip receiving cavity 11 on the other hand, thereby adjusting the effective length of the blood collection needle 51 after it extends out of the needle hole 12 and the depth of the blood collection needle 51 inserted into the fingertip. The height adjustment device 10 can adopt a structure that can achieve height adjustment and support positioning effects. This embodiment does not further limit its internal structure.

[0032] The gas regulating device 6 is located on one side of the lifting device 4 and is connected to the lifting device 4, the collection chamber 7 and the release device 8 respectively. The collection chamber 7 is connected to the blood collection needle assembly 5 through the blood supply tube 55. The release device 8 is located on one side of the collection chamber 7 and the sample outlet tube 9 is located on the side of the collection chamber 7 facing away from the release device 8.

[0033] In this embodiment, the inlet pipe 22, supply pipe 55, sample outlet pipe 9, main supply pipe 61, first shunt branch pipe 63, second shunt branch pipe 64, first air guide branch 65, second air guide branch 66, first regulating pipe 68, second regulating pipe 69, exhaust pipe 48, and all connecting pipes are made of flexible tubing. The flexible tubing can be medical silicone tubing, thermoplastic elastomer tubing, or other flexible tubing suitable for disposable in vitro diagnostic devices. Each flexible tubing can be fixed by a slot, buckle, or limiting structure provided in the housing 1.

[0034] More specifically, the gas supply device 2 includes a gas tank 21, a pressure pipe assembly 25, an air inlet pipe 22, a first one-way valve 23, and a flow limiting valve 24. The gas tank 21 is disposed inside the housing 1 and is used to store positive pressure gas. One end of the air inlet pipe 22 is connected to the gas tank 21, and the other end is connected to the air ring 3. The first one-way valve 23 is disposed in the air inlet pipe 22 to restrict the unidirectional flow of gas from the gas tank 21 to the air ring 3 and to reduce the situation of gas flowing back into the gas tank 21. The flow limiting valve 24 is disposed in the air inlet pipe 22 to limit the gas flow rate output from the gas tank 21, so that the gas tank 21 can continue to supply flow-limiting gas to the lifting device 4 during the subsequent exhaust process. The pressure pipe assembly 25 is disposed in the air inlet pipe 22.

[0035] The pressure tube assembly 25 includes a rectangular frame 251, a first control plate 252, a second control plate 253, an upper pressure plate 254, a lower pressure plate 255, a first insertion hole 256, a second insertion hole 257, an insertion strip 258, a first reset component 259, and a second reset component 260. The rectangular frame 251 is fixedly installed inside the housing 1. The first control plate 252 and the second control plate 253 are parallel to each other and can both move along the vertical direction of the rectangular frame 251. The first control plate 252 and the second control plate 253 are located on the left and right sides of the rectangular frame 251, respectively. The upper pressure plate 254 is located on the side of the first control plate 252 facing the second control plate 253, and the lower pressure plate 255 is located on the side of the second control plate 253 facing the second control plate 253. On one side of the first control plate 252, the air intake pipe 22 passes through the space between the upper pressure plate 254 and the lower pressure plate 255. The first insertion hole 256 is located on the first control plate 252, and the second insertion hole 257 is located on the second control plate 253. Both the first insertion hole 256 and the second insertion hole 257 are located on the outside of the rectangular frame 251. The insertion strip 258 passes through the first insertion hole 256 and the second insertion hole 257 in sequence. The first reset member 259 is located between the rectangular frame 251 and the first control plate 252, and causes the first control plate 252 to have an upward tendency. The second reset member 260 is located between the rectangular frame 251 and the second control plate 253, and causes the second control plate 253 to have a downward tendency.

[0036] In the initial state, both the first reset member 259 and the second reset member 260 are under pressure. The insert 258 is inserted into the first insertion hole 256 and the second insertion hole 257 at the same time, so that the first control plate 252 and the second control plate 253 are kept close to each other. At this time, the upper pressure plate 254 and the lower pressure plate 255 jointly clamp the air intake pipe 22, causing the air intake pipe 22 to undergo elastic deformation and seal the internal flow channel.

[0037] When the user pulls out the insert 258, the first control plate 252 and the second control plate 253 are released from their constraints. The first control plate 252 moves upward under the action of the first reset member 259, and the second control plate 253 moves downward under the action of the second reset member 260, so that the upper pressure plate 254 and the lower pressure plate 255 move away from each other. The air inlet pipe 22 restores its flow cross section by its own elasticity, so that the air passage between the air tank 21 and the air ring 3 is connected.

[0038] The air ring 3 is disposed on the outer periphery of the fingertip receiving cavity 11 and surrounds the fingertip receiving cavity 11. The air ring 3 is a medium air bladder 46 structure that can undergo elastic deformation. One end of the air ring 3 is connected to the air inlet pipe 22, and the other end is connected to the lifting device 4 through the air outlet pipe 31. A first diaphragm 32 is disposed on the air outlet pipe 31.

[0039] Before the insert 258 is pulled out, the air inlet pipe 22 is clamped by the pressure pipe assembly 25, and the gas in the gas canister 21 cannot enter the air ring 3. After the insert 258 is pulled out, the air inlet pipe 22 is restored to conduction, and the gas in the gas canister 21 enters the air ring 3. At this time, if the user has not pressed the fingertip into the fingertip receiving cavity 11, the internal pressure of the air ring 3 is insufficient to rupture the first diaphragm 32.

[0040] When the user presses their fingertip into the fingertip receiving cavity 11, the air ring 3 is squeezed by the fingertip, and the internal pressure of the air ring 3 increases. When the pressure reaches the preset threshold, the first diaphragm 32 ruptures, making the air passage between the air ring 3 and the lifting device 4 open.

[0041] Therefore, the lifting device 4 only starts to operate after the fingertip is pressed in place, thereby reducing the possibility of the blood collection needle 51 extending prematurely before the fingertip is in place.

[0042] The lifting device 4 includes a top plate 41, a bottom plate 42, a limiting slide rod 43, a mounting half-ring 44, an airbag 46, a spring 47, and an exhaust pipe 48. The top plate 41 and the bottom plate 42 are spaced apart vertically, with the top plate 41 located above the bottom plate 42. The limiting slide rod 43 is positioned between the top plate 41 and the bottom plate 42, and is located on the axis of the top plate 41 and the bottom plate 42. The limiting slide rod 43 restricts the top plate 41 to move only in the axial direction and limits the maximum distance between the top plate 41 and the bottom plate 42. The mounting half-ring 44 is positioned between the top plate 41 and the bottom plate 42. Ring 44 is fixed to the middle position between top plate 41 and bottom plate 42 by rib plate 45. The arc-shaped inner wall of the mounting half-ring 44 is open towards the axis of the lifting device 4. Airbag 46 is disposed on the arc-shaped inner wall of the mounting half-ring 44. The air inlet end of airbag 46 is connected to air ring 3 through air outlet pipe 31, and the air outlet end of airbag 46 is connected to exhaust pipe 48. At least two springs 47 are provided. Multiple springs 47 are symmetrically arranged between top plate 41 and bottom plate 42 around the axis of lifting device 4. In the initial state, the springs 47 are arc-shaped, and the outer arc of the springs 47 faces the airbag. 46. ​​When the first diaphragm 32 ruptures, gas enters the airbag 46. The airbag 46 expands towards the center of the mounting semi-ring 44 and compresses the outer arc of the spring 47. The spring 47 deforms, causing the top plate 41 to move upward relative to the bottom plate 42. The exhaust pipe 48 is connected to the main gas supply pipe 61 in the gas regulating device 6 through the second diaphragm 49. Before the top plate 41 moves to its maximum distance, the second diaphragm 49 remains intact. When the top plate 41 moves to its maximum distance, the limiting slide rod 43 restricts the top plate 41 from moving further. At this time, the internal pressure of the airbag 46 continues to increase. As the pressure continues to rise, when it reaches a preset threshold, the second diaphragm 49 ruptures, connecting the exhaust pipe 48 to the main gas supply pipe 61. The exhaust capacity of the exhaust pipe 48 is greater than the gas supply capacity of the air inlet of the airbag 46. After the second diaphragm 49 ruptures, the airbag 46 first rapidly depressurizes, and the spring 47 gradually resets due to its own elasticity, causing the top plate 41 to move downwards, causing the blood collection needle 51 to automatically retract. After the second diaphragm 49 ruptures, the gas tank 21 continues to supply gas through the flow limiting valve 24. The gas continuously flows through the airbag 46, the exhaust pipe 48, and the main gas supply pipe 61, and enters the venturi tube 62.

[0043] The height adjustment device 10 is located below the base plate 42. The height adjustment device 10 is used to support the lifting device 4 and to adjust the height of the lifting device 4 relative to the bottom of the fingertip receiving cavity 11, thereby adjusting the effective length of the blood collection needle 51 after it extends out of the needle hole 12 and the depth of insertion into the fingertip.

[0044] The blood collection needle assembly 5 includes a blood collection needle 51, a needle holder 52, a blood supply tube 55, and a stop block 54. The needle holder 52 is disposed on the top plate 41, and the blood collection needle 51 is disposed on the needle holder 52 and moves up and down with the top plate 41. The blood collection needle 51 has a hollow structure, and a side hole 53 is provided near the needle tip of the blood collection needle 51. The side hole 53 communicates with the interior of the blood collection needle 51. The needle outlet 12 is disposed at the bottom of the fingertip receiving cavity 11. The blood collection needle 51 is correspondingly disposed with the needle outlet 12 and can pass through the needle outlet 12. The needle 51 is inserted into the fingertip receiving cavity 11 or retracted into the needle outlet 12. The annular blood collection groove 13 is located at the bottom of the fingertip receiving cavity 11 and surrounds the needle outlet 12. The stop block 54 is located in the needle outlet 12 and is positioned at the corresponding position of the side hole 53 after the blood collection needle 51 retracts. One end of the blood vessel 55 is connected to the needle seat 52 and communicates with the inside of the blood collection needle 51. The blood vessel 55 is also connected to the annular blood collection groove 13. The other end of the blood vessel 55 is connected to the blood collection chamber 71 in the collection chamber 7.

[0045] When the top plate 41 moves upward, the blood collection needle 51 extends into the fingertip receiving cavity 11 through the needle outlet 12 and pierces the fingertip placed in the fingertip receiving cavity 11. At this time, the side hole 53 disengages from the position corresponding to the stop block 54 and communicates with the outside. Blood can enter the blood collection needle 51 through the side hole 53 and enter the blood collection cavity 71 through the needle seat 52 and the blood supply vessel 55.

[0046] When the top plate 41 moves downward, the blood collection needle 51 retracts into the needle outlet 12, and the side hole 53 moves back to the position corresponding to the stop block 54, and is blocked or sealed by the stop block 54 to reduce the amount of outside air that continues to enter the blood supply vessel 55 through the side hole 53.

[0047] After the blood collection needle 51 retracts, the blood that continues to seep from the wound surface enters the annular blood collection groove 13 surrounding the needle outlet 12, and then enters the blood collection chamber 71 through the blood supply tube 55.

[0048] Gas regulating device 6 includes a main gas supply pipe 61, a venturi tube 62, a first branch pipe 63, a second branch pipe 64, a first guide pipe 65, a second guide pipe 66, a second one-way valve 67, a flow regulating assembly 610, a first flow regulating pipe 68, and a second flow regulating pipe 69. The venturi tube 62 is provided with an inlet end, an outlet end, and a negative pressure zone. One end of the main gas supply pipe 61 is connected to the exhaust pipe 48 through a second diaphragm 49, and the other end is connected to the inlet end of the venturi tube 62. One end of the second one-way valve 67 is connected to the venturi tube. The negative pressure zone of 62 is connected, and the other end is connected to the first end of the first branch pipe 63. The second end of the first branch pipe 63 is connected to the first gas guide branch 65. One end of the first gas guide branch 65 is connected to the first branch pipe 63, and the other end is connected to the gas buffer chamber 72 in the collection chamber 7. One end of the second gas guide branch 66 is connected to the first gas guide branch 65, and the other end is connected to the flow regulating component 610. One end of the second branch pipe 64 is connected to the tail end of the venturi tube 62, and the other end is connected to the flow regulating component 610.

[0049] The flow regulating assembly 610 includes a valve body 6101, an air supply port 6102, a first air outlet 6103, a second air outlet 6104, a connecting air port 6105, a driving diaphragm 6106, and a first piston 6107. The valve body 6101 has an internal space for the first piston 6107 to move. The first piston 6107 is movably disposed within the valve body 6101. The air supply port 6102 is disposed on the side wall of the valve body 6101 and connected to the second diversion branch pipe 64. The first air outlet 6103 is disposed on the connecting air port 6105. The valve body 6101 has a side wall and is connected to the second regulating pipe 69. The second air outlet 6104 is located on the side wall of the valve body 6101 and is connected to the first regulating pipe 68. The first air outlet 6103 and the second air outlet 6104 are spaced apart along the moving direction of the first piston 6107. The connecting air port 6105 is located at one end of the valve body 6101 near the driving diaphragm 6106. The connecting air port 6105 is connected to the second air guide branch 66. The driving diaphragm 6106 is located between the connecting air port 6105 and the first regulating pipe 68. Between pistons 6107, the first piston 6107 has a first position and a second position. In the first position, the air supply port 6102 is connected to the first air outlet 6103, and the second air outlet 6104 is closed. In the second position, the air supply port 6102 is connected to the second air outlet 6104, and the first air outlet 6103 is closed. One end of the second flow regulating pipe 69 is connected to the first air outlet 6103, and the other end forms a vent end. One end of the first flow regulating pipe 68 is connected to the second air outlet 6104, and the other end forms a vent end. The end is connected to the release device 8. The driving membrane 6106 adopts a center-flipping membrane. When the suction force on the driving membrane 6106 is lower than the preset threshold, the driving membrane 6106 maintains the initial state. When the suction force on the driving membrane 6106 reaches the preset threshold, the driving membrane 6106 flips and pushes the first piston 6107 from the first position to the second position. After the first piston 6107 moves to the second position, it is held in the second position by a slot, a latch, a barb or other positioning structure.

[0050] The collection chamber 7 includes a blood collection chamber 71, a gas buffer chamber 72, a hydrophobic and breathable membrane 73, an auxiliary membrane 74, a dividing plate 75, and a vent 77. Both the blood collection chamber 71 and the gas buffer chamber 72 are located within the collection chamber 7. The blood collection chamber 71 is located near the supply blood vessel 55, and the gas buffer chamber 72 is located near the first gas guide branch 65. The supply blood vessel 55 is connected to the blood collection chamber 71, and a third one-way valve 56 is provided between the supply blood vessel 55 and the blood collection chamber 71. The third one-way valve 56 allows blood to flow from the supply blood vessel 55 to the blood collection chamber 71 and restricts the backflow of blood from the blood collection chamber 71 back to the supply blood vessel 55. The first gas guide branch 65 is connected to the gas buffer chamber 72. The hydrophobic and breathable membrane 73 is located between the blood collection chamber 71 and the gas buffer chamber 72, allowing gas from the blood collection chamber 71 to flow back to the supply blood vessel 55. The body enters the gas buffer chamber 72, and the entry of blood into the gas buffer chamber 72 is restricted. The hydrophobic and breathable membrane 73 can be a hydrophobic microporous membrane suitable for gas-liquid isolation. The auxiliary membrane 74 is disposed below the blood collection chamber 71. The dividing plate 75 is disposed between the blood collection chamber 71 and the auxiliary membrane 74. The dividing plate 75 is provided with multiple spaced through holes. The dividing plate 75 is used to restrict the excessive deformation of the auxiliary membrane 74 toward the blood collection chamber 71, while allowing the pressure and liquid distribution in the blood collection chamber 71 to tend to be balanced. The side of the auxiliary membrane 74 facing away from the blood collection chamber 71 forms an auxiliary air chamber 76. The vent 77 is connected to the auxiliary air chamber 76. When the auxiliary membrane 74 deforms downward, the air in the auxiliary air chamber 76 is discharged through the vent 77. The vent 77 can be provided with a dustproof labyrinth, a hydrophobic and breathable structure or a one-way exhaust structure.

[0051] The release device 8 is located on one side of the collection chamber 7, and the sample outlet tube 9 is located on the side of the collection chamber 7 facing away from the release device 8. The release device 8, the blood collection chamber 71, and the sample outlet tube 9 are arranged sequentially in the same direction.

[0052] The release device 8 includes a diluent chamber 81, a second piston 82, a needle 83, a liquid bladder 84, a pressure relief valve 85, a third diaphragm 86, and a fourth diaphragm 87. The diluent chamber 81 has a cylindrical structure and is located on one side of the collection chamber 7. The end of the diluent chamber 81 facing the blood collection chamber 71 is connected to the blood collection chamber 71 via the third diaphragm 86. The second piston 82 is movably disposed within the diluent chamber 81, dividing the diluent chamber 81 into a gas-containing space and a diluent-containing space. The gas-containing space is located on the side of the second piston 82 facing away from the blood collection chamber 71, and the diluent-containing space is located on the side of the second piston 82 facing the blood collection chamber 71. A first flow regulating tube 68 is connected to the gas-containing space. The needle 83 is located at the end of the second piston 82 facing the blood collection chamber 71. The liquid bladder 84 is located in the diluent chamber 81 corresponding to the diluent-containing space. The outer wall of the liquid bladder 84 is connected to the diluent containing space. The liquid bladder 84 is capable of elastic deformation. A limit protection cover is provided on the outside of the liquid bladder 84 to limit the maximum deformation of the liquid bladder 84. The pressure relief valve 85 is located on the outer wall of the diluent cavity 81 corresponding to the gas containing space and is connected to the gas containing space. The pressure relief valve 85 is preferably a stroke-triggered pressure relief valve 85. When the second piston 82 moves to the maximum limit, the pressure relief valve 85 opens to allow the gas in the gas containing space to be discharged. The third diaphragm 86 is located between the diluent cavity 81 and the blood collection chamber 71. The fourth diaphragm 87 is located between the blood collection chamber 71 and the sample outlet tube 9. The needle body 83, the third diaphragm 86 and the fourth diaphragm 87 are arranged sequentially along the moving direction of the second piston 82. The third diaphragm 86 and the fourth diaphragm 87 are integrated flap-type diaphragms and are provided with a central thinning zone, a U-shaped weakening line or a cross weakening line to reduce the generation of free debris.

[0053] The needle body 83 adopts a short conical piercing needle, a cross-shaped piercing head, or a piercing protrusion with a flow guide groove. The needle body 83 can be provided with an axial flow guide groove or a lateral flow guide groove to avoid blocking the liquid flow channel after the needle body 83 pierces the membrane. The second piston 82 is provided with a sealing ring, which is located between the second piston 82 and the inner wall of the diluent chamber 81.

[0054] The diluent chamber 81 is equipped with a backstop structure, which is used to limit the second piston 82 from moving in the opposite direction after reaching its maximum limit.

[0055] An annular distribution groove is provided between the diluent chamber 81 and the blood collection chamber 71. The annular distribution groove is connected to multiple spaced outflow holes, so that the diluent can enter the blood collection chamber 71 from multiple positions. The blood collection chamber 71 can also be provided with guide ribs, arc-shaped guide grooves or staggered flow ribs.

[0056] One end of the sample tube 9 is connected to the blood collection chamber 71 via the fourth membrane 87, and the other end is connected to the sample pad of the colloidal gold test card. An air bubble trapping chamber is provided at the end of the sample tube 9 near the blood collection chamber 71 to reduce the entry of air bubbles into the subsequent testing site.

[0057] The colloidal gold test card can use the existing colloidal gold immunochromatographic detection structure. The colloidal gold test card includes a sample pad, a conjugate pad, a nitrocellulose membrane and an absorbent pad connected in sequence. The nitrocellulose membrane is equipped with a human Brucella IgM antibody detection line, a human Brucella IgG antibody detection line and a quality control line. After the mixed solution discharged from the sample tube 9 enters the sample pad, it migrates to the subsequent detection area by capillary action.

[0058] Working principle: When in use, the user first pulls out the plug 258. The first control board 252 and the second control board 253 move away from each other under the action of the first reset member 259 and the second reset member 260, respectively, so that the air inlet pipe 22 is restored to conduction. The positive pressure gas in the gas tank 21 enters the air ring 3 through the air inlet pipe 22. The user places their fingertip into the fingertip receiving cavity 11 and presses down on the air ring 3. After the air ring 3 is pressed, the internal pressure increases, causing the first diaphragm 32 to rupture. Gas enters the air bladder 46 in the lifting device 4. The air bladder 46 expands and squeezes the spring 47, causing the top plate 41 to move upward. The blood collection needle 51 moves upward with the top plate 41 and extends through the needle outlet 12 located at the bottom of the fingertip receiving cavity 11 to complete the fingertip puncture. When the top plate 41 moves to the maximum distance, the internal pressure of the airbag 46 increases further, causing the second diaphragm 49 to rupture. The gas in the airbag 46 enters the main gas supply pipe 61 through the exhaust pipe 48. Since the exhaust capacity of the exhaust pipe 48 is greater than the gas supply capacity of the airbag 46 inlet, the airbag 46 quickly loses pressure, the spring 47 resets, and the top plate 41 moves downward, causing the blood collection needle 51 to automatically retract into the needle outlet 12. After the blood collection needle 51 retracts, the side hole 53 moves to the position corresponding to the stop block 54 and is blocked or sealed by the stop block 54. The blood that continues to seep from the surface of the fingertip wound is collected by the annular blood collection groove 13 surrounding the needle outlet hole 12 and enters the blood collection chamber 71 through the blood supply tube 55. Gas tank 21 continues to supply flow-limiting gas to lifting device 4 through flow-limiting valve 24. The gas is continuously discharged through air bag 46, exhaust pipe 48, main gas supply pipe 61 and venturi tube 62. The negative pressure zone of venturi tube 62 forms a suction effect. The suction action is applied to the gas buffer chamber 72 through the second one-way valve 67, the first diversion branch pipe 63 and the first air guide branch 65. The air in the blood collection chamber 71 enters the gas buffer chamber 72 through the hydrophobic and breathable membrane 73 and is then drawn away, allowing blood to gradually enter the blood collection chamber 71. When the blood collection chamber 71 is not yet full of blood, the suction force on the driving membrane 6106 is insufficient to drive the driving membrane 6106 to flip. The first piston 6107 remains in the first position, and the gas from the tail end of the venturi tube 62 is discharged to the outside through the second branch pipe 64, the gas supply port 6102, the first gas outlet 6103 and the second regulating pipe 69. When the blood collection chamber 71 is full of blood, the blood covers the hydrophobic and breathable membrane 73. The suction effect in the first air guide branch 65 is concentrated on the driving membrane 6106 through the second air guide branch 66. When the suction effect on the driving membrane 6106 reaches the preset threshold, the driving membrane 6106 flips and pushes the first piston 6107 from the first position to the second position. At this time, the first air outlet 6103 is closed and the second air outlet 6104 is opened. Gas enters the gas-containing space in the release device 8 through the second gas outlet 6104 and the first flow regulating pipe 68, and pushes the second piston 82 toward the blood collection chamber 71; In the initial stage of the movement of the second piston 82, since the third diaphragm 86 has not yet opened, the liquid in the diluent container space is difficult to compress. At this time, some of the diluent enters the liquid bladder 84 or squeezes the liquid bladder 84, causing the liquid bladder 84 to undergo elastic deformation, providing the initial movement distance for the second piston 82. The second piston 82 continues to move, causing the needle 83 to pierce the third membrane 86, and the diluent container space connects with the blood collection chamber 71, and the diluent gradually enters the blood collection chamber 71. At this time, the fourth membrane 87 remains intact, the auxiliary membrane 74 deforms in the direction away from the blood collection chamber 71, the air in the auxiliary air chamber 76 is discharged through the vent 77, and the blood collection chamber 71 forms a temporary volume-increasing space, so that the diluent can enter the blood collection chamber 71 first and premix with the blood. When the second piston 82 continues to move to the maximum limit, the needle body 83 punctures the fourth membrane 87, making the blood collection chamber 71 connected to the sample outlet tube 9. The auxiliary membrane 74 gradually recovers and pushes the premixed liquid into the sample outlet tube 9. After the second piston 82 reaches its maximum limit, the pressure relief valve 85 opens, allowing the residual gas in the gas containing space to be discharged. The mixture enters the sample pad of the colloidal gold detection card through the sample outlet tube 9 and completes subsequent detection through the colloidal gold detection card.

[0059] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A colloidal gold reagent kit for home detection of human Brucella IgM / IgG antibodies via finger-prick blood, characterized in that... include: Collection chamber (7), release device (8), gas regulating device (6), supply tube (55) and sample outlet tube (9); the supply tube (55) is connected to the collection chamber (7), the sample outlet tube (9) is connected to the collection chamber (7), the release device (8) is connected to the collection chamber (7) and the gas regulating device (6) respectively, and the gas regulating device (6) is connected to the collection chamber (7); The collection chamber (7) includes: The blood collection chamber (71) is located inside the collection chamber (7) and connected to the blood supply vessel (55); A gas buffer chamber (72) is disposed within the collection chamber (7); A hydrophobic and breathable membrane (73) is disposed between the blood collection chamber (71) and the gas buffer chamber (72); An auxiliary membrane (74) is disposed below the blood collection chamber (71); A dividing plate (75) is disposed between the blood collection chamber (71) and the auxiliary membrane (74); The vent (77) is connected to the space on the side of the auxiliary membrane (74) facing away from the blood collection chamber (71); The gas regulating device (6) includes: The venturi tube (62) is equipped with an air inlet, a tail end, and a negative pressure zone; The main gas supply pipe (61) is connected to the air inlet end of the venturi tube (62); The first branch pipe (63) is provided with a first end and a second end; The second one-way valve (67) is connected between the negative pressure zone of the venturi tube (62) and the first end of the first branch pipe (63); The first gas guide branch (65) is connected between the second end of the first branch pipe (63) and the gas buffer chamber (72); The second air guide branch (66) is provided with a first end and a second end, and the first end of the second air guide branch (66) is connected to the first air guide branch (65); The second branch pipe (64) is provided with a first end and a second end, and the first end of the second branch pipe (64) is connected to the tail end of the venturi pipe (62).

2. The human Brucella IgM / IgG antibody finger-prick blood home detection colloidal gold reagent kit according to claim 1, characterized in that, The current regulation component (610) includes: The valve body (6101) has an internal space for the first piston (6107) to move; The first piston (6107) is movably disposed within the valve body (6101); A driving diaphragm (6106) is disposed inside the valve body (6101) and connected to the first piston (6107); An air supply port (6102) is provided on the side wall of the valve body (6101) and communicates with the interior of the valve body (6101); The first air outlet (6103) is located on the side wall of the valve body (6101) and communicates with the interior of the valve body (6101). The air supply port (6102) is connected to the second end of the second branch pipe (64). The second air outlet (6104) is disposed on the side wall of the valve body (6101) and communicates with the interior of the valve body (6101). The first air outlet (6103) and the second air outlet (6104) are spaced apart along the moving direction of the first piston (6107). A connecting air port (6105) is provided at one end of the valve body (6101) near the driving diaphragm (6106) and communicates with the space on the side of the driving diaphragm (6106) opposite to the first piston (6107). The connecting air port (6105) is connected to the second end of the second air guide branch (66). One end of the second air outlet (6104) is connected to the first flow regulating pipe (68), and the other end is connected to the release device (8). One end of the first air outlet (6103) is connected to the second flow regulating pipe (69), and the other end forms a venting end.

3. The human Brucella IgM / IgG antibody finger-prick blood home detection colloidal gold reagent kit according to claim 2, characterized in that, The release device (8) includes: A diluent chamber (81) is disposed on one side of the collection chamber (7); The second piston (82) is movably disposed in the diluent chamber (81) and divides the diluent chamber (81) into a gas containing space and a diluent containing space, wherein the gas containing space is connected to the first flow regulating pipe (68); The needle body (83) is disposed at one end of the second piston (82) facing the blood collection chamber (71); A liquid bladder (84) is disposed on the outer wall of the diluent cavity (81) corresponding to the diluent containing space and is in communication with the diluent containing space; A pressure relief valve (85) is disposed on the outer wall of the diluent chamber (81) corresponding to the gas containing space and is in communication with the gas containing space; A third membrane (86) is disposed between the diluent chamber (81) and the blood collection chamber (71); A fourth membrane (87) is disposed between the blood collection chamber (71) and the sample outlet tube (9); The needle body (83), the third diaphragm (86) and the fourth diaphragm (87) are arranged sequentially along the moving direction of the second piston (82).

4. The human Brucella IgM / IgG antibody finger-prick blood home detection colloidal gold reagent kit according to claim 3, characterized in that, One end of the blood collection chamber (71) is connected to the blood supply vessel (55), and the other end forms the blood inlet end. One end of the fourth membrane (87) is connected to the blood collection chamber (71) through the sample outlet tube (9), and the other end forms the sample outlet end.

5. The human Brucella IgM / IgG antibody finger-prick blood home detection colloidal gold reagent kit according to claim 4, characterized in that, The first piston (6107) has a first position that connects the air supply port (6102) with the first air outlet (6103) and closes the second air outlet (6104), and a second position that connects the air supply port (6102) with the second air outlet (6104) and closes the first air outlet (6103); the driving diaphragm (6106) is a center-flipping diaphragm.

6. The human Brucella IgM / IgG antibody finger-prick blood home detection colloidal gold reagent kit according to claim 5, characterized in that, The auxiliary membrane (74) forms an auxiliary air chamber (76) on the side opposite to the blood collection chamber (71). The vent hole (77) is connected to the auxiliary air chamber (76). The dividing plate (75) is provided with multiple through holes, which are distributed at intervals.

7. The human Brucella IgM / IgG antibody finger-prick blood home detection colloidal gold reagent kit according to claim 6, characterized in that, When the auxiliary membrane (74) deforms downward, the effective volume increase formed is not less than the volume of diluent that enters the blood collection chamber (71) before the fourth membrane (87) is punctured.

8. The human Brucella IgM / IgG antibody finger-prick blood home detection colloidal gold reagent kit according to claim 7, characterized in that, The effective compensation volume of the liquid bladder (84) is not less than the volume of fluid required for the second piston (82) to complete the puncture action of the third diaphragm (86).

9. The human Brucella IgM / IgG antibody finger-prick blood home detection colloidal gold reagent kit according to claim 8, characterized in that, The diluent chamber (81) is provided with a backstop structure to restrict the reverse movement of the second piston (82).

10. The human Brucella IgM / IgG antibody finger-prick blood home detection colloidal gold reagent kit according to claim 9, characterized in that, The third diaphragm (86) and the fourth diaphragm (87) are respectively provided with a central thinning zone, a U-shaped weakening line or a cross weakening line; the needle body (83) is provided with an axial flow guide groove or a side flow guide groove.

Images