Microfluid sample detection device and microfluid sample detection system

Abstract

The utility model provides a microfluid sample detection device and a microfluid sample detection system. The microfluid sample detection device comprises a fluid inlet, a microfluid channel, a fluid outlet, a reaction area, a liquid collecting area, a pump body, a valve body and a lock body, the valve body comprises a substrate, a double-sided colloid and a flexible diaphragm, a cavity is formed between the upper surface of the plastic substrate and the lower surface of the flexible diaphragm, the cavity is opened when the flexible diaphragm is loosened, and the cavity is closed when the flexible diaphragm is tensioned; the valve body comprises a first valve body and a second valve body, the second valve body is arranged on the downstream of the first valve body, and the working states of the first valve body and the second valve body are opposite; the lock body is arranged on the downstream of the second valve body. Moreover, the parallel scheme further comprises a conductive system composed of electrodes, the conductive system at least comprises two electrodes, and the electrode sensing ends are located at the two ends of the reaction area respectively. The microfluidic sample detection device is loaded in a detection device to form a microfluidic sample detection system.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, in particular to a microfluidic sample detection device and a microfluidic sample detection system. BACKGROUND

[0002] With the continuous development of intelligent technology, people's life, work and study increasingly use intelligent devices, and use intelligent technology to improve the quality of life and increase the efficiency of learning and work.

[0003] Microfluidic chip is a scientific technology that manipulates fluid in micron scale space as the main feature, has the ability to miniaturize the basic functions of biological and chemical laboratories to a few square centimeter chip, and is also called chip laboratory. At present, the mainstream form of microfluidic chip is formed by a network of microchannels, and the controllable fluid penetrates the entire system to realize various functions of conventional chemical or biological laboratories. The basic characteristics and greatest advantage of microfluidic chip are flexible combination and scale integration of various unit technologies on a small controllable platform. It is very suitable for the design of point-of-care testing (POCT) products. However, the materials commonly used to make microfluidic chips include glass and organic polymers such as polymethyl methacrylate (PMMA), polydimethylsiloxane (PDMS), polycarbonate (PC), and hydrogel. The processing and manufacturing environment, including air temperature, air humidity, and particle density in various media used in the process. Higher environmental requirements for chip manufacturing generally need to be achieved in a clean room. Clean room technology is closely related to the success of the microfluidic chip manufacturing process. Depending on the manufacturing method, the clean room standard needs to reach 10,000 or 1,000 or even 100. For example, the manufacturing technology of high polymer microfluidic chip mainly includes hot pressing method, molding method, injection molding method, laser ablation method, LIGA method, etc. However, the equipment used in the prior art is expensive and the steps are complex, not only strict requirements and high operating costs for the environmental quality during the process, but also low yield per batch, so the cost of the manufactured products is generally high. There is still a certain gap between the production capacity and cost requirements of point-of-care testing (POCT) products, which limits the popularization of microfluidic technology in the POCT industry.

[0004] At present, there is no effective solution to the above problems. SUMMARY

[0005] To solve the above problems, the utility model provides a kind of microfluidic sample detection device, including fluid inlet, microfluidic channel and fluid outlet, and reaction zone, liquid collection area, pump body, valve body, lock body;Valve body includes base plate, double-sided adhesive and flexible diaphragm, cavity is formed between the upper surface of plastic base plate and the lower surface of flexible diaphragm, cavity opens when flexible diaphragm relaxes, and cavity closes when flexible diaphragm is nervous;Valve body includes first valve body and second valve body, second valve body is located between pump body and microfluidic channel and is located downstream of first valve body, and the working state of first valve body and second valve body is opposite;Lock body is located downstream of second valve body.

[0006] Further, microfluidic channel includes first region and second region, and at least first region or second region is reaction zone, and pump body can drive microfluidic sample to enter first region and second region in sequence.

[0007] Or further, microfluidic channel includes first region, second region and third region, and at least first region or second region or third region is reaction zone, and pump body can drive microfluidic sample to enter first region, second region and third region in sequence.

[0008] In another embodiment, it further includes electrically conductive system composed of electrode, and electrically conductive system includes at least two electrodes, and electrode sensing end is located at both ends of reaction zone.

[0009] Further, electrically conductive system includes at least three electrodes, and electrode sensing end is distributed at both ends of first region and second region, and at least first region or second region is reaction zone, and pump body can drive microfluidic sample to enter first region and second region in sequence.

[0010] Further, electrically conductive system includes at least four electrodes, and electrode sensing end is distributed at both ends of first region, second region and third region, and at least first region or second region or third region is reaction zone, and pump body can drive microfluidic sample to enter first region, second region and third region in sequence.

[0011] In another embodiment, it further includes starting electrode, and starting electrode sensing end is located upstream of second valve body and is jointly formed in starting zone in microfluidic channel with first electrode sensing end downstream of second valve body.

[0012] Further, lock body is located between first electrode sensing end and second electrode sensing end, and first electrode sensing end and second electrode sensing end are close to second valve body and are located downstream of second valve body.

[0013] In another embodiment, the lock body is located in the microfluidic channel between the first electrode sensing end and the second electrode sensing end, which are close to and downstream of the second valve body. This invention also provides a microfluidic sample detection system, including a detection device and the aforementioned microfluidic sample detection apparatus. The microfluidic sample detection apparatus is mounted within the detection device, and the detection device is electrically / signally connected to the electrodes of the microfluidic detection apparatus.

[0014] Furthermore, the microfluidic sample detection device is electrically connected to the electrodes of the detection equipment via electrical contacts. The beneficial effects of this invention include: 1. The microfluidic sample detection device has a simple structure and is easy to manufacture, enabling its application in various in vitro diagnostic products using different methodologies. It can perform single-item detection, multi-item combined detection, and even combine electrochemical and photochemical detection methods into the same microfluidic sample detection device; 2. The liquid collection zone in the microfluidic sample detection device is located at the downstream end of the microfluidic channel, eliminating the problem of contaminating the detection equipment; 3. The valve and lock in the microfluidic sample detection device work together to complete sample quantification, resulting in superior accuracy and repeatability compared to traditional in vitro diagnostic electrochemical products when applied to them. Attached Figure Description

[0015] Figure 1-1 One embodiment of the microfluidic detection device of this utility model.

[0016] Figure 1-2 This is the second embodiment of the microfluidic detection device of the present invention.

[0017] Figure 1-3 This is the third embodiment of the microfluidic detection device of the present invention.

[0018] Figure 1-4 This is the fourth embodiment of the microfluidic detection device of the present invention.

[0019] Figure 2 This is the fifth embodiment of the microfluidic detection device of the present invention.

[0020] Figure 3-1 This is the sixth embodiment of the microfluidic detection device of the present invention.

[0021] Figure 3-2 This is the seventh embodiment of the microfluidic detection device of the present invention.

[0022] Figure 4-1 This is the eighth embodiment of the microfluidic detection device of the present invention.

[0023] Figure 4-2 This is the ninth embodiment of the microfluidic detection device of the present invention.

[0024] Figure 5The utility model discloses a microfluid detection device combination implementation mode.

[0025] Figure 6 The utility model discloses a microfluid detection equipment module schematic diagram no.

[0026] Figure 7 The utility model discloses a microfluid detection equipment module schematic diagram no.

[0027] Figure 8 The utility model discloses a microfluid detection equipment module schematic diagram no.

[0028] Figure 9 Example six the accuracy research result of the product of the present application.

[0029] Figure 10 Example six A the accuracy research result of the traditional product.

[0030] Figure 11 Example six B the accuracy research result of the traditional product. Specific embodiments

[0031] In order to make the personnel in the technical field better understand the present application scheme, the following will be combined with the drawings in the embodiment of the present application, and the technical scheme in the embodiment of the application is clearly and completely described, obviously, the described embodiment is only a part of the embodiment of the present application, not all the embodiment. Based on the embodiment in the present application, all other embodiments obtained by the ordinary skilled in the art without creative labor should belong to the scope of the present application.

[0032] Microfluidic detection device

[0033] As Figure 1-1As shown, one of the microfluidic detection devices for implementing the present application includes a fluid inlet 11, a fluid outlet 12, a microfluidic channel 13, a collection area 14, a reaction area 131, a pump body 41, a valve body, and a lock body 21. The fluid inlet 11 is used to add the microfluidic sample to be tested, the fluid outlet 12 is in communication with the environment, the microfluidic channel 13 is between the fluid inlet and the fluid outlet, the microfluidic sample to be tested enters from the fluid inlet and flows in the microfluidic channel, the volume of the microfluidic sample advancing in the microfluidic channel is the same as the volume of the gas discharged from the fluid outlet at the same time. The collection area 14 is downstream of the microfluidic channel and also downstream of the reaction area, used to receive the microfluidic sample after reaction, the fluid outlet is located at the outlet of the collection area and is in communication with the environment, which refers to the external environment of the microfluidic detection device of the present application, which can be the environment provided in the system of the present application, or can be the same as the environment outside the system of the present application. The fluid outlet allows gas or liquid to flow out, in most embodiments the fluid outlet is a gas outlet, only allowing gas to flow out, liquid cannot flow out; in a small part of the embodiment, the fluid outlet is a gas and liquid outlet, allowing both gas and liquid to flow out. The reaction area 131 is in the microfluidic channel between the fluid inlet and the fluid outlet, in other words, the reaction area partially coincides with the microfluidic channel. The microfluidic sample to be tested is designed to react with the fixed pre-prepared reagent in the reaction area during the flow in the microfluidic channel, at this time, the reaction area is the most downstream area.

[0034] The pump body 41 is located upstream of the reaction area, used to passively drive the microfluidic sample to flow in the microfluidic channel, in other words, by controlling the pressure applied to the pump body, a driving force can be provided for the flow of the microfluidic sample, which drives the microfluidic sample to be tested entering the microfluidic channel to continue to flow downstream. The pressure value applied to the pump body can be pre-set and associated with the advancing position of the microfluidic sample in the microfluidic channel after entering the microfluidic channel, that is, when the pressure value applied to the pump body is pre-set to a certain value, the microfluidic sample in the microfluidic channel is at a certain position, this design can be used to confirm the success of the microfluidic sample addition, and to determine that the microfluidic sample has entered the determined area.

[0035] The valve body includes two, one of the valve bodies 31 is arranged downstream of the fluid inlet, for controlling the on-off between the fluid inlet and the microfluidic channel, and is in the open state before the microfluidic sample enters the microfluidic channel; the second valve body 32 is arranged downstream of the first valve body and between the pump body and the microfluidic channel, for controlling the on-off between the pump body and the microfluidic channel, in other words, the second valve body controls the first pump body to determine whether to provide driving force for the microfluidic sample; the second valve body is also used to assist in determining the volume of the microfluidic sample finally participating in the reaction. The working states of the two valve bodies are opposite, that is, when the first valve body is open, the second valve body is closed, and when the second valve body is open, the first valve body is closed. When the second valve body is open and the first valve body is closed, the pump body and the microfluidic channel are communicated, and the pump body can passively drive the microfluidic sample to flow towards the fluid outlet.

[0036] In some embodiments, the valve body is composed of a plastic substrate and a flexible diaphragm, the plastic substrate includes an upper surface and a lower surface, a groove is formed on the upper surface by laser, etching or other methods, the flexible diaphragm includes an upper surface and a lower surface, the upper surface of the plastic substrate and the lower surface of the flexible diaphragm are bonded together by adhesive material, the upper surface of the plastic substrate and the lower surface of the flexible diaphragm are in contact and partially joined, a cavity is formed between the upper surface of the plastic substrate and the lower surface of the flexible diaphragm, the cavity is through when the flexible diaphragm is in a relaxed state, that is, the valve body is in an open state, and the cavity is not through when the flexible diaphragm is under pressure, that is, the valve body is in a closed state.

[0037] In other embodiments, the valve body is composed of a plastic substrate, a double-sided adhesive and a flexible diaphragm, the plastic substrate includes an upper surface and a lower surface, the double-sided adhesive includes a hollow, the flexible diaphragm includes an upper surface and a lower surface, the upper surface of the plastic substrate, the double-sided adhesive and the lower surface of the flexible diaphragm are pressed together to be bonded, a cavity is formed between the upper surface of the plastic substrate and the lower surface of the flexible diaphragm, the cavity is through when the flexible diaphragm is in a relaxed state, that is, the cavity is in an open state, and the valve body is also in an open state, the flexible diaphragm is in a tense state under pressure, so that the cavity is not through and is in a closed state, and the valve body is also in a closed state.

[0038] The lock body 21 is arranged downstream of the second valve body, and is used to define the volume of the microfluid sample to be tested. When the microfluid sample to be tested flows into the microfluid channel from the fluid inlet, and the front end of the microfluid sample to be tested contacts the lock body, the flow stops, and the volume of the microfluid sample to be tested in the microfluid channel between the fluid inlet and the lock body is the defined volume of the microfluid sample to be tested. In a further embodiment, the lock body and the second valve body cooperate to define the volume of the microfluid sample to be tested. When the microfluid sample to be tested flows into the microfluid channel from the fluid inlet, and the front end of the microfluid sample to be tested contacts the lock body, the flow stops, the first valve body is closed, the second valve body is opened, and the pump body drives the microfluid sample to be tested in the microfluid channel to flow downstream between the second valve body and the lock body, and the part of the microfluid sample to be tested flowing downstream is the defined volume of the microfluid sample to be tested.

[0039] As shown in Figure 1-2 , to implement the third microfluid detection device of the present application, on the basis of the first microfluid detection device or the second microfluid detection device or other subsequent microfluid detection devices, a conductive system composed of electrodes is further included. The conductive system includes two electrodes, electrode one 51 and electrode two 52, wherein electrode one further includes electrode contact one 511 and electrode sensing end one 512, electrode two further includes electrode contact two 521 and electrode sensing end two 522, and electrode sensing end one 512 and electrode sensing end two 522 are respectively located at the two ends of the reaction zone 131, i.e. electrode sensing end one is located at the starting end of the reaction zone, and electrode sensing end two is located at the terminal end of the reaction zone, and both electrode sensing end one and electrode sensing end two are located downstream of the second valve body and close to the second valve body, thereby ensuring that the reaction zone is downstream of the second valve body to ensure that the pump body realizes its driving function. The lock body can be located in the reaction zone or outside the reaction zone, but is located upstream of the terminal end of the reaction zone. As shown in Figure 1-2 (a), the lock body is in the reaction zone and downstream of the starting end of the reaction zone, that is, the lock body is in the microfluid channel between electrode sensing end one and electrode sensing end two, and electrode sensing end one and electrode sensing end two are close to the second valve body and located downstream of the second valve body. As shown in Figure 1-2 (b), the lock body is outside the reaction zone and close to electrode sensing end one, and is located in the microfluid channel upstream of electrode sensing end one, that is, the lock body is not between electrode sensing end one and electrode sensing end two, but is located downstream of the second valve body.

[0040] As shown in Figure 1-3 , to implement the third microfluid detection device of the present application, on the basis of the first microfluid detection device or the second microfluid detection device or other subsequent microfluid detection devices, a conductive system composed of electrodes is further included. The conductive system includes two electrodes, electrode one 51 and electrode two 52, wherein electrode one further includes electrode contact one 511 and electrode sensing end one 512, electrode two further includes electrode contact two 521 and electrode sensing end two 522, and electrode sensing end one 512 and electrode sensing end two 522 are respectively located at the two ends of the reaction zone 131, i.e. electrode sensing end one is located at the starting end of the reaction zone, and electrode sensing end two is located at the terminal end of the reaction zone, and both electrode sensing end one and electrode sensing end two are located downstream of the second valve body and close to the second valve body, thereby ensuring that the reaction zone is downstream of the second valve body to ensure that the pump body realizes its driving function. The lock body can be located in the reaction zone or outside the reaction zone, but is located upstream of the terminal end of the reaction zone. As shown in

[0041] As shown in Figure 1, the microfluidic detection device one of the present application comprises a conductive system, which comprises an electrode one 101, an electrode contact one 1011 and an electrode sensing end one 1012. The electrode one 101 is located in the microfluidic channel, and the electrode contact one 1011 is located outside the microfluidic channel. The electrode sensing end one 1012 is located in the microfluidic channel and is located at the start of the region one 1311. The electrode sensing end one 1012 is located downstream of the valve one 121. Figure 1-4 As shown in Figure 2, the microfluidic detection device two of the present application is based on the microfluidic detection device one, and further comprises a frame-shaped electrode 201, an electrode frame-shaped area 2011 and a frame-shaped contact 2012. Alternatively, the microfluidic detection device two of the present application is based on the microfluidic detection device one, and only comprises an electrode frame-shaped area 2011.

[0042] As shown in Figure 3, the microfluidic detection device three of the present application is based on the microfluidic detection device one or two, and further comprises an electrode three 301, which comprises an electrode contact three 3011 and an electrode sensing end three 3012. Alternatively, the microfluidic detection device three of the present application is based on the microfluidic detection device one or two, and only comprises an electrode sensing end three 3012. Figure 2 As shown in Figure 4, the microfluidic detection device five of the present application is based on the microfluidic detection device two, and the conductive system further comprises an electrode five 55, i.e. the electrode system comprises three electrodes. The electrode five comprises an electrode contact five 551 and an electrode sensing end five 552. The region one 1311 and the region two 1312 are formed in the microfluidic channel, and at this time, the region two is the most downstream region. Among them, the region one is the reaction region or the region two is the reaction region or both the region one and the region two are the reaction regions. When the pump body and the microfluidic channel are communicated through the valve body two, the pump body can drive the microfluidic sample to enter the region one and the region two in turn. The electrode sensing end one is located at the start of the region one, the electrode sensing end two is located at the end of the region one and is also the start of the region two, and the electrode sensing end five is located at the end of the region two. The electrode sensing end one, the electrode sensing end two and the electrode sensing end five are all located downstream of the valve body two, and the electrode sensing end one is close to the valve body two, so as to ensure that the region one and the region two are downstream of the valve body two, and at the same time ensure that the pump body realizes its driving function, while maximizing the duration of the driving force of the pump body. The lock body is in the region one and is located downstream of the start of the region one, that is, the lock body is located between the electrode sensing end one and the electrode sensing end two and is located downstream of the valve body two; or the lock body is outside the region one and is located upstream of the start of the region one, that is, the lock body is located outside the electrode sensing end one and the electrode sensing end two and is located downstream of the valve body two.

[0043] As shown in Figure 5, the microfluidic detection device six of the present application is based on the microfluidic detection device one, and further comprises an electrode six 601, which comprises an electrode contact six 6011 and an electrode sensing end six 6012. Alternatively, the microfluidic detection device six of the present application is based on the microfluidic detection device one, and only comprises an electrode sensing end six 6012. Figure 3-1As shown in Fig. 6, the microfluidic detection device of the present application is based on the microfluidic detection device of Fig. 5, and the conductive system further comprises electrode 6 56, i.e. the electrode system comprises four electrodes, electrode 6 comprises electrode contact 6 561 and electrode sensing end 6 562. Region 1 1311, region 2 1312 and region 3 1313 are formed in the microfluidic channel, and region 3 is the most downstream region. Among them, region 1 is a reaction zone, or region 2 is a reaction zone, or region 3 is a reaction zone, or any two of region 1, region 2 and region 3 are reaction zones, or all of region 1, region 2 and region 3 are reaction zones. When the pump body and the microfluidic channel are communicated through valve body 2, the pump body can drive the microfluidic sample to enter region 1, region 2 and region 3 in turn. Electrode sensing end 1 is located at the starting end of region 1, electrode sensing end 2 is located at the ending end of region 1 and is also the starting end of region 2, electrode sensing end 6 is located at the ending end of region 2 and is also the starting end of region 3, and electrode sensing end 5 is located at the ending end of region 3.

[0044] Further, electrode 7 is also included, electrode 7 comprises electrode contact 7 and electrode sensing end 7, and region 1, region 2, region 3 and region 4 are formed in the microfluidic channel, i.e. electrode sensing end 5 is located at the ending end of region 3 and is also located at the starting end of region 4, and electrode sensing end 7 is located at the ending end of region 4. At this time, region 4 is the most downstream region. Among them, region 1 is a reaction zone, or region 2 is a reaction zone, or region 3 is a reaction zone, or region 4 is a reaction zone, or any two / three of region 1, region 2, region 3 and region 4 are reaction zones, or all of region 1 to region 4 are reaction zones. When the pump body and the microfluidic channel are communicated through valve body 2, the pump body can drive the microfluidic sample to enter region 1, region 2, region 3 and region 4 in turn. As shown in Fig. 7, the microfluidic detection device of the present application is based on the microfluidic detection device of Fig. 5, and further comprises frame-shaped electrode 501, electrode frame-shaped area 5011 and frame-shaped contact 5012, or only electrode frame-shaped area 5011. The microfluidic detection device is formed by bonding the substrate and the film, the frame-shaped electrode is printed on the substrate, the electrode frame-shaped area is printed on the film and protrudes from the film, and when the substrate and the film are bonded together, the electrode frame-shaped area and the microfluidic channel in the substrate jointly form a region for gathering the pre-prepared reagent, and the two sides of the electrode frame-shaped area in the horizontal direction can be used as the electrode sensing end of the frame-shaped electrode. Figure 3-2

[0045] As shown in Fig. 8, the microfluidic detection device of the present application is based on the microfluidic detection device of Fig. 5, and further comprises frame-shaped electrode 501, electrode frame-shaped area 5011 and frame-shaped contact 5012, or only electrode frame-shaped area 5011. The microfluidic detection device is formed by bonding the substrate and the film, the frame-shaped electrode is printed on the substrate, the electrode frame-shaped area is printed on the film and protrudes from the film, and when the substrate and the film are bonded together, the electrode frame-shaped area and the microfluidic channel in the substrate jointly form a region for gathering the pre-prepared reagent, and the two sides of the electrode frame-shaped area in the horizontal direction can be used as the electrode sensing end of the frame-shaped electrode. Figure 4-1 ​As shown, this is an eighth microfluidic detection device for implementing the present invention. Based on any one of the first to seventh microfluidic detection devices or other subsequent microfluidic detection devices, it includes an electrode 51, an electrode contact 511, an electrode sensing end 512, an electrode 58, an electrode contact 581, and an electrode sensing end 582. The electrode sensing end 58 is located upstream of the second valve body, and the electrode sensing end 1 is located downstream of the electrode sensing end 58. The electrode sensing end 1, the electrode sensing end 58, and the microfluidic channel together form a starting area. The starting area is close to the microfluidic inlet. The electrode sensing end 8 is the starting end of the starting area, and the electrode sensing end 1 is the ending end of the starting area. In response to the start signal generated when the microfluidic sample flows into the starting area and contacts the first electrode sensing end, the first valve body closes and the second valve body opens.

[0046] like Figure 4-2 As shown, this is the ninth microfluidic detection device for implementing the present invention. Figure 4-1 Based on this, it also includes electrode two, electrode contact two, and electrode sensing end two. The lock body is located in the microfluidic channel between electrode sensing end one and electrode sensing end two, and is downstream of electrode sensing end one. Electrode sensing end one and electrode sensing end two are also located downstream of valve body two, close to valve body two. In another embodiment, refer to... Figure 1-2 (b), distinct from Figure 4-2 The lock body is not in the microfluidic channel between electrode sensing end one and electrode sensing end two, but in the microfluidic channel between electrode sensing end one and electrode sensing end eight. The lock body is located upstream of electrode sensing end one, while electrode sensing end one and electrode sensing end two are still close to valve body two and are also located downstream of valve body two.

[0047] Microfluidic detection devices one through eight can be arbitrarily copied and combined to form new microfluidic detection devices, with the combined microfluidic detection devices retaining only one fluid inlet. For example, microfluidic detection device one can be copied and combined to form a microfluidic detection device that includes one of the two microfluidic detection devices but retains only one fluid inlet, or microfluidic detection devices five and seven can both be copied and combined to form a microfluidic detection device that includes two units of microfluidic detection device five and two units of microfluidic detection device seven but retains only one fluid inlet.

[0048] like Figure 5 As shown, in order to implement the combined microfluidic detection device of the present invention, the fifth microfluidic detection device, the third microfluidic detection device based on the fifth microfluidic detection device, and the two seventh microfluidic detection devices are combined to form a microfluidic detection device that retains only one fluid inlet.

[0049] Microfluidic detection device

[0050] like Figure 6 ,Figure 7 , Figure 8 Figure 1 shows a schematic diagram of the configuration of the microfluidic detection device according to the present application, including the main control board, the display screen, the load position, the magnetic module, the temperature module, the optical module, the electrical module, the actuator, the battery, the power interface, and the timer. In the specific embodiment, the optical module and the electrical module at least include one of them; the magnetic module, the temperature module, and the display screen are optional designs, which can be included in the microfluidic detection device or not.

[0051] The power interface provides power for the operation of the detection device, and can charge the battery. The battery helps the detection device to work normally without power access, and realizes the portability of the detection device. After the detection device is turned on, the detection device is placed into the detection device. After the microfluidic sample detection device is accurately placed on the load position in the detection device, the load position will generate a loaded signal and transmit it to the main control board. The detection device and the detection device complete the signal connection, and the main control board commands the detection device to start running. In another embodiment, the main control board can be prompted to command the detection device to start running by clicking the button on the detection device.

[0052] The timer is pre-set to count down at least one reaction waiting time, which is to determine a fixed time period for the reaction of the microfluidic sample in the microfluidic channel. In another embodiment, the timer can also be set to count down the microfluidic sample loading waiting time, and the time when the detection device and the detection device complete the signal connection is the starting point of the loading waiting time. When the time in the timer is up, it is determined that the microfluidic sample to be tested has been successfully added. When the timer is used to determine that the sample has been successfully added, it is not necessary to use the above-mentioned optical detection unit to determine that the sample has been successfully added. In another embodiment, the timer can also be set to count down the time for the microfluidic sample to reach the fixed region (such as the reaction area). The countdown starts when the microfluidic sample starts to flow, and when the countdown ends, the microfluidic sample reaches the fixed region.

[0053] The actuator provides pressure to the pump body of the detection device, and provides pressure to the pump body after the microfluid sample to be detected is successfully added, compresses the pump body to drive the sample to flow to the downstream region of the microfluid channel in the detection device, where the downstream region refers to, for example, a processing region, a reaction region, a detection region, etc. In some embodiments, the pressure value applied by the actuator to the pump body can be pre-set and associated with the position of the microfluid sample in the microfluid channel after it enters the microfluid channel, that is, when the pressure value applied to the pump body is pre-set to a certain value, the microfluid sample in the microfluid channel is at a certain position, this design can be used to confirm that the microfluid sample is successfully added, and to determine that the microfluid sample has entered a certain region. For example, when the actuator applies a pressure value to a certain value, the microfluid sample flows to the reaction region, and in such embodiments, the countdown of the time for the microfluid sample to reach the fixed region in the above-mentioned timer can not be set. The actuator provides pressure to the valve body to close the valve body to close the microfluid channel, or releases the pressure to open the valve body to make the microfluid channel pass through. The optical module includes a light detection unit, which detects the reaction result of the microfluid sample to be detected, and the detection result is displayed on the display screen after being processed by the main control board. Or the optical module also includes a photoelectric conversion unit, and the detection result is displayed on the display screen after being processed by the main control board after being converted into an electrical signal by the photoelectric conversion unit.

[0054] In another aspect, the optical module is also used to determine whether the microfluid sample to be detected has been successfully added to the detection device, and the light detection unit determines that the microfluid sample to be detected has been successfully added by continuously detecting the light reflection state of the same position of the microfluid channel at different time points and converting it into an electrical signal by the photoelectric conversion unit.

[0055] The electrical module includes an electrical connector and an electrical detection unit, and the electrical connector provides a matched electrical contact for the electrode contact in the microfluid detection device. The microfluid detection device has as many electrical contacts as the microfluid detection device has electrical contacts. The main control board commands the electrical detection unit to output a continuous weak electrical signal (the time to stop outputting is after the microfluid sample to be detected is successfully added), which cannot be detected in the case of open circuit. When the detection device has been accurately placed on the load position of the detection equipment, the electrode contact on the detection device is matched with the electrical contact on the electrical connector, indicating that the detection device and the detection equipment have completed the electrical connection of the electrode. The electrical module determines that the microfluid sample to be detected has been successfully added by detecting the electrical signal between the electrodes. Alternatively, since the time taken by a microfluid sample of a certain volume to pass through a microfluid channel of a certain size is determined, the addition waiting time of the microfluid sample is pre-set in the timer, and the time when the detection device and the detection equipment complete the signal connection is taken as the starting point of the addition waiting time, and when the time in the timer is up, it is determined that the microfluid sample to be detected has been successfully added.

[0056] After the microfluid sample to be tested completes the reaction, the electrical detection unit of the electrical module detects the current generated by the electron transfer, and the current signal is transmitted to the main control board of the detection device through the electrode contact one and the electrode contact two through the corresponding electrical contact pins, and the detection result is displayed on the display screen after being processed by the main control board.

[0057] The magnetic module includes a magnet and a magnetic shielding body, the magnet is fixed near the downstream region of the microfluid channel in the detection device, and the magnet is isolated from the downstream region of the microfluid channel by the magnetic shielding body. When the microfluid sample to be tested enters the downstream region of the microfluid channel and the microfluid sample to be tested needs to be magnetically adsorbed and separated, the main control board commands the magnetic shielding body to move so that the magnetic field generated by the magnet acts on the microfluid sample to be tested.

[0058] The temperature module includes a heating unit, and the heating unit is fixed near the downstream region of the microfluid channel in the detection device. The main control board commands the heating unit to provide the required processing temperature for the microfluid sample to be tested, or to provide the required reaction temperature.

[0059] Microfluidic sample extraction system

[0060] The above microfluid sample detection device is loaded into a microfluid sample detection device to form a microfluid sample detection system. The detection device is electrically connected with the microfluid detection device. The detection device determines that the signal connection with the microfluid detection device is completed by receiving the load signal of the load position of the main control board, or the detection device determines that the electrode electrical connection with the microfluid detection device is completed by the signal formed by the electrode contact and the electrical contact pin of the electrical connector.

[0061] The microfluid detection device is prepared into a microfluid detection device for blood glucose detection. Red blood cells are used as the first target object, and magnetic particle combined anti-red blood cell antibodies are preloaded in region one. Glucose is used as the second target object, and a preparation containing glucose oxidase and an electron mediator is preloaded in region two. In this case, both region one and region two are reaction regions. The microfluid detection device for blood glucose detection is loaded into the detection device to form a microfluid sample detection system.

[0062] The above tests were repeated 10 times each using blood samples with glucose concentrations of 50 mg / dL, 100 mg / dL, 250 mg / dL, 400 mg / dL, and 550 mg / dL, respectively, and the results were obtained. A biochemical standard instrument was used as a control. The same blood samples were also tested 10 times each on existing conventional electrochemical blood glucose detection products: Brand A (high performance) and Brand B (mediocre performance), and the results are shown in Table 1. Table 1 shows that, compared with both Brand B and Brand A, the standard deviation and coefficient of variation are significantly reduced, indicating that the test results of this invention have lower data dispersion and lower repeatability among the glucose concentration measurements in the blood samples. The accuracy of the data in Table 1 was studied and plotted. Figure 9 , Figure 10 and Figure 11 As shown, the R of the present invention 2 Significantly outperformed traditional brand B products with average performance, and outperformed traditional brand R products with excellent performance. 2 This indicates that the glucose content measured in blood samples by the present invention is closer to the true value, and its accuracy is higher than that of existing products that perform well.

[0063] Table 1 Comparative Experiment Results of Example 6

[0064]

[0065] The above embodiments are only used to illustrate the technical solution of this utility model more clearly, and are therefore only examples, and cannot be used to limit the protection scope of this utility model.

[0066] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains; the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the invention; the terms "comprising" and "having," and any variations thereof, in the specification and claims of this invention, are intended to cover non-exclusive inclusion. In the description of this invention, technical terms such as "first," "second," "third," "fourth," etc., are used only to distinguish different objects and should not be construed as indicating or implying relative importance or implicitly specifying the number, specific order, or primary or secondary relationship of the indicated technical features. In the description of embodiments of this invention, "a plurality of" means two or more, unless otherwise explicitly defined.

[0067] Reference to "an embodiment", "one embodiment", or "an implementation" herein means that a particular feature, structure, or characteristic described in connection with the embodiment can be included in at least one embodiment of the application. The appearances of the phrase "in one embodiment" in various places in the specification are not necessarily all referring to the same embodiment, nor are they necessarily all directed to the same embodiment, or to one or more group of alternative embodiments.

[0068] The above embodiments are only used to illustrate the technical solutions of the present application, but not limit the present application; although the present application has been described in detail with reference to the foregoing embodiments, it should be understood by those skilled in the art that: the technical solutions recorded in the foregoing embodiments can still be modified, or part or all of the technical features can be replaced equivalently; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present application, and they should be covered in the scope of the claims and the specification of the present application. In particular, as long as there is no structural conflict, each technical feature mentioned in each embodiment can be combined in any way. The present application is not limited to the specific embodiments disclosed herein, but includes all technical solutions falling within the scope of the claims.

Claims

1. A microfluidic sample detection device, characterized in that, The system includes a fluid inlet, a microfluidic channel, and a fluid outlet, as well as a reaction zone, a liquid collection zone, a pump body, a valve body, and a lock body. The valve body comprises a substrate, a double-sided adhesive, and a flexible diaphragm. A cavity is formed between the upper surface of the plastic substrate and the lower surface of the flexible diaphragm. The cavity opens when the flexible diaphragm is relaxed and closes when the flexible diaphragm is tense. The valve body includes a first valve body and a second valve body. The second valve body is located between the pump body and the microfluidic channel and downstream of the first valve body. The first valve body and the second valve body operate in opposite states. The lock body is located downstream of the second valve body.

2. The microfluidic sample detection device according to claim 1, characterized in that, The microfluidic channel includes a first region and a second region, at least the first region or the second region is a reaction zone, and the pump can drive the microfluidic sample into the first region and the second region in sequence.

3. The microfluidic sample detection device according to claim 2, characterized in that, The microfluidic channel includes a first region, a second region, and a third region, at least the first region, the second region, or the third region is a reaction zone, and the pump can drive the microfluidic sample to enter the first region, the second region, and the third region sequentially.

4. The microfluidic sample detection device according to claim 1, characterized in that, It also includes a conductive system composed of electrodes, the conductive system comprising at least two electrodes, with the electrode sensing ends located at opposite ends of the reaction zone.

5. A microfluidic sample detection device according to claim 4, characterized in that, The conductive system includes at least three electrodes, with the electrode sensing ends distributed at both ends of the first region and the second region. At least the first region or the second region is a reaction zone, and the pump can drive the microfluidic sample to enter the first region and the second region sequentially.

6. The microfluidic sample detection device according to claim 5, characterized in that, The conductive system includes at least four electrodes, with the electrode sensing ends distributed at both ends of the first region, the second region, and the third region. At least the first region, the second region, or the third region is a reaction zone, and the pump can drive the microfluidic sample to enter the first region, the second region, and the third region in sequence.

7. A microfluidic sample detection device according to any one of claims 4-6, characterized in that, It also includes a start-up electrode, the sensing end of which is located upstream of the second valve body and together with the sensing end of the first electrode downstream of the second valve body, forms a start-up area in the microfluidic channel.

8. A microfluidic sample detection device according to any one of claims 4-6, characterized in that, The lock body is located in the microfluidic channel between the first electrode sensing end and the second electrode sensing end, and the first electrode sensing end and the second electrode sensing end are close to the second valve body and located downstream of the second valve body.

9. A microfluidic sample detection device according to claim 7, characterized in that, The lock body is located between the first electrode sensing end and the second electrode sensing end, and the first electrode sensing end and the second electrode sensing end are close to the second valve body and located downstream of the second valve body.

10. A microfluidic sample detection system, comprising a detection device and a microfluidic sample detection apparatus according to any one of claims 1-9, wherein the microfluidic sample detection apparatus is mounted in the detection device, and the detection device is electrically / signally connected to the electrodes of the microfluidic sample detection apparatus.

11. A microfluidic sample detection system according to claim 10, characterized in that, The microfluidic sample detection device is electrically connected to the electrodes of the detection equipment via electrical contacts.

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