Point-of-care testing cartridge, testing device and testing method

Abstract

A POCT cartridge, a POCT device, and a POCT method. The POCT cartridge comprises a cartridge body (100) and a rotary valve (200). The cartridge body (100) is provided with a sample loading cavity (101), a sample treatment cavity (102), a lysis liquid cavity (103), a magnetic bead liquid cavity (104), a cleaning liquid cavity (156), an eluent cavity (107), a rich solution cavity (108), a waste liquid cavity (109), a transfer cavity (110), a PCR cavity (1234), a power source cavity (115), and a ventilation cavity (116); a back surface of the cartridge body is further provided with a plurality of flow channels, and the power source cavity (115) is in communication with the transfer cavity (110). The rotary valve (200) is rotatably mounted on a front surface of the cartridge body (100), and the rotary valve (200) is provided with a valve liquid path (211), an exhaust gas path (221), and an exhaust structure (212). By rotating the rotary valve (200), the valve liquid path can be selectively brought into communication with the plurality of flow channels; in addition, under the action of a power source, various steps of sample addition, lysis, magnetic bead binding, cleaning, elution, mixing of a nucleic acid with a rich solution, and a PCR reaction can be completed.

Description

Instant test cartridge, test equipment, and test method

[0001] This application claims priority to the Chinese patent application filed with the China Patent Office on February 7, 2024, with application number 202410175021.0, the entire contents of which are incorporated by reference into this application. Technical Field

[0002] The present application relates to the field of molecular detection technology, for example, to a POCT detection cartridge, a POCT detection device and a POCT detection method. Background Art

[0003] In recent years, point-of-care testing (POCT) technology has rapidly developed and is playing an increasingly important role in medical testing. POCT testing, a subsector of the in vitro diagnostics (IVD) industry, involves rapid diagnosis performed immediately at the point of sampling, eliminating the complex laboratory processing of specimens and utilizing portable analytical instruments and supporting reagents to rapidly obtain test results.

[0004] However, related POCT test cartridges have numerous components, complex structures, and high costs. Not only do they require multiple on-off valves to transfer reagents or samples, but the flow path structure within the cartridge is also complex, making it difficult to manufacture, the testing process cumbersome, and inefficient. Furthermore, related POCT cartridges can typically only process simple, easily broken samples, and struggle with complex samples.

[0005] Summary of the Invention

[0006] The present application provides a POCT detection cartridge, a POCT detection device, and a POCT detection method to solve the problems in the related art of POCT detection cartridges having many parts, complex structure, high cost, difficult processing, cumbersome operation, and low efficiency.

[0007] The present invention provides a POCT test cartridge, comprising:

[0008] The cartridge body is provided with a sample loading chamber, a sample processing chamber, a lysis liquid chamber, a magnetic bead liquid chamber, a cleaning liquid chamber, an elution liquid chamber, a rich solution chamber, a waste liquid chamber, a transfer chamber, a PCR chamber, a power source chamber, and a ventilation chamber. The back of the cartridge body is also provided with multiple flow channels connected to the multiple chambers. The sample loading chamber is connected to the top of the sample processing chamber, the ventilation chamber is connected to the sample loading chamber, the power source chamber is configured to be connected to a power source, and the power source chamber is connected to the transfer chamber.

[0009] A rotary valve is rotatably mounted on the front of the cartridge body, and is provided with a valve liquid path, an exhaust gas path, and an exhaust structure. By rotating the rotary valve, the valve liquid path can be selectively connected to a plurality of the flow channels. At the same time, under the suction or blowing action of the power source, the sample in the sample loading chamber can enter the transfer chamber through the sample processing chamber, and then enter the sample processing chamber from the transfer chamber; or the lysate in the lysate chamber enters the transfer chamber, and then enters the sample processing chamber from the transfer chamber; or the sample after lysing in the sample processing chamber enters the transfer chamber, and then enters the sample processing chamber from the transfer chamber. The transfer chamber enters the magnetic bead liquid chamber; or the waste liquid in the magnetic bead liquid chamber enters the transfer chamber, and then enters the waste liquid chamber from the transfer chamber; or the cleaning liquid in the cleaning liquid chamber enters the transfer chamber, and then enters the magnetic bead liquid chamber from the transfer chamber; or the eluent in the elution liquid chamber enters the transfer chamber, and then enters the magnetic bead liquid chamber from the transfer chamber; or the rich solution in the rich solution chamber enters the transfer chamber, and then enters the magnetic bead liquid chamber from the transfer chamber; or the mixed liquid of the eluted nucleic acid and the rich solution in the magnetic bead liquid chamber enters the transfer chamber, and then enters the PCR chamber from the transfer chamber.

[0010] The present application also provides a POCT detection device, including the above-mentioned POCT detection cartridge, and also including a power source, a heating mechanism, a magnet mechanism, a magnetic rotation mechanism and a valve drive mechanism, wherein the power source is connected to the power source cavity, the heating mechanism is configured to heat the sample in the sample processing cavity, the magnet mechanism is configured to adsorb the magnetic beads in the POCT detection cartridge, the magnetic rotation mechanism is configured to drive the steel balls in the detection cartridge, and the valve drive mechanism is configured to drive the rotary valve to rotate.

[0011] The present application also provides a POCT detection method, using the above-mentioned POCT detection device, the POCT detection method comprising:

[0012] Sample loading: rotating the rotary valve, the power source inhales air to generate negative pressure, causing the sample to enter the transfer chamber from the sample loading chamber through the sample processing chamber; then the power source blows air to generate positive pressure, causing all the samples in the transfer chamber to enter the sample processing chamber;

[0013] Lysis: Turn the rotary valve, the power source inhales air to generate negative pressure, so that the lysate in the lysate chamber enters the transfer chamber; then turn the rotary valve, the power source blows air to generate positive pressure, so that the lysate in the transfer chamber enters the sample processing chamber, and the sample is treated by heating and / or grinding to lyse the sample and release nucleic acid substances;

[0014] Magnetic bead binding: the power source inhales air to generate negative pressure, causing the lysed sample to enter the transfer chamber from the sample processing chamber; then, the rotary valve is rotated, and the power source blows air to generate positive pressure, causing the lysed sample in the transfer chamber to enter the magnetic bead liquid chamber, and the magnetic beads are fully combined with the nucleic acid substance through magnetic bead stirring or air pump blowing; after binding, the magnetic beads are adsorbed by the magnet mechanism, and the power source inhales air to generate negative pressure, causing the waste liquid in the magnetic bead liquid chamber to enter the transfer chamber; then, the rotary valve is rotated, and the power source blows air to generate positive pressure, causing the waste liquid in the transfer chamber to enter the waste liquid chamber;

[0015] Cleaning: Turn the rotary valve, the power source inhales air to generate negative pressure, so that the cleaning liquid enters the transfer chamber from the cleaning liquid chamber; then turn the rotary valve, the power source blows air to generate positive pressure, so that the cleaning liquid in the transfer chamber enters the magnetic bead liquid chamber, and the nucleic acid material is cleaned by magnetic bead stirring or air pump blowing; after the cleaning is completed, the magnetic beads are adsorbed by the magnet mechanism, and the power source inhales air to generate negative pressure, so that the waste liquid in the magnetic bead liquid chamber enters the transfer chamber; then turn the rotary valve, the power source blows air to generate positive pressure, so that the waste liquid in the transfer chamber enters the waste liquid chamber;

[0016] Elution: Turn the rotary valve, the power source inhales air to generate negative pressure, and the eluent enters the transfer chamber from the eluent chamber; turn the rotary valve, the power source blows air to generate positive pressure, and the eluent in the transfer chamber enters the magnetic bead liquid chamber, and the nucleic acid substance is eluted by magnetic bead stirring or air pump blowing;

[0017] Mixing the nucleic acid and the rich solution: rotating the rotary valve, the power source sucks air to generate negative pressure, causing the rich solution to enter the transfer chamber from the rich solution chamber; rotating the rotary valve, the power source blows air to generate positive pressure, causing the rich solution in the transfer chamber to enter the magnetic bead liquid chamber, and mixing the nucleic acid substance and the rich solution;

[0018] PCR reaction: The magnetic beads are adsorbed by the magnetic mechanism, and the power source draws air to generate negative pressure, so that a mixture of eluted nucleic acid and rich solution of a set volume enters the transfer chamber from the magnetic bead liquid chamber; the rotary valve is turned, and the power source blows air to generate positive pressure, transferring the preset volume of rich solution product in the transfer chamber to the PCR chamber. After that, the POCT detection equipment runs the PCR reaction system and performs PCR detection. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] FIG1 is a schematic structural diagram of a POCT detection cartridge provided in an embodiment of the present application;

[0020] FIG2 is an exploded view of a POCT test cartridge provided in an embodiment of the present application;

[0021] FIG3 is a structural diagram of the front side of the card box body provided in an embodiment of the present application;

[0022] FIG4 is a schematic structural diagram of the flow channel on the back of the cartridge body provided in an embodiment of the present application;

[0023] FIG5 is an exploded view of a rotary valve provided in an embodiment of the present application from one perspective;

[0024] FIG6 is an exploded view of the rotary valve provided in an embodiment of the present application from another perspective;

[0025] FIG7 is a schematic diagram of the flow path connecting the sample processing chamber and the transfer chamber when the rotary valve is at 0 degrees according to an embodiment of the present application;

[0026] FIG8 is a schematic diagram of the flow path of the lysis liquid chamber and the transfer chamber when the rotary valve provided in an embodiment of the present application is at 180 degrees;

[0027] FIG9 is a schematic diagram of a flow path in which the transfer chamber and the magnetic bead liquid chamber are connected when the rotary valve provided in an embodiment of the present application is at 300 degrees;

[0028] FIG10 is a schematic diagram of the flow path in which the transfer chamber and the waste liquid chamber are connected when the rotary valve is at 150 degrees according to an embodiment of the present application;

[0029] FIG11 is a schematic diagram of the flow path of the first cleaning liquid chamber communicating with the transfer chamber when the rotary valve is at 210 degrees according to an embodiment of the present application;

[0030] FIG12 is a schematic diagram of the flow path of the second cleaning liquid chamber communicating with the transfer chamber when the rotary valve is at 240 degrees according to an embodiment of the present application;

[0031] FIG13 is a schematic diagram of the flow path in which the eluent chamber and the transfer chamber are connected when the rotary valve is at 270 degrees according to an embodiment of the present application;

[0032] FIG14 is a schematic diagram of the flow path of the rich solution chamber communicating with the transfer chamber when the rotary valve is at 330 degrees according to an embodiment of the present application;

[0033] Figure 15 is a schematic diagram of the flow path in which the transfer chamber is connected to the first PCR chamber, the second PCR chamber, the third PCR chamber and the fourth PCR chamber when the rotary valve provided in an embodiment of the present application is at 30 degrees, 60 degrees, 90 degrees and 120 degrees respectively.

[0034] In the picture:

[0035] 100, cartridge body; 101, sample loading chamber; 102, sample processing chamber; 103, lysis chamber; 104, magnetic bead chamber; 156, cleaning chamber; 105, first cleaning chamber; 106, second cleaning chamber; 107, elution chamber; 108, rich solution chamber; 109, waste chamber; 110, transfer chamber; 1234, PCR chamber; 111, first PCR chamber; 112, second PCR chamber; 113, third PCR chamber; 114, fourth PCR chamber; 115, power source chamber; 116, ventilation chamber; 117, filter chamber; 118, sample inlet; 119, protective cover; 121, bottom sealing film; 122, top sealing film; 123, side sealing film; 124, PCR sealing film; 125, first ventilation filter membrane; 126, first filter membrane sealing film; 127, power source filter element; 128, sample inlet filter element; 129, mounting slot; 130, buckle;

[0036] 200, rotary valve; 210, valve base; 211, valve fluid path; 212, exhaust structure; 220, valve soft rubber; 221, exhaust gas path; 230, valve sealing membrane; 240, second ventilation filter membrane; 250, second filter membrane sealing membrane;

[0037] 1. First flow channel; 2. Second flow channel; 3. Third flow channel; 4. Fourth flow channel; 5. Fifth flow channel; 6. Sixth flow channel; 7. Seventh flow channel; 8. Eighth flow channel; 9. Ninth flow channel; 10. Tenth flow channel; 11. Eleventh flow channel; 12. Twelfth flow channel; 13. Thirteenth flow channel; 14. Fourteenth flow channel; 15. Fifteenth flow channel; 16. Sixteenth flow channel; 17. Seventeenth flow channel; 18. Eighteenth flow channel; 19. Nineteenth flow channel; 20. Twentieth flow channel; 21. Twenty-first flow channel; 22. Twenty-second flow channel; 23. Twenty-third flow channel; 24. Twenty-fourth flow channel; 25. Twenty-fifth flow channel; 26. Twenty-sixth flow channel; 27. Twenty-seventh flow channel; 28. Twenty-eighth flow channel. DETAILED DESCRIPTION

[0038] The present application is described below with reference to the accompanying drawings and embodiments. The specific embodiments described herein are merely for the purpose of explaining the present application. It should also be noted that, for ease of description, the accompanying drawings only show portions relevant to the present application, not all structures.

[0039] In the description of this application, unless otherwise expressly specified or limited, the terms "connected," "connected," and "fixed" should be understood in a broad sense. For example, they can refer to fixed connections, detachable connections, or integration; mechanical connections or electrical connections; direct connections or indirect connections through an intermediate medium; and can refer to internal communication between two components or interaction between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on the specific circumstances.

[0040] As shown in Figures 1 to 6, this embodiment provides a POCT test cartridge, including a cartridge body 100 and a rotary valve 200. The cartridge body 100 is provided with a sample loading chamber 101, a sample processing chamber 102, a lysis liquid chamber 103, a magnetic bead liquid chamber 104, a cleaning liquid chamber 156, an elution liquid chamber 107, a rich solution chamber 108, a waste liquid chamber 109, a transfer chamber 110, a polymerase chain reaction (PCR) chamber 111, and a PCR amplification chamber 112. Reaction (PCR) chamber 1234, power source chamber 115 and ventilation chamber 116, wherein the sample loading chamber 101 is used to add the sample to be processed; the sample processing chamber 102 is loaded with the corresponding sample processing liquid, and the sample processing chamber 102 is connected to the bottom of the sample loading chamber 101, so that the sample in the sample loading chamber 101 enters the sample processing chamber 102 under the action of gravity; the lysis liquid chamber 103 is loaded with lysis liquid; the magnetic bead liquid chamber 104 is loaded with magnetic bead liquid; the cleaning liquid chamber 156 is loaded with cleaning liquid; The deliquescence chamber 107 is loaded with eluent; the rich solution chamber 108 is loaded with rich solution; the waste liquid chamber 109 is used to load waste liquid transferred from other chambers; the PCR chamber 1234 is loaded with freeze-dried pellets for PCR reactions (i.e., polymerase chain reaction); the power source chamber 115 is configured to connect to an external power source (such as an industrial syringe pump); the ventilation chamber 116 is connected to the sample loading chamber 101 to facilitate the circulation of gas inside and outside the cartridge; and the transfer chamber 110 is connected to the power source chamber 115 to facilitate the transfer of reagents or samples within the chambers. The back of the cartridge body 100 is provided with multiple flow channels for cooperating with the rotary valve 200 to achieve communication between the multiple chambers.

[0041] The rotary valve 200 is rotatably installed on the front of the card box body 100. The rotary valve 200 is provided with a valve liquid circuit 211, an exhaust gas circuit 221 and an exhaust structure 212. The valve liquid circuit 211 is configured to connect to the corresponding flow channel on the back of the card box body 100, and the exhaust gas circuit 221 is connected to the exhaust structure 212 to achieve the circulation of gas inside and outside the card box. By rotating the rotary valve 200, the valve liquid path 211 can be selectively connected to multiple flow channels. At the same time, under the suction or blowing action of the power source, the sample in the sample loading chamber 101 can enter the transfer chamber 110 through the sample processing chamber 102, and then enter the sample processing chamber 102 from the transfer chamber 110; or the lysate in the lysate chamber 103 can enter the transfer chamber 110, and then enter the sample processing chamber 102 from the transfer chamber 110; or the lysed sample in the sample processing chamber 102 can enter the transfer chamber 110, and then enter the magnetic bead liquid chamber 104 from the transfer chamber 110; or the waste liquid in the magnetic bead liquid chamber 104 can enter the transfer chamber 11 0, and then enters the waste liquid chamber 109 from the transfer chamber 110; or the cleaning liquid in the cleaning liquid chamber 156 enters the transfer chamber 110, and then enters the magnetic bead liquid chamber 104 from the transfer chamber 110; or the eluent in the elution liquid chamber 107 enters the transfer chamber 110, and then enters the magnetic bead liquid chamber 104 from the transfer chamber 110; or the rich solution in the rich solution chamber 108 enters the transfer chamber 110, and then enters the magnetic bead liquid chamber 104 from the transfer chamber 110; or the mixed liquid of the eluted nucleic acid and the rich solution in the magnetic bead liquid chamber 104 enters the transfer chamber 110, and then enters the PCR chamber 1234 from the transfer chamber 110, so as to realize the entire POCT detection process.

[0042] The POCT detection cartridge provided in this embodiment, by arranging the sample loading chamber 101 above the sample processing chamber 102, facilitates the sample to enter the sample processing chamber 102 under the dual action of gravity and power source; by arranging the transfer chamber 110, and the transfer chamber 110 is connected to the power source chamber 115, so that in multiple steps such as sample addition, lysis, magnetic bead binding, washing, elution, removal of waste liquid, mixing of nucleic acid and rich solution, PCR reaction, etc., the sample or reagent can first enter the transfer chamber 110, and then enter the corresponding chamber from the transfer chamber 110. This greatly simplifies the flow channel on the cartridge body 100 for connecting multiple chambers, and simplifies the flow path setting on the rotary valve 200. Only one valve liquid path 211 and one exhaust gas path 221 need to be set on the rotary valve 200 to achieve the conduction of the corresponding chambers in multiple POCT detection steps. The POCT test cartridge of the present application consists of a cartridge body 100 and a rotary valve 200, which has a simple structure, few parts, and is easy to assemble. Since the flow path on the cartridge body 100 is relatively simple, the cartridge is easier to process and has lower costs. By controlling the rotary valve 200 to rotate to different angles and cooperating with the suction or blowing action of the power source, the entire POCT test process can be completed, which is easy to operate and has high test efficiency.

[0043] Optionally, in this embodiment, the sample loading chamber 101 and the sample processing chamber 102 are arranged on the back of the card box body 100; the waste liquid chamber 109, the lysis liquid chamber 103, the cleaning liquid chamber 156, the elution liquid chamber 107 and the rich solution chamber 108 are arranged on the front of the card box body 100; the magnetic bead liquid chamber 104 and the transfer chamber 110 are arranged on the side of the card box body 100, and the openings are upward; the PCR chamber 1234 is arranged on the front of the card box body 100. Accordingly, in this embodiment, the back of the cartridge body 100 is covered with a bottom sealing film 121, which is configured to seal the sample loading chamber 101, sample processing chamber 102, and multiple flow channels on the back of the cartridge body 100. The front of the cartridge body 100 is covered with a top sealing film 122, which is configured to seal the waste liquid chamber 109, lysis liquid chamber 103, cleaning liquid chamber 156, elution liquid chamber 107, and rich solution chamber 108 on the front of the cartridge body 100. The side of the cartridge body 100 is covered with a side sealing film 123, which is configured to seal the magnetic bead liquid chamber 104 and transfer chamber 110 on the side of the cartridge body 100. The PCR chamber 1234 is sealed with a PCR sealing film 124. By providing the top sealing film 122, this embodiment avoids the need for a dedicated cover on the front of the cartridge, simplifying the cartridge structure. Furthermore, the sealing of the corresponding chambers and flow channels by the sealing film ensures the overall sealing reliability of the cartridge.

[0044] In addition, this embodiment also includes a sample inlet 118 and a protective cover 119 on the front of the cartridge body 100. The sample inlet 118 is connected to the sample loading chamber 101 and is configured to add a sample to the cartridge. The protective cover 119 is reversibly connected to the cartridge body 100 and is configured to close or open the sample inlet 118. A power source chamber 115 and a ventilation chamber 116 are also provided on the front of the cartridge body 100. The power source chamber 115 has a power source interface that communicates with the outside world, and the ventilation chamber 116 has a ventilation port that communicates with the outside world.

[0045] Optionally, the cartridge body 100 of this embodiment is provided with a mounting groove 129, into which the rotary valve 200 is rotatably mounted. The rotary valve 200 is axially limited by a buckle 130, resulting in simple assembly and reliable connection of the rotary valve 200. The rotary valve 200 of this embodiment includes a valve base 210 and a valve soft adhesive 220 disposed on the back of the valve base 210. An exhaust gas path 221 is disposed on the back of the valve soft adhesive 220. A valve fluid path 211 and an exhaust structure 212 are disposed on the front of the valve base 210. The valve fluid path 211 is covered with a valve sealing film 230. Optionally, the valve base 210 is made of polycarbonate (PC), polypropylene (PP), or the like, and the valve soft adhesive 220 is made of thermoplastic elastomer (TPE), or the like.

[0046] Since the samples to be processed may contain pathogens such as fungi, tuberculosis, and intracellular bacteria that are difficult to break through the wall, there may also be pathogens such as mycoplasma, chlamydia, and viruses that are relatively easy to break through the wall. In the related art, the structure of the POCT detection cartridge used to process samples that are difficult to break through the wall is usually more complicated and the cost is higher, while the low-cost POCT detection cartridge is usually unable to process complex samples that are difficult to break through the wall. In order to solve the above problems, the present embodiment can choose whether to load steel balls and grinding beads in the sample processing chamber 102 according to the difficulty of breaking the sample wall. If it is used to detect samples that are difficult to break through the wall, steel balls and grinding beads are loaded in the sample processing chamber 102 in advance before the cartridge is packaged so that the sample can be processed by grinding; if it is used to detect samples that are easy to break through the wall, in order to reduce costs, there is no need to load steel balls and grinding beads in the sample processing chamber 102. Optionally, in this embodiment, steel balls and grinding beads are pre-loaded in the sample processing chamber 102, and are configured to grind the sample in the sample processing chamber 102 to take into account the two different types of samples mentioned above, so that both difficult-to-break wall samples and easy-to-break wall samples can be processed, or difficult-to-break wall samples and easy-to-break wall samples can be processed at the same time, thereby increasing the number of detection items. In this embodiment, the steel balls can stir and collide with the grinding beads under the adsorption action of the magnetic rotating mechanism, and the grinding of the sample is achieved through the movement of the grinding beads. Of course, in other embodiments, the steel balls and grinding beads can also be stirred for grinding by repeatedly delivering gas to the sample processing chamber 102 through the pump body.

[0047] In some possible embodiments, a first ventilation filter membrane 125 is provided in the ventilation chamber 116, and a first filter membrane seal 126 is provided outside the first ventilation filter membrane 125; and / or a second ventilation filter membrane 240 is provided in the exhaust structure 212, and a second filter membrane seal 250 is provided outside the second ventilation filter membrane 240; and / or a power source filter element 127 is provided in the power source chamber 115; and / or the sample processing chamber 102 is also connected to the filter chamber 117, and a sample filter element 128 is provided in the filter chamber 117, and the sample filter element 128 is configured to filter the sample entering and exiting the sample processing chamber 102.

[0048] Optionally, a first ventilation filter 125 is provided in the ventilation chamber 116 of this embodiment, which is configured to filter the gas entering and exiting the cartridge; a first filter membrane seal 126 is provided outside the first ventilation filter 125 to prevent the first ventilation filter 125 from falling off. At the same time, a second ventilation filter 240 is provided in the exhaust structure 212, which is configured to filter the gas entering and exiting the exhaust structure 212; a second filter membrane seal 250 is provided outside the second ventilation filter 240 to prevent the second ventilation filter 240 from falling off. In addition, a power source filter element 127 is provided in the power source chamber 115, which is configured to filter the gas entering and exiting the POCT test cartridge. The above-mentioned arrangement effectively prevents external impurities from contaminating the sample or other solution in the cartridge, thereby avoiding affecting the test results. A filter chamber 117 is also provided on the back of the cartridge body 100. The filter chamber 117 is connected to the bottom of the sample processing chamber 102. An inlet filter element 128 is provided in the filter chamber 117, which can filter the lysate flowing into the sample processing chamber 102 and the sample solution flowing out of the sample processing chamber 102 to prevent the steel balls and grinding beads in the sample processing chamber 102 from flowing out.

[0049] Optionally, the bottom seal 121, top seal 122, side seal 123, PCR seal 124, and first filter seal 126 of this embodiment can all be connected to the cartridge body 100 via heat fusion or ultrasonic welding, resulting in simple packaging and reliable connections. Simultaneously, the valve seal 230 and second filter seal 250 can also be connected to the rotary valve 200 via heat fusion or ultrasonic welding, achieving simple packaging and reliable connections. Of course, in other embodiments, bonding, laser welding, or hot pressing can also be used to achieve the packaging of each seal.

[0050] Optionally, the cleaning liquid chamber 156 of this embodiment includes a first cleaning liquid chamber 105 and a second cleaning liquid chamber 106, each of which is used to load different cleaning liquids to fully clean the sample attached to the magnetic beads. The PCR chamber 1234 of this embodiment includes a first PCR chamber 111, a second PCR chamber 112, a third PCR chamber 113, and a fourth PCR chamber 114, each of which is used to perform different types of PCR tests. This configuration effectively increases the variety of POCT test items, allowing users to select one, two, three, or four PCR tests as needed.

[0051] In this embodiment, twenty-eight flow channels are provided on the card box body 100, namely: the first flow channel 1, the second flow channel 2, the third flow channel 3, the fourth flow channel 4, the fifth flow channel 5, the sixth flow channel 6, the seventh flow channel 7, the eighth flow channel 8, the ninth flow channel 9, the tenth flow channel 10, the eleventh flow channel 11, the twelfth flow channel 12, the thirteenth flow channel 13, the fourteenth flow channel 14, the fifteenth flow channel 15, the sixteenth flow channel 16, the seventeenth flow channel 17, the eighteenth flow channel 18, the nineteenth flow channel 19, the twentieth flow channel 20, the twenty-first flow channel 21, the twenty-second flow channel 22, the twenty-third flow channel 23, the twenty-fourth flow channel 24, the twenty-fifth flow channel 25, the twenty-sixth flow channel 26, the twenty-seventh flow channel 27 and the twenty-eighth flow channel 28. The above-mentioned multiple flow channels cooperate with the valve liquid path 211 to achieve communication between the corresponding chambers, thereby completing multiple steps in the POCT detection process, including sample addition, lysis, magnetic bead binding, washing, elution, waste liquid removal, mixing of nucleic acid and rich solution, and PCR reaction.

[0052] In this embodiment, the rotary valve 200 can achieve 360-degree rotation, and changes a state every 30 degrees of rotation, that is: when the rotary valve 200 is rotated to a first angle, the sample processing chamber 102 is connected to the transfer chamber 110; when the rotary valve 200 is at a second angle, the transfer chamber 110 is connected to the first PCR chamber 111; when the rotary valve 200 is rotated to a third angle, the transfer chamber 110 is connected to the second PCR chamber 112; when the rotary valve 200 is rotated to a fourth angle, the transfer chamber 110 is connected to the third PCR chamber 113; when the rotary valve 200 is rotated to a fifth angle, the fourth PCR chamber 114 of the transfer chamber 110 is connected; when the rotary valve 200 is rotated to a sixth angle, the transfer chamber 110 is connected to the fourth PCR chamber 114; When the rotary valve 200 is rotated to the first angle, the transfer chamber 110 is connected to the waste liquid chamber 109; when the rotary valve 200 is rotated to the seventh angle, the lysis liquid chamber 103 is connected to the transfer chamber 110; when the rotary valve 200 is rotated to the eighth angle, the first cleaning liquid chamber 105 is connected to the transfer chamber 110; when the rotary valve 200 is rotated to the ninth angle, the second cleaning liquid chamber 106 is connected to the transfer chamber 110; when the rotary valve 200 is rotated to the tenth angle, the elution liquid chamber 107 is connected to the transfer chamber 110; when the rotary valve 200 is rotated to the eleventh angle, the transfer chamber 110 is connected to the magnetic bead liquid chamber 104; when the rotary valve 200 is rotated to the twelfth angle, the rich solution chamber 108 is connected to the transfer chamber 110. Exemplarily, the first angle is 0 degrees, the second angle is 30 degrees, the third angle is 60 degrees, the fourth angle is 90 degrees, the fifth angle is 120 degrees, the sixth angle is 150 degrees, the seventh angle is 180 degrees, the eighth angle is 210 degrees, the ninth angle is 240 degrees, the tenth angle is 270 degrees, the eleventh angle is 300 degrees, and the twelfth angle is 330 degrees.

[0053] This embodiment also provides a point-of-care (POCT) testing device, comprising the aforementioned POCT test cartridge, a power source, a heating mechanism, a magnet mechanism, a magnetic rotation mechanism, and a valve drive mechanism. The power source is connected to the power source chamber 115 and can be, for example, an industrial syringe pump, which provides power for the flow of fluid within the cartridge by suction or blowing. The heating mechanism is configured to heat the liquid within the sample processing chamber 102 and the magnetic bead liquid chamber 104. The magnet mechanism is configured to attract the magnetic beads within the magnetic bead liquid chamber 104. The magnetic rotation mechanism is configured to drive the steel balls within the sample processing chamber 102. The valve drive mechanism can be a motor configured to rotate the rotary valve 200. The POCT testing device also includes a main control board, which controls the rotation of the rotary valve 200 and the operation of the power source to connect or disconnect corresponding chambers within the cartridge, thereby completing the entire POCT testing process. This embodiment has a simple structure, a small number of components, low cost, a wide range of test items, and is simple and convenient to operate.

[0054] This embodiment also provides a POCT detection method, using the POCT detection device as described above, the POCT detection method includes the following steps:

[0055] S1. Sample loading: Rotate the rotary valve 200 to 0 degrees. The power source draws air to generate negative pressure, causing the sample to flow from the sample loading chamber 101 through the sample processing chamber 102 into the transfer chamber 110. Then, the rotary valve 200 remains at 0 degrees. The power source blows air to generate positive pressure, causing all the sample in the transfer chamber 110 to enter the sample processing chamber 102.

[0056] S2, Lysis: The rotary valve is rotated from 200 to 180 degrees, and the power source draws air to generate negative pressure, causing the lysate in the lysate chamber 103 to enter the transfer chamber 110. The rotary valve is then rotated from 200 to 0 degrees, and the power source blows air to generate positive pressure, causing the lysate in the transfer chamber 110 to enter the sample processing chamber 102. The sample is then treated by at least one of heating and grinding to lyse the sample and release nucleic acid substances.

[0057] In this embodiment, for samples that are difficult to process, grinding beads and steel beads can be loaded in advance into the sample processing chamber 102 of the cartridge so as to process the sample by grinding in the lysis step.

[0058] S3, magnetic bead binding: the rotary valve 200 is kept at 0 degrees, the power source suction generates negative pressure, and the lysed sample enters the transfer chamber 110 from the sample processing chamber 102; then the rotary valve 200 is rotated to 300 degrees, the power source blows to generate positive pressure, and the lysed sample in the transfer chamber 110 enters the magnetic bead liquid chamber 104, and the magnetic beads are fully combined with the nucleic acid substance by magnetic bead stirring or air pump blowing; after the combination, the rotary valve 200 is kept at 300 degrees, the magnetic beads are adsorbed by the magnetic mechanism, and the power source suction generates negative pressure, so that the waste liquid in the magnetic bead liquid chamber 104 enters the transfer chamber 110, and magnetic beads with sample nucleic acid substances are obtained in the magnetic bead liquid chamber 104; then the rotary valve 200 is rotated to 150 degrees, and the power source blows to generate positive pressure, so that the waste liquid in the transfer chamber 110 enters the waste liquid chamber 109;

[0059] S41, cleaning 1: rotating the rotary valve 200 to 210 degrees, the power source suction generates negative pressure, so that the first cleaning liquid enters the transfer chamber 110 from the first cleaning liquid chamber 105; then rotating the rotary valve 200 to 300 degrees, the power source blows to generate positive pressure, so that the first cleaning liquid in the transfer chamber 110 enters the magnetic bead liquid chamber 104, and the nucleic acid material is cleaned by magnetic bead stirring or air pump blowing; after the cleaning is completed, the rotary valve 200 is maintained at 300 degrees, the magnetic beads are adsorbed by the magnet mechanism, and the power source suction generates negative pressure, so that the waste liquid in the magnetic bead liquid chamber 104 enters the transfer chamber 110; then rotating the rotary valve 200 to 150 degrees, the power source blows to generate positive pressure, so that the waste liquid in the transfer chamber 110 enters the waste liquid chamber 109;

[0060] S42, cleaning second: rotating the rotary valve 200 to 240 degrees, the power source suction generates negative pressure, so that the second cleaning liquid enters the transfer chamber 110 from the second cleaning liquid chamber 106; then rotating the rotary valve 200 to 300 degrees, the power source blows to generate positive pressure, so that the second cleaning liquid in the transfer chamber 110 enters the magnetic bead liquid chamber 104, and the nucleic acid material is cleaned by magnetic bead stirring or air pump blowing; after the cleaning is completed, the rotary valve 200 is maintained at 300 degrees, the magnetic beads are adsorbed by the magnet mechanism, and the power source suction generates negative pressure, so that the waste liquid in the magnetic bead liquid chamber 104 enters the transfer chamber 110; then rotating the rotary valve 200 to 150 degrees, the power source blows to generate positive pressure, so that the waste liquid in the transfer chamber 110 enters the waste liquid chamber 109;

[0061] In this embodiment, by washing twice with different washing solutions, the sample nucleic acid material can be fully washed to obtain a more purified sample nucleic acid material.

[0062] S5, elution: Turn the rotary valve 200 to 270 degrees, the power source inhales air to generate negative pressure, and the eluent enters the transfer chamber 110 from the eluent chamber 107; turn the rotary valve 200 to 300 degrees, and the power source blows air to generate positive pressure, and the eluent in the transfer chamber 110 enters the magnetic bead liquid chamber 104, and the nucleic acid material is eluted by magnetic bead stirring or air pump blowing;

[0063] S6. Mixing the nucleic acid and the rich solution: After elution is completed, the rotary valve is rotated 200 to 330 degrees, and the power source sucks air to generate negative pressure, so that the rich solution enters the transfer chamber 110 from the rich solution chamber 108; the rotary valve is rotated 200 to 300 degrees, and the power source blows air to generate positive pressure, so that the rich solution in the transfer chamber 110 enters the magnetic bead liquid chamber 104, and the nucleic acid substance and the rich solution are mixed; illustratively, the mixing can be performed by alternately sucking and inflating air with an air pump, or by stirring the magnetic beads.

[0064] S7, PCR reaction: The rotary valve 200 is maintained at 300 degrees, the magnetic beads are adsorbed by the magnet mechanism, and the power source draws air to generate negative pressure, so that the mixture of eluted nucleic acid and rich solution of the set volume enters the transfer chamber 110 from the magnetic bead liquid chamber 104; the rotary valve 200 is rotated to the angle corresponding to the corresponding PCR chamber, and the power source blows air to generate positive pressure, transferring the preset volume of rich solution product in the transfer chamber 110 to the corresponding PCR chamber. The POCT detection equipment runs the PCR reaction system and performs PCR detection.

[0065] In some embodiments, the set volume of the mixed solution of eluted nucleic acid and rich solution and the preset volume of the rich solution product can be set according to actual conditions.

[0066] In some embodiments, the PCR reaction of this embodiment includes at least one of the following reactions:

[0067] Reaction 1: The rotary valve is rotated 200 to 30 degrees, and the power source blows air to generate positive pressure, transferring the first preset volume of the enriched solution in the transfer chamber 110 to the first PCR chamber 111. The POCT testing device runs the first PCR reaction system and performs PCR testing;

[0068] Reaction 2: The rotary valve is rotated from 200 to 60 degrees, and the power source blows air to generate positive pressure, transferring the second preset volume of the enriched solution in the transfer chamber 110 to the second PCR chamber 112. The POCT testing device runs the second PCR reaction system and performs PCR testing;

[0069] Reaction 3: Rotate the rotary valve 200 to 90 degrees, and the power source blows air to generate positive pressure, transferring the third preset volume of the enriched solution in the transfer chamber 110 to the third PCR chamber 113. The POCT testing device runs the third PCR reaction system and performs PCR testing.

[0070] Reaction 4: Rotate the rotary valve 200 to 120 degrees, and the power source blows air to generate positive pressure, transferring the fourth preset volume of the enriched solution in the transfer chamber 110 to the fourth PCR chamber 114. The POCT testing device runs the fourth PCR reaction system and performs PCR testing.

[0071] This setting effectively increases the types of detection items. During use, users can choose to perform one, two, three or four PCR detection systems according to their needs.

[0072] In some embodiments, the preset volumes of the enriched solution transferred to different PCR chambers, i.e., the first preset volume, the second preset volume, the third preset volume, or the fourth preset volume, can be set according to actual conditions. For example, the preset volumes of the enriched solution in different PCR chambers can be different or the same.

[0073] The POCT testing device and method provided in this embodiment connect or block different flow paths simply by controlling the rotation of a rotary valve to different angles. Simultaneously, under the action of a power source, multiple testing steps can be completed, including sample addition, lysis, magnetic bead binding, washing, elution, waste liquid removal, mixing of nucleic acids with a rich solution, and PCR reaction. This testing process is simple and convenient, significantly reducing testing time compared to related technologies.

[0074] The following embodiment will describe the flow path of the POCT test cartridge when the rotary valve 200 is in each state with reference to FIG. 7 to FIG. 15 :

[0075] As shown in Figure 7, when the rotary valve 200 is rotated to 0 degrees, the POCT test cartridge is in the initial position, and the operator loads the sample into the sample loading chamber 101 through the sample inlet 118; at this time, the valve liquid path 211 connects the first flow channel 1 and the sixteenth flow channel 16; the power source inhales air, and the gas in the transfer chamber 110 enters the power source chamber 115 through the twenty-fifth flow channel 25, and the sample in the sample loading chamber 101 enters the transfer chamber 110 through the twenty-seventh flow channel 27, the sample processing chamber 102, the twenty-eighth flow channel 28, the filter chamber 117, the sixteenth flow channel 16, the valve liquid path 211, and the first flow channel 1 under the action of negative pressure; at the same time, the gas in the ventilation chamber 116 enters the sample loading chamber 101 through the twenty-sixth flow channel 26. Afterwards, the rotary valve 200 is maintained at 0 degrees, the power source blows air, and the gas in the power source chamber 115 enters the transfer chamber 110 through the twenty-fifth flow channel 25. The sample in the transfer chamber 110 enters the sample processing chamber 102 through the first flow channel 1, the valve liquid path 211, the sixteenth flow channel 16, the filter chamber 117, and the twenty-eighth flow channel 28; at the same time, the gas in the sample processing chamber 102 enters the ventilation chamber 116 through the twenty-seventh flow channel 27, the sample loading chamber 101, and the twenty-sixth flow channel 26.

[0076] As shown in Figure 8, when the rotary valve 200 rotates to 180 degrees, the valve liquid path 211 connects the first flow channel 1 and the fifth flow channel 5, and the exhaust gas path 221 connects the fourth flow channel 4; the power source inhales air, and the gas in the transfer chamber 110 enters the power source chamber 115 through the twenty-fifth flow channel 25, and the lysis liquid in the lysis liquid chamber 103 enters the transfer chamber 110 through the fifth flow channel 5, the valve liquid path 211, and the first flow channel 1 in sequence under the action of negative pressure; at the same time, the gas in the exhaust structure 212 enters the lysis liquid chamber 103 through the exhaust gas path 221 and the fourth flow channel 4. Continuing as shown in FIG7 , the rotary valve 200 is rotated to 0 degrees, the power source blows air, and the gas in the power source chamber 115 enters the transfer chamber 110 through the twenty-fifth flow channel 25. Under the action of positive pressure, the lysate in the transfer chamber 110 enters the sample processing chamber 102 through the first flow channel 1, the valve liquid path 211, the sixteenth flow channel 16, the filter chamber 117, and the twenty-eighth flow channel 28. At the same time, the gas in the sample processing chamber 102 enters the ventilation chamber 116 through the twenty-seventh flow channel 27, the sample loading chamber 101, and the twenty-sixth flow channel 26.

[0077] Continuing with reference to FIG7 , the rotary valve 200 is maintained at 0 degrees, the power source inhales air, and the gas in the transfer chamber 110 enters the power source chamber 115 through the twenty-fifth flow channel 25. The sample after lysis in the sample processing chamber 102 enters the transfer chamber 110 through the twenty-eighth flow channel 28, the filter chamber 117, the sixteenth flow channel 16, the valve liquid path 211, and the first flow channel 1 under the action of negative pressure. At the same time, the gas in the ventilation chamber 116 enters the sample processing chamber 102 through the twenty-sixth flow channel 26, the sample loading chamber 101, and the twenty-seventh flow channel 27. As shown in Figure 9, when the rotary valve is rotated 200 to 300 degrees, the valve liquid path 211 connects the first flow channel 1 and the thirteenth flow channel 13, and the exhaust gas path 221 connects the twelfth flow channel 12; the power source blows air, and the gas in the power source chamber 115 enters the transfer chamber 110 through the twenty-fifth flow channel 25, and the lysed sample in the transfer chamber 110 enters the magnetic bead liquid chamber 104 through the first flow channel 1, the valve liquid path 211, and the thirteenth flow channel 13 under the action of positive pressure; at the same time, the gas in the magnetic bead liquid chamber 104 enters the exhaust structure 212 through the twelfth flow channel 12 and the exhaust gas path 221.

[0078] Continuing to refer to Figure 9, turn the rotary valve 200 and keep it at 300 degrees, the power source inhales air, and the gas in the transfer chamber 110 enters the power source chamber 115 through the twenty-fifth flow channel 25, and the waste liquid in the magnetic bead liquid chamber 104 enters the transfer chamber 110 through the thirteenth flow channel 13, the valve liquid path 211, and the first flow channel 1. At the same time, the gas in the exhaust structure 212 enters the magnetic bead liquid chamber 104 through the exhaust gas path 221 and the twelfth flow channel 12. As shown in Figure 10, when the rotary valve is rotated from 200 to 150 degrees, the valve liquid path 211 connects the first flow channel 1 and the third flow channel 3, and the exhaust gas path 221 connects the second flow channel 2; the power source blows air, and the gas in the power source chamber 115 enters the transfer chamber 110 through the twenty-fifth flow channel 25, and the waste liquid in the transfer chamber 110 enters the waste liquid chamber 109 through the first flow channel 1, the valve liquid path 211, and the third flow channel 3 under the action of positive pressure; at the same time, the gas in the waste liquid chamber 109 enters the exhaust structure 212 through the second flow channel 2 and the exhaust gas path 221.

[0079] As shown in Figure 11, when the rotary valve is rotated 200 to 210 degrees, the valve fluid path 211 connects the first flow channel 1 and the seventh flow channel 7, and the exhaust gas path 221 connects the sixth flow channel 6. The power source draws air, and the gas in the transfer chamber 110 enters the power source chamber 115 via the twenty-fifth flow channel 25. The first cleaning liquid in the first cleaning liquid chamber 105 enters the transfer chamber 110 via the seventh flow channel 7, the valve fluid path 211, and the first flow channel 1. Simultaneously, the gas in the exhaust structure 212 enters the first cleaning liquid chamber 105 via the exhaust gas path 221 and the sixth flow channel 6. Continuing with Figure 9, the rotary valve is then rotated 200 to 300 degrees, and the power source blows air, allowing the first cleaning liquid in the transfer chamber 110 to enter the magnetic bead liquid chamber 104 via the first flow channel 1, the valve fluid path 211, and the thirteenth flow channel 13. Then, referring to Figures 9 and 10, the waste liquid after cleaning is transferred to the waste liquid chamber 109.

[0080] As shown in Figure 12, when the rotary valve is rotated 200 to 240 degrees, the valve fluid path 211 connects the first flow channel 1 and the ninth flow channel 9, and the exhaust gas path 221 connects the eighth flow channel 8. The power source draws air, and the gas in the transfer chamber 110 enters the power source chamber 115 via the twenty-fifth flow channel 25. The second cleaning liquid in the second cleaning liquid chamber 106 enters the transfer chamber 110 via the ninth flow channel 9, the valve fluid path 211, and the first flow channel 1. Simultaneously, the gas in the exhaust structure 212 enters the second cleaning liquid chamber 106 via the exhaust gas path 221 and the eighth flow channel 8. Continuing with Figure 9, the rotary valve is then rotated 200 to 300 degrees, and the power source blows air, allowing the second cleaning liquid in the transfer chamber 110 to enter the magnetic bead liquid chamber 104 via the first flow channel 1, the valve fluid path 211, and the thirteenth flow channel 13. Then, referring to Figures 9 and 10, the waste liquid after cleaning is transferred to the waste liquid chamber 109.

[0081] As shown in FIG13 , when the rotary valve is rotated 200 to 270 degrees, the valve liquid path 211 connects the first flow channel 1 and the eleventh flow channel 11, and the exhaust gas path 221 connects the tenth flow channel 10. The power source draws air, and the gas in the transfer chamber 110 enters the power source chamber 115 via the twenty-fifth flow channel 25. The eluent in the eluent chamber 107 enters the transfer chamber 110 via the eleventh flow channel 11, the valve liquid path 211, and the first flow channel 1. Simultaneously, the gas in the exhaust structure 212 enters the eluent chamber 107 via the exhaust gas path 221 and the tenth flow channel 10. Continuing with FIG9 , the rotary valve is then rotated 200 to 300 degrees, and the power source blows air, causing the eluent in the transfer chamber 110 to enter the magnetic bead liquid chamber 104 via the first flow channel 1, the valve liquid path 211, and the thirteenth flow channel 13.

[0082] As shown in FIG14 , when the rotary valve is rotated 200 to 330 degrees, the valve liquid path 211 connects the first flow channel 1 and the fifteenth flow channel 15, and the exhaust gas path 221 connects the fourteenth flow channel 14. The power source draws air, and the gas in the transfer chamber 110 enters the power source chamber 115 through the twenty-fifth flow channel 25. The rich solution in the rich solution chamber 108 enters the transfer chamber 110 through the fifteenth flow channel 15, the valve liquid path 211, and the first flow channel 1. Simultaneously, the gas in the exhaust structure 212 enters the rich solution chamber 108 through the exhaust gas path 221 and the fourteenth flow channel 14. Continuing with FIG9 , the rotary valve is then rotated 200 to 300 degrees, and the power source blows air, causing the rich solution in the transfer chamber 110 to enter the magnetic bead liquid chamber 104 through the first flow channel 1, the valve liquid path 211, and the thirteenth flow channel 13. The rotary valve 200 is kept at 300 degrees, the magnetic beads are attracted by the magnet mechanism, and the power source draws air to generate negative pressure, so that the set volume of the mixture of eluted nucleic acid and rich solution enters the transfer chamber 110 from the magnetic bead liquid chamber 104.

[0083] As shown in Figure 15, when the rotary valve 200 is rotated to 30 degrees, the valve liquid circuit 211 connects the first flow channel 1 and the eighteenth flow channel 18, and the exhaust gas circuit 221 connects the seventeenth flow channel 17; the power source blows air, and the gas in the power source chamber 115 enters the transfer chamber 110 through the twenty-fifth flow channel 25, and the rich solution product in the transfer chamber 110 enters the first PCR chamber 111 through the first flow channel 1, the valve liquid circuit 211, and the eighteenth flow channel 18 under the action of positive pressure; at the same time, the gas in the first PCR chamber 111 enters the exhaust structure 212 through the seventeenth flow channel 17 and the exhaust gas circuit 221.

[0084] Similarly, when the rotary valve is rotated 200 to 60 degrees, the valve liquid circuit 211 connects the first flow channel 1 and the twentieth flow channel 20, and the exhaust gas circuit 221 connects the nineteenth flow channel 19, and the rich-soluble product in the transfer chamber 110 enters the second PCR chamber 112 under the action of positive pressure; when the rotary valve is rotated 200 to 90 degrees, the valve liquid circuit 211 connects the first flow channel 1 and the twenty-second flow channel 22, and the exhaust gas circuit 221 connects the twenty-first flow channel 21, and the rich-soluble product in the transfer chamber 110 enters the third PCR chamber 113 under the action of positive pressure; when the rotary valve is rotated 200 to 120 degrees, the valve liquid circuit 211 connects the first flow channel 1 and the twenty-fourth flow channel 24, and the exhaust gas circuit 221 connects the twenty-third flow channel 23, and the rich-soluble product in the transfer chamber 110 enters the fourth PCR chamber 114 under the action of positive pressure. In this embodiment, the seventeenth flow channel 17, the eighteenth flow channel 18, the nineteenth flow channel 19, the twentieth flow channel 20, the twenty-first flow channel 21 and the twenty-second flow channel 22 are all provided with bending sections of a certain length to ensure that the flow path lengths of different PCR reactions are basically consistent.

Claims

1. A point-of-care test (POCT) cartridge, comprising: A cartridge body (100) is provided with a sample loading chamber (101), a sample processing chamber (102), a lysis liquid chamber (103), a magnetic bead liquid chamber (104), a cleaning liquid chamber (156), an elution liquid chamber (107), a rich solution chamber (108), a waste liquid chamber (109), a transfer chamber (110), a polymerase chain reaction (PCR) chamber (1234), a power source chamber (115) and a ventilation chamber (116); a back side of the cartridge body (100) is further provided with a plurality of flow channels communicating with the plurality of chambers; the sample loading chamber (101) is communicated with the top of the sample processing chamber (102); the ventilation chamber (116) is communicated with the sample loading chamber (101); the power source chamber (115) is configured to be connected to a power source; and the power source chamber (115) is communicated with the transfer chamber (110); A rotary valve (200) is rotatably mounted on the front side of the cartridge body (100), and the rotary valve (200) is provided with a valve liquid path (211), an exhaust gas path (221), and an exhaust structure (212); by rotating the rotary valve (200), the valve liquid path (211) can be selectively connected to a plurality of the flow channels, and at the same time, under the suction or blowing action of the power source, the sample in the sample loading chamber (101) can enter the transfer chamber (110) through the sample processing chamber (102), and then enter the sample processing chamber (102) from the transfer chamber (110); or the lysate in the lysate chamber (103) can enter the transfer chamber (110), and then enter the sample processing chamber (102) from the transfer chamber (110); Or the sample after lysis in the sample processing chamber (102) enters the transfer chamber (110), and then enters the magnetic bead liquid chamber (104) from the transfer chamber (110); or the waste liquid in the magnetic bead liquid chamber (104) enters the transfer chamber (110), and then enters the waste liquid chamber (109) from the transfer chamber (110); or the cleaning liquid in the cleaning liquid chamber (156) enters the transfer chamber (110), and then enters the magnetic bead liquid chamber (104) from the transfer chamber (110); or the cleaning liquid in the cleaning liquid chamber (156) enters the transfer chamber (110), and then enters the magnetic bead liquid chamber (104) from the transfer chamber (110); The elution liquid in the deliquescence chamber (107) enters the transfer chamber (110), and then enters the magnetic bead liquid chamber (104) from the transfer chamber (110); or the rich solution in the rich solution chamber (108) enters the transfer chamber (110), and then enters the magnetic bead liquid chamber (104) from the transfer chamber (110); or the mixed solution of the eluted nucleic acid and the rich solution in the magnetic bead liquid chamber (104) enters the transfer chamber (110), and then enters the PCR chamber (1234) from the transfer chamber (110).

2. The POCT test cartridge according to claim 1, wherein: The back of the cartridge body (100) is covered with a bottom sealing film (121), and the bottom sealing film (121) is configured to seal the chamber and flow channel on the back of the cartridge body (100); the front of the cartridge body (100) is covered with a top sealing film (122), and the top sealing film (122) is configured to seal the chamber on the front of the cartridge body (100); the side of the cartridge body (100) is covered with a side sealing film (123), and the side sealing film (123) is configured to seal the chamber on the side of the cartridge body (100); and the outside of the PCR cavity (1234) is covered with a PCR sealing film (124).

3. The POCT test cartridge according to claim 2, wherein: The rotary valve (200) comprises a valve base (210) and a valve soft rubber (220) arranged on the back of the valve base (210); the exhaust gas path (221) is arranged on the back of the valve soft rubber (220); the valve liquid path (211) and the exhaust structure (212) are arranged on the front of the valve base (210); the exhaust structure (212) is communicated with the exhaust gas path (221); and the valve liquid path (211) is covered with a valve sealing film (230).

4. The POCT test cartridge according to claim 1, wherein: Grinding beads and steel balls are selectively loaded into the sample processing chamber (102) according to the type of sample to be processed, and the grinding beads and steel balls are configured to grind the sample in the sample processing chamber (102).

5. The POCT test cartridge according to claim 2, wherein: The sample loading chamber (101) and the sample processing chamber (102) are arranged on the back of the card box body (100); the waste liquid chamber (109), the lysis liquid chamber (103), the cleaning liquid chamber (156), the elution liquid chamber (107) and the rich solution chamber (108) are arranged on the front of the card box body (100); the magnetic bead liquid chamber (104) and the transfer chamber (110) are arranged on the side of the card box body (100); and the PCR chamber (1234) is arranged on the front of the card box body (100).

6. The POCT test cartridge according to claim 5, wherein: The front of the cartridge body (100) is provided with an injection port (118) and a protective cover (119), wherein the injection port (118) is communicated with the sample loading chamber (101), and the protective cover (119) is reversibly connected to the cartridge body (100) for closing or opening the injection port (118).

7. The POCT test cartridge according to claim 3, wherein: A first ventilation filter membrane (125) is provided in the ventilation chamber (116), and a first filter membrane seal (126) is provided outside the first ventilation filter membrane (125); and / or a second ventilation filter membrane (240) is provided in the exhaust structure (212), and a second filter membrane seal (250) is provided outside the second ventilation filter membrane (240); and / or a power source filter element (127) is provided in the power source chamber (115); and / or the sample processing chamber (102) is also connected to the filter chamber (117), and a sample filter element (128) is provided in the filter chamber (117), and the sample filter element (128) is configured to filter the sample entering and exiting the sample processing chamber (102).

8. The POCT test cartridge according to claim 7, wherein: The bottom sealing film (121), the top sealing film (122), the side sealing film (123), the PCR sealing film (124) and the first filter membrane sealing film (126) are connected to the card box body (100) by heat melting or ultrasonic welding; the valve sealing film (230) and the second filter membrane sealing film (250) are connected to the rotary valve (200) by heat melting or ultrasonic welding.

9. The POCT test cartridge according to claim 1, wherein: The cartridge body (100) is provided with a mounting groove (129), the rotary valve (200) is rotatably mounted in the mounting groove (129), and the rotary valve (200) is axially limited by a buckle (130).

10. The POCT test cartridge according to claim 1, wherein: The cleaning liquid chamber (156) includes a first cleaning liquid chamber (105) and a second cleaning liquid chamber (106); the PCR chamber (1234) includes a first PCR chamber (111), a second PCR chamber (112), a third PCR chamber (113) and a fourth PCR chamber (114).

11. The POCT test cartridge according to claim 10, wherein: When the rotary valve (200) is at a first angle, the sample processing chamber (102) is in communication with the transfer chamber (110); When the rotary valve (200) is at a second angle, the transfer chamber (110) is in communication with the first PCR chamber (111); When the rotary valve (200) is at a third angle, the transfer chamber (110) is in communication with the second PCR chamber (112); When the rotary valve (200) is at a fourth angle, the transfer chamber (110) is in communication with the third PCR chamber (113); When the rotary valve (200) is at a fifth angle, the fourth PCR chamber (114) of the transfer chamber (110) is in communication; When the rotary valve (200) is at a sixth angle, the transfer chamber (110) is in communication with the waste liquid chamber (109); When the rotary valve (200) is at the seventh angle, the lysis liquid chamber (103) is connected to the transfer chamber (110); When the rotary valve (200) is at an eighth angle, the first cleaning liquid chamber (105) is in communication with the transfer chamber (110); When the rotary valve (200) is at a ninth angle, the second cleaning liquid chamber (106) is in communication with the transfer chamber (110); When the rotary valve (200) is at the tenth angle, the eluent chamber (107) is in communication with the transfer chamber (110); When the rotary valve (200) is at the eleventh angle, the transfer chamber (110) is in communication with the magnetic bead liquid chamber (104); When the rotary valve (200) is at the twelfth angle, the rich solution chamber (108) is connected to the transfer chamber (110).

12. A POCT detection device, comprising a POCT detection cartridge according to any one of claims 1 to 11, further comprising a power source, a heating mechanism, a magnet mechanism, a magnetic rotation mechanism and a valve drive mechanism, wherein the power source is connected to the power source chamber (115), the heating mechanism is configured to heat the sample in the sample processing chamber (102), the magnet mechanism is configured to adsorb the magnetic beads in the POCT detection cartridge, the magnetic rotation mechanism is configured to drive the steel balls in the detection cartridge, and the valve drive mechanism is configured to drive the rotary valve (200) to rotate.

13. A POCT detection method, using the POCT detection device according to claim 12, the POCT detection method comprising: Sample loading: rotating the rotary valve (200), the power source sucks air to generate negative pressure, so that the sample enters the transfer chamber (110) from the sample loading chamber (101) through the sample processing chamber (102); then the power source blows The gas generates positive pressure, so that all samples in the transfer chamber (110) enter the sample processing chamber (102); Lysis: the rotary valve (200) is rotated, and the power source sucks air to generate negative pressure, so that the lysate in the lysate chamber (103) enters the transfer chamber (110); then the rotary valve (200) is rotated, and the power source blows air to generate positive pressure, so that the lysate in the transfer chamber (110) enters the sample processing chamber (102), and the sample is processed by at least one of a heating method and a grinding method, so that the sample is lysed and the nucleic acid substance is released; Magnetic bead binding: the power source inhales air to generate negative pressure, so that the lysed sample enters the transfer chamber (110) from the sample processing chamber (102); then the rotary valve (200) is rotated, and the power source blows air to generate positive pressure, so that the lysed sample in the transfer chamber (110) enters the magnetic bead liquid chamber (104), and the magnetic beads are fully combined with the nucleic acid substance through magnetic bead stirring or air pump blowing; after the combination, the magnetic beads are adsorbed by the magnetic mechanism, and the power source inhales air to generate negative pressure, so that the waste liquid in the magnetic bead liquid chamber (104) enters the transfer chamber (110); then the rotary valve (200) is rotated, and the power source blows air to generate positive pressure, so that the waste liquid in the transfer chamber (110) enters the waste liquid chamber (109); Cleaning: the rotary valve (200) is rotated, and the power source sucks air to generate negative pressure, so that the cleaning liquid enters the transfer chamber (110) from the cleaning liquid chamber (156); then the rotary valve (200) is rotated, and the power source blows air to generate positive pressure, so that the cleaning liquid in the transfer chamber (110) enters the magnetic bead liquid chamber (104), and the nucleic acid material is cleaned by magnetic bead stirring or air pump blowing; after the cleaning is completed, the magnetic beads are adsorbed by the magnetic mechanism, and the power source sucks air to generate negative pressure, so that the waste liquid in the magnetic bead liquid chamber (104) enters the transfer chamber (110); then the rotary valve (200) is rotated, and the power source blows air to generate positive pressure, so that the waste liquid in the transfer chamber (110) enters the waste liquid chamber (109); Elution: the rotary valve (200) is rotated, and the power source inhales air to generate negative pressure, so that the eluent enters the transfer chamber (110) from the eluent chamber (107); the rotary valve (200) is rotated, and the power source blows air to generate positive pressure, so that the eluent in the transfer chamber (110) enters the magnetic bead liquid chamber (104), and the nucleic acid substance is eluted by magnetic bead stirring or air pump blowing; Mixing the nucleic acid with the rich solution: rotating the rotary valve (200), the power source sucks air to generate negative pressure, causing the rich solution to enter the transfer chamber (110) from the rich solution chamber (108); rotating the rotary valve (200), the power source blows air to generate positive pressure, causing the rich solution in the transfer chamber (110) to enter the magnetic bead liquid chamber (104), and mixing the nucleic acid substance and the rich solution; PCR reaction: the magnetic beads are adsorbed by the magnetic mechanism, and the power source sucks air to generate negative pressure, so that the mixed liquid of the eluted nucleic acid and the rich solution of the set volume enters the transfer chamber (110) from the magnetic bead liquid chamber (104); the rotary valve (200) is rotated, and the power source blows air to generate positive pressure, and the rich solution product of the preset volume in the transfer chamber (110) is transferred to the PCR chamber (1234), and the POCT detection equipment runs the PCR reaction system and performs PCR detection.

14. The POCT detection method according to claim 13, wherein: When the rotary valve (200) is at 0 degrees, the sample in the sample loading chamber (101) passes through the sample position. The processing chamber (102) enters the transfer chamber (110); and when the rotary valve (200) is at 0 degrees, the sample in the transfer chamber (110) is transferred to the sample processing chamber (102); When the rotary valve (200) is at 180 degrees, the lysate in the lysate chamber (103) is transferred to the transfer chamber (110); when the rotary valve (200) is at 0 degrees, the lysate in the transfer chamber (110) is transferred to the sample processing chamber (102); When the rotary valve (200) is at 0 degrees, the sample after lysis in the sample processing chamber (102) is transferred to the transfer chamber (110); when the rotary valve (200) is at 300 degrees, the sample after lysis in the transfer chamber (110) is transferred to the magnetic bead liquid chamber (104); When the rotary valve (200) is at 300 degrees, the waste liquid in the magnetic bead liquid chamber (104) is transferred into the transfer chamber (110); when the rotary valve (200) is at 150 degrees, the waste liquid in the transfer chamber (110) is transferred to the waste liquid chamber (109); When the rotary valve (200) is at 210 degrees, the first cleaning liquid in the first cleaning liquid chamber (105) is transferred to the transfer chamber (110); when the rotary valve (200) is at 300 degrees, the first cleaning liquid in the transfer chamber (110) is transferred to the magnetic bead liquid chamber (104); When the rotary valve (200) is at 240 degrees, the second cleaning liquid in the second cleaning liquid chamber (106) is transferred to the transfer chamber (110); when the rotary valve (200) is at 300 degrees, the second cleaning liquid in the transfer chamber (110) is transferred to the magnetic bead liquid chamber (104); When the rotary valve (200) is at 270 degrees, the eluate in the eluate chamber (107) is transferred to the transfer chamber (110); when the rotary valve (200) is at 300 degrees, the eluate in the transfer chamber (110) is transferred to the magnetic bead liquid chamber (104); When the rotary valve (200) is at 330 degrees, the rich solution in the rich solution chamber (108) is transferred to the transfer chamber (110); when the rotary valve (200) is at 300 degrees, the rich solution in the transfer chamber (110) is transferred to the magnetic bead liquid chamber (104); When the rotary valve (200) is at 300 degrees, the mixed solution of the eluted nucleic acid and the rich solution in the magnetic bead liquid chamber (104) is transferred into the transfer chamber (110); When the rotary valve (200) is at 30 degrees, the first preset volume of the rich solution in the transfer chamber (110) is transferred to the first PCR chamber (111); When the rotary valve (200) is at 60 degrees, the second preset volume of the enriched solution in the transfer chamber (110) is transferred to the second PCR chamber (112); When the rotary valve (200) is at 90 degrees, the third preset volume of the enriched solution in the transfer chamber (110) is transferred to the third PCR chamber (113); When the rotary valve (200) is at 120 degrees, the fourth preset volume of the rich solution in the transfer chamber (110) is transferred to the fourth PCR chamber (114).

Images