Liquid path system of sample analysis device, sample analysis device and sample analysis method

Abstract

The present invention discloses a liquid circuit system of a sample analysis device, a sample analysis device, and a sample analysis method. The liquid circuit system includes: a reagent collection liquid circuit, which is used to absorb the reagent and discharge the reagent into a reaction cup to add the reagent to the reaction cup; an original sample collection liquid circuit, which is used to absorb the original sample and discharge the original sample into the reaction cup; a test sample collection liquid circuit, which is used to absorb the test sample into the test sample collection liquid circuit, so that an optical detection device can detect the test sample; wherein the test sample is obtained from the original sample after a predetermined treatment, and the predetermined treatment at least includes: adding at least one of the reagents and performing at least one separation treatment; a separation liquid circuit, which is used to absorb the separated liquid after the separation treatment. In the above manner, the present invention can improve the detection efficiency of the sample analysis device and simplify the structure of its liquid circuit system.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a liquid path system of a sample analysis device, a sample analysis device, and a sample analysis method. Background Art

[0002] As people's awareness of their health grows, the demand for sample analysis devices is also increasing. Immunoassay analysis, in particular, has become a hot topic of research, placing correspondingly higher demands on the structure and performance of immunoassay devices. Immunoassay devices are medical testing instruments that perform immunoassays by testing serum. Their operating principle involves directly labeling a luminescent substance onto an antigen or antibody, or allowing an enzyme to act on a luminescent substrate. The luminescent substance is then catalyzed by a catalyst and oxidized by an oxidant to form an excited intermediate. When this excited intermediate returns to a stable ground state, it simultaneously emits photons. These emitted photons are measured by an optical signal detection module and, through signal processing, are ultimately converted into test results.

[0003] Existing immunoassay analyzers can only test separated samples and can only test one test item at a time. This requires sample pretreatment, results in long test cycles, and does not support simultaneous testing (i.e., testing multiple items at the same time). This results in low test efficiency and fails to meet the demand for efficient and rapid testing.

[0004] During a long period of research and development, the inventors of the present application discovered that existing immunoassay devices have low detection efficiency and complex fluid path structures. Summary of the Invention

[0005] The main technical problem solved by the present invention is to provide a liquid path system of a sample analysis device, a sample analysis device and a sample analysis method, which can improve the detection efficiency of a flow fluorescence immunoassay device and simplify the structure of its liquid path system.

[0006] In order to solve the above technical problems, a technical solution adopted by the present invention is to provide a liquid path system of a sample analysis device.

[0007] Wherein, the liquid circuit system includes:

[0008] A reagent collection liquid circuit, used to draw the reagent and then discharge the reagent into the reaction cup, so as to add the reagent into the reaction cup;

[0009] The original sample collection liquid path is used to absorb the original sample and then discharge the original sample into the reaction cup;

[0010] a test sample collection fluid path, for drawing the test sample into the test sample collection fluid path, so as to detect the test sample using an optical detection device; wherein the test sample is obtained from the original sample after undergoing a predetermined treatment, and the predetermined treatment at least includes: adding at least one of the reagents and performing at least one separation treatment;

[0011] The separation liquid path is used to absorb the separated liquid after the separation process.

[0012] In order to solve the above technical problems, a technical solution adopted by the present invention is to provide a sample analysis device.

[0013] Wherein, the device comprises:

[0014] Any of the above-mentioned fluid circuit systems, optical detection devices and control circuits.

[0015] In order to solve the above technical problems, a technical solution adopted by the present invention is to provide a sample analysis method.

[0016] Based on the sample analysis device described above, the liquid path system of the sample analyzer device includes a reagent collection liquid path, an original sample collection liquid path, a test sample collection liquid path and a separation liquid path;

[0017] The method comprises:

[0018] The reagent collection liquid path absorbs the reagent and then discharges the reagent into the reaction cup;

[0019] The original sample collection liquid path absorbs the original sample and then discharges the original sample into the reaction cup containing the reagent;

[0020] performing at least one pretreatment operation, wherein the pretreatment operation includes a separation process, and the separation liquid path draws the separated liquid after the separation process;

[0021] Repeating the steps of adding the reagent, performing the pretreatment, and performing the separation process to obtain a sample to be tested;

[0022] The sample collection fluid path draws the sample to be tested into the sample collection fluid path, so as to use an optical detection device to detect the sample to be tested.

[0023] The beneficial effects of the present invention are: different from the existing technology, the present invention completes the preparation of the sample to be tested through the cooperation of the reagent collection liquid circuit, the original sample collection liquid circuit and the separation liquid circuit. The sample collection liquid circuit mixes the sample to be tested and performs detection. The sample preparation process does not require the separation of the original sample, supports joint detection, and is conducive to improving detection efficiency; at the same time, the pipeline system is simplified, which is conducive to further shortening the detection cycle and reducing preparation costs. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for describing the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without inventive efforts. Among them:

[0025] Figure 1 This is a schematic structural diagram of an embodiment of a liquid path system of a sample analysis device according to the present invention;

[0026] Figure 2 It is a structural schematic diagram of another embodiment of a liquid path system of a sample analysis device of the present invention;

[0027] Figure 3 yes Figure 2 A partial enlarged view of the reagent collection liquid path 100;

[0028] Figure 4 yes Figure 2 A partial enlarged view of the original sample collection fluid path 200;

[0029] Figure 5 yes Figure 2 A partial enlarged view of the separation liquid path 300;

[0030] Figure 6 yes Figure 2 A partial enlarged view of the sample collection liquid path 400;

[0031] Figure 7 It is a structural schematic diagram of an embodiment of a sample analysis device of the present invention;

[0032] Figure 8 It is a flow chart of an embodiment of a sample analysis method of the present invention. DETAILED DESCRIPTION

[0033] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0034] See Figure 1 and Figure 2 , Figure 1 This is a structural diagram of an embodiment of a liquid path system of a sample analysis device according to the present invention. Figure 21 is a structural schematic diagram of another embodiment of a liquid circuit system of a sample analysis device of the present invention, the liquid circuit system comprising:

[0035] The reagent collection liquid circuit 100 is used to absorb the reagent and then discharge the reagent into the reaction cup to add the reagent to the reaction cup; the original sample collection liquid circuit 200 is used to absorb the original sample and then discharge the original sample into the reaction cup; the test sample collection liquid circuit 400 is used to absorb the test sample into the test sample collection liquid circuit so as to use an optical detection device to detect the test sample; wherein, the test sample is obtained by the original sample after a predetermined treatment, and the predetermined treatment at least includes: adding at least one of the reagents and performing at least one separation treatment; the separation liquid circuit 300 is used to absorb the separated liquid after the separation treatment.

[0036] In this embodiment, the reagent collection liquid circuit 100, the original sample collection liquid circuit 200 and the separation liquid circuit 300 cooperate to complete the preparation of the sample to be tested. The sample collection liquid circuit 400 mixes the sample to be tested and performs detection. The sample preparation process does not require separation of the original sample, supports joint testing, and is conducive to improving detection efficiency; at the same time, the pipeline system is simplified, which is conducive to further shortening the detection cycle and reducing preparation costs.

[0037] In this embodiment, the present embodiment supports joint testing because the reaction between the reagents is based on the principle of antigen-antibody specific binding, and after the reagents for different detection items are added to the same reaction cup, they will not affect each other. Therefore, joint testing of multiple detection items in the same reaction cup can be achieved, without the need to assign different items to different reaction cups. One reaction cup can complete the simultaneous incubation and detection of multiple detection items. Furthermore, the reagents include one or more of magnetic beads, antibodies, and fluorescent biotin. The original sample is a sample provided by the subject to be tested, including but not limited to whole blood, serum, etc. The sample to be tested is a sandwich structure including magnetic beads-antigen-antibody-fluorescent biotin. Furthermore, the test sample collection liquid path 400 is respectively connected to the waste liquid recovery tank 700 and the sheath liquid storage tank 500, the reagent collection liquid path 100 is respectively connected to the waste liquid recovery tank 700 and the cleaning liquid storage tank 600, the original sample collection liquid path 200 is respectively connected to the waste liquid recovery tank 700 and the sheath liquid storage tank 500, and the separation liquid path 300 is connected to the waste liquid recovery tank 700 and the cleaning liquid storage tank 600.

[0038] Furthermore, the sheath fluid storage tank 500 and the cleaning fluid storage tank 600 are each equipped with a liquid level detection device. When the liquid levels in the sheath fluid storage tank 500 and the cleaning fluid storage tank 600 are detected to be below a preset value, an alarm is issued to replenish the sheath fluid and the cleaning fluid. Of course, the waste liquid recovery tank 700 is also equipped with a liquid level detection device, which is used to alarm and prompt waste liquid removal when the liquid level in the waste liquid recovery tank 700 exceeds a preset height.

[0039] In one embodiment, please refer to Figure 3 , Figure 3 yes Figure 2 A partial enlarged view of the reagent collection liquid circuit 100, wherein the reagent collection liquid circuit includes: a reagent collection needle Z1, a first syringe ZS1, a second syringe ZS2, a first valve LV01, a second valve LV02, a third valve LV03 and a fourth valve LV04,

[0040] The first interface 011 of the first valve is connected to the injection port S11 of the first syringe, and the second interface 012 of the first valve is respectively connected to the cleaning liquid storage tank 600 and the second interface 042 of the fourth valve; the third interface 013 of the first valve is connected to the reagent collection needle Z1; the second valve LV02 is respectively connected to the side wall opening S12 of the first syringe and the third interface 033 of the third valve; the first interface 031 and the second interface 032 of the third valve are respectively connected to the second syringe ZS2 and the first interface 041 of the fourth valve; wherein, the injection port S11 of the first syringe is an opening arranged opposite to the piston of the first syringe, and the first interfaces of the first valve LV01, the third valve LV03 and the fourth valve LV04 are selectively connected to their respective second interfaces and third interfaces.

[0041] The reagent collection circuit 100 also includes a reagent collection needle drive mechanism (not shown), which drives the reagent collection needle Z1 into and out of the reagent chamber. The pistons of the first and second syringes ZS1 and ZS2 are connected to a drive mechanism QD10, which applies a push or pull force to the pistons of the first and second syringes ZS1 and ZS2.

[0042] During use, the reagent collection needle Z1, driven by the reagent collection needle drive mechanism, is lowered into the reagent. The first port 011 of the first valve selectively communicates with the third port 013 of the first valve. The second valve LV02 is a normally open valve. The first port 031 of the third valve selectively communicates with the third port 033 of the third valve. The pistons of the first and second syringes ZS1 and ZS2, under tension, create a negative pressure in the pipeline, drawing the reagent into the reagent collection needle Z1. When the pistons of the first and second syringes ZS1 and ZS2 push, creating a positive pressure in the pipeline, the reagent in the reagent collection needle Z1 is discharged into the reaction cup. In this embodiment, the reagent collection needle Z1 is also equipped with a sensor (not shown). A control device determines the depth of the reagent collection needle Z1's descent in advance based on the volume of the reagent bottle containing the reagent. The desired descent depth is sufficient to ensure the required amount of reagent is drawn, for example, 3 mm. When the sensor contacts the liquid surface, it causes a change in capacitance. When the capacitance reaches a preset value, indicating that the reagent collection needle Z1 has been immersed deep enough below the liquid surface to collect sufficient reagent, the needle Z1 stops descending. This simplifies the travel of the reagent collection needle Z1, shortens the reagent aspiration time, and further improves the detection efficiency of the detection device.

[0043] Furthermore, the reagent collection liquid circuit 100 also includes a reagent collection needle cleaning device C1 and a fifth valve LV05, the first interface 051 of the fifth valve is selectively connected to the third interface 043 of the fourth valve, the second interface 052 of the fifth valve is selectively connected to the liquid inlet C11 of the reagent collection needle cleaning device, and the liquid outlet C12 of the reagent collection needle cleaning device is connected to the waste liquid recovery tank 700; the first interface 051 of the fifth valve is selectively connected to the second interface 052 of the fifth valve and the third interface 053 of the fifth valve.

[0044] During use, the reagent collection needle cleaning device C1 is used to clean the reagent collection needle Z1. Specifically, the reagent collection needle Z1 is inserted into the reagent collection needle cleaning device C1 under the action of the reagent collection needle driving mechanism. The first interface 031 of the third valve selectively communicates with the third interface 033 of the third syringe, the first interface 041 of the fourth valve selectively communicates with the third interface 043 of the fourth valve, and the first interface 051 of the fifth valve selectively communicates with the second interface 052 of the fifth valve. Under the action of the thrust of the second syringe ZS2, the cleaning fluid contained in the second syringe ZS2 is injected into the reagent collection needle cleaning device C1 through the liquid inlet C11 of the reagent collection needle cleaning device, thereby cleaning the outer wall of the reagent collection needle Z1. Simultaneously, the first interface 011 of the first valve communicates with the third interface 013 of the first valve. Under the action of the thrust of the piston of the first syringe ZS1, the cleaning fluid contained in the first syringe ZS1 is injected into the reagent collection needle Z1, thereby cleaning the inner wall of the reagent collection needle Z1. The used cleaning liquid is discharged into the waste liquid recovery tank 700 through the liquid outlet C12 of the reagent collection needle cleaning device, the twentieth valve LV20, and the diaphragm pump P1.

[0045] Furthermore, when the first interface 011 of the first valve is selectively connected to the second interface 012 of the first valve, the first interface 031 of the third valve is selectively connected to the second interface 032 of the third valve, and the first interface 041 of the fourth valve is selectively connected to the second interface 042 of the fourth valve, the piston of the first syringe ZS1 and the piston of the second syringe ZS2 suck the cleaning fluid in the cleaning fluid storage tank 600 into the first syringe ZS1 and the second syringe ZS2 under the action of tension.

[0046] Furthermore, the piston of the first syringe ZS1 and the piston of the second syringe ZS2 are driven by the same drive mechanism. The capacity of the first syringe ZS1 is smaller than that of the second syringe ZS2. Furthermore, the capacity of the first syringe ZS1 is 100 microliters, while the capacity of the second syringe ZS2 is 2500 microliters. In this embodiment, the first syringe ZS1 and the second syringe ZS2 cause different pressure changes in the pipeline. The second syringe ZS2 performs coarse adjustments to the pressure in the pipeline by orders of magnitude, while the first syringe ZS1 performs fine adjustments to the pressure in the pipeline by specific values. The combination of a large-volume syringe and a small-volume syringe enables rapid and accurate control of the pressure in the pipeline and the volume of liquid transported therein, thereby improving operational efficiency.

[0047] In one embodiment, please refer to Figure 4 , Figure 4 yes Figure 2 A partial enlarged view of the original sample collection fluid circuit 200 is shown, which includes: an original sample collection needle Z2, a third syringe ZS3, a fourth syringe ZS4, a sixth valve LV06, a seventh valve LV07, and an eighth valve LV08. The first interface 071 of the seventh valve is connected to the injection port S31 of the third syringe, and the third interface 073 of the seventh valve is connected to the original sample collection needle Z2; the first interface 081 of the eighth valve is connected to the fourth syringe ZS4, and the second interface 082 of the eighth valve is connected to the cleaning fluid storage tank 600; the sixth valve LV06 is connected to the side wall opening S32 of the third syringe and the third interface 083 of the eighth valve, respectively; wherein the injection port S31 of the third syringe is an opening arranged opposite the piston of the third syringe ZS3, and the first interfaces of the seventh valve LV07 and the eighth valve LV08 are selectively connected to their respective second interfaces and third interfaces.

[0048] The primary sample collection fluid circuit 200 also includes a primary sample collection needle drive mechanism (not shown). The primary sample collection needle Z2 is driven by the primary sample collection needle drive mechanism (not shown) to enter and exit the primary sample collection chamber. The pistons of the third and fourth syringes ZS3 and ZS4 are connected to a drive mechanism QD20, which applies a push or pull force to the pistons of the third and fourth syringes ZS3 and ZS4.

[0049] During use, the original sample collection needle Z2 penetrates into the original sample tube under the action of the original sample collection needle driving mechanism, the first interface 071 of the seventh valve is communicated with the third interface 073 of the seventh valve, and the first interface 081 of the eighth valve is communicated with the third interface 083 of the eighth valve. The pistons of the third syringe ZS3 and the fourth syringe ZS4 form a negative pressure in the pipeline under the action of tension, and the original sample in the original sample tube is sucked into the original sample collection needle Z2. When the pistons of the third syringe ZS3 and the fourth syringe ZS4 form a positive pressure in the pipeline under the action of thrust, the original sample in the original sample collection needle Z2 is discharged into the reaction cup.

[0050] Furthermore, the third syringe ZS3 and the fourth syringe ZS4 are driven by the same drive device; the capacity of the third syringe ZS3 is smaller than that of the fourth syringe ZS4. Furthermore, the capacity of the third syringe ZS3 is 100 microliters, while the capacity of the fourth syringe ZS4 is 10 milliliters. In this embodiment, the third syringe ZS3 and the fourth syringe ZS4 cause different pressure changes in the pipeline. The fourth syringe ZS4 performs coarse pressure adjustment in the pipeline by orders of magnitude, while the third syringe ZS3 performs fine pressure adjustment in specific values. The combination of large-volume and small-volume syringes enables rapid and accurate control of the pressure in the pipeline and the volume of liquid transported therein, improving operational efficiency.

[0051] Furthermore, the original sample collection liquid circuit 200 also includes an original sample collection needle cleaning mechanism SZ sleeved on the outer periphery of the original sample collection needle Z2, and the first interface SZ1 and the second interface SZ2 of the original sample collection needle cleaning mechanism are respectively connected to the second interface 072 of the seventh valve and the waste liquid recovery tank 700.

[0052] During use, when the first port 071 of the seventh valve is connected to the second port 072 of the seventh valve, the piston of the third syringe ZS3, under the action of thrust, injects the sheath fluid contained in the third syringe ZS3 into the primary sample collection needle cleaning mechanism SZ through the first port SZ1 of the primary sample collection needle cleaning mechanism. During the relative movement between the primary sample collection needle cleaning mechanism SZ and the primary sample collection needle Z2, the outer wall of the primary sample collection needle Z2 is cleaned. When the opening in the side wall of the primary sample collection needle Z2 is positioned within the primary sample collection needle cleaning mechanism SZ, the first port 071 of the seventh valve is connected to the third port 073 of the seventh valve. Under the action of thrust, the piston of the third syringe ZS3 injects the sheath fluid contained in the third syringe ZS3 into the primary sample collection needle Z2, cleaning the inner wall of the primary sample collection needle Z2. The cleaned sheath fluid is then discharged from the second port SZ2 of the primary sample collection needle cleaning mechanism via the diaphragm pump P2 into the waste liquid recovery tank 700.

[0053] In addition, when the first interface 081 of the eighth valve is connected with the second interface 082 of the eighth valve, the piston of the fourth syringe ZS4 sucks the sheath fluid in the sheath fluid storage tank 500 into the fourth syringe ZS4 under the action of tension; and when the first interface 081 of the eighth valve is connected with the third interface 083 of the eighth valve, the fourth syringe ZS4 injects the sheath fluid contained in the fourth syringe ZS4 into the third syringe ZS3 under the action of piston thrust.

[0054] In one embodiment, please refer to Figure 5 , Figure 5 yes Figure 2 A partial enlarged view of the separation liquid circuit 300, wherein the separation liquid circuit 300 includes: a plunger pump B1, a cleaning needle Z4, a drainage needle Z3, a diaphragm pump P3, a ninth valve LV09 and a tenth valve LV10, wherein the drainage needle Z3 includes a long needle Z32 and a short needle Z31 arranged in a row, the first interface 091 of the ninth valve is connected to the plunger pump B1, the second interface 092 and the third interface 093 of the ninth valve are respectively connected to the cleaning liquid storage tank 600 and the first interface 101 of the tenth valve; the second interface 102 and the third interface 103 of the tenth valve are respectively connected to the cleaning needle Z4 and the short needle Z31; the diaphragm pump P3 is respectively connected to the waste liquid recovery tank 700 and the long needle Z32; wherein, the first interfaces of the ninth valve LV09 and the tenth valve LV10 are selectively connected to the second interface and the third interface respectively.

[0055] Furthermore, the separation liquid circuit further includes an isolation chamber G1, which is provided on the pipeline between the diaphragm pump P3 and the long needle Z32, and is communicated with the diaphragm pump P3 and the long needle Z32 respectively.

[0056] During use, the long needle Z32 is inserted into the appropriate position of the reaction cup after magnetic separation, the diaphragm pump P3 is turned on and the duty cycle parameter of the diaphragm pump is adjusted so that the liquid in the reaction cup after magnetic separation passes through the long needle Z32, the isolation chamber G1 and the diaphragm pump P3 and is further discharged into the waste liquid recovery tank 700. Afterwards, the diaphragm pump P3 is fully loaded to discharge the residual liquid in the isolation chamber G1. In this embodiment, the isolation chamber G1 is provided in the pipeline between the diaphragm pump P3 and the long needle Z32 to buffer and adjust the negative pressure of the pumping of the liquid, control the pumping force on the liquid within a certain range, avoid accidentally extracting the target magnetic beads, and further reduce the loss rate of the target magnetic beads.

[0057] Afterwards, the first interface 091 of the ninth valve is connected to the third interface 093 of the ninth valve, and the first interface 101 of the tenth valve is connected to the second interface 102 of the tenth valve. The plunger pump B1 injects the cleaning liquid contained in the plunger pump B1 into the reaction cup through the cleaning needle Z4 to stir and clean the target magnetic beads in the reaction cup after magnetic separation, and repeats the above-mentioned discharge process to a predetermined number of times to complete the cleaning of the target magnetic beads.

[0058] Furthermore, when the first port 091 of the ninth valve is connected to the second port 092 of the ninth valve and the plunger pump B1 is subjected to the pulling force of the drive mechanism QD30, the cleaning fluid in the cleaning fluid storage tank 600 is transferred to the plunger pump B1. Furthermore, when the first port 091 of the ninth valve is connected to the third port 093 of the ninth valve, and the first port 101 of the tenth valve is connected to the third port 103 of the tenth valve, the plunger pump B1, under the action of the thrust, discharges the cleaning fluid through the short needle Z31 to clean the outer wall of the long needle Z32.

[0059] In another embodiment, please refer to Figure 6 , Figure 6 yes Figure 2FIG2 is a partial enlarged view of the liquid circuit 400 for collecting the sample to be tested, wherein the liquid circuit 400 for collecting the sample to be tested comprises: a sample collection needle Z5, a fifth syringe ZS5, a sixth syringe ZS6, a flow chamber (not shown), a thirteenth valve LV13, a fourteenth valve LV14, a fifteenth valve LV15, a sixteenth valve LV16, and a seventeenth valve LV17. The sample flow tube 410 of the flow chamber is connected to the thirteenth valve LV13 and the fifteenth valve LV15, respectively. The side wall opening 421 of the sheath liquid flow tube 420 sleeved on the periphery of the sample flow tube 410 is connected to the fourteenth valve LV14, and the top opening 422 of the sheath liquid flow tube 420 is connected to the waste liquid recovery tank 700. The thirteenth valve LV13 is also connected to the sample flow tube 410. The sample collection circuit 400 is connected to the sample collection needle Z5; the fourteenth valve LV14 is also connected to the third port 173 of the seventeenth valve; the fifteenth valve LV15 is also connected to the injection port S51 of the fifth syringe; the sixteenth valve LV16 is respectively connected to the side wall opening S52 of the fifth syringe and the third port 173 of the seventeenth valve; the first port 171 of the seventeenth valve is connected to the sixth syringe ZS6, and the second port 172 of the seventeenth valve is connected to the sheath fluid storage tank 500. The injection port S51 of the fifth syringe is an opening opposite the piston of the fifth syringe ZS5, and the first port 171 of the seventeenth valve selectively connects to the second port 172 and the third port 173 of the seventeenth valve. Furthermore, the sample collection circuit 400 includes a drive mechanism QD40 and a drive mechanism QD50 connected to the piston of the fifth syringe ZS5 and the piston of the sixth syringe ZS6, respectively. The driving mechanism QD40 and the driving mechanism QD50 are used to apply a pushing force or a pulling force to the piston of the fifth syringe ZS5 and the piston of the sixth syringe ZS6, respectively.

[0060] During use, the first port 171 of the seventeenth valve is connected to the third port 173 of the seventeenth valve, the thirteenth valve LV13, the fifteenth valve LV15, and the sixteenth valve LV16 are in an open state. The pistons of the sixth syringe ZS6 and the fifth syringe ZS5, under the action of thrust, inject sheath fluid through the sample collection needle Z5 into the reaction cup containing the sample to be tested. The sheath fluid in the reaction cup is then repeatedly drawn into the sample collection needle Z5 through the fifth syringe ZS5 and / or the sixth syringe ZS6, and then discharged from the sample collection needle Z5 into the reaction cup to uniformly mix the sample to be tested. This aspiration and expulsion mixing method eliminates the need for a stirring rod or other structures, nor does it require the generation of positive pressure during bubble mixing. This simple structure improves detection efficiency.

[0061] In this embodiment, the sixth syringe ZS6 and the fifth syringe ZS5 are used to hold the sheath fluid, and their volumes differ. For example, the volume of the fifth syringe ZS5 is smaller than that of the sixth syringe ZS6. Accordingly, the sixth syringe ZS6 and the fifth syringe ZS5 cause different pressure changes in the pipeline. The sixth syringe ZS6 performs coarse adjustments to the pipeline pressure by orders of magnitude, while the fifth syringe ZS5 performs fine adjustments to the pipeline pressure by specific values. The combination of large-volume and small-volume syringes enables rapid and accurate control of the pipeline pressure and the volume of sheath fluid delivered, achieving excellent aspiration and mixing effects. Furthermore, the drive mechanism QD40 and the second drive mechanism QD50 drive the fifth and sixth syringes ZS5 and ZS6, respectively. Using separate drives allows for precise control of the respective driving forces and facilitates maintenance of the different drive mechanisms and syringes.

[0062] After the sample is evenly mixed, it can be tested. A pulling force is applied to the piston of the fifth syringe ZS5, drawing the sample into the pipeline between the thirteenth valve LV13 and the fifteenth valve LV15. The thirteenth and fifteenth valves LV13 and LV15 are then adjusted to a closed position, sealing the sample in the pipeline between the thirteenth and fifteenth valves LV13 and LV15. A thrust is applied to the piston of the fifth syringe ZS5, opening the fifteenth valve LV15 to allow the sample, entrained by the sheath fluid, to enter the sample flow tube 410. Simultaneously, the first port 171 of the seventeenth valve is connected to the third port 173 of the seventeenth valve. Under the action of the thrust, the piston of the sixth syringe ZS6 injects the sheath fluid through the sidewall opening 421 of the sheath fluid flow tube, filling the sheath fluid flow tube 420. At the outlet of the sample flow tube 410, sheath fluid filling the sheath fluid flow tube 420 surrounds the sample. At the top opening 422 of the sheath fluid flow tube, pressure forces the sheath fluid-encapsulated single particles of the sample through the detection area. Furthermore, the detection area is equipped with an optical detection device. In this embodiment, the mixing and detection processes of the sample are performed by the same mechanism, simplifying the device structure and improving detection efficiency.

[0063] Furthermore, the first port 171 of the seventeenth valve communicates with the second port 172 of the seventeenth valve, and the piston of the sixth syringe ZS6 is pulled, causing the sheath fluid in the sheath fluid storage tank 500 to enter the sixth syringe ZS6. After testing, the sample and sheath fluid are discharged into the waste liquid recovery tank 700 through the eighteenth valve LV18, the negative pressure generating device VAC, the nineteenth valve LV19, and the diaphragm pump P1.

[0064] For further information, please refer to Figure 2 、 Figure 3 、 Figure 4 and Figure 6 The liquid circuit system also includes: a sample collection needle cleaning device C2, a stirring rod cleaning device C3, an eleventh valve LV11 and a twelfth valve LV12. The eleventh valve LV11 is respectively connected to the third interface 173 of the seventeenth valve and the liquid inlet C21 of the sample collection needle cleaning device; the liquid inlet C31 of the stirring rod cleaning device is connected to the third interface 053 of the fifth valve; one interface of the twelfth valve LV12 is simultaneously connected to the discharge port C22 of the sample collection needle cleaning device and the discharge port C32 of the stirring rod cleaning device, and the other interface of the twelfth valve LV12 is connected to the waste liquid recovery tank 700.

[0065] In this embodiment, the first interface 171 of the seventeenth valve is connected to the third interface 173 of the seventeenth valve. Under the action of thrust, the piston of the sixth syringe ZS6 injects the sheath fluid contained in the sixth syringe ZS6 into the test sample collection needle cleaning device C2 through the liquid inlet C21 of the test sample collection needle cleaning device, and cleans the first device contained in the test sample collection needle cleaning device C2; ​​the first interface 031 of the third injection valve is connected to the second interface 32 of the third valve, the first interface 041 of the fourth valve is connected to the third interface 043 of the fourth valve, and the first interface 051 of the fifth valve is connected to the third interface 053 of the fifth valve. Under the action of thrust, the piston of the second syringe ZS2 injects the cleaning fluid contained in the second syringe ZS2 into the stirring rod cleaning device C3 through the liquid inlet C31 of the stirring rod cleaning device, and cleans the second device contained in the stirring rod cleaning device C3. The cleaned liquid flows out of the drain port C22 of the test sample collection needle cleaning device and the drain port C32 of the stirring rod cleaning device, and is then combined and injected into the waste liquid recovery tank 700 through the twelfth valve LV12 and the diaphragm pump P1. In this embodiment, the waste liquid flowing out of the drain port C22 of the test sample collection needle cleaning device and the drain port C32 of the stirring rod cleaning device are combined and discharged, which simplifies the pipeline structure for waste liquid discharge, helps reduce the number of pipelines in the test sample collection liquid circuit 400, further simplifies the device structure, and reduces the cost of the device.

[0066] In this embodiment, the components of the sheath fluid and the cleaning fluid may be the same or different. The first device and the second device may be independent devices or two devices connected together. In one embodiment, the first device is the test sample collection needle Z5, and the second device is a stirring rod for stirring the mixture in the reaction cup during the incubation process. The test sample collection needle Z5 and the stirring rod are mounted on the same mounting plate and driven by the same driving mechanism. At the same time, the distance between the test sample collection needle cleaning device C2 and the stirring rod cleaning device C3 matches the distance between the test sample collection needle Z5 and the stirring rod. In addition, the test sample collection needle cleaning device C2 and the stirring rod cleaning device C3 are symmetrically arranged along the driving mechanism, which can make the structure of the device more compact and is conducive to the miniaturization of the device.

[0067] In order to solve the above technical problems, the present invention adopts a technical solution: to provide a sample analysis device. Figure 7 , Figure 7This is a schematic diagram of the structure of one embodiment of a sample analysis device according to the present invention. The device 1 comprises any of the aforementioned fluidic system 10, an optical detection device 20, and a control circuit 30. In this embodiment, the optical detection device 20 includes a laser emitting device (not shown) and a beam collecting device (not shown). The laser emitting device emits laser light at the sample entrained in sheath fluid at the top opening 422 of the sheath fluid circulation tube 420. The beam collecting device collects the intensity of scattered light and fluorescence emitted by the sample under laser irradiation to further determine the classification and quantity of the sample.

[0068] In order to solve the above problem, a technical solution adopted by the present invention is to provide a sample analysis method.

[0069] Please refer to Figure 8 , Figure 8 It is a flow chart of an embodiment of a sample analysis method of the present invention, the method comprising the steps of:

[0070] S100. Provide an analysis device, wherein the fluid path system of the device includes a reagent collection fluid path, an original sample collection fluid path, a test sample collection fluid path, and a separation fluid path.

[0071] S200: The reagent collection liquid path absorbs the reagent and then discharges the reagent into the reaction cup.

[0072] In step S200, the reagents include at least one of magnetic beads, antibodies, and bioluminescent material. The magnetic beads are added first. The order in which the remaining reagents are added can be adjusted based on the actual operation process and is not limited here.

[0073] S300 , the original sample collection liquid path absorbs the original sample and then discharges the original sample into the reaction cup containing the reagent.

[0074] In step S300, the original sample may be a blood sample or other sample. Furthermore, the blood sample may be a whole blood sample or a serum sample, which is used to provide antigens.

[0075] S400 , performing at least one pretreatment operation, wherein the pretreatment operation includes a separation process, and the separation liquid path absorbs the separated liquid after the separation process.

[0076] In step S400, the pretreatment operation at least includes an incubation operation and a magnetic separation operation, and the magnetic separation operation at least includes drawing the separated liquid after the separation treatment through the separation liquid path.

[0077] S500 , repeating the steps of adding reagents, performing the pretreatment, and separating to obtain a sample to be tested.

[0078] In step S500, step S200 and step 400 are repeated, that is, step 400 needs to be performed each time the reagent is added until the sample to be tested is prepared. In this embodiment, the sample to be tested is a sandwich structure of magnetic beads-antigen-antibody-fluorescein.

[0079] S600 , the sample collection fluid path draws the sample to be tested into the sample collection fluid path, so as to use an optical detection device to detect the sample to be tested.

[0080] In step S600, the sample analysis performed on the sample to be tested may be an immunoassay, in particular, a chemifluorescence immunoassay performed using a flow device.

[0081] The above description is only an embodiment of the present invention and does not limit the patent scope of the present invention. Any equivalent structure or equivalent process transformation made by using the contents of the description and drawings of the present invention, or directly or indirectly applied in other related technical fields, are also included in the patent protection scope of the present invention.

Claims

1. A liquid path system of a sample analysis device, characterized in that: The fluid system comprises: a reagent collection fluid circuit, for sucking up the reagent and then discharging the reagent into a reaction cup, so as to add the reagent to the reaction cup; the reagent collection fluid circuit comprises a first syringe and a second syringe, wherein the capacity of the first syringe is smaller than that of the second syringe; The original sample collection liquid path is used to absorb the original sample and then discharge the original sample into the reaction cup; a test sample collection fluid path, for drawing the test sample into the test sample collection fluid path, so as to detect the test sample using an optical detection device; wherein the test sample is obtained from the original sample after undergoing a predetermined treatment, and the predetermined treatment at least includes: adding at least one of the reagents and performing at least one separation treatment; A separation liquid path, used for drawing the separated liquid after the separation process; The separation liquid path includes: a plunger pump, a cleaning needle, a drainage needle, a diaphragm pump, a ninth valve and a tenth valve, wherein the drainage needle includes a long needle and a short needle arranged in a row. The first interface of the ninth valve is connected to the plunger pump, and the second interface and the third interface of the ninth valve are connected to the cleaning liquid storage tank and the first interface of the tenth valve respectively; The second interface and the third interface of the tenth valve are respectively connected to the cleaning needle and the short needle; The diaphragm pump is connected to the waste liquid recovery tank and the long needle respectively; Wherein, the first interfaces of the ninth valve and the tenth valve are selectively connected to the second interface and the third interface respectively; The separation liquid path further includes an isolation chamber, which is provided on the pipeline between the diaphragm pump and the long needle and is communicated with the diaphragm pump and the long needle respectively.

2. The fluid circuit system according to claim 1, characterized in that: The test sample collection liquid path is connected to the waste liquid recovery tank and the sheath liquid storage tank respectively, the reagent collection liquid path is connected to the waste liquid recovery tank and the cleaning liquid storage tank respectively, the original sample collection liquid path is connected to the waste liquid recovery tank and the sheath liquid storage tank respectively, and the separation liquid path is connected to the waste liquid recovery tank and the cleaning liquid storage tank.

3. The fluid circuit system according to claim 2, characterized in that: The reagent collection liquid circuit also includes: a reagent collection needle, a first valve, a second valve, a third valve and a fourth valve, The first interface of the first valve is connected to the injection port of the first syringe, the second interface of the first valve is connected to the cleaning liquid storage tank and the second interface of the fourth valve respectively; the third interface of the first valve is connected to the reagent collection needle; The second valve is communicated with the side wall opening of the first syringe and the third interface of the third valve respectively; The first interface and the second interface of the third valve are respectively connected to the second syringe and the first interface of the fourth valve; The injection port of the first syringe is an opening arranged opposite to the piston of the first syringe, and the first interfaces of the first valve, the third valve and the fourth valve are selectively connected to the second interface and the third interface.

4. The fluid circuit system according to claim 3, characterized in that: The reagent collection liquid circuit also includes a reagent collection needle cleaning device and a fifth valve, the first interface of the fifth valve is connected to the third interface of the fourth valve, the second interface of the fifth valve is connected to the liquid inlet of the reagent collection needle cleaning device, and the liquid outlet of the reagent collection needle cleaning device is connected to the waste liquid recovery tank; The first interface of the fifth valve is selectively connected to the second interface of the fifth valve and the third interface of the fifth valve.

5. The fluid circuit system according to claim 4, characterized in that: The original sample collection liquid circuit includes: an original sample collection needle, a third syringe, a fourth syringe, a sixth valve, a seventh valve, and an eighth valve. The first interface of the seventh valve is connected to the injection port of the third syringe, and the third interface of the seventh valve is connected to the original sample collection needle; The first interface of the eighth valve is connected to the fourth syringe, and the second interface of the eighth valve is connected to the cleaning liquid storage tank; The sixth valve is communicated with the side wall opening of the third syringe and the third interface of the eighth valve respectively; The injection port of the third syringe is an opening arranged opposite to the piston of the third syringe, and the first interfaces of the seventh valve and the eighth valve are selectively connected to the second interface and the third interface.

6. The fluid circuit system according to claim 5, characterized in that: The capacity of the third syringe is smaller than that of the fourth syringe.

7. The fluid circuit system according to claim 6, characterized in that: The original sample collection liquid circuit further includes an original sample collection needle cleaning mechanism sleeved on the outer periphery of the original sample collection needle, wherein the first interface and the second interface of the original sample collection needle cleaning mechanism are respectively connected to the second interface of the seventh valve and the waste liquid recovery tank; The test sample collection liquid circuit includes a fifth syringe and a sixth syringe, and the volume of the fifth syringe is greater than that of the sixth syringe.

8. The fluid circuit system according to claim 7, characterized in that: The test sample collection liquid circuit further includes: a test sample collection needle, a flow chamber, a thirteenth valve, a fourteenth valve, a fifteenth valve, a sixteenth valve, and a seventeenth valve. The sample flow tube of the flow chamber is connected to the thirteenth valve and the fifteenth valve respectively, the side wall opening of the sheath liquid flow tube sleeved on the periphery of the sample flow tube is connected to the fourteenth valve, and the top opening of the sheath liquid flow tube is connected to the waste liquid recovery tank; The thirteenth valve is also connected to the sample collection needle to be tested; The fourteenth valve is also connected to the third interface of the seventeenth valve; The fifteenth valve is also connected to the injection port of the fifth syringe; The sixteenth valve is communicated with the side wall opening of the fifth syringe and the third interface of the seventeenth valve respectively; The first interface of the seventeenth valve is connected to the sixth syringe, and the second interface of the seventeenth valve is connected to the sheath fluid storage tank; The injection port of the fifth syringe is an opening arranged opposite to the piston of the fifth syringe, and the first interface of the seventeenth valve is selectively connected to the second interface of the seventeenth valve and the third interface of the seventeenth valve.

9. The fluid circuit system according to claim 8, characterized in that: The liquid circuit system also includes: a sample collection needle cleaning device, a stirring rod cleaning device, an eleventh valve and a twelfth valve, The eleventh valve is connected to the third interface of the seventeenth valve and the liquid inlet of the cleaning device for the sample collection needle to be tested respectively; The liquid inlet of the stirring rod cleaning device is connected to the third interface of the fifth valve; One interface of the twelfth valve is communicated with the drainage ports of the sample collection needle cleaning device and the stirring rod cleaning device at the same time, and the other interface of the twelfth valve is communicated with the waste liquid recovery tank.

10. A sample analysis device, characterized in that: The device comprises the liquid circuit system according to any one of claims 1 to 9, an optical detection device and a control circuit.

11. A sample analysis method, characterized in that: Based on the sample analysis device according to claim 10, the liquid path system of the sample analysis device includes a reagent collection liquid path, an original sample collection liquid path, a test sample collection liquid path and a separation liquid path; The method comprises: The reagent collection liquid path absorbs the reagent and then discharges the reagent into the reaction cup; The original sample collection liquid path absorbs the original sample and then discharges the original sample into the reaction cup containing the reagent; performing at least one pretreatment operation, wherein the pretreatment operation includes a separation process, and the separation liquid path draws the separated liquid after the separation process; Repeating the steps of adding the reagent, performing the pretreatment, and performing the separation process to obtain a sample to be tested; The sample collection fluid path draws the sample to be tested into the sample collection fluid path, so as to use an optical detection device to detect the sample to be tested.

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