CN110873704A

CN110873704A - Liquid path system of sample analyzer, and sample analyzing method

Info

Publication number: CN110873704A
Application number: CN201811012011.6A
Authority: CN
Inventors: 蔡佳; 刘治志
Original assignee: Shenzhen Dymind Biotechnology Co Ltd
Current assignee: Shenzhen Dymind Biotechnology Co Ltd
Priority date: 2018-08-31
Filing date: 2018-08-31
Publication date: 2020-03-10

Abstract

The invention discloses a liquid path system of a sample analysis device, the sample analysis device and a sample analysis method, wherein the liquid path system comprises: the reagent collecting liquid path is used for discharging the reagent to a reaction cup after the reagent is sucked so as to add the reagent into the reaction cup; the original sample collecting liquid path is used for sucking an original sample and then discharging the original sample to the reaction cup; the sample collection liquid path to be detected is used for sucking a sample to be detected into the sample collection liquid path to be detected so that an optical detection device can detect the sample to be detected; the sample to be detected is obtained by performing predetermined processing on the original sample, wherein the predetermined processing at least comprises the following steps: adding at least one of said reagents and performing at least one separation process; and a separation liquid path for sucking the separated liquid after the separation process. Through the mode, the detection efficiency of the sample analysis device can be improved, and the structure of a liquid path system of the sample analysis device can be simplified.

Description

Liquid path system of sample analyzer, and sample analyzing method

Technical Field

The present invention relates to the technical field of medical devices, and in particular, to a fluid path system of a sample analyzer, and a sample analyzing method.

Background

With the increasing concern of people on the health level, the demand of sample analyzers is increasing, and especially, the immunoassay of samples has become a research hotspot, and accordingly, higher requirements on the structure and performance of immunoassay analyzers are provided. An immunoassay device is a medical test instrument that performs immunoassay by detecting serum. The working principle is that the luminescent substance is directly marked on an antigen or an antibody, or acts on a luminescent substrate through enzyme, the luminescent substance is catalyzed by a catalyst and oxidized by an oxidant to form an excited intermediate, when the excited intermediate returns to a stable ground state, photons can be simultaneously emitted, the emitted photons are measured by an optical signal detection module, and the photons are finally converted into a detection result through signal processing.

In the prior art, an immunoassay analyzer can only detect a separated sample, and can only detect one item at the same time. Not only need carry out the preliminary treatment to the sample, the detection cycle length does not support the joint inspection yet, detects a plurality of projects simultaneously promptly, and detection efficiency is low, can not satisfy the demand that high-efficient quick detection.

In the long-term research and development process, the inventor of the application finds that the conventional immunoassay device has low detection efficiency and a complex liquid path structure.

Disclosure of Invention

The invention mainly solves the technical problem of providing a liquid path system of a sample analysis device, the sample analysis device and a sample analysis method, which can improve the detection efficiency of a flow type fluorescence immunoassay device and simplify the structure of the liquid path system.

In order to solve the technical problems, the invention adopts a technical scheme that: a fluid path system of a sample analyzer is provided.

Wherein, the liquid way system includes:

the reagent collecting liquid path is used for discharging the reagent to a reaction cup after the reagent is sucked so as to add the reagent into the reaction cup;

the original sample collecting liquid path is used for sucking an original sample and then discharging the original sample to the reaction cup;

the sample collection liquid path to be detected is used for sucking a sample to be detected into the sample collection liquid path to be detected so as to detect the sample to be detected by using an optical detection device; the sample to be detected is obtained by performing predetermined processing on the original sample, wherein the predetermined processing at least comprises the following steps: adding at least one of said reagents and performing at least one separation process;

and a separation liquid path for sucking the separated liquid after the separation process.

In order to solve the technical problems, the invention adopts a technical scheme that: a sample analyzer is provided.

Wherein the apparatus comprises:

any of the liquid path system, the optical detection device and the control circuit.

In order to solve the technical problems, the invention adopts a technical scheme that: a method of sample analysis is provided.

The method comprises the following steps:

providing an analysis device, wherein a liquid path system of the device comprises a reagent collecting liquid path, an original sample collecting liquid path, a sample collecting liquid path to be detected and a separation liquid path;

the reagent collecting liquid path sucks a reagent and then discharges the reagent to the reaction cup;

the original sample collecting liquid path sucks an 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 comprises separation treatment, and the separation liquid path absorbs the separated liquid after the separation treatment;

repeating the reagent adding, the pretreatment operation and the separation operation to obtain a sample to be detected;

and the sample collecting liquid path to be detected absorbs a sample to be detected to the sample collecting liquid path to be detected so as to detect the sample to be detected by using an optical detection device.

The invention has the beneficial effects that: different from the situation of the prior art, the preparation of the sample to be detected is completed through the matching of the reagent collecting liquid path, the original sample collecting liquid path and the separating liquid path, the sample to be detected is mixed and detected by the sample collecting liquid path, the original sample is not required to be separated in the sample preparation process, joint detection is supported, and the detection efficiency is improved; meanwhile, the pipeline system is simplified, which is beneficial to further shortening the detection period and reducing the preparation cost.

Drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings needed to be used in the description of the embodiments will be briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts. Wherein:

FIG. 1 is a schematic diagram of a fluid path system of a sample analyzer according to an embodiment of the present invention;

FIG. 2 is a schematic structural view of a fluid path system of a sample analyzer according to another embodiment of the present invention;

FIG. 3 is an enlarged partial view of the reagent collection well 100 of FIG. 2;

FIG. 4 is an enlarged partial view of the primary sample acquisition fluid path 200 of FIG. 2;

FIG. 5 is an enlarged view of a portion of the separation channel 300 of FIG. 2;

fig. 6 is a partially enlarged view of the sample collection path 400 of fig. 2;

FIG. 7 is a schematic structural view of one embodiment of a sample analyzer of the present invention;

FIG. 8 is a schematic flow chart diagram of one embodiment of a sample analysis method according to the present invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Referring to fig. 1 and 2, fig. 1 is a schematic structural view of an embodiment of a fluid path system of a sample analyzer according to the present invention, and fig. 2 is a schematic structural view of another embodiment of a fluid path system of a sample analyzer according to the present invention, the fluid path system including:

a reagent collection path 100 for sucking a reagent and discharging the reagent into a reaction cup to add the reagent into the reaction cup; an original sample collection path 200 for sucking an original sample and discharging the original sample to the cuvette; a sample collection path 400 for sucking a sample to be detected into the sample collection path for detection of the sample to be detected using an optical detection device; the sample to be detected is obtained by performing predetermined processing on the original sample, wherein the predetermined processing at least comprises the following steps: adding at least one of said reagents and performing at least one separation process; a separation liquid path 300 for sucking the separated liquid after the separation process.

In this embodiment, the reagent collection liquid path 100, the original sample collection liquid path 200, and the separation liquid path 300 cooperate to complete the preparation of the sample to be detected, the sample to be detected is mixed and detected by the sample collection liquid path 400, the original sample does not need to be separated in the process of preparing the sample, joint detection is supported, and the detection efficiency is improved; meanwhile, the pipeline system is simplified, which is beneficial to further shortening the detection period and reducing the preparation cost.

In the embodiment, the joint inspection is supported by the embodiment because the reaction of the reagents is based on the antigen-antibody specific binding principle, and different detection item reagents are added into the same reaction cup without affecting each other, so that the joint inspection of a plurality of detection items in the same reaction cup can be realized, different items do not need to be distributed to different reaction cups, and one reaction cup can finish the simultaneous incubation and detection of a plurality of detection items. Further, the reagent comprises one or more of magnetic beads, antibodies and fluorescent biotin. The original sample is a sample provided by a subject to be tested, and includes but is not limited to whole blood, serum and the like. The sample to be detected is of a sandwich structure comprising magnetic beads, antigen, antibody and fluorescent biotin. Further, the sample collection liquid way 400 that awaits measuring communicates with waste liquid recovery jar 700 and sheath liquid storage jar 500 respectively, reagent collection liquid way 100 respectively with waste liquid recovery jar 700 and washing liquid storage jar 600 intercommunication, original sample collection liquid way 200 respectively with waste liquid recovery jar 700 with sheath liquid storage jar 500 intercommunication, separation liquid way 300 with waste liquid recovery jar 700 with washing liquid storage jar 600 intercommunication.

Further, sheath liquid storage jar 500 with washing liquid storage jar 600 is equipped with liquid level detection device respectively, when detecting sheath liquid storage jar 500 with the liquid level of washing liquid storage jar 600 is less than the default, then reports to the police and supplys sheath liquid with the washing liquid. Of course, the waste liquid recovery tank 700 is also provided with a liquid level detection device for alarming and reminding the waste liquid cleaning when the liquid level of the waste liquid recovery tank 700 exceeds the preset height.

In one embodiment, referring to fig. 3, fig. 3 is a partial enlarged view of the reagent collection circuit 100 of fig. 2, the reagent collection circuit comprising: a reagent collecting needle Z1, a first injector ZS1, a second injector ZS2, a first valve LV01, a second valve LV02, a third valve LV03 and a fourth valve LV04,

the first port 011 of the first valve is communicated with the injection port S11 of the first syringe, and the second port 012 of the first valve is respectively communicated with the cleaning solution storage tank 600 and the second port 042 of the fourth valve; the third port 013 of the first valve is in communication with the reagent collection needle Z1; the second valve LV02 communicates with the side wall opening S12 of the first syringe and the third port 033 of the third valve, respectively; the first port 031 and the second port 032 of the third valve are respectively communicated with the second syringe ZS2 and the first port 041 of the fourth valve; the injection port S11 of the first injector is an opening disposed opposite to the piston of the first injector, and the first port of each of the first valve LV01, the third valve LV03 and the fourth valve LV04 is selectively communicated with the second port of each of the first valve LV01, the third valve LV03 and the third port of each of the fourth valve LV 04.

In addition, the fluid path 100 further includes a reagent collection needle driving mechanism, and the reagent collection needle Z1 is driven by the reagent collection needle driving mechanism (not shown) to enter and exit the reagent to be treated. And the piston of the first syringe ZS1 and the piston of the second syringe ZS2 are connected with a driving mechanism QD10, and the driving mechanism QD10 is used for applying pushing force or pulling force to the piston of the first syringe ZS1 and the piston of the second syringe ZS 2.

In use, the collecting needle Z1 is driven by the reagent collecting needle driving mechanism to penetrate into the reagent, the first port 011 of the first valve is selectively communicated 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 is selectively communicated with the third port 033 of the third valve, the plunger of the first syringe ZS1 and the plunger of the second syringe ZS2 generate negative pressure in the pipeline under the action of pulling force, and the reagent is sucked into the reagent collecting needle Z1. And when the piston of the first syringe ZS1 and the piston of the second syringe ZS2 are subjected to the thrust force to form positive pressure in the pipeline, the reagent in the reagent collecting needle Z1 is discharged into the reaction cup. In this embodiment, the reagent collecting needle Z1 is further provided with a sensor (not shown), and the control device determines the descending depth of the reagent collecting needle Z1 in advance according to the volume of the reagent bottle containing the reagent, wherein the descending depth can ensure that the required reagent is sucked, for example, the reagent is descended by 3 mm. When the sensor contacts the liquid surface, a change in capacitance is caused, and when the capacitance reaches a preset value, indicating that the reagent collection needle Z1 has been submerged to a preset depth below the liquid surface to obtain sufficient reagent, the reagent collection needle Z1 is caused to stop descending. This can simplify the stroke of the reagent collection needle Z1, shorten the reagent aspiration time, and further improve the detection efficiency of the detection device.

Further, the reagent collection liquid path 100 further includes a reagent collection needle cleaning device C1 and a fifth valve LV05, the first port 051 of the fifth valve is selectively communicated with the third port 043 of the fourth valve, the second port 052 of the fifth valve is selectively communicated with the liquid inlet C11 of the reagent collection needle cleaning device, and the liquid outlet C12 of the reagent collection needle cleaning device is communicated with the waste liquid storage tank 700; the first interface 051 of the fifth valve is selectively communicated with the second interface 052 of the fifth valve and the third interface 053 of the fifth valve.

During use, the reagent collection needle cleaning device C1 is used to clean the reagent collection needle Z1. Specifically, the reagent collecting needle Z1 penetrates into the reagent collecting needle cleaning device C1 under the action of the reagent collecting needle driving mechanism, the first interface 031 of the third valve is selectively communicated with the third interface 033 of the third injector, the first interface 041 of the fourth valve is selectively communicated with the third interface 043 of the fourth valve, the first interface 051 of the fifth valve is selectively communicated with the second interface 052 of the fifth valve, and the second injector ZS2 injects the cleaning solution contained in the second injector ZS2 into the reagent collecting needle cleaning device C1 through the liquid inlet C11 of the reagent collecting needle cleaning device under the action of thrust to clean the outer wall of the reagent collecting needle Z1. Meanwhile, the first port 011 of the first valve is communicated with the third port 013 of the first valve, and the plunger of the first syringe ZS1 injects the cleaning solution contained in the first syringe ZS1 into the reagent collection needle Z1 under the pushing force to clean the inner wall of the reagent collection needle Z1. And the used cleaning liquid is discharged into the waste liquid storage tank 700 through the liquid outlet C12 of the reagent collecting needle cleaning device, the twentieth valve LV20 and the plunger pump P1.

Further, when the first port 011 of the first valve selectively communicates with the second port 012 of the first valve, the first port 031 of the third valve selectively communicates with the second port 032 of the third valve, and the first port 041 of the fourth valve selectively communicates with the second port 042 of the fourth valve, the plunger of the first syringe ZS1 and the plunger of the second syringe ZS2 draw the cleaning solution in the cleaning solution storage tank 600 into the first syringe ZS1 and the second syringe ZS 2.

Furthermore, the piston of the first injector ZS1 and the piston of the second injector ZS2 are driven by the same driving mechanism, the capacity of the first injector ZS1 is smaller than that of the second injector ZS2, further, the capacity of the first injector ZS1 is 100 microliters, and the capacity of the second injector ZS2 is 2500 microliters. In the embodiment, the first injector ZS1 and the second injector ZS2 enable the pressure in the pipeline to change in different ranges, the second injector ZS2 performs coarse adjustment on the pressure in the pipeline in an order of magnitude, the first injector ZS1 performs fine adjustment on the pressure in the pipeline in a specific numerical value, and the large-volume injector and the small-volume injector are combined to quickly and accurately control the pressure in the pipeline and the volume of liquid conveyed in the pipeline, so that the operation efficiency is improved.

In one embodiment, referring to fig. 4, fig. 4 is a partial enlarged view of the original sample collection fluid path 200 of fig. 2, wherein the original sample collection fluid path 200 comprises: a primary 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, wherein a first interface 071 of the seventh valve is communicated with an injection port S31 of the third syringe, and a third interface 073 of the seventh valve is communicated with the primary sample collection needle Z2; the first port 081 of the eighth valve is in communication with the fourth syringe ZS4, and the second port 082 of the eighth valve is in communication with the cleaning solution storage tank 600; the sixth valve LV06 is respectively communicated with the lateral wall opening S32 of the third syringe and the third port 083 of the eighth valve; the injection port S31 of the third injector is an opening arranged opposite to the piston of the third injector ZS3, and the first ports of the seventh valve LV07 and the eighth valve LV08 are selectively communicated with the second ports and the third ports respectively.

In addition, the fluid circuit 200 includes a primary sample collection needle drive mechanism, and the primary sample collection needle Z2 is driven by the primary sample collection needle drive mechanism (not shown) into and out of the primary sample to be collected. And the plunger of the third syringe ZS3 and the plunger of the fourth syringe ZS4 were connected with a driving mechanism QD20, and the driving mechanism QD20 was used for applying pushing or pulling force to the plunger of the third syringe ZS3 and the plunger of the fourth syringe ZS 4.

In use, the original sample collecting needle Z2 is driven by the original sample collecting needle driving mechanism to penetrate into an original sample tube, the first interface 071 of the seventh valve is communicated with the third interface 073 of the seventh valve, the first interface 081 of the eighth valve is communicated with the third interface 083 of the eighth valve, and the piston of the third syringe ZS3 and the piston of the fourth syringe ZS4 are driven by tensile force to form negative pressure in the pipeline so as to suck the original sample in the original sample tube into the original sample collecting needle Z2; when the piston of the third syringe ZS3 and the piston of the fourth syringe ZS4 generate positive pressure in the pipeline under the action of the pushing force, the original sample in the original sample collecting needle Z2 is discharged into the reaction cup.

In addition, the third injector ZS3 and the fourth injector ZS4 are driven by the same driving device; the capacity of the third injector ZS3 is smaller than that of the fourth injector ZS4, further, the capacity of the third injector ZS3 is 100 microliters, and the capacity of the fourth injector ZS4 is 10 milliliters. In the embodiment, the third injector ZS3 and the fourth injector ZS4 enable the pressure in the pipeline to change in different ranges, the fourth injector ZS4 performs coarse adjustment on the pressure in the pipeline in an order of magnitude, the third injector ZS3 performs fine adjustment on the pressure in the pipeline in a specific numerical value, and the combination of a large-volume injector and a small-volume injector can quickly and accurately control the pressure in the pipeline and the volume of liquid conveyed in the pipeline, so that the operation efficiency is improved.

Further, the original sample collection liquid path 200 further includes an original sample collection needle cleaning mechanism SZ sleeved on the periphery of the original sample collection needle Z2, and a first interface SZ1 and a second interface SZ2 of the original sample collection needle cleaning mechanism are respectively communicated with the second interface 072 of the seventh valve and the waste liquid storage tank 700.

In use, when the first port 071 of the seventh valve is in communication with the second port 072 of the seventh valve, the plunger of the third syringe ZS3 pushes the sheath fluid contained in the third syringe ZS3 through the first port SZ1 of the primary sample collection needle cleaning mechanism into the primary sample collection needle cleaning mechanism SZ, and cleans the outer wall of the primary sample collection needle Z2 during the relative movement between the primary sample collection needle cleaning mechanism SZ and the primary sample collection needle Z2. When the opening of the sidewall of the primary sample collection needle Z2 is placed in the primary sample collection needle cleaning mechanism SZ, the first connector 071 of the seventh valve is communicated with the third connector 073 of the seventh valve, and the plunger of the third syringe ZS3 is pushed to inject the sheath fluid contained in the third syringe ZS3 into the primary sample collection needle Z2, so as to clean the inner wall of the primary sample collection needle Z2. And the cleaned sheath fluid is discharged from the second port SZ2 of the original sample collection needle cleaning mechanism into the waste fluid storage tank 700 through the diaphragm pump P2.

In addition, when the first port 081 of the eighth valve is communicated with the second port 082 of the eighth valve, the piston of the fourth syringe ZS4 draws the sheath fluid in the sheath fluid storage tank 500 into the fourth syringe ZS 4; and when the first port 081 of the eighth valve is communicated with the third port 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 thrust of the piston.

In one embodiment, referring to fig. 5, fig. 5 is a partial enlarged view of the separation liquid path 300 in fig. 2, wherein the separation liquid path 300 includes: the cleaning device comprises a plunger pump B1, a cleaning needle Z4, a liquid discharge needle Z3, a diaphragm pump P3, a ninth valve LV09 and a tenth valve LV10, wherein the liquid discharge needle Z3 comprises a long needle Z32 and a short needle Z31 which are arranged in rows, a first port 091 of the ninth valve is communicated with the plunger pump B1, and a second port 092 and a third port 093 of the ninth valve are respectively communicated with the cleaning liquid storage tank 600 and a first port 101 of the tenth valve; the second interface 102 and the third interface 103 of the tenth valve are respectively communicated with the cleaning needle Z4 and the short needle Z31; the diaphragm pump P3 is respectively communicated with the waste liquid storage tank 700 and the long needle Z32; wherein the first ports of the ninth valve LV09 and the tenth valve LV10 are selectively communicated with the second ports and the third ports respectively.

Further, the separation liquid path further includes an isolation chamber G1, and the isolation chamber G1 is disposed on a pipeline between the diaphragm pump P3 and the long needle Z32 and is respectively communicated with the diaphragm pump P3 and the long needle Z32.

During use, the long needle Z32 is inserted into the magnetically separated reaction cup at a proper position, a diaphragm pump P3 is opened and the duty ratio parameter of the diaphragm pump is adjusted, so that the liquid in the magnetically separated reaction cup passes through the long needle Z32, the isolation chamber G1 and the diaphragm pump P3 and is further discharged into the waste liquid storage tank 700, and then the diaphragm pump P3 is fully operated to discharge the residual liquid in the isolation chamber G1. In this embodiment, the isolation chamber G1 is provided in the line between the diaphragm pump P3 and the long needle Z32, and the pumping force of the liquid is controlled within a certain range by adjusting the negative pressure of the pumping of the liquid, thereby preventing the target magnetic beads from being extracted by mistake and further reducing the loss rate of the target magnetic beads.

Then, the first port 091 of the ninth valve is communicated with the third port 093 of the ninth valve, the first port 101 of the tenth valve is communicated with the second port 102 of the tenth valve, and the plunger pump B1 injects the cleaning solution 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 the magnetic separation, and repeats the above-mentioned liquid discharge process for a predetermined number of times, thereby completing the cleaning of the target magnetic beads.

In addition, when the first port 091 of the ninth valve is communicated with the second port 092 of the ninth valve and the plunger pump B1 is pulled by the driving mechanism QD30, the cleaning solution in the cleaning solution storage apparatus 600 is transferred to the plunger pump B1. And when the first port 091 of the ninth valve is communicated with the third port 093 of the ninth valve and the first port 101 of the tenth valve is communicated with the third port 103 of the tenth valve, the plunger pump B1 discharges the cleaning liquid through the short needle Z31 under the pushing force to clean the outer wall of the long needle Z32.

In another embodiment, referring to fig. 6, fig. 6 is a partial enlarged view of the sample collection circuit 400 to be tested in fig. 2, wherein the sample collection circuit 400 to be tested includes: a sample collecting needle Z5 for a sample to be tested, a fifth syringe ZS5, a sixth syringe ZS6, a flow chamber (not labeled), a thirteenth valve LV13, a fourteenth valve LV14, a fifteenth valve LV15, a sixteenth valve LV16 and a seventeenth valve LV17, wherein the sample flow tube 410 for a sample to be tested in the flow chamber is respectively communicated with the thirteenth valve LV13 and the fifteenth valve LV15, a side wall opening 421 of a sheath fluid flow tube 420 sleeved on the periphery of the sample flow tube 410 for a sample to be tested is communicated with the fourteenth valve LV14, and a top opening 422 of the sheath fluid flow tube 420 is communicated with the waste liquid storage tank 700; the thirteenth valve LV13 is also communicated with the sample collecting needle Z5 to be tested; the fourteenth valve LV14 is further communicated with the third interface 173 of the seventeenth valve; the fifteenth valve LV15 is also in communication with the injection port S51 of the fifth syringe; the sixteenth valve LV16 is in communication with the sidewall opening S52 of the fifth injector and the third port 173 of the seventeenth valve, respectively; the first port 171 of the seventeenth valve is communicated with the sixth injector ZS6, and the second port 172 of the seventeenth valve is communicated with the sheath fluid storage tank 500; the injection port S51 of the fifth injector is an opening opposite to the piston of the fifth injector ZS5, and the first port 171 of the seventeenth valve is selectively communicated with the second port 172 of the seventeenth valve and the third port 173 of the seventeenth valve. In addition, the fluid circuit 400 further comprises a driving mechanism QD40 and a driving mechanism QD50 which are respectively connected with the piston of the fifth syringe ZS5 and the piston of the sixth syringe ZS 6. The driving mechanism QD40 and the driving mechanism QD50 are used for applying pushing force or pulling force to the piston of the fifth syringe ZS5 and the piston of the sixth syringe ZS6 respectively.

In use, the first port 171 of the seventeenth valve is communicated with 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 plunger of the sixth injector ZS6 and the plunger of the fifth injector ZS5 inject sheath fluid into the reaction cup containing the sample to be tested through the sample collecting needle Z5 under thrust, and repeatedly suck the sheath fluid in the reaction cup into the sample collecting needle Z5 through the fifth injector ZS5 and/or the sixth injector ZS6, and spit the sheath fluid out of the sample collecting needle Z5 to the reaction cup to uniformly mix the sample to be tested. The sample to be detected is uniformly mixed by adopting a sucking, spitting and uniformly mixing mode without structures such as a stirring rod and the like, and without positive pressure generated in the bubble uniformly mixing process, the structure is simple, and the detection efficiency is favorably improved.

In this embodiment, the sixth syringe ZS6 and the fifth syringe ZS5 can be used to contain the sheath fluid, and the volumes of the two syringes are different, for example, the volume of the fifth syringe ZS5 is smaller than the volume of the sixth syringe ZS6, correspondingly, the sixth syringe ZS6 and the fifth syringe ZS5 make the magnitude of the pressure change in the pipeline different, the sixth syringe ZS6 performs coarse adjustment on the pressure in the pipeline, the fifth syringe ZS5 performs fine adjustment on the pressure in the pipeline by a specific value, and the combination of the large-volume syringe and the small-volume syringe can rapidly and accurately control the magnitude of the pressure in the pipeline and the volume of the sheath fluid conveyed in the pipeline, so as to obtain better sucking, spitting and mixing effects. Furthermore, the driving mechanism QD40 and the second driving mechanism QD50 are respectively driven by the fifth syringe ZS5 and the sixth syringe ZS6, the magnitude of the respective driving force can be accurately controlled by adopting a single driving mode, and the overhaul of different driving mechanisms and different syringes is facilitated.

And after the samples to be detected are uniformly mixed, the uniformly mixed samples to be detected can be detected. And applying a pulling force to a piston of the fifth injector ZS5, sucking the sample to be tested into a pipeline between the thirteenth valve LV13 and the fifteenth valve LV15, and adjusting the thirteenth valve LV13 and the fifteenth valve LV15 to a stop state, so that the sample to be tested is sealed on the pipeline between the thirteenth valve LV13 and the fifteenth valve LV 15. Applying a pushing force to the piston of the fifth syringe ZS5, and opening the fifteenth valve LV15 to clamp the sample to be tested in the sheath fluid and enter the flow tube 410 of the sample to be tested; meanwhile, the first port 171 of the seventeenth valve is communicated with the third port 173 of the seventeenth valve, and the piston of the sixth syringe ZS6 injects the sheath fluid through the side wall opening 421 of the sheath fluid flowing tube under the pushing force to fill the sheath fluid flowing tube 420. At the outlet of the sample flow tube 410 to be detected, the sheath fluid filled in the sheath fluid flow tube 420 wraps the sample to be detected, and at the top opening 422 of the sheath fluid flow tube, the single particles of the sample to be detected wrapped by the sheath fluid are forced to pass through the detection area under the action of pressure. Further, the detection area is provided with an optical detection device. In this embodiment, the blending operation of the sample to be detected and the detection process of the sample to be detected are completed by the same mechanism, which is beneficial to simplifying the structure of the device and improving the detection efficiency.

In addition, the first port 171 of the seventeenth valve is communicated with the second port 172 of the seventeenth valve and the piston of the sixth injector ZS6 is pulled, so that the sheath fluid in the sheath fluid storage tank 500 enters the sixth injector ZS 6. The sample to be tested and the sheath fluid are discharged into the waste liquid storage tank 700 through an eighteenth valve LV18, a negative pressure generating device VAC, a nineteenth valve LV19 and a diaphragm pump P1 after detection.

Further, referring to fig. 2, fig. 3, fig. 4 and fig. 6, the fluid path system further includes: the device comprises a to-be-tested sample collecting needle cleaning device C2, a stirring rod cleaning device C3, an eleventh valve LV11 and a twelfth valve LV12, wherein the eleventh valve LV11 is respectively communicated with a third interface 173 of the seventeenth valve and a liquid inlet C21 of the to-be-tested sample collecting needle cleaning device; a liquid inlet C31 of the stirring rod cleaning device is communicated 053 with a third interface of the fifth valve; one interface of the twelfth valve LV12 is simultaneously communicated with the liquid outlet C22 of the to-be-tested sample collection needle cleaning device and the liquid outlet C32 of the stirring rod cleaning device, and the other interface of the twelfth valve LV12 is communicated with the waste liquid storage tank 700.

In this embodiment, the first port 171 of the seventeenth valve is communicated with the third port 173 of the seventeenth valve, and the piston of the sixth injector ZS6 injects the sheath fluid contained in the sixth injector ZS6 into the sample collection needle cleaning device C2 through the fluid inlet C21 of the sample collection needle cleaning device to be tested under thrust, and cleans the first device contained in the sample collection needle cleaning device C2 to be tested; the first port 031 of the third injection valve is communicated with the second port 32 of the third valve, the first port 041 of the fourth valve is communicated with the third port 043 of the fourth valve, the first port 051 of the fifth valve is communicated with the third port 053 of the fifth valve, and the piston of the second injector ZS2 injects the cleaning liquid contained in the second injector ZS2 into the stirring rod cleaning device C3 through the liquid inlet C31 of the stirring rod cleaning device under the action of thrust, and cleans the second device contained in the stirring rod cleaning device C3. And the cleaned liquid flows out from the liquid outlet C22 of the to-be-detected sample collecting needle cleaning device and the liquid outlet C32 of the stirring rod cleaning device, and the liquid are collected and injected into the waste liquid collecting tank 700 through the twelfth valve LV12 and the diaphragm pump P1. In this embodiment, the liquid discharge port C22 of the to-be-measured sample collection needle cleaning device and the liquid discharge port C32 of the stirring rod cleaning device discharge the collected waste liquid, so that the pipeline structure for discharging the waste liquid can be simplified, the number of pipelines in the liquid path 400 can be reduced, the structure of the device can be further simplified, and the cost of the device can be reduced.

In the present embodiment, the components of the sheath liquid and the cleaning liquid 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 sample collecting needle Z5 to be tested, the second device is a stirring rod for stirring the mixture in the reaction cup during the incubation process, and the sample collecting needle Z5 to be tested and the stirring rod are mounted on the same mounting plate and driven by the same driving mechanism. Meanwhile, the distance between the to-be-tested sample collecting needle cleaning device C2 and the stirring rod cleaning device C3 is matched with the distance between the to-be-tested sample collecting needle Z5 and the stirring rod. In addition, the sample collection needle cleaning device C2 that awaits measuring with puddler cleaning device C3 is along actuating mechanism symmetry sets up, can make the structure of device is compacter, is favorable to the miniaturization of device.

In order to solve the technical problems, the invention adopts a technical scheme that: a sample analyzer is provided. Referring to fig. 7, fig. 7 is a schematic structural diagram of a sample analyzer according to an embodiment of the present invention, and the sample analyzer 1 includes any one of the liquid path system 10, the optical detection device 20, and the control circuit 30. In this embodiment, the optical detection device 20 includes a laser emitting device (not shown) that emits laser light to the sheath fluid-entrained sample to be detected at the top opening 422 of the sheath fluid flow tube 420, and a light beam collecting device (not shown) that collects intensities of scattered light and fluorescence emitted by the sample to be detected under the irradiation of the laser light, so as to further determine the classification and quantity of the sample to be detected.

In order to solve the above problems, the present invention adopts a technical solution that: a method of sample analysis is provided.

Referring to fig. 8, fig. 8 is a schematic flow chart of a sample analysis method according to an embodiment of the present invention, the method including steps;

s100, providing an analysis device, wherein a liquid path system of the device comprises a reagent collecting liquid path, an original sample collecting liquid path, a sample collecting liquid path to be detected and a separation liquid path.

And S200, sucking a reagent by the reagent collecting liquid path and then discharging the reagent to a reaction cup.

In the step S200, the reagent includes at least one of a magnetic bead, an antibody, and a bio-fluorescein. At the first reagent addition, magnetic beads were added. The adding sequence of the rest reagents can be adjusted according to the actual operation process, and is not limited here.

S300, sucking an original sample by the original sample collecting liquid path, and then discharging the original sample into the reaction cup containing the reagent.

In step S300, the original sample may be a blood sample or other samples, and further, the blood sample may be a whole blood sample or a serum sample for providing antigens.

S400, performing at least one pretreatment operation, wherein the pretreatment operation comprises separation treatment, and the separation liquid path sucks the separated liquid after the separation treatment.

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 sucking the separated liquid after the separation process through the separation liquid path.

And S500, repeating the reagent adding, the pretreatment operation and the separation operation to obtain a sample to be detected.

In the step S500, the steps S200 and S400 are repeated, that is, the step S400 is required to be performed after each reagent is added until the sample to be tested is prepared. In this embodiment, the sample to be detected is a sandwich structure of magnetic bead-antigen-antibody-fluorescein.

S600, the sample collecting liquid path to be detected absorbs a sample to be detected to the sample collecting liquid path to be detected, and an optical detection device is used for detecting the sample to be detected.

In step S600, the sample analysis performed on the sample to be tested may be an immunoassay, in particular, a chemo-fluorescence immunoassay performed using a flow device.

The above description is only an embodiment of the present invention, and not intended to limit the scope of the present invention, and all modifications of equivalent structures and equivalent processes performed by the present specification and drawings, or directly or indirectly applied to other related technical fields, are included in the scope of the present invention.

Claims

1. A fluid path system of a sample analysis device, the fluid path system comprising:

2. The fluid path system of claim 1, wherein the sample collection fluid path to be tested is in communication with a waste fluid recovery tank and a sheath fluid storage tank, respectively, the reagent collection fluid path is in communication with the waste fluid recovery tank and a cleaning fluid storage tank, respectively, the original sample collection fluid path is in communication with the waste fluid recovery tank and the sheath fluid storage tank, respectively, and the separation fluid path is in communication with the waste fluid recovery tank and the cleaning fluid storage tank.

3. The fluid path system of claim 2, wherein the reagent collection fluid path comprises: a reagent collecting needle, a first injector, a second injector, a first valve, a second valve, a third valve and a fourth valve,

a first interface of the first valve is communicated with an injection port of the first injector, and a second interface of the first valve is respectively communicated with the cleaning liquid storage tank and a second interface of the fourth valve; the third interface of the first valve is communicated with the reagent collecting needle;

the second valve is respectively communicated with the side wall opening of the first injector and the third port of the third valve;

the first port and the second port of the third valve are respectively communicated with the first ports of the second injector and the fourth valve;

the injection port of the first injector is an opening arranged opposite to the piston of the first injector, and the first interfaces of the first valve, the third valve and the fourth valve are selectively communicated with the second interfaces and the third interfaces respectively.

4. The fluid path system of claim 3, wherein the reagent collection fluid path further comprises a reagent collection needle cleaning device and a fifth valve, wherein a first port of the fifth valve is in communication with a third port of the fourth valve, a second port of the fifth valve is in communication with an inlet of the reagent collection needle cleaning device, and an outlet of the reagent collection needle cleaning device is in communication with the waste fluid storage tank;

the first port of the fifth valve is selectively communicated with the second port of the fifth valve and the third port of the fifth valve.

5. The fluid path system of claim 4, wherein the raw sample collection fluid path comprises: an original sample collecting needle, a third injector, a fourth injector, a sixth valve, a seventh valve and an eighth valve,

the first port of the seventh valve is communicated with the injection port of the third injector, and the third port of the seventh valve is communicated with the original sample collecting needle;

a first interface of the eighth valve is communicated with the fourth injector, and a second interface of the eighth valve is communicated with the cleaning solution storage tank;

the sixth valve is respectively communicated with the side wall opening of the third injector and the third interface of the eighth valve;

the injection port of the third injector is an opening arranged opposite to the piston of the third injector, and the respective first ports of the seventh valve and the eighth valve are selectively communicated with the respective second ports and the respective third ports.

6. The fluid path system of claim 5, wherein the volume of the first syringe is less than the volume of the second syringe; the volume of the third syringe is less than the volume of the fourth syringe.

7. The fluid path system of claim 6, wherein the primary sample collection fluid path further comprises a primary sample collection needle cleaning mechanism disposed around the primary sample collection needle, and the first and second interfaces of the primary sample collection needle cleaning mechanism are respectively in communication with the second interface of the seventh valve and the waste fluid storage tank.

8. The fluid path system of claim 7, wherein the separation fluid path comprises: a plunger pump, a cleaning needle, a liquid discharge needle, a diaphragm pump, a ninth valve and a tenth valve, wherein the liquid discharge needle comprises a long needle and a short needle which are arranged in rows,

a first port of the ninth valve is communicated with the plunger pump, and a second port and a third port of the ninth valve are respectively communicated with the cleaning liquid storage tank and the first port of the tenth valve;

the second port and the third port of the tenth valve are respectively communicated with the cleaning needle and the short needle;

the diaphragm pump is respectively communicated with the waste liquid storage tank and the long needle;

wherein the first ports of the ninth valve and the tenth valve are selectively communicated with the second ports and the third ports respectively.

9. The fluid path system according to claim 8, wherein the separation fluid path further comprises an isolation chamber provided on a pipeline between the diaphragm pump and the long needle and communicating with the diaphragm pump and the long needle, respectively.

10. The fluid path system of claim 9, wherein the sample collection fluid path comprises: a sample collecting needle to be tested, a fifth injector, a sixth injector, a flow chamber, a thirteenth valve, a fourteenth valve, a fifteenth valve, a sixteenth valve and a seventeenth valve,

a sample flowing pipe to be measured of the flowing chamber is respectively communicated with the thirteenth valve and the fifteenth valve, an opening on the side wall of a sheath fluid circulating pipe sleeved on the periphery of the sample flowing pipe to be measured is communicated with the fourteenth valve, and an opening on the top of the sheath fluid circulating pipe is communicated with the waste liquid storage tank;

the thirteenth valve is also communicated with the sample collecting needle to be detected;

the fourteenth valve is also communicated with a third port of the seventeenth valve;

the fifteenth valve is also communicated with an injection port of the fifth injector;

the sixteenth valve is respectively communicated with the side wall opening of the fifth injector and the third interface of the seventeenth valve;

a first port of the seventeenth valve is communicated with the sixth injector, and a second port of the seventeenth valve is communicated with the sheath fluid storage tank;

the injection port of the fifth injector is an opening arranged opposite to the piston of the fifth injector, and the first port of the seventeenth valve is selectively communicated with the second port of the seventeenth valve and the third port of the seventeenth valve.

11. The fluid path system of claim 10, further comprising: a sample collecting needle cleaning device to be tested, a stirring rod cleaning device, an eleventh valve and a twelfth valve,

the eleventh valve is respectively communicated with the third interface of the seventeenth valve and the liquid inlet of the cleaning device for the sample collecting needle to be detected;

a liquid inlet of the stirring rod cleaning device is communicated with a third interface of the fifth valve;

and one interface of the twelfth valve is simultaneously communicated with the sample collecting needle cleaning device to be detected and the liquid outlet of the stirring rod cleaning device, and the other interface of the twelfth valve is communicated with the waste liquid storage tank.

12. A sample analysis device comprising a fluid path system according to any one of claims 1 to 10, an optical detection device and a control circuit.

13. A method of sample analysis, the method comprising: