WO2020155387A1 - 液体分配装置和免疫分析仪 - Google Patents

液体分配装置和免疫分析仪 Download PDF

Info

Publication number
WO2020155387A1
WO2020155387A1 PCT/CN2019/082173 CN2019082173W WO2020155387A1 WO 2020155387 A1 WO2020155387 A1 WO 2020155387A1 CN 2019082173 W CN2019082173 W CN 2019082173W WO 2020155387 A1 WO2020155387 A1 WO 2020155387A1
Authority
WO
WIPO (PCT)
Prior art keywords
sample
reactor
unit
station
buffer
Prior art date
Application number
PCT/CN2019/082173
Other languages
English (en)
French (fr)
Inventor
张震
Original Assignee
深圳迎凯生物科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 深圳迎凯生物科技有限公司 filed Critical 深圳迎凯生物科技有限公司
Publication of WO2020155387A1 publication Critical patent/WO2020155387A1/zh

Links

Images

Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/5302Apparatus specially adapted for immunological test procedures
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/531Production of immunochemical test materials
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54313Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals the carrier being characterised by its particulate form
    • G01N33/54326Magnetic particles
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584Control arrangements for automatic analysers
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations

Definitions

  • This application relates to the technical field of in vitro diagnostics, and in particular to a liquid distribution device and an immunoassay analyzer containing the liquid distribution device.
  • the automatic immunoassay analyzer can quantitatively or qualitatively detect the target analytes such as antibodies and antigens contained in the blood samples waiting to be tested.
  • the test samples and reagents or reactants
  • the signal reagent is distributed in the reactor to measure the optical signal or electrical signal, so as to realize the target analysis substance contained in the sample to be tested. Measurement analysis.
  • test flux can be understood as the number of test results that the immunoassay analyzer can report in a unit of time, that is, the number of reactors that contain the target analyte. The greater the total number of reactors measured in a time, the higher the test throughput of the immune analyzer. Because the reaction mode and test process of the analysis project are usually different, the test throughput of the immune analyzer is not static. The maximum test throughput is usually used as a measure of the speed of the immune analyzer. This application is for convenience of description, unless otherwise specified, the test Throughput refers specifically to the maximum test throughput of the analyzer. Consider the processing of the reactor by the immune analyzer as a pipeline.
  • N reactors containing the target analyte in a unit of time to complete the measurement and leave the pipeline in order to ensure that the test is continuously and reliably performed at the maximum throughput, it must be performed at the same time
  • N empty reactors entering the pipeline that is, the flow rate of the reactor at the inlet of the pipeline (inlet flow rate) is equal to the flow rate at the outlet (outlet flow rate).
  • the flow of each link in the middle of the pipeline of the reactor should be equal to the inlet flow and the outlet flow, that is, the flow rates in all parts of the pipeline are equal.
  • a technical problem solved by this application is how to improve the working efficiency of the liquid distribution device.
  • a liquid distribution device includes:
  • a buffer unit capable of receiving and driving the reactor to move, and the reactor on the buffer unit is used to distribute samples
  • the ferry unit is arranged close to the buffer unit.
  • the ferry unit can drive the reactor that inputs the allocated sample from the buffer unit to move linearly.
  • the reactor on the ferry unit with the allocated sample is used to distribute reagents, so The ferry unit mixes the reactants in the reactor after the reagents are distributed;
  • the sample can be simultaneously distributed to the empty reactor on the buffer unit.
  • An immunoassay analyzer includes the above-mentioned liquid distribution device.
  • Fig. 1 is a schematic diagram of a plane structure of a first example immune analyzer provided by the first embodiment.
  • Fig. 2 is a partial three-dimensional structure diagram of the ferry unit in Fig. 1.
  • Fig. 3 is a schematic plan view of a second example immune analyzer provided by the first embodiment.
  • Fig. 4 is a schematic plan view of a third example immune analyzer provided by the first embodiment.
  • Fig. 5 is a schematic diagram of the planar structure of the immune analyzer provided in the second embodiment.
  • Figure 6 is a schematic diagram of continuously distributing the same sample to at least two reactors.
  • Figure 7 is a timing diagram of the distribution of samples and reagents to the reactor.
  • Figure 8 is a schematic diagram of providing diluted samples to at least two reactors.
  • Figure 9 is a flow chart of the first liquid dispensing method.
  • Figure 10 is a flow diagram of the second liquid dispensing method.
  • Figure 11 is a flow chart of the sample dilution method.
  • Figure 12 is a flow chart of the third liquid dispensing method.
  • Figure 13 is a timing diagram of the third liquid dispensing method for dispensing samples and reagents to the reactor.
  • the incubation of the sample and reagent specifically refers to the antigen-antibody binding reaction or biotin avidin binding of the reactants in the reactor 20 before the start of cleaning and separation.
  • the reaction process The reagents and analysis items described here have a "one-to-one correspondence" relationship, that is, the specific reagents corresponding to different analysis items are generally different in terms of formula, reagent quantity, component quantity, etc.
  • reagents usually include multiple components, such as common 2-5 components, including magnetic particles, markers, diluents, dissociating agents, and other reagent components (the corresponding reagent components can be separated Represented by R1, R2, R3, R4).
  • T4 reagent thyroxine
  • R1 magnetic particles
  • R2 labeling
  • R4 reagent dissociating agent
  • multiple reagent components of an analysis item can be distributed at one time or in multiple steps. When distributed in steps, it is defined as first reagent, second reagent, third reagent, etc. according to the order of distribution. After the incubation is completed, cleaning and separation are carried out.
  • Cleaning and separation refers to the use of a magnetic field to capture the bound magnetic particles and labeled complexes, while removing free (free) markers and other unreacted or bound components (this text is convenient for expression, referred to as Unbound components) process.
  • the signal reagent is distributed, the signal is incubated (generally 1-6 minutes), and finally the amount of luminescence produced by the reaction between the labeling reagent and the signal reagent is measured (this text is convenient for expression, called reactant signal).
  • the signal reagent is used to measure the signal (usually the amount of luminescence), usually a kind of general reagent, and the corresponding relationship with the analysis item is "one-to-many", that is, different analysis items share the signal reagent.
  • Signal incubation refers to a process in which the cleaned and separated reactor 20 is reacted for a period of time in a constant temperature environment after the signal reagent is distributed to increase the signal. It should be pointed out that due to the difference in the specific components of the signal reagent, some luminescence systems do not require signal incubation, and can be directly measured during or after the signal reagent is distributed.
  • the signal reagent can be one or more, for example, some signal reagents include a first signal reagent, a second signal reagent, and so on.
  • the immune analyzer 10 can perform analysis corresponding to several different analysis items on the sample.
  • Work cycle or cycle is the shortest time window that can be reproduced cyclically during the test. It usually has a fixed length of time. Within the cycle time, a certain number of process operations, tasks or work packages, such as liquid withdrawal Operations and tasks such as mixing, incubating, washing and separating, and measuring are performed serially or in parallel in a controlled sequence. The tasks of the same component in a cycle are usually executed in series, and the tasks of different components in the same cycle depend on whether there is a dependency between the actions of related components and can be executed serially or in parallel. All process operations performed in one cycle are executed only when needed, and not necessarily repeated in another cycle. In particular, certain process operations may be repeated in every cycle, while others may occur every two or more cycles.
  • each test is usually at a different stage of the test process.
  • process operations that occur in a single cycle only certain process operations are dedicated to executing a test, and other process operations are used for Perform other tests.
  • the time length of multiple parallel cycles has a multiple relationship, and the multiple is usually equal to the number of the same component.
  • each ferry unit 200 works in the first cycle.
  • the cycle length is N times the second cycle, and the action sequences of the N ferry units 200 are continuously "staggered in parallel" for the second cycle.
  • the immune analyzer 10 provided by an embodiment of the present application includes a liquid distribution device 11 and a reaction device 12.
  • the liquid distribution device 11 is located beside the reaction device 12, and the liquid distribution device 11 is used in the reactor 20. Complete the distribution of samples and reagents, and the mixing of samples and reagents.
  • the reaction device 12 is used for incubating, cleaning, separating, and measuring the sample and reagent (reactant) after mixing in the reactor 20.
  • the liquid distribution device 11 includes a buffer unit 100, a supply silo 130, a supply slide 140, a ferry unit 200, a sample addition part 300, a sample delivery unit 400, a reagent distribution part 500, a storage unit 600, a transfer unit 700, a cleaning tank 800 and Sorting agency.
  • the liquid distribution device 11 may also include a sample adding drive unit 301, a reagent drive unit 501, and a sample adding power unit and a reagent distribution drive.
  • the sample adding piece 300 is installed on the sample adding drive unit 301, and the sample adding drive unit 301 is used for The sample adding member 300 is driven to move so that the sample adding member 300 can absorb or remove the sample under the action of the sample adding power device.
  • the reagent distributing member 500 is installed on the reagent driving unit 501, and the reagent driving unit 501 is used to drive the reagent distributing member 500 to move so that the reagent distributing member 500 sucks or discharges the reagent under the reagent distributing power unit.
  • the sample loading power unit and the reagent distribution power unit can use general fluid quantitative devices such as syringes, plunger pumps, and quantitative pumps.
  • the sample conveying unit 400 may include a sample rack 410, a sample tube 430, and a conveying rail 420.
  • the sample rack 410 may be matched with the conveying rail 420.
  • the sample tube 430 is placed on the sample rack 410.
  • the sample tube 430 is used to hold samples. Five to ten sample tubes 430 can be placed on one sample rack 410.
  • the sample rack 410 drives the sample tube 430 to move to a designated position along the conveying track 420, the sample adding component 300 aspirates a sample of the tube 430 and distributes the sample to the empty reactor 20.
  • the supply silo 130 is used to store clean and empty reactors 20, and the sorting mechanism can be used to sort the scattered reactors 20 from the supply silo 130 to arrange them in a certain order, and the supply chute 140 will sort the reactions.
  • the reactors 20 are introduced into the buffer unit 100 one by one, and the buffer unit 100 is used to buffer the reactor 20 conveyed by the supply chute 140.
  • the entire liquid distribution device 11 has a receiving station 33, a sample adding station 34 and a removing station 35.
  • the buffer unit 100 includes a turntable 110, which can rotate around its own central axis. A plurality of buffer positions 101 are provided on the turntable 110. The buffer positions 101 are used to carry the reactor 20.
  • the buffer positions 101 can be accommodating holes. The accommodating hole can also be replaced by a solid structure such as a bracket, as long as the reactor 20 can be placed on the turntable 110.
  • the buffer positions 101 are distributed along the circumferential interval of the turntable 110.
  • the buffer positions 101 can be driven to move between the receiving station 33, the sample loading station 34 and the removal station 35, so that the reaction on the turntable 110
  • the device 20 moves between the receiving station 33, the sample loading station 34, and the removing station 35.
  • the turntable 110 drives the reactor 20 to make a circular movement between the receiving station 33, the sample loading station 34, and the removing station 35.
  • the reactor 20 from the supply chute 140 will enter the buffer position 101 on the turntable 110 at the receiving station 33.
  • the sample 300 can aspirate the sample from the sample tube 430 to distribute it to the reactor 20.
  • the transfer unit 700 will have the sample The reactor 20 is separated from the turntable 110 at the removal station 35 and transferred to the ferry unit 200.
  • the buffer bits 101 are arranged at intervals along the circumference of the turntable 110, and the buffer units 100 may only be arranged to form a buffer circle, which is arranged close to the edge of the turntable 110.
  • the cache bits 101 can also be arranged to form multiple cache circles, and the multiple cache circles are arranged concentrically around the center axis of the turntable 110.
  • the cache unit 100 includes a slider 120.
  • the slider 120 is also provided with a cache position 101 for placing the reactor 20, and the cache position 101 on the slider 120 may also be a receiving hole.
  • the cache bits 101 may only be distributed along a straight line on the slider 120 to form a row.
  • the cache bits 101 may be distributed on the slider 120 along a straight line to form multiple rows.
  • the multiple rows of cache bits 101 are arranged on the slider 120 in a matrix distribution.
  • the sliding block 120 moves linearly between the receiving station 33, the sample loading station 34 and the removal station 35, thereby driving the buffer position 101 (corresponding to the reactor 20) on it in the receiving station 33, sample loading station 34 and Move out of the station 35 to move.
  • the reactor 20 enters the sliding block 120 at the receiving station 33, the sample addition member 300 distributes the sample to the reactor 20 located at the sample addition station 34, and the transfer unit 700 will be filled
  • the reactor 20 with the sample is separated from the slider 120 at the removal station 35 and transferred to the ferry unit 200.
  • the slider 120 and the buffer position 101 on it linearly reciprocate between the receiving station 33, the sample adding station 34, and the removing station 35 to complete the receiving, sample distribution, and full storage of the reactor 20
  • the slider 120 itself can be designed to be smaller in volume.
  • the area covered by the linear motion track of the slider 120 is smaller, which is beneficial to the supply bin 130, the supply slide 140, and the sample.
  • the optimized spatial layout of the conveying unit 400, the sample addition part 300, the transfer unit 700, etc. can make the liquid distribution device 11 more compact and lower in cost.
  • the cache unit 100 includes both a turntable 110 and a slider 120 each provided with a cache bit 101.
  • the turntable 110 rotates around its own central axis, and the turntable 110 can drive the cache bit 101 on it to pass
  • the receiving station 33 and the reactor 20 on the supply chute 140 will enter the buffering position 101 on the turntable 110 at the receiving station 33.
  • the slider 120 moves linearly between the sample loading station 34 and the removal station 35.
  • the transfer unit 700 can separate the empty reactor 20 from the turntable. 110 and transferred to the sliding block 120 at the removal station 35.
  • the sample loading part 300 distributes the sample to the empty reactor 20, and then the sliding block 120 After driving the reactor 20 containing the sample to the removal station 35, the transfer unit 700 separates the reactor 20 containing the sample from the removal station 35 from the slider 120 and transfers it to the ferry unit 200.
  • the liquid distribution device 11 further includes a frame 210, a conveyor 220, a support 230, and a driver 240.
  • the conveyor 220 is arranged on the frame 210, and the conveyor 220 is used to drive the support 230.
  • the conveyor 220 includes a motor 221, a driving wheel 222, a driven wheel 223, and a timing belt 224.
  • the motor 221 is used to drive the driving wheel 222 to rotate.
  • the timing belt 224 is wound around the driving wheel 222 and the driven wheel 223.
  • the transmitter 220 can also be replaced by one or more of transmission mechanisms such as a screw mechanism and a rack and pinion.
  • the rack 210 may be provided with a sliding rail 225, the support 230 is matched with the sliding rail 225, the timing belt 224 is connected with the support 230 and drives the support 230 to slide along the extending direction of the sliding rail 225, the driver 240 and the ferry unit 200
  • the ferry unit 200 is used to place the reactor 20, and the driver 240 can drive the ferry unit 200 to produce eccentric oscillations, so that the samples and reagents (reactants) in the reactor 20 produce non-contact eccentric oscillations. And to achieve mixing.
  • the ferry unit 200 may be provided with a plurality of receiving holes, and the reactor 20 is inserted into the receiving holes, so as to realize the bearing function of the ferry unit 200 to the reactor 20.
  • the receiving hole can also be replaced by a solid structure such as a bracket, as long as the reactor 20 can be placed on the ferry unit 200.
  • the entire liquid distribution device 11 also has an initial station 30 and a first station 31.
  • the ferry unit 200 can reciprocate between the initial station 30 and the first station 31. Linear motion.
  • the transfer unit 700 can transfer the reactor 20 containing samples from the buffer unit 100 to the ferry unit 200 at the initial station 30.
  • the ferry unit 200 drives the reactor 20 containing the sample to move to the first station 31, and the reagent distribution member 500 will suck reagents from the storage unit 600 for storing reagents and distribute the reagents to the first station. 31 of the reactor 20.
  • the driver 240 can drive the ferry unit 200 to eccentrically oscillate, thereby mixing the samples and reagents in the reactor 20, so that the mixing of reactants and the movement of the ferry unit 200 can be achieved.
  • the ferry unit 200 can simultaneously mix the reactants in the reactor 20 during the movement process, which improves the mixing efficiency and mixing effect, thereby increasing the test throughput of the whole machine.
  • the driver 240 can also drive the ferry unit 200 to eccentrically oscillate to mix the samples and reagents in the reactor 20 uniformly.
  • the ferry unit 200 returns the reactor 20 after reagent distribution to the initial station 30.
  • the transfer unit 700 can separate the reactor 20 with the reactants from the initial station 30 from the ferry unit 200 and transfer it to the reaction device 12 for reaction.
  • the reactor 20 performs incubation, washing and separation, and measurement processing on the reaction device 12.
  • the driver 240 directly oscillates the ferry unit 200 eccentrically, so that the reactants in the reactor 200 on the ferry unit 200 can be mixed uniformly. No additional independent mixing device is needed.
  • the ferry unit 200 is linearly moved or stationary. The mixing of the reactants in the reactor 200 is not restricted, and the problems of the complicated mixing device, low mixing efficiency and poor mixing effect of the prior art are solved.
  • the apron unit 200 performs linear motion between the sample loading part 300, the transfer unit 700, and the reagent distribution part 500. On the one hand, the control difficulty of linear motion is reduced, which makes the apron unit 200 move more accurately and efficiently, and prevents the apron unit 200 from deviating from the designated stop.
  • the reagent distributor 500 reliably adds the reagents to the reactor 20 at the first station 31; on the other hand, the reactor 20 containing the sample is carried on the buffer unit 100 to be transferred to the ferry unit 200 to add reagents and mix. It is not necessary to transfer all the reactors 20 containing samples to the ferry unit 200. This makes full use of the carrying space of the buffer unit 100, so that the number of reactors 20 carried by the ferry unit 200 at the same time is reduced, ensuring the ferry unit
  • the volume of 200 is designed to be smaller and the structure is more compact.
  • the area covered by the linear motion track of the ferry unit 200 is smaller, which solves the problem that the sample addition piece 300, the transfer unit 700, and the reagent distribution piece 500 in the prior art must be along
  • the large-radius rotation or the restriction of the rotary disk layout optimizes the spatial layout and control process between components or units, and can more efficiently connect and coordinate the logical actions among the sample addition unit 300, the transfer unit 700, and the reagent distribution unit 500.
  • the immune analyzer can be made more compact and the overall work efficiency can be improved.
  • the reactor 20 By using the reactor 20 on the buffer unit 100 for sample distribution, the reactor 20 after the sample distribution is transferred to the ferry unit 200 for reagent distribution and mixing, so that the sample distribution and the reagent distribution are in different independent units.
  • the realization and mixing are directly realized on the ferry unit, which solves the mutual limitation of the distribution of samples and reagents in the prior art and the problem of mixing the reactants individually at a specific station, and improves the efficiency of liquid distribution and mixing .
  • the storage unit 600 is a rotatable disk, and the storage unit 600 is arranged close to the first station 31.
  • a plurality of storage parts 610 are provided on the storage unit 600.
  • the storage part 610 is used to place and store reagent containers. It is placed in a reagent container, and the reagent distributing member 500 is used for sucking the reagent components in the reagent container on the storage part 610 and distributing the reagent components into the reactor 20 at the first station 31.
  • the number of storage units 610 can be set according to needs.
  • the number of storage units 610 on each storage unit 600 is preferably 15-50, for example, the storage units on each storage unit 600 The number of 610 is 25, so that two storage units 600 can store 50 reagent containers online at the same time.
  • Each storage unit 600 stores all the reagent components required by the corresponding analysis project. For example, in an analysis project, three reagent components including magnetic particles, label and dissociating agent must be allocated to the reactor 20, then the magnetic particles The three components, the label and the dissociating agent, are stored in the same storage unit 600. When a certain analysis project needs to load multiple reagent containers to expand the test volume of the project, the multiple reagent containers can be stored in each storage unit 600 in any suitable combination.
  • TSH thyroid stimulating hormone
  • all three TSH reagent containers can be loaded in the same storage unit 600. It is also possible to load one TSH reagent container in one storage unit 600 and the other two in the other storage unit 600.
  • the storage unit 610 can be driven to move to the designated liquid suction station, so that the reagent distribution member 500 can suck the reagent on the storage unit 610 at the liquid suction station and distribute it to the reactor 20.
  • At least one cavity of the reagent container on the storage unit 610 (for example, a magnetic particle cavity containing magnetic particle reagent components) is rotated around its own central axis , So that the magnetic particle reagent component in the form of a solid suspension generates a vortex, and prevents the solid matter (such as magnetic particles) from being precipitated.
  • a scanner can also be provided on the storage unit 600, and the scanner can identify the barcode information of the reagent container on the storage part 610, so as to distinguish different reagents.
  • a refrigerator may also be provided on the storage unit 600, and the refrigerator may perform refrigeration processing on the reagents in the storage part 610, so as to realize online long-term storage of the reagents.
  • the transfer unit 700 is used to transfer the reactor 20 between the ferry unit 200, the buffer unit 100 and the reaction device 12.
  • the transfer unit 700 can move horizontally and vertically. Obviously, the removal station 35 and the initial station 30 are both in transfer Above the movement trajectory of the unit 700.
  • the liquid distribution device 11 When the liquid distribution device 11 is used to distribute samples and reagents in the reactor 20 and mix the samples and reagents, a first liquid distribution method can be formed.
  • the main characteristics of the first liquid distribution method are: Distributed from the buffer unit 100 (not from the ferry unit 200) to the reactor 20.
  • the first liquid distribution method mainly includes the following steps:
  • S520 Stop the ferry unit 200 at the initial station 30, and transfer the reactor 20 to which the sample has been allocated from the buffer unit 100 to the ferry unit 200 at the initial station 30;
  • the ferry unit 200 is moved between the initial station 30 and the first station 31, and the reagent is distributed to the reactor 20 located at the first station 31; of course, the ferry unit 200 can be moved between the initial station 30 and the first station 31. Perform linear movement between the first stations 31. Wherein, when the reactor 20 carrying the distributed sample in the ferry unit 200 is moving or stationary, the sample can be distributed to the empty reactor 20 on the buffer unit 100 at the same time.
  • the ferry unit 200 is allowed to mix the sample and the reagents.
  • the ferry unit 200 can mix the reactants in the reactor 20 in a non-contact eccentric oscillating manner, thereby eliminating the carryover pollution of the reactants caused by other contact stirring.
  • the ferry unit 200 can mix the samples and reagents in the reactor 20.
  • the shortest time window in which the action sequence in the above steps S520, S530, S540, and S550 executed by the ferry unit 200 can be reproduced is recorded as the working period T, so that the ferry unit 200 works in one
  • Reactor 20 exits at position 30.
  • t ⁇ T more than one sample is distributed to the reactor 20 located on the buffer unit 100 in the interval of the working period T.
  • There is at least one t so that when t ⁇ T, the time for allocating samples to the empty reactor 20 on the cache unit 100 is not fixed, and it is not limited by the working period T.
  • the interval for allocating samples is determined according to the needs of the test, so that Testing is more flexible and efficient.
  • the sample is only distributed from the buffer unit 100 to the reactor 20, and not from the ferry unit 200 to the reactor 20, so that the distribution of samples from the ferry unit 200 to the reactor 20 can be omitted. Time, improve the working efficiency of the liquid distribution device.
  • the buffer unit 100 only includes the rotary disk 110 that moves in a circular motion or only the slider 120 that moves in a linear motion
  • the step of allocating samples to the buffer unit 100 includes the following sub-steps:
  • the reactor 20 follows the buffer unit 100 to move from the sample loading station 34 to the removal station 35, and the reactor 20 can be transferred from the removal station 35 to the ferry unit 200.
  • the step of distributing samples to the buffer unit 100 includes the following sub-steps:
  • the reactor 20 is transferred from the turntable 110 to the sliding block 120 of the buffer unit 100.
  • the reactor 20 follows the sliding block 120 to move linearly to the sample loading station 34, and distributes the sample to the reactor 20 located at the sample loading station 34 ;and
  • the reactor 20 follows the sliding block 120 to move linearly from the sample loading station 34 to the removal station 35, and the reactor 20 can be transferred from the removal station 35 to the ferry unit 200.
  • a reactor 20 whose reactants have been homogenized must be removed from the ferry unit 200 within a prescribed time. Therefore, when a single reactor 20 enters the ferry unit 200 until it leaves the ferry unit 200, the shorter the time (that is, the total residence time of the single reactor 20 on the ferry unit 200), the greater the test flux.
  • the residence time of the reactor 20 on the ferry unit 200 It will include at least sample distribution time, reagent distribution time, movement time of the ferry unit 200, and reactant mixing time.
  • the sample is only distributed from the buffer unit 100 to the reactor 20 (the sample is not distributed from the ferry unit 200 to the reactor 20), that is, the sample is only distributed in the reactor 20 of the buffer unit 100;
  • the reactor 20 containing the sample is transferred from the buffer unit 100 to the ferry unit 200, the reagent will be distributed to the reactor 20 on the ferry unit 200 that has already contained the sample. Therefore, compared with the traditional solution, on the basis of the same working efficiency of the sample addition piece 300 and the reagent distribution piece 500 and the same operating speed of the ferry unit 200, the residence time of the reactor 20 on the ferry unit 200 only includes reagent distribution.
  • the reactor 20 stays on the ferry unit 200 for a short time, so that the reactor 20 can remove the reactants in a relatively short time. Mixing and leaving the ferry unit 200 improves the test throughput of the entire immune analyzer 10.
  • the distribution of samples will not be restricted by the movement speed and position of the ferry unit 200.
  • the sample addition part 300 can make full use of the idle waiting time, thereby pre-allocating the samples from the buffer unit 100 to the reactor 20, compressing the total residence time of a single reactor 20 on the ferry unit 200, and finally improving the maximum test The purpose of flux. Therefore, even when the reagent distribution piece 500 distributes the reagents from the ferry unit 200 to the reactor 20 thereon, the sample addition piece 300 can distribute samples from the buffer unit 100 to the reactor 20 thereon, that is, samples and reagents. The allocation can be performed synchronously, thereby eliminating the sample allocation time on the ferry unit 200.
  • the sample distribution cannot get rid of the restriction of the speed and position of the ferry unit 200. Only when the ferry unit 200 reaches the initial station 30, the sample 300 can be distributed from the swing unit to the reactor 20. For samples, it is impossible to distribute samples and reagents to the reactor 20 at the same time.
  • the operating speed (work efficiency or workload) of the ferry unit 200, the sample addition piece 300, and the reagent distribution piece 500 can be appropriately reduced. ), so as to reduce the difficulty of controlling the movement of the ferry unit 200, the sample adding piece 300 and the reagent distribution piece 500, and also reduce the vibration, noise and failure of the components in the liquid distribution device 11 due to high-speed operation, and improve the entire liquid The running stability and reliability of the distribution device 11.
  • a second liquid distribution method can also be formed.
  • the main features of the second liquid distribution method are: The same sample is sucked through the sample addition member 300 and distributed multiple times to at least two reactors 20; at the same time, after the same sample is absorbed and continuously distributed to at least two reactors, the sample addition member 300 is cleaned or replaced. The sample is continuously distributed between at least two reactors, and the sample addition part 300 is not cleaned or replaced.
  • the second liquid distribution method mainly includes the following steps:
  • the sample addition part 300 is provided, and the buffer unit 100 and the ferry unit 200 are provided at the same time.
  • the same sample is sucked through the sample addition member 300 and continuously distributed to at least two reactors 20 of the buffer unit 100, and the time interval between the continuous distribution of samples to at least two reactors 20 vacant on the buffer unit 100 is recorded. Assign an interval t to the sample.
  • the same sample here specifically refers to the same sample to be tested (that is, a sample corresponding to a certain subject, such as a sample of a certain patient) that needs to be tested at least twice, and the at least two tests can be at least two Different analysis items can also be the same analysis items repeated at least twice; different samples refer to samples from different subjects.
  • sample addition member 300 After the same sample is drawn and continuously distributed to at least two reactors, the sample addition member 300 is cleaned or replaced. When the same sample is drawn and continuously distributed between at least two reactors, the sample addition part 300 is not cleaned or replaced. In particular, between distributing different samples, the sample addition member 300 is cleaned or replaced.
  • S740 Record the shortest time window that can be cyclically reproduced by the ferry unit 200 as the working period T, and make the ferry unit 200 move between the initial station 30 and the first station 31, and transfer the reagents through the reagent distributor 500.
  • the first station 31 is distributed to each reactor 20 that has contained samples. Specifically, the reagent is distributed at the first station 31 to each of the reactors 20 on the ferry unit 200 through the reagent distribution member 500. Sample in the reactor 20. Similar to the ferry unit 200, the reagent distributing member 500 also distributes the reagents according to the working period T, that is, in each working period T, the reagent is distributed to only one reactor 20 containing the sample. Therefore, for at least two reactors after the sample adding member 300 distributes samples according to the sample distribution interval t, the interval time between which the reagent is distributed by the same reagent distribution member 500 is at least T.
  • the ferry unit 200 is allowed to mix the sample and the reagent.
  • the ferry unit 200 can mix the reactants in the reactor 20 in a non-contact eccentric oscillating manner, thereby eliminating the carryover pollution of the reactants caused by other contact stirring.
  • the ferry unit 200 can mix the samples and reagents in the reactor 20.
  • the reactor 20 is removed from the ferry unit 200 from the initial station 30 by the transfer unit 700 and transferred to the reaction device 12.
  • the sample adding member 300 adopts an elongated cylindrical sample needle, and after the same sample is drawn and continuously distributed to at least two reactors, in particular, the sample needle is moved to
  • the cleaning tank 800 cleans the inner wall and the outer wall of the sample needle at the same time to remove carryover contamination between different samples.
  • the cleaning fluid is injected into the inner cavity of the sample needle through a fluid power device such as a syringe or a pump.
  • the cleaning fluid flowing through the inner cavity of the sample needle at a certain speed will wash the inner wall of the sample needle to achieve a cleaning effect.
  • the outer wall of the sample needle is sprayed or immersed in a cleaning liquid to clean it, and the cleaning liquid flowing from the inner cavity and the outer wall of the sample needle can be discharged into the cleaning tank 800 at the same time.
  • the cleaning time of the sample needle is 2 to 10 seconds.
  • the sample addition member 300 adopts a disposable suction nozzle. After the same sample is sucked and continuously distributed to at least two reactors 20, the disposable suction nozzle is replaced. In particular, between distributing different samples, Replace the disposable nozzle. In this way, the cleaning of the disposable nozzle can be omitted, and the cleaning time can be reduced to improve efficiency. At the same time, the cost of the disposable nozzle can be compensated by reducing the cost of cleaning liquid.
  • the sample addition member 300 when the sum of the samples required for all analysis items corresponding to the sample to be tested does not exceed the capacity of the sample needle, that is, when the capacity of the sample addition member 300 is greater than that of each reactor 20
  • the sample addition member 300 only sucks once and distributes the same sample to different reactors 20 in multiple consecutive times.
  • the sample addition piece 300 needs to draw the same blood sample (denoted as the first S) to detect two of the five items of A-function, namely the TSH item and the T4 item.
  • the reactor 20 For the reactor 20 that detects the TSH item, the reactor 20 (Denoted as TSH reactor) requires 100 microliters of blood sample; for the reactor 20 for testing T4 items, the reactor 20 (denoted as T4 reactor) requires 50 microliters of blood sample.
  • the volume of the sample addition piece 300 is greater than 150 microliters, that is, the volume of the sample addition piece 300 is greater than the sum of the blood sample volume required by the TSH reactor and the T4 reactor. Therefore, the sample addition piece 300 is disposable from the sample tube 430 Aspirate at least 150 microliters of blood sample (first S).
  • the buffer unit 100 drives the TSH reactor to move to the sample loading station 34, and the sample addition component 300 distributes 100 microliters of blood sample to the TSH reactor (first S) One S); then, the buffer unit 100 continues to drive the T4 reactor to the sample loading station 34, after the sample distribution interval t (there is at least one t such that t ⁇ T), the sample addition 300 distributes 50 to the T4 reactor Microliter blood sample (first S).
  • the sample addition member 300 can be moved above the cleaning tank 800 or in the cleaning tank 800 For backhaul calibration, you can also stay at sample loading station 34.
  • the reagent distributor 500 then distributes TSH reagents to the TSH reactor.
  • the TSH reagents may include R1 components and R2 components, and distribute T4 reagents to the T4 reactor after at least one working period T.
  • the T4 reagents may also include R1 components. Sub and R2 component.
  • the sample when the sum of the samples required for all analysis items corresponding to the sample to be tested exceeds the capacity of the sample needle, that is, when the capacity of the sample addition member 300 is less than the total amount of the same samples required by each reactor 20, the sample is added
  • the piece 300 draws the same sample (denoted as the second S) multiple times and distributes it to different reactors 20 according to the sample distribution interval t (there is at least one t such that t ⁇ T). For example, it is necessary to allocate the same sample (second S) to four reactors 20 to detect four different items.
  • the sample addition member 300 can be drawn twice to distribute the same sample to the four reactors 20 (second S). During operation, the sample addition part 300 sucks less than 500 microliters of sample for the first time (second S), and distributes it to the three reactors 20 according to the set amount for three consecutive times, and then, the sample addition part 300 second time Aspirate less than 500 microliters of sample and distribute it to the last reactor 20 in a set amount.
  • the sample adding piece 300 is moved into the cleaning tank 800 to reset the sample adding power unit. Since the reset needs to be carried out during the cleaning process of the sample addition piece 300, and there is no carryover problem between the same samples, only the sample addition piece 300 needs to be cleaned for a short period of time so that the sample addition piece 300 can be better completed. Prepare for the second sample draw.
  • the working efficiency of the sample addition part 300 is greater than the working efficiency of the reagent distribution part 500.
  • the reagent distribution member 500 can draw different reagent components multiple times and distribute them to the reactor 20 in each working period T.
  • the sample addition part 300 can distribute the samples to at least two reactors 20.
  • each reagent distribution piece 500 can only distribute each reagent component to one reactor 20, while the sample addition piece 300 can distribute samples to at least two reactors 20 .
  • the reagent distributing piece 500 absorbs different reagent components, the reagent distributing piece 500 is cleaned to prevent the carrying contamination of different reagent components; for example, the reagent components of different reagent components include R1 component and R2 component.
  • the accessory 500 sucks the R1 component and the R2 component into the same reactor 20 successively.
  • the reagent distribution piece 500 sucks the R2 component, the reagent distribution piece 500 that has just absorbed the R1 component is cleaned to prevent the R1 component
  • the R2 component constitutes carryover pollution.
  • the sample volume taken by the sample addition part 300 can be set to 10 to 500 ⁇ l each time, and the sample volume required for each reactor 20 is 5 to 250 ⁇ l.
  • the sample adding piece 300 needs to be cleaned, so as to eliminate the problems caused by the sample adding piece 300 extending into the sample tube 430 to suck the sample again and distribute the sample.
  • This will increase the number of cleanings, which will lead to at least the following three defects.
  • First there is a lot of time consumption, which also reduces the working efficiency of the sample addition part 300, thereby affecting the test throughput of the entire immune analyzer 10.
  • Second a large amount of cleaning solution is consumed, which increases the test cost of the immune analyzer 10.
  • the cleaning time of the sample addition piece 300 will be compressed, so that the sample addition piece 300 is not thoroughly cleaned and cannot effectively eliminate carryover pollution.
  • the second liquid distribution method has at least the following beneficial effects.
  • the sample adding piece 300 when the sample adding piece 300 is inserted into the sample tube 430 to absorb the same sample multiple times, the sample adding piece 300 only needs to be cleaned for a short period of time, so that the sample adding piece 300 can be distributed to a certain type of the same sample. , And then centrally allocate another same sample, reduce the frequency of switching between different samples, and further reduce the number of cleaning times and cleaning time of the sample addition 300. Third, since the number of cleaning times of the sample addition piece 300 is reduced, on the basis of ensuring work efficiency and test throughput, the cleaning time of each sample addition piece 300 can be appropriately extended, so that the sample addition piece 300 can be thoroughly cleaned. Effectively reduce the risk of contamination between different samples.
  • the reduction in the number of cleanings will also reduce the consumption of cleaning liquid, which can reduce the test cost of the immune analyzer 10.
  • the ferry unit 200 and the reagent distribution member 500 are coordinated and efficiently moved, which further improves the efficiency of reagent distribution and reactant mixing.
  • the reagent is distributed in the first station 31 by the reagent distributing member 500 to each reactor 20 that has contained the sample, and the sample and reagent are mixed by the ferry unit 200, and the sample is distributed Through the buffer unit, reagent distribution and reactant mixing are completed on the ferry unit, which improves the efficiency of sample, reagent distribution and reactant mixing, thereby improving the test efficiency and throughput of the immune analyzer.
  • the test throughput of the immune analyzer can break through the highest level currently reported in the industry (600 tests per hour), and achieve test throughput of 720, 800 tests per hour or even higher.
  • the diluent can be regarded as a component of the reagent corresponding to the analysis item
  • the sample and the diluent are mixed to form a diluted sample
  • the diluted sample is distributed to multiple reactors 20, and finally the reagents are distributed to the reactor 20 containing the diluted sample and mixed, which can form a sample dilution method.
  • the sample dilution method mainly includes the following steps:
  • S810 Move the first reactor carrying the sample in the ferry unit 200 from the initial station 30 to the first station 31.
  • S820 Distribute the diluent to the first reactor at the first station 31.
  • S840 Move the ferry unit 200 carrying the first reactor containing the diluted sample to the second station 32, and distribute the diluted sample in the first reactor at the second station to at least two vacant second stations.
  • the amount of diluted sample distributed to each vacant second reactor may be different.
  • the amount of diluted sample distributed in one of the second reactors may be greater than The amount of diluted sample dispensed in another second reactor.
  • the second reactor carrying the diluted sample in the ferry unit 200 is moved to the first station 31, and the reagent is distributed to the second reactor at the first station 31.
  • the first reactor is placed on the buffer unit 100, and after the sample is distributed in the first reactor on the buffer unit 100 through the sample addition member 300 , The first reactor containing samples is transferred from the buffer unit 100 to the ferry unit 200 at the initial station 30.
  • the samples are only distributed from the buffer unit 100 (not from the ferry unit 200) to the reactor 20, so that the distribution of samples will not be restricted by the speed and location of the ferry unit 200.
  • the ferry unit 200 carries the reaction
  • samples can be distributed from the buffer unit 100 (not from the ferry unit 200) to the reactor 20, thereby increasing the test throughput of the immune analyzer 10.
  • the empty second reactor is placed on the buffer unit 100.
  • the second reactor containing the diluted sample is removed from the buffer unit at the initial station 30.
  • 100 is transferred to the ferry unit 200.
  • the samples and diluents in the first reactor, and the diluted samples and reagents in the second reactor are all mixed by the ferry unit 200 itself; the method of mixing is non-contact eccentric shaking treatment.
  • the buffer unit 100 is moved between the receiving station 33, the sample loading station 34 and the removing station 35. Both the first reactor and the second reactor enter the buffer unit 100 from the receiving station 33, the sample is distributed from the sample loading station 34 to the first reactor, and the diluted sample is also distributed from the sample loading station 34 to the second reaction In the vessel, both the first reactor and the second reactor leave the buffer unit 100 from the removal station 35 and are transferred to the ferry unit 200.
  • the buffer unit 100 is the turntable 110
  • the turntable 110 drives the first and second reactors to make a circular motion between the receiving station 33, the sample adding station 34, and the removing station 35.
  • the buffer unit 100 is a slider 120
  • the slider 120 drives the first and second reactors to move linearly between the receiving station 33, the sample adding station 34, and the removing station 35.
  • the diluted sample formed by the liquid distribution device 11 can only be used by one reactor 20 each time, that is, the liquid distribution device 11 should perform a separate mixing process for each reactor 20 to form a dilution.
  • the sample in other words, the diluted sample formed by one mixing process corresponds to only one reactor 20. This increases the processing times of mixing to form a diluted sample, thereby reducing the working efficiency of sample dilution, and further affecting the maximum test throughput of the immune analyzer 10.
  • the liquid distribution device 11 mixes the sample and the diluent in the first reactor to form a diluted sample, and distributes the diluted sample in the first reactor to at least two second reactors. in. Therefore, the diluted sample formed by each mixing of the liquid distribution device 11 can be used by at least two reactors 20, which eliminates the need for the liquid distribution device 11 to perform a separate mixing process for each reactor 20 to form a diluted sample, in other words
  • the diluted sample formed by one mixing process can correspond to at least two reactors 20, which can greatly reduce the processing times of mixing to form a diluted sample, improve the working efficiency of the sample dilution method, and improve the maximum test pass of the immunoassay analyzer 10. the amount.
  • a third liquid distribution method can be formed.
  • the third liquid distribution method is similar to the first liquid distribution method, that is, the sample is not distributed from the swing unit to the reactor 20, but from the buffer unit 100 to the reactor 20.
  • the transfer unit transfers the reactor 20 containing the samples from the buffer unit 100 to the ferry unit 200.
  • the third liquid distribution method mainly includes the following steps:
  • S910 Provide at least two ferry units 200, so that each ferry unit 200 reciprocates between the initial station 30 and the first station 31.
  • S920 Transfer the reactor 20 containing the sample to the ferry unit 200 at the initial station 30.
  • the sample is distributed from the buffer unit 100 to the reactor 20.
  • the reactor 20 containing the sample is removed from the buffer unit 100 and moved to the ferry unit 200 at the initial station 30.
  • the ferry unit 200 drives the reactor 20 that is input from the buffer unit 100 and contains samples to move from the initial station 30 to the first station 31, and the reagents are distributed to the reactor 20 at the first station 31, and then The samples and reagents in the reactor 20 are mixed uniformly.
  • the length of the second cycle can be any suitable value within 4-15 seconds, such as 4 seconds, 4.5 seconds, 5 seconds, 6 seconds, 9 seconds, etc., corresponding to
  • the test throughput is 900-240 tests per hour, that is, the immune analyzer 10 can continuously report 900-240 results per hour. To facilitate understanding, the following takes 5 seconds for the second period as an example for description.
  • the ferry unit 200 must also output a reactor 20 that has been homogenized every 5 seconds. If there is only one ferry unit 200, the ferry unit 200 moves into the reactor 20 containing the sample, receives the reagent distributor 500 to dispense the reagents, eccentrically shakes and mixes, and removes and mixes is completed in one cycle. The total time required for the sequence of actions such as the reactor 20 is greater than 5 seconds.
  • the ferry unit 200 will not be able to output a mixed reactor 20 every 5 seconds.
  • the flow rate of the ferry unit 200 is lower than the outlet flow of the pipeline, resulting in The pipeline cannot work continuously at maximum efficiency (test throughput). Therefore, by setting the first period to twice the second period, that is, the first period is 10 seconds, and the number of ferry units 200 is set to two, the sequence of actions performed by the two ferry units 200 is relatively staggered in the second period.
  • the time (ie, 5 seconds) is executed, that is, the two ferry units 200 are "staggered in parallel" after a second cycle.
  • the reactor 20 containing the sample is transferred to the first ferry unit 200 at the 0th second, and then to the second ferry unit 200 at the 5th second
  • the reactor 20 containing the sample is transferred.
  • the reactor 20 on the first ferry unit 200 will output in the 10th second
  • the reactor 20 containing the sample will be transferred to the first swing unit.
  • the reactor 20 on the second ferry unit 200 will output at the 15th second.
  • the reactor 20 containing the sample will be transferred to the second swing unit.
  • the cycle operation will make the first ferry unit 200 output a reactor 20 at the 10th second, 20th second, 30th second,...10N second; meanwhile, the second ferry unit 200 will A reactor 20 is output at the 15th second, 25th second, 35th second, ... (5N+10) second. Therefore, on the basis that each ferry unit 200 outputs a reactor 20 that has been homogenized every 10 seconds, the two ferry units 200 as a whole will output a reactor that has been homogenized every 5 seconds. 20, so as to achieve the purpose of "quantity for time", and finally meet the requirements of the highest test throughput of the immune analyzer 10.
  • the time of the first cycle can be longer.
  • the number of the ferry unit 200 is three, four or more, and the first cycle can be set as the second cycle. Three times, four times or even more, that is, the first period is 15 seconds or 20 seconds, etc.
  • the movement speed of the ferry unit 200 can be reduced, the reagent distribution and the mixing time of samples and reagents can be prolonged, and the bottleneck of the movement speed of the ferry unit 200, reagent distribution and mixing of samples and reagents can be effectively solved.
  • Time bottleneck Under the condition that the moving speed of the ferry unit 200 and the mixing time of the sample and the reagent are constant, each ferry unit 200 still outputs a reactor 20 that has completed the mixing process every 10 seconds, that is, the first cycle is still 10 seconds.
  • the third liquid distribution method further includes the following steps:
  • the storage units 600 equal to the number of the ferry units 200 are provided, and the reagents are stored in the multiple storage units 610 of each storage unit 600.
  • the storage unit 610 follows the storage unit 600 to move to the liquid suction station for sucking reagents.
  • the shortest time window in which the sequence of actions executed by each storage unit 600 can be reproduced cyclically is equal to the first period. From the first time when one of the storage units 600 drives the storage unit 610 to move towards the liquid suction station, it is staggered one second in sequence. The time interval between the cycles causes other storage units 600 to drive the storage unit 610 to move toward the corresponding liquid suction station.
  • the storage unit 610 is moved to the liquid suction station every other first cycle, when all the storage units 600 are regarded as a whole, every second cycle
  • the storage unit 610 will arrive at the liquid suction station at the time of, which can also achieve the purpose of “changing quantity for time”, and finally meet the requirement of the highest test throughput of the immune analyzer 10.
  • the number of storage units 600 is usually one.
  • the number of storage units 610 In order to increase the storage capacity of reagents for analysis items, the number of storage units 610 must be increased, which leads to an increase in the size of the entire storage unit 600.
  • the large occupied area is not conducive to the layout and manufacturing of the storage unit 600.
  • the storage unit 600 with a large volume and weight it also increases the difficulty of its motion control, which causes the storage unit 610 to fail in a short time. Arriving at the designated position for the reagent dispenser 500 to absorb reagents has become a bottleneck in achieving high test throughput. At the same time, when the storage unit 600 fails, the entire immune analyzer 10 will not work.
  • each storage unit 600 has a small volume, which is conducive to overall machine layout and motion control, and can also ensure a large reagent storage capacity.
  • the tolerance of the storage unit 600 to failure can be improved.
  • the other remaining storage units 600 can continue to work to ensure continuous supply of reagents.
  • the faulty storage unit 600 can be refurbished while other storage units 600 are working.
  • reagent dispensing parts 500 equal to the number of storage units 600 such that each storage unit 600 corresponds to one reagent dispensing part 500.
  • the shortest time window in which the sequence of actions performed by each reagent dispenser 500 can be reproduced cyclically is equal to the first cycle. From the time when one of the reagent dispensers 500 dispenses reagents, the time interval of the second cycle is sequentially staggered to make other reagents The sub-assembly 500 dispenses reagents.
  • the number of reagent dispensers 500 and storage units 600 and the number of ferry units 200 are equal, and at the same time
  • the reagent distributor 500 is also "staggered in parallel” every second cycle.
  • all the reagent dispensing pieces 500 as a whole one of the reagent dispensing pieces 500 will dispense reagents every second period of time.
  • the reagent distributing part 500 will dispense the reagent once, which can also achieve the purpose of “changing the quantity for time”, and finally meet the requirement of the highest test throughput of the immune analyzer 10.
  • the storage unit 600 can be divided into two equal halves. One half of the storage unit 600 is opposite to the other half of the storage unit 600.
  • the trajectory of the movement is symmetrical, which is beneficial to the layout of the immune analyzer 10 as a whole.
  • the reactor 20 containing the sample is distributed from the buffer unit 100 to the reactor 20 in advance, eliminating the need for the ferry unit 200 to the reactor 20.
  • the time for distributing samples in the medium thereby reducing the residence time of the reactor 20 on each ferry unit 200, so that each ferry unit 200 can quickly output one reactor 20.
  • the number of ferry units 200 is set to at least two, and at least two ferry units 200 are "staggered in parallel" after a second cycle.
  • the third liquid distribution method is similar to the second liquid distribution method, that is, the same sample is sucked by the sample addition member 300 and continuously distributed to at least two reactors 20 on the buffer unit 100. At the same time, after the same sample is drawn and continuously distributed to at least two reactors, the sample addition member 300 is cleaned or replaced.
  • the second liquid distribution method please refer to the description of the second liquid distribution method.
  • the sample injection part 300 is made to adopt a sample needle or a disposable suction nozzle. After the same sample is drawn and distributed to at least two reactors continuously, the inner and outer walls of the sample needle are cleaned or once The sex nozzle is replaced. For thorough cleaning, the cleaning time for the sample needle is 2 to 10 seconds.
  • the capacity of the sample adding member 300 is greater than the total amount of the same sample required by each reactor 20, the sample adding member 300 only sucks once and distributes the same sample to different reactors 20 in multiple consecutive times.
  • the sample addition part 300 sucks the same sample once (first S) and distributes the first S divided into four parts (denoted as S1, S2, S3, S4, respectively) into the four reactors in four consecutive times. Since the next sample taken by the sample addition piece 300 is a different sample, after allocating S1, S2, S3, S4 to the four reactors, clean the inner and outer walls of the sample needle of the sample addition piece 300 or clean the disposable nozzle Replace it.
  • each reagent distribution piece 500 distributes the reagent corresponding to the analysis item in the first cycle to the first S that has been allocated on the ferry unit 200 at the first station.
  • the two reagent distributors 500 are separated by N second cycles to distribute the reagents corresponding to the analysis items to the first S-allocated reactor on the ferry unit 200 at the ferry position at the first station 31 Inside.
  • the first reagent distribution member 500 distributes the reagent to the first reactor 20 containing S1 in the first first period T, and distributes the reagent to the third reactor 20 containing S3 in the second first period T.
  • the second reagent distribution piece 500 distributes reagents to the second reactor 20 containing S2 in the second first cycle T, and distributes reagents to the fourth reactor 20 containing S4 in the third first cycle T. It can be seen that the first reagent The sub-assembly 500 and the second reagent distributing member 500 are separated by N second cycles (T/2) to distribute the reagents corresponding to the analysis items. In this way, it can be ensured that each second period (T/2) has a reactor 20 to complete the distribution of reagents, thereby improving the efficiency of reagent distribution.
  • each reagent distributing piece 500 is sequentially staggered for a second cycle (T/2) and the analysis items are distributed at intervals of N (N is an integer and N ⁇ 1) first cycle.
  • T/2 the second cycle
  • N is an integer and N ⁇ 1 first cycle.
  • the third liquid distribution method of the present application improves the sample distribution efficiency and effectively reduces the pollution carried between samples, so that at least two ferry units 200, at least two storage units 600, and at least two reagent distribution pieces 500 Efficient and coordinated movement further improves the efficiency of reagent distribution and reactant mixing, thereby improving the test efficiency and throughput of the immune analyzer.
  • the test throughput of the immune analyzer of this application can break through the highest reported in the industry. Level (600 tests per hour) to achieve test throughput of 720, 800 tests per hour or even higher.
  • This application also provides an immunoassay method, which includes the steps in the first liquid distribution method, the second liquid distribution method, the third liquid distribution method, and the sample dilution method described above.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Analytical Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Microbiology (AREA)
  • Cell Biology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Biotechnology (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)

Abstract

一种液体分配装置(11),包括:缓存单元(100),能够接收并带动反应器(20)运动,缓存单元(100)上的反应器(20)用于分配样本;摆渡单元(200),靠近缓存单元(100)设置,摆渡单元(200)能够带动从缓存单元(100)上输入已分配样本的反应器(20)做直线运动,摆渡单元(200)上的已分配样本的反应器(20)用于分配试剂,摆渡单元(200)对分配试剂后的反应器(20)中的反应物混匀;其中,在摆渡单元(200)承载已分配样本的反应器(20)运动或静止的过程中,样本能够同时分配至缓存单元(100)上空置的反应器(20)中。

Description

液体分配装置和免疫分析仪
相关申请的交叉引用
本申请要求于2019年02月02日提交中国专利局、申请号为2019101074166、发明名称为“液体分配装置和免疫分析仪”的中国专利申请的优先权,其全部内容通过引用结合在本申请中。
技术领域
本申请涉及体外诊断技术领域,特别是涉及一种液体分配装置和包含该液体分配装置的免疫分析仪。
背景技术
全自动免疫分析仪能够对血液等待测样本中所含的抗体和抗原等目标分析物质进行定量或定性检测,通常将空置的反应器中分配待测样本和试剂(或称反应物)并经过混匀、孵育和清洗分离(Bound-free,结合分离,即BF分离)等步骤后,再在反应器中分配信号试剂以测量光信号或电信号,从而实现对待测样本中所含目标分析物质的测量分析。
衡量免疫分析仪工作效率的一个重要参数为测试通量,测试通量可以理解为免疫分析仪在单位时间内可以报告测试结果的数量,即对含有目标分析物的反应器的测量个数,单位时间内所测量的反应器的总数量越多,免疫分析仪的测试通量越高。由于分析项目的反应模式和测试流程通常不同,免疫分析仪的测试通量不是一成不变的,通常将最大测试通量作为免疫分析仪测试快慢的衡量标准,本申请为了叙述方便,除非特别说明,测试通量特指分析仪的最大测试通量。将免疫分析仪对反应器的处理看成为流水线,如果单位时间内存在N个含有目标分析物的反应器完成测量而离开流水线,为保证测试按最大通量连续可靠的进行,则必须在相同时间内同样有N个空置的反应器进入流水线,即反应器在流水线进口处的流量(进口流量)与出口处的流量(出口流量)相等。同理,为确保整条流水线无缝、连续衔接,反应器在流水线中间各个环节的流量应与进口流量、出口流量相等,即流水线各处流量均相等。
一般地,在向反应器中分配样本和试剂的过程中,要么因部件工作效率太低而无法满足测试通量要求,要么在满足测试通量的基础上会增大部件的工作负荷。
发明内容
本申请解决的一个技术问题是如何提高液体分配装置的工作效率。
一种液体分配装置,包括:
缓存单元,能够接收并带动反应器运动,所述缓存单元上的反应器用于分配样本;及
摆渡单元,靠近所述缓存单元设置,所述摆渡单元能够带动从所述缓存单元上输入已分配样本的反应器做直线运动,所述摆渡单元上的已分配样本的反应器用于分配试剂,所述摆渡单元对分配试剂后的反应器中的反应物混匀;
其中,在摆渡单元承载已分配样本的反应器运动或静止的过程中,样本能够同时分配至缓存单元上空置的反应器中。
一种免疫分析仪,包括上述的液体分配装置。
本申请
附图说明
为了更清楚地说明本申请实施例或现有技术中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本申请的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他的附图。
图1为第一实施例提供的第一示例免疫分析仪的平面结构示意图。
图2为图1中包含有摆渡单元的局部立体结构示意图。
图3为第一实施例提供的第二示例免疫分析仪的平面结构示意图。
图4为第一实施例提供的第三示例免疫分析仪的平面结构示意图。
图5为第二实施例提供的免疫分析仪的平面结构示意图。
图6为将相同样本连续分配到至少两个反应器中的示意图。
图7为样本和试剂分配至反应器的时序图。
图8为对至少两个反应器提供稀释样本的示意图。
图9为第一种液体分配方法的流程框图。
图10为第二种液体分配方法的流程框图。
图11为样本稀释方法的流程框图。
图12为第三种液体分配方法的流程框图。
图13为第三种液体分配方法的样本和试剂分配至反应器的时序图。
具体实施方式
为了便于理解本申请,下面将参照相关附图对本申请进行更全面的描述。附图中给出了本申请的较佳实施方式。但是,本申请可以以许多不同的形式来实现,并不限于本文所描述的实施方式。相反地,提供这些实施方式的目的是使对本申请的公开内容理解的更加透彻全面。
需要说明的是,当元件被称为“固定于”另一个元件,它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件,它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“内”、“外”、“左”、“右”以及类似的表述只是为了说明的目的,并不表示是唯一的实施方式。
同时参阅图1至图8,样本和试剂(或称反应物)孵育特指反应器20开始清洗分离前,其内的反应物在恒温环境下发生的抗原抗体结合反应或生物素亲和素结合反应的过程。这里所述的试剂与分析项目为“一一对应”关系,即不同分析项目对应的具体试剂在配方、试剂量、组分数量等方面一般不同。根据具体分析项目的不同,试剂通常包括多个组分,如常见的2-5个组分,包括磁粒、标记、稀释液、解离剂等试剂组分(对应的各试剂组分可分别用R1、R2、R3、R4表示)。例如T4试剂(thyroxine,甲状腺素)包含磁粒(R1)、标记(R2)、解离剂(R4)三个组分。根据反应模式不同,一个分析项目的多个试剂组分可以一次性分配也可以分多个步骤分配,分步骤分配时按照分配次序定义为第一试剂、第二试剂、第三试剂等。孵育完成后进行清洗分离,清洗分离指用磁场捕捉结合后的磁粒、标记的复合物,同时去除含游离(Free,游离)的标记物及其他未反应或结合成分(本文为表述方便,简称未结合成分)的过程。清洗分离后分配信号试剂,进行信号孵育(一般为1-6分钟),最后测量标记试剂与信号试剂反应产生的发光量(本文为表述方便,称为反应物信号)。信号试剂用于测量信号(通常为发光量)的产生,通常为通用试剂的一种,与分析项目为“一对多”的对应关系,即不同的分析项目共用信号试剂。信号孵育指清洗分离后的反应器20在分配信号试剂后,在恒温环境下反应一段时间,使信号增强的过程。需要指出的是,由于信号试剂具体成分的不同,有些发光体系不需要信号孵育,在分配信号试剂过程中或分配完信号试剂后可以直接测量。信号试剂可以是一种或多种,如有些信号试剂包括第一信号试剂、第二信号试剂等。在免疫分析装置中,经过上述过程,定量或定性测定与标记试剂结合的样本中所含抗原或抗体。此外,免疫分析仪10能够对样本进行与数种不同的分析项目相应的分析。
工作周期或循环,简称周期,是在测试过程中可循环重现的最短时间窗口,其通常具有固定的时间长度,在周期时间内,一定数量的过程操作、任务或工作包等,比如取液、混匀、孵育、清洗分离、测量等操作和任务,按照受控的顺序串行或并行执行。同一部件在一个周期内的任务通常串行执行,不同部件在同一个周期内的任务,取决于相关部件间的动作是否有依赖关系,可以串行执行或并行执行。在一个周期中执行的所有过程操作只有在需要时才执行,不一定会在另一个周期中重复。特别是, 某些过程操作可以在每个周期中重复出现,而其它的可能会每两个或更多个周期发生一次。当多个测试连续进行时,由于每个测试通常处在测试进程的不同阶段,在单个周期内发生的所有的过程操作中,只有某些过程操作专用于执行一个测试,另外一些过程操作用于执行其它的测试。为了提高测试效率和通量,对于存在速度瓶颈的部件,可以通过增加部件的数量和延长部件的周期来实现,这样不同部件的工作周期不一定相同,即同一系统中可能存在多个并行的周期,通常并行的多个周期的时间长度存在倍数关系,倍数通常等于同一部件的个数。当存在两个工作周期时,分别称为第一周期、第二周期,比如摆渡单元200数量为N个(N≧2,为自然数)时,每个摆渡单元200工作在第一周期,第一周期长度为第二周期的N倍,且N个摆渡单元200的动作序列连续“错开并行”第二周期。
需要指出的是,并不是所有部件或操作都按工作周期工作,有些部件或操作的工作过程对测试性能或测试结果没有影响,可以不按照固定的周期工作,比如反应器20的供给,可以没有固定的工作周期。
参阅图1至图5,本申请一实施例提供的免疫分析仪10包括液体分配装置11和反应装置12,液体分配装置11位于反应装置12的旁侧,液体分配装置11用于在反应器20中完成样本和试剂的分配、以及样本和试剂的混匀。反应装置12用于将反应器20中混匀处理后样本和试剂(反应物)进行孵育、清洗分离和测量。
液体分配装置11包括缓存单元100、供给料仓130、供给滑道140、摆渡单元200、加样件300、样本输送单元400、试剂分配件500、存储单元600、移送单元700、清洗池800和排序机构。当然,液体分配装置11还可以包括加样驱动单元301和试剂驱动单元501以及加样动力器和试剂分配动力器,加样件300安装在加样驱动单元301上,加样驱动单元301用于带动加样件300运动以便加样件300在加样动力器作用下吸取或排除样本。试剂分配件500安装在试剂驱动单元501上,试剂驱动单元501用于带动试剂分配件500运动以便试剂分配件500在试剂分配动力器下吸取或排放试剂。加样动力器和试剂分配动力器可采用通用的注射器、柱塞泵、定量泵等流体定量器件。
样本输送单元400可以包括样本架410、样本管430和输送轨道420,样本架410可以与输送轨道420配合,样本管430放置在样本架410上,样本管430用于盛放样本,例如,每个样本架410上可以放置五个至十个左右的样本管430。当样本架410带动样本管430沿输送轨道420运动至指定位置时,加样件300吸取样本管430的样本,并将样本分配至空置的反应器20中。
供给料仓130用于存放洁净且空置的反应器20,排序机构可以用于将来自供给料仓130的散乱放置的反应器20进行整理以按一定秩序排列,供给滑道140将排序后的反应器20逐个导入至缓存单元100,缓存单元100用于缓存供给滑道140输送过来的反应器20。
参阅图1,在一些实施例中,整个液体分配装置11具有接收工位33、加样工位34和移出工位35。缓存单元100包括转盘110,转盘110能够绕自身的中心轴线做旋转运动,转盘110上设置有多个缓存位101,缓存位101用于承载反应器20,缓存位101可以为容置孔,当然,容置孔还可以采用托架等实体结构进行替换,只要能将反应器20放置在转盘110上即可。缓存位101沿转盘110的周向间隔分布,当转盘110旋转时,可以带动缓存位101在接收工位33、加样工位34和移出工位35之间运动,从而使转盘110上的反应器20在接收工位33、加样工位34和移出工位35之间运动。显然,转盘110带动反应器20在接收工位33、加样工位34和移出工位35之间做圆周运动。
具体而言,来自供给滑道140上的反应器20将于接收工位33进入转盘110上的缓存位101,当转盘110带动该空置反应器20运动到加样工位34时,加样件300可以从样本管430中吸取样本以将其分配至反应器20中,当转盘110带动已盛放有样本的反应器20继续运动到移出工位35后,移送单元700将已盛放有样本的反应器20于移出工位35脱离转盘110而移送至摆渡单元200。
缓存位101沿转盘110的周向间隔排列,缓存单元100可以仅排列成形成一个缓存圈,该缓存圈靠近转盘110的边缘设置。当然,缓存位101还可以排列形成多个缓存圈,多个缓存圈环绕转盘110的中心轴线同心设置。
参阅图3,在一些实施例中,缓存单元100包括滑块120,滑块120上同样设置有用于放置反应器20的缓存位101,滑块120上的该缓存位101可以同样为容置孔,缓存位101可以仅在滑块120上沿 直线间隔分布形成一排。当然,缓存位101可以在滑块120上沿直线间隔分布形成多排,此时,多排缓存位101在滑块120上呈矩阵式分布排列。滑块120在接收工位33、加样工位34和移出工位35之间直线运动,从而带动其上的缓存位101(对应反应器20)在接收工位33、加样工位34和移出工位35之间运动。同样地,参考上述转盘110的工作模式,反应器20于接收工位33进入滑块120,加样件300对位于加样工位34处的反应器20中分配样本,移送单元700将已盛放有样本的反应器20于移出工位35脱离滑块120而移送至摆渡单元200。该实施例中,滑块120和其上的缓存位101在接收工位33、加样工位34和移出工位35之间直线往复运动,完成反应器20的接收、样本分配和已盛放有样本的反应器20的移出,滑块120本身体积可以设计得更小,同时,滑块120直线运动轨迹所覆盖区域的面积较小,这样有利于供给料仓130、供给滑道140、样本输送单元400、加样件300、移送单元700等的空间优化布局,可使液体分配装置11更为紧凑,成本更低。
参阅图4,在一些实施例中,缓存单元100同时包括均设置有缓存位101的转盘110和滑块120,转盘110绕自身中心轴线做旋转运动,转盘110能够带动其上的缓存位101经过接收工位33,供给滑道140上的反应器20将于接收工位33进入转盘110上的缓存位101。滑块120在加样工位34和移出工位35之间做直线运动,当转盘110带动空置反应器20从接收工位33旋转设定角度后,移送单元700可以将空置反应器20脱离转盘110并移送至处于移出工位35的滑块120上,当滑块120带动反应器20运动到加样工位34后,加样件300向空置反应器20中分配样本,随后,滑块120带动盛放有样本的反应器20运动到移出工位35后,移送单元700将盛放有样本的反应器20从移出工位35脱离滑块120而移送至摆渡单元200上。
参阅图2,在一些实施例中,液体分配装置11还包括机架210、传送器220、支座230和驱动器240,传送器220设置在机架210上,传送器220用于带动支座230相对机架210滑动,传送器220包括电机221、主动轮222、从动轮223和同步带224,电机221用于驱动主动轮222转动,同步带224缠绕在主动轮222和从动轮223上,当电机221转动时,主动轮222和从动轮223带动同步带224移动。当然,在其它实施例中,传送器220还可以由丝杆机构、齿轮齿条等传动机构的一种或几种进行替换。
具体地,机架210上可以设置滑轨225,支座230与滑轨225配合,同步带224与支座230连接并驱动支座230沿滑轨225延伸的方向滑动,驱动器240和摆渡单元200均设置在支座230上,摆渡单元200用于放置反应器20,驱动器240能够带动摆渡单元200产生偏心震荡,从而使反应器20中的样本和试剂(反应物)因产生非接触式偏心震荡而实现混匀。
摆渡单元200上可以设置多个收容孔,反应器20插置在该收容孔中,从而实现摆渡单元200对反应器20的承载作用。当然,收容孔还可以采用托架等实体结构进行替换,只要能将反应器20放置在摆渡单元200上即可。
在一些实施例中,整个液体分配装置11还具有初始工位30和第一工位31,当电机221运动时,可以使摆渡单元200在初始工位30和第一工位31之间做往复直线运动。当摆渡单元200位于初始工位30时,对于来自缓存单元100上盛放有样本的反应器20,移送单元700可以将其移送至位于该初始工位30的摆渡单元200上。接着,摆渡单元200带动盛放有样本的反应器20运动到第一工位31,试剂分配件500将从用于存储试剂的存储单元600中吸取试剂、并将试剂分配至位于第一工位31的反应器20中。然后,摆渡单元200在直线运动过程中,驱动器240可以带动摆渡单元200产生偏心震荡,从而使反应器20中的样本和试剂进行混匀,这样可以使反应物的混匀和摆渡单元200的运动并行进行,即摆渡单元200在运动过程中能够同时对反应器20中的反应物进行混匀,提高混匀效率和混匀效果,从而提高整机的测试通量。当然,在摆渡单元200运动前后的静止过程中,驱动器240也可以带动摆渡单元200产生偏心震荡使反应器20中的样本和试剂进行混匀。摆渡单元200将分配试剂后的反应器20返回至初始工位30,移送单元700可以将反应物已混匀的反应器20从初始工位30脱离摆渡单元200而移送至反应装置12,以便反应器20在反应装置12上进行孵育、清洗分离和测量处理。
由此可见,驱动器240直接对摆渡单元200形成偏心震荡,使摆渡单元200上的反应器200内的反应物实现混匀,不需要额外的独立混匀装置,摆渡单元200的直线运动或静止状态并不限制反应器 200中反应物的混匀,解决了现有技术混匀装置复杂、混匀效率低下和混匀效果不好等问题。此外,摆渡单元200在加样件300、移送单元700、试剂分配件500之间做直线运动,一方面直线运动的控制难度减低,使摆渡单元200运动更精准高效,避免摆渡单元200偏离指定停靠位置,确保摆渡单元200能够准确且及时地停靠在初始工位30或第一工位31,保证盛放有样本的反应器20能够顺利于初始工位30转移至摆渡单元200上,也能保证试剂分配件500可靠地将试剂于第一工位31加入至反应器20中;另一方面将盛放有样本的反应器20承载在缓冲单元100上以等待移送至摆渡单元200加入试剂并混匀,无需将盛放有样本的反应器20全部转移至摆渡单元200上,这样充分利用了缓存单元100的承载空间,使得摆渡单元200同一时刻所承载的反应器20的数量减少,确保摆渡单元200的体积设计得更小,结构更为紧凑;同时,摆渡单元200直线运动轨迹所覆盖区域的面积较小,解决了现有技术加样件300、移送单元700、试剂分配件500必须沿着大半径的旋转或回转盘布局的限制,优化了部件或单元间的空间布局和控制流程,可以更加高效连接和协调加样件300、移送单元700、试剂分配件500之间的逻辑动作,不仅可使免疫分析仪更为紧凑,而且提升了总体的工作效率。
通过将缓存单元100上的反应器20用于分配样本,将分配样本后的反应器20移送至摆渡单元200上分配试剂并混匀,使得样本的分配和试剂的分配分别在不同的独立单元上实现、混匀直接在摆渡单元上实现,解决了现有技术样本的分配和试剂的分配相互限制的问题以及在特定工位单独对反应物混匀的问题,提升了液体分配和混匀的效率。
在一些实施例中,存储单元600为可转动的圆盘,存储单元600靠近第一工位31设置,存储单元600上设置多个存储部610,存储部610用于放置和存储试剂容器,试剂则盛放在试剂容器中,试剂分配件500用于吸取存储部610上的试剂容器内的试剂组分,并将试剂组分分配至处于第一工位31的反应器20中。存储部610的数量可以根据需要而设置,考虑到使用需求、成本和布局,每个存储单元600上的存储部610的数量最好为15-50个,比如每个存储单元600上的存储部610的数量都为25个,这样两个存储单元600一共可以同时在线存储50个试剂容器。每个存储单元600存放相应分析项目所需的全部试剂组分,例如,在一个分析项目中,必须向反应器20中分配磁粒、标记和解离剂共三个试剂组分,则将磁粒、标记和解离剂三个组分盛放在同一个存储单元600上。当某个分析项目需要装载多个试剂容器以扩充该项目的上机测试量时,多个试剂容器可以按任何合适的组合存放于每个存储单元600。比如存储单元600数量为2个时,需要装载3个每个含100个测试的TSH(thyroid stimulating hormone,促甲状腺激素)试剂容器,可以将3个TSH试剂容器都装载在同一个存储单元600,也可以1个TSH试剂容器装载在其中一个存储单元600、另外2个装载在另一个存储单元600。当存储单元600间歇性转动时,可以带动存储部610运动到指定的吸液工位,以便试剂分配件500在吸液工位吸取存储部610上的试剂并将其分配至反应器20中。
在存储部610跟随存储单元600转动(公转)的过程中,使存储部610上的试剂容器的至少一个腔(如盛放磁粒试剂组分的磁粒腔)绕其自身的中心轴线产生自转,使得以固体悬浮液形式存在的磁粒试剂组分产生涡旋,避免其中的固体物质(例如磁粒)产生沉淀。存储单元600上还可以设置扫描器,扫描器可以识别存储部610上试剂容器的条码信息,从而用以区分不同的试剂。存储单元600上还可以设置制冷器,制冷器可以对存储部610中的试剂进行冷藏处理,从而实现在线长期保存试剂。
移送单元700用于将反应器20在摆渡单元200、缓存单元100和反应装置12之间移送,移送单元700可以做水平运动和垂直运动,显然,移出工位35和初始工位30均处于移送单元700的运动轨迹之上。
当采用该液体分配装置11对反应器20中分配样本和试剂、并将样本和试剂进行混匀处理时,可以形成第一种液体分配方法,该第一种液体分配方法的主要特点在于:样本从缓存单元100(并非从摆渡单元200)分配至反应器20中。参阅图9,该第一种液体分配方法主要包括如下步骤:
S510,提供用于接收并带动反应器20运动的缓存单元100,向位于缓存单元100上空置的反应器20中分配样本;
S520,使摆渡单元200停止在初始工位30,将已分配样本的反应器20从缓存单元100移送至位于初始工位30的摆渡单元200上;
S530,使摆渡单元200在初始工位30和第一工位31之间运动,向位于第一工位31处的反应器20中分配试剂;当然,可以使摆渡单元200在初始工位30和第一工位31之间做直线运动。其中,在摆 渡单元200承载已分配样本的反应器20运动或静止的过程中,样本能够同时被分配至缓存单元100上空置的反应器20中。
S540,当反应器20中分配试剂后,使摆渡单元200对样本和试剂进行混匀处理。摆渡单元200可以通过非接触偏心震荡的方式对反应器20中的反应物进行混匀处理,从而消除其它接触式搅拌对反应物构成的携带污染。为提高测试通量,可以在从第一工位31运动到初始工位30的过程中,使摆渡单元200对反应器20中的样本和试剂进行混匀处理。
S550,使摆渡单元200停止在初始工位30,样本和试剂混匀完成后,通过移送单元700将反应器20从初始工位30离开摆渡单元200并移送至反应装置12上。
在该第一种液体分配方法中,将摆渡单元200执行的上述步骤S520、S530,S540,S550中的动作序列可循环重现的最短时间窗口记为工作周期T,使摆渡单元200在一个工作周期T内在初始工位30接收已分配样本的反应器20、直线运动到第一工位31处接受反应器20中分配试剂、对反应器20中的反应物进行混匀、直线运动到初始工位30处使反应器20离开。
将向位于缓存单元100上空置的至少两个反应器20中连续分配样本之间的时间间隔记为样本分配间隔t,t=T或者存在至少一个t,使得t﹤T。t=T时,每个工作周期T的间隔内,向位于缓存单元100上空置的反应器20中分配一次样本。特别地,t﹤T时,在工作周期T的间隔内向位于缓存单元100上空置的反应器20中分配不止一次样本。存在至少一个t,使得t﹤T时,向位于缓存单元100上空置的反应器20中分配样本的时间不固定,可以不受工作周期T的限制,根据测试的需要决定分配样本的间隔,使测试更灵活高效。
该第一种液体分配方法中,样本只从缓存单元100分配至反应器20中,并不从摆渡单元200分配至反应器20中,这样可以省去从摆渡单元200向反应器20中分配样本的时间,提高了液体分配装置工作效率。在一些实施例中,当缓存单元100仅包括做圆周运动的转盘110或仅包括做直线运动的滑块120时,向缓存单元100中分配样本的步骤包括如下子步骤:
将反应器20从接收工位33输入至缓存单元100上;
将反应器20跟随缓存单元100从接收工位33运动至加样工位34,向位于加样工位34处的反应器20中分配样本;及
将反应器20跟随缓存单元100从加样工位34运动至移出工位35,反应器20能够从移出工位35被移送至摆渡单元200。
在一些实施例中,当缓存单元100同时包括圆周运动的转盘110和做直线运动的滑块120时,向缓存单元100中分配样本的步骤包括如下子步骤:
将反应器20从接收工位33输入至缓存单元100的转盘110上;
将转盘110绕自身的中心轴线运动,反应器20跟随转盘110旋转设定角度;
将反应器20从转盘110移送至缓存单元100的滑块120上,反应器20跟随滑块120做直线运动至加样工位34,向位于加样工位34处的反应器20中分配样本;及
将反应器20跟随滑块120从加样工位34做直线运动至移出工位35,反应器20能够从移出工位35被移送至所述摆渡单元200。
为保证最大测试通量,必须在规定的时间内从摆渡单元200上移出一个反应物已混匀处理完成的反应器20。因此,当单个反应器20从进入摆渡单元200直至离开摆渡单元200所间隔的时间(即单个反应器20在摆渡单元200上的总停留时间)越短,测试通量越大。而对于传统将样本和试剂均从摆渡单元200分配至反应器20的方案,由于均从摆渡单元200对其上的反应器20分配样本和试剂,故反应器20在摆渡单元200上的停留时间将至少包括样本分配时间、试剂分配时间、摆渡单元200运动时间和反应物混匀时间。
而对于该第一种液体分配方法,样本只从缓存单元100分配反应器20中(样本并不从摆渡单元200分配反应器20中),即样本只分配位于缓存单元100的反应器20中;当盛放有样本的反应器20从缓存单元100移送至摆渡单元200后,试剂将分配至位于摆渡单元200上已盛放有样本的反应器20中。因此,与传统方案相比较,在加样件300和试剂分配件500两者工作效率相同、以及摆渡单元200运行速度相同的基础上,反应器20在摆渡单元200上的停留时间仅包括试剂分配时间、摆渡单元200运动时间和反应物混匀时间,从而省去了样本分配时间,反应器20在摆渡单元200上停留时间较短,使得反应器20能在相对较短的时间内将反应物混匀而离开摆渡单元200,提高整个免疫分析仪10的测试通量。
事实上,对于该第一种液体分配方法,样本的分配不会受摆渡单元200运动速度和所处位置的限 制,当摆渡单元200承载已分配样本的反应器20在运动或静止的过程中,加样件300均可以充分利用该空闲的等待时间,从而将样本从缓存单元100上事先分配至反应器20中,压缩单个反应器20在摆渡单元200上的总停留时间,最终达到提高最大测试通量的目的。因此,即便在试剂分配件500从摆渡单元200向其上的反应器20中分配试剂的同时,加样件300可以从缓存单元100向其上的反应器20中分配样本,即样本和试剂的分配可以同步进行,从而消除在摆渡单元200上的样本分配时间。而对于传统的方案,样本的分配无法摆脱摆渡单元200运动速度和所处位置的限制,只有当摆渡单元200抵达至初始工位30时,加样件300才能从摆动单元向反应器20中分配样本,不可能实现在同一时刻向反应器20中分配样本和试剂。
当然,在保证与传统方案测试通量相同的基础上,对于该第一种液体分配方法,还可以适当降低摆渡单元200、加样件300与试剂分配件500的运行速度(工作效率或工作负荷),从而降低对摆渡单元200、加样件300与试剂分配件500三者运动控制的难度,也会减少液体分配装置11中各部件因高速运行而产生的振动、噪音和故障,提高整个液体分配装置11运行的平稳性与可靠性。
当采用上述液体分配装置11对反应器20中分配样本和试剂、并将样本和试剂进行混匀处理时,还可以形成第二种液体分配方法,该第二种液体分配方法的主要特点在于:通过加样件300吸取相同样本分多次分配到至少两个反应器20中;同时,在吸取相同样本连续分配到至少两个反应器后,将加样件300进行清洗或更换,在吸取相同样本连续分配到至少两个反应器之间,加样件300不进行清洗或更换。参阅图10,该第二种液体分配方法主要包括如下步骤:
S710,提供加样件300,同时提供缓存单元100和摆渡单元200。
S720,通过加样件300吸取相同样本连续分配到缓存单元100的至少两个反应器20中,将向位于缓存单元100上空置的至少两个反应器20中连续分配样本之间的时间间隔记为样本分配间隔t。本领域技术人员可以理解,此处相同样本特指需要进行至少两次检测的同一待检样本(即对应某一被检者,如某病人的样本),该至少两次检测可以是至少两个不同的分析项目,也可以是相同的分析项目至少重复两次检测;不同样本指不同被检者的样本。
S730,在吸取相同样本连续分配到至少两个反应器后,将加样件300进行清洗或更换。在吸取相同样本连续分配到至少两个反应器之间,加样件300不进行清洗或更换。特别地,在分配不同样本之间,将加样件300进行清洗或更换。
S740,将摆渡单元200执行的动作序列可循环重现的最短时间窗口记为工作周期T,使摆渡单元200在初始工位30和第一工位31之间运动,通过试剂分配件500将试剂于第一工位31分配至每个已盛放有样本的反应器20中,具体地,通过试剂分配件500将试剂于第一工位31分配至摆渡单元200上的每个已盛放有样本的反应器20中。与摆渡单元200相同,试剂分配件500同样按工作周期T分配试剂,即每个工作周期T内只向一个已盛放有样本的反应器20分配试剂。因此,对于加样件300按样本分配间隔t分配样本后的至少两个反应器,其被同一个试剂分配件500分配试剂的间隔时间至少为T。
S750,当反应器20中分配试剂后,使摆渡单元200对样本和试剂进行混匀处理。摆渡单元200可以通过非接触偏心震荡的方式对反应器20中的反应物进行混匀处理,从而消除其它接触式搅拌对反应物构成的携带污染。为提高测试通量,可以在从第一工位31运动到初始工位30的过程中,使摆渡单元200对反应器20中的样本和试剂进行混匀处理。
S760,样本和试剂混匀完成后,通过移送单元700将反应器20从初始工位30离开摆渡单元200并移送至反应装置12上。
第二种液体分配方法的其它相同之处可以参考上述第一种液体分配方法,在此不再赘述。
在一些实施例中,加样件300采用呈细长状的圆柱型样本针,在吸取相同样本连续分配到至少两个反应器后,特别地,在分配不同样本之间,将样本针运动到清洗池800,对样本针的内壁和外壁同时进行清洗,以清除不同样本之间的携带污染。清洗时,通过注射器或泵等流体动力器件往样本针的内腔中注入清洗液,以一定速度流过样本针的内腔的清洗液将对样本针内壁进行冲刷而达到清洗效果,同时,对样本针的外壁喷洒或浸入清洗液以对其进行清洗,从样本针内腔和外壁上流出的清洗液可以同时排入清洗池800中。为确保样本针的内壁和外壁的彻底清洗以消除携带污染,同时保证样本针的工作效率和免疫分析仪10的测试通量,对样本针进行清洗的时间为2秒至10秒。
在一些实施例中,加样件300采用一次性吸嘴,在吸取相同样本连续分配到至少两个反应器20后,对一次性吸嘴进行更换,特别地,在分配不同样本之间,对一次性吸嘴进行更换。这样可以省去对一次性吸嘴的清洗,减少清洗时间以提高效率,同时,可以通过减少清洗液的成本消耗以弥补一次性吸 嘴的成本消耗。
同时参阅图6和图7,在一些实施例中,当待检样本对应的所有分析项目所需样本之和并未超过样本针容量时,即当加样件300的容量大于各反应器20所需相同样本的总量时,加样件300仅吸取一次并连续分多次将相同样本分配至不同的反应器20中。例如,加样件300需要吸取相同血液样本(记为第一S)以检测甲功五项中的两个项目,即TSH项目和T4项目,对于检测TSH项目的反应器20,该反应器20(记为TSH反应器)需要100微升血液样本;对于检测T4项目的反应器20,该反应器20(记为T4反应器)需要50微升血液样本。此时,加样件300的容量大于150微升,即加样件300的容量大于TSH反应器与T4反应器所需血样样本容量的总和,因此,加样件300从样本管430中一次性吸取至少150微升血液样本(第一S),分配血液样本时,缓存单元100带动TSH反应器运动到加样工位34,加样件300向TSH反应器中分配100微升血液样本(第一S);然后,缓存单元100继续带动T4反应器运动到加样工位34,样本分配间隔t后(存在至少一个t,使得t﹤T),加样件300向T4反应器中分配50微升血液样本(第一S)。在向TSH反应器和T4反应器分配血液样本之间,由于是相同的血液样本,无需对加样件300进行清洗,当然,可以将加样件300运动到清洗池800上方或清洗池800中进行回程差校准,也可以停留在加样工位34处。试剂分配件500随后向TSH反应器分配TSH试剂,该TSH试剂可以包括R1组分和R2组分,并至少间隔一个工作周期T后向T4反应器分配T4试剂,该T4试剂同样可以包括R1组分和R2组分。
在一些实施例中,当待检样本对应的所有分析项目所需样本之和超过样本针容量时,即当加样件300的容量小于各反应器20所需相同样本的总量时,加样件300分多次吸取相同样本(记为第二S)并按样本分配间隔t(存在至少一个t,使得t﹤T)将其分配至不同的反应器20中。例如,需要向四个反应器20中分配相同样本(第二S)以检测四个不同项目,假如加样件300的容量为500微升,而四个反应器20所需的相同样本的总量超过500微升,此时,加样件300可以分两次吸取以向四个反应器20中分配相同样本(第二S)。操作时,加样件300第一次吸取少于500微升的样本(第二S),并连续分三次按设定量分配至三个反应器20中,然后,加样件300第二次吸取少于500微升的样本,并设定量将其分配至最后一个反应器20中。在加样件300第一次和第二次吸取相同样本(第二S)之间,将加样件300运行到清洗池800中对加样动力器进行复位处理。由于复位需要在对加样件300的清洗过程中进行,而相同样本之间不存在携带污染问题,故仅需对加样件300进行较短时间清洗,以便加样件300为更好地完成第二次样本吸取做好准备。
在一些实施例中,对于样本分配间隔t,存在至少一个t,使得t﹤T,即存在至少一个工作周期T的间隔内,加样件300的工作效率大于试剂分配件500的工作效率。对于已分配样本的同一反应器20,试剂分配件500在每个工作周期T内可分多次吸取不同试剂组分分配至反应器20中。在试剂分配件500将各所需试剂组分分配至单个反应器20的工作周期T的时间间隔内,加样件300能够将样本分配到至少两个反应器20中。简而言之,在工作周期T的时间间隔内,每个试剂分配件500仅能对一个反应器20中分配各个试剂组分,而加样件300能够对至少两个反应器20中分配样本。在试剂分配件500吸取不同试剂组分之间,对试剂分配件500进行清洗以防止不同试剂组分的携带污染;例如,不同的试剂组分试剂组件包括R1组分和R2组分,试剂分配件500先后吸取R1组分和R2组分至同一反应器20中,当试剂分配件500在吸取R2组分之前,将刚吸取过R1组分的试剂分配件500进行清洗,以防止R1组分对R2组分构成携带污染。
根据实际情况的需要,可以使加样件300每次吸取的样本量设置为10微升至500微升,每个反应器20所需的样本量为5微升至250微升。
对于传统的方案,当加样件300每对一个反应器20分配样本后,均需将加样件300进行清洗,以便消除加样件300伸入样本管430中再次吸取样本和分配样本后导致的携带污染,这样会使得清洗次数增多,从而至少导致如下三个缺陷,第一,存在大量时间消耗,也降低了加样件300的工作效率,从而影响整个免疫分析仪10的测试通量。第二,消耗大量的清洗液,增加免疫分析仪10的测试成本。第三、由于清洗次数较多,为保证加样件300的工作效率并保证测试通量,会压缩加样件300的清洗时间,使得加样件300清洗不彻底,不能无法有效消除携带污染。
而该第二种液体分配方法至少存在如下有益效果,第一,由于加样件300吸取相同样本连续分配到至少两个反应器20中,在将相同样本连续分配至两个反应器20之间,加样件300无需再次伸入样本管430中吸取样本,也无需对加样件300进行清洗,故加样件300每隔至少两个反应器20才存在一次清洗的可能,有效避免传统方案中每隔仅一个反应器20即需清洗加样件300的现象。这样能减少加 样件300的清洗次数,从而提高加样件300的工作效率和免疫分析仪10的测试通量。第二,当加样件300在多次伸入样本管430中吸取相同样本之间,仅需对加样件300进行短时间清洗,这样可以使加样件300集中分配某一种相同样本后,再集中分配另一种相同样本,减少不同样本之间的切换频次,进一步起到减少加样件300清洗次数和清洗时间的作用。第三、由于减少了加样件300的清洗次数,在确保工作效率和测试通量的基础上,可以适当延长加样件300的每次清洗时间,以便对加样件300进行彻底的清洗,有效降低不同样本之间携带污染的风险。显然,清洗次数的减少也会减少清洗液的消耗,可以降低免疫分析仪10的测试成本。第四、在提高了加样效率和有效降低样本之间携带污染的基础上,使摆渡单元200和试剂分配件500协调高效运动,进一步提高了试剂的分配和反应物混匀的效率。在工作周期T内,通过试剂分配件500将试剂于第一工位31分配至每个已盛放有样本的反应器20中,并通过摆渡单元200对样本和试剂进行混匀处理,样本分配通过缓存单元完成,试剂分配和反应物混匀在摆渡单元上完成,提高了样本、试剂分配及反应物混匀的效率,从而提高了免疫分析仪的测试效率和通量,比如,本申请的免疫分析仪测试通量可以突破行业内目前报道的最高水平(600个测试每小时),实现720、800个测试每小时甚至更高的测试通量。
当采用上述液体分配装置11对反应器20中分配样本和稀释液(如前文所述,稀释液可以看成分析项目对应试剂的一个组分),并对样本和稀释液混匀以形成稀释样本,然后稀释样本分配至多个反应器20中,最后将试剂分配至盛放有稀释样本的反应器20并进行混匀处理,这样可以形成一种样本稀释方法。同时参阅图8和图11,该样本稀释方法主要包括如下步骤:
S810,将摆渡单元200承载已盛放有样本的第一反应器从初始工位30运动到第一工位31。
S820,向处于第一工位31处的第一反应器中分配稀释液。
S830,将第一反应器中的样本和稀释液混匀以形成稀释样本。
S840,将摆渡单元200承载盛放有稀释样本的第一反应器运动至第二工位32,将处于第二工位处的第一反应器中的稀释样本分配到至少二个空置的第二反应器中,当然,根据分析试项目的不同,向每个空置第二反应器中分配的稀释样本的量可能会存在不同,例如其中一个第二反应器中所分配的稀释样本的量可以大于另外一个第二反应器中所分配的稀释样本的量。
S850,将摆渡单元200承载分配有稀释样本的第二反应器运动到第一工位31,向处于第一工位31的第二反应器中分配试剂。
S860,对第二反应器中的稀释样本和试剂进行混匀处理。
在一些实施例中,参考上述第一种液体分配方法中的相关介绍,将第一反应器放置在缓存单元100上,通过加样件300在缓存单元100上的第一反应器中分配样本后,将盛放样本的第一反应器于初始工位30从缓存单元100移送至摆渡单元200上。换言之,样本均仅从缓存单元100上(并非从摆渡单元200上)分配至反应器20中,使得样本的分配不会受摆渡单元200运动速度和所处位置的限制,当摆渡单元200承载反应器20运动或静止的过程中,样本均能够从缓存单元100上(并非从摆渡单元200上)分配至反应器20中,从而提高免疫分析仪10的测试通量。
在一些实施例中,将空置的第二反应器放置在缓存单元100上,当稀释样本分配至第二反应器后,将盛放有稀释样本的第二反应器于初始工位30从缓存单元100移送至摆渡单元200上。对于第一反应器中样本和稀释液、及第二反应器中的稀释样本和试剂,均通过摆渡单元200本身对其进行混匀处理;混匀处理的方式为非接触偏心震荡处理。同时,将初始工位30设置在第一工位31和第二工位32之间,并使摆渡单元200在初始工位30、第一工位31和第二工位32之间做往复直线运动。
在一些实施例中,使缓存单元100在在接收工位33、加样工位34和移出工位35之间运动。第一反应器和第二反应器均从接收工位33进入至缓存单元100,样本从加样工位34分配至第一反应器中,稀释样本同样从加样工位34分配至第二反应器中,第一反应器和第二反应器两者均从移出工位35离开缓存单元100而移送至摆渡单元200上。当缓存单元100为转盘110时,转盘110带动第一、第二反应器在接收工位33、加样工位34和移出工位35之间做圆周运动。当缓存单元100为滑块120时,滑块120带动第一、第二反应器在接收工位33、加样工位34和移出工位35之间做直线运动。
对于传统的样本稀释方法,液体分配装置11每一次混匀形成的稀释样本只能供一个反应器20使用,即液体分配装置11对每一个反应器20均应单独进行一次混匀处理以形成稀释样本,换言之,一次混匀处理形成的稀释样本仅对应一个反应器20。这样增加了混匀形成稀释样本的处理次数,从而降低样本稀释的工作效率,进一步影响免疫分析仪10的最大测试通量。
而对于上述的样本稀释方法,液体分配装置11在第一反应器中将样本和稀释液混匀处理以形成稀释样本,并将第一反应器中的稀释样本分配到至少两个第二反应器中。因此,液体分配装置11每一次混匀形成的稀释样本能供至少两个反应器20使用,从而无需将液体分配装置11对每一个反应器20均单独进行一次混匀处理以形成稀释样本,换言之,一次混匀处理形成的稀释样本能对应至少两个反应器20,这样能大幅减少混匀形成稀释样本的处理次数,提高该样本稀释方法的工作效率,从而提高免疫分析仪10的最大测试通量。特别地,对于待检样本需要自动稀释后再进行测试的免疫分析项目,比如自身免疫疾病或过敏原检测等测试项目,常常需要样本稀释,且稀释样本需要进行多个测试,对于这类测试项目,该样本稀释方法有效解决了免疫分析仪10的最大测试通量瓶颈。
同时参阅图5和图12,当上述液体分配装置11的摆渡单元200的数量至少为两个时,可以形成第三种液体分配方法。当然,该第三种液体分配方法与第一种液体分配方法存在相似之处,即样本并非从摆动单元分配至反应器20中、而是从缓存单元100分配至反应器20中,当反应器20中分配样本后,移送单元将已盛放有样本的反应器20从缓存单元100移送至摆渡单元200。该第三种液体分配方法主要包括如下步骤:
S910,提供至少两个摆渡单元200,使各摆渡单元200在初始工位30和第一工位31之间往复运动。
S920,将已盛放有样本的反应器20于初始工位30移送至摆渡单元200上,事实上,样本从缓存单元100上分配至反应器20中,当样本分配至缓存单元100上的反应器20后,将盛放有样本的反应器20从缓存单元100移出并于初始工位30移入至摆渡单元200上。
S930,摆渡单元200带动从缓存单元100上输入并盛放有样本的反应器20从初始工位30运动到第一工位31,试剂于第一工位31处分配至反应器20中,然后对反应器20中的样本和试剂进行混匀处理。
S940,将摆渡单元200执行的动作序列可循环重现的最短时间窗口记为第一周期,用第一周期除以摆渡单元200数量所得的商值记为第二周期,从向其中一个摆渡单元200第一次移入反应器20时起,依次错开一个第二周期所间隔的时间先后向其它摆渡单元200上移入反应器20。
S950,依次错开一个第二周期所间隔的时间将混匀处理完毕的反应器20移出摆渡单元200,在移出反应器20的摆渡单元200上放入另外已盛放有样本的反应器20。
为使整个免疫分析仪10具有较高的测试通量,第二周期的长度可以为4-15秒内任何合适的值,比如4秒、4.5秒、5秒、6秒、9秒等,对应的测试通量为每小时900-240个测试,即免疫分析仪10每小时可以连续报告900-240个结果。为方便理解,下面以第二周期取5秒为例进行说明。
假如免疫分析仪10必须每隔5秒完成对一个反应器20的测量,即每隔5秒报告一个测试结果,此时,第二周期的时间为5秒。将整个免疫分析仪10看做流水线,必须保证流水线各处流量均相等,故摆渡单元200上同样必须每隔5秒输出一个已混匀处理完毕的反应器20。假如在只有一个摆渡单元200的情况下,由于摆渡单元200在一个周期内执行的移入已盛放有样本的反应器20、接受试剂分配件500分配试剂、偏心震荡混匀、移出已混匀完成的反应器20等动作序列所需要的时间总和大于5秒,摆渡单元200将无法每隔5秒输出一个已混匀处理完毕的反应器20,摆渡单元200的流量低于流水线的出口流量,导致流水线无法以最大效率(测试通量)连续工作。因此,通过将第一周期设置为第二周期的两倍,即第一周期为10秒,同时使得摆渡单元200的数量为两个,使两个摆渡单元200执行的动作序列相对错开第二周期的时间(即5秒)执行,即两个摆渡单元200相隔一个第二周期而“错开并行”。
工作时,按照摆渡单元200既有的运动规律,假如在第0秒于第一个摆渡单元200上移送已盛放有样本的反应器20,然后于第5秒向第二个摆渡单元200上移送已盛放有样本的反应器20。假定第一个摆渡单元200上的反应器20将于第10秒输出,在反应器20输出后,再向第一个摆动单元上移送已盛放有样本的反应器20。接着,第二个摆渡单元200上的反应器20将于第15秒输出,同样地,在反应器20输出后,再向第二个摆动单元上移送已盛放有样本的反应器20。按照上述的操作方式循环运作,将使得第一个摆渡单元200将于第10秒、第20秒、第30秒,……第10N秒输出一个反应器20;同时,第二个摆渡单元200将于第15秒、第25秒、第35秒,……第(5N+10)秒输出一个反应器20。因此,在每个摆渡单元200每隔10秒输出一个已混匀处理完毕的反应器20的基础上,两个摆渡单元200作为一个整体将每隔5秒输出一个已混匀处理完毕的反应器20,从而达到以“数量换时间”的目的,最终满足免疫分析仪10最高测试通量的要求。
当然,当第二周期仍然为5秒时,第一周期的时间还可以更长,此时使摆渡单元200的数量为三个、四个甚至更多,第一周期可以设置为第二周期的三倍、四倍甚至更多,即第一周期为15秒或20 秒等。这样在保证测试通量的基础上,可以减少摆渡单元200的运动速度,延长分配试剂以及样本与试剂的混匀时间,有效解决摆渡单元200的运动速度瓶颈、试剂分配以及样本、试剂的混匀时间瓶颈。在摆渡单元200的运动速度和样本、试剂的混匀时间一定的情况下,每个摆渡单元200仍然每隔10秒输出一个混匀处理完成的反应器20,即第一周期仍然为10秒。
在液体分配装置11的存储单元600数量与摆渡单元200数量相等的情况下,该第三种液体分配方法还包括如下步骤:
提供与摆渡单元200数量相等存储单元600,将试剂存放在每个存储单元600的多个存储部610上。
将存储部610跟随存储单元600运动到用于吸取试剂的吸液工位。
使每个存储单元600执行的动作序列可循环重现的最短时间窗口等于第一周期,从其中一个存储单元600第一次带动存储部610朝吸液工位运动时起,依次错开一个第二周期所间隔的时间先后使其它存储单元600带动存储部610朝相应的吸液工位运动。
参考上述对至少两个摆渡单元200相隔一个第二周期而“错开并行”的相关描述,通过使存储单元600数量与摆渡单元200数量相等,同时使存储单元600同样每相隔一个第二周期而“错开并行”。将所有存储单元600看成一个整体,每相隔一个第二周期的时间,均有其中一个存储单元600上的存储部610运动到吸液工位,以便试剂分配件500于该吸液工位吸取试剂。因此,对于单独的存储单元600来说,尽管每隔一个第一周期的时间带动存储部610运动到吸液工位,但是,当全部存储单元600看成一个整体时,每隔一个第二周期的时间将有存储部610抵达至吸液工位,这同样能达到以“数量换时间”的目的,最终满足免疫分析仪10最高测试通量的要求。
此外,对于传统的方案,存储单元600的数量通常为一个,为增加供分析项目使用的试剂的存储量,必须增加存储部610的数量,从而导致整个存储单元600的尺寸增大,存储单元600占用面积较大,不利于存储单元600的布局和生产制造,同时,对于体积和重量较大的存储单元600,也增加了对其运动控制的难度,导致存储部610无法在很短的时间内抵达指定位置以供试剂分配件500吸取试剂,成为实现高测试通量的一个瓶颈。同时,当存储单元600出现故障时,将导致整个免疫分析仪10无法工作。而该第三种液体分配方案通过设置至少两个存储单元600,每个存储单元600体积较小,有利于整机布局和运动控制,也能确保有较大的试剂存储量。同时,可以提高存储单元600对故障的容忍度,当其中一个存储单元600出现故障而无法工作时,其它剩余存储单元600可以继续工作,确保试剂能持续供应。当然,可以在其它存储单元600工作的同时,对出现故障的存储单元600进行整修。
在一些实施例中,提供与存储单元600数量相等的试剂分配件500,使得每个存储单元600对应一个试剂分配件500。这样可以提高试剂分配的效率,当然也可以在保证最大测试通量的基础上降低单个试剂分配件500的工作效率(负荷)。使每个试剂分配件500执行的动作序列可循环重现的最短时间窗口等于第一周期,从其中一个试剂分配件500分配试剂时起,依次错开一个第二周期所间隔的时间先后使其它试剂分配件500分配试剂。
参考上述对至少两个摆渡单元200和至少两个存储单元600相隔一个第二周期而“错开并行”的相关描述,通过使试剂分配件500与存储单元600数量、摆渡单元200数量相等,同时使试剂分配件500同样每相隔一个第二周期而“错开并行”。将所有试剂分配件500看成一个整体,每相隔一个第二周期的时间,均有其中一个试剂分配件500分配试剂。因此,对于单独的试剂分配件500来说,尽管每隔一个第一周期的时间向一个反应器20内分配试剂,但是,当全部存试剂分配件500看成一个整体时,每隔一个第二周期的时间将有试剂分配件500分配一次试剂,这同样能达到以“数量换时间”的目的,最终满足免疫分析仪10最高测试通量的要求。
当摆动单元在初始工位30和第一工位31之间做直线运动时,可以将存储单元600平分为数量相等的两半,其中一半存储单元600与另一半存储单元600相对摆渡单元200的运动轨迹对称,这样有利于免疫分析仪10整机的布局。
因此,通过将已盛放有样本的反应器20于初始工位30移送至摆渡单元200上,即样本从缓存单元100事先分配至反应器20中,省去了从摆渡单元200向反应器20中分配样本的时间,从而降低了反应器20在每个摆渡单元200上的停留时间,使每个摆渡单元200能快速输出一个反应器20。同时,将摆渡单元200设置为至少两个,至少两个摆渡单元200相隔一个第二周期而“错开并行”,尽管单个 摆渡单元200每间隔一个第一周期输出一个反应器20,但全部摆渡单元200作为一个整体将每隔一个时间较短的第二周期输出一个反应器20,这样能够达到以“数量换时间”的目的,最终满足免疫分析仪10最高测试通量的要求。
在一些实施例中,该第三种液体分配方法与第二种液体分配方法存在相似之处,即通过加样件300吸取相同样本连续分配到缓存单元100上的至少两个反应器20中,同时,在吸取相同样本连续分配到至少两个反应器后,将加样件300进行清洗或更换,其有益效果可以参考对上述第二种液体分配方法的描述。
同样地,在分配样本的过程中,使加样件300采用样本针或一次性吸嘴,在吸取相同样本连续分配到至少两个反应器后,对样本针的内壁、外壁进行清洗或对一次性吸嘴进行更换。为清洗彻底,对样本针进行清洗的时间为2秒至10秒。当加样件300的容量大于各反应器20所需相同样本的总量时,加样件300仅吸取一次并连续分多次将相同样本分配至不同的反应器20中。
参见图13,以相同样本(第一S)测试四个分析项目为例进行说明。加样件300吸一次相同样本(第一S)并连续分4次将分成四份(分别记为S1、S2、S3、S4)的第一S分配到四个反应器中。由于加样件300下一次吸取的样本为不同样本,分配S1、S2、S3、S4到四个反应器完成后,对加样件300的样本针的内壁、外壁进行清洗或对一次性吸嘴进行更换。
对于加样件300吸一次连续分配的四个反应器,每个试剂分配件500按第一周期分配对应分析项目的试剂到位于第一工位处的摆渡单元200上的已分配第一S的反应器内,两个试剂分配件500之间相隔N个第二周期分配对应分析项目的试剂到位于第一工位处31的摆渡位上的摆渡单元200上的已分配第一S的反应器内。具体地,第一试剂分配件500在第1第一周期T向含有S1的第一反应器20内分配试剂,在第2第一周期T向含有S3的第三反应器20内分配试剂,第二试剂分配件500在第2第一周期T向含有S2的第二反应器20内分配试剂,在第3第一周期T向含有S4的第四反应器20内分配试剂,可见,第一试剂分配件500和第二试剂分配件500之间相隔N个第二周期(T/2)分配对应分析项目的试剂。这样可以保证每个第二周期(T/2)都有一个反应器20完成试剂的分配,从而提升了试剂的分配效率。总之,对于分配同一样本后的至少两个反应器,每个试剂分配件500依次错开一个第二周期(T/2)按N(N为整数且N≥1)个第一周期间隔分配分析项目的试剂。
本申请的第三种液体分配方法,在提高了样本分配效率和有效降低样本之间携带污染的基础上,使至少2个摆渡单元200、至少两个存储单元600、至少2个试剂分配件500高效协调运动,进一步提高了试剂的分配和反应物混匀的效率,从而提高了免疫分析仪的测试效率和通量,比如,本申请的免疫分析仪测试通量可以突破行业内目前报道的最高水平(600个测试每小时),实现720、800个测试每小时甚至更高的测试通量。
本申请还提供一种免疫分析方法,该免疫分析方法包括上述第一种液体分配方法、第二种液体分配方法、第三种液体分配方法和样本稀释方法中的步骤。
以上所述实施例的各技术特征可以进行任意的组合,为使描述简洁,未对上述实施例中的各个技术特征所有可能的组合都进行描述,然而,只要这些技术特征的组合不存在矛盾,都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本申请的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本申请构思的前提下,还可以做出若干变形和改进,这些都属于本申请的保护范围。因此,本申请专利的保护范围应以所附权利要求为准。

Claims (20)

  1. 一种液体分配装置,其特征在于,包括:
    缓存单元,能够接收并带动反应器运动,所述缓存单元上的反应器用于分配样本;及
    摆渡单元,靠近所述缓存单元设置,所述摆渡单元能够带动从所述缓存单元上输入已分配样本的反应器做直线运动,所述摆渡单元上的已分配样本的反应器用于分配试剂,所述摆渡单元对分配试剂后的反应器中的反应物混匀;
    其中,在摆渡单元承载已分配样本的反应器运动或静止的过程中,样本能够同时分配至缓存单元上空置的反应器中。
  2. 根据权利要求1所述的液体分配装置,其特征在于,具有初始工位和第一工位,所述摆渡单元能够在初始工位和第一工位之间往复运动,其中,来自缓存单元的反应器从初始工位输入至摆渡单元上,试剂于第一工位分配至反应器中。
  3. 根据权利要求1所述的液体分配装置,其特征在于,还包括机架、传送器、支座和驱动器,所述传送器安装在所述机架上,所述支座滑动设置在所述机架上并与所述传送器连接,所述摆渡单元和驱动器均设置在所述支座上,所述驱动器能够使所述摆渡单元产生偏心震荡,所述摆渡单元上设置有用于插置反应器的收容孔。
  4. 根据权利要求3所述的液体分配装置,其特征在于,所述传送器包括电机、主动轮、从动轮和同步带,所述电机用于驱动所述主动轮转动,所述同步带缠绕在所述主动轮和从动轮上;当电机转动时,主动轮和从动轮带动同步带移动,同步带驱动支座运动。
  5. 根据权利要求3所述的液体分配装置,其特征在于,所述传送器为丝杆机构或齿轮齿条。
  6. 根据权利要求3所述的液体分配装置,其特征在于,所述机架上设置有滑轨,所述支座与所述滑轨配合。
  7. 根据权利要求1所述的液体分配装置,其特征在于,具有接收工位、加样工位和移出工位,所述缓存单元能够承载反应器在所述接收工位、加样工位和移出工位之间运动;其中,所述缓存单元在接收工位承载空置的反应器,样本于加样工位分配至空置的反应器中,已分配样本的反应器于移出工位脱离缓存单元并移送至摆渡单元。
  8. 根据权利要求7所述的液体分配装置,其特征在于,所述缓存单元包括能够绕自身中心轴线转动的转盘,所述转盘上设置有用于固定反应器的多个缓存位,所述缓存位沿所述转盘的周向间隔分布,每个缓存位能够在接收工位、加样工位和移出工位之间运动。
  9. 根据权利要求8所述的液体分配装置,其特征在于,所述缓存位沿所述转盘的周向间隔排列而形成至少一个缓存圈,至少一个缓存圈均环绕所述转盘的中心轴线同心设置,其中一个缓存圈靠近所述转盘的边缘设置。
  10. 根据权利要求9所述的液体分配装置,其特征在于,至少一个缓存圈包括一个缓存圈。
  11. 根据权利要求7所述的液体分配装置,其特征在于,所述缓存单元包括能够做直线运动的滑块,所述滑块上设置有用于固定反应器的多个缓存位,所述缓存位在所述滑块上呈矩阵式分布,每个所述缓存位能够在接收工位、加样工位和移出工位之间运动。
  12. 根据权利要求7所述的液体分配装置,其特征在于,所述缓存单元包括均设置有缓存位的转盘和滑块,所述转盘上的缓存位沿所述转盘的周向间隔排列,所述滑块上的缓存位在所述滑块上排列成直线,所述滑块能够在加样工位和移出工位之间做直线运动;其中,空置反应器从接收工位进入转盘上的缓存位,空置反应器跟随转盘转动设定角度后被移送至滑块。
  13. 根据权利要求8至12中任一项所述的液体分配装置,其特征在于,所述缓存位均为容置孔。
  14. 根据权利要求1所述的液体分配装置,其特征在于,还包括样本输送单元,所述样本输送单元包括样本架、样本管和输送轨道,所述样本架与所述输送轨道配合,所述样本管放置在样本架上并用于盛放样本。
  15. 根据权利要求14所述的液体分配装置,其特征在于,还包括用于吸取所述样本管中样本的加样件,所述加样件为样本针。
  16. 根据权利要求15所述的液体分配装置,其特征在于,所述样本针呈细长状的圆柱形。
  17. 根据权利要求14所述的液体分配装置,其特征在于,还包括用于吸取吸取所述样本管中样本的加样件,所述加样件为一次性吸嘴。
  18. 根据权利要求1所述的液体分配装置,其特征在于,还包括存储单元,所述存储单元为可转动的圆盘,所述存储单元上设置有多个用于存储试剂的存储部。
  19. 根据权利要求18所述的液体分配装置,其特征在于,所述存储部的数量为15-50个。
  20. 一种免疫分析仪,其特征在于,包括权利要求1至19中任一项所述的液体分配装置。
PCT/CN2019/082173 2019-02-02 2019-04-11 液体分配装置和免疫分析仪 WO2020155387A1 (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201910107416.6 2019-02-02
CN201910107416.6A CN111521771B (zh) 2019-02-02 2019-02-02 液体分配装置和免疫分析仪

Publications (1)

Publication Number Publication Date
WO2020155387A1 true WO2020155387A1 (zh) 2020-08-06

Family

ID=71841544

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2019/082173 WO2020155387A1 (zh) 2019-02-02 2019-04-11 液体分配装置和免疫分析仪

Country Status (2)

Country Link
CN (1) CN111521771B (zh)
WO (1) WO2020155387A1 (zh)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140170636A1 (en) * 2012-12-19 2014-06-19 Roche Diagnostics Operations, Inc. Device and method for transferring reaction vessels
CN104714042A (zh) * 2013-12-16 2015-06-17 深圳市亚辉龙生物科技有限公司 一种全自动化学发光免疫分析仪及其使用方法
CN106645765A (zh) * 2017-01-06 2017-05-10 刘丹 自动分析装置及样本分析方法
CN108459168A (zh) * 2018-03-27 2018-08-28 深圳市科创志达技术有限公司 一种全自动化学发光免疫分析仪
CN207866831U (zh) * 2017-08-16 2018-09-14 北京普利生仪器有限公司 血液分析仪
CN208420505U (zh) * 2018-06-26 2019-01-22 深圳迎凯生物科技有限公司 混匀装置

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102116771B (zh) * 2010-01-04 2013-12-04 深圳市亚辉龙生物科技有限公司 一种全自动酶联免疫分析仪
CN102147406B (zh) * 2011-02-14 2013-08-28 四川迈克生物科技股份有限公司 全自动化学发光免疫分析仪
CN103592450B (zh) * 2013-11-28 2015-03-11 博奥赛斯(天津)生物科技有限公司 全自动化学发光免疫分析仪
WO2016002394A1 (ja) * 2014-07-02 2016-01-07 株式会社 日立ハイテクノロジーズ 血液凝固検査装置
CN108061810A (zh) * 2017-12-14 2018-05-22 江苏锐汗德医疗科技有限公司 一种全自动管式时间分辨免疫分析仪
CN207866716U (zh) * 2017-12-28 2018-09-14 深圳市新产业生物医学工程股份有限公司 化学发光检测仪
CN207866714U (zh) * 2017-12-28 2018-09-14 深圳市新产业生物医学工程股份有限公司 化学发光检测仪
CN207866715U (zh) * 2017-12-28 2018-09-14 深圳市新产业生物医学工程股份有限公司 化学发光检测仪

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140170636A1 (en) * 2012-12-19 2014-06-19 Roche Diagnostics Operations, Inc. Device and method for transferring reaction vessels
CN104714042A (zh) * 2013-12-16 2015-06-17 深圳市亚辉龙生物科技有限公司 一种全自动化学发光免疫分析仪及其使用方法
CN106645765A (zh) * 2017-01-06 2017-05-10 刘丹 自动分析装置及样本分析方法
CN207866831U (zh) * 2017-08-16 2018-09-14 北京普利生仪器有限公司 血液分析仪
CN108459168A (zh) * 2018-03-27 2018-08-28 深圳市科创志达技术有限公司 一种全自动化学发光免疫分析仪
CN208420505U (zh) * 2018-06-26 2019-01-22 深圳迎凯生物科技有限公司 混匀装置

Also Published As

Publication number Publication date
CN111521771A (zh) 2020-08-11
CN111521771B (zh) 2021-08-27

Similar Documents

Publication Publication Date Title
WO2020155385A1 (zh) 液体分配方法和免疫分析方法
WO2020155389A1 (zh) 样本稀释方法和免疫分析方法
WO2020155388A1 (zh) 液体分配方法和免疫分析方法
WO2020155387A1 (zh) 液体分配装置和免疫分析仪
WO2020155386A1 (zh) 液体分配方法和免疫分析方法
WO2020087238A1 (zh) 反应装置和免疫分析仪
CN111122888B (zh) 混匀方法、混匀装置及免疫分析仪
CN111122894B (zh) 试剂吸取方法、试剂供给装置及免疫分析仪
CN111122886B (zh) 稀释方法、稀释装置及免疫分析仪
WO2020087256A1 (zh) 试剂吸取方法、试剂供给装置及免疫分析仪
WO2020087255A1 (zh) 稀释方法、稀释装置及免疫分析仪
WO2020087251A1 (zh) 免疫分析仪
WO2020087244A1 (zh) 混匀方法、混匀装置及免疫分析仪
WO2020087240A1 (zh) 混匀方法、混匀装置及免疫分析仪
WO2020087245A1 (zh) 免疫分析方法
WO2020087252A1 (zh) 反应装置和免疫分析仪
CN111122889A (zh) 免疫分析方法
CN111122887B (zh) 混匀方法、混匀装置及免疫分析仪
CN111122885B (zh) 免疫分析仪

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 19914060

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 19914060

Country of ref document: EP

Kind code of ref document: A1