WO2020087238A1 - 反应装置和免疫分析仪 - Google Patents

反应装置和免疫分析仪 Download PDF

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Publication number
WO2020087238A1
WO2020087238A1 PCT/CN2018/112534 CN2018112534W WO2020087238A1 WO 2020087238 A1 WO2020087238 A1 WO 2020087238A1 CN 2018112534 W CN2018112534 W CN 2018112534W WO 2020087238 A1 WO2020087238 A1 WO 2020087238A1
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Prior art keywords
reactor
mixing
station
reagent
cleaning
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PCT/CN2018/112534
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English (en)
French (fr)
Inventor
张震
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深圳迎凯生物科技有限公司
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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
Priority to PCT/CN2018/112534 priority Critical patent/WO2020087238A1/zh
Priority to EP18938386.2A priority patent/EP3875960B1/en
Publication of WO2020087238A1 publication Critical patent/WO2020087238A1/zh

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/0098—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor involving analyte bound to insoluble magnetic carrier, e.g. using magnetic separation
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02—Automatic 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
    • G01N35/025—Automatic 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 having a carousel or turntable for reaction cells or cuvettes
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N2035/00346—Heating or cooling arrangements
    • G01N2035/00356—Holding samples at elevated temperature (incubation)

Definitions

  • the invention relates to the technical field of in vitro diagnosis, in particular to a reaction device and an immune analyzer.
  • the full-automatic immunoassay analyzer can quantitatively or qualitatively detect the target analytical substances such as antibodies and antigens contained in the blood waiting test sample.
  • the empty reactor is filled with the test sample and reagents (or reactants) and mixed After the steps of homogenization, incubation and washing separation (Bound-free, combined separation, ie BF separation, sometimes referred to as washing in this article), the signal reagent is added to the reactor to measure the optical or electrical signal, so as to achieve the Measurement analysis including target analytes.
  • the entire immunoassay analyzer has a defect that the structure is not compact enough.
  • a reaction device capable of improving the compactness of the structure.
  • a reaction device including:
  • a rotating disk the rotating disk is used for incubating, cleaning and measuring the reactants in the reactor;
  • a cleaning assembly located above the rotating disk and capable of injecting cleaning liquid and extracting waste liquid into the reactor, the cleaning assembly includes a signal injection reagent portion for injecting a signal reagent into the reactor after cleaning and separation;
  • the signal reagent mixing unit is used for mixing the signal reagent to the reactor after the signal reagent is added;
  • a measuring device connected to the rotating disk to measure the optical signal of the reactant in the reactor after the signal reagent is added;
  • the transfer component can transfer the reactor between the rotating disk and the signal reagent mixing unit.
  • An immune analyzer includes any of the above reaction devices.
  • FIG. 1 is a schematic plan view of the immune analyzer provided in the first embodiment
  • FIG. 2 is a schematic diagram of the three-dimensional structure of the mixing device in FIG. 1;
  • FIG. 3 is a schematic plan view of the immune analyzer provided in the second embodiment
  • FIG. 4 is a schematic diagram of the three-dimensional structure of the mixing device in FIG. 3;
  • FIG. 5 is a flowchart of a serial mixing method provided by an embodiment
  • FIG. 6 is a flow block diagram of a parallel mixing method provided by an embodiment
  • FIG. 7 is a flow block diagram of a reagent extraction method provided by an embodiment
  • FIG. 8 is a flow block diagram of a dilution method provided by an embodiment
  • FIG. 9 is a flowchart of an immunoassay method provided by an embodiment.
  • Sample reagent (or reactant) incubation refers to the process of antigen-antibody binding reaction or biotin avidin binding reaction of the reactants in the constant temperature environment before the reactor starts to be washed (washed and separated).
  • the reagents and analysis items mentioned here have a "one-to-one correspondence" relationship, that is, the specific reagents corresponding to different analysis items generally differ in terms of formula, amount of reagents, and number of components.
  • the reagent usually includes multiple components, such as the common 2-5 components, including magnetic particles, enzyme labels, diluent, dissociation reagent and other reagent components, such as T4 reagent (thyroxine, thyroid Element) contains three components: magnetic particles, enzyme label and dissociation agent.
  • T4 reagent thyroxine, thyroid Element
  • multiple reagent components of an analysis item can be distributed at one time or in multiple steps.
  • the reagents are defined as the first reagent, the second reagent, and the third reagent according to the distribution order. After the incubation is completed, washing and separation is carried out.
  • Cleaning and separation refers to capturing the complex of bound magnetic particles, antigen and labeled antibody with a magnetic field, and at the same time removing free (free) labeled antibody and other unreacted or bound components (this article is an expression) Convenient, referred to as unbound ingredients) process.
  • the signal reagent is distributed, signal incubation is carried out (usually 1-6 minutes), and finally the amount of luminescence generated by the reaction of the labeling reagent and the signal reagent is measured (this is convenient for expression, and is called a reactant signal).
  • the signal reagent is used to generate a measurement signal (usually the amount of luminescence), and is usually a kind of general-purpose reagent, and the corresponding relationship between the analysis items is "one-to-many", that is, different analysis items share the signal reagent.
  • Signal incubation refers to the process of cleaning and separating the reactor after adding the signal reagent and reacting for a period of time under a constant temperature environment to enhance the signal. It should be pointed out that due to the different specific components of the signal reagent, some luminescent systems do not require signal incubation, and can be directly measured during the process of distributing the signal reagent or after the signal reagent is dispensed.
  • the signal reagent may be one or more, for example, some signal reagents include a first signal reagent, a second signal reagent, and the like.
  • the immunoassay device after the above process, the antigen or antibody contained in the sample bound to the labeling reagent is quantitatively or qualitatively determined.
  • the immunoanalyzer can analyze the sample according to several different analysis items.
  • Work cycle or cycle is the shortest time window that can be reproduced in the test process. It usually has a fixed length of time. Within the cycle time, a certain number of process operations, tasks, or work packages, such as taking fluid , Mixing, incubation, cleaning and separation, measurement and other operations and tasks, in serial or parallel execution in a controlled sequence. The tasks of the same component in a cycle are usually executed serially. The tasks of different components in the same cycle depend on whether the actions of related components are dependent on each other, and can be executed in series or in parallel. All process operations performed in one cycle are only performed when needed, and are not necessarily repeated in another cycle. In particular, some process operations may occur repeatedly in each cycle, while others may occur every two or more cycles.
  • test is usually completed in multiple cycles, where the different process operations used to perform the test occur in different cycles.
  • the working cycle of different components may not be the same, that is, there may be multiple parallel cycles in the same system
  • there is a multiple relationship between the length of multiple cycles in parallel and the multiple is usually equal to the number of the same component.
  • N N ⁇ 2, a natural number
  • each reagent pipetting unit works in the first cycle.
  • the length of the first cycle is N times that of the second cycle, and the sequence of actions of the N reagent units is continuously "staggered in parallel" for the second cycle.
  • the invention can realize high-throughput immunoassay.
  • the typical second cycle length is 4-15 seconds, and the corresponding test flux is 900-240 tests per hour, that is, 900-240 results can be reported continuously per hour.
  • an immunoanalyzer 10 provided by an embodiment of the present invention includes a mixing device 100, a reaction device 200, a reagent supply device 300, a sample supply device 410, and a reactor supply device 420.
  • the reactor supply device 420 is used to provide a clean and empty reactor 20
  • the sample supply device 410 is used to add a sample to the empty reactor 20
  • the reagent supply device 300 is used to add a sample to the reactor 20 containing the sample
  • the reagent and mixing device 100 is used for mixing and processing the reactor 20 containing the sample and the reagent
  • the reaction device 200 is used for incubating, cleaning and measuring the sample and the reagent after the mixing and processing in the reactor 20.
  • the reactor supply device 420 includes a supply silo, a sorting mechanism, a supply chute, and a supply tray.
  • the supply silo is used to store the clean and empty reactor 20.
  • the supply silo can be located behind the reagent supply device 300, so that the whole space can be fully utilized, and the structure of the immunoassay analyzer 10 becomes more compact.
  • the supply chute introduces the sorted reactors 20 to the supply tray one by one, and the supply tray is used to buffer the reactor 20 supplied by the chute and the reactor 20 It can be arranged at intervals along the circumferential direction of the supply tray.
  • the supply tray can rotate around its own central axis to drive the reactor 20 to a specified position, which can be defined as the reactor supply station.
  • the reactor 20 on the supply tray will be The reactor supply station is transferred to the mixing device 100.
  • the sample supply device 410 includes a sample rack, a sample tube, a transport rail, a sample pipetting unit 411, and the like.
  • the sample rack can be matched with the conveying rail, the sample tube is placed on the sample rack, and the sample tube is used to hold the sample. For example, about five to ten sample tubes can be placed on each sample rack.
  • the sample pipetting unit 411 sucks and samples the sample from the tube, and adds the sample to the empty reactor 20.
  • the sample pipetting unit 411 may use a steel needle or a disposable suction nozzle. In order to achieve a smooth aspiration of the sample, the sample pipetting unit 411 may perform vertical up and down movements, horizontal linear movements or horizontal rotations.
  • the mixing device 100 is a tandem type, the series mixing device 101 includes a transport component 110 and a mixing component 120, at least two mixing components are provided on the transport component 110 120.
  • the transport component 110 can drive all the mixing components 120 to move synchronously in the same direction. In short, all the mixing components 120 are connected in series on one transport component 110.
  • the transportation assembly 110 includes a rack 111 and a conveyor disposed on the rack 111.
  • the conveyor is used to drive all the mixing components 120 to move synchronously in the same direction, and may be composed of one or more transmission forms or mechanisms such as a synchronous belt, a screw drive, and a rack and pinion.
  • the conveyor includes a motor 113, a driving wheel 114 and a driven wheel 115, and a timing belt 112.
  • the motor 113 is used to drive the driving wheel 114 to rotate.
  • the timing belt 112 is wound around the driving wheel 114 and the driven wheel 115. When 113 rotates, the driving wheel 114 and the driven wheel 115 drive the timing belt 112 to move.
  • Each mixing assembly 120 includes a support 121, a drive 123, and a carrying platform 122.
  • the support 121 is slidably disposed on the rack 111 and connected to the conveyor of the transport assembly 110.
  • the rack 111 may be provided with a slide rail
  • the support 121 cooperates with the slide rail
  • the timing belt 112 drives the bracket to slide in the direction in which the slide rail extends
  • the driver 123 is installed on the support 121 and connected to the bearing platform 122, which carries the platform 122 is used to place the reactor 20, and the timing belt 112 can drive the support 121 on each mixing assembly 120 to move in the same direction
  • the drive 123 can drive the bearing platform 122 to generate eccentric oscillations, so that the reactants in the reactor 20 Mixing is achieved due to non-contact eccentric shock.
  • At least two accommodating holes 122a may be provided on the carrying platform 122, and the reactor 20 is inserted into the accommodating holes 122a, so as to realize the carrying effect of the carrying platform 122 on the reactor 20.
  • the receiving hole 122a can also be replaced by a solid structure such as a bracket, as long as the reactor 20 can be placed on the carrying platform 122.
  • one of the mixing components 120 includes a first support 1211 and a first carrying platform 1221, and the other mixing component 120 includes a second support 1212 and a second supporting platform 1222,
  • the first support 1211 has a first mounting end 1211a
  • the second support 1212 has a second mounting end 1212a
  • the second mounting end 1212a is disposed near the first mounting end 1211a.
  • the first carrier 1221 is located at the first mounting end 1211a
  • the second carrier 1222 is located at the second mounting end 1212a.
  • the first carrier 1221 and the second carrier 1222 are oppositely arranged, which facilitates the sample and reagent The designated location is added to the reactor 20 on different carriers 122.
  • the series-type mixing method mainly includes the following steps:
  • S520 Add a sample to the reactor 20 at the first station 11, add a reagent to the reactor 20 at the second station 12, and mix the sample and the reagent in the reactor 20 with a uniform treatment.
  • the synchronous belt 112 drives the carrier 122 to move to the first station 11, the synchronous belt 112 stops moving. Since the sample pipetting unit 411 is disposed near the first station 11, the sample pipetting unit 411 will aspirate the sample and add it to it A reactor 20; after the sample is added, the timing belt 112 drives the carrier 122 to move to the second station 12, the timing belt 112 stops moving, and the reagent can be added to the reagent pipetting unit 310 in the reagent supply device 300 to The reactor 20 containing the sample. After the sample and the reagent are added to the reactor 20, the driver 123 can drive the carrying platform 122 to generate eccentric vibration, so as to mix the sample and the reagent in the reactor 20 by non-contact eccentric vibration.
  • the action sequence or task performed by the mixing component 120 includes moving into the reactor 20, accepting the sample pipetting unit 411 to add the sample, accepting the reagent pipetting unit 310 to add the reagent, eccentrically shaking, and removing the reactor 20 after the mixing is completed
  • the shortest time window that can be reproduced repeatedly is recorded as the first period, that is, the minimum time interval for the mixing component 120 to perform the same action twice in succession is the first period.
  • the value obtained by dividing the first cycle by the number of mixing components 120 is recorded as the second cycle. From the time when one of the mixing modules 120 is moved into the reactor 20 for the first time, the time interval of a second cycle is shifted into each of the other mixing modules 120 into the reactor 20 in sequence.
  • the working cycle of the transport component 110 is the second cycle
  • the working cycle of the mixing component 120 is the first cycle.
  • the transport assembly 110 can synchronously drive the mixing assembly 120 to cyclically reciprocate between the first station 11 and the second station 12 during each second cycle.
  • the reactor 20 that has been mixed is shifted out of the mixing module 120 by a time interval of a second cycle, and then moved into the new reactor 20 on the mixing module 120 that has been removed from the reactor 20.
  • the invention can realize high-throughput immune test.
  • the length of the second cycle can be any suitable value within 4-15 seconds, such as 4 seconds, 5 seconds, 6 seconds, 9 seconds, etc., and the corresponding test flux is per hour 900-240 tests, that is, 900-240 results can be reported continuously every hour.
  • the following uses the transport component 110 to drive the two mixing components 120 to move synchronously as an example. If the immunoassay analyzer 10 must complete the measurement of one reactor 20 every 10 seconds, that is, report a test result every 10 seconds, at this time The time of the second cycle is 10 seconds. Considering the entire immunoassay analyzer 10 as a pipeline, it must be ensured that the flow rates in the pipeline are equal, so the mixing device 100 must also output a reactor 20 that has been mixed and processed every 10 seconds.
  • the sample receiving pipetting unit 411 adds the sample
  • the reagent pipetting unit 310 adds the reagent
  • the eccentric shaking mixes The total time required to move out of the mixed reactor 20 and other action sequences is greater than 10 seconds, the mixing device 100 will not be able to output a mixed reactor 20 every 10 seconds, and the flow rate of the mixing device 100
  • the outlet flow rate below the assembly line prevents the assembly line from working continuously with maximum efficiency. Therefore, by setting the first cycle to twice the second cycle, that is, the first cycle is 20 seconds, and the number of mixing components 120 is two, the sequence of actions performed by the two mixing components 120 is relatively staggered.
  • the initial station 13 can also be set, so that the transport assembly 110 drives the mixing assembly 120 to cyclically reciprocate between the initial station 13, the first station 11 and the second station 12; at the initial station 13, the reaction The mixer 20 is moved into or out of the mixing assembly 120.
  • the initial station 13, the first station 11 and the second station 12 may be arranged on the same straight line, and the initial station 13 is between the first station 11 and the second station 12, so that the mixing assembly 120 is The movement trajectory between the initial station 13, the first station 11 and the second station 12 is a straight line.
  • the initial station 13, the first station 11 and the second station 12 may also be set on the same circumference, so that the mixing assembly 120 is made between the initial station 13, the first station 11 and the second station 12 Circular motion.
  • the transport unit 110 drives the mixing unit 120 to circulate and reciprocate between multiple stations, so that the mixing unit 120 can complete different methods in different stations in an orderly manner.
  • the sequence of actions reduces the movement stroke of the sample pipetting unit 411, reagent pipetting unit 310 and other units, and can achieve more flexible and efficient task operations for the reactor 20, such as receiving the reactor 20, receiving samples, reagents and mixing tasks , So as to improve the test throughput of the whole machine.
  • a reactor 20 is added to the first carrier 1221 for the first time at the initial station 13, and at this time, no reaction is added to the second carrier 1222 20;
  • the conveyor drives the first carrier 1221 and the second carrier 1222 to move from the initial station 13 to the first station 11, adding samples to the reactor 20 on the first carrier 1221;
  • the conveyor drives the first The carrier 1221 and the second carrier 1222 move from the first station 11 to the second station 12 to add reagents to the reactor 20 containing the sample on the first carrier 1221;
  • the first carrier 1221 generates eccentric shock , So that the sample and the reagent in the reactor 20 start to mix;
  • the conveyor drives the first carrier 1221 and the second carrier 1222 to return from the second station 12 to the initial station 13, at this time, the first carrier 1221 And the second carrier 1222 arrive at the initial station 13 at the 10th second, and the reactor 20 is added to the second carrier 1221 for the first time;
  • the conveyor drives the first carrier 1221 and the second carrier 1222 from the initial station 13 Move
  • the reactor 20 when the first carrier 1221 and the second carrier 1222 reach the initial station 13 at the 20th second, the reactor 20 is added to the second carrier 1222 for the second time.
  • the reactor 20 will move into the mixing device 100 .
  • each mixing component 120 is every 20 seconds A mixing reactor 20 is completed and removed from the mixing device 100 to the reaction device 200, but the entire mixing device 100 will output a reactor 20 after the mixing process is completed, so that the mixing device 100
  • the flow rate is equal to the outlet flow rate of the pipeline.
  • the mixing time is fully utilized, and the sample or reagent is added to the reactor 20 on the other mixing module 120, so that the entire mixing The flow rate of the device 100 meets the requirements of the test flux.
  • the time of the first cycle can be longer.
  • the number of mixing components 120 is three, four or more, and the first cycle can be set as the second cycle Three times, four times or more, that is, the first cycle is 30 seconds or 40 seconds, etc.
  • the movement speed of the transport component 110 can be reduced, the mixing time of the sample and the reagent can be prolonged, and the bottleneck of the motion speed of the transport component 110 and the mixing time of the sample and the reagent can be effectively solved.
  • each mixing component 120 still outputs a reactor 20 after 20 seconds for the completion of the mixing process, that is, the first cycle is still 20 seconds
  • the test throughput of the immunoassay analyzer 10 needs to be increased, for example, a measured reactor 20 is required to be output every 5 seconds (second cycle), the mixing unit 120 on the transport unit 110 can be increased to four ; If it is required to output a measured reactor 20 every 4 seconds (second cycle), the mixing module 120 on the transport module 110 can be increased to five.
  • At least two mixing positions may be provided in each mixing assembly 120.
  • the mixing position is the receiving hole 122a on the carrying platform 122.
  • the mixing positions When one of the mixing positions (the receiving hole 122a) is being mixed or the mixing is completed
  • the reactor 20 is moved into other idle mixing positions (accommodation holes 122a) on the mixing assembly 120. This can solve the problem of mixing and occupancy of the reactor 20 in the process of moving in and out on the same carrier 122, and improve the test efficiency and test throughput.
  • the mixing process of the sample and the reagent in the reactor 20 may be performed after the movement of the mixing unit 120 driven by the transport component 110 stops, or may be performed during the motion, for example, when the mixing component 120 is moved from the second station 12 During the process of returning to the initial station 13, the driver 123 causes the carrier 122 to eccentrically oscillate to mix the sample and the reagent. Performing the mixing process during the movement can make full use of the time during the movement of the mixing unit 120 to mix the sample and the reagents, to ensure that the mixing device 100 meets the test flux requirements.
  • the time required for the reactor 20 loaded with samples and reagents to start from the beginning of mixing to the completion of mixing is usually 2-10 seconds, the working cycle of the transport component 110 is the first cycle, and the two mixing components 120 are the second cycle, so that There is enough time for the sample and reagent to mix well, to ensure that the sample and reagent can produce a sufficient reaction, and improve the accuracy of the subsequent measurement results.
  • the mixing device 100 is a parallel type
  • the parallel mixing device 102 includes at least two mixing mechanisms 103
  • each mixing mechanism 103 includes a transport assembly 110 and mixing
  • the mixing assembly 120 is arranged on the transport assembly 110, and the transport assembly 110 drives the mixing assembly 120 to move.
  • each mixing mechanism 103 includes a transport assembly 110 and a mixing assembly 120
  • the strokes of the mixing assemblies 120 are parallel to each other.
  • each transport assembly 110 includes a rack 111 and a conveyor provided on the rack 111
  • each mixing assembly 120 includes a support 121, a driver 123, and a bearing platform 122, and details are not described herein again.
  • the main difference from the series mixing device 100 is that the mixing components 120 are respectively disposed on different transport components 110, and the motions of the mixing components 120 on the different transport components 110 are not synchronized.
  • At least one mixing mechanism 103 includes one transport assembly 110 and at least two mixing assemblies 120, the transport assembly 110 drives the at least two mixing assemblies 120 to move synchronously, and at this time, the mixing mechanism 103 At least two mixing components 120 on the series are connected in series with each other.
  • the mixing component 120 on the mixing mechanism 103 and the mixing components 120 on the other mixing mechanism 103 are parallel to each other, that is, the mixing component 120 in the entire mixing device 100 There are both parallel and series (ie hybrid) relationships.
  • the parallel mixing method mainly includes the following steps:
  • each transport component 110 is provided with a mixing component 120 for carrying the reactor 20, and each transport component 110 drives the mixing component 120 at the first station 11 and the second station Cycle back and forth between 12.
  • S620 Add a sample to the reactor 20 at the first station 11, add a reagent to the reactor 20 at the second station 12, and mix the sample and the reagent in the reactor 20 with a uniform treatment.
  • the action sequence or task performed by the mixing component 120 includes moving into the reactor 20, accepting the sample pipetting unit 411 to add the sample, accepting the reagent pipetting unit 310 to add the reagent, eccentrically shaking, and removing the reactor 20 after the mixing
  • the shortest time window that can be reproduced repeatedly is recorded as the first period, that is, the minimum time interval for the mixing component 120 to perform the same action twice in succession is the first period.
  • the value obtained by dividing the first cycle by the number of mixing components 120 is recorded as the second cycle. From the time when the mixing module 120 on one of the transport modules 110 is moved into the reactor 20 for the first time, the time between the second cycle is staggered to move to the mixing module 120 on the other transport modules 110 into the reactor 20 . It can be understood that, in order to achieve the above steps, the working cycle of each transportation component 110 and mixing component 120 is the second cycle.
  • the reactor 20 that has been mixed is shifted out of the mixing unit 120 by a time interval of a second cycle, and a new reactor 20 is placed on the mixing unit 120 that has been removed from the reactor 20.
  • the number of the transport components 110 is two, and each transport component 110 is provided with a mixing component 120 as an example for description.
  • the second cycle is 10 seconds
  • each mixing mechanism 103 outputs a reactor 20 that has been mixed every 20 seconds, that is, the first cycle is 20 seconds, because the time interval between a second cycle is staggered in sequence ( 10 seconds) successively move into the reactor 20 on the mixing unit 120 of the other transport components 110, and finally the entire mixing device 100 will output a reactor 20 that has been mixed and processed every 10 seconds. Quantity for time ".
  • the initial station 13 can also be set, so that the transport assembly 110 drives the mixing assembly 120 at the initial station 13, the first station 11 and the second The reciprocating movement between the stations 12; at the initial station 13, the reactor 20 is moved into or out of the mixing unit 120.
  • the initial station 13, the first station 11 and the second station 12 may be arranged on the same straight line, and the initial station 13 is between the first station 11 and the second station 12, so that the mixing assembly 120 is The movement trajectory between the initial station 13, the first station 11 and the second station 12 is a straight line.
  • the transport unit 110 drives the mixing unit 120 to cyclically reciprocate between multiple stations, which improves the test throughput of the whole machine.
  • Each mixing unit 120 is provided with at least two mixing positions.
  • the mixing position is the accommodating hole 122a on the carrying platform 122.
  • the two mixing positions are used simultaneously or alternately, which can improve the mixing unit 120 to the reactor 20. Processing efficiency.
  • the reactor 20 can be moved to another mixing position (accommodating hole 122a) on the mixing assembly 120.
  • the sample and the reagent in the reactor 20 can be mixed during the movement of the transport component 110 driving the mixing component 120 or after the motion is stopped, that is, the mixing of the sample and the reagent in the reactor 20 is not subject to the transport component
  • the limitation of 110 motion states can make the mixing device 100 more flexible and efficient.
  • one of the transport components 110 is denoted as the first transport component 1101, and the other transport component 110 is denoted as the second transport component 1102.
  • the first transport component 110 is denoted as the first transport component 1101
  • a reactor 20 is added to the carrier 122 on the first transport assembly 1101 for the first time.
  • the carrier 122 on the second transport assembly 1102 is not added to the reactor 20.
  • the first transport assembly 110 when it moves from the initial station 13 to the first station 11, a sample is added to the reactor 20 on the carrier 122 of the first transport assembly 1101; the first transport assembly 1101 starts from the first station Position 11 moves to the second station 12, and the reagent is added to the reactor 20 containing the sample on the carrying platform 122 of the first transport component 1101; the carrying platform 122 of the first transport component 1101 generates an eccentric shock, causing the reactor 20 The sample and reagent in the mixture begin to mix.
  • the reactor 20 is first added to the carrier 122 on the second transport assembly 1102 , And make the second transportation component 1102 start to move according to the movement rule of the first transportation component 1101.
  • the carrier 122 on the first transport component 1102 and the carrier 122 on the second transport component 1102 reach the initial station 13 at the 20th, 30th, and 10n seconds, the reactor 20 will move in To the mixing device 100.
  • each mixing component 120 is every 20 seconds A mixing reactor 20 is completed and removed from the mixing device 100 to the reaction device 200, but the entire mixing device 100 will output a reactor 20 with the mixing process completed every 10 seconds.
  • the transport assembly 110 drives the mixing assembly 120 to be separated by a second period (10 seconds) and "staggered in parallel", although each mixing mechanism 103 outputs a mixed period of 20 seconds (first period).
  • the transport assembly 110 can move at a slower speed, which solves the movement speed bottleneck and samples of the transport assembly 110, Bottleneck of mixing time between reagents.
  • the transport component 110 drives all the mixing components 120 disposed thereon to move synchronously, that is, the at least one mixing mechanism 103 includes at least one Two mixing components 120, the mixing components 120 on the mixing mechanism 103 are in a series relationship, therefore, the mixing components 120 on the entire mixing device 100 have a parallel and a serial relationship at the same time, similarly, each mixing The module 120 is added to the reactor 20 for the first time at a second cycle interval, and finally the entire mixing device 100 outputs a reactor 20 that has been mixed and processed at a second cycle interval.
  • the partial mixing components 120 By arranging the partial mixing components 120 in series, the structure of the entire mixing device 100 can be made more compact.
  • the reagent supply device 300 is disposed near the second station 12, the reagent supply device 300 includes a reagent pipetting unit 310 and a storage unit 320, the number of the storage unit 320 is at least two ,
  • the storage unit 320 is provided with a plurality of storage parts 321, the storage part 321 is used for placing and storing reagent containers, the reagents are contained in the reagent containers, and the reagent pipetting unit 310 is used for sucking the reagents in the reagent containers on the storage part 321 Components, and the reagent components are added to the reactor 20 at the second station 12.
  • the number of storage units 321 can be set according to needs.
  • the number of storage units 321 on each storage unit 320 is preferably 15-50, such as the storage units on each storage unit 320 The number of 321 is 25, so that two storage units 320 can store 50 reagent containers online at the same time.
  • Each storage unit 320 stores all the reagent components required for the corresponding analysis item. For example, in an analysis item, three reagent components, magnetic particles, enzyme label and dissociation agent, must be added to the reactor 20. The three components of granules, enzyme label and dissociation agent are placed on the same storage unit 320. When an analysis project needs to load multiple reagent containers to expand the on-board test volume of the project, the multiple reagent containers can be stored in each storage unit in any suitable combination.
  • TSH thyroid stimulating hormone
  • the number of storage sections 321 must be increased, resulting in an increase in the size of the entire storage unit 320, which occupies a large area, which is not conducive to the layout of the storage unit 320
  • manufacturing on the other hand, for the storage unit 320 with a larger volume and weight, it also increases the difficulty of controlling its movement, resulting in the storage unit 321 unable to reach the designated position in a short time for the reagent pipetting unit 310 Pipetting reagents has become a bottleneck in achieving high test throughput.
  • the conventional reagent supply device 300 places multiple reagent components for the same analysis item on different storage units 320, not only makes the reagent pipetting unit 310 draw the same analysis item on multiple different storage units 320 Reagents, which leads to a large stroke and complex motion logic of the reagent pipetting unit 310, which cannot achieve high test throughput. It also requires reagent components to be contained in multiple reagent containers, resulting in problems such as high manufacturing costs and inconvenience for users. In addition, Because multiple reagent components of the same analysis item are placed on different storage units 320, when a storage unit fails and does not work, it will directly cause the instrument to fail to continue testing.
  • the reagent supply device 300 of the above embodiment is provided with at least two storage units 320, and each storage unit 320 has a small volume, which is conducive to the layout and motion control of the whole machine, and can also ensure that the entire reagent supply device 300 has a large reagent storage capacity .
  • each storage unit 320 stores all the reagent components required for the corresponding analysis item, which can improve the reliability and tolerance of the reagent supply device 300.
  • the storage unit 320 can continue to work to ensure that the reagent supply device 300 can still work effectively.
  • the faulty storage unit 320 may be repaired.
  • the storage unit 320 may be a rotating disk, and the rotating disk periodically rotates intermittently to drive the storage unit 321 to a designated position (ie, the pipetting station 14), so that the reagent pipetting unit 310 sucks the storage unit 321 at the pipetting station 14 Of reagents.
  • the number of reagent pipetting units 310 may be equal to the number of rotating disks, each rotating disk corresponds to a reagent pipetting unit 310, and each reagent pipetting unit 310 draws reagents from the rotating disk corresponding to it. Similar to the sample pipetting unit 411, the reagent pipetting unit 310 can use a steel needle or a disposable suction nozzle.
  • the reagent pipetting unit 310 can perform vertical up and down movement, horizontal linear movement or horizontal rotation And other forms of exercise.
  • the number of the reagent pipetting unit 310 may also be one, and the one reagent pipetting unit 310 sucks reagents in a plurality of rotating disks.
  • the reagent supply device 300 further includes a scanner.
  • the scanner is provided on the storage unit 320.
  • the scanner can recognize the barcode information of the reagent container on the storage unit 321, so as to distinguish different reagents.
  • the scanner is fixedly installed.
  • the storage unit 320 may further be provided with a refrigerator, and the refrigerator may perform cold storage processing on the reagent in the storage unit 321, thereby realizing long-term online storage of the reagent.
  • a method for aspirating the reagent when the reagent supply device 300 is used to aspirate the reagent, a method for aspirating the reagent may be formed.
  • the method for aspirating mainly includes the following steps:
  • a reagent pipetting unit 310 and at least two storage units 320 for storing reagents are provided, and the reagent containers are stored on a plurality of storage parts 321 of the storage unit 320, so that each storage unit 320 stores the necessary analysis items All reagent components.
  • the storage unit 321 is moved along with the storage unit 320, so that the reagent pipetting unit 310 sucks the reagent from the storage unit 321 that has arrived at the liquid suction station 14.
  • the movement of the storage unit 320 may be rotation.
  • the storage unit 320 periodically rotates intermittently, so that the storage unit 321 arrives at the liquid suction station 14 every set time, so that the reagent pipetting unit 310 draws the reagent.
  • the shortest time window in which the sequence of actions performed by each storage unit 320 is cyclically reproducible is recorded as the first cycle, that is, the minimum time interval for the storage unit 320 to perform the same action twice in succession is the first cycle.
  • the value obtained by dividing the first cycle by the number of memory cells 320 is recorded as the second cycle. Since one of the storage units 320 drives the storage unit 321 to the liquid suction station 14 for the first time, the time interval of a second cycle is staggered successively so that the other storage units 320 drive the storage unit 321 toward the corresponding liquid suction station 14 Movement.
  • the value of the second cycle is equal to the value of the second cycle mentioned in the above mixing method, and the same is carried out with 10 seconds as an example. It means that a storage unit 321 arrives at the aspiration station 14 every 10 seconds for the reagent pipetting unit 310 to aspirate the reagent.
  • the value of the first period is also equal to the value of the first period mentioned in the above mixing method, that is, the value of the first period is 20 seconds.
  • the two storage units 320 are "staggered in parallel" by being separated by a second cycle, although each storage unit 320 will have a storage unit 321 arriving at the corresponding pipetting station 14 every 20 seconds
  • the sequence of actions of the two storage units 320 is staggered by 10 seconds to start execution, so that the entire reagent supply device 300 will have a storage unit 321 every 10 seconds to reach the pipetting station 14 for the reagent pipetting unit 310 to draw reagents,
  • the number of storage units 320 is increased in exchange for time.
  • the storage unit 320 can be rotated at a slower speed, thereby solving the movement speed bottleneck of the storage unit.
  • the flow rate of the entire reagent supply device 300 can be increased under the condition that the rotation speed of the storage unit 320 is unchanged, thereby improving the test flux of the immunoassay analyzer 10.
  • the movement speed of the storage unit 320 does not become a bottleneck for the throughput of the immunoassay analyzer when multiple storage units
  • the action sequence of 320 can be "synchronized serial", that is, the action sequence of multiple storage units 320 during the working cycle is synchronized, and serialized during the working cycle, each storage unit 320 can store the target storage unit in each working cycle 321 is positioned to the pipetting station 14 for the reagent pipetting unit 310 to draw reagents, but only one storage unit 320 is required per working cycle to locate the target storage part 321 to the pipetting station 14 for the reagent pipetting unit 310 to draw reagents .
  • the two storage units 320 (respectively referred to as the first storage unit and the second storage unit) and the working period of 10 seconds are taken as an example for description.
  • a storage part 321 of the first storage unit arrives at the pipetting station 14 for the reagent pipetting unit 310 to aspirate the reagent;
  • a storage part 321 of the second storage unit reaches the aspirate liquid Station 14 for the reagent pipetting unit 310 to draw the reagent;
  • the third 10 seconds a storage part 321 of the first storage unit reaches the pipetting station 14 for the reagent pipetting unit 310 to draw the reagent; according to this rule, each In 10 seconds, two storage units 320 are alternately serially connected during the week, and one storage unit 321 arrives at the liquid suction station 14 for the reagent pipetting unit 310 to absorb the reagent.
  • the first storage unit positions the storage unit 321 to the pipetting station 14 for the reagent pipetting unit 310 to draw the reagent; the Nth , (N + 1),... (N + M) th 10 seconds (M ⁇ 1), the second storage unit positions the storage part 321 to the pipetting station 14 for the reagent pipetting unit 310 to absorb the reagent.
  • one of the storage units can locate the storage unit 321 to the liquid suction station 14 for the reagent pipetting unit 310 to absorb the reagent.
  • the reagent pipetting unit 310 can quickly absorb the reagents and increase the flow rate of the reagent supply device 300 to supply the reagents.
  • the instrument can use other storage units 320 to continue testing, without affecting the normal test of the instrument and improving the tolerance to failure.
  • all the reagent components required for a test corresponding to the analysis item are placed in the same storage unit 320, and can be contained in a reagent container containing multiple reagent chambers, which not only saves manufacturing costs, but also facilitates user loading and unloading operations.
  • At least one cavity of the reagent container on the storage unit 321 (such as a magnetic particle cavity containing magnetic particle reagent components) rotates around its own central axis In order to vortex the magnetic particle reagent components in the form of solid suspension, to avoid precipitation of solid substances (such as magnetic particles) therein.
  • the plurality of storage units 320 are independently provided, that is, each storage unit 320 can independently rotate to position the reagent on the storage unit 321 to the liquid suction station 14.
  • the "independent setting" here has nothing to do with the spatial layout and physical location between the storage units 320, for example, multiple storage units 320 can be distributed on the instrument without overlapping, or one of the storage units 320 can be embedded It fits around or inside the other storage unit 320.
  • the plurality of storage units 320 are preferably of the same structure and separated in layout.
  • the multiple storage units 320 are independently provided, which can increase the flexibility of control, further improve the efficiency of reagent supply, and thus increase the processing throughput of the instrument.
  • the number of reagent pipetting units 310 and the storage units 320 may be equal, and each storage unit 320 corresponds to a reagent pipetting unit 310, that is, each storage unit 320 draws reagents from the reagent pipetting unit 310 corresponding thereto.
  • each storage unit 320 draws reagents from the reagent pipetting unit 310 corresponding thereto.
  • the reaction device 200 includes a rotating disk 210, a transfer assembly 220, a measuring instrument 230, and a cleaning assembly 250.
  • the rotating disk 210 is provided with an incubation circle 203, a cleaning circle 202 and a measuring circle 201.
  • the incubation circle 203, the cleaning circle 202 and the measurement circle 201 are all set around the rotation center of the rotating disk 210, and the incubation circle 203 is provided with an incubation position 213 to incubate
  • the bit 213 is arranged along the circumferential interval of the incubation circle 203;
  • the cleaning circle 202 is provided with a cleaning position 212, and the cleaning position 212 is arranged along the circumferential interval of the cleaning circle 202;
  • the measurement circle 201 is provided with a measurement position 211, and the measurement position 211 is measured along
  • the circumferential intervals of the circles 201 are set.
  • the incubation position 213, the cleaning position 212, and the measurement position 211 are all used to place the reactor 20, and the three may be suitable structures for carrying the reactor 20, such as slots or brackets.
  • the measuring instrument 230 is connected to the rotating disk 210, and the measuring instrument 230 can measure the optical signal of the reactor 20 after the signal reagent is added, so as to realize further analysis of the reactants.
  • the cleaning assembly 250 is located above the cleaning ring 202 and includes a liquid injection part and a liquid suction part. The liquid injection part injects the cleaning buffer into the reactor 20 on the cleaning position 212, and the liquid suction part can be lowered and raised into and out of the cleaning position 212 The reactor 20 is pumped to remove unbound components in the reactor 20.
  • the cleaning assembly 250 further includes a signal injection reagent portion for injecting the signal reagent into the reactor 20 on the cleaning position 212 after cleaning and separation.
  • the reaction device 200 further includes a waste liquid absorption component 240 and a signal reagent mixing unit 430.
  • the waste liquid absorption component 240 is located above the measuring circle 201.
  • the waste liquid absorption component 240 can be lowered and raised into and out of the reactor 20 on the measurement position 211, and the waste liquid in the reactor 20 (mainly Signal reagent) suction, and finally the reactor 20 after the suction of the waste liquid is transferred to the discarding station, so as to realize the separation treatment of solid waste and liquid waste, and reduce the risk of biological hazards.
  • the waste liquid absorption assembly 240 may be connected to the liquid absorption portion of the cleaning assembly 250, and together with the liquid absorption portion of the cleaning assembly 250, may be lowered to the bottom of the reactor to absorb liquid, and then lifted off the reactor after the absorption is completed.
  • the signal reagent mixing unit 430 is provided independently of the rotating disk 210, and includes a mixing component similar to or the same as the foregoing mixing component 120, and performs eccentric vibration mixing on the reactor 20 containing the signal reagent.
  • the transfer assembly 220 removes the mixed reactor 20 from the mixing device 100 and moves it to the incubation position 213. During the rotation of the rotating plate 210, the incubation position 213 mixes the reactor 20 with the reactor 20. Incubate the sample and reagent after homogenization for a set time. After the incubation of the reactor 20 is completed, the transfer assembly 220 transfers the reactor 20 from the incubation position 213 to the cleaning position 212.
  • the liquid injection portion of the cleaning assembly 250 can be in the cleaning position 212
  • the reactor 20 in the first injection of cleaning fluid, and then the magnetic particle compound is adsorbed on the inner wall of the reactor 20 by a magnetic field, the liquid absorption portion of the cleaning assembly 250 then extracts unbound components from the reactor 20, after multiple rounds of " After the injection of the cleaning liquid—adsorption—extraction of unbound components ”, the reactants of the reactor 20 complete the cleaning and separation.
  • the signal injection reagent part can add the signal reagent to the reactor 20, and the transfer component 220 transfers the reactor 20 to which the signal reagent is added from the cleaning position 212 to the signal reagent mixing unit 430 through The signal reagent mixing unit 430 mixes it.
  • the mixing time of the signal reagent is 2-6 seconds.
  • the measuring position 211 incubates the reactor 20 for a set time.
  • the measuring instrument 230 pairs the reactor 20.
  • the reactant signal is measured in order to analyze the reactants.
  • the three of the incubation circle 203, the cleaning circle 202 and the measurement circle 201 are arranged concentrically, that is, the three of them all take the rotation center of the rotating disk 210 as the center of the circle.
  • the incubation circle 203, the cleaning circle 202 and the measurement circle 201 are arranged in order from the inside to the outer periphery around the center of rotation, that is, the measurement circle 201 is close to the edge of the rotating disk 210, the incubation circle 203 is close to the center of the rotating disk 210, and the cleaning circle 202 is provided in the incubation circle 203 And measuring circle 201.
  • the number of incubation circles 203 is at least two, for example, 2-10 Among them, the incubation circle 203 that is closest to the rotation center is recorded as the inner incubation circle, and the incubation circle 203 that is farthest from the rotation center is recorded as the outer incubation circle. According to the needs of cleaning efficiency, the number of cleaning circles 202 is set to 1-2. The number of measuring circles 201 is one, which can meet the needs of measurement.
  • the reaction device 200 is provided with an incubation station 15, a cleaning station 16, a cleaning station 17 and a measurement station 18.
  • the number of incubation in and out stations 15 is not less than the number of incubation circles 203, and the cleaning in and out stations 16 and 17
  • the number is equal to the number of the cleaning circles 202 respectively, and the number of the measuring and entering stations 18 is not less than the number of the measuring circles 201, that is, at least one.
  • the cleaning-in station 16 and the cleaning-out station 17 are respectively provided at the rotation center of the rotating disk 210
  • the two sides of the cleaning ring 202 are located at both ends of the diameter of the cleaning ring 202.
  • the in- and out-station 15 is on the same side as the cleaning-in station 16 and the measuring-in and out-station 18 is on the same side as the cleaning-out station 17. In this way, the reactor removed from the incubation station 15 can be moved from the cleaning station 16 into the cleaning circle 202, and the reactor removed from the station 17 can be moved from the measurement station 18 into the measurement circle 201.
  • the transfer assembly 220 moves the reactor 20 on the mixing device 100 from the incubation entry and exit station 15 to the incubation position 213, when the reactor 20 follows the rotating disk 210 to incubation in and out At station 15, the transfer assembly 220 moves the reactor 20 from the incubation station 15 to the incubation station 213, and from the cleaning station 16 to the cleaning station 212; when the reactor 20 follows the rotating disc 210 to the cleaning station At 17 o'clock, the transfer component 220 moves the reactor 20 from the cleaning out station 17 out of the cleaning station 212 and into the signal reagent mixing unit 430 to perform signal reagent mixing.
  • the reactor 20 moves from the measurement in and out station 18 into the measurement position 211;
  • the reactor 20 moves to the position of the measuring device 230 following the rotating disc 210, after the measuring device 230 measures the reaction signal, the reactor 20 continues to follow the rotating disc 210 to the position of the waste liquid absorbing component 240, and the liquid absorbing liquid component 240 will The waste liquid in the reactor 20 is completely sucked out. After the waste liquid is sucked, the reactor 20 continues to follow the rotary disk 210 to the measurement entry and exit station 18.
  • the transfer assembly 220 completes the measurement at the measurement entry and exit station 18 After suction removal of the waste reactor 20 the measuring site 211 and into discard station.
  • the transfer assembly 220 can move the reactor 20 from the in- and out-of-incubation station 15 out of the incubation station 213, and from the cleaning out of the station 17 out of the cleaning station
  • the reactor 20 at 212 is moved into the mixing device 100.
  • the movement trajectory of the transfer component 220 between the initial station 13, the in-and-out station 15, the cleaning-in station 16, the cleaning-out station 17 and the measuring-in and out station 18 is a straight line, which passes through the orthographic projection of the rotating disk 210 The rotation center of the rotating disk 210. In this way, the movement of the transfer assembly 220 can be simplified, and the working efficiency of the transfer assembly 220 can be improved to meet the requirements of the test flux.
  • the straight line where the movement trajectory of the transfer component 220 also passes through the signal reagent mixing unit 430, and the transfer component 220 can transfer the reactor 20 between the signal reagent mixing unit 430, the measuring circle 201, and the cleaning circle 202.
  • the number of transfer assemblies 220 can be set to two, and a relay station 214, relay station is provided in the inner incubation circle (closest to the rotation center) of the rotating disc 210 214 is used to temporarily carry the reactor 20.
  • the movement trajectory of one of the transfer components 220 forms a first projection on the rotating disk 210
  • the movement trajectory of the other transfer component 220 forms a second projection on the rotating disk 210.
  • the first projection and the second projection are connected in the same straight line at the relay station 214. It is recorded as a trajectory straight line; a straight line passing through the relay station 214 and perpendicular to the trajectory straight line is used as a reference straight line.
  • One of the transfer components 220 is responsible for the transfer of the reactor 20 located on the right side of the reference line, and the other transfer component 220 is responsible for the transfer of the reactor 20 located on the left side of the reference line.
  • the transfer component 220 moves the reactor 20 from the cleaning out station 17 to the cleaning position 212 and into the mixing unit 120 to add the second reagent, the reactor 20 needs to be moved from the reference straight line
  • the left part of the reactor is transferred to the right part.
  • the reactor 20 can be transferred from the cleaning position 212 of the left part of the reference line to the relay station through a transfer component 220, and then the reactor 20 can be transferred from the relay station through another transfer component 220. Then transfer to the mixing unit 120 on the right part of the reference straight line.
  • the relay station 214 is disposed at the center of rotation of the rotating disk 210.
  • the transport component 110, the mixing component 120, the sample pipetting unit 411, and the reagent pipetting unit 310 can be combined to form a dilution device, that is, the The dilution device includes a transport assembly 110, a mixing assembly 120, and a pipetting assembly, the pipetting assembly includes a sample pipetting unit 411 and a reagent pipetting unit 310, of course, the transport assembly 110, mixing assembly 120, sample pipetting unit 411 and The structure and position of the reagent pipetting unit 310 can be kept unchanged. Similar to the mixing device 100 described above, the dilution device can also be provided with an initial station 13, a first station 11 and a second station 12, of course, the initial station 13 can also be omitted.
  • the mixing assembly 120 is disposed on the transport assembly 110.
  • the mixing assembly 120 can simultaneously carry at least two reactors 20. Taking two reactors 20 as an example, one reactor 20 is denoted as the first reactor and the other one The reactor 20 is referred to as the second reactor.
  • the mixing assembly 120 is provided with at least two receiving holes 122a, and the first reactor and the second reactor can be placed in different receiving holes 122a, respectively.
  • the transport assembly 110 drives the mixing assembly 120 to move between the initial station 13, the first station 11, and the second station 12.
  • the first reactor is transferred from the supply tray to the mixing assembly 120 through the transfer assembly 220; when the mixing assembly 120 moves to the first At station 11, the sample is transferred to the first reactor through the sample pipetting unit 411; when the mixing unit 120 moves to the second station 12, the dilution liquid is drawn into the first reactor through the reagent pipetting unit 310 And mix the sample and the diluent to form a diluted sample; when the mixing unit 120 returns to the initial station 13 again, the transfer unit 220 moves up the mixing unit 120 into the second reactor; when the mixing unit 120 again When moving to the first station 11, a part of the diluted sample is transferred from the first reactor to the second reactor through the sample pipetting unit 411.
  • the mixing unit 120 moves to the second station 12
  • the reagent is passed
  • the pipetting unit 310 absorbs the reagent component and adds it to the second reactor containing the diluted sample, and mixes the diluted sample and the reagent component.
  • the mixing component 120 finally moves to the initial station 13, it is transferred by Component 220 will Two reactor into the reaction apparatus 200 of the incubation 213.
  • the first reactor can be moved to the discarding station and discarded.
  • the dilution device can continuously output the reactor 20 in which the diluted sample and the reagent components have been mixed and processed to achieve automatic dilution of the sample.
  • the number of mixing components 120 is at least two. Each mixing component 120 can realize automatic dilution of the sample, and the mixing components 120 can be implemented in parallel or in series. Automatic dilution of samples. Similar to the aforementioned serial mixing device, the same transport component 110 synchronously drives the mixing component 120 to cyclically reciprocate between the first station 11 and the second station 12; similar to the aforementioned parallel mixing device, it is provided with at least Two transport assemblies 110, each transport assembly 110 is provided with a mixing assembly 120 for carrying the reactor 20, and each transport assembly 110 drives the mixing assembly 120 to circulate back and forth between the first station 11 and the second station 12 motion.
  • the dilution method mainly includes the following steps:
  • S840 Move a second reactor to the mixing unit 120 and move to the first station 11 again, and add a part of the diluted sample in the first reactor 20 to the second reactor;
  • each mixing component 120 can be used in turn in the above-mentioned dilution step.
  • the first mixing component is used when the first sample is automatically diluted
  • the second mixing component is used when the second sample is diluted
  • the first mixing component is used when the third sample is automatically diluted ...
  • both the diluent and the reagent components are placed on the same storage unit 320.
  • the first reactor is moved out of the mixing unit 120 and discarded to the discarding station.
  • the remaining diluted sample in the first reactor can be first Aspirate, and then discard the first reactor formed after all the diluted samples are absorbed.
  • the mixing unit 120 is circulated back and forth between the initial station 13, the first station 11 and the second station 12. At the initial station 13, the first 1.
  • the second reactor 20 is moved into or out of the mixing unit 120.
  • the initial station 13, the first station 11 and the second station 12 are arranged on the same straight line, so that the initial station 13 is between the first station 11 and the second station 12.
  • the mixing assembly 120 mixes it by non-contact eccentric shaking.
  • the dilution device of the present invention integrates the mixing assembly 120, which can move between different stations to complete the automatic dilution and mixing of the sample, avoiding the dilution of the pipetting unit at a fixed station, and then the reactor Transferring to another station for mixing improves the efficiency and effect of dilution and mixing, and solves the problem of high-throughput bottlenecks in which the automatic dilution of samples limits the immunoassay.
  • an immunoassay method can be formed.
  • the immunoassay method mainly includes the following steps:
  • S910 providing at least two mixing components 120 for carrying the reactor 20, so that the mixing component 120 drives the reactor 20 to reciprocate between the first station 11 and the second station 12.
  • the shortest time window in which the action sequence or task performed by the mixing component 120 can be reproduced cyclically is recorded as the first cycle, that is, the minimum time interval for the mixing component 120 to perform the same action twice in succession is the first cycle.
  • the value obtained by dividing the cycle by the number of mixing components 120 is recorded as the second cycle. From the time when one of the mixing modules 120 is moved into the reactor 20 for the first time, the time interval of a second cycle is shifted into each of the other mixing modules 120 into the reactor 20 in sequence.
  • the reactor 20 that has been mixed is shifted out of the mixing assembly 120 by a time interval of a second cycle, and then moved into the new reactor 20 on the mixing assembly 120 that has been removed from the reactor 20.
  • the reactor 20 which is removed from the mixing unit 120 and contains the reactants is sequentially incubated, washed, separated and measured.
  • the incubation time of the reactor 20 is 5-60 minutes.
  • the second period is equal to the time interval between consecutively outputting two measured reactors 20 from the reaction device 200, that is, the time interval between two consecutive test results reported by the immune analyzer 10 continuously.
  • step S940 When performing reaction mode tests of other methods, such as delayed one-step method and two-step method test, in the above step S940, the reactor 20 after incubation or cleaning can be moved to the mixing device again according to the steps of S920 and S930 Add the second reagent to 100 and mix. After the mixing is completed, incubate, wash, separate and measure according to step S940.
  • the incubation in step S940 may further include the following first incubation and second incubation:
  • the reactor 20 containing the sample and the first reagent is incubated for a set time.
  • a second reagent is added to the reactor 20 after the first incubation, and then incubated for a set time.
  • the reactor 20 after the first incubation is moved to the mixing device 100 again according to the steps of S920 and S930, the second reagent is added and mixed, and mixed After completion, the second incubation, cleaning, separation and measurement are performed according to step S940.
  • the immunoassay method further includes the following steps:
  • the second incubated reactor 20 is subjected to a second cleaning.
  • the reactor 20 undergoes the steps S910, S920, and S930, the reactor 20 is first subjected to the first incubation through the reaction device 200, and then the first incubated reactor 20 is subjected to the first cleaning through the reaction device 200, After the first cleaning, the reactor 20 is moved into the mixing device 100 again according to the steps of S920 and S930, and the second reagent is added and mixed. After the mixing is completed, the step S940 is followed to perform the incubation, the second cleaning and the measurement.
  • the same transport component 110 drives all the mixing components 120 to move synchronously, that is, the sample and the reagent in the reactor 20 are mixed using the above-mentioned series-type mixing method.
  • the number of the transport components 110 is plural, and each transport component 110 drives at least one mixing component 120 to move, that is, the sample and the reagent in the reactor 20 are mixed by the above-mentioned parallel mixing method.
  • the transport assembly 110 can drive the mixing assembly 120 to cyclically reciprocate between the initial station 13, the first station 11 and the second station 12; at the initial station 13 At this time, the reactor 20 is moved into or out of the mixing unit 120, the sample is added to the reactor 20 at the first station 11, and the reagent is added to the reactor 20 at the second station 12.
  • the reactor 20 can be incubated from the incubation station 15 into the incubation station 213 on the rotating disk 210 for incubation, and the reactor 20 can be moved from the cleaning station 16 into the rotating disk 210
  • the cleaning station 212 performs cleaning and separation, and moves the reactor 20 from the cleaning out station 17 to the cleaning station 212 after the cleaning and separation is completed, and moves the reactor 20 from the measurement in and out station 18 into the measurement station 211 on the rotating disk 210 Carry out the measurement; make the movement trajectory of the transfer assembly 220 between the incubation in and out station 15, the cleaning in and out station 16, the cleaning and out in station 17 and the measurement in and out station 18 on the same straight line.
  • a relay station 214 is provided in the inner incubation circle of the rotating disk 210 (closest to the center of rotation).
  • a relay station 214 for temporarily carrying the reactor 20 is provided at the center of rotation, and the number of transfer assemblies 220 is set to two.
  • the movement trajectory of one transfer component 220 forms a first projection on the rotating disk 210
  • the movement trajectory of another transfer component 220 forms a second projection on the rotating disk 210, so that the first projection and the second projection are at the relay station 214 Connected in a straight line.
  • the incubation position 213, the washing separation and measurement position 211 are set on the same rotating disk 210.
  • the waste liquid in the reactor 20 is sucked first, and then the reactor 20 after the waste liquid is sucked is discarded.
  • the reagent pipetting unit 310 sucks the reagent from the storage unit 320 into the reactor 20, and the sucking of the reagent includes the following sub-steps:
  • a reagent pipetting unit 310 and at least two storage units 320 for storing reagents are provided, and the reagents are contained in reagent containers on the plurality of storage sections 321 of the storage unit 320.
  • the storage unit 321 follows the storage unit 320 to move the reagent pipetting unit 310 into the reagent container on the storage unit 321 arriving at the liquid suction station 14 to aspirate the reagent.
  • the shortest time window in which the sequence of actions or tasks performed by each storage unit 320 can be reproduced cyclically is equal to the first cycle, that is, the minimum time interval between two consecutive executions of the same action by the storage unit 320 is equal to the first cycle. From the time when one of the storage units 320 drives the reagent to the liquid suction station 14 for the first time, the time interval between the second cycle is staggered successively so that the other storage units 320 drive the reagent to the corresponding liquid suction station 14.
  • the reagent extraction includes the following sub-steps:
  • a reagent pipetting unit 310 and at least two storage units 320 for storing reagents are provided, and the reagents are contained in reagent containers on the plurality of storage sections 321 of the storage unit 320.
  • the storage unit 321 follows the storage unit 320 to move the reagent pipetting unit 310 into the reagent container on the storage unit 321 arriving at the liquid suction station 14 to aspirate the reagent.
  • Synchronize the sequence of actions of multiple storage units 320 that is, synchronize the sequence of actions of multiple storage units 320 during the work cycle, serialize during the work cycle, and each storage unit 320 can target
  • the storage unit 321 is positioned to the pipetting station 14 for the reagent pipetting unit 310 to draw reagents, but only one storage unit 320 is required per working cycle to locate the target storage unit 321 to the pipetting station 14 for the reagent pipetting unit 310 Pipette reagents. In short, in any working cycle, one of the storage units positions the storage unit 321 to the liquid suction station 14 for the reagent pipetting unit 310 to absorb the reagent.
  • each storage unit 320 corresponds to one reagent pipetting unit 310 respectively.
  • the workflow on the immunoassay analyzer 10 is as follows: First, the empty and clean reactor 20 is placed at the initial station 13 from the supply tray through the transfer assembly 220 Second, the transport assembly 110 drives the mixing assembly 120 to move to the first station 11, the sample pipetting unit 411 adds samples to the reactor 20 located at the first station 11; third, The transport assembly 110 drives the mixing assembly 120 to move to the second station 12, the reagent pipetting unit 310 adds reagents to the reactor 20 at the second station 12, and the mixing assembly 120 causes the samples and reagents in the reactor 20 Mixing; fourth, the transfer assembly 220 moves the mixed reactor 20 from the mixing assembly 120 to the incubation position 213 of the rotating disk 210 after being incubated in and out of the station 15; fifth, after the incubation is completed, the transfer assembly 220 will react The incubator 20 moves it out of the incubation station 213 at the incubation station 15 and from the cleaning station 16 to the cleaning station 212 of the rotating disc
  • the transfer assembly 220 transfers the reactor after the signal reagent mixing is completed from the measurement input and output station 18 to the rotation
  • the optical signal in the reactor 20 is measured by the measuring device 230; sixth, the waste liquid in the reaction after the measurement is completed is sucked by the waste liquid absorption component 240; seventh, the transfer component 220
  • the reactor 20 is moved from the measurement access station 18 to the reactor 20 out of the rotating disk 210 and discarded to the discard station.
  • the transfer component 220 can move the incubated or washed reactor 20 into the mixing component 120 of the mixing device 100 again, add the second reagent and mix, and the mixing is completed After that, the transfer module 220 moves the reactor 20 after the mixing treatment to the reaction device 200 for incubation, cleaning, separation and measurement.

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Abstract

一种反应装置，包括：旋转盘(210)，所述旋转盘(210)用于对所述反应器(20)中的反应物进行孵育、清洗和测量；清洗组件(250)，位于所述旋转盘(210)上方并能够向反应器(20)中注入清洗液和抽取未结合成分，所述清洗组件(250)包括用于向清洗分离后的反应器(20)内注入信号试剂的注信号试剂部；信号试剂混匀单元(430)，用于对加入信号试剂后的反应器(20)进行信号试剂混匀；测量器(230)，与所述旋转盘(210)连接，对加入信号试剂后的反应器(20)中的反应物进行光信号的测量；及转移组件(220)，能够将反应器(20)在所述旋转盘(210)和信号试剂混匀单元(430)之间转移。

Description

反应装置和免疫分析仪 技术领域
本发明涉及体外诊断技术领域，特别是涉及一种反应装置和免疫分析仪。
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加入待测样本和试剂(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，本文有时简称清洗)等步骤后，再在反应器中加入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的测量分析。
对于传统的免疫分析仪，由于反应装置的体积较大，导致整个免疫分析仪存在结构不够紧凑的缺陷。
发明内容
根据本申请的各种实施例，提供一种能提高结构紧凑性的反应装置。
一种反应装置，包括：
旋转盘，所述旋转盘用于对所述反应器中的反应物进行孵育、清洗和测量；
清洗组件，位于所述旋转盘上方并能够向反应器中注入清洗液和抽取废液，所述清洗组件包括用于向清洗分离后的反应器内注入信号试剂的注信号试剂部；
信号试剂混匀单元，用于对加入信号试剂后的反应器进行信号试剂混匀；
测量器，与所述旋转盘连接，对加入信号试剂后的反应器中的反应物进行光信号的测量；及
转移组件，能够将反应器在所述旋转盘和信号试剂混匀单元之间转移。
一种免疫分析仪，包括上述任一的反应装置。
本发明的一个或多个实施例的细节在下面的附图和描述中提出。本发明的其它特征、目的和优点将从说明书、附图以及权利要求书变得明显。
附图说明
为了更好地描述和说明这里公开的那些发明的实施例和/或示例，可以参考一幅或多幅附图。用于描述附图的附加细节或示例不应当被认为是对所公开的发明、目前描述的实施例和/或示例以及目前理解的这些发明的最佳模式中的任何一者的范围的限制。
图1为第一实施例提供的免疫分析仪的平面结构示意图；
图2为图1中混匀装置的立体结构示意图；
图3为第二实施例提供的免疫分析仪的平面结构示意图；
图4为图3中混匀装置的立体结构示意图；
图5为一实施例提供的串联式混匀方法的流程框图；
图6为一实施例提供的并联式混匀方法的流程框图；
图7为一实施例提供的试剂吸取方法的流程框图；
图8为一实施例提供的稀释方法的流程框图；
图9为一实施例提供的免疫分析方法的流程框图。
具体实施方式
为了便于理解本发明，下面将参照相关附图对本发明进行更全面的描述。附图中给出了本发明的较佳实施方式。但是，本发明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发明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。
样本试剂(或称反应物)孵育特指反应器开始清洗(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、酶标、稀释液、解离剂等试剂组分，例如T4试剂(thyroxine，甲状腺素)包含磁粒、酶标、解离剂三个组分。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、抗原和标记抗体的复合物，同时去除含游离(Free,游离)的标记抗体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在加入信号试剂后，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，即在一个单个周期中，不同的过程操作分别专用于不同的试验。因此，测试通常在多个周期内完成，其中，用于进行测试的不同过程操作发生在不同的周期。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，比如试剂移液单元数量为N个(N≧2,为自然数)时，每个试剂移液单元工作在第一周期，第一周期长度为第二周期的N倍，且N个试剂单元的动作序列连续“错开并行”第二周期。本发明可以实现高通量的免疫测试，典型的第二周期长度为4-15秒，对应的测试通量为每小时900-240个测试，即每小时可以连续报告900-240个结果。
同时参阅图1至图4，本发明一实施例提供的免疫分析仪10包括混匀装置100、反应装置200、试剂供给装置300、样本供给装置410和反应器供给装置420。反应器供给装置420用于提供洁净且空置的反应器20，样本供给装置410用于为空置的反应器20中加入样本，试剂供给装置300用于为盛放有样本的反应器20中再加入试剂，混匀装置100用于对盛放有样本和试剂的反应器20进行混匀处理，反应装置200用于对反应器20中混匀处理后的样本和试剂进行孵育、清洗和测量。
在一些实施例中，反应器供给装置420包括供给料仓、排序机构、供给滑道和供给盘。供给料仓用于存放洁净且空置的反应器20，供给料仓可以位于试剂供给装置300的后方，这样可以充分利用整机空间，使免疫分析仪10的结构变得更为紧凑，排序机构用于将散乱放置的反应器20进行整理以按一定秩序排列，供给滑道将排序后的反应器20逐个导入至供给盘，供给盘用于缓存供给滑道输送过来的反应器20，反应器20可以沿供给盘的周向间隔排列，供给盘可以绕自身的中心轴线转动，从而带动反应器20到指定位置，该指定位置可以定义为反应器供给工位，供给盘上的反应器20将于反应器供给工位转移至混匀装置100。
在一些实施例中，样本供给装置410包括样本架、样本管、输送轨道和样本移液单元411等。样本架可以与输送轨道配合，样本管放置在样本架上，样本管用于盛放样本，例如，每个样本架上可以放置五个至十个左右的样本管。当样本架带动样本管沿输送轨道运动至指定位置时，样本移液单元411吸取样本管的样本，并将样本加入至空置的反应器20中。样本移液单元411可以采用钢针或一次性吸嘴，为了实现对样本的顺利吸取，样本移液单元411可以进行竖直上下运动、水平直线运动或水平转动等运动形式。
同时参阅图1和图2，在一些实施例中，混匀装置100为串联式，该串联式混匀装置101包括运输组件110和混匀组件120，运输组件110上至少设置两个混匀组件120，运输组件110能够带动所有混匀组件120朝同一方向同步运动，简而言之，所有混匀组件120串联在一个运输组件110上。
运输组件110包括机架111和设置于所述机架111上的传送器。传送器用于带动所有混匀组件120朝同一方向同步运动，可以由同步带、丝杠传动、齿轮齿条等传动形式或机构的一种或几种组成。
在一些实施例中，传送器包括电机113、主动轮114和从动轮115以及同步带112，电机113用于驱动主动轮114转动，同步带112缠绕在主动轮114和从动轮115上，当电机113转动时，主动轮114和从动轮115带动同步带112移动。
每个混匀组件120包括支座121、驱动器123和承载台122，支座121滑动设置在机架111上并与运输组件110的传送器连接。具体地，机架111上可以设置滑轨，支座121与滑轨配合，同步带112带动支架沿滑轨延伸的方向滑动，驱动器123安装在支座121上并与承载台122连接，承载台122用于放置反应器20，同步带112可以驱动每个混匀组件120上的支座121均朝同一方向运动，驱动器123能够带动承载台122产生偏心震荡，从而使反应器20中的反应物因产生非接触式偏心震荡而实现混匀。
承载台122上可以设置至少两个容置孔122a，反应器20插置在该容置孔122a中，从而实现承载台122对反应器20的承载作用。当然，容置孔122a还可以采用托架等实体结构进行替换，只要能将反应器20放置在承载台122上即可。
当混匀组件120的数量为两个时，其中一个混匀组件120包括第一支座1211和第一承载台1221，另外一个混匀组件120包括第二支座1212和第二承载台1222，第一支座1211具有第一安装端1211a，第二支座1212具有第二安装端1212a，第二安装端1212a靠近第一安装端1211a设置。第一承载台1221位于第一安装端1211a，第二承载台1222位于第二安装端1212a，简而言之，第一承载台1221和第二承载台1222相对设置，这样便于样本和试剂能够在指定位置加入至不同承载台122上的反应器20中。
参阅图5，当采用上述串联式混匀装置101对样本和试剂进行混匀时，可以形成串联式混匀方法，该串联式混匀方法主要包括如下步骤：
S510，提供用于承载反应器20的至少两个混匀组件120，采用同一运输组件110同步驱动混匀组件120在第一工位11和第二工位12之间循环往复运动；即同步带112驱动所有承载台122在第一工位11和第二工位12之间运动。
S520，向处于第一工位11处的反应器20中加入样本，向处于第二工位12处的反应器20中加入试剂，将反应器20中的样本和试剂进行混匀处理。当同步带112驱动承载台122运动到第一工位11时，同步带112停止运动，由于样本移液单元411设置在第一工位11附近，样本移液单元411将吸取样本并加入至其中一个反应器20中；样本加入完毕后，同步带112驱动承载台122运动到第二工位12时，同步带112停止运动，可以通过试剂供给装置300中的试剂移液单元310将试剂加入至盛放有样本的反应器20中。当反应器20中加入有样本和试剂后，可以使驱动器123带动承载台122产生偏心震荡，以将反应器20中的样本和试剂通过非接触偏心震荡的方式进行混匀处理。
S530，将混匀组件120执行的动作序列或任务，包括移入反应器20、接受样本移液单元411加入样本、接受试剂移液单元310加入试剂、偏心震荡、移出已混匀完成的反应器20等动作，可循环重现的最短时间窗口记为第一周期，即混匀组件120连续两次执行同一动作的最小时间间隔为第一周期。用第一周期除以混匀组件120数量所得的值记为第二周期。从向其中一个混匀组件120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每个混匀组件120中移入反应器20。可以理解，为了实现上述步骤，运输组件110的工作周期为第二周期，混匀组件120的工作周期为第一周期。运输组件110在每个第二周期内可同步驱动混匀组件120在第一工位11和第二工位12之间循 环往复运动。
S540，将已混匀完成的反应器20依次错开一个第二周期所间隔的时间移出混匀组件120，在移出反应器20的混匀组件120上移入新的反应器20。
本发明可以实现高通量的免疫测试，第二周期的长度可以为4-15秒内任何合适的值，比如4秒、5秒、6秒、9秒等,对应的测试通量为每小时900-240个测试，即每小时可以连续报告900-240个结果。
以下为了叙述方便以10秒为例进行说明。
下面以运输组件110驱动两个混匀组件120同步运动为例进行说明，假如免疫分析仪10必须每隔10秒完成对一个反应器20的测量，即每隔10秒报告一个测试结果，此时，第二周期的时间为10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，故混匀装置100上同样必须每隔10秒输出一个已混匀处理完毕的反应器20。假如在只有一个混匀组件120的情况下，由于混匀组件120在一个周期内执行的移入反应器20、接受样本移液单元411加入样本、接受试剂移液单元310加入试剂、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10秒，混匀装置100将无法每隔10秒输出一个已混匀处理完毕的反应器20，混匀装置100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20秒，同时使得混匀组件120的数量为两个，使两个混匀组件120执行的动作序列相对错开第二周期的时间(即10秒)执行，即两个混匀组件120相隔一个第二周期而“错开并行”，在每个混匀组件120每隔20秒输出一个已混匀处理完毕的反应器20的基础上，整个混匀装置100将每隔10秒输出一个已混匀处理完毕的反应器20，最终达到“数量换时间”的目的。
当然，还可以设置初始工位13，使运输组件110带动混匀组件120在初始工位13、第一工位11和第二工位12之间循环往复运动；在初始工位13时，反应器20被移入或移出混匀组件120。初始工位13、第一工位11和第二工位12可以设置在同一直线上，并使初始工位13处于第一工位11和第二工位12之间，使得混匀组件120在初始工位13、第一工位11和第二工位12之间的运动轨迹为直线。初始工位13、第一工位11和第二工位12可以也可以设置在同一圆周上，使得混匀组件120在初始工位13、第一工位11和第二工位12之间做圆周运动。与传统的混匀组件120在单个工位固定不动相比，运输组件110带动混匀组件120在多个工位之间循环往复运动，使混匀组件120在不同工位有条不紊地完成不同的动作序列，减少了样本移液单元411、试剂移液单元310等单元的运动行程，可以实现对反应器20更加灵活高效的任务操作，如接收反应器20、接收样本、试剂和混匀等任务，从而提高整机的测试通量。
具体而言，该串联式混匀装置101开始工作时，在初始工位13处向第一承载台1221上第一次加入一个反应器20，此时，第二承载台1222上并未加入反应器20；传送器驱动第一承载台1221和第二承载台1222从初始工位13运动至第一工位11，向第一承载台1221上的反应器20中加入样本；传送器驱动第一承载台1221和第二承载台1222从第一工位11运动至第二工位12，向第一承载台1221上盛放有样本的反应器20中加入试剂；第一承载台1221产生偏心震荡，使其反应器20中的样本和试剂开始混匀；传送器驱动第一承载台1221和第二承载台1222从第二工位12返回至初始工位13，此时，第一承载台1221和第二承载台1222于第10秒抵达初始工位13，向第二承载台1221上第一次加入反 应器20；传送器驱动第一承载台1221和第二承载台1222从初始工位13运动再次至第一工位11，向第二承载台1222上的反应器20中加入样本；传送器驱动第一承载台1221和第二承载台1222从第一工位11运动再次至第二工位12，向第二承载台1222上盛放有样本的反应器20中加入试剂；第二承载台1222产生偏心震荡，使其反应器20中的样本和试剂开始混匀；传送器驱动第一承载台1221和第二承载台1222从第二工位12返回至初始工位13，此时，第一承载台1221和第二承载台1222于第20秒抵达初始工位13，在第一承载台1221上第二次加入反应器20，并向第一工位11运动。根据此混匀规律，当第一承载台1221和第二承载台1222于第20秒抵达初始工位13时，在第二承载台1222上第二次加入反应器20。依次类推，第一承载台1221和第二承载台1222于第20秒、第30秒、第10N秒(N≧2)抵达初始工位13时，均会有反应器20移入到混匀装置100。同样地，由于每个混匀组件120工作周期为第一周期(20秒)且混匀组件120之间的动作序列并行错开第二周期(10秒)，每个混匀组件120每隔20秒完成一个混匀处理的反应器20并从混匀装置100移出至反应装置200中，但整个混匀装置100每隔10秒会输出一个混匀处理完成的反应器20，使得混匀装置100的流量等于流水线的出口流量。事实上，当其中一个混匀组件120上的反应器20在混匀的同时，充分利用该混匀时间，在另一个混匀组件120上的反应器20加入样本或试剂，从而使整个混匀装置100的流量满足测试通量的要求。
当然，当第二周期仍然为10秒时，第一周期的时间还可以更长，此时使混匀组件120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30秒或40秒等。这样在保证测试通量的基础上，可以减少运输组件110的运动速度，延长样本和试剂的混匀时间，有效解决运输组件110的运动速度瓶颈和样本、试剂的混匀时间瓶颈。在运输组件110的运动速度和样本、试剂的混匀时间一定的情况下，每个混匀组件120仍然每隔20秒输出一个混匀处理完成的反应器20，即第一周期仍然为20秒，如需提高免疫分析仪10的测试通量，例如要求每5秒的时间(第二周期)输出一个已测量完毕的反应器20，可以将运输组件110上的混匀组件120增加至四个；又如要求每4秒的时间(第二周期)输出一个已测量完毕的反应器20，可以将运输组件110上的混匀组件120增加至五个。
可以在每个混匀组件120设置至少两个混匀位，混匀位即为承载台122上的容置孔122a，当其中一个混匀位(容置孔122a)被正在混匀或完成混匀的反应器20占用时，将反应器20移入该混匀组件120上的其它空闲混匀位(容置孔122a)。这样可以解决反应器20在同一承载台122上移入和移出过程中的混匀位占用问题，提高测试效率和测试通量。
对反应器20中的样本和试剂进行的混匀处理，可以在运输组件110驱动混匀组件120运动停止后进行，也可在运动过程中进行，例如，当混匀组件120从第二工位12返回至初始工位13的过程中，驱动器123使承载台122产生偏心震荡以混匀样本和试剂。在运动过程中进行混匀处理可以充分利用混匀组件120运动过程中的时间对样本和试剂进行混匀，确保混匀装置100满足测试通量要求。
加载有样本和试剂的反应器20从开始混匀到混匀完成所需的时间通常为2-10秒，运输组件110工作周期为第一周期，两个混匀组件120为第二周期，使得样本和试剂存在足够的时间进行混匀，确保样本和试剂能够产生充分反应，提高后续测量结果的精确性。
同时参阅图3和图4，在一些实施例中，混匀装置100为并联式，该并联式混匀装置102包括至少两个混匀机构103，每个混匀机构103包括运输组件110和混匀组件120，混匀组件120设置在运输组件110上，运输组件110驱动混匀组件120运动。例如每个混匀机构103包括一个运输组件110和一个混匀组件120时，各个混匀组件120之间行程相互并联关系。运输组件110和混匀组件120的结构与上述串联式混匀装置100中的对应结构相同，即每个运输组件110包括机架111和设置于机架111上的传送器，每个混匀组件120包括支座121、驱动器123和承载台122，在此不再赘述。其与串联式混匀装置100的主要不同点在于：混匀组件120分别设置在不同的运输组件110上，不同运输组件110上的混匀组件120的运动不同步。
在一些实施例中，至少一个混匀机构103包括一个运输组件110和至少两个混匀组件120，该运输组件110驱动上述至少两个混匀组件120同步运动，此时，该混匀机构103上的至少两个混匀组件120相互串联，该混匀机构103上的混匀组件120与其它混匀机构103上的混匀组件120相互并联，即整个混匀装置100中的混匀组件120同时存在并联和串联(即混联)关系。
参阅图6，当采用上述并联式混匀装置102对样本和试剂进行混匀时，可以形成并联式混匀方法，该并联式混匀方法主要包括如下步骤：
S610，提供至少两个运输组件110，使每个运输组件110上设置有用于承载反应器20的混匀组件120，各运输组件110驱动混匀组件120在第一工位11和第二工位12之间循环往复运动。
S620，向处于第一工位11处的反应器20中加入样本，向处于第二工位12处的反应器20中加入试剂，将反应器20中的样本和试剂进行混匀处理。
S630，将混匀组件120执行的动作序列或任务，包括移入反应器20、接受样本移液单元411加入样本、接受试剂移液单元310加入试剂、偏心震荡、移出已混匀完成的反应器20等动作，可循环重现的最短时间窗口记为第一周期，即混匀组件120连续两次执行同一动作的最小时间间隔为第一周期。用第一周期除以混匀组件120数量所得的值记为第二周期。从向其中一个运输组件110上的混匀组件120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运输组件110上的混匀组件120上移入反应器20。可以理解，为了实现上述步骤，每个运输组件110和混匀组件120的工作周期都为第二周期。
S640，将已混匀完成的反应器20依次错开一个第二周期所间隔的时间移出混匀组件120，在移出反应器20的混匀组件120上放入新的反应器20。
下面以运输组件110的数量为两个，其每个运输组件110上设置一个混匀组件120为例进行说明，与串联式混匀方法的相同之处请参照上面的描述。假定第二周期为10秒，而每个混匀机构103每隔20秒输出一个已混匀完毕的反应器20，即第一周期为20秒，由于依次错开一个第二周期所间隔的时间(10秒)先后向其它运输组件110上的混匀组件120上移入反应器20，最终使得整个混匀装置100将每隔10秒输出一个已混匀处理完毕的反应器20，同样能够起到“数量换时间”的作用。
参照上述对于串联式混匀方法的描述，在并联式混匀方法中，同样可以设置初始工位13，使运输组件110带动混匀组件120在初始工位13、第一工位11和第二工位12之间循环往复运动；在初始工位13时，反应器20被移入或移出混匀组件120。初始工位13、第一工位11和第二工位12可以设置 在同一直线上，并使初始工位13处于第一工位11和第二工位12之间，使得混匀组件120在初始工位13、第一工位11和第二工位12之间的运动轨迹为直线。
与传统的混匀组件120在单个工位固定不动相比，运输组件110带动混匀组件120在多个工位之间循环往复运动，提高了整机的测试通量。
每个混匀组件120设置至少两个混匀位，混匀位即为承载台122上的容置孔122a，两个混匀位同时使用或交替使用，可以提高混匀组件120对反应器20的处理效率。当其中一个混匀位(容置孔122a)被占用时，可将反应器20移入该混匀组件120上的另外一个混匀位(容置孔122a)上。可在运输组件110驱动混匀组件120运动的过程中或运动停止后，对反应器20中的样本和试剂进行混匀处理，即对反应器20中的样本和试剂的混匀不受运输组件110运动状态的限制，这样可以使混匀装置100更灵活高效。
具体而言，该并联式混匀装置100开始工作时，将其中一个运输组件110记为第一运输组件1101，另外一个运输组件110记为第二运输组件1102。在初始工位13处向第一运输组件1101上的承载台122第一次加入一个反应器20，此时第二运输组件1102上的承载台122并未加入反应器20。
对于第一运输组件1101，当其从初始工位13运动到第一工位11时，向第一运输组件1101的承载台122上的反应器20加入样本；第一运输组件1101从第一工位11运动至第二工位12，向第一运输组件1101的承载台122上盛放样本的反应器20中加入试剂；第一运输组件1101的承载台122产生偏心震荡，使其反应器20中的样本和试剂开始混匀。
对于第二运输组件1102，在第一次向第一运输组件1101上的承载台122加入反应器20后的第10秒，向第二运输组件1102上的承载台122第一次加入反应器20，并使第二运输组件1102根据第一运输组件1101的运动规律开始运动。依次类推，第一运输组件1102上的承载台122和第二运输组件1102上的承载台122于第20秒、第30秒、第10n秒抵达初始工位13时，均会有反应器20移入到混匀装置100。同样地，由于每个混匀组件120工作周期为第一周期(20秒)且混匀组件120之间的动作序列并行错开第二周期(10秒)，每个混匀组件120每隔20秒完成一个混匀处理的反应器20并从混匀装置100移出至反应装置200中，但整个混匀装置100每隔10秒会输出一个混匀处理完成的反应器20。
对于并联式混匀方法，将运输组件110带动混匀组件120相隔一个第二周期(10秒)而“错开并行”，尽管每个混匀机构103相隔20秒(第一周期)输出一个已混匀完毕的反应器20，但是两个混匀机构103错开10秒从初始工位13开始运行，从而使得整个混匀装置100每隔10秒(第二周期)输出一个已混匀处理完毕的反应器20。通过增加混匀机构103的数量，在使整个混匀装置100的流量满足测试通量要求的基础上，运输组件110能够以较慢的速度运动，解决了运输组件110的运动速度瓶颈和样本、试剂之间的混匀时间瓶颈。其它相似之处请参照上述串联式混匀方法的相关描述。
当至少一个运输组件110上设置的混匀组件120的数量不少于两个时，使得该运输组件110驱动设置在其上的所有混匀组件120同步运动，即至少一个混匀机构103包括至少两个混匀组件120，该混匀机构103上的混匀组件120为串联关系，因此，整个混匀装置100上的混匀组件120同时存在并联与串联关系，同样地，使得每个混匀组件120相隔一个第二周期的时间第一次加入反应器20，最终使整个混匀装置100相隔一个第二周期的时间输出一个已混匀处理完毕的反应器20。通过将部分混匀组 件120串联设置，可以使得整个混匀装置100的结构更为紧凑。
同时参阅图1和图3，在一些实施例中，试剂供给装置300靠近第二工位12设置，试剂供给装置300包括试剂移液单元310和存储单元320，存储单元320的数量至少为两个，存储单元320上设置多个存储部321，存储部321用于放置和存储试剂容器，试剂则盛放在试剂容器中，试剂移液单元310用于吸取存储部321上的试剂容器内的试剂组分，并将试剂组分加入至处于第二工位12处的反应器20中。存储部321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320上的存储部321的数量最好为15-50个，比如每个存储单元320上的存储部321的数量都为25个，这样两个存储单元320一共可以同时在线存储50个试剂容器。每个存储单元320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中加入磁粒、酶标和解离剂共三个试剂组分，则将磁粒、酶标和解离剂三个组分盛放在同一个存储单元320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。比如存储单元数量为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，也可以1个TSH试剂容器装载在其中一个存储单元、另外2个装载在另一个存储单元。
对于传统的试剂供给装置300，为增加分析项目的存储量，必须增加存储部321的数量，从而导致整个存储单元320的尺寸增大，存储单元320占用面积较大，不利于存储单元320的布局和生产制造，另一方面，对于体积和重量较大的存储单元320，也增加了对其运动控制的难度，导致存储部321无法在很短的时间内抵达指定位置以供试剂移液单元310吸取试剂，成为实现高测试通量的一个瓶颈。此外，传统的试剂供给装置300将用于同一分析项目的多个试剂组分盛放在不同的存储单元320上，不仅使得试剂移液单元310在多个不同的存储单元320上吸取同一分析项目的试剂，导致试剂移液单元310行程较大和运动逻辑复杂，无法实现高测试通量，还要求试剂组分盛放在多个试剂容器中，导致生产制造成本高、用户操作不便等问题，此外，由于同一分析项目的多个试剂组分盛放在不同的存储单元320上，当某个存储单元故障不工作时，还会直接导致仪器无法继续测试。
上述实施例的试剂供给装置300通过设置至少两个存储单元320，每个存储单元320体积较小，有利于整机布局和运动控制，也能确保整个试剂供给装置300有较大的试剂存储量。同时，每个存储单元320存放相应分析项目所需的全部试剂组分，可以提高试剂供给装置300的可靠性和对故障的容忍度，当其中一个存储单元320出现故障而无法工作时，其它剩余存储单元320可以继续工作，确保试剂供给装置300仍能有效工作。当然，可以在其它存储单元320工作的同时，对出现故障的存储单元320进行整修。
存储单元320可以为转动盘，转动盘进行周期性间歇转动，从而带动存储部321到指定位置(即吸液工位14)，以便试剂移液单元310在吸液工位14吸取存储部321上的试剂。试剂移液单元310可以与转动盘的数量相等，每个转动盘分别对应一个试剂移液单元310，每个试剂移液单元310从与其对应的转动盘中吸取试剂。与样本移液单元411相类似，试剂移液单元310可以采用钢针或一次性吸嘴，为了实现对试剂的顺利吸取，试剂移液单元310可以进行竖直上下运动、水平直线运动或水平转动等运动形式。当然，试剂移液单元310的数量也可以为一个，该一个试剂移液单元310在多个转动盘中 吸取试剂。
试剂供给装置300还包括扫描器，扫描器设置在存储单元320上，扫描器可以识别存储部321上试剂容器的条码信息，从而用以区分不同的试剂。为使整个试剂供给装置300结构紧凑，扫描器采用固定式设置。存储单元320上还可以设置制冷器，制冷器可以对存储部321中的试剂进行冷藏处理，从而实现在线长期保存试剂。
参阅图7，为了实现高通量的免疫测试，当采用上述试剂供给装置300对试剂进行吸取时，可以形成对试剂的吸取方法，该吸取方法主要包括如下步骤：
S710，提供试剂移液单元310和至少两个用于存储试剂的存储单元320，将试剂容器存放在存储单元320的多个存储部321上，使每个存储单元320存放相应分析项目所需的全部试剂组分。
S720，将存储部321跟随存储单元320运动，使试剂移液单元310从抵达至吸液工位14的存储部321中吸取试剂。存储单元320的运动可以为转动，例如存储单元320做周期性间歇转动，从而使吸液工位14处每隔设定时间均有存储部321抵达，以便试剂移液单元310吸取试剂。
S730，将每个存储单元320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，即存储单元320连续两次执行同一动作的最小时间间隔为第一周期。用第一周期除以存储单元320的数量所得的值记为第二周期。从其中一个存储单元320第一次带动存储部321朝吸液工位14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320带动存储部321朝相应的吸液工位14运动。
以两个存储单元320为例进行说明，根据流量处处相等的原理，该第二周期的值与上述混匀方法中所提到的第二周期的值是相等的，同样以10秒为例进行说明，即每个10秒有一个存储部321抵达吸液工位14以供试剂移液单元310吸取试剂。当然，该第一周期的值与上述混匀方法中所提到的第一周期的值同样是相等的，即第一周期的值为20秒。参照上述混匀方法的基本原理，将两个存储单元320相隔一个第二周期而“错开并行”，尽管每个存储单元320每相隔20秒将有一个存储部321抵达相应的吸液工位14，但是两个存储单元320的动作序列先后错开10秒开始执行，从而使得整个试剂供给装置300每个10秒将有一个存储部321抵达吸液工位14供试剂移液单元310吸取试剂，通过增加存储单元320的数量以换取时间，在使整个试剂供给装置300的流量满足测试通量要求的基础上，可以使存储单元320以较慢的速度转动，继而解决了存储单元的运动速度瓶颈。当然，当存储单元320的数量越多时，在存储单元320转动速度不变的情况下，可以增大整个试剂供给装置300的流量，进而提高免疫分析仪10的测试通量。
在一些实施例中，如果适当降低免疫分析仪测试通量或者采用其它高成本设计提高存储单元的运动速度，存储单元320的运动速度不成为免疫分析仪测试通量的瓶颈时，多个存储单元320的动作序列可以“同步串行”，即多个存储单元320在工作周期内的动作序列同步，在工作周期间串行，在每个工作周期内每个存储单元320都可将目标存储部321定位至吸液工位14以供试剂移液单元310吸取试剂，但每个工作周期只需一个存储单元320将目标存储部321定位至吸液工位14以供试剂移液单元310吸取试剂。以两个存储单元320(分别记为第一存储单元、第二存储单元)、工作周期10秒为例进行说明。在第1个10秒,第一存储单元的一个存储部321抵达吸液工位14以供试剂移液单元310吸取试剂；第2个10秒,第二存储单元的一个存储部321抵达吸液工位14以供试剂移液单元310吸取试剂；第3 个10秒,第一存储单元的一个存储部321抵达吸液工位14以供试剂移液单元310吸取试剂；按此规律，每个10秒两个存储单元320在周期间交替串行,将一个存储部321抵达吸液工位14以供试剂移液单元310吸取试剂。当然，也可以在第1、第2、…第N个10秒(N≧1),第一存储单元将存储部321定位至吸液工位14以供试剂移液单元310吸取试剂；第N、(N+1)、…第(N+M)个10秒(M≧1),第二存储单元将存储部321定位至吸液工位14以供试剂移液单元310吸取试剂。总之，任一个工作周期，都可由其中的一个存储单元将存储部321定位至吸液工位14以供试剂移液单元310吸取试剂。
对于同一存储单元320，存放一个测试对应分析项目所需的全部试剂组分，便于试剂移液单元310快速吸取试剂，提高试剂供给装置300供给试剂的流量。另一方面，当该存储单元320出现故障时，仪器可以利用其它存储单元320继续测试，不影响仪器测试的正常进行，提高了对故障的容忍度。此外，一个测试对应分析项目所需的全部试剂组分放在同一个存储单元320，可以用一个含有多个试剂腔的试剂容器盛放，不仅节约了生产制造成本，还方便用户装卸等操作。
在存储部321跟随存储单元320转动(公转)的过程中，使存储部321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。
多个存储单元320为独立设置，即每个存储单元320可以独立旋转将存储部321上的试剂定位至吸液工位14。需要指出的是，此处的“独立设置”与存储单元320之间的空间布局和物理位置无关，比如多个存储单元320可以分开不重叠的分布在仪器上，也可以其中一个存储单元320嵌套在另一个存储单元320的外围或内侧。当然为了更好的布局和控制，多个存储单元320最好为相同构造且分开布局。多个存储单元320独立设置，可以提高控制的灵活性，进一步提高试剂供给的效率，从而提高仪器的处理通量。
可以使试剂移液单元310与存储单元320的数量相等，且每个存储单元320分别对应一个试剂移液单元310，即每个存储单元320均由与其对应的试剂移液单元310吸取试剂。显然，试剂移液单元310的数量增多时，在满足测试通量的基础上，可以减低每个试剂移液单元310的运行速度，解决试剂移液单元310的运动速度瓶颈。
同时参阅图1和图3，在一些实施例中，反应装置200包括旋转盘210、转移组件220、测量器230、清洗组件250。旋转盘210上设置有孵育圈203、清洗圈202和测量圈201，孵育圈203、清洗圈202和测量圈201均环绕旋转盘210的旋转中心设置，孵育圈203上设置有孵育位213，孵育位213沿孵育圈203的周向间隔设置；清洗圈202上设置有清洗位212，清洗位212沿清洗圈202的周向间隔设置；测量圈201上设置有测量位211，测量位211沿测量圈201的周向间隔设置。孵育位213、清洗位212和测量位211均用于放置反应器20，三者可以为槽孔或托架等合适承载反应器20的结构。测量器230与旋转盘210连接，测量器230能够对加入信号试剂后的反应器20进行光信号的测量，以实现对反应物的进一步分析。清洗组件250位于清洗圈202的上方，包括注液部和吸液部，注液部对清洗位212上的反应器20进行注清洗缓冲液、吸液部可以下降和上升进出清洗位212上的反应器20内抽取移除反应器20内的未结合成分。进一步地，为了精简结构，清洗组件250还包括注信号试剂部，用于向清洗位212上的清洗分离后的反应器20内注入信号试剂。在一些实施例中，反应装置200还包括吸废液 组件240和信号试剂混匀单元430。吸废液组件240位于测量圈201的上方，反应器20测量完毕后，吸废液组件240可以下降和上升进出测量位211上的反应器20中，将反应器20内的废液(主要为信号试剂)吸除，最后将吸除废液后的反应器20移送至丢弃站，以实现固体垃圾和液体垃圾的分置处理，减少生物危害风险。进一步地，吸废液组件240可以连接在清洗组件250的吸液部上，与清洗组件250的吸液部一起可以下降到反应器内底部吸取液体，吸完后再抬离反应器。这样可以充分利用清洗组件250的功能，缩减了机构体积和节省了成本，避免了独立设置吸废液组件而导致的结构复杂、成本高等问题。信号试剂混匀单元430独立于旋转盘210设置，包括与前述混匀组件120类似或相同的混匀组件，对含有信号试剂的反应器20进行偏心震荡混匀。
转移组件220将已混匀处理完毕的反应器20从混匀装置100上移出并移入至孵育位213，反应器20在跟随旋转盘210转动的过程中，孵育位213对反应器20中经混匀处理后的样本和试剂孵育设定时间。反应器20孵育完毕后，转移组件220将反应器20从孵育位213转移至清洗位212，反应器20在跟随旋转盘210转动的过程中，清洗组件250的注液部可以向处于清洗位212中的反应器20中先注入清洗液，然后通过磁场将磁粒复合物吸附在反应器20内侧壁上，清洗组件250的吸液部再从反应器20中抽取未结合成分，经过多轮“注入清洗液—吸附—抽取未结合成分”后，反应器20的反应物完成清洗分离。反应器20的反应物清洗分离完成后，注信号试剂部可以向反应器20中加入信号试剂，转移组件220将加入信号试剂的反应器20从清洗位212转移至信号试剂混匀单元430，通过信号试剂混匀单元430对其进行混匀。为了使信号试剂充分混匀又不影响仪器的测试通量，信号试剂混匀时长为2-6秒。含有信号试剂的反应器20混匀完成后，转移组件220将反应器20从信号试剂混匀单元430转移至测量位211，若需要对盛有信号试剂的反应器20继续进行信号孵育，可以在反应器20跟随旋转盘210转动的过程中，测量位211对反应器20进行孵育设定时间，当反应器20跟随旋转盘210前进到测量器230所在位置时，测量器230对反应器20中的反应物信号测量以便对反应物进行分析。
孵育圈203、清洗圈202和测量圈201三者同心设置，即三者均以旋转盘210的旋转中心为圆心。孵育圈203、清洗圈202和测量圈201环绕旋转中心由内向外依次间隔设置，即测量圈201靠近旋转盘210的边缘，孵育圈203靠近旋转盘210的中心，清洗圈202设置在孵育圈203和测量圈201之间。为了满足分析项目孵育时间的要求，在保证孵育位213的数量的同时又不导致反应装置200的旋转盘210的尺寸过大，孵育圈203的数量至少为两个，例如可以为2-10个，其中最靠近旋转中心的孵育圈203记为内孵育圈，最远离旋转中心的孵育圈203记为外孵育圈。根据清洗效率的需要，清洗圈202的数量设置为1-2个。测量圈201的数量为1个，可以满足测量的需要。
反应装置200设置有孵育进出工位15、清洗移入工位16、清洗移出工位17和测量进出工位18。为了反应器可以进出反应装置200的各个孵育圈203、清洗圈202和测量圈201，孵育进出工位15的数量不少于孵育圈203的数量，清洗移入工位16和清洗移出工位17的数量分别与清洗圈202的数量相等，测量进出工位18的数量不少于测量圈201的数量，即至少为一个。进一步地，为了整机布局的紧凑，同时减少转移组件220的运动行程和提高其可靠性，并进一步提升工作效率，清洗移入工位16和清洗移出工位17分别设置在旋转盘210的旋转中心的两侧，即位于清洗圈202直径的两端，孵育进出工位15与清洗移入工位16同侧，测量进出工位18与清洗移出工位17同侧。这样从孵育进出工位 15移出的反应器可以就近从清洗移入工位16移入到清洗圈202，从清洗移出工位17移出的反应器可以就近从测量进出工位18移入测量圈201。
具体地，以一步法反应模式的测试为例，转移组件220将混匀装置100上的反应器20从孵育进出工位15移入至孵育位213，当反应器20跟随旋转盘210运动至孵育进出工位15时，转移组件220将反应器20从孵育进出工位15移出孵育位213、并从清洗移入工位16移入至清洗位212；当反应器20跟随旋转盘210运动到清洗移出工位17时，转移组件220将反应器20从清洗移出工位17移出清洗位212并移入信号试剂混匀单元430进行信号试剂混匀，混匀完成后再从测量进出工位18移入测量位211；反应器20跟随旋转盘210运动至测量器230所在位置时，测量器230对反应信号测量完毕后，反应器20继续跟随旋转盘210运动至吸废液组件240所在位置，吸废液组件240将反应器20中的废液全部吸除，吸除废液后的反应器20继续跟随旋转盘210运动至测量进出工位18，此时，转移组件220在测量进出工位18将测量完成并吸废液后的反应器20移出测量位211、并将其移入丢弃站。当进行其他反应模式的测试时，比如延时一步法或两步法测试，转移组件220可将从孵育进出工位15移出孵育位213的反应器20、将从清洗移出工位17移出清洗位212的反应器20移入到混匀装置100中。
转移组件220在初始工位13、孵育进出工位15、清洗移入工位16、清洗移出工位17和测量进出工位18之间的运动轨迹为直线，该直线在旋转盘210的正投影通过旋转盘210的旋转中心。这样可以使转移组件220的运动简单化，提高转移组件220的工作效率，以满足测试通量的要求。转移组件220的运动轨迹所在的直线还经过信号试剂混匀单元430，转移组件220可将反应器20在信号试剂混匀单元430和测量圈201、清洗圈202之间转移。
为减少单个转移组件220的运动行程，进一步提高工作效率和控制精度，转移组件220的数量可以设置为两个，并在旋转盘210的内孵育圈内(最靠近旋转中心)设置中继站214，中继站214用于暂时承载反应器20。其中一个转移组件220的运动轨迹在旋转盘210形成第一投影，另外一个转移组件220的运动轨迹在旋转盘210形成第二投影，第一投影和第二投影在中继站214处连接成同一直线，记为轨迹直线；以通过中继站214并垂直于该轨迹直线的直线做为参考直线。其中一个转移组件220负责反应器20位于参考直线右侧部分的转移，另外一个转移组件220负责反应器20位于参考直线左侧部分的转移。比如，两步法反应模式测试时，转移组件220将反应器20从清洗移出工位17移出清洗位212、并移入到混匀组件120加注第二试剂时，需要将反应器20从参考直线的左侧部分转移至右侧部分，可以通过一个转移组件220将反应器20从参考直线的左侧部分的清洗位212先转移至中继站，然后通过另外一个转移组件220将该反应器20从中继站再转移至参考直线的右侧部分的混匀组件120中。
在一些实施例中，为了布局紧凑和进一步提高转移组件220之间的协调配合效率，从而提高仪器通量，中继站214设置于旋转盘210的旋转中心。
同时参阅图1和图3，在该免疫分析仪10中，可以将其中的运输组件110、混匀组件120、样本移液单元411和试剂移液单元310四者组合形成一个稀释装置，即该稀释装置包括运输组件110、混匀组件120和移液组件，该移液组件包括样本移液单元411和试剂移液单元310，当然，运输组件110、混匀组件120、样本移液单元411和试剂移液单元310的结构和位置均可以保持不变。和上述混匀装置 100类似，稀释装置同样可以设置初始工位13、第一工位11和第二工位12，当然，初始工位13也可以省略。
混匀组件120设置在运输组件110上，混匀组件120能够同时承载至少两个反应器20，以同时承载两个反应器20为例，其中一个反应器20记为第一反应器，另外一个反应器20记为第二反应器。混匀组件120上设置至少两个容置孔122a，第一反应器和第二反应器能够分别放置在不同的容置孔122a中。运输组件110驱动混匀组件120在初始工位13、第一工位11和第二工位12之间运动。
在稀释装置的工作过程中，当混匀组件120在初始工位13时，通过转移组件220从供给盘上将第一反应器转移至混匀组件120中；当混匀组件120运动到第一工位11时，通过样本移液单元411吸取样本加入至第一反应器中；当混匀组件120运动到第二工位12时，通过试剂移液单元310吸取稀释液加入至第一反应器中，并对样本和稀释液混匀以形成稀释样本；当混匀组件120再次返回初始工位13时，通过转移组件220向混匀组件120上移入第二反应器；当混匀组件120再次运动到第一工位11时，通过样本移液单元411将稀释样本的一部分从第一反应器中转移至第二反应器，当混匀组件120再次运动到第二工位12时，通过试剂移液单元310吸取试剂组分加入至盛放有稀释样本的第二反应器中，并将稀释样本和试剂组分混匀处理；当混匀组件120最后运动到初始工位13时，通过转移组件220将第二反应器移入反应装置200的孵育位213中。当然，可以将第一反应器移动至丢弃站丢掉。根据上述操作规律，可以通过稀释装置持续不断输出稀释样本和试剂组分已混匀处理的反应器20，实现样本的自动稀释。
进一步地，为了更大提高样本自动稀释的效率，混匀组件120的数量至少为两个，每个混匀组件120都可实现样本的自动稀释，混匀组件120之间可并行或串行实现样本的自动稀释。与前述的串联式混匀装置类似，同一运输组件110同步驱动混匀组件120在第一工位11和第二工位12之间循环往复运动；与前述的并联式混匀装置类似，设置至少两个运输组件110，每个运输组件110上设置有用于承载反应器20的混匀组件120，各运输组件110驱动混匀组件120在第一工位11和第二工位12之间循环往复运动。
参阅图8，当采用上述稀释装置实现样本自动稀释、并对稀释样本和试剂组分进行混匀时，可以形成稀释方法，该稀释方法主要包括如下步骤：
S810，将混匀组件120承载第一反应器运动到第一工位11，向第一反应器20中加入样本；
S820，将盛放有样本的第一反应器运动到第二工位12，向第一反应器中加入稀释液；
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，向混匀组件120上再移入一个第二反应器并再次运动到第一工位11，将第一反应器20中的稀释样本的一部分加入第二反应器中；
S850，将混匀组件120运动到第二工位12，向第二反应器中加入试剂组分；及
S860，将第二反应器中的稀释样本和试剂组分混匀，稀释样本和试剂组分混匀完成后，将第二反应器转移至反应装置200的孵育位213中。
当混匀组件120的数量至少为两个时，每个混匀组件120可在上述稀释步骤中轮流使用。以两个混匀组件120为例，第一样本自动稀释时使用第一混匀组件，第二样本稀释时使用第二混匀组件，第 三样本自动稀释时使用第一混匀组件…
为提高工作效率，将稀释液和试剂组分两者均放置在同一存储单元320上。当稀释样本的一部分加入至第二反应器后，将第一反应器移出混匀组件120并丢弃至丢弃站中，当然，为实现固液分离，可以先将第一反应器中剩余的稀释样本吸取，再将稀释样本全部吸取完成后所形成的第一反应器丢弃。
为便于反应器20移入或移除混匀组件120，将混匀组件120在初始工位13、第一工位11和第二工位12之间循环往复运动，在初始工位13时，第一、第二反应器20被移入或移出混匀组件120。类似地，将初始工位13、第一工位11和第二工位12设置在同一直线上，使初始工位13处于第一工位11和第二工位12之间。对于第一反应器20中的样本和稀释液、以及第二反应器20中的稀释样本和试剂，混匀组件120通过非接触偏心震荡的方式对其混匀。
可以看出，本发明的稀释装置集成了混匀组件120，可在不同工位之间运动，完成样本的自动稀释和混匀，避免了移液单元在一个固定工位稀释，再将反应器转移到另一个工位混匀，提高了稀释混匀的效率和效果，解决了样本自动稀释限制免疫测试的高通量瓶颈问题。
参阅图9，采用上述免疫分析仪10，可以形成一种免疫分析方法，以免疫分析的一步法反应模式为例，该免疫分析方法主要包括如下步骤：
S910，提供用于承载反应器20的至少两个混匀组件120，使混匀组件120带动反应器20在第一工位11和第二工位12之间往复运动。
S920，将混匀组件120执行的动作序列或任务可循环重现的最短时间窗口记为第一周期，即混匀组件120连续两次执行同一动作的最小时间间隔为第一周期，用第一周期除以混匀组件120数量所得的值记为第二周期。从向其中一个混匀组件120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每个混匀组件120中移入反应器20。
S930，将已混匀完成的反应器20依次错开一个第二周期所间隔的时间移出混匀组件120，在移出反应器20的混匀组件120上移入新的反应器20。
S940，将移出混匀组件120并盛放有反应物的反应器20依次进行孵育、清洗分离和测量。反应器20的孵育时间在5-60分钟。
可以理解，该第二周期等于从反应装置200上连续输出相邻两个已测量完毕的反应器20所间隔的时间，即免疫分析仪10连续报告两个相邻测试结果所间隔的时间。
当进行其他方法的反应模式测试时，比如延时一步法和两步法测试，在上述步骤S940中，可将孵育后或清洗后的反应器20按照S920、S930的步骤再次移入到混匀装置100中加入第二试剂和混匀，混匀完成后再按步骤S940进行孵育、清洗分离和测量。
具体地，步骤S940的孵育还可包括如下第一孵育和第二孵育：
第一孵育，含有样本和第一试剂的反应器20孵育设定时间。
第二孵育，将经过第一孵育后的反应器20中再加入第二试剂后孵育设定时间。
当孵育包括第一孵育和第二孵育时，在清洗步骤之前，将经过第一孵育的反应器20按照S920、S930的步骤再次移入到混匀装置100中加入第二试剂和混匀，混匀完成后再按步骤S940进行第二孵育、清洗分离和测量。
试剂分两次加入反应器20中，每次加入试剂组分后对通过混匀装置100对反应器20进行混匀。在一些实施例中，该免疫分析方法还包括如下步骤：
将经过第一孵育后的反应器20进行第一清洗；
将经过第一清洗处理后的反应器20进行第二孵育；
将经过第二孵育的反应器20进行第二清洗。
具体地，当反应器20经过S910、S920、S930步骤后，首先通过反应装置200将反应器20进行第一孵育，接着将第一孵育后的反应器20通过反应装置200进行第一次清洗，第一次清洗后将反应器20按照S920、S930的步骤再次移入到混匀装置100中加入第二试剂和混匀，混匀完成后再按步骤S940进行孵育、第二次清洗和测量。
在一些实施例中，例如，将同一运输组件110驱动所有混匀组件120同步运动，即采用上述串联式的混匀方法对反应器20中的样本和试剂混匀。又如，使运输组件110的数量为多个，且每个运输组件110至少驱动一个混匀组件120运动，即采用上述并联式的混匀方法对反应器20中的样本和试剂混匀。
参考上述串联式和并联式的混匀方法，可以使运输组件110带动混匀组件120在初始工位13、第一工位11和第二工位12之间循环往复运动；在初始工位13时，将反应器20被移入或移出混匀组件120，向处于第一工位11处的反应器20中加入样本，向处于第二工位12处的反应器20中加入试剂。
参考上述反应装置200的结构和工作原理，可以将反应器20从孵育进出工位15进入旋转盘210上的孵育位213进行孵育，将反应器20从清洗移入工位16进入旋转盘210上的清洗位212进行清洗分离，将反应器20从清洗移出工位17将清洗分离完成后的反应器20移出清洗位212，将反应器20从测量进出工位18移入旋转盘210上的测量位211进行测量；使转移组件220在孵育进出工位15、清洗移入工位16、清洗移出工位17和测量进出工位18之间的运动轨迹处于同一直线上。
在旋转盘210的内孵育圈内(最靠近旋转中心)设置中继站214，特别地，在旋转中心处设置有用于暂时承载反应器20的中继站214，并使转移组件220的数量设置为两个，其中一个转移组件220的运动轨迹在所述旋转盘210形成第一投影，另外一个转移组件220的运动轨迹在所述旋转盘210形成第二投影，使第一投影和第二投影在中继站214处连接成同一直线。将孵育位213、清洗分离和测量位211设置在同一旋转盘210上。
当测量完成后，先将反应器20中的废液吸除，再将吸除废液后的反应器20丢弃。
参考上述试剂吸取方法，当混匀组件120在第二工位12时，通过试剂移液单元310从存储单元320上吸取试剂加入至反应器20中，试剂的吸取包括如下子步骤：
提供试剂移液单元310和至少两个用于存储试剂的存储单元320，将试剂盛放在存储单元320的多个存储部321上的试剂容器内。
将存储部321跟随存储单元320运动，使试剂移液单元310于抵达至吸液工位14的存储部321上的试剂容器中吸取试剂。
使每个存储单元320执行的动作序列或任务可循环重现的最短时间窗口等于第一周期，即存储单元320连续两次执行同一动作的最小时间间隔等于第一周期。从其中一个存储单元320第一次带动试 剂朝吸液工位14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320带动试剂朝相应的吸液工位14运动。
在一些实施例中，存储单元320的运动速度不成为免疫分析仪测试通量的瓶颈时，试剂的吸取包括如下子步骤：
提供试剂移液单元310和至少两个用于存储试剂的存储单元320，将试剂盛放在存储单元320的多个存储部321上的试剂容器内。
将存储部321跟随存储单元320运动，使试剂移液单元310于抵达至吸液工位14的存储部321上的试剂容器中吸取试剂。
使多个存储单元320的动作序列同步串行，即多个存储单元320在工作周期内的动作序列同步，在工作周期间串行，在每个工作周期内每个存储单元320都可将目标存储部321定位至吸液工位14以供试剂移液单元310吸取试剂，但每个工作周期只需一个存储单元320将目标存储部321定位至吸液工位14以供试剂移液单元310吸取试剂。总之，任一个工作周期，使其中的一个存储单元将存储部321定位至吸液工位14以供试剂移液单元310吸取试剂。
对于同一存储单元320，盛放相应分析项目所需的全部试剂组分。使试剂移液单元310与存储单元320的数量相等，且每个存储单元320分别对应一个试剂移液单元310。
参考上述稀释方法，当需要样本稀释时，在第二工位12处向反应器20中加入除稀释液成分的其它试剂组分之前，向反应器20中的样本加入稀释液进行稀释以形成稀释样本。
对于单个反应器20，以一步法测试为例，其在免疫分析仪10上的工作流程如下：第一，通过转移组件220从供给盘将空置且洁净的反应器20放置在处于初始工位13的混匀组件120上；第二，运输组件110带动混匀组件120运动到第一工位11，样本移液单元411向位于第一工位11处的反应器20中加入样本；第三，运输组件110带动混匀组件120运动到第二工位12，试剂移液单元310向位于第二工位12处的反应器20中加入试剂，混匀组件120使反应器20中的样本和试剂混匀；第四，转移组件220将混匀处理完毕的反应器20从混匀组件120经孵育进出工位15移入旋转盘210的孵育位213；第五，孵育完毕后，转移组件220将反应器20在孵育进出工位15将其从孵育位213移出、并从清洗移入工位16转移至旋转盘210的清洗位212上；第六，清洗分离完毕后，向反应器20中加入信号试剂，转移组件220将反应器20在清洗移出工位17将其从清洗位212移出并放入到信号试剂混匀单元430混匀，然后转移组件220将信号试剂混匀完成后的反应器从测量进出工位18转移至旋转盘210的测量位211上，通过测量器230对反应器20中的光信号进行测量；第六，通过吸废液组件240将测量完成后反应中的废液吸除；第七，转移组件220将反应器20从测量进出工位18将反应器20移出旋转盘210、并将其丢弃至丢弃站。
当进行延时一步法和两步法测试，转移组件220可将孵育后或清洗后的反应器20再次移入到混匀装置100的混匀组件120中加入第二试剂和混匀，混匀完成后，转移组件220再将混匀处理完毕的反应器20移入反应装置200上进行孵育、清洗分离和测量。
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发明的几种实施方式，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，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (10)

  1. 一种反应装置，其特征在于，包括：
    旋转盘，所述旋转盘用于对所述反应器中的反应物进行孵育、清洗和测量；
    清洗组件，位于所述旋转盘上方并能够向反应器中注入清洗液和抽取未结合成分，所述清洗组件包括用于向清洗分离后的反应器内注入信号试剂的注信号试剂部；
    信号试剂混匀单元，用于对加入信号试剂后的反应器进行信号试剂混匀；
    测量器，与所述旋转盘连接，对加入信号试剂后的反应器中的反应物进行光信号的测量；及
    转移组件，能够将反应器在所述旋转盘和信号试剂混匀单元之间转移。
  2. 根据权利要求1所述的反应装置，其特征在于，对含有信号试剂的反应器进行偏心震荡混匀。
  3. 根据权利要求1所述的反应装置，其特征在于，信号试剂混匀时长为2-6秒。
  4. 根据权利要求1所述的反应装置，其特征在于，所述旋转盘具有环绕其旋转中心设置的孵育圈、清洗圈和测量圈，所述孵育圈沿其周向间隔设置有用于孵育反应器中反应物的孵育位，所述清洗圈沿其周向间隔设置有用于清洗反应器中反应物的清洗位，所述测量圈沿其周向间隔设置有用于测量反应器中反应物信号的测量位；所述转移组件将反应容器在信号试剂混匀单元、孵育位、清洗位和测量位之间转移，所述转移组件的运动轨迹处于同一直线上。
  5. 根据权利要求4所述的反应装置，其特征在于，设置有孵育进出工位、清洗移入工位、清洗移出工位和测量进出工位；所述孵育进出工位用于供反应器进出所述孵育位，所述清洗移入工位用于供反应器移入所述清洗位，所述清洗移出工位用于供反应器移出所述清洗位，所述测量进出工位用于供反应器进出所述测量位，所述转移组件在所述孵育进出工位、清洗移入工位、清洗移出工位和测量进出工位之间运动。
  6. 根据权利要求5所述的反应装置，其特征在于，所述转移组件将含有信号试剂的反应器从所述孵育进出工位移出清洗位并移入到信号试剂混匀单元。
  7. 根据权利要求5所述的反应装置，其特征在于，所述转移组件将信号试剂混匀完成后的反应器从信号试剂混匀单元移出并从测量进出工位移入到测量位。
  8. 根据权利要求5所述的反应装置，其特征在于，所述孵育圈、清洗圈和测量圈环绕所述旋转中心由内向外依次间隔设置。
  9. 根据权利要求4所述的反应装置，其特征在于，还包括吸废液组件，位于旋转盘的测量圈上方，所述吸废液组件用于将测量完成后的反应器中的信号试剂吸除。
  10. 一种免疫分析仪，其特征在于，包括权利要求1至9中任一项所述的反应装置。
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