WO2014169574A1 - 一种样本试剂分注装置、免疫分析仪及其方法 - Google Patents

一种样本试剂分注装置、免疫分析仪及其方法 Download PDF

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Publication number
WO2014169574A1
WO2014169574A1 PCT/CN2013/083961 CN2013083961W WO2014169574A1 WO 2014169574 A1 WO2014169574 A1 WO 2014169574A1 CN 2013083961 W CN2013083961 W CN 2013083961W WO 2014169574 A1 WO2014169574 A1 WO 2014169574A1
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WIPO (PCT)
Prior art keywords
unit
dispensing
reaction
transport
dispensing station
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Application number
PCT/CN2013/083961
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English (en)
French (fr)
Inventor
张震
周鹏
王俊
解传芬
Original Assignee
深圳迈瑞生物医疗电子股份有限公司
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Publication of WO2014169574A1 publication Critical patent/WO2014169574A1/zh
Priority to US14/885,901 priority Critical patent/US20160033487A1/en

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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
    • G01N33/5302—Apparatus specially adapted for immunological test procedures
    • G01N33/5304—Reaction vessels, e.g. agglutination plates
    • 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
    • G01N35/04—Details of the conveyor system
    • 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
    • G01N33/536—Immunoassay; Biospecific binding assay; Materials therefor with immune complex formed in liquid phase
    • 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
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00722—Communications; Identification
    • G01N35/00871—Communications between instruments or with remote terminals
    • 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
    • G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • G01N35/1002—Reagent dispensers
    • 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
    • G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • G01N35/1065—Multiple transfer devices
    • 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
    • G01N35/04—Details of the conveyor system
    • G01N2035/0439—Rotary sample carriers, i.e. carousels
    • G01N2035/0444—Rotary sample carriers, i.e. carousels for cuvettes or reaction vessels
    • 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
    • G01N35/04—Details of the conveyor system
    • G01N2035/0439—Rotary sample carriers, i.e. carousels
    • G01N2035/0458—Multiple concentric rows of wells

Definitions

  • the present application relates to the field of medical devices, and in particular to a sample reagent dispensing device, an immunoassay analyzer and a method thereof.
  • Immunoassays are often used in clinical laboratories to detect various components of blood, urine or other body fluids.
  • the immunoassay analyzer needs to support immune reaction modes such as competition law, sandwich method, indirect method and capture method.
  • Immunoassay methods mainly include radioimmunoassay, enzyme-linked immunosorbent assay and luminescent immunoassay. Due to its environmental protection, high detection sensitivity and wide detection range, luminescent immunoassay has become the main technical means of clinical immunoassay.
  • Luminescence immunoassay is a novel labeling immunoassay method for detecting trace antigens or antibodies by combining luminescence analysis and immune reaction, which achieves a combination of high sensitivity of chemiluminescence and high specificity of immune response.
  • the main principle is to form a magnetic bead reagent on a magnetic bead by coating the corresponding antibody/antigen, and labeling the specific label on the antibody. Labeling reagents are formed on them (the reagents for measuring an analysis item generally have various components, such as magnetic bead reagents, labeling reagents, etc., and different components of the same item can be dispensed in different reagent containers or in the same reagent container.
  • the sample containing the analyte is mixed with the magnetic bead reagent, the labeling reagent and other reagents to form a sample reagent reaction solution (referred to as a reaction solution), and the reaction is formed under certain conditions to form a reaction complex.
  • a reaction solution a sample reagent reaction solution
  • the unbound label and other reagents and sample components in the reaction system are removed by a Bound-free (B/F) technique; a signal reagent is added thereto, and the label and signal reagent on the reaction complex are added.
  • B/F Bound-free
  • the signal reagent may be one or more, such as a luminescent substrate liquid, a pre-excitation liquid, an excitation liquid, a luminescence enhancement liquid, or the like.
  • a luminescent substrate liquid such as a luminescent substrate liquid, a pre-excitation liquid, an excitation liquid, a luminescence enhancement liquid, or the like.
  • the antibody is coated on the reaction vessel wall or plastic beads.
  • the common immune analyzer needs to support the following different test modes.
  • the one-step method refers to adding only one reagent during the test, which is the simplest test mode.
  • the process comprises the steps of: adding a sample and a reagent to the reaction vessel to form a reaction solution and mixing, and placing the mixed reaction container under a constant temperature condition for a certain period of time, then performing cleaning and separation, and then completing the cleaning and separation reaction container.
  • the signal reagent is added, and the reaction vessel after the signal reagent is added is placed under constant temperature for a certain period of time and then metered.
  • Some tests if no incubation is required after the addition of the signal reagent, can be directly metered, such as a chemiluminescence test based on an electrochemiluminescence or flash system, as shown in FIG.
  • the flow is: adding a sample, a reagent (referred to as a first reagent, possibly a plurality of components) to the reaction vessel to form a reaction solution and mixing, and placing the mixed reaction vessel under constant temperature conditions. Incubate the reaction for a certain period of time, then add the reagent (called the second reagent, possibly multiple components) to the reaction vessel and mix it. Place the mixed reaction vessel under constant temperature for a certain period of time and incubate. After the cleaning separation, the signal reagent is added to the reaction vessel in which the cleaning and separation is completed, and the reaction vessel after the signal reagent is added is placed under constant temperature for a certain period of time and then metered. In the two-step one-time wash separation test mode, some tests can be directly metered without the need for incubation after adding the signal reagent.
  • a reagent referred to as a first reagent, possibly a plurality of components
  • the flow is: adding a sample, a reagent (referred to as a first reagent, possibly a plurality of components) to the reaction vessel to form a reaction solution and mixing, and placing the mixed reaction vessel under constant temperature conditions. After incubation for a certain period of time, wash and separate, then add reagents (called second reagents, possibly multiple components) to the reaction vessel and mix them. Place the mixed reaction vessel under constant temperature to incubate.
  • a reagent referred to as a first reagent, possibly a plurality of components
  • the cleaning and separation are carried out, and then the signal reagent is added to the reaction vessel in which the cleaning and separation is completed, and the reaction vessel after the signal reagent is added is placed under constant temperature for a certain period of time and then metered, as described above, some The test can be directly metered without the need for incubation after the addition of the signal reagent.
  • test throughput refers to the number of test results reported by the immunoassay analyzer per unit time.
  • blood cell analysis generally uses a puncture sample needle to dispense a sample, and the sample is then dispensed into a fixed reagent dispensing station using a fluid system to achieve reagent dispensing.
  • This automated analysis device and method is limited to There are few types of reagents, and the liquid path system is complicated, the instrument cost is high, and the reliability is low.
  • the reaction disk is generally used, and a sample dispensing station, a reagent dispensing station, a stirring mixing station, a cleaning station, and the like are disposed on the reaction disk, and the sample needle and the reagent needle disposed near the reaction disk are respectively in the sample.
  • the injection station and the reagent dispensing station dispense the sample and the reagent into the reaction container on the reaction tray.
  • the dispensing device requires the reaction tray to move according to a specific cycle and regularity, and the reaction is performed when the sample and the reagent are dispensed on the reaction tray.
  • the disc must be in a stopped state, which limits the movement of the reaction disk, which has great limitations on the test process requiring flexible and flexible, and the movement of the sample needle and/or the reagent needle must pass through the reaction disk, which limits
  • the layout of the sample needle and / or reagent needle increases the difficulty of implementation.
  • the immunoassay uses a method of setting up a dispensing station outside the incubation reaction zone, that is, dispensing the sample and reagents at the dispensing station, and then dispensing the sample and reagents.
  • the reaction vessel is transferred to the incubation reaction zone in such a way that the sample needle and the reagent needle must be placed around the dispensing station.
  • the sample and reagents are staggered in the dispensing time, so it is only suitable for low-throughput (low-speed) analyzers.
  • reaction vessel that completes the sample and the first reagent dispensing is transferred to the incubation reaction zone for a period of incubation
  • the reaction vessel needs to be transferred to the dispensing station, and the second reagent is added. Subsequent transfer to the incubation reaction zone increases the complexity of the transfer action and the implementation process.
  • the present application provides a sample reagent dispensing device, an immunoassay analyzer and a method thereof, taking into account the layout and testing efficiency of various parts of the instrument.
  • the present application provides a sample reagent dispensing device comprising:
  • a housing unit for carrying the reaction vessel for carrying the reaction vessel.
  • a first dispensing station the first dispensing station being located at a periphery of the housing unit.
  • a second dispensing station is located on the transport trajectory of the housing unit.
  • a dispensing unit the operation track of the dispensing unit passing through the first dispensing station and the second dispensing station for dispensing a first reaction component into a reaction vessel located in the first dispensing station, and The second reaction component is dispensed into the reaction vessel of the second dispensing station.
  • a transport unit for transporting the reaction vessel for transporting the reaction vessel.
  • control unit coupled to the transport unit, the accommodating unit and the dispensing unit, respectively, for controlling the transport unit to transport the reaction container at least between the first dispensing station and the accommodating unit, controlling the transport of the accommodating unit, and controlling the dispensing unit to be located
  • the first reaction component is dispensed in the reaction vessel of the first dispensing station and the second reaction component is dispensed into the reaction vessel located in the second dispensing station.
  • the present application provides a sample reagent dispensing method, comprising the following steps:
  • the control transport unit transports the reaction vessel to a first dispensing station located outside of the housing unit.
  • the control dispensing unit dispenses the first reaction component to the reaction vessel located at the first dispensing station.
  • the control transport unit transports the reaction vessel between the first dispensing station and the housing unit.
  • the control dispensing unit dispenses the second reaction component to the reaction vessel of the second dispensing station located on the transport path of the receiving unit.
  • the present application provides an immunoanalyzer, including the sample reagent dispensing device described above, further comprising:
  • a cleaning unit is located at a periphery of the housing unit for removing unbound components of the reaction system and adding a signal reagent that can react with the reaction complex in the reaction vessel to emit light.
  • the light detecting unit is located at a periphery of the accommodating unit for detecting an optical signal emitted by the object under test in the reaction container carried on the accommodating unit.
  • an immunoassay method comprising the following steps:
  • the control transport unit transports the reaction vessel to a first dispensing station located at the periphery of the housing unit, and the control dispensing unit dispenses the first reaction component to the reaction vessel located at the first dispensing station.
  • the control transport unit transports the reaction vessel between the first dispensing station and the housing unit, and controls the dispensing unit to dispense the second reaction component to the reaction vessel of the second dispensing station located on the transport path of the receiving unit.
  • the control holding unit transports the reaction container carrying the sample and the reagent.
  • the control storage unit transports the reaction container that reaches the incubation time to the transfer station, and the control transport unit transports the reaction container at the transfer station to the cleaning unit for washing and separating operation, and adds the reaction mixture to the reaction container to react with the reaction complex in the reaction container.
  • Luminous signal reagent transports the reaction container that reaches the incubation time to the transfer station, and the control transport unit transports the reaction container at the transfer station to the cleaning unit for washing and separating operation, and adds the reaction mixture to the reaction container to react with the reaction complex in the reaction container.
  • the control housing unit transports the reaction container to which the signal reagent is added to the detection station on the housing unit, and the reaction container is photodetected by the light detecting unit located at the periphery of the housing unit.
  • the dispensing of the two reaction components of the sample and the reagent are respectively performed at the first dispensing station and the second dispensing station, in the first dispensing.
  • the storage unit is not affected by the first reaction component dispensing, and the reaction container can be transported for other operations, thereby realizing the parallel operation of the first reaction component dispensing and other operations of the housing unit.
  • the test efficiency is improved; when the reaction vessel of the storage unit needs to dispense the second reaction component, the storage unit can directly transport the reaction vessel to the second dispensing station to realize the dispensing of one or more second reaction components.
  • test procedure and process are simplified by eliminating the need to transport the reaction vessel out of the containment unit.
  • the dispensing of the sample and the reagent is completed at the first dispensing station and the second dispensing station, respectively, and one of the two dispensing stations is on the accommodating unit transport trajectory and the other is outside the accommodating unit, the sample is dispensed.
  • the arrangement of the dispensing unit and the dispensing unit of the dispensing reagent is no longer limited to the surrounding of the housing unit, but can be separately arranged around the first dispensing station and the second dispensing station, thereby avoiding space between the dispensing units. Limitation and interference. With the dispensing device and method of the present application, the test throughput can be increased while reducing costs.
  • Figure 1 is a schematic diagram showing the principle of measuring components of an immunoassay analyzer
  • FIG. 2 is a schematic diagram of a test flow of a one-step test mode of an immunoassay analyzer
  • FIG. 3 is a schematic diagram of another test flow of the one-step test mode of the immunoassay analyzer
  • FIG. 4 is a schematic diagram of a test flow of a two-step one-time cleaning separation test mode of an immunoassay analyzer
  • FIG. 5 is a schematic diagram of a test flow of a two-step two-cleaning separation test mode of an immunoassay analyzer
  • FIG. 6 is a schematic diagram of a sample reagent dispensing device according to an embodiment of the present application.
  • FIG. 7 is a schematic view of another sample reagent dispensing device according to an embodiment of the present application.
  • FIG. 8 is a schematic view of another sample reagent dispensing device according to an embodiment of the present application.
  • FIG. 9 is a schematic view of another sample reagent dispensing device according to an embodiment of the present application.
  • FIG. 10 is a flow chart of a sample reagent dispensing method according to an embodiment of the present application.
  • FIG. 11 is a schematic diagram of an immunoanalyzer according to an embodiment of the present application.
  • FIG. 13 is a flow chart of another immunoassay method according to an embodiment of the present application.
  • FIG. 14 is a flow chart of another immunoassay method according to an embodiment of the present application.
  • the dispensing station includes a first dispensing station and a second dispensing station, the first dispensing station is disposed at a periphery of the housing unit, and the second dispensing station is disposed to receive On the transfer trajectory of the unit, the dispensing unit dispenses the first reaction component and the second reaction component at the first dispensing station and the second dispensing station, respectively.
  • the accommodating unit serves as a reaction site as a reaction site for the reaction component, and it should be understood that, in the specific immunoassay process, the first reaction component and the second reaction component may include the following four modes:
  • the first reaction component is a sample
  • the second reaction component is a reagent that needs to be added to the reaction vessel.
  • the first reaction component is a sample and a reagent
  • the second reaction component is a reagent that needs to be added to the reaction vessel.
  • the first reaction component is a reagent and the second reaction component is a sample.
  • the first reaction component is a reagent
  • the second reaction component is a sample and a reagent to be added to the reaction vessel.
  • first reaction component and the second reaction component are samples or reagents can be determined according to a specific immunoassay process, wherein the first reaction component and the second reaction component are "first" and “second" "Used only for the purpose of distinguishing names, without any limitation in meaning, the first reaction component and the second reaction component may be collectively referred to as a reaction component.
  • the present application realizes the parallel operation of the first component dispensing and other operations of the accommodating unit by separately setting the first dispensing station and the second dispensing station; at the same time, the dispensing unit is no longer limited to the surrounding of the accommodating unit. Avoid space constraints and interference.
  • Embodiment 1 is a diagrammatic representation of Embodiment 1:
  • the embodiment provides a sample reagent dispensing device, including a transport unit 10, a housing unit 20, a first dispensing station 30, a second dispensing station 201, a dispensing unit 40, and a control unit (not Marked in the drawing).
  • the transport unit 10 is for transporting the reaction vessel in the sample reagent dispensing device.
  • the accommodating unit 20 is for carrying a reaction container, and the transport trajectory of the transport unit 10 passes through the accommodating unit 20.
  • the first dispensing station 30 is located at the periphery of the housing unit 20 and on the transport path of the transport unit 10.
  • the transport unit 10 can transport the reaction vessel between the housing unit 20 and the first dispensing station 30.
  • the second dispensing station 201 is located on the transport trajectory of the accommodating unit 20, and the transport unit 10 can transport the reaction container between the first dispensing station 30 and the accommodating unit 20.
  • the second dispensing station 201 is located on the transport trajectory of the accommodating unit 20, and when the transport unit 10 transports the reaction container between the first dispensing station 30 and the second dispensing station 201, the second dispensing station 201 is The transport station of the accommodating unit 20, where the transport unit 10 can transport the reaction container to or from the accommodating unit 20, in another embodiment, the transport station of the accommodating unit 20 and the second dispensing station 201 are absent At the same position, at this time, the transport unit 10 transports the reaction container from the first dispensing station 30 to the transport station, and the storage unit 20 transfers the reaction container from the transport station to the second dispensing station 201.
  • the trajectory of the dispensing unit 40 passes through the first dispensing station 30 and the second dispensing station 201 for dispensing the first reaction component into the reaction vessel located in the first dispensing station 30, to the second dispensing station.
  • the second reaction component is dispensed into the reaction vessel of 201.
  • the accommodating unit 20 is of a ring structure, and can be a universal disc or rail type accommodating and transporting mechanism, including at least one turn. When more than one turn, the laps can be driven together to reduce the cost of the mechanism, and can be independently driven in separate circles. If the housing unit 20 has three turns, the outer ring can be driven separately, the middle ring and the inner ring can be driven together, or the outer, middle and inner rings can be driven independently to achieve a more flexible and diverse control mode. Each of the rings of the housing unit 20 is distributed with a number of positions, which may be holes or slots, etc., for carrying the reaction vessel and transporting the reaction vessel to a predetermined transport station for operation by other units of the sample reagent dispensing device .
  • the first dispensing station 30 includes a dispensing position 301 for accommodating the reaction vessel for dispensing the first reaction component and a dilution of the reaction components for accommodating the reaction vessel for the absorption of the reaction vessel in the same dispensing unit.
  • Bit 302 (303). Both the dispensing position 301 and the dilution bit 302 (303) are located on the transport trajectory of the transport unit 10 and the operational trajectory of the dispensing unit 40.
  • the first dispensing station 30 is located at the periphery of the housing unit 20, and the movement of the housing unit 20 is no longer restricted by the first dispensing station 30.
  • the dispensing unit 40 dispenses the reaction container at the first dispensing station 30.
  • the containment unit 20 can still carry out a transfer reaction vessel or other operation, which increases the flexibility of the containment unit 20 to transport the reaction vessel, thereby improving the test efficiency and test throughput of the entire apparatus.
  • the second dispensing station 201 is also located on the trajectory of the dispensing unit 40, and the dispensing unit 40 can dispense the second reaction component to the reaction vessel located at the second dispensing station 201.
  • the second dispensing station 201 is disposed on the transport trajectory of the accommodating unit 20 as a transporting station of the accommodating unit 20, and when the reaction container of the accommodating unit 20 requires a plurality of dispensing reagents, the accommodating unit 20 may The reaction container is directly transferred to the second dispensing station 201 to realize the dispensing of the reagent, and the reaction container is not required to be transported out of the accommodating unit 20, which reduces the additional action of the transport unit 10, simplifies the test steps and the flow, and effectively improves the device. Reliability and longevity.
  • the control unit is coupled to the transport unit 10, the accommodating unit 20, and the dispensing unit 40, respectively, for controlling the transport unit 10 to transport the reaction container at least between the first dispensing station 30 and the accommodating unit 20, controlling the transport of the accommodating unit 20, and
  • the control dispensing unit 40 dispenses the first reaction component into the reaction vessel located in the first dispensing station 30 and dispenses the second reaction component into the reaction vessel located in the second dispensing station 201.
  • the control unit is configured to control the sample reagent dispensing device for sample analysis.
  • the control unit may be an automatic control sample analysis step, or may control the corresponding analysis step after receiving the control command from the operator.
  • the first dispensing station 30 is used for dispensing the sample
  • the second dispensing station 201 is used for dispensing the reagent.
  • the first dispensing station 30 can also be used for dispensing the reagent
  • the second dispensing station 201 It can also be used to dispense samples.
  • the first dispensing station 30 is disposed at the periphery of the accommodating unit 20
  • the second dispensing station 201 is disposed on the transport trajectory of the accommodating unit 20
  • the dispensing unit 40 may not It is confined to the periphery of the accommodating unit 20, and the first dispensing station and the second dispensing station are arranged separately, avoiding space limitations and interference between the dispensing units.
  • the suction and dispensing of the sample and the reagent are all completed by the dispensing unit 40, which can save the production cost of the device. Therefore, the sample reagent dispensing device provided in this embodiment can increase the test throughput while reducing the cost during the testing process.
  • the embodiment further provides another sample reagent dispensing device, which is different from the sample reagent dispensing device described above in that the dispensing unit includes a first dispensing unit 401 and a second dispensing unit 402. .
  • the operation trajectory of the first dispensing unit 401 passes through the first dispensing station 30 for dispensing the first reaction component into the reaction container, and the operation trajectory of the second dispensing unit 402 passes through the second dispensing station 201 for A second reaction component is dispensed into the reaction vessel.
  • the structure of the sample reagent dispensing device can be as shown in FIG.
  • the second dispensing unit 402 dispenses reagents to the reaction vessel located at the first dispensing station 30, after which the reaction vessel is transported by the transport unit 10 to the second dispensing station 201, by the first dispensing unit 401 dispenses the sample to the reaction vessel located at the second dispensing station 201.
  • the dispensing unit and the dispensing station in the sample reagent dispensing device do not necessarily have a one-to-one correspondence, and the corresponding relationship between the dispensing unit and the dispensing station may be set according to specific needs.
  • the operation trajectory of the second dispensing unit 402 also passes through the first dispensing station 30.
  • the second dispensing unit 402 can dispense the first reaction component at the first dispensing station 30, or
  • the second reaction component is dispensed at the two dispensing station 201.
  • the first dispensing unit 401 first dispenses the sample to the reaction container located at the first dispensing station, and then the second dispensing unit 401 dispenses the reagent to the reaction container located at the first dispensing station.
  • the reaction vessel is then transported by the transport unit 10 to the second dispensing station 201. If a reagent needs to be dispensed into the reaction vessel during subsequent testing, the reaction vessel can be transported by the holding unit 20 to the second dispensing station.
  • the station 201, the second dispensing unit 402 dispenses reagents to the reaction vessel located at the second dispensing station 201.
  • the embodiment further provides a sample reagent dispensing method, comprising the following steps:
  • Step S10 The control unit controls the transport unit to transport the reaction container to the first dispensing station located at the periphery of the housing unit.
  • the reaction vessel can also be transported by a dedicated transport mechanism to the first dispensing station, such as a transport rack or transport track.
  • Step S11 The control unit controls the dispensing unit to dispense the first reaction component to the reaction vessel located at the first dispensing station.
  • Step S12 The control unit controls the transport unit to transport the reaction container located at the first dispensing station to the second dispensing station located on the housing unit.
  • the second dispensing station is located on the transport trajectory of the accommodating unit, and the transport unit transports the reaction container located at the first dispensing station to the second dispensing station located on the accommodating unit.
  • the second dispensing station is the transport station of the accommodating unit, and the transport station is a position at which the transport unit can transport the reaction container to or from the accommodating unit.
  • the transport station of the accommodating unit is The second dispensing station is not in the same position. At this time, the transport unit transports the reaction container at the first dispensing station to the transport station, and the storage unit transports the reaction container to the second dispensing station.
  • Step S13 The control unit controls the dispensing unit to dispense the second reaction component to the reaction vessel located at the second dispensing station.
  • the dispensing unit in step S11 and step S13 includes a first dispensing unit and a second dispensing unit, and step S11 is specifically a reaction of the first dispensing unit to the first dispensing station.
  • the container dispenses the first reaction component
  • step S13 is specifically that the second dispensing unit dispenses the second reaction component to the reaction vessel located at the second dispensing station.
  • the reagent dispensing method provided in the embodiment further includes a dilution step, specifically: the first transport unit Transferring the reaction vessel at the first dispensing station to the sample to a second dispensing station located on the receiving unit, the second dispensing unit dispensing the diluent into the reaction vessel at the second dispensing station, A transport unit transports the diluted reaction vessel to a dilution position in the first dispensing station for the first dispensing unit to draw the diluted sample for analysis. At this time, the diluted sample is used as a test sample, and the diluted sample located in the dilution position is sucked by the first dispensing unit to continue the test.
  • a dilution step specifically: the first transport unit Transferring the reaction vessel at the first dispensing station to the sample to a second dispensing station located on the receiving unit, the second dispensing unit dispensing the diluent into the reaction vessel at the second dispensing station, A transport unit transports the diluted reaction vessel to a
  • Embodiment 2 is a diagrammatic representation of Embodiment 1:
  • This embodiment provides an immunoanalyzer comprising the sample reagent dispensing device provided in the first embodiment.
  • the immune analyzer includes a first transport unit 101, a second transport unit 102, a housing unit 20, a first dispensing station 30, a second dispensing station 201, and a first point.
  • the transport trajectory of the first transport unit 101 passes through the reaction vessel supply unit 80, the first dispensing station 30, and the accommodating unit 20 for transporting the reaction vessel between the three.
  • the accommodating unit 20 is for carrying a reaction container
  • the first dispensing station 30 is located at the periphery of the accommodating unit 20
  • the second dispensing station 201 is located at the transport trajectory of the accommodating unit 20.
  • the operation trajectory of the first dispensing unit 401 passes through the first dispensing station 30 for dispensing the first reaction component to the reaction vessel located at the first dispensing station 30.
  • the first reaction component is sample.
  • the operation trajectory of the second dispensing unit 402 passes through the second dispensing station 201 for dispensing the second reaction component to the reaction vessel located at the second dispensing station 201.
  • the second reaction component is Reagents.
  • the mixing unit 50 is located at the periphery of the housing unit 20 for mixing the reaction solution in the reaction vessel. In some embodiments, the mixing unit 50 is not required to perform the mixing operation during the testing of the sample and the reagent.
  • the cleaning unit 60 is located at the periphery of the housing unit 20 for removing unbound components of the reaction system and adding a signal reagent that can react with the reaction complex in the reaction vessel to emit light.
  • the transport path of the second transport unit 102 passes through the housing unit 20, the mixing unit 50, and the washing unit 60 for transporting the reaction container between the three.
  • the light detecting unit 70 is located at the periphery of the housing unit 20 for detecting the analyte in the reaction container on the housing unit 20.
  • the light detecting unit 70 may be a photometer that detects the concentration of the object to be tested by detecting the light intensity.
  • the reaction vessel supply unit 80 is for accommodating the reaction vessel, providing a reaction vessel for the immunoanalyzer, and the first transport unit 101 takes a new reaction vessel from the reaction vessel supply unit 80 and transports it to the first dispensing station 30.
  • the reagent tray 90 is for accommodating a reagent container, such as a reagent bottle, and the second dispensing unit 402 draws the reagent from the reagent tray 90 into the reaction container at the second dispensing station 201.
  • the control unit is coupled to the first transport unit 101, the second transport unit 102, the housing unit 20, the first dispensing unit 401, and the second dispensing unit 402, respectively, for controlling the first transport unit 101 at the reaction vessel supply unit 80,
  • the reaction container is transported between the first dispensing station 30 and the accommodating unit 20, and the second transport unit 102 is controlled to transport the reaction container between the accommodating unit 20, the mixing unit 50 and the washing unit 60, and the transport of the accommodating unit 20 is controlled.
  • the control unit is configured to control the immune analyzer for sample analysis, and the control unit may be an automatic control sample analysis step, or may control the corresponding analysis step after receiving the control command issued by the operator.
  • the embodiment further provides an immunoassay method, including the following steps:
  • Step S100 The control unit controls the transport unit to transport a new reaction container from the reaction container supply unit to the dispensing position of the first dispensing station located at the periphery of the receiving unit, and control the dispensing unit to the dispensing position at the first dispensing station.
  • the reaction vessel dispenses the first reaction component.
  • the first reaction component is a sample.
  • the first reaction component can be a reagent.
  • Step S101 When the accommodating unit transfers a vacancy to the second dispensing station, after the sample dispensing is completed, the control unit controls the transport unit to transport the reaction container dispensed with the sample to the second dispensing station located on the accommodating unit.
  • the control unit controls the dispensing unit to dispense the second reaction component to the reaction vessel located at the second dispensing station.
  • the second reaction component is a reagent.
  • the dispensing unit includes a first dispensing unit for dispensing a sample to a reaction container located at the first dispensing station, and a second dispensing unit for drawing the reagent from the reagent tray The reagent is dispensed into the reaction vessel located at the second dispensing station.
  • Step S102 The control unit controls the accommodating unit to transfer the reaction container for dispensing the reagent to the transport station, and the transport unit transports the reaction container to the mixing unit for mixing, and then transports the mixed reaction container back by the transport unit.
  • the transport station is a transport unit that can transport the reaction vessel to or from the location of the containment unit.
  • the transport unit includes a first transport unit and a second transport unit, and the first transport unit is configured to transport the reaction container between the reaction container supply unit, the first dispensing station, and the transport station of the storage unit, the second transport The unit is used to transport the reaction vessel between the transport station of the containment unit and the mixing unit.
  • step S102 can be omitted in the immunoassay method.
  • Step S103 The control unit controls the accommodating unit to transport the mixed reaction container to the incubation position for incubation.
  • the accommodating unit comprises three outer, middle and inner rings. After the mixing operation is completed, the second transport unit can transport it back to the outer, middle and inner three laps of the accommodating unit according to actual needs. Incubate in one turn.
  • Step S104 After the reaction vessel reaches the incubation time, the control unit controls the storage unit to transport it to the transport station, and controls the second transport unit to transport the reaction container to the washing unit for cleaning, and separates and removes unbound components in the reaction system.
  • Step S105 The cleaning unit adds the signal reagent to the reaction vessel after the cleaning separation, and then the reaction container after the signal reagent is added to the storage unit by the transport unit.
  • the second transport unit is further configured to transport the reaction container between the storage unit and the cleaning unit.
  • Step S106 The control unit controls the accommodating unit to transport the reaction container of the dispensing signal reagent to the detecting station located on the accommodating unit, and the analyte in the reaction container is detected by the light detecting unit located at the periphery of the accommodating unit.
  • the immunoassay method provided in this embodiment further includes the following steps between step S100 and step S101:
  • Step S201 The first transport unit transports the reaction container in which the sample is dispensed at the first dispensing station to the second dispensing station located on the receiving unit, and the second dispensing unit moves to the reaction container located in the second dispensing station. Diluting the diluent, the holding unit transports the reaction container to the transport station located in the accommodating unit, and the second transport unit transports the reaction container located in the transport station to the mixing unit for mixing, and then the second transport unit mixes The uniform reaction vessel is transported back to the transport station, and the storage unit transports the reaction vessel to the second dispensing station, and the first transport unit transports the diluted reaction vessel to the dilution position in the first dispensing station for the first dispensing unit Dilute the diluted sample for analysis.
  • the diluted sample is used as a test sample, and the sample diluted in the dilution position is sucked by the first dispensing unit, and dispensed into a new reaction container located in the first dispensing unit, and then transported by the transport unit. Ship to the second dispensing station and wait for the dispensing unit to dispense the reagents to continue the test.
  • the second dispensing unit in step S201 may dispense with the diluent in the reaction container located in the second dispensing station without mixing, and directly dilute the reaction container by the first transport unit. The dilution bit delivered to the first dispensing station.
  • step S105 the method further includes:
  • Step S202 The accommodating unit transports the reaction container of the dispensing signal reagent to the incubation position for incubation.
  • the accommodating unit re-transports the incubated reaction container to the detection station located in the accommodating unit, and the analyte in the reaction container is detected by the light detecting unit located at the periphery of the accommodating unit.
  • the above immunoassay method belongs to the one-step test mode. Please refer to FIG. 14.
  • This embodiment further provides another immunoassay method, which belongs to the two-step one-time wash separation mode, and steps S103 and S104 in the one-step test flow. The following steps have been added between:
  • Step S203 The storage unit transfers the reaction container reaching the incubation time in step S103 to the second dispensing station, and the third reaction component is dispensed into the reaction container by the dispensing unit, and the third reaction component is the second reaction component. Other reagents that have not been dispensed.
  • Step S204 The accommodating unit transfers the reaction container in which the third reaction component is dispensed to the transport station located in the accommodating unit, and the transport unit transports the reaction container located in the transport station to the mixing unit for mixing, and then the transport unit The mixed reaction vessel is transported back to the holding unit.
  • Step S205 The holding unit transports the mixed reaction container to the incubation position for incubation.
  • a washing separation step is further added between step S103 and step S203 to form a two-step two-cleaning separation mode test flow.
  • the transport unit, the accommodating unit and the dispensing unit may perform various operations under the control of the control unit.
  • the dispensing of the sample reagent is completed at the first dispensing station and the second dispensing station, and the first reaction is dispensed at the first dispensing station.
  • the holding unit is not affected by the dispensing of the first reaction component, and the reaction container can be transported for other operations, thereby realizing the parallel operation of the first component dispensing and other operations of the housing unit, thereby improving the testing efficiency;
  • the accommodating unit can directly transport the reaction vessel to the second dispensing station to realize the dispensing of the reagent, and the reaction vessel is not required to be transported out of the accommodating unit, which simplifies the testing procedure and the flow.
  • the setting of the dispensing unit is no longer limited to the surrounding of the housing unit, and the first dispensing station and the second dispensing station are arranged separately, avoiding spatial constraints and interference between the dispensing units.
  • the test throughput can be improved while reducing the cost, and the immune analyzer is also fully applicable to the one-step test mode, the two-step one-time cleaning separation test mode, and the two-step method two-time cleaning separation. Test mode.
  • sample reagent dispensing device and method provided by the present application can be applied not only to an immunoanalyzer but also to other instruments that require sample reagent dispensing, for example, through some changes to a biochemical analyzer. .

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Abstract

一种样本试剂分注装置，包括运送单元（10）、容纳单元（20）、位于容纳单元（20）外围的第一分注站（30）、位于容纳单元（20）上的第二分注站（201）、分注单元（40）和控制单元。一种免疫分析仪，包括上述样本试剂分注装置和清洗单元、光检测单元。本申请中分别在第一分注站（30）和第二分注站（201）分注第一反应组分和第二反应组分，实现了第一反应组分的分注与容纳单元（20）其它操作的并行运行，提高了测试效率；在分注第二反应组分时，无须将反应容器运送出容纳单元（20），简化了测试步骤和流程；其分注单元（40）的设置不再局限于容纳单元（20）周围，第一分注站（30）和第二分注站（201）可以分开布局，避免了分注单元（40）之间空间上的限制和干涉。

Description

一种样本试剂分注装置、免疫分析仪及其方法 技术领域
本申请涉及医疗器械领域，具体涉及一种样本试剂分注装置、免疫分析仪及其方法。
背景技术
免疫分析仪在临床实验室中常被用于检测血液、尿液或其它体液的各项分析成分。免疫分析仪需支持竞争法、夹心法、间接法和捕获法等免疫反应模式。免疫分析方法主要包括放射免疫法、酶联免疫法以及发光免疫法。由于具有环保、检测灵敏度高、检测范围宽等优势，发光免疫法已经成为临床免疫分析的主要技术手段。发光免疫法是将发光分析和免疫反应相结合而建立起来的一种检测微量抗原或抗体的新型标记免疫分析方法，其实现了将化学发光的高灵敏度和免疫反应的高特异性相结合。以一步夹心法为例，测量样本中的某分析成分，请参考图1，其主要原理为：将相应的抗体/抗原包被在磁珠上形成磁珠试剂，将特定的标记物标记在抗体上形成标记试剂（测量某分析项目的试剂一般有多种组分，比如此处的磁珠试剂、标记试剂等，同一项目的不同组分可分装在不同的试剂容器内或同一试剂容器的不同腔内），测试时将含有待测物的样本先后和磁珠试剂、标记试剂及其他试剂混合在一起形成样本试剂反应液（简称反应液），并在一定条件下孵育反应形成反应复合物；通过清洗分离（Bound-free，一般简称B/F）技术，将反应体系中未结合的标记物及其他试剂、样本成分清除；向其中加入信号试剂，反应复合物上的标记物与信号试剂反应（或催化信号试剂）发光。信号试剂可以为一种或多种，如发光底物液、预激发液、激发液、发光增强液等。具体的包被清洗方式也有多种，除了上述的磁珠清洗方式外，还有将抗体包被在反应容器壁、塑料珠等方式。
针对测试项目的不同特点，常见的免疫分析仪需要支持以下几种不同的测试模式。
（1）一步法测试模式
请参考图2，一步法是指在测试过程中仅加入一次试剂，为最简单的一种测试模式。其流程为：向反应容器中加入样本、试剂形成反应液并混匀，将混匀后的反应容器放置到恒温条件下孵育反应一定时间后，进行清洗分离，再向完成了清洗分离的反应容器中加入信号试剂，将加入信号试剂后的反应容器放置到恒温条件下孵育一定时间后测光。有的测试，在加入信号试剂后不需要孵育，则可以直接测光，例如基于电化学发光或闪光体系的化学发光测试，如图3所示。
（2）两步法一次清洗分离测试模式
请参考图4，其流程为：向反应容器中加入样本、试剂（称为第一试剂，可能为多种组分）形成反应液并混匀，将混匀后的反应容器放置到恒温条件下孵育反应一定时间，然后再次向反应容器中加入试剂（称为第二试剂，可能为多种组分）并混匀，将混匀后的反应容器放置到恒温条件下孵育反应一定时间，孵育完成后进行清洗分离，之后向完成了清洗分离的反应容器中加入信号试剂，将加入信号试剂后的反应容器放置到恒温条件下孵育一定时间后测光。在两步法一次清洗分离测试模式中，同样，有的测试在加入信号试剂后不需要孵育，则可以直接测光。
（3）两步法两次清洗分离测试模式
请参考图5，其流程为：向反应容器中加入样本、试剂（称为第一试剂，可能为多种组分）形成反应液并混匀，将混匀后的反应容器放置到恒温条件下孵育反应一定时间后进行清洗分离，然后再次向反应容器中加入试剂（称为第二试剂，可能为多种组分）并混匀，将混匀后的反应容器放置到恒温条件下孵育反应一定时间，孵育完成后进行清洗分离，之后向完成了清洗分离的反应容器中加入信号试剂，将加入信号试剂后的反应容器放置到恒温条件下孵育一定时间后测光，如前所述，有的测试在加入信号试剂后不需要孵育，则可以直接测光。
在免疫分析测试流程中，实现样本和试剂的自动化精确分注是实现免疫自动分析的前提。随着现在免疫分析测试量的增加，在测试流程中，常常需要快速向应容器中分注样本或/和试剂，因此，这就要求在免疫分析仪内部有限的空间内，各个单元紧密配合，以达到免疫分析仪的最大测试通量，以提高测试效率，该测试通量是指免疫分析仪在单位时间内报告测试结果的数目。
在检验自动化分析技术中，血液细胞分析一般采用穿刺式样本针分注样本，样本再采用流体系统分注到固定的试剂分注站，实现试剂的分注，这种自动化分析装置和方法仅限于试剂种类不多的分析，而且其液路系统复杂，仪器成本高，可靠性低。对于生化分析仪，其一般采用反应盘，在反应盘上布置样本分注站、试剂分注站、搅拌混匀站和清洗站等，布局在反应盘附近的样本针和试剂针分别在样本分注站、试剂分注站向反应盘上的反应容器分注样本和试剂，然而这种分注装置要求反应盘按照特定的周期和规律运动，在反应盘上执行样本和试剂分注时，反应盘必须处于停止状态，从而限制了反应盘的运动，这对要求灵活多变的测试流程具有很大的局限性，另外，样本针和/或试剂针的运动轨迹必须经过反应盘，这就限制了样本针和/或试剂针的布局，增加了实现难度。
免疫分析除了采用和生化分析类似的装置和方法外，还采用在孵育反应区外设置分注站的方法，即在分注站实现样本和试剂的分注，然后将分注完样本和试剂的反应容器转移到孵育反应区，这种方式使得样本针和试剂针必须布局在分注站周围，样本和试剂在分注时间上要错开，所以只适用于低通量（低速）的分析仪，且当完成样本和第一试剂分注的反应容器转移到孵育反应区完成一段时间的孵育后，在分注第二试剂时，还需要将反应容器转移到分注站，在加完第二试剂后再转移到孵育反应区，增加了转移动作和实现流程的复杂性。
 发明内容
本申请提供一种样本试剂分注装置、免疫分析仪及其方法，兼顾仪器各部分的布局和测试效率。
根据本申请的第一方面，本申请提供一种样本试剂分注装置，包括：
容纳单元，用于承载反应容器。
第一分注站，所述第一分注站位于容纳单元的外围。
第二分注站，所述第二分注站位于容纳单元的转运轨迹上。
分注单元，所述分注单元的操作轨迹经过所述第一分注站和第二分注站，用于向位于第一分注站的反应容器中分注第一反应组分，和向第二分注站的反应容器中分注第二反应组分。
运送单元，用于运送反应容器。
控制单元，分别耦合到运送单元、容纳单元和分注单元，用于控制运送单元至少在第一分注站和容纳单元之间运送反应容器，控制容纳单元的转运，并控制分注单元向位于第一分注站的反应容器中分注第一反应组分和向位于第二分注站的反应容器中分注第二反应组分。
根据上述样本试剂分注装置，对应的，本申请提供一种样本试剂分注方法，包括下面步骤：
控制运送单元将反应容器运送到位于容纳单元外围的第一分注站。
控制分注单元向位于第一分注站的反应容器分注第一反应组分。
控制运送单元在第一分注站和容纳单元之间运送反应容器。
控制分注单元向位于容纳单元转运轨迹上的第二分注站的反应容器分注第二反应组分。
根据本申请的第二方面，本申请提供一种免疫分析仪，包括上述样本试剂分注装置，还包括：
清洗单元，所述清洗单元位于容纳单元的外围，用于去除反应体系中未结合的成分，并加入可与反应容器内的反应复合物反应发光的信号试剂。
光检测单元，所述光检测单元位于容纳单元的外围，用于检测容纳单元上承载的反应容器内被测物发出的光信号。
根据上述免疫分析仪，对应的，本申请提供一种免疫分析方法，包括下面步骤：
控制运送单元将反应容器运送到位于容纳单元外围的第一分注站，控制分注单元向位于第一分注站的反应容器分注第一反应组分。
控制运送单元在第一分注站和容纳单元之间转运反应容器，控制分注单元向位于容纳单元转运轨迹上的第二分注站的反应容器分注第二反应组分。
控制容纳单元将承载着分注了样本和试剂的反应容器进行转运。
控制容纳单元将达到孵育时间的反应容器转运到运送站，控制运送单元将位于运送站的反应容器运送到清洗单元进行清洗分离操作，并向反应容器内加入可与反应容器内的反应复合物反应发光的信号试剂。
控制容纳单元将加入信号试剂的反应容器转运到位于容纳单元上的检测站，由位于容纳单元外围的光检测单元对反应容器进行光检测。
本申请提供的样本试剂分注装置、免疫分析仪及其方法中，样本和试剂这两种反应组分的分注分别在第一分注站和第二分注站完成，在第一分注站分注第一反应组分时，容纳单元不受第一反应组分分注的影响，可以转运反应容器进行其它操作，实现了第一反应组分分注与容纳单元其它操作的并行运行，提高了测试效率；当容纳单元的反应容器需要分注第二反应组分时，容纳单元可将反应容器直接转运到第二分注站，实现一种或多种第二反应组分的分注，无须将反应容器运送出容纳单元，简化了测试步骤和流程。另外，由于样本和试剂的分注分别在第一分注站和第二分注站完成，而两个分注站一个在容纳单元转运轨迹上，另一在容纳单元外，因此分注样本的分注单元和分注试剂的分注单元的设置不再局限于容纳单元周围，而是可以分别围绕第一分注站和第二分注站分开布局，从而避免了分注单元之间空间上的限制和干涉。采用本申请的分注装置和方法，可以在降低成本的同时提高测试通量。
附图说明
下面结合附图和具体实施方式作进一步详细的说明。
图1为免疫分析仪测量样本分析成分的原理示意图；
图2为免疫分析仪一步法测试模式的测试流程示意图；
图3为免疫分析仪一步法测试模式的另一种测试流程示意图；
图4为免疫分析仪两步法一次清洗分离测试模式的测试流程示意图；
图5为免疫分析仪两步法两次清洗分离测试模式的测试流程示意图；
图6为本申请一种实施例一种样本试剂分注装置示意图；
图7为本申请一种实施例另一种样本试剂分注装置示意图；
图8为本申请一种实施例另一种样本试剂分注装置示意图；
图9为本申请一种实施例另一种样本试剂分注装置示意图；
图10为本申请一种实施例一种样本试剂分注方法流程图；
图11为本申请一种实施例一种免疫分析仪的示意图；
图12为本申请一种实施例一种免疫分析方法的流程图；
图13为本申请一种实施例另一种免疫分析方法的流程图；
图14为本申请一种实施例另一种免疫分析方法的流程图。
具体实施方式
本申请提供的样本试剂分注装置和免疫分析仪，其分注站包括第一分注站和第二分注站，第一分注站设置在容纳单元外围，第二分注站设置在容纳单元的转运轨迹上，分注单元分别在第一分注站和第二分注站分注第一反应组分和第二反应组分。其中，容纳单元作为反应盘为反应组分提供反应场所，应当理解，在具体的免疫分析过程中，第一反应组分和第二反应组分可包括下面四种方式：
1、第一反应组分为样本，第二反应组分为需要加入反应容器的试剂。
2、第一反应组分为样本和试剂，第二反应组分为需要加入反应容器的试剂。
3、第一反应组分为试剂，第二反应组分为样本。
4、第一反应组分为试剂，第二反应组分为样本和需要加入反应容器的试剂。
应当理解，第一反应组分和第二反应组分是样本还是试剂可以根据具体的免疫分析过程进行确定，其中第一反应组分与第二反应组分中的“第一”与“第二”仅作为区别名称的目的而使用，不具有任何含义上的限制，第一反应组分和第二反应组分可统称为反应组分。本申请通过将第一分注站和第二分注站分开设置，实现了第一组分分注与容纳单元其它操作的并行运行；同时，也使得分注单元不再局限于容纳单元周围，避免了空间上的限制和干涉。
实施例一：
请参考图6，本实施例提供了一种样本试剂分注装置，包括运送单元10、容纳单元20、第一分注站30、第二分注站201、分注单元40和控制单元（未在附图中标注）。
运送单元10用于在样本试剂分注装置中运送反应容器。容纳单元20用于承载反应容器，运送单元10的运送轨迹经过容纳单元20。第一分注站30位于容纳单元20的外围且处于运送单元10的运送轨迹上。运送单元10可以在容纳单元20与第一分注站30之间运送反应容器。第二分注站201位于容纳单元20的转运轨迹上，运送单元10可以在第一分注站30与容纳单元20之间运送反应容器。应当理解，第二分注站201位于容纳单元20的转运轨迹上，运送单元10在第一分注站30与第二分注站201之间运送反应容器时，第二分注站201即为容纳单元20的运送站，运送站为运送单元10可以将反应容器运送到或运出容纳单元20的位置，在另一种实施例中，容纳单元20的运送站与第二分注站201不在同一位置上，此时，运送单元10从第一分注站30运送反应容器到运送站，容纳单元20再将反应容器从运送站转运到第二分注站201。分注单元40的轨迹经过第一分注站30和第二分注站201，用于向位于第一分注站30的反应容器中分注第一反应组分，向位于第二分注站201的反应容器中分注第二反应组分。
容纳单元20为环形结构，可以是通用的盘式或轨道式容纳转运机构，包括至少一圈，当不止一圈时，各圈既可一起驱动，以减少机构降低成本，也可分圈独立驱动，如容纳单元20具有三圈时，可以外圈单独驱动、中圈和内圈一起驱动，或者外、中、内圈分别独立驱动以实现更加灵活多样的控制方式。容纳单元20的每个圈分布有一定数量的位置，这些位置可以是孔或槽等，用于承载反应容器并将反应容器转运到预定的运送站，以便样本试剂分注装置的其它单元进行操作。
第一分注站30包括用于容纳反应容器进行分注第一反应组分的分注位301和位于同一分注单元的运动轨迹的用于容纳反应容器进行吸取稀释后的反应组分的稀释位302（303）。分注位301和稀释位302（303）都位于运送单元10的运送轨迹和分注单元40的操作轨迹上。第一分注站30位于容纳单元20的外围，容纳单元20的运动不再受第一分注站30的限制，在分注单元40对位于第一分注站30的反应容器进行分注第一反应组分时，容纳单元20依然可以进行转运反应容器或其它的操作，这便提高了容纳单元20转运反应容器的灵活性，从而提高了整个仪器的测试效率和测试通量。
第二分注站201同样位于分注单元40的操作轨迹上，分注单元40可以向位于第二分注站201的反应容器分注第二反应组分。本实施例中，第二分注站201设置在容纳单元20的转运轨迹上，作为容纳单元20的一个运送站，当容纳单元20的反应容器需要多次分注试剂时，容纳单元20可将反应容器直接转运到第二分注站201，实现试剂的分注，无须将反应容器运送出容纳单元20，减少了运送单元10额外的动作，简化了测试步骤和流程，也有效提高了装置的可靠性和寿命。
控制单元分别耦合到运送单元10、容纳单元20和分注单元40，用于控制运送单元10至少在第一分注站30和容纳单元20之间运送反应容器，控制容纳单元20的转运，并控制分注单元40向位于第一分注站30的反应容器中分注第一反应组分和向位于第二分注站201的反应容器中分注第二反应组分。控制单元用于控制样本试剂分注装置进行样本分析，该控制单元可以是自动控制样本分析步骤，也可以是在收到操作者发出的控制指令后控制相应的分析步骤。
一般的，第一分注站30用于分注样本，第二分注站201用于分注试剂，特别的，第一分注站30也可以用于分注试剂，第二分注站201也可以用于分注样本。
另外，本实施例提供的样本试剂分注装置中，第一分注站30设置在容纳单元20的外围，第二分注站201设置在容纳单元20的转运轨迹上，分注单元40可以不被局限于容纳单元20周围，第一分注站和第二分注站分开布局，避免了分注单元之间空间上的限制和干涉。并且，样本和试剂的吸取、分注都由分注单元40完成，可以节约装置的生产成本。所以，本实施例提供的样本试剂分注装置在测试过程中，可以在降低成本的同时提高测试通量。
请参考图7，本实施例还提供了另外一种样本试剂分注装置，其与上述样本试剂分注装置的区别在于，其分注单元包括第一分注单元401和第二分注单元402。第一分注单元401的操作轨迹经过第一分注站30，用于向反应容器中分注第一反应组分，第二分注单元402的操作轨迹经过第二分注站201，用于向反应容器中分注第二反应组分。样本试剂分注装置的结构可以如图8所示。在一具体实例中，第二分注单元402向位于第一分注站30的反应容器分注试剂，之后由运送单元10将反应容器运送到第二分注站201，由第一分注单元401向位于第二分注站201的反应容器分注样本。
应当理解，在具体的实施过程中，样本试剂分注装置中的分注单元与分注站并不一定是一一对应的关系，可以根据具体需要设置分注单元与分注站的对应关系。请参考图9，第二分注单元402的操作轨迹还经过第一分注站30，第二分注单元402既可以在第一分注站30处分注第一反应组分，也可以在第二分注站201处分注第二反应组分。在一具体测试过程中，先由第一分注单元401向位于第一分注站的反应容器分注样本，再由第二分注单元401向位于第一分注站的反应容器分注试剂，之后由运送单元10将反应容器运送到第二分注站201，在后续的测试过程中如果还需要向反应容器中分注试剂，则可以由容纳单元20将反应容器转运到第二分注站201，第二分注单元402向位于第二分注站201的反应容器分注试剂。
参考图10，根据上述样本试剂分注装置，对应的，本实施例还提供了一种样本试剂分注方法，包括下面步骤：
步骤S10：控制单元控制运送单元将反应容器运送到位于容纳单元外围的第一分注站。当然，在具体操作过程中，反应容器也可以由专用的运送机构运送到第一分注站中，例如传输架或传输轨道。
步骤S11：控制单元控制分注单元向位于第一分注站的反应容器分注第一反应组分。
步骤S12：控制单元控制运送单元将位于第一分注站的反应容器运送到位于容纳单元上的第二分注站中。应当理解，第二分注站位于容纳单元的转运轨迹上，运送单元将位于第一分注站的反应容器运送到位于容纳单元上的第二分注站中 ，此时，第二分注站即为容纳单元的运送站，运送站为运送单元可以将反应容器运送到或运出容纳单元的位置，在另一种实施例中，容纳单元的运送站与第二分注站不在同一位置上，此时，运送单元将位于第一分注站的反应容器运送到运送站，容纳单元再将反应容器转运到第二分注站。
步骤S13：控制单元控制分注单元向位于第二分注站的反应容器分注第二反应组分。
在另一种实施例中，在步骤S11和步骤S13中的分注单元包括第一分注单元和第二分注单元，步骤S11具体为第一分注单元向位于第一分注站的反应容器分注第一反应组分，步骤S13具体为第二分注单元向位于第二分注站的反应容器分注第二反应组分。
在一具体实例中，当步骤S11中的第一组分为样本，样本中分析物浓度过高需要稀释时，本实施例提供的试剂分注方法还包括稀释步骤，具体为：第一运送单元将位于第一分注站分注有样本的反应容器运送到位于容纳单元上的第二分注站中，第二分注单元向位于第二分注站的反应容器中分注稀释液，第一运送单元将稀释后的反应容器运送到第一分注站内的稀释位以供第一分注单元吸取稀释后的样本进行分析。此时，稀释后的样本作为测试样本，由第一分注单元吸取位于稀释位的稀释后的样本继续进行测试。
实施例二：
本实施例提供了一种免疫分析仪，该免疫分析仪包括实施例一中提供的样本试剂分注装置。
请参考图11，在一具体实施例中，该免疫分析仪包括第一运送单元101、第二运送单元102、容纳单元20、第一分注站30、第二分注站201、第一分注单元401、第二分注单元402、混匀单元50、清洗单元60、光检测单元70、反应容器供给单元80、试剂盘90和控制单元（未在附图中标出）。
第一运送单元101的运送轨迹经过反应容器供给单元80、第一分注站30和容纳单元20，用于在三者之间运送反应容器。容纳单元20用于承载反应容器，第一分注站30位于容纳单元20的外围，第二分注站201位于容纳单元20的转运轨迹上。第一分注单元401的操作轨迹经过第一分注站30，用于向位于第一分注站30的反应容器分注第一反应组分，在一具体实例中，第一反应组分为样本。第二分注单元402的操作轨迹经过第二分注站201，用于向位于第二分注站201的反应容器分注第二反应组分，在一具体实例中，第二反应组分为试剂。
混匀单元50位于容纳单元20的外围，用于将反应容器内的反应溶液进行混匀，在某些实施例当中，样本和试剂在测试过程中不需要进行混匀操作时，混匀单元50为免疫分析仪的可选结构。清洗单元60位于容纳单元20的外围，用于去除反应体系中未结合的成分，并加入可与反应容器内的反应复合物反应发光的信号试剂。第二运送单元102的运送轨迹经过容纳单元20、混匀单元50和清洗单元60，用于在三者之间运送反应容器。光检测单元70位于容纳单元20的外围，用于检测容纳单元20上反应容器内的分析物，光检测单元70可以是光度计，通过探测光强来检测待测物的浓度。反应容器供给单元80用于容纳反应容器，为免疫分析仪提供反应容器，由第一运送单元101从反应容器供给单元80中获取新的反应容器运送到第一分注站30中。试剂盘90用于容纳试剂容器，比如试剂瓶，第二分注单元402从试剂盘90中吸取试剂分注到位于第二分注站201的反应容器中。
控制单元分别耦合到第一运送单元101、第二运送单元102、容纳单元20、第一分注单元401和第二分注单元402，用于控制第一运送单元101在反应容器供给单元80、第一分注站30和容纳单元20之间运送反应容器，控制第二运送单元102在容纳单元20、混匀单元50和清洗单元60之间运送反应容器，控制容纳单元20的转运，还用于控制第一分注单元401向位于第一分注站30的反应容器分注第一反应组分，控制第二分注单元402向位于第二分注站201的反应容器分注第二反应组分。控制单元用于控制免疫分析仪进行样本分析，该控制单元可以是自动控制样本分析步骤，也可以是在收到操作者发出的控制指令后控制相应的分析步骤。
请参考图12，根据上述免疫分析仪，对应的，本实施例还提供了一种免疫分析方法，包括下面步骤：
步骤S100：控制单元控制运送单元从反应容器供给单元中运送一个新的反应容器到位于容纳单元外围的第一分注站的分注位，控制分注单元向位于第一分注站分注位的反应容器分注第一反应组分，本实施例中，第一反应组分为样本，在其它实施例中，第一反应组分可以为试剂。
步骤S101：当容纳单元将一空位转运至第二分注站，样本分注完成后，控制单元控制运送单元将分注有样本的反应容器运送到位于容纳单元上的第二分注站。控制单元控制分注单元向位于第二分注站的反应容器分注第二反应组分，相应的，本实施例中，第二反应组分为试剂。分注单元包括第一分注单元和第二分注单元，第一分注单元用于向位于第一分注站的反应容器分注样本，第二分注单元用于从试剂盘吸取试剂后向位于第二分注站的反应容器分注试剂。
步骤S102：控制单元控制容纳单元将分注完试剂的反应容器转运到运送站，由运送单元将反应容器运送到混匀单元进行混匀，之后再由运送单元将混匀后的反应容器运送回容纳单元中。运送站为运送单元可以将反应容器运送到或运出容纳单元的位置。本实施例中，运送单元包括第一运送单元和第二运送单元，第一运送单元用于在反应容器供给单元、第一分注站和容纳单元的运送站之间运送反应容器，第二运送单元用于在容纳单元的运送站与混匀单元之间运送反应容器。在某些实施例中，样本和试剂在测试过程中不需要进行混匀操作时，免疫分析方法中可以省略步骤S102。
步骤S103：控制单元控制容纳单元将混匀后的反应容器转运到孵育位置进行孵育。本实施例中，容纳单元包括外、中、内三圈，反应容器在完成混匀操作后，根据实际需要，第二运送单元可以将其运送回容纳单元外、中、内三圈中的任一圈进行孵育。
步骤S104：在反应容器达到孵育时间后，控制单元控制容纳单元将其转运到运送站，并控制由第二运送单元将反应容器运送到清洗单元进行清洗，分离除去反应体系中未结合的成分。
步骤S105：清洗单元将完成清洗分离后的反应容器中加入信号试剂，再由运送单元将加入信号试剂后的反应容器运送回容纳单元中。本实施例中，第二运送单元还用于在容纳单元与清洗单元之间运送反应容器。
步骤S106：控制单元控制容纳单元将分注信号试剂的反应容器转运到位于容纳单元上的检测站，由位于容纳单元外围的光检测单元检测反应容器内的分析物。
请参考图13，在另一种实施例中，当样本中分析物浓度过高需要稀释时，本实施例提供的免疫分析方法在步骤S100和步骤S101之间还包括下面步骤：
步骤S201：第一运送单元将位于第一分注站分注有样本的反应容器运送到位于容纳单元上的第二分注站中，第二分注单元向位于第二分注站的反应容器中分注稀释液，容纳单元将反应容器转运到位于容纳单元内的运送站，第二运送单元将位于运送站中的反应容器运送到混匀单元进行混匀，再由第二运送单元将混匀后的反应容器运送回运送站，容纳单元将反应容器转运到第二分注站，第一运送单元将稀释后的反应容器运送到第一分注站内的稀释位以供第一分注单元吸取稀释后的样本进行分析。此时，稀释后的样本作为测试样本，由第一分注单元吸取位于稀释位稀释后的样本，分注到位于第一分注单元分注位新的反应容器中，再由运送单元将其运送到第二分注站，等待分注单元分注试剂继续进行测试。在某些实施例中，步骤S201中第二分注单元向位于第二分注站的反应容器中分注稀释液后可以不需要进行混匀，直接由第一运送单元将稀释后的反应容器运送到第一分注站内的稀释位。
在一具体实例中，在步骤S105和步骤S106之间还包括：
步骤S202：容纳单元将分注信号试剂的反应容器转运到孵育位置进行孵育。相应的，步骤S106中容纳单元将孵育后的反应容器再转运到位于容纳单元内的检测站，由位于容纳单元外围的光检测单元检测反应容器内的分析物。
上述免疫分析方法属于一步法测试模式，请参考图14，本实施例还提供了另一种免疫分析方法，属于两步法一次清洗分离模式，其在一步法测试流程中的步骤S103和步骤S104之间增加了下面步骤：
步骤S203：容纳单元将步骤S103中达到孵育时间的反应容器转运到第二分注站，由分注单元向反应容器中分注第三反应组分，第三反应组分为第二反应组分中还未分注的其它试剂。
步骤S204：容纳单元将分注完第三反应组分的反应容器转运到位于容纳单元内的运送站，运送单元将位于运送站中的反应容器运送到混匀单元进行混匀，再由运送单元将混匀后的反应容器运送回容纳单元中。
步骤S205：容纳单元将混匀后的反应容器转运到孵育位置进行孵育。
在另一种免疫分析方法中，在两步法一次清洗分离模式的测试流程基础上，在步骤S103和步骤S203之间再增加清洗分离步骤，形成两步两次清洗分离模式的测试流程。
应当理解，本实施例提供的免疫分析方法中，运送单元、容纳单元和分注单元可以是在控制单元的控制下完成各个操作的。
本申请实施例提供的样本试剂分注装置、免疫分析仪及其方法中，样本试剂的分注在第一分注站和第二分注站完成，在第一分注站分注第一反应组分时，容纳单元不受第一反应组分分注的影响，可以转运反应容器进行其它操作，实现了第一组分分注与容纳单元其它操作的并行运行，提高了测试效率；当容纳单元的反应容器需要分注试剂时，容纳单元可将反应容器直接转运到第二分注站，实现试剂的分注，无须将反应容器运送出容纳单元，简化了测试步骤和流程。另外，分注单元的设置不再局限于容纳单元周围，第一分注站和第二分注站分开布局，避免了分注单元之间空间上的限制和干涉。采用本申请的分注装置和方法，可以在降低成本的同时提高测试通量，该免疫分析仪也完全适用于一步法测试模式、两步法一次清洗分离测试模式和两步法两次清洗分离测试模式。
应当理解，本申请提供的样本试剂分注装置和方法不仅可以应用到免疫分析仪中，也可以应用到其它需要进行样本试剂分注的仪器中，例如通过一些改变也可以应用到生化分析仪中。
以上内容是结合具体的实施方式对本发明所作的进一步详细说明，不能认定本发明的具体实施只局限于这些说明。对于本发明所属技术领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干简单推演或替换。

Claims (11)

  1. 一种样本试剂分注装置，其特征在于，包括：
    容纳单元，用于承载反应容器；
    第一分注站，所述第一分注站位于容纳单元的外围；
    第二分注站，所述第二分注站位于容纳单元的转运轨迹上；
    分注单元，所述分注单元的操作轨迹经过所述第一分注站和第二分注站，用于向位于第一分注站的反应容器中分注第一反应组分，和向第二分注站的反应容器中分注第二反应组分；
    运送单元，用于运送反应容器；
    控制单元，分别耦合到运送单元、容纳单元和分注单元，用于控制运送单元至少在第一分注站和容纳单元之间运送反应容器，控制容纳单元的转运，并控制分注单元向位于第一分注站的反应容器中分注第一反应组分和向位于第二分注站的反应容器中分注第二反应组分。
  2. 如权利要求1所述的装置，其特征在于，还包括与所述第一分注站位于同一分注单元的运动轨迹的用于容纳反应容器进行吸取稀释后的反应组分的稀释位。
  3. 如权利要求1或2所述的装置，其特征在于，所述分注单元包括第一分注单元和第二分注单元，所述第一分注单元的操作轨迹经过第一分注站，所述第二分注单元的操作轨迹经过第二分注站；所述第一分注单元用于向反应容器中分注第一反应组分，所述第二分注单元用于向反应容器中分注第二反应组分。
  4. 如权利要求3所述的装置，其特征在于，所述第二分注单元的操作轨迹还经过第一分注站。
  5. 如权利要求1-4任一项所述的装置，其特征在于，所述容纳单元包括一圈或两圈以上环形结构的盘式或轨道式容纳转运机构，各圈容纳转运机构可以独立驱动或共同驱动。
  6. 一种样本试剂分注方法，其特征在于，包括：
    控制运送单元将反应容器运送到位于容纳单元外围的第一分注站；
    控制分注单元向位于第一分注站的反应容器分注第一反应组分；
    控制运送单元在第一分注站和容纳单元之间运送反应容器；
    控制分注单元向位于容纳单元转运轨迹上的第二分注站的反应容器分注第二反应组分。
  7. 如权利要求6所述的方法，其特征在于，所述第一反应组分为样本，所述第二反应组分为试剂，在控制运送单元将位于第一分注站的反应容器运送到位于容纳单元上的第二分注站步骤之后，和控制分注单元向位于第二分注站的反应容器分注第二反应组分步骤之前，还包括对样本进行稀释的步骤，具体为：控制分注单元向位于第二分注站的反应容器分注稀释液，控制运送单元将分注稀释液的反应容器运送到第一分注站的稀释位中，以供第一分注单元吸取稀释后的样本进行分析。
  8. 一种免疫分析仪，其特征在于，包括：
    如权利要求1-5任一项所述的样本试剂分注装置；
    清洗单元，所述清洗单元位于容纳单元的外围，用于去除反应体系中未结合的成分，并加入可与反应容器内的反应复合物反应发光的信号试剂；
    光检测单元，所述光检测单元位于容纳单元的外围，用于检测容纳单元上承载的反应容器内被测物发出的光信号。
  9. 如权利要求8所述的免疫分析仪，其特征在于，所述运送单元包括第一运送单元和第二运送单元，所述第一运送单元的运送轨迹经过第一分注站和第二分注站，所述控制单元控制第一运送单元在第一分注站和容纳单元之间运送反应容器；所述第二运送单元的运送轨迹经过容纳单元和清洗单元，所述控制单元控制第二运送单元在容纳单元和清洗单元之间运送反应容器。
  10. 如权利要求9所述的免疫分析仪，其特征在于，还包括：
    反应容器供给单元，所述反应容器供给单元位于第一运送单元的运送轨迹上，用于提供反应容器；
    试剂盘，所述试剂盘位于分注单元的操作轨迹上，用于提供试剂；
    所述控制单元还控制第一运送单元在反应容器供给单元和第一分注站之间运送反应容器。
  11. 一种免疫分析方法，其特征在于，包括：
    控制运送单元将反应容器运送到位于容纳单元外围的第一分注站，控制分注单元向位于第一分注站的反应容器分注第一反应组分；
    控制运送单元在第一分注站和容纳单元之间转运反应容器，控制分注单元向位于容纳单元转运轨迹上的第二分注站的反应容器分注第二反应组分；
    控制容纳单元将承载着分注了样本和试剂的反应容器进行转运；
    控制容纳单元将达到孵育时间的反应容器转运到运送站，控制运送单元将位于运送站的反应容器运送到清洗单元进行清洗分离操作，并向反应容器内加入可与反应容器内的反应复合物反应发光的信号试剂；
    控制容纳单元将加入信号试剂的反应容器转运到位于容纳单元上的检测站，由位于容纳单元外围的光检测单元对反应容器进行光检测。
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