WO2019056235A1 - Appareil d'analyse automatique et son procédé de fonctionnement - Google Patents

Appareil d'analyse automatique et son procédé de fonctionnement Download PDF

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Publication number
WO2019056235A1
WO2019056235A1 PCT/CN2017/102536 CN2017102536W WO2019056235A1 WO 2019056235 A1 WO2019056235 A1 WO 2019056235A1 CN 2017102536 W CN2017102536 W CN 2017102536W WO 2019056235 A1 WO2019056235 A1 WO 2019056235A1
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WO
WIPO (PCT)
Prior art keywords
magnetic separation
separation unit
unit
cuvette
reagent
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PCT/CN2017/102536
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English (en)
Chinese (zh)
Inventor
鞠文涛
翁彦雯
王俊
Original Assignee
深圳迈瑞生物医疗电子股份有限公司
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Application filed by 深圳迈瑞生物医疗电子股份有限公司 filed Critical 深圳迈瑞生物医疗电子股份有限公司
Priority to PCT/CN2017/102536 priority Critical patent/WO2019056235A1/fr
Priority to CN201780094103.0A priority patent/CN111033266B/zh
Publication of WO2019056235A1 publication Critical patent/WO2019056235A1/fr

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/27—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using photo-electric detection ; circuits for computing concentration
    • 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

Definitions

  • the invention relates to an automatic analysis device and a method of its operation.
  • An automatic analyzer for example, an immunoassay analyzer, which is a type of high-sensitivity and high-specificity analytical instrument, is often used in clinical laboratories to detect blood, urine, or other body fluids.
  • Traditional immunoassays have a variety of implementation principles, such as chemiluminescence, electrochemiluminescence, and the like.
  • chemiluminescence chemiluminescence
  • electrochemiluminescence electrochemiluminescence
  • the main working principle is mainly: when it is necessary to measure a certain component in the sample, the corresponding antibody/antigen can be coated on the magnetic beads to form a magnetic bead reagent.
  • the reagent for measuring an analysis item generally has a plurality of components, such as a magnetic bead reagent component, a labeling reagent component, etc., and different components of the same item may be Dispense in different reagent containers or in different chambers of the same reagent container).
  • the test process firstly mixes the sample containing the analyte 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 incubates the reaction under certain conditions to form a reaction complex; Bound-free (B/F) technology is used to remove unbound labels and other reagents and sample components in the reaction system; then, a signal reagent is added thereto, and the label on the reaction complex reacts with the signal reagent. (or catalytic signal reagent) luminescence, wherein the signal reagent may be one or more, such as a luminescent substrate solution, a pre-excitation solution and an excitation solution, and a luminescence enhancement solution.
  • a luminescence enhancement solution There are also a variety of specific coating methods. In addition to the magnetic bead cleaning method described above, there are other methods of coating the antibody on the reaction vessel wall, plastic beads, and the like.
  • the present application provides an automatic analysis device comprising at least two magnetic separation units, each of which operates independently for magnetic separation cleaning of a reaction liquid in a cuvette;
  • the automatic analysis device of the separation unit also provides a working method for optimizing the operation method of the automatic analysis device after the failure of the magnetic separation unit.
  • an embodiment provides an operating method of an automatic analysis device, the automatic analysis device comprising at least two magnetic separation units, each magnetic separation unit operating independently for reacting in a cuvette The liquid is subjected to magnetic separation cleaning; the working method includes:
  • the magnetic separation unit not marked as fault is activated to operate.
  • an embodiment provides an operating method of an automatic analysis device, the automatic analysis device comprising at least two magnetic separation units, each magnetic separation unit operating independently for reaction in a cuvette The liquid is subjected to magnetic separation cleaning, and the working method includes:
  • the magnetic separation unit When a faulty magnetic separation unit is detected, the magnetic separation unit is marked as malfunctioning, and the operation of the magnetic separation unit is stopped, and the magnetic separation unit not marked as defective is maintained in normal operation.
  • an automatic analysis apparatus including:
  • At least two magnetic separation units each of the magnetic separation units working independently for magnetic separation cleaning of the reaction liquid in the reaction cup;
  • a fault detecting unit configured to detect whether each magnetic separation unit has a fault
  • control unit configured to control the fault detecting unit to detect whether each magnetic separation unit has a fault before the start of the test, and mark the faulty magnetic detecting unit that the fault detecting unit detects the fault as a fault; when the control unit receives the start test When the signal is signaled, the magnetic separation unit not marked as fault is activated to operate.
  • an automatic analysis apparatus including:
  • At least two magnetic separation units each of the magnetic separation units working independently for magnetic separation cleaning of the reaction liquid in the reaction cup;
  • a fault detecting unit configured to detect whether each magnetic separation unit has a fault
  • control unit configured to control the fault detecting unit to detect whether each magnetic separation unit has a fault after starting the test, and mark the faulty magnetic detecting unit that the fault detecting unit detects the fault as a fault; the control unit stops being marked as faulty
  • the magnetic separation unit operates and maintains the operation of the magnetic separation unit that is not marked as faulty.
  • the automatic analyzing device according to the above embodiment and the working method thereof, through at least two magnetic points
  • the disc is matched with other unit and mechanism test cycles, thereby improving the test speed and the reliability of the whole machine; the present invention introduces a corresponding fault detection mechanism and a working method for fault detection through the at least two magnetic separation discs,
  • the automatic analysis device can continue to operate when one or more magnetic separation units fail, for example, the magnetic separation unit not marked as fault continues to operate, while other units and mechanisms in the automatic analysis device adjust the duty cycle To match the magnetic separation unit that is not marked as faulty.
  • Figure 1 is a test schematic diagram for immunoassay
  • FIG. 3 is a second flowchart of an automatic analysis working method of an embodiment
  • FIG. 4 is a schematic structural view of an automatic analysis device of an embodiment
  • FIG. 5 is a schematic overall structural view of a magnetic separation unit of an embodiment
  • Figure 6 is an exploded view of a magnetic separation unit of an embodiment
  • Figure 7 is a diagram showing the placement of a fourth-order magnetic separation disk of the magnetic separation unit of Figure 4.
  • the one-step test item in the present invention means that only one step of incubation is required for one test item; accordingly, the multi-step test item means that one test item requires multiple steps of incubation, such as a two-step test item.
  • a multi-step test project requires magnetic separation after the final step of incubation, and then the measurement can be performed. In a multi-step test project, except for the last step, after the other steps are incubated, it is not necessary. Magnetic separation depends on factors such as the type of test item. For example, a two-step test project, if the first step of the test requires magnetic separation after incubation, the two-step test project can be called a two-step two-separation test project, if the first test is The magnetic separation is not required after incubation, and the two-step test project can be referred to as a two-step, one-separation test project.
  • the number of reagents to be added for each step of incubation or each incubation may be one type or multiple types, which is determined according to factors such as the type of test item.
  • the test item can be called multi-component test. project.
  • magnetic separation cleaning is an inevitable process and link in various test projects. Since magnetic separation cleaning requires a long fixed time, magnetic separation cleaning is also a long-term process. Especially for some multi-step test projects that require multiple magnetic separation cleaning. Moreover, since the cycle of other units or components in the device needs to be consistent with the above-mentioned magnetic separation cleaning, the test speed and test throughput of the device are limited.
  • multi-step test items and multi-component test items are the main reasons that affect test throughput when working with immunoassays.
  • a multi-component test project since the time required for each suction and discharge of the reagent needle cannot be infinitely compressed, and based on the characteristics of the immune reaction, the reagent needle of the same cycle needs multiple suction and discharge to complete one test.
  • Component dispensing in order to avoid the introduction of cross-contamination through the outer wall when the reagent is sucked into the components of different reagent chambers, the outer wall of the reagent needle needs to be cleaned between the different components, resulting in a multi-reagent group in one step test.
  • the dispensing is one of the longest time-consuming steps in the analysis device. This affects the test throughput.
  • the immunological analyzer sometimes needs to carry out test procedures such as sample pre-dilution and pre-treatment. These "non-standard" test procedures are also a cause of affecting test throughput.
  • the inventors found that the separation time can be solved from the magnetic separation cleaning, the dispensing time of the multi-component reagents in the multi-component test item, and the multiple magnetic separation process. Simplification, process simplification of the multi-step test project, etc., to solve any of the above problems can achieve the effect of improving test speed and test throughput.
  • the inventors first proposed an automatic analysis device comprising at least two magnetic separation units, each of which operates independently for magnetic separation cleaning of the reaction liquid in the cuvette.
  • the magnetic separation unit comprises a magnetic separation disk disposed in a disk-like configuration, the magnetic separation disk having one or more orbits of independent or simultaneous movement, each track including a plurality of placements for placing the cuvette
  • the magnetic separation disc is rotatable and drives the cuvette rotation in its placement position for scheduling the cuvette to the injecting and aspirating positions in the magnetic separation disc to complete the magnetic separation cleaning.
  • the automatic analysis device proposed by the invention has no fixed working step limitation for each magnetic separation unit, and can be used for magnetic separation cleaning in any one-step test in a one-step test project or a multi-step test project, which greatly improves the whole machine. Test speed and test throughput.
  • the present invention also provides an operation method of the automatic analysis device for causing failure of one or more magnetic separation units.
  • the automatic analyzer can continue to work unless all magnetic separation units have failed.
  • the working method of the automatic analyzing device includes steps S40-S42.
  • Step S40 Before the start of the test, it is detected whether each magnetic separation unit has a fault.
  • the magnetic separation unit includes at least one functional motion function component and a detection module for detecting whether each of the motion function components can normally move, and each of the motion function components is configured to perform at least a required process in the magnetic separation cleaning process.
  • a feature Before detecting the start of the test, detecting whether each magnetic separation unit has a fault, controlling each of the motion function components of each magnetic separation unit to move, when the detection module of any magnetic separation unit detects that the magnetic separation unit has any motion function component When the movement is not normal, the magnetic separation unit has failed.
  • Step S41 Marking the faulty magnetic separation unit as a fault.
  • Step S42 When the signal for starting the test is received, the magnetic that is not marked as fault is activated.
  • the separation unit works.
  • initiating operation of the magnetic separation unit not marked as faulting comprises: controlling each of the magnetic separation units not marked as faulty to receive the cuvette in respective corresponding cycles, wherein the magnetic device included in the automatic analysis device
  • the period of the receiving cuvette corresponding to the i-th magnetic separation unit is kN+i periods, N is an integer greater than or equal to 2, and k is an integer greater than or equal to 0, i
  • the value ranges from 1 to N, and i is an integer.
  • the magnetic separation unit is two; when only one magnetic separation unit is not marked as faulty, after it is activated, the magnetic separation unit is controlled to receive the cuvette during the period of its corresponding receiving cuvette. .
  • the cycle of receiving the cuvette corresponding to the magnetic separation unit cannot have a cuvette for completing the magnetic separation cleaning, because there is no corresponding magnetic separation unit to receive the cuvette. Therefore, when there is a failure of the magnetic separation unit, other mechanisms and units in the automatic analysis device originally cooperate to make the malfunctioning magnetic separation unit receive the completion of the incubation and the magnetic separation in the period of the corresponding receiving cuvette. The action of the cleaning cuvette is also stopped accordingly; in other words, when a magnetic separation unit fails, other mechanisms and units of the automatic analysis device that cooperate with the magnetic separation unit need to stop operating in some cycles. The reaction cup that receives the cuvette corresponding to the magnetic separation unit does not appear to receive the cuvette that is ready for magnetic separation cleaning after completion of the incubation.
  • the working method further includes: when only one magnetic separation unit is not marked as a fault, after the startup is started, the sample dispensing mechanism and the reagent are also controlled.
  • the unit and the reagent dispensing mechanism work in an intermittent operation mode of one cycle and then one cycle, respectively, to cooperate with the magnetic separation unit not marked as a fault, so that the cuvette that has been subjected to the magnetic separation cleaning has been completed in time series In the period of receiving the cuvette corresponding to the magnetic separation unit not marked as fault; wherein the sample dispensing mechanism in the automatic analysis device is used for sucking the sample and discharging to the reaction cup located at the sample loading position
  • the reagent unit is used to carry the reagent; the reagent dispensing mechanism is used to draw the reagent and discharge it to the reagent location.
  • the working method of the automatic analyzing device includes steps S50-S52.
  • Step S50 Start the test.
  • each magnetic separation unit is controlled to receive the cuvette in a corresponding period, wherein when the automatic analysis device includes N magnetic separation units, then the i-th magnetic separation unit corresponds to The period of receiving the cuvette is kN+i cycles, N is an integer greater than or equal to 2, k is an integer greater than or equal to 0, and i ranges from 1 to N, and i is an integer.
  • the two magnetic separation units are two, and the two magnetic separation units are controlled to receive the cuvettes in respective corresponding periods, wherein one of the magnetic separation units corresponds to a period of receiving the cuvettes with an odd period, and The period of the receiving cuvette corresponding to one magnetic separation unit is an even period.
  • Step S51 Monitor whether each magnetic separation unit has a fault.
  • the magnetic separation unit not marked as faulty is maintained in normal operation, including controlling the magnetic separation unit to still receive the cuvette during the period of its corresponding receiving cuvette.
  • the detection module of each magnetic separation unit detects whether the moving functional components of the magnetic separation unit are moving normally in real time, and when the detection module of any magnetic separation unit detects that any of the magnetic separation units has a moving function component, the normal operation is not normal.
  • the magnetic separation unit can be marked as a fault in step S52.
  • Step S52 When the faulty magnetic separation unit is detected, the magnetic separation unit is marked as a fault, and the operation of the magnetic separation unit is stopped, and the magnetic separation unit not marked as fault is maintained in normal operation.
  • the magnetic separation unit not marked as faulty is maintained in normal operation, including controlling the magnetic separation unit to still receive the cuvette during the period of its corresponding receiving cuvette.
  • the magnetic separation unit not marked as fault is maintained in normal operation, and includes: controlling sample points.
  • the injection mechanism, the reagent unit and the reagent dispensing mechanism respectively operate in an intermittent operation mode of one cycle and one cycle, respectively, to cooperate with the magnetic separation unit not marked as a fault, so that the magnetic separation cleaning is about to be completed after the incubation is completed.
  • the cuvette is in time series in the period of receiving the cuvette corresponding to the magnetic separation unit not marked as fault; wherein the sample dispensing mechanism in the automatic analyzing device is used for sucking the sample and discharging to the sampled position In the reaction cup; the reagent unit is used to carry the reagent; the reagent is dispensed
  • the mechanism is used to draw the reagent and discharge it to the reagent location.
  • the working method further comprises: when the faulty magnetic separation unit is detected, marking the corresponding test result of the cuvette located in the faulty magnetic separation unit to distinguish the normal test result.
  • the working method further comprises: when the faulty magnetic separation unit is detected, performing a cupping operation on the cuvette that has started testing and is to be assigned to the faulty magnetic separation unit, and The test results corresponding to the cuvettes of the throwing cup are marked to distinguish normal test results.
  • the working method further includes: when the faulty magnetic separation unit is detected, an alarm is issued to inform the user that the magnetic separation unit is faulty.
  • the present invention also provides an automatic analysis device that, in an embodiment, can operate in accordance with the above described method of operation.
  • the automatic analysis device includes, in addition to the at least two magnetic separation units described above, a fault detection unit and a control unit for detecting whether each magnetic separation unit is faulty.
  • control unit is configured to control the fault detecting unit to detect whether each magnetic separating unit has a fault before the start of the test, and mark the faulty detecting unit to detect that the faulty magnetic separating unit is faulty; when the control unit receives the fault; When the signal to start the test is started, the magnetic separation unit not marked as fault is started to operate.
  • the control unit controls each of the magnetic separation units not marked as faults to receive the cuvettes in respective corresponding periods, wherein when the automatic analysis device includes N magnetic separation units, then the i-th magnetic
  • the period of the receiving cuvette corresponding to the separating unit is kN+i periods, N is an integer greater than or equal to 2, k is an integer greater than or equal to 0, and i ranges from 1 to N, and i is an integer.
  • the magnetic separation unit is two. When only one magnetic separation unit is not marked as faulty, after the operation is started, the control unit controls the magnetic separation unit to receive within the period of its corresponding receiving cuvette. Reaction cup.
  • control unit when only one magnetic separation unit is not marked as faulty, the control unit further controls the sample dispensing mechanism, the reagent unit and the reagent dispensing mechanism to respectively perform the intermittent operation mode of one cycle and one cycle of operation to match the magnetic wave not marked as fault.
  • the separation unit operates such that the cuvette that has completed the incubation of the magnetic separation wash is in time series within the period of the receiving cuvette corresponding to the magnetic separation unit not marked as faulty.
  • control unit is configured to control the fault detecting unit to detect whether each magnetic separating unit has a fault after starting the test, and mark the faulty detecting unit that the faulty magnetic separating unit is faulty; the control unit stops being The operation of the magnetic separation unit marked as faulty and the operation of the magnetic separation unit not marked as faulty.
  • control unit controls each of the magnetic separation units to receive the cuvettes in respective corresponding periods, wherein when the automatic analysis device includes N magnetic separation units, the i-th magnetic separation unit The period of the corresponding receiving cuvette is kN+i cycles, N is an integer greater than or equal to 2, k is an integer greater than or equal to 0, and i ranges from 1 to N, and i is an integer.
  • control unit controls the two magnetic separation units to receive the cuvettes in respective corresponding periods, wherein the period of the receiving cuvette corresponding to one magnetic separation unit is an odd cycle, and The period of the receiving cuvette corresponding to one magnetic separation unit is an even period.
  • control unit maintains operation of the magnetic separation unit not marked as faulty by controlling the magnetic separation unit to still receive the cuvette during the period of its corresponding receiving cuvette.
  • control unit also controls the sample dispensing mechanism, the reagent unit, and the reagent dispensing mechanism to intermittently stop one cycle for one cycle of operation, respectively.
  • the control unit controls the cup that has started the test and is to be assigned to the faulty magnetic separating unit to perform a cupping operation, and The test results corresponding to the cups subjected to the cupping operation are marked to distinguish normal test results.
  • the control unit also marks the corresponding test result of the cuvette located in the faulty magnetic separating unit to distinguish the normal test result.
  • control unit issues an alarm to notify the user that the magnetic separation unit is faulty when a faulty magnetic separation unit is detected.
  • the above is some basic structure and working methods of the automatic analysis device.
  • the following is an example. Explain the automatic analysis.
  • the automatic analysis device includes a cuvette loading mechanism 1, a sample unit 33, a sample dispensing mechanism 3, a reagent unit 5, a reagent dispensing mechanism 6, a reaction tray 4, a mixing mechanism, a measuring unit 10, and a magnetic separation unit. , transfer mechanism and control unit (not shown).
  • the cuvette loading mechanism 1 is used to supply and carry the cuvette to the split cup position.
  • the split cup position is used by the transfer mechanism to dispatch the cuvette to the sample loading position.
  • the cuvette device mechanism includes a silo 101, a picking mechanism 102, a reversing mechanism 103, and a transport mechanism 104.
  • the silo 101 is used to store the cuvette.
  • Pickup mechanism 102 is used to pick up, transport, and unload the cuvette.
  • the reversing mechanism 103 is coupled to the pick-up mechanism 102, and the reversing mechanism 103 has a transfer groove disposed obliquely downward from the side of the pick-up mechanism 102, the transfer groove having a size allowing the lower portion of the cuvette to extend, and the width of the transfer groove It is smaller than the width of the hanging portion on the reaction cup, and the transfer groove has a first groove bottom wall at least at an end close to the pick-up mechanism 102, and the distance from the first groove bottom wall to the upper edge of the transfer groove is smaller than the distance from the bottommost portion of the reaction cup to the hanging portion.
  • the transfer mechanism 104 is coupled to the reaction cup outlet of the transfer tank, and the transfer mechanism 104 has at least one reaction cup for storing the cuvette for placing the cuvette; the rotary mechanism 104 has the above-described split cup position, for example, will rotate One of the reaction cup positions on the mechanism 104 is set to a split cup position.
  • Sample unit 33 is used to carry the sample.
  • the sample unit 33 includes a sample delivery module including a sample delivery module (SDM) module and a front end track (not shown).
  • SDM sample delivery module
  • front end track not shown.
  • the sample dispensing mechanism 3 is used to suck the sample and discharge it into the cuvette located in the sample loading position.
  • the sample dispensing mechanism 3 includes a sample needle and the sample needle is one.
  • the entire flow of the sample dispensing mechanism 3 to complete the loading or dispensing is as follows: moving to the sampling position, and then moving to the corresponding cleaning position to clean the outer wall, and then moving to the loading position will absorb The sample is discharged to the reaction cup located at the sample loading position, and finally moved to the corresponding cleaning position for cleaning the inner and outer walls.
  • the cleaning of the sample dispensing mechanism 3 can be performed at the sample needle cleaning unit 32.
  • Reagent unit 5 is used to carry reagents.
  • the reagent unit 5 is disposed in a disc-like structure, and the reagent unit 5 has a plurality of positions for carrying the reagent container, and the reagent unit is rotatable and drives the reagent container carried by the reagent container to rotate, for rotating the reagent container to The reagent is taken up for the reagent dispensing mechanism 6 to take up the reagent.
  • the reagent unit 5 is one, which can be separately disposed outside the reaction disk 4.
  • the reagent dispensing mechanism 6 is for aspirating the reagent and discharging it into a cuvette located at the reagent addition position.
  • the reagent dispensing mechanism 6 includes a reagent needle and the reagent needle is one.
  • the reagent dispensing mechanism 6 completes the entire process of adding the reagent or dispensing as follows: moving to the suction reagent to absorb the reagent, then moving to the corresponding cleaning position for the outer wall cleaning, and then moving to the reagent addition direction
  • the reagent cup located in the reagent-adding position discharges the absorbed reagent, and finally moves to the corresponding cleaning position for cleaning the inner and outer walls.
  • the control reagent needle when the reagent needle is configured to continuously draw a plurality of reagents and then discharge together, the control reagent needle continuously performs a plurality of reagent aspiration operations to absorb the plurality of reagents required; wherein the absorption is required
  • the reagent needle is subjected to external wall cleaning, for example, at the reagent needle cleaning tank unit 61, after the completion of one aspirating reagent operation and before the start of the next reagent aspirating operation.
  • the reaction tray 4 is arranged in a disc-like structure, and the reaction tray 4 has a plurality of placement positions for placing the reaction cup, and the reaction tray can rotate and drive the reaction cup in the placement position to rotate the reaction cup in the reaction tray. And incubate the reaction solution in the cuvette.
  • the reaction disk 4 includes an inner ring portion and an outer ring portion that can be rotated independently or together; the inner ring portion includes one or more orbits, and each track is provided with a plurality of placement positions for the reaction cup.
  • the reaction disk 4 is one.
  • the reaction disk has a measurement position and/or a waste liquid level; the measurement position is used by the measurement unit 10 to determine the reaction cup, that is, the measurement unit 10 measures the cuvette that is dispatched to the measurement position, in one implementation.
  • the measuring position is photo-positioning; and the measuring cuvette in which the measurement is completed is sucked in the waste liquid level.
  • the measurement position and the waste liquid level are disposed on the outer circumference of the reaction disk 4, for example, the measurement position and the waste liquid level are all one placement positions on the outer circumference of the reaction disk 4.
  • the measurement bit 414 and the aspiration waste level 415 in FIG. The measuring reaction cup is taken up in the waste liquid level, and in an embodiment, the automatic analysis device further comprises a liquid suction unit 11 for sucking the reaction liquid in the measuring reaction cup, and sucking the waste liquid unit.
  • the movement path of the suction needle passes through the suction liquid level.
  • the reagent addition site is disposed in the reaction tray, ie, the reaction tray has a reagent addition site.
  • the reagent addition site is disposed on the outer circumference of the reaction disk 4, such as the reagent in FIG. Bit 412; in one embodiment, the addition is placed in or outside the reaction disk 4, such as the sample loading position 31 disposed outside of the reaction disk 4, as shown in FIG.
  • the mixing mechanism is used to mix the reaction liquid in the reaction cup that needs to be mixed.
  • the mixing mechanism is separately disposed outside the reaction disk 4.
  • the two mixing mechanisms can also be set to receive the cuvette in an odd cycle and receive the cuvette in an even number of cycles.
  • the mixing mechanism can perform a non-mixing operation, a short mixing operation, and a long mixing operation on the cuvette.
  • the measuring unit 10 is used for measurement of the reaction liquid to be tested.
  • the measuring unit 10 is a photo measuring unit, for example, detecting the luminous intensity of the reaction liquid to be tested, and calculating the concentration of the component to be tested in the sample by using a calibration curve.
  • the measuring unit 10 is disposed separately from the outside of the reaction disk 4.
  • the magnetic separation unit comprises a magnetic separation disk disposed in a disk-like configuration, the magnetic separation disk having one or more orbits of independent or simultaneous movement, each track including a plurality of placements for placing the cuvette
  • the magnetic separation disc is rotatable and drives the cuvette rotation in its placement position for scheduling the cuvette to the injecting and aspirating positions in the magnetic separation disc to complete the magnetic separation cleaning.
  • the magnetic separation unit is disposed separately from the outside of the reaction disk 4.
  • each of the magnetic separation units is disposed separately; or each of the magnetic separation units is coaxially and independently driven.
  • each magnetic separation unit receives the cuvette in a corresponding period.
  • the i-th magnetic separation unit corresponds to the receiving cuvette.
  • the period is the kN+i period, N is an integer greater than or equal to 2, k is an integer greater than or equal to 0, and i ranges from 1 to N, and i is an integer.
  • the period of the receiving cuvette corresponding to one magnetic separation unit is an odd cycle, and the other magnetic separation unit corresponds to The period of the receiving cuvette is an even period.
  • the magnetic separation unit performs a Y-order magnetic separation cleaning after receiving the cuvette, wherein Y is an integer greater than or equal to 1; for any one-stage magnetic separation cleaning, including: to the reaction cup The separation liquid is injected, and the reaction liquid in the reaction cup is magnetically separated and cleaned; the reaction cup is then aspirated to complete the magnetic separation cleaning of the present stage; the reaction cup for completing the Y-stage magnetic separation cleaning is waiting for the magnetic separation unit to be dispatched, for example When the magnetic separation cleaning is the non-final one of the multi-step test test items; or, the substrate is added to the reaction cup which completes the Y-stage magnetic separation cleaning, and waits for the magnetic separation unit to be dispatched.
  • FIG. 5 and FIG. 6 A specific mechanism structure of the magnetic separation unit of the present invention is given below.
  • a magnetic separation unit separated by a fourth-order cleaning may be taken as an example.
  • the figure includes a magnetic separation disk 901, a magnetic separation liquid absorption plate 902, a magnetic separation liquid injection plate 903, a magnetic separation disk drive motor 904, a magnetic separation liquid absorption plate upper and lower drive motor 905, a reaction cup mixing belt 906, and a magnetic separation chamber 907.
  • magnetic separation unit transfer operation position 911 first-order magnetic separation liquid suction needle 931, second-order magnetic separation liquid absorption needle 932, third-order magnetic separation liquid absorption needle 933, fourth-order magnetic separation liquid absorption needle 934, First-stage magnetic separation injection needle 941, second-order magnetic separation injection needle 942, third-order magnetic separation injection needle 943, fourth-order magnetic separation injection needle 944, substrate injection needle 945, magnetic separation injection Syringe, magnetic separation aspiration peristaltic pump, substrate injector, substrate injection valve, substrate bottle switching valve and substrate suction valve.
  • the reaction cup mixing belt 906 can simultaneously mix the second-stage injection, the third-order injection, the fourth-order injection and the substrate injection cup, and the magnetic separation chamber 907 is provided with a magnet as needed.
  • the substrate bottle can be a bottom puncture substrate bottle. Therefore, in an embodiment, the moving function component may be a magnetic separation disk drive motor 904, a magnetic separation liquid-absorption upper and lower drive motor 905, a reaction cup mixing belt 906, various stages of liquid suction needles, and various order injections. Needle, magnetic separation injection syringe, magnetic separation aspiration peristaltic pump, substrate injector 950, and the like.
  • the transfer mechanism is for scheduling the cuvette at least between the cuvette loading mechanism 1, the reaction disk 4, the mixing mechanism, and the magnetic separation unit.
  • the control unit is used to control at least the operation and timing of the sample dispensing mechanism 3, the reagent unit 5, the reagent dispensing mechanism 6, the reaction disk 4, the mixing mechanism, the measuring unit 10, the magnetic separation unit, and the transfer mechanism.
  • a one-step test project is used to explain the cooperation of the above-mentioned agencies, units, and the like.
  • the transfer mechanism dispatches a cuvette from the split cup position of the cuvette loading mechanism 1 to the loading position, and the sample dispensing mechanism 3 sucks the sample from the sample unit 33 and discharges it into the cuvette located in the sample loading position.
  • the sample loading position can be set in the reaction disk 1, that is, the sample loading position is a placement position in the reaction disk 1, and the sample loading position can also be disposed outside the reaction disk 1.
  • the transfer mechanism dispatches the reaction cup located at the sample loading position and the sample loading is completed to the reaction tray 1, and the reaction cup is discharged by the reagent dispensing mechanism 6 in the reaction tray 1. Then, the reaction cup is again dispatched from the reaction tray 1 to the mixing mechanism for mixing operation, and then the reaction cup is again dispatched from the mixing mechanism to the reaction tray 1 for incubation. After the reaction cup is incubated, the reaction cup is incubated. Then, the transfer mechanism is dispatched from the reaction disk 1 to the magnetic separation unit for magnetic separation cleaning. After the magnetic separation cleaning is completed, the reaction cup is dispatched from the magnetic separation unit by the transfer mechanism to perform final measurement.
  • the reaction disk 1 may have a measurement bit if The measuring unit 10 is a photometric unit, and accordingly the reaction disk 1 has a light positioning position.
  • the reaction cup is dispatched from the magnetic separation unit back to the reaction tray 1 by the transfer mechanism, and when the reaction tray dispatches the reaction cup 1 to its optical position, the photometric unit reacts the reaction.
  • the cup is lighted.
  • the reaction disk 4 has a reagent addition position at the outer ring portion, a first front operation position, a first rear operation position, and a second rear operation position at the inner ring portion, as described in detail below.
  • the first front operating position is used to receive the transfer mechanism to move the reaction cup from the split cup position to the reaction tray 4.
  • first The front operating position is used to receive the reaction cup from the sample loading position to the reaction cup of the reaction tray 4.
  • the first post operating position is for the transfer mechanism to dispatch the cuvette to the mixing mechanism or to receive the transfer cup from the magnetic separation unit to the reaction cup of the reaction tray.
  • the second post operating position is for the transfer mechanism to dispatch the cuvette to the magnetic separation unit.
  • the transfer mechanism may include a first gripper 2 and a second gripper 7.
  • the first gripper 2 is arranged to move the trajectory past the split cup position and the first front operating position, and when the loading position is outside the reaction tray 4, the movement trajectory of the first gripping cup 2 is further After the sample is added.
  • the second gripper 7 is arranged to pass the first rear operating position, the second rear operating position, the mixing mechanism and the magnetic separating unit.
  • the sample loading position When the sample loading position is located in the reaction tray 4, the sample loading position may be the same position as the first front operating position, or may be a different position; when the loading position is outside the reaction tray 4, the reagent position is added.
  • the first front operating position can be the same position or a different position.
  • the addition reagent position and the first front operation position are not the same position, for example, FIG. 4, from the viewpoint of the test flow of a one-step test item, each position is illustrated. Scheduling and coordination.
  • the first gripper 2 Under the control of the control unit, the first gripper 2 dispatches a cuvette from the split cup position of the cuvette loading mechanism 1 to the loading position 31, and the sample dispensing mechanism 3 draws the sample from the sample unit 33 and will absorb the sample. The sample is discharged to the cuvette on the loading position 31; the first gripper 2 then dispatches the refilled cuvette from the loading position 31 to the first pre-operating position 411 in the reaction tray 4, and the reaction tray 4 will The cuvette is dispatched from the first pre-operating position 411 to the reagent-adding position 412, and the reagent dispensing mechanism absorbs the reagent from the aspirating reagent position of the reagent unit 5 and then discharges to the reagent-adding position 412.
  • the reaction tray 4 then dispatches the reaction cup to the first post-operation position 413, and the second gripper 7 dispatches the cuvette from the first post-operation position 413 of the reaction tray 4 to the mixing mechanism for mixing operation.
  • the mixing mechanism for mixing operation For example, one of the mixing mechanisms 81, 82; after the mixing operation is completed, the second gripping cup 7 then dispatches the cuvette from the mixing mechanism to the second post-operation position 42 of the reaction tray for incubation; after the incubation is completed
  • the reaction tray 4 is scheduled in the reaction tray, the reaction cup is first dispatched to the second post-operation position 42, and then the second gripper 7 is used to the reaction cup.
  • the second gripper 7 then dispatches the cuvette from the magnetic separation unit To the first post-operation position 413 of the reaction tray; thereafter, during the predetermined substrate incubation time, the reaction tray 4 can just dispatch the reaction cup to the assay site 414 for determination by the assay unit 10; thereafter, the reaction tray 4 will be the reaction cup Dispatching from the measurement position 414 to the aspiration liquid level 415, aspirating waste liquid
  • the material 11 absorbs the waste liquid in the reaction cup at the waste liquid level 415, and the reaction tray 4 then dispatches the reaction cup from the waste liquid level 415 to the first pre-operation position 411, and the first gripper 2 then reacts the reaction.
  • the cup performs a cupping operation.
  • the first cup driver 2 discards the first front operating position 411 of the cuvette to one of the bowl holes 201, 202, and the bowl hole 201 communicates with a receiving device for loading the waste cup, for example
  • the waste bin 202 is also connected to a receiving device for loading the waste cup, and the control unit can control the first catcher 2 to discard the cuvette to be discarded from the first front operating position 411 to the throwing hole 201, when the cup hole 201
  • the control unit notifies the user to replace the containing device, and controls the first catcher 2 to discard the cuvette to be discarded from the first front operating position 411 to the bowling hole 202.
  • control unit in the automatic analysis device controls some units and mechanisms to perform corresponding operations in accordance with the timing.
  • the cycle mentioned above according to the operation of each unit and mechanism, for example, after the set period is a specific time, each unit and mechanism needs to complete a complete set of action flow in the unit time period.
  • the cuvette mechanism 1 For the cuvette device 1 to ensure that there is a cup in the cup at each cycle, for example, after the cup of the cycle cup is dispatched, the cuvette mechanism 1 will supply and carry a new cuvette to Cup position.
  • the reagent dispensing mechanism 6 needs to complete at least from the aspirating reagent to the adding reagent in one cycle.
  • the reaction cup completes a set of actions for discharging reagents.
  • the reaction tray 4 completes the preset number of rotations of the rotation in one cycle. For example, the reaction tray 4 has at least completed scheduling the reaction cup on the first front operation position 411 to the reagent addition position 413 in one cycle, and then The reaction cup with the added reagent is dispatched from the reagent addition position 413 to the first post operation position 413.
  • the mixing mechanism needs to complete the mixing operation in one cycle.
  • the measuring unit 10 completes the measuring operation in one cycle.
  • each magnetic separation unit needs to advance a cup position in N cycles, for example, rotating the cuvette in its placement position to the next adjacent placement position.
  • each magnetic separation unit needs to advance one cup position in two cycles.
  • the suction and waste liquid unit 11 completes the operation of sucking the waste liquid to the reaction cup of the waste liquid level.
  • the transfer mechanism is used to schedule the cuvettes in accordance with the cycle of each mechanism and unit.
  • the automatic analysis device in Fig. 4 can achieve the shortest cycle of 7.5 seconds in the industry, and the test speed is also very fast and improved.
  • the cuvette device mechanism 1, the first gripper 2, the sample dispensing mechanism 3, the reaction tray 4, the reagent unit 5, the reagent dispensing mechanism 6, the second gripper 7, the mixing mechanism 81 and 82, and the measurement The period of the unit 10 and the waste absorbing unit 11 is 7.5 seconds. Since the two magnetic separation units 91 and 92 are included, each magnetic separation unit can receive one cuvette 15 seconds apart and advance one cup position, so the actual duty cycle of each magnetic separation unit is 15 seconds; At this time, it is a magnetic separation unit, and the period of the magnetic separation unit is also 7.5 seconds.
  • FIG. 4 can include two independently operating magnetic separation units 91 and 92, one receiving the cuvette in an odd cycle and one receiving the cuvette in an even number of cycles, there is no fixed working step limitation, which can be used for the first One-step magnetic separation cleaning can also be used for the second magnetic separation cleaning, which greatly improves the testing speed and test throughput of the whole machine.
  • the above is a working method after a failure occurs for a plurality of magnetic separation units in an embodiment of the present invention.
  • there are also two magnetic separation units one of which is to implement a two-step test.
  • Two units are arranged on the test flow.
  • the two magnetic separation units can only perform the first step of magnetic separation or the second step of magnetic separation.
  • the function of each unit is limited by the whole machine scheme and cannot be flexibly called in the test sequence. It has no effect on improving the test speed, and it is impossible to realize the working mode of single magnetic separation; the other is the technical scheme adopted by the electrochemiluminescence analyzer, which uses two sets of electrochemical measurement modules, but due to electrochemiluminescence measurement
  • the uniqueness of the quantity principle can only support the test of magnetic separation once.
  • the measurement module has the function of magnetic separation and metering.
  • the test entering the module will not be able to return to the test sequence again without any flexibility.
  • the multiple magnetic separation disk schemes employed by the present invention are not only critical to the speed of testing, but their flexibility and interchangeability are not achievable by other solutions.
  • the working method further comprises: performing a Y-order magnetic separation cleaning on the cuvette after receiving the cuvette, wherein Y is an integer greater than or equal to 1; for any certain order of magnetic separation cleaning, including Adding the separation liquid to the reaction cup, magnetically separating and cleaning the reaction liquid in the reaction cup; then aspirating the reaction cup to complete the magnetic separation cleaning of the current stage; completing the reaction cup of the Y-stage magnetic separation cleaning waiting for the magnetic discharge
  • the separation unit or, adds a substrate to the cuvette that completes the Y-stage magnetic separation cleaning, and waits for the magnetic separation unit to be dispatched.
  • the magnetic separation cleaning of the one-step test project and the magnetic separation cleaning of the last step of the multi-step test project need to be added to the substrate because the next process of the reaction cup is determined, for example, by the photometric unit in the optical position For optical measurement; other magnetic separation cleaning, such as multi-step test, does not include any of the other step tests, such as the last one-step test, the magnetic separation does not require the addition of substrate after cleaning, so the reaction cup is still To perform a subsequent step test.
  • FIG. 7 is a diagram of a fourth-order magnetic separation disk of the magnetic separation unit of FIG.
  • the cup position in Table 1 refers to the placement position on the magnetic separation disk for placing the cuvette.
  • the invention matches the test period of other units and mechanisms by at least two magnetic separation discs, thereby improving the test speed and the reliability of the whole machine.
  • the present invention introduces a corresponding fault detection mechanism and a working method related to fault detection by the at least two magnetic separation discs, so that when one or more magnetic separation units fail, the automatic analysis device can continue to work. For example, a magnetic separation unit that is not marked as faulty continues to operate while other units and mechanisms in the automated analysis device adjust the duty cycle to match the magnetic separation unit that is not marked as faulty.
  • the program may be stored in a computer readable storage medium, and the storage medium may include: a read only memory, a random access memory, a magnetic disk, an optical disk, a hard disk, etc.
  • the computer executes the program to achieve the above Features.
  • the program is stored in the memory of the device, and when the program in the memory is executed by the processor, all or part of the above functions can be realized.
  • the program may also be stored in a storage medium such as a server, another computer, a magnetic disk, an optical disk, a flash disk or a mobile hard disk, and may be saved by downloading or copying.
  • the system is updated in the memory of the local device, or the system of the local device is updated.

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Abstract

L'invention concerne un appareil d'analyse automatique et un procédé de fonctionnement pour l'appareil d'analyse automatique. Au moins deux unités de séparation magnétique (91, 92) sont mises en correspondance avec des cycles de fonctionnement d'autres unités et mécanismes, de façon à augmenter la vitesse d'essai et la fiabilité de l'appareil d'analyse automatique. Par ailleurs, un mécanisme de détection de panne correspondant est introduit et le procédé de fonctionnement de l'appareil d'analyse automatique est lié à une détection de panne, de telle sorte que lorsqu'une ou plusieurs des unités de séparation magnétique (91, 92) sont en panne, l'appareil d'analyse automatique peut continuer à fonctionner. Par exemple, les unités de séparation magnétique (91, 92) non marquées comme étant en panne continuent de fonctionner, et les cycles de fonctionnement des autres unités et mécanismes dans l'appareil d'analyse automatique sont ajustés pour se coordonner avec les unités de séparation magnétique (91, 92) non marquées comme étant en panne.
PCT/CN2017/102536 2017-09-20 2017-09-20 Appareil d'analyse automatique et son procédé de fonctionnement WO2019056235A1 (fr)

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CN201780094103.0A CN111033266B (zh) 2017-09-20 2017-09-20 一种自动分析装置及其工作方法

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