Automatic analyzer and method

Abstract

To provide an automatic analyzer capable of discriminating whether the end state of measurement is normal or abnormal with a simple configuration, and thereby shortening the rise time from start to start of measurement.SOLUTION: An automatic analyzer comprising device elements for measuring a target component in a sample by operating consumables such as a sample, a reagent, a reaction vessel, etc., comprises: a state flag for mechanically storing two states; and a control unit for setting the state flag to a first state when starting the measurement and setting the state flag to a second state when finishing the measurement.SELECTED DRAWING: Figure 8

Description

[Technical field]

[0001] The present invention relates to an automatic analyzer used in clinical testing, and a method for using the same to shorten the start-up time after the device is started. [Background technology]

[0002] In recent years, in the field of clinical testing, automated analyzers have become known that can quantitatively or qualitatively measure specific components in samples by mixing samples such as human blood with a specified reagent and then measuring the sample. In particular, point-of-care testing (POCT), which allows for simple and rapid test results, is becoming more and more popular.

[0003] Reagents used in automated analyzers are often contained in dedicated containers called reagent cartridges. Typically, a reagent cartridge has multiple wells, and in addition to the reagents, it contains dispensing tips for dispensing samples and reagents, and a hole punch (perforation tip) for punching holes in the film of the reagent wells. When measuring a sample using an automated analyzer, attachments such as the dispensing tip and hole punch are attached to the movable dispensing nozzle base connected to the suction and exhaust pipe, and a controlled measurement operation proceeds.

[0004] However, if the measurement ends abnormally due to a momentary power interruption or the like, the attachment remains attached to the dispensing nozzle base. When turning on the power to the device to restore it, it is necessary to carry out a start-up operation that takes into account the possibility of abnormal termination with the attachment remaining attached to the dispensing nozzle base. However, in the case of normal termination without power interruption during measurement, the start-up operation is unnecessary, and takes time.

[0005] If the device can store which process it has finished at, it can distinguish between normal (also called normal) and abnormal terminations when the power is turned on, and this can reduce time. As a method for storing processes, for example, there is a method of storing the process in a NAND-type flash memory, which is a non-volatile semiconductor memory, but (1) there is an upper limit to the number of times it can be rewritten, and (2) there is a possibility that multiple program files may be destroyed during rewriting due to a momentary power interruption or the like. Regarding (1), if rewriting and erasure are concentrated in a specific block of the flash memory, the block will deteriorate quickly, so as a countermeasure, Patent Document 1 discloses a wear leveling method for leveling out rewriting within the flash memory. Regarding (2), Patent Document 2 discloses a method of holding files to be rewritten when rewriting the flash memory in a separate storage area of ​​the flash memory as a control method of the NAND-type flash memory that takes into account file protection in the event of a sudden power outage. However, considering that these designs are implemented in a POCT device with a simple configuration, the design difficulty is high, and the incorporation of a flash memory increases costs. Although it is not process memory, there is also a method of sensing the attachments at the base of the dispensing nozzle, but dispensing tips and the like are often made of translucent resin, which makes them difficult to detect both optically and electromagnetically. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] JP 2022-186582 A [Patent Document 2] JP 2020-181325 A Summary of the Invention [Problem to be solved by the invention]

[0007] To provide an automatic analyzer capable of determining, with a simple configuration, whether the end state of the previous measurement was normal or abnormal, and thereby shortening the start-up time from startup until the start of the next measurement. [Means for solving the problem]

[0008] The present invention is an automatic analyzer equipped with device elements for measuring a target component in a sample by manipulating consumables such as a sample, a reagent, and a reaction vessel, and has the following features. In order to determine whether the end state of the measurement was normal (called "normal end") or abnormal (called "abnormal end"), a status flag is provided to mechanically store two states. Here, "mechanically store" means that the position information, arrangement information, or displacement information of the device element used in the measurement or a newly installed mechanical member is treated as an identifier. Since it is sufficient to express and identify two states in order to store them in the status flag, a combination of members that slide, rotate on an axis, or come into contact and separate from each other can be used as a storage medium. The two states indicated by the status flag can also be an index of whether the position information of a specific device element matches a reference position. The specific device element can also be a plunger that reciprocates in a syringe means that draws in and discharges liquid. When reading out the status flag, an optical sensor combining a light emitting element and a light receiving element may be used to detect the relative position information of the mechanical components, or a capacitance sensor or an electrical conductivity sensor may be used to directly detect the contact / separation state between the components. Mechanically stored information has the characteristic that it can be robustly retained even in the event of a sudden power outage. When identifying the status flag, a state where the reference relative position is not matched or separated may be treated as a first state (which may be called an OFF state), and a state where the reference relative position is matched or contacted may be treated as a second state (which may be called an ON state). In some cases, the first state may be called an ON state, and the second state may be called an OFF state. The control unit sets the status flag to the first state when starting a measurement. It executes the measurement operation in that state, and sets the status flag to the second state when the measurement is completed. If some abnormal event occurs and the device stops before the status flag is transitioned to the second state, the status flag will remain in the first state. In this way, the next time the device is started, a simple and effective means is obtained that can determine whether the previous measurement ended normally if the end state is read as the second state, or whether it ended abnormally if the end state is read as the first state.

[0009] In the present invention, the start of measurement may be interpreted as the time from when the power supply of the device is turned on through pre-measurement preparation operations to the start of the operation of measuring the first specimen or standard sample, and the end of measurement may be interpreted as the time when the measurement of the last sample is completed. Alternatively, in batch measurement in which the measurement of one or more samples is started simultaneously and no additional samples are introduced into the device until the measurement is completed, the start and end of measurement can be defined for each batch.

[0010] During measurement, if the measurement ends abnormally, for example, when the dispensing tip is attached to the base of the dispensing nozzle, or when the sample is not sealed in the reaction vessel, these states are saved when the device is started next time, so a pre-processing operation must be performed to restore these states to normal before starting a new measurement. On the other hand, if the device power is turned off in a state where the measurement has ended normally, that is, when consumables have been removed from the device elements and / or when a liquid containing a sample is sealed in a reaction vessel, the above pre-processing is not necessary. In such cases, the present invention can determine whether the measurement ended normally or abnormally, so that the pre-processing step can be omitted when it is not necessary. If the pre-processing step, which is performed on the assumption that the device ended abnormally the previous time it was operated, was performed every time the power was turned on, the time required for the measurement preparation operation can be saved compared to that case. Effect of the Invention

[0011] The present invention provides an automatic analyzer that can determine whether the end state of a measurement was normal or abnormal and can rationally shorten the start-up time after the device is started up, and a method for using the same to shorten the start-up time after the device is started up. [Brief description of the drawings]

[0012] [Figure 1] FIG. 1 is a conceptual configuration diagram of the present invention. [Diagram 2] 2 is a flowchart showing the overall operation of the present invention. [Diagram 3] 1 is a configuration diagram showing an automatic analyzer according to an embodiment. [Figure 4] FIG. 4 is a diagram showing the reagent cartridge according to the embodiment of FIG. 3. [Diagram 5] 4 is a diagram showing a measurement operation according to the embodiment of FIG. 3. [Figure 6] 13 is a flowchart showing a standing-up operation when an attachment is present. [Figure 7] FIG. 13 is a diagram showing the reagent cartridge after a start-up operation is performed when an attached object is present; [Figure 8] FIG. 13 is a diagram showing a method of driving the syringe to store whether or not an abnormal termination has occurred. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] Hereinafter, an embodiment of the present invention will be described with reference to the accompanying drawings. A specific embodiment will be described, but the present invention is not limited to this example, and it is easily understood by those skilled in the art that various modifications are possible within the scope of the invention described in the claims. FIG. 1 is a conceptual configuration diagram of an automatic analyzer 100 according to the present invention. The diagram shows a combination of an apparatus element 101 for measuring a target component in a sample, a status flag 102 using the apparatus element 101, a light projecting element 103 and a light receiving element 104 for detecting the state of the status flag 102, and a control unit 105 for controlling the above apparatus elements and setting the state of the status flag. In the diagram, the status flag 102 can move back and forth from side to side, and the control unit 105 distinguishes between two states depending on whether the protruding state of the status flag 102 passes or blocks the beam from the light projecting element 103. Note that the detection configuration is merely an example.

[0014] FIG. 2 explains the operation flow of the control unit in the present invention, taking batch measurement as an example. After the device is powered on (S1), it is determined whether the status flag is ON (S2). Here, the ON state indicates that the previous measurement was completed normally. Therefore, if the result is NO, i.e., OFF, in step S2, it indicates that the previous measurement was completed normally, so the abnormal startup operation is performed in step S4. If the result is YES, i.e., ON, in step S2, it indicates that the previous measurement was completed normally, so the normal startup operation is performed (S3). The normal startup operation is a preparatory operation before measurement that consists of fewer steps than the abnormal startup operation. After S3 or S4 is performed, the status flag is set (transitioned) to ON (S5). After this step S5, if the device abnormally ends during measurement, the device will be restarted (next startup) with the status flag mechanically stored in the OFF state. Now, in the measurement, the flag is set to OFF immediately after the measurement starts (S6, 7), and the measurement ends when the flag is set to ON after the measurement operation is completed (S8-10). If there are any remaining batches to be measured, step S11 will be YES, and the process will return to step S6. If it is determined that there are no remaining batches to be measured (NO in S11), the process will proceed to shutting down the power to the device (S12). If there are any processes to be performed before shutting down the power to the device, it is preferable to set the flag to ON after the processes are performed. Next, the embodiment will be illustrated more specifically. FIG. 3 is a configuration diagram of an automatic analyzer 1 according to an embodiment of the present invention. Note that the control unit is omitted. The dispensing mechanism 2 includes a dispensing probe 20 (the dispensing nozzle base is also called the dispensing probe), a dispensing probe driving unit 21, a piping tube 30, a syringe 40, and a syringe driving unit 43. The dispensing probe 20 can be moved in the Z direction by the dispensing probe driving unit 21, and a disposable dispensing tip 52 and a seal breaker 63 can be attached and detached to the tip. When the dispensing probe 20 is lowered from directly above the dispensing tip 62 and the seal breaker 63, the dispensing tip 62 and the seal breaker 63 are attached, respectively. Then, when the dispensing probe 20 is raised, the dispensing tip 62 and the seal breaker 63 are removed from the test cartridge 50. The dispensing probe 20 is also connected to the suction and discharge mechanism of the syringe 40 by a tube 30. A set amount of sample or reagent is aspirated and dispensed into the dispensing tip 10 by moving the plunger 42 in the cylinder 41 in and out using the syringe drive unit 43. The test cartridge 50 used in this embodiment is loaded into an incubator 70. The incubator 70 can be moved in the Y direction by an incubator drive unit 71.

[0015] 4 shows the test cartridge 50 used in this embodiment. It has four wells, with a sample 61 stored in well 51, a dispensing tip 62 stored in well 52, a seal breaker 63 stored in well 53, and a reagent 64 stored in well 54 (reaction vessel). Well 54 is sealed with a sealing film 65. The dispensing tip 62 is attached to the dispensing probe 20 and is used to dispense or stir the sample or reagent. The seal breaker 63 is attached to the dispensing probe 20 and is used to open the sealing film 65 of well 54 or to seal well 54.

[0016] FIG. 5 shows the flow of operations performed on the test cartridge in the device during the measurement operation. The test cartridge is moved so that the well 53 of the test cartridge is located directly below the dispensing probe 20 in the Z direction (hereinafter, the position directly below the dispensing probe in the Z direction is referred to as the dispensing position) (FIG. 5(a)). A seal breaker 63 is attached to the dispensing probe 20, and the seal breaker 63 is lowered against the sealing film 65 of the well 54 to form a hole for dispensing (FIG. 5(b)). Next, a dispensing tip 62 is attached, and a certain amount of the sample contained in the well 51 is aspirated (FIG. 5(c)). The sample is discharged into the well 52 (FIG. 5(d)), and the sample is heated for a certain period of time (FIG. 5(e)). After heating, the sample is transferred to the well 54, and the sample is mixed with the reagent by repeating the aspirating and dispensing (FIG. 5(f)). After mixing, a seal breaker 63 is attached to the dispensing probe 20, and the well 54 is sealed with the seal breaker 63. Thereafter, a reaction proceeds in the well 54, and the increase in the reaction product is measured (FIG. 5(g)). After the measurement is completed, the seal breaker 63 is removed from the dispensing probe 20 (FIG. 5(h)). The measurement ends with the well 54 sealed with the seal breaker 64. Sealing with the seal breaker 64 prevents the sample in the well 54 from scattering if the user accidentally tips over the test cartridge 20.

[0017] If the device is abnormally terminated due to a momentary power interruption during a measurement operation, the dispensing tip 62 or the seal breaker 63 may be attached to the dispensing probe 20 depending on the timing of the measurement operation. Therefore, when turning on the power to the device and starting it up, the start-up operation must be performed taking into consideration that an attachment is attached to the dispensing probe 20. Furthermore, if a measured sample that should not be exposed to the environment is contained in the well 54, it is preferable to seal the well 54 with the seal breaker 63. Therefore, in the start-up operation, it is necessary to accommodate the dispensing tip 62 in any of the wells of the test cartridge 20 that can accommodate the wells, and seal the well 54 with the seal breaker 63 so that the dispensing tip 62 or the seal breaker 63 is not left in the device while still attached to the dispensing probe 20. 6 shows a flow of the startup operation taking into consideration that an attachment is attached to the dispensing probe 20. First, the dispensing probe 20 is raised (S101). Next, the well 51 is moved to the dispensing position (S102). The dispensing probe 20 is lowered and an attachment removal operation is performed (S103, S104). The dispensing probe 20 is raised and the well 53 is moved to the dispensing position (S105, S106). The dispensing probe 20 is lowered to the height at which the seal breaker 63 is attached (S107). The dispensing probe 20 is raised and the well 54 is moved to the dispensing position (S109). The dispensing probe 20 is lowered to the height at which the well 54 is sealed (S110). An attachment removal operation is performed and the dispensing probe 20 is raised (S111, S112). For example, when the power supply is cut off in the states (b), (c) to (f), and (g) of FIG. 4, the startup operation shown in FIG. 6 is performed, resulting in the states (b), (cf), and (g) of FIG. 7, respectively.

[0018] However, if it is possible to store whether the measurement ended abnormally during measurement or ended normally other than during measurement, it is possible to shorten the start-up time by determining whether the measurement ended normally or abnormally, and performing the start-up operation considering that the attachment shown in FIG. 6 is attached only in the case of abnormal end, and not performing the start-up operation in the case of normal end. This is as described above with reference to FIG. 2. As a method for storing whether the measurement ended abnormally during measurement, a method of storing the information by using a home sensor 45 of a drive shaft for relative movement such as the syringe 40 is shown. The home sensor is a position sensor for confirming whether the drive member is at a displacement position (home position) that is a reference in the drive unit. For example, a mark (called a sensor flag) is fixed at a predetermined position of the drive member, and when the home sensor detects this sensor flag, it is said that the drive member is at the home position. FIG. 8(a) shows the state of the syringe 40 when not in measurement. The home sensor 45 detects the sensor flag 44 and is in the "ON" state. FIG. 8(b) shows the state of the syringe 40 immediately after the start of measurement. Immediately after the start of measurement, the plunger 42 is moved a certain distance, and the home sensor 45 is in the "OFF" state. FIG. 8(c) shows the state of the syringe 40 during measurement. When performing an aspiration and discharge operation during measurement, the sensor flag 44 is moved relatively to a position where it is out of contact with the home sensor 45. Therefore, the home sensor 45 is always in the "OFF" state during measurement. Then, at the end of measurement, the plunger 42 is returned to the home position, and the home sensor is turned "ON". As shown in FIG. 8, by moving the plunger 42 relatively to the home sensor 45 during measurement while it is out of contact with the home sensor 45, the home sensor 45 is turned "OFF" during measurement and turned "ON" except during measurement. Therefore, when the power is turned on to the device, the state of the home sensor 45 of the syringe 40 is monitored, and if it is "OFF", it is possible to determine that the measurement has ended during measurement (abnormal end), and if it is "ON", it is determined that the measurement has ended except during measurement (normal end). [Explanation of symbols]

[0019] 1,100 automatic analyzer 2 Dispensing mechanism 20 Dispensing Probe 21 Dispensing probe drive unit 30 Piping Tube 40 Syringe 41 Cylinder 42 Plunger 43 Syringe drive unit 44 Sensor Flag 45 Home Sensor 50 Test Cartridges 51, 52, 53, 54 wells 61 Samples 62 Dispensing Tips 63 Seal Breaker 64 Reagents 65 Sealing film 70 Incubator 71 Incubator drive unit 101 Equipment elements 102 Status Flags 103 Light emitting element 104 Photodetector 105 Control section

Claims

1. An apparatus element for measuring a target component in a sample; A status flag that utilizes the device element; An automated analyzer comprising a controller that controls the device elements and sets the state of the status flag.

2. the status flag is a status flag that mechanically stores two different states, a first state and a second state, the control unit sets the status flag to a first state when starting measurement, and sets the status flag to a second state when ending measurement; In the second state, At least the batch measurement has been completed, or A state in which consumables have been removed from the device components and / or a liquid containing a sample has been sealed in a reaction vessel; The automated analyzer of claim 1.

3. The first state and the second state are determined based on whether or not position information of a specific device element matches a reference position; 3. The automatic analyzer according to claim 2, wherein a state where the relative positions of the reference are not aligned or separated is defined as a first state, and a state where the relative positions of the reference are aligned or contacted is defined as a second state.

4. 4. The automatic analyzer according to claim 3, wherein said position information is detected by an optical sensor comprising a combination of a light emitting element and a light receiving element.

5. 4. The automatic analyzer according to claim 3, wherein said specific device element is a plunger that reciprocates in a syringe means for aspirating and discharging liquid.

6. The automatic analyzer according to any one of claims 1 to 5, wherein when the control unit determines that the status flag is in a second state when the automatic analyzer is powered on, the control unit omits a pre-processing process that is performed on the assumption that the automatic analyzer terminated abnormally the previous time it was operated.

7. The automatic analyzer according to any one of claims 1 to 5, wherein when the control unit determines that the status flag is in a first state when the automatic analyzer is powered on, the control unit performs a pre-processing process assuming that the automatic analyzer terminated abnormally the previous time it was operated.

8. The automated analyzer according to claim 5 , wherein the pretreatment step is a step of removing consumables from the device elements and / or a step of sealing a reaction vessel.

9. A method for shortening the start-up time after starting up an automatic analyzer according to any one of claims 1 to 8.

10. Turning on the device power supply to start the device; Detecting a status flag through a control unit to determine a status; performing a normal start-up operation when the second state is detected, and performing an abnormal start-up operation when the first state is detected, The method of claim 9 , wherein the normal start-up operation is configured to have fewer steps than the abnormal start-up operation.

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