JP2010261823A - Automatic analyzer - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To allow a reagent vessel in a better state to be chosen from among a plurality of reagent vessels hooked in an apparatus on the basis of respective accuracy control results, and the like, to thereby to improve the reliability of measurements. <P>SOLUTION: An automatic analyzer is provided which houses the plurality of reagent vessels to be used for the same measurement item; dispenses a reagent in a prescribed reagent vessel; brings the reagent to react with a specimen and analyzes the characteristics of a reaction liquid. In the automatic analyzer, the reagent vessels are controlled individually, and the reagent dispensation of each reagent vessel can be decided arbitrarily by an operator, or a control range is set by the operator, about a measurement value of an accuracy control substance, a calibration coefficient, a reagent blank absorbance in a calibration operation, and the like. The automatic analyzer includes a means which makes a decision regrading the advisability of the analyzer for the control range and automatically determines the priority of using the reagent vessels. Information regarding the usage condition and the usage priority of the reagent vessels is shared by the inspection system as a whole, among analysis modules or among analyzers. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to an automatic analyzer that analyzes biological samples such as blood and urine, and more particularly to an automatic analyzer that includes a reagent container mounting mechanism that can mount a plurality of reagent containers for the same item.

  A so-called pipetter-type automatic analyzer, equipped with a reagent placement mechanism that mounts reagents corresponding to multiple analysis items, and dispenses different reagents for each analysis item using a common reagent dispensing mechanism. It is the mainstream of current automatic analyzers because it is suitable for analysis of

  In such an automatic analyzer of the pipetter method, if the reagent corresponding to one analysis item is insufficient, the analysis item cannot be analyzed until the reagent is replaced. Regarding the reagent, Patent Document 1 describes a system in which a plurality of sets of reagents for the same item are mounted. In the automatic analyzer described in Patent Document 1, when the remaining amount of the first reagent container is insufficient, the reagent is automatically dispensed from the second reagent container for the same item. The measurement can be continued without replacing.

  Furthermore, in the automatic analyzer described in Patent Document 2, as in Patent Document 1, a plurality of sets of reagents for the same item are mounted, and control is performed so that old reagents are used from a reagent container with a small remaining amount. In addition to preventing the inconvenience of remaining, it is possible to obtain an effect that an operator does not need troublesome operations such as exchanging the positions of the reagent containers or instructing the order of use in order to determine the order of use of the reagents.

Published Utility Heisei 2-99351 JP 9-43244 A

  In order to guarantee the measurement accuracy, the automatic analyzer periodically measures a sample whose concentration is known in advance called a quality control sample. For example, if a sample or reagent dispensing mechanism malfunctions and a predetermined amount of sample or reagent cannot be dispensed or the reagent deteriorates, the measurement result of the quality control sample will fluctuate. Is recognized by the operator. In an automatic analyzer equipped with a plurality of sets of reagents for the same analysis item as described in Patent Documents 1 and 2, even if reagent deterioration occurs, the position of the reagent container, the remaining amount of reagent, Alternatively, the order of use is uniquely determined based on instructions from the operator. If it is known in advance that the reagent has deteriorated based on the measurement result of the quality control sample, if the device can be automatically controlled so that the deteriorated reagent is not used, an incorrect measurement result is reported. You can avoid that.

  An object of the present invention is to provide an automatic analyzer capable of mounting a plurality of sets of reagents for the same item so that an unexpected measurement abnormality does not occur even when the reagent container is switched.

  The automatic analyzer according to the present invention is configured as follows.

  In an automatic analyzer that accommodates a plurality of reagent containers of the same measurement item, dispenses the reagent in a predetermined reagent container, reacts the reagent with the sample, measures the characteristics of the reaction solution, and analyzes the sample. The reagent containers are individually managed, and the operator can arbitrarily determine the reagent dispensing from each reagent container.

  Alternatively, the operator sets the management range for the measurement value of the quality control substance, the reagent blank absorbance at the time of calibration, the calibration coefficient, etc., the device determines whether or not the control range is appropriate, and sets the priority for using the reagent container. A means for automatically judging is provided.

  Information on the usage priority and usage status of the reagent containers is shared between the entire inspection system, analysis modules, and apparatuses.

  According to the present invention, it is possible to improve the accuracy of measurement values. In addition, it is possible to prevent a stagnation of the system and build a quick inspection system.

The basic structure figure which shows the outline of an analyzer. Reagent management range setting screen when the reagent is automatically managed by the device. The example of a reagent priority order judgment factor setting screen in case an apparatus performs reagent management automatically. The reagent priority order determination flowchart in case an apparatus performs reagent management automatically. The example of the priority determination by a reagent priority determination flowchart. Screen example when the operator sets the order in which reagent containers are used. The example of the screen which displays a calibration result and a bounce measurement value. The model figure of the system which shares reagent container information. Screen example 1 for displaying measured values of quality control substances. Screen example 2 that displays measured values of quality control substances.

1. Based on the measured value of the quality control sample, calibration result, and calibrator return value, the operator is in better condition with the waiting reagent than the currently used reagent. There is a case where it is determined that the analysis of
2. In the conventional device, after measuring other requested items without measuring the item that uses the reagent, you must follow the procedure such as measuring the reagent after replacing the item and reporting the result. Contributed to the delay in reporting.
3. In addition, when there is a waiting reagent, the waiting reagent is automatically used when the remaining amount of the reagent currently in use becomes 0, but in order not to use the reagent in the waiting reagent container for the analysis, Since it was necessary to replace the container, it was necessary to stop the apparatus, and the user was burdened with time and effort.
4). Furthermore, quality control substances are generally measured not only before the start of sample measurement but also during sample measurement, but if the quality control substance measurement value exceeds the control range during the day measurement Even for specimens measured before that time, it was necessary to perform re-measurement to ensure the accuracy of the data.

  The present invention solves the above problems.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings.

  First, a configuration example of an automatic analyzer will be described with reference to FIG.

  In this apparatus, a plurality of sample cups 1 can be installed, a sample disk 2 having a function of moving to a collection position, a sampling mechanism 3 for collecting a predetermined amount of sample, a reagent pipetting mechanism 4 for dispensing a plurality of reagents, and a reagent container 5 A reagent disk 6 having a function of moving a plurality of tubes to a dispensing position, a reader 7 for recognizing an identifier attached to the reagent container, a reaction disk 9 holding a plurality of direct photometric reaction containers 8, a stirring mechanism 10, A reaction vessel cleaning mechanism 11, a photometer 12, a central processing unit (microcomputer) 13 for controlling the entire mechanism system are mainly configured.

  The central processing unit (microcomputer) 13 further stores an operation unit 14 having an input / output device for inputting necessary information, a display unit 15 such as a monitor or printer for displaying analysis results, and analysis conditions and measurement results. A storage unit 16 is connected. The monitor may also serve as the operation unit 14 and the display unit 15.

  In some cases, a plurality of units such as the automatic analyzer 17a having the above-described configuration and the other automatic analyzer 17b function in cooperation with each other and connected to a host system 18 for management.

  Next, the implementation method of quality control measurement is shown.

(1) Reagent registration The reagent container 5 is set on the reagent disk 6.

  An identifier such as a barcode is attached to the reagent container 5. Information obtained from this identifier includes item name, reagent production lot number, reagent expiration date, reagent container size, reagent container sequence number, and the like.

  Based on the information on the reagent container 5 read by the reading device 7 and the information on the position where the reagent container is installed, the information on the reagent container 5 stored in the apparatus main body or the host system 18 of the inspection system is called and loaded. The information about the reagent container 5 is stored in the storage unit 16 and output to the display unit 15.

(2) Specification of quality control The operator uses the monitor, keyboard or floppy (registered trademark) disk to specify the quality control items and the quality control sample used for quality control. The information is stored in the storage unit 16 and output to the display unit 15.

(3) Execution of calibration The operator stores items to be calibrated, a calibrator, and a reagent container to be measured in the storage unit 16 using a monitor, a keyboard, or a floppy (registered trademark) disk in the same manner as the accuracy control.

  The operator places the calibrator in the sample cup and sets it on the sample disk.

  When the calibrator measurement start is designated, the computer controls the apparatus according to the stored information, dispenses the calibrator designated in the reaction container and the reagent in the reagent container, reacts them, and performs photometry.

  When measurement is specified for a plurality of reagent containers in the same item, measurement is performed for all of these containers.

  The measurement result and the measured reagent container information are stored in the storage unit 16 and output to the display unit 15.

(4) Reciprocal measurement of calibrator The operator monitors the items to be measured, the calibrator, and the reagent container 5 to be measured for reciprocating the calibrator (the work of measuring the calibrator used for calibration as a general sample and checking the concentration value). , Using a keyboard or a floppy (registered trademark) disk, and stored in the storage unit 16.

  The number of strike-back measurements is preset or set by the operator.

  The operator places the calibrator in the sample cup 1 and sets it on the sample disk 2.

When the start of the calibrator reversal measurement is instructed, the central processing unit (microcomputer) 13 controls the apparatus according to the stored information, and dispenses the designated calibrator and the reagent in the reagent container 5 to react. Measure the light. When measurement is specified for a plurality of reagent containers 5 in the same item, measurement is performed for all of the containers.
This measurement result and information of the measured reagent container 5 are stored in the storage unit 16 and output to the display unit 15.

(5) Execution of quality control substance measurement The operator places a quality control sample in the sample cup 1 and sets it on the sample disk 2.

  When the quality control start is designated, the central processing unit (microcomputer) 13 controls the device in accordance with the stored information, and dispenses the designated quality control sample and the reagent in the reagent container 5 to react. And meter the light.

  When the measurement of the standard solution performed before the quality control measurement is performed on a plurality of reagent containers 5 of the same item, the quality management measurement is performed for each reagent container 5.

  The result is combined with information included in the identifier of the reagent container 5, stored in the storage unit 16 for each reagent container, and output to the display unit 15.

  An embodiment of the present invention in such an automatic analyzer will be described below.

  FIG. 2 shows an example of the reagent management range setting screen in the first embodiment when the apparatus judges and registers because it is outside the reagent management range. The management range of the reagent is registered in advance by the operator from the operation screen of the automatic analyzer.

  The reagent management range is set on the reagent management range setting screen displayed on the operation screen.

  The setting screen displays the analysis items in the automatic analyzer, and each process such as reagent registration, calibration, repetitive measurement, and quality control substance measurement exceeds a specific numerical range or a specific numerical value, or Enter as a size below.

  The numerical value indicates the concentration, activity value, absorbance, number of days elapsed since opening of the reagent container, number of samples, absorption wavelength, and the like.

  Furthermore, a priority order determination factor, which is an element for determining the priority order, is set for the reagent containers adapted within the management range.

  FIG. 3 shows an example of the setting screen for the priority determination factor.

  FIG. 4 shows an example of the reagent priority determination flow of the apparatus in the first embodiment when the apparatus determines and registers because it is out of the reagent management range.

  After the start of the reagent priority order determination flow, STEP1 reagent registration is performed, and information such as the current usage status, how many days have passed since opening, the number of remaining valid tests, and the number of days remaining until the expiration date is registered.

  From the information obtained in STEP1, STEP2 provisional priority determination is performed.

  Proceeding to STEP 3 calibration, it is determined whether the STEP 4 calibration data is within the reagent management range.

  Proceeding to STEP 5 repetitive measurement, it is determined whether or not STEP 6 repetitive measurement data is within the reagent management range.

  STEP 7 quality control substance measurement is performed, and it is determined whether or not the STEP 8 measurement data is within the set management range.

  The process proceeds to STEP 9 priority determination, and priority determination is performed using a preset priority determination factor.

  Since the quality control substance is measured not only at the start of work but also during the sample measurement of the day, the reagent priority order determination flow may be shifted to the management based on the measurement value of the quality control substance in STEP 7 immediately after the start.

  Here, in the processes such as reagent registration, calibration, repetitive measurement, and quality control substance measurement, when the management range is exceeded, it may be possible to set it to be unusable without proceeding to the next process.

  FIG. 5 shows an example of actual determination according to the reagent priority order determination flow of FIG.

  When reagent containers A, B, and C for analyzing the same item by the automatic analyzer are mounted on the apparatus and a reagent registration operation is performed, the apparatus reads information on the identifier of the reagent container.

  Reagent containers A and B are opened the day before and are in use. The reagent container C is opened on the day and is the first time to be mounted on the apparatus.

  The automatic analyzer determines the reagent containers A and B based on the priority determination factor, and sets the priority order to 1 for the reagent container A and the priority order to 2 for the reagent container B.

  This may be inherited from the previous day as reagent container information. Since the reagent container C is not calibrated and the quality control substance is not measured, the priority order is not set.

  When reagent containers A, B, and C are subjected to calibration and quality control substance measurement, only reagent container A exceeds the numerical range set in the reagent management range, and reagent containers B and C are within the control range The automatic analyzer registers the setting “undispensable” for the reagent container A.

  In addition, in an automatic analyzer that manages the value of the calibrator strike-back measurement, a management range may be set for the strike-back value and used for determination of the reagent container.

  At the same time, the priority of use of the remaining reagent containers B and C for measuring the same item is advanced, and priority order 1 is set for the reagent container B and priority order 2 is set for the reagent container C.

  Even when the apparatus is made to determine the priority order of reagent use in this way, the priority order of dispensing from the reagent container can be changed by the operator changing the setting.

  In some cases, a verification test is performed when data is defective.

  In addition, when there is a reagent container that is determined as “unusable” by the apparatus, an alarm is issued to warn the operator, or to prompt the user to perform calibration or quality control substance measurement again.

  Reagent containers that have been set to “unusable” by the device can be used again by performing calibration and quality control substance measurement again successfully or by manually changing the setting to “usable”. .

  An example of the reagent management range setting screen in the second embodiment is shown in FIG.

  The reagent management range is set on the reagent management range setting screen displayed on the operation screen.

  The setting screen displays the analysis items of the automatic analyzer, and information such as the position of the reagent container, lot number, expiration date, remaining reagent amount, and number of days since opening the bottle is displayed for each reagent container. Link to the results screen and quality control screen.

  The display order of the reagent containers can be rearranged according to the priority of use.

  In addition, when a measurement item name is selected, a list of calibration results for a plurality of reagent containers that measure the item, a screen for overlaying reaction process curves, and selecting a reagent container, past calibration of the reagent container Displays a list of results or a screen for overwriting.

  With reference to these screens, the operator sets the priority order of the reagent containers or sets that the reagent containers cannot be used.

  For example, when four AST reagent containers are installed, the reagent containers are selected as “undispensable”, “1”, “2”, “3”, “4” by a pull-down button.

  Or you may set by inputting a number directly.

  However, in the same analysis unit, there may be a function for displaying guidance about a settable range so that priorities of a plurality of reagent containers measuring the same item do not overlap.

  There should be a comment entry field in the screen to add the reason for setting the order of use for the reagent containers.

  FIG. 7 shows an example of a screen that displays the calibration result and the repetitive measurement value.

  In particular, when performing calibrator repetitive measurement after performing non-linear calibration, if the repetitive measurement value deviates beyond the control range set in advance with respect to the displayed value, the device will use the reagent container. An alarm requesting the determination is issued, or the reagent container is automatically registered in the “undispensable” state.

  It is also possible to set a reagent container to be used preferentially in the case of retesting.

  A model of a system for sharing information about reagent containers is shown in FIG.

  Information accumulated about reagent containers such as the number of days since opening the reagent, priority, availability of use, calibration results, comments, etc. is shared between devices or modules via the host system that manages the automatic analyzer. The

  For example, in Example 1, when the reagent container D set in the reagent container in the state of “undispensable” when registered in the automatic analyzer 17b is additionally mounted on the automatic analyzer 17a, Based on the information from the container identifier, information on the reagent container is retrieved from the host system 18 and called.

  The reagent container D is registered in the automatic analyzer 17a as “undispensable”, and the reagent container D is also used for analysis in the automatic analyzer 17a unless the setting of “undispensable” is canceled in any apparatus. Not.

  If the measured value of the quality control substance for one reagent container shows an upward or downward trend, the device issues an alarm requesting a judgment on the use of the reagent container, or automatically applies to the reagent container. Decrease the priority of use or register the status as “Dispensable”.

  Further, there may be a function of displaying and managing the average value, maximum value, and minimum value of the measured value of the quality control substance for each measurement round.

  FIG. 9 shows an example in which the same quality control substance is analyzed three times per round for the same item.

  In the quality control setting, the number of measurements for analyzing the trend of the measured value of the quality control substance is registered as 5 tests, and the measurement of the quality control substance 3 times at a time is registered as the number of samples per round. .

  As an example of grasping the trend, on the measurement result screen of the quality control substance, as shown in FIG. 9, when a straight line by the least square method is created in the plot of the set number of measurement times, and the slope exceeds the set value, the device An alarm requesting a judgment about the use of the reagent container is issued, or the priority of use is automatically lowered for the reagent container, or the state of “undispensable” is registered.

  As a result, even within the management range, it is possible to prompt the operator to confirm the reagent status by grasping the tendency and issuing a warning.

  Moreover, in FIG. 10, the screen which displays the average value and the width | variety of a measured value is shown as an example about the measured value of the quality control substance for every measurement round.

  Display and manage the average value, maximum value, minimum value, and value range of the quality control substance measurement values for each round of measurement, and grasp the average measurement value of the quality control substance for each round for high reproducibility. It becomes easy to determine a change in the state of the reagent with time even if there is no item.

DESCRIPTION OF SYMBOLS 1 Sample cup 2 Sample disk 3 Sampling mechanism 4 Reagent dispensing mechanism 5 Reagent container 6 Reagent disk 7 Reader 8 Reaction cell 9 Reaction disk 10 Agitation mechanism 11 Washing mechanism 12 Photometer 13 Central processing unit 14 Operation part 15 Display part 16 Memory | storage Part 17 Automatic analyzer 18 Host system

Claims (6)

In an automatic analyzer equipped with a reagent container mounting mechanism capable of mounting multiple sets of reagent containers containing reagents for the same analysis item,
An automatic analysis comprising a change mechanism for changing the order in which the plurality of sets of reagent containers are used based on a measurement result of a quality control sample or a standard sample using the reagents contained in the reagent containers. apparatus. The automatic analyzer according to claim 1, wherein
The automatic analyzer is characterized in that the change mechanism performs a change including prohibiting the use of a reagent contained in a certain reagent container. The automatic analyzer according to claim 1,
The automatic analyzer is further characterized in that the change mechanism further allows an operator to change the order in which reagent containers are used. The automatic analyzer according to claim 1,
The measurement of the standard sample includes a measurement when the same standard sample is measured as a general specimen after the standard sample is measured for calibration. The automatic analyzer according to claim 1,
An automatic analyzer comprising a display mechanism for displaying a calibration result of a reagent stored in the plurality of sets of reagent containers or a reaction process curve when calibration is performed. The automatic analyzer according to claim 2,
An automatic analyzer having a function of sharing information that prohibits the use of the reagent between the whole inspection system, between modules, or between apparatuses.

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