JP2007322326A - Calibration term-of-validity management method, program for calibration term-of-validity management, and automatic analyzer - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a calibration term-of-validity management method, a program for calibration term-of-validity management, and an automatic analyzer, capable of preventing expiration of validity of calibration, and improving analysis accuracy and reliability. <P>SOLUTION: The term of validity of the calibration relative to a reagent held by the analyzer is read out, and existence of a calibration whose validity is expired within a prescribed time after reading is determined. When a calibration whose validity is expired within the prescribed time after reading exists as a result of determination, information including at least either of an analysis item corresponding to the pertinent calibration and a reagent lot is output. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention relates to a calibration expiration date management method, a calibration expiration date management program, and an automatic analyzer that manage the expiration date of calibration for a reagent used for analysis of a sample such as blood or body fluid.

  Conventionally, an automatic analyzer is known as a device for biochemically or immunologically analyzing a specimen such as blood or body fluid. In this automatic analyzer, before starting the analysis of a general sample, calibration for concentration calculation using a standard solution is performed on a reagent used for the analysis (see, for example, Patent Document 1).

  In an ordinary automatic analyzer, an expiration date for the calibration itself is provided separately from the expiration date for the reagent. When analyzing a general sample using a calibration result with an expiration date, the operator will execute a new calibration if the calibration expiration date has expired when the operator places an order to perform the analysis. The order (including the creation of a calibration curve) is performed first.

JP-A-9-325150

  In the prior art described above, in order for the operator to check the calibration expiration date, it is necessary to view a screen for displaying and outputting the calibration expiration date each time. For this reason, if the operator fails to confirm the calibration expiration date, the calibration result that has expired may be used for the analysis of general samples, which may reduce the accuracy and reliability of the analysis. .

  The present invention has been made in view of the above, and it is possible to prevent the expiration date of the calibration from occurring in advance, and to improve the accuracy and reliability of the analysis. It is an object of the present invention to provide a deadline management program and an automatic analyzer.

  In order to solve the above-described problems and achieve the object, the invention described in claim 1 includes a storage unit that stores information including a calibration expiration date for the reagent, and reacts the sample with the reagent to cause the sample to react. An automatic analyzer that analyzes the components of the calibration is a calibration expiration date management method for managing the expiration date of calibration, and reads out the expiration date of calibration for the reagent held by the automatic analyzer from the storage unit, A determination step for determining the presence or absence of a calibration that expires within a predetermined time after performing this reading, and a calibration that expires within a predetermined time after performing the reading as a result of the determination at the determination step. If present, the analysis item and test corresponding to the calibration in question And an output step of outputting information including at least one of the lot, and having a.

  According to a second aspect of the present invention, in the first aspect of the invention, the determination step and the output step are performed as a part of a series of processes when starting the automatic analyzer.

  The invention described in claim 3 is the invention described in claim 1, further comprising an analysis accepting step for accepting an order input for analysis execution of a general sample, wherein the determination step is performed after the analysis accepting step, and the output step Is performed when there is a calibration that expires within a predetermined time after performing the reading, and a new calibration execution order for the calibration that expires is not accepted. .

  According to a fourth aspect of the present invention, in the third aspect of the invention, following the calibration reception step of receiving a new calibration execution order input corresponding to the calibration that expires, and the calibration reception step And a general sample analysis step for performing the analysis of the general sample.

  According to a fifth aspect of the invention, in the third aspect of the invention, the analysis of the general sample is performed when there is no calibration execution order input within a predetermined time after outputting the information in the output step. It is characterized by.

  The predetermined time in the present invention is determined independently of the predetermined time in the first aspect of the invention.

  A calibration expiration date management program according to a sixth aspect of the invention causes the automatic analyzer to execute the calibration expiration date management method according to any one of the first to fifth aspects.

  The invention according to claim 7 is an automatic analyzer that analyzes the components of the sample by reacting the sample with the reagent, and stores information including the expiration date of calibration for the reagent held by the automatic analyzer A storage unit that reads the calibration expiration date of the reagent stored in the storage unit, a determination unit that determines whether there is a calibration that expires within a predetermined time after the readout, and a determination by the determination unit As a result, when there is a calibration that expires within a predetermined time after the reading, an output unit that outputs information including at least one of the analysis item and the reagent lot corresponding to the calibration And.

  According to the present invention, the expiration date of the calibration for the reagent held by the apparatus is read out, it is determined whether there is a calibration whose expiration date is expired within a predetermined time after the reading is performed, and as a result of the determination, the readout If there is a calibration that expires within a predetermined time after performing the calibration, the calibration is performed by outputting information including at least one of the analysis item and the reagent lot corresponding to the corresponding calibration. It is possible to provide a calibration expiration date management method, a calibration expiration date management program, and an automatic analyzer that can prevent the expiration date of the license from being expired and improve the accuracy and reliability of analysis. Become.

  Embodiments of the present invention will be described below with reference to the accompanying drawings. FIG. 1 is an explanatory diagram showing a functional configuration of a main part of an automatic analyzer according to an embodiment of the present invention. The automatic analyzer 1 shown in FIG. 1 dispenses a sample and a reagent into a reaction vessel, optically measures a reaction occurring in the reaction vessel, and controls and drives the measurement mechanism 101. A control analysis mechanism 102 that analyzes the measurement result in the mechanism 101 is provided, and these two mechanisms cooperate to automatically and continuously analyze the components of a plurality of specimens.

  The measuring mechanism 101 contains a plurality of racks 112 on which sample containers 111 for storing specimens such as blood and body fluid are mounted and sequentially transfers them, an emergency preparation in addition to a calibration curve preparation sample and a quality control sample. A sample table 12 that holds a sample container 121 that contains a specimen, a reaction table 13 that holds a reaction container 131 that reacts the sample and a reagent, and a reagent table 14 that holds a reagent container 141 are provided.

  The measurement mechanism 101 includes a stirring unit 15 that stirs the liquid stored in the reaction vessel 131, a photometric unit 16 that measures the intensity of each wavelength component of light passing through the reaction vessel 131, and the like. The cleaning unit 17 that cleans the reaction container 131 and the identification information (reagent ID) that is affixed to the outer surface of the reagent container 141 and includes the lot number of the reagent contained in the reagent container 141 and the expiration date of the reagent An information code reading unit 18 is provided for reading an information code such as a barcode.

  Further, the measurement mechanism 101 dispenses the sample accommodated in the sample container 111 on the sample transfer unit 11 or the sample accommodated in the sample container 121 on the sample table 12 into the reaction container 131. And a reagent dispensing unit 20 that dispenses the reagent accommodated in the reagent container 141 on the reagent table 14 into the reaction container 131.

  The sample table 12 transfers the sample container 121 to a sample suction position by the sample dispensing unit 19. The reaction table 13 also transfers the reaction container 131 to predetermined positions such as a sample dispensing position, a reagent dispensing position, a stirring position, a photometric position, and a washing position. Further, the reagent table 14 transfers the reagent container 141 to a reagent aspirating position by the reagent dispensing unit 20.

  The sample table 12, the reaction table 13, and the reagent table 14 are driven by a stepping motor under the control of the control unit 24 of the control analysis mechanism 102, and a vertical line passing through the center of each table is used as the rotation axis. Each can rotate freely. An openable / closable cover is provided above each table, and a thermostatic bath is provided below each table (not shown). Thereby, the container accommodated in the inside when the cover is closed can be kept at a constant temperature, and evaporation or denaturation of the sample or reagent in the container can be suppressed.

  The sample dispensing unit 19 and the reagent dispensing unit 20 pass through a tubular probe that performs aspiration and discharge of the sample and reagent respectively, ascending and descending in the vertical direction, and its base end to move the probe. An arm that freely rotates about a vertical line as a central axis, and an intake / exhaust mechanism using an intake / exhaust syringe or a piezoelectric element are provided. Each probe is cleaned by a cleaning unit (not shown) provided individually after one operation.

  Note that the measurement mechanism 101 serves as a dispensing unit other than the sample dispensing unit 19 and the reagent dispensing unit 20, for example, a diluent dispensing unit that holds and dispenses a diluent for diluting a sample or a reagent to an appropriate concentration. Part (not shown). The measurement mechanism 101 may further include a reagent table similar to the reagent table 14.

  Next, the configuration of the control analysis mechanism 102 will be described with reference to FIG. The control analysis mechanism 102 is realized by using one or a plurality of computers, and includes a keyboard, a mouse, a microphone, and the like for inputting various kinds of information (including an order for executing analysis and calibration) necessary for sample analysis. And an output unit 22 implemented by a display such as a CRT, a liquid crystal display, an organic EL display, a printer, a speaker, and the like for outputting and displaying analysis results and the like.

  The control analysis mechanism 102 also stores a storage unit 23 that stores the analysis result in the measurement mechanism 101, and a control unit 24 that controls each function or means in the control analysis mechanism 102 and controls the driving of the measurement mechanism 101. With.

  The storage unit 23 stores analysis items, reagent types, sample / reagent dispensing amounts, sample / reagent expiration dates, concentrations required to create a calibration curve, calibration expiration dates, reference values and tolerances for each analysis item. Stores and manages values, orders input from an operator (operator) and order for executing calibration, and analysis results.

  The storage unit 23 uses a hard disk that magnetically stores various information, and a memory that loads a program related to the process from the hard disk and electrically records the process when the automatic analyzer 1 executes the process. Realized. The storage unit 23 may further include an auxiliary storage device that can read information recorded on a recording medium such as a flexible disk, a CD-ROM, a DVD-ROM, an MO disk, a PC card, and an xD picture card. .

  The control unit 24 determines an analysis calculation unit 241 that performs an analysis calculation of the components of the sample based on the measurement result (absorbance of the reaction solution, etc.) in the measurement mechanism 101, and determines whether the calibration is valid or whether calibration is accepted. And a determination unit 242 that performs the determination. The control unit 24 is realized by a CPU (Central Processing Unit) or the like having control and calculation functions, and reads the program stored in the storage unit 23 from the memory to quantitatively determine the components of the reaction solution and the concentration thereof. Control and calculation of various operations of the automatic analyzer 1 including calculation are executed.

  FIG. 2 is a flowchart showing an outline of the calibration expiration date management method according to the embodiment of the present invention. FIG. 2 shows an outline of a calibration expiration date management method performed as part of a series of processes at the time of starting the automatic analyzer 1 having the above-described configuration.

  When the power supply is turned on and the automatic analyzer 1 is activated (step S1), the control unit 24 reads out and acquires the index of the analysis item from the storage unit 23, and the reagent container 141 held in the reagent table 14 stores the reagent. The information code reading unit 18 reads the barcode for recording the identification information (reagent ID), and writes the read information in the storage unit 23 for storage (steps S2 and S3). Since these two steps S2 and S3 are performed independently and in parallel, they are not necessarily performed in the order shown in FIG.

  Note that the information regarding the analysis items and reagents acquired in steps S2 and S3 (including the position information of the reagent container 141 in addition to the reagent ID) may be output from the output unit 22. As a result, the operator can check the analysis items that can be executed by the automatic analyzer 1 and the installation status of the reagent container 141 in the reagent table 14 when the automatic analyzer 1 is activated.

  Next, the calibration expiration date is checked (step S4). More specifically, the determination unit 242 reads out information including the expiration date of the calibration specified by the analysis item and the lot of the reagent used in each analysis item from the storage unit 23, so that the predetermined time from the time of reading is determined. Determine whether there is a calibration that expires within the time. Note that the operator may set a predetermined time as a reference for this determination in advance. Alternatively, an analysis item and / or reagent lot for which the operator wants to check the calibration expiration date may be selected in advance, and the determination unit 242 may check the calibration expiration date based on the selection.

  As a result of the determination in step S4, if there is a calibration that expires within a predetermined time (Yes in step S5), the output unit 22 provides information related to the calibration (analysis item, reagent lot, calibration of the calibration). (Expiration date, etc.) is output (step S6). Here, the output unit 22 may display the information on the screen, or may output the information by sound from a speaker.

  On the other hand, when there is no calibration that expires in step S5 (No in step S5), a series of processing at the time of starting the automatic analyzer 1 is ended as it is.

  As described above, the calibration expiration date is checked when the automatic analyzer 1 is started, and if there is a calibration whose expiration date expires within a predetermined time from that time, information on the calibration is output and the operator is output. Thus, even if the operator forgets to check the remaining time of the calibration expiration date, calibration including creation of a calibration curve or order input for execution can be performed at an appropriate time.

  FIG. 3 is a flowchart showing an outline of the calibration expiration date management method performed by the automatic analyzer 1 in accordance with the analysis of the general sample. In the case shown in the figure, first, the input unit 21 receives an order input for execution of analysis on a general sample (step S11).

  Thereafter, the determination unit 242 checks the calibration expiration date (step S12). More specifically, the determination unit 242 reads out information including the expiration date of the calibration specified by the analysis item received in step S11 and the lot of the reagent used in each analysis item from the storage unit 23. The presence / absence of calibration that expires within a predetermined time from the time of reading is determined.

  As a result of this determination, there is a calibration that expires within a predetermined time (Yes in step S13), and a new calibration execution order corresponding to the calibration has already been received (Yes in step S14). In step S15, the general sample is analyzed. The order of execution of calibration in step S14 here includes an analysis item to be calibrated, a reagent used for calibration, identification information of the reagent, and the like. If there is no calibration that expires within a predetermined time (No in step S13), the process proceeds to step S15 as it is to analyze a general sample.

  On the other hand, when a new calibration execution order has not been received for a calibration that expires within a predetermined time (No in step S14), the output unit 22 provides information on the calibration (analysis item, reagent lot, and calibration thereof). The operator is notified (step S16).

  If the predetermined time has passed without any input after step S16 (Yes in step S17), the process proceeds to step S15 to analyze the general sample. On the other hand, if the predetermined time has not yet elapsed (No in step S17), the process proceeds to step S15 at the time when the operator inputs an order for calibration execution (Yes in step S18), while the calibration execution is performed. If there is no order input (No in step S18), the process returns to step S17 and waits until a predetermined time elapses. The predetermined time in step S17 is determined independently of the predetermined time in step S13.

  Here, after the notification to the operator in step S16, the analysis of the general sample is started even if the predetermined time has passed without any input, while a new calibration is performed during the analysis operation accepted in step S11. This is because it may not be necessary to execute the operation. In this sense, when outputting information related to the calibration in step S16, a content may be displayed that prompts the operator to select whether or not to immediately execute the calibration execution order. In this case, it is determined whether to immediately shift to the analysis of the general sample or to perform the analysis of the general sample after receiving the calibration execution order according to the selection of the operator input thereafter.

  As described above, by checking the calibration expiration date when the automatic analyzer 1 starts the analysis, the operator forgets to confirm the remaining time of the calibration expiration date as when the automatic analyzer 1 is started. Even if there is an analysis item or reagent lot whose calibration expires within a predetermined time, the automatic analyzer 1 automatically confirms it and notified the operator to that effect. The operator can perform calibration or order entry for execution at an appropriate time.

  In this case, even if the calibration expiration date is expired during the analysis of a general sample, it is possible to cope with it accurately, so the accuracy and reliability of the analysis can be further improved. It becomes.

  Also in the case of the calibration expiration date management method shown in FIG. 3, the operator may set the predetermined time in steps S12 and S17 in advance.

  According to the embodiment of the present invention described above, the expiration date of the calibration for the reagent held by the apparatus is read, and it is determined whether or not there is a calibration that expires within a predetermined time after the reading. As a result of the determination, if there is a calibration that expires within a predetermined time after the reading, information including at least one of the analysis item and the reagent lot corresponding to the calibration By outputting, it is possible to prevent the expiration date of the calibration from occurring and improve the accuracy and reliability of the analysis.

  As mentioned above, although one form considered to be the best in practicing the present invention has been described in detail, the present invention is not limited only to this one embodiment. That is, the present invention can include various embodiments and the like not described herein, and various design changes and the like can be made without departing from the technical idea specified by the claims. Is possible.

It is explanatory drawing which shows the function structure of the automatic analyzer principal part which concerns on one embodiment of this invention. It is a flowchart which shows the outline | summary (at the time of apparatus starting) of the calibration expiration date management method which concerns on one embodiment of this invention. It is a flowchart which shows the outline | summary (at the time of an analysis operation start) of the calibration expiration date management method which concerns on one embodiment of this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Automatic analyzer 11 Sample transfer part 12 Sample table 13 Reaction table 14 Reagent table 15 Stirring part 16 Photometry part 17 Washing part 18 Information code reading part 19 Sample dispensing part 20 Reagent dispensing part 21 Input part 22 Output part 23 Storage part 24 Control Unit 101 Measurement Mechanism 102 Control Analysis Mechanism 111 Sample Container 112 Rack 121 Sample Container 131 Reaction Container 141 Reagent Container 241 Analysis Operation Unit 242 Determination Unit

Claims (7)

A calibration unit with a storage unit that stores information including the calibration expiration date for the reagent, and an automatic analyzer that analyzes the components of the sample by reacting the sample with the reagent manages the calibration expiration date. A deadline management method,
A determination step of reading out the expiration date of calibration for the reagent held by the automatic analyzer from the storage unit, and determining the presence or absence of calibration that expires within a predetermined time after performing this reading;
As a result of the determination in the determination step, when there is a calibration that expires within a predetermined time after the reading, information including at least one of an analysis item and a reagent lot corresponding to the calibration An output step for outputting
A calibration expiration date management method characterized by comprising:   The calibration expiration date management method according to claim 1, wherein the determination step and the output step are performed as part of a series of processes when starting the automatic analyzer. An analysis receiving step for receiving an order input for performing an analysis of a general sample;
The determination step is performed after the analysis reception step,
The output step is performed when there is a calibration that expires within a predetermined time after the reading, and a new calibration execution order is not accepted for the calibration that expires. The calibration expiration date management method according to claim 1, wherein: A calibration accepting step for accepting a new calibration execution order input corresponding to the calibration that expires;
A general sample analysis step for performing analysis of the general sample following the calibration reception step;
The calibration expiration date management method according to claim 3, further comprising:   4. The calibration expiration date management method according to claim 3, wherein the general sample is analyzed when there is no calibration execution order input within a predetermined time after information is output in the output step.   A calibration expiration date management program for causing the automatic analyzer to execute the calibration expiration date management method according to claim 1. An automatic analyzer that analyzes components of a sample by reacting the sample with a reagent,
Storage means for storing information including the expiration date of calibration for the reagent held by the automatic analyzer;
A determination means for reading the calibration expiration date of the reagent stored in the storage means, and determining the presence or absence of calibration that expires within a predetermined time after performing this reading;
As a result of the determination by the determination means, when there is a calibration that expires within a predetermined time after the reading, information including at least one of an analysis item and a reagent lot corresponding to the corresponding calibration Output means for outputting,
An automatic analyzer characterized by comprising:

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