JP2007315785A - Autoanalyzer, analysis continuation possibility determining method for the autoanalyzer, and analysis continuation possibility determining program for the autoanalyzer - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an autoanalyzer which realizes speeding up of inspection and reduces waste in a specimen or a reagent that can suppress increase in the inspection cost, and to provide an analysis continuation possibility determining method for the autoanalyzer, and an analysis continuation possibility program for the autoanalyzer. <P>SOLUTION: When analysis continuation data for prescribing whether analysis is continued, with respect to one or a plurality of matters predetermined as the matters of a detection target is stored and the occurrence of the matters of the detection target is detected, the possibility determination for analysis continuation, corresponding to the matter of the detection target is performed, in reference to the analysis continuation possibility data, and the continuation or interruption of analysis is controlled, on the basis of this determination result. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention relates to an automatic analyzer that analyzes a sample by reacting the sample with a reagent, and an analysis of the automatic analyzer that determines whether or not to continue the analysis according to an event that occurs during the analysis. The present invention relates to a determination method and a program for determining whether or not to continue analysis of an automatic analyzer.

  Conventionally, in an automatic analyzer that analyzes a sample by reacting the sample with a reagent, for example, when an event such as a presumed abnormality occurs, such as when the reagent runs out during analysis, There is known a technique in which an operator sets whether the analysis operation after the occurrence of an event is interrupted uniformly or continued regardless of the type of specimen and the examination item.

  In contrast, when an event such as that described above occurs in an analysis system equipped with a plurality of automatic analyzers, the technology that disconnects the automatic analyzer that generated the event from the analysis system and continues the analysis of other automatic analyzers Is also disclosed (for example, see Patent Document 1).

JP 2004-28931 A

  However, for example, if the setting is made so that the analysis is uniformly interrupted when the reagent related to one analysis item runs out, the analysis related to the other analysis items is interrupted, so the speed of the test is impaired. There was a fear.

  In addition, when an automatic analyzer that has run out of reagents in the analysis system is disconnected from the analysis system, the disconnected automatic analyzer interrupts the analysis related to other analysis items. There was a risk that speediness might be impaired.

  On the other hand, for example, if the setting is made to continue the analysis when nozzle clogging occurs, reanalysis may be necessary depending on the type of specimen, resulting in the There is a problem in that waste occurs and inspection costs increase.

  The present invention has been made in view of the above, and it is possible to realize an automatic analyzer and an automatic analyzer that can speed up testing and reduce the waste of specimens and reagents and suppress increase in testing cost. It is an object of the present invention to provide a method for determining whether or not to continue analysis and a program for determining whether or not to continue analysis of an automatic analyzer.

  In order to solve the above-described problems and achieve the object, the invention according to claim 1 is an automatic analyzer that analyzes a sample by reacting the sample with a reagent, and the event to be detected is detected in advance. Storage means for storing analysis continuation permission / prohibition information that defines whether or not to continue the analysis for each one or more predetermined events, detection means for detecting the occurrence of the event to be detected, and generated by the detection means Whether to continue the analysis according to the detected event is determined by referring to the analysis continuation information stored in the storage unit, and the continuation or interruption of the analysis is controlled based on the determination result of the determination unit And a control means.

  According to a second aspect of the present invention, in the first aspect of the present invention, the information processing apparatus further includes an identification unit that identifies a type and / or analysis item of the sample being analyzed, and the determination unit includes the event detected by the detection unit and the event It is characterized in that it is determined whether or not the analysis can be continued in accordance with the type of the sample under analysis identified by the identification means and / or the combination with the analysis item.

  The invention described in claim 3 is characterized in that, in the invention described in claim 1 or 2, the analysis continuation permission information can be changed.

  According to a fourth aspect of the present invention, an automatic analyzer that analyzes the specimen by reacting the specimen with a reagent automatically determines whether to continue the analysis when an event to be detected occurs. An analysis apparatus determination method for determining whether or not to continue analysis, comprising: a storage unit that stores analysis continuation permission / rejection information that defines whether or not to continue the analysis for each of one or a plurality of events predetermined as the detection target event The automatic analysis apparatus detects from the storage unit whether or not to continue the analysis according to the detection step for detecting the occurrence of the event to be detected and whether to continue the analysis according to the event for which the occurrence was detected in the detection step. A determination step performed by referring to the information, and a control step for controlling the continuation or interruption of the analysis based on the determination result of the determination step. And butterflies.

  According to a fifth aspect of the present invention, in the fourth aspect of the invention, the method further comprises an identification step for identifying the type of the sample under analysis and / or the analysis item, and the determination step includes the event detected in the detection step. Whether to continue the analysis is determined according to the type of the sample being analyzed and / or the combination with the analysis item identified in the identification step.

  The invention according to claim 6 is the invention according to claim 4 or 5, characterized in that the analysis continuation permission information can be changed.

  The analysis program for determining whether or not to continue analysis of the automatic analyzer according to the invention described in claim 7 causes the automatic analyzer to execute the analysis continuity determination method of the automatic analyzer according to any one of claims 4 to 6. It is characterized by.

  According to the present invention, analysis continuation permission / prohibition information that defines whether or not to continue the analysis for each one or a plurality of events that are predetermined as detection target events is stored, and the occurrence of the detection target event is detected. In this case, whether to continue the analysis according to the event is determined with reference to the analysis continuation permission information, and the continuation or interruption of the analysis is controlled based on the determination result, thereby speeding up the inspection. At the same time, it is possible to reduce the waste of specimens and reagents and to suppress an increase in test costs.

  The best mode for carrying out the present invention (hereinafter referred to as “embodiment”) will be described below with reference to the accompanying drawings. FIG. 1 is a 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 (sample) and a reagent into a reaction container, optically measures a reaction occurring in the reaction container, and performs drive control of the measurement mechanism 101. In addition, a control analysis mechanism 102 that analyzes the measurement results in the measurement mechanism 101 is provided, and these two mechanisms cooperate to automatically and continuously analyze the components of a plurality of specimens.

  The measurement mechanism 101 of the automatic analyzer 1 includes a sample transfer unit 11 that stores and sequentially transfers a plurality of racks 112 on which a plurality of sample containers 111 that respectively store general samples such as blood and body fluids are stored, and other than general samples. A sample table 12 that holds a plurality of sample containers 121 each containing various samples, a reaction table 13 that holds a reaction container 131 that dispenses and reacts the sample and a reagent, and a reagent table 14 that holds a reagent container 141 And comprising.

  The measuring mechanism 101 includes a stirring unit 15 that stirs the liquid contained in the reaction vessel 131 and a photometric unit that measures the intensity of light passing through the reaction vessel 131 using a photodiode or a photomultiplier tube. 16, a cleaning unit 17 that cleans the reaction container 131 after the measurement, a general sample stored in the sample container 111 on the sample transfer unit 11, and various samples stored in the sample container 121 on the sample table 12. And a reagent dispensing unit 19 for dispensing the reagent contained in the reagent container 141 on the reagent table 14 to the reaction container 131.

  A stepping motor is attached to each of the sample table 12, the reaction table 13, and the reagent table 14, and each of the sample table 12, the reaction table 13, and the reagent table 14 is rotatable about a vertical line passing through the center of each table. In addition, an openable / closable cover is provided above each table, and a thermostatic bath is provided below each table (not shown). Thereby, the container hold | maintained at each table can be kept at a constant temperature state, and evaporation and denaturation of the sample or reagent accommodated in the container can be suppressed.

  The sample dispensing unit 18 and the reagent dispensing unit 19 pass through a narrow tubular nozzle that performs suction and discharge of the sample and the reagent, and the vertical movement and the base end of the nozzle for moving the nozzle. 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.

  Next, the configuration of the control analysis mechanism 102 of the automatic analyzer 1 will be described. The control analysis mechanism 102 is based on an input unit 21 that receives input of various information necessary for sample analysis from the outside of the apparatus, an output unit 22 that outputs various information including analysis results, and a measurement result in the measurement mechanism 101. An analysis unit 23 that analyzes the sample, a detection unit 24 that detects the occurrence of a predetermined event that occurs during the analysis, an identification unit 25 that identifies the type of sample being analyzed, and at least various types of analysis A storage unit 26 that stores various information, a determination unit 27 that determines whether analysis can be continued according to the identification result in the identification unit 25 when a predetermined event occurs, and each function or each in the control analysis mechanism 102 And a control unit 28 that controls the means and controls the driving of the measurement mechanism 101.

  When the analysis unit 23 receives the measurement result related to the analysis from the photometry unit 16 of the measurement mechanism 101, the analysis unit 23 reads information related to the analysis of the sample that is the measurement target from the storage unit 26, and performs an analysis operation on the measurement result. In this analytical calculation, the absorbance of the reaction solution is calculated based on the measurement result sent from the photometry unit 16, and in addition to this calculation result, the analytical parameters included in the calibration curve and analysis information are used. Quantitatively determine ingredients. The analysis result obtained in this way is output from the output unit 22 and stored and stored in the storage unit 26.

  Events to be detected by the detection unit 24 include a lack of reagent, data failure, clogged nozzles in the sample dispensing unit 18 and the reagent dispensing unit 19, a shortage of calibration curve creation points, and a photometric range check. There are errors. Which event is to be detected from among the events that are supposed to occur at the time of analysis can be set in advance by input from the input unit 21.

  The types of samples being analyzed by the identification unit 25 include general samples, standard samples for preparing calibration curves, quality control samples, emergency samples, STAT samples, and retest samples.

  The storage unit 26 stores analysis continuation permission / prohibition information that defines, for each detection target event, whether or not to continue the analysis when the detection target event occurs. The storage unit 26 also stores analysis items, reagent types, sample / reagent dispensing amounts, sample / reagent expiration dates, concentrations required for the creation of calibration curves, calibration curve expiration dates, and reference values for each analysis item. And parameters necessary for analysis such as the allowable value and the analysis result in the analysis unit 23 are stored and managed.

  The storage unit 26 is implemented using a hard disk that magnetically stores 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. . As such a program, an analysis continuity determination program for causing the automatic analyzer 1 to execute an analysis continuation determination method described later is also included. The storage unit 26 may 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 analysis continuation determination program can be recorded on such a recording medium and widely distributed.

  The determination unit 27 reads out from the storage unit 26 information on whether or not to continue the analysis according to the combination of the event detected by the detection unit 24 and the type of the sample being analyzed identified by the identification unit 25, thereby performing subsequent analysis. It is determined whether or not to continue.

  The control unit 28 is realized by a CPU (Central Processing Unit) or the like having control and calculation functions, and reads out a program stored in the storage unit 26 from the storage unit 26 so as to control and calculate various operations of the automatic analyzer 1. Execute.

  In the control analysis mechanism 102, the detection unit 24, the identification unit 25, the storage unit 26, the determination unit 27, and the control unit 28 sequentially include at least a part of the detection unit, identification unit, storage unit, determination unit, and control unit. Needless to say, each function is realized.

  In the automatic analyzer 1 having the above configuration, the operator selects an event to be detected from events expected to occur during the analysis, and selects the detected event to be detected and the sample being analyzed. According to the combination with the type of information, analysis continuation permission / prohibition information that prescribes whether or not the analysis can be continued after the occurrence of an event is preset. The analysis continuation permission / inhibition information is set by inputting a predetermined signal from the input unit 21. At this time, a setting screen is displayed on the display provided in the output unit 22 to selectively input the operator. You may make it prompt. Note that the input unit 21 may include a microphone in addition to the keyboard and mouse, and the operator sets the analysis continuation permission information by manual input using the keyboard or mouse or voice input using the microphone.

  FIG. 2 is a diagram illustrating a configuration example of the analysis continuation permission / inhibition information. In the analysis continuation permission / inhibition information table 201 shown in the figure, it is defined whether the analysis after the occurrence of the event is continued (O) or interrupted (X) according to the combination of the event and the sample type. Hereinafter, setting examples recorded in the analysis continuation permission / inhibition information table 201 will be described.

  First, an example of setting when the reagent runs out in any of the reagents A to C will be described. The analysis continuation permission / inhibition information table 201 is set so that when the reagent runs out during the analysis of the general sample, the analysis is continued only in the event that the reagent C runs out (no reagent C). This corresponds to a setting example in which, for example, the number of requests is significantly smaller in the analysis using the reagent C than in the analysis using the reagent A and the reagent B. In such a case, the number of requests for the analysis using the reagent A and the reagent B is large. Therefore, if these reagents run out, it is faster to stop the analysis and add a new reagent. On the other hand, if the reagent C runs out, it is effective to continue the analysis in order to suppress a decrease in throughput, so the setting as described above is made.

  If the reagent runs out during the analysis of the urgent sample, the analysis is continued regardless of the type of the reagent that caused the reagent running out in view of the priority given to rapidity.

  If the reagent runs out during the analysis of the standard sample, the analysis is set to be interrupted. This is because it is necessary to perform additional replenishment of the reagent after the reagent has run out, and the analysis using the standard sample is meaningless unless it is performed after replacing the reagent. Thereby, it is possible to prevent the standard sample from being wasted.

  If the reagent runs out during the analysis of the quality control sample, the process is continued only when the reagent B runs out. This is a setting example in the case where, for example, the deadline that requires new accuracy management for the reagent B (analysis item using the reagent B) is still far ahead and it is not necessary to perform the accuracy management using the reagent B for the time being. It corresponds.

  Next, a case where a data abnormality occurs will be described. In this case as well, for the standard sample, the analysis is interrupted for the same reason as described above, and the operation is stopped. As a result, even if an item that cannot be analyzed using the standard sample occurs, the analysis can be immediately interrupted to eliminate the clogging of the nozzle, and the waste of the standard sample or reagent can be reduced. If a data abnormality occurs during the analysis of the quality control sample, troubles such as a failure of the automatic analyzer 1 itself are expected, so the analysis is interrupted for inspection. Thereby, it is possible to prevent waste of the sample and the reagent.

  If a data abnormality occurs during analysis of a general sample or an emergency sample, at least the analysis operation is continued for those already on the reaction table 13. This is because it is more preferable to continue, because it is possible to prevent a decrease in throughput.

  Next, a case where the nozzle of the sample dispensing unit 18 is clogged (sample dispensing nozzle clogged) will be described. In this case, the analysis is continued for the general sample and the emergency sample, and the analysis is suspended for the standard sample and the quality control sample, as in the case where the data abnormality occurs.

  Note that the analysis continuation permission / inhibition information described above is merely a setting example. That is, the setting of the detection target event and the setting of whether to continue according to the combination of the event and the type of the sample can be changed as appropriate according to various circumstances such as the operation status of the automatic analyzer 1 and the increase / decrease of the reagent. Is possible.

  FIG. 3 is a flowchart showing an outline of processing of the method for determining whether or not analysis can be continued in the automatic analyzer according to the embodiment of the present invention. After setting the analysis continuation permission information as described above and storing it in the storage unit 26, the automatic analyzer 1 starts analyzing the sample (step S1). If the detection unit 24 detects the occurrence of any of the detection target events during the analysis (Yes in step S2), the identification unit 25 identifies the type of sample being analyzed (step S3). Note that the identification unit 25 may always identify the type of reagent under analysis regardless of whether an event has occurred.

  Thereafter, the determination unit 27 reads out and refers to the analysis continuation permission / inhibition information corresponding to the combination of the detection result in the detection unit 24 and the identification result in the identification unit 25 from the storage unit 26 and continues or interrupts the analysis. (Analysis continuation determination) is performed (step S4).

  If the analysis is interrupted as a result of the determination in step S4 (Yes in step S5), the operation of the automatic analyzer 1 is temporarily stopped and the analysis is interrupted (step S6). After that, the analysis is resumed when processing necessary for restoration (for example, replacement of the reagent container 141 that has run out of reagents, elimination of clogging of the dispensing nozzle, etc.) is completed (step S7). Return. On the other hand, when the analysis is continued (No in step S5), the process directly returns to step S2.

  If no detection target event is detected in step S2 (No in step S2), if there is still a sample to be analyzed (Yes in step S8), the process returns to step S2. On the other hand, if there is no sample to be analyzed (No in step S8), the analysis operation is terminated (step S9).

  According to the embodiment of the present invention described above, analysis continuation permission / prohibition information that defines whether or not to continue the analysis for each one or a plurality of events predetermined as detection target events is stored, When the occurrence of an event to be detected is detected, whether to continue the analysis according to the event is determined by referring to the analysis continuation permission information, and the continuation or interruption of the analysis is controlled based on the determination result As a result, it is possible to speed up the test and reduce the waste of the sample and the reagent, thereby suppressing an increase in the test cost.

  Further, according to the present embodiment, by setting the analysis continuation permission / inhibition information in advance, the analysis continuation permission / inhibition determination is automatically performed when the detection target event occurs, and the automatic analysis device is based on the determination result. Since the operation state is autonomously changed, it is not necessary for the operator to determine whether to continue the analysis each time. Therefore, it is possible to greatly reduce the burden on the operator, and it is possible to determine whether to continue the analysis more quickly and accurately.

  The best mode for carrying out the present invention has been described in detail so far, but the present invention should not be limited by the above-described embodiment. For example, instead of constructing analysis continuation information depending on the combination of the detection target event and the type of sample being analyzed, the analysis is performed by combining the type of sample being analyzed and / or the test item with the event to be detected. The continuation permission / inhibition information may be configured. In this case, the identification unit may identify according to the constituent elements of the analysis continuation permission information, more specifically, the type and / or examination item of the sample being analyzed.

  In addition, since the automatic analyzer according to the present invention generally performs the analysis related to a plurality of analysis items at the same time, two different events set as analysis continuation permission / inhibition information may occur at the same time. In this case, if the analysis continuation determination results for each of the multiple events include both continuation and interruption determinations, the interruption determination is given priority over the continuation determination, and the analysis operation is suspended. Should be done.

  Note that the measurement mechanism of the automatic analyzer according to the present invention is not limited to the one having the configuration shown in FIG. 1, and various types of conventionally known measurement mechanisms of automatic analyzers are applied. Is possible.

  Thus, 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. It is possible to apply.

It is a figure which shows the function structure of the automatic analyzer principal part which concerns on one embodiment of this invention. It is a figure which shows the structural example of the analysis continuation permission information. It is a flowchart which shows the outline | summary of a process of the analysis analysis availability determination method of the automatic analyzer which concerns on one embodiment of this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Automatic analyzer 11 Specimen transfer part 12 Specimen table 13 Reaction table 14 Reagent table 15 Stirrer 16 Photometry part 17 Washing part 18 Sample dispensing part 19 Reagent dispensing part 21 Input part 22 Output part 23 Analytical part 24 Detection part 25 Identification Unit 26 storage unit 27 determination unit 28 control unit 101 measurement mechanism 102 control analysis mechanism 111, 121 sample container 112 rack 131 reaction container 141 reagent container 201 analysis continuation allowance information table

Claims (7)

An automatic analyzer that analyzes the sample by reacting the sample with a reagent,
Storage means for storing analysis continuation permission / prohibition information that defines whether or not to continue the analysis for each of one or a plurality of events predetermined as detection target events;
Detecting means for detecting the occurrence of the event to be detected;
Determination means for determining whether to continue analysis according to an event whose occurrence is detected by the detection means, by referring to analysis continuation permission information stored in the storage means;
Control means for controlling continuation or interruption of the analysis based on the determination result of the determination means;
An automatic analyzer characterized by comprising: An identification means for identifying the type of sample being analyzed and / or the analysis item;
The determination unit determines whether or not to continue the analysis according to a combination of the event detected by the detection unit and the type and / or analysis item of the sample being analyzed identified by the identification unit. The automatic analyzer according to 1.   3. The automatic analyzer according to claim 1, wherein the analysis continuation permission information can be changed. Method for determining whether or not to continue analysis in an automatic analyzer that determines whether or not to continue analysis when an event to be detected occurs using an automatic analyzer that analyzes the sample by reacting the sample and a reagent Because
The automatic analyzer including a storage unit that stores analysis continuation propriety information that specifies whether or not to continue the analysis for each one or a plurality of events predetermined as the detection target event,
A detection step of detecting the occurrence of the event to be detected;
A determination step for determining whether or not to continue analysis according to the event whose occurrence is detected in the detection step, by referring to the analysis continuation permission / inhibition information read from the storage unit;
A control step for controlling the continuation or interruption of the analysis based on the determination result of the determination step;
The method for determining whether or not to continue the analysis by the automatic analyzer, characterized in that: And further comprising an identification step for identifying the type of sample and / or analysis item being analyzed,
The determination step determines whether or not to continue the analysis according to a combination of the event detected in the detection step and the type and / or analysis item of the sample being analyzed identified in the identification step. 4. The method for determining whether or not to continue analysis by the automatic analyzer according to 4.   6. The method according to claim 4, wherein the analysis continuation permission / inhibition information can be changed.   A program for determining whether or not to continue analysis of an automatic analyzer, which causes the automatic analyzer to execute the method for determining whether or not to continue analysis of an automatic analyzer according to any one of claims 4 to 6.

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