WO2006009251A1 - 分析支援方法、分析装置、遠隔コンピュータ、データ解析方法及びプログラム並びに試薬容器 - Google Patents
分析支援方法、分析装置、遠隔コンピュータ、データ解析方法及びプログラム並びに試薬容器 Download PDFInfo
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- WO2006009251A1 WO2006009251A1 PCT/JP2005/013487 JP2005013487W WO2006009251A1 WO 2006009251 A1 WO2006009251 A1 WO 2006009251A1 JP 2005013487 W JP2005013487 W JP 2005013487W WO 2006009251 A1 WO2006009251 A1 WO 2006009251A1
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- reagent
- analysis
- data
- analyzer
- result
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Classifications
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N35/00594—Quality control, including calibration or testing of components of the analyser
- G01N35/00613—Quality control
- G01N35/00663—Quality control of consumables
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N35/00722—Communications; Identification
- G01N35/00732—Identification of carriers, materials or components in automatic analysers
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N35/00722—Communications; Identification
- G01N35/00871—Communications between instruments or with remote terminals
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
- G16H10/40—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
- B01L3/54—Labware with identification means
- B01L3/545—Labware with identification means for laboratory containers
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N35/00594—Quality control, including calibration or testing of components of the analyser
- G01N35/00613—Quality control
- G01N35/00663—Quality control of consumables
- G01N2035/00673—Quality control of consumables of reagents
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N35/00722—Communications; Identification
- G01N35/00732—Identification of carriers, materials or components in automatic analysers
- G01N2035/00742—Type of codes
- G01N2035/00782—Type of codes reprogrammmable code
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N35/00722—Communications; Identification
- G01N35/00732—Identification of carriers, materials or components in automatic analysers
- G01N2035/00792—Type of components bearing the codes, other than sample carriers
- G01N2035/00811—Type of components bearing the codes, other than sample carriers consumable or exchangeable components other than sample carriers, e.g. detectors, flow cells
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N35/00722—Communications; Identification
- G01N35/00732—Identification of carriers, materials or components in automatic analysers
- G01N2035/00821—Identification of carriers, materials or components in automatic analysers nature of coded information
- G01N2035/00841—Identification of carriers, materials or components in automatic analysers nature of coded information results of the analyses
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N35/00722—Communications; Identification
- G01N35/00732—Identification of carriers, materials or components in automatic analysers
- G01N2035/00821—Identification of carriers, materials or components in automatic analysers nature of coded information
- G01N2035/00851—Identification of carriers, materials or components in automatic analysers nature of coded information process control parameters
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T436/00—Chemistry: analytical and immunological testing
- Y10T436/11—Automated chemical analysis
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T436/00—Chemistry: analytical and immunological testing
- Y10T436/11—Automated chemical analysis
- Y10T436/115831—Condition or time responsive
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T436/00—Chemistry: analytical and immunological testing
- Y10T436/12—Condition responsive control
Definitions
- the present invention relates to a support technology for analysis using a reagent.
- the control unit controls various information such as reagent information, measurement conditions, and calibration curve data item definition information as operating conditions of the analyzer.
- the information storage means is divided into a plurality of hard disk drives or a plurality of partitions and backed up under predetermined conditions. It also provides remote maintenance by managing information in markup languages. Although it is possible to manage the reagent in the analyzer, it is considered that the reagent is managed by keeping useful information in the reagent itself.
- JP 2004-28670 A describes a service company acting on behalf of an analysis preparation work performed by an inspection facility via communication means, thereby reducing the burden on the inspector of the inspection facility and preparing for the analysis.
- a technique for stabilizing work or the like is disclosed.
- the inspection facility that performs analysis work using automatic analyzers, etc., and the data such as the operation status of automatic analyzers are obtained in real time via communication lines, and various data analysis such as diagnosis and maintenance inspections are performed.
- a service company that conducts service operations and a plurality of inspectors who conduct analysis work at the inspection facility have means that can be communicated at any time via communication means.
- Patent Document 2 JP 2004-28670 A
- an object of the present invention is to provide a novel reagent management technique in a case where data relating to the reagent in the container is held in the reagent container itself.
- Another object of the present invention is to provide a novel analysis support technique when a reagent is connected to a network.
- the analysis support method includes an analyzer using a reagent container having a memory for storing reagent information relating to the reagent inside the container, and a remote computer to which the analyzer is connected.
- a host computer having a step of reading reagent information from the reagent container memory, and using the reagent in the reagent container based on the read reagent information
- a determination step for determining whether or not the reagent in the reagent container is unusable a step for writing data indicating the unusability in the memory of the reagent container, and that the reagent in the reagent container is unusable. If determined, data indicating that the reagent container cannot be used corresponding to the identification information for identifying the reagent container is registered in the reagent database managed by the remote computer. Including the steps to record.
- reagents that should not be used are automatically identified and not used for analysis.
- reagent management and setting can be performed.
- automatic ordering of reagents can be used to improve operational efficiency, such as inventory management.
- the usage specified based on the usage result of the reagent having a predetermined relationship with the reagent in the reagent container is used.
- Data indicating that the reagent cannot be used when it is determined that the reagent in the reagent container cannot be used in the second determining step for determining whether or not the reagent in the reagent container can be used on the basis of the availability condition. May be included in the memory of the reagent container.
- the use-ability conditions of the reagent having a predetermined relationship with the reagent in the reagent container are also specified (for example, a reagent contained in a specific lot that has been found to cause a problem in actual analysis) Based on the (Condition)), whether or not the reagent in the reagent container can be used is satisfied, for example, the storage condition is satisfied! This makes it possible to manage reagents using specific conditions that can be determined by actual use.
- the method may further include a step of determining whether there is an abnormality in the analyzer based on the analyzer information related to the operating status of the analyzer. It can be managed even with an analyzer that uses only reagents.
- the step of writing the data related to the result of the analysis into the memory of the reagent container and the data related to the result of the analysis are managed by the remote computer And a step of storing in the analysis result data storage unit.
- the analysis result can be stored in, for example, other reagents related to this reagent. It can also be used for management.
- the method further includes a third determination step for determining the presence / absence of abnormality according to the abnormality detection condition for each sample to be analyzed.
- Information about the presence or absence of abnormalities determined in the third judgment step Information may be included.
- the method may further include a step of determining whether there is an abnormality in the entire analysis result using the data related to the analysis result. Oh ,. In this way, more appropriate analysis results can be obtained by not only determining the presence / absence of abnormality for each sample but also determining the presence / absence of abnormality for the entire analysis result. In other words, appropriate analysis can be supported.
- the step of estimating the cause of the abnormality using the data related to the analysis result and the presence or absence of abnormality in the entire analysis result And a step of presenting the data of the estimated cause of the abnormality to the user of the analyzer when it is determined that there is an abnormality.
- the user of the analyzer can perform more appropriate treatment.
- An analyzer is an analyzer that uses a reagent container having a memory for storing reagent information relating to the reagent inside the container, and is used for the memory of the reagent container.
- the memory reader / writer and the memory reader / writer are configured to read out the reagent information related to the reagent in the reagent container from the memory of the reagent container, and based on the reagent information related to the reagent in the reagent container, the reagent container And a means for transmitting at least part of the reagent information to the remote computer when the determination means determines that the reagent in the reagent container is usable. .
- the determination means causes the data indicating the unusable to be written in the memory of the reagent container, and the remote computer power reagent container
- the data indicating that the reagent is unusable is received, the data indicating that the reagent is unusable is written in the memory of the reagent container.
- means for causing the memory 'reader / writer to write the data related to the result of the analysis into the memory of the reagent container, and the data related to the result of the analysis May further comprise means for transmitting to the remote computer. Since data related to the results of prayer may also be necessary for reagent management, It writes to the memory. It is also sent to a remote computer for use in determining the validity of the analysis results.
- a second determination means for determining the presence or absence of abnormality according to the abnormality detection condition for each sample to be analyzed, and the result of the analysis
- Such data may include information on the presence or absence of an abnormality determined by the second determination means.
- Appropriate support for analysis is provided by judging the presence or absence of abnormalities in analysis.
- the data relating to the abnormality detection condition for each sample to be analyzed may be data updated by a remote computer. More appropriate abnormality detection can be performed by determining the remote computer power using, for example, the latest more appropriate data.
- it further comprises means for receiving validity data for the result of the remote computer force analysis, and means for presenting the received validity data to the user, wherein the second determination means includes the validity data
- the second determination means includes the validity data
- a remote computer is a remote computer cooperating with an analyzer using a reagent container having a memory for storing reagent information relating to the reagent inside the container, Analytical instrument power
- the use of the reagent in the reagent container is determined based on the availability condition specified from the use result of the reagent having a predetermined relationship with the reagent in the reagent container.
- Judgment means for judging propriety, means for sending the judgment result by the judgment means to the analyzer when it is judged that at least the reagent in the reagent container is unusable, and the reagent in the reagent container cannot be used by the judging means If it is determined that the data in the reagent container is unusable, data indicating that the reagent in the reagent container cannot be used is registered in the reagent database.
- condition force derived from a plurality of use cases of the same type of reagent can be determined to determine whether or not the reagent can be used, thereby enabling appropriate reagent management and operational efficiency in analysis. Can be improved.
- the judging means when it is judged by the judging means that the reagent in the reagent container can be used.
- Means for reading the latest data used in the analysis using the reagent in the reagent container for example, option information, meter and threshold data in the embodiment
- Anomaly detection in the prayer can be performed based on more appropriate data.
- means for storing the data related to the analysis result in the analysis result data storage unit, and the analysis result stored in the analysis result data storage unit There may be further provided a second judging means for judging the validity of the result of the analysis using the data related to and a means for sending the judgment result by the second judging means to the analyzer.
- the second determination means uses the data relating to the analysis result stored in the analysis result data storage unit to determine whether there is an abnormality in the entire analysis result, and for the entire analysis result.
- the validity of the analysis results may be specified based on the presence or absence of any abnormalities.
- the second determination unit may further perform a process of estimating the cause of the abnormality using data relating to the analysis result stored in the analysis result data storage unit. By estimating the cause of the abnormality, the user can be guided to appropriate treatment.
- it may further include means for generating data representing a difference between the analysis devices using a predetermined dull of the data relating to the analysis result stored in the analysis result data storage unit. .
- it may further include means for predicting the occurrence of an abnormality in the reagent or the analyzer using the data relating to the analysis result stored in the analysis result data storage unit.
- the data analysis method includes a reagent information relating to a reagent inside a container. Executed by a remote computer that cooperates with an analyzer that uses a reagent container having a memory for storing information, and if at least a part of the reagent information is received from the analyzer, the reagent
- the determination step for determining whether or not the reagent in the reagent container can be used is determined based on the conditions for determining whether or not the reagent is used based on the usage result of the reagent having a predetermined relationship with the reagent in the container.
- a program for realizing the analysis apparatus and the remote computer according to the present invention can be created, and the program is stored in, for example, a flexible disk, a CD-ROM, a magneto-optical disk, a semiconductor memory, a hard disk, and the like. Stored in a medium or storage device. In some cases, digital signals are distributed over a network. The data being processed is temporarily stored in a storage device such as a computer memory.
- the reagent container according to the fifth aspect of the present invention is capable of using the reagent in the reagent container in the analysis. At least the result of the analysis using the reagent in the reagent container is appropriate. Data used for making the analyzer determine any of them is stored, and a memory that can be read by the analyzer is provided.
- FIG. 1 is a system outline diagram in one embodiment of the present invention.
- FIG. 2 is a functional block diagram of the analyzer.
- FIG. 3 is a functional block diagram of the host computer.
- Fig. 4-1 shows the data stored in the RF tag.
- Fig. 4-2 shows the data stored in the RF tag.
- FIG. 5 is a diagram showing a first processing flow of the system.
- FIG. 6 is a diagram showing a second processing flow of the system.
- FIG. 7 is a diagram showing a third processing flow of the system.
- FIG. 8 is a diagram showing a fourth processing flow of the system.
- FIG. 9 is a diagram showing a fifth processing flow of the system.
- FIG. 10 is a diagram showing a sixth processing flow of the system.
- FIG. 11-1 is a table showing the processing results by the inter-device difference data generation unit.
- FIG. 11 2 is a table showing criteria for judging the processing result by the inter-device difference data generation unit.
- FIG. 12 is a functional block diagram of a computer.
- FIG. 1 shows a system outline diagram according to one embodiment of the present invention.
- An analyzer 3a and an analyzer 3b are connected to a network 1 such as the Internet or a dedicated line. Although only two analyzers are shown here, the number is not limited to two.
- a LAN (Local Area Network) 11 of a company or the like that provides a remote monitoring service for the analyzers 3a and 3b is connected to the network 1 through a communication device such as a firewall.
- One or more sales staff terminals 7 and one or more maintenance staff terminals 9 are connected.
- the sales staff terminal 7 and the maintenance staff terminal 9 are, for example, personal computers, and can access data stored in the host computer 5 and receive e-mails from the host computer 5.
- the reagent is held in the reagent container 31, and the reagent container 31 Has an RF (Radio Frequency) tag 311 including a memory for storing information on the reagent inside the container.
- RF Radio Frequency
- a contact type IC tag connected to a non-contact type IC (Integrated Circuit) tag like the RF tag 311 may be used.
- One or more reagent containers 31 are stored in the reagent storage unit of the analyzer 3 and used for analysis.
- FIG. 2 shows a functional block diagram of the analyzer 3.
- the analysis device 3 includes a network interface unit 38, an order processing unit 39, an order log storage unit 40, an analysis device management unit 35, a confirmation data storage unit 36, an operation status data storage unit 37, A buffer 34, a tag interface unit 33, and a reagent storage unit 32 are provided. Further, a display device (not shown) may be included.
- the reagent storage unit 32 is preferably one that has a heat insulation / cooling function.
- the reagent storage unit 32 holds one or more reagent containers 31, and the temperature and humidity in the reagent storage unit 32, and if necessary, vibration, inclination, etc.
- a tag reader / writer 321 that reads / writes data from / to the RF tag 311 of the reagent container 31.
- the tag reader / writer 321 is a well-known device configured to be compatible with the RF tag 311 and will not be described further here.
- the tag reader / writer 321 reads and writes data from and to the RF tag 311 in accordance with instructions from the tag interface unit 33.
- the sensor 322 may be provided on the reagent container 31 side, in which case it is possible to measure and record temperature, humidity, etc. when left outside the reagent storage unit 32 or during transportation. It becomes.
- the sensor 322 may be provided with a device for measuring time.
- the analyzer management unit 35 writes a command for the tag reader / writer 321 (including write data in the case of writing) to the buffer 34, and the tag interface unit 33 refers to the buffer 34 to process the tag reader / writer 321. We are going to carry out. Further, the analyzer management unit 35 reads the data written in the buffer 34 by the tag interface unit 33 and executes the processing. The analyzer management unit 35 receives the measurement result from the sensor 322 in the reagent management unit 32.
- the analyzer management unit 35 includes a reagent availability determination unit 351 and an analysis result determination unit 352, performs processing with reference to the confirmation data storage unit 36, and further transfers predetermined data to the network.
- the interface unit 38 is transmitted to the host computer 5.
- the network interface unit 38 receives the data from the host computer 5 and receives the data from the analyzer. It outputs to the science department 35.
- the analyzer management unit 35 stores data on the operating status of the analyzer in the operating status data storage unit 37, and at a predetermined timing (for example, periodically or when an abnormality is detected). 3 8 causes the host computer 5 to transmit.
- the analyzer management unit 35 causes the order processing unit 39 to execute the order processing in response to an instruction from the analyzer user.
- the order processing unit 39 stores the order log in the order log storage unit 40 for later confirmation, for example, and generates order data and transmits it to the network interface unit 38 to the host computer 5.
- the network interface unit 38 performs communication processing with the host computer 5.
- FIG. 3 shows a functional block diagram of the host computer 5.
- the host computer 5 includes a communication control unit 51, a check unit 52, an apparatus DB management unit 53, a reagent DB management unit 54, an order processing unit 55, an order database (DB) 56, and a result file.
- Front end unit having storage unit 57, rule DB 58, device DB 59, and reagent DB 60, data update unit 61, inter-device difference data generation unit 62, reagent abnormality prediction unit 63, and device abnormality prediction unit 64 And a back-end unit having an inter-device difference data storage unit 65.
- Data from each analyzer 3 is received by the communication control unit 51 and output to any of the check unit 52, the device DB management unit 53, the reagent DB management unit 54, and the order processing unit 55.
- the check unit 52 includes a reagent check unit 521, an apparatus check unit 522, and an analysis result check unit 523.
- the result DB storage unit 57, the rule DB 58, and the reagent DB management unit 54 are connected to the reagent DB 60 and the apparatus DB management unit 53.
- Data is stored in the device DB59 via, and processing is performed using the data stored in them.
- the order processing unit 55 stores the reagent or maintenance order data received via the communication processing unit 51 in the ordering DB 56 and transmits a notification to the maintenance staff terminal 9 and the sales staff terminal 7.
- the order processing unit 55 may receive order data from the check unit 52.
- the reagent DB management unit 54 stores the data from the check unit 52 or the communication control unit 51 in the reagent DB 60, and outputs the data stored in the reagent DB 60 to the check unit 52 in response to a request from the check unit 52.
- the device DB management section 53 Stores the data from the check unit 52 or the communication control unit 51 in the device DB 59, and outputs the data stored in the device DB 59 to the check unit 52 in response to a request from the check unit 52.
- the data update unit 61 performs analysis processing using the data stored in the result file storage unit 57, and updates, for example, threshold data stored in the reagent DB 60 to the latest data.
- the inter-device difference data generation unit 62 performs an analysis process using the data stored in the result file storage unit 57, compares the difference in the analysis results between the analysis devices, and compares the difference between the analysis device devices. The problem occurring in the analyzer is detected by specifying the size of the.
- the processing result is stored in the inter-device difference data storage unit 65. For example, a warning message is transmitted to the user of the maintenance terminal 9 if necessary.
- the reagent abnormality prediction unit 63 performs an analysis process using the data stored in the result file storage unit 57, detects a sign that a reagent abnormality has occurred, and displays a warning message as necessary, for example, the user of the sales representative terminal 7.
- the device abnormality prediction unit 64 performs analysis processing with reference to the result file storage unit 57 and the device DB 59, detects a sign that a device abnormality occurs, and displays a warning message as necessary, for example, the maintenance terminal 9 Send to users of.
- Figure 41 shows the information written at the time of shipment, along with whether it has been updated
- Figure 4-2 shows the information written after the shipment. More specifically, information written at the time of shipment includes information on manufacturing, information on analysis conditions, information on reagent performance, information on display, and information on results.
- the information written after shipment includes information written during use and other times, and information written during use.
- Information related to manufacturing includes information such as a manufacturing lot number, a serial number, and an expiration date. Thereby, it becomes possible to specify the reagent.
- the production port number here refers to the number assigned to each production lot at the production factory when the reagent bottle (container) is manufactured, and the serial number is assigned to each reagent bottle (container). Represents a number.
- the information on the analysis conditions includes parameters (sample use amount, reagent use amount, measurement wavelength (main wavelength and subwavelength), reaction conditions, etc., for operating the analyzer for analysis. Time, measurement point, etc.), dilution conditions (diluent type and dilution rate), and calibration method.
- the parameters differ depending on the measurement item and the sample to be analyzed.
- the sample is an object to be analyzed, and refers to a sample such as blood or urine, a calibrator for calibration, and a control for confirming the calibration result.
- the calibration method here is data relating to a specific operation condition that is shown at the time of calibration.
- calibration type type of calibration curve
- linear equation straight line
- quadratic equation spline curve
- log it-log curve etc.
- concentration value of the calibrator to be measured standard solution
- the concentration value of the calibrator to be measured standard solution
- calibration is an operation for calibrating measured values using equipment and reagents, and a calibrator means a sample for calibrating measured values and is also called a standard solution. In order to confirm the calibration result, it is necessary to measure the control as a sample having a measured value in the reference range.
- information on reagent performance includes information such as calibration information, linearity, reproducibility, influence of coexisting substances, reaction time course, stability, and threshold data. Thereby, the performance of the reagent can be specified.
- the calibration information includes the blank value, sensitivity, calibrator concentration, calibrator lot number, calibration date, expiration date, calibration history, reagent lot number and serial number used during measurement.
- the reaction time course is information on the progress of the reaction and related information.
- the information related to display includes unit, number of display digits, reference value (range) t, and other information. Thereby, setting input by the user of the analyzer can be omitted, the user's utility is improved, and the quick analysis of the analysis can be measured.
- the information related to the results includes information such as serum information and calculation between items (items, arithmetic expression, unit, number of digits). As a result, setting input by the user of the analyzer can be omitted, and the user's utility can be improved and the analysis can be speeded up.
- Some of the information written at the time of shipment described above is updated with the latest data received from the host computer 5.
- information items that are “present” for example, information on analysis conditions and information on reagent performance
- information items that are “none” For example, information on manufacturing
- the information written after shipment includes information written during use and other times, and information written during use.
- the information written during use and other information includes information on the storage status.
- the information regarding the storage status includes the transport status (temperature, humidity, time, vibration) and the storage status (temperature, humidity, time, vibration).
- the transportation status is information on temperature, humidity, and vibration data and the time required for transporting the reagent.
- the storage status is information on temperature, humidity, and vibration data at the time of reagent storage and the time required for the data.
- the data written during use includes information relating to the usage status and information relating to the result file.
- Information on the usage status includes information such as the number of times of use, time of use, time of use, expiration date, remaining amount, and availability of use. As a result, it is possible to obtain information on the availability of reagents and performance assurance.
- the information related to the result file includes environment information, performance information, and warning information.
- the environmental information includes information such as the measurement analyzer ID, measurement items, measurement status, parameters used during measurement, sample information of the measurement sample, cell blank during measurement, reaction time course information during measurement, and analysis results.
- the performance information includes measurement blank values, information on the calibration performed, control measurement results and! /, And other information.
- the analyzer management unit 35 of the analyzer 3 periodically or immediately before the start of analysis or At the timing such as when an abnormality is detected, the measurement results (temperature, humidity, etc.) from the previous writing by the sensor 322 are collected as storage status information and output to the buffer 34 together with the writing instruction (step Sl).
- the buffer 34 stores save status information and write instruction data.
- the tag reader / writer 321 receives the storage status information and the write instruction stored in the buffer 34 via the tag interface unit 33, and records the storage status information in the RF tag 311 (step S3).
- the analyzer 3 has the reagent storage unit 32 having the cold storage function, and the user stores the reagent in the reagent storage unit 32 when in use.
- the analyzer management unit 35 stores, for example, data acquired from the sensor 322 in the operation status data storage unit 37 as appropriate, and this information stored in the operation status data storage unit 37 in step S1. Use to indicate the writing.
- the analyzer management unit 35 of the analyzer 3 outputs a reagent information read request to the buffer 34 before starting the analysis (step S7).
- the buffer 34 stores a reagent information read request.
- Step S7 is executed at some selection input by the user before the analysis is started, or in some cases at the timing of setting the reagent container 31.
- the tag reader / writer 321 receives a reagent information read request from the buffer 34 via the tag interface unit 33, reads the reagent information from the RF tag 311 and outputs the reagent information to the buffer 34 via the tag interface unit 33 (step S9).
- the noffer 34 stores reagent information.
- the analyzer management unit 35 acquires the reagent information stored in the notfer 34 (step Sl l).
- the reagent information includes information written at the time of shipment, information on the storage status, and information on the usage status stored in the RF tag 311.
- the reagent availability determination unit 351 of the analyzer management unit 35 determines whether or not a predetermined usage disable condition is satisfied using the reagent information (step S13).
- a predetermined usage disable condition is satisfied using the reagent information (step S13).
- unusable conditions Is insufficient reagent, expiration date, reagent information reading failure, prohibited use reagent, storage temperature and / or humidity abnormalities.
- vibrations and reagent container tilt abnormalities may be used as unusable conditions.
- Insufficient remaining amount can be determined by the remaining amount of reagent included in the reagent information.
- the expiration date can also be determined by comparing the system time with the expiration date included in the reagent information.
- the reagent information reading failure can be determined based on whether or not the data output to the buffer 34 in step S9 is data indicating “reading failure”. Since the lot number and serial number are stored in the confirmation data storage unit 36 for the reagent whose use is prohibited, it is identified by comparing the data with the lot number and serial number included in the reagent information. In addition, regarding storage temperature and / or humidity abnormalities, store within the specified temperature range, humidity range, temperature range, and humidity range during transportation and storage based on information related to storage conditions included in the reagent information. Or how many hours it has been left outside the specified temperature range, outside the humidity range, or both. The predetermined temperature range and humidity range are stored in the confirmation data storage unit 36.
- the reagent availability determination unit 351 determines the force with which the reagent can be used (step S15). If it is determined that it can be used based on a predetermined unusable condition (step S15: Yes route), the processing shifts to the processing in FIG. When it is determined that the reagent cannot be used based on the predetermined unusable condition (Step S15: No route), the reagent usable / unusable determination unit 351 outputs the data indicating that the reagent is unusable and the write instruction to the buffer 34. (Step S17). The noffer 34 stores data indicating that it cannot be used and the instruction to write the data.
- the tag reader / writer 321 receives the data indicating the unusable and the write instruction thereof via the tag interface unit 33, and transmits the data representing the unusable (usable / unusable information; the same applies hereinafter) to the RF tag 311. (Step S19). However, if it is determined that the reagent information cannot be read due to failure in reading the reagent information, writing may not be possible, so steps S 17 and S 19 may be skipped.
- the reagent usability determination unit 351 causes the network interface unit 38 to transmit reagent specific data (reagent type, lot number and serial number) and data indicating unusable to the host computer 5 (step S21). ).
- Communication control unit of host computer 5 When 51 receives the reagent specifying data and the data indicating that it cannot be used from the analyzer 3, it outputs the reagent DB management unit 54 to register it in the reagent DB 60 (step S23).
- Information on all shipped reagents is registered in the reagent DB60. That is, the information written at the time of shipment and the availability flag for the reagent in each reagent container are stored. In addition, shipping destination data may be included.
- the reagent in the specific reagent container is identified based on the reagent specifying data, and the use enable / disable flag is set to disable correspondingly.
- the communication control unit 51 of the host computer 5 outputs reagent specifying data and unusable data to the order processing unit 55, for example. Then, the order processing unit 55 does not determine the order, but transmits a warning message indicating that a problem has occurred with respect to the reagent to, for example, the user of the sales staff terminal 7 (step S25). It should be noted that order processing may be performed automatically at this stage.
- the reagent availability determination unit 351 displays a message recommending reagent replacement on the display device of the analyzer 3 (step S27). Also, for example, on the screen that displays a message recommending reagent replacement, it is recommended that a button for ordering replacement reagent be provided and the user press the button. Then, the order processing unit 39 automatically stores an order log relating to the replacement reagent order in the order log storage unit 40 in accordance with the order of replacement reagent order or, in some cases, regardless of the order.
- the network interface unit 38 is caused to transmit replacement reagent order data to the host computer 5 (step S29). Replacement reagent order data includes reagent type data.
- the communication control unit 51 of the host computer 5 receives the order data from the analysis device 3 and outputs it to the order processing unit 55.
- the order processing unit 55 performs order processing such as registering the order data in the order DB 56 based on the order data (step S31). Further, the order processing unit 55 performs notification by transferring order data to the user of the sales staff terminal 7 (step S33). As a result, the sales staff can perform appropriate processing at an early stage.
- the order DB56 allows the reagent manufacturer to carry out inventory management and production management.
- the predetermined unusable condition may include a reagent error. This is done When the reagent used in the analysis is specified and the reagent used is not set in the reagent storage unit 32, it is detected. However, it may be inappropriate to write the data indicating that it cannot be used to the RF tag 311. Therefore, if a reagent error is detected, only a replacement recommendation may be implemented.
- the reagent availability determination unit 351 of the analyzer management unit 35 determines that the reagent can be used based on a predetermined unusable condition
- the device information of the analyzer 3 and the reagent identification data are hosted in the network interface unit 38.
- the device information includes an analysis device ID and data (measurement data by the sensor 322 and analysis execution status data) stored in the operation status data storage unit 37.
- the communication control unit 51 of the host computer 5 receives the device information and the reagent specifying data from the analyzer 3 (step S37), and outputs the received data to the reagent check unit 521 and the device check unit 522.
- the reagent check unit 521 reads the accumulation confirmation data from the reagent DB 60 via the reagent DB management unit 54, and uses the accumulation confirmation data to determine whether the reagent in the reagent container specified by the reagent identification data can be used.
- Confirm step S39.
- Accumulation confirmation data includes the latest list of combinations of lot numbers, lot numbers, and serial numbers of reagent containers that cannot be used. Since the list of combinations of lot numbers, lot numbers and serial numbers held in the analyzer 3 may be old, step S39 is executed.
- an analyzer such as an analyzer ID is specified for the combination of lot number, lot number, and serial number.
- the data to be used is associated and the set is registered in the list.
- the reason data is also registered. Therefore, the reagent check unit 521 checks the latest list using the reagent specifying data and the device information.
- the reagent check unit 521 searches the reagent having the same reagent and the same lot number for data that is determined to be unusable, and the result of the search is the reagent specified by the reagent specifying data. Check (determine) the force that may be disabled (is included in the list determined to be unusable). The list of reagents that are judged to be unusable is shown in the reagent abnormality prediction section. Can be generated by analyzing the data stored in the result file storage unit 57.
- reagent DB60 An example where a specific reagent lot is determined to be unusable is when the number of reagents that cannot be used with a reagent with the same lot number exceeds 5% of the total number of reagents with the same lot number. Can be determined. This list of reagents that are determined to be unusable is stored in reagent DB60.
- the reagent check unit 521 determines that the reagent specified by the reagent specifying data is unusable (step S41: No route)
- the reagent check unit 521 instructs to write data indicating the unusable to the RF tag 311 and
- the reason data is transmitted to the analyzer 3 by the communication control unit 51 (step S43).
- the network interface unit 38 of the analyzer 3 receives a data write instruction and reason data indicating the unusable from the host computer 5 and outputs them to the analyzer management unit 35.
- the analyzer management unit 35 displays a message indicating the unusability and reason data on the display device (step S45).
- the data indicating that the data cannot be used and the write instruction are output to the buffer 34 (step S47).
- the nofer 34 stores the data indicating the unusable and the write instruction thereof.
- the tag reader / writer 321 receives the data indicating the unusable and the write instruction thereof via the tag interface unit 33, and records the data representing the unusable in the RF tag 311 (step S49). The process proceeds to terminal S 29 in FIG.
- the reagent check unit 521 sets the usability flag corresponding to the reagent specifying data to unusable in the reagent DB 60, and registers the reason data (step S51). After this, the processing after step S25 may be performed.
- the reagent checking unit 521 determines that the reagent specified by the reagent specifying data can be used (step S41: Yes route)
- the reagent checking unit 521 refers to the reagent DB 60 via the reagent DB management unit 54.
- the latest option information, meter and threshold data (hereinafter abbreviated as latest data) are read out for the relevant reagent (step S53).
- Optional information is information that must be used in combination with a specific reagent item or reagent lot, for example, information on a combination of a reagent lot and a calibrator lot.
- the threshold data is as follows.
- the first threshold data used in the analysis apparatus 3 and the second threshold data used in the host computer 5 are included.
- the first threshold data is read out.
- the first threshold data includes a reagent blank threshold (for example, an absorbance of 0.1 or less), a calibrator measurement value threshold (for example, an absorbance of 0.6 or more and 0.9 or less), a cell blank data threshold, and a time course data threshold.
- the reagent check unit 521 determines whether data update has been performed on the data read as the latest data (step S55). There is no update at all! /, Because there is no point in sending. For example, if the latest data transmission history is registered in the reagent DB 60, etc., it is determined whether there is an unsent update by referring to the reagent DB 60. If it is determined that there is data update (step S55: Yes route), the communication control unit 51 is caused to transmit the latest data of the reagent specified by the reagent specifying data to the analyzer 3 (step S57).
- the network interface unit 38 of the analyzer 3 When receiving the latest data of the reagent specified by the reagent specifying data from the host computer 5, the network interface unit 38 of the analyzer 3 outputs it to the analyzer management unit 35.
- the analyzer management unit 35 stores the latest data of the reagent specified by the reagent specifying data in the confirmation data storage unit 36, and outputs the latest data and its write instruction to the buffer 34 (step S59).
- the buffer 34 stores the latest data and its write instruction.
- the tag reader / writer 321 receives the latest data and write instruction via the tag interface unit 33, and records the latest data in the RF tag 311 (step S61).
- step S55 No route
- the device check unit 522 determines whether there is a device abnormality from the received device information (step S63). For example, check whether the operational status data includes data indicating sensor abnormalities and other part abnormalities. The determination of whether there is a device abnormality in step S63 can be performed at any time regardless of the analysis. If it is determined that there is no abnormality (step S65: No route), the device check unit 522 generates a normal message and causes the communication control unit 51 to transmit it to the analyzer 3 (step S67). . Network-in of analyzer 3 When receiving a normal message from the host computer 5, the interface unit 38 outputs it to the analysis device management unit 35. The analyzer management unit 35 displays a normal message on the display device (step S69). Then, the process proceeds to the process in FIG.
- step S65 when it is determined that there is an abnormality (step S65: Yes route), the device check unit 522 generates a warning message about the device abnormality and transmits it to the communication control unit 51 to the analysis device 3.
- the network interface unit 38 of the analyzer 3 receives a warning message about the device abnormality from the host computer 5 and outputs it to the analyzer management unit 35.
- the analyzer management unit 35 displays a warning message about the device abnormality on the display device (step S73). The analyzer user may see the warning message, take appropriate measures to resolve the instrument error, and start the analysis (when moving to the process in Fig. 8 via terminal C).
- maintenance order instructions may be input, such as pressing the maintenance order button provided along with the warning message display screen.
- the analysis device management unit 35 of the analysis device 3 Upon receiving a maintenance order instruction from the user, the analysis device management unit 35 of the analysis device 3 generates maintenance order data specifying the abnormal part, stores it in the order log storage unit 40, and stores it in the network interface unit 38. Transmit to the host computer 5 (step S79).
- the communication control unit 51 of the host computer 5 receives the maintenance order data from the analyzer 3 and outputs it to the order processing unit 55.
- the order processing unit 55 performs order processing such as registering the received maintenance order data in the order DB 56 (step S81). For example, the maintenance order data is transferred to the user of the maintenance terminal 9 to notify that the maintenance order has been placed (step S83).
- step S71 device check unit 522 registers data representing device abnormality in device DB 59 (step S75).
- the apparatus DB 59 an analysis apparatus ID, a status flag indicating normality or abnormality, operational status data, date and time of occurrence of abnormality, and its cause data are registered.
- the status flag is set to indicate an abnormality, and cause data (reason data determined to be abnormal) is registered together with the date / time data.
- maintenance order data may be automatically transmitted from the apparatus check unit 522 to the order processing unit 55.
- the order processor 55 Perform maintenance order processing in the same way as other maintenance order data (step s)
- the occurrence of a device abnormality may be notified to the user of the maintenance terminal 9.
- the user of the analyzer 3 sets a sample to be analyzed in the analyzer 3 and instructs the start of analysis.
- the analysis device management unit 35 of the analysis device 3 accepts an analysis start instruction with user power (step S85). Then, the analyzer management unit 35 starts analysis using the reagent information stored in the confirmation data storage unit 36 and the reagent itself. Then, the analysis result determination unit 352 reads the first threshold data from the confirmation data storage unit 36, and determines whether there is an abnormality during analysis using the first threshold data (step S87). In step S87, the presence or absence of abnormality during analysis is determined for each sample.
- the first threshold data included in the reagent information read from the RF tag 311 is used.
- the time course of a specific measurement item for example, if the equilibrium time of the reaction time course is set as a threshold within 5 minutes after the start of the reaction, the equilibrium of the measured reaction time course is reached. If the time is 6 minutes, it is judged that there is an abnormality at the time of analysis.
- step S89 If an abnormality is detected by the determination (step S89: Yes route), the occurrence of the abnormality is displayed on the display device and notified to the user (step S91). Step S91 is executed every time an abnormality is detected. If no abnormality is detected by the determination (step S89: No route), or if there is an abnormality, the analysis result is analyzed after step S91 (step S93). This is a normal process of the analyzer and will not be discussed further. Then, a result file is generated at the end of the analysis and stored in, for example, the buffer 34 (step S95). The contents of the result file are displayed on the display device of the analyzer 3 (there may be some cases).
- any case that is, when an abnormality is not detected at the time of analysis and the measurement is completed normally, an abnormality is detected at the time of analysis, but the measurement itself is completed, or an abnormality is detected at the time of analysis.
- the measurement result is not obtained and the process is terminated (including the case where the analyzer 3 automatically stops the analysis and the case where the user stops the analysis in response to the display of the occurrence of the abnormality), etc.
- the analysis is complete. " Result
- the result file contains environmental information, performance information, and warning information if an abnormality is detected.
- environmental information includes analyzer ID, measurement item, measurement status, parameters used this time, sample information of the sample measured this time, cell blank of this time (cell (reagent used for measurement) (This indicates the degree of contamination of the cell.), The current time course information, and analysis results (actual measurement information).
- the specimen information includes the test ID and the related information such as specimen identification ID, type (blood, urine, etc.), color tone (distinguish between hemolyzed, milky milk, pyrilbin specimen, etc.) and viscosity.
- the actual measurement value information includes information on a comparison result with an actual measurement value before calibration, a measurement value after calibration, and a reference value (range).
- the performance information includes the current measurement blank value, the calibration information performed this time, and the current control measurement result, as described in Fig. 42.
- the warning information includes information regarding user operation errors, reagent abnormalities, analyzer abnormalities, result abnormalities, and information for determining them (for example, threshold data).
- the analysis result determination unit 352 outputs the result file and its writing instruction to the buffer 34 (step S97).
- the noffer 34 stores the result file and its write instruction.
- the tag reader / writer 321 receives the result file and its write instruction via the tag interface unit 33, and records the result file in the RF tag 311 (step S99).
- the analysis result determination unit 352 validates the analysis result.
- the result file is transmitted to the host computer 5 by the network interface unit 38 for sex determination (step S103).
- the communication control unit 51 of the host computer 5 receives the result file from the analyzer 3 and outputs it to the analysis result check unit 523 of the check unit 52.
- the analysis result check unit 523 stores the result file in the result file storage unit 57 (step S105).
- the analysis result determination unit 352 displays the analysis result on the display device (step S107). The subsequent processing shifts to the processing in FIG.
- step S101 No route
- the analysis result determination unit 352 performs analysis in a state where the measurement result is not obtained. It is useless to judge the validity in the result check unit 523, so the result file is sent to the network interface unit 38 for host reporting only to report the analysis result.
- Step S109 The communication control unit 51 of the host computer 5 receives the result file from the analysis device 3 and stores the result value in the result file storage unit 57 via the check unit 52 when the measured value information is empty (for example, Null). (Step Sl ll).
- the communication control unit 51 sends a result file to the order processing unit 55.
- the order processing unit 55 may automatically perform maintenance order processing for the analysis apparatus 3 that is the transmission source of the result file! (Step S113).
- step S115 Yes route
- step S115: No route the process returns to step S85, and if remeasurement is not performed (step S115: No route), the terminal E is connected via the terminal E in FIG. Move on to step S79.
- Minor abnormalities mean abnormalities caused by user's misoperation, for example, abnormal measurement values due to incorrect sample or reagent usage, insufficient sample volume, etc. For example, a device abnormality that can be easily removed by a user such as being caught.
- the analysis result check unit 523 reads the second threshold data stored in the reagent DB 60 via the reagent DB management unit 54 (step S117).
- the second threshold data is data for determining whether the entire analysis result is valid. More specifically, it includes a reagent blank threshold, a threshold for a calibrator measurement value, a threshold for a control measurement value, specimen information, a cell blank data threshold, a time course threshold, a time course data threshold, and the like. Then, the analysis result check unit 523 uses the second threshold data, and further uses the data stored in the result file storage unit 57 as necessary to check whether the analysis result is valid and valid. If not, it is determined whether re-measurement is necessary (step S119).
- step SI 19 in relation to the reagent blank threshold, comparison at the start and end of the measurement, comparison with the previous time, check for aging, and other reagents with the same lot number as the reagent used.
- the effectiveness of the analysis results is judged by comparing with measurement data (eg, reagent blanks over time) and by comparing with data on other analyzers.
- the effectiveness of the analysis results is judged by comparing with the measurement data of other reagents (for example, checking the measured values of calibrators over time, etc.) and comparing with data on other analyzers.
- the comparison with the threshold value for the actual measurement value before calibration the comparison with the threshold value for the measurement value after calibration, the comparison with the previous time for the control sample, the check for temporal variation, the used reagent and Comparison with measurement data of other reagents with the same lot number (for example, check of control measurement values over time), comparison with other control lot data (such as checks for changes over time), and other analysis devices
- the effectiveness of the analysis results is judged by comparing with the data.
- the validity of the analysis results is judged by checking changes over time and comparing data with other analyzers in relation to the threshold for cell blank data.
- the validity of the analysis results is judged by comparing with the threshold for the time course data, comparing with the previous time, checking with time, and comparing with data on other analyzers. In this way, necessary result files other than the current result file are also read from the result file storage unit 57 and used in this processing.
- step S119 determination by reagent blank data is taken as an example.
- the average reagent blank increase value of the same reagent as the reagent lot used in the analysis is For a reagent with a data value of 5 and an upper limit of the same threshold set to a data value of 10, the analytical results were also obtained.
- the blank increase value per week for the reagent currently in use was the data value of 12. In this case, it is determined that the analysis result subjected to the determination with respect to the reagent blank data is not effective. Similarly, for other data related to the reagent blank, the effectiveness can be determined using those threshold values. [0084] Further, there are cases where a plurality of threshold values are defined.
- a threshold value for defining the attention level and a threshold value for defining the level indicating no effectiveness are provided. For example, if the threshold value for defining the level of ineffectiveness is exceeded (or below), the threshold value for determining the level of attention is exceeded (or below). The final validity is determined based on the combination with other determination results and the number of times the attention level is detected.
- the threshold value may be set to 3 or more. In that case, points according to the severity of the attention level are specified, and the total value of the points according to the detected attention level is more than the predetermined value.
- Various modes are possible, such as determining that the result is not effective.
- step S121 If the analysis result check unit 523 determines that there is no validity in step S119, the analysis result check unit 523 refers to the rule DB 58 to estimate the cause (step S121). If it is determined in step S119 that there is validity, step S121 is not executed because it is not necessary to estimate the cause.
- the cause is estimated from the analysis results (or measurement results) of individual specimens using, for example, rule data stored in the rule DB 58, and the causes are aggregated for the analysis results of all specimens.
- the cause is estimated for the reagent or the analyzer using another rule data stored in the rule DB 58.
- the cause may be identified by applying the rule data stored in rule D B58, which has acquired past performance, according to the occurrence ratio and combination of causes other than the most frequently occurring cause. .
- the analysis result check unit 523 causes the communication control unit 51 to transmit the determination result in steps S119 and S121 to the analysis device 3 (step S123).
- the determination result is stored in the result file storage unit 57 corresponding to the result file, and if it is determined that there is no validity, the reagent availability flag of the reagent cannot be used in the reagent DB 60 if the reagent is the cause. If the cause is the analyzer, the status flag is abnormally set for the analyzer in the device DB59 (step S127).
- Device DB59 contains date and time And cause data are also registered. The cause data may be registered in the reagent DB60.
- the network interface unit 38 of the analyzer 3 receives the determination result data from the host computer 5 and outputs it to the analysis result determination unit 352 of the analyzer management unit 35 (step S125).
- the analysis result determination unit 352 displays the received determination result data on the display device of the analysis device 3 (step S125), and determines whether the determination of validity has been obtained (step S129). If it is determined that there is validity, the reagent information update information and the writing instruction thereof are output to the buffer 34 (step S131).
- the noffer 34 stores the update information of the reagent information and the writing instruction thereof.
- the update information of the reagent information includes the reagent remaining amount and the like. However, the validity judgment result of this analysis result file may be written in this step.
- the tag reader / writer 321 records the update information of the reagent information received via the tag interface unit 33 in the RF tag 311 (step S 133).
- step S135 the force determined to be re-measured is checked. If it is determined that re-measurement is necessary, it is judged that the power has been re-measured twice or more (step S137). If re-measurement is performed once, return to Step S85 in FIG. Before proceeding to step S85, for example, the force counter for counting the number of remeasurements is incremented by one. On the other hand, if the remeasurement is performed twice or more, a warning message may be displayed on the display device of the analyzer 3 and the process may be terminated (step S139). On the other hand, if it is determined that re-measurement is unnecessary, the processing shifts to the processing in FIG.
- the analysis result determination unit 352 checks whether the determination result includes a reagent failure as a cause (step S141). If it is estimated that a reagent failure is the cause, the data indicating that the reagent cannot be used and its write instruction are output to the buffer 34 (step S143).
- the nofer 34 stores data indicating that it cannot be used and its write instruction.
- the tag reader / writer 321 receives the data indicating the unusable and the write instruction thereof from the buffer 34 via the tag interface unit 33, and records the data representing the unusable in the RF tag 311 (step S145).
- the analysis result determination unit 352 displays a message recommending reagent replacement on the display device of the analyzer 3 (step S1 47).
- step S 149 the analysis result determination unit 352 confirms whether or not the determination result includes the abnormality of the analyzer 3 (step S 149). If the cause is presumed to be due to an abnormality in the analyzer 3, a message recommending maintenance is displayed on the display device of the analyzer 3 (step S151). Then, the processing shifts to step S 79 in FIG.
- the analysis result determination unit 352 displays a message recommending removal of the defect on the display device of the analyzer 3 (step S1 53).
- the defect is, for example, a defect of a calibrator or an abnormality of a sample.
- the knock-end processing includes processing by the data update unit 61, the inter-device difference data generation unit 62, the reagent abnormality prediction unit 63, and the device abnormality prediction unit 64.
- the data update unit 61 updates the first and second threshold data using the data stored in the result file storage unit 57 and stores the first and second threshold data in the reagent DB 60. For example, in the case of the threshold value for the control measurement value, the data update unit 61 removes the same reagent lot, the period during which the data was measured, and data determined to be abnormal from the result file storage unit 57. Below, process target data is extracted. Then, a predetermined statistical process is performed to determine new threshold value data. For example, when the threshold data is determined as (average value 3 X standard deviation) to (average value + 3 X standard deviation), the average value and standard deviation are calculated and the threshold value is calculated according to the above formula. calculate.
- the new threshold data which is the calculation result, is stored in the reagent DB 60. This calculation is performed at any time, and When registered, the first threshold value is transmitted to the analyzer 3, and the second threshold value is used in the analysis result check unit 523 for each analysis. Therefore, judgment is made using the latest data.
- the processing method, determination method, criteria, and the like may differ depending on the data to be updated and the measurement items.
- the inter-device difference data generation unit 62 is a function for quality control between analysis devices, and performs processing with reference to the result file storage unit 57.
- the processing contents will be described by taking as an example the case of checking the difference between analyzers using the control measurement result included in the calibration information.
- the control measurement result is extracted from the result file storage unit 57 under predetermined conditions set for the measurement date, measurement item, reagent lot, control lot, and the like.
- predetermined statistical processing for example, calculation of the absolute value of the difference from the average value
- each analyzer is determined based on the result of the statistical processing (the magnitude of the absolute value of the difference). For example, as shown in FIG.
- the data value corresponding to the device ID is specified, and after calculating the average value, I data value—average value I is calculated.
- I data value—average value I is calculated.
- the determination result is stored in the inter-device difference data storage unit 65. Then, the determination result may be transmitted to the analyzer 3 so that the determination result is notified to the user of the analyzer 3. Further, for example, for the analysis device 3 determined to have a large difference between the analysis devices, a warning message may be transmitted to the user of the maintenance terminal 9.
- the order processing unit 55 may be formally executed with the maintenance order processing.
- the reagent abnormality predicting unit 63 uses the data stored in the result file storage unit 57 to determine a tendency such as a determination of ineffectiveness or an increase in detection of abnormality for a specific reagent lot, Perform processing such as estimating the occurrence of reagent abnormality. As a result, for example, if the occurrence of a reagent abnormality is estimated with a probability exceeding a predetermined standard in the unusable reagent list in the reagent DB 60, the reagent lot number is registered.
- the device abnormality prediction unit 64 is stored in the result file storage unit 57 and the device DB 59.
- the data is used to determine the tendency of an increase in the number of detected abnormalities for a specific type of analyzer, and to perform a process such as estimating the occurrence of an analyzer error. as a result
- a reagent abnormality prediction unit 63 and an apparatus abnormality prediction unit 64 that use data stored in the result file storage unit 57 are provided so that a specific reagent lot and serial number can be predicted before an abnormality occurs.
- the life of the reagent and the life of the analyzer can be predicted, and the reliability of the entire analysis system can be improved. It also facilitates reagent production management and inventory management. Further, since the user of the analyzer 3 can deal with the abnormality before it occurs, a reduction in the complaint rate is expected.
- an inter-device difference data generation unit 62 that uses the data stored in the result file storage unit 57 is provided, and the difference data between the analysis devices can be collected. Measures to reduce the difference between analyzers (including setting correction coefficients) can be made at any time, and the accuracy of data can be improved.
- order data is stored in the order DB 56 by the order processing unit 55
- production management and inventory management can be performed using this data.
- analyzer Information useful for reagent manufacturers and analyzer manufacturers such as extracting improvements It ’s like being able to get
- the host computer 5 can realize the functions described above with a plurality of computers instead of a single computer. Further, the functional sharing between the analyzer 3 and the host computer 5 can be changed to some extent. For example, the host computer 5 may make all judgments regarding the availability of reagents before analysis, or the latest necessary data may be sent to the analyzer 3 and all judged by the analyzer 3. It is okay to send the results to the host computer 5. Similarly, the determination of the analysis result after the analysis can be performed entirely by the host computer 5 V, and the necessary data is transmitted to the analysis device 3 and executed by the analysis device 3 for analysis. The result may be sent to the host computer 5.
- a sensor such as temperature may be provided in the reagent container 31.
- an abnormality such as detecting an abnormality in the sensor 322 is possible.
- Other functions may be added to the reagent container 31.
- the host computer 5, the sales staff terminal 7 and the maintenance staff terminal 9 are computer devices as shown in FIG. 12, in which the memory 201, CPU 203, hard disk drive (HDD) 205, a display control unit 207 connected to the display device 209, a drive device 213 for the removable disk 211, an input device 215, and a communication control unit 217 for connecting to a network are connected by a bus 219.
- An operating system (OS) and an application for realizing the above functions are stored in the HDD 205 and read out from the HD D 205 into the memory 201 when executed by the CPU 203.
- the CPU 203 controls the display control unit 207, the communication control unit 217, and the drive device 213 to perform necessary operations.
- data in the middle of processing is stored in the memory 201, and stored in the HDD 205 if necessary.
- Such a computer realizes the various functions described above by organically cooperating the hardware such as the CPU 203 and the memory 201 described above with the OS and necessary application programs.
- the analysis device 3 also has the same analysis function as before, and the tag storage / writer 32 is provided with a tag reader / writer 321 to ensure an interface with the RF tag 311.
- the tag interface unit 33, nofer 34, analyzer management unit 35, confirmation data storage unit 36, operating status data storage unit 37, order processing unit 39, order log storage unit 40, and network interface unit 38 are shown in the figure. It can also be realized by a computer device as shown in FIG.
- Order processing section 40 Order log storage section Reagent availability determination unit 352 Analysis result determination unit Communication control unit 52 Check unit
- Equipment DB management section 54 Reagent DB management section Order processing section 56 Order DB
- Reagent check unit 522 Device check unit Analysis result check unit
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Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/632,710 US8772037B2 (en) | 2004-07-22 | 2005-07-22 | Analysis assisting method, analyzer, remote computer, data analyzing method, program, and reagent container |
JP2006529296A JP4697140B2 (ja) | 2004-07-22 | 2005-07-22 | 分析支援方法、分析装置、遠隔コンピュータ、データ解析方法及びプログラム並びに試薬容器 |
EP05761816.7A EP1772736B1 (en) | 2004-07-22 | 2005-07-22 | Analysis assisting method, analyzer, remote computer, data analyzing method, program, and reagent container |
US14/298,451 US9222950B2 (en) | 2004-07-22 | 2014-06-06 | Analysis assisting method, analyzer, remote computer, data analyzing method, program, and reagent container |
Applications Claiming Priority (2)
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JP2004214695 | 2004-07-22 | ||
JP2004-214695 | 2004-07-22 |
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US11/632,710 A-371-Of-International US8772037B2 (en) | 2004-07-22 | 2005-07-22 | Analysis assisting method, analyzer, remote computer, data analyzing method, program, and reagent container |
US14/298,451 Division US9222950B2 (en) | 2004-07-22 | 2014-06-06 | Analysis assisting method, analyzer, remote computer, data analyzing method, program, and reagent container |
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Publication Number | Publication Date |
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WO2006009251A1 true WO2006009251A1 (ja) | 2006-01-26 |
Family
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PCT/JP2005/013487 WO2006009251A1 (ja) | 2004-07-22 | 2005-07-22 | 分析支援方法、分析装置、遠隔コンピュータ、データ解析方法及びプログラム並びに試薬容器 |
Country Status (4)
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US (2) | US8772037B2 (ja) |
EP (2) | EP1772736B1 (ja) |
JP (2) | JP4697140B2 (ja) |
WO (1) | WO2006009251A1 (ja) |
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US8772037B2 (en) | 2014-07-08 |
US9222950B2 (en) | 2015-12-29 |
EP1772736B1 (en) | 2013-07-03 |
US20140288854A1 (en) | 2014-09-25 |
EP1772736A4 (en) | 2012-03-14 |
JP5365615B2 (ja) | 2013-12-11 |
JP2011053229A (ja) | 2011-03-17 |
JPWO2006009251A1 (ja) | 2008-05-01 |
EP1772736A1 (en) | 2007-04-11 |
US20070255756A1 (en) | 2007-11-01 |
EP2618159A1 (en) | 2013-07-24 |
JP4697140B2 (ja) | 2011-06-08 |
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