JP2008032751A - Analysis result managing method and device - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an analysis device for objectively evaluating the possibility of abnormal data such as reagent deterioration or the like to continuously actualize highly reliable analysis by collating past analysis data gathered in a center with actual analysis data. <P>SOLUTION: Before using the analysis device for executing analyzing operation, a past analysis data group is acquired from the center in accordance with the identification code of a set reagent bottle. When the analysis result is output, results of statistic evaluation from the analysis data group are displayed as a material for the reliability of the analysis results. The analysis results gathered from a wide range into the center and its evaluation are used as materials for evaluating the present analysis results. Thus, the possibility of abnormal data for reagent deterioration or others is objectively evaluated to continuously obtain highly reliable analysis results. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention relates to an analysis result management method and management apparatus related to a reagent solution used when analyzing an analysis item in an automatic chemical analyzer or an automatic immunoanalyzer, and in particular, an analysis result when a plurality of reagent solutions are handled. The present invention relates to a management method and apparatus. In general, the present invention is also applied to an analyzer that performs an analysis using a reagent.

  When analyzing a biological sample, the reagent corresponding to the analysis item to be inspected in the sample and the sample are mixed to obtain a reaction solution, and the optical properties of the reaction solution are measured to calculate the concentration of the analysis item It is common. As a method of supplying a reagent solution to a reaction vessel on a reaction line according to an analysis item, there are a method using a pipettor using a reagent suction / discharge nozzle and a method using a dispenser using a reagent flow tube. In either case, high-reliability technology centered on reagents, such as prevention of reagent deterioration, is required.

  Patent Document 1 is known as such an example. This prior art describes a reagent management method that records and manages an identification code of a reagent bottle that has been used once, and detects and warns of a reagent deterioration reason such as addition of a deteriorated reagent. That is, the identification code of the used reagent bottle is stored in the memory, and its use is prohibited when the same bottle is set on the reagent disk of the analyzer again.

JP-A-9-26425

  According to the above-described prior art, more accurate analysis management can be performed by managing the number of analyzable times for each reagent bottle and preventing data abnormality due to reagent deterioration caused by addition of reagents.

  However, the means for maintaining and supporting the high accuracy of the analyzer is not limited to reagent bottle management. For example, in the calibration that analyzes a standard sample with a known concentration in order to create a calibration curve, if the result is inconvenient, the inconvenience may be propagated to the subsequent sample test using the calibration curve, which may hinder the accuracy of the analysis. . It is also inconvenient for determining the analysis result of this control sample when analyzing a sample (control sample) with a known concentration at regular intervals within a series of sample tests and checking whether the value is within the correct variation range. If there is, it can hinder the accuracy of the analysis as well. Furthermore, in general sample analysis (including urgent samples), a specific reaction due to the specificity of the sample may occur (see Japanese Patent Laid-Open No. 6-213893). Accuracy can be hindered.

  Conventionally, these are all determined by the analyst based on the experience of the apparatus in the facility. For example, in calibration, whether the analysis is correct or not is determined based on how far the previous calibration result is, and the analysis result of the control sample is analyzed according to the degree of variability as seen from the previous analysis group of control samples. Judge correctness. In addition, for a specific reaction in a general sample, the reaction curve is visually observed, and this correctness is determined from the experience in the laboratory so far. In any case, it was necessary to rely on subjective judgments inside the examination room, and it was impossible to introduce objectivity and generality into the judgments.

  The object of the present invention is to objectively evaluate the possibility of data abnormality such as reagent deterioration by collating past analysis data aggregated from multiple analyzers that can include analyzers of other facilities with actual analysis data. An object of the present invention is to provide an analyzer that can continuously achieve highly reliable analysis.

  The present invention collects analysis result data from a plurality of analyzers in advance and accumulates them in a determination support center when dispensing a reagent corresponding to an analysis item into a reaction container of the analysis device and analyzes the determination support information. When the reagent solution tank is installed in the reagent installation section of the analyzer in a state where it can be acquired from the support center, the determination support information is acquired based on the identification information of the reagent, and the result determination support in the analysis using the reagent The determination support information is used as a material. Here, preferably, the analysis result data includes an absorbance value before concentration conversion, a concentration value, a parameter of a calibration curve for concentration conversion (for example, a slope of a calibration line), and qualitative determination information (true The determination support information includes the analysis result data itself or its processing information (for example, statistical values such as average values and standard deviation values). Further, the analyzer directly connected to the determination support center is not limited to the analyzer, and may be a terminal device including a display device and a setting device that can input and output information equivalent to the analyzer device.

  The determination support center is connected to a reagent provider or a device provider via a communication path, thereby providing the determination support center with information held by the supplier such as reagent characteristics and device characteristics. A configuration used for the determination support information is also conceivable. In this case, the trader can obtain the usage status of the reagent or device from the determination support center.

  Furthermore, in order for the person in charge of analysis in the analysis apparatus to receive determination support, a configuration in which past analysis result data existing in the determination support center is searched, extracted, and viewed is conceivable. Also, by sending the questions of the analysts to the Judgment Support Center, inquiries are made to the traders connected to the Judgment Support Center and the analysts of other analyzers to obtain answers, and the judgment is given to the questioners. A configuration that answers from the support center is also possible. In this case, the question and answer information can also be stored in the determination support center and used as determination support information.

  According to the present invention, it is possible to evaluate the current analysis results using the analysis results and evaluations collected from a wide area in the center as objectives, so objectively evaluate the possibility of data abnormality such as reagent deterioration, Highly reliable analysis results can be obtained continuously.

  An embodiment of the present invention will be described. FIG. 1 is an overall configuration diagram of a multi-item chemical analyzer. In FIG. 1, a large number of sample containers 1 containing samples are arranged on a sample transport disk 2. The suction / discharge nozzle of the sample dispensing mechanism 5 is connected to the sample syringe pump 7. The operations of the pump 7 and the dispensing mechanism 5 are controlled by the microcomputer 3 that controls the operation of each mechanism unit and calculates measurement data through the interface 4. A large number of reaction vessels 6 are arranged on a reaction table 17 provided to be rotatable with respect to the reaction bath 9 to form a reaction line. A constant temperature liquid maintained at 37 degrees Celsius is supplied from the constant temperature liquid supply unit 10 to the reaction bath 9. The multi-wavelength photometer includes a light source 14 and a multi-wavelength spectrometer 15, and the reaction table 17 is rotationally transferred so that the light beam from the light source 14 crosses the row of reaction vessels 6. The used reaction vessel 6 is cleaned by the cleaning mechanism 19 and is reused. The stirring mechanism 13 mixes the sample added to the reaction vessel 6 and the reagent solution corresponding to the analysis item. A measurement signal based on the reaction solution obtained by the multi-wavelength spectrometer 15 is converted from an analog signal to a digital signal by the A / D converter 16 and input to the microcomputer 3.

  Various reagent bottles 12 corresponding to each analysis item are installed along the circumference on the reagent disk 26A for the first reagent and the reagent disk 26B for the second reagent. That is, the disks 26A and 26B are reagent bottle storage portions that can be selectively rotated. A barcode reader 23A is disposed near the disk 26A, and a barcode reader 23B is disposed near the disk 26B. The reagent dispenser includes reagent dispensing pipettors 8A and 8B and a reagent syringe pump 11. These pipettors 8A and 8B suck and hold a predetermined amount of the reagent liquid in the reagent bottle 12 stopped at the suction position in the suction and discharge nozzles, rotate these suction and discharge nozzles onto the reaction container row, and stop at the reagent receiving position. The retained reagent solution is discharged into the reaction vessel 6 that is being operated. The reagent solution dispensed at this time is of a type corresponding to the analysis item assigned to each reaction container.

  As shown in FIG. 2, each reagent bottle 12 has a reagent barcode label 22 with a barcode printed on its outer wall. The information displayed as the bar code indicates, for example, a reagent bottle code unique to each bottle consisting of a sequence number, the size of the bottle, the expiration date of the reagent solution, and whether the reagent is the first reagent, the second reagent or the third reagent. The reagent dispensing order, the maximum number of times that the reagent solution can be analyzed, the reagent dispensing amount indicating the amount of dispensing used once, the production lot number, and the like. Reagent information read from each reagent bottle 12 by the barcode readers 23A and 23B is stored in the memory area corresponding to the storage unit 25 or the microcomputer 3, respectively. As the reagent bottle 12 is stored in the reagent disks 26A and 26B, the reagent information is read by the barcode readers 23A and 23B. At this time, the rotation angle detectors provided on the reagent disks respectively A signal indicating the set position of the reagent bottle is output and input to the microcomputer 3 via the interface 4. The reagent information, the bottle set position, and the analysis item are stored in association with each other.

  The operator can input various information using the screen of the CRT 18 and the keyboard 21. The measurement result of the analysis item can be displayed on the printer 27 and the CRT 18. Information on the floppy disk 24 (floppy is a registered trademark) is read by the reading device and stored in the storage unit 25 or a corresponding memory area of the microcomputer 3. The information stored in the floppy disk 24 is, for example, the following. That is, an analysis item code displayed in five digits, a parameter commonly used for the analysis item, a parameter stored separately for each reagent bottle, and the like. Among them, the parameters commonly used in the analysis items are the wavelength used in the photometer, the sample amount, the calibration method, the standard solution concentration, the number of standard solutions, the check limit value for analysis abnormality, and the like. The parameters for each reagent bottle include reagent type, reagent dispensing order, reagent bottle code, reagent liquid volume, reagent dispensing volume, maximum number of analyzable times, reagent manufacturing date, and the like.

In addition to the information read from the floppy disk 24, the storage unit 25 reads the operating conditions of each mechanism unit of the analyzer, the analysis parameters of each analysis item, the determination logic for managing the bottle of each reagent, and the reagent bottle. The maximum possible number of analyzes, analysis results, etc. are stored. The reagent information is provided by a floppy disk provided by the manufacturer when the reagent bottle is delivered.
When reagent information is not prepared by the floppy disk, the operator can input information described on the visual confirmation sheet attached to the reagent bottle into the analyzer using the screen and the keyboard 21.

  As shown in FIG. 3, a specimen barcode label 50 having a barcode printed on its outer wall is attached to the specimen container 1. The information displayed as the barcode is, for example, a specimen identification number that uniquely determines the specimen. This number is read by the barcode reader 28, and by detecting the angle of the sample transport disk 2, the correspondence between the sample position and the sample identification number is recognized. On the other hand, since the analysis item corresponding to the sample identification number is input and stored in advance by the keyboard 21 and the CRT 18, the sample position, the sample identification number, and the analysis item are eventually stored in association with each other when the previous barcode is read. Further, it is generally possible to identify whether the sample is a standard sample, a control sample, or a general sample by the higher number of the sample identification number.

  Analysis of the entire automatic analyzer is performed in the order of data processing such as sampling, reagent dispensing, stirring, photometry, reaction vessel cleaning, concentration conversion, and the like as follows. A plurality of sample containers 1 containing samples are installed on a sample disk 2. The sample disk 2 is controlled by the computer 3 via the interface 4. Further, the specimen disk 2 causes the barcode 50 on the outer wall of the specimen container 1 to be read by the barcode reader 28 and associates the specimen with the analysis item. Thereafter, the sample is rotated under the probe of the sample dispensing mechanism 5 in accordance with the order of the sample to be analyzed, and the sample in the predetermined sample container 1 is reacted by the operation of the sample pump 7 connected to the sample dispensing mechanism 5. 6 is dispensed into a predetermined amount. The reaction container 6 into which the specimen has been dispensed moves in the reaction bath 9 to the first reagent addition position. A predetermined amount of reagent sucked from the reagent container 12 by the operation of the reagent pump 11 connected to the suction / discharge nozzle of the reagent dispensing pipettor 8 is added to the moved reaction container 6. The reaction vessel 6 after the addition of the first reagent moves to the position of the stirring mechanism 13 and the first stirring is performed. When up to the fourth reagent is set in the reagent disks 26A and 26B, such addition and stirring of the reagent is performed for the first to fourth reagents.

  The reaction vessel 6 in which the contents are agitated passes the light beam emitted from the light source, and the absorbance at this time is detected by the multi-wavelength spectrometer 15. The detected absorbance signal enters the computer 3 via the interface 4 via the A / D converter 16 and is converted into the concentration of the specimen. The density-converted data is printed out from the printer 27 via the interface 4 and displayed on the screen of the CRT 18. After completion of photometry, the reaction vessel 6 moves to the position of the cleaning mechanism 19 and is discharged with a cleaning liquid after being discharged by the vessel cleaning pump and used for the next analysis.

  One embodiment of the present invention is configured by connecting one or more of the analysis apparatuses described above to a determination support center through a communication path. FIG. 4 is a system block diagram of an embodiment of the present invention.

  In FIG. 4, the analysis apparatus 101 </ b> A is connected to the communication unit 102 in the determination support center 100 via the communication path 103. Similarly, a plurality of analyzers 101B and 101C are connected. The operation of the analyzer will be described using functional blocks in the analyzer 101A. When the reagent bottle is installed in the analyzer, the reagent bottle code is recognized by the reagent barcode reader. The bottle code is sent to the determination support center by the communication unit 104 for the purpose of requesting the determination support information. The request may use a code for specifying the reagent solution instead of the reagent bottle recognition code. Whichever code is used, the purpose is to request determination support information as a characteristic of the reagent solution. In the determination support center, analysis result data sent in the past by a large number of analyzers (101A, 101B, 101C in this embodiment) is stored in the storage unit 151. In response to a request from the analyzer, the determination support center uses the past analysis result data to calculate the average value and standard deviation of various analysis result data corresponding to the reagent solution by the statistical unit 150. The calculation target is the factor value of the standard sample, the concentration value of the control sample, and the absorbance at a specific time in the reaction process. Further, a predetermined number of absorbance series of all reaction steps are arbitrarily extracted. Further, correctness determination and text (non-numeric information) commented by the laboratory technician when the reagent solution has been used in the past are also extracted. The calculated average value / standard deviation and the extracted information described above are sent back to the previously requested analyzer 101A as determination support information. The analysis apparatus 101A stores these in a factor memory 108, a QC (Quality Control) value memory 109, a reaction curve memory 107, and a comment memory 111, respectively.

  When the analysis is started by the analyzer, the sample and the reagent in the specimen container 1 are mixed in the reaction container 6 as described above, and the reaction proceeds. The absorbance signal output from the A / D converter 16 is generally the specimen. In the case of a sample or a control sample, it is converted into a concentration value by the analysis result calculation 106. In the case of a standard sample, the analysis result calculation 106 converts it into a factor value corresponding to the slope of the calibration curve. Next, the determination unit 115 determines the average value and standard deviation of the factor values in the factor memory 108 when the sample is a standard sample, and the average value of the concentration values in the QC value memory 109 when the sample is a control sample. In the case of a general specimen, the average value and standard deviation of the absorbance at the time of the specific reaction step in the reaction curve memory 107 are acquired in the case of a general sample. Using the acquired average value and standard deviation, and the determined value (converted concentration value or absorbance) in the analysis result calculation 106, the value obtained by dividing the difference between the determined value and the average value by the standard deviation is If the corresponding threshold value in the threshold memory 110 is exceeded, a warning is generated. Here, with respect to the information in the threshold memory 110, the threshold is set in advance for various determination values using the keyboard 21 and the CRT 18.

  The generated warning is reported on a display on the CRT 18 or a buzzer for calling attention. A warning is printed as incidental information of the analysis result printed on the printer 27. Further, a comment when the reagent has been used in the past in the comment memory 111 is displayed to assist the operator's determination. In the comments, the past experience that could not be determined to be good and the reasons thereof are written in text, so the analysis results can be determined from various and objective viewpoints.

  With this support, the analyst will review the results and resolve the problem. If it is desired to leave the problem-solving items for use in later determination support, a comment regarding problem-solving is input using the keyboard 21. The determination value in the analysis result calculation 106 is stored in the storage unit 151 via the communication unit 104, the communication path 103, and the communication unit 102 together with any comment, and used for subsequent determination support.

  When a standard sample or a control sample is provided from a reagent manufacturer, a specific sample identification number is assigned to the sample, and is clearly distinguished from the sample identification numbers of other general samples. When such a sample identification number is read by the sample barcode reader 28, the determination unit 115 sends the sample identification number of the specific sample and the reagent code to be used together to the determination support center, and asks for the determination support information query. Matching is done. In the determination support center, only the value when the specific sample is used is extracted from among the factor values of the reagent, the average value / standard deviation is calculated, and this is sent to the analyzer. This makes it possible to perform determination support that takes into account the characteristics of the specific specimen in addition to the characteristics of the reagent.

  The determination support center is also connected to reagent providers 160A and 160B via a communication path. The reagent provider sets the reaction process absorbance series of the reagent to be provided and the reference average value / standard deviation of the standard sample / control sample to be provided as a sample via a communication path. These set data can be used as determination support information in the same manner as described above depending on the selection of the laboratory. In addition, comments as a reagent provider regarding a specific reaction can be similarly stored in the storage unit 151 of the determination support center and used as determination support information. In addition, the laboratory technician sends data and questions that are difficult to make judgments to the Judgment Support Center, and the reagent provider receives this question, writes the answers / advice as comments and sends them to the Judgment Support Center. The analysis device of the question source receives the data and the inspection engineer uses it for the determination of the inspection result. The destination of the question is not limited to the reagent provider, and if the destination of the question is an inspection engineer at another facility, the knowledge of the inspection engineer at the other facility can be obtained. The contents of these questions and answers are accumulated as comments in the accumulating unit 151 and can be used as later determination support information.

  The flow of information between the analysis apparatus 101 and the determination support center 100 will be described with reference to FIG. The analysis apparatus 101 transmits a determination support information request 503. The determination support center 100 that has received the information returns the determination support information 504 that is information for supporting the evaluation of the analysis result. Further, the analysis apparatus sends the analysis result data 505 to the determination support center 100 after the analysis is completed. The analysis result data 505 includes some or all of the analysis result, the evaluation result of the analysis result, the name of the inspection engineer, and the facility name of the inspection facility, and is converted into determination support information by the determination support center. The In addition, in order to search a part or all of the analysis result data in the accumulation unit of the determination support center, the analysis apparatus transmits an evaluation result search request 506 to the determination support center. Performs a search and returns the search result 507 to the analyzer.

  FIG. 6 shows the data structure of the storage unit 151 managed by the determination support center 100. The storage unit stores analysis result data transmitted from the analysis apparatus 101 for each apparatus ID that is an identification ID of the analysis apparatus 101. The management device number 601 indicates the number of analysis devices 101 managed by the determination support center 100. This portion 601 is called a header portion.

  The device ID 602, the device type 603, the PWD 604, and the number of data 605 indicate the ID for uniquely identifying the device, the model of the analyzer, the password, and the number of analysis performance data managed. As an ID that uniquely identifies a device, a device-specific number that can be read by the microcomputer of the device and assigned for each manufacturing is used, but the address is uniquely determined when the analyzer is connected to the network. The address can also be used as a device ID. The password is a character string that can be known only to the other party, the analysis device and the decision support center that should be properly connected. When the decision support center and the analysis device are connected, the passwords are collated on the communication path. The communication connection is established only when they match. If they do not match, the communication is cut off because the connection is to the wrong analyzer or judgment support center. This prevents the risk of collecting incorrect analyzer information and intentional unauthorized connection.

  In addition, the PWD 604 can include an encryption key (public key system) for authenticating a person who transmits information using the analysis apparatus or an operator in the determination support center. In other words, in order to prove that the sender's transmission content is indeed the sender, the hash value (using a method such as MD5) of the transmission contents is encrypted with encryption using a secret key that only the sender can know. The received certificate is attached to the transmission contents, and the receiving side does not send the sender's own transmission until the value obtained by decrypting the previous certificate with the sender's public key matches the hash value of the transmission contents. I can confirm that there is. With this encryption key, both the analysis device side and the decision support center side can be authenticated, so that legitimate information can be collected while steadily confirming the mission and responsibility of being used as decision support information in a wide area. Such an authentication system can also be applied to communication between a supplier and a determination support center, which will be described later. In addition, the transmission of erroneous analysis result data due to errors can be fulfilled by requesting the deletion to the decision support center when the errors become clear.

  A data area composed of the device ID 602, the device type 603, the PWD 604, and the data number 605 is referred to as a subheader portion.

  The data structure shown in FIG. 6 is mainly composed of three layers: a header part, a subheader part, and analysis result data. That is, a plurality of the subheader portions exist below the header portion, and a plurality of pieces of analysis result data exist in each of the subheader portions.

  Since the analysis result data has different contents depending on the type, an inspection ID 606 is provided at the top as an ID for identifying the type. By referring to the test ID 606, it is possible to identify whether the analysis result data is data related to a standard sample, data related to a QC sample, or data related to a general sample.

  The contents of the analysis result data will be described. The date / time 607 is the date / time when the sample was analyzed. The sample ID 608 is an identifier for uniquely identifying each sample for each standard sample, QC sample, or general sample. The reagent ID 609 is an identifier for uniquely identifying the reagent solution within the reagent provider. When a plurality of reagent solutions are used for one analysis item, a plurality of identifiers are entered. The reagent provider ID 610 is an identifier for uniquely identifying a reagent provider. An item name 611 indicates the type of the analyzed item. The measurement value 612 contains the measurement result, and in the case of a standard sample, it is a factor which is a calibration curve parameter, and in other cases it is a concentration value. The data alarm 613 is information indicating a warning (for example, sample shortage) detected by the analyzer during analysis of the specimen. The correctness determination 614 is a determination result of the reliability of the analysis result. It is judged whether there is no abnormality in the reliability of the analysis result, there is an abnormality, or there is no understanding. The engineer name 615 and the facility name 616 are the name of the laboratory engineer who inputs the determination 614 or the comment 617 of the reliability of the analysis result based on the evaluation result of the analysis result and the facility name of the facility where the analysis was performed. The comment 617 is an analysis result, determination, a determination reason sentence, an annotation sentence, or the like for the absorbance data. Absorbance data 618 is absorbance series data in one reaction step. Although not clearly shown in FIG. 6, if the test ID is general, the specimen type (serum, urine, etc.) and the patient's individual attribute information (gender, age, presence / absence of smoking, etc.) should be added. You can also.

  When the sample is a standard sample, the determination support information request 503 includes a test type 602, a reagent ID 609, a reagent provider ID 610, a standard sample ID 608, and an item name 611. The determination support information 504 includes an average value, a standard deviation, and the like. Consists of the latest three absorbance data. The average value and the standard deviation are measured values obtained by calculating, as a statistical population, an analysis result data group in which the reagent ID 609, the reagent supplier ID 610, the standard sample ID 608, and the item name 611 match in the analysis result data of the standard sample. The average value of 612 and the standard deviation. However, in the calculation of the average value and the standard deviation, the analysis result data to be searched is data for which the correctness determination 614 is “no abnormality”.

  When the sample is a control sample, the determination support information request 503 includes a test type 602, a reagent ID 609, a reagent provider ID 610, a QC sample ID 608, and an item name 611. The determination support information 504 includes an average value, a standard deviation, Consists of the latest three absorbance data. The average value and the standard deviation are obtained by the same method as that for the standard specimen.

  When the sample is a general sample, the determination support information request 503 includes a test type 602, a reagent ID 609, a reagent provider ID 610, an item name 611, a concentration range, and an index in the absorbance series indicating the absorbance value used for the determination. The determination support information 504 includes an average value, a standard deviation, and the latest three absorbance data. The average value and the standard deviation are an analysis result data group in which the reagent ID 609, the reagent provider ID 610, and the item name 611 match in the analysis result data of the general sample, and the measurement value 612 falls within the concentration range. The statistical population includes the average value and standard deviation of the absorbance at the location specified by the index in the data series in the absorbance data 618. However, in the calculation of the average value and the standard deviation, the analysis result data to be searched is data for which the correctness determination 614 is “no abnormality”.

  In the retrieval of the evaluation result, the reagent ID 609, the reagent supplier ID 610, the QC sample ID 619, the technician name 615, and the analysis period are specified in the evaluation result retrieval request 506, and the search result 507 is specified in the designated period. Measured values, absorbance data, and comments on the results are received. In addition, the examination result, the reagent ID, and the reagent provider ID are designated in the evaluation result search request 506, and further, the period during which the analysis is performed and a part or all of the patient attributes (gender, age, smoking presence, etc.) are designated, As the search result 507, a measurement value, absorbance data, and a comment on the result may be acquired that specify a specific gender, age, and smoking status in a specified period. Information relating to patient attributes is specified by the determination unit 115 of the analyzer by reading information relating to the correspondence between sample IDs and individual attributes from a predetermined memory and specifying them in the evaluation result search request 506.

  FIG. 8 is a business flow diagram of an embodiment of the present invention. Before starting the analysis, the operator of the analyzer performs analysis parameter setting (801), threshold setting (802), and statistical test condition setting (803) as preparations for effective operation of the determination support system. In the analysis parameter setting (801), information from the floppy disk 24 is read, and various parameters are taken in before the analysis operation by the analyzer is started. In the threshold value setting (802), a threshold value that is an upper limit index of statistical bias is set for each reagent, for each standard sample and for each control sample. In the determination condition setting (803), a condition for narrowing determination support information requested to the determination support center is set. For example, use the statistical value (average value / standard deviation) of the specific standard sample for the standard sample, use the statistical value of the specific control sample for the control sample, and the absorbance of the analysis using the specific reagent during the reaction process , Using the statistical value of the absorbance at a specific point in time, and using the statistical value calculated from the data of only the specific facility or group of information as the information used for determination support, the data determined by a specific laboratory technician Use the statistical value calculated from only.

  Next, the operator installs the reagent bottle in the analyzer and reads the barcode into the apparatus (804). That is, the barcode of the reagent bottle 12 set on the reagent disks 26A and 26B is read by the barcode reader 23A. Thus, the analyzer that has recognized the reagent bottle code requests the determination support center for the determination support information, and stores the determination support information returned from the determination support center (805). If the returned determination support information is information related to the standard sample, it is stored in the factor memory, if it is information related to the QC sample, it is stored in the QC memory, and if it is information related to the general sample, it is stored in the reaction curve memory.

  After making the above preparations, the operator instructs the analyzer to start analysis. When the analyzer is activated and analysis is performed (806), the analysis result is calculated from the sample for which the reaction has been completed as needed (807). If the sample type is a standard sample, the average value / standard deviation of the factor values of the standard sample of the determination support information is (810), and if the sample type is a control sample, the concentration average value / standard deviation of the control sample of the determination support information (809), if it is a general sample, the determination is performed using the average value and standard deviation of the absorbance at a specific point in the reaction process of the determination support information (808). As a determination method, the value obtained by dividing the difference between the determination value obtained in 807 and the average value by the standard deviation is compared with the threshold value input in step 802. If it exceeds the threshold, a warning is generated because the deviation from the average value is outside the allowable range. This is repeated for all specimens (811).

  When all the analyzes are completed, the person in charge of the examination looks at the review screen to determine whether the analysis results of all the samples are correct (812). In step 812, when the analysis result is the analysis result of the QC sample, the QC value, the average value, and the standard deviation are read from the QC value memory, and the reaction absorbance curve data is read from the reaction curve memory and displayed on the display unit (112). indicate. When the sample is a standard sample, the factor, average value, and standard deviation are read from the factor memory (108), and the reaction absorbance curve data is read from the reaction curve memory and displayed on the display unit (112). When the sample is a general sample, the reaction absorbance curve data is read from the reaction curve memory and displayed on the display unit (112). In this embodiment, the reaction absorbance curve is displayed by superimposing the reaction absorbance curve measured by the sample analysis and the reaction absorbance curve received from the determination support center. In addition, the color of each graph is changed for display. On the review screen, the result is displayed together with the determination support information and the determination, and the final determination and the comment are input (813). If the sample is a standard sample, the absolute value of the difference between the factor value and the average value is positive if the absolute value is smaller than the standard deviation × threshold value, and is not determined if it is large. If the sample is a QC sample, the absolute value of the difference between the QC value and the average value is positive if the absolute value is smaller than the standard deviation × threshold value, and is not determined if it is large. In addition, the graph of the reaction absorbance curve displayed on the display unit is also used for correctness determination. After the correct / incorrect determination, the inspection engineer inputs the determination of the reliability of the analysis result, the comment, the name, and the facility name to the analyzer through the user interface. The analysis result and the evaluation result input by the laboratory technician are stored in a predetermined memory. In particular, when determining NO, the determination result and information on the evaluation result can be displayed on the display unit 112 by an input to the keyboard 21 or the information on the determination result and the evaluation result can be printed using the printer 27. Further, when the determination is NO, the subsequent analysis is stopped by stopping the dispensing of the current reagent. An operator who is informed of the stop by the warning starts a specific cause investigation work. When it is desired to use the input data for subsequent determination support, analysis result data 504 is obtained by adding the device ID and device type to the analysis result and evaluation result of each specimen, the name of the laboratory technician who performed the analysis, and the name of the facility. Is transmitted to the decision support center (814).

  The processing flow on the determination support center side will be described with reference to FIG. FIG. 9A is a flow of determination support information transmission. The determination support center receives a determination support information request from the analyzer (901). This request includes a reagent bottle code. Since the information provided as the determination support information is in units of reagent solution, the center calculates the reagent solution code from the bottle code, and searches and calculates the determination support information based on this (902). Further, when the request includes a condition for narrowing down the determination support information (for example, it is calculated only from data of a specific facility), it is applied as a search condition. The calculated determination support information is sent to the requested analyzer (903).

  FIG. 9B is a processing flow of analysis result data sent from the analyzer. When the analysis result data is received from the analysis device (904), the determination support center calculates the ID of the transmission source analysis device from the source communication address, and stores the analysis result data in the storage unit 151 in units of this analysis device ID (905). ). By storing information in units of device IDs in this way, it is possible to easily grasp the status of devices in units of customers. For example, if the analyzer regularly reports the status (remaining amount, etc.) of the reagent in the apparatus to the determination support center, the information is stored in units of apparatus IDs, and the status of the reagent is determined in units of apparatuses (consumption prediction, etc.) ) Is also possible.

  FIG. 10 shows an example of the review screen. On the review screen, the determination value calculated in step 807 for each sample, its attribute, and determination support information corresponding to the value are displayed in the result display frame 1001. In the example of FIG. 10, the reagent used for the result of the standard sample, the sample, and the calculated factor value are displayed, and whether the threshold has been exceeded (not) or not (positive) is displayed. The In addition, an average value and a standard deviation value acquired from the determination support center are displayed as reference information. Furthermore, the sample curve groups of the past reaction processes acquired from the determination support center are displayed together with the curve of the absorbance change in the reaction process of the reaction. The reaction curve is drawn in red and the other curves are drawn in blue to clarify which is the reaction curve. The operator determines from this information whether the result is correct or abnormal, and marks the correct / incorrect determination input area 1002 with a check mark. If it is determined that there is an abnormality, a check mark for re-examination is further marked if inspection is necessary again. In addition, when it is determined that it can be used as determination support in future analysis regardless of whether it is abnormal or normal, the characteristic points and caution points of the current data are written in the comment column 1003. If necessary, the name of the person himself / herself (analyst in charge such as an inspection engineer) is input in the input area 1004, the facility name is input in the input area 1005, and the transmission button 1008 is pressed. Thus, the above data is transmitted to the determination support center and used as subsequent determination support information. When confirming the previous sample again, a “Previous” button 1007 is pressed, and when reviewing the next sample, a “Next” button 1006 is pressed. Here, information such as analysis results is sequentially displayed in the order of analysis, but can be displayed as a list for each order of analysis and type of specimen. In particular, by listing sample identifiers, sample types (standard samples, control samples, general samples, etc.), determination information, and determination support information, a list of problem trends can be obtained.

  FIG. 11 shows an evaluation result search screen. With this screen, the determination support information in the determination support center 100 can be searched and displayed. The search screen simultaneously displays a graph 1106 of a reaction absorbance curve of a control sample performed by a specific engineer during a specified period and a comment 1107 for the graph. The factor value may be displayed on this screen. Moreover, you may display the same information regarding a standard sample, a general sample, or an emergency sample. The reagent ID 1101, sample ID 1102, laboratory technician name 1103, examination period 1104, and item name 1110 are screens for entering search conditions, and the search 1105 is a button for requesting the start of search.

  According to the above-described embodiment, the determination support center collects analysis result data from a plurality of analysis devices, transmits the determination support information to the analysis device, and uses the determination support information to determine whether the analysis result is correct or not. Improve the reliability of the results. When determining NO, it is possible to prevent a problem in reliability. Furthermore, if the analyzer detects a warning during analysis, the analysis can be continued with the warning attached to the analysis result, so that the system can be prevented from stopping frequently, and the analysis result can be obtained by referring to the warning after the analysis. Can be made more reliable. In the search screen shown in FIG. 11, the analysis result can be evaluated with reference to the comments of a highly skilled inspection engineer, so that the determination of the analysis result can be made more reliable.

  Another embodiment of the present invention will be described with reference to FIG. FIG. 12 shows another embodiment of the present invention using a communication network. In the embodiment, the reliability of the analysis result is improved by connecting the analysis apparatus and the determination support center via a network, and sharing the information between the analysis apparatus and the determination support center. Then, a server of a reagent provider (hereinafter referred to as a reagent provider server) and a server of an apparatus provider (hereinafter referred to as an apparatus provider server) are connected to the network, and the automatic analysis is performed via a determination support server. The reliability of the analysis result is further improved by sharing information between the reagent provider server and the apparatus provider server. In the example shown in FIG. 12, since there are a plurality of device providers, the accumulation unit of the determination support center analyzes the data structure in which the device provider ID is added to the data structure of each analysis result data shown in FIG. Manage as data. The determination support center is realized as a determination support center server 1201 and connected to the network 1201. The analysis apparatus 101 may be directly connected to the network 1201 by the modem 1205 or may be connected to the hospital server 1203 via the local network 1211. In the one embodiment, the analysis support apparatus receives the determination support information by transmitting a determination support information request. Further, the analysis apparatus transmits analysis result data from the determination support center to the determination support center. Further, the analysis apparatus transmits an evaluation result search request to the determination support server 1201 and receives the search result. The transmission / reception of information with the determination support center shown here is not limited to the analysis apparatus in the embodiment different from the one embodiment, and can be realized by the registration / display computer 1208. Since the registration / display computer 1208 includes an input unit such as a keyboard and a communication unit, it accepts analysis results and evaluation results via the input unit, and uses the communication unit to support determination of the analysis results and the evaluation results. It transmits to the center server 1201, receives a response if necessary, and stores the received information in a predetermined memory. Here, the information received by the registration / display computer 1208 via the input unit and the information transmitted to the determination support center server 1201 may be only one of the analysis result and the evaluation result. Also, information such as analysis results and evaluation results is shared with the analyzer via the network, and the shared information is sent to the decision support center, and when a response is received, the contents are shared. You may make it reflect. The reagent provider side is also realized as a server and connected to the network 1210. The network 1210 can be realized by an in-facility network or a wide area network. In FIG. 12, since the apparatus provider is also connected to the network by the server 1207, it is possible to perform determination support as viewed from the apparatus provider.

  FIG. 13 is an information relation diagram showing the flow of information in a system including a device provider. As described above, the analysis apparatus 101 transmits a determination support information request 503 to the determination support center, and receives the determination support information 504 as a reply. Further, the analysis apparatus provides analysis result data 505 to the determination support center as primitive information of the determination support information. Further, the analysis apparatus 101 can search the determination support information by sending an evaluation result search request 506 to the determination support center and having the search result 507 returned. The determination support center 100 separately manages the number of times of transmission of the determination support information 504 and the search result 507 and the number of times of reception of the analysis result data for each analysis device, and transmits the managed information to the corresponding analysis device. The analyzer that has received the information displays the received information on the display unit.

  The reagent provider 1302 transmits reagent characteristic information 1314, which is information related to reagent characteristics, to the determination support center. In the present embodiment, it is assumed that reagent provider information, reagent ID, and information on the reaction absorbance curve are attached to the reagent characteristic information and transmitted. The determination support center that has received the information stores the information in the storage unit 151 for each reagent provider ID and reagent ID. The information can be acquired from the analyzer using the reagent provider ID and the reagent ID as search keys. The analyzer can also display the information on the same screen as the analysis result of the sample. In addition, the reagent provider 1302 transmits a reagent result information search request 1312 that is a request for searching for information related to reagent results to the determination support center, and receives a search result 1313 that is a response to the request. In this embodiment, the device provider ID, device type 603, reagent ID, reagent provider ID, and standard sample ID are specified in the reagent performance information search request, and the average value regarding the factor value for each reagent provider is obtained as a search result. A standard deviation shall be received. The determination support center 100 separately manages the number of transmissions of the search result 1313 and the number of receptions of the reagent characteristic information for each reagent provider server, and transmits the managed information to the corresponding reagent provider server. The reagent provider server that has received the information displays the received information on the display unit.

  The device provider 1304 transmits device characteristic information 1311 that is information related to the device characteristics to the determination support center. In the present embodiment, as device characteristic information, device provider ID, device type, and device-specific temperature stability information for each analysis item are attached and transmitted. The determination support center that has received the information stores the information in the storage unit 151 for each device provider ID and device type. The information can be acquired from the analysis device using the device provider ID and device type as a search key. The analyzer can also display the information on the same screen as the analysis result of the sample. Also, the device provider 1304 transmits a device performance information search request 1309 that is a request for searching for information related to the device performance to the determination support center, and receives a search result 1310 that is a response thereto. In this embodiment, the number of analyzer types to be investigated is specified in the apparatus result information search request for the number of analysis apparatus types to be investigated for the combination of the apparatus provider ID, apparatus ID, reagent ID, reagent provider ID, and standard sample ID, and each apparatus type is searched The mean and standard deviation for each factor value shall be received. In addition, a test ID, a reagent ID, a reagent provider ID, a device provider ID, and a device ID are specified in the evaluation result search request 1309, and the results and evaluations that have been determined not to be the specified analysis and reagent as search results 1310. Can be acquired. The determination support center 100 separately manages the number of transmissions of the search result 1313 and the number of receptions of the device characteristic information for each device provider server, and transmits the managed information to the corresponding device provider server. The device provider server that has received the information displays the received information on the display unit.

  FIG. 7 shows a processing flow of the determination support center. In this processing flow, the type of the message received from the analyzer 101, the reagent provider 1302, or the apparatus provider 1304 is determined, and processing for each type is performed.

  In the determination support center, a message is received from the analysis device or the vendor via the network (1401). Since an ID indicating the type is attached to the message, the process is distributed according to this ID (1402). If the message is analysis result data 505, reagent characteristic information 1314, or apparatus characteristic information 1311, the process proceeds to step 1403. If the determination support information request 503 is determined, the process proceeds to step 1404, and the evaluation result search request 1308 or the reagent result information search 1312. Or if it is apparatus performance information search 1309, it will change to Step 1405.

  In step 1403, the received information is stored in the storage unit 151. In step 1404, determination support information is calculated based on the specified ID or the like. In step 1405, the storage unit 151 is searched using the specified ID or the like as a key, and a response message corresponding to the received message is created. In step 1406, the response message is transmitted.

  According to another embodiment described above, since the analyzer can acquire information on the characteristics of the reagent set by the reagent provider in the determination support center, the reliability of determination of the analysis result can be improved. Since the reagent provider 1302 can compare the information related to the analysis of the reagent provided by the reagent provider with the information related to the analysis of the reagent provided by the other reagent provider, the reagent provider considers improvement of the reagent based on the comparison result. And so on.

  Further, since the analysis apparatus can acquire information on the characteristics of the apparatus set by the apparatus provider in the determination support center, it is possible to improve the reliability of determination of the analysis result. Since the device provider 1304 can acquire the results of analysis for each device type of the company, the device provider 1304 can perform improvement studies on the device. Also, to provide a system that collects evaluation comments detected in a specific device when a specific reagent is used, makes it possible to study improvement and know-how on the device, and disseminate it, and perform a highly reliable test. Can do.

  In the determination support server, the determination support server manages the amount of information acquired from the analyzer, the reagent provider server, and the apparatus provider server, and the amount of information provided to the analyzer, the reagent provider server, and the apparatus provider server. In addition, it is possible to perform cashing or charging according to the amount of information acquired and the amount provided. That is, when the information provider (analyzer, reagent provider server, and apparatus provider server) is charged for the amount of information (acquisition amount) enjoyed by the provider, the information is provided from the value of the acquisition amount. By charging the portion where the value of the amount is reduced, provision and accumulation of useful information can be promoted. Further, by separately managing the acquisition amount and the provision amount, it is possible to provide a service such as not charging for the acquisition amount when a certain provision amount is satisfied. This also helps promote the provision and accumulation of useful information. Since the information regarding the acquired amount and the provided amount is displayed on the display unit of the analyzer, the reagent provider server, and the device provider, it is possible to determine whether to provide or acquire information with reference to the displayed information.

The block diagram of the multi-item chemical analyzer of one Example. The example of the reagent information of a reagent bottle outer wall. An example of sample information on the outer wall of the sample container. The system block diagram of one Example. The information related figure between an analyzer and a judgment support center. The data structure figure of the storage part which a judgment support center manages. The processing flow figure of a judgment support center. Business flow diagram on the analyzer side. The operation | movement flowchart by the side of a judgment support center. An example of a review screen. An example of an evaluation result search screen. The system block diagram of one Example using a communication network. The information related figure of one Example including an apparatus provider.

Explanation of symbols

  DESCRIPTION OF SYMBOLS 3 ... Microcomputer, 6 ... Reaction container, 8A, 8B ... Reagent dispensing pipetter, 12 ... Reagent bottle, 17 ... Reaction table, 18 ... CRT, 21 ... Keyboard, 23A, 23B, 28 ... Bar code reader, 24 ... Floppy disk, 26A, 26B ... reagent disk, 27 ... printer, 100 ... determination support center, 101A, 101B, 101C ... analyzer, 115 ... determination unit, 160A, 160B ... reagent provider.

Claims (15)

A method of managing at least one analysis device connected to a network and a server for managing information of the analysis device, and managing analysis results by the analysis device;
The analyzer performs analysis by dispensing a reagent solution corresponding to an analysis item from a plurality of reagent solution tanks into a reaction container for analysis of a plurality of analysis items, and the analysis result is transmitted through the network. To the server,
Storing the analysis result in a storage unit in the server, obtaining at least one of an average value and a standard deviation of the analysis result based on the plurality of stored analysis results, and transmitting the obtained result to the analysis device Analysis result management method characterized by   2. The analysis result management method according to claim 1, wherein the analysis result by the analysis device is determined based on at least one of an average value and a standard deviation of the analysis results transmitted from the server, and the analysis result is determined to be abnormal. An analysis result management method, characterized in that if it is, a warning output to that effect or reagent dispensing processing of the analyzer is disabled.   2. The analysis result management method according to claim 1, wherein for information stored in a storage unit in the server, information including at least a device type and an analysis date is used as a search key, and information corresponding to the specified search key is set as the search key. An analysis result management method comprising: transmitting to the analysis device via a network.   2. The analysis result management method according to claim 1, wherein the analysis device receives an evaluation result by an inspection engineer for an analysis result by the analysis device, stores the evaluation result in a storage unit, and evaluates the analysis result and the analysis result via the network. An analysis result management method comprising: transmitting a result to a server, and storing the received analysis result and an evaluation result for the analysis result in a storage unit in the server in association with an analysis device.   5. The analysis result management method according to claim 4, wherein when the server stores an evaluation result with respect to the analysis result, at least a first identifier for identifying a laboratory technician who has input the evaluation result and the analysis are performed. One of the second identifiers for specifying the facility where the analyzer is installed is stored together with the evaluation result.   6. The analysis result management method according to claim 5, wherein when information specifying the first or second identifier is transmitted from the analysis device side to the server via the network, it corresponds to the specified identifier. An analysis result management method, wherein the evaluation result and the corresponding analysis result are read from a storage unit in a server and transmitted to the analysis device via a network.   6. The analysis result management method according to claim 5, wherein when the inquiry information for the analysis result is transmitted from the one analysis apparatus together with the first or second identifier to the server via the network, the server corresponds to the identifier. An analysis result management method comprising: transferring the inquiry information to an analyzing apparatus that transmits the response to the inquiry from the analyzing apparatus corresponding to the identifier to the one analyzing apparatus.   2. The analysis result management method according to claim 1, wherein the server stores information on reaction absorbance as an analysis result by the analyzer in the storage unit, and distributes information on the reaction absorbance to each analyzer. An analysis result management method, wherein the received information on the reaction absorbance and the information on the reaction absorbance of the analyzed specimen are displayed on the same graph.   9. The analysis result management method according to claim 8, wherein each analysis device displays the received information on the reaction absorbance and the information on the reaction absorbance of the analyzed sample on different graphs on the same graph. Management method.   2. The analysis result management method according to claim 1, wherein when the sample is a general patient sample, the server collects and stores patient attribute information from the analyzer via the network together with the sample analysis result. An analysis result management method characterized by:   11. The analysis result management method according to claim 10, wherein the attribute information is encrypted and stored in the server, and only the attribute information transmission source can decrypt and read the attribute information. Analysis result management method.   An analysis result management system in which at least one analysis device that analyzes a sample using a reagent solution corresponding to an analysis item and a server that manages information on the analysis device are connected to each other via a network, The server stores a result of analysis by the analyzer received via the network, and means for obtaining at least one of an average value and a standard deviation of the analysis results based on the plurality of stored analysis results And an analysis result management system comprising means for transmitting the obtained result to the analysis device.   13. The analysis result management system according to claim 12, wherein the analysis device determines the quality of the analysis result by the analysis device based on at least one of an average value and a standard deviation of the analysis results transmitted from the server, and performs analysis. An analysis result management method comprising a control means for disabling a warning output or reagent dispensing process of the analyzer when the result is determined to be abnormal.   13. The analysis result management method according to claim 12, wherein the server stores an evaluation result by an inspection engineer for an analysis result by the analysis device transmitted from the analysis device in the storage unit together with the analysis result for each analysis device. The analysis result management method characterized by this.   15. The analysis result management system according to claim 14, wherein when the server stores an evaluation result for the analysis result, the server performs at least a first identifier for identifying a laboratory technician who has input the evaluation result and the analysis. One of the second identifiers for specifying the facility where the analyzer is installed is stored together with the evaluation result.

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