JP4612375B2 - Inspection apparatus and inspection method - Google Patents

Description

  The present invention relates to an inspection apparatus using a computer, and more particularly to confirmation of an inspection pretreatment.

  Conventionally, various types of inspections have been performed for the following purposes as quality control of chemicals and the like.

(1) Confirmation that the quality (titer, purity, etc.) of raw materials, materials and products (including intermediate products) conforms to the standards,
(2) Improving stability in each process by investigating quality bias and variation and providing feedback to the manufacturing process,
(3) Investigation of the cause of quality abnormalities,
(4) Investigation of product stability.

  Conventionally, in such inspection reports, a method of retroactively searching for the cause when there is an abnormality based on various test results has been adopted. That is, it was assumed that the test was properly performed including the equipment and reagents used in the test.

  Patent Document 1 discloses a sample inspection system that uses a computer to measure a sample.

JP 2003-66050 A

  However, with regard to the above test results, even if there is a problem with the equipment and reagents used for the test, the test result may be normal. That is, even when a certain test result is normal, it may happen that the abnormality is not detected due to the involvement of various factors as a result of using the reagent having the abnormality.

  An object of the present invention is to provide an inspection apparatus that solves the above problems and improves the reliability of inspection results. Specifically, it is an object of the present invention to provide an inspection apparatus capable of detecting in advance the possibility of causing an abnormality in an inspection result. More specifically, an object of the present invention is to provide an inspection device used for inspection and an inspection device capable of detecting an abnormality of a inspection reagent used for inspection.

  1) An inspection apparatus according to the present invention includes: 1) inspection device data storage means for storing inspection device expiration date determination data for determining the expiration date of the inspection device used for inspection; and 2) determining the expiration date of the inspection reagent used for inspection. Test reagent data storage means for storing test reagent expiration date determination data, 3) Test ID-specific correspondence data storage means for storing test ID-specific correspondence data in which a test device and a test reagent are associated with a test ID, 4) Input means for inputting inspection ID and inspection date, 5) Inspection equipment corresponding to the inspection ID from the corresponding data for each inspection ID stored in the corresponding data storing means for each inspection ID using the input inspection ID as a key And an instrument reagent determining means for determining a test reagent, and 6) the use of the test instrument and the test reagent determined by the instrument reagent determining means from the data storage means for each test instrument. Read out the test equipment deadline determination data for the test apparatus and the test reagent deadline determination data for the test reagent from the test reagent data storage means, and the input test date passes the instrument test deadline and the test reagent deadline. 7) a notification means for notifying the device inspection date, if the inspection date exceeds either the device inspection time limit or the test reagent time limit, or both. ing. Therefore, it is possible to notify the abnormality of equipment and reagents used for the test.

  2) An inspection method according to the present invention is an inspection method for inspecting whether an inspection device and an inspection reagent are appropriate before inspection using a computer, and A) a1) inspection ID in the storage unit of the computer Data related to the test reagents and test reagents associated with each other, a2) test equipment deadline determination data for determining the test deadline for each test equipment, a3) the expiration date of the test reagent used for each test The test reagent expiration date determination data to be determined is stored. B) When the test ID is input, the computer uses the test ID as a key, and the test reagent corresponding to the test ID and the test reagent A test reagent is determined, and C) using the test equipment time limit determination data and the test reagent time limit determination data, the given test date is the test equipment time limit or the test reagent time limit. Zureka or if you are passed doers both is to notify the same. Therefore, it is possible to notify the abnormality of equipment and reagents used for the test.

  3) A program according to the present invention is a program for causing a computer to function as an inspection device for inspecting whether or not an inspection device and an inspection reagent are appropriate before an inspection. A) The computer includes a1) an inspection ID. In contrast, device reagent correspondence data in which test devices and test reagents are associated, a2) test device time limit determination data for determining the test time limit for each test device, a3) determining the expiration date of the test reagent used for each test The test reagent expiration date determination data to be stored is stored. B) When the test ID is input by causing the computer to execute the following processing, the test ID is used as a key from the instrument reagent correspondence data. C) a test device and a test reagent corresponding to the above are determined, and C) a given test using the test device time limit determination data and the test reagent time limit determination data. But if you are passed doers either or both of the testing equipment date or test reagent expiration informs them. Therefore, it is possible to notify the abnormality of equipment and reagents used for the test.

  4) The program according to the present invention further includes, in the storage unit of the computer, allowable management data of reagent characteristic values determined for the test reagent to function as a reagent, and a measurement reagent measured for each test reagent Storing a characteristic value, and determining whether or not the measurement reagent characteristic value is within the allowable management data range for the determined test reagent, and the measurement reagent characteristic value is not within the allowable management data range In this case, this is notified to the operator by the notification means. Therefore, it can be notified whether or not the reagent used for the test has deteriorated.

  5) The program according to the present invention A) stores the following 1) to 3) in the storage unit of the computer, 1) standard products and quality control products used for the test for each of the test reagents, and 2) the permission As management data, in addition to the inspection reagent characteristic value tolerance management data, the standard product tolerance management data of the standard product used in the examination and the tolerance management data of the quality control article used in the examination, 3) the determined Measurement standard product characteristic value and measurement accuracy management product characteristic value measured with the test reagent using the test reagent, and B) Measurement standard product characteristic value and / or measurement accuracy management product characteristic value If the measurement standard product characteristic value and / or the measurement accuracy control product characteristic value is not within the allowable management data range, the operator determines whether the measurement standard characteristic value and / or measurement accuracy control characteristic value is within the allowable management data range. Let me know. Accordingly, it is possible to notify the abnormality of the measurement standard product characteristic value and / or the measurement accuracy control product characteristic value.

  6) The program according to the present invention stores tolerance management data of the specimen to be examined in the storage unit of the computer, and whether the measurement value for the specimen to be examined is within the range of the tolerance management data. If it is not within the allowable management data range, this is notified to the operator. Therefore, it is possible to notify the abnormality about the specimen to be examined.

  In the present specification, “prepared reagent” refers to a prepared reagent. In addition, as shown in the embodiment, “notification” includes notifying the operator on the screen, but also notifying the reliability of the inspection method to a third party on the screen or by printing it. .

  In addition, the “testing device” corresponds to the device used in the embodiment, and the “testing reagent” corresponds to the prepared reagent.

1. Outline and Description of Functional Blocks An embodiment of the present invention will be described with reference to the drawings. FIG. 1 shows a functional block diagram of an inspection apparatus 1 according to the present invention.

  The inspection apparatus 1 includes an inspection ID correspondence data storage unit 3, an inspection instrument data storage unit 5, an inspection reagent data storage unit 7, an input unit 8, an instrument reagent determination unit 9, an expiration date determination unit 11, and a notification unit 13. Yes.

  The inspection device data storage means 5 stores inspection device expiration date determination data for determining the expiration date of the inspection device used for the inspection. The test reagent data storage means 7 stores test reagent time limit determination data for determining the use time limit of the test reagent used for the test. The test ID correspondence data storage means 3 stores the test ID correspondence data in which the test equipment and the test reagent are associated with the test ID. The input means 8 inputs the inspection ID and the inspection date according to the operator's command. The instrument reagent determining means 9 determines the test instrument and the test reagent corresponding to the test ID from the test ID specific data stored in the test ID specific data storage means 3 using the input test ID as a key. The expiry date judging means 11 for the test equipment and test reagent determined by the equipment reagent determining means 9 from the test equipment-specific data storage means 5 to the test equipment time limit determination data for the used equipment and the test reagent data storage means 7 for the test. The test reagent deadline determination data for the reagent is read, and it is determined whether or not the input test date has passed the instrument test deadline and the test reagent deadline. The notification means 13 notifies when the inspection date exceeds either the inspection effective date, the preparation reagent effective date, or both.

2. Hardware Configuration of Inspection Device 1 A hardware configuration of the inspection device 1 shown in FIG. 1 will be described with reference to FIG. FIG. 2 is an example of a hardware configuration in which the inspection apparatus 1 is configured using a CPU.

  The inspection apparatus 1 includes a CPU 23, a memory 27, a hard disk 26, a CDD (CD-ROM drive) 25, an input device 28, a monitor 30, and a bus line 29.

  The CPU 23 controls each unit via the bus line 29 according to a program stored in the hard disk 26. In the present embodiment, Windows XP (trademark) manufactured by Microsoft Corporation is employed as the operating system 26o.

  The hard disk 26 includes a program storage unit 26s that stores programs to be described later, a master file storage unit 26m, and an inspection result storage unit 26k. This program is read from the CD-ROM 25a storing the program via the CDD 25 and installed in the hard disk 26. In addition to the CD-ROM, a program such as a flexible disk (FD) or an IC card may be installed on a hard disk from a computer-readable recording medium. Furthermore, it may be downloaded using a communication line.

  In the present embodiment, the program stored in the CD-ROM is indirectly executed by the computer by installing the program from the CD-ROM to the hard disk 26. However, the present invention is not limited to this, and the program stored in the CD-ROM may be directly executed from the CDD 25. Note that programs that can be executed by a computer are not only programs that can be directly executed by being installed as they are, but also programs that need to be converted into other forms (for example, those that have been compressed) In addition, those that can be executed in combination with other module parts are also included.

  The master file storage unit 26m stores a device / reagent configuration master, a reagent master, a device master, a reagent preparation master file, and a reference product master. Each master file will be described with reference to FIGS.

  The data structure of the instrument / reagent configuration master is shown in FIG. The device / reagent configuration master stores the reagents and devices to be used for the test (examination contents). In this case, the tag number of the used device, the used reagent code, the used reagent management number, etc. are stored.

  The data structure of the reagent master is shown in FIG. The reagent master stores, for each reagent, the name of the reagent, the upper and lower limit (allowable range of measurement) of the characteristic value, the alarm date, and the like. The alarm date is the number of days for displaying a warning alarm when a predetermined period before the expiration date as a reagent is reached.

  The data structure of the device master is shown in FIG. The device master stores the device name, usage classification, expiration date, and the like for each device.

  The data structure of the reagent preparation master is shown in FIG. The reagent preparation master stores the control number, reagent code, preparer, expiration date, alarm date, pH value (pH), electrical conductivity (EC), absorbance (OD), etc. Measurement results of reagent attributes and the like are stored. EC is an indicator of the ionic state of the solution (particularly related to the salt concentration). For example, in protein preparations, the same protein shows different properties in the solution due to the difference in ionic state. OD refers to the absorbance of a substance in solution. By measuring the absorbance, for example, the concentration of a specific protein can be known. That is, the OD is an indicator of the concentration of a specific protein solution in this case.

  The difference between the reagent preparation master and the reagent master will be described. The reagent master stores characteristics of general reagents and the like, and the reagent preparation master stores actual measurement values relating to the prepared reagent for the reagents stored in the reagent master.

  The data structure of the reference product master is shown in FIG. The reference product master stores data for determining whether the inspection result satisfies a predetermined standard.

  Thus, the master file storage unit 26m stores the master file used in the pre-inspection process and the master file used in the post-inspection process. Some of the master files are used in both pre-test processing and post-processing. Reference to each master file will be described later.

4). Flowchart Processing in the inspection apparatus 1 will be described with reference to FIG. The operator inputs an inspection ID and an inspection date for specifying an inspection to be performed from the input device 28. The inspection date may be automatically input using the date in the computer. In the following description, it is assumed that the test is executed on June 27, 2003 and the test “aluminum content test (AL)” is input as an inspection.

  When the test content is designated, the CPU 23 determines the test content (step S1 in FIG. 8). When the inspection content is determined, the CPU 23 makes a pre-measurement process determination (step S3). Details of the pre-measurement process determination will be described with reference to FIG.

  The CPU 23 refers to the device / reagent configuration master shown in FIG. 3 and determines the device and the preparation reagent to be used (step S11 in FIG. 9). In this case, since the test is the test “aluminum content test (AL)”, “HH1XI0261” and “HH1ZA0023” are specified as the equipment used, and the prepared reagents with the management numbers “20021218” and “20030501” are specified as the reagents used.

  Next, the CPU 23 determines whether the expiration date of the device or the alarm date has passed (step S13). Whether or not the expiration date of the device in use has been exceeded can be determined by referring to the expiration date stored in the device master. In this case, the expiration date of the used device “HH1XI0261” is “200306” in the device master (see FIG. 5). This means the end of June 2003. On the other hand, since the inspection date is June 27, 2003, the CPU 23 determines that the expiration date has not been exceeded. Also, since the expiration date of the used device “HH1ZA0023” is “200309” (end of September 2003), it is determined that the expiration date has not been exceeded. The alarm date may be determined by calculating the alarm date for each device used from the expiration date of the device master (see FIG. 5) and determining whether the alarm date has elapsed. In this embodiment, the alarm date is set as two months before the expiration date. Therefore, in this case, the alarm date of the used device “HH1XI0261” is the end of April 2003. Since the current date is June 27, 2003, the CPU 23 determines that the alarm date has passed for the used device “HH1XI0261”. Further, since the expiration date of the used device “HH1ZA0023” is September 30, 2003, the alarm date is July 30. Therefore, the CPU 23 determines that the alarm date has not elapsed for the used device “HH1ZA0023”. Eventually, in this case, the device used “HH1XI0261” is stored as having passed the alarm date (step S15).

  Note that when the expiration date has passed, the alarm date has naturally passed, so it is not necessary to determine the alarm date for devices that have passed the expiration date.

  Next, the CPU 23 determines whether or not the expiration date or alarm date of the prepared reagent has been exceeded (step S17 in FIG. 9). Specifically, the CPU 23 determines whether or not the expiration date or alarm date set in the reagent preparation master has been exceeded for the reagents with the management numbers “20021218” and “20030501” used as the preparation reagents. In this case, the expiration date for the reagent with the management number “20021218” is June 17, 2003, the alarm date is May 18, 2003, and the expiration date for the reagent with the management number “20030501” is May 14, 2003. The day and the alarm date are May 07, 2003. On the other hand, the inspection date is June 27, 2003. Therefore, the CPU 23 determines that any of the reagents has expired, and stores that the reagents with the management numbers “20021218” and “20030501” have all expired (step S19).

  Next, the CPU 23 determines whether or not the measurement result measured in advance for the prepared reagent is within the management range (step S21 in FIG. 9). This may be determined by determining whether the measurement result of the reagent preparation master (see FIG. 6) is within the range set in the reagent master (see FIG. 4). In this case, the dispensing reagent “20021218” has pH and EC of “5.61” and “3.83”, respectively. Since the dispensing reagent “20021218” has a reagent code of “HH1SAB”, referring to the reagent master, the allowable ranges are “5.55 to 5.75” and “−9999999 to 9999999” for pH and EC, respectively. Therefore, it is determined to be within the management range. The dispensing reagent “20030501” has an OD of “0.61”. The allowable range of the reagent “HH1SRS” with this management number is “0.85” as the lower limit of the OD when referring to the reagent master. Therefore, the CPU 23 stores that the reagent “HH1SRS” is not within the management range (step S23 in FIG. 9).

  The CPU 23 displays a pre-measurement processing result screen (step S25). In this case, the memory in step S15, step S19, and step S23 is displayed as an alarm depending on the degree. In the present embodiment, as shown in FIG. 10, when the alarm date is exceeded, the corresponding part is displayed in yellow, and when the expiration date or out of the management range, the corresponding part is displayed in red. This is reported to the operator with a red alarm. In FIG. 10, an alarm relating to the device is displayed in the area 51, and an alarm relating to the reagent is displayed in the area 53.

  The operator performs measurement when the pre-measurement processing is completed. In the following, the calibration curve method was adopted. The calibration curve method is to measure a known solution (standard solution string) under the same conditions as the substance to be measured this time, obtain a calibration curve for the known substance, and measure the characteristics of the unknown substance from the calibration curve. Say the method.

  When the pre-measurement process is completed, the CPU 23 executes a post-measurement process (step S5 in FIG. 8). The post-measurement process will be described with reference to FIG. The operator inputs the measurement result (step S41). In this embodiment, a measurement value of calibration curve data for obtaining a calibration curve and a measurement value of sample data are input. In this case, as shown in FIG. 12A, as calibration curve data, the concentrations are “BL11”, “0.511”, “0.605”, “0.642”, and the concentrations are “2 μg / ml”, “0.023”, “ Assume that “1.575”, “1.474”, and “1.290” are input at 1.040 ”and“ 1.047 ”at concentrations of“ 4 μg / ml ”. As shown in FIG. 12B, the sample name “TSY004-4-K” is measured three times as the sample data, and as the measurement raw data, the dilution rate “10” and the collected amount “1.0” are obtained. ", 1.064", "1.124", "1.049", dilution rate "20", collection amount "0.5", "1.017", "1.020", "1.030", dilution rate "40", collection “1.021”, “1.028”, “1.022” are input for the quantity “2.0”, and the sample name “TSY005-4-K” is measured twice, and the measurement raw data is diluted. “1.069”, “1.074”, “1.083” for the magnification “20” and the collection amount “1.0” and “1.596”, “1.668”, “1.615” for the dilution rate “10” and the collection amount “1.0” are input. Shall be.

  The concentration “BL” refers to a blank state in which the detection target substance is not contained in the solution.

  As for the calibration curve data, there may be data that the measured value is clearly incorrect. In this case, the value is “0.023” when the concentration is “2 μg / ml”. Since such data is an obvious error, when the operator inputs this data, he / she can delete the data because he / she thinks that there is some measurement error.

  Such calibration curve data deletion processing is executed by interrupt processing. The calibration curve data deletion process will be described with reference to FIG. When the calibration curve data is input, the CPU 23 displays an input result display screen as shown in FIG. 14A. The operator sees this and clicks the check box of the item to be deleted. In this case, since the value “0.023” when the concentration is “2 μg / ml” can be determined as an obvious error, the check box 71 is clicked to delete this value.

  Upon receiving such a click, the CPU 23 executes the interrupt program shown in FIG. First, the screen shown in FIG. 14B is displayed (step S61 in FIG. 13), and it is determined whether or not there is an input in the remarks column (step S63). When the button 58 shown in FIG. 14B is selected while there is an input in the remarks column, the CPU 23 switches the screen to the screen shown in FIG. 14A and displays a yellow alarm in the area 57 shown in FIG. 13A (step in FIG. 13). S65). As described above, unless an explanatory note is input in the remarks column 59, the operator cannot delete data for his own convenience by locking the screen so as to keep this state as it is.

  When the interruption process is completed, the CPU 23 returns to step S43 in FIG. 11, and performs regression analysis, calculation of correction values, calculation of content, and CV value for the calibration curve data from the calibration curve measurement values (step S43 in FIG. 11). First, in regression analysis, regression analysis is performed using a plurality of measured values for each concentration, and a straight line that can be defined is determined. In this case, the relationship between the concentration and the measured value is represented by a straight line 93 as shown in FIG. The straight line 93 is represented by a numerical value a (regression coefficient) and a numerical value b (regression constant) (y = ax + b). For the contribution rate, the correlation coefficient (see JISZ8101) of the measured value of the calibration curve data was obtained, and the value squared was used. The CPU 23 stores this value in the hard disk.

  Next, the CPU 23 calculates, as a correction value, a value obtained by subtracting the average when the density is blank from each measurement value. In this case, since the measured values when the concentration is “BL” are “0.511”, “0.605”, and “0.642”, the average value thereof is “0.586”. Therefore, when the concentration is “2 μg / ml”, the correction values are “0.454” and “0.461”, respectively. The same calculation is performed for the concentration “4 μg / ml”. Note that the measurement value “0.023” has been deleted, but the display remains as it is.

  Next, CPU23 calculates a content, and also calculates a CV value using this. The content conversion and the calculation of the CV value may be performed in the same manner as before. For the content, the obtained correction value is applied to the straight line 93, and the concentration may be taken as the content. For example, if the correction value is “0.888”, the value of the y-axis value is “0.888”, the point intersecting the straight line 93 obtained by regression analysis is obtained, and the value obtained by multiplying the x-axis value by the dilution factor is the content. It becomes. The CV value can be obtained by obtaining the standard deviation for a plurality of measured values for each concentration, dividing the result by the average value, and expressing the obtained value as a percentage. Thus, as the CV value, the measured value “0.511”, “0.605”, “0.642” at the concentration BL is the value “11.5”, and the measured value “0.023” when the concentration is “2 μg / ml”. , “1.040” and “1.047”, the value “1.1” is obtained, and the value “16.8” is obtained from the measured values “1.575”, “1.474” and “1.290” when the concentration is “4 μg / ml”. The CPU 23 stores the obtained value in the hard disk.

  Next, the CPU 23 determines whether or not the correction value, CV value, regression coefficient, regression constant, and contribution rate obtained from the measurement value of the calibration curve are within a predetermined range (step S45 in FIG. 11). Specifically, the correction value of the reference product master (see FIG. 7) is within the management range, the CV value is within the management range, the regression coefficient is within the management range, the regression constant is within the management range, or the contribution rate is managed. What is necessary is to judge whether it is within the width. If the CPU 23 determines that it is not within the predetermined range, it stores the item as a red alarm (step S47). In this case, when the correction value is concentration 2, the regression coefficient a is “0.2014”, which is below the regression coefficient management width lower limit “0.2123” stored in the reference product master, and the regression constant b is the regression constant. The management width upper limit “0.0261” is exceeded. Further, since the contribution rate is below the contribution rate management width lower limit “0.999”, all of the regression coefficient, the regression constant, and the contribution rate are stored as a red alarm. If these values are abnormal, the basic data to be inspected is not within a predetermined range, and thus the test needs to be repeated.

  Next, the CPU 23 calculates the content and CV value from the sample data (step S49). The calculation method for the content and the CV value is the same as in the case of the calibration curve data, and a description thereof will be omitted.

  Next, the CPU 23 determines whether there is any abnormality in the sample data (step S51). Specifically, it is determined whether the correction value is within the range of the upper and lower limits of the calibration curve of the reference product master (see FIG. 7) or within the range of the content applied to the calibration curve, and whether the CV value is within the management range. If the CPU 23 determines that it is not within the predetermined range, it stores the item as a red alarm (step S53).

  In this case, the sample name TSY004-4-K-2, sample name TSY004-4-K-3, and sample name TSY005-4-K-2 are stored as red alarms as correction values. Whether or not the correction value is within the range is determined as follows. The upper and lower limits of the numerical range of the straight line 93 are numerical values in the case of a concentration of 2 to 4 μg / ml. In this case, the lower limit is “0.4575” and the upper limit is “0.8603” when substituted for the values a and b of the straight line 93. I understand that. Therefore, for the sample name TSY004-4-K-2, the correction values are 0.431,0.434,0.444, which corresponds to a red alarm. The same applies to the sample name TSY004-4-K-3. For the sample name TSY005-4-K-2, the average value of the correction values also exceeds the upper limit. Therefore, this is also stored as a red alarm.

  As the content, the specimen name TSY005-4-K-2 is stored as a red alarm. This is because the average value of content / dilution rate / value (48.94 ÷ 10 ÷ 1.0 = 4.894) of the sample exceeds the upper limit “4” of the calibration curve.

  As for the CV value, the sample name TSY004-4-K-1 exceeds the upper limit “5” of the sample CV. Therefore, this is also stored as a red alarm.

  The CPU 23 displays each value and alarm on a screen as shown in FIG. 16 (step S55). Note that the form shown in FIG. 16 may be created in advance and only numerical values may be substituted. The operator sees such a display and knows that there is a red alarm in the calibration curve data as well as the sample data.

  In the calibration curve method, if the calibration curve data is not reliable, the test itself cannot be established in the first place. Therefore, regardless of the numerical value of the specimen data, the operator can grasp that the retest is necessary. In addition, when there is a red alarm only in the sample data, it is possible to know that the calibration curve data is reliable and the sample data is not reliable. In addition, when there is a red alarm only in the calibration curve data, it can be understood that there is a possibility that the sample data may be abnormal if the calibration data is unreliable but the sample data has no alarm.

  Note that the calibration curve data is not necessarily deleted at the time of data input, but may be performed after the sample data content is once calculated. This is because the timing noticed by the operator is unknown. Further, since the calibration curve data is also used for the calculation of the content of the sample data, etc., if the data is deleted during the process, the processing from step S43 is repeated.

  As described above, in the present embodiment, an abnormality in the device and reagent used for the inspection is detected before the measurement, and the operator is notified. Accordingly, it is possible to confirm in advance the check omission before use of the device / reagent, the omission of report on occurrence of abnormality in measurement data and measurement operation, and the recheck of the validity of measurement.

  In particular, it is easy to find anomalies even when the management method is not unified, such as the equipment maintenance check record is closed by the month and the reagent preparation record is closed by the day. In addition, it is possible to reliably notify the operator of the use device or the reagent used that may cause quality degradation.

5. Other Embodiments In this embodiment, the CV value is detected by taking the aluminum content test as an example, but this is a different item depending on the test content. That is, for a specific test, the management range of the characteristic value for determining the measurement result may be stored.

  In addition, not only the test reagent but also, for example, a standard product or a measurement accuracy control product (QC control) can be similarly notified of an abnormality. Since the standard product and QC control differ depending on the test, the correspondence information (for example, table) of the standard product and QC control used for each prepared reagent is separately stored, and when the prepared reagent is determined, the corresponding information is obtained. The standard product and the QC control are determined, the allowable range is read, and the same determination may be made.

  In addition, the permissible management data is stored for the specimen to be inspected instead of the test equipment or the test substance used for the test as described above, and the test result is not within the permissible management data range. This may be notified to the operator.

  In addition, data that deviates from the management range of the characteristic values that judge the measurement results and explanations that are entered or selected by the operator are searched, and which process in which test is abnormal is printed on the screen or this. Thus, the reliability of the inspection method may be notified to the operator or a third party.

  In the present embodiment, the inspection effective date itself is stored as the inspection device deadline determination data, but information for determining the inspection effective date may be stored. The same applies to the reagent expiration date determination data.

  Moreover, although the case where the calibration curve method was employed as the analysis method has been described, the present invention is not limited to this, and other analysis methods such as a parallel line quantification method may be employed.

  In this embodiment, in order to realize the function shown in FIG. 1, a CPU is used and this is realized by software. However, some or all of them may be realized by hardware such as a logic circuit.

  In addition, you may make it make an operating system (OS) process a part of said program.

It is a functional block diagram of inspection device 1 concerning the present invention. It is a figure which shows an example of the hardware constitution which implement | achieved the test | inspection apparatus 1 using CPU. The data structure of an instrument / reagent configuration master is shown. The data structure of a reagent master is shown. The data structure of an equipment master is shown. The data structure of a reagent preparation master is shown. The data structure of the reference product master is shown. It is the whole flowchart. It is a flowchart of a measurement pre-process. It is an example of an alarm display screen before measurement. It is a flowchart of a measurement post-process. This is test result data to be input. It is a flowchart of the data deletion process of calibration curve data. It is a display example of a screen in data deletion processing of calibration curve data. It is a figure explaining linearity. It is an example of an alarm display screen after measurement.

Explanation of symbols

1 ... Inspection device 23 ... CPU
27 ... Memory

Claims (6)

Inspection device data storage means for storing inspection device expiration date determining data for determining the expiration date of the inspection device used for the inspection;
Test reagent data storage means for storing test reagent expiration date determination data for determining the expiration date of the test reagent used for the inspection,
Test ID-specific correspondence data storage means for storing test ID-specific correspondence data in which a test device and a test reagent are associated with a test ID,
Input means for inputting the inspection ID and the inspection date;
An instrument reagent determining means for determining a test instrument and a test reagent corresponding to the test ID from the test ID corresponding data stored in the test ID corresponding data storage means using the input test ID as a key,
For the test equipment and test reagent determined by the equipment reagent determination means, the test equipment time limit determination data for the equipment used from the test equipment data storage means, and the test reagent time limit for the test reagent from the test reagent data storage means The determination data is read out, the device inspection time limit and the test reagent time limit are determined using the test device time limit determination data and the test reagent time limit determination data, and the input test date is the device test time limit and the test reagent time limit. Time limit judging means for judging whether or not
If the test date exceeds either the device test deadline or the test reagent deadline, or both, a reporting means for notifying this,
An inspection apparatus that exists independently of the inspection equipment. An inspection method for inspecting whether the inspection device and the inspection reagent are appropriate before inspection using a computer that exists independently of the inspection device,
In the storage unit of the computer, 1) device reagent correspondence data in which a test device and a test reagent are associated with a test ID, 2) test device time limit determination data for determining a test time limit for each test device, 3) Store test reagent expiration date determination data for determining the expiration date of the test reagent used for each test,
When the test ID is input, the computer determines a test device and a test reagent corresponding to the test ID from the device reagent corresponding data using the test ID as a key,
Using the test instrument deadline determination data and the test reagent deadline determination data, the instrument test deadline and the test reagent deadline are determined, and the given test date is either the test instrument deadline or the test reagent deadline or both. If you are overdue, notify this,
Inspection method using a computer characterized by the above. A program that causes a computer that exists independently of a testing device to function as a testing device that tests whether the testing device and the testing reagent are appropriate before testing,
The computer includes 1) device reagent correspondence data in which a test device and a test reagent are associated with a test ID, 2) test device time limit determination data for determining a test time limit for each test device, and 3) each of the above Test reagent expiration date determination data for determining the expiration date of the test reagent used for the test is stored,
Causing the computer to execute the following processing:
When a test ID is input, using the test ID as a key, a test device and a test reagent corresponding to the test ID are determined from the device reagent corresponding data,
Using the test instrument deadline determination data and the test reagent deadline determination data, the instrument test deadline and the test reagent deadline are determined, and the given test date is either the test instrument deadline or the test reagent deadline or both. If you are overdue, notify this,
A program characterized by The program according to claim 3, further causing the following processing to be executed:
In the storage unit of the computer, the allowed management data of the reagent characteristic values determined in order for the test reagent to function as a reagent, and the measured reagent characteristic value measured for each test reagent,
For the determined test reagent, it is determined whether the measurement reagent characteristic value is within the allowable management data range,
If the measurement reagent characteristic value is not within the allowable management data range, let the operator know this,
A program characterized by The program according to claim 4, further causing the following processing to be executed:
A) The following 1) to 3) are stored in the storage unit of the computer,
1) Standard products and quality control products used for testing for each test reagent
2) As the tolerance management data, in addition to the inspection reagent characteristic value tolerance management data, the standard article tolerance management data of the standard product used in the examination and the tolerance management data of the quality control article used in the examination,
3) Measurement standard product characteristic value and measurement accuracy control product characteristic value obtained by measuring the standard product and quality control product using the determined test reagent,
B) Determine whether the measurement standard product characteristic value and / or measurement accuracy management product characteristic value is within the range of the allowable management data, and the measurement standard product characteristic value and / or measurement accuracy management product characteristic value If not within the allowable management data range, let the operator know this,
It is characterized by. In the program according to claim 5, further allowing the following processing to be executed, storing the allowable management data of the specimen to be examined in the storage unit of the computer,
Determining whether the measurement value of the specimen to be examined is within the range of the allowable management data, and if not within the allowable management data range, notifying the operator of this,
It is characterized by.

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