Automatic analysis device and automatic analysis method

Abstract

The present invention provides an automatic analysis device, comprising a control unit for controlling analysis, wherein the analysis uses multiple calibration lines with different quantitative ranges for an object detection body, and the control unit performs the following steps: obtaining multiple measurement results including multiple measurement values ​​using the multiple calibration lines, and when an abnormality is detected during measurement using the multiple calibration lines, annotating a data alarm corresponding to the category of the abnormality with respect to a measurement result using a corresponding calibration line among the multiple measurement results; and when multiple data alarms are annotated among the multiple measurement results, determining the measurement results and data alarms to be output based on the multiple measurement results and the multiple data alarms.

Description

[0001] This application is a divisional application of the original application, whose application date is September 6, 2018, application number is 201880058137.9, and invention name is “Automatic Analysis Device and Automatic Analysis Method”. Technical Field

[0002] The present invention relates to a technique for an automatic analyzer for clinical examination and a technique for outputting an alarm corresponding to an abnormality, an error, etc. in the automatic analyzer. Background Art

[0003] The automatic analyzer for clinical examination detects the concentration and amount of target component substances contained in a test body (also called a sample) such as blood or urine based on optical measurements. As a method for detecting target component substances, the absorptiometry method for measuring the amount of transmitted light of the test body is often used. In the absorptiometry method, light from a light source is irradiated onto the test body or the reaction liquid (a mixture of the test body and a reagent), and the amount of transmitted light of one or more wavelengths obtained from the result is measured, and the absorbance is calculated. In addition, in the absorptiometry method, according to the Lambert-Beer law, the amount of the target component substance is obtained by the relationship between absorbance and concentration.

[0004] In addition, as an automatic analysis device for clinical examination, there is known a device that realizes high sensitivity of immunoassay using, for example, a light scattering detection method, which utilizes the change in the amount of scattered light and is easy to capture a larger change in the amount of light. In the light scattering detection method, light is irradiated to an agglomerate generated by an antigen-antibody reaction, and at least one of the amount of light or the intensity of light scattered by the agglomerate is measured. In addition, in the light scattering detection method, the amount of the target component substance is obtained by the relationship between the amount of light or the intensity of light and the concentration.

[0005] There are differences in characteristics between the photometer using the absorption photometry method, i.e., the absorptiophotometer, and the photometer using the light scattering detection method, i.e., the scatterophotometer, including the range that can be measured and quantified (sometimes described as "quantitative range", etc.). Therefore, in recent years, an automatic analyzer has been developed that utilizes the difference in characteristics of the two types of photometers, mounts the two types of photometers in one unit, and expands the dynamic range of the measurement.

[0006] As a prior art example related to the automatic analyzer, Japanese Patent Application Laid-Open No. 2014-6160 (Patent Document 1) is cited. Patent Document 1 describes, as an automatic analyzer, a scattering photometer and an absorptiophotometer that can determine the best photometer according to the concentration range.

[0007] Prior art literature

[0008] Patent Literature

[0009] Patent Document 1: Japanese Patent Application Publication No. 2014-6160 Summary of the invention

[0010] Problems to be solved by the invention

[0011] However, in order to improve the reliability of the measurement results, most automatic analyzers for clinical examinations have the following alarm output function (sometimes described as a data alarm function). In this function, when an abnormality, error, etc. in the measurement is monitored and detected, predetermined data representing the category of the abnormality, etc. is annotated as a data alarm in the measurement result information and output.

[0012] When the abnormality during measurement is minor, for example, after taking measures such as sample dilution, it is highly likely that a suitable measurement result can be obtained by re-measurement, etc. Therefore, an automatic analyzer having a function of automatically performing a re-inspection including re-measurement according to the abnormality (sometimes described as an automatic re-inspection function) has been developed.

[0013] For example, in the automatic analysis device of patent document 1, a method for selecting output from the measurement results of two photometers in the case of normal measurement, in other words, when no abnormality is detected, etc. is disclosed. However, in the automatic analysis device having more than two photometers and having a data alarm function and a function of selecting measurement results, etc., it is not studied how to select output from more than two measurement results and data alarms when there is an abnormality during measurement. For example, in this device, when using two photometers for analysis, it may occur that an abnormality is detected by the measurement of each photometer, and each data alarm is annotated on both sides of the two measurement results. That is, there is a situation where more than two data alarms are generated at the same time. In this case, it is not clear how to select the output to the user appropriately.

[0014] In the above-mentioned automatic analysis device, in the case of outputting all of a plurality of measurement results and data alarms or in the case of selecting a measurement result and data alarm and outputting them, in either case, it is sometimes difficult for the user to make a judgment. As a user, it is difficult to understand what state or meaning the output represents, and it is necessary to judge the correctness and suitability of the measurement, whether re-inspection or response operations are required, etc., and it is necessary to perform operations and operations corresponding to the judgment. That is, in the above-mentioned automatic analysis device, the user has a heavy burden on the output, which may cause judgment errors, delayed result reporting, etc.

[0015] Furthermore, in the above-mentioned automatic analyzer, when considering the combination with the automatic retest function, no study has been conducted on how to appropriately control re-measurement when two or more data alarms are generated, and the automatic retest function cannot be effectively utilized.

[0016] The object of the present invention is to provide a technology, which relates to a technology of an automatic analysis device having two or more photometers, and can realize appropriate output from the measurement results and data alarms of the multiple photometers even when there is an abnormality during measurement. That is, to provide a technology that can reduce the burden of the user on the output and can prevent misjudgment, delay in result reporting, etc. In addition, another object of the present invention is to provide a technology that can realize more accurate measurement at high speed through appropriate re-measurement control even in the case of an automatic analysis device with an automatic re-test function.

[0017] Means for solving problems

[0018] A representative embodiment of the present invention is an automatic analyzer, characterized by having the following configuration. The automatic analyzer of one embodiment comprises: a plurality of photometers having different quantitative ranges, and an analysis control unit for controlling analysis, wherein the analysis includes measurement of a target test body using the plurality of photometers, and the analysis control unit performs: obtaining a plurality of measurement results including a plurality of measurement values ​​using the plurality of photometers; when an abnormality is detected during measurement using the plurality of photometers, a data alarm corresponding to the type of the abnormality is annotated in the measurement result using the corresponding photometer among the plurality of measurement results; when a plurality of data alarms are annotated in the plurality of measurement results, the measurement result and data alarm to be output are selected from the plurality of measurement results and the plurality of data alarms in accordance with the combination of the plurality of data alarms, and the selected measurement result and data alarm are output to the user as analysis results.

[0019] Effects of the Invention

[0020] According to a representative embodiment of the present invention, a technology for an automatic analyzer having two or more photometers is provided, and even in the case of abnormality during measurement, appropriate output can be achieved from the measurement results and data alarms of the multiple photometers. That is, the burden on the user for output can be reduced, and misjudgment, delay in result reporting, etc. can be prevented. In addition, according to a representative embodiment, in the case of an automatic analyzer further having an automatic re-test function, more accurate measurement can be achieved at high speed through appropriate re-measurement control. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1This is a diagram showing the overall schematic configuration of an automatic analyzer according to Embodiment 1 of the present invention.

[0022] Figure 2 This is a diagram mainly showing the functional block configuration of the analysis control unit in the automatic analyzer according to the first embodiment.

[0023] Figure 3 This is a diagram showing the characteristics of two types of photometers in the automatic analyzer according to the first embodiment.

[0024] Figure 4 This is a diagram showing a table showing the classification definition of data alarms in the automatic analysis device according to the first embodiment.

[0025] Figure 5 This is a diagram showing the first part as a correspondence table between data alarms and outputs in the automatic analyzer according to the first embodiment.

[0026] Figure 6 This is a diagram showing the second part as a correspondence table in the automatic analyzer according to the first embodiment.

[0027] Figure 7 This is a diagram showing the third portion as a correspondence table in the automatic analyzer according to the first embodiment.

[0028] Figure 8 This is a diagram showing the fourth portion as a correspondence table in the automatic analyzer according to the first embodiment.

[0029] Fig. 9 This is a diagram showing the flow of output control processing in the automatic analyzer according to the first embodiment.

[0030] Fig.10 This is a diagram showing the flow of the priority output alarm determination process in the first embodiment.

[0031] Fig.11 This is a diagram showing the flow of high-level data alarm processing in the first embodiment.

[0032] Fig.12 This is a diagram showing the flow of the first part of the medium-level data alarm process in the first embodiment.

[0033] Fig.13 This is a diagram showing the flow of the second part of the medium-level data alarm process in the first embodiment.

[0034] Fig.14 This is a diagram showing the flow of low-level data alarm processing in the first embodiment.

[0035] Fig.15 This is a diagram showing an example of a processing flow in the automatic analyzer according to the second embodiment of the present invention.

[0036] Fig.16 This is a diagram showing the flow of the first part of the medium-level data alarm process in the automatic analyzer according to the third embodiment of the present invention.

[0037] Fig.17 This is a diagram showing the flow of the second part of the medium-level data alarm process in the third embodiment. DETAILED DESCRIPTION

[0038] Hereinafter, embodiments of the present invention will be described in detail based on the accompanying drawings. In addition, in principle, the same reference numerals are given to the same parts in all the drawings for describing the embodiments, and their repeated descriptions are omitted.

[0039] [Topics, etc.]

[0040] Supplementary explanation of the premise, topics, etc. For the reaction between the test body and the reagent, two types of reactions are used, namely, color reaction and agglutination reaction. Color reaction is a reaction between a substrate and an enzyme, and is used in biochemical analysis. In biochemical analysis, the amount of light absorbed by the colored reaction solution (expressed as absorbance) is measured to find the amount of the component. Agglutination reaction is a reaction between an antigen and an antibody, and is used in immunoassay. In immunoassay, the turbidity of the reaction solution that changes due to the agglutination of the antigen and the antibody is measured based on the change in the amount of transmitted light (expressed as turbidity) to find the amount of the component. The target component substance measured by immunoassay usually has a low concentration in the blood, and a highly sensitive detection system is desired. Therefore, in immunoassay, latex immunoturbidimetry and the like have been developed. In latex immunoturbidimetry, a reagent that sensitizes and binds antibodies or antigens on the surface of latex particles is used to increase the size of the agglutinated block generated by the antigen-antibody reaction, thereby increasing the turbidity change and achieving a highly sensitive measurement.

[0041] Generally speaking, the light scattering detection method has high detection sensitivity and good quantitative properties for low-concentration detection bodies, but for high-concentration detection bodies, there are more agglomerates, and the quantitative properties are not good due to the influence of multiple scattering. On the other hand, generally speaking, the absorption photometry method has low detection sensitivity for low-concentration detection bodies, but compared with the light scattering detection method, it has good quantitative properties for high-concentration detection bodies and a wide concentration range that can be quantitatively determined. As mentioned above, there are differences in characteristics including the range that can be measured and quantified between the photometer using the absorption photometry method, i.e., the absorption photometer, and the photometer using the light scattering detection method, i.e., the scattering photometer. Therefore, in recent years, an automatic analyzer has been developed that utilizes the difference in characteristics of the two types of photometers, mounts the two types of photometers in one unit, and expands the dynamic range of the measurement. In the automatic analyzer, for example, the measurement results of the scattering photometer are used in the low-concentration area, and the measurement results of the absorption photometer are used in the high-concentration area.

[0042] Patent Document 1 discloses a method of selecting a photometer with high sensitivity based on the deviation of the measured values ​​of the standard solution used in the preparation of the calibration line of each photometer, and discloses a method of presetting a plurality of concentration ranges and switching between two photometers according to the concentration range to which the measured value of the photometer is suitable.

[0043] As an automatic analyzer of a comparative example relative to the embodiment of the present invention, an automatic analyzer having two conventional photometers, an absorptometer using an absorptometer method and a scattering photometer using a light scattering detection method, is considered. In addition, the automatic analyzer has a function of using two photometers to perform measurements and analyses simultaneously, i.e., a simultaneous analysis function. In addition, the automatic analyzer has a function of annotating a data alarm in the measurement result based on the detection of abnormalities during measurement, i.e., a data alarm function. In addition, the automatic analyzer has a function of selecting a suitable measurement result from the measurement results of the two photometers for output based on a predetermined judgment when performing simultaneous analysis. As a judgment criterion and method for the output selection, for example, a method of selecting the measurement result of the photometer having a suitable quantitative range for the concentration of the object detection body can be cited.

[0044] However, in the automatic analyzer of this comparative example, when simultaneous analysis is performed, in the case of abnormality during measurement, there is a situation where two data alarms are generated according to two measurement results. The measurement results and data alarms are obtained independently by an absorptiophotometer and a scattering photometer. In the past, it has not been studied how to select the measurement results and data alarms to be output from the two measurement results and data alarms in this case. In the device of the comparative example, when the above-mentioned two measurement results and data alarms are generated, selecting the measurement results and data alarms of the less reliable party to be output will cause the user's misjudgment, result report delay, etc., and is therefore not preferred.

[0045] (Implementation Method 1)

[0046] use Figure 1 to Figure 14 The automatic analysis device and the automatic analysis method according to the first embodiment of the present invention will be described. The automatic analysis method according to the first embodiment is a method having steps executed in the automatic analysis device according to the first embodiment.

[0047] The automatic analyzer of Embodiment 1 is provided with an absorbance photometer and a scattering photometer as two types of photometers, and has a data alarm function and a simultaneous analysis function, etc. The data alarm function is a function of adding a data alarm corresponding to the abnormality, etc. to the measurement result when an abnormality, etc. is detected during measurement. The simultaneous analysis function is a function of performing measurement and analysis simultaneously using two photometers ("absorption and scattering simultaneous analysis"). The automatic analyzer of Embodiment 1 has a function of selecting a suitable measurement result from a plurality of measurement results according to the target component substance of the inspection item and the suitable quantitative range of various photometers when performing simultaneous analysis, and can perform measurement over a wide dynamic range.

[0048] Furthermore, the automatic analyzer of Embodiment 1 has a function (sometimes described as an output control function) of appropriately selecting and outputting the measurement results and data alarms even when two measurement results and data alarms are obtained due to abnormalities during measurement, etc., during simultaneous analysis. In this function, the measurement results and data alarms to be output are appropriately selected according to the combination of data alarms. In addition, the measurement results include quantitative values ​​such as measurement values ​​and calculated values, signal values, analysis result information, etc.

[0049] Furthermore, the automatic analyzer of the first embodiment also has an automatic retest function, and even when two measurement results and data alarms are obtained as described above, the automatic retest is appropriately controlled by the output control function. That is, the automatic analyzer of the first embodiment appropriately selects the measurement result, data alarm, and automatic retest information to be output according to the combination of data alarms, and controls automatic retest, etc. In addition, the automatic retest information includes whether automatic retest is required, identification information of the photometer used, retest conditions (such as dilution of the sample, etc.), etc.

[0050] [Automatic analysis device]

[0051] Figure 1 1 is a schematic diagram showing the overall structure of the automatic analyzer 1 according to the first embodiment. The automatic analyzer 1 includes: a sample disk 10, a reaction disk 20, a reagent disk 30, a sample dispensing mechanism 41, a reagent dispensing mechanism 42, a computer 100, an interface circuit 101, etc. The sample disk 10 includes a driving unit 12. The reaction disk 20 includes a driving unit 22. The reagent disk 30 includes a driving unit 32. In addition, the reaction disk 20 is provided with two types of photometers, namely, an absorbance photometer 44 and a scattering photometer 45. In addition, the reaction disk 20 is provided with a constant temperature bath 28. In addition, the reaction disk 20 is provided with a stirring unit 43, a cleaning unit 46, etc.

[0052] The computer 100 includes: an analysis control unit 50, a storage unit 70, an output unit 71, an input unit 72, etc. The analysis control unit 50 is connected to each drive unit and each mechanism through an interface circuit 101 including a signal line, etc. The computer 100 is composed of, for example, a PC, but is not limited thereto, and may also be composed of a circuit substrate such as an LSI substrate, or may be composed of a combination thereof. The storage unit 70 is composed of a storage device such as a ROM, a RAM, or a non-volatile storage device.

[0053] A plurality of sample cups 15 are provided and held in the sample disk 10. The sample cups 15 are sample containers that contain the sample 2. The sample cups 15 are held in parallel and spaced apart from each other in the circumferential direction on the disk body 11 of the sample disk 10.

[0054] The driving unit 12 of the sample disk 10 is driven according to the analysis control unit 50 ( Figure 2 The sample disk 10 is driven and controlled by the control unit 53 of the control unit 53. At this time, the driving unit 12 rotates the disk body 11, thereby moving the plurality of sample cups 15 in the circumferential direction. The sample disk 10 is driven and controlled by the driving unit 12, so that one of the plurality of sample cups 15 provided in the disk body 11 is arranged at a predetermined position in the circumferential direction. The predetermined position is, for example, the sample suction position of the sample dispensing mechanism 41.

[0055] In addition, Figure 1 In the example of the configuration, in the sample disk 10, a plurality of sample cups 15 are arranged in a row on the disk body 11 along the circumferential direction. However, the configuration is not limited thereto, and the sample cups 15 may be arranged in a plurality of rows in a concentric circle shape on the disk body 11. Figure 1 In the configuration example, the sample tray 15 is provided in a tray type, but the present invention is not limited thereto and may be provided in a rack type. In the rack type, a sample rack is used which arranges and holds a plurality of sample containers in one or two dimensions.

[0056] The reagent disk 30 is arranged next to the reaction disk 20. A plurality of reagent bottles 35 are arranged and held in the disk body 31 of the reagent disk 30. The reagent bottles 35 are reagent containers for containing reagents 4. The reagent bottles 35 are separated from each other along the circumferential direction of the disk body 31 and are held in a side-by-side arrangement. The reagent bottles 35 contain reagents 4 of a type corresponding to the target component substance of the inspection item in the automatic analyzer 1. Each reagent 4 is contained in a different reagent bottle 35 according to its type.

[0057] The driving unit 32 of the reagent disk 30 rotates the disk body 31 and moves the plurality of reagent bottles 35 in the circumferential direction according to the control from the analysis control unit 50. The reagent disk 30 arranges a reagent bottle 35 to be used among the plurality of reagent bottles 35 provided in the disk body 31 at a predetermined position of the reagent disk 30 through the driving control of the driving unit 32. The predetermined position is, for example, a reagent suction position of the reagent dispensing mechanism 42.

[0058] A reagent refrigerator 38 having a cooling mechanism is provided in the reagent disk 30. Even if the disk body 31 rotates, the plurality of reagent bottles 35 arranged on the disk body 31 are cooled while being constantly kept in the cooling environment of the reagent refrigerator 38. Thus, the degradation of the reagent 4 is prevented. As the cooling mechanism of the reagent refrigerator 38, for example, a method of circulating low-temperature water or a method of cooling in a gas phase by a Peltier element can be used.

[0059] The reaction disk 20 is arranged between the sample disk 10 and the reagent disk 30. A plurality of reaction containers 25 are arranged and held in the disk body 21 of the reaction disk 20. The reaction container 25 is a container for preparing a reaction solution 3. The reaction solution 3 is a mixed solution of the sample 2 and the reagent 4. The sample 2 is dispensed into the reaction container 25 by the sample dispensing mechanism 41, and the reagent 4 is dispensed by the reagent dispensing mechanism 42, and the reaction solution 3 is prepared by the mixed solution of the sample 2 and the reagent 4. The reaction containers 25 are separated from each other along the circumferential direction of the disk body 21 and are held in a side-by-side arrangement. In order to perform measurements based on the absorption photometer 44 and the scattering photometer 45, the reaction container 25 is made of a light-transmitting material. The driving unit 22 of the reaction disk 20 rotates the disk body 21 according to the control from the analysis control unit 50, thereby moving the plurality of reaction containers 25 in the circumferential direction. The reaction disk 20 arranges one of the plurality of reaction containers 25 at a predetermined position arranged in the circumferential direction by the rotation of the disk body 21. The predetermined position is, for example, a sample discharging position of the sample dispensing mechanism 41 , a reagent discharging position of the reagent dispensing mechanism 42 , or the like.

[0060] The plurality of reaction containers 25 disposed on the disk body 21 of the reaction disk 20 are always immersed in the thermostatic bath water (also referred to as the thermostatic fluid) in the thermostatic bath 28. Thus, the reaction solution 3 in the reaction container 25 is maintained at a fixed reaction temperature (e.g., about 37°C). The thermostatic bath water in the thermostatic bath 28 is controlled by the analysis control unit 50 ( Figure 2 A constant temperature fluid control unit 54 is used to control the temperature and flow rate, thereby controlling the heat supplied to the reaction container 25.

[0061] On and near the circumference of the reaction disk 20, in addition to the sample dispensing mechanism 41 and the reagent dispensing mechanism 42, a stirring unit 43, an absorptiophotometer 44, a scatterphotometer 45, a cleaning unit 46, etc. are arranged at different positions.

[0062] The sample dispensing mechanism 41 is provided between the sample disk 10 and the reaction disk 20. The sample dispensing mechanism 41 performs a sample dispensing operation, which is an operation of sucking the sample 2 from the sample cup 15 at the sample suction position of the sample disk 10 and discharging it into the reaction container 25 at the sample discharge position of the reaction disk 20. The sample dispensing mechanism 41 includes a movable arm and a dispensing nozzle. The dispensing nozzle is composed of a pipette nozzle mounted on the movable arm. During the sample dispensing operation, the sample dispensing mechanism 41 moves the dispensing nozzle to the sample suction position on the sample disk 10, sucks a predetermined amount of the sample 2 from the sample cup 15 arranged at the sample suction position, and accommodates it in the dispensing nozzle. Thereafter, the sample dispensing mechanism 41 moves the dispensing nozzle to the sample discharge position on the reaction disk 20, and discharges the sample 2 in the dispensing nozzle into the reaction container 25 arranged at the sample discharge position.

[0063] The reagent dispensing mechanism 42 is arranged between the reagent disk 30 and the reaction disk 20. The reagent dispensing mechanism 42 performs the reagent dispensing action, which is the action of sucking the reagent 4 from the reagent bottle 35 at the reagent suction position of the reagent disk 30 and discharging it into the reaction container 25 at the reagent discharge position of the reaction disk 20. The reagent 4 to be dispensed is a reagent used in the quantitative determination of the target component substance in the analysis item (also referred to as the inspection item, etc.) set corresponding to the object detection body 2. The reagent dispensing mechanism 42 is similarly equipped with a movable arm and a dispensing nozzle. When the reagent dispensing mechanism 42 is in the reagent dispensing action, the dispensing nozzle is moved to the reagent suction position on the reagent disk 30, and a predetermined amount of the reagent 4 is sucked from the reagent bottle 35 arranged at the reagent suction position and accommodated in the dispensing nozzle. Thereafter, the reagent dispensing mechanism 42 moves the dispensing nozzle to the reagent discharge position on the reaction disk 20, and discharges the reagent 4 in the dispensing nozzle into the reaction container 25 arranged at the reagent discharge position.

[0064] A cleaning section 46 is provided in each of the sample dispensing mechanism 41 and the reagent dispensing mechanism 42 to prepare for the dispensing of different types of sample 2 or reagent 4. The cleaning section 46 is a mechanism for cleaning the dispensing nozzle. Each dispensing mechanism cleans each dispensing nozzle by the cleaning section 46 before and after the dispensing action. In this way, the sample 2 is prevented from being contaminated with each other or the reagent 4 is prevented from being contaminated with each other. In addition, a sensor for detecting the liquid level of the sample 2 or the liquid level of the reagent 4 is provided in the dispensing nozzle of each dispensing mechanism. In this way, measurement abnormalities caused by insufficient sample 2 or reagent 4 can be monitored and detected. In addition, a pressure sensor for detecting the blockage of the dispensing nozzle is provided in the sample dispensing mechanism 41. In this way, dispensing abnormalities caused by the blockage of the dispensing nozzle by insoluble substances such as fibrin contained in the sample 2 can be monitored and detected. The analysis control unit 50 can monitor and detect various abnormalities during measurement by including a mechanism of these sensors.

[0065] The stirring section 43 stirs the mixed solution of the sample 2 and the reagent 4 in the reaction container 25 arranged at a predetermined position, i.e., the stirring position, on the reaction disk 20. Thus, the mixed solution in the reaction container 25 is uniformly stirred, and the reaction is promoted to form a reaction solution 3. The stirring section 43 is provided with, for example, a stirrer having stirring wings or a stirring mechanism using ultrasonic waves.

[0066] Of the two photometers, a first type of photometer includes an absorbance photometer 44, and a second type of photometer includes a scattering photometer 45. Each of the absorbance photometer 44 and the scattering photometer 45 has a light source and a light receiving unit as a basic structure. The light source of each photometer is, for example, arranged on the inner circumference of the reaction disk 20, and the light receiving unit of each photometer is arranged on the outer circumference of the reaction disk 20. Each photometer is connected to the analysis control unit 50 ( Figure 2 The measuring unit 51) is connected.

[0067] The absorptometer 44 measures the reaction solution 3 of the reaction container 25 arranged at a predetermined position on the reaction disk 20, i.e., a measurement position (particularly, the first measurement position). The scattering photometer 45 measures the reaction solution 3 of the reaction container 25 arranged at a predetermined position on the reaction disk 20, i.e., a measurement position (particularly, the second measurement position). Figure 1 In the configuration example, the two photometers, the absorptometer 44 and the scattering photometer 45, are arranged on the circumference of the reaction disk 20 at predetermined positions opposite to each other on a diagonal line passing through the rotation center of the reaction disk 20. The absorptometer 44 is arranged at the first measurement position, and the scattering photometer 45 is arranged at the second measurement position. In addition, the stirring unit 43 and the cleaning unit 46 are arranged at predetermined positions between the first measurement position and the second measurement position on the circumference.

[0068] The absorptiophotometer 44 irradiates light from a light source to the reaction solution 3 of the reaction container 25 at the first measurement position. At this time, the absorptiophotometer 44 detects the transmitted light obtained from the reaction solution 3 through the light receiving part, and measures at least one of the light quantity or light intensity of the transmitted light of a single or multiple wavelengths (sometimes recorded as light quantity / light intensity). In addition, the absorptiophotometer 44 can also obtain a quantitative value such as concentration through a predetermined calculation based on the measured value. The absorptiophotometer 44 outputs a signal including the measured value or the calculated value.

[0069] The scattered photometer 45 irradiates light from a light source to the reaction solution 3 of the reaction container 25 at the second measurement position. At this time, the scattered photometer 45 detects the scattered light obtained from the reaction solution 3 through the light receiving part, and measures at least one of the light quantity or light intensity of the scattered light (light quantity / light intensity). In addition, the scattered photometer 45 can also obtain a quantitative value such as concentration through a predetermined calculation based on the measured value. The scattered photometer 45 outputs a signal including the measured value or the calculated value.

[0070] The cleaning unit 46 cleans the reaction container 25 arranged at the cleaning position on the reaction disk 20. The cleaning unit 46 discharges the residual reaction solution 3 from the reaction container 25 after the measurement and analysis, and cleans the reaction container 25. The cleaned reaction container 25 can be reused. That is, the next sample 2 is dispensed from the sample dispensing mechanism 41, and the next reagent 4 is dispensed from the reagent dispensing mechanism 42 into the reaction container 25.

[0071] [Analysis and Control Department]

[0072] Figure 2 Mainly indicates Figure 1 The analysis control unit 50 is composed of the functional blocks of the analysis control unit 50 in the structure. The analysis control unit 50 controls the overall automatic analysis device 1 and the automatic analysis sequence, and controls the analysis including the measurement. The analysis control unit 50 is connected to the interface circuit 101, the output unit 71, the input unit 72, etc. The analysis control unit 50 outputs to the output unit 71 (i.e., screen display, sound output, etc.). The analysis control unit 50 receives input from the input unit 72 (i.e., operations performed by the user, etc.). The user of the automatic analysis device 1 performs operations and tasks related to clinical examinations via the output unit 71 and the input unit 72. The output unit 71 includes output devices such as a display device. Through the output control of the analysis control unit 50, information such as measurement results, data alarms, etc. are displayed on the display screen of the display device. The output unit 71 may include a sound output device, and may also emit an alarm sound. The input unit 72 includes input devices such as a keyboard, a mouse, or an operation panel including operation buttons.

[0073] The computer 100 and the analysis control unit 50 can be implemented in an integrated manner by a PC as an installation example, but it is also possible to install without limitation thereto. The analysis control unit 50 executes processing according to a program read from the storage unit 70 by, for example, a microprocessor such as a CPU of the PC. In this way, each unit such as a measuring unit 51 can be implemented. The analysis control unit 50, as a functional block that can be implemented by software program processing, etc., has: a measuring unit 51, an analysis unit 52, a control unit 53, a constant temperature fluid control unit 54, a data storage unit 55, a simultaneous analysis determination unit 56, an automatic re-inspection determination unit 57, a measurement abnormality inspection unit 58, a priority output determination unit 59, and a priority output alarm determination unit 60. The analysis control unit 50 controls various functions including a simultaneous analysis function, a measurement result selection function, a data alarm function, an output control function, and an automatic re-inspection function, which are described later. The analysis control unit 50 mainly performs operation control processing of each mechanism and part of the automatic analyzer 1 and measurement data control processing as analysis processing for the sample 2 with an analysis request through the measurement unit 51, the analysis unit 52 and the control unit 53.

[0074] The data storage unit 55 is configured using the storage unit 70 , and performs reading and writing of various data. The data storage unit 55 stores various data related to analysis, including measurement results, data alarms, and automatic retest information.

[0075] The measuring unit 51 inputs signals including the measured values ​​of two photometers, namely, the absorption photometer 44 and the scattering photometer 45, and performs measurement processing. The measurement processing includes a predetermined calculation. The calculation is, for example, to calculate the concentration of the target component substance based on the light quantity / light intensity as the measured value, or to calculate the light intensity from the light quantity as the measured value. The measuring unit 51 stores the measurement results (measured values, calculated values) in the data storage unit 55 as measurement data.

[0076] The analysis unit 52 refers to the measurement data of the measurement results of the data storage unit 55 and performs analysis processing corresponding to the automatic analysis. The analysis processing is, for example, to use a calibration line to calculate the concentration based on the light intensity of the measurement data. Alternatively, the analysis processing is to use the calculated concentration to calculate the component amount of the target component substance. In addition, the analysis unit 52 determines the presence or absence of abnormalities during measurement for each measurement result of the photometer, and in the case of the presence of such abnormalities, a data alarm indicating such abnormalities is attached to the measurement result. In addition, the judgment of the analysis unit 52 is an independent judgment for each photometer. In addition, when judging the abnormalities during measurement, the analysis unit 52 refers to the control result information stored in the data storage unit 55 by the control unit 53 to make a judgment.

[0077] The control unit 53 is a drive control unit that performs drive control of each mechanism according to the automatic analysis sequence. The control unit 53 performs drive control based on the analysis request information of the target sample 2 stored in the data storage unit 55. The control unit 53 controls each part including each mechanism, such as the drive unit 12, the drive unit 22, the drive unit 32, the sample dispensing mechanism 41, the reagent dispensing mechanism 42, the absorptiophotometer 44, and the scattering photometer 45. For example, the drive unit 12 drives the sample disk 10 to rotate according to the control from the control unit 53. In addition, for example, the control unit 53 drives and controls the sample dispensing mechanism 41 to perform the sample dispensing operation. In addition, for example, the control unit 53 drives and controls the absorptiophotometer 44 to perform measurement at each measurement time in a predetermined period. The control unit 53 controls the operation of each part during analysis, and stores control result information indicating the control state and result in the data storage unit 55. In addition, when an abnormality exists in the mechanism or an abnormality is detected in the mechanism, the control result information contains information indicating the abnormality.

[0078] The control unit 53 rotates each disk such as the sample disk 10, and arranges containers such as the target sample cup 15 at predetermined positions on each disk. As the disk rotates, each container repeats rotational movement and stationary movement of a unit distance on the circumference. The control unit 53 controls the operation of each disk, the sample dispensing mechanism 41, etc., to prepare reaction solutions 3 of a plurality of samples 2 in the plurality of reaction containers 25 on the reaction disk 20. In addition, in the case of simultaneous analysis, the control unit 53 measures the light quantity / light intensity of the reaction solution 3 of the target reaction container 25 arranged at each measurement position on the reaction disk 20 by controlling two photometers.

[0079] The constant temperature fluid control unit 54 controls the temperature and flow rate of the constant temperature bath water in the constant temperature bath 28 of the reaction disk 20 , and adjusts the temperature of the reaction solution 3 in the reaction container 25 .

[0080] The simultaneous analysis determination unit 56 performs determination for output control based on the measurement results of the two photometers during simultaneous analysis and the data alarm. In other words, the automatic re-inspection determination unit 57 is an abnormality determination unit that determines whether automatic re-inspection is necessary based on abnormalities during measurement, etc., for the measurement results using one photometer. The abnormality inspection unit 58 during measurement determines and inspects whether abnormalities, etc. indicated by data alarms, etc. have occurred in the measurement results of the two photometers. The priority output determination unit 59 determines the measurement results to be outputted with priority based on a predetermined determination and a determination of the priority output setting for the measurement results of the two photometers. The priority output alarm determination unit 60 determines the data alarm to be outputted with priority among the two data alarms annotated in the two measurement results.

[0081] [Characteristics of photometer]

[0082] Figure 3The characteristics of the two photometers used in Embodiment 1, namely, the absorptometer 44 and the scatterometer 45, are shown. Figure 3 As shown in Figure 2, the quantitative range characteristics of the two photometers are different. Figure 3 In the graph of , regarding the concentration of the target component substance of the object test body, the horizontal axis is the theoretical value (unit [U / mL]), and the vertical axis is the measured value of each photometer (unit [U / mL]). The dotted area represents the quantitative range of the first photometer, namely the absorptometer 44. The dotted area represents the quantitative range of the second photometer, namely the scattering photometer 45. Range 301 represents the normal output range in the quantitative range of the absorptometer 44. In other words, the normal output range represents the range in which measurement and quantification can be appropriately performed. Range 302 represents the normal output range in the quantitative range of the scattering photometer 45. Range 303 represents the overlapping range of these two ranges 301 and 302. Range 303 is basically the range of measurement results that can be used by any type of photometer. In the analysis control unit 50, for output control, a suitable quantitative range for each photometer is pre-set. That is, respective ranges corresponding to the range 301 , the range 302 , the range 303 , etc. are set (at least an upper limit value, a lower limit value, etc. that define the range are set).

[0083] In the range 301 of the absorptometer 44, the shape has a narrow width (range of measured values ​​relative to theoretical values) with the reference straight line 300 as the center, and has a linear characteristic. In the range with values ​​smaller than the range 301, the shape has a width wider than the reference straight line 300, and has a characteristic with a large error. In the range 302 of the scatterophotometer 45, the shape has a narrow width with the reference straight line 300 as the center, and has a linear characteristic. In the range with values ​​larger than the range 302, the shape has a wide width in the area below the reference straight line 300, and has a characteristic with a large error.

[0084] When the analysis control unit 50 obtains two measurement results in the simultaneous analysis, as described below, based on the judgment of the above-mentioned characteristics (corresponding range), the measurement result to be output is selected. This judgment is included in the provisions of the corresponding table described later. Regarding the concentration of the target component substance, for the range of relatively high concentration (for example, the range above about 10U / mL), as shown in range 301, the quantitative side of the absorptometer 44 is more accurate and appropriate. Therefore, the measurement result of the absorptometer 44 is selected as output. In addition, on the contrary, for the range of relatively low concentration (for example, the range below about 5U / mL), as shown in range 302, the quantitative side of the scattering photometer 45 is more accurate and appropriate. Therefore, the measurement result of the scattering photometer 45 is selected as output.

[0085] In addition, in the relatively medium concentration range corresponding to range 303 (e.g., a range of about 5 U / mL or more and about 10 U / mL or less), both measurement results can be basically used. In the case of this range, for example, according to the priority output setting described later, the measurement result of the photometer of any one type is selected as output. There is a priority output setting for each inspection item.

[0086] [Priority output setting]

[0087] The priority output setting is about the setting of the measurement results and data alarm of which photometer is preferentially used and outputted among the two types of the absorptometer 44 and the scattering photometer 45. The automatic analyzer 1 has a priority output setting function, and the priority output setting is performed in advance by the salesperson as the default setting on the installation, and the corresponding priority output setting information is stored. As the priority output setting information, which photometer is prioritized is set with a value in a predetermined format such as a priority order. The priority output setting information can be set in advance through the input unit 72, for example. In the automatic analyzer 1, the on state or off state of the priority output setting function is also set, and the state can also be variably set by the salesperson or the user. In the case of wanting to invalidate the priority output setting function, it can be set to the off state. As described later, in the case of the on state, the priority output determination is performed based on the priority output setting information, and in the case of the off state, the priority output determination is not performed.

[0088] [Simultaneous absorption and scattering analysis function]

[0089] The automatic analyzer 1 has a simultaneous analysis function, which is a function of using two photometers to simultaneously measure and analyze the target sample 2 based on the characteristics of the two photometers. When the automatic analyzer 1 receives a simultaneous analysis request for the target component substance of the sample 2, it performs absorption and scattering simultaneous analysis. In this function, for the target component substance of the same inspection item of the same sample 2 as the object, measurement using the absorption photometer 44 and measurement using the scattering photometer 45 are performed to obtain two measurement results. At this time, the automatic analyzer 1 uses the two photometers to measure the reaction process of the reaction liquid 3 in the reaction container 25 of the target sample 2 at substantially the same time. In addition, since each measurement is performed at two measurement positions on the reaction disk 20, there is a predetermined time difference. In addition, the reaction process is a continuous measurement process within a predetermined time when the reaction container 25 is stationary at the measurement position of the photometer, including a predetermined multiple measurement at each moment on the time axis.

[0090] Based on the above characteristics, the automatic analyzer 1 selects the appropriate measurement result from the two measurement results when analyzing simultaneously. In the case of a relatively high concentration range (for example, the range after removing the range 303 from the range 301), the automatic analyzer 1 selects the measurement result of the absorptometer 44 for absorptiometry analysis. In the case of a relatively low concentration range (for example, the range after removing the range 303 from the range 302), the automatic analyzer 1 selects the measurement result of the scatterphotometer 45 for a scattered light analysis. Thus, it is possible to accurately perform measurement and analysis in a wide concentration range including high concentrations and low concentrations.

[0091] [Automatic recheck function]

[0092] The automatic analyzer 1 has an automatic re-test function, which is a function of controlling to automatically re-test according to a predetermined judgment when an abnormality is detected during measurement. In Embodiment 1, the automatic re-test function is a function controlled by the association of the data alarm function and the output control function. The output control function includes a function of selecting automatic re-test information for the automatic re-test function.

[0093] In the case of a slight abnormality such as abnormal concentration of the sample, it is estimated that there is a high possibility that a suitable result can be obtained by re-measurement after dealing with the abnormality during measurement, such as dilution of the sample 2, reduction or increase of the sample amount, etc. Therefore, in the automatic analyzer 1, when an abnormality during measurement is detected, whether automatic re-testing is required and the re-testing conditions when required are selected as part of the output automatic re-testing information according to the combination of corresponding data alarms. In addition, the automatic analyzer 1 automatically controls the re-testing according to the automatic re-testing information through the automatic re-testing function, and outputs the re-testing result.

[0094] Furthermore, when an automatic retest is performed, the automatic analyzer 1 takes a new sample 2 from the sample cup 15 storing the target sample 2, and performs reprocessing including dispensing into the reaction container 25, based on the automatic retest request information and the automatic retest information. The automatic analyzer 1 remeasures the reaction container 25 using the selected type of photometer. Furthermore, when a data alarm is further annotated in the result of the automatic retest, the output selection corresponding to the combination of the data alarm may be applied in the same manner, or may be set to a mode in which it is not applied.

[0095] [Data alert function]

[0096] The automatic analysis device 1 has a data alarm function, which is a function of annotating a data alarm indicating a detected abnormality, etc., with respect to the measurement results of the photometer. When the automatic analysis device 1 performs simultaneous analysis, the measurement results of the two photometers are annotated with respective data alarms according to the detection of abnormalities, etc. In particular, when an abnormality, etc., is present during the measurement of the absorptometer 44, the analysis unit 52 annotates a first data alarm indicating the abnormality, etc., in the first measurement result of the absorptometer 44. In addition, when an abnormality, etc., is present during the measurement of the scattering photometer 45, the analysis unit 52 annotates a second data alarm indicating the abnormality, etc., in the second measurement result of the scattering photometer 45. The analysis data including the measurement results annotated with the data alarm is stored in the data storage unit 55.

[0097] [Output control function]

[0098] In the case of abnormality during the above measurement, a data alarm may be added to the measurement results of all (both) of the multiple (two types) photometers. The automatic analyzer 1 has an output control function, which is a function of selecting the measurement results and data alarms to be output according to the combination of data alarms in the above situation. In addition, the output control function includes a function of controlling the automatic re-test function and a function of selecting the automatic re-test information to be output.

[0099] [Examples of abnormalities during measurement, etc.]

[0100] The following are examples of abnormalities, errors, etc. that may occur in the automatic analyzer. Examples of abnormalities in the mechanism include insufficient amount of the test body, insufficient amount of reagents, injection errors caused by blockage of the flow path of fibrin contained in the test body 2, abnormalities in the components of the test body 2, etc. Examples of abnormalities in the components of the test body 2 include abnormal concentration of the test body, where the concentration of the test body 2 is outside the quantitative range of the photometer. That is, examples include the case where the concentration of the test body 2 is too high or too low compared to the quantitative range of the photometer. In addition, examples include the case where the red color of the test body 2 changes due to the dissolution of blood cell components, and the case where the test body 2 becomes turbid, which can be observed in patients with dyslipidemia.

[0101] [Data Alert]

[0102] Figure 4 The following table shows the definitions of the classification of various data alarms that may be outputted by the automatic analyzer 1 according to abnormalities, errors, etc. that may occur. First, various abnormalities and data alarms are described below. Generally speaking, in the automatic analyzer, the technical means for arousing the user's attention based on abnormalities, errors, etc. that occur during measurement and analysis are roughly divided into the following two types.

[0103] The first means is a technique of annotating a data alarm in the measurement result and outputting it. In this technique, identification information indicating normality or abnormality and predetermined information indicating the category of the abnormality, etc., are annotated as a data alarm for each measurement result of a target component substance having one or more inspection items for each sample. The information indicating the category of the abnormality, etc. may be, for example, an identification code, a mark, an explanation text, etc.

[0104] When the information of the measurement result with the data alarm is output from the automatic analyzer, the user can confirm the information by viewing the display screen, thereby being able to identify the category of the abnormality etc. that has occurred. Then, the user performs a response operation etc. according to the abnormality etc. indicated by the data alarm. For example, the user performs a response operation according to the identification code of the data alarm, the operation manual of the automatic analyzer (not limited to paper, but also the guidance in the display screen), etc. The response operation is an operation or operation for improving the state of the abnormality etc. of the automatic analyzer in a way that it can be restored to normal, so that it can be re-inspected.

[0105] The second means is a technique for outputting a system alarm. In this technique, an abnormality related to the entirety of the automatic analyzer, such as temperature abnormality or mechanism abnormality, is used as a system alarm, and an alarm is issued to the user (e.g., sound output). In addition, the system alarm, as a type of data alarm, can also be displayed on the screen as a data alarm with system alarm identification information attached.

[0106] The automatic analysis device 1 of the first embodiment has at least a data alarm function corresponding to the first means. Figure 4 As shown, the automatic analyzer 1 has a plurality of data alarms pre-defined according to the types of abnormalities, etc. In the first embodiment, the plurality of data alarms are roughly divided into three groups and levels as shown below. Figure 4 In the table, (A) indicates a high level and a data alarm of the first group, (B) indicates a medium level and a data alarm of the second group, and (C) indicates a low level and a data alarm of the third group. In addition, high, medium, and low are relative.

[0107] (A) First group and high level: The first group and high level correspond to the following situations, that is, due to the existence of abnormalities, a re-inspection is required in order to obtain accurate measurement results, but for this purpose, the re-inspection can only be performed after the user improves the status. The improvement of the status includes: the improvement of the test body 2, the reagent 4, that is, the improvement of the reaction liquid 3 of the reaction container 25, the improvement of the status of the dispensing mechanism, the cleaning mechanism, etc. The improvement of the status is, for example: when the amount of the test body in the reaction liquid 3 of the reaction container 25 is large, it is changed to a state in which the amount of the test body 2 is reduced, and when the amount of the test body is small, it is changed to a state in which the amount of the test body 2 is increased. In this case, the automatic analyzer 1 outputs a high-level data alarm as an output control so that it does not immediately perform an automatic re-inspection, but prompts the user to perform a response operation and operation including improving the status. The automatic analyzer 1 performs an automatic re-inspection after the status becomes an improved state.

[0108] (B) The second group and the medium level: The second group and the medium level correspond to the following situation, that is, due to the presence of abnormalities, a re-inspection is required, and the re-inspection can be performed without user operation. This situation corresponds to a situation where it can be inferred that a good measurement result can be obtained by re-inspection under the control of the re-measurement conditions. In this case, the automatic analyzer 1 sets the reagent volume of the reaction solution 3 as the same condition as the previous measurement (i.e., the measurement in which the abnormality was detected), or an increased condition, or a decreased condition as the re-measurement condition. In this case, the automatic analyzer 1 outputs a medium-level data alarm, and re-measures under the re-measurement conditions, thereby trying to obtain a good measurement result.

[0109] (C) The third group and low level: The third group and low level correspond to the following cases, that is, the obtained measurement results do not need to be measured again, and the measurement results can be processed as reference values ​​and output. In this case, the automatic analyzer 1 outputs a low-level data alarm.

[0110] The above-mentioned data alarms of each group and level can be further defined as including various data alarms as described below. In addition, each data alarm is provided with an identification code in the description and installation. Examples of identification codes can be represented by "A1", "B1" and the like.

[0111] (A) The first group and high-level data alarms include the following five data alarms. Figure 4 The corresponding table part is shown in (A). In each row of the table, "A1" in brackets and the like represent the identification code of the data alarm. In this example, there are: insufficient test body alarm A1, insufficient reagent alarm A2, blockage detection alarm A3, insufficient detergent alarm A4, photometer abnormality alarm A5.

[0112] (1) Sample Insufficient Alarm A1 is a data alarm generated when it is determined by a liquid level detection sensor or the like provided in the sample dispensing mechanism 41 that the amount of the sample 2 in the reaction solution 3 in the sample cup 15 or the reaction container 25 is insufficient.

[0113] (2) The reagent shortage alarm A2 is a data alarm generated when it is determined by the liquid level detection sensor or the like provided in the reagent dispensing mechanism 42 that the amount of the reagent 4 of the reaction solution 3 in the reagent bottle 35 or the reaction container 25 is insufficient.

[0114] (3) Alarm A3 for detecting clogging is a data alarm generated when a pressure sensor or the like provided in the sample dispensing mechanism 41 determines that a clogging has occurred in the flow path, such as when a foreign object is mixed into the dispensing nozzle when the sample 2 is sucked.

[0115] (4) The cleaning agent shortage alarm A4 is a data alarm generated due to shortage of cleaning agent used for cleaning the dispensing nozzle and the reaction container 25 by the cleaning unit 46 .

[0116] (5) Photometer abnormality alarm A5 is a data alarm generated when an abnormality is detected in the optical system, substrate, etc. (the aforementioned light source and light receiving unit) of the absorptometer 44 or the scatterphotometer 45 .

[0117] (B) The second group and the middle level data alarms generally include (B-1) data alarms generated due to abnormal reaction process and (B-2) data alarms generated due to abnormal sample concentration. For example, the following data alarms can be cited. Figure 4 The corresponding table portion is shown in (B).

[0118] (B-1) Examples of data alarms generated due to abnormalities in the reaction process include a cell blank abnormal alarm B1, an absorbance difference normal alarm B2, a scattered light intensity difference normal alarm B3, and an alarm that cannot be calculated.

[0119] (1) The cell blank abnormality alarm B1 is a data alarm generated when the cell blank value measured before the analysis of the target component substance of the sample 2 deviates from the cell blank value stored in advance in the automatic analyzer 1, or deviates from the cell blank value of another reaction container used as a comparison object. In addition, the cell blank value is an optical measurement value in a state where the reaction solution 3 is not injected into the reaction container 25.

[0120] (2) Absorbance difference alarm B2 is a data alarm generated when the absorbance difference or absorbance change rate between specific measurement times during the reaction process of the target component substance measured by the absorptiometer 44 does not reach a predetermined threshold value set in advance, or exceeds the threshold value.

[0121] (3) The scattered light intensity difference alarm B3 is a data alarm generated when the scattered light intensity difference or the scattered light intensity change rate between specific measurement times during the reaction process of the target component material measured by the scattered light photometer 45 does not reach a predetermined threshold value set in advance, or exceeds the threshold value.

[0122] The data alarms generated due to abnormalities in these reaction processes are less likely to have abnormalities in the mechanism of the automatic analyzer 1, the sample 2, the reagent 4, etc., and therefore correspond to situations where automatic retesting can be performed without the user performing state improvement operations. Therefore, in this case, the automatic analyzer 1 performs automatic retesting by setting the same conditions as those in the previous measurement as retesting conditions as output control in order to obtain accurate measurement results.

[0123] (B-2) As alarms generated due to abnormal sample concentration, there are front band alarm B4, alarm B5 for exceeding the upper limit of the quantitative range, alarm B6 for excessive absorbance / scattered light intensity, alarm B6 for exceeding the lower limit of the quantitative range, repeated upper limit alarm, repeated lower limit alarm, etc.

[0124] (1) The front band alarm B4 is a data alarm generated when the amount of antigen or antibody in the test body 2 in the immunoassay is excessive. As a judgment method for this, there are the well-known reaction rate ratio method, antigen / antibody re-addition method, etc. In the reaction rate ratio method, the ratio of the absorbance change per unit time at the initial stage of the reaction (or the change in scattered light intensity) to the absorbance change (or the change in scattered light intensity) at the end of the reaction is calculated from the reaction process of the target component substance of the inspection item, and compared with the threshold value set in advance. In the antigen / antibody re-addition method, the antigen or antibody is additionally added after the reaction is completed, and the absorbance change or scattered light intensity change per unit time just after the addition is calculated and compared with the threshold value set in advance.

[0125] (2) The alarm B5 for exceeding the upper limit of the quantitative range is one of the alarms for exceeding the technical limit. It is a data alarm generated when the upper limit of the quantitative range set in advance for each type of photometer is exceeded. For example, when the concentration of the sample 2 in the reaction solution 3 is too high relative to the quantitative range of the photometer, this data alarm is generated. For example, in the above-mentioned Figure 3 In the case where the concentration of the sample 2 exceeds the upper limit value of the normal output range 301 during measurement by the absorptiophotometer 44, this data alarm is generated.

[0126] (3) The alarm B6 for exceeding the lower limit of the quantitative range is one of the alarms for exceeding the technical limit. It is a data alarm generated when the lower limit of the quantitative range of each photometer set in advance is exceeded. For example, when the concentration of the sample 2 in the reaction solution 3 is too low relative to the quantitative range of the photometer, this data alarm is generated. For example, in the above-mentioned Figure 3 In the case where the concentration of the sample 2 is measured by the absorptiophotometer 44 and is lower than the lower limit value of the normal output range 301, this data alarm is generated.

[0127] Usually, in the test body 2 that has generated an abnormality corresponding to the proband alarm B4, the target component substance is excessively contained, and because the concentration is high, the alarm B5 exceeding the upper limit of the quantitative range is also generated at the same time. Compared with the alarm B5 exceeding the upper limit of the quantitative range, the proband alarm B4 is generated when the target component substance is excessive. Therefore, when the automatic analyzer 1 generates these two data alarms at the same time, as an output control, only the proband alarm B4 is selected to be output. These data alarms correspond to the situation where automatic re-testing can be performed because there is no abnormality in the mechanism of the automatic analyzer 1, the test body 2, the reagent 4, etc.

[0128] When the pre-band alarm B4 or the alarm B5 of exceeding the upper limit of the quantitative range is generated, it indicates that the concentration of the target component substance in the sample 2 is too high. Therefore, the automatic analyzer 1 in this case sets the state of reducing the amount of the sample of the reaction solution 3 (or diluting the sample 2 with the reagent 4) as the re-measurement condition, and performs automatic re-testing. In addition, when the alarm B6 of exceeding the lower limit of the quantitative range is generated, it indicates that the concentration of the target component substance in the sample 2 is too low. Therefore, the automatic analyzer 1 in this case sets the state of increasing the amount of the sample of the reaction solution 3 as the re-measurement condition, and performs automatic re-testing.

[0129] (C) As the third group and low-level data alarm, for example, the following two can be cited. Figure 4 The corresponding table part is shown in (C). In this example, there are serum information alarm C1, reagent expiration alarm C2, and sample left over.

[0130] (1) The serum information alarm C1 is a data alarm generated when a coexisting substance that affects the analysis of the target component substance is mixed in the test body 2 such as blood. Coexisting substances include lipids, hemoglobin, bilirubin, etc. The test body 2 (also called abnormal test body) mixed with these coexisting substances is called chyle, hemolysis, and yellow. Hemolysis (also called red change) and yellow mainly affect the absorptiophotometer 44 because they cause the color change of the test body 2. Chyle mainly affects the scattering photometer 45 because it causes the turbidity change of the test body 2. Serum information is information about the above-mentioned coexisting substances. Serum information is usually determined separately from the analysis of the target component substance of the inspection item by using a reagent 4 that does not react with the test body 2 and using light of a wavelength corresponding to each coexisting substance to measure the absorbance of the test body 2 itself. The measured absorbances are compared with the threshold values ​​set in advance, and in the case where the threshold value is exceeded, the serum information alarm C1 is added.

[0131] (2) The reagent expiration date alarm C2 is a data alarm generated when the expiration date of the reagent 4 registered in the automatic analyzer 1 expires.

[0132] When these low-level data alarms are output, the measurement itself is normally completed and the measurement result can be obtained. Therefore, the automatic analyzer 1 processes the measurement result as a reference value and outputs it as output control. In addition, in this case, the condition can only be improved by replacing the sample 2 or the reagent 4. Therefore, the automatic analyzer 1 is set to not require automatic re-testing, and thus does not perform automatic re-testing.

[0133] In the output control function of the automatic analyzer 1, for each measurement of the two photometers, based on the detection of abnormality, the definition of the above-mentioned data alarm, and the predetermined judgment by the analysis control unit 50 (particularly the analysis unit 52), a selected basically one data alarm is added to the measurement result. The information with the data alarm added to the measurement result is temporarily stored in the data storage unit 55. At the same time, each unit such as the analysis judgment unit 56 refers to the information of the data storage unit 55 to perform output control.

[0134] In addition, depending on the type of abnormality, etc., there may be a situation where multiple data alarms become candidates for annotation for a measurement result of a photometer. In this case, in the automatic analysis device 1, based on the previous setting and predetermined judgment, one data alarm is selected for annotation. This setting is a design matter of the data alarm function. For example, as a definition of a data alarm in advance, the importance and priority are set between multiple data alarms (corresponding abnormalities, etc.). Figure 4Although not shown in the figure, for example, a priority number can be set for each data alarm. The analyzing unit 52 selects the data alarm with the highest priority among the multiple candidate data alarms. In addition, as a modified example, the automatic analysis device may not have the priority setting as described above, but may annotate multiple data alarms in one measurement result.

[0135] In the above description, several specific examples are given for the three levels of data alarms and the corresponding abnormalities, but the present invention is not limited thereto and can also be applied to other abnormalities and data alarms. Figure 4 The table also records examples of other types of data alarms without an identification code, which are not used in output control in the embodiment but can be used in other embodiments.

[0136] [Analysis and processing (1)]

[0137] Next, the output control processing corresponding to the combination of data alarms and the output control function of the automatic analyzer 1 will be described. First, as the first stage, the output control processing corresponding to the combination of data alarms and the output control function of the automatic analyzer 1 will be described. Figure 2 The analysis control unit 50 of the analysis control unit 50 performs analysis processing. The analysis control unit 50 performs analysis processing on the object sample 2 to which the analysis request has been received. At this time, the control unit 53 determines whether a simultaneous analysis request is set as the analysis request. When the simultaneous analysis request is set, the control unit 53 causes the measurement unit 51 and the analysis unit 52 to perform each analysis processing (absorption analysis and scattered light analysis) on the object sample 2 based on each measurement value (the aforementioned signal) obtained from the two photometers. When the simultaneous analysis request is not set but an analysis request for analysis by one of the two photometers ("absorption analysis" or "scattered light analysis" as "single analysis") is set, the control unit 53 causes the measurement unit 51 and the analysis unit 52 to perform analysis processing on the object sample 2 based on the measurement value of the corresponding photometer.

[0138] The measuring unit 51 measures the light quantity / light intensity of the target sample 2 based on the measured value or calculated value included in the signal from the photometer for each type of photometer. The measuring unit 51 obtains the light quantity / light intensity of the transmitted light of the reaction solution 3 of the reaction container 25 that obtains the measured value based on the measured value from the absorptometer 44. In addition, the measuring unit 51 obtains the light quantity / light intensity of the scattered light of the reaction solution 3 of the reaction container 25 that obtains the measured value based on the measured value from the scattered light meter 45. For example, the measuring unit 51 calculates the light intensity based on the light quantity of the transmitted light or scattered light as the measured value. Then, the measuring unit 51 stores the information of the light intensity in the data storage unit 55 as measurement data associated with the information of the target reaction container 25 into which the target sample 2 is dispensed or the analysis request information of the sample 2. In addition, in the measuring unit 51, other parameters may be measured and calculated, not limited to the light intensity. In addition, the measurement data includes information on the reaction process measured by the photometer (i.e., the measurement value at each measurement time, etc.). The analysis request information includes information on the target sample 2, the reagent 4, and the like.

[0139] The analyzing unit 52 refers to the information based on the measurement data of the measuring unit 51, analyzes the target component substance of the test body 2 in the object reaction solution 3, and obtains at least one of the concentration or the component amount ("concentration / component amount"). The analyzing unit 52 reads the light amount / light intensity of the transmitted light or the light amount / light intensity of the scattered light in the measurement data to obtain the concentration of the target component substance. For example, the analyzing unit 52 refers to the light intensity and also refers to the information of the calibration line to calculate the concentration of the target component substance based on the light intensity. At this time, the analyzing unit 52 uses the calibration line corresponding to the reagent 4 used in the reaction solution 3 prepared in advance to convert the light intensity into the concentration. When the absorptiophotometer 44 is used, the analyzing unit 52 uses the calibration line used by the absorptiophotometer 44 to convert the transmitted light intensity into the concentration of the target component substance. When the scatterophotometer 45 is used, the analyzing unit 52 uses the calibration line used by the scatterophotometer 45 to convert the scattered light intensity into the concentration of the target component substance.

[0140] The calibration curve represents the relationship between the concentration of each target component substance and the amount / intensity of transmitted or scattered light obtained using a test body containing a standard substance or the like having a known concentration of the target component substance. The calibration curve data of the reagent 4 in each reagent bottle 35 of the reagent disk 30 is stored in the data storage unit 55 in advance.

[0141] The analyzing unit 52 stores the concentration information obtained by the analysis in the data storage unit 55 as analysis data associated with the reaction container 25 of the target sample 2 or the information of the analysis request. In the embodiment, the concentration of the target component substance is mainly processed as the measurement result. In addition, the measurement result can also be called an analysis result, an analysis result, etc.

[0142] In addition, during the above analysis, the analysis unit 52 determines whether an abnormality, error, etc. occurred during the measurement of the object test body 2 based on the reaction process measured by each photometer, the analyzed concentration, and the analysis parameter information set in advance. Examples of such abnormalities are as described above. When the analysis unit 52 determines that an abnormality or the like occurred during the measurement, it annotates a data alarm corresponding to the type of the abnormality or the like in the measurement result including the concentration corresponding to the type of photometer, and stores these as analysis data in the data storage unit 55. When the analysis unit 52 annotates a data alarm, it annotates the data alarm according to the type of the abnormality or the like. Figure 4 The categories shown define the data that is selected and determined based on the predefined criteria.

[0143] The control unit 53 controls the parts including the sample disk 10, the sample dispensing mechanism 41, and each mechanism of each photometer, and monitors and determines the occurrence of abnormalities, errors, etc. in these parts during the analysis operation of the target sample 2. When the control unit 52 detects abnormalities, etc. in the mechanism, the control result information including information indicating the abnormalities, etc. is stored in the data storage unit 55. The analysis unit 52 refers to the measurement data and the control result information from the data storage unit 55. The analysis unit 52 determines the presence or absence of abnormalities, etc. during measurement and the type of the abnormalities, etc. based on the measurement data and the control result information.

[0144] As described above, as the first stage, data including the measurement results are stored in the data storage unit 55 as the analysis results based on the measurement unit 51, the analysis unit 52 and the control unit 53. In the case of abnormality during measurement, data with a data alarm attached to the measurement results can be obtained. In the case of simultaneous analysis, data is obtained separately for each type of photometer. And, as the second stage, the analysis control unit 50 performs output control processing for the analysis results of the object detection body 2 as follows. The analysis control unit 50 performs the processing of the second stage through the simultaneous analysis determination unit 56, the automatic re-inspection determination unit 57, the abnormality inspection unit 58 during measurement, the priority output determination unit 59 and the priority output error determination unit 60. The analysis control unit 50 uses these to output the analysis results to the display screen of the output unit 71.

[0145] [Analysis and processing (2)]

[0146] Next, refer to Figure 2The output control processing of the second stage will be described. In the case of simultaneous analysis, the analysis control unit 50 outputs the analysis data including the measurement results of each of the two photometers to the simultaneous analysis determination unit 56 via the data storage unit 55. The simultaneous analysis determination unit 56 refers to the analysis data from the data storage unit 55. In addition, the analysis control unit 50 causes the automatic re-test determination unit 57, the measurement abnormality inspection unit 58, the priority output determination unit 59, and the priority output error determination unit 60 to perform processing as needed.

[0147] When the analysis control unit 50 outputs the result of the simultaneous analysis to the user through the display screen of the output unit 71, the simultaneous analysis determination unit 56 selects the appropriate measurement result from the two measurement results based on the above-mentioned characteristics according to the concentration of the target component substance, etc. In addition, when one or more data alarms are attached to the two measurement results, the analysis control unit 50 performs output control processing for selecting the measurement results, data alarms, and automatic re-examination information to be output according to the combination of data alarms as described below.

[0148] [Correspondence table]

[0149] Figures 5 to 8 The following is a table showing the association between the combination of a plurality of data alarms for output control and the output in the automatic analysis device 1. In particular, the table showing the association with the aforementioned medium-level data alarm is shown. The analysis control unit 50 and the output control function perform output control processing in accordance with the provisions of the corresponding table. In the first embodiment, the output control processing is installed as a software program processing as in the processing flow described later. In addition, the corresponding table can be maintained as an installed table or the like (i.e., the table can be referred to for determination, etc.), or the table or the like can be omitted by being installed as a processing flow.

[0150] Figure 5 , as the first part in the correspondence table, a first example of the association between the combination of the above-mentioned medium-level data alarms and the output is shown. Figure 5(A) in particular represents a combination of data alarms generated due to an abnormality in the reaction process (B-1). The first column "Absorption" of the corresponding table shows a first data alarm related to a first measurement result using the absorption photometer 44. The second column "Scattering" shows a second data alarm related to a second measurement result using the scattering photometer 45. That is, the group of the first column and the second column represents a combination of two data alarms. In the third column "Output" of the corresponding table, the output content selected in the case of the combination of the first column and the second column particularly represents a selection regarding the measurement result. The fourth column "Re-test" of the corresponding table shows whether it is necessary (whether or not) to perform the selected one, i.e., an automatic re-test based on the automatic re-test function. The fifth column "Conditions" of the corresponding table shows the automatic re-test conditions (i.e., re-measurement conditions, etc.) when performing the selected one, i.e., an automatic re-test request.

[0151] exist Figure 5 In (A), the values ​​of the first column "absorption" and the second column "scattering" are calculated according to Figure 4 There are 1. "Absorbance difference normal" (B2) / "scattered light intensity difference normal" (B3), 2. "Cell blank abnormal" (B1), 3. "Cannot calculate". As a combination of these three values, there are 3×3=9 combinations. Here, the absorbance difference normal alarm B2 and the scattered light intensity difference normal alarm B3 are combined into one, but further combinations thereof can also be considered. For each row of each combination, the values ​​of the third column "output", the fourth column "re-test", and the fifth column "condition" are specified. As the value of the third column "output", there are three values: "absorbance" (value 1), "scattering" (value 2), and "priority" (value 3). "Absorbance" (value 1) indicates that the first measurement result and the first data alarm on the side of the absorbance photometer 44 are selected. "Scattering" (value 2) indicates that the second measurement result and the second data alarm on the side of the scattered light photometer 45 are selected. "Priority" (value 3) indicates that one of the two measurement results and data alarms is selected based on the judgment of the priority output setting. As the value of the fourth column "re-test", there are two values: "yes" (value 1) and "no" (value 2). "Yes" (value 1) indicates that automatic retesting is required (necessary). "No" (value 2) indicates that automatic retesting is not required (not necessary). As the value of the 5th column "Condition", there are three values: "Same" (value 1), "Decrease" (value 2), and "Increase" (value 3). "Same" (value 1) indicates the same conditions as the previous measurement (remeasurement conditions, etc.). "Decrease" (value 2) indicates a change to a condition in which the amount of test body 2 is reduced relative to the conditions at the time of the previous measurement. "Increase" (value 3) indicates a change to a condition in which the amount of test body 2 is increased relative to the conditions at the time of the previous measurement.

[0152] For example, in the combination (1-1) of the first row, the group of data alarms of "absorption"-"scattering" is "B2 / B3"-"B2 / B3", "output" = "priority" (value 3), "re-test" = "yes" (1), "condition" = "same" (value 1). In these cases, the analysis control unit 50 selects the measurement result of the photometer and the data alarm (B2 / B3) on one side according to the judgment of the priority output setting, and outputs them as automatic re-test information for requesting automatic re-test under the same conditions as the previous time. The same output is also performed in the combination of other rows.

[0153] Likewise, Figure 5 (B) in particular indicates a combination of data alarms generated due to abnormal concentration of the sample (B-2). Figure 5 In (B), as the values ​​of the first column "absorption" and the second column "scattering", according to Figure 4 , including 1. "Excessive absorbance·scattered light intensity", 2. "Prozone" (B4), 3. "Exceeding the upper limit of the quantitative range" (B5), and 4. "Exceeding the lower limit of the quantitative range" (B6). As a combination of these four values, there are 4×4=16 combinations.

[0154] As an example, from the fourth to the eighth row, the data alarm of "absorption" is the four combinations of the preceding band alarm B4, and the output selection is "output" = "absorption" (value 1), "re-test" = "yes" (value 1), and "condition" = "reduction" (value 2). In these cases, the analysis control unit 50 selects the first measurement result of the absorptiophotometer 44 and the second data alarm (B4) for output as automatic re-test information for requesting automatic re-testing under the condition of a reduction in amount relative to the previous condition. From the ninth to the twelfth row, there are four combinations of the data alarm of "absorption" being the alarm B5 exceeding the upper limit of the quantitative range, and the output selection is the same. From the thirteenth to the sixteenth row, there are four combinations of the data alarm of "absorption" being the alarm B6 exceeding the lower limit of the quantitative range. In the combinations of the thirteenth, fourteenth, and fifteenth rows, the output selection is "output" = "absorption" (value 1), "re-test" = "yes" (value 1), and "condition" = "increase" (value 3). In these cases, the analysis control unit 50 selects the first measurement result of the absorptometer 44 and the first data alarm (B6) to output as automatic re-test information for requesting automatic re-testing with a condition that increases the amount relative to the previous condition. In the combination of the sixteenth row, as output selections, "output" = "scattering" (value 2), "re-test" = "yes" (value 1), "condition" = "increment" (value 3). In this case, the analysis control unit 50 selects the second measurement result of the scatterometer 45 and the second data alarm (B6) to output as automatic re-test information for requesting automatic re-testing with a condition that increases the amount relative to the previous condition.

[0155] Figure 6 In the second part of the correspondence table, the combination of (B-1) reaction process abnormality and (B-2) sample concentration abnormality in the medium-level data alarm is shown. Here, as the values ​​of the first column "absorption" and the second column "scattering", there are 7 values ​​of the aforementioned "B2 / B3", "B1", "cannot be calculated", "absorbance·scattered light intensity excessive", "B4", "B5", and "B6".

[0156] As an example, from the first to the fourth row, there are four combinations of cases where the data alarm for "absorption" is (B-1) "B2 / B3" in the abnormal reaction process, and the data alarm for "scattering" is (B-2) abnormal detection body concentration. In the first to third rows, the output selections are "output" = "absorption" (value 1), "re-test" = "yes" (value 1), and "condition" = "same" (value 1). In the fourth row, the output selections are "output" = "scattering" (value 2), "re-test" = "yes" (1), and "condition" = "increment" (value 3). From the fifth to the eighth row, the data alarm (B-1) for "absorption" is "B1" in the abnormal reaction process, and the data alarm for "scattering" is (B-2) abnormal detection body concentration. The output selections are the same as the first to fourth rows.

[0157] In addition, for example, from the 16th to the 18th row, there are three combinations of the data alarm of "absorption" being (B-2) the front band alarm B4 in the abnormality of the detection body concentration, and the data alarm of "scattering" being (B-1) the abnormality of the reaction process. In the 16th to the 18th row, as output selection, "output" = "absorption" (value 1), "re-test" = "yes" (value 1), "condition" = "reduction" (value 2). In addition, for example, from the 19th to the 21st row, there are three combinations of the data alarm of "absorption" being (B-2) the alarm B5 of exceeding the upper limit of the quantitative range in the abnormality of the detection body concentration, and the data alarm of "scattering" being (B-1) the abnormality of the reaction process. In the 19th to the 21st row, as output selection, "output" = "absorption" (value 1), "re-test" = "yes" (value 1), "condition" = "reduction" (value 2). For example, from the 22nd to the 24th row, there are three combinations of the data alarm of "absorption" being (B-2) alarm B6 of exceeding the lower limit of the quantitative range in the abnormal concentration of the test body, and the data alarm of "scattering" being (B-1) abnormal reaction process. In the 22nd to 24th rows, as output selection, "output" = "absorption" (value 1), "retest" = "yes" (value 1), and "condition" = "increment" (value 3).

[0158] Figure 7In the third part of the corresponding table, a combination of data alarms for medium-level (B-1) abnormal reaction process and low-level data alarms is shown. Here, as the values ​​of the first column "Absorbance" and the second column "Scattering", there are six values ​​of the aforementioned "B2 / B3", "B1", "Uncalculated", "Serum Information (C1)", "Remaining Detector", and "Expired Reagent Validity Period (C2)".

[0159] As an example, from the first row to the fourth row, the data alarm for "absorption" is "B2 / B3" in the abnormal reaction process (B-1), and the data alarm for "scattering" is three combinations of three low levels. In the first row to the third row, the output selections are "output" = "scattering" (value 2), "re-test" = "none" (value 2), and "condition" = "-" (no value). In these cases, the analysis control unit 50 selects the second measurement result of the scattering photometer 45 and the second data alarm (low level) for output, and does not make an automatic re-test request. Similarly, the fourth row to the sixth row are the cases where the data alarm for "absorption" is "B4" and the data alarm for "scattering" is three combinations of three low levels. The same output selections are also used in these cases.

[0160] From the tenth to the twelfth rows, the data alarm for "absorbance" is a low-level serum information alarm (C1), and the data alarm for "scattering" is a combination of three types of abnormal reaction processes (B-1). In the tenth to twelfth rows, the output selections are "output" = "absorbance" (value 1), "re-test" = "none" (value 2), and "condition" = "-" (no value). In these cases, the analysis control unit 50 selects the first measurement result of the absorptiophotometer 44 and the first data alarm (low level) for output, and does not make an automatic re-test request. Similarly, the sixteenth to eighteenth rows are the data alarms for "absorbance" as the reagent expiration alarm C2, and the data alarms for "scattering" are a combination of three types of abnormal reaction processes (B-1). These cases are also the same output selections.

[0161] Figure 8 In the fourth part of the corresponding table, a combination of a data alarm of a medium-level (B-2) abnormal test body concentration and a low-level data alarm is shown. Here, as the values ​​of the first column "Absorbance" and the second column "Scattering", there are seven values ​​of the aforementioned "Absorbance·Scattered Light Intensity Excessive", "B4", "B5", "B6", "Serum Information (C1)", "Test Body Carryover", and "Reagent Expiration Date Expired (C2)".

[0162] As an example, from the first to the fourth row, the data alarm for "absorption" is (B-2) "excessive absorbance and scattered light intensity" in the abnormal concentration of the test body, and the data alarm for "scattering" is three combinations of three low-level ones. In the first to third rows, the output selections are "output" = "absorption" (value 1), "re-test" = "yes" (value 1), and "condition" = "reduction" (value 2). Similarly, the fourth to sixth rows are the cases where the data alarm for "absorption" is "B4" and the data alarm for "scattering" is three combinations of three low-level ones. The same output selections are also used in these cases. Similarly, the seventh to ninth rows are the cases where the data alarm for "absorption" is "B5" and the data alarm for "scattering" is three combinations of three low-level ones. The same output selections are also used in these cases. Similarly, the tenth to twelfth rows are the cases where the data alarm for "absorption" is "B6" and the data alarm for "scattering" is three combinations of three low-level ones. In these cases, the output selections are "Output" = "Scattering" (value 2), "Recheck" = "None" (value 2), and "Condition" = "-".

[0163] From the thirteenth to the sixteenth row, there are four combinations of the data alarm of "absorbance" being a low-level serum information alarm C1, and the data alarm of "scattering" being (B-2) four types of abnormal test body concentration. In the thirteenth to fifteenth rows, the output selections are "output" = "absorbance" (value 1), "re-test" = "no" (value 2), and "condition" = "-". In the sixteenth row, the output selections are "output" = "scattering" (value 2), "re-test" = "yes" (value 1), and "condition" = "increment" (value 3). Similarly, in the combination from the seventeenth to the twentieth row, the same output selections are made. Similarly, in the combination from the twenty-first to the twenty-fourth row, the data alarm of "absorbance" is a low-level reagent expiration alarm C2, which is the same output selection.

[0164] [Processing Flow]

[0165] Next, refer to Figures 9 to 14 , the flow of the output control process performed by the analysis control unit 50 of the automatic analyzer 1 is described.

[0166] [(1) Output control processing]

[0167] Fig. 9 This is a flow chart showing the first processing of the analysis control unit 50. This first processing represents an output control process for selecting the measurement results and data alarms to be output using one or both of the two photometers. This flow chart has steps S201 to S210. The following will be described in the order of the steps. In addition, Fig. 9The following multiple processing flows are divided into multiple flow charts for illustration and description. These processing flows are logically connected between steps and can be understood as a processing flow as a whole. That is, it can also be realized by analyzing the entire CPU of the control unit 50 as a program process.

[0168] (S201) The simultaneous analysis determination unit 56 confirms whether the form of the analysis request for the object detection body 2 is a simultaneous analysis request. In the case of a simultaneous analysis request (yes), enter S204, and in the case of not a simultaneous analysis request (no), enter S202. In addition, the so-called case of not a simultaneous analysis request corresponds to a case where a single analysis request (absorption analysis request or scattered light analysis request) is set to be performed by one of the absorptometer 44 or the scattered light photometer 45. There may also be other forms of analysis requests. For example, it may be a "simultaneous analysis of 2 items by absorption" request. "Simultaneous analysis of 2 items by absorption" uses only the absorptometer 44 to simultaneously measure and analyze two target component substances in the reaction solution 3 in the reaction container 25 of the same object detection body 2.

[0169] (S202) In the case of a single analysis request, the simultaneous analysis determination unit 56 causes the output unit 71 to output all data (including measurement results and data alarms) measured by the requested party's photometer. Thus, the concentration as the measurement result and the data alarm attached when there is an abnormality during measurement are displayed on the display screen of the output unit 71 as the result of the single analysis.

[0170] (S203) Furthermore, in the automatic re-examination determination unit 57, for the measurement result of a single analysis, it is determined whether an automatic re-examination is necessary based on abnormalities during measurement, etc. The automatic re-examination determination unit 57 determines that an automatic re-examination is not necessary when no data alarm is annotated in the measurement result or when a high-level or low-level data alarm is annotated. When it is not necessary (No), no automatic re-examination request is made, and this process ends. When a medium-level data alarm is annotated in the measurement result, the automatic re-examination determination unit 57 determines that an automatic re-examination is necessary. In such a case (necessary), the process proceeds to S210.

[0171] (S210) The automatic reinspection determination unit 57 performs an automatic reinspection request with an automatic reinspection condition corresponding to the type of the data alarm. That is, the automatic reinspection determination unit 57 stores automatic reinspection request information including the re-measurement condition, etc. in the data storage unit 55. The automatic reinspection function of the analysis control unit 50 controls the automatic reinspection based on the automatic reinspection request information.

[0172] On the other hand, when a simultaneous analysis request is made in S201, the simultaneous analysis determination unit 56 outputs all data including both the first measurement result using the absorptiophotometer 44 and the second measurement result using the scatterophotometer 45 for the target sample 2 for which the request is made, via the measurement abnormality inspection unit 58. All the above data are stored in the data storage unit 55 through the measurement unit 53 and the analysis unit 52 described above.

[0173] (S204) The measurement abnormality check unit 58 determines whether a data alarm is attached to the first measurement result and the second measurement result, which are the measurement results of the two photometers. That is, the measurement abnormality check unit 58 checks whether an abnormality during measurement, etc., indicated by a data alarm, has occurred in each measurement result. As a result of this determination, if an abnormality, etc. exists only in the first measurement result (A), the process proceeds to S207, and if an abnormality, etc. exists only in the second measurement result (B), the process proceeds to S209. In addition, if an abnormality, etc. exists in both the first measurement result and the second measurement result (C), the process proceeds to S205 ( Figure 3 ). In addition, as a result of the determination, when both the first measurement result and the second measurement result have no abnormality or the like (D), the process proceeds to S206.

[0174] (S207) The abnormality check unit 58 outputs all data related to the scattered light analysis including the second measurement result to the output unit 71. Thus, on the display screen of the output unit 71, data indicating no abnormality including the concentration obtained by the scattered light meter 45 is preferentially output to the user as the result of the simultaneous analysis.

[0175] (S209) The abnormality check unit 58 outputs all data related to the absorbance analysis including the first measurement result to the output unit 71. Thus, data including the concentration obtained by the absorptiophotometer 44 showing no abnormality is preferentially output to the user on the display screen of the output unit 71.

[0176] (S205) The priority output alarm determination unit 60 performs the following ( Fig.10 ) is a priority output alarm determination process. This process is, in outline, a process for determining which data alarm is to be outputted with priority, between a first data alarm appended to a first measurement result and a second data alarm appended to a second measurement result.

[0177] (S206) The priority output determination unit 59 performs a priority output determination process on the measurement results of the two photometers, namely, the first measurement result and the second measurement result. This process is a process for determining which measurement result is preferentially selected to be output among the measurement results of the two photometers. When making this determination, the priority output determination unit 59 refers to the priority output setting information set in advance for the analysis request from the data storage unit 55. For example, the priority output setting information is set as one of the parameters of the analysis request information. The priority output setting information, for example, includes a setting value of a priority output rank, and the setting value of the priority output rank indicates which of the first measurement result and the second measurement result is preferentially output. For example, as the priority output rank, a value of 1 indicates a setting of preferentially outputting the first measurement result ("absorption priority setting"), and a value of 2 indicates a setting of preferentially outputting the second measurement result ("scattering priority setting"). Any priority setting basically outputs only one measurement result of the photometer. The priority output determination unit 59 selects one of the first measurement result and the second measurement result according to the priority output setting information of the analysis request information.

[0178] In S206, when the priority output setting function is turned on, in the case of "scattering priority setting" (A), the process proceeds to S207, and in the case of "absorption priority setting" (B), the process proceeds to S209. In addition, when the priority output setting function is turned off, that is, when there is no priority output setting between the two photometers (C), the process proceeds to S208.

[0179] (S207) Priority output determination unit 59 causes output unit 71 to output all data including the second measurement result of scatterphotometer 45. Thus, on the display screen of output unit 71, all data including the second measurement result indicating no abnormality is output to the user with priority.

[0180] (S209) The priority output determination unit 59 causes the output unit 71 to output all data including the first measurement result of the absorptiometer 44. Thus, on the display screen of the output unit 71, all data including the first measurement result indicating no abnormality is output to the user with priority.

[0181] (S208) The priority output determination unit 59 causes the output unit 71 to output all data including both the first measurement result and the second measurement result. Thus, all data including the absence of abnormality in the measurement results of the two photometers is output to the user on the display screen of the output unit 71. After S207, S208 or S209, this flow ends.

[0182] [(2) Priority output alarm determination processing]

[0183] Next, use Fig.10 The following figure shows Fig. 9The content of the priority output alarm determination process of step S205. Fig.10 The flow chart of the data alarm level classification determination process as the first process in the priority output alarm determination process performed by the priority output alarm determination unit 60 in S205 is shown. In this process, for the data alarms accompanying the measurement results of the two photometers, it is determined which classification the data alarms belong to based on the aforementioned group and level classification definitions. This flow chart includes steps S301 to S305. The following will be described in the order of the steps.

[0184] (S301) The priority output alarm determination unit 60 refers to two data alarms, namely, the first data alarm annotated in the first measurement result of the absorptometer 44 and the second data alarm annotated in the second measurement result of the scatterphotometer 45. The priority output alarm determination unit 60 determines whether the data alarm of the third group and the high level is included in one or both of the two data alarms. If included (yes), the process proceeds to S302, and if not included (no), the process proceeds to S303.

[0185] (S302) The priority output alarm determination unit 60 performs the following ( Fig.11 )’s high-level data alarm processing, after which this process ends.

[0186] (S303) The priority output alarm determination unit 60 determines whether one or both of the two data alarms include the second group and the medium level data alarm. If included (Yes), the process proceeds to S304, and if not included (No), the process proceeds to S305.

[0187] (S304) The priority output alarm determination unit 60 performs the following ( Fig.12 , Fig.13 )’s medium-level data alarm processing, after which this process ends.

[0188] (S305) In the above S303, the case of not containing (No) is equivalent to the case of not containing the third group and the low-level data alarm. In S305, the priority output alarm determination unit 60 executes the following ( Fig.14 )'s low-level alarm processing.

[0189] [(3) High-level data alarm processing]

[0190] Fig.11 This shows the flow of the high-level data alarm processing in S302 described above. Fig.11 The process includes steps S401 to S405. The following describes the process in order of the steps.

[0191] (S401) The priority output alarm determination unit 60 checks whether a high-level data alarm is attached to both the first measurement result and the second measurement result, in other words, checks whether both the first data alarm and the second data alarm are high-level data alarms. If both are high-level (yes), the process proceeds to S402, and if not (no), the process proceeds to S403.

[0192] (S402) The alarm determination unit 60 is given priority as an output, and the output unit 71 is made to output the higher-level data alarm of both the first data alarm and the second data alarm, and this flow is terminated.

[0193] (S403) The priority output alarm determination unit 60 checks whether one of the first data alarm and the second data alarm, for example, the first data alarm of the light absorption side, is a high-level data alarm. If the first data alarm is a high-level (Yes), the priority output alarm determination unit 60 proceeds to S404, and if not (No), proceeds to S405.

[0194] ( S404 ) The priority output alarm determination unit 60 causes the output unit 71 to output the first measurement result and the first data alarm on the absorption side, and ends this flow.

[0195] (S405) The process proceeds to S405 when the second data alarm annotated in the second measurement result of the scattering side is a high-level data alarm. Therefore, in S405, the priority output alarm determination unit 60 causes the output unit 71 to output the second measurement result and the second data alarm, and the process ends.

[0196] Regarding the above processing, when a high-level data alarm is generated, the measurement is failed and the measurement result is often not obtained. Therefore, in this case, as output control, the concentration of the measurement result, etc. can be output without outputting the data alarm. When the measurement result is obtained, the measurement result and the data alarm can be output.

[0197] In addition, as mentioned above, high-level data alarms are annotated when the user needs to perform improvement operations on the state of the mechanism, the sample 2, the reagent 4, etc. for abnormalities. Therefore, as mentioned above, in the case where high-level data alarms are annotated in the measurement results of both parties, as shown in S402, it is preferred to output all of these data alarms to call the user's attention and urge him to perform improvement operations. In addition, at this time, the aforementioned system alarm and data alarm can be output simultaneously.

[0198] [(4) Medium-level alarm processing]

[0199] Fig.12 , Fig.13The above-mentioned S304 shows the medium-level data alarm processing. This processing can be performed in the following cases: (a) when both the first data alarm and the second data alarm are medium-level, (b) when only the first data alarm is medium-level, and (c) when only the second data alarm is medium-level. Fig.12 Indicates the portion from step S501 to step S508. Fig.13 As Fig.12 Continuation of step S509 to step S520 is shown.

[0200] (S501) The priority output alarm determination unit 60 further determines the detailed category of the first data alarm annotated in the first measurement result of the absorptometer 44 and the second data alarm annotated in the second measurement result of the scatter photometer 45 based on the aforementioned classification definition. In S501, the priority output alarm determination unit 60 determines whether the first data alarm on the absorbance side is a data alarm generated due to the high concentration of the test body 2. As a data alarm of this category, it is equivalent to the aforementioned front band alarm B1, the alarm B2 exceeding the upper limit of the quantitative range, etc. If it is a data alarm of this category (yes), enter S502, and if it is not (no), enter S504.

[0201] (S502, S503) In S502, the priority output alarm determination unit 60 causes the output unit 71 to output the first measurement result and the first data alarm. In addition, in S503, the priority output alarm determination unit 60 stores automatic retest request information in the data storage unit 55, in which the automatic retest request information is set to require automatic retesting using the absorptiophotometer 44 and to set a condition of reducing the sample volume of the reaction container 25 of the target sample 2. The analysis control unit 50 performs automatic retesting under the conditions according to the automatic retest request information, stores the result, and causes the output unit 71 to output it. After S503, this process ends.

[0202] In the case of S501 to S503 above, the following judgment and output control are performed. In the case where the concentration of the target component substance of the test body 2 is determined to be too high in the first measurement result using the absorptometer 44 suitable for the measurement of high-concentration components, the reliability of the second measurement result of the scattering photometer 45 suitable for the measurement of low-concentration components is also low. Therefore, as shown in S502, only the first measurement result of the absorption side and the first data alarm are output, and as shown in S503, automatic re-testing is performed under the condition of reduced quantity. Thus, an attempt is made to make the measurement result during re-testing fall within the appropriate quantitative range (the normal output range mentioned above) of the absorptometer 44.

[0203] (S504) The priority output alarm determination unit 60 determines whether the second data alarm on the scattering side is a data alarm generated due to low concentration of the sample 2. This type of data alarm is equivalent to the alarm B3 of exceeding the lower limit of the quantitative range described above. If it is a data alarm of this type (Yes), the process proceeds to S505, and if it is not (No), the process proceeds to S507.

[0204] (S505, S506) In S505, the priority output alarm determination unit 60 causes the output unit 71 to output the second measurement result and the second data alarm on the scattering side. In addition, in S506, the priority output alarm determination unit 60 stores the automatic re-test request information in the data storage unit 55, in which the automatic re-test request information is set as the condition that the automatic re-test using the scattering photometer 45 is required and the test volume of the reaction container 25 of the target test object 2 is increased. The analysis control unit 50 performs the automatic re-test under the condition according to the automatic re-test request information, stores the result, and causes the output unit 71 to output it. After S506, this process ends.

[0205] In the case of S504 to S506, the following determination and output control are performed. In the case where the concentration of the target component substance of the test body 2 is determined to be too low in the second measurement result using the scattering photometer 45 suitable for the measurement of low-concentration components, the reliability of the first measurement result in the absorptometer 44 suitable for the measurement of high-concentration components is low. Therefore, as shown in S505, only the second measurement result and the second data alarm on the scattering side are output, and as shown in S506, automatic re-testing is performed under the condition of increment. Thus, an attempt is made to make the measurement result during re-testing fall within the appropriate quantitative range of the scattering photometer 45 or the absorptometer 44.

[0206] (S507) The priority output alarm determination unit 60 determines whether the second data alarm of the second measurement result of the scattering side is a low-level data alarm. This type of data alarm is equivalent to the aforementioned serum information alarm C1, etc. If it is a low level (yes), proceed to S508. If not (no), proceed to S509 ( Fig.13 ).

[0207] (S508) The priority output alarm determination unit 60 causes the output unit 71 to output the second measurement result and the second data alarm on the scattering side. In this case, the second measurement result is output as a reference value, and automatic rechecking is not required, and this flow ends.

[0208] In the case of S508 above, as a combination of two data alarms, it is consistent with the state that a data alarm caused by an abnormal reaction process or a data alarm caused by a low concentration of the test body 2 is annotated in the first measurement result, and a low-level data alarm is annotated in the second measurement result. In this combination, at least one of the test body 2 or the reagent 4 used in the measurement has a reason for generating a low-level data alarm. In addition, in this combination, the concentration of the target component substance of the test body 2 is lower than the lower limit of the quantitative range of the absorptometer 44. Therefore, the scattering photometer 45 can be quantified, but the concentration is low for the absorptometer 44 and cannot be quantified. It is considered that as a result, this combination is generated. That is, in the case of this combination, it can be judged that the measurement itself using the scattering photometer 45 is carried out normally. Therefore, in this case, it is set to output the second measurement result of the scattering side as a reference value, and no automatic re-test is performed.

[0209] (S509) Fig.13 In S509, the priority output alarm determination unit 60 determines whether the second data alarm of the second measurement result using the scattered photometer 45 is an alarm caused by the high concentration of the sample 2. If it is a data alarm of this type (yes), the process proceeds to S510, and if not (no), the process proceeds to S513.

[0210] ( S510 ) The priority output alarm determination unit 60 causes the output unit 71 to output the first measurement result using the absorptiometer 44 and the first data alarm.

[0211] (S511) Furthermore, the priority output alarm determination unit 60 determines whether the first data alarm is an alarm caused by an abnormality in the reaction process. If it is a data alarm of this type (Yes), the process proceeds to S516, and if not (No), the process proceeds to S512.

[0212] (S516) The priority output alarm determination unit 60 stores the automatic retest request information in the data storage unit 55, in which the automatic retest request information is set to require automatic retest and is set to the same condition as the previous condition when the abnormality indicated by the first data alarm (i.e., the abnormality in the reaction process, etc.) was generated. In the case of S516, as a combination of data alarms, the data alarm generated due to the abnormality in the reaction process is annotated in the first measurement result, and the data alarm generated due to the high concentration of the sample 2 is annotated in the second measurement result. In this case, the concentration of the target component substance of the sample 2 exceeds the upper limit of the quantitative range of the scatter photometer 45, and it can be determined that the measurement by the absorptometer 44 has failed. Therefore, in this case, the retest is performed under the same conditions as the previous time. The automatic analyzer 1 confirms the result of the automatic retest whether the concentration of the target component substance of the sample 2 is within the quantitative range of the absorptometer 44. At this time, if the automatic retest is performed under the condition of reducing the amount of the sample, it is possible that it is lower than the quantitative range of the scatter photometer 45. Therefore, the automatic retest is performed under the same conditions as the previous time. After S516, this process ends.

[0213] (S512) When entering S512, the alarm determination unit 60 outputs the first data alarm on the absorbance side first, and determines whether it is an alarm caused by low concentration of the sample 2. If it is a data alarm of this type (yes), enter S506, if not (no), there is no need to perform automatic re-test, and this process ends.

[0214] When entering S506 from S512, the automatic retest is performed under the condition of increasing the amount of the test volume as described above. In this case, the combination of data alarms corresponds to the state that the second measurement result exceeds the upper limit of the quantitative range of the scattering photometer 45, and the first measurement result is less than the lower limit of the quantitative range of the absorptiophotometer 44. In this case, the possibility of failure of the measurement of both photometers is high. Therefore, as described above, the retest is performed under the same conditions to try to obtain a normal result.

[0215] In the above S512, if it is not the case (No), the automatic re-test is not performed and the test is terminated. At this time, as a combination of data alarms, it corresponds to the state in which a data alarm caused by the high concentration of the test body 2 is annotated in the second measurement result, and a low-level data alarm is annotated in the first measurement result. This combination corresponds to the situation in which at least one of the test body 2 or the reagent 4 used in the measurement has the cause of generating a low-level data alarm. In addition, this combination corresponds to the situation in which the concentration of the target component substance of the test body 2 exceeds the upper limit of the quantitative range of the scattering photometer 45, so that it cannot be quantified by the scattering photometer 45, but can be quantified by the absorption photometer 44. Therefore, it is considered that this combination has been generated. That is, in the case of this combination, it can be determined that the measurement was performed normally in the first measurement result. Therefore, in this case, it is set to output the first measurement result of the absorption side as a reference value, and no automatic re-test is performed.

[0216] (S513) The priority output alarm determination unit 60 determines whether the first data alarm of the light absorption side is a data alarm caused by abnormal reaction process. If it is a data alarm of this type (Yes), the process proceeds to S514, and if not (No), the process proceeds to S518.

[0217] (S514) The priority output alarm determination unit 60 selects the measurement result and data alarm of one side of the two measurement results and data alarms for priority output and outputs them according to the "priority output setting" set as a parameter in advance. At this time, the priority output alarm determination unit 60 makes a determination with reference to the setting value of the aforementioned priority output setting information. In the case where the setting value is a value indicating the "absorption priority setting" (A), enter S515, and in the case where the setting value is a value indicating the "scattering priority setting" (B), enter S517. As mentioned above, in the "absorption priority setting", the absorbance photometer 44 is set as a photometer with a higher priority output ranking than the scattering photometer 45. In the "scattering priority setting", the opposite priority output ranking is set.

[0218] (S515) The priority output alarm determination unit 60 selects the first measurement result and the first data alarm of the absorptiometer 44 according to the "absorption priority setting" and causes the output unit 71 to output them. After S515, the process proceeds to S516.

[0219] (S517) The priority output alarm determination unit 60 selects the second measurement result and the second data alarm of the scatter photometer 45 according to the "scatter priority setting" and causes the output unit 71 to output them. After S517, the process proceeds to S516.

[0220] (S516) After S515 or S517, in S516, the priority output alarm determination unit 60 sets the automatic retest as necessary and makes an automatic retest request under the same conditions as the previous time. That is, the priority output alarm determination unit 60 stores the automatic retest request information in the data storage unit 55, which is set to the same retest conditions as the conditions when the abnormality indicated by the data alarm occurs.

[0221] The combination of data alarms in the above-mentioned S513 to S517 corresponds to a state in which both the first measurement result and the second measurement result are respectively annotated with data alarms caused by abnormal reaction processes. In this case, it can be determined that the measurements of both photometers have failed. Therefore, in this case, basically, the measurement results and data alarms of either photometer can be output. Therefore, in the above-mentioned processing example, based on the judgment of "priority output setting" in S514, the measurement results and data alarms of one side are selected, and in S516, an automatic re-test is performed under the same conditions as the previous time to try to obtain normal results.

[0222] (S518, S519) In S518, the priority output alarm determination unit 60 causes the output unit 71 to output the first measurement result and the first data alarm on the absorbance side. In addition, in S519, the priority output alarm determination unit 60 determines whether the first data alarm is an alarm caused by the low concentration of the sample 2. If it is a data alarm of this type (yes), the process proceeds to S520. If not (no), the process ends without performing automatic re-testing.

[0223] ( S520 ) The priority output alarm determination unit 60 stores the automatic reinspection request information under the condition of increasing the detection volume in the data storage unit 55 , and performs automatic reinspection.

[0224] In the combination of data alarms in the above-mentioned S518 to S520, it is consistent with the state that the data alarm generated due to abnormal reaction process is attached to the second measurement result, and the data alarm generated due to low concentration of the sample 2 is attached to the first measurement result. In this case, it can be determined that the measurement by the scattering photometer 45 has failed. Therefore, in S519, the first measurement result and the first data alarm on the absorbance side are output, and an automatic re-test is performed in S520. Thus, an attempt is made to make the measurement result at the time of automatic re-test fall within the quantitative range of the absorptiophotometer 44.

[0225] In the above S519, if it is not the case (No), when the automatic re-test is not performed and the process ends, the combination of data alarms corresponds to a state in which a data alarm due to abnormal reaction process is annotated in the second measurement result and a low-level data alarm is annotated in the first measurement result. In this case, it can be determined that the measurement by the scattering photometer 45 has failed, and the measurement by the absorptiophotometer 44 itself has ended normally. Therefore, in this case, the first measurement result is output as a reference value in S519, the first data alarm is output, and the automatic re-test is not performed.

[0226] [(5) Low-level alarm processing]

[0227] Fig.14 This shows the low-level data alarm processing of the above-mentioned S305. Fig.14 The process includes steps S601 to S607. The following describes the process in order of the steps.

[0228] (S601) The priority output alarm determination unit 60 checks whether both the first data alarm annotated in the first measurement result of the absorptometer 44 and the second data alarm annotated in the second measurement result of the scatterphotometer 45 are low-level data alarms. If both are low-level (yes), the process proceeds to S602, and if not (no), the process proceeds to S605.

[0229] (S602) The priority output alarm determination unit 60 performs a priority output determination based on the "priority output setting" and selects the measurement result and data alarm of the priority output side for output. The priority output alarm determination unit 60 proceeds to S603 when it is "scattering priority output" (B), and proceeds to S604 when it is "absorption priority output" (A).

[0230] (S603) The priority output alarm determination unit 60 selects the second measurement result and the second data alarm based on the "scattering priority output" and outputs them to the output unit 71. After that, the automatic re-examination is not performed and this flow ends.

[0231] (S604) The priority output alarm determination unit 60 selects the first measurement result and the first data alarm based on the "absorption priority output" and outputs them to the output unit 71. After that, the automatic re-check is not performed and this flow ends.

[0232] (S605) The priority output alarm determination unit 60 checks whether only the first data alarm on the absorption side is at a low level. If only the first data alarm is at a low level (yes), the process proceeds to S606. If not (no), that is, only the second data alarm on the scattering side is at a low level, the process proceeds to S607.

[0233] (S606) The priority output alarm determination unit 60 selects the first measurement result and the first data alarm on the light absorption side, and outputs them to the output unit 71. After that, the automatic re-check is not performed, and this flow ends.

[0234] (S607) The priority output alarm determination unit 60 selects the second measurement result and the second data alarm on the scattering side, and outputs them to the output unit 71. After that, the automatic re-examination is not performed, and this flow ends.

[0235] As described above, in the case of each combination including a low-level data alarm, it can be determined that the measurement itself has been normally completed, so the measurement result is output as a reference value and automatic recheck is not performed.

[0236] [Effects, etc.]

[0237] As described above, the automatic analyzer 1 of the first embodiment is equipped with two photometers, namely, the absorption photometer 44 and the scattering photometer 45, and performs simultaneous analysis using the two photometers for the target component substances of each inspection item. The automatic analyzer 1 refers to two data alarms that may be attached to the two measurement results. In addition, when both sides of the two measurement results have two data alarms generated due to abnormalities during measurement, the automatic analyzer 1 selects the appropriate measurement results and data alarms to be output according to the combination of these data alarms. In this way, even if there are abnormalities during measurement using two photometers, the automatic analyzer 1 will perform output control in a manner that limits and reduces the amount of information output of the analysis results for the user. Therefore, according to the automatic analyzer 1, compared with the prior art example, accurate analysis results can be obtained in the simultaneous analysis, and even if there are abnormalities during measurement, the burden of judgment, operation, etc. on the output of the analysis results by the user can be reduced. As a user, when seeing the output of the analysis results on the display screen, since the information of the appropriate measurement results and data alarms has been automatically selected and limited, it is easy to identify and judge the status and easy to perform the response operation. Therefore, it is possible to prevent the user from making an erroneous judgment and to prevent a delay in the result report.

[0238] In addition, even if an abnormality occurs when two photometers are used for measurement, the automatic analyzer 1 will automatically perform appropriate automatic retest control based on the combination of data alarms. Even if an abnormality occurs in both of the two measurements, the automatic analyzer 1 will determine whether automatic retesting and conditions are required in a manner that reflects at least one of the device status or the test body composition status. The automatic analyzer 1 determines whether appropriate automatic retesting and conditions are required based on the combination, controls the automatic retesting, and controls the result. As a result, the automatic retesting function of the automatic analyzer 1 can be effectively utilized, and more accurate results (concentration, etc.) can be obtained in a shorter time through automatic retesting, which can prevent delays in result reporting caused by the user.

[0239] [Modification (1)]

[0240] The following example is a variation of the automatic analyzer 1 of embodiment 1. In embodiment 1, a case where two photometers of two types are provided is described, but it is not limited thereto, and it can also be applied to a case where three or more photometers of three types are provided. In addition, it can also be applied to a case where multiple photometers of a certain type are provided. For example, in the case where three photometers are provided, simultaneous analysis using the three photometers can be performed. Alternatively, simultaneous analysis using two photometers selected according to the setting and analysis request can also be performed among the three. Corresponding to the combination of multiple data alarms annotated in these multiple measurement results, output selection control can be performed in the same manner.

[0241] [Variation (2)]

[0242] In the first embodiment, it is described that data alarms corresponding to abnormalities are roughly classified into three groups and levels, and different output controls are performed according to these combinations. The classification of the above data alarms is not limited to three. As shown in the corresponding representation, as long as the combination of data alarms about the measurement results of multiple photometers is provided, there is a structure of association of output selection including measurement results and data alarms.

[0243] [Variation (3)]

[0244] In the first embodiment, when a combination occurs in which no matter which of the two measurement results and data alarms is output, the impact on the user is small and there is no particular problem, one of the information is selected and output based on the "priority output setting". However, this is not limited to this, and as a modified example, it is also possible to set a method in which the "priority output setting" is not used in the case of the specific combination as described above. In this modified example, based on the fixed setting in the installation, in the case of the specific combination as described above, only the specified one of the information is output, or the information of both is output.

[0245] [Variation (4)]

[0246] In the aforementioned flowcharts, an example of the processing order in the output control process is shown, but it is not limited to this. For example, it is obviously possible to set the processing flow structure to change the order of category determination of each level, abnormality, etc. As a modified example of the processing flow structure of embodiment 1, the following structure is also possible. Fig.12 In step S507 of the medium-level data alarm processing, before entering step S508 by judging the result (yes), the following step S507-1 is set. In this step S507-1, it is judged whether a low-level data alarm is attached to the first measurement result of the absorbance side. If there is an attachment (yes), enter Fig.14 In step S601, if it is not (No), proceed to step S508. That is, in the case of this process structure, the medium-level data alarm processing and the low-level data alarm processing are implemented as one flowchart. In this case, Fig.10 In the processing flow, only the judgment related to the high level of S301 is performed. If the high level is included in S301 (yes), the high level data alarm processing of S302 is performed, and if the high level is not included (no), the processing flow in which the above-mentioned medium level and low level processing are integrated is performed.

[0247] (Implementation Method 2)

[0248] use Fig.15 , an automatic analyzer according to Embodiment 2 of the present invention will be described. The basic structure of Embodiment 2 and the like is the same as that of Embodiment 1, and the components of Embodiment 2 and the like that are different from those of Embodiment 1 will be described below.

[0249] [Processing Flow]

[0250] In the first embodiment, data alarms related to multiple (two) photometers are classified into the three groups and levels mentioned above. For the middle level, it is further classified into (B-1) data alarms generated due to abnormal reaction process and (B-2) data alarms generated due to abnormal concentration of the test body. In addition, data alarms generated due to abnormal concentration of the test body are classified into data alarms generated due to high concentration and data alarms generated due to low concentration. And, as Figure 5 As shown in the figure, the output is selected according to the combination of data alarms.

[0251] In the second embodiment, it is not necessary to classify the data alarms (corresponding abnormalities, errors, etc.) related to multiple (two) photometers into the aforementioned groups and levels, as long as the multiple individual data alarms that may be generated are mastered. In the automatic analysis device of the second embodiment, in the processing flow, the individual data alarms annotated in the measurement results using each photometer are referred to, and the output is directly selected according to the combination of these data alarms. In the second embodiment, similarly to the example of the aforementioned correspondence table, the association between the combination of data alarms and the output is pre-defined. Based on this provision, the processing flow in the second embodiment is installed. The analysis control unit 50 refers to the two measurement results and data such as data alarms stored in the data storage unit 55 as the processing results of the analysis unit 52. In the processing flow, the analysis control unit 50 determines the combination of the referenced data alarms, and selects the measurement results, data alarms, and automatic re-examination information as outputs that can be associated according to the combination.

[0252] Compared with the processing flow structure of the first embodiment, the processing flow structure of the second embodiment is Fig. 9 The content of the priority output alarm determination process of step S205 ( Fig.10 etc.) are different. Fig.15 FIG. 2 shows a part of a processing flow configuration example in the automatic analyzer 1 according to the second embodiment. In the automatic analyzer 1, when performing output control processing for simultaneous analysis using two photometers, the following is performed: Fig.15 The process shown in the figure is used to replace the above Fig.10 etc. Fig.15 In the process of, the analysis control unit 50, for example, first, in step S151, determines whether the above-mentioned insufficient sample alarm A1 is annotated as the first data alarm in the first measurement result of the absorptometer 44. If there is an annotation (yes), proceed to S152, and if there is no annotation (no), proceed to other steps (omitted). In S152, the analysis control unit 50 determines whether the insufficient sample alarm A1 is annotated as the second data alarm in the second measurement result using the scatter photometer 45. If there is an annotation (yes), proceed to S153, and if there is no annotation (no), proceed to S154. The so-called case of an annotation in S152 (yes) is a case where both sides are insufficient sample alarm A1 as a combination of two data alarms. In S151 and S152, the combination is confirmed. If the combination is, for example, the first combination, the analysis control unit 50 outputs two data alarms, namely the first data alarm and the second data alarm, as outputs corresponding to the first combination in S153. The processing content at this time is the same as that of Implementation 1 Fig.11 The processing contents of S401 and S402 of the high-level data alarm processing are the same.

[0253] In addition, for example, in S154, the analysis control unit 50 determines whether the aforementioned reagent shortage alarm A2 is attached as the second data alarm of the second measurement result. In the case of an attachment (yes), enter S155, and in the case of no attachment (no), enter other steps (omitted). That is, in S151 and S154, the combination of the first data alarm being the sample shortage alarm A1 and the second data alarm being the reagent shortage alarm A2 is confirmed. If the analysis control unit 50, for example, regards this combination as the second combination, then in S155, the first data alarm and the second data alarm are output as outputs corresponding to the second combination.

[0254] As in the above processing flow example, in the automatic analyzer 1 of the second embodiment, for two types of data alarms, a combination that matches all possible combinations of data alarms is identified, and output is selected based on a predetermined criterion similarly to the first embodiment based on the identified combination.

[0255] As described above, according to the second embodiment, the same effects as those of the first embodiment can be obtained.

[0256] (Implementation 3)

[0257] use Fig.16 , Fig.17 , an automatic analyzer according to a third embodiment of the present invention is described. In the automatic analyzer 1 according to the third embodiment, through the judgment of the analysis control unit 50, not only data alarms corresponding to abnormalities during measurement are annotated in each measurement result of the two photometers, but also automatic re-test information about the automatic re-test function is prepared and attached. In particular, the analysis unit 52 notates data alarms corresponding to abnormalities in the measurement results of a certain photometer, and judges whether automatic re-testing and re-measurement conditions are required. Then, the analysis unit 52 associates the automatic re-testing information including information on whether automatic re-testing and re-measurement conditions are required with the information of the object test body 2 or the reaction container 25, the measurement results, and the data alarms, and attaches them, and stores them in the data storage unit 55 as analysis data.

[0258] The processing unit such as the simultaneous analysis determination unit 56 of the analysis control unit 50 refers to the analysis data including the measurement results, data alarms, and automatic re-examination information related to each of the two photometers stored in the above-mentioned data storage unit 55. And, the simultaneous analysis determination unit 56, etc. selects the output based on the combination of the data alarm and the automatic re-examination information in the two data based on the reference specified by the predetermined correspondence table. The selected output (i.e., the analysis result output information) includes the measurement results, data alarms, and automatic re-examination information in the same manner as in the first embodiment. As described above, in the automatic analysis device 1 of the third embodiment, the processing related to the automatic re-examination function is different from that in the first embodiment. As described above, in the third embodiment, the analysis unit 52 temporarily performs the judgment related to the automatic re-examination function on the measurement results of each photometer, and the automatic re-examination information is prepared and attached. In addition, the automatic re-examination information (the re-examination flag information described below) attached in the analysis unit 52 has a different meaning from the aforementioned automatic re-examination information. Thereafter, the analysis control unit 50 comprehensively reselects and determines the output including the automatic reinspection information based on the combination of the two measurement results including the automatic reinspection information and the data alarm.

[0259] [Automatic recheck information (recheck mark)]

[0260] In Embodiment 3, the analysis unit 52 creates and adds automatic re-inspection information (recorded as re-inspection flag information) in a predetermined format. For example, when the analysis unit 52 attaches a first data alarm corresponding to an abnormality during measurement to the first measurement result using the absorptometer 44, the analysis unit 52 determines whether automatic re-inspection is required, and the re-measurement conditions when necessary. The analysis unit 52 attaches the automatic re-inspection information (first re-inspection flag) corresponding to the judgment result to the first measurement result and the first data alarm. Similarly, when the analysis unit 52 attaches a second data alarm corresponding to an abnormality during measurement to the second measurement result using the scatterophotometer 45, the analysis unit 52 determines whether automatic re-inspection is required, and the re-measurement conditions when necessary. The analysis unit 52 attaches the automatic re-inspection information (second re-inspection flag) corresponding to the judgment result to the second measurement result and the second data alarm.

[0261] The recheck flag is a value indicating whether automatic recheck using the corresponding type of photometer is required (existence), remeasurement conditions, etc. The analysis unit 52 associates the data including the measurement result, data alarm, and recheck flag with the analysis request information of the reaction container 25 or the corresponding sample 2 in which the measurement value of the object is obtained, and stores them in the data storage unit 55.

[0262] In the third embodiment, the reinspection flag is classified into the following four types according to the type of the data alarm: The identifiers of the reinspection flag are F1 to F4.

[0263] (1) First recheck flag F1 = "no recheck flag": The first recheck flag F1 indicates that automatic recheck is not required (no). In addition, instead of adding the first recheck flag F1, the recheck flag itself may not be added.

[0264] (2) Second recheck flag F2 = "same condition recheck flag": The second recheck flag F2 indicates that automatic recheck is required (existed), and the conditions are set to be the same remeasurement conditions as those in the previous measurement (i.e., when an abnormality is detected, etc.).

[0265] (3) Third retest flag F3 = "retest flag with reduced volume": The third retest flag F3 indicates that automatic retest is necessary (present), and sets the condition to reduce the test volume compared to the condition at the time of the previous measurement.

[0266] (4) Fourth retest flag F4 = "incremental retest flag": The fourth retest flag F4 indicates that automatic retest is necessary (present), and sets the condition to increase the test volume compared to the condition at the time of the previous measurement.

[0267] As the processing flow in the third embodiment, for example, for the first embodiment described above Fig.10 The level determination process Fig.11 The high-level data alarm processing part is the same.

[0268] [Processing Flow]

[0269] Fig.16 , Fig.17 The flow of the medium-level data alarm processing performed by the analysis control unit 50 (particularly the simultaneous analysis determination unit 56 and the like) in the third embodiment is shown. Fig.16 Represents from step S701 to step S708. Fig.17 then Fig.16 , indicating from step S709 to step S720. This process is like Fig.10 The flow to step S304 is performed when the data alarms appended to the two measurement results include a medium-level data alarm. Fig.16 In the processing example, the output is selected based on the judgment of the above-mentioned re-inspection flag.

[0270] (S701) The analysis control unit 50 determines whether a "re-check flag for reduction" (third re-check flag F3) is added as a re-check flag to the first measurement result and the first data alarm of the absorptiometer 44. If added (Yes), the process proceeds to S702, and if not added (No), the process proceeds to S704.

[0271] (S702, S703) In S702, the analysis control unit 50 causes the output unit 71 to output the first measurement result and the first data alarm. And, in S703, the analysis control unit 50 stores the automatic re-test request information that determines that the automatic re-test is necessary and sets the condition of reducing the test volume relative to the previous condition in the data storage unit 55. The analysis control unit 50 controls the automatic re-test according to the automatic re-test request information and outputs the result. After S703, this process ends.

[0272] The above-mentioned "re-test mark with reduced amount" (third re-test mark F3) is added when the concentration of the target component substance of the test body 2 is too high. When the first measurement result using the absorptometer 44 suitable for measuring high-concentration components is judged to be too high (for example, exceeding the upper limit of the quantitative range), the reliability of the second measurement result using the scattering photometer 45 suitable for measuring low-concentration components is also low. Therefore, in this case, the party outputting the first measurement result automatically re-tests under the conditions of the reduced amount as described above. Thus, an attempt is made to make the measurement result during the re-test fall within the quantitative range of the absorptometer 44.

[0273] (S704) The analysis control unit 50 determines whether an "increment recheck flag" (fourth recheck flag F4) is added to the second measurement result and the second data alarm of the scatterphotometer 45. If added (Yes), the process proceeds to S705, and if not added (No), the process proceeds to S707.

[0274] (S705, S706) In S705, the analysis control unit 50 causes the output unit 71 to output the second measurement result and the second data alarm. And in S706, the analysis control unit 50 stores the automatic reinspection request information that sets the condition of increasing the detection volume relative to the previous condition in the data storage unit 55. The analysis control unit 50 controls the automatic reinspection according to the automatic reinspection request information. After S705, this process ends.

[0275] The above-mentioned "incremental re-test mark" (fourth re-test mark F4) is added when the concentration of the target component substance of the test body 2 is too low. When the second measurement result using the scattering photometer 45 suitable for the measurement of low-concentration components is determined to be too low in concentration (for example, below the lower limit of the quantitative range), the reliability of the first measurement result using the absorptometer 44 suitable for the measurement of high-concentration components is low. Therefore, in this case, the party that outputs the second measurement result automatically re-tests under the conditions of the above-mentioned increment. Thus, an attempt is made to make the measurement result during re-testing fall within the quantitative range of the scattering photometer 45 or the absorptometer 44.

[0276] (S707) The analysis control unit 50 determines whether a "no re-examination flag" (first re-examination flag F1) is added to the second measurement result and the second data alarm. Alternatively, this step S707 can also be set to confirm whether the re-examination flag itself is added. If it is added (yes), proceed to S708, and if it is not added (no), proceed to S709.

[0277] ( S708 ) The analysis control unit 50 causes the output unit 71 to output the second measurement result and the second data alarm without performing automatic re-examination. After S708 , this flow ends.

[0278] (S709) Fig.17 In the case of entering S709, as the re-inspection flag accompanying the second measurement result, it corresponds to the case of "re-inspection flag of reduced amount" (third re-inspection flag F3) or "re-inspection flag of same condition" (second re-inspection flag F2). In S709, the analysis control unit 50 determines whether the "re-inspection flag of reduced amount" (third re-inspection flag F3) is added to the second measurement result and the second data alarm. If it is added (yes), enter S710, if not added (no), enter S713.

[0279] ( S710 ) The analysis control unit 50 outputs the first measurement result of the absorptiometer 44 and the first data alarm via the output unit 71 .

[0280] (S711) Furthermore, the analysis control unit 50 determines whether a same condition re-examination flag (second re-examination flag F2) is added to the first measurement result. If added (Yes), the process proceeds to S716, and if not added (No), the process proceeds to S712.

[0281] (S716) The analysis control unit 50 stores the automatic reinspection request information for setting the conditions to be the same as those in the previous measurement in the data storage unit 55. The analysis control unit 50 controls the automatic reinspection according to the automatic reinspection request information. After S716, this flow ends.

[0282] (S712) In addition, when entering S712, the analysis control unit 50 further determines whether an incremental re-check flag (fourth re-check flag F4) is added to the first measurement result. If it is added (yes), it proceeds to S706. If it is not added (no), it does not perform automatic re-check and ends this process.

[0283] (S713) The analysis control unit 50 determines whether the same condition re-examination flag (second re-examination flag F2) is added to the first measurement result. If it is added (Yes), the process proceeds to S714, and if it is not added (No), the process proceeds to S718.

[0284] (S714) The analysis control unit 50 performs a priority output determination according to the "priority output setting". If it is "absorption priority output" (A), the process proceeds to S715, and if it is "scattering priority output" (B), the process proceeds to S717.

[0285] ( S715 ) The analysis control unit 50 causes the output unit 71 to output the first measurement result using the absorptiometer 44 and the corresponding first data alarm according to the “absorption priority output”.

[0286] ( S717 ) The analysis control unit causes the output unit 71 to output the second measurement result using the scatter photometer 45 and the corresponding second data alarm according to the “scattering priority output”.

[0287] ( S716 ) After S715 or S717 , in S716 , the analysis control unit 50 stores the automatic retest request information in the data storage unit 55 , which sets the conditions to be the same as those in the previous measurement.

[0288] ( S718 ) The analysis control unit 50 causes the output unit 71 to output the first measurement result using the absorptiophotometer 44 and the first data alarm.

[0289] (S719) Furthermore, the analysis control unit 50 determines whether an incremental recheck flag (fourth recheck flag F4) is added to the first measurement result. If added (Yes), the process proceeds to S720. If not added (No), the process ends without performing automatic recheck.

[0290] (S720) The analysis control unit 50 stores the automatic retest request information, which sets the condition for increasing the sample volume compared with the previous condition, in the data storage unit 55. After S720, this flow ends.

[0291] As shown in the above processing example, in the third embodiment, based on the combination of the measurement result, data alarm, and re-test flag of each photometer, the output (measurement result, data alarm, and automatic re-test information) is comprehensively selected. Thus, even if there is an abnormality in both sides of the two measurements, the automatic re-test can be properly controlled and the re-measurement can be performed quickly. Therefore, while being able to obtain more accurate results, it is also possible to prevent the user's result report from being delayed.

[0292] In addition, as the above-mentioned automatic retest conditions, i.e., re-measurement conditions, when determining the conditions for reducing the detection volume or increasing the detection volume, for example, the following method can be used. As this method, a predetermined value of a predetermined amount or ratio is used, and the value of the previous condition is reflected by adding or multiplying the predetermined value of the predetermined amount or ratio, thereby determining the detection volume of the re-measurement condition. Alternatively, as another method, a plurality of candidate detection volume conditions can be defined and set in advance, and the detection volume of the re-measurement condition can be determined by selecting and switching from these conditions.

[0293] As mentioned above, although this invention was specifically described based on embodiment, this invention is not limited to the said embodiment, Various changes are possible within the range which does not deviate from the summary.

[0294] Explanation of symbols

[0295] 1 ... automatic analyzer, 2 ... sample, 3 ... reaction solution, 4 ... reagent, 25 ... reaction container, 44 ... absorption photometer, 45 ... scatter photometer, 50 ... analysis control unit.

Claims

1. An automatic analysis device, Features: have: a control unit for controlling analysis using a plurality of photometers having different quantitative ranges for a target sample, and an analysis unit that performs analysis processing corresponding to automatic analysis, The control unit performs: acquiring a plurality of measurement results including a plurality of measurement values ​​using the plurality of photometers, When an abnormality is detected during measurement using the plurality of photometers, a data alarm corresponding to the type of the abnormality is added to a measurement result using a corresponding photometer among the plurality of measurement results; When a plurality of data alarms are appended to the plurality of measurement results, the measurement results and data alarms to be output are determined according to a correspondence table defining associations between the plurality of data alarm combinations and outputs.

2. The automatic analysis device according to claim 1, in, The control unit selects automatic re-inspection information corresponding to the combination of the multiple data alarms, and controls the automatic re-inspection based on the automatic re-inspection information. The automatic re-inspection information includes whether automatic re-inspection of the object detection body is required, the type of photometer used in the automatic re-inspection, and the re-measurement conditions in the automatic re-inspection.

3. The automatic analysis device according to claim 2, in, The data alarm is classified into multiple levels: high level, medium level, and low level. The high level is a level that requires the automatic re-inspection and requires the user to perform a state improvement operation for the automatic re-inspection. The middle level is a level that requires the automatic recheck and does not require the user to perform a state improvement operation for the automatic recheck. The low level is a level that does not require the automatic re-inspection. The control unit determines the level with respect to the combination of the data alarms, and selects the automatic reinspection information to be output according to the level.

4. The automatic analysis device according to claim 3, in, The high-level data alarm includes at least one of a sample shortage alarm, a reagent shortage alarm, a clogging detection alarm, a detergent shortage alarm, and a photometer abnormality alarm.

5. The automatic analysis device according to claim 3, in, The intermediate-level data alarms include data alarms due to abnormal reaction process and data alarms due to abnormal sample concentration. As the data alarm generated due to the abnormal reaction process, there is at least one of a cell blank abnormal alarm, an absorbance difference normal alarm, and a scattered light intensity difference normal alarm. The data alarm generated due to abnormal sample concentration includes at least one of a prozone alarm, an alarm exceeding an upper limit of a quantitative range, and an alarm exceeding a lower limit of a quantitative range.

6. The automatic analysis device according to claim 3, in, As the low-level data alarm, there is at least one of a serum information alarm and a reagent validity period expiration alarm.

7. The automatic analysis device according to claim 1, in, The parsing unit performs: adding recheck flag information to each measurement result of the photometer, the recheck flag information being used to control the automatic recheck based on the result of the judgment of attaching the data alarm and the judgment on the automatic recheck, An analysis result including the measurement result to be output, the data alarm, and the automatic re-examination information is selected in accordance with a combination of a plurality of reinspection flag information added to the plurality of measurement results.

8. The automatic analysis device according to claim 1, in, As the priority output setting, it is preset which photometer among the plurality of photometers is to be used as the priority output. When the combination serving as the data alarm is a specific combination, the control unit selects the measurement result and the data alarm to be output based on the priority output setting.

9. The automatic analysis device according to claim 1, in, As the data alarm, a plurality of data alarms that may be generated are set with a ranking corresponding to the importance. When the control unit adds the data alarm to each of the measurement results of the photometer, the control unit adds one data alarm selected according to the importance.

10. The automatic analysis device according to claim 2, in, The re-measurement conditions include: the same conditions as those in the previous measurement, the conditions under which the amount of the sample volume is reduced, and the conditions under which the amount of the sample volume is increased.

11. An automatic analysis method in an automatic analysis device, It is characterized in that The automatic analysis device comprises: a control unit for controlling analysis using a plurality of photometers having different quantitative ranges for a target sample, and an analysis unit that performs analysis processing corresponding to automatic analysis, The steps performed in the control unit include: a step of acquiring a plurality of measurement results including a plurality of measurement values ​​using the plurality of photometers; When an abnormality is detected during measurement using the plurality of photometers, a data alarm corresponding to the type of the abnormality is added to a measurement result using a corresponding photometer among the plurality of measurement results; as well as A step of determining the measurement results and the data alarms to be output according to a correspondence table defining associations between the plurality of data alarm combinations and outputs when the plurality of measurement results are annotated with the plurality of data alarms.

12. The automatic analysis method according to claim 11, in, The analyzing unit has: corresponding to the combination of the multiple data alarms, selecting automatic re-inspection information, and controlling the automatic re-inspection steps according to the automatic re-inspection information, wherein the automatic re-inspection information includes whether the automatic re-inspection of the object detection body is required, the type of photometer used in the automatic re-inspection, and the re-measurement conditions in the automatic re-inspection.

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