阅读说明：本技术 自动分析装置以及自动分析方法 (Automatic analysis device and automatic analysis method ) 是由 风间佑斗 饭岛昌彦 薮谷千枝 小暮研二 于 2018-09-06 设计创作，主要内容包括：本发明提供自动分析装置,具备控制分析的控制部,所述分析对于对象检测体使用定量范围不同的多个校准线,所述控制部进行：取得包含使用了所述多个校准线的多个测定值在内的多个测定结果,在使用了所述多个校准线的测定时,在检测到异常的情况下,对所述多个测定结果中的使用了对应的校准线的测定结果,附记与所述异常的类别对应的数据警报,在所述多个测定结果中附记有多个数据警报的情况下,基于所述多个测定结果以及所述多个数据警报,决定要输出的测定结果以及数据警报。(The present invention provides an automatic analyzer including a control unit for controlling an analysis using a plurality of calibration lines having different quantitative ranges for a target specimen, the control unit performing: when an abnormality is detected in measurement using the plurality of calibration lines, a data alarm corresponding to the type of the abnormality is attached to a measurement result using a corresponding calibration line among the plurality of measurement results, and when a plurality of data alarms are attached to the plurality of measurement results, the measurement result and the data alarm to be output are determined based on the plurality of measurement results and the plurality of data alarms.)

1. An automatic analyzer, characterized in that:

comprises a control unit for controlling analysis using a plurality of calibration lines having different quantitative ranges for a target specimen,

the control unit performs:

obtaining a plurality of measurement results including a plurality of measurement values using the plurality of calibration lines,

when an abnormality is detected in the measurement using the plurality of calibration lines, a data alarm corresponding to the type of the abnormality is added to the measurement result using the corresponding calibration line among the plurality of measurement results,

when a plurality of data alarms are added to the plurality of measurement results, the measurement results and the data alarms to be output are determined based on the plurality of measurement results and the plurality of data alarms.

2. The automatic analysis device according to claim 1,

the control unit selects automatic reinspection information including whether or not automatic reinspection of the target specimen is required, a type of a calibration line used for the automatic reinspection, and a retesting condition in the automatic reinspection, in accordance with a combination of the plurality of data alarms, and controls the automatic reinspection based on the automatic reinspection information.

3. The automatic analysis device according to claim 2,

the data alert is classified as a plurality of levels into a high level, a medium level, a low level,

the high level is a level that requires the automatic review and a user to perform a status improvement job for the automatic review,

the intermediate level is a level at which the automatic review is required and the user is not required to perform a status improvement job for the automatic review,

the low level is a level at which the automatic review is not required,

the control unit determines the level of the combination of the data alarms, and selects the automatic review information to be output in accordance with the level.

4. The automatic analysis device according to claim 3,

the high-level data alarm includes at least one of a detection shortage alarm, a reagent shortage alarm, a blockage detection alarm, a detergent shortage alarm, and a photometer abnormality alarm.

5. The automatic analysis device according to claim 3,

the medium-level data alarms include data alarms caused by abnormal reaction processes and data alarms caused by abnormal concentrations of the samples,

the data alarm generated by the abnormal reaction process is at least one of a unit blank abnormal alarm, an absorbance difference constant alarm and a scattered light intensity difference constant alarm,

the data alarm generated due to the abnormality of the concentration of the detection object includes at least one of a prozone alarm, an alarm exceeding the upper limit of the quantitative range, and an alarm exceeding the lower limit of the quantitative range.

6. The automatic analysis device according to claim 3,

as the low-ranked data alert, there is at least one of a serum information alert and an agent expiration alert.

7. The automatic analysis device according to claim 2,

the control unit performs:

adding review flag information for controlling the automatic review based on a result of the determination that the data alarm is added and the determination regarding the automatic review to each measurement result of the calibration line,

selecting an analysis result including the measurement result to be output, the data alarm, and the automatic review information in correspondence with a combination of a plurality of review flag information added to the plurality of measurement results.

8. The automatic analysis device according to claim 1,

as the priority output setting, which of the plurality of calibration lines is used as the priority output is set in advance,

when the combination of the data alarms is a specific combination, the control unit selects the measurement result and the data alarms to be output, based on the priority output setting.

9. The automatic analysis device according to claim 1,

as the data alarm, a bit number corresponding to the importance degree is set for a plurality of data alarms that may be generated,

the control unit adds one data alarm selected according to the importance when adding the data alarm to each measurement result of the calibration curve.

10. The automatic analysis device according to claim 2,

the re-measurement conditions include: the same conditions as those in the previous measurement, the condition for decreasing the amount of the analyte, and the condition for increasing the amount of the analyte.

11. An automatic analysis method in an automatic analysis apparatus,

the automatic analyzer includes a control unit for controlling an analysis using a plurality of calibration lines having different quantitative ranges for a target specimen,

the steps executed in the control unit include:

obtaining a plurality of measurement results including a plurality of measurement values using the plurality of calibration lines;

a step of, when an abnormality is detected in the measurement using the plurality of calibration lines, adding a data alarm corresponding to the type of the abnormality to a measurement result using a corresponding calibration line among the plurality of measurement results; and

and determining a measurement result and a data alarm to be output based on the plurality of measurement results and the plurality of data alarms when the plurality of measurement results are associated with the plurality of data alarms.

12. The automated analysis method of claim 11, wherein,

the control unit includes: and a step of selecting automatic reinspection information including whether or not the automatic reinspection on the target specimen is required, a type of a calibration line used in the automatic reinspection, and a retesting condition in the automatic reinspection, in accordance with a combination of the plurality of data alarms, and controlling the automatic reinspection on the basis of the automatic reinspection information.

Technical Field

The present invention relates to a technique of an automatic analyzer for clinical examination. The present invention also relates to a technique for outputting an alarm corresponding to an abnormality, an error, or the like in an automatic analyzer.

Background

An automatic analyzer for clinical examination detects the concentration and amount of a target component substance contained in a specimen (also referred to as a sample) such as blood or urine based on optical measurement. As a method for detecting a target component substance, an absorptiometry method for measuring the amount of transmitted light of a specimen is frequently used. In the absorptiometry, a specimen or a reaction solution (a mixture of the specimen and a reagent) is irradiated with light from a light source, and the amount of transmitted light or the like of one or more wavelengths obtained from the result is measured to calculate absorbance. In addition, in the absorptiometry, the amount of a component of a target component substance is determined from the relationship between absorbance and concentration according to the Lambert-Beer law.

As an automatic analyzer for clinical examination, for example, a highly sensitive device for immunoassay is known which uses a light scattering detection method which utilizes a 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 aggregate produced by an antigen-antibody reaction, and at least one of the light intensity and the light intensity of scattered light scattered by the aggregate is measured. In the light scattering detection method, the amount of the target component substance is determined from the relationship between the amount of light or intensity of light and concentration.

An absorptiometer, which is a photometer using absorptiometry, and a scatterometer, which is a photometer using a light scattering detection method, have differences in characteristics including a measurable and quantifiable range (sometimes referred to as a "quantitative range" or the like). Therefore, in recent years, an automatic analyzer has been developed which uses the difference in the characteristics of both the two types of photometers to mount the two types of photometers on 1 stage and expand the dynamic range of measurement.

An example of a conventional technique relating to the automatic analyzer is japanese patent application laid-open No. 2014-6160 (patent document 1). Patent document 1 describes an automatic analyzer that can determine an optimum photometer from a concentration range among a scattering photometer and an absorption photometer.

Documents of the prior art

Patent document

Patent document 1: japanese patent laid-open No. 2014-6160

Disclosure of Invention

Problems to be solved by the invention

However, in order to improve the reliability of the measurement result, the automatic analyzer for clinical examination often has a function of outputting an alarm (which may be referred to as a data alarm function) as described below. In this function, when an abnormality, an error, or the like in measurement is monitored and detected, predetermined data indicating the type of the abnormality or the like is added as a data alarm to the measurement result information and is output.

When the abnormality or the like at the time of measurement is slight, there is a high possibility that an appropriate measurement result can be obtained by performing re-measurement or the like after the handling such as dilution of the specimen. Therefore, an automatic analyzer having a function of automatically performing a reinspection including a remeasurement based on the abnormality or the like (sometimes referred to as an automatic reinspection function) has been developed.

For example, patent document 1 discloses a method of selecting and outputting measurement results of two photometers in a case of normal measurement, in other words, in a case where no abnormality or the like is detected in an automatic analyzer. However, in an automatic analyzer having two or more types of photometers and having a data alarm function, a function of selecting a measurement result, and the like, it has not been studied how to select an output from the two or more types of measurement results and the data alarm when there is an abnormality or the like at the time of measurement. For example, in the case of analysis using two types of photometers in this apparatus, there is a possibility that an abnormality is detected by measurement in each photometer, and a data alarm is given to both measurement results. That is, there are cases where two or more kinds of multiple data alarms are generated simultaneously. In this case, it is not clear how to select an output to the user as appropriate.

In the above automatic analyzer, when all of the plurality of types of measurement results and data alarms are output or when one of the plurality of types of measurement results and data alarms is selected and output, in either case, it may be difficult for the user to determine the result. It is difficult for the user to understand what state or meaning the output indicates, and it is necessary to determine whether or not the measurement is correct, the suitability, whether or not re-inspection or handling work is necessary, and the like, and it is necessary to perform work and operation corresponding to the determination. That is, in the automatic analyzer, the burden on the user is large for the output, and there is a possibility that a determination error, a result report delay, or the like occurs.

In addition, in the above automatic analyzer, it has not been studied how to appropriately control re-measurement in consideration of further combination with the automatic re-inspection function, or in the case where two or more kinds of plural data alarms are generated, and the automatic re-inspection function cannot be effectively utilized.

An object of the present invention is to provide a technique relating to an automatic analyzer including two or more types of photometers, which can realize appropriate outputs from measurement results of the photometers and data alarms even when there is an abnormality or the like at the time of measurement. That is, a technique is provided which can reduce the burden on the user for output and can prevent a determination error, a delay in result report, and the like. Another object of the present invention is to provide a technique for realizing more accurate measurement at high speed by appropriate control of re-measurement even in the case of an automatic analyzer having an automatic re-inspection function.

Means for solving the problems

A typical embodiment of the present invention is an automatic analyzer, and is characterized by having the following configuration. An automatic analyzer according to an embodiment includes: a plurality of photometers having different quantitative ranges, and an analysis controller for controlling analysis including measurement performed using the photometers with respect to a target specimen, the analysis controller performing: obtaining a plurality of measurement results including a plurality of measurement values using the plurality of photometers; when an abnormality is detected in a measurement using the 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 added to the plurality of measurement results, a measurement result and a data alarm to be output are selected from the plurality of measurement results and the plurality of data alarms in accordance with a combination of the plurality of data alarms, and the selected measurement result and the selected data alarm are output to a user as an analysis result.

Effects of the invention

According to a representative embodiment of the present invention, the present invention relates to a technique of an automatic analyzer including two or more types of photometers, which can realize appropriate outputs from measurement results of the photometers and data alarms even when there is an abnormality or the like at the time of measurement. That is, the burden on the user for output can be reduced, and determination errors, delay in result reporting, and the like can be prevented. In addition, according to the exemplary embodiment, even in the case of an automatic analyzer further having an automatic review function, more accurate measurement can be realized at high speed by appropriate control of the re-measurement.

Drawings

Fig. 1 is a diagram showing an overall schematic configuration of an automatic analyzer according to embodiment 1 of the present invention.

Fig. 2 is a diagram mainly showing a functional block configuration of an analysis control unit in the automatic analyzer according to embodiment 1.

Fig. 3 is a diagram showing characteristics of two photometers in the automatic analyzer according to embodiment 1.

Fig. 4 is a table showing classification definitions of data alarms in the automatic analyzer according to embodiment 1.

Fig. 5 is a diagram showing a first part of a correspondence table between data alarms and outputs in the automatic analyzer according to embodiment 1.

Fig. 6 is a diagram showing a second part as a correspondence table in the automatic analyzer according to embodiment 1.

Fig. 7 is a diagram showing a third part as a correspondence table in the automatic analyzer according to embodiment 1.

Fig. 8 is a diagram showing a fourth part of the correspondence table in the automatic analyzer according to embodiment 1.

Fig. 9 is a diagram showing a flow of output control processing in the automatic analyzer according to embodiment 1.

Fig. 10 is a diagram showing a flow of a priority output alarm determination process in embodiment 1.

Fig. 11 is a diagram showing a flow of high-level data alarm processing in embodiment 1.

Fig. 12 is a diagram showing a flow of a first part of the middle-level data alarm processing in embodiment 1.

Fig. 13 is a diagram showing a flow of the second part of the middle-level data alarm processing in embodiment 1.

Fig. 14 is a diagram showing a flow of low-level data alarm processing in embodiment 1.

Fig. 15 is a diagram showing an example of a process flow in the automatic analyzer according to embodiment 2 of the present invention.

Fig. 16 is a diagram showing a flow of a first part of the middle-level data alarm processing in the automatic analyzer according to embodiment 3 of the present invention.

Fig. 17 is a diagram showing a flow of the second part of the middle-level data alarm processing in embodiment 3.

Detailed Description

Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. In all the drawings for explaining the embodiments, the same parts are denoted by the same reference numerals in principle, and redundant explanations thereof are omitted.

[ problems ] to solve

The premise, the problem, and the like will be described supplementarily. For the reaction between the specimen and the reagent, two types of reactions, i.e., a color reaction and an agglutination reaction, are roughly used. The color reaction is a reaction between a substrate and an enzyme, and is used for biochemical analysis. In biochemical analysis, the amount of light absorbed (expressed as absorbance) from the developed reaction solution is measured to determine the amount of components. Agglutination is a reaction between an antigen and an antibody, and is used in an immunoassay. In the immunoassay, turbidity (expressed as turbidity) of a reaction solution that changes due to agglutination of an antigen and an antibody is measured from a change in the amount of transmitted light, and the amount of components is determined. Target component substances measured by immunoassay are generally low in blood concentration, and a highly sensitive detection system is desired. Therefore, in the immunoassay, a latex immunoturbidimetry method or the like has been developed. In the latex immunoturbidimetry, a reagent for sensitizing and binding an antibody or an antigen to the surface of latex particles is used, and the size of an aggregate generated by an antigen-antibody reaction is increased to increase the turbidity change, thereby realizing highly sensitive measurement.

In general, the light scattering detection method has high detection sensitivity and good quantification performance for low-concentration samples, but has poor quantification performance due to the influence of multiple scattering because of many aggregates in high-concentration samples. On the other hand, in general, the absorptiometry is not high in detection sensitivity for a low-concentration specimen, but is excellent in quantitativity for a high-concentration specimen and also has a wide range of concentration that can be quantitated, as compared with the light scattering detection method. As described above, there is a difference in characteristics between a photometer using absorptiometry, that is, an absorptiometer, and a photometer using a light scattering detection method, that is, a scattering photometer, including a range capable of measurement and quantification. Therefore, in recent years, an automatic analyzer has been developed which uses the difference in the characteristics of both the two types of photometers to mount the two types of photometers on 1 stage and expand the dynamic range of measurement. In this automatic analyzer, for example, measurement results of a scattering photometer are used in a low concentration region, and measurement results of an absorption photometer are used in a high concentration region.

Patent document 1 discloses a method of selecting a photometer with high sensitivity based on a variation in measurement values of a standard solution used for preparing a calibration curve of each photometer, as a selection criterion of the photometer. Further, a method is disclosed in which a plurality of concentration ranges are set in advance, and two types of photometers are switched in accordance with a concentration range suitable for the measurement value of the photometer.

As an automatic analyzer of a comparative example against the embodiment of the present invention, an automatic analyzer including an absorption photometer using an absorption photometer and a scattering photometer using a light scattering detection method, which are two photometers in the related art, is considered. The automatic analyzer has a function of simultaneously performing measurement and analysis, that is, a simultaneous analysis function, using two types of photometers. The automatic analyzer has a function of adding a data alarm, that is, a data alarm function, to a measurement result based on detection of an abnormality or the like at the time of measurement. The automatic analyzer has a function of selecting and outputting an appropriate measurement result from the measurement results of the two photometers based on a predetermined judgment when performing simultaneous analysis. As a criterion and a method for selecting the output, for example, a method of selecting a measurement result of a photometer having an appropriate quantitative range for the concentration of the target specimen may be mentioned.

However, in the automatic analyzer according to this comparative example, when an abnormality or the like occurs during measurement in the case of performing simultaneous analysis, two types of data alarms may be generated based on two types of measurement results. The measurement result and the data alarm are obtained independently from each other by an absorption photometer and a scattering photometer. In this case, it has not been examined how to select a measurement result and a data alarm to be output from among two kinds of measurement results and data alarms. In the apparatus of the comparative example, when the two types of measurement results and data alarms are generated, it is not preferable to select the measurement result and data alarm having the lower reliability, because the selection may cause a judgment error by the user, a delay in reporting the result, and the like.

(embodiment mode 1)

An automatic analysis device and an automatic analysis method according to embodiment 1 of the present invention will be described with reference to fig. 1 to 14. The automatic analysis method according to embodiment 1 is a method having steps executed by the automatic analysis device according to embodiment 1.

The automatic analyzer according to embodiment 1 includes an absorption photometer and a scattering photometer as two photometers, and has a data alarm function, a simultaneous analysis function, and the like. The data alarm function is a function of, when an abnormality or the like at the time of measurement is detected, adding a data alarm corresponding to the abnormality or the like to the measurement result. The simultaneous analysis function is a function of simultaneously performing measurement and analysis ("simultaneous absorption and scattering analysis") using two photometers. The automatic analyzer according to embodiment 1 has a function of selecting an appropriate measurement result from a plurality of measurement results based on a target component substance of an examination item and an appropriate quantitative range of each photometer when performing simultaneous analysis, and can perform measurement in a wide dynamic range.

The automatic analyzer according to embodiment 1 has a function (sometimes referred to as an output control function) of appropriately selecting and outputting a measurement result and a data alarm even when two types of measurement results and data alarms are obtained due to an abnormality or the like at the time of measurement when simultaneous analysis is performed. In this function, the measurement result, the data alarm, and the like to be output are appropriately selected according to the combination of the data alarms. The measurement result includes quantitative values such as a measurement value and a calculation value, a signal value, analysis result information, and the like.

The automatic analyzer according to embodiment 1 further includes an automatic review function, and even when two kinds of measurement results and data alarms are obtained as described above, the automatic review is appropriately controlled by the output control function. That is, the automatic analyzer according to embodiment 1 appropriately selects the measurement result, the data alarm, and the automatic re-inspection information to be output, and controls automatic re-inspection and the like, based on the combination of the data alarms. The automatic retest information includes whether or not automatic retest is necessary, identification information of the photometer used, retest conditions (for example, conditions for diluting the specimen), and the like.

[ automatic analysis device ]

Fig. 1 is a schematic diagram showing the overall configuration of an automatic analyzer 1 according to embodiment 1. The automatic analyzer 1 includes: a test body 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, and the like. The detection body disk 10 is provided with a drive unit 12. The reaction disk 20 is provided with a drive unit 22. The reagent disk 30 is provided with a drive unit 32. In addition, two types of photometers, an absorption photometer 44 and a scattering photometer 45, are provided on the reaction disk 20. The reaction disk 20 is provided with a thermostatic bath 28. The reaction disk 20 is provided with a stirring section 43, a washing section 46, and the like.

The computer 100 includes: an analysis control unit 50, a storage unit 70, an output unit 71, an input unit 72, and the like. The analysis control unit 50 is connected to each driving unit and each mechanism via an interface circuit 101 including a signal line and the like. The computer 100 is constituted by, for example, a PC, but is not limited thereto, and may be constituted by a circuit board such as an LSI board, or a combination thereof. The storage unit 70 is constituted by a storage device such as a ROM, a RAM, or a nonvolatile storage device.

A plurality of sample cups 15 are provided and held in the sample tray 10. The sample cup 15 is a sample container for accommodating the sample 2. The sample cups 15 are held in the tray main body 11 of the sample tray 10 so as to be spaced apart from each other in the circumferential direction and arranged side by side.

The drive unit 12 of the detection target disk 10 drives and controls the detection target disk 10 under the control of the analysis control unit 50 (the control unit 53 in fig. 2). At this time, the drive unit 12 rotates the disk main body 11, thereby moving the plurality of sample cups 15 in the circumferential direction. The sample tray 10 arranges one sample cup 15 of a plurality of sample cups 15 provided in the tray main body 11 at a predetermined position in the circumferential direction by drive control of the drive unit 12. The predetermined position is, for example, a sample suction position of the sample dispensing mechanism 41.

In the configuration example of fig. 1, the plurality of detection cups 15 are arranged in a row on the disk main body 11 along the circumferential direction in the detection body disk 10. However, the present invention is not limited to this, and the sample cups 15 may be arranged in a plurality of rows in a concentric circle shape of the disk main body 11. In the configuration example of fig. 1, the disk-shaped detection body disk 15 is provided, but the present invention is not limited thereto, and a rack type may be used. A rack type specimen rack in which a plurality of specimen containers are arranged and held one-dimensionally or two-dimensionally is used.

The reagent disk 30 is disposed beside the reaction disk 20. A plurality of reagent bottles 35 are set and held in the tray main body 31 of the reagent tray 30. The reagent bottle 35 is a reagent container that contains the reagent 4. The reagent bottles 35 are separated from each other in the circumferential direction of the tray main body 31 and are held in parallel. The reagent bottle 35 contains a reagent 4 of a type corresponding to a target component substance of an examination item in the automatic analyzer 1. The reagent bottles 35 are respectively accommodated for each kind of reagent 4.

The drive unit 32 of the reagent disk 30 rotates the disk main body 31 and moves the plurality of reagent bottles 35 in the circumferential direction under the control of the analysis control unit 50. The reagent disk 30 arranges one reagent bottle 35 to be used among the plurality of reagent bottles 35 provided in the disk main body 31 at a predetermined position of the reagent disk 30 by the drive control of the drive unit 32. The predetermined position is, for example, a reagent suction position of the reagent dispensing mechanism 42.

The reagent disk 30 is provided with a reagent refrigerator 38 provided with a cooling mechanism. Even if the disk main body 31 rotates, the plurality of reagent bottles 35 arranged in the disk main body 31 are cooled while being constantly kept in the cooling environment of the reagent cooling warehouse 38. This prevents deterioration of the reagent 4. As the cooling mechanism of the reagent refrigerator 38, for example, a system of circulating low-temperature water, a system of cooling in a gas phase by a Peltier (Peltier) element, or the like can be used.

The reaction disk 20 is disposed between the detector disk 10 and the reagent disk 30. A plurality of reaction containers 25 are provided and held in the tray main body 21 of the reaction tray 20. The reaction vessel 25 is a vessel for preparing the reaction solution 3. The reaction solution 3 is a mixture of the specimen 2 and the reagent 4. The sample 2 is dispensed into the reaction container 25 by the sample dispensing mechanism 41, the reagent 4 is dispensed by the reagent dispensing mechanism 42, and the reaction solution 3 is prepared from a mixture of the sample 2 and the reagent 4. The reaction vessels 25 are spaced apart from each other in the circumferential direction of the disk main body 21 and are held in parallel. The reaction vessel 25 is made of a light-transmitting material for measurement by the absorption photometer 44 and the scattering photometer 45. The drive unit 22 of the reaction disk 20 rotates the disk main body 21 under the control of the analysis control unit 50, and moves the plurality of reaction containers 25 in the circumferential direction. The reaction disk 20 arranges one reaction vessel 25 among the plurality of reaction vessels 25 at a predetermined position provided in the circumferential direction by the rotation of the disk main body 21. The predetermined position is, for example, a sample discharge position of the sample dispensing mechanism 41, a reagent discharge position of the reagent dispensing mechanism 42, or the like.

The plurality of reaction containers 25 provided on the disk main body 21 of the reaction disk 20 are often immersed in the thermostatic bath water (also referred to as a thermostatic fluid) in the thermostatic bath 28. Thereby, the reaction solution 3 in the reaction vessel 25 is maintained at a constant reaction temperature (for example, about 37 ℃). The thermostatic bath water in the thermostatic bath 28 is controlled in temperature and flow rate by the analysis control unit 50 (the thermostatic fluid control unit 54 in fig. 2), and controls the amount of heat supplied to the reaction vessel 25.

On and near the circumference of the reaction disk 20, a stirring unit 43, an absorption photometer 44, a scattering photometer 45, a cleaning unit 46, and the like are disposed at mutually different positions in addition to the sample dispensing mechanism 41 and the reagent dispensing mechanism 42.

The sample dispensing mechanism 41 is provided between the test element disk 10 and the reaction disk 20. The sample dispensing mechanism 41 performs a sample dispensing operation of sucking the sample 2 from the sample cup 15 at the sample suction position of the sample disk 10 and discharging the sample to the reaction vessel 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 constituted by a pipette nozzle attached to a movable arm. The sample dispensing mechanism 41 moves the dispensing nozzle to the sample suction position on the sample disk 10 during the sample dispensing operation, and sucks a predetermined amount of the sample 2 from the sample cup 15 disposed at the sample suction position and stores the sucked sample into 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 disposed at the sample discharge position.

The reagent dispensing mechanism 42 is disposed between the reagent disk 30 and the reaction disk 20. The reagent dispensing mechanism 42 performs a reagent dispensing operation of sucking the reagent 4 from the reagent bottle 35 at the reagent suction position of the reagent disk 30 and discharging the reagent to the reaction vessel 25 at the reagent discharge position of the reaction disk 20. The dispensed reagent 4 is a reagent used for quantifying a target component substance, which is an analysis item (also referred to as an examination item) set in association with the target specimen 2. The reagent dispensing mechanism 42 similarly includes a movable arm and a dispensing nozzle. The reagent dispensing mechanism 42 moves the dispensing nozzle to a reagent suction position on the reagent disk 30 during a reagent dispensing operation, sucks a predetermined amount of the reagent 4 from the reagent bottle 35 disposed at the reagent suction position, and stores the reagent in the dispensing nozzle. Thereafter, the reagent dispensing mechanism 42 moves the dispensing nozzle to a reagent discharge position on the reaction disk 20, and discharges the reagent 4 in the dispensing nozzle into the reaction container 25 disposed at the reagent discharge position.

The sample dispensing mechanism 41 and the reagent dispensing mechanism 42 are provided with a cleaning unit 46, respectively, to prepare for dispensing different types of samples 2 and reagents 4. The cleaning unit 46 is a mechanism for cleaning the dispensing nozzle. Each dispensing mechanism cleans each dispensing nozzle by the cleaning unit 46 before and after the dispensing operation. This prevents the specimens 2 and the reagents 4 from being contaminated with each other. The dispensing nozzle of each dispensing mechanism is provided with a sensor for detecting the liquid level of the sample 2 or the liquid level of the reagent 4. This makes it possible to monitor and detect a measurement abnormality caused by a shortage of the sample 2 or the reagent 4. The sample dispensing mechanism 41 is provided with a pressure sensor for detecting clogging of the dispensing nozzle. This makes it possible to monitor and detect a dispensing abnormality caused by clogging of the dispensing nozzle with an insoluble substance such as fibrin contained in the specimen 2. The analysis control unit 50 can monitor and detect various abnormalities and the like during measurement by a mechanism including these sensors.

The stirring unit 43 stirs the mixed solution of the sample 2 and the reagent 4 in the reaction container 25 disposed at a predetermined position, i.e., a stirring position, on the reaction disk 20. Thereby, the liquid mixture in the reaction vessel 25 is uniformly stirred to promote the reaction, thereby producing the reaction solution 3. The stirring section 43 includes: for example, an agitation blade or an agitation mechanism using ultrasonic waves.

Of the two photometers, an absorption photometer 44 is provided as a first photometer, and a scattering photometer 45 is provided as a second photometer. Each of the absorption photometer 44 and the scattering photometer 45 has a light source and a light receiving unit as basic configurations. The light source of each photometer is disposed on the inner peripheral side of the reaction disk 20, for example, and the light receiving part of each photometer is disposed on the outer peripheral side of the reaction disk 20. Each photometer is connected to an analysis control unit 50 (measurement unit 51 in fig. 2).

The absorption spectrophotometer 44 measures the reaction solution 3 in the reaction well 25 disposed at a measurement position (particularly, a first measurement position) which is a predetermined position on the reaction disk 20. The scattering photometer 45 measures the reaction solution 3 in the reaction container 25 disposed at a measurement position (particularly, a second measurement position) which is a predetermined position on the reaction disk 20. In the configuration example of fig. 1, two photometers, an absorption photometer 44 and a scattering photometer 45, are provided at opposite predetermined positions on a diagonal line passing through the rotation center of the reaction disk 20 on the circumference of the reaction disk 20. An absorption photometer 44 is disposed at the first measurement position, and a scattering photometer 45 is disposed at the second measurement position. Further, the stirring section 43 and the cleaning section 46 are disposed at predetermined positions between the first measurement position and the second measurement position on the circumference.

The absorption photometer 44 irradiates the reaction solution 3 in the reaction well 25 at the first measurement position with light from the light source. At this time, the absorption photometer 44 detects the transmitted light obtained from the reaction solution 3 by the light receiving part, and measures at least one of the light quantity and the light intensity (sometimes referred to as light quantity/light intensity) of the transmitted light having a single or a plurality of wavelengths. The absorptiometer 44 may obtain a quantitative value such as a concentration by a predetermined calculation based on the measured value. The absorbance photometer 44 outputs a signal containing the measured or calculated value.

The scattering photometer 45 irradiates light from the light source to the reaction solution 3 in the reaction container 25 at the second measurement position. At this time, the scattered light meter 45 detects scattered light obtained from the reaction solution 3 by the light receiving unit, and measures at least one of the light amount and the light intensity of the scattered light (light amount/light intensity). The scattering photometer 45 may obtain a quantitative value such as a concentration by a predetermined calculation based on the measured value. The scattering photometer 45 outputs a signal containing the measured or calculated value.

The cleaning unit 46 cleans the reaction containers 25 arranged at the cleaning position on the reaction disk 20. The cleaning unit 46 discharges the remaining reaction solution 3 from the reaction vessel 25 in which the measurement and analysis have been completed, and cleans the reaction vessel 25. The reaction vessel 25 after being cleaned can be reused. That is, the next sample 2 is dispensed again from the sample dispensing mechanism 41 and the next reagent 4 is dispensed from the reagent dispensing mechanism 42 into the reaction vessel 25.

[ analysis control section ]

Fig. 2 mainly shows a functional block configuration of the analysis control unit 50 in the configuration of fig. 1. The analysis control unit 50 controls the entire automatic analysis device 1 and the automatic analysis procedure, and controls analysis including measurement. The analysis control unit 50 is connected to the interface circuit 101, the output unit 71, the input unit 72, and the like. The analysis control unit 50 outputs (i.e., displays a screen, outputs a voice, etc.) to the output unit 71. The analysis control unit 50 receives an input (i.e., an operation performed by a user) from the input unit 72. The user of the automatic analyzer 1 performs operations and tasks related to clinical examinations via the output unit 71 and the input unit 72. The output unit 71 includes an output device such as a display device. The analysis control unit 50 controls the output thereof to display information such as the measurement result and the data alarm on the display screen of the display device. The output unit 71 may include a sound output device or may emit an alarm sound. The input unit 72 includes an input device such as a keyboard, a mouse, or an operation panel including operation buttons.

The computer 100 and the analysis control unit 50 can be integrally realized by a PC as an example of mounting, but may be mounted without being limited thereto. The analysis control unit 50 executes processing in accordance with a program read from the storage unit 70 by a microprocessor such as a CPU of a PC, for example. This enables the measurement unit 51 and other components to be realized. The analysis control unit 50 includes, as functional blocks that can be realized by software program processing or the like: the measurement unit 51, the analysis unit 52, the control unit 53, the constant temperature fluid control unit 54, the data storage unit 55, the simultaneous analysis determination unit 56, the automatic re-inspection determination unit 57, the measurement-time abnormality detection unit 58, the priority output determination unit 59, and the 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, an automatic review function, and the like, which will be described later. The analysis control unit 50 performs operation control processing, measurement data control processing, and the like of each mechanism and part of the automatic analyzer 1 as analysis processing for the specimen 2 having the analysis request mainly by the measurement unit 51, the analysis unit 52, and the control unit 53.

The data storage unit 55 is configured using a 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, automatic review information, and the like.

The measurement unit 51 receives signals including measurement values of the absorption photometer 44 and the scattering photometer 45, which are two photometers, and performs measurement processing. The measurement process includes predetermined calculations. The calculation is for example: the concentration of the target component substance is calculated based on the amount of light/intensity of light as the measurement value, or the intensity of light is calculated from the amount of light as the measurement value. The measurement unit 51 stores the measurement result (measurement value, calculation value) as measurement data in the data storage unit 55.

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 process is, for example, to calculate the concentration from the light intensity of the measurement data using a calibration curve. Alternatively, the analysis process is to calculate the component amount of the target component substance using the calculated concentration. The analysis unit 52 determines the presence or absence of an abnormality or the like at the time of measurement for each measurement result of the photometer, and if the abnormality or the like exists, the measurement result is given a data alarm indicating the abnormality or the like. The determination by the analysis unit 52 is independent determination for each photometer. When determining an abnormality or the like at the time of measurement, the analysis unit 52 refers to the control result information or the like stored in the data storage unit 55 by the control unit 53 to perform the determination.

The control unit 53 is a drive control unit that performs drive control of each mechanism according to an automatic analysis procedure. The control unit 53 performs drive control based on analysis request information of the target object 2 stored in the data storage unit 55, and the like. The control unit 53 controls the respective portions including the drive unit 12, the drive unit 22, the drive unit 32, the sample dispensing mechanism 41, the reagent dispensing mechanism 42, the absorption photometer 44, the scattering photometer 45, and the like. For example, the drive unit 12 drives the detection body disk 10 to rotate under the control of the control unit 53. Further, for example, the control unit 53 controls the drive of the sample dispensing mechanism 41 to perform a sample dispensing operation. For example, the control unit 53 controls the driving of the absorption photometer 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 the result in the data storage unit 55. In addition, when an abnormality or the like exists in the mechanism, or when an abnormality or the like is detected in the mechanism, the control result information includes information indicating the abnormality or the like.

The control unit 53 rotates each tray such as the detector tray 10, and disposes a container such as the target sample cup 15 at a predetermined position of each tray. By the rotation of the disc, each container repeats the rotational movement and the standstill by a unit distance on the circumference. The control unit 53 controls the operations of the respective disks, the sample dispensing mechanism 41, and the like, to prepare the reaction liquids 3 of the plurality of samples 2 in the plurality of reaction containers 25 on the reaction disk 20. In the case of simultaneous analysis, the controller 53 measures the light amount and the light intensity of the reaction solution 3 in the target reaction well 25 disposed at each measurement position on the reaction disk 20 by the control of the two photometers.

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.

The simultaneous analysis determination unit 56 performs determination for output control based on the measurement results of the two photometers during simultaneous analysis and a data alarm. In other words, the automatic re-inspection determining unit 57 is an abnormality determining unit that determines whether or not automatic re-inspection is necessary based on an abnormality or the like at the time of measurement with respect to the measurement result using one type of photometer. The measurement-time abnormality detecting unit 58 determines and detects whether or not an abnormality or the like indicated by a data alarm has occurred in the measurement results of the two photometers. The priority output determination unit 59 determines the measurement result of the priority output or the like based on a predetermined determination or a determination of the priority output setting with respect to the measurement results of the two photometers. The priority output alarm determination unit 60 determines a data alarm or the like to be output in priority among two types of data alarms included in the two types of measurement results.

[ Properties of photometer ]

Fig. 3 shows characteristics of an absorption photometer 44 and a scattering photometer 45, which are two photometers used in embodiment 1. As shown in FIG. 3, the quantitative range characteristics of the two photometers are different. In the graph of fig. 3, the horizontal axis represents the theoretical value (unit [ U/mL ]) and the vertical axis represents the measured value (unit [ U/mL ]) of each photometer with respect to the concentration of the target component substance in the target specimen. The area of the dashed line indicates the quantitative range of the first photometer, absorbance photometer 44. The dotted area indicates the quantitative range of the scattering photometer 45, which is the second photometer. The range 301 represents the normal output range in the quantitative range of the absorbance photometer 44. In other words, the normal output range indicates a range in which measurement and quantification can be appropriately performed. The range 302 represents the normal output range in the quantitative range of the scatterometer 45. The range 303 represents the repeat range of the two ranges 301, 302. The range 303 is a range in which the measurement result of the photometer of an optional kind can be basically used. The analysis control unit 50 is preset with an appropriate quantitative range for each photometer for use in output control. That is, ranges corresponding to the ranges 301, 302, 303, and the like are set (at least, upper limit values, lower limit values, and the like defining the ranges are set).

The range 301 of the absorption photometer 44 has a shape having a narrow width (a range of measured values with respect to theoretical values) with the reference straight line 300 as a center, and exhibits a linear characteristic. The range of values smaller than the range 301 has a shape having a wider width than the reference straight line 300, and has a characteristic of a large error. The range 302 of the scattering photometer 45 has a substantially narrow width shape centered on the reference straight line 300, and exhibits linear characteristics. The range having a value larger than the range 302 is a shape having a wider width in a region located lower than the reference straight line 300, and has a characteristic of a large error.

When two kinds of measurement results are obtained in the simultaneous analysis, the analysis control unit 50 selects a measurement result to be output based on the determination of the above-described characteristics (corresponding ranges) as described below. This determination is included in the specification of the correspondence table described later. The concentration of the target component substance is preferably determined more accurately in a relatively high concentration range (for example, in a range of about 10U/mL or more) by the absorption spectrophotometer 44 as indicated by a range 301. Therefore, the measurement result of the absorption photometer 44 is selected as an output. Conversely, in a relatively low concentration range (for example, a range of about 5U/mL or less), the scattering photometer 45 is more accurate in one of the quantitative determinations as shown in the range 302, and is suitable. Therefore, the measurement result of the scattering photometer 45 is selected as an output.

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

[ priority output setting ]

The priority output setting is a setting for using the absorption photometer 44 and the scattering photometer 45 with priority and outputting a measurement result and a data alarm of which photometer. The automatic analyzer 1 has a priority output setting function, performs priority output setting by a service engineer as default setting for installation, and stores corresponding priority output setting information. As the priority output setting information, which photometer is prioritized is set as a value in a predetermined format such as a priority order. The priority output setting information can be set in advance by the input unit 72, for example. The automatic analyzer 1 is also set with an on state or an off state of the priority output setting function, and this state can be variably set by an operator or a user. If the priority output setting function is to be disabled, the setting may be made to the off state. As described later, the priority output determination is performed based on the priority output setting information in the on state, and the priority output determination is not performed in the off state.

[ Simultaneous light absorption and scattering analysis function ]

The automatic analyzer 1 has a simultaneous analysis function of simultaneously performing measurement and analysis on the sample 2 using two types of photometers based on the characteristics of the two types of photometers. The automatic analyzer 1 performs light absorption/scattering simultaneous analysis when receiving a simultaneous analysis request for a target component substance of the specimen 2. In this function, a target component substance of the same test item of the same specimen 2 to be tested is measured by the absorption photometer 44 and the scattered photometer 45, and two kinds of measurement results are obtained. At this time, the automatic analyzer 1 uses two types of photometers to substantially simultaneously measure the reaction progress of the reaction solution 3 in the reaction container 25 of the target specimen 2. Further, since each measurement is performed at two measurement positions on the reaction disk 20, there is a predetermined time difference. The reaction process is a continuous measurement process in which the reaction container 25 is stationary at the measurement position of the photometer for a predetermined time, and includes a plurality of predetermined measurements for each time on the time axis.

Based on the above characteristics, the automatic analyzer 1 selects an appropriate measurement result from two measurement results in the case of simultaneous analysis. When the concentration falls within a relatively high concentration range (for example, a range obtained by removing the range 303 from the range 301), the automatic analyzer 1 selects the measurement result of the absorption photometer 44 and performs absorption analysis. When the concentration falls within a relatively low concentration range (for example, a range obtained by removing the range 303 from the range 302), the automatic analyzer 1 selects the measurement result of the scattering photometer 45 and performs scattered light analysis. This makes it possible to perform measurement and analysis with high accuracy over a wide concentration range including high and low concentrations.

[ automatic review function ]

The automatic analyzer 1 has an automatic review function of controlling to automatically perform review based on a predetermined judgment when an abnormality or the like at the time of measurement is detected. In embodiment 1, the automatic review function is a function that performs control by associating a data alarm function and an output control function. The output control function includes a function of selecting automatic review information for the automatic review function.

As the abnormality at the time of measurement, for example, in the case of a slight abnormality such as an abnormality in the concentration of the sample, it is highly likely that an appropriate result can be obtained by performing re-measurement after coping with dilution of the sample 2, a decrease or increase in the amount of the sample, or the like. Therefore, in the automatic analysis device 1, when an abnormality or the like at the time of measurement is detected, the automatic re-inspection information is selected as a part of the output, based on the combination of the corresponding data alarms, whether or not the automatic re-inspection is necessary, the re-measurement condition at the time of necessity, or the like. The automatic analyzer 1 automatically controls re-measurement based on the automatic re-inspection information by the automatic re-inspection function, and outputs the re-inspection result.

In addition, when performing the automatic review, the automatic analyzer 1 collects a new sample 2 from the sample cup 15 in which the target sample 2 is stored, based on the automatic review request information and the automatic review information, and performs the reprocessing including the dispensing into the reaction container 25. The automatic analyzer 1 re-measures the reaction container 25 using a selected type of photometer. In addition, when a data alarm is further added to the result of the automatic review, the output selection corresponding to the combination of the data alarms may be applied in the same manner, or an inapplicable mode may be adopted.

[ data alarm function ]

The automatic analyzer 1 has a data alarm function of attaching a data alarm indicating a detected abnormality or the like to a measurement result of the photometer. When performing simultaneous analysis, the automatic analyzer 1 also notes a data alarm for each measurement result of the two photometers in response to detection of an abnormality or the like. In particular, when an abnormality or the like occurs during measurement by the absorption photometer 44, the analysis unit 52 adds a first data alarm indicating the abnormality or the like to the first measurement result of the absorption photometer 44. When an abnormality or the like occurs during measurement by the scattering photometer 45, the analysis unit 52 adds a second data alarm indicating the abnormality or the like to the second measurement result by the scattering photometer 45. Analysis data including the measurement result with the data alarm is stored in the data storage unit 55.

[ output control function ]

In the case where there is an abnormality or the like at the time of the measurement, there is a possibility that a data alarm is added to the measurement results of all (both) of the plurality of (two types of) photometers. The automatic analyzer 1 has an output control function of selecting a measurement result, a data alarm, and the like to be output in accordance with a combination of the data alarms in the above-described case. The output control function includes a function of controlling the automatic review function, and includes a function of selecting automatic review information to be output.

[ examples of abnormalities and the like in measurement ]

The following examples are given of abnormalities, errors, and the like that may occur in an automatic analyzer. Examples of the abnormality of the mechanism include a shortage of the amount of the sample, a dispensing error due to a clogging of a flow path of fibrin contained in the sample 2, and an abnormality of a component of the sample 2. As an example of the abnormality of the component of the sample 2, a case where the sample concentration is abnormal and the concentration of the sample 2 is out of the quantitative range of the photometer may be mentioned. That is, the concentration of the sample 2 may be excessively high or excessively low compared to the quantitative range of the photometer. Further, the red color of the specimen 2 may change due to elution of blood cell components, and turbidity of the specimen 2 may be observed in a dyslipidemic patient.

[ data alarm ]

Fig. 4 shows definitions in the form of a table regarding the classification of various data alarms that may be output by the automatic analysis device 1 in response to abnormalities, errors, and the like that may occur. First, various abnormalities and data alarms will be described below. In general, automatic analyzers are roughly classified into the following two as technical means for calling the attention of a user based on abnormalities, errors, and the like that occur in measurement and analysis.

The first means is a technique of outputting measurement results by adding a data alarm. In this technique, identification information indicating normality or abnormality and predetermined information indicating a type of abnormality or the like in the case of abnormality are attached as a data alarm to each measurement result of a target component substance for which one or more test items exist for each specimen. Examples of the information indicating the type of the abnormality or the like include an identification code, a flag, and a description.

When information on the measurement result with the data alarm is output from the automatic analyzer, the user can recognize the type of the generated abnormality or the like by viewing and confirming the information on the display screen. Then, the user performs a response operation or the like based on the abnormality or the like indicated by the data alarm. For example, the user performs a response operation based on an identification code of the data alarm, an operation manual (guidance on a display screen, not limited to paper) of the automatic analyzer, and the like. The handling work is a work or operation for improving the state of the automatic analyzer such as an abnormality so as to return to a normal state, and bringing the state into a state in which the re-inspection can be performed.

The second means is a technique of outputting a system alarm. In this technique, an abnormality related to the entire automatic analyzer, such as a temperature abnormality or a mechanism abnormality, is set as a system alarm, and an alarm (e.g., a voice output) is given to a user. In addition, the system alarm may be displayed on a screen as a data alarm to which system alarm identification information is added, as one of the data alarms.

The automatic analyzer 1 according to embodiment 1 has at least a data alarm function corresponding to the first means. As shown in fig. 4, the automatic analyzer 1 has a plurality of data alarms defined in advance according to the type of abnormality or the like. In embodiment 1, the plurality of types of data alarms are roughly divided into three groups and levels as shown below. In the table of fig. 4, (a) indicates a high-level and first-group data alarm, (B) indicates a medium-level and second-group data alarm, and (C) indicates a low-level and third-group data alarm. In addition, high, medium, and low are relative.

(A) First group and high level: the first group and the high level correspond to a case where a recheck is required to obtain an accurate measurement result due to the presence of an abnormality or the like, but for this reason, the recheck can be performed only after the user improves the state. The improvement of the condition includes: the improvement of the specimen 2 and the reagent 4, that is, the improvement of the reaction liquid 3 in the reaction container 25, and the improvement of the state of mechanisms such as a dispensing mechanism and a cleaning mechanism. The improvement in the state is, for example: the state is changed to a state in which the amount of the sample 2 is decreased when the amount of the sample in the reaction solution 3 in the reaction vessel 25 is large, or to a state in which the amount of the sample 2 is increased when the amount of the sample is small. In this case, the automatic analyzer 1 outputs a high-level data alarm as output control so that the user is prompted to perform a response operation or operation including an improvement state without immediately performing automatic review. The automatic analyzer 1 performs automatic review after the state has been improved.

(B) Second group and medium grade: the second group and the middle rank correspond to a case where a recheck is necessary due to the presence of an abnormality or the like, and therefore the recheck can be performed without an operation by the user. This case corresponds to a case where it is estimated that a good measurement result can be obtained by controlling the re-examination of the re-measurement conditions. In this case, the automatic analyzer 1 sets, as the re-measurement condition, for example, the reagent amount of the reaction solution 3 to the same condition as that in the previous measurement (that is, when the measurement in which abnormality or the like is detected), an increment condition, or a decrement condition. In this case, the automatic analyzer 1 outputs a medium-level data alarm, and attempts to obtain a good measurement result by performing re-measurement under the re-measurement condition.

(C) Third category and low level: the third group and the lower rank correspond to the case where the obtained measurement result is not necessary to be measured again, and the measurement result can be processed as a reference value and output. In this case, the automatic analysis device 1 outputs a low-level data alarm.

The groups and levels of data alarms described above may be further defined as including various data alarms as described below. Each data alarm is described and attached with an identification code or the like. Examples of identification codes may be represented by "a 1", "B1", and the like.

(A) The first group and high level data alarms are, for example, the following 5 data alarms. Fig. 4 (a) shows a corresponding table portion. In each line of the table, "a 1" in parentheses and the like represent the identification code of the data alarm. In this example, the following are provided: detection starvation alarm a1, reagent starvation alarm a2, alarm A3 of detected clogging, detergent starvation alarm a4, photometer anomaly alarm a 5.

(1) The sample shortage alarm a1 is a data alarm generated when the amount of the sample 2 in the reaction liquid 3 in the sample cup 15 or the reaction container 25 is determined to be insufficient by a liquid level detection sensor or the like provided in the sample dispensing mechanism 41.

(2) The reagent shortage alarm a2 is a data alarm generated when it is determined that the amount of the reagent 4 in the reaction solution 3 in the reagent bottle 35 or the reaction container 25 is insufficient by a liquid level detection sensor or the like provided in the reagent dispensing mechanism 42.

(3) The alarm a3 for detecting a blockage is a data alarm generated when a blockage occurs in the flow path, such as when a foreign substance is mixed into the dispensing nozzle when the sample 2 is aspirated, which is determined by a pressure sensor or the like provided in the sample dispensing mechanism 41.

(4) The detergent shortage alarm a4 is a data alarm generated by shortage of detergent used for cleaning the dispensing nozzle and the reaction vessel 25 by the cleaning unit 46.

(5) The photometer abnormality alarm a5 is a data alarm generated when an abnormality is detected in the optical system, the substrate, and the like (the light source and the light receiving unit described above) in the absorption photometer 44 and the scattering photometer 45.

(B) The second group and the medium-level data alarms include (B-1) data alarms caused by abnormal reaction processes and (B-2) data alarms caused by abnormal concentrations of the test samples. For example, the following data alarms may be listed, respectively. Fig. 4 (B) shows the corresponding table portion.

(B-1) examples of the data alarm due to an abnormality in the reaction process include a cell blank abnormality alarm B1, an absorbance difference constant alarm B2, a scattered light intensity difference abnormality alarm B3, and an alarm which cannot be calculated.

(1) The cell blank abnormality alarm B1 is a data alarm generated when a cell blank value measured before the analysis of the target component substance in the specimen 2 deviates from a cell blank value previously stored in the automatic analyzer 1 or deviates from a cell blank value of another reaction vessel to be compared. The cell blank value is an optically measured value in a state where the reaction solution 3 is not injected into the reaction container 25.

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

(3) The scattered light intensity difference constant alarm B3 is a data alarm generated when the scattered light intensity difference or the rate of change in the scattered light intensity between specific measurement times has not reached a predetermined threshold value set in advance or has exceeded the threshold value in the reaction process of the target component substance measured by the scattered light photometer 45.

Since the data alarm generated due to the abnormality of the reaction process is less likely to cause an abnormality in the mechanism, the specimen 2, the reagent 4, and the like of the automatic analyzer 1, the data alarm corresponds to a case where the user does not need to perform the state improvement work and the automatic retest is possible. Therefore, in this case, the automatic analyzer 1 performs automatic re-inspection by performing output control so that the re-measurement condition is the same as that in the previous measurement in order to obtain an accurate measurement result.

(B-2) As the alarm generated by the abnormality of the sample concentration, there are a prozone alarm B4, an alarm B5 exceeding the upper limit of the quantitative range, an alarm of excessive absorbance/scattered light intensity, an alarm B6 exceeding the lower limit of the quantitative range, a repeat upper limit alarm, a repeat lower limit alarm, and the like.

(1) The prozone alarm B4 is a data alarm generated when the amount of antigen or antibody in the specimen 2 in the immunoassay is excessive. Known methods for determining this include a reaction rate ratio method and an antigen/antibody addition method. In the reaction rate ratio method, the ratio of the amount of change in absorbance (or the amount of change in scattered light intensity) per unit time at the initial stage of the reaction to the amount of change in absorbance (or the amount of change in scattered light intensity) at the end of the reaction is calculated from the reaction progress of the target component substance of the test item, and is compared with a previously set threshold value. In the antigen/antibody re-addition method, an antigen or an antibody is additionally added after the reaction is completed, and the amount of change in absorbance or the amount of change in scattered light intensity per unit time immediately after the addition is calculated and compared with a previously set threshold value.

(2) Alarm B5 exceeding the upper limit of the quantitative range is one of the alarms exceeding the technical limit, and is a data alarm generated in the case where the upper limit value of the appropriate 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 high relative to the quantitative range of the photometer, the data alarm is generated. For example, in fig. 3, when the concentration of the specimen 2 exceeds the upper limit value of the normal output range 301 in the case of measurement by the absorption photometer 44, the data alarm is generated.

(3) Alarm B6, which is out of the lower limit of the quantitative range, is one of the alarms out of the technical limit, and is a data alarm generated in the case where the lower limit value of the appropriate 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, the data alarm is generated. For example, in fig. 3, when the concentration of the specimen 2 is lower than the lower limit value of the normal output range 301 in the case of measurement by the absorption photometer 44, the data alarm is generated.

Normally, in the specimen 2 in which the abnormality corresponding to the prozone alarm B4 has occurred, the target component substance is excessively contained, and the alarm B5 exceeding the upper limit of the quantitative range is generated at the same time because the concentration is high. The front belt alarm B4 is generated in the case where the target component substance is excessive, as compared with the case of the alarm B5 exceeding the upper limit of the quantitative range. Therefore, when the two data alarms are generated at the same time, the automatic analyzer 1 selects only the front alarm B4 as the output control and outputs it. These data alarms correspond to a case where automatic retesting is possible because there is no abnormality in the mechanism, the specimen 2, the reagent 4, and the like of the automatic analyzer 1.

If the prozone alarm B4 or the alarm B5 exceeding the upper limit of the quantitative range is generated, it indicates that the concentration of the target component substance in the specimen 2 is too high. Therefore, in this case, the automatic analyzer 1 performs automatic retesting under the condition that the amount of the sample in the reaction solution 3 is reduced (or the sample 2 is diluted with the reagent 4). In addition, when alarm B6 exceeding the lower limit of the quantitative range is generated, it indicates that the concentration of the target component substance in specimen 2 is too low. Therefore, in this case, the automatic analyzer 1 performs automatic retesting under the condition that the amount of the analyte in the reaction solution 3 is increased.

(C) Examples of the data alarm of the third category and the lower level include the following two. Fig. 4 (C) shows a corresponding table portion. In this example, there are a serum information alarm C1, a reagent expiration date alarm C2, and a specimen left.

(1) The serum information alarm C1 is a data alarm generated when a coexisting substance that affects the analysis of a target component substance is mixed in the specimen 2 such as blood. The coexisting substances include lipids, hemoglobin, bilirubin, and the like. Specimen 2 (also referred to as abnormal specimen) mixed with these coexisting substances is called chyle, hemolysis, and yellow. Hemolysis (also referred to as red color change) and yellow color cause a color change of the specimen 2, and therefore, mainly have a large influence on the absorption photometer 44. Chyle causes a change in the turbidity of the detection body 2, and largely affects the scattering photometer 45. The serum information is information on the above-mentioned coexisting substances. The serum information is generally determined separately from the analysis of the target component substance of the test item by measuring the absorbance of the specimen 2 itself using the reagent 4 that does not react with the specimen 2 and light having a wavelength corresponding to each coexisting substance. The measured absorbances are compared with the previously set thresholds, and when the measured absorbances exceed the thresholds, a serum information alarm C1 is given.

(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.

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 the reference value as output control. In this case, only the replacement of the specimen 2 or the reagent 4 can improve the state. Therefore, the automatic analyzer 1 does not need automatic review and does not perform automatic review.

In the output control function of the automatic analyzer 1, for each measurement of the two photometers, basically one selected data alarm is added to the measurement result based on the detection of an abnormality or the like, the definition of the above-described data alarm, and a predetermined determination by the analysis control unit 50 (particularly, the analysis unit 52). The measurement result is temporarily stored in the data storage unit 55 together with information in which the data alarm is recorded. The analysis and determination unit 56 and other units perform output control by referring to the information in the data storage unit 55.

Depending on the type of abnormality or the like, a plurality of data alarms may be candidates for additional notes with respect to the measurement result of one photometer. In this case, the automatic analyzer 1 selects one data alarm to be added based on the previous setting and the predetermined determination. The setting is a design matter of the data alarm function. For example, as a definition of a data alarm in advance, importance and priority are set between a plurality of types of data alarms (corresponding to an abnormality, etc.). Although not shown in fig. 4, a priority number may be set for each data alarm, for example. The analysis unit 52 selects the data alarm with the highest priority from among the plurality of candidate data alarms. In addition, the automatic analyzer according to the modified example may be configured not to have the priority setting as described above, and may be configured to include a plurality of data alarms in one measurement result.

In the above, although some specific examples have been described for the three-level data alarm and the corresponding abnormality, the present invention is not limited thereto, and the present invention is also applicable to other various abnormalities and data alarms. The table of fig. 4 also shows examples of other types of data alarms to which identification codes are not added, and although they are not used for output control in the embodiment, they can be used in other embodiments as well.

[ analysis treatment (1) ]

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

The measurement unit 51 measures the amount of light and the intensity of light with respect to the target specimen 2 for each type of photometer based on a measurement value or a calculation value included in a signal from the photometer. The measurement unit 51 obtains the amount and intensity of transmitted light of the reaction solution 3 in the reaction vessel 25 from which the measurement value is obtained, based on the measurement value from the absorption photometer 44. The measurement unit 51 obtains the amount and intensity of scattered light of the reaction solution 3 in the reaction vessel 25, which has obtained the measurement value, based on the measurement value from the scattered light meter 45. For example, the measurement unit 51 calculates the light intensity based on the amount of transmitted light or scattered light as the measurement value. Then, the measurement unit 51 stores the information of the light intensity in the data storage unit 55 as measurement data associated with information of the target reaction vessel 25 into which the target specimen 2 is dispensed or analysis request information of the specimen 2. The measurement unit 51 is not limited to the light intensity, and may measure and calculate other parameters. The measurement data includes information on the reaction process measured by the photometer (i.e., a measurement value at each measurement time). The analysis request information includes information on the target specimen 2, the reagent 4, and the like.

The analysis unit 52 analyzes the target component substance of the specimen 2 in the reaction solution 3 to be analyzed with reference to the information based on the measurement data of the measurement unit 51, and obtains at least one of the concentration or the component amount of the target component substance ("concentration/component amount"). The analysis unit 52 reads the light quantity/light intensity of the transmitted light or the light quantity/light intensity of the scattered light in the measurement data, and determines the concentration of the target component substance. For example, the analysis unit 52 refers to the light intensity and also refers to the information on the calibration curve, and calculates the concentration of the target component substance based on the light intensity. At this time, the analysis unit 52 converts the light intensity into the concentration using a calibration curve prepared in advance corresponding to the reagent 4 used in the reaction solution 3. When the absorption spectrophotometer 44 is used, the analysis unit 52 converts the intensity of transmitted light into the concentration of the target component substance using a calibration line for the absorption spectrophotometer 44. When the scattering photometer 45 is used, the analyzing unit 52 converts the intensity of the scattered light into the concentration of the target component substance using a calibration line for the scattering photometer 45.

The calibration curve indicates the relationship between the concentration of each target component substance and the amount of light/intensity of transmitted light or scattered light, which is obtained using a specimen such as a standard substance containing the target component substance at a known concentration. In advance, the data storage unit 55 stores calibration curve data of the reagents 4 in the respective reagent bottles 35 of the reagent disk 30.

The analysis 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 specimen 2 or the information of the analysis request. In the embodiment, the concentration of the target component substance is mainly treated as the measurement result. The measurement result may be referred to as an analysis result, or the like.

In the analysis, the analysis unit 52 determines whether or not an abnormality, an error, or the like has occurred in the measurement of the target specimen 2, based on the reaction process measured by each photometer, the analyzed concentration, analysis parameter information set in advance, and the like. Examples of the abnormality and the like are as described above. When it is determined that an abnormality or the like occurs at the time of measurement, the analysis unit 52 adds a data alarm corresponding to the type of the abnormality or the like to the measurement result including the concentration corresponding to the type of the photometer, and stores the data alarm as analysis data in the data storage unit 55. When a data alarm is added, the analysis unit 52 adds a data alarm selected according to the classification definition shown in fig. 4 and a predetermined decision.

During the analysis operation of the target specimen 2, the control unit 53 controls the sites including the specimen tray 10, the specimen dispensing mechanism 41, and each mechanism of each photometer, and monitors and determines the occurrence of an abnormality, an error, or the like at these sites. When a mechanism abnormality or the like is detected by the control unit 52, control result information including information indicating the abnormality or the like 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 an abnormality or the like at the time of measurement and the type of the abnormality or the like based on the measurement data and the control result information.

As described above, as a first stage, data including the measurement result is stored in the data storage unit 55 as an analysis result by the measurement unit 51, the analysis unit 52, and the control unit 53. When there is an abnormality in measurement or the like, data in which a data alarm is added to the measurement result can be obtained. In the case of simultaneous analysis, data are obtained for each type of photometer. Then, as a second stage, the analysis control unit 50 performs an output control process of the analysis result with respect to the target specimen 2 as follows. The analysis control unit 50 performs the second stage of processing by the simultaneous analysis determination unit 56, the automatic review determination unit 57, the measurement-time abnormality detection unit 58, the priority output determination unit 59, the priority output error determination unit 60, and the like. The analysis control unit 50 uses these to output the analysis result to the display screen of the output unit 71.

[ analysis treatment (2) ]

Next, the output control processing in the second stage will be described with reference to fig. 2 and the like. In the case of simultaneous analysis, the analysis controller 50 outputs analysis data including measurement results of each of the two photometers to the simultaneous analysis determining unit 56 via the data storage unit 55. The analysis determining unit 56 refers to the analysis data from the data storage unit 55. The analysis control unit 50 also causes the automatic review determination unit 57, the measurement-time abnormality detection unit 58, the priority output determination unit 59, the priority output error determination unit 60, and the like to perform processing as necessary.

When the results of the simultaneous analysis are output to the user via the display screen of the output unit 71, the analysis control unit 50 selects an appropriate one of the two measurement results depending on the concentration of the target component substance, based on the above-described characteristics, by the simultaneous analysis determination unit 56. When one or more data alarms are added to the two measurement results, the analysis control unit 50 performs output control processing for selecting the output measurement result, data alarm, and automatic review information based on the combination of the data alarms as described below.

[ correspondence table ]

Fig. 5 to 8 show correspondence tables defining association between combinations of a plurality of data alarms for output control and outputs in the automatic analysis device 1. In particular, a correspondence table is shown for the aforementioned mid-level data alarms. The analysis control unit 50 and the output control function perform predetermined output control processing according to the correspondence table. In embodiment 1, this output control process is installed as a software program process as in a process flow described later. The correspondence table may be held as a table to be installed (that is, determination may be made by referring to the table), or may be installed as a process flow, and the table and the like may be omitted.

Fig. 5 shows a first example of the association between the combination of the aforementioned middle-level data alarms and the output, as the first part of the correspondence table. FIG. 5A shows a combination of data alarms generated by abnormality of the reaction process of (B-1). The first column "absorbance" of the correspondence table shows a first data alarm relating to the first measurement result using the absorbance photometer 44. The second column "scatter" shows a second data alarm relating to a second measurement result using the scatter photometer 45. That is, the groups of the first column and the second column represent a combination of two data alarms. The third column "output" of the correspondence table indicates, in particular, the selection of the measurement result as the output content selected in the case of the group of the first column and the second column. The fourth column "review" of the correspondence table shows whether or not the selected one, i.e., the automatic review by the automatic review function, is required (presence or absence). Column 5 "condition" of the correspondence table shows an automatic review condition (i.e., a review condition, etc.) in the case where a selected one, i.e., an automatic review request, is made.

In fig. 5 (a), the values of "absorption" in the first row and "scattering" in the second row are 1. "absorbance difference abnormality" (B2)/"scattered light intensity difference abnormality" (B3), 2. "cell blank abnormality" (B1), and 3. "calculable", according to fig. 4. As a combination of these three values, there is a combination of 3 × 3 ═ 9. Here, the absorbance difference constant alarm B2 and the scattered light intensity difference abnormal alarm B3 are combined into one alarm, but a combination of these alarms may be further considered. The values of the third column "output", the fourth column "review", and the 5 th column "condition" are defined for each row of each combination. As values of the third column "output", there are three values of "absorption" (value 1), "scattering" (value 2), and "priority" (value 3). "absorption" (value 1) indicates the first measurement result and the first data alarm on the side of selecting the absorption photometer 44. "scatter" (value 2) indicates the second measurement result and the second data alarm of the selected scattering photometer 45. "priority" (value 3) indicates that one of the two measurement results and the data alarm is selected according to the determination of the priority output setting. As the values of the fourth column "review", there are two values of "present" (value 1) and "absent" (value 2). "having" (value 1) means that automatic review is required (if required). "none" (value 2) means no (no) automatic review is required. As the values of the "condition" in the 5 th column, there are three values of "same" (value 1), "decrement" (value 2), and "increment" (value 3). The "same" (value 1) indicates the same conditions (re-measurement conditions, etc.) as in the previous measurement. "reduction" (value 2) indicates a change to a condition in which the amount of the specimen 2 is reduced from the condition in the previous measurement. The "increment" (value 3) indicates a condition in which the amount of the specimen 2 is increased with respect to the condition in the previous measurement.

As an example, in the combination (1-1) in the first row, the data alarm groups of "light absorption" - "scattering" are "B2/B3" - "B2/B3", "output" ═ priority "(value 3)," recheck "-" present "(value 1), and" condition "-" same "(value 1). In these cases, the analysis controller 50 selects and outputs the measurement result of one photometer and the data alarm (B2/B3) as the automatic review information for requesting the automatic review under the same conditions as the previous time, based on the determination of the priority output setting. The same output is obtained by combining other rows.

Similarly, fig. 5 (B) shows a combination of data alarms generated particularly by (B-2) abnormality in the specimen concentration. In fig. 5 (B), the values of "absorbed light" in the first row and "scattered light" in the second row are 1. "excessive absorbance/scattered light intensity", 2. "prozone" (B4), 3. "upper limit of quantitative range" (B5), and 4. "lower limit of quantitative range" (B6), respectively, according to fig. 4. As a combination of these four values, there is a combination of 4 × 4 ═ 16.

As an example, from the fourth line to the eighth line, the data alarm of "light absorption" is four combinations of the top band alarms B4, and the outputs are selected as "output" for "light absorption" (value 1), "recheck" for "presence" (value 1), and "condition" for "decrement" (value 2). In these cases, the analysis control unit 50 selects and outputs the first measurement result and the second data alarm (B4) of the absorption photometer 44 as the automatic review information for requesting the automatic review under the condition of the amount of decrease from the previous condition. From the ninth line to the twelfth line, it is the case that the data alarm of "light absorption" is four combinations of the alarms B5 exceeding the upper limit of the quantitative range, and the output selection is the same. From the thirteenth row to the sixteenth row, this is the case for a "light absorbing" data alarm, four combinations of alarms B6 that exceed the lower limit of the quantitative range. In the combination of the thirteenth line, the fourteenth line, and the fifteenth line, the output is selected from "output" with "light absorption" (value 1), "recheck" with "(value 1), and" condition "with" increment "(value 3). In these cases, the analysis control unit 50 selects and outputs the first measurement result of the absorption photometer 44 and the first data alarm (B6) as the automatic review information for requesting the automatic review under the condition of the previous increase in the condition. In the combination in the sixteenth row, as the output selection, there are "output" (value 2), "re-check" (value 1), and "condition" (value 3). In this case, the analysis control unit 50 selects and outputs the second measurement result of the scattering photometer 45 and the second data alarm (B6) as the automatic review information for requesting the automatic review under the condition that the amount of the second measurement result is increased from the previous condition.

FIG. 6 shows, as the second part of the correspondence table, a combination of (B-1) reaction process abnormality and (B-2) detection body concentration abnormality in the medium-level data alarm. Here, as the values of the first row "light absorption" and the second row "scattering", there are 7 kinds of values of "B2/B3", "B1", "not calculable", "absorbance/scattered light intensity excessive", "B4", "B5" and "B6" described above.

As an example, from the first row to the fourth row, the data alarm of "light absorption" is "B2/B3" in the abnormality of (B-1) reaction process, and the data alarm of "scattering" is four combinations of (B-2) abnormality of detection body concentration. In the first to third rows, "output" is "light absorption" (value 1), "recheck" is "presence" (value 1), and "condition" is "same" (value 1) are selected as outputs. In the fourth row, as output choices, "output" is "scatter" (value 2), "re-check" is "present" (value 1), and "condition" is "increment" (value 3). The data alarm (B-1) for "light absorption" from the fifth line to the eighth line is "B1" in the abnormality of the reaction process, and the data alarm for "scattering" is (B-2) in the case of four combinations of the abnormality of the detection body concentration. The output selection is the same as the first to fourth rows.

For example, in the sixteenth to eighteenth rows, the "light absorption" data alarm is the (B-2) prozone alarm B4 in the detection concentration abnormality, and the "scattering" data alarm is the (B-1) three combinations of reaction process abnormalities. In the sixteenth to eighteenth rows, as the output selection, "output" means "light absorption" (value 1), "recheck" means "presence" (value 1), and "condition" means "decrement" (value 2). For example, from the nineteenth line to the twentieth line, the "light absorption" data alarm is (B-2) the alarm B5 exceeding the upper limit of the quantitative range among the abnormalities in the specimen concentration, and the "scattering" data alarm is (B-1) three combinations of abnormalities in the reaction process. In the nineteenth to twentieth lines, the selection of outputs includes "output" for "light absorption" (value 1), "retest" for "presence" (value 1), and "condition" for "decrement" (value 2). For example, from the twenty-second line to the twenty-fourth line, the "light absorption" data alarm is (B-2) the alarm B6 that exceeds the lower limit of the quantitative range among the abnormalities in the specimen concentration, and the "scattering" data alarm is a case of three combinations of (B-1) abnormalities in the reaction process. In the twenty-second to twenty-fourth rows, "output" is "light absorption" (value 1), "recheck" is "presence" (value 1), and "condition" is "increment" (value 3) are selected as outputs.

In FIG. 7, as the third part in the correspondence table, a part of a combination of a middle-level (B-1) data alarm reflecting a process abnormality and a low-level data alarm is shown. Here, there are 6 kinds of values of "B2/B3", "B1", "not calculable", "serum information (C1)", "specimen remaining", and "expiration of reagent expiration date (C2)" as described above as values of "light absorption" in the first row and "scattering" in the second row.

As an example, from the first row to the fourth row, the data alarm of "light absorption" is the case of three combinations of three of (B-1) data alarms of "B2/B3" and "scattering" data alarms of low rank in the reaction process abnormality. In the first to third rows, "output" — "scatter" (value 2), "review" — "no" (value 2), and "condition" - "(no value) are selected as outputs. In these cases, the analysis control unit 50 selects and outputs the second measurement result of the scattering photometer 45 and the second data alarm (low level), and does not make the automatic review request. Similarly, the fourth to sixth rows are cases where the "light absorption" data alarm is "B4" and the "scattering" data alarm is three combinations of three at a low level. The same output selection is also used in these cases.

In the case of the data alarm of "light absorption" being a low-level serum information alarm (C1) and the data alarm of "scattering" being three combinations of three in which the reaction process is abnormal (B-1), the tenth to twelfth rows are shown. In the tenth to twelfth rows, "output" — "light absorption" (value 1), "recheck" — "no" (value 2), and "condition" - "(no value) are selected as outputs. In these cases, the analysis control unit 50 selects and outputs the first measurement result of the absorption photometer 44 and the first data alarm (low level), and does not make the automatic review request. Similarly, the sixteenth to eighteenth rows represent the case where the data alarm of "light absorption" is the reagent expiration alarm C2 and the data alarm of "scattering" is three combinations of three of (B-1) reaction process abnormalities. These cases are also the same output options.

Fig. 8 shows, as the fourth section of the correspondence table, a section in which a data alarm of a medium-level (B-2) specimen concentration abnormality and a data alarm of a low-level are combined. Here, as values of the first row "light absorption" and the second row "scattering", there are 7 kinds of values of "absorbance/scattered light intensity is excessive", "B4", "B5", "B6", "serum information (C1)", "specimen remaining", and "reagent expiration date (C2)", which are described above.

For example, in the first to fourth rows, the "light absorption" data alarm is (B-2) in the case of the detection concentration abnormality, the "absorbance/scattered light intensity is excessive, and the" scattering "data alarm is a lower-order three-way combination. In the first to third rows, "output" means "light absorption" (value 1), "recheck" means "presence" (value 1), and "condition" means "decrement" (value 2) are selected as outputs. Similarly, the fourth to sixth rows are cases where the "light absorption" data alarm is "B4" and the "scattering" data alarm is three combinations of three at a low level. The same output selection is also used in these cases. Similarly, the seventh to ninth rows are cases where the "light absorption" data alarm is "B5" and the "scattering" data alarm is three combinations of three at a low level. The same output selection is also used in these cases. Similarly, the tenth to twelfth rows are cases where the "light absorption" data alarm is "B6" and the "scattering" data alarm is three combinations of three at a low level. In these cases, as the output selection, there are "output" — "scatter" (value 2), "recheck" — "no" (value 2), and "condition" - ".

The data alarm of "light absorption" in the thirteenth to sixteenth rows is the serum information alarm C1 of low rank, and the data alarm of "scattering" is the case of four combinations of (B-2) four types of abnormal specimen concentration. In the thirteenth to fifteenth rows, "output" is "light absorption" (value 1), "recheck" is "no" (value 2), and "condition" - "are selected as the output. In the sixteenth row, as the output selection, "output" — "scatter" (value 2), "re-check" — "presence" (value 1), and "condition" — "increment" (value 3) are selected. Likewise, from the seventeenth row to the twentieth row, the same output is selected. Similarly, in the combination from row twenty to row twenty, the case where the data alarm that is "light absorption" is the low-ranked reagent expiration alarm C2, is the same output selection.

[ treatment procedure ]

Next, the flow of the output control process performed by the analysis control unit 50 of the automatic analyzer 1 will be described with reference to fig. 9 to 14.

[ (1) output control processing ]

Fig. 9 is a flowchart showing a first process of the analysis control unit 50. The first process is an output control process for selecting a measurement result to be output and a data alarm or the like using one or both of the two photometers. The present flow includes steps S201 to S210. The following description will be made in order of steps. In addition, a plurality of processing flows in fig. 9 and thereafter will be described as being divided into a plurality of flowcharts for illustration and description. These process flows are logically connected between steps, and can be understood as one process flow as a whole. That is, the entire CPU or the like of the analysis control unit 50 can be realized as one program.

(S201) the simultaneous analysis determination unit 56 checks whether the type of the analysis request to the target specimen 2 is a simultaneous analysis request. If the simultaneous analysis request is present (yes), the process proceeds to S204, and if the simultaneous analysis request is not present (no), the process proceeds to S202. The case where the simultaneous analysis request is not made corresponds to the case where a single analysis request (an absorption analysis request or a scattered light analysis request) is set to be made by one of the absorption photometer 44 and the scattered light photometer 45. Other forms of analysis requests may also exist. For example, it may be a "absorb 2 items while analyzing" request. The "simultaneous analysis of absorption 2 items" simultaneously measures and analyzes two kinds of target component substances with respect to the reaction solution 3 in the reaction vessel 25 of the same object 2 using only the absorption spectrophotometer 44.

(S202) in the case of a single analysis request, the simultaneous analysis determination unit 56 causes the output unit 71 to output all the data (including the measurement result and the data alarm) measured by the photometer of the requested party. As a result, the concentration as the measurement result, the data alarm added when there is an abnormality at the time of measurement, or the like is displayed as the result of the single analysis on the display screen of the output unit 71.

(S203) the automatic re-inspection determining unit 57 determines whether or not automatic re-inspection is necessary based on an abnormality or the like in the measurement with respect to the measurement result of the single analysis. The automatic review determination unit 57 determines that automatic review is not necessary when no data alarm is added to the measurement result or when a high-level or low-level data alarm is added to the measurement result. If not necessary (no), the automatic review request is not made, and the flow ends. When the measurement result includes a medium-level data alarm, the automatic review determination unit 57 determines that automatic review is necessary, and in such a case (if necessary), the process proceeds to S210.

(S210) the automatic review determination unit 57 makes an automatic review request under the automatic review condition corresponding to the type of the data alarm. That is, the automatic review determination unit 57 stores automatic review request information including the re-measurement conditions and the like in the data storage unit 55. The automatic review function of the analysis control unit 50 controls automatic review based on the automatic review request information.

On the other hand, when the simultaneous analysis is requested in S201, the simultaneous analysis determination unit 56 outputs all data including both the first measurement result using the absorption photometer 44 and the second measurement result using the scattering photometer 45 to the target specimen 2 for which the request is made, via the abnormality testing unit 58 during measurement, as described below. All the data are stored in the data storage unit 55 by the measurement unit 53 and the analysis unit 52.

(S204) the abnormality detector 58 determines whether or not a data alarm is included in the first measurement result and the second measurement result, which are the measurement results of the two photometers. That is, the measurement-time abnormality detecting unit 58 detects whether or not an abnormality or the like at the time of measurement indicated by the data alarm has occurred in each measurement result. As a result of this determination, the process proceeds to S207 only when there is an abnormality or the like in the first measurement result (a), and proceeds to S209 only when there is an abnormality or the like in the second measurement result (B). If, as a result of the determination, both the first measurement result and the second measurement result have an abnormality or the like (C), the routine proceeds to S205 (fig. 3). If, as a result of the determination, both the first measurement result and the second measurement result have no abnormality or the like (D), the routine proceeds to S206.

(S207) the abnormality detector 58 causes the output unit 71 to output all the data relating to the scattered light analysis including the second measurement result. As a result, on the display screen of the output unit 71, data including the concentration obtained by the scattering photometer 45 without abnormality or the like is preferentially output to the user as a result of the simultaneous analysis.

(S209) the abnormality detector 58 causes the output unit 71 to output all the data concerning the absorbance analysis including the first measurement result. Accordingly, data including the absence of abnormality of the concentration obtained by the absorption photometer 44 is preferentially output to the user on the display screen of the output unit 71.

(S205) the priority output alarm determination unit 60 performs a priority output alarm determination process (fig. 10) described later. This processing is, as an outline, processing for determining which data alarm is preferentially selected from among a first data alarm noted in the first measurement result and a second data alarm noted in the second measurement result to output.

(S206) the priority output determination unit 59 performs the priority output determination process on the first measurement result and the second measurement result, which are the measurement results of the two photometers. This processing is processing for determining which measurement result is preferentially selected from among the measurement results of the two photometers and outputting the selected measurement result. The priority output determination unit 59 refers to the priority output setting information set in advance of the analysis request from the data storage unit 55 at the time of this determination. For example, the priority output setting information is set as one of the parameters of the analysis request information. The priority output setting information includes, for example, a setting value of a priority output order indicating which of the first measurement result and the second measurement result is to be output with priority. For example, as the priority output order, a value of 1 indicates a setting of preferentially outputting the first measurement result ("light absorption priority setting"), and a value of 2 indicates a setting of preferentially outputting the second measurement result ("scattering priority setting"). Any preference setting outputs substantially only one photometer measurement. The priority output determination unit 59 selects one of the first measurement result and the second measurement result in accordance with the priority output setting information of the analysis request information.

In S206, if the priority output setting function is in the on state, if it is "scattering priority setting" (a), the process proceeds to S207, and if it is "light absorption priority setting" (B), the process proceeds to S209. If the priority output setting function is in the off state, that is, if there is no priority output setting between the two photometers (C), the process proceeds to S208.

(S207) the priority output determination unit 59 outputs all the data including the second measurement result of the scattering photometer 45 from the output unit 71. Accordingly, all data including the second measurement result, such as absence of abnormality, is preferentially output to the user on the display screen of the output unit 71.

(S209) the preferential output determination unit 59 outputs all the data including the first measurement result of the absorption photometer 44 from the output unit 71. Accordingly, all data including the first measurement result, such as absence of abnormality, is preferentially output to the user on the display screen of the output unit 71.

(S208) the priority output determination unit 59 outputs all the data including both the first measurement result and the second measurement result from the output unit 71. In this way, all data including the results of the measurements of the two photometers, such as absence of abnormality, are output to the user on the display screen of the output unit 71. After S207, S208, or S209, the present flow ends.

[ (2) priority output alarm decision processing ]

Next, the content of the priority output alarm determination process of step S205 in fig. 9 will be described with reference to the drawings of fig. 10 and the following. Fig. 10 shows a flow 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. In this process, the data alarm associated with each measurement result of the two photometers is determined which classification the data alarm belongs to based on the above-described group and classification definition of the class. The present flow includes steps S301 to S305. The following description will be made in order of steps.

(S301) the alarm determination unit 60 preferentially outputs two kinds of data alarms, i.e., a first data alarm indicated in the first measurement result of the absorption photometer 44 and a second data alarm indicated in the second measurement result of the scattering photometer 45. The priority output alarm determination unit 60 determines whether or not the third group and the high-ranked data alarm are included in one or both of the two types of data alarms. If the content is contained (yes), the process proceeds to S302, and if the content is not contained (no), the process proceeds to S303.

(S302) the priority output alarm determination unit 60 executes the high-level data alarm processing described later (fig. 11), and then ends the present flow.

(S303) the priority output alarm determination unit 60 determines whether or not the second group and the medium-level data alarm are included in one or both of the two types of data alarms. If the content is contained (yes), the process proceeds to S304, and if the content is not contained (no), the process proceeds to S305.

(S304) the priority output alarm determination unit 60 executes the intermediate-level data alarm processing described later (fig. 12 and 13), and then ends the present flow.

(S305) in S303, the case of not including (no) corresponds to the case of not including the third group and the data alarm of the lower rank. In S305, the priority output alarm determination unit 60 executes low-level alarm processing (fig. 14) described later.

[ (3) high-level data alarm processing ]

Fig. 11 shows a flow of the high-level data alarm processing in S302. Fig. 11 has steps S401 to S405. The following description will be made in order of steps.

(S401) the priority output alarm determination unit 60 determines whether or not the first measurement result and the second measurement result have both high-level data alarms, that is, whether or not both the first data alarm and the second data alarm have both high-level data alarms. If both are at a high level (yes), the process proceeds to S402, and if not (no), the process proceeds to S403.

(S402) the alarm determination unit 60 is preferentially output as an output, and the output unit 71 outputs high-level data alarms of both the first data alarm and the second data alarm, and the flow is terminated.

(S403) the priority output alarm determination unit 60 determines whether or not one of the first data alarm and the second data alarm, for example, the first data alarm that absorbs light is a high-level data alarm. The priority output alarm determination unit 60 proceeds to S404 if the first data alarm is at a high level (yes), and proceeds to S405 if not (no).

(S404) the priority output alarm determination unit 60 causes the output unit 71 to output the first measurement result of the light absorption side and the first data alarm, and ends the flow.

(S405) the process proceeds to S405, and the second data alarm included in the second measurement result on the scattering side corresponds to a case where the second data alarm 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 ends the present flow.

In the above-described 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, only the data alarm may be output as the output control without outputting the concentration of the measurement result or the like. When the measurement result is obtained, the measurement result and a data alarm may be output.

As described above, the high-level data alarm is added when the user needs to perform an operation of improving the state of the mechanism, the specimen 2, the reagent 4, and the like, for an abnormality or the like. Therefore, when both measurement results include a high-level data alarm as described above, it is preferable to output all of these data alarms to call the user' S attention and prompt the user to perform the improvement task as shown in S402. In this case, the system alarm and the data alarm may be output simultaneously.

[ (4) Medium Scale alarm handling ]

Fig. 12 and 13 show the intermediate-level data alarm processing in S304. This processing is roughly performed when possible, and (a) both the first data alarm and the second data alarm are at the medium level, (b) only the first data alarm is at the medium level, and (c) only the second data alarm is at the medium level. Fig. 12 shows a part from step S501 to step S508. Fig. 13 shows step S509 to step S520 as a continuation of fig. 12.

(S501) the priority output alarm determination unit 60 determines the detailed category of the first data alarm included in the first measurement result of the absorption photometer 44 and the second data alarm included in the second measurement result of the scattering photometer 45 based on the classification definition described above. In S501, the priority output alarm determination unit 60 determines whether or not the first data alarm on the light-absorbing side is a data alarm generated due to a high concentration of the specimen 2. The data alarms of this type correspond to the aforementioned front belt alarm B1, the alarm B2 exceeding the upper limit of the quantitative range, and the like. If the data is a data alarm of this type (yes), the process proceeds to S502, and if not (no), the process proceeds to S504.

(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 S503, the priority output alarm determination unit 60 stores automatic re-examination request information, which is a condition that automatic re-examination using the absorption photometer 44 is required and the amount of the sample in the reaction container 25 of the target specimen 2 is reduced, in the data storage unit 55. The analysis control unit 50 performs automatic review under the condition in accordance with the automatic review request information, stores the result, and outputs the result to the output unit 71. After S503, the present flow ends.

In the cases of S501 to S503, the following determination and output control are performed. In the first measurement result using the absorption photometer 44 suitable for measuring a high concentration component, when it is determined that the concentration of the target component substance of the specimen 2 is excessively high, the reliability of the second measurement result using the scattering photometer 45 suitable for measuring a low concentration component is also low. Therefore, only the first measurement result of the light absorption side and the first data alarm are output as shown in S502, and the automatic review is performed under the condition of the decrement as shown in S503. Thus, it is attempted to bring the measurement result at the time of retest into an appropriate quantitative range (the aforementioned normal output range) of the absorptiometer 44.

(S504) the priority output alarm determination unit 60 determines whether or not the second data alarm on the scattering side is a data alarm generated due to the low concentration of the specimen 2. The data alarm of this type corresponds to the alarm B3 exceeding the lower limit of the quantitative range. If the data is a data alarm of this type (yes), the process proceeds to S505, and if not (no), the process proceeds to S507.

(S505 and S506) in S505, the priority output alarm determination unit 60 causes the output unit 71 to output the scattered second measurement result and the second data alarm. In S506, the priority output alarm determination unit 60 stores automatic re-examination request information, which is a condition that automatic re-examination using the scatterometer 45 is required and the amount of the detection object in the reaction container 25 of the target specimen 2 is increased, in the data storage unit 55. The analysis control unit 50 performs automatic review under the condition in accordance with the automatic review request information, stores the result, and causes the output unit 71 to output the result. After S506, the present flow ends.

In the cases of S504 to S506 described above, the following determination and output control are performed. In the second measurement result using the scattering photometer 45 suitable for the measurement of the low concentration component, when it is determined that the concentration of the target component substance of the specimen 2 is too low, the reliability of the first measurement result in the absorption photometer 44 suitable for the measurement of the high concentration component is low. Therefore, as shown in S505, only the second measurement result of the scattering side and the second data alarm are output, and as shown in S506, automatic review is performed under an incremental condition. Thus, it is attempted to bring the measurement result at the time of retest into an appropriate quantitative range of the scattering photometer 45 or the absorption photometer 44.

(S507) the priority output alarm determination unit 60 determines whether or not the second data alarm is a low-ranked data alarm with respect to the second data alarm of the one of the scattered second measurement results. The data alarm of this type corresponds to the serum information alarm C1 or the like described above. If the rank is the lower rank (yes), the process proceeds to S508, and if not (no), the process proceeds to S509 (fig. 13).

(S508) the priority output alarm determination unit 60 causes the output unit 71 to output the second measurement result and the second data alarm, which are one of scattered signals. In this case, the second measurement result is output as a reference value, and the flow is terminated without performing automatic review.

In the case of S508, the combination of the two data alarms corresponds to a state in which the data alarm generated due to the abnormality of the reaction process or the data alarm generated due to the low concentration of specimen 2 is added to the first measurement result and the data alarm of the lower level is added to the second measurement result. In this combination, at least one of the specimen 2 and the reagent 4 used for measurement has a cause of occurrence of a low-level data alarm. In this combination, the concentration of the target component substance in specimen 2 is lower than the lower limit of the quantitative range of absorption spectrophotometer 44. Therefore, the scattering photometer 45 can quantify the amount, but the absorbance photometer 44 has a low concentration and cannot quantify the amount. It is believed that as a result, such a combination is produced. That is, in the case of this combination, it can be determined that the measurement itself using the scattering photometer 45 is normally performed. Therefore, in this case, the second measurement result of the scattering side is outputted as a reference value, and automatic review is not performed.

(S509) in S509 in fig. 13, the priority output alarm determination unit 60 determines whether or not the second data alarm using the second measurement result of the scattering photometer 45 is an alarm generated due to the high concentration of the specimen 2. If the data is a data alarm of this type (yes), the process proceeds to S510, and if not (no), the process proceeds to S513.

(S510) the priority output alarm determination unit 60 causes the output unit 71 to output the first measurement result and the first data alarm using the absorption photometer 44.

(S511) the priority output alarm determination unit 60 determines whether or not the first data alarm is an alarm generated due to an abnormality in the reaction process. If the data is a data alarm of this type (yes), the process proceeds to S516, and if not (no), the process proceeds to S512.

(S516) the priority output alarm determination unit 60 stores, in the data storage unit 55, the automatic review request information that requires automatic review and is set to the same condition as the previous condition in which the abnormality or the like indicated by the first data alarm (i.e., the reaction process abnormality or the like) occurred. In S516, the combination of data alarms is such that the first measurement result is associated with a data alarm generated due to an abnormal reaction process, and the second measurement result is associated with a data alarm generated due to a high concentration of the specimen 2. In this case, the concentration of the target component substance in the specimen 2 exceeds the upper limit of the quantitative range of the scattering photometer 45, and it can be determined that the measurement by the absorption photometer 44 has failed. Therefore, in this case, re-measurement is performed under the same conditions as in the previous case. The automatic analyzer 1 checks the result of the automatic retest to see whether or not the concentration of the target component substance in the specimen 2 falls within the quantitative range of the absorption spectrophotometer 44. In this case, if it is considered that the automatic retest is performed under the condition of reducing the amount of the detection object, the quantitative range of the scattering photometer 45 may be lower. Therefore, the automatic review is performed under the same conditions as before. After S516, the flow ends.

(S512) when the process proceeds to S512, the priority output alarm determination unit 60 further determines whether or not the first data alarm for the light absorption side is an alarm generated due to a low concentration of the specimen 2. If the data is a data alarm of this type (yes), the process proceeds to S506, and if not (no), the automatic review is not necessary, and the flow is terminated.

When the flow proceeds from S512 to S506, the automatic retest is performed under the condition of increasing the amount of the detection substance, as described above. In this case, as a combination of data alarms, it is satisfied that the second measurement result is out of the upper limit value of the quantitative range of the scattering photometer 45 and the first measurement result is less than the lower limit value of the quantitative range of the absorption photometer 44. In this case, the possibility of measurement failure is high in both photometers. Therefore, as described above, re-measurement is performed under the same conditions, and an attempt is made to obtain a normal result.

If it is not (no), the automatic retest is not performed and the operation ends in S512, and in this case, it is appropriate that the data alarm generated due to the high concentration of specimen 2 is added to the second measurement result and the data alarm of the lower level is added to the first measurement result as a combination of the data alarms. This combination corresponds to a case where at least one of the specimen 2 and the reagent 4 used for measurement has a cause of a low-level data alarm. This combination corresponds to a case where the concentration of the target component substance in the specimen 2 is not quantitated by the scattering photometer 45 because it exceeds the upper limit of the quantitation range of the scattering photometer 45, but can be quantitated by the absorption photometer 44. Therefore, it is considered that the combination is generated. That is, in the case of this combination, it can be determined that the measurement has been normally performed in the first measurement result. Therefore, in this case, the first measurement result of the light absorption side is outputted as a reference value, and automatic review is not performed.

(S513) the priority output alarm determination unit 60 determines whether or not the first data alarm for the light absorption side is a data alarm generated due to an abnormal reaction process. If the data is a data alarm of this type (yes), the process proceeds to S514, and if not (no), the process proceeds to S518.

(S514) the priority output alarm determination unit 60 selects and outputs one of the measurement result and the data alarm to be output first from among the two measurement results and the data alarms, in accordance with the "priority output setting" set as a parameter in advance. At this time, the priority output alarm determination unit 60 performs determination by referring to the set value of the priority output setting information. If the set value is a value indicating "light absorption priority setting" (a), the process proceeds to S515, and if the set value is a value indicating "scattering priority setting" (B), the process proceeds to S517. As described above, in the "absorption priority setting", the absorption photometer 44 is set to output a photometer having a higher priority level than the scattering photometer 45. In the "scattering priority setting", the opposite priority output order is set.

(S515) the priority output alarm determination unit 60 selects the first measurement result and the first data alarm of the absorption photometer 44 based on the "absorption priority setting" and outputs the selected result and the first data alarm to the output unit 71. After S515, the process proceeds to S516.

(S517) the priority output alarm determination unit 60 selects the second measurement result and the second data alarm of the scattering photometer 45 based on the "scattering priority setting" and outputs the selected result and the selected second data alarm to the output unit 71. After S517, the process proceeds to S516.

(S516) after S515 or S517, in S516, the priority output alarm determination unit 60 makes an automatic review request under the same conditions as in the previous time, as the automatic review is required. That is, the priority output alarm determination unit 60 stores the automatic re-inspection request information such as the re-measurement condition that is the same as the condition when the abnormality or the like indicated by the data alarm occurs in the data storage unit 55.

The combination of the data alarms in the above-described cases of S513 to S517 corresponds to a state in which both the first measurement result and the second measurement result are added with a data alarm generated due to an abnormality in the reaction process. In this case, it can be determined that the measurement by both photometers has failed. Therefore, in this case, basically, the measurement result and the data alarm of either one of the photometers can be outputted. Therefore, in the above-described processing example, one of the measurement results and the data alarm is selected based on the determination of "priority output setting" in S514, and automatic review is performed under the same conditions as in the previous time in S516 to attempt to obtain a normal result.

(S518, S519) in S518, the priority output alarm determination unit 60 causes the output unit 71 to output the first measurement result of the light absorption side and the first data alarm. In S519, the priority output alarm determination unit 60 determines whether or not the first data alarm is an alarm generated due to a low concentration of the specimen 2. If the data is a data alarm of this type (yes), the process proceeds to S520, and if not (no), the automatic review is not performed, and the flow is terminated.

(S520) the priority output alarm determination unit 60 stores the automatic review request information on the condition that the amount of the detection object is increased in the data storage unit 55, and performs the automatic review.

In the combination of the data alarms in the above-described cases S518 to S520, it is appropriate that the data alarm generated due to the abnormality of the reaction process is added to the second measurement result, and the data alarm generated due to the low concentration of the specimen 2 is added to the first measurement result. In this case, it can be judged that the measurement by the scattering photometer 45 failed. Therefore, in S519, the first measurement result of the light absorption side and the first data alarm are output, and in S520, automatic review is performed. Thus, it is attempted to bring the measurement result in the automatic retest into the quantitative range of the absorptiometer 44.

In the case where no (no) is detected in S519, when the automatic review is not performed and the operation is terminated, it is appropriate that the data alarm generated due to the abnormality of the reaction process is added to the second measurement result and the data alarm of the lower rank is added to the first measurement result as a combination of the data alarms. In this case, it can be concluded that the measurement by the scattering photometer 45 failed, and the measurement itself by the absorption photometer 44 is normally completed. Therefore, in this case, in S519, the first measurement result is output as a reference value, and the first data alarm is output without automatic review.

[ (5) Low-level alarm processing ]

Fig. 14 shows the low-level data alarm processing of S305 described above. Fig. 14 includes steps S601 to S607. The following description will be made in order of steps.

(S601) the priority output alarm determination unit 60 checks whether or not both of the first data alarm indicated in the first measurement result of the absorption photometer 44 and the second data alarm indicated in the second measurement result of the scattering photometer 45 are low-level data alarms. If both are at the low level (yes), the process proceeds to S602, and if not (no), the process proceeds to S605.

(S602) the priority output alarm determination unit 60 performs priority output determination based on the "priority output setting", and selects and outputs the measurement result and the data alarm, which are to be output with priority. The priority output alarm determination unit 60 proceeds to S603 when the output is "scattering priority output" (B), and proceeds to S604 when the output is "light absorption priority output" (a).

(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 the selected result and second data alarm to the output unit 71. Thereafter, the automatic review is not performed, and the flow is ended.

(S604) the priority output alarm determination unit 60 selects the first measurement result and the first data alarm based on the "light absorption priority output" and outputs the selected result and the first data alarm to the output unit 71. Thereafter, the automatic review is not performed, and the flow is ended.

(S605) the priority output alarm determination unit 60 determines whether or not the first data alarm of only one light absorption type is low. If only the first data alarm is of a low rank (yes), the process proceeds to S606, and if not (no), that is, if only the scattering second data alarm is of a low rank, the process proceeds to S607.

(S606) the priority output alarm determination unit 60 selects the first measurement result and the first data alarm of the light-absorbing side, and outputs the result to the output unit 71. Thereafter, the automatic review is not performed, and the flow is ended.

(S607) the priority output alarm determination unit 60 selects one of the scattered second measurement results and the second data alarm, and outputs the selected second measurement result and second data alarm to the output unit 71. Thereafter, the automatic review is not performed, and the flow is ended.

As described above, in the case where each combination of low-level data alarms is included, since it can be determined that the measurement itself is normally completed, the measurement result is output as a reference value and automatic review is not performed.

[ Effect and the like ]

As described above, the automatic analyzer 1 according to embodiment 1 includes two types of photometers, i.e., the absorption photometer 44 and the scattering photometer 45, and performs simultaneous analysis using the two types of photometers for the target component substances of each test item. The automatic analyzer 1 refers to two kinds of data alarms that may be attached to two kinds of measurement results. When both of the two types of measurement results have two types of data alarms caused by an abnormality or the like at the time of measurement, the automatic analyzer 1 selects an appropriate measurement result, data alarm, or the like to be output, based on a combination of these data alarms. In this way, the automatic analyzer 1 performs output control so as to limit or reduce the amount of information to be output to the user as an analysis result even when there is an abnormality or the like in the measurement using the two photometers. Thus, according to the automatic analyzer 1, it is possible to obtain accurate analysis results in the simultaneous analysis as compared with the conventional art example, and it is possible to reduce the burden on the user in judgment, operation, and the like of the analysis result output even when there is an abnormality or the like at the time of measurement. When the user sees the output of the analysis result on the display screen, the user can easily recognize and determine the state and easily perform the handling work because the user has automatically selected and limited appropriate measurement results and information such as data alarms. Therefore, a judgment error of the user can be prevented, and a result report delay can be prevented.

In addition, even when there is an abnormality or the like in the measurement using the two photometers, the automatic analyzer 1 automatically performs appropriate control for automatic review based on a combination of data alarms. Even when there is an abnormality or the like in both types of measurement, the automatic analyzer 1 determines whether or not automatic retest and conditions are necessary so as to reflect at least one of the state of the analyzer and the state of the sample component. The automatic analyzer 1 determines whether or not appropriate automatic review and conditions are required based on the combination, controls the automatic review, and controls the result. This makes it possible to obtain more accurate results (concentration, etc.) in a shorter time by automatic review by effectively utilizing the automatic review function of the automatic analyzer 1, and to prevent a delay in reporting of results by the user.

[ modification (1) ]

The following is an example of a modification of the automatic analyzer 1 according to embodiment 1. In embodiment 1, the case where two types of photometers are provided has been described, but the present invention is not limited to this, and can be applied to the case where three or more types of photometers are provided. Further, the present invention can be applied to a case where a plurality of photometers of some kind are provided. For example, when three photometers are provided, simultaneous analysis can be performed using the three photometers. Alternatively, simultaneous analysis may be performed using two photometers selected according to setting and analysis requests among the three types. The output selection control may be performed in the same manner in accordance with a combination of a plurality of data alarms appended to the plurality of measurement results.

[ modification (2) ]

In embodiment 1, the data alarms corresponding to the abnormality and the like are roughly classified into three groups and levels, and different output control is performed according to the combinations. The classification of the data alarms described above may not be limited to three. As shown in the corresponding representation, the configuration may be such that the correlation of the output selection including the measurement result and the data alarm is defined for each combination of the data alarms concerning the measurement results of the plurality of types of photometers.

[ modification (3) ]

In embodiment 1, when a combination is generated in which the influence on the user is small and no particular problem is caused regardless of which information of the two kinds of measurement results and the data alarm is output, one information is selected and output based on the "priority output setting". However, the present invention is not limited to this, and a modification may be made such that the "priority output setting" is not used in the case of the above-described specific combination. In this modification, only a predetermined one of the information items or both of the information items are output in the case of the specific combination as described above based on the fixed setting in mounting.

[ modification (4) ]

In the above-described flowcharts, an example of the processing procedure in the output control process is shown, but the present invention is not limited thereto. For example, it is obvious that a configuration of a process flow in which the order of the type determination of each level, abnormality, and the like is changed is also possible. As a modification of the process flow configuration of embodiment 1, the following configuration is also possible. In step S507 of the middle-level data alarm processing in fig. 12, the following step S507-1 is provided before proceeding to step S508 by the determination result (yes). In step S507-1, it is determined whether or not a low-level data alarm is added to the first measurement result of the light-absorbing side. If an additional note is present (yes), the process proceeds to step S601 in fig. 14, and if no (no), the process proceeds to step S508. That is, in the case of this flow configuration, the middle-level data alarm processing and the low-level data alarm processing are realized as one flowchart. In this case, the processing flow of fig. 10 is configured to perform only the determination regarding the high level of S301. If the high level is included in S301 (yes), the high level data alarm processing in S302 is performed, and if the high level is not included (no), the processing flow in which the above-described intermediate level and low level processing are integrated is performed.

(embodiment mode 2)

An automatic analyzer according to embodiment 2 of the present invention will be described with reference to fig. 15. The basic configuration in embodiment 2 and the like is the same as embodiment 1, and the following describes the different configuration portions from embodiment 1 in embodiment 2 and the like.

[ treatment procedure ]

In embodiment 1, data alarms relating to a plurality of (two types of) photometers are classified into the aforementioned three groups and ranks. The medium-level data are further classified into (B-1) data alarm due to abnormal reaction process and (B-2) data alarm due to abnormal concentration of the specimen. The data alarms generated due to the abnormal concentration of the specimen are classified into data alarms generated due to a high concentration and data alarms generated due to a low concentration. Further, as shown in fig. 5 and the like, it is arranged to select an output according to a combination of data alarms.

In embodiment 2, it is not essential to classify data alarms (corresponding abnormalities, errors, and the like) relating to a plurality of (two types of) photometers into the above-described groups and levels, and it is sufficient to grasp a plurality of individual data alarms that may be generated. In the automatic analyzer according to embodiment 2, in the process flow, the data alarms added to the measurement results using the photometers are referred to, and the data alarms are directly selected and output based on the combination of the data alarms. In embodiment 2, similarly to the above-described example of the correspondence table, the association between the combination of data alarms and the output is predetermined. Based on this specification, the process flow in embodiment 2 is installed. The analysis control unit 50 refers to the two types of measurement results and data such as a data alarm, which are stored in the data storage unit 55 as the processing results of the analysis unit 52. The analysis control unit 50 determines a combination of the data alarms referred to in the processing flow, and selects the measurement result, the data alarms, and the automatic review information as correlatable outputs based on the combination.

The process flow configuration of embodiment 2 differs from the process flow configuration of embodiment 1 in the content of the priority output alarm determination process of step S205 in fig. 9 described above (fig. 10 and the like). Fig. 15 shows a part of a process flow configuration example in the automatic analyzer 1 according to embodiment 2. In the automatic analyzer 1, when performing output control processing for simultaneous analysis using two types of photometers, processing is performed according to the flow shown in fig. 15 instead of the flow shown in fig. 10 and the like. In the flow of fig. 15, for example, first, in step S151, the analysis control unit 50 determines whether or not the aforementioned detection shortage alarm a1 is included as the first data alarm in the first measurement result of the absorption photometer 44. If the supplementary note is present (yes), the process proceeds to S152, and if the supplementary note is not present (no), the process proceeds to another step (omitted). In S152, the analysis control unit 50 determines whether or not the detection shortage alarm a1 is included as the second data alarm in the second measurement result using the scattering photometer 45. If the additional note is present (yes), the process proceeds to S153, and if the additional note is not present (no), the process proceeds to S154. If there is a supplementary note in S152 (yes), it is the case that both of the two types of data alarms are the detection shortage alarm a 1. In S151 and S152, the combination is confirmed. If the combination is, for example, the first combination, the analysis control unit 50 outputs the first data alarm and the second data alarm, which are both data alarms, as outputs corresponding to the first combination in S153. The processing content at this time is the same as the processing content of S401 and S402 of the high-level data alarm processing of fig. 11 in embodiment 1.

In S154, for example, the analysis control unit 50 determines whether or not the aforementioned reagent shortage alarm a2 is attached as the second data alarm of the second measurement result. If the supplementary note is present (yes), the process proceeds to S155, and if the supplementary note is not present (no), the process proceeds to another step (omitted). That is, in S151 and S154, a combination in which the first data alarm is the detection-deficient alarm a1 and the second data alarm is the reagent-deficient alarm a2 is confirmed. When the analysis control unit 50 sets the combination as a second combination, for example, in S155, the first data alarm and the second data alarm are output as outputs corresponding to the second combination.

As described above in the process flow example, in the automatic analysis device 1 according to embodiment 2, a matching combination of all combinations of data alarms that may occur is determined for two types of data alarms, and an output is selected based on a predetermined criterion from the determined combinations, as in embodiment 1.

As described above, according to embodiment 2, the same effects as those of embodiment 1 can be obtained.

(embodiment mode 3)

An automatic analyzer according to embodiment 3 of the present invention will be described with reference to fig. 16 and 17. In the automatic analyzer 1 according to embodiment 3, the analysis control unit 50 determines that not only the data alarm corresponding to the abnormality or the like at the time of measurement is added to each measurement result of the two photometers, but also the automatic review information relating to the automatic review function is created and added. In particular, the analysis unit 52 adds a data alarm corresponding to an abnormality or the like to the measurement result of a certain photometer, and determines whether or not automatic retest, retest conditions, and the like are necessary. Then, the analysis unit 52 associates and adds automatic retest information including information on whether or not automatic retest and retest conditions are necessary, with information on the target specimen 2 or the reaction vessel 25, the measurement result, and the data alarm, and stores the information in the data storage unit 55 as analysis data.

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 result, the data alarm, and the automatic review information for each of the two photometers stored in the data storage unit 55. The simultaneous analysis determination unit 56 and the like select and output based on a reference defined by a predetermined correspondence table based on a combination of the data alarm and the automatic review information in the two types of data. The selected outputs (i.e., analysis result output information) include measurement results, data alarms, and automatic review information as in embodiment 1. As described above, the automatic analyzer 1 according to embodiment 3 differs from the automatic re-inspection device according to embodiment 1 in the processing related to the automatic re-inspection function. As described above, in embodiment 3, the analysis unit 52 temporarily determines the measurement result of each photometer for the automatic review function, and creates and adds the automatic review information. The automatic review information (review flag information described below) added to the analysis unit 52 is different from the meaning of the automatic review information described above. Thereafter, the analysis control unit 50 newly selects and determines an output including the automatic review information in an integrated manner based on a combination of the two kinds of measurement results including the automatic review information and the data alarm.

[ automatic review information (review mark) ]

In embodiment 3, the analysis unit 52 creates and adds predetermined forms of automatic review information (described as review flag information). The analysis unit 52 determines whether or not automatic re-inspection is necessary, re-measurement conditions when necessary, and the like, when a first data alarm corresponding to an abnormality or the like at the time of measurement is added to the first measurement result using the absorption photometer 44, for example. The analysis unit 52 adds the automatic review information (first review flag) corresponding to the determination result to the first measurement result and the first data alarm. Similarly, when a second data alarm corresponding to an abnormality or the like at the time of measurement is added to the second measurement result using the scattering photometer 45, the analysis unit 52 determines whether or not automatic re-inspection is necessary, re-measurement conditions when necessary, or the like. The analysis unit 52 adds the automatic review information (second review flag) corresponding to the determination result to the second measurement result and the second data alarm.

The reinspection flag is a value indicating whether or not automatic reinspection using a photometer of a corresponding type is necessary (presence or absence), and a condition for remeasurement. The analysis unit 52 associates data including the measurement result, the data alarm, and the reinspection flag with analysis request information of the reaction vessel 25 or the corresponding specimen 2 in which the target measurement value is obtained, and stores the data in the data storage unit 55.

In embodiment 3, the reinspection flags are classified into the following four categories according to the category of the data alarm. Identifiers of the review flags are F1 to F4.

(1) First recheck flag F1 is "no recheck flag": the first review flag F1 indicates that no (no) automatic review is required. Instead of the addition of the first review flag F1, the review flag itself may not be added.

(2) Second recheck flag F2 ═ same condition recheck flag ": the second re-inspection flag F2 indicates that automatic re-inspection is necessary (present), and as a condition, the same re-measurement condition or the like as that at the time of the previous measurement (that is, when abnormality or the like is detected) is set.

(3) Third recheck flag F3 is "decrement recheck flag": the third reinspection flag F3 indicates that automatic reinspection is required (presence of) and is set to a condition in which the amount of the detection object is reduced from the condition in the previous measurement.

(4) The fourth recheck flag F4 is "incremental recheck flag": the fourth reinspection flag F4 indicates that automatic reinspection is required (presence of) and is set as a condition for increasing the amount of the detection object from the condition at the time of the previous measurement.

As the process flow in embodiment 3, for example, the same applies to the parts of the level determination process of fig. 10 in embodiment 1 and the high-level data alarm process of fig. 11 described above.

[ treatment procedure ]

Fig. 16 and 17 show the flow of the middle-level data alarm processing performed by the analysis control unit 50 (particularly, the simultaneous analysis determination unit 56 and the like) in embodiment 3. Fig. 16 shows steps S701 to S708. Fig. 17, next to fig. 16, shows steps S709 to S720. This processing is performed when the data alarms included in the two types of measurement results include a medium-level data alarm as shown in the flow from fig. 10 to step S304. In the processing example of fig. 16, the output is selected based on the above-described determination of the review flag.

(S701) the analysis control unit 50 determines whether or not the "reduced amount reinspection flag" (third reinspection flag F3) is added as the reinspection flag to the first measurement result of the absorption photometer 44 and the first data alarm. If there is an addition (yes), the process proceeds to S702, and if there is no addition (no), the process proceeds to S704.

(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. In S703, the analysis control unit 50 stores, in the data storage unit 55, the automatic review request information that is determined to require automatic review and that is set as a condition for reducing the amount of the detector from the previous condition. The analysis control unit 50 controls the automatic review according to the automatic review request information, and outputs the result. After S703, the present flow ends.

The "reduced amount reinspection flag" (third reinspection flag F3) is added when the concentration of the target component substance in the sample 2 is too high. When the first measurement result using the absorption photometer 44 suitable for measuring a high concentration component is determined that the concentration of the target component substance of the specimen 2 is excessively high (for example, exceeds the upper limit value of the quantitative range), the reliability of the second measurement result using the scattering photometer 45 suitable for measuring a low concentration component is also low. Therefore, in this case, the first measurement result is output and the automatic review is performed under the condition of the above-described decrement. Thus, it is attempted to bring the measurement result at the time of retest into the quantitative range of the absorptiometer 44.

(S704) the analysis control unit 50 determines whether or not the "incremental review flag" is added to the second measurement result of the scatterometer 45 and the second data alarm (fourth review flag F4). If there is an addition (yes), the process proceeds to S705, and if there is no addition (no), the process proceeds to S707.

(S705 and S706) in S705, the analysis control unit 50 causes the output unit 71 to output the second measurement result and the second data alarm. In S706, the analysis control unit 50 stores the automatic review request information, which is set as a condition for increasing the amount of the detection object from the previous condition, in the data storage unit 55. The analysis control unit 50 controls the automatic review according to the automatic review request information. After S705, the present flow ends.

The "increased reinspection flag" (fourth reinspection flag F4) is added when the concentration of the target component substance in the sample 2 is too low. When the second measurement result using the scattering photometer 45 suitable for measuring a low concentration component is determined that the concentration of the target component substance of the specimen 2 is too low (for example, lower than the lower limit value of the quantitative range), the reliability of the first measurement result using the absorption photometer 44 suitable for measuring a high concentration component is low. Therefore, in this case, the second measurement result is output and the automatic review is performed under the above-described increment condition. Thus, it is attempted to bring the measurement result at the time of retest into the quantitative range of the scattering photometer 45 or the absorption photometer 44.

(S707) the analysis control unit 50 determines whether or not the "no review flag" is added to the second measurement result and the second data alarm (the first review flag F1). Alternatively, the step S707 may check whether or not the review flag itself is added. If there is an addition (yes), the process proceeds to S708, and if there is no addition (no), the process proceeds to S709.

(S708) the analysis control unit 50 causes the output unit 71 to output the second measurement result and the second data alarm without performing the automatic review, and ends the flow after S708.

(S709) in fig. 17, when the process proceeds to S709, the "reduced reinspection flag" (third reinspection flag F3) or the "same condition reinspection flag" (second reinspection flag F2) is assigned as the reinspection flag associated with the second measurement result. In S709, the analysis control unit 50 determines whether or not the "reduction review flag" is added to the second measurement result and the second data alarm (third review flag F3). If there is an addition (yes), the process proceeds to S710, and if there is no addition (no), the process proceeds to S713.

(S710) the analysis control unit 50 outputs the first measurement result of the absorption photometer 44 and the first data alarm via the output unit 71.

(S711) the analysis control unit 50 further determines whether or not the identical condition review flag (second review flag F2) is added to the first measurement result. If there is an addition (yes), the process proceeds to S716, and if there is no addition (no), the process proceeds to S712.

(S716) the analysis control unit 50 stores the automatic review request information, which has been set to the same condition as the condition in the previous measurement, in the data storage unit 55. The analysis control unit 50 controls the automatic review according to the automatic review request information. After S716, the present flow ends.

Further, when the process proceeds to S712, the analysis control unit 50 determines whether or not an incremental review flag (fourth review flag F4) is added to the first measurement result. If an addition is made (yes), the process proceeds to S706, and if no addition is made (no), the automatic review is not performed, and the flow is terminated.

(S713) the analysis control unit 50 determines whether or not the identical condition review flag (second review flag F2) is added to the first measurement result. If there is an addition (yes), the process proceeds to S714, and if there is no addition (no), the process proceeds to S718.

(S714) the analysis control unit 50 performs the priority output determination in accordance with the "priority output setting". If the output is "absorption priority output" (a), the process proceeds to S715, and if the output is "scattering priority output" (B), the process proceeds to S717.

(S715) the analysis control unit 50 causes the output unit 71 to output the first measurement result using the absorbance photometer 44 and the corresponding first data alarm in accordance with the "absorption priority output".

(S717) the analysis control unit causes the output unit 71 to output the second measurement result using the scattering photometer 45 and the corresponding second data alarm, based on the "scattering priority output".

(S716) after S715 or S717, in S716, the analysis control unit 50 stores the automatic review request information, which has been set to the same condition as the condition in the previous measurement, in the data storage unit 55.

(S718) the analysis control unit 50 causes the output unit 71 to output the first measurement result using the absorption photometer 44 and the first data alarm.

Further, (S719) the analysis control unit 50 determines whether or not an incremental review flag (fourth review flag F4) is added to the first measurement result. If an addition is made (yes), the process proceeds to S720, and if not (no), the automatic review is not performed, and the flow is terminated.

(S720) the analysis control unit 50 stores the automatic review request information, which is a condition for increasing the amount of the detection object from the previous condition, in the data storage unit 55. After S720, the present flow ends.

As shown in the above processing example, in embodiment 3, the output (measurement result, data alarm, and automatic review information) is selected comprehensively from the combination of the measurement result, data alarm, and review flag for each photometer. Thus, even when there is an abnormality or the like in both the measurements, automatic retesting can be appropriately controlled and the retesting can be performed quickly. Therefore, a more accurate result can be obtained, and a delay in reporting of the result by the user or the like can be prevented.

In addition, as the above-mentioned conditions for automatic re-detection, i.e., re-measurement conditions, for example, the following modes can be used when determining the conditions for decreasing the amount of the detection object and the conditions for increasing the amount of the detection object. In this embodiment, a predetermined value such as a predetermined amount or ratio is used, and the value of the previous condition is reflected by adding or multiplying the value of the predetermined value or ratio, thereby determining the amount of the detection object or the like under the re-measurement condition. Alternatively, as another mode, a plurality of conditions for the amount of the analyte to be a candidate may be defined and set in advance, and the amount of the analyte to be re-measured may be determined by selecting and switching from these conditions.

The present invention has been described specifically based on the embodiments, but the present invention is not limited to the above-described embodiments, and various modifications can be made without departing from the scope of the invention.

Description of the symbols

1 … automatic analyzer, 2 … specimen, 3 … reaction liquid, 4 … reagent, 25 … reaction container, 44 … absorption spectrophotometer, 45 … scattering photometer, 50 … analysis control part.