JP7246498B2 - COMBINED AUTOMATIC ANALYZER, SYSTEM, AND ABNORMALITY DETERMINATION METHOD - Google Patents

Description

The present invention relates to a combined automatic analysis device, a combined automatic analysis system, and an abnormality determination method thereof.

Some automatic analyzers use a reaction process curve to determine abnormality. There is Patent Document 1 as a background art of this technical field. This patent document discloses a means for identifying an abnormal site in a blood coagulation test apparatus when there is an abnormality in the reaction process curve a plurality of times in succession.

In addition, when an operator is unfamiliar with the apparatus and error information including trouble occurs in the apparatus, it takes time to identify the cause of the error. In order to solve this problem, Patent Document 2 provides an automatic analyzer that can easily eliminate various errors at once.

Furthermore, in recent years, there has been an increasing need for an automatic analyzer capable of handling a plurality of inspection items with a single device. For example, as described in Patent Document 3, there is an automatic analyzer that integrates a biochemical analysis section and a blood coagulation analysis section.

International Publication No. WO16/002394 JP 2008-051532 A International Publication No. WO13/187210

As described in Patent Literature 3, automatic analyzers include a composite automatic analyzer capable of measuring multiple inspection fields. In such a composite automatic analyzer, there are mechanisms shared by analyzes in different inspection fields. Analysis of different inspection fields requires different calculation methods for measurement data, making analysis of individual data complicated. In addition, if an abnormality occurs in a shared mechanism, it will affect multiple types of analysis.

Here, Patent Document 1 specializes in "abnormalities related to the coagulation unit" and Patent Document 2 specializes in "abnormalities related to biochemical items", and consideration is given to abnormality determination when an abnormality occurs in the combined automatic analyzer. There was a problem that it was not

Therefore, in the present invention, when an abnormality occurs, the cause of the abnormality can be quickly identified by relating it to a plurality of inspection fields, and the time required for resolving the abnormality can be shortened. An object of the present invention is to provide an apparatus, a system, and an abnormality determination method.

In order to achieve the above object, the present invention provides different types of analysis units, different detectors corresponding to the analysis units, a common mechanical unit used by the different types of analysis units, and an abnormality detection system for one analysis unit. Provided is a composite automatic analyzer configured to include a control section that executes determination or identification of an abnormality factor based on pre-stored measurement data of another analysis section.

Further, in order to achieve the above object, in the present invention, there is provided a compound automatic analyzer having different types of analysis units, different detectors corresponding to the analysis units, and a common mechanical unit used by the different types of analysis units. Provided is a composite automatic analysis system comprising an analysis device and a control unit that determines an abnormality of one analysis unit or identifies an abnormality factor based on prestored measurement data of another analysis unit. .

Furthermore, in order to achieve the above object, in the present invention, there is provided an anomaly determination method in which a combined automatic analyzer comprises different types of analysis units, different detectors corresponding to the analysis units, and different types of analysis. and a control unit for controlling the combined automatic analyzer. provides an abnormality determination method that is executed based on the measurement data of

Advantageous Effects of Invention According to the present invention, it is possible to quickly identify an abnormal location and shorten the time taken to resolve the abnormality in a composite automatic analyzer equipped with different detectors.

It is a figure which shows the basic composition of the automatic analyzer based on each Example. It is a figure which shows the other basic composition of the automatic analyzer based on each Example. It is a figure which shows the other basic composition of the automatic analyzer based on each Example. It is a figure which shows the basic composition of the control system and signal processing system of the automatic analyzer based on each Example. FIG. 5 is a diagram showing a flowchart for explaining abnormality determination processing according to the first embodiment; FIG. 10 is a diagram showing a quality control screen when the measurement result of blood coagulation analysis is determined to be abnormal according to Example 1; FIG. 10 is a diagram showing a reaction process curve when the absorbance in the biochemical analysis according to Example 1 shifts as a whole to an abnormally low value. FIG. 10 is a diagram showing a reaction process curve in which the measurement result of blood coagulation analysis according to Example 1 becomes abnormal; FIG. 10 is a diagram showing a reaction process curve when the absorbance drops sharply at the time of dispensing the second reagent in the biochemical analysis according to Example 1; FIG. 10 is a diagram showing a reaction process curve when absorbance suddenly drops during the reaction in the biochemical analysis according to Example 1; FIG. 10 is a diagram showing a flowchart for explaining abnormality determination processing according to the second embodiment; FIG. 10 is a diagram showing a reaction process curve with a shortened measurement result of blood coagulation analysis according to Example 2; FIG. 11 is a diagram showing a flowchart for explaining abnormality determination processing according to the third embodiment; FIG. 12 is a diagram showing a flowchart for explaining abnormality determination processing according to the fourth embodiment;

Hereinafter, various embodiments will be sequentially described as modes for carrying out the present invention with reference to the drawings. In addition, in several drawings, the same code|symbol was attached|subjected to the same thing.

<Overall configuration of the device>
FIG. 1A is a diagram showing the basic configuration of an automatic analyzer according to each embodiment. Here, as one aspect of the automatic analyzer, an example of a composite automatic analyzer that performs biochemical analysis, blood coagulation analysis such as blood coagulation fibrinolysis marker and blood coagulation time measurement, and immune analysis will be described.

Combined automatic analyzers generally include those having a biochemical analysis unit and a blood coagulation analysis unit, those having an immunoanalysis unit, a biochemical analysis unit, and a blood coagulation analysis unit, and those having an immunoanalysis unit and a biochemical analysis unit. including those with an immunoassay and a blood coagulation assay. That is, in the present specification, an automatic analyzer having different types of analysis units and different detectors corresponding to the analysis units is referred to as a compound automatic analyzer.

As shown in FIG. 1A, the automatic analyzer 1 of this configuration mainly includes a reaction disk 10, a sample disk 20, a first reagent disk 30-1, a second reagent disk 30-2, and a first photometer 40-1. , a second photometer 40-2, a blood coagulation time measuring unit 50, a computer 60, an interface 61, a control computer 63, and the like. In this specification, the computer 60, the interface 61, and the control computer 63 are collectively called a control section.

The reaction disk 10, which is a reaction vessel holder, is a disk-shaped unit that can intermittently rotate in the left-right direction. can be placed. The reaction cell 11 is maintained at a predetermined temperature such as 37° C. by a constant temperature bath 12 .

A large number of sample containers 21 containing biological samples such as blood and urine are placed on a sample disk 20, which is a sample container holding portion, in the configuration example shown in FIG. Can be placed along a direction.

A sample dispensing mechanism 22 is arranged near the sample disk 20 . The sample pipetting mechanism 22 aspirates a predetermined amount of sample from the specimen container 21 positioned at the pipetting (suction) position 20a on the sample disk 20, and transfers the sample to the pipetting (discharging) position 10a on the reaction disk 10. It is discharged into a certain reaction cell 11 .

A first reagent disk 30-1 and a second reagent disk 30-2, which are reagent container holders, are provided with a plurality of first reagent bottles 31-1 and second reagent bottles labeled with reagent identification information. 31-2 are arranged along the circumferential direction of the first reagent disk 30-1 and the second reagent disk 30-2, respectively. Reagent identification information includes barcodes, RFIDs, and the like. Here, a case where barcodes are used will be described as an example. These first reagent bottle 31-1 and second reagent bottle 31-2 contain reagent solutions corresponding to analysis items to be analyzed by the automatic analyzer 1. FIG. It is confirmed that the first reagent for biochemistry and scattering and the coagulation reagent are placed on the first reagent disk 30-1, and the second reagent for biochemistry and scattering is placed on the second reagent disk 30-2.

The first reagent barcode reader 32-1 and the second reagent barcode reader 32-2 read reagent bars attached to the outer walls of the first reagent bottle 31-1 and the second reagent bottle 31-2 at the time of reagent registration. read the code. The read reagent information is registered in the memory 64 together with position information on the first reagent disk 30-1 and the second reagent disk 30-2.

A first reagent dispensing mechanism 33-1 and a second reagent dispensing mechanism 33-2 are arranged near the first reagent disk 30-1 and the second reagent disk 30-2, respectively. At the time of reagent dispensing, inspection items located at respective dispensing (sucking) positions 30-1a and 30-2a on the first reagent disk 30-1 and the second reagent disk 30-2 are handled by the pipette nozzles provided therein. Reagents are sucked from the first reagent bottle 31-1 and the second reagent bottle 31-2 according to the conditions and discharged into the corresponding reaction cells 11 located at the dispensing (discharging) positions 10b and 10c on the reaction disk 10, respectively. do. After the reagent is discharged, it is stirred by the stirring mechanism 34 .

Here, the first photometer 40-1 is arranged on the outer peripheral side of the reaction disk 10. FIG. Light emitted from a first light source 41-1 arranged near the center of the inner circumference of the reaction disk 10 passes through the reaction cell 11 and is measured by the photometer 40-1. In this way, the measurement unit composed of the first photometer 40-1 and the first light source 41-1 arranged to face each other with the reaction disk 10 interposed therebetween is referred to as the first measurement unit. and Similarly, a measurement section in which the second photometer 40-2 and the second light source 41-2 are arranged to face each other with the reaction disk 10 interposed therebetween is referred to as a second measurement section.

Each reaction cell 11 containing a reaction liquid, which is a mixture of a sample and a reagent, is measured every time it passes in front of the photometer 40-1 or 40-2 while the reaction disk 10 is rotating. An analog signal of scattered light measured for each sample is input to an A/D (analog/digital) converter 62 . The inside of the used reaction cell 11 is cleaned by a reaction cell cleaning mechanism 35 arranged near the reaction disk 10 to enable repeated use.

This device is equipped with a setting that avoids the occurrence of carryover of specimens and reagents due to interaction between items. Carryover can be reduced or avoided by setting a washing operation during measurement for a combination of samples and reagents that carry over. Note that the carryover avoidance cleaning is performed on the reaction cell 11, the pipette nozzle of the first reagent dispensing mechanism 33-1, the pipette nozzle of the second reagent dispensing mechanism 33-2, and It can be set with the pipette nozzle of the sample pipetting mechanism 22 .

FIG. 1B shows the configuration of a composite automatic analyzer (rack type) 100 including a turntable biochemical analyzer and a blood coagulation time measuring unit as another basic configuration of the automatic analyzer according to each embodiment. Give an example. The main structural difference between the automatic analyzer (rack type) 100 shown in FIG. 1B and the automatic analyzer 1 shown in FIG. is. Here, the sample rack 101 can hold one or more sample containers. FIG. 1B shows a sample rack 101 holding five sample containers as an example.

The automatic analyzer (rack type) 100 mainly includes a rack supply unit 102, a rack storage unit 103, a transport line 104 for transporting the sample rack 101 to the analysis unit 110, and a transport line 104 for transporting the sample rack 101 in the direction opposite to the transport line 104. A return line 105, a rack standby section 106, a transfer line 104, a standby section handling mechanism 107 for drawing the sample rack 101 from the return line 105 to the rack standby section 106, a rack return mechanism 108, and a sample rack 101 on the transfer line 104. It is composed of a reading unit (conveyance line) 109 for reading identification information such as a bar code, and an analysis unit 110 . Here, explanations that duplicate the content described above with reference to FIG. 1A will be omitted, and a sample supply method unique to the configuration of the automatic analyzer (rack type) 100 will be explained in detail. Although a line type consisting of a transport line 104 and a return line 105 will be described as a transport unit here, it can be applied to various aspects such as a bidirectionally movable hand mechanism.

In the automatic analyzer (rack type) 100, the transport system of the analysis unit 110 arranged along the transport line 104 includes a reading unit (analysis unit) 111 for collating analysis request information for the sample, and A rack handling mechanism (1) 112 that receives the sample rack 101, and a sample rack 101 up to a sampling area 113a that allows the sample rack 101 to stand by until the start of dispensing and performs sample dispensing in the sample container of the sample rack 101. A pipetting line 113 for transporting and a rack handling mechanism (2) 114 for transporting the sample rack 101 after pipetting the sample to the return line 105 are provided.

When an instruction to start analysis is received from the computer 60 , the sample racks 101 arranged in the rack supply section 102 are transferred to the transport line 104 . Here, the individual identification medium attached to the sample rack 101 on the transport line 104 and the sample container 21 housed in the sample rack is read by the reading unit (transport line) 109, and the sample rack number and the sample container number are read. is recognized.

A sample read by the reading unit (conveyance line) 109 is accommodated in the rack standby unit 106 and waits for analysis if the sample rack 101 is present in the dispensing line 113 . The sample rack 101 waiting at the stage when the sample dispensing of the dispensing line 113 is completed is sent to the analysis unit 110, and the sample rack number and the sample container number are recognized by the reading unit (analysis unit) 111. Subsequently, it is sent to the dispensing line 113 via the rack handling mechanism (1) 112, and the specimen is dispensed by the specimen dispensing mechanism 22. FIG. At this time, if there is no sample rack 101 in the pipetting line 113 , the sample can be transported directly to the pipetting line 113 without being accommodated in the rack standby section 106 .

The sample that has been dispensed is conveyed to the return line 105 via the rack handling mechanism (2) 114 and sent to the rack standby section 106 via the standby section handling mechanism 107 . The rack standby section 106 can accommodate a plurality of sample racks 101, and by changing the order of measurement and transferring the required sample rack 101 to the transport line 104 each time, it is possible to respond flexibly.

FIG. 1C is a diagram showing the basic configuration of a composite automatic analyzer including a biochemical analysis unit, a blood coagulation time measurement unit, and a heterogeneous immunoassay unit as another basic configuration of the automatic analyzer according to each embodiment. be. In FIG. 1C, the configuration of the control unit subsequent to the control computer 63 shown in FIGS. 1A and 1B is omitted, but similar control units are provided.

In the combined automatic analyzer of FIG. 1C, a heterogeneous immunodetection unit 67 for heterogeneous immunity item measurement and a B/F separation mechanism 68 are arranged within the operation range of the reaction container transfer mechanism 55, and the disposable reaction container 52, The reaction container temperature control block 50, the reaction container transfer mechanism 55, the reaction container supply unit 53, and the reaction container disposal unit 57 are configured to be shared with the blood coagulation time measurement unit. In addition, a heterogeneous immunization reagent disk 69 is added within the operation range of the second reagent dispensing mechanism 56 with a reagent heating function.

Next, a control system and a signal processing system common to the combined automatic analyzers shown in FIGS. 1A, 1B, and 1C will be described. In addition, the configuration in which the control unit after the control computer 63 shown in FIGS. analysis units, different detectors corresponding to the analysis units, and a common mechanical unit used by different types of analysis units; based on pre-stored measurement data from other analysis units.

As described above, the computer 60 is connected via the interface 61 to the A/D converter 62 and the control computer 63 . A computer 60 having an operation screen 65 instructs the control computer 63 to control the operation of each mechanism such as the sample pipetting mechanism 22, the first reagent pipetting mechanism 33-1, the second reagent pipetting mechanism 33-2, and the like. instruct. The photometric values converted into digital signals by the A/D converter 62 are taken into the computer 60 .

A memory 64, which is a storage device, is connected to the interface 61, and information such as reagent identification information, specimen identification information, analysis parameters, analysis item request content, calibration results, measurement results, etc. is stored. In FIGS. 1A and 1B, the control unit such as the control computer 63 is connected to each component and controls the entire composite automatic analyzer. can also be configured to include

Next, in the photometer 40-1 of the automatic analyzer 1 of FIG. 1A, analysis of the first measurement item related to blood coagulation fibrinolytic markers such as D-dimer and FDP among biochemical tests and blood coagulation tests of samples. Operation will be explained. Analysis parameters related to items that can be analyzed by the automatic analyzer 1 are input in advance by the operator via the operation screen 65 and stored in the memory 64 . In order to analyze the test items requested and instructed for each sample, the sample dispensing mechanism 22 dispenses a predetermined amount of sample from the specimen container 21 to the reaction cell 11 at the dispensing position 10a according to the analysis parameters. do.

The reaction cell 11 into which the sample has been dispensed is transported by the rotation of the reaction disk 10 and stops at the dispensing (reagent receiving) position 10b or 10c. The first reagent dispensing mechanism 33-1 and the second reagent dispensing mechanism 33-2 dispense a predetermined amount of reagent liquid into the reaction cell 11 according to the analysis parameters of the corresponding inspection item. Here, as for the dispensing order of the sample and the reagent, the reagent may precede the sample.

When the reaction cell 11 crosses the photometry position, the light is measured by the photometer 40-1 and converted by the A/D converter 62 into a numerical value that is a signal value proportional to the light amount. After that, the converted data is taken into computer 60 via interface 61 . According to the configuration using such a turntable-type reaction disk 10, samples can be continuously dispensed by rotating the disk, so high throughput can be obtained.

Next, the computer 60 calculates the concentration data based on the numerical data converted into the signal values as described above and the calibration curve data previously measured and stored by the analysis method specified for each test item. It is calculated and output to the operation screen 65 . It should be noted that the calculation of the density data described above can also be performed by the control computer 63 instead of the computer 60 .

Next, an analysis operation relating to measurement of hemostatic function test items, that is, measurement of blood coagulation time, in the automatic analyzer 1 of FIG. 1A will be described. The disposable reaction container 52 housed in the reaction container housing part 53 is transferred to the sample dispensing station 54 by the reaction container transfer mechanism 55 . The sample dispensing mechanism 22 aspirates the sample from the specimen container 21 and dispenses it into the reaction container 52 transferred to the sample dispensing station 54 as described above.

Next, the reaction container 52 into which the sample has been dispensed is transported to the blood coagulation time measurement unit 50 by the reaction container transfer mechanism 55, and heated to 37°C. On the other hand, the reagent kept cold on the first reagent disk 30-1 is aspirated from the first reagent bottle 32-1 according to the inspection item by the first reagent pipetting mechanism 33-1, and is placed on the reaction disk 10. , and is heated to about 37°C.

After a certain period of time has passed, the reagent stored in the reaction cell 11 heated as described above is sucked by the reagent dispensing mechanism 56 with a reagent temperature raising function, and then further heated in this mechanism. 40°C. Here, the reaction container 52 containing the sample heated to 37° C. as described above is transferred by the reaction container transfer mechanism 55 to the measurement channel 51 in the blood coagulation time measurement unit 50 which will be described later. After that, the reagent dispensing mechanism 56 with a reagent heating function discharges the heated reagent into the reaction container 52 . This discharge of the reagent initiates a blood coagulation reaction between the sample and the reagent within the reaction container 52 .

The blood coagulation time measuring unit 50, which is the second measuring section, has a plurality of measurement channels 51 each composed of a light source and a light receiving section. The measurement data are collected at short measurement time intervals of , for example, every 0.1 seconds. The collected measurement data is converted into a numerical value proportional to the amount of light by the A/D converter 62 and then input to the computer 60 via the interface 61 .

The computer 60 uses the numerical data thus converted to determine the blood coagulation time. After that, based on the obtained blood coagulation time and the calibration curve data prepared and stored in advance according to the test item, the concentration data of the target test item is obtained and output to the operation screen 65 of the computer 60 . Also, the used reaction vessel 52 is transferred by the reaction vessel transfer mechanism 55 and discarded in the reaction vessel disposal section 57 . Here, the blood coagulation time and concentration data described above can also be calculated by the control computer 63 .

Here, in the blood coagulation time measurement unit 50, as described above, measurement data must be collected at predetermined short measurement time intervals, for example, every 0.1 seconds. can only be analyzed.

FIG. 1A shows the blood coagulation time measurement unit 50 having six measurement channels 51 as an example. For items, the next measurement cannot be accepted and is in a standby state. As a matter of course, a configuration having more measurement channels 51 can be employed depending on the analysis conditions.

<Basic configuration of device control system and signal processing system>
FIG. 2 is a diagram showing FIGS. 1A, 1B, and 1C, that is, the basic configuration of the control system and signal processing system of the composite automatic analyzer according to each embodiment. As shown in the figure, an operation screen 65, which is an operation unit, includes an input unit 651 for requesting measurement, a display unit 652 for outputting alarms, etc., and a control computer 63 for mechanism control for controlling the operation of various mechanisms. It is composed of a unit 631, a measurement management unit 632 that controls the order of measurements, a calculation unit 633 that performs data processing, an analysis unit 634 that analyzes measurement data, and an identification unit 635 that determines abnormality. These are realized by executing a predetermined function program. The memory 64 stores information such as reagent identification information, specimen identification information, analysis parameters, analysis item request content, calibration results, measurement results, etc. Here, data for storing calibration results and measurement results is stored. Only storage unit 641 is shown.

When a measurement is requested by the input section 651 of the operation screen 65, each mechanism is operated by the mechanism control section 631 to start the measurement. The measurement management unit 632 manages the measurement requests, the measurement proceeds in order, and the obtained signals are calculated as measurement data in the calculation unit 633 . The calculated measurement data is stored in the data storage unit 641 . The stored measurement data is referred to and analyzed by the analysis unit 634 to identify an abnormality. The analysis unit is composed of an absorption analysis 634a for measuring biochemical analysis items, a scattering analysis 634b for measuring immunological analysis items, and a blood time analysis 634c for measuring blood coagulation analysis items. Based on the information obtained by the analysis, the identifying unit 635 determines the cause of the abnormality. After the abnormality is identified, the display unit 652 displays optimal countermeasure information leading to the resolution of the abnormality, such as alarms and extracted recommended maintenance.

The automatic analyzer of Example 1 will be described with reference to FIGS. 3 to 8. FIG. This embodiment is an embodiment of a combined automatic analyzer and system that refers to past measurement data of blood coagulation analysis when an abnormality such as a low absorbance data value occurs in biochemical analysis. In other words, a configuration that has different types of analysis units and different detectors corresponding to the analysis units, and executes determination of abnormalities in biochemical analysis and identification of abnormal factors based on prestored measurement results of blood coagulation analysis. is an embodiment of Further, in the abnormality determination method, the combined automatic analyzer includes different types of analysis units, different detectors corresponding to the analysis units, a common mechanical unit used by the different types of analysis units, and a combined automatic analysis device. and a control unit for controlling the apparatus, wherein the control unit determines an abnormality of one analysis unit or identifies an abnormality factor based on pre-stored measurement data of another analysis unit. is.

It goes without saying that in the configuration of the first embodiment described below, the constituent elements are not necessarily essential, unless otherwise specified or clearly considered essential in principle.

FIG. 3 is a flow chart of abnormality determination processing executed by the automatic analyzer of the first embodiment. FIG. 4 is a diagram showing an example of a quality control screen when the measurement result of blood coagulation analysis according to this embodiment is determined to be abnormal. FIG. 5 is an example of a reaction process curve when the absorbance of the biochemical analysis according to the present example is abnormally low and shifts as a whole. FIG. 6 is an example of a reaction process curve in which the measurement result of the blood coagulation analysis according to this embodiment becomes abnormal. FIG. 7 is an example of a reaction process curve when the absorbance drops sharply when the second reagent is dispensed in the biochemical analysis according to this example. FIG. 8 is an example of a reaction process curve when the absorbance suddenly drops during the reaction in the biochemical analysis according to this example. In addition, in the composite automatic analyzer shown in FIG. 1A, explanations of parts having the same functions as those of the configuration denoted by the same reference numerals shown in FIG. 1A already explained will be omitted.

Factors for the abnormally low absorbance value in the biochemical analysis of this example include contamination of washing water, decrease in the amount of sample dispensed, decrease in the amount of reagent dispensed, poor stirring, misplacement of reagents, dilution of reagents, etc. can be considered. The details of the analysis flow of the automatic analyzer of this embodiment will be described with reference to FIG.

As shown in the figure, the combined automatic analyzer shown in FIG. 1A acquires measurement data (step, hereinafter S301), and stores the measurement data in the computer 60 (S302). S301 and S302 are performed by the measurement management unit 632 in FIG. Here, the measurement data of the biochemical analysis refers to the absorbance measured by the photometer 40-1 and converted into a signal value proportional to the amount of light by the A/D converter 62, described in <Overall configuration of the device>. Refers to data arranged in time series (reaction process curve) or calculated concentration data. The control computer 63 uses the obtained data to determine whether there is an abnormality (S303). Here, an abnormality includes, for example, a measured value exceeding the upper limit of a reference range, a measured value given an alarm, and the like, but is not limited to this embodiment.

Here, the action subject of other steps in FIG. 3 will be collectively described. S307 to S309, S314, and S316 are executed by the identification unit 635, and S315 is executed by the measurement management unit 632. FIG.

At S304, the measurement data of the biochemical analysis is compared with the same item control measurement, and if it is determined that the reaction course curve is shifted as a whole, the past blood coagulation analysis stored in the computer 60 is determined. , and confirms the frequency of occurrence of abnormalities in the measurement data such as calibration and control of blood coagulation analysis items on the same measurement day (S305).

Here, the occurrence frequency of abnormalities will be described with reference to FIG. FIG. 4 is a graph showing fluctuations in measured values when Control A was continuously measured every day. In FIG. 4, as indicated by an ellipse 331, when an abnormal value occurs for three consecutive days, it is determined to be abnormal, and abnormal frequent occurrence is notified. In this case, the frequency of occurrence of anomalies means that anomalous values occur for three consecutive days, and the occurrence of many anomalies is reported. As for the frequency for notifying the occurrence of an abnormality, the number of days and the number of times may be set on the screen.

The generally shifted reaction process curve mentioned above includes the reaction process curve shown by the solid line in FIG. The vertical axis in FIG. 5 indicates the absorbance, and the dashed line in FIG. 5 is the reaction process curve of the same item control. However, the aforementioned reaction process curve is an example and is not limited to this. Compared with the reaction process curve of the same item control, the reaction process curve obtained from the measurement is shifted to the lower value side as a whole. In the coagulation time analysis, the presence or absence of abnormality can be determined not only by the reaction process curve, but also by comparing calibration measurement values and control measurement values.

If it is determined in S306 that there is an abnormality in the measurement data of the past blood coagulation analysis, an abnormality caused by the sample dispensing mechanism 22 such as a decrease in the amount of sample pipetted, or an abnormality caused by the reaction cell cleaning mechanism 35 such as dropping of cleaning water. It is determined that there is an abnormality (S307). Here, in blood coagulation analysis, when abnormal shortening or abnormal extension occurs, the reaction process curve is as shown by the solid line in FIG. The vertical axis in FIG. 6 indicates the intensity of scattered light, and the dashed line in FIG. 6 indicates the reaction process curve in the normal case.

After the abnormality is identified, the identification unit 635 of the control computer 63 provides optimum countermeasure information leading to elimination of the abnormality (S308). The optimal countermeasure information leading to the resolution of the abnormality is, for example, outputting an alarm to the display section 652 of the operation screen 65 indicating that there is an abnormality in the reaction cell cleaning mechanism 35 or the sample dispensing mechanism 22. A display recommending maintenance such as cleaning the cleaning mechanism 35 or the sample dispensing mechanism 22 may be displayed, but this is not the only option.

On the other hand, if it is determined in S306 that there is no abnormality in the measurement data of the blood coagulation analysis, an abnormality caused by the first reagent dispensing mechanism 33-1, such as a decrease in the reagent dispensing amount, or a stirring mechanism 34, such as a stirring failure, is detected. It is determined that the cause is abnormal (S309). Here, the reason why the first reagent dispensing mechanism 33-1 is determined to be the cause of the abnormality will be described. The first reagent pipetting mechanism 33-1 is also used in blood coagulation analysis, but after the reagent more than the final pipetting set value is discharged into the reaction cell 11, the reagent pipetting mechanism with temperature increasing function Aspirate at 56 . At this time, since a small amount of reagent remains in the reaction cell 11, even if the amount dispensed by the first reagent dispensing mechanism 33-1 is not accurate, it does not directly affect the suction by the reagent dispensing mechanism 56 with temperature increasing function. .

After the abnormality is identified, optimal countermeasure information leading to elimination of the abnormality is provided by being displayed on the display unit 652 (S308). The optimal countermeasure information leading to the resolution of the abnormality is, for example, outputting an alarm to the operation screen indicating that the abnormality is caused by the first reagent dispensing mechanism 33-1 or the stirring mechanism 34. Cleaning of the pipette nozzle of the mechanism 33-1 and cleaning of the stirring rod of the stirring mechanism 34 are recommended, but not limited to this.

At S304, it is determined that there is no overall shift in the reaction process curve, at S310, it is determined that the reaction process curve has departed in the middle, and at S311, the timing of the deviation of the reaction process curve is the second reagent dispensing. If it is determined that it is time, the past blood coagulation analysis measurement data is referred to (S312), as in S305. Here, the detachment of the reaction process curve when dispensing the second reagent is the reaction process curve shown by the solid line in FIG. Compared with the control result indicated by the dashed line, the absorbance decreases at the second reagent dispensing time 601, and the final absorbance also decreases. As a result, the measured value shows an abnormally low value.

Next, if it is determined in S313 that there is an abnormality in the measurement data of the past blood coagulation analysis, it is determined that the abnormality is caused by the reaction cell cleaning mechanism 35 (S314). Here, an abnormality caused by the reaction cell cleaning mechanism 35 is contamination of cleaning water. Note that the determination method is not particularly limited, and a known method may be used for determination. On the other hand, if it is determined in S313 that there is no abnormality, it is determined that the abnormality is caused by the second reagent dispensing mechanism or the second biochemical reagent (S316). Here, the abnormality caused by the second reagent dispensing mechanism includes a decrease in the amount of reagent dispensed, and the abnormality caused by the second biochemical reagent includes misplacement of the reagent and dilution of the reagent.

If it is determined in S311 that the timing of the withdrawal of the reaction process curve is not at the time of dispensing the second reagent, it is determined that there is an abnormality caused by the reaction cell cleaning mechanism 35 . Here, the detachment of the reaction process curve when the second reagent is dispensed is the reaction process curve shown by the solid line in FIG. Compared to the control result indicated by the dashed line, the absorbance decreases in the middle of the reaction 701, and the final absorbance also decreases. As a result, the measured value shows an abnormally low value.

After the abnormality is identified, optimal countermeasure information leading to elimination of the abnormality is provided (S308). The optimal countermeasure information leading to resolution includes, but is not limited to, outputting an alarm indicating the location of the abnormality on the display unit 652, displaying a recommendation of maintenance for resolving the abnormality, and the like.

If it is determined that there is an abnormality in the measured value in S303, but it is determined that there is no overall shift or withdrawal in the middle of the reaction process curve, the sample may indicate an abnormal value because it is a patient sample. Therefore, the sample is retested (S315).

This embodiment is effective when an abnormality occurs in biochemical analysis. Since the past measurement results are checked and the location of the abnormality is specified based on the tendency of occurrence of the abnormality, it is possible to shorten the time required for identifying the location of the abnormality and eliminating the abnormality.

A composite automatic analyzer of Example 2 will be described with reference to FIGS. In this embodiment, different types of analysis units, different detectors corresponding to the analysis units, a common mechanical unit used by different types of analysis units, determination of an abnormality in one analysis unit or identification of an abnormality factor, Another embodiment of the combined automatic analyzer, system, and abnormality determination method comprising a control unit that executes based on pre-stored measurement data of another analysis unit, and in blood coagulation analysis, if there is an abnormality in the data. This is an example of referring to calibration data of past biochemical analyses, if any.

FIG. 9 shows a flowchart of abnormality determination processing described in the second embodiment. FIG. 10 is an example of an abnormal reaction course curve in the blood coagulation analysis exemplified in this example. In the following description of the embodiments, it goes without saying that the constituent elements are not necessarily essential, unless otherwise specified or clearly considered essential in principle. In addition, in the composite automatic analyzer of FIG. 1A, the description of the parts having the same functions as those of the configuration denoted by the same reference numerals shown in FIG. 1A already described will be omitted.

Possible causes of abnormal data in the blood coagulation analysis of this embodiment include a decrease in the amount of reagent dispensed, insufficient cleaning of the reaction cell, contamination of cleaning water, dilution of the reagent, erroneous placement of the reagent, deterioration of the reagent, and the like. The details of the flow of this embodiment shown in FIG. 9 will be described.

Measurement data for blood coagulation analysis is acquired (S901), and the measurement data is stored in the computer 60 in the same manner as in Example 1 (S902). Here, the measurement data of the blood coagulation analysis is the scattered light that is photometrically measured by the measurement channel 51 of FIG. This refers to data in which intensities are arranged in time series (reaction process curve), or calculated concentration data. The control computer 63 uses the obtained data to determine whether there is an abnormality (S903). Here, an abnormality includes, for example, a measured value exceeding the upper limit of a reference range, a measured value with an alarm, and the like, but is not limited to them.

An example of a reaction course curve with anomalies in blood coagulation analysis is shown by the solid line in FIG. The dashed line indicates the reaction course curve in the normal case. It has mountain-shaped noise 1001 due to air bubbles. The presence or absence of the aforementioned mountain-shaped noise 1001 can be determined by approximating an abnormal reaction process curve with an approximation curve. It can be determined by

In S904, when it is determined that the reaction process curve has mountain-shaped noise 1001 in the measurement data of the blood coagulation analysis described above, the past measurement data of the biochemical analysis stored in the computer 60 is referred to, and abnormal is confirmed (S905). Here, the frequency of anomalies means that when anomalous values occur for three consecutive days as shown by an ellipse 331 in FIG. The number of times is an example and is not limited to this. As for the frequency for notifying the occurrence of an abnormality, the number of days and the number of times may be set on the screen.

If it is determined that there is an abnormality in S906, it is determined that the abnormality is due to the first reagent dispensing mechanism 33-1, such as a decrease in the amount of reagent dispensed, or due to the reaction cell cleaning mechanism 34, such as insufficient cleaning ( S907). On the other hand, if it is determined that there is no abnormality in the result of the biochemical analysis in S906, it is determined that there is an abnormality caused by the reagent dispensing mechanism 56 with a temperature increasing function, such as a decrease in the amount of reagent dispensed (S909).

When it is determined in S904 that there is no mountain-shaped noise 1001 in the reaction process curve, and in S910 it is determined that there is abnormal shortening in the measured value, the measurement data of the past biochemical analysis is referred to in the same manner as in S905. (S911).

Next, if it is determined in S912 that there is an abnormality in the measurement data of the past biochemical analysis, in S913, it is checked whether carryover avoidance cleaning is set in the biochemical analysis item described above. If it is determined that carryover avoidance cleaning is present, it is determined that there is an abnormality caused by the reaction cell mechanism 34, such as contamination of cleaning water (S914).

On the other hand, if it is determined in S913 that there is no wash to avoid carryover in the biochemical analysis items described above, it is determined that there is an abnormality caused by the first reagent dispensing mechanism 33-1, such as a decrease in the amount of reagent dispensed (S915). If it is determined in S912 that there is no abnormality in the measurement data of the past biochemical analysis, it is determined that the abnormality is caused by the coagulation reagent (S916). Here, the abnormality caused by the coagulation reagent includes, but is not limited to, dilution of the reagent, erroneous installation of the reagent, deterioration of the reagent, and the like.

After the abnormality is identified in S907, S909, S914, S915, and S916, optimal countermeasure information leading to elimination of the abnormality is provided (S908). The optimal countermeasure information leading to the resolution of the abnormality includes, for example, outputting an alarm, displaying recommended maintenance on the display section 652 of the operation screen, but is not limited thereto.

If it is determined that there is an abnormality in the measured value in S903, but there is no mountain-shaped noise 1001 in the reaction process curve (S904) and it is determined that the measured value is not abnormally shortened (S910), the specimen is a patient specimen. Therefore, the sample is retested (S917).

This embodiment is effective when an abnormality occurs in blood coagulation analysis. As in the first embodiment, it is possible to shorten the time required for specifying the location of the abnormality and eliminating the abnormality.

The automatic analyzer of Example 3 is an example in which, when abnormal data is acquired in immunoassay, measurement data of past biochemical analysis and blood coagulation analysis are referred to. Needless to say, the constituent elements of the present embodiment are not necessarily essential, unless otherwise specified or clearly considered essential in principle.

FIG. 11 shows a flowchart of the abnormality determination process described in this embodiment. 1A and the flowchart in Example 1 of FIG. The description of the portion having is omitted.

Causes of abnormalities in the immunoassay of this embodiment include contamination of washing water, reduction in the amount of sample dispensed, reduction in the amount of reagent dispensed, poor stirring, misplacement of reagents, dilution of reagents, deterioration of the light source, and the like. Conceivable. Details of the flow of this embodiment will be described.

After obtaining the measurement data of the immunoassay in S1101, the measurement data are stored in the computer 60 in the same manner as in Examples 1 and 2 (S1102). Here, the measurement data of the biochemical analysis is the scattered light measured by the photometer 40-2 and converted into a signal value proportional to the light amount by the A/D converter 62, described in <Overall configuration of the device>. This refers to data in which intensities are arranged in time series (reaction process curve), or calculated concentration data. The control computer 63 uses the obtained data to determine whether there is an abnormality (S1103).

If it is determined in S1103 that there is an abnormality, it is determined in S1104 whether there is an overall shift in the reaction process curve. On the other hand, if it is determined in S1103 that there is no abnormality, the flow ends.

If it is determined in S1104 that there is an overall shift in the reaction process curve, reference is made to past biochemical analysis measurement data (S1105). If it is determined that there is an abnormality in the measurement data of the biochemical analysis referred to above (S1106), the abnormality is classified. Here, since the classification of anomalies has already been described in S304 of the first embodiment, the explanation is omitted, and the subsequent flow follows the steps from S304 of the first embodiment.

If it is determined in S1104 that there is no overall shift in the reaction course curve, the specimen is retested (S1108). If it is determined that there is no abnormality in the biochemical analysis measurement data referred to in S1105, it is determined that there is an abnormality caused by the second light source 40-2, such as a decrease in the light source. After the abnormality is identified, optimal countermeasure information leading to elimination of the abnormality is provided in S1110.

This embodiment is effective when an abnormality occurs in immunoassay. As in the first and second embodiments, it is possible to shorten the time required for specifying the location of the abnormality and eliminating the abnormality. In addition, immunoassays are more sensitive than biochemical assays and may uncover causes of abnormalities that biochemical assays do not.

Example 4 is an example of referring to measurement data of past immunoassay and blood coagulation analysis when data abnormality occurs in biochemical analysis. In the following description of Embodiment 4, it goes without saying that the constituent elements are not necessarily essential, unless otherwise specified or clearly considered essential in principle.

FIG. 12 shows a flowchart of the abnormality determination process described in this embodiment. 1A and the flow in Example 1 in FIG. The description of the portion having the same is omitted.

Causes of abnormalities in biochemical analysis of the apparatus of this embodiment include a decrease in the amount of reagent dispensed, poor stirring, a decrease in the amount of sample dispensed, falling washing water, deterioration of the light source, and the like. The details of the flow chart of this embodiment will be described.

If it is determined in S1201 that there is an abnormality, the reaction process curve is checked in S1202. If the reaction course curve has shifted as a whole, reference is made to the past immunoassay measurement data stored in the computer 60 (S1203). If not shifted, the sample with data abnormality is retested (S1209).

If it is determined that there is an abnormality in S1204, it is determined that the abnormality is caused by one of the first reagent dispensing mechanism 33-1, stirring mechanism 34, sample dispensing mechanism 22, and reaction cell cleaning mechanism 35 (S1205). In order to further narrow down these abnormalities, the blood coagulation analysis measurement data is referred to in S1206. After that, the process proceeds in the same manner as the flow from S305 in the first embodiment, and in S1207, optimal countermeasure information leading to resolution of the abnormality is provided.

On the other hand, if it is determined in S1204 that there is no abnormality, it is determined that the abnormality is caused by the first light source 40-1, such as deterioration of the light source (S1208). After the abnormality is identified, in S1207, optimal countermeasure information leading to elimination of the abnormality is provided.

As described in detail above, in the combined automatic analyzer of the present invention, even when an abnormality occurs, the cause of the abnormality can be quickly identified in relation to a plurality of inspection fields, and the optimum countermeasures can be taken to resolve the abnormality. Providing information shortens the time required to resolve anomalies. For example, the cause of an abnormality in the reaction process curve is identified by referring to past data in a plurality of inspection fields. At this time, after identifying the location of the abnormality and the cause of the abnormality in consideration of the frequency of occurrence of the abnormality, it is possible to extract the optimum countermeasures for resolving the abnormality.

It should be noted that the present invention is not limited to the above-described embodiments, and includes various modifications. For example, the above-described embodiments have been described in detail in order to explain the present invention in an easy-to-understand manner, and are not necessarily limited to those having all the configurations and judgment conditions described. It is also possible to replace part of the configuration of one embodiment with the configuration of another embodiment, or to add the configuration of another embodiment to the configuration of one embodiment. . Moreover, it is possible to add, delete, or replace a part of the configuration of each embodiment with another configuration.

Furthermore, the above-mentioned configurations, functions, control computers, etc. have mainly been explained by creating a program that implements a part or all of them, but by designing a part or all of them with an integrated circuit, etc. Needless to say, it may be realized by hardware. That is, all or part of the functions of the control computer may be realized by integrated circuits such as ASIC (Application Specific Integrated Circuit) and FPGA (Field Programmable Gate Array) instead of programs.

Reference Signs List 1 Automatic analyzer 10 Reaction disk 10a Dispensing (discharging) position 10b Dispensing (discharging) position 10c Dispensing (discharging) position 11 Reaction cell 12 Constant temperature bath 20 Sample disk (specimen disk)
20a... Dispensing (aspirating) position 21... Specimen container 22... Sample dispensing mechanism 23... Sample bar code reader 30-1... First reagent disk 30-2... Second reagent disk 30-1a... Dispensing (aspirating) Position 30-2a... Dispensing (sucking) position 31-1... First reagent bottle 31-2... Second reagent bottle 32-1... First reagent barcode reader 32-2... Second reagent barcode reader 33 -1 First reagent dispensing mechanism 33-2 Second reagent dispensing mechanism 34 Stirring mechanism 35 Reaction cell cleaning mechanism 40-1 First photometer 40-2 Second photometer 41-1 First light source 41-2 Second light source 50 Blood coagulation time measurement unit 51 Measurement channel 52 Reaction container 53 Reaction container storage unit 54 Sample pipetting station 55 Reaction container transfer mechanism 56 Temperature raising Function-equipped reagent dispensing mechanism 57 Reaction container disposal unit 60 Computer 61 Interface 62 A/D converter 63 Control computer 64 Memory 65 Operation screen 66 Keyboard 67 Heterogeneous for measuring immune items Genius immunity detection unit 68 B/F separation mechanism 69 Heterogeneous immunity reagent disk 70 Test information system 100 Automatic analyzer (rack type)
Reference Signs List 101 Sample rack 102 Rack supply unit 103 Rack storage unit 104 Transport line 105 Return line 106 Rack standby unit 107 Standby unit Handling mechanism 108 Rack return mechanism 109 Reading unit (transport line)
110... Analysis unit 111... Reading unit (analysis unit)
112, 114... Rack handling mechanism 113... Dispensing line 113a... Sampling area

Claims (15)

a first analysis unit that performs a first analysis;
a second analysis unit that performs a second analysis of a type different from the first analysis;
a first detector corresponding to the first analysis unit;
a second detector corresponding to the second analysis unit;
a mechanism unit commonly used for the first analysis unit and the second analysis unit, and a control unit,
The control unit
Identification of an abnormality factor of one analysis unit out of the first analysis unit or the second analysis unit is specified in the other analysis unit out of the first analysis unit or the second analysis unit stored in advance. Execute based on the measurement data of the analysis unit,
A combined automatic analyzer, wherein the measurement data includes time-series data acquired by the first detector or the second detector. The combined automatic analyzer according to claim 1,
Further comprising a display unit that provides information on countermeasures required for the abnormal factor identified by the control unit,
A combined automatic analyzer characterized by: The combined automatic analyzer according to claim 1,
The first analysis unit is a biochemical analysis unit, the second analysis unit is a blood coagulation analysis unit, and the measurement data is time-series data measured by the blood coagulation analysis unit.
A combined automatic analyzer characterized by: The combined automatic analyzer according to claim 3,
said first detector or said second detector comprising a photometer;
The control unit creates a reaction process curve in which the light intensity obtained from the photometer is arranged in time series, and the biochemical analysis unit determines that there is an abnormality based on the reaction process curve.
A combined automatic analyzer characterized by: The combined automatic analyzer according to claim 4,
When the biochemical analysis unit determines that there is an abnormality, the control unit refers to the measurement data and identifies the cause of the abnormality by considering the frequency of occurrence of the abnormality.
A combined automatic analyzer characterized by: The combined automatic analyzer according to claim 1,
The first analysis unit is a blood coagulation analysis unit, the second analysis unit is a biochemical analysis unit, and the measurement data is calibration data of the biochemical analysis unit.
A combined automatic analyzer characterized by: The combined automatic analyzer according to claim 1,
The first analysis unit is an immunoanalysis unit, and the second analysis unit is a biochemical analysis unit or a blood coagulation analysis unit.
A combined automatic analyzer characterized by: The combined automatic analyzer according to claim 1,
The first analysis unit is a biochemical analysis unit, and the second analysis unit is an immunological analysis unit and a blood coagulation analysis unit,
A combined automatic analyzer characterized by: A first analysis unit that performs a first analysis, a second analysis unit that performs a second analysis of a type different from the first analysis, and a first analysis unit corresponding to the first analysis unit A composite automatic analyzer comprising a detector, a second detector corresponding to the second analysis unit, and a mechanical unit commonly used for the first analysis unit and the second analysis unit , a controller, and
The control unit
Identification of an abnormality factor of one analysis unit out of the first analysis unit or the second analysis unit is specified in the other analysis unit out of the first analysis unit or the second analysis unit stored in advance. Execute based on the measurement data of the analysis unit,
A composite automatic analysis system, wherein the measurement data includes time-series data acquired by the first detector or the second detector. The combined automatic analysis system according to claim 9,
A composite automatic analysis system, further comprising a display unit that provides information on countermeasures required for the cause of abnormality identified by the control unit. The combined automatic analysis system according to claim 9,
The first analysis unit is a biochemical analysis unit, the second analysis unit is a blood coagulation analysis unit, and the measurement data is time-series data measured by the blood coagulation analysis unit.
A composite automatic analysis system characterized by: The hybrid automatic analysis system according to claim 11,
The first detector or the second detector includes a photometer, and the controller arranges the light intensities obtained from the first detector or the second detector in a time series reaction process creating a curve, and determining that the biochemical analysis unit is abnormal based on the reaction process curve;
A composite automatic analysis system characterized by: An abnormality determination method comprising:
A combined automatic analyzer comprises a first analysis unit for performing a first analysis, a second analysis unit for performing a second analysis of a type different from the first analysis, and the first analysis. a first detector corresponding to the unit; a second detector corresponding to the second analysis unit; a mechanical unit commonly used for the first analysis unit and the second analysis unit; and
The control unit stores the identification of the abnormality factor of one of the first analysis unit and the second analysis unit in the first analysis unit or the second analysis unit, which is stored in advance. An abnormality determination method characterized in that it is executed based on measurement data of other analysis units. The abnormality determination method according to claim 13,
The first analysis unit is a biochemical analysis unit, the second analysis unit is a blood coagulation analysis unit, and the measurement data is time-series data measured by the blood coagulation analysis unit. Abnormality judgment method. The abnormality determination method according to claim 14,
said first detector or said second detector comprising a photometer;
The control unit creates a reaction process curve in which the light intensities obtained from the first detector or the second detector are arranged in time series, and the biochemical analysis unit detects an abnormality based on the reaction process curve. determine that
An abnormality determination method characterized by:

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