JP7407671B2 - Automatic analyzer and program - Google Patents

Description

The present invention relates to an automatic analyzer and program for analyzing components contained in a sample using a calibration curve.

Conventionally, a calibration curve is created in advance for each combination of reagents. For measurement results with different reagent information even though the values used for concentration calculation are the same, traceability of measurement results and reagent information can be maintained by creating a copy calibration curve with changed reagent information from the already created calibration curve. secure.

For example, Patent Document 1 describes a sample analyzer that includes a first storage area that stores a predetermined number of calibration curves that can be used for analysis, and a second storage area that stores calibration curves used in the past ( For example, see Patent Document 1). In the sample analyzer described in Patent Document 1, approved calibration curves are stored in a first storage area and a second storage area. The procedure for reusing a calibration curve used in the past is to display the search condition input screen, search for a calibration curve from the second storage area based on the input content, and if there is a calibration curve that matches, the first one. It is stored in a storage area.

JP2008-249576A

However, conventionally, there is a trade-off between the number of calibration curves that can be stored and the real-time nature of the operation. If the storage area is increased in order to store a large number of calibration curves, it will take time to search for the desired calibration curve, reducing operability. For example, more than 50 calibration curves may be created for one measurement item. On the other hand, if the storage area is made smaller, if a large number of copy calibration curves are created (in the case of a facility that processes a large number of cases), the original calibration curve created in advance will disappear from the storage area, making it necessary to measure the standard sample again. Become.

In the function of tracing measurement results using a copy calibration curve, it is necessary to store a plurality of copy calibration curves for one lot combination. When separating the calibration curves into "calibration curves that can be used for analysis" and "calibration curves used in the past" as in Patent Document 1, copy calibration curves are stored in both storage areas, so the storage capacity is large. It is necessary to prepare an area. In addition, in order to store the calibration curve in the second storage area in the first storage area, the operator must display the input screen, manually specify the calibration curve in the second storage area, and copy it to the first storage area. There is.

Under the above circumstances, there has been a need for a method for storing a sufficient number of calibration curves for operation while ensuring traceability of measurement results.

In order to solve the above problems, an automatic analyzer according to one aspect of the present invention includes a first storage area that stores a copy calibration curve in which part of the reagent information of a previously created calibration curve is rewritten, and a A second storage area that stores the original calibration curve created by A calibration curve search section that compares the reagent lot information and reagent container information as reagent information of the calibration curve with the reagent lot information and reagent container information of the reagent used for sample measurement; If a calibration curve with mismatched information and only matching reagent lot information is found, rewrite the reagent container information of the reagent information of the calibration curve with the reagent container information of the reagent used for sample measurement, and then search for the calibration curve. a measurement data processing unit that uses the line to process sample measurement data ;
The calibration curve whose reagent container information has been rewritten by the measurement data processing unit is stored in the first storage area as a copy calibration curve,
The calibration curve search unit searches the first storage area before the second storage area, and searches the second storage area if a calibration curve that can be used for processing the sample measurement data is not found. .

According to at least one aspect of the present invention, it is possible to store a sufficient number of calibration curves for operation while ensuring traceability of measurement results.
Problems, configurations, and effects other than those described above will be made clear by the following description of the embodiments.

1 is a schematic diagram showing an example of the overall configuration of an automatic analyzer according to a first embodiment of the present invention. 1 is a block diagram showing an example of the internal configuration of a computer according to a first embodiment of the present invention. FIG. 5 is a flowchart illustrating an example of a procedure for standard sample measurement processing according to the first embodiment of the present invention. 3 is a flowchart illustrating an example of a procedure for patient sample measurement processing according to the first embodiment of the present invention. FIG. 3 is a diagram showing a specific example of standard sample measurement and patient sample measurement according to the first embodiment of the present invention. FIG. 2 is a block diagram showing an example of the internal configuration of an automatic analyzer according to a second embodiment of the present invention. FIG. 6 is a diagram showing a specific example of patient sample measurement according to the second embodiment of the present invention.

Hereinafter, examples of modes for carrying out the present invention will be described with reference to the accompanying drawings. In this specification and the accompanying drawings, components having substantially the same functions or configurations are given the same reference numerals and redundant explanations are omitted.

<First embodiment>
[Example of overall configuration of automatic analyzer]
First, the overall configuration of an automatic analyzer according to a first embodiment of the present invention will be described.
FIG. 1 is a schematic diagram showing an example of the overall configuration of an automatic analyzer according to a first embodiment.
An automatic analyzer 1 shown in FIG. 1 is an example in which the automatic analyzer according to the present invention is applied to a biochemical analyzer. A biochemical analyzer automatically measures the amount of a specific component contained in a biological sample such as blood or urine.

As shown in FIG. 1, the automatic analyzer 1 includes a measurement mechanism 1A and a computer 30. The measurement mechanism 1A is an example of a measurement section, and includes a sample turntable 2, a dilution turntable 3, a first reagent turntable 4, a second reagent turntable 5, and a reaction turntable 6. . The measurement mechanism 1A also includes a sample dilution pipette 7, a sampling pipette 8, a dilution stirring device 9, a dilution cleaning device 11, a first reagent pipette 12, a second reagent pipette 13, and a first reaction stirring device 14. , a second reaction stirring device 15 , a multi-wavelength photometer 16 , a constant temperature bath 17 , and a reaction vessel cleaning device 18 .

The sample turntable 2 (an example of a sample container arrangement section) is formed in the shape of a substantially cylindrical container with one axial end open. The sample turntable 2 accommodates a plurality of sample containers 21 and a plurality of diluent containers 22. Inside the sample turntable 2, a calibrator 2a (standard sample) and a control 2b (control sample) are installed. Further, the inner part (inner two rows) of the sample turntable 2 is kept cold mainly for the purpose of keeping the calibrator 2a and the control 2b cold. The specimen container 21 accommodates a specimen (sample) such as blood or urine. The diluent container 22 contains a special diluent other than the normal diluent, physiological saline. Incidentally, when driving the sample turntable 2, the inside and outside are driven at the same time.

The plurality of sample containers 21 are arranged side by side in the circumferential direction of the sample turntable 2 at predetermined intervals. Further, two rows of specimen containers 21 arranged in the circumferential direction of the sample turntable 2 are set at a predetermined interval in the radial direction of the sample turntable 2.

The plurality of diluent containers 22 are arranged radially inside the sample turntable 2 than the rows of the plurality of sample containers 21 . Similar to the plurality of sample containers 21, the plurality of diluent containers 22 are arranged side by side at predetermined intervals in the circumferential direction of the sample turntable 2. Two rows of diluent containers 22 arranged in the circumferential direction of the sample turntable 2 are set at a predetermined interval in the radial direction of the sample turntable 2.

Note that the arrangement of the plurality of sample containers 21 and the plurality of diluent containers 22 is not limited to two rows, but may be arranged in one row, or may be arranged in three or more rows in the radial direction of the sample turntable 2. .

The sample turntable 2 is rotatably supported along the circumferential direction by a drive mechanism (not shown). The sample turntable 2 is rotated circumferentially at a predetermined speed within a predetermined angular range by a drive mechanism (not shown). Further, a dilution turntable 3 is arranged around the sample turntable 2.

A sample barcode reader 10 is provided on the side of the sample turntable 2. The sample barcode reader 10 reads barcodes attached to the sides of the sample container 21, diluent container 22, calibrator 2a container, and control 2b container accommodated in the sample turntable 2. The control unit 31 manages the specimen and diluent contained in the sample turntable 2 based on information read by the sample barcode reader 10.

Like the sample turntable 2, the dilution turntable 3, the first reagent turntable 4, the second reagent turntable 5, and the reaction turntable 6 are formed in the shape of a substantially cylindrical container with one end opened in the axial direction. ing. The dilution turntable 3 and the reaction turntable 6 are rotated circumferentially within a predetermined angular range at a predetermined speed by a drive mechanism (not shown). Note that the reaction turntable 6 is set to rotate approximately one rotation in the circumferential direction through one or more rotation operations (for example, approximately ⅓ or more rotation in one rotation operation).

The dilution turntable 3 accommodates a plurality of dilution containers 23 arranged in a circumferential direction of the dilution turntable 3. The dilution container 23 stores a sample that has been aspirated from the sample container 21 placed on the sample turntable 2 and diluted (hereinafter referred to as "diluted sample").

The first reagent turntable 4 accommodates a plurality of first reagent containers 24 arranged in a circumferential direction of the first reagent turntable 4 . Further, the second reagent turntable 5 accommodates a plurality of second reagent containers 25 arranged in a circumferential direction of the second reagent turntable 5 . The first reagent container 24 stores a concentrated first reagent, and the second reagent container 25 stores a second reagent. The reagent turntables 4 and 5 may be tray-shaped devices configured to accommodate a plurality of reagent containers, and are not limited to turntables.

The first reagent turntable 4 is housed in the first reagent turntable housing 24S. The first reagent turntable storage section 24S is formed in the shape of a bottomed, substantially cylindrical container having an axis in substantially the same direction as the first reagent turntable. Further, the second reagent turntable 5 is housed in the second reagent turntable storage section 25S. The second reagent turntable storage section 25S is formed in the shape of a substantially cylindrical container with a bottom and an axis in substantially the same direction as the second reagent turntable. The first reagent turntable storage section 24S and the second reagent turntable storage section 25S are configured such that a reagent turntable can be removed and attached, respectively.

Furthermore, the first reagent turntable 4, the first reagent container 24, the second reagent turntable 5, and the second reagent container 25 are maintained at a predetermined temperature by a cold storage mechanism (not shown). Therefore, the first reagent contained in the first reagent container 24 and the second reagent contained in the second reagent container 25 are kept cool at a predetermined temperature.

The reaction turntable 6 is arranged between the dilution turntable 3, the first reagent turntable 4, and the second reagent turntable 5. The reaction turntable 6 accommodates a plurality of reaction vessels 26 arranged in a circumferential direction of the reaction turntable 6 . The reaction container 26 contains a diluted sample sampled from the dilution container 23 of the dilution turntable 3, a first reagent sampled from the first reagent container 24 of the first reagent turntable 4, and a second reagent sampled from the second reagent turntable 5. The second reagent sampled from the reagent container 25 is injected. Then, within this reaction container 26, the diluted sample, the first reagent, and the second reagent are stirred and a reaction is performed.

A sample dilution pipette 7 (an example of a sample injection section) is arranged around the sample turntable 2 and the dilution turntable 3. The sample dilution pipette 7 is supported so as to be movable in the axial direction (for example, in the vertical direction) of the sample turntable 2 and the dilution turntable 3 by a dilution pipette drive mechanism (not shown). Further, the sample dilution pipette 7 is rotatably supported by a dilution pipette drive mechanism along a horizontal direction that is substantially parallel to the openings of the sample turntable 2 and the dilution turntable 3. The sample dilution pipette 7 reciprocates between the sample turntable 2 and the dilution turntable 3 by rotating along the horizontal direction. Note that when the sample dilution pipette 7 moves between the sample turntable 2 and the dilution turntable 3, the sample dilution pipette 7 passes through a cleaning device (not shown).

Here, the operation of the sample dilution pipette 7 will be explained.
When the sample dilution pipette 7 moves to a predetermined position above the opening in the sample turntable 2, the sample dilution pipette 7 descends along the axial direction of the sample turntable 2, and the pipette provided at its tip is moved to the sample container 21. Insert inside. At this time, a sample pump (not shown) is activated, and the sample dilution pipette 7 sucks a predetermined amount of the sample contained in the sample container 21 . Next, the sample dilution pipette 7 moves upward along the axial direction of the sample turntable 2 and extracts the pipette from the sample container 21 . Then, the sample dilution pipette 7 rotates in the horizontal direction and moves to a predetermined position above the opening in the dilution turntable 3.

Next, the sample dilution pipette 7 is lowered along the axial direction of the dilution turntable 3 and inserted into a predetermined dilution container 23 . Then, the sample dilution pipette 7 discharges the aspirated specimen and a predetermined amount of diluent (eg, physiological saline) supplied from the sample dilution pipette 7 itself into the dilution container 23 . As a result, the sample is diluted in the dilution container 23 to a predetermined concentration. The sample dilution pipette 7 is then cleaned by a cleaning device.

A sampling pipette 8 (an example of a sample injection part) is arranged between the dilution turntable 3 and the reaction turntable 6. Like the sample dilution pipette 7, the sampling pipette 8 is supported so as to be movable and rotatable in the axial direction (vertical direction) and horizontal direction of the dilution turntable 3 by a sampling pipette drive mechanism (not shown). The sampling pipette 8 then reciprocates between the dilution turntable 3 and the reaction turntable 6.

This sampling pipette 8 is inserted into the dilution container 23 of the dilution turntable 3 to aspirate a predetermined amount of the diluted sample. Then, the sampling pipette 8 discharges the aspirated diluted sample into the reaction container 26 of the reaction turntable 6.

The first reagent pipette 12 (an example of a first reagent injection part) is arranged between the reaction turntable 6 and the first reagent turntable 4, and the second reagent pipette 13 is arranged between the reaction turntable 6 and the second reagent turntable. It is placed between tables 5. The first reagent pipette 12 is supported so as to be movable and rotatable in the axial direction (vertical direction) and horizontal direction of the reaction turntable 6 by a first reagent pipette drive mechanism (not shown). The first reagent pipette 12 then reciprocates between the first reagent turntable 4 and the reaction turntable 6.

The first reagent pipette 12 inserts the pipette into the first reagent container 24 of the first reagent turntable 4 and aspirates a predetermined amount of the first reagent. The first reagent pipette 12 then discharges the sucked first reagent into the reaction container 26 of the reaction turntable 6.

Further, the second reagent pipette 13 (an example of a second reagent injection part) is moved in the axial direction (vertical direction) of the reaction turntable 6 by a second reagent pipette drive mechanism (not shown), similarly to the first reagent pipette 12. It is supported so as to be movable and rotatable in the horizontal direction. The second reagent pipette 13 then reciprocates between the second reagent turntable 5 and the reaction turntable 6.

The second reagent pipette 13 inserts the pipette into the second reagent container 25 of the second reagent turntable 5 and aspirates a predetermined amount of the second reagent. Then, the second reagent pipette 13 discharges the aspirated second reagent into the reaction container 26 of the reaction turntable 6.

The dilution stirring device 9 and the dilution cleaning device 11 are arranged around the dilution turntable 3. The dilution stirring device 9 inserts a stirring bar (not shown) into the dilution container 23 and stirs the sample and the diluent.

The dilution cleaning device 11 is a device that cleans the dilution container 23 after the diluted sample has been aspirated by the sampling pipette 8. This dilution cleaning device 11 has a plurality of dilution container cleaning nozzles. The plurality of dilution container cleaning nozzles are connected to a waste liquid pump (not shown) and a detergent pump (not shown). The dilution cleaning device 11 inserts a dilution container cleaning nozzle into the dilution container 23, drives a waste liquid pump, and sucks in the diluted sample remaining in the dilution container 23 through the inserted dilution container cleaning nozzle. The dilution cleaning device 11 then discharges the sucked diluted sample into a waste liquid tank (not shown).

Thereafter, the dilution cleaning device 11 supplies detergent from the detergent pump to the dilution container cleaning nozzle, and discharges the detergent into the dilution container 23 from the dilution container cleaning nozzle. The inside of the dilution container 23 is cleaned with this detergent. Thereafter, the dilution cleaning device 11 sucks the detergent through the dilution container cleaning nozzle to dry the inside of the dilution container 23.

The first reaction stirring device 14 , the second reaction stirring device 15 , and the reaction container cleaning device 18 are arranged around the reaction turntable 6 . The first reaction stirring device 14 inserts a stirring bar (not shown) into the reaction container 26 and stirs the diluted sample and the first reagent. This allows the reaction between the diluted sample and the first reagent to occur uniformly and quickly. Note that the configuration of the first reaction stirring device 14 is the same as that of the dilution stirring device 9, so a description thereof will be omitted here.

The second reaction stirring device 15 inserts a stirring bar (not shown) into the reaction container 26 and stirs the diluted sample, the first reagent, and the second reagent. Thereby, the reaction between the diluted sample, the first reagent, and the second reagent is uniformly and quickly performed. Note that the configuration of the second reaction stirring device 15 is the same as that of the dilution stirring device 9, so a description thereof will be omitted here.

The reaction container cleaning device 18 is a device that cleans the inside of the reaction container 26 after inspection. This reaction vessel cleaning device 18 has a plurality of reaction vessel cleaning nozzles. The plurality of reaction vessel cleaning nozzles, like the dilution vessel cleaning nozzles, are connected to a waste liquid pump (not shown) and a detergent pump (not shown). Note that the cleaning process in the reaction vessel cleaning device 18 is the same as that in the dilution cleaning device 11 described above, so a description thereof will be omitted.

Moreover, the multi-wavelength photometer 16 is arranged so as to face the outer wall of the reaction turntable 6 around the reaction turntable 6. The multi-wavelength photometer 16 performs optical measurements on the diluted sample (including the standard sample) injected into the reaction container 26 and reacted with the first reagent and the second reagent to determine the various components in the sample. The measurement results are output as numerical data called "absorbance" and the reaction state of the diluted sample is detected. A computer 30 is connected to the multi-wavelength photometer 16.

Furthermore, a constant temperature bath 17 is arranged around the reaction turntable 6. This constant temperature bath 17 is configured to keep the temperature of the reaction container 26 provided on the reaction turntable 6 constant at all times.

[Computer configuration example]
Next, a configuration example of the computer 30 will be described with reference to FIG. 2.
FIG. 2 is a block diagram showing an example of the internal configuration of the computer 30.
The computer 30 includes a control section 31, an analysis section 32, an input device 33, a display device 34, a storage section 35, a temporary storage section 36, and a clock section 37, which are connected to a bus (not shown). .

The control unit 31 is configured by an arithmetic processing device such as a CPU (Central Processing Unit) or a microprocessor. The control unit 31 is connected to each block of the automatic analyzer 1 (measuring mechanism 1A) via an interface unit (not shown), and controls the operation of each block by instructing the operation timing and transferring data to each block. control, and comprehensively controls the operation of the automatic analyzer 1 as a whole. The functions according to the present invention are realized by the control unit 31 reading and executing the program stored in the storage unit 35.

The control section 31 includes a calibration curve search section 311 and a measurement data processing section 312 as functions according to the present invention.

When searching for a calibration curve to be used in processing sample measurement data, the calibration curve search unit 311 searches for reagents of the calibration curve stored in at least one of the calibration curve database 353 and the original calibration curve database 354 in the storage unit 35. Compare the information with the reagent information of the reagent used for the analyte measurement. More specifically, the calibration curve search unit 311 retrieves reagent lot information as reagent information of a calibration curve (original calibration curve, copy calibration curve) stored in either the calibration curve database 353 or the original calibration curve database 354. The reagent container information is compared with the reagent lot information and reagent container information of the reagent used for sample measurement. The comparison result is sent to the measurement data processing section 312. A lot refers to a unit of reagents made under equal conditions. Even for reagents from the same lot, if the reagent containers are different, it is required to be able to trace and verify the reagent containers used.

When the calibration curve search unit 311 searches for a calibration curve in which the reagent container information does not match and only the reagent lot information matches, the measurement data processing unit 312 uses the reagent container information among the reagent information of the calibration curve for sample measurement. Rewrite the reagent container information used and duplicate the calibration curve. That is, the measurement data processing unit 312 creates a copy calibration curve in which the reagent container information is rewritten to the reagent container information used for sample measurement from the calibration curve with which only the reagent lot information matches. The measurement data processing unit 312 then uses the copy calibration curve to process the sample measurement data.

The control unit 31 is connected to the analysis unit 32, and when the measurement result of the absorbance of the reaction container 26 measured by the multi-wavelength photometer 16 of the measurement mechanism 1A is input, the control unit 31 outputs the measurement result to the analysis unit 32.

The analysis section 32 applies the above-mentioned calibration curve to the measurement result by the multi-wavelength photometer 16 to analyze the component concentration of the sample, and outputs the analysis result to the control section 31 . Note that the control section 31 may have the analysis function of the analysis section 32.

The input device 33 accepts operation input to the automatic analyzer 1 performed by an operator, and outputs an input signal to the control section 31. For example, a mouse, a keyboard, a touch panel, etc. are used as the input device 33. The operator operates the input device 33 to input information necessary for analysis, such as the type of specimen to be measured, the number of specimens, analysis items (measurement items), and the time period (time range) in which the analysis is to be performed. Note that each specimen is assigned a specimen ID (identifier) that can uniquely identify the specimen.

The display device 34 displays an analysis result screen, a warning screen, an input screen for inputting various settings, and the like. For example, a liquid crystal display device or the like is used as the display device 34.

The storage unit 35 is configured by, for example, a ROM such as a flash memory that can store updates. Alternatively, the storage unit 35 may be realized by a large-capacity recording device such as an HDD (Hard Disk Drive) built-in or connected via a data communication terminal, an information storage medium such as a CD-ROM, and a reading device thereof. In addition to the analysis results, the storage unit 35 stores various programs necessary for the operation of the automatic analyzer 1, data related to the execution of these programs, and the like. The storage unit 35 stores, for example, a measurement target designation program 351, a measurement control program 352, a calibration curve database 353, and an original calibration curve database 354.

The measurement target designation program 351 is executed by the control unit 31 so that, for example, an operator operates the input device 33 to designate a sample to be measured or a measurement item (hereinafter sometimes simply referred to as "item"). This is the program that will be used. The control unit 31 executes the measurement target specification program 351 to set the sample and items (for example, RRA, EPA, etc.) to be measured. This measurement target designation program 351 specifies a specimen and an item as a measurement target. Here, the operator may operate the input device 33 to specify the length, time interval, time (time zone), etc. for which the sample measurement is to be performed, or when specifying the sample or item. A predetermined length, time interval, time, etc. may be automatically set depending on the specimen or item. Then, the control section 31 creates a measurement setting table (not shown) based on the contents specified by the measurement target specification program 351, and stores it in the storage section 35.

The measurement control program 352 is a program executed by the control unit 31 in order to measure a designated specimen or item. The control unit 31 reads the contents of the operation stored in the measurement setting table (not shown), and executes the operation (measurement of the sample or item to be measured) based on the read contents of the operation. Note that when receiving an instruction to start measurement from the input device 33, the control unit 31 immediately starts measurement.

The calibration curve database 353 (an example of a first storage area) stores a copy calibration curve in which part of the reagent information of a previously created calibration curve is rewritten. The copy calibration curve is a calibration curve that has the same values used for concentration calculation as the original calibration curve (original calibration curve) created by measuring a standard sample, but has different reagent information (reagent container information in this embodiment). The reagent information includes at least either reagent lot information or reagent container information (for example, an identifier such as a serial number). Note that the reagent information may include other information, such as the expiration date of the reagent. The calibration curve database 353 also stores an original calibration curve (original calibration curve) created by measuring a standard sample. The calibration curve database 353 can also be called a calibration curve DB that stores calibration curves used in the past.

The original calibration curve database 354 (an example of a second storage area) stores an original calibration curve (original calibration curve) created by measuring a standard sample. In the following, the calibration curve database will be referred to as "calibration curve DB" and the original calibration curve database will be referred to as "original calibration curve DB."

In the example of FIG. 2, the calibration curve DB 353 and the original calibration curve DB 354 are provided in the same storage section 35, but they may be provided in different storage sections.

The temporary storage unit 36 is composed of a RAM such as a flash memory that can be updated and stored. The temporary storage section 36 temporarily stores programs and data read out from the storage section 35 by the control section 31, setting contents of some or all of various tables, measurement results, and the like.

The clock section 37 measures the time and notifies the control section 31 of the time. The clock section 37 uses a real time clock (RTC), which is an IC that outputs current date and time information, and is installed in, for example, a general personal computer. Any other information that uniquely identifies the time series may be used, such as a count value of a clock signal.

[Standard sample measurement processing]
Next, the procedure of standard sample measurement processing by the automatic analyzer 1 will be explained with reference to FIG. 3.
FIG. 3 is a flowchart showing an example of a standard sample measurement process performed by the automatic analyzer 1.
First, the control unit 31 measures a target standard sample using the measurement mechanism 1A (S1), and creates an original calibration curve based on the measurement results (S2). Then, the control unit 31 stores the created original calibration curve in the calibration curve DB 353 of the storage unit 35 (S3). Further, the control unit 31 stores the created original calibration curve in the original calibration curve DB 354 of the storage unit 35 (S4).

In this way, the original calibration curve created by measuring the standard sample is stored in the calibration curve DB 353 in addition to the original calibration curve DB 354 . As will be described in detail with reference to FIG. 4, when measuring a specimen (for example, a patient specimen) in this embodiment, first a calibration curve that can be used for concentration calculation is searched from the calibration curve DB 353. If the calibration curve DB 353 is searched and the target calibration curve is not found, then the original calibration curve DB 354 is searched.

[Patient sample measurement processing]
Next, the procedure of patient sample measurement processing by the automatic analyzer 1 will be explained with reference to FIG. 4.
FIG. 4 is a flowchart illustrating an example of a procedure for patient sample measurement processing by the automatic analyzer 1.
First, the control unit 31 reads and executes the measurement control program 352 to measure the desired measurement item on the patient specimen (S11). Next, the calibration curve search unit 311 of the control unit 31 searches the calibration curve DB 353 for a calibration curve to be used for measuring the target measurement item (S12).

Next, the calibration curve search unit 311 determines whether the calibration curve DB 353 has a calibration curve that can be used to calculate the concentration of the target measurement item, that is, a calibration curve for the same measurement item as the target measurement item (S13).

Next, if there is a calibration curve in the calibration curve DB 353 that can be used to calculate the concentration of the target measurement item (YES in S13), the calibration curve search unit 311 searches the calibration curve DB 353 for the reagent used in creating the calibration curve. It is determined whether the reagent information of the reagent matches the reagent information of the reagent used for measuring the patient sample (S14). Here, the reagent information matching means that both reagent lot information and reagent container information match.

Next, if the reagent information of the reagent used to create the calibration curve and the reagent information of the reagent used to measure the patient specimen match (YES in S14), the measurement data processing unit 312 searches from the calibration curve DB 353. The existing calibration curve obtained is used for measurement (analysis) (S15). Here, the calibration curve searched from the calibration curve DB 353 is the original calibration curve or the copy calibration curve.

On the other hand, if the reagent information of the reagent used to create the searched calibration curve and the reagent information of the reagent used to measure the patient specimen do not match (NO in S14), the measurement data processing unit 312 uses the calibration curve DB 353. A copy calibration curve is created by duplicating the existing calibration curve retrieved from (S16). In this embodiment, when the reagent information does not match, it means that the reagent container information does not match and only the reagent lot information matches.

Then, the measurement data processing unit 312 stores the created copy calibration curve in the calibration curve DB 353 (S17). Thereafter, the measurement data processing unit 312 uses the copy calibration curve for measurement (analysis) of the patient sample (S18).

In the determination process of step S13, if there is no calibration curve in the calibration curve DB 353 that can be used to calculate the concentration of the target measurement item (NO in S13), the calibration curve search unit 311 searches the original calibration curve DB 354 (S19). .

Next, the calibration curve search unit 311 determines whether a calibration curve that can be used to calculate the concentration of the target measurement item, that is, a calibration curve of the same measurement item as the target measurement item, exists in the original calibration curve DB 354 (S20). .

Next, if there is a calibration curve in the original calibration curve DB 354 that can be used to calculate the concentration of the target measurement item (YES in S20), the calibration curve search unit 311 uses the calibration curve retrieved from the original calibration curve DB 354 to create the calibration curve. It is determined whether the reagent information of the reagent used to measure the patient sample matches the reagent information of the reagent used to measure the patient sample (S21).

Next, if the reagent information of the reagent used to create the calibration curve and the reagent information of the reagent used to measure the patient specimen match (YES in S21), the measurement data processing unit 312 retrieves the data from the original calibration curve DB 354. The searched existing calibration curve (original calibration curve) is used for measurement (S22). In this way, the measurement data processing unit 312 automatically uses the original calibration curve stored in the original calibration curve DB 354 for processing the measurement data.

On the other hand, if the reagent information of the reagent used to create the searched calibration curve and the reagent information of the reagent used to measure the patient specimen do not match (NO in S21), the measurement data processing unit 312 processes the original calibration curve. A copy calibration curve is created by duplicating the calibration curve (original calibration curve) retrieved from the DB 354 (S23). Here, when the reagent information does not match, it means that the reagent container information does not match and only the reagent lot information matches, as in step S14.

Then, the measurement data processing unit 312 stores the created copy calibration curve in the calibration curve DB 353 (S17). Thereafter, the measurement data processing unit 312 controls the copy calibration curve to be used for measurement (analysis) of the patient sample (S18).

In this embodiment, the analysis section 32 applies the above-mentioned calibration curve to the measurement result by the multi-wavelength photometer 16 to analyze the component concentration of the patient sample, but the measurement data processing section 312 applies the above-mentioned calibration curve It may also be configured to analyze the component concentration, etc. of a patient sample using the following.

Further, in step S20, if there is no calibration curve in the original calibration curve DB 354 that can be used to calculate the concentration of the target measurement item (NO in S20), the calibration curve search unit 311 determines that there is no calibration curve and performs a predetermined process. (S24). For example, the calibration curve search unit 311 (control unit 31) displays an error message indicating that there is no corresponding calibration curve on the display device 34, and waits for an instruction from the operator. Alternatively, the calibration curve search unit 311 (control unit 31) skips the measurement of the target measurement item for the relevant patient specimen and proceeds to measurement of another measurement item. Alternatively, the calibration curve search unit 311 (control unit 31) skips the measurement of the relevant patient sample for the target measurement item, and performs the measurement of other patient samples.

After the process of step S15, S18, S22, or S24 is finished, the process of this flowchart is finished.

[Specific examples of standard sample measurement and patient sample measurement]
Next, a specific example of standard sample measurement and patient sample measurement using the automatic analyzer 1 will be described with reference to FIG.
FIG. 5 shows a specific example of standard sample measurement and patient sample measurement by the automatic analyzer 1. FIG. 5 shows the measurement target, the reagent used, the information held in the calibration curve DB according to the prior art, and the information held in each of the calibration curve DB 353 and the original calibration curve DB 354 according to the present invention, in a step-by-step manner of measurement.

-Conventional technology-
First, a conventional technique for measuring a certain measurement item will be explained. In the prior art, there is only one database that stores calibration curves.

(Step 1)
When a standard sample is measured using the reagent of lot A, a calibration curve A (Org) is created in the calibration curve DB. "Calibration curve A" means a calibration curve created using reagents of lot A, and "Org" means an original calibration curve. To simplify the explanation, the calibration curve DB includes a storage area that stores information for 10 calibration curves.

(Step 2)
Next, when the standard sample is measured using the reagent of lot B, a calibration curve B (Org) is created in the calibration curve DB.

(Step 3)
Next, when a patient sample is measured using the reagent of lot B_1 (some of the reagent information is different from lot B), a copy calibration curve B (Copy1) is created by copying the information of calibration curve B (Org) and changing the reagent information. ) is created in the calibration curve DB. The different reagent information is reagent container information, and a copy calibration curve is created after changing the reagent container information. Here, the reagent container information is "1".

(Step 4)
When the operation in Step 3 is repeated up to the reagent of lot B_9, copy calibration curves B (Copy1) to B (Copy9) are created, and the calibration curve A (Org) disappears from the calibration curve DB.

(Step 5)
Next, when a patient sample is measured using the reagent of lot A_1, since the calibration curve A does not exist in the calibration curve DB, it is determined that there is no calibration curve. The above is a description of specific examples of the prior art.

-This invention-
Next, a specific example of the present invention in the case of measuring a certain measurement item will be described. In the present invention, there are a calibration curve DB 353 and an original calibration curve DB 354 as databases for storing calibration curves. In the present invention, it is desirable to prepare a calibration curve DB 353 and an original calibration curve DB 354 for each measurement item.

(Step 1)
When a standard sample is measured using the reagent of lot A, a calibration curve A (Org) is created in the calibration curve DB (calibration curve DB 353) and the original calibration curve DB (original calibration curve DB 354). To simplify the explanation, the calibration curve DB and the original calibration curve DB each include a storage area that stores information for five calibration curves.

(Step 2)
Next, when the standard sample is measured using the reagent of lot B, a calibration curve B (Org) is created in the calibration curve DB and the original calibration curve DB.

(Step 3)
Next, when a patient sample is measured using the reagent of lot B_1 (some of the reagent information is different from lot B), a copy calibration curve B (Copy1) is created by copying the information of calibration curve B (Org) and changing the reagent information. ) is created in the calibration curve DB. Here, the different reagent information is reagent container information, as in the case of the prior art, and a copy calibration curve is created after changing the reagent container information.

(Step 4)
When the operation in Step 3 is repeated up to the reagent of lot B_9, copy calibration curves B (Copy 1) to B (Copy 9) are created, and calibration curves A (Org), B (Org), B (Copy 1) to B are created from the calibration curve DB. (Copy4) disappears.

(Step 5)
Next, when a patient specimen is measured using the reagent of lot A_1, a copy calibration curve A (Copy1) is created in the calibration curve DB by copying the information of the calibration curve A (Org) in the original calibration curve DB. Thereby, for the measurement using the reagent of lot A_1, the components of the measurement items of the patient sample can be measured by applying the copy calibration curve A (Copy1) to the measurement data. The above is a description of specific examples of the present invention.

As described above, the automatic analyzer according to the first embodiment includes a first storage area, a second storage area, a calibration curve search section, and a measurement data processing section.
The first storage area (for example, the calibration curve DB 353) is configured to store a copy calibration curve in which part of the reagent information (for example, reagent lot information, reagent container information) of the created calibration curve is rewritten.
The second storage area (for example, original calibration curve DB 354) is configured to store an original calibration curve (original calibration curve) created by measuring a standard sample.
The calibration curve search unit (for example, the calibration curve search unit 311) searches the calibration curve stored in at least one of the first storage area and the second storage area when searching for a calibration curve to be used in processing sample measurement data. The reagent lot information and reagent container information as the reagent information of the line are compared with the reagent lot information and reagent container information of the reagent used for sample measurement.
When the calibration curve search unit searches for a calibration curve in which the reagent container information does not match and only the reagent lot information matches, the measurement data processing unit (for example, the measurement data processing unit 312) searches for reagents in the reagent information of the calibration curve. After the container information is rewritten to the reagent container information of the reagent used for specimen measurement, the calibration curve is used for processing the specimen measurement data.

According to the automatic analyzer according to the first embodiment having the above configuration, traceability of measurement results (a function that allows you to confirm which reagent container was used for measurement) can be achieved without requiring a large storage area. It is possible to store information on a sufficient number of calibration curves for operation. Therefore, efficient measurement of the sample is possible.

Further, in the first embodiment, a calibration curve obtained by rewriting reagent container information from a calibration curve with matching reagent lot information among the reagent container information, that is, a copy calibration curve is used for processing sample measurement data. Since a copy calibration curve with rewritten reagent container information is automatically created and saved in the first storage area, the operator is less likely to experience stress during operations. Therefore, according to this embodiment, traceability of measurement results can be ensured while stress-free operability is maintained.

Furthermore, in the first embodiment, the original calibration curve DB that stores the original calibration curve is provided separately from the calibration curve DB that stores the copy calibration curve, so the copy calibration curve and the original calibration curve are stored in one database. The storage period of the original calibration curve is longer than that in the previous case. Therefore, there are more options for when to perform calibration, and operators can use their time more effectively.

Further, in the automatic analyzer according to the present embodiment, the calibration curve search unit (for example, the calibration curve search unit 311) first stores the first storage area (the calibration curve DB 353) before the second storage area (the original calibration curve DB 354). ), and if a calibration curve usable for processing the sample measurement data is not found, the second storage area is searched.

In actual operation, even if the reagent lot information is the same among the reagent information, there are many cases where the reagent container information is different, that is, there are many cases where a copy calibration curve is created. Therefore, by first searching the first storage area where the copy calibration curve can be stored, there is a possibility that the search time can be shortened.

In addition, in the automatic analyzer according to this embodiment, the first storage area (calibration curve DB 353) and the second storage area (original calibration curve DB 354) have an upper limit number of calibration curves that can be stored, as shown in FIG. When the calibration curve is reached, the oldest calibration curve is deleted and the latest calibration curve is stored.

With the above configuration, even if an original calibration curve or a copy calibration curve is newly created as a calibration curve, the latest calibration curve can be stored in the first storage area or the second storage area at any time.

<Second embodiment>
The second embodiment stores original calibration curves and copy calibration curves for a plurality of measurement items in one storage area, and stores a calibration curve DB and an original calibration curve in the automatic analyzer 1 according to the first embodiment. The calibration curve DB has a cache function. With this cache function, the control unit 31 saves the information of the calibration curves stored together in one storage area in another storage area for each measurement item, so that the information on the calibration curve can be Quickly access line information.

FIG. 6 is a block diagram showing an example of the internal configuration of the automatic analyzer 1 according to the second embodiment.
The automatic analyzer 1 shown in FIG. 6 is the same as the automatic analyzer 1 (FIG. 2) according to the first embodiment, in which a total calibration curve database 355 and cache calibration curve databases 356X to 356Z are stored in the storage unit 35. There is.

The total calibration curve database 355 (an example of the entire storage area) stores a copy calibration curve in which part of the reagent information (lot information, container information, etc.) of the previously created calibration curve has been rewritten under the control of the control unit 31; An original calibration curve (original calibration curve) created by measuring a standard sample is stored. In the following description, the entire calibration curve database will be referred to as "calibration curve DB_ALL."

The cache calibration curve databases 356X to 356Z (item-specific storage areas) store information indicating the storage location of the copy calibration curve and the original calibration curve in the total calibration curve DB 355 for each measurement item under the control of the control unit 31. do. Each of the cache calibration curve databases 356X to 356Z includes a calibration curve DB and an original calibration curve DB. In the following description, the cache calibration curve database will be referred to as "cache calibration curve DB."

The calibration curve DB (first item-specific storage area) stores information indicating the storage location of the copy calibration curve in the calibration curve DB_ALL 355 for each measurement item when the copy calibration curve is stored in the calibration curve DB_ALL 355. . Further, in this embodiment, the calibration curve DB stores information indicating the storage location in the calibration curve DB_ALL 355 of an original calibration curve created by measuring a standard sample. The information indicating the storage location is, for example, an address in the memory space of the storage unit 35 that stores the calibration curve DB_ALL 355. This address may be either a physical address or a logical address.

The original calibration curve DB (second storage area for each item) stores information indicating the storage location of the original calibration curve in the calibration curve DB_ALL 355 for each measurement item when the original calibration curve is stored in the calibration curve DB_ALL 355. do.

Although the calibration curve DB_ALL 355 and the cache calibration curves DB 356X to 356Z are provided in the same storage unit 35, some or all of the DBs may be provided in different storage units.

FIG. 7 shows a specific example of patient sample measurement in the second embodiment.
A calibration curve DB_ALL 355 is shown on the left side of FIG. Further, on the right side of FIG. 7, a cache calibration curve DB 356X for measurement item X, a cache calibration curve DB 356Y for measurement item Y, and a cache calibration curve DB 356Z for measurement item Z are shown. In the figure, the solid line represents the memory address storage process, and the broken line represents the access process to the calibration curve based on the memory address.

The calibration curve DB_ALL 355 shows calibration curve data and information on the memory address where the calibration curve data is stored. The calibration curve DB_ALL 355 stores original calibration curves and copy calibration curves for measurement items (items in FIG. 7) X to Y. A to D represent lot information. Further, the subscript attached to Copy indicates that the original calibration curve and container information are different. For example, "Item Y (Org)_A" at position "1" in the memory space represents an original calibration curve created using reagent of lot "A" for item Y. Furthermore, “Item Z (Copy1)_B” at position “15” represents a copy calibration curve created for item Z using a reagent contained in a container with lot “B” and container information “1”.

The cache calibration curve DBs 356X to 356Z each indicate the memory address of the calibration curve of the calibration curve DB_ALL 355 for accessing the information on the calibration curve used to measure the corresponding measurement item. In the example of FIG. 7, in the cache calibration curve DB 356X, memory addresses "13", "14", and "17" are written in the calibration curve DB, and memory addresses "2", "3", and "9" are written in the original calibration curve DB. ” is written.

As described above, the automatic analyzer according to the second embodiment includes an overall storage area, a first storage area for each item, a second storage area for each item, a calibration curve search unit, and a measurement data processing unit. It consists of
The entire storage area (for example, the entire calibration curve database 355) is created by measuring a copy calibration curve in which part of the reagent information (for example, reagent lot information, reagent container information) of the already created calibration curve is rewritten, and standard samples. It is configured to store an original calibration curve (original calibration curve).
The first item-specific storage area (for example, calibration curve DB) stores information (memory address).
The second item-specific storage area (for example, original calibration curve DB) stores information indicating the storage location of the original calibration curve in the overall storage area for each measurement item when the original calibration curve is stored in the overall storage area. configured to remember.
When searching for a calibration curve to be used in processing sample measurement data, the calibration curve search unit (for example, the calibration curve search unit 311) stores at least a first item-specific storage area corresponding to the measurement item of the calibration curve to be searched; The entire storage area is searched based on the information in any of the second itemized storage areas, and the reagent lot information and reagent container information as reagent information of the calibration curve stored in the overall storage area and the reagent container information used for sample measurement are retrieved. It is configured to compare reagent lot information and reagent container information of the reagent.
When the calibration curve search unit searches for a calibration curve in which the reagent container information does not match and only the reagent lot information matches, the measurement data processing unit (for example, the measurement data processing unit 312) searches for reagents in the reagent information of the calibration curve. After the container information is rewritten to the reagent container information of the reagent used for specimen measurement, the calibration curve is used for processing specimen measurement data.

According to the automatic analyzer according to the second embodiment having the above configuration, in addition to the same effects as the first embodiment, the following effects are achieved. In this embodiment, the storage area for the calibration curve (all calibration curve DB) is used in common for all measurement items, but the information ( (memory address) is held separately. In this way, by providing a cache function that extracts a calibration curve for each measurement item, it is possible to speed up access to a target calibration curve.
<Modified example>

Furthermore, the present invention is not limited to the embodiments described above, and it goes without saying that various other applications and modifications can be made without departing from the gist of the present invention as set forth in the claims. . For example, each of the embodiments described above describes the configuration of an automatic analyzer in detail and specifically in order to explain the present invention in an easy-to-understand manner, and is not necessarily limited to having all the described components. Further, it is also possible to add, replace, or delete other components to a part of the configuration of each embodiment.

Further, each of the configurations, functions, processing units, etc. described above may be partially or entirely realized in hardware by designing, for example, an integrated circuit. As the hardware, a broadly defined processor device such as an FPGA (Field Programmable Gate Array) or an ASIC (Application Specific Integrated Circuit) may be used.

Furthermore, in the flowcharts shown in FIGS. 3 and 4, a plurality of processes may be executed in parallel or the processing order may be changed within a range that does not affect the processing results.

DESCRIPTION OF SYMBOLS 1... Automatic analyzer, 2... Sample turntable, 2a... Calibrator, 2b... Control, 30... Calculator, 31... Control section, 33... Input device, 34... Display device, 35... Storage section, 36... Temporary storage section, 311...Calibration curve search unit, 312...Measurement data processing unit, 353...Calibration curve database, 354...Original calibration curve database, 355...All calibration curve database, 356X to 356Z...Cache calibration curve database

Claims (4)

a first storage area for storing a copy calibration curve in which part of the reagent information of the created calibration curve has been rewritten;
a second storage area that stores an original calibration curve created by measuring standard samples;
When searching for a calibration curve to be used in processing sample measurement data, reagent lot information and reagent containers are used as reagent information of the calibration curve stored in at least either the first storage area or the second storage area. a calibration curve search unit that compares the information with reagent lot information and reagent container information of the reagent used for sample measurement;
When the calibration curve search unit searches for a calibration curve in which the reagent container information does not match and only the reagent lot information matches, the reagent container information of the reagent information of the calibration curve is used to identify the reagent used for sample measurement. a measurement data processing unit that rewrites the reagent container information and uses the calibration curve to process sample measurement data ;
The calibration curve in which the reagent container information has been rewritten by the measurement data processing unit is stored in the first storage area as the copy calibration curve,
The calibration curve search unit searches the first storage area before the second storage area, and searches the second storage area if a calibration curve usable for processing the sample measurement data is not found. Search storage space
Automatic analyzer. The automatic analyzer according to claim 1 , wherein an original calibration curve created by measuring a standard sample is stored in the second storage area and the first storage area. The automatic analyzer according to claim 2 , wherein the first storage area and the second storage area erase the oldest calibration curve and store the latest calibration curve when the upper limit number of calibration curves that can be stored is reached. . a procedure for storing a copy calibration curve in which part of the reagent information of the created calibration curve has been rewritten in a first storage area;
a procedure for storing an original calibration curve created by measuring a standard sample in a second storage area;
When searching for a calibration curve to be used in processing sample measurement data, reagent lot information and reagent containers are used as reagent information of the calibration curve stored in at least either the first storage area or the second storage area. a procedure for comparing the information with reagent lot information and reagent container information of the reagent used for sample measurement;
If a calibration curve in which the reagent container information does not match and only the reagent lot information matches is found, the reagent container information in the reagent information of the calibration curve is rewritten to the reagent container information of the reagent used for sample measurement. and the procedure for using the calibration curve in processing the sample measurement data;
a step of storing the calibration curve in which the reagent container information has been rewritten in the first storage area as the copy calibration curve;
In the comparing step, the first storage area is searched before the second storage area, and if a calibration curve that can be used for processing the sample measurement data is not found, the second storage area is searched. The steps to search for an area are as follows:
A program that runs on a computer.

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