JP7326205B2 - automatic analyzer - Google Patents

Description

The present invention relates to an automatic analyzer for analyzing specimens.

Automatic analyzers are used to measure the concentration of specific components contained in specimens such as blood and urine. More specifically, the absorbance measured with respect to the reaction solution in which the specimen and the reagent are reacted is converted into the concentration of the specific component using a calibration curve prepared in advance. The calibration curve is created by performing calibration including measuring the absorbance of a reaction solution in which a standard solution having a known concentration of a specific component and a reagent are allowed to react.

Also, in order to confirm the reliability of the measurement values of the automatic analyzer and the reaction state of the reaction solution, an allowable range for the calibration measurement results is set in advance. The allowable range is used to determine whether the calibration measurement result is abnormal. Since the reaction characteristics of reagents differ depending on the manufacturing lot, it is desirable to set the allowable range for each reagent lot.

Patent Document 1 discloses an automatic analyzer that sets a different allowable range for each reagent lot based on reagent information indicated on a reagent container containing the reagent. The permissible range for each reagent lot is acquired, for example, from a reagent manufacturer's server connected via a communication network.

JP 2012-107985 A

However, in Patent Document 1, the allowable range is only set for each reagent lot, and an excessively wide allowable range may be set. If the set allowable range is too wide, it may not be possible to determine an abnormality in the calibration measurement result, which may reduce the reliability of the calibration measurement result.

SUMMARY OF THE INVENTION Accordingly, it is an object of the present invention to provide an automatic analyzer that improves the reliability of calibration measurement results.

In order to achieve the above object, the present invention provides an automatic analyzer for analyzing a sample, comprising: an analysis unit that performs calibration measurement and then analyzes the sample; a storage unit for storing accumulated data, which is obtained data; a calculation unit for calculating, based on the accumulated data, an allowable range used for determining whether or not a measurement result of calibration is abnormal; and It is characterized by comprising a display unit for displaying.

ADVANTAGE OF THE INVENTION According to this invention, it becomes possible to provide the automatic analyzer which improves the reliability of the measurement result of calibration.

It is a figure explaining an example of a structure of an automatic analyzer. FIG. 10 is a diagram showing an example of the flow of calculation/display processing of an allowable range for calibration measurement results; It is an example of a screen for selecting whether to store calibration measurement results. FIG. 10 is a diagram showing an example of a flow of calculation processing of an allowable range based on accumulated data; It is an example of a screen for setting various conditions for calculating the allowable range. It is an example of a screen displaying a calculated allowable range.

Preferred embodiments of the automatic analyzer according to the present invention will be described below with reference to the accompanying drawings. In the following description and accompanying drawings, constituent elements having the same functional configuration are denoted by the same reference numerals, thereby omitting redundant description.

An example of the configuration of an automatic analyzer that analyzes a specimen will be described with reference to FIG. The automatic analyzer includes an analysis section 1 , a storage section 14 , a display section 15 , an operation section 16 and a control section 17 . The analysis section 1 has a transport line 4 , a sample probe 5 , a reagent probe 6 , a reagent disk 8 , a reaction disk 10 , a stirring section 11 , a photometer 12 and a washing section 13 .

The transport line 4 transports the sample rack 3 on which a plurality of sample containers 2 containing samples such as blood and urine are mounted to a position accessible by the sample probe 5 . Note that the sample rack 3 and the transport line 4 may be replaced by sample disks that rotate to move the sample containers 2 that are mounted in a ring. The reagent disk 8 stores a plurality of reagent containers 7 containing reagents to be reacted with the specimen, and rotates to move the reagent containers 7 to positions accessed by the reagent probes 6 . The reaction disk 10 circularly holds a plurality of reaction vessels 9 into which specimens and reagents are dispensed, and rotates to move the reaction vessels 9 to predetermined positions. The sample probe 5 dispenses the sample from the sample container 2 mounted on the sample rack 3 transported by the transport line 4 to the reaction container 9 . The reagent probe 6 dispenses the reagent from the reagent container 7 into the reaction container 9 into which the specimen has been dispensed. Note that the number of reagents to be dispensed into the reaction container 9 is not limited to one, and a plurality of reagents may be dispensed. The stirring unit 11 is arranged around the reaction disk 10 and stirs the inside of the reaction container 9 into which the sample and the reagent are dispensed.

A photometer 12 is arranged around the reaction disk 10 and measures the absorbance of the solution in the reaction container 9 stirred by the stirring unit 11 each time the reaction container 9 passes in front. The measured absorbance is converted to the concentration of the specific component contained in the specimen using a calibration curve prepared in advance. The calibration curve is created by performing calibration including measuring the absorbance of a reaction solution in which a standard solution having a known concentration of a specific component and a reagent are allowed to react. The cleaning unit 13 is arranged around the reaction disk 10 and cleans the reaction vessel 9 for which analysis has been completed.

A standard solution used for calibration is a solution containing a specific component. A standard solution in which the concentration of the specific component is substantially zero and does not react with the reagent is called a first standard solution, and in many cases, it is physiological saline, purified water, or the like.

The storage unit 14 is, for example, a HDD (Hard Disk Drive) or SSD (Solid State Drive), and stores the absorbance measured by the photometer 12, the concentration converted from the absorbance, and the like. The display unit 15 is, for example, a liquid crystal display or a touch panel, and displays absorbance, concentration, screens described later with reference to FIGS. 3, 5 and 6, and the like. The operation unit 16 is, for example, a keyboard and a mouse, and performs operations such as input of conditions and parameters required for analysis. Note that when the display unit 15 is a touch panel, a GUI (Graphical User Interface) displayed on the touch panel functions as the operation unit 16 . The control unit 17 is a computing unit such as a CPU (Central Processing Unit), for example, and controls each unit and executes various computations.

By the way, in order to confirm the reliability of the measurement value of the automatic analyzer and the reaction state of the reaction liquid, an allowable range used for determining whether the calibration measurement result is abnormal or not is set in advance. If the set allowable range is excessively wide, it may not be possible to determine an abnormality in the calibration measurement result, which may reduce the reliability of the calibration measurement result. Therefore, in this embodiment, the control unit 17 calculates the allowable range based on accumulated data, which is data obtained by accumulating calibration measurement results. That is, the control unit 17 functions as a calculation unit that calculates, based on the accumulated data, the allowable range used for determining whether the measurement result of calibration is abnormal. Since the allowable range calculated based on the accumulated data is appropriately narrowed, the reliability of the calibration measurement results is improved.

With reference to FIG. 2, an example of the processing flow of the present embodiment, that is, the flow of calculation and display processing of the allowable range for the measurement result of calibration will be described step by step.

(S201)
The control unit 17 causes the analysis unit 1 to perform calibration. Execution of calibration is performed by a request from an operator or a recommendation request from an automatic analyzer.

An example of a screen for requesting calibration and a screen for the operator to select whether or not to store the calibration measurement results will be described with reference to FIG. The screen illustrated in FIG. 3 has an evaluation mode area 30, a position area 31, an item area 32, a factor area 33, an execution method area 34, and a request button 35. The rows of the table on the screen correspond to the calibration measurement items.

The evaluation mode area 30 displays a check box for selecting whether or not to store the calibration measurement results. In other words, the measurement results of lines with check boxes are accumulated.

In the position area 31 and the item area 32, the mounting position in the reagent disk 8 of the reagent container 7 mounted on the automatic analyzer and the item name of the reagent container 7 are displayed, respectively. The factor area 33 displays whether the calibration measurement item is requested by the operator or is requested by the automatic analyzer. On the screen of FIG. 3, the operator's request is displayed as "manual", and "reagent replacement" is displayed as an example of the recommendation request from the automatic analyzer. In the execution method area 34 a calibration method is selected. If the measurement item for calibration is a recommendation request from the automatic analyzer, a preset calibration method is displayed in the execution method area 34 . The request button 35 is used when the operator requests the automatic analyzer to perform calibration.

The operator selects in the evaluation mode area 30 which calibration measurement results are to be accumulated based on the result of checking the display contents of the position area 31, item area 32, factor area 33, and execution method area 34. . Further, when the calibration method is selected in the execution method area 34 and the request button 35 is pressed, the request for calibration to the automatic analyzer is completed, and the calibration is performed according to the request. The analysis unit 1 performs multiple measurements in which the same measurement is performed multiple times for the requested calibration.

(S202)
The control unit 17 determines whether or not to accumulate the measurement results of the calibration performed in S201. If it is to be stored, the process proceeds to S203, and if it is not to be stored, the process proceeds to S204. Whether or not to store the calibration measurement results may be determined based on the selection made by the operator on the screen illustrated in FIG. Also, based on the login ID of the operator, the measurement results of the calibration requested by the same operator may be accumulated for each operator. It should be noted that all the measurement results of calibration may be accumulated without determining whether or not to accumulate them.

(S203)
The storage unit 14 stores the measurement result of the calibration performed in S201 as one of accumulated data.

(S204)
The control unit 17 determines whether or not there are a plurality of accumulated data stored in the storage unit 14 . If there is a plurality of stored data, the process proceeds to S205, and if not, the process proceeds to S206.

(S205)
The control unit 17 calculates the allowable range based on the accumulated data.

An example of the processing flow of this step will be described step by step with reference to FIG.

(S401)
The control unit 17 reads the accumulated data A _(i) from the storage unit 14 . Accumulated data A _(i) is a physical quantity such as absorbance obtained as a result of calibration measurement. i is an index of accumulated data A _(i) and ranges from 1 to N, where N is the number of target accumulated data. Various conditions may be set in calculating the allowable range based on the accumulated data.

An example of a screen for setting various conditions for calculating the allowable range will be described with reference to FIG. The screen illustrated in FIG. 5 has a basic setting area 50 and an update button 54 , and the basic setting area 50 includes a period management area 51 , a reagent lot management area 52 and a management width area 53 . A period management area 51, a reagent lot management area 52, and a management width area 53 are set for each measurement item.

In the period management area 51, whether or not to manage the accumulated data A _(i) read from the storage unit 14 by period is selected from a pull-down menu including "manage" and "not manage". When managing by period, the period is further specified. By specifying the period of the accumulated data A _(i) , it is possible to calculate the allowable range separately according to, for example, before and after maintenance of the automatic analyzer, the frequency of use of the automatic analyzer, etc. . By dividing before and after the maintenance, even if the state of the automatic analyzer changes due to the maintenance, the allowable range can be set for the accumulated data after the maintenance is performed.

In the reagent lot management area 52, whether or not to manage the accumulated data A _(i) read from the storage unit 14 by reagent lot is selected from a pull-down menu including "manage" and "not manage". When the accumulated data A _(i) is managed by reagent lot, the accumulated data is classified for each reagent lot, and the allowable range can be set for each reagent lot.

In the control width area 53, the control width of the allowable range is selected from the pull-down menu for each check item of each measurement item. The screen illustrated in FIG. 5 includes “1SD”, “2SD”, and “3SD” as control range options. The check items include the absorbance range of the first standard solution, allowable absorbance for variation, allowable absorbance for sensitivity, and allowable absorbance for convergence.

The first standard solution absorbance range is the allowable range of absorbance of the reaction solution between the first standard solution and the reagent. Since the first standard solution is a transparent liquid and does not react with the reagent, and the color tone of the reagent is reflected in the absorbance of the first standard solution, deterioration of the reagent can be confirmed by the absorbance of the first standard solution. The permissible absorbance variation is the upper limit of the difference between multiple absorbances obtained by multiple measurements of standard solutions. Sensitivity allowable absorbance is the sensitivity obtained from the absorbance of the first standard solution, the absorbance of the reaction solution of the standard solution other than the first standard solution and the reagent, and the concentration of each standard solution, that is, the allowable range of the slope of the calibration curve is. The permissible convergence absorbance is a non-linear calibration curve that is a curve or polygonal calibration curve, and a multi-point linear calibration curve that is a calibration curve that linearly approximates a combination of three or more absorbances and concentrations. is the upper limit of the standard deviation of the difference between the calculated absorbances.

The update button 54 is a button used when updating various conditions for calculating the allowable range. When the operator presses the update button 54 after setting various conditions in the period management area 51, the reagent lot management area 52, and the management width area 53, the various conditions are updated.

(S402)
The control unit 17 determines whether or not a period is specified for the accumulated data A _(i) . Whether or not the period is designated is determined based on the selection in the period management area 51 of the screen shown in FIG. 5, for example. That is, if "manage" is selected and a period is specified in the period management area 51, it is determined that the period is specified, otherwise it is determined that the period is not specified. If the period is specified, the process proceeds to S403; otherwise, the process proceeds to S404.

(S403)
The control unit 17 uses the accumulated data A _(i) of the specified period in the processing after this step.

(S404)
The control unit 17 uses the accumulated data A _(i) for the entire period in the processing after this step.

Note that the processes of S402 to S404 are not essential and may be omitted. By omitting the processes of S402 to S404, operations by the operator are reduced.

(S405)
The control unit 17 determines whether or not to manage the accumulated data A _(i) by reagent lot. Whether or not to manage by reagent lot is determined based on selection in the reagent lot management area 52 on the screen shown in FIG. 5, for example. That is, in the reagent lot management area 52, if "manage" is selected, it is determined that the reagent lot is managed, and if "not managed" is selected, it is determined that the reagent lot is not managed. If the reagent lot is to be managed, the process proceeds to S406; otherwise, the process proceeds to S407.

(S406)
The control unit 17 manages the accumulated data A _(i) for each reagent lot in the processes after this step.

(S407)
The control unit 17 manages the accumulated data A _(i) for each measurement item in the processes after this step.

Note that the processes of S405 to S407 are not essential and may be omitted. By omitting the processing of S405 to S407, operations by the operator are reduced.

(S408)
The control unit 17 calculates an average value A _average of target accumulated data A _(i) . For example, the following equation is used to calculate the average value A _average .

(S409)
The control unit 17 calculates a standard deviation SD (Standard Deviation) of the target accumulated data A _(i) . For example, the following equation is used to calculate the standard deviation SD.

(S410)
The control unit 17 calculates the allowable range with the designated control range for each check item. The allowable range is, for example, a range defined by an upper limit value or a lower limit value calculated by the following formula.

Note that n is a natural number, such as 1, 2, or 3. The value of n is set, for example, based on selection in the control width area 53 of the screen shown in FIG. That is, in the management width area 53, n=1 is set if "1SD" is selected, and n=2 if "2SD" is selected. By selecting an allowable control width in the control width area 53 of the screen illustrated in FIG. 5, the allowable range is calculated according to the control width for each medical facility. Note that if the conditions are not set on the screen illustrated in FIG. 5, a predetermined value such as 2 may be set for n.

Returning to the description of FIG.

(S206)
The control unit 17 sets the permissible range presented by the reagent manufacturer. The allowable range presented by the reagent maker is downloaded from the reagent maker's website or the like based on the reagent lot or the like.

(S207)
The control unit 17 causes the display unit 15 to display the allowable range calculated in S205 or the allowable range set in S206.

An example of the allowable range display screen will be described with reference to FIG. The allowable range display screen illustrated in FIG. 6 has a reagent lot display area 60 , an allowable range display area 61 , a reset button 62 and a registration button 63 .

A reagent lot number is displayed in the reagent lot display area 60 . In the allowable range display area 61, the allowable range calculated in S205 or the allowable range set in S206 is displayed for each check item. On the screen illustrated in FIG. 6, the first standard solution absorbance range, allowable absorbance for variation, allowable absorbance for sensitivity, and allowable convergence absorbance are displayed as check items, and the allowable range for each check item is displayed for each reagent lot. If the calibration measurement result falls outside the allowable range displayed in this step, a warning is displayed on the display unit 15 . A reset button 62 is a button for resetting the allowable range displayed in the allowable range display area 61 . A registration button 63 is a button for registering the allowable range displayed in the allowable range display area 61 . That is, when the reset button 62 and the registration button 63 are successively pressed, the allowable range and accumulated data calculated in S205 are deleted.

With the flow of processing described above, the allowable range used for determining whether the calibration measurement result is abnormal is appropriately narrowed and set, so that the reliability of the calibration measurement result is improved. be done.

In addition, since the allowable range can be set based on the designated control range, each medical facility only needs to determine the control range without bothering individual operators. Furthermore, since the allowable range is calculated based on accumulated data for a specified period, even if the status of the automated analyzer changes due to maintenance, etc., the allowable range suitable for the automated analyzer after the status has changed can be set.

The embodiments of the present invention have been described above. The present invention is not limited to the above embodiments, and the constituent elements may be modified without departing from the scope of the invention. Also, a plurality of constituent elements disclosed in the above embodiments may be appropriately combined. Furthermore, some components may be deleted from all the components shown in the above embodiments.

1: Analysis Unit, 2: Sample Container, 3: Sample Rack, 4: Transfer Line, 5: Sample Probe, 6: Reagent Probe, 7: Reagent Container, 8: Reagent Disk, 9: Reaction Container, 10: Reaction Disk, 11: Stirring unit, 12: Photometer, 13: Cleaning unit, 14: Storage unit, 15: Display unit, 16: Operation unit, 17: Control unit, 30: Evaluation mode area, 31: Position area, 32: Item area , 33: factor area, 34: execution method area, 35: request button, 50: basic setting area, 51: period management area, 52: reagent lot management area, 53: control range area, 54: update button, 60: reagent Lot display area, 61: Allowable range display area, 62: Reset button, 63: Register button

Claims (8)

An automatic analyzer for analyzing a sample,
an analysis unit that analyzes the sample after performing measurements for calibration;
a storage unit for storing accumulated data, which is data obtained by accumulating measurement results of the calibration;
a calculation unit that calculates, based on the accumulated data, an allowable range used for determining whether or not the calibration measurement result is abnormal;
An automatic analyzer, comprising a display section for displaying the allowable range. The automatic analyzer according to claim 1,
The automatic analysis apparatus, wherein the calculation unit calculates the allowable range using a control range specified in advance. The automatic analyzer according to claim 2,
The automatic analyzer, wherein the control range is set using a standard deviation of the accumulated data. The automatic analyzer according to claim 3,
The automatic analyzer, wherein the allowable range is a range from a value obtained by subtracting the control range from an average value of the accumulated data to a value obtained by adding the control range to the average value. The automatic analyzer according to claim 1,
The automatic analyzer, wherein the storage unit stores data selected from measurement results of the calibration as the accumulated data. The automatic analyzer according to claim 1,
The automatic analyzer, wherein the calculation unit calculates the allowable range using accumulated data included in a period specified in advance. The automatic analyzer according to claim 1,
The automatic analyzer, wherein the calculation unit calculates the allowable range using accumulated data for each lot of reagents used for the calibration. The automatic analyzer according to claim 1,
An automatic analyzer, wherein a screen for setting a period, a reagent lot, and a control range is displayed on the display unit for each measurement item of the calibration.

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