JP2021162400A - Automatic analyzer - Google Patents

Abstract

An automatic analyzer that improves the reliability of calibration measurement results is provided. Kind Code: A1 An automatic analyzer for analyzing a sample includes an analysis section, a storage section, a calculation section, and a display section. The analysis section performs the measurement for calibration and then analyzes the sample. The storage unit stores accumulated data, which is data obtained by accumulating calibration measurement results. The calculation unit calculates, based on the accumulated data, an allowable range used for determining whether or not the calibration measurement result is abnormal. The display unit displays the calculated allowable range. [Selection drawing] Fig. 2

Description

The present invention relates to an automatic analyzer that analyzes a sample.

The automatic analyzer is used to measure the concentration of a specific component contained in a sample such as blood or urine. More specifically, the absorbance measured for the reaction solution obtained by reacting the sample and the reagent is converted into the concentration of a specific component using a calibration curve prepared in advance. The calibration curve is created by performing calibration including measurement of the absorbance of the reaction solution obtained by reacting a standard solution having a known concentration of a specific component with a reagent.

Further, in order to confirm the reliability of the measured value of the automatic analyzer and the reaction state of the reaction solution, an allowable range for the measurement result of the calibration is set in advance. The permissible range is used to determine whether or not the calibration measurement result is abnormal. Since the reaction characteristics of the reagents differ depending on the production lot, it is desirable to set the permissible range for each reagent lot.

Patent Document 1 discloses an automatic analyzer that sets different permissible ranges for each lot of reagents based on the reagent information shown in the reagent container containing the reagents. Lot-by-lot tolerances for reagents are obtained, for example, from reagent manufacturer servers connected via communication networks.

Japanese Unexamined Patent Publication No. 2012-107985

However, in Patent Document 1, the permissible range is only set for each lot of reagents, and an excessively wide permissible 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.

Therefore, an object of the present invention is to provide an automatic analyzer that improves the reliability of calibration measurement results.

In order to achieve the above object, the present invention is an automatic analyzer that analyzes a sample, and an analysis unit that analyzes the sample after making a measurement for calibration and a measurement result of the calibration are accumulated. A storage unit that stores accumulated data, which is the accumulated data, a calculation unit that calculates an allowable range used for determining whether or not the calibration measurement result is abnormal, based on the accumulated data, and the allowable range. It is characterized by including a display unit for displaying.

According to the present invention, it is possible to provide an automatic analyzer that improves the reliability of calibration measurement results.

It is a figure explaining an example of the structure of an automatic analyzer. It is a figure which shows an example of the flow of the calculation / display process of the permissible range with respect to the measurement result of calibration. This is an example of a screen for selecting whether or not to accumulate the calibration measurement results. It is a figure which shows an example of the flow of the calculation process of the permissible range based on the accumulated data. This is an example of a screen for setting various conditions for calculating the allowable range. This is an example of a screen displaying the calculated allowable range.

Hereinafter, preferred embodiments of the automatic analyzer according to the present invention will be described with reference to the accompanying drawings. In the following description and the accompanying drawings, components having the same functional configuration are designated by the same reference numerals to omit duplicate description.

An example of the configuration of an automatic analyzer that analyzes a sample will be described with reference to FIG. The automatic analyzer includes an analysis unit 1, a storage unit 14, a display unit 15, an operation unit 16, and a control unit 17. The analysis unit 1 includes a transfer line 4, a sample probe 5, a reagent probe 6, a reagent disk 8, a reaction disk 10, a stirring unit 11, a photometer 12, and a cleaning unit 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 stored to a position where the sample probe 5 accesses. The sample rack 3 and the transport line 4 may be replaced with a sample disk that rotates to move the sample container 2 mounted in a ring shape. The reagent disc 8 stores a plurality of reagent containers 7 containing reagents to be reacted with the sample, and is rotated to move the reagent container 7 to a position where the reagent probe 6 can access. The reaction disk 10 holds a plurality of reaction vessels 9 into which a sample and a reagent are dispensed in a ring shape, and rotates to move the reaction vessel 9 to a predetermined position. The sample probe 5 dispenses a sample from the sample container 2 mounted on the sample rack 3 transported by the transfer line 4 into the reaction container 9. The reagent probe 6 dispenses the reagent from the reagent container 7 into the reaction vessel 9 into which the sample is dispensed. The number of reagents dispensed into the reaction vessel 9 is not limited to one, and may be plural. The stirring unit 11 is arranged around the reaction disk 10 and stirs in the reaction vessel 9 in which the sample and the reagent are dispensed.

The photometer 12 is arranged around the reaction disk 10 and measures the absorbance of the solution in the reaction vessel 9 stirred by the stirring unit 11 each time the reaction vessel 9 crosses the front. The measured absorbance is converted into the concentration of a specific component contained in the sample using a calibration curve prepared in advance. The calibration curve is created by performing calibration including measurement of the absorbance of the reaction solution obtained by reacting a standard solution having a known concentration of a specific component with a reagent. The cleaning unit 13 is arranged around the reaction disk 10 and cleans the reaction vessel 9 for which the analysis has been completed.

The standard solution used for calibration is a solution containing a specific component. A standard solution in which the concentration of a 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, an HDD (Hard Disk Drive) or an 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 the absorbance and concentration, a screen described later with reference to FIGS. 3, 5, and 6. The operation unit 16 is, for example, a keyboard or a mouse, and performs operations such as inputting conditions and parameters necessary for analysis. When the display unit 15 is a touch panel, the GUI (Graphical User Interface) displayed on the touch panel functions as the operation unit 16. The control unit 17 is, for example, an arithmetic unit such as a CPU (Central Processing Unit), which controls each unit and executes various operations.

By the way, in order to confirm the reliability of the measured value of the automatic analyzer and the reaction state of the reaction solution, an allowable range used for determining whether or not the measurement result of the calibration is abnormal 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 permissible range based on the accumulated data which is the accumulated data of the measurement result of the calibration. That is, the control unit 17 functions as a calculation unit that calculates an allowable range used for determining whether or not the calibration measurement result is abnormal based on the accumulated data. Since the permissible range calculated based on the accumulated data is appropriately narrowed, the reliability of the measurement result of the calibration is improved.

With reference to FIG. 2, an example of the processing flow of this embodiment, that is, the flow of calculation / 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. The calibration is executed by a request from the operator or a recommendation request from the automatic analyzer.

An example of a screen for requesting calibration and a screen for an operator to select whether or not to accumulate 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. In addition, the rows of the table on the screen correspond to the measurement items of calibration.

In the evaluation mode area 30, a check box for selecting whether or not to accumulate the measurement result of the calibration is displayed. That is, the measurement results of the rows with the check boxes checked are accumulated.

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

The operator selects in the evaluation mode area 30 which calibration measurement result is to be accumulated based on the result of confirming the display contents of the position area 31, the item area 32, the factor area 33, and the 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 executed according to the request. The analysis unit 1 performs multiple measurements in which the same measurement is performed a plurality of times for the requested calibration.

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

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

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

(S205)
The control unit 17 calculates an 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 the index of the accumulated data A _(i) and ranges from 1 to N, and N is the number of the accumulated data of the target. Various conditions may be set when calculating the permissible 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 control width area 53. The period management area 51, the reagent lot management area 52, and the control 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 in a period is selected from a pull-down menu including "manage" and "not manage". When managing by period, the period is further specified. By designating the period of the accumulated data A _(i) , the permissible range can be calculated separately according to, for example, before and after the maintenance of the automatic analyzer, the frequency of use of the automatic analyzer, and the like. .. By dividing before and after the maintenance, even if the state of the automatic analyzer changes due to the maintenance, the permissible range can be set for the accumulated data after the maintenance.

In the reagent lot management area 52, _{whether or not to manage the accumulated data A (i)} read from the storage unit 14 in the reagent lot is selected from a pull-down menu including "manage" and "not manage". When the accumulated data A _(i) is managed by the 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. In the screen illustrated in FIG. 5, "1SD", "2SD", and "3SD" are included as management width options. Check items include the absorbance range of the first standard solution, the allowable absorbance for variation, the allowable absorbance for sensitivity, and the allowable absorbance for convergence.

The first standard solution absorbance range is the allowable range of the 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, the color tone of the reagent is reflected in the absorbance of the first standard solution, so that the deterioration of the reagent can be confirmed by the absorbance of the first standard solution. The permissible absorbance for variation is the upper limit of the difference between a plurality of absorbances obtained by multiple measurements of a standard solution. The permissible sensitivity 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. Convergence allowable absorptiometry is an approximation formula and measurement of a calibration curve in a non-linear calibration curve, which is a calibration curve of a curved line or a broken line, or a multipoint linear calibration curve, which is a calibration curve that linearly approximates a combination of three or more absorbances and concentrations. It is the upper limit of the standard deviation of the difference from the measured absorbance.

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 control 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 specified is determined based on, for example, the selection in the period management area 51 on the screen shown in FIG. That is, in the period management area 51, if "manage" is selected and the period is specified, 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, and if not, the process proceeds to S404.

(S403)
The control unit 17 uses the accumulated data A _(i) for 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.

The processes S402 to S404 are not essential and may be omitted. By omitting the processes of S402 to S404, the operation by the operator is reduced.

(S405)
The control unit 17 _{determines whether or not the accumulated data A (i)} is managed by the reagent lot. Whether or not to manage with the reagent lot is determined based on the 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 manages, and if "not manage" is selected, it is determined that the reagent lot does not manage. When managing with a reagent lot, the process proceeds to S406, and when not, the process proceeds to S407.

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

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

The processing of S405 to S407 is not essential and may be omitted. By omitting the processes of S405 to S407, the operation by the operator is reduced.

(S408)
The control unit 17 calculates the average value A _{average of the accumulated data A (i) of the target.} Average value A _{For calculating the average} , for example, the following equation is used.

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

(S410)
The control unit 17 calculates an allowable range within a control width specified for each check item. The permissible range is, for example, a range determined by the upper limit value or the lower limit value calculated by the following equation.

Note that n is a natural number, for example, 1, 2, and 3. The value of n is set based on the selection in the control width area 53 of the screen shown in FIG. 5, for example. 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 the management width of the allowable range in the management width area 53 of the screen illustrated in FIG. 5, the allowable range is calculated according to the management width of each medical facility. If the conditions on the screen illustrated in FIG. 5 are not set, a predetermined value, for example, 2 may be set for n.

Returning to the description of FIG.

(S206)
The control unit 17 sets an allowable range presented by the reagent manufacturer. The allowable range presented by the reagent manufacturer is downloaded from the reagent manufacturer'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 permissible range calculated in S205 or the permissible range set in S206.

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

In the reagent lot display area 60, the lot number of the reagent is displayed. In the permissible range display area 61, the permissible range calculated in S205 or the permissible range set in S206 is displayed for each check item. On the screen illustrated in FIG. 6, the first standard solution absorbance range, the permissible dispersion absorbance, the permissible sensitivity absorbance, and the permissible convergence absorbance are displayed as check items, and the permissible range of each check item is displayed for each reagent lot. If the calibration measurement result is out of the permissible range displayed in this step, a warning is displayed on the display unit 15. The reset button 62 is a button for resetting the allowable range displayed in the allowable range display area 61. The 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 pressed consecutively, the permissible range and the accumulated data calculated in S205 are deleted.

According to the processing flow described above, the permissible range used for determining whether or not 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 permissible range can be set based on the specified control width, it is only necessary to determine the control width at each medical facility, and it is not necessary for each operator to bother. Furthermore, since the permissible range is calculated based on the accumulated data for the specified period, even if the state of the automatic analyzer changes due to maintenance, etc., the permissible range suitable for the automatic analyzer after the state changes. Can be set.

The examples of the present invention have been described above. The present invention is not limited to the above-described embodiment, and the components may be modified without departing from the gist of the invention. Moreover, you may combine a plurality of components disclosed in the said Example as appropriate. Further, some components may be deleted from all the components shown in the above embodiment.

1: Analytical unit 2: Specimen container 3: Specimen rack 4: Transport line 5: Specimen probe, 6: Reagent probe, 7: Reagent container, 8: Reagent disc, 9: Reaction vessel, 10: Reaction disc, 11: Stirring unit, 12: Photometric meter, 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 width area, 54: Update button, 60: Reagent Lot display area, 61: Allowable range display area, 62: Reset button, 63: Registration button

Claims (8)

An automatic analyzer that analyzes samples
An analysis unit that analyzes the sample after making measurements for calibration,
A storage unit that stores accumulated data, which is the accumulated data of the measurement results of the calibration, and a storage unit.
A calculation unit that calculates the permissible range used to determine whether or not the calibration measurement result is abnormal based on the accumulated data, and
An automatic analyzer comprising a display unit for displaying the permissible range. The automatic analyzer according to claim 1.
The calculation unit is an automatic analyzer characterized in that the allowable range is calculated using a control width specified in advance. The automatic analyzer according to claim 2.
An automatic analyzer characterized in that the control width is set using the standard deviation of the accumulated data. The automatic analyzer according to claim 3.
The automatic analyzer is characterized in that the permissible range is a range from a value obtained by subtracting the control width from the average value of the accumulated data to a value obtained by adding the control width to the average value. The automatic analyzer according to claim 1.
The storage unit is an automatic analyzer characterized in that data selected from the measurement results of the calibration is stored as the accumulated data. The automatic analyzer according to claim 1.
The calculation unit is an automatic analyzer characterized in that the allowable range is calculated using accumulated data included in a predetermined period. The automatic analyzer according to claim 1.
The calculation unit is an automatic analyzer characterized in that the allowable range is calculated using accumulated data for each lot of reagents used for the calibration. The automatic analyzer according to claim 1.
An automatic analyzer characterized in that a screen for setting a period, a lot of reagents, and a control width for each measurement item of the calibration is displayed on the display unit.

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