Patent Application
20230135949
The present invention relates to an automatic analysis device that analyzes a sample.
An automatic analysis device is used to measure a concentration of a specific component contained in a sample such as blood or urine. More specifically, the automatic analysis device measures absorbance of a reaction solution obtained by the sample reacting with a reagent, potential of an electrolyte solution obtained by diluting the sample, and the like, and measurement results of the absorbance, the potential, and the like are converted into the concentration of the specific component using a calibration curve created in advance. The calibration curve is created by executing calibration including measurement of the absorbance, the potential, and the like using a plurality of standard solutions having known concentrations or a calibration solution. Further, in order to execute quality control on the automatic analysis device, it is periodically confirmed that a measurement value of a quality control substance having a known concentration is within a range of quality control. It is desirable that the calibration is executed with an appropriate implementation content and at an appropriate interval according to results of the quality control or the like.
PTL 1 discloses an automatic analysis device that notifies an implementation content and a period of calibration based on a result of comparing a variation pattern stored for a combination of results of quality control and calibration with a measured variation pattern.
PTL 1: JP-A-2012-026815
However, PTL 1 does not disclose supporting an analysis of a cause of variation occurring in a measurement value of a quality control substance. When the measurement value of the quality control substance varies, it is desirable to quickly analyze the cause of variation. For example, when it is possible to estimate whether the cause of variation in the measurement value of the quality control substance is a lot change of a calibration solution used for calibration, a subsequent measure is easy to be taken.
Therefore, an object of the invention is to provide an automatic analysis device that estimates a cause of variation in a measurement value of a quality control substance.
In order to achieve the above object, the invention provides an automatic analysis device for analyzing a sample. The automatic analysis device includes: an acquisition unit configured to acquire a variation amount of a measurement value of a quality control substance used for quality control; a calculation unit configured to calculate a predicted variation amount based on a difference value between concentration values of a calibration solution used for calibration before and after a lot change; and an estimation unit configured to estimate a cause of variation occurring in the measurement value of the quality control substance based on a comparison result between the variation amount and the predicted variation amount.
According to the invention, it is possible to provide an automatic analysis device that estimates a cause of variation in a measurement value of a quality control substance.
Hereinafter, preferred embodiments of an automatic analysis device according to the invention will be described with reference to the accompanying drawings. In the following description and the accompanying drawings, components that have the same function and configuration are denoted by the same reference numerals, and repeated descriptions thereof are omitted. The drawings schematically represent the embodiments, and a real object may be shown in a simplified manner.
An example of a configuration of an automatic analysis device 1 will be described with reference to
On the sample disk 2, sample cups 3 each containing a sample such as blood or urine supplied from a patient or a standard sample used for calibration and quality control are concentrically arranged and loaded. The sample cups 3 may not be loaded on the sample disk 2 but on a sample rack in which the sample cups 3 are arranged on a straight line.
The standard sample used for calibration includes a standard solution having a known concentration of a specific component and a calibration solution. The standard solution is a solution containing the specific component, and has at least a concentration in the vicinity of an upper limit value and a concentration in the vicinity of a lower limit value of a measurement range of the automatic analysis device 1. That is, at least two standard solutions are used. The calibration solution is a solution that simulates a sample supplied from the patient.
Reagents to be reacted with a sample or the like are stored on the reagent disk 4. Each reagent is dispensed into the reaction container 5 from the reagent disk 4 by the reagent dispensing unit 6. Further, the sample or the like is dispensed into the reaction container 5 from a sample cup 3 by the sample dispensing unit 7. The reagent, the sample, and the like that are dispensed into the reaction container 5 react and develop a color by being maintained at a predetermined temperature, and absorbance of a color-developed liquid is measured by the photometer 13. The reagent disk 4, the reaction container 5, the photometer 13, and the like related to absorbance measurement are collectively referred to as colorimetric units.
The electrolyte measurement unit 8 is a unit that measures potential of an electrolyte solution obtained by diluting the sample or the standard sample, and will be described later with reference to
The computer 10 controls units connected through the interface 9, calculates a concentration value of the specific component based on results measured by the colorimetric units or the electrolyte measurement unit 8, and outputs the calculated concentration value to the output unit 12. The output unit 12 is, for example, a liquid crystal monitor, a touch panel, or a printer, and displays and prints the concentration value of the specific component output from the computer 10. Measurement conditions and the like in the colorimetric units or the electrolyte measurement unit 8 may be received from the input unit 11. The input unit 11 is, for example, a keyboard or a mouse, and when the output unit 12 is a touch panel, a graphical user interface (GUI) displayed on the touch panel functions as the input unit 11.
An example of a configuration of the electrolyte measurement unit 8 will be described with reference to
In the dilution tank 18, the sample or the standard sample dispensed from the sample cup 3 by the sample dispensing unit 7 is diluted by the diluent 17 to a concentration suitable for measurement. The diluted sample or the diluted standard sample is passed through the Cl electrode 19, the K electrode 20, and the Na electrode 21 by operations of the pinch valve 22. Potential corresponding to ion concentrations of Cl ions, K ions, and Na ions contained in the passing-through solution is generated in the Cl electrode 19, the K electrode 20, and the Na electrode 21, respectively. In addition, since potential corresponding to a concentration of a reference electrode solution 24 is also generated in the reference electrode 23, a potential difference between each of the Cl electrode 19, the K electrode 20, and the Na electrode 21 and the reference electrode 23 is measured by the potentiometer 15. Prior to measurement of a potential difference of the diluted sample or the diluted standard sample, a potential difference of an internal standard solution 16 with respect to the reference electrode solution 24 is measured as a reference potential of the electrolyte measurement unit 8. The potential difference measured by the potentiometer 15 is sent to the electrolyte concentration calculation unit 14.
The electrolyte concentration calculation unit 14 is a calculation unit that converts the potential difference measured for the sample into the ion concentrations of the Cl ions, the K ions, and the Na ions contained in the sample, and includes, for example, a central processing unit (CPU) and a memory. The computer 10 may function as the electrolyte concentration calculation unit 14. In order to convert the measured potential difference into the concentration of the specific component, a calibration curve, which is a straight line representing a relationship between the potential difference and the concentration, is used. The calibration curve is created by executing calibration including measurement of a potential difference of a plurality of standard solutions having known concentrations or a calibration solution.
Specifically, an inclination of the calibration curve is calculated by setting a potential difference measured for a standard solution having a low concentration and a potential difference measured for a standard solution having a high concentration on a vertical axis and setting concentrations of the two standard solutions on a horizontal axis. Further, a segment of the calibration curve having the calculated inclination is calculated based on the potential difference measured for the calibration solution and a concentration of the calibration solution. The calibration curve created by calibration is stored in the electrolyte concentration calculation unit 14, and is read and used when a concentration of the sample or a quality control substance is calculated.
The quality control will be described with reference to
A variation of the measurement value of the quality control substance will be described with reference to
Therefore, in the present embodiment, the cause of variation in the measurement value of the quality control substance is estimated based on a comparison result between a predicted variation amount, which is calculated based on a difference value between the concentration values of the calibration solution used for calibration before and after the lot change, and a variation amount of the measurement value of the quality control substance.
An example of a flow of processing according to the present embodiment will be described for each step with reference to
The computer 10 causes the colorimetric units or the electrolyte measurement unit 8 to measure the standard solution and the calibration solution, and executes calibration. Specifically, the inclination of the calibration curve is calculated based on measurement values of absorbance or potential differences of the standard solutions having a low concentration and a high concentration and the concentrations of the two standard solutions. Further, a segment of the calibration curve having the calculated inclination is calculated based on measurement values of absorbance or a potential difference of the calibration solution and the display value of the concentration of the calibration solution.
When the lot of the calibration solution is changed, a calibration curve is created based on a display value CN of a concentration of a new lot calibration solution, which is the calibration solution after the lot change, and a measurement value for the new lot calibration solution, and the calibration curve is stored together with the lot change of the calibration solution. In addition to the created calibration curve, a display value Co of a concentration of an old lot calibration solution, which is the calibration solution before the lot change, is stored together with the display value CN of the new lot calibration solution. Further, the measurement values of the absorbance or the potential differences for the old lot calibration solution and the new lot calibration solution are also stored. When the lot of the calibration solution is not changed, the calibration curve is created and stored based on the display value Co of the old lot calibration solution and the measurement value for the old lot calibration solution.
The computer 10 causes the colorimetric units or the electrolyte measurement unit 8 to measure concentration values of at least two quality control substances. Specifically, a measurement value of absorbance or a potential difference of each quality control substance is converted into a concentration value of the quality control substance by the calibration curve calculated in S501. The calculated concentration value may be displayed in the daily difference variation graph.
The computer 10 determines whether a variation is present in the concentration values of the quality control substances measured in S502. Presence or absence of the variation is determined based on, for example, a comparison between an average value of past measurement values ± 2 . standard deviation and the measurement value in S502. Since a measurement value of 120.9 of 2020/1/14 in
The computer 10 estimates the cause of variation in the measurement value of the concentration of the quality control substance.
An example of a flow of processing in the present step will be described with reference to
The computer 10 determines whether the lot of the calibration solution is changed. When the lot is changed, the process proceeds to S602, and when the lot is not changed, the process proceeds to S608.
The computer 10 determines whether the measurement value of each quality control substance satisfies a predetermined condition. The predetermined condition is, for example, a condition in which the number of times of measurement for the measurement value of each quality control substance is equal to or greater than a predetermined number of times, a coefficient of variance (CV) of the measurement value of each quality control substance is equal to or less than a set value, and a variation of the measurement value of each quality control substance is within the set value with respect to a display value. The predetermined number of times is, for example, three times, the set value of the coefficient of variance CV is, for example, 3%, and the set value with respect to the display value is, for example, 3%. When the predetermined condition is satisfied, the process proceeds to S603, and when the predetermined condition is not satisfied, the process proceeds to S608.
The computer 10 calculates an old lot concentration value and a new lot concentration value of the calibration solution as unknown samples. Specifically, measurement values of absorbance or potential differences for the old lot calibration solution and the new lot calibration solution that are stored in S501 are converted into a concentration value C′o of the old lot calibration solution and a concentration value C′N of the new lot calibration solution by the calibration curve created in S501.
The computer 10 determines whether the measurement value of each quality control substance and the concentration value of the calibration solution have the same variation direction among lots. Specifically, it is determined whether positive or negative of the variation amount acquired in S503 is the same as that of a difference value (C′N - C′o) between the concentration values C′o and C′N calculated in S603. When the variation directions are the same, the process proceeds to S605, and when the variation directions are different, the process proceeds to S608.
The computer 10 calculates the predicted variation amount of the concentration value of the quality control substance generated due to the lot change of the calibration solution. That is, the computer 10 functions as a calculation unit that calculates the predicted variation amount. The predicted variation amount is calculated based on a difference value (CN - Co) between an old lot display value Co and a new lot display value CN of the calibration solution and the difference value (C′N - C′o) between the concentration values C′o and C′N calculated in S603. More specifically, a ± set value of a difference { (C′N - C′o) -(CN - Co) } between the difference value (C′N - C′o) and the difference value (CN - Co) is calculated as the predicted variation amount. For example, 50% is used as the set value.
The computer 10 determines whether the variation of the measurement value of each quality control substance is within the predicted variation amount. When the variation is within the predicted variation amount, the process proceeds to S607, and when the variation is not within the predicted variation amount, the process proceeds to S608.
The computer 10 estimates that the cause of variation in the measurement value of the quality control substance is the lot change of the calibration solution. The estimated cause of variation may be displayed in a daily difference variation graph as shown in
The computer 10 estimates that the cause of variation in the measurement value of the quality control substance is not the lot change of the calibration solution. The estimated cause of variation may be displayed as a comment in the daily difference variation graph. Instead of displaying the comment of the cause of variation, the difference value (C′N - C′o) between the measurement values of the concentrations of the calibration solution before and after the lot change may be displayed as a reference.
According to the flow of processing described above, the cause of variation in the measurement value of the concentration of the quality control substance is estimated. That is, the computer 10 functions as an estimation unit that estimates the cause of variation occurring in the measurement value of the quality control substance. The operator may take a measure according to the estimated cause of variation.
The description returns to
The computer 10 determines whether the concentration value of the quality control substance is within the range of quality control. When the measurement value is within the range of quality control, the process proceeds to S506, and when the measurement value is not within the range, the process returns to S501.
The computer 10 causes the colorimetric units or the electrolyte measurement unit 8 to measure the sample supplied from the patient. A measurement result is output to the output unit 12.
According to the flow of processing described above, when the measurement value of the quality control substance varies, the cause of variation is estimated. Since the operator can take an appropriate measure according to the cause of variation estimated by the automatic analysis device 1, subsequent sample measurement is smoothly executed, and quality of the sample measurement is also maintained.
In the first embodiment, estimation of the cause of variation in the measurement value of the quality control substance is described. It is preferable that the operator takes a measure according to the estimated cause of variation. For example, the concentration value of the calibration solution input through the input unit 11 may be changed within a range of display values provided by the reagent manufacturer. In the present embodiment, presentation of a more appropriate input value will be described.
In many cases, the display value of the calibration solution provided by the reagent manufacturer is in a range of values that can be input, and is denoted by, for example, “140 ± 1” as the display value of Na. Therefore, in the present embodiment, when the process proceeds to S607 in
A plurality of input values may be output, and as shown in
In the first embodiment, estimation of the cause of variation in the measurement value of the quality control substance is described. When the cause of variation is clear, the measurement value of the quality control substance may be corrected according to the cause of variation. Therefore, in the present embodiment, when the process proceeds to S607 in
A plurality of embodiments of the invention are described above. The invention is not limited to the embodiments described above, and the components may be modified without departing from the scope of the invention. A plurality of components disclosed in the above embodiments may be appropriately combined. Further, several components may be omitted from all the components shown in the above embodiments.
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| Number | Date | Country | Kind |
|---|---|---|---|
| 2020-048865 | Mar 2020 | JP | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/JP2021/001436 | 1/18/2021 | WO |
