WO2024204825A1

WO2024204825A1 - Analysis method for automated analysis device, and automated analysis device

Info

Publication number: WO2024204825A1
Application number: PCT/JP2024/013337
Authority: WO
Inventors: 清一郎石岡
Original assignee: 積水メディカル株式会社
Priority date: 2023-03-30
Filing date: 2024-03-29
Publication date: 2024-10-03

Abstract

Provided are an analysis method for an automated analysis device, and the automated analysis device, with which it is possible to construct a highly accurate calibration curve that can be used over a wide range up to a high concentration region, using a small number of calibration points.　An analysis method for an automated analysis device according to the present invention uses a calibration curve created by calibration performed using a calibrator adjusted in advance to a known concentration, to convert a measurement result, obtained from the analysis device by reacting a reagent corresponding to an analysis item with a specimen, into a concentration value, in order to analyze a component to be measured contained in the specimen. The calibration curve is created using two or more calibrator measurement values C0, C1 located in a linear region S and one or more unique calibrator measurement values CP located in a convergence region P, and a concentration value. In this case, the unique calibrator measurement value Cp located in the convergence region P is one that is held in advance by the analysis device.

Description

Analysis method for automatic analyzer and automatic analyzer

The present invention relates to an automatic analyzer and an analytical method that can obtain measurement information for various test items by reacting test objects such as blood, urine, and other specimens and standard samples (calibrators) with various reagents and measuring the reaction process, reaction progress, reaction results, etc., and in particular to an automatic analyzer and an analytical method that can contribute to improving the accuracy of measurements using electrochemiluminescence.

Automatic analyzers, such as blood coagulation analyzers and analyzers using immunoassays, are known in various forms that can obtain measurement information for various test items by reacting the test object (specimen) containing the components to be measured, such as blood or urine, with various reagents and measuring the reaction process and reaction results. For example, such automatic analyzers dispense the test object (specimen) from a specimen container into a reaction container, and then dispense and mix the dispensed specimen with a reagent according to the test item to perform various measurements and analyses. Specifically, for example, an automatic analyzer for clinical testing dispenses a fixed amount of the test object and reagent to react with each other, and then measures the amount of luminescence or absorbance of this reaction liquid within or after a fixed time, and obtains test values such as the concentration and activity value of the substance to be measured based on the measurement results (photometric results).

　Measurement by electrochemiluminescence is known as a method for measuring the amount of luminescence from a reaction solution (containing the object to be measured). In this method, a reagent containing a labeling substance is reacted with the object to be tested, a complex containing the object to be measured and the labeling substance is captured, and electrochemiluminescence of the labeling substance is generated, and the number of photons is measured with a photometer to qualitatively or quantitatively measure the object to be measured (the component to be measured).

In order to perform such qualitative or quantitative analysis, it is necessary to analyze standard solution samples (hereinafter referred to as "calibrators") that have been adjusted to multiple known concentrations in advance for each reagent bottle set using the corresponding reagent, and to obtain a relationship equation between concentration and absorbance or a relationship equation between concentration and luminescence (hereinafter referred to as a "calibration curve") (see, for example, Patent Document 1). Then, the photometric results are converted into concentration values by using the calibration curve created by such calibration analysis performed for each analysis item. In this way, the calibration curve for converting the measurement value (photometric value) of the photometric device into the concentration of the substance to be measured is adjusted to output the correct concentration value, reflecting the state of the device and reagent at the time of measurement, and this calibration curve data is generally stored for each reagent bottle set (or each lot of reagent bottles).

JP 2022-034183 A

In the calibration of the automatic analyzer described above, a calibrator (standard liquid sample) with a known concentration is used to measure a specified calibration point before measuring the actual test object, and the photometric value of the measured calibrator is used to change (calibrate) the calibration curve of the measuring device. The problems with this type of calibration in the conventional technology are explained using Figures 4 and 5.

Figure 4 shows the calibration curve for a reagent system that is expected to change in a way that has a linear region S where the measurement value (count, which is a photometric value) increases with increasing concentration (amount of incident light), and a convergence region (plateau region) P where the measurement value does not change even with increasing concentration. In Figure 4, the solid line shows the calibration curve using a high-sensitivity reagent, and the two-dot chain line shows the calibration curve using a low-sensitivity reagent. Note that the measurement value in the convergence region is a unique value that depends on the capabilities of the measuring device used, so the measurement value in the convergence region P will be the same whether a high-sensitivity reagent or a low-sensitivity reagent is used.

Figure 5 shows an example of a case where a master calibration curve L1, which serves as the calibration standard, is calibrated using a conventional calibration method that uses only two calibrator measurement values on the linear range S of the calibration curve as calibration points. Here, the two calibration points on the linear range S are two measurement positions on the linear range S that have predetermined concentrations (calibrator concentrations) selected to reflect the characteristics of the change in the calibration curve. In Figure 5, the calibration curve L1 before correction and the calibration curve L2 after correction are shown with thick solid lines.

In this way, in the conventional method of performing calibration using only two calibration points on the linear range S, as is clear from FIG. 5, the following problems arise.
That is, when the calibration of the low-sensitivity reagent is performed using only the two calibration points C0 (origin) and C1 on the linear range S, the calibration curve L1 before correction (the reference calibration curve: the master calibration curve) is changed (calibrated) to the calibration curve L2 after calibration uniformly in the entire concentration range shown in Fig. 5 in accordance with the rate of decrease in the calibrator measurement value (the calibration curve is uniformly corrected). Therefore, the value of the convergence range P of the calibration curve also decreases according to the rate of decrease in the calibrator measurement value.

However, as mentioned above, the photometric value (count) in the convergence region P is a device-specific value determined by the measurement capabilities (individual differences) of the measuring device, and the measurement value (count) in the convergence region in the high concentration region should not change even if the reagent deteriorates and becomes a low-sensitivity reagent. Despite this, in the calibration curve L1 after conventional calibration, the measurement value (upper limit) of the convergence region P, which is a plateau portion that should not actually change, changes and shifts as the convergence region P is approached. If a calibration curve L2 calibrated in this way is used, a concentration value that is different from the actual one will be calculated in the high concentration region, and it will be converted into a concentration value with a large error. Therefore, calibration using conventional methods can only construct a narrow range calibration curve that can be used only in the linear region S.

For this reason, it may be possible to increase the number of calibration points to reflect the characteristics of the changes in the calibration curve, but increasing the number of calibration points would also increase the running costs of the reagents involved in the calibration. Considering the current situation of automated analyzers, which require reduction in reagent costs for calibration and simplification of measurement operations, there is an urgent need for a new method that enables the construction of a highly accurate calibration curve that can be used over a wide range, up to high concentration ranges, with a small number of calibration points, especially when the relationship between the incident light amount (concentration) and the count value (calibration curve) has a linear region and a convergence region.

The present invention was made with a focus on the above-mentioned problems, and aims to provide an automatic analysis method and automatic analysis device that can construct a highly accurate calibration curve that can be used over a wide range, up to high concentration ranges, with a small number of calibration points.

In order to achieve the above-mentioned object, an analysis method for an automatic analyzer according to one aspect of the present invention is an automatic analysis method that converts measurement results obtained from the automatic analyzer into concentration values by reacting a sample with a reagent corresponding to the analysis item using a calibration curve calibrated by calibration using a calibrator adjusted to a known concentration in advance, and analyzes the components to be measured contained in the sample, the calibration curve having a linear region in which the measured value increases with increasing concentration and a convergence region in which the measured value does not change even if the concentration increases, the calibration of the calibration curve by the calibration is performed using two or more calibrator measurement values located in the linear region and one or more unique calibrator measurement values located in the convergence region, and at least one of the unique calibrator measurement values located in the convergence region used in the calibration is a value unique to each automatic analyzer, and is read and used from a value stored in advance within each automatic analyzer or in a location other than each automatic analyzer.

　According to the analysis method of the automatic analyzer having the above configuration, the calibration curve is created using two or more calibrator measurement values located in the linear region, as well as one or more unique calibrator measurement values (maximum output value specific to the device) located in the convergence region, which is a device-specific value that is determined in advance by the individual differences of the photometric system of the measurement unit of the automatic analyzer. In this way, in addition to two or more calibrator measurement values in the linear region, the maximum output value specific to the automatic analyzer is also used, as well as the unique calibrator measurement value corresponding to the concentration value in the convergence region, so that the movement of the convergence region P (L1 → L2) as shown in Figure 5 described above does not occur during calibration. Therefore, it is possible to construct a highly accurate calibration curve that can be used in a wide range up to the high concentration region. Two unique calibrator measurement values can be used. In addition, at least one of the unique calibrator measurement values can be the maximum saturation light value measured by each automatic analyzer, or can be within the range of 95% to 100% of the maximum saturation light value measured by each automatic analyzer.

At least one device-specific calibrator measurement value located in the convergence region is measured in advance before delivery of the device and stored in advance in the analytical device itself or in a memory unit external to the device in a state where it can be accessed when needed. Therefore, there is no need to acquire a specific calibrator measurement value located in the convergence region during calibration. Therefore, only the calibrator measurement value in the linear region needs to be acquired during calibration, and a highly accurate calibration curve that can be used over a wide range up to the high concentration region can be constructed with a small number of calibration points. As a result, it is possible to reduce the reagent costs required for calibration and simplify the measurement operation.

An automatic analyzer according to one aspect of the present invention is an automatic analyzer that converts a measurement result obtained by reacting a reagent corresponding to an analysis item with a specimen into a concentration value using a calibration curve calibrated by calibration using a calibrator previously adjusted to a known concentration, and analyzes a component to be measured contained in the specimen, the automatic analyzer comprising: an introduction unit that receives the specimen and the reagent containing a labeling substance; a measurement unit that measures the amount of light obtained from the labeling substance and measures the component to be measured contained in the specimen qualitatively or quantitatively using the calibrated calibration curve based on the measured value; and a calibration curve calibration unit that calibrates the calibration curve by calibration in cooperation with the measurement unit;
The calibration curve has a linear region where the measured value increases with increasing concentration and a convergence region where the measured value does not change even if the concentration increases, and the calibration curve calibration unit creates the calibration curve using two or more calibrator measurement values located in the linear region and one or more specific calibrator measurement values located in the convergence region specific to the automatic analyzer and stored in advance inside the automatic analyzer or outside the automatic analyzer. Here, the specific calibrator measurement values can be maximum saturation light intensity values measured by each automatic analyzer. Alternatively, they can be within a range of 95% to 100% of the maximum saturation light intensity values measured by each automatic analyzer.

　According to the automatic analysis method and automatic analyzer of the present invention, by storing specific calibrator measurement values in a convergence range specific to each automatic analyzer, either internally or externally, and using these to perform calibration, it is possible to construct a highly accurate calibration curve that can be used over a wide range, even up to high concentration ranges, with a small number of calibration points. Therefore, highly accurate measurements and analysis according to each automatic analyzer are possible.

1 is a schematic diagram of a main configuration of an automatic analyzer according to one embodiment of the present invention. FIG. 13 is a diagram showing a calibration curve having a linear region and a convergence region according to the present embodiment, which is created using two or more calibrator measurement values located in a linear region and one or more calibrator measurement values and concentration values located in a convergence region (the solid line shows the calibration curve using a high-sensitivity reagent, and the two-dot dashed line shows the calibration curve using a low-sensitivity reagent). FIG. 11 is a schematic diagram showing an example of how a calibration curve is constructed when multiple calibrator measurements are used in a convergence region. FIG. 1 shows calibration curves having a linear range and a convergence range, which were prepared using a high-sensitivity reagent and a low-sensitivity reagent, respectively. FIG. 1 shows a calibration curve created by a conventional method in which calibration is performed using only two calibration points in the linear range. 2 is a functional block diagram showing an example of a control unit of the automatic analyzer 1 and a configuration for performing calibration. FIG.

Hereinafter, an embodiment of the present invention will be described with reference to the drawings.
The automatic analyzer 1 of the present embodiment shown in Fig. 1 is not shown in its entirety, but includes a reaction unit that holds a reaction vessel into which a specimen such as blood or urine collected from a person is dispensed, and a reagent supply unit that supplies the reagent in the reagent vessel to the reaction vessel. The automatic analyzer 1 obtains measurement information for a predetermined test item by reacting the reagent supplied from the reagent supply unit to the reaction vessel with the specimen and measuring the reaction process (measuring the reaction liquid obtained by mixing the reagent and the specimen). Specifically, the automatic analyzer 1 of the present embodiment measures, as an example, the amount of luminescence of the measurement object obtained from the reaction liquid after a certain time, and obtains test values such as the concentration and activity value of the measurement object based on the photometric result.

The electrochemiluminescence method is used to measure the amount of luminescence of the object to be measured. In this method, a reaction liquid (hence a liquid containing a complex containing the labeling substance, the object to be measured, and the solid phase carrier) in which a reagent containing a magnetic solid phase carrier (magnetic particles in this embodiment) and a reagent containing a specimen and a labeling substance are mixed is poured into the flow path of the flow cell constituting the measurement section. The complex is then captured in a part of the flow path by a magnetic field. In this case, the magnetic field is generated by contacting a magnet with the outer wall of the flow path at the electrode section consisting of a working electrode and a counter electrode facing each other across the flow path of the flow cell. Then, the magnetic particles that have captured the object to be measured are captured and remain on the electrode section due to the magnetic attraction force of this magnet. Then, after removing the magnetic field, for example by removing the magnet in this captured state, a voltage is applied to the electrode section to generate electrochemiluminescence of the labeling substance (the labeling substance that forms a complex with the magnetic particles and the object to be measured emits light), and the number of photons is measured to qualitatively or quantitatively measure the object to be measured (the component to be measured).

Next, the configuration of the automated analyzer 1 of this embodiment, which can perform measurements using such electrochemiluminescence, will be briefly described with reference to FIG. 1.

As shown in FIG. 1, the automatic analyzer 1 according to this embodiment includes a heating unit 50 for heating the liquid required for measurement to a desired temperature using a heater 24, an introduction nozzle (an introduction unit that receives a reagent containing the test object and a labeling substance) 99 as an introduction tube for injecting the above-mentioned reaction liquid into the liquid required for measurement heated by the heating unit 50 to produce a liquid containing the object to be measured, and a measurement unit 60 for magnetically capturing a complex formed by the object to be measured and the labeling substance bound to magnetic particles from the liquid containing the object to be measured using an electrode unit 70 and measuring the complex using an electrochemiluminescence method. The measurement unit 60 constitutes a flow cell and is kept at a constant temperature by a heater (not shown), and obtains measurement information related to a specified analysis item of the object to be measured.

Here, "liquid containing the object to be measured" refers to any physical form that should be supplied to the measurement unit 60 in a state required to measure the specimen for a specified analysis item, such as a mixture (reaction liquid) of a biological sample (specimen) and a reagent (calibration liquid). Also, "object to be measured" refers to the substance to be measured by the measurement unit 60, and refers to the specimen itself or a substance contained in the specimen, or a component to be measured that is contained in the test object.

"Test subject (specimen or calibrator)" refers to a liquid containing the component to be measured, and refers to a biological sample (specimen) such as blood or urine, or a liquid (calibrator) adjusted to show a known concentration or brightness, such as a control reagent or calibration reagent. In this embodiment, the liquids required for measurement (not including the specimen) are a cleaning liquid (CC liquid) that cleans the introduction nozzle 99 and washes away substances not required for measurement and substances after measurement, and a luminescent electrolyte (EB liquid) used in measurement by electrochemiluminescence method, and therefore the automatic analyzer 1 of this embodiment has a liquid supply unit 20 for supplying CC liquid and a liquid supply unit 22 for supplying EB liquid.

In this embodiment, the heating unit 50 is made up of a temperature control block equipped with a coiled tube 35 through which the liquid required for the measurement flows, and the liquid required for the measurement in the coiled tube 35 is heated by heating the coiled tube 35 with a heater 24. In addition, the liquid supply units 20 and 22 are connected to the coiled tube 35 of the heating unit 50 via the supply flow paths 26 and 27.

A connecting trough 34 with a four-way solenoid valve 33 is interposed between the heating section 50 and the introduction nozzle 99. In this case, the four-way solenoid valve 33 has a first port 33a connected to an air intake pipe (not shown) that communicates with the outside air, a second port 33b connected to a communication pipe 31 that communicates with the liquid supply section 20 for the CC liquid via a serpentine 35, and a third port 33c connected to a communication pipe 32 that communicates with the liquid supply section 22 for the EB liquid via a serpentine 35.

The introduction nozzle 99 is joined to the combination trough 34 except when it is moved to the installation location of the reaction liquid containing the measurement target to aspirate the reaction liquid. By joining (connecting) the introduction nozzle 99 to the combination trough 34, a flow path is formed that flows the liquid necessary for measurement from the heating unit 50 and the reaction liquid (liquid containing the measurement target) introduced by the introduction nozzle 99 into the flow path 60a of the measurement unit 60 via the connection flow path 40. Then, after the introduction nozzle 99, which has aspirated the reaction liquid (and therefore the measurement target), is joined to the combination trough 34, the "liquid necessary for measurement" moves inside the introduction nozzle 99 and mixes with the reaction liquid to become the "liquid containing the measurement target."

In this embodiment, the measurement unit 60 constituting the flow cell is constructed by protecting the periphery of a metal box with a thermal insulating material, and includes a flow path 60a through which a liquid containing the object to be measured flows, an optical sensor 60b (an optical device including a light receiving element: for example, a photomultiplier tube) that measures the amount of light emitted, and an electrode unit 70 that magnetically captures a complex formed by binding the object to be measured and the labeling substance to the magnetic particles. The electrode unit 70 is composed of a working electrode 71 and a counter electrode 72 that face each other across the flow path 60a, and has a magnet 73 that generates a magnetic field when brought close to (or in contact with) the outer wall of the flow path 60a on the working electrode 71 side. The magnetic attraction force of this magnet 73 causes the magnetic particles containing the object to be measured (i.e., the complex) to be captured and remain on the working electrode 71.

Then, in this captured state, the magnetic field is removed, for example by removing the magnet 73, and a voltage is applied to the electrode section 70 to generate electrochemiluminescence of the labeled substance that forms the complex (the labeled substance that forms a complex with the magnetic particles and the object to be measured emits light), and the number of photons is counted to qualitatively or quantitatively measure the object to be measured (the component to be measured).

The measuring unit 60 is provided with a temperature sensor 75 that detects the temperature of the liquid containing the object to be measured. A pump (e.g., a peristaltic pump) 49 is inserted downstream of the flow path extending from the measuring unit 60, and is driven to supply the liquid required for measurement from the liquid supply units 20, 22 to the measuring unit 60 via the heating unit 50. At the downstream end of the flow path, a tank 74 is provided to collect the liquid containing the object to be measured after it has been measured as waste liquid.

The automated analyzer 1 of this embodiment also includes a control unit 10 that controls the operation of the introduction nozzle 99, the electrode unit 70, and the pump 49. In FIG. 1, the electrical connection lines between the control unit 10 and each unit are indicated by dashed arrows. The working and counter electrodes 71, 72 of the measurement unit 60, the temperature sensor 75, the magnet drive unit (not shown) that drives the magnet 73, and the like are also electrically connected to the control unit 10, but the connection lines have been omitted in FIG. 1 for simplification. FIG. 6 shows an example of a functional block diagram illustrating the main functions of the control unit 10. The following description will be given with reference to FIG. 1 and FIG. 6.

In the automated analyzer 1 and analysis method of this embodiment having the above configuration, calibration is performed at a predetermined timing using a calibrator (standard reagent) that has been adjusted to a known concentration in advance. Using the calibration curve, the measurement results obtained by reacting the sample with a reagent corresponding to the analysis item as described above are converted into concentration values, and the components to be measured contained in the sample are analyzed.

The calibration curve (master calibration curve) that serves as the basis for calibration is prepared in advance by the reagent manufacturer using many sample specimens (standard specimens) of different concentrations, and then supplied. For example, the master calibration curve L1 as shown in FIG. 5 may be prepared when the reagent is manufactured and stored in the automatic analyzer 1 or in an external memory unit, or the corresponding calibration curve may be supplied together with the reagent when the reagent is replaced (supplied).

Also, the unique calibrator measurement value at the calibration point of the convergence range of the automatic analyzer 1 is measured by the calibration curve calibration unit 17 in the device 1 before delivery of the automatic analyzer 1. The unique measurement data of the measured convergence range and the corresponding device-specific data such as concentration are stored, for example, in the calibration data storage unit 16b of the device 1 or in an external storage unit 116b (including USB, etc.) other than the automatic analyzer 1, together with the measured calibrator concentration and other related data. The storage location of the device-specific convergence range data is not limited to the calibration data storage unit 16b, and may be any storage unit that can be freely read out when performing calibration. Here, it is possible to perform calibration using two or more unique calibrator measurement values. In that case, the unique calibrator measurement values are stored as many as the number used for calibration. Also, at least one of the unique calibrator measurement values can be the maximum saturation light value measured by each automatic analyzer, or can be within the range of 95% to 100% of the maximum saturation light value measured by each automatic analyzer.

Calibration is performed at a specified timing when the reagent bottle set is replaced (when the product lot changes, etc.). Calibrators stored in the automatic analyzer are used to measure calibration points C0 and C1. The control unit 10 of the automatic analyzer 1 includes an input/output interface 11 for inputting and outputting data to and from each part of the automatic analyzer, a main control unit 12 that controls the entire device, an operation control unit 15 that controls the operation of the nozzle, valve, heater, and other parts, a measurement control unit 16 that controls digital measurement by the measurement unit 60, and a calibration curve calibration unit 17 that calibrates the calibration curve.

The calibration curve calibration unit 17 of the control unit 10 drives the introduction nozzle 99, the four-way nozzle 33, and the measurement unit 60 via the operation control unit 15 to introduce a mixture of the calibrator of the reagent corresponding to the calibration points C0 and C1 and the liquid required for various measurements into the measurement unit 60. After that, it waits for the reaction of the mixture and performs the measurements required for calibration under the control of the measurement control unit 16. The measurement results of these two points and the measurement values and concentrations of the convergence zone specific to the automatic analyzer stored in the calibration data storage units 16b, 116b, etc. are read out, and calibration is performed using the three calibration points.

Figure 2 shows a calibration curve calibrated using the calibration method of the present invention. In Figure 2, the solid line shows the calibration curve using a high-sensitivity reagent, and the two-dot chain line shows the calibration curve using a low-sensitivity reagent calibrated using the calibration method of the present invention.

Calibration is performed by the measurement unit 60 of the automatic analyzer 1 by itself or in cooperation with the measurement control unit (or measurement calculation circuit) of the control unit 10. As shown in FIG. 2, calibration uses calibrator measurement values (shown as calibration points C0, C1, and Cp in the figure) at two points in the linear region S of the calibration curve where the measurement value (count, which is the photometric value) increases with increasing concentration (amount of incident light) and at a convergence region P of the calibration curve where the measurement value does not change even with increasing concentration. Calibrators for calibration may be stored in the automatic analyzer beforehand, or may be set in the automatic analyzer when making measurements.

Specifically, in this embodiment, the measurement unit 60 calibrates the calibration curve using two or more calibrator measurement values (here, as an example, two calibrator measurement values (two calibration points C0 and C1)) located in the linear region S of the calibration curve and one or more calibrator measurement values (here, as an example, a calibration point Cp which is one calibrator measurement value) located in the convergence region P, and a concentration value (incident light amount). Of these, at least one unique calibrator measurement value (one unique calibrator measurement value Cp as an example) located in the convergence region P is held in advance by the automatic analyzer 1 itself (in other words, stored as a unique value by the automatic analyzer 1).

More specifically, before the automatic analyzer 1 is manufactured or installed, an ultra-high brightness standard reagent (calibrator) is measured and the unique calibrator measurement value at the calibration point Cp is stored inside or outside the automatic analyzer 1. Then, when a new reagent or a new lot of reagent is installed in the device 1, calibration is performed. In calibration, for example, the concentration value of the calibrator is measured at calibration points C0 and C1. Next, when calibrating the calibration curve, the numerical values of C0, C1, and Cp can be used to obtain the coefficients of the calibration curve by the least squares method or other means.

Generally, when the concentration of the substance to be measured becomes very high and the amount of light received by the photometric system becomes very large, the photometric system becomes saturated and the output value (count value) stops changing despite the increase in concentration. This appears on the calibration curve as the convergence region P. The output value at this time is determined by the individual differences of the light receiving elements that make up the photometric system in the measurement unit 60 and the circuit that measures the light receiving element output. Therefore, in this embodiment, this characteristic is utilized to determine the maximum output value (maximum device output value) by measuring a high concentration calibrator, and this value is stored outside the device 1 or automatic analyzer 1 as a virtual calibrator measurement value or a unique calibration measurement value (measurement value at calibration point Cp).

Since this unique calibrator measurement value Cp is a value determined by individual differences in the photometric system of the device, it is not possible to have this information stored in containers or racks containing each reagent, as it is not known which device it will be used in. For this reason, it is preferable to store it in each individual device 1. However, the storage location is not limited to the measurement unit, and it may be stored anywhere within the device as long as it is accessible for use as a device-specific value, or it may be stored outside the device. For example, if it can be obtained by a communication means, it may be stored on a server or external storage unit. Furthermore, it may be stored in other storage units that are easily removable, such as USB.

The number of calibrator measurement values (calibration points) used to create the calibration curve is not limited to the number mentioned above. The position of the inflection point IP of the calibration curve can also be controlled by changing the number of calibrator measurement values. For example, as shown in (a) and (b) of FIG. 3, by increasing the number of calibration points C near the inflection point IP, that is, by increasing the information weight of the part where no change in the photometric value occurs near high luminance, it is possible to determine the curvature of the curve connecting the calibration curve in the linear region of the low to medium luminance region and the calibration curve in the convergence region. If the number of calibration points C is small, there is room for the calibration curve to fluctuate, but by increasing the number of calibration points C on the high concentration side (high luminance side), it becomes possible to better reflect the characteristics of the calibration curve and reduce the room for fluctuation of the calibration curve.

Although one embodiment of the present invention has been described above, the present invention is not limited to the above-described embodiment, and can be modified in various ways without departing from the gist of the present invention. For example, in the present invention, the configuration of the measurement unit, etc. is not limited to the above-described configuration. Furthermore, some or all of the above-described embodiments may be combined, or part of the configuration may be omitted from one of the above-described embodiments, without departing from the gist of the present invention.

1 Automatic analysis device 10 Control unit 16 Measurement control unit 16b, 116b Calibration data storage unit 17 Calibration curve calibration unit 60 Measurement unit

Claims

An analysis method for an automatic analyzer, which converts a measurement result obtained from the automatic analyzer into a concentration value by reacting a sample with a reagent corresponding to an analysis item using a calibration curve calibrated by calibration using a calibrator previously adjusted to a known concentration, and analyzes a measurement target component contained in the sample, comprising:
The calibration curve has a linear region where the measured value increases with increasing concentration, and a convergence region where the measured value does not change even if the concentration increases,
The calibration of the standard curve by the calibration is performed using two or more calibrator measurement values located in the linear region and one or more unique calibrator measurement values located in the convergence region;
An analysis method for an automatic analyzer, characterized in that at least one of the unique calibrator measurement values located in the convergence zone used in the calibration is a value unique to each individual automatic analyzer, and is read and used from a value stored in advance within each individual automatic analyzer or in a location other than each individual automatic analyzer.
The analysis method for an automatic analyzer according to claim 1, characterized in that calibration is performed using two or more of the calibrator measurement values located in the linear region and two of the unique calibrator measurement values located in the convergence region.
The analysis method for an automatic analyzer according to claim 1 or 2, characterized in that the unique calibrator measurement value is a maximum saturation light intensity value measured by each automatic analyzer.
The analysis method for an automatic analyzer according to claim 1 or 2, characterized in that the unique calibrator measurement value is within the range of 95% to 100% of the maximum saturated light intensity value measured by each individual automatic analyzer.
An automatic analyzer that converts a measurement result obtained by reacting a sample with a reagent corresponding to an analysis item into a concentration value using a calibration curve calibrated by calibration using a calibrator previously adjusted to a known concentration, and analyzes a measurement target component contained in the sample,
an introduction section for receiving the sample and the reagent containing a labeling substance;
a measurement unit that measures the amount of light obtained from the labeling substance and measures the measurement target component contained in the sample qualitatively or quantitatively based on the measured value and using the calibrated calibration curve;
a calibration curve calibration unit that calibrates the calibration curve by calibration in cooperation with the measurement unit;
Equipped with
The calibration curve has a linear region where the measured value increases with increasing concentration, and a convergence region where the measured value does not change even if the concentration increases,
the calibration curve calibration unit creates the calibration curve using two or more calibrator measurement values located in the linear region and one or more specific calibrator measurement values located in the convergence region specific to the automatic analyzer, the specific calibrator measurement values being stored in advance in the automatic analyzer or outside the automatic analyzer.
An automatic analyzer characterized by:
The automatic analyzer according to claim 5, characterized in that calibration is performed using two or more of the calibrator measurement values located in the linear region and two of the unique calibrator measurement values located in the convergence region.
The automated analyzer according to claim 5 or 6, characterized in that at least one of the unique calibrator measurement values is a maximum saturation light intensity value measured by the individual automated analyzer.
The automated analyzer according to claim 5 or 6, characterized in that at least one of the unique calibrator measurement values is within a range of 95% to 100% of the maximum saturated light intensity value measured by the individual automated analyzer.