Medical inspection device, medical inspection method, calibration method, and program

Abstract

To perform conversion into a measured value representing the density of a component included in an analyte based upon measured absorbance by enabling generation of a calibration curve for quantization covering a range from low density to high density.SOLUTION: A medical inspection device has a first calibration curve generation part, a second calibration curve generation part, and a conversion part. The first calibration curve generation part generates a first calibration curve based upon first absorbance output by a measuring instrument taking a measurement with an inspection reagent mixed with a standard sample of known density. The second calibration curve generation part generates a second calibration curve based upon a rate of variation in first absorbance. The conversion part outputs a measured value obtained by converting second absorbance, output by the measuring instrument taking a measurement with the inspection reagent mixed with an analyte, into the density of a component included in the analyte by the use of the first calibration curve and / or the second calibration curve.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The embodiments disclosed in this specification and the drawings relate to a medical examination apparatus, a medical examination method, a calibration curve creation method, and a program.

Background Art

[0002] Conventionally, in the field of specimen examination and the like, a specimen examination apparatus using absorbance has been used. In a specimen examination apparatus using absorbance, the absorbance (so-called raw data) output as measurement data by a measuring instrument that measures a specimen mixed with a test reagent is converted into a measured value representing the concentration of a component contained in the specimen using a calibration curve. In a specimen examination apparatus, for example, conversion to the concentration of a component contained in a specimen is performed using a calibration curve prepared in advance from the amount of change in absorbance per unit time by the Rate method.

[0003] By the way, in the Rate method, the conversion from absorbance to concentration is valid on the premise that the reaction of the test reagent in the measurement range is linear (the reaction proceeds at a constant rate) within the measurement time. However, depending on the component contained in the specimen and the test item of the specimen, this premise may not hold. For example, in the sialylated glycoprotein (KL-6), which is a component to be examined in a specimen examination apparatus, the way of scattering changes depending on whether the concentration is low or high, resulting in a phenomenon where the absorbance decreases when the concentration becomes high, and the premise in the Rate method may not hold. Here, as factors causing the phenomenon that the absorbance decreases when the sialylated glycoprotein is at a high concentration, for example, factors such as an increase in the diameter of the aggregate or the occurrence of precipitation are considered, but the actual factors have not been elucidated. For this reason, for example, it has been difficult to develop a test reagent that can cover a range from a low value to a high value for components contained in a specimen such as sialylated glycoprotein and to create a calibration curve for quantification.

[0004] In this regard, conventionally, a calibration curve is created in advance for each of a photometric analyzer and a nephelometer by measuring the light intensity at multiple points using a sample with a known concentration, and a proposal has been made for an automatic analyzer that converts the light intensity of a sample to be inspected into a concentration by combining multiple calibration curves. In the conventional technique, an allowable concentration range of the calibration curve is set for each of the photometric analyzers, and any one of the multiple photometric analyzers is selected according to the concentration of the sample calculated based on the light detected by each of the multiple photometric analyzers within the set allowable concentration range, and the concentration based on the light detected by the selected photometric analyzer is determined as the concentration of the sample.

[0005] However, in the conventional technique, in order to create multiple calibration curves in advance, it is considered necessary to measure a sample with a known concentration using multiple photometric analyzers, and calibration to match the measurement accuracy in each photometric analyzer is also required. For this reason, it is considered that the processing and steps for creating multiple calibration curves in advance become complicated.

Prior Art Documents

Patent Documents

[0006]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0007] The problem to be solved by the embodiments disclosed in this specification and the drawings is to convert the measured absorbance into a measured value representing the concentration of the components contained in the specimen by enabling the creation of a calibration curve that covers the range from low concentration to high concentration and enables quantification. However, the problems to be solved by the embodiments disclosed in this specification and the drawings are not limited to the above problems. The problems corresponding to the effects of each configuration shown in the embodiments described later can also be regarded as other problems.

Means for Solving the Problems

[0008] The medical inspection device according to the embodiment includes a first calibration curve creation unit, a second calibration curve creation unit, and a conversion unit. The first calibration curve creation unit creates a first calibration curve based on the first absorbance output by a measuring instrument obtained by mixing a test reagent with a standard sample having a known concentration and performing measurement. The second calibration curve creation unit creates a second calibration curve based on the change rate of the first absorbance. The conversion unit outputs a measured value obtained by converting the second absorbance output by the measuring instrument obtained by mixing the test reagent with a specimen and performing measurement into the concentration of the component contained in the specimen, using the first calibration curve and / or the second calibration curve.

Brief Description of Drawings

[0009]

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[0010] Hereinafter, a medical examination apparatus, a medical examination method, a calibration curve creation method, and a program according to an embodiment will be described with reference to the drawings. The medical examination apparatus is, for example, a specimen examination apparatus that examines a component (hereinafter referred to as "examination target") contained in a specimen such as a tumor collected from a patient who has come to a medical institution such as a hospital for diagnosis, based on the measured absorbance (Absorbance Unit: A.U. or Abs).

[0011] (First Embodiment) [Configuration of Medical Examination Apparatus] FIG. 1 is a diagram showing an example of the functional configuration of the medical examination apparatus according to the first embodiment. The medical examination apparatus 100 includes, for example, a measurement unit 120, a processing circuit 140, and a storage unit 160.

[0012] The measurement unit 120 measures the absorbance of a specimen mixed with a test reagent. The measurement unit 120 measures, for example, the amount of light absorbed by the examination target contained in the specimen by irradiating light on a specimen mixed with a test reagent housed in a specimen container and detecting the light transmitted through the specimen with a photometer, thereby measuring the absorbance representing the amount of light absorbed. The measurement unit 120 sequentially outputs the absorbance of the examination target measured during the measurement period to the processing circuit 140 as measurement data. The configuration of the measurement unit 120 and the method for measuring absorbance in the measurement unit 120 are not particularly defined.

[0013] The measurement unit 120 is an example of a "measuring instrument".

[0014] The processing circuit 140 obtains a measurement value representing the concentration of the analyte contained in the specimen based on the absorbance (so-called raw data) sequentially output as measurement data by the measurement unit 120. At this time, the processing circuit 140 obtains the measurement value of the analyte by converting the absorbance into concentration using a calibration curve created in advance. The calibration curve used by the processing circuit 140 for the conversion of absorbance is created in advance by the processing circuit 140 based on the absorbance obtained by measuring a sample with a known concentration by the measurement unit 120. The method for creating the calibration curve in the processing circuit 140 will be described later. The processing circuit 140 presents the information representing the obtained measurement value to the user of the medical testing device 100, such as an examiner or a doctor who performs the test on the specimen, by displaying it on a display device (not shown) such as an LCD (Liquid Crystal Display) for presenting information.

[0015] The storage unit 160 stores the calibration curve created in advance by the processing circuit 140. The storage unit 160 stores the calibration curve created by the processing circuit 140 prior to actually performing the test on the specimen, that is, the calibration curve created in advance. The calibration curve stored in the storage unit 160 is read out when the processing circuit 140 converts the absorbance into concentration in the actual test of the specimen. The storage unit 160 is realized by, for example, a semiconductor memory element such as a ROM (Read Only Memory), a RAM (Random Access Memory), or a flash memory, a hard disk drive (HDD), an optical disk, or the like.

[0016] In FIG. 1, the measurement unit 120 and the storage unit 160 are provided in the medical examination device 100. That is, the measurement unit 120, the processing circuit 140, and the storage unit 160 show an integrated configuration. However, the configuration of the medical examination device 100 is not limited to the configuration shown in FIG. 1. For example, the function of the processing circuit 140 may be realized by a computer device such as a personal computer (PC) installed in a hospital examination room as the main device of the medical examination device 100. In this case, the medical examination device 100 (computer device) is connected to a display device (not shown) and an input interface (not shown) for the user to input information for controlling the function of the processing circuit 140. The display device and the input interface may be connected to the medical examination device 100 by wireless communication. The function of the processing circuit 140 may be realized by a server device on a network (not shown) as the main device of the medical examination device 100. In this case, at least a display device and an input interface may be installed in the hospital examination room, and the server device, which is the main device of the medical examination device 100, communicates with the display device and the input interface via a network (not shown). Furthermore, only some of the functions described later may be realized by the server device. In this case, the server device, which is the main device of the medical examination device 100, and the server device in which some functions of the processing circuit 140 are realized communicate with each other via a network (not shown).

[0017] The network (not shown) includes, for example, the Internet, WAN (Wide Area Network), LAN (Local Area Network), provider devices, radio base stations, and the like. The input interface is realized, for example, by a mouse, keyboard, touch panel, microphone, or the like. When the input interface is a touch panel, the input interface may be formed integrally with a display device connected to the medical examination device 100. In this specification, the input interface is not limited to only those provided with physical operation components such as the above-described mouse and keyboard. For example, an electric signal processing circuit that receives an electric signal corresponding to an input operation from an external input device provided separately from the medical examination device 100 and outputs this electric signal to the medical examination device 100 is also included in the examples of the input interface.

[0018] When the functions of the processing circuit 140 are realized by a computer device, server device, or the like as the main body device of the medical examination device 100, the measurement unit 120 and the storage unit 160 may be configured as a measurement device and a storage device that are directly connected to the outside of the main body device of the medical examination device 100 or connected via a network (not shown). In this case, the output of the absorbance measured by the measurement unit 120 to the processing circuit 140, the storage of the calibration curve created by the processing circuit 140 in the storage unit 160, and the reading of the calibration curve stored in the storage unit 160 by the processing circuit 140 may be performed by a signal line directly connected to the medical examination device 100 or communication via a network (not shown). Further, the measurement unit 120 (measurement device) may not be connected to the medical examination device 100, and the measured absorbance (measurement data) may be configured to be output to the processing circuit 140 when the user performs an input operation on an input interface (not shown) connected to the medical examination device 100.

[0019] [Functional Configuration of Processing Circuit] The processing circuit 140 executes processes such as an acquisition function 142, a calibration curve creation function 144, a conversion function 146, and a measurement value output function 148. The calibration curve creation function 144 executes processes such as a first calibration curve creation function 1442 and a second calibration curve creation function 1444. The conversion function 146 executes processes such as a calibration curve switching function 1462.

[0020] The processing circuit 140 realizes each function of the acquisition function 142, the calibration curve creation function 144 (including the first calibration curve creation function 1442 and the second calibration curve creation function 1444), the conversion function 146, the calibration curve switching function 1462, and the measurement value output function 148, for example, by executing a program (software) stored in a memory (storage unit), not shown, by a hardware processor. The memory, not shown, is realized by, for example, a semiconductor memory element such as a ROM, a RAM, a flash memory, a hard disk drive, an optical disk, or the like.

[0021] A hardware processor means circuitry such as, for example, a CPU (Central Processing Unit), a GPU (Graphics Processing Unit), an LSI (Large Scale Integration), a SOC (System On Chip), an application specific integrated circuit (ASIC), a programmable logic device (e.g., a Simple Programmable Logic Device (SPLD) or a Complex Programmable Logic Device (CPLD), a Field Programmable Gate Array (FPGA)). Instead of storing a program in a memory (not shown), it may be configured to directly incorporate the program into the circuitry of the hardware processor. In this case, the hardware processor realizes each function by reading and executing the program incorporated in the circuitry. The hardware processor is not limited to being configured as a single circuit, and may be configured as one hardware processor by combining a plurality of independent circuits to realize each function. A plurality of components may be integrated into one hardware processor to realize each function. A plurality of components may be incorporated into one dedicated LSI to realize each function. Here, the program (software) may be stored in advance in a semiconductor memory element such as a ROM, a RAM, a flash memory, or a storage device (a storage device including a non-transitory storage medium) constituting a storage device such as a hard disk drive (HDD), or may be stored in a removable storage medium (a non-transitory storage medium) such as a DVD or a CD-ROM, and may be installed in the storage device provided in the medical inspection device 100 by mounting the storage medium on a drive device provided in the medical inspection device 100. The program (software) may be downloaded in advance from another computer device via a network (not shown) and installed in the storage device provided in the medical inspection device 100.The program (software) installed in the storage device provided in the medical examination device 100 may be transferred to the processing circuit provided in the medical examination device 100 and executed.

[0022] The acquisition function 142 acquires the absorbance (measurement data) output by the measurement unit 120. The acquisition function 142 outputs the acquired absorbance to each of the calibration curve creation function 144 and the conversion function 146. The acquisition function 142 may be configured to store the acquired absorbance in the storage unit 160 and output a notification indicating this to each of the calibration curve creation function 144 and the conversion function 146. In this case, by each of the calibration curve creation function 144 and the conversion function 146 reading the absorbance stored in the storage unit 160, it becomes equivalent to a configuration in which the absorbance acquired by the acquisition function 142 is output to each of the calibration curve creation function 144 and the conversion function 146. The method for acquiring the absorbance (measurement data) in the acquisition function 142 may be any method. For example, the acquisition function 142 may acquire the absorbance by reading the absorbance directly stored in the storage unit 160 by the measurement unit 120. For example, the acquisition function 142 may acquire the absorbance input by the user operating the input interface.

[0023] The calibration curve creation function 144 creates a calibration curve based on the absorbance output by the acquisition function 142. More specifically, the calibration curve creation function 144 creates a calibration curve based on the absorbance output by the measurement unit 120 that measures a sample (hereinafter referred to as a "standard sample") with a known concentration of the test reagent mixed therein and acquired and output by the acquisition function 142. The calibration curve creation function 144 stores the created calibration curve in the storage unit 160.

[0024] The first calibration curve creation function 1442 creates a first calibration curve based on the absorbance output by the acquisition function 142 (the absorbance measured for a standard sample mixed with the test reagent). The first calibration curve created by the first calibration curve creation function 1442 is a calibration curve created from the change in absorbance per unit time (hereinafter referred to as the "absorbance change amount") by the Rate method. Since the method for creating the first calibration curve by the first calibration curve creation function 1442 is the same as the existing method for creating a calibration curve by the Rate method, detailed explanations regarding the operations and processes in the method for creating the first calibration curve are omitted. The first calibration curve creation function 1442 stores the created first calibration curve in the storage unit 160.

[0025] The second calibration curve creation function 1444 creates a second calibration curve based on the change rate of the change amount (absorbance change amount) of the absorbance output by the acquisition function 142 (the absorbance measured for a standard sample mixed with the test reagent). The second calibration curve created by the second calibration curve creation function 1444 obtains the maximum value of the absorbance change amount by differentiating the absorbance change amount, and creates the second calibration curve based on the obtained maximum value.

[0026] Here, the method for creating the second calibration curve in the second calibration curve creation function 1444 will be described. FIG. 2 is a diagram showing an example of the temporal change in absorbance measured by the measurement unit 120 provided in the medical inspection apparatus 100 according to the first embodiment. FIG. 3 is a diagram showing an example of the processing when the second calibration curve creation function 1444 provided in the medical inspection apparatus 100 according to the first embodiment creates a second calibration curve.

[0027] FIG. 2 shows, for example, an example of the temporal change in the absorbance [A.U.] (or [Abs]) measured for each of four standard samples mixed with the test reagent and measuring light of a specific wavelength. In FIG. 2, line 1 is an example of the temporal change in the absorbance of a standard sample with a known concentration of 510 [U / L], line 2 is an example of the temporal change in the absorbance of a standard sample with a known concentration of 1020 [U / L], line 3 is an example of the temporal change in the absorbance of a standard sample with a known concentration of 3090 [U / L], and line 4 is an example of the temporal change in the absorbance of a standard sample with a known concentration of 6010 [U / L].

[0028] In FIG. 2, in Systems 1 and 2 with low concentrations, the temporal change in absorbance is constant (the absorbance changes linearly), while in Systems 3 and 4 with high concentrations, the temporal change in absorbance is not constant, and the amount of change in absorbance decreases with the passage of time. In particular, in System 4, the absorbance decreases as time passes and falls below the absorbance of System 3. For this reason, conventionally, such a test reagent with such characteristics can be used for testing specimens (test targets) with low concentrations, but it is determined that it cannot be used for testing specimens (test targets) with high concentrations.

[0029] The second calibration curve creation function 1444 obtains the maximum value of the absorbance change amount (difference value) by differentiating the temporal change in absorbance showing a change as in the example shown in FIG. 2. Then, the second calibration curve creation function 1444 creates a second calibration curve by connecting the obtained maximum values to each other.

[0030] FIG. 3(a) shows an example of the temporal change in the differential value (difference value) of the absorbance change amount obtained by differentiating the absorbance change amount [A.U. / s] (or [Abs / s]), which is the temporal change in absorbance shown in FIG. 2. In FIG. 3(a), the maximum value of the absorbance change amount in each system is indicated by a "circle mark". And FIG. 3(b) shows an example of the second calibration curve created by plotting the maximum values shown in FIG. 3(a) in association with the known concentrations in each system and connecting the maximum values to each other.

[0031] In this way, the second calibration curve creation function 1444 creates a second calibration curve based on the change rate of the absorbance change amount obtained from the absorbance output by the acquisition function 142. The second calibration curve creation function 1444 stores the created second calibration curve in the storage unit 160.

[0032] The first calibration curve creation function 1442 is an example of the "first calibration curve creation unit". The second calibration curve creation function 1444 is an example of the "second calibration curve creation unit". When the first calibration curve creation function 1442 creates the first calibration curve and when the second calibration curve creation function 1444 creates the second calibration curve, the absorbance output by the acquisition function 142 (the absorbance measured for the standard sample mixed with the test reagent) is an example of the "first absorbance". The amount of change in absorbance for the first calibration curve creation function 1442 to create the first calibration curve and the second calibration curve creation function 1444 to create the second calibration curve is an example of the "first amount of change in absorbance". The maximum value of the amount of change in absorbance required for the second calibration curve creation function 1444 to create the second calibration curve is an example of the "change rate of the first absorbance" and the "maximum value of the first amount of change in absorbance".

[0033] Returning to FIG. 1, the conversion function 146 obtains the measured value of the test object by converting the absorbance (the absorbance measured for the specimen mixed with the test reagent) output by the acquisition function 142 into concentration using the first calibration curve and the second calibration curve stored in the storage unit 160 in the actual test of the specimen. At this time, the conversion function 146 obtains the slope of the absorbance (that is, the amount of change in absorbance) and the maximum value of the amount of change in absorbance respectively based on the absorbance output by the acquisition function 142. Then, the conversion function 146 outputs the obtained amount of change in absorbance and the maximum value of the amount of change in absorbance to the calibration curve switching function 1462.

[0034] The calibration curve switching function 1462 switches the calibration curve used for conversion when the conversion function 146 converts absorbance into concentration. More specifically, the calibration curve switching function 1462 switches the calibration curve used for converting absorbance into concentration to the first calibration curve or the second calibration curve.

[0035] In the medical examination device 100, a point (hereinafter referred to as the "switching point") at which the calibration curve switching function 1462 switches the calibration curve is preset. In other words, in the medical examination device 100, the upper limit absorbance change amount for converting absorbance into concentration using the first calibration curve created by the existing rate method is preset as the switching point. The switching point is set, for example, so as to exclude the range in which the value (measurement value) of the concentration converted from the absorbance becomes inaccurate in each of the first calibration curve and the second calibration curve. The switching point is set, for example, after the first calibration curve creating function 1442 creates the first calibration curve and the second calibration curve creating function 1444 creates the second calibration curve, by displaying both the first calibration curve and the second calibration curve on a display device (not shown) and presenting them to the user, and the user performs an input operation on an input interface (not shown). The timing at which the switching point is set may be any timing as long as it is after the calibration curve creating function 144 creates each of the first calibration curve and the second calibration curve and before actually examining the specimen, that is, as long as it is a timing prior to the actual examination of the specimen in the medical examination device 100.

[0036] Here, the switching point at which the calibration curve switching function 1462 switches the calibration curve will be described. FIG. 4 is a diagram showing an example of the switching point at which the calibration curve switching function 1462 provided in the medical examination device 100 according to the first embodiment switches between the first calibration curve and the second calibration curve. FIG. 4(a) shows an example of the first calibration curve created by the first calibration curve creating function 1442, and FIG. 4(b) shows an example of the second calibration curve created by the second calibration curve creating function 1444.

[0037] In an example of the first calibration curve shown in Fig. 4(a), the slope changes where the converted concentration is 1000 [U / L], and further changes around 3000 [U / L]. This is because, for example, as in Line 3 and Line 4 shown in Fig. 2, when the concentration is high, the state where the change amount of absorbance decreases with the passage of time is included in the first calibration curve. For this reason, in the first calibration curve, it can be said that the range where the concentration is higher than 1000 [U / L] (range R1) is the range where the measured value of the concentration becomes inaccurate. On the other hand, in an example of the second calibration curve shown in Fig. 4(b), the slope changes where the converted concentration is 1000 [U / L], and further changes around 500 [U / L]. This is because, for example, as in Line 1 and Line 2 shown in Fig. 2, when the concentration is low, although the temporal change of absorbance is constant, when more time has passed, it is the maximum value of the original absorbance change amount. That is, in the time range shown in Fig. 2, since the maximum values of the absorbance change amounts in Line 1 and Line 2 are not represented, the reason is that the second calibration curve has to be created with an inaccurate maximum value of the absorbance change amount. For this reason, in the second calibration curve, it can be said that the range where the concentration is lower than 1000 [U / L] (range R2) is the range where the measured value of the concentration becomes inaccurate. For this reason, in the medical inspection device 100, the switching point is set so that the calibration curve used when the conversion function 146 converts absorbance into concentration excludes the range R1 of the first calibration curve and the range R2 of the second calibration curve. In the example shown in Fig. 4, the position where the converted concentration is 1000 [U / L] is set as the switching point P.

[0038] The calibration curve switching function 1462 switches the calibration curve used by the conversion function 146 to convert absorbance to concentration, based on the amount of change in absorbance output by the conversion function 146 and the maximum value of the amount of change in absorbance. More specifically, when the amount of change in absorbance output by the conversion function 146 is less than or equal to the cut-off value of the amount of change in absorbance determined by the set switching point P, the calibration curve switching function 1462 switches the calibration curve used by the conversion function 146 to convert absorbance to concentration to the first calibration curve. When the maximum value of the amount of change in absorbance output by the conversion function 146 is greater than the cut-off value of the maximum value of the amount of change in absorbance determined by the set switching point P, the calibration curve switching function 1462 switches the calibration curve used by the conversion function 146 to convert absorbance to concentration to the second calibration curve.

[0039] Here, the switching of the calibration curve by the calibration curve switching function 1462 will be described. FIG. 5 is a diagram showing an example in which the calibration curve switching function 1462 provided in the medical inspection apparatus 100 according to the first embodiment switches between the first calibration curve and the second calibration curve. FIG. 5 shows an example in which the position of a concentration of 1000 [U / L] in the example shown in FIG. 4 is set as the switching point P for switching between the first calibration curve and the second calibration curve.

[0040] In the first calibration curve shown in FIG. 5(a), the cut-off value A (=0.065 [A.U. / s]) of the amount of change in absorbance is determined by the switching point P. In the second calibration curve shown in FIG. 5(b), the cut-off value B (=0.04 [A.U. / s]) of the maximum value of the amount of change in absorbance is determined by the switching point P. In this case, when the amount of change in absorbance output by the conversion function 146 is less than or equal to the cut-off value A (=0.065 [A.U. / s]), the calibration curve switching function 1462 switches the calibration curve used by the conversion function 146 to convert absorbance to concentration to the first calibration curve. On the other hand, when the maximum value of the amount of change in absorbance output by the conversion function 146 is greater than the cut-off value B (=0.04 [A.U. / s]), the calibration curve switching function 1462 switches the calibration curve used by the conversion function 146 to convert absorbance to concentration to the second calibration curve.

[0041] The conversion function 146 obtains, as a measurement value, the concentration obtained by converting the absorbance output by the acquisition function 142 using the first calibration curve or the second calibration curve switched by the calibration curve switching function 1462.

[0042] The conversion function 146 and the calibration curve switching function 1462 are examples of a "conversion unit". The calibration curve switching function 1462 is an example of a "calibration curve switching unit". The absorbance output by the acquisition function 142 when the conversion function 146 converts absorbance to concentration (the absorbance measured for a sample mixed with a test reagent) is an example of a "second absorbance". The slope of the absorbance (change in absorbance) obtained by the conversion function 146 to convert absorbance to concentration is an example of a "second change in absorbance", and the maximum value of the change in absorbance is an example of a "maximum value of the second change in absorbance".

[0043] [An example of converting absorbance to concentration] Here, an example of the conversion function 146 converting absorbance to concentration will be described. As described above, when converting absorbance to concentration, the conversion function 146 obtains the change in absorbance and the maximum value of the change in absorbance, and uses the first calibration curve or the second calibration curve switched by the calibration curve switching function 1462 to obtain a measurement value representing the concentration converted from the absorbance output by the acquisition function 142. FIGS. 6 to 10 are diagrams showing an example of the conversion function 146 provided in the medical inspection apparatus 100 according to the first embodiment converting absorbance to concentration. In FIGS. 6 to 10, both the first calibration curve and the second calibration curve are shown for comparison.

[0044] FIG. 6 schematically shows an example of obtaining a measured value (hereinafter referred to as "measured value M") when the change amount of absorbance (hereinafter referred to as "change amount RATE(m)") obtained when the conversion function 146 converts absorbance to concentration is smaller than the threshold value A (=0.065 [A.U. / s]), and the maximum value of the absorbance change amount (hereinafter referred to as "maximum value Diff(m)") is smaller than the threshold value B (=0.04 [A.U. / s]). That is, the example shown in FIG. 6 schematically shows an example of how to obtain the measured value M when "RATE(m) < A" and "DIFF(m) < B". In the example shown in FIG. 6, since the change amount RATE(m) = 0.045 [A.U. / s], the calibration curve switching function 1462 determines that the selection condition (RATE(m) ≦ A) for selecting the first calibration curve is satisfied, and since the maximum value Diff(m) = 0.02 [A.U. / s], it determines that the selection condition (DIFF(m) > B) for selecting the second calibration curve is not satisfied. Therefore, the calibration curve switching function 1462 selects the first calibration curve and does not select the second calibration curve. Then, the calibration curve switching function 1462 switches the selected first calibration curve to the calibration curve used when the conversion function 146 converts absorbance to concentration. As a result, the conversion function 146 obtains the concentration (=600 [U / L]) corresponding to the change amount RATE(m) = 0.045 [A.U. / s] as the measured value M using the first calibration curve.

[0045] An example shown in Fig. 7 schematically shows an example of how to obtain the measured value M when "RATE(m) > A" and "DIFF(m) > B". In the example shown in Fig. 7, since the rate of change RATE(m) = 0.08 [A.U. / s], the calibration curve switching function 1462 determines that the selection condition for selecting the first calibration curve is not satisfied, and since the maximum value Diff(m) = 0.08 [A.U. / s], it determines that the selection condition for selecting the second calibration curve is satisfied. Therefore, the calibration curve switching function 1462 does not select the first calibration curve but selects the second calibration curve. Then, the calibration curve switching function 1462 switches the selected second calibration curve to the calibration curve used when the conversion function 146 converts absorbance to concentration. As a result, the conversion function 146 obtains the concentration (= 3200 [U / L]) corresponding to the maximum value Diff(m) = 0.08 [A.U. / s] as the measured value M using the second calibration curve.

[0046] An example shown in Fig. 8 schematically shows an example of how to obtain the measured value M when "RATE(m) < A" and "DIFF(m) > B". In the example shown in Fig. 8, since the rate of change RATE(m) = 0.05 [A.U. / s], the calibration curve switching function 1462 determines that the selection condition for selecting the first calibration curve is satisfied, and since the maximum value Diff(m) = 0.08 [A.U. / s], it determines that the selection condition for selecting the second calibration curve is satisfied. That is, in the example shown in Fig. 8, the calibration curve switching function 1462 determines that both the rate of change RATE(m) and the maximum value Diff(m) satisfy the selection conditions. In this case, the calibration curve switching function 1462 preferentially selects the first calibration curve. That is, the calibration curve switching function 1462 selects the first calibration curve and does not select the second calibration curve. Then, the calibration curve switching function 1462 switches the selected first calibration curve to the calibration curve used when the conversion function 146 converts absorbance to concentration. As a result, the conversion function 146 obtains the concentration (= 800 [U / L]) corresponding to the rate of change RATE(m) = 0.05 [A.U. / s] as the measured value M using the first calibration curve.

[0047] Incidentally, in an example shown in FIG. 8, the calibration curve switching function 1462 determines that both the change amount RATE(m) and the maximum value Diff(m) satisfy the selection conditions. Therefore, the calibration curve switching function 1462 may select both the first calibration curve and the second calibration curve, and use both the first calibration curve and the second calibration curve as the calibration curves used when the conversion function 146 converts absorbance into concentration. In this case, the conversion function 146 may obtain the concentration (=800 [U / L]) corresponding to the change amount RATE(m)=0.05 [A.U. / s] using the first calibration curve, and obtain the concentration (=3200 [U / L]) corresponding to the maximum value Diff(m)=0.08 [A.U. / s] using the second calibration curve, and use the average value of the obtained respective concentrations as the measured value M.

[0048] An example shown in FIG. 9 schematically shows an example of a method for obtaining the measured value M when “RATE(m)>A” and “DIFF(m)<B”. In the example shown in FIG. 9, the calibration curve switching function 1462 determines that the selection condition for selecting the first calibration curve is not satisfied because the change amount RATE(m)=0.07 [A.U. / s], and determines that the selection condition for selecting the second calibration curve is not satisfied because the maximum value Diff(m)=0.035 [A.U. / s]. That is, in the example shown in FIG. 9, the calibration curve switching function 1462 determines that both the change amount RATE(m) and the maximum value Diff(m) do not satisfy the selection conditions. In this case, the calibration curve switching function 1462 preferentially selects the first calibration curve. That is, the calibration curve switching function 1462 selects the first calibration curve and does not select the second calibration curve. Then, the calibration curve switching function 1462 switches the selected first calibration curve to the calibration curve used when the conversion function 146 converts absorbance into concentration. Thereby, the conversion function 146 obtains the concentration (=1400 [U / L]) corresponding to the change amount RATE(m)=0.07 [A.U. / s] as the measured value M using the first calibration curve.

[0049] Incidentally, in an example shown in FIG. 9, the calibration curve switching function 1462 determines that both the change amount RATE(m) and the maximum value Diff(m) do not satisfy the selection conditions. For this reason, the calibration curve switching function 1462 may select both the first calibration curve and the second calibration curve, and use both the first calibration curve and the second calibration curve as the calibration curves used when the conversion function 146 converts the absorbance into the concentration. In this case, the conversion function 146 may obtain the concentration (= 1400 [U / L]) corresponding to the change amount RATE(m) = 0.07 [A.U. / s] using the first calibration curve, and obtain the concentration (= 900 [U / L]) corresponding to the maximum value Diff(m) = 0.035 [A.U. / s] using the second calibration curve, and use the average value of the obtained respective concentrations as the measured value M.

[0050] An example shown in FIG. 10 schematically shows another example of how to obtain the measured value M when "RATE(m) < A" and "DIFF(m) > B". In the example shown in FIG. 10, since the rate of change RATE(m) = 0.06 [A.U. / s], it is determined that the selection condition for selecting the first calibration curve is satisfied, and since the maximum value Diff(m) = 0.14 [A.U. / s], it is determined that the selection condition for selecting the second calibration curve is satisfied. That is, also in the example shown in FIG. 10, the calibration curve switching function 1462 determines that both the rate of change RATE(m) and the maximum value Diff(m) satisfy the selection conditions. In this case, the calibration curve switching function 1462 may preferentially select the first calibration curve as described above, but here, the calibration curve switching function 1462 selects both the first calibration curve and the second calibration curve, and both the first calibration curve and the second calibration curve are used as the calibration curves when the conversion function 146 converts absorbance to concentration. Here, in the example shown in FIG. 10, for the first calibration curve, when the concentration increases, the change in absorbance decreases. Therefore, for the first calibration curve shown in FIG. 10, there are two positions (points) where it intersects the cut-off value A. In this case, the conversion function 146 obtains two concentrations, concentration = 900 [U / L] and concentration = 5000 [U / L], as the concentrations corresponding to the rate of change RATE(m) = 0.06 [A.U. / s] using the first calibration curve. Further, the conversion function 146 obtains the concentration corresponding to the maximum value Diff(m) = 0.14 [A.U. / s] using the second calibration curve. However, in the example shown in FIG. 10, the second calibration curve does not correspond to concentrations exceeding concentration = 6000 [U / L]. In this case, the conversion function 146 estimates the second calibration curve for the range exceeding concentration = 6000 [U / L], that is, extrapolates the second calibration curve, and obtains concentration = 6400 [U / L] as the concentration corresponding to the maximum value Diff(m) = 0.14 [A.U. / s]. Then, the conversion function 146 sets the concentration = 6400 [U / L] obtained from the second calibration curve as the measured value M among the three obtained concentrations. That is, when two concentrations are obtained from the first calibration curve, the conversion function 146 exceptionally does not prioritize the first calibration curve, but sets the concentration obtained from the second calibration curve as the measured value M.However, even when two concentrations are obtained from the first calibration curve, if the maximum value Diff(m) does not satisfy the selection condition (DIFF(m) > B) for selecting the second calibration curve, the conversion function 146 uses the lower of the two concentrations obtained from the first calibration curve, concentration = 900 [U / L], as the measured value M. Here, in the example shown in FIG. 10, a case where two concentrations are obtained from the first calibration curve is shown. However, depending on the first calibration curve, more concentrations may be obtained. That is, there may be a case where a plurality of concentrations are obtained from the first calibration curve. Even in this case, the conversion function 146 uses the lower of the plurality of concentrations obtained from the first calibration curve as the measured value M.

[0051] In this way, the conversion function 146 obtains the absorbance change amount (change amount RATE(m)) and the maximum value of the absorbance change amount (maximum value Diff(m)) based on the absorbance output by the acquisition function 142, and uses the first calibration curve or the second calibration curve switched by the calibration curve switching function 1462 based on the obtained change amount RATE(m) and maximum value Diff(m) to obtain the concentration obtained by converting the absorbance output by the acquisition function 142 as the measured value (measured value M). The conversion function 146 outputs the obtained measured value to the measured value output function 148.

[0052] The cut-off value A is an example of the "first cut-off value", and the cut-off value B is an example of the "second cut-off value". The selection condition (RATE(m) ≤ A) for selecting the first calibration curve is an example of the "first selection condition", and the selection condition (DIFF(m) > B) for selecting the second calibration curve is an example of the "second selection condition".

[0053] Returning to FIG. 1, the measurement value output function 148 presents the measurement values output by the conversion function 146 to the user. More specifically, the measurement value output function 148 generates a display image including information representing the measurement values output by the conversion function 146, and outputs the generated display image to a display device (not shown) for display, thereby presenting it to the user of the medical examination device 100. As described above, when the user sets a switching point, the measurement value output function 148 may generate a display image that simultaneously shows the first calibration curve created by the first calibration curve creation function 1442 and the second calibration curve created by the second calibration curve creation function 1444, and display it on a display device (not shown).

[0054] [Processing of Medical Examination Device] Next, the overall operation of the medical examination device 100 will be described. FIG. 11 is a flowchart showing an example of the processing flow in the medical examination device 100 according to the first embodiment. FIG. 11(a) shows a flowchart showing an example of the processing flow for creating each of the first calibration curve and the second calibration curve prior to the examination of the specimen in the medical examination device 100, and FIG. 11(b) shows a flowchart showing an example of the processing flow when actually examining the specimen in the medical examination device 100.

[0055] First, with reference to FIG. 11(a), the processing flow for creating each of the first calibration curve and the second calibration curve will be described.

[0056] The acquisition function 142 acquires, for example, the absorbance (measurement data) output by the measurement unit 120 that has measured a standard sample with a known concentration of the test reagent mixed (step S100). The acquisition function 142 outputs the acquired absorbance to each of the calibration curve creation function 144 and the conversion function 146. At this time, the acquisition function 142 may generate a change amount of absorbance per unit time (absorbance change amount) based on the acquired absorbance and output it to each of the calibration curve creation function 144 and the conversion function 146.

[0057] The first calibration curve creation function 1442 included in the calibration curve creation function 144 creates a first calibration curve based on the absorbance output by the acquisition function 142 (step S102). When the acquisition function 142 outputs a change amount of absorbance, the first calibration curve creation function 1442 creates a first calibration curve based on the change amount of absorbance.

[0058] The second calibration curve creation function 1444 included in the calibration curve creation function 144 creates a second calibration curve based on the change rate of the change amount of absorbance (change amount of absorbance) output by the acquisition function 142 (step S104). When the acquisition function 142 outputs a change amount of absorbance, the second calibration curve creation function 1444 creates a second calibration curve based on the change amount of absorbance output by the acquisition function 142.

[0059] After that, when the user sets a switching point (step S106), the calibration curve creation function 144 (which may be the first calibration curve creation function 1442 and the second calibration curve creation function 1444) stores the first calibration curve and the second calibration curve with the switching point set in the storage unit 160 (step S108).

[0060] In this way, the medical examination device 100 creates each of the first calibration curve and the second calibration curve corresponding to the test reagent.

[0061] Subsequently, with reference to FIG. 11(b), the processing flow for actually examining a specimen will be described.

[0062] The acquisition function 142 acquires the absorbance (measurement data) output by the measurement unit 120 that measures a specimen (a specimen mixed with a test reagent) to be actually examined (step S200). The acquisition function 142 outputs the acquired absorbance to each of the calibration curve creation function 144 and the conversion function 146. Also at this time, the acquisition function 142 may generate a change amount of absorbance based on the acquired absorbance and output it to each of the calibration curve creation function 144 and the conversion function 146.

[0063] The conversion function 146 determines the slope of the absorbance (change in absorbance) and the maximum value of the change in absorbance respectively based on the absorbance output by the acquisition function 142 (step S202). When the acquisition function 142 outputs the change in absorbance, the conversion function 146 determines only the maximum value of the change in absorbance. The conversion function 146 outputs the determined change in absorbance and the maximum value of the change in absorbance to the calibration curve switching function 1462.

[0064] The calibration curve switching function 1462 reads the first calibration curve and the second calibration curve stored in the storage unit 160 from the storage unit 160 (step S204). Then, based on the switching points set for each of the read first calibration curve and second calibration curve, the change in absorbance output by the conversion function 146, and the maximum value of the change in absorbance, the calibration curve switching function 1462 switches the calibration curve used when the conversion function 146 converts absorbance to concentration (step S206).

[0065] The conversion function 146 uses the calibration curve (the first calibration curve or / and the second calibration curve) switched by the calibration curve switching function 1462 to convert the absorbance output by the acquisition function 142 into concentration (measurement value) (step S208). The conversion function 146 outputs the converted concentration (measurement value) to the measurement value output function 148.

[0066] The measurement value output function 148 presents the concentration (measurement value) output by the conversion function 146 to the user (step S210).

[0067] In this way, the medical inspection device 100 uses the first calibration curve or / and the second calibration curve to convert the absorbance output by the measurement unit 120 into concentration, and presents it to the user as the measurement value of the inspection of the specimen.

[0068] In this way, in the medical examination apparatus 100, the calibration curve creation function 144 provided in the processing circuit 140 creates each of the first calibration curve and the second calibration curve based on the absorbance output by the measurement unit 120 and stores them in the storage unit 160 before actually examining the specimen in the medical examination apparatus 100. Thereby, in the medical examination apparatus 100, for example, even when using a test reagent that can conventionally be used for examining a specimen (test target) with a low concentration but cannot be used for examining a specimen (test target) with a high concentration, the specimen (test target) can be examined more accurately. Then, when actually examining the specimen, the medical examination apparatus 100 uses the first calibration curve or / and the second calibration curve to convert the absorbance output by the measurement unit 120 into a concentration, and presents it to the user as a measurement value obtained by examining the specimen (test target). Thereby, the user using the medical examination apparatus 100 can confirm a more accurate examination result of the specimen (test target).

[0069] [Comparative Example of Concentrations Obtained by Converting Absorbance] Here, in the medical examination apparatus 100, the difference between the measured value M obtained by using only the first calibration curve created by the existing rate method and the measured value M obtained by switching between the first calibration curve and the second calibration curve will be described. FIG. 12 is a diagram showing an example of comparing the measured value M obtained by using only the first calibration curve and the measured value M obtained by using the first calibration curve and the second calibration curve in the medical examination apparatus 100 according to the first embodiment. In FIG. 12, for example, the measured value of the concentration obtained by using an existing test reagent that can cover the concentration range from a low value to a high value for examination (hereinafter referred to as "measured value ME"), the measured value M which is the concentration obtained by the medical examination apparatus 100 using only the first calibration curve, and the measured value M which is the concentration obtained by switching between the first calibration curve and the second calibration curve are compared. In FIG. 12, the measured value M1 is shown on the vertical axis, and the measured value M obtained by the medical examination apparatus 100 is shown on the horizontal axis. And in FIG. 12, the unit of the measured value of the concentration is set to [ng / ml]. In FIG. 12, the measured value ME is shown as a straight line S as the measured value that should originally be obtained.

[0070] As shown in Fig. 12(a), the measured value M obtained using only the first calibration curve (hereinafter referred to as "measured value M1") has a large variation with respect to the straight line S represented by the following formula (1) (hereinafter referred to as "straight line S1"), which should be originally obtained. Therefore, the correlation coefficient R between the straight line S1 (measured value ME) and the measured value M1 2 is given by the following formula (2).

[0071] y = 0.3787x + 82.664 ···(1)

[0072] R 2 = 0.5375 ···(2)

[0073] On the other hand, as shown in Fig. 12(b), the measured value M obtained using the first calibration curve and the second calibration curve (hereinafter referred to as "measured value M2") has a smaller variation with respect to the straight line S represented by the following formula (3) (hereinafter referred to as "straight line S2"), which should be originally obtained. Therefore, the correlation coefficient R between the straight line S2 (measured value ME) and the measured value M2 2 is given by the following formula (4), and shows a better correlation with the measured value ME than the measured value M1 obtained using only the first calibration curve.

[0074] y = 1.3465x + 27.972 ···(3)

[0075] R 2 = 0.9548 ···(4)

[0076] From this, it can be seen that in the medical examination device 100, for example, even when using a test reagent that could conventionally be used for testing specimens (test subjects) with low concentrations but not for those with high concentrations, it is possible to obtain a measured value M equivalent to the measured value (measured value ME) obtained using an existing test reagent that can cover a concentration range from low to high and perform the test. If the measured value M2 is set to the same value as the measured value ME, it can be achieved by correcting each value of the measured value M2, or in other words, by re-setting the reference value when measuring the measured value M. More specifically, it can be achieved by dividing each value of the measured value M2 by the value (=1.3465) of the first term on the right side of the above formula (3) representing the straight line S2.

[0077] In the medical examination device 100 with the above-described configuration, it has been described that the switching point for each of the first calibration curve and the second calibration curve is set by the user performing an input operation on an input interface (not shown). However, the setting of the switching point for each of the first calibration curve and the second calibration curve may be automatically performed in the medical examination device 100. For example, after the first calibration curve creation function 1442 creates the first calibration curve and the second calibration curve creation function 1444 creates the second calibration curve, the calibration curve creation function 144 (which may be a switching point setting function not shown) may confirm the slope of the first calibration curve and automatically set the position (point) where the slope of the first calibration curve becomes equal to or less than a predetermined threshold value (the slope becomes gentle) as the switching point. At this time, the calibration curve creation function 144 (which may be a switching point setting function not shown) may automatically set the switching point in consideration of the resolution of the test represented by the first calibration curve.

[0078] Also, in the medical inspection apparatus 100 having the above-described configuration, the calibration curve switching function 1462 has been described as switching the calibration curve used by the conversion function 146 when converting absorbance to concentration, based on the amount of change in absorbance output by the conversion function 146 and the maximum value of the amount of change in absorbance. However, the configuration may be such that the calibration curve used by the conversion function 146 when converting absorbance to concentration is switched between the first calibration curve and the second calibration curve based on at least one of the amount of change in absorbance and the maximum value of the amount of change in absorbance. For example, when the amount of change in absorbance is smaller than a predetermined threshold value, it may be switched to the first calibration curve, and when the amount of change in absorbance is larger than a predetermined threshold value, it may be switched to the second calibration curve. Alternatively, when the maximum value of the amount of change in absorbance is larger than a predetermined threshold value, it may be switched to the second calibration curve, and when the amount of change in absorbance is smaller than a predetermined threshold value, it may be switched to the first calibration curve. In such a configuration, it is sufficient to obtain in advance only the one used for switching the calibration curve among the amount of change in absorbance and its maximum value, and it is not always necessary to obtain the other before switching the calibration curve.

[0079] Furthermore, the medical inspection apparatus 100 having the above-described configuration has been described as using a calibration curve by the rate method as the first calibration curve, but the embodiment is not limited to this. For example, a calibration curve by the so-called endpoint method based on the difference in absorbance before and after the reaction may be used as the first calibration curve.

[0080] (Second Embodiment) Here, in the medical examination apparatus 100, an example of a method for automatically setting switching points for each of the first calibration curve and the second calibration curve will be described as a second embodiment. In the following description, it is assumed that a switching point setting function (hereinafter referred to as "switching point setting function 1446") (not shown) provided in the calibration curve creation function 144 automatically sets the switching point between the first calibration curve and the second calibration curve. And since the configuration of the medical examination apparatus 100 according to the second embodiment is a configuration in which the switching point setting function 1446 is added to the calibration curve creation function 144 in the processing circuit 140 included in the medical examination apparatus 100 according to the first embodiment shown in FIG. 1, detailed descriptions regarding the configuration and functional configuration of the medical examination apparatus 100 according to the second embodiment will be omitted.

[0081] When the judgment formula (inequality) represented by the following formula (5) does not hold, the switching point setting function 1446 determines that the absorbance cannot be converted into concentration using the first calibration curve, that is, the absorbance is converted into concentration using the second calibration curve.

[0082] (α - β) / MU < (RATE(α) - RATE(β)) / DR ···(5)

[0083] In the above formula (5), MU is the minimum measurement unit in the medical examination apparatus 100. The minimum measurement unit MU is a numerical value determined as a product specification of the medical examination apparatus 100. For example, when the medical examination apparatus 100 can measure the concentration of the test subject in units of "1" but cannot measure it in units of "0.5", the minimum measurement unit MU is "1".

[0084] In the above formula (5), α and β are codes for distinguishing standard samples. And RATE(α) is the change in absorbance of standard sample α (change amount RATE(m)), and RATE(β) is the change in absorbance of standard sample β (change amount RATE(m)). When standard sample α is a standard sample of system 4 showing characteristics as shown in FIG. 2 (a standard sample with a known concentration of 6010 [U / L]), referring to the first calibration curve shown in FIGS. 5(a) to 9(a), the change amount RATE(α) = 0.089 [A.U. / s]. When standard sample β is a standard sample of system 3 showing characteristics as shown in FIG. 2 (a standard sample with a known concentration of 3090 [U / L]), referring to the first calibration curve shown in FIGS. 5(a) to 9(a), the change amount RATE(β) = 0.083 [A.U. / s].

[0085] In the above formula (5), DR is a value representing the performance of the medical inspection device 100. This performance represents, for example, the resolution of the detector, the dynamic range, and the performance of how much difference in absorbance can be distinguished, and is a numerical value determined by the performance of the measurement unit 120 provided in the medical inspection device 100. In the following description, for example, DR = 0.00001 is set.

[0086] In this case, the left side in the above formula (5) becomes as shown in the following formula (6), and the right side becomes as shown in the following formula (7).

[0087] (α - β) / MU = (6010 - 3090) / 1 = 2,920 ···(6)

[0088] (RATE(α) - RATE(β)) / DR =(0.089 - 0.083) / 0.00001 = 600 ···(7)

[0089] Therefore, between the standard sample α of system 4 and the standard sample β of system 3, the inequality in the above formula (5) does not hold. For this reason, the switching point setting function 1446 determines that there is no switching point between the standard sample α of system 4 and the standard sample β of system 3.

[0090] In this case, the switching point setting function 1446 sets the combination of the standard sample α and the standard sample β to the following combination. For example, the standard sample α is set as the standard sample of system 3 (standard sample with a known concentration of 3090 [U / L]), and the standard sample β is set as the standard sample of system 2 (standard sample with a known concentration of 1020 [U / L]). Then, the switching point setting function 1446 similarly determines whether the inequality in the above formula (5) holds for this combination of the standard sample α and the standard sample β. When it is determined that the inequality in the above formula (5) holds, the switching point setting function 1446 sets any value within the range of the first calibration curve in the combination of the standard sample α and the standard sample β at this time as the cut-off value A and sets it as the switching point.

[0091] On the other hand, in the above example, in the combination of the standard sample α of system 4 and the standard sample β of system 3, the inequality in the above formula (5) did not hold. However, if the inequality in the above formula (5) holds in the combination of the standard sample α of system 4 and the standard sample β of system 3, the switching point setting function 1446 determines that there is no switching point for switching between the first calibration curve and the second calibration curve. That is, the switching point setting function determines that the absorbance can be converted into concentration using only the first calibration curve and that the absorbance is not converted into concentration using the second calibration curve.

[0092] In this way, in the medical examination apparatus 100 of the second embodiment, the switching point setting function 1446 in the calibration curve creation function 144 provided in the processing circuit 140 automatically sets in advance the switching point between the first calibration curve and the second calibration curve created prior to actually performing the examination of the specimen in the medical examination apparatus 100. And also in the medical examination apparatus 100 of the second embodiment, similar to the medical examination apparatus 100 of the first embodiment, each of the first calibration curve and the second calibration curve is stored in the storage unit 160 in association with the set switching point. Thereby, also in the medical examination apparatus 100 of the second embodiment, similar to the medical examination apparatus 100 of the first embodiment, for example, even when using a test reagent that can conventionally be used for examining a specimen (test object) with a low concentration but cannot be used for examining a specimen (test object) with a high concentration, the examination of the specimen (test object) can be performed more accurately. And also in the medical examination apparatus 100 of the second embodiment, similar to the medical examination apparatus 100 of the first embodiment, when actually performing the examination of the specimen, the absorbance output by the measurement unit 120 is converted into a concentration using the first calibration curve or / and the second calibration curve, and presented to the user as a measurement value obtained by examining the specimen (test object). Thereby, a user who uses the medical examination apparatus 100 of the second embodiment can confirm a more accurate examination result of the specimen (test object), similar to a user who uses the medical examination apparatus 100 of the first embodiment.

[0093] As described above, in the medical examination apparatus of the embodiment, prior to actually performing the examination of the specimen, based on the absorbance output by the measurement unit, each of the first calibration curve and the second calibration curve is created and stored in the storage unit. Thereby, in the medical examination apparatus of the embodiment, for example, even when using a test reagent that can conventionally be used for examining a specimen (test object) with a low concentration but cannot be used for examining a specimen (test object) with a high concentration, the examination of the specimen (test object) can be performed more accurately.

[0094] In the above-described embodiment, the case where the processing circuit included in the medical inspection device is realized in one computer device or a server device on a network (not shown) is taken as an example for explanation. However, this is merely an example, and the processing circuit included in the medical inspection device, or the functions realized by the processing circuit included in the medical inspection device, may be realized by a configuration combining a plurality of server devices and computer devices. In this case, the functional configuration, operations, and processes of the processing circuit included in the medical inspection device may be made equivalent to the functional configuration, operations, and processes of the processing circuit included in the medical inspection device of the above-described embodiment. Therefore, detailed descriptions regarding the processing circuit included in the medical inspection device in this case, or the functional configuration, operations, and processes in which its functions are realized, are omitted.

[0095] The above-described embodiment can be expressed as follows. Comprising a processing circuitry, The processing circuitry creates a first calibration curve based on a first absorbance output by a measuring instrument that measures by mixing a test reagent with a standard sample of known concentration, creates a second calibration curve based on a change rate of the first absorbance, uses the first calibration curve and / or the second calibration curve to output a measured value obtained by converting a second absorbance output by the measuring instrument that measures by mixing the test reagent with a specimen into the concentration of a component contained in the specimen, Medical inspection device.

[0096] According to at least one embodiment described above, a first calibration curve creation unit (1442) that creates a first calibration curve based on a first absorbance output by a measuring instrument (120) that measures by mixing an inspection reagent with a standard sample having a known concentration, a second calibration curve creation unit (1444) that creates a second calibration curve based on a change rate of the first absorbance, and using the first calibration curve or / and the second calibration curve, a conversion unit (146) that outputs a measured value obtained by converting a second absorbance output by the measuring instrument that measures by mixing the inspection reagent with a specimen into the concentration of a component contained in the specimen, whereby it is possible to create a calibration curve that covers a range from a low concentration to a high concentration and quantifies, and a medical inspection apparatus, a medical inspection method, a calibration curve creation method, and a program that can convert into a measured value representing the concentration of a component contained in a specimen based on the measured absorbance can be realized.

[0097] Although several embodiments have been described, these embodiments are presented by way of example and are not intended to limit the scope of the invention. These embodiments can be implemented in various other forms, and various omissions, replacements, and changes can be made without departing from the gist of the invention. These embodiments and their modifications are included in the scope and gist of the invention, and are also included in the invention described in the claims and the equivalent scope thereof.

Explanation of Reference Numerals

[0098] 100... medical inspection apparatus, 120... measurement unit, 140... processing circuit, 142... acquisition function, 144... calibration curve creation function, 1442... first calibration curve creation function, 1444... second calibration curve creation function, 146... conversion function, 1462... calibration curve switching function, 148... measured value output function, 160... storage unit

Claims

1. A first calibration curve creation unit that creates a first calibration curve based on a first absorbance output by a measuring instrument obtained by mixing an inspection reagent with a standard sample having a known concentration and measuring the mixture; A second calibration curve creation unit that creates a second calibration curve based on a change rate of the first absorbance; A conversion unit that outputs a measured value obtained by converting a second absorbance output by the measuring instrument obtained by mixing the inspection reagent with a specimen and measuring the mixture into a concentration of a component contained in the specimen by using the first calibration curve and / or the second calibration curve; A medical inspection apparatus comprising the above components.

2. The second calibration curve creation unit creates the second calibration curve based on a maximum value of a first absorbance change amount representing a change amount per unit time of the first absorbance. The medical inspection apparatus according to Claim 1.

3. The first calibration curve creation unit creates the first calibration curve based on the first absorbance change amount. The medical inspection apparatus according to Claim 2.

4. The second calibration curve creation unit obtains the maximum value of the first absorbance change amount by differentiating the first absorbance change amount, and creates the second calibration curve. The medical inspection apparatus according to Claim 3.

5. The conversion unit includes a calibration curve switching unit that switches a calibration curve used when converting the second absorbance into the concentration to the first calibration curve and / or the second calibration curve. The medical inspection apparatus according to any one of Claims 2 to 4.

6. Each of the first calibration curve and the second calibration curve has a switching point set in advance. The conversion unit obtains a second absorbance change amount representing a change amount per unit time of the second absorbance and a maximum value of the second absorbance change amount. The calibration curve switching unit switches a calibration curve used when converting the second absorbance into the concentration based on the second absorbance change amount and the maximum value of the second absorbance change amount. The conversion unit converts the second absorbance into the concentration by using the switched first calibration curve and / or the second calibration curve. The medical inspection apparatus according to Claim 5.

7. The calibration curve switching unit A first selection condition that the second absorbance change amount is equal to or less than a first cut-off value determined by the switching point preset in the first calibration curve; A second selection condition that the maximum value of the second absorbance change amount is greater than a second cut-off value determined by the switching point preset in the second calibration curve; ​ Based on this, switch the calibration curve used when converting the second absorbance to the concentration. The medical examination device according to claim 6.

8. When the change amount of the second absorbance satisfies the first selection condition and the maximum value of the change amount of the second absorbance does not satisfy the second selection condition, the calibration curve used when converting the second absorbance to the concentration is switched to the first calibration curve. The medical examination device according to claim 7.

9. When the change amount of the second absorbance does not satisfy the first selection condition and the maximum value of the change amount of the second absorbance satisfies the second selection condition, the calibration curve used when converting the second absorbance to the concentration is switched to the second calibration curve. The medical examination device according to claim 7.

10. When the change amount of the second absorbance satisfies the first selection condition and the maximum value of the change amount of the second absorbance satisfies the second selection condition, the calibration curve used when converting the second absorbance to the concentration is switched to the first calibration curve. The medical examination device according to claim 7.

11. When the change amount of the second absorbance does not satisfy the first selection condition and the maximum value of the change amount of the second absorbance does not satisfy the second selection condition, the calibration curve used when converting the second absorbance to the concentration is switched to the first calibration curve. The medical examination device according to claim 7.

12. When the change amount of the second absorbance satisfies the first selection condition and the maximum value of the change amount of the second absorbance satisfies the second selection condition, the calibration curve used when converting the second absorbance to the concentration is switched to both the first calibration curve and the second calibration curve. The medical examination device according to claim 7.

13. The conversion unit uses the average value of the first concentration, which is the concentration obtained by converting the second absorbance using the first calibration curve, and the second concentration, which is the concentration obtained by converting the second absorbance using the second calibration curve, as the concentration obtained by converting the second absorbance. The medical examination device according to claim 12.

14. When the calibration curve switching unit determines that the second absorbance change amount does not satisfy the first selection condition and the maximum value of the second absorbance change amount does not satisfy the second selection condition, the calibration curve used for converting the second absorbance into the concentration is switched to both the first calibration curve and the second calibration curve. The medical examination device according to claim 7.

15. The conversion unit sets, as the concentration obtained by converting the second absorbance, the average value between a first concentration, which is the concentration obtained by converting the second absorbance using the first calibration curve, and a second concentration, which is the concentration obtained by converting the second absorbance using the second calibration curve. The medical examination device according to claim 14.

16. When the maximum value of the second absorbance change amount obtained when the conversion unit converts the second absorbance into the concentration using the second calibration curve exceeds the concentration range represented by the second calibration curve, the conversion unit sets, as the concentration obtained by converting the second absorbance, the concentration corresponding to the maximum value of the second absorbance change amount estimated based on the second calibration curve. The medical examination device according to claim 7.

17. When the second absorbance change amount obtained when the conversion unit converts the second absorbance into the concentration using the first calibration curve intersects the first delimiter value at a plurality of locations on the first calibration curve, the conversion unit sets, as the concentration obtained by converting the second absorbance, the lower of the plurality of concentrations obtained from the first calibration curve. The medical examination device according to claim 16.

18. A switching point is set in advance for at least one of the first calibration curve and the second calibration curve. The conversion unit obtains at least one of a second absorbance change amount representing the change amount of the second absorbance per unit time and the maximum value of the second absorbance change amount. Based on at least one of the second absorbance change amount and the maximum value of the second absorbance change amount, the calibration curve switching unit switches the calibration curve used for converting the second absorbance into the concentration. The conversion unit converts the second absorbance into the concentration using the switched first calibration curve and / or the second calibration curve. The medical examination device according to claim 5.

19. A computer creates a first calibration curve based on a first absorbance output by a measuring instrument that measures a test reagent mixed with a standard sample having a known concentration, and creates a second calibration curve based on the change rate of the first absorbance. Using the first calibration curve and / or the second calibration curve, output a measured value obtained by converting the second absorbance output by the measuring instrument, which measured the test reagent mixed with the sample, into the concentration of the component contained in the sample. Medical examination method.

20. A computer creates a second calibration curve for converting the second absorbance output by the measuring instrument, which measured the test reagent mixed with the sample, into the concentration of the component contained in the sample, based on the maximum value of the first absorbance change amount representing the change amount per unit time of the first absorbance output by the measuring instrument that measured the test reagent mixed with a standard sample with a known concentration. Calibration curve creation method.

21. On a computer cause the creation of a first calibration curve based on the first absorbance output by the measuring instrument that measured the test reagent mixed with a standard sample with a known concentration, cause the creation of a second calibration curve based on the change rate of the first absorbance, and using the first calibration curve and / or the second calibration curve, output a measured value obtained by converting the second absorbance output by the measuring instrument, which measured the test reagent mixed with the sample, into the concentration of the component contained in the sample. Program.

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