JPH09292387A - Method and apparatus for measuring amount of component to be measured - Google Patents

Abstract

PROBLEM TO BE SOLVED: To more accurately determine the amount of a component to be measured from a measured physical quantity. SOLUTION: After the reaction is made between a sample to be measured and a reagent, the amount of a component to be measured contained in the sample to be measured is determined, based on a measured value obtained using the sample. In this case, a table indicating a corresponding relationship between a preset value and a corresponding amount of a component primarily corresponding to a set value in the component to be measured is prepared beforehand, and the amount of the component to be measured is derived regarding the measured value based on the table (S6).

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention uses a method for measuring the amount of a component to be measured when the amount of the component to be measured contained in the sample to be measured is measured using the sample to be measured. Regarding measuring device. In particular, the present invention is used in the medical field for the measurement of the amount of components of the components to be measured contained in biological fluids such as blood and urine, and further the so-called dry chemistry is applied to measure the amount of components of the components to be measured. The present invention relates to a measuring method and a measuring device for measuring an amount of a component to be measured used in performing

[0002]

2. Description of the Related Art As a sample to be measured, a biological fluid in the field of biochemistry such as blood and urine will be described as an example. There is an apparatus that measures the concentration of a component to be measured, for example, a sugar component, that is, glucose, contained in the biological fluid using the biological fluid. As an example of such an apparatus, there is an apparatus that measures the amount of the component to be measured contained in the biological fluid by utilizing a so-called dry chemistry in which a dried reagent and a sample to be measured are reacted. What is shown in FIG. 9 is a test piece 130 set in such a measuring device 140.
The test piece 130 corresponds to the liquid sample analysis tool disclosed in Japanese Patent Application Laid-Open No. 4-188065 filed by the applicant of the present application. Back surface 13 of test piece 130
A through hole 134 is formed in the support 133 attached to the No. 2 and the reaction part 135 including the reagent layer made of the reagent using the above-mentioned dry chemistry is provided in the through hole 134.
And is attached to the support 133. Further, a sample supply hole 136 and an air discharge hole 137 are formed on the surface 131 side of the test piece 130, and the sample supply hole 136 and the air discharge hole 137 are communicated with each other through a capillary chamber 138. The reaction part 135 is arranged substantially at the center of the length of the capillary chamber 138.

On the other hand, as shown in FIG. 10, the measuring device 140 on which the test piece 130 is set has an LED (light emitting diode) 141 for concentration measurement and an LE for spotting detection.
D142, a light receiving photodetector 143, a correcting photodetector 144, and a light branching glass plate 145. The concentration measuring LED 141 is also used to confirm whether or not the test piece 130 has been used.
42 is also used to detect the presence or absence of the test strip 130.

Such a test piece 130 and a measuring device 140
In the case where blood glucose, that is, glucose is taken as an example of the component to be measured, the blood as the sample to be measured is spotted in the sample supply hole 136, so that the spotted blood is stored in the capillary chamber 138. It permeates in the direction of the air discharge hole 137 by a capillary phenomenon. Therefore, the spotted blood reaches the reaction part 135, and the reaction between glucose in the blood and the reagent in the reagent layer occurs. The above reagent contains glucose oxidase and peroxidase, and the reaction part 135
Has a yellow color before the reaction. Glucose in blood is oxidized by the glucose oxidase.
Therefore, gluconic acid and hydrogen peroxide are produced in the reaction section 135. The produced hydrogen peroxide produces a blue-green quinone dye by the above peroxidase. In this way, the reaction portion 135 changes its hue from yellow before the reaction to blue-green after the reaction. The amount of the generated quinone dye is emitted from the concentration measuring LED 141 and is emitted from the reaction unit 13
The light reflected at 5 is received by the light-receiving photodetector 143, the reflectance is obtained based on the output voltage of the detector 143, and the glucose concentration is measured based on the reflectance.

In the above dry chemistry, since the reagent is in a dry state, it is not necessary to adjust the reagent like a liquid reagent, ii) stable for a relatively long period of time, ii
i) small storage space for reagents, iv) easy handling of reagents, v) easy measurement operation, v
i) The feature is that the amount of sample to be measured is small. Due to these characteristics, dry chemistry is often used for emergency tests, pre-examination tests (screening), personal items, and the like.

[0006]

The measuring device 14 described above is used.
At 0, as described above, measuring the glucose concentration in blood directly from the reflectance due to the change in the hue of the reaction part 135 causes a large measurement error. Therefore, the glucose concentration is calculated from the reflectance using the K / S function using the item “K / S” calculated in advance based on the predetermined reflectance. The relationship between the value obtained by the above K / S function (hereinafter referred to as “K / S function value”) and the concentration is shown in FIG.
Since it is represented by a calibration curve such as a linear function as shown in (1), it is actually an equation calculated based on the calibration curve for the measured reflectance and stored in the measuring device 140. The glucose concentration is measured using the conversion formula. The above K / S is the ratio of the absorption coefficient and the scattering coefficient in the absorbing / scattering body, and is obtained by the Kubelka-Munk equation. As shown in FIG. 8, the calibration curve 150 has a plurality of known glucose concentrations and their respective glucose concentrations in advance on the Cartesian coordinates in which the horizontal axis represents the concentration value and the vertical axis represents the K / S function value. The intersections 151 with the above K / S function values obtained based on the respective measured reflectances are sequentially described, and a linear line created by using, for example, the least squares method based on the plurality of intersections 151. , Or a cubic curve (not shown in FIG. 8). Such a calibration curve 1
The conversion formula of the linear or cubic formula is calculated from 50, and the data related to the conversion formula is stored in the measuring device 140 in advance. From the properties of the calibration curve 150, all the relationships between the glucose concentration in the sample to be measured and the K / S function value obtained from the reflectance are expressed by the conversion formula based on the calibration curve 150. There is no match. Further, when the concentration value is calculated based on the above conversion formula, the value at which the true concentration value starts to deviate greatly from the converted concentration value obtained by the above conversion formula, that is, the values corresponding to the reference numerals 152 and 153 are It becomes the detection limit value. The detection limit value greatly varies depending on the component to be measured and the physical property to be measured. For example, in the case of glucose described above, when the physical property is voltage, the true concentration value deviates from the converted concentration value by about ± 15%. Is. Especially when using the above-mentioned dry chemistry,
The relationship between the K / S function value and the concentration of the measured component is often non-linear. Therefore, in the method of converting using the calibration curve, the K / S function value and the concentration of the measured component are The range in which the relationship has linearity, that is, the range 154 with high measurement accuracy is narrowed.

In the above description, the case where dry chemistry is used as a reagent and the relationship between the K / S function value obtained from the reflectance and the glucose concentration is taken as an example. The component to be measured is not limited to glucose, and the measured value of a certain physical property to be measured is not limited to the above-mentioned reflectance, but may be light transmittance, conductivity, electromotive force, or the like. The above-mentioned calibration curve is used even when the component amount of the component to be measured is measured from such a measured value, and there is a problem as described above. The present invention has been made in order to solve the above-mentioned problems, and it is possible to more accurately determine the component amount of the component to be measured from the measured value. It is an object of the present invention to provide a measuring device that

[0008]

Means for Solving the Problems and Their Actions First of the Invention
The measurement method according to the embodiment is a method of obtaining the amount of a component to be measured of the component to be measured contained in the sample to be measured based on a measured value in a certain physical property measured using a sample after reaction in which a sample to be measured and a reagent are reacted In the method, the measured component amount for the measured value is a preset value in the same physical property as the physical property in the measured value, and the corresponding component amount uniquely corresponding to the set value in the measured component. It is characterized in that it is derived based on a table showing the correspondence relationship with.

The measuring method according to the second aspect of the present invention is
In order to obtain the measured component amount of the measured component contained in the measured sample based on the measured value in a certain physical property measured using the reaction sample after reacting the measured sample and the reagent,
A calibration curve is obtained in advance based on a plurality of known component amounts in the measured component contained in the measured sample and a plurality of known measured values corresponding to the known component amounts, and the calibration curve for the measured values is obtained. A measurement method for obtaining the amount of the component to be measured based on the above, when the measured value is included in the convertible range in which the amount of the component to be measured can be obtained based on the calibration curve If the measured value is included in the conversion prohibited range in which the measured component amount is determined based on the calibration curve and the measured component amount cannot be determined based on the calibration curve, the preset setting is the same as the physical property of the measured value. And the measured component for the measured value based on a table showing the correspondence relationship between the value and the corresponding component amount that uniquely corresponds to the set value in the measured component. Characterized in that derive.

The measuring device according to the third aspect of the present invention is
Of the measured component amount for obtaining the measured component amount of the measured component contained in the measured sample based on the measured value in a certain physical property measured by using the post-reaction sample obtained by reacting the measured sample with a reagent A measuring device using a measuring method,
The measured component amount for the measured value is a preset value in the same physical property as the physical property in the measured value, and the corresponding relationship between the corresponding component amount that uniquely corresponds to the set value in the measured component. It is characterized in that it is derived based on the table shown.

The measuring device according to the fourth aspect of the present invention is
Of the measured component amount for obtaining the measured component amount of the measured component contained in the measured sample based on the measured value in a certain physical property measured by using the post-reaction sample obtained by reacting the measured sample with a reagent A measuring device using a measuring method,
A memory that stores a table showing a correspondence relationship between a preset value in the same physical property as the measured value and a corresponding component amount that uniquely corresponds to the set value in the measured component, and the measured value And component amount deriving means for reading the corresponding component amount corresponding to the measured value from the memory.

The measuring apparatus according to the fifth aspect of the present invention is
In order to obtain the measured component amount of the measured component contained in the measured sample based on the measured value in a certain physical property measured using the reaction sample after reacting the measured sample and the reagent,
A calibration curve is obtained in advance based on a plurality of known component amounts in the measured component contained in the measured sample and a plurality of known measured values corresponding to the known component amounts, and the calibration curve for the measured values is obtained. A measurement device that uses a measurement method for determining the measured component amount based on the above, when the measured value is included in the convertible range in which the measured component amount can be calculated based on the calibration curve Is the same as the physical property in the measured value when the measured value is included in the conversion prohibited range in which the measured component amount cannot be calculated based on the calibration curve. In the above-mentioned measured value based on the table showing the correspondence relationship between the preset value and the corresponding component amount that uniquely corresponds to the preset value in the measured component. That wherein the deriving the measuring component amount.

The measuring device according to the sixth aspect of the present invention is
In order to obtain the measured component amount of the measured component contained in the measured sample based on the measured value in a certain physical property measured using the reaction sample after reacting the measured sample and the reagent,
A calibration curve is obtained in advance based on a plurality of known component amounts in the measured component contained in the measured sample and a plurality of known measured values corresponding to the known component amounts, and the calibration curve for the measured values is obtained. A measurement device that uses a measurement method for determining the amount of the component to be measured based on, with preset values set in the same physical properties as the measured values,
In the measured component, a table representing the correspondence relationship with the corresponding component amount that uniquely corresponds to the set value, a memory that stores information that represents the calibration curve, and the measured value is supplied, the supplied measurement Judgment means for judging whether or not the value is included in the convertible range capable of obtaining the measured component amount based on the calibration curve, and electrically connected to the judgment means, and the measurement is performed by the judgment means. When it is determined that the value falls within the convertible range, the measured component amount is obtained based on the information representing the calibration curve stored in the memory for the measured value, while the determination unit determines the measured value. When it is determined that the value falls within the conversion prohibited range where the measured component amount cannot be obtained based on the calibration curve, the measured value is based on the table stored in the memory. Characterized in that and a component amount deriving means for obtaining the measured component amount.

The measuring method according to the first aspect, and the third method
And the measuring device according to the fourth aspect derives the measured component amount based on the previously created correspondence relationship between the set value and the corresponding component amount for the measured value without using the calibration curve, and thus the conventional calibration method is used. When the measured component amount is obtained by line conversion, the measured component amount is obtained with high accuracy even in the range where the difference between the component amount obtained by conversion and the true component amount is large and the measurement accuracy deteriorates. Acts like.

Further, in the measuring method according to the second aspect and the measuring apparatus according to the fifth and sixth aspects, even when the amount of the component to be measured is obtained by the conversion by the calibration curve, the component obtained by the conversion is calculated. For the convertible range in which the difference between the amount and the true component amount is small and the measurement accuracy is good, the measured component amount is obtained using a calibration curve as in the conventional method. On the other hand, in the conversion prohibited range in which the measurement accuracy is deteriorated by the conversion using the calibration curve, the measured component amount is derived based on the previously created correspondence between the set value and the corresponding component amount. As described above, the measuring method according to the second aspect and the measuring apparatuses according to the fifth and sixth aspects act so as to obtain the amount of the component to be measured with high accuracy in the entire measurement range.

[0016]

BEST MODE FOR CARRYING OUT THE INVENTION A method for measuring the amount of a component to be measured, which is an embodiment of the present invention, will be described below with reference to the drawings and tables. A measuring device according to another embodiment of the present invention is a device that functions by using the above measuring method. Further, as the sample to be measured used in these embodiments, any liquid, gas or the like can be used, for example, biological fluid can be used, and specifically blood, urine or the like can be used. . The reagent reacts with the sample to be measured in order to obtain the amount of the component to be measured contained in the sample to be measured, and a liquid or dried reagent can be used. In this embodiment, a case where a dry reagent type is used, which is so-called dry chemistry, is used as an example. Further, the measurement value is required by the measurer, for example, in order to provide the component amount, the reflectance of light obtained from the reaction sample after reacting the sample to be measured and the reagent, the transmittance of light, It is a value in physical properties such as conductivity and electromotive force. As the above-mentioned measurement value, for example, the reflected light in the reaction part 135 of the test piece 130 as described above is detected by the photodetector 14
3 corresponds to the voltage value or reflectance obtained by receiving light at 3, or the voltage value or current value obtained from the electrode for the post-reaction sample. Further, as will be described later, a “table” is created, so that among the above-mentioned physical properties, preset values are used as set values.

In the measurement method, first, the set value and a corresponding component amount that is a value that uniquely corresponds to the set value and that is the measured value of the measured component amount that corresponds to the set value. A table showing a correspondence relationship with is created in the form of a so-called table. A specific example of this table will be shown in an embodiment described later. In addition, for example, each value of “voltage value” described in Table 1 corresponds to the set value, and each value of “concentration” in the column of “table conversion” corresponds to the corresponding component amount. or,
The voltage values in Table 1 are output from the photodetector 143 based on the reflectance of light in the reaction section 135 as described above. In addition, the collection of each data described in the table is usually obtained from the measured value, that is, the set value, and the measured value of the sample to be measured whose component amount is known in advance, that is, the true concentration value, as described later. By determining the corresponding component amount, the correspondence between the corresponding component amount and the set value is examined.

In the present embodiment, the amount of component to be measured is obtained by referring to the above table. For example, in the case of measuring the glucose concentration by the voltage obtained by reflected light, refer to Table 1. If the measured value is 34.8 mV, it corresponds to “34.8 mV” of “voltage value”. The concentration value “75.5 mg / dl” is derived. Further, when the measured value is a value not described in the table, for example, when the measured value is 32.0 mV in Table 1, the set values “34.8 mV” and 30.7 mV "and" concentration values "of" 75.5 mg / dl "and" 98.6 mg / d ", respectively.
Based on “1”, for example, interpolation calculation is performed, and the above 3
A concentration value corresponding to 2.0 mV can be obtained.
The setting intervals of the above-mentioned set values are determined empirically corresponding to each measured component.

The table can be created over the entire measuring range required by the measurer, but in consideration of the capacity of the memory for storing the data of the table, the above-mentioned method is used when determining the amount of the component to be measured. Calibration curve,
You may use together with the said table. That is, when the measured value is included in the convertible range in which the measured component amount can be converted based on the calibration curve described above, for example, the range 154 with high measurement accuracy shown in FIG. 8, the measured component amount is calculated using the calibration curve. On the other hand, on the other hand, if the measured component amount is converted based on the calibration curve, a conversion prohibited range in which the error between the value obtained by the conversion and the true component amount becomes large, for example, range 15 shown in FIG.
When the measured values are included in 5, 156, a table may be used to derive the measured component amount. In such a combined type, the convertible range is determined in advance for each component to be measured, and a table is created for the conversion prohibited range. Therefore, by storing the data related to the table of the above-mentioned conversion prohibited range in the memory, it is possible to prevent the storage capacity of the memory from increasing.

Regarding the correspondence between each set value and the value of the corresponding component amount corresponding to the set value, a sample to be measured having a known component amount, in other words, a measured component whose true component amount is known in advance is usually used. Using a sample, the measured value measured using the sample to be measured is a set value, and the component amount obtained based on the measured value is the corresponding component amount, and each set value and the corresponding component corresponding to the set value. The correspondence with the quantity value is determined. still,
The set value and corresponding component amount for one true component amount may be measured only once, but an error may occur when adjusting the true component amount, and there is a measurement error between the measured value and the corresponding component amount. Therefore, the measurement is performed a plurality of times, the average value of the plurality of measurement values obtained from these is set, and the average value of the plurality of component amounts obtained based on the plurality of measurement values is the corresponding component amount. Preferably. Incidentally, the method of determining the set value and the corresponding component amount from the plurality of measured values and component amounts is not limited to the method of taking the above-mentioned simple average, for example,
Known methods such as weighted average and rolling average can be used. For example, when taking a rolling average of the measured values, as shown in FIG. 5, the relationship between the true component amount and the measured values is calculated in advance as much as possible over the measuring range.
An average value 22 of a plurality of measurement values included in the area 20 having the measurement range is set as a measurement value corresponding to the true component amount 21 at the center of the area 20, in other words, a set value, and then the area 2
In an area smaller than 0, for example, by one digit, an average value 25 of a plurality of measurement values included in the area 23 moved from the area 20 is measured to correspond to the true component amount 24 at the center of the area 23. As a value (set value), the relationship between the true component amount and the set value may be sequentially determined in this manner. Average value of the measured values obtained by such a method 22,
25 is not the average value in the population independent of each other,
Since it is the average value of the mutually related population, the measured component amount derived using such average values 22 and 25 can have higher measurement accuracy.

Further, particularly when the reagent uses dry chemistry, the reagent has a manufacturing error of the reagent, for example, an error generated in units of manufacturing lots, an error generated by a manufacturing line, and the like. Therefore, as is conventionally done, for example, the test piece 130 as shown in FIG. 9 shows information indicating the manufacturing error of the reagent applied to the reaction part 135. Therefore, in order to deal with such conventional measures, a plurality of types of tables showing the correspondence relationship between the set values and the corresponding component amounts are also created in the present embodiment in response to the manufacturing error. , A table corresponding to the information indicating the manufacturing error is selected and used.

The data relating to the table described above is
It is stored in, for example, a semiconductor memory provided in the measuring device for measuring the amount of component to be measured. The configuration of the measuring device will be described below with reference to the drawings. The measuring device 210 shown in FIG. 6 is a device corresponding to the case where the above table is created over the entire measuring range required by the measurer, and is the measuring means 1 and the measuring means 1.
The arithmetic unit 2 and the control unit 3 electrically connected to the display unit 4 and the display unit 4 electrically connected to the arithmetic unit 2 and the control unit 3.
And a memory 205 electrically connected to the arithmetic unit 2. The arithmetic unit 2 includes a component amount deriving unit 206, and the measuring unit 1 is electrically connected to the component amount deriving unit 206. On the other hand, the measuring device 10 shown in FIG. 1 is a device that uses both the above-mentioned table and the above-mentioned calibration curve when deriving the measured component amount, and the computing device 2 is further provided with a judging means 200. When the determination unit 200 is provided, the component amount derivation unit 201 is provided instead of the component amount derivation unit 206. Further, as shown in FIG. 1, the measuring apparatus 10 includes a memory 5 instead of the memory 205. In the case of the measuring device 10, the judging means 200 is electrically connected to the measuring means 1 and the control section 3, and the component amount deriving means 201 is the judging means 2.
00, the control unit 3, the memory 5, and the display device 4 are electrically connected.

The portion containing the reagent 6 is provided in the measuring means 1 or mechanically connected to the measuring means 1. For example, in the measuring device 10 in which the amount of the component to be measured is measured based on the reflected light from the post-reaction sample, the measuring means 1 is a light source for projecting light onto the post-reaction sample, as shown in FIG. A light source 7 corresponding to the above-described concentration measuring LED 141, and a light receiving device for detecting the reflected light reflected from the sample after the light from the light source 7 has reacted, and the above-described light receiving photodetector 1
And a light receiving device 8 corresponding to 43. The output of the light receiving device 8 is electrically connected to the computing device 2 and the control unit 3.
Further, for example, when the reagent 6 is provided between the pair of electrodes, the electrode is mechanically and electrically connected to the measuring means 1, and the measuring means 1 is generated by the reaction between the reagent 6 and the sample to be measured. Measure the electromotive force corresponding to the measured value. Note that the following description of the configuration is a measuring apparatus in which the measurement is performed based on the voltage obtained corresponding to the reflected light in the sample after the reaction, and the measuring apparatus 10 is mainly taken as an example.

The control unit 3 uses, for example, the above-described test piece 130.
In response to the attachment / detachment to / from the measurement means 1, operation control such as turning on / off of the measuring device 10 and starting display on the display device 4 is performed. The memory 5 stores a table showing each value of “voltage value” shown in Table 1 and the like, and each value of “concentration” in the column of “table conversion”, and data forming a calibration curve. It should be noted that the memory 205 stores only the data of the table showing the respective values of the “voltage value” and the respective “density”. Component amount deriving means 20 in the arithmetic unit 2
1 reads out the measured component amount from the memory 5 based on the measured value supplied from the measuring means 1 according to the control of the control unit 3, and displays the measured component amount on the display device 4. As described above, when the table and the calibration curve are used in combination, the determination means 200 in the computing device 2 determines that the measured value supplied from the measurement means 1 is the amount of the component to be measured based on the calibration curve. Is included in the convertible range or is included in the conversion prohibited range. Based on the determination, the component amount deriving unit 201 displays the component amount to be measured by conversion using the calibration curve or the component amount to be measured read from the table on the display device 4. Also, the judging means 2
00 is determined through the control unit 3 when it is determined that the measured value supplied from the measuring means 1 is included in the convertible range or the prohibited range, and that the measured value is included in at least the prohibited range. It can also function so as to display that fact on the display device 4.

Before starting the measurement of the amount of component to be measured,
In order to select the table and the calibration curve corresponding to the manufacturing error of the reagent used for the measurement, the manufacturing error is confirmed in advance by the measuring means 1 for the reagent having the same manufacturing error as the reagent used for the measurement. Measure the measurement value for. The control unit 3 selects the table and the calibration curve based on the manufacturing error confirmation measurement value supplied from the measuring unit 1, and sends the selection information to the component amount deriving unit 201 in the arithmetic unit 2. . Therefore, the arithmetic unit 2 obtains the measured component amount by using the table selected based on the selection information or the table and the calibration curve when measuring the measured component amount.

The function of the judging means 200 is controlled by the control unit 3.
It is possible to delete the determination means 200 even in the measuring device that uses both the table and the calibration curve.

The operation of the measuring device 10 or the measuring device 210 configured as described above will be described below with reference to FIGS. 3 and 4. Further, FIG. 3 shows a case where the measured component amount is obtained using only the table in the measuring device 210.
In the measurement device 10, the case where the table and the calibration curve are used together to obtain the amount of the component to be measured is shown.

In FIG. 3, steps (“S” in the figure)
At 0), the table is selected according to the manufacturing error. In step 1, the test piece containing the reagent as described above is attached to the measuring device, in step 2, the sample to be measured is attached to the reagent, and in step 3, the sample to be measured and the reagent are fixed so as to react. Wait time. In step 4, the post-reaction sample is irradiated with light from the light source 7, and in step 5, the light reflected by the post-reaction sample is detected by the light receiving device 8, and the light receiving device 8 sends out a voltage corresponding to the amount of received light. This voltage value corresponds to the above measured value. In step 6, the component amount deriving means 20 of the arithmetic unit 2
6 derives the measured component amount corresponding to the voltage value, in other words, the corresponding component amount from the table stored in the memory 205 based on the obtained voltage value, and measures the measured component derived in step 7. The component amount is displayed on the display device 4. still,
In step 6, when the measured value is a value other than the set value stored in the table, the component amount deriving means 206 of the arithmetic unit 2 obtains the measured component amount by the interpolation calculation as described above.

On the other hand, when the amount of the component to be measured is determined by using the table and the calibration curve together, the table and the calibration curve are selected in step 0, and step 6 shown in FIG.
The operation is replaced with steps 21 to 23 shown in FIG. That is, in step 21, the determination means 200 of the arithmetic unit 2 determines whether or not the voltage value obtained in step 5 is included in the above convertible range in which the measured component amount can be obtained using the calibration curve. If it is determined that the value is not included in the convertible range, the process proceeds to step 22 where the same operation as step 6 shown in FIG. 3 is performed. On the other hand, when the voltage value is included in the convertible range, the component amount deriving unit 201 determines in step S23 the memory 5 based on the obtained voltage value.
Convert the amount of component to be measured using the calibration curve stored in. The measured component amount obtained in steps 22 and 23 is displayed on the display device 4 in step 7.

Incidentally, in step 21, the judgment means 20
When it is determined that the voltage value is included in the conversion prohibited range at 0 and the measured component amount is derived using the above table, in step 7, it is determined that the measured component amount is derived using the table. It may be displayed on the display device 4 so as to notify the measurer. By making such a display, the measurer can perform the measurement again on the sample to be measured, or can dilute the sample to be measured and perform the measurement again. Can be higher.

The component amount deriving means 201, 206 are to be measured, for example, when a measured value outside the range included in the information of the table or the calibration curve, that is, a measured value for which no measurement is planned is supplied. When the component amount cannot be obtained, the component amount deriving means 201 and 206 display an error on the display device 4.

In each of the operations shown in FIGS. 3 and 4, the sample was irradiated with light after the reaction. However, the present invention is not limited to this. For example, the reaction section containing a reagent is formed by covering a pair of electrodes, The amount of the component to be measured may be determined by the voltage obtained by reacting the reagent with the sample to be measured and then applying a current between the electrodes.

As described above, according to the measuring method of this embodiment and the measuring apparatus using the measuring method, the following effects can be obtained. The correspondence between the set value and the corresponding component amount uniquely corresponding to the set value is previously obtained and stored in the form of a table, and the measured component amount, that is, the measured component amount is referred to by referring to the table during measurement. Since the corresponding component amount is derived, the true component amount or the component amount closest to the true component amount can be derived within the range described in the table. That is, when the amount of component to be measured is obtained by conversion using a calibration curve as in the past, if the difference between the true component amount and the component amount by conversion exceeds the allowable range, it will not be used due to accuracy problems. No, there was a measurement limit. On the other hand, in the present embodiment,
As described above, the measurable range can be expanded as compared with the conventional example.

When the amount of the measured component is obtained based on the reflectance, the relationship between the reflectance and the density of the measured component is a hyperbolic relationship as shown in FIG. 7, and the reflectance is low in the low density region. Since the reflectance is low in high and high density areas,
The measurement accuracy is low when the calibration curve representing the hyperbola is used. Therefore, conventionally, by interposing the item “K / S” as described above, as shown in FIG. 8, the linear relationship between the K / S function value and the concentration, in other words, the concentration value using the calibration curve is used. Was derived. However, by creating the relationship between the measured value and the density value in the table as in the present embodiment, it is not necessary to intervene the item K / S as in the conventional case.
In addition, the measurement accuracy can be improved.

[0035]

【Example】

[0036]

[Table 1]

Table 1 shows the voltage value obtained from the photodetector that received the reflected light in the post-reaction sample using the test piece 130 as described above, and the glucose concentration obtained by the voltage value. It shows a case where the relationship is obtained using only the calibration curve as in the conventional case and a case where it is obtained using only the table. Each value in the column of “reference method (true value)” shown in Table 1, Table 2, Table 4, and Table 5 is a predetermined measurement method that is reliable for the sample to be measured which is assumed to have these concentrations. It shows the measured value measured by, and is a value regarded as a true density value. As is apparent from Table 1, when only the calibration curve is used, the true concentration value is 38.
0 to 405.1 mg / dl, that is, 40 to 400 mg as shown in Table 3 in the measuring range of the measuring device.
The range of / dl was measurable. If it deviates from this range, the deviation degree exceeds 10% in the low concentration range and exceeds -10% in the high concentration range, and the error between the true value and the measured value becomes large, which is not practical. On the other hand, when the table is used, the true concentration value is 19.9 to 507.4 mg.
/ Dl, that is, in the measuring range of the measuring device, as shown in Table 3, a range of 20 to 500 mg / dl can be measured. The values set as the above “measurement range” are shown in Tables 1 and 2, in which the deviation degree is approximately ± 10% or less.
It is a value set within the range from the minimum density value to the maximum density value in the true density value corresponding to the “accuracy good range” shown by 4 and 5.

[0038]

[Table 2]

Table 2 uses the test strip 130 described above,
When the relationship between the voltage value obtained from the photodetector that receives the reflected light in the sample after the reaction and the concentration of total bilirubin obtained by the voltage value is obtained using only a calibration curve as in the conventional case, It shows the case of using only the table. As is clear from Table 2, when only the calibration curve is used, the true concentration value is 0.46 to
It was possible to measure 20.02 mg / dl, that is, a range of 0.5 to 20 mg / dl in the measuring range of the measuring device. If it deviates from this range, the deviation degree exceeds 10% in the low concentration range and exceeds −10% in the high concentration range, and the error between the true value and the measured value becomes large, which is not practical. On the other hand, when using the table, the true concentration value can be measured in the range of 0.18 to 30.39 mg / dl, that is, the range of 0.2 to 30 mg / dl in the measuring range of the measuring device. Becomes

[0040]

[Table 3]

Table 3 uses the test strip 130 described above,
For various measured components, in the case where the physical properties of the measurement are voltage values, the measurement range of the measuring device when determining the measured component amount using only the calibration curve as in the past, and when using only the table It shows the measurement range of the measuring device. As is clear from Table 3, the measurement range is wider when the table is used than when the calibration curve is used for any of the measured components.

[0042]

[Table 4]

Table 4 shows that the physical property in the measured value is voltage, and the electrode in which the reagent is applied to the counter electrode portion is used.
The relationship between the voltage obtained from the electrode and the glucose concentration obtained by the voltage in the post-reaction sample can be determined by using only a calibration curve as in the conventional case or by using only a table. It is shown. As is clear from Table 4, when only the calibration curve is used, the true concentration value is 39.9 to 506.6 mg / dl, that is, 40 to 500 mg in the measuring range of the measuring device.
The range of / dl was measurable. Outside this range, the degree of deviation exceeds 20% in the low concentration range and exceeds approximately -9% in the high concentration range, and the error between the true value and the measured value becomes large, making it impractical. On the other hand, when the table is used, the true concentration value is 19.8 to 649.7 mg /
dl, that is, 20 to 6 in the measuring range of the measuring device
A range of 00 mg / dl can be measured.

[0044]

[Table 5]

Table 5 shows that the physical property in the measured value is a voltage, and an electrode in which a reagent is applied to the counter electrode portion is used.
The relationship between the voltage obtained from the electrode in the post-reaction sample and the concentration of lactic acid obtained by the voltage can be obtained by using only a calibration curve as in the conventional case or by using only a table. It is shown. As is clear from Table 5, when only the calibration curve is used, the true concentration value is 9.9 to 140.3 mg / dl, that is, the range of 10 to 140 mg / dl in the measuring range of the measuring device. Was measurable. If it deviates from this range, the degree of deviation exceeds several percent in the low concentration range and exceeds about -9% in the high concentration range, and the error between the true value and the measured value becomes large, which is not practical. On the other hand, when the table is used, it is possible to measure a true concentration value of 4.9 to 180.9 mg / dl, that is, a range of 5 to 180 mg / dl in the measuring range of the measuring device. .

[0046]

As described above in detail, according to the measuring method according to the first aspect of the present invention and the measuring apparatus according to the third and fourth aspects, the measured values are set to the set values without using the calibration curve. The measured component amount is derived based on the correspondence relationship created in advance with the corresponding component amount. Therefore, even when the measured component amount is converted by the calibration curve as in the prior art, the range where the difference between the calculated component amount and the true component amount is large and the measurement accuracy deteriorates is The measuring method according to the aspect and the measuring devices according to the third and fourth aspects can obtain the amount of the component to be measured with high accuracy.

Further, according to the measuring method according to the second aspect and the measuring apparatus according to the fifth and sixth aspects, even when the amount of the component to be measured is obtained by the conversion with the calibration curve, it is obtained by the conversion. For the range where the difference between the component amount and the true component amount is small and the measurement accuracy is good, the amount of component to be measured is obtained using a calibration curve as in the conventional method. On the other hand, when the measured component amount is obtained by conversion using the calibration curve, in the range where the difference between the component amount obtained by conversion and the true component amount is large and the measurement accuracy deteriorates, the set value and the corresponding component amount are The amount of component to be measured is derived based on the correspondence created in advance. Therefore, according to the measuring method according to the second aspect and the measuring apparatus according to the fifth and sixth aspects, the amount of the component to be measured can be obtained with high accuracy in the entire measurement range.

Further, storing the correspondence between the set value and the corresponding component amount in the memory in the form of a table uses a large storage capacity in the memory,
According to the measuring device of the fifth and sixth aspects, since the calibration curve is used for a part of the measurement range to obtain the amount of the component to be measured, it is possible to reduce the memory capacity required to store the above correspondence. it can.

[Brief description of drawings]

FIG. 1 is a block diagram showing the configuration of a measuring apparatus that uses the method for measuring an amount of a component to be measured according to the present invention and uses both a calibration curve and a table.

2 is a block diagram showing a configuration of a measuring unit shown in FIG. 1 when the measuring apparatus shown in FIG. 1 measures the reflectance of light with respect to a sample to be measured.

FIG. 3 is a flowchart showing a method for measuring an amount of a component to be measured according to the present invention, which is a flow chart when a physical property in a measured value is a voltage and the amount of the component to be measured is obtained using a table over the entire measurement range.

FIG. 4 is a flowchart in a case where both the table and the calibration curve are used together to obtain the measured component amount in the flowchart shown in FIG. 3.

FIG. 5 shows a method for measuring an amount of a component to be measured according to the present invention,
It is a graph for explaining one determination method of the measurement value described in the table.

FIG. 6 is a block diagram showing a configuration of a measuring apparatus that uses the method for measuring an amount of a component to be measured according to the present invention and uses only a table.

FIG. 7 is a graph showing the relationship between the reflectance of light in the sample after the reaction and the concentration of the component to be measured.

FIG. 8 is a graph for explaining the relationship between the calibration curve and the amount of component to be measured.

FIG. 9 is a perspective view showing the configuration of a sample piece for measuring the concentration of a component to be measured by utilizing the reflection of light in the sample after the reaction.

10 is a diagram showing a cross-sectional shape of the sample piece shown in FIG. 9 and a schematic structure of a measuring device.

[Explanation of symbols]

DESCRIPTION OF SYMBOLS 1 ... Measuring means, 2 ... Arithmetic device, 3 ... Control part, 4 ... Display device, 5 ... Memory, 6 ... Reagent, 7 ... Light source, 8 ... Light receiving device,
10 ... Measuring device, 200 ... Judging means, 201 ... Component amount deriving means, 205 ... Memory, 206 ... Component amount deriving means, 2
10 ... Measuring device.

Claims (18)

[Claims] 1. A measuring method for obtaining an amount of a component to be measured of a component to be measured contained in the sample to be measured based on a measured value in a certain physical property measured by using a post-reaction sample obtained by reacting a sample to be measured with a reagent. That is, the measured component amount for the measured value is a preset value in the same physical property as the physical property in the measured value, and the corresponding component amount that uniquely corresponds to the set value in the measured component. A method for measuring the amount of a component to be measured, which is derived based on a table showing the correspondence relationship of (S6, S16). 2. The amount of the measured component of the measured component contained in the measured sample is obtained based on the measured value of a certain physical property measured by using the post-reaction sample obtained by reacting the measured sample with a reagent, A calibration curve is obtained in advance based on a plurality of known component amounts in the measured component contained in the measured sample and a plurality of known measured values corresponding to the known component amounts, and the calibration curve for the measured values is obtained. A measurement method for obtaining the amount of the component to be measured based on the above, when the measured value is included in the convertible range in which the amount of the component to be measured can be obtained based on the calibration curve If the measured component amount is calculated based on the above (S21, S23, S31, S33), and the measured value is included in the conversion prohibited range where the measured component amount cannot be calculated based on the calibration curve. The,
The measured value for the measured value based on the table showing the correspondence relationship between the preset value in the same physical property as the measured value and the corresponding component amount uniquely corresponding to the set value in the measured component A method for measuring an amount of a component to be measured, which comprises deriving an amount of the component (S21, S22, S31, S32). 3. The component to be measured according to claim 2, wherein when there are two said conversion prohibited ranges, said convertible range is sandwiched by said conversion prohibited ranges, and each conversion prohibited range and said convertible range are continuous. How to measure quantity. 4. The method for measuring the amount of a component to be measured according to claim 1, wherein the reagent is a reagent utilizing dry chemistry. 5. The method for measuring the amount of a component to be measured according to claim 1, wherein the component to be measured is a component in the field of biochemistry. 6. The measured component is glucose, and when the measured value is a voltage value, the measurement range of the measured component amount is 20 mg / dl to 500 mg / dl.
The method for measuring the amount of a component to be measured described. 7. The measured component is lactic acid, and when the measured value is a voltage value, the measuring range of the measured component amount is 5 m.
The method for measuring the amount of a component to be measured according to claim 5, which is g / dl to 180 mg / dl. 8. The measured component is bilirubin, and when the measured value is a voltage value, the measurement range of the measured component amount is 0.2 mg / dl to 30 mg / dl.
The method for measuring the amount of a component to be measured described. 9. A method for obtaining an amount of a component to be measured of a component to be measured contained in the sample to be measured based on a measured value in a certain physical property measured by using a post-reaction sample obtained by reacting a sample to be measured with a reagent. A measuring device using a method for measuring an amount of a component to be measured, wherein the amount of the component to be measured with respect to the measured value is a set value preset in the same physical property as the physical property in the measured value, and An apparatus for measuring an amount of a component to be measured, which is derived based on a table showing a correspondence relationship with a corresponding component amount that uniquely corresponds to a set value. 10. A method for determining an amount of a component to be measured of a component to be measured contained in the sample to be measured based on a measured value in a certain physical property measured by using a post-reaction sample obtained by reacting a sample to be measured with a reagent. A measuring device that uses a method for measuring an amount of a component to be measured, wherein a preset value is set in advance in the same physical property as that of the measured value, and an amount of a corresponding component uniquely corresponding to the set value in the measured component. And a memory (205) for storing a table showing a correspondence relationship between the measured value and the component amount deriving means (20) for reading the corresponding component amount corresponding to the measured value from the memory.
6) And the measuring device of the to-be-measured component amount characterized by including these. 11. An amount of a measured component of a measured component contained in the measured sample is obtained based on a measured value of a certain physical property measured by using a post-reaction sample obtained by reacting a measured sample with a reagent, A calibration curve is obtained in advance based on a plurality of known component amounts in the measured component contained in the measured sample and a plurality of known measured values corresponding to the known component amounts, and the calibration curve for the measured values is obtained. A measurement device that uses a measurement method for determining the measured component amount based on the above, when the measured value is included in the convertible range in which the measured component amount can be calculated based on the calibration curve Is the amount of the component to be measured based on the calibration curve, when the measured value is included in the conversion prohibited range in which the amount of the component to be measured cannot be determined based on the calibration curve,
The measured value for the measured value based on the table showing the correspondence relationship between the preset value in the same physical property as the measured value and the corresponding component amount uniquely corresponding to the set value in the measured component An apparatus for measuring an amount of a component to be measured, which is characterized by deriving an amount of the component. 12. The amount of the component to be measured of the component to be measured contained in the sample to be measured is determined based on a measured value in a certain physical property measured by using a post-reaction sample obtained by reacting a sample to be measured with a reagent, A calibration curve is obtained in advance based on a plurality of known component amounts in the measured component contained in the measured sample and a plurality of known measured values corresponding to the known component amounts, and the calibration curve for the measured values is obtained. A measuring device using a measuring method for determining the amount of the component to be measured based on the above, wherein a preset value is set in advance in the same physical property as the physical property in the measured value, and the set value is uniquely corresponded to in the measured component. A memory (5) for storing a table showing the correspondence relationship with the corresponding component amounts and the information showing the calibration curve.
And a determination means (200) for determining whether or not the measured value is supplied and the supplied measured value is included in a convertible range in which the measured component amount can be obtained based on the calibration curve.
And electrically connected to the determination means, and when the determination means determines that the measured value falls within the convertible range, the measured value is information indicating the calibration curve stored in the memory. The amount of the component to be measured is calculated based on
On the other hand, when the determination means determines that the measured value is included in the conversion prohibited range in which the measured component amount cannot be obtained based on the calibration curve, the measured value is stored in the table stored in the memory. An apparatus for measuring a measured component amount, comprising: a component amount deriving unit (201) for obtaining the measured component amount based on the above. 13. The component to be measured according to claim 12, wherein when there are two said conversion prohibited ranges, said convertible range is sandwiched by said conversion prohibited ranges, and each conversion prohibited range and said convertible range are continuous. Quantity measuring device. 14. The apparatus for measuring the amount of a component to be measured according to claim 9, wherein the reagent is a reagent utilizing dry chemistry. 15. The apparatus for measuring the amount of a component to be measured according to claim 9, wherein the component to be measured is a component in the field of biochemistry. 16. The component to be measured is glucose,
The measuring device for measuring the amount of the component to be measured according to claim 15, wherein the measuring range of the amount of the component to be measured is 20 mg / dl to 500 mg / dl when the measured value is a voltage value. 17. The measured component is lactic acid, and when the measured value is a voltage value, the measuring range of the measured component amount is 5
The measuring device for measuring the amount of the component to be measured according to claim 15, which is in the range of mg / dl to 180 mg / dl. 18. The component to be measured is bilirubin,
The measuring device for measuring the amount of the component to be measured according to claim 15, wherein the measuring range of the amount of the component to be measured is 0.2 mg / dl to 30 mg / dl when the measured value is a voltage value.