JP3203411B2 - Clinical testing device and method - Google Patents

Description

Description: TECHNICAL FIELD The present invention relates to a reagent portion of a test strip (for example, a reagent pad).
The present invention relates to a clinical test apparatus and a method for judging the reaction progress of a reaction reagent reacting with a sample based on the reflectance of light and examining the concentration of a component substance in the sample according to the reaction progress.

BACKGROUND ART Generally, in this type of clinical test apparatus, a test is performed using a test piece to which a reagent pad containing a reaction reagent is attached. Specifically, after the test piece is immersed (contacted) in the sample, the clinical test apparatus determines a change in the reaction progress at the reagent pad 11a based on the light reflectance, and according to the reaction progress. It detects the concentration of the components in the sample.

In such a clinical test apparatus, on a reaction table on which a test piece is placed, the reflectance of light reflected by a reagent pad of the test piece is measured, and a microcomputer is used based on the measured reflectance. Determines the progress of the reaction of the reaction reagent, and calculates a determination value according to the component concentration in the sample. The reaction progress of the reagent is closely related to the reflectance of the test piece on the reagent pad, and the reaction progress can be determined by measuring the reflectance.

However, the reaction progress of the reagent greatly varies due to the influence of temperature, so that the reflectance also varies due to the influence of temperature. Therefore, if no measures are taken against the temperature change, the component concentration cannot be accurately determined.

As a solution to such a problem, a clinical test apparatus that determines the reaction progress based on the reflectance of light is provided with a temperature control mechanism that keeps a vicinity of a reaction table on which a test piece is mounted at a constant reference temperature. There are things. With such a temperature control mechanism, the reflectance is measured after a predetermined time elapses until the vicinity of the reaction table reaches a certain reference temperature.

However, a clinical test apparatus provided with a temperature control mechanism has a problem in that the manufacturing cost and the internal space required for the temperature control mechanism are increased, and the entire apparatus is generally expensive and large. Moreover, depending on such a temperature control mechanism, it takes time to reach a certain reference temperature, so that there is a problem that the inspection cannot be started quickly.

DISCLOSURE OF THE INVENTION Accordingly, an object of the present invention is to provide a clinical test which can reduce the manufacturing cost, satisfy the demand for miniaturization, and can quickly and accurately determine the component concentration under various temperature environments. It is intended to provide an apparatus and a method.

According to the first aspect of the present invention, a test strip having at least one reagent portion is brought into contact with a sample, and the reagent portion is reacted with a component material in the sample, thereby testing the concentration of the component material. A temperature measuring means for measuring the temperature of the test piece, a reflectance measuring means for irradiating the reagent portion with light to measure the reflectance thereof, and a measuring temperature from the temperature measuring means. And receiving the measured reflectance from the reflectance measuring means, based on a predetermined correction function,
A clinical test apparatus is provided, comprising: reflectance correction means for calculating a corrected reflectance; and determination means for determining the concentration of the component substance based on the corrected reflectance.

According to the clinical test apparatus having the above-described configuration, the corrected reflectance is calculated from the measured reflectance in consideration of the influence of the temperature change. Therefore, a temperature control mechanism that maintains the temperature of the test piece at a constant reference temperature during measurement. You don't need As a result, the manufacturing cost of the entire apparatus can be reduced, and the demand for downsizing can be satisfied. In addition, by appropriately defining the correction function according to the component substance, the corrected reflectance substantially accurately represents the component concentration regardless of the temperature change, so that the component concentration can be determined quickly and accurately. Can be.

Examples of the temperature measuring unit include a resistance type sensor such as a thermistor and a capacitance type temperature sensor such as a ceramic capacitor. However, the present invention is not limited to these, and any device can be used as long as it can convert a temperature change into an electric signal convenient for arithmetic processing.

As the reflectivity measuring means, for example, a photoelectric element such as a phototransistor or a photoconductive cell may be used. However, the present invention is not limited to these, and any device can be used as long as it can convert the reflectance into an electric signal convenient for arithmetic processing.

The reflectance correction means and the determination means can be realized by a dedicated microcomputer including, for example, a CPU. However, software necessary for the calculation processing of the corrected reflectance may be installed in a general personal computer.

According to the second aspect of the present invention, a test strip having a plurality of reagent portions is brought into contact with a sample, and each reagent portion is reacted with a component material in the sample, thereby testing the concentration of the component material. A clinical test apparatus, a temperature measuring device for measuring the temperature of the test piece, a reflectance measuring unit for irradiating the reagent portion with light to measure the reflectance, a measurement temperature from the temperature measuring device and Receiving the measured reflectance from the reflectance measurement unit, based on the correction function according to the component material, to calculate a corrected reflectance, based on the corrected reflectance, to determine the concentration of the component material And a clinical test apparatus including the same.

According to the preferred embodiment of the second aspect of the present invention,
The controller includes a CPU and a memory, wherein the memory stores correction functions corresponding to different component materials, and the CPU reads a corresponding correction function from the memory according to the component material to be inspected. It is configured as follows. The test piece is arranged on a reaction table, and the temperature measuring device is provided on the reaction table.

Preferably, the clinical test apparatus further includes a printer, and the controller causes the printer to output the determination result.

The correction function can be defined as the sum of the measured reflectance and the relative deviation term. In this case, the relative deviation term can be defined as a product of a temperature factor having the measured temperature as a variable and a reflectance factor having the measured reflectance as a variable.

According to a third aspect of the present invention, a test strip having at least one reagent portion is brought into contact with a sample, and the reagent portion is reacted with a component material in the sample, thereby testing the concentration of the component material. A temperature measurement step of measuring the temperature of the test piece, a reflectance measurement step of irradiating the reagent portion with light to measure the reflectance thereof, the measurement temperature and the measurement reflectance. And a determination step of determining a concentration of the component substance based on the corrected reflectance based on the corrected reflectance based on a predetermined correction function. Is done.

Other objects, features and advantages of the present invention will become more apparent from the detailed description given below with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view showing the overall configuration of a clinical test apparatus according to an embodiment of the present invention.

FIG. 2 is a schematic diagram showing main components of the clinical test apparatus.

FIG. 3 is a block diagram showing a connection relationship of main components in the clinical test apparatus.

FIG. 4 is a block diagram showing a configuration of a controller in the clinical test device.

FIG. 5 is a table showing the statistical data of the reflectivity measured at each temperature using three different types of concentration samples.

FIG. 6 is a graph showing the relationship between the measured reflectance and the corrected reflectance at each measurement temperature.

FIG. 7 is a table showing the approximation results of different temperature factors for each temperature obtained by curve approximation using the least squares method.

FIG. 8 is a table showing the corrected reflectance for each temperature obtained by performing correction on the sample shown in FIG.

9a and 9b were obtained for the component ketone bodies,
5 is a table showing corrected reflectances and measured reflectances for five different density samples, respectively.

FIGS. 10a and 10b are tables respectively showing the corrected reflectance and the measured reflectance for five different concentration samples obtained for the “ketone body” as a component substance.

FIGS. 10a and 10b are tables showing corrected and measured reflectances for five different concentration samples, respectively, obtained for "glucose" as a component.

FIGS. 11a and 11b are tables respectively showing the corrected reflectance and the measured reflectance for five different concentration samples obtained for “occult blood” as a component substance.

FIGS. 12a and 12b are tables respectively showing the corrected reflectance and the measured reflectance for five different concentration samples obtained for “leukocyte” as a component substance.

FIG. 13 is a flowchart showing a control operation of the clinical test apparatus shown in FIGS.

BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, preferred embodiments of the present invention will be described with reference to the accompanying drawings.

As shown in FIGS. 1 to 3, the clinical test apparatus mainly includes a reaction table 1, a drive motor 2, a temperature measuring device 3,
Reflectance measurement unit 4, controller 5, printer 6,
A display unit 7, an operation unit 8, and a power supply 9 are provided. The reaction table 1 is arranged so as to be partially (about half) exposed above the support base 10a of the apparatus main body 10 (see FIG. 1). Further, the printer 6, the display unit 7, and the operation unit 8 (including a plurality of key switches) are arranged at appropriate portions of the apparatus main body 10.

The reaction table 1 is formed in a disk shape by, for example, resin molding. On the surface of the reaction table 1, a plurality of grooves 1a for accommodating the strip-shaped test pieces 11 are formed radially at regular angular intervals. Each test piece 11
For example, a plurality of reagent pads (reagent portions) 11a that show a color reaction in response to a sample such as urine are provided. Each reagent pad 1
1a is impregnated with different reagents. The light reflectance (changes depending on the color of the reagent pad 11a) of the reagent pad 11a indicates the reaction progress of the reagent, and the reaction progress indicates the concentration of the specific component in the sample. Therefore, by measuring the reflectance of the reagent pad 11a, the concentration of the specific component in the sample can be determined.

The reaction table 1 is driven to rotate by a drive motor 2. The drive motor 2 includes a stepping motor or the like, and receives electric power from the power supply 9 to rotate the reaction table 1 by a predetermined step angle under the control of the controller 5.

The temperature measuring device 3 is for measuring the temperature in the vicinity of each test piece 11, and is composed of, for example, a temperature sensor such as a thermistor. In the illustrated embodiment, the temperature measuring device 3
Are built in the reaction table 1, and there is no need to separately arrange the space. The temperature measured by the temperature measuring device 3 is converted into an electric signal and transmitted to the controller 5.

As shown in FIG. 2, the reflectance measuring unit 4 includes a light source 4a, a lens 4b, a filter 4c, an integrating sphere 4d, a light receiving element 4e,
It has a slide mechanism 4f and a position sensor 4g. light source
4a is composed of, for example, an LED, and transmits light to the lens 4b and the filter 4.
Irradiate each test piece 11 via c. The light reflected from each reagent pad 11a on each test piece 11 is diffusely reflected on the inner surface of the integrating sphere 4d and enters the light receiving element 4f. The light receiving element 4e is formed of, for example, a photoelectric element such as a phototransistor, and converts the received reflected light into an electric signal and transmits the electric signal to the controller 5. Each test piece 11 is slid in the groove 1a of the reaction table 1 in the longitudinal direction by the slide mechanism 4f, whereby the light reflectance of each reagent pad 11a of the test piece 11 is sequentially obtained. The position sensor 4g detects light via a through hole 1b formed below each groove 1a in the reaction table 1. The slide mechanism 4f and the position sensor 4g are connected to the controller 5, whereby the controller 5 controls the operation of the drive motor 2 and the slide mechanism 4f.

The controller 5 is constituted by a so-called microcomputer and is built in the apparatus main body 10. The controller 5 determines the measured temperature transmitted from the temperature measuring device 3,
It has a function of receiving the measured reflectance transmitted from the reflectance measuring unit 4 and calculating a corrected reflectance based on a predetermined correction function. Further, the controller 5 has a function of calculating the component concentration in the sample as a determination value based on the calculated corrected reflectance. Further, the controller 5
Prints out the calculated judgment value on the printer 6,
It also has a function of controlling the entire apparatus, such as displaying the operation state of the apparatus on the display unit 7.

The operation unit 8 is used to input various settings such as a date.

FIG. 4 is a block diagram showing a specific configuration of the controller 5. As shown in FIG.
U50, ROM51, RAM52, EEPROM53, and interface 5
It has four. The CPU 50, the ROM 51, the RAM 52, the EEPROM 53, and the interface 54 are mutually connected by a bus line. The bus lines include an address bus, a data bus, and a control signal line. The interface 54 is connected to the temperature measurement base 3, the reflectance measurement unit 4, the printer 6, the display unit 7, and the operation unit 8.

The CPU 50 controls the entire clinical examination device. ROM51 is CP
Various programs for processing performed in U50 are stored. The RAM 52 temporarily stores programs, calculation results, and the like. The EEPROM 53 stores various functions and data. The interface 54 has an input / output function of a signal transmitted / received to / from the controller 5.

The CPU 50 calls the correction function stored in the EEPROM 53 based on the calculation program stored in the ROM 51, and calculates the corrected reflectance by substituting the measured temperature and the measured reflectance into the correction function. The corrected reflectance is a value corrected based on the standard reflectance at a predetermined reference temperature. The standard reflectance is created based on statistical data collected from a plurality of test pieces 11 reacted with different concentrations of component substances, and is stored in the EEPROM 53 as a regression function by regression analysis. Further, the correction function is a regression function defined for calculating a corrected reflectance by analyzing and analyzing the statistical data according to the function of the standard reflectance, and a component detected from the sample according to the concentration. It is defined for each substance and stored in the EEPROM 53.

As described above, the measured reflectance is corrected using the standard reflectance and the correction function for the following reason. The reaction between the component substance in the sample and the reagent on each reagent pad 11a of each test strip 11 is affected not only by the concentration of the component substance but also by the temperature. Therefore, the reflectance of each reagent pad 11a does not always accurately reflect the concentration of the component substance. Therefore, the standard temperature (for example, 25
The reflectance at (° C.) is defined as a standard reflectance, and the measured reflectance at a temperature deviated from the standard temperature is corrected using a statistically defined correction function. As a result, the obtained corrected reflectance roughly represents a value that would be obtained if the reflectance measured at a temperature other than the standard temperature was measured at the standard temperature.

The CPU 50 that has calculated the corrected reflectance calls the determination information stored in the EEPROM 53, and calculates the concentration of the component substance corresponding to the corrected reflectance as a determination value based on the determination information.
The determination information is a data map or a conversion formula for numerically converting the concentration of the component material according to the standard reflectance at a predetermined reference temperature as a stepwise determination value, is defined for each component material, and is stored in the EEPROM 53. .

The CPU 50 having calculated the determination value finally causes the printer 6 to print out the determination value. The component substances in the sample to be determined include ketone bodies, proteins,
Glucose, leukocytes, hemoglobin and the like. In addition, although it is not a component substance of the specimen, pH and the like can also be determined.

Next, a specific procedure from obtaining the corrected reflectance from the measured reflectance to further calculating the determination value will be described.

FIG. 5 is a table showing statistical data of reflectance measured at each temperature using three types of samples having different concentrations when the component substance is a ketone body. In the statistical data of the same table, the component concentrations are sequentially reduced from sample 1 to sample 3.

As can be seen from FIG. 5, the reflectance increases as the component concentration decreases. On the other hand, when looking at the change in the reflectance due to the change in the temperature for each sample, it can be seen that the reflectance decreases as the temperature increases, except for the sample 3. Based on such statistical data, the standard reflectance is defined as, for example, the reflectance at 25 ° C.

FIG. 6 is a graph showing the relationship between the measured reflectance and the corrected reflectance at different temperatures when 25 ° C. is set as the reference temperature. The horizontal axis of the graph actually shows the measured reflectance, and the vertical axis shows the corrected reflectance.

As can be seen from the graph of FIG. 6, the standard reflectance at 25 ° C. is defined as a proportional function by the following equation 1 where X is an independent variable and Y is a dependent variable. In addition, X shown below
And Y values are percentage values that are not percentage values (eg,
70% is 0.7).

X = Y (1) On the other hand, the reflectivity measured at a temperature other than 25 ° C. is expected to fluctuate upward or downward depending on the measured temperature, centering on the proportional normal of the standard reflectivity at 25 ° C. You. However, when the measured reflectance X is 0 and 100, the corrected reflectance Y converges to 0 and 100, respectively, regardless of the measurement temperature. As a result, the measured temperature becomes the reference temperature (25 ° C)
If the measured temperature is lower than the reference temperature, the characteristic curve will be swelled downward from the proportional line of the standard reflectance. It will be shown by such a characteristic curve.
Then, by performing a regression analysis by curve approximation based on these statistical data, the measured temperature T is set to one of the independent variables.
It is assumed that the correction function f defined by the two relative deviation terms is the following equation 2.

Y = f (X, T) = X + g (T) · X ^m (1−X) ⁿ (2) m, n: Arbitrary constant Here, the relative deviation term is defined by the following equation 3. Term.

g (T) · X ^m (1-X) ⁿ (3) The relative deviation term is defined as a product of a temperature factor having the measured temperature T as a variable and a reflectance factor having the measured reflectance X as a variable. Is done. For example, according to a regression analysis using a curve approximation using the least squares method, where m and n are 2, approximation results as shown in the table of FIG. 7 are obtained as different temperature factors for each temperature.

Based on the approximation results of the temperature factors shown in the table of FIG. 7, a regression analysis is performed by linear approximation using the least squares method, whereby the temperature factors are defined by the following equation 4.

g (T) = A (T−T ₀ ) (4) A: coefficient determined by the least squares method (A = 0.112) T ₀ : reference temperature (T ₀ = 25) Is determined by Equation 5 below. Note that the coefficient A is set to 0.125, which is slightly larger than the value determined by the least squares method.

Y = f (X, T) = X + 0.125 (T−25) · X ² (1-X)
² (5) When the measured temperature and the measured reflectance indicated by the statistical data in FIG. 5 are substituted for the correction function, the corrected reflectance is obtained for each temperature as shown in FIG. Considering this correction data, the corrected reflectance for each temperature is a numerical value having a smaller error than the measured reflectance for the standard reflectance at the reference temperature of 25 ° C. Therefore, the corrected reflectance obtained by such a correction function is calculated as a value approximating the standard reflectance according to the reference temperature. Then, the controller 5 can calculate a judgment value (judgment data) for each temperature by comparing the calculated corrected reflectance with the judgment information.

FIG. 9a shows another 5 from which the data of FIGS. 5 and 8 were created.
5 is a table showing corrected reflectances and determination values at various temperatures obtained using various types of samples (component substances: ketone bodies). For comparison, FIG. 9B is a table showing measured reflectances and determination values before correction for the same five types of samples. Note that the reference temperature used for these samples was 29 ° C., and the correction function was based on the following equation 6.

Y = f (X, T) = X + 0.16 (T−29) · X ² (1-X)
² (6) As shown in FIG. 9a, in the case where there is correction, the determination values determined based on the corrected reflectance all matched according to the component concentration of each sample regardless of the measurement temperature. Indicates the value. On the other hand, as shown in FIG.
For example, when the sample 5 is examined, the determination value at the measurement temperature of 16 ° C. is different from the determination value at the reference temperature of 29 ° C. than the determination value at the other measurement temperatures. As can be understood from this, a constant determination value that is not influenced by the measured temperature can be obtained by using the corrected reflectance calculated based on the correction function. The abbreviation "C.FEFL." Used in FIGS. 9a and 9b (the same applies to FIGS. 10a to 12b to be described later) indicates a corrected reflectance, and "M.FEF."
The abbreviation "L." indicates the measured reflectance. Also, "EVT
The abbreviation "DV" indicates an evaluation value.

FIG. 10a is a table showing corrected reflectances and determination values at various temperatures obtained using five types of samples containing glucose as a component substance. For comparison, FIG.
7 is a table showing measured reflectances and determination values before correction for the same five types of samples. The reference temperature used for these samples was 29 ° C., and the correction function was based on the following equation (7).

Y = f (X, T) = X + 0.021 (T-29) .X (1-X)
³ (7) The above equation 7 is obtained by the equation 2 [Y = f (X, T) = X + g (T) · X
^m (1-X) ⁿ ], m = 1, n = 3, A = 0.021
It is what it was. As shown in FIG. 10a, when correction is performed, the determination values determined based on the corrected reflectance show values that are all consistent according to the component concentration of each sample regardless of the measured temperature. On the other hand, as shown in FIG. 10b, in the case of no correction, for example, when the sample 4 is viewed, the measured temperature of 15 ° C.
, Different judgment values are obtained. From this,
By appropriately setting the index values m and n and the coefficient A in Equation 2 according to the type of the component substance, an appropriate corrected reflectance can be obtained, and a constant determination value that is not affected by the measurement temperature can be obtained. You can see that.

Further, depending on the component substance, it may be more appropriate to use a correction function different from Equations 2 and 7. For example, the component substance is occult blood in urine as a specimen, and the reference temperature is 29 ° C.
In this case, it is preferable to use the following Expression 8.

FIG. 11a is a table showing corrected reflectance and determination values at various temperatures obtained using five types of samples containing occult blood as a component substance, and the above equation 8 was used as a correction function. For comparison, FIG. 11B is a table showing measured reflectances and determination values before correction for the same five types of samples.

As shown in FIG. 11a, when there is correction, the determination values determined based on the corrected reflectance show values that are all consistent according to the component concentration of each sample regardless of the measured temperature. On the other hand, as shown in FIG.10b, even in the case of no correction, the judgment value itself shows a value that is all consistent according to the component concentration of each sample regardless of the measurement temperature. The fluctuation width due to the temperature change is larger than the corrected reflectance, and is expected to affect the judgment value when a fine judgment is required.

Further, when the component substance is white blood cells and the reference temperature is 29 ° C., it is preferable to use the following equation 9 as a correction function.

FIG. 12A is a table showing corrected reflectances and determination values at various temperatures obtained using five types of samples containing leukocytes as component substances, and the above equation 9 was used as a correction function. For comparison, FIG. 12B is a table showing measured reflectances and determination values before correction for the same five types of samples.

As shown in FIG. 12A, in the case where the correction is performed, the determination values determined based on the corrected reflectance show values that all match in accordance with the component concentration of each sample regardless of the measurement temperature. On the other hand, as shown in FIG. 12B, in the case of no correction, the judgment value greatly fluctuates due to a temperature change, and almost no accurate judgment value is obtained. As described above, depending on the type of the component material, the correction of the reflectance may be decisively important, and in that case, it is necessary to select an appropriate correction function. Note that the abbreviation "NEG."
Indicates a negligible amount.

Next, the operation of the clinical test apparatus shown in FIGS.
This will be described with reference to the flowchart of FIG.

First, when the operation of the determination process is started, the temperature measuring device 3
The temperature near the reaction table 1 on which the test piece 11 is placed is measured and transmitted to the controller 5 (step
S1).

Subsequently, the light source 4a is applied to each sample pad 11a of the test piece 11.
From the sample pad 11a, and the reflectance of the light reflected by the sample pad 11a is measured by the reflectance measuring unit 4 (step S2). At this time, the slide mechanism 4f of the reflectance measurement unit 4 slides the test piece 11, so that the reflectance is sequentially measured for each of the different reagent pads 11a and transmitted to the controller 5.

Next, the CPU 50 of the controller 5 having received the input of the measurement temperature and the measurement reflectance calculates an appropriate correction function for each component substance.
In addition to calling from the EPROM 53, a corrected reflectance is calculated for each measured reflectance based on the correction function (step S
3).

Next, the CPU 50 retrieves the determination information defined for each component substance from the EEPROM 53, and calculates a determination value for each corrected reflectance based on the determination information (step S4).

Finally, the CPU 50 causes the printer 6 to print out the determination value (step S5), and terminates the routine of this determination processing.

Using the above clinical test apparatus, based on an appropriate correction function according to the component substances, the corrected reflectance obtained by approximating the measured reflectance at various temperatures to the standard reflectance at a predetermined reference temperature (for example, 25 ° C. or 29 ° C.) Can be converted to rate. Therefore, there is no need for a temperature control mechanism for maintaining the temperature of the test piece 11 at a constant reference temperature at the time of measurement, and as a result, the manufacturing cost of the entire apparatus is reduced and the demand for miniaturization is satisfied. Can be. In addition, since the corrected reflectance approximate to the standard reflectance is used, the component concentration in the sample can be determined quickly and accurately without considering the influence of temperature at the time of measurement. Further, since the correction function is selected according to the type of the component material, an accurate corrected reflectance can be calculated for each component material.

In the above embodiment, a correction function is defined for each component substance based on statistical data of three or five types of concentration samples. However, by further increasing the number of concentration samples for each component substance, a correction function with higher estimation accuracy can be defined. Further, the correction function is not limited to the one described above, and the most appropriate one can be arbitrarily selected according to the type of the component substance.

Claims (6)

(57) [Claims] 1. A clinical test apparatus for testing the concentration of a component substance by bringing a test piece having at least one reagent part into contact with a sample and reacting the reagent part with a component substance in the sample. A temperature measuring means for measuring the temperature of the test piece; a reflectance measuring means for irradiating the reagent portion with light to measure the reflectance; a measuring temperature from the temperature measuring means and the reflectance measuring means A reflectance correction unit that receives the measured reflectance from the device and calculates a corrected reflectance based on a predetermined correction function; and a determination unit that determines the concentration of the component substance based on the corrected reflectance. The correction function is defined as the sum of the measured reflectance and the relative deviation term. The relative deviation term is a temperature factor with the measured temperature as a variable and a reflectance factor with the measured reflectance as a variable. And the product Defined by that, clinical testing apparatus. 2. A clinical test apparatus for testing the concentration of a component substance by bringing a test piece having a plurality of reagent parts into contact with a sample and reacting each reagent part with a component substance in the sample. A temperature measuring device for measuring the temperature of the test piece; a reflectance measuring unit for irradiating the reagent portion with light to measure the reflectance; and a measuring temperature from the temperature measuring device and the reflectance measuring unit. Receiving a measured reflectance of, based on a correction function according to the linear material, to calculate a corrected reflectance, based on the corrected reflectance, a controller for determining the concentration of the component material, The correction function is defined as the sum of the measured reflectance and the relative deviation term. The relative deviation term is a temperature factor having the measured temperature as a variable and a reflectance having the measured reflectance as a variable. Factors and It is defined as the product, clinical testing apparatus. 3. The controller includes a CPU and a memory, wherein the memory stores a plurality of different correction functions corresponding to different component materials, and the CPU stores the plurality of correction functions according to the component material to be inspected. The clinical test apparatus according to claim 2, wherein the clinical test apparatus is configured to read a corresponding correction function from a memory. 4. The clinical test apparatus according to claim 2, wherein the test piece is disposed on a reaction table, and the temperature measuring device is provided on the reaction table. 5. The clinical test apparatus according to claim 2, further comprising a printer, wherein the controller outputs the determination result to the printer. 6. A clinical test method for testing the concentration of a linear substance by bringing a test piece having at least one reagent portion into contact with a sample and reacting the reagent portion with a component substance in the sample. A temperature measurement step of measuring the temperature of the test piece; a reflectance measurement step of irradiating the reagent portion with light to measure the reflectance thereof; and a predetermined measurement using the measurement temperature and the measurement reflectance. A reflectance correction step of calculating a corrected reflectance based on the correction function of; and a determining step of determining the concentration of the component substance based on the corrected reflectance. The relative deviation term is defined as the product of a temperature factor with the measured temperature as a variable and a reflectance factor with the measured reflectance as a variable. Inspection methods.