WO1999006822A1

WO1999006822A1 - Clinical examination apparatus and method

Info

Publication number: WO1999006822A1
Application number: PCT/JP1998/003467
Authority: WO
Inventors: Toshihiko Harada
Original assignee: Kyoto Daiichi Kagaku Co., Ltd.
Priority date: 1997-08-04
Filing date: 1998-08-03
Publication date: 1999-02-11
Also published as: JP3203411B2; AU8463498A

Abstract

A clinical examination apparatus for measuring the concentrations of constituents in a sample by bringing a test piece (11) having a plurality of reagent portions (11a) into contact with a sample, reacting the reagent portions (11a) with the constituents of the sample, and irradiating the reagent portions (11a) with light to measure the reflectances at the reagent portions (11a). The apparatus comprises a temperature-measuring instrument (3) for measuring the temperature of the test piece (11), a reflectance measuring unit (4) for measuring the reflectances of the reagent portions (11a), and a controller (5) for calculating corrected reflectances based upon the correction functions corresponding to the constituents upon receiving the temperature measured by the temperature measuring instrument (3) and the reflectances measured by the reflectance measuring unit (4), and for determining the concentrations of the constituents based upon the corrected reflectances.

Description

Description Clinical test apparatus and method

The present invention determines the reaction progress of a reaction reagent that reacts with a sample in a reagent portion (for example, a reagent pad) of a test piece based on the reflectance of light, and determines the reaction rate of a component substance in the sample in accordance with the reaction progress. The present invention relates to a clinical test device and a method for testing a concentration.

'' Jing Technology

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 the change in the reaction progress of the reagent pad 11a based on the light reflectance, and determines the reaction progress. The concentration of the component in the sample is detected according to.

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

Since the reaction rate of the reagent varies greatly due to the temperature, the reflectivity also varies according to the temperature. Therefore, if no countermeasures are taken against the temperature change, the component concentration cannot be accurately determined. To solve this problem, a clinical test device that determines the degree of reaction based on the reflectance of light has a temperature control mechanism that maintains a constant reference temperature near the reaction table on which the test specimen is placed. Some have. 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 device equipped 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 device is generally expensive and large in size. . However, depending on the 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

Therefore, an object of the present invention is to provide a clinical test apparatus and a clinical test apparatus capable of reducing manufacturing costs, satisfying the demand for miniaturization, and capable of quickly and accurately determining the component concentration under various temperature environments. It is intended to provide a way.

According to the first aspect of the present invention, a test piece 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 reducing the concentration of the component material. A clinical test apparatus for testing, comprising: 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; and a measurement from the temperature measuring means. A reflectance correction unit that receives a temperature and a measured reflectance from the reflectance measurement unit and calculates a corrected reflectance based on a predetermined correction function; and, based on the corrected reflectance, A clinical test apparatus is provided, comprising: a determination means for determining a concentration.

According to the clinical test apparatus having the above 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 device can be reduced, and the demand for miniaturization can be satisfied. By appropriately defining the correction function in accordance with the component materials, the corrected reflectance will almost accurately represent the component concentration regardless of the temperature change. It can be done accurately.

Examples of the temperature measuring means include a resistance type sensor such as a ceramic capacitor and a capacitance type temperature sensor such as a ceramic capacitor. The force is not limited to these, and it is only necessary to be able to convert a temperature change into an electric signal convenient for arithmetic processing. Examples of the reflectivity measuring means include a photoelectric element such as a phototransistor or a photoconductive cell. There is no particular limitation on the power and power, as long as it can convert the reflectance into an electric signal convenient for operation.

The reflectance correction means and the determination means can be realized by a dedicated microcomputer including, for example, a CPU. According to the second aspect of the present invention, a plurality of reagent parts may be installed on a general personal computer in which the software necessary for calculating the corrected reflectance may be installed. A clinical test apparatus for testing the concentration of the above-mentioned test substance by bringing the test specimen into contact with the specimen and reacting each reagent portion with the substance in the specimen, and measuring the temperature of the test specimen. 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 a measured reflectance from the reflectance measuring unit. A clinical test apparatus is provided, comprising: a controller for calculating a corrected reflectance based on a correction function corresponding to the above component substance, and determining a concentration of the component substance based on the corrected reflectance. You.

According to a preferred embodiment of the second aspect of the present invention, the controller includes a CPU and a memory, wherein the memory stores a correction function corresponding to different component materials, Is configured to read a corresponding correction function from the memory according to the component substance to be inspected. Further, the test piece is disposed 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 determination result to be output to the printer.

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 the third aspect of the present invention, a test piece 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 reducing the concentration of the component material. A clinical test method for testing, comprising: a temperature measurement step for measuring the temperature of the test piece; a reflectance measurement step for irradiating the reagent portion with light to measure the reflectance; and the measurement temperature and the measurement. Using the reflectance, based on a predetermined correction function, A clinical test method is provided, comprising: a reflectance correction step of calculating a corrected reflectance; and a determining step of determining a concentration of the component substance based on the corrected reflectance. 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 FIGURES

FIG. 1 is a perspective view showing the overall configuration of a clinical test apparatus according to one embodiment of the present invention.

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

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

FIG. 4 is a block diagram showing a configuration of a controller in the clinical test apparatus. Figure 5 is a table showing the statistical data of the reflectance 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.

Figure 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.

FIGS. 9a and 9b are tables respectively showing the corrected reflectance and the measured reflectance for five different concentration samples obtained for the constituent ketone bodies.

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

FIGS. 10a and 1Ob are tables respectively showing the corrected reflectance and the measured reflectance for five different concentration samples obtained for "glucose" as a component substance.

Figures 11a and 11b show the five differences obtained for “occult blood” as a component substance. 9 is a table showing a corrected reflectance and a measured reflectance for each density sample. Figures 12a and 12b are tables showing the corrected and measured reflectances for five different concentration samples, respectively, obtained for "leukocyte" as a constituent substance.c 5 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 specifically described with reference to the accompanying drawings.

As shown in Fig. 1 to Fig. 3, the clinical test equipment mainly consists of a reaction table 1, a drive motor 2, a temperature measurement device 3, a reflectance measurement unit 4, a controller 5, a printer 6, a display unit. 7. Operation unit 8 and power supply 9 are provided. The reaction table 1 is arranged so as to be partially (approximately half) exposed above the support 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 strip 11 is provided with a plurality of reagent pads (reagent portions) 11a that exhibit a color reaction in response to a sample such as urine. Each reagent pad 1 1 _a, the different reagents are impregnated. The light reflectance of the reagent pad 11a (which changes depending on the color of the reagent pad 11a) indicates the reaction progress of the reagent, and the reaction progress indicates the concentration of a 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 is composed of 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 is built in the reaction table 1, and does not require a separate space for the temperature measuring device 3. No. 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 is composed of a light source 4a, a lens 4b, a filter 4c, an integrating sphere 4d, a light receiving element 4e, a slide mechanism 4f, and a position sensor 4 g. The light source 4a is composed of, for example, an LED, and irradiates light to each test piece 11 via a lens 4b and a filter 4c. The reflected light 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 4 e is composed of, for example, a photoelectric element such as a phototransistor. Each test piece 11 is slid in the longitudinal direction within the groove 1a of the reaction table 1 by the slide mechanism 4f, so that the light reflectance at each reagent pad 11a of the test piece 11 is reduced. Required sequentially. The position sensor 4 g detects light through a through hole 1 b formed below each groove 1 a 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 receives the measured temperature transmitted from the temperature measuring device 3 and the measured reflectance transmitted from the reflectance measurement unit 4, and calculates a corrected reflectance based on a predetermined collection function. Have. Further, the controller 5 has a function of calculating the component concentration in the specimen as a determination value based on the calculated corrected reflectance. Further, the controller 5 has a function of controlling the entire apparatus such as printing out the calculated determination value on the printer 6 and displaying the operation state of the apparatus on the display unit 7.

The operation unit 8 is used for inputting various settings such as a date.

FIG. 4 is a block diagram showing a specific configuration of the controller 5. As shown in the figure, the controller 5 includes a CPU 50, a ROM 51, a RAM 52, an EEPROM 53, and an interface 54. The CPU 50, the ROM 51, the RAM 52, the EEPROM 53, and the interface 54 are interconnected by a bus line. The bus lines include an address bus, a data bus, and a control signal line. A temperature measuring device 3, a reflectance measuring unit 4, a printer 6, a display unit 7, and an operation unit 8 are connected to the interface 54.

CPU 50 controls the entire laboratory device. The ROM 51 stores various programs for processing performed by the CPU 50. The RAM 52 temporarily stores programs, calculation results, and the like. The EPROM 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 EE PRO M53 based on the calculation program stored in the ROM 51, and substitutes the measured temperature and the measured reflectance into the correction function to calculate the corrected reflectance. Is calculated. The corrected reflectance is a value that is corrected based on the standard reflectance at a predetermined reference temperature. The standard reflectance was created based on statistical data collected from multiple specimens 11 reacted with different concentrations of component substances, and stored in EEPROM 53 as a regression function by regression analysis. Have been. Further, the correction function is a regression function defined for calculating the corrected reflectance by the regression analysis of the statistical data according to the standard reflectance function, and is detected from the sample in accordance with the concentration. It is specified for each component material and stored in EEPROM 53.

As described above, the measured reflectance is corrected using the standard reflectance and the correction function for the following reasons. The reaction between the component substance in the sample and the reagent in each reagent pad 11a of each test piece 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, for different concentrations of the component substances, the reflectance at a standard temperature (for example, 25 ° C) is determined in advance as the standard reflectance, and the measured reflectance at a temperature deviated from the standard temperature is statistically calculated. The correction is made using the determined correction function. As a result, the calculated corrected reflectance roughly represents the value that would be obtained if the reflectance measured at a temperature other than the standard temperature were 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 corrective reflectance as a determination value based on the determination information. The judgment information is based on the component substances corresponding to the standard reflectance at a predetermined reference temperature. A data map or conversion formula that converts the concentration of

It is defined for each component substance and is stored in EEPROM 53.

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

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

Figure 5 is a table showing statistical data of reflectance measured at each temperature using three types of samples with different concentrations when the component substance is a ketone body. In the statistical data table in the same table, the component concentrations were gradually 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, looking at the change in reflectance due to the change in temperature for each sample, it can be seen that, except for Sample 3, the reflectance decreases as the temperature increases. Based on such statistical data, the standard reflectance is defined, for example, as 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 used 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. The values of X and Y shown below are not percentage values but percentage values (for example, 70% is 0.7).

X = Y (1) On the other hand, the reflectance measured at temperatures other than 25 is expected to fluctuate upward or downward depending on the measured temperature, centered on the proportional function of the standard reflectance at 25 ° C. Is done. However, when the measured reflectance X is 0 and 100, the corrected reflection is independent of the measured temperature. The rates Y also converge to 0 and 100, respectively. As a result, when the measured temperature is higher than the reference temperature (25 ° C), the characteristic curve is such that it expands upward with respect to the proportional line of the standard reflectance, and when the measured temperature is lower than the reference temperature. Will be shown by a characteristic curve that swells downward from the proportional straight line of the standard reflectance. Therefore, by performing regression analysis by curve approximation based on these statistical data, the correction function f defined by the relative deviation term where the measured temperature T is one of the independent variables is assumed to be the following equation 2.

Y = f (X, T) = Χ + g (Τ) X ^m (1-X) ^η (2)

m, n: Arbitrary constants Here, the relative deviation term is a term defined by the following equation (3). g (T) X ^m (1 -X) ⁿ (3) The relative deviation term is defined as the product of the temperature factor with the measured temperature T as a variable and the reflectance factor with the measured reflectance X as a variable. . For example, according to the regression analysis by curve approximation using the least squares method with m and n being 2, approximation results as shown in the table of FIG. 7 can be obtained as different temperature factors for each temperature.

Based on the approximation results of the temperature factors shown in the table of FIG. 7, 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.) (4)

Α: Coefficient determined by the least squares method (A = 0.112)

To: Reference temperature (T. = 25) Based on the above, the correction function is determined by Equation 5 below. The coefficient Α is 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) For the above correction function, the measurement temperature and measurement indicated by the statistical data in Fig. 5. By substituting the reflectance, a corrected reflectance is obtained for each temperature as shown in FIG. Considering this correction data, the corrected reflectance at each temperature has a smaller error than the measured 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 in accordance with the reference temperature. Then, the controller 5 can calculate a judgment value (decision data) for each temperature by comparing the calculated corrective reflectance with the judgment information.

Figure 9a shows the corrected reflectance and judgment values at various temperatures obtained using five different samples (component substance: ketone body) different from those for which the data in Figures 5 and 8 were created. It is a table shown. For comparison, FIG. 9b is a table showing the measured reflectivity and the judgment value of the same five kinds of samples before collection. 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 (Τ-29) · X ² (1-Χ) ² (6) As shown in Fig. 9a, with correction, based on the corrected reflectance The determination values determined by the above are all consistent values according to the component concentration of each sample regardless of the measurement temperature. On the other hand, as shown in FIG. The judgment values are different values. As can be understood from this, it is understood that 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. Note that the abbreviation “FEF” used in FIGS. 9a and 9b (the same applies to FIGS. 10a to 12b described later) indicates the collection reflectance, and “M. FEFL.” The abbreviations indicate the measured reflectance. The abbreviation "EVT DV" indicates the 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. 1 Ob is a table showing the measured reflectance and the judgment value 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 (Τ-29) X (1-Χ) ³ (7) The above equation 7 is obtained by the equation 2 (Y = f (X, T) = X + g (T ) · X ^m (1-X) ⁿ ], where m = l, n = 3, and A = 0.021. As shown in Fig. 10a, when there is correction, the judgment value determined based on the corrected reflectance shows a value that matches all according to the component concentration of each sample regardless of the measurement temperature. I have. On the other hand, as shown in Fig. 1 Ob, in the case of no correction, for example, for sample 4, the judgment value at the reference temperature of 29 ° C was different from the judgment value at the measurement temperature of 15 ° C. It is. By appropriately setting the exponent values m and n and the coefficient A in Equation 2 according to the type of power, component, and component material, an appropriate corrected reflectance can be obtained, and it is not affected by the influence of the measurement temperature. It can be seen that a constant determination value is required.

In some cases, it may be more appropriate to use a correction function different from Equations 2 and 7 depending on the component substances. For example, when the component substance is occult blood in urine as a sample and the reference temperature is 29 ° C., it is preferable to use the following formula 8.

, 1/3

Y = X + 0.006 (T-29) {e 1} one (8)

e: Bottom of natural logarithm Figure 11a is a table showing the corrected reflectances and judgment values at various temperatures obtained using five types of samples containing occult blood as a component substance. Equation 8 above was used. For comparison, FIG. 11b is a table showing the measured reflectivity and the judgment value of the same five types of samples before collection.

As shown in Fig. 11a, when there is correction, the judgment is made based on the corrected reflectance The values are all consistent values according to the component concentration of each sample, regardless of the measurement temperature. On the other hand, as shown in Fig. 10b, in the case of no correction, the judgment value itself shows a value that matches all according to the component concentration of each sample regardless of the measurement temperature. The fluctuation range of the rate due to temperature change is larger than the corrected reflectance, and it is expected that this will affect the judgment value when 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 the correction function.

Y = X + 0.056 (T-29) {e ^{χ 1} · ² · [(0.93-Χ / Ο. 93)] ^2/ 3-1} (9) e: base of natural logarithm Figure 1 2 a is a table showing corrected reflectances and judgment 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 the measured reflectance and the judgment value before correction for the same five types of samples.

As shown in Fig. 12a, when there is correction, the judgment values determined based on the corrected reflectance show values that all match according to the component concentration of each sample regardless of the measurement temperature. I have. On the other hand, as shown in Fig. 12b, in the case of no correction, the judgment value fluctuated greatly due to the temperature change, and almost no accurate judgment value was obtained. As described above, depending on the type of component material, the correction of the reflectance may be decisive, and in that case, it is necessary to select an appropriate correction function. The abbreviation "NEG." In Figs. 12a and 12b indicates a negligible amount.

Next, the operation of the clinical test apparatus shown in FIGS. 1 to 4 will be described using the flowchart of FIG.

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

Subsequently, light is guided from the light source 4a to each reagent pad 11a of the test piece 11, and the reflectance of the light reflected by the reagent pad 11a is measured by the reflectance measurement unit 4. Measured by (Step S2). At this time, the slide mechanism 4 f 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 11 a and transmitted to the controller 5. Will be done.

Next, the CPU 50 of the controller 5, which receives the input of the measured temperature and the measured reflectance, calls an appropriate correction function from the EE PROM 53 for each component substance, and, for each measured reflectance, based on the correction function. Then, the specular reflectance is calculated (step S3).

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

Finally, the CPU 50 prints out the determination value on the printer 6 (step S5), and ends the routine of this determination processing.

Using the above clinical test equipment, the measured reflectance at various temperatures can be converted to the standard reflectance at a predetermined reference temperature (for example, 25 ° C or 29 ° C) based on an appropriate correction function according to the component substances. It can be converted to approximate corrected reflectance. 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. As a result, the manufacturing cost of the entire apparatus is reduced, and the size of the apparatus is reduced. Can be satisfied. Since the corrected reflectance is similar to the standard reflectance, the concentration of the component in the sample can be determined quickly and accurately without considering the influence of temperature during measurement. Further, since the correction function is selected according to the type of the component substances, an accurate corrected reflectance can be calculated for each component substance.

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. Further, by further increasing the number of concentration samples for each component substance, the correction function can be defined with higher estimation accuracy. 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 constituent substance.

Claims

The scope of the claims

1. A clinical test device for testing the concentration of the above-mentioned component substances 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,

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, and receiving a measured temperature from the temperature measuring means and a measured reflectance from the reflectance measuring means to form a predetermined correction function. A clinical test apparatus, comprising: reflectance correction means for calculating a corrected reflectance based on the corrected reflectance; and determination means for determining a concentration of the component substance based on the corrected reflectance. '

2. A clinical test apparatus for testing the concentration of the above-mentioned component substances by bringing a test strip 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 measurement unit for irradiating the reagent portion with light to measure the reflectance, and a measurement temperature from the temperature measuring device and a measurement reflectance from the reflectance measurement unit, and the A controller for calculating a corrected reflectance based on the corresponding correction function, and determining a concentration of the component substance based on the corrected reflectance;

Including, clinical testing equipment.

3. The controller includes a CPU and a memory, wherein the memory stores correction functions corresponding to different component materials, and the CPU responds from the memory according to the component material to be inspected. The clinical test device according to claim 2, wherein the clinical test device is configured to read out a correction function.

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. The clinical test apparatus according to claim 2, wherein the correction function is defined as a sum of the measured reflectance and a relative deviation term.

7. The clinical test apparatus according to claim 6, wherein the relative deviation term is 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.

8. A clinical test method for testing the concentration of the above-mentioned component substances by causing a test piece provided with at least one reagent part to contact with a specimen and reacting the above-mentioned reagent part with a component substance in the specimen. ,

A temperature measurement step for measuring the temperature of the test piece;

A reflectance measuring step of irradiating the reagent portion with light and measuring the reflectance, and a reflectance correction step of calculating a corrected reflectance based on a predetermined correction function using the measured temperature and the measured reflectance. When,

A determination step of determining the concentration of the component substance based on the specular reflectance.

9. The clinical test method according to claim 8, wherein the correction function is defined as a sum of the measured reflectance and a relative deviation term.

10. The clinical examination method according to claim 9, wherein the relative deviation term is 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.