JPWO2008096507A1 - Component measuring device - Google Patents

Abstract

The component measuring apparatus 1 has a blood measurement mode for measuring a test paper 53 to which blood has adhered and obtaining a blood sugar level, and a test liquid measurement mode for measuring the test paper 53 to which a test liquid has adhered and obtaining a blood sugar level. ing. A plurality of appropriate first calibration curves corresponding to a plurality of lots and a plurality of appropriate second calibration curves corresponding to a plurality of lots are stored in the data storage unit 13. In addition, each first calibration curve and each second calibration curve is assigned a calibration number that identifies it, and each storage container of the chip 5 has an appropriateness corresponding to the corresponding lot. A calibration number for specifying the first calibration curve and the second calibration curve is described.

Description

  The present invention relates to a component measuring apparatus.

  In recent years, with the increase in the number of diabetic patients, self blood glucose measurement in which patients themselves monitor fluctuations in daily blood sugar levels has been recommended, and blood glucose measurement devices (component measurement devices) are used for the blood glucose level measurement. .

  For example, this blood glucose measurement device supplies blood to a test paper or the like that is colored according to the amount of glucose in the blood, develops the color, and optically measures (measures) the degree of coloration. Color) to quantify the blood glucose level, and has a chip mounting part (test tool mounting part) for detachably mounting a chip (test tool) provided with a test paper.

  Also, an electrode that has at least two electrodes, a measurement electrode and a counter electrode, reacts with glucose using an enzyme such as GOD or GDH and a mediator, receives electrons transferred from the mediator on the electrodes as current, and converts it into a blood glucose level A device of the type and a chip (test device) used by being mounted on a mounting portion of the device are known.

  The chips are sold in a state where a plurality of chips obtained from the same manufacturing lot (lot) are stored in a storage container.

  By the way, when the lots are different, the characteristics of each chip are different from lot to lot (the chip characteristics vary from lot to lot). That is, when the blood sugar level is measured using chips obtained from different lots, different values are obtained even in the same blood sample, and it is difficult to accurately measure the blood sugar level.

  In view of this, a measuring apparatus for measuring components such as blood having a function of correcting a deviation in measured values due to a difference in lots has been proposed (see, for example, Patent Document 1). According to this, a blood glucose level can be measured accurately.

  In addition, a test liquid called “control liquid” used for confirming the measurement accuracy (accuracy) of a measurement system including a blood glucose measurement device and a chip is prepared for each model. This test liquid is pseudo blood whose components are different from actual blood.

  The user (patient) supplies the test liquid to the chip mounted on the blood glucose measurement device, spreads it, performs measurement, and confirms the measurement accuracy of the measurement system. If the value obtained by measuring this test solution is within the preset allowable range, the measurement accuracy is good (appropriate). On the other hand, if the value is outside the allowable range, the measurement accuracy is poor (unsuitable). It is said.

  Also in the measurement of this test solution, there is a problem that different values can be obtained when chips obtained from different lots are used, as in the case of the blood glucose level measurement.

  Further, in the conventional blood glucose measurement device having a function of correcting the deviation of the blood glucose measurement value due to the difference in the lot, the blood glucose level is also measured in the test solution, although the components and properties of the test solution and blood are different from each other. Since the same correction as that in the measurement is performed, an accurate value cannot be obtained (cannot be corrected sufficiently).

For this reason, the following countermeasure (1) or (2) is taken.
(1) An allowable range in measuring the test liquid for confirming the measurement accuracy of the measurement system is set for each lot from which chips are obtained.

  (2) The allowable range in the measurement of the test liquid for confirming the measurement accuracy of the measurement system is set sufficiently wide in consideration of the variation of the chip characteristics for each lot.

  However, in the measure of (1), it is necessary to set different allowable ranges for each lot from which chips are obtained, and to print the allowable ranges on the corresponding storage containers. There is a disadvantage that it takes.

  In the measure (2), since the allowable range is set wide, the user feels uneasy about the reliability of the measurement accuracy confirmation result of the measurement system, and in fact, the measurement accuracy confirmation result. The reliability is low. That is, if the allowable range is set too wide, even if the measurement accuracy of the measurement system is poor, the value obtained by measuring the test liquid is within the allowable range, or if the allowable range is set too narrow, Even if the measurement accuracy of the measurement system is good, the value obtained by measuring the test liquid may be outside the allowable range.

JP 2005-30983 A

  It is an object of the present invention to accurately measure the amount of a predetermined component in a specimen, and to change the allowable range in the measurement of the test liquid for each lot from which the test device is obtained, and to improve the measurement accuracy. It is an object of the present invention to provide a component measuring apparatus capable of accurately discriminating.

In order to achieve the above object, the present invention provides a sample measurement mode for obtaining a value indicating the amount of a predetermined component in a sample, and a test liquid in which a value corresponding to the amount of the predetermined component in the sample is set to a predetermined value. And a test liquid measurement mode for obtaining a value corresponding to the amount of the predetermined component in the sample,
A measuring unit that measures the amount of the predetermined component in the specimen using a test tool that can be detachably attached to the component measuring device;
Based on the first calibration curve used to determine the value indicating the amount of the predetermined component in the sample based on the measurement result of the sample by the measurement unit, and based on the measurement result of the test solution by the measurement unit, First storage means for storing a second calibration curve used for obtaining a value corresponding to the amount of the predetermined component in the specimen;
A value indicating the amount of the predetermined component in the sample is obtained using the first calibration curve, and a value corresponding to the amount of the predetermined component in the sample in the test solution is obtained using the second calibration curve. An analysis means for obtaining a value,
For each of a plurality of test tools in the same lot, an appropriate first calibration curve corresponding to the characteristics of the test tools in the same lot, or the first calibration curve stored in the first storage means is the appropriate First correction information for correcting the first calibration curve so as to be a first calibration curve, and a second calibration curve appropriate for the characteristics of the test tool of the same lot, or the first calibration curve Second correction information for correcting the first or second calibration curve is set so that the first or second calibration curve stored in the storage means becomes the appropriate second calibration curve. Has been
In the sample measurement mode, the analysis means uses the appropriate first calibration curve or the appropriate first calibration curve after the correction by the first correction information, and the measurement unit of the sample. Based on the measurement result by, obtain a value indicating the amount of the predetermined component in the sample,
In the test liquid measurement mode, the analysis means uses the appropriate second calibration curve or the appropriate second calibration curve after the correction by the second correction information, to The component measuring apparatus is configured to obtain a value corresponding to an amount of a predetermined component in the test liquid in the test solution based on a measurement result by a measuring unit.

  As a result, the amount of the predetermined component in the sample can be accurately measured, and the allowable range in the measurement of the test liquid is not changed for each lot from which the test tool is obtained (the allowable range is fixed to a certain range). The measurement accuracy of the measurement system composed of the component measuring device and the test tool can be accurately determined. That is, in particular, for the test liquid, a different allowable range is set for each lot from which the test device is obtained, and an operation (process) for printing the allowable range on each storage container of the corresponding test device is not required. Further, the allowable range can be narrowed compared to the case where the variation is set for each lot, and the accuracy of the measurement system using the test liquid can be confirmed more appropriately. Thereby, management of the measurement accuracy of a measurement system can be performed reliably.

In the component measuring apparatus of the present invention, the appropriate first calibration curve or the first correction information corresponding to the corresponding lot and the corresponding lot for each storage container storing the plurality of test devices of the same lot. Is attached with a second storage means storing the appropriate second calibration curve corresponding to the second correction information or the second correction information,
It is preferable to have reading means for reading information stored in the second storage means.

  As a result, it is possible to easily and surely obtain appropriate first and second calibration curves not only for existing test instruments but also for new rod test instruments manufactured later. it can.

  In the component measuring apparatus of the present invention, a plurality of the appropriate first calibration curves or a plurality of the first correction information corresponding to a plurality of lots and a plurality of the appropriate second corresponding to the plurality of lots. It is preferable that a calibration curve or a plurality of the second correction information is stored in the first storage means.

  Thereby, an appropriate first calibration curve and second calibration curve can be obtained easily and reliably.

  In addition, for a new rod test tool manufactured later, the first calibration curve or first correction information and the appropriate second calibration curve or second correction information are displayed as the first. By storing in the storage means, it is possible to easily and surely obtain appropriate first calibration curve and second calibration curve.

In the component measuring apparatus of the present invention, each storage container storing a plurality of test devices of the same lot has the appropriate first calibration curve or the first correction information corresponding to the corresponding lot, and Identifying information for specifying the appropriate second calibration curve or the second correction information corresponding to the lot to be displayed,
Input means for inputting the identifying information;
Based on the specifying information, the appropriate first calibration curve or the first correction information corresponding to the corresponding lot from the plurality of appropriate first calibration curves or the plurality of first correction information. And selecting the appropriate second calibration curve or the second correction information corresponding to the corresponding lot from the plurality of appropriate second calibration curves or the plurality of second correction information. And selecting means.

  Thereby, an appropriate first calibration curve and second calibration curve can be obtained easily and reliably.

In the component measuring apparatus of the present invention, the appropriate first calibration curve corresponding to the corresponding lot or the respective test container of each of the storage containers storing the plurality of test tools of the same lot or each of the storage containers, respectively. An information carrier for carrying information for specifying the first correction information and the appropriate second calibration curve corresponding to the corresponding lot or the second correction information is provided;
Reading means for reading information carried by the information carrier;
Based on the specifying information, the appropriate first calibration curve or the first correction information corresponding to the corresponding lot from the plurality of appropriate first calibration curves or the plurality of first correction information. And selecting the appropriate second calibration curve or the second correction information corresponding to the corresponding lot from the plurality of appropriate second calibration curves or the plurality of second correction information. And selecting means.

  Thereby, an appropriate first calibration curve and second calibration curve can be obtained easily and reliably.

  The component measuring apparatus of the present invention is preferably configured to switch to the sample measurement mode when the measurement in the test liquid measurement mode is completed.

  When the user finishes the measurement in the test liquid measurement mode, the user normally measures the amount of the predetermined component in the sample in the blood measurement mode, so that the user manually enters the sample measurement mode. It is possible to save the trouble of setting.

  The component measuring apparatus of the present invention is preferably configured to switch to the sample measurement mode when the measurement in the test liquid measurement mode is completed and, as a result, a value within an allowable range is obtained. .

  When the user finishes the measurement in the test liquid measurement mode and results in a value within the allowable range as a result, the user normally measures the amount of the predetermined component in the specimen in the blood measurement mode. Therefore, it is possible to save the user from manually setting the sample measurement mode.

  In the component measuring apparatus of the present invention, the test liquid measurement mode compares the obtained value with a preset allowable range, and the measurement accuracy of the measuring system configured by the component measuring apparatus and the test tool is measured. It is preferable that the mode is a mode for determining good or bad.

  As a result, the user can easily and reliably grasp whether the measurement accuracy of the measurement system composed of the component measuring device and the test tool is good (appropriate) or bad (inappropriate). As a result, the measurement accuracy of the measurement system can be managed more easily and reliably.

FIG. 1 is a plan view showing the internal structure of the first embodiment of the component measuring apparatus of the present invention. 2 is a cross-sectional side view of the component measuring apparatus shown in FIG. FIG. 3 is a block diagram of the component measuring apparatus shown in FIG. FIG. 4 is a longitudinal sectional view showing the configuration of the photometry unit of the component measuring apparatus shown in FIG. FIG. 5 is a longitudinal sectional view showing the configuration of the test device. FIG. 6 is a longitudinal sectional view showing a state in which the test device shown in FIG. 5 is mounted on the component measuring apparatus. FIG. 7 is a side view showing a state when blood is collected using the test device shown in FIG. FIG. 8 is a flowchart for explaining the operation of the component measuring apparatus shown in FIG. FIG. 9 is a flowchart for explaining the operation of the component measuring apparatus shown in FIG. FIG. 10 is a flowchart for explaining the operation of the second embodiment of the component measuring apparatus of the present invention. FIG. 11 is a block diagram showing a third embodiment of the component measuring apparatus of the present invention. FIG. 12 is a block diagram showing a fourth embodiment of the component measuring apparatus of the present invention.

  Hereinafter, the component measuring apparatus of this invention is demonstrated in detail based on suitable embodiment shown to an accompanying drawing.

  In addition, the component measuring device of the present invention is a device that measures the amount of a predetermined component in a specimen. However, in the following embodiments, the component measuring device of the present invention is typically used with the amount of glucose in blood ( A case where the present invention is applied to a blood glucose measurement device for measuring (blood glucose level) will be described.

  Before describing the embodiment of the component measuring apparatus of the present invention, first, an embodiment of a test tool used by being mounted on the component measuring apparatus of the present invention will be described.

  FIG. 5 is a longitudinal sectional view showing the configuration of the test device, FIG. 6 is a longitudinal sectional view showing a state in which the test device shown in FIG. 5 is mounted on the component measuring apparatus, and FIG. 7 uses the test device shown in FIG. It is a side view showing a state when blood is collected. In the following description, the left side in FIGS. 5 and 6 is referred to as the “base end”, and the right side is referred to as the “tip”.

  The tip (tip) (component measuring chip) 5 as a test tool shown in FIG. 5 also has a function as a sampling tool for collecting blood as a sample, and has a bottomed cylindrical tip body (test tool body). ) 51, a thin tube 52 projecting from the bottom 511 of the chip body 51, and a test paper 53 which is a test site installed in the chip body 51.

  The chip body 51 supports the test paper 53 and constitutes a mounting part for mounting the chip 5 to the tip part (chip mounting part) (test tool mounting part) of the photometric part 4 provided in the component measuring apparatus 1 described later. Is.

  The chip body 51 includes a bottom portion 511, a body portion 513, and a flange 514 formed on a base end outer periphery of the body portion 513. A pedestal 512 for fixing the test paper 53 is formed inside the bottom 511. The test paper 53 is fixed to the pedestal 512 at the outer peripheral portion (fixing portion 533) by a method such as fusion or bonding with an adhesive.

  The body part 513 constitutes a mounting part for mounting the chip 5 to the tip part of the photometric part 4 of the component measuring apparatus 1. That is, as shown in FIGS. 6 and 7, the tip portion (pressing member 47) of the photometric unit 4 is fitted inside the body 513 of the chip body 51, and the chip 5 is connected to the photometric unit of the component measuring device 1. Attach to 4. Hereinafter, the state shown in FIG. 6 is referred to as “chip mounting state”.

  The thin tube 52 is for collecting blood (specimen), and a sample introduction flow path 520 is formed therein. The sample introduction channel 520 extends in a direction substantially orthogonal to the test paper 53, and a sample inflow port 523 is formed at the front end, and a sample outflow port 527 is formed at the base end.

  A spacer 56 is formed at a position on the outer peripheral side of the pedestal portion 512 on the inner surface of the bottom portion 511 of the chip body 51 as a separation means for ensuring non-contact between the test paper 53 and the pressing member 47 of the photometry unit 4 in the chip mounting state. Has been.

  The spacer 56 is composed of a plurality of convex portions (for example, four at intervals of 90 °) arranged along the circumferential direction on the inner surface of the bottom portion 511. As shown in FIG. It abuts against the tip of the pressing member 47 of the portion 4 to prevent the tip of the pressing member 47 from contacting the test paper 53.

  By providing such a spacer 56, the test paper 53 is protected, and blood developed on the test paper 53 is prevented from adhering to the photometry unit 4 and being contaminated.

  In addition, the spacer 56 is in contact with the tip of the pressing member 47 in the state where the chip is mounted, and the distance between the test paper 53 and the light emitting element 41 and the light receiving element 42 of the photometry unit 4 or the light transmission described later with respect to the test paper 53. It also has a function of keeping the separation distance (average distance L) from the sex member 45 constant. As a result, measurement errors due to fluctuations in the distance and variations in optical characteristics can be reduced, which contributes to improvement in measurement accuracy.

  The chip 5 is not limited to a bottomed cylindrical shape having the flange 514 or the thin tube 52, and may be, for example, a small piece, a flat plate (plate), a sheet, or a stick.

  The chip body 51 and the thin tube 52 as described above are made of a rigid material having a predetermined rigidity. As such a rigid material, a highly hydrophilic material such as an acrylic resin or various resin materials subjected to hydrophilic treatment are preferable.

  The test paper 53 is obtained by carrying (impregnating) a reagent (coloring reagent) on a carrier capable of absorbing blood (specimen). This carrier is preferably composed of a porous membrane (sheet-like porous substrate). In this case, the porous membrane preferably has a pore size that can filter out red blood cells in blood.

  Examples of the carrier of the test paper 53 include, in addition to the porous film, a sheet-like porous substrate such as a nonwoven fabric, a woven fabric, and a stretched sheet.

  Examples of the constituent material of the carrier such as the porous membrane include polyesters, polyamides, polyolefins, polysulfones, and celluloses, but it is impregnated with an aqueous solution in which a reagent is dissolved. In order to perform rapid development, a hydrophilic material or a hydrophilic material is preferable.

  Examples of the reagent impregnating the carrier (porous membrane) include glucose oxidase (GOD), peroxidase (POD), 4-aminoantipyrine, N-ethyl N- (2-hydroxy-3) in the case of blood glucose measurement. -Sulfopropyl) -m-Toluidine and the like and a combination with a color former (coloring reagent) can be mentioned, and the others are appropriately selected according to the measurement component.

  The test paper 53 has an annular convex portion 532 that is provided on the inner peripheral side of the fixed portion 533 and projects in the distal direction. The annular convex portion 532 has a function of regulating blood development on the test paper 53. Thereby, excess blood is prevented from flowing out from the annular convex portion 532 to the outer peripheral side, and contamination due to blood adhesion is prevented.

  Such a chip 5 is stored in a predetermined storage container. In other words, the plurality of chips 5 including the test paper 53 obtained from the same lot are stored in the storage container.

  As shown in FIG. 7, blood is collected by first puncturing a fingertip or the like with a needle or a scalpel or the like, and allowing a small amount (for example, about 1 to 6 μL) of blood 18 to flow out from the puncture portion onto the skin.

  On the other hand, the tip 5 is attached to the tip portion (tip attachment portion) of the photometry unit 4 provided in the component measuring apparatus 1, and the end surface of the sample inflow side end portion 521 of the thin tube 52 is brought into contact with the skin. The blood 18 at the fingertip reaches the sample inlet 523 through the groove 522, is sucked by capillary action, flows in the sample introduction flow path 520 in the proximal direction, and reaches the sample outlet 527. At this time, the blood 18 at the fingertip is effectively inhaled from the side opening of the groove 522 (the portion opened to the outer peripheral surface of the thin tube 52), so that it is not scattered excessively on the skin and has little loss.

  When the development (attachment) of blood on the test paper 53 is completed, the glucose (target component) in the blood reacts with the reagent carried on the test paper 53, and color is displayed according to the amount of glucose. The component measuring device 1 measures the color of the colored test paper 53 and measures the intensity of the coloration, whereby the blood sugar level, which is the amount of the target component in the blood, is obtained.

  In addition, although it demonstrated using the test paper as a test site | part, in this invention, it is not limited to this, If the reflected light changes with target components, it can be used.

  Next, the component measuring apparatus of this invention is demonstrated in detail based on suitable embodiment shown to an accompanying drawing.

  In order to facilitate understanding of the present invention, first, the entire configuration and operation (action) of the whole component measuring apparatus will be described, and then the main part (feature) of the present invention will be described.

<First Embodiment>
1 is a plan view showing the internal structure of a first embodiment of the component measuring apparatus of the present invention, FIG. 2 is a sectional side view of the component measuring apparatus shown in FIG. 1, and FIG. 3 is the component measuring apparatus shown in FIG. FIG. 4 is a longitudinal sectional view showing the configuration of the photometry unit of the component measuring apparatus shown in FIG. In the following description, the left side in FIGS. 1, 2, and 4 is referred to as a “base end” and the right side is referred to as a “tip”.

  A component measuring apparatus (blood component measuring apparatus) 1 shown in these drawings has a casing 2, and a printed circuit board 3 is disposed in the casing 2. Further, the test paper 53 is measured at the front end of the casing 2 as a measurement unit for measuring a change caused by a reaction between glucose (predetermined component) in blood (specimen) and a reagent of the test paper 53 (photometry). A photometric unit (measuring unit) 4 for (measuring) is provided. A liquid crystal (LCD) display device 9 is installed in the window portion of the casing 2 as display means (notification means) for displaying (notifying) various kinds of information.

  On the printed circuit board 3, for example, a control means 10 constituted by a microcomputer is mounted, and controls various operations (operations of each part) of the component measuring apparatus 1. The control means 10 has a built-in arithmetic part (analyzing means) for calculating (determining) the amount of glucose (blood glucose level) that is a target blood component based on a signal (measurement result) from the photometric part 4. ing. This calculation unit also performs, for example, hematocrit value correction calculation, temperature correction calculation, and the like as necessary. The main function of the selection means is achieved (configured) by the control means 10.

  The photometry unit 4 includes a light emitting element (light emitting diode) 41 and a light receiving element (photodiode) 42, which are housed and held in a holder 43. The light emitting element 41 is electrically connected to the control means 10, and the light receiving element 42 is electrically connected to the control means 10 via an amplifier and an A / D converter 49 (not shown).

  The light emitting element 41 is operated by a signal from the control means 10 and emits pulsed light at a predetermined time interval. For example, the period of the pulsed light is about 0.5 to 3.0 msec, and the emission time of one pulse is about 0.05 to 0.3 msec.

  The wavelength of this pulsed light is preferably about 500 to 720 nm, more preferably about 580 to 650 nm in the case of blood glucose measurement.

  A tip (component measurement tip) 5 which is a test tool incorporating the test paper 53 as described above is detachably attached to the tip of the photometry unit 4. Specifically, a holding member 47 for fixing the light transmissive member 45 to the holder 43 is provided at the tip of the holder 43, and the chip 5 is attached to the tip of the photometry unit 4 ( In the chip mounting state), the proximal end portion of the chip body 51 is fitted to the pressing member 47, and the chip 5 is fixed to the pressing member 47 (see FIG. 6). That is, in this embodiment, the pressing member 47 constitutes a chip mounting part (test tool mounting part).

  In this chip mounted state, the tip of the pressing member 47 (tip of the opening 472) faces (faces) the test paper 53 provided in the chip 5. In this state, when the light emitting element 41 is turned on, the light emitted from the light emitting element 41 is irradiated onto the test paper 53, and the reflected light reflected by the test paper 53 is received by the light receiving element 42, and is subjected to photoelectric conversion. Is done. From the light receiving element 42, an analog signal corresponding to the amount of received light (the amount of reflected light) is output, amplified as desired, converted to a digital signal by the A / D converter 49, and input to the control means 10. Is done.

  Then, the control means 10 performs, for example, a predetermined calculation process based on the input signal using a calibration curve, which will be described later, and performs a correction calculation or the like as necessary to determine the amount of glucose in the blood ( Find your blood sugar).

  The component measuring apparatus 1 includes a power supply unit 6, a power supply voltage detection unit 7, a switch circuit 8, a control oscillation unit 11, a clock oscillation unit 12, a data storage unit (first storage unit) 13, a buzzer output unit 14, an external An output unit 15 and a temperature measurement unit 16 are provided.

  A battery 61 is loaded in the power supply unit 6. The power supply voltage detection unit 7 detects the voltage of the battery 61 and outputs the detected voltage value (detection value) to the control means 10. Thereby, the remaining amount of the battery 61 can be checked.

  The switch circuit 8 detects inputs of various switches as described below and inputs the signals to the control means 10. The switch types include, for example, a power switch, a measurement switch, a blood (specimen) measurement mode selection switch, a test liquid (control liquid) measurement mode selection switch, a specific information input switch, a stored data read switch, a time setting / change Examples thereof include a switch, a reset switch, a buzzer operation / non-operation selection switch, and a 50 Hz / 60 Hz commercial power frequency selection switch.

  The power switch can be turned on / off by pressing the operation button 31. The other switches can be operated by operating any one or a combination of two or more of the operation buttons 31 and the operation members 32, 33, and 34. The operation members 32 to 34 and the specifying information input switch constitute input means for inputting specifying information to be described later.

  The control oscillating unit 11 constitutes a timer, oscillates clock pulses at regular time intervals, and supplies a reference signal for operation of the microcomputer (microprocessing unit: MPU) of the control means 10.

  The clock oscillator 12 constitutes a clock that specifies an absolute time (date and time). The clock oscillator 12 oscillates clock pulses at regular time intervals and supplies a reference signal for operation of a clock control circuit built in the control means 10.

  The data storage unit 13 includes a first memory (RAM), a second memory (ROM), and a third memory (nonvolatile RAM) that is a rewritable nonvolatile memory. The photometric value (photometric data) input from the photometric unit 4, that is, the measured value (measured data) is stored in the first memory according to a predetermined format.

  Further, in the second memory, in order to obtain the blood glucose level based on the photometric value or the relationship between the absorbance obtained from the photometric value and the blood glucose level (target blood component amount), that is, the photometric value or the absorbance. The calibration curve to be used is stored. Examples of the calibration curve include an arithmetic expression and a table.

  The third memory stores in advance a calibration value unique to each device. Specific calibration values referred to here include, for example, a prescribed value for the amount of reflected light, a correction coefficient for calculating absorbance, and the like.

  The buzzer output unit 14 operates the buzzer based on a signal from the control means 10 and emits a sound.

  The external output unit 15 is for outputting data such as the obtained blood sugar level (target blood component amount) to an external device such as a personal computer. In this case, the external output unit 15 incorporates a communication driver such as RS232C. When performing infrared communication, the external output unit 15 incorporates an infrared light emitting element and its drive circuit.

  The temperature measuring unit 16 includes a temperature sensor (thermistor) that can measure the environmental temperature. The temperature measurement unit 16 measures temperature at any time, and the temperature information is stored in the first memory of the data storage unit 13. The temperature information read from the first memory is input to the control means 10 and used for temperature correction calculation of the blood sugar level (target blood component amount).

Next, the photometry unit 4 will be described with reference to FIGS. 4 and 6.
As described above, the photometry unit 4 includes the holder (photometry block) 43 to which the light emitting element 41 and the light receiving element 42 are fixed (fixed), the light transmissive member 45, and the light transmissive member 45 with respect to the holder 43. A pressing member 47 to be fixed is provided. The holder 43 allows light emitted from the light emitting element 41 to pass therethrough and guides the light to the light receiving element 42 through the first passage 431 for guiding the light to the test paper 53 and reflected light reflected by the test paper 53. A second passage 432 is formed.

  The first passage 431 and the second passage 432 become one at the tip of the holder 43 (join) and then open (open) at the tip of the holder 43. Thus, an opening 433 through which the first passage 431 and the second passage 432 are opened is formed at the tip of the holder 43.

  At the tip of the holder 43, that is, the portion facing the test paper 53 in the chip mounted state (the portion facing the test paper 53 in the chip mounted state), the concave portion 434 is arranged so that the first passage 431 is located substantially at the center. Is formed.

  In addition, an annular recess 435 that communicates with the recess 434 and is formed deeper than the recess 434 is formed on the outer periphery of the recess 434.

  An O-ring 46 is accommodated in the annular recess 435, and a light transmissive member 45 is accommodated in the recess 434, and the light transmissive member 45 is fixed to the holder 43 by the pressing member 47. ing.

  The presser member 47 has a substantially cylindrical shape, and is fitted to a proximal end side of a ring-shaped (annular) contact portion 471 that contacts the light transmitting member 45 and a distal end portion of the holder 43. A ring-shaped (annular) fitting portion 473 is formed to protrude. The fitting portion 473 is located on the outer peripheral side of the contact portion 471.

  The fitting portion 473 constitutes a mounting portion for mounting the presser member 47 to the distal end portion of the holder 43. That is, as shown in FIG. 6, the distal end portion of the holder 43 is inserted inside the fitting portion 473 of the pressing member 47, and the pressing member 47 is attached (fitted) to the holder 43.

  When the holding member 47 is attached to the tip of the holder 43 with the O-ring 46 and the light-transmitting member 45 housed in the annular recess 435, the contact portion 471 is attached to the light-transmitting member 45. It abuts and presses it toward the holder 43. The O-ring 46 presses the light transmissive member 45 toward the contact portion 471 by its elastic force. Thereby, the light transmissive member 45 is fixed to the holder 43. Thus, the first passage 431 and the second passage 432 (hereinafter simply referred to as “passage”) of the holder 43 are sealed by the light transmissive member 45 through the O-ring 46.

  Further, an adhesive reservoir 436 composed of a plurality of ring-shaped recesses is provided on the outer periphery of the tip of the holder 43. An adhesive is supplied into the adhesive reservoir 436, whereby the presser member 47 is fixed (fixed) to the holder 43.

  The method of fixing (fixing) the pressing member 47 to the holder 43 is not limited to the method using adhesion with an adhesive, and for example, methods such as fusion, fitting, and screwing may be used. If the pressing member 47 is fixed to the holder 43 by a fitting or screwing method, the light transmitting member 45 and the O-ring 46 can be conveniently replaced when necessary.

  With such a configuration, the light-transmitting member 45 isolates the test paper 53 and the path of the holder 43 (the photometry unit 4) when the chip is mounted.

  In this component measuring apparatus 1, since the passage of the holder 43 is sealed, entry of dust, water, blood (specimen), etc. into the passage is reliably prevented. Thereby, a blood glucose level can be measured with high measurement accuracy.

  Further, even when blood or the like adheres to the front end surface of the pressing member 47 (photometry unit 4) or the light transmissive member 45, the blood is easily and reliably removed by washing with a cleaning liquid such as disinfecting alcohol or water. You can also

  The outer peripheral part of the pressing member 47 functions as a fitting part into which the base end part of the chip 5 is fitted in the chip mounted state.

  In addition, an opening (through hole) 472 through which the light emitted from the light emitting element 41 and the reflected light reflected by the test paper 53 passes is formed in the approximate center of the pressing member 47. A space (hollow part) 19 is formed between the paper 53 and the light transmissive member 45. That is, in the chip mounting state, the opening 472 is located between the test paper 53 and the light transmissive member 45, and mainly the inner surface (inner peripheral surface) of the opening 472 and the base end of the test paper 53. A space 19 is defined by the surface on the side and the surface on the tip side of the light transmissive member 45.

  In the present embodiment, the opening 472 has a shape (similar shape) whose cross-sectional shape is substantially equal at any position from the distal end (outer end portion) to the proximal end (inner end portion). That is, the angle formed by the inner surface of the opening 472 and the contact portion 471 (the base end surface of the contact portion 471) is approximately 90 °. Thereby, the cross-sectional area of the space 19 is substantially constant from the end of the space 19 on the test paper 53 side (front end side) to the end of the light transmissive member 45 side (base end side).

  With such a configuration, even when a finger or the like comes into contact with the front end surface of the presser member 47, the effect that the finger or the like can be prevented from coming into contact with the front end surface (outer side surface) of the light transmissive member 45 (contact prevention effect). ) Is obtained.

  The thickness (average) of the light transmissive member 45 is slightly different depending on its constituent materials and is not particularly limited, but is preferably about 0.1 to 10 mm, more preferably about 0.3 to 3 mm. preferable. If the thickness of the light transmissive member 45 is too thin, the strength may decrease. On the other hand, if the thickness of the light transmissive member 45 is too thick, the photometry unit 4 is undesirably large.

  In addition, the shape of the light transmissive member 45 is preferably a shape corresponding to the opening 433, and the dimension of the light transmissive member 45 only needs to be large enough to cover the opening 433.

  Examples of the constituent material of the light transmissive member 45 include various glass materials and various resin materials.

  Moreover, as a constituent material of the holder 43 and the pressing member 47, various resin materials and various metal materials are mentioned.

  The light transmissive member 45 is not limited to a flat plate shape, and may be a lens shape, for example.

  Further, one or more desired coating layers may be formed on the surface of the light transmissive member 45. This coat layer can be provided for the purpose of, for example, improving the measurement accuracy and preventing the light transmissive member 45 from being scratched.

  From the viewpoint of improving measurement accuracy, as the coating layer, for example, an antireflection coating (AR coating) that prevents light emitted from the light emitting element 41 from being reflected by the surface (base end surface) of the light transmissive member 45, or An antireflection coating that prevents the reflected light reflected by the test paper 53 from being reflected by the surface (tip surface) of the light transmissive member 45, and disturbance light (especially infrared light) greatly affects the measurement accuracy. For example, a low-pass filter that selectively transmits light having a wavelength of 720 nm or less, a band-pass filter that selectively transmits light having a wavelength of about 500 to 720 nm (corresponding to the wavelength of light emitted from the light emitting element 41), and the like. Is preferably provided.

  Further, from the viewpoint of preventing the light transmissive member 45 from being scratched, as a coating layer, for example, a Si material, an Al material, a polyfunctional acrylic material, a urethane resin material, a melamine resin material, or the like is a main material. It is preferable to provide a reinforcing coat layer (hard coat layer).

  The O-ring 46 is made of an elastic material, and is set so that the diameter (diameter) in the longitudinal section is larger than the depth of the annular recess 435. As a result, the O-ring 46 comes into close contact with both the holder 43 and the light transmissive member 45 in a state where the light transmissive member 45 is installed in the recess 434. Thereby, the sealing property (liquid tightness or airtightness) of the passage of the holder 43 can be improved, and the above-described effects can be further improved.

  Examples of such elastic materials include various rubber materials (particularly those vulcanized) and various thermoplastic elastomers, and one or more of these can be used in combination.

  In addition, the installation position of the O-ring 46 is not limited to the illustrated one, and may be, for example, the outer peripheral portion of the light transmissive member 45.

  Now, the component measuring apparatus 1 measures a test paper 53 to which blood (specimen) adheres to obtain a value indicating the amount of glucose (blood glucose level) in the blood (blood sample) measurement mode, and glucose in the blood. A test solution (control solution) for measuring a test paper 53 to which a test solution (control solution) having a known value corresponding to the amount (blood glucose level) is attached to obtain a value corresponding to the amount of glucose (blood glucose level) in the blood ) Measurement mode.

  In the present embodiment, by operating the operation members 32 to 34, one of the blood measurement mode selection switch and the test liquid measurement mode selection switch is activated, and the blood measurement mode, the test liquid measurement mode, Either mode can be set.

  In the test liquid measurement mode, the obtained value is compared with a preset allowable range (appropriate range), and the measurement accuracy (accuracy) of the measurement system configured by the component measuring device 1 and the chip 5 including the test paper 53 is compared. ), That is, a mode for discriminating whether the measurement accuracy of the measurement system is good or bad (proper / unsuitable). And a test liquid is a liquid used in order to confirm the measurement precision of this measurement system. Further, the test liquid is pseudo blood whose components and properties are different from actual blood, and the value corresponding to the blood glucose level is known (set to a predetermined value).

  In the test liquid measurement mode, when the value obtained by measuring the test paper 53 to which the test liquid is adhered by the component measuring apparatus 1 is within a preset allowable range (appropriate range), the measurement accuracy is good (appropriate) On the other hand, if it is outside the allowable range, it is determined that the measurement accuracy is poor (unsuitable). This allowable range is stored in the second memory of the data storage unit 13, and the allowable range is described (displayed) in, for example, an instruction manual for the test liquid, a storage container in which the chip 5 is stored, and the like. ing.

  Here, the “value corresponding to the blood glucose level” is not the amount of glucose actually contained in the test liquid, but the measurement liquid in the component measuring apparatus 1 when the measurement accuracy of the measurement system is good (appropriate). This is a value obtained when the attached test paper 53 is measured. That is, the characteristics of the test liquid and blood differ depending on the presence or absence of blood cells, etc. Based on the difference, the amount of glucose contained in the test liquid and the value corresponding to the blood glucose level do not always match. For example, even when the “value corresponding to the blood glucose level”, that is, the value obtained by measuring with the test liquid in the component measuring apparatus 1 is 100 mg / dL, the amount of glucose actually contained in the test liquid is A case of only 80 mg / dL is conceivable. Hereinafter, the “value indicating the blood glucose level” and the “value corresponding to the blood glucose level” are also simply referred to as “blood glucose level”, respectively.

  The second memory of the data storage unit 13 is based on the photometric value of the photometric unit 4 of the test paper 53 to which blood has adhered or the absorbance obtained from the photometric value (hereinafter simply referred to as “photometric value”). Based on the first calibration curve (blood calibration curve) used for obtaining the blood glucose level and the photometric value of the photometry unit 4 of the test paper 53 to which the test solution is attached, the second calibration curve is used for obtaining the blood glucose level. A calibration curve (test solution calibration curve) is stored.

  In this case, the test paper 53 of the chip 5 in the storage container is stored in each storage container (for each of the plurality of chips 5 in the same lot) in which the plurality of chips 5 including the test paper 53 obtained from the same lot are stored. A first calibration curve appropriate for the characteristics and a second calibration curve appropriate for the characteristics of the test paper 53 of the chip 5 in the storage container are set. That is, a proper first calibration curve and a proper second calibration curve are set for each lot of a plurality of lots, and a plurality of proper first calibration curves corresponding to the plurality of lots are set. A plurality of appropriate second calibration curves corresponding to a plurality of lots are stored in the second memory of the data storage unit 13. In addition, as a 1st calibration curve and a 2nd calibration curve, an arithmetic expression, a table, etc. are mentioned, for example, respectively.

  In addition, each first calibration curve and each second calibration curve stored in the data storage unit 13 has a calibration number (specification) for identifying the first calibration curve and the second calibration curve, respectively. Information) is assigned.

  On the other hand, each storage container of the chip 5 has a calibration number (specifying for specifying) an appropriate first calibration curve corresponding to the corresponding lot and an appropriate second calibration curve corresponding to the corresponding lot. Information) is written (displayed).

  In the present embodiment, by operating the operation members 32 to 34, the identification information input switch is operated, and a predetermined calibration number (identification information) is input.

  The user operates the operation members 32 to 34 to input the calibration number described in the storage container of the chip 5 to be used.

  Thereby, the control means 10 selects the first calibration curve of the inputted calibration number from the plurality of first calibration curves, and also selects the first calibration curve of the inputted calibration number from the plurality of second calibration curves. Select 2 calibration curve. That is, the control means 10 selects a proper first calibration curve corresponding to the corresponding lot from a plurality of proper first calibration curves based on the identification information, and a plurality of proper second calibration curves. An appropriate second calibration curve corresponding to the corresponding lot is selected from the calibration curve.

  In the blood measurement mode, the control means 10 obtains the blood glucose level based on the photometric value of the photometric unit 4 of the test paper 53 to which blood has adhered, using the selected appropriate first calibration curve. .

  In the test liquid measurement mode, the control means 10 uses the selected appropriate second calibration curve to determine the blood glucose level based on the photometric value of the photometric unit 4 of the test paper 53 to which the test liquid has adhered. Ask for.

  Next, the operation (operation) of the component measuring apparatus 1 will be described based on the flowcharts shown in FIGS. 8 and 9.

  8 and 9 are flowcharts for explaining the operation of the component measuring apparatus shown in FIG. 1 (flow chart showing the control operation of the control means 10).

First, an example of work performed by the user will be briefly described.
The user operates the operation button 31 to turn on the power switch, and attaches the chip 5 to the presser member 47 of the component measuring apparatus 1. The power switch may be automatically turned on when the chip 5 is mounted.

  Further, the user operates the operation members 32 to 34 to turn on the blood measurement mode selection switch or the test liquid measurement mode selection switch to set the blood measurement mode or the test liquid measurement mode. When the blood measurement mode is set, blood is collected with the chip 5. Thereby, the collected blood adheres to the test paper 53. When the test liquid measurement mode is set, the test liquid is collected with the chip 5. As a result, the collected test liquid adheres to the test paper 53.

  Further, the user operates the operation members 32 to 34 to input the calibration number described in the storage container of the chip 5 to be used. Thus, an appropriate first calibration curve corresponding to the corresponding lot is selected, and an appropriate second calibration curve corresponding to the corresponding lot is selected.

  In addition, the user operates the operation member 32 to turn on the measurement switch. Thereby, as described above, photometry (measurement) is performed by the photometry unit 4, and a blood glucose level is obtained.

  Finally, the user operates the operation button 31 to turn off the power switch. The order of the user's work can be changed as appropriate, and a part of the work can be omitted.

Next, the operation (operation) of the component measuring apparatus 1 will be described.
First, it is determined whether or not the power switch is turned on (step S101). If the power switch is turned on, the blood measurement mode is set (step S102). The usage frequency is overwhelmingly higher in the blood measurement mode than in the test liquid measurement mode, so that it is possible to save the user from manually setting the blood measurement mode.

  Next, characters, symbols, figures and the like indicating that the blood measurement mode is set are displayed on the liquid crystal display device 9 (step S103).

  Next, it is determined whether or not the blood measurement mode selection switch is turned on (step S104). If the blood measurement mode selection switch is turned on, the process returns to step S102, and step S102 and subsequent steps are executed again. The blood measurement mode selection switch is turned off instantaneously after being turned on.

  In step S104, if the blood measurement mode selection switch is not turned on, it is determined whether or not the test liquid measurement mode selection switch is turned on (step S105). If the test liquid measurement mode selection switch is turned on. Then, the test liquid measurement mode is set (step S106). The test liquid measurement mode selection switch is turned off instantaneously after being turned on.

  Next, characters, symbols, figures and the like indicating that the test liquid measurement mode is set are displayed on the liquid crystal display device 9 (step S107), the process returns to step S104, and step S104 and subsequent steps are executed again.

  In step S105, when the test liquid measurement mode selection switch is not turned on, the first calibration curve of the input calibration number is selected from the plurality of first calibration curves, and the plurality of second calibration curves are selected. From the calibration curve, the second calibration curve of the input calibration number is selected (step S108). In step S108, the first calibration curve and the second calibration curve having the latest input calibration number are selected.

  Next, it is determined whether or not the measurement switch is turned on (step S109). If the measurement switch is not turned on, it is determined whether or not the power switch is turned off (step S110), and if the power switch is not turned off. Returns to step S104, executes step S104 and subsequent steps again, and terminates the program when the power switch is turned off.

  If the measurement switch is turned on in step S109, photometry (measurement) is performed by the photometry unit 4 as described above (step S111). The measurement switch is turned off instantaneously after being turned on.

  Next, it is determined whether or not the current mode is the blood measurement mode (step S112). If the current mode is the blood measurement mode, photometry of the photometry unit 4 is performed using the selected first calibration curve. Based on the value, a blood glucose level is obtained (step S113).

  Next, the obtained blood glucose level is displayed on the liquid crystal display device 9 (step S114), the process returns to step S104, and step S104 and subsequent steps are executed again.

  On the other hand, if the test liquid measurement mode is set in step S112, the blood glucose level is obtained based on the photometric value of the photometric unit 4 using the selected second calibration curve (step S115).

  Next, it is determined whether or not the obtained blood glucose level is within an allowable range (step S116). If the obtained blood glucose level is within the allowable range, the obtained blood glucose level and the blood glucose level are within the allowable range. For example, “OK” is displayed (step S117), the process returns to step S102, and step S102 and subsequent steps are executed again. Next, since the user normally measures the blood glucose level in the blood measurement mode, since the blood measurement mode is automatically set in step S102, the user automatically switches to the blood measurement mode. It is possible to save the user from manually setting the blood measurement mode.

  In step S116, if the determined blood glucose level is outside the allowable range, the liquid crystal display device 9 indicates that the determined blood glucose level is outside the allowable range, for example, “NG”. Is displayed (step S118), the process returns to step S104, and step S104 and subsequent steps are executed again. In this case, since the test liquid measurement mode is maintained without switching to the blood measurement mode, the user again performs measurement in the test liquid measurement mode without performing the operation of setting the test liquid measurement mode. And the measurement accuracy of the measurement system can be confirmed.

  As described above, according to the component measuring apparatus 1, in the blood measurement mode, the blood glucose level is obtained using an appropriate first calibration curve corresponding to the corresponding lot, and in the test liquid measurement mode, Since the blood glucose level is obtained using an appropriate second calibration curve corresponding to the lot to be measured, the blood glucose level can be accurately measured, and the test paper 53 of the chip 5 can be obtained with an allowable range in the measurement of the test liquid. Without being changed for each lot (allowable range can be fixed to a certain range), it is possible to accurately determine whether the measurement system configured by the component measuring apparatus 1 and the chip 5 is good or bad.

  That is, in particular, an operation (step) for setting a different allowable range for each lot in which the test paper 53 of the chip 5 is obtained for the test liquid and printing the allowable range on each storage container of the corresponding chip 5 each time. It becomes unnecessary. In addition, the tolerance range can be set narrower than that in which a wide tolerance range is set in consideration of variation among lots, so that the accuracy of the measurement system using the test liquid can be confirmed more precisely. Thereby, a sense of security can be given to the user, and the measurement accuracy of the measurement system can be reliably managed.

  In the present invention, in the flowcharts shown in FIGS. 8 and 9, for example, step S108 may be provided at another position.

  Moreover, in this invention, after performing step S118, you may return to step S102. That is, when the measurement in the test liquid measurement mode is completed, regardless of the result (whether a value within the allowable range is obtained or a value outside the allowable range is obtained), the blood measurement mode is used. It may be configured to switch to.

  In the present embodiment, the data storage unit 13 stores a plurality of appropriate first calibration curves and a plurality of appropriate second calibration curves. From these, a predetermined first calibration curve is stored. The predetermined second calibration curve is selected, but the present invention is not limited to this, and for example, it may be configured as in the following (1) or (2).

(Configuration 1)
One first calibration curve is stored in the data storage unit 13. Then, for each storage container in which a plurality of chips 5 each having test paper 53 obtained from the same lot are stored, the first calibration curve stored in the data storage unit 13 indicates the chip 5 in the storage container. First correction information (correction information for blood) for correcting the first calibration curve so as to be an appropriate first calibration curve according to the characteristics of the test paper 53, and stored in the data storage unit 13. Second correction information (test solution) for correcting the first calibration curve so that the first calibration curve is an appropriate second calibration curve according to the characteristics of the test paper 53 of the chip 5 in the storage container. Correction information) is set respectively. That is, a proper first calibration curve and a proper second calibration curve are set for each lot of the plurality of lots, and a plurality of first correction information corresponding to the plurality of lots A plurality of pieces of second correction information corresponding to a plurality of lots are stored in the data storage unit 13.

(Configuration 2)
The data storage unit 13 stores one first calibration curve and one second calibration curve. Then, for each storage container in which a plurality of chips 5 each having test paper 53 obtained from the same lot are stored, the first calibration curve stored in the data storage unit 13 indicates the chip 5 in the storage container. First correction information (correction information for blood) for correcting the first calibration curve so as to be an appropriate first calibration curve according to the characteristics of the test paper 53, and stored in the data storage unit 13. Second correction information (test solution) for correcting the second calibration curve so that the second calibration curve is an appropriate second calibration curve according to the characteristics of the test paper 53 of the chip 5 in the storage container. Correction information) is set respectively. That is, an appropriate first calibration curve and an appropriate second calibration curve are set for each lot of the plurality of lots, and a plurality of first correction information corresponding to the plurality of lots A plurality of pieces of second correction information corresponding to a plurality of lots are stored in the data storage unit 13.

  In addition, as 1st correction information and 2nd correction information, when calculating | requiring a blood glucose level, for example using the calibration curve before correction, respectively, when it becomes a value smaller than a proper value by a predetermined value, for example When the predetermined value is added and becomes a value larger than the appropriate value by a predetermined value, an arithmetic expression for subtracting the predetermined value may be used.

  In addition, each first correction information and each second correction information stored in the data storage unit 13 includes a calibration number (identification for specifying the first correction information and the second correction information, respectively). Information) is assigned.

  On the other hand, each storage container of the chip 5 has a calibration number (identification information) for identifying the first correction information corresponding to the corresponding lot and the second correction information corresponding to the corresponding lot. (Displayed).

  When the user inputs the calibration number described in the storage container of the chip 5 to be used by operating the operation members 32 to 34, the control means 10 receives the calibration input from the plurality of first correction information. First correction information of a number is selected, and second correction information of an input calibration number is selected from a plurality of second correction information. That is, the control means 10 selects the first correction information corresponding to the corresponding lot from the plurality of first correction information based on the identification information, and the corresponding one from the plurality of second correction information. The second correction information corresponding to the lot is selected. Then, the appropriate first calibration curve after correction based on the selected first correction information and the appropriate second calibration curve after correction based on the selected second correction information are stored in the data storage unit 13. Is done.

  In the blood measurement mode, the control means 10 uses the appropriate first calibration curve after the correction based on the selected first correction information to set the photometric value of the photometric unit 4 of the test paper 53 to which blood has adhered. Based on this, the blood sugar level is obtained.

  Further, in the test liquid measurement mode, the control means 10 uses the appropriate second calibration curve after the correction based on the selected second correction information, and the photometric unit 4 of the test paper 53 to which the test liquid has adhered. The blood glucose level is determined based on the photometric value.

  In the present invention, an appropriate first calibration curve corresponding to a plurality of lots and a plurality of second correction information corresponding to a plurality of lots may be stored in the data storage unit 13.

  In the present invention, even if a plurality of first correction information corresponding to a plurality of lots and a plurality of appropriate second calibration curves corresponding to a plurality of lots are stored in the data storage unit 13. Good.

  It should be noted that each of the above-described modifications can be applied to each embodiment described later as it is or with some modifications. In the following description of each embodiment, descriptions of these modified examples are omitted or briefly described.

<Second Embodiment>
Next, a second embodiment of the component measuring apparatus of the present invention will be described.

  FIG. 10 is a flowchart (flow chart showing the control operation of the control means 10) for explaining the operation of the second embodiment of the component measuring apparatus of the present invention.

  Hereinafter, the component measuring apparatus 1 according to the second embodiment will be described focusing on the differences from the first embodiment described above, and description of similar matters will be omitted.

  The component measuring apparatus 1 of the second embodiment is different from that described above except that it is configured to be automatically set to one of a blood measurement mode and a test liquid measurement mode. This is the same as the first embodiment.

  That is, in the component measuring apparatus 1 of the second embodiment, the change amount (change rate) per unit time of the output value (photometric value) (measured value) from the light receiving element 42 of the photometric unit 4 is a test in which blood adheres. Since the measurement is different between the case where the paper 53 is measured and the case where the test paper 53 to which the test liquid is attached is measured, the difference between the test paper 53 and the test paper 53 to which the test liquid is attached is used. Are determined, and according to the result, either the blood measurement mode or the test liquid measurement mode is set. When the test paper 53 with blood attached is measured, the blood measurement mode is set. When the test paper 53 with the test liquid attached is measured, the test liquid measurement mode is set.

  The method for determining which of the test paper 53 to which the blood has adhered and the test paper 53 to which the test liquid has been attached is not limited to this, and for example, the color of the test paper 53 to which the liquid has adhered is determined. Measurement (recognition) may be performed and the determination may be made using the difference in color.

  Next, the operation (operation) of the component measuring apparatus 1 will be described based on the flowchart shown in FIG.

  First, it is determined whether or not the power switch is turned on (step S201). If the power switch is turned on, the first calibration curve with the input calibration number is selected from the plurality of first calibration curves. Further, the second calibration curve having the inputted calibration number is selected from the plurality of second calibration curves (step S202). In step S202, the first calibration curve and the second calibration curve having the latest input calibration number are selected.

  Next, it is determined whether or not the measurement switch is turned on (step S203). If the measurement switch is not turned on, it is determined whether or not the power switch is turned off (step S204), and the power switch is not turned off. Returns to step S202, executes step S202 and subsequent steps again, and terminates the program when the power switch is turned off.

  If the measurement switch is turned on in step S203, the photometry unit 4 performs photometry (measurement) as described above (step S205). The measurement switch is turned off instantaneously after being turned on.

  Next, it is determined whether or not the test paper 53 to which blood has adhered has been measured (step S206). If it is determined that the test paper 53 to which blood has adhered has been measured, the blood measurement mode is set (step S207). .

  Next, using the selected first calibration curve, a blood glucose level is obtained based on the photometric value of the photometric unit 4 (step S208).

  Next, the obtained blood glucose level, characters, symbols, and the like indicating that the blood measurement mode is set are displayed on the liquid crystal display device 9 (step S209), the process returns to step S202, and step S202 and subsequent steps are executed again. .

  On the other hand, if it is determined in step S206 that the test paper 53 to which the test liquid has adhered is measured, the test liquid measurement mode is set (step S210).

  Next, using the selected second calibration curve, a blood sugar level is obtained based on the photometric value of the photometric unit 4 (step S211).

  Next, it is determined whether or not the obtained blood glucose level is within an allowable range (step S212). If the obtained blood glucose level is within the allowable range, the liquid crystal display device 9 determines the determined blood glucose level and the blood glucose level is within the allowable range. For example, “OK” and characters, symbols, graphics, and the like indicating that the blood measurement mode is set are displayed (step S213), the process returns to step S202, and step S202 and subsequent steps are executed again.

  In step S212, when the obtained blood glucose level is out of the allowable range, the liquid crystal display device 9 indicates that the obtained blood glucose level is out of the allowable range, for example “NG”. Then, characters, symbols, figures and the like indicating that the test liquid measurement mode is set are displayed (step S214), the process returns to step S202, and step S202 and subsequent steps are executed again.

  According to this component measuring apparatus 1, the same effect as the first embodiment described above can be obtained.

  In the component measuring apparatus 1, when the user does not need to manually perform the operation of setting the blood measurement mode or the test liquid measurement mode, and the test paper 53 to which blood has adhered is measured, the blood measurement mode is set. When the test paper 53 to which the test liquid is attached is measured, the test liquid measurement mode is configured to be automatically set, so that the user's trouble can be saved. Setting different modes can be prevented.

  The second embodiment can also be applied to each embodiment described later.

<Third Embodiment>
Next, a third embodiment of the component measuring apparatus of the present invention will be described.

  FIG. 11 is a block diagram showing a third embodiment of the component measuring apparatus of the present invention.

  Hereinafter, the component measuring apparatus 1 according to the third embodiment will be described focusing on the differences from the first embodiment described above, and description of similar matters will be omitted.

  In the component measuring apparatus 1 according to the third embodiment, each storage container of the chip (test device) 5 or each chip 5 of each storage container is provided with an information carrier such as a barcode that carries information for specifying such as a calibration number. It has been.

  As shown in FIG. 11, the component measuring apparatus 1 has a barcode reader (second reading means) (reading means) 21 for reading information carried by a barcode (information carrier). The barcode reader 21 and the control means 10 are electrically connected, and information read by the barcode reader 21 is input to the control means 10.

  That is, the barcode provided in each storage container or each chip 5 is read by the barcode reader 21, and the information of the calibration number carried by the barcode is input to the control means 10.

  In addition, the present embodiment can be applied to a component measuring apparatus that can detachably mount a chip cartridge. The configuration in this case will be described below.

  First, a chip cartridge is composed of a plurality of chips 5 and a storage container that stores the plurality of chips 5.

  The component measuring apparatus 1 has a cartridge mounting part (storage container mounting part) for detachably mounting the chip cartridge, and a mechanism for selecting one chip from a plurality of chips for measurement (not shown). ). When the chip cartridge is mounted on the cartridge mounting portion of the component measuring apparatus 1, the barcode provided in the chip cartridge storage container is read by the barcode reader 21, and information on the calibration number carried by the barcode is: Input to the control means 10.

  In another configuration example, when the chip 5 of the chip cartridge mounted on the cartridge mounting portion of the component measuring apparatus 1 is mounted on the chip mounting section of the component measuring apparatus 1, the bar provided on the chip 5 is displayed. The code is read by the bar code reader 21 and the information of the calibration number carried by the bar code is input to the control means 10.

  The information carrier is not limited to a barcode, and may be a two-dimensional code, for example.

  According to this component measuring apparatus 1, the same effect as the first embodiment described above can be obtained.

<Fourth embodiment>
Next, a fourth embodiment of the component measuring apparatus of the present invention will be described.

  FIG. 12 is a block diagram showing a fourth embodiment of the component measuring apparatus of the present invention.

  Hereinafter, the component measuring apparatus 1 according to the fourth embodiment will be described with a focus on the differences from the first embodiment described above, and description of similar matters will be omitted.

  In the component measuring apparatus 1 of the fourth embodiment, an IC memory chip (IC memory card) 24 as a second storage unit is attached to each storage container of the chip (test device) 5.

  The IC memory chip (second storage means) 24 stores an appropriate first calibration curve corresponding to the corresponding lot and an appropriate second calibration curve corresponding to the corresponding lot.

  As shown in FIG. 12, the component measuring apparatus 1 includes an IC memory mounting portion (not shown) on which the IC memory chip 24 is detachably mounted, and an IC memory chip 24 mounted on the IC memory mounting portion. At this time, a connector 23 to which the terminals of the IC memory chip 24 are electrically connected, and a reading unit (first reading means) that is electrically connected to the connector 23 and reads information stored in the IC memory chip 24 (first reading means) ( Reading means) 22. The reading unit 22 and the control unit 10 are electrically connected, and information read by the reading unit 22 is input to the control unit 10.

  That is, with the IC memory chip 24 mounted in the IC memory mounting portion and the terminals of the IC memory chip 24 electrically connected to the connector 23, the appropriate lot corresponding to the corresponding lot stored in the IC memory chip is obtained. Information on the first calibration curve and the second calibration curve is read by the reading unit 22, input to the control means 10, stored in the data storage unit 13, and read from the data storage unit 13 when necessary.

  As described in the first embodiment, one first calibration curve, or one first calibration curve and one second calibration curve are stored in the data storage unit 13. The first correction information corresponding to the corresponding lot and the second correction information corresponding to the corresponding lot may be stored in the IC memory chip 24, and an appropriate first number corresponding to the corresponding lot may be stored. 1 calibration curve and second correction information corresponding to the corresponding lot may be stored, and the first correction information corresponding to the corresponding lot and the appropriate second corresponding to the corresponding lot. A calibration curve may be stored.

  According to this component measuring apparatus 1, the same effect as the first embodiment described above can be obtained.

  The component measuring apparatus of the present invention has been described based on the illustrated embodiment. However, the present invention is not limited to this, and the configuration of each part is replaced with an arbitrary configuration having a similar function. can do. In addition, any other component may be added to the present invention.

  Further, the present invention may be a combination of any two or more configurations (features) of the above embodiments.

  In the above-described embodiment, blood has been described as a sample. However, the sample is not limited to this, and may be a body fluid such as urine, lymph, spinal fluid, saliva, or a diluted solution or concentrated solution thereof. .

  In addition, the measurement target component (predetermined component) is not limited to glucose (blood glucose level), but, for example, cholesterol, uric acid, creatinine, lactic acid, hemoglobin (occult blood), various alcohols, various sugars, various proteins, various vitamins In addition, various inorganic ions such as sodium may be used.

  Moreover, although the said embodiment demonstrated the component measurement apparatus which mounts and uses a bottomed cylindrical chip | tip (test tool) provided with a test paper, the component measurement apparatus of this invention is small piece, flat plate shape ( A test device having another configuration (form) such as a plate shape, a sheet shape, or a stick shape may be used.

  Moreover, in the said embodiment, although a test device and a component measuring apparatus are a colorimetric type (system to measure optically), in this invention, it is not restricted to this system, For example, an electrode type (to a test piece) A method of measuring a current flowing through a test piece when a voltage is applied between two electrodes in contact with each other) may be used.

  According to the present invention, each storage container in which a plurality of chips (test tools) obtained from the same lot are stored is used in the sample measurement mode, and an appropriate second test is performed according to the characteristics of the test tool in the storage container. One calibration curve or first correction information and an appropriate second calibration curve or second correction information used in the test liquid measurement mode and according to the characteristics of the test tool in the storage container are set. Therefore, it is possible to accurately measure the amount of the predetermined component in the specimen, and the allowable range in the measurement of the test liquid is not changed for each lot from which the test device is obtained (the allowable range is fixed to a certain range). The measurement accuracy of the measurement system composed of the component measuring device and the test device can be accurately determined. That is, in particular, for the test liquid, a different allowable range is set for each lot from which the test device is obtained, and an operation (process) for printing the allowable range on each storage container of the corresponding test device is not required. Further, the allowable range can be narrowed compared to the case where the variation is set for each lot, and the accuracy of the measurement system using the test liquid can be confirmed more appropriately. Thereby, management of the measurement accuracy of a measurement system can be performed reliably. Therefore, it has industrial applicability.

Claims (8)

Specimen measurement mode for obtaining a value indicating the amount of a predetermined component in the sample, and the amount of the predetermined component in the sample by measuring a test liquid in which a value corresponding to the amount of the predetermined component in the sample is set to a predetermined value A component measurement apparatus having a test liquid measurement mode for obtaining a value corresponding to
A measuring unit that measures the amount of the predetermined component in the specimen using a test tool that can be detachably attached to the component measuring device;
Based on the first calibration curve used to determine the value indicating the amount of the predetermined component in the sample based on the measurement result of the sample by the measurement unit, and based on the measurement result of the test solution by the measurement unit, First storage means for storing a second calibration curve used for obtaining a value corresponding to the amount of the predetermined component in the specimen;
A value indicating the amount of the predetermined component in the sample is obtained using the first calibration curve, and a value corresponding to the amount of the predetermined component in the sample in the test solution is obtained using the second calibration curve. An analysis means for obtaining a value,
For each of a plurality of test tools in the same lot, an appropriate first calibration curve corresponding to the characteristics of the test tools in the same lot, or the first calibration curve stored in the first storage means is the appropriate First correction information for correcting the first calibration curve so as to be a first calibration curve, and a second calibration curve appropriate for the characteristics of the test tool of the same lot, or the first calibration curve Second correction information for correcting the first or second calibration curve is set so that the first or second calibration curve stored in the storage means becomes the appropriate second calibration curve. Has been
In the sample measurement mode, the analysis means uses the appropriate first calibration curve or the appropriate first calibration curve after the correction by the first correction information, and the measurement unit of the sample. Based on the measurement result by, obtain a value indicating the amount of the predetermined component in the sample,
In the test liquid measurement mode, the analysis means uses the appropriate second calibration curve or the appropriate second calibration curve after the correction by the second correction information, to A component measuring apparatus configured to obtain a value corresponding to an amount of a predetermined component in the test liquid in the test solution based on a measurement result by a measuring unit. For each storage container that stores a plurality of test devices of the same lot, the appropriate first calibration curve or the first correction information corresponding to the corresponding lot, and the appropriate second corresponding to the corresponding lot. A second storage means for storing the calibration curve or the second correction information is attached,
The component measuring apparatus according to claim 1, further comprising a reading unit that reads information stored in the second storage unit.   The plurality of appropriate first calibration curves or a plurality of the first correction information corresponding to a plurality of lots, and the plurality of appropriate second calibration curves or the plurality of second corresponding to the plurality of lots. The component measurement apparatus according to claim 1, wherein the correction information is stored in the first storage unit. In each storage container storing a plurality of test devices of the same lot, the appropriate first calibration curve or the first correction information corresponding to the corresponding lot, and the appropriate Information for specifying that specifies the second calibration curve or the second correction information is displayed,
Input means for inputting the identifying information;
Based on the specifying information, the appropriate first calibration curve or the first correction information corresponding to the corresponding lot from the plurality of appropriate first calibration curves or the plurality of first correction information. And selecting the appropriate second calibration curve or the second correction information corresponding to the corresponding lot from the plurality of appropriate second calibration curves or the plurality of second correction information. The component measuring apparatus according to claim 3, further comprising a selection unit. Each storage container that stores the plurality of test tools of the same lot or each test tool of each storage container, respectively, the appropriate first calibration curve or the first correction information corresponding to the corresponding lot, An information carrier that carries information for specifying the appropriate second calibration curve corresponding to the corresponding lot or the second correction information is provided;
Reading means for reading information carried by the information carrier;
Based on the specifying information, the appropriate first calibration curve or the first correction information corresponding to the corresponding lot from the plurality of appropriate first calibration curves or the plurality of first correction information. And selecting the appropriate second calibration curve or the second correction information corresponding to the corresponding lot from the plurality of appropriate second calibration curves or the plurality of second correction information. The component measuring apparatus according to claim 3, further comprising a selection unit.   The component measurement apparatus according to claim 1, wherein the component measurement apparatus is configured to switch to the sample measurement mode when measurement in the test liquid measurement mode is completed.   The component measuring apparatus according to claim 1, wherein when the measurement in the test liquid measurement mode is completed, and as a result, a value within an allowable range is obtained, the component measurement mode is switched to the sample measurement mode. The test liquid measurement mode is a mode in which the obtained value is compared with a preset allowable range to determine whether the measurement system configured by the component measurement device and the test tool is good or bad in measurement accuracy. The component measuring apparatus according to claim 1.

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