JP2013024797A - Analyzer and analysis method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide technique for allowing a user to appropriately recognize the deterioration state of an analysis test piece to be used for analysis processing concerning an analyzer and analysis method for analyzing a sample by using the analysis test piece.SOLUTION: An analyzer includes: a test piece storage part for storing an analysis test piece; a sample drop dispensing part for dispensing a drop of a specimen onto a reagent pad formed on the analysis test piece; and optical characteristic value measurement means for measuring the optical characteristic value of the reagent pad. The analyzer also includes: deterioration discrimination means for discriminating the deterioration state of the analysis test piece on the basis of the optical characteristic value of the reagent pad where the drop of the specimen is not dispensed by the sample drop dispensing part, which is measured by the optical characteristic value measurement means; and notification means for notifying a user of the deterioration state of the analysis test piece discriminated by the deterioration discrimination means.

Description

  The present invention relates to an analysis apparatus and an analysis method.

  Conventionally, an analyzer (for example, refer to Patent Document 1) for analyzing a sample (specimen) such as urine or blood using an analysis test piece is known. In this type of analyzer, a plurality of test specimens for analysis are held in a hopper-shaped or box-shaped test specimen container, and the analytical test specimens are tested using a transfer means when performing an analysis process. One piece is taken out one by one. The taken-out analytical test specimen is inserted into the sample container and immersed in the specimen, or the specimen is spotted on the analytical specimen using a spotting (dispensing) device. Used in After the sample is spotted and added to the analytical test piece in this way, for example, the color tone change of the analytical test piece is measured using an optical technique, and the concentration of a specific component is determined based on the measurement result. Is judged.

  Here, when the test specimen for analysis is exposed to a humid environment for a long period of time, the reagent applied to the reagent part (reagent pad) may change in quality, leading to a decrease in quality (deterioration). An open / close lid for defining the storage space from the external space, for example, so that the storage space for the analysis test strip in the test strip storage section has an atmosphere suitable for preventing deterioration (deterioration) of the quality of the analysis test strip. Or a desiccant may be installed in the storage space. However, even if such measures are taken, it is not easy to ensure sufficient sealing and airtightness of the accommodation space.

  For this reason, normally, a sealed storage container that can store analysis specimens in a sealed state is attached to the analyzer, and excess analysis specimens are stored in a sealed container each time an analysis process is completed. In many cases, the instruction of the content to be performed is described in the instruction manual of the analyzer. For example, a user (user) who observes the description in this instruction manual, if the test specimen for analysis remains in the test specimen container when the main power of the analyzer is turned off, Store excess in sealed containers. As a result, even if the operation stop period until the main power of the analyzer is turned on is long, the test specimen for analysis is not stored in the sealed storage container in the analyzer during the operation stop period. As long as it is stored, the test specimen for analysis does not deteriorate.

JP 2000-32270 A JP 2009-229232 A

  However, when the operation of the analyzer is stopped, it is usually up to the user to actually store the analytical test strip remaining in the test strip container in the sealed storage container. Therefore, it cannot be denied that there is a possibility that the test specimen for analysis is left (leaved) in the test specimen container during the operation stop period of the analyzer. Also, this type of analyzer usually does not monitor the timing and number of the test pieces for analysis put into the test piece container. From the above, when the analysis process is resumed by the analyzer, there is a possibility that a so-called deteriorated analysis test piece such as a quality drop may be used for the analysis process. As a result, there is a possibility that the analysis error of the sample is likely to occur, or that the reliability of the analysis result is deteriorated.

  The present invention has been made in view of the above problems, and in an analysis apparatus and an analysis method for analyzing a sample using an analytical test piece, the deterioration state of the analytical test piece used for the analysis process is appropriately determined by the user. It aims at providing the technology which can be made to recognize.

  An analyzer provided by the first aspect of the present invention includes a test strip container for storing an analytical test strip, and a sample spot application for spotting a specimen on a reagent pad formed on the analytical test strip. And an optical characteristic value measuring means for measuring an optical characteristic value of the reagent pad, wherein the sample spotting part measured by the optical characteristic value measuring means is spotted on the specimen. A deterioration determining means for determining the deterioration state of the analytical test piece based on the optical characteristic value of the reagent pad, and a notification means for informing the user of the deterioration state of the analytical test piece determined by the deterioration determining means. And comprising.

  Preferably, the optical characteristic value measuring unit includes two light emitting units that emit light having different wavelengths, and the deterioration determining unit determines based on the optical characteristic values of the two light emitting units. .

  Preferably, one of the two light emitting means emits main light in a wavelength range in which an optical characteristic value changes due to deterioration of the reagent pad, and the other of the two light emitting means has an optical characteristic value due to deterioration of the reagent pad. A reference light whose wavelength range is smaller than that of the main light is emitted.

  Preferably, the reagent pad is for analyzing glucose in urine.

  Preferably, the reagent pad is for analyzing the specific gravity of urine.

  Preferably, the optical characteristic value measuring unit further measures an optical characteristic value of a reference pad formed on the test specimen for analysis, and the deterioration determining unit is configured to detect the optical characteristic value of the reagent pad and the optical value of the reference pad. The determination is made based on the characteristic value.

  Preferably, the reference pad is white.

  Preferably, a color reaction measurement unit that measures a color reaction of the reagent pad on which the specimen is spotted and also serves as the optical characteristic value measurement unit is provided.

  Preferably, a color reaction measurement unit that measures a color reaction of the reagent pad on which the specimen is spotted and is separate from the optical characteristic value measurement unit is provided.

  Preferably, the optical property value measurement and the deterioration by the optical property value measuring means based on the test piece storage portion for storing the analysis test piece, and the storage period of the analysis test piece in the test piece storage portion Preliminary discriminating means for discriminating whether or not discrimination by the discriminating means is necessary.

  Preferably, the preliminary discriminating means discriminates based on whether or not the storage period of the analytical test piece exceeds the allowable exposure period.

  Preferably, it further comprises an exposure environment measurement means for measuring at least one of humidity and temperature in the test strip container, and the preliminary discrimination means determines whether or not the storage period of the test specimen for analysis exceeds an allowable exposure period. The allowable exposure period is variably set according to the measurement result by the exposure environment measuring means.

  The analysis method provided by the second aspect of the present invention provides an optical characteristic value for measuring an optical characteristic value of a reagent pad in a state where a specimen has not yet been deposited on the reagent pad formed on the test specimen for analysis. A measurement step; a deterioration determination step for determining a deterioration state of the analytical test piece based on the optical characteristic value measured in the optical characteristic value measurement step; and a determination step of the analytical test piece determined by the deterioration determination step. And a notification step of notifying the user of the deterioration state.

  ADVANTAGE OF THE INVENTION According to this invention, in the analyzer which analyzes a sample using an analytical test piece, the technique which can make a user recognize the deterioration condition of the analytical test piece used for an analysis process appropriately is provided. be able to.

1 is a schematic perspective view showing an analyzer in Example 1. FIG. 1 is a configuration block diagram of an analysis apparatus in Embodiment 1. FIG. FIG. 3 is a diagram illustrating an internal structure of an apparatus main body of the analyzer according to the first embodiment. It is a schematic perspective view which shows the test piece in the actual picking example 1. FIG. FIG. 3 is a functional block diagram of an analysis apparatus according to the first embodiment. It is a flowchart figure which shows a test piece quality confirmation control routine. It is a schematic block diagram of the test piece accommodating part in a modification. FIG. 6 is a configuration block diagram of an analysis apparatus according to a second embodiment. 6 is a diagram illustrating an internal structure of an apparatus main body of an analyzer according to Embodiment 2. FIG.

  Hereinafter, exemplary embodiments for carrying out the invention will be described in detail with reference to the drawings. In this embodiment, as an example of the analyzer according to the present invention, a urine qualitative test is performed by analyzing a chemical component in urine (sample) using an analytical test piece (hereinafter simply referred to as “test piece”). A chemical analyzer for this purpose will be described. The urine qualitative test is a test for inspecting the amount of sugar or protein excreted in urine, the presence or absence of occult blood, etc. by measuring a color tone change due to a chemical reaction of a test piece, that is, a color reaction, with an optical device.

  However, the sample to be analyzed in this analyzer is not limited to urine, and for example, blood or other sample components may be analyzed. In the following drawings, parts that are the same as the parts described in the previous drawings are given the same numbers. The description of each embodiment of the analysis apparatus according to the present invention described below also serves as a description of each embodiment of the analysis method according to the present invention. Note that the dimensions, materials, shapes, relative arrangements, and the like of the components described in this embodiment are intended to limit the technical scope of the invention to those unless otherwise specified. is not. In this embodiment, “sample” and “specimen” are used as synonymous terms.

<Example 1>
FIG. 1 is a schematic perspective view showing an analyzer 1 in the present embodiment. FIG. 2 is a configuration block diagram of the analysis apparatus 1 in the present embodiment. FIG. 3 is a diagram illustrating the internal structure of the apparatus main body 11 of the analyzer 1 according to the present embodiment. The apparatus main body 11 is a housing (housing) that accommodates each element constituting the analyzer 1. As shown in these drawings, the analyzer 1 includes an apparatus main body 11, a test piece supply unit 12, a rack installation unit 13, a sample spotting device 14, a Central Processing Unit (hereinafter referred to as “CPU”) 15, and a memory 16. The photometer 17 is mainly provided. Further, the apparatus main body 11 is provided with a display panel 111, an operation switch group 112, and a printer 113.

  The CPU 15 is a central processing unit that controls the analyzer 1 by executing a computer program. The memory 16 has a function of storing computer programs executed by the CPU 15 and data processed by the CPU 15. The memory 16 is, for example, a volatile random access memory (RAM) or a nonvolatile read only memory (ROM). The ROM stores, for example, programs and parameters necessary for the functioning of the analyzer 1 and various calibration curve data. The RAM provides a work area to the CPU 15 and temporarily stores, for example, a part of an operating system (OS) program and application programs to be executed by the CPU 15. The CPU 15 executes various processes according to programs stored in the memory 16.

  As shown in FIG. 2, the analysis apparatus 1 includes an interface 18 that connects the CPU 15 and various devices, a hard disk drive 19, and a recording medium drive device 20. The interface 18 may be a serial interface such as Universal Serial Bus (USB) or a parallel interface such as Peripheral Component Interconnect (PCI). In addition, although CPU15 and each apparatus are connected with the interface 18, you may connect between CPU15 and each apparatus with a different interface. A plurality of interfaces 18 may be bridge-connected.

  The hard disk drive 19 stores a program loaded into the memory 16. The hard disk drive 19 stores data processed by the CPU 15. The recording medium driving device 20 is a driving device such as a Compact Disc (CD), Digital Versatile Disk (DVD), HD-DVD, or Blu-ray Disc. Further, the recording medium driving device 20 may be an input / output device for a card medium having a nonvolatile memory such as a flash memory. The medium driven by the recording medium driving device 20 stores, for example, a computer program installed in the hard disk drive 19 and input data.

  Here, the test piece 2 is demonstrated with reference to FIG. In the test piece 2, a plurality of reagent pads (reagent parts) 22 containing a reagent for reacting with a sample are arranged side by side in the longitudinal direction of the substrate 21 on a strip-shaped substrate 21 shown in FIG. 4. It is a thing. The reagent pad 22 is subjected to spotting (also referred to as “addition”) of urine as a sample by the sample spotting device 14. Further, a reference pad 23 is formed on the test piece 2. The reference pad is made of, for example, a white resin, and changes with time such as discoloration due to moisture absorption are not significantly generated as compared with the reagent pad 22. In this embodiment, the test piece 2 corresponds to the analytical test piece in the present invention. In this figure, for convenience, six reagent pads 22 and one reference pad 23 are arranged on the base material 21. However, the number may be increased or decreased as appropriate.

  A photometric device 17 shown in FIGS. 2 and 3 is an optical system installed inside the apparatus main body 11 and optically measures the color reaction of the test piece 2 described above. In the present embodiment, the photometric device 17 is used to measure the reflectance of the reagent pad 22 and the reference pad 23 in a state where a sample has not yet been spotted. The photometric device 17 is an example of the optical characteristic value measuring means referred to in the present invention. The reflectance is an example of an optical characteristic value that is a measurement item of the optical characteristic value measuring means of the present invention, and the optical characteristic value is not limited to the reflectance. The optical characteristic value referred to in the present invention is a characteristic value that can be indicated when the measurement object receives light, and is a concept that includes, for example, transmittance and absorption in addition to reflectance.

  The operation switch group 112 is a variety of switches for the user (user) to operate the analyzer 1. For example, a power switch for switching on / off the main power supply of the analyzer 1, sample analysis processing (measurement processing) For example, a measurement start switch, and a print switch for causing the printer 113 to print the analysis result of the sample by the analyzer 1.

  The display panel 111 includes, for example, an LCD (liquid crystal display), a light emitting diode, and the like, and is controlled by the CPU 15 to display various information. Of the operation switch group 112, for example, when a measurement start switch is pressed by a user, for example, the above measurement items are measured on the sample, and an analysis result (inspection result) obtained based on the measurement result is displayed on the display panel 111. It is displayed. In addition, the display panel 111 can display data processed by the CPU 15 or data stored in the memory. When the above-described print switch is pressed, the sample analysis result is printed out by the printer 113, for example, on a recording sheet.

  The rack installation unit 13 is provided with the sample rack 131 shown in FIG. The sample rack 131 is a rack for standing and holding a plurality of sample containers 132 containing urine as a sample (represented by a symbol U in the figure).

  The sample spotting device 14 includes a nozzle 141 and a nozzle driving device 142 that drives the nozzle 141 in the vertical direction and the horizontal direction in the apparatus main body 11. The nozzle driving device 142 can be constituted by, for example, an actuator or a circulation driving belt. When the urine is sucked by the nozzle 141, the CPU 15 controls the nozzle driving device 142 to move the nozzle 141 to a position above the sample container 132 in which urine is stored, and then lowers the nozzle 141. Then, the CPU 15 drives a pump (not shown) to cause the nozzle 141 to suck urine in the sample container 132. Here, at the position P1 in the figure, the test piece 2 is supplied one by one by a test piece supply unit 12 described below.

  When the color reaction of the sample using the test piece 2 is optically measured, a predetermined amount of urine is spotted by the nozzle 141 on the reagent pad 22 of the test piece 2 set at the position P1. Such spotting operation is repeated by the number of reagent pads 22 installed on the test piece 2, and the spotting process is completed. After the sample spotting process on the test piece 2 is completed, the nozzle 141 is cleaned using a cleaning liquid (for example, distilled water). Although a detailed description of the configuration for cleaning the nozzle 141 is omitted, a configuration similar to that conventionally known (for example, those described in Patent Documents 1 and 2, etc.) can be used.

  The test strip supply unit 12 stores test strips 2 for use in sample analysis, and transfers (transports and supplies) the stored test strips 2 one by one to the above-described position P1. The test strip supply unit 12 includes a test strip storage unit 121 that stores a plurality of test strips 2, and a rotating drum 122 for taking out the test strips 2 one by one from the test strip storage unit 121. In addition, an opening / closing lid 1211 is provided in the upper opening of the test piece housing part 121. The opening / closing lid 1211 defines (divides) the accommodation space S1 of the test piece 2 in the test piece accommodation portion 121 with respect to the external space S2. In addition, a desiccant installation part (not shown) for installing a desiccant is provided in the test piece container 121 as necessary.

  The rotating drum 122 constituting the test piece supply unit 12 has a concave portion 1221 that allows only one test piece 2 to be fitted on the outer peripheral surface thereof. Then, the test piece 2 fitted in the recess 1221 by the rotation of the rotating drum 122 is discharged to the outside of the test piece storage unit 121 and then transferred to the position P1 by a transfer device (not shown). In the vicinity of the position P1, a test piece detection sensor 124 for detecting the test piece 2 transferred to the position P1 is provided. The test piece detection sensor 124 is electrically connected to the CPU 15 via the interface 18, and an output signal thereof is input to the CPU 15 as needed.

  FIG. 5 is a functional block diagram of the analyzer 1 in the present embodiment. Each functional unit (31 to 38, 40) illustrated in FIG. 5 can be realized by a computer including the CPU 15, the memory 16, and the like, a program executed on the computer, and the like. The test strip supply control unit 31 shown in FIG. 5 performs control related to the rotation operation of the rotary drum 122 and control related to a transfer device for transferring the test strip 2 to the position P1. Further, the spotting device control unit 32 executes a nozzle driving device 142 for transferring the nozzle 141, control related to spotting of the sample on the reagent pad 22 of the test piece 2, and the like.

  The photometric device 17 shown in FIG. 3 receives the reflected light when the reagent pad 22 of the test piece 2 on which the sample is spotted by the sample spotting device 14 is irradiated with light. This is an apparatus for obtaining information according to the degree of color development (color reaction). The photometric device 17 includes light emitting units 171a and 171b and a light receiving unit 172. The light emitting units 171a and 171b can emit light having a specific peak wavelength, for example, and may be a light-emitting diode (LED), a semiconductor laser, or the like. In the present embodiment, the light emitting unit 171a emits main light as referred to in the present invention, and emits light having a peak wavelength in the vicinity of 565 nm, for example. The light emitting unit 171b emits the reference light referred to in the present invention, and emits light having a peak wavelength in the vicinity of 760 nm, for example. On the other hand, the light receiving unit 172 is for receiving light reflected from each reagent pad 22 on which a sample is spotted, and may be, for example, a photodiode. The photometric device control unit 33 shown in FIG. 5 executes control related to irradiation of light from the light emitting units 171 a and 171 b and reception of reflected light by the light receiving unit 172 in the photometric device 17.

  The measurement unit 34 acquires the light reception result in the light receiving unit 172. The measuring unit 34 then selects a specific component (measurement) such as hemoglobin, glucose, or protein contained in the urine as a sample based on the light reception result acquired from the photometric device 17 and the calibration curve data stored in the memory 16. The density of the item component is calculated. The measurement result of each measurement item component is displayed on the display panel 111 and printed out from the printer 113 as necessary. In addition, the measurement unit 34 calculates the reflectance of the reagent pad 22 and the reference pad 23 used for determining the deterioration state of the test piece 2 from the light reception result acquired from the photometry device 17, and this reflectance is stored in, for example, the memory 16. To remember.

  When the test piece 2 is exposed to a humid environment for a long period of time, the reagent applied to the reagent pad 22 may be deteriorated and the quality of the test piece 2 may be deteriorated (hereinafter also referred to as “deterioration”). There is. When the sample analysis process is performed using the test piece 2 thus deteriorated, an analysis error is likely to be caused, and the reliability of the analysis result may be lowered.

  The test piece container 121 of the analyzer 1 has an inner space (accommodation space) S1 of the test piece container 121 such that the upper opening is closed by the opening / closing lid 1211 and the bottom opening is closed by the rotating drum 122. Has a certain degree of hermeticity (airtightness). Therefore, although the accommodation space S1 has an atmosphere in which the test piece 2 is less likely to deteriorate than the external space S2, the test is still performed when the operation stop period during which the operation of the analyzer 1 is stopped extends for a long time. The possibility of deterioration of the piece 2 increases. For this reason, the analyzer unit 1 is provided with a bottle unit 4 as shown in FIG.

  The bottle unit 4 is a sealed storage container that can store the test piece 2 in a sealed state. In the operation stop period in which the operation of the analyzer 1 is stopped, if the test piece 2 is left in the test piece storage unit 121, the test piece 2 described above may be deteriorated. For this reason, the test piece 2 remaining at the end of the analysis process is to be transferred from the test piece storage unit 121 to the bottle unit 4 by the user. Specifically, when the test piece 2 remains in the test piece container 121 at the end of the day of the analysis process, an instruction to store the surplus test piece 2 in the bottle unit 4 is given by the analyzer 1. It is described in the instruction manual.

  Therefore, as long as the user observes the instruction manual, when the analysis process by the analyzer 1 is completed (the power switch is pressed by the operation of the operation switch group 112 by the user, the main power supply of the analyzer 1 is switched off). The test piece 2 remaining in the test piece storage unit 121 at the time is stored in the bottle unit 4 by the user. For this reason, even when the operation stop period extends for a long time, the test piece 2 is not left in the test piece storage unit 121, so that it does not deteriorate. However, since it is left up to the user to actually transfer the surplus test piece 2 to the bottle unit 4 when the analyzer 1 is stopped, the test piece 2 is stored in the test piece storage unit 121 for a long time during the operation stop period. There is no denying the possibility of detention.

  Therefore, the analyzer 1 in this embodiment performs test piece quality confirmation control for confirming whether or not the test piece 2 subjected to the sample analysis process has deteriorated. The test piece quality confirmation control roughly determines the deterioration state of the test piece 2 based on the reflectance of the reagent pad 22 of the test piece 2 on which the sample has not yet been spotted. In addition, this test piece quality confirmation control determines the deterioration state of the test piece 2 by additionally using the accommodation period of the test piece 2 in the test piece accommodation unit 121. Hereinafter, the test piece quality confirmation control will be described in detail. The determination of the deterioration state of the test piece 2 is not limited to the configuration based on the reflectance, and may be performed based on the optical characteristic value referred to in the present invention. As described above, the optical characteristic value is a concept including, for example, the absorptance and transmittance in addition to the reflectance, and is a characteristic value that can be indicated when a certain object receives light.

  As shown in FIG. 5, the analysis device 1 includes a residual state determination unit 35, a period calculation unit 36, a preliminary determination unit 37, a determination unit 40, a notification as functional units realized by a computer including the CPU 15 and the memory 16. A portion 38 is provided. Hereinafter, the processing content in the test piece quality confirmation control executed by the computer of the analyzer 1 will be described with reference to FIG.

  FIG. 6 is a flowchart showing a test piece quality confirmation control routine executed by the computer of the analyzer 1. A program stored in the memory 16 (referred to as a “commodity confirmation program”) is executed by the CPU 15, thereby realizing each process in this flowchart. The trigger for starting this flowchart is, for example, when the analyzer 1 is started, that is, when the main power source of the analyzer 1 is switched from the off state to the on state by pressing the power switch by the user. Each function unit of the analysis apparatus 1 described in FIG. 5 is realized by the CPU 15 cooperating with a quality confirmation program stored in the memory 16.

  In step S101, the test strip supply controller 31 controls the rotation and transfer of the rotating drum 122 so that if the test strip 2 remains in the test strip storage unit 121, the test strip 2 is transferred to the position P1. Drive control of the device (not shown) is performed. Here, if the test piece 2 does not remain in the test piece storage portion 121 (if the storage space S1 of the test piece storage portion 121 is empty), the test piece 2 is not transferred to the position P1. . And if the test piece 2 remains in the test piece accommodating part 121, since the test piece 2 fits into the recessed part 1221 at least when the rotating drum 122 rotates several times, the test piece 2 is transferred to the position P1. Is done.

  Next, in step S102 (residual state determination step), the residual state determination unit 35 acquires an output signal (detection signal) of the test piece detection sensor 124. Then, based on the acquired detection signal, it is determined whether or not the test piece 2 remains (residual) in the test piece storage unit 121. Specifically, for example, a detection signal from the test piece detection sensor 124 is acquired continuously or intermittently over a predetermined determination period (for example, the time required for the rotating drum 122 to rotate several times). When the acquired detection signal is a signal indicating that the test piece 2 is not detected from beginning to end (hereinafter, also referred to as “test piece non-detection signal”), the residual state determination unit 35 includes a test piece storage unit. It is determined that the test piece 2 does not remain in 121 (the test piece 2 in the test piece storage unit 121 is empty), and this routine is temporarily ended. In this case, the computer of the analysis apparatus 1 executes the analysis program (not shown) stored in the memory 16 by the CPU 15 as in the quality confirmation program.

  The analysis program is a program for measuring the color reaction of the test piece 2 with the photometric device 17 and analyzing a specific component contained in urine as a sample. When the analysis program is executed by the computer of the analysis apparatus 1, the CPU 15 causes the test piece supply control unit 31 to transfer the test piece 2 stored in the test piece storage unit 121 to the position P1, and the sample spotting device. 14, a spotting device control unit 32 for spotting a sample on the test piece 2, a photometry device control unit 33 for executing control related to the photometry device 17, and a light reception result from the light receiving unit 172 of the photometry device 17 It functions as a measurement unit 34 that calculates and analyzes the concentration of the component, and performs sample analysis processing.

  When the residual state determination unit 35 acquires an output signal indicating that the test piece 2 has been detected from the test piece detection sensor 124 (hereinafter, also referred to as “test piece residual signal”) in step S102, the test piece It determines with the test piece 2 remaining in the accommodating part 121, and the process of step S103 is performed.

  In step S103 (period calculation step), the period calculation unit 36 calculates the accommodation period of the test piece 2 (hereinafter referred to as “test piece accommodation period”) ΔPoc. In the present embodiment, the elapsed time from the time when the analyzer 1 is most recently stopped (hereinafter referred to as “the most recent operation stop date / time”) to the time when the analyzer 1 is started again (hereinafter referred to as “the most recent start date / time”). The test piece accommodation period ΔPoc was calculated. In the analyzer 1, the time (date and time) when the power switch is operated by the user is recorded in, for example, the hard disk drive 19 of the analyzer 1. Therefore, the CPU 15 can grasp the latest operation stop date and time by reading from the hard disk drive 19 the latest time (date and time) when the power switch is switched from on to off. Similarly, the most recent start date and time can be grasped by reading from the hard disk drive 19 the latest time (date and time) when the power switch is switched from OFF to ON. Then, the period from the most recent operation stop date to the latest activation date can be calculated as the test piece accommodation period ΔPoc. When the process of this step is completed, the process of step S104 is executed.

  In step S104 (preliminary determination step), the preliminary determination unit 37 determines the deterioration state of the test piece 2 based on the test piece accommodation period ΔPoc calculated in step S103 (period calculation step). Here, the preliminary determination unit 37 preliminarily determines the deterioration state of the test piece 2 based on whether or not the test piece accommodation period ΔPoc exceeds the allowable exposure period ΔPoca. This allowable exposure period ΔPoca is the longest period in which the test piece 2 can be maintained in a usable state without any problem in analysis accuracy in the accommodation space S1 of the test piece accommodation unit 121, and the test piece 2 is deteriorated. This is a preliminary determination reference value set for the test piece accommodation period ΔPoc for determining whether or not the test piece is contained. An appropriate value (for example, about 3 to 5 days) as the allowable exposure period ΔPoca may be obtained in advance based on an empirical rule such as an experiment.

  In this step, the preliminary determination unit 37 determines whether or not the test piece accommodation period ΔPoc exceeds the allowable exposure period ΔPoca. And the preliminary | backup discrimination | determination part 37 preliminarily discriminate | determines the deterioration condition of the test piece 2 based on whether the test piece accommodation period (DELTA) Poc exceeds the allowable exposure period (DELTA) Poca. Specifically, when it is determined that the test piece accommodation period ΔPoc exceeds the allowable exposure period ΔPoca, the preliminary determination unit 37 may have the test piece 2 deteriorated (or deteriorated). The process of step S105 is executed. On the other hand, when it is determined that the test piece accommodation period ΔPoc is within the allowable exposure period ΔPoca, it is determined that the test piece 2 is normal (that is, the quality has not deteriorated). In this case, this routine is once ended, and the above-described analysis program is executed.

  In step S105 (reflectance measurement step), the CPU 15 performs photometry for controlling the test strip supply control unit 31 and the photometry device 17 that transfer the test strip 2 stored in the test strip storage unit 121 to the position P1. It functions as the measurement unit 34 that acquires the light reception result from the device control unit 33 and the light receiving unit 172 of the photometry device 17 and measures the reflectance of the reagent pad 22 (and the reference pad 23).

In this step, the sample is not spotted on the test piece 2 transferred to the position P1. In this state, the following photometric processing is performed. First, the main light (peak wavelength: 565 nm) from the light emitting means 171 a is irradiated onto the reagent pad 22, and the reflected light is received by the light receiving unit 172. The light reception result of the light receiving unit 172 at this time is stored in the memory 16 as the reflectance λa ₅₆₅ of the main light of the reagent pad 22. In addition, the reference light (peak wavelength: 760 nm) from the light emitting unit 171 b is irradiated onto the reagent pad 22, and the reflected light is received by the light receiving unit 172. The light reception result of the light receiving unit 172 at this time is stored in the memory 16 as the reference light reflectance λa ₇₆₀ of the reagent pad 22. Next, the main light from the light emitting means 171 a is irradiated onto the reference pad 23, and the reflected light is received by the light receiving unit 172. The light reception result of the light receiving unit 172 at this time is stored in the memory 16 as the reflectance λr ₅₆₅ of the main light of the reference pad 23. Further, the reference light from the light emitting means 171 b is irradiated onto the reference pad 23, and the reflected light is received by the light receiving unit 172. The light reception result of the light receiving unit 172 at this time is stored in the memory 16 as the reference light reflectance λr ₇₆₀ of the reference pad 23. The reagent pad 22 which is the target of reflectance measurement in this step is for measuring glucose in urine, or for measuring the specific gravity of urine, for example. When the process of this step is completed, the process of step S106 is executed.

In step S106 (deterioration determination step), the determination unit 40 determines the deterioration state of the test piece 2 using the reflectances λa ₅₆₅ , λa ₇₆₀ , λr ₅₆₅ , and λr ₇₆₀ measured in step S105. In the present embodiment, the determination unit 40 calculates the reflectance index Id using Equation 1.

The reagent pad 22 is altered with time by absorbing moisture. The above-described pad for measuring glucose or specific gravity tends to have a low reflectance due to alteration. Further, in these reagent pads 22, a change in reflectance with respect to light having a wavelength of about 565 nm (yellowish green light) is remarkable. On the other hand, the reference pad 23 made of a white resin shows little change with time. For this reason, when deterioration due to a change with time progresses, the reflectance λa ₅₆₅ when the reagent pad 22 is irradiated with main light (peak wavelength: 565 nm) is considered to be the lowest. Dividing by .lambda.r ₅₆₅ on the reflected light when irradiated with the reflectance [lambda] a ₅₆₅ the same primary light to the reference pad 23, for example in order to light quantity change of the light emitting portion 171a to cancel the effect on the reflectance measurements is there. The reason why the reflectance λa ₇₆₀ is divided by the reflectance λr ₇₆₀ is also to cancel the influence of the light amount change of the light emitting portion 171b. The index Id is obtained by dividing the first term for the main light by the second term for the reference light. As a result, the index Id is a dimensionless amount indicating how much the reflectance due to the main light has decreased with respect to the reflectance due to the reference light due to the diameter change of the reagent pad 22. It can be said that the smaller the index Id, the more the reagent pad 22 is deteriorated.

  The determination unit 40 reads the reference index Id0 stored in advance in the hard disk drive 19 or the memory 16, for example. The reference index Id0 is determined empirically from the index Id of the reagent pad 22 that can be appropriately measured or based on the result of a preliminary test. For example, in the case of the reagent pad 22 used by the inventors for the test, the index Id is normally about 0.97, and when a measurement failure due to deterioration is confirmed, the index Id is 0.7 to 0.85. Or less. In this case, the reference index Id0 is set to 0.90, for example. When the index Id is smaller than the reference index Id0, it is determined that the test piece 2 has deteriorated, and the process of step S107 is executed. On the other hand, when it is determined that the index Id is equal to or greater than the reference index Id0, it is determined that the test piece 2 is normal (that is, the quality has not deteriorated). In this case, this routine is once ended, and the above-described analysis program is executed.

  As shown in FIG. 2, the analysis apparatus 1 includes a notification device 39. In step S107 (notification step), the notification unit 38 controls the notification device 39 to notify the user of the deterioration state of the test piece 2. For example, when the test piece accommodation period ΔPoc exceeds the allowable exposure period ΔPoca and the index Id is smaller than the reference index Id0, the notification unit 38 has deteriorated the reagent pad 22 of the test piece 2 and the quality is high. Including the contents such as being lowered, there is a possibility that when the sample is analyzed using the test piece 2, there is an error in the measured value of each specific component, and the reliability of the analysis result may be lowered. Inform users of information. Note that the notification unit 38 positively confirms that the quality of the test piece 2 has not deteriorated when the test piece accommodation period ΔPoc is within the allowable exposure period ΔPoca, or when the index Id is equal to or greater than the reference index Id0. However, when the test piece 2 is in a normal state as described above, the user is not notified or warned itself, and only when the possibility that the test piece 2 is deteriorated is high. Notification may be performed. When the processing of this step is completed, this routine is temporarily ended, and the above-described analysis program is executed.

  When step S105 is executed, the test piece 2 is set at the position P1. The notification unit 38 preferably notifies the notification unit 39 of a message that prompts the user to remove the test piece 2 at the position P1. Instead of urging removal of the test piece 2, the test piece supply control unit 31 may have a function of returning the test piece 2 whose reflectance has been measured to the test piece supply unit 12.

  In the present embodiment, the photometric device control unit 33, the measurement unit 34, and the determination unit 40 constitute a deterioration determination unit in the present invention. Further, the remaining state determination unit 35, the period calculation unit 36, and the preliminary determination unit 37 constitute a preliminary determination unit in the present invention. Moreover, the alerting | reporting device 39 and the alerting | reporting part 38 which controls this alerting | reporting device 39 respond | corresponds to the alerting | reporting means in this invention.

  Next, the operation of the analyzer 1 will be described.

  According to the analyzer 1, the deterioration state of the test piece 2 is determined using the reflectance of the reagent pad 22 of the test piece 2 in a state before the sample is spotted. The reagent pad 22 is a part that is most deteriorated due to a change with time among the constituent elements of the test piece 2 and affects the analysis result. According to the inventors' research, it has been found that the reflectance of the reagent pad 22 is likely to change significantly due to deterioration such as moisture absorption. Therefore, prior to actually measuring the color reaction of the sample, the user can appropriately recognize that the test piece 2 has deteriorated.

  According to the inventors' research, it was found that the reagent pad 22 for measuring glucose in urine and the reagent pad 22 for measuring specific gravity of urine have particularly large changes in reflectance due to deterioration. By using the reflectance of these reagent pads 22 for determining the deterioration state, the deterioration state can be determined more appropriately. It should be noted that for both glucose and the specific gravity reagent pad 22, step S105 and step S106 are executed, and when the index Id based on the reflectance of both reagent pads 22 falls below the reference index Id0, the situation is deteriorated. It may be determined, or it may be determined that the condition is deteriorated when the index Id based on one of the reflectances falls below the reference index Id0. The reference index Id0 may be set to a dedicated value for each type of reagent pad 22.

  By using the main light having a wavelength at which the reflectance is likely to decrease due to the deterioration of the reagent pad 22 and the reference light at which the reflectance is difficult to decrease, the deterioration state of the test piece 2 can be more accurately determined. By making a determination based on the reflectance of the reference pad 23 in addition to the reflectance of the reagent pad 22, it is possible to prevent the determination of the deterioration state from being inaccurate due to a change in the light amount of the light source units 171a and 171b. . Note that the present invention is not limited to these, and for example, the reflectance may be measured using only the main light in the present embodiment to determine the deterioration state. Alternatively, the deterioration state may be determined using only the reflectance of the reagent pad 22 without using the reference pad 23.

  When the test piece 2 remains in the test piece storage unit 121 when the analyzer 1 is started, the deterioration state of the test piece 2 is preliminarily determined according to the test piece storage period ΔPoc, and then the test piece 2 Determine the degradation status of. Thereby, when there is almost no doubt about the deterioration of the test piece 2, it is possible to avoid performing the deterioration determination process in steps S105 and S106 in vain. Note that the analysis apparatus and the analysis method of the present invention are not limited to the configuration in which the deterioration state of the test piece 2 is determined based on the reflectance after the deterioration state is determined in advance, and the preliminary deterioration state is not determined. Alternatively, a configuration for determining the deterioration state based on the reflectance may be used.

(Modification 1)
Next, a modified example in the present embodiment will be described. FIG. 7 is a schematic configuration diagram of the test piece housing part 121 in the present modification. In the present modification, a temperature / humidity detection sensor 1213 for measuring the humidity and temperature of the accommodation space S1 (hereinafter collectively referred to as “temperature / humidity”) is installed in the test piece accommodation unit 121. . The temperature / humidity detection sensor 1213 includes a temperature sensor 1213A and a humidity sensor 1213B. The temperature sensor 1213A can be composed of, for example, a platinum resistance thermometer. This platinum resistance thermometer is well known and will not be described in detail, but is a type of resistance thermometer that utilizes the property that the electrical resistance of the metal changes with temperature change. This is a sensor using a small amount of platinum (Pt) as a temperature measuring element. However, the temperature sensor 1213A is not limited to this, and may be, for example, a temperature sensor employing a thermocouple type or other methods. Further, as the humidity sensor 1213B, for example, a capacitance type sensor may be used. In this modification, the temperature / humidity detection sensor 1213 corresponds to the exposure environment measuring means in the present invention. In this modification, even after the user turns off the power switch, the power supply to the temperature / humidity detection sensor 1213 can be continuously performed by the power stored in the battery (not shown). Upon receiving this power supply, the temperature / humidity detection sensor 1213 measures the temperature / humidity of the accommodation space S1 at regular intervals even during the test piece accommodation period ΔPoc. Other hardware configurations are the same as those of the analyzer described in the first embodiment.

  Here, the exposure environment to which the test piece 2 in the test piece storage unit 121 is exposed during the test piece storage period ΔPoc affects the degree of deterioration of the test piece 2. Therefore, in this modification, the allowable exposure period is variably set according to the detection result by the temperature / humidity detection sensor 1213. The measurement results of the temperature / humidity detection sensor 1213 are sequentially stored in the hard disk drive 19 as temperature history data and humidity history data.

  Referring to the control flow shown in FIG. 6, in step S103 in FIG. 6, in addition to calculating the specimen storage period ΔPoc, the allowable exposure period ΔPoca is set based on each of the above history data. Is done. That is, the preliminary determination unit 37 reads the temperature history data and the humidity history data corresponding to the most recent operation stop date / time to the most recent start date / time (test piece accommodation period ΔPoc) from the hard disk drive 19, and the test piece accommodation unit 121 in the period concerned. Calculate average temperature and average humidity.

  As the test piece 2 is exposed to a high temperature and high humidity environment, the degree of deterioration becomes more prominent. Therefore, if the humidity environment of the test strip housing part 121 is the same, the higher the average temperature in the test strip housing period ΔPoc, the shorter the allowable exposure period ΔPoca is set. Moreover, if the temperature environment of the test piece accommodating part 121 is equivalent, the set value of the allowable exposure period ΔPoca is set as a shorter period as the average humidity in the test piece accommodation period ΔPoc is higher. In this way, it is possible to accurately determine the deterioration state of the test piece 2 in accordance with the difference in the exposure environment to which the test piece 2 is exposed, and to check the quality with higher accuracy.

  Note that the analysis apparatus 1 in this modification includes the temperature sensor 1213A and the humidity sensor 1213B, but may include only one of the temperature sensor 1213A and the humidity sensor 1213B. For example, when only the temperature sensor 1213A is provided, the allowable exposure period ΔPoca may be set as a shorter period as the average temperature of the test piece container 121 in the test piece accommodation period ΔPoc is higher. Further, when the analyzer 1 includes only the humidity sensor 1213B, the allowable exposure period ΔPoca may be set as a shorter period as the average humidity of the test piece container 121 in the test piece accommodation period ΔPoc is higher.

  Further, instead of or in combination with the allowable exposure period ΔPoca according to the exposure environment in which the test piece 2 is exposed to the test piece accommodation period ΔPoc, the preliminary determination unit 37 determines the degree of deterioration of the test piece 2. Weighting may be performed according to the exposure environment. For example, the preliminary determination unit 37 may determine the degree of deterioration of the test piece 2 higher as the average temperature in the test piece storage period ΔPoc is higher as long as the humidity environment of the test piece storage unit 121 is the same. Similarly, if the temperature environment of the test strip container 121 is the same, the preliminary determination unit 37 may determine the degree of deterioration of the test strip 2 higher as the average humidity during the test strip storage period ΔPoc is higher. . This also makes it possible to accurately determine the deterioration state of the test piece 2 in accordance with the exposure environment to which the test piece 2 is exposed, and to confirm the quality with higher accuracy. In addition, in this modification, although the average value of the temperature (humidity) of the test piece accommodating part 121 is used as a representative value reflecting the exposure environment to which the test piece 2 is exposed, it is not limited to this. A maximum value or median value of (humidity) may be adopted.

<Example 2>
FIG. 8 shows a configuration block diagram of the analyzer 1 in the second embodiment, and FIG. 9 shows an internal structure of the analyzer 1 of the present embodiment. In the present embodiment, the analyzer 1 includes a preliminary photometric device 17A in addition to the photometric device 17. The preliminary photometric device 17A is used for measuring the reflectance in step S105 described above, and includes two light emitting units 171Aa and 171Ab and a light receiving unit 172A. The configuration of the light emitting units 171Aa and 171Ab is the same as that of the light emitting units 171a and 171b described above, and the configuration of the light receiving unit 172A is the same as that of the light receiving unit 172 described above. Further, the photometric device 17 of this embodiment is used for optically measuring the color reaction of the reagent pad 22 on which the sample is spotted. The photometric device 17 includes one light-emitting unit 171 that emits light having a wavelength suitable for measuring a color reaction.

  As shown in FIG. 9, the preliminary photometry device 17 </ b> A is provided at a position closer to the test strip supply unit 12 than the photometry device 17. The position P0 is a position where the test piece 2 measured by the preliminary photometry device 17A is to be disposed. Whether or not the test piece 2 is located at the position P0 is detected by, for example, the test piece sensor 124A.

  Even in such an embodiment, it is possible to appropriately determine the deterioration state of the test piece 2 as in the above-described embodiment. Further, no sample is spotted on the test piece 2 measured by the preliminary photometry device 17A at the position P0. For this reason, it is not necessary to make the nozzle 141 reach the test piece 2 at the position P0. Thereby, the position P0, that is, the preliminary photometry device 17A can be brought closer to the test strip supply unit 12. This is suitable for shortening the time until the determination of the deterioration state of the test piece 2 is completed. Further, when the test piece 2 determined not to be deteriorated as a result of the deterioration determination step in step S106 is returned to the test piece supply unit 12, there is an advantage that the return can be easily performed. In addition, it is good also as a structure which sends the test piece 2 determined not having deteriorated in step S106 to the position P1, and measures a color reaction. Further, the configuration of the modified example of the first embodiment described above may be applied to the second embodiment.

  As mentioned above, although embodiment of this invention was described, the analyzer which concerns on this invention and the analysis method are not restricted to these, These combinations can be included as much as possible. The above-described embodiment is an example for explaining the present invention, and various modifications can be made to the above-described embodiment without departing from the spirit of the present invention.

DESCRIPTION OF SYMBOLS 1 ... Analytical apparatus 2 ... Test piece 11 ... Apparatus main-body part 12 ... Test piece supply part 14 ... Sample spotting apparatus 15 ... CPU
16 ... Memory 17 ... Photometry device 17A ... Preliminary photometry device 21 ... Base material 22 ... Reagent pad 31 ... Test strip supply control unit 32 ... Spotting device control unit 33- ..Photometric device control unit 34... Measurement unit 35... Residual state determination unit 36 .. period calculation unit 37 .. preliminary determination unit 38. ..Rotating drum 141 ... Nozzle 1211 ... Open / close lid 1212 ... Open / close detection sensor 1213 ... Temperature / humidity detection sensor

Claims (13)

A test specimen container for accommodating the test specimen for analysis;
A sample spotting part for spotting a specimen on a reagent pad formed on the test specimen for analysis;
In an analyzer provided with an optical characteristic value measuring means for measuring an optical characteristic value of the reagent pad,
Deterioration determining means for determining the deterioration status of the test specimen for analysis based on the optical characteristic value of the reagent pad measured by the optical characteristic value measuring means and the sample spotting part not depositing a specimen; ,
Informing means for informing the user of the deterioration status of the test specimen for analysis determined by the deterioration determining means;
An analysis device comprising: The optical characteristic value measuring means includes two light emitting means for emitting light having different wavelengths.
The analyzer according to claim 1, wherein the deterioration determining unit determines based on optical characteristic values of the two light emitting units.   One of the two light emitting means emits main light in a wavelength range in which an optical characteristic value changes due to deterioration of the reagent pad, and the other of the two light emitting means has a change in optical characteristic value due to deterioration of the reagent pad. The analyzer according to claim 2, which emits reference light having a wavelength region smaller than that of the main light.   The analyzer according to any one of claims 1 to 3, wherein the reagent pad is for analyzing glucose in urine.   The analyzer according to any one of claims 1 to 3, wherein the reagent pad is for analyzing the specific gravity of urine. The optical property value measuring means further measures an optical property value of a reference pad formed on the analytical test piece,
The analyzer according to any one of claims 1 to 5, wherein the deterioration determining means determines based on an optical characteristic value of the reagent pad and an optical characteristic value of the reference pad.   The analyzer according to claim 6, wherein the reference pad is white.   8. The color reaction measurement device according to claim 1, further comprising a color reaction measurement unit that measures a color reaction of the reagent pad on which the specimen is spotted and also serves as the optical characteristic value measurement unit. Analysis equipment.   8. A color reaction measurement unit that measures a color reaction of the reagent pad on which a specimen is spotted and that is separate from the optical characteristic value measurement unit. 2. The analyzer according to item 1. A test piece container for accommodating the test specimen for analysis;
Preliminary determination means for determining whether or not the optical characteristic value measurement by the optical characteristic value measurement means and determination by the deterioration determination means are necessary based on the storage period of the test specimen for analysis in the test piece storage section;
The analyzer according to any one of claims 1 to 9, further comprising:   The analyzer according to claim 10, wherein the preliminary discriminating unit discriminates based on whether or not an accommodation period of the analysis test piece exceeds an allowable exposure period. Further comprising an exposure environment measuring means for measuring at least one of humidity and temperature in the test piece container,
The preliminary determination means determines whether or not the storage period of the analytical test specimen exceeds an allowable exposure period,
The analysis apparatus according to claim 10, wherein the allowable exposure period is variably set according to a measurement result by the exposure environment measurement unit. An optical characteristic value measuring step for measuring an optical characteristic value of the reagent pad in a state where the specimen has not yet been deposited on the reagent pad formed on the test specimen for analysis;
A deterioration determining step of determining a deterioration state of the test specimen for analysis based on the optical characteristic value measured by the optical characteristic value measuring step;
An informing step for informing the user of the deterioration status of the test specimen for analysis determined by the deterioration determining step;
Perform the analysis method.

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